ergoline ergoselect 4 User manual

Manual
ergoselect 4 / 5
Ergometer
Operator‘s Manual
201000433000 • Version 2021-06-01 / Rev 04 • English

ergoselect 4 / 5 1
ergoselect 4 / 5
Ergometer
Operator‘s Manual
201000433000 • Version 2021-06-01 / Rev 04 • English
This manual was written with the utmost care. Should you still nd details that do not corre-
spond with the system, please letus know and we will correct the issue as soon as possible.
We reserve the right to modify the design and technical features of the device and are not
bound by the information and illustrations provided in this manual.
All trademarks appearing in this document are trademarks of their respective owners. Their
protection is acknowledged.
No part of this manual may be reprinted, translated or reproduced without the manufactur-
er‘s written permission.
This manual will not be automatically updated. Please contact the manufacturer for the
latest document revision.
This manual also describes optional components that are not included in the standard scope
of delivery of this product.
The document "Cleaning, and Disinfecting ergoline Medical Devices" (Part No. 201000641000)
in its most recent version is also part of this manual. This document is exclusively made
available for download from the ergoline website www.ergoline.com.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [email protected]
http: www.ergoline.com

Contents
1General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2Safety Information – Basic Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 Intended Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Intended User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2.4 Intended Patient Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Biocompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6 Applicable Laws, Regulations and Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4Setup and Mains Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.1 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.4 Mounting the Control Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
4.5 Mounting the Leadwire Holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6 Connecting the Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.7 Data Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
4.8 Connecting ECG Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.9 Connecting the Blood Pressure Cu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.10 Connecting the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5Applied Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1 ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
5.1.1 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.2 Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
5.1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
5.1.4 Disposable Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.1.5 Suction electrode system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.1.6 Checking the ECG Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
5.2 Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
5.2.2 Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.3 Safety Information for Non-Invasive Blood Pressure Measurement. . . . . . . 20
5.2.4 Cu Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.5 Applying the Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.2.6 Microphone Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.7 Checking the Cu Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.3 SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
5.3.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
5.3.2 Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.3.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.3.4 Applying the SoftTip SpO2 Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.3.5 Applying the Standard SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
5.3.6 Applying the Ear Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2 ergoselect 4 / 5

5.4 Heart Rate Monitoring System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.4.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
5.4.2 Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
5.4.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
5.4.4 ergoline Digital Chest Strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
5.4.5 Polar Chest Strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
6Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.1 Speed Readout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.2 Handlebar Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
6.3 Saddle Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.3.1 Motor-Assisted Saddle Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.3.2 Mechanical Saddle Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.3.3 Saddle Adjustment with Gas Pressure Spring . . . . . . . . . . . . . . . . . . . . . . 32
7Control Terminal M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
7.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
7.2 Operating Mode with Control Terminal M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
8Control Terminal P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
8.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
8.2 Operating Modes with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
8.2.1 PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
8.2.2 Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
8.2.3 Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
8.2.4 Settings with Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
9Control Terminal T. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.2 Operating Modes with Control Terminal T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.2.1 PC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
9.2.2 Ergometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
9.2.3 Training / Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
9.2.4 Training with Chip Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
9.2.5 Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
9.2.6 Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
10 Accessory / Compatible Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
10.1 Accessories Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
10.2 Compatible Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
11 Cleaning, Disinfection and General Hygiene Measures. . . . . . . . . . . . . . 81
Contents
ergoselect 4 / 5 3

12 General Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
12.1 Checks Before Each Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
12.2 Technical Safety Inspections and Inspections of the Measuring System . . . . . . 82
12.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
13 Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
13.1 Ergometer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
13.2 Blood Pressure Module [Option B]. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
13.3 SpO2 Module [Option S]. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
13.4 ECG Module [Option A] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
13.5 Exercise Test Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
13.7 Test Protocols (control terminal T only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
13.8 Family of characteristics of the braking torque control range . . . . . . . . . . . . . 88
13.9 Family of characteristics of the load periods according to IEC60601-1 . . . . . . 88
14 Electromagnetic Compatibility EN60601‑1‑2. . . . . . . . . . . . . . . . . . . . . 90
4 ergoselect 4 / 5

1 General Information
ergoselect 4 / 5 5
1 General Information
• The product ergoselect bears the CE marking CE-0123
(Notied Body: TÜV), indicating its compliance with
theprovisions of the Council Directive 93/42/EEC about
medical devices and fullls the essential requirements
of Annex I of this directive.
The CE marking covers only the accessories listed in the
Order Information chapter.
The device is an MDD class IIa product.
• The device fullls the requirements of the standard
EN60601-1 "Medical electrical equipment, Part 1:
General Requirements for Safety" as well as the
interference protection requirements of standard
EN60601-1-2 "Electromagnetic Compatibility –
Medical Electrical Devices".
The radio-interference emitted by this device is within
the limits specied in EN55011, classB.
• The symbol means: protection class II.
• This manual is an integral part of the device. It should
be available to the device operator at all times. Close
observance of the information given in the manual
is a prerequisite for proper device performance and
correct operation and ensures patient and operator
safety. Please note that information pertinent to several
chapters is given only once. Therefore, read the manual
once carefully in its entirety.
• The symbol means: Follow the instructions in
the documentation.
It indicates points that are of particular importance in
the operation of the device.
• Observance of the safety information protects from
injuries and prevents inappropriate use of the device.
All device users and persons responsible for assembly,
maintenance, inspection, and repair of the device must
read and understand the content of this manual, before
using the device or working with it. Paragraphs with
special symbols are of particular importance.
• If unauthorized individuals open the control terminal,
damaging the calibration sticker, any warranty claim
shall become void.
• This manual reflects the device specifications and
applicable safety standards valid at the time of printing.
All rights are reserved for devices, circuits, techniques,
software programs, and names appearing in this manual.
• On request ergoline will provide a Field Service Manual.
• The implemented quality management system covers
all aspects of the ergoline operations as per ENISO
13485: 2016.
• The safety information given in this manual is classied
as follows:
Danger
indicates an imminent hazard. If not avoided,
thehazard will result in death or serious injury.
Warning
indicates a hazard. If not avoided, the hazard may
result in minor injury and/or product/property
damage.
Caution
indicates a potential hazard. If not avoided, the
hazard may result in minor injury and/or product/
property damage.
• To ensure patient safety, the specified measuring
accuracy, and interference-free operation, we recom-
mend using only original ergoline accessories. The user
is responsible if accessories from other manufacturers
are used.
• ergoline is responsible for the safety, reliability, and
performance of the device, only if
— modications and repair are carried out by ergoline
GmbH or by an organization expressly authorized
by ergoline GmbH
— the device is used in accordance with the instruc-
tions given in this operator manual.
• The functions described in this manual refer to ergo-
meters with rmware version EF1.5 and higher.

2 Safety Information – Basic Device
6ergoselect 4 / 5
Danger
Explosion Hazard
The device is not designed for use in areas where
an explosion hazard may occur.
Explosion hazards may result from the use of ammable anes-
thetics, skin cleansing agents, or disinfectants.
Warning
Patient Hazard, Equipment Damage
Do not expose the ergoselect to direct sunlight
to prevent system components from reaching
inadmissible high temperatures.
Do NOT use the ergoselect outdoors (medical device). Further-
more, the device has no additional protection against the
ingress of humidity. Humidity inside the device may cause
equipment malfunctions and increases the risk of an electric
shock.
Additionally, the device should not be operated in the vicinity of
power systems, because they may impair equipment functions.
The ergoselect may only be used in combination with accesso-
ries approved by ergoline GmbH.
Personal Injury
Before using the ergometer, the user must ascertain that it is
incorrect working order and operating condition. The cables
and connectors, in particular, must be checked for signs of
damage. Damaged parts must be replaced immediately.
Equipment Malfunction
Only the special shielded cables supplied by ergoline may be
used to connect the device to other pieces of equipment.
Equipment Malfunction
Cellular telephones may not be used in the immediate vicinity
of the ergometer, because they might interfere with the proper
functioning of the ergometer.
Electromagnetic interference most probably exists when the
watt reading is unstable. If the displayed value changes fre-
quently even though the speed is above 30RPM, this may be
due to electromagnetic interference.
Warning
Shock Hazard
When the device is connected to other equip-
ment or if a medical system is created, it must
be ensured that the added leakage currents do
not present a hazard. In case of questions, please contact your
ergoline dealer or the ergoline GmbH Service Department.
For use, the ergometer must always be connected to electric
installations that fulll the local requirements.
Patient Hazard
The German Medical Device Operator Ordinance (MPBetreibV, §5)
demands that users
• must be trained in the use of the ergometer
• must be familiar with the routines for handling and assembly
of the ergometer
• must be familiar with and observe the safety rules and regu-
lations for operation of this type of equipment
• must be informed about any other pertinent rules and regu-
lations (e.g., safety instructions)
• must be informed about the potential hazards arising from
the use of this type of equipment
• must make sure that no unauthorized changes are carried out.
Patient Hazard
The medical device is only intended for use by trained and
appropriately qualied sta.
Caution
Additional equipment connected to medical
electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 60950
fordata processing equipment).
Furthermore, all congurations must meet the requirements
ofthe applicable medical systems standards (see 3rd edition
ofIEC 60601-1).
Anybody connecting additional equipment to medical electrical
equipment congures a medical system and is therefore respon-
sible for the system´s compliance with the requirements for
medical electrical systems. Users are reminded that local laws
take priority over the above mentioned requirements.
If in doubt, please consult your local dealer or ergoline GmbH.
Note
Only the removal of the power cord will result in
anall-pole disconnection of the device from the
power line.
2 Safety Information – Basic Device

2 Safety Information – Basic Device
ergoselect 4 / 5 7
2.1 Contraindications
The following patient categories are excluded from using
the device:
• patients feeling discomfort or suering from dizziness,
nausea or pain.
• patients under the inuence of substances that may
impair vigilance (alcohol, drugs, medication).
Contraindications in exercise testing carried
out with ergometers
(source: Banerjee A et al., 2012)
Contraindications in exercise testing:
• acute myocardial infarction in the previous 4 to 6 days
• unstable angina with rest pain in the previous 48 hours
• uncontrolled heart failure
• acute myocarditis or pericarditis
• acute systemic infection
• deep vein thrombosis as it is likely to shift and cause
pulmonary embolism
• uncontrolled hypertension with systolic blood pressure
>220mmHg or diastolic blood pressure>120mmHg
• severe aortic stenosis
• severe hypertrophic obstructive cardiomyopathy
• untreated life-threatening arrhythmia
• dissecting aneurysm
• recent aortic surgery
• abnormalities during testing include:
− abnormal ST-segment response (horizontal, planar,
or down-sloping depression of >1mm).
− T-wave elevation of >1mm in leads without Q-waves.
− T-wave changes such as inversion and pseudo-
normalization when an inverted T-wave becomes
upright are non-specic changes.
Criteria for stopping bicycle-based exercise
testing
(source: Banerjee A et al., 2012).
Criteria for stopping bicycle based exercise testing include:
ECG criteria
• severe ST depression of >3mm
• ST elevation >1mm in non-Q-wave lead
• frequent ventricular extra systoles
• onset of ventricular tachycardia
• new atrial brillation or supraventricular tachycardia
• development of new bundle branch block
• progression of heart block to second or third degree
• cardiac arrest
Clinical criteria
• excessive fatigue
• severe chest pain, dyspnoea, or dizziness
• > 20 mmHg reduction in systolic blood pressure
• rise in blood pressure
2.2 Intended Purpose
The ergoselect is a computer-controlled medical ergometer,
which operates at pedal speeds between 30 and 130RPM
and loads between 6 and 999W.
The speed-independent range is shown in chapter13.7 on
page88.
The ergoselect ergometer may only be used in exercise
testing and for rehabilitation of cardiac and cardiovas-
cular patients according to the instructions given in this
manual. If the ergometer is used for other purposes, the
manufacturer cannot be held liable for personal injuries or
property damage resulting from the unintended use of the
equipment.
Note
Applied Parts
Applied parts are components that are in direct
contact with the human body (e.g., sphygmoma-
nometers).
Note
Stability
Ensure the stability of the ergometer. If the maximum
permitted patient weight is exceeded, the stability
of the ergometer can no longer be guaranteed. It may become
unstable as a result.
2.3 Intended User
Only the intended users are allowed to use the ergometer.
The group of intended users includes:
• healthcare professionals thoroughly instructed on the
basis of the operator manual
• patients of the intended patient group who have been
thoroughly instructed by trained specialists
The group of intended users does not include persons with
special needs, such as:
• impaired mental and physical abilities
• impaired motor skills
that have an influence on the intended use of the
medical device.

2 Safety Information – Basic Device
8ergoselect 4 / 5
2.4 Intended Patient Group
The intended patient group includes all persons
• with a maximum weight of 160 kg
• whose body height and age makes them eligible for
exercise testing. Due to various ergonomic aspects, it is
not possible to provide exact data for body height and
age.
• whose medical condition has been checked by a medical
specialist who judged them to be suitable for the appli-
cation described in the intended use.
2.5 Biocompatibility
The parts of the product described in this manual, includ-
ing all accessories that come in contact with the patient
during the intended use, fulll the biocompatibility require-
ments of the applicable standards if applied as intended.
If you have questions in this matter, please contact ergoline
or an ergoline representative.
2.6 Applicable Laws, Regulations
and Directives
If you have questions regarding laws, regulations or direc-
tives related to the product, please contact ergoline GmbH.