AmpliVox Otowave 102, Руководство по эксплуатации

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USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT
36
D-0115690-C (OM001)
– Otowave 102 Operating Manual
19. USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT
Any person who connects external equipment to signal input, signal output or other connectors has
created a medical electrical system and is therefore responsible for the system complying with the
requirements of clause 16 of IEC 60601-1:2005
(General requirements for basic safety and essential
performance).
If connections are made to standard equipment such as printers and computers, special precautions
must be taken in order to maintain medical safety. The following notes are provided for guidance in
making such connections to ensure that the general requirements of clause 16 of IEC 60601-1:2005
are met.
The Otowave 102 tympanometer uses an industry-standard infra-red means of communication (an
IrDA port) in order to reduce any potential hazard associated with the use of mains-powered
equipment connecting to this interface.
External equipment intended for connection to signal input, signal output or other connectors, shall
comply with the relevant IEC or international standards (e.g. IEC 60950, CISPR 22 & CISPR 24 for
IT equipment, and the IEC 60601 series for medical electrical equipment).
Equipment not complying with IEC 60601 shall be kept outside the patient environment, as defined
in IEC 60601-1:2005 (at least 1.5m from the patient).
The operator must not touch the connected equipment and the patient at the same time as this would
result in an unacceptable hazard.
Refer to Diagrams 1 & 2 below for typical configurations of connected peripheral equipment.
Refer to Amplivox Limited at the address given on the front of this user manual if advice is required
regarding the use of peripheral equipment.