Operator Responsibility - Fresenius Medical Care multiFiltrate Instructions For Use Manual

2.10 Operator responsibility

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
The manufacturer offers training on this device.
The local service support organisation is available if you have further
questions (see chapter 2.13 on page 2-16).
To enhance treatment quality and patient safety, the manufacturer
recommends following IEC/TR 62653 "Guideline for safe operation of
medical devices used for hemodialysis treatment". The guideline
describes the requirements for using hemodialysis systems safely and
for their intended purpose.
The addresses given herein must be used to notify the manufacturer of
any unexpected operation behavior or other incidents
(see chapter 2.13 on page 2-16).
Warning
Risk of injury due to device defect
If the device has the following defects, the measures given below must
be taken.
Defects on the device:
– Mechanical damage
– Defective power supply connection line
– Other defects
– The device does not respond as expected
– Deterioration in the performance characteristics
Measures:
 An ongoing therapy must be terminated using a reinfusion. If
necessary, perform reinfusion manually (see chapter 5.15 on
page 5-19).
 The device must be taken out of service.
 Inform the responsible organisation or service support without delay.
The following must be observed when entering parameters:
– The parameters entered must be verified by the operator, i.e., the
operator must check that the values entered are correct.
– If this check reveals a deviation between the required parameters
and the parameters displayed on the device, the setting must be
corrected before activating the function.
– The actual values displayed must be compared with the prescribed
target values.
The device may only be operated under the operating conditions
specified by the manufacturer.
Chapter 2: Important information
2-9