ergoline ergoselect 4, Operator'S Manual

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1 General Information
ergoselect 4 / 5 5
1 General Information
• The product ergoselect bears the CE marking CE-0123
(Notified Body: TÜV), indicating its compliance with
the provisions of the Council Directive 93/42/EEC about
medical devices and fulfills 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
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 specified 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 classified
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
— modifications 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 firmware version EF 1.5 and higher.