QRS QRS-101, Руководство по эксплуатации

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N O T E S I N A C C O R D A N C E W I T H E C - D I R E C T I V E
A N D M E D I C A L D E V I C E D I R E C T I V E ( M D D )
QRS
®
-101
and
QRS
®
-101 P
are mains-powered magnetic fi eld therapy devices of protection class
I
.
The devices are in accordance with the EC directive for medical devices (93/42/EWG) and therefore carry the
CE sign with the registration number of the notifi ed body for medical devices. The according graphical
symbol is placed on the type plate.
According to the MDD,
QRS
®
-101
and
QRS
®
-101 P
are class
IIa
devices.
The manufacturer is only responsible for the safety, operational reliability and functionality of the device if:
• the device is used in accordance with the operating instructions;
• the electrical installation of the location where the device will be used meets the respective current
requirements of electrical safety;
• the device is not used in hazardous environments and humid locations;
• mountings, enhancements, re-adjustments, modifi cations or repair works are carried out only by
personnel authorized by the manufacturer;
• the operator regulation of this EC directive is observed within the scope of MDD.
Technical support may be obtained by the manufacturer, dealers or service authorized by the manufacturer.
The product’s duration of life as scheduled by the manufacturer is 10 years.
QRS
®
-101
and
QRS
®
-101 P
are electronic devices. For their disposal the according regulations for electronic
devices have to be observed. Incidentals have to be disposed with residual waste.
On request, the manufacturer will provide you with further technical descriptions for all repairable parts of the
device, such as circuit diagrams, spare parts lists, and adjustment instructions as far as these are necessary for
the qualifi ed technical staff of the operator.
Comments on electromagnetic compatibility (EMC)
Medical, electrical devices are subject to special precautions concerning the EMC. They must be installed and
operated according to the EMC-advice given in the accompanying documents. In particular medical, electrical
devices may be infl uenced by portable and mobile RF-communication devices.
The manufacturer guarantees the conformity of the unit with the EMC-requirements only when using
accessories which are listed in the EC declaration of conformity. The usage of other accessories my cause an
increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity.
The unit must not be arranged physically close to other devices or stacked with other devices. If such an order
is necessary nevertheless, the unit must be observed in order to check it for the intentional operation.
You fi nd more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well as in
the Technical Information on the next two pages.
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