ergoline VARIOBIKE 500, Operation Manual

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variobike 500 Operation Manual
E - 6
Version: 03/02
Art-No: 475.403
Operation Manual
variobike 500
1.1 General Information
Intended use:
The bicycle ergometer variobike 500 is only to be
used for exercise testing as well as for cardiovascu-
lar rehabilitation. Thereby, the information given in
this operation manual must be strictly observed.
In case the ergometer is not being used according
to above conditions, and if because of that any inju-
ries or serious impact on individuals, or damage of
property are caused, then from this no liability of the
manufacturer can be derived.
•
The bicycle ergometer variobike 500 bears the
CE marking
indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical
devices and fulfills the essential requirements of
Annex
I of this directive.
• The CE marking covers only the accessories
listed in section “Chap. 2.2 Scope of Delivery“.
• The variobike 500 complies with the standard EN
6060-1-1 “Medical Electrical Equipment, Part
I : General Requirements for Safety”, as well
as with electromagnetic immunity requirements
of standard EN 60601-1-2 “Electromagnetic
Compatibility - Medical Electrical Equipment”.
• The symbol has the following meaning:
Refer to Operation Manual.
It indicates points which are of particular impor-
tance in the operation of the device.
• This Operation Manual is an integral part of the
device, and has to be available at the equipment
at any time.
The information contained here is important for
proper use and handling of the ergometer.
Please read the instructions thoroughly to en-
sure the safety of both operator and patient.
Read this manual entirely before installation.
Please note that information applicable to
several chapters is given only once.
• Complying to the safety comments protects from
potential injuries and prevents improper applica-
tion of the ergometer. Each operator of this ergo-
meter as well as personnel which is in charge of
installation, maintenance, examination or repair
of this ergometer, must have read and fully un-
derstood the contents of this Operation Manual
prior to operating or do any work on this device.
Special attention is required at sections la-
belled with additional symbols.
Safety Comments
• If the control panel is opened by unauthorized
persons, the calibration label (production date)
will be damaged. This automatically results in
the cancellation of the warranty.
• This manual is in conformity with the device speci-
fications and standards on safety of electromedical
equipment valid at the time of printing. All rights
are reserved for devices, circuits, techniques,
software programs, and names appearing in this
manual.
• On request, a Service Manual is available from
ergoline GmbH .
• The ergoline quality management system com-
plies with the standards DIN EN ISO 9002 and
EN 46002.
• The safety information given in this manual is clas-
sified as follows:
Danger
This indicates an imminent hazard. If not
avoided, the hazard will result in death or
serious injury.
Warning
This indicates a hazard. If not avoided, the
hazard could result in death or serious injury.
Caution
This indicates a potential hazard. If not
avoided, this hazard could result in minor
personal injury or product/property damage.
• The warranty does not cover damage resulting
from the use of unsuitable accessories and
consumabIes from other manufacturers.
• ergoline GmbH is only responsible for the safety
and reliability of this device if:
m all revisions, enhancements, repairs and ser-
vice to the device are carried out by ergoline
authorized personnel, e.g. an ergoline dealer,
m ambient electrical service where the device is
installed conforms to IEC 601-1 and
m the device is operated in accordance with the
Operation Manual.