15
1 Important information regarding safe use
55000-00011_002_01 – 1756789 – 2017-09-06
1.10
Combination with other medical devices
Observe the instruction manuals of
combined medical devices
• The system can be combined with medical devices from other manufacturers
(e.g. monitoring systems). The operation of the devices is described in the
relevant instruction manual.
• Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1
may be attached to the system. If a medical device is installed afterwards, the
installation must be performed as specified in IEC 60601-1 and IEC 60601-1-1 or in
accordance with the specifications provided by the manufacturer. Compliance with
this standard must be ensured by the service technician responsible.
• No BF or CF Class application components according to IEC 60601-1 may be
directly connected.
• Devices of third-party manufacturers in the patient environment must have safety
levels equivalent to that of the TruLight 5000/3000 lighting systems.
• Devices of third-party manufacturers outside the patient environment must have
safety levels appropriate for the devices and compliant with the relevant IEC or
ISO safety standards.
1.11
Disposal
The device should be disposed of in accordance with the pertinent national
regulations and at a suitable waste disposal point for the recycling of electrical and
electronic devices.
RoHS conformity
• The device meets the requirements of Directive 2011/65/EU RoHS (restriction of
the use of certain hazardous substances in electrical and electronic devices).
