Xenios Holder for Backup Pump Drive Mode D'emploi page 9

1. INTRODUCTION
The purpose of these Instructions for Use is to instruct qualified medical
staff in the function and maintenance of the Holder for Backup Pump
Drive . All users of the Holder for Backup Pump Drive must have read these
Instructions for Use prior to using this holder . The Holder for Backup
Pump Drive is a class I device according to the Regulation (EU) 2017/745
on medical devices (MDR) .
1.1. INTENDED PURPOSE
The Holder for Backup Pump Drive is a non-therapeutic part of the Xenios
System (deltastream MDC console, iLA activve console, i-cor console or
Xenios console) . It is intended to only be used as a passive IV pole mount
for the console backup pump drive . The Holder for Backup Pump Drive is
used to store the backup pump drive . The backup pump drive is put onto
the holder and this can be mounted at a trolley pole in operating room
(OR) or intensive care unit (ICU) environment .
1.2. INDICATIONS FOR USE
The Holder for Backup Pump Drive in combination with the trolley can be
used to provide a standby backup pump drive during the treatment of
neonates, pediatric and adult patients .
1.3. TARGET USER GROUPS
The Holder for Backup Pump Drive may only be used by qualified medical
staff required to work with it .
1.4. CONTRAINDICATIONS
There are no known contraindications, complications or interactions .
Note: Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient
is established .
I N T R O D U C T I O N
EN
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