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The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center. The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging. The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis treatment data from the patient and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education, has the ability to add picture attachments through the notes in a flowsheet, and the ability for the Clinician to remotely access snapshots of patient's treatment data while the treatment is taking place. The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.

The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center. The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging. The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis data from the patients on the completion of their dialysis treatment and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging. The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.

The NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

The NxStage Dosing Calculator is a software modeling program designed to assist physicians and licensed healthcare practitioners in prescribing chronic hemodialysis therapy with the NxStage System One and NxStage Cartridge with pre-attached dialyzer. It allows physicians and licensed healthcare practitioners to determine a range of appropriate treatment frequencies, treatment durations, and therapy fluid volumes. The program incorporates formulas that have been published in peer reviewed journals of medicine and models treatment parameters for a range of possible treatment frequencies, volumes, and durations. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient.

OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access. OneView is contraindicated as the sole method of monitoring a patient during treatment.

OneView is an optional computer-based interface accessory to the NxStage System One to provide on-line instructions for use, summarized system information, and remote viewing of treatment information. OneView consists of software, a flat panel touch screen display, and a central processing unit (CPU).

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel. This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system. It is an updated version of the Fresenius FDS08.

The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate total urea clearance (Kt/V), total urea clearance (Kt/V) delivered using the natural log formula, residual renal urea clearance (KrU), normalized protein catabolic rate (NPCR), actual blood flow, urea reduction ratio, body water volume calculated by urea kinetic modeling, total body water volume calculated using Watson's formula, actual weight loss after treatment, percent deviation (%Dev), and treatment time. These values are calculated using the test results of blood drawn immediately prior to and upon completion of kidney hemodialysis treatment based on the existing scientific formulas for single pool urea kinetic modeling. The device software is not meant to serve as the sole tool for determining effectiveness of treatment but as an adjunct to assist the physician in making the determination.

The CSAM CKHEMO rev 1.0 software computer program is a stand-alone product used to calculate various parameters related to kidney hemodialysis treatment based on test results of blood drawn before and after treatment and existing scientific formulas for single pool urea kinetic modeling.

High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renaline concentration is 3% as it is intended to be. After the kidney is placed under storage until next use, the Renaling concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalins concentration has been maintained at 1% or higher. If the Renaling concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.

High Range Peroxide™ Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. It is a self-contained, ready to use dip-andread reagent strip without additional reagent. The strip is packaged in 50 or 100's in bottles. Color blocks corresponding to Renalin8 concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalink concentration can be made by comparing the strip color to the color blocks.

WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.

WaterCleck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.