KaVo KaVoLUX 540 LED U, Инструкции техника

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Technician's instructions KaVoLUX 540 LED U / T
11 Safety checks - Test instructions | 11.2 Ceiling mounting
Note
If the unit comprises several electrical devices or electrical devices from several
manufacturers that are connected to a system in connection with the KaVo dental
unit, the manufacturer data contained in the instructions for use for all products sub-
ject to safety controls must also be observed.
Note
Accessories to ME devices that could have an impact on the safety of the device to
be tested or the measured results must be included in the safety checks.
Note
All tests concerning the included safety checks of accessories must be docu-
mented.
Note
Furthermore, the manufacturer data contained in the instructions for use must be
adhered to in all products to be tested and inspected.
Note
KaVo offers a medical device book for keeping an inventory and recording essential
master data on the medical device. The medical device book is only available in
German (Mat. no. 0.789.0480).
Note
The following tests and measurements must be documented, for example in the
medical device book. We recommend using the templates at the end of the docu-
ment.
Note
The tests must be performed in the order specified by the manufacturer!
Notes concerning medical electrical systems
Note
An ME System is the combination of individual devices (as defined by manufactur-
ers) that must meet the following conditions:
▶ At least one of these devices must be a medical electrical device.
▶ The devices must be functionally connected or at least they should be connec-
ted by the application of a multiple socket outlet.
Note
With ME systems, the person responsible for putting the system together must em-
ploy the necessary measuring parameters and measuring procedures defined in
IEC 60601-1 (DIN EN 60601-1).
Note
Each individual device in an ME system, which has a separate connection to the
power supply mains, or which can be connected to or separated from the power
supply mains without the aid of a tool, must be checked individually. Moreover, the
ME system must be checked as one unit to avoid the situation, in which the „aging“
of individual devices lead to unacceptable values in sum.
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