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.

3 Symbols
ergoselect 4 / 5 9
3 Symbols
Symbol ’type B applied part’.
Type B applied parts have no direct contact with
patients and oer the lowest protection against
electric shock.
Symbol 'type BF applied part'.
Type BF applied parts are connected to the body of
the patient and provide a higher degree of protection
against electric shock. The applied parts are isolated.
Note: Consult accompanying documents.
Protection class II equipment.
This symbol indicates that the waste of electrical
and electronic equipment must not be disposed of
as unsorted municipal waste and must be collected
separately.
Consult Operator's Manual!
Order number.
Serial number.
nächster
Prüftermin
gemäss MPBetreibV
20
21
22
19
18
17
01
02
03
04
05
06
07
08
09
10
11
12
19
20
21
22
23
24
Scheduled date of the next inspection
(e.g., March 2022).
Toggle switch ON (voltage).
Toggle switch OFF (voltage).
Button to adjust the handlebar height
r Handlebar UP
¡ Toggle switch OFF
s Handlebar DOWN
CE mark per the Medical Device Directive 93/42/EEC
of the European Union.
Notiedbody: TÜV SÜD Product Service GmbH,
Ridlerstr. 65, 80339 München, Germany.
Nationally Recognized Testing Laboratory
NRTL label for the USA and Canada.
Do not lean against device: tipping hazard.
Manufacturer’s identication.
Date of manufacture.
The number found under this symbol is the date of
manufacture in the YYYY-MM-DD format.
PVC-free.
Latex-free.
Suitable for the indicated arm circumference.
Small size.
Standard size.
Large size.
Transport and storage label:
top.
Transport and storage label:
keep dry.
Transport and storage label:
fragile.
Transport and storage label:
approved temperature range.
Transport and storage label:
approved humidity range, non-condensing.
Transport and storage label:
approved pressure range.
Transport and storage label:
do not stack.

4 Setup and Mains Connection
10 ergoselect 4 / 5
4 Setup and Mains Connection
4.1 Controls and Indicators
1
Control terminal M
2
Speed readout for patient
3
Connectors (e.g., for blood pressure cu)
4
Adjustment of handlebar angle
5
Castors
6
Base plate (small)
7
Leveling feet to adjust the ergometer
to uneven oors
8
Sockets for power cord and connection cables
(underside of ergometer)
9
Power switch (toggle switch [I/ 0])
10
Saddle adjustment with clamping lever
12
3
4
5
6
7
8
9
10
Figure 4 – 1: ergoselect 4 M
1
Control terminal T
2
Speed readout for patient
3
Connectors (e.g., for blood pressure cu, SpO2)
4
Adjustment of handlebar angle
5
Height adjustment for handlebar
(by means of toggle switch, option)
6
Castors
7
Baseplate (large)
8
Leveling feet to adjust the ergometer
to uneven oors
9
Sockets for power cord and connection cables
(underside of ergometer)
10
Power switch (toggle switch [I/ 0])
11
Saddle adjustment
(optionally with gas pressure spring or motor)
1
2
3
4
11
6
7
8
9
10
5
Figure 4 – 2: ergoselect 5 T

4 Setup and Mains Connection
ergoselect 4 / 5 11
4.2 Transport
For short distances, the ergometer can be lifted at the
saddle and rolled away on its castors.
To cover greater distances, however, we recommend the
following method:
• Disconnect the power cord and the connection cables.
• Rotate the handlebar towards the front and tighten the
clamping lever.
• Stand in front of the ergometer, grasp the handlebar
and tilt the ergometer towards you until it is standing
on the castors only and is balanced.
• It is now possible to transport the ergometer.
• When you have reached the new location, lower the
ergometer very carefully to protect it from considerable
damage.
Caution
Equipment Damage
Avoid strong vibrations of the ergometer during
transport.
Figure 4 – 3: Transporting the ergoselect
4.3 Setup
Place the ergometer on a horizontal level oor.
The ergometer must be set up in a secure and stable position;
the two leveling feet at the back make for easy adjustment
to uneven oors. An optional anti-tipping device is avail-
able to enhance the stability.
Extend the foot concerned until the ergometer no longer
wobbles.
In case of delicate ooring, it is recommended to place
a mat under the ergometer to protect the ooring from
damage by the feet.
Figure 4 – 4: Leveling feet of the ergometer

4 Setup and Mains Connection
12 ergoselect 4 / 5
4.4 Mounting the Control Terminal
The control terminal can be installed with the display
facing either the patient or the operator.
It is recommended to install the terminal with the display
and control keys towards the operator and the speed read-
out towards the patient.
Note
Only a specialist dealer is allowed to change the
orientation of the control terminal. If the control
terminal is mounted inappropriately, the tubing
andcables may be bent or damaged. The device
will only operate correctly if the tubing and cables are properly
arranged.
Figure 4 – 5: Different orientations of the control terminal
4.5 Mounting the Leadwire Holder
Using the height spacer
1
and 2 Allen screws with
washers
3
, screw the gooseneck
2
to the sides of the
control terminal adapter.
1 2 3
Figure 4 – 6: Leadwire holder components
Figure 4 – 7: Mounting the leadwire holder

4 Setup and Mains Connection
ergoselect 4 / 5 13
4.6 Connecting the Power Cord
Stand in front of the ergometer (looking at the control
panel) and rmly grasp the handlebar with both hands.
Then tilt the ergometer carefully to one side (it is recom-
mended to do this with the help of a second person) and
place it on the oor so that it rests on the handlebar.
Figure 4 – 8: Assembly position
Caution
Equipment Damage
Before connecting the ergometer to the power
line, check that the line voltage corresponds to the
ratings on the type plate.
The type plate is located on the back of the device, at the
bottom.
The connection panel is located on the underside of the
ergometer.
• Connect the power cord to socket
1
.
• Using the supplied strain relief, attach the power cord
tothe metal frame
2
.
Return the ergometer carefully to its upright position and
make sure that it is not standing on the power cord.
1
2
Figure 4 – 9: Underside of the ergometer

4 Setup and Mains Connection
14 ergoselect 4 / 5
1
2
Figure 4 – 10: Connecting the power cord
1
Power input
2
Strain relief
Note
Disconnection from Power Supply
Pressing the power switch or removing the power
cord disconnects the device from the power supply.
Removing the power cord results in a complete disconnection
of the device from the power supply (all poles).
Ensure that the power plug is readily accessible at all times.
4.7 Data Interfaces
The ergometers are prepared for a functional connection
with a PC or a medical electrical device (ME device) via USB
or serial interface.
Dierent connection cables are available to support dierent
communication modes (digital, analog, remote start, etc.).
All ergometers are equipped with a digital interface. (Spe-
cial adapters are needed for analog control or the remote
start capability. Please contact ergoline for these adapters.)
The connection cable is plugged into the 9-pole socket of
the connection panel (Port1) or the USB port and secured
at the metal frame with an additional strain relief.
USB Port 1USB Port 1
Figure 4 – 11: Connection to electrocardiograph / PC-based ECG
system
USB PC connection via USB (virtual COM)
PORT 1 Digital connection (remote control from
PC or ECG recorder), connection for cable
adapter (analog interface + remote start)
Note
Connection Cables
Use only connection cables approved by ergoline.
A special PC driver software, which can be obtained
from ergoline, is required for operation via the USB port.

4 Setup and Mains Connection
ergoselect 4 / 5 15
4.8 Connecting ECG Leadwires
Plug the ECG leadwires (
R
,
N
,
L
) into the appropriate
sockets
1
in the control terminal, observing the color
codes on the leadwires and ergometer.
Warning
Connecting the leadwire to the wrong socket may
cause an incorrect ECG signal.
1
R N L
Figure 4 – 12: ECG leadwire connections
Note
Only available with control terminal T.
4.9 Connecting the Blood Pressure Cu
• Connect the microphone cable for blood pressure mea-
surement to the intended port
1
so that it clicks into
place.
• Slip the cu tubing onto the tting
2
and engage.
To disconnect, push back the connector's knurled
sleeve.
Artifacts must be avoided while the blood pressure is being
taken. They may be caused by patient movements during
the exercise test.
Therefore, do not forget to attach the cu tubing to the
handlebar with the supplied Velcro tape:
• Open the large Velcro tape and wrap it around the
handlebar.
• Secure the cu tubing with the small Velcro tape, but
do not exert pressure on the tubing.
1 2
Figure 4 – 13: Blood pressure cuff connections
1
Microphone connection
2
Fitting for connection of cuff tubing
Figure 4 – 14: Velcro tape to secure the cuff tubing

4 Setup and Mains Connection
16 ergoselect 4 / 5
4.10 Connecting the SpO2 Sensor
Before application and use, check the SpO2 sensor and its
package for damage. Do not use the sensor if you detect
any signs of damage.
Connect the sensor cable to the corresponding socket
1
on the underside of the control terminal.
1
Figure 4 – 15: Connecting the oxygen saturation sensor
1
SpO2 port

5 Applied Parts
ergoselect 4 / 5 17
5 Applied Parts
5.1 ECG
5.1.1 Contraindications
• The general, absolute contraindications to cardiac stress
testing (according to the ergometry guidelines, DGSP
(German Sports Physicians Association)) apply.
– Acute myocardial infarction
– Unstable angina
– Cardiac arrhythmia causing symptoms and/or
hemodynamic instability
– Symptomatic severe aortic stenosis
– Decompensated heart failure
– Acute pulmonary embolism
– Acute myocarditis
– Acute pericarditis
– Acute aortic dissection
• Patients with physical, psychological, or mental aic-
tions who cannot be mobilized and are therefore not
capable of using rehabilitation facilities.
5.1.2 Intended Purpose
The ECG module is a device for recording of a single-chan-
nel, bipolar surface ECG (frontal plane) acquired with three
ECG electrodes. It is used to continuously monitor the heart
rate and the cardiac rhythm and to control the training
load for patients in rehabilitation or preventive training
programs.
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional
healthcare institutions for inpatient and outpatient care.
5.1.3 Safety Information
Warning
No monitoring device
There is a risk of life-threatening patient condi-
tions going unnoticed.
The ECG system is not suitable for the electrocar-
diographic monitoring of critical care patients.
No pacemaker detection
There is a risk of inadequate therapy and/or over-exertion.
The ECG module may continue to count the pacemaker rate
during cardiac arrest or in the presence of some arrhythmias.
Do not rely entirely upon rate meter alarms.
The ECG module has no pacemaker pulse rejection capability.
Keep pacemaker patients under close surveillance. The primary
user is required to periodically assess the current exertion level
by referring to independent, subjective parameters (e.g., the RPE
value).
No debrillation protection
The ECG module is not an applied part with defibrillation
protection. Before a debrillation pulse is released, the ECG
leadwires must be removed from the patient because it
CANNOT be excluded that they conduct the debrillation
energy to the ECG module.
Conductive materials
Electric shocks or malfunction of the ECG system may result
from contact with conductive materials.
Conductive parts of the ECG system must not touch other
conductive parts, including ground, during application to or
removal from the patient.
Follow the sequence of steps for application and removal of the
ECG system described in this manual.
Visual inspection before use
Before each use, visually inspect the ECG system for signs of
damage. If you detect damage that may result in a hazard to the
patient or the operator, the ECG system must be repaired before
it can be used again. Follow the instructions for visual inspection
given in this manual.

5 Applied Parts
18 ergoselect 4 / 5
5.1.4 Disposable Electrodes
Note
• Only commercially available stress test ECG
electrodes approved for medical application may
be used for ECG acquisition.
• Keep the electrode contacts away from other conductive parts.
• Attach disposable electrodes (see gure 5–1)
• Connect leadwires with snap fastener to the electrodes
• Place leadwires in gooseneck holder
5.1.5 Suction electrode system
Note
Higher suction levels may cause hematomas or skin
irritation in patients with sensitive skin. Check that
the suction level is appropriate for the patient. In
the case of patients with medical conditions such
as arterial occlusive disease or severe blood coagulation disease,
the physician must decide whether or not to use the device.
R
L
N
1-Kanal-EKG
Figure 5 – 1: ECG electrode placement
• Switch on the suction electrode system and select the
"middle" level (see section “ECG Mode” on page48)
• Prepare the skin for electrode placement with contact
spray (ergouid)
• Attach the electrodes (see gure 5–1), briey tap on the
electrode to generate suction: the pump starts up
• Adjust the vacuum intensity if necessary (see section
“ECG Mode” on page48)
Note
Do not spray the contact agent onto the electrodes
or leadwires.
Do not under any circumstances use water or contact gel.
Use only the recommended contact spray (ergouid).