phoenix x36
Transcription
phoenix x36
PHOENIX X36 Hemodialysis System Making possible personal. PHOENIX X36 The PHOENIX Hemodialysis System The PHOENIX X36 Hemodialysis Delivery System is intended to be used to provide high-flux and low-flux hemodialysis, hemofiltration, and ultrafiltration on patients weighing 15 kg or more. With features such as real-time Kt/V monitoring through the DIASCAN monitoring system, compensated blood flow, full-color touch screen, and sodium and UF profiling, the PHOENIX X36 Hemodialysis System is designed to help provide effective hemodialysis therapy. Multiple automatic features 1 • Machine safety tests at the beginning of each treatment • Safety tests performed every morning • Calibration of the UF system performed during treatment • Testing of the DIACLEAR ultrafilter membrane Clinical tools designed to assist patient monitoring Compensated Blood Flow 1 DIASCAN Monitoring System 1 • Actual blood flow compensated for the negative arterial • Ionic Clearance and Plasma Conductivity measured pressure • An accuracy of +/-10% of blood flow to pump speed* during the treatment • Forecast Kt/V delivers information on status during treatment • Ability to compare previous patient treatments to assess dialysis efficacy • Potential blood circuit issues can be monitored by comparing Ionic Clearance and blood flow • Automatically calibrated every day *In double needle mode, if the pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is higher than -150 mmHg. No Transducer Protectors No Risk for Cross-Contamination BICART Cartridge1 •O nline preparation of sodium bicarbonate solution •B ICART Cartridges come in 2 sizes •B ICART Cartridges can be reused within 24 hours No Documentation No Bicarbonate Mixing HIV HCV CARTRIDGE Blood Set • Non-invasive system No Transducer Protectors No CrossContamination No Priming Bucket • Compact bloodline • Low extracorporeal blood volume: 103 mL No Transducer Protectors • Sterilized by gamma radiation. No Bacterial Growth Waste Handling Option1 No Bicarbonate Mixing No Charting Errors No Risk for Cross-Contamination No Patient Disks No Documentation No Bicarbonate Mixing • Functionally integrated into the CARTRIDGE Blood Set • Priming fluids go directly to the drain • No priming bucket required No Priming Bucket No Priming Bucket IT Connectivity1 • Standard Ethernet network connection • Connects to electronic medical record No Charting Errors • Integrates with patient prescription downloads with the EXALIS Dialysis Management Tool No Patient Disks No Charting Errors No Patient Disks Gambro Technical Service (GTS) is a nationwide service provider for Gambro products. GTS has a strong tradition of providing exceptional service to our customers by helping them comply with local, state, and federal guidelines in respect to maintenance of medical devices. GTS certified field service reps are strategically located throughout the country to quickly respond to your service needs. Every PHOENIX X36 Hemodialysis System comes with a standard 12-month warranty, but to help maximize the product’s life and reduce down time, GTS offers a variety of service options to meet your needs. Premier Partnership Elite Partnership It’s a comprehensive program that keeps your product maintained to current manufacturer’s specifications. Using computerized scheduled maintenance, original manufacturer’s parts, and geographically placed certified technicians with certified test equipment, your machine performance is This is a multi-level contract-based program. The program uses the customer’s Gambro Certified staff to provide first look and minor repairs with the support of Gambro’s technical phone team. Our GTS staff provides additional on-site support for more maintained at a fixed cost. This program provides: • Solutions at a fixed cost • Reduced downtime of machines • No unforeseen equipment repair costs Includes: • Parts, labor, and travel • One preventative maintenance per year per product advanced issues and preventative maintenance. Includes: • Parts, labor, and travel • One preventative maintenance per year per product • Regulatory documentation • Manufacturer’s parts. • 4-hour call response • Most repairs completed within 24-72 hours • Regulatory documentation • Manufacturer’s parts. Select Partnership • 4-hour call response The Select partnership focuses on the annual preventative maintenance needed for machines each year and is designed to • Most repairs completed within 24-72 hours assist the clinic with overall operational effectiveness. Includes: • One preventative maintenance per year per product • Regulatory documentation PHOENIX X36 Hemodialysis System Specifications Physical Dimensions Blood Handling Height: 56.7 in without IV pole Blood Flow 10 to 530 mL/min Width: 24 in Depth of base: 27.9 in Footprint 671.3 in2 • Non-invasive pressure monitoring • Single Needle option available • H eparin pump 0.0/0.5 to 10.0 mL/h linear infusion Footprint with back shelf: 879.3 in2 Dry Weight 264.5 lb (120 kg) rates; delivery also by automatic or manual bolus • Can accommodate 10, 20, and 30 mL syringes • Ultrasonic Air Bubble Detector can detect bubbles as small as 20 μL • Blood Leak Detector: infrared light detector Electrical Power Supply Requirements Ultrafiltration Rate 115 V ±10%, 60 Hz, 16 A (12 A without heat disinfection) or 230/240 V ±10%, 50/60 Hz, 10 A Range 0.0 to 4.0 kg/h Accuracy ±2% Maximum Total Programmable Target Weight Loss: 30 kg, to be obtained in a linear treatment time of up to 8 hours Water Supply Requirements Refer to both local and AAMI standards for water quality Pressure: 14.5 to 87 psig (100 to 600 kPa) Flow: 1.1 L/min Temperature: 50°F to 90°F (10°C to 32.2°C) Drain Maximum height above floor level: 39.4 in (1 m) Maximum distance 118.1 in (3 m) to drain: Flow: 1.1 L/min maximum Temperature: 203°F max (+95°C max) Dialysate Handling Temperature Range: 93.2°F (+34°C) to 103.1°F 350 to 800 mL/min with steps of 50 mL/min Flow rate accuracy • • • • • • • • • • • Arterial and venous pressure monitoring Color touch screen DIASCAN Monitoring System Compensated blood flow UF and Sodium Profiling Blood Pressure monitoring BICART Cartridge Holder DIACLEAR Ultrafilter Holder Central Concentrate Connection pH Probe Ethernet port standard Options (+39.5°C) Flow rate Included Features ±5% • Battery Backup Kit • Single Needle Contact your local Baxter sales representative to learn more about the product. For Customer Support call 800-525-2623. Rx Only. For the safe and proper use of the device mentioned herein, refer to the appropriate operator’s manual. References: 1. Phoenix Hemodialysis System Operator’s Manual, Rev. B, SW Revision 3.40. Baxter, BiCart, Diaclear, Diascan, Exalis, and Phoenix are trademarks of Baxter International Inc. or its subsidiaries. www.baxter.com USMP/MG115/14-0030(2) 500 10/15 DIASCAN Monitoring System A Quality Assurance Tool1 Plan. Do. Study. Act. Making possible personal. Plan. Do. In the dialysis world, this is the patient’s prescription. The PHOENIX X36 Hemodialysis System and the DIASCAN Monitoring System can help manage a patient’s prescription by providing instant feedback on key items that can assist the clinician in making key decisions regarding the patient prescription. Monitoring Clearance Establish Objectives and Processes Treatment Process As clearance can be affected by issues within the blood circuit, dialysate circuit, or treatment time, even a small change in clearance may impact a treatment.3 Below is an example of induced recirculation due to incorrect needle direction. Clinical Tools By accounting for the negative arterial pressure that is created when pulling blood out of the body, the PHOENIX X36 Hemodialysis System displays the actual blood flow rate next to the pump speed that has an accuracy of +/-10%.*1 The negative pressure can create an 8-15% reduction in the actual blood flow rate and the deviation may reduce the treatment efficacy by the same amount.2 PHOENIX X36 is the only machine on the US market to display the actual blood flow rate which can be used by the clinician to monitor and adjust the therapy. Clearance / Qb ml/min 300 Blood Flow (Y1) 250 400 200 300 150 200 100 100 50 Ionic Clearance The correlation between urea clearance and ionic clearance is roughly equivalent as urea and sodium are of similar molecular weight. The use of ionic clearance can be substituted for urea clearance in this non-invasive tool.3 The ionic clearance is also used in an Ionic Kt/V calculation that can be trended by treatment. (Y2) 0 00:00 01:00 02:00 03:00 Time Clearance (Y1) Threshold (Y1) 04:00 h:min Qb (Y2) Needle Reversal Example4 DIASCAN Monitoring System Introduced over 15 years ago, the DIASCAN Monitoring System has had worldwide clinical use. It measures conductivity on the dialysate side of the dialyzer and calculates two parameters: Ionic Clearance and Plasma Conductivity.1 ml/min 500 Blood Circuit Dialysate Circuit Real Blood Flow Set-Value Pump Occlusion Art / Ven pressure Line-Kinking Needle Size Recirculation Needle Direction4 Access Stenosis Dialyzer Membrane Type Effective Surface Anticoagulation Priming Technique Treatment Time Bypass and UF Only Early Disconnection Multiple Dialysate Alarms Multiple Blood Alarms Dialysate Flow Flow Rate Counter/Co-current Decision tree helps users identify potential patient and treatment issues3 Plasma Conductivity This provides a correlation to the patient’s sodium concentration and can be useful in analyzing the patient’s sodium level during and after treatment.1 Plasma conductivity can be helpful in individualizing sodium prescriptions and when using sodium profiling to manage fluid shift and intra-dialytic hypotensive episodes.3 *If in double needle mode, and when pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is higher, or less negative than -150 mmHg. Monitoring Plasma Conductivity During Sodium Profiling Sodium profiling is one way to manage fluid shift and intra-dialytic hypotensive episodes.3 The ability to track plasma conductivity throughout the treatment can give immediate information for a sodium profile, providing the opportunity to adjust the sodium prescription if needed. Study. Act. Patient & Treatment Trending Analyze the differences to determine the root cause of insufficient dialysis dose and help reduce the treatment variability. Trending Manage Trending the patient’s Kt/V each treatment can assist in identifying trends sooner than in monthly labs. These additional points of reference can help the clinician make an informed decision about every patient. • Determine optimal blood flow • Determine optimal dialysate flow • Monitor patient reaction to prescription Lab Kt/V vs. Kt/V from the Diascan Monitoring System • Monitor and trend Kt/V each treatment • Monitor clearance for treatment issues or vascular access issues 300 250 • Monitor patient reaction to sodium profile 200 Kt/V Diascan Kt/V Lab Kt/V • Monitor patient sodium level and determine optimal sodium prescription 150 100 50 4/02 4/22 5/12 6/01 6/21 Treatment Dates Example of how to trend DIASCAN Kt/V data and Lab Kt/V data Vascular Access Surveillance As blood flow is one of the many reasons for a decreased clearance, one can compare blood flow and clearance for an indication of access recirculation. If the ionic clearance blood flow ratio is less than 50%, it can be an indication of significant access recirculation in patients with an arteriovenous fistulae.5 Trending the patient’s ionic clearance blood flow ratio can help identify potential access stenoses. Use this ratio during every treatment for non-invasive access surveillance with no need for additional disposables or equipment. DIASCAN Monitoring System The PHOENIX X36 Hemodialysis Delivery System is intended to be used to provide high-flux and low-flux hemodialysis, hemofiltration, and ultrafiltration on patients weighing 15 kg or more. With features such as real-time Kt/V monitoring through the DIASCAN monitoring system, compensated blood flow, full-color touch screen, and sodium and UF profiling, the PHOENIX X36 Hemodialysis System is designed to help provide effective hemodialysis therapy. Be proactive with your patient care, not reactive. QAPI Quality Plan Process Treatment Contact your sales representative to learn how the DIASCAN Monitoring System can help manage the treatment data and quality plan processes. QIP Quality Measures Customer Experiences “We started with our DIASCAN in December of 2010 and had about a three-month window there where we just wanted to make sure that we were doing everything that we were supposed to be doing. We didn’t put everything in place at one time, we did it by steps and that was very helpful to the staff....We educated our patients, we educated our doctors, we educated the staff before we actually went out and got started. Not very difficult to implement, it was just a little bit of a process...” - Judy, RN; Good Samaritan, Lebanon, PA “The DIASCAN [sic] has allowed us to very quickly intervene with access problems. The staff will identify a decrease in the online Kt/V and they will report it to the physician or the nurse practitioner quickly and have interventions done within a very short period of time.” - Marianne, RN; Good Samaritan, Lebanon, PA Contact your local Baxter sales representative to learn more about the product. For Customer Support call 800-525-2623. References: 1. Phoenix Hemodialysis System Operator’s Manual, Rev B, SW 3.40. 2. Ward, Blood Flow Rate: An Important Determination of Urea Clearance and Dialysis Kt/V, Adv Renal Replace Ther. Jan. 1999. 3. Henrich W. Principles and Practice of Dialysis, 2009. 4. Daugirdas J, Blake P, Ing T. Handbook of Dialysis, Fourth Ed., p.113. 5. Mohan S, et al. Effective Ionic Dialysance/Blood Flow Rate Ratio: An Indicator of Access recirculation in Ateriovenous Fistuale. ASAIO Journal, September 2010. Baxter, Gambro, Diascan, and Phoenix are trademarks of Baxter International Inc., or its subsidiaries. www.baxter.com USMP/MG115/14-0046(3) 100 10/15