EDAN C3A User Manual page 9

C3A, C6A, C6A HD Video Colposcope User Manual
7 Accessory equipment connected to the device must be certified according to the
respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and
IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply
with the valid version of the system standard IEC/EN 60601-1. If any question, please
consult our technical service department or your local distributor.
8 Connecting any accessory or equipment to the device makes a medical system. In
that case, additional safety measures should be taken during installation of the
system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
9 For any non-medical electrical equipmentforming part of the system to be used within
the patient environment, additional protective earthing should be applied or the
non-medical electrical equipment should be supplied via a separating transformer
that complies with IEC/EN 60601-1. If no separating transformer or other protective
measure is applied, the non-medical electrical equipment must be used outside the
patient environment, and the system should be tested according to the requirements
of IEC/EN 60601-1.
10 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system. You can refer to the label or silk-screen for the
maximum permitted load.
11 SHOCK HAZARD – Do not connect non-medical electrical equipment, which has
been supplied as a part of the system, directly to the wall outlet when the
non-medical equipment is intended to be supplied via a multiple portable
socket-outlet with a separating transformer.
12 SHOCK HAZARD –Do not connect electrical equipment, which has not been
supplied as a part of the system, to the multiple portable socket-outlet supplying the
system.
13 Multiple portable socket-outlets shall not be placed on the floor. An additional multiple
portable socket-outlet or extension cord shall not be connected to the system.
14 Only accessories supplied by the manufacturer can be used.
15 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the device. The operation
or use of non-approved equipment or accessories with the device is not tested or
supported, and device operation and safety are not guaranteed.
16 Using accessories other than those specified by the manufacturer may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
device.
17 Make sure that all the components and accessories are connected correctly and
checked before powering on.
WARNING
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Safety Guide