GERATHERM Ergostik User manual

Ergostik
Serial numbers: xx|8|201|yyy and 2201xxxxx
Instruction for Use
Version: 7
Release date: 02. August 2021
Please read carefully and store in a place which is always accessible for future
consultation!

Version: 7
Release date: 02. August 2021
File name:TDOERG0112R7
Language:English
Affected serial numbers: xx|8|201|yyy and 2201xxxxx
Software version: valid from 1.1.0
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
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
Page 3
Table of Contents
1General Information ...............................................................6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations................................................................................... 7
1.3 Symbols ......................................................................................... 9
1.4 Copyright...................................................................................... 12
1.5 Limitation of Liability ..................................................................... 12
2Conditions of Use ................................................................13
2.1 Intended Purpose......................................................................... 13
2.1.1 Indication...................................................................................... 15
2.1.2 Contraindication and Side Effect................................................... 16
2.1.2.1 Contraindications.......................................................................... 16
2.1.2.2 Side Effects .................................................................................. 18
2.1.3 Definition of the Groups of People ................................................ 20
2.2 Intended Use................................................................................ 21
2.2.1 Original Spare Parts / Accessories / optional Expansions ............. 23
2.2.1.1 Original Spare Parts / Accessories................................................ 24
2.2.1.2 Optional Expansions..................................................................... 27
2.2.2 Consumable Items / Auxilary Materials ......................................... 32
3Safety in Handling ................................................................33
3.1 General Safety at Work and Personnel Qualification ..................... 34
3.2 The Technical State of Ergostik and System Construction............ 35
3.3 Operation / Servicing and Maintenance ........................................ 37
3.4 Electromagnetic Compatibility (EMC)............................................ 38
3.5 Cleaning and Disinfection ............................................................. 39
4Structure and General Function of Ergostik ........................41
4.1 Hardware ..................................................................................... 41
4.1.1 Overview ...................................................................................... 41
4.1.2 Connections/ Interfaces of the Ergostik ........................................ 42
4.1.2.1 Ergostik Device and Connections ................................................. 42
4.1.2.2 Sensors ........................................................................................ 43
4.1.2.3 Pressure Reducer......................................................................... 44
4.1.3 System Construction and Electrical Safety ................................... 44
4.1.3.1 Data Connection .......................................................................... 46
4.1.3.2 Equipment Cart with Isolating Transformer ................................... 46
4.1.3.3 Power Supply ............................................................................... 47
4.2 Technical Protection Measures..................................................... 47
4.3 Software....................................................................................... 47

Instructions for Use
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Version: 7 | Release date: 02. August 2021
5Transport, Storage and Assembly .......................................49
5.1 Transport to the Location of Use .................................................. 49
5.2 Storage ........................................................................................ 49
5.3 Assembly...................................................................................... 50
6Operation .............................................................................51
6.1 Initial Operating............................................................................. 51
6.2 Recommissioning after Servicing / Cleaning Work ........................ 51
6.2.1 Assembly Calibration Tube ........................................................... 52
6.2.2 Power Supply and PC-Connection............................................... 54
7Operating Instructions .........................................................55
7.1 Checking for Worn Parts .............................................................. 55
7.1.1 Minifilter / Permapure Check ........................................................ 55
7.2 Establishing Operational Readiness .............................................. 56
7.3 Switching Ergostik On / Off .......................................................... 56
7.4 Inserting the Flow Sensor ............................................................. 57
7.4.1Assembly Face Mask.................................................................... 58
7.4.2 Assembly Silicone Mouthpiece ..................................................... 59
7.5 Calibrating Ergostik ...................................................................... 60
7.6 Using Ergostik / Performing Measurements.................................. 60
7.7 Exchange of Disposable Products / Disinfection........................... 62
7.7.1 Noseclip ....................................................................................... 62
7.7.2 Ergoflow / Mask / Mouthpiece...................................................... 63
8Servicing / Maintenance ......................................................64
8.1 Duties of the Responsible Organisation ........................................ 64
8.2 Servicing / Maintenance by the User / Operator ........................... 65
8.2.1 Checking / Exchanging of Tubes and Cables ............................... 66
9Cleaning and Disinfection ....................................................67
9.1 Single Use .................................................................................... 68
9.2 Disinfection................................................................................... 68
9.2.1 Ergostik ........................................................................................ 71
9.2.2 Flow Sensor- / Ergoclip Removal.................................................. 71
9.2.3 Removing the Silicone Mask / Adapter ......................................... 73
10 Fault Indication and Repair..................................................74
11 Decommissioning / Disposal ...............................................77
11.1 Expected Service Life ................................................................... 77
11.2 Decommissioning ......................................................................... 77
11.3 Disposal ....................................................................................... 77

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11.3.1 Transport Packaging .................................................................... 77
11.3.2 Ergostik ........................................................................................ 77
11.3.3 Infectious / Contaminated Single Use Items ................................. 78
12 Technical Specifications ......................................................79
12.1 Technical Data.............................................................................. 79
12.2 Installation and Operating Conditions ........................................... 81
12.3 Electrical Safety Concept.............................................................. 82
12.3.1 Ergostik with Medical Device Cart and Isolation Transformer ........ 82
12.3.2 Ergostik without Medical Device Cart and without Isolation
Transformer.................................................................................. 83
12.4 Electromagnetic Compatibility / EMC Guidelines .......................... 84
12.4.1 Emitted Interference Guideline and Manufacturer Declaration....... 84
12.4.2 Interference Resistance for all ME Systems Guideline and
Manufacturer Declaration ............................................................. 85
12.4.3 Interference Resistance for None-Life-Supporting ME Systems
Guideline and Manufacturer Declaration ....................................... 86
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME
Systems ....................................................................................... 88
13 Safety of Product and Material ............................................89
14 Product Labeling / Type Label.............................................90
15 Warranty and Service...........................................................91
15.1 General Conditions....................................................................... 91
15.2 Warranty Exemption ..................................................................... 91
15.3 Packaging and Shipping............................................................... 92
16 Authorised Specialist Retail Partner ....................................93
Attachment – Declaration of Conformity..............................94

Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
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Version: 7 | Release date: 02. August 2021
Foreword
Thank you for purchasing a medical device from Geratherm®
Respiratory GmbH. Ergostik is part of our product family with
solutions for cardiopulmonary function diagnostics which are
operated using the common software platform
BLUE CHERRY®. This means that you have the option of
optimising the working processes in your practice using the
networked application of further products from Geratherm®
Respiratory GmbH, and to benefit from the simple use of our
products.
1General Information
All our medical devices are manufactured and tested in
accordance with certified quality standards. This means that
Ergostik fulfills the regulatory requirements for medical devices
(class IIa).
This IFU is a component of the product in accordance with DIN
EN ISO 60601-1. It should make it easier to familiarise yourself
with Ergostik, as well as give you instructions about its intended
use and safe operation.
This IFU has been written for healthcare professionals who are
qualified to perform cardiopulmonary exercise tests.
The basic prerequisite for safe working with the Ergostik 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
Ergostik. For future reference, keep them in the immediate
vicinity of the medical device, ready at hand for the user /
operator and accessible at all times!

Instructions for Use
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Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
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Please refer to the separate IFU of the BLUE CHERRY®
software platform for pulmonary function diagnostics.
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/.
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
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Version: 7 | Release date: 02. August 2021
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 Ergostik.
Attention
Not observing this warning information may lead to faults or
malfunctions of the Ergostik or may indicate that something in
its environment may be damaged.

Instructions for Use
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Version: 7 | Release date: 02. August 2021
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1.3 Symbols
Symbols displayed in this IFU, on the medical device itself and/or
on its packaging are standardised symbols.
Symbol Explanation
Follow the instructions for use!
Applied part from type BF corresponding to
DIN EN 60601-1
The applied part is in direct contact with the patient
(BF: Body Floating). In order to comply with the limit
value for the patient leakage current, the applied part is
insulated from earth.
Device of protection class II
(safety measure against touching)
Protection by double or reinforced insulation
For the prevention of electric shock.
Only use indoors!
IP20
Protection type (safe environmental conditions)
IP2x: Protection of enclosure against ingress of solid
foreign objects with a diameter greater than or equal to
12.5 mm and access to hazardous parts with finger.
IPx0: No protection of enclosure against harmful ingress
of water.

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Version: 7 | Release date: 02. August 2021
Symbol Explanation
Do not dispose of the device along with general
household waste!
It must be disposed of in a proper and correct manner
via the distributor. By marking a device with this symbol,
the manufacturer also declares that he fulfills all the
requirements of the law on the distribution, return and
environmentally friendly disposal of electrical and
electronic devices. (Rechargeable) batteries must be
taken to a central collection point for used batteries or to
the manufacturer.
For single use only!
This symbol does not refer to the Ergostik itself, but to
the consumable items used in connection with it.
This is applied to the respective packaging and must be
observed.
Batch number
This symbol identifies the batch or lot code given by the
manufacturer. The code is placed adjacent to the
symbol.
Serial number
This symbol identifies the serial number given by the
manufacturer.
Catalog number
This symbol identifies the catalog number given by the
manufacturer.
Manufacturer
This symbol identifies the manufacturer of a product.
Date of manufacture
This symbol indicates the date on which a product is
manufactured.

Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
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Symbol Explanation
0494
Conformity mark
This symbol indicates conformity with health, safety and
environmental protection standards for products sold
within the European Economic Area (EEA). The
additional four-digit number identifies the Notified Body
involved in the conformity evaluation procedure of this
product. In this case 0494 identifies SLG Prüf- und
Zertifizierungs GmbH as Notified Body.
Caution, non-ionizing electromagnetic radiation
Precautions must be taken to avoid an unexpected
effect of non-ionizing radiation.
Fragile, handle with care
The package contains a product that must be handled
with appropriate care to prevent damage during
transport and storage.
Keep away from rain
The package contains a product that must be protected
from moisture during transport and storage.
Temperature limitation
The product can be safely transported, stored or
operated within the specified temperature range.
Humidity limitation
The product can be safely transported, stored or
operated within the specified humidity range.
Atmospheric pressure limitation
The product can be safely transported, stored or
operated within the permissible atmospheric pressure.

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Version: 7 | Release date: 02. August 2021
1.4 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.
1.5 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
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Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
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2Conditions of Use
Any other use of Ergostik which is not described in this IFU is
deemed improper use. The responsible organisation of
Ergostik alone is liable for any direct or indirect damage
resulting from not adhering to these conditions.
They are then solely responsible for the fulfillment of the basic
requirements of the medical device and assumes complete
product liability for the whole system.
2.1 Intended Purpose
The medical device Ergostik is a PC-based measuring device
used to determine physical ability by measuring gas exchange.
The examination involves an analysis of the interplay between a
patient’s heart, circulatory system, breathing and metabolism
whilst their body is being put under a defined load. The test
subject is put under load whilst on an ergometer. Their heart
rate, breathing rate, respiratory minute volume, oxygen intake
and carbon dioxide output is continually recorded throughout the
process.
The Ergostik consists of a case with integrated electronics used
to determine ventilation, as well as to analyze oxygen and
carbon dioxide levels. It is connected to a computer via an
integrated USB interface. A 12 V power supply is used. The tried
and tested Ergoflow flow sensor is used to measure flow.
The measurement device is supplied with BLUE CHERRY®
software. The standard version contains CPET, spirometry and
flow / volume measurements, as well as pre / post examinations
and trend analysis. The software contains a database for patient
information and measurement results. The modular design of
both software and hardware allows additional measurement
options to be incorporated, such as MVV or SPO2.

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Examination Required option
Bronchoprovokation
Provokation ( 403680)
Resting Energy Expenditure /
Resting Metabolic Rate
REE ( 526143)
You can find more information in:
•IFU Spirometry
for carrying out the examination
•IFU BLUE CHERRY®
for the general operation of the software and carrying
out the examination

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2.1.1 Indication
The Ergostik can be used for cardio-pulmonary (exercise) tests
for diagnosis, follow-up, screening and severity assessment of
pulmonary diseases. These include in particular:
Evaluation of exercise intolerance
Unexplained dyspnea
Evaluation of patients with cardiovascular diseases
Evaluation of patients with respiratory diseases
•Chronic obstructive pulmonary disease
•Interstitial lung disease
•Chronic pulmonary vascular disease
•Cystic fibrosis
•Exercise-induced bronchospasm
Preoperative assessment
•Preoperative assessment for lung cancer resection
surgery
•Surgery to reduce lung volume
•Evaluation for lung or heart-lung transplantation
•Preoperative evaluation of other procedures
•Prescription of pulmonary rehabilitation exercises
Prescription of pulmonary rehabilitation exercises
Assessment of the impairment / disability

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2.1.2 Contraindication and Side Effect
2.1.2.1 Contraindications
The following contraindications apply to ergometric
examinations:
Contraindications Absolute Relative
Acute myocardial infarction (3–5 days)
X
Unstable angina
X
Uncontrolled arrhythmias
X
Syncope
X
Active endocarditis
X
Acute myocarditis or pericarditis
X
Symptomatic severe aortic stenosis
X
Uncontrolled heart failure
X
Acute pulmonary embolus or pulmonary infarction
X
Thrombosis of lower extremities
X
Suspected dissecting aneurysm
X
Uncontrolled asthma
X
Pulmonary edema
X
Respiratory failure
X
Room air desaturation at rest <= 85 %
X
Acute noncardiopulmonary disorder that may affect
exercise performance or be aggravated by exercise
X
Mental impairment leading to inability to cooperate
X X
Left main coronary stenosis or its equivalent
X
Moderate stenotic valvular heart disease
X
Severe untreated arterial hypertension at rest
(200 mm Hg systolic, 120 mm Hg diastolic)
X
Tachyarrhythmias or bradyarrhythmias
X

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High-degree atrioventricular block
X
Hypertrophic cardiomyopathy
X
Significant pulmonary hypertension
X
Advanced or complicated pregnancy
X
Electrolyte abnormalities
X
Orthopedic impairment that compromises exercise
performance
X
As the transitions between absolute and relative
contraindication can be fluid in the
assessment, the assertion of
a physician should be regarded as binding.
(Source: American Thoracic Society, American College of Chest Physicians.
ATS/ACCP Statement on cardiopulmonary exercise testing. 2003. Am J Respir
Crit Care Med. 167:211–277.)

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2.1.2.2 Side Effects
If there are no contraindications and the examination is carried
out in accordance with the descriptions in the IFU, cardio-
pulmonary exercise testing is a safe examination, but in rare
cases (1 per 10,000 examinations) serious cardiac incidents and
death (2-5 per 100,000 examinations) can occur. Therefore, the
following safety measures must be observed when conducting
cardio-pulmonary exercise tests:
•Presence of a physician for timely detection and
assessment of termination criteria (see table below)
•Presence of emergency equipment (defibrillator,
emergency medication)
•Availability of emergency medically trained personnel for
assistance
The following side effects may also occur:
Side effect / Frequency Rules of conduct
Exhaustion / Frequent
Stopping the exercise after medical
assessment.
Shortness of breath /
Frequent
Stopping the exercise after medical
assessment.
Chest pain / Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac events and, if necessary, treatment of
these.
Cardiac arrhythmias /
Frequent
Stopping the exercise after medical
assessment, monitoring of the patient for
cardiac incidents and treatment of these if
necessary.
Bronchospasm / Rare
Stopping the exercise after medical
assessment, monitoring of the patient after the
examination and administration of a
bronchodilator if necessary.

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Version: 7 | Release date: 02. August 2021
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Syncope / Rare
Treatment and initiation of emergency medical
measures if necessary.
Cancellation Criterion
Absolute Relative
ST-Depression ≥ 3 mm
X
ST-Elevation ≥ 1 mm
X
Blood pressure drop > 10 mmHg (compared to initial
blood pressure) with signs of myocardial ischemia
(angina pectoris, ST Depression)
X
Moderately severe angina pectoris symptoms
X
Severe dyspnoea
X
Clinical signs of low perfusion (cyanosis)
X
Persistent (duration > 30 sec.) ventricular tachycardia
X
Exhaustion of the patient
X
Technical problems (defective ECG registration...)
X
Hypertensive dysregulation (Rrsyst 230-260 mmHg,
Rrdiast ≥ 115 mmHg)
X
Blood pressure decrease > 10 mmHg (compared to
the initial blood pressure) without signs of myocardial
ischemia (no angina pectoris, no ST depression)
X
Polymorphic extrasystole, pairs (2 consecutive VES),
volleys (≥ 3 consecutive VES)
X
Supraventicular tachycardia
X
Bradyarrhythmias
X
Conduction Disorders
X
Occurrence of conduction disorders (higher grade AV
block, thigh block)
X
Increased angina pectoris symptoms
X

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As the transitions between absolute and relative
contraindication can be fluid in the
assessment, the assertion of
a physician should be regarded as binding.
(Source: Deutsche Gesellschaft für Kardiologie. 2000. Leitlinien zur Ergometrie.
Z Kardiol. 89:821–837.)
2.1.3 Definition of the Groups of People
Groups of people named in this IFU are defined as follows:
Manufacturer
specifies all measures to ensure the safe and proper handling
and application of Ergostik. They are responsible for instructing
the operator in relation to this via the corresponding specialist
retail partner.
Responsible Organisation
is any natural or legal person who is responsible for the
operation of the health institution where Ergostik is used by their
employees (users).
User
is a medically trained specialist who is familiar with cardio-
pulmonary exercise tests, who uses Ergostik on the patient after
verifiable instruction by the responsible organisation and / or is
responsible for rectifying faults to the Ergostik, as well as its
calibration.
Users must be aware of the clinical meaning and, for example,
be a physician, physician’s assistant, assistant or trained
maintenance personnel with basic electrical or mechanical
training. The user is able to identify, assess and, in the best
case, to avoid possible hazards when using Ergostik.
Trainee medical specialists must also be supervised in addition
to receiving training in how to use Ergostik.
Operator
is a person who has received instruction on cleaning Ergostik by
a medically trained specialist.