PRISMAFLEX M60/M100/M150

The system and sets are intended for patients who have acute renal failure, fluid overload, or both. The combination of these medical devices can be used for veno-venous therapies, such as slow continuous ultrafiltration, continuous veno-venous hemofiltration, continuous veno-venous hemodialysis, and continuous veno-venous hemodiafiltration.

Each of the levels of the sets vary by membrane effective surface area and minimum blood flow rate. The ultrafiltration rate is also different, depending on whether the M60, M100, or M150 set is being used.

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.

PRISMAFLEX M60/M100/M150 are hemofilter sets that are intended to be used for continuous fluid management and renal replacement therapies. They are developed, manufactured, and sold by Baxter International. The sets can be purchased individually or in packs of four by healthcare-related organizations. They are only to be used with PrismaFlex Systems and must be prescribed by a healthcare professional or physician.

The PRISMAFLEXsystem M100 & M150 Setsand shouldsets beare restrictedintended tofor patients with awho bodyhave weightacute greaterrenal thanfailure, 30fluid kgoverload, (66or lb)both. The pediatric usecombination of thethese PRISMAFLEX M60medical Setdevices shouldcan be restrictedused tofor childrenveno-venous withtherapies asuch bodyas weightslow greatercontinuous thanultrafiltration, 11continuous kgveno-venous (24hemofiltration, lb)continuous withveno-venous respecthemodialysis, toand extracorporealcontinuous bloodveno-venous volumehemodiafiltration.

The M150, M100 and 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).

There are some restrictions for the use of the PRISMAFLEX M60/M100/M150 sets. The M100 and M150 sets are intended to be used for patients who weigh over 66 pounds. M60 can be used with children, but only those that are more than 24 pounds.

Each of the levels of the sets vary by membrane effective surface area and minimum blood flow rate. The ultrafiltration rate is also different depending on whether the M60, M100, or M150 set is being used.

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 PRISMAFLEX M100 & M150 Sets should be restricted to patients with a body weight greater than 30 kg (66 lb). 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 M150, M100 and 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).