Inncor Instructions for Use Rev 07 June 2021

Innocor® Instructions for Use

COSMED Nordic ApS

TABLE OF CONTENTS ABOUT THIS MANUAL ... 1 1. INTRODUCTION TO INNOCOR ... 1 1.1 DEVICE DESCRIPTION ... 1 1.1.1 Inert Gas Rebreathing (Cardiac Output Measurement) ... 3 1.1.2 Breath-by-Breath Gas Exchange (VO2 Measurement) ... 4 1.1.3 Spirometry (Measurement of Lung Volumes and Flows) ... 4 1.1.4 Multiple-Breath Wash-Out (LCI Measurement) ... 4 1.2 INTENDED USE ... 5 1.3 INTENDED APPLICATIONS AND PATIENT POPULATION ... 7 1.4 INTENDED OPERATORS AND ENVIRONMENT ... 7 1.5 CONTRAINDICATIONS ... 7 1.6 ADVERSE EVENTS/REACTIONS ... 7 1.7 WARRANTY AND EXPECTED SERVICE LIFE ... 7 1.8 DISCLAIMER... 8 2. PRODUCT OVERVIEW AND INSTALLATION ... 9 3. SYMBOLS ...16 4. ATTENTION ...20 5. WARNINGS ...25 5.1 GENERAL ... 25 5.2 SAFETY CLASSIFICATION ... 25 5.3 ELECTRICAL ... 25 5.4 ENVIRONMENTAL ... 26 5.5 PROCEDURAL ... 27 5.6 Patient Data ... 27 6. OPERATING ENVIRONMENT ...28 7. SHORT INSTRUCTIONS ...29 7.1 MAIN SCREEN ... 29 7.2 DAILY INSPECTION ... 30 7.3 CALIBRATION... 30 7.4 MEASUREMENT (CO BY REBREATHING / CPET PROGRAM) ... 33 7.4.1 Operating Principle... 33 7.4.2 Start of Rebreathing / CPET Program ... 33 7.4.3 Patient Database ... 34 7.4.4 Test Preparation... 34 7.4.5 Test Execution ... 34 7.4.6 Option: Breath-by-Breath ... 35 7.4.7 Rebreathing Test ... 35 7.4.8 Results ... 36 7.4.9 After a Test ... 42 7.4.10 Setup ... 43 7.4.11 Data Exchange... 43 7.4.12 Blood Pressure Test (Stand-Alone) ... 43 7.4.13 Recommended Settings ... 44 7.4.14 Termination of Program ... 44 7.5 MEASUREMENT (LCI BY MULTIPLE-BREATH WASH-OUT) ... 45 7.5.1 Operating Principle... 45

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7.5.2 Start of LCI Program ... 45 7.5.3 Patient Selection ... 45 7.5.4 General Screen Layout ... 46 7.5.5 Test Preparation... 47 7.5.6 Test Execution ... 48 7.5.7 Results ... 52 7.5.8 After a Test ... 55 7.5.9 Setup ... 55 7.5.10 Calibration ... 56 7.5.11 Data Exchange... 56 7.5.12 Recommended Settings ... 56 7.5.13 Termination of Program ... 57 8. RVU DESCRIPTION ...58 8.1 OPERATING PRINCIPLE ... 58 8.2 VALVE INSERT... 59 8.3 FLOW RESTRICTOR ... 61 8.4 RVU TEST ... 61 8.5 SPIROMETRY MODE ... 61 8.6 LCI MODE / DISPOSABLE SCRUBBER (CO 2 ABSORBER) ... 62 9. PULSE OXIMETRY...63 9.1 OPERATING PRINCIPLE ... 63 9.2 ATTACHING THE SENSOR ... 63 9.3 ACCURACY ... 64 9.4 PRECAUTIONS FOR USE ... 64 9.5 CONTRAINDICATIONS ... 65 10. BLOOD PRESSURE ...66 10.1 OPERATING PRINCIPLE ... 66 10.2 PERFORMANCE ... 66 10.3 POSITIONING THE CUFF ... 66 10.4 PRECAUTIONS FOR USE ... 67 11. CLEANING AND MAINTENANCE ...68 11.1 CLEANING ... 68 11.1.1 General ... 68 11.1.2 Casing ... 68 11.1.3 Cleaning and Maintenance of RVUs ... 68 11.1.4 Cleaning of Flowmeters (Pneumotachs)... 69 11.1.5 Cleaning of Respiratory Parts ... 69 11.1.6 Cleaning of Gas Analyser Sampling Tube ... 70 11.1.7 Cleaning of Pulse Oximetry Sensor ... 70 11.1.8 Cleaning of NIBP Cuff (Option) ... 70 11.1.9 External Computer ... 70 11.2 INFECTION CONTROL RECOMMENDATIONS ... 70 11.3 CLEANING AND REPLACEMENT OF DUST FILTER FOR COOLING FAN ... 72 11.4 REPLACEMENT OF GAS ANALYSER FILTERS ... 72 11.5 REPLACEMENT OF GAS ANALYSER SAMPLING TUBE... 72 11.6 REPLACEMENT OF FUSE ... 73

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11.7 REPLACEMENT OF RESPIRATORY PARTS ... 73 11.8 CALIBRATIONS... 73 11.8.1 Gas Analyser Calibration ... 73 11.8.2 Oxygen Sensor Calibration ... 73 11.8.3 Airway Pressure Sensor Calibration ... 74 11.8.4 Rebreathing Gas Filling Flow Calibrations ... 74 11.8.5 Gas Cylinder Pressure Sensor Calibration ... 74 11.8.6 Pulse Oximeter Calibration ... 74 11.8.7 Non-Invasive Blood Pressure Calibration ... 74 11.8.8 Flowmeter Sensor Calibration ... 74 11.8.9 Flow-gas delay Calibration ... 74 12. PERIODICAL CHECKS ...75 12.1 INSPECTION ... 75 12.2 PERFORMANCE CHECK ... 75 12.3 SAFETY CHECK ... 75 13. DISASSEMBLY AND DISPOSAL ...77 13.1 DISASSEMBLY PROCEDURE ... 77 13.2 DISPOSAL OF DEVICE AND ACCESSORIES ... 77 14. SPECIFICATIONS ...78 15. ACCESSORIES ...82

Annex A Guidance and manufacturer’s declaration

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ABOUT THIS MANUAL 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. WARNING! A 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.

CAUTION A precaution statement 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 model you are using.

1. INTRODUCTION TO INNOCOR 1.1 DEVICE DESCRIPTION Innocor is a non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters. Innocor utilizes a non-invasive, inert gas rebreathing technique to measure • • •

Cardiac Output Pulmonary Blood Flow Lung volume

Innocor incorporates a prefilled breathing bag with an oxygen-enriched mixture containing known quantities of two foreign gases. When a patient breathes the mixture, Innocor’s photoacoustic gas analyser technology measures the relative levels of the foreign gases over about 10-20 seconds and calculates these three parameters from those measurements. Innocor also measures or calculates other hemodynamic parameters non-invasively based on pulse oximetry. These include: • • •

Pulse rate Arterial oxygen saturation Stroke volume

With the non-invasive blood pressure (NIBP) Option installed, Innocor also measures or calculates other hemodynamic parameters. These include: • •

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Blood pressures (Systolic, Diastolic and Mean Arterial Blood Pressure) Systemic vascular resistance

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In addition, with certain parameters of the patient manually entered by the operator, Innocor calculates these hemodynamic parameters: • • •

Cardiac index Stroke index Systemic vascular resistance index

The Breath-by-Breath (BBB) Option for cardiopulmonary exercise testing (CPET) provides measurements of gas exchange parameters including: • • • • • • • • • • • •

Oxygen uptake Carbon dioxide excretion Respiratory exchange ratio Ventilation Tidal volume Respiratory rate End-tidal gas concentrations Ventilatory equivalents for O 2 and CO 2 Alveolar ventilation Anatomical dead space Anaerobic threshold Respiratory compensation point

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 the following parameters: • • • • • • • • •

Forced expiratory volume in 1 second (FEV 1) Forced vital capacity (FVC) FEV1/FVC (FEV 1%) Peak expiratory flow (PEF) Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired (MEF 75) Maximal instantaneous forced expiratory flow where 50% of the FVC remains to be expired (MEF 50) Maximal instantaneous forced expiratory flow where 25% of the FVC remains to be expired (MEF 25) Forced expiratory time (FET) Maximum voluntary ventilation (MVV), calculated as 40 × FEV1

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 minimize the flow resistance. This gives the opportunity to determine whether the patient’s exercise intolerance is caused by ventilatory limitation or by a limitation in the cardiovascular system. The specific parameters measured by the Innocor LCI Option include:

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• •

Lung Clearance Index (LCI) Functional Residual Capacity (FRC)

These parameters are determined by measurements of the respiratory flow and SF 6 concentration in a combined inert gas rebreathing manoeuvre for wash-in of tracer gas and a multiple-breath washout test with the patient breathing ambient air.

1.1.1 Inert Gas Rebreathing (Cardiac Output Measurement) Cardiac output (CO) is defined as the volume of blood pumped by the heart per unit of time (blood flow in litres per minute). The measurement with Innocor is non-invasive (i.e., it does not necessitate catheterization or any other penetration through a body orifice or the body surface) because inert gas rebreathing is a pulmonary gas exchange method. 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 (approximately 15 seconds). The blood flowing through the lungs (effective pulmonary blood flow, or PBF) absorbs the blood soluble gas; therefore, the disappearance rate is proportional to the blood flow. The blood insoluble gas is also measured to determine the lung volume from which the soluble gas disappears and to account for other factors that affect distribution of the blood soluble gas. A patient able to breathe spontaneously and capable of following directions is told by the person administering the test (Operator) to put on a nose clip and then to breathe into a respiratory valve (using a mouthpiece with a bacterial/viral filter). At the end of an expiration the Operator activates the valve so that the patient will breathe in and out (rebreathe) exclusively from a rubber bag for a period of approximately 15 seconds. The patient is asked to empty the rebreathing 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 (O 2) 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. Oxygen is measured by means of a laser diode absorption spectrometer. N2O is soluble in blood and is, therefore, absorbed during the blood’s passage of the lungs at a rate that is directly proportional to the blood flow through the lungs. Accordingly, the higher the cardiac output the higher the disappearance rate of N2O (slope of measured gas curve). SF6, on the other hand, is insoluble in blood and, therefore, it stays in the gas phase in the lungs. It is used to determine the lung volume from which the soluble gas is removed by the blood. CAUTION: The Cardiac Output may be subject to error in the presence of a significant pulmonary shunt. Use the pulse oximeter to determine whether there may be the possibility of significant shunting (SpO2 ≤ 95 % while breathing room air). 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. The pulse oximeter component of Innocor measures heart rate (HR) and arterial oxygen saturation (SpO2) during the test. HR enables a calculation of stroke volume (SV) etc., and SpO 2 indicates whether the patient’s oxygenation is normal, or if there is a significant intrapulmonary shunt (SpO 2 < 95%) in which case pulmonary blood flow is not an accurate measure of cardiac output. An oscillometric non-invasive blood pressure (BP) measuring system is also included as an option.

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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.

1.1.2 Breath-by-Breath Gas Exchange (VO2 Measurement) The Breath-by-Breath (BBB) Option provides measurements of metabolic gas exchange parameters 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 principle in the determination of the oxygen uptake and the carbon dioxide excretion is to estimate the difference between airway influx and efflux of oxygen and carbon dioxide during inspiration and expiration. This is done by integrating the product of oxygen or carbon dioxide concentration and flow in the respiratory gas over an interval, which covers a complete respiratory cycle. The results are corrected partly for changes in oxygen and carbon dioxide contents of the lungs by using equations based on the change in functional residual capacity (FRC) from one breath to the next and by assuming constant end-tidal concentrations of O2 and CO2 from breath to breath. The expiratory minute ventilation is estimated by simply integrating the flow over a whole expiration and dividing by the length of the breath. This is also the case for the alveolar ventilation except that the product of anatomical dead space and respiratory rate is subtracted. The anatomical dead space is determined from the capnogram (CO2 curve) and the flow signal. The respiratory rate, the tidal volume and the time of inspiration are determined from the flow signal alone. The end-tidal concentrations are determined as the minimum/maximum concentrations of oxygen/carbon dioxide at the end of expiration. The respiratory and expiratory quotients are found as the ratio between carbon dioxide excretion and oxygen uptake, and as the ratio between expiratory minute ventilation and oxygen uptake or carbon dioxide excretion, respectively.

1.1.3 Spirometry (Measurement of Lung Volumes and Flows) The Spirometry Option provides measurements of the lung function in terms of flows and volumes determined during a forced breathing manoeuvre consisting of tidal breathing followed by a full inspiration and 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 minimize the flow resistance. The flow signal is integrated to determine volumes. The manoeuvre and the calculations follow standardized criteria and equations.

1.1.4 Multiple-Breath Wash-Out (LCI Measurement) The LCI is calculated as the cumulative expired volume (V CE) required to clear the tracer gas from the lungs during normal breathing, minus the product of the number of wash-out breaths and the external dead space outside the lips, divided by the subject’s Functional Residual Capacity (FRC). FRC is the amount of air that stays in the lungs (up to the lips) after a normal expiration. In other words, LCI represents the number of lung volume turnovers (i.e. FRCs) that the subject must breathe to clear the tracer gas from the lungs (by convention, to an end-tidal concentration of 1/40th of the starting concentration over three subsequent breaths).

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Innocor uses sulphur hexafluoride (SF6) as the tracer gas. SF6 is an inert, non-toxic gas. The measurement is performed using a sensitive and fast responding photoacoustic infrared gas analyser and a flowmeter (pneumotachometer) is used to record the inspiratory and expiratory flows at the mouth. The patient is breathing through a mouthpiece or a face mask connected to the flowmeter via a bacterial filter, and a gas sampling tube is connected to the breathing assembly for sidestream gas analysis. 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. When both steps are finished the LCI is calculated as the ratio between VCE and FRC. Guidelines on lung function testing recommend that the MBW test be repeated to obtain at least two tests in which the difference between two FRC values is less than 10% when comparing the higher to the lower FRC value. The combination of inert gas rebreathing and multiple breath wash-out – the QuickTest™ Option offers several advantages compared to conventional wash-in/wash-out. Inert gas rebreathing is a more effective manoeuvre to obtain good mixing of the gases compared to multiple breath wash-in. This means significantly shorter test time and significantly reduced consumption of test gas. In combination with Innocor’s sensitive SF6 analyser and the dilution of the test gas mixture with air this means drastically reduced consumption of SF6.

1.2 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

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(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 (SpO 2 < 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 FEV 1 (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 SF 6 concentration are measured during tidal breathing. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer). The SF 6 concentration is measured by means of a photoacoustic infrared analyser. An oxygen enriched rebreathing gas mixture for washin of SF6 is automatically filled into a rubber bag prior to testing by adding a bolus of mixture to air.

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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 operating system. However, knowledge of Windows is not required to operate the device. The device is operated either via a simple touch screen interface or using mouse/touchscreen.

1.3 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, rehabilitation, hypertension, pulmonary hypertension, haemodialysis 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 can understand the instructions from the operator and performing the manoeuvre well.

1.4 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 or web-based video conference training is typically offered by the manufacturer or its representative during installation. Innocor is intended for a professional use environment (hospitals, clinics) and not for home-care environments.

1.5 CONTRAINDICATIONS The Innocor is contraindicated to measure Cardiac Output in patients with a significant pulmonary shunt. A significant shunt may be present if the arterial oxygen saturation, while breathing room air, is low (SpO2 ≤95% as measured by the Innocor’s pulse oximeter), in which case cardiac output is underestimated.

1.6 ADVERSE EVENTS/REACTIONS None known.

1.7 WARRANTY AND EXPECTED SERVICE LIFE Innocor is covered by a warranty on parts and workmanship in accordance with the Conditions of Sale. This warranty excludes limited lifetime parts and consumable parts. The expected service life for this device is 10 years. This may be extended conditional on availability of parts and components.

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1.8 DISCLAIMER COSMED Nordic ApS (the manufacturer) considers itself responsible for effects on safety, reliability and performance of this equipment only if: •

Persons authorized 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.

•

Calibrations are conducted as prescribed by the manufacturer.

The device contains no internal user-serviceable components. In the event of failure or defect, contact the manufacturer or his representative.

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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 figures 1 and 2. Depending on the configuration of the device it may look different from what is shown in this and the following figures.

FIGURE 1. Front view of Innocor Innocor is operated via an external computer under Windows. The external computer may be a tablet (shown), a laptop or a stationary PC.

The operator and data interfaces of Innocor is shown in figure 2. Depending on the configuration of the device it may look different from what is shown in this and the following figures.

1

2

1

3 4

2

1) Patient Interface Panel 2) Cooling Air Inlet

1) 2) 3) 4) 5)

5

Lifting Slot Cooling Air Outlet Gas Cylinder Connection Power Interface Panel Data Interface Panel

FIGURE 2. Left) Right side view, Right) Rear view. The rear panel to the left is the power interface panel (figure 3) for the mains AC power input.

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FIGURE 3. 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 4).

FIGURE 4. Data interface panel equipped with a USB connector cord. The USB type A connector terminal (not shown) of the cord is connected to the external PC.

Connect the computer using the USB connector cord on the Data interface panel to the right. Connect the USB type A end of the cable to the computer. WARNING! If using a version with external computer, the computer must either be medical grade (IEC 60601-1 certified) or alternatively be certified according to the IEC 60950-1 standard for IT equipment and be placed outside of the patient zone.

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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 2 right, no. 3), ensure that an intact O-ring is in place (figure 5). Connect the gas cylinder to the fitting (figure 6) 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 5. Gas cylinder connection, position (left) and cross-sectional view (right). Note correct positioning of O-ring seal (right).

FIGURE 6. Innocor with gas cylinder mounted and RVU (standard type) in storage position.

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The right side panel is the patient interface panel (figure 7).

FIGURE 7. 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 Luer-Slip adapter on the analyser side and a female Luer-Lock 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 (RVU, standard and compact variants respectively), is shown with connections in figure 8 and 9. The standard RVU may be used for adults at peak exercise, the compact RVU has smaller dead spaces and is the better choice for children and adults at rest.

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1

3 ,

4 ,

6 , 7 ,

5 ,

2

1

7 ,

3 ,

4 ,

6 , 5 ,

FIGURE 8. Rebreathing valve unit with connections. Standard RVU without and with BBB/LCI 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

3

1

4 6 7 8 5

FIGURE 9. Rebreathing valve unit with connections. Upper: Standard RVU with LCI option. Lower: Compact RVU. 1) Gas sampling tube, 2) flowmeter, 3) respiratory bacterial/viral filter, 4) mouthpiece, 5) rebreathing bag, 6) BBB port, 7) RB port, 8) disposable scrubber (CO2 absorber) for LCI option.

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Innocor® Instructions for Use

COSMED Nordic ApS

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 Disposable Scrubber (CO2 absorber) to the rebreathing port of the rebreathing valve unit. On the standard RVU, connect via a black adapter 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. The scrubber is mounted directly on the compact RVU.

2021-06

MAN-0001 Rev. 07 /EN

15

Innocor® Instructions for Use

COSMED Nordic ApS

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)

100-120V~ 200-240V~

Mains power inlet; Input voltage ranges and fuse rating

T 1A H 250V

~

Alternating current

Fuse

Universal serial bus (USB) connections

Gas outlet / inlet

2021-06

MAN-0001 Rev. 07 /EN

16