Electrical Safety Tests; Safety Test Overview - GE Voluson E Series Service Manual

Care and Maintenance

10.6 Electrical Safety Tests

10.6.1 Safety Test Overview

Warning
Energy Control and Power Lockout for Voluson E-Series:
When servicing parts of the system where there is exposure to voltage greater than 30 Volts:
1. Follow LOTO (Lockout/Tagout) procedures.
2. Turn off the breaker.
3. Unplug the Voluson E-Series system.
4. Maintain control of the Voluson E-Series system power plug.
5. Wait for at least 30 seconds for capacitors to discharge as there are no test points to verify isolation.
Ultrasound system components may be energized.
The electrical safety tests in this section are based on IEC60601 standard including national deviations 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 including national deviations) which require a
controlled test environment and can place unnecessary stress on the ultrasound system.
These tests may refer to specific safety analyzer equipment as an example. Always refer to the safety
analyzer's user manual that will be used to perform the tests.
Prior to initiating any electrical test, the system must be visually inspected. Perform 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 probes. Inspect the cables and strain relief at each end. Inspect the
probe enclosure and lens for cracks, holes and similar defects.
Caution
For all instructions in this section: In case of using an UPS (uninterruptable power supply) the terms outlet,
wall outlet, AC wall outlet or power outlet refer to the AC wall outlet to which the UPS power input is
connected to. 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
Users must ensure that safety inspections are performed whenever damage is suspected and on a regular
basis in accordance with local authorities and facility procedures. DO NOT use the Voluson E-Series system
or individual probes which fail any portion of the safety test.
Warning
To minimize the risk and to avoid an electric shock, only trained persons are allowed to perform the electric
safety inspections and tests.
Caution
Compare all safety-test results with safety-test results of previously performed safety tests (e.g., last year
ect). In case of unexplainable abrupt changes of safety-test results consult experienced authorized service
personnel or GE for further analysis.
Caution
To avoid electrical shock, the Voluson E-Series system under test must not be connected to other electrical
equipment. Remove all interconnecting cables and wires. The 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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Voluson E-Series Service Manual
5539550APB Revision 6