Enraf Nonius Endomed 482, Руководство по эксплуатации

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10.4 Safety and Performance standards
IEC 60601-1
: General requirements for the safety of electrical medical
systems, including Annex 1, national differences for Australia,
Canada and the United States.
Safety class according to IEC 60601-1: class I type BF
IEC 60601-2-5
: Particular requirements for the safety of ultrasonic therapy
equipment.
IEC 60601-2-10 : Particular requirements for the safety of nerve and muscle
stimulators.
: This equipment complies with all requirements of the Medical
Device Directive (93/42/EEC).
Medical device classification : IIa
21 CFR 1050.10
: This equipment complies with all requirements of 21 CFR
1050.10, Performance Standard for Ultrasonic Therapy
devices.
21 CFR 898
: This equipment complies with all requirements of 21 CFR 898,
Performance Standard for electrode lead wires and patient
leads.
10.5 EMC details
Medical electrical devices such as the 4-series are subject to special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and commissioned in accordance with the
EMC advice given in the instructions for use and accompanying documents.
Portable and mobile RF communication systems (e.g. mobile phones) may interfere with medical
electrical 4-series.
The 4-series should only be operated with the original mains cable specified in the list of contents
delivered.
Operating the device with any other mains cable can lead to increased emissions or reduced interference
immunity of the device.
Guidelines and manufacturer's declaration – electromagnetic interference
The 4-series device is intended for operation in an electromagnetic environment as indicated
below. The customer or user of the 4-series unit should ensure that it is operated in such an
environment.
Interference tests Conformity Electromagnetic environment
guideline
RF emissions according to CISPR 11 Group 1 The 4-series device uses RF energy
solely for its internal functioning. Its
RF emission is therefore very low and
it is unlikely that this will cause
interference to neighbouring
electronic 4-series.
RF emissions according to CISPR 11 ClassB The 4-series device is suitable for use
in all installations including those in a
residential environment and those
which are directly connected to the
public mains network which also
supplies buildings which are used for
residential purposes.
Harmonic emissions according to
IEC 61000-3-2 Class B
Voltage fluctuation emissions and
flicker according to IEC 61000-3-3 Conforms