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D-0126050 rev 1 - 270+ Operating Manual
9. APPENDIX A – 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).
Please note that if connections are made to standard equipment like printers and networks, 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 following signal inputs and outputs on the Model 270+ audiometer are electrically isolated to the
requirements of IEC 60601-1 in order to reduce any potential hazard associated with the use of mains-powered
equipment connected to these inputs and outputs:
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 (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 to 5 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.
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