Alıntı
BiCart - specification
General Description
The BiCart cartridge is a polypropylene cartridge containing sodium bicarbonate which enables on-line production of liquid bicarbonate concentrate.
When attached to a special holder, water passes through BiCart, thus producing a saturated bicarbonate solution, ready for use. This concentrated solution is then proportioned in the dialysis machine.
Quality Control
Quality control as well as manufacturing procedures for BiCart follow the current Good Manufacturing Practice (GMP) for Pharmaceuticals. As well as European and US legislation for medical devices.
The inspection of components, the process control and finished product testing are rigorous. All documentation and results from tests and inspections are checked and reviewed.
Specification
Units per box
Contents:
10
Each BiCart contains min. 720g (650g) of sodium bicarbonate powder (USP and Eur. Ph. grade).
Capacity:
Together with a suitable acid concentrate each BiCart will yield enough sodium bicarbonate solution to produce 200 I (180 I) of dialysis fluid with a bicarbonate concentration of 34 mmol/l.
Storing: Shelf Life:
Store below +40°C.
Please refer to product label and box.
Duration: Dialysis fluid flow rate
500ml/min 700ml/min
720g BiCart 6h 45min 4h 50min
650g BiCart 6h 4h 20min
Requirements on Acid Concentrate
The acid concentrate must be designed for use with pure bicarbonate concentrate and have a dilution ratio of 1:35 (1+34). As an example, Gambro concentrate 204 can be used. When mixed 1:35 (1+34) this will yield (mmol/l):
103,00 2,00 1,75 0,50
109,50 3,00
Sodium
Potassium
Calcium
Magnesium
Chloride
Acetic acid
Together with the sodium bicarbonate concentrate from the BiCart cartridge the final dialysis fluid will have a sodium concentration of 140 mmol/l and a bicarbonate concentration of 34 mmol/l, at a normal machine setting.
Water Purity
Water for diluting concentrated hemodialysis solutions should be of a suitable quality (AAMI, PH. Eur., BP).
The information herein may be subject to change without further notice, For further information and operating instructions, please refer to the operator's manual.
GAMBRO.
Gambro Lundia AB
Global Marketing
Box 10101, SE-220 10 Lund
Sweden
Tel +46 46 16 90 00
Fax+ 46 46 16 96 97
www.gambro.com
^ %i UUOU The products meet the applicable provisions of Annex I (Essential Requirements) and Annex II (Full quality assurance system) of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
General Description
The BiCart cartridge is a polypropylene cartridge containing sodium bicarbonate which enables on-line production of liquid bicarbonate concentrate.
When attached to a special holder, water passes through BiCart, thus producing a saturated bicarbonate solution, ready for use. This concentrated solution is then proportioned in the dialysis machine.
Quality Control
Quality control as well as manufacturing procedures for BiCart follow the current Good Manufacturing Practice (GMP) for Pharmaceuticals. As well as European and US legislation for medical devices.
The inspection of components, the process control and finished product testing are rigorous. All documentation and results from tests and inspections are checked and reviewed.
Specification
Units per box
Contents:
10
Each BiCart contains min. 720g (650g) of sodium bicarbonate powder (USP and Eur. Ph. grade).
Capacity:
Together with a suitable acid concentrate each BiCart will yield enough sodium bicarbonate solution to produce 200 I (180 I) of dialysis fluid with a bicarbonate concentration of 34 mmol/l.
Storing: Shelf Life:
Store below +40°C.
Please refer to product label and box.
Duration: Dialysis fluid flow rate
500ml/min 700ml/min
720g BiCart 6h 45min 4h 50min
650g BiCart 6h 4h 20min
Requirements on Acid Concentrate
The acid concentrate must be designed for use with pure bicarbonate concentrate and have a dilution ratio of 1:35 (1+34). As an example, Gambro concentrate 204 can be used. When mixed 1:35 (1+34) this will yield (mmol/l):
103,00 2,00 1,75 0,50
109,50 3,00
Sodium
Potassium
Calcium
Magnesium
Chloride
Acetic acid
Together with the sodium bicarbonate concentrate from the BiCart cartridge the final dialysis fluid will have a sodium concentration of 140 mmol/l and a bicarbonate concentration of 34 mmol/l, at a normal machine setting.
Water Purity
Water for diluting concentrated hemodialysis solutions should be of a suitable quality (AAMI, PH. Eur., BP).
The information herein may be subject to change without further notice, For further information and operating instructions, please refer to the operator's manual.
GAMBRO.
Gambro Lundia AB
Global Marketing
Box 10101, SE-220 10 Lund
Sweden
Tel +46 46 16 90 00
Fax+ 46 46 16 96 97
www.gambro.com
^ %i UUOU The products meet the applicable provisions of Annex I (Essential Requirements) and Annex II (Full quality assurance system) of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
