66 Instructions for use BiliLux
Service
12.2 Overview
This chapter describes the maintenance measures required to maintain the
functional integrity of the medical device. Maintenance measures must be
performed by the personnel responsible.
Properly trained personnel should routinely inspect the device assemblies for
signs of breakage and should replace assemblies before placing the device into
service.
12.3 Definition of service terminology
12.4 Inspection
12.4.1 Inspection due date
Service personnel can enable or disable the display of the due date of the next
inspection. If enabled, this message is displayed after the startup screen. The
interval for the next inspection is one year.
12.4.2 Safety checks
Safety checks are not a substitute for maintenance, which includes the preventive
replacement of wearing parts as specified by the manufacturer.
12.4.2.1 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:
– Device startup
– Electrical and control panel functional check
– Trolley and spring arm functional check (if equipped)
3 Check that the product is in good condition:
– All labels are complete and legible
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 func-
tional integrity of a product
Repair Measures intended to restore the functional integrity of a prod-
uct after a failure
Measure Interval Target group
Inspection and safety checks
Every 1 year Service personnel
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