Welch Allyn MicroTymp® 4 Tympanometer User Manual
DIR 80024157 Ver A
Page 46
WEEE (Waste Electrical & Electronic Equipment) Legislation
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PPENDIX
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SE WITH
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MEDICAL
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LECTRICAL
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QUIPMENT
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(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- are met.
The following signal inputs and outputs on the Welch Allyn MicroTymp 4 tympanometer are
electrically isolated to the requirements of IEC 60601-1:
Socket Label
Socket Type
Typical Connection
USB
USB connector
Type B
Computer
RJ6 socket
Supplied printer
These measures are incorporated to reduce any potential hazard associated with the use of
mains-powered equipment connecting to these interfaces.
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 Welch Allyn at the address given on the front of this user manual if advice is required
regarding the use of peripheral equipment.
