Fresenius Medical Care 5008, Operating Instructions Manual

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Chapter 2: Important Information
Fresenius Medical Care 5008 OP 5/09.06 2-3
2.2 Important Information on the System
2.2.1 Brief Description
Dialysis treatments with the hemodialysis system 5008 can be
performed without any additional equipment. The hemodialysis system
controls and monitors the dialysate circuit and the extracorporeal blood
circuit.
The monitor comprises of four keys. All entries are made via a high-
resolution color monitor (touch screen). The current treatment data are
shown on the display.
In the dialysate circuit, product water is heated, degassed, mixed with
hemodialysis concentrate, and delivered to the dialyzer. Inflowing and
outflowing quantities are balanced volumetrically. The pressure at the
dialyzer is adjusted depending on the ultrafiltration rate selected and the
type of dialyzer used.
The blood in the extracorporeal blood circuit is transported through the
dialyzer. The blood can be continuously heparinized. An air bubble
detector prevents infusion of air. Any dangerous loss of blood is
prevented by a blood leak detector, a fluid detector and by monitoring
the venous return pressure. The arterial pressure monitoring unit
detects an aspiration of the needle in the vessel.
The hemodialysis system 5008 is designed for both acetate dialysis and
bicarbonate dialysis. The mixing ratio, the Na
+
concentration and the
bicarbonate concentration may be programmed within certain limits.
The hemodialysis system allows programming of Na and UF profiles.
ISO-UF (ultrafiltration without dialysate flow) may be performed.
The dialysate flow can be adjusted from 100 to 1000 ml/min, in
increments of 100 ml/min. The AutoFlow function automatically
regulates the dialysate flow, depending on the dialyzer type and blood
flow.
The 5008 hemodialysis system reflects the latest state of technology. It
is equipped with all safety systems required for its function and for
patient safety. It complies with the requirements of EN 60601-1 (IEC
601-1). The BPM (optional) complies with the EN 1060-1 standard for
non-invasive sphygmomanometers, Part 1 General Requirements.
The 5008 hemodialysis system is classified as Class II b (MDD)
equipment.