General Warnings - Fresenius Medical Care 2008K Operator's Manual

General Warnings

This section contains general warnings statements regarding the use and maintenance of the
2008K hemodialysis machine. It is not a complete summary, and additional warning
statements specific to pertinent topics can be found within this manual.
Water
Warning! Connect water inlet according to the specifications for the machine. For further
information, see Appendix B, "Machine Specifications." The correct ionic concentration
and bacterial quality can generally be achieved in the dialysate only with treated water that
meets water quality standards (see Water Quality and Dialysate Quality on page 218 of the
"Machine Specifications" section for more information). Be sure that all specifications are
satisfied. The water source must be monitored periodically to detect fluctuations in water
composition and quality that could have an adverse effect on the patient or dialysate
delivery machine. Particular attention must be taken for chemicals such as aluminum,
chlorine, and chloramine, as these chemicals can cause complications in dialysis patients.
Warning! Comply with all local regulations in respect of separation of devices in the water
supply in case of back siphonage; an air gap must be created between the machine's drain
line and its drain.
Concentrates
Warning! The specific acid and bicarbonate concentrates, including the sodium,
bicarbonate, and electrolyte compositions, must be prescribed by a physician.
Warning! Many concentrate types are available for use in dialysate delivery machines.
Concentrates contain various amounts of dextrose, potassium, calcium, sodium, chloride,
magnesium, and other components. Most concentrates are designed as a two-part system of
acid and bicarbonate solutions which are mixed in the machine with water. Even within the
subgroup of bicarbonate type concentrates, there are at least four methods of compounding
the solutions. Each of these methods requires special calibrations or setups. Certain
methods are not supported. It is mandatory that the acid and bicarbonate types be matched
to each other. Be sure to use compatible solutions, labeling, and setups. These setups
include machine calibration, special adapters for certain concentrate types, correct setting of
concentrate option, and labeling. Failure to use the properly matched solutions and machine
calibrations may allow improper dialysate to be delivered to the patient, resulting in patient
injury or death. Verify composition, conductivity, and pH after converting to a different
type of concentrate.
Warning: Acid concentrate, bicarbonate concentrate, and water must be of the appropriate
quality to ensure safety and performance of the final dialysate are met (see Concentrate
Quality on page 218 of the "Machine Specifications" section for more information).
Warning! Connection to a central acid or bicarbonate feed system requires the installation
of certain mechanical parts. Contact Fresenius USA, Inc. for more information.
2008K Hemodialysis Machine Operator's Manual Rev P
General Warnings
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