Inncor Software User Manual Issue A Rev 7 March 2007

Innovision

Innocor™ Software User Manual

TABLE OF CONTENTS 1 1.1 1.2 1.2.1 1.2.2 1.2.3 1.3 1.4 1.5 1.6

INTRODUCTION AND APPLICABILITY OF THIS MANUAL ... 1 APPLICABILITY OF THIS MANUAL ... 1 INTRODUCTION TO INNOCOR ... 1 Intended use ... 1 Intended applications and patient population ... 2 Intended operators and environment... 2 INNOCOR MODELS... 3 SUMMARY OF REVISION CHANGES ... 3 SOFTWARE CHANGES... 3 INNOCOR SYMBOLS... 4

2 SOFTWARE DESCRIPTION... 5 2.1 ENTERING PATIENT DATA ... 5 2.2 MAKING A SINGLE MEASUREMENT ... 7 2.3 PROTOCOL / EXERCISE EXECUTION ... 10 2.3.1 Starting a protocol... 10 2.3.2 Running a protocol... 12 2.3.2.1 Protocol screen ... 12 2.3.2.1.1 Changing protocol parameters on-line... 13 2.3.2.1.2 Protocol estimation ... 14 2.3.2.1.3 Bag preparation ... 17 2.3.2.2 Result screen ... 19 2.3.3 Breath-by-Breath on-line screen... 20 2.3.4 On-line raw data screen... 21 2.3.5 Cool down period ... 22 2.4 EVALUATING RESULTS ... 22 2.4.1 Exercise test results... 23 2.4.2 Exercise test details ... 23 2.4.3 Exercise test graphs ... 24 2.4.3.1 AT and RC detection... 26 2.4.3.2 Deleting Breath-by-Breath results... 27 2.4.3.3 Breath-by-Breath graph setup ... 28 2.4.4 Rebreathing results... 28 2.4.5 Rebreathing details ... 29 2.4.6 Rebreathing graphics... 29 2.4.6.1 Normal plot... 30 2.4.6.2 Normalised Oxygen ... 32 2.4.6.3 Normalised soluble gas (N2O) ... 33 2.4.6.4 Insoluble gas (SF6) ... 33 2.4.7 Data Table ... 34 2.4.7.1 Calculated parameters... 35 2.4.8 Data View... 36 2.4.9 Patient data... 38 2.4.10 Prints ... 39 2.5 SETUP ... 42 2.5.1 Test Parameters ... 42 2.5.2 Hidden Manoeuvre / Calculation Parameters ... 45 2.5.2.1 Manoeuvre parameters... 46 2.5.2.2 Calculation parameters ... 47 2.5.2.3 Breath-by-Breath setup... 48 2.5.2.4 Hardware setup... 49 2.5.3 Ambient... 50 2.5.4 Date ... 50 2.5.5 User defined parameters ... 51 2.5.6 Language ... 51

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2.5.7 Protocol setup ... 52 2.5.7.1 Treadmill protocols... 54 2.5.7.1.1 Bruce protocol... 54 2.5.7.1.2 Ellestad protocol ... 54 2.5.7.1.3 Naughton protocol... 55 2.5.7.1.4 Astrand protocol... 55 2.5.7.1.5 Balke protocol ... 56 2.5.8 Gas cylinder ... 57 2.5.8.1 Gas Cylinder identification ... 57 2.5.8.2 Entering a gas cylinder number ... 57 2.5.8.3 Gas cylinder information ... 59 2.5.8.4 Standby of gas supply ... 59 2.5.9 Calibration... 60 2.5.9.1 O2 adjust ... 60 2.5.9.2 Flowmeter Calibration ... 60 2.5.9.2.1 Flowmeter Calibration procedure... 61 2.5.9.3 Gas delay calibration ... 61 2.5.9.3.1 Gas delay calibration procedure ... 62 2.5.10 Service ... 63 2.5.10.1 Signals ... 63 2.5.10.2 Signal Stat... 64 2.5.10.3 PGA Zero ... 64 2.5.10.4 PGA Mix... 64 2.5.10.5 Oxygen Cal. ... 65 2.5.10.6 Blood Pressure ... 65 2.5.10.7 Misc... 66 2.6 NIBP... 68 2.7 HELP SYSTEM... 69 2.8 DATA MANAGEMENT... 69 2.8.1 Export of data... 70 2.8.2 Script... 70 2.9 INNOCOR CONFIGURATION... 71 2.9.1 Calibration date... 72 2.9.2 Software code ... 72 2.10 EXIT / SHUT DOWN OF INNOCOR... 73 2.11 OFFLINE VIEWER... 74 3 DETAILED SOFTWARE DESCRIPTION... 75 3.1 HOW TO EXIT TO WINDOWS... 75 3.2 BASIC INSTALLATION ... 75 3.2.1 Native country ... 75 3.3 BACKUP OF DATA... 75 3.4 UPGRADING SOFTWARE... 76 3.5 FILE STRUCTURE ... 76 3.5.1 Databases... 77 3.5.2 Export... 77 3.5.2.1 Import of Innocor data into EXCEL ... 80 3.5.3 Help... 80 3.5.4 Language ... 80 3.5.5 Print... 80 3.5.6 Program ... 81 3.5.6.1 Drivers for exercise devices... 81 3.5.7 Protocol... 82 3.5.8 RAWDATA ... 83 3.5.9 RAWDATABBB... 83 3.5.10 SETUP ... 84 3.5.10.1 Increase max bolus concentration ... 86 3.5.10.2 Variable flow zero interval... 86 3.5.10.3 Printout to Microsoft EMF files (Enhanced Metafile) ... 87

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3.5.10.4 Beep support... 87 3.5.10.5 “Quick stop” for a treadmill... 88 3.5.10.6 Controlling the automatic flow-gas delay adjustment ... 88 3.5.10.7 Controlling the Vo2 calculation during a rebreathing test... 90 3.5.10.8 Setting the sampling rate to 100 Hz during rebreathing ... 90 3.5.10.9 Setting the drive letter for the first USB drive. ... 90 3.6 DATABASE... 90 3.6.1 Database recovery... 91 3.6.1.1 The screen layout ... 91 3.6.1.2 Verify database ... 92 3.6.1.3 Rebuild... 93 3.6.1.4 Override with backup ... 93 3.6.2 Database merge ... 94 3.7 LANGUAGE SUPPORT ... 95 3.8 SCRIPT SUPPORT ... 98 3.8.1 Search.sys ... 98 3.8.2 Script files (*.idm)... 99 3.9 PRINTER SETUP ... 100 3.9.1 Installation of new printer... 100 3.9.2 Print layout ... 100 3.9.3 Print layout header & footer ... 107 3.9.4 Preparing an image for the header & footer ... 108 3.10 HELP SYSTEM... 108 3.11 TIPS & TRICKS ... 108 3.11.1 Mouse support ... 108 3.11.2 Keyboard support... 108 3.11.3 Setting speed to km/h or mph... 109 3.11.4 How to recalculate rebreathing data ... 109 3.11.5 Running in parallel with an exercise device... 109 3.11.6 Corrupt gas bottle database ... 110 3.11.7 Generating images of graphics... 110 3.12 WINDOWS XP EMBEDDED ... 111 3.12.1 Control Panel ... 113 3.12.2 Backup boot up of windows XP embedded ... 114 3.12.2.1 How to boot from the alternative drive. ... 114 3.12.2.2 How to run Innocor software from the alternative drive. ... 115 3.12.2.3 How to use Microsoft Windows Recovery Console ... 115 3.12.2.4 How to change the default boot partition ... 115 3.13 NETWORK CONNECTION ... 116 3.13.1 How to find Innocor on a network using Windows XP ... 117 3.13.2 How to set IP address on Innocor... 118 3.13.3 How to set Computer Name on Innocor ... 119 3.13.4 How to install software from a CD-ROM on an Innocor... 120 3.13.5 How to perform a check of the hard disk ... 120 3.14 USB TO SERIAL CONVERTER ... 120 3.15 EVENT LOG ... 122

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1

INTRODUCTION AND APPLICABILITY OF THIS MANUAL

1.1

APPLICABILITY OF THIS MANUAL

This Software User Manual provides information about how to use the software on the Innocor. The information is more detailed than the one given in the Instruction for Use (COR-MAN-0000-001-IN) in various languages. Information on the Innocor hardware and service & calibration can be found in the Innocor Service Manual (COR-MAN-0000-002-IN). This manual is applicable for the software version 5.07. Section 1: Section 1.2 gives a short introduction to the Innocor. Differences between models are summarised in section 1.3. Section 1.4 lists the history of this document and section 1.5 lists the software changes. Section 1.6 defines the different symbols used in the Innocor software. Section 2 gives a general description of the Innocor software. Section 3 gives a more detailed description of the Innocor software. 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.

1.2

INTRODUCTION TO INNOCOR

1.2.1

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.

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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 on-line 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. Innocor runs under the Windows XP Embedded operating system on an integrated single-board computer. However, knowledge of Windows is not required to operate the device. The device is operated via a simple touch screen interface. Simply touch/press the buttons on the screen to invoke the desired functions. There is no significant warm-up time required for use of Innocor.

1.2.2

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, 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 is capable of understanding the instructions from the operator and performing the manoeuvre well. 1.2.3

Intended operators and environment

Unspecialised nurses and paramedics in all parts of the health care system can use Innocor. However, qualified medical personnel should always supervise the user.

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1.3

INNOCOR MODELS

Innocor is produced in different models. An overview of the models is given in the table below. Model Oxygen sensor Blood pressure sensor Breath-by-Breath INN0050 INN0100 √ INN0200 √ INN0300 √ √ INN0400 √ √ INN0500 √ √ √

1.4

SUMMARY OF REVISION CHANGES

A/4 A/5 A/6 A/7

18.05.04 20.10.04 31.03.05 16.03.07

1.5

SOFTWARE CHANGES

5.07 5.06 5.05

01.11.06 22.06.06 22.05.06

5.04

02.05.06

5.03 5.02 5.01 5.00

01.12.05 01.09.05 12.08.05 02.06.05

4.01 4.00

17.12.04 23.09.04

3.02

19.04.04

March 2007

First issue for software version 3.02 Updated to software version 4.00 Updated version Updated with Breath-by-Breath for software version 5.07

Script Support for updating system files (*.ini) Bug in controlling a manual treadmill protocol corrected Faster preparation of rebreathing bag Service interval reminder Native country Updates for the US market Breath-by-Breath updates New Export facilities Support for HR & BP from exercise devices Faster preparation of rebreathing bag Support for variable flow zero calibration interval Printout to Microsoft EMF files (Enhanced Metafile) Support for bolus concentration up to 50% Breath-by-Breath gas exchange calculation Improved regression lines in Data View New symbols Improved exercise protocol Scandisk in case of unauthorized power down Bug in O2-adjust corrected Exercise protocol Calculation of SVRI changed Calculation of SVO2 changed New handling of calculation warnings Standby of gas supply Improved bottle pressure handling Improved script handling Improved service menu Improved handling of databases in case of off-nominal shut down New trend function with support for display of parameters in tables and XY-plots Support for manual entering of HR, SpO2, Load, Speed, Slope Support for User defined parameters Support for calculated parameters based on database values Support for rebreathing bag volume down to 0.5 litre

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Improved on-line detection to avoid bag opening in the shift from inspiration to expiration. A test is always saved - also in case of errors - in order to display the data to determine the reason for the error. Support for deleting a gas cylinder from the Gas Cylinder list New exit / close down of Innocor New database format (3.02 will automatically convert existing format) Innocor software can run as an offline viewer on a memory key New help pages Support for setting of default printers Innocor software running under Windows XP embedded Estimation of bag volume to 40% of VC Automatic stop after 3 breaths after good mixing Support for beep during rebreathing Support for manual entering of blood pressure New parameters: Vo2/kg & A-V O2 diff. Support for script execution (Copy, Move, Delete etc.) Gas bottle identification implemented Support for different languages implemented

3.01 3.00 2.02

28.10.03 19.09.03 12.09.03

2.01 2.00

13.03.03 26.11.02

1.6

INNOCOR SYMBOLS

The Innocor software contains different groups of parameters and in order to distinguish between the parameters the following set of symbols is used: Parameters related to the subject: weight, height etc. Rebreathing parameters: CO, VL, SvO2, Vo2 etc. Breath-by-Breath parameters: VE, Vo2, Vco2 etc. 1 minutes averaged Breath-by-Breath parameters prior to a rebreathing Calculated parameters User defined parameters

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SOFTWARE DESCRIPTION

The main menu of the Innocor is displayed at power on:

• Press Measurement to make a test on a patient. • Press Setup to prepare general setup of the Innocor. Parameters that require alterations from test to test can be accessed directly from Measurement. Other setups like ambient conditions and language must be accessed through Setup. • Data Management is used to export data from the Innocor into text files and to execute script files in order to move/copy files from one media to another. • Blood Pressure is a stand-alone measurement of the blood pressure. • Press Exit to shut Innocor down.

2.1

ENTERING PATIENT DATA

When entering the measurement a patient must be selected before a test can be performed. The first time the patient is on the Innocor, the patient data must be entered. Next time the patient can be selected from the database. Choose New Pt (Pt=Patient) or Edit to enter the patient database section of the program. Press New Pt to enter data for a new patient. The following screen appears:

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Enter relevant data for the patient or test subject by pointing at the appropriate entry field using the alphanumeric keyboard. Press Select Male or Female from the selection list or type M or F on the keyboard to select the patient’s sex. 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. The following screen appears:

Enter one or more search criteria and press Filter to start the search process. Press Show All to disable all search criteria and display all patients. The wildcard ‘*’ is supported. After having entered or chosen the patient data, press the OK button.

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2.2

Innocor™ Software User Manual

MAKING A SINGLE MEASUREMENT

After a patient is selected the following screen appears. Results from the latest / previous test are shown if available.

Check that the bottle pressure is adequate (i.e. > 10 bar), and check that the rebreathing port is closed / inflated. Various data can be entered manually via the Pt. Data menu before or after the rebreathing test. See section 2.4.9 for further details. Press Test to prepare a new measurement. Enter or verify the patient data. Normal values for haemoglobin (Hb) concentration: Male = 8-11 mmol/l Female = 7-10 mmol/l When the patient data is entered, the user can select between a Single RB test and different protocols (option). After selecting the Single RB test the next screen appears:

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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 air and gas from the cylinder is filled into the bag. Option: It is a good idea to start a blood pressure (BP) measurement during the bag filling (the Start NIBP button), because it can be difficult to keep the arm quiet during the rebreathing manoeuvre. When the BP measurement is started, the current cuff pressure is shown in the status bar in the lower right corner of the main test window.

When the bag is filled, the following screen appears, showing gas concentrations, gas curves and the flow or airway pressure curve:

End-tidal

Note the end-tidal value of N2O and SF6. The N2O must be below 0.002% and SF6 below 0.001% in order to be able to ignore the effect of recirculation from the previous test. In other words: 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.

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Option: The BP measurement can be stopped / aborted (the Stop NIBP button) and restarted again under the test. Only the last measured values are saved in the database. Option: When the BP measurement is finished the resulting Systolic / Diastolic pressures are shown for 20 s in the status bar.

Put on the pulse oximeter finger clip sensor. Don’t use the arm where the BP cuff is positioned, if the measurements are done simultaneously. Connect to the mouthpiece and use a nose clip. Warning: Always remember to use a new disposable single patient use bacterial/viral filter with the mouthpiece. When the patient starts breathing into the mouthpiece, the Innocor starts calculating the breathing frequency. When a certain number of breaths have been detected (defined by “Pre-rebreathing breaths” in the setup, see section 2.5.2.1) the start button is enabled. Without the Breath-by-Breath option: If the mouthpiece pressure is very low the Innocor can not detect the breathing pattern, and the Start button will not be enabled. If this is the case mount the flexible flow restrictor on the RVU, see section 8 RVU description in the Instructions for Use. The status of the breathing can be checked in the lower left corner of the screen: It shall show “inspiration” during inspiration, “expiration” during expiration, and “--“ at no flow. 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 or subsequent expiration. When the valve shifts the patient should hold the breath for approximately 1 second to allow the valve to switch completely. The following screen appears:

Speed indicator

When breathing, try to follow the speed indicator. Breathe faster if the indicator is to the right of OK. Breathe slower if the indicator is to the left of OK. However an accurate breathing frequency is not critical for the calculations, but a too slow breathing can result in a too low O2 concentration or too high CO2 concentration in which case the test will be aborted before the planned stop, see section 2.5.1 for further details.

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It is essential that the rebreathing bag is being emptied completely during the first and the subsequent inspirations. The program shifts the valve on an end inspiration before the last expiration. The test is completed some seconds later (when the curves are not updated anymore). Option: If the BP measurement has not finished when the rebreathing test is finished, a message is shown to wait for the BP measurement. If the BP measurement is aborted by the Stop NIBP the RB test result will still be saved in the patient database.

Rebreathing test completed, but waiting on the NIBP measurement to finish.

The results are calculated and saved automatically in the experiment database. A raw data file containing the gas and mouthpiece signal is saved too – one file for each measurement. The results are shown immediately on the following screen (Results tab), see section 2.4.4.

2.3

PROTOCOL / EXERCISE EXECUTION

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 with respect to bag volume and bolus concentration. 2.3.1 Starting a protocol Starting a protocol is similar to starting a single rebreathing test: 1) Select Measurement 2) Select a patient 3) Press Test 4) Enter patient data (if any) The user will then be prompted to select a protocol, see section 2.5.7 for details on how to define a protocol. In the same menu the user can also change / select the exercise device, if controlled by the Innocor. At the moment the following exercise devices are supported, but more will come: • Elmed EGT 1000 ergometer • Ergoline VarioBike 550 ergometer • Ergoline 800&900 ergometers • Ergoline ergoselect ergometers • Lode Examiner ergometer • Lode Excalibur ergometer • Monark 839 ergometer • HP Cosmos Series treadmill The exercise devices are controlled via a USB/serial line. The USB to serial converter must be

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connected to the Innocor when powered on, otherwise the connection will fail. See section 3.14. CAUTION: The USB 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. The following 3 protocols are standard built-in protocols, which can not be changed by the user. - Auto Bicycle: A bicycle ergometer protocol where all settings are set to automatic and only a minimum is defined by the user just prior to the test. - Auto Treadmill: A treadmill protocol where all settings are set to automatic and only a minimum is defined by the user just prior to the test. - Single RB: A single rebreathing test without a protocol. Exercise profile

List of exercise protocols

Name of exercise device to be controlled

Toggle to change exercise device

When the protocol is selected an additional setup menu appears if any of the protocol fields are set to auto. The user checks / changes these auto fields and presses OK to start the protocol.

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Inc. load, Inc. slope, Inc. speed Min. load, Min. slope, Min. speed Time in step Min bag vol., Max bag vol.

Initial RB freq.: Steps between RB Steps between NIBP

Innocor™ Software User Manual

Incremental exercise level for each step in a protocol. The resulting exercise level is incremented by the value for each step starting with the minimum exercise level. The exercise level used for the first step in a protocol. The duration of each step in minutes. The duration of each step is identical, but can be changed during the protocol execution. The minimum / maximum bag volume allowed. The bag volume to be used during the protocol is automatically adapted according to the specified exercise level, but the Min and Max bag vol. sets the limits of the volume. The default Min. / Max. bag vol. is 44% / 75% of the predicted vital capacity of the subject. If the actual breathing frequency exceeds 30 /min the actual max bag volume will be reduced to “Max bag vol • 30 / Freq”. The guiding rebreathing frequency of the first step. The number indicates how often a rebreathing shall be performed. 0: never. 1: every step 2: on every second step, etc. The number indicates how often a NIBP measurement shall be performed. Since the NIBP measurement must be done together with a rebreathing measurement, the number must be a multiple of ”steps between RB”.

2.3.2 Running a protocol When a protocol is started the user can select between 2 or 4 screens using the Show… button: Protocol screen Result screen Breath-by-Breath screen (only available with BbB) On-line raw data screen (only available with BbB)

2.3.2.1 Protocol screen The protocol screen lists the protocol in table form with only the active step highlighted - the other steps are dimmed. When a step is performed, it is marked with √ in the step column. In user defined protocols the complete number of fields is shown, whereas the automatic protocols only show the next step to be performed. The content of an auto field is first defined when it is the next step to be performed, because the prediction of the values are based on the results from the previous step. The Innocor S/W makes a pre-estimation of the maximum CO2 and the minimum O2 level for all the

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steps in a user defined protocol, and if a value is outside the specified limits, a red exclamation mark is shown in the step/action column. As the protocol progresses the estimations become better, but if a limit violation still exists on the next step to be performed, the user is prompted with the warning. Normally the user does not need to enter the protocol setup. However the protocol setup can be used to view the progress of the protocol or to change the protocol on-line. Edit field Active step

Performed steps

RB on

NIBP on

Auto calculation

Increment / decrement buttons

2.3.2.1.1 Changing protocol parameters on-line The user can change the individual parameters of the protocol prior to the bag preparation (1 minute after the last rebreathing procedure). When the bag preparation starts, the parameters of the active step are locked while the step is performed. To change a parameter the user presses first the field, then the “+” or “–“ buttons to increment or decrement the value. Note the value in the actual step and all subsequent steps are increased or decreased by the same amount. The following increments are used: Load Slope Speed Time/Duration Bag volume Bolus fraction RB. frequency

± 5 watt ±1% ± 0.5 mph or km/h ± 10 seconds ± 0.1 litre ±1% ± 1 /min

Normally the protocol automatically progresses through all steps, however pressing the “Go to step” button can change the active step both forward and backwards. By using this feature, steps can be both skipped and repeated. When a new step is selected, the protocol progress starts from this position and the time to rebreathing is reset. If the parameter editor (blue field) is positioned on the active step, the “Go to step” button changes to a “Start rebreathing” button. Pressing this button immediately starts/completes a bag preparation followed by a rebreathing test. This can be useful if the subject is close to the maximum exercise level and is not able to complete the step within the planned duration. The “RB on/off” button is used to turn on/off the rebreathing related to the step. Similarly with the “NIBP on/off” button. However, the NIBP can only be on if the RB is on.

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2.3.2.1.2 Protocol estimation The Innocor S/W uses different formulae in order to estimate the correct bag volume and bolus fraction. The prediction of oxygen uptake (Vo2) uses the following formulae: Vo2 (rest)

= 0.0035 • Weight

Vo2 (bicycle)

= 0.0035 • Weight + 0.01 • Load

Vo2 (treadmill-walk) (Speed < 7 km/h)

= 0.00332•Weight•[2.3+0.32•(Speed-2.5)1.65+Slope•(0.2+0.07(Speed-2.5))]

Vo2 (treadmill-run) (Speed > 7 km/h)

= 0.00332•(E+0.47•(900-E))•(1+Slope/100) E = Weight•[2.3+0.32•(Speed-2.5)1.65+Slope•(0.2+0.07(Speed-2.5))]

where Vo2 = l/min Weight = kg Load = watt Speed = km/h Slope = % The formulae for the Vo2 estimation on the treadmill is from "Predicting metabolic energy cost, by Baruch Givoni and Ralph F. GoldMan, Journal of applied Physiology, vol. 30, No 3, March 1971", The prediction formulae of the Vo2 on a bicycle is relatively independent of the subject, whereas the prediction on the treadmill is more subject dependent due to different walking & running efficiency. The estimation of Vo2 is automatically adapted during a protocol using the actual measurement on the previous step, and the prediction formulae thereby become less sensitive to subject variations: Vo2,estimation = Vo2(previous) + ∆Vo2,estimation(change in exercise level) The Vo2 estimation is used to calculate the needed oxygen contents of the rebreathing bag. During the estimation of the bag volume / bolus fraction the Innocor S/W first tries to increase the bolus fraction in order to get enough oxygen (the bolus gas contains 94% O2). If this is not enough the bag volume is increased too. The Innocor S/W contains an estimation of the maximal CO2 concentration in the bag at the end of a test. This is also taken into account when the bag volume is estimated. A third factor affecting the bag volume is the length of the time breathing in and out of the bag. The time is determined by the breathing frequency and the number of breaths to achieve 3 good breaths. The estimation starts up assuming 5 breaths to achieve 3 good breaths, but uses thereafter the actual breathing frequency and number of breaths found in the previous test.

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2 sets of typical estimations of the bag volume based on the O2 and CO2 requirements are shown below. The recommended minimum bag volume (44% of Vital Capacity) and maximum bag volume (75% of Vital Capacity) are shown as 2 horizontal lines. Weight BolusFraction CO2,max O2,min Freq

70kg 10% 8% 13% 20 - 30

Vbag (L)

Vbag-CO2

Vbag-O2

5 4.5 4 3 .5 3 2.5 2 1.5 1 0.5 0

75% of VC 44% of VC

0

50

100

150

200

250

Load (W)

Vbag (L)

Vbag-CO2

Vbag-O2

5 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0

75% of VC 44% of VC

0

0.5

1

1.5

2

2.5

3

VO2 (l/min)

The relatively slow increase in Vbag due to the O2 requirement in the mid range is caused by the increased breathing frequency and a reduced number of breaths (from 5 to 4) typical in this range.

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Weight Bolus Fraction CO2,max O2,min Freq

70kg 10% 10% 13% 20 - 30

Vbag-CO2

Vbag-O2

4 3.5

75% of VC

Vbag (L)

3 2.5 2

44% of VC

1.5 1 0.5 0 0

50

100

150

200

250

Load (W)

Vbag-CO2

Vbag-O2

4 3.5

75% of VC

Vbag (L)

3 2.5 2 1.5

44% of VC

1 0.5 0 0

0.5

1

1.5

2

2.5

3

VO2 (l/min)

It is seen that the CO2 requirement is dominating with 8% maximum CO2, and the O2 requirement is dominating with 10% maximum CO2. The subject can reach 250 watt / 39 ml/min/kg using the last setup. If the subject can perform more, one of the following parameters must be increased: - The bolus fraction, - the bag volume or - the breathing frequency

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