Prismaflex Operators Manual sw ver 8.xx April 2015

© 2005–2015 Gambro Lundia AB. All rights reserved. Trademarks Gambro, Prismaflex, Adsorba, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX, diaMARS, X-MARS, septeX, oXiris, Hospal, MARS and PrismaLung are trademarks belonging to the Gambro Group. Manufacturer Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden Phone +46 46 169000 www.gambro.com Questions or comments about this publication can be directed to your local representative or to the manufacturer.

G5036007 Revision 04.2015 Program version 8.XX

Table of contents 1

Before you get started ... 15 1.1 General information ... 16 1.1.1 Intended use... 16 1.1.2 Contraindications... 16 1.1.3 Keywords used in this manual... 16 1.2 Where to find information... 17 1.2.1 Operator's manual ... 17 1.2.2 Online instructions ... 18 1.2.3 Instructions for use of Prismaflex® disposable sets ... 18 1.3

Therapies... 18

1.4

Anticoagulation methods ... 19

1.5

Responsibility and disclaimer... 19

1.6

Safety definitions... 20

1.7 General warnings and cautions ... 20 1.7.1 Warnings... 20 1.7.2 Cautions ... 26 1.8 Symbols... 28 1.8.1 About symbols ... 28 1.8.2 Electrical safety ... 28 1.8.3 Instructions and warnings... 28 1.8.4 Information... 29 1.8.5 Communication... 29 1.8.6 Environmental... 29 1.8.7 Transportation and storage ... 30 1.8.8 Solutions... 30 1.8.9 Certification marks... 30 1.9

Installation, service and transport ... 31

1.10 Disposal ... 31 1.10.1 Disposal of packaging material... 31 1.10.2 Disposal of discarded equipment ... 31 1.10.3 Hazardous substances ... 32 1.10.4 Disposal of waste batteries and accumulators ... 32 2

Description of the Prismaflex® system... 35 2.1

System components ... 36

2.2 Prismaflex® control unit ... 36 2.2.1 Control unit functions... 36 2.2.2 Control unit package contents ... 36 2.2.3 Front panel components... 38 2.2.3.1 Pumps ... 38 2.2.3.2 Pressure components... 40 2.2.3.3 Sensors and clamps ... 42

G5036007 Revision 04.2015 Program version 8.XX

2.2.3.4 Scale components ... 44 2.2.3.5 Miscellaneous components ... 46 2.2.4 Rear panel components ... 48 2.2.5 Stand with drip tray... 50 2.2.6 Stand without drip tray... 51 2.2.7 Interior components... 51 2.3 Disposable sets ... 51 2.3.1 About Prismaflex® disposable sets ... 51 2.3.2 Low and high flow sets ... 52 2.3.3 Minimum patient weight... 52 2.3.4 Disposable set components ... 53 2.4 Prismaflex® accessories ... 56 2.4.1 About Prismaflex® accessories... 56 2.4.2 Hardware accessories ... 56 2.4.2.1 Blood warmers... 56 2.4.2.2 HP cartridge holder... 56 2.4.3 Disposable accessories... 56 2.4.3.1 Effluent bag ... 56 2.4.3.2 Calcium infusion line... 56 2.4.3.3 SP-394 accessory for TPE ... 57 2.4.3.4 Prismatherm II extension line ... 57 3

General Prismaflex® functions ... 59 3.1 Blood flowpath management ... 61 3.1.1 Parts of the blood flowpath ... 61 3.1.2 Blood access monitoring ... 61 3.1.3 Blood pump flow rate... 62 3.1.4 Pressure management ... 62 3.1.4.1 How pressure management works ... 62 3.1.4.2 Components for access, filter, and effluent monitoring... 62 3.1.4.3 Components for return pressure monitoring... 63 3.1.4.4 Pressures during operation ... 63 3.1.4.5 Extreme pressure limits ... 63 3.1.4.6 Pressure operating points... 64 3.1.4.7 “Cannot detect disconnection” limits... 65 3.1.4.8 Software-calculated pressures ... 65 3.1.4.9 Filter pressure drop (pressure drop)... 66 3.2 Fluid management... 66 3.2.1 How fluid management works ... 66 3.2.2 Pumps and scales ... 67 3.2.3 Solution bags and containers ... 67 3.2.4 Empty bag methods... 67 3.2.4.1 Fluid bags and containers ... 67 3.2.4.2 Effluent bag ... 68

G5036007 Revision 04.2015 Program version 8.XX

3.3 Flow problems ... 68 3.3.1 Protecting from flow problems ... 68 3.3.2 Detection of flow problems ... 68 3.3.3 Resolving flow problem alarms ... 69 3.4 Air management ... 69 3.4.1 Description... 69 3.4.2 Deaeration chamber monitoring ... 69 3.4.3 Changing the fluid barrier ... 69 3.5

Anticoagulation methods ... 69

3.6 Treatment preparation... 70 3.6.1 Set loading and identification ... 70 3.6.2 Set priming ... 70 3.7 Alarm and monitoring systems... 71 3.7.1 Alarm system... 71 3.7.2 Monitoring systems... 71 3.7.2.1 Pressure ... 71 3.7.2.2 Blood leak... 71 3.7.2.3 Air bubble ... 71 3.7.2.4 Flow rates and volumes ... 71 3.7.2.5 Fluid leak detector ... 71 3.8 Self-tests of the Prismaflex® system ... 72 3.8.1 About self-tests of the Prismaflex® system ... 72 3.8.2 Initialization test ... 72 3.8.3 Prime self-test... 72 3.8.4 Periodic self-test ... 72 3.8.4.1 Periodic self-test description... 72 3.8.4.2 Alarm monitoring during the periodic self-test ... 73 3.8.4.3 Periodic sound check ... 73 4

Operating the Prismaflex® system ... 75 4.1

About the chapter... 77

4.2 System overview ... 77 4.2.1 Interactive display... 77 4.2.2 Definitions... 77 4.2.2.1 Treatment ... 77 4.2.2.2 Treatment time... 78 4.2.2.3 Filter time... 78 4.2.2.4 Number of used sets ... 78 4.2.3 User-controllable settings ... 78 4.2.3.1 Default values... 78 4.2.3.2 Current values ... 78 4.2.3.3 Safety relevant settings ... 78 4.2.4 Prescription settings ... 79 4.2.4.1 About prescription settings ... 79 4.2.4.2 Adjusting the prescription settings... 79 4.2.4.3 Viewing the prescription settings during treatment... 80

G5036007 Revision 04.2015 Program version 8.XX

4.2.5 Status screen... 80 4.2.6 History data ... 81 4.2.6.1 Accessing history data... 81 4.2.6.2 Patient fluid removal / patient plasma loss ... 82 4.2.6.3 Doses and solutions ... 82 4.2.6.4 Pressures ... 83 4.2.6.5 Events... 83 4.2.6.6 History data after a completed treatment ... 84 4.2.6.7 History data during a power loss ... 84 4.2.6.8 Saving the history data ... 85 4.3 Therapy operation ... 85 4.3.1 Moving the Prismaflex® control unit ... 85 4.3.2 Control and navigation... 85 4.3.3 Screen layout... 85 4.3.4 Startup ... 86 4.3.5 Restart and query screen ... 87 4.3.6 Operating modes ... 87 4.3.6.1 Operating modes overview... 87 4.3.6.2 Setup mode ... 87 4.3.6.3 Operating screens in setup mode... 90 4.3.6.4 Standby mode ... 91 4.3.6.5 Operating screens in standby mode... 91 4.3.6.6 Run mode ... 92 4.3.6.7 Operating screens in run mode ... 92 4.3.6.8 End mode ... 93 4.3.6.8.1 End mode overview ... 93 4.3.6.8.2 Change set and end treatment procedures ...94 4.3.6.8.3 Change set and end treatment screens in end mode...95 4.3.6.9 Recirculation in end mode ... 95 4.3.6.9.1 About recirculation in end mode ... 95 4.3.6.9.2 Saline recirculation procedure ... 96 4.3.6.9.3 Saline recirculation screens from stop to patient connection ...97 4.3.6.9.4 Blood recirculation procedure... 98 4.3.6.9.5 Blood recirculation screens in end mode...99 4.3.7 Custom mode ... 99 4.3.8 Screens in custom mode ... 100 4.3.9 User-controllable settings ... 100 4.3.10 Change bags ... 101 4.3.10.1 Change bags function overview ... 101 4.3.10.2 Prismaflex® control unit actions ... 101 4.3.10.3 Modifying the allowed bag volume during treatment in variable empty bag mode ... 101 4.3.10.4 Changing a bag during treatment ... 101 4.3.11 Initiation of PBP flow ... 102 4.3.12 Change syringe procedures ... 102 4.3.12.1 Syringe usage... 102 4.3.12.2 Syringe installation ... 102 4.3.12.3 Syringe change... 103

G5036007 Revision 04.2015 Program version 8.XX

4.3.13 Deaeration chamber ... 104 4.3.13.1 Fluid level management ... 104 4.3.13.2 Foam management ... 104 5

Continuous renal replacement therapies (CRRT) ... 105 5.1 General warnings and cautions ... 107 5.1.1 Warnings... 107 5.1.2 Cautions ... 107 5.2 Therapy description ... 108 5.2.1 Mechanisms of CRRT ... 108 5.2.2 CRRT modes... 108 5.2.2.1 Available CRRT modes ... 108 5.2.2.2 SCUF (slow continuous ultrafiltration) ... 110 5.2.2.3 CVVH pre+post filter (continuous veno-venous hemofiltration) ... 111 5.2.2.4 CVVHD (continuous veno-venous hemodialysis) ... 112 5.2.2.5 CVVHDF (continuous veno-venous hemodiafiltration) ... 113 5.2.3 Available anticoagulation methods in CRRT ... 113 5.2.4 CRRT disposable set... 113 5.3 Specific functions in CRRT ... 116 5.3.1 Patient fluid removal rate ... 116 5.3.2 Protecting from fluid imbalance ... 116 5.3.2.1 Unintended patient fluid loss or gain ... 116 5.3.2.2 Setting the Unintended Patient Fluid Loss/Gain Limit ... 117 5.3.2.3 Loss or Gain Limit reached alarm ... 117 5.3.3 Pressure management ... 117 5.3.3.1 Software-calculated pressures ... 117 5.3.3.2 Transmembrane pressure (TMP) ... 118 5.4 Therapy operation in CRRT ... 118 5.4.1 CRRT treatment settings ... 118 5.4.2 Prescription settings ... 118 5.4.2.1 About prescription settings ... 118 5.4.2.2 Replacement solution delivery options ... 119 5.4.2.3 Total predilution ... 120 5.4.2.4 CRRT prescription indicators... 120 5.4.2.4.1 About formulas ... 120 5.4.2.4.2 Filtration fraction ... 121 5.4.2.4.3 Doses ... 121 5.4.3 Patient fluid removal management ... 121 5.4.3.1 Calculating the desired patient fluid removal rate... 121 5.4.3.2 Adjusting the patient fluid removal rate ... 122 5.4.3.3 Measuring patient fluid removed ... 122 5.4.3.4 Viewing patient fluid removed... 122 5.4.4 Viewing treatment data... 122 5.4.5 Time to change set ... 123 5.5

CRRT with HF20 disposable set... 123

G5036007 Revision 04.2015 Program version 8.XX

5.6 CRRT with septeX™ disposable set ... 124 5.6.1 Therapy information... 124 5.6.2 CRRT septeX therapy operation ... 124 5.6.3 Flow rate settings ... 124 5.6.4 Anticoagulation settings... 124 5.7 CRRT with X-MARS™ disposable set... 125 5.7.1 Description of CRRT MARS® Therapy ... 125 5.7.2 CRRT MARS® flowchart ... 125 5.7.3 X-MARS™ disposable set ... 126 5.7.4 CRRT MARS® therapy operation... 128 5.7.4.1 About CRRT MARS® therapy operation ... 128 5.7.4.2 Setup and priming ... 128 5.7.4.3 Run mode ... 130 5.7.4.3.1 Operating screens ... 130 5.7.4.3.2 Pressure management ... 130 5.7.4.3.3 Blood leak monitoring ... 130 5.7.4.4 End mode ... 130 5.8 CRRT with PrismaLung™ disposable kit ... 130 5.8.1 Warnings... 130 5.8.2 Cautions ... 131 5.8.3 PrismaLung™ disposable kit ... 131 5.8.4 Setup and operation ... 131 6

Therapeutic plasma exchange (TPE)... 133 6.1 General warnings and cautions ... 134 6.1.1 Warnings... 134 6.1.2 Cautions ... 134 6.2 Therapy description ... 135 6.2.1 Mechanism of TPE ... 135 6.2.2 TPE flowchart ... 136 6.2.3 TPE and anticoagulation methods ... 136 6.2.4 TPE disposable set... 136 6.2.5 TPE disposable set components ... 137 6.3 Specific functions in TPE ... 138 6.3.1 Bag management ... 138 6.3.2 Patient plasma loss ... 138 6.3.3 Protecting from fluid imbalance ... 138 6.3.3.1 Protecting the patient from plasma imbalance ... 138 6.3.3.2 Flow problem alarms in TPE ... 139 6.3.3.3 Protecting from excessive fluid input ... 139 6.3.4 Pressure management ... 139 6.3.4.1 Software-calculated pressures ... 139 6.3.4.2 Access transmembrane pressure (TMPa)... 140 6.3.5 Start-up phase ... 140 6.3.6 TPE prescription delivered ... 140 6.3.7 End treatment ... 140

G5036007 Revision 04.2015 Program version 8.XX

6.4 Therapy operation in TPE ... 141 6.4.1 TPE prescription and flow rates... 141 6.4.1.1 About TPE prescription and flow rates ... 141 6.4.1.2 Adjusting the TPE prescription and flow rates ... 141 6.4.1.3 Considerations when using PBP solution ... 141 6.4.1.4 Patient plasma loss rate ... 141 6.4.1.5 Software calculations of target patient plasma loss ... 141 6.4.1.6 Setting the Pt plasma loss rate to achieve prescribed target loss ... 142 6.4.1.7 Formulas used in TPE ... 142 6.4.2 Plasma balance ... 143 6.4.2.1 Patient plasma loss ... 143 6.4.2.2 Measuring patient plasma loss ... 143 6.4.2.3 Viewing Patient Plasma Loss ... 143 6.4.3 Viewing treatment data... 144 6.4.3.1 Information included in treatment data ... 144 6.4.4 Replacement bag handling ... 144 6.4.4.1 Bag or container volume... 144 6.4.4.2 Using multiple bags or containers in parallel ... 144 6.4.4.3 Handling empty bag/container alarm ... 145 7

Hemopurification (HP)... 147 7.1 General warnings and cautions ... 148 7.1.1 Warnings... 148 7.1.2 Cautions ... 148 7.2 Therapy description ... 148 7.2.1 Mechanism of HP ... 148 7.2.2 HP flowchart ... 149 7.2.3 Available anticoagulation methods in HP ... 149 7.2.4 HP-X hemopurification set ... 149 7.3 Specific functions in HP ... 150 7.3.1 User-controllable settings ... 150 7.3.2 User-defined HP devices... 151 7.3.3 Bag management ... 151 7.3.4 Fluid balance and PBP solutions... 151 7.3.4.1 Fluid input ... 151 7.3.4.2 Flow problem alarm ... 151 7.3.4.3 Unresolved flow problems alarm ... 151 7.3.4.4 Protecting from excessive fluid input ... 151 7.3.5 Pressure management ... 152 7.4 Therapy operation in HP ... 152 7.4.1 Custom mode ... 152 7.4.2 Setup mode ... 152 7.4.3 Run mode ... 152 7.4.4 End treatment ... 152

G5036007 Revision 04.2015 Program version 8.XX

7.5 HP with hemoperfusion cartridges ... 153 7.5.1 Adsorba® cartridge... 153 7.5.2 Other cartridges... 153 7.6 HP with Hemopurification Cartridges... 154 7.6.1 PrismaLung™ disposable kit ... 154 7.6.2 Setup and operation ... 154 8

Anticoagulation methods ... 157 8.1 General warnings and cautions ... 158 8.1.1 Warnings... 158 8.1.2 Cautions ... 158 8.2 Prismaflex® anticoagulation methods ... 158 8.2.1 Anticoagulation methods overview ... 158 8.2.2 Configuration of anticoagulation methods ... 159 8.2.3 Therapies and anticoagulation methods... 159 8.3 “Systemic, Prismaflex® syringe pump” method ... 160 8.3.1 Anticoagulation settings... 160 8.3.2 Adjusting the anticoagulation settings ... 160 8.3.3 Viewing the anticoagulation settings during treatment ... 160 8.3.4 Changing the syringe... 160 8.3.5 Recirculation procedures... 161 8.4

“No anticoagulation” method ... 161

8.5 Citrate – calcium anticoagulation ... 161 8.5.1 About citrate – calcium anticoagulation ... 161 8.5.2 “Citrate – calcium” anticoagulation using the Prismaflex® system ... 162 8.5.3 Citrate management ... 163 8.5.3.1 Citrate solution... 163 8.5.3.2 Citrate prescription ... 163 8.5.3.3 Viewing the anticoagulation settings during treatment ... 163 8.5.3.4 Adjusting the citrate anticoagulation settings ... 163 8.5.3.5 Citrate anticoagulation indicator ... 163 8.5.3.6 Recirculation procedures... 164 8.5.3.7 Operating limits... 164 8.5.4 Calcium management in “Citrate – calcium, external pump” method ... 165 8.5.4.1 External pump ... 165 8.5.4.2 Calcium loss indicator... 165 8.5.5 Calcium management in “Citrate – calcium, Prismaflex syringe pump” method ... 165 8.5.5.1 Syringe pump ... 165 8.5.5.2 Calcium prescription ... 166 8.5.5.3 Using calcium containing replacement solutions... 166 8.5.5.4 Replacement solution delivery options ... 167 8.5.5.5 Viewing the calcium compensation settings during treatment ...167 8.5.5.6 Adjusting the calcium compensation ... 167

G5036007 Revision 04.2015 Program version 8.XX

8.5.6 Operating limits... 167 8.5.6.1 Calcium compensation range ... 167 8.5.6.2 Flow settings and citrate dose ranges ... 168 8.5.6.3 Calcium solution concentration ... 168 8.5.7 Safety system ... 169 8.5.8 Factors to consider ... 170 8.5.8.1 Empty bag method ... 170 8.5.8.2 Calcium containing solutions ... 170 9

Blood warmers ... 171 9.1

General warnings and cautions ... 172

9.2

Blood warmers configuration... 172

9.3 Prismatherm II blood warmer ... 172 9.3.1 Description... 172 9.3.2 Prismatherm II operating temperature ... 173 9.3.3 Prismatherm II pressure drop ... 173 9.4 Sleeve blood warmers ... 174 9.4.1 Description... 174 9.5 10

NovaTherm™ heater/cooler device ... 174

Alarm system ... 177 10.1 General warnings and cautions ... 178 10.2 About the chapter... 178 10.3 Alarm management system ... 178 10.4 Warning alarms... 178 10.4.1 Occurrence of warning alarms... 178 10.4.2 Control unit actions during warning alarms ... 178 10.4.3 Operator response to warning alarms ... 179 10.4.4 Overriding warning alarms... 179 10.5 Malfunction alarms... 179 10.5.1 Occurrence of malfunction alarms... 179 10.5.2 Control unit actions during malfunction alarms... 179 10.5.3 Operator response to malfunction alarms ... 180 10.5.4 Overriding malfunction alarms... 180 10.6 Caution alarms... 180 10.6.1 Occurrence of caution alarms... 180 10.6.2 Control unit actions during caution alarms ... 181 10.6.3 Operator response to caution alarms ... 181 10.7 Advisory alarms... 181 10.7.1 Occurrence of advisory alarms... 181 10.7.2 Control unit actions during advisory alarms... 181 10.7.3 Operator response to advisory alarms ... 181 10.7.4 Overriding advisory alarms... 182

G5036007 Revision 04.2015 Program version 8.XX

10.8 Alarm priorities ... 182 10.8.1 About alarm priorities... 182 10.8.2 Alarm priority list ... 182 11

Troubleshooting ... 187 11.1 Warning alarms... 188 11.2 Warning alarm footnotes ... 206 11.3 Caution alarms... 207 11.4 Caution alarm footnotes ... 214 11.5 Advisory alarms... 215 11.6 Advisory alarm footnotes ... 229 11.7 Malfunction alarms... 230 11.8 Malfunction alarm footnotes ... 248 11.9 Miscellaneous ... 249 11.10 Miscellaneous footnotes... 252 11.11 Power failure ... 253 11.12 Manual termination of treatment... 254 11.12.1 Reason for manual termination ... 254 11.12.2 Manual termination with blood return ... 254 11.12.3 Manual termination without blood return ... 256 11.13 Leakage in pressure pods or wet fluid barrier... 258 11.14 Air removal procedures ... 259 11.14.1 Deaeration chamber ... 259 11.14.2 Air in blood alarm – manual air removal ... 259 11.15 Blood leak detector normalization... 260 11.16 Cardiac monitor procedures ... 261

12

Maintenance... 262 12.1 Service... 263 12.2 Hygiene and maintenance ... 263 12.2.1 Routine cleaning... 263 12.2.2 Cleaning the blood leak detector ... 263 12.2.3 Cleaning the touch screen ... 263 12.3 Technical preventive maintenance ... 264 12.4 Periodic safety inspection ... 265

13

Specifications ... 266 13.1 Performance... 268 13.1.1 Flow rates and accuracy... 268 13.1.1.1 Therapy/set combination ... 268 13.1.1.2 Blood flow rate ... 268

G5036007 Revision 04.2015 Program version 8.XX

13.1.1.3 13.1.1.4 13.1.1.5 13.1.1.6 13.1.1.7

Automatic blood return volume ... 268 Replacement solution/fluid flow rate ... 268 Dialysate flow rate ... 269 PBP solution rate ... 269 Patient fluid removal performance / patient plasma loss performance ... 269 13.1.1.8 Effluent flow rate ... 270 13.1.2 Syringe settings ... 270 13.1.2.1 Systemic, Prismaflex syringe pump anticoagulation method ...270 13.1.2.2 Citrate – calcium, Prismaflex syringe pump anticoagulation method ... 271 13.1.2.3 Supported syringe sizes and types... 271 13.1.3 TPE settings ... 272 13.1.4 Pressure sensor range, accuracy and alarm limits ... 272 13.1.4.1 Access ... 272 13.1.4.2 Return... 273 13.1.4.3 Filter... 273 13.1.4.4 Trans Membrane Pressure (TMP/ TMPa) ... 275 13.1.4.5 Effluent ... 276 13.1.5 Patient safety... 276 13.1.5.1 Air bubble detector ... 276 13.1.5.2 Blood leak detector ... 276 13.1.5.3 Fluid leak detector ... 276 13.2 Alarm signals ... 276 13.2.1 Standard ... 276 13.2.2 Audible... 276 13.2.2.1 Sound pressure levels ... 276 13.2.2.2 Characteristics... 277 13.2.3 Visual... 277 13.3 Information signals ... 277 13.3.1 Standards ... 277 13.3.2 Characteristics... 277 13.4 Physical data... 277 13.4.1 Weight and dimensions ... 277 13.4.2 Scales characteristics... 278 13.4.2.1 Scale weight range ... 278 13.4.2.2 Scale accuracy ... 278 13.4.3 Power ... 278 13.4.3.1 Line power ... 278 13.4.3.2 Battery backup... 278 13.4.4 External communication ... 278 13.5 Environmental data ... 279 13.5.1 Operation... 279 13.5.2 Transportation and storage ... 279 13.5.3 Noise level ... 279 13.5.4 Vibration levels ... 279 13.5.5 Fluid spillage... 279

G5036007 Revision 04.2015 Program version 8.XX

13.5.6 13.5.7

Cleanability ... 280 Electromagnetic emissions and immunity ... 280

13.6 Electrical safety ... 283 13.6.1 Classification ... 283 13.6.2 AC leakage current... 284 13.6.3 Defibrillation-proof applied part... 284 13.6.4 Radio frequency interference ... 284 13.6.5 Electromagnetic compatibility ... 284 13.6.6 Potential equalization ... 284 13.6.7 Continuous operation ... 284 13.7 Conformity to international rules... 284 13.8 Medical device classification ... 285 14

Prismaflex® Disposable Sets ... 286 14.1 Minimum and maximum flow rates... 287 14.2 CRRT disposable sets... 287 14.2.1 Low flow sets ... 287 14.2.1.1 Priming parameters and blood flow rates ... 287 14.2.1.2 Patient fluid removal and patient fluid loss/gain limit ... 287 14.2.1.3 Solution flow rates ... 287 14.2.1.4 Return blood and recirculation flow rates ... 287 14.2.2 High flow sets ... 288 14.2.2.1 Priming parameters and blood flow rates ... 288 14.2.2.2 Patient fluid removal and patient fluid loss/gain limit ... 288 14.2.2.3 Solution flow rates ... 288 14.2.2.4 Return blood and recirculation flow rates ... 288 14.2.3 Other sets ... 289 14.2.3.1 Priming parameters and blood flow rates ... 289 14.2.3.2 Patient fluid removal and patient fluid loss/gain limit ... 289 14.2.3.3 Solution flow rates ... 289 14.2.3.4 Return blood and recirculation flow rates ... 289 14.3 TPE disposable sets ... 290 14.3.1 Low flow sets ... 290 14.3.1.1 Priming parameters and blood flow rates ... 290 14.3.1.2 Return blood and recirculation flow rates ... 290 14.3.2 High flow sets ... 290 14.3.2.1 Priming parameters and blood flow rates ... 290 14.3.2.2 Return blood and recirculation flow rates ... 290 14.4 HP kits ... 291 14.4.1 Priming parameters and blood flow rates ... 291 14.4.2 Return blood and recirculation flow rates ... 291

15

User-controllable settings ... 292 15.1 General settings ... 293 15.2 CRRT specific settings ... 294

G5036007 Revision 04.2015 Program version 8.XX

15.3 TPE specific settings ... 296 15.4 HP specific settings ... 297 15.5 User defined HP cartridges ... 298 15.6 Anticoagulation related settings... 299 15.6.1 Systemic anticoagulation method... 299 15.6.2 Citrate – calcium method... 300

G5036007 Revision 04.2015 Program version 8.XX

This page is intentionally left blank.

1

Before you get started 1.1 General information ... 16 1.1.1 Intended use... 16 1.1.2 Contraindications... 16 1.1.3 Keywords used in this manual... 16 1.2 Where to find information... 17 1.2.1 Operator's manual ... 17 1.2.2 Online instructions ... 18 1.2.3 Instructions for use of Prismaflex® disposable sets ... 18 1.3

Therapies... 18

1.4

Anticoagulation methods ... 19

1.5

Responsibility and disclaimer... 19

1.6

Safety definitions... 20

1.7 General warnings and cautions ... 20 1.7.1 Warnings... 20 1.7.2 Cautions ... 26 1.8 Symbols... 28 1.8.1 About symbols ... 28 1.8.2 Electrical safety ... 28 1.8.3 Instructions and warnings... 28 1.8.4 Information... 29 1.8.5 Communication... 29 1.8.6 Environmental... 29 1.8.7 Transportation and storage ... 30 1.8.8 Solutions... 30 1.8.9 Certification marks... 30 1.9

Installation, service and transport ... 31

1.10 Disposal ... 31 1.10.1 Disposal of packaging material... 31 1.10.2 Disposal of discarded equipment ... 31 1.10.3 Hazardous substances ... 32 1.10.4 Disposal of waste batteries and accumulators ... 32

G5036007 Revision 04.2015 Program version 8.XX

Prismaflex® Operator's Manual - Before you get started

15

1.1

General information

1.1.1

Intended use The Prismaflex control unit is intended for: ● Continuous Renal Replacement Therapy for patients with acute renal failure and/or fluid overload. ● Therapeutic Plasma Exchange Therapy for patients with diseases where removal of plasma components is indicated. ● Hemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated. ● Hemopurification for patients with conditions where extracorporeal elimination of carbon dioxide is indicated. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

1.1.2

Contraindications There are no known contraindications to Continuous Renal Replacement Therapies. There are no known contraindications to Therapeutic Plasma Exchange. There are no known contraindications to Hemoperfusion. There are no known contraindications to Hemopurification. For contraindications that may apply to the disposable set selected for the therapy, refer to the Instructions For Use of the disposable set.

1.1.3

Keywords used in this manual Applied part Applied part is any part of the Prismaflex system that needs to physically contact the patient in normal use. Lines of the disposable set are applied parts. A general warning sign by the discharger ring guide indicates connection between the Prismaflex control unit and applied part. Authorized service technicians This term refers to Gambro trained and certified service technicians. Filter Depending on the therapy in use, Filter stands for either: ● Hemofilter/Dialyzer ● Plasmafilter ● Hemopurification cartridge Manual The term Manual refers to this manual unless specified differently. Operator In this manual, Operator designates appropriately trained and qualified clinical staff who is in charge of the Prismaflex control unit. The operator sets the prescribed values in accordance with the prescribed treatment, responds to alarms, troubleshoots the Prismaflex control unit, handles the bags, etc. Once

16

Prismaflex® Operator's Manual - Before you get started

G5036007 Revision 04.2015 Program version 8.XX

the training material is read through and understood, the operator is approved to operate the Prismaflex control unit. The operator works within one meter from the front of the Prismaflex control unit. Responsible Organization In this manual, Responsible Organization means a function or a person who can identify, analyze, and control potential risks that could occur, for example, when connecting the Prismaflex control unit to other equipment or when making changes to the equipment connected to the Prismaflex control unit. Screens The Prismaflex control unit displays different screens during operation. Whenever a screen is referred to in this manual, it is identified by its title, e.g. Enter Flow Settings screen or Status screen. Softkeys Whenever a Softkey on the Prismaflex screen is referred to in this manual, it is written in capital bold letters, e.g. NEW PATIENT or CHANGE BAG. Total weight Total weight is weight of the Prismaflex control unit including maximum load of accessories, disposables and solutions. Training Material The operator's manual is the primary training material for staff who is to operate the Prismaflex system. Transport position Transport position requires that the operator is at the rear of the Prismaflex control unit, moving the machine in a forward direction by the rear handles. See Section 4.3.1 “Moving the Prismaflex® control unit” on page 85.

1.2

Where to find information

1.2.1

Operator's manual This manual provides operating, maintenance, and troubleshooting instructions, as well as general information. See Section 2 “Description of the Prismaflex® system” on page 35 for information about the Prismaflex control unit and system components. See Section 3 “General Prismaflex® functions” on page 59 for description of the principles of operation of the system, notably about fluid and pressure management. See Section 4 “Operating the Prismaflex® system” on page 75 for explanation of the system interface, an overview of a treatment sequence and the routine handling steps. Specific therapy information is provided for: ● CRRT in Section 5 “Continuous renal replacement therapies (CRRT)” on page 105 ● TPE in Section 6 “Therapeutic plasma exchange (TPE)” on page 133 ● HP in Section 7 “Hemopurification (HP)” on page 147 ● Anticoagulation in Section 8 “Anticoagulation methods” on page 157

G5036007 Revision 04.2015 Program version 8.XX

Prismaflex® Operator's Manual - Before you get started

17

1.2.2

Online instructions Detailed operating instructions are incorporated in the software of the Prismaflex control unit. The instructions are available online, through the interactive display. Instructions include the following screens: ● Operating screens (step-by-step instructions that the operator follows each time in setting up, administering treatment, verifying settings, and ending patient treatments). ● Alarm screens (instructions when an alarm situation occurs). ● Help screens (additional information about an operating or alarm screen).

1.2.3

Instructions for use of Prismaflex® disposable sets Instructions for use are provided with Prismaflex disposable sets, and provide operating flow rates, filter pressures, priming requirements, performance data, and other information for use of the set with the Prismaflex system.

1.3

Therapies The Prismaflex control unit pumps blood from the patient, through the filter in a Prismaflex disposable set, and back to the patient’s venous circulation. As the blood passes through the filter, the desired treatment processes take place. Depending on the therapy in use, these processes can include fluid removal and/or solute clearance. For instructions about the different therapies, see each respective therapy chapter. During the setup procedure, the operator selects the therapy desired. The Prismaflex system provides: CRRT – Continuous Renal Replacement Therapies ● SCUF – Slow Continuous Ultrafiltration ● CVVH – Continuous Veno-venous Hemofiltration ● CVVHD – Continuous Veno-venous Hemodialysis ● CVVHDF – Continuous Veno-venous Hemodiafiltration CRRT septeX – Continuous Renal Replacement Therapies with high cut-off membrane ● CVVHD – Continuous Veno-venous Hemodialysis ● CVVHD+post – Continuous Veno-venous Hemodialysis + post infusion CRRT MARS® – Continuous Renal Replacement Therapies supporting Molecular Adsorbents Recirculation System ● CVVHD – Continuous Veno-venous Hemodialysis ● CVVHDF – Continuous Veno-venous Hemodiafiltration TPE – Therapeutic Plasma Exchange HP – Hemopurification NOTE! All therapies beside CRRT require a service configuration. Contact your local representative for additional information.

18

Prismaflex® Operator's Manual - Before you get started

G5036007 Revision 04.2015 Program version 8.XX