What is System One?
NxStage's System One is the first and only portable hemodialysis machine cleared specifically by the U.S. Food & Drug Administration (FDA) for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.
When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify the process by using ordinary tap water to create dialysis fluid. Unlike conventional hemodialysis systems, System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use System One, with their trained partners, where, how and when it best meets their needs, including while they're sleeping - at home or on vacation and at a medically appropriate treatment frequency. System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world.
How does NxStage’s System One work?
System One is designed to deliver hemodialysis therapy in a home setting. It consists of the following elements:
- A small control unit containing a fluid pump and user interface (referred to as the cycler).
- A disposable dialyzer and tubing set (referred to as the cartridge).
- Ultrapure fluid (dialysate), prepared by the PureFlow SL dialysate preparation system or in premixed bags for travel.
For each treatment, a new cartridge is inserted into the cycler, where it is prepared for use or primed prior to treatment. The dialysate is generally prepared in advance, in batches, by the PureFlow SL, and is then connected to the cartridge.
During treatment, the cartridge tubing is attached to the patient's blood access. Blood and dialysate pass through the filter to clean the blood. Used dialysate, wastes known as effluent and excess fluids removed from the blood are routed through a waste line on the cartridge and into a drain.
Therapy is complete when the prescribed dialysate volume has been delivered. Daily supplies are thrown away, and the cycler is simply wiped down after use.
What is the difference between NxStage’s System One and System One S?
NxStage's System One S is the latest version of the System One. The designs of the System One and System One S are similar; however, the System One S is capable of higher dialysate flow rates.
How much space does NxStage’s System One take up?
The NxStage System One cycler is just over a foot tall, measuring approximately 15 inches high by 15 inches wide by 18 inches deep. It easily fits into any room at home without any home modifications, and can also be packed into a car or checked (with the appropriate preliminary steps and protective case) for airplane travel. The system plugs into a standard 110V electrical outlet.
The PureFlow SL dialysate purification system is about the size of an end table, and the System One cycler sits on top of it. The PureFlow SL is not portable for travel.
Storage space is required for the disposable supplies, such as cartridges, sacks of concentrated dialysate, and bags of premixed dialysate (for back up and travel), as well as access-related supplies and saline bags.
What responsibilities should patients and their care partners expect?
Home hemodialysis with NxStage requires a patient and partner who are both committed to being trained on and to follow the guidelines for proper system operation. If patients choose to do more frequent home hemodialysis, they will be responsible for complying with their dialysis prescription, which may require treatments up to six days per week. Each treatment can take about 2½ to 3 hours or more including set-up and tear-down.
If patients choose to do home hemodialysis, they and their care partners will need to take on the responsibility for tasks that would normally be taken care of by center staff when receiving treatment in-center. They will need to perform all aspects of the dialysis treatment from start to finish, including setting up the dialysis equipment, needle sticks, responding to and resolving all system alarms, and system disassembly at the end of treatment.
In addition, they must monitor their blood pressure, ensure that proper aseptic technique is followed, and follow all of the training material and instructions given to them by their training nurses. Patients and their care partners will also be trained on and need to know how to respond to any health emergencies that might happen during treatment at home, including dizziness, nausea, hypotension (low blood pressure), and fluid or blood leaks.
To do home hemodialysis successfully, patients must take care to ensure that they have a clean and safe environment for their treatments. They will also need to set aside space in their home for the needed supplies.
What risks are associated with more frequent home hemodialysis?
Studies suggest that patients performing more frequent home hemodialysis may experience slightly fewer complications associated with their treatments, and actually may enjoy improved clinical outcomes.1 However, there are certain risks unique to treatment in the home environment. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed. When vascular access is exposed to daily use, infection of the site, and other access-related complications may also be potential risks.
With more frequent home hemodialysis, patients and their care partners would be taking on a great deal of responsibility, but many NxStage patients feel that the benefits of this therapy are worth taking on these responsibilities. Thousands of patients are performing more frequent home hemodialysis with the NxStage System One and are enjoying the health benefits, improved quality of life, and additional freedom it can provide.
When performed correctly under the direction and with the support of a medical care team, more frequent home hemodialysis with NxStage may offer tremendous health and quality of life benefits. Patients and their care partners must talk to their doctor to better understand the risks involved, how they might apply to them and determine if more frequent home hemodialysis is right for them.
- The FHN Trial Group. In-center hemodialysis six times per week versus three time per week. N Engl J Med. 2010;363:2287-2300.
How is NxStage therapy prescribed?
Patients are prescribed the dialysis therapy that is best for them. Based on their needs, their doctor will decide how frequently they will need to perform their therapy, how much and what kind of dialysate they will use, how long the treatment will last, and what their weight at the end of each treatment should be.
Treatment times will vary based upon your patient's body size and their prescription. A typical more frequent treatment uses 20 to 30 liters of dialysate and takes 2½ to 3 hours to complete.
How are patients trained?
One of the requirements for doing home dialysis with NxStage is that patients have a care partner who is willing to share in the training and responsibility for their home care. Their dialysis center will train patients and their care partners on home-care dialysis therapy. During the training, patients and their care partners will learn how to access their blood, operate the NxStage system, monitor their vital signs, administer their drugs, and handle emergency situations.
The training nurse will adapt the program to meet their needs. Patients may be encouraged to do as much of the therapy as they can, and their center may not require their care partner to attend every day of their training program.
Patients generally complete training in three to four weeks. However, patients will not start treatments at home until they, their care partner, and the center staff feel comfortable that they can safely and confidently perform their treatments.
What help is available?
NxStage resources are available 24/7 to support patients with any technical or equipment questions that might arise. When doing home therapy, patients will most likely visit their dialysis center at least once a month. Centers will also give patients a number to call if they ever have questions about their therapy or their system.
If problems with a patient's system cannot be resolved by phone, NxStage has a "service-swap" program. This means that a replacement machine will be sent to the patient within one business day, and the machine with problems will be exchanged. This service is provided at no cost to the patient.