7 Testing and Maintenance
60
Warnings, Cautions, and Safety Precautions
• These tests are well established procedures of detecting abnormalities that if undetected, could
result in danger to either the patient or the operator.
• Disconnect the device under test from the patient before performing safety tests.
• Disconnect the device under test from mains before performing safety tests. If this is not possible,
ensure that the performance of these tests does not result in danger to the safety analyzer operator,
patients, or other individuals.
• Test equipment (for example, a Safety Analyzer) is required to perform the safety tests. Please refer
to Annex C of IEC/EN 62353 for exact requirements for the measurement equipment, and for
measurement circuits for protective earth resistance, and leakage currents. Refer to the
documentation that accompanies the test equipment. Only skilled technicians should perform
safety testing.
• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step to maintain approval agency status. You can also use the Safety
Analyzer as a troubleshooting tool to detect abnormalities of line voltage, and grounding plus total
current loads.
• During safety testing, mains voltage and electrical currents are applied to the device under test.
Ensure that there are no open electrical conductive parts during the performance of these tests.
Avoid that users, patients, or other individuals come into contact with touch voltage.
• For Europe and Asia/Pacific, the fetal monitor complies with: IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010
• For USA, the fetal monitor complies with: ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010
• For Canada, the fetal monitor complies with: CAN/CSA C22.2#60601-1-08
• Local regulations supersede the testing requirements listed in this chapter.
• If a non-medical device is connected to the medical electrical device during an installation, the
resulting medical electrical system must comply with IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010.
• Perform safety tests as described on the following pages.
Electrical Isolation Diagram
This diagram gives an overview of the electrical isolation of the monitor. Accessible metal parts are
identified (see arrows).
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