Instructions for use KaVoLUX 540 LED U / T
8 Safety check - Test instructions | 8.2 Ceiling mounting
Note
With regard to devices that have not been manufactured in accordance with
IEC 60601-1 (DIN EN 60601-1), these requirements can be applied taking
the mandatory safety standards for the production of these devices into con-
sideration.
Note
If several medical electrical devices (ME device) or electrical devices from
several manufacturers combined into a system are connected to the KaVo
dental unit, the manufacturer data contained in the instructions for use for all
products subject to the safety checks must also be noted.
Note
Accessories of ME devices that might impact the safety of the device to be
tested or the measured results must be included in the safety checks.
Note
All tests on accessories included in the safety checks must be documented.
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 es-
sential 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 document.
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 manu-
facturers) 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
connected by the application of a multiple socket outlet.
Note
With ME systems, the person responsible for putting the system together
must employ the necessary measuring parameters and measuring proced-
ures defined in IEC 60601-1 (DIN EN 60601-1).
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