QRS QRS-101, Руководство по эксплуатации

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GB
Functionality, reliability, and safety characteristics of the device are only guaranteed in case of proper use in
accordance with the operating instructions. Safety control, maintenance work, repair work, and modifi cations
shall be carried out only by the manufacturer or by service agents authorized by him. In case of a failure, parts
which infl uence the safety of the device shall be only replaced by original spare parts of the manufacturer. The
electric installation must correspond to the requirements in accordance with VDE/IEC.
The device does not contain any parts which need maintenance work done by the user.
7 . 1 S A F E T Y C O N T R O L S
7 . 1 . 1 S TAT U T O R Y R E Q U I R E M E N T S A N D R E G U L AT I O N S
The device is subject to the provisions of the “Medical Device Directive”. The safety controls have to be carried
out on the basis of this directive. Thereby, the “Ordinance on Operators of Medical Devices” has to be especially
observed.
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NOTES
Safety controls have to be made on a basis of the Ordinance on Operators of Medical Devices,
an ordinance connected with Medical Device Directive 93/42/EEC. Please let us point out
clearly that.
• the Medical Device Directive is not valid outside the EC.
• the Ordinance on Operators of Medical Devices is not valid for medical devices which serve
neither commercial nor economic purposes and in whose danger zone no employees are
required to work.
7 . 1 . 2 P E R F O R M A N C E O F S A F E T Y C H E C K S
Irrespective of the legal rules or beyond the scope of the Medical Device Directive, it is recommended to have the
device checked by the manufacturer or by a service agency authorized by him at 24-months intervals
The check shall consist of at least the following criteria:
• Electrical safety check in accordance with the test plan of the manufacturer
• Check of the device in respect of external integrity
• Check of all display and operating elements in respect of damages
• Check of all inscriptions in respect of legibility
7 . M A I N T E N A N C E
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