Page 44 OM001-16 Otowave 102 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.
The Otowave 102 tympanometer uses an industry-standard infra-red
means of communication (an IrDA port - as described in Section 7) 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.
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