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Chapter 9: Installation
9.2
Installation / initial start-up requirements
Charging the built-in
battery
9.3
Important information on initial start-up
For initial start-up only
Environmental conditions
Qualification requirements
of testers
Specifications
Documentation
9-2
Note
To reduce the risk of using the wrong citrate or calcium containers, only
one type of container (container size and concentration) should be used
throughout the hospital or a comparable organisation institution. Save
the same settings for citrate and calcium containers in the setup of all
devices of this organisation institution.
When bringing the device from a cooler to a warmer room, allow approx.
2 hours for the device to adjust to the ambient temperature before
turning the unit on.
On receipt of the device, charge the battery as follows:
– Use the power cable to connect the device to the power supply.
– Actuate the power switch to turn the device on.
– Leave the device on for 10 hours.
The following information is only intended for the initial start-up. This
information is not applicable for restarting devices that have been
removed from service or have temporarily been taken out of service.
Variations in temperature during transport may cause water
condensation on electrical parts. In the event of major variations in
temperature, allow sufficient time for the device to adjust to the ambient
temperature before start-up.
The initial system start-up must only be performed by the
manufacturer's service support organisation or a person authorised by
it.
The initial start-up must only be performed by personnel qualified to
perform the required procedures correctly based on their education,
training, knowledge, and experience. Furthermore, the personnel
performing the checks must be permitted to do so independently and
without outside interference.
Any information on the specifications must be observed.
The initial start-up report and further procedural information are
described in the Service Manual.
Reports are available on request.
The completion of the initial start-up must be entered in the Medical
Device Register.
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
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