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SAFETY TECHNICAL CHECKS
Periods: According to the recommendations of the manufacturer of medical device.
Scope: a) Visual check
Housing, cables, operator controls, readout device ( displays, LED etc.), labels,
accessories, instruction manual.
b) Function test
Performance check acc. instruction manual, also unity and applicability of set
and accessory test.
c) Electrical check
Safety electrical test of the configuration in accordance with EN60601-1.
“ In the interest of safety, avoid the handling of liquids beside the set.”
RESPONSIBILITY OF THE MANUFACTURER
The manufacturer, assembler, installer or importer considers himself responsible for the
effects on safety, reliability and performance of the EQUIPMENT only if:
– assembly operations, extensions, re-adjustments, modifications or repairs are carried out
by persons authorized by him, and
– the electrical installation of the relevant room complies with the IEC requirements
– the EQUIPMENT is used in accordance with the instructions for use.
• Any service after expiration of the warranty period will be chargeable. Consult your dealer
for advice.
TECHNICAL DESCRIPTION
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 ap-
propriately 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. Consider-
ation 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 accor-
dance 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 (-4°F - +140°F)
Humidity : 90%RH or less at 40°C (104°F)
Note : The above transportation environmental conditions indicate the storage environ-
mental conditions during transport.
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