Fluid processing has traditionally been a major obstacle in making home hemodialysis more accessible. Conventional dialysis machines require large, complex water purification and concentrate mixing systems that limit the viability of fluid preparation in the home. NxStage has risen to the challenge and offers patients both easy-to-use portable pre-mixed fluids as well as space-saving concentrate options.
PureFlow SL Dialysate Preparation System
The PureFlow SL Dialysate Preparation System is a compact, integrated system designed to produce ultra-pure product water from ordinary tap water1, which is then precisely mixed with sterile-filtered concentrate to produce high quality dialysate.
PureFlow SL minimizes the delivery, storage, management and disposal challenges associated with pre-packaged bags of dialysis fluid. Each bag of concentrate replaces between eight and twelve 5-liter bags of pre-packaged dialysis fluids, depending on the patient’s prescription.
The PureFlow SL System prepares batches of dialysate in the following formulations and volumes:2
|Batch Size (liters)||60||60||50||60||40||50||50|
PureFlow Dialysate Fluids
Pre-packaged PureFlow Dialysis fluids offer a number of benefits advantages:
- Premixed fluid bags are manufactured to European Pharmacopoeia standards and USP. Premixed dialysate bags are terminally sterilized and non-pyrogenic (<0.25 EU/mL).
- Premixed fluid bags also meet ISO 10993 Biological Evaluation of Medical Devices, which consists of a series of tests intended to address potential biological risks arising from the use of a medical device.
- Pre-packaged fluid bags are portable along with the System One. This offers patients the freedom to travel, with physician prescription, without interrupting their treatment schedule.
- Dosing and usage by the patient has been simplified. The physician determines the number of bags the patient requires; the patient simply hangs and connects the bags for treatment.
NxStage PureFlow Dialysate Fluids are available in the following formulations for home hemodialysis:3
|Calcium||3 (1.5mmol/L)||3.5 (1.75mmol/L)|
NxStage PureFlow solution is indicated for use with renal replacement systems that utilize sterile premixed dialysate. They are not intended for direct infusion.
For more information on NxStage home hemodialysis and associated dialysate fluids, download a complimentary Therapy Handbook.
- The PureFlow SL System is designed for use with water that meets the Primary and Secondary Drinking Water Standards of the US Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA). Every public water system in the in the United States must conform to the Primary Standards of the SDWA, and they must provide annual reports confirming this compliance. PureFlow SL System users with a municipal (public) water supply can verify their water supplier’s compliance to the Primary Standards by contacting the supplier. The Secondary Drinking Water Standards which include such contaminants as aluminum, silver, zinc. sulfates and Total Dissolved Solids (TDS) are “recommended” limits set by the EPA for aesthetic purposes, rather than health concerns, and they are not legally enforceable. The SDWA does not apply to private water supplies. Refer to http://water.epa.gov/drink/contaminants/index.cfm for more information on the US EPA Safe Drinking Water Act. Patients must contact their center to arrange for the appropriate testing of their tap water to confirm that it meets the PureFlow SL Source Water Purity Requirements as listed in the PureFlow SL User’s Guide prior to using the PureFlow SL.
- This web page includes references to different versions of the PureFlow SL Dialysate Sacks (SAK-xxx), the dialysate concentrates intended to be used with the NxStage System One. Please note that not all versions and formulations of the dialysate concentrates (SAK) are currently available for purchase in all countries.
- Product Disclaimer: Not all products are cleared or available for sale in all countries.