Baxter PRISMAFLEX System M100 Set

Description

The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit in providing
continuous fluid management and renal replacement therapies. The system is intended for patients who
have acute renal failure, fluid overload, or both.
This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered via the PRISMAFLEX Set must be prescribed by a physician. The size,
weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully
evaluated by the prescribing physician before each treatment.
The pediatric use of the PRISMAFLEX M60 Set should be restricted to children with a body
weight greater than 11 kg (24 lb) with respect to extracorporeal blood volume.
The M60 hemofilter sets are designed for prescription flexibility on the PRISMAFLEX
System. Both set configurations are created with the AN 69 Dialyzer Membrane and can be used to
perform all CRRT therapies (SCUF, CVVH, CVVHD and CVVHDF).

Weight – 800 g
Overall dimensions – 27 x 22 x 9 cm
Blood volume in set ± 10 % – 152 ml
Minimal patient weight – 30 Kg

Materials
• AN 69 HF hollow fiber: Acrylonitrile and
sodium methallyl sulfonate copolymer
• Filter housing and headers: Polycarbonate
• Filter potting compound: Polyurethane
• Tubing material: plasticized polyvinyl chloride (PVC)
• Cartridge: PETG
• Sterilization mode: EtO (ethylene oxide)
• Not made with natural rubber latex
• Contains DEHP, which may pose risks to infant development
Filter operating specifications
• Maximum TMP* (mmHg/kPa): 450/60
• Maximum blood pressure (mmHg/kPa): 500/66.6
• Minimum blood flow rate:
PRISMAFLEX M100 Set: 75 ml/min
Filter data
• Nominal physical characteristics
– Effective surface area:
PRISMAFLEX M100 Set: 0.9 m²
– Fiber internal diameter (wet): 240 µm
– Fiber wall thickness: 50 µm

Sieving coefficient
• (bovine plasma, Pc 60 g/l, T = 37°C)
Urea = 1, Creatinine = 1, Vitamin B12 = 1,
Inulin = 0.95, Myoglobin = 0.55, Albumin <0.01

In vitro performances
• Blood priming volume in filter ±10%:
PRISMAFLEX M100 Set: 66 ml
• Blood pressure drop (in post dilution mode)
(bovine blood, Hematocrit 32%, Pc*** = 60 g/l, T = 37°C)