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TECHNICAL DATA SHEET

BICARBONATE POWDER CARTRIDGE

DESCRIPTION AND INTENDED USE The Bidry/Solucart Plus cartridges contain powdered bicarbonate which the dialysis machine automatically dissolves with hemodialysis-standard purified water to produce a basic concentrated solution. This concentrate can then be used in the formation of the dialysis fluid to perform bicarbonate dialysis treatments. The dialysis fluid restores acid-base balance in the patient by passing solutes to and from the blood through the dialyser membrane.

Cartridges

The Bidry/Solucart Plus bicarbonate cartridges are connected to the dialysis machine with special connectors fitted onto the machine itself: - For perforation systems: Solucart Plus - For Luer-lock connection systems: Bidry The use of Bidry/Solucart Plus cartridges brings considerable advantages, such as:

• Increased product validity compared to the liquid form

• Absence of bacterial proliferation

• Reduced storage volume.

Two sizes of Bidry cartridges are available based on the quantity of dialysis fluid to be produced: 750 g and 950 g. The Solucart Plus cartridges are available in the sizes 750 g and 850 g. The content of the cartridges is in compliance with the monographs of the Official Italian Pharmacopoeia (FUI) and the current European Pharmacopoeia (Eur. Ph.).

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Materials The Bidry container is made of high-density polyethylene. The Bidry bicarbonate powder cartridge comes complete with:

• A double polycarbonate microfilter to prevent the bicarbonate powder from entering the haemodialysis machine

• PVC connection lines, including clamps to interrupt the water/concentrated solution flow from the cartridge inlet/outlet

• A polycarbonate plug-in connector. The Solucart Plus container is made of polypropylene. The Solucart Plus bicarbonate powder cartridge comes complete with a double polypropylene microfilter to prevent the bicarbonate powder from entering the haemodialysis machine. WARNINGS Check the integrity of the protective wrapping before use. Check the integrity of the cartridge before use and do not use the product if it appears damaged. The product must be prescribed by a specialist physician. The device is single-use, non-sterile and pyrogen-free. Use according to the instructions in the machine operator manual. PACKAGING The Bidry/Solucart Plus bicarbonate powder cartridges are available in boxes containing 12 or 10 cartridges, respectively, as indicated in the table. The secondary packaging is made of cardboard. STORAGE AND DISPOSAL CONDITIONS After use, dispose of the device in compliance with the waste disposal regulations in force. Store at a temperature below 40°C. PRODUCT IDENTIFICATION Each Bidry/Solucart Plus cartridge is labelled with the following data:

• Name

• Name and address of the production unit

• Production batch

• Expiry date

INSTRUCTIONS FOR USE Connect the bicarbonate cartridge to the dialysis machine using the special connectors, following the instructions in the machine operator manual. This technical data sheet refers to the following codes:

Cartridge type Code Description Volume Pieces per box

Bidry BSCART003 BIDRY BIC. POWDER CART. 750 G 750 g 12

Bidry BSCART009 BIDRY BIC. POWDER CART. 950 G 950 g 12

Solucart Plus BSCART002 SOLUCART PLUS BIC. CARTRIDGE 750 G . 750 g 10

Solucart Plus BSCART018 SOLUCART PLUS BIC. CARTRIDGE 850 G . 850 g 10

The device has the CE 0123 marking. CND= F040201