BIS VISTA - Leakage Current Checking

SECTION 5 PREVENTIVE MAINTENANCE, CARE AND CLEANING
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5-6
5.2.7 Checking Leakage Current
Leakage current is a primary indicator of electrical shock hazard to personnel making contact
with any exposed outer surface of the equipment. Each BIS VISTA monitor is carefully
checked at the factory to verify that leakage current meets the UL60601-1 and IEC60601-1-1
safety standards.
The BIS VISTA monitor should be checked routinely for leakage current at least
once a year.
Always have the leakage current checked after a saline or blood spill, or immediately after a
major surge in the house electrical system and after every time the monitor case has been
opened.
Keep in mind that liquids such as saline and Ringer’s as well as blood are all excellent
conductors of electricity. Avoid touching any part of the system with wet hands. Always
work with clean, dry hands.
WARNING:
ELECTRICAL SHOCK HAZARD: THE MANUFACTURER’S
INSPECTION OF THIS APPARATUS VERIFIED THAT THE
GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY
CURRENT WERE LESS THAN THE SPECIFIED LIMITS
ESTABLISHED BY THE APPLICABLE SAFETY STANDARDS. AS
A MATTER OF SAFE PRACTICE, THE INSTITUTION SHOULD
CONDUCT PERIODIC TESTS TO VERIFY THESE CURRENTS.
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR
SOLUTIONS OCCURS, RE-TEST BEFORE FURTHER USE.
The BIS VISTA Monitoring unit does not contain a Protective Earth Stud (GND Stud) .
Since the exposed metal parts on the rear of the BIS VISTA Monitor (Communication serial
port and USB ports) are separated from live parts by double insulation, a ground continuity
test does not apply to these parts. The components of the BIS VISTA Monitor that are
connected to protective earth are contained within its enclosure and are not accessible to the
user of the equipment. However, as stated in the operating manual, an enclosure leakage
current test should be performed on the exposed metal parts and should be checked
periodically to ensure that the integrity of the equipment’s insulation system is maintained.
The leakage current test should include measurement of ground wire leakage, enclosure
leakage, and patient leakage.
Ground wire leakage typically can be performed automatically by connecting the A/C power
cord of the BIS VISTA Monitor into a safety tester. The enclosure leakage may be measured
by any safety test equipment that is capable of connecting to isolated conductive parts and
measuring the current from those parts to earth. The patient connection terminals of many
safety testers can be used for this purpose. The patient leakage current can be measured by
connecting the patient connection terminals of a safety tester to the patient input connection
(the PIC) of the BISx.