Easy on-Desk

Issued September 2008 Version 1.05May

IMPORTANT : Read this Manual carefully before operating the instrument.

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FOREWORD CONGRATULATIONS on your purchase of the Easy on-Desk Spirometer. The Easy on-Desk combines the vast experiences of Fukuda Sangyo Japan of providing customer interfaces in lung function technology and the revolutionary sensor technology TrueFlow by ndd Switzerland currently changing the way LFT is done. The Easy on-Desk is marketed exclusively by ndd Medical Technology Switzerland through its worldwide distributor network: www.ndd.ch. To assist you in the operation of this instrument, we have prepared this User’s Manual. The manual was arranged for first-time users of this instrument. Hence the approach taken in writing this manual is simple and appropriate for those without previous background on the use of electronically operated spirometers or microcomputer equipment. It is essential that you be first acquainted with the procedures and terminologies used in this manual before operating the instrument. This manual is however not a guide to the implementation of procedures for respiratory maneuvers and measurements. We presume that the clinical personnel or technician who will take the measurements of the patients is well trained on the techniques for conducting the required maneuvers. Consult an appropriate reference material on how to set patients and how to perform proper measurements whenever necessary. Follow the locally applicable recommendations and guide lines. NOTE: Easy on-Desk does not require calibration since it applies the ndd TrueFlow technology. For proof of long term stability of ndd TrueFlow, refer to www.ndd.ch downloads section. Any documents referring to EasyOne are applicable also for Easy on-Desk (the same worldwide proven ndd TrueFlow technology is applied). Depending on your purchased inclusions, this User’s Manual may be a non-English document release. If a translation conflict arises, please always refer to the official manual written in English. This User’s manual is constantly being reviewed and revised. Necessary improvements shall be incorporated and updates may be sent to you upon request once available, or maybe downloaded from the net. Please consult regularly our homepage www.ndd.ch for updates as well as for other information relevant to this or other ndd products.

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TABLE OF CONTENTS TABLE OF CONTENTS ..................................................................................................... 2 CHAPTER I. PRODUCT DESCRIPTION .................................................................... 4

1.1. INTRODUCTION ........................................................................................... 4 1.2. INTENDED TESTS......................................................................................... 4 1.3. MEASURING PRINCIPLE............................................................................. 4 1.4. USER INTERFACE ........................................................................................ 4 1.5. NEW FEATURES ........................................................................................... 5 1.6. BLOCK DIAGRAM ........................................................................................ 5 1.7. CONTRAINDICATION.................................................................................. 5

CHAPTER II. INSTRUCTIONS FOR SAFE OPERATION ......................................... 6 CHAPTER III. SPECIFICATIONS .............................................................................. 9

3.1 MEASUREMENT SPECIFICATIONS .......................................................... 9 3.2 INTERFACE SPECIFICATIONS ................................................................... 9 3.3 OTHER SPECIFICATIONS ......................................................................... 10 3.4 INSTRUMENT CLASSIFICATION ............................................................ 10 3.5 STANDARDS COMPLIANCE..................................................................... 10 3.6 DECLARATION - ELECTROMAGNETIC EMISSIONS .......................... 11 3.7 DECLARATION - ELECTROMAGNETIC IMMUNITY ........................... 12 3.8 RECOMMENDED SEPARATION DISTANCE.......................................... 14

CHAPTER IV. PACKAGE CONTENTS ................................................................... 15 CHAPTER V. PARTS IDENTIFICATION .................................................................. 16

5.1 Easy on-Desk MAIN UNIT ........................................................................... 16 5.2 TrueFlowTM FLOW SENSOR ....................................................................... 17 5.3 STANDARD CONSUMABLES ................................................................... 18 5.4 OPTIONAL ACCESSORIES ........................................................................ 19 5.5 OPERATIONAL KEYS LAYOUT ............................................................... 20

CHAPTER VI. DISPLAY ........................................................................................... 21 6.1 PARAMETERS DEFINITION ..................................................................... 21 6.2 FACTORY DEFAULT SETTINGS .............................................................. 23

CHAPTER VII. CAUTIONS ....................................................................................... 24 7.1 SAFETY INSTRUCTIONS FOR USE ......................................................... 24 7.2 ELECTROMAGNETIC COMPATIBILITY ................................................ 28 7.3 HANDLING CONSUMABLES .................................................................... 28

CHAPTER VIII. BASIC OPERATION ........................................................................ 30 8.1 ASSEMBLING THE INSTRUMENT .......................................................... 30 8.2 READYING THE TrueFlowTM FLOW SENSOR ........................................ 31 8.3 LOADING A THERMAL RECORDING PAPER ....................................... 32 8.4 POWERING THE INSTRUMENT ............................................................... 33

CHAPTER IX. OPERATION ..................................................................................... 36 9.1 GENERAL OPERATING FUNCTION ........................................................ 36 9.2 DETAILED OPERATING SEQUENCE ...................................................... 37 9.3 MAIN MENU SCREEN ................................................................................ 38

CHAPTER X. PATIENT INFORMATION ENTRY................................................ 40 CHAPTER XI. MEASURING MODES ..................................................................... 44

11.1 SETTING-UP ................................................................................................ 44 11.2 VITAL CAPACITY - [VC] ........................................................................... 45 11.3 FORCED VITAL CAPACITY - [FVC] ........................................................ 49

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11.4 MAXIMUM VOLUNTARY VENTILATION - [MVV] ........ ...................... 53 11.5 POST MEASUREMENT - [POST] .............................................................. 56 11.6 BRONCHIAL CHALLENGE - [BC] ............................................................ 59

CHAPTER XII. DATA STORAGE (Dbase) ............................................................... 67 12.1 PATIENT DATA EDITING - [1. Edit] ......................................................... 68 12.2 PATIENT DATA LOADING - [2. Load] ..................................................... 69 12.3 PATIENT DATA DELETING - [3. Del] ...................................................... 70 12.4 PATIENT DATA LISTING - [4. List] ......................................................... 73 12.5 PATIENT DATA SAVING - [5. Save] ......................................................... 74

CHAPTER XIII. PRINTING INTERNALLY (Print) .................................................. 76 13.1 BASELINE DATA PRINTING .................................................................... 76 13.2 PRE/POST DATA PRINTING...................................................................... 79 13.3 BRONCHIAL CHALLENGE DATA PRINTING ....................................... 82 13.4 CALIBRATION CHECK DATA PRINTING .............................................. 84

CHAPTER XIV. PRINTING EXTERNALLY (Print) ................................................. 85 14.1 BASELINE DATA PRINTING .................................................................... 86 14.2 PRE/POST DATA PRINTING...................................................................... 87 14.3 BRONCHIAL CHALLENGE DATA PRINTING ....................................... 88

CHAPTER XV. UTILIY (Util) .................................................................................... 90 15.1 OPERATING SETTINGS - [1. System Mode] ............................................. 91 15.2 PATIENT DATA UPLOADING - [2. Transmission] ................................... 95 15.3 PRINT SETTINGS - [3. Print Mode] ............................................................ 99 15.4 SYSTEM DATE/TIME SETTING - [4. System Date] ............................... 101 15.5 DISPLAY CONTRAST SETTING - [5. LCD Contrast] ............................ 103

CHAPTER XVI. DIAGNOSTICS............................................................................... 104 16.1 KEYBOARD TESTING - [1. Keypad] ....................................................... 105 16.2 LCD TESTING - [2. LCD] .......................................................................... 106 16.3 PRINTER TESTS - [3. Printer] ................................................................... 107 16.4 RAM TESTS - [4. RAM]............................................................................. 108 16.5 ROM TESTS - [5. ROM]............................................................................. 109 16.6 SERIAL PORT TESTS - [6. Serial Port]..................................................... 110 16.7 CALIBRATION CHECK - [7. Cal Check] ................................................. 111 16.8 SYSTEM INITIALIZE - [8. System Init].................................................... 115

CHAPTER XVII. CLEANING AND STERILIZING ................................................ 116 CLEANING THE EXTERNALS ............................................................................ 116 CLEANING THE NOSE CLIP ............................................................................... 116

CHAPTER XVIII. SAFEKEEPING ............................................................................ 117 CHAPTER XIX. MAINTENANCE AND INSPECTION .......................................... 118 CHAPTER XX. AFTER SALES SERVICE .............................................................. 121

WARRANTY .......................................................................................................... 121 PRODUCT LIFE ..................................................................................................... 121

APPENDIX 1. Predicted Equations ............................................................................. 122 APPENDIX 2. Interpretation Algorithms..................................................................... 137 APPENDIX 3. Bronchial Challenge Dosage Templates .............................................. 143 APPENDIX 4. Trouble Shooting ................................................................................. 144

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CHAPTER I. PRODUCT DESCRIPTION 1.1.INTRODUCTION The Easy on-Desk is a Pulmonary Function Testing (PFT) instrument intended for performing patho-physiological breathing tests to evaluate human respiratory functionality. General physicians, respiratory practitioners, and qualified medical technicians use this instrument in medical hospitals, medical centers, and clinics during patients’ visit. 1.2.INTENDED TESTS Using present-day technologies, this instrument basically measures accurately and reliably patients’ respiratory functions while obtaining immediate measurement results. This instrument carries out measurement of a patient’s pulmonary (Slow) Vital Capacity (VC), Forced Vital Capacity (FVC), and Maximum Voluntary Ventilation (MVV) while performing a prescribed breathing maneuver. 1.3.MEASURING PRINCIPLE Under room condition, the patient is made to breathe air through the tubular-portion of a flow sensor following a pre-defined breathing maneuver. The flow sensor is a low-resistance free-flow tube that requires no energy transfer between this instrument and the patient to effect measurement. Only the airflow is used to obtain the needed flow data In this Spirometer model, the patient’s breathing effort is tracked with the use of an Ultrasonic Flow Sensor. In determining the transpiring airflow, serial ultrasonic pulses within the flow sensor are transmitted diagonally along the patient’s breathing flow stream. Precisely measured times of flight of the said pulses are the basis for shaping the real time flow data. The resulting flow data is subsequently normalized and converted to digital data and fed to the input/output subsystem of the onboard microprocessor. 1.4.USER INTERFACE With its built-in microprocessor, the flow digital data is processed and kept into this Spirometer’s memory. The requisite respiratory graphical and parametric readings are then collated from the aforesaid measurement data and next displayed on the LCD screen, printed on the built-in printer, or may be transferred into the system’s data management system. All the foregoing operations directed through a keyboard. The interface of this Spirometer has the ability to do analysis versus selectable spirometric indices, Post-Medication comparative testing or Bronchial Challenge assessment in a manner useful for clinical analysis. Complemented by its desktop design, large patient record memory, and conveniently accessible menus. Furthermore, the measurement modes (VC, FVC & MVV) menus are readily accessible by an assigned

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function key. Enabling users to easily shift operation from any measuring mode. The command to print function is likewise assigned a [PRINT] key. This feature makes possible to print results without needing to exit from a measurement mode. Expanding its influence, this Spirometer may electronically upload kept measurement results and their corresponding waveforms to a Personal Computer (PC) through the optionally available FS/PC Database Management software (for your PC to receive the uploaded data). 1.5.NEW FEATURES This Spirometer model includes: � Use of the digital ultrasonic flow measuring technology; � Bronchial challenge dosage concentration standard and customizable templates

(for Methacholine, Histamine, and Antigen); � Global Obstructive Lung Disease (GOLD) interpretation option; � User friendly interface; � Wider display screen; and, � Easy load printer.

1.6.BLOCK DIAGRAM 1.7.CONTRAINDICATION Contraindication in the use of this instrument lies solely in the skill of the clinical personnel supervising the pulmonary test to motivate and persuade cooperation from the patient for optimal measurement results.

System ControllerKeypad

Ultrasonic FlowSensor

LCD

Program ROM /Scratchpad RAM

Power-onSupervisor

Real Time Clock

DatabaseMemory

Buzzer

Internal Printer External Printer Serial Port

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CHAPTER II. INSTRUCTIONS FOR SAFE OPERATION Read all the safety instructions carefully to correctly and safely use and operate this instrument. The instructions given should always be adhered to for safety importance. 2.1 DESCRIPTION OF ALERT LABELS USED IN THIS INSTRUMENT An alert indication specifies the levels of damage and loss resulting from improper use or ignorance of the alert indications. The alert indications and symbols used in this instrument are classified and explained as follows:

Symbol marked on the instrument for protection from damage. The meaning of this symbol is explained below.

There is an imminent risk of death, serious physical injury or fire resulting from improper handling by ignoring this indication.

There is a possibility of death, serious physical injury or fire resulting from improper handling by ignoring this indication.

There is a possibility of personal injury or physical loss resulting from improper handling by ignoring this indication.

2.2 ALERT LABELS USED IN THIS INSTRUMENT

RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

ELECTRIC SHOCK HAZARD. DO NOT REMOVE COVER. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.

DANGER

WARNING

CAUTION

DANGER

CAUTION

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Alert label on instrument body

The alert label attached to the instrument body that indicates precautions should not be defaced or disfigured, and the inscriptions on them should not be erased. This label indicates an important matter for proper and safe handling should the instrument be accidentally broken or damaged.

2.3 SYMBOLS AND MEANINGS OF LABELS USED IN THIS INSTRUM ENT

DIRECT CURRENT (DC)

ALTERNATING CURRENT (AC)

EQUIPOTENTIAL GROUND

OFF (POWER DISCONNECTED FROM THE MAINS)

ON (POWER CONNECTED TO THE MAINS)

TYPE BF APPLIED PART

ELECTROSTATIC DISCHARGE SENSITIVE CONNECTOR (DEVICE)

CAUTION

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2.4 SYMBOLS AND MEANINGS OF LABELS USED IN THIS MANUAL

� Important

� Note

� Additional Note

� Manual Operation

� Patient Action

� Accessing the Screen

� Exiting the Screen

� Screen Display

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CHAPTER III. SPECIFICATIONS 3.1 MEASUREMENT SPECIFICATIONS

1) Measurement Method Flow detection Time of Flight Ultrasonic Flow Sensor Volume detection Flow integration

2) Measurement Range Flow range 0 to ±14 L/S Volume range 0 to 10 L

3) Measurement Accuracy Flow range

(See Note a) Specified value ±5% or ±0.2 L/s, whichever is greater

Volume range (See Note a)

Specified value ±3% or ±50 mL, whichever is greater

4) Measurements Durations and Times Vital Capacity 60 seconds capture time/test, three times. Forced Vital Capacity 30 seconds capture time/test, three times. Max. Voluntary Ventilation 12 seconds capture time/test, two times. Post Measurement

(Bronchodilator) See VC, FVC & MVV features.

Bronchial challenge test (BC) (See Note b)

o Baseline: one (1) entry. o Saline Inhalation: one (1) entry. o DOSE Inhalations and Dilator Inhalations:

limited to eighteen (18) entries. Note a: Measurement accuracy for readings exceeding the measurement range is not warranted. Note b: Allowable entries are limited to a total of twenty (20).

3.2 INTERFACE SPECIFICATIONS

1) Ultrasonic Flow Sensor Polarized (female) DB-9 RS-232

Compatible: Serial port dedicated for patient data acquisition

2) Display Liquid Crystal Display: 16 characters x 16 lines (text)

128 x 128 pixels (graphics) 3) Internal Printer Thermal type: 36 characters/line

4) Database Memory Space Flash RAM: 145 patient records (measurements &

waveforms) 5) Serial Port Standard DB-9 RS-232 Compatible: Single port dedicated for the patient

data upload option. 6) External Printer Centronics Compatible: Parallel port for External Printer

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3.3 OTHER SPECIFICATIONS

1) Supply Voltage AC Mains: 100 ~ 240 VAC; 50/60 Hz Consumption: 0.32 A

2) Environmental Conditions for Operation Ambient Temperature: 10ºC ~ 40ºC Relative Humidity: 80% or less (non-condensing)

3) Environmental Conditions for Transport & Storage Ambient Temperature: -20ºC ~ 60ºC Relative Humidity: 95% or less (non-condensing)

4) Physical Attributes Spatial Dimensions:

Main Unit (spatial) Rear Handle (spatial) Sensor Holder with Sensor (no Spirette)

250.0 (L) x 250.0 (W) 80.5 (H) mm 43.5 (L) x 250.0 (W) mm 175.0 (L) x 50.0 (W) x 110.0 (H) mm

Weight (See Note c): Main Unit: TrueFlow Sensor:

1.80 Kilograms (approx.); 0.20 Kilograms (approx.)

Casing material ABS (formaldehyde-free) Note c: The recording paper is not loaded.

3.4 INSTRUMENT CLASSIFICATION

1) Type of protection against electric shock: Class I equipment 2) Degree of protection against electric shock: Type BF applied part 3) Degree of protection against liquid penetration: IPO, ordinary equipment 4) Degree of safety of application in the presence of

flammable anesthetic: Not suitable equipment

5) Mode of operation: Continuous operation 3.5 STANDARDS COMPLIANCE

1) Safety: EN 60601-1:1990-08 + EN 60601-1/EC:1994-07 + EN 60601-1/A1:1993 + EN 60601-1/A1/Ec:1994-07 + EN60601-1/A2:1995-06 + EN60601-1/A13:1996-01

2) Electromagnetic Compliance: EN 60601-1-2:(2001) + EN 60601-1-2/Amend. 1:2004-09 + EMC Directive 89/336/EEC

3) Medical Instrument Directive (CE mark):

MDD 93/42/EEC (Notified Body 0123)

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3.6 DECLARATION - ELECTROMAGNETIC EMISSIONS

Guidance and manufacturer’s declaration – electromagnetic emissions The Easy on-Desk is intended for use in the electromagnetic environment specified below. The customer or the user of the Easy on-Desk should assure that it is used in such an environment. Emis sion test Compliance Electromagnetic environment –guidance

RF emissions CISPR11

Group 1

The Easy on-Desk 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 CISPR11

Class A The Easy on-Desk 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 Easy on-Desk is intended for use by healthcare professionals only. This Easy on-Desk may cause radio interferences or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Easy on-Desk or shielding the location.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

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3.7 DECLARATION - ELECTROMAGNETIC IMMUNITY

Guidance and manufacturer’s declaration – electromagnetic immunity The Easy on-Desk is intended for use in the electromagnetic environment specified below. The customer or the user of the Easy on-Desk should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment – Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 2 kV contact IEC 60417-5134 labeled

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 500.0 V for power supply lines ± 500.0 V for input/output lines

Mains power quality should be that of a typical commercial or hospital environment. It is further recommended that the Easy 0n-Desk be connected to a power network that is sufficiently filtered in regard to EFT.

Surge IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruption, and voltage variations on power supply input lines IEC 60601-4-11

< 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 Sample extinction

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Easy on-Desk requires continued operation during power mains interruptions, it is recommended that the Easy on-Desk be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

NOTE: UT is the A.C. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity

The Easy on-Desk is intended for use in the electromagnetic environment specified below. The customer or the user of the Easy on-Desk should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Easy on-Desk, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms d = 1.2√P

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m d = 1.2√P 80 MHz to 800 MHz

d = 2.3√P 800 MHz to 2.5 GHz

Where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in such frequency range.b 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. NOTE 2: These guidelines may not apply on all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Easy on-Desk is used exceeds the applicable RF compliance level above, the Easy on-Desk should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Easy on-Desk.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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3.63.8 RECOMMENDED SEPARATION DISTANCE - BETWEEN RF EQUIPMENT AND INSTRUMENT

Recommended separation distance between

portable and mobile RF communications equipment and the Easy on-Desk. The Easy on-Desk is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Easy on-Desk can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Easy on-Desk as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 1.2√P

80 MHz to 800 MHz d = 1.2√P

800 MHz to 2.5 GHz d = 2.3√P

0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3

10 3.8 3.8 7.3 100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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. NOTE 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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CHAPTER IV. PACKAGE CONTENTS

�

Your delivered Easy on-Desk Spirometer System shall consist of the following: No. Description Illustration i.

Easy on-Desk (One Set)

Main Unit:

ii.

Sensor Holder Assembly One (1) set

Accessory:

iii.

TrueFlow TM (One Set)

Flow Sensor:

iv.

SpiretteTM Tubes (Four Pieces)

Consumable:

v.

Thermal Recording Paper (One Roll) (P/N 150002)

Consumable:

vi. Nose-Clip (One Piece) (P/N ST003)

Accessory:

vii. Three (3) prong Power Cord (One Piece) (P/N ST004)

Accessory:

viii.

English Users Manual on CD: (One Set) (P/N 155113)

Accessory:

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12

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1

2

3

4

5

6 7

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CHAPTER V. PARTS IDENTIFICATION 5.1 Easy on-Desk MAIN UNIT

The color tones depicted in the following pictures may differ with the actual parts.

8

9

7

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Ref. No. Part Number Description

1 Liquid Crystal Display (LCD) 2 Power-On Indicator (blue) 3 Printer Cover 4 Paper Outlet 5 Printer Latch 6 Operational Keys 7 155111 (Optional) Flow Sensor Holder 8 Flow Sensor DB-9 Connectors 9 External Printer Connector 10 Power Switch 11 Serial Port Connector 12 Fuse Covers (250V T2A x 2) 13 AC Mains Connector

5.2 TrueFlowTM FLOW SENSOR

The color tones depicted in the following pictures may differ with the actual parts.

Ref. No. Part Number Description 1 Sensor Handle 2 SpiretteTM Tube 3 Data Cable 4 DB-9 Male Connector

Spirette Tube installed

2

1

4

3

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5.3 STANDARD CONSUMABLES

�

�

�

Operating the Easy on-Desk will require an ample supply of the SpiretteTM Tubes and Thermal Recording Paper as standard consumables. These standard consumables are supplied with this Spirometer upon initial purchase. The Built-in Printer will generally accommodate commercially available Thermal Recording Paper. To use a replacement consumable, ensure that the replacement Thermal Recording Paper smoothly feeds using a roll with a printing width of 50mm ~ 59mm and its full-roll diameter being able to fit the printer paper holder assessed by the free-rolling motion of the paper roll when the printer cover is flushed close.

Consumables

Always use consumables provided for exclusive use of this instrument. Using other than them may cause the instrument to fail or fulfill its function completely. Accredited consumables may be changed without notice for quality improvement.

CAUTION

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5.4 OPTIONAL ACCESSORIES

�

�

Your Easy on-Desk Spirometer may be fitted with optional accessories and consumables. Inquire with your local distributor for the available accessories adaptable to this instrument.

Accessories

Always use ascribed accessories, such as, attachments or spare parts, provided for exclusive use of this instrument. Using other than un-certified accessories may cause this instrument to fail or fulfill its function completely. Ascribed accessories may be changed without notice for quality improvement.

CAUTION

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5.5 OPERATIONAL KEYS LAYOUT

�

�

Alphanumeric characters are mapped to depending on the number of key presses made. Mapping selection moves in a circular motion.

Key Description

[0]-[9] Enter numbers and characters.

[ENT] Finish key input or select an option.

[CLR] Delete numbers, characters or measurement data.

[ID] Create a new patient record.

[VC] Display VC data and prepare for VC measurement.

[FVC] Display FVC data and prepare for FVC measurement.

[MVV] Display MVV data and prepare for MVV measurement.

[MENU] Display the Main Menu.

[BACK] Abort current function and return to previous screen.

[START] Start measurement, or finish the current function and proceed to the next screen.

[STOP] Terminate a measurement or abort the current function.

[PRINT] Print the current patient record.

[▲], [▼], [►], [◄]

Move the cursor or the selector bar.

KEYS Number of presses

1 2 3 4 5 [0] Space 0 [1] . , ` 1 [2] A B C 2 [3] D E F 3 [4] G H I 4 [5] J K L 5 [6] M N O 6 [7] P Q R S 7 [8] T U V 8 [9] W X Y Z 9

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CHAPTER VI. DISPLAY 6.1 PARAMETERS DEFINITION

Parameter Display Print Unit Std

Mai

n S

cree

n

Date of Measurement Room Temperature Patient Name Patient Number Age Height Weight Functional Residual Volume BSA Sex Race

MM/DD/YY HH:MM As entered ID# Age Ht Wt FRC Sex Race

MM/DD/YY As entered ID# Age Ht Wt FRC Sex Race (See Note b)

ºC (ºF) numeral years cm (ins) kg (lbs) L m2

√ √ √ √ √ √ √ √ √ √

FV

C S

cree

n

Forced Vital Capacity Forced Expiratory Volume at 0.5 Sec Forced Expiratory Volume at 1.0 Sec Forced Expiratory Volume at 3.0 Sec Forced Expiratory Volume at 4.0 Sec Forced Expiratory Volume at 5.0 Sec Forced Expiratory Volume at 6.0 Sec Ratio of FEV1/VC (T) Ratio of FEV1/FVC (G) Ratio of FEV3/VC (T) Ratio of FEV3/FVC (G) Maximal Mid-Expiratory Flow Expiratory Time Extrapolated Volume Forced Inspiratory Vital Capacity Forced Inspiratory Volume at 0.5 Sec Forced Inspiratory Volume at 1.0 Sec Ratio of FIV1/FVC Ratio of FIV1/FIVC Peak Expiratory Flow Mid (Forced)-Expiratory Flow at 75% Mid (Forced)-Expiratory Flow at 50% Mid (Forced)-Expiratory Flow at 25% Peak Inspiratory Flow Mid Inspiratory Flow at 50%

FVC FEV.5 FEV1 FEV3 FEV4 FEV5 FEV6 FEV1%T FEV1%G FEV3%T FEV3%G MMEF E Time V ext FIVC FIV.5 FIV1 /FVC /FIVC PEF MEF75%; (FEF25%) MEF50%; (FEF50%) MEF25%; (FEF75%) PIF MIF50%; (FIF50%)

FVC FEV.5 FEV1 FEV3 FEV4 FEV5 FEV6 FEV1%T FEV1%G FEV3%T FEV3%G MMEF E Time V ext FIVC FIV.5 FIV1 /FVC /FIVC PEF MEF75%; (FEF25%) MEF50%; (FEF50%) MEF25%; (FEF75%) PIF MIF50%; (FIF50%)

L L L L L L L % % % % L/sec seconds L L L L % % L/sec L/sec L/sec L/sec L/sec L/sec L/sec L/sec L/sec L/sec

√ √ √ √ √ √ √ √ √ √ √

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VC

Scr

een

Vital Capacity Expiratory Reserved Volume Inspiratory Reserved Volume Tidal Volume RR Expiratory Time (t, e) RR Inspiratory Time (t, i) RR Rate (f) RR Minute Volume (VE) RR Total Breathing Cycle Duration (t, tot) Ratio of TV/t, i Index of t, i/t, tot Functional Residual Capacity Residual Volume (see Note a) Total Lung Capacity (see Note a) Ratio of RV divided by TLC (See Note a)

VC ERV IRV TV te ti f VE tot TV/ti ti/tot FRC RV TLC RV/TLC

VC ERV IRV TV te ti f VE tot TV/ti ti/tot FRC RV TLC RV/TLC

L L L L seconds seconds breaths/min L/min seconds L/second index L L L ratio

√

MV

V

Scre

en Maximum Voluntary Ventilation

Respiration Rate Tidal Volume

MVV RR TV

MVV RR TV

L/min L/min L

√

Note a: Parameters are shown subject to FRC value availability. This Spirometer cannot measure FRC. FRC value in this instance

should be user-supplied. Note b: The Race parameter may be suppressed during printing by setting to OFF the RACE option under the Util-Print Mode

menu.

� � Parameters in parentheses can be modified in the System Mode - Para Menu.

� Parameters marked with “√” are routinely printed when Util-System Mode-Disp is set to “Standard” (ATS-format).

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6.2 FACTORY DEFAULT SETTINGS

Item Display Option Standard Predicted Equation Pred ECCS

SPAIN NORWAY (OSLO) FINLAND AUSTRIA ITS KNUDSON MORRIS-POLGAR CHILE JAPAN

√

Interpretation (See Note b)

Inte ITS ELLIS DIAGNOSIS GOLD

√

Data Select (See Note c)

Dsel ATS/ERS NIOSH

√

Reproducibility Select

Rsel ATS ERS NIOSH GOLD

√

Expiratory Flow Display Para MEFX FEFX

√

Unit of height/weight Unit Metric English

√

FRC Entry FRC OFF ON

√

Display item (see Note d)

Disp STANDARD CUSTOM

√

Language Lang ENGLISH GERMAN FRENCH SPANISH ITALIAN

√

ATS Acceptability Switch Accp OFF ON

√

Note b: When ITS interpretation is selected, the predicted equation in force is automatically set to ITS. Note c: The DSEL setting is associated only with the ITS or ELLIS interpretation algorithm. DSEL set to ATS uses only

parameters from the best measurement sample (maneuver) for the interpretations. While DSEL set to NIOSH/OSHA uses the best parameters from among the measurement samples acquired (not limited to the best measurement sample only).

Note d: When set to STANDARD, measurement parameters are displayed and printed in ATS-format. While in CUSTOM, measurement parameters are printed and displayed according to your personalized form. This is accomplished by setting-to ON each parameter in the Util-System Mode-Disp Menu. Once modified, the setting is in place except when changed. The default factory setting prints all the parameters when CUSTOM is selected.

� � Executing the System Init function sets this Spirometer into the factory default settings as shown by a “√” mark in the Standard column.

� Current settings are backed up by battery until modified.

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CHAPTER VII. CAUTIONS

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7.1 SAFETY INSTRUCTIONS FOR USE (1) Read and understand this User’s Manual carefully to operate this

instrument properly and safely. The instructions given should always be adhered to for safety importance.

(2) The instructions embodied within should be applicable to the safe operation and hazard prevention of Electromedical instruments.

(3) Do not repair or modify the instrument by yourself. No user-serviceable parts are included in this instrument. Your authorized local service personnel must do repairs only.

(1) Precautions For Use. � This instrument is a product dedicated to measuring human

pulmonary function (major tests, such as: vital capacity; forced vital capacity; and, maximum voluntary ventilation) and should not be used for other purposes. � Do not allow other than skilled persons to operate the instrument. � Read this User’s Manual carefully and completely and well

understand its contents before using the instrument. � Be careful not to subject this instrument to strong shocks not only

during operation, but also during transporting or storage. � Do not make adjustments or repairs by yourself other than that

specified in this User’s Manual. Should the instrument fail, mark as defective and contact our authorized service personnel in your area. � The user should never make modifications or alterations to this

instrument (including the software). Not only reliability will be compromised, but also the patient’s safety will be greatly endangered. � Only our authorized service personnel may open this instrument.

Possible risk such as, electric shock may result due to possible existence of a high voltage inside this instrument or an outright instrument failure may result. � Do not use other than our specified consumables to avert incorrect

measurement results or outright instrument failure. � Do not use portable or mobile Radio Frequency communications

equipment, such as: cell phones or the like, near the instrument. Possible instrument malfunction may result. � This instrument is intended for exclusive connection only to IEC/EN

60950-1 approved information technology equipment (ITE), such as data terminal and/or printer that can only be situated outside of the patient environment. For ITE class I equipment and isolated from the same protective earth as this instrument, the interconnecting ITE shall be supplied from a separated supply transformer. Should the ITE equipment not fulfill the above requirements where it is situated within the patient environment or not being IEC/EN 60950-1 approved, the instrument operator shall ensure that the resulting configuration complies with the IEC/EN 60601-1-1 standard

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requirement. (2) Power Connection � The supply voltage for this instrument should be within the specified

AC mains rating; else instrument failure or malfunction may result. � Use an isolated AC mains 3-hole socket inclusive of the ground return

path to plug your instrument’s power cord. � Avoid using common AC mains with noise-generating equipment.

Keep the instrument’s AC mains isolated from such equipment. � Do not use a power cord evident with stripped insulation or extreme

bending. If in doubt with the power cord insulation, contact our authorized repairman for inspection. � When plugging or unplugging the instrument’s power cord, do not fail

to hold unto the plug (and not on the cord). Possible breakage in the cord wires may result. � Plugging or unplugging the instrument’s power cord with wet hands

can cause a violent electric shock to you or persons close by. � Do not bend or twist the instrument’s power cord with undue force

nor place a heavy object on it to prevent insulation damage to the cord. This damage may cause an electric shock or give rise to a fire.

(3) Precautions For Installation � Using the instrument in the following environments will not only

impair the measurement reliability of the instrument, but also could affect instrument performance or an outright malfunction. Avoid placing the instrument in the following places: i) A place likely to be splashed with water. ii) A place exposed to direct sunlight. iii) A place directly exposed to the air blown from an air

conditioner or the like. iv) A place likely to be affected by vibration or impact. v) A place where temperature, humidity or atmospheric pressure

changes drastically. vi) A place likely to be adversely affected by an air containing

dust, salt, sulphur, etc. vii) A place where chemicals are stored or gases are produced. viii) A place where the ambient temperature is less than 10ºC or

exceeds 40ºC. ix) A place easily accessible to unauthorized users. x) A place where an equipment radiating strong magnetism,

electric wave, radio frequency waves, etc. is located. (4) Precautions Before Operation � Ensure all power and interface cable and its connections are correct

and safe before operating this instrument. � Inspect the instrument according to established routine and regular

inspection procedures making sure it operates normally. � Inspect any external equipment or attachments in accordance to their

accompanying instruction manual prior to interconnecting to this instrument.

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� Do not interconnect this instrument with other instrument without the proper expertise; else incorrect diagnosis or a hazardous accident may result. � Interconnect this instrument with other devices only in adherence to

the requirements of the IEC/EN 60601-1-1 standard. � Inspect the external equipment or attachments that is directly

connected to the patient for fault-inducing mistakes. � When moving the instrument, make sure that the flow sensor is seated

well in its receptacle and locked in position to prevent accidental dropping. � Use the instrument’s handle when carrying the instrument around

ensuring that the flow sensor is locked into its carrying position. (5) Precautions During Operation � This instrument is a class I internally powered instrument with a B-

type applied part complying with the EN 60601-1 safety standard. Do not use for other than its intended purpose of use. � As the instrument is not explosion-proof, do not operate in environs of

flammable gas such as anesthetic gas. � As the instrument is not cased airtight, do not use it in a place likely to

be splashed with water or where gases are produced. � Do not operate the instrument where the ambient temperature is under

10oC or over 40oC. � Do not expose the instrument to direct sunlight or subject it to

excessive vibration. � Do not overload any adapted AC mains socket by connecting multiple

loads that are beyond the AC socket’s carrying capacity. � Do not plug or unplug the power cord with wet hands to avoid electric

shock. � Use care not to exceed the measurement and assessment ranges of the

instrument. � Constantly monitor both the instrument and the patient for their

condition. Should any disorder be discovered, stop operating the instrument with the patient kept safe and take suitable measure. � Should any trouble occur with the instrument, immediately stop

operating the instrument; turn off the power; disconnect the power cord; mark as defective and contact our authorized repair representative in your area. � Use care to prevent the patient from accessing the control section of

the instrument. Measurement results will be affected or the patient’s safety may be compromised with this unauthorized action. � Do not operate the instrument in close vicinity to portable or mobile

Radio Frequency communications equipment, such as: cell phones or the like. Possible instrument malfunction may result.

(6) Precautions On Electrostatic Discharge � Electrostatic Discharge (ESD) is the transfer of electric charge

between bodies or objects of different electrostatic potential in proximity or through direct contact. This instrument uses electronic components that are susceptible to ESD. Do not operate this

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instrument in an area where there is insufficient ESD control. � Do not or cause yourself or your patient to touch or be in contact with

the instrument’s ESD sensitive connectors or where an adjacent ESD sensitive symbol are marked. � To minimize electrostatic build-up in your work-area, remove

unnecessary insulative materials, cut back on excessive rubbing movements with plastic, linen, and carpet materials, and dampen directly blown air from an air conditioner. � When the relative humidity is low, there is an increased risk of

electrostatic charging. Maintaining a relative humidity of 45% to 75% should be an ideal setting for mitigating electrostatic charge build-up and human physiological irritation due to ambient dampness. � Should the instrument operate in conjunction with other equipment,

ensure that ample grounding is in place for the instrument as well as for the other equipment sharing the work-area. � Never cut or bypass the ground-lug return of the instrument’s power

cord. Electrostatic build-up in the instrument can present a violent shock to the user or the patient. � There are no user serviceable parts in this instrument. Only our

authorized service personnel may open this instrument for servicing or repair. Possible risk of electrostatic discharge may cause an accident to personnel or an outright instrument failure.

(7) Precautions After Operation � Power off the instrument using its power-off switch before

unplugging the power cord. � When disconnecting the power cord, do not jerk it out of its AC mains

socket. Holding by its plug end, gently pull to disconnect. � Always remove contaminants from the instrument and keep it clean

for the next operation. (8) Precautions For Storage � Give ample attention to storage conditions since storing the

instrument in an unsuitable place may affect the instrument’s performance. � Avoid storing the instrument in the places mentioned in (3)

“Precautions for Installation”. � Prior to storage, clean the instrument and its accessories and put

together in proper order. (9) Maintenance And Inspection � Inspect the instrument, its accessories and components according to a

regular inspection procedure. � Before reuse of the instrument after an extended shutdown, make sure

it operates normally and safely. � Periodically conduct cleaning and disinfecting procedures of all

instrument parts before use. (10) General Precautions � When the instrument is moved from a cool to a warm place (such as a

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heated enclosure), water condensation may take place. Operating the instrument in such a condition may cause trouble thereto. In this case, wait for the instrument to dry before turning on the power. � Pay sufficient attention to safety when using the instrument in

combination with, or connecting it to other instruments. � After turning off the power, temporarily, wait 5 seconds or more

before turning on the instrument again. � Do not use the instrument close to an electrical utility room or in a

place where there is an X-ray or ultrasonic diagnostic equipment likely to generate noise. The instrument may fail to fulfill its original function. Operate the instrument isolated from such noise-generating equipment.

7.2 ELECTROMAGNETIC COMPATIBILITY This device has been proven to comply with EN60601-1-2 for Medical Electrical Equipment (under the Collateral Standard for Electromagnetic Compatibility- Requirement and Tests) in the Harmonized Standards. In order to further warrant a good level of electromagnetic immunity, it is suggested that the instrument be kept away from devices generating electromagnetic fields or interference such as loudspeakers, television sets, cellular phones, other telephone apparatus, or any similar devices. 7.3 HANDLING CONSUMABLES (1) Precautions for Handling. For the proper storage and handling of new and used Thermal Recording Paper, observe the following actions: � Keep away from direct sunlight and do not place it in an environment

where the temperature exceeds 60oC. This may result in the discoloration of the thermal paper. � Store in a place where prolonged exposure to fluorescent lighting is

avoided. � Store away from PVC films. � Prevent the contamination of new or unused thermal paper with used

ones. Make sure that they are stored separately. � Dispose used thermal papers properly.

For the proper storage and handling of new and used patient consumables, i.e., SpiretteTM Tubes, observe the following actions: � Store new and unused consumables in a clean hygienic container. � Do not place consumables in a damp storage place. � Never situate used consumable materials in close proximity to your

unused supply. � Immediately discard used or consumable materials according to your

local regulatory disposal statute.

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30

CHAPTER VIII. BASIC OPERATION

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8.1 ASSEMBLING THE INSTRUMENT

Location and Installation Locate this instrument on a clean surrounding by avoiding places of heavy ambient dusts, salts, and ions or likely to be splashed with water. Presence of such occurrence may lead to an excessive leakage current.

a. Unpack your Spirometer package and locate the Easy on-Desk Main

Unit, the TrueFlowTM Flow Sensor and the Sensor Holder Assembly.

b. The Sensor Holder Assembly is installed to the Easy on-Desk Main Unit by the following procedure:

� Unpack the Sensor Holder consisting of a metal cradle (1 piece),

rubber strap (1 piece), plate fastener (1-piece) and an M3 x 35 Screws (2-pieces).

� Stand the metal cradle on an upright position with its clamp arm by its right side.

� Thread the rubber strap from underneath the metal cradle’s clamp arm on through the slit leading the rubber strap over the cradle.

� Secure the rubber strap to the cradle with the plate fastener underneath the rubber strap.

� Insert the screws from under the plate fastener to align the three parts together.

� With the Main Unit on its front bottom side, set the Sensor Holder in a downside position over the hollow portion of the Main Unit’s bottom casing while aligning the screws.

� Tighten the screws to secure the Sensor Holder unto the Main Unit.

� Return the Main Unit to its upright position.

The Sensor Holder secures the TrueFlowTM Flow Sensor while not in use unto the Easy on-Desk Main Unit. This ensures safety from any dropping accident in case this Spirometer is to be moved around.

c. Unpack the TrueFlowTM Flow Sensor and interconnect its data cable

unto the allocated connector in the Easy on-Desk Main Unit located by its left side. Secure connection by tightening the connector’s locking screws.

WARNING

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The Easy on-Desk Main Unit Flow Sensor receptacle will only accommodate the supplied Flow Sensor data cable. This will prevent the inadvertent interconnection of similar serial cables.

d. Secure the TrueFlowTM Flow Sensor while not in use unto the Sensor

Holder by winding its data cable. Then with cable and Flow Sensor fastened unto the Sensor Holder by a Rubber Strap.

Cable Routing Properly arrange all interconnecting cables to avoid tripping that may result into this instrument dropping to the floor or cause an accident or injury.

8.2 READYING THE TrueFlowTM FLOW SENSOR

a. Lift the TrueFlowTM Flow Sensor by its handle and ensure its data cable is properly interconnected.

Handling

Do not immerse or allow water to splash over this instrument or any part thereof. Electronic parts inside the instrument when wet can present a violent electric shock to the user or the patient.

b. Inspect the mounted SpiretteTM Tube of the TrueFlowTM Flow Sensor using the following procedure.

• Hold the TrueFlowTM Flow Sensor

rigidly with its front (patient) side facing towards you;

• Grasp the installed SpiretteTM Tube and pull out until it clears the Flow Sensor;

• If replacement should be needed (inspecting for dirty , damped or damage tube), slide in the new SpiretteTM Tube until it sets rigidly unto the Flow Sensor.

WARNING

DANGER

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• Proper setting of the SpiretteTM Tube is ensured if its triangular key sits properly into the Flow Sensor detent.

c. Where an adapting in-line filter is used, consult your local distributor

for the recommended filters and procedures for use. 8.3 LOADING A THERMAL RECORDING PAPER The Thermal Paper is running short as soon as the marked red band is seen. In this case, promptly replace with a new roll of paper by these directions.

a. Release the Main Unit’s Printer Cover lock by depressing the Printer Latch (located at the right side). After which, lift the Printer Cover to its open position.

b. Place a good roll of Thermal Paper inside the compartment. Make

sure that the printing surface of the paper (shiny part) is against the printer side, and that the paper roll is cradled into the well with the loose end under the roll, and not the reverse (if the paper roll is placed incorrectly, no imprints will occur).

c. Pull enough slack of Thermal Paper to ensure that the paper roll may

be positioned perpendicular to the paper roller.

d. Close the printer cover by gently pressing it down.

e. To tear out paper, pull the paper against the printer edge (towards you).

Printer Handling Do not touch the paper cutter near the recording paper outlet for possible injury. Pay attention to the recording paper edges, as it may be sharp to cause possible injury.

If the Thermal Paper runs out while in the middle of printing data, printing continues from the point at which it has stopped.

CAUTION

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8.4 POWERING THE INSTRUMENT

a. Plug the Easy on-Desk using its three-prong power cord plug into a complementing AC mains socket. Place the instrument atop a steady table or platform with a level surface. A minimum of 10 cm clearance at the sides and rear should be observed.

AC Utility Connection Always plug the AC power cord in a medical 3-pin socket outlet of standard voltage. Never disconnect the plug’s ground lug to adapt connecting this instrument to a two-prong outlet. Improper grounding may cause accident such as electric shock.

b. Toggle the mains switch located at the right side of the Main Unit from the side marked “�” to “|” .

This Spirometer is fitted with line fuses for AC fault protection. If the instrument is unable to turn on, check for a blown fuse and replace. Turning the fuse covers counter clockwise will gain access to the fuses. Make sure that the Power Cord is disconnected from the AC lines when conducting fuse replacement.

c. Upon switching on, the Spirometer’s logo screen (containing the software version and model information) will be displayed with the power-on indicator lighted up.

The date and time screen will appear if no date and time was previously set into the Spirometer, as maybe the case of a newly purchased unit.

WARNING

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d. After displaying the logo display, the Spirometer displays the “Block Spirette” screen. This will require you to block with your palm one-end of the TrueFlowTM flow Sensor and depress the [START] key when ready.

e. The message “Flow Base Detecting…” then displays while performing zero baseline detection.

While the Spirometer performs flow base detecting, keep the TrueFlowTM Flow Sensor covered with your hand.

If the flow base detection routine fails, the Spirometer displays an error message signifying that the Spirette Tube may have not been properly installed, missing or an air draft sensed.

f. The user may elect to override the error, by entering the [ENT] key leading to the Main Menu display. All measuring capability of the Spirometer is however inhibited and only the Database & Utility functions available.

g. Or, the user may repeat the start-up sequence by powering down and then powering –up the Spirometer.

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For a successful flow base detection and calibration check has not been performed for the day, Calibration Check is requested. The user may perform or skip the test as your facility may require.

h. The Main Menu displays provided the baseline setting procedure was performed successfully.

i. It is extremely important to explain or demonstrate the correct breathing maneuver to the patient and have the patient do some trial runs in order to obtain the best test result.

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Take Patient Data

PerformMeasurement

Generate Report

Archive Data

Start

End

CHAPTER IX. OPERATION

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9.1 GENERAL OPERATING FUNCTION

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Press [ID ] forNEXT patient

test ing

Select [Mode] forMeasuring Mode

Press [START]to Re-measure

Press [MAIN]for Main Menu

Start

SwitchON

Start-up SequenceMain Menu

Input Patient Information

Select Measuring Mode[VC], [FVC] or [MVV ]

Patient Ready[START] to Measure

Perform Measuring ModeMANEUVER

Graph Display[STOP] to End Measurement

Review Acquired Data[UP] or [DOWN] for Data Display

Print Report[PRINT ] for Hard copy

Save DataDbase [SAVE] - function

SwitchOFF

End

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9.2 DETAILED OPERATING SEQUENCE

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9.3 MAIN MENU SCREEN After a successful start-up routine, the Easy on-Desk displays the Main Menu signifying that your Spirometer is now ready for operation.

Main Menu screen upon the initial start up. The Main Menu serves as the main or default screen.

The upper most part of the Main Menu displays the system date and time and the current operating mode. The operating mode is enclosed in brackets [ ], and may either be Baseline [BL] , Post [PO] or Bronchial Challenge [BC]. The patient information window is also shown and the numbered system sub menus at the bottom.

Refer to the Util-System Date Menu on how to set date and time.

Refer to ID function on how to enter patient data.

An asterisk ( * ) would initially appear beside the operating mode if the current record has already been edited since it was last saved. A question mark ( ? ) would appear if the record being edited has never been saved.

If no patient record has ever been created yet, the following default values for the current record are displayed inside the main box:

•ID - 0000000001 • Name - blank • Temp – Recorded Ambient or 37ºC / 98ºF • Age - blank • Ht - blank • Wt - blank • FRC - blank • Sex - Male • Race - White

The sub-menu/function(s) available under the Main Menu are enumerated at the bottom of the screen. These are:

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[1] Dbase - Editing, loading, deleting or saving a patient record, or printing a database listing;

[2] BC - Bronchial Challenge testing. The BC function is disabled (menu item is enclosed in parenthesis) if the system is already in POST mode, or if there is no FVC data associated with the current patient record;

[3] Post - Post Bronchodilator testing. The Post function is disabled (menu item is enclosed in parenthesis) if the system is already in BC mode, or if no VC, FVC or MVV data associated with the current patient record; and,

[4] Util – Sets the system mode, calibration factors, data transmission, print mode, system date/time and LCD contrast.

Use the [� / �] key to initiate any of the sub-menu function and press [ENT] or simply key in the item number. Or Press [ID], [VC], [FVC], or [MVV] key to go to another menu/function. Hot keys The following keys serve as short cut keys to their functions (except when in locked modes especially when taking measurements):

[ID]—to create new patient data; [MAIN ]—to return to Main Menu; [BACK ]—to return to previous menu; [PRINT]—to print the current patient information and data. With the [STOP] key to abort printing; [VC]—to start VC measurement (not accessible in BC mode); [FVC]—to start FVC measurement; and, [MVV ]—to start MVV measurement (not accessible in BC mode).

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CHAPTER X. PATIENT INFORMATION ENTRY

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This menu allows you to encode a patient’s information such as a patients’ identification number, name, the room temperature, and demographic data (age, height, weight, sex and race), and an FRC value (when enabled).

The patient’s demographic data is required to enable the Spirometer to display and print the patient’s predicted values and thus also perform proper interpretation.

Entering Patient Information Press [ID] key.

Typical patient information entry screen with default values. The ID Auto-increment feature of this model mechanically increments the ID numbering assignment (upon pressing the ID key), provided the current patient record is saved into the database. This feature gives more consideration to the database numbering control. Derivation for ID numbering increment is based on the succeeding available number reckoned from the highest assigned number in the database (not on the currently displayed ID number). 1. Use the [� / �] keys to browse through the field values and press the

[ENT] key to select the field.

For age, height, weight, and FRC fields, pressing the enter key will display the acceptable number range. (See Util-System Mode-FRC Menu for instructions on how to turn the FRC values display on and off).

2. Within the field, use the [CLR] key to delete characters, and use the [� /

�] keys to move the cursor.

Within a string or numeric field, use the [CLR] key to delete characters,

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and use the [ƒ / „] keys to move the cursor. Using the [CLR] key to cancel a selection prevents the cursor from moving on to the next field.

3. In entering into the patient name field, use the alphanumeric keys to input

patient name and the [CLR] key to delete existing values. After completion, press the [ENT] key again to confirm. The cursor then moves to the next field.

When a key-entry is made into an alphanumeric field, tThe number [0] – [9] keys can be used to input both alphabetic (A – Z, space, period, comma and apostrophe) and numeric characters. Press a given key once, twice or thrice within the time limit (at most 1 sec in-between successive key presses) to choose a character corresponding to a key.

4. Press the [START] key to create a new baseline record and return to the

Main Menu. Or Press the [ID], [VC], [FVC], [MVV] or [MAIN] key to go to another menu/function without saving the newly entered field values. Or Press the [ID] key to clear the recent values entered and creates a new ID entry.

If there is an existing ID entry with unsaved measurement data, a message prompt will appear to inquire whether or not to save the data. The prompt also informs the command keys.

5. Press the [ENT] key to save the current patient

data and proceed to ID or load function. Or Press the [START] key to proceed to the ID or (data) Load function without saving the current patient data. Or Press the [STOP] key to cancel ID or (data) Load function and go back to the previous screen.

ID Fields Details ID – Composed of ten digits. The ID field value is automatically set, by

default, to the lowest available ID number. Name – Maximum of twenty (24) alphanumeric characters.

Refer to the Operational Keys page for alphanumeric key functions.

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Temp (Temperature) – Acceptable range is from 10ºC to 40ºC (50ºF to

104ºF). The TrueFlowTM Flow Sensor periodically records the prevailing ambient temperature.

Unit for this parameter may be set to Centigrade or Fahrenheit. See Util -System Mode-Temp Menu to set accordingly. The prevailing unit for measurement will be applied on all the measurement data. When the unit of measurement is altered, conversion is automatically implemented.

Age – Acceptable range is from 1 to 99 years. Use the number keys to input

age. Ht – (Height) Acceptable range is from 90 to 220 cm (35 to 87 in). Use the

number keys to input height.

Unit for this parameter may be set to Metric (centimeters and kilograms) or English (inches and pounds). See Util-System Mode-Unit Menu to set accordingly. The prevailing unit for measurement will be applied on all the measurement data. When the unit of measurement is altered, conversion is automatically implemented. If you input a number that is not within the acceptable range, the minimum or maximum number (whichever is the nearest value) will automatically be entered.

Wt – (Weight) Acceptable range is from 10 to 220 kg (22 to 485 lb). Use the

number keys to input the weight of the patient.

Unit for this parameter may be set to Metric (centimeters and kilograms) or English (inches and pounds). See Util-System Mode-Unit Menu to set accordingly. The prevailing unit for measurement will be applied on all the measurement data. When the unit of measurement is altered, conversion is automatically implemented. If you input a number that is not within the acceptable range, the minimum or maximum number (whichever is the nearest value) will automatically be entered.

Sex – Choice between Male and Female. Use [� / �] keys to select and

press [ENT] or the corresponding number hot key for Male [1] and Female [2].

FRC (Functional Residual Capacity)– Acceptable range is from 0.01 to 5.00

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L (liters).

If the current FRC value is a whole number, pressing the [1] key once enters the digit ‘1’, while depressing the [1] key twice within 1 second enters a decimal point. On other hand, if the FRC value is fractional, pressing the [1] key always enters the digit 1. If the entered value is a whole number when the [ENT] key is pressed to exit the FRC field, the FRC value will automatically be converted to a floating point with two decimal places containing zeros. If the FRC value entered contains more than two decimal places when the [ENT] key is pressed, the FRC value will automatically be truncated to two decimal places.

Race – Choice among White, Black or Others. Use [� / �] keys to select

and press [ENT] or the corresponding number hot key for White, Black, or Others.

For the numeric data field (Temp, Age, Ht, Wt, FRC), digits are aligned to the right. The starting position of the cursor is always at the rightmost side of the field input box. The cursor will not move as you input or delete digits. When deleting a digit, the removed digit is the digit before the cursor. Patient ID 0000000000 This patient ID number has been pre-assigned for “PWG Testing Only”. DO NOT USE THIS NUMBER FOR ACTUAL PATIENT TESTING, as its captured data will be out of specifications. Measurement data acquired using this ID number is not adjusted for airflow viscosity correction. Use only for controlled signal sources such as a Pulmonary Waveform Generator Simulator or calibration syringe.

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CHAPTER XI. MEASURING MODES

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11.1 SETTING-UP VC, FVC, MVV, POST and BC Tests Important reminders before performing the pulmonary tests: Explain to the patient what a Spirometer will measure. A Spirometer is used to assess lung function. To make the patient simply understand, its purpose is to measure how hard and how fast one can breathe and how much air is in the lungs. If properly performed the test results can provide your respiratory practitioner the correct information. Direct the patient to: o Remove or loosen restrictive clothing such as tight collars or necktie. o Situate the patient in front of the Spirometer in a sitting or supine position. o Elevate chin and extend neck slightly. o To exert their full effort to comply with the vital breathing maneuver. Demonstrate the procedure yourself: o Place mouth tightly around the Paper Mouthpiece. o Do not block the opening of the mouthpiece with your tongue. o Perform the requisite breathing maneuvers for VC, FVC and MVV tests. o After the maneuver, pull away from the mouthpiece.

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11.2 VITAL CAPACITY - [VC] This measuring mode carries out Vital Capacity testing for patients. Press the [VC] key to enter this testing mode. (This function is not accessible during Bronchial Challenge mode.)

The VC table will be displayed.

The Mode indicator shows the current operating set-up as in Baseline [VC] or in POST [VC-Post]. The VC data is listed from oldest (first row) to the most recent data (third row). The best VC sample that has the highest VC value is marked with a , the second best sample is marked with a , and the third best sample is marked with a . If there is no recorded measurement data, the table will be empty. When recorded measurement data are present, the reproducibility validation notice may appear at the lower screen according to the following conditions:

a. The “ATS Reproducible” message displays when the RSel switch in the System Mode Function (Util-System Mode-Rsel) has been set to “ATS”, there exist three (3) measurement samples, and the difference of the best and second best VC values among the samples are not more than ±200 ml;

b. The “ERS Reproducible” message displays when the RSel switch in the System Mode Function (Util-System Mode-Rsel) has been set to “ERS”, there exist three (3) measurement samples, and the difference of the best and second best VC values are not more than ±100 ml or ±5%, whichever is greater.

If the table has entries, use the [� / �] keys to move the selector bar. Press [CLR] to delete the currently highlighted value, and follow the instruction of the delete prompt that will be displayed after.

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Upon deletion, the remaining data rankings will be updated. You can proceed to other menus or another function from this window by pressing the corresponding function keys: [FVC], [MVV], [ID], or [MENU]. Or Press [ENT] to go to the VC Data of the selected sample, if any. Or You can proceed with the measurement. VC MEASUREMENT PROPER 1. Secure the mouthpiece and the nose clip into the patient. 2. Press the [START] key to initiate VC measurement.

The VC measurement (Time-Volume) screen will be displayed.

Normal Magnified From this screen, use the [ENT] key to toggle magnification of the Volume-Time scale from 5L to 10 L and vice versa.

3. Instruct the patient to breathe normally to capture Tidal Volume (TV) measurement data. The actual VC measurement starts after the patient’s has conducted at least three stable TV breathing cycles. The start of actual capture of VC measurement is signaled by the “beep” sound.

The respiration waveform will be displayed as the measurement is being conducted.

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4. After the TV maneuver, immediately instruct the patient to breathe in to

the fullest, and breathe out completely without force. Resume normal breathing afterwards.

5. Press [STOP] to end measurement before the time limit is reached;

otherwise the measurement will terminate at the measurement capture time limit (60 seconds).

After measurement and when the Accp switch in the System Mode Function (Util-System Mode-Accp) has been set to “ON”, an ATS Acceptability validation notice displays should any of the following artifacts exist:

• When a cough is detected within the duration of the maneuver;

• There is a physical leak in the Spirometer blow stream; • Breathing hesitation during the maneuver that caused a cessation of

airflow; • The maneuver lasts less than six (6) seconds; or • No flow data plateau established in the volume-time curve at the

maximal inspiratory or expiratory volume as defined by no change in volume greater than 30 ml for at least one (1) second.

The result of the measurement is then displayed and returned to the VC table screen. (See VC table screen above for details)

6. Press [START] again if the VC measurement just performed is not

satisfactory.

A blank VC measurement screen will be displayed. 7. Press the [BACK] key to cancel the VC measurement and return to the

previous screen.

The prior VC table screen will be displayed.

Repeat the VC measurement as necessary (proceed from step 1 onwards).

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8. From the VC table screen press [ENT] to access the VC data window.

The VC data screen will be displayed. Press [� / �] keys to view all data entries. Press [PRINT] for printed results of selected VC data screen. Press the [START] key to conduct a new VC Measurement. Or Press the [BACK] to return to the previous screen (VC table screen). Or Press the [VC] key to go back to the VC Function. Or Press the [ID], [FVC], [MVV] or [MENU] key to go to another menu/function.

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11.3 FORCED VITAL CAPACITY - [FVC] This measuring mode carries out Forced Vital Capacity testing to patients. Press the [FVC] key to enter this testing mode.

The FVC table will be displayed.

The Mode indicator shows the current operating set-up as in Baseline [FVC], in POST [FVC-Post], or in BC [FVC-BC]. The VC data is listed from oldest (first row) to the most recent data (third row). The FVC data is listed from oldest (first row) to the most recent data (third row). The best FVC sample that has the highest (FVC + FEV1) value is marked with a , the second best sample is marked with a , and the third best sample is marked with a . If there is no recorded measurement data, the table will be empty. When recorded measurement data are present, the reproducibility validation notice may appear at the lower screen by the following conditions:

a. The “ATS Reproducible” message displays when the RSel switch in the System Mode Function (Util-System Mode-Rsel) has been set to “ATS”, there exist three (3) measurement samples, and the difference of the best and second best FVC and FEV1 values among the samples are not more than ±200 ml;

b. The “ERS Reproducible” message displays when the RSel switch in the System Mode Function (Util-System Mode-Rsel) has been set to “ERS”, there exist three (3) measurement samples, the difference of the best and second best FVC and FEV1 values are not more than ±100 ml or ±5%, whichever is greater, and the difference of the best and second best PEF values are not more than ±10%.

c. The “NIOSH Reproducible” message displays when the RSel switch in the System Mode Function (Util-System Mode-Rsel) has been set

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to “NIOSH”, there exist three (3) measurement samples, the difference of the best and second best FVC and FEV1 values are not more than ±100 ml or ±5%, whichever is greater, and the difference of the best and second best PEF values are not more than ±400 ml or ±10%, whichever is greater.

d. The “GOLD Compliant” message displays when the Inte switch in the System Mode Function (Util-System Mode-Inte) has been set to “GOLD”, there exist three (3) measurement samples, and the difference of the best and second best FVC and FEV1 values are not more than ±100 ml or ±5%, whichever is greater.

If the table has entries, use the [� / �] keys to move the selector bar. Press [CLR] to delete the currently highlighted value, and follow the instruction of the delete prompt that will be displayed after. Upon deletion, the remaining data rankings will be updated. You can proceed to the other menus or another function from this window by pressing the corresponding function keys: [VC], [MVV], [ID], or [MAIN] Or Press [ENT] to go to the FVC Data of the selected sample, if any. Or You can proceed with the measurement. FVC MEASUREMENT PROPER 1. Secure the mouthpiece and the nose clip into the patient. 2. Press the [START] key to initiate FVC measurement.

The FVC measurement (Time-Volume) screen will be displayed.

Normal Magnified

From this screen, use the [ENT] key to toggle magnification of the Flow-Volume scale.

3. Instruct the patient to breathe normally. The actual FVC measurement

starts after the patient’s has conducted at least a cycle of stable Tidal

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Volume breathing. The actual FVC measurement is signaled by the “beep” sound.

An animated respiration waveform that normalizes at the y-axis will be displayed as the measurement is being conducted.

4. Immediately instruct the patient to breathe in to the fullest, then breathe

out completely with force. Direct the patient to continually breathe out all the air past five seconds and then breathe in again to the fullest of full force and then return to normal breathing.

5. Press [STOP] to end measurement before the time limit is reached;

otherwise the measurement will terminate at the measurement capture time limit (30 seconds).

In the measurement result screen and when the Accp switch in the System Mode Function (Util-System Mode-Accp) has been set to “ON”, an ATS Acceptability validation notice displays should any of the following artifacts exist:

• When a cough is detected within or after the first second of expiration (beyond the FEV1 for flow-volume terminal anomalies as in when a patient takes in extra air near the maneuver’s end and then exhale this air);

• Extrapolated volume is greater than FVC by 5% or 0.15 L, whichever is higher; There is a physical leak in the Spirometer blow stream;

• Breathing hesitation during the maneuver that caused a cessation of airflow;

• The maneuver lasts less than six (6) seconds; • No flow data plateau in the volume-time curve as defined by any

change in volume greater than 30 ml for at least one (1) second.

The result of the measurement is then be displayed and returned to the FVC table screen. (See FVC table screen above for details)

6. Press [START] again if the FVC measurement just performed is not

satisfactory.

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A blank FVC measurement screen will be displayed. 7. Press the [BACK] key to cancel the FVC measurement and return to the

previous screen. The prior FVC table screen will be displayed.

Repeat the FVC measurement as necessary (proceed from step 1 onwards) 8. From FVC table screen press [ENT] to access FVC data window.

The FVC data screen will be displayed. Press [� / �] keys to view all data entries. Press [PRINT] for printed results of selected FVC data screen. Press the [START] key to conduct a new FVC Measurement. Or Press the [BACK] to return to the previous screen (FVC table screen). Or Press the [FVC] key to go back to the FVC Function. Or Press the [ID], [VC], [MVV] or [MENU] key to go to another menu/function.

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11.4 MAXIMUM VOLUNTARY VENTILATION - [MVV] This measuring mode carries out Maximal Voluntary Ventilation testing to patients. Press the [VC] key to enter this testing mode. (This function is not accessible during Bronchial Challenge mode.)

The MVV table will be displayed.

The Mode indicator shows the current operating set-up as in Baseline [MVV], or in POST [MVV-Post]. The MVV data is listed from oldest (first row) to the most recent data (third row). The best MVV sample that has the highest MVV value is marked with a , and the second best sample is marked with a . If there is no recorded measurement data, the table will be empty. If the table has entries, use [� / �] keys to move the selector bar. Press [CLR] to delete the currently highlighted value, and follow the instruction of the delete prompt that will be displayed after. Upon deletion, the remaining data rankings will be updated. You can proceed to menu or another function from this window by pressing the corresponding function keys: [FVC], [VC], [ID], or [MENU] Or Press [ENT] to go to the MVV Data of the selected sample, if any. Or You can proceed with the measurement. (see MVV measurement proper below)

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MVV MEASUREMENT PROPER 1. Secure the mouthpiece and the nose clip into the patient. 2. Press the [START] key to initiate MVV measurement.

The MVV measurement (Time Volume) screen will be displayed.

Normal Magnified From this screen, use the [ENT] key to change the Time-Volume scale display.

3. Instruct the patient to breathe in and out in a deep and rapid rhythm as in

one-two, one-two pattern.

The respiration waveform will be displayed as the measurement is being conducted.

4. Continue measurement until the time limit of twelve-seconds (12 sec), otherwise the measurement will terminate after the waiting time limit of ninety seconds (90 sec) has lapsed.

The result of the measurement is then displayed and returned to the MVV table screen. (See MVV table screen above for details). Termination of the MVV test due to expiration of the waiting time limit may result into under-estimation. To obtain a valid MVV data, ensure that the MVV maneuver was completed for a minimum of 12 seconds.

5. Press [START] again if the MVV measurement just performed is not

satisfactory.

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A blank MVV measurement screen will be displayed. 6. Press the [BACK] key to cancel the MVV measurement and return to

the previous screen.

The prior MVV table screen will be displayed. Repeat the MVV measurement as necessary (proceed from step 1 onwards) 7. From MVV table screen press [ENT] to access MVV data window.

The MVV data screen will be displayed.

Press [� / �] keys to view all data entries. Press [PRINT] for printed results of selected MVV data screen. Press the [START] key to conduct a new MVV Measurement. Or Press the [BACK] to return to the previous screen (MVV table screen). Or Press the [MVV] key to go back to the MVV Function. Or Press the [ID], [FVC], [VC] or [MENU] key to go to another menu/function.

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11.5 POST MEASUREMENT - [POST] This command will be enabled only when there is at least one VC, FVC or MVV measurement data. The requisite measurement data will serve as the baseline data or PRE data of the patient. Once post-measurement starts, you cannot return to baseline measurement until a new patient ID is invoked. The mode display will indicate the post measurement status. From the Main Menu press [3] or press [ENT] key when the Post Function is highlighted.

The prompt screen to confirm post mode activation will be displayed.

Press the [ENT] key to go into POST mode. The screen will automatically return to the Main Menu. Or Press the [BACK] key to cancel POST mode entry and return to the Main Menu.

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Conduct Post Measurement

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POST Data Series

POST Graphs Series

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Acquire VC/FVC/MVV Pre(baseline) data by:

direct measurement; or load fromdatabase

Administer BronchodilatorInhalations

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POST-BRONCHODILATOR TEST Illustrated steps in conducting actual Post Bronchodilator test. For single patient:

1) Perform VC, FVC, or MVV measurement on the patient and select the best data (Refer to VC, FVC, MVV test instructions). Use the acquired measurement as a baseline (PRE) data.

2) Administer the physician’s bronchodilator dose to the patient. 3) Go into Post Mode (Refer to the Post instructions above). 4) Post measurement maneuvers are the same as normal measurement

(VC, FVC or MVV). 5) Measurement data displayed in post-measurement includes the

currently measured value and the percentage improvement relative to the baseline (PRE) data.

6) Print or save the post-measurement data, as desired. For multiple patients:

1) For every patient, perform VC, FVC, or MVV measurement for baseline data and then save the acquired measurement data.

2) Administer the physician’s bronchodilator dose to each patient. 3) Load the current patient data for post-measurement. (Refer to the

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Dbase-Load Menu). 4) Go into Post Mode (Refer to the Post instructions above). 5) Post measurement maneuvers are the same as normal measurement

(VC, FVC or MVV). 6) Print or save the post-measurement data, as desired. 7) Repeat steps 2 through 6 for the other patients.

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11.6 BRONCHIAL CHALLENGE - [BC] The Bronchial Challenge (BC) test serves to identify the susceptibility of a patient to bronchial stenosis by inhalation of nonspecific irritants (Methacholine, Histamine, Antigens, etc.). While the FVC maneuver is used in BC testing, evaluation is made using the value of FEV1 for positive response to this test. This measurement applies a load to the patient. Therefore, a proficient medical specialist should always perform it. Resuscitation equipment and medications (bronchodilator) should be readily available during the course of this test. This test cannot be performed unless an FVC pre-measurement data baseline data has been established. Save the pre-measurement data should you require printing or for further use as baseline data. Once BC test starts, you cannot return to pre-measurement. From the Main Menu press [2] or press [Enter] key when the BC Function is highlighted.

The prompt screen to confirm BC mode activation will be displayed. Press the [ENTER] key to go into BC mode. The screen will proceed to BC set up screen. Or Press the [ESC] key to cancel BC mode activation. After completing BC test, a new patient record should be loaded (either by new patient entry or load from the database) to restore VC, FVC or MVV selections.

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BRONCHIAL CHALLENGE TEST PROPER 1) Perform FVC measurement on the patient and select the best data (pre

measurement data is obtained.). Use this best FVC acquired measurement as a baseline data and saving this as desired.

Omitting the archiving of your acquired measurement data will prevent printing the pre-measurement data after you have moved to BC testing).

2) Administer the physician’s Bronchial Challenge regimen to the patient. 3) Upon entry to the BC mode testing, the display proceeds to the BC

Protocol Menu. 4) Following a sequential order, select the administered medium and press

[ENT]. And depending on the selected step (Saline, Dosage, Dilator), the corresponding Data Table Screen is displayed. Note that the BC protocol step you are performing can be seen on the topmost display of the Data Table Screen.

Typical Dosage Table screen is displayed depending on a particular protocol steps. Note that the BC protocol step you are performing can be seen on the topmost display of the Data Table Screen.

5) When you initially enter the Dosage step in the BC Protocol menu, you

will be prompted for the provocative substance you used with the patient.

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6) Selecting a particular provocative dose substance, you will be led to the entry of the actual substance dose administered to the patient.

7) At each dosage, perform FVC maneuver and note for the indication. 8) Press either [BACK] or [STOP] key to conclude a measurement, and

return you to the Dose Data Table screen. While in the FVC mode, use the [� / �] key to display and inspect the acquired FVC data and waveforms (noting the notation [B] in the upper left hand corner signifying that this FVC measurement is done in BC mode).

9) Pressing [ESC] on the Dose Data Table screen returns you to the BC

Protocol Menu. 10) Repeat steps 2 through 8 to repeat the measurement.

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Conduct FVC Measurement

Administer Saline Inhalations

Start BC

Administer Provocative MaterialInhalations

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FVC-BC Data Series

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%FEV1 ≥80%

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StartBC Mode

Select "1. Saline" inBC Protocol Screen

BACK

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Dose-FVC Series Screen

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Select "2. Dosage" inBC Protocol Screen

Select Provocative Material1. Methacoline2. Histamine3. Antigen4. Custom

Enter Dose Registration ValuesBACK

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Dose-FVC Series ScreenDose-FVC Graphs

Select "3. Dilator" inBC Protocol Screen

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Dose-FVC Series ScreenDose-FVC Graphs

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1) Measurement with inhalation of diluents solution (SALINE ) The purpose of this step is to assess the presence of non-specific responses. The physician may opt to skip this step and proceed to the next (dosage). a) Administer the protocol of saline solution inhalations to the patient.

b) Perform FVC measurement.

2) Measurement with inhalation of provocative dose (DOSAGE)

This is the main routine for the challenge. After the patient inhales the provocative material, a corresponding FVC measurement is conducted. Thereafter, inhalation doses are increased according to a prescribed protocol and monitored through measurement for a positive provocative response. a) Administer the prescribed protocol of provocative agent to the

patient.

i) Dosage template available are: (1) Methacholine; (2) Histamine; (3) Antigen; and, (4) Custom.

Chose any by inputting the corresponding number or pressing [ENT] when the desired template is highlighted.

ii) The first three templates when selected automatically displays

pre-programmed concentration values. Follow the prompt instructions or use [� / �] keys to select desired value.

Typical dosage administration dialog menus.

The succeeding dosage concentration should be higher than the last. For a custom choice, one must input the numeric values of the concentration dosage administered.

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Refer to Appendix 3 for the table of inhalation units for Methacholine, Histamine, and Antigen templates.

b) Press [ENT] to register the keyed concentration value. You are returned to the Dosage Table screen if the entry is valid.

c) Perform the same measurement as a normal FVC measurement.

d) Increase the dose concentration as per the prescribed protocol and

repeat FVC measurement after each dose administration.

After conducting an FVC measurement, pressing [ENT] brings you to the FVC-BC data table and graphs. View the contents by using the [� / �] keys. While pressing the [BACK] key, returns you to the Dosage Table screen. In this screens you may view the BC time graphs for your inspection. Use the [► / ◄] to view the full graph in a scrolling manner.

e) When the FEV1% value decreases to 80% or less of the baseline

data set in (1), the following message appears on the LCD: FEV1 %BL = ×× %; and,

an asterisk symbol shall be displayed beside the corresponding dosage while in the dosage Table Screen.

f) As per the prescribed protocol, you may proceed to further dosage

and a measurement; or, proceed to measurement with inhalation of bronchodilator (Dilator Recovery).

3) Measurement with inhalation of bronchodilator (Dilator: RECOVERY)

After the challenge, administer bronchodilator to the patient for recovery. Perform measurement to confirm recovery. You can skip this measurement if unnecessary, but ensure that the patient inhale a suitable bronchodilator at the end of the test. a) Administer bronchodilator inhalations to the patient.

b) Perform the same measurement as normal FVC measurement.

c) For extended bronchodilator inhalations and further measurement,

repeat from step a).

d) STOP BC test by selecting the “Stop” selection in BC Protocol menu and the BC data comparison screen will be displayed. Use [� / �] keys to display graphs and other FVC-BC data screen, etc.

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Press [PRINT] key to print results. Depressing the [PRINT] key while in the Dosage Table screen will provide the data table screen and BC time series graph printouts. From the BC measurement mode create a new patient ID entry if you wish to perform a pre (VC, FVC, MVV) measurement. Save the BC measurement data through the Dbase Menu. If you were not able to save the data you can choose to save or not to save the BC data once you press the key to create new ID entry.

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CHAPTER XII. DATA STORAGE (Dbase)

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This function is used to access the internal database storage of this Spirometer. From the Main Menu press [1] or press [ENT] key when the Dbase option is highlighted. At the top of the screen is the menu name enclosed in a bracket “[DBase]” followed by “-*” or “-?” as an indicator, (see Main Menu for details). The following operations are available and accessed by pressing the corresponding number keys, or by pressing the [ENT] key when the option is highlighted.

Display Function 1. Edit Changes currently loaded patient information. 2. Load Loads a stored patient data. 3. Del Deletes a stored patient data. 4. List Automatically prints all patient data saved 5. Save Stores current patient data to database.

Select the corresponding display function. Or Press [BACK] to return to the Main Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] key to go to another menu/function. This Spirometer has a database capacity limit to store patient records inclusive of information and measurement data.

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12.1 PATIENT DATA EDITING - [1. Edit] This command converts the ID information window into editing mode. It is however, disabled/inaccessible if POST or BC mode is activated. From the Dbase Menu, press [1] or [ENT] when the Edit option is highlighted. Refer to the ID Menu for specific instructions on how to input ID information entries.

An asterisk (-*) would initially appear beside the function name if the current record has already been edited since it was last saved. A question mark (-?) would appear if the record being edited has never been saved.

Press [START] to save edited data and go back to the DBase Menu. Or Press [BACK] to cancel record editing and go back to the DBase Menu Or Press [ID], [VC], [FVC], [MVV] or [MENU] key to go to another menu/function without saving newly entered values.

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12.2 PATIENT DATA LOADING - [2. Load] This command provides access to the stored patients records. From the Dbase Menu, press [2] or [ENT] when the Load option is highlighted.

The load window will be displayed. The upper box contains the ID number, record type, i.e., [BL], [PO], [BC]; creation or modification date (in MMM/DD/YY format); and, time (in HH:MM 24-hour format) of the record whose patient name is highlighted.

The lower box contains the sorted list of patient names. Patient records are sorted alphanumerically by Name. If there were an occurrence of identical Names, records would then be sorted according to type. It would be arranged in such a manner that the baseline record of a particular patient would precede his POST record, while his POST record would precede his BC record.

Use the [� / �] keys to select the record to be loaded. As the selector bar navigates through the sorted list of patient Names, the ID, record type and the creation/modification date and time shown in the upper box changes with the currently highlighted record. The screen can only display a maximum of seven (7) patient Names at one time. Instead of using the [� / �] keys, the selector bar may also be made to jump to a particular record via a record search. Record search is initiated by entering a character enabling the display of subsequent records starting from the entered character. Press [ENT] to set the selected (currently highlighted) record as the new current record and go back to the DBase Menu. Or Press [BACK] to cancel record loading and go back to the DBase Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without loading a new patient record.

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12.3 PATIENT DATA DELETING - [3. Del] This command provides you the option to delete stored patient data. From the Dbase Menu, press [3] or [ENT] when the Del option is highlighted.

A message prompt that inquires whether you wish to delete selected data or all of the listed data will be displayed.

Press [1] to delete selected data. Or Press [2] to delete ALL data. Any subsequent record(s) following the deleted record in the circular list would be shifted one record up if the deleted record is a POST record, BC record or baseline record without any record link. On the other hand, if the deleted record were a baseline record with link(s), the actual number of records deleted would shift up the number of deleted record(s) that follow. The record number of the record(s) that follow the deleted record(s) in the sorted list is/are updated since the record count has changed. Instead of using the [� / �] keys, the selector bar may also be made to jump to a particular record via a record search (see the Load Function). Single Record Deletion

Once the Delete Select [1] command is initiated, the list of stored patient record(s) will be displayed.

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Use the [� / �] keys and then press [ENT] to confirm the particular record for deletion. The ID, record type and creation/ modification date and time displayed in the upper box changes as the selector bar moves from record to record. When a record is deleted, it is immediately taken out of the display list. A message prompt to confirm the record deletion will appear.

Press [ENT] to proceed with the deletion Or Press [STOP] to cancel and return to previous window. Multiple Record Deletion

If the selected record is a baseline record with POST and/or BC links, the following message prompt will appear.

Press [ENT] to proceed with the deletion. After deletion the screen will return to the Delete-Selection [Del-Sel] function if record(s) still remain in the patient database; or return to the Main Menu if no record remains. Or Press [STOP] to cancel and return to the previous window. Delete All Records

Once the Delete All [2] command is selected from the Del Menu, a message prompt to confirm deletion of all data will appear.

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Press [1] to proceed with all data deletion Or Press [BACK] to abort and return to Del Menu.

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12.4 PATIENT DATA LISTING - [4. List] This function generates and prints list of basic patient information. From the Dbase Menu, press [4] or [ENT] when the List option is highlighted.

The “Printing…” message is at the center of the screen while data for each record in the patient database is being sent to the internal printer.

Below is an example of printed database listing.

The list contains the following information. Record number --indicates the sorted order of the given record in the

patient database. ID/Name - Patient ID# and name. Record type - set to “Base” if the given record is a baseline record;

“POST” if the given record is a POST record; or, “BC” if the given record is a BC record.

Patient’s sex--set to ‘M’ if the patient is male or ‘F’ if the patient is female.

Patient’s age--indicates the patient’s age in years. Record date -indicates the creation or modification date, in the

MMM/DD/YY format, of the patient record. The screen automatically goes back to the DBase Menu when all records in the patient database have been sent to the printer.

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12.5 PATIENT DATA SAVING - [5. Save] This function saves the current patient data into the database. From the Dbase Menu, press [5] or [ENT] when the Save option is highlighted.

The “Saving…” message is at the center of the screen while the current record and/or its baseline are/is being uploaded to the patient database.

Only one (1) record would be saved in the database if the current patient record is a: (1) Baseline record with no existing POST or BC record link; (2) Baseline record that has existing record link(s) but has: � Not had its patient ID changed; or, � Had its patient ID changed and the user chooses to create a new record);

(3) POST or BC record that does not contain measurement data and whose baseline has:

(4) No existing link; or, (5) Existing record link(s) but has: � Not had its patient ID changed; or, � Had its patient ID changed and the user chooses to create a new record

(see Create New Record Message); Or POST or BC record whose baseline has not been changed or edited since it was last saved. Two (2) records would be saved in the database if the current patient record is a: Baseline record that has only either a POST or BC record link and has had its patient ID changed, and the user chooses to overwrite the existing baseline record and its link in the patient database (see Create New Record Message); POST or BC record that does not contain measurement data and whose baseline has only either a POST or BC record link and has had its patient ID changed, and the user chooses to overwrite the existing baseline record and its link in the patient database (see Create New Record Message); or, POST or BC record that contains measurement data and whose baseline has:

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a. Never been saved; or, b. Been changed or edited since it was last saved and has:

i. No existing POST or BC record link; or, ii. Existing record link(s) but has:

1. Not had its patient ID changed; or, 2. Had its patient ID changed and the user chooses to:

a. Create new records; or, b. Overwrite the existing baseline record and

a link of the same type as the current patient record (see Create New Record Message).

Three (3) records would be uploaded to and saved in the database if the current patient record is a: Baseline record that has both POST and BC record links and has had its patient ID changed, and the user chooses to overwrite the existing baseline record and its links in the patient database; POST or BC record that does not contain measurement data and whose baseline already has existing POST and BC record links and has had its patient ID changed, and the user chooses to overwrite the existing baseline record and its links in the patient database; or POST or BC record that contains measurement data and whose baseline already has an existing record link of a different type and has had its patient ID changed, and the user chooses to overwrite the existing baseline record and its link(s) in the patient database (see Create New Record Message). When a record is uploaded to and saved in the patient database, its creation or modification date and time is set or updated accordingly.

Patient records with no acquired measurement data will not be saved. When saving beyond the database capacity, delete unnecessary data beforehand.

The screen automatically goes back to the DBase Menu when the current record and/or its baseline data has /have had been saved to the patient database.

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CHAPTER XIII. PRINTING INTERNALLY (Print)

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Press [PRINT] to activate printing mode.

The current software version that issued the report is depicted in the report headings and is formated as V99-99 represented as 99 for a major change that has an effect on the applicable (display and print) outputs, while –99 is for a minor change that has no adverse effect on the applicable outputs.

13.1 BASELINE DATA PRINTING

While in any of the Measurement Modes (VC, FVC & MVV), depressing the [PRINT] key will print the current patient measurement data that is currently on display. The printing format and the printing device selection shall follow the settings made under the Util-Print Mode menu.

Typical Baseline VC Standard printout on the Internal Printer…

Typical Baseline VC Custom printout on the Internal Printer…

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Typical Baseline FVC Standard printout on the Internal Printer… Typical Baseline FVC Custom printout on the Internal Printer…

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Typical Baseline MVV Standard printout on the Internal Printer… Typical Baseline MVV Custom printout on the Internal Printer…

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13.2 PRE/POST DATA PRINTING

While in the Post-Measurement Mode (VC, FVC or MVV), depressing the [PRINT] key will print the current patient measurement in the following format. The printing format and the printing device selection shall follow the settings made under the Util-Print Mode menu. Typical Pre/Post VC Standard Measurement printout on the Internal Printer… Typical Pre/Post VC Custom printout on the Internal Printer …

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Typical Pre/Post FVC Standard printout on the Internal Printer …

Typical Pre/Post FVC Custom printout on the Internal Printer …

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Typical Pre/Post MVV Standard printout on the Internal Printer … Typical Pre/Post MVV Custom printout on the Internal Printer …

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13.3 BRONCHIAL CHALLENGE DATA PRINTING

While in the BC Measurement Mode (FVC), depressing the [PRINT] key will print the current patient measurement in the following format. The printing format and the printing device selection shall follow the settings made under the Util-Print Mode menu. Typical Standard BC measurement printout on the Internal Printer … Typical Custom BC Measurement printout on the Internal Printer …

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On every Dose column of the BC printout, an asterisk precedes parameter values satisfying the following criteria:

Parameter Reduction from baseline

FVC 10% FEV1 20%

MMEF 25% PEF 25%

MEF50% 25%

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13.4 CALIBRATION CHECK DATA PRINTING

Depressing the [PRINT] key after Calibration Check routine will print instead the implemented correction factor.

Typical Calibration Check printout on an Internal Printer. The report contains the previous and the just concluded performance indexes including its date and time stamp to provide the user a historical accuracy state.

When the selected printer is not ready, the user is prompted to correct the fault to resume printing. To cancel printing, press the [STOP]. If the recording paper runs out while in the middle of printing data, printing resumes from the point at which it has stopped. While printing and a measurement (VC, FVC, or MVV) mode is concurrently running, pressing the [STOP] key will give termination preference to the measuring mode. Subsequent depression of the {STOP} key will halt printing.

Printer Handling Do not touch the paper cutter near the recording paper outlet for possible injury.

To print from the top, press the [STOP] key first and then the [PRINT] key. Or, Turn off and then on the Spirometer. When the Main Menu displays, press the [PRINT] key.

CAUTION

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CHAPTER XIV. PRINTING EXTERNALLY (Print)

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In directing your print output to an external printer device, consult our authorized distributor for the accredited external printer models that may be interconnected to this Spirometer.

Options Accredited optional parts may be changed without notice for quality improvement.

Do not use other than the ascribed External Printer Cable to interconnect your accredited external printer to this Spirometer. Possible fault or hazard may result.

Check for proper connection of the External Printer Cable between this Spirometer and the external printer device should communication failure occurs.

Electrostatic Discharge A violent electric shock may result when accumulated electrostatic discharges. Do not touch or cause contact with ESD sensitive device (connectors).

When physically connecting the External Printer Cable, do not touch or cause contact with the Spirometer’s External Printer Port Connector or any part thereof for ESD protection.

Press [PRINT] to activate printing mode.

CAUTION

CAUTION

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14.1 BASELINE DATA PRINTING

While in any of the Measurement Modes (VC, FVC & MVV) and the selected Printer (under Util-Print Mode) is set to External, depressing the [PRINT] key will print the current patient measurement data that is currently on display. Typical Standard & Custom VC, FVC and MVV printout on an External Printer…

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14.2 PRE/POST DATA PRINTING

While in the Post-Measurement (VC, FVC or MVV) Mode, and the selected Printer (under Util-Print Mode) is set to External, depressing the [PRINT] key will print the current patient measurement in the following format. Typical Standard and Custom Post-Measurement VC, FVC and MVV printout on an External Printer…

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14.3 BRONCHIAL CHALLENGE DATA PRINTING

While in the BC Measurement (FVC) Mode, and the selected Printer (under Util-Print Mode) is set to External, depressing the [PRINT] key will print the current patient measurement in the following format. Typical Post-Measurement VC, FVC and MVV printout on an External Printer…

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When the selected printer is not ready, the user is prompted to correct the fault to resume printing. To cancel printing, press the [STOP].

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CHAPTER XV. UTILIY (Util)

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This menu manages the different support functions available by setting of the system’s operating modes; provision for data uploading transmission; printing options; adjusting the system date; and, affixing the display contrast. From the Main Menu press [4] or press [ENT] key when the Util option is highlighted. To select the desired function, use [� / �] keys, and to initiate operation, press the [ENT] key or simply key in the item number. Submenus of the Utility function are:

Display 1. System Mode 2. Transmission 3. Print Mode 4. System Date 5. LCD Contrast

Select the desired function by pressing the corresponding number keys. Or Press [BACK] to return to Main Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] key to go to another menu/function.

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15.1 OPERATING SETTINGS - [1. System Mode] This function is used for setting the global parameters required to properly present the captured patient data. From the Util Menu press [1] or press [ENT] key when the System Mode is highlighted. In the System Mode input box, use [� / �] keys to move the selector bar. To change a parameter setting, press the [ENT] key while the parameter field is highlighted. Use the [CLR] key to cancel the selection process. System Mode Parameter Details: Pred (Predicted Equation) - Choices for the predicted equation are:

1) ECCS (European Community for Coal and Steel) 2) Spain 3) Norway 4) Austria 5) Finland 6) ITS (Intermountain Thoracic Society) 7) Knudson 8) Morris 9) Chile 10) Japan

The predicted equation setting defaults to ITS whenever the interpretation selection is set to ITS. Remove the ITS Interpretation setting before changing the predicted equation setting.

Inte (Interpretation)- Choices for the interpretation are:

1) ITS (Intermountain Thoracic Society) 2) Ellis 3) Diagnosis 4) GOLD (Global Obstructive Lung Disease)

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The choice of interpretation will determine the Interpretation display on measurement data and the print result.

When the interpretation is set to ITS, the predicted equation would automatically also be set to ITS. The “GOLD Compliant” message displays only when the Interpretation option is set to GOLD.

DSel (Measurement Data Selection) - Choices for the best measurement

data selection criteria are: 1) ATS (American Thoracic Society) 2) NIOSH (National Institute of Occupational Safety and Hazard)

The best measurement data selection criterion is applicable for all available interpretation except GOLD.

RSel (Reproducibility Selection) - Choices for the set reproducibility

criteria are: 1) ATS (American Thoracic Society) 2) ERS (European Respiratory Society) 3) NIOSH (National Institute of Occupational Safety and Hazard) 4) GOLD (Global Obstructive Lung Disease)

Selecting GOLD for the Interpretation automatically select option GOLD for this setting.

Para (Expiratory Parameter Label) - Choices for the expiratory flow

parameter label are: 1) MEFx (Maximal Expiratory Flow) 2) FEFx (Forced Expiratory Flow)

Unit (Height, Weight & Temperature Unit ) - Choices for the height,

weight and temperature units are: 1) Metric (Centimeters / Kilograms / oC) 2) English (Inches / Pounds / oF)

FRC (Functional Residual Capacity) - Choices for the FRC setting are:

1) On 2) Off

If the FRC were turned off, the Functional Residual Capacity and all other VC parameters dependent on it, i.e., RV, TLC and RV/TLC, would not be computed for.

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Disp (Display Format)- Choices for the measurement parameter

display/print format are: 1) Standard

When standard format is selected, the displayed/printed VC, FVC and MVV parameters shall follow the “Std” settings of Section 5.1 Parameters Definition.

2) Custom

When custom format is selected, the VC, FVC and MVV parameters to be displayed/printed can be selected individually.

Lang (Language)- Choices for language are:

1) English 2) German 3) French 4) Spanish 5) Italian

Accp (Acceptability Selection)- Choices for acceptability criteria are:

1) OFF (inhibit ATS acceptability validation) 2) ON (show ATS acceptability validation

Press [START] to finish the system mode changes, and go to the:

a. Main Menu if there were changes in any field; or b. Util Menu if no change was made to the current system mode.

Or Press [BACK] to cancel system mode changes and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without saving newly entered value(s). Custom Display Sub-function From the System Mode Menu, choose Custom from the Disp field

Typical Custom Display Switch Menu.

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Use [� / �] keys to move the selector bar.

To enter a highlighted field, use the [ENT] key or simply input the field value directly. Inputting a ’1’ or ‘2’ will set the field to “On” or “Off”, respectively, and will cause the cursor to move on to the next field. Inputting a value other than ‘1’ or ‘2’ is equivalent to pressing [ENT] key.

Use the [CLR] key to cancel the selection process. The custom display switches are displayed in multiple pages. Use [� / �] keys to navigate through the different fields in wrap around way. Please see Section 5.1 for all the custom display measurement parameter fields available for viewing/printing: If a field were turned on, its corresponding measurement value would be made available in the VC/FVC/MVV display and in any printed output; otherwise, the corresponding measurement value would not be shown nor printed. If the FRC field is turned off, all the other fields dependent on it, namely, RV, TLC and RV/TLC, would automatically also be turned off and thereupon cannot be turned on until the FRC field itself is turned on.

Press [START] to finish the custom display changes and return to the System Mode Function. Or Press the [BACK] key to cancel any change that has been made to the custom display and go back to the System Mode Function Or Press the [ID], [VC], [FVC], [MVV] or [MENU] key to go to another menu/function without saving newly entered value(s).

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15.2 PATIENT DATA UPLOADING - [2. Transmission] This function is used to transfer (or upload) accumulated patient data from this Spirometer’s data storage to a Personal Computer installed with and operating with the optionally available FS/PC Database Management System or other similar file management systems. Consult our authorized distributor for the FS/PC version suitable for linking with this Spirometer. Or, for information on its serial transfer protocol when attempting to link (for data transfer) this Spirometer to other file management systems.

Options Accredited optional parts may be changed without notice for quality improvement.

Do not use other than the ascribed Serial Communication Cable supplied with the FS/PC product for interconnecting this Spirometer to your FS/PC resident PC. Possible fault or hazard may result.

Electrostatic Discharge

A violent electric shock may result when accumulated electrostatic electricity discharges. Do not touch or cause contact with ESD sensitive device (connectors).

When physically connecting the Serial Communication Cable, do not touch or cause contact with the Spirometer’s Serial Port Connector or any part thereof for ESD protection. From the Util Menu press [3] or press [ENT] key when the Transmission option is highlighted.

CAUTION

CAUTION

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The screen displays the functions available under the Transmission Menu. Select the method by which you want to transmit data:

1) TX - Numeric data only; 2) WTX - Numeric data and waveform; &. 3) Standard – ATS/ERS Task Force data-specification.

To select the desired function, use the [� / �] keys, and to initiate operation, press the [ENT] key or simply key in the item number.

[1] TX - Transmission of numeric data only in Fukuda Sangyo Data Transmission protocol;

[2] WTX – Transmission of measurement and waveform data in Fukuda Sangyo Data Transmission protocol (required for FS/PC uploading); and,

[3] Standard – Transmission of measurement and waveform data as per the ATS/ERS Data Transmission protocol.

Press [BACK] to cancel data transmission and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without saving newly entered value(s). The Transmission function is disabled if there is no record saved in the database. In case of transmission errors, check for the proper interconnection of the Serial Communication Cable and for normal operation of the receiving PC, then repeat the patient data upload procedure. A). TX Sub-Function From the Transmission Menu, press the [1] key or press the [ENT] key when the TX option is highlighted.

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The screen displays the two numbers that give an indication of the data output. The number on the left of the ‘/’ indicates the number of patients whose saved baseline, post or BC record(s), if any, have already been transmitted so far. The number on the right of the ‘/’ indicates the total number of patients whose saved baseline, post or BC record(s), if any, are to be transmitted.

The screen automatically goes back to the Util Menu when all measurement data have been successfully transmitted. Or, The screen automatically goes to the TX Error screen when an error in measurement data transmission occurs. Or, Press [BACK] to cancel measurement data transmission and go back to the Transmission Menu. B). WTX SUB-FUNCTION From the Transmission Menu, press the [2] key or press the [ENT] key when the WTX option is highlighted

The screen displays the two numbers that give an indication of the data output. The number on the left of the ‘/’ indicates the number of patients whose saved baseline, post or BC record(s), if any, have already been transmitted so far. The number on the right of the ‘/’ indicates the total number of patients whose saved baseline, post or BC record(s), if any, are to be transmitted.

The screen automatically goes back to the Util Menu when all measurement

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data have been successfully transmitted. Or, The screen automatically goes to the WTX Error screen when an error in measurement data transmission occurs. Or, Press [BACK] to cancel measurement data transmission and go back to the Transmission Menu. C). STANDARD SUB-FUNCTION From the Transmission Menu, press the [3] key or press the [ENT] key when the Standard option is highlighted Data is transmitted in Comma Separated Value (CSV) format in accordance to the ATS/ERS Task Force recommendations.

Serial Port Setting is Baud Rate = 9600; No parity; 2-Start Bit; &, 1-Stop Bitsy.

The screen displays the two numbers that give an indication of the data output. The number on the left of the ‘/’ indicates the number of patients whose saved baseline, post or BC record(s), if any, have already been transmitted so far. The number on the right of the ‘/’ indicates the total number of patients whose saved baseline, post or BC record(s), if any, are to be transmitted.

The screen automatically goes back to the Util Menu when all measurement data have been successfully transmitted. Or, The screen automatically goes to the Standard Error screen when an error in measurement data transmission occurs. Or, Press [BACK] to cancel measurement data transmission and go back to the Transmission Menu.

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15.3 PRINT SETTINGS - [3. Print Mode] This function is used to set the desired printing mode to a selected printer device. From the Util Menu press [4] or press [ENT] key when the Print Mode is highlighted. Within the print mode field, press [� / �] keys to move the selector bar. To choose a field value, press the [ENT] key while the desired value is highlighted, or simply key in the selection number corresponding to the desired value. Use the [CLR] key to cancel the selection process. Following are the user-selectable print mode fields to be filled in:

Copies – Acceptable range is from 1 to 10 copies. Specifies the number of copies printed per command.

Pred - Choice between On or Off. Specifies whether to include (On) or inhibit (Off) printing of the predicted target lines (for VC) or target waveform (for FVC).

Inter - Choice between On or Off. Specifies whether to include (On) or inhibit (Off) printing of the displayed Interpretation messages.

Race – Choice between On or Off. Specifies whether to show (On) or omit (Off) printing of the patient’s race demographic data.

Device - Choice between Intern and Extern. Selection directs the print outputs to either the internal printing device (Intern) or to the interconnected external printer device (Extern) upon command.

The “Extern” selection under Device requires the further assignment of a printer driver to either the ESC/P or PCL3 options.

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a.[1] ESC/P is used as the printer driver for an EPSON LX 300+ dot matrix printer.

b. [2] PCL3 is used as the printer driver for an HP 2262 ink-jet printer.

c.

Use only the appropriate driver assigned for the interconnected external printer.

In directing your print output to an external printer device, consult our authorized distributor for the accredited external printer models that may be interconnected to this Spirometer. The current print mode setting will be applied every time a patient data print output is initiated through the [PRINT] key command. Press [START] to finish the printer mode changes, and go to the:

a. Main Menu if a there were any changes in the field; or b. Util Menu if no change was made to the current print mode.

Or Press [BACK] to cancel print mode changes and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without saving newly entered value(s).

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15.4 SYSTEM DATE/TIME SETTING - [4. System Date] This function is used to adjust the Spirometer’s local date and time settings. From the Util Menu press [5] or press [ENT] key when the System Date is highlighted. Within the system date field, press [� / �] keys to move the selector bar. To choose a field value, press the [ENT] key while the desired value is highlighted, or simply key in the selection number corresponding to the desired value. Use the [CLR] key to cancel the selection process. Inputting a number not within the acceptable range of the options list is equivalent to pressing the [ENT] key.

Following are the date and time fields to be filled in: Year - Acceptable range is from 0 to 99, translating to the years 2000 through 2099; Month - Acceptable range is from 1 to 12, translating to the months January through February; Day - Acceptable range is from 1 to 28 or 29 if leap year for the month of February; 30 for the months of April, June, September and November; 31 for the months of January, March, May, July, August, October and December; Hour - Acceptable range is from 0 to 23; and, Minute - Acceptable range is from 0 to 59.

The following describe how to enter field values: Use the [� / �] keys to move the cursor. The starting position is always at the rightmost side of the field input box.

Use the [0] - [9] keys to insert a digit before the cursor. Use the [CLR] key to delete the digit before the cursor.

If the value entered is not within the acceptable range, the field value will automatically be set to the minimum acceptable field value if the value entered is less than the minimum, or the maximum acceptable field value if the value entered is greater than the maximum

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Press [START] to finish the system date and time changes, and go to the: a. Main Menu if a new system date or time was entered; or b. Util Menu if no change was made to the current system date and time.

Or Press [BACK] to cancel system date and time changes and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without saving newly entered value(s).

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15.5 DISPLAY CONTRAST SETTING - [5. LCD Contrast] This function is used to set the screen display contrast of this Spirometer. From the Util Menu press [6] or press [ENT] key when the LCD Contrast option is highlighted.

The screen displays the contrast adjustment box, with the current contrast level as indicated by the position of the flashing asterisk.

Press the [►] key to move the asterisk one position to the right, thereby increasing the contrast level by one (1) level. Press the [�] key to move the asterisk one position to the left, thereby decreasing the contrast level by one (1) level. Press the [ENT] key to finish the contrast adjustment and go to the:

a. Main Menu if the LCD contrast level was indeed changed; or b. Util Menu if no actual change was made to the current LCD

contrast level; Or Press the [BACK] key to cancel any adjustment that has been made on the current contrast level and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without saving the new contrast level.

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CHAPTER XVI. DIAGNOSTICS

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Press [CLR] or [STOP] during power on.

The screen displays the functions available under the Diagnostics Menu.

These are:

Display Function 1. Keypad Keypad testing. 2. LCD LCD display testing. 3. Printer Printer testing. 4. RAM Random Access Memory testing. 5. ROM Read Only Memory Testing. 6. Serial Port Serial port testing. 7. Cal Check Calibration Check 8. System Init System initialization.

To select the desired function, use [� / �] keys, and to initiate operation, press the [ENT] key or simply key in the item number [1-8]. Select a diagnostic test. Or Press the [BACK] key to cancel diagnostic testing and proceed to the Main Menu.

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16.1 KEYBOARD TESTING - [1. Keypad] From the Diagnostics Menu press [1] or press [ENT] key when the Keypad device is highlighted. Press all keys in order to determine whether the keys are functioning properly. Every time a key is pressed, the buzzer should sound and the key label should appear on the screen. The absence of a buzzer sound or key name, or an incorrect label display indicates an error. If a press key interval exceeds six (6) seconds, the system would assume that it is at fault in not being able to detect a press key and would therefore report a keypad error. Make sure then to press any two keys within six (6) seconds.

Press each key until a keypad error is detected or until all keys have been pressed in order to view the Keypad Test Result. Or Press the [BACK] key twice to go back to the Diagnostics Menu.

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16.2 LCD TESTING - [2. LCD] From the Diagnostics Menu press [2] or press [ENT] key when the LCD device is highlighted.

First Screen Second Screen The first of two screens to be displayed consists of a 16 x 16 checkerboard.

The second screen to be displayed also consists of a 16 x 16 checkerboard pattern but in reverse fashion. The screens are displayed for three (3) seconds to allow for visual inspection. The screen automatically proceeds to the LCD Test Result when all the LCD pixels have been written to. Or Press any key to abort the LCD testing and go back to the Diagnostics Menu.

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16.3 PRINTER TESTS - [3. Printer] From the Diagnostics Menu press [3] or press [ENT] key when the Printer device is highlighted.

The screen displays a selection of the printer device to test. The screen automatically proceeds to the Printer Test Result when test printing is done.

Typical successfully printed internal printout.

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16.4 RAM TESTS - [4. RAM] From the Diagnostics Menu press [4] or press [ENT] key when the RAM device is highlighted.

The screen displays messages that indicate the RAM testing status: The “Testing RAM…” message is displayed at the start of the RAM Test operation. RAM addresses are displayed while being tested. Ram Test Result The screen displays the message that indicates the RAM test result: The “RAM ok!” message is displayed when the RAM check has been successful. The “RAM failed!” message is displayed when the RAM check has failed. The screen automatically proceeds to the RAM Test Result when all the RAM locations have been written to and verified.

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16.5 ROM TESTS - [5. ROM] From the Diagnostics Menu press [5] or press [ENT] key when the ROM device is highlighted.

The screen displays a message indicating that the ROM is currently being tested.

ROM Test Result The screen displays a message that indicates the ROM test result. The “ROM ok!” message is displayed when the ROM check has been successful. The “ROM failed!” message is displayed when the ROM check has failed. The screen automatically proceeds to the ROM Test Result when the ROM checksum has been verified.

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16.6 SERIAL PORT TESTS - [6. Serial Port] From the Diagnostics Menu press [6] or press [ENT] key when the Serial Port device is highlighted. The screen displays the external loop testing status. Send [ ] - Displays within the brackets the next character in the ASCII character set (0-254) that is to be transmitted over the serial port.

Recv [ ] - Displays the last character that has been received over the serial port.

Note that in order for the serial port test to be conducted successfully, a loop back cable should already be connected to the serial port upon entry into this function.

Serial Port Test Result The screen displays a message that indicates the serial port test result. The “Transmit/receive ok!” message is displayed when data has been transmitted and received over the serial port. The “Transmit/receive failed!” message is displayed when data has not been transmitted and received over the serial port. The screen automatically proceeds to the Serial Port Test Result when external loop back testing has been completed or when an error is encountered.

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16.7 CALIBRATION CHECK - [7. Cal Check] Calibration Check is used to periodically maintain your Spirometer’s operational integrity and measurement accuracy. In this procedure, a series of progressing air flow using a constant volume of air from a Syringe (1L, 2L or 3L standard) is driven in and drawn out through the Spirometer’s Flow Sensing circuitry. Perform this validation routine on the following instances: � Before use for the first time. � At routine intervals.

Proper validation practice recommends daily calibrations to assure that the Spirometer is calibrated and working properly.

� In connecting the calibration syringe to the flow sensor, make sure that

the adapter, syringe and the flow sensor are aligned to prevent leakage. From the Diagnostics Menu press [7] or press [ENT] key when the Cal Check option is highlighted.

The Calibration Check set-up menu is displayed. Then enter the Calibration Syringe standard to use. Selection can either be keyed-in directly, or press the [� / �] keys to select the listed volume.

The user is then instructed to check on the syringe set-up with follow-up instructions.

Press [START] to proceed with the Calibration Check; Or, Press [BACK] to cancel Calibration Check and go back to the Util Menu. Or Press [ID], [VC], [FVC], [MVV] or [MENU] to go to another menu/function without displaying the calibration validation result.

112

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The Calibration Check function is disabled if the current printing device is set to external printer.

CALIBRATION MEASUREMENT From within the Calibration function, press [START] to commence. When set, the calibration screen shows a Flow-Volume scale where flow data from your syringe standard will be plotted. There are dotted lines that define the target expiratory and inspiratory flow lines. Note that the target flow lines changes with each measurement cycle. Calibration consists of three (3) measurement cycles. When an expiration - inspiration measurement cycle has been completed successfully, the current graph is cleared in order to proceed to the next measurement cycle. Otherwise, calibration measurement is aborted and an error message is displayed on the screen.

The two numbers to the left of the function name give an indication of the calibration measurement progress. The left number to the ‘/’ indicates the current measurement number while right number indicates the total number of measurements to be made.

When the buzzer sounds to signal the start of a calibration measurement

113

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cycle, simulate an exhalation using the syringe. During this time a waveform illustrating the expiration process will be graphed on the FV scale. When the buzzer sounds again, shift to simulating an inhalation with the syringe. Again, a waveform now illustrating the inspiration process will be seen on the screen.

The calibration syringe shaft should be fully extended when pulled and fully depressed when pushed to ensure correct and constant air volume movement.

The screen automatically goes to the Calibration Check result screen if calibration measurement was correctly performed.

Typical successful Calibration Check result. When a “Possible range check” message is displayed, the acquired readings are already exhibiting a borderline performance.

Typical Possible Range Check display. Hardware failure of the Calibration Check will display the following screen.

Typical Hardware Fault display result.

114

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Correlate the hardware fault using the following table for appropriate corrective measure.

Display Message Description Incorrect measurement procedure.

Timeout occurred during pumping.

Possible Range Check. Measured expiratory volume is over ± 3.0% of standard volume; or, measured inspiratory volume is over ± 10.0% of standard volume

Check for Procedure or Hardware Fault..

Measured expiratory volume is over ± 5% of standard volume; or, measured inspiratory volume is over ± 15% of standard volume.

In the case, where the ‘Possible Range Check” displays before the display results are shown, check the Performance Index [Perf] field row of the display results. If an asterisk is shown, replace the SpiretteTM Tube with a new one and perform calibration check until asterisk clears.

If calibration should be unsuccessful despite a number of attempts, consult your authorized local service personnel. The calibration results may be printed to the internal Printer by depressing the [PRINT] key. Or Press [BACK] to cancel calibration measurement and go back to the Calibration function.

115

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16.8 SYSTEM INITIALIZE - [8. System Init] From the Diagnostics Menu press [8] or press [ENT] key when the System Init Function is highlighted. This is a controlled function and should only be used by an authorized service personnel for servicing purposes. If however an unauthorized access is initiated, the initialization action will require entering a password.

Pressing the [ENT] key, the password screen will display. If the user chooses not to proceed, your current system settings will be retained. Initializing however will result into loss of your current settings and patient records. Enter the password to proceed with system initialization and go back to the Diagnostics Menu. Or Press the [BACK] key to cancel system initialization and go back to the Diagnostics Menu.

116

CHAPTER XVII. CLEANING AND STERILIZING

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Before using the Spirometer for a patient, ensure full hygiene and contamination control through the following:

• Maintain cleanliness of the Spirometer and its attached accessories at all times.

• Immediately replace contaminated or used SpiretteTM Tubes and other items that directly contact patients.

All parts of this Spirometer that may be contaminated by the patient can be physically cleansed and disinfected. However, before subjecting the Spirometer or its accessories to this procedures:

• Always unplug your Spirometer from its electrical outlet. • Do not use any scrubbing agents or solvents (alcohol or acetone, for

example) to clean the Spirometer or its accessories. • In general, any cleaning procedure that heats the materials above 45oC

may affect the life of the material. CLEANING THE EXTERNALS

1) Clean external surfaces with a damp cloth or sponge. However hard scrubbing should not be done.

2) Make sure that no drip flows along the external surface during cleaning.

3) Ensure that the Spirometer or any part thereof is completely dry after cleaning.

CLEANING THE NOSE CLIP Clean and disinfect the Nose Clip by using alcohol or a detergent solution to wipe clean.

117

CHAPTER XVIII. SAFEKEEPING

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For prolonged storage of the Spirometer, the following prior action should be conducted:

1) Ensure that power is switched off and the power cord unplugged from the wall socket.

2) If the Spirometer is soiled, wipe clean using a mild detergent in a damp cloth. Then wipe dry cloth until no detergent remains.

3) Do not locate in a place that is exposed to direct sunlight, in contact with water or is subjected to excessive vibration.

4) For best storage protection, store in its original packaging and seal.

5) Do not store in places where significant temperature, humidity or pressure change occurs or where ambient dusts, salts or ions are found.

6) Check all the accessories and store complete with its Main Unit. If any part of your Spirometer should be dropped, it is imperative that authorized service personnel perform a thorough check. Further use of the Spirometer should only be done after a satisfactory inspection.

118

CHAPTER XIX. MAINTENANCE AND INSPECTION

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This Spirometer requires routine inspection before use and a regular periodic inspection in order to maintain its proper functionality. Routine inspection and regular inspection should be performed in the following ways:

1) Routine inspection (inspection before use) -

Inspection of the physical unit, accessories and functional performance.

2) Regular inspection (semi-annual or annual inspection) - Inspection of the physical function and validation of performance.

3) You may reproduce copies of the sample ”Routine Inspection Record.” and Regular Inspection Record” for your use.

Should you be unable to conduct the regular maintenance and inspection routines, please submit the Spirometer to our authorized service personnel for preventive servicing to ensure safe and proper operation.

For disposal and scrapping of your used Spirometer or any part thereof, follow your local statutes.

119

“Sample Copy”

Routine Inspection Record Control No.:

Item Inspection Criteria Result Remarks

(Need repair) Main Unit - Built-in Printer -Thermal Paper installed properly.

- Printer Cover closed snugly. Good/ NG

- Flow Sensor Connector - Ext Printer Connector - Serial Port Connector

- Clear of any foreign matter - No signs of corrosion.

Good/ NG

- Serial Number - Markings

- Identification marks & symbols legible.

Good/ NG

- Flow Sensor - Handle Clean. - Spirette Tube clean. - Spirette Tube locked in position. - Data Cable connected.

Good/ NG

Accessories - Power Cord- - No stripped insulation, extreme bend and other defects.

Good/ NG

- AC Mains - When powered on, power-on indicator lights.

Good/ NG

Performance - LCD - Main screen displays clearly on LCD.

Good/ NG

- Printing - Prints with no garbled characters or missing dots.

Good/ NG

- Operational Keys - Buzzer

- Pressing operation keys displays corresponding screens.

Good/ NG

-Calibration Check -- Successfully conducted with variation not > 10%.

Good/ NG

Good/ NG

Good/ NG

Overall Judgment Good/ NG

Type Easy on-Desk Program Version

Serial No. Date Purchased

Location

Inspection Date: Inspected By:

(Signature over Printed Name)

Approved By:

(Signature over Printed Name)

120

“Sample Copy” Regular Inspection Record

Control No.:

Item Inspection Criteria Result Remarks

(Need repair)

Historical Performance

- Routine inspection. - No items judged as “NG” during past routine inspections.

Good/ NG

Accessories - Flow Sensor - Spirette Tube can be smoothly removed and restored.

Good/ NG

Performance - Operational Keys - Buzzer

- Using the Diagnostic Menu (Keypad Test), pressing each operation keys displays corresponding label with an audible buzzer sound.

Good/ NG

- Calibration Check - No abnormal variation in “Insp” and “Exp” correction factors.

Good/ NG

- Measurement - Using Patient ID# 0000000000, acquire FVC measurements using a Calibration Syringe standard should have a tolerance reading of no more than ± 3%.

Good/ NG

- Database management - Measurement data can be stored, loaded and deleted.

Good/ NG

Overall Judgment Good/ NG

Remarks Type Easy on-Desk Program Version

Serial No. Date Purchased

Location

Date of inspection

Inspected By:

(Signature over Printed Name)

Approved By:

(Signature over Printed Name)

121

CHAPTER XX. AFTER SALES SERVICE

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WARRANTY Our products are made using production methods and resources qualified for quality. We therefore provide a warranty for our products against defects of any nature provided the user has maintained safe and proper usage of the product in accordance to this Users Manual. Should the above instance be required during the warranty period of one (01) year from date of purchase, we shall make repairs free of charge in accordance with the provisions provided for in the warranty certificate.

Warranty Violation

Interconnection to uncertified external equipment or use of uncertified replacement components or unauthorized software modifications and patches may void this product’s warranty.

Before submitting your Spirometer for repair, take time to use the Troubleshooting section of this manual to confirm your perceived fault of the instrument. In most cases, these may resolve the problem thus minimizing downtime of your Spirometer. After the expiration of the warranty period, we will make repairs as requested at your expense, provided that your Spirometer as determined by us is still in a repairable state. Please contact our authorized representative in your area for this repair facility. After the discontinuance of production for this model (which is announced through our authorized representatives), we are committed to make repair parts available for another five (5) years as a regulatory repair period. After expiration of the regulatory repair period, we shall still endeavor to make extended repair activities provided the technology and availability of replacement parts will still be obtainable. Please consult our authorized representatives for details regarding this. PRODUCT LIFE This Spirometer by proper usage should relatively have a functional product life of five (5) years.

CAUTION

122

APPENDIX 1. Predicted Equations a. ITS (Intermountain Thoracic Society)

Parameter Sex Age Predicted Equation 95% CI Reference

VC (l) (all) 7+ Pred. FVC

FVC (l) M 7-18 W 3.58×10-4×H3.18÷1000 13 1 (Hsu)

M 7-18 B 1.07×10-3×H2.93÷1000 17 1 (Hsu)

M 19+ 0.0600×H−0.0214×A−4.650 1.12 1 (Crapo)

F 7-18 W 2.57×10-3×H2.78÷1000 14 1 (Hsu)

F 7-18 B 8.34×10-4×H2.98÷1000 15 1 (Hsu)

F 19+ 0.0491×H−0.0216×A−3.590 0.68 1 (Crapo)

FEV.5 (l) M 19+ 0.0327×H−0.0152×A−1.914 0.71 1 (Crapo)

F 19+ 0.0238×H−0.0185×A−0.809 0.51 1 (Crapo)

FEV1 (l) M 7-18 W 7.74×10-4×H3.00÷1000 13 1 (Hsu)

M 7-18 B 1.03×10-3×H2.92÷1000 17 1 (Hsu)

M 19+ 0.0414×H−0.0244×A−2.190 0.84 1 (Crapo)

F 7-18 W 3.79×10-3×H2.68÷1000 14 1 (Hsu)

F 7-18 B 1.14×10-3×H2.89÷1000 15 1 (Hsu)

F 19+ 0.0342×H−0.0255×A−1.578 0.56 1 (Crapo)

FEV3 (l) M 19+ 0.0535×H−0.0271×A−3.512 1.02 1 (Crapo)

F 19+ 0.0442×H−0.0257×A−2.745 0.62 1 (Crapo)

FEV1%G (%) M 19+ −0.1300×H−0.152×A+110.49 8.3 1 (Crapo)

F 19+ −0.2020×H−0.252×A+126.58 9.1 1 (Crapo)

FEV3%G (%) M 19+ −−−−0.0627×H−−−−0.145×A+112.09 4.6 1 (Crapo)

F 19+ −−−−0.0937×H−−−−0.163×A+118.16 5.4 1 (Crapo)

MMEF (l/s) M 7-18 W 7.98×10-4×H2.46÷÷÷÷60 26 1 (Hsu)

M 7-18 B 3.61×10-4×H2.60÷÷÷÷60 36 1 (Hsu)

M 19+ 0.0204×H−−−−0.0380×A+2.133 1.67 1 (Crapo)

F 7-18 W 3.79X10-3×H2.16÷÷÷÷60 28 1 (Hsu)

F 7-18 B 1.45X10-3×H2.34÷÷÷÷60 30 1 (Hsu)

F 19+ 0.0154×H−−−−0.0460×A+2.683 1.36 1 (Crapo)

PEF (l/s) M 7-18 W 3.35×10-4×H2.79÷÷÷÷60 18 1 (Hsu)

M 7-18 B 1.74×10-4×H2.92÷÷÷÷60 22 1 (Hsu)

M 19-24 0.078×H+0.166×A−−−−8.060 K1

M 25+ 0.094×H−−−−0.035×A−−−−5.993 K1

F 7-18 W 2.58×10-3×H2.37÷÷÷÷60 18 1 (Hsu)

F 7-18 B 5.51×10-4×H2.68÷÷÷÷60 20 1 (Hsu)

F 19 0.049×H+0.157×A−−−−3.916 K1

F 20+ 0.049×H−−−−0.025×A−−−−0.735 K1

FEF25% (l/s) M 7-24 0.070×H+0.147×A−−−−7.054 K1

M 25+ 0.088×H−−−−0.035×A−−−−5.618 K1

F 7-19 0.044×H+0.144×A−−−−3.365 K1

F 20+ 0.043×H−−−−0.025×A−−−−0.132 K1

FEF50% (l/s) M 7-11 0.0378×H−−−−2.5454 94.789 K2

M 12-24 0.0543×H+0.1150×A−−−−6.3851 96.052 K2

M 25+ 0.0684×H−−−−0.0366×A−−−−5.5409 92.734 K2

F 7-10 0.1846×A+0.7362 93.286 K2

F 11-19 0.0288×H+0.1111×A−−−−2.3040 95.109 K2

F 20-69 0.0321×H−−−−0.0240×A−−−−0.4371 95.065 K2

F 70+ 0.0118×H−−−−0.0755×A+6.2402 95.144 K2

Continued…

123

Parameter Sex Age Predicted Equation 95% CI Reference

FEF75% (l/s) M 7-11 0.0171×H−−−−1.0149 92.505 K2

M 12−−−−24 0.0397×H−−−−0.0057×A−−−−4.2421 94.591 K2

M 25+ 0.0310×H−−−−0.0230×A−−−−2.4827 90.674 K2

F 7-10 0.0109×H−−−−0.1657 90.705 K2

F 11-19 0.0243×H+0.2923×A−−−−4.401−−−−0.0075×A2 94.465 K2

F 20-69 0.0174×H−−−−0.0254×A−−−−0.1822 91.473 K2

F 70+ −−−−0.0172×A+1.8894 92.742 K2

MVV (l/min) M 7-18 Pred. FEV1×40 2

M 19+ 1.34×H−−−−1.26×A−−−−21.4 ±56.8 1 (Kory)

F 7-18 Pred. FEV1×40 2

F 19+ 0.807×H−−−−0.57×A−−−−5.50 ±21.0 1 (Lindall)

FRC (l) M 15-91 0.0472×H+0.0090×A−−−−5.290 ±1.46 1 (Crapo)

F 17-84 0.0360×H+0.0031×A−−−−3.182 ±1.06 1 (Crapo)

RV (l) M 15-91 0.0216×H+0.0207×A−−−−2.840 ±0.76 1 (Crapo)

F 17-84 0.0197×H+0.0201×A−−−−2.421 ±0.78 1 (Crapo)

TLC (l) M 15-91 0.0795×H+0.0032×A−−−−7.333 ±1.61 1 (Crapo)

F 17-84 0.0590×H−−−−4.537 ±1.08 1 (Crapo)

RV/TLC (%) M 15-91 0.3090×A+14.060 ±8.80 1 (Crapo)

F 17-84 0.4160×A+14.350 ±11.0 1 (Crapo)

BSA (m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

*When others is selected, the predicted equation is used same as white.

Symbol Definition Unit Range

A Age years M 7-91

F 7-84

H Height cm M 7-18 111-190cm

M 19+ 157-194cm

F 7-18 111-180cm

F 19+ 146-178cm

W Weight kg

Reference: 1(author)= : Hsu, Crapo, Lindall, and Kory. CLINICAL PULMONARY FUNCTION

TESTING 2nd Edition 1984, Intermountain Thoracic Society. K1= : Knudson, R. J., et al. The Maximal Expiratory Flow - Volume Curve

Normal Standards, Variability, and Effects of Age. AM REV RESPIR DIS 1976; 113:587-600.

K2= : Knudson, R. J., et al. Changes in the Normal Maximal Expiratory Flow-

Volume Curve with Growth and Aging. AM REV RESPIR DIS 1983; 127:725−−−−734.

2= : Anonymous, Not Published.

124

b. KNUDSON (83)

Parameter Sex Age Predicted Equation 95% CI Reference

VC(l) (all

) 6+ Pred. FVC

FVC (l) M 6-11 0.0409×H−3.3756 96.413 K2

M 12-24 0.0590×H+0.0739×A−6.8865 98.100 K2

M 25+ 0.0844×H−0.0298×A−8.7818 94.653 K2

F 6-10 0.0430×H−3.7486 95.539 K2

F 11-19 0.0416×H+0.0699×A−4.4470 96.885 K2

F 20-69 0.0444×H−0.0169×A−3.1947 96.493 K2

F 70+ 0.0313×H−0.0296×A−0.1889 96.614 K2

FEV.5 (l) M 6-24 0.030×H+0.043×A−3.054 K1

M 25+ 0.037×H−0.017×A−2.746 K1

F 6-19 0.019×H+0.061×A−1.738 K1

F 20+ 0.019×H−0.014×A−0.406 K1

FEV1 (l) M 6-11 0.0348×H−2.8142 96.997 K2

M 12-24 0.0519×H+0.0636×A−6.1181 97.970 K2

M 25+ 0.0665×H−0.0292×A−6.5147 95.551 K2

F 6-10 0.0336×H−2.7578 96.300 K2

F 11-19 0.0351×H+0.0694×A−3.7622 97.073 K2

F 20-69 0.0332×H−0.0190×A−1.8210 96.944 K2

F 70+ 0.0143×H−0.0397×A+2.6539 97.048 K2

FEV3 (l) M 6-24 0.052×H+0.066×A−5.531 K1

M 25+ 0.063×H−0.031×A−5.245 K1

F 6-19 0.033×H+0.086×A−3.417 K1

F 20+ 0.035×H−0.023×A−1.633 K1

FEV1%G (%) M 6-24 −0.0813×H+100.4389 99.035 K2

M 25+ −0.1050×A+86.6862 98.348 K2

F 6-19 −0.1909×H+0.6655×A+109.9739 98.687 K2

F 20+ −0.1852×H−0.1896×A+121.6777 98.742 K2

MMEF (l/s) M 6-11 0.0338×H−2.3197 94.410 K2

M 12-24 0.0539×H+0.0749×A−6.1990 95.975 K2

M 25+ 0.0579×H−0.0363×A−4.5175 92.814 K2

F 6-10 0.0220×H−0.8119 92.630 K2

F 11-19 0.0279×H+0.1275×A−2.8007 95.015 K2

F 20-69 0.0300×H−0.0309×A−0.4057 94.559 K2

F 70+ −0.0615×A+6.3706 93.714 K2

PEF (l/s) M 6-24 0.078×H+0.166×A−8.060 K1

M 25+ 0.094×H−0.035×A−5.993 K1

F 6-19 0.049×H+0.157×A−3.916 K1

F 20+ 0.049×H−0.025×A−0.735 K1

FEF25% (l/s) M 6−24 0.070×H+0.147×A-7.054 K1

M 25+ 0.088×H-0.035×A-5.618 K1

F 6−19 0.044×H+0.144×A-3.365 K1

F 20+ 0.043×H-0.025×A-0.132 K1

Continued…

125

Parameter Sex Age Predicted Equation 95% CI Reference

FEF50% (l/s) M 6−11 0.0378×H−2.5454 94.789 K2

M 12−24 0.0543×H+0.1150×A−6.3851 96.052 K2

M 25+ 0.0684×H−0.0366×A−5.5409 92.734 K2

F 6−10 0.1846×A+0.7362 93.286 K2

F 11−19 0.0288×H+0.1111×A−2.3040 95.109 K2

F 20−69 0.0321×H−0.0240×A−0.4371 95.065 K2

F 70+ 0.0118×H−0.0755×A+6.2402 95.144 K2

FEF75% (l/s) M 6−11 0.0171×H−1.0149 92.505 K2

M 12−24 0.0397×H−0.0057×A−4.2421 94.591 K2

M 25+ 0.0310×H−0.0230×A−2.4827 90.674 K2

F 6−10 0.0109×H−0.1657 90.705 K2

F 11−19 0.0243×H+0.2923×A−4.401−0.0075×A2 94.465 K2

F 20−69 0.0174×H−0.0254×A−0.1822 91.473 K2

F 70+ −0.0172×A+1.8894 92.742 K2

MVV (l/min) M 6−19 Pred. FEV1×40 Anon

M 20+ 1.15×H−1.27×A+14 Comp

F 6−19 Pred. FEV1×40 Anon

F 20+ 0.55×H−0.72×A+50 Comp

FRC (l) M 15−91 0.0472×H+0.0090×A−5.290 ±1.46 Crapo

F 17−84 0.0360×H+0.0031×A−3.182 ±1.06 Crapo

RV (l) M 15−91 0.0216×H+0.0207×A−2.840 ±0.76 Crapo

F 17−84 0.0197×H+0.0201×A−2.421 ±0.78 Crapo

TLC (l) M 15−91 0.0795×H+0.0032×A−7.333 ±1.61 Crapo

F 17−84 0.0590×H−4.537 ±1.08 Crapo

RV/TLC (%) M 15−91 0.3090×A+14.060 ±8.80 Crapo

F 17−84 0.4160×A+14.350 ±11.0 Crapo

BSA (m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

Symbol Definition Unit

A Age years

H Height cm

Reference: K1= : Knudson, R. J., et al. The Maximal Expiratory Flow - Volume Curve

Normal Standards, Variability, and Effects of Age. AM REV RESPIR DIS 1976; 113:587-600.

K2= : Knudson, R. J., et al. Changes in the Normal Maximal Expiratory Flow-

Volume Curve with Growth and Aging. AM REV RESPIR DIS 1983; 127:725−−−−734.

Comp= : Composite of Kory, Cherniack, and Armstrong studies. Crapo= : R. O. Crapo, A. H. Morris. Lung Volumes in Healthy Nonsmoking

Adults. BULL EUROP PHYSIOPATHOL RESPIR 1982; 18: 419−−−−425 Anon= : Anonymous, Not Published.

126

c. MORRIS / POLGAR

Parameter Sex Age Predicted Equation 95% CI Reference

VC (l) (all ) 5+ Pred. FVC

FVC (l) M 5-17 4.4×10-3×H2.67÷1000 P

M 18+ 0.058×H−0.025×A−4.241 M

F 5-17 3.3×10-3×H2.72÷1000 P

F 18+ 0.045×H−0.024×A−2.852 M

FEV0.5 (l) M 6-24 0.030×H+0.043×A−3.054 K1

M 25+ 0.037×H−0.017×A−2.746 K1

F 6-19 0.019×H+0.061×A−1.738 K1

F 20+ 0.019×H−0.014×A−0.406 K1

FEV1.0 (l) M 5-17 2.1×10-3×H2.80÷1000 P

M 18+ 0.036×H−0.032×A−1.260 M

F 5-17 2.1×10-3×H2.80÷1000 P

F 18+ 0.035×H−0.025×A−1.932 M

FEV1%G (%) M 18+ −0.123×H−0.2422×A+107.12 M

F 18+ −0.027×H−0.1815×A+88.70 M

MEFR (l/s)1 M 18+ 0.043×H−0.047×A+2.010 M

F 18+ 0.057×H−0.036×A−2.532 M

MMEF (l/s) M 5-17 (2.621×H−207.70)÷60 P

M 18+ 0.019×H−0.045×A+2.513 M

F 5-17 (2.621×H−207.70)÷60 P

F 18+ 0.024×H−0.030×A+0.551 M

PEF (l/s) M 5-17 (5.2428×H−425.5714)÷60 P

F 5-17 (5.2428×H−425.5714)÷60 P

FEF25% (l/s) M 6−24 0.070×H+0.147×A-7.054 K1

M 25+ 0.088×H-0.035×A-5.618 K1

F 6−19 0.044×H+0.144×A-3.365 K1

F 20+ 0.043×H-0.025×A-0.132 K1

FEF50% (l/s) M 6−11 0.0378×H−2.5454 94.789 K2

M 12−24 0.0543×H+0.1150×A−6.3851 96.052 K2

M 25+ 0.0684×H−0.0366×A−5.5409 92.734 K2

F 6−10 0.1846×A+0.7362 93.286 K2

F 11−19 0.0288×H+0.1111×A−2.3040 95.109 K2

F 20−69 0.0321×H−0.0240×A−0.4371 95.065 K2

F 70+ 0.0118×H−0.0755×A+6.2402 95.144 K2

FEF75% (l/s) M 6−11 0.0171×H−1.0149 92.505 K2

M 12−24 0.0397×H−0.0057×A−4.2421 94.591 K2

M 25+ 0.0310×H−0.0230×A−2.4827 90.674 K2

F 6−10 0.0109×H−0.1657 90.705 K2

F 11−19 0.0243×H+0.2923×A−4.401−0.0075×A2 94.465 K2

F 20−69 0.0174×H−0.0254×A−0.1822 91.473 K2

F 70+ −0.0172×A+1.8894 92.742 K2

MVV (l/min) M 7-17 1.276×H−99.5 P

M 18+ 1.34×H−1.26×A−21.4 Kory

F 7-17 1.276×H−99.5 P

F 18+ 0.807×H−0.57×A−5.50 Lindall

1 This is not measurement parameter; predicted value is not displayed and printed.

127

Continued…

Parameter Sex Age Predicted Equation 95% CI Reference

FRC (l) M 7-17 0.75×10-3×H2.92÷1000 P

M 18−91 0.0472×H+0.0090×A−5.290 ±1.46 Crapo

F 7-17 1.78×10-3×H2.74÷1000 P

F 18-84 0.0360×H+0.0031×A−3.182 ±1.06 Crapo

RV (l) M 7-17 4.41×10-3×H2.41÷1000 P

M 18−91 0.0216×H+0.0207×A−2.840 ±0.76 Crapo

F 7-17 4.41×10-3×H2.41÷1000 P

F 18-84 0.0197×H+0.0201×A−2.421 ±0.78 Crapo

TLC (l) M 7-17 5.6×10-3×H2.67÷1000 P

M 18−91 0.0795×H+0.0032×A−7.333 ±1.61 Crapo

F 7-17 4.0×10-3×H2.73÷1000 P

F 18-84 0.0590×H−4.537 ±1.08 Crapo

RV/TLC (%) M 15−91 0.3090×A+14.060 ±8.80 Crapo

F 17−84 0.4160×A+14.350 ±11.0 Crapo

BSA (m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

Symbol Definition Unit

A Age years

H Height cm

W Weight kg

Reference: P= : George Polgar, M.D. and Varuni Promadhat, M.D. Pulmonary Function

Testing In Children: Techniques And Standard, 1971. M= : James F. Morris, Arthur Koski, and Lavon C.Johnson. Spirometric

Standards for Healthy Nonsmoking Adults. AM REV RESPIR DIS 1971; 103:57−−−−67.

K1= : Knudson, R. J., et al. The Maximal Expiratory Flow - Volume Curve. Normal Standards, Variability, and Effects of Age. AM REV RESPIR DIS 1976; 113:587-600.

K2= : Knudson, R. J., et al. Changes in the Normal Maximal Expiratory Flow-

Volume Curve with Growth and Aging. AM REV RESPIR DIS 1983; 127:725−−−−734.

Crapo= : R. O. Crapo, and A. H. Morris. Lung Volumes in Healthy Nonsmoking Adults. BULL EUROP PHYSIOPATHOL RESPIR 1982; 18: 419−−−−425

128

d. ECCS (European Community for Coal and Steel 82, ERS-corrected in ‘93)

Parameter Sex Age Predicted Equation RSD Remarks

VC (l) M 7-17 Pred. FVC 0.393

M 25-70 6.10×H−0.028×A−4.65 0.56

F 7-17 Pred. FVC 0.263

F 25-70 4.66×H−0.026×A−3.28 0.42

FVC (l) M 7-17 7.9942−0.12509×H+0.000605×H2 0.393

M 25-70 5.76×H−0.026×A−4.34 0.61

F 7-17 0.169−0.01217×H+0.000189×H2 0.263

F 25-70 4.43×H−0.026×A−2.89 0.43

FEV1 (l) M 7-17 6.6314×H-0.10261×H+0.000499×H2 0.523

M 25-70 4.30×H−0.029×A−2.49 0.51

F 7-17 0.0364×H−3.0378 0.42

F 25-70 3.95×H−0.025×A−2.60 0.38

FEV1%T (%) M 7-17 84.5 (84.47) 4.55

M 25-70 −0.18×A+87.21 7.17

F 7-17 84.5 (84.47) 4.55

F 25-70 −0.19×A+89.10 6.51

FEV1%G (%) (all) 7+ Pred FEV1%T (%)

MMEF (l/s) M 25-70 1.94×H−0.043×A+2.70 1.04

F 25-70 1.25×H−0.034×A+2.92 0.85

PEF (l/s) M 7-17 −6.9865+0.0806×H

M 25-70 6.14×H−0.043×A+0.15 1.21 *1

F 7-17 0.06594×H−5.3794

F 25-70 5.50×H−0.030×A−1.11 0.90 *1

MEF75% (l/s) M 7-17 −6.822+0.07811×H

M 25-70 5.46×H−0.029×A−0.47 1.71

F 7-17 0.06367×H−5.1934

F 25-70 3.22×H−0.025×A+1.60 1.35

MEF50% (l/s) M 7-17 −4.5848+0.0543×H

M 25-70 3.79×H−0.031×A−0.35 1.32

F 7-17 0.04477×H−3.3655

F 25-70 2.45×H−0.025×A+1.16 1.10

MEF25% (l/s) M 7-17 −2.3069+0.02817×H

M 25-70 2.61×H−0.026×A−1.34 0.78

F 7-17 0.02483×H−1.8576

F 25-70 1.05×H−0.025×A+1.11 0.69

MVV (l/s) M 18+ 1.19×H−0.816×A−37.95

F 18+ 0.842×H−0.685×A−4.87

FRC (l) M 7-17 9.372−0.1415×H+0.000602×H2 0.35

M 25-70 2.34×H+0.009×A−1.09 0.6

F 7-17 0.02556×H−2.1778 0.26

F 25-70 2.24×H+0.001×A−1.00 0.50

RV (l) M 7-17 −1.052+0.012×H

M 25-70 1.31×H+0.022×A−1.23 0.41

F 7-17 −0.805+0.0109×H

F 25-70 1.81×H+0.016×A−2.00 0.35

Continued…

129

Parameter Sex Age Predicted Equation RSD Remarks

TLC (l) M 7-17 15.1397-0.22713xH+0.001002×H2

M 25-70 7.99×H−7.08 0.70

F 7-17 1.7592-0.03394×H+00003xH2

F 25-70 6.60×H−5.79 0.60

RV/TLC (%) M 7-17 34.7−0.0647×H 3.91

M 25-70 0.39×A+13.96 5.46

F 7-17 34.7−0.0647×H 3.91

F 25-70 0.34×A+18.96 5.83

FRC/TLC (%) M 7-17 38.73+0.0615×H 4.0 *2

M 25+ 0.21×A+43.8 6.74 *2

F 7-17 38.73+0.0615×H 4.0 *2

F 25+ 0.16×A+45.1 5.93 *2

RSD: residual standard deviation.

Predicted values: Between 18 and 25 year substitute 25 year in the equations.

*1: Mixture from (mini-)Wright peak flowmeter and pneumotachometer: more work is needed.

*2: This is not measurement parameter; predicted value is not displayed and not printed.

Symbol Definition Unit

A Age years

H Height m

H (MVV) Height cm

W Weight kg

Reference Adult: Standard Lung Function Testing Official Statement of the European Respiratory Society European Community for Steel and Coal Luxembourg, 1993 Eur Respir J, 1993, 6, Suppl. 16 Reference Pediatric: Compilation of reference values for lung function measurements in children Ph.h.Quanjer, J.Stocks, G.Polgar, M.Wise, J.Karlberg, G.Borsboom Eur Respir J 1989, 2, Suppl. 4, 184s-261s

130

e. SPAIN (Multicèntrico di Barcelona)

Parameter Sex Age Predicted Equation SD SEE Remarks

VC (l) M 3-19 Pred. FVC

(SVC) M 20-90 0.06103×H−0.028×A−4.654 0.56 ECCS 1

F 3-19 Pred. FVC

F 20-90 0.04664×H−0.024×A−3.284 0.42 ECCS 1

FVC (l) M 3-19 0.028×H+0.03451×W+0.05728×A−3.21 0.443

M 20-90 0.0678×H−0.0147×A−6.0548 0.768 0.53 1

F 3-19 0.03049×H+0.0222×W+0.0355×A−3.04 0.313

F 20-90 0.0454×H−0.0211×A−2.8253 0.608 0.403 1

FEV1 (l) M 3-19 0.02483×H+0.02266×W+0.07148×A−2.91 0.378

M 20-90 0.0499×H−0.0211×A−3.837 0.665 0.44 1

F 3-19 0.02866×H+0.01713×W+0.02955×A−2.87 0.263

F 20-90 0.0317×H−0.025×A−1.2324 0.533 0.307 1

FEV3 (l) M 3-19 (−0.022×A+0.0469×H−2.815)×0.93

M 20-90 (0.0678×H−0.0147×A−6.0548)×0.93

F 3-19 (−0.022×A+0.0366×H−1.924)×0.93

F 20-90 (0.0454×H−0.0211×A−2.8253)×0.93

FEV1%T (%) M 20-90 −0.16×A+85.62

F 20-90 −0.24×A+91.02

FEV1%G (%) M 20-90 −0.1902×A+85.58 5.85 5.36 1

F 20-90 −0.224×A−0.1126×W+94.88 6.29 5.31 1

MMEF (l/s) M 3-19 0.038×H+0.14×A−4.33 0.796

M 20-90 0.0392×H−0.043×A−1.1574 1.21 1 7

F 3-19 0.046×H+0.051×A−4.3 0.651

F 20-90 0.023×H−0.0456×A+1.1055 0.96 0.68 7

PEF (l/s) M 3-19 0.075×H+0.275×A−9.08 1.073

M 20-90 0.0945×H−0.0209×A−5.7732 1.67 1.47 7

F 3-19 0.73×H+0.134×A−7.57 0.831

F 20-90 0.0448×H−0.0304×A+0.3496 1.18 1.04 7

FEF50% (l/s) M 3-19 0.017×H+0.157×A+0.029×W−2.17 0.811

M 20-90 0.0517×H−0.0397×A−2.4 1.47 1.3 1

F 3-19 0.046×H+0.067×A−4.17 0.669

F 20-90 0.0242×H−0.0418×A+1.6151 1.11 0.925 1

FEF75% (l/s) M 3-19 0.024×H+0.066×A−2.61 0.562

M 20-90 0.0190×H−0.0356×A−0.1405 0.620

F 3-19 0.027×H+0.032×A−2.68 0.507

F 20-90 0.02×H−0.031×A−0.0062×W−0.212 0.405

PIF (l/s) M 20-90 −0.023×A−0.006×W+1.19×B+3.87

F 20-90 −0.014×A+1.15×B+2.73

MVV (l) M 3-90 1.276×H−99.5

F 3−19 1.276×H−99.5

F 20−90 0.807×H−0.57×A−5.5

FRC (l) M 7-17 0.58×H2.7 ECCS 1

M 25-90 2.348×H+0.009×A−1.093 ECCS 1

F 7-17 0.56×H2.7 ECCS 1

F 25-90 2.245×H+0.001×A−1.003 ECCS 1

Continued…

131

Parameter Sex Age Predicted Equation SD SEE Remarks

RV (l) M 7-17 0.25×H2.7 ECCS 1

M 25-90 1.310×H+0.022×A−1.232 ECCS 1

F 7-17 0.24×H2.7 ECCS 1

F 25-90 1.812×H+0.016×A−2.003 ECCS 1

TLC (l) M 7-17 1.23×H2.7 ECCS 1

M 25-90 7.992×H−7.081 ECCS 1

F 7-17 1.17×H2.7 ECCS 1

F 25-90 6.602×H−5.791 ECCS 1

RV/TLC (%) M 25-90 0.387×A+13.76 ECCS 1

F 25-90 0.335×A+18.96 ECCS 1

BSA (m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

Symbol Definition Unit

A Age years

B BSA m2

H Height cm

H (ECCS) Height m

W Weight kg

1 Equations of the predicted values as ECCS to be applied.

Predicted values between 18 and 24 years are calculated as 25 years.

Reference: 1= :J. Roca, J. Sanchis, A. Agusti-Vidal, F. Segarra, D. Nvajas, R. Rodriguez-

Roisin, P. Casan, S. Sans. Spirometric Reference Values from a Mediterranean Population. BULL EUROP PHYSIOPATHOL RESPIR 1986, 22, 217-224.

2= :Cotes, J. E. Lung Function, 3rd Edition, Blackwell, Oxford, 1975. 3= :George Polgar, M.D. and Varuni Promadhat, M.D. Pulmonary Function

Testing in Children; W. B. Sauders Co., Philadelphia, 1971. 4= :Sorbini, C. A.; Casucci, G.; Todisco, T. BULL PHYSIOPATH RESP; 11,

195P, 1975. 5= :Zapletal, A.; Motoyama, E. K.; v.d. Woestijne, K. P.; Hunt, V. R.; Bouhuys,

A. J. APPL PHYSIOL; 26, 308, 1969. 6= :Taussig, L. M.; Harris, T. R.; Lebowitz, M. D. AM REV RESPIR DIS; 116,

233, 1977. 7= :SPIROMETRIC REFERENCE VALUES FROM A MEDITERRANEAN

POPULATION VALUES SPIROMETRIQUES DE REFERENCE DANS UNE POPULATION MEDITERRANEENNE; J.Roca, J.Sanchis, A.Agusti-Vidal, F.Segarra, D.Navajas, R.Rodriguez-Roisin, P.Casan, S.Sans Bull. Eur. Physiopathol. Respir. 1986, 22, 217-224

ECCS= :Official Statement of the European Respiratory Society. Standardized Lung Function Testing; EUR RESPIR J; 1983, 6, Suppl 16

132

f. JAPAN

Parameter Sex Age Predicted Equation Reference

VC (l) M 6-12 (34.0×H−2487)÷1000 Ishida

M 13 (1.40×A−1.20)×H÷1000 Kanagami

M 14-17 (0.48×A+17.18)×H÷1000 Kanagami

M 18+ (27.63−0.112×A)×H÷1000 Baldwin

F 6-12 (34.3×H−2609)÷1000 Ishida

F 13 (1.70×A−6.70)×H÷1000 Kanagami

F 14-17 (A+3.10)×H÷1000 Kanagami

F 18+ (21.78−0.101×A)×H÷1000 Baldwin

FVC (l) (all) 6+ Pred. VC

FEV1 (l) M 7-17 0.782×H3×10−

6−0.011 J. Bjure

M 18+ 0.0344×H−0.033×A−1.00 Berglund

F 7-17 0.683×H3×10−

6+0.221 J. Bjure

F 18+ 0.0267×H−0.027×A−0.54 Berglund

FEV1%G (%) M 18+ 91.79−0.373×A Berglund

F 18+ 92.11−0.261×A Berglund

MMEF (l/s) M 5-17 (37.01×H−2614)÷1000 Dickman

M 18+ (20.08×H−46×A+2954)÷1000 Schmidt

F 5-17 (34.25×H−2389)÷1000 Dickman

F 18+ (16.93×H−37×A+2243)÷1000 Schmidt

PEF (l/s) M 15+ 0.05666×H−0.02403×A+0.22544 Cherniack

F 15+ 0.03594×H−0.01776×A+1.13160 Cherniack

MEF75% (l/s) M 15+ 0.03555×H−0.01987×A+2.72554 Cherniack

F 15+ 0.02707×H−0.01926×A+2.14653 Cherniack

MEF50% (l/s) M 15+ 0.02569×H−0.03049×A+2.40337 Cherniack

F 15+ 0.02449×H−0.02344×A+1.42640 Cherniack

MEF25% (l/s) M 15+ 0.01411×H−0.04142×A+1.98361 Cherniack

F 15+ 0.00919×H−0.03450×A+2.21596 Cherniack

MVV (l/min) M 11-15 108×BSA−60 Needham

M 16+ (86.5−0.522×A)×BSA Baldwin

F 11-15 77×BSA−24 Needham

F 16+ (71.3−0.474×A)×BSA Baldwin

FRC (l) M 18+ (0.005×A+1.67)×H÷100 Nishida

F 18+ (0.007×A+1.20)×H÷100 Nishida

RV (l) M 18+ (0.010×A+0.55)×H÷100 Nishida

F 18+ (0.009×A+0.42)×H÷100 Nishida

TLC (l) M 18+ 3.40×H÷100 Nishida

F 18+ 2.51×H÷100 Nishida

RV/TLC (%) M 18+ 0.330×A−0.140×W+23.4 Grimby

F 18+ 0.280×A+0.270×H−28.0 Grimby

BSA(m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

Symbol Definition Unit

A Age years

H Height cm

W Weight kg

133

g. NORWAY (OSLO)

Parameter Sex Age Predicted Equation Remarks

VC (l) (all) 7+ Pred. FVC

FVC (l) M 7-14 1.00×H2.7 1, 2, 4

M 25+ −6.679+7.398× H−0.029×A 6

F 7-14 0.95×H2.7 1, 2, 4

F 25+ −4.102+5.220×H−0.021×A 6

FEV1 (l) M 7-14 0.84× H2.7 1, 2, 4

M 25+ −4.540+5.742×H−0.032×A 6

F 7-14 0.81× H2.7 1, 2, 4

F 25+ −1.220+3.278×H−0.027×A 6

FEV1%T (%) M 7-14 84.5 (84.47) 1, 2, 4

M 25+ 89.2−0.183×A 6

F 7-14 84.5 (84.47) 1, 2, 4

F 25+ 145.3−30.75×H-0.248×A 6

MMEF (l/s) M 25+ -4.733+6.081×H-0.044xA 6 F 25+ 5.413-0.051×A 6 PEF (l/s) M 7-14 8.2xH-6.8 1, 3, 4

M 25+ (354xH-1.97xA+9)/60

F 7-14 6.7×H-5.3 1, 3, 4

F 25+ (274xH-2.04xA+59)/60

MEF75% (l/s) M 25+ 5.459×H-0.029xA-0.470 ECCS 1

F 25+ 3.218×H-0.025xA-1.596 ECCS 1

MEF50% (l/s) M 7-14 5.6×H-4.4 1, 3, 4

M 25+ 3.794×H−0.031×A−0.352 ECCS 1

F 7-14 4.6×H-3.3 1, 3, 4

F 25+ 2.45×H−0.025×A+1.156 ECCS 1

MEF25% (l/s) M 25+ 2.605×H-0.026xA-1.336 ECCS 1

F 25+ 1.050×H-0.025xA+1.107 ECCS 1

BSA (m2) (all) W0.425×H0.725×71.84×10-4 Du Bois

Symbol Definition Unit

H Height m

H (BSA) Height m

A Age yrs

W Weight kg 1 Equations of the predicted values as ECCS to be applied.

Predicted values between 15 and 24 years are calculated as 25 years.

Reference:

1= : Cotes, J. E. Lung Function, 3rd Edition, Blackwell, Oxford, 1975. 2= : George Polgar, M.D. and Varuni Promadhat, M.D. Pulmonary Function Testing in

Children; W. B. Sauders Co., Philadelphia, 1971. 3= : Sorbini, C. A.; Casucci, G.; Todisco, T. BULL PHYSIOPATH RESP; 11, 195P, 1975. 4= : Zapletal, A.; Motoyama, E. K.; v.d. Woestijne, K. P.; Hunt, V. R.; Bouhuys, A. J. APPL

PHYSIOL; 26, 308, 1969. 5= : Taussig, L. M.; Harris, T. R.; Lebowitz, M. D.; AM REV RESPIR DIS; 116, 233, 1977. 6= : ECCS= : Official Statement of the European Respiratory Society. Standardized Lung

Function Testing; EUR RESPIR J; 1983, 6, Suppl 16 7= : OBSTRUCTIVE LUNG DISEASE IN AN URBAN POPULATION. Methodological

aspects and prevalence estimates of a cross-sectional survey, and some possible risk factors in Oslo, Norway by AMUND GULSVIK

134

h. CHILE

Parameter Sex Age Predicted Equation Remarks

VC (l) (all) 5+ Pred. FVC

FVC (l) M 5 – 12 -3.4300+0.0429xH

M 13 – 18 -8.8542+0.1572xA+0.0668xH

M 19+ -8.3919-0.0143xA+0.0826xH

F 5 – 12 -3.6955+0.0442xH

F 13 – 20 -6.6843+0.0672xA+0.0588xH

F 21+ -2.8821-0.0205xA+0.0465xH

FEV1 (l) M 5 – 12 -2.6975+0.0353xH

M 13 – 18 -8.4980+0.0927xA+0.0672xH

M 19+ -5.0391-0.0240xA+0.0594xH

F 5 – 12 -3.2392+0.0391xH

F 13 – 20 -5.4527+0.0332xA+0.0519xH

F 21+ -1.1219-0.0264xA+0.0327xH

FEV1%T (%) M 5 – 12 103.6481+(-0.1147xH)

M 13 – 18 71.077+(-0.8651xA)+(0.1821xH)

M 19+ 74.564+(-0.2614xA)+(0.0996xH)

F 5 – 12 96.073+(-0.0451xH)

F 13 – 20 103.892+(-0.6766xA)+(-0.023xH)

F 21+ 114.015+(-0.2895xA)+(-0.1306xH)

MMEF (l/s) M 5 – 12 -2.7763+0.0388xH

M 13 – 18 -10.6613+0.0927xH

M 19+ 0.1980-0.0496xA+0.0347xH

F 5 – 12 -4.3043+0.0514xH

F 13 – 20 -4.2533+0.0525xH

F 21+ 5.1952-0.0517xA

Symbol Definition Unit

H Height cm

A Age yrs

W Weight kg

135

i. AUSTRIA

Parameter Sex Age Predicted Equation Remarks

VC (l) (all) Pred. FVC

FVC (l) M ≤ 17 e(-1.142+1.259xH+0.004070xAx(W½))

M ≥ 18 -11.606+8.172xH-0.0339xAxH+1.2869xln(A)

F ≤ 15 e(-3.842+4.1632x(H½)+0.1341x(A½)-1.614xFi)

F ≥ 16 -10.815+6.640xH-0.0408xAxH+1.7293xln(A)

FEV1 (l) M ≤ 17 e(-1.178+1.221xH+0.003841xAx(W½))

M ≥ 18 -8.125+6.212xH-0.0300xAxH+0.9770xln(A)

F ≤ 15 e(-3.877+3.9809x(H½)+0.1485x(A½)-1.322xFi)

F ≥ 16 -6.995+5.174xH-0.0314xAxH+1.0251xln(A)

FEV1%G (%) M ≤ 17 101.99-1.191x(H2)-3.962xln(A)

M ≥ 18 101.99-1.191x(H2)-3.962xln(A)

F ≤ 15 92.33

F ≥ 16 118.993-3.0320x(H2)-6.9053xln(A)

PEF (l/s) M ≤ 17 e(-0.214+0.921xH+0.0467xA+0.0020xW)

M ≥ 18 (1.798+2.311xln(H)+0.0159xA-0.000248x(A2)) 2

F ≤ 15 e(-0.411+1.793xln(H)+0.4251xln(A)-0.910xFi)

F ≥ 16 (1.832+1.838xln(H)+0.0078xA-0.000172x(A2)) 2

MEF75% (l/s) M ≤ 17 e(-0.077+0.770xH+0.0373xA+0.0025xW)

M ≥ 18 (1.581+1.854xln(H)+0.0213xA-0.000283x(A2)) 2

F ≤ 15 e(0.455+1.616xln(H)+0.3738xln(A)-0.861xFi)

F ≥ 16 (1.779+1.421xln(H)+0.0096xA-0.000179x(A2)) 2

MEF50% (l/s) M ≤ 17 e(-0.522+0.843xH+0.0300xA+0.0035xW)

M ≥ 18 (1.490+1.290xln(H)+0.0125xA-0.000218x(A2)) 2

F ≤ 15 e(0.256+1.643xln(H)+0.3481xln(A)-1.089xFi)

F ≥ 16 (1.561+1.177xln(H)+0.0045xA-0.000140x(A2)) 2

MEF25% (l/s) M ≤ 17 e(-1.576+1.166xH+0.0219xA+0.0021xW)

M ≥ 18 (1.314+0.898xln(H)-0.0083xA-0.000026x(A2)) 2

F ≤ 15 e(-0.722+2.002xln(H)+0.3063xln(A)-0.409xFi)

F ≥ 16 (1.372+0.938xln(H)-0.0152xA+0.000036x(A2)) 2

TLC (l) M ≤ 17 (1.388-0.077xH)xPred. VC

M ≥ 18 (1.1340+0.0053xA)x Pred. VC

F ≤ 15 (1.388-0.077xH)x Pred. VC

F ≥ 16 (1.2413+0.0036xA)x Pred. VC

Symbol Definition Unit Range

H Height m M ≤ 17 1.09 – 1.96 m

M ≥ 18 1.44 – 2.00 m

F ≤ 15 1.10 – 1.82 m

F ≥ 16 1.40 – 1.90 m

A Age yrs M; F 5 – 90

W Weight kg

Fi H/W2/3

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j. FINLAND

Parameter Sex Age Predicted Equation Remarks

VC(L) M 6 - 17 e(-13.2807+2.8671*ln(H))

M 18 + 10(-0.00833*A+0.6309*logA-1.4750/H+0.9047)

F 6 - 17 e(-13.7284+2.9423*ln(H))

F 18 + 10(-0.01016*A+0.6995*logA-1.4518/H+0.7763)

FVC (l) M 6 - 17 e(-13.4611+2.9092*ln(h))

M 18 + 10(-0.00827*A+0.5860*logA-1.4468/H+0.9461)

F 6 - 17 e(-13.6800+2.9423*ln(H))

F 18 + 10(-0.00982*A+0.6358*logA-1.4137/H+0.8320)

FEV0.5 (l) M 6 - 17 e(-13.1243+2.7586*ln(H)

F 6 - 17 e(-13.8074+2.8893*ln(H)

FEV1 (l) M 6 - 17 e(-13.1086+2.8141*ln(H))

M 18 + 10(-0.00587*A+0.2756*logA-1.1655/H+1.0980)

F 6 - 17 e(-13.6918+2.9229*ln(H))

F 18 + 10(-0.00920*A+0.4772*logA-1.3284/H+0.9296)

FEV0.5/FVC(%) M 6 - 17 (0.7597×H-0.0006)×100 *1

F 6 - 17 (0.7377×H-0.0004)×100 *1

FEV1/FVC(%) M 6 - 17 (0.9643×H-0.0005)×100

M 18 + 10(0.00240*A-0.3104*logA+0.2813/H+2.1519)

F 6 - 17 (0.9152×H-0.0001)×100

F 18 + 10(0.00062*A-0.1586*logA+0.0853/H+2.0975)

FEV1/VC(%) M 18 + 10(0.00246*A-0.3553*logA+0.3095/H+2.1933)

F 18 + 10(0.00096*A-0.2223*logA+0.1233/H+2.1533)

PEF (L/S) M 6 - 17 e(-12.8067+2.8864*ln(H))

M 18 + 10(-0.00211*A+0.1049*logA-0.6774/H+1.3255)

F 6 - 17 e(-13.7766+3.0746*ln(H))

F 18 + 10(-0.00677*A+0.4017*logA-0.7422/H+0.9661)

MEF50%(L/S) M 6 - 17 e(-12.0970+2.6616*ln(H))

M 18 + 10(-0.00041*A-0.3087*logA-0.1480/H+1.3415)

F 6 - 17 e(-13.2387+2.8860*ln(H))

F 18 + 10(-0.00741*A+0.3471*logA-0.8581/H+0.9336)

MEF25% (l/s) M 18 + 10(-0.00771*A-0.2819*logA-0.0252/H+1.0597)

F 18 + 10(-0.01548*A+0.3431*logA-0.8498/H+0.7966)

PIF(L/S) M 18 + 10(-0.00484*A+0.2715*logA-0.9965/H+1.2709)

F 18 + 10(-0.00909*A+0.6156*logA-1.1867/H+0.8731)

*1 This is not measurement parameter, predicted value is not displayed and not printed.

Symbol Definition Unit Range Remarks

H Height cm Pediatrics: 6 – 17 Pediatric equation: Koillinen H et. al. 1998

m Adults: 18 + Adult equation: Viljanen AA et al 1982

A Age yrs Pediatrics: 6 – 17 Pediatric equation: Koillinen H et. al. 1998

Adults: 18 + Adult equation: Viljanen AA et al 1982

W Weight kg

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APPENDIX 2. Interpretation Algorithms a. Intermountain Thoracic Society (ITS) In selecting this interpretation algorithm, the recommendation may be concluded from either using the ATS or NIOSH/OSHA measurement data selection criteria. Setting may be made at the Util-System Mode-Dsel menu. When selected, the issued interpretation message follows the below formulated interpretation algorithm:

Criteria Message 1 Predicted FEV1%G2 – Actual FEV1%G ≥ 4CI3 Severe airway obstruction. 2 Predicted FEV1%G – Actual FEV1%G ≥ 2CI Moderate airway obstruction. 3 Predicted FEV1%G – Actual FEV1%G ≥ 1CI Mild airway restriction. 4 Predicted FEV3%G 4– Actual FEV3%G ≥ 4CI Airway obstruction suggested Low

FEV3/FVC. 5 Obstructive and Ex Time ≤ 5 seconds Obstruction may be

underestimated-Expiration time less than 5 seconds.

6 Obstructive and No Post Data Order pre- and post-bronchodilator spirometry if clinically indicated.

7 FEV.5/FEV1 < 0.6 Upper airway obstruction suggested.

8 Ex Time ≤ 1.1 and FVC (Pre/Post) ≥ 1.25 FEV.5 (Pre/Post) or FEV1 (Pre/Post) ≥ 1.25 FEF = 0 and FEF25-75 ≥ 2

Spirometry markedly improved after post bronchodilator.

9 Ex Time ≤ 1.1 and FVC (Pre/Post) ≥ 1.15 FEV.5 (Pre/Post) or FEV1 (Pre/Post) ≥ 1.12 FEF = 0 and FEF25-75 ≥ 1.45

Spirometry improved after post bronchodilator.

10 Ex Time ≤ 1.1 and FEV.5 (Pre/Post) ≥ 1.05 Ex Time ≤ 1.1 and FEV1 (Pre/Post) ≥ 1.05 FEF = 0 and FEF25-75 ≥ 1.1

Spirometry not clearly improved post bronchodilator.

11 Ex Time ≤ 1.1 and FVC (Pre/Post) < 1.05 FEV.5 (Pre/Post) or FEV1 (Pre/Post) < 1.05 FEF = 0 and FEF25-75 < 1.1

Spirometry not improved after post bronchodilator.

12 Predicted FEV1%G – Actual FEV1%G ≥ 2CI Severe airways restriction. 13 Predicted FEV1%G – Actual FEV1%G ≥ 2.5CI Moderate airways restriction. 14 Predicted FEV1%G – Actual FEV1%G ≥ 1.75CI Mild airways restriction. 15 Ex Time > 1.1 and Predicted FEV1%G – Actual

FEV1%G ≥ 1.75CI and Ex Time (Pre) ≥ 3 seconds

Normal spirometry.

16 Ex Time > 1.1 and Predicted FEV1%G – Actual FEV1%G ≥ 1.75CI and Ex Time (Pre) < 3 seconds

Probably normal spirometry. *Short exhalation may hide mild *obstruction.

17 Predicted FEV1%G – Actual FEV1%G ≥ CI and Predicted FEV1%G – Actual FEV1%G ≥ 1.75CI

Chest restriction may also be present; suggest lung volume and DLCO.

18 Predicted FEV1%G – Actual FEV1%G ≥ CI and Predicted FEV1%G – Actual FEV1%G < 1.75CI

Order lung volume and DLCO if clinically indicated.

19 FEV.5%T (Pre) < 0.56 Low FEV.5 suggests poor initial effort.

2 FEV1%G = FEV1/FVC 3 CI = Confidence Interval (statistical label) 4 FEV3%G = FEV3/FVC

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20 MVV > 1.1 and (MVV / 41 x FEV1 (Pre) < 0.8 MVV low relative to FEV1 suggests poor initial effort and/or neuromuscular disorder.

21 Out of range in age. 22 Out of range in height. 23 Out of range in age and height.

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b. ELLIS In selecting this interpretation algorithm, the recommendation may be concluded from either using the ATS or NIOSH/OSHA measurement data selection criteria. Setting may be made at the Util-System Mode-Dsel menu. When selected, the issued interpretation message follows the below formulated interpretation algorithm:

Criteria Message 1 FEV1/FVC < 65% Severe obstructive lung disease. 2 FEV1/FVC < 84% Moderate obstructive lung disease. 3 FEV1/FVC < 100% Mild obstructive lung disease. 4 Actual FVC / Predicted FVC < 44% Severe restrictive lung disease. 5 Actual FVC / Predicted FVC < 80% Restrictive lung disease cannot be excluded

by spirometry alone. 6 Actual FVC / Predicted FVC < 64% Moderate restrictive lung disease. 7 Actual FVC / Predicted FVC < 80% Mild restrictive lung disease. 8 FEF25-75 > 0 Probably spirometry within normal limits. No

predicted value of MMEF cannot judge early small airway obstruction.

9 FEF25-75 < 70% Early small airway obstruction. 10 FEF25-75 ≥ 70% Spirometry within normal limits. Actual FVC / Predicted FVC < 80% Restrictive lung disease cannot be excluded

by spirometry alone. 11 Post Test Done Following Bronchodilator 12 FVC increase ≥ 0.2 liters FVC increased by X.XX L 13 FEV1 increase ≥ 0.1 liters FEV1 increased by X.XX L 14 FEF25-75 increase ≥ 0.25 L/S MMEF increased by X.XX L/S 15 FVC increase < 0.2 liters

FEV1 increase < 0.1 liters FEF25-75 increase < 0.25 L/S

No change after bronchodilator.

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c. DIAGNOSIS The DIAGNOSIS interpretation uses four rectangular quadrants. Each quadrant is defined to satisfy a particular diagnostic outcome namely: restrictive, normal, mixed, and obstructive. An asterisk on the relevant quadrant designates the interpretation result.

1) Diagnosis judgment is primarily made from %VC of predicted and FEV1/VC (FEV1%T). 2) In the absence of VC values, %FVC of predicted and FEV1/FVC (FEV1%G) is used

instead. Please note however the over-estimation error for patients with obstructive characteristics.

3) When no patient demographic data is registered, no interpretation is issued.

Item Criteria Message

1) %VC (%FVC)� 80� & FEV1%T (FEV1%G) � 70� NORMAL (Nor)

2) %VC (%FVC) < 80� & FEV1%T (FEV1%G) � 70� RESTRICTIVE (Res)

3) %VC (%FVC)� 80� & FEV1%T (FEV1%G) < 70� OBSTRUCTIVE (Obst)

4) %VC (%FVC) < 80� & FEV1%T (FEV1%G) <70� MIXED (Mixed)

Typical display of the Diagnosis Interpretation 4) In the LCD and hardcopy display, the judgment result is marked with an * in the

particular quadrant. In classifying for an obstructive ventilator defect, extreme care should be exercised when making an absolute conclusion in the gray band area (located by the 70~80% scale of the FEV1% axis). The lower limit of normal (LLN) of FEV1% is usually around 70~75% but the exact limit varies with age and sex.

Typical display of the Diagnosis Interpretation

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d. GOLD COPD For Initial Spirometry: The GOLD interpretation for initial spirometry uses a five segment open quadrilateral. Each segment is defined to satisfy a particular COPD severity diagnostic stage condition. An asterisk on the relevant segment designates the interpretation result using the following specification:. For Initial Spirometry:

1. Use mMeasured FVC, measured FEV1, and computed predicted FEV1/FVC and predicted FEV1 for evaluationwere used for evaluation.

2. Both measured FVC and FEV1 should are be the largest value obtained from any three (3) technically satisfactory curves: and,

3. The FVC and FEV1 values in the curves should vary by no more that 5% or 100ml, whichever is greater.

Criteria Message Remark

FEV1/FVC ≥ 70% Predicted FEV1 ≥ 80% Predicted

Stage 0 Normal Spirometry - At Risk when chronic symptoms present.

FEV1/FVC < 70% Predicted FEV1 ≥ 80% Predicted

Stage I Mild COPD.

FEV1/FVC < 70% Predicted 50% Predicted ≤ FEV1 < 80% Predicted

Stage II Moderate COPD – Confirm reversibility by Bronchodilation.

FEV1/FVC < 70% Predicted 30% Predicted ≤ FEV1 < 50% Predicted

Stage III Severe COPD - COPD severity increased with chronic respiratory failure.

FEV1/FVC < 70% Predicted FEV1 <30% Predicted or FEV1 < 50% Predicted + chronic respiratory failure

Stage IV Very Severe COPD

Typical display of the GOLD (Initial-Pre) Interpretation

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For Post Bronchodilator: The GOLD interpretation for post measuring spirometry either issues the same five-segment severity chart or a reversibility message using the following specification:

1. Use tThe baseline data satisfying the condition FEV1/FVC < 70% Predicted + FEV1 < 80% of predicted was used for determining the reversibility message; and, for comparison with the post (bronchodilator) data.

2. Use tThe prior Initial spirometry message is re-issued if the baseline data does not satisfy the above conditions.

Criteria Message Remark

(Post FEV1 - Pre FEV1) > 200ml and ((Post FEV1 - Pre FEV1) / (Pre FEV1)) ≥ 12%

Reversible Reversible Airflow Limitation.

(Post FEV1 - Pre FEV1) ≤ 200ml and ((Post FEV1 - Pre FEV1) / (Pre FEV1)) < 12%

Irreversible Irreversible Airflow Limitation.

Typical display of the GOLD (Post) Interpretation

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APPENDIX 3. Bronchial Challenge Dosage Templates

1. Standard dilution schedule and inhalation units for Methacholine

Methacholine concentrations

(mg/ml)

No. of breaths

Inhalation units per 5

breaths 0.075 5 0.375 0.150 5 0.750 0.310 5 1.550 0.620 5 3.100 1.250 5 6.250 2.500 5 12.500 5.000 5 25.000 10.000 5 50.000 25.000 5 125.000

2. Standard dilution schedule and inhalation units for Histamine

Histamine base concentrations

(mg/ml)

No. of breaths

Inhalation units per 5

breaths 0.030 5 0.150 0.060 5 0.300 0.120 5 0.600 0.250 5 1.250 0.500 5 2.500 1.000 5 5.000 2.500 5 12.500 5.000 5 25.000 10.000 5 50.000

3. Standard dilution schedule and inhalation units for Antigens

Antigen concentration

No. of breaths

Inhalation units per 5

breaths 1:1x10exp6 5 0.025 1:5x10exp5 5 0.050 1:1x10exp5 5 0.250 1:5x10exp4 5 0.500 1:1x10exp4 5 2.500 1:5x10exp3 5 5.000 1:1x10exp3 5 25.000 1:5x10exp2 5 50.000

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APPENDIX 4. Trouble Shooting

1). Q: Power to instrument does not switch on. A: Power Cord is disconnected or loosely inserted.

Securely connect the Power Cord to the instrument.

A: Blown AC line fuse(s). Replace blown fuse(s).

2). Q: Upon power-up, measurement modes are inhibited. A1: “Flow base” detection error reported by Flow Sensor.

Secure Spirette tube into position.

A2. Flow base” detection error reported by Flow Sensor. Block the Spirette tube while powering –up.

A3. Flow base” detection error reported by Flow Sensor. Replace TrueFlow Flow Sensor.

3). Q: Unable to print or feed paper. A: The printer cover has remained opened.

Press the printer cover until a click sound is heard.

4). Q: No imprints come out on the thermal recoding paper during printing. A: Thermal recording paper is positioned inversely.

Re-insert the thermal recording paper with the printing surface outward.

5). Q: Unable to perform Post-Measurement or BC-measurement. A: No pre measurement (baseline) data loaded.

Before performing Post-Measurement, have a VC, FVC or MVV baseline data. Before performing BC measurement, have an FVC baseline data.

6). Q: Unable to edit (modify patient information in Post or BC Measurement. A: Editing patient information during Post or BC Measurement is not allowed.

7). Q: FRC-related items not analyzed or displayed. A1: The FRC input mode is off.

Turn the FRC mode on.

A2: The FRC value column is blank (omission or out of range). Analysis cannot be made unless the FRC value is between 0.1 to 5.00 liters.

8). Q: Date is not accurate or is displayed as garbage. A: Backup internal battery may be exhausted.

Replace the back-up battery.

9). Q: Unable to delete saved data.

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A: You tried to delete a pre-measurement (baseline data) that is linked to a post or BC-measurement data. The pre-measurement (baseline data) linked to a saved post or BC measurement cannot be deleted. Delete all linked post or BC measurement data prior to deleting the pre-measurement data. Always confirm measurement data before deleting as measurement data once deleted cannot be recovered.

10). Q: Unexpected malfunctioning. A: External EMI noise affecting the instrument.

While this instrument complies with the IEC 601-1-2 standard on EMC, it may still malfunction when present in an environ where noise exceeds the test standards. Use the instrument away from noise-generating equipment.

11). Q: When uploading measurement data, error message is displayed. A: Serial Communication Cable disconnected.

Connect cable properly.