KaVo 1.008.3500, Инструкция по эксплуатации

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Instructions for use EXPERTsurg LUX – 1.008.3500
2 Safety | 2.10 Information about electromagnetic compatibility
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As a result of the use of NON-KaVo original spare parts during the repair, parts
such as covers may become undone and injure the patient, user or other
people. This may result in aspiration, swallowing of parts and possibly even a
risk of suffocation.
4 Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.
2.10 Information about electromagnetic compatibility
CAUTION
Damage from unsuitable accessories.
The use of accessories, other components, and cables other than those spe-
cified, with the exception of components and cables sold by KaVo as spare parts
for internal components, can increase emissions or reduce the electromagnetic
immunity of the product.
4
Use accessories recommended by KaVo only!
Information about electromagnetic compatibility
NOTE
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electro-
magnetic compatibility of electrical medical devices, we must draw
your attention to the following points:
Medical electrical devices are subject to special precautions concerning the
electromagnetic compatibility and must be installed and operated in accord-
ance with the KaVo assembly instructions.
High-frequency communications devices may interfere with medical electrical
devices.
KaVo does not guarantee the compliance of accessories, cables, and other
components not supplied by KaVo with the EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
Also refer to:
13 Information concerning the electromagnetic compatibility according to EN
IEC 60601-1-2, Page 63