Instruction manual

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 conﬁ guration 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 ef-

fects on safety, reliability and performance of the EQUIPMENT only if:

– assembly operations, extensions, re-adjustments, modiﬁ cations 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 deal-

er 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 qualiﬁ ed technical personnel to repair those parts of the EQUIPMENT which

are classiﬁ ed by the manufacturer as repairable.

The use of ACCESSORY equipment not complying with the equivalent safety require-

ments 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 certiﬁ cation of the ACCESSORY has been performed in accor-

dance to the appropriate EN60601-1 and/or EN60601-1-1 harmonized national stan-

dard.

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)

Atmospheric pressure : 50 kPa - 106 kPa

Note : The above transportation environmental conditions indicate the storage environ-

mental conditions during transport.