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2.5
Brief description
2.6
Intended use
2.6.1
Intended purpose
2.6.2
Specification of use
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
The device enables the performance of extracorporeal blood
purification without additional equipment. Depending on the procedure
used for the extracorporeal blood circuit, it operates and monitors the
dialysate and substituate circuit, plus the plasma circuit.
To operate the device, five keys and a combined rotary selector / key
are located on the monitor. The treatment parameters are entered using
soft keys displayed on a screen, in combination with the rotary selector.
While treatment is in progress, the treatment parameters are displayed.
Roller pumps are used to convey the filtrate, dialysate, substituate, and
plasma, depending on the procedure. Balancing is performed
gravimetrically using scales. Integrated heating elements can be used
to heat the dialysate, substituate, and plasma.
In the extracorporeal blood circuit, the blood is passed through a filter
or an adsorber. The blood can be continuously anticoagulated. An air
bubble detector prevents the infusion of air to the patient. Any
dangerous loss of blood is prevented by a blood leak detector and by
monitoring of the return pressure. The inflow pressure monitoring unit
detects excessive suction at the cannula or at a catheter.
The device is classified as Class II b (MDD) equipment.
The device is designed for the performance of extracorporeal blood
purification (dialysis and apheresis) in clinics and in the area of intensive
care medicine in particular.
Consumables with a service life adapted to the duration of therapy have
to be used for the treatment; see specification in the operator
documentation of the consumables.
The device has been specified by the manufacturer for the following
purposes:
– The treatment of patients, independently of age and weight, while
taking into account the device's specified technical data and the
disposables used (e.g., delivery rates, fill volumes).
– Operation in suitable rooms in professional health care facilities.
Normative and local regulations must be observed.
Chapter 2: Important information
2-3
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