APPENDIX 4 - USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT
40 MODEL 260 INSTRUCTION FOR USE
APPENDIX 4 - 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 following signal inputs and outputs on the Model 260 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 IEC
60601-1, ed. 3.1.
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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