USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT
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D-0014930-A
– Otowave 102-C Operating Manual
18.
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.
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.
