Electrical safety testing
Welch Allyn recommends performing ground continuity, leakage current, and dielectric
strength tests
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when replacing the power supply or primary wiring according to EN/IEC
60601-1 - Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance or EN/IEC 62353 - Medical Electrical Equipment - Recurrent
Test and Test After Repair of Medical Electrical Equipment.
Due to the variability of test equipment in the field, Welch Allyn does not include specific
instructions to perform electrical safety tests. When performing electrical safety tests,
refer to your test equipment manuals for detailed instruction. The following table
provides connections and test limits to assist you in performing these tests.
Test Limits
Ground continuity Ground continuity from EP stud* (equipotential terminal) to the Gnd pin of the
IEC power connector shall be no greater than 0.1 ohms.
Leakage current Leakage current shall be less than 300 µA from EP stud* to mains (Line and
Neutral pins of the IEC power connector).
Dielectric strength Dielectric strength shall be 1.8 kVAC EP stud* to IEC mains (Line and Neutral
pins of the IEC power connector).
* To locate the equipotential terminal, see “Controls, indicators, and connectors.”
Ground stud connector
This device is equipped with a ground stud (equipotential terminal) for electrical safety
testing, and to connect a potential equalization conductor. To ensure use of the proper
connector for safety testing, the ground stud is recessed into the system’s housing. Do
not use “alligator” style clamps or connectors. The mating electrical connector requires
self assembly by crimping it to appropriate connecting leads.
The mating connector (Type POAG-KBT6DIN, order number 15.0010) consists of the
right-angled socket and insulator, as shown in the next figure. You can purchase the
mating connector and the crimping pliers from the manufacturer, Multi-Contact (
http://
www.multi-contact.com).
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Perform this test only if there is a reason to doubt the integrity of the electrical insulation (e.g. multiple
trips of a residual-current device or liquid ingress of a saline solution). If you determine this test should
be performed, return the device to Welch Allyn for service.
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