nxstage system one user manual
NxStage System One offers a revolutionary approach to renal care, empowering patients with greater independence and flexibility in managing their end-stage renal disease (ESRD).
The System One, backed by FDA approvals and the Freedom Study, demonstrates improved quality of life and clinical benefits for home hemodialysis patients.
Speedswap technology and ongoing advancements, driven by patient feedback, continually enhance the therapy experience and accessibility of this life-changing system.
What is the NxStage System One?

The NxStage System One represents a significant advancement in home hemodialysis technology, designed to provide patients with greater control and freedom over their treatment schedules. Unlike traditional in-center dialysis, this system enables therapy to be performed conveniently in the comfort of one’s own home.
Approved by the FDA for solo home hemodialysis, it eliminates the need for a dedicated care partner during treatment sessions. This innovative platform, developed with extensive patient feedback, utilizes a compact and portable machine coupled with specialized dialyzers and solutions. The System One is a complete, self-contained system, offering a life-changing therapy option for individuals with end-stage renal disease (ESRD), as highlighted by the positive results from the Freedom Study;
Benefits of Home Hemodialysis with NxStage System One
Home hemodialysis with the NxStage System One delivers substantial clinical and quality of life improvements for patients with end-stage renal disease (ESRD). The Freedom Study demonstrates a marked increase in overall well-being and a more flexible treatment schedule, empowering patients to reclaim their independence.
Beyond convenience, this system offers potential benefits such as improved blood pressure control and reduced hospitalizations. The Speedswap technology further streamlines the process, making it more efficient and user-friendly. Ultimately, the System One provides a pathway towards a more fulfilling and active lifestyle, supported by FDA-approved technology and dedicated medical support.

System Components and Setup
NxStage System One comprises the machine, dialyzers, and solutions, requiring careful setup for effective treatment. Proper configuration ensures optimal performance and safety.
NxStage System One Machine
The NxStage System One is a portable hemodialysis machine designed for home use, offering patients increased treatment flexibility. It features a user-friendly interface with integrated system checks to ensure safe and effective operation. The machine’s compact size allows for placement in various home environments, promoting patient independence.
Key features include automated self-testing, simplified setup procedures, and real-time monitoring capabilities. The system is engineered for reliability and ease of use, minimizing the burden on patients and caregivers. Regular software updates, facilitated by connectivity features, enhance performance and introduce new functionalities, continually improving the overall dialysis experience.
Consumables: Dialyzers and Solutions
NxStage System One requires specific consumables for each treatment, primarily dialyzers and dialysis solutions. Dialyzers, responsible for filtering waste products from the blood, are single-use and must be replaced after each session. Dedicated solutions are crucial for creating the dialysate, the fluid that draws impurities across the dialyzer membrane.
Proper storage and handling of these consumables are vital to maintain sterility and ensure treatment efficacy. The system is designed to work optimally with NxStage-approved dialyzers and solutions, guaranteeing compatibility and performance. Careful adherence to the user manual’s guidelines regarding preparation and disposal is essential.
Setting Up the System for Treatment
Preparing the NxStage System One involves several key steps detailed in the user manual. First, ensure a stable power source and adequate space. Next, connect the dialyzer and solution containers, verifying secure connections to prevent leaks. Prime the system with solution, following the guided prompts on the machine’s interface.
Proper priming eliminates air bubbles, crucial for patient safety. The manual emphasizes meticulous attention to detail during setup, as correct assembly directly impacts treatment effectiveness. Always confirm all connections before initiating the cycle, and refer to the troubleshooting section for any setup-related issues.

Operating the NxStage System One
System One operation, guided by the user manual, begins with system checks and power-on sequences. Treatment initiation follows precise prompts, ensuring accurate delivery and monitoring.
Continuous monitoring during cycles is vital, with alarms providing immediate alerts for any deviations from prescribed parameters, enhancing patient safety.
Powering On and System Checks
Initiating the NxStage System One requires a systematic approach, beginning with connecting the machine to a grounded power outlet. Upon powering on, the system performs a series of automated self-checks, crucial for ensuring operational safety and efficacy. These checks verify the functionality of key components, including the pump, sensors, and alarm systems.
The user interface will display the progress of these checks, and any detected errors will be clearly indicated with corresponding alarm notifications. It’s essential to address any error messages before proceeding with treatment, consulting the user manual for troubleshooting guidance. Successful completion of the system checks is confirmed by a ready indicator, signaling the machine is prepared for treatment initiation.
Initiating a Treatment Cycle
Starting a treatment on the NxStage System One involves precise steps. First, confirm successful system checks and proper connection of the dialyzer and solution bags. The machine prompts for treatment settings – duration, blood flow rate – customizable based on physician orders. Input these carefully via the user interface.
Next, initiate the priming phase, which removes air from the system. Once primed, the machine will automatically begin drawing blood, initiating hemodialysis. Continuous monitoring is vital during this phase. The system provides clear visual and auditory cues throughout the cycle, ensuring a controlled and safe treatment process.
Monitoring During Treatment
Consistent monitoring is crucial during each NxStage System One treatment. Regularly observe the machine’s display for vital signs like blood pressure, treatment time remaining, and any alarm notifications. Pay close attention to blood flow rates and dialysate levels, ensuring they remain within prescribed parameters.
Visually inspect the dialyzer for any clotting or abnormalities. The system’s alarms are designed to alert you to potential issues; promptly address any alarms following the troubleshooting guide. Maintaining vigilant oversight guarantees a safe and effective hemodialysis session.

Safety Features and Alarms
NxStage System One incorporates multiple safety features and alarm systems to protect patients during treatment, alerting users to potential issues promptly.
Understanding alarm notifications and following troubleshooting steps ensures safe operation and minimizes risks associated with home hemodialysis therapy.
Alarm Notifications and Troubleshooting
The NxStage System One utilizes a comprehensive alarm system to alert users to various conditions during treatment. These alarms can indicate issues with blood flow, pressure, air detection, or system malfunctions. The user manual details each alarm, providing clear explanations and corresponding troubleshooting steps.
Common troubleshooting includes checking connections, verifying solution levels, and ensuring proper access site function. Ignoring alarms can compromise treatment effectiveness and patient safety; therefore, prompt attention and adherence to the manual’s guidance are crucial. Familiarizing yourself with the alarm protocols before initiating therapy is highly recommended for a safe and effective experience.
Safety Protocols During Operation
The NxStage System One demands strict adherence to safety protocols for effective and secure home hemodialysis. The user manual emphasizes maintaining a clean treatment environment, proper hand hygiene, and diligent monitoring throughout the cycle. Never operate the system with damaged components or altered settings.
Patients must understand access site care, recognizing signs of infection or complications. Electrical safety is paramount; ensure proper grounding and avoid water exposure near the machine. In case of an alarm or unexpected event, immediately pause treatment and consult the manual or medical support for guidance. Prioritizing these protocols safeguards patient well-being.

Maintenance and Cleaning
Regular cleaning and adherence to the NxStage System One maintenance schedule are crucial for optimal performance and longevity of the device, ensuring safe therapy.
Daily procedures and scheduled upkeep, detailed in the user manual, prevent malfunctions and maintain the system’s effectiveness for consistent treatment.
Daily Cleaning Procedures
Following each treatment, thorough cleaning of the NxStage System One is essential to prevent infection and maintain optimal functionality. Begin by disconnecting all fluid lines and disposing of used materials according to established protocols.
Wipe down the exterior surfaces of the machine with a mild disinfectant solution, paying close attention to areas that may have come into contact with bodily fluids. The dialyzer holder should be rinsed thoroughly with clean water to remove any residual dialysate.
Inspect all tubing and connections for any signs of damage or leakage. Refer to the user manual for specific instructions on cleaning and disinfecting reusable components, ensuring adherence to recommended guidelines for effective pathogen control and prolonged system life.
Regular Maintenance Schedule
Adhering to a consistent maintenance schedule is crucial for the longevity and reliable performance of your NxStage System One. Monthly inspections should include checking all tubing connections for wear and tear, and verifying the functionality of the system’s alarms.
Every six months, consider a professional service check to ensure optimal operation and address any potential issues proactively. The user manual details specific filter replacement intervals and cleaning procedures for internal components.
Annual preventative maintenance, performed by a qualified technician, guarantees continued safe and effective therapy, maximizing the lifespan of your investment and upholding the highest standards of renal care.

Troubleshooting Common Issues
Addressing error messages and connectivity problems is vital for uninterrupted therapy. The user manual provides detailed guidance and solutions for typical NxStage System One challenges.
Addressing Error Messages
The NxStage System One user manual is your primary resource for deciphering and resolving error messages. Each code indicates a specific issue, ranging from minor alerts to situations requiring immediate attention.
Common errors relate to blood leak detection, pressure discrepancies, or connectivity failures. The manual provides step-by-step troubleshooting guides, often starting with simple checks like hose connections and solution levels.
If an error persists, the manual directs users to contact NxStage Medical Support, providing the specific error code for efficient assistance. Ignoring error messages can compromise treatment effectiveness and safety, so prompt action is crucial.
Resolving Connectivity Problems
The NxStage System One user manual details troubleshooting steps for connectivity issues, vital for data transmission and remote monitoring. Problems often stem from network disruptions or incorrect modem configurations.
The manual guides users through verifying internet access, checking cable connections, and restarting the system. It also explains how to confirm the modem is properly paired with the machine.
If issues persist, NxStage Medical Support can provide remote diagnostic assistance. Maintaining a stable connection ensures accurate treatment data and access to crucial updates and support resources.

Recent Advancements and Updates
NxStage System One continually evolves with FDA approvals, Speedswap technology, and insights from the Freedom Study, enhancing patient care and quality of life.
FDA Approvals and Regulatory Information
NxStage Medical, Inc. has consistently prioritized securing FDA clearance for the System One platform, ensuring its safety and efficacy for home hemodialysis. Notably, the FDA approved the System One for solo home hemodialysis treatment, a significant advancement allowing patients to undergo therapy without requiring a dedicated care partner.
This regulatory approval underscores the system’s user-friendly design and robust safety features. Ongoing compliance with FDA regulations is maintained through rigorous quality control measures and continuous monitoring of post-market surveillance data. The company actively communicates updates and any relevant regulatory information to healthcare professionals and patients, ensuring transparency and adherence to the highest standards of care.
Speedswap Technology and its Benefits
Speedswap represents a significant innovation for NxStage System One users, offering a streamlined and efficient dialyzer exchange process. This new option, recently made available by Fresenius Medical Care North America, dramatically reduces the time required to prepare for each treatment session.
By simplifying the dialyzer connection, Speedswap minimizes setup complexities and potential errors, enhancing the overall user experience. This technology contributes to greater independence for patients performing home hemodialysis, allowing for a more convenient and less disruptive therapy schedule. Ultimately, Speedswap promotes improved adherence and quality of life.
Freedom Study Results and Quality of Life Improvements
The ongoing Freedom Study, conducted by NxStage Medical, Inc., has consistently demonstrated substantial improvements in the overall quality of life for patients utilizing the System One for home hemodialysis. Interim results reveal a notable increase in patient-reported outcomes, encompassing physical, emotional, and social well-being.
These findings underscore the benefits of greater treatment flexibility and independence afforded by the NxStage System One. Patients experience enhanced control over their schedules and reduced reliance on traditional in-center dialysis, leading to a more fulfilling and active lifestyle. The study validates the system’s positive impact.

Resources and Support
NxStage Medical Support provides comprehensive assistance, including direct contact options and extensive online resources.
Detailed training materials are readily available to ensure users confidently operate and maintain the System One effectively.
NxStage Medical Support Contact Information
For immediate assistance with your NxStage System One, dedicated support teams are available to address your needs promptly and efficiently. Patients can reach NxStage Medical Support through various channels, ensuring convenient access to expert guidance.
Phone support offers direct communication with trained professionals who can troubleshoot issues, answer questions, and provide personalized assistance. Additionally, a wealth of online resources, including FAQs, troubleshooting guides, and educational videos, are accessible 24/7. These resources empower users to resolve common issues independently and enhance their understanding of the system. Contact information is readily available on the official NxStage website and within the System One user manual itself, guaranteeing easy access to vital support whenever needed.
Online Resources and Training Materials
NxStage provides a comprehensive suite of online resources designed to empower users with the knowledge and skills needed for successful home hemodialysis. The official website hosts an extensive library of training materials, including detailed user manuals, instructional videos, and frequently asked questions.
These resources cover all aspects of the System One, from setup and operation to maintenance and troubleshooting. Interactive tutorials and virtual training sessions offer hands-on learning experiences, while downloadable guides provide convenient offline access to essential information. Dedicated online portals also facilitate communication with NxStage support teams and access to personalized training programs, ensuring a seamless and supportive learning journey.
