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Stay Safe continuous ambulatory peritoneal dialysis

stay·safe® CAPD System

Continuous ambulatory peritoneal dialysis (CAPD) is a simple, safe, and effective peritoneal dialysis (PD) technique, especially for patients who have been identified as low or low-average transporters.1

Learn More Ģý stayĢýsafe CAPD

To learn more about stayĢýsafe, please fill out the form below.

Consider CAPD for Incident and Incremental End Stage Renal Disease (ESRD) Patients

    • 85 percent of incident end stage renal disease (ESRD) patients start dialysis with a GFR >5mL/min/1.73m22
    • The CAPD modality can provide a gentler onboarding process

    Potential Benefits of CAPD for ESRD Patients

        • Better preservation of residual kidney function3
        • Greater ultrafiltration and sodium removal for appropriate patients4
        • Increased phosphorus clearance5
        • Improved sleep quality6

        stayĢýsafe - An Innovative Design to Support CAPD Patients

        stayĢýsafeĢýs simple and smart product design supports patients during a CAPD exchange and is designed to reduce patient dropouts due to technique failure, infections, burnout, or other common reasons. The goal is to make the therapy more intuitive and help patients in reducing procedural steps to reduce the overall therapy burden in the long run.

        A. Every PD exchange starts with ĢýDrainĢý by default.

        B. The stayĢýsafe DISC with the blue dial guides the patients in only 4 steps: Drain, Flush, Fill, and Close. The stayĢýsafe DISC eliminates the need to clamp and unclamp lines. It may be easier to train patients on stay·safe CAPD.7

        C. The stayĢýsafe PIN automatically closes the catheter extension set before disconnection.

        Three Unique stayĢýsafe CAPD Features

        The stayĢýsafe CAPD systemĢýs is designed to help patients perform their daily self-care CAPD treatment in a safe and convenient way. The stayĢýsafe CAPD systemĢýs unique featuresincluding the stayĢýsafe DISC, stayĢýsafe PIN, and stayĢýsafe Organizer work together to promote ease of use.

        The stayĢýsafe Organizer

        The stayĢýsafe Organizer is designed to bring all parts of the stayĢýsafe CAPD system together and includes built-in locations for the stayĢýsafe catheter extension set and stayĢýsafe cap. This all-in-one Organizer simplifies the patientĢýs role in the CAPD exchange procedure.

        The stayĢýsafe DISC

        The central part of the stayĢýsafe CAPD system is theDISC with its distinctive blue dial. By simply turning the dial, the patient performs all the essential stepsof the CAPD procedure: drain, flush, fill, and close.

        The stayĢýsafe PIN Technology

        When turning the dial to the fourth step (PIN/Close),a PIN is inserted into the catheter extension set before disconnecting from the system. The number of systems openings is reduced by 50% which may reduce the potential risk of contamination.

        stayĢýsafe CAPD DesignĢý Easy to Learn, Easy to Use

        Intuitive operation and simple patient instructions designed to promote successful treatment

        Step 1: Drain

        To begin, open the clamp on the catheter extension set. The dial is already set to Position 1 (Drain).

        Step 2: Flush

        Once the Drain step is completed, turn the dial to Position 2to Flush the tubing.

        Step 3: Fill

        After the Flush step, turn the dial to Position 3 to Fill theperitoneal cavity with DELFLEX®Dextrose Peritoneal Dialysis Solution. The stayĢýsafe DISC allows control of fluid flow duringthe Fill.

        Step 4: PIN/Close

        When the Fill step is completed, turn the dial to the finalPosition 4 to PIN/Close.

        stayĢýsafe PIN Technology

        Catheter connection technique is known to be a factor contributing to peritonitis rates.8With the stayĢýsafe systemĢýs patented PIN technology, the potential for accidental contamination and subsequent infection may be reduced.

        The stayĢýsafe PIN seals the fluid pathway prior to catheter extension set disconnection during both CAPD and APD. With only one system opening per treatment, the stayĢýsafe CAPD system has half the openings of conventional CAPD systems, which may reduce the potential risk of touch contamination

        .

        25 Years of stayĢýsafe

        Since 1996, stayĢýsafe has provided trusted CAPD technology to peritoneal dialysis patients around the world technology to dialysis patients around the world and has been in the U.S.market since 2004.

        The stayĢýsafe PIN technology is used in APD with the Liberty®Select cycler.Today, over 20,000 PD patients in the U.S. benefit from the advantages of the stayĢýsafe PIN technology to perform CAPD and APD with ease.

        TRUSTED FOR MORE THAN 25 YEARS

        References:

        1. Blake PG & Daugirdas JT, Physiology of Peritoneal Dialysis, Handbook of Dialysis 5th edition, pp. 392 -407.
        2. United States Renal Data System. 2020 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2020.
        3. Nongnuch, A., Assanatham, M., Panorchan, K., Davenport, A., Strategies for preserving residual renal function in peritoneal dialysis patients, Clinical Kidney Journal, Volume 8, Issue 2, April 2015, Pages 202Ģý211, https://doi.org/10.1093/ckj/sfu140.
        4. Maharjan SRS, Davenport A. Comparison of sodium removal in peritoneal dialysis patients treated by continuous ambulatory and automated peritoneal dialysis. J Nephrol. 2019 Dec;32(6):1011-1019.
        5. Courivard & Davenport (2015) Phosphate removal in PD; Peritoneal Dialysis International, Vol. 36, pp.85Ģý93.
        6. Roumeliotis et al (2020), APD or CAPD: one glove does not fit all. Int. Urology and Nephrology, https://doi.org/10.1007/s11255-020-02678-6.
        7. Lambert, MC, Lage, C, Kirchgessner, J., stayĢýsafe®. A new PVC free system. EDTNA|ERCA JOURNAL 1999 XXV 3.
        8. Port, F.K., P.J. Held, K.D. Knolph, M.N. Turenne, R.A. Wolfe. ĢýRisk of Peritonitis and Technique Failure by CAPD Connection Technique: A National Study.Ģý Kidney International 42 (1992): 967-974.

        Indications for Use:DELFLEX is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.

        DELFLEX is available by prescription only.

        IMPORTANT SAFETY INFORMATION

        • Intended for intraperitoneal administration only
        • Not for intravenous or intra-arterial administration
        • Use aseptic technique throughout the procedure
        • Monitor routinely for electrolyte, fluid, and nutrition imbalances
        • Monitor for signs of peritonitis or overfill
        • Inspect the drained fluid for fibrin or cloudiness
        • Ensure that there is no leakage around the catheter
        • Solution-related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort

        To report SUSPECTED ADVERSE REACTIONS, contact Ģý North America at 800-323-5188. You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Visit MedWatch or call 1-800-FDA-1088.

        Fresenius CAPD stayĢýsafe®Disposable Administration Sets with stayĢýsafe®Connector:

        The Fresenius CAPD stayĢýsafe®Disposable Administration Sets with stayĢýsafe®Connector is indicated for use in end-stage acute and chronic renal disease.
        Liberty®Select

        stayĢýsafe Catheter extension set:

        The stayĢýsafe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stayĢýsafe catheter extension set with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stayĢýsafe PIN technology.

        stayĢýsafe Cap:

        The Fresenius sterile stayĢýsafe®Cap is intended to be used for closure of the stay safe stayĢýsafe peritoneal dialysis connectology system.

        Liberty Select Cycler:

        Indications for Use:The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

        Caution:Federal (US) law restricts this device to sale by or on the order of a physician.

        Note:Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at www.fmcna.com.

        ©2009, 2018-2023 Ģý. All Rights Reserved. Ģý, the triangle logo, Liberty, stay·safe, and DELFLEX are trademarks of Ģý Holdings Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 100969-01 Rev F 06/2023