Combination With Other Medical Products - Stryker ENT Bedienungsanleitung

1. Ensure that the product and any other electrical devices used in combination with the
product are connected to the potential equalization (equipotential).
WARNING
Before connecting the power cable to a power outlet, make sure that the correct voltage
(100-240 V~ /50/60 Hz) is provided, and that the power cables are clean, dry, and undam-
aged.
2. Connect the device to the power grid with the supplied power cable.
WARNING
– When using a multi-outlet power strip to connect the device to the power grid, make
sure that the multi-outlet power strip conforms to the requirements of IEC 60601-1.
– When installing the cable, take care to position the cable such that the operator or pa-
tient is not at risk of tripping over it.
CAUTION
To completely detach the device from the power grid, make sure to disconnect the power
cable from the power outlet or detach the device from the power grid in another appropriate
manner.
Note: Make sure that the Electromagnetic Navigation Unit and all installed electrical
devices used in combination with it are installed in such that it is easy to disconnect
them from the power grid.

5.7. Combination With Other Medical Products

In combination with other medical devices, safety can only be ensured if the intended use
and the interface specifications allow for it. Refer and adhere to the appropriate manual
while using combined medical devices.
A connected camera unit for an endoscope systems must be in accordance with IEC 60601-1
and provide at least 2 MOPP when connected to the camera system.
When connecting a light source for the endoscope system it must fulfill IEC 60601-1 and
provide at least 2 MOPP towards the patient.
Any connected monitor must be in accordance with IEC 60950-1.
All combined devices must be in accordance with the electrical safety standard IEC 60601-1.
WARNING
– Use only the accessories and spare parts listed in the manual in combination with the
product. The latest versions of all user manuals as well as the intended uses of all prod-
uct components must be respected and observed.
– The installation of the product, including configuration settings, must be conducted by
an authorized and trained expert.
– To prevent interferences and product malfunction, only connect a USB accessory to the
unit which has been tested and authorized by Stryker.
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