Prismaflex

An integrated system for continuous fluid management and Renal Replacement Therapies.

Operators ManualFor use with software versions 1.07

GAMBRO DASCO S.p.A.Via Modenese, 6641036 Medolla (MO) -Italy

Reorder Service Code 6980486 Rev. AManufacturing P/N 9031945100 Rev. A2005/03

Manufactured by: GAMBRO DASCO S.p.A., via Modenese, no. 66, 41036 MEDOLLA (MO), Italy.

Questions or comments about this publication can be directed to your local representative or to manufacturer.

Copyright GAMBRO LUNDIA AB - 2005. All rights reserved.

Prismaflex is a trademark of GAMBRO LUNDIA AB.

GAMBRO is a registered trademark of GAMBRO LUNDIA AB.

HOSPAL is a registered trademark of GAMBRO HOSPAL SWITZERLAND Ltd.

The Prismaflex machine is protected by one or more of the following patents/patent applications:- U.S. patents: 4861242, 5441636, 5644402, 5722399, 5679245, 5776345, 5910252, 5762805,

5578223, 5725775, 5698090, 5211849;- European patents/patent applications: 0611227, 0611228, 0678301, 0701830, 0829265, 0706044,

0607301;- GB patents: 2208897;- Canadian patents/patent applications: 1284598, 2115414, 2115415, 2158245, 2444794, 2303714,

2119375;- Japanese patents/patent applications: 1772297, 117332/96, 3469287, 315530/94, 3413412,

3140781;- German patents: P-3828123.6;- French patents: 8811046;- Italian patents/patent applications: MI2002A001390, MI2002A001389, MI2003A000214,

MI2003A000212, MI2003A000213, MI2003A000216, MO2003A000165, MI2003A000211, MO2003A000259, MO2003A000293, 1223781;

- International patent applications: PCT/IB03/02281, PCT/IB2004/000055, PCT/IB2004/000062, PCT/IB2004/000105, PCT/IB2004/000061, PCT/IB2004/000104.

the following US patents 4 861 242 ; 5 441 636 ; 5 644 402 ; 5 679 245 ; 5 776 345 ;

Contents

Before You Get Started ........................................................ xiiiIndications ................................................................................................... xiiiContraindications ......................................................................................... xiiiSystem Components ................................................................................... xiii

Control Unit ........................................................................................... xiiiSet ......................................................................................................... xiii

Prismaflex CRRT Sets ................................................................... xivPrismaflex Device Accessories .................................................................... xivMaximum Allowed Bag Sizes and Configurations ....................................... xivWhere to Find Information About the Prismaflex System .............................xv

Operators Manual ..................................................................................xvOn-line Instructions ................................................................................xvInstructions for Use of Prismaflex Sets ..................................................xv

Warnings .......................................................................................................xvPrecautions ................................................................................................ xxiiiSymbols and Certification .......................................................................... xxviDisclaimer .................................................................................................xxviiiService Information .................................................................................... xxixDisposal of Batteries ................................................................................ xxxivDisposal of Packaging Material ............................................................... xxxivWarranty .................................................................................................. xxxiv

Chapter 1: Product Description ............................................. 1Introduction .................................................................................................... 1

Blood Access .......................................................................................... 1Prismaflex Control Unit Functions ........................................................... 1

Therapy Overview ......................................................................................... 2Prismaflex Therapy Options .................................................................... 2

CRRT (Continuous Renal Replacement Therapies) ......................... 2Mechanisms of Therapy .......................................................................... 2

Ultrafiltration ...................................................................................... 2

Prismaflex Operators Manual iii

Hemofiltration .................................................................................... 2Hemodialysis .................................................................................... 3Hemodiafiltration ............................................................................... 3

Prismaflex Control Unit .................................................................................. 5Front Panel .............................................................................................. 5Bottom Panel ......................................................................................... 10Right Side Panel ................................................................................... 10Rear Panel ............................................................................................ 10Interior Components .............................................................................. 13

Self-Tests of the Prismaflex System ............................................................ 13Initialization Test ................................................................................... 14Prime Self-Test ..................................................................................... 15Periodic Self-Test .................................................................................. 19

Subtests .......................................................................................... 20Alarm Monitoring During the Periodic Self-Test .............................. 20

Chapter 2: Installation ...........................................................23Contents of Prismaflex Shipping Carton ...................................................... 23Electrical Requirements ............................................................................... 23Electromagnetic Environment Requirements .............................................. 24Space Requirements ................................................................................... 24Unpacking and Assembly ............................................................................ 24

Materials Needed .................................................................................. 24Step 1: Unpacking ................................................................................. 24Step 2: Connect Power Cord ................................................................ 24Step 3: Install Scale Carrying Bars ........................................................ 26Step 4: Machine Calibrations ................................................................ 26Step 5: Installation Test ......................................................................... 27

Supplies Needed ............................................................................ 27Procedure ....................................................................................... 27

Chapter 3: Continuous Renal Replacement Therapies (CR-RT) ...........................................................................................31Prismaflex CRRT Set ................................................................................... 31System Overview ......................................................................................... 35

Communicating with the Prismaflex Control Unit .................................. 35Interactive Display .......................................................................... 35

iv Prismaflex Operators Manual

User-controllable Settings ............................................................... 36Default Values .......................................................................... 36Current Values ......................................................................... 37Safety Relevant Settings .......................................................... 37

Pumps ................................................................................................... 37Flow Rates and Syringe Pump Settings ................................................ 38

Adjusting the Flow Rates and Syringe Pump Settings ................... 38Viewing the Flow Rate Settings During Treatment ......................... 39PBP Rate and Blood Pump Speed ................................................. 39Ratio of PBP to Blood in the Access Line ....................................... 39Replacement Solution Delivery Options ......................................... 40Total predilution .............................................................................. 41Patient Fluid Removal Rate ............................................................ 41

Calculating the Desired Patient Fluid Removal Rate ............... 42Adjusting the Patient Fluid Removal Rate ................................ 42Machine Control of Patient Fluid Removal Rate ....................