GE Giraffe OmniBed Carestation CS1, Руководство по обслуживанию

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Chapter 3: Calibration and Maintenance
Electrical Safety Tests
3-10 Service Manual
Due to the nature of this medical device, leakage current testing as defined in IEC 60601-1 is recommended.
Use of the direct method of leakage current test as defined in IEC 62353 is an acceptable substitution. Due
to the design of this medical device use of the alternative method and differential method as defined in IEC
62353 is not recommended.
Follow the operating instructions supplied by the manufacturer of the electrical safety analyzer to verify the
following:
3.7.1 Ground
1. Measure the resistance between the ground pin on the line cord plug and exposed metal of the
electronic enclosure. The ground resistance must be less than 0.2 Ohms.
2. Measure the resistance between the ground pin on the line cord plug and ground pin on the appliance
outlet connectors. The ground resistance must be less than 0.1 Ohms.
3. If an approved medical device has been connected to the outlet of the device, measure the resistance
between the ground pin on the line cord plug and identified ground test point of the approved medical
device (see device’s manual). The ground resistance must be less than 0.2 Ohms.
3.7.2 Earth Leakage and Chassis Leakage Current
Note: Wait 30 seconds after powering on before taking readings to ensure device has completed all self-
tests and all power relays are closed.
For 100 VAC and 115 VAC rated devices:
In normal condition and in all possible operating modes the leakage current shall be less than 300
microamperes.
If required by local ordinances, in single fault condition and in all possible operating modes the leakage
current shall be less than 500 microamperes.
For 220-230-240 VAC rated devices:
In normal condition and in all possible operating modes the leakage current shall be less than 500
microamperes.
If required by local ordinances, in single fault condition and in all possible operating modes the leakage
current shall be less than 1000 microamperes.
3.7.3 Leakage Current
Isolation of the applied parts is performed by insulation in the patient temperature probe and the in-bed
scale. If so desired, the patient temperature probe can be tested by wrapping in foil or submerging in
normal saline 6 inches (15 cm) of the part of the probe that attaches to the patient. Measurements shall be
taken from the conducting medium. If present, the in-bed scale can be tested by connection to the top tray
mount screws.
Note: Wait 30 seconds after powering on before taking readings to ensure device has completed all self-
tests and all power relays are closed.
For AC lead leakage current:
In normal condition in all possible operating modes the patient lead leakage current shall be less than
100 microamperes.