148 Instructions for use Isolette 8000 plus SW 5.n
Service
13.3 Definition of service terminology
Properly trained personnel should routinely inspect the patient compartments for
signs of breakage and should replace assemblies before placing the incubator
into service.
13.4 Inspection
13.4.1 Safety checks
Safety checks are not a substitute for maintenance, which includes the preventive
replacement of wearing parts as specified by the manufacturer.
13.4.1.1 Performing the safety checks
1 Check that the respective instructions for use are present.
2 Perform a functional test of the following functions according to the instructions
for use:
– Holding force of all hand ports
– Incubator operational procedure
– High temperature alarms
3 Inspect the following features:
– Hand ports
–Hood
– Unauthorized probes or modifications to equipment
– Incubator connection to height adjustment trolley
– Movement of height adjustment trolley
Concept Definition
Service All measures (inspection, maintenance, repair)
intended to maintain or restore the functional
integrity of a product
Inspection Measures intended to determine and assess the
current state of a product
Maintenance Regular specified measures intended to maintain
the functional integrity of a product
Repair Measures intended to restore the functional integ-
rity of a product after a failure
Measure Interval Target group
Inspection and safety check
1)
1) Designation applies to the Federal Republic of Germany; corresponds to the "Recurring safety inspection"
in the Federal Republic of Austria.
Every 1 year Service personnel
Verification of the scale According to regulatory
requirements for scales
which must be verified
Officially authorized
specialist personnel
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