Fluid processing has traditionally been a major obstacle in making home hemodialysis more accessible to patients. Conventional dialysis machines require large, complex water purification and concentrate mixing systems that limited the viability of fluid preparation in the home environment. NxStage solved this problem and offers patients two convenient fluid options to choose from:
- Concentrate-based option that uses the PureFlow™ SL Dialysate Preparation System to make 40, 50 or 60 liter batches of high quality, lactate-buffered dialysate using ordinary tap water1 and sterile filtered concentrate.
- Prepackaged option of PureFlow™ Dialysate Fluids that consist of sterile, lactate-buffered dialysis fluids packaged in 5 liter bags.
PureFlow SL Dialysate Preparation System
The PureFlow SL Dialysate Preparation System is a compact integrated, self-contained system designed to produce ultra-pure product water from ordinary tap water, which is then precisely mixed with sterile-filtered concentrate to produce high quality dialysate for use in treatment. The advantages of the PureFlow SL System include:
- Minimizing the delivery, storage, management and disposal challenges associated with prepackaged bags of dialysis fluid. Each bag of concentrate used in the PureFlow SL replaces between eight and twelve 5 liter bags of prepackaged dialysis fluids, depending on the patient’s prescription. Eliminating the need to install large, complex water purification and concentrate mixing systems such as those used in a typical dialysis center.
The PureFlow SL System prepares batches of dialysate in the following formulations and volumes:
| Constituents (mEq/L) | SAK-301 | SAK-302 | SAK-303 | SAK-304 | SAK-305 |
|---|---|---|---|---|---|
| Lactate | 45 | 40 | 45 | 45 | 45 |
| Potassium | 1 | 1 | 1 | 2 | 1 |
| Sodium | 140 | 140 | 140 | 140 | 140 |
| Calcium | 3 | 3 | 3 | 3 | 3 |
| Magnesium | 1 | 1 | 1 | 1 | 1 |
| Chloride | 100 | 105 | 100 | 101 | 100 |
| Glucose (mg/dL) | 100 | 100 | 100 | 100 | 100 |
| Batch Size (liters) | 60 | 60 | 50 | 60 | 40 |
PureFlow Dialysate Fluids
Prepackaged NxStage PureFlow Dialysis fluids offer a number of advantages to the patient including:
- Meeting or exceeding AAMI, USP and European Pharmacopeia standards. The products are terminally sterilized and pyrogen-free (<0.25 EU/mL).
- Easily transportable with the System One, thereby offering patients the freedom to travel, with physician prescription, without interrupting their treatment schedule.
- Simple dosing and usage by the patient. The physician determines the number of bags that the patient requires and the patient simply hangs and connects the proper number of bags per treatment.
NxStage PureFlow Dialysate Fluids are available in the following formulations for home hemodialysis:
| Constituents (mEq/L) | RFP-204 | RFP-207 | RFP-209 |
|---|---|---|---|
| Lactate | 40 | 45 | 45 |
| Bicarbonate | 0 | 0 | 0 |
| Potassium | 1 | 1 | 2 |
| Sodium | 140 | 140 | 140 |
| Calcium | 3 | 3 | 3 |
| Magnesium | 1 | 1 | 1 |
| Chloride | 105 | 100 | 101 |
| Glucose (mg/dL) | 100 | 100 | 100 |
| Osmolarity (mOsmol/L) | 294 | 294 | 297 |
NxStage PureFlow solution is indicated for use with renal replacement systems that utilize sterile premixed dialysate. They are not intended for direct infusion.
- 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.
