Hill-Rom Trumpf Medical TruLight 1000, Инструкция по эксплуатации

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1 Important information regarding safe use
55000-00012_002_01 – 1695233 – 25/01/2018
1.8.1 Ambient conditions for operation
• Ambient temperature: 10 °C to 40 °C;
• Relative humidity: 30 % to 75 %;
• Air pressure: 700 hPa to 1060 hPa;
• Operating height up to 3000 m above sea level.
1.8.2 Ambient conditions for storage
• Ambient temperature: -15 °C to 60 °C;
• Relative humidity: 5 % to 95 %;
• Air pressure: 500 hPa to 1060 hPa
1.9 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 subsequently,
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™ 1000 examination light.
• 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.
1.10 Disposal
The device must be disposed of in accordance with the requirements of directive
WEEE II 2012 / 19 / EU and relevant national regulations 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).