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To ensure reliable operation and reliable results:
• Only human blood samples should be analyzed
• Only original Erba Lachema reagents should be used
• Required maintenance (user and service level) should be performed as
recommended in this Manual
• Only Erba Lachema certified service personnel should perform service
actions
• Only original Erba Lachema service materials and spare parts should be
used
Original reagents and service materials and spare parts are available from Erba
Lachema.
Only Erba Lachema certified service personnel that have successfully completed
the ‘Erba Lachema ELite 5 Service Training program are qualified to service the
‘ELite 5’ analyzer.
Before operating the ‘ELite 5’ analyzer, all operators should complete the ‘Erba
Lachema ELite 5 Operator Training’ program. This program is offered by Erba
Lachema or by Erba Lachema certified service personnel.
Replacement materials or spare parts (tubes, valves, etc.) which might have been in
contact with human blood or reagents should be handled as a potentially
biologically hazardous and chemically dangerous material. All applicable laws and
regulations must be observed in the handling and disposal of these materials.
The ‘ELite 5’ is designed for laboratory operation. Mobile operation is not supported.
Operate ‘ELite 5’ within the ambient temperature range described in section 1.4.
The IVD equipment complies with the emission and immunity requirements
described in relevant part of the IEC 61326 series.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to reduce the interference.
Electromagnetic environment should be evaluated prior to operation of the device.
This analyzer contains electronic components. Please handle electronic
waste adhering to local or federal regulations.
1.4 Environmental Factors
Operate the ‘ELite 5’ analyzer at the ambient temperature within the range of 15-30°C
(59-86 °F) and a relative humidity range of 10% - 80%. The optimum operating temperature
is 25°C (~77°F).
Avoid exposing the ‘ELite 5’ analyzer to direct sunlight or to extreme high or low
temperatures. If the ‘ELite 5’ analyzer was subjected to extreme temperatures during
shipment or storage, the analyzer must be placed for at least one hour in a room whose
temperature is within the operational range before installation or use.
Reagents should be stored within the temperature range of 15-30°C (59-86 °F).
The analyzer should be placed in a well-ventilated location.
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