GE
D
IRECTION
5573152-100, R
EV
. 2
LOGIQ E9 S
ERVICE
M
ANUAL
Chapter 10 Care & Maintenance
10 - 13
10-7-2
Safety test overview
The electrical safety tests in this section are based on NFPA 99 Standard for Health Care Facilities and
IEC 62353 Medical electrical equipment – Recurrent test and test after repair of medical electrical
equipment. These standards provide guidance on evaluating electrical safety of medical devices which
are placed into service and are intended for use in planned maintenance (PM) or testing following
service or repair activities. They differ somewhat from the standards that are used for design verification
and manufacturing tests (e.g., IEC 60601-1 and UL 60601-1) which require a controlled test
environment and can place unnecessary stress on the Ultrasound system.
These tests may refer to particular safety analyzer equipment as an example. Always consult the
manufacturer’s user manual of the Safety Analyzer that will be used to perform the tests.
Prior to initiating any electrical test, the Ultrasound system must be visually inspected. Perform the
following visual checks:
•
Check for missing or loose enclosure covers that could allow access to internal live parts.
•
Examine the mains cord, mains plug and appliance inlet for damaged insulation and adequacy of
strain relief and cable clamps.
•
Locate and examine all associated transducers. Inspect the cables and strain relief at each end.
Inspect the transducer enclosure and lens for cracks, holes and similar defects.
Equipment users must ensure that safety inspections are performed whenever damage is
suspected and at least every 12 months in accordance with local authorities and facility
procedures. Do not use the Ultrasound system or individual probes which fail any portion of the
safety test.
NOTE:
For all instructions in the “Electrical safety tests” section in case of using a UPS (uninterruptible
power supply) the terms outlet, wall outlet, AC wall outlet and power outlet refer to the AC power
outlet of the UPS. In case of further available AC (or DC) power outlets at the same used UPS,
these must remain unused i.e. not connected to any other devices.
WARNING
WARNING
To minimize risk of electric shock, only trained persons are allowed to perform the
electrical safety inspections and tests.
CAUTION
To avoid electrical shock, the Ultrasound system under test MUST NOT be connected to other
electrical equipment. Remove all interconnecting cables and wires. The Ultrasound system
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.
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