4 Testing and Maintenance
Safety Testing
32
The expected test result is pass: the monitor boots up and displays the startup screen.
Safety Testing
Safety tests are comprised of the following tests performed on the monitoring system:
• protective earth resistance
• equipment leakage current
Safety test requirements are set according to international standards, their national deviations and
specific local requirements. The safety tests detailed in this Service Guide are derived from international
standards but may not be sufficient to meet local requirements. We recommend that you file the results of
safety tests. This may help to identify a problem early particularly if the test results deteriorate over a period
of time.
Each individual piece of equipment of the monitoring system which has its own connection to
mains or
which can be connected or disconnected from mains without the use of a tool must be tested individually.
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 certified 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 user and patient safety. 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 monitor complies with:
IEC60601-1:1988 + A1:1991 + A2:1995 = EN60601-1:1990 +A1:1993 + A2:1995
IEC60601-1-1:2000
For USA, the monitor complies with:
UL60601-1
For Canada, CAN/CSA C22.2#601.1-M90
• Local regulations supersede the testing requirements listed in this chapter.
• If a non-medical electrical device is connected to a medical electrical device, the resulting medical
electrical system must comply with IEC/EN 60601-1-1.
• Perform safety tests as described on the following pages.
Summary of Contents for M8031B
Page 2: ......
Page 22: ...3 Installation 865299 Dimensions 20 865299 19 Display ...
Page 23: ...Dimensions 3 Installation 865299 21 ...
Page 30: ...3 Installation 865299 Connections 865299 28 ...
Page 44: ...4 Testing and Maintenance After Installation Testing or Repair 42 ...
Page 66: ...6 Repair and Disassembly M8033C Backlight Replacement 64 ...
Page 68: ...7 Part Numbers 66 ...
Page 70: ...2 ...