Hospal Prisma Fluid Management System Service manual

PRISMA System

An integrated system for continuous fluid management, renal replacement therapies and therapeutic plasma exchange

Service Manual

For software version R03.10

GAMBRO DASCO S.p.A.

Via Modenese, 66

41036 Medolla (MO) -Italy

Reorder Service Code 6983928 Rev. A Manufacturing P/N 9032168000 Rev. A

2006/09

Manufactured by: GAMBRO DASCO S.p.A., Via Modenese 66, 41036 MEDOLLA (M O) Italy

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

PRISMA® is a trademark of GAMBRO Inc. registered in the United States, Argentina, Chile, Mexico, and Uruguay.

GAMBRO® is a registered trademark of GAMBRO LUNDIA AB. HOSPAL® is a registered trademark of GAMBRO HOSPAL SWITZERLAND Ltd. The PRISMA® machine is protected by one or more of the following patents:

- U.S. 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;

- French patents: 2619604, 2724321, 2725522;

- Italian patents: 122378 1.

Preface

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

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

Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Where to Find Information About the PRISMA System . . . . . . . . . . . . . . . . xiv

Operator’s Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

On-line Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

PRISMA Set Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiii

Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiv

Disposal of Lithium Energy Cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxvi

Disposal of Packaging Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxvi

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxvi

Chapter 1: Introduction

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Blood Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

PRISMA Control Unit Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Therapy Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

PRISMA Therapy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Mechanisms of Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

PRISMA Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Hemofiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Hemodialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Hemodiafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Therapeutic Plasma Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Status Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Pressure Sensor Housings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Peristaltic Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Cartridge Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Air Bubble Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Pump Raceway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Dialysate Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Return Line Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Tubing Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Corner Hooks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Syringe Pump Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

PRISMA® System Service Manual i

Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Effluent Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Bottom Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Scale Hook Assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Right Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Left Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Controller CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Monitor CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Detector CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Hour Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Serial Communication Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Power Distribution CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Power Entry Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Automatic Reposition System (ARPS) . . . . . . . . . . . . . . . . . . . . . . . 1-9

Driver CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Analog CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Jumpers Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Chapter 2: Continuous Renal Replacement and Therapeutic Plasma Exchange Therapies

CRRT System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Interactive Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Default Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Current Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Flow Rates and Anticoagulant Settings . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Adjusting the Flow Rates and Anticoagulant Settings . . . . . . . . . . . 2-6

Patient Fluid Removal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Calculating the Desired Patient Fluid Removal Rate . . . . . . . . 2-6

Adjusting the Patient Fluid Removal Rate . . . . . . . . . . . . . . . . 2-6

Machine Control of Patient Fluid Removal Rate . . . . . . . . . . . 2-7

Setting the "Excess Pt. Fluid Loss or Gain" Safety Limit . . . . . 2-7

Fluid Balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Actual Patient Fluid Removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Measuring Actual Patient Fluid Removed . . . . . . . . . . . . . . . . 2-7

Viewing Actual Patient Fluid Removed . . . . . . . . . . . . . . . . . . 2-8

I/O Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Treatment History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

I/O History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Events History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

History Data After a Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

History Data During a Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Alarm Safety System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

ii PRISMA® System Service Manual

Blood Leak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Air Bubble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

CRRT Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Control and Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Setup Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

End Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Change Set Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

End Treatment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

Temporary Disconnection Procedure . . . . . . . . . . . . . . . . . . . 2-19

Custom Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Anticoagulant Syringe Installation Proced ur e . . . . . . . . . . . . . . . . . . . 2-23

Initial Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

Changing the Syringe During Treatment . . . . . . . . . . . . . . . . . . . . 2-24

Change Bags Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Changing a Bag During Treatment . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Pressure Monitoring Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26

Pressures During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26

Extreme Pressure Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Pressure Operating Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Initial Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Subsequent Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Pressure Trending Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

“Cannot Detect Disconnection” Limits . . . . . . . . . . . . . . . . . . . . . . 2-29

Software-calculated Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Transmembrane Pressure (TMP) . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Filter Pressure Drop (DP Filter) . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

PRISMA TPE Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

System Overview with TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

Communicating With the PRISMA Control Unit . . . . . . . . . . . . . . . . . 2-33

Interactive Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

Default Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

Current Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

TPE Prescription, Flow Rates, and Anticoagulant Settings . . . . . . . . . 2-35

Adjusting the TPE Prescription, Flow Rates, and Anticoagulant

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35

Patient Plasma Loss Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35

Software Calculations of Target Patient Plasma Loss . . . . . . 2-36

Setting the Patient Plasma Loss Rate to Achieve Prescribed

Target Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

Setting the "Excess Pt. Fluid Loss or Gain" Safety Limit . . . . 2-36

Plasma Balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37

Actual Patient Plasma Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37

Measuring Actual Patient Plasma Loss . . . . . . . . . . . . . . . . . 2-37

Viewing Actual Patient Plasma Loss . . . . . . . . . . . . . . . . . . . 2-37

PRISMA® System Service Manual iii

Treatment Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37

Treatment History Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Treatment History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Events History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

History Data After a Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

History Data During a Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

Alarm Safety System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

Blood Leak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

Air Bubble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

TPE Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Control and Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

Setup Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41

SPECIAL PROCEDURE WHEN USING THE ACCESSORY

SP394 WITH THE PRISMA SYSTEM IN TPE MODE . . . . . . 2-42

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45

Run Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46

End Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

Change Set Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

End Treatment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48

Temporary Disconnection Procedure . . . . . . . . . . . . . . . . . . . 2-49

Custom Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50

User-controllable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50

Anticoagulant Syringe Installation Proced ur e . . . . . . . . . . . . . . . . . . . 2-53

Initial Syringe Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53

Changing the Syringe During Treatment . . . . . . . . . . . . . . . . . . . . 2-54

Change Bags Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55

Changing a Bag During Treatment . . . . . . . . . . . . . . . . . . . . . . . . 2-55

Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55

Pressure Monitoring Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56

Pressures During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-56

Pressure Operating Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58

Initial Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58

Subsequent Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-58

Pressure Trending Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

“Cannot Detect Disconnection” Limits . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

Software-calculated Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-59

Access Transmembrane Pressure (TMPa) . . . . . . . . . . . . . . . . . . 2-59

Plasmafilter Pressure Drop

(DP Filter) . . . . . . . . . . . . . . . . . . . . . . 2-60

Chapter 3: Electronic Description

Power System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Monitor CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Monitor CCA Display Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

COM 2 (RS-232 Serial Interface Port) . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

iv PRISMA® System Service Manual

Monitor Watch Dog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Power Fail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Controller CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Touchscreen Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Controller Watch Dog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Detector CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Ultrasonic Air Bubble Detector (UABD) . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Ultrasonic Oscillator and Transmitter Output . . . . . . . . . . . . . . . . . 3-13

Ultrasonic Receiver Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Blood Leak Detector (BLD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Normalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Automatic Reposition System (ARPS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Reposition Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Effluent (TPE Only), Filter, Return Pressure Pods . . . . . . . . . . . . . 3-18

Effluent (CRRT Only), Access Pressure Pods . . . . . . . . . . . . . . . . 3-18

ARPS Electronic Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Driver CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Peristaltic Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Pump Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Return Line Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22

Syringe Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Cartridge Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Status Lights and Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Analog CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25

Pressure Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26

Scale Assemblies (Weight Transducer) . . . . . . . . . . . . . . . . . . . . . . . 3-27

LVDT Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27

Load Cell Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

Return Line Clamp Position Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29

Chapter 4: Software Description

Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Periodic Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Alarm Monitoring During the Periodic Self-test . . . . . . . . . . . . . . . . 4-2

Subtests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Macro Bubble Detector Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Micro Bubble Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

UABD Trouble Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

24 Volt Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Blood Leak Detector Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Pressure Sensor Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Failure of the Periodic Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Prime Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Blood Leak Detector Normalization and Test . . . . . . . . . . . . . . 4-4

TMPa Calibration (TPE Therapy Only) . . . . . . . . . . . . . . . . . . . 4-4

Modified Periodic Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

PRISMA Set Recognition Test . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

PRISMA® System Service Manual v

SCUF Priming Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

CVVH Priming Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

CVVHD Priming Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

CVVHDF Priming Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

TPE Priming Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Diagnose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Lights and Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Syringe Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Load/Unload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Automatic Reposition System . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Service - Internal Functions . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Chapter 5: Service Screens and Calibration

PRISMA Service Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Service Mode Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Calibrate Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Diagnose Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Restart Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Examine Alarms Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Clear Alarms Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Service-Calibrate Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Service-Scales Calibrate Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Calibrating the Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Service-Pressure Calibrate Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Next/Store Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Exit Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Calibrating the Pressure Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Service - Filter Clotting Limits Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

TMP Increase Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Exit Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Service-Set Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Exit Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Service-Set PRISMA ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Setting the PRISMA ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Service-Diagnose Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Service-Pumps Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Testing the Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Direction Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

24 Volts On Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Service-Scales Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

vi PRISMA® System Service Manual

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Service-Pressure Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Enable Reposition Transducer Softkey . . . . . . . . . . . . . . . . . . . . . 5-14

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Service-Lights and Tones Diagnose Screen . . . . . . . . . . . . . . . . . . . . 5-15

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Service-Air Detector Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Macro Test Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Micro Test Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Next Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Service-Syringe Pump Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . 5-17

Continuous Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Stop Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Bolus Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Adjust Rate Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Service-Clamp Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Clamp Command Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Monitor Power and Control Power Softkeys . . . . . . . . . . . . . . . . . 5-18

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18

Service-Blood Leak Detector Diagnose Screen . . . . . . . . . . . . . . . . . 5-19

Test Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Normalize Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Signal 1 and Signal 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Difference and Average . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Service-Pod Reposition Diagnose Screen . . . . . . . . . . . . . . . . . . . . . 5-21

Effluent, Access, Filter, and Return Valve Softkeys . . . . . . . . . . . . 5-21

Motor Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

Direction Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

Pressure and Reposition Press Display . . . . . . . . . . . . . . . . . . . . . 5-22

Next Diagnostic Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Service-Internal Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23

Test Monitor and Test Control Watch Dog Softkeys . . . . . . . . . . . 5-23

Test Video Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23

Set PM Timer Status Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23

Test Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23

Restore Defaults Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24

Exit Softkey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24

Test Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24

Chapter 6: Alarm System and Troubleshooting

Alarm Troubleshooting Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Component and System Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 6-5

Warning Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Overridden Warning Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Overridden Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

PRISMA® System Service Manual vii

Caution Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Overridden Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Component and System Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

Self-test Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-76

Interpreting a Self-test Failure Code . . . . . . . . . . . . . . . . . . . . . . . . . . 6-76

Manual Termination of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-87

Manual Termination With Blood Return . . . . . . . . . . . . . . . . . . . . . . . 6-87

Manual Termination Without Blood Return . . . . . . . . . . . . . . . . . . . . . 6-88

Diaphragm Reposition Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89

Diaphragm Reposition Procedure for CRRT . . . . . . . . . . . . . . . . . . . . 6-89

Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-89

Access and Effluent Pods (CRRT) . . . . . . . . . . . . . . . . . . . . . . . . . 6-89

Filter and Return Pods (CRRT) . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-90

Diaphragm Reposition Procedure for TPE . . . . . . . . . . . . . . . . . . . . . 6-93

Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-93

Access Pod (TPE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-93

Filter, Return, and Effluent Pods (TPE) . . . . . . . . . . . . . . . . . . . . . 6-94

Air Removal Procedures for All Therapies . . . . . . . . . . . . . . . . . . . . . . . . . 6-95

Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-96

Access Pressure Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-96

Return Pressure Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-96

Effluent Pressure Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-96

Filter Pressure Pod/Filter Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-96

Return Line During Air in Blood Alarm . . . . . . . . . . . . . . . . . . . . . . . . 6-97

Component Operation Verification Procedures . . . . . . . . . . . . . . . . . . . . . . 6-98

Syringe Pump Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-98

Syringe Pump Bolus Volume and Delivery Rate . . . . . . . . . . . . . . . . . 6-98

Pump Flow Rate Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99

Pump Flow Rate Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99

Blood Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-99

Effluent Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-100

Dialysate Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-101

Replacement Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-102

Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-103

Pressure Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . 6-103

Pressure Sensor Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-104

Access Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-105

Return Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-106

Filter Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-106

TMP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-107

Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-108

Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-109

viii PRISMA® System Service Manual

Chapter 7: Maintenance

Operator Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Technical Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Tools, Supplies, and Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Visual Inspection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Component Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Power Supply Check on Power Supply Interface CCA . . . . . . . . . . . . . 7-7

Service Mode Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Functional Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Electrical Safety Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Electrical Safety Inspection Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Primary Fusing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Warning Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19

PM Sticker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19

Preventive Maintenance Timer Status . . . . . . . . . . . . . . . . . . . . . . . . 7-19

Preventive Maintenance Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19

Power Supply Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20

Restoring Monitor CCA BBRAMs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21

Pressure Pod Sealing Cones (total 4 of cones) . . . . . . . . . . . . . . . . 7-4

Automatic Reposition System Filter and Pump Segment . . . . . . . . 7-5

Pump Rotor Washers (total of 8 washers) . . . . . . . . . . . . . . . . . . . . 7-5

Service-Pumps Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Service-Scales Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Service Pressure Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Reposition Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Service-Lights and Tones Diagnose Screen . . . . . . . . . . . . . . . . . 7-10

Service-Air Detector Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Service-Syringe Pump Diagnose Screen . . . . . . . . . . . . . . . . . . . . 7-11

Service-Clamp Diagnose Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Service-Blood Leak Detector Diagnose Screen . . . . . . . . . . . . . . . 7-12

Load/Unload Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

Service-Pod Reposition Diagnose Screen . . . . . . . . . . . . . . . . . . . 7-12

Effluent Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12

Access Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Filter Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Return Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Service-Internal Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Setup and Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Fluid Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Access Pressure Alarm Verification . . . . . . . . . . . . . . . . . . . . . . . . 7-16

Incorrect Weight Change Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

Excess Pt. Fluid Loss or Gain Alarm . . . . . . . . . . . . . . . . . . . . . . . 7-17

Fluid Accuracy During Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17

PRISMA® System Service Manual ix

Chapter 8:Illustrated Parts

Chapter 9: Schematics

Chapter 10: Specifications

Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Physical Characteristics of PRISMA Control Unit . . . . . . . . . . . . . . . . . . . . 10-1

AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Anticoagulant Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Flow Rate Ranges and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Flow Rate Ranges and Accuracy (cont.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

TPE Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4

TPE Settings (cont.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Displayed Values Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Displayed Values Accuracy (cont.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(difference between Actual Patient Plasma Loss and displayed value) . . .

Audible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Access Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Access Line Pressure Sensor (cont.) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Return Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Filter Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

Filter Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Effluent Line Pressure Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Air Bubble Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10

10-6 10-6

Appendix A

Note on the combined use of Prisma and the ECG monitoring system . . . . A-1

Appendix B: Fluid Balance Description (CRRT)

Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

How PRISMA Monitors the Flow Rates . . . . . . . . . . . . . . . . . . . . . . B-1

Dialysate, Replacement, and Effluent Fluids . . . . . . . . . . . . . . B-1

How PRISMA Determines “Actual Patient Fluid Removed” . . . . . . . B-1

Protecting the Patient from Fluid Imbalance . . . . . . . . . . . . . . . . . . B-2

“Incorrect Weight Change” Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Excess Pt. Fluid Removed or gained . . . . . . . . . . . . . . . . . . . . B-3

Common Causes of Incorrect Weight Change . . . . . . . . . . . . . B-3

Remedying the Incorrect Weight Change Alarm . . . . . . . . . . . B-3

"Excess Pt. Fluid Loss or Gain Limit" . . . . . . . . . . . . . . . . . . . . . . . . B-3

"Excess Pt. Fluid Loss or Gain" Alarm . . . . . . . . . . . . . . . . . . . . . . . B-4

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

Displayed Values Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5

x PRISMA® System Service Manual

Appendix C: Fluid Balance Description (TPE)

Flow Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1

How PRISMA Monitors the Flow Rates . . . . . . . . . . . . . . . . . . . . . . C-1

Replacement, and Effluent Fluids . . . . . . . . . . . . . . . . . . . . . . C-1

How PRISMA Determines “Actual Patient Plasma Loss” . . . . . . . . . C-1

Protecting the Patient from Fluid Imbalance . . . . . . . . . . . . . . . . . . C-2

“Incorrect Weight Change” Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Excess Pt. Fluid Removed or gained . . . . . . . . . . . . . . . . . . . . C-3

Common Causes of Incorrect Weight Change . . . . . . . . . . . . . C-3

Remedying the Incorrect Weight Change Alarm . . . . . . . . . . . C-3

"Excess Pt. Fluid Loss or Gain Limit" . . . . . . . . . . . . . . . . . . . . . . . . C-3

"Excess Pt. Fluid Loss or Gain" Alarm . . . . . . . . . . . . . . . . . . . . . . . C-4

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

Displayed Values Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5

Index

PRISMA® System Service Manual xi

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xii PRISMA® System Service Manual

Preface

Indications

The PRISMA System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with diseases where removal of plasma components is indicated. All treatments administered via the PRISMA System must be prescribed by a physician.

Contraindications

Preface

There are no known contraindications to continuous renal replacement therapy or therapeutic plasma exchange except those associated with the infusion of replacement fluids.

System Components

The PRISMA System consists of the PRISMA Control Unit and a disposable PRISMA Set. (PRISMA Sets are purchased separately.)

Control Unit

Each PRISMA Control Unit is packaged with the following items:

• Column (hollow pole with flat plate attached to one end)

• Base with casters

• Installation kit

• Calibration weights (2)

• PRISMA System Op er at or’s Manual

Set

PRISMA

Use only PRISMA Sets (manufactured by GAMBRO or HOSPAL) with the PRISMA Control Unit. Check with your sales representative for availability.

Two types of disposable sets may be used for CRRT (Continuous Renal Replacement therapies), which include SCUF, CVVH, CVVHD, CVVHDF.

System Service Manual xiii

Preface

• Post-dilution set (provides for addition of replacement solution after blood leaves the filter).

• Pre-dilution set (provides for addition of replacement solution before blood enters the filter).

A third type of disposable set, the PRISMA TPE Set, must be used for the TPE therapy.

PRISMA Sets come with an effluent bag. To facilitate priming, a prime collection bag is preconnected to each set. Additional PRISMA Effluent Bags can be purchased separately.

Where to Find Information About the PRISMA System

Operator’s Manual

The PRISMA Operator’s Manual provides installation, operating, maintenance, and troubleshooting instructions, as well as general information. Specific information about system overview, operation, and pressure monitoring fo r CRR T can be found in Chapter 3 and for TPE in Chapter 4 . See th e Co ntent s section for a complete list of topics.

Warnings

On-line Instructions

Detailed operating instructions are incorporated in the software of the PRISMA Control Unit. The instructions are available on-line, through the inte ractive display. Instructions include the following screens:

• Operating screens (step-by-step instructions the operator follows each time in setting up, administering, and ending patient treatments).

• Alarm screens (instructions if an alarm situation occurs).

• Help screens (additional information about an Operating or Alarm screen).

PRISMA Set Instructions for Use

Instructions for use are provided with PRISMA Sets.

1. Carefully read the PRISMA System Operator’s Manual and the PRISMA Set

Instructions for Use before operating this device. Before first use, ensure that the installation test has been successfully performed. See the Installation chapter of the PRISMA System Operator’s Manual for instructions on performing the installation test.

2. Operate this device only in accordance with the procedures contained in the

PRISMA System Operator’s Manual, the PRISMA Set Instructions for Use,

xiv PRISMA

System Service Manual

Preface

and the on-line instructions. The use of operating or maintenance procedur es other than those published by the manufacturer, or the use of accessory devices not recommended by the manufacturer, can result in patient injury or death.

3. The manufacturer will not be responsible for patient safety if the procedures to

operate, maintain, and calibrate the PRISMA System are other than those specified in the PRISMA System Operator’s Manual, this PRISMA System Service Manual, the PRISMA Set Instructions for Use, and the on-line instructions. Anyone who performs the procedures must be appropriately trained and qualified.

4. Ensure that the proper PRISMA Set has been chosen for the selected

therapy. Using the wrong set for the therapy can cause patient injury or death.

5. All electrical installations must comply with all applicable local electrical codes

and the manufacturer’s specifications.

6. The PRISMA Control Unit weighs approximately 23 kg (50 lb). Use at least

two people to lift it out of the shipping carton. Handle the control unit carefully.

7. Use only PRISMA Sets manufactured by GAMBRO or HOSPAL with the

PRISMA Control Unit. The use of non-PRISMA sets can result in patient

injury or death.

8. Do not connect a patient to the PRISMA System during the installation test.

Be sure that the test is conducted using a container of water to substitute for the patient.

9. If a Malfunction alarm occurs during the installation test, the PRISMA Control

Unit has failed the test. Do not use the control unit. Call a trained and qualified technician for service.

10. Use only prescribed dialysate solution and replacement solution/fluid with the

PRISMA System. Use only dialysate solution and replacement solution/fluid which conform with applicable national registr ation, standards, or laws and the Council Directive 65/65/EEC. If a commercially avaliable replacement solution is used, it must be labeled as intended for intravenous injection.

1 1. Only replacement solutions in bags of maximum 5 liters may b e placed on the

replacement scale.

12. Ensure that dialysate solution and replacement solution/fluid are of

appropriate composition and at appropriate temperature, as prescribed by a physician. Before using a solution/fluid, make sure it is free of precipitates an d other particulate matter. The use of incorrect solution/fluid can result in

patient injury or death.

PRISMA

13. To assure proper anticoagulant flow control, use only 20-cc BD, Braun,

Monoject, or Terumo luer lock syringes. The internal diameter of these

syringes has been verified at the time of printing this manual. The manufacturer of the PRISMA System cannot be held liable for subsequent changes that may occur to syringe dimensions. See Anticoagulant Settings in the Specifications chapter for verified internal diameters.

System Service Manual xv

Preface

14. Us e only luer lock syringes with the PRISMA System. Use of non-luer lock

syringes can result in patient blood loss if the anticoagulant line becomes

dislodged from the syringe. See #12 (above) for the list of approved syringes.

15. Do not hang anything except fluid bags/containers from the scale hooks on

the bottom of the PRISMA Control Unit. Foreign objects on the scale hooks can significantly alter fluid balance, resulting in patient injury or death.

16. Do not support the fluid bags/containers by any means other than the

provided scale hooks. Fluid balance can be significantly altered, resulting in patient injury or death. When hanging a fluid bag, always center it on the 3hook assembly, so that its weight is evenly distributed.

17. Lock brakes on casters to limit movement of the control unit that might pull on

tubing connected to the patient.

18. All blood and fluid flowpaths of the set are sterile and nonpyrogenic. Use

aseptic technique when handling the blood and fluid lines in the set.

19. During priming and operation, observe closely for leakage at joints and

connections within the set. Leakage can cause blood loss or air embolism. If leakage cannot be stopped by tightening the connections, replace the se t.

20. Do not allow air to enter the blood compartment of the filter after priming has

started. If a large amount of air enters, the set must be replaced.

21. Do not connect a blood heater to the return line below the air bubble detector .

The PRISMA System cannot detect air introduced in the line below the air detector.

22. If a patient is not connected to the PRISMA Set for CRRT (pre- or post-

dilution) shortly after priming is complete, flush the set with at least 500 ml priming solution (saline with heparin added) before connecting a patient. This requires use of a new bag of priming solution and a new (empty) collection bag.

23. If a patient is not connected to the PRISMA TPE Set shortly after priming is

complete, flush the set with at least 250 ml priming solution (saline with heparin added) before connecting a patient. This requires the use of a new bag of priming solution.

24. Ensure proper functioning of the display and software by confirming the

correct sequence of the numbers on the Prime Test Passed screen. If the numbers displayed are not in sequential order, manually unload the set and call for service—do not connect a patient.

25. All lines in the PRISMA Set have a preattached slide clamp. Clamp the

following lines after priming is complete and before starting a patient treatment (Run mode). For SCUF and CVVHD, clamp the replacement line;

for SCUF and CVVH, clamp the dialysate line; for TPE, clamp the cle ar segment of the access line; for all therapies, clamp the anticoagulant line (if not in use).

26. Connect the PRISMA Set to a patient via venous blood access and return

devices. A dual-lumen venous catheter is the recommended blood access device; however, two single-lumen venous catheters can also be used.

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27. During a patient treatment, ensure the display is operating correctly by

checking the following functions:

a. Numbers on the Set TPE Prescription, Set Flow Rates, and Modify

Anticoag screens should scroll in correct increments and in sequential order when the arrow keys are pressed. (If the increment or sequence is incorrect, terminate the treatment and call for service. See the Specifications chapter for a list of the correct increments.)

b. A short beeping sound should be generated each time a softkey is

pressed. (If a beep is not generated, terminate the treatment and call for service.)

28. Due to the nature of use of the PRISMA Set (low blood flow rate, extended

treatment time, and other special factors), the possibility for coagulation within the blood flowpath is substantially enhanced. Give careful attention to the possible medical hazards associated with coagulation of the blood flowpath.

29. Closely monitor the patient’s clotting p arameters, especially when increasing

the amount of anticoagulant delivered or after changing the anticoagulant syringe.

30. Weigh the patient daily, or as appropriate, to assure proper fluid balance.

Monitor the patient’s blood chemistry as often as necessary.

31. Collecting blood samples from improper sample sites in the set can lead to

incorrect blood chemistry results.

32. When responding to any alarm, carefully follow the instructions on the

displayed Alarm screen and its associated Help screen.

33. The blood leak detector must be re-normalized if the effluent line is

repositioned or removed and then reinser ted into the blood leak detector af ter treatment (Run mode) has started. This is done by pressing the NORMALIZE BLD softkey on the More Softkeys screen. The detector must be renormalized before continuing a patient treatment.

34. To clear some alarms, the PRISMA Control Unit must override the alarm for

60 seconds. The Alarm screen on the display notifies the operator that the alarm will be overridden if the OVERRIDE softkey is pressed. A new alarm for the same condition cannot occur during the override period; therefore, carefully observe the set and all operation during the override period. If the alarm condition is still present after the override period, the control unit issues a new alarm.

35. The control unit may not be able to detect disconnections of the set from the

patient’s catheter (in all therapies), from the red segment of the access line (for TPE), or from the clear segment of the access line (for TPE). Carefully observe the set and all operation while using the PRISMA Syste m for a patient treatment.

PRISMA

36. The PRISMA Set must be changed after 72 hours of use. Continued use

beyond 72 hours could result in rupture of the pump segments, with patient injury or death.

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Note: To assure adequate filter performance, it is recommended that the

PRISMA Set be changed after 24 hours of use. An Advisory alarm occurs if the set is not changed after 72 hours. The operator can reset this advisory to occur between 24 and 72 hours of operation.

37. Always inspect the blood flowpath for signs of clotting before returning the

blood in the set to the patient (via the automatic Return Blood option, or the Manual Termination With Blood Re turn proce dure). If clottin g is suspected, do not return the blood to the patient.

38. If power is lost to the PRISMA Control Unit, the patient can be manually

disconnected from the set. If performing a Manual Termination With Blood Return, visually check for air in the blood return line until the patient is disconnected.

39. If the display goes blank while power is on, immediately terminate the

treatment and call for service.

40. During TPE therapy, in order to avoid hemolysis the pressure gradient

between arterial inlet and filtrate outlet should be strictly controlled and the blood flow rate should not fall below 100 ml/min. Carefully observe the set for signs of hemolysis.

41. To minimize the risk of hemolysis in TPE therapy, the PRISMA System

monitors the TMPa and issues alarms if maximum pressure limits are reached. When performing TPE, additional monitoring for hemolysis is also recommended.

42. It is advisable to obtain a detailed drug history before each TPE procedure.

For drugs potentially affected by TPE, the physician should either adjust the doses or give the medications immediately after the procedure.

43. Renal replacement therapy with high-permeability hemofilters may reduce the

concentration of therapeutic drugs in the patient. The prescribing physician should consult the literature of the drug manufacturer for further information and consider the need to monitor the concentration of the drug in order to assure an appropriate therapeutic dosage.

44. Use only the PRISMA RS232 Cable Kit for communicating with external

equipment. All external equipment must be IEC 60950 compliant.

45. Use only GAMBRO or HOSPAL approved accessories.

46. Electrically isolated peristaltic pumps such as those on the PRISMA System

can produce electrostatic charges in the disposable set. While these electrostatic charges are not hazardous to the patient, they may cause an artifact on cardiac monitors (such as ECG) or pacemaking devices. If a cardiac dysrhythmia is exhibited, press the STOP softkey on the PRISMA System and reassess the cardiac rhythm before treating the patient. To significantly reduce the likelihood of producing artifacts, follow the instructions given in Appendix A of this manual.

47. To reduce the risk of contact between the pump rotors and the patients and

operators, it is recommended to wear properly fastened coats and gather up hair in suitably sized caps. Also be careful with ties, bracelets, necklaces and anything else that may get caught up in PRISMA.

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48. Ignoring and/or indiscriminately pressing the CONTINUE softkey as a

response to alarms of "INCORRECT WEIGHT CHANGE DETECTED" may lead to incorrect patient weight loss or gain, and may result in serious patient injury or death.

Always identify and solve the originating cause of an "Incorrect Weight Change Detected" alarm before pressing the CONTINUE softkey.

49. If you receive additional "Incorrect Weight Change Detected" alarms and the

cause cannot be identified, you should first solve the problem, and then consider discontinuing and restarting the treatment, if possible.

50. The Displayed Actual Patient Fluid Removed/Pati ent Plasma Lo ss will be

less than the one calculated from the "operator-set" Patient Fluid Removal/ Patient Plasma Loss and the Elapsed time shown in the Status screen (this applies also in the History screen) if:

(a) treatment is voluntarily stopped and then later resumed; or (b) an alarm occurs that stops the replacement, dialysate a nd ef fluent pumps . "Operator-set" Patient fluid removed shall be calculated multiplying Run Tim e

in History screen by Patient fluid removal rate. Additional Stop/Restarts ( event ) for bag changes when not completely full/

empty may add 1ml more for each event.

Precautions

1. Procedures using the PRISMA System must be perfo rm e d un de r th e

responsibility of a physician.

2. There are no operator-serviceab le parts inside this device. Re pairs must be

performed by a trained and qualified technician.

3. Store the PRISMA Set in a dry place, between 0 °C (32 °F) and 30 °C

(86 °F).

4. Prior to using the PRISMA Control Unit, let the unit rest at amb ien t op e ratin g

temperature for 1 hour.

5. The rear handle of the PRISMA Control Unit is intended only for pushing the

unit on its casters; the handle is not intended for lifting the unit.

6. The accuracy of the PRISMA Control Unit depends on accurate scale and

pressure calibration. Ensure that scales and pressure sensors are accurately calibrated. Calibrations must be performed by a trained and qualified person. Calibration instructions are provided in this PRISMA System Service Manual.

7. Some solvents and chemicals, if used in contact with the filter, could damage

the PRISMA Set. No chemical of this type should be used without permission of the manufacturer. The following are especially forbidden: (a) halogenated aromatic and aliphatic solvents; (b) ketonic solvents.

PRISMA

8. To prevent contamination, the PRISMA Set must be used as soon as its

package and sterilization caps are removed.

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9. Do not use the PRISMA Set if the package is damaged, if the sterilization

caps are missing or loose, or if the blood lines are kinked.

10. Destroy the PRISMA Set after a single use, using appropriate procedures for

potentially contaminated material. Do not resterilize.

11. When handling PRISMA Sets, hospital personnel should take adequate

precautions at all times to prevent exposure to or transmission of HIV, hepatitis virus, or other infectious agents.

12. The PRISMA System is not designed for a heater to be connected to the

replacement solution line. A heater generates air bubbles which collect in the return line pressure pod. Therefore, it is recommended not to use a heater on the replacement solution line.

13. If a heater is connected to the dialysate line, the PRISMA System does not

automatically prime the additional tubing needed for the heater. Separate priming of this tubing is required.

14. Do not use any type of lubricant on the internal or external components of the

PRISMA Control Unit or PRISMA Set. Use of lubricant can adversely affect performance of the control unit.

15. If anticoagulation of the blood flowpath is not desired, fill a 20-cc BD, Braun,

Monoject, or Terumo luer lock syringe with priming solution and load it into the syringe pump during Setup mode, while the Prepare Solutions screen is on the display. This assures the anticoagulant line will be primed during the automatic priming cycle.

16. After priming is complete, do not remove the pressure pods from the pressure

sensor housings. Pressure sensing becomes inaccurate if pods are r emoved, or if they are removed and then re insert ed in the sensor h ousin gs. If p ods are removed, the set must be changed or the Diaphragm Reposition procedure must be performed.

17. Press only one softkey at a time. Pressing two or more softkeys

simultaneously causes the PRISMA Control Unit to ignore all except the first keypress.

18. Change fluid bags/containers when the appropriate Caution alarm occurs

(Replacement Bag Empty, Dialysate Bag Empty, Effluent Bag Full, Replacement Container Empty). Changing a bag before the alarm occurs may only be done by using the Change Bags function an d following the instructions on the Change Bags screen. When changing bags/containers during TPE therapy, it is important to enter the new replacement container volume on the Change Bags screen. If the volume for the replacement co ntainer is wrong , air could be introduced into the set.

19. For priming in the TPE therapy, the plasma filter specification requires four

priming cycles. Instructions are provided via the on-line screens.

20. During the initialization test, when the PRISMA Control Unit is first turned on,

Service mode can be accessed by pressing certain softkeys simultaneously. Only trained and qualified technicians should access Service mode. If Service mode is inadvertently entered, turn the unit off, then on to return to Operating mode.

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21. Use a 20-gauge (or smaller diameter) needle to obtain bloo d or fluid sample s,

to remove trapped air from the PRISMA Set, or to re position po d diaph ragms. Use of larger needles can cause holes in the sample sites, resulting in blood loss or air embolism. Use aseptic technique whenever inserting needles into sample sites.

22. When repositioning pod diaphragms, injecting or removing more than

1 cc of fluid may move the diaphragm be yond the center point of the pod. See “Diaphragm Reposition Procedure” in Chapter 6: Alarm System and Troubleshooting for more information.

23. When operating the PRISMA System, avoid bumping the cartridge of the

PRISMA Set. Bumping may cause the pump segments to become dislodged in the raceways of the pumps and result in loss of pump effectiveness. If this happens, a variety of alarms will occur to alert you. These include the Caution: Effluent Weight, Caution: Replacement Weight, Caution: Dialysate Weight, Advisory: Return Pressure, and Advisory: Access Pressure alarms.

24. Hemofiltration (CVVH) with high replacement solution flow rates can result in

transmembrane pressures (TMP) which may be sufficiently high to cause one of the following alarms: Warning: Filter is Clotted; Caution: TMP Excessive; Advisory: Filter is Clotting; Advisory: TMP Too High. If these alarms occur, reduce the replacement solution flow rate until the alarm no longer appears. Use of predilution sets with the largest surface area filter available will minimize occurrence of these alarms.

25. If the room temperature changes by more than ± 3° C (5.4 °F), STOP the

treatment and call service to recalibrate the scales . Do not continue to use the PRISMA Control Unit until the scales are recalibrated.

26. As treatment proceeds, carefully monitor patient fluid balance levels and all

the I/O Data on the Status and History screens. Fluid balance monitoring should include frequent totaling of patient fluid input/output and periodic verification of the patient's weight using an independent (non-PRISMA) means.

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Preface

Symbols and Certification

If applicable, the following symbols appear on or near the serial number label or other permanently affixed labels of this device. See the Specifications chapter for more information.

1. This symbol indicates that the equipment applied part is Type BF, defibrillation-proof per IEC 601.1.

2. This symbol indicates that consultation of the accompanyin g document s prior to equipment operation is critical to the safe operation of the device.

IPX1

3. This symbol indicates that the device meets the “drip proof” classification requirements of IEC 601.1 under the applicable conditions.

4. This symbol indicates that the device requires an alternating supply current.

5. This symbol indicates that conductors carrying high voltage are nearby and that these could be hazardous if contacted.

6. This symbol is located near functional ground locations on this device.

7. This symbol is located near protective ground locations on this device.

8. This symbol identifies the point of connection of a potential equalization conductor.

9. This symbol indicates a fuse.

10. This symbol indicates that certain components within this equipment are sensitive to electrostatic discharge.

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Disclaimer

11. This symbol indicates that the equipment conforms to Council Directive 93/42/EEC, of 14 June, 1993 relating to Medical Devices. Also indicates that the notified body which has approved the manufacturer’s quality system is the British Standards Institution (BSI). The CE Mark affixed to the PRISMA Control Unit covers only the PRISMA Control Unit. Disposables specified for use with the PRISMA Control Unit have separate CE Marks. See Warning number 7.

The manufacturer (and/or subsidiaries) accepts responsibility for the safety, reliability, and performance of this equipment only if all operational procedures, calibrations, and repairs are carried out by appropriately trai ned and qualified people; if all equipment modifications are authorized in writing by the manufacturer and carried out by appropriately trained and qualified people; if the electrical installation of the relevant room complies with all applicable local electrical codes and, if applicable, IEC requirement s; and if the equipment is used in accordance with the published instructions for use (this document).

The manufacturer (and/or subsidiaries) will provide on request, at nominal cost, a service manual which contains all necessary circuit diagrams, component parts lists, calibration instructions, and service information to enable appropriately trained and qualified technical personnel to repair those parts of this equipment which the manufacturer considers to be repairable.

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System Service Manual xxiii

Preface

Service Information

For technical assistance, contact your representative at the applicable address below.

AUSTRALIA GAMBRO PTY Ltd.

AUSTRIA HOSPAL Medizintechnische Produkte

P.O. Box 6604 BHBC Baulkham Hills 3, Hudson Avenue Castle Hill NEW SOUTH WALES 2154 Tel. 61 - 2 9 680 27 11 Fax 61 - 2 9 634 13 75

GmbH Ricoweg 30 A A-2351 Wr. NEUDORF Tel. 43/2.23.664.666 Fax 43/2.23.664.666-55

BELGIUM HOSPAL S.A.

Groenveldstraat, 11 B - 3001 HEVERLEE Tel. 32 / 16 31 10 20 Fax 32 / 16 31 10 39

BRAZIL GAMBRO do Brasil Ltda

Avenida Luiz Carlos Berrini 1297 Conjunto 92 BR-04571 SAO PAOLO Tel. 55 - 11 55 06 90 12 Fax 55 - 11 55 06 47 04

CANADA HOSPAL GAMBRO Inc

9157, du Champ D´eau Street St. Leonard CA-QUEBEC H1P 3M3 Tel. 1 - 514 327 16 35 Fax 1 - 514 327 08 22

FRANCE HOSPAL SA

61 av. Tony Garnier F - 69007 Lyon Tel. 33 / (0) 4 37 28 11 11 Fax 33 / (0) 4 37 28 11 44

GERMANY Gambro HOSPAL GmbH

Lochhamer Str. 15 D - 82152 Planegg-Martinsried Tel. 49 / (0) 89. 89933-0 Fax 49 / (0) 89. 89933-2999

xxiv PRISMA® System Service Manual

ITALY HOSPAL SpA

Via Ferrarese, 219/9 I - 40 128 Bologna Tel. 39 / 051 63 82 411 Fax 39 / 051 32 74 77

NETHERLANDS GAMBRO HOSPAL BV

Franse Akker 1 NL - 4824 AL BREDA Tel. +31 / (0) 76 530 3600 Fax +31 / (0) 76 541 1968

Preface

MEXICO

SP AIN HOSP AL SA

SWITZERLAND HOSP AL GAMBRO SCHWEIZ AG

UNITED KINGDOM HOSPAL GAMBRO Ltd

REST of EUROPE , AFRICA & MIDDLE EAST

GAMBRO de MEXICO S.A. de CV Vasco de Quiroga 1900, Piso 3 MX-Santa Fe MEXICO D. F. 01210 Tel. 52 - 52 92 31 00 Fax 52 - 52 92 31 13

Nápoles, 249 - 1° E - 08013 Barcelona Tel. 34 / 93 457 00 74 Fax 34 / 93 457 76 72

Sägereistrasse 24 CH - 8152 GLATTBRUGG Tel. 41/ 1 828 82 82 Fax 41/ 1 828 82 83

Unit 1, Ermine Business Park Huntingdon GB-CAMBRIDGESHIRE PE18 6YA Tel. 44 / 1480 444 000 Fax 44 / 1480 434 084

HOSPAL GAMBRO EXPORT Magistratsvagen 10 P.O. Box 10101 S - 220 10 Lund To order Parts : Fax 46/46 169 610 Middle East: Tel. 46/46 169 134 Africa: Tel. 46/46 169 270 Russia: Tel. 46/46 169 171 East Europe: Tel. 46/45 169 171

PRISMA® System Service Manual xxv

Preface

Disposal of Lithium Energy Cell

The PRISMA Control Unit contains a lithium energy cell. The cell is embedded in a semiconductor on the monitor circuit card assembly. When replacing this component, follow local regulations for proper disposal.

Disposal of Packaging Material

The PRISMA Control Unit shipping carton, foam packing, and other packaging material should be disposed of according to local regulations.

Warranty

Since GAMBRO DASCO has no knowledge or control of how non-GAMBRO DASCO service work is conducted or what effect such work will have on a machine’s operation and performance, GAMBRO DASCO will in no way be responsible or liable for any damages resulting from the operation or performance of any device, or any injury caused thereby, after repairs have been attempted by anyone other than a factory representative of GAMBRO DASCO.

Under no circumstances will GAMBRO DASCO be liable for indirect or consequential damages of any kind, its liability being hereby limited solely to repair or replacement.

This warranty is in lieu of any other expressed or implied warranties, including an y implied warranty of salability or fitness for use and of any other obligation on the part of GAMBRO DASCO.

xxvi PRISMA

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Chapter 1: Introduction

Introduction

Blood Access

PRISMA Control Unit Functions

This service manual is for service technicians who will maintain and repair the PRISMA and understand the content s of this manual before attemp ting to repair or maintain the machine. Only trained and qualified service technicians should perform the procedures described in this manual.

The PRISMA System provides continuous fluid management, renal replacement therapies, and therapeutic plasma exchange (as an option). The system is intended for patients who have acute rena l failure and/or fluid overload, or p atients with diseases where removal of plasma components is indicated.

All PRISMA therapies use venous blood access and return. A dual-lumen venous catheter is the recommended blood access device; however, two single-lumen venous catheters can also be used.

Control Unit. It is important that the service technician thoroughly read

The PRISMA Control Unit performs the following functions:

• Loads and primes the PRISMA Set automatically.

• Pumps blood through the blood flowpath of the set.

• Delivers anticoagulant solution into the blood flowpath.

• Controls fluid removal/plasma loss from the patient.

• Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps

• Monitors the system and alerts the operator to abnormal situations through

Therapy Overview

The PRISMA Control Unit pumps venous blood from the patient, through the filter in a disposable PRISMA Set, and back to the patient’s venous circulation. As the blood passes through the filter, fluid removal/plasma loss and/or solute clearance can take place.

PRISMA

System Service Manual 1-1

effluent.

alarms.

Chapter 1: Introduction

PRISMA Therapy Options

The PRISMA System provides continuous fluid management, four different continuous renal replacement therapies (CRRT), as well as therapeutic plasma exchange (TPE) therapy. During the Setup procedure, the operator selects the therapy desired.

• SCUF (Slow Continuous Ultrafiltration) Provides patient fluid removal by ultrafiltration.

• CVVH (Continuous Veno-venous Hemofiltration) Provides solute removal by convection. Can provide patient fluid removal, if

desired.

• CVVHD (Continuous Veno-venous Hemodialysis) Provides solute clearance by diffusion. Can provide patient fluid removal, if

desired.

• CVVHDF (Continuous Veno-venous Hemodiafiltration) Provides solute removal by both convection and diffusion. Can provide patient

fluid removal, if desired.

• TPE (Therapeutic Plasma Exchange; optional) Provides plasma exchange by membrane filtration.

Mechanisms of Therapy

The mechanisms of ultrafiltration, hemofiltration, hemodialysis, and therapeutic plasma exchange are used in providing the PRISMA therapy options.

Ultrafiltration

In ultrafiltration, plasma water with solutes is pulled from the patient’s blood across the semipermeable membrane in the filter. The effluent pump automatically controls the ultrafiltration rate.

Hemofiltration

In hemofiltration, plasma water with solutes is pulled from the patient’s blood across the semipermeable membrane by means of ultrafiltration. A replacement solution is simultaneously infused into the blood flowpath.

The replacement solution adds back some or all of the water removed, as well as the wanted solutes. Unwanted solutes are not replaced, thus their concentration decreases in the patient’s blood. Solute removal is achieved by convection (solvent drag across the membrane).

Hemodialysis

In hemodialysis, unwanted solutes pass from the patient’s blood across the semipermeable membrane and into dialysate flowing at counter flow through the fluid compartment of the filter.

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+ 312 hidden pages

Hospal Prisma Fluid Management System Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual