Gynesonics Sonata System, Service Manual

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Chapter 2: Electrical Safety Tests
LS 06311-002US Rev A
16
Chapter 2 Electrical Safety Tests
The electrical safety tests in this section are based on and conform to IEC 62353 and NFPA 99
1
. They
are intended for electrical safety evaluation of cord-connected, electrically operated, patient care
equipment. If additional information is needed, refer to IEC 62353 and NFPA 99 or the
corresponding Handbook.
The tests summarized in Table 2 should be performed at regular intervals. The suggested interval is
annual or consistent with user site policy.
All tests listed in Table 2 can be done with a Safety Analyzer listed in 1.8 or equivalent.
To connect to the Safety Analyzer, use ACCY-014 Patient Lead Grounding Cable.
To connect to the chassis for leakage tests, connect to the Potential Equalization post on the chassis.
Table 2 Routine Electrical Safety Tests
Testing Item
Instructions
and Test
Conditions
Standards Clause Acceptance Criteria
Visual Inspection of
Physical Integrity
§2.1
IEC 62353: Clause 5.2
NFPA 99:2018
10.3.1
Any condition that appears to affect
proper operation or present an
otherwise unsafe condition should
be repaired or replaced.
Safety related markings and labels
should be legible and complete
Sonata System documentation is
available and reflects the current
configuration of the system
Ground Resistance
(PE to Ground)
§2.2
IEC 62353: Clause 5.3.2.2b
NFPA 99:2018
10.3.2
≤ 0. 30 Ω (IEC 62353)
≤ 0. 50 Ω (NFPA 99)
Insulation Resistance
(Mains to PE)
§2.2 IEC 62353: Clause 5.3.3
≥
2 M Ω
Earth Leakage Current
(LN)
§2.3 IEC 60101-1 subclause 8.7.3
≤ 500

A
Earth Leakage Current
(NL)
§2.3 IEC 60101-1 subclause 8.7.3 ≤ 500

A
Touch (Chassis) Current,
§2.3
IEC 62353: Clause 5.3.4.1
NFPA 99:201810.3.3, 10.3.5
≤ 500 μA
Patient Lead Leakage,
Ground switch CLOSED
§2.4
NFPA 99:2018
10.3.6
≤ 100 µA
Patient Lead Leakage, §2.4 IEC 62353: Clause 5.3.4.3
≤ 500 µA
1
IEC 62353, ED 2.0:2014; NFPS
®
99 Health Care Facilities Code Eleventh Edition 2018, §10.3