Fresenius Medical
5008 Hemodialysis System Instructions for Use Part no M56 043 1 Sw ver 4.57 Edition 10B-2015
Instructions for Use
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5008 Hemodialysis System Instructions for Use Software version: 4.57 Edition: 10B-2015 Part no.: M56 043 1 0123
Table of contents 1
Index
2
Important information
3
2.1
How to use the Instructions for Use ... 2-1
2.2
Significance of warnings ... 2-2
2.3
Significance of notes ... 2-2
2.4
Significance of tips... 2-2
2.5
Brief description ... 2-3
2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.7 2.6.8 2.6.9
Intended use ... 2-4 Intended purpose... 2-4 Specified application... 2-4 Side effects... 2-4 Contraindications... 2-4 Restrictions... 2-4 Interaction with other systems ... 2-5 Target group ... 2-5 Repair, maintenance, transport ... 2-5 Expected service life... 2-5
2.7
Duties of the responsible organization ... 2-6
2.8
Operator responsibility ... 2-6
2.9
Disclaimer of liability... 2-7
2.10
Technical documentation ... 2-7
2.11 2.11.1 2.11.2 2.11.3 2.11.4 2.11.5
Warnings ... 2-7 Warnings, hygiene... 2-7 Warnings, therapy ... 2-8 Warnings, system-specific... 2-10 Warnings relating to electricity... 2-13 Warnings, consumables and accessories ... 2-15
2.12
Additional optional equipment supplied by Fresenius Medical Care... 2-16
2.13
Addresses ... 2-17
Design 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5
Views ... 3-1 Front view ... 3-1 Rear view... 3-2 Left side view... 3-3 Right side view ... 3-4 Monitor front ... 3-6
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4
3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 3.1.11
Monitor rear ... 3-7 Extracorporeal Blood Circuit Module ... 3-8 Extracorporeal Blood Circuit Module with additional functions ... 3-12 Hydraulics ... 3-14 Hydraulics connectors ... 3-15 External connection options / connection to power supply ... 3-16
3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5
User interface... 3-17 After switching power on to the device ... 3-17 Overview (screen)... 3-18 General operation philosophy... 3-20 Examples for data entry (treatment data) ... 3-23 Screen saver... 3-25
Operation 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6
4.1.7 4.1.8 4.1.9 4.1.10 4.1.11 4.2 4.2.1 4.2.2
4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5
iv
Preparation... 4-1 Screens... 4-1 Switching on the hemodialysis system ... 4-5 Observe the following when using consumables... 4-6 Selecting the concentrate supply... 4-7 Observe the following before and during treatment... 4-10 Inserting and priming the extracorporeal blood circuit ... 4-15 4.1.6.1 Inserting and priming the extracorporeal blood circuit using ONLINEplus™ ... 4-16 4.1.6.2 Inserting and priming the extracorporeal blood circuit using a rinse solution bag ... 4-22 4.1.6.3 SN - Inserting and priming the extracorporeal blood circuit using ONLINEplus™ ... 4-26 4.1.6.4 SN - Inserting and priming the extracorporeal blood circuit using a rinse solution bag.. 431 Checking / setting the dialysate parameters... 4-35 Checking / setting the UF parameters ... 4-35 Checking / setting the sodium and UF profiles ... 4-36 Checking / setting the heparin pump parameters ... 4-38 Checking / setting the Single-Needle parameters ... 4-38 Treatment ... 4-39 TREATMENT menu... 4-39 Connecting the patient... 4-40 4.2.2.1 Connecting the patient – Double-Needle treatment using ONLINEplus™ ... 4-41 4.2.2.2 Connecting the patient – Double-Needle treatment with rinse solution bag... 4-44 4.2.2.3 Connecting the patient – Single-Needle treatment using ONLINEplus™ ... 4-45 4.2.2.4 Connecting the patient – Single-Needle treatment with rinse solution bag ... 4-50 Changing the dialysate parameters ... 4-53 Changing the UF parameters ... 4-53 Sodium and UF profiles ... 4-53 Changing the heparin pump parameters ... 4-54 Single-Needle ... 4-54 Reinfusion ... 4-57 REINFUSION menu... 4-57 Disconnect the patient ... 4-58 4.3.2.1 Disconnecting the patient – Double-Needle treatment using ONLINEplus™... 4-59 4.3.2.2 Disconnecting the patient – Double-Needle treatment using a rinse solution bag ... 4-61 Emptying the dialyzer ... 4-63 Emptying the bibag® ... 4-63 Removing the tubing system ... 4-63
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4.4 4.4.1
4.4.2 4.4.3
4.4.4
4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.4.10 4.4.11 4.4.12
4.4.13 4.4.14 4.4.15 4.4.16 4.4.17
4.4.18
4.4.19
Other functions... 4-65 SYSTEM menu settings ... 4-65 4.4.1.1 SYSTEM menu ... 4-65 4.4.1.2 Selecting the SYSTEM menu... 4-65 4.4.1.3 Adjusting the settings in the SYSTEM menu... 4-65 4.4.1.4 SYSTEM menu overview ... 4-66 Service... 4-67 User setup ... 4-67 4.4.3.1 Selecting the User setup ... 4-67 4.4.3.2 User setup (screen overview)... 4-67 4.4.3.3 Adjusting the settings in the User setup ... 4-67 4.4.3.4 User setup overview... 4-68 Applications ... 4-102 4.4.4.1 Selecting applications ... 4-102 4.4.4.2 Adjusting the Applications settings... 4-102 4.4.4.3 Applications overview... 4-102 PatientCard... 4-105 4.4.5.1 Uploading the treatment parameters... 4-105 4.4.5.2 Saving the treatment parameters ... 4-105 Emergency button ... 4-106 Emptying / changing the bibag® ... 4-106 Changing the DIASAFE® plus ... 4-107 Cleaning the dialysis fluid particle filter... 4-109 Performing a fluid sampling ... 4-109 Removing lines during preparation... 4-109 Removing lines during treatment... 4-109 4.4.12.1 Changing the arterial line ... 4-109 4.4.12.2 Changing the venous line... 4-110 4.4.12.3 Removing the SafeLine™ ... 4-110 4.4.12.4 Inserting / retrofitting the SafeLine™... 4-111 4.4.12.5 Removing all lines ... 4-111 Circulation... 4-111 Administering infusion solutions ... 4-112 Setting the level in the venous bubble catcher ... 4-113 Single-Needle Click-Clack ... 4-114 OCM (Online Clearance Monitoring) ... 4-117 4.4.17.1 Observe before using the device... 4-117 4.4.17.2 Description ... 4-117 4.4.17.3 Menu overview ... 4-119 4.4.17.4 OCM chart ... 4-120 4.4.17.5 Checking / setting the OCM parameters ... 4-120 4.4.17.6 Stability criteria ... 4-121 4.4.17.7 Starting the OCM ... 4-121 4.4.17.8 Stopping the OCM... 4-121 ONLINEplus™ ... 4-123 4.4.18.1 Observe before using the device... 4-123 4.4.18.2 Description ... 4-123 4.4.18.3 Menu overview ... 4-124 4.4.18.4 Preparation, treatment, reinfusion ... 4-125 4.4.18.5 Description AutoSub plus ... 4-125 Network ... 4-127 4.4.19.1 Observe before using the device... 4-127 4.4.19.2 DataXchange Panel ... 4-127
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5
6
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Alarm processing 5.1
General alarm processing information... 5-1
5.2
Operating status indicator ... 5-1
5.3
Audible alarms ... 5-2
5.4
Messages (alarm / warning / info) ... 5-2
5.5
Air detected below the venous bubble catcher ... 5-5
5.6
Micro bubbles detected below the venous bubble catcher... 5-9
5.7
Monitoring of alarm limits (arterial / venous)... 5-15
5.8
Lower arterial pressure alarm in case of Double-Needle treatment ... 5-15
5.9 5.9.1 5.9.2 5.9.3
BLK (Bloodline kinking and filter clotting monitoring) ... 5-16 Observe before using the device ... 5-16 Description... 5-16 Treatment ... 5-16
5.10 5.10.1 5.10.2 5.10.3 5.10.4
WET (Wet Transducer Protector) ... 5-16 Observe before using the device ... 5-16 Description... 5-17 Treatment ... 5-17 Alarm processing ... 5-17
5.11 5.11.1 5.11.2 5.11.3
VAM (Venous Access Monitor)... 5-18 Observe before using the device ... 5-18 Description... 5-18 Alarm processing ... 5-19
5.12
Blood leak... 5-19
5.13
Conductivity ... 5-20
5.14
Power failure (mains failure)... 5-20
5.15
Screen failure ... 5-22
5.16
Manually opening the arterial pressure measurement unit... 5-24
Cleaning / disinfection 6.1
Observe before using the device ... 6-1
6.2
Basic requirements ... 6-3
6.3
Connecting the disinfectant canister... 6-4
6.4
Starting a cleaning program ... 6-6
6.5
Stopping a cleaning program ... 6-10
6.6
Cleaning program completed ... 6-11
6.7 6.7.1 6.7.2
Check for residual disinfectant ... 6-12 Automatic check for residual disinfectant ... 6-13 Manual check for residual disinfectant... 6-13
6.8 6.8.1 6.8.2
Endless rinse ... 6-15 Observe before using the device ... 6-15 Central disinfection ... 6-15
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8
9
6.8.3
Central free rinse ... 6-17
6.9
Surface cleaning / surface disinfection... 6-18
6.10
Switching off the hemodialysis system ... 6-20
6.11
Filter change ... 6-20
Functional description 7.1
Extracorporeal blood circuit... 7-2
7.2
Extracorporeal blood circuit with additional functions ... 7-4
7.3
Hydraulics ... 7-8
7.4
Description bibag® ... 7-10
7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5
Tubing systems (description) ... 7-12 Tubing system ONLINEplus™ ... 7-12 Tubing system with rinse solution bag... 7-14 Tubing system ONLINEplus™ Single-Needle ... 7-16 Tubing system, Single-Needle with rinse solution bag ... 7-18 MIXED HDF tubing system... 7-20
7.6
Dialyzer connectors ... 7-22
Consumables, accessories, additional equipment 8.1
Observe in Chapter Consumables, accessories, additional equipment ... 8-1
8.2
Dialyzers... 8-1
8.3
Tubing systems ... 8-2
8.4
Disposable syringes... 8-2
8.5
Hemodialysis concentrates ... 8-2
8.6
Dialysis fluid filter DIASAFE® plus ... 8-2
8.7
Surface disinfection / surface cleaning... 8-3
8.8
Disinfectants for the hydraulics ... 8-3
8.9
Disinfectant indicators... 8-3
Installation 9.1 9.1.1 9.1.2 9.1.3 9.1.4 9.1.5 9.1.6
Initial start-up... 9-1 Observe before initial start-up ... 9-1 Electrical installation ... 9-1 Dialysis water ... 9-3 Dialysis fluid... 9-4 Concentrates ... 9-5 Performing the initial start-up... 9-5
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10 Transport / storage 10.1
Relocation ... 10-1
10.2
Transport ... 10-2
10.3 10.3.1
Storage ... 10-3 Storage conditions ... 10-3
10.4
Environmental compatibility / disposal ... 10-3
11 Technical Safety Checks / maintenance 11.1
Important information regarding the procedure... 11-1
12 Specifications
viii
12.1
Dimensions and weight... 12-1
12.2
Identification label (device identification) ... 12-1
12.3
Electrical safety ... 12-2
12.4
Electrical supply ... 12-2
12.5
Fuses ... 12-3
12.6
Manufacturer's declaration on EMC... 12-3
12.7
Operating conditions... 12-4
12.8
Consumption data / energetic data... 12-5
12.9
Storage conditions ... 12-6
12.10
External connection options ... 12-7
12.11
Override conditions... 12-8
12.12
Operating programs ... 12-8
12.13
Dialysate circuit and safety systems ... 12-10
12.14
Extracorporeal blood circuit and safety systems... 12-13
12.15
DIASAFE® plus ... 12-15
12.16
OCM ... 12-15
12.17
ONLINEplus™ ... 12-15
12.18
Network... 12-16
12.19
Single-Needle (option)... 12-16
12.20
VenAcc (option) ... 12-16
12.21
BPM (option) ... 12-17
12.22
BTM (option)... 12-17
12.23
BVM (option) ... 12-18
12.24
MIXED HDF (option)... 12-18
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12.25
Materials used... 12-19
13 Definitions 13.1
Definitions and terms... 13-1
13.2
Abbreviations... 13-2
13.3
Symbols... 13-4
13.4
Consumables symbols ... 13-6
13.5
Bibliography... 13-8
13.6 13.6.1
Certificates ... 13-9 EC certificate ... 13-9
14 Options 14.1 14.1.1 14.1.2 14.1.3 14.1.4
Single-Needle (SN) option ... 14-1 Observe before using the device... 14-1 Description... 14-1 Menu overview ... 14-2 Preparation, treatment, reinfusion ... 14-3
14.2 14.2.1 14.2.2 14.2.3
VenAcc Option (Venous Access)... 14-5 Observe before using the device... 14-5 Description... 14-6 Design ... 14-6 14.2.3.1 VenAcc ... 14-6 14.2.3.2 Monitoring unit (front view) ... 14-7 14.2.3.3 Monitoring unit (rear view)... 14-7 Menu overview ... 14-8 Operation... 14-9 14.2.5.1 Connecting the VenAcc... 14-9 14.2.5.2 Logging in the monitoring unit ... 14-10 14.2.5.3 Monitoring unit connection test... 14-10 14.2.5.4 Logging out the monitoring unit ... 14-11 14.2.5.5 Removing the VenAcc... 14-11 Alarm processing... 14-12 Changing the battery ... 14-12
14.2.4 14.2.5
14.2.6 14.2.7 14.3 14.3.1 14.3.2 14.3.3 14.3.4 14.3.5
14.3.6 14.3.7 14.3.8
Option BPM (Blood Pressure Monitoring) ... 14-15 Observe before using the device... 14-15 Description... 14-16 Blood pressure cuffs / pressure tubing ... 14-17 Menu overview ... 14-18 Charts / BPM history... 14-20 14.3.5.1 BPM, chart (SYS / DIA / PULSE) ... 14-20 14.3.5.2 BPM (MAP), chart (MAP/PULSE) ... 14-21 14.3.5.3 BPM history ... 14-21 Attaching the blood pressure cuff ... 14-22 Checking / setting the inflation pressure / warning limits... 14-22 Starting the blood pressure measurement ... 14-23 14.3.8.1 Single measurement ... 14-23
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14.3.8.2 Interval (long-term interval measurement) ... 14-23 14.3.8.3 Quick (short-term interval measurement) ... 14-24 14.3.9 Blood pressure measurement completed ... 14-25 14.3.10 Stopping the blood pressure measurement... 14-25 14.3.11 Entering BPM data manually ... 14-25 14.4 14.4.1 14.4.2 14.4.3 14.4.4
14.4.5 14.4.6 14.4.7 14.5 14.5.1 14.5.2 14.5.3 14.5.4
Option BTM (Blood Temperature Monitor)... 14-27 Observe before using the device ... 14-27 Description... 14-28 Menu overview... 14-29 Displaying charts / events... 14-31 14.4.4.1 BTM T control... 14-31 14.4.4.2 BTM rec. ... 14-32 14.4.4.3 BTM events ... 14-32 Preparation ... 14-33 Recirculation ... 14-33 Temperature control ... 14-34
14.5.5 14.5.6 14.5.7 14.5.8
Option BVM (Blood Volume Monitor) ... 14-37 Observe before using the device ... 14-37 Description... 14-38 Menu overview... 14-42 Displaying charts / events... 14-45 14.5.4.1 BVM... 14-45 14.5.4.2 BVM / BPM ... 14-46 14.5.4.3 BVM events ... 14-46 Preparation ... 14-47 Calibration... 14-48 Measuring the RBV (Relative Blood Volume), hemoglobin and hematocrit ... 14-48 Alarm processing ... 14-49
14.6 14.6.1 14.6.2 14.6.3 14.6.4 14.6.5 14.6.6 14.6.7
MIXED HDF option ... 14-51 Observe before using the device ... 14-51 Description... 14-52 Menu overview... 14-53 Chart ... 14-53 Preparation, treatment, reinfusion ... 14-54 Inserting the extracorporeal blood circuit... 14-55 Changing from MIXED HDF to Single-Needle... 14-58
14.7 14.7.1 14.7.2 14.7.3 14.7.4
Option HD-PAED... 14-59 Observe before using the device ... 14-59 Description... 14-60 Menu overview... 14-61 Operation ... 14-62 14.7.4.1 User setup (HD-PAED) ... 14-62 14.7.4.2 Paeddy icon... 14-63 14.7.4.3 Changing from Pediatric mode to Standard mode ... 14-64 14.7.4.4 Changing from Standard mode to Pediatric mode ... 14-64 14.7.4.5 Setting the level... 14-64
15 Appendix 15.1
x
Notes on the use of “Free software” ... 15-1
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Chapter 1: Index
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Index
A Abbreviations 13-2 Acetate dialysis 4-9
AutoFlow 12-11
BPM description 14-16
Auto-Single-Needle 12-16
BPM design 3-12
AutoSub plus 4-125
BPM operation 14-18 BPM pressure port 3-12
Additional optional equipment 2-16
B
BPM pressure tubing 14-17 BPM specifications 12-17
Air bubble detector 3-11, 12-13
Barrel holder with syringe detector 3-10
BPM User setup 4-98
Air removal 5-6
Battery 9-3, 10-3, 12-6
Bracket (heparin pump) 3-10
Alarm 5-2
bibag® 4-8, 4-60, 4-63, 7-10
Brake 3-3, 3-4
Alarm limits, monitoring (arterial / venous) 5-15
bibag® port 3-14
Brief description 2-3
bibag®, connecting 4-8
BTM 14-27
Alarm output (nurse call) 3-16, 13-5
bibag®, emptying / changing 4-106
BTM (arterial measuring head) 3-12
Alarm override 12-8
Bibliography 13-8
Alarm processing 4-83, 5-1
Bicarbonate dialysis 4-8
BTM (venous measuring head) 3-12
Anticoagulation 4-70
Bicarbonate flap 3-14
Appendix 14-1, 15-1 Applications 4-102
Bicarbonate suction tube (blue) 3-14
AquaUNO / AquaC UNO H 2-16, 3-16, 12-7, 13-5
BLK 5-16
Addresses 2-17
Bld. press. (display / button) 3-19
Arterial insertion site / sampling site 7-12, 7-14, 7-16, 7-18
BLK description 5-16 BLK operation 5-16
Arterial line, changing 4-109 Arterial measuring head (BTM) 3-12 Arterial occlusion clamp 3-8 Arterial patient line 7-12, 7-14, 7-16, 7-18 Arterial pressure 3-19 Arterial pressure dome 4-17, 4-23, 4-27, 4-32, 7-12, 7-14, 7-16, 7-18
BVM basic control 14-40
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Bubble catcher 13-1
Blood flow (display / button) 3-19
BVM description 14-38
Blood inlet of the dialyzer 7-22
BVM design 3-12
Blood leak 5-19
BVM Extracorporeal Blood Circuit 7-4, 7-5
Blood leak detector 12-10 Blood pressure 12-17 Blood pressure cuff 3-12
BVM measuring head 3-12 BVM operation 14-42 BVM specifications 12-18 BVM surface cleaning 6-19
Blood pressure measurement 14-15
BVM User setup 4-100
Blood pump 3-8, 3-10, 4-68
C
Body temperature control 12-18
Card slot 3-7
BPM 14-15
Central Delivery System (CDS) 4-9
BPM data, entering manually 14-25
Auto On 4-89
BTM surface cleaning 6-19
Blood flow 7-22
BPM blood pressure cuffs 14-17
Auto Off 6-11
BTM specifications 12-17
BVM 14-37
Blood pressure cuffs 14-17
Audible info 6-11
BTM operation 14-29
Blood alarms 7-3, 13-1
Arterial pressure measurement unit, opening manually 5-24
Audible alarm 12-14
BTM Extracorporeal Blood Circuit 7-4, 7-5
BTM User setup 4-99
Blood outlet of the dialyzer 7-22
Arterial tubing system connector 7-12, 7-14, 7-16, 7-18
BTM design 3-12
BLK User setup "Extended safety" Kinking (BLK) 4-92
Arterial pressure measurement unit 3-8, 4-11, 4-17, 4-23, 4-27, 4-32, 7-2
Arterial tubing system 7-12, 7-14, 7-16, 7-18
BTM description 14-28
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Certificates 13-9 Chart time scale 4-66
1-1
Chapter 1: Index
Check for residual disinfectant 6-12 Circulation 4-111
Dialysate inlet port 7-22
Emergency 4-92
Dialysate inlet tube 3-4, 7-22
Emergency button 3-19, 4-92, 4-106
Dialysate lines 3-4, 4-20, 4-24, 4-29, 4-33
Emergency operation 5-21, 5-22
Clamping brackets (heparin pump) 3-10
Dialysate menu 4-35, 4-37
Endless rinse 6-15
Cleaning / disinfection 6-1
Dialysate outlet port 7-22
Environmental compatibility / disposal 10-3
Cleaning program 6-6, 6-10
Dialysate outlet tube 3-4, 7-22
Equipotential bonding 3-15, 9-2
Collection bag 7-15, 7-19
Dialysate parameters 4-35, 4-53 Dialysate temperature 12-11
Expected service life 2-5
Concentrate flap 3-14
Dialysis fluid 9-4
Cleaning programs 12-9
Concentrate rack 3-3, 3-4, 4-7 Concentrate suction tube (red) 3-14
Dialysis fluid particle filter, cleaning 4-109 Dialysis water 9-3, 13-1
Concentrates 4-7, 12-11
Dialyzer 7-12, 7-14, 7-16, 7-18
Conductivity 13-1
Dialyzer connectors 7-22
Conductivity alarm 5-20
Dialyzer coupling, inlet 7-22
Connection, venous pressure line 7-13, 7-14, 7-16, 7-18
Dialyzer coupling, outlet 7-22
Connector for BIC, blue 3-15
Dialyzer holder 3-4, 3-5
Connector for CDS 1, red 3-15 Connector for CDS 2, red 3-15 Connector postdilution 7-13, 7-17 Connector pre- / postdilution (SafeLine™) 7-13, 7-17 Connector predilution 7-13, 7-17
Dialyzer couplings 3-5 Dialyzer, emptying 4-60, 4-63 Dialyzers 8-1 DIASAFE®plus 8-2, 12-15 DIASAFE®plus, changing 4-107 Dimensions 12-1 Disclaimer of liability 2-7
Connector, SN pressure line 7-17, 7-19
Disinfectant 8-3
Consumables, accessories, additional equipment 8-1
Disinfectant canister, connecting 6-4
Consumption data / energetic data 12-5
Disinfectant connector, black 3-15
Contraindications 2-4
Disinfectant connector, yellow 3-15
Cuff holder 3-12
Disinfectant indicators 8-3
Current messages 3-18
Disposal 10-3
D Data entry, examples (treatment data) 3-23
Double-Needle 4-5, 4-40, 4-41, 4-44, 4-58, 4-59, 4-61 Drain 3-15
External connection options 3-2, 3-16, 12-7 Extracorporeal Blood Circuit Module (EBM) 3-1, 3-8, 3-12, 4-16, 4-17, 4-20, 4-22, 4-24, 4-26, 4-30, 4-31, 4-34, 14-55
F Fan filter (service door) 3-2 Filter 1 – DIASAFE®plus 3-4, 7-4 Filter 2 – DIASAFE®plus 3-4, 7-4 Filter chamber 3-4 Filter change 4-107 Fixation for the plunger (heparin pump) 3-10 Flow alarm 12-12 Flow chart 7-8 Fluid sampling 4-103, 4-109 Flush 12-9 Flush drain 3-15 Food intake 14-44 Free software 2-3, 15-1 Front view 3-1 Functional description 7-1 Fuses 12-3
G General operation philosophy 3-20
DataXchange Panel 4-127
E
Grip handle (heparin pump) 3-10
Decalcification 8-3
EBC 13-3
Groove 3-8
Define options 4-86
EBM 13-3
Definitions 13-1
EcoFlow 4-35, 12-12
H
Definitions and terms 13-1
Electrical safety 12-2
Handle 5-21, 5-22
Degreasing 8-3
Electrical supply 12-2
Design 3-1
Electromagnetic compatibility (EMC) 12-3, 13-3
Handle for emergency operation 3-10
Dialysate flow 7-22, 12-11 Dialysate flow (display) 3-18
1-2
EMC 12-3, 13-3
HD-PAED 4-101, 14-59 HD-PAED description 14-60
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Chapter 1: Index
HD-PAED operation 14-61, 14-62
K
Micro bubbles 5-9
HD-PAED User setup 4-68
Kinking (BLK) 4-92
Micro bubbles removal 5-12
Hemoconcentration 13-1
Kinking / clotting 4-92, 5-16
Hemodialysis concentrates 8-2
Kt/V 4-117
Hemodialysis system, switching off 6-20
Kt/V warning 4-96
Hemodialysis system, switching on 4-5
LAN (network) 3-16, 12-16, 13-5, 14-5
Heparin (menu) 4-38
Lateral view 3-3, 3-4
Heparin line 7-13, 7-15, 7-17, 7-19
Leakage sensor, Extracorporeal Blood Circuit Module 3-8
Heparin menu 3-19 Heparin pump 3-8, 3-10, 7-2, 12-14
Leakage sensor, filter chamber 3-4
Heparin pump parameters 4-38, 4-54
Level detector 3-11, 12-13
LEDs / buttons 3-6
Heparin syringe 4-18, 4-23, 4-27, 4-32, 7-13, 7-15, 7-17, 7-19, 8-2, 14-56 Holder for SN chamber 3-12 How to use the Instructions for Use 2-1 Hydraulics 3-1, 3-2, 3-14, 3-15
Level, setting level in SN chamber 4-54
Miscellaneous 4-97 MIXED HDF 14-51 MIXED HDF design 3-13 MIXED HDF extracorporeal blood circuit 7-6 MIXED HDF operation 14-53 MIXED HDF specifications 12-18 MIXED HDF surface cleaning 6-18 MIXED HDF tubing system 7-20 MIXED HDF User setup 4-93 Monitor 3-1, 3-6, 3-7 Monitor arm 3-7
Level, setting the level in the venous bubble catcher 4-113
Mute 12-8
Line guide 3-10, 7-12, 7-14, 7-16, 7-18
N
Line holder (for transport) 3-2 Line holder for the SafeLine™ 3-9
Hydraulics connectors 3-2, 3-15
Line holders 3-8
Hydrophobic filter in the SN pressure line 7-17, 7-19
Line pulley 3-10 Line roller 3-10
Hydrophobic filter in the venous pressure line 7-12, 7-14, 7-16, 7-18
Microbiology 9-4, 9-5
MIXED HDF description 14-52
L
Heparin (display) 3-19
Micro bubbles, overriding 5-11
Lines, removing all 4-111
Network 4-127 Network (LAN) 3-16, 4-127, 12-16, 13-5 Numeric keypad 3-23
O OCM 4-117
Lines, removing during preparation 4-109
OCM description 4-117
I
Lines, removing during treatment 4-109
OCM specifications 12-15
Identification label 12-1
Loudness (audible alarm) 4-66
OCM User setup 4-96
Important information 2-1
Loudspeaker 3-7
ONLINE (bolus) 4-43, 4-48, 4-94
Info 5-2
ONLINE Priming Set 4-16
Info (button) 3-19
ONLINEplus™ 4-41, 4-58, 4-123
M
Infusion solution 4-112
Mains failure (power failure) 5-20
Infusion solutions, administering 4-112
Maintenance 2-5 Manufacturer's declaration on EMC 12-3
Initial start-up 2-17, 9-1 Installation 9-1
Materials 12-19, 12-21
Intended purpose 2-4
Materials used 12-19
Intended use 2-4 Interaction with other systems 2-5 ISO UF 13-1 ISO UF (Sequential therapy) 12-8 IV pole 3-4, 3-5
Fresenius Medical Care
OCM operation 4-119
Maximum total weight 12-1, 13-2 Menu bar 3-19 Menu panel 3-19 Menu structure, design 3-22 Messages 5-2
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ONLINEplus™ description 4-123 ONLINEplus™ design 3-8 ONLINEplus™ Extracorporeal Blood Circuit 7-4, 7-5 ONLINEplus™ operation 4-124 ONLINEplus™ specifications 12-15 ONLINEplus™ surface cleaning 6-18 ONLINEplus™ tubing system 7-12 ONLINEplus™ tubing system Single-Needle 7-16
1-3
Chapter 1: Index
Push handle 3-2
Screen failure, screen dark or display distorted 5-22
Operating mode (display) 3-18
R
Screen saver 3-25
Operating programs 12-8 Operating status indicator 3-6
Reaction ven. window alarm 4-84, 5-15
Operation 4-1
Rear view 3-2
Operator card 13-2
Recessed handles 3-7
Operator responsibility 2-6
Recirculating adapter (SafeLine™) 7-13, 7-17
ONLINEplus™ User setup 4-93 Operating conditions 12-4
Operator setup 13-2 Optical detector 3-11, 4-18, 4-23, 4-28, 4-33, 12-13, 14-56
Recirculation 14-28
Override conditions 12-8
Recycling 10-3
Overview (screen) 3-18
Reinfusion 4-57, 4-69
P
Repair 2-5
Particle filter, dialysis fluid 3-4
Residual disinfectant (check) 6-12
Patient card 13-2
Responsible organization (duties) 2-6
Recirculation measurement 12-17
Relocation 10-1
Patient ID 4-128 Patient ID (treatment data sheet) (display / button) 3-19
Restrictions 2-4 Rinse / reinfusion volume 4-69 Rinse connector 7-13, 7-17
Patient, connecting with ONLINE and Single-Needle 4-45
Rinse port catch (gray) 3-8
Rinse port 3-8 Rinse solution bag 7-15, 7-19
Patient, disconnecting with ONLINE 4-59
Risk of tilting 2-11, 10-1
Patient, disconnecting with ONLINE and Single-Needle 4-58
Rocker switch button 3-24
Power connection (supply point) 3-2, 3-16
Selecting the concentrate supply 4-7 Selection screen 3-17 Sequential therapy 13-2 Service door 3-2 ServiceCard 3-7, 13-2 Setting the venous alarm limit 4-13 Setting via numeric keypad 3-23 Setting via rocker switch button 3-24 Setup 4-67
Patient, connecting with ONLINE 4-41
PatientCard 3-7, 4-102, 13-2
Screen, cleaning 6-19
RO 13-3 Room temperature 4-99 Rotor 3-10
Shunt interlock 3-4 Shunt interlock flap 3-4, 3-5 Side effects 2-4 Significance of notes 2-2 Significance of tips 2-2 Significance of warnings 2-2 Single programs 4-91 Single-Needle 3-12, 7-5, 13-2, 14-1 Single-Needle Click-Clack 4-97, 4-114, 7-3, 12-14 Single-Needle design 3-12 Single-Needle operation 14-2 Single-Needle pressure port 3-12 Single-Needle pump 3-12
Power failure (mains failure) 5-20
S
Single-Needle specifications 12-16
Power failure and battery operation 5-20
Safe workload 12-1, 13-2
Single-Needle User setup 4-97
SafeLine™ 7-6, 7-13, 7-17
Single-Needle, description 14-1
Power failure and empty battery 5-21 Power switch 3-16 Preparation 4-1, 12-8 Pressure displays (display / button) 3-19 Pressure holding test 12-10 Pressure tubing 3-12, 14-17 Profiles 4-36, 4-53 Pulse 12-17 Pump housing 3-10 Pump segment 7-12, 7-14, 7-16, 7-18
1-4
SafeLine™ line guide 7-13, 7-17
SN chamber 7-17, 7-19, 12-16
SafeLine™ pump segment 7-13, 7-17
SN hydrophobic filter (WET) 4-84
SafeLine™, inserting / retrofitting 4-111
SN pressure line 7-17, 7-19
SafeLine™, removing 4-110
Sodium profiles 4-36, 4-53
Screen 3-6, 3-18
SN line guide 7-17, 7-19 SN pump segment 7-17, 7-19 Specifications 9-4, 12-1
Screen colors 3-20
Start-up requirements 2-17
Screen failure 5-22 Screen failure sensor 3-6 Screen failure, no screen response 5-22
Start-up screen 3-17 Status (button) 3-18 Status bar 2-10, 3-18, 4-41, 4-44, 4-45, 4-50
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Chapter 1: Index
Status indicator 3-6 Storage 10-3 Storage conditions 10-3, 12-6 Strap for disinfectant canister 3-15 Stroke volume 12-16 Substituate connector (SafeLine™) 7-13, 7-17
Tubing system ONLINEplus™ Single-Needle 7-16
Venous measuring head (BTM) 3-12
Tubing system with rinse solution bag 7-14
Venous monitoring function 3-8, 3-9, 3-11
Tubing system, inserting with ONLINE 4-17
Venous occlusion clamp 3-8
Tubing system, inserting with ONLINE in case of Single-Needle 4-26
Substituate port 3-8 Substituate port catch (blue) 3-8
Tubing system, inserting with rinse solution bag 4-22
Substituate pump 3-8 Substitution 4-93
Tubing system, inserting with rinse solution bag in case of SingleNeedle 4-31
Supply point 3-2, 3-16 Surface cleaning 6-18, 8-3
Tubing system, removing 4-63
Surface disinfection 6-18
Tubing system, Single-Needle with rinse solution bag 7-18
Switching power off 6-20 Switching power on 4-5
Tubing systems 8-2
Symbols 13-4
Tubing systems (description) 7-12
System configurator 2-12
U
T
UF menu 4-35, 4-37 UF parameters 4-35, 4-53 UF profiles 4-36, 4-53
Target group 2-5
UF Timer I/O (button) 3-19
Technical documentation 2-7
UFC measurement 12-10
Technical Safety Checks (TSC) 11-1
Ultrafiltration 4-82, 12-10 User interface 3-17, 4-85
Technical Safety Checks / maintenance 11-1
User setup 4-67, 13-2 UserCard 3-7, 13-2
Technician's card 13-2 Terms 13-1
Venous pressure 3-19 Venous pressure line 7-12, 7-14, 7-16, 7-18 Venous pressure measurement 12-13 Venous pressure port 3-9 Venous tubing system 7-13, 7-14, 7-17, 7-18 Venous tubing system connector 7-12, 7-14, 7-16, 7-18 Vent (mixing chamber) 3-15 Vent (water inlet chamber) 3-15 Volume corridor control 14-40
SYSTEM menu 4-65
T1 test 4-9, 12-8
Venous patient line 7-13, 7-15, 7-17, 7-19
W Warning 5-2 Warnings 2-7 Warnings, consumables and accessories 2-15 Warnings, electricity 2-13 Warnings, hygiene 2-7 Warnings, system-specific 2-10 Warnings, therapy 2-8 Water alarms 13-2
Time 4-66
V
Transmembrane pressure 12-10, 13-2
VAM 5-18
Weekly programs 4-90
Transport 2-5, 10-2
VAM description 5-18
Weight 12-1
ven. hydrophobic filter (WET) 4-84
WET 5-16
VenAcc 14-5
WET description 5-17
VenAcc description 14-6
WET operation 5-17
VenAcc operation 14-8
WET User setup "Alarm processing" (SN hydrophobic filter) 4-84
Transport / storage 10-1 Tray for disinfectant canister 3-15 Treatment 4-39 Treatment course 3-21 Treatment data sheet 3-19 Treatment, observe before and during 4-10 TSC 11-1, 13-3 Tubing system for MIXED HDF 7-20 Tubing system ONLINEplus™ 7-12
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Water supply (permeate) 3-15
VenAcc specifications 12-16 VenAcc surface cleaning 6-19 VenAcc User setup 4-99 Venous bubble catcher 4-18, 4-23, 4-27, 4-32, 7-13, 7-14, 7-16, 7-18
WET User setup "Alarm processing" (ven. hydrophobic filter) 4-84
Venous insertion site / sampling site 7-12, 7-14, 7-16, 7-18 Venous line, changing 4-110
IFU-EN
10B-2015
1-5
Chapter 1: Index
1-6
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IFU-EN
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Chapter 2: Important information
2
Important information
2.1
How to use the Instructions for Use Identification
The document can be identified by the following information on the title page and on the labels, if any: – Software version of the device – Edition of the document – Part number of the document
Footer
The footer displays the following information: – Company name – Device type – The English abbreviation for the document type and the international abbreviation for the document language, e.g., IFU-EN means Instructions for Use in English. – The edition identification, for example, 4A-2013 refers to edition 4A released in 2013 – The page identification, for example, 1-3 refers to chapter 1, page 3
Organization of the chapters
To facilitate the use of documents from Fresenius Medical Care, the organization of the chapters has been standardized in all manuals. There may therefore be chapters within this document without any content. Chapters without content are marked accordingly.
Illustrations
The illustrations used in the documents may differ from the original if this does not have any influence on the function.
Importance of Instructions for Use
These Instructions for Use are part of the accompanying documents and an integral part of the device. They contain all information required for operating the device. The Instructions for Use must be carefully studied before attempting to operate the device. Before the responsible organization can begin to operate the device, the individual responsible for the operation must have been instructed by the manufacturer on how to use the device and must be thoroughly familiar with the contents of the Instructions for Use. The device may only be operated by individuals who have been trained and certified in the proper operation and handling of the device. The training must be documented in the enclosed Training Record.
Changes
Changes to documents will be released as new editions or supplements. In general, this manual is subject to change without notice.
Reproduction
Reproduction, even in part, is only permitted with written approval.
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Chapter 2: Important information
2.2
Significance of warnings Warning Advises the operator that failure to observe this information can result in personal injury.
2.3
Significance of notes Note Advises the operator that failure to observe this information can – cause damage to the device. – required functions not being executed at all or being executed incorrectly.
2.4
Significance of tips Tip Information providing useful tips for easy handling.
2-2
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Chapter 2: Important information
2.5
Brief description Dialysis treatments with the hemodialysis system can be performed without any additional equipment. The hemodialysis system controls and monitors the dialysate circuit and the extracorporeal blood circuit. There are four buttons on the monitor All entries are made via a high-resolution color monitor (touch screen). The current treatment data are shown on the display. In the dialysate circuit, purified water is heated, degassed, mixed with hemodialysis concentrate, and delivered to the dialyzer. Inflowing and outflowing volumes are balanced volumetrically. The pressure at the dialyzer is adjusted depending on the ultrafiltration rate selected and the type of dialyzer used. The blood is transported through the dialyzer via the extracorporeal blood circuit. The blood can be continuously heparinized. An air bubble detector prevents the infusion of air. Any dangerous loss of blood is prevented by a blood leak detector, a fluid sensor, and by monitoring the venous return pressure. The arterial pressure monitoring unit detects an aspiration of the needle in the vessel. The hemodialysis system is designed for both acetate dialysis and bicarbonate dialysis. The mixing ratio, the Na+ concentration and the bicarbonate concentration can be programmed within specific limits. The hemodialysis system also allows the programming of Na and UF profiles. ISO-UF (ultrafiltration without dialysate flow) can be performed. The dialysate flow can be adjusted from 100 to 1000 ml/min, in increments of 100 ml/min. The AutoFlow function automatically regulates the dialysate flow as a function of the blood flow rate. The hemodialysis system reflects the latest state of technology. It is equipped with all safety systems required for its function and for patient safety. It complies with the requirements of IEC 60601-1. The hemodialysis system is classified as Class II b (MDD) equipment. The hemodialysis system contains, among others, "Free Software". For further information please refer to Chapter 15.
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Chapter 2: Important information
2.6
Intended use
2.6.1
Intended purpose The device is used for the extracorporeal blood treatment of patients suffering from renal insufficiency. Consumables with a service life adapted to the duration of therapy have to be used for the treatment; see specification in the operator documentation of the consumables.
2.6.2
Specified application The device has been specified by the manufacturer for the following purposes: – treatment of patients with a body weight of 40 kilograms or more. For this purpose, the safety systems and protective devices are designed for possible fault conditions and defects. For patients with a lower body weight, the HD-PAED option is available (see Chapter 14.7 on page 14-59). – operation in rooms suitable for dialysis located in professional health care institutions or for the home healthcare environment.
2.6.3
Side effects During hemodialysis treatments, hypotension, nausea, vomiting and cramps have been reported to occur, among others. Observe the package inserts enclosed with the hemodialysis concentrates and dialyzers, etc. To reduce possible side effects of the treatment, the therapy specification should be customized for each patient.
2.6.4
Contraindications – Hyperkalemia (only with potassium-containing hemodialysis concentrates) – Hypokalemia (only with potassium-free hemodialysis concentrates) – Uncontrollable coagulation anomalies A different method of extracorporeal treatment may be indicated for hemodynamically unstable patients.
2.6.5
Restrictions None
2-4
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Chapter 2: Important information
2.6.6
Interaction with other systems Due to friction at the pump segment, very low electrostatic discharges into the tubing system may occur during operation of a line roller pump. Because of their low charge strength, these discharges do not represent a direct risk to patients or operators. If ECG devices are used at the same time, these discharges may, in rare cases, cause periodic interference of the ECG signal. In order to minimize this interference, observe the recommendations of the ECG device manufacturer, e.g.: – correct electrode position – use of specific electrodes with low contact impedance
2.6.7
Target group The device may only be installed, operated and used by individuals who have the required training, knowledge and experience and can prove that they have been successfully instructed.
2.6.8
Repair, maintenance, transport
Warning Start-up, extensions, adjustments, calibrations, maintenance procedures, modifications or repairs must only be carried out by the manufacturer or persons authorized by the manufacturer. The Technical Safety Checks (TSC), the maintenance procedures and further explanations on how to perform them are included in the Service Manual (see Chapter 11 on page 11-1). Use only original spare parts. For identifying and ordering spare parts, test equipment and tools, always use the electronic spare parts catalog. Transport and storage (see Chapter 10 on page 10-1).
2.6.9
Expected service life If the TSC are performed to the extent prescribed and in the time intervals specified, safe operation will be ensured in the intervening time. In addition, the manufacturer recommends to perform maintenance procedures in the same time interval to prevent device malfunction due to wear and tear. With each TSC, the "expected service life" according to IEC 606011:2005 therefore will be prolonged until the next prescribed TSC check.
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