Relevant Instructions Before Initial Start-Up

The following points must be strictly observed to assure safe operation of the hemodia-lysis machine:

● Electric installation

– The national standards and regulations (e.g. in Germany VDE 0107) are to be observed when connecting the machine to the local power supply system.

– The use of machines of safety classification I, the quality grade of the protective conductor of the electric installation represents an essential factor. In many countries, pertinent regulations have been specified by national authorities, which must be adhered to.

– If the power cord needs to be replaced, use only the original power cord listed in the spare parts catalog.

– Connect the equipotential bonding to the rear of the machine, if this is required by the legal regulations of the place of installation (e.g. according to VDE 0107 in rooms of application group 2) or special applications (e.g. according to VDE 0753 relating to intracardiac surgery).

Caution

When using central venous catheters it is imperative that the potential equillisa-tion be connected.

With this special type of application all other applied parts (other medical products) must be of the CF type (isolated applied parts that are approved for use on the heart).

Apart from this, applied parts of the CF type (e.g. defibrilators) where the patient currents exceed the maximum allowable CF patient leakage currents may not be used.

– If additional devices, which are not included in the accessories, are connected to the hemodialysis machine, there will be the danger of exceeding the permissible leakage currents.

– Do not operate machines or devices, radiating electromagnetic waves (e.g. walkie-talkies, wireless phones, wireless CB transmitting sets), in the vicinity of running hemodialysis machines. The use of this equipment may cause malfunctions in the respective hemodialysis machine.

● Batteries

Servicing the built-in batteries:

Upon receipt of the hemodialysis machine, the batteries must be charged as follows:

– Connect the machine to the external power supply by means of the power cord.

– Then turn the machine on for approx. 10 hours.

If the machine is not used, this procedure should be repeated every six months.

When using the DIASAFE^®plusplusplusplusplus attention should be given to the points listed below with regard to the quality of product water, concentrate and dialysate:

Caution

Use only reverse osmosis water.

Always ensure that both product water and dialysate meet the applicable standard (see below).

For microbiologic quality standards / recommendations refer to the table below.

General notes

The microbiologic purity of dialysate prepared in the dialysis center is of critical importance.

Product water quality

The „European Pharmacopoeia“ (1997) lists maximum limits for chemical and microbiological quality.

Modern reverse osmosis units and the appropriate design of water storage and delivery systems (e.g. short distribution loops avoiding stagnant flow zones) enable compliance with this standard.

Concentrate quality

While acid concentrate may be considered bacteriostatic, bicarbonate concentrate is an ideal nutrient medium for microorganisms. The use of sterile or microorganism-poor concentrates is recommended. On-line dry concentrates (bibag^®) aid the preparation of dialysate with high microbiological quality. The use of residues from open canisters and the preparation of bicarbo-nate concentrate in the dialysis centre are not recommended. Central delivery systems for concentrate or dialysate must meet high hygienic standards and demand regular inspection.

● DIASAFE^®plusplusplusplusplus (option) water supply

● Water supply

– Only water, which is suitable for hemodialysis, should be used for operating the hemodialysis machine. The quality of the water should fulfill the AAMI regulations for hemodialysis systems, RD5, 1981, part 3.2.

– The ranges of the following parameters are specified in Chapter 1.11 Technical Data: water inlet pressure, supply pressure of the dialysate concentrate, temperature, and flow rates, which are required for operating the hemodialysis machine.

– The national rules and regulations with regard to the prevention of reverse flow into the water supply network and the air gap between drain connection and sewage connection must be observed when installing and operating the machine (e.g. in Germany VDE 0753, part 4). For further information refer to Chapter 1.11 Technical Data.

Dialysate quality

The DIASAFE^®plus removes bacteria and endotoxins from dialysate thus enabling the preparation of ultrapure dialysate.

Even when using the DIASAFE^®plus, it must still be ensured that the microbiological quality standards are complied with.

Microbiological quality standards/recommendations

Product Concentrate Dialysate High-purity

water (not filtered) dialysate

Microbial <100 <1000 <1000 <1

counts (in CFU/ml)

Endotoxins <0.25 <1 <1 <0.03

(in IU/ml)

CFU: Colony-Forming Units IU: International Units

● Functional checks

– Prior to each treatment, the prescribed functional checks must be performed. (See Chapter 2.8.1 Functional Checks Prior to Each Dialysis Treatment.)

● Important documents

– On request, circuit diagrams, descriptions, spare parts lists, and other documents are made available by the manufacturer. These are intended to support trained personnel in servicing and repairing the machine.

– The following is also available on request:

– Test procedures to be used for proving the effectiveness of sterilization or disinfection.

– Data on the recirculation share of blood flow in the extracorporeal circuit to be expected when using the recommended line sets, dialyzers, and puncture cannulae and/or cath-eters.

Note

The machine may only be used as specified in the machine documentation.

Only under these conditions will the manufacturer consider himself responsible for any effects on the safety, the reliability, and the performance of the machine.

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