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