Manual Ergostik

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.: +49 971 7857043-0
Fax: +49 971 7857043-30
info@geratherm-respiratory.com
0494 www.geratherm-respiratory.com
EUDAMED SRN:
DE-MF-000006818 © Geratherm® Respiratory GmbH
Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Table of Contents
1 General Information ............................................................... 6
1.1 Abbreviations.................................................................................. 7
1.2 Explanations ................................................................................... 7
1.3 Symbols ......................................................................................... 9
1.4 Copyright...................................................................................... 12
1.5 Limitation of Liability ..................................................................... 12
2 Conditions 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
3 Safety 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
4 Structure 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
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Ergostik
5 Transport, Storage and Assembly ....................................... 49

5.1 Transport to the Location of Use .................................................. 49
5.2 Storage ........................................................................................ 49
5.3 Assembly ...................................................................................... 50
6 Operation ............................................................................. 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
7 Operating 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
7.4.1 Assembly 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
8 Servicing / 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
9 Cleaning 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

Ergostik
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.
1 General 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!

Ergostik
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).

Ergostik
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.
Not observing this warning information may lead to faults or

malfunctions of the Ergostik or may indicate that something in
Attention its environment may be damaged.
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.

Ergostik
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.

Ergostik
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.

Ergostik
Symbol Explanation
Conformity mark
This symbol indicates conformity with health, safety and
environmental protection standards for products sold
0494 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
operated within the specified humidity range.
Atmospheric pressure limitation

operated within the permissible atmospheric pressure.

Ergostik
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.

Ergostik
2 Conditions 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.

Ergostik
Examination Required option

Bronchoprovokation Provokation ( 403680)
Resting Energy Expenditure / REE ( 526143)
Resting Metabolic Rate
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

Ergostik
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

Ergostik
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
X
exercise performance or be aggravated by exercise
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
X
(200 mm Hg systolic, 120 mm Hg diastolic)
Tachyarrhythmias or bradyarrhythmias X

Ergostik
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
X
performance
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.)

Ergostik
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 / Stopping the exercise after medical
Frequent 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 / Stopping the exercise after medical
Frequent 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.

Ergostik
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 X
(angina pectoris, ST Depression)
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,
X
Rrdiast ≥ 115 mmHg)
Blood pressure decrease > 10 mmHg (compared to
the initial blood pressure) without signs of myocardial X
ischemia (no angina pectoris, no ST depression)
Polymorphic extrasystole, pairs (2 consecutive VES),
X
volleys (≥ 3 consecutive VES)
Supraventicular tachycardia X
Bradyarrhythmias X
Conduction Disorders X
Occurrence of conduction disorders (higher grade AV
X
block, thigh block)
Increased angina pectoris symptoms X

Ergostik
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.

Ergostik
Patient
is a person undergoing medical treatment (check-up, initial
diagnosis as well as progress / treatment monitoring) to assess
their pulmonary exercise tolerance. The persons can be adults
without an age limitation as well as children form 4 years of age.
A requirement for carrying out the examination is the ability to
follow the instructions of the user.
2.2 Intended Use
Ergostik can be operated independently as a non-stationary

device or in combination with all other Geratherm® Respiratory
GmbH products via the universal software BLUE CHERRY®.
(see chap. 4.1.3 “System Construction and Electrical Safety”).
In all cases, the Ergostik is only intended for use in closed,
pleasantly temperature-controlled (19 °C – 25 °C) rooms in a
clinical area.
In the respective room, there must be neither flammable or
explosive gases, nor magnetic fields (e.g. MRI).
The following applies in general: The installation of Ergostik is
only deemed safe and in line with intended use when this is
carried out in accordance with the details in
chap. 12.2 “Installation and Operating Conditions”.
The responsible organisation must ensure that only medically
trained specialist personnel (see chap. 2.1.3 “Definition of the
Groups of People”) operates Ergostik. Personnel must
demonstrably have been given training in the function of
Ergostik. This also includes a complete study of this IFU.
The manufacturer has determined the expected service life (see
chap. 11.1 "Expected Service Life") and the maintenance work
required for this (see chap. 8 "Servicing / Maintenance").
The Ergostik may only be used for the duration of its service life if
the specifications are observed.
Any changes to Ergostik, in particular unauthorised
modifications, are prohibited.

Ergostik
The Ergostik is not intended for the control of vital physiological

parameters where the nature of the change could lead to
immediate danger to the patient, e.g. changes in heart function,
respiration or central nervous system activity.
Any other than the described use is deemed improper use.
The responsible organisation of Ergostik alone is liable for any
damage resulting from not adhering to these conditions.
Intended use also includes complying with all further information
and instructions in this IFU, without exception.
Electromagnetic compatibility (EMC) in accordance with

DIN EN 60601-1-2:2006-10; VDE 0750-1-2:2006-10; IEC 60601-1-
2:2001 + A1:2004. See chap. 12.4 “Electromagnetic Compatibility /
EMC Guidelines”. Ergostik is suitable for use in all institutions including
Attention those in residential areas and those which are directly connected to
the public supply network which also supplies buildings used for
residential purposes.

Ergostik
2.2.1 Original Spare Parts / Accessories / optional Expansions
Intended use also includes using prescribed original spare parts,

accessories and expansions in constructing the system.
Only the components stated in the following are deemed tested
and approved, as products by the manufacturer of Ergostik.
The installation or use of other products can, under certain
circumstances, negatively change constructive prescribed
properties of Ergostik and, in the worst case, impair the safety of
the patient, operator and / or third parties.
The manufacturer assumes no liability for such consequences.
All warranty claims shall expire.
Possible danger to life.

Reason: Cross contamination. Therefore:
• Ensure that the used components are
undamaged and that you are working in a careful
way!
• Do not use consumable articles with a limited life
span after their use-by date has been expired!
Possible physical injury.
Reason: Device damage as well as impurities /
contamination due to improper handling of
components. Therefore:
• Protect separately stored components,
accessories and consumable items from
unauthorised access!
• Observe the storage conditions stipulated by the
manufacturer!

Ergostik
2.2.1.1 Original Spare Parts / Accessories
The following components can be purchased via specialist retail

partners.
You will find:

• A list of specialist retail partners as an insert in this IFU
or in your medical device book, as well as the most
updated version at
www.geratherm-respiratory.com/login/
• Instructions on safe system construction
in chap. 4.1.3 of this IFU
• Further information about Ambistik in the separate IFU
Ambistik
Component Description / name Supply

scope in
units
Ergostik 01 979119
[old:40.400]
 Cardiopulmonary exercise
system for accurate
measurement of flow, O2
and CO2.
 USB 2.0 based desktop
device.
BLUE CHERRY® CD 01 598197
 Installation CD for intuitive [old:10.500]
Windows based
diagnostic software
platform BLUE
CHERRY®.
Ergoflow 03 139094
 Re-useable lightweight [old:10.600]
Flow Sensor for use with

Ergostik, PFTstik,
Bodystik and Diffustik
device.

Ergostik

scope in
units
Silicon Mouthpiece 01 275865
 Silicon rubber bite [old:10.816]
mouthpiece for use with
Ergoflow sensors.
Softclip 03 787158
 Disposable [old:10.200]
noseclip for lung

function tests.
 Made of soft, skin-friendly
foam for best wearing
comfort
 One size
Exercise Tube Set 02 830971
incl. Ergoclip, 2 m [old:40.424]
 Flow and gas connection

Tube set with permapure
tube for moisture
equilibration, hydrophobic
minifilter and Ergoclip
adapter for Ergoflow.
Calibration Tube 01 862229
 Tube 1,5 m with black [old:40.421]
Luer connector for gas
calibration of Ergostik.
 Outer diameter 4 mm.
Power Supply, 12 V 01 628020
 Medical grade 12 V [old:10.841]
power supply.

Ergostik

scope in
units
Power Cord, CEE 7/16, C7 01 142297
(IEC 60320, EU) [old:10.838]
 Power cord with
European plug for use
with power supply (12 V).
USB-Connection Cable, 01 362803
1.8 m [old:10.820]
 USB-connection cable
(male A and male B) to
connect USB based
devices to PC.
Silicon Adapter, Small 01 919774
28 mm x 2 mm x 50 mm [old:10.831]
 Silicon adapter size small
used for Ergoflow,
PFTstik, Bodystik and
Diffustik to connect to
calibration syringe.
Ambistik 01 634247
 USB 2.0 Ambient [old:40.300]
conditions module for
accurate online BTPS
conditions.
 Continuous measurement
of ambient temperature,
pressure and humidity.
 Runs on Windows based
diagnostic software
platform
BLUE CHERRY®.

Ergostik
2.2.1.2 Optional Expansions
The following add-ons can be purchased via specialist retail

partners.
You will find:

• A list of specialist retail partners as an insert in this IFU
or in your medical device book, as well as the most
updated version at
• Instructions on safe system construction in
chap. 4.1.3 of this IFU
• Further information about Ambistik in the separate IFU
“Ambistik”
Component Description / name
Exercise Cart 445929

 Base frame, drawer block, [old:10.900]
1 storage shelf, 2 monitor holder,
2 Liter gas bottle holder and
1 Universal bottom storage shelf incl.
safety transformer and multiple
sockets.
Calibration Syringe 608220

 Precision calibration instrument for [old:10.801]
calibration of flow or volume based
systems.
 3 Liter volume (nonadjustable).
 Comes together with adapter for
Spiraflow, Ergoflow and Blueflow.

Ergostik
Pressure Regulator, Calibration Gas 940288

(DEU) [old:10.821]
 Pressure regulator for exercise gas

calibration, providing a fixed flow of
2 l/min.
 For bottles with connector
DIN 477-1:1990 No. 14.
(External thread, Left-hand thread,
M 19 x 1.5)
Pressure Regulator, Calibration Gas 623668
(CHE/FRA) [old:10.823]
 Pressure regulator for exercise gas
calibration, providing a fixed flow of
2 liter / min.
 For bottles with connector
DIN 477-1:1990 No. 6.
(External thread, right-hand thread,
W 21.80 x 1/14”)
Accessory Pack for Ergostik 852153
Standard accessory pack containing: [old:10.904]
 2 x Exercise mask, (S and XS)
 2 x Headgear, (M and S)
 2 x Exercise mask adapter
Exercise Mask (Petite, XS, S, M and L) (Petite) 716281
 Blue silicon rubber exercise mask with [old: 10.825]
(XS) 378734
anatomically shaped design for leak [old: 10.811]
free comfortable fit. (S) 804885
 Five sizes available. [old: 10.810]
(M) 695262
[old: 10.814]
(L) 282025
[old: 10.813]

Ergostik
Exercise Mask, Pediatric (S) 838093

 Translucent silicon rubber exercise [old: 10.827]
(L) 220830
mask for children and adolescents. [old: 10.828]
Two sizes available.
Headgear Small for Exercise Mask (XS) 380816

 Soft headgear to fix exercise mask [old: 10.829]
(S,M) 144381
sizes petite and XS. [old: 10.812]
(L) 477893
[old: 10.834]
Headgear Pediatric for Exercise Mask 594009

 Soft headgear to fix exercise mask [old:10.826]
pediatric sizes S and L.
Exercise Mask Adapter 135248

 Adapter to fit Ergoflow sensor to [old:10.815]
exercise mask.
Silicon Mouthpiece with Saliva Trap 258832

 Silicon rubber bite mouthpiece [old:10.819]
including saliva trap for use with
Ergoflow sensors.
Pulstik 493419
 USB 2.0 receiver for heart rate from [old:40.449]
Polar® Transmitter. Runs on Windows
based diagnostic software platform
BLUE CHERRY®.
Polar® Soft Strap 860695
[old:10.809-01]
 Polar® Soft Strap belt including
electrodes.

Ergostik
Polar® H3 Heart Rate Sensor 187078

[old:10.809]
 Polar® H3 Heart Rate Sensor to
measure heart rate and transmit to
Pulstik.
WristOx2® Model 3150 with BLE 816016

 Wireless Bluetooth low energy pulse [old:10.882]
oximeter providing measurement of
oxygen saturation and pulse rate,
including strap, Bluetooth USB adapter
and batteries.
WristOx2® Model 3150 Activation Key 220553
 Activation Key for the use of the [old:10.532]
WristOx2® Model 3150 with Bluetooth.
Soft Finger Sensor 318808
 Soft finger sensor for WristOx2® Model [old:10.877]
3150.
Ear Sensor 291945

 Ear sensor for WristOx2® Model 3150 [old:10.878]
including 16 to 9 adapter cable.
Forehead Sensor 269627

 Forehead sensor for WristOx2® Model [old:10.879]
3150 including 16 to 9 adapter cable
and mounting kit (10 units).
CO2stik 197357
 USB 2.0 module for continuous [old:40.448]
correction of ambient CO2.
 Measurement range
0 – 2000 ppm CO2.
 Runs on Windows based diagnostic
software platform BLUE CHERRY®.

Ergostik
Software option: BGA-Interface 131393

 Imports results from blood gas [old:10.534]
analyzers via ASTM or HL7.
Software option: REE Software 526143

 Software option for BLUE CHERRY® [old:10.521]
to measure resting energy expenditure
(Resting Metabolic Rate).
 Automatic detection an evaluation of
plateau phase data.
Software option: Training Planer Software 551941
to create individual exercise training
plans based on the results of a CPET
test.
Software option: Lactate Software 119616
to interface with existing Ergonizer
lactate software to synchronise lactate
results.
Software option: WINLactat Software 508249
to interface with existing Winlactat

software to synchronise lactate results.
Software option: LIPOXmax Software 348061
to calculate LIPOXmax (point of
maximal fat consumtion) based on the
results of a CPET test.

Ergostik
2.2.2 Consumable Items / Auxilary Materials
The following items were tested by the manufacturer for

Ergostik. The use of other consumable items as well as auxiliary
materials with different properties is deemed improper use.
You will find a list of specialist retail partners as an insert in this

IFU or in your medical device book, as well as the most
updated version at
Komponente Description / name
Softclip 787158
 Disposable noseclip for lung [old:10.200]
function tests.
 Made of soft, skin-friendly foam for best
wearing comfort
 One size
CPET Oxygen Sensor II 318415
 Oxygen (O2) measurement cell with fast [old:40.404]
response time.
 Measurement range 0 – 100 % O2.
for wipe disinfection, alcoholic quick-acting
 Bacillol Tissues (BODE Chemie GmbH)
 SprayIn (Dr. Deppe GmbH)
for disinfection bath
with low chloride concentration
 InstruPlus (Dr. Deppe GmbH) depend-ing
Disinfectant  Bomix Plus (BODE Chemie GmbH) on provider
 Desinfektion N (ANTISEPTICA Dr.
Hans-Joachim Molitor GmbH)
 Gigasept Pearls (Schülke & Mayr
GmbH)
 Milton liquid disinfectant (Milton
Pharmaceutical UK Limited)

Ergostik
3 Safety in Handling
Ergostik has been designed and built in accordance with the

state of technology and its recognised safety and technical
regulations.
In spite of this, dangers of injury to operators / users, patients
and third parties as well as damage to Ergostik or other materials
may occur if this is:
• Not used in accordance with the conditions of intended
use.
• Not operated in a technically flawless state.
• Operated by untrained or uninstructed personnel.
• Maintained or serviced improperly.
In order for Ergostik or the total system to be operated in

accordance with its intended use, the safety information
and procedures in this IFU 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
using the Ergostik. 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!

Ergostik
3.1 General Safety at Work and Personnel Qualification

Reason: Not complying with health and safety
regulations. Ignoring essential preventive measures.
Therefore:
• Always comply with general national regulations
on accident prevention! Instruct users / operators
accordingly!
• Safety and warning information on Ergostik may
not be altered or removed! Have missing or not
readable information replaced immediately!
• When working with auxiliary materials, always
observe the safety information from the respective
manufacturer! Wear suitable protective clothing!
Reason: Electric shock. False diagnosis. Ignoring
contraindications. Triggering malfunctions of Ergostik.
Unqualified user/ operator can detect sources of
failures too late or even cause them. Therefore:
• Only use officially trained users!
• Users must be familiar with the test methods and
their clinical significance!
• All maintenance and servicing work may only be
performed by specialised personnel who have
been authorised by the manufacturer!

Ergostik
3.2 The Technical State of Ergostik and System Construction

Reason: Electric shock. Cross-contamination.
Misdiagnosis caused by measurement error.
Therefore:
• Do not overstress Ergostik! Use with care!
• Do not modify or use product Ergostik or total
system contrary to the respective manufacturer's
specification!
• Only use Ergostik within its expected service life,
determined by the manufacturer!
• Under no circumstances use or connect any
devices, systems, equipment and other products
that are not part of the total system!
• Never obstruct the access to the mains plug or
On / Off switch of the equipment cart!
Disconnection of the power supply must be easily
accessible!
• Only use accessories and consumables which are
authorised by the manufacturer as well as
authorised replacement components, add-ons
and auxiliary materials.
Check that the components are in a functional
and safe condition!
• Ensure that in the patient environment – a
distance of 1.5 meters to the patient – there are
no accessible electrical parts (interfaces, plugs,
etc.) that are not isolated from the mains with an
isolation voltage of 4 kV!
• Ensure that the users or third party persons do
not touch the patient and any conductive
connections or parts of the device that are
located outside the patient environment at the
same time!

Ergostik
• Ensure that the Ergostik cannot fall down!

Otherwise, the functionality must be checked
properly before putting it into operation!
Reason: Electrical shock and / or misdiagnosis due to
loss of electrical safety caused by exceeding the
recommended maintenance schedule. Therefore:
• Regularly check the specified maintenance

schedules!
• If a maintenance schedule is exceeded, do not
continue to use the total system!
• Request maintenance work from your authorised
specialist retail partner!
• Only use accessories and consumables which are
authorised by the manufacturer as well as
authorised replacement components, add-ons
and auxiliary materials! Check that the
components are in a functional and safe
condition!

Ergostik
3.3 Operation / Servicing and Maintenance
Danger to life.
Reason: Electric shock. Explosion. Device damage.
Unpredictable movement of metal parts.
For this: Comply with the required installation and
operating conditions! Therefore:
• In principle, observe chap. 12
“Technical Specifications"!
• Do not operate Ergostik if there are flammable or
explosive gases in the room!
• Do not operate Ergostik near the magnetic field of
an MRT system!
Reason: Electrical shock. Cross-contamination or
measurement error. For this: Ensure that the used
components are undamaged and that you are working
in a careful way! Therefore:
• Ensure that the used components are
undamaged and that you are working in a careful
way!
• Do not use consumable articles with a limited life
span after their use-by date has been expired!
• Prior to each use, visually inspect the total system

(housing, cables, connectors, tubings, pneumatic
connections, etc.) for any damages!
• If there are any damages, do not operate the
system! The damaged parts must be replaced or
repaired properly!
• Calibrate Ergostik at the intervals stated!

Ergostik
Reason: Disregard of a contraindication.

Misdiagnosis due to measurement errors. For this:
Observe 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)!
• Do not use single use products more than once!
3.4 Electromagnetic Compatibility (EMC)

Reason: Misdiagnosis due to measurement error
caused by a system failure due to uncontrollable
electromagnetic fields of inadmissible transmitting
devices. Therefore:
• While using Ergostik, do not use any transmitting
devices (e.g. mobile phones, portable phones,
power lines …) that exceed the immunity levels as
specified in the EMC guidelines!
• Ask your authorised specialist retail partner!
• No stacking of devices on top of each other and
no close arrangement. Observe the installation
and operating conditions from the manufacturer!
• Check the correct function of the Ergostik!

Ergostik
3.5 Cleaning and Disinfection

Reason: Coss-contamination. For this: Observe
general medical principles! Therefore:
• Clean and disinfect Ergostik and its reusable
components as instructed by the manufacturer
at regular intervals as specified!
Possible severe physical injury.
Reason: Contamination with transferable germs during
improper disposal. Therefore:
• Dispose single use items (disposable flow
sensors, mouthpieces and noseclips) after each
use. For this observe the applicable regulatory
requirements for biologically hazardous
materials!
• Observe regulations on wearing personal

protective equipment (PPE)!
Reason: Misinterpretation of obvious measuring errors
(drift) caused by liquid in the tubes. Therefore:
• Clean tubes only externally!
• Replace dirty tubes!

Ergostik
Ergostik could be damaged.

Reason: Penetrating liquids into electronic components.
Therefore:
• Disconnect the Ergostik from the power supply before
cleaning and disinfecting!
• (When switching off via the On / Off switch of the
Achtung equipment cart), shut down the PC completely before
doing so!
• Wipe off remaining moisture with a dry cloth!
Reason: Damaged connections. Therefore:
• To disconnect electrical connections, always pull the
plug and never the cable!

Ergostik
4 Structure and General Function of Ergostik

4.1 Hardware
4.1.1 Overview
1
3
5 6 4
[1] Ergostik
[2] Medical power supply unit (see also chap. 4.1.3)
[3] Exercise tube set
[4] Ergoflow flow sensor (see also chap. 7.4)
[5] Ambistik
[6] Type label on the bottom of the case (see also chap. 14)
[7] Type label on the bottom of the Ambistik (see also chap. 14)

Ergostik
4.1.2 Connections/ Interfaces of the Ergostik

4.1.2.1 Ergostik Device and Connections
Device front view
Flow - Connection
Flow + Connection
Gas-Connection
LED
to show the power supply
Device rear view
Power-LED
Calibration gas connection
12 V DC Power supply unit

connection
On-/ Off switch

Multisocket for connecting
accessories
Gas outlet
USB-Connection

Ergostik
4.1.2.2 Sensors
Ergostik could be damaged

Reason: Sensors are precise and high-resolution
components.
For this: Ensure the respective functions are preserved!
Attention Therefore:
• Exactly follow instructions for cleaning, disinfection and
calibration!
You will find a detailed description in:

• Chap. 9 "Cleaning and Disinfection"
• The separate IFU Volume Calibration
Flow Sensor
The heart of the Ergostik for precise flow measurement is the
Ergoflow flow sensor. It must be calibrated after every cleaning
and before the first examination of a day.
As the flow sensor ensures the precise flow measurements, the
cleaning and calibration requirements must absolutely be
adhered to, regardless of the version selected.

Ergostik
4.1.2.3 Pressure Reducer
For safe use, a suitable pressure reducer for the calibration gas
cylinder is required. Please note the following:

Reason: Working pressure too high. Therefore:
• Only use a pressure reducer that meets the
Attention specifications defined by the manufacturer and
provides an outlet pressure of maximum 5 bar!
The manufacturer has approved a suitable pressure reducer as

an optional extension. You can get it from your authorised
specialist retail partner.
• See also chap. 2.2.1 "Original Spare Parts /
Accessories / optional Expansions".
4.1.3 System Construction and Electrical Safety
The following instructions are intended for safe handling of the

entire system, taking into account the electrical safety concept of
the Ergostik.
The system may be set up only by an authorised specialist retail
partner.
It is essential to note: Anyone who combines additional
devices or medical devices or unauthorised or non-original
components / spare parts / consumables with existing
medical, electrical equipment or systems, and this
combination is used by third parties or this combination is
placed on the market, will legally become a producer of a
system or a procedure pack. In any case the assembler of a
system is therefore responsible for compliance with the
requirements placed on the system by the relevant,
harmonised standards and the additional national and
international standards and guidelines in the currently valid
versions!

Ergostik
You will find a detailed description of the correct system

formation in:
• The technical manual "Formation of Systems".
Irrespective of this, please note the following:

Reason: Electric shock due to lack of galvanic
separation with composition of non-approved
• Do not modify or use Ergostik or total system
contrary to the respective manufacturer's
specification!
Reason: Electrical shock and/or misdiagnosis due to
schedules!
Request maintenance work from your
authorised specialist retail partner!
Reason: Misdiagnosis caused by measurement error.
Therefore:
• Do not connect any additional USB devices!
(except mouse, keyboard and printer)
• Do not install any other software!
Ask your authorised specialist retail partner!
which devices are approved by the
manufacturer!

Ergostik

Reason: Electrostatic discharges. Therefore:
• Preferably no floor made of synthetic material!
Attention
• Otherwise a relative air humidity of at least 30 % is
required!
4.1.3.1 Data Connection
The hardware connection between the device and computer is

established via an integrated USB interface and USB cable.
This is considered to be a spare part approved by the
manufacturer and can be obtained from an authorised
• See also chap. 2.2.1 "Original Spare Parts /
Accessories / optional Expansions"
All measurement results and graphical data can be displayed on

the screen as well as printed out via the Windows printer
interface. Any printer compatible with Windows can be used for
this.
4.1.3.2 Equipment Cart with Isolating Transformer
The cart, approved by the manufacturer, meets the

requirements of the IEC 60601 series of standards, so its use is
recommended.
You will find more detailed information in:
• Chap. 2.2.1 "Original Spare Parts / Accessories /
optional Expansions"
• Respectively consult with your authorised specialist
retail partner.

Ergostik
4.1.3.3 Power Supply
The Power Supply is provided by an external desktop Power

Supply Unit. Only this is considered a spare part approved by
the manufacturer and can be obtained from an authorised
• See also chap. 2.2.1.1 "Original Spare Parts /
Accessories"
4.2 Technical Protection Measures

Ergostik has been designed and built in accordance with the
recognised state of technology and the requirements of the
applicable, safety-relevant regulations.
The technical safety condition is checked by the authorised
specialist retail partner of the manufacturers within the
framework of technical monitoring
(see also chap. 3.3 “Operation / Servicing and Maintenance”)
4.3 Software
The measurement device (Ergostik) is supplied with
BLUE CHERRY® software. This serves to manage patient and
examination data as well as carry out, depict, process and
record measurements with the devices of the manufacturer.
The communication between the BLUE CHERRY® software and
a practice computer system or hospital information system is
supported by standardised software interfaces (e.g. HL7, GDT).
Paid software options are necessary for this, if applicable.
A modular and flexible hardware and software concept makes it
possible to combine this with additional measurement options
and consequently allows the overall system to be configured
separately for individual customers.
For the identification of the current firmware version, this can be
read by the BLUE CHERRY® device management system.

Ergostik
For further information see the separate IFU of

BLUE CHERRY® − information on the configuration and use of
the software BLUE CHERRY®.

Ergostik
5 Transport, Storage and Assembly

5.1 Transport to the Location of Use
The Ergostik is transported secured against damages, in a

carton.
The packaging must be kept by the user / operator in case the

device must be returned to the authorised distributor or
manufacturer.
For further information see:
• Chap. 11 “Decommissioning / Disposal”
• Chap. 15 “Warranty and Service“
The specialist retail partner authorised by the manufacturer are

responsible for delivering the Ergostik to the operator and for
unpacking and transporting it to the actual installation location.
5.2 Storage
Requirements regarding space requirements, media connections
and operating conditions can be found in chap. 12
"Technical Specifications".
The responsible organisation of the Ergostik is solely in charge of
compliance with these requirements.
For storage and transport conditions see chap. 12
"Technical Specifications".

Ergostik
5.3 Assembly
Installation or assembly for the first commissioning of the

Ergostik may only carried out by qualified personnel of the
manufacturer's specialist retail partners.

Reason: Electric shock. Misdiagnosis caused by
measurement error. Therefore:
• Prevent improper assembly / installation!

• Ergostik should only be assembled and installed
by officially trained personnel authorised by the
manufacturer!
For further information see:

• Chap. 4.1.3 “System Construction and Electrical
Safety”
Information on assembly work in connection with the
Recommissioning in:
• Chap. 6.2 "Recommissioning after Servicing / Cleaning
Work".

Ergostik
6 Operation
6.1 Initial Operating
The first commissioning of the Ergostik and its recommissioning
after maintenance work in accordance with the operator's
obligations (see chap. 8 "Servicing / Maintenance"), which is
carried out by qualified personnel of the specialist retail partner,
is also only carried out by these qualified personnel.
Ergostik is only completely ready to function after calibration and
once the initial operation is complete.
6.2 Recommissioning after Servicing / Cleaning Work

The responsible organisation is responsible for returning the
device to operation after servicing / cleaning work for which the
operator / user is authorised.
Servicing work here also includes the necessary checks which
are necessary if Ergostik should fall down.

Reason: careless operation. Therefore:
• Assure that all cables and tubes are connected carefully!
Attention • Generally, do not expose cables, tubes and their
connections to mechanical stress such as tension,
pressure, bending or similar!
Possible danger to life

Reason: Electric shock. Therefore:
• Never obstruct the access to the mains plug or
On / Off switch of the equipment cart!
Disconnection of the power supply must be
easily accessible!

Ergostik
Before the Ergostik can be used to perform measurements

again, all components must be properly reconnected, the USB
connection to the computer must be established, and the
Ergostik must be connected to the power supply and calibrated.
Calibration also fulfils the regulatory requirements of MPBetreibV
§7 for functional testing after maintenance work.
Please proceed as described in the respective chapters.
6.2.1 Assembly Calibration Tube

Reason: Measurement error due to leakage caused by
incorrect assembly of components. Therefore:
• Carefully observe the assembly instructions!
Functional disorders possible.

Reason: Components and e.g. plug connections can be
damaged. Therefore:
Attention • All connections must be made carefully and without too
much force!

Ergostik
1. Remove the red

protective caps from
the calibration gas
connection [1] and
gas exhaust [2].
For this:
Unscrew the
protective caps
counterclockwise so
2 1
that the white marked
connections [3] are
accessible.
3
2. Connect the
calibration tube to
the calibration gas
connection.
For this:
Turn calibration tube
[4] clockwise.
3. Connect the minifilter

to the gas exhaust
For this:
Turn the minifilter [5]
clockwise.
5 4

Ergostik
6.2.2 Power Supply and PC-Connection

Reason: Electric shock due to lack of galvanic
separation with composition of non-approved
Only use the
• Power Supply
• USB-Connection Cable
supplied by the manufacturer as spare parts, which are
always part of the medical device.
(See chap. 2.2.1.1 “Original Spare Parts /
Accessories“)
Connect the Ergostik in order to make it ready for operation:

1. USB- connection
cable [1]
to the USB socket of
2b the Ergostik.
1 2. Power supply unit [2]

with
power cord [2a] and
the power supply
2a connection on the
2 Ergostik [2b]
Insert the power plug
into the socket

Ergostik
7 Operating Instructions
7.1 Checking for Worn Parts
The Ergostik should be checked for defective wearing parts

each day before beginning treatments.
You can get a description in:
• Chap. 8 “Servicing / Maintenance”
And:
Reason: Misdiagnosis caused by measurement error
due to incorrect components or improper use.
Therefore:
• Replace the flow sensor and the mouthpiece in
case of a functional error!
• Always follow instructions (see chap. 8 "Servicing
/ Maintenance" and chap. 9 "Cleaning and
Disinfection")!
7.1.1 Minifilter / Permapure Check
The permapure drying tube and

minifilter must be checked regularly
1 for discoloration.
Please note that the permapure tube
and minifilter are transparent as
shown in Fig. [1] and are not
severely discoloured as shown in
Fig. [2].
If the permapure tube turns brown
during the course of use, it should
2 be replaced together with the
minifilter.

Ergostik
7.2 Establishing Operational Readiness
To make the Ergostik ready for operation, please read the

instructions:
• Chap. 7.5ff "Calibrating Ergostik“
7.3 Switching Ergostik On / Off

Reason: misinterpretation of obvious measurement
errors (drift). Therefore:
• Let the Ergostik warm up for 15 minutes!

Measurements may only be performed after this
time!
The Ergostik can be switched off by disconnecting the power

supply. When using a cart, this is done via the On / Off switch on
the cart. Otherwise, the On / Off switch on the back of the
Ergostik must be activated.
To extend the life of the gas sensors, the Ergostik should be
switched off if there are long intervals between measurements.
After switching on the Ergostik needs a warm-up time of
15 minutes. Only after this time is the Ergostik ready for
operation.
Detailed information on how to establish operational readiness

you will find here:
• In this IFU – chap. 7.2 "Establishing Operational
Readiness".
If the calibration as described in chap. 7.5 "Calibrating Ergostik"

has not been carried out already, this must be done later,
otherwise no functional readiness is possible.

Ergostik
7.4 Inserting the Flow Sensor
1. Connect the exercise

tube set [1] with the
2 Ergostik [2]
For this:
1a
Screw the flow- [1a]
and gas tubes [1b]
1b clockwise to the color-
coded connections on
the front of the Ergostik.
1
2. Insert the Ergoflow flow

3 sensor [3].
3a For this:
Press the side with the

connection pins [3a]
vertically onto the
Ergoclip adapter [4],
4a which is located on the
3b tube set, until the
connection pins and the
4 openings provided for
4b
them are connected
[3b].
3. Close and lock the
closing cap [4a].
For this:
Close the cover cap and

push the closure [4b]
upwards until it
engages.

Ergostik
7.4.1 Assembly Face Mask
1. a) Assemble the mask

5 adapter [5] to the face
mask [6].
For this:
6a
Press the adapter
through the round
opening of the silicone
mask so that the lower
ring of the adapter is
inserted into the incision
6a
6 [6a].
b) Position the adapter.
For this:
Position the oval
opening [5a] of the
adapter vertically to the
face mask.
5a
2. Mount the flow sensor

in the Ergoclip adapter
on the face mask.
For this:
Press the flow sensor

with the patient close
side into the receptacle
provided on the
adapter.

Ergostik
7.4.2 Assembly Silicone Mouthpiece
1. Assemble the flow

sensor in the Ergoclip
adapter to the silicone
mouthpiece.
For this:
Press the flow sensor

with the patient close
side into the receptacle
provided on the
adapter.

Ergostik
7.5 Calibrating Ergostik

There are various processes to be carried out for Ergostik in
order to calibrate or validate the volume and gas measurement.
The required intervals can be found in the tables below.
For details on individual calibrations, please read:

• The separate IFU: Calibration
Interval Calibration
Once per day Gas calibration

Once per day, and after changing the flow Volume calibration
sensor
Once per week Flow linearity test
After Maintenance / Cleaning Volume calibration
7.6 Using Ergostik / Performing Measurements
Descriptions of the individual examinations can be found in the

separate IFU:
• CPET
And for general use of the software:
• BLUE CHERRY®

Ergostik

Reason: Disregard of a contraindication.
Misdiagnosis due to measurement errors. For this:
Observe 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)!
Reason: Misdiagnosis due to measurement error
caused by a system failure due to uncontrollable
electromagnetic fields of inadmissible transmitting
devices. Therefore:
• While using Ergostik, do not use any

transmitting devices (e.g. mobile phones,
portable phones, power lines …) that exceed
the immunity levels as specified in the EMC
guidelines!
• Ask your authorised specialist retail partner!
Reason: Electrical shock. Therefore:
• Ensure that the users or third party persons do
not touch the patient and any conductive
connections or parts of the device that are
located outside the patient environment at the
same time!
Reason: Cross-contamination. For this: Observe the

Ergostik

Reason: Penetrating liquid. Uncleanliness. External exposure.
Therefore:
• Do not use any liquids near Ergostik!
• Do not expose Ergostik or the entire system to dust or
other contamination!
• Do not drop any objects on Ergostik!
Attention
• Do not lay any objects on it!
• Never push foreign objects into the housing!
Reason: Condensation. Therefore:
• Do not expose the device to excessive temperature

fluctuations during operation!
7.7 Exchange of Disposable Products / Disinfection

7.7.1 Noseclip

Reason: Cross-contamination. For this: Observe the
• Dispose of noseclip after each use!
The noseclip must be disposed after each examination or

patient.

Ergostik
For further weekly cleaning and disinfection tasks, please see:

• Chap. 9 “Cleaning and Disinfection”
Information about disposal of the disposable products can be
found in:
• Chap. 11.3 "Disposal"
7.7.2 Ergoflow / Mask / Mouthpiece
All parts which have come into contact with the patient or patient
breathing during the examination must be disinfection.
For further weekly cleaning and disinfection tasks, please see:

• Chap. 9 “Cleaning and Disinfection”
Information about disposal of the disposable products can be
found in:
• Chap. 11.3 "Disposal"

Ergostik
8 Servicing / Maintenance
8.1 Duties of the Responsible Organisation
Responsible organisations of medical devices are obligated, in
accordance with the corresponding, applicable regulations, to
preserve the properties of this medical device assured by the
manufacturer over its whole service life. This also includes
carrying out regular and proper servicing as well as safety
checks at intervals recommended by the manufacturer carried
out by specialist personnel who have been authorised by the
manufacturer for the respective tasks.
The expected service life of Ergostik is 8 years.
In its development, a great deal of value was placed on making
the servicing of all device components as simple as possible.
Only a little work is necessary to guarantee a fault-free operation
of the device.
However, to maintain a high quality of measurement results and
the safe operation, the manufacturer recommends having the
device safety and measurement precision checked by an
authorised specialist retail partner every 24 months.
These checks include:
• Visual check
• Electrical measurement
• Functional Check

Reason: Electric shock and/or misdiagnosis due to
schedule!
Request maintenance work from your
authorised specialist retail partner!

Ergostik
Independent of this, the user / operator must carry out regular

checks during day-to-day operation, see also the following
Attention chap. 8 “Servicing / Maintenance by the User”!
8.2 Servicing / Maintenance by the User / Operator

In order to ensure a flawless operation of Ergostik over its whole
service life, regular servicing and repairs, if applicable, are
required.
Intervall Servicing work
Before each Checking the cable and tube connections

examination
Once per day Visual checks of the device and its components for
damage and replacing them if necessary
(see chap. 8.2.1 “Checking / Exchanging of Tubes and
Cables”)
After about 50 to Replacing the permapure tube and filter
100 examinations
After 12 months Replacing the oxygen cell and the exercise tube set

Ergostik

Reason: Electric shock. Misdiagnosis caused by
measurement error. For this: Ensure that the used
components are undamaged and that you are working
in a careful way! Therefore:
• Prior to each use, visually inspect the total
system (housing, connectors, etc.) for any
damages!
• If there are any damages, do not operate the
system. The damaged parts must be replaced
or repaired properly!
Reason: Electric shock. Triggering malfunctions of
Ergostik. Unqualified user / operator can detect
sources of failures too late or even cause them.
Therefore:
• All maintenance and servicing work may only be
performed by specialised personnel who have
been authorised by the manufacturer!
8.2.1 Checking / Exchanging of Tubes and Cables
All parts of Ergostik should be checked for visible mechanical

damage (cracks, tears) each day. If damage is ascertained, the
corresponding component must be replaced.
For replacing components see:

• Chap. 4.1.3 “System Construction and Electrical
Safety“
• Chap. 6.2 “Recommissioning after Servicing / Cleaning
Work“

Ergostik
9 Cleaning and Disinfection
The devices of the manufacturer were designed in such a way

that minimal effort is required for cleaning and disinfection.
This is why just a few tasks are necessary to keep Ergostik
functional and clean.
Cleaning and disinfection may cause discolouration of the
components, but without impairing their function.
The following intervals apply:
Component Interval Method
Noseclip After each patient Dispose of!

Silicone mouthpiece After each patient Cleaning and
disinfection bath
Face mask After each patient Cleaning and
disinfection bath
Mask adapter After each patient Cleaning and
disinfection bath
Network mask After each patient Cleaning and
disinfection bath
Reusable flow sensor, After each patient Cleaning and
Ergoflow disinfection bath
Ergostik Weekly Wipe / surface
disinfection
Ergoclip After each patient Wipe / surface
disinfection
All other touchable parts Weekly Wipe disinfection

Reason: misinterpretation of obvious measuring errors
(drift) caused by liquid in the tubes. Therefore:
• Clean tubes only externally!
• Replace dirty tubes!

Ergostik

Reason: Penetrating liquid into electrical components.
Therefore:
• Disconnect the Ergostik from the power supply before
cleaning and disinfecting!
• (When switching off via the On / Off switch of the
equipment cart), shut down the PC completely before
Attention doing so!
• Wipe off remaining moisture with a dry cloth!
Ergostik could fail.
Reason: Damaged connections. Therefore:
• To disconnect electrical connections, always pull the
plug and never the cable!
9.1 Single Use
For instructions on handling noseclips, read:

• Chap. 7.7 “Exchange of Disposable Products /
Disinfection”
9.2 Disinfection
All parts of the Ergostik can be cleaned of dirt with a soft cloth
using a cleaning solution / weak soapy water.
All parts of Ergostik which come into contact, or could come into
contact, with the patient must be treated with a surface
disinfection. Otherwise, these can be wiped with a soft cloth
using a weak soap solution.

Ergostik
When using a disinfectant that has not been tested and

approved by the manufacturer, the following steps must be
observed:
• Preferably use agents that correspond in composition to
the approved agents. The composition is available on
data sheets, which we can provide on request.
• Check bactericidal and virucidal effect suitable for the
intended use.
• Use only disinfectants listed in public databases (e.g.
RKI)
• Check data sheet for material compatibility with plastics
(especially polyoxymethylene, polystyrene, acrylonitrile
butadiene styrene, Makrolon®) as well as metal
• First test the disinfectant for material compatibility in an
inconspicuous place.
• During the regular visual inspection for damage, also
pay attention to material changes (discoloration, cracks,
embrittlement...)
• Observe long-term trend of calibrations for changes in
measuring function
The manufacturer accepts no liability for any resulting equipment

damage or any consequential damage caused by the use of
disinfectants that have not been tested and approved by the
manufacturer.

Ergostik

Reason: Improper treated components. Therefore:
• For cleaning and disinfection only use those active
substances that are approved by the manufacturer!
(See chap. 2.2.2 "Consumable Items / Auxilary
Materials")!
Attention • Follow the instructions on the concentration and dwell
time stated by the cleanser and disinfectant
manufacturer!
• Do not place Ergostik in the cleaning and disinfection
solutions! The device contains electrical components
that will be damaged by doing so!
For the selection of suitable disinfectants please note:

• Chap. 2.2.2 "Consumable Items / Auxilary Materials".

Ergostik
9.2.1 Ergostik
All parts of the Ergostik which come or could come into contact
with the patient must be treated with surface disinfection.
9.2.2 Flow Sensor- / Ergoclip Removal
1. Remove Ergoflow.
For this:
Proceed in reverse order as described
in chap. 7.4 “Inserting the Flow
Sensor“.
2. Perform wipe disinfection.

For this:
Wipe all accessible surfaces with a wet
disinfecting cloth.

Ergostik

Reason: destruction of the orifice. Therefore:
• Do not clean the interior of the sensor, mechanical or
with hard water jet!
• Do not use any disinfectants which contain high
chloride concentrations!
Reason: Improper treated components. Therefore:
Attention • Observe the maximum permissible temperature of
75 °C for cleaning and disinfection!
• Do not dry with heat!
Possible impairment of the measuring function.
Reason: Moisture in the connection port. Therefore:
• Ensure that there is no moisture in the connection
piece before recommissioning!
1. Remove the flow sensor.

(In reverse order as in chap. 7.4.
"Inserting the Flow Sensor" described).
2. Wipe off visible contamination with a

soft cloth.
3. Put the sensor in disinfectant fluid.
4. Wash the sensor in distilled water

thoroughly so that no residual dirt
and disinfectants remain.
5. Air-dry sensor until no moisture is

visible.

Ergostik
9.2.3 Removing the Silicone Mask / Adapter
1. Remove the adapter.

(In reserve order as described in chap.
7.4.1 “Assembly Face Mask“)
2. Wipe off visible contamination. with a

soft cloth.
3. Insert the adapter and silicone mask

into a disinfectant solution.
4. Wash the adapter and silicone mask

thoroughly in distilled water so that
no residues of contamination and
disinfectants remain
5. Air-dry adapter and silicone mask

until no moisture is visible.

Ergostik
10 Fault Indication and Repair
Simple errors which occur when using Ergostik 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
You will reach your authorised specialist retail partner via

contact form on the manufacturer’s website
Danger to life.
Reason: Unauthorised work carried out by the user to
troubleshoot and rectify an error. Therefore:
• Users may only carry out work which is described
and permitted by the manufacturer!
In case of not complying with this restriction, the
responsible organisation alone is liable for any
resulting injuries to persons and/or damages to
Ergostik!
Error Rectification
Device is not recognised Check power supply (power supply unit and
power cable)
Check power switch on the Ergostik
Check USB connection between PC and
Ergostik
Switch the Ergostik off and on with the power
switch

Ergostik
No flow signal Check that the Ergoflow is correctly positioned in

the Ergoclip
Check the tube connection between Ergoclip
and Ergostik
Drift on flow signal Check that the Ergoflow is correctly positioned in
the Ergoclip
and Ergostik
Check for moisture in the tube / connection
piece of the Ergoflow
Perform volume calibration
No gas signal Check that the Ergoflow is correctly positioned in
the Ergoclip
and Ergostik
Perform gas calibration
Drift on gas signal Note the warm-up time of the Ergostik
(15 minutes)
Software error message Note the warm-up time of the Ergostik
"Unit warm-up not (15 minutes)
completed.
Software error message Check that the Ergoflow is correctly positioned in
"Flow out of measuring the Ergoclip
range". Check tube connection between Ergoclip and
Ergostik

Ergostik
Software error message Check tube connection between Ergoclip and

"O2 out of measuring Ergostik
range“ Check for moisture in the tube / connection
Check gas outlet for blockage
Check the set type of the O2 Sensor
Software error message Check tube connection between Ergoclip and
"CO2 out of measuring Ergostik
range Check for moisture in the tube / connection
Check gas outlet for blockage
obvious measuring error Check that the Ergoflow is correctly positioned in
the Ergoclip
Check tube connection between Ergoclip and
Ergostik
Check the tightness of the Mask / Mouthpiece
Check last calibration date and recalibrate if
necessary (see chap. 7.5)

Ergostik
11 Decommissioning / Disposal
11.1 Expected Service Life
The expected service life of Ergostik has been stated by the
manufacturer as 8 years.
This applies provided the operating conditions, the prescribed
servicing intervals, taking into account and complying with all
safety information such as is described in this IFU as well as
other technical standard regulations are adhered to.
11.2 Decommissioning
To decommission the Ergostik, remove any contaminated
material from it.
11.3 Disposal
In general, the applicable national laws and regulations stipulated
by the local authority should be complied with for disposal.
11.3.1 Transport Packaging
The transport packaging should be reused or sent for material

recycling. Before doing so, you should check whether it is
possible to reuse the packaging.
11.3.2 Ergostik
Ergostik is an active medical device and is thus subject to the

WEEE directive 2012 / 19 / EU and the German law on electrical
and electronic devices (ElektroG) for the disposal for old
electrical items. Neither Ergostik itself, nor any of its components
may be disposed of via household or practice waste.
In order to ensure environmentally friendly disposal, please

contact the authorised specialist retail partner where you
purchased Ergostik and/or the accessories.

Ergostik
11.3.3 Infectious / Contaminated Single Use Items
All contaminated items such as mouthpieces and noseclips must

be disposed of trough the hospital or medical practice waste.
Possible severe physical injury.

Reason: Contamination with transferable germs during
improper disposal. Therefore:
• Dispose single use items (disposable flow
sensors, mouthpieces and noseclips) after each
use. For this observe the applicable regulatory
requirements for biologically hazardous materials!
• Observe regulations on wearing personal
protective equipment (PPE)!

Ergostik
12 Technical Specifications
12.1 Technical Data
Medical device: Class IIa (in accordance with MDD 93 / 42

Council Directive of 14/6/1993 annex IX)
Dimensions: (L) 210 mm x (W) 175 mm x (H) 75 mm
Weight: 1120 g
Electrical data:
Protection class: II
Protection type: IP20 IEC 529
Applied part: BF according VDE 0750 (DIN EN 60601-1)
PC interface: USB 2.0
Power supply: 12 V DC max. 5 A
Power consumption: < 60 VA
EMC: Group 1 / Class B
Noise emission: < 80 dB(A)
Flow measurement:
Flow sensor: Ergoflow
Measuring principle: Differential pressure
Measuring range: ±16 l/s
Ventilation measuring range: 0 – 300 l/min
Flow resistance: < 0.12 kPa/(l/s) < 14 l/s
Dead space: < 32 ml
Flow resolution: 15 Bit
Sample rate: 125 Hz
Accuracy: ±3 % or 50 ml/s

Ergostik
Volume:
Measuring range: 0 – 20 l
Accuracy: ±3 % or 50 ml
O 2:
Principle: Electrochemical cell
Range: 1 - 100 %
Accuracy: ± 0.1 vol% (13 % - 21 %) / ± 1 % FS
t10-90: < 90 ms (after filtering)
CO2:
Principle: Infrared spectroscopy
Range: 0 - 13 %
Accuracy: ± 0.1 vol% (2.5 % - 7.5 %)
t10-90: < 90 ms (after filtering)
Minimum PC system requirements:

Standard: at least EN 62368-1 / EN 60950
recommended EN 60601
Processor: X86 / amd64 compatible,
1 GHz or higher
RAM storage: 1 GB or higher
Hard drive storage: 5 GB or higher
Monitor: XGA (1024 x 768) or higher
PC interface: USB 2.0 recommended
Operating system: Windows 8.1 or higher

Ergostik
12.2 Installation and Operating Conditions

The following conditions supplement chap. 2.2 "Intended Use"
and must be observed to maintain the properties of the Ergostik
guaranteed by the manufacturer and for the safety of the patient
and operator.
Storage / Transport: min. max.

Temperature: -10 °C +50 °C
Relative air humidity: 0% 95 % non-condensing
Operation: min. max.

Environmental temperature: +10 °C +35 °C Avoid extreme
fluctuations in
temperature!
Relative air humidity: 20 % 95 % non-condensing
(at least 30 % for synthetic flooring)
Atmospheric pressure: 800 hPa 1080 hPa
Setup: mobile
Space requirement: (L) 900 mm x (W) 900 mm x (H) 1900 mm
(complete with medical cart)
Required floor load capacity: 150 kg/m²
Flooring: stable; even; conductive
preferably no synthetic material
Environment / room: Closed, clinical area
air-conditioned
not an explosive or flammable environment!
not near an MRI!
well ventilated
Operating Mode: Continuous operation

Ergostik
12.3 Electrical Safety Concept

12.3.1 Ergostik with Medical Device Cart and Isolation Transformer

Ergostik
12.3.2 Ergostik without Medical Device Cart and without Isolation

Transformer

Ergostik
12.4 Electromagnetic Compatibility / EMC Guidelines

The manufacturer tests his products for emitted interference and
interference resistance. Compliance with the relevant standards
and directives is certified in the Declaration of Conformity that
accompanies this device. The results of the EMC test can be
found in the following chapter.
12.4.1 Emitted Interference Guideline and Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic emissions

The Ergostik is determined for operation in an electromagnetic environment as specified below.
The user / operator of the Ergostik should ensure that it is operated in this environment.
Measurement of Compliance Electromagnetic environment – Guideline

electromagnetic emissions
RF emissions CISPR 11 Group 1 The Ergostik uses RF energy exclusively for its
internal function. Therefore, its RF emission is very
low and is improbable to interfere with adjacent
electronic equipment.
RF emissions CISPR 11 Class B The Ergostik is suitable for use in all
Emissions of harmonic Class A establishments, including living areas and those
oscillations according to directly connected to the public supply network,
IEC 61000-3-2 which also supplies buildings used for residential
purposes.
Emissions of voltage Compliance
fluctuations / flicker
according to
IEC 61000-3-3

Ergostik
12.4.2 Interference Resistance for all ME Systems Guideline and

Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity

The user/operator of the Ergostik should ensure that it is operated in this environment.
Measurement of IEC 60601 – test Compliance level Electromagnetic
interference immunity level environment – Guideline
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be made of
(ESD) according to ±8 kV air ±8 kV air wood, concrete or ceramic
IEC 61000-4-2 tiles. If the floor is covered
with synthetic material, the
relative humidity must be at
least 30 %.
Fast transient electrical ±2 kV for power ±2 kV for power The quality of the supply
disturbances Bursts cables cables voltage should be
according to ±1 kV for input ±1 kV for input and appropriate for a typical
IEC 61000-4-4 and output lines output lines business- or hospital
environment
Surges according to ±1 kV Voltage ±1 kV Voltage outer The quality of the supply
IEC 61000-4-5 outer conductor - conductor - outer voltage should be
outer conductor conductor appropriate for a typical
±2 kV Voltage ±2 kV Voltage outer business or hospital
outer conductor conductor end environment
end
Voltage dips, short < 5 % UT < 5 % UT The quality of the supply
interruptions and supply (> 95 % collapse (> 95 % collapse of voltage should be
voltage fluctuations of the UT) the UT) appropriate for a typical
according to for ½ Period for ½ Period business or hospital
IEC 61000-4-11 40 % UT 40 % UT environment.
(60 % collapse of (60 % collapse of
the UT) the UT) If the user of the Ergostik-
for 5 Period for 5 Period system requires continued
70% UT 70% UT operation even during
(30 % collapse of (30 % collapse of power interruptions, it is
the UT) the UT) recommended that the PFT
for 25 Period for 25 Period system be powered from an
5 % UT 5 % UT uninterruptible power supply
(> 95 % collapse (> 95 % collapse of or a battery.
of the UT) the UT)
for 5 s for 5 s
Magnetic field at the 3 A/m 3 A/m Magnetic fields at the mains
supply frequency frequency should
(50/60 Hz) correspond to the typical
to IEC 61000-4-8 values as found in the
business and hospital
environment.

Ergostik
12.4.3 Interference Resistance for None-Life-Supporting ME Systems

Guideline and Manufacturer Declaration
Guidelines and manufacturer’s declaration – electromagnetic interference immunity

The user/operator of the Ergostik should ensure that it is operated in this environment.
Measurement of IEC 60601 -level Compliance level Electromagnetic enviroment -
interference Guidline
immunity
Portable and mobile RF
communication devices should not
be used at a shorter distance from
the Ergostik as the recommended
safety distance calculated
according to the equation
applicable to the transmission
frequency.
Recommended safety distance:
Conducted HF- 3 V Effective value 𝑈𝑈1 = 3 V 3.5
𝑑𝑑 = � � √𝑃𝑃
𝑈𝑈1
distrubance 150 kHz to
variable 80 MHz
IEC 61000-4-6
Radiated HF- 3 V/m 𝐸𝐸1 = 3 V/m 3.5
𝑑𝑑 = � � √𝑃𝑃
𝐸𝐸1
distrubance 80 MHz to
according to 2.5 GHz from 80 MHz up to 800 MHz
7
IEC 61000-4-3 𝑑𝑑 = � � √𝑃𝑃
1𝐸𝐸
from 800 MHz up to 2.5 GHz

Ergostik
P is the maximum rated power of

the transmitter in watts (W)
according to the manufacturer's
specifications
and
d is the recommended safety
distance in meters (m)
Field strengths from fixed RF

transmitters should be less than
the compliance level at all
frequencies according to on-site
investigations.
Interference may occur in the

environment of equipment marked
with the following symbol:
Note 1: The higher frequency range shall be used at 80 MHz and 800 MHz.
Note 2: These guidelines may not be applicable in all cases. The propagation of electromagnetic
parameters is influenced by absorptions and reflections from buildings, objects and people.
a) The field strengths of stationary transmitters, such as base stations and mobile land-based
radios, amateur radio stations, AM and FM radio and television transmitters, can theoretically
not be predicted exactly. In order to determine the electromagnetic environment with regard
to the stationary transmitters, a study of the electromagnetic phenomena of the site should
be considered. If the measured field strength at the site where the Ergostik is used exceeds
the abovementioned compliance levels, the Ergostik should be observed to demonstrate its
intended function. If unusual performance characteristics are observed, additional measures
may be required, such as a change in orientation or in location of the Ergostik.
b) Over the frequency range from 150 kHz to 80 MHz, the field strengths should be less than
3 V/m.

Ergostik
12.4.4 Recommended Safety Distances for Non-Life-Supporting ME Systems
Recommended safety distance between portable and mobile RF communication devices

and the Ergostik
The Ergostik is determined for operation in an electromagnetic environment in which the RF
disturbances are controlled. The user/operator of the Ergostik may help to avoid electromagnetic
interference by keeping the minimum distance between portable and mobile RF
telecommunication devices (transmitters) and the Ergostik, depending on the emitted power of
the communication device as indicated below:
Power rating Safety distance,
of the transmitter depending on the transmitter frequency
[W] [m]
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
𝑑𝑑 = 1.17√𝑃𝑃 𝑑𝑑 = 1.17√𝑃𝑃 𝑑𝑑 = 2.33√𝑃𝑃

0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
For transmitters whose maximum power rating is not given in the table above, the recommended
safety distance d in meters (m) can be determined using the equations given with each column,
where P is the maximum power rating of the transmitter in watts (W) as specified by the
manufacturer.
Note 1: The higher frequency range shall be used at 80 MHz and 800 MHz.
Note 2: These guidelines may not be applicable in all cases. The propagation of electromagnetic
parameters is influenced by absorptions and reflections from buildings, objects and people.

Ergostik
13 Safety of Product and Material
The manufacturer develops, produces and tests its products

according to the essential requirements of MDD 93 / 42 EEC
and the safety standards of DIN EN 60601-1.
All materials which are used are carefully selected and
correspond to the biocompatibility requirements (in accordance
with ISO 10993-1 ff) and those of the RoHS directive
2011/65/EU (RoHS II). All materials in contact with the patient
were evaluated and tested according to DIN EN ISO 10993-
1:2017-04 "Biological evaluation of medical devices"
(biocompatibility).
Ergostik is a class IIa active medical device. Conformity with the
underlying standards and directives is certified in the declaration
of conformity which is included in the documentation
accompanying the device.

Ergostik
14 Product Labeling / Type Label
The type label can be found on the bottom of the Ergostik.

• See chap. 4.1.1 “Overview” point [6].
For more information about the symbols:
• See chap. 1.3 “Symbols”.
1 6
2 7
3 8
5 9
10
11
[1] Manufactuer logo
[2] Product name 12
[3] Product application
[4] Serial number
[5] Catalog number
[6] Manufacturer details
[7] Do not dispose of the device along with general household waste!
[8] Input power
[9] Type label revision indication
[10] Follow the IFU
[11] Conformity mark in accordance with the Medical Device Directive
93 / 42 / EEC with identification of the involved notified body
[12] Date of manufacture
Safety symbols have been applied to the Ergostik type label. It
may not be changed or removed. If information should become
unreadable, the type label should be replaced immediately.
Contact the manufacturer to do this.

Ergostik
15 Warranty and Service

15.1 General Conditions
The manufacturer guarantees that the products you have
purchased fulfill the listed technical data and that the medical
devices are free from technical material and production defects.
This limited warranty is valid for 12 months from the date of
purchase. During this time, the manufacturer declares that it will
replace or repair defective products. The date of purchase
corresponds to the delivery date if the product was purchased
directly from us, or the date of installation if you purchased the
device via a specialist retail partner.
All repairs to products which are covered by the warranty must
be carried out by the manufacturer or by a specialist retail
partner. All warranty claims expire if the repairs were
unauthorised.
15.2 Warranty Exemption

The warranty does not cover damage which was caused by the
following:
• Not complying with the storage or transportation
conditions.
• Improper use, servicing or repair.
• Use of spare parts other than the original spare parts or
spare parts approved by the manufacturer.
• Any technical changes to the device.
• Overvoltage or undervoltage.
• Installing and operating third-party software which has
not been approved by the manufacturer.
• Connecting third-party devices which has not been
approved by the manufacturer.
• Operating the device outside of the valid environmental
conditions.

Ergostik
15.3 Packaging and Shipping

To avoid damage during transport, devices must be sent along
with the warranty claim in the original packaging.
This also applies for defective devices being repaired.
Transport damage arising from improper packing is the
responsibility of the customer. In addition, insurance during
transport is recommended. Claims due to loss or damage must
be made by the shipper.

Ergostik
16 Authorised Specialist Retail Partner
You can reach your responsible specialist retail partner via a

contact form of the manufacturer
see depositors

Ergostik
Attachment – Declaration of Conformity
The Ergostik declaration of conformity is enclosed with each

device by the manufacturer.

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Ergostik

Serial numbers: xx|8|201|yyy and 2201xxxxx

Instruction for Use

Geratherm® Respiratory GmbH

Version: 7 | Release date: 02. August 2021 Page 3

5 Transport, Storage and Assembly ....................................... 49

Page 4 Version: 7 | Release date: 02. August 2021

11.3.1 Transport Packaging .................................................................... 77

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All our medical devices are manufactured and tested in

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Please refer to the separate IFU of the BLUE CHERRY®

The following simplified style of writing and abbreviations are

Instructions for Use  IFU

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Indicates a directly hazardous situation.

Indicates a possibly hazardous situation.

Indicates a possibly hazardous situation.

Not observing this warning information may lead to faults or

Indicates places in the IFU which are relevant to the current

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Symbols displayed in this IFU, on the medical device itself and/or

Follow the instructions for use!

Applied part from type BF corresponding to

IP20 Protection type (safe environmental conditions)

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Do not dispose of the device along with general

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Fragile, handle with care

Keep away from rain

Atmospheric pressure limitation

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The manufacturer reserves all rights to this document and the

1.5 Limitation of Liability

The manufacturer emphasises the creation of accompanying

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Any other use of Ergostik which is not described in this IFU is

2.1 Intended Purpose

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Examination Required option

You can find more information in:

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The Ergostik can be used for cardio-pulmonary (exercise) tests

Evaluation of exercise intolerance

Evaluation of patients with cardiovascular diseases

Evaluation of patients with respiratory diseases

Prescription of pulmonary rehabilitation exercises

Assessment of the impairment / disability

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2.1.2 Contraindication and Side Effect

The following contraindications apply to ergometric

Contraindications Absolute Relative

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High-degree atrioventricular block X

As the transitions between absolute and relative

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2.1.2.2 Side Effects

If there are no contraindications and the examination is carried

Side effect / Frequency Rules of conduct

Exhaustion / Frequent Stopping the exercise after medical