ergoline ergoselect 10 M User manual

Manual
ergoselect 10
Couch Ergometer
Operator's Manual
201000546000 • Version 2018-10-08 / Rev 01 • English

ergoselect 10 1
This manual was written with the utmost care. Should you still nd details that do not correspond
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 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 manufacturer'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.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [email protected]
http: www.ergoline.com
Printed in Germany
ergoselect 10
Couch Ergometer
Operator's Manual
201000546000 • Version 2018-10-08 / Rev 01 • English

2 ergoselect 10

ergoselect 10 3
Contents
1General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Safety Information for Non-Invasive Blood Pressure Measurement . . . . . . . . . . 7
2.2 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Biocompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.5 Applicable Laws, Regulations and Directives . . . . . . . . . . . . . . . . . . . . . . . . . 8
3Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4Setup and Mains Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.4 Mounting Attachment Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.5 Connecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.6 Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.7 Start-up and Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
5.1 Adjusting the Couch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.1 Preparing the Couch with the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
7Preparing the Patient for Blood Pressure Measurements . . . . . . . . . .18
7.1 Cu Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.2 Microphone Position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
7.3 Applying the Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8Control Terminals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.1 Control Terminal M. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.1.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.1.2 Operating Mode with Control Terminal M . . . . . . . . . . . . . . . . . . . . .21
8.2 Control Terminal P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
8.2.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
8.2.2 Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8.3 Control Terminal T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
8.3.1 Turning the System On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.3.2 Operating Modes with Control Terminal T . . . . . . . . . . . . . . . . . . . . .33
Contents

4 ergoselect 10
9Cleaning, Maintenance, Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.1 General Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.2 Cleaning the Saddle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
9.4 Cleaning the Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
9.4.1 Removing the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
9.4.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
9.4.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9.4.4 Inserting the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.5.1 Checks Before Each Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.5.2 Technical Safety Inspections and Inspections of the Measuring System. . 49
9.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
10 Technical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
10.1 Ergometer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
10.2 Blood Pressure Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
10.3 Exercise Test Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
10.4 Test Protocols (control terminal T only). . . . . . . . . . . . . . . . . . . . . . . . 52
10.5 Family of characteristics of the braking torque control range. . . . . . . . . 53
10.6 Family of characteristics of the load periods according to IEC60601-1 . . 53
11 Electromagnetic Compatibility EN 60601-1-2 . . . . . . . . . . . . . . . . . 54

1 General Information
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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 fulfills the requirements of the standard
EN60601‑1 "Medical electrical equipment, Part1:
General Requirements for Safety" as well as the inter‑
ference 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 I.
• This manual is an integral part of the device. It should
be available to the equipment 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 symbols mean:
Consult accompanying documents.
They indicate 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.
• By opening the control terminal, you will damage the
calibration sticker. This will automatically void the
warranty.
• This manual reects the device specications and appli‑
cable 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 GmbH will provide a Field Service
Manual.
• The implemented quality management system covers
all aspects of the ergoline GmbH 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 specied measuring accu‑
racy, and interference‑free operation, we recommend
using only original ergoline GmbH accessories. The user
is responsible if accessories from other manufacturers
are used.
• ergoline GmbH is responsible for the safety, reliability,
and performance of the device, only if
— assembly operations, extensions, readjustments,
modications, or repairs are carried out by ergoline
GmbH or by an organization expressly authorized
by ergoline GmbH to carry out these tasks
— the equipment is used in accordance with the
instructions given in this operator manual.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
email: [email protected]
http: www.ergoline.com

2 Safety Information
6ergoselect 10
2 Safety Information
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 tempera-
tures.
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.
• Risk to Persons •
Before using the ergometer, the operator 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 GmbH 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 frequently
even though the speed is above 30 RPM, this may be due to
electromagnetic interference.
Note
The device characteristics determined by emissions allow the
device to be used in industrial environments and in hospitals
(CISPR 11, class A). When used in domestic surroundings
(whichnormally requires compliance with CISPR 11 class B),
thedevice may not oer adequate protection for radio services.
Ifrequired, the user may have to take remedial action by
relocating or re-orienting the device.
Warning
• Shock Hazard •
When the device is connected to other equipment or if a medi-
cal 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 assem-
bly of the device
• must be familiar with and observe the safety rules and
regulations for operation of this type of equipment
• must be informed about any other pertinent rules and
regulations (e.g., safety instructions)
• must be informed about the potential hazards arising from
the use of this type of equipment
• make sure that no unauthorized changes are carried out.
Note
Only the removal of the power cord will result in an all-pole
disconnection of the device from the power line.
Caution
Additional equipment connected to medical electrical equip-
ment must comply with the respective IEC or ISO standards
(e.g., IEC 60950 for data processing equipment).
Furthermore all congurations shall comply with the require-
ments for medical electrical systems (see IEC 60601-1-1 or
clause 16 of the 3rd edition of IEC 60601-1, respectively).
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. Attention is drawn to the fact that
local laws take priority over the above mentioned requirements.
If in doubt, please consult your local dealer or ergoline GmbH.

2 Safety Information
6ergoselect 10 ergoselect 10 7
2.1 Safety Information for
Non‑Invasive Blood Pressure
Measurement
Warning
• Patient Hazard •
Do not take blood pressure measurements with a cuff on
patients suering from sickle cell anemia or if skin lesions are
likely to occur.
The cu may cause hematomas in patients with severe blood
coagulation disease. In these instances, the user must take a
decision for or against automatic blood pressure measure-
ments.
Caution
• Compromised Measuring Accuracy •
Arrhythmias occurring frequently during a measurement may
compromise the accuracy of the measurement.
Valid measurements may not be possible under certain circum-
stances.
Electromagnetic elds are also capable of impairing the mea-
suring accuracy.
Note
• If the cu pressure exceeds the maximum value of 300mmHg
during ination, the ination procedure will be aborted and
the cuff deflated. As a redundant safety precaution, the
cu is immediately deated when the cu pressure exceeds
320mmHg.
You can check the proper functioning of this safety precau-
tion by abruptly bending your arm while the cu is being
inated, causing a brief overpressure in the cu. The cu
must deate immediately.
• Measurements that do not yield a valid measurement will
not be repeated during the exercise test.
• If the ination phase takes longer than 40 seconds or if an
adequate pressure does not build up in the cuff within a
reasonable period of time, the measurement will be aborted
and the cu deated.
• If a valid measurement cannot be completed within
120seconds, the measurement will be aborted and the cu
deated.
• If the cu pressure remains constant for some time, the
measurement will also be aborted and the cu deated.
2.2 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).
2.3 Intended Use
The ergoselect 10 is a computer‑controlled medical ergo‑
meter, which operates at pedal speeds between 30 and
130RPM and loads between 6 and 999 W.
The speed‑independent range is shown in the Appendix
(Technical Specications).
The ergoselect ergometers 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 directly in contact
with the human body (e.g., blood pressure measuring
devices).
Note – Stability
• Ensure the stability of the ergometer. If the maximum per-
mitted patient weight is exceeded by +10 %, the stability of
the ergometer can no longer be guaranteed. It may become
unstable as a result.
2.4 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
GmbH or an ergoline GmbH representative.

2 Safety Information
8ergoselect 10
2.5 Applicable Laws, Regulations
and Directives
If you have questions about the validity of applicable laws,
regulations and directives, please contact ergoline GmbH.