Fresenius Medical Care 2008K Operator's Manual page 14

General Warnings
Warning! Bicarbonate and acid concentrates intended for other dialysate delivery machines
will deliver safe dialysate solution only if the machine is set up for them. The selection of
other dialysate concentrate types must be done by a qualified, authorized person. The 2008K
hemodialysis machine can be set up for various concentrate types. Use Table 33 in
Appendix B to ensure that you have compatible concentrates and configurations.
Warning! Acid concentrate products are used as one component in mixing dialysate bath.
These acid products contain chemical compounds that, after mixing, yield acetate (and
citrate in certain products) in the dialysate. (Please refer to the acid concentrate product
labeling for specific acetate/citrate amounts.) After diffusion across the dialyzer membrane,
acetate (and citrate when present) is metabolized by the liver to serum bicarbonate and adds
to the serum bicarbonate that separately results from the diffusion of dialysate bicarbonate
across the dialyzer membrane. During dialysis, the dynamic of diffusion and concentration
gradients prevent serum bicarbonate concentration from exceeding the dialysate bicarbonate
concentration. The bicarbonate concentration of the dialysate is the "bicarbonate" setting on
the dialysis machine, and is the bicarbonate dose prescribed by the physician. On the 2008
series hemodialysis machines, the bicarbonate dose may be set in a range between 20 and 40
milliequivalents per liter, but may be set in different ranges in other machines.
When the dialysis session terminates, acetate (and citrate when present) that has not yet
metabolized may remain in the blood and will be converted to serum bicarbonate after
diffusion ceases, without possibility of diffusion out of the blood. The post dialysis
metabolism of acetate (and citrate when present) could thus briefly increase serum
bicarbonate concentration above the prescribed bicarbonate concentration of the dialysate.
Physicians should consider this possibility in prescribing bicarbonate dose.
Prescription of insufficient bicarbonate may contribute to metabolic acidosis; excessive
bicarbonate may contribute to metabolic alkalosis. Both conditions are associated with poor
patient outcomes, including increased mortality risk.
Warning! Incorrect composition will result if the acid concentrate nozzle is not connected
to the appropriate acid concentrate or the bicarbonate concentrate nozzle is not connected to
the appropriate bicarbonate solution. The acid and bicarbonate concentrates must match
those selected in the Dialysate screen. Patient injury or death may occur if incorrect
dialysate solution is used. Fresenius USA, Inc. recommends the operator use the concentrate
containers provided with the machine. These containers, being of different size and shape,
help to reduce the chances of mismatching the acid and bicarbonate concentrates.
Warning! The operator should always check conductivity and approximate pH of the
dialysate with an independent device prior to initiating treatment and whenever
concentrates are changed during operation.
Warning! Use of an acid concentrate intended for a 1:44 mix ratio in any 1:34
proportioning dialysate delivery machine may result in a dialysate solution with a normal
conductivity but without a physiological buffer. There may be no alarms in this event. Use
of this improper dialysate solution may cause patient injury or death.
Warning
! The machine must be labeled to indicate the type of concentrate for which it is
configured. Check the composition (i.e., Na, Cl, K, Ca, Mg, HCO
solution after the machine is installed or after the machine is modified for different
concentrate types. Check the conductivity and approximate pH of the dialysate solution
with an independent device before initiating dialysis. Improper conductivity or pH could
result in patient injury or death.
14 2008K Hemodialysis Machine Operator's Manual Rev P
) and pH of the dialysate
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