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CPET Instructions for use Version: 4 Release date: 01 April 2022 Please read carefully and store in a place which is always accessible for future consultation!
It is intended to provide you with instructions for its proper use and safe operation. This IFU has been written for healthcare professionals who are qualified to perform Cardiopulmonary Exercise Testing (CPET) examinations. The basic prerequisite for safe working with the product is to follow all the safety instructions given.
Abbreviations The following simplified style of writing and abbreviations are used hereinafter to make this IFU easier to read. Instructions for Use IFU Geratherm® Respiratory GmbH Manufacturer Medical specialist personnel User(s) Personnel instructed in cleaning / maintenance work ...
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Instructions for Use CPET Indicates a directly hazardous situation. Not observing and not avoiding the situation will lead to death or severe injuries. The signal word DANGER is only used for extreme situations. Indicates a possibly hazardous situation. Not observing and not avoiding the situation may lead to death or severe injuries.
Instructions for Use CPET Copyright The manufacturer reserves all rights to this document and the information contained therein. No part of this document or the information contained herein may be reproduced or transmitted without the written consent of the manufacturer. All information or brand names of a third party contained in this document are subject to the copyright of that third party.
Instructions for Use CPET Safety in Handling In order for the device or the total system to be operated in accordance with its intended use, the safety information and procedures in this IFU as well as the IFU of the device itself must be understood.
Instructions for Use CPET General Safety at Work and Personnel Qualification Possible danger to life. Reason: False diagnosis. Ignoring contraindications. Triggering malfunctions during measurement. Unqualified user / operator can detect sources of failures too late or even cause them. Therefore: •...
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Instructions for Use CPET Reason: Side-effects (i.e. cardiac arrythmia) triggered by exercise. Therefore: • Perform exercise tests only in presence of a physician! • Ensure availability of resuscitation equipment (defibrillator, medications) and trained emergency personnel! • Monitor cardiac function with appropriate methods (e.g.
Information on indication, contraindication and side effects can be found in the IFU of the device with which the examination is performed. CPET is the determination of physical performance by measuring gas metabolism. The interaction of heart, circulation, breathing and metabolism is analysed during defined physical exercise.
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Instructions for Use CPET Restrictions of gas exchange (Diffusion/Ventilation/Perfusion) (e.g. interstitial lung disease, pulmonary hypertension, heart failure). • VE/VO (respiratory equivalent for O • VE/VCO (respiratory equivalent for CO • PETO (end-tidal partial pressure of oxygen) • PETCO (end-tidal partial pressure of carbon dioxide) For a systematic evaluation of the measurement results, the presentation in 9 fields according to Prof.
3.1.1 Software BLUE CHERRY® - Controls Presentation: Button Function Start measurement Select CPET measurement Print measurement results Recalculate measurement results Edit raw data of the examination Call the Wizard to evaluate the examination Open associated stress ECG examination Call up event table...
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Instructions for Use CPET Restart measurement Save current measurement and start new measurement Start flow / volume measurement Entering the FEV1 Perform zero adjustment Enter comments Entering the blood gases Selection of the Borg Index Review and edit event types blood pressure, blood gases...
Therefore: • Do not use single-use products more than once! For the performance of the CPET examination, preparations on the respective devices are necessary. A detailed description of the specific system design and necessary calibrations can be found •...
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Instructions for Use CPET Patient preparation: Before the examination, the patient must be informed about the entire examination procedure. Measurement with mouthpiece: Make sure that the nose is closed and the mouthpiece is firmly enclosed with the mouth. Measurement with mask: Put the mask on the patient according to the instructions.
Depending on the ECG used, the examination is started from the ECG software. Please refer to the ECG manufacturer's manual. To perform a CPET examination, the BLUE CHERRY® software must first be started. Then follow the steps below. page 18...
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Instructions for Use CPET 1. Select CPET. For this: Select the "CPET" [1] button on the left. After starting the measurement, the zero point is determined. For this, the connection to the sensor is automatically disconnected via valves so that the...
Instructions for Use CPET 3.1.3.1 Screen Layout During the Examination [1] Control bar for performing actions [2] Selecting the screen view [3] Controlling the load profile [4] Displaying measurement results in graphs and tables The toolbar at the top of the screen can be used to influence the examination process.
3.1.3.2.1 Device Selection In combination with certain ECG programmes, the ECG software takes over parts of the functionality. • See ECG IFU After starting the CPET measurement, buttons become visible in the left area. The following devices are available for selection:...
Instructions for Use CPET After selecting the pull-down menu next to the heart rate symbol, the device to be used for heart rate measurement can be selected. All connected or installed devices are available for selection. 3.1.3.2.2 Selection of the Load Protocol In combination with certain ECG programmes, the ECG software takes over the load control.
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Instructions for Use CPET Settings Function Reference Selection of the method for the target load calculation. method Available are: • Last test: Target load is taken from the last load test carried out. • Reference value: Target load is calculated from the reference equation (can be set in the setup).
Instructions for Use CPET load after the given loading period, in the comparison to the target load. 3.1.3.2.3 Set Mask Size Since for some parameters the appartive dead space is taken into account in the calculation, this must be set correctly for the examination.
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Instructions for Use CPET 1. Record flow / volume measurement. For this: Press the "F/V" [1] button. Take calm and relaxed breaths as instructed until even breathing is achieved. As instructed from normal breathing, slowly exhale completely. The "Plateau" indicator on the right side of the screen is used to control deep expiration.
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Instructions for Use CPET Inhale slowly and completely according to instructions. Exhale quickly and completely according to instructions. Inhale quickly and completely according to instructions. Take calm and relaxed breaths as instructed until even breathing is achieved. page 26 Version: 4 | Release date: 01 April 2022...
Instructions for Use CPET 2. Save the measusrement. For this: Press the "Save" [2] button. 3.1.3.2.5 Input FEV1 Measured Value To determine the breathing reserve, the patient's maximum voluntary ventilation is required. This is determined according to the following methods depending on the available data: •...
Instructions for Use CPET 2. Enter measured value for FEV1 3.1.3.3 Running through Load Phases In combination with certain ECG programmes, the ECG software takes control over the examination procedure. • See ECG IFU 3.1.3.3.1 Start Recording / Rest Phase 1.
Instructions for Use CPET The examination starts first with the rest phase. In this phase, the measured values are determined without physical exercise as a reference for the subsequent exercise. In this phase, the patient should come to rest as much as possible. In addition to stable measured values, it is important to ensure that the patient does not hyperventilate (VE clearly above 10l/min, RER above 1.00).
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Instructions for Use CPET Termination criterion Absolute Relative ST segment depression ≥ 3 mm ST segment elevation ≥ 1 mm Blood pressure drop > 10 mmHg (compared to baseline blood pressure) with signs of myocardial ischaemia (angina pectoris, ST-segment depression)
Instructions for Use CPET 3.1.3.3.3 Start of the Recovery Phase 1. Start recovery. For this: Press the "Recovery" [1] button. In the recovery phase, the physical exercise for the patient is reduced to a low level. During the recovery phase, the measured values continue to be recorded continuously.
Instructions for Use CPET 3.1.3.3.4 Saving the Investigation 1. Save measurement. For this: Press the "Save" [1] button. 2. Select the reason for termination. For this: In the automatically opening window, select a reason for termination [2] or optionally add a text [3] and then press "Accept".
Instructions for Use CPET 3.1.3.4 Control Load Protocol In combination with certain ECG programmes, the ECG software takes control over the examination procedure. • See ECG IFU The display of the phase contains both an indication of the current phase and the remaining duration of the phase.
Instructions for Use CPET 3.1.3.5 Events During the Investigation 3.1.3.5.1 Comments 1. Enter a comment. For this: Press the "Comment" [1] button. The previous comment and an automatic text with current time and load is displayed. Edit comment and save with "Accept".
Instructions for Use CPET 3.1.3.5.2 Blood Gases 1. Mark blood gas sampling. For this: Press the "Blood gases" [1] button. A notification window confirms the marking of the blood gas sample. Version: 4 | Release date: 01 April 2022 page 35...
Instructions for Use CPET 3.1.3.5.3 Borg 1. Enter Borg. For this: Press the "Borg" [1] button. Select the patient's current stress level using the Borg scale. The Borg scale used can be defined in the settings (see chap. 5.1) page 36...
Instructions for Use CPET 3.1.3.5.4 Blood Pressure 1. Open the blood pressure input. For this: Press the "Blood pressure" [1] button. Enter the current blood pressure and then press "Accept". Version: 4 | Release date: 01 April 2022 page 37...
Instructions for Use CPET 3.1.3.5.5 Edit Events 1. Open event input. For this: Press the "Events" [1] button. Select the type of event via the tab [2] and correct values via the input mask [3] or create a new event via "Add"...
Instructions for Use CPET 3.1.3.5.6 Record Tidal Loops 1. Record tidal loops under load. For this: Press the "Tidal loop [1]" button. Take calm and relaxed breaths as instructed until even breathing is achieved. Inhale slowly and completely according to instructions and...
[2] Selection of the examination A variety of graphical and numerical information is available to assess the measured values of CPET. Various reports are available for this purpose, each containing specific information and between which you can switch in the display.
Instructions for Use CPET The reference value at maximum load is displayed as a horizontal line. In the graphs, the recorded measured variables are displayed in various forms over the course of the examination. The reference values and corridors contained in the graphs make it easier to assess the measured values.
Instructions for Use CPET 3.1.4.1.3 Continuous Data Representation CPET Breath-by-breath For the assessment of the measured values over the course of the examination, they can be displayed in tabular form. Various options for averaging and filtering the data are available for this...
Instructions for Use CPET 3.1.4.1.4 Tidal Loops Representation of tidal loops [1] Resting- flow/volume loop [2] Tidal loops [3] Selection of edited tidal loop [4] Cursor for ERV correction [5] Cursor for IRV correction [6] Table with measured values of the tidal loops...
Instructions for Use CPET 3.1.4.1.5 Interpretation Presentation Interpretation The interpretation table summarises important parameters of CPET. An interpretation is also given for each of the individual parameters. 3.1.4.1.6 Training Areas Training illustration [1] Training zones [2] Parameters for training control...
With the help of the training plan, the training for a tested person can be planned based on the results of the CPET. The training plan is the result of the training wizard and contains all the necessary information that the tested person needs to carry out the training.
BLUE CHERRY® offers correction options for slope lines and different cursor positions. The software usually evaluates the measured parameters of the CPET examination very well on the basis of the measured curve. Nevertheless, in individual cases it may be necessary to correct the measurements manually.
Instructions for Use CPET 3.1.4.2.2 Adapt Regression Lines 1. Move the mouse pointer to a line that you want to correct. The cursor changes to a hand. 2. Press the left mouse button and keep it pressed. Move the line with...
Instructions for Use CPET 3.1.4.2.3 Correct Tidal Loops By selecting the visible loop, the loop is displayed in the graphics area. By selecting the loop to be edited, the result is displayed in the graphics area and can be changed manually by clicking on the element with the mouse.
Instructions for Use CPET 3.1.4.3 Events (Blood Gases, Blood Pressure, Borg) 1. Enter parameters. For this: Press the "Events" [1] button. A input window opens. All events that have already been marked during the measurement are displayed and can be edited.
Instructions for Use CPET 3.1.4.4 Wizard 1. Open evaluations of the examination results. For this: Press the "Wizard" [1] button. The following window appears for the load. List of the exertion criteria [2]. Graphical representation of the exertion criteria [3].
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Instructions for Use CPET Based on the settings and the examination results, BLUE CHERRY® automatically creates a proposal for the assessment of the exertion in the top line. You can change this assessment at any time by clicking on the symbol and after selecting "Accept"...
Instructions for Use CPET 3.1.4.5 Interpretation To support you in the interpretation of the CPET examination, the interpretation algorithm according to Karlman Wasserman (Principle of exercise testing and interpretation 3rd edition) is integrated in BLUE CHERRY®. The following window appears for the interpretation.
Depending on the results of the CPET examination, BLUE CHERRY® has already predefined the training areas. After specifying the type of sport, the training goal, the number of training units per week or training days, the start date and the duration, BLUE CHERRY®...
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Instructions for Use CPET Settings Function Calculation Selection of the threshold model (VT2 / VT1) or the heart rate model (maximum HR model) to determine the training zones. Regeneration Heart rate for the regeneration training phase (see tables below for determination)
Instructions for Use CPET 3.1.4.6.1 Cycling Training Areas VAT Threshold Model: Designation Intensity (in % of the VT1 threshold load) Regeneration HF at load start - HF at VT1 Extensive HF at VT1 - HF at 120% of the load at VT1...
Instructions for Use CPET 3.1.4.6.2 Training Areas for Running RCP threshold model: Designation Intensity Regeneration HF at load start - HF at 82.5% of load at VT2 Extensive HF at 82.5% of the load at VT2-HF at 92.5% of the load...
Instructions for Use CPET 3.1.4.6.3 Edit Training Plan Clicking on the date opens a window for changing the day. The duration can be edited by clicking in the field. Changing the duration automatically recalculates the energy consumption. Clicking on the Intensity...
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Instructions for Use CPET The description of the training session can be changed after clicking in the description field. Clicking on the energy consumption area opens the window for determining the energy consumption. For this purpose, it must be specified how long training will be done at which heart rate.
Instructions for Use CPET Parameter Description CPET Name Unit Description Time min:sec Test time Load Load Speed km/h Speed Elev Elevation 1/min pedal speed l/min Oxygen Uptake VO2 = ∫ ( ) ∆2 2 − 2 − 2 2 ∆2 =...
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Instructions for Use CPET Name Unit Description Inspired volume Duration of inspiration Tidal volume 1/min Breathing frequency l/min Minute Ventilation VE = ∫ ( ) l/min Breathing reserve BR = MVV - VEpeak MVV = Maximum Voluntary Volume (FEV1x35)
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Instructions for Use CPET Name Unit Description Endtidal fraction of O concentration Endtidal fraction of CO concentration Inspiratory fraction of O concentration FiCO Inspiratory fraction of CO concentration PETO mmHg End tidal O pressure PETCO mmHg End tidal CO pressure...
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Instructions for Use CPET Name Unit Description P(A-a)O mmHg Alveolar - Arterial PO difference 2 P(A-a)O = PAO - PaO 2 = 2 ( − 47 ) − PB = ambient barometric pressure in mmHg...
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Instructions for Use CPET Name Unit Description Energy kcal/min Energy consumption Vd(b) 2 − 2 Dead space volume = − 2 Vt = Tidal volume PaCO = arterial PCO PECO = mixed expired PCO Vdm= mask dead space Vd(b)/Vt ()
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Instructions for Use CPET Name Unit Description kcal/24h Resting Energy Expenditure REE = (3.9 x VO + 1.1 x VCO ) x 1.44 Delay Delay in rise of O signal Delay Delay in rise of O signal REE/BSA kcal/24h/m² Resting Energy Expenditure per Body Surface Area ×...
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Instructions for Use CPET Name Unit Description ml/min/kg Carbon dioxide production per body weight /kg = VCO / body weight x 1000 Offset Offset for inspiratory fraction of O concentration Load/kg W/kg Load per body weight PECO mmHg Mixed expired PCO...
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Instructions for Use CPET Name Unit Description (AT) Oxygen consumption at anaerobic threshold in percent of VO VE/VO (AT) l/min Ventilatory equivalent for VO at anerobic threshold beats/min Heart rate l/min Oxygen consumption Load (Lipox) Load at LIPOXmax point Load/Ref (Lipox)
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Instructions for Use CPET Name Unit Description (peakVO mmHg Arterial oxygen partial pressure at VO PaCO (peakVO mmHg Arterial carbon dioxide partial pressure at VO P(A-a)O (peakVO mmHg Alveolar - Arterial PO difference at VO P(a-ET)CO mmHg Arterial End-tidal PCO...
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Instructions for Use CPET Name Unit Description l/min Minute ventilation at VO Load Load at VO Load (i) Interpolated load at VO Time min:sec Duration of load phase l/min at VO /kg (AT) ml/min/kg Oxygen uptake per body weight at anaerobic...
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Instructions for Use CPET Name Unit Description PaCO (Rest) mmHg Arterial carbon dioxide partial pressure at rest /Ref. (RCP) Oxygen consumption in percentage of predicted at respiratory compensation point Oxygen uptake efficiency slope OUES OUES is derived from the slope of VO...
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Instructions for Use CPET Name Unit Description Mean expiratory fraction of O concentration Inspiratory fraction of O concentration Log(VE) log(l/min) Logarithm of minute ventilation Load (m) Measured load Speed (m) km/h Measured speed Elev. (m) Measured elevation 1/min Rowing frequency (Rowing machine)
If activated FiO will be set to 20.94 FiCO If activated, FiCO is measured during inhalation. Enable logging If activated, the raw data of the CPET measurement will be saved additionally. Version: 4 | Release date: 01 April 2022 page 71...
Instructions for Use CPET Load Profiles Setting Function Ergometer Adding, removing, copying and configuring load profiles profiles for bicycle and hand crank ergometers Treadmill Add, remove, copy and configure load profiles for profiles treadmill ergometers Treadmill start If activated, a warning is displayed before starting the...
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Instructions for Use CPET Setting Function Name Name for the load profile Test type Selection for which test type the load profile is to be generated and displayed later. You can select All, Max. VO , Lactate test and Lipox test.
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Instructions for Use CPET Setting Function Phase Selection of the load phase. Rest, warm-up, load and recovery are available for selection. Duration Duration of the load level Load Load in W Speed Speed in Km/h Elevation Inclination in % With the help of the "Stage profile" button, a new step profile can be inserted into the selected load profile.
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Instructions for Use CPET Setting Function Inclination Increment Increase of the inclination per level The "Ramp" button can be used to insert a new ramp profile into the selected load profile. The following setting options are available: Setting Function Phase Selection of the load phase.
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Instructions for Use CPET The "Remove" button removes the selected level from the profile. The "Configure" button allows you to change the settings for the selected level and the "Up or Down" buttons can be used to change the sequence.
Instructions for Use CPET Exercise Stop In the selection area, reasons for termination can be added or deleted. The following setting options are available: Setting Function Name Name for the reason for exercise stop Parameter Setting a parameter that is monitored for exercise stop...
Instructions for Use CPET Events Here you can set how the events Borg entry, blood pressure and blood gases are to be handled during the examination. It is also possible to create and enter all events after the examination. Setting...
Instructions for Use CPET CPET Views In the selection area, screen displays for CPET examinations can be added or deleted and their order can be changed. The following setting options are available: Setting Function Name Name of the representation Visible...
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Element selection The following element types are available: Depending on the selected element type, certain elements are available in the line CPET Graphic. The following shows the selection option for the element type Table Test Data: page 80 Version: 4 | Release date: 01 April 2022...
Instructions for Use CPET Display CPET Setting Function Last load If activated, the maximal reached load will be calculated by using the real stage duration of the last load stage. Exp. Time in s after which point the final load level is taken as the duration maximum load level.
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Instructions for Use CPET Wizard Configure which values the integrated wizard should display. All possible values can be opened by the Setup button. It´s possible to select multiple entries by using the CTRL-Key. Max effort Configure which criteria should be displayed for the criteria detection of a max effort.
Instructions for Use CPET CPET Plots Setting Function Name Graphic name X-Axis Parameters for X-Axis Y-Axis 1 Parameters for Y-Axis 1 Y-Axis 2 Parameters for Y-Axis 2 Y-Axis 3 Parameters for Y-Axis 3 Y-Axis 4 Parameters for Y-Axis 4 Cursors...
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Instructions for Use CPET Setting Function Parameter The "Setup" button can be used to select from a list of parameters for the X-Axis. Ref. values Setting the reference values for the selected parameter Scaling Setting the scaling Load profile Switch the display of the load profile for the graphic on or off.
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Instructions for Use CPET Setting Function Parameter The "Setup" button can be used to select from a list of parameters for the Y-Axis. Colour Colour selection Curve mode Selection of whether lines or points are displayed Thickness Adjusting the line thickness Ref.
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Instructions for Use CPET Setting Function No filtering No filtering, the raw data is displayed. Combined Filter The data is sorted and then the mean value is calculated from the middle range. Moving average The data is continuously summed up and divided by the number of data.
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Instructions for Use CPET After selecting the "Setup" button in the Phases line, the following setting can be made: Selection of which phases are to be displayed. Multiple selection is possible with the help of the CTRL key. After selecting the "Setup" button in the Cursors line, the...
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Instructions for Use CPET Setting Function Y-Axis Parameter selection for the regression calculation Change direction Selection field for the regression line(s). The following is available for selection: • None: Only a straight line • Both: 2nd straight flatter or steeper •...
Instructions for Use CPET Setting Function Show for Line 2 - Show offset to regression line 2 Offset Show for Line 2 - Show inclination to regression line 2 Inclination Fixed inclination If activated, the regression line 1 always has the specified level.
Instructions for Use CPET Training Ranges For each training area in BLUE CHERRY® there is an entry in the selection area. In the configuration area, the following settings can be made for additionally added training areas: Setting Function Name Designation for the training ranges Min.
Instructions for Use CPET " " " " When you select and then Setup , the following screen appears: Here you can enter a description for the HR range, the intensity, the training and the lower or upper limit of the heart rate. After selecting "Setup", a formula editor appears for entering the...
Instructions for Use CPET Setting Function Name Designation for the training unit Sport Selection of the sport. The choices are running and cycling. Intensity Entering the intensity Colour Colour selection Duration If activated, the entered duration is always used. Otherwise the duration is set automatically.
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Instructions for Use CPET Setting Function Name Designation for the training plan Sport Selection of the sport. The choices are running and cycling. Days / Week Select the lower or upper limit for the number of training days per week.
Instructions for Use CPET Fault Indication and Repair Simple errors which occur when using the product can be recognised quickly and rectified using the following table. If you cannot find the error in the table or the problem cannot be rectified using the method described, please contact your specialist retail partner.
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Instructions for Use CPET Error Rectification Button for starting the measurement Check the connection of the device to is missing the PC Check the rights of the logged-in user When calling via an interface (GDT, HL7) check the requested examination type...
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Instructions for Use CPET Error Rectification No heart rate Check correct fit of electrodes / chest strap / SpO sensor Check ECG signal for quality Check interface setting to ECG software Error message "Significant deviation Carry out a new gas calibration during zero adjustment detected".
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Instructions for Use CPET Error Rectification Replace filter and Permapur Carry out gas calibration again Check the device for faults, see the IFU of the device Other obvious measurement error Check the fit of the mask / noseclip Make sure that the patient tightly...
Instructions for Use CPET Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www.geratherm-respiratory.com/login/ See depositors page 98 Version: 4 | Release date: 01 April 2022...
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