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 Amplivox 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 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.
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