Fresenius Medical
5008S Hemodialysis system Instructions for Use Part no F40003105 Sw ver 4.58 Edition 11A-2015
Instructions for Use Part
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5008S Hemodialysis system Instructions for Use Software version: 4.58 Edition: 11A-2015 Part no.: F40003105 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
Intended use ... 2-4 Intended purpose... 2-4 Specification of use ... 2-4 Side effects... 2-4 Contraindications... 2-4 Interaction with other systems ... 2-5 Therapy restrictions ... 2-5 Target group ... 2-5
2.7
Considerations for working on the device... 2-5
2.8
Expected service life ... 2-6
2.9
Duties of the responsible organization ... 2-6
2.10
Operator responsibility ... 2-7
2.11
Disclaimer of liability... 2-8
2.12 2.12.1 2.12.2 2.12.3 2.12.4 2.12.5
Warnings ... 2-8 Warnings, hygiene... 2-8 Warnings, therapy ... 2-9 Warnings, system-specific... 2-12 Warnings, electrical ... 2-14 Warnings, consumables and accessories ... 2-16
2.13
Additional optional equipment supplied by Fresenius Medical Care... 2-17
2.14
Addresses ... 2-18
Design 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6
Views ... 3-1 Front view ... 3-1 Left side view... 3-2 Right side view ... 3-4 Rear view... 3-6 Monitor front ... 3-7 Monitor rear ... 3-10
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3.1.7 3.1.8 3.1.9 3.1.10
Extracorporeal Blood Circuit Module ... 3-11 Hydraulics ... 3-15 Hydraulics connectors ... 3-16 External connection options... 3-17
3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5
User interface... 3-19 After switching on the device ... 3-19 Overview (screen)... 3-20 General operating concept ... 3-22 Examples for data entry (treatment data) ... 3-25 Screen saver... 3-27
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
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... 4-11 Setting up and priming the extracorporeal blood circuit... 4-16 4.1.6.1 Double-Needle – setting up and priming with ONLINEplus™ ... 4-17 4.1.6.2 Double-Needle – setting up and priming with rinse solution bag ... 4-24 4.1.6.3 Single-Needle – setting up and priming with ONLINEplus™ ... 4-30 4.1.6.4 Single-Needle – setting up and priming with rinse solution bag ... 4-35 Checking / setting the dialysate parameters... 4-40 Checking / setting the UF parameters ... 4-40 Checking / setting the Na and UF profiles ... 4-41 Checking / setting the heparin pump parameters ... 4-43 Checking / setting the Single-Needle parameters ... 4-43 Treatment ... 4-45 Screen ... 4-45 Connecting the patient... 4-46 4.2.2.1 Double-Needle – treatment with ONLINEplus™ ... 4-47 4.2.2.2 Double-Needle – treatment with rinse solution bag... 4-51 4.2.2.3 Single Needle – treatment with ONLINEplus™ ... 4-52 4.2.2.4 Single Needle – treatment with rinse solution bag ... 4-57 Changing the dialysate parameters ... 4-60 Changing the UF parameters ... 4-60 Na and UF profiles... 4-60 Changing the heparin pump parameters ... 4-61 Single-Needle ... 4-61
4.3.3 4.3.4 4.3.5
Reinfusion ... 4-63 Screen ... 4-63 Disconnecting the patient ... 4-64 4.3.2.1 Double-Needle – disconnecting the patient when using ONLINEplus™ ... 4-65 4.3.2.2 Double-Needle – disconnecting the patient when using rinse solution bag ... 4-67 4.3.2.3 Single Needle – disconnecting the patient when using ONLINEplus™ ... 4-69 4.3.2.4 Single Needle – disconnecting the patient when using rinse solution bag ... 4-69 Emptying the dialyzer ... 4-70 Emptying the bibag® ... 4-70 Removing the tubing system ... 4-71
4.4
System ... 4-73
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4.4.1 4.4.2
SYSTEM – selecting / setting ... 4-73 SYSTEM – overview... 4-74 4.4.2.1 SYSTEM settings ... 4-74 4.4.2.2 Service (Service setup) ... 4-76 4.4.2.3 User setup ... 4-76 4.4.2.4 Applications ... 4-76
4.5
Service (Service setup) ... 4-76
4.6 4.6.1 4.6.2
User setup ... 4-77 User setup – selecting / setting ... 4-77 User setup – overview ... 4-78 4.6.2.1 Tubing system ... 4-78 4.6.2.2 Blood pump ... 4-78 4.6.2.3 Rinse / reinfusion volume (only for preparation with NaCl solution)... 4-79 4.6.2.4 Anticoagulation... 4-80 4.6.2.5 Dialysate ... 4-82 4.6.2.6 Ultrafiltration ... 4-84 4.6.2.7 Alarm processing... 4-85 4.6.2.8 User interface ... 4-88 4.6.2.9 Cleaning ... 4-91 4.6.2.10 Auto On ... 4-92 4.6.2.11 Emergency (response after pressing the Emergency button) ... 4-95 4.6.2.12 Extended safety ... 4-95 4.6.2.13 ONLINE ... 4-96 4.6.2.14 OCM ... 4-99 4.6.2.15 Single-Needle (can only be selected if the device option exists) ... 4-100 4.6.2.16 Miscellaneous ... 4-100 4.6.2.17 BPM (can only be selected if the device option exists) ... 4-101 4.6.2.18 BTM (can only be selected if the device option exists) ... 4-102 4.6.2.19 VenAcc (can only be selected if the device option is available) ... 4-103 4.6.2.20 Home-HD (can only be selected if the device option exists) ... 4-104
4.7 4.7.1 4.7.2
Applications ... 4-105 APPLICATIONS – selecting / setting... 4-105 APPLICATIONS – overview ... 4-106 4.7.2.1 Create PatientCard ... 4-106 4.7.2.2 Training ... 4-106 4.7.2.3 Fluid sampling using the sampling set for hygiene tests ... 4-107
4.8 4.8.1
Other functions... 4-109 PatientCard... 4-109 4.8.1.1 Loading the treatment parameters ... 4-109 4.8.1.2 Saving the treatment parameters ... 4-109 Emergency button ... 4-110 Emptying / changing the bibag® ... 4-110 Changing filter 1 / filter 2... 4-111 Cleaning the dialysis fluid particle filter... 4-113 Fluid sampling using the sampling valve (option)... 4-113 Removing lines during preparation... 4-113 Removing lines during treatment... 4-114 4.8.8.1 Changing the arterial tubing system... 4-114 4.8.8.2 Changing the venous tubing system ... 4-114 4.8.8.3 Removing the SafeLine™ ... 4-114 4.8.8.4 SafeLine™ setup... 4-115 4.8.8.5 Removing all lines ... 4-115 Circulation... 4-116 Administering infusions... 4-116
4.8.2 4.8.3 4.8.4 4.8.5 4.8.6 4.8.7 4.8.8
4.8.9 4.8.10
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4.8.11 4.8.12 4.8.13
4.8.14
4.8.15
5
Setting the level in the venous bubble catcher ... 4-117 Single-Needle Click-Clack ... 4-118 OCM (Online Clearance Monitoring) ... 4-121 4.8.13.1 Observe before use ... 4-121 4.8.13.2 Description ... 4-121 4.8.13.3 Menu overview ... 4-123 4.8.13.4 OCM chart ... 4-124 4.8.13.5 Checking / setting the OCM parameters ... 4-124 4.8.13.6 Stability criteria ... 4-125 4.8.13.7 Starting the OCM... 4-125 4.8.13.8 Stopping the OCM ... 4-125 ONLINEplus™ ... 4-127 4.8.14.1 Observe before use ... 4-127 4.8.14.2 Description ... 4-127 4.8.14.3 Menu overview ... 4-128 4.8.14.4 Preparation, treatment, reinfusion ... 4-129 4.8.14.5 AutoSub plus description... 4-129 4.8.14.6 Manual substitution description ... 4-129 Network... 4-131 4.8.15.1 Observe before use ... 4-131 4.8.15.2 DataXchange Panel ... 4-131
Alarm processing 5.1
Repeated confirmation of a message ... 5-1
5.2
Performance of the alarm system ... 5-2
5.3
Alarm systems ... 5-3
5.4
Alarm categories... 5-3
5.5
Alarm responses... 5-4
5.6
Operating status indicator (traffic light) ... 5-4
5.7
Audible alarms ... 5-4
5.8
Messages (alarm / warning / info) ... 5-5
5.9
Preset limit values ... 5-7
5.10
Multiple alarms... 5-7
5.11
Air detected below the venous bubble catcher ... 5-8
5.12
Microbubbles detected below the venous bubble catcher... 5-12
5.13
Venous pressure alarm ... 5-18
5.14
Arterial pressure alarm ... 5-18
5.15 5.15.1 5.15.2 5.15.3
BLK (Blood line kinking and filter clotting monitoring) ... 5-19 Observe before use ... 5-19 Description... 5-19 Alarm processing ... 5-20
5.16 5.16.1 5.16.2 5.16.3
WET (Wet Transducer Protector) ... 5-20 Observe before use ... 5-20 Description... 5-21 Alarm processing ... 5-21
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6
7
5.17 5.17.1 5.17.2 5.17.3
VAM (Venous Access Monitor) ... 5-22 Observe before use ... 5-22 Description... 5-22 Alarm processing... 5-23
5.18
Blood pump stop alarm ... 5-23
5.19
Blood pump stop alarm – Single-Needle (option) ... 5-23
5.20
Blood leak ... 5-24
5.21
Conductivity... 5-25
5.22
Power failure (power outage) ... 5-26
5.23
Screen failure... 5-26
5.24
Performing a manual reinfusion ... 5-28
5.25
Manually opening the arterial pressure measurement unit... 5-29
Cleaning / disinfection 6.1
Observe before use ... 6-1
6.2
Basic requirements ... 6-3
6.3
Connecting the disinfectant containers ... 6-4
6.4
Starting a cleaning program... 6-7
6.5
Stopping a cleaning program... 6-11
6.6
Cleaning program completed... 6-12
6.7 6.7.1 6.7.2
Check for residual disinfectant ... 6-13 Automatic check for residual disinfectant ... 6-14 Manual check for residual disinfectant ... 6-14
6.8 6.8.1 6.8.2 6.8.3
Endless rinse ... 6-16 Observe before use ... 6-16 Central disinfection ... 6-17 Central free rinse ... 6-18
6.9
Surface cleaning / surface disinfection... 6-19
6.10
Switching off the hemodialysis system ... 6-20
6.11
Changing filter 1 / filter 2 ... 6-21
Functional description 7.1
Extracorporeal blood circuit... 7-2
7.2
Extracorporeal blood circuit with additional functions ... 7-4
7.3
Hydraulics ... 7-6
7.4
Description bibag® ... 7-8
7.5 7.5.1 7.5.2
Tubing systems (description) ... 7-10 Tubing system, Double-Needle ONLINEplus™ ... 7-10 Tubing system, Double-Needle with rinse solution bag... 7-12
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8
9
7.5.3 7.5.4
Tubing system, Single-Needle ONLINEplus™ ... 7-14 Tubing system, Single-Needle with rinse solution bag ... 7-16
7.6
Heparin syringe... 7-18
7.7
Dialyzer connectors... 7-18
Consumables, accessories, additional equipment 8.1
To be observed in the "Consumables, accessories, additional equipment" chapter... 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 9.1.7
Connection requirements ... 9-1 Environment... 9-1 Power supply (electrical power network) ... 9-1 9.1.2.1 General requirements... 9-1 9.1.2.2 Additional requirements for operation in the home healthcare environment ... 9-3 Water drain ... 9-4 Water drain ... 9-4 Dialysis water... 9-4 Concentrates ... 9-5 Dialysis fluid... 9-5
9.2 9.2.1 9.2.2
Initial start-up ... 9-6 Observe before initial start-up... 9-6 Performing the initial start-up... 9-6
10 Transport / storage 10.1
Relocation ... 10-2
10.2
Transport ... 10-3
10.3 10.3.1
Storage ... 10-3 Storage conditions ... 10-3
10.4 10.4.1 10.4.2
Environmental compatibility / disposal ... 10-4 Information for the responsible organization... 10-4 Information for recycling and waste disposal services... 10-4
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11 Technical safety checks / maintenance procedures 11.1
Important information on the technical safety checks/maintenance procedures... 11-1
12 Specifications 12.1
Dimensions and weight ... 12-1
12.2
Identification label (device marking) ... 12-1
12.3
Electrical safety ... 12-2
12.4
Electrical power supply ... 12-2
12.5
Fuses ... 12-3
12.6 12.6.1
Information on electromagnetic compatibility... 12-3 Minimum distances between radiation source and device ... 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
Operating programs ... 12-8
12.12
Dialysate circuit and safety systems... 12-10
12.13
Extracorporeal blood circuit and safety systems ... 12-13
12.14
DIASAFE® plus ... 12-15
12.15
OCM ... 12-15
12.16
ONLINEplus™ ... 12-16
12.17
Network ... 12-17
12.18
Radio (option) - in monitor ... 12-17
12.19
Single-Needle (option) ... 12-18
12.20
VenAcc (option) monitoring unit... 12-18
12.21
BPM (option) ... 12-18
12.22
BTM (option) ... 12-19
12.23
HOME-HD (option) remote control... 12-20
12.24
Residual-current device* (option) ... 12-20
12.25
Materials used... 12-21
13 Definitions 13.1
Definitions and terms... 13-1
13.2
Abbreviations... 13-3
13.3
Symbols... 13-4
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13.4
Symbols for consumables ... 13-7
13.5
Certificates ... 13-8
14 Options 14.1 14.1.1 14.1.2 14.1.3 14.1.4
Single-Needle (SN) option... 14-1 Observe before use ... 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 use ... 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... 14-11 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
BPM option (Blood Pressure Monitor)... 14-15 Observe before use ... 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 14.3.6 Attaching the blood pressure cuff ... 14-22 14.3.7 Checking / setting the inflation pressure / warning limits ... 14-23 14.3.8 Starting a blood pressure measurement... 14-23 14.3.8.1 Single measurement ... 14-23 14.3.8.2 Interval (long-term interval measurement) ... 14-24 14.3.8.3 Quick (short-term interval measurement) ... 14-25 14.3.9 Blood pressure measurement completed ... 14-25 14.3.10 Stopping a blood pressure measurement... 14-25 14.3.11 Entering BPM data manually ... 14-26 14.3.12 Alarm processing (blood pressure / pulse) ... 14-26 14.4 14.4.1 14.4.2 14.4.3 14.4.4
BTM option (Blood Temperature Monitor) ... 14-27 Observe before use ... 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
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14.4.5 14.4.6 14.4.7 14.4.8 14.5 14.5.1 14.5.2 14.5.3 14.5.4 14.5.5
14.4.4.3 BTM events ... 14-32 Preparation ... 14-33 Recirculation... 14-34 Temperature control ... 14-35 Alarm processing... 14-35
14.5.15
HOME-HD option ... 14-37 Observe before use ... 14-37 Description... 14-37 Remote control – front view... 14-38 Menu overview ... 14-39 Logging in / finding / logging out the remote control... 14-40 14.5.5.1 Logging in the remote control... 14-40 14.5.5.2 Finding the remote control... 14-40 14.5.5.3 Logging out the remote control ... 14-40 HOME-HD screen saver overview... 14-41 Screen colors... 14-43 Description of HOME-HD screen saver... 14-43 General operating concept of the HOME-HD screen saver ... 14-44 Example for data entry (venous pressure / setting the alarm window)... 14-45 Operation... 14-47 14.5.11.1Arterial pressure / setting the alarm window ... 14-47 14.5.11.2Venous pressure / setting the alarm window... 14-47 14.5.11.3Changing the UF goal ... 14-48 14.5.11.4Changing the UF time ... 14-48 14.5.11.5Starting / stopping the UF timer... 14-48 14.5.11.6Setting the blood flow ... 14-48 14.5.11.7Starting/ stopping the blood system ... 14-49 14.5.11.8Starting/stopping a blood pressure measurement... 14-49 Charging the remote control battery ... 14-49 Removing and installing the remote control battery ... 14-50 Other functions ... 14-51 14.5.14.1Emergency key (remote control) ... 14-51 14.5.14.2Battery test (remote control)... 14-51 14.5.14.3Self-test (remote control)... 14-52 Alarm processing... 14-52
14.6 14.6.1 14.6.2 14.6.3 14.6.4
Top tray option ... 14-53 Specification of use ... 14-53 Observe before use ... 14-53 Description... 14-53 Operation... 14-54
14.7 14.7.1 14.7.2 14.7.3 14.7.4 14.7.5
Residual-current device option* ... 14-55 Specification of use ... 14-55 Observe before use ... 14-55 Description... 14-55 Operation... 14-56 Testing interval for RCD ... 14-57
14.5.6 14.5.7 14.5.8 14.5.9 14.5.10 14.5.11
14.5.12 14.5.13 14.5.14
15 Appendix 15.1
Instructions on the use of “Free software”... 15-1
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Chapter 1: Index
1
Index
A Abbreviations 13-3 Acetate dialysis 4-10, 13-1 Adapter (SafeLine™) 7-11, 7-15 Additional optional equipment 2-17 Addresses 2-18
Audible info 6-12
Body temperature control 12-19
Auto Off 6-12
Bonding connection 3-16, 9-2
Auto On 4-92
BPM 14-15
AutoFlow 12-12
BPM (User setup) 4-101
Auto-Single-Needle 12-18
BPM blood pressure cuffs 3-2, 14-17
AutoSub plus 4-129
BPM data, entering manually 14-26
Air bubble detector 3-14, 12-14
B
Air removal 5-9
Barrel holder with syringe detector 3-13
BPM operation 14-18
Battery 9-3, 10-3, 10-4, 12-6, 12-18, 12-23
BPM pressure tubing 3-2
Alarm 5-5 Alarm mute 13-6 Alarm output 3-18, 13-5 Alarm processing 4-85, 5-1 Anticoagulation 4-80
bibag® 4-8, 4-70, 7-8 bibag® flap 3-15 bibag® port 3-15
Appendix 15-1
bibag®, connecting 4-8
Applications 4-105 AquaUNO / AquaC UNO H 2-17, 3-17, 12-7, 13-5 Arterial insertion site / sampling site 7-10, 7-12, 7-14, 7-16 Arterial line guide 7-10, 7-12, 7-14, 7-16 Arterial measuring head (BTM) 3-12
bibag®, emptying / changing 4-110 Bicarbonate dialysis 4-8, 13-1 Bicarbonate suction tube (blue) 3-15 Bld. press. (display / button) (BPM) 3-21
BPM description 14-16 BPM pressure port 3-2 BPM specifications 12-18 Bracket (heparin pump) 3-13 Brake 3-2 Brief description 2-3 BTM 14-27 BTM (arterial measuring head) 3-12 BTM (User setup) 4-102 BTM (venous measuring head) 3-12 BTM description 14-28
BLK 5-19
BTM design 3-12
Arterial occlusion clamp 3-11
BLK description 5-19
Arterial patient line 7-10, 7-12, 7-14, 7-16
BLK User setup "Extended safety" Kinking (BLK) 4-95
BTM Extracorporeal Blood Circuit 7-4
Arterial pressure 3-21
Blood alarms 7-3, 13-1
Arterial pressure dome 4-18, 4-24, 4-31, 4-36, 7-10, 7-12, 7-14, 7-16
Blood flow 7-18
BTM surface cleaning 6-20
Blood flow (display / button) 3-21
Bubble catcher 13-1
Blood inlet of the dialyzer 7-18
Bubble catcher (venous) 4-19, 4-25, 4-31, 4-36, 7-11, 7-13, 7-15, 7-17
Arterial pressure measurement unit 3-11, 4-15, 4-18, 4-24, 4-31, 4-36, 7-2
Blood leak 5-24
Arterial pressure measurement unit, opening manually 5-29
Blood line kinking (BLK) 5-19
Arterial pump segment 7-10, 7-12, 7-14, 7-16 Arterial tubing system 7-10, 7-12, 7-14, 7-16 Arterial tubing system connector 7-10, 7-12, 7-14, 7-16 Arterial tubing system, changing 4-114 Audible alarm 12-15
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Blood leak detector 12-10 Blood outlet of the dialyzer 7-18 Blood pressure cuff (BPM) 3-2, 14-17 Blood Pressure Monitor (BPM) 14-15
BTM operation 14-29 BTM specifications 12-19
C Card for use for patient for Treatment data documentation 13-2 Card slot 3-10
Blood pressure monitor (BPM) 12-19
Central Delivery System (CDS) 4-10
Blood pump 3-11, 3-13, 4-78
Certificates 13-8
BLOOD SYSTEM menu 4-1
Changing filter1 / filter2 4-111
IFU-EN
1-1
Chapter 1: Index
Changing settings with the number buttons (example) 3-25
Degreasing 8-3
E
Descaling 8-3
EBC 13-3
Changing settings with the rocker switch button (input example) 3-26
Description of HOME-HD 14-37
Chart time scale (User setup) 4-74
Dialysate flow 7-18, 12-12
Check for residual disinfectant 6-13 Circulation 4-116 Cleaning / disinfection 6-1 Cleaning programs 12-9 Collection bag 7-13, 7-17
Design 3-1
EcoFlow 4-10, 12-12 Electrical power supply 12-2
Dialysate flow (display) 3-20
Electrical safety 12-2
Dialysate inlet port 7-18
Electromagnetic compatibility 12-3
Dialysate inlet tube 3-4, 7-18
Electromagnetic compatibility (EMC) 13-3
Dialysate lines 3-4, 4-22, 4-27, 4-33, 4-38
Concentrate rack 3-2
Dialysate menu 4-3, 4-40, 4-42, 4-60, 4-70, 4-90, 4-110
Concentrate suction tube (red) 3-15
Dialysate outlet port 7-18
Concentrates 4-7, 9-5, 12-11 Conductivity 13-2 Conductivity alarm 5-25 Connection, venous pressure line 7-11, 7-13, 7-15, 7-17 Connector for CDS 1, red 3-16 Connector for CDS 2, red 3-16 Connector on Single-Needle chamber (Luer lock) 7-15, 7-17 Connector on venous bubble catcher (Luer lock) 7-11, 7-13, 7-15, 7-17 Connector postdilution 7-11, 7-15
EBM 13-3
Dialysate outlet tube 3-4, 7-18 Dialysate parameters 4-40, 4-60 Dialysate temperature 12-11
EMC 12-3, 13-3 Emergency 4-95 Emergency button 3-21, 4-95, 4-110 Emergency key 14-51 Emergency operation handle 3-13 Emptying the dialyzer 4-70
Dialysis fluid particle filter, cleaning 4-113
Endless rinse (cleaning / disinfection) 6-2, 6-16
Dialysis water 3-16, 13-1, 13-2 Dialyzer 7-10, 7-12, 7-14, 7-16
Environmental compatibility / disposal 10-4
Dialyzer connectors 7-18
Expected service life 2-6
Dialyzer coupling, inlet 7-18
External connection options 3-6, 3-17, 12-7
Dialyzer coupling, outlet 7-18
Extracorporeal Blood Circuit Module (EBM) 3-1, 3-11, 4-18, 4-24, 4-30, 4-35, 13-3
Dialyzer couplings 3-5 Dialyzer holder 3-4, 3-5 Dialyzers 8-1
Connector predilution 7-11, 7-15
DIASAFE®plus 8-2, 12-15
Considerations for working on the device 2-5
DIASAFE®plus, changing 4-111
F
Dimensions 12-1
Fan filter 3-6
Consumables, accessories, additional equipment 8-1
Disclaimer of liability 2-8
Consumption data / energetic data 12-5 Contraindications 2-4 Create PatientCard 4-106 Current messages 3-20
D Data entry, examples (treatment data) 3-25
Filter 1 – DIASAFE®plus 3-6, 7-4
Disinfectant 8-3
Filter 2 – DIASAFE®plus 3-6, 7-4
Disinfectant connector, black 3-16
Filter change (filter1 / filter2) 4-111
Disinfectant connector, yellow 3-16
Filter cover 3-6 Flow alarm 12-13
Disinfectant container (strap) 3-16
Flow chart 7-6
Disinfectant containers, connecting 6-4
Fluid sampling using the sampling set for hygiene tests 4-107
Disinfectant indicators 8-3
Fluid sampling using the sampling valve (option) 4-113
Disposal 10-4
Flush 12-9
DataXchange Panel 4-131
Double-Needle 4-16, 4-17, 4-24, 4-46, 4-47, 4-51, 4-64, 4-65, 4-67
Flush drain 3-16
DataXchange Panel operation 4-132
Double-Needle ONLINEplus™ tubing system 7-10
Front view 3-1
Define options 4-89
Drain 3-16
Functional description 7-1
Definitions 13-1
Duties of the responsible organization 2-6
Fuses 12-3
Definitions and terms 13-1
1-2
Free software 2-3, 15-1
Fresenius Medical Care 5008S IFU-EN
Chapter 1: Index
G
Info (button) 3-21
General operating concept 3-22
Infusion 4-116
Groove 3-12
Infusions, administering 4-116 Initial start-up 9-6 Installation 9-1
H Handle for emergency operation 3-13 Hemoconcentration 13-1 Hemodialysis concentrates 8-2 Hemodialysis system, switching off 6-20 Hemodialysis system, switching on 4-5 Heparin 4-12, 4-43
HEPARIN menu 3-21, 4-4, 4-43 Heparin pump 2-16, 3-12, 3-13, 4-12, 7-2, 12-14
M
Intended purpose 2-4
MA 13-3
Intended use 2-4
Main power switch 3-6
Interaction with other systems 2-5
Maintenance procedures 11-1, 13-3
ISO UF 13-2 IV pole 3-4, 3-5
J Jaws of the spring clip (heparin pump) 3-13
Heparin (display) 3-21 Heparin line 7-11, 7-13, 7-15, 7-17
Luer lock connector on venous bubble catcher 7-11, 7-13, 7-15, 7-17
K Kinking (BLK) (User setup) 4-95 Kinking / clotting 4-95, 5-19
Manual reinfusion, performing 5-28 Materials 12-21, 12-23 Materials used 12-21 Maximum total weight 12-1, 13-2 Medical electrical equipment 13-2 Menu bar 3-21 Menu panel 3-21 Menu structure, design 3-24 Messages 5-5
Kt/V 4-121
Microbiology 9-4, 9-5
Heparin pump parameters 4-43, 4-61
Kt/V warning 4-99
Microbubbles 5-12
Heparin syringe 4-18, 4-25, 4-31, 4-36, 7-11, 7-13, 7-15, 7-17, 8-2
L
Miscellaneous (User setup) 4-100
LAN (network) 3-18, 12-17, 13-5
Monitor 3-1, 3-7, 3-10
Leakage sensor flap, hydraulics 3-16
Monitor arm 3-10
Holder for Single-Needle chamber 3-11 HOME-HD 14-37 Home-HD charging cradle 3-2
Leakage sensor, Extracorporeal Blood Circuit Module 3-12
HOME-HD operation 14-39
Leakage sensor, hydraulics 3-16
Home-HD remote control 3-2, 14-38 HOME-HD specifications 12-20 Home-HD user setup 4-104 How to use the Instructions for Use 2-1 Hydraulics 3-1, 3-6, 3-15, 3-16
LED screen 10-4, 12-23 LEDs / keys 3-8 Level detector 3-14, 7-2, 12-14 Levers of the spring clip (heparin pump) 3-13 Line guide 3-13
Hydraulics connectors 3-6, 3-16
Line holder for the SafeLine™ 3-12
Hydrophobic filter in the SingleNeedle pressure line 7-15, 7-17
Line holders 3-11, 3-12
Hydrophobic filter in the venous pressure line 7-11, 7-12, 7-14, 7-16
Lines, removing during preparation 4-113
I
Lines, removing all 4-115
Lines, removing during treatment 4-114
Microbubbles, removal 5-15
Mute 3-7, 3-8, 5-2, 13-5
N Na profiles 4-41, 4-60 Network 4-131 Network (LAN) 3-18, 4-131, 12-17, 13-5 Non-medical electrical equipment 13-2 Notes (significance) 2-2 Number buttons (input example) 3-25
O OCM 4-121 OCM (User setup) 4-99 OCM description 4-121
Loudness (audible alarm) 4-74
OCM operation 4-123
Identification label 12-1
Loudspeaker 3-10
OCM specifications 12-15
Important information 2-1
Luer lock connector on SingleNeedle chamber 7-15, 7-17
ONLINE (bolus) 4-49, 4-55, 4-97
Info 5-5
Fresenius Medical Care
5008S
IFU-EN
ONLINE Priming Set 4-17
1-3
Chapter 1: Index
Rinse solution bag 7-13, 7-17
Power failure and battery operation 5-26
RO 13-3
Power failure and empty battery 5-26
Rocker switch button (input example) 3-26
Power outage (power failure) 5-26
Room temperature 4-102
ONLINEplus™ operation 4-128
Power supply connection 3-6
Rotor 3-13
ONLINEplus™ specifications 12-16
Pre- / postdilution connector (SafeLine™) 7-11, 7-15
ONLINEplus™ 4-127 ONLINEplus™ description 4-127 ONLINEplus™ design 3-11 ONLINEplus™ Extracorporeal Blood Circuit 7-4, 7-5
ONLINEplus™ surface cleaning 6-19 ONLINEplus™ tubing system 7-10 ONLINEplus™ tubing system Single-Needle 7-14
S
Preparation 4-1, 12-8
Safe working load 12-1, 13-2
PREPARATION menu 4-2
SafeLine™ 7-11, 7-15
Pressure displays (display / button) 3-21
SafeLine™ line guide 7-11, 7-15
Pressure holding test 12-10
ONLINEplus™ User setup 4-96
Pressure tubing (BPM) 3-2, 14-17
Opening the DataXchange Panel (User setup) 4-88
Profiles 4-41, 4-60
Operating conditions 12-4
Pump housing 3-13
Operating mode (display) 3-20
Push handle 3-6
Operation 4-1 Operator responsibility 2-7 Operator setup 13-2 Optical detector 3-14, 4-19, 4-25, 4-32, 4-37, 12-14 Options 14-1 Overflow (water inlet chamber) 3-16 Overview (screen) 3-20
P Particle filter, dialysis fluid 3-6
SafeLine™, removing 4-114 SafeLine™, setup 4-115
Pulse 12-19
Sampling valve (option) 3-4 Screen 3-8, 3-20 Screen colors 3-22
Operating programs 12-8 Operating status indicator (traffic light) 3-7
SafeLine™ pump segment 7-11, 7-15
Screen failure 5-27
R Radio, specifications 12-17 Reaction ven. window alarm 4-87, 5-18
Screen failure – no screen response 5-27 Screen failure – screen dark or display distorted 5-27
Rear view 3-6
Screen failure sensor 3-7
Recessed grip 3-10
Screen saver 3-27
Rechargeable battery 10-4, 12-2, 12-23
Screen, cleaning 6-20
Recirculation 14-28
Selecting the concentrate supply 4-7
Recirculation measurement 12-19
Selection screen 3-19
Recording treatments with control functions 12-19
Sequential therapy 13-2
Recycling 10-4
ServiceCard 3-10, 13-2
Reinfusion 4-63, 4-79
Service life 2-6
Patient ID 3-21, 4-132
Relocation 10-2
Patient, connecting with ONLINE 4-47
Setting the level in the SingleNeedle chamber 4-61
Remote control – HOME-HD (option) 3-2, 12-20, 14-38
Patient, connecting with ONLINE and Single-Needle 4-52
Setting the level in the venous bubble catcher 4-117
Residual disinfectant (check) 6-13
Setting the venous alarm limit 4-14
Residual-current device 12-20
Setup 4-77
Patient, disconnecting with ONLINE 4-65 Patient, disconnecting with ONLINE and Single-Needle 4-69 PatientCard 3-10, 13-2 Permeate 13-1, 13-2 Power cable socket (power supply connection) 3-6 Power failure (power outage) 5-26
1-4
Responsible organization (duties) 2-6 Reverse osmosis unit (User setup) 4-100
Shunt interlock 3-4 Shunt interlock flap 3-4, 3-5 Side effects 2-4 Side view 3-2, 3-4
Rinse / reinfusion volume (User setup) 4-79
Significance of notes 2-2
Rinse connector 7-11, 7-15
Significance of tips 2-2
Rinse port 3-12
Significance of warnings 2-2
Rinse port catch (gray) 3-12
Single programs (User setup) 4-94
Fresenius Medical Care 5008S IFU-EN
Chapter 1: Index
Single-Needle 3-11, 7-5, 13-2, 14-1
Switching on (hemodialysis system) 4-5
Single-Needle (User setup) 4-100
Symbols 13-4
Single-Needle chamber 7-15, 7-17, 12-18
Symbols for consumables 13-7
Single-Needle Click-Clack 4-100, 4-118, 7-3, 12-15 Single-Needle design 3-11 Single-Needle line guide 7-15, 7-17 Single-Needle operation 14-2 Single-Needle pressure line 7-15, 7-17 Single-Needle pressure line connector 7-15, 7-17
Syringe barrel 7-18 Syringe plunger 7-18 Syringe wings 7-18 System installer 12-17 SYSTEM menu 4-73
T T1 test 4-10, 12-8 Target group 2-5
Tubing system, setup with ONLINE in case of Single-Needle 4-30 Tubing system, setup with rinse solution bag 4-24 Tubing system, setup with rinse solution bag in case of SingleNeedle 4-35 Tubing system, Single-Needle ONLINEplus™ 7-14 Tubing system, Single-Needle with rinse solution bag 7-16 Tubing systems 8-2 Tubing systems (description) 7-10
Technical safety checks 11-1, 13-3
U
Single-Needle pump segment 7-15, 7-17
Technical safety checks / maintenance procedures 11-1
UF menu 4-3, 4-41, 4-42, 4-60, 4-90
Technician's card 13-2
UF parameters 4-40, 4-60
Single-Needle specifications 12-18
Terms 13-1
UF profiles 4-41, 4-60
Therapy restrictions 2-5
UF timer I/O (button) 3-21
Thumb rest of syringe plunger 7-18
UFC measurement 12-10
Single-Needle pressure port 3-11 Single-Needle pump 3-11
Single-Needle, description 14-1 SN hydrophobic filter (WET) (User setup) 4-86 Specification of use 2-4 Specifications 12-1 Start-up screen 3-19 Status (button) 3-20 Status bar 3-20, 4-47, 4-51, 4-52, 4-57 Stock (heparin pump) 3-13
Tilt hazard 2-12, 10-1 Time (User setup) 4-74
Ultrafiltration (specifications) 12-10
Timer 4-75
Ultrafiltration (User setup) 4-84
Tips (significance) 2-2
User card 13-2
Top tray 14-53
User interface 3-19, 4-88
Traffic light (operating status indicator) 3-7
UserCard 3-10, 13-2
Storage 10-3
Transmembrane pressure 12-10, 13-2
Storage conditions 10-3, 12-6
Transport 10-3
Strap for disinfectant container 3-16
Transport / storage 10-1
Stroke volume 12-18
Treatment 4-45
Substituate connector (SafeLine™) 7-11, 7-15
Treatment data sheet 3-21
Substituate port catch (blue) 3-12 Substituate pump 3-11 Substitution (User setup) 4-96 Suction tube flap 3-15 Surface cleaning 6-19, 8-3 Surface disinfection 6-19 Switching off (hemodialysis system) 6-20
Fresenius Medical Care
Tray for disinfectant container 3-16 Treatment course 3-23
Substituate port 3-12
5008S
Ultrafiltration 7-18
Treatment, observe before and during 4-11 TSC 13-3 Tube guide 3-13 Tube roller 3-13 Tubing system, Double-Needle with rinse solution bag 7-12 Tubing system, removing 4-71 Tubing system, setup with ONLINE 4-18
IFU-EN
User setup 4-77, 4-78, 13-2
V VAM 5-22 VAM description 5-22 Ven. hydrophobic filter (WET) (User setup) 4-87 VenAcc 14-5 VenAcc description 14-6 VenAcc operation 14-8 VenAcc specifications 12-18 VenAcc surface cleaning 6-20 VenAcc User setup 4-103 Venous bubble catcher 7-11, 7-13, 7-15, 7-17 Venous bubble catcher, how to insert 4-19, 4-25, 4-31, 4-36
1-5
Chapter 1: Index
Venous insertion site / sampling site 7-10, 7-12, 7-14, 7-16 Venous measuring head (BTM) 3-12 Venous monitoring function 3-12, 3-14 Venous occlusion clamp 3-12 Venous patient line 7-11, 7-13, 7-15, 7-17 Venous pressure 3-21 Venous pressure alarm 5-18 Venous pressure line 7-11, 7-12, 7-14, 7-16 Venous pressure measurement 12-14 Venous pressure port 3-12 Venous tubing system 7-11, 7-13, 7-15, 7-17 Venous tubing system connector 7-10, 7-12, 7-14, 7-16 Venous tubing system, changing 4-114
W Warning 5-5 Warnings 2-8 Warnings (significance) 2-2 Warnings, consumables and accessories 2-16 Warnings, electrical 2-14 Warnings, hygiene 2-8 Warnings, system-specific 2-12 Warnings, therapy 2-9 Water alarms 13-2 Water supply (dialysis water) inlet 3-16 Weekly programs (User setup) 4-93 Weight (hemodialysis system) 12-1 WET 5-20 WET description 5-21 WET User setup "Alarm processing" (SN hydrophobic filter) 4-86 WET User setup "Alarm processing" (ven. hydrophobic filter) 4-87
1-6
Fresenius Medical Care 5008S IFU-EN
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 contains 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.
Styles used in the document
The following text styles may be used in the document: Style
Description
Keys and buttons
Keys and buttons on the device are shown in bold type. Example: Example key.
Message text
Messages displayed by the device are shown in italic type. Example: Message: Example of a message.
Instruction
Instructions are indicated by an arrow . Instructions must be followed. Example: Carry out instruction.
1. Numbered Instruction 2. ... 3. ... Illustrations
Fresenius Medical Care
Long passages containing instructions can be shown as numbered lists. Instructions must be followed. Example: 1. Carry out instruction.
The illustrations used in the documents may differ from the original if this does not have any influence on the function.
5008S
IFU-EN
11A-2015
2-1
Chapter 2: Important information
Importance of the Instructions for Use
This Instructions for Use is part of the accompanying documents and are an essential part of the device. It contains all information required for operating the device. The Instructions for Use must be carefully studied before attempting to operate the device.
2.2
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.
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 result in the following: – Damage to the device – Required functions will not be executed at all or not executed correctly
2.4
Significance of tips Tip Information providing useful tips for easy handling.
2-2
Fresenius Medical Care
5008S
IFU-EN
11A-2015
Chapter 2: Important information
2.5
Brief description The hemodialysis system enables treatments to be performed without the need for additional equipment. The hemodialysis system controls and monitors the dialysate circuit and the extracorporeal blood circuit. By default, the hemodialysis system is configured for treatments using the ONLINE procedures. In this case, the AutoSub plus function automatically optimizes the volume of the substitution fluid. There are four keys on the monitor. All entries are made via a high-resolution color monitor (touch screen). The current treatment data is shown on the display. In the dialysate circuit, dialysis 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 depends on the ultrafiltration rate selected and the type of dialyzer used. In the extracorporeal blood circuit, blood passes through the dialyzer. 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. Arterial pressure monitoring detects suction of the needle to the vessel wall of the patient's vascular access. 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, depending on the blood flow rate. The hemodialysis system employs the latest technology in its field. It is equipped with all the necessary safety systems, both for operational reliability and for patient safety. It complies with the requirements of EN 60601-1:2005 (IEC 60101-1:2005). The hemodialysis system is classified as class II b equipment (MDD). Among other things, the hemodialysis system uses "Free Software". For further information, refer to the appropriate chapter (see Chapter 15.1 on page 15-1).
Fresenius Medical Care
5008S
IFU-EN
11A-2015
2-3