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[email protected] | +49 921 150845-0
15
Maintenance
15.1
Legal basis
The Medical Device Regulation (EU) 2017/745 (MDR) as well as national laws and regulations require
operators of medical devices to ensure a safe operating condition of the medical device during the
entire period of use.
15.2
Maintenance intervals
As a requirement of the Medical Device Operator Ordinance §4 (Maintenance), a thorough visual
inspection (1), a functional test (2) and a current leakage test (3) must be performed in accordance
with DIN EN 62353:2015-10 after the medical device has been in operation for at least two years.
(1)
During the visual inspection, particular attention must be paid to the following points:
•
tight fit of all screw connections
•
mobility of the pivot points
•
Checking the power supply cable for pinching or shearing points
•
check of the strain relief of the power supply line
(2)
During the functional test, special attention shall be paid to the following points:
•
Function of all electrically operated movements
•
Fully extend and retract all motors on the nursing bed (without mattress; without patient)
until they switch off by themselves. (Limit switches in the motors must switch off with an
audible click).
•
Functionality of the brakes
•
Mobility and function of the side rails
•
Mobility of the triggers
•
Check of the hand switch
Functional tests and current leakage tests may only be carried out by ISKO specialist personnel or by
persons authorized and trained by ISKO with comprehensive product knowledge.
15.3
Spare parts
All spare parts for this medical device must be ordered from IKSO KOCH GmbH, stating the serial
number, order number and article number (these can be found on the type plate attached to the
medical device).
To ensure that the functional safety and any warranty claims remain valid, only original ISKO KOCH
GmbH parts are to be used for the spare parts.
ISKO KOCH GmbH
Egerländer Straße 28
95448 Bayreuth
Tel.: +49(0)921/150845-0 (Monday
–
Thursday 8:00
–
17:00 pm & Friday 8:00
–
16:00 pm)
Fax: +49(0)921/150845-45
E-Mail: [email protected]
