E-1
E
Electrical Safety Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program.
They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or
the operator. Additional tests may be required according to local regulations.
All tests can be performed by using commercially available safety analyzer test equipment. These procedures assume
the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with
IEC 60601-1 used in Europe, such as Fluke, Metron or Gerb, may require modifications to the procedure. Please follow the
instructions of the analyzer manufacturer.
The electrical safety inspection should be periodically performed per year. The safety analyzer also proves to be an
excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current loads.
E.1
Power Cord Plug
Test Item
Acceptance Criteria
The power plug
The power plug pins
No broken or bent pin. No discolored pins.
The plug body
No physical damage to the plug body.
The strain relief
No physical damage to the strain relief. No plug warmth for device in use.
The power plug
No loose connections.
The power cord
No physical damage to the cord. No deterioration to the cord.
For devices with detachable power cords, inspect the connection at the device.
For devices with non-detachable power cords, inspect the strain relief at the
device.
E.2
Device Enclosure and Accessories
E.2.1
Visual Inspection
Test Item
Acceptance Criteria
The enclosure and accessories
No physical damage to the enclosure and accessories.
No physical damage to meters, switches, connectors, etc.
No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).
E.2.2
Contextual Inspection
Test Item
Acceptance Criteria
The enclosure and accessories
No unusual noises (e.g., a rattle inside the case).
No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes).
No taped notes that may suggest device deficiencies or operator concerns.
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