Berlin Heart EXCOR Adult, Инструкция по клиническому применению

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Maintenance, Cleaning and Disinfection
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WARNING
18 Maintenance, Cleaning and Disinfection
18.1 Safety Information
Observe the prescribed maintenance intervals. If these warnings are
not heeded, safe and smooth operation is not guaranteed.
Do not conduct service or maintenance work on components that are
actively being used on patients. Otherwise, safe patient care cannot be
guaranteed.
Maintenance on EXCOR Active is performed by the manufacturer or
distributor. Do not perform maintenance or repair work yourself.
18.2 Maintenance
18.2.1 Maintenance Personnel
Inspections by the operator must be performed by suitable, qualified personnel.
18.2.2 Maintenance by the Manufacturer / Distributor
18.2.2.1 Intervals
The maintenance label shows the latest possible date of next maintenance. Active
driving units may require maintenance before that date, depending on the number of
pump cycles performed.
18.2.2.2 Shipment
Place the components inside their intended packaging and send them to the manufac-
turer or distributor. If the original packaging is no longer available, additional packag-
ing can be ordered from the manufacturer.
Component Interval
Driving unit and replace-
ment driving unit Maintenance is to be conducted after one year or 34
million pump cycles, whichever comes first. Five
days before the maintenance interval ends, an
active alarm is emitted.
Manual pump Annually
Flow sensor Every two years
Caddy First after two years, then annually
Tab. 18-1 Intervals - maintenance by the manufacturer