GE LOGIQ 200, Руководство по контролю качества

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3-1
GE MEDICAL SYSTEMS ULTRASOUND QUALITY ASSURANCE REFERENCE MANUAL
REV 1 2262684-100
CHAPTER 3
LEAKAGE CURRENT CHECKS
3-1 TEST EQUIPMENT REQUIRED
• Leakage Current Meter (Dale 600 or equivalent)
• Outlet Tester (Dale 600 or equivalent)
The electrical safety tests in this section are based on and conform to IEC 601-1.1. Only the checklist
acceptance values for GEMS-AM differ from this standard. They are intended for the electrical safety
evaluation of cord-connected, electrically operated, patient care equipment. If additional information is
needed, refer to the IEC 601-1.1 document.
CAUTION
To avoid electrical shock, the unit under test must not be connected to other
electrical equipment. Remove all interconnecting cables and wires. The unit under
test must not be contacted by users or patients while performing these tests.
CAUTION
Possible risk of infection. Do not handle soiled or contaminated probes and other
components that have been in patient contact. Follow appropriate cleaning and
disinfecting procedures before handling the equipment.
3-2 GEMS Leakage Current Limits
The following limits are summarized for UL 544, UL2601-1, and IEC 601-1 Medical Equipment Safety
Standards. These limits are GEMS standards and in some cases are lower than the above standards listed.
3-2-1 Chassis Leakage Current Limits—Accessible Metal Surfaces
Country Normal condition Open Ground Reverse Polarity Open Neutral
USA N/A 0.3 mA 0.3 mA N/A
Other 0.1 mA 0.5 mA 0.5 mA 0.5 mA
3-2-2 Type BF Applied Part Leakage Current Limit—Non-Conductive (floating) Surface and
Cavity Transducers
Country Normal Condition Open Ground Reverse Polarity Open Neutral *Mains Applied
USA 0.05 mA 0.05 mA 0.05 mA 0.05 mA 0.05 mA
Other 0.1 mA 0.5 mA 0.5 mA 0.5 mA 5.0 mA
* Mains Applied refers to the sink leakage test where mains (supply) voltage is applied to the part to
determine the amount of current that will pass (or sink) to ground if a patient contacted mains voltage.