Custo Med Bicycle Ergometer ec3000e - General Information

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GENERAL INFORMATION
• The product ec3000e 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 ergometer is an MDD class IIa product.
• The device fullls the requirements of 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 product 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 equipment. 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 perfor-
mance 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.
It indicates points which 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 equipment users and persons responsible for
assembly, maintenance, inspection and repair of the
device must read and understand the content of this
manual, before using or work on 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 reects the equipment specications
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 custo med will provide a Field Service
Manual.
• The custo med quality management system complies
with the standards ISO 9001: 2008 and EN ISO 13485:
2003-AC2007.
• The safety information given in this manual is classi-
ed as follows:
• To ensure patient safety, the specied measuring ac-
curacy, and interference-free operation, we recom-
mend using only original custo med accessories. The
user is responsible if non-custo med accessories are
used.
• custo med is responsible for the safety, reliability, and
performance of the equipment, only if
- modications and repair are carried out by custo
med GmbH or by an organization expressly au-
thorized by custo med GmbH
- the equipment is used in accordance with the
instructions given in this operator's manual.
custo med GmbH
Lebnzstraße 7
85521 Ottobrunn
Germany
Phone: +49-(0)-89 710 98-00
Fax: +49-(0)-89 710 98-10
e-mail: info@customed.com
http: www.customed.com
Danger
indicates an imminent hazard. If not avoided, the hazard will
result in death or serious injury.
Caution
indicates a potential hazard. If not avoided, the hazard may
result in minor injury and/or product/property damage.
Warning
indicates a hazard. If not avoided, the hazard may result in
minor injury and/or product/property damage.