4
SAFETY CHECKS
Periods:
According to the recommendations of the manufacturer of the medical device.
Scope:
a) Visual inspection
Housing, leads, controls, displays, labels/ markings, accessories, operation manual.
b) Function test
Testing of functions (according to operation manual) as well as compatibility and usability of device
and accessories.
c) Electrical test
Testing of electrical safety of the system according to EN60601-1.
High humidity or dust
Avoid locations with high humidity and dust in order to avoid malfunctioning of the device.
Also avoid locations subject to corrosive gasses and smoke.
Heat
Direct sunlight, heaters or other heat sources may deform the housing and subsequently cause malfunctioning.
TECHNICAL DESCRIPTIONS
The supplier will make available on request such circuit diagrams, component part lists, descriptions, calibration instructions or
other information which will assist the USER's appropriately qualified technical personnel to repair those parts of the
EQUIPMENT which are classified by the manufacturer as repairable.
The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a
reduced level of safety of the resulting system.
Consideration relating to the choice shall include:
- use of the accessory in the PATIENT VICINITY
- evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate EN60601-1
and/or EN60601-1-1 harmonized national standard.
The transportation and storage environmental conditions are :
Temperature : -20
°
C - +60
°
C (-4F
°
- +140
°
F)
Humidity : 90%RH or less at 40
°
C (104
°
F)
Note : The above transportation environmental conditions indicate the storage environmental conditions during transport.
SAFETY PRECAUTIONS
