Welch Allyn Electrosurgical Unit - User Manual - Manual (Page 19)

XI. PERIODIC SAFETY CHECKS
A qualified person, who has had adequate training, knowledge and practical perfor-
mance must perform the following safety checks at least every 24 months.
• Inspect the equipment and accessories for mechanical and functional damage.
• Inspect the relevant safety labels for legibility.
• Inspect the fuse to verify compliance with rated current and breaking charac-
teristics.
• Inspect acoustical and visual alarms/displays.
• Verify that the device functions properly as described in the instructions for use.
• Verify that the device shuts down the applied part circuit if the neutral electrode
is disconnected.
• Test the protection earth resistance according to IEC 601-1/1988: Limit 0.2 ohm.
• Check that the output power is within tolerance versus the output control set-
ting at a specified load resistance.
• Check the power output at full and half setting of the output control over the
range of load resistance as specified in the instructions for use (max. deviation
is ± 20%).
• Test the enclosure leakage current according to IEC 601-1/1988: Limit 100µA.
• Test the leakage current according to IEC 601-1/1988: Limit 100µA (BF).
• Test the patient leakage current under single fault condition with main voltage
on the applied part according to IEC 601-1/1988: Limit: 5mA (BF).
The leakage current should never exceed the limit. Record the data in an equipment
log. If the device is not functioning properly or fails any of the above tests, contact
Welch Allyn Customer Service at 1-800-535-6663 for possible unit repair.
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Electrosurgical Unit • Instruction Manual