GERATHERM CPET User manual

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!

Version: 4
Release date: 01 April 2022
Filename: TDOBCH0120R4
Language: English
Software version: 1.3.3.1
Geratherm® Respiratory GmbH
Kasernenstraße 4
97688 Bad Kissingen, GERMANY
Tel.: [phone]
Fax: [phone]
[e-mail]
www.geratherm-respiratory.com
EUDAMED SRN:
DE-MF-000006818
© Geratherm® Respiratory GmbH
0494

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 3
Table of Contents
1General information ...............................................................5
1.1 Abbreviations.................................................................................. 6
1.2 Explanations................................................................................... 6
1.3 Copyright........................................................................................ 8
1.4 Limitation of Liability ....................................................................... 8
2Safety in Handling ..................................................................9
2.2 Operation / Servicing and Maintenance ........................................ 10
3Operation .............................................................................12
3.1 CPET............................................................................................ 12
3.1.1 Software BLUE CHERRY® - Controls .......................................... 14
3.1.2 Preparation................................................................................... 16
3.1.3 Measurement ............................................................................... 18
3.1.3.1 Screen Layout During the Examination ......................................... 20
3.1.3.2 Preparation Phase........................................................................ 21
3.1.3.2.1 Device Selection........................................................................... 21
3.1.3.2.2 Selection of the 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 / Rest Phase ....................................................... 28
3.1.3.3.2 Start of the Load Phase................................................................ 29
3.1.3.3.3 Start of the Recovery Phase ......................................................... 31
3.1.3.3.4 Saving the Investigation................................................................ 32
3.1.3.4 Control Load Protocol .................................................................. 33
3.1.3.5 Events During the Investigation..................................................... 34
3.1.3.5.1 Comments ................................................................................... 34
3.1.3.5.2 Blood Gases................................................................................. 35
3.1.3.5.3 Borg ............................................................................................. 36
3.1.3.5.4 Blood Pressure............................................................................. 37
3.1.3.5.5 Edit Events ................................................................................... 38
3.1.3.5.6 Record Tidal Loops ...................................................................... 39
3.1.4 Analysis ........................................................................................ 40
3.1.4.1 Presentation of Results................................................................. 40
3.1.4.1.1 Graphical Representation ............................................................. 40
3.1.4.1.2 Threshold Table............................................................................ 41
3.1.4.1.3 Continuous Data........................................................................... 42

Instructions for Use
CPET
page 4
Version: 4 | Release date: 01 April 2022
3.1.4.1.4 Tidal Loops................................................................................... 43
3.1.4.1.5 Interpretation ................................................................................ 44
3.1.4.1.6 Training Areas .............................................................................. 44
3.1.4.1.7 Training Plan................................................................................. 45
3.1.4.2 Correction .................................................................................... 46
3.1.4.2.1 Move Thresholds .......................................................................... 46
3.1.4.2.2 Adapt Regression Lines................................................................ 47
3.1.4.2.3 Correct Tidal Loops...................................................................... 48
3.1.4.3 Events (Blood Gases, Blood Pressure, Borg)................................ 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
4Parameter Description .........................................................59
4.1 CPET............................................................................................ 59
5Settings ................................................................................71
5.1 Measurement CPET ..................................................................... 71
5.2 Load Profiles ................................................................................ 72
5.3 Exercise Stop ............................................................................... 77
5.4 Events .......................................................................................... 78
5.5 CPET Views.................................................................................. 79
5.6 Display CPET ............................................................................... 81
5.7 CPET Plots ................................................................................... 83
5.8 CPET-Filtering .............................................................................. 89
5.9 Training Ranges............................................................................ 90
5.10 Training Units ............................................................................... 91
5.11 Training Plans............................................................................... 92
6Fault Indication and Repair..................................................94
7Authorised Specialist Retail Partner ....................................98

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 5
1General information
Our medical devices are manufactured and tested in accordance
with certified quality standards. This means that the product
fulfills the regulatory requirements for medical devices.
This IFU supplements the IFU of the product with information on
examination and, according to DIN EN ISO 60601-1, is an
integral part of the product. 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.
In addition to the notes in this IFU, the local accident prevention
regulations and the national industrial safety regulations apply.
Read this IFU carefully and in its entirety before using the
product. For future reference, keep them in the immediate
vicinity of the medical device, ready to hand for the
user / operator and accessible at all times!
If, in spite of careful reading of this IFU, you require more
information, please contact your specialist retail partner on site.
You can obtain the contact details via a form provided by the
manufacturer at
www.geratherm-respiratory.com/login/.

Instructions for Use
CPET
page 6
Version: 4 | Release date: 01 April 2022
1.1 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 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 following
explanations of symbols. These are divided into hazard levels. If
several severity levels occur at the same time, the warning note
for the highest level is always used.
The safety instructions are presented in accordance with
DIN ISO 3864 following ANSI Z535.4
(American National Standards Institute).

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 7
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.
Indicates a possibly hazardous situation.
Not observing and not avoiding the situation may lead to
minor or moderate injuries.
Indicates places in the IFU which are relevant to the current
topic but do not present any danger, or which simplify your
handling of the product.
Attention
Not observing this warning information may lead to faults or
malfunctions of the product or may indicate that something in
its environment may be damaged.

Instructions for Use
CPET
page 8
Version: 4 | Release date: 01 April 2022
1.3 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.
1.4 Limitation of Liability
The manufacturer emphasises the creation of accompanying
documents for his products. Despite careful checking, errors or
inaccuracies in this document version cannot be completely
ruled out. The liability of the manufacturer for direct or indirect
damages arising in connection with the present documentation
is excluded to the extent permitted by law. Technical or content
information in this document is subject to change at any time
and without notice. Should any questions arise, please contact
your authorised specialist retailer or the manufacturer directly.

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 9
2Safety 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!

Instructions for Use
CPET
page 10
Version: 4 | Release date: 01 April 2022
2.1 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:
•Users must be familiar with the test methods
and their clinical significance!
• Only use officially trained users!
2.2 Operation / Servicing and Maintenance
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 respective
contraindications before each test
• When carrying out tests, observe the content of
the applicable guidelines and recommendations
(e.g. ATS / ERS Guidelines)!
•Make sure that the patient's nose is closed and
the mouthpiece is firmly enclosed by the mouth
(lips) respectively the face ma
sk is sitting leak tight
and firmly during the entire examination.
Reason:
Cross-contamination.
For this:
Observe the
general medical principles!
Therefore:
• Do not use single-use products more than once!

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 11
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. ECG) during exercise test!

Instructions for Use
CPET
page 12
Version: 4 | Release date: 01 April 2022
3Operation
3.1 CPET
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.
The test person is exposed to an increasing load on an
ergometer until exhaustion. Heart rate, respiratory rate, minute
ventilation, oxygen uptake and carbon dioxide output are
continuously 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 about the exercise tolerance of the cardio-respiratory
system and allow differential diagnostics.
For this purpose, a large number of parameters are calculated
from the recorded measurement data, which indicate a disease
in the case of deviations from the normal course, whereby the
transitions can be fluid:
Restrictions on ventilation (e.g. obstructive pulmonary disease,
restrictive pulmonary disease).
•VE (minute ventilation)
•Vt (tidal volume)
•Bf (respiratory rate)
Cardio-circulatory restrictions (e.g. heart failure, heart defects)
•HR (heart rate)
•O2pulse (oxygen pulse)
•VO2(oxygen uptake)
•VCO
2
(carbon dioxide output)

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 13
Restrictions of gas exchange (Diffusion/Ventilation/Perfusion)
(e.g. interstitial lung disease, pulmonary hypertension, heart
failure).
•VE/VO2(respiratory equivalent for O2)
•VE/VCO2(respiratory 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 fields according to Prof. Karlman Wasserman
(Wasserman K, Hansen J E, Sue D Y, Stringer W W, Whipp B J.
Principles of Exercise Testing and Interpretation: Including
Pathophysiology and Clinical Applications. 4th ed., Lippincott,
Williams & Wilkins 2005) established.

Instructions for Use
CPET
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Version: 4 | Release date: 01 April 2022
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
Interpret lactate values
Measurement:
Button
Function
Open measurement settings
Start measurement
Cancel measurement
Save measurement

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 15
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
and Borg
Recording breathing curves and load
For general information about operating the
BLUE CHERRY® software, please refer to the separate IFU
BLUE CHERRY®.

Instructions for Use
CPET
page 16
Version: 4 | Release date: 01 April 2022
3.1.2 Preparation
Possible danger to life.
Reason:
Cross-contamination.
For this:
Observe the
general medical principles!
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
• In the IFU of the respective device
Electrocardiography (ECG):
A detailed description for the preparation of an
electrocardiography (ECG) can be found:
•In the IFU of the ECG
Ergometer / Treadmill:
A detailed description for the preparation of the ergometer and
treadmill can be found:
•In the IFU of the ergometer
•In the IFU of the treadmill

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 17
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. 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 should breathe as evenly as possible
throughout the examination and not speak.
In order to achieve accurate results, it is important
that the patient exactly follows the instructions for
each breathing maneuver and cooperates well.
Attention
Before the measurement the patient should avoid the following:
•Alcohol
•Tobacco
• Physical stress

Instructions for Use
CPET
page 18
Version: 4 | Release date: 01 April 2022
3.1.3 Measurement
Possible danger to life.
Reason:
Misdiagnosis caused by measurement error.
Therefore:
•Make sure that the patient's nose is closed and
the mouthpiece is firmly enclosed by the mouth
(lips) respectively the face mask is sitting leak tight
and firmly during the entire examination.
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. ECG) during exercise test!
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.

Instructions for Use
CPET
Version: 4 | Release date: 01 April 2022
page 19
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
patient can already
breathe at the
sensor.
Afterwards, the
breathing signals are
automatically
synchronised.
If a flow / volume curve has not yet been recorded before the
examination, it can be recorded during preparation.
1

Instructions for Use
CPET
page 20
Version: 4 | Release date: 01 April 2022
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. 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 power perception according to Borg
(see chap. 3.1.3.5.3) can be entered. In addition, a marker for
blood gas analysis (see chap. 3.1.3.5.2) can be set for later entry
of the blood gas values or a measurement of the tidal volume
(see chap. 3.1.3.5.6) can be initiated.
1
2
3
4