august 5 - 6, 2015, baltimore, md

Technical Committee on Hyperbaric and Hypobaric Facilities

(HEA-HYP)

M E M O R A N D U M

DATE: July 21, 2015

TO: Principal and Alternate Members of the Technical Committee on Hyperbaric and

Hypobaric Facilities (HEA-HYP)

FROM: Jon Hart, Staff Liaison

SUBJECT: AGENDA PACKAGE– NFPA 99 and NFPA 99B First Draft Meeting

(A2017)

________________________________________________________________________

Enclosed is the agenda for the NFPA 99 and 99B First Draft meeting of the Technical Committee

on Hyperbaric and Hypobaric Facilities, which will be held on Wednesday, August 5, and

Thursday, August 6, 2015 at the Sheraton Inner Harbor Hotel, in Baltimore, MD. Please

review the attached Public Inputs in advance, and if you have alternate suggestions, please come

prepared with proposed language and respective substantiation.

If you have any questions prior to the meeting, please do not hesitate to contact me at:

Office: (617) 984-7470

Email: [email protected]

For administrative questions, please contact Elena Carroll at (617) 984-7952.

I look forward to working with everyone.

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mailto:[email protected]

Table of Contents

Part 1 – Meeting Agenda

Part 2 – Committee Roster

Part 3 – Committee Distribution

Part 4 – Previous Meeting Minutes

Part 5 – Sample Meeting Motions

Part 6 – Public Inputs

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Technical Committee on Hyperbaric and Hypobaric

Facilities (HEA-HYP) NFPA 99 First Draft Meeting (Annual 2017)

Wednesday, August 5, 2015 - Thursday, August 6, 2015

Sheraton Inner Harbor Hotel 300 S. Charles Street, Baltimore, MD 21201

AGENDA

1. Call to Order – 8:00 am (8/5)

2. Introductions and Attendance

3. Chairman Comments

4. Approval of Previous Meeting Minutes

5. Staff Liaison Presentation on NFPA’s Revision Process and A2017 Cycle

6. Preparation of the First Draft for NFPA 99

Review Public Inputs

Create First Revisions

7. Preparation of First Draft for NFPA 99B

Review Public Inputs

Create First Revisions

8. New Business

9. Discuss dates for the TC Second Draft Meeting (Between 5/16 and 7/25, 2016)

10. Adjournment – No later than 5:00 pm (8/6)

Please submit requests for additional agenda items to the chair and staff liaison at least

seven days prior to the meeting.

Please notify the chair and staff liaison as soon as possible if you plan to introduce any new

material not submitted through Public Input at the meeting.

3

Technical Committee on Hyperbaric and Hypobaric

Facilities (HEA-HYP) NFPA 99 First Draft Meeting (Annual 2017)

Wednesday, August 5, 2015 - Thursday, August 6, 2015

Sheraton Inner Harbor Hotel 300 S. Charles Street, Baltimore, MD 21201

Key Dates for the Annual 2017 Revision Cycle

Public Input Closing Date July 6, 2015

Final Date for First Draft Meeting September 14,

2015

Ballots Mailed to TC before October 26, 2015

Ballots Returned By November 16, 2015

Correlating Committee First Draft Meeting December 15, 2015

Final First Draft Posted March 7, 2016

Public Comment Closing Date May 16, 2016

Final Date for Second Draft Meeting July 25, 2016

Correlating Committee Second Draft Meeting by November 21, 2016

Final Second Draft Posted January 16, 2017

Closing Date for Notice of Intent to Make a Motion

(NITMAM) February 20, 2017

Issuance of Consent Document (No NITMAMs) May 12, 2017

NFPA Annual Meeting (Boston) June 2017

Issuance of Document with NITMAM August 10, 2017

Technical Committee deadlines are in bold.

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Technical Committee Roster

5

Address List No PhoneHyperbaric and Hypobaric Facilities HEA-HYP

Health Care Facilities

Jonathan Hart07/13/2015

HEA-HYP

James Bell

ChairIntermountain HealthcareIntermountain Medical Ctr/Hyperbaric Medicine5121 South Cottonwood StreetMurray, UT 84517

U 1/10/2008HEA-HYP

Michael W. Allen

PrincipalLife Support Technologies Group Inc.Hyperbaric Medical Technologies, Inc.504 St. Lawrence WayFurlong, PA 18925Alternate: Mark Chipps

U 10/4/2001

HEA-HYP

Peter Atkinson

PrincipalRoyal Brisbane and Womens HospitalHyperbaric Medicine ServiceNed Hanlon Bldg., Ground FloorRBWH, Butterfield StreetHerston, QLD 4029 AustraliaHyperbaric Technicians & Nurses Association Inc.Alternate: Justin Callard

C 7/20/2000HEA-HYP

Richard C. Barry

PrincipalHealogics5220 Belfort Road, Suite 130Jacksonville, FL 32256

SE 4/15/2004

HEA-HYP

Chad E. Beebe

PrincipalASHE - AHAPO Box 5756Lacey, WA 98509-5756American Society for Healthcare Engineering

U 03/05/2012HEA-HYP

W. Robert Bryant

PrincipalPerry Baromedical Corporation11610 Aspenway DriveHouston, TX 77070

M 8/2/2010

HEA-HYP

Mario Caruso

PrincipalHyperbaric Consulting LLC3231 Glenwood CircleHoliday, FL 34691-2545

SE 7/26/2007HEA-HYP

Keith Ferrari

PrincipalPraxair, Inc.2807 Gresham Lake RoadRaleigh, NC 27615

M 1/25/2007

HEA-HYP

W. T. Gurnée

PrincipalOxyHeal Health Group3224 Hoover AvenueNational City, CA 91950Alternate: Michael P. Powers

M 10/10/1998HEA-HYP

Barry E. Newton

PrincipalWHA International, Inc.5605 Dona Ana RoadLas Cruces, NM 88007-5953

SE 7/24/1997

HEA-HYP

Kevin A. Scarlett

PrincipalWashington State Department of Health1701 North Mildred StreetTacoma, WA 98406NFPA Health Care Section

E 10/23/2013HEA-HYP

Robert B. Sheffield

PrincipalInternational ATMO, Inc.414 Navarro, Suite 502San Antonio, TX 78205Alternate: Kevin I. Posey

U 1/17/1997

HEA-HYP

John M. Skinner

PrincipalMedical Equipment Technology, Inc.2723 Brickton North DriveBuford, GA 30518

IM 3/15/2007HEA-HYP

Deepak Talati

PrincipalSechrist Industries, Inc.4225 East LaPalma AvenueAnaheim, CA 92807

M 10/27/2009

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Address List No PhoneHyperbaric and Hypobaric Facilities HEA-HYP

Health Care Facilities

Jonathan Hart07/13/2015

HEA-HYP

Wilbur T. Workman

PrincipalUndersea & Hyperbaric Medical Society14607 San Pedro Avenue, Suite 270San Antonio, TX 78232

U 1/1/1984HEA-HYP

Justin Callard

AlternateHyperbaric Technicians & Nurses Association Inc.Pow Hospital, RandwickSydney, NSW 2031 AustraliaPrincipal: Peter Atkinson

C 03/07/2013

HEA-HYP

Mark Chipps

AlternateLife Support Technologies Group Inc.314 West 2nd StreetWest Islip, NY 11795Principal: Michael W. Allen

U 10/29/2012HEA-HYP

Kevin I. Posey

AlternateInternational ATMO, Inc.414 Navarro Street, Suite 502San Antonio, TX 782905Principal: Robert B. Sheffield

U 10/27/2009

HEA-HYP

Michael P. Powers

AlternateOxyHeal Health GroupHartford Hospital80 Seymour Street, CB 105Hartford, CT 06102Principal: W. T. Gurnée

M 10/29/2012HEA-HYP

Jonathan Hart

Staff LiaisonNational Fire Protection Association1 Batterymarch ParkQuincy, MA 02169-7471

3/1/2012

27

Technical Committee

Distribution

8

Monday 7 13, Monday

Hyperbaric and Hypobaric FacilitiesHEA-HYPName Representation Class Office

Distribution by %

Company

Peter Atkinson Royal Brisbane and Womens Hospital HTNA C Principal

1Voting Number Percent 7%

Kevin A. Scarlett Washington State Department ofHealth

NFPA/HCS E Principal


John M. Skinner Medical Equipment Technology, Inc. IM Principal


W. Robert Bryant Perry Baromedical Corporation M Principal

Keith Ferrari Praxair, Inc. M Principal

W. T. Gurnée OxyHeal Health Group M Principal

Deepak Talati Sechrist Industries, Inc. M Principal


Richard C. Barry Healogics SE Principal

Mario Caruso Hyperbaric Consulting LLC SE Principal

Barry E. Newton WHA International, Inc. SE Principal


James Bell Intermountain Healthcare U Chair

Michael W. Allen Life Support Technologies Group Inc. U Principal

Chad E. Beebe ASHE - AHA ASHE U Principal

Robert B. Sheffield International ATMO, Inc. U Principal

Wilbur T. Workman Undersea & Hyperbaric MedicalSociety

UHMS U Principal


15Total Voting Number

9

Previous Meeting Minutes

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MINUTES NFPA Technical Committee on Hyperbaric and Hypobaric Facilities

(HEA-HYP) May 23 + 24, 2013

Second Draft Meeting Downtown Marriott at the Convention Center – New Orleans, LA

1. Call to Order. The meeting was called to order at 8:00 am on Thursday May 23, 2013 by Committee Chair, Robert Sheffield.

2. Attendance and Introductions: Attendance was taken and those present at the meeting introduced themselves and stated who they represent on the committee. Those who were present at the meeting are listed below:

Name Representing

Sheffield, Robert – Chair International ATMO, Inc.

Barry, Richard – Principal Diversified Clinical Services & National Healing

Beebe, Chad – Principal American Society for Healthcare Engineers

Bell, James – Principal Intermountain Healthcare

Bryant, W. Robert – Principal Perry Baromedical Corporation

Ferrari, Keith – Principal Praxair, Inc.

Fuqua, Angela – Principal Chubb Group Insurance Companies

Skinner, John – Principal (web) Medical Equipment Technology, Inc.

Talati, Deepak – Principal (web) Sechrist Industries, Inc.

Workman, Tom – Principal Undersea & Hyperbaric Medical Society

Chipps, Mark – Alternate Life Support Technology Group Inc.

Hart, Jonathan – Staff Liaison NFPA

Bielen, Richard – NFPA Staff NFPA

Duffy, John – Guest Healogics, Inc.

Garay, Adrian – Guest (Web) OxyHeal Health Group

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3. Chairman Comments: Robert Sheffield spoke to the agenda for the meeting and provided opening comments.

4. Minutes Approval: The minutes of the HEA-HYP August 20 and 21, 2012 First Draft Meeting were approved as distributed in the Agenda Package.

5. Staff Liaison Presentation: Jon Hart gave the staff presentation for the meeting which included general meeting procedures and a review of the Annual 2014 revision cycle.

6. Development of First Draft: The committee reviewed all public comments (PC) under their jurisdiction for NFPA 99 and NFPA 99B and resolved it by either providing a committee statement or by creating a second revision (SR) based on the PC. Other Second Revisions were also created. See the Second Draft and Second Draft report for the official committee actions on each document.

7. New Business: There was no new business.

8. Meeting Adjourned: The meeting was adjourned at 12:10 pm on May 24, 2013.

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Sample Motions for

First Draft Meeting

13

NEW PROCESS ACTIONS AND MOTIONS

Possible Action #1: Resolve PI (no change to section)

Action Required Sample motion

Make a statement to resolve a PI I move to resolve PI # with the following

statement . . .

Possible action #2: Create First Revision (make a change to a section)

Action Required Sample motion

Step 1 Create a First revision based one or more

PIs I move to create a First Revision based on PI #

Step 2 If the revision is related to multiple PIs, generate a statement to respond to all of

them together

Step 1 Create a First Revision I move to create a First Revision as follows . . .

Step 2 Generate a statement (substantiation)

Possible Action 3: Create Committee input

Step 1 Create proposed revision for solicitation

of public comments I move to create CI with a proposed revision to X

as follows . . .

Step 2 Generate a statement to explain the

intent and why the Committee is seeking public comment

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Public Input

(NFPA 99)

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Public Input No. 48-NFPA 99-2015 [ New Section after 3.3.73 ]

Hyperbaric Operations defined.3.i.i.i Hyperbaric Operations. Procedures conducted on the patient receiving hyperbaric treatment to include: (a) therapy inside a hyperbaricchamber, (b) changing clothes, (c) vital signs, (d) non-invasive transcutaneous oxygen monitoring, (e) clinical and medical assessments, and (f)minor dressing changes. [Debridement or other surgical procedures, application of casting material, application of skin substitutes, and application ofbio-engineered grafts are not permitted in the chamber room.] (HYP)

Additional Proposed Changes

File Name Description ApprovedPC_38_HYP.pdf NFPA 99_PC38 ✓

Statement of Problem and Substantiation for Public Input

NOTE: The following Public Input appeared as “Reject but Hold” in Public Comment No. 38 of the (A2014) Second Draft Report for NFPA 99 and per the Regs. At 4.4.8.3.1.Defining Hyperbaric Procedures affords the AHJs and end users an understanding of the activities allowed in the hyperbaric room.

Submitter Information Verification

Submitter Full Name: TC ON HEA-HYPOrganization: NFPAStreet Address:City:State:Zip:Submittal Date: Thu Apr 09 14:21:33 EDT 2015

National Fire Protection Association Report http://submittals.nfpa.org/TerraViewWeb/FormLaunch?id=/TerraView/C...

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Public Input No. 459-NFPA 99-2015 [ Chapter 14 ]

Chapter 14 Hyperbaric Facilities

14.1* Scope.

The scope of this chapter shall be as specified in 1.1.12.

14.1.1 Applicability.

14.1.1.1

This chapter shall apply to new facilities.

14.1.1.2

The following sections of this chaptershall apply to both new and existing facilities:

(1) 14.2.4.1.1 (excluding subsections)

(2) 14.2.4.1.1.1

(3) 14.2.4.1.2

(4) 14.2.4.1.3 (excluding subsections)

(5) 14.2.4.1.3.3

(6) 14.2.4.3.3 (and subsections)

(7) 14.2.4.4 (and subsections)

(8) 14.2.4.5.3

(9) 14.2.4.5.4 (and subsection)

(10) 14.2.5.1.4 (excluding subsection)

(11) 14.2.5.1.5

(12) 14.2.5.1.7

(13) 14.2.5.5 (and subsection)

(14) 14.2.7.1

(15) 14.2.7.2 (and subsection)

(16) 14.2.8.3 through 14.2.8.3.5

(17) 14.2.8.3.9 (and subsection)

(18) 14.2.8.3.15.4

(19) 14.2.8.3.16.5

(20) 14.2.8.3.17 (and subsections)

(21) 14.2.8.4.1.3

(22) 14.2.8.6 (and subsections)

(23) 14.2.9.3 through 14.2.9.8 (and subsections)

(24) 14.2.10.2.5

(25) 14.3.1 (and subsections)

(26) 14.3.2.1.1 through 14.3.2.1.8

(27) 14.3.2.4 through 14.3.2.6 (and subsection)

(28) 14.3.3 through 14.3.6 (and subsections)

14.1.1.3

This chapter shall also apply to the altered, renovated, or modernized portion of an existing system or individual component.

14.1.1.4

Existing construction or equipment shall be permitted to be continued in use when such use does not constitute a distinct hazard to life.

14.1.2 Classification of Chambers.

14.1.2.1 General.

Chambers shall be classified according to occupancy in order to establish appropriate minimum essentials in construction and operation.

14.1.2.2* Occupancy.

Hyperbaric chambers shall be classified according to the following criteria:

(1) Class A — Human, multiple occupancy

(2) Class B — Human, single occupancy

(3) Class C — Animal, no human occupancy

14.1.3 Category of Care.

14.1.3.1 Category 1 Care.

Where interruption or failure of medical gas supply is likely to cause major injury or death of patients, staff, or visitors, the level of care shall beconsidered Category 1 in the requirements for medical gas systems in hyperbaric facilities.

National Fire Protection Association Report http://submittals.nfpa.org/TerraViewWeb/ContentFetcher?commentPara...

49 of 133 7/8/2015 3:18 PM

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jhart

Text Box

Note: This Public Input pulled in all of Chapter 14 without any recommended changes. The middle 17 pages have been removed from the agenda package in order to help reduce the size of the agenda.

14.3.6.3 Fire Protection Equipment Inside Hyperbaric Chambers.

14.3.6.3.1

Electrical switches, valves, and electrical monitoring equipment associated with fire detection and extinguishment shall be visually inspectedbefore each chamber pressurization.

14.3.6.3.2

Fire detection equipment shall be tested each week, and full testing, including discharge of extinguishing media, shall be conducted annually.

14.3.6.3.3

Testing shall include activation of trouble circuits and signals.

14.3.6.4* Housekeeping.

A housekeeping program shall be implemented, whether or not the facility is in regular use.

14.3.6.4.1

The persons assigned to the task of housekeeping shall be trained in the following:

(1) Potential damage to the equipment from cleaning procedures

(2) Potential personal injury

(3) Specific cleaning procedures

(4) Equipment not to be cleaned


File Name Description Approved2014_FGI_HOP_hyberbaric_facilities.docx FGI Guidelines section on Hyperbaric


This chapter needs to be coordinate with the FGI Guidelines chapter. The FGI is adopted in over 40 states and it is confusing to have different standards that conflict. with quick review I didn't see any major changes that would be needed in NFPA 99. It appears that changes, if any, may need to be submitted to FGI which is accepting public input until early October.


Submitter Full Name: CHAD BEEBE

Organization: ASHE - AHA

Street Address:City:State:Zip:Submittal Date: Mon Jul 06 15:27:04 EDT 2015


67 of 133 7/8/2015 3:18 PM

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Carroll, Elena

From: Pamela Blumgart <[email protected]>Sent: Wednesday, July 15, 2015 10:03 AMTo: Carroll, ElenaCc: Chad E. Beebe; Doug EricksonSubject: Re: NFPA 99 (A2017) PI Attachments - Copyright Permission

I am following up a request from Chad Beebe to send NFPA permission to use some FGI content in development of NFPA 99. Please see the following, and let me know if you have any questions.

The Facility Guidelines Institute (FGI) grants NFPA permission to include the following excerpts from the 2014 FGI Guidelines for Design and Construction of Hospitals and Outpatient Facilities in drafts of the 2017 edition of NFPA 99: Health Care Facilities Code that are submitted for public review:

Section 2.1‐8.3.7, Call Systems Section 2.1‐8.5, Communications Systems Table 2.1‐2, Locations of Nurse Call Devices in Hospitals Section 2.2‐3.13, Hyperbaric Suite

Published editions of NFPA 99 will include cross‐references to this material from the 2014 FGI Guidelines.

In accordance with the referencing procedures adopted in NFPA standards, the original document for the referenced material listed above shall be identified as follows:

Facility Guidelines Institute, 2014, Guidelines for Design and Construction of Hospitals and Outpatient Facilities (Chicago: American Society for Healthcare Engineering).

Pamela James Blumgart Managing Editor Facility Guidelines Institute www.fgiguidelines.org [email protected] 202‐286‐3258

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2.2-3.13 Hyperbaric Suite

2.2-3.13.1 Hyperbaric Treatment Area

2.2-3.13.1.1 General

(1) This section shall apply to hyperbaric facilities designated for clinical hyperbaric oxygen therapy.

(2) The hyperbaric treatment area shall meet the requirements of the “Hyperbaric Facilities” chapter in

NFPA 99: Health Care Facilities Code.

*2.2-3.13.1.2 Hyperbaric chambers. Hyperbaric chambers shall meet the requirements in this section in

addition to those of NFPA 99: Health Care Facilities Code.

A2.2-3.13.1.2 For additional information on the design of hyperbaric chambers

and the rooms that chambers are housed in, contact the Undersea and Hyperbaric

Medical Society (www.uhms.org).

(1) Multiplace (Class A chamber) facilities

(a) Area. The space provided to house Class A chambers and supporting equipment shall

accommodate the equipment manufacturer’s technical specifications, but shall not be less than the

space required to meet the clearances in paragraph (b).

(b) Clearances. There shall be a minimum clearance of 3 feet (914 mm) around the chamber except as

follows:

(i) Stretcher or gurney access. The area in front of chamber entries designed for gurney or

stretcher access shall have a minimum clearance of 8 feet (2.44 meters) for gurney or

stretcher approach.

(ii) Wheelchair access. The area in front of chamber entries designed for ambulatory or

wheelchair access only shall have a minimum clearance of 5 feet (1.52 meters) for wheelchair

approach.

(c) Entries

(i) Entries designed for wheelchairs or wheeled gurneys shall be provided with access ramps that

are flush with the chamber entry doorway.

*(ii) Chamber entries not designed for gurney/stretcher access shall be a minimum of 3 feet

(91.44 centimeters).

2.2-3.13.1.2 (1)(c)(ii) Chamber entries not designed for gurney or stretcher

access are locks or entry compartments with a circular entry hatchway or door.

(2) Monoplace (Class B chamber) facilities

(a) Area. The space provided to house Class B chambers and supporting equipment shall

accommodate the equipment manufacturer’s technical specifications, but shall not be less than the

space required to provide the clearances in paragraph (b).

(b) Clearances. There shall be a minimum clearance of 2 feet (610 mm) around the chamber except as

follows:

(i) A minimum clearance of 3 feet (914 mm) shall be provided between the control sides of two

chambers.

(ii) A minimum passage of 12 inches (305 mm) shall be provided at the foot end of each chamber

and any wall or obstruction.

(iii) The area in front of the chamber entry shall be designed for gurney or stretcher access. A

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http://www.uhms.org/

minimum clearance of 8 feet (2.44 meters) shall be provided for gurney or stretcher approach.

*(c) An oxygen service valve shall be provided for each chamber.

A2.2-3.13.1.2 (2)(c) The oxygen service shutoff valve is provided for facility

startup and shutdown as well as for service of the chamber without needing to

shut down all chambers in the area. This is in addition to a zone valve that is

required to the room that controls the oxygen flow to the entire room. The service

valve should be located so it is visible and accessible to the chamber operators,

unlike service valves required by NFPA 99, which are permitted to be secured

behind locked doors or located in the ceiling.

2.2-3.13.2 – 2.2-3.13.3 Reserved

2.2-3.13.4 Pre-Procedure Patient Care Area

A patient holding area shall be provided.

2.2-3.13.4.1 General

(1) The patient holding area shall be under staff control and out of the traffic flow from the chamber. It

shall not obstruct access to the exits from the hyperbaric suite.

(2) Stretcher patients in the holding area shall be out of the direct line of normal traffic.

(3) Omission of the patient holding area shall be permitted for facilities housing two or fewer Class B

hyperbaric chambers.

2.2-3.13.4.2 Space requirements. The patient holding area shall be sized to accommodate inpatients on

stretchers or beds.

2.2-3.13.4.3 Medical gas requirements. See Table 2.1-4 (Station Outlets for Oxygen, Vacuum, and

Medical Air Systems in Hospitals).

2.2-3.13.5 Support Areas—General

2.2-3.13.5.1 For general requirements, see Section 2.1-2.5 (Support Areas for Patient Care—General).

2.2-3.13.5.2 If the hyperbaric facility is included as an integral portion of another service such as a wound

care department, support areas shall be permitted to be shared.

2.2-3.13.6 Support Areas for the Hyperbaric Suite

The support areas in Section 2.2-3.12.6 (Support Areas for the Chemotherapy Infusion Center) shall be

provided for the hyperbaric facility as amended in this section.

2.2-3.13.6.1 Reception/control desk

2.2-3.13.6.2 – 2.2-3.13.6.3 Reserved

2.2-3.13.6.4 Consultation/treatment room(s). Room(s) for individual consultation and treatment shall

be provided.

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2.2-3.13.6.5 – 2.2-3.13.6.10 Reserved

2.2-3.13.6.11 Equipment and supply storage

(1) Clean linen and supply storage. Storage shall be provided for clean supplies and linens. When a

separate supply storage room is provided, it shall be permitted to be shared with another department.

(2) Gas cylinder room

(a) A gas cylinder room shall be provided with, at minimum, space to house eight (H) cylinders and

two gas manifolds, consisting of at least two (H) cylinders on each manifold.

(b) If dedicated medical gases are not provided from another area of the facility, this room shall be

large enough to accommodate storage of enough (H) cylinders and manifolds for the reserve

medical gases required for chamber operations.

2.2-3.13.6.12 Environmental services room. An environmental services room shall be provided in

accordance with Section 2.1-2.6.12 (Environmental Services Room) as amended in this section.

(1) The environmental services room shall be immediately accessible to the hyperbaric suite.

(2) When a separate storage room for housekeeping supplies is provided, it shall be permitted to be shared

with another department.

2.2-3.13.6.13 Compressor room

(1) The compressor room shall be large enough to house the chamber compressors, accumulator tanks,

and fire suppression system and allow them to meet the requirements of the NFPA 99 "Hyperbaric

Facilities" chapter.

(2) Reserve breathing gases shall be permitted to be housed in the compressor room if the room is located

in close proximity to the chamber room.

2.2-3.13.7 Support Areas for Staff

A toilet room(s) with hand-washing station(s) that meets the requirements in Section 2.1-2.6.5 (Hand-

Washing Station) shall be immediately accessible to the hyperbaric suite for staff use.

2.2-3.13.8 Support Areas for Patients

2.2-3.13.8.1 Patient waiting area

(1) The patient waiting area shall be screened from unrelated traffic, under staff control, and separated

from the hyperbaric suite by a door.

(2) Space requirements

(a) Seating capacity shall be provided to accommodate the maximum expected patient volume.

(b) If the waiting area will also be used as a patient holding area, it shall be large enough to

accommodate the clinical program and chamber mix; see Section 2.2-3.13.4 (Pre-Procedure

Patient Care Area).

(3) If the hyperbaric suite is routinely used for outpatients and inpatients at the same time, outpatient

waiting and inpatient holding areas shall be separated and screened to provide visual and acoustic

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privacy between them.

(4) Omission of the patient waiting area shall be permitted for facilities with two or fewer Class B

hyperbaric chambers.

2.2-3.13.8.2 Patient changing rooms

(1) Changing rooms for outpatients shall be provided and shall include:

(a) A seat or bench made of non-absorbable material

(b) A mirror

(c) Provisions for hanging patients' clothing and for securing valuables.

(2) At least one changing room that can accommodate wheelchair patients shall be provided.

2.2-3.13.8.3 Patient toilet room. A toilet room(s) with a hand-washing station(s) that meets the

requirements in Section 2.1-2.6.5 (Hand-Washing Station) shall be directly accessible to the hyperbaric

suite.

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Public Input No. 342-NFPA 99-2015 [ New Section after 14.1 ]

New: 14.1.1 ScopeHyperbaric facilities that are conducting any form of medical treatment, and or not located in a designated health care facility, including residentialoccupancies, shall comply with the requirements of the current edition of NFPA 101, Life Safety Code, sections 8.7.5 and A8.7.5.


Beginning with the 2000 edition of NFPA 101, Life Safety Code, compliance to the hyperbaric facility chapter of NFPA 99, Health Care Facilities, has been mandated by reference. This action was taken as a result of a number of hyperbaric treatment centers that were opening across the country in business occupancies such as strip shopping malls, etc. In some instances, the owners of these businesses were able to successfully argue that since they were not housed in a health care occupancy, they did not need to comply with the hyperbaric requirements of NFPA 99 even though they were conducting patient treatments. The NFPA is to be applauded for taking such an action. In doing so, they were very specific in stating that compliance was expected in all occupancy classifications.

Here we are 15 years later and what has changed? The number of hyperbaric facilities, both those located in health care occupancies and non-health care occupancies, has grown significantly. At the time the 2000 edition of NFPA 101 was issued there were approximately 500 hyperbaric facilities located in health care occupancies. There are now over 1200. Facilities in health care occupancies are not the issue as they are generally compliant with NFPA 99 and have extensive oversight. The problem resides in those facilities that are located in non-health care occupancies such as spas, business offices, malls, homes and, in one instance, even a church! These locations have no comprehensive oversight. Unfortunately, there is no way of knowing how many of these facilities exist as there is no mandatory reporting system in place for them. Even though the NFPA 101 reference to NFPA 99 has existed since 2000, it does not appear to be well-known. Perhaps this is so because there is no link in NFPA 99 to point AHJs to NFPA 101.

While some of these non-health care facilities use traditional hyperbaric chambers, which are well-regulated, there are an alarming number that are using what is generally called a “soft” hyperbaric chamber. These chambers are Class II medical devices that have been cleared by the FDA for the treatment of acute mountain sickness but are being used almost exclusively for a number of off-label indications such as autism, stroke, cerebral palsy, etc. This is not the point of the substantiation however. The point is that they do not meet any of the code requirements of NFPA 99. They do not comply with ASME PVHO-1 nor are they installed in accordance to the code………there is no installation required. They are portable and can be operational in less than 15 to 20 minutes. There is no mechanism to alert the AHJ that such a chamber is coming into their jurisdiction so they come in under the radar. How they are being used is a greater concern. They are frequently used with oxygen concentrators (in violation of FDA restrictions) and the use of a variety of electronic devices such as iPads, iPods, laptop computers, etc. while inside the chamber is commonly promoted. This is a well-known fire hazard. It is reported that there have been more than 10,000 of these types of chambers sold.

In 2011, a young 19 y.o. male died while inside one these “soft” chambers. The chamber was installed in his home and it was his custom to sleep in the chamber each night. One evening the chamber air supply became disconnected from the chamber and the young man suffocated. Had this type of chamber being used in the home environment been regulated perhaps this death would not have occurred.

The primary purpose of this input is to highlight the NFPA 101 requirement so that it is more widely known among the AHJ community.


Submitter Full Name: WILBUR WORKMAN

Organization: Undersea & Hyperbaric Medical Society

Affilliation: Undersea & Hyperbaric Medical Society

Street Address:City:State:Zip:Submittal Date: Sat Jul 04 13:43:53 EDT 2015


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Public Input No. 323-NFPA 99-2015 [ Section No. 14.1.3 ]

14.1.3 Category of Care.


14.1.3.1.1

Where interruption or failure of medical gas supply is likely to cause major injury or death of patients, staff, or visitors, the level of care shall beconsidered Category 1 in the requirements for medical gas systems in hyperbaric facilities.

14.1.3. 1. 2

Where interruption or failure of electrical service is likely to cause major injury or death of patients, staff, or visitors, the level of care shall beconsidered Category 1 in the requirements for electrical service in hyperbaric facilities.


14.1.3.2.1

Where interruption or failure of medical gas supply is likely to cause minor injury of patients, staff, or visitors, the level of care shall be consideredCategory 2 in the requirements for medical gas systems in hyperbaric facilities.

14.1.3. 2.2

Where interruption or failure of electrical service is likely to cause minor injury of patients, staff, or visitors, the level of care shall be consideredCategory 2 in the requirements for electrical service in hyperbaric facilities.

14.1. 3 .3 Category 3 Care.

14.1.3.3.1

Where interruption or failure of medical gas supply is not likely to cause injury to patients, staff, or visitors, the level of care shall be consideredCategory 3 in the requirements for medical gas systems in hyperbaric facilities.

14.1.3. 3.2

Where interruption or failure of electrical service is not likely to cause injury to patients, staff, or visitors, the level of care shall be consideredCategory 3 in the requirements for electrical service in hyperbaric facilities.

14.1.3. 4 Category 4 Care. (Reserved)


The electrical service requirements of hyperbaric facilities should be based on the relative risk of losing electrical power. This risk varies with the types of chamber equipment and acuity of patients treated.

Related Public Inputs for This Document

Related Input RelationshipPublic Input No. 324-NFPA 99-2015 [Section No. 14.2.8.2]


Submitter Full Name: ROBERT SHEFFIELD

Organization: INTERNATIONAL ATMO INC

Street Address:City:State:Zip:Submittal Date: Thu Jul 02 17:27:25 EDT 2015


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Public Input No. 47-NFPA 99-2015 [ Section No. 14.2.1.1.7 ]

14.2.1.1.7

When used for hyperbaric procedures, the room or rooms housing the Class A or Class B chambers shall be for the exclusive use of thehyperbaric operation.

Add Annex Note: A.14.2.1.1.7.Precautions should bein place for monitoring of items used to prepare a patient or staff member forentry into thehyperbaric chamber to prevent the entry of prohibited items intothe hyperbaric chamber.


File Name Description ApprovedPC_38_HYP.pdf NFPA 99_PC38


NOTE: The following Public Input appeared as “Reject but Hold” in Public Comment No. 38 of the (A2014) Second Draft Report for NFPA 99 and per the Regs. At 4.4.8.3.1.Defining Hyperbaric Procedures affords the AHJs and end users an understanding of the activities allowed in the hyperbaric room.


Submitter Full Name: TC ON HEA-HYP

Organization: NFPA

Street Address:City:State:Zip:Submittal Date: Thu Apr 09 14:17:17 EDT 2015


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Public Input No. 531-NFPA 99-2015 [ Section No. 14.2.1.2 [Excluding any Sub-Sections] ]

A hydraulically calculated automatic wet pipe sprinkler system meeting the requirements of NFPA 13, Standard for the Installation of SprinklerSystems, or an an automatic water mist fire protection system installed in accordance with NFPA 750, Standard on Water Mist Fire ProtectionSystems, a wet chemical extinguishing system per NFPA 17A, or a clean agent system shall be installed in the room housing a Class A, ClassB, or Class C chamber and in any ancillary equipment rooms.


There are development in fire system equal to better than wet sprinkler sytems


Submitter Full Name: DEEPAK TALATI

Organization: SECHRIST INDUSTRIES INC



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Public Input No. 410-NFPA 99-2015 [ New Section after 14.2.1.2.1 ]

14.2.1.2.2The room housing a Class A, Class B, or Class C chamber shall contain a minimum of one portable fire extinguisher.


Currently there is no required for a portable fire extinguisher to be located in the room housing hyperbaric chambers Class A, Class B, or Class C.


Submitter Full Name: RICHARD BARRY

Organization: HEALOGICS

Street Address:City:State:Zip:Submittal Date: Sun Jul 05 22:02:01 EDT 2015


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14.2.1.4.4 General.

Where an oxygen system is installed for hyperbaric treatments, it shall comply with the requirements for the appropriate level as determined in14.2.1.4.4.2 through 14.2.1.4.4.7 .

14.2.1.4.4.1

Hyperbaric oxygen systems for Category 1, Category 2, and Category 3 care connected directly to a hospital’s oxygen system shall comply withSection 5.1, as applicable, except as noted in 14.2.1.4.4.2 1 .

14.2.1.4.4.2 1 Central Supply Systems.

Oxygen systems shall comply with 5.1.3.5, as applicable, except as follows:

(1) An emergency oxygen supply connection (EOSC) is not required for the hyperbaric oxygen system.

(2) An in-building emergency reserve (IBER) is not required for the hyperbaric oxygen system.

14.2.1.4.4.3 5

Hyperbaric stand-alone oxygen systems for Category 1 and Category 2 care shall comply with Section 5.1, as applicable, except as noted in14.2.1.4.4 5 .4 1 .

14.2.1.4.4 5 .4 1 Central Supply Systems.


(1) An EOSC is not required for the hyperbaric oxygen system.

(2) An IBER is not required for the hyperbaric oxygen system.

14.2.1.4.4.5 6 Warning Systems. (A)

14.2.1.4.6.1

Oxygen systems shall comply with 5.1.9, as applicable, except that warning systems shall be permitted to be a single master/area alarm panel.

(B) 14.2.1.4.6.2

The alarm panel shall be located in the room housing the chamber(s) to allow for easy audio and visual monitoring by the chamber operator

14.2.1.4.4.6 7

Hyperbaric stand-alone oxygen systems for Category 3 care shall comply with Section 5.2, as applicable, except as noted in 14.2.1.4.4. 7. 1 .

14.2.1.4.4 7 .7 1 Central Supply Systems.


(1) If the operating oxygen supply consists of high pressure cylinders designed with a primary and secondary source, no reserve supply isrequired.

(2) If the operating oxygen supply consists of liquid containers designed with a primary and secondary source, a reserve with a minimumsupply of 15 minutes is required.

(3) If the operating oxygen supply consists of a bulk primary, a reserve with a minimum supply of 15 minutes is required.

(4) An EOSC is not required for the hyperbaric oxygen system.

(5) An IBER is not required for the hyperbaric oxygen system.


The manual of style allows for a maximum of 6 levels of paragraph numbering. Section 14.2.1.4.4 contains 5 paragraphs that are meant to be subordinate to their preceding paragraph but were not numbered as such because it would require a 7th level of numbering. The requirement in 14.2.1.4.4 is unnecessary and could be removed, allowing for renumbering of subsequent paragraphs. In the new numbering scheme, paragraphs 14.2.1.4.4.2, 14.2.1.4.4.4, 14.2.1.4.4.5(A), 14.2.1.4.4.5(B), and 14.2.1.4.4.7 are obviously subordinate to their preceding paragraphs.




Street Address:City:State:Zip:Submittal Date: Tue Jun 23 18:55:56 EDT 2015


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Public Input No. 233-NFPA 99-2015 [ Section No. 14.2.1.5 ]

14.2.1. 5 7 Storage and Handling of Medical Gases.

Storage and handling of medical gases shall meet the applicable requirements of Chapter 5.


The existing placement of this paragraph could be interpreted to apply only to oxygen systems. Moving it to the end of the section makes it more obvious that it applies to all medical gases.






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Public Input No. 446-NFPA 99-2015 [ New Section after 14.2.1.6.4.7 ]

TITLE OF NEW CONTENTType your content here ...

14.2.1.6.4.7 (3) A medical air cylinder directly connected to a Class B or Class C chamber and used to provide air to that chamber shall bepermitted to be in the same room as the chamber. The cylinder shall be considered to be "in use" and shall not be counted when determining thetotal volume of medical gas outside of a storage area in Section 11.3.


This proposed change applies to free-standing hyperbaric facilities, such as wound care centers using Class B or Class C chambers. It is typical for a chamber in such a facility to have a large H-size cylinder of medical air next to, and directly connected to, the chamber to provide "air breaks" during administration of oxygen therapy. A facility with more than one chamber together in a treatment room then has more than 300 CF of gas in the room, since one H-size cylinder contains 242 CF of gas. This requires the cylinders to be stored in a separate room and piped to each chamber, adding an unnecessary level of complexity and cost to the chamber operation.


Submitter Full Name: KOVEN SMITH

Organization: SHANDS HOSPITAL



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14.2.2.5.3

If the interior of a Class A chamber is treated (painted) with a finish described in 14.2.2.5 , the cure procedure and minimum duration for eachlayer of paint/coating to off-gas shall be in accordance with the manufacturer’s application instructions.


The existing reference to 14.2.2.5 is inaccurate. The better reference would be to 14.2.2.5.1. However, based on the flow of the requirements in section 14.2.2.5, specific reference back to the performance criteria of the paint/coating is unnecessary.


Related Input RelationshipPublic Input No. 231-NFPA 99-2015 [Section No. A.14.2.2.5] Cleaning up references within the same section.






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Public Input No. 493-NFPA 99-2015 [ Section No. 14.2.4.2.4.1 ]

14.2.4.2.4.1

The air treatment packages shall include automatic safeguards.


The requirement for automatic safeguards is unclear. The code should specify a performance parameter or objective.


Submitter Full Name: Kevin Posey

Organization: International ATMO, Inc.



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14.2. 4. 5 Emergency Depressurization and Facility Evacuation Capability.

14.2. 4. 5.1

Class A chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 6 minutes.

14.2. 4. 5.2

Class B chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 2 minutes.

14.2. 4. 5.3 *

A means for respiratory and eye protection from combustion products allowing unrestricted mobility shall be available outside a Class A or ClassB chamber for use by personnel in the event the air in the vicinity of the chamber is fouled by smoke or other combustion products.

14.2.4.5.4

The time required to evacuate all persons from a hyperbaric area with a full complement of chamber occupants all at treatment pressure shallbe measured annually during the fire training drill required by 14.3.1.4.5 .

14.2.4.5.4.1

The occupants for this training drill shall be permitted to be simulated.


The ability to evacuate the hyperbaric facility does not belong in the section on chamber ventilation. It should be promoted to its own section.The requirements for the timed evacuation drill belong under 14.3.1.4.5, which is the requirement to perform emergency procedures at least annually.


Related Input RelationshipPublic Input No. 240-NFPA 99-2015 [Sections 14.3.1.4.4, 14.3.1.4.5]




Street Address:City:State:Zip:Submittal Date: Wed Jun 24 12:01:33 EDT 2015


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14.2.4.5 Emergency Depressurization and Facility Evacuation Capability .

14.2.4.5.1

Class A chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 6 minutes.

14.2.4.5.2

Class B chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 2 minutes.

14.2.4.5.3* A means for respiratory and eye protection from combustion products allowing unrestricted mobility shall be available outside a Class A or ClassB chamber for use by personnel in the event the air in the vicinity of the chamber is fouled by smoke or other combustion products.

14.2.4.5.4

The time required to evacuate all persons from a hyperbaric area with a full complement of chamber occupants all at treatment pressure shall bemeasured annually during the fire training drill required by 14.3.1.4.5.

14.2.4.5.4.1



Move facility evacuation to Rules and regulations


Submitter Full Name: JAMES BELL

Organization: INTERMOUNTAIN HEALTHCARE



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14.2.4.5.3 *

A means for respiratory and eye protection from combustion products allowing unrestricted mobility

A breathing apparatus, with sufficient mobility, shall be available outside a

Class A or Class B

hyperbaric chamber for use by personnel in the event the air in the vicinity of the chamber is fouled by smoke or other combustion products. Itshall provide both breathing grade air and eye protection for a duration sufficient to ascend the chamber from its maximum operating pressureand evacuate all occupants and staff to a safe location. The number of breathing apparatus and their design shall be approved by theHyperbaric Safety Director.


Removes the ability to use a smoke hood with integral filter/air supply, or similar technology as a primary means of safe breathing air for staff. Adds a needed duration of operation capability requirement for the breathing apparatus.Respectfully submitted by:William Davison, CHT ([email protected])Gregory Raleigh, CHT, RCP ([email protected])


Submitter Full Name: WILLIAM DAVISON

Organization: OxyHeal Health Group

Street Address:City:State:Zip:Submittal Date: Wed Jul 01 16:46:31 EDT 2015


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14.2 3 .1. 4.5.3* A means for respiratory and eye protection from combustion products allowing unrestricted mobility shall be available outside a Class A or ClassB chamber for use by personnel in the event the air in the vicinity of the chamber is fouled by smoke or other combustion products.


Consider moving this to Rules and regulations as it is not a design feature of the chamber system


Related Input RelationshipPublic Input No. 250-NFPA 99-2015 [Section No. 14.2.4.5.4]






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14. 2 3 . 1. 4.5. 4 1

The time required to evacuate all persons from a hyperbaric area with a full complement of chamber occupants all at treatment pressure shall bemeasured annually during the fire training drill required by 14.3.1.4.5.

14. 2 3 . 1. 4.5. 4.1 2



These requirments deal with administration, moving them into 14.3. adds clarity and less flipping back and forth between the pages.






Street Address:City:State:Zip:Submittal Date: Sun Jun 28 10:41:54 EDT 2015


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Public Input No. 223-NFPA 99-2015 [ New Section after 14.2.5.3 ]

New sections to Fire Protection in Class A Chambers

14.2.5.2.9 NEW All dedicated storage vessels used to provide the deluge system with water shall be fitted with a suitable water levelindicator, with the level displayed at the chamber console.

14.2.5.2.10 NEW Deluge systems using pressurized water vessels shall be designed to prevent the driving gas supply from pressurizingthe hyperbaric chamber if all the water is driven out of the water vessel.


14.2.5.2.9 offered to ensure that the chamber operator has assurance that the deluge vessels are indeed filled with water prior to treatments commencing. Of course this does not do away with the requirements for daily visual checks nor semi-annual testing.

14.2.5.2.10 Offered to prevent excessive driving gas from adding pressure to the chamber. One solution might be a residual pressure device on the driving gas cylinder (shuts off when pressure reaches a certain minimum level, but then this would make cylinder change-out potentially restricted. Refilling is always difficult with a residual pressure device.A bladder or 'bag" which contains the water is one option, with the gas squeezing the bag, but not actually leaving the deluge vessel.


Submitter Full Name: FRANCOIS BURMAN

Organization: DIVERS ALERT NETWORK



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14.2 3 .5.5 7.x.x. * Testing.

The deluge and handline systems shall be functionally tested at least semiannually per 14.2.5.2.7 for deluge systems and 14.2.5.3.7 forhandline systems.

14.2.5.5.1

Following the test, all valves shall be placed in their baseline position.

14.2.5.5.2

If a bypass system is used, it shall not remain in the test mode after completion of the test.

14.2.5.5.3

During initial construction, or whenever changes are made to the installed deluge system that will affect the spray pattern, testing of spraycoverage to demonstrate conformance to the requirements of 14.2.5.2.6 shall be performed at surface pressure and at maximum operatingpressure.

14.2.5.5.3.1

The requirements of 14.2.5.2.6 shall be satisfied under both surface pressure and maximum operating pressure.

14.2.5.5.4

A detailed record of the test results shall be maintained and a copy sent to the hyperbaric facility safety director.

14.2.5.5.5

Inspection, testing, and maintenance of hyperbaric fire suppression systems shall be performed by a qualified person.


Create one section for all ITM requirements in our chapter


Related Input RelationshipPublic Input No. 252-NFPA 99-2015 [Section No. 14.3.6.3] fire suppression






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Public Input No. 494-NFPA 99-2015 [ New Section after 14.2.7.2 ]

A.14.2.7.2The fire alarm signaling device may be a pull station, phone, intercom, or like device.


The current wording of "fire alarm signaling device" is being read as "a pull-station" by many AHJs. An Annex note or definition in chapter 3 may resolve this issue.






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14.2.8.1.3

Console or module spaces located either outside or inside the chamber and containing both oxygen piping and electrical equipment shall beeither one of the following:

(1) Mechanically or naturally ventilated

(2) Continuously monitored for excessive oxygen concentrations whenever the electrical equipment is energized


There is no clarity whether this applies to inside or outside the chamber.






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14.2.8.1.4.1* If motors for the operation of the chamber are to be located in iniside the chamber, they shall meet the requirements of 14.2.8.3.14.


There has been confusion between motors for operation of the chamber and motors in patient care equipment. Patient care equipment is 99 chapter 10 (14.2.8.1.5, hopefully this language will help clarify.






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14.2.8.2 Electrical Service.

14.2.8.2.1

All hyperbaric facilities shall

contain an electrical service that is supplied from two independent sources of electric power.

have some means of backup electric power for the following electrically driven features:

(1) Chamber room emergency lighting

(2) Chamber emergency lighting, whether internally or externally mounted

(3) Chamber intercommunications

(4) Alarm systems, including fire detectors

(5) Chamber fire suppression system equipment and controls

(6) Electrical controls used for chamber pressurization and ventilation control

14.2.8.2.1.1

Electrical control and alarm system design shall be such that hazardous conditions (e.g., loss of chamber pressure control, delugeactivation, spurious alarms) do not occur during power interruption or during power restoration.

14.2.8.2.1. 1

All hyperbaric facilities for human occupancies shall contain an electrical service that is

2

Booster pumps in the chamber fire suppression system shall be on separate branch circuits serving no other loads.

14.2.8.2.2

Article 700 of NFPA 70, National Electrical Code, shall apply to hyperbaric systems located in facilities other than health care facilities.

14.2.8.2.3

Hyperbaric electrical service for Category 1 or 2 Care shall be supplied from two independent sources of electric power.

14.2.8.2. 1

3 .

2

1

For hyperbaric facilities using a prime-mover-driven generator set, it shall be designated as the life safety and critical branches and shall meetthe requirements of Chapter 6 for hyperbaric systems based in health care facilities.

14.2.8.2.

1.

3

Article 700 of NFPA 70 , National Electrical Code , shall apply to hyperbaric systems located in facilities other than health care facilities.

14.2.8.2.2


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14.2.8.2.3

.2

Electrical equipment associated with life-support functions of hyperbaric facilities shall be connected to the critical branch of the life safety andcritical branches, which requires that such equipment shall have electrical power restored within 10 seconds of interruption of normal power.

14.2.8.2. 2

3 .

1

The equipment specified in 14.2.8.2.2 shall include, but is not limited to, the following:

(1) Electrical power outlets located within the chamber

(2) Chamber emergency lighting, whether internally or externally mounted

(3) Chamber intercommunications

(4) Alarm systems, including fire detectors

(5) Chamber fire suppression system equipment and controls

(6) Other electrical controls used for chamber pressurization and ventilation control

(7) A sufficient number of chamber room lights (either overhead or local) to ensure continued safe operation of the facility during a normalpower outage

14.2.8.2.2.2

Booster pumps in the chamber fire suppression system shall be on separate branch circuits serving no other loads.

3

Electric motor–driven compressors and auxiliary electrical equipment normally located outside the chamber and used for chamber atmosphericcontrol shall be connected to the equipment system (see Chapter 6 ) or the life safety and critical branches (see NFPA 70 , NationalElectrical Code , Article 700) , as applicable.

14.2.8.2. 4

3.4

Electric motor–driven compressors and auxiliary electrical equipment shall be arranged for delayed-automatic or manual connection to thealternate power source so as to prevent excessive current draw on the system during restarting.

14.2.8.2.

5

3.5

When reserve air tanks or a nonelectric compressor(s) is provided to maintain ventilation airflow within the chamber and supply air for chamberpressurization, the compressor(s) and auxiliary equipment shall not be required to have an alternate source of power.

14.2.8.2.6

Electrical control and alarm system design shall be such that hazardous conditions (e.g., loss of chamber pressure control, deluge activation,spurious alarms) do not occur during power interruption or during power restoration.


Some hyperbaric facilities do not need two independent sources of electrical power. Example: a pneumatically driven monoplace chamber where ancillary critical care equipment is never used. The requirements of this section are modified to identify specific features of all hyperbaric facilities that should have back up electric power, and to allow for hyperbaric facilities with less elaborate backup power needs.


Related Input RelationshipPublic Input No. 323-NFPA 99-2015 [Section No. 14.1.3] The changes are related






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Public Input No. 408-NFPA 99-2015 [ Section No. 14.2.8.2.1 [Excluding any Sub-Sections] ]

All hyperbaric facilities shall facilities that provide Category 1 Care per 14.1.3.1 shall contain an electrical service that is supplied from twoindependent sources of electric power.


By stating which Category of Care is required to have two independent sources of electrical power we can eliminate the need for a generator at a non-emergent location. In its current state it is not uncommon for AHJs to require a generator for chambers that operator by gas pressure versus electrical power.






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14.2.8.2.1.1

All hyperbaric facilities for human occupancies shall contain an electrical service that is supplied from two independent sources of electricpower.


Paragraph 14.2.8.2.1.1 is a duplication of the superordinate paragraph immediately preceding it. It is repetitive and unnecessary.




Street Address:City:State:Zip:Submittal Date: Fri Jun 26 10:23:52 EDT 2015


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14.2.8.2.1.1

All hyperbaric facilities that provide Category 1 Care per 14.1.3.1 for human occupancies shall contain an electrical service that is supplied fromtwo independent sources of electric power.


Same substantiation as PI 408.






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Flexible cords used to connect portable utilization equipment to the fixed electrical supply circuit shall meet all of the following requirements:

(1) They shall be of a type approved for extra-hard utilization in accordance with Table 400.4 of NFPA 70 , National Electrical Code .

(2) They shall include a ground conductor * .

(3) They shall meet the requirements of 501.140 of NFPA 70 , National Electrical Code .

* Electrically-conductive casings of all portable equipment for use inside the chamber shall be grounded. Non-conductive casings forportable equipment supplied from a low voltage DC supply system do not require a ground conductor.


AC devices (110 VAC) are generally supplied with a ground conductor within the flexible electrical cord. VDC devices are generally supplied from ungrounded power supplies. Is the intention to ensure that all portable equipment for use inside the chamber should have a ground conductor?Par. 14.2.8.3.7.2 requires that "a continuous ground shall be maintained between all conductive surfaces enclosing electrical circuits and the chamber hull using approved grounding means." A VDC powered device generally does not possess any grounding facilities. Should one therefore either specify that:(1) All VAC devices shall include a ground conductor, or (2) That the electrically conductive casings of all electrical portable equipment used inside the chamber shall be grounded?

This could be addressed using the additional text marked *. We are trying to avoid adding a separate grounding wire that cannot in reality be connected to any part of the equipment housing and that will require special splicing to fit into the electrical connector (assuming we have a dedicated connector rather than a junction box inside the chamber).Grounding a VDC conductive casing will, however, prevent the accumulation of static charges.






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14.2.8.3.14 Motors.

Motors for the operation of the chamber shall meet one of the following requirements:

(1) They shall comply with 501.125(A)(1) of NFPA 70, National Electrical Code, for the chamber pressure and oxygen concentration.

(2) They shall be of the totally enclosed types meeting 501.125(A)(2) or 501.125(A)(3) of NFPA 70, National Electrical Code.


There has been confusion regarding how to apply the code for motors for chamber operation and patient care equipment

Consider removing the chamber pressure and O2 concentration language as this is not enforceable






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14.2.8.3.15.1

Lighting installed or used inside the chamber shall be rated for a pressure of 1 1 beof a type that is not damaged by exposure to pressure, 11 ⁄2 times the chamber operating pressure.


Using the word rated is problematic as there are not any lighting fixtures rated for our application






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14.2.8.3.17.1

The appliance shall be designed,constructed, inspected and constructed maintained in accordance with Chapter 10.


This helps clarify the intent of this section regarding patient care manufacture, ITM of patient care equipment.






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14.2.8.3.17.5 Battery-Operated Devices.

Battery-operated devices shall meet the following requirements:

(1) Batteries shall be fully enclosed and secured within the equipment enclosure.

(2) Batteries shall not be damaged by the maximum chamber pressure to which they are exposed.

(3) Batteries shall be of a sealed type that does not off-gas during normal use.

(4) Batteries or battery-operated equipment shall not undergo charging while located in the chamber.

(5) Batteries shall not be changed on in-chamber equipment while the chamber is in use.

(6) The equipment electrical rating shall not exceed 12 V and 48 W.

(7) Lithium and lithium ion batteries shall be prohibited in the chamber during chamber operations, unless the product has been accepted orlisted for use in hyperbaric conditions by the manufacturer or a nationally recognized testing agency.

(8)


File Name Description ApprovedFAA_airline_passengers_and_batteries.pdf

Lithium-Ion_Batteries_WP.pdf UL information regarding lithium bateries


The HEA/HYP acted correctly in prohibiting lithium and lithium ion batteries. These batteries do present a particular hazard as compared to other batteries when a fire occurs. The prohibition has allowed us time to process and investigate. Battery technology and manufacturing process has improved. It is time for a change.Consider striking the entire number 714.2.8.3.1, 14.8.3.2, 14.2.8.3.3, 14.2.8.3.4, 14.2.8.3.12 and 14.2.8.3.17 would still be in effect14.3.1.5.1.2 Would still be in effect prohibiting cell phones and personal electronic devices14.2.8.1.5 requires us to use chapter 10 for patient care equipment so these devices are part of a PM programThe existing protections in chapter 14 exceed the FAA guidelines for carry-on baggage.The provision for manufactures to approve or third party testing is not functional and does not work. The FAA and NASA have the most experience with issues related to pressure changes with these types of batteries and the FAA has developed rules for carry-on baggage and cargo. We should consider allowing a limited quantity of lithium and lithium ion batteries for essential equipment. Cells phone, and personal electronic devices would still be prohibited, temperature limits, only required equipment for chamber operation or patient care and a preventive maintenance program are all in place for the class A chamber. Our chapter 14 requirements would still be more conservative than the FAA regulations for carry on baggage.

1. Primary lithium batteries should be allowed using the same terms as any other battery in the chamber.Personal experience inside the class A chamber over the last 20 years with primary batteries (non-rechargeable) in the hands free sink, IV pumps for the memory and clock function, and vacuum regulators in hyper and hypobaric conditions with no incidents. UL abuse standard exposes the batteries to a pressure test of 2000 pounds. Clinical pressures are less than 10% of this test.2. Secondary batteries (rechargeable) should be allowed using the existing requirements. There are devices with recharge able lithium batteries that have been approved for hyperbaric chambers such as the Hyox portable defibrillator. Literature search indicates that LVAD batteries have been taken into the chamber safely. Personal communications (unpublished) with other users indicate continued use of equipment powered by rechargeable battery packs in class A chambers before and after the prohibition was added with no mishaps.Lithium ion batteries do burn explosively when crushed short circuited, overheated or damaged. These conditions are unlikely in the controlled environment of the class A chamber.The reported incidents that have occurred have been related to battery charging, large volume shipments, loose batteries shorting out, overheating caused by mixed batteries, exposure to high temperature, etc. There have been no documented cases of fires I am aware of from primary or secondary lithium or lithium ion batteries that are not charging, contained within the devise as designed, part of a required preventive maintenance program and not exposed to heat.Annex material could consider the lithium ion concern and suggest inert gas purging and temperature monitoring.Consider language allowing intrinsically safe batteriesConsider that there have been fires from other types of batteries when stored or used incorrectly.






97 of 133 7/8/2015 3:18 PM

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Batteries Carried by Airline Passengers Frequently Asked Questions

Q1. What kinds of batteries does the FAA allow in carry-on baggage (in the aircraft cabin)? A1. Passengers can carry most consumer-type batteries and portable battery-powered electronic devices for their own personal use. Spare batteries must be protected from damage and short circuit. Battery-powered devices must be protected from accidental activation and heat generation. Batteries allowed in carry-on baggage include:

Dry cell alkaline batteries: typical AA, AAA, C, D, 9-volt, button-sized cells, etc.

Dry cell rechargeable batteries such as Nickel Metal Hydride (NiMH) and Nickel Cadmium (NiCad). For rechargeable lithium-ion batteries; see next paragraph.

Lithium-ion batteries (a.k.a.: rechargeable lithium, lithium polymer, LIPO, secondary lithium). Passengers may carry all consumer-sized lithium-ion batteries (no more than 8 grams of equivalent lithium content or 100 watt hours per battery). This size covers AA, AAA, cell phone, PDA, camera, camcorder, handheld game, tablet, and standard laptop computer batteries. The watt hours (Wh) rating is marked on newer lithium ion batteries and is explained in #3 below.

Passengers can also bring two (2) larger lithium-ion batteries (more than 8 less than 25 grams of equivalent lithium content per battery or about 100-300 watt hours per battery) in their carry-on. This size covers the largest aftermarket extended-life laptop batteries and most lithium-ion batteries for professional-grade audio/visual equipment. Most lithium-ion batteries are below this size.

Lithium metal batteries (a.k.a.: non-rechargeable lithium, primary lithium). These batteries are often used with cameras and other small personal electronics. Consumer-sized batteries (up to 2 grams of lithium per battery) may be carried. This includes all the typical non-rechargeable lithium batteries used in cameras (AA, AAA, 123, CR123A, CR1, CR2, CRV3, CR22, 2CR5, etc.) as well as the flat round lithium button cells.

Nonspillable wet batteries (absorbed electrolyte), limited to 12 volts and 100 watt hours per battery. These batteries must be the absorbed electrolyte type (gel cells, AGM, etc.) that meet the requirements of 49 CFR 173.159a(d); i.e., no electrolyte will flow from a cracked battery case. Batteries must be in strong outer packagings or installed in equipment. Passengers are limited to two (2) spare (uninstalled) batteries. Spare batteries’ terminals must be protected (non-conductive caps, tape, etc.) within the outer packaging. Batteries and outer packaging must be marked “nonspillable” or “nonspillable battery.” Note: This exception is for portable electronic devices, not for vehicle batteries. There are separate exceptions for powered wheelchairs.

Q2. What kinds of batteries does the FAA allow in checked baggage? A2. Except for spare (uninstalled) lithium metal and lithium-ion batteries, all the batteries allowed in carry-on baggage are also allowed in checked baggage. The batteries must be protected from damage and short circuit or installed in a device. Battery-powered devices—particularly those with moving parts or those that could heat up—must be protected from accidental activation. Spare lithium metal and lithium ion/polymer batteries are prohibited in checked baggage.

Q3. How do I determine the watt hours (Wh) rating of a battery? A3. To determine watt hours (Wh), multiply the volts (V) by the ampere hours (Ah). Example: A 12-volt battery rated to 8 Amp hours is rated at 96 watt hours (12 x 8 = 96). For milliamp hours (mAh), multiply by the volts and divide by 1000.

Q4. Is there a limit to the number of batteries I can carry? A4. There is no limit on the number of most consumer-size batteries or battery-powered devices that a passenger can carry for personal use. The larger lithium ion batteries are limited to two (2) batteries per passenger; see “Lithium-ion batteries” explanation above. Only two (2) spare/uninstalled nonspillable wet (absorbed electrolyte) batteries may be carried.

Q5. What does “protected from short circuit” mean? A5. When metal such as keys, coins, tools or other batteries comes in contact with both terminals of a battery it can create a “circuit” or path for electricity to flow through. Electrical current flowing through this unprotected short circuit can cause extreme heat and sparks and even start a fire. To prevent short circuits, keep spare batteries in their original packaging, a battery case, or a separate pouch or pocket. Make sure loose batteries can’t move around. Placing tape over the terminals of unpackaged batteries also helps to insulate them from short circuit.

For a quick reference guide, see illustrated table on next page… Federal Aviation Administration

January 9, 2014 Office of Hazardous Materials Safety http://www.faa.gov/Go/PackSafe 54

Batteries Allowed in Airline Passenger Baggage in the US

Type of Battery There is no limit to the number of batteries or devices carried for personal use unless specified below.

Allowed in carry-on baggage?

Allowed in checked baggage?

In equipment1 Spares In equipment Spares Dry alkaline batteries

YES

YES When protected from damage and short circuit

YES


Dry rechargeable – Nickel Metal Hydride (NiMH), Nickel Cadmium (NiCad), etc.

YES


YES


Lithium ion (rechargeable lithium, lithium polymer, LIPO) as used in small consumer electronics, such as cell phones, tablets, cameras, PDAs, and laptops. Limited to 8 grams or less equivalent lithium content (100 watt hours2 or less) per battery.

YES


YES

NO

Larger lithium ion, more than 8 grams but not more than 25 grams equivalent lithium content per battery, or 100-300 watt hours2 per battery. Outside the US the limit is 160 watt hours. Limit: Two (2) batteries per passenger

YES


YES

NO

Lithium metal (non-rechargeable) as used in small consumer electronics such as cameras, LED flashlights, watches, etc. (2 grams or less lithium per battery).

YES

YES

When protected from damage and short circuit

YES

NO

Nonspillable wet batteries (absorbed electrolyte) for portable electronic devices.

YES

YES When protected from damage and short circuit and in strong packaging. Battery and outer packaging must be marked “nonspillable.”

YES

YES When protected from damage and short circuit and in strong packaging. Battery and outer packaging must be marked “nonspillable.”

For more information and for rules on battery-powered wheelchairs or assistive devices, please go to http://www.faa.gov/Go/Packsafe or call the DOT Hazardous Materials Information Center at 1-800-467-4922. For TSA security restrictions please go to http://www.tsa.gov

Limited to 12 volts and 100 watt hours2 per battery. Limit: Two (2) spare batteries per passenger.

1Note: TSA security rules prohibit some power tools in carry-on baggage. 2Note: Watt hours (Wh) = Volts (V) x Amp hours (Ah) or V x mAh ÷ 1000

Based on US DOT regulations (49 CFR, Sec. 175.10). TSA security, individual airline, and international rules may, at times, be more restrictive.

For lithium ion, see below.

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01 For more information E:: [email protected] / T:: 888.503.5536

Safety Issues for Lithium-Ion Batteries

Lithium-ion batteries are widely used as a power source in portable electrical and electronic products. While the rate of failures associated with their use is small, several well-publicized incidents related to lithium-ion batteries in actual use (including fires and explosions) have raised concerns about their overall safety. Test standards are in place that mandate a number of individual tests designed to assess specific safety risks associated with the use of lithium-ion batteries. However, Underwriters Laboratories and other standards development organizations are continuing to revise and update existing lithium battery standards to reflect new knowledge regarding lithium ion battery failures in the field. These organizations are contributing to battery safety research with a focus on internal short circuit failures in lithium ion batteries. The research is directed toward improving safety standards for lithium ion batteries.

Overview

Over the past 20 years, rechargeable (also known as secondary) lithium-ion battery technologies have evolved, providing increasingly greater energy density, greater energy per volume, longer cycle life, and improved reliability. Commercial lithium-ion batteries now power a wide range of electrical and electronic devices, including the following categories:

Consumer electrical and electronic devices• — Lithium-ion batteries power consumer electrical and electronic devices from mobile phones and digital cameras, to laptop computers.

Medical devices• — Lithium-ion batteries are also used in medical diagnostic equipment, including patient monitors, handheld surgical tools, and portable diagnostic equipment.

Industrial equipment • — Industrial equipment offers a wide range of applications for lithium-ion batteries, including cordless power tools, telecommunications systems, wireless security systems, and outdoor portable electronic equipment.

Automotive applications• — A new generation of electric vehicles is being powered by large format lithium-ion battery packs, including battery-electric vehicles, hybrid-electric vehicles, plug-in hybrid-electric vehicles, and light-electric vehicles.

WHITE PAPER ON:

1 “Lithium Batteries: Markets and Materials,” Report FCB028E, October 2009, www.bccresearch.com.

UL is involved in standards development worldwide and has technical staff

participating in leadership and expert roles on several national committees

and maintenance teams associated with battery and fuel cell technologies.

Ms. Laurie Florence is the convener (chair) of SC21A — Working Group 5.

She is a member of the SC21A US TAG & SC21A WGs 2, 3, 4, and 5. Florence

is a member of TC 35 US TAG & TC 35 MT 15 and a member of the ANSI

NEMA C18 committees. She participated in the IEEE 1625 and is participating

in IEEE 1725 revisions. Florence is also on the task group working on revising

UN T6 and participated in CTIA battery ad hoc committee.

Mr. Harry P. Jones is the convener (chair) of IEC TC105 — Working Group 8.

Florence and Jones participated in SAE J2464 and SAE J2929

standards development.

Florence and Mr. Alex Liang (UL Taiwan) and are on ETF 13 for batteries.

UL Taiwan was the first CBTL for IEC 62133, followed by UL Suzhou.

UL Japan is approved to provide PSE mark in Japan for lithium ion batteries

as part of the DENAN program.

UL is a CTIA CATL for the battery certification program.

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The worldwide market for lithium batteries is projected to reach nearly $10 billion (USD) in annual sales by 2014, with the market for lithium-ion batteries representing almost 86-percent of those sales ($8.6 billion)1. However, as the use of lithium batteries is growing globally and with the large number of batteries powering a wide range of products in a variety of usage environments, there have been several reported incidents raising safety concerns. While the overall rate of failures associated with the use of lithium-ion batteries is very low when compared with the total number of batteries in use worldwide, several publicized examples involving consumer electronics like laptop computers and electronic toys have led to numerous product safety recalls by manufacturers, the U.S. Consumer Product Safety Commission and others. Some of these cases have been linked to overheating of lithium-ion batteries, leading to possible fire or explosion.

Though global independent standards organizations, such as the International Electrotechnical Commission and Underwriters Laboratories, have developed a number of standards for electrical and safety testing intended to address a range of possible abuses of lithium-ion batteries, knowledge about potential failure modes is still growing as this complex technology continues to evolve to meet marketplace demands. Understanding and translating this knowledge into effective safety standards is the key focus of UL battery research activities and is intended to support the continual safe public usage and handling of lithium-ion batteries.

Lithium-ion battery design and selection considerations

A lithium-ion battery is an energy storage device in which lithium ions move through an electrolyte from the negative electrode (“anode”) to the positive electrode (“cathode”) during battery discharge, and from the positive electrode to the negative electrode during charging. The electrochemically active materials in lithium-ion batteries are typically a lithium metal oxide for the cathode and a lithiated carbon for the anode. The electrolytes can be liquid, gel, polymer or ceramic. For liquid electrolytes, a thin (on the order of microns) micro-porous film provides electrical isolation between the cathode and anode, while still allowing for ionic conductivity. Variations on the basic lithium chemistry also exist to address various performance and safety issues.

The widespread commercial use of lithium-ion batteries began in the 1990s. Since then, an assortment of lithium-ion designs has been developed to meet the wide array of product demands. The choice of battery in an application is usually driven by a number of considerations, including the application requirements for power and energy, the anticipated environment in which the battery-powered product will be used and battery cost. Other considerations in choosing a suitable battery may include:

Anticipated work cycle of the product (continual or intermittent) •

Battery life required by the application•

Battery’s physical characteristics (i.e., size, shape, weight, etc.)•

Maintenance and end-of-life considerations •

Lithium-ion batteries are generally more expensive than alternative battery chemistries but they offer significant advantages, such as high energy, density levels and low weight-to-volume ratios.

Causes of safety risk associated with lithium-ion batteries

Battery manufacturers and manufacturers of battery-powered products design products to deliver specified performance characteristics in a safe manner under anticipated usage conditions. As such, failure (in either performance or safety) can be caused by poor execution of a design, or an unanticipated use or abuse of a product.

Passive safeguards for single-cell batteries and active safeguards for multi-cell batteries (such as those used in electric vehicles) have been designed to mitigate or prevent some failures. However, major challenges in performance and safety still exist, including the thermal stability of active materials within the battery at high temperatures and the occurrence of internal short circuits that may lead to thermal runaway.

Photo 1: Examples of lithium-ion batteries for PCs and smart phones

2 “FTA/FMEA Safety Analysis Model for Lithium-Ion Batteries,” UL presentation at 2009 NASA Aerospace Battery Workshop.

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As part of the product development process, manufacturers should conduct a risk assessment that might involve tools such as failure modes and effects analysis and fault tree analysis. UL employs these tools to generate root cause analyses that lead to the definition of safety tests for product safety standards2.

Applicable product safety standards and testing protocols

To address some of the safety risks associated with the use of lithium-ion batteries, a number of standards and testing protocols have been developed to provide manufacturers with guidance on how to more safely construct and use lithium-ion batteries.

Product safety standards are typically developed through a consensus process, which relies on participation by representatives from regulatory bodies, manufacturers, industry groups, consumer advocacy organizations, insurance companies and other key safety stakeholders. The technical committees developing requirements for product safety standards rely less on prescriptive requirements and more on performance tests simulating reasonable situations that may cause a defective product to react.

The following standards and testing protocols are currently used to assess some of the safety aspects of primary and secondary lithium batteries:

Underwriters Laboratories UL 1642: Lithium Batteries•

UL 1973: (Proposed) Batteries for Use in Light Electric Rail •(LER) Applications and Stationary Applications

UL 2054: Household and Commercial Batteries•

UL Subject 2271: Batteries For Use in Light Electric •Vehicle Applications

UL 2575: Lithium Ion Battery Systems for Use in Electric Power •Tool and Motor Operated, Heating and Lighting Appliances

UL Subject 2580: Batteries For Use in Electric Vehicles•

Institute of Electrical and Electronics Engineers IEEE 1625: Rechargeable Batteries for Multi-Cell Mobile •Computing Devices

IEEE 1725: Rechargeable Batteries for Cellular Telephones•

National Electrical Manufacturers Association C18.2M: Part 2, Portable Rechargeable Cells and Batteries — •Safety Standard

Society of Automotive Engineers J2464: Electric and Hybrid Electric Vehicle Rechargeable •Energy Storage Systems (RESS), Safety and Abuse Testing

J2929: Electric and Hybrid Vehicle Propulsion Battery System •Safety Standard — Lithium-based Rechargeable Cells

International Electrotechnical Commission IEC 62133: Secondary Cells and Batteries Containing Alkaline •or Other Non-acid Electrolytes — Safety Requirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, for Use in Portable Applications

IEC 62281: Safety of Primary and Secondary Lithium Cells and •Batteries During Transportation

United Nations (UN)Recommendations on the Transport of Dangerous Goods, •Manual of Tests and Criteria, Part III, Section 38.3

Japanese Standards AssociationJIS C8714: Safety Tests for Portable Lithium Ion Secondary •Cells and Batteries For Use In Portable Electronic Applications

Battery Safety OrganisationBATSO 01: (Proposed) Manual for Evaluation of Energy Systems •for Light Electric Vehicle (LEV) — Secondary Lithium Batteries

Common product safety tests for lithium-ion batteries

The above standards and testing protocols incorporate a number of product safety tests designed to assess a battery’s ability to withstand certain types of abuse. Table 1 provides an overview of the various abuse tests and illustrates the extent to which safety standards and testing protocols for lithium-ion batteries have been harmonized.

It is important to note that similarly named test procedures in various documents might not be executed in a strictly identical manner. For example, there may be variations between documents regarding the number of samples required for a specific test, or the state of sample charge prior to testing.

The most common product safety tests for lithium-ion batteries are typically intended to assess specific risk from electrical, mechanical and environmental conditions. With minor exceptions, all of the above mentioned standards and testing protocols incorporate these common abuse tests. The following sections describe individual common tests in greater detail.

58


UL IEC NEMA SAE UN IEEE JIS BATSO

Test Criteria/Standard UL 1642 UL 2054 UL Subject 2271

UL Subject 2580

UL 2575 IEC 62133

IEC 62281

C18.2M, Pt2

J2464 Pt.III,S 38.3

IEEE 1625

IEEE 1725

JIS C8714

BATSO 01

External short circuit • • • • • • • • • • • • • •

Abnormal charge • • • • • • • • • • • • • •

Forced discharge • • • • • • • • • • • • •

Crush • • • • • • • • • • • •

Impact • • • • • • • • •

Shock • • • • • • • • • • • • • •

Vibration • • • • • • • • • • • • • •

Heating • • • • • • • • • • •

Temperature cycling • • • • • • • • • • • • • •

Low pressure (altitude) • • • • • • • • • • • •

Projectile • • • • • •

Drop • • • • • • •

Continuous low rate

charging

• •

Molded casing heating test •

Open circuit voltage •

Insulation resistance • •

Reverse charge • •

Penetration • • •

Internal short circuit test • • •

Safety standards and testing protocols for lithium-ion cells

Table 1: Summary of abuse tests found in international safety standards and testing protocols for lithium-ion batteries3

3 Jones, H., et al., “Critical Review of Commercial Secondary Lithium-Ion Battery Safety Standards,” UL presentation at 4th IAASS Conference, Making Safety Matter, May 2010.

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Electrical testsExternal short circuit test • — The external short circuit test creates a direct connection between the anode and cathode terminals of a cell to determine its ability to withstand a maximum current flow condition without causing an explosion or fire.

Abnormal charging test • — The abnormal charging test applies an over-charging current rate and charging time to determine whether a sample cell can withstand the condition without causing an explosion or fire.

Forced discharge test • — The forced discharge test determines a battery’s behavior when a discharged cell is connected in series with a specified number of charged cells of the same type. The goal is to create an imbalanced series connected pack, which is then short-circuited. To pass this test, no cell may explode or catch fire. (This test is not required under BATSO 01.)

Mechanical testsCrush test• — The crush test determines a cell’s ability to withstand a specified crushing force (typically 12 kN) applied by two flat plates (typically although some crush methods such as SAE J2464 include a steel rod crush for cells and ribbed platen for batteries). To pass this test, a cell may not explode or ignite. (This test is not required under IEC 62281 or UN 38.3.)

Impact test • — The impact test determines a cell’s ability to withstand a specified impact applied to a cylindrical steel rod placed across the cell under test. To pass this test, a cell may not explode or ignite. (This test is not required under SAE J2464, JIS C8714, or BATSO 01.)

Shock test • — The shock test is conducted by securing a cell under test to a testing machine that has been calibrated to apply a specified average and peak acceleration for the specified duration of the test. To pass this test, a cell may not explode, ignite, leak or vent.

Vibration test • — The vibration test applies a simple harmonic motion at specified amplitude, with variable frequency and time to each cell sample. To pass this test, the cell may not explode, ignite, leak or vent.

Environmental testsHeating test• — The heating test evaluates a cell’s ability to withstand a specified application of an elevated temperature for a period of time. To pass this test, the cell may not explode or ignite. (This test is not required under IEC 62281, UN 38.3 or BATSO 01.)

Temperature cycling test • — The temperature cycling test subjects each cell sample to specified temperature ranges above and below room temperature for a specified number of cycles. To pass this test, the cell may not explode, ignite, vent or leak.

Low pressure (altitude) test• — The low-pressure test evaluates a cell sample for its ability to withstand exposure to less than standard atmospheric pressure (such that in an aircraft cabin that experiences sudden loss of pressure). To pass this test, the cell may not explode, ignite, vent or leak. (This test is not required under UL 2054.)

Photo 2: Lithium-ion batteries under test

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Additional specialized tests

In addition to the common abuse tests discussed above, certain product safety standards and testing protocols for lithium-ion batteries require additional specialized testing. These specialized tests address specific uses and conditions in which the batteries might be expected to operate.

Projectile (fire) test• — The projectile test is required under UL 1642. UL 2054, UL Subject 2271, IEEE 1625 and IEEE 1725. The test subjects a cell sample to a flame from a test burner, while positioned within a specified enclosure composed of wire mesh and structural support. If the application of the flame results in an explosion or ignition of the cell, no part of the cell sample may penetrate or protrude through the wire mesh enclosure.

Drop test• — The drop test is required under UL Subject 2271, UL Subject 2580, IEC 62133, IEC 62281, NEMA C18.2M Part 2, JIS C8714 and BATSO 01. The test subjects each cell or battery sample to a specified number of free falls to a hard surface. The cell sample is examined after a time following each drop. To pass this test, the cell may not explode or ignite.

Continuous Low Rate Charging Test • — The continuous low rate charging test is required under IEC 62133. This test subjects fully-charged cell samples to a long-term, uninterrupted charge at a rate specified by a manufacturer. To pass this test, the cell may not explode, ignite, vent or leak.

Mold stress test • — The molded casing-heating test is required under NEMA C18.2M Part 2, UL 2054, IEC 62133 and UL Subject 2271. The test exposes plastic-encased batteries to a specified elevated temperature and for a specified time. Once the battery has cooled to room temperature the cell is examined. To pass this test, the internal cells may not show any evidence of mechanical damage.

Insulation resistance test • — The insulation resistance test is required under UL Subject 2580, IEC 62133 and NEMA C18.2M Part 2 (conducted as a pretest condition only). The test subjects a cell sample to a resistance measurement between each battery terminal and the accessible metal parts of a battery pack. To pass this test, the measured resistance must exceed the specified minimum value.

Reverse charge test • — The reverse charge test is required under IEC 62133, UL Subject 2271 and UL Subject 2580. This test determines a discharged cell sample’s response to a specified charging current applied in a reverse polarity condition for a defined period of time. To pass this test, the cell may not explode or ignite.

Penetration test • — The penetration test is required under UL Subject 2271, UL Subject 2580 and SAE J2464. The test uses a pointed metal rod to penetrate a cell and simultaneously measures rod acceleration, cell deformation, cell temperature, cell terminal voltage and resistance.

Internal short circuits: potential causes and testing issues

A review of lithium-ion battery safety research shows a strong focus on internal short circuits. Some field failures resulting in fires or explosions, leading to product damage or personnel injury, have been linked to an internal short circuit within the lithium-ion battery. However, as shown in Table 1, most lithium-ion battery safety standards and testing protocols do not specifically include testing for internal short circuits. In recent years, UL has partnered with key battery research facilities such as Argonne National Laboratories and the National Aeronautic and Space Administration to better understand the root causes of internal short circuits. The focus of our research has been on defining and developing safety tests that assess the propensity of a battery to experience a short circuit under certain abuse conditions.

Potential causes of internal short circuits

Although an internal short circuit may have many causes, it is basically a pathway between the cathode and anode that allows for efficient but unintended charge flow. This highly localized charge flow results in joule heating due to internal resistance, with subsequent heating of the active materials within the lithium-ion battery. The increased heat may destabilize the active materials, in turn starting a self-sustaining exothermic reaction. The subsequent heat and pressure build-up within the cell may lead to catastrophic structural failure of the battery casing and the risk of additional combustion as a result of exposure to outside air.

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For more information E:: [email protected] / T:: 888.503.553607Copyright © 2010 Underwriters Laboratories Inc. All rights reserved. No part of this document may be copied or distributed without the prior written consent of Underwriters Laboratories Inc.10/09 BDI 100807.4

Lithium-ion batteries are designed with integrated safety devices that open the external electrical load in the event of an over-current condition or relieve excessive pressure build-up in the cell. However, these safety devices are unable to mitigate all internal cell fault situations, such as an internal short circuit. For products like electric vehicles, the presence of hundreds of these batteries requires more sophisticated safeguards such as battery management systems. Clearly, the desired goal is a test portfolio (simulating a wide variety of abuse conditions) that can assess the likelihood of a battery to manifest a short circuit.

However, in designing a test for a specific failure, the root causes and failure pathways must be known. These causes may include a large internal defect or a severe external force that deforms the inner layers of the battery sufficiently to compromise the separator. In many failure incidents, only partial root-cause and failure information is available. Lithium-ion battery designers and researchers are working to create new battery designs that mitigate the impact of these causes.

Internal short circuit tests

The variety of root causes for internal short circuits makes it difficult to design a single safety test that can assess the robustness of a lithium-ion battery. To date, only JIS C8714 specifies an internal short circuit test, known as the forced internal short circuit (FISC) test. (Note that IEEE 1625, Annex D references the FISC test found in JIS C8714.) This test creates an internal short circuit by disassembling a charged cell sample casing and placing a specified nickel particle under the cell winding construction. (This is an inherently dangerous process for the test operator.) The cell sample, minus the casing, is then subjected to a specified crushing action at an elevated temperature. However, best practice in safety test design precludes disassembly of a product. All tests should be designed for execution with minimum risk to laboratory personnel4.

To that end, UL researchers have developed a test5 that induces internal short circuits by subjecting lithium-ion battery cells to a localized indentation under elevated temperature conditions. During this test, the open circuit voltage, cell surface temperature force and position of the indenter probe are measured in real time. The test is currently under development for possible inclusion in UL 1642 and UL Subject 2580.

Moving from battery to system safety

Lithium-ion batteries are typically marketed and sold directly to original equipment manufacturers (OEMs) as components to be integrated into end-use products. Because the OEM’s product actually controls these functions, product safety issues involving cell charging rates, discharging rates and reverse charging may not be adequately addressed by battery testing alone.

In such cases, international standards organizations are working to improve OEM product compatibility with integrated lithium-ion batteries by including appropriate performance testing in applicable standards. An example of such an approach to performance testing can be found in IEC 60950-1 (UL 60950-1), Information Technology Equipment — Safety — Part 1.

Looking ahead

As the development of lithium-ion batteries is an active area in fundamental research and product development, knowledge regarding the use and abuse of these products and their possible failure modes is still growing. Therefore, it is important that safety standards continue to evolve to help drive toward the safe commercial use of these energy storage devices as they power more and more products. UL will continue dedicating significant resources to translating battery safety research into safety standards. This focus will cover the wide range of chemistries and battery designs. The work includes the multi-scale continuum, from material and component-level characterization to battery systems and beyond.

For additional information about this white paper, please contact Ms. Laurie Florence, Primary Designated Engineer — Batteries, Capacitors, Fuel Cells and H2 Generators, at [email protected].

4 Yen, K.H., et al., “Estimation of Explosive Pressure for Abused Lithium-Ion Cells,” UL presentation at 44th Power Sources Conference, July 2010.

5 Wu, Alvin, et al., “Blunt Nail Crush Internal Short Circuit Lithium-Ion Cell Test Method,” UL presentation at NASA Aerospace Battery Workshop, 2009.

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14.2.8.3.17.5 Battery-Operated Devices.

Battery-operated devices shall meet the following requirements:(a) Batteries shall be fully enclosed and secured within the equipment enclosure.

(b) Batteries shall not be damaged by the maximum chamber pressure to which they are exposed.

(c) Batteries shall be of a sealed type that does not off-gas during normal use.

(d) Batteries or battery-operated equipment shall not undergo charging while located in the chamber.

(e) Batteries shall not be changed on in-chamber equipment while the chamber is in use.

(f) The equipment electrical rating shall not exceed 12 V and 48 W.

(g) The use of Lithium and lithium ion batteries shall be prohibited in the chamber during chamber operations, unless the product has beenaccepted or listed for use in hyperbaric conditions by the manufacturer

or, a nationally recognized testing agency , or has been subjected to a risk analysis conducted by a qualified person and approved by the SafetyDirector, or the manufacturer .


File Name Description ApprovedPC_26_HYP.pdf NFPA 99_PC26


NOTE: The following Public Input appeared as “Reject but Hold” in Public Comment No. 26 of the (A2014) Second Draft Report for NFPA 99 and per the Regs. At 4.4.8.3.1.The committee, in my opinion, acted correctly prohibiting Lithium ion batteries in the chamber. There is currently no test of pressure applied to these types of batteries and the risk of fire from a failure of the battery is higher than a similar sized battery.The technology surrounding Lithium Ion batteries is changing rapidly. There does not seem to be any standard test we could apply to batteries that would insure safety. To "just say no" does not seem appropriate either. It is a matter of energy density or potential, pressure the battery is exposed to, type of battery and proximity to an atmosphere of increased oxygen partial pressure. A hearing aid battery inside brass housing for hands free sink tap operation is much different to a hearing aid battery inside an ear in an Oxygen hood or a large rechargeable battery pack. As technology changes so will the risk. We need flexibility now and in the future and risk mitigation is an auditable way forward.



Organization: NFPA

Street Address:City:State:Zip:Submittal Date: Thu Apr 09 14:28:49 EDT 2015


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Inert Gas Purging of Electrical Devices14.2.8.3.18 Inert Gas Purging

14.2.8.3.18.1*

Unless specifically cleared by the manufacturer for HBO use, or declared safe for use in an oxygen enriched environment, all AC and DCequipment used inside the chamber shall be inert gas purged. Exceptions would include small low voltage battery powered devices with no morethan two (2) 1.5 VDC batteries and the device is not rechargeable. Note: Additional safe practice guidelines for inert gas purging are listed inAnnex B under B14.2.8.3.17.7 Inert Gas Purging.

14.2.8.3.18.2*

Where inert gas purging is used, the following shall apply.

(1) Each electrical device shall comply with section 14.2.8.3.19.

(2) Each inert gas purged device shall have its own dedicated purging line and flowmeter with each flowmeter clearly labled with the commonCGA inert gas name.

(3) Oxygen percent shall be maintained at less than or equal to 6 percent within the electrical compartment(s) of the device at all treatmentlevels.

(4) The manufacturer's safe operating temperature range shall be maintained at all treatment levels.

(5) Supply pressure for inert gas purging shall be supplied from a regulator system that will maintain the surface pressure over the chamber'streatment pressure, or over-bottom pressure.

(6) An audio and visual alarm system shall activate at the operator's console if there is a loss of sufficient pressure to maintain set flowrates tothe inert gas purging system during any pressurization of the chamber.

(7) Chamber operations shall be aborted if there is a loss of sufficient pressure to the inert gas purging system as noted in (6).

(8) Oxygen monitoring of the chamber's atmosphere shall have a low level alarm limit set at no lower than 18 percent.

(9) Electrical devices that are enclosed, such as TV monitors placed in acrylic boxes, shall have some means of extinguishing the device withwater from the deluge system or the hand held hose.

(10) Chambers with inert gas purging systems shall keep the chamber doors open during non-operational hours.


Currently chapter 14 has only one mention of inert gas purging with no minimal requirements or guidelines listed in chapter 14 or the Annexes. This additional section is an attempt to introduce some minimal requirements and further safe practice guidelines in Annex B. The standard for allowable oxygen percentage in a purged device is stated in the notes of Annex B Table B.14.4 "Pressure Table" stating that "However, 6 percent oxygen in nitrogen will not support combustion, regardless of oxygen partial pressure".

Introducing an electrical device inside a chamber increases the risk of fire as stated in 14.2.8.3*. This is true even if the device is less than 120 VAC and under 2 amps. I would petition that this risk also applies to DC devices as well as all corded and cordless devices except as mentioned in 14.2.8.3.18.1.


Related Input RelationshipPublic Input No. 345-NFPA 99-2015 [Section No. 14.2.8.3.17.6]

Public Input No. 347-NFPA 99-2015 [New Section after A.14.2.8.3.17]

Public Input No. 454-NFPA 99-2015 [New Section after 14.2.8.3.17.6]


Submitter Full Name: WILLIAM GOSSETT

Organization: CONVERGENT, LLC



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Evaluation of Electrical Devices14.2.8.3.19 Evaluation of Electrical Devices

14.2.8.3.19.1

This section applies to all electrical devices used in a Class A chamber except as noted in 14.2.8.3.18.1

14.2.8.3.19.2

A risk assessment process shall be established with proper documentation and signatures for all electrical devices approved for use in a Class Achamber. Reference material for the risk assessment process can be found in Annex D.2.3.1

14.2.8.3.19.3

For electrical devices receiving a risk assessment the following shall apply.

(1) The safety director, working under the medical director, shall oversee and approve of developing the proper documentation for the riskassessment process.

(2) An approved risk assessment process shall be established and signed by the medical director, safety director, unit manager and by at leastone administrative or organizational representative.

(3) The risk assessment process shall be reviewed and approved annually by the medical director, safety director, unit manager and by at leastone administrative or organizational representative.

(4) The risk assessment process shall comply with all applicable codes of this chapter.

(5) Documentation of any risk assessment that grants approval for an electrical device to be used inside the chamber shall be signed and datedby the medical director, safety director, unit manager and a representative of each party involved with the risk assessment.

(6) Policies and procedures shall be written in such a way to ensure that all mitigation orders from the risk assessment are carried out when theapproved device is used inside the chamber.

(7) The medical director, safety director and unit manager shall approve, review and sign these policies and procedures annually.

(8) Changes or modifications to the risk assessment process shall be signed as medical director, safety director, unit manager and by at leastone administrative or organizational representative.

(9) Changes or modifications to the policies or procedures shall be signed by the medical director, safety director and unit manager.

(10) The medical director, safety director, unit manager and at least one administrator or organizational representative can appoint a qualifiedperson(s) to assist the safety director in this process.


This section is added to underscore the importance of risk assessment and require some type of an approved and established process. There may be a temptation to think that by applying an inert gas purge to an electrical device this is all that is needed to introduce it into the chamber.

This section is also added to share the burden of responsibility and underscore the importance of this process to all responsible parties.

The last item (10) is added because the designated safety director may not have the level of education, training and or experience needed to oversee the requirements of this section.


Related Input RelationshipPublic Input No. 346-NFPA 99-2015 [New Section after 14.2.8.3.17.6]






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14.2.8.3.17.6 Cord-Connected Devices.

Cord-connected devices shall meet the following requirements:

(1) All portable, cord-connected equipment shall have an on/off power switch.

(2) The

equipment electrical rating shall not exceed 120 V and 2 A, unless the electrical portions of the equipment are inert-gas purged.

(3) The plug of cord-connected devices shall not be used to interrupt power to the device.


The additional section for inert gas purging will cover this deletion.








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14.2.8.4 Grounding and Ground-Fault Protection.

14.2.8.4.1

All chamber hulls shall be grounded to an electrical ground or grounding system that meets the requirements of Article 250, Grounding andBonding, Section III, Grounding Electrode System and Grounding Electrode Conductor, of NFPA 70, National Electrical Code.

14.2.8.4.1.1

Grounding conductors shall be secured as required by Article 250, Grounding and Bonding, Section III, Grounding Electrode System andGrounding Electrode Conductor, of NFPA 70, National Electrical Code.

14.2.8.4.1.2

The material, size, and installation of the grounding conductor shall meet the requirements of Article 250, Grounding and Bonding, Section VI,Equipment Grounding and Equipment Grounding Conductors, of NFPA 70, National Electrical Code, for equipment grounding conductors.

14.2.8.4.1.3

The resistance between the grounded chamber hull and the electrical ground shall not exceed 1 ohm.

14.2.8.4. 1.5

The resistance shall be veriifed and documented as in 14.3.4 Inspection, Testing and Maintenance

14. 2.8.4.2

In health care facilities, electrical power circuits located within the chamber shall be supplied from an ungrounded electrical system equippedwith a line isolation monitor with signal lamps and audible alarms.

14.2.8.4.2.1

The circuits specified in 14.2.8.4.2 shall meet the requirements of 517.160(A) and 517.160(B) of NFPA 70, National Electrical Code.

14.2.8.4.2.2

Branch circuits shall not exceed 125 V or 15 A.

14.2.8.4.3

Wiring located both inside and outside the chamber, that serves line level circuits and equipment located inside the chamber, shall meet thegrounding and bonding requirements of 501.30 of NFPA 70, National Electrical Code.


Add language for documentation of chamber ground in new ITM section. UHMS accreditation surveys I have been on, there are facilities that do not know if the chamber is grounded as they do not test on a regular basis.






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In health care facilities, V AC electrical power circuits located within the chamber shall be supplied from an ungrounded electrical system

equipped with a line isolation monitor with signal lamps and audible alarms.


A line isolation monitor does not generally monitor any actual current flow, but rather it predicts what could flow should there be a low-impedance connection from either L1 or L2 to ground. These monitors are used with VAC powered systems and generally not VDC powered systems. This is confusing and reads as if ALL electrical power circuits located in the chamber shall utilise a line isolation monitor. The inserted term VAC could help clarify this.






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In health care facilities, electrical Electrical power circuits located within the chamber shall be supplied from an ungrounded electrical systemequipped with a line isolation monitor with signal lamps and audible alarms.


The term "In Healthcare Facilities" should be removed because this code should be applied regardless of occupancy.






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Public Input No. 227-NFPA 99-2015 [ New Section after 14.2.8.4.3 ]

Ground-Fault Circuit Interrupter14.2.8.4.4 A Ground-Fault Circuit Interrupter (GFCI) shall be installed on each separate, grounded V AC power supply system used for

equipment located outside the chamber. .


There is no real provision for a specified requirement on Ground-Fault Protection for grounded power supplies used outside the chamber, other than as the title in 14.2.8.4 suggests. Annex A.3.3.63 contains suitable wording for the installation of a Ground Gault Circuit Interrupter (GFCI). Our chambers are grounded to earth and are significant metallic constructions. Consider the inclusion of the requirement, which includes the updated information in UL 943 (due to be effected in July 2015).

Then, to be added to Annex A if not included here……..UL 943 Class A requires a trip threshold current (I) of 6 mA and a response time (t) according to the inverse time-current curve, t ≤ (20/I)1.43. UL 943 Class C requirements may be considered where both grounding and double-isolation transformers are employed, with a trip threshold current increased to 20 mA. Reaction times remain as per the existing inverse time-current curve.

Question: Should we not express a preference in the Annex for the use of DC only, and to avoid using AC power inside the chamber?

In summary, concerning grounded and ungrounded power:

(1) VAC outside the chamber: grounded power connected to individual GFCI's so that the fault on one device does not render other devices inoperable.(2) VAC inside the chamber: supplied from an isolated power supply (IPS) and fitted with a line isolation monitor (LIM). The LIM and the chamber need to be grounded, of course. No GFCI is connected to the internal parts of the chamber power supply systems.(3) VDC inside the chamber: supplied through a suitably isolated (i.e. with an electrostatic shield between the primary and secondary windings), step-down transformer. VDC inside the chamber is not monitored by a LIM; however, it should have suitable current overload safety devices (trip switches, breakers or fuses) located outside the chamber.






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Electrical equipment inside Class B chambers shall be restricted to communications functions and , patient physiological monitoring leads andpatient care equipment specifically designed, tested and approved for clinical hyperbaric conditions .


File Name Description ApprovedSiaretron_literature_WC.pdf

Siaretron_Manual_2014.pdf


There is a critical lack of equipment available for patient care with hyperbaric chambers. The change in language will allow for equipment that is specifically designed, approved by the manufacturer and tested for clinical hyperbaric conditions.

The attached ventilator is an example of equipment that has been approved and in use inside class A and B chambers in Europe. FDA 501K approval is pending in the USA.

To the point, a common tool used in class B chambers is the TcpO2 electrode, while it has been tested by the manufacturer for and used in chambers for many years, the existing language does not allow it and the FDA 510K does not list hyperbaric use as one of the environmental conditions. The TcpO2 electrode is a diagnostic tool and is not used for vital signs such as BP, pulse rate etc...I suggest many of us have called the TcpO2 electrode a physiological monitoring device and suspect this is an area left to interpretation.

We need to allow language in the code for current use and future changes in technology.






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Siaretron 1000 IPER

Lung ventilator

for hyperbaric chamber

User manual

77

Siaretron 1000 IPER III

GENERAL INFORMATION The information contained in this manual are the exclusive property of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. and may not be reproduced in any way without authorisation. SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. reserves the right to modify or replace this manual at any time without prior notice.

It is however recommended that you make sure you have the most recent version of the manual. In the event of doubt, contact SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. (see the address on page IX). The information contained in the present User’s Manual can be considered correct, but do not exclude professional knowledge by the user.

The operation and maintenance of Siaretron 1000 IPER lung ventilator for hyperbaric chamber must be entrusted to qualified technical personnel only. The responsibility of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. concerning the Siaretron 1000 IPER lung ventilator and its use is limited to what is indicated in the guarantee supplied.

The contents of this manual do not in any way limit the right of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. to revise, change or modify without prior notice the equipment (including the relative software) described herein.

Unless otherwise specifically agreed in writing, SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. is not obliged to supply such revisions, changes or modifications to the owner or user of the equipment (including the relative software) described herein.

The information contained in this manual refers to the versions of Siaretron 1000 IPER lung ventilator produced or updated after September 2014. It is possible that some information may not apply to previous versions. Contact SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. if you have any doubts.

User’s Manual, version DU3069100

Revision - 02.09.2014

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IV User manual, DU3069100 / rev. - 02.09.2014

Observations

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. wishes to thank you for purchasing one of its products.

Any comment on the accuracy and usefulness of this User’s Manual would be very helpful in allowing us to guarantee current and future users of the high quality level of our manuals. We would be grateful if you would send us your comments (see address at page IX).

The SIARE trademark is used throughout this manual as an abbreviation for the manufacturer: SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.

Directive 93/42 EEC

Definitions

Three symbols are used in this User’s Manual to indicate particularly important information.

WARNING!

This indicates a condition of danger for the patient or for the operator.

CAUTION

This indicates the possibility of danger to the ventilator.

NOTE

This indicates information worthy of note, making the operation of the Siaretron 1000 IPER lung ventilator more efficient or practical.

80

Siaretron 1000 IPER V

Warnings, cautions and notes

You are advised to carefully read the information given alongside the three symbols shown on the previous page, since it contains considerations on the safety, the special requirements for the use Siaretron 1000 IPER lung ventilator (hereinafter called ventilator) and the relative safety regulations.

In order to understand how the ventilator works and how to use it correctly to ensure patient and user safety, the recommendations and instructions contained in this manual must be read with care and understood.

In order to grant maximum reliability and to ensure the patient and operator’s safety, the ventilator was designed and manufactured following warranty standards of quality of the product and its components. Any part of circuit must therefore only be replaced with original spare parts supplied or checked by SIARE.

The ventilator must only be used for the purposes specified herein and the safety of the ventilator is therefore only guaranteed if it is used in accordance with the instructions given in this manual.

The ventilator must only be used by qualified personnel and only in equipped and dedicated rooms, according to the regulations in force in the country where the ventilator is installed. Furthermore, during all the operation of ventilator, it is required the presence of qualified personnel.

Regarding the general safety and to ensure correct technical assistance and avoid possible physical damage to the patient, the maintenance schedule foreseen in this manual must be respected; qualified personnel must only carry out maintenance of the ventilator or authorised modifications to the ventilator. The user of this product is solely responsible for any operating defect caused by improper use or interventions carried out by third parties other than specialised SIARE personnel.

The maintenance and the replacement of any part have to be performed by authorized service personnel and only original SIARE spare parts or components checked by SIARE should be used.

Regarding the general safety of the electro-medical equipment, it is important to follow all rules about the interaction between the machine and the patient, the operator and the nearby environment.

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For any repairs to ventilator (due to malfunctioning, defects or failures), the user must contact SIARE or the authorised local Technical Service Centre; it is advisable to specify the data on the identification label (model, serial number, ……) when requesting intervention.

SIARE recommends establishing a maintenance and service contract with SIARE or the local authorised service dealer in order to guarantee the scheduled maintenance required to operate the ventilator in a safe and correct manner.

To prevent the risk of fire, keep the ventilator and/or the oxygen tubes away from matches, lit cigarettes and inflammable material, such as anaesthetic gases and/or sources of heat.

Do not connect the ventilator to the patient by flexible connectors, and antistatic or conductive tubes to prevent patient burnings during the use of high frequency surgical equipment, specially dangerous with antistatic tubes. The use of flexible connectors, antistatic or conductive tube is never permitted with ventilator.

Do not use worn and consumed tubes or tubes contaminated by flammable substances like grease or oil to deliver oxygen; (fabrics, oil and other fuels can easy ignite and they intensively burn in air with high concentration of oxygen.

In the event of fire or an unpleasant smell (e.g. a smell of burning), the ventilator should immediately be disconnected from the electrical power supply and from the battery (if fitted).

When coming into contact with any component of the ventilator, the hospital procedures for the handling of infected material should always be respected.

SIARE is aware that cleaning, sterilisation and disinfection procedures vary considerably from one health structure to another. SIARE cannot be held responsible for the efficacy of the cleaning and sterilisation procedures, nor for the other procedures carried out while the patient is being treated. As regards cleaning, sterilisation and disinfection of the product components, it is therefore recommended that the regulations currently in force in the country where the ventilator is installed be taken into consideration.

The ventilator was not designed as a total monitoring device: some conditions of danger for the patients treated with vital support equipment will not trigger any alarm.

Before using the ventilator or any connected component, carefully check that the ventilator is functioning correctly; when needed, the preliminary tests must be performed as described in the present manual.

82

Siaretron 1000 IPER VII

Do not use pointed instruments, such as pencils, screwdrivers or the like to make selections or settings as they could damage the surface of the LCD panel.

Check the ventilator periodically as described in the relative “Maintenance” chapter and do not use it if it is faulty or malfunctioning. Replace any broken, missing, obviously worn, deformed or contaminated parts immediately, with spare parts supplied by SIARE.

Do not connect external devices NOT manufactured or NOT authorized by SIARE to the ventilator (example: scavenging systems, patient simulators, etc…..), and not described in the present user’s manual: in case of need contact SIARE.

The correct functioning of the ventilator can be impaired if original SIARE spare parts and accessories are not used; the use of other accessories is however allowed only if formally authorised by SIARE in accordance with current safety regulations.

SIARE assumes all foreseen legal liability if the ventilator is used and periodically maintained according to the instructions contained in this manual: the Technical Assistance Report, drawn up and signed by the authorised SIARE technician, is proof of the completion of the scheduled maintenance.

Notwithstanding the ventilator is equipped with a safety valve which allows to the patient to breathe spontaneously the ambient air even in case of gas supply failure, the auxiliary ventilation system must be always promptly available; such a component is part of SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. products range.

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VIII User manual, DU3069100 / rev. - 02.09.2014

WARNING !!

The ventilator is not approved for operation in places where there is any risk of explosion.

Do not use the ventilator in the presence of flammable gases.

WARNING !!

The ventilator must not be used with an oxygen concentration inside the chamber which is over 25%.

The ventilator cannot be used in the presence of explosive gases.

WARNING !!

Before starting the ventilator use, you have to carry out the preliminary checks.

WARNING !!

Before connecting the ventilator to other electrical equipment not described in this manual, a request for authorisation should be sent to Siare.

WARNING !!

Qualified staff must make the regulation of ventilation parameters.

WARNING !!

An auxiliary ventilation system is suggested for the patients for which the ventilator represents a life support.

WARNING !!

Means for independent ventilation shall be available (i.e. manual resuscitation bag with mask) whenever the ventilator is in use.

84

Siaretron 1000 IPER IX

SIARE declines all civil and penal responsibility in the following cases:

If the ventilator is used in conditions and for purposes not stated or described in this manual.

If the ventilator is used by non-qualified personnel.

If periodic maintenance as foreseen by this manual has not been carried out correctly or has been skipped.

If personnel not officially authorised by SIARE have performed maintenance.

If non-original SIARE spare parts or components not checked by SIARE have been used.

If the ventilator has been connected to equipment not complying with the safety norms for the intended use.

Direct or indirect damage to persons or things caused by unauthorised technical intervention or by improper use of the ventilator not in accordance with the instructions contained in the users and maintenance manual.

Year of manufacture

Check the identification data label of the ventilator in the relative chapter.

Manufacturer

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore, 18 - 40056

Località Crespellano, 40053 Valsamoggia (BO), ITALY

Tel.: +39 051 969802 - Fax: +39 051 969366

E-mail: [email protected] - web: www.siare.it

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X User manual, DU3069100 / rev. - 02.09.2014

Electromagnetic Compatibility

The Siaretron 1000 IPER lung ventilator is designed to operate in the specified electromagnetic environment (see warning below).

The customer or the user of Siaretron 1000 IPER lung ventilator should ensure that it is used in such an electromagnetic environment.

The ventilator complies with the EN 60601-1-2 regulations on Electromagnetic Compatibility of electro-medical equipment. It is in any case highly recommended not to use the ventilator adjacent to high-powered equipment or to units, which emit strong electro-magnetic fields. Mobile phones, cordless phones or other radio transmitters used in the vicinity of the ventilator could influence its operation. Whenever the ventilator should be necessarily used nearby to such equipment, it will be required to supervise its normal operation.

In general, as regards the regulations regarding “electromagnetic emissions”, “electromagnetic immunity” and “recommended separation distances between portable and mobile RF equipment and the device”, always refer to what is described in the ventilator manual.

Requirements applicable to cables, transducers and other accessories that could affect compliance with the requirements of 6.1 and 6.2

86

Siaretron 1000 IPER XI

Table of contents

GENERAL INFORMATION ................................................................................................III Observations................................................................................................................................... IV

Definitions ....................................................................................................................................... IV

Warnings, cautions and notes..........................................................................................................V

Year of manufacture ....................................................................................................................... IX

Manufacturer ................................................................................................................................... IX

Electromagnetic Compatibility..........................................................................................................X

Table of contents ............................................................................................................................XI

1 INTRODUCTION ...................................................................................................... 1-1 1.1 Foreseen use...................................................................................................................... 1-1

1.2 Main innovations................................................................................................................. 1-2 1.2.1 Matchless performance up to a depth of 60 mH2O................................................................1-2 1.2.2 Automatic compensation of all ventilation parameters ...........................................................1-2 1.2.3 High performance intensive care ventilator ............................................................................1-2 1.2.4 Peep and flow by leakages compensation .............................................................................1-2 1.2.5 9” TFT led display, five graphs displayed simultaneously ......................................................1-3 1.2.6 Compatible with premixed Heliox ...........................................................................................1-3 1.2.7 External remote control panel to facilitate the therapy inside mono-place chambers.............1-3 1.2.8 Small dimensions and light weight .........................................................................................1-3 1.2.9 Special hermetic battery.........................................................................................................1-3

1.3 Correct operation ................................................................................................................ 1-4 1.3.1 Use of Siaretron 1000 IPER...................................................................................................1-5

1.4 Applicable norms ................................................................................................................ 1-6

2 DESCRIPTION ......................................................................................................... 2-1 2.1 Gas supply side .................................................................................................................. 2-3

2.2 Power supply area .............................................................................................................. 2-4

2.3 Patient connections ............................................................................................................ 2-5

2.4 Keyboard with soft key and encoder knob.......................................................................... 2-6 2.4.1 Encoder knob : use ................................................................................................................2-6 2.4.2 Soft keys: use.........................................................................................................................2-8

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2.5 9” LED display .................................................................................................................... 2-9 2.5.1 Operative functions and graphic setting .................................................................................2-9 2.5.2 Respiratory parameters monitoring ......................................................................................2-12 2.5.3 Operative mode selection.....................................................................................................2-15 2.5.4 Alarm signals area ...............................................................................................................2-17 2.5.5 Graphic area ........................................................................................................................2-18 2.5.6 Graphic view : lungs icon .....................................................................................................2-20 2.5.7 Additional respiratory parameters ........................................................................................2-21 2.5.8 General informations ............................................................................................................2-23

2.6 MAIN MENU ..................................................................................................................... 2-24

3 PREPARATION FOR USE....................................................................................... 3-1 3.1 General warnings................................................................................................................ 3-1

3.2 Before use .......................................................................................................................... 3-3 3.2.1 Mounting the O2 sensor .........................................................................................................3-3 3.2.2 Battery Recharge ...................................................................................................................3-4

3.3 Preparation for use ............................................................................................................. 3-6 3.3.1 Connection to power supply ...................................................................................................3-6 3.3.2 Battery Recharge ...................................................................................................................3-8 3.3.3 Protection fuses .....................................................................................................................3-9 3.3.4 Medical gas supply connection ............................................................................................3-10 3.3.5 Patient circuit connection .....................................................................................................3-11 3.3.6 Discharge line connection ....................................................................................................3-12 3.3.7 Use of antibacterial filters .....................................................................................................3-12 3.3.8 Nebulizer ..............................................................................................................................3-13 3.3.9 Connection of other devices.................................................................................................3-14

3.4 Ventilator use.................................................................................................................... 3-15 3.4.1 Highlights .............................................................................................................................3-15 3.4.2 Ventilator start-up - “ SELF TEST “ phase............................................................................3-17 3.4.3 Turning the ventilator off.......................................................................................................3-22 3.5 Preliminary checks – Introduction ........................................................................................3-23 3.5.1 Preliminary checks - TEST ON DEMAND ............................................................................3-24 3.5.2 O2 Sensor calibration...........................................................................................................3-25 3.5.3 Leak Test .............................................................................................................................3-28 3.5.4 Exit TEST ON DEMAND ......................................................................................................3-31 3.5.5 Preliminary checks - TEST ON DEMAND ............................................................................3-31 3.5.6 Preliminary checks - Parameters monitoring........................................................................3-34 3.5.7 Preliminary checks - Alarms.................................................................................................3-35 3.5.8 Alarms check........................................................................................................................3-37 3.5.9 Conclusions..........................................................................................................................3-39

3.6 List of preliminary checks ................................................................................................. 3-40

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Siaretron 1000 IPER XIII

4 LUNG VENTILATOR USE ....................................................................................... 4-1 4.1 General warnings................................................................................................................ 4-1

4.2 STAND-BY.......................................................................................................................... 4-2 4.2.1 Fan switch-on.........................................................................................................................4-2 4.2.2 Keyboard with soft key and encoder knob use.......................................................................4-3

4.3 Setting up the MENU language .......................................................................................... 4-4 4.3.1 SETUP screen parameters editing procedure........................................................................4-5

4.4 Setting the PATIENT DATA................................................................................................ 4-6 4.4.1 Procedure for setting the PATIENT DATA .............................................................................4-7

4.5 Erasing the PATIENT DATA............................................................................................... 4-9

4.6 Setting up the ALARMS.................................................................................................... 4-10

4.7 Operating modes and PRP parameters ........................................................................... 4-11 4.7.1 Operating mode and PRP parameters editing procedure.....................................................4-11 4.7.2 APCV (Assisted Pressure Control Ventilation) operating mode ...........................................4-13 4.7.3 APCV-TV (Volume Targeted Assisted Pressure Control Ventilation) operating mode .........4-15 4.7.4 PSV (Pressure Support Ventilation) operating mode ...........................................................4-17 4.7.5 PSV-TV (Volume Targeted Pressure Support Ventilation) operating mode .........................4-19 4.7.6 VC-VAC operating mode......................................................................................................4-21 4.7.7 VC-VAC BABY operating mode ...........................................................................................4-23 4.7.8 V-SIMV operating mode.......................................................................................................4-25 4.7.9 P-SIMV operating mode.......................................................................................................4-27 4.7.10 CPAP (Continuous Positive Airway Pressure) operating mode............................................4-29 4.7.11 APRV (Airway Pressure Release Ventilation) operating mode ............................................4-30 4.7.12 MAN operating mode ...........................................................................................................4-31 4.7.13 APNOEA BACK-UP .............................................................................................................4-32 4.7.14 Physiological respiratory parameters ( PRF ).......................................................................4-33 4.7.15 Additional respiratory parameters ........................................................................................4-35

4.8 Ventilation phase ................................................................................................................. 38 4.8.1 Ventilation interruption............................................................................................................. 40

4.9 Graphical settings and operating functions ......................................................................... 41 4.10 MAIN MENU............................................................................................................................ 46 4.10.1 MAIN MENU - SETUP............................................................................................................. 46 4.10.2 MAIN MENU - ALARMS.......................................................................................................... 46 4.10.3 MAIN MENU - TRENDS.......................................................................................................... 47 4.10.4 MAIN MENU - EVENTS .......................................................................................................... 50 4.10.5 MAIN MENU - PATIENT DATA............................................................................................... 52 4.10.6 MAIN MENU - PATIENT DATA ERASE.................................................................................. 52 4.10.7 MAIN MENU - DEFAULT PARAMETERS............................................................................... 52 4.10.8 MAIN MENU - CLOSE ............................................................................................................ 53

4.11 MAIN MENU - SETUP......................................................................................................... 54 4.11.1 SETUP options in MAIN MENU .............................................................................................. 55

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5 ALARMS................................................................................................................... 5-1 5.1 Displaying and used symbols ............................................................................................. 5-2

5.1.1 Alarms display area................................................................................................................5-2 5.1.2 A1 - Alarm area ......................................................................................................................5-3 5.1.3 A2 - ALARMS parameter, MAIN MENU .................................................................................5-4 5.1.4 A3 - General information area ................................................................................................5-5 5.1.5 A4 - Acoustic alarm silencing .................................................................................................5-7

5.2 Alarms setting ..................................................................................................................... 5-8 5.2.1 Setting of ALARMS limits values. ...........................................................................................5-8 5.2.2 Setting of ALARMS volume..................................................................................................5-10 5.2.3 Setting of DEFAULT values .................................................................................................5-12 5.2.4 Alarms DEFAULT values .....................................................................................................5-14

5.3 Troubleshooting ................................................................................................................ 5-15

6 MAINTENANCE ....................................................................................................... 6-1 6.1 Cleaning, disinfection and sterilization ............................................................................... 6-2

6.2 General indications ............................................................................................................. 6-3 6.2.1 Cleaning .................................................................................................................................6-3 6.2.2 Disinfection and sterilization...................................................................................................6-3 6.2.3 Disinfection by immersion (chemical) .....................................................................................6-4 6.2.4 Cleaning, disinfection and sterilization table...........................................................................6-5 6.2.5 Periodic maintenance.............................................................................................................6-8 6.2.6 Maintenance operations .........................................................................................................6-8 6.2.7 Cleaning, disinfection and sterilization before use with another patient ...............................6-10

6.3 Repairs and spare parts ................................................................................................... 6-11 6.3.1 Spare parts kit for lung ventilator..........................................................................................6-11

6.4 Storage ............................................................................................................................. 6-11

6.5 Repackaging and shipment .............................................................................................. 6-11

6.6 Disposal ............................................................................................................................ 6-12

A APPENDIX................................................................................................................A-1 A.1 Technical sheet...................................................................................................................A-1

A.2 Pneumatic drawing .............................................................................................................A-9

A.3 Preliminary checks............................................................................................................A-10

A.4 Table for Identification of medical gas hose colours ........................................................A-12

A.5 Glossary............................................................................................................................A-13

A.6 Electromagnetic compatibility tables ................................................................................A-18 A.6.1 ANNEX A: Table 1 .............................................................................................................. A-18 A.6.2 ANNEX B: Table 2 .............................................................................................................. A-19 A.6.3 ANNEX C: Table 3 .............................................................................................................. A-20 A.6.4 ANNEX E: Table 5 .............................................................................................................. A-21

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Siaretron 1000 IPER 1-1

1 INTRODUCTION

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. is glad to introduce this new product, result of 40 years of experience and investment in technological innovation that we are implementing in recent years.

Siare has focused heavily on innovation of materials, ergonomics and ease of use.

All routine operations have been simplified and the operational procedures are “foolproof”, in this way there is no margin for the user to make incorrect or inadequate manoeuvres.

The new device is significantly different from all previous versions and it is specifically designed for use in a hyperbaric chamber and for various medical, diving and tunnelling applications.

Even the maintenance procedures have been simplified and the parts subject to wear or deterioration have substantially decreased.

1.1 Foreseen use Siaretron 1000 IPER is a lung ventilator designed for operation in a hyperbaric chamber, to a depth of 60 metres, that can be used on adult, paediatric and neonatal patients weighing more than 3.5 Kg.

Siaretron 1000 IPER features new advanced functionalities that help you manage the operating modes and the various patient ventilation functions; the keyboard and the decoder handle simplify the settings and the operations significantly.

Hereinafter, the present manual explains how using the Siaretron 1000 IPER ventilation system and how performing some simple maintenance procedures.

SIARE recommends to read carefully the present manual and it relevant instructions before using the ventilator or proceeding to maintenance.

Please read the recommendations and the instructions herein in order to ensure a correct and safe use of Siaretron 1000 IPER both for the clinician and for the patient.

Siaretron 1000 IPER must be used only for the purposes mentioned below and in the manner described herein, therefore the clinician must thoroughly follow these instructions for use.

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1-2 User manual, DU3069100 / rev. - 02.09.2014

1.2 Main innovations Along with the 5th generation of hyperbaric ventilator, we were able to combine the ventilation function and the battery supply inside a single, unique structure.

The lung ventilator for hyperbaric chamber Siaretron 1000 IPER blends aesthetics and reliability with ergonomic structure, that makes it easy to use and to understand.

1.2.1 Matchless performance up to a depth of 60 mH2O

New absolute pressure sensor placed on the control board of the inspiratory valves.

Real time measurement of the pressure inside the hyperbaric chamber (every 100ms)

The absolute pressure sensor can read values up to 60mH2O

1.2.2 Automatic compensation of all ventilation parameters

Automatic compensation of all measured and supplied ventilation parameters, with no need of operator intervention.

The new design is based on a dedicated microprocessor only for flow compensation. That guarantees an outstanding precision and response time, breath by breath.

SIARETRON 1000 IPER is the only one ventilator with a 10 bit digital flow generator.

1.2.3 High performance Intensive care ventilator

The same functions that are necessary in ICU, finally available in hyperbaric chamber.

Siaretron 1000 IPER is equipped with a flow and/or pressure trigger, ensuring the latest ventilation methods: volume control ventilation (VC/VAC, VC/VAC-BABY), pressure control ventilation (APCV, APCV-TV), Volume or Pressure SIMV, assisted pressure (PSV, PSV-TV), CPAP, BILEVEL S-ST, SIGH, non-invasive ventilation NIV, nebulizer and Manual ventilation.

Adult, Paediatric and Neonatal ventilation thanks to an adjustable minimum Tidal volume from 5 ml to 3000 ml.

In spontaneous ventilation mode, it ensures inhalation flows up to 240 l/min, with or without support pressure.

1.2.4 PEEP and Flow By leakages compensation

PEEP up to 50 cm H2O with digital valves ensuring high precision and stability.

Flow by with automatic leakage compensation up to 60 l/min.

NIV (Non Invasive Ventilation) by means of facial mask or helmet.

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1.2.5 9” TFT LED display, five graphs displayed simultaneously

New high resolution display with low working voltage.

Easy and user friendly graphical interface.

Five graphs displayed simultaneously.

o P-t; V-t; F-t

o one loop (three available loops: P-V; P-F; F-V)

o additional parameters.

1.2.6 Compatible with premixed HELIOX

SIARETRON 1000 IPER can work with the following gas mixtures (to be set by the main menu).

o O2/AIR mixer: from 21 to 100% with automatic safety function when O2 partial pressure becomes dangerous for the patient.

o Premixed Heliox: 21, 30 or 50% (O2).

o Trimix (Heliox + AIR): soon available, under implementation.

SIARETRON 1000 IPER counterbalances all the variations of density that is specific of each gas mixture.

1.2.7 External remote control panel to facilitate the therapy inside mono-place chambers

Siaretron 1000 IPER can operate controlled by an external remote control panel, to ease the treatment inside single-seat hyperbaric chambers.

The small size of the main unit allows the installation in narrow place.

1.2.8 Small dimensions and light weight

Small dimensions (266 x 251 x 182 mm) and light weight (5.5 Kg)

Small dimensions that render Siaretron 1000 IPER easy to handle and easy to use in small spaces and during transportation.

1.2.9 Special hermetic battery

Thanks to NiMh 12Vdc / 3,3 internal battery it has been possible to have a battery autonomy of about 2 hours.

The battery can be recharged by 12 Vdc power supply or by 100/240Vac mains (outside the hyperbaric chamber)

The new hermetic battery is easily removable for service operations.

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1.3 Correct operation

For correct and complete operation, the Siaretron 1000 IPER must be:

connected to the air and oxygen outlets of the medical gas distribution system;

correctly connected to the patient circuit;

connected to a mains power supply with the same voltage as specified on the identification plate ( or supplied by internal battery );

correctly connected to all accessories and equipment necessary for the operation of the lung ventilator.

The connections with main power supply, as well as connections with medical gas distribution system must be effected according to the indications contained in the present user’s manual (see relevant chapter).

The Siaretron 1000 IPER incorporate a series of sensors for continuous patient monitoring, the most important of which are:

the flow sensors on the expiratory / inspiratory lines, are used to measure the expiratory / inspiratory volumes of the patient;

the pressure sensors, used to control the pressure of the airways or of the medical gases;

the oxygen sensor, used to measure the concentration of oxygen in the gas inspired by the patient.

the absolute pressure transducer, used to detect the operating depth, allowing the system to manage an automatic compensation of patient's volume at all depths, supplying a constant volume to the patient.

Before using the device, the clinician should check the operation of all these sensors in order to avoid any incorrect assessments of patient's condition

WARNING !! Before using it, carry out all necessary preliminary checks relative to the lung ventilator.

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Before using the ventilator on a patient it is necessary to perform a series of preliminary checking to verify the correct operation of the equipment.

The preliminary checking have the aim to verify the correct connections and functionalities of the ventilator and all its parts.

For its employ the Siaretron 1000 IPER has been designed and made to guarantee full quality of the product and its components, in order to ensure the maximum reliability of the lung ventilator for the patient and user safety

To ensure the best performance of the lung ventilator periodic maintenance of the unit by qualified technical personnel is recommended. For further information, contact SIARE Engineering International Group s.r.l.

SIARE Engineering International Group s.r.l. recommends careful reading of this manual and the relative labels before operating the lung ventilator or carrying out any maintenance..

1.3.1 Use of Siaretron 1000 IPER

The use of Siaretron 1000 IPER ventilator for hyperbaric chamber is simple and intuitive for the persons familiarised with resuscitation ventilators, a short training course being enough to learn how to use it.

A basic user interface: keyboard, encoder knob and a 9” display that simplifies the selection of the most suitable settings.

The 9” screen displays the ventilator settings and the measured data, as well as several functions, allowing the clinician to asses patient's condition immediately; you can also select and view the trend of the pressure, flow, volume, flow/volume loops, pressure/volume, pressure/flow, over time.

An immediate information management system, allows the clinician to set the alarms, collect data concerning the trend of the operating parameters (TREND) and the ventilator EVENTS log using the MENU.

The same system allows the operator to load or cancel PATIENT DATA and, if necessary, to automatically load the machine's pre-set DEFAULT PARAMETERS.

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1.4 Applicable norms

The Siaretron 4000 ICU lung ventilator is made in accordance with the following norms and it is manufactured according to UNI EN ISO 13485:2004 standards.

IEC 601-1 Medical electrical equipment - Part 1: General requirements for safety

IEC 601-1-1 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems

IEC 601-1-2 Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 601-1-4 Medical electrical equipment. Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems

IEC 601-1-8 General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 601-2-12 Medical Electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

UNI EN 1281-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

UNI EN ISO 4135 Anaesthetic and respiratory equipment - Vocabulary

DIR. 93/42/EEC Medical devices directive

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2 DESCRIPTION This section of the user manual features the main parts and components of the lung

ventilator for hyperbaric chamber Siaretron 1000 IPER (referred to from now on as ventilator) and some of its most used functionalities.

With regard to the assembly, the interface and the servicing operations, please refer to the relative chapter or contact Siare technical support service.

All figures and examples featured in this chapter are purely informative and do not refer to real clinical cases.

SIARETRON 1000 Iper : front view

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SIARETRON 1000 Iper - rear view

see 2.1 Gas supply

see 2.2 Power supply

see 2.3 Patient connections, oxygen sensor and flow sensor

see 2.4 Keyboard with soft key and encoder knob

see 2.5 9” LED display

see 2.6 Main Menu

For more information please refer to the paragraphs highlighted on the side.

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2.1 Gas supply side

11 AIR : fitting for medical air supply tube connection.

12 O2 : fitting for oxygen supply tube connection.

WARNING! Patient injury hazard The medical gases pressure should range from 280 kPa to 600 kPa (2.8 - 6 bar / 40 - 86 psi) : over the hyperbaric chamber internal pressure.

13 Fitting placed on V. EXP. Monoblock in the rear side of the ventilator, for the connection of the discharge line available in the hyperbaric chamber.

WARNING! Patient injury hazard

The discharge connector of the EXP line should be connected to a suitable lung ventilator scavenging system.

The system should grant the safety of the patient avoiding positive or negative pressures of the EXP line.

29 RS-232 connector (future availability)

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2.2 Power supply area

21 FLOW SENSOR : RJ connector for flow sensor connection

22 FUSE 6.35 AT : safety fuse for battery power circuit (1 x 6.35 AT)

23

12 VDC IN (4.2 A) : connector for external 12 Vdc 4.2 A power supply

The external supply voltage can be provided trough a battery or a supply source having the characteristics specified above.

24 I / O : ventilator supply switch

FUSE 2 x 1AT : safety fuses for 220 Vac power supply circuits

100÷240VAC 50÷60Hz 50 W : plug for mains power supply connection

25 Air intake

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2.3 Patient connections

31 FLOW SENSOR : flow sensor on patient expiratory line

32 O2 SENSOR : mechanical guard for O2 sensor electrical connection

33 INSP. TO PATIENT : inhalation fitting for patient circuit

34 NEBULIZER : outlet fitting for nebulizer circuit ( 6 l/min )

35 V.EXP (OPTION) : unused fitting

35 Transport handle

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2.4 Keyboard with soft key and encoder knob

The rear side of the ventilator features a control keyboard and an encoder knob. These components allow quick and easy use of the lung ventilator for hyperbaric chamber Siaretron 1000 IPER (referred to from now on as ventilator).

2.4.1 Encoder knob : use

ENCODER KNOB

The encoder knob is a multifunctional tool: it is used for selecting and editing all ventilator functions.

Ventilator in STAND-BY: press the encoder knob to activate the SET function (it changes color)

Turn clockwise or anti-clockwise to select the desired box (item) : e.g. MENU (changes color)

Press the knob to confirm (the box MENU changes color); you will see the MAIN MENU page at SETUP option.

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SETUP function activated (box in different color).

Press the knob; you will see the SETUP parameters page at the option LANGUAGE.

LANGUAGE function activated (box in different color).

Turn clockwise or anti-clockwise to select the desired box (item) : e.g. VOLUME (the box changes color).

VOLUME function activated: used to change the level of the volume parameter ( from 1 to 2 ); press the knob (the box changes color).

Turn it clockwise (anticlockwise) to increase (decrease) the parameter value ( from 1 to 2 ).

Press the knob to confirm the changes made to the volume parameter ( 2 ); the box changes color.

If you do not press the encoder knob within 10 sec. after selecting the parameter (or the value you want to change), the ventilator will restore the parameter value (value that you want to change), as it was before selecting it.

In order to edit other parameters: turn the encoder knob clockwise (anticlockwise).

Press the ESC soft key to go back to STAND-BY display.

After a few seconds the system automatically returns to STAND-BY or ventilator operation display.

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2.4.2 Soft keys: use

ALARM RESET

Press this key to silence the acoustic warning of an active alarm.

After removing the alarm cause, press this key once again to cancel the visual warning displayed on the screen.

ESC

Press this key to exit the “current” screen and return to the “previous” one.

START - ENTER

Press this key to start the ventilation in the pre-set mode, using the respiratory parameters set by the clinician.

STAND-BY, ON/OFF

Press the ON/OFF key to start and stop the ventilator. To access the ventilator, press the ON/OFF key. After a few seconds, on the screen will appear a series of messages indicating that the system entered the “SELF-TEST” mode ; this phase will take a few minutes.

At the end of this procedure, the system is in STAND-BY, ready to ventilate the patient. To turn de ventilator off, hold the ON/OFF key for few seconds and then confirm the action.

The system features a turn off delay that helps you prevent any accidental ventilator deactivation during operation.

Mains voltage presence indicator

If the led is on (green color), it means that the lung ventilator is powered from the mains.

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2.5 9” LED display

On the front side of the lung ventilator for hyperbaric chamber Siaretron 1000 IPER (referred to from now on as ventilator) is a 9” LED display that will show all information necessary for patient ventilation.

The main featured information: selection of the operating mode, respiratory parameters setup and display, visual and acoustic alarm warnings.

Use the control keyboard and the encoder knob on the top of the ventilator to interact directly with the display: this system is defined as GUI (graphical user interface).

The system defined with the acronym GUI is very easy to use by those who are already familiarised with lung ventilation: you an find in this paragraph all available functionalities.

You can see in the figure below how the GUI is divided into monitoring areas, parameters setup areas and alarm display areas.

2.5.1 Operative functions and graphic setting

The basic commands and functions of the ventilator are displayed and can be selected from the bottom of the screen (GUI), using the encoder knob (please see 2.4.1)

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Select the MENU function to view the MAIN MENU (please see 2.6)

Select the SET function to view/edit the operating mode and all relative physiological respiratory parameters (PRP).

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Use the CHARTS function to choose the chart type (curve or loop) that the system will display, changing if necessary its position on the screen (please see 2.5.5 or 4.9).

By enabling this function you can also see the additional respiratory parameters (if necessary).

This function is available only when the ventilation is active; please see 4.11.

“forced inspiration hold” function.

By activating this function, the system will extend the inspiration time up to 20 seconds.

“forced expiration hold” function.

By activating this function, the system will extend the expiration time up to 20 seconds.

“Nebulizer” function.

By activating this mode you can enable the nebulizer; the ventilator provides a 6 l/min flow for a period of time equal to the inspiration time.

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“100% oxygen” function

By activating this function, the ventilator will provide 100% oxygen for up to 5 minutes.

“Manual” breathing function.

By activating this function, the clinician can manually resuscitate the patient.

General information

Date (dd/mm/yy).

Time.

Battery level (if the symbol is steadily lit and green, the battery is full).

Presence of mains power supply, (the “green plug” symbol means that the device is powered from mains).

General information: please see 5.1.4.

2.5.2 Respiratory parameters monitoring

Based on the ventilator parameters set by the clinician and on the patient's characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation.

At the top of the screen, there is a led indicator that displays the pressure inside the airways in real time. The measured and monitored values are updated after each breath of the patient.

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The data in the images below refer to VC/VAC operating mode with standard PRP, and they are only informative, they do not refer to real clinical cases.

The light bar indicator (with scale from -20 to 80 cmH2O), displays the pressure inside the airways during the respiratory phase, in real time.

The value displayed is the maximum measured pressure inside the airways (cmH2O).

The displayed value shows the positive pressure at the end of the expiration: the measurement unit is cmH2O.

The clinician can control if the ventilator is able to reach and keep the PEEP pressure level set, using this value.

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The displayed value shows the real respiratory rate (number of breaths per time unit) taking into consideration for the calculation any spontaneous activity.

It shows the ratio between the inspiration time and the expiration time.

It shows the oxygen concentration value (as percentage) inhaled by the patient.

The inhaled oxygen concentration value is read by the system by means of the oxygen cell installed on the inspiratory line.

It shows the current volume value during patient's expiratory phase: the unit of measurement is ml. The value is detected by the flow sensor installed on the expiratory line.

It shows the volume value expired by the patient per minute : the unit of measurement is L/min.

You can also calculate this value using the formula: current volume (Vte) x respiratory frequency (RF).

Key

Vte : respiratory parameter

ml : unit of measurement

500 : value set by the clinician

490 : measured value

The displayed value shows the positive pressure level inside the hyperbaric chamber (10 mH2O = 1 bar).

The lung icon simulates the patient's lungs, graphically displaying the respiratory cycle by alternatively switching the lungs color (please see 2.5.6)

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2.5.3 Operative mode selection

The ventilator features the most modern ventilation methods: at volume control ventilation, pressure control ventilation, and assisted pressure ventilation.

You can select one of these ventilation modes using the SET function (please see 2.5.1).

Pressure controlled ventilation, synchronised with patient's breathing

Pressure controlled ventilation, synchronised with patient's breathing and with assured current volume.

Assisted pressure support ventilation with assured respiratory rate set by the clinician (Apnoea Back Up).

Pressure support ventilation with assured current volume and assured safety respiratory rate set by the clinician (Apnoea Back Up).

Volume-targeted controlled ventilation synchronised with the patient if the inspiratory trigger is activated.

Volume-targeted controlled ventilation synchronised with the patient if the inspiratory trigger for neonates and premature births is activated.

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Volume-targeted synchronised intermittent mandatory ventilation.

Pressure-targeted synchronised intermittent mandatory ventilation.

Positive continuous pressure applied on the airways.

Airway ventilation and pressure release: this type of ventilation features two positive pressure levels.

After selecting the most suitable operative mode for patient ventilation, the system will automatically display the respiratory parameters for the new setup.

The displayed parameters can also be set based on the type of the patient, by simply activating the function SET.

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2.5.4 Alarm signals area

The ventilator features automatic means for detecting and identifying any conditions that might put the patient at risk (based on the level of urgency and seriousness), using acoustic or visual alarm signals.

The role of the alarm signal is to draw the attention of the clinician to the event as well as to inform him on the requested response speed.

For more details and information on alarms operation, please see 5.0 Alarms.

In case of alarm, the system displays the information below:

text string referring to the active alarm

“alarm bell” symbol indicating the alarm priority and status.

You can edit the alarm settings (MENU - ALARMS) even when they are active.

After editing the alarm settings, the relative signal will remain active and the status icon will blink for a pre-set time.

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ALARM SILENCING

Press the RESET key to interrupt the acoustic signal for a pre-set

period of time.

During the silencing period, the text of the alarm will still be displayed.

Press the RESET key once again to delete the alarm text, only if the alarm activation condition is no longer present.

If during the silencing period, a new alarm (of high priority) occurs, the alarms silencing command is automatically cancelled and the acoustic and visual signals are reactivated.

WARNING! Patient injury hazard Alarms silencing. The clinician should not interrupt patient control during alarms silencing period.

2.5.5 Graphic area

The lung ventilator is equipped with tools for respiratory curves and loops display so as to quickly and accurately notify the clinician on the patient's condition.

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The graphical display function allows you to view the patient's data in real time, by means of:

PAW (Pressure) /Time curve

Flow / Time curve

Volume / Time curve

CO2 curve (graphic not available)

PAW (Pressure) / Current Volume loop

Current Volume / Flow loop

PAW (Pressure) / Flow loop

The clinician can choose from 4 different areas available on the display to place:

the various curve graphics

the additional parameters

and 1 loop area

To change the combination of charts displayed, the ventilator must be on.

Press ESC to exit “Graphic” function

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2.5.6 Graphic view : lungs icon

The lung ventilator is equipped with tools for detecting and monitoring the breathing phases. A suitable lung icon simulates the patient's lungs, graphically displaying the respiratory cycle by alternatively switching the lungs color.

The lung icon is particularly meaningful for quick patient breathing monitoring.

In fact the colouring of the icon (Trigger) in yellow highlights the patient's spontaneous activity and if the “Low Pressure” alarm value set has not been exceeded the icon turns red.

During inspiration the lungs icon turns green.

The lungs turn green during inspiration only if the PAW exceeds the “Low Pressure” alarm value set.

During expiration the lungs icon turns light grey.

At trigger activation the lungs icon is yellow.

If the “Low Pressure” limit value is not exceeded, the lungs icon turns red.

WARNING! Patient injury hazard If the “Low Pressure” alarm value set is not exceeded, the lungs icon turns red and after about 20 seconds, the system activates the low pressure alarm.

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2.5.7 Additional respiratory parameters

Based on the ventilator parameters set by the clinician and on the patient's characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation.

The clinician can use the “Graphic” function (please see 2.5.5) to define a display area for a series of additional respiratory parameters.

The data in the images below refer to VC/VAC operating mode with standard PRP, and they are only informative, they do not refer to real clinical cases (please see 4.7.14).

It shows the average calculated pressure for the airways: the unit of measurement is cmH2O.

It shows the standby pressure: the unit of measurement is cmH2O.

Use the flow sensors installed on the inspiratory line to measure that maximum inhaled flow value (measured in l/min) and to view it on the screen.

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It shows the duration of the patient's inspiratory phase: the unit of measurement is second.

It shows the duration of the patient's inspiratory standby phase: the unit of measurement is second

It shows the duration of the patient's expiratory phase: the unit of measurement is second.

It is the parameter of the lung mechanics that describes the resistance to the opposite flow of the airways: measured in cmH2O/(l/s).

It is one of the two parameters of the lung mechanics: measured in ml/cmH2O.

Use the flow sensor installed on the expiratory line to measure the exhaled flow peak.

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2.5.8 General informations

This area mainly displays two types of information:

the battery level and the mains power supply status (present / missing)

date (dd.mm.yy) and time

Indication of set hour (dd.mm.yy)

Indication of set date (hh.mm.ss)

Battery level indication

Mains power supply status indication (please see 5)

The date and time can be set using the encoder knob.

For the keyboard with soft key and encoder knob methodology of use, please see chapter 2.4.

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2.6 MAIN MENU

The MENU function is one of the most important GUI functions: in fact it allows the clinician to access the MAIN MENU area to set the basic functions for proper ventilator operation.

Before using the lung ventilator for hyperbaric chamber Siaretron 1000 IPER, please use the MENU function to set all necessary items for proper ventilator operation.

Use the encoder knob to select the MENU function and view the MAIN MENU.

Ventilator in STAND-BY: press the encoder knob to activate the SET function (it changes color)

Turn clockwise or anti-clockwise to select the desired box (item) : e.g. MENU (changes color)

Press the knob to confirm (the box MENU changes color); you will see the MAIN MENU page at SETUP option.


For more information on the MAIN MENU and on the available parameters (SETUP), please see section 4 Ventilator Use

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LANGUAGE

GRAPHIC

VOLUME

ENERGY SAVING

BRIGHTNESS

APNEA TIME

GAS SENSOR CO2 UNITS (CO2 SENSOR not available)

PASSWORD (inactive parameter)

TCP SETTING

TECHNICAL CONTACT

TEST ON DEMAND

GAS SENSOR (inactive parameter)

DISPLAY PARAMETERS COLOURS SELECTION

CLOSE

Please see ALARMS chapter (please see 5).

The clinician can check the medium, long-term trend of the most important respiratory parameters.

Vte

FR

PAW

PEEP

Vm

The clinician can check the ventilator's operation in terms of time; the system displays information on the system operation and the alarms activated during patient ventilation.

The clinician can set the patient data at the beginning of the ventilation.

The clinician can delete the previous data before a new ventilation.

The clinician can restore the default parameters (set in factory).

Back to MAIN MENU

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This page has been left blank intentionally to make front / back copying easier.

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3 PREPARATION FOR USE

The first section of this chapter describes the installation procedures for the lung ventilator for hyperbaric chamber Siaretron 1000 IPER (referred to from now on as ventilator); the second section highlights the preliminary checks to be carried out before using Siaretron 1000 IPER.

If this is the first time you install the ventilator, please read this user manual carefully.

Please clean the ventilator and sterilise its components. Use the maintenance instructions herein and follow the applicable norms in the country where the device is used.

3.1 General warnings

UNPACKING

Properly unpack the device.

Please keep the original packaging as to avoid damaging the ventilator if you have to introduce it once again in the production plant.

TRANSPORT – Changing the ventilator's location

Move the ventilator using the suitable handle.

Place the ventilator on a flat surface or on the fastening screws delivered along with the device: make sure that the ventilator cannot move accidentally during operation.

WARNING! Personal injury - physical hazard If handled incorrectly, the ventilator might tip over causing physical personal injuries to patients and/or operators.

WARNING! Accidental moving hazard

If the ventilator is not suitably placed, it might move accidentally during operation.

Place the ventilator on a flat surface.

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WARNING! Patient/clinician injury hazard

The device and all its accessories should be mounted and connected by highly qualified technical staff, suitably trained and authorised by SIARE.

Do not connect or disconnect parts or components of the ventilator when it is on or powered.

Before using it, carry out all necessary preliminary checks relative to the lung ventilator.


Before using it, carry out all necessary preliminary checks relative to the lung ventilator.



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3.2 Before use

3.2.1 Mounting the O2 sensor

WARNING! Operator injury hazard.

To avoid electric shock risk and/or components parts breakage during interventions, please make sure that the ventilator's power supply is cut off.

Thoroughly unpack the O2 cell

Insert an screw in the cell, in the space bearing the label “O2 SENSOR”.

Connect the pin to the O2 sensor.

Make sure that the RJ connector is correctly inserted in the ventilator's dedicated socket [ connector FiO2 ]

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Check the wiring of the O2 sensor.

When the ventilator is on, the system carries out a series of checks, such as electrical hook-up to O2 sensor.

“SELF TEST” phase (see chapter 4).

3.2.2 Battery Recharge

The ventilator is provided with a battery (NiMh 12Vcc / 2,2Ah) that ensures its operation for at least 120 minutes (if in perfect condition; 90 minutes, depending on the ventilation parameters), in case the mains power supply is cut off.

The battery level is constantly kept under control and therefore, when the residual autonomy lowers, the system automatically switches the battery operation. At the same time, a suitable alarm will be displayed on the ventilator's screen, along with the message “Mains power supply missing”.

The battery can be recharged by connections the ventilator to the mains (220 Vca or 12Vcc supply).

BATTERY RECHARGE If this is the first time you use the ventilator, charge up the battery for at least 8 hours.

BATTERY LIFE

The battery operation time varies as follows: old battery or not fully efficient, unusual ventilator parameters.

Insert the power supply cable plug

(220Vca) supplied with the device to the plug placed on the back of the ventilator.

Insert the power supply cable plug (220Vca) into the mains socket.

Set the main switch (placed on the back of the ventilator) to “I”.

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The mains voltage should match the one indicated on the identification plate placed on the back of the ventilator.

Make sure that on the ventilator keyboard (clinician commands area) the green led (that indicates the presence of mains power supply) is on.

BATTERY RECHARGE

In order to ensure maximum operation autonomy, make sure that the recharge time is enough: to bring the charging level from 0 to 90% you need at least 8 hours of recharge with mains supply enabled.

The ventilator must not necessarily be on.

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3.3 Preparation for use

3.3.1 Connection to power supply

The electrical hook-up is a very important phase in ventilator's installation.

Incorrect connections or connections to unsuitable power plants might affect the patient's and clinician's safety.

The power plant must comply with the prescriptions in CEI 64-8/7 standards concerning the locations intended for type A medical use.

There are three types of power supplies available on the ventilator.

Mains power supply: 100 ÷ 240Vac / 50 ÷ 60Hz / 2,4A (for use outside the hyperbaric chamber)

Low voltage power supply: 12Vcc / 4,2A (for use inside the hyperbaric chamber) Battery supply: 12Vcc – 2,2Ah NiMh battery (max. autonomy 120 minutes)

Mains power supply

The mains power supply must match the one indicated on the identification plate (mains voltage, frequency and absorption) placed on the back of the ventilator: 100 ÷ 240Vac / 50 ÷ 60Hz / 2.4A

Insert the power supply cable plug (220Vca) supplied with the device to the plug placed on the back of the ventilator.

Insert the power supply cable plug (220Vca) into the mains socket.


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WARNING! Personal injury - physical hazard In order to avoid any electric shock hazard, make sure that the supply cable is connected to an electrical socket with the grounding cable connected.

The resuscitation ventilator complies with the requirements for electro-medical devices provided in standards IEC/EN 60601-1-1 and IEC/EN 60601-1-2.

To ensure proper operation of the ventilator, please connect to it only additional devices that comply with the standards specified above.

Low voltage power supply

On the back of the ventilator is placed a suitable connector for connection to low voltage power supply line, suitable for use in hyperbaric chamber: 12Vcc / 4.2 A.

Insert the 12 Vcc power supply cable plug to the plug placed on the back of the ventilator.

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Battery power supply

There should always be a battery installed inside the ventilator.

If there is no battery, the ventilator is not protected against voltage drops or mains power supply cut off.

The ventilator should not be used without a charged battery.

The use with battery should be limited to short periods of time and should not be considered an alternative to mains power supply.

Do not open the ventilator to replace the batteries or to carry out maintenance operations on the same battery charger.

BATTERY LIFE

The battery operation time varies as follows:

old battery or not fully efficient,

unusual ventilator parameters.

BATTERY ACOUSTIC ALARM

To silence the acoustic alarm, press the “ ALARM RESET “ key placed on the front side of the ventilator.

POWER SUPPLY

When the green led placed on the front of the ventilator is on, it shows that the ventilator is properly supplied (mains power supply on).

3.3.2 Battery Recharge

You can recharge the battery by leaving the ventilator connected to the mains (using the suitable power supply cable provided); the ventilator must not necessarily operate.

To recharge the battery follow the indications in the technical data sheet (Battery recharge time).

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3.3.3 Protection fuses

There are protection fuses installed on the following circuits.

220Vca power supply : 2x1 AT

Battery power supply: 1x 6.35 AT

Fuse replacing


The operations described below must be carried out only by highly qualified staff, specifically trained and authorised by SIARE.

If a protection fuse breaks, please proceed as follows

cut off mains power supply

remove the fault or the cause that caused the fuse breakage

replace the fuse with another one that has the same value and the same technical characteristics.


Using fuses of incorrect value or with incorrect technical features might affect the ventilator's integrity and safety.

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3.3.4 Medical gas supply connection

Connect the pneumatic supply tubes for oxygen and air (supplied along with the device) to the relative ventilator couplings.

Connect the pneumatic supply tubes (O2, Air) to the relative medical gas distribution system couplings (O2, Air).

Make sure that the pneumatic supply tubes are properly connected and fixed.

PNEUMATIC SUPPLY

The supply tubes are already provided with DISS (Diameter Index Safety System) fittings for ventilator connection.

The installation technician must take care to connect the tubes with the proper fast connections, suitable for the medical gas distribution system (O2, Air).

The fast connections mounting, suitable for the medical gas distribution system, as well as all pneumatic supply tubes maintenance and/or replacement operations should be carried out only by qualified staff, so as to prevent any gas inversions that might be fatal for the patient.

In ANNEXES section you can find a table featuring the gas identification colours for the main countries.

The ventilator can also operate only with oxygen supply but in this case you will be able to adjust the FiO2 only to 99%; at start-up, the system will display an air missing alarm that you will be able to reset.

The device works with medical-type compressed air (filtered air, free of oil).

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WARNING! Unit failure risk.

In order for the device to operate as intended, the input medical gas pressure should fall within 280 kPa and 600 kPa (2.8 - 6 bar / 40 - 86 psi).

Before using the ventilator, make sure that this requirement is met.

WARNING! Supply failure risk.

If any of the medical gas supply tubes is incorrectly connected, the system will not be available in case of pneumatic supply failure.

Make sure that all medical gas supply tubes are connected according to the marking carved on the gas input block and to ventilator images.

After connecting the medical gas supply tubes, make sure that the system works properly.

3.3.5 Patient circuit connection

Connect the supplied patient circuit to the INS and EXP couplings of the ventilator.

Place the patient circuit on the patient arm circuit support (optional device).

Current volume Tubes set

< 50 mL neonatal

from 50 to 200 mL paediatric

Use a patient circuit suitable for the patient you want to treat.

> 210 mL adults

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3.3.6 Discharge line connection

Connect the discharge line prepared in the hyperbaric chamber to the coupling, fixed on the Monoblock V. EXP (rear side of ventilator).

DISCHARGE LINE Connect the ventilator discharge line to a suitable system for hyperbaric chamber.

If this operation is not carried out properly, you will face the following results.

The oxygen concentration inside the room will increase.

The air exhaled by the patient will spread inside the room (in case of infected patient).

3.3.7 Use of antibacterial filters

Use antibacterial filters on patient's circuit.


To protect the patient from any dust and particles, you must install a filter between the inspiratory tube of the respiratory circuit and the patient.


Replace the antibacterial filters as indicated in the maintenance instructions.

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You have to carry out the LOSSES TEST each time you change or replace the circuit, to check for losses and to make sure that the patient circuit is compliant.

The system will also check the patient circuit every time you start the ventilator. “SELF TEST” phase.

WARNING! Strangulation hazard.

Pay utmost attention when connecting the patient to the ventilator.

If not carefully placed, the tubes, cables, the patient circuit and other similar components installed on the ventilator might put the patient at risk.

WARNING! Burns hazard.

Do not use conductive masks or respiratory tubes during surgery with electrosurgical unit: they might cause burns.

3.3.8 Nebulizer

Connect the supplied nebulizer circuit to the suitable coupling [ NEBULIZER ] on the ventilator.

Use the command (NEB function) available on the graphical user interface (GUI) to activate the Nebulizer function

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3.3.9 Connection of other devices

Connection of Siare devices

In order to connect to the ventilator other devices manufactured by Siare, please refer to the connection instructions attached to this manual.


Do not connect to the ventilator any external devices NOT manufactured or NOT authorised by SIARE (example: discharge systems, patient simulators, etc…..), and that are not described in this user manual.

If necessary please contact SIARE or the authorised Technical Support Service available in your area.


When using additional components in the respiratory systems or configurations unsuitable for the equipment provided with the ventilator, the inspiratory and expiratory resistance might increase, exceeding the standard requirements.

If you are using this type of configurations, pay utmost attention to the values measured.

WARNING! Electrical shock risk.

In case of grounding cable malfunction, hooking-up other electrical devices to the additional ventilator outputs might cause an increase in the dispersion current beyond the allowed values.

If you connect other devices to the additional sockets, you must check the total dispersion current.

If the allowed value for total dispersion current are exceeded, do not connect the devices to the additional outputs of the anaesthesia machine, but to a separated current socket.

The entire system must comply with the requirements for electro-medical devices provided in standards IEC/EN 60601-1-1 and IEC/EN 60601-1-2.

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3.4 Ventilator use

In order to get the best performance, leave the ventilator on for at least 15 minutes before carrying out the preliminary checks.

This operation will allow the system to reach optimal spirometry conditions.

3.4.1 Highlights

Before using the ventilator on a patient, you have to carry out a series of preliminary checks to make sure that it works properly.

The purpose of the preliminary checks is to make sure that the ventilator and all its components are properly connected and operative.

You can find the list and the description of the preliminary checks at the end of this chapter, in ANNEX A.

The preliminary checks should be carried out:

every time you start and use the ventilator

every time you replace or connect an important component (patient circuit, oxygen sensor, flow sensor, etc….)

Before proceeding with the preliminary checks, the ventilator must be:

ready for use (please see Maintenance, Cleaning, Disinfection and Sterilisation)

properly placed

equipped with all accessories and devices necessary for its operation

connected to the medical gas and electrical power supply

connected to a patient simulator at the provided patient circuit terminal.

For tests and checks, please use the patient simulator SIARE cod. LS.AB.001 that is equipped with variable resistance and compliance.

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WARNING! Explosion and/or fire hazard Do not use the ventilator if you detect any suspect oxygen leaks from the ventilator or any other unit next to it.

Close all oxygen supply sources and contact the nearest Siare Support Centre or any other support centres authorised by Siare.

Accidental moving hazard.

If the ventilator is not suitably placed, it might move accidentally during operation.

Emergency conditions

In emergency conditions, the preliminary checks can be skipped.

You should carry out the preliminary checks once the emergency condition stops, and at least once a week.

PREVENTIVE MAINTENANCE

The preliminary checks do not remove the necessity for periodical preventive maintenance operations carried out by SIARE authorised staff, aimed at replacing the worn parts and checking the overall ventilator condition (please see Maintenance).

For the periodical checks that you should carry out, please refer to Maintenance chapter.

WARNING! Patient/clinician injury hazard All maintenance and/or repair interventions require full knowledge of the ventilator, and therefore such operations must be carried out only by highly qualified staff, specifically trained and authorised by SIARE.

WARNING! Serious patient injuries All figures and examples featured in this chapter are purely informative and do not refer to real clinical cases.

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3.4.2 Ventilator start-up - “ SELF TEST “ phase



Hold the STAND-BY / ON-OFF key for few seconds to start the ventilator.

The ventilator starts and the automatic “ SELF TEST “ phase begins.

PATIENT CIRCUIT In order to carry out the “ SELF TEST “ correctly, close or plug the Y-shaped coupling of the patient circuit, as requested on the display screen.

“SELF TEST” phase. During “ SELF TEST “ phase, the ventilator software carries out the self-diagnostic tests and checks a series of devices necessary for safe ventilator operation.

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Turbine operation parameter check (Missing operative function).

Turbine Absent

Check the Oxygen input pressure. Oxygen Input

Check the Air input pressure. Air Input

Check the operation of the Inspiratory Flow sensor. Insp. Flow Sensor

Check the operation of the Expiratory Flow sensor. Exp. Flow Sensor

Check the operation of the pressure sensor by checking PAW reading.

Pressure sensor

Check the patient circuit connection by verifying if there is any pressure.

Patient circuit

Check the battery voltage value. Battery

Check the connection of the O2 sensor. Oxygen sensor

The clinician should check if the system generates the acoustic signal, he can confirm the test by silencing the alarm.

Acoustic alarm

For a more correct and detailed analysis of the issues arising during SELF TEST “ phase, please consult the service manual.

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The “ SELF TEST “ phase completed successfully.

Acoustic alarm operation check. If you do not hear any acoustic signal and/or you did not press the Alarm Reset key, on the screen will appear the message “Press START to begin anyway” in red.

The “ SELF TEST “ phase did not complete successfully.

WARNING! Patient/clinician injury hazard The “ SELF TEST “ phase did not complete successfully. Please see chapter 5 and contact the nearest Siare Support Centre or any other support centres authorised by Siare.

However, the system allows you to proceed. Press START.

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The “ SELF TEST “ phase completed successfully.

The “ SELF TEST “ phase completed successfully, you can:

go to TEST ON DEMAND by pressing ESC.

go to STAND-BY operating mode, by pressing START.

After completing the “ SELF TEST “ phase, press ESC to go to TEST ON DEMAND.

TEST ON DEMAND

TEST ON DEMAND By means of this function you can:

calibrate the oxygen cell

check for any ventilator leaks

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After completing the “ SELF TEST “ phase, press

ESC to go to TEST ON DEMAND.

STAND-BY operating mode

STAND-BY After carrying out the SELF TEST or before turning the ventilator off, it automatically switches to this operating mode.

In this operating mode you can set and/or edit all ventilator parameters relative to the operating mode that you will use on the patient that you want to treat.

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3.4.3 Turning the ventilator off

STAND-BY operating mode.

Hold the STAND-BY / ON-OFF key for few seconds to turn the ventilator off.

Turning the ventilator off

The ventilator goes back to

STAND-BY operating mode.

The ventilator turns off.

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3.5 Preliminary checks – Introduction

WARNING! Patient injury hazard All figures and examples featured in this chapter are purely informative and do not refer to real clinical cases.

The preliminary checks are divided in 4 phases:

TEST ON DEMAND o O2 Sensor calibration

o Leak Test

Ventilator o Respiratory parameters

o Spirometry

Ventilator alarms

WARNING! Lung ventilator failure risk. Running or cancelling the preliminary checks might result in a malfunction during ventilator operation: pay utmost attention.

Always carry out all preliminary checks, unless there is an emergency situation.

You should carry out the preliminary checks once the emergency condition stops, and at least once a week.

The ventilator must be ready for use in order for you to proceed with the preliminary checks.

Connect the power supply, the medical gases (O2 and Air) and the patient circuit.

Insert and wire the oxygen sensor

Connect a patient simulator to the patient circuit terminal.

Ventilator in STAND-BY operating mode.

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3.5.1 Preliminary checks - TEST ON DEMAND

To carry out the TEST ON DEMAND you must know the keyboard operating mode and the options available in the ventilator MENU (please see chapter 2).

Press and turn the encoder knob (referred to from now on as knob) until activating the MENU function.

MENU function active: press the knob; the system will display the MAIN MENU screen, SETUP option.

SETUP function active: press the knob; the system will display the page containing the parameters you want to set and/or check for LANGUAGE option.

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Turn the knob to activate the option in the MAIN MENU - SETUP - TEST ON DEMAND.

TEST ON DEMAND function active: press the knob; TEST ON DEMAND will be displayed.

Oxygen sensor calibration

Pneumatic circuits leak test

3.5.2 O2 Sensor calibration

WARNING! Ventilator malfunctions risk

This procedure should be carried out to check the proper operation of the O2 sensor.

To avoid any patient injury risks, carry out this procedure weekly.

Turn the knob to select the desired ADDITIONAL TEST: O2 Sensor calibration.

Press the knob; the system will activate the oxygen sensor calibration.

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Oxygen sensor calibration procedure in progress.

To check if the O2 sensor works properly, the software reads the electrical value (mV) generated by the cell when immersed in a pure oxygen flow generated by the ventilator during the test.

When the O2 Sensor Calibration is completed, the system displays a suitable message (if the cell is new and in perfect condition): Test Completed (60mV).

The oxygen sensor calibration procedure was completed successfully: the measured voltage value is 58mV.

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The message Test Completed (60mV) shows the correct value, under voltage, of the sensor at 100% oxygen.

Conditions to be met for proper calibration: the O2 sensor must be placed in its seat;

the O2 must be electrically connected through the suitable cable;

the medical gases must be properly connected.

If any of these conditions is not met, the calibration cannot be successful.

REPLACING THE OXYGEN CELL

The oxygen cell must be replaced when, at the end of the calibration phase, appears a detected voltage value lower than 25mV and/or if the the system displays the relevant alarm message.

To order the replace sensor and to dispose of the worn one, please see chapter “ Maintenance “.

The oxygen sensor calibration procedure was not completed successfully.

WARNING! Ventilator malfunctions risk If the TEST result is negative check:

if the O2 sensor is installed and electrically connected to the ventilator

if the O2 sensor is worn out (the oxygen detection cell is worn out): replace the O2 sensor

if the medical gases are properly connected

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TEST ON DEMAND FAILED

If the system does not exceed the preliminary checks phase, please see chapter Alarms - Trouble Shooting or contact the nearest Siare Support Centre or any other support centres authorised by Siare.

3.5.3 Leak Test

WARNING! Ventilator malfunctions risk This test makes sure that there are no leaks greater than 100 ml/min

inside the pneumatic circuits of the lung ventilator. To avoid any patient injury risks, carry out this procedure weekly.

Turn the knob to select the desired ADDITIONAL TEST: Leak Test.

Press the knob; the system will activate the Leak Test.

Close the patient circuit (manually close the patient circuit coupling).

Press the START key to begin the procedure.

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The leak test procedure is in progress.

The leak test procedure was completed successfully.

Based on known, calculated data (flow, pressure and time), the software calculates the parameters displayed on the screen.

The compliance values detected during Leak Test are used for the “dead space compensation” ( e.g. 2.5 x cmH2O measured).

Range of values accepted by the Leak Test Min. Max.

Patient circuit compliance 0.2 4

Leak (ml/min) 0 100

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WARNING! Ventilator malfunctions risk If the pressure (during leak test for patient and pneumatic circuits) does not reach 30 cmH2O, the test is failed.

Leak test procedure failed.

WARNING! Ventilator malfunctions risk If the TEST result is negative make sure that:

the lung ventilator is in STAND-BY the patient circuit is properly connected to the flow sensor and INSP

coupling the patient circuit Y is properly closed/plugged. the lung ventilator generates a flow.

TEST ON DEMAND FAILED

If the system does not exceed the preliminary checks phase, please see chapter Alarms - Trouble Shooting or contact the nearest Siare Support Centre or any other support centres authorised by Siare.

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3.5.4 Exit TEST ON DEMAND

Gas Sensor - Zero Reference Calibration

Function not ACTIVE.

Turn the knob to select the option: Exit.

Exit TEST ON DEMAND

Press the encoder knob; the system will leave the TEST ON DEMAND screen.

Press the ESC soft key; the system will leave the TEST ON DEMAND screen.

3.5.5 Preliminary checks - TEST ON DEMAND

To carry out the preliminary checks you need to know how the encoder keyboard and the Physiological Respiratory Parameters (referred to from now on as PRP) work.

Preliminary checks to be carried out on the ventilator.

Respiratory parameters setup.

Spirometry proper operation check.

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In order to carry out the preliminary checks, proceed as follows.

1) Ventilator in STAND-BY.

2) Select and operating mode (VC-VAC).

Press the knob: the system will activate the SET function.

Press the knob once again: the system will display the respiratory parameters.

Modification of the PRP

Turn the knob, select the parameter you want to change, press the knob to activate the value editing function.

Turn the knob clockwise to increase (anticlockwise to decrease) the value of the selected parameter.

Press the knob to confirm the modification.

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3) Set the respiratory parameters (PRP)

Vti RR I:E

Tr. I

Pause PEEP

O2

500 15 1:2 -1 cmH2O 1 L/min 0 0, 5, 10 cmH2O

21%

4) Press the START button: the ventilator begins its cycle.

For tests and checks, please use the patient simulator SIARE cod. LS.AB.001 that is equipped with variable resistance and compliance.

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3.5.6 Preliminary checks - Parameters monitoring

Based on the PRP set by the clinician and on the patient's [patient simulator] characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation.

Before checking the value of the set parameters, leave the ventilator on for at least 10 minutes. This way the system will be able to reach its operating condition.

5) Check the compliance between the parameters set and those monitored.

In the middle of the screen the system displays the operating curves.

On the top of the screen you can see the monitored parameters.

6) Change the PRP values.

PEEP : 5, 10 cmH2O

Tr. I : -1 cmH2O, 1 L/min

O2 : 99%

7) Check the correspondence between the monitored parameters and the displayed curves.

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Ventilator operation check Make sure that the airways pressure increases during the inspiratory

phase.

Make sure that the airways limit pressure intervenes (pressometric operating mode).

Make sure that the variation in the set oxygen concentration value (O2 %) corresponds.

Make sure that the ventilator responds properly at parameters variation..

Make sure that that the Trigger works properly.

Make sure that the values set for respiratory frequency and volume are properly displayed and the pressure, volume and flow curves match the monitored parameters

Make sure that the alarms intervene properly.

In the upper side of the screen you can see the monitored parameters: allows tolerance +/- 15% of the set value.

If the measured values for Vte and O2 differ from the value set with more than 20%, repeat the “TEST ON DEMAND” procedure.

3.5.7 Preliminary checks - Alarms

To carry out the preliminary checks relative to ventilator's alarms, you need to know how the keyboard and the alarms work: please refer to the relative chapters.

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Press and turn the knob: the system will activate the MENU function.

Press the knob once again; the system will display the MAIN MENU screen, SETUP option.

Turn the knob: the system will activate the ALARMS option.

Press the knob: the system will activate the ALARMS page.

Check the alarms setup and if necessary change the values set, based on the test you want to carry out.

Turn the knob, select the alarm you want to change, press the knob to activate the value editing function.

Turn the knob clockwise to increase (anticlockwise to decrease) the value of the selected alarm.

Press the knob to confirm the modification of the alarm value.

Exit the ALARMS screen

Press the ESC soft key; the system will leave the ALARMS screen.

After about 60 seconds the system automatically returns to STAND-BY or ventilator operation display.

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3.5.8 Alarms check

Check the alarms setup, and change the set values whenever necessary (please see previous paragraph).

Ventilator in VC/VAC operating mode.

Press the START button: the ventilator begins its cycle.

Set the low pressure alarm limit to 5 cmH2O.

Disconnect the patient simulator from the patient circuit during ventilation.

After about 20 seconds the system activates the airways low pressure alarm: silence the alarm.

Reconnect the patient simulator.

LOW PRESSURE

Set the high pressure alarm limit to 45 cmH2O.

Block the patient simulator (using your hands) during ventilation.

The system activates the airways high pressure alarm: silence the alarm.

Unlock the patient simulator.

HIGH PRESSURE

Set the low low frequency (high frequency) alarm limit to 15 bpm (15 bpm).

During ventilation please set RR = 10 bpm (RR = 20 bpm).

The system activates the low (high) frequency alarm: silence the alarm.

Restore the default alarm value.

LOW FREQUENCY (HIGH FREQUENCY)

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Set the low expired Vt alarm limit to 100 ml.

During ventilation, set it to 50 ml.

The system activates the low expired Vt alarm: silence the alarm.


LOW EXP. VOLUME

Set the high expired Vt alarm limit to 500 ml.

During ventilation, set it to 750 ml.

The system activates the high expired Vt alarm: silence the alarm.


HIGH EXP. VOLUME

Set a FiO2 concentration > than 50% on the ventilator.

Close the Oxygen gas supply.

The system activates the low FiO2 alarm: silence the alarm.

Restore the Oxygen gas supply.

LOW O2 CONCENTRATION

Set a FiO2 concentration < than 50% on the ventilator.

Close the Air gas supply.

The system activates the high FiO2 alarm: silence the alarm.

Restore the Air gas supply.

HIGH O2 CONCENTRATION

During ventilation, set the main power supply switch to OFF ( 0 ).

The system activates the mains power failure alarm: silence the alarm.

Restore the main switch and set it to ON ( I ).

POWER FAILURE

Close the medical gas supply during ventilator operation.

The system activates the gas supply failure alarm: silence the alarm.

Restore the medical gas supply.

LOW AIR SUPPLY

LOW O2 SUPPLY

WARNING! Severe patient injuries

The alarms must trigger at the proper time and in the correct manner.

Check the proper activation of the visual and acoustic signals.

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3.5.9 Conclusions

Carry out all preliminary checks and make sure that they were completed successfully before connecting the patient to the ventilator.

Preliminary checks phase failed:

please see Alarms chapter and/or Trouble Shooting chapter;

please contact the nearest Siare Support Centre or any other support centres authorised by Siare.


Check the alarms set values before connecting a patient to the ventilator.

Change the alarms setup based on the clinical situation.

WARNING! Operator and patient injury hazard

The intensive care ventilator must be inspected and serviced once it reaches 1000 hours of operation or, in case of limited use, at least once every 6 months.

All maintenance and/or repair interventions require full knowledge of the ventilator, and therefore such operations must be carried out only by highly qualified staff, specifically trained and authorised by SIARE.

Any improper intervention or unauthorised modification may affect the device's safety, putting the patient at risk.

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3.6 List of preliminary checks

3.5 Preliminary checks - Introduction 3-23

3.5.1 Preliminary checks - TEST ON DEMAND 3-24

3.5.2 O2 Sensor Calibration 3-25

3.5.3 Leak Test 3-28

3.5.4 Exit TEST ON DEMAND 3-31

3.5.5 Preliminary checks - Lung ventilator 3-31

3.5.6 Preliminary checks - Parameters monitoring 3-34

3.5.7 Preliminary checks - Alarms 3-35

3.5.8 Alarms check 3-37

3.5.9 Conclusions 3-39

3.6 List of preliminary checks 3-40

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4 LUNG VENTILATOR USE

This chapter shows you how to use the lung ventilator for hyperbaric chamber Siaretron 1000 IPER (referred to from now on as ventilator).

Thoroughly read this chapter and the entire manual to make sure respiratory parameters and alarm limits are set correctly and choose the most suitable ventilation mode.

The clinician must choose the operating modes and the alarm limits that best match patient's physiological state and pathologies.

4.1 General warnings


Before starting the ventilator you have to:

carry out the preliminary checks (please see the previous chapter)

set the language and the patient data (please see 4.3)

set and check the alarms limits (please see 4.4)

set the physiological respiratory parameters and the operating mode that match the patient's clinical situation best (please see 4.7)

Before subjecting the patient to a lung ventilation treatment, please:

set the airway pressure limit alarm to a value that does not exceed 20 cmH2O; this way you will prevent any problems that might arise due to incorrect respiratory volume or frequency setup (you can increase the pressure if the patient's pathology and conditions require such modification)

check the set oxygen concentration (FiO2) as high concentrations might affect the patient's health

please consult this Manual



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4.2 STAND-BY

4.2.1 Fan switch-on



Hold the STAND-BY / ON-OFF key for a few seconds to start the ventilator.

The ventilator starts and the automatic “ SELF TEST “ phase begins

PATIENT CIRCUIT

In order to carry out the “ SELF TEST “ correctly, close or plug the Y-shaped coupling of the patient circuit, as you can see on the display screen.

“SELF TEST” phase.

During “ SELF TEST “ phase, the ventilator software carries out the self-diagnostic tests and checks a series of devices necessary for safe operation of the ventilator.

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After completing the “ SELF TEST “ phase successfully, press START to go to STAND-BY mode.

STAND-BY operating mode

STAND-BY

After carrying out the SELF TEST or before turning the ventilator off, it automatically switches to this operating mode.

In this operating mode you can set and/or edit all ventilator parameters (SETUP, ALARMS, etc…) relative to the operating mode that you will use on the patient that you want to treat.

In STAND-BY (SET function) you can select the operating mode and set and/or edit all ventilator parameters (PRP) that belong to the operating mode in question.

The PRP can also be adjusted while the ventilator runs, adapting them to the patient's clinical situation.

4.2.2 Keyboard with soft key and encoder knob use

For the keyboard with soft key and encoder knob methodology of use, please see chapter 2.4.

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4.3 Setting up the MENU language

Ventilator in STAND-BY

Press the encoder knob: the system will activate the SET function

Select the MENU box

Press the knob to confirm your choice; you will see the MAIN MENU page at SETUP option.

Press the knob to confirm your choice

The system will display the SETUP screen, LANGUAGE (LANGUAGE - Italian) option

To change the MENU language proceed as described herein (please see 2.4):

press the encoder to apply the Language change

turn clockwise (anticlockwise) to select the desired language

press the knob to confirm.

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4.3.1 SETUP screen parameters editing procedure

To change other parameters proceed as described herein (please see 2.4):

turn the encoder knob clockwise (anticlockwise) to select another option from the SETUP screen

press the encoder to apply the change

turn clockwise (anticlockwise) to select the new value


Press ESC to exit the SETUP screen and go back to STAND-BY screen.

Wait for the system to return to STAND-BY screen automatically.

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4.4 Setting the PATIENT DATA



Select the MENU box

Press the knob to confirm your choice; you will see the MAIN MENU page at SETUP function.

Turn the knob to select the PATIENT DATA option

Press the knob to confirm your choice; you will see the PATIENT DATA page.

Press the ESC soft key

to exit PATIENT DATA screen.

select CLOSE option and press the encoder

wait for the system to return to STAND-BY screen automatically.

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4.4.1 Procedure for setting the PATIENT DATA

You can see below how to enter the patient name (this is shown only as an example).

Use the encoder knob to enter the patient's identification data.

The fields for entering the name and surname have a limit of 14 characters.

The lower-case letters are placed after the upper-case letters.

To save the data inserted in each parameter (e.g. Name), you have to scroll through all 14 available character spaces.

Ventilator displaying the PATIENT DATA screen.

Turn the encoder knob to select the first parameter you want to set, Name.

Press the knob to activate the text insertion inside Name box (the first character space appears).

Turn the knob to enter “the first letter” of the patient name (first the upper-case letters, then the lower-case letters).

Press the knob to confirm the letter entered in the first highlighted text box (the second character space appears),

Turn the knob to enter “the second letter” of the patient name (first the upper-case letters, then the lower-case letters).

Press the knob to confirm and turn it again to proceed with entering the rest of the patient's name.

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To save the first parameter, Name (and the others) you have to scroll through all characters spaces available for each parameter.

After setting the Patient's Name the clinician can proceed in the same manner to fill in the entire PATIENT DATA sheet.

After entering all patient identification data, select the CLOSE box and press the encoder.

PATIENT DATA

The entered identification data can be edited in the same manner.

Press the ESC soft key to exit a patient identification data field, without scrolling through all available character spaces.

Press the PATIENT DATA ERASE function to delete the patient identification data saved in the system.

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4.5 Erasing the PATIENT DATA



Select the MENU box


Turn the knob to select the option ERASE PATIENT DATA

Press the knob to confirm your choice; you will see the page ERASE PATIENT DATA.

To exit the ERASE PATIENT DATA screen

press the ESC soft key


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4.6 Setting up the ALARMS



Select the MENU box


Turn the knob to select the option ALARMS

Press the knob to confirm your choice; you will see the page ALARMS .

For ALARMS parameters and limits setup please see 5.2 ALARMS setup.

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4.7 Operating modes and PRP parameters

The information in this chapter refers to the physiological respiratory parameters (referred to from now on as PRP), that are available based on the ventilation type and in the following pages you will find a description of the operating modes available on Siaretron 1000 Iper.


Thoroughly read this chapter and the entire manual to make sure you set the PRP correctly and choose the most suitable ventilation mode.

The clinician must choose the operating modes that match the patient's physiological features and pathologies best.

4.7.1 Operating mode and PRP parameters editing procedure


Press the encoder knob; the system will activate the SET function (changes colour).

Press the encoder knob; the system will activate the SET function (changes colour).

The system will display all PRP relative to the set operating mode.

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At start-up the system will display the default parameters and values.

At start-up, the system restores the parameters and values set and memorised before the last shut-down.

The procedure for setting a new operating mode or for editing the PRP values, implies using the encoder knob and the control keyboard as described herein (please see 2.4):

turn the encoder knob clockwise (anticlockwise) to select an option from the screen

press the encoder to apply the change

turn clockwise (anticlockwise) to select the new value


To exit SET screen

press the ESC soft key


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4.7.2 APCV (Assisted Pressure Control Ventilation) operating mode

Pressure controlled ventilation, synchronised with patient's breathing.

The system displays all PRP relative to the set operating mode.

APCV is a pressure controlled ventilation, synchronised with the patient's breathing.

With this parameters configuration, APCV is a pressure controlled ventilation, synchronised with the patient's breathing, during which the system generates a ventilates the patient at a pre-set inspiratory pressure (PLIM), a pre-set flow (Flow), a calculated I:E ratio and a settable respiratory rate (RR).

In APCV the current volume depends on the limit pressure (PLIM) and on the patient's lungs characteristics (compliance, lung capacity) therefore the tidal volume will vary depending on changes in lung mechanics.

During the inspiratory phase, the ventilator generates a settable flow (Flow). When the airway pressure reaches the control value (PLIM), this pressure level is kept constant by the ventilator until the end of the inspiration that you can set using (RR).

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Use the settable parameters to define an inspiratory trigger (Trig. I) used to set a flow expressed in litres per minute (or a pressure in cmH2O) that represents the limit for detecting the patient's spontaneous breathing attempt. The greater the value, the greater the patient's effort to breath.

If the pressure set is not reached, make sure that the patient circuit is perfectly sealed and that the PRP parameters are properly set.

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4.7.3 APCV-TV (Volume Targeted Assisted Pressure Control Ventilation) operating mode

Pressure controlled ventilation, synchronised with patient's breathing and with assured current volume.


APCV-TV is a pressure controlled ventilation, synchronised with the patient's breathing (automatic PLIM) with assured current volume (Vte).

The system generates a ventilation at automatic inspiration pressure (automatic PLIM), in order for the expired volume to equal the volume set (Vte).

During the inspiratory phase, the ventilator generates an automatic flow. When the pressure reaches the control value inside the airway (automatic PLIM, at maximum Pmax ), this pressure level is kept constant by the ventilator until the end of the inspiration that you can set using the (RR) and the I:E ratio.

Use the settable parameters to define an inspiratory trigger (Trig. I) used to set a flow expressed in litres per minute (or a pressure in cmH2O) that represents the limit for detecting the patient's spontaneous breathing attempt. The greater the value, the greater the patient's effort to breath.

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4.7.4 PSV (Pressure Support Ventilation) operating mode

Assisted pressure support ventilation with assured safety respiratory rate, set by the clinician (Apnoea Back Up).


PSV is an assisted type of ventilation with pre-set pressure support (PS) with assured safety respiratory rate set by the clinician in case of patient apnoea (RR bk).

PSV can be used to sustain spontaneous ventilation for patients with stabilised ventilation needs or who are in weaning phase.

Therefore keep in mind that, in order to have the ventilator's support, using the PSV, the patient must be able to inhale and therefore you cannot use this operating mode to ventilate a patient who is sedated or paralysed.

PSV is a ventilation technique during which, at the beginning of the patient's spontaneous inspiratory effort, the ventilator provides a constant positive support pressure (PS) pre-set by the clinician with high-speed flow supply, until the pressure inside the airway reaches the desired support value.

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When the set support pressure is reached, the expiration takes the place of the inspiration (according to Trig E - percentage of the inspiratory flow peak beyond which the expiration can begin).

This technique saves the patient from the work of breathing, as he only has to reach the small quota necessary to enable the ventilator trigger (Trig I). This way, the patient is the one who sets the respiratory rate, the current volume (based on the physiological characteristics) and the beginning of the inspiratory and expiratory phases.

With optimal PSV, the breathing pattern can be standardised (by increasing the Vte and reducing the respiratory rate) and the work of breathing can be reduced, improving the respiratory exchange ratios.

In this mode the patient's work of breathing is assumed by the ventilator. Each breath initiated by the patient (Trig I activated) is supported by the ventilator, that sends a gas flow inside the airway, at a certain pre-set pressure, called support pressure (PS).

If the patient does not require spontaneous breathing during the apnoea time (set in MAIN MENU - SETUP), the system activates the APNOEA acoustic and visual alarm.

The system will automatically provide an APCV ventilation with set safety respiratory rate (RR bk) and I:E ratio (I:E bk).

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4.7.5 PSV-TV (Volume Targeted Pressure Support Ventilation) operating mode

Pressure support ventilation with assured current volume and assured safety respiratory rate set by the clinician (Apnoea Back Up).


PSV-TV is an assisted pressure support ventilation with assured current volume and assured safety respiratory rate set by the clinician in case of patient apnoea (RR bk).

PSV-TV can be used to sustain spontaneous ventilation for patients with stabilised ventilation needs or who are in weaning phase.

Therefore keep in mind that, in order to have the ventilator's support, using the PSV-TV, the patient must be able to inhale and therefore you cannot use this operating mode to ventilate a patient who is sedated or paralysed.

PSV-TV is a ventilation technique during which, at the beginning of the patient's spontaneous inspiratory effort, the ventilator provides support at an assured volume (Vte) pre-set by the clinician.

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When the Vte pre-set value is reached, the expiration takes the place of the inspiration (according to Trig E - percentage of the inspiratory flow peak beyond which the expiration can begin).

This technique saves the patient from the work of breathing, as he only has to reach the small quota necessary to enable the ventilator trigger (Trig I). This way, the patient is the one who sets the respiratory rate, the beginning of the inspiratory and expiratory phases.

In this mode the patient's work of breathing is assumed by the ventilator. Each breath initiated by the patient (Trig I activated) is supported by the ventilator, that sends inside the airway an assured tidal volume, pre-set by the clinician.

If the patient does not require spontaneous breathing during the apnoea time (set in MAIN MENU - SETUP), the system activates the APNOEA acoustic and visual alarm.

The system will automatically provide an APCV ventilation with set safety respiratory rate (RR bk) and I:E ratio (I:E bk).

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4.7.6 VC-VAC operating mode

Volume-targeted controlled ventilation synchronised with the patient if the inspiratory trigger is active.


VC/VAC is a volume-targeted controlled ventilation (Vti), synchronised with the patient's breaths if the inspiratory trigger (Trig. I) is active.

In this type of ventilation the work of breathing is fully assumed by the ventilator, and therefore it is used when the patient is unable to breath on his own, or in order to assure an efficient pre-set current volume and therefore the mechanical ventilation must fully replace the spontaneous breathing.

The inspired volume (Vti) is pre-set and generated in a pre-set time (RR and I:E) and determines the characteristics and the pressure range necessary to reach the pre-set amount of gas mixture that must be provided. The patient's breathing attempt is detected by the system (Trig I) and it automatically sends inside the airway a gas flow at a pre-set volume (Vti).

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To combine the assisted mode with the control mode, the clinician must adjust the trigger sensitivity (Trig. I) at a value that suits the patient. If during the expiratory phase, the patient generates a spontaneous breath that activates the trigger, the ventilator will synchronise its activity to the patient's spontaneous breath, recalculating the I:E cycle times starting from that event and displaying them on the ventilator screen.

This way the ventilator provides a minimum number of breaths as indicated on the RATE display of the integrated screen. If the patient's spontaneous breathing respiratory rate is greater (than the respiratory rate set on the ventilator) the machine will increase the number of breaths per minute (with regard to the number set in the control panel) and displays the value on the integrated monitor.

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4.7.7 VC-VAC BABY operating mode

Volume-targeted controlled ventilation synchronised with the patient if the inspiratory trigger for neonates and premature births is active.


VC/VAC BABY is a volume-targeted controlled ventilation (Vte), synchronised with the patient's breaths if the inspiratory trigger (Trig. I) is activated.

With regard to the VAC mode previously described, this operating mode, that is dedicated to neonatal patients, features an additional parameters that identifies the maximum pressure limit that can be reached during ventilation.

In this type of ventilation the work of breathing is fully assumed by the ventilator, and therefore it is used when the patient is unable to breath on his own, or in order to assure an efficient pre-set current volume and therefore the mechanical ventilation must fully replace the spontaneous breathing.

The volume (Vte) is pre-set and generated in a pre-set time (RR and I:E) and determines the characteristics and the pressure range necessary to reach the pre-set amount of gas mixture that must be provided.

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The patient's breathing attempt is detected by the system (Trig I) and it automatically sends inside the airway a gas flow at a pre-set volume (Vte).

To combine the assisted mode with the control mode, the clinician must adjust the trigger sensitivity (Trig. I) at a value that suits the patient. If during the expiratory phase, the patient generates a spontaneous breath that activates the trigger, the ventilator will synchronise its activity to the patient's spontaneous breath, recalculating the I:E cycle times starting from that event and displaying them on the ventilator screen.

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4.7.8 V-SIMV operating mode

Intermittent delivery volume-targeted synchronised ventilation.


SIMV is a synchronised intermittent mandatory ventilation, during which the ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set volume (Vti).

SIMV allows the patient to breath spontaneously, between the forced breaths, with a pre-set positive pressure support (PS) if the patient's breath is strong enough to activate the flow trigger (Trig. I). The spontaneous phase is characterised by the set inspiration time (Ti) that once the pressure support value (PS) set by the clinician is reached, leaves its place to the expiration phase (Trig. E).

Therefore, in SIMV mode, the ventilator can provide a combination of spontaneous and controlled breathing. SIMV mode is frequently used as a transition ventilation mode from full ventilatory support to remote ventilatory assistance (weaning).

If you set the RRsimv to OFF (RRsimv 0) you will obtain the actual SPONT (spontaneous ventilation). The ventilator helps the patients' spontaneous breathing as if it were set to assisted mode (PSV), respecting the set airway pressure limit.

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At this point the weaning is completed; the patient is weaned and breaths on his own.

Pay particular attention to trigger setup: if too high, or completely excluded, in order for the patient to survive he must have full breathing efficiency.


With RRsimv set to OFF (RRsimv 0) the patient can breath spontaneously.

If the patient does not require spontaneous breathing during the Apnoea time (set in MAIN MENU - SETUP), the system activates the low PAW acoustic and visual alarm (low airway low pressure).

The graphic shows how the SIMV operating mode works.

The spontaneous activity between one synchronised breath and the other is 70% managed in pressometric mode (PS) while the remaining 30% represents the window for the activation of the forced synchronised breathing.

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4.7.9 P-SIMV operating mode

Intermittent delivery pressure-targeted synchronised ventilation.


SIMV is a synchronised intermittent mandatory ventilation, during which the ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set limit pressure (PLIM) providing pressure support (PS) during the spontaneous phase.

SIMV allows the patient to breath spontaneously, between the forced breaths, with a pre-set positive pressure support (PS) if the patient's breath is strong enough to activate the flow trigger (Trig. I). The spontaneous phase is characterised by the set inspiration time (Ti) that once the pressure support value (PS) set by the clinician is reached, leaves its place to the expiration phase (Trig. E).

Therefore, in SIMV mode, the ventilator can provide a combination of spontaneous and controlled breathing. SIMV mode is frequently used as a transition ventilation mode from full ventilatory support to remote ventilatory assistance (weaning).

If you set the RRsimv to OFF (RRsimv 0) you will obtain the actual SPONT (spontaneous ventilation). The ventilator helps the patients' spontaneous breathing as if it were set to assisted mode (PSV), respecting the set airway pressure limit.

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At this point the weaning is completed; the patient is weaned and breaths on his own.

Pay particular attention to trigger setup: if too high, or completely excluded, in order for the patient to survive he must have full breathing efficiency.


With RRsimv set to OFF (RRsimv 0) the patient can breath spontaneously.

If the patient does not require spontaneous breathing during the Apnoea time (set in MAIN MENU - SETUP), the system activates the low PAW acoustic and visual alarm (low airway low pressure).

The graphic shows how the SIMV operating mode works.

The spontaneous activity between one synchronised breath and the other is 70% managed in pressometric mode (PS) while the remaining 30% represents the window for the activation of the forced synchronised breathing.

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4.7.10 CPAP (Continuous Positive Airway Pressure) operating mode

Positive continuous pressure applied on the airway.


CPAP is a spontaneous positive pressure ventilation at continuous flow.

In this operating mode the patient is free to breath spontaneously inside the circuit but at a pressure greater than the atmospheric one, with increased residual functional capacity.

During spontaneous breathing the pressure value varies around the set value, it tends to drop when the patient inhales and to rise when the patient exhales.

If during spontaneous breathing the patient does not reach the airway low pressure limit (LOW PAW), after 20 seconds the system activates the relative alarm.


If the patient stops breathing, after 20 seconds the system activates the low PAW acoustic and visual alarm (low airway low pressure).

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4.7.11 APRV (Airway Pressure Release Ventilation) operating mode

Airway ventilation and pressure release: this type of ventilation features two positive pressure levels.


APRV is a spontaneous ventilation mode with constant positive pressure on 2 different levels, during which the ventilator keeps the two pressure levels set constant.

In this operating mode the patient is free to breath spontaneously inside the circuit but at a pressure greater than the atmospheric one, with increased residual functional capacity. The clinician can set on the ventilator the pressure of the two levels and the relative times.

LOW LEVEL pressure - LOW level TIME

HIGH LEVEL pressure - HIGH level TIME

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During spontaneous breathing the pressure value varies around the set value, it tends to drop when the patient inhales and to rise when the patient exhales.

If during spontaneous breathing the patient does not reach the airway low pressure limit (LOW PAW), after 20 seconds the system activates the relative alarm.

In APRV the patient breaths on two positive pressure levels that are bot synchronised with the patient's spontaneous breathing.


If the patient stops breathing, after 20 seconds the system activates the low PAW acoustic and visual alarm (low airway low pressure).

4.7.12 MAN operating mode

MANUAL ventilation available in all operating modes.

By selecting the MAN mode using the encoder knob (at the bottom of the display) the system provides the patient with a breath.

The breath ventilation parameters depend on the set operating mode. The function activation is monitored by the GUI screen and signalled by the green LED inside the box, that turns on.

This mode is active while the lung ventilator is running.

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4.7.13 APNOEA BACK-UP

Apnoea BACK-UP is a safety function available in two of the operating modes: PSV and PSV-TV.

The apnoea BACK-UP function activates if the patient, ventilated in one of the modes above, stops breathing.

After a pre-set time (Apnoea Time) in the MAIN MENU - SETUP, will appear the relative alarms and the system automatically starts ventilating the patient.


When the ventilator switches to this safety mode automatically, the clinician CANNOT edit the ventilation parameters.

The ventilator continues its activity and the clinician acknowledges the emergency condition.

When the apnoea BACK-UP function activates, the ventilation parameters used are those set based on the selected operating mode.


To return to the initial ventilation conditions (operating modes, PSV and PSV-TV press the alarm silencing soft key.

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4.7.14 Physiological respiratory parameters ( PRP )

The physiological respiratory parameters must be set by the clinician in STAND-BY mode before activating the necessary operating mode.

The system allows you to set default PRP (Main Menu - DEFAULT PARAMETERS) suited for ventilating an adult patient.


Depending on the chosen ventilation mode, the same PRP can be a dependent variable (that varies depending on other parameters modification) or an independent variable (a value that if modified, affects the values of other parameters).

The PRP can also be adjusted while the ventilator runs, adapting them to the patient's clinical situation.

The parameters marked with BK refer to the BACK-UP operating mode.

RR BK (bpm) : Back-up respiratory rate, used when an apnoea condition arises to activate a controlled ventilation mode.

CPAP (cmH2O)

Continuous positive airway pressure during respiration phase.

Flow (L/min)

Flow value during inspiration

I:E

Ratio between inspiration and expiration phases.

RR (bpm)

Ventilator respiratory rate.

RRsimv (bpm)

Value of forced respiratory rate in SIMV mode.

O2 - He / O2

Oxigen concentration - Helios / Oxigen concentration

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Level 1 (cmH2O) - Level 2 (cmH2O)

Pressure levels to be set in APRV mode.

Pause (%)

Inspiratory pause time. The “inspiratory pause time” is displayed on the screen in % (% of the inspiratory time). It is also used to calculate the lung mechanics parameters (resistance and static compliance).

PEEP (cmH2O)

Positive airway pressure value during expiratory phase.

PLIM (cmH2O)

Maximum airway pressure limit value. The parameter is used in pressure controlled modes to fix an operating limit for the airway pressure that shall not be exceeded.

PMax (cmH2O)

Maximum airway pressure limit.

PS (cmH2O)

Positive airway support pressure value during inspiratory phase.

Sigh. Ampl. (%)

Sigh. Percentage increase of the set Vti.

Sigh. Int. (b)

Sigh. Activation frequency.

Ti (s)

Time that defines the ventilator inspiration duration. The values can be set based on the set RR.

Ti max (s)

Time that defines the maximum duration of an inspiration. If the duration of the inspiratory phase is lower than the set value, the patient will be forced to exhale.

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Time 1 (s) - Time 2 (s)

Duration of the two pressure levels set in APRV mode.

Tr. E (%)

Percentage of the inhaled flow with regard to the maximum peak where the inspiratory phase ends and the expiratory phase begins.

Tr. I (L/min) (cmH2O)

Flow level (pressure) for detecting the patient spontaneous breathing.

Vte (ml)

Expired tidal volume assured for the patient.

Vti (ml)

Inspired tidal volume assured for each breath.

4.7.15 Additional respiratory parameters

By selecting the GRAPHIC setup function using the encoder knob, the clinician can select and edit the curves, loops and additional parameters position.

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Mean airways pressure

It shows the average calculated pressure for the airways: the unit of measurement is cmH2O.

Pause pressure

It shows the pause pressure: the unit of measurement is cmH2O.

When the inspiratory pause activates, the ventilator maintains the airway pressure constant (it maintains a pause pressure) for a certain amount of time of the inspiratory time, defined by the clinician (INSP PAUSE %). The static conditions allow the ventilator to calculate the breathing mechanics parameters.

Inspiratory peak flow

Use the flow sensors installed on the inspiratory line to measure that maximum inhaled flow value (measured in l/min) and to view it on the screen. For this value there are no alarm limits but it can be used to gather information on the ventilation status.

Inspiratory time

It shows the duration of the patient's inspiratory phase: the unit of measurement is the second. This value represents the total inspiratory time, and also includes the inspiratory pause period.

This value depends on the respiratory rate and I:E ratio parameters. For example: if RATE = 15 and I:E=1:1 you will have an inspiratory phase of 2 seconds

Inspiratory pause

It shows the duration of the patient's inspiratory standby phase: the unit of measurement is the second. This parameter represents the inspiratory time during which the ventilator keeps the airway pressure constant.

Example: if RATE=15, I:E=1:1, Ppause=50% you will have an inspiratory pause period of 1 second.

Expiratory time

It shows the duration of the patient's expiratory phase: the unit of measurement is the second. This parameter defines the expiration duration. This value depends on the respiratory rate and I:E ratio parameters.

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Example: if RATE = 15 and I:E=1:1 you will have an expiratory phase of 2 seconds

Inspiratory resistance

It is the parameter of the lung mechanics that describes the resistance to the opposite flow of the airways: measured in cmH2O/(l/s). The greater the patient resistance, the higher the airway pressure you need to apply to obtain the same volume.

The formula used by the ventilator to calculate the inspiratory resistance is as follows:

Ri = (peak pressure – pause pressure) / inspired flow.

Static compliance

It is one of the two parameters of the lung mechanics: measured in ml/cmH2O. You can use it to asses the lung elasticity: the higher the compliance, the more elastic the “lung”; the lower the compliance, the more “rigid” the lung.

The static compliance can be calculated using the formula below:

CS = current inspired volume / pause pressure

Expiratory peak flow

Use the flow sensor installed on the expiratory line to measure the exhaled flow peak. At the beginning of the expiration, a flow peak arises in correspondence with the expiratory valve opening and it depends on the lung resistance and compliance

This measure, just like the previous one, is not related to specific alarms thresholds, it only provides information on the ventilation status.

For additional ventilation parameters monitoring please see 4.9.

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4.8 Ventilation phase

Before starting the ventilator you have to:

carry out all ventilator hardware connections (medical gases, power supply, patient circuit, ……..)

carry out the preliminary checks (please see chapter 3)

set the language and the patient data

set and check the alarms limits

set the physiological respiratory parameters and the operating mode that match the patient's clinical situation best.



Ventilator in STAND-BY mode

Press the START soft key to begin the ventilation in the selected mode with the most suitable PRP for the clinical situation of the patient.

To bring the ventilator in STAND-BY mode, please see 4.8.1 (next paragraph).

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In the upper section of the display you can find some values that will help you asses the patient's clinical condition.

In the main section you can see the curves that show the trend of the respiratory parameters.

On the right side of the screen there is a suitable lung icon that simulates the patient's lungs, graphically displaying the respiratory cycle by alternatively switching the lungs color.

The numerical value expressed in mH2O, placed above the lungs simulating icon, shows the depth reached inside the hyperbaric chamber.

Based on the physiological respiratory parameters set by the clinician according to the patient's characteristics, the lung ventilator is able to display and measure a series of values necessary for the patient's clinical evaluation.

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4.8.1 Ventilation interruption

Ventilator running

To interrupt the ventilation, hold the ON-OFF key for several seconds.

The system will ask you if you want to stop the ventilation (switch to STAND-BY mode).

Press ENTER to switch to STAND-BY mode.

Wait for a few seconds or press the ON/OFF key : the ventilator switches back to the previous condition, in the set ventilation mode.

Ventilator in STAND-BY mode

To stop the ventilator, hold the ON-OFF key for several seconds.

The system will ask whether to remain in STAND-BY or to shut down.

Press the ENTER key to turn the ventilator off.

Press the ON/OFF key : the ventilator returns to STAND-

BY.

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4.9 Graphical settings and operating functions

During the ventilation, the clinician can intervene using the graphical user interface, by selecting the options in the lower side on the screen.

Select the MENU function using the encoder knob to access the ventilator's MAIN MENU (please see 4.10) where you can find all the functions displayed in the figure.

Select the SET function using the encoder nob to access the ventilator operating mode setup and PRP configuration as you can see in the figure (please see 4.7).

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Select the GRAPHIC setup function using the encoder knob, to : select and edit the curves,

loops, and additional parameters position;

choose what loops and curves to view.

The graphical display function allows you to view the patient's data in real time, by means of:

curves: PAW (Pressure) / Time , Flow / Time , Volume / Time , CO2 (graphic not available)

loop : PAW (Pressure) / Current Volume , Current Volume / Flow , PAW (Pressure) / Flow

additional parameters table.

On the operator display there are:

4 areas (frames) for the additional parameters and curves;

1 area (frame) for loops positioning.

To change the combination of charts displayed on the screen, the ventilator must be on.

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Press the knob to highlight the first frame.

Turn the knob: the frames will be highlighted in sequence.

Press the knob to confirm the frame modification.

Turn the knob, the various types of curves will be displayed in sequence.

Press the knob to confirm your choice.

To return to ventilation view: press the ESC soft key;

wait for the system to return to ventilation screen automatically.

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Select the INSP HOLD mode and press the encoder knob: the system will extend the inspiration time up to 20 seconds.

The function activation is displayed by the GUI screen and signalled by the yellow LED inside the box, that turns on.

Select the EXP HOLD mode and press the encoder knob: the system will extend the expiration time up to 20 seconds.

The function activation is displayed by the GUI screen and signalled by the yellow LED inside the box, that turns on.

The clinician can enable both modes in sequence; the ventilator will carry out both modes, giving priority to the mode that was activated first.

INSP HOLD and EXP HOLD modes:

are deactivated automatically after 20 sec.

or by pressing the encoder knob.

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Select the NEB mode using the encoder knob to enable the nebulizer use. The lung ventilator provides a flow of 6 litres/min through the relative connector for a period of time equal to the inspiratory time.

The function activation is signalled by the green LED inside the box, that turns on.

During nebulizer use the ventilator maintains the oxygen concentration set. You can do this according to the current settings.

The NEB operating mode can be activated and deactivated manually using the encoder knob.

Select the function O2 100% using the encoder knob; the system will provide 100% oxygen concentration for 5 minutes (pre-set time).

After the pre-set time the systems automatically restores the previously set O2 concentration value.

The function activation is monitored by the GUI screen and signalled by the yellow LED inside the box, that turns on.

The O2 100% mode:

is deactivated automatically after 5 minutes or by pressing the encoder knob.

By selecting the MAN mode using the encoder knob (at the bottom of the display) the system provides the patient with a breath.

The breath ventilation parameters depend on the set operating mode. The function activation is monitored by the GUI screen and signalled by the green LED inside the box, that turns on.

This mode is active while the lung ventilator is running.

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4.10 MAIN MENU

By selecting the MENU function you can view the MAIN MENU page and set the functions necessary for proper ventilator operation.

Before using the lung ventilator for hyperbaric chamber Siaretron 1000 IPER, please use the MENU function to set all necessary items for proper ventilator operation.

Use the encoder knob to select the MENU box (the MENU box changes color)

Press the knob, on the display will appear the MAIN MENU.


The procedure for selecting an option from the MAIN MENU, implies using the encoder knob and the control keyboard as described herein (please see 2.4):

4.10.1 MAIN MENU - SETUP

To set the parameters in the SETUP option please see 4.11 SET-UP.

4.10.2 MAIN MENU - ALARMS

For ALARMS parameters and limits setup please see 5.2 ALARMS setup.

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4.10.3 MAIN MENU - TRENDS

Select the TRENDS function to monitor the most significant respiratory parameters on medium - long term.

The storage capacity for each parameter is 72 hours with sampling at every 4 minutes.

Use the encoder knob to select the TRENDS box (the TRENDS box changes color).

Press the knob, on the display will appear the page TRENDS.

The yellow arrow show the active work area.

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1. PRP curves (graphic), viewed in pairs

2. Vertical bar that shows the references movement in time

3. PRP, selectable in pairs

4. References over time on 72 hours with sampling at every 4 minutes

TRENDS view

Press the knob: the parameters screen activates

(turn the knob to choose the pair of parameters to monitor).

Press the knob: the vertical bar scrolling activates

(turn the nob to move the bar in time).

The parameters, that you can select in pairs using the encoder knob are:

the respiratory frequency or breaths - RR (bpm)

the airway pressure - PAW (cmH2O)

the positive expiration-end pressure - PEEP (cmH2O)

the expired minute volume - VM (L)

the expired current volume - Vte (ml).

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Editing TRENDS view.

The two yellow arrows show that the PRP area is active.

Press and turn the encoder knob: select the two parameters you want to monitor (e.g. Vm - PEEP).

Press the encoder knob: the two yellow arrows show that the Hours area is active (the vertical bar movement activates).

Turn the encoder knob, the vertical moves to the left of the screen.

At the same time the system updates the Date and Time (sampling every 4 minutes).

At the same time the system updates the values of the selected parameters (e.g. Vm - PEEP): the system displays the trend of the parameters values.

Press ESC to exit the TRENDS screen and go back to STAND-BY screen.


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4.10.4 MAIN MENU - EVENTS

Select the EVENTS function to monitor the information on the ventilator operation over time.

The monitored event refer mainly to the alarms (active alarms) and the various operating conditions of the lung ventilator (ON, OFF, STAND-BY).

The system can register up to 100 events, including the alarms.

Use the encoder knob to select the EVENTS box (the EVENTS box changes color).

Press the knob, on the display will appear the page EVENTS.

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1. Events time change indicator.

2. Event date [26.02.14] and time [16.11.00] indicator

3. Event description (white - red)

WHITE text : information on the ventilator operating status

RED text : information on event's alarms

EVENTS view

Turn the knob clockwise (anticlockwise) to view the EVENTS saved in the table.

Press ESC to exit the EVENTS screen and go back to STAND-BY.


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4.10.5 MAIN MENU - PATIENT DATA

To set the parameters in the patient data option please see 4.4 Setting the PATIENT DATA.

4.10.6 MAIN MENU - PATIENT DATA ERASE

To delete the patient data, please see 4.5 PATIENT DATA erase

4.10.7 MAIN MENU - DEFAULT PARAMETERS

Select the DEFAULT PARAMETERS function to restore the default parameters (factory-set).

By factory parameters we refer to all operation settings (MENU, SETUP, ALARMS limits, GUI colours).

Use the encoder knob to select the DEFAULT PARAMETERS box (the DEFAULT PARAMETERS box changes color).

Press the knob, on the display will appear the page DEFAULT PARAMETERS.

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Press the knob to restore the DEFAULT PARAMETERS.

Press ESC to exit the DEFAULT PARAMETERS screen and go back to STAND-BY.


4.10.8 MAIN MENU - CLOSE

Select the CLOSE option to exit the MAIN MENU and go back to STAND-BY view or to regular patient ventilation view.

If the clinician does not select any function in the MAIN MENU the system returns automatically to the previous display.

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4.11 MAIN MENU - SETUP

Select the MENU function to access the MAIN MENU screen and a series of functions such as SETUP, essential for setting up the ventilator operation.

Use the encoder knob to select the MENU box (the MENU box changes color).

Press the knob, on the display will appear the MAIN MENU at the option SETUP.


Press the knob, on the display will appear the SETUP screen at the option Language.

The yellow arrow shows that you can view other options by turning the knob.

The procedure for selecting an option from MAIN MENU – SETUP, implies using the encoder knob and the control keyboard as described herein (please see 2.4).

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4.11.1 SETUP options in MAIN MENU

Selection of the lung ventilator display language.

English, French, Spanish, Italian, German, etcc….

Selection of the type of graphic displayed during respiratory phase: Area or Line.

Line: The graphics line is traced without filling

Area: the graphics line is filled

Regulation of the alarm signal acoustic intensity: 1 - 30

Regulation of the machine power consumption percentage: 0-100.

Power saving mode that activates after 30 minutes, if no command is selected and the keyboard and encoder knob are not used

If set to 0, when activating this function, the display will show a black screen.

Regulation of the display brightness: 1 - 30

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Setting the time delay after which the APNOEA BACK-UP support function activates.

The time can be set from 5 to 60 sec.


Pay utmost attention when setting this parameter as its incorrect regulation might seriously affect the patient: we recommend you to set this value at about 20 seconds.

Function not available in the current HW version.

% : percentage

mmHg : milligrams of mercury

Selection of the displayed graphic unit of measurement CO2

Option NOT active

Turn the encoder knob to view the SETUP Settings below.

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Setting the data relative to contacts for technical leave, available on 6 different contact lines.

The methodology for the compilation of the text lines is similar to the description in section 4.4.1 PATIENT DATA setup.

Enabling the TEST ON DEMAND function.

The system shows the test available on the lung ventilator.

Before using the ventilator on a patient, you have to carry out a series of preliminary checks to make sure that it works properly.

Please see 3.5 for instructions regarding the TEST ON DEMAND function and how to use it.

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Configuration Registry 0

Configuration Registry 1

Sensor Status Registry

Errors Registry

Valid Data Registry

Adaptor Status Registry

Gas Sensor: Zero Calibration

Display of the gas analyser (sensor) operation.

The information displayed are purely informative and refer to the status and operation of the connected gas analyser; the same description is already mainly exhaustive and does not need any additional explanation.

The information in this parameter is dedicate to highly qualified staff, specifically trained and authorised by SIARE.

There are a series of parameters that allow the clinician to change the display colours.

Color of Parameters Values

Color of Parameters Names

Color of Parameters U.o.M.

Color of Parameters Box Border

Color of Parameters Box Background

Color of Small R.T. Box Border

Color of Small R.T. Box Background

Color of Big R.T. Box Border

Color of Big R.T. Box Background

Color of Big R.T. Value

Color of Small R.T. Value

Text of Status Bar

To restore the display pre-set colours, please see 4.10.7 MAIN MENU - DEFAULT PARAMETERS.

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If you select the CLOSE option, the system will switch to MAIN MENU.

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This page is intentionally left blank to ease the front / back copying process.

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5 ALARMS This chapter illustrates the part of the system relevant to the alarms operation of the Siaretron 1000 IPER ventilator for hyperbaric chamber (hereinafter called ventilator); also the operating logic and issues for alarms action are taken into consideration.

WARNING! Risk of injury for the user / patient

All the pictures and the examples shown in the present chapter have the mere purpose of being an example and they do not make any reference to real clinical cases.

WARNING! Risk of injury for the patient

Before using the ventilator, it is recommended to set the entries and the parameters referred to the alarms.

The ventilator is equipped with automatic means for detection and identification of serious and sudden events through alarm signals or information signals. The aim of the alarm signal is to draw the attention of the user on the event, as well as to indicate the required response speed.

Level or urgency

Immediate, the event is potentially able to develop in a period of time which generally is not enough to undertake a corrective manual action.

Brief, the event is potentially able to develop in a period of time which generally is enough to undertake a corrective manual action.

Delayed, i.e. that the event is potentially able to develop in a not specified period of time.

Level of severity

Severe, i.e. leading to irreversible damage.

Moderate, i.e. leading to reversible damage.

Minor, i.e. involving a distress or leading to a minor damage.

The combination of urgency level and severity level of the listed factors, determines the assignment of priority condition of an alarm situation.

The parameters and the characteristics (activation time, presence or lack of an acoustic and/or luminous indicator) and the possible user’s actions respect to the alarm signals (silencing, suspend, inhibit) are described here below.

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5.1 Displaying and used symbols

5.1.1 Alarms display area

A1 - Alarm area: this area of the monitor provides the following indications.

A string of text relevant to the type of active alarm.

An “alarm bell” symbol which indicates the priority and the alarm state.

A2 - ALARMS parameter, MAIN MENU

Through the encoder it is possible to select the entry of the ALARMS area – MAIN MENU to access the Min and Max. alarms value setting

A3 - General information signal area: this area of the monitor provides the following indications.

Battery charge level.

The main power presence (failure).

A4 - Soft key for acoustic alarm silencing

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5.1.2 A1 - Alarm area

This area shows the alarm type and the relevant priority/status of the same.

Alarms configurable by the user System alarms

Low / High Pressure

Low / High Frequency

Low / High Exp. Vte

Low / High Exp. VM

Low / High PEEP

Low / High FiO2

Power Failure

Apnea time

Low Battery 50% Rem.

Low Battery 25% Rem.

Low Battery 10 Min. Rem.

Battery Disconnected

Low O2 Supply

Low AIR Supply

Circuit Disconnected

Can-Bus Failure

Maintenance 1000 Hours (symbol which replace the alarm bell sign)

System signal: "MAINTENANCE 1000 HOURS". Once reached 1000 hours operation this symbol appears.

Contact the Siare Service Centre or a Centre authorized by Siare for preventive maintenance.

Symbol “alarm bell”

Medium priority: yellow bell Suspended alarm: yellow bell crossed through

High priority: red bell

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5.1.3 A2 - ALARMS parameter, MAIN MENU

This monitor area, through the encoder knob (ALARMS - MAIN MENU), allows to display and set the Min and Max. alarms values.

Low Pressure

High Pressure From 2 to 60 cmH2O

From 20 to 81 cmH2O

Low Frequency

High Frequency From 1 to 19 bpm

From 21 to 150 bpm

Low Exp. Vte

High Exp. Vte From 0 to 390 ml ( 10 ml steps )

From 1 to 3000 ml ( 10 ml steps )

Low Exp. VM

High Exp. VM

From 0 to 20 L

From 1 to 100 L

Low PEEP

High PEEP

From 0 to 19 cmH2O

From 1 to 51 cmH2O

Low FiO2

High FiO2

From 20 to 98 %

From 21 to 100 %

Power Supply Fault Enable / Disable

The ventilators used in the same health environments can have different preset configurations of alarm limits.

Verify that the preset alarm limits are appropriate for the new patient and adjust the alarm limits on values suitable to the new condition of use.

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5.1.4 A3 - General information area

This area shows the battery charge level and the electric power supply status (present/absent).

Green “BATTERY” symbol, indication of the battery charge level:

with fix symbol the battery is complete charge; with flashing symbol the battery is in charging phase.

Green “PLUG” symbol, indication of the main power supply presence.

Red “PLUG” symbol, flashing: indication of power failure.

The battery charge level is evidenced by the presence of coloured “notches” within the symbol, where each notch represents the 25% charging level.

Green flashing symbol, 2 notches: it indicates that the charge level of the battery is at 50% - the relevant alarm is active.

Orange flashing symbol, 2 notches: it indicates that the battery charge level is at 50% - the relevant alarm is active.

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Green flashing symbol, 1 notch: it indicates that the battery charge level is at 25% - the relevant alarm is active.

Red flashing symbol, 1 notch: it indicates that the battery charge level is at 25% - the relevant alarm is active.

The colour of the last flashing “notch” is red (high priority alarm): this extremely serious alarm condition indicates that the battery is almost completely low.

The green “PLUG” symbol: indication of the presence of main power supply.

Red colour signal, flashing: indication of main power failure.

The power failure alarm is reported both by the visual signals of the corresponding message in the alarm area and the high priority red bell.as well as by the flashing electrical power symbol.

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5.1.5 A4 - Acoustic alarm silencing

It’s possible to change the alarm settings even when the alarms are activated.

After changing an alarm setting, the relevant sign is lighted and the status icon will flash for a defined time.

The soft key, during the normal operating phase of ventilator, allows the silencing of active acoustic alarm.

WARNING! Risk of injury for the user / patient

The user should never stop checking the patient conditions during the alarm silencing.

Pushing the RESET button will stop the acoustic alarm for a defined time.

During the alarm silencing the alarm text is showed on the panel.

Pushing further the RESET button will cancel the alarm text only if the alarm conditions is disappeared.

If during the alarm silencing a new high priority alarm occur, the alarm silencing is cancelled and the acoustic signal and the visual texts are activated again.

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5.2 Alarms setting

5.2.1 Setting of ALARMS limits values.

Before using the ventilator it is suggested to use the MENU function to adjust the items necessary for the correct operation of the equipment.

During operation it is possible to adapt the alarm setting in function of the patient clinical situation.

Press the encoder knob, the SET function is activated.

Turn the encoder knob, select “MENU” , press the knob to confirm.

The “MAIN MENU” is displayed.

Turn the encoder knob clockwise to select the ALARMS function.

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Press the encoder to access to the parameters of ALARMS box.

Use the encoder knob to select the alarms and modify the preset values:

Turn clockwise (counter-clockwise) to select the alarm; press the encoder to access to the parameter modification.

Turn clockwise (counter-clockwise) to increase (decrease) the value of the parameter; press the knob to confirm the set value.

Turn clockwise (counter-clockwise) to select another alarm to be modified.

Press the ESC soft key to return to the MAIN MENU

Wait for the system to return automatically to the STAND-BY display

Press the ON-OFF key to return to STAND-BY display.

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5.2.2 Setting of ALARMS volume

The Volume parameter allows the adjustment of the volume of acoustic alarms signals at any priority level.

Press the encoder knob, the SET box is activated.

Turn the encoder knob, select “MENU”.

Press the knob to confirm; the “MAIN MENU” page is displayed.

Press the encoder to access to the displaying of SETUP page contents.

Turn the encoder knob clockwise to select the VOLUME box.

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Press the encoder knob to enable the box modification.

Turn the encoder knob clockwise (counter-clockwise) to modify the value of VOLUME parameter.

Press the encoder knob to confirm the modification of the VOLUME parameter value.

If it is necessary to modify the other parameters values, proceed as previously described:

Turn the encoder knob clockwise (counter-clockwise) to select another box of SETUP display;

Press the encoder to access to the modification.

Turn clockwise (counter-clockwise) to increase (decrease);

Press the knob to confirm.

Press the ESC soft key to return to the MAIN MENU

Wait for the system to return automatically to the STAND-BY display

Press ON-OFF key to return to STAND-BY display.

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5.2.3 Setting of DEFAULT values

The DEFAULT parameter allows setting the standard factory parameters.

Press the encoder knob, the SET function is activated

Turn the encoder knob, select “MENU” , press the knob to confirm.

The “MAIN MENU” page is displayed.

Turn clockwise the encoder knob to select the DEFAULT function.

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Press the encoder to access to the parameters of DEFAULT box.

To enter the standard factory parameters press the encoder knob.

In order not to modify the stored parameters press the ESC soft key and return to MAIN MENU display.

Wait for a few seconds, the system automatically returns to STAND-BY display.

Press the ON-OFF key to return to STAND-BY display.

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5.2.4 Alarms DEFAULT values

Low Pressure 5 cm H2O High Pressure 40 cm H2O

Low Frequency 5 bpm High Frequency 70 bpm

Low Exp. Vte 10 ml High Exp. Vte 1000 ml

Low Exp. VM 1 L High Exp. VM 12 L

Low PEEP 0 cm H2O High PEEP 20 cm H2O

Low FiO2 20 % High FiO2 100 %

Power Supply Fault Enable

Apnoea 20 sec.

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5.3 Troubleshooting

This chapter is an indicative but not exhaustive guide for the user and the technician, providing indications for eliminating, as quickly as possible, most of the problems that may have caused malfunctioning or alarm signals.

This chapter describes the possible causes of problems, indicated by alarms that are activated during normal functioning.

ATTENTION !! If the problem persists, carry out a complete check of the ventilator unit to identify any irregularities.

If the problem cannot be resolved, contact the Siare Service Centre or a Centre authorised by Siare.

Switch ON failure The unit does not switch on

Check that it is connected to the main power supply

Check that the main switch is turned to the I position (ON)

Check the main fuses

Contact the Siare Service Centre or a Centre authorised by Siare.

Power supply There is a power supply fault and the unit is operating on the battery

Check that it is connected to the main power supply

Check that the main switch is turned to the I position (ON)

Check the correct connections of the plug, the fuses and the connector, and the condition of the cable (if necessary, restore the connections and replace the cable if it is damaged).

Check that power is present at the relative socket by plugging in another electrical device. If there is no power, use another socket or check the overload switch on the electrical panel of the room.

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Initialization phase

The initialization phase is not completed and the system is blocked.

Verify and intervene in function on the error messages and indications evidenced during the “SELF TEST” phase.

Turn off and on the unit and repeat “SELF TEST” phase.


Soft keys and encoder knob

This condition occurs when the control keyboard or the Encoder are not working.

Switch the unit OFF and then switch back ON.


“CAN” bus error This alarm condition occurs in case of system failure (electronic boards).


Patient circuit disconnected

This alarm conditions occurs in case of pneumatic circuit malfunctioning.

Check that the alarm limits are set correctly.

Check that the mask, endotracheal tube and patient circuit are not in some way split, disconnected or connected wrongly If this is the case, eliminate the problem or replace them.

Check the correct settings of the patient's respiratory parameters (according to the operative mode selected: Volume/Flow, Rate, I/E, Trigger).

Check that the patient circuit is connected correctly to the unit and to the patient.


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Low O2 gas pressure

This alarm is activated when the pressure is insufficient (< 2.7 bar) for the unit to operate correctly.

Check that the medical gases are correctly connected to the unit. Restore the connections or replace the tubes if damaged.

Check that there is sufficient pressure in the supply system or in the cylinders. Adjust or repair the supply system (or replace the cylinders) if the pressure is insufficient.


Low AIR gas pressure

This alarm is activated when the pressure is insufficient (< 2.7 bar) for the unit to operate correctly.

Check that the medical gases are correctly connected to the unit. Restore the connections or replace the tubes if damaged.

Check that there is sufficient pressure in the supply system or in the cylinders. Adjust or repair the supply system (or replace the cylinders) if the pressure is insufficient.


Battery charge level 25% (50%)

This alarm is activated when the charge level of the battery is at 25% (50%) of the fully charged level.

Check that it is connected to the main power supply.

Recharge the battery.

If the alarm is activated when the battery has not provided the time autonomy indicated on the technical sheet, request the intervention of a Service Centre.

Low battery (10 minutes)

This alarm condition is present when the charge battery level is such to be guaranteed a residual autonomy of about 10 minutes.

Verify the correct connection of power supply.

To recharge the battery.

If the alarm is activated when the battery has not provided the time autonomy indicated on the technical sheet, request the intervention of a Service Centre.

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Exhausted O2

sensor The oxygen sensor is exhausted.

See information on FiO2 % low alarm

Replace the oxygen sensor with a new one.

If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare.

Disconnected O2

cell This alarm indicates the connection status of the oxygen sensor.

Check that the oxygen cell is correctly connected.

Replace the oxygen sensor with a new one.

Check the condition of the cable and the connector (if necessary, restore the connection and replace the cable if damaged).

If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare.

1000 working hours

This alarm condition occurs at overcoming of 1000 working hours from the last reset.

Contact the Siare Service Centre or a Centre authorised by Siare to execute the periodic scheduled revision.

FiO2 % high This alarm is activated when the measured concentration of oxygen exceeds the set limit.

Check that the corresponding alarm limits are set correctly.

Calibrate the oxygen cell: if the problem occurs again after a short time, replace the oxygen cell.


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FiO2 % low This alarm is activated when the measured concentration of oxygen is below the set limit.

Check that the oxygen cell is fitted correctly in its housing.


Calibrate the oxygen cell: if the problem occurs again after a short time, replace the oxygen cell.

Check that the feeding pressure of the medical gases is correct: if it is not, check the pressure of the distribution system and the correct connection to the supply.

Check that the mask, endotracheal tube and patient circuit are not in some way clogged, bent or crushed. If this is the case, eliminate the problem or replace them.


Min. expired volume

This alarm condition occurs in case the expired volume is lower than set value






If this is not the case, contact the Siare Service Centre or a Centre authorised by Siare.

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Max expired volume

This alarm condition occurs in case the expired volume is higher than set value




PAW high In this condition, the patient circuit + patient system presents a higher resistance than expected or a lower compliance. This causes an increase in airways pressure that exceeds the set limit.




Check that the luminous PAW bar on ventilator (the airways pressure curve) correctly follows the inspiration / expiration cycle.

Check that nothing is limiting the patient's respiratory capacity.


PAW low In this condition, the patient circuit + patient system presents a lower resistance than expected or a higher compliance. This causes insufficient ventilation pressure.




Check that the luminous PAW bar on ventilator (the airways pressure curve) correctly follows the inspiration / expiration cycle.


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Check that the unit delivers the gas mixture correctly.

Check that the low pressure level is higher than the PEEP level set. If not, increase it above the PEEP level.


Rate high This alarm is activated when the breathing rate value is higher than the set value.


Check that the patient's respiratory parameters are set correctly.

Check that the sensitivity of the Trigger is appropriate to the patient's physiological conditions.


Rate low This alarm is activated when the breathing rate value is lower than the set value.



Check that the unit operates correctly, checking the airways pressure trend. If the unit operates correctly, check the flow sensor and the correct connection of its cable.

Check that the mask, endotracheal tube and patient circuit are not in some way split, disconnected or connected wrongly if this is the case, eliminate the problem or replace them.




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Apnoea In this condition, no spontaneous respiratory activities is detected (RR = 0).




Check that the unit operates correctly, checking the airways pressure trend. If the unit operates correctly, check the flow sensor and the correct connection of its cable.



Calibration of flow sensor failed

The user can note indirectly, by monitoring the flow graph, the value of the expired volume and the peak value of expired flow, if the self-calibration of the flow sensor has been successful or not.


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6 MAINTENANCE

To guarantee the regular ventilator operation of the Siaretron 1000 IPER lung ventilator for hyperbaric chamber (hereinafter called ventilator), perform the following maintenance interventions with the recommended frequency.

All interventions must be conform to the practice and protocols in force in each facility.

The instructions for carrying out more detailed tests, for trouble-hooting and for other interventional procedures, information intended for qualified technical personnel, are contained in the relative chapter.

On completion of the maintenance operations, all removed components should be disposed of according to current waste disposal regulations: components that cannot be destroyed should be sterilized before disposal.

Follow current regulations for the disposal or recycling of all removed components.

WARNING!! Risk of injury for the user / patient

To ensure the safety of the patient and the operator, the ventilator must be inspected and checked when the limit of 1000 working hours has been reached or, in the event of limited use of the machine, at least every 6 months.

All maintenance and/or repair operations require perfect knowledge of the ventilator and must therefore only be carried out by highly qualified personnel, specifically trained and formally authorised by SIARE.

Inappropriate intervention or unauthorised modifications can compromise safety and cause danger to the patient.

To avoid the danger of electric shock during maintenance and/or repair operations, make sure that all power supplies have been disconnected, disconnect the power supply source (positioning the special danger signs) and disable the protection switch of the ventilator.

Before performing the maintenance or repairing works, also in case of returning the ventilator for repairing to manufacturer, it is required to clean and disinfect the ventilator.

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6.1 Cleaning, disinfection and sterilization

The operator is responsible for carrying out the ordinary maintenance as foreseen in this chapter.

Cleaning, disinfecting, sterilizing and replacement of parts must be carried out as indicated in this manual in order to avoid damage to the ventilator which could also endanger patient and operator safety.

WARNING!! Risk of personal injury

Do not attempt to dismantle, clean or rinse parts or components, such as the screen or knobs, with liquids or compressed air.

To avoid exposing the patient to sterilizing substances, these parts must be sterilized as described below. Remember that exposure to sterilizing substances can reduce the working life of some components.

Always use filters to protect circuits and ventilator: if foreseen, handle the filters with care to reduce the risks of bacterial contamination or material damage to a minimum.

Always respect the hospital procedures regarding the control of infections.

The ventilator does not require particular maintenance and preventive operations other than those indicated in this manual or in order to respect standards applied in the specific country where the ventilator is sold.

Siare is aware that working procedures can differ considerably from one health structure to another: it is therefore impossible to indicate specific procedures that are suitable for all requirements.

SIARE cannot be held responsible for the efficacy of the cleaning, disinfection and sterilization procedures, nor for the other procedures carried out while the patient is being treated.

This manual can only provide general instructions for cleaning, disinfection and sterilization. It is nevertheless the operator’s responsibility to ensure the validity and efficacy of the methods used.

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6.2 General indications

6.2.1 Cleaning

Use a disposable cloth moistened with neutral detergent, a chemical substance or the equivalent; use water to remove any traces of chemical.

Do not clean or re-use disposable products.

Do not use hard brushes to clean the components, or other instruments that could damage their surface.

Wash the components with hot water and a neutral detergent solution.

Rinse the parts well with clean hot water (tap water can be used) and leave to dry.

Siare recommends that the components should be checked every time they are cleaned and any damaged parts should be replaced.

Whenever a part or component is changed, check the functioning of the ventilator.

Follow the manufacturer’s instructions for the detergent substances used: the use of detergents that are too strong could compromise the working life of the components.

Deposits of detergent substances can cause damage or micro cracks, especially on parts exposed to high temperatures during sterilization.

6.2.2 Disinfection and sterilization

To disinfect the components, dismantle them and place them in a steam disinfection chamber at 93°C for 10 minutes.

After this first operation and before placing the components in an autoclave, wrap them in muslin or in a similar material.

Effective sterilization is achieved in an autoclave at 121°C for approx. 15 minutes.

WARNING!! Risk of injury for the patient

Always refer to the instructions provided by the autoclave manufacturer regarding temperature and time.

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Do not disinfect, sterilize or re-use disposable products.

Disinfect and sterilize every time an infected patient is ventilated.

In normal conditions, disinfect and sterilize according to how often the ventilator is used and in any case at least once a month.

Siare recommends:

that the components should be checked every time they are sterilized and any damaged parts should be replaced.

carrying out a functioning test of the machine whenever parts or components are replaced.

6.2.3 Disinfection by immersion (chemical)

If a steam disinfection chamber is not available, the dismantled parts can be chemically disinfected by means of immersion.

Immerse the dismantled components in the solution with the disinfectant, following the manufacturer’s instructions.

Siare recommends:

not using formaldehyde or phenol-based disinfectants as they can cause cracking and reticulation of plastic parts;

not using too strong disinfectants as they can compromise the working life of the immersed parts;

rinsing and carefully drying the components since marks and other damage can occur when the components are exposed to high temperatures.

When disinfection is complete, rinse with running, preferably decalcified, water; shake and drain off any remaining water. Leave the components to dry completely.

After this first operation and before placing the components in an autoclave, wrap them in muslin or in a similar material.

Effective sterilization is achieved in an autoclave at 121°C for approx. 15 minutes.

Always refer to the instructions provided by the autoclave manufacturer regarding temperature and time.

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6.2.4 Cleaning, disinfection and sterilization table

Component Procedure Notes

Outer casing Use a moistened disposable cloth with neutral detergent or a chemical substance or the like. Use water to remove any remaining traces of chemical.

The operator may use disinfectants (e.g. Buraton 10 F, diluted according to the manufacturer’s instructions or VPRO 60C°) to clean the components.

Disinfectants based on the following substances can cause damage:

halogen-releasing compounds; strong organic acids; oxygen-releasing compounds.

Remove any dust from the surfaces or in openings using a vacuum cleaner or a soft cloth.

Make sure that no sprays or liquids penetrate inside the equipment and the connectors.

Screen See above Do not use cloths or sponges that could scratch the surface.

To avoid damaging the labels and outer surfaces of the ventilator, use only the chemical substances listed.

Patient circuit (silicone tubes)

Dismantle and clean, then sterilize in an autoclave, disinfect with steam or chemically.

Before using again, eliminate any humidity inside the tubes by means of compressed air.

Check that there are no splits in the tubes and replace them if they are damaged.

Do not clean or re-use disposable circuit tubes.

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The patient circuit can be sterilized by means of steam but this can lead to early wear of the tubes.

Yellowing and reduced flexibility are side effects caused by sterilization using steam.

Do not clean or re-use if the filters are the disposable type. Components that cannot be destroyed should be sterilized and disinfected according to local standards.


It is necessary to have at least one spare patient circuit in stock for routine use and /or accidental breaks.

Couplings and connectors

Dismantle and clean, then sterilize in an autoclave, disinfect with steam or chemically.

Before using again, eliminate any humidity inside the components by means of compressed air.

Check that there are no splits and replace them if they are damaged.

EXP V. Monoblock

Disinfect with steam or chemically. It is possible to sterilize the component with gamma rays or ethylene oxide (ETO).

The EXP V. monoblock includes the expiratory valve and the flow sensor.

WARNING!! Risk of equipment failure.

Do not attempt to dismantle or clean with compressed air.

The EXP. V. monoblock can be washed and disinfected by immersing it in a bowl with 3 centimetres of liquid, keeping the connector for the electrical connections facing upwards.

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Mask Perform daily cleaning of the mask following the instructions of the responsible doctors or recommended by the Manufacturer.

Hang up the clean mask to provide that it is completely dry before use.

Always clean the mask and the hoses or use a new mask in case the lung ventilator must be used with a different patient.

If the lung ventilator is used with more than one patient in the clinic, insert an antibacterial filter between the patient outlet and the hose.

See Manufacturer’s instructions

Water trap filter

If reusable: clean, then sterilize in autoclave or chemically disinfect.

Check the presence of fissures and replace in case of damages.

Other accessories

Carefully follow the manufacturer’s instructions.

Refer to the accompanying documentation.

Electrical connections

On the aim to guarantee patient and operator safety it is necessary to keep the power supply cable in perfect conditions.

Perform daily checking’s of cable condition; any damage, also a minimum damage, must be promptly eliminated, eventually replacing the whole cable.

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6.2.5 Periodic maintenance

The lung ventilator does not require particular maintenance and preventive operations other than those indicated in this manual or in order to respect standards applied in the specific country where the ventilator is sold.

Inspections and periodic maintenance are ensured by taking out a maintenance contract with SIARE or an authorised dealer.

Contact SIARE for information regarding authorised Service Centres in your area.

When you require service, please indicate the serial number of the unit and the problem to SIARE or to your authorised technicians.

SIARE assumes responsibility for all provisions foreseen by the law, if the equipment is used and maintained as per the instructions in this manual and the technical manual

The Technical Assistance Report, signed by the authorised SIARE technician, is proof of the completion of the scheduled maintenance.

6.2.6 Maintenance operations


Always refer to the instructions contained in the previous section: cleaning, disinfection and sterilization of the components.

The table summarizes the preventive maintenance frequency and procedures to be carried out on the lung ventilator.

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Frequency Component Procedure / Action

Patient circuit Check for any water collection, drain and clean the tubes when necessary.

Filters Check for wear.

Several times a day / according to local practice and standards

Condensation trap filter

Check for any water collection, drain and clean when necessary.

Oxygen sensor Calibrate according to the procedures described in this manual.

Condensation trap filter

Check for any water collection, drain and clean when necessary.

Lung ventilator General cleaning and checks.

Every day / when necessary

EXP. V. monoblock Sterilize / disinfect according to the procedure described in this manual and according to local standards.

Ventilator The lung ventilator must be inspected and checked in general and any worn parts must be replaced.

Use the appropriate preventive maintenance kit.

This operation must only be carried out by qualified technical personnel, according to the instructions contained in the relative service and maintenance manual.

Oxygen sensor Replace. The working life of the cell depends on the working environment. If the temperature or the O2 % is high, the working life of the sensor will be lower.

Filters

Patient circuit

Every 6 months or 1000 working hours

Washers / O-Rings

Replace. Sterilize according to the procedure described in this manual and according to local standards.

Components that cannot be destroyed should be sterilized before disposal.

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Frequency Component Procedure / Action

Every year Lung Ventilator

Every years / when necessary

Internal battery

Check the performance.

This includes an electrical safety test and inspection of the ventilator for mechanical damage and legibility of the labels.

The lung ventilator must also be inspected and checked in general and worn parts must be replaced, using the appropriate preventive maintenance kit.

These operations must only be carried out by qualified technical personnel, according to the instructions contained in the relative service and maintenance manual.

Every two years / when necessary

Internal battery Replace.

This operation must only be carried out by qualified technical personnel, according to the instructions contained in the relative service and maintenance manual.

The working life of the battery depends on the working conditions and environment.

To avoid damage to components due to excessive wear, carry out preventive maintenance and replace parts following the recommended frequency.

6.2.7 Cleaning, disinfection and sterilization before use with another patient

We recommend the use of procedures for sterilization and disinfection referred to in the preceding paragraphs when a new patient must use the lung ventilator.

WARNING !! Risk of injury for the patient

It is recommended to sterilize / disinfect the ventilator lung every time is used with another patient.

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6.3 Repairs and spare parts

Use only original SIARE spare parts or spare parts checked and approved by SIARE.

6.3.1 Spare parts kit for lung ventilator

Code : R033000A1

Spare parts kit for annual maintenance to be used with the Siaretron 1000 IPER.

Code : R033000CL

Battery kit to be used with the Siaretron 1000 IPER.

6.4 Storage

If for any reason the lung ventilator is not used, we suggest leaving it in its original packaging and storing it in a safe and dry place.

If it is believed that the lung ventilator will be left unused for at least 6 months, Siare recommends disconnecting the battery or recharging it every 3/6 months, depending on the storage temperature.

See the technical sheet in the Appendix A.

6.5 Repackaging and shipment

If it is necessary to return the equipment to SIARE for any reason, we suggest using the original packaging to prevent damage to the equipment during shipment.

If this is no longer available, order a repackaging kit.

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6.6 Disposal

Batteries, accumulators, oxygen cells and electronic parts in general:

do not put them in the fire, explosion risk

do not open them, corrosion danger

do not recharge batteries

do not throw them away with normal waste.

The batteries and the accumulators are special waste materials and they must be disposed of in appropriate containers in accordance with local regulations for the disposal of such waste materials.

The components of the electronic boards can contain compounds, such as arsenic, lead, cadmium, mutagenic and cancerogenous agents, that are a health hazard if dispersed in the environment in an uncontrolled way.

For further information contact the relevant authorities for environmental and public health monitoring.

256

Siaretron 1000 IPER A-1

A APPENDIX This chapter includes all the information and data necessary to provide full knowledge and

interpretation of the Siaretron 1000 IPER ventilator for hyperbaric chamber (hereinafter called ventilator).

A.1 Technical sheet

GENERAL DATA

Main characteristics The Siaretron 1000 IPER lung ventilator has been designed to work in hyperbaric chamber up to 60m depth.

The Siaretron 1000 IPER is equipped with a TFT 9” colour monitor displaying the curves of pressure, flow, volume, the loops of breathing parameters, the trends and the ventilation parameters.

The Siaretron 1000 IPER is suitable for ventilation of adult, paediatric and neonatal patients. It is equipped with a flow and pressure trigger, it provides the most advanced volume controlled ventilation modalities (VC/VAC, VC/VAC-BABY), pressure controlled ventilation modalities (APCV, APCV-TV), SIMV by Volume and by Pressure, Pressure supported modalities (PSV, PSV-TV), CPAP, BILEVEL S-ST, SIGH, Non Invasive Ventilation (NIV), Drug Nebulizer and Manual Ventilation (MAN).

Siaretron 1000 IPER is supplied with back up long lasting batteries and its software can be updated for new modes and last generation ventilatory strategies.

NORMS

0476 The lung ventilator is conform to the essential requirements and it is realized according to the references of the Annex II of 93/42/EEC Medical Devices Directive.

Class and type according to IEC 601-1

Class 1 Type B

Class according to 93/42 EEC Directive

Class IIb

Electromagnetic compatibility (EMC)

Conform to the requirements of the IEC 601-1-2 norm.

Norms IEC 601-1 , IEC 601-1-1 , IEC 601-1-2 , IEC 601-1-4 , IEC 601-1-8 , IEC 601-2-12 , EN 1281-1 , UNI EN 4135.

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A-2 User manual, DU3069100 / rev. - 02.09.2014

ENVIRONMENTAL CONDITIONS

Operating Relative humidity : 30 - 95% non-condensing

Temperature : from +10 to +40°C

Storage Relative humidity : < 95%

Temperature : from -10 to +60°C

TECHNICAL DATA

Dimensions (W x H x D) 266 x 251 x 182 mm

Weight 5.5 Kg

Flow compensation up to 60m depth

Automatic

Flow compensation with HELIOX

Automatic

Electric power supply 100 ÷ 240Vac / 50 ÷ 60Hz / 2,4A (for usage outside hyperbaric chamber)

Electric power supply (low tension)

12Vcc / 4,2A (for usage inside hyperbaric chamber)

Power 55 Watt

Internal power supply 12 Vdc / 4,5Ah

Internal battery operation 120 minutes max.

Battery re-charging time About 8 hours

Patient connections Male conic connectors 22 mm / Female of 15 mm (according to EN 1281-1 norm)

Gas supply (O2 – Aria) Pressure included between 280 kPa - 600 kPa / 2,8-6 bar / 40-86 psi

Max flow requested 120 l/min (for each gas inlet)

LUNG VENTILATOR FUNCTIONAL FEATURES

Use destination Ventilator for Intensive Therapy for adults, children and newborns.

Operation principle Time cycled at constant volume

Pressure cycled

Microprocessor controlled flow

Spontaneous breath with integrated valve

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Automatic compensation of atmospheric pressure

Automatic compensation of atmospheric pressure on measured pressure: available

Dead space compensation

Automatic compensation of mechanical and patient circuit dead space

Automatic leaks compensation

Present (with FLOW parameter set in AUTO) in NIV modalities

Ventilation modalities APCV (BILEVEL ST), APCV-TV, PSV (BILEVEL S), PSV-TV (AutoWeaning), VC/VAC, VC/VAC BABY, V SIMV+PS, P SIMV+PSSPONT, CPAP, APRV

SIGH, NEB, Apnoea BACK-UP, NIV, MANUAL.

Breathing rate VC/VAC From 4 to 150 rpm

Inspiratory Time; Expiratory Time (maximum, minimum)

Ti min = 0.036 sec. (minimum inspiratory time)

Ti max = 9.6 sec. (maximum inspiratory time)

Te min = 0.08 sec. (minimum expiratory time)

Te max = 10,9 sec. (maximum expiratory time)

Breathing rate V-SIMV e P-SIMV

From 1 to 60 bpm

SIMV Inspiratory time From 0.2 to 5.0 sec.

Tidal volume from 2 to 3000 ml (from 2 to 100 ml in VC/VAC BABY mode)

I:E ratio From 1:10 to 4:1

Inspiratory pause From 0 to 60 % of the inspiratory time

Inspiratory pressure limit (PLIM)

From 2 to 80 cmH2O (in function of low and high pressure alarm set)

PEEP From OFF, 1 to 50 cmH2O

PEEP adjustment Microprocessor controlled valve

O2 concentration Adjustable from 21 to 100% with electronic integrated mixer.

Automatic safety function to decrease O2 concentration for depth greater than 2.2bar (O2=50%) or greater than 5bar (O2=21%).

Trigger detective method Through sensor (pressure or flow)

Pressure trigger By adjustable pressure from OFF; -1 to -20 cmH2O under PEEP level from -1 cmH2O to -20 cmH2O : step of 1 cmH2O

259


Flow trigger Flow adjustable from OFF; 0.3 to 15 L/min from 0,3 to 1 L/min: step of 0,1 L/min

from 1 L/min to 2 L/min : step of 0,5 L/min

from 2 L/min to 15 L/min : step of 1 L/min

Trigger E From 5 to 90 % of the inspiratory flow peak

Inspiratory flow (FLOW) 120 l/min per every gas (240 L/min max.)

Flow-by 2 l/min + Flow Trigger

PS (pressure support) From 2 to 80 cmH2O (PSV - V SIMV+PS, V SIMV+PS)

SIGH in VC/VAC modality Interval : 40 ÷ 500 bpm (step 1 bpm)

Amplitude : OFF, 10 ÷ 100% of set Tidal Volume (step 10%)

CPAP From 3 to 50 cmH2O

APRV Time 1 and Time 2 : from 10 to 200 sec.

Level 1 and Level 2 : from 3 to 50 cmH2O.

Other controls MENU function, SET function

Function to select Loops, Curves, Parameters’ Map displaying

INSP Block and EXP Block (max. 20 seconds)

NEB control

O2 100% (O2 al 100% max. 5 min) control

MAN control (manual ventilation)

NEB Drug nebulizer: selectable to 6 l/min with automatic compensation on forced ventilation modes and dedicated output

Patient circuit Double-hose, non re-breathing

Expandability Software upgradeable for future modalities

USER INTERFACE

Monitor Module with TFT display

Dimensions 9”

Displaying area 184x140 mm

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Display keyboard Lateral keyboard for rapid access of functions. Encoder knob for:

selection, set up and confirmation of physiological breathing parameters

selection and direct activation of function

Displaying and settings Setting of Operative Mode

Visualization of alarm messages and signals

Setting and monitoring of physiological breathing parameters

Visualization of additional graphs and breathing parameters

The function MENU for setting operation parameters

Activation of special functions

Visualization of operative mode, clock, date and time functions

Visualization of software version

MENU function SETUP adjustments

Alarms

Trends

Events

Patient data

Default parameters

SETUP function (settings) Language

Graphic

Volume

Energy saving

Brightness

Apnoea time

Gas sensor N2O : unit of measurement

Password

TCP setting

Technical contact

Test on demand

Gas sensor

Colour selection

Trends Storage capacity (72 h) of all measured parameters.

Events Memory storage up to 100 machine events including the alarms.

Patient data The patient data can be set and cancelled

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Default parameters The default parameters can be restored

SETTING function (set of physiological breathing parameters)

FLOW (L/min), FR (bpm), FRsimv (bpm), I:E, Pause (%), PEEP

(cmH2O), PLIM (cmH2O), PMax (cmH2O), PS (cmH2O), SIMV RATE

(bpm), Ti (s), Ti max (s), Ti min (s), Trig. E (%), Trig. I (L/min), Vte (ml),

Vti (ml), O2 (%), SIGH (% - bpm), CPAP (cmH2O), APRV (sec. -

cmH2O ), BACK-UP parameters

Range of measured parameters

PAW: peak, mean, plateau, PEEP (range -20 ÷ 80 cmH2O)

Tinsp., Texp, Tpause (range 0.036 ÷ 10,9 sec)

I:E ratio (range 1:99 ÷ 99:1)

Static and dynamic compliance (range: 10 ÷ 150 ml/cmH2O)

Resistance (range: 0 ÷ 400 cmH2O/l/s)

% of FiO2 (range: 0% ÷ 100%)

Rate (range: 0 ÷ 150 bpm)

Tidal Volume: Vte, Vti (range: 0 ÷ 3000 ml)

Minute Volume (range: 0 ÷ 40 l/min)

Inspiratory Peak Flow (range: 1 ÷ 240 l/min)

Expiratory Peak Flow (range: 1 ÷ 150 l/min )

Depth (range: 0 ÷ 60 mH2O )

Displayed parameters FR (bpm), I:E, FiO2 (%), Vt (ml), VM (L/min), PAW (cmH2O), PEEP (cmH2O)

Additional displayed parameters

MAP (cmH2O), Pplateau (cmH2O), Fi (L/min), Fe (L/min), Ti (sec.), Te (sec.)

Tpause (sec.), Ri (cmH2O/L/sec.), Cs (ml/cmH2O)

Displayed graphics CURVES: Pressure - Flow - Volume

LOOPS : Pressure / Volume - Flow / Volume - Pressure/Flow

Auto range

Flow sensor Magnetic disturbance (patented), multi-usage type

Calibration Automatic (started by the operator)

Maintenance By steam or chemical disinfection

Oxymeter Electronic (value displayed in breathing parameters)

Calibration Automatic (started by the operator)

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ALARMS

Alarm types By MENU: with limits set by the operator

By default: the operator cannot set them up

Alarm priority High - Mean - Standby

Alarms with limits set up by the operator

Airways pressure High – Low

Breathing rate High – Low

Expired Minute Volume High – Low

Expired Tidal Volume High – Low

FiO2 concentration High – Low

PEEP High – Low

Electric power supply Alarm occurs in case of failure of external power supply

Apnoea Low Rate (function of Apnoea BACK-UP)

System alarms

Level (charge) Battery at 50%

Level (charge) Battery at 25%

Battery Level (low) 10 Minutes

Disconnected Battery Yes / No

Gas feeding: O2 Low (< 2,7 bar)

Gas feeding: Air Low (< 2,7 bar)

CAN BUS error Electronic boards CAN connection wrong

Maintenance 1000 hours

SELF-TEST alarms

Gas supply Verification of the presence of Air and O2 supply pressure

EXP.- INSP. Flow sensor Verification of EXP flow sensor operation

Airways pressure sensor Verification of pressure sensor operation through control of PAW reading

Patient circuit Verification of patient circuit

Battery Checking on battery power

263


Oxygen cell Cell condition

Acoustic alarm Verification by the user of acoustic signal emission, the confirmation of the test is made by silencing of that alarm

ACCESSORIES

Supplied Accessories

User's Manual

O2 supply hose

AIR supply hose

Nebulizer set

Coaxial patient circuit

Antibacterial filter

Power cable

SIARE M20 O2 cell

Optional Accessories See on Export Price List

264


A.2 Pneumatic drawing

265


A.3 Preliminary checks

See the table here below:

List of preliminary checks:

REF. DESCRIPTION MEASURE RESULT NOTES

1. ON/OFF SWITCH Pos. Neg.

2. SELF TEST overcome Pos. Neg.

3. O2 sensor calibration (TEST) _____ % Pos. Neg.

4. O2 - FiO2 alarm check Pos. Neg.

5. Patient circuit leak (TEST) Leak _____ Pos. Neg.

OPERATIVE MODE : VC-VAC / PARAMETERS MONITORING

6. Vti check: 500mv Pos. Neg.

7. Rate check: 15 Pos. Neg.

8. I:E ratio check: 1:2 Pos. Neg.

9. PEEP check: (5 – 10 cmH2O) Pos. Neg.

10. PAUSE check: 50 % Pos. Neg.

11. FiO2 check: 21% Pos. Neg.

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ALARM CHECKS

12. High / Low Pressure Pos. Neg.

13. High / Low Frequency Pos. Neg.

14. High / Low Expired Vte Pos. Neg.

15. High / Low Volume Minuto Pos. Neg.

16. High / Low airways PEEP Pos. Neg.

17. High / Low oxygen concentration Pos. Neg.

18. Main power failure Pos. Neg.

19. Gas supply failure Pos. Neg.

20.

RESPIRATORY PARAMETERS CHECKS 21. Pmax Check Pos. Neg.

22. Peep Check Pos. Neg.

23. Rate Check Pos. Neg.

24. I:E Check Pos. Neg.

25. O2 Check Pos. Neg.

26. Vte Check Pos. Neg.

27. VM Check Pos. Neg.

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A.4 Table for Identification of medical gas hose colours

GAS SYMBOL ISO & UK USA GERMANY

OXYGEN O2 White Green Blue

NITROUS OXIDE N2O Blue Blue Grey

CARBON DIOXIDE

CO2 Grey Grey -

CYCLOPROPANE C3H6 Orange Orange -

MEDICAL AIR AIR White & Black Yellow Yellow

ENTONOX 50/50 N2O/O2

N2O + O2 Blue & White - -

EMPTY - Yellow - -

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A.5 Glossary

A Ampere (current intensity measurement unit)

Alarm message A message which appears together with an alarm indication; this consists of a basic message indicating the type of alarm.

Alarm silencing or suspension key

Key that stops the acoustic alarm signal for a software value preset by the last pressing of the key.

APCV Pressure controlled ventilation: type of controlled ventilation during which the ventilator delivers an inspiratory pressure set by the user for an inspiratory time also set by the user.

Apnoea End of ventilation. The ventilation system indicates apnea and starts the corresponding ventilation when the interval between the two respiratory cycles exceeds the set apnoea time.

Automatic alarm resetting

This occurs when an alarm is disabled, i.e. when the alarm conditions are no longer present, without pressing the alarm reset key. ALARM RESET

Basic flow Constant flow (depending on the sensitivity value set in the “trigger value” parameter) circulating in the patient circuit with respect to which the ventilator measures the Flow Trigger value.

CE A certificate of origin issued by the European Economic Community indicating that the equipment conforms to the Medical Device Directive (MDD), 93/42/EEC.

Clinical alarm An alarm that can indicate an abnormal physiological condition

cm Centimetre (unit of length).

cmH2O Centimetres of water (unit of pressure = 0.98068 mbar = 1 hPa).

Compliance (Cs) This term defines the variation in volume of the respiratory tract determined by a variation in pressure; it is measured in ml/cmH2O. It provides an indication of the elastic properties of the respiratory system and its components (Inspiratory Tidal Volume / Pause Pressure).

Compressor The Compressor (optional) provides the system with compressed air and can be used instead of the mains or cylinder supply of compressed air.

CPU Central processing unit

DISS Diameter Index Safety Standard: a standard for high pressure gas input connectors.

EMC Electromagnetic Compatibility

EN European norm referring to the European Economic Community

EPU Electric power supply unit: the battery powers the system with direct current if the alternate current supply is not available. On the basis of the ventilator settings, the battery can provide back-up power for at least 3 hours in rated and perfect working conditions.

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Error Category of conditions detected during functioning of the system implying an open safety status. A fan FAILURE means that the fan cannot be clinically used and must be repaired immediately.

EXP. PAUSE Expiratory pause, a manoeuvre started by the operator which closes the inspiratory and expiratory valves during the expiratory phase of a breath.

FiO2 Parameter set by the operator and monitored. The % setting of FiO2 determines the percentage of oxygen in the gas delivered to the patient. The monitored data of the % of FiO2 indicate the percentage of oxygen delivered to the patient, measured on the inspiratory line.

Flow Trigger Method of recognition of the inspiratory effort of the patient, during which the ventilator controls the basic flow circulating in the patient circuit. An inspiratory attempt by the patient is translated into a decrease of the basic flow, which the ventilator recognizes as a spontaneous breath and delivers a synchronized breath.

GUI Graphics user interface, the part of the ventilator which comprises the screen, the keys and the knob. The GUI is equipped with an independent CPU which monitors the data of the ventilator and the patient. The screen displays the monitored information, including the alarms, the monitored parameters, the graphs, the ventilator settings and the messages.

High priority alarm As defined by the international standards organizations, this is an alarm which requires immediate intervention to ensure the safety of the patient. During a high priority alarm, the corresponding red signal flashes rapidly, a high priority acoustic alarm signal is emitted (a series of five tones repeated twice, followed by a pause, then repeated again) and an alarm message is displayed in the upper part of the screen.

hPa Hectopascal (unit of pressure, approximately equal to 1 cmH2O).

Hz Hertz (unit of measurement of frequency, indicating cycles per second).

I:E ratio The ratio between inspiratory time and expiratory time

IEC International Electro-technical Commission: international organisation for the definition of standards.

INSP. PAUSE Inspiratory pause, a manoeuvre started by the operator which closes the inspiratory and expiratory valves during the inspiratory phase of a breath. This manoeuvre can be used to determine the static compliance (C) and the resistance (R).

IPPV Intermittent Positive Pressure Ventilation

IPPV - AST Assisted Intermittent Positive Pressure Ventilation: a ventilation mode that makes it possible to deliver only controlled ventilation (started by the patient, the ventilator or the operator) on the basis of the current settings.

ISO International Standards Organization

kg Kilogramme (unit of weight).

L Litre (unit of volume).

L/min Litres per minute (unit of flow).

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Loop Parameter-based curve with respect to time

Low priority alarms As defined by the international standards organizations, this is an alarm that indicates a change in the patient-ventilator system. During a low priority alarm, the corresponding yellow signal lights up and an alarm message is displayed in the upper part of the screen.

m Metre (unit of length).

Maintenance All the operations necessary to maintain the equipment in working order or to carry out cleaning, maintenance, repairs, modifications, revisions and performance checks.

MAN If the MANUAL key is pressed in PSV mode, the system delivers pressure controlled ventilation to the patient.

MAP Indication of the mean airways pressure

Medium priority alarm As defined by the international standards organizations, this is an abnormal condition which requires immediate intervention to ensure the safety of the patient. During a medium priority alarm, the corresponding yellow signal flashes. A medium priority acoustic alarm signal is emitted (a repeated series of three tones) and an alarm message is displayed in the upper part of the screen.

min Minute (unit of time).

Minute volume Expired tidal volume normalized to the unit of time (L/min). The system estimates the total minute volume on a 60 second basis or on previous ventilations, whichever is the shorter. The value displayed includes the compensation for compliance.

mL Millilitre (unit of volume).

Mode Ventilation mode; an algorithm which determines the type and sequence of ventilation: the system offers a series of possible choices, including assisted, spontaneous or synchronized ventilation.

ms Millisecond (unit of time).

NIST Non-interchangeable screw thread: standard for high pressure gas inlet connectors.

Patient circuit All the inspiratory-expiratory conduits, including the tubes, the humidifier and the filters (when foreseen).

PAW Measured airways pressure

PCV Pressure controlled ventilation: a type of controlled ventilation during which the ventilator delivers an inspiratory pressure set by the operator for an inspiratory time also set by the operator.

PEEP Positive end expiratory pressure: the minimum level of pressure maintained in the patient circuit during ventilation. Parameter set by the operator and monitored.

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Pressure Trigger Method of recognition of the inspiratory effort of the patient, in which the ventilator controls the pressure in the patient circuit. The ventilator enables ventilation when the airways pressure decreases by an amount at least equal to the selected threshold value in a defined period of time.

PSV Pressure support ventilation: a type of spontaneous ventilation in which the ventilator delivers pressure set by the operator during the inspiratory phase.

RAM Random access memory

Resistance (Ri) The drop in pressure caused by a flow passing through a conduit: measured in cmH2O/(litres/sec) or hPa/(litres/sec).(peak pressure - pause pressure / inspiratory flow).

sec Second (unit of time).

SIMV+PS Synchronized Intermitted Mandatory Volumetric ventilation with spontaneous ventilation by pressure support.

SPONT In SPONT mode, the patient activates all ventilations delivered by ventilator without any controlled respiratory rate set. The patient makes spontaneous breaths by pressure support.

STANDBY Ventilation system in pause status: no ventilation is enabled when the ventilator is in this status.

System error Definition used by the safety system of the ventilator. System errors include faults of the hardware inside the ventilator and which affect its performance, software errors which occur momentarily inside the ventilator and interfere with its normal functioning, an inadequate supply of alternate current or gas and the problems of integrity of the patient circuit (block or disconnection). In general system errors are not corrected automatically

T Exp Expiratory time: duration of the expiratory interval of a breath.

T Insp Inspiratory time: duration of the inspiratory interval of a breath.

T pause Pause time: percentage of inspiratory time during which the ventilator maintains a constant airways pressure. Used for calculation of the respiratory mechanics parameters (compliance and resistance).

Tidal volume Inspired and expired tidal volume during each breath. The value delivered by the system is a parameter set by the operator which determines the volume delivered to the patient during controlled volume ventilation. Tidal volume includes the compensation for compliance and for pressure and body temperature.

TREND Medium and long-term monitoring of the respiratory parameters.

VA Volt -Ampere (unit of power).

Vac Alternate current voltage

VC-VAC Intermitted ventilation by assisted positive pressure: a ventilation mode which allows to deliver controlled ventilations only (started by the patient, by the ventilator or by operator) basing on current settings.

272


Vdc Direct current voltage

Ventilations per minute (bpm)

Respiratory rate unit (Resp/min).

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A.6 Electromagnetic compatibility tables

A.6.1 ANNEX A: Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

The Siaretron 1000 IPER is intended for use in the electromagnetic environment specified below. The customer or the user of the Siaretron 1000 IPER should assure that it is used in such an environment.

Emissions test Compliance Virdict Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1 Compliance

The Siaretron 1000 IPER uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class A Compliance

Harmonic emissions IEC 61000-3-2 Class A Class A, B, C, D, o

NOT APPLICABLE

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Compliance Compliance

The Siaretron 1000 IPER is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning. This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Siaretron 1000 IPER or shielding the location.

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A.6.2 ANNEX B: Table 2

Guidance and manufacturer’s declaration - electromagnetic immunity


IMMUNITY test IEC 60601 test level Compliance level / Verdict Electromagnetic

environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

6 Kv contact

8 kV air

6 kV contact

8 kV air Residential - Hospital - Other

Electrical fast transient/burst IEC 61000-4-4

2 kV for power supply lines

1 kV for input/output lines

2 kV for power supply lines

1 kV for input/output lines

Residential - Hospital - Other

Surge IEC 61000-4-5 1 kV line(s) toline(s)

2 kV line(s) to earth

1 kV line(s) to line(s)

2 kV line(s) to earth


Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT)

for 5 cycles

70 % UT (30 % dip in UT)

for 25 cycles

<5 % UT (>95 % dip in UT)

for 5 s

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT)

for 5 cycles

70 % UT (30 % dip in UT)

for 25 cycles

<5 % UT (>95 % dip in UT)

for 5 s


Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Residential – Hospital – Other

NOTE UT is the a.c. mains voltage prior to application of the test level.

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A.6.3 ANNEX C: Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity


IMMUNITY test IEC 60601 TEST LEVEL

Compliance level effective

Compliance level

Electromagnetic environment – guidance

Recommended separation distances

3 Vrms 150 kHz to 80 MHz outside ISM bands

VRMS [V1] VRMS SEE ANNEX E

Conducted RF IEC 61000-4-6

10 Vrms 150 kHz to 80 MHz in ISM bands

VRMS [V2] VRMS SEE ANNEX E

80 800 MHz

SEE ANNEX E Radiated RF IEC 61000-4-3

10 V/m 80 MHz to 2,5 GHz V/m [E1] V/m

800 2500 MHz

SEE ANNEX E

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note:

1. At 80 MHz and 800 MHz, the higher frequency range applies.

2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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A.6.4 ANNEX E: Table 5

Recommended separation distances between portable and mobile RF communications equipment and the Siaretron 1000 IPER

The Siaretron 1000 IPER is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Siaretron 1000 IPER can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Siaretron 1000 IPER as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m Rated maximum output power of

transmitter

W

150 kHz 80 MHz outside ISM bands

PV

d

1

5,3

150 kHz 80 MHz in ISM bands

PV

d

2

12

80 MHz 800 MHz

PE

d

1

12

800 MHz 2,5 GHz

PE

d

1

23

0,01 0,12 0,12 0,12 0,23

0,1 0,37 0,38 0,38 0,73

1 1,17 1,20 1,20 2,30

10 3,69 3,79 3,79 7,27

100 11,67 12,00 12,00 23,00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note : 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

2. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

3. An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

Note: the values shown in the table refer to the standard levels of the norm, 3V for V1 and 10V for V2

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This page has been added to make front / back copy easier.

278

Siaretron 1000 IPER

Lung ventilator

for Hyperbaric chambers

User’s Manual

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore, 18

Località Crespellano, 40053 Valsamoggia (BO), ITALY

Tel.: +39 051 969802 - Fax: +39 051 969366

E-mail: [email protected]

Web: www.siare.it

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14.2.9.4 Oxygen Monitoring.

14.2.9.4.1

Oxygen levels shall be continuously monitored in any chamber in which nitrogen air or other diluent gas is added to compress the chamber orto reduce the volumetric concentration of oxygen in the atmosphere.

14.2.9.4.1.1

Oxygen monitors shall be equipped with audible and visual alarms.

14.2.9.4.2

Oxygen levels shall be continuously monitored in Class A chambers when breathing mixtures containing in excess of 21 percent oxygen byvolume are being breathed by patients or attendants or any flammable agents are present in the chamber, or when either of these conditionsexists.

14.2.9.4.2.1

Audible and visual alarms shall indicate volumetric oxygen concentrations in excess of that are outside of the 19 - 23.5 percent range for ClassA chambers and less than 95 percent for Class B chambers .

14.2.9.4.2.2*

Oxygen levels in Class A chambers shall be sampled from at least two sample ports at disparate locations of the chamber and shall have aseparate oxygen monitor for each sample port.

14.2.9.4.2.3*

Sample response time, at all treatment levels, shall be no more than 10 seconds.

14.2.9.4.2.4*

At least one sample port shall be equipped with a removable extension to allow for spot checking of any location within the chamber.


14.2.9.4.1 Changing the wording from nitrogen to air is intended to increase the safety standard for chambers that can be compressed with oxygen or air. There have been incidents of inadvertent air treatments with risk of DCS to the patient. There is some concern with an adequate therapeutic level of oxygen when air is used as a diluent to decrease the oxygen level for air breaks. The recovery time can be considerable and this compromises the patient's prescribed oxygen dosing.

14.2.9.4.2.2* Site surveys (not necessarily UHMS Accreditation surveys) have shown a variety of oxygen monitoring methods that are very inadequate, such as having only one oxygen sample port in a multiplace lock full of patients. Dr. Sheffield has studied and shown the reality of oxygen pooling around patients receiving HBOT in a Class A. Requiring at least two sample ports will add some measure of increased safety in monitoring for oxygen levels that can be dangerously high around a patient(s).

Having a dedicated oxygen monitor for each line would increase the accuracy of monitoring. For example: One sample line from an area of high oxygen concentrations and the other sample from and area of 21% with both samples feeding into the same monitor will mix and result in an inaccurate measurement. Our standard is 23.5% and the oxygen monitor may be reading well below this and yet have areas of dangerous oxygen pooling. I realize that this standard does not resolve all the potential pooling issues but it does increase the standard for some measure of added safety. The Annex A asterisk was added to give additional information and understanding of the need for this requirement.

14.2.9.4.2.3 Again, site surveys have shown a variety of configurations for monitoring the chamber atmosphere. Long sample lines, with low flows, such as 0.5 LPM, will take a long time to reach the sensor head. Also, the true accuracy at those very slow rates/response times is questionable. Testing the response time is a very simple procedure and increasing this oxygen monitoring standard seems to be a simple mitigation of risk.

14.2.9.4.2.4* Oxygen pooling is a serious concern that seems to be often overlooked. This requirement would help increase the awareness of oxygen pooling and give the proper tool to troubleshoot and resolve areas of pooling. The Annex A asterisk will increase understanding and awareness. It would explain the option of leaving the wand/extension in place, if the response time is within the 10 second limits mentioned above.






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Oxygen levels shall be continuously monitored in any chamber in which nitrogen or other diluent gas is added to the chamber to reduce thevolumetric concentration of oxygen in the atmosphere.


I suggest the committee should have a discussion regarding this requirement. It has always been my understanding that this language was for chambers designed for control of the O2 percent in the chamber using inert gas, The existing language would require any Class B or class A chamber pressurized with air (diluent gas) or when providing an air break in an O2 filled device, to monitor the O2 percent in the chamber. I believe this is good practice but there are few class B chamber manufacturers that design the chamber with O2 percent monitoring capability. At least one UHMS accreditation surveyor has cited a class B facility for not monitoring the O2% when air was added to the chamber atmosphere.

It is best practice to require a air filled chamber to be monitored for O2 percent, what does the commiittee want to do with this language going forward? There are likely to be technology changes in the future.






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14.2 3 .9 4 .6.1 x.x.x? * Air from compressors shall be sampled at least every 6 months and after major repair or modification of the compressor(s).


Move to new section for ITM requirements






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14.2.9.6.2 *

As a minimum, the air supplied from compressors to Class A chambers shall meet the requirements for CGA Grade E. follwing requirements:

(1) Carbon dioxide ≤ 500 ppm v

(2) Carbon monoxide ≤ 10 ppm v

(3) Oil ≤ 0.5 mg/m 3

(4) Odor - none

(5) Total hydrocarbon content (methane) ≤ 25 ppm v

(6) Percent oxygen, balance is predominately nitrogen: 20 - 22%

(7) Moisture to comply with the following table of allowable content versus pressure.


File Name Description ApprovedMoisture_content.docx Maximum storage or supply pressure vs moisure content table


(1) Carbon dioxide is to be specified at ≤ 500 ppmv. At 165 FSW (6 ATA), the surface equivalent value of 0.5% CO2, the accepted upper limit for human breathing, is 833 ppmv. It is recommended that NFPA 99 Chpt consider this limit over the CGA Grade E limit of 1000 ppmv.(2) Oil is to be specified at 0.5 mg/m3, which represents the capability of any modern breathing air compressor and filtration system. This lower specification should be considered rather than the value of 10x larger currently in CGA Grade E (5.0 mg/m3). Hyperbaric chambers for clinical applications need to remain oil-free as far as possible.(3) Moisture according to CGA Grade E is determined as the dew point above which freezing of regulators cannot occur. This applies to air compressed to pressures well in excess of 580 psi and does not apply to the majority of low pressure supply systems (< 220 psi) used in most hospitals. The table provided should be considered for pressures under 580 psi.






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Supply pressure bar (psi)

Max. moisture of air at 1 ATA & 68°F (mg/m3)

5 (72.5) 290

10 (145) 160

15 (220) 110

20 (290) 80

25 (365) 65

30 (435) 55

40 (580) 50

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14.2.9.6.3

As a minimum, the air supplied from compressors to Class B chambers shall meet the requirements for CGA Grade E with the stated in thetable below with the additional limit of no condensable hydrocarbons.


File Name Description ApprovedOil_content.docx


The table shown below contains the requirements for breathing air that meets the oxygen compatibility requirements for pressures up to 4800 psi. This alleviates the responsibility of meeting all USP requirements for normal breathing air used in breathing apparatus that may also be used for mixtures containing high partial pressures of oxygen, including medical, 99% pure grade oxygen. (For example when switching from oxygen to breathing air in the event of an unbreathable environment in the chamber, or for air breaks.)The table should be considered as appropriate for Class B chambers, as well as for systems containing both breathing air, as all as mixtures with high levels of oxygen. (Remember that the BIB or Hood systems usually contain 99% oxygen, but if switched to air in the event of an oxygen toxicity seizure, or in the case of unbreathable atmosphere, then when switching back to oxygen, we may expose 99% oxygen to up to 5 mg/m3 oil if we comply with CDA Grade E air. I did not mention fire….in the case of a fire, I believe we would be doing some major cleaning, if not scrapping most of this equipment.)






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Component Concentration at 1 ATA and 68°F

Oxygen 21 ± 1 %

Moisture ≤ 25 mg/m3

Carbon dioxide ≤ 500 ppmv

Carbon monoxide ≤ 5 mg ppmv

Oil ≤ 0.1 mg/m3

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14.2.9.6.4

When compressed air cylinders are used to provide breathing air in Class A or Class B chambers, the breathing air shall be compressed ormedical air USP, meeting the requirements stated in the revised par 14 . 2.9.6.3 above.


Oil-free compressed air is less onerous to produce than Medical Air.






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14.2.9. 7 1.1

Electrical monitoring equipment used inside the chamber shall comply with the applicable requirements of 14.2.8.


This should be the first requirement under 14.2.9.1 "General".






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14.2.9. 8 2.2 *

Closed-circuit television monitoring of the chamber interior shall be employed for chamber operators who do not have direct visual contact withthe chamber interior from their normal operating location.


The requirement for closed circuit television belongs with Intercommunications.


Related Input RelationshipPublic Input No. 508-NFPA 99-2015 [Section No. A.14.2.9.8]






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14.2.10.2.5

The point of exhaust shall be identified as an oxygen exhaust by a sign prohibiting smoking or open flame.

This must be bilingual and and include a pictograph of fire. All work performed on the roof near exhaust vent must be approved by the HSD.


File Name Description Approved

IMG_4419.JPGShould have 2 signs like this with the other in Spanish. Due to an incident that occurred in my Facility there was a close call where the language barrier played a role in the incident


Maintenance work being done in hospitals is often done by outside contractors that are left on their own with little or no guidance and assistance from facility management. Work being done on a hospitals roof by a contractor that does not speak/understand English is a potential disaster waiting to happen. Old Roofs leak, and need to be repaired. One of these methods requires Hot Tar in which a propane torch is needed to heat the tar and lay the roofing material out.

This scenario played out in my facility where I was alerted by one of the employees from the training department across the hall coming into the HBO suite wondering if we had been smelling a hot tar / new driveway smell in the Hyperbaric area. I immediately went up to the roof of the hospital, where I saw a contractor patching leaks on the roof of the building with a propane torch. He was working within 10’ of the Oxygen exhaust vents on the roof above the chamber. We had a patient in the chamber at the time of the incident. I immediately yelled to the worker to discontinue his work, and extinguish the flame. (There is currently a sign in English Stating Oxygen Exhaust, No Smoking, No Open Flame. The pipes are also painted Green) . There was a language barrier, but the worker complied with my request to stop.

In following up with that incident we have concluded that the language barrier played a large role in this issue, we have just ordered signs in Spanish, as well as signs with pictures to alert workers. Secondly to make sure that your facilities management team is aware of the fire risk, and that there is a protocol in-place to inform your Safety Directors and HBO Techs of any impending work by your O2 exhaust vent pipes.

This disaster was narrowly avoided. Had the weather conditions been right (cool and humid) the oxygen venting outside would not be dissipating as quickly and stay closer to the ground (in this case the roof where the worker was using a torch on the roof). Secondly if this work was being done on a day that chamber maintenance is performed when the emergency vent is tested the roof would have been flooded with the oxygen exhaust.


Submitter Full Name: Bryan Kunze

Organization: Healogics

Street Address:City:State:Zip:Submittal Date: Fri Jun 05 11:00:55 EDT 2015


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Public Input Number 182 (14.2.10.2.5)

14.2.10.2.5

The point of exhaust shall be identified as an oxygen exhaust by a sign prohibiting smoking or

open flame. This must be bilingual and include a pictograph of fire. All work performed on the

roof near exhaust vent must be approved by the HSD.


Maintenance work being done in hospitals is often done by outside contractors that are left on

their own with little or no guidance and assistance from facility management. Work being done

on a hospitals roof by a contractor that does not speak/understand English is a potential disaster

waiting to happen. Old Roofs leak, and need to be repaired. One of these methods requires Hot

Tar in which a propane torch is needed to heat the tar and lay the roofing material out. This

scenario played out in my facility where I was alerted by one of the employees from the training

department across the hall coming into the HBO suite wondering if we had been smelling a hot

tar / new driveway smell in the Hyperbaric area. I immediately went up to the roof of the

hospital, where I saw a contractor patching leaks on the roof of the building with a propane

torch. He was working within 10’ of the Oxygen exhaust vents on the roof above the chamber.

We had a patient in the chamber at the time of the incident. I immediately yelled to the worker to

discontinue his work, and extinguish the flame. (There is currently a sign in English Stating

Oxygen Exhaust, No Smoking, No Open Flame. The pipes are also painted Green). There was a

language barrier, but the worker complied with my request to stop. In following up with that

incident we have concluded that the language barrier played a large role in this issue, we have

just ordered signs in Spanish, as well as signs with pictures to alert workers. Secondly to make

sure that your facilities management team is aware of the fire risk, and that there is a protocol in-

place to inform your Safety Directors and HBO Techs of any impending work by your O2

exhaust vent pipes. This disaster was narrowly avoided. Had the weather conditions been right

(cool and humid) the oxygen venting outside would not be dissipating as quickly and stay closer

to the ground (in this case the roof where the worker was using a torch on the roof). Secondly if

this work was being done on a day that chamber maintenance is performed when the emergency

vent is tested the roof would have been flooded with the oxygen exhaust.

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14.2. 10 1 .3 .3

The supply piping for all air, oxygen, or other breathing mixtures from certified commercially supplied cylinders and portable containers shall beprovided with a particulate filter of 66 microns or finer.

14.2. 10 1 .3. 3. 1

The particulate filter shall meet the construction requirements of ANSI/ASME PVHO-1, Safety Standard for Pressure Vessels for HumanOccupancy, and be located as close as practical to the source.


This requirement is clearly a piping issue and should be located in section 14.2.1.3 "Hyperbaric Piping Requirements", not in 14.2.10 "other Equipment and Fixtures".






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Public Input No. 240-NFPA 99-2015 [ Sections 14.3.1.4.4, 14.3.1.4.5 ]

Sections 14.3.1.4.4, 14.3.1.4.514.3.1. 4.4 5 Emergency Procedures

14.3.1.5.1

Emergency procedures specific to the hyperbaric facility shall be established.

14.3.1. 4 5 . 4.1 2 *

All personnel shall be trained in emergency procedures.

14.3.1. 4 5 .4 .2

Personnel shall be trained to control the chamber and decompress occupants when all powered equipment has been rendered inoperative.

14.3.1. 4 5 . 5 3 *

Emergency procedures and fire training drills shall be conducted at least annually and documented by the safety director.

14.3.1.5.3.1

The time required to evacuate all persons from a hyperbaric area with a full complement of chamber occupants all at treatment pressure shallbe measured annually.

14.3.1.5.3.2

The occupants for the timed evacuation drill shall be permitted to be simulated.


Requirements related to emergency procedures have been relocated to a new section titled "Emergency Procedures". Surveys have shown that compliance with conducting emergency drills is poor. Creating the new section adds emphasis to these requirements.Two requirements on emergency drills previously located in 14.2.4 (chamber ventilation) have been moved to this new section.


Related Input RelationshipPublic Input No. 239-NFPA 99-2015 [Section No. 14.2.4.5] Material from 14.2.4.5 has been moved to new section 14.3.1.5




Street Address:City:State:Zip:Submittal Date: Wed Jun 24 12:18:40 EDT 2015


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14.3.1.5.1 Potential Ignition Sources.

14.3.1.5.1.1* The following shall be prohibited from inside the chamber and the immediate vicinity outside the chamber:

(1) Smoking

(2) Open flames

(3) Hot objects

14.3.1.5.1.2

The following shall be prohibited from inside the chamber:

(1) Personal warming devices (e.g., therapeutic chemical heating pads, hand warmers, pocket warmers)

(2) Cell phones and pagers

(3) Sparking toys

(4) Personal entertainment devices

14.3.1.5.1.3 A Safety Time Out, Pause (STOP) shall be completed prior to chamber operations, the STOP shall include

(1) Right patient, two identifiers

(2) Right treatmentas ordered by the medical director

(3) Right safety; correct level of qualified staff, patient ground verified, no prohibited items, textiles


File Name Description ApprovedSTOP_July_2014.pdf

hyperbaric_and_hypobaric_cha.pdf


It has been shown by Sheffield et all, that some 80% of mishaps have occurred in chambers because of some prohibited item allowed to come into the chamber during operation. The UHMS has adopted a position statement regarding a safety time out modeled after surgery prior to chamber operations. The Joint Commission has patient safety at the top of the list for accreditation. This procedure would be good to have in code as part of a culture change and expectation for our chamber operators.






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UHMS Position Statement

Safety Timeout and Pause “STOP” The Safety Committee of the Undersea and Hyperbaric Medical Society recommends that a Safety Time Out / Pause (STOP) be performed prior to the start of every hyperbaric treatment. A STOP should be completed regardless of multiplace or monoplace operations. A STOP will be performed in order to be compliant with safety goals, to combat complacency, and document completion of our unique safety practices. We recommend that the STOP be modeled after the timeouts performed before surgical procedures. The Practice of Hyperbaric medicine is a procedure-oriented specialty, each patient should have two identifiers verified and the patient should agree to the procedure. For the safety of patients and staff, we strongly encourage documentation of a STOP verifying the “Right patient, Right Treatment and Right Safety”. The STOP should include checking the patient ground (monoplace) and that all prohibited items are removed from the chamber (both monoplace and multiplace). The treatment profile and staffing plan should be confirmed and the completed STOP checklist dated and signed or initialed by two staff members prior to closing the door of the chamber. The society recommends that each hyperbaric facility and institution develop and implement a Safety Timeout and Pause (STOP) protocol with these basic elements. A more detailed protocol may be in order depending the specific needs of the facility. Ref: The Joint Commission, Standards, National Patient Safety Goal, Universal Protocol, accessed 4-12-2014: http://www.jointcommission.org/standards_information/up.aspx Submitted: May 2014 Approved: June 2014 Posted: July 2014

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Add New Section after 14.3.1.5.4.4Products permitted inside of a Class A or Class B chamber shall be tested to ASTM G72 and evaluated by UHMS Material Selection GuidelinesBooklet.


Testing to ASTM G72 and use of the UHMS Booklet will give the safety director and physician in charge a systematic means to determine the safety of a product.






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Public Input No. 278-NFPA 99-2015 [ Section No. 14.3.1.5.4.5(A) ]

(A) Upholstered furniture (fixed or portable), shall be resistant to a cigarette ignition (i.e., smoldering) in accordance with one of the following:

(1) The components of the upholstered furniture shall meet the requirements for Class 1 when tested in accordance with NFPA 260, StandardMethods of Tests and Classification System for Cigarette Ignition Resistance of Components of Upholstered Furniture; ASTM E 1353,Standard Test Methods for Cigarette Ignition Resistance of Components of Upholstered Furniture ; or California Technical Bulletin 133,Flammability Test Procedure for Seating Furniture for Use in Public Occupancies .

(2) Mocked-up composites of the upholstered furniture shall have a char length not exceeding 1 1⁄2 in. (38 mm) when tested in accordance withNFPA 261, Standard Method of Test for Determining Resistance of Mock-Up Upholstered Furniture Material Assemblies to Ignition bySmoldering Cigarettes, or ASTM E 1352, Standard Test Method for Cigarette Ignition Resistance of Mock-Up Upholstered FurnitureAssemblies .


ASTM E1352 and ASTM E1353 have not updated their ignition source and they use a cigarette designed not to ignite textile materials. NFPA 260 and NFPA 261 have been updated and use the correct ignition source. CA TB 133 is a heat release test and does not classify materials as Class 1 for smoldering.


Submitter Full Name: MARCELO HIRSCHLER

Organization: GBH INTERNATIONAL

Street Address:City:State:Zip:Submittal Date: Mon Jun 29 21:26:09 EDT 2015


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14.3.1.5.4.6 Mattresses.

Mattresses Mattress components shall have a char length not exceeding 2 in. (51 mm) when tested in accordance with 16 CFR 1632, Standardfor the Flammability of Mattresses and Mattress Pads (FF 4-72) ; 16 CFR Part 1633, Standard for the Flammability (Open Flame) of MattressSets ; or California Technical Bulletin 129, Flammability Test Procedure for Mattresses for Use in Public Buildings or NFPA 260, StandardMethods of Tests and Classification System for Cigarette Ignition Resistance of Components of Upholstered Furniture .

Mattresses shall have limited rates of heat release when tested in accordance with ASTM E 1590 E1590 , Standard Test Method for Fire Testingof Mattresses, as follows:

(1) The peak rate of heat release for the mattress shall not exceed 100 kW. The peak rate of heat release for the mattress shall not exceed100 kW.

(2) The total heat released by the mattress during the first 10 minutes of the test shall not exceed 25 MJ.


Neither 16 CFR 1633 nor CA TB 129 assess smoldering, which is what 16 CFR1632 and NFPA 260 do. Moreover, both 16 CFR 1632 and NFPA 260 deal with components of mattresses and not the full mattress.






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14.3.1.5.4.6 Mattresses.

Mattresses shall have a char length not exceeding 2 in. (51 mm) when tested in accordance with 16 CFR 1632, Standard for the Flammability ofMattresses and Mattress Pads (FF 4-72); 16 CFR Part 1633, Standard for the Flammability (Open Flame) of Mattress Sets; or CaliforniaTechnical Bulletin 129, Flammability Test Procedure for Mattresses for Use in Public Buildings.

Mattresses shall have limited rates of heat release when tested in accordance with ASTM E 1590, Standard Test Method for Fire Testing ofMattresses, as follows:

(1) The peak rate of heat release for the mattress shall not exceed 100 kW. The peak rate of heat release for the mattress shall not exceed100 kW.

(2) The total heat released by the mattress during the first 10 minutes of the test shall not exceed 25 MJ.


The section title of Mattresses should be deleted because it leads the user of the document to believe that sections 14.3.15.4.7 through 14.3.1.5.4.9 are subordinate to 14.3.1.5.4.6.






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14.3.1.5.4.7

Fill materials contained within upholstered furniture and mattresses shall comply with the open flame test in Section A-1 of the 2000 edition ofCalifornia Technical Bulletin 117 Requirements, Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling MaterialsUsed in Upholstered Furniture.


This is just clarification, since the latest edition of the standard no longer has an open flame test, which was what the requirements used to be.






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The use of flammable hair sprays, hair oils, and skin oils shall be forbidden prohibited for all chamber occupants/patients as well as personnel.


Try to use another word than forbidden






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14.3.1.5.7

Drapes used within the chamber shall meet the flame propagation performance criteria contained in Test 1 or Test 2, as appropriate, of NFPA701, Standard Methods of Fire Tests for Flame Propagation of Textiles and Films.


NFPA 101 and NFPA 5000 (and other documents) have been revised as shown because the reference to just NFPA 701 has led to "cheating" by using a "small-scale test" that has been eliminated from NFPA 701 in the 1980s because it was an invalid test that did not represent improved fire performance.






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14.3. 2. 1. 6 5.9 *

Paper brought into the chamber shall be stored in a closed metal container.


This requirement is out of place currently and is better located in this section.



Public Input No. 527-NFPA 99-2015 [Section No. A.14.3.2.1.6]






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14.3. 2 1 . 5.9. 1 .7

Containers used for paper storage shall be emptied after each chamber operation.


this section is subordinate to the requirement in section 14.3.1.5.9.








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14.3.4 Inspection, Testing and Maintenance.

14.3.4.1 General.

14.3.4.1.1

The hyperbaric safety director shall ensure that all valves, regulators, meters, and similar equipment used in the hyperbaric chamber arecompensated for use under hyperbaric conditions and tested as part of the routine maintenance program of the facility.

14.3.4.1.1.1

Pressure relief valves shall be tested and calibrated as part of the routine maintenance program of the facility.

14.3.4.1.2

The hyperbaric safety director shall ensure that all gas outlets in the chambers are labeled or stenciled in accordance with CGA C-4, StandardMethod of Marking Portable Compressed Gas Containers to Identify the Material Contained.

14.3.4.1.3

The requirements set forth in Section 5.1 and NFPA 55, Compressed Gases and Cryogenic Fluids Code, concerning the storage, location, andspecial precautions required for medical gases shall be followed.

14.3.4.1.4

Storage areas for hazardous materials shall not be located in the room housing the hyperbaric chamber. (See 14.2.1.)

14.3.4.1.4.1

Flammable gases, except as provided in 14.3.1.5.2.2 (1), shall not be used or stored in the hyperbaric room.

14.3.4.1.5

All replacement parts and components shall conform to original design specification.

14.3.4.2 Maintenance Logs.

14.3.4.2.1

Installation, repairs, and modifications of equipment related to a chamber shall be evaluated by engineering personnel, tested under pressure,and approved by the safety director.

14.3.4.2.1.1

Logs of all tests shall be maintained.

14.3.4.2.2

Operating equipment logs shall be maintained by engineering personnel.

14.3.4.2.2.1

Operating equipment logs shall be signed before chamber operation by the person in charge. (See A.14.3.1.3.2.)

14.3.4.2.3

Operating equipment logs shall not be taken inside the chamber.


Create one section where all the ITM requirements are located, this will require renumbering, search of the chapter for missed opportunities and most likely new annex notes. PI already submitted may support this idea.






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14.3.6* Electrostatic Safeguards. Inspection, Testing and Maintenance

14.3.6.1 Administration. (Reserved)

14.3.6.2 Maintenance. Electrostatic safeguards

14.3.6.2.1 Furniture Used in the Chamber and grounding .

14.3.6.2.1.1

Conductive devices on furniture and equipment shall be inspected to ensure that they are free of wax, lint, or other extraneous material thatcould insulate them and defeat the conductive properties.

14.3.6.2.1.2*

Casters or furniture leg tips shall not be capable of impact sparking.

14.3.6.2.1.3

Casters shall not be lubricated with oils or other flammable materials.

14.3.6.2.1.4

Lubricants shall be oxygen compatible.

14.3.6.2.1.5

Wheelchairs and gurneys with bearings lubricated and sealed by the manufacturer shall be permitted in Class A chambers where conditionsprescribed in 14.2.9.4 are met.

14.3.6.2.2 Conductive Accessories.

Conductive accessories shall meet conductivity and antistatic requirements.

14.3.6.2. 3

Patient ground shall be verified in class B chambers prior to each chamber operation and for class A chambers as stipulated by the SD

14. 3 .6.2.4

Chamber ground shall be verified for class A and class B chambers as part of the PM program of the facility

14.3.6.2.3 *

Materials containing rubber shall be inspected as part of the routine maintenance program of the facility, especially at points of kinking.

14.3. 6.3 7 Fire Protection Equipment Inside for class A Hyperbaric Chambers.

14.3.6 7 .3. 1


14.3.6 7 .3. 2


14.3.6 7 .3.3


14.3.6.4 8 * Housekeeping.


14.3.6 8 .4. 1







Suggest one section where all the inspections, testing and maintenance requirements are located.






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14.3. 6.3 7 Fire Protection Equipment Inside for class A Hyperbaric Chambers.

14.3. 6 7 . 3. 1

Electrical switches, valves, water level, air pressure and electrical monitoring equipment associated with fire detection and extinguishment shallbe visually inspected before each chamber pressurization.

14.3. 6 7 . 3. 2


14.3. 6 7 .3 .3


14.3.7.4*

Applicable sections of NFPA 25, 2014 edition, chapter 9 Water storage tanks, Table 9.1.1.2 shall be used as a guide for the inspection, testingand maintnence of the water storage tanks for class A chambers


This section is listed under electrostatic safeguards and should have it own section.

NFPA 25 scope is minimum standards for the inspection, testing and maintenance of water based fire protection equipment. I suggest we look at this as a committee and decide if it is appropriate or not to reference it. There is at least one facility that has been cited by the AHJ because they had not documentation that they were following NFPA 25. Our deluge systems are water based. I have been using chapter 9 for ITM of our class A chamber water storage tank for 8 years and have found it a useful tool.

There will need to be an annex note, not all class a chamber sytems are designed with access to the interior of the water storage tank and 25 is to be used as a guide for ITM not a requirement.








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14.3. 6.3 7 Fire Protection Equipment Inside Hyperbaric Chambers.

14.3. 6 7 . 3. 1


14.3. 6 7 . 3. 2


14.3. 6 7 .3 .3



The information in sections 14.3.6.3 "Fire Protection Equipment Inside Hyperbaric Chambers" should not be subordinate to section 14.3.6 "Electrostatic Safeguards", but should be equal to section 14.3.6.








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14.3.6.4 8 * Housekeeping.


14.3.6 8 .4. 1







This section is titled electrostatic safeguards, Housekeeping should have its own number.






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14.3. 6.4 8 * Housekeeping.


14.3. 6 8 . 4. 1







The information in sections 14.3.6.4 "Housekeeping" should not be subordinate to section 14.3.6 "Electrostatic Safeguards", but should be equal to section 14.3.6.



Public Input No. 530-NFPA 99-2015 [Section No. A.14.3.6.4]






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Public Input No. 231-NFPA 99-2015 [ Section No. A.14.2.2.5 ]

A.14.2.2.5 .2

One common hazard of paint fires in ships is related to welding or burning operations on one side of a metal bulkhead that heats the metal to apoint where the paint on the opposite side ignites. Most paints are not flammable when installed as thin layers over a substantial heat sink, suchas the thick steel walls of a hyperbaric chamber, unless the walls are heated first. The same paints, when ground into a powder or installed overa very thin metal substrate, can burn readily. The paint selected for use in the interior walls of a hyperbaric chamber should be selected both forsuitability to the requirements of the application and for its combustibility properties. The hazard of a fire increases as the amount of heat sink isreduced. Therefore, combustion is easier to achieve when paint is applied over thin materials and when there are multiple layers of paint. On thinsection materials that are easily heated, care should be exercised in selecting the flammability characteristics of the paint and the amount ofpaint applied.


The existing annex material is relevant to paragraph 14.2.2.5.2. When the content of section 14.2.2.5 was last changed, this annex material was not relocated accordingly.








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Public Input No. 312-NFPA 99-2015 [ Section No. A.14.2.4.5.3 ]

A.14.2.4.5.3 The intent of this requirement is to allow facility staff to safely evacuate

the facility

a hyperbaric chamber and avoid breathing contaminated air.This

This requirement is permitted to be met using either a self-contained breathing apparatus, smoke hood with integral filter/air supply, or similar technology.

The number of units available should be adequate to meet facility staffing.

The breathing duration of the personal protection devices should be predicated upon the time necessary for evacuation of the facility.

Facility evacuation time

and/or a supplied air respirator.

The Hyperbaric Safety Director should include all available resources when determining the number and design of the breathingapparatus(s). The number of chambers, type of chambers and normal/emergent operations will play a big role in his/her decision.

Evacuation time(s) from the chamber(s) should be determined during fire drills conducted by the

hyperbaric facility.

Hyperbaric Safety Director.

It is not the intent of this requirement to have staff use equipment normally reserved for fire fighters. They are technical/clinical peoplesupporting evacuation efforts until the fire department shows up.

It is not the intent of this requirement to require the omission of all occupants’ and staff’s decompression obligation during theevacuation process. Based on the situation in real time, a facility may choose to delay evacuation until after all passengers’decompression obligation is met.

It is not the intent of this requirement to exclude the use of smoke hoods with integral filter as a secondary system for extra staff tosupport the evacuation effort.


Better match the Annex with the proposed changes to 14.2.4.5.3*Respectfully submitted by:William Davison, CHT ([email protected])Gregory Raleigh, CHT, RCP ([email protected])


Submitter Full Name: WILLIAM DAVISON

Organization: OxyHeal Health Group

Street Address:City:State:Zip:Submittal Date: Wed Jul 01 16:51:43 EDT 2015


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Public Input No. 347-NFPA 99-2015 [ New Section after A.14.2.8.3.17 ]

Inert Gas Purging of Electrical DevicesA. 14.2.8.3.18

A.14.2.8.3.18.1

The intent of this section is to mitigate the risks of fire when an electrical device of any type is placed inside the chamber and put under pressure. The requirements of this section are not intended for things such as approved wrist watches and similar approved small battery powereddevices.

A.14.2.8 .3.18.2

(1) Inert gas purging is only one element of the essential risk assessment and management that is critical to safely managing any electricaldevice that is introduced into the chamber. A comprehensive risk assessment with approved safety procedures and mitigation orders needs tobe documented and signed by the medical director, safety director and all who are directly involved, prior to the device being used in thechamber. Available guides for risk assessment of electrical devices are listed in Annex B.14.2.8.3.19.1

(2) Splitting a purge line to supply two or more devices can create a disparity of flow between the multiple gas lines depending on the lengthand resistance of each line. One device may be well protected with high flow and the other device under protected with very little flow. A singleline with a single flowmeter will prevent this and give a measurable way to verify the correct flow to the device. An inert gas flowmeter can bemistaken for an oxygen flowmeter. Each inert gas flowmeter needs to be clearly labled for the inert gas being used.

(3) Oxygen levels of 6% or less will not support combustion under normal clinical hyperbaric conditions. For initial testing, in order to establishthe proper inert gas flow, oxygen levels in the electrical compartments of the device must be tested at all treatment pressures.

(4) Inert gas purging is useful for purging increased heat from the device. For initial testing, in order to establish the proper inert gasflow, temperature levels in the electrical compartments of the device must be tested at all treatment pressures.

(5) Maintaining inert gas pressure at all treatment levels can be accomplished by means of a tracking type regulator outside of the chamber orby placing the regulator inside the chamber with an adequate supply pressure for all treatment pressures.

(6) The chamber operator needs to be alerted to a loss of inert gas flow.

(7) Loss of inert gas to the purged device(s) creates a risks to patients and staff.

(8) Normal inert gas purging is unlikely to lower the oxygen level of the chamber atmosphere during hyperbaric oxygen treatments. However,because inert gas is being introduced into the chamber, an oxygen low alarm limit of 18% needs to be set.

(9) Acrylic boxes / enclosures are sometimes used to make inert gas purging easier. In the event of a fire or smoke inside this box there needsto be some means of drenching the inside device with water, specifically from the hand held hose.

(10) Chambers are made to be air tight. If the chamber doors are closed, for example over night, and the inert gas is inadvertently left on, thereis a potential for the inert gas to accumulate inside the chamber to a dangerous level. This will deplete the oxygen level and becomes a hazardfor anyone entering the chamber.


This information is provided to help clarify the code and give a better understanding and knowledge regarding the intent and purpose of the code and inert gas purging.








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Public Input No. 344-NFPA 99-2015 [ New Section after A.14.2.9.2.1 ]

Oxygen MonitoringA.14.2.9.4.2.2 Chamber atmospheres are typically not homogenous. Oxygen can accumulate in pools or pockets around patients with levelsthat are dangerously high. A single oxygen sample port inside the chamber may not be sufficient to detect increased oxygen levels in anotherarea of the chamber. In this case, a serious increase of oxygen, well above the allowed level of 23.5 percent, goes undetected. Requiring atleast two sample ports provides an increased standard for better assessment the oxygen levels inside the chamber. The requirement for adedicated oxygen analyzer on each line is to prevent false and unsafe readings from two or more sample lines feeding into one oxygen sensor. For example: one sample line may come from an area of 21 percent and the other line come from an area of 50 percent or more. Both linescoming together will mix and give a false low oxygen reading. Having a dedicated oxygen monitor for each sample line will avoid this unsafesituation.

A.14.2.9.4.2.4 The ability to spot check for oxygen leaks and or oxygen pooling is essential for the safe management of oxygen levels. If theminimum 10 second response time required in 14.2.9.4.2.3 is not compromised, the extension or "snooping wand" can be left (in place)connected for easy use.


Explanation notes given for these two Annex A areas will help give better understanding and education as well as increasing the awareness of potentially serious unsafe scenarios.






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A.14.2.9. 8 1.3

It is recommended that information about the status of an anesthetized or otherwise monitored patient be transmitted to the inside chamberattendants via the intercommunications system. As an alternative, the monitor indicators can be placed adjacent to a chamber viewport (orviewports) for direct observation by inside personnel.


This annex note deals with information from monitoring equipment. It fits better with 14.2.9.1.3 than 14.2.9.8.


Related Input RelationshipPublic Input No. 500-NFPA 99-2015 [Section No. 14.2.9.8] Relocating a requirement and an annex note to different locations.






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Public Input No. 527-NFPA 99-2015 [ Section No. A.14.3.2.1.6 ]

A.14.3. 2. 1. 6 5.9

The use of paper should be kept to an absolute minimum in hyperbaric chambers.


Renumbering of annex note to coincide with relocation of requirement.








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A.14.3. 6.4 8

It is absolutely essential that all areas of, and components associated with, the hyperbaric chamber be kept meticulously free of grease, lint, dirt,and dust.


Renumbering of annex note to coincide with requirement.








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Public Input No. 343-NFPA 99-2015 [ Section No. B.14.2.1 ]

B.14.2.1 Fire Inside Chamber.For fire inside the chamber the following procedures should be performed:

(1) Inside Observer:

(2) Activate fire suppression system and/or hand-held hoses.

(3) Advise outside.

(4) Don breathing air mask.

(5) Chamber Operator:

(6) Activate the fire suppression system, if needed.

(7) Switch breathing gas to air.

(8) Decompress the chamber as rapidly as possible.

(9) Medical Personnel (Outside):

(10) Direct operations and assist crew members wherever necessary.

(11) Provide medical support as required.

(12) Other Personnel (Outside):

(13) Notify the fire department by activating fire signaling device.

(14) Stand by with a fire extinguisher (preferably deionized water extinguisher) .

(15) Assist in unloading chamber occupants.


B.14.2.1 (4) (b) In Annex A.14.2.5.1.5 it is explained how valuable time can be lost trying to "snuff out" a hyperbaric oxygen fire with conventional fire extinguishers. It explains that this is "not effective in controlling fires in oxygen-enriched atmospheres." Sprayed water is recognized as the best medium for extinguishing an oxygen enriched fire. Deionized water extinguishers are now available with proper spray heads for extinguishing fires verses the old straight stream water extinguishers. Deionized water is also safe for the user to use on electrical equipment and not be shocked or electrocuted. Deionized water is a safer medium to spray on a patient who may have need of post burn treatment. Other extinguishing mediums may leave undesirable residual power. Deionized water and halotron extinguishers are, to my understanding, the only two types of extinguishers used in hospitals that are considered clean for outside the chamber. Powder extinguishers can leave a residual all over the department that can destroy other electrical equipment in the immediate area. One leading national hospital that I am aware of has replaced all of their power extinguishers for deionized water extinguishers in all of their MRI areas for this reason.


Submitter Full Name: WILLIAM GOSSETTOrganization: CONVERGENT, LLCStreet Address:City:State:Zip:Submittal Date: Sat Jul 04 14:09:06 EDT 2015

National Fire Protection Association Report http://submittals.nfpa.org/TerraViewWeb/ContentFetcher?xsl-RenderAs...

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Public Input No. 411-NFPA 99-2015 [ New Section after B.14.2.2 ]

Inert Gas PurgingB.14.2.8.3.17.7

Inert gas purging is a means to mitigate the risk of fire initiating from an electrical device brought into the chamber. The three main objectives toinert gas purging are to lower the oxygen level to 6% or less, purge increased heat from the device and to help prevent dust accumulation insidethe device. Fire research has demonstrated that under normal conditions a combustion will not take place when the oxygen level is at 6% orless. This is regardless of the treatment pressure and is more related to the ratio of oxygen to the inert gas. With an oxygen level of 6% and thebalancing inert gas level at 94%, the high percentage of inert gas will prevent combustion.

A clear policy and procedure should be written for the inert gas purging systems and include the inert gas parameters for each device and theproper set up of the system.

All testing to determine the proper inert gas flow should be well documented and included in the approved and unapproved documentation. Approval signatures need to be obtained from the medical director and the safety director at minimum. Other signatures should include thedepartment manager and biomed representatives.

Start-up and shut-down checklist need to include inert gas parameters with visual checks and verifications of inside devices, inert gas equipmentand alarms.


This information is given to increase the awareness and understanding of the code and of inert gas purging techniques.


Submitter Full Name: WILLIAM GOSSETTOrganization: CONVERGENT, LLCStreet Address:City:State:Zip:Submittal Date: Mon Jul 06 00:14:11 EDT 2015


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ecarroll

Cross-Out

Public Input No. 341-NFPA 99-2015 [ Section No. B.14.3 ]

B.14.3 Suggested Procedures for Hyperbaric Chamber Operator to Follow in the Event of Fire in a Class B Chambers Chamber room .B.14.3.1 For fires within the facility not involving the chamber, the following procedure should be performed:

(1) If there is smoke in the area, don the operator’s source of breathable gas per 14 .2.4.5.3*.

(2) Decompress the chamber. The urgency of decompression should be determined by the location of the fire.

(3) Remove the patient and evacuate to safe area.

(4) Turn off the oxygen zone valve to the chamber room and close any smoke/fire barrier doors. These steps are consistent with the Rescueand Confine elements of the Rescue, Alarm, Confine, Extinguish (R.A.C.E.) procedure. It is assumed that other personnel will evacuateother patients and visitors from the area and activate a fire alarm signaling device (if not already activated).

B.14.3.2 For fire within the chamber, the following procedure should be performed:

(1) Stop oxygen from flowing into the chamber by switching off the chamber (if the chamber is compressed with oxygen) or switching thesupply gas of a breathing device from oxygen to air (if the chamber is compressed with air).

(2) Decompress the chamber as rapidly as possible following the emergency decompression procedures .

(3) Stand by with a hand-held fire extinguisher (perferably a de-ionized water extinguisher) and spray into the chamber (if necessary) whenthe chamber door is opened.

(4) Remove the patient and evacuate to a safe area.

(5) Turn off the oxygen zone valve to the chamber room and close any smoke/fire barrier doors.

These steps are consistent with the Rescue and Confine elements of the Rescue, Alarm, Confine, Extinguish (R.A.C.E.) procedure. It isassumed that other personnel will evacuate other patients and visitors from the area and activate a fire alarm signaling device (if not alreadyactivated). The injured patient should have appropriate medical attention immediately after evacuation to a safe area. Many Class B chambersrequire oxygen supply pressure to operate a rapid decompression feature. If this is the case, do not turn off the oxygen zone valve or any inlineoxygen supply shutoff valve until all patients have been removed from the chamber(s).


B.14.3 The current wording is somewhat confusing stating "Event of Fire in Class B Chambers." which could be taken to mean a fire INSIDE a Class B Chamber.

B.14.3.2(3) In Annex A.14.2.5.1.5 it is explained how valuable time can be lost trying to "snuff out" a hyperbaric oxygen fire with conventional fire extinguishers. It explains that this is "not effective in controlling fires in oxygen-enriched atmospheres." Sprayed water is recognized as the best medium for extinguishing an oxygen enriched fire. Deionized water extinguishers are now available with proper spray heads for extinguishing fires verses the old straight stream water extinguishers. Deionized water is also safe for the user to use on electrical equipment and not be shocked. Deionized water is a safer medium to spray on a patient who may have need of post burn treatment. Other extinguishing mediums may leave undesirable residual power. Deionized water and halotron extinguishers are, to my understanding, the only two types of extinguishers used in hospitals that are considered clean. Powder extinguishers can leave a residual all over the department that can destroy other electrical equipment in the immediate area. One leading national hospital that I am aware of has replaced all of their power extinguishers for deionized water extinguishers in all of their MRI areas for this reason.


Submitter Full Name: WILLIAM GOSSETTOrganization: CONVERGENT, LLCStreet Address:City:State:Zip:Submittal Date: Sat Jul 04 13:36:44 EDT 2015


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Public Input

(NFPA 99B)

323

Public Input No. 1-NFPA 99B-2015 [ Section No. 2.3 ]

2.3 Other Publications.

2.3.1 ASME Publications.

American Society of Mechanical Engineers, Three ASME International , Two Park Avenue, New York,NY 10016-5990.

ANSI/ ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy, 2012.

ASME Boiler and Pressure Vessel Code,2013 2015 .

2.3.2 ASTM Publications.

ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959.

ASTM D 2863 D2863 , Standard Test Method for Measuring the Minimum Oxygen Concentration to SupportCandle-like Combustion of Plastics (Oxygen Index), 2012.

2.3.3 CGA Publications.

Compressed Gas Association, 4221 Walney Road, 5th Floor 14501 George Carter Way, Suite 103 ,Chantilly, VA 20151-2923.

CGA C- 4, Standard Method of Marking Portable Compressed Gas Containers to Identify the MaterialContained (ANSI Z48.1), 1990. 7, Guide to Classification and Labelling of Compressed Gases, 10thedition, 2014. (Supersedes CGA C-4)

2.3.4 Other Publications.

Merriam-Webster’s Collegiate Dictionary, 11th edition, Merriam-Webster, Inc., Springfield, MA, 2003.


Referenced current SDO names, addresses, standard names, and editions.


Related Input Relationship

Public Input No. 2-NFPA 99B-2015 [Section No. E.1.2]


Submitter Full Name: Aaron Adamczyk

Organization: [ Not Specified ]

Street Address:

City:

State:

Zip:

Submittal Date: Sat Mar 21 18:20:42 EDT 2015


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Public Input No. 19-NFPA 99B-2015 [ Section No. 2.3.2 ]

2.3.2 ASTM Publications.

ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959.

ASTM D 2863, Standard Test Method for Measuring the Minimum Oxygen Concentration to SupportCandle-like Combustion of Plastics (Oxygen Index), 2012.


This standard is mentioned only in the definition of oxygen index (3.3.15), a term not used in the document.

If the reference is to be kept it should be updated to 2014.



Public Input No. 20-NFPA 99B-2015 [Section No. 3.3.15]




Street Address:

City:

State:

Zip:

Submittal Date: Tue Jun 30 01:37:03 EDT 2015


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3.3.7* Flame Resistant (Hypobaric).

A substance meeting the flame propagation performance criteria contained in Test Method 1 or Test Method2, as appropriate, of NFPA 701, Standard Methods of Fire Tests for Flame Propagation of Textiles andFilms , for the chamber atmosphere.

Limited- Combustible (Material). - see NFPA 99 4.4.1.2



99B_PC_2_HOLD.pdf 99B_PC2


NOTE: The following Public Input appeared as "Reject but Hold" in Public Comment No. 2 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1.NFPA 701 small scale test does not exist and this change would bring us in line with the current language in NFPA 99.



Organization: NFPA TC ON HYPERBARIC AND HYPOBARIC FACILITIES

Street Address:

City:

State:

Zip:

Submittal Date: Fri Apr 03 10:20:29 EDT 2015


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Public Input No. 15-NFPA 99B-2015 [ New Section after 3.3.11 ]

Noncombustible (Material)

A material that complies with any of the following shall be considered a noncombustible material:

(1) A material that , in the form in which it is used and under the conditions anticipated, will notignite, burn, support combustion, or release flammable vapors when subjected to fire or heat

(1) A material that is reported as passing ASTM E 136, Standard Test Method for Behavior ofMaterials in a Vertical Tube Furnace at 750°C

(1) A material that is reported as complying with the pass/fail criteria of ASTM E 136 when testedin accordance with the test method and procedure in ASTM E 2652, Standard Test Method forBehavior of Materials in a Tube Furnace with a Cone-Shaped Airflow Stabilizer, at 750 DegreesC

(1) A material that is reported as meeting or exceeding the criteria for a class 1 certification whentested in accordance with the test method and procedure in ASTM E 648: Standard TestMethod for Critical Radiant Flux of Floor-Covering Systems Using a Radiant Heat EnergySource or NFPA 253: Standard Method of Test For Critical Radiant Flux Of Floor CoveringSystems Using A Radiant Heat Energy Source.

TITLE OF NEW CONTENT

Type your content here ...


The addition of the definition of non-combustible (Material) is required due to the use of non-combustible (Material) in NFPA 99B. The addition of the 4th definition in the noncombustible (Material) definition is to ensure the noncombustible pertains to flooring allowed inside of a hypobaric chamber. This recommendation is the result of research conducted while attempting navigate and adhere to code NFPA 99B while selecting a flooring material to install in a hypobaric chamber.


Submitter Full Name: Neil Edmonston

Organization: NAWCTSD

Affilliation: NAVY

Street Address:

City:

State:

Zip:

Submittal Date: Thu Apr 16 13:56:43 EDT 2015


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3.3.15 Oxygen Index.

The minimum concentration of oxygen, expressed as percent by volume, in a mixture of oxygen andnitrogen that will just support combustion of a material under conditions of ASTM D 2863, Standard TestMethod for Measuring the Minimum Oxygen Concentration to Support Candle-Like Combustion of Plastics(Oxygen Index).


The term is not used in NFPA 99B.



Public Input No. 19-NFPA 99B-2015 [Section No. 2.3.2]




Street Address:

City:

State:

Zip:

Submittal Date: Tue Jun 30 01:39:09 EDT 2015


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Public Input No. 13-NFPA 99B-2015 [ Section No. 4.1.1.2 ]

4.1.1.2

All construction and finish materials shall be flame resistant (hypobaric) or noncombustible under(Material) under standard atmospheric conditions.


The addition of (Material) after noncombustible would point the user to the proper definition of noncombustible found in chapter 3 Definitions.




Affilliation: Navy

Street Address:

City:

State:

Zip:



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4.1.1.2

All construction and finish materials shall be flame resistant (hypobaric) or noncombustible limited-combustible (Material 99) under standard atmospheric conditions.



99B_PC5_HOLD.pdf NFPA 99B_PC5


NOTE: The following Public Input appeared as "Reject but Hold" in PUblic Comment No. 5 of the (A2014) Second Draft report for NFPA 99B and per the Regs. at 4.4.8.3.1.Limited combustible (Materials) 99 is the accepted language.




Street Address:

City:

State:

Zip:



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Public Input No. 14-NFPA 99B-2015 [ Section No. 4.2.2 [Excluding any Sub-Sections] ]

Flooring of Class D and E chambers shall be antistatic and flame resistant noncombustible(hypobaric Material ).


The current definition of flame resistant references code NFPA 701: Standard Methods of Fire Tests for Flame Propagation of Textiles and Films. NFPA 701 no longer appears to test or pertain to flooring.




Affilliation: NAVY

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Public Input No. 5-NFPA 99B-2015 [ Section No. 4.2.2 [Excluding any Sub-Sections] ]

Flooring of Class D and E chambers shall be antistatic and flame resistant (hypobaric limited combustible(materials 99 ).





NOTE: The following Public Input appeared as "Reject but Hold" in Public Comment No. 6 of the (A2014) Second Draft report for NFPA 99B and per the Regs. at 4.4.8.3.1.Limited combustible is the current language



Organization: NFPA TC ON HYPBERBARIC AND HYPOBARIC FACILITIES

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4.2.3

The interior of Class D and E chamber shells shall be unfinished or treated with an OEA-compatible finishas follows:

(1) Inorganic zinc–based

High-quality epoxy or

(2) A material that meets Clas A interior finish rating in accordance with NFPA 101 Life Safety Code

(3) A finish that meets or exceeds ASTM E84, BS476 part 6 for flame and smoke or equivalent





NOTE: The following Public Input appeared as "Reject but Hold"in Public Comment No. 7 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1This change will bring 99B in line with 99




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4.2.4

If sound-deadening materials are employed within a hypobaric chamber, they shall be flame resistant(hypobaric). limited- combustible (materials 99)





NOTE: This Public Input appeared as "Reject but Hold" in Public comment No. 8 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1This change brings us in line with the current language




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4.3.6

Gasket material used in lamp fixtures shall be flame resistant (hypobaric Limited-Combustible (Materials99 ) of a type that allows for thermal expansion and rated for the temperature and vacuum attainable withinthe chamber.





NOTE: This Public Input appeared as "Reject but Hold" in Public Comment No. 9 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1This change uses the current language for flame resistant




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4.3.9.3

If portable spot illumination is used, the flexible cord shall be manufactured of flame Limited -resistantCombustible (hypobaric Material 99 ) materials rated for use in 100 percent oxygen at normal atmosphericpressure.





NOTE: This Public Input appeared as "Reject but Hold" in Public Comment No. 10 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1This changes uses the current language for flames resistant




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4.4.3.5

When installed in Class E chambers, flame-resistant (hypobaric Limited Combustible (Materials 99 )packing and OEA-compatible lubricants shall be used on the fan shaft.





NOTE: This Public Input appeared as "Reject but Hold" in Public Comment No. 11 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1This change uses the current language for flames resistant




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Public Input No. 16-NFPA 99B-2015 [ Section No. 4.6.2.3 [Excluding any Sub-Sections] ]

If handheld extinguishers are provided in a single compartment chamber, at least two water mistextinguishers with ratings of 2-A:C shall be provided.


Extinguishers with Class A ratings should be installed for the potential of fires involving common combustibles (Class A fires). Listed water mist extinguishers are rated for Class C fires and are therefore safe to use around energized electrical equipment. This type of extinguisher is most appropriate for hypobaric chambers.


Submitter Full Name: Jennifer Boyle

Organization: Mark Conroy, Brooks Equipment Company

Affilliation: Fire Equipment Manufacturers Association

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Submittal Date: Fri May 22 11:59:04 EDT 2015


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Public Input No. 17-NFPA 99B-2015 [ Section No. 4.6.2.3.1 ]

4.6.2.3.1

If the chamber has two compartments, at least two water mist extinguishers, each with a rating of 2-A:Cshall be provided in the main compartment and one water mist extinguisher with a rating of 2-A:C shall beprovided in the personnel transfer compartment.


Extinguishers with Class A ratings should be installed for the potential of fires involving common combustibles (Class A fires). Listed water mist extinguishers are rated for Class C fires and are therefore safe to use around energized electrical equipment. This type of extinguisher is most appropriate for hypobaric chambers.


Submitter Full Name: Jennifer Boyle

Organization: Mark Conroy, Brooks Equipment Company

Affilliation: Fire Equipment Manufacturers Association

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Submittal Date: Fri May 22 12:09:04 EDT 2015


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4.7.2.1*

All electrical equipment installed or used in a Class E hypobaric chamber or lock shall be approved for usein Class I, Division 1, Group C locations and flame resistant (hypobaric limited combustible (materials 99 )in 100 percent oxygen at normal atmospheric pressure or be designated intrinsically safe for theatmosphere.





NOTE: The following Public Input appeared as "Reject but Hold" in Public Comment No. 12 of the (A2014) Second Draft report for NFPA 99B and per the Regs. at 4.4.8.3.1This change uses the current language for flame resistant




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5.1.7.6

Items such as seating covers, sheets, drapes, and blankets used in Class E chambers shall be made offlame-resistant (hypobaric) materials Limited combustible material (Materials 99) that meet therequirements of 5 3 . 1 3 .7. 5.





NOTE: The following Public Input appeared as "Reject but Hold" in Public comment No. 4 of the (A2014) Second Draft Report for NFPA 99B and per the Regs. at 4.4.8.3.1There is no small scale test




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Public Input No. 2-NFPA 99B-2015 [ Section No. E.1.2 ]

E.1.2 Other Publications.

E.1.2.1 ASME Publications.

American Society of Mechanical Engineers, Three ASME International , Two Park Avenue, New York,NY 10016-5990.

ANSI/ ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy , 2012 .

E.1.2.2 Ocean Systems, Inc. Publications.

Ocean Systems, Inc., Research and Development Laboratory, Tarrytown, NY 10591.

Work carried out under U.S. Office of Contract No. N00014-67-A-0214-0013. Ocean Systems, Inc.,“Technical Memorandum UCRI-721, Chamber Fire Safety.” (Figure A.3.3.3.3 is adapted from Figure 4,“Technical Memorandum UCRI-721, Chamber Fire Safety,” T. C. Schmidt, V. A. Dorr, and R. W. Hamilton,Jr.)

Work carried out under U.S. Office of Naval Research, Washington, DC, Contract No. N00014-67-A-0214-0013. (G. A. Cook, R. E. Meierer, and B. M. Shields, “Screening of Flame-Resistant Materials andComparison of Helium with Nitrogen for Use in Dividing Atmospheres.” First summary report under ONRContract No. 0014-66-C-0149. Tonawanda, NY: Union Carbide, 31 March 1967. DDC No. Ad-651583.)


Updated ASME name and address.



Public Input No. 1-NFPA 99B-2015 [Section No. 2.3] Updated ASME name and address.


Submitter Full Name: Aaron Adamczyk

Organization: [ Not Specified ]

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Submittal Date: Sat Mar 21 18:23:55 EDT 2015


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august 5 - 6, 2015, baltimore, md

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