Chapter 2: Important information
2-8 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
2.7 To be observed when working on the device
Further information on installation (see chapter 9 on page 9-1).
Further information on the Technical Safety Checks and maintenance
procedures (see chapter 11 on page 11-1).
Use only original spare parts.
For identifying and ordering spare parts, test equipment, and tools,
always use the electronic spare parts catalog.
Transport and storage (see chapter 10 on page 10-1).
2.8 Expected service life
If the Technical Safety Checks are performed to the full extent specified
and at the prescribed intervals, the safe operation of the device in the
time between these procedures is guaranteed.
In addition, the manufacturer recommends to perform maintenance
procedures in the same time interval to avoid device malfunction due to
wear and tear.
With each Technical Safety Check, the "expected service life"
according to IEC 60601-1 will therefore be prolonged until the next
prescribed Technical Safety Check.
2.9 Duties of the responsible organisation
Requirements The responsible organisaion must ensure that the following
requirements are fulfilled:
– Compliance with the national or local regulations concerning the
installation, operation, use, and maintenance of the device.
– Compliance with the accident prevention regulations.
– Correct and safe condition of the device.
– Permanent availability of the Instructions for Use.
Training and instruction Before the responsible organisation can begin to operate the device,
the individual responsible for the operation must have been instructed
by the manufacturer on how to use the device and must be thoroughly
familiar with the contents of the Instructions for Use.
The device may only be operated by individuals certificated to have
been instructed on the proper operation and handling of the device.
Warning
Start-up, extensions, adjustments, calibrations, maintenance
procedures, modifications, or repairs must only be carried out by the
manufacturer or persons authorised by the manufacturer.
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