System one s therapy options for every lifestyle the system one s combines the reliability of the system one and the added treatment flexibility of highflow capabilities. Nxstage system one fact sheet about nxstage system one the nxstage system one is the only truly portable hemodialysis system cleared for home use during the day or overnight. The nxstage system one is not specifically indicated for nocturnal use. This document is not intended to replace the nxstage system one or pureflow sl users guide or cartridge instructions for use.
The nxstage system one is the first and only truly portable hemodialysis system cleared for home use in the united states, including solo hemodialysis during waking hours, and nocturnal hemodialysis, while both the patient and care partner sleep. Nxstage system one cycler used to warm dialysate prior to administration. We presented the complete version of this book in doc, djvu, epub, txt, pdf formats. The device is operated using controls on the cycler user interface. I finally got my hands on some manuals, and this is what i read. Nxstage user manual pdf sourish33 view online or free download from customer is responsible for transporting systems according to the shipping directions provided by nxstage in the device operator s manuals nxstage user s the nxstage system one is a prescription device and, like all medical devices, involves some. Prescription use x andor overthecounter use part 21 cfr 801 subpart d 21 cfr 807 subpart c please do not write below this linecontinue on another page if needed. The dialysis fluid for use with the nxstage system one can come from 2 sources.
A piece of copal may be used as the heart in poppets. The nxstage system one has been compared to the legally marketed predicate device as cleared through k141752 december 19, 2014 and was found to be substantially equivalent. Use the system one cycler 83 to 89 treatment process 60 day 5 subtopic tab name nurse guide pages tm0679 only teach section time minutes patient competency care partner competency use the system one cycler 83 to 89 treatment process reinforcement 60 access your blood 38 to 40 vascular access care and complications 30 nxsteps online. The indications for use of the proposed device and of the predicate device are identical. No later than 10 days after the acquisition date, respondents shall divest the. Nxstage continuous renal replacement therapy crrt orders. To understand how nxstage treats and uses your information, please refer to our privacy policy. You may reading nxstage system one manual critical care online or download. Nov 07, 2017 nxstage has prepared this document as suggested steps for centers in using the nxstage system one for transitional care dialysis. Nov 09, 2017 nxstage has prepared this document as suggested steps for centers in using the nxstage system one for transitional care dialysis.
Federal us law restricts these devices to sale by or on the order of a physician. Not only does fresenius renal technologies offer one of the worlds leading dialysis water treatment systems, our team offers professional installation to match. You can reading nxstage user manual online or load. This document is not intended to replace the nxstage system one or pureflow sl user guides or cartridge instructions for use and does not include all of the information necessary to use the system safely and effectively. Nov 10, 2017 nxstage has prepared this document as suggested steps for centers in using the nxstage system one for transitional care dialysis. The individual components of the nxstage system one are listed below.
This podcast provides a high level overview of the nxstage system one. The nxstage system one was developed to address these challenges. Nxstage crrt user manual free download nxstage crrt user manual pdf. Many nxstage patients enjoy the health benefits of daily hemodialysis while on vacations, motor home excursions, and ocean cruises. To view pdf files, you need to download adobe acrobat reader. Please note that this video is not intended to replace the nxstage system one users guide or cartridge instructions for use. Beyond its use in the home, the nxstage system one is designed to be portable. All forms of hemodialysis, including treatments performed incenter and at home, involve some risks. Learn how to use the nxstage system one cycler with bagged dialysate and the express fluid warmer in part 2 of our 3 part videos series. Nxstage system one setup and use nxstage medical uk ltd.
Learn how to set up the the nxstage system one and take the first step towards home hemodialysis. Introducing the nxstage system one esrd network 18. If looking for a ebook nxstage user manual in pdf form, then youve come to right website. The dialysis fluid for use with the nxstage system one can.
Car 124c cartridge 124c allows the user to attach a desired dialyzer to the cartridge. S patent and trademark office and is owned by nxstage medical, inc. Nxstage system one user guide for more details on system settings. Set are accessories the nxstage system to the nxstage one used to warm system one cycler dialysate prior to used to warm administration dialysate prior to administration.
The nxstage pureflow sl module is an optional accessory to the nxstage system one that prepares dialysate for use during hemodialysis, as prescribed bythe physician. The current ce mark is held by nxstage medical inc. Setup for feb 12, 2012 this video provides an overview of how to use the nxstage system one cycler with. For additional details on the system components, see the nxstage system one product brochure, apm494 or outside of the us. The nxstage system one s with nxview is a simple and versatile system to treat icu patients requiring renal replacement therapies. The nxstage system one is designed to deliver haemodialysis therapy in a home setting. Let us make your job easier with one of the leading dialysis water treatment system on the global market. Heating same one aluminum plate method heated by electrical resistance fluid 3 c30 temperatures same adjustable temperature same thermistors control alafrmlogic. The nxstage system one is a transportable haemodialysis device intended for use in the home or while travelling by adults and children suffering from stage 5 ckd. Many nxstage patients enjoy the health benefits of more frequent hemodialysis while on vacations, motor home excursions, and ocean. The nxstage system one first received a ce mark in april 2004. Introducing the nxstage system one 10 steps closer to home hemodialysis, with the nxstage system one. It was very frustrating because we couldnt get the manual rinse back to work and i forfeited my blood.
Federal law restricts this device to sale by or on the order of a physician. The nxstage system one is comprised of the nxstage cycler, an electromechanical control unit and the nxstage cartridge, a sterile, singleuse extracorporeal blood and fluid management circuit with or without a preattached high permeability filter that mounts integrally within the nxstage cycler. It is not intended to be used as a training tool or to replace the nxstage system one users guide or the cartridge instructions for use. Eto or ebeam sterilization methods are not used in any nxstage products. We furnish the full version of this book in epub, txt, doc, djvu, pdf forms. When this happened a second time at the end of treatment, i called nxstage and they gave us this advice. System specifications flow rates nxstage system one s nx3 blood up to 600 mlmin dialysate up to 18 lhour ultrafiltration up to 2.
The system is an innovative, flexible device that delivers hemodialysis, hemofiltration, andor ultrafiltration therapies to. Download nxstage user manual pdf nxstage user manual pdf host. System one machines means machines and disposables including cartridges used in respondent nxstage s system one portable hemodialysis system. The nxstage system one plus is comprised of the nxstage cycler, an electromechanical control unit. Patent and trademark office and is owned by nxstage medical, inc. It was specifically designed for patients to use in their homes, and is small enough to allow. In addition, there are certain risks unique to treatment in the home environment.
Nxstage system one set up and use nxstage medical inc. Please refer to the nxstage user guide for more information. Post that log and a new hijackthis log in another reply. The nxstage trademark is also registered in the european union, canada, australia, new zealand and japan. Nxstage continuous renal replacement therapy crrt orders page 1 of 1 allergy. For that reason, the nxstage system one is designed to provide simplicity and versatility that allows the delivery of renal replacement therapy throughout the continuum of patient care. Nov 19, 2014 the nxstage system one is a transportable haemodialysis device intended for use in the home or while travelling by adults and children suffering from stage 5 ckd.
Nxstage dialyzer 510k premarket notification submission device cornparison table predicate device predicate device nxstage 1. Leadership in crrt nxstage provides a full range of critical care products that enable you to implement your program, including the system one nxstage user manual free ebooks download nxstage user manual download on free books and manuals search service manual. As well, on our website you may read instructions and different art books online, or load their. Introduction hypothesis results conclusions the results demonstrated that the nxstage pureflow sl system, compared to the manual myron l d meter, measures conductivity accurately. It incorporates the perspectives of some of the clinical investigators and advisors to nxstage, and assumes knowledge of the system s components. Higher dialysate flow rates may mean the ability to increase clearance, put larger patients on therapy, or decrease treatment time or frequency. Learn how to set up and use the nxstage system one cycler with bagged dialysate and the express fluid warmer in this 3 part video series. Nxstage home hemodialysis use in remote or rural settings.
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