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Instructions for Use

CPET

Version: 4 | Release date: 01 April 2022

page 9

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.

Ensure that these are followed!

Otherwise, in the worst case, death or severe injuries
are the consequence resulting from the risks

described in more detail in the respective chapters!
Therefore:

•

Read this IFU carefully and in its entirety

before performing measurements. Keep it in

close proximity to the medical device for later
reference and make it accessible to the user /
operator at all times!

•

Also observe the safety information of all other
accompanying documents of the total system!

•

If you have any questions, ask your authorised
specialist retail partner!

Содержание CPET

Страница 1: ...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...

Страница 2: ...English Software version 1 3 3 1 Geratherm Respiratory GmbH Kasernenstra e 4 97688 Bad Kissingen GERMANY Tel 49 971 7857043 0 Fax 49 971 7857043 30 info geratherm respiratory com www geratherm respira...

Страница 3: ...Load Protocol 22 3 1 3 2 3 Set Mask Size 24 3 1 3 2 4 Recording the Rest Flow Volume Curve 24 3 1 3 2 5 Input FEV1 Measured Value 27 3 1 3 3 Running through Load Phases 28 3 1 3 3 1 Start Recording R...

Страница 4: ...org 49 3 1 4 4 Wizard 50 3 1 4 5 Interpretation 52 3 1 4 6 Training Planner 53 3 1 4 6 1 Cycling Training Areas 55 3 1 4 6 2 Training Areas for Running 56 3 1 4 6 3 Edit Training Plan 57 4 Parameter D...

Страница 5: ...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 In addition to the n...

Страница 6: ...s Personnel instructed in cleaning maintenance work Operator s 1 2 Explanations For the safety of your patients for your personal safety and to avoid damage to property observe the meaning of the foll...

Страница 7: ...ng and not avoiding the situation may lead to death or severe injuries Indicates a possibly hazardous situation Not observing and not avoiding the situation may lead to minor or moderate injuries Indi...

Страница 8: ...pyright of that third party 1 4 Limitation of Liability The manufacturer emphasises the creation of accompanying documents for his products Despite careful checking errors or inaccuracies in this docu...

Страница 9: ...Otherwise in the worst case death or severe injuries are the consequence resulting from the risks described in more detail in the respective chapters Therefore Read this IFU carefully and in its enti...

Страница 10: ...nance Possible danger to life Reason Disregard of a contraindication Misdiagnosis caused by measurement error For this Observe the general medical principles Therefore Inform yourself and observe the...

Страница 11: ...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 emergen...

Страница 12: ...sly recorded Both the measured values achieved under maximum load e g VO2max and the development of the individual parameters under load especially at the thresholds VT1 and VT2 provide information ab...

Страница 13: ...ratory equivalent for CO2 PETO2 end tidal partial pressure of oxygen PETCO2 end tidal partial pressure of carbon dioxide For a systematic evaluation of the measurement results the presentation in 9 fi...

Страница 14: ...t 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...

Страница 15: ...t 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 and Borg...

Страница 16: ...ation preparations on the respective devices are necessary A detailed description of the specific system design and necessary calibrations can be found In the IFU of the respective device Electrocardi...

Страница 17: ...on the patient according to the instructions Make sure that the mask fits tightly and seals tightly Connect the sensor to the mask adapter and check the tightness of the mask and sensor The patient s...

Страница 18: ...xamination 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...

Страница 19: ...measurement the zero point is determined For this the connection to the sensor is automatically disconnected via valves so that the patient can already breathe at the sensor Afterwards the breathing s...

Страница 20: ...The toolbar at the top of the screen can be used to influence the examination process In addition comments see chap 3 1 3 5 1 events see chap 3 1 3 5 5 blood pressure values see chap 3 1 3 5 4 or the...

Страница 21: ...Heart rate monitors 4 Protocol symbol After selecting the pull down menu next to the ergometer symbol the ergometer treadmill to be used for the examination can be selected All connected or installed...

Страница 22: ...the load control See IFU of the ECG After selecting the drop down menu next to the protocol symbol the load protocol to be used for the examination can be selected A list with the most commonly used...

Страница 23: ...d is calculated from the measured FEV1 of the flow volume test Best Pre from the same day Climbing stairs Target load is calculated from anamnesis How many stairs can you climb Reference load Display...

Страница 24: ...Press the Test options 1 button Select the mask mouthpiece used 3 1 3 2 4 Recording the Rest Flow Volume Curve The recording of the tidal loops is used to determine dynamic hyperinflation under exerc...

Страница 25: ...eathing 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 According to ATS ERS guideline...

Страница 26: ...01 April 2022 Inhale slowly and completely according to instructions Exhale quickly and completely according to instructions Inhale quickly and completely according to instructions Take calm and relax...

Страница 27: ...he patient s maximum voluntary ventilation is required This is determined according to the following methods depending on the available data Performed MVV measurementt Calculation from FEV1 Factor Usu...

Страница 28: ...ation 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 Start investigation For this Press the Start 1 button...

Страница 29: ...the rest phase the events can be used to record additional data via the toolbar see chap 3 1 3 5 3 1 3 3 2 Start of the Load Phase 1 Start load For this Press the Load 1 button In the exercise phase...

Страница 30: ...cyanosis X Persistent duration 30 sec ventricular tachycardia X Patient exhaustion X Technical problems defective ECG registration X Hypertensive dysregulation Rrsyst 230 260 mmHg Rrdiast 115 mmHg X...

Страница 31: ...recovery phase the measured values continue to be recorded continuously This serves among other things to detect stress induced side effects With the start of the recovery phase the face mask can be...

Страница 32: ...l 2022 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 termi...

Страница 33: ...ion of the stage Via the button Hold the load of the current level can be maintained The next stage can be started via the Next button The display of the load contains both the current load of the erg...

Страница 34: ...date 01 April 2022 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 lo...

Страница 35: ...or Use CPET Version 4 Release date 01 April 2022 page 35 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...

Страница 36: ...36 Version 4 Release date 01 April 2022 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...

Страница 37: ...or Use CPET Version 4 Release date 01 April 2022 page 37 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 p...

Страница 38: ...e date 01 April 2022 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 vi...

Страница 39: ...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...

Страница 40: ...mation 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 3 1 4 1 1...

Страница 41: ...sier to assess the measured values With the help of the regression lines and cursors the different thresholds can be determined and defined during the examination see chap 3 1 4 2 2 3 1 4 1 2 Threshol...

Страница 42: ...averaging and filtering the data are available for this purpose Representation Averaging and filtering Breath by breath One data set per breath Load levels One data set per load level Time interval On...

Страница 43: ...loop In this diagram the tidal loops recorded under load are shown in relation to each other and in relation to the resting flow volume loop This allows the assessment of dynamic hyper inflation as we...

Страница 44: ...3 Composition of the energy metabolism The presentation of the training areas makes it possible to explain the different training areas to the test person The graph shows important parameters and the...

Страница 45: ...epresentation training plan 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 a...

Страница 46: ...CPET examination very well on the basis of the measured curve Nevertheless in individual cases it may be necessary to correct the measurements manually 3 1 4 2 1 Move Thresholds 1 Move the mouse poin...

Страница 47: ...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 the mouse to the de...

Страница 48: ...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 1 Move the mouse pointer to a line that you want to correct The cur...

Страница 49: ...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 2 Add new event For this Select the correspondi...

Страница 50: ...of the exertion criteria 2 Graphical representation of the exertion criteria 3 A green tick means that the criterion has been met A red cross means that the criterion has not been fulfilled If a cert...

Страница 51: ...bol and after selecting Accept you will return to the main view After selecting the Next button the next wizard view configured in the settings appears In this example the evaluation for AT The follow...

Страница 52: ...The following window appears for the interpretation 1 Open interpretation view For this select the button Flowchart Navigate through the tree diagram until an interpretation suggestion has been found...

Страница 53: ...r appears after selecting the Continue button or the wizard is closed 3 1 4 6 Training Planner The following window appears for creating an individual training plan Depending on the results of the CPE...

Страница 54: ...low for determination Intensive Heart rate for the intensive training phase determination see tables below Interval training Heart rate for interval training see tables below for determination Sport S...

Страница 55: ...oad at VT1 Interval training HF at 140 of load at VT1 Max HF RCP threshold model Designation Intensity Regeneration HF at start of load HF at 65 of load at VT2 Extensive HF at 65 of the load at VT2 HF...

Страница 56: ...t 82 5 of load at VT2 Extensive HF at 82 5 of the load at VT2 HF at 92 5 of the load at VT2 Intensive HF at 92 5 of load at VT2 HF at VT2 Interval training HF at VT2 Max HF Max HR Model Designation In...

Страница 57: ...can be edited by clicking in the field Changing the duration automatically recalculates the energy consumption Clicking on the Intensity field opens a window for editing the displayed text and colour...

Страница 58: ...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 r...

Страница 59: ...RPM 1 min pedal speed VO2 l min Oxygen Uptake Fex expired flow FiO2 inspired O2 concentration FeO2 expired O2 concentration FeCO2 expired CO2 concentration VO2 kg ml min kg Oxygen uptake per body wei...

Страница 60: ...Volume FEV1x35 VEpeak is Minute Ventilation at VO2max BR Breathing reserve BR MVV VEpeak MVV 100 VE VO2 Ventilatory equivalent for O2 Minute Ventilation divided by Oxygen uptake VE VCO2 Ventilatory e...

Страница 61: ...ressure PETCO2 mmHg End tidal CO2 pressure HR 1 min Heart rate HRR 1 min Heart rate reserve HRR predicted HR HR at VO2max O2Pulse ml beat O2 Pulse O2Puls VO2 x 1000 HR O2Pulse kg ml kg beat O2 Pulse p...

Страница 62: ...TCO2 pH pH blood gas value HCO3 meq l Bicarbonat blood gas value BE meq l Base Excess blood gas value Mets Metabolic equivalent Borg Borg Index Lipides mg min Lipids oxidation Glucides mg min Carbohyd...

Страница 63: ...l volume ratio VO2 Oxygen uptake in percent of VO2max PAO2 mmHg Alveolar PO2 pressure Load Ref Load in percent of reference load SpO2 Quality Quality of SpO2 reading Fat mg min Lipids oxidation CH mg...

Страница 64: ...Load i W Load interpolated over each load stage HR i 1 min HR interpolated over each load stage VO2ref l min Predicted Oxygen consumption VEref l min Predicted minute ventilation Vt VC Tidal volume in...

Страница 65: ...an l min Fan speed Load Speed Elev Parameter which will show Load if a cycle ergometer protocole is used and Speed Elevation if a treadmill protocole is used Ambient temperature C Ambient temperature...

Страница 66: ...e of predicted load at LIPOXmax HR Lipox beats min Heart rate at LIPOXmax point Lipids Lipox mg min Lipides at LIPOXmax point Load Crossing point W Load at crossing point Load Ref Crossing point Load...

Страница 67: ...2 AT Ventilatory equivalent for CO2 at anaerobic threshold HRR 1 min Heart rate reserve at VO2max PaO2 Rest mmHg Arterial oxygen partial pressure at rest P A a O2 Rest mmHg Alveolar Arterial PO2 diffe...

Страница 68: ...nsation point VO2 kg ml min kg Oxygen uptake per body weight at VO2max SBP Rest mmHg Systolic blood pressure at rest SBP mmHg Systolic blood pressure at VO2max DBP Rest mmHg Diastolic blood pressure a...

Страница 69: ...k rate Vol corr in Inspiratory corection factor for volume calibration Vol corr ex Expiratory corection factor for volume calibration O2 corr O2 correction factor determined during gas calibration CO2...

Страница 70: ...g l min Logarithm of minute ventilation Load m W Measured load Speed m km h Measured speed Elev m Measured elevation Sf 1 min Rowing frequency Rowing machine tin ttot inspiration time divided by durat...

Страница 71: ...g Tube length Adjust the length of the tube Blood pressure confir If activated the result of automatic BP measurement need to be confirmed Insp Deadspace Setting of inspiratory dead space Need to be a...

Страница 72: ...rgometers Treadmill profiles Add remove copy and configure load profiles for treadmill ergometers Treadmill start If activated a warning is displayed before starting the treadmill Using the buttons ne...

Страница 73: ...VO2 Lactate test and Lipox test Manual load change Increment for the manual change of the load during the examination Manual speed change Increment for the manual change of the speed during the exami...

Страница 74: ...to the selected load profile The following setting options are available Setting Function Phase Selection of the load phase Rest warm up load and recovery are available for selection Stage duration Du...

Страница 75: ...Phase Selection of the load phase Rest warmup load and recovery are available for selection Total duration Total duration of the ramp load Stage duration Duration of a single ramp level Start load Lo...

Страница 76: ...sting events Setting Function Trigger Set when the events are triggered There is a choice between Fix intervalls Fix timepoint and Trigger by load stage Phases Selection of the phases in which the eve...

Страница 77: ...s are available Setting Function Name Name for the reason for exercise stop Parameter Setting a parameter that is monitored for exercise stop Limit Setting the limit at which the reason for exercise s...

Страница 78: ...sed to set whether the Borg scale is indicated from 0 to 10 CR 10 from 0 with 0 5 to 10 CR 10 extended or from 6 to 20 RPE The text for the Borg scale can be changed with the help of the Setup button...

Страница 79: ...display is shown for selection during the measurement View Configuration of the screen display Parameters Configuration of the parameter display In the Display area the number and type of elements to...

Страница 80: ...as a percentage of the total width Type Selection of the element type CPET graphic Element selection The following element types are available Depending on the selected element type certain elements a...

Страница 81: ...for estimating the arterial partial pressure of carbon dioxide at the end of the load Blood gases If activated the blood gases at maximum load will be interpolated with the last values Data editor If...

Страница 82: ...t multiple entries by using the CTRL Key MaxVO2 Detection Configuration of filter settings used for VO2max detection Detection AT Configure which parameters should be displayed for the detection of th...

Страница 83: ...rameters 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 Marker or cursor settings for the graphi...

Страница 84: ...is 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 Scaling Select scaling f...

Страница 85: ...isplayed Thickness Adjusting the line thickness Ref values Setting the reference values for the selected parameter Scaling Setting the scaling Filter mode Setting the filter mode Filter depth Adjustin...

Страница 86: ...mode the following selection can be made Setting Function All data All measured data is displayed Fixed time intervals The measured values are displayed averaged according to the time interval specif...

Страница 87: ...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 following settings can be made Selection of which mark...

Страница 88: ...straight line must be flatter Calc start Calculation start of the regression as absolute value or relative to the maximum value Calc end Calculation end of the regression as absolute value or relative...

Страница 89: ...ression line 1 Max offset Maximum offset for the regression line 1 Allowed Y deviation Permissible Y deviation when calculating the regression line 5 8 CPET Filtering The filter settings can be set se...

Страница 90: ...gnation for the training ranges Min requirement Selection of the minimum requirement for using the training area The choices are None Max HR reached VT1 determined VT2 determined and VT1 and VT2 deter...

Страница 91: ...scription 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 calculation of the training range 5...

Страница 92: ...is always used Otherwise the duration is set automatically Description Description of the training session Minimal HR Setting the lower limit for the heart rate Maximal HR Setting the upper limit for...

Страница 93: ...f training days per week Weeks Selection of the lower or upper limit for the total duration of the training in weeks Duration Unit Selection of the lower or upper limit for the duration of a training...

Страница 94: ...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 re...

Страница 95: ...art graphics remain stored Check interface setting to ECG software No flow signal Check correct connection of the device Check connection between device and flow sensor Check tubes for moisture Check...

Страница 96: ...delay does not match the entered tube length Correct the set tube length Check tubes for moisture Replace filter and Permapur Check the device for faults see the IFU of the device Measurement error V...

Страница 97: ...us measurement error Check the fit of the mask noseclip Make sure that the patient tightly encloses the mouthpiece with his or her lips during the examination Check connection between device and flow...

Страница 98: ...ge 98 Version 4 Release date 01 April 2022 7 Authorised Specialist Retail Partner You can reach your responsible specialist retail partner via a contact form of the manufacturer www geratherm respirat...

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