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PRISMA System - CRRTonline

PRISMA SystemAn integrated System for continuous fluid management, renal replacement therapies and therapeutic plasma exchangeOperator s ManualFor use with software versions DASCO Modenese, 6641036 Medolla (MO) -ItalyCatalog Number: 6983217, Rev. AP/N 9032167850, Rev. A2006/09 Manufactured by: GAMBRO DASCO , Via Modenese 66, 41036 MEDOLLA (MO) or comments about this publication can be directed to your local representative or to manufacturer. 1992-1996, 1998 GAMBRO Inc. (unpublished), 2000 2001 Gambro dasco SpA (unpublished), 2001-2006 Gambro Lundia AB (unpublished).

PRISMA® System An integrated system for continuous fluid management, renal replacement therapies and therapeutic plasma exchange Operator’s Manual For use with software versions R03.10

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Transcription of PRISMA System - CRRTonline

1 PRISMA SystemAn integrated System for continuous fluid management, renal replacement therapies and therapeutic plasma exchangeOperator s ManualFor use with software versions DASCO Modenese, 6641036 Medolla (MO) -ItalyCatalog Number: 6983217, Rev. AP/N 9032167850, Rev. A2006/09 Manufactured by: GAMBRO DASCO , Via Modenese 66, 41036 MEDOLLA (MO) or comments about this publication can be directed to your local representative or to manufacturer. 1992-1996, 1998 GAMBRO Inc. (unpublished), 2000 2001 Gambro dasco SpA (unpublished), 2001-2006 Gambro Lundia AB (unpublished).

2 PRISMA is a trademark of GAMBRO INC registered in Argentina, Chile, Mexico, United States, Uruguay. GAMBRO is a registered trademark of GAMBRO LUNDIA is a registered trademark of GAMBRO HOSPAL SWITZERLAND PRISMA machine is protected by one or more of the following patents:- patents: 4861242, 5644402, 5722399, 5679245, 5776345, 5910252, 5762805, 5211849, 5394732;- European patents: 0611228, 0678301, 0701830, 0829265, 0706044, 0607301, 0643301;- GB patents: 2208897;- Canadian patents: 1284598, 2115414, 2303714, 2119375;- Japanese patents: 1772297, 2823513, 3690846, 3591864, 3413412, 3140781;- German patents: 3828123.

3 - French patents: 2619604, 2724321, 2725522;- Italian patents: System Operator s ManualiiiContentsBefore You Get Started .. xixIndications .. xixContraindications .. xixSystem Components .. xixControl Unit .. xixSet .. xxWhere to Find Information About the PRISMA System .. xxOperator s Manual .. xxOn-line Instructions .. xxPRISMA Set Instructions for Use .. xxiWarnings .. xxiPrecautions .. xxviiSymbols and Certification .. xxxiDisclaimer .. xxxiiService Information ..xxxiiiUnited States, Central America, South America Customers.

4 XxxiiiReturning Used Product ..xxxiiiDisposal of Lithium Energy Cell .. xxxivDisposal of Packaging Material .. xxxivWarranty .. xxxivChapter 1: Product Description .. 1 Introduction .. 1 Blood Access .. 1 PRISMA Control Unit Functions .. 1 Therapy Overview .. 2 PRISMA Therapy Options .. 2 Mechanisms of Therapy .. 2 Ultrafiltration .. 2 Hemofiltration .. 3 Hemodialysis .. 3ivPRISMA System Operator s ManualHemodiafiltration .. 3 Therapeutic Plasma Exchange .. 3 PRISMA Control Unit .. 4 Front Panel .. 4 Bottom Panel .. 7 Right Side Panel.

5 7 Left Side Panel .. 7 Rear Panel .. 7 Chapter 2: Installation .. 11 Contents of PRISMA Shipping Carton ..11 Tools, Supplies, and Equipment Required .. 12 Electrical Requirements .. 13 Space Requirements .. 13 Visual Inspection for Damages .. 13 Assembly .. 13 Materials Needed .. 13 Assembly Steps .. 13 Power Supply Check on Power Supply Interface CCA .. 17 Calibrations .. 18 Scales .. 18 Calibration .. 18 Diagnose .. 19 Pressures .. 20 Calibration .. 20 Diagnose .. 20 Reposition Transducer.. 21 Service Mode Checkout.

6 22 Service-Pumps Inspection .. 22 Service-Pumps Diagnose Screen .. 23 Service-Lights and Tones Diagnose Screen .. 24 Functional Checkout .. 25 Setup and Prime .. 26 Fluid Accuracy .. 26 Access Pressure Alarm Verification .. 28 Incorrect Weight Change Alarms .. 28 Excess Pt. Fluid Loss or Gain Alarm .. 29 Fluid Accuracy During Alarm .. 29 Electrical Safety Inspection .. 30 PRISMA System Operator s ManualvWarning Label .. 31 Installation Checklist .. 31 Chapter 3: Continuous Renal Replacement Therapies (CR-RT) .. 33 PRISMA Set for CRRT.

7 33 System Overview .. 36 Communicating With the PRISMA Control Unit .. 36 Interactive Display .. 36 User-controllable Settings .. 36 Default Values .. 36 Current Values .. 37 Pumps .. 37 Flow Rates and Anticoagulant Settings .. 37 Adjusting the Flow Rates and Anticoagulant Settings .. 38 Patient Fluid Removal Rate .. 38 Calculating the Desired Patient Fluid Removal Rate .. 38 Adjusting the Patient Fluid Removal Rate .. 39 Machine Control of Patient Fluid Removal Rate .. 39 Setting the "Excess Pt. Fluid Loss or Gain" Safety Limit.

8 40 Fluid Balance .. 40 Actual Patient Fluid Removed .. 40 Measuring Actual Patient Fluid Removed .. 40 Viewing Actual Patient Fluid Removed .. 41I/O Data .. 41 Treatment History Data .. 42I/O History .. 42 Events History .. 43 History Data After a Treatment .. 43 History Data During a Power Loss .. 43 Alarm Safety System .. 44 Monitoring Systems .. 44 Pressure .. 44 Blood Leak .. 44 Air Bubble .. 44 Operation .. 45 Startup .. 45 Control and Navigation .. 45 Screen Layout .. 46 Operating Modes .. 46viPRISMA System Operator s ManualSetup Mode.

9 46 Standby Mode .. 50 Run Mode .. 51 End Mode .. 53 Change Set Procedure .. 53 End Treatment Procedure .. 54 Temporary Disconnection Procedure .. 55 Custom Mode .. 56 User-controllable Settings .. 57 Anticoagulant Syringe Installation Procedure .. 61 Initial Syringe Installation .. 61 Changing the Syringe During Treatment .. 62 Change Bags Function .. 64 Control Unit Actions .. 64 Changing a Bag During Treatment .. 64 Pressure Monitoring .. 65 Pressure Monitoring Components .. 65 Pressures During Operation .. 66 Extreme Pressure Limits.

10 67 Pressure Operating Points .. 68 Initial Values .. 68 Subsequent Values .. 68 Pressure Trending Limits .. 69 Cannot Detect Disconnection Limits .. 69 Software-calculated Pressures .. 70 Transmembrane Pressure (TMP) .. 70 Filter Pressure Drop (DP Filter) .. 71 Chapter 4: Therapeutic Plasma Exchange (TPE) .. 73 PRISMA TPE Set .. 73 System Overview .. 75 Communicating With the PRISMA Control Unit .. 75 Interactive Display .. 75 User-controllable Settings .. 76 Default Values .. 76 Current Values .. 76 Pumps .. 77 TPE Prescription, Flow Rates, and Anticoagulant Settings.


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