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, readjustments, 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 made at cost. Consult our service station in your place.

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 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 (-4°F - +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.

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