innocor instructions for use - innovision 11.5.8 flowmeter sensor ... or any other penetration...

INSTRUCTIONS FOR USE

COR-MAN-0000-001-IN / EN

Issue D, Rev. 1

2015-10-01

S/W version 8.00

INNOVISION ApS

Skovvænget 2

DK-5620 Glamsbjerg

Denmark

Tel.: +45 65 95 91 00

Fax: +45 65 95 78 00

[email protected]

www.innovision.dk

Innovision Innocor® Instructions for Use

October 2015 COR-MAN-0000-001-IN /EN, D/1 i

TABLE OF CONTENTS

ABOUT THIS MANUAL ...................................................................................................................... 1

1. INTRODUCTION TO INNOCOR ..................................................................................................... 1

1.1 INTENDED USE ..................................................................................................................................... 1

1.2 INTENDED APPLICATIONS AND PATIENT POPULATION .............................................................. 3

1.3 INTENDED OPERATORS AND ENVIRONMENT ................................................................................. 3

1.4 DISCLAIMER ......................................................................................................................................... 3

2. PRODUCT OVERVIEW AND INSTALLATION .............................................................................. 4

3. SYMBOLS ..................................................................................................................................... 11

4. ATTENTION .................................................................................................................................. 15

5. WARNINGS ................................................................................................................................... 19

5.1 GENERAL ............................................................................................................................................. 19

5.2 SAFETY CLASSIFICATION ................................................................................................................. 19

5.3 ELECTRICAL........................................................................................................................................ 19

5.4 ENVIRONMENTAL............................................................................................................................... 20

5.5 PROCEDURAL ..................................................................................................................................... 20

6. OPERATING ENVIRONMENT ..................................................................................................... 21

7. SHORT INSTRUCTIONS .............................................................................................................. 22

7.1 MAIN SCREEN ..................................................................................................................................... 22

7.2 CALIBRATION...................................................................................................................................... 22

7.3 MEASUREMENT (CO BY REBREATHING / CPET PROGRAM) ....................................................... 25 7.3.1 Operating Principle ....................................................................................................................... 25 7.3.2 Start of Rebreathing / CPET Program ........................................................................................... 25 7.3.3 Patient Database ............................................................................................................................ 26 7.3.4 Test Preparation ............................................................................................................................ 26 7.3.5 Test Execution ............................................................................................................................... 26 7.3.6 Option: Breath-by-Breath .............................................................................................................. 27 7.3.7 Rebreathing Test ........................................................................................................................... 27 7.3.8 Results ........................................................................................................................................... 28 7.3.9 After a Test .................................................................................................................................... 35 7.3.10 Setup ............................................................................................................................................ 36 7.3.11 Data Exchange ............................................................................................................................. 36 7.3.12 Blood Pressure Test (Stand-Alone) ............................................................................................. 36 7.3.13 Recommended Settings ............................................................................................................... 37 7.3.14 Termination of Program .............................................................................................................. 37

7.4 MEASUREMENT (LCI BY MULTIPLE-BREATH WASH-OUT) .......................................................... 38 7.4.1 Operating Principle ....................................................................................................................... 38 7.4.2 Start of LCI Program ..................................................................................................................... 38 7.4.3 Patient Selection ............................................................................................................................ 38 7.4.4 General Screen Layout .................................................................................................................. 39 7.4.5 Test Preparation ............................................................................................................................ 40


October 2015 COR-MAN-0000-001-IN /EN, D/1 ii

7.4.6 Test Execution ............................................................................................................................... 41 7.4.7 Results ........................................................................................................................................... 45 7.4.8 After a Test .................................................................................................................................... 48 7.4.9 Setup .............................................................................................................................................. 48 7.4.10 Calibration ................................................................................................................................... 49 7.4.11 Data Exchange ............................................................................................................................. 49 7.4.12 Recommended Settings ............................................................................................................... 49 7.4.13 Termination of Program .............................................................................................................. 50

8. RVU DESCRIPTION ..................................................................................................................... 51

8.1 OPERATING PRINCIPLE .................................................................................................................... 51

8.2 VALVE INSERT .................................................................................................................................... 52

8.3 FLOW RESTRICTOR ............................................................................................................................ 53

8.4 RVU TEST ............................................................................................................................................. 54

8.5 SPIROMETRY MODE .......................................................................................................................... 54

8.6 LCI MODE / CO2 SCRUBBER ............................................................................................................. 55

9. PULSE OXIMETRY ....................................................................................................................... 56

9.1 OPERATING PRINCIPLE .................................................................................................................... 56

9.2 ATTACHING THE SENSOR ................................................................................................................. 56

9.3 ACCURACY .......................................................................................................................................... 57

9.4 PRECAUTIONS FOR USE ................................................................................................................... 57

9.5 CONTRAINDICATIONS ....................................................................................................................... 57

10. BLOOD PRESSURE ................................................................................................................... 58

10.1 OPERATING PRINCIPLE .................................................................................................................. 58

10.2 PERFORMANCE ................................................................................................................................ 58

10.3 POSITIONING THE CUFF ................................................................................................................ 58

10.4 PRECAUTIONS FOR USE ................................................................................................................. 59

11. CLEANING AND MAINTENANCE .............................................................................................. 60

11.1 REPLACEMENT OF GAS ANALYSER FILTERS ............................................................................... 60

11.2 REPLACEMENT OF GAS ANALYSER SAMPLING TUBE ................................................................ 60

11.3 REPLACEMENT OF RESPIRATORY PARTS .................................................................................... 60

11.4 CLEANING AND REPLACEMENT OF DUST FILTER FOR COOLING FAN ................................. 60

11.5 CALIBRATIONS.................................................................................................................................. 61 11.5.1 Gas Analyser Calibration............................................................................................................. 61 11.5.2 Oxygen Sensor Calibration .......................................................................................................... 61 11.5.3 Airway Pressure Sensor Calibration ............................................................................................ 61 11.5.4 Rebreathing Gas Filling Flow Calibrations ................................................................................. 61 11.5.5 Gas Cylinder Pressure Sensor Calibration ................................................................................... 61 11.5.6 Pulse Oximeter Calibration ......................................................................................................... 61 11.5.7 Non-Invasive Blood Pressure Calibration ................................................................................... 61 11.5.8 Flowmeter Sensor Calibration ..................................................................................................... 62 11.5.9 Flow-gas delay Calibration .......................................................................................................... 62


October 2015 COR-MAN-0000-001-IN /EN, D/1 iii

11.6 CLEANING ......................................................................................................................................... 62 11.6.1 General ........................................................................................................................................ 62 11.6.2 Casing .......................................................................................................................................... 62 11.6.3 LCD / Touch Screen Display....................................................................................................... 62 11.6.4 Cleaning and Maintenance of RVU ............................................................................................. 62 11.6.5 Cleaning of Respiratory Parts ...................................................................................................... 63 11.6.6 Cleaning of Gas Analyser Sampling Tube ................................................................................... 63 11.6.7 Cleaning of Pulse Oximetry Sensor ............................................................................................. 64 11.6.8 Cleaning of NIBP Cuff (Option) ................................................................................................. 64 11.6.9 External Computer ...................................................................................................................... 64

12. PERIODICAL CHECKS .............................................................................................................. 65

12.1 INSPECTION ...................................................................................................................................... 65

12.2 PERFORMANCE CHECK .................................................................................................................. 65

12.3 SAFETY CHECK ................................................................................................................................. 65

13. DISASSEMBLY AND DISPOSAL ............................................................................................... 66

13.1 DISASSEMBLY PROCEDURE ........................................................................................................... 66

13.2 DISPOSAL OF DEVICE AND ACCESSORIES .................................................................................. 67

14. SPECIFICATIONS ...................................................................................................................... 68

15. ACCESSORIES .......................................................................................................................... 73

Annex A Guidance and manufacturer’s declaration


October 2015 COR-MAN-0000-001-IN /EN, D/1 1

ABOUT THIS MANUAL NOTE: Before using Innocor please read this manual thoroughly. Pay special attention to WARNING!

and CAUTION statements appearing throughout the manual and to the ATTENTION section. A warning (indicated with the word WARNING!) alerts about a situation which, if not avoided, could result in death or serious injury to the user or the patient. It also describes potential serious adverse reactions and safety hazards.

A precaution statement (indicated with the word CAUTION) is used for a hazard alert that warns of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. It is also used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse.

In the following all functions and options of Innocor are described. Some of the functions described or shown may not be available on the device you are using.

1. INTRODUCTION TO INNOCOR

1.1 INTENDED USE

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of cardiac output and related cardiopulmonary parameters. Cardiac output (CO) is defined as the volume of blood pumped by the heart per unit of time (blood flow in litre per minute). The measurement is non-invasive (i.e. does not necessitate catheterisation or any other penetration through a body orifice or the body surface) in that it is based on a pulmonary gas exchange method called inert gas rebreathing (IGR).

The operating principle of Innocor is to let the patient breathe minute quantities of a blood soluble and an insoluble gas in a closed breathing assembly for a short period. The blood flowing through the lungs (effective pulmonary blood flow, PBF) absorbs the blood soluble gas and therefore the disappearance rate is proportional to the blood flow. Other factors affecting the distribution of the blood soluble gas are accounted for by also measuring the blood insoluble gas. The spontaneously breathing patient puts on a nose clip and breathes into a respiratory valve via a mouthpiece and bacterial filter. At the end of expiration the valve is activated so that the patient will breathe in and out (rebreathe) from a rubber bag for a period of 10-20 seconds. The patient is asked to empty the bag during each inspiration and breathe with a slightly increased respiration rate. After this period the patient is switched back to ambient air and the test is terminated. The bag is prefilled with an oxygen (O2) enriched mixture containing two foreign gases; typically 0.5% nitrous oxide (N2O) and 0.1% sulphur hexafluoride (SF6). These gases and CO2 are measured continuously and simultaneously at the

mouthpiece by a photoacoustic gas analyser inside Innocor. N2O is soluble in blood and is therefore absorbed during the blood’s passage of the lungs at a rate, which is proportional to the blood flow. So, the higher the cardiac output the higher the disappearance rate (slope of measured gas curve). SF6 is insoluble in blood and therefore stays in the gas phase and is used to determine the lung volume from which the soluble gas is removed. The rebreathing test can be performed as a single test at rest or at a given exercise level using e.g. a bicycle ergometer or a treadmill in a stand-alone configuration. Alternatively it can be performed as a part of an exercise protocol where the rebreathing manoeuvres are done at pre-programmed intervals/workloads.



By using a pulse oximeter the heart rate (HR) can be measured during the test and used to derive the stroke volume (SV) etc. The arterial oxygen saturation (SpO2) indicates whether the oxygenation is normal and thus if there is a significant intrapulmonary shunt (SpO2 < 95%). An oscillometric non-invasive blood pressure (BP) measuring system is also included as an option. It is designed to take blood pressure measurements including systolic (SYS), diastolic (DIA) and mean arterial pressures (MAP). By combining CO and MAP the systemic vascular resistance (SVR) can be determined. The BBB (Breath-by-Breath) option provides measurements of gas exchange parameters including oxygen uptake, carbon dioxide excretion, ventilation and end-tidal concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests. This gives the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time. The Spirometry option provides measurements of the lung function with respect to dynamic lung volumes during forced expiration. This includes FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), FEV1%, PEF (peak expiratory flow), MEF 75 (Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired), MEF 50, MEF 25, FET (Forced expiratory time) and MVV (Maximum voluntary ventilation). These parameters are determined by measurements of the respiratory flow when breathing ambient air during a spirometry manoeuvre (tidal breathing followed by first a full inspiration then a maximal forced expiration). The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed in a stand-alone position to minimise the flow resistance. This gives the opportunity to perform a diagnosis after an exercise test: Is the patient’s exercise intolerance caused by ventilatory limitation or is the abnormality caused by a limitation in the cardiovascular system? The LCI Option provides assessment of the ventilation distribution in a patient’s lungs by recording of an inert gas multiple-breath washout (MBW) curve. The primary parameter measured is the Lung Clearance Index (LCI), which is the cumulative expired volume required to clear the inert gas from the lungs during normal breathing divided by the Functional Residual Capacity (FRC). The manoeuvre performed is similar to inert gas rebreathing (IGR) described above. The manoeuvre is only extended to monitor the breathing in the washout period (breathing normal air) after the rebreathing period. FRC and LCI are determined by combining the rebreathing test with the multiple-breath inert gas washout in open-circuit mode. During these combined tests the respiratory flow and SF6 concentration are measured during tidal breathing. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer). The SF6 concentration is measured by means of a photoacoustic infrared analyzer. An oxygen enriched rebreathing gas mixture for wash-in of SF6 is automatically filled into a rubber bag prior to testing by adding a bolus of mixture to air. When the SF6 is adequately equilibrated in the lungs during rebreathing the test continues by letting the patient breathe ambient air in the multiple-breath wash-out period until the end-tidal SF6 concentration has fallen below 1/40 of the starting concentration.

Innocor runs under the Windows XP Embedded operating system on an integrated single-board computer or under Windows on an external computer/tablet. However, knowledge of Windows is not required to operate the device. The device is operated via a simple touch screen interface.



1.2 INTENDED APPLICATIONS AND PATIENT POPULATION

Innocor can be used in a variety of medical fields where knowledge of cardiac output and gas exchange is important, e.g. cardiac exercise stress testing, heart failure, cardiac surgery, hypertension, pulmonary hypertension, hemodialysis and pacemaker programming. It can be used both in rest and exercise e.g. with patients who have no symptoms in rest or light exercise. The method involves no risk or pain to the patient. The only requirement is that the patient is capable of understanding the instructions from the operator and performing the manoeuvre well.

1.3 INTENDED OPERATORS AND ENVIRONMENT

The Innocor should be used only by professional health care providers who have received training in the use of the equipment.

Equipment specific training is required for the primary operating functions of Innocor. Two to four hours of on-site training is typically offered by the manufacturer or its representative during installation.

1.4 DISCLAIMER INNOVISION (the manufacturer) considers itself responsible for effects on safety, reliability and performance of this equipment only if:

Persons authorised by the manufacturer carry out assembly, extensions, readjustments, modifications or repairs.

The parts and components used for repairs, modifications, extensions or local applications are of a type approved by the manufacturer.

The electrical installation to which the equipment is connected complies with appropriate requirements.

Accessories listed in the Instructions for Use are used.

The equipment is used in accordance with the Instructions for Use. The device contains no internal user-serviceable components. In the event of failure or defect, contact the manufacturer or his representative.



2. PRODUCT OVERVIEW AND INSTALLATION Do not connect anything or turn anything on before you have become fully familiar with the contents of this chapter on installation.

Innocor is shown in figure 1a and 1b. Depending on the configuration of the device it may look different from what is shown in this and the following figures.

1) Colour LCD / Touch Screen* 2) Patient Interface Panel 3) Cooling Air Inlet * For devices with external computer, see figure 1b.

1) Lifting Slot 2) Cooling Air Outlet 3) Gas Cylinder Connection 4) Power Interface Panel 5) Data Interface Panel

FIGURE 1a. Left) Right side view, Right) Rear view. The rear panel to the left is the power interface panel (figure 2) for the mains AC power input.

2

1

3

2

4 5

3

1



FIGURE 1b. Innocor version with external computer (tablet).

FIGURE 2. Power interface panel for the mains AC power input.

Connect an earthed mains power cord to the 230 V / 110 V input. The rear panel to the right is the data interface panel (figure 3).



FIGURE 3. Data interface panel. Upper: Innocor version with integrated computer and network connection. Lower: Innocor version with external computer (tablet) equipped with a USB type B connector and earth terminal screw (with cable connected to the right). For versions using an external computer, connect the computer using the USB type B connector to the right on the Data interface panel. Also, connect the earth wire to the earth terminal and tighten using a tool. Connect the USB type A end of the cable to the computer. WARNING! If using a version with external computer, the computer must be certified according to the European standard EN 60950. The computer should only be used on battery power. Otherwise, it is required to use a safety isolating transformer. The computer must be placed outside of the patient zone. Make sure not to block the gas outlet/inlet connector when installing the device. Remove protective plugs from the gas outlet/inlet connectors if mounted. Before connecting the gas cylinder to the fitting in the lower middle of the rear part (figure 1), ensure that an intact o-ring is in place (figure 4). Connect the gas cylinder to the fitting (figure 5) by hand tightening. NOTE: When the valve opens automatically extra torque is required to screw the cylinder onto the device (an additional approx. 2 turns).



FIGURE 4. Gas cylinder connection, position (left) and cross sectional view (right). Note correct positioning of O-ring seal (right).

FIGURE 5. Innocor with gas cylinder mounted and RVU in storage position. The right side panel is the patient interface panel (figure 6).



FIGURE 6. Patient interface panel. Left) Shown without connections Right) Shown with connections. Connect the six-tube quick connector to the rebreathing valve unit hose connection on the side panel (it clicks on). Connect the gas analyser sampling tube to the gas inlet connection. Make sure to use a particle filter between the gas inlet connection (analyser) and the sampling tube. The filter has a male slip luer adapter on the analyser side and a female locking luer connector on the sampling tube side. Make sure the filter (membrane) is not contaminated (grey or black) inside. Guide the gas analyser sampling tube along the flexible tubing to the rebreathing valve unit, making sure not to kink or damage the sampling tube. Connect the pulse oximeter finger probe to the D-sub connector marked SpO2 on the side panel. Connect the NIBP arm cuff to the NIBP quick connector on the side panel using the air hose (optional). The rebreathing valve unit is shown with connections in figure 7.



FIGURE 7. Rebreathing valve unit with connections (upper: standard RVU, lower: RVU with BBB option). 1) Gas sampling tube, 2) flowmeter, 3) respiratory bacterial/viral filter 4) mouthpiece 5) rebreathing bag 6) BBB port 7) RB port.

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2

4

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2

6

,

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5

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7

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FIGURE 7 (continued). Rebreathing valve unit with connections (RVU with optional CO2 scrubber (absorber) for LCI option). Connect the gas sampling tube to the luer-lock on the rebreathing valve unit. Make sure a small tube is connected to the insert at the RB port. Connect a rebreathing bag to the rebreathing valve unit’s RB port.

Standard Innocor

Connect a respiratory bacterial/viral filter with mouthpiece to the mouthpiece port of the rebreathing valve unit.

Innocor with BBB option

Connect the flowmeter to the mouthpiece port of the rebreathing valve unit. Connect a respiratory bacterial/viral filter with mouthpiece to the flowmeter. Connect a flow restrictor on the BBB port if the patient is unable to trigger / start a rebreathing test (only for measurements at rest).

Innocor with LCI option

Connect an optional CO2 scrubber (absorber) to the rebreathing port of the rebreathing valve unit before connecting the rebreathing bag. Make sure a small tube is connected to the insert at the RB port and guided through the centre hole of the scrubber material.



3. SYMBOLS The following symbols are used on the equipment, accessories and packaging:

Symbol Description

CAUTION

Caution, consult accompanying documents

Attention, see instructions for use

i

Consult instructions for use

On (power)

Off (power)

Mains power inlet; Input voltage ranges and fuse rating

~ Alternating current

Fuse

Universal serial bus (USB) connections

Network connection



Symbol Description

Gas outlet / inlet

Gas inlet to gas analyser

Rebreathing valve unit hose connection

Non-invasive blood pressure hose connection

Pulse oximeter probe connection

Type BF Applied Part (EN 60601-1) (protection against electrical shock)

Do not use oil or grease

CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices, with identification number of notified body

Lot number (batch code)

Serial number

LOT

SN



Symbol Description

Catalogue/Reference number

Date of manufacture (yyyy-mm / yyyy-mm-dd)

Manufacturer

Use by (yyyy-mm / yyyy-mm-dd)

Temperature limitation

180180

Keep dry

Dangerous goods label. CLASS 2 HAZARD - Gases (No. 2.2) Non-flammable, non-toxic gas. Black or white on green background.

Dangerous goods label. Class 5.1 HAZARD - Oxidizing substances (No. 5.1) Black on yellow background.

Dangerous goods label. COMPRESSED GAS

OXIDIZING, N.O.S.

(OXYGEN MIXTURE)

UN 3156, 5.1

REF



Symbol Description

Irritant.



4. ATTENTION When the ATTENTION symbol is shown on the device it means that the following safety guidelines should be followed. Additional warning and precaution statements appear in context throughout this manual:

Mains power inlet WARNING! Electrical shock hazard. Do not open the cover. Refer servicing to qualified personnel. There are no user-serviceable parts inside. The power cord should be connected only to a properly grounded AC electrical outlet.

Fuse WARNING! For continued protection against fire hazard, replace only with same type and rating of fuse.

Data interfaces Universal serial bus (USB) connections and Network connection

WARNING! The electrical interfaces on the data interface panel (USB and Network) shall not be used under normal clinical conditions within the patient zone but only during service and occasionally for data exchange. Peripheral equipment connected to these interfaces must be certified according to the respective European standards (e.g. EN 60950 for data processing equipment and EN 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard EN 60601-1-1. Everybody who connects additional equipment to the signal input part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard EN 60601-1-1. If using a version with external computer, the computer must be certified according to the European standard EN 60950. The computer should only be used on battery power. Otherwise, it is required to use a safety isolating transformer. The computer must be placed outside of the patient zone.



Excessive EMI (electromagnetic interference) may to some extent interfere with the measurements. To avoid this interference, it may be necessary to move the interfering equipment or switch to another installation group.

Gas outlet / inlet

CAUTION. Do not block or connect anything to these connectors.

CAUTION. Make sure no protective caps or plugs are fitted before bringing into use. WARNING! Fire hazard: Avoid open flames and smoking in the areas where the device is being used.

Gas cylinder and cylinder connection WARNING! Explosion hazard: Improper use, filling, storage or disposal of gas cylinder may result in personal injury, death or property damage. Gas mixture vigorously accelerates combustion. Avoid open flames and smoking in the areas where the device and gas cylinders are being used or stored. Store and use at room temperature (10-40ºC). Make sure that both the male and female gas connections are kept clean and free from oil, grease and hydrocarbons before screwing the cylinder onto the device. Use no lubricant. Use only cleaning agents that do not leave organic residues. NOTE: To reduce friction gas cylinders are supplied with a small amount of a special lubricant for oxygen service on the threaded part. Do not remove this lubricant. Aluminium high pressure gas cylinder. WARNING! Do not alter or modify the cylinder or the valve in any way. Do not use any caustic or corrosive paint or cleaners on the gas cylinder. Do not remove the product label from the gas cylinder. Use only gas cylinders provided by the manufacturer or his representative.

CAUTION. Make sure the o-ring is in place and not damaged before screwing the cylinder onto the device. To avoid damage of the o-ring seal, unscrew the cylinder in the following way:



1. Unscrew the cylinder slowly 1½ turns counter clockwise. 2. Vent the lines in the instrument to eliminate the pressure by following the steps shown on the

screen during shut-down of the application program [Exit] (or by disconnecting and eventually re-connecting the rebreathing valve unit quick connector with the application program running).

3. Then unscrew the cylinder completely. NOTE: During routine use it is recommended not to unscrew the cylinder completely and vent the gas lines when powering off (e.g. overnight). Just unscrew the cylinder 1½ turns to close the cylinder valve. To open again just turn the cylinder back on 1½ turns clockwise.

Non-invasive blood pressure hose

connection

Ensure that the air hose from Innocor to the cuff is not compressed, crimped or damaged. Ensure that the o-ring is not damaged. To connect, push on the connector until it clicks on. To disconnect, press the metal pushbutton to release the locking mechanism and pull.

Pulse oximeter probe connection WARNING! Use only pulse oximeter sensors specified by the manufacturer (see Accessories). Using other sensors may cause improper performance.

CAUTION. Inspect the sensor application site frequently to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary depending on their medical status or the condition of their skin.

CAUTION. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.

Gas inlet to gas analyser

CAUTION. Always use a particle filter provided by the manufacturer or his representative between the gas inlet connector (analyser) and the sampling tube. The filter has a male slip luer adapter on the analyser side and a female locking luer connector on the sampling tube side. Make sure the filter (membrane) is not contaminated (grey or black) inside.



Use only the Nafion dryer type of sampling tube provided by the manufacturer or his representative. Filter and tubing must be properly screwed together.

CAUTION. Make sure not to kink or otherwise damage the sampling tube. Never pull the tube.

Rebreathing valve unit hose connection Ensure that the six o-rings are not damaged. To connect, push on the connector until it clicks on (note the position of the key). To disconnect, press the coloured pushbutton to release the locking mechanism and pull.

CAUTION. Never pull the hose.

CO2 absorber cartridge The Calcium Hydroxide CO2 absorbent is classified as irritant only and can be handled (and transported by road, air and sea) as non-hazardous material.

For use only in Innocor canisters designed for the purpose. Do not use if packaging or product is damaged or has been tampered with. WARNING! Use gloves to handle or touch only plastic covered edges of the CO2 absorber cartridge. The CO2 absorbent contains caustic compounds; direct contact with unprotected skin can produce severe burns. In case of contact with skin or eyes, rinse immediately with plenty of fresh water. WARNING! CO2 absorbent is harmful if swallowed. Keep out of reach of children. Minimize time from opening to use. Do not use after expiration date. Storage temperature: -30 °C to +50 °C.



5. WARNINGS

5.1 GENERAL In case the device fails, disconnect it from the patient. Stop using the device until the problem has been solved. Contact the manufacturer or his representative if necessary.

5.2 SAFETY CLASSIFICATION

The Innocor device is classified as CLASS I Type BF equipment according to the type and degree of protection against electrical shock in accordance with EN 60601-1.

5.3 ELECTRICAL WARNING! Electrical shock hazard. Do not open the cover. Refer servicing to qualified personnel. There are no user-serviceable parts inside. The power cord should be connected only to a properly grounded AC electrical outlet. WARNING! For continued protection against fire hazard, replace only with same type and rating of fuse. WARNING! The electrical interfaces on the data interface panel (USB and Network) shall not be used under normal clinical conditions within the patient zone but only during service and occasionally for data exchange. Peripheral equipment connected to these interfaces must be certified according to the respective European standards (e.g. EN 60950 for data processing equipment and EN 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard EN 60601-1-1. Everybody who connects additional equipment to the signal input part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard EN 60601-1-1. If using a version with external computer, the computer must be certified according to the European standard EN 60950. The computer should only be used on battery power. Otherwise, it is required to use a safety isolating transformer. The computer must be placed outside of the patient zone. Excessive EMI (electromagnetic interference) may to some extent interfere with the measurements. To avoid this interference, it may be necessary to move the interfering equipment or switch to another installation group. WARNING! Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this instruction for use (see guidance and manufactures declaration attached in annex). Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.



WARNING! The use of electrical accessories with Innocor other than those specified may result in increased EMISSION (risk of disturbance of other devices) or decreased IMMUNITY (risk of disturbance of the Innocor).

5.4 ENVIRONMENTAL WARNING! Fire hazard: Avoid open flames and smoking in the areas where the device is being used. WARNING! Explosion hazard: In order to avoid an explosion risk, do not use the equipment in areas in which flammable anesthetics are applied. WARNING! Explosion hazard: Improper use, filling, storage or disposal of gas cylinder may result in personal injury, death or property damage. Gas mixture vigorously accelerates combustion. Avoid open flames and smoking in the areas where the device and gas cylinders are being used or stored. Store and use at room temperature (10-40ºC). Make sure that both the male and female gas connections are kept clean and free from oil, grease and hydrocarbons before screwing the cylinder onto the device. Use no lubricant. Use only cleaning agents that do not leave organic residues. WARNING! Do not alter or modify the cylinder or the valve in any way. Do not use any caustic or corrosive paint or cleaners on the gas cylinder. Do not remove the product label from the gas cylinder. Use only gas cylinders provided by the manufacturer or his representative. WARNING! Use gloves to handle or touch only plastic covered edges of the CO2 absorber cartridge. The CO2 absorbent contains caustic compounds; direct contact with unprotected skin can produce severe burns. In case of contact with skin or eyes, rinse immediately with plenty of fresh water. WARNING! CO2 absorbent is harmful if swallowed. Keep out of reach of children.

5.5 PROCEDURAL

WARNING! Never use the device without a new disposable single patient use bacterial/viral filter in the patient connection to minimise the risk of cross-contamination. WARNING! Use only pulse oximeter sensors specified by the manufacturer (see Accessories). Using other sensors may cause improper performance.



6. OPERATING ENVIRONMENT

Safe ambient operating temperatures range from 10 - 40 C. Humidity should not exceed 90% RH

non-condensing at 30 C. If the device has been exposed to temperatures significantly below the operating environment temperature, an acclimatisation period is necessary. Avoid excessive heat, dust and direct sunlight. For optimum performance the device must be used in a reasonably vibration-free environment because of the photoacoustic gas measurement principle. Place on a flat, horizontal and solid surface. WARNING! Fire hazard: Avoid open flames and smoking in the areas where the device is being used. WARNING! Explosion hazard: In order to avoid an explosion risk, do not use the equipment in areas in which flammable anesthetics are applied.



7. SHORT INSTRUCTIONS When all electrical and pneumatic connections are made you can switch the power on (“I”). The device is ready after a couple of minutes after being powered up.

7.1 MAIN SCREEN

The Innocor application program's main screen appears (figure 8):

FIGURE 8. Innocor main screen.

Select Measurement to perform tests or to examine data from previous tests.

Select Setup to change test, calculation or graphic settings and to perform service and calibration procedures.

Select Data Management for data exchange functions.

Select Blood Pressure to make a blood pressure measurement without rebreathing (option).

7.2 CALIBRATION It is recommended to perform all calibrations below once a day before starting the tests. It is also recommended to make a new flow calibration every time the flowmeter screen is replaced and a new flow-gas delay calibration every time the gas sample line is replaced. Select Configuration • Press Measurement on Screen. • Select the configuration: E.g. StdRVU_Ser_Scr (adults,+25kg). • Press Prepare to calibrate Innocor (only once a day).



FIGURE 9. Selection of configuration (example).

FIGURE 10. Calibration status menu.

Ambient Data Press Change ambient data and enter actual values.

Flowmeter Calibration If the Innocor contains the Breath-by-Breath or LCI Option, it is recommended to perform a gain calibration of the flowmeter once a day. It is also recommended to make a new calibration every time the flowmeter screen is replaced. • Press Calibrate flowmeter. • Connect a 1 litre or 3 litre calibrated syringe to the RVU, and set the program switch

accordingly. • Empty the syringe • Press Calibrate • Fill the syringe at a relatively low rate without “bumping” at the end. • When the program is ready empty the syringe – again at a low rate. • Repeat the filling and emptying until 2x5 strokes have been applied, and the OK button is

highlighted. • Increase the flow rate at each of the 2x5 strokes in order to try to cover the physiological test

range.



• Press OK if the new gain values are in the range 0.9 to 1.1, otherwise replace the flowmeter screen and repeat the calibration.

NOTE: • The flowmeter is automatically offset adjusted prior to each stroke. • A gas cylinder must be connected in order to close the RB port of the RB valve during the flow

calibration.

Flow-gas Delay Calibration If the Innocor contains the Breath-by-Breath or LCI Option, it is recommended to perform a calibration of the flow-gas delay once a day. It is also recommended to make a new calibration every time the gas sample line is replaced. If only the Spirometry Option is used the flow-gas delay calibration can be skipped. • Press Calibrate flow-gas delay. • Wait 1 minute for warming up. • The operator (not the subject) starts breathing in and out of the RVU. When ready the

Calibration button is pressed. Then the operator must make some slow expirations followed by very fast inspirations until the OK button is highlighted. The inspirations have to be fast in order to get a precise determination of the flow-gas delay. If one or two breaths fail the software will automatically filter these results. The delays should not vary more than 20-40 ms from day to day if the same gas sample inlet is used.

NOTE: • A gas cylinder must be connected in order to close the RB valve during the delay calibration • The BBB port on the RVU must not be connected to other devices during the delay calibration • The calibration of the flow-gas delay is critical – an error of 25 ms can give a 5% error on the

Vo2, Vco2, FRC and LCI results!

Oxygen Calibration If an oxygen sensor is included in the system it is recommended to perform a calibration of the baseline of the oxygen sensor once a day. • Press Calibrate Oxygen. • Expose gas sample line to air by removing it from breathing assembly. • Press Start to perform a one point calibration of the Oxygen. • Press OK (to Exit Prepare). • Press OK (to select configuration).



7.3 MEASUREMENT (CO BY REBREATHING / CPET PROGRAM)

7.3.1 Operating Principle

The operating principle of Inert Gas Rebreathing by Innocor is to let the patient breathe minute quantities of a blood soluble and an insoluble gas in a closed breathing assembly for a short period. The blood flowing through the lungs (effective pulmonary blood flow, PBF) absorbs the blood soluble gas. Therefore, its disappearance rate is proportional to the blood flow. Other factors affecting the distribution of the blood soluble gas are accounted for by measuring the levels of the blood insoluble gas.

7.3.2 Start of Rebreathing / CPET Program The procedure described in the following sections will under normal conditions be adequate to perform a rebreathing measurement or cardiopulmonary exercise test:

Start the program from the Innocor menu by selecting Measurement. The screen layout is as shown in figure 11.

FIGURE 11. General screen layout. 1) Patient identification field 2) date and time field 3) push button panel 4) status bar and numerical display* 5) data field for numerical results, graphics and database information etc. * Abnormal operation of pulse oximeter or probe faults is indicated by “---“ in the HR and SpO2 fields.

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7.3.3 Patient Database

Choose Patient to enter the patient database section of the program.

Press New Pt. to enter data for a new patient. Enter relevant data for the patient or test subject by pointing at the appropriate entry field and using the alphanumeric keyboard shown on the screen. Select Male or Female from the selection list or type M or

F on the keyboard to select the patient’s sex. Press Clear to clear all fields. Instead of entering new data it is also possible to search a patient already appearing in the database.

Use the Search button for this feature.

Enter one or more search criteria and press Filter to start the search process. Press All to disable all search criteria and display all patients.

Press Edit to change patient data if necessary.

After having entered or chosen the patient data, press the Select button. Results from the latest previous test are shown on the screen if available.

7.3.4 Test Preparation Check that the bottle pressure displayed in the status bar at the bottom of the screen is adequate (i.e. > 10 bar). Attach the articulated pulse oximeter (SpO2) finger clip sensor. Avoid using the same arm for BP and SpO2 measurements. See also section Pulse Oximetry. Option: Attach the BP cuff. See section Blood Pressure. Connect to the mouthpiece and attach a nose clip, or use a face mask. WARNING! Never use the device without a new disposable single patient use bacterial/viral filter in the patient connection to minimise the risk of cross-contamination.

7.3.5 Test Execution

Press Test to prepare a new measurement. Enter or verify the height and weight of the patient and enter the haemoglobin (Hb) concentration to allow calculation of derived parameters (optional).

Option: If the Innocor software is an exercise or Breath-by-Breath version, the user can select an exercise protocol, which controls the progress of the exercise level and controls a series of predefined rebreathing tests in respect to bag volume and bolus concentration.

Option: If the Innocor software contains the Spirometry version, the user can select a Spirometry test, where the user performs up to 8 forced expiration manoeuvres in order to determine the basic spirometry parameters of the subject.

If the Innocor software is a standard version without exercise or Breath-by-Breath, the Test button will start a Rebreathing test immediately. OPTION: Spirometry

Press Test and select Spirometry. The spirometry manoeuvre starts with normal tidal breathing



followed by a rapid and complete inspiration. Then immediately after the subject makes a maximal forced expiration until no more air can be expelled. Finally the subject performs a fast inspiration. It is recommended to make more than one spirometry manoeuvre in order to be sure that the measurement is representative for the subject. ATS requires at least 3 well performed spirometry manoeuvres. The

best performed manoeuvre is automatically selected and saved together with the other Innocor results.

7.3.6 Option: Breath-by-Breath The breath-by-breath calculation of gas exchange parameters starts when the exercise protocol is selected and continues until the protocol is finished - only interrupted by the rebreathings. The results of the breath-by-breath calculation are displayed on-line in a table to the left and as graphics to the right.

The content of the table can be modified using the Table Setup, and similar with the graphics, which

can be configured in 1, 2 or 3 plots using the Graph Setup. The default display is the breath-by-breath display, but the user can select other displays using the

Show results button. The Show protocol displays the progress of the exercise test, and gives the

possibility to change settings of the next steps to come if necessary. The Show results displays the

results of the previous rebreathing test, and the Show online data displays the raw flow and gas data.

A protocol can be temporary interrupted using the Hold protocol / Stop protocol.

The Innocor switches to 5 minutes cool down period, when the protocol finishes, or when the protocol

is manually terminated using the Stop protocol.

7.3.7 Rebreathing Test The device automatically prepares the rebreathing bag by emptying (using automatic detection of when the bag is empty) and filling it with the desired volume of gas. A mixture of ambient air and gas from the cylinder is filled into the bag. When the bag is ready the screen shows end-tidal gas concentrations, gas curves and the airway pressure curve.

Press Start to start the rebreathing test. Start can be pressed during any phase of the breathing cycle. The device will open to the rebreathing bag at the end of the actual expiration or at the end of the subsequent expiration following the actual inspiration. When the valve shifts the patient should hold the breath until the valve has switched completely (approx. half a second).

When breathing, try to follow the speed indicator. Breathe faster if the indicator is to the right of OK

(“Faster”). Breathe slower if the indicator is to the left of OK (“Slower”). It is essential that the rebreathing bag is being emptied completely during the first and the subsequent inspirations. The test stops automatically with empty bag when an adequate number of breaths are acquired – typical 4 or 5 breaths.

Option blood pressure (BP) measurement

It is a good idea to start a BP measurement during the bag filling (the Start NIBP button). See also section Blood Pressure. The current cuff pressure is shown in the status bar in the lower right corner of the main test window.

The BP measurement can be stopped / aborted (the Stop NIBP button) and restarted again during the rebreathing test. Only the last measured values are saved in the database.



When the BP measurement is finished the resulting Systolic / Diastolic pressures are shown for 20 s in the status bar. If the BP measurement has not finished when the rebreathing test is finished, you get a message to wait for the BP measurement. If the BP measurement is stopped the rebreathing test results will still be saved in the patient database.

7.3.8 Results

Data is being saved automatically and results are shown immediately on the screen. The display of results are organised in the following views:

Tab \ Focus Exercise test Single rebreathing test

Results

Main results of the rebreathing: Selected parameters at rest, AT and max exercise.

Main results of a rebreathing: CO, CI, Vo2/kg, SV, A-V O2 diff

Main results of a spirometry test: FVC, FEV1, FEV1%, PEF, MEF 75, MEF 50, MEF 25, FET & MVV

Details Table display of BBB parameters versus time

Detailed results of a rebreathing

Detailed results of the spirometry manoeuvres

Graphs Graphic display of BBB parameters in up to 3x3 plots

Rebreathing curves for evaluation of the quality of the test

Graphic display of the best performed spirometry manoeuvre

Data Table Table display of rebreathing and BBB results for one or more rebreathings / exercise tests

Data View 1-4 Graphic display of rebreathing and BBB results for one or more rebreathings / exercise tests Data View 5-8

The results are displayed in different ways depending on where the focus is set in the Date/Time list: a complete exercise test, a spirometry test or a single rebreathing test. The focus is set on an exercise test by selecting a line in bold with name Ex.n. or BBB.n, see below. Selecting a line named n:1, n:2 etc. will set the focus on a single rebreathing test. A spirometry test is selected by selecting a line named Spi.

FIGURE 12. Test selection panel.



Rebreathing Results:

FIGURE 13. Main rebreathing results.

FIGURE 14. Detailed rebreathing results.

Pointing inside a rebreathing plot can expand each of the four plots. See the examples below in figure 15.



FIGURE 15a. Rebreathing curves.

FIGURE 15b. Normalised soluble gas (N2O).

FIGURE 15c. Insoluble gas (SF6).



FIGURE 15d. Normalised oxygen.

FIGURE 15e. Soluble (N2O) and insoluble gas (SF6). See note (*).

FIGURE 15f. Carbon dioxide (CO2). See note (*). (*) The plot in the upper left corner of figure 15a can be configured to show one or more curves on a common y-axis. Curves are set on/off using the Graph Setup button.



Breath-by-Breath results

With focus on an exercise test and the Results tab activated will display selected BBB parameters at Rest, AT (Anaerobic Threshold) and at Max exercise level:

FIGURE 16. Main exercise results (example of setup).

Pressing the Details tab will display selected BBB parameters in a table. The time step can be configured to 30, 60, 90, 120 seconds or every breath.

FIGURE 17. Detailed exercise results (example of setup).

Pointing on the Breath-by-Breath plots (Graphs) will expand the plots. A second press on a plot will expand the actual plot.



FIGURE 18. 3x3 plots of Breath-by-Breath results.

Spirometry results

With focus on a spirometry test and the Results tab activated gives a numerical display of the spirometry results:

FIGURE 19. Spirometry main results.



Pressing the Details tab will display the results of the individual spirometry manoeuvres.

FIGURE 20. Spirometry details results.

Pressing the Graphs tab will display the graphic result of the best performed spirometry manoeuvre.

FIGURE 21. Spirometry graphic results.

Pointing on the spirometry plots (Graphs) will enter the detailed display of the individual spirometry manoeuvres.

Common results

Press the Data Table Tab to display the results in a tabular form for the selected tests. The Table

Setup can be used to configure the contents of the table. The table can be printed directly using the

Print Table.



FIGURE 22. Data Table.

Pressing the Data View Tabs will display the results in XY plots for the selected tests. The data view

can be configured via the Dataview Setup. Both the X-axis and the Y-axis can be defined with respect to what to display, grid and min/max on axes. Up to 5 parameters can be selected on the y-axis. Each parameter can be assigned to the left or right y-axis, and a 1st or 2nd order regression line can be fitted to the data.

FIGURE 23. Data View.

7.3.9 After a Test Press one of the following buttons:

Test to repeat a test on the same patient (allow sufficient time for washout of inert gases).

Print Prev. to preview and print results.

Patient to enter the patient database for entering or searching patient data.

Pt. Data to change patient data (Hb, Height, Weight).



Test Param. to change settings for the rebreathing manoeuvre.

Demo to perform a trial rebreathing test using air (dry run).

Exit Meas. to exit to the Innocor main screen (menu).

7.3.10 Setup

From the Innocor main screen (menu), use the Setup button to change test settings (or press the Test

Param. button from a test result screen).

Change settings for the rebreathing test from the main Setup screen. It is recommended to use the

factory default settings. As a guideline use a Bolus fraction on 10%.

Choose Ambient from the Setup screen to change ambient data (pressure, temperature and humidity).

Choose User Params to define up to 5 user defined parameters (numbers). The name of the user parameters are limited to standard characters [a..z,A..Z,0..9,_]. A user parameter is deleted by deleting the name of the parameter. User parameters are manual entered before or after a test.

Choose Language from the Setup screen to select the language.

Option: Choose Protocol Setup to define one or more protocols. A protocol is defined as a series of rebreathing tests at different exercise levels on a bicycle ergometer or a treadmill. For each step the exercise level, time interval, bag volume, bolus and breathing frequency shall be defined as a fixed or auto value. An auto value calculates automatically the value during the execution of the protocol.

Choose Gas Cylinder from the Setup screen to enter the Gas Cylinder identification menu. Use this

menu to mount a new gas cylinder to the Innocor, or when changing gas cylinders.

Calibration

Choose Adjust O2 for calibration of the oxygen sensor (option). Follow the instructions on the screen. It is recommended to perform a one-point calibration using air (20.95% O2) once every month.

Option: Choose Adjust Flowmeter for a calibration of the flowmeter. It is recommended to perform the calibration every day.

Option: Choose Calculate gas delay for a calibration of the delay between the gas signal and the flow signal. It is recommended to perform the calibration every day. Gas calibration will normally not be necessary because of the stability of the analyser and the fact that only relative changes are determined in the rebreathing method.

Press Close from the Setup screen to go back to the Innocor main screen (menu).

7.3.11 Data Exchange

For data exchange, press the Data management button in the Innocor main menu.

7.3.12 Blood Pressure Test (Stand-Alone)

Option: For access to a stand-alone blood pressure program press Blood Pressure. Set the initial pressure and press start to initiate the measurement. See also section Blood Pressure.



7.3.13 Recommended Settings At rest it is recommended to use a rebreathing frequency of 20-30 /min. During exercise it is recommended to use a larger rebreathing bag volume of 2 - 2.5 litre and a rebreathing frequency of 30 /min, resulting in a ventilation of at least 60 l/min. Allow sufficient time for washout of inert gases between repeated tests on the same patient. At rest 5 minutes is generally adequate. During exercise 2 minutes is recommended. Select a bolus fraction of e.g. 10 % of the bag volume (can be set to 7.5 - 50 % of the bag volume). However, ensure that the bolus volume is big enough to prevent a situation with deficiency of oxygen in the inspired air, in particular when testing during exercise.

7.3.14 Termination of Program

Remember to unscrew the gas cylinder (as a minimum 1½ turns) before you exit the Innocor application. When turning the gas cylinder 1½ turns counter-clockwise the main valve of the gas cylinder is closed.



7.4 MEASUREMENT (LCI BY MULTIPLE-BREATH WASH-OUT)

7.4.1 Operating Principle

Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas: Inert gas rebreathing (IGR) is used for rapid wash-in of a very small amount of SF6 until an even concentration is obtained in the lungs before the wash-out can start. During rebreathing the patient inhales an oxygen enriched mixture from a pre-filled rubber bag. This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCE) required to clear the SF6 from the lungs. The wash-out phase is initiated by automatically disconnecting from the bag at the end of an inspiration where after the patient breathes room air until the end-tidal SF6 concentration has fallen below the predetermined fraction of 1/40th of the starting concentration. See figure 24.

FIGURE 24. The SF6 concentration measured during wash-in by rebreathing followed by wash-out in open-circuit breath-by-breath mode.

7.4.2 Start of LCI Program After a successful calibration the following procedure (7.4.3 to 7.4.10) will under normal conditions be adequate to perform a measurement:

Start a test from the Innocor menu by selecting Measurement.

7.4.3 Patient Selection

Select a patient in the patient database or press New Pt. to enter data for a new patient.

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reliable FRC determination

Washout to 1/40 of

starting concentration



Enter relevant data for the patient or test subject by pointing at the appropriate entry field and using the alphanumeric keyboard shown on the screen. Select Male or Female from the selection list or type M or

F on the keyboard to select the patient’s sex. Press Clear to clear all fields.

It is possible to search a patient already appearing in the database. Use the Search button for this purpose.

Enter one or more search criteria and press Search to start the search process. Press Show All to disable all search criteria and display all patients.

Press Edit to change patient data if necessary.

After having entered or chosen the patient data, press the Select button.

7.4.4 General Screen Layout The general screen layout is shown in figure 25.

FIGURE 25. General screen layout. 1) Patient identification field, 2) data field for numerical results, 3) date and time field, 4) list of performed tests, 5) push button panel, 6) data field for graphic results, 7) status field for Gas bottle pressure, heart rate and oxygen saturation*, and 8) test comments field. * Abnormal operation of pulse oximeter or probe faults is indicated by “---“ in the HR and SpO2 fields. Results from the most recent test are shown on the screen if available.

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7.4.5 Test Preparation Check that the bottle pressure displayed in the status bar at the bottom of the screen is adequate (i.e. > 10 bar). Attach the articulated pulse oximeter (SpO2) finger clip sensor. See also section Pulse Oximetry. Connect to the mouthpiece or face mask and attach a nose clip. WARNING! Never use the device without a new disposable single patient use bacterial/viral filter in the patient connection to minimise the risk of cross-contamination.

Press Test Param. to edit the setup.

FIGURE 26. Setup menu. It is recommended to use the factory default settings.



Parameter Default Comments

O2 limit 13% The wash-in is stopped if the O2 gets lower than the O2 limit.

CO2 limit 10% The wash-in is stopped if the CO2 gets higher than the CO2 limit.

Bolus fraction 20% Fraction of the bag volume coming from the gas bottle. A higher bolus fraction gives a higher O2 concentration in the bag.

FRC mixing threshold 15% Threshold to find the location of the breaths used for the FRC calculation.

LCI mixing threshold 2% Threshold to determine the stop of the wash-in.

Bag volume – VT ratio 1.5 Ratio to determine the bag volume based on the VT.

FRC breaths after mixing 3 Number of breaths used to calculate the FRC.

Trigger signal O2 Trigger signal to find the expirations (O2 or CO2).

FRC calculation on insoluble Average Method to fit the FRC line. Reg. line or Average.

Bag dead space 13 ml Dead space of the bag when empty.

Valve dead space 103 ml Dead space of valve in rebreathing / wash-in mode.

FRC skip at start exp. 30% Part of expiration not used in the calculations – at the start.

FRC skip at end exp. 15% Part of expiration not used in the calculations – at the end.

7.4.6 Test Execution The LCI test contains 3 phases:

Preparation, where the subject’s resting tidal breathing is measured and used to prepare the correct amount of rebreathing volume.

Wash-in, where the subject is rebreathing in the bag until the insoluble tracer gas is mixed with the lungs.

Washout, where the subject is breathing in normal air until the insoluble tracer gas is washed out of the lungs.



Preparation:

Press Test to prepare a new measurement. The subject shall breathe quietly. The CO2 scrubber cartridge is designed for approx. 20 tests and should be replaced when either the inspired or expired CO2 concentration exceeds certain limits, e.g. FICO2 > 2.5 % or FETCO2 > 6.5 % (see section 8.6 and 11.3). The material is non-indicating.

With the subject breathing quietly the operator can press the Prepare Bag. The device automatically prepares the rebreathing bag by emptying (and automatically detecting when the bag is empty) and filling it with the desired volume of gas. A mixture of ambient air and gas from the cylinder is filled into the bag.

FIGURE 27. LCI preparation.

Numerical display

Configuration of numerical display

Volume versus time with averaged VT

Configuration of graphical display

VT and Freq versus time



Wash-in:

When the bag is ready the Start Wash-in button is highlighted. If the subject is still breathing quietly the

operator presses the Start Wash-in. Start Wash-in can be pressed during any phase of the breathing cycle. The device will open to the rebreathing bag at the end of the actual expiration or at the end of the subsequent expiration following the actual inspiration. The subject is still breathing quietly, and when the insoluble gas is mixed well between the bag and the lungs, the device will close to the rebreathing bag at the end of the next expiration, and the washout period is started. The wash-in takes typically one minute for a subject with healthy lungs.

FIGURE 28. Wash-in. If down going spikes are detected on the insoluble curve during wash-in a leak is present and has to be located and corrected before the start of washout. A leak will not destroy the wash-in, but will affect the washout and thereby the results (FRC and LCI). NOTE: It is difficult to see a leak during washout.

Wash-in mixing status

Insoluble gas during wash-in



Washout:

The subject continues to breathe quietly, and when the insoluble gas is washed out of the lungs, the test is completed. The wash-out takes typically 2 minutes for a subject with healthy lungs. When 2 or more LCI manoeuvres have FRC’s within 10% they are marked online with a √. The operator can stop the LCI test when 2 or more manoeuvres are marked with a √ - otherwise continue up to max. 5 manoeuvres.

FIGURE 29. Washout. If the patient coughs during the washout the manoeuvre can not be used and an extra manoeuvre must be collected. After the test the operator must manually change the mode to not be used – see below.

Accepted tests: FRC within 10%

Online predicted FRC and LCI

Washout time and no. of breaths

Insoluble gas during washout

Washout status



7.4.7 Results

Data is being saved automatically and results are shown immediately on the screen. The display of Multiple Breath Washout (MBW) results are organised in the following views:

Tab \ Focus Display

Results Main results of the MBW: Averaged LCI & FRC.

Details Main results of the MBW: Averaged LCI & FRC, as well as detailed LCI & FRC for each manoeuvre.

Graphs N/A

Data Table Table display of LCI & FRC results for one or more MBW tests

Data View 1-4 Graphic display of LCI & FRC results for one or more MBW tests

Data View 5-8

The Results are displayed for the test in focus in the Date/Time list (see figure 30).

FIGURE 30. LCI results. Pointing inside a plot gives an expanded view of each of the plots.

Washout of insoluble gas versus FRC turnovers

Numerical results Date & time of LCI tests



FIGURE 31. Detailed results (expanded view). Innocor selects as default the best LCI manoeuvres by looking at the manoeuvres with FRC’s within 10%. It first takes the manoeuvres with accepted status, i.e. the manoeuvres where the wash-in mixing is below 2%. If no one is accepted, it takes the manoeuvres with FRC’s within 10% of all manoeuvres. The main LCI results are the average of the “used” LCI’s and FRC’s. If the patient coughs during the washout – the manoeuvre shall not be used – and the operator shall remove the “√” under used – see below. Pressing the tab 1, 2, 3 … will bring up detailed graphs for the individual manoeuvres – see figure 32. The displays can be user configured to show:

- raw curves, - wash-in of insoluble gas, - washout of insoluble gas and - turnover plot.

“Iwi” displayed in the upper left windows is the wash-in index at the end. To be accepted the number must be below 2%.

Manoeuvres used in main results?

Main LCI results

Status of each wash-in



FIGURE 32. Results for a single manoeuvre. Pressing Setup will bring up the menu for configuration of the graphic.

FIGURE 33. Setup menu for graphs. Pressing the Details tab on the measurement screen – see figure 34 – will bring up numerical results of each manoeuvre behind the test as well as the averaged result.



FIGURE 34. LCI numerical results. Press the Data Table tab to display the results in a tabular form for the selected tests, and thereby compare results of different days. The Table Setup can be used to configure the contents of the table. The table can be printed directly using the Report. Pressing the Data View tabs will display the results in XY plots for the selected tests. The data view can be configured via the Dataview Setup. Both the X-axis and the Y-axis can be defined with respect to what to display, grid and min/max on axes. Up to 5 parameters can be selected on the y-axis. Each parameter can be assigned to the left or right y-axis, and a 1st or 2nd order regression line can be fitted to the data.

7.4.8 After a Test Press one of the following buttons:

Test to repeat a test on the same patient. A new test can be started immediately after the previous – also if the previous has been interrupted.

Report to print results.

Delete to delete a test.

Exit Meas. to exit to the Innocor main screen (menu).

7.4.9 Setup

From the Innocor main screen (menu), use the Setup button to change test settings.

Choose Ambient from the Setup screen to change ambient data (pressure, temperature and humidity).

Press Misc to change system settings.

Choose Gas Cylinder to enter the Gas Cylinder identification menu. Use this menu to mount a new gas

cylinder on Innocor, or when changing gas cylinders.

Choose User Params to define up to 5 user defined parameters (numbers). The name of the user parameters are limited to standard characters [a..z,A..Z,0..9,_]. A user parameter is deleted by deleting the name of the parameter. User parameters are manual entered before or after a test.



Choose Date to set the time and date and to change formats.

Choose Language to select the language.

Choose Units to set the units used by Innocor.

7.4.10 Calibration

Choose Calibration - Adjust O2 for calibration of the oxygen sensor. Follow the instructions on the screen. It is recommended to perform a one-point calibration using air (20.95% O2) once every day.

Choose Calibration - Adjust Flowmeter for calibration of the flowmeter. It is recommended to perform the calibration every day.

Choose Calibration - Calculate gas delay for a calibration of the delay between the gas signal and the

flow signal. This is not necessary for the LCI measurement, but it can be a good check of the Innocor device with respect to gas sample flow. The flow-gas delays are typically between 1,200 and 1,400 ms. Gas calibration will normally not be necessary because of the stability of the analyzer and the fact that only relative changes are determined in the LCI method.

Press Exit Setup from the Setup screen to go back to the Innocor main screen (menu).

7.4.11 Data Exchange For data exchange, press the Data management button in the Innocor main menu. Insert an empty USB memory stick in the Innocor – see figure 3.

Press Script found

Find and select the script: Copy Data to USB.idm

Press Perform Move the USB memory stick to a standard computer. Locate the actual test files in the folder USB:\LCI named as LCIEnnnnmmm-ddmmyyyy-hhmm.LCI, where

Ennnnmmm is the patient ID ddmmyyyy is the date of the test hhmm is the time of the test

7.4.12 Recommended Settings The setup menu is shown in figure 35.



FIGURE 35. Setup menu. It is recommended to use the factory default settings.

Parameter Default Comments

Bag volume – VT ratio 1.5 Ratio to determine the bag volume based on the VT.

Bolus fraction 20% Fraction of the bag volume coming from the gas bottle. A higher bolus fraction gives a higher O2 concentration in the bag.

O2 limit 10% The wash-in is stopped if the O2 gets lower than the O2 limit.

CO2 limit 10% The wash-in is stopped if the CO2 gets higher than the CO2 limit.

Scrubber type Serial

7.4.13 Termination of Program

Remember to unscrew the gas cylinder (as a minimum 1½ turns) before you exit the Innocor application. When turning the gas cylinder 1½ turns counter-clockwise the main valve of the gas cylinder is closed.



8. RVU DESCRIPTION

8.1 OPERATING PRINCIPLE

The Innocor RVU is a low resistance respiratory valve unit with a high level of hygiene due to a disposable valve insert. The RVU controls the breathing path of the subject to either breathing air or gas from the rebreathing bag. The subject is connected to the RVU via a bacterial filter to avoid contamination of the valve insert.

The RVU is connected to the Innocor via a 6-tube containing tubes for controlling the pneumatic valves, bag filling and evacuation, and a tube for measuring the mouth piece pressure. A rebreathing bag is connected to the lower port of the RVU at the back. If the subject has very low ventilation and is not able to trigger a start of a rebreathing test a flow restrictor can be inserted at the lower port of the RVU at the front.

FIGURE 36. Respiratory Valve Unit (RVU) with rebreathing bag, bacterial filter and mouth piece.

6-tube Rebreathing bag

Bacterial filter Respiratory Valve Unit

Ambient air port with flow restrictor

Rebreathing bag port

Connection to Innocor

Mouth piece



8.2 VALVE INSERT

CAUTION. The valve insert is not intended to be used sterilised / disinfected. Do not clean. The

valve insert is intended to be replaced when changing the Innocor gas bottle, which corresponds to approx. 75 tests depending on use. The disposable valve insert is made of silicone, and is placed inside a plastic housing, which is easy

to dissemble and assemble. Remember to power off the Innocor or enter the main menu of the

Innocor software before changing the valve insert – otherwise the gas bottle will be emptied. When done rotate the knob with the Innovision logo clockwise and the plastic housing becomes loose and can be taken apart. The old valve insert is removed and a new valve insert is fit on the metal plate inside the plastic housing. Put the other part of the plastic housing on top and press the two parts gently together until a click is heard. The RVU is now ready to use.

FIGURE 37. Assembly of RVU. The valve insert is mounted with a small fitting and a short tube to the bag filling / evacuation port inside the rebreathing bag port. This must not be removed; otherwise the mixing of the bolus and air gas will not be adequate.

Knob

Valve insert Plastic housing

Plastic housing

6-tube


Ambient air port with flow restrictor

Bacterial filter port



FIGURE 38. Valve insert

8.3 FLOW RESTRICTOR The flow restrictor, which can be used if the ventilation is too low to trigger the start of a rebreathing, contains 4 small membrane flaps.

FIGURE 39. Flow restrictor

Flow restrictor


Ambient air port

Rebreathing bag connector

Tube

Fitting

Bag filling / evacuation port



8.4 RVU TEST The RVU operates via pneumatic gas and is designed to open to either the rebreathing bag port at the back or to the ambient air port at the front. The RVU valve can be tested using the service part

of the Innocor software:

Disconnect the rebreathing bag and flow restrictor

Enter Setup

Enter Service

Press the Misc TAB

Press the Valve TAB

Press the Pneu 1 button, and check that the rebreathing bag port is closed

Press the Pneu 2 button, and check that the ambient air port is closed

8.5 SPIROMETRY MODE Option: When running a spirometry test the flowmeter must be set in stand alone mode, where the inspiration / expiration flow only enters the flowmeter and bacterial filter in order to minimize the flow resistance. The flowmeter and holder are disconnected from the RVU, moved upwards and reconnected using the knob on the lower part of the holder.

FIGURE 40. Flowmeter in spirometry mode

CAUTION. Flowmeter must be removed from RVU port to stand-alone position for spirometry test.



8.6 LCI MODE / CO2 SCRUBBER Option: For LCI testing a CO2 scrubber (absorber) can be mounted in the rebreathing port (see figure 7, last picture) to avoid build-up of CO2 during the rebreathing period where the inert tracer gas is washed in. The absorber material is a Calcium Hydroxide mixture with the trade name ExtendAir® CO2 Absorbent. The absorbent material, which uses the same chemistry as a granular sodalime absorbent, is a microporous polyethylene sheet coiled to form a cartridge. The molded ribs in the material create channels through which the breathing gases flow (see figure 41). One of the unique features of an ExtendAir® cartridge is that the breathing resistance of the absorbent is precisely controlled by the constant rib height and spacing, resulting in a uniform reaction zone within the absorbent. Also, dusting is avoided.

FIGURE 41. CO2 scrubber (cartridge and canister parts).



9. PULSE OXIMETRY

9.1 OPERATING PRINCIPLE Oxygen saturation SpO2, expressed as a percentage, defines the amount of oxygen carried compared to total capacity. It is measured by a two-wavelength pulse oximeter. The SpO2 value is measured by a light absorption technique: Red and infrared light (660 nm and 910 nm) is emitted from the emitter side of the sensor. The light is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detected in the detector side of the sensor. When the pulsative part of the light signal is examined, the amount of light absorbed by arterial haemoglobins is discovered and the saturation level can be calculated. The pulse oximeter equipment is calibrated to display functional oxygen saturation.

No SpO2 Alarms.

9.2 ATTACHING THE SENSOR

Connect the sensor to the SpO2 connection on the Innocor patient interface (right side) panel. Remove finger nail polish, artificial nails etc. from the measuring site first. Insert a finger (preferably the index, middle or ring finger) into the articulated finger clip sensor (see figure 42) until the end of the finger reaches the finger stop. Keep the fingernail facing the sensor top (as shown in the figure). Ensure that long fingernails do not interfere with proper finger position. For the best results when using the sensor for data collection, secure the sensor cable independently from the sensor with medical tape, preferably around the base of the finger. Make sure that the tape securing the cable does not restrict the blood flow. The thumb is not recommended for use with the articulated finger clip sensor. NOTE: Proper sensor placement is critical for good performance. If the sensor is not positioned properly, light may bypass the tissue and result in SpO2 inaccuracies. Do not pull the sensor from its cable.

FIGURE 42. Correct finger position in pulse oximeter articulated finger clip sensor.



9.3 ACCURACY Factors that may degrade pulse oximeter performance include the following:

excessive ambient light

excessive motion

electrosurgical interference

arterial catheters, blood pressure cuffs, infusion lines, etc.

moisture in the sensor

improperly applied sensor

carboxyhaemoglobin

methaemoglobin

residue (e.g., dried blood, dirt, grease, oil) in the light path

artificial nails

incorrect sensor type

poor pulse quality

venous pulsations

anaemia or low haemoglobin concentrations

cardiovascular dyes

sensor not at heart level

dysfunctional haemoglobin

fingernail polish A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or probe.

9.4 PRECAUTIONS FOR USE WARNING! Use only pulse oximeter sensors specified by the manufacturer (see Accessories). Using other sensors may cause improper performance. Refer to the Instructions for Use supplied with the pulse oximeter sensor. Pulse oximeters are not able to distinguish between HbCO, MetHb and HbO2. The saturation values may be somewhat higher for smokers. Special care should be taken with patients who have burns or carbon monoxide (CO) intoxication. When carbon monoxide intoxication is suspected, always confirm the pulse oximetry reading with a blood sample measurement. Intravascular dyes may cause erroneous readings. For example, methylene blue, indigo carmine, indocyanine green or any substances that contain dyes, interfere with the SpO2 measurement.

CAUTION. Inspect the sensor application site frequently to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary depending on their medical status or the condition of their skin.

CAUTION. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.

9.5 CONTRAINDICATIONS

The pulse oximeter is contraindicated for use in the presence of Magnetic Resonance Imaging (MRI) devices.



10. BLOOD PRESSURE

10.1 OPERATING PRINCIPLE The non-invasive blood pressure (NIBP) measurement is an option, which may not be installed in your device.

It consists of an oscillometric NIBP module with a pressure transducer inside Innocor, a quick coupling on the side panel, a patient cable (air hose) and an arm cuff. The pressure transducer converts the cuff pressure to an analog output voltage, and also detects the small oscillometric waveforms resulting from the patient's arterial pulses. The oscillometric waveform is passed through a filter network (rejecting artifact and other noise) while being amplified. After digitisation of the oscillometric signal the signal is further filtered (using software filtering techniques) before being used by the main algorithm to determine the systolic and diastolic points in the waveform. Simultaneously, the cuff pressure is measured directly from the transducer output. By combining the information provided by the oscillometric waveform and the cuff pressure, the systolic and diastolic blood pressures are determined. Analysis of the oscillometric waveform also provides information on the pulse rate.

10.2 PERFORMANCE Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff / stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers. The performance with common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation, has been verified by use of a patient simulator.

10.3 POSITIONING THE CUFF The operating steps that are important for correct application are described below and include the selection of a suitable cuff size and correct positioning of the cuff. It is important to select the cuff size that is appropriate to the diameter of the patient's upper arm. There are markings on the cuff indicating the limb circumference for which it is appropriate. Use the Range Lines on the inside of the cuff to determine the correct size cuff to use. There is a marking of the centre of the bladder, indicating the correct position for the cuff over the artery. Wrap the cuff around the arm making sure that the Artery Marker is aligned over the brachial artery as shown in figure 43.

Ensure that the air hose from Innocor to the cuff is not compressed, crimped or damaged. Please remember that using a cuff that is the wrong size may give false and misleading results.



FIGURE 43. Correct position of NIBP cuff with Artery Marker aligned over brachial artery.

10.4 PRECAUTIONS FOR USE Refer to the Instructions for Use supplied with the cuff. To obtain accurate blood pressure readings, the cuff must be the correct size, and also be correctly fitted to the patient. Incorrect size or incorrect fitting may result in incorrect readings. Refer to figure 43 above. Blood pressure readings may also be affected by the position of the subject, and his/her physiologic condition, and other factors. The NIBP option may not operate correctly if used or stored outside the relevant temperature and humidity ranges. The nominal range for the result of the blood pressure measurement is: Pressure: 25 to 260 mmHg Pulse rate: 40 to 200 BPM



11. CLEANING AND MAINTENANCE

This chapter is a short guide to maintenance of the Innocor device. It includes recommendations regarding cleaning and general maintenance and replacement of accessories and disposable parts. Procedures for periodical checks are dealt with in the next chapter. Should the equipment show signs of malfunction, do not use it. Call the manufacturer or distributor for assistance. It is recommended that the equipment be serviced every 12 months by a service technician authorised by the manufacturer.

11.1 REPLACEMENT OF GAS ANALYSER FILTERS

A 0.5 m hydrophobic particle filter must always be fitted to the gas inlet on the patient interface panel before the sampling tube is mounted. The particle filter must be changed if it gets dirty or wet inside. The necessary frequency of replacement depends very much on the use and the environment. Weekly or even daily replacement may be required. Replace the filter if you observe a slow dynamic response of the gas analyser or if the filter becomes grey or black inside.

11.2 REPLACEMENT OF GAS ANALYSER SAMPLING TUBE The sampling tube should be replaced if it is damaged in order to make sure that there are no leaks. Never try to repair a damaged tube with adhesive tape or similar. The drying performance of the tube is maintained over long periods. It is recommended to replace the tube every half year or more frequently.

11.3 REPLACEMENT OF RESPIRATORY PARTS Replace the silicone valve insert after approx. 75 tests corresponding to the contents of a gas bottle. Option: Replace the flowmeter screen when dirty or when the flowmeter calibration gain is outside the range 0.9 to 1.1. Option: For replacing the CO2 scrubber for LCI testing, simply open the canister and place the ExtendAir® cartridge into the canister (see figure 41). Then make sure the O-ring is in place in the groove in the lower part and press the two canister parts together. The CO2 scrubber cartridge is designed for approx. 20 tests and should be replaced when either the inspired or expired CO2 concentration exceeds certain limits, e.g. FICO2 > 2.5 % or FETCO2 > 6.5 %.

11.4 CLEANING AND REPLACEMENT OF DUST FILTER FOR COOLING FAN The dust filter to the right of the patient interface panel should be checked on a regular basis and be replaced or cleaned e.g. once a month, depending on use. Remove the filter by unscrewing the two screws holding the filter cover and pulling out the material with fingers.



Shake or blow out the dust (from inside out). Let the filter soak in a mild detergent solution (see 11.6.1). Rinse the filter and let dry before attaching back to the fan. If the filter material is damaged or can not be cleaned replace it with a new one.

11.5 CALIBRATIONS

11.5.1 Gas Analyser Calibration The photoacoustic gas analyser (measuring the inert soluble and insoluble gases N2O and SF6 plus CO2) does not need regular calibration. A periodic calibration check or gain calibration should be performed by the manufacturer or his representative e.g. once every year using a special calibration gas mixture and a side-stream connection to protect against damage from over-pressure. In the unlikely event that major deviations from the expected readings are found the device must be returned to the manufacturer for multi-point calibration.

11.5.2 Oxygen Sensor Calibration

The oxygen sensor (optional) can be calibrated by means of the Adjust O2 function under Setup. The frequency of calibration of the oxygen sensor depends on various factors. A monthly check or calibration is recommended. Use ambient air for the regular one-point calibration. No tools are necessary to make the adjustment. Follow the instructions on the screen. Allow sufficient time for warm-up prior to starting the calibration (minimum 15 minutes recommended) to ensure that the sensor meets full specifications. A periodic two-point calibration check or two-point calibration should be performed by the manufacturer or his representative e.g. once every year using pure oxygen and air and a side-stream connection to protect against damage from over-pressure.

11.5.3 Airway Pressure Sensor Calibration The airway pressure sensor is factory calibrated and does not need re-calibration. The airway pressure zero point is calibrated automatically as part of the bag preparation before each rebreathing test.

11.5.4 Rebreathing Gas Filling Flow Calibrations The rebreathing gas bolus filling flow rate and the air filling flow rate should be verified by the manufacturer or his representative on a yearly basis. Repeated filling and emptying procedures are performed and a calibrated syringe is used for emptying the bag. NOTE: The filling volumes and flow rates are in litre/min ATPD.

11.5.5 Gas Cylinder Pressure Sensor Calibration The high-pressure sensor is factory calibrated and does not need re-calibration. However, the offset (zero-point) may easily be adjusted by using the Service program if the pressure is non-zero with the gas cylinder disconnected. The adjustment requires no tools.

11.5.6 Pulse Oximeter Calibration The manufacturer should check the performance of the pulse oximeter, e.g. once a year, using a special calibration kit.

11.5.7 Non-Invasive Blood Pressure Calibration The calibration of the optional NIBP pressure transducer should be verified on a yearly interval or every 10,000 readings, which ever comes first. The manufacturer or his representative should perform this verification using an accurate reference transducer and a vessel (reservoir).



11.5.8 Flowmeter Sensor Calibration

The flowmeter sensor (optional) can be calibrated using the Calibration – Adjust Flowmeter under Setup. It is recommended to make the calibration every day, and when the flowmeter screen has been changed.

11.5.9 Flow-gas delay Calibration

The delay between the flow signal (optional) and the gas signal can be calibrated using the Calibration

– Calculate gas delay under Setup. It is recommended to make the calibration every day, and when the inlet tube has been changed.

11.6 CLEANING

11.6.1 General Never clean the equipment when powered. Always unplug the electric power cord before cleaning. Do not use sharp instruments during cleaning. Do not use abrasive cleaning agents. When a mild detergent solution is recommended for cleaning below, use a liquid containing 5-30 % ionic surfactants such as sodium laureth sulfate or sodium lauryl ether sulfate, with neutral pH (6-8 range), and preferably free of fragrances and dyes. Avoid oxidising agents such as sodium hypochlorite and peroxides.

11.6.2 Casing Surfaces and parts in general should be cleaned with a slightly damp cloth. Care should be taken to prevent liquids from entering the equipment – in particular through the cooling air exhaust holes on the rear cover. Any liquids on the equipment should be removed with a dry cloth immediately. In most cases cleaning with a mild detergent solution is sufficient (see 11.6.1). For disinfection of the device use a non-aggressive solution (e.g. 70% alcohol plus 0.5% chlorhexidine in water).

11.6.3 LCD / Touch Screen Display Wipe the LCD / touch screen display after use with a cloth moisturised with a mild detergent solution (see 11.6.1) or glass cleaner.

11.6.4 Cleaning and Maintenance of RVU

General

The RVU is classified as a reusable device with a replaceable valve insert.

The RVU insert is supplied clean, non sterile.

The RVU is protected by patient specific breathing filter and will not come into contact with mucous membranes.

The RVU insert can be used for up to 100 rebreathing tests before disposal.



Cleaning

The cleaning of reusable devices usually begins soon after use. Remove filter and mouthpiece from RVU. Wiping the RVU with a mild detergent solution is sufficient cleaning. The disposable valve insert is not intended to be sterilized, disinfected or cleaned.

Drying

Prevent the growth of waterborne organisms, the valve insert and bag should be thoroughly dried prior to storage. Dry thoroughly using a soft cloth (preferably sterile) or disposable paper towels.

Inspection All components should be visually inspected for cleanliness, proper function and freedom of defects.

Storage

Confirm that the valve is completely dry prior to storage. Valves should be stored in a way that prevents recontamination or damage between uses. New valve insert is supplied clean in heat sealed plastic bags. Store patient specific mouthpiece and filter separately from the RVU.

11.6.5 Cleaning of Respiratory Parts Respiratory parts can be disassembled and cleaned using warm or hot water and a mild detergent solution if necessary. The exterior of hoses is also cleaned using water and a mild detergent solution if necessary. The latex free rebreathing bag is reusable. Follow the Instructions for Use from the manufacturer for cleaning and sterilisation. The bacterial/viral filter used in the patient connection is for single-patient use only – DO NOT REUSE OR CLEAN. Follow the Instructions for Use from the manufacturer.

The mouthpieces and facemasks used with the Innocor are reusable. Follow the Instructions for Use from the manufacturer for cleaning and disinfection/sterilisation.

The nose clips used with the Innocor are disposable. Follow the Instructions for Use from the manufacturer.

11.6.6 Cleaning of Gas Analyser Sampling Tube The Nafion gas sampling tube is reusable and only needs cleaning when hygiene demands or when performance is affected. Rinsing with a hydrophobic solvent such as hexane may be used to clean the Nafion gas dryer tubing. Alternately, rinsing with 10% nitric acid, followed by rinsing with de-ionised water and drying can be used. De-ionised water alone can also be used for cleaning. Do not autoclave or clean using aqueous salt solutions. Drying is accomplished by passing a dry gas through the tube for up to 20 minutes depending on the dry gas flow rate.



CAUTION. Long-term exposure to water or to acid may cause damage to the dryer fittings due to swelling of the Nafion (25% when exposed to liquid water). Be careful not to kink or break the Nafion tubing during the cleaning process.

11.6.7 Cleaning of Pulse Oximetry Sensor

Detach the sensor from the patient and Innocor.

CAUTION. Do not autoclave or immerse the sensor in liquid of any kind. Do not sterilise with EtO. Do not use caustic or abrasive cleaning agents on the sensors. Refer to the Instructions for Use supplied with the pulse oximeter sensor for cleaning.

11.6.8 Cleaning of NIBP Cuff (Option) Refer to the Instructions for Use supplied with the cuff for cleaning.

11.6.9 External Computer For versions using an external computer, refer to the cleaning instructions supplied by the computer manufacturer.



12. PERIODICAL CHECKS To ensure the safety and functionality of the device, you the below checks and tests should be performed as a minimum once a year and each time service has been performed.

12.1 INSPECTION Perform the below inspection: 1. Are all markings and labels on the device correct and legible? 2. Are all parts of the device firmly secured (no loose items)? 3. Is the enclosure of the device undamaged? 4. Are the accessories undamaged? 5. Are all connectors undamaged? 6. Are the device and its accessories clean? 7. Do the switches operate correctly? 8. Is the main fuse of the correct type as marked on the device? 9. Are the Instructions for Use complete?

12.2 PERFORMANCE CHECK It is recommended that a performance test is made at regular intervals (e.g. every year). Main test parameters are gas analyser signal-to-noise ratios, pneumatic function of the rebreathing valve, and bag filling volumes (bolus and air volumes). It is recommended that the performance of the optional NIBP sensor is checked on a yearly interval or every 10,000 readings, which ever comes first, and after maintenance and repair to ensure that the device operates properly and safely at all times. See also the section on Calibrations.

12.3 SAFETY CHECK Electrical safety tests should be performed according to EN 60601-1. Should any of the safety tests fail due to damaged accessories, replace the accessories. Should any of the safety tests fail, do not use the equipment until the problem has been solved. In the following are the main items of the test:



12.3.1. Dielectric strength No flashover may occur when performed:

1. Between mains part and conductive chassis parts Test voltage 1.5 kV, 50 Hz 2. Between phase and neutral in mains inlet Fuses must be removed! Test voltage 1.5 kV, 50 Hz 3. Between patient parts and conductive chassis parts Test voltage 1.5 kV, 50 Hz

12.3.2. Earth leakage current (Tested under normal and single fault conditions, normal and reversed polarity). Maximum allowed current - normal condition: 0.5 mA Maximum allowed current - single fault condition: 1.0 mA

12.3.3. Enclosure leakage current (Tested under normal and single fault conditions, normal and reversed polarity). Maximum allowed current - normal condition: 0.1 mA Maximum allowed current - single fault condition: 0.5 mA

12.3.4. Protective earthing of the device.

Maximum allowed resistance: 0.2 (with supply cord)

Maximum allowed resistance: 0.1 (without supply cord)

13. DISASSEMBLY AND DISPOSAL

13.1 DISASSEMBLY PROCEDURE In general, disassembly is the reverse of the installation procedure.

To remove the gas cylinder from Innocor do as follows: Stay in the application program. Unscrew the cylinder slowly 1½ turns counter clockwise. Vent the lines in the instrument to eliminate the pressure by following the steps shown on the screen during shut-down of the application program [Exit] (or by disconnecting and eventually re-connecting the rebreathing valve unit quick connector with the application program running in Measurement mode). Then unscrew the cylinder completely. NOTE: During routine use it is recommended not to unscrew the cylinder completely and vent the gas lines when powering off (e.g. overnight). Just unscrew the cylinder 1½ turns to close the cylinder valve. When the application program shuts down you will be prompted to switch off the device on the main power switch (“0”).



13.2 DISPOSAL OF DEVICE AND ACCESSORIES If you want to discard the device, do so in a way that will not harm the environment and according to national law. Please contact your national authorities for details on where and how to discard the equipment. Keep the original packaging for use in the event that the equipment needs to be returned for repair or servicing.



14. SPECIFICATIONS

Mechanical Size: ........................................................................................ 35 x 29 x 26 cm (W x H x D) Weight: ................................................................................ 8-9 kg (depending on options)

Electrical Power supply: ..................................................................................... 200-240 V, 50/60 Hz .............................................................................................................. 100-120 V, 50/60 Hz Power consumption: ..................................................................... 45 W nom., 100 W max. Fuse requirements: ...................................................................................... 2 x 1A T/250V Protection: ........................................................... Class I type BF according to EN 60601-1

Environmental

Operating temperature: ...................................................................................... 10 – 40 C Operating pressure: ...................................................................................525 – 800 mmHg

Operating humidity: ............................................. 10 - 90 % RH, non-condensing @ 30 C

Warm-up time: ................................................. 10 minutes from room temperature (20 C) Storage temperature: ..................................................................................... -20 to +50º C Humidity: ...................................................................................... 0 to 90 % (not condensed)

Display Type: ............................................................................................... Colour TFT LCD display Size: ............................................................................................................................. 12.1" Resolution: ....................................................................................... SVGA (800x600 pixels) Touch screen: ......................................................................... High-resolution resistive type Only valid for devices with integrated computer.

Integrated computer Processor: ........................................ 586 class 300 MHz Pentium MMX or 1 GHz Celeron RAM: ....................................................................................................................... >128 MB Harddisk: ................................................................................................................. >16 GB Operating system: ......................................................................... Windows XP Embedded Only valid for devices with integrated computer.

Electrical interfaces Devices with integrated computer: Networking: ................................................................................ PCI 10/100 Mbps Ethernet PC interfaces: .................................................................. 2 x Universal Serial Bus (USB A) Devices with external computer: PC interfaces: 2 x Universal Serial Bus (USB A) 1 x Universal Serial Bus (USB B)



Rebreathing valve Valve insert ................................................................................. Silicone, Elastosil R 420/40 Pneumatic operation pressure ......................................................................... 0.3 to 0.6 bar Rebreathing bag / ambient air port inside diameter ................................................... 30 mm Bacterial filter port inside diameter ............................................................................. 34 mm Flow resistance without bacterial filter and flow restrictor ....................... 1.5 cm H2o @ 5 l/s Disposable bacterial/viral filter for single patient use CO2 scrubber ............................................... ExtendAir® Calcium Hydroxide CO2 absorbent

Gas supply Gas composition: ........................................................................ 5% N2O, 1% SF6, 94% O2

Cylinder capacity: ...................................................................... 18 liters (0.15 l @ 124 bar) Typical number of tests using automatic dilution with air: ................................................. 75

Parameters CO Cardiac output CI Cardiac index * SV Stroke volume SI Stroke index * PBF Pulmonary blood flow VL Lung volume (or FRC, Functional Residual Capacity) HR Heart rate SpO2 Arterial oxygen saturation SvO2 Mixed venous oxygen saturation ** A-V O2 diff Arterial – mixed venous oxygen saturation ** VO2 Oxygen uptake ** VO2/kg Oxygen uptake per kg * ** VO2/BSA Oxygen uptake per kg (oxygen consumption index) * ** Intrapulmonary shunt Intrapulmonary shunt fraction ** SYS Systolic blood pressure ** DIA Diastolic blood pressure ** MAP Mean arterial blood pressure ** SVR Systemic vascular resistance ** SVRI Systemic vascular resistance index ** Hb Hemoglobin concentration * BSA Body surface area *



Breath-by-Breath gas exchange parameters: VO2 Oxygen uptake VO2/kg Oxygen uptake per kg * VO2/BSA Oxygen uptake per kg (oxygen consumption index) * VCO2 Carbon dioxide excretion R Respiratory exchange ratio Ve Expiratory minute ventilation Va Alveolar ventilation Vd Anatomical dead space Vt Tidal volume Resp.Freq. Respiratory rate FO2et End-tidal concentration of oxygen FCO2et End-tidal concentration of carbon dioxide FIO2 Inspired oxygen concentration FICO2 Inspired carbon dioxide concentration Ve/VO2 Expiratory quotient / ventilatory equivalent for oxygen Ve/VCO2 Expiratory quotient / ventilatory equivalent for carbon dioxide HR Heart rate SpO2 Arterial oxygen saturation Load Exercise level on bicycle ergometer Speed Running speed on treadmill or Pedal speed on bicycle ergometer Slope Slope on treadmill The following parameters can be calculated after an incremental exercise test: AT Anaerobic threshold (measured by V-slope***) RC Respiratory compensation (measured by V-slope***) Rest and max values of all Breath-by-Breath parameters.

* Requires manual input. ** Requires optional sensors. *** Beaver WL, Wassermann K, Whipp BJ (1986) “A new method for detecting anaerobic

threshold by gas exchange” J Appl Physiol 60:2020-2027 Spirometry parameters: FEV1 Forced expiratory volume in 1 second FVC Forced vital capacity FEV1% FEV1/FVC PEF Peak expiratory flow MEF 75 Maximal instantaneous forced expiratory flow where 75% of the FVC remains

to be expired MEF 50 Maximal instantaneous forced expiratory flow where 50% of the FVC remains

to be expired MEF 25 Maximal instantaneous forced expiratory flow where 25% of the FVC remains

to be expired FET Forced expiratory time MVV Maximum voluntary ventilation (calculated as 40 • FEV1) LCI parameters: LCI Lung Clearance Index FRC Functional Residual Capacity



Gas analyser Principle: ............................................................ Photoacoustic Spectroscopy Components and ranges: .................... N2O 0-2.5%, SF6 0-0.5%, CO2 0-10%

Accuracy: .................................................................................... 1% relative Signal-to-noise ratio: ............................... > 1000 @ half-scale (N2O and SF6) ................................................................................ > 400 @ half-scale (CO2) Sampling frequency: ............................................................................ 100 Hz Sample flow rate: ........................................................................... 120 ml/min Rise time (10-90%): .......................................................................... < 200 ms Calibration check interval: .............................................................. 12 months

Oxygen sensor

Principle: ............................................... Laser diode absorption spectroscopy Measuring range: ................................................................................. 5-100%

Accuracy: .................................................................................... 1% relative Signal-to-noise ratio: ............................................................. > 500 @ 21% O2 Sampling frequency: ............................................................................ 100 Hz Sampling flow rate: ........................................................................ 120 ml/min Rise time (10-90%): .......................................................................... < 170 ms Calibration check interval (2-point): ................................................ 12 months Calibration (check interval) (1-point): ..................................................... 1 day

Flowmeter Principle: ......................................................................... Differential pressure Measuring range: ................................................................................... ±15 l/s

Flow accuracy: .......................................................... 2% relative or 20 ml/s

Volume accuracy: ........................................................ 3% relative or 50 ml Sampling frequency: ............................................................................ 100 Hz Lowpass filter: ........................................................................................ 18 Hz Response time (10-90%) ...................................................................... < 30 ms Offset calibration interval: ......................................................................... auto Gain calibration interval: ......................................................................... 1 day

Pulse oximeter Oxygen Saturation Range: ...............................................................0 to 100% Pulse Rate (HR) Range: ..................................... 40 to 240 pulses per minute Measurement Wavelengths*: ....................... Red - 660 nm @ 3 mW nominal .................................................................. Infrared - 910 nm @ 3 mW nominal SpO2 accuracy (± 1 SD*): .............................. 70 - 100% ± 2 digits (for adults) ................................................................................ Below 70% is not specified Rate accuracy: ........................................................................... ± 3% ± 1 digit Data update period (SpO2 and HR): ................................................ 1 s (online) ...................................................... 1 average value for test (Rebreathing, LCI) ................................................. 1 average value per breath (Breath-by-breath) Patient Isolation: .......................................................................... > 12 M Ohm Leakage Current: ...................................................................... Not applicable The pulse oximeter is designed to use Nonin sensors only. SD (Standard Deviation) is a statistical measure: Up to 32% of the readings may fall outside these limits. * Information about wavelength range can be especially useful to clinicians.



Non-invasive Blood Pressure (NIBP) Method of Measurement: ........................................................... Oscillometric ................................ Diastolic values correspond to Phase 5 Korotkoff sounds Blood Pressure Range: - Systolic: .................................................................. 40 mmHg to 260 mmHg - Diastolic: ................................................................. 20 mmHg to 200 mmHg Heart Rate Range: ............................ 40 BPM to 200 BPM (Beats Per Minute) Transducer Accuracy: ............. ± 3 mmHg between 0 mmHg and 300 mmHg Calibration check interval: ....................... 12 month or every 10,000 readings

Certification/Safety standards 93/42/EEC ................................................................. Medical Device Directive EN 60601-1 .................................................. General Requirements for Safety EN 60601-1-1 ................. Safety Requirements for Medical Electrical Systems EN 60601-1-2 ..................................................... Electromagnetic compatibility EN ISO 9919 .................................. Pulse oximeters - Particular requirements EN 1060-3 .............................................. Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems INNOVISION reserves the right to change specifications without notice.



15. ACCESSORIES Only the following accessories should be used with the equipment. All accessories are available from INNOVISION.

GENERAL Filter, Fan FIL00002 Fuse, 5x20, 1A T FUS00001

GAS ANALYSER Nafion Dryer Gas Tube 70” TUB00101 Particle filter, Millex 13mm FIL00001

BREATHING ASSEMBLIES Nose Clip, Hans Rudolph: CLI00002 Standard bag Rebreathing Bag, 3L Latex Free: BAG00001 Rebreathing Bag, 4L Latex Free: BAG00002 Rebreathing Bag, 6L Latex: BAG00003 Rebreathing Bag, 5L Latex Free: BAG00004 Rebreathing Bag, 1L Latex Free: BAG00007 Rebreathing Bag, 2L Latex Free: BAG00008 Rebreathing Bag, ½L Latex Free: BAG00009 Bacterial Filter, Pall PF-30S: FIL00101 HYGROBABY CO2 port 8M/15M-15F: FIL00102 HYGROBOY ISO 22M/15F-22F/15M: FIL00103 Barrierbaby - Electrost. Filt.: FIL00104 Barrierbac S - Electros. Filt.: FIL00105 Mouthpiece Size M Hans Rudolph: MOU00003 Mouthpiece Size S Hans Rudolph: MOU00004 Mouthpiece Size M Saliva, HR: MOU00005 Standard Hans Rudolph facemask Facemask Adult, Small: FCM00001 Facemask Adult, Medium: FCM00002 Facemask Adult, Large: FCM00003 Facemask Child, Large: FCM00004 Facemask Child, Small: FCM00005 Adaptors for Hans Rudolph facemasks HR Face mask IF – Adult: MEC00151 HR Face mask IF – Pediatric: MEC00157

Hans Rudolph headcap for facemask Headcap, Small: FCM00101 Headcap, Large: FCM00102 Flowmeter screen: FIL00200



Silicone valve insert SUB00042 CO2 scrubber cartridge ABS00001

GASES Rebreathing test set TESTSET Silicone valve insert and rebreathing test gas Rebreathing test gas, excl. cylinder GAS00001 Supplied by INNOVISION only (or their representative)

5% N2O, 1% SF6, 94% O2 Cylinder capacity: 18 liters (0.15 l @ 124 bar) O-Ring, CGA-170 Core Valve ORI00009

PULSE OXIMETRY Finger Clip Sensor, 2m SEN00010

CALIBRATION Syringe, 1-litre SYR00001 Syringe, 3-litre SYR00002 Tube for syringe 1-1/8"x36" TUB00301

Annex A Guidance and manufacturer’s declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

The Innocor is intended for use in the electromagnetic environment specified below. The customer

or the user of the Innocor should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1

The Innocor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class A The Innocor is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable

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Guidance and manufacturer’s declaration – electromagnetic immunity (1/2)

he Innocor is intended for use in the electromagnetic environment specified below. The customer or

the user of the Innocor 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

±6 kV contact ±8 kV air

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

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

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

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 interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

<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 sec

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

Innocor requires continued operation during power mains interruptions, it is recommended

that the Innocor be powered from an uninterruptible power supply.

Power frequency (50/60 Hz) magnetic field 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 (2/2)

The Innocor is intended for use in the electromagnetic environment specified below. The customer or

the user of the Innocor should assure that it is used in such an environment.

Immunity test IEC 60601

test level

Compliance

level Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz

3 Vrms 3 V/m

Portable and mobile RF communications equipment should be used no closer to any part

of the Innocor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=1.2 √P 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 power 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 deter-mined by an electromagnetic site survey, a should be less than the compliance level in each 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 in 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 Innocor is used exceeds the applicable

RF compliance level above, the Innocor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting

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

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Recommended separation distance between portable and mobile RF communications

equipment and the Innocor

The Innocor is intended for use in the electromagnetic environment in which radiated RF disturbances

are controlled. The customer or the user of the Innocor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the Innocor as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

Separation distance according to frequency of transmitter

m

W 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 din meters (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 watt (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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innocor instructions for use - innovision 11.5.8 flowmeter sensor ... or any other penetration...

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