Zimmer CryoMini, Руководство по эксплуатации

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EMC Manufacturer’s Declaration
16.
Medical electrical devices, such as Cryo
Mini , are subject to special precautionary measures with regard to EMC
(electromagnetic compatibility) and must be installed and put into service in accordance with the EMC instructions
contained in the operating instructions or the accompanying papers.
Portable and mobile HF communication devices (e.g. mobile telephones, cellphones) can influence medical electrical
devices.
Cryo
Mini may be operated only with the original parts stated in the list of the scope of supply and accessories. Operation
of the device with other parts can lead to increased emissions or reduced interference immunity of the device!
Guidance and manufacturer’s declaration – Electromagnetic emissions
The Cryo Mini device is intended for use in the electromagnetic environment specified below. The customer or the
user of the Cryo Mini device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - Guidance
RF emissions to CISPR 11 Group 1 The Cryo Mini device uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions to CISPR 11 Class B The Cryo Mini device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic emissions to IEC 61000-3-2 Class A
Voltage fluctuations / flicker emissions to
IEC 61000-3-3
Complies
The device may not be used directly next to other devices or arranged stacked with other devices. If operation is
required close to other devices or stacked with other devices, the device should be observed to check its operation in
accordance with the regulations in this used arrangement.