Fresenius Medical
5008 Hemodialysis System Instructions for Use Part no F40003104 Sw ver 4.58 Edition 11A-2015
Instructions for Use
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5008 Hemodialysis system Instructions for Use Software version: 4.58 Edition: 11A-2015 Part no.: F40003104 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... 3-7 Monitor front ... 3-8 Monitor rear ... 3-11
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4
3.1.7 3.1.8 3.1.9 3.1.10
Extracorporeal Blood Circuit Module ... 3-12 Hydraulics ... 3-16 Hydraulics connectors ... 3-17 External connection options... 3-18
3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5
User interface... 3-21 After switching on the device ... 3-21 Overview (screen)... 3-22 General operating concept ... 3-24 Examples for data entry (treatment data) ... 3-27 Screen saver... 3-29
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
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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 ... 4-85 4.6.2.7 Alarm processing... 4-86 4.6.2.8 User interface ... 4-89 4.6.2.9 Cleaning ... 4-92 4.6.2.10 Auto On ... 4-93 4.6.2.11 Emergency (response after pressing the Emergency button) ... 4-96 4.6.2.12 Extended safety ... 4-96 4.6.2.13 ONLINE ... 4-97 4.6.2.14 OCM ... 4-100 4.6.2.15 Single-Needle (can only be selected if the device option exists) ... 4-101 4.6.2.16 Miscellaneous ... 4-101 4.6.2.17 BPM (can only be selected if the device option exists) ... 4-102 4.6.2.18 BTM (can only be selected if the device option exists) ... 4-103 4.6.2.19 VenAcc (can only be selected if the device option is available) ... 4-104 4.6.2.20 HD-PAED (can only be selected if the device option exists)... 4-104 4.6.2.21 BVM (can only be selected if the device option exists) ... 4-105
4.7 4.7.1 4.7.2
Applications ... 4-107 APPLICATIONS – selecting / setting... 4-107 APPLICATIONS – overview ... 4-108 4.7.2.1 Create PatientCard ... 4-108 4.7.2.2 Training ... 4-108 4.7.2.3 Fluid sampling using the sampling set for hygiene tests ... 4-109
4.8 4.8.1
Other functions... 4-111 PatientCard... 4-111 4.8.1.1 Loading the treatment parameters ... 4-111 4.8.1.2 Saving the treatment parameters ... 4-111 Emergency button ... 4-112 Emptying / changing the bibag® ... 4-113 Changing filter 1 / filter 2... 4-113 Cleaning the dialysis fluid particle filter... 4-115 Fluid sampling using the sampling valve (option)... 4-115 Removing lines during preparation... 4-115 Removing lines during treatment... 4-116 4.8.8.1 Changing the arterial tubing system... 4-116 4.8.8.2 Changing the venous tubing system ... 4-116 4.8.8.3 Removing the SafeLine™ ... 4-116 4.8.8.4 SafeLine™ setup... 4-117 4.8.8.5 Removing all lines ... 4-117 Circulation... 4-118
4.8.2 4.8.3 4.8.4 4.8.5 4.8.6 4.8.7 4.8.8
4.8.9
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4.8.10 4.8.11 4.8.12 4.8.13
4.8.14
4.8.15
5
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Administering infusions... 4-118 Setting the level in the venous drip chamber... 4-119 Single-Needle Click-Clack ... 4-120 OCM (Online Clearance Monitoring) ... 4-123 4.8.13.1 Observe before use ... 4-123 4.8.13.2 Description ... 4-123 4.8.13.3 Menu overview ... 4-125 4.8.13.4 OCM chart ... 4-126 4.8.13.5 Checking / setting the OCM parameters ... 4-126 4.8.13.6 Stability criteria ... 4-127 4.8.13.7 Starting the OCM... 4-127 4.8.13.8 Stopping the OCM ... 4-127 ONLINEplus™ ... 4-129 4.8.14.1 Observe before use ... 4-129 4.8.14.2 Description ... 4-129 4.8.14.3 Menu overview ... 4-130 4.8.14.4 Preparation, treatment, reinfusion ... 4-131 4.8.14.5 AutoSub plus description... 4-131 4.8.14.6 Manual substitution description ... 4-131 Network... 4-133 4.8.15.1 Observe before use ... 4-133 4.8.15.2 DataXchange Panel ... 4-133
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 drip chamber ... 5-8
5.12
Microbubbles detected below the venous drip chamber... 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
WET (Wet Transducer Protector) ... 5-20 Observe before use ... 5-20 Description... 5-21
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5.16.3
Alarm processing... 5-21
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 container ... 6-4
6.4
Starting a cleaning program... 6-7
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 6.8.3
Endless rinse ... 6-15 Observe before use ... 6-15 Central disinfection ... 6-16 Central free rinse ... 6-17
6.9
Surface cleaning / surface disinfection... 6-18
6.10
Switching off the hemodialysis system ... 6-19
6.11
Changing filter 1 / filter 2 ... 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
Tubing systems (description) ... 7-12
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8
9
7.5.1 7.5.2 7.5.3 7.5.4 7.5.5
Tubing system, Double-Needle ONLINEplus™ ... 7-12 Tubing system, Double-Needle with rinse solution bag... 7-14 Tubing system, Single-Needle ONLINEplus™ ... 7-16 Tubing system, Single-Needle with rinse solution bag ... 7-18 MIXED HDF tubing system... 7-20
7.6
Heparin syringe... 7-22
7.7
Dialyzer connectors... 7-22
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
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10.1
Relocation ... 10-2
10.2
Transport ... 10-3
10.3 10.3.1
Storage ... 10-3 Storage conditions ... 10-3
10.4
Environmental compatibility / disposal ... 10-4
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10.4.1 10.4.2
Information for the responsible organization ... 10-4 Information for recycling and waste disposal services ... 10-4
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 ... 12-18
12.18
Radio (option) - in monitor ... 12-18
12.19
Single-Needle (option) ... 12-19
12.20
VenAcc (option) monitoring unit... 12-19
12.21
BPM (option) ... 12-19
12.22
BTM (option) ... 12-20
12.23
BVM (option) ... 12-21
12.24
Residual-current device* (option) ... 12-21
12.25
Materials used... 12-22
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13 Definitions 13.1
Definitions and terms ... 13-1
13.2
Abbreviations... 13-3
13.3
Symbols... 13-4
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 the 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 the blood pressure measurement... 14-25 14.3.11 Entering BPM data manually ... 14-26 14.3.12 Alarm processing (blood pressure / pulse) ... 14-26
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14.4 14.4.1 14.4.2 14.4.3 14.4.4
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
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 14.4.4.3 BTM events ... 14-32 Preparation ... 14-33 Recirculation... 14-34 Temperature control ... 14-35 Alarm processing... 14-35
14.5.5 14.5.6 14.5.7 14.5.8
BVM option (Blood Volume Monitor)... 14-37 Observe before use ... 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... 14-48
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 use ... 14-51 Description... 14-51 Menu overview ... 14-52 Chart... 14-52 Preparation, treatment, reinfusion ... 14-53 Setting up the extracorporeal blood circuit ... 14-54 Changing from MIXED HDF to Single-Needle... 14-57
14.7 14.7.1 14.7.2 14.7.3 14.7.4
Option HD-PAED... 14-59 Observe before use ... 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 ... 14-62 14.7.4.3 Changing from Pediatric mode to Standard mode ... 14-63 14.7.4.4 Changing from Standard mode to Pediatric mode ... 14-63 14.7.4.5 Setting the level... 14-64
14.8 14.8.1 14.8.2 14.8.3 14.8.4
Top tray option ... 14-65 Specification of use ... 14-65 Observe before use ... 14-65 Description... 14-65 Operation... 14-66
14.9 14.9.1 14.9.2 14.9.3 14.9.4 14.9.5
Residual-current device option* ... 14-67 Specification of use ... 14-67 Observe before use ... 14-67 Description... 14-67 Operation... 14-68 Testing interval for RCD ... 14-69
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15 Appendix 15.1
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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™) 7-13, 7-17
Audible info 6-11
Body temperature control 12-20
Auto Off 6-11
BPM 14-15
Auto On 4-93
BPM (User setup) 4-102
AutoFlow 12-12
BPM blood pressure cuffs 3-2, 14-17
Auto-Single-Needle 12-19
Additional optional equipment 2-17
AutoSub plus 4-131
BPM data, entering manually 14-26
Air bubble detector 3-15, 12-14
B
BPM description 14-16
Air removal 5-9
Barrel holder with syringe detector 3-14
Addresses 2-18
Alarm 5-5
Battery 9-3, 10-3, 10-4, 12-6, 12-19, 12-24
Alarm mute 13-6 Alarm output 3-19, 13-5
bibag® 4-8, 4-70, 7-10
Alarm processing 4-86, 5-1
bibag® port 3-16
Anticoagulation 4-80
bibag®, connecting 4-8
Appendix 15-1
bibag®, emptying / changing 4-113
Applications 4-107 AquaUNO / AquaC UNO H 2-17, 3-19, 12-7, 13-5
Bicarbonate dialysis 4-8, 13-1 Bicarbonate flap 3-16
Arterial insertion site / sampling site 7-12, 7-14, 7-16, 7-18 Arterial line guide 7-12, 7-14, 7-16, 7-18 Arterial measuring head (BTM) 3-13
BPM operation 14-18 BPM pressure port 3-2 BPM pressure tubing 3-2 BPM specifications 12-19 Bracket (heparin pump) 3-14 Brake 3-2 Brief description 2-3 BTM 14-27 BTM (arterial measuring head) 3-13 BTM (User setup) 4-103
Bicarbonate suction tube (blue) 3-16
BTM (venous measuring head) 3-13
Bld. press. (display / button) (BPM) 3-23
BTM description 14-28 BTM design 3-13
BLK 5-19
BTM Extracorporeal Blood Circuit 7-4, 7-5
Arterial occlusion clamp 3-12
BLK description 5-19
Arterial patient line 7-12, 7-14, 7-16, 7-18
BLK User setup "Extended safety" Kinking (BLK) 4-96
BTM specifications 12-20
Arterial pressure 3-23
Blood alarms 7-3, 13-1
BTM surface cleaning 6-19
Arterial pressure dome 4-18, 4-24, 4-31, 4-36, 7-12, 7-14, 7-16, 7-18
Blood flow 7-22
BVM 14-37
Blood flow (display / button) 3-23
BVM basic control 14-39
BTM operation 14-29
Arterial pressure measurement unit 3-12, 4-15, 4-18, 4-24, 4-31, 4-36, 7-2
Blood inlet of the dialyzer 7-22
BVM description 14-38
Blood leak 5-24
BVM design 3-13
Arterial pressure measurement unit, opening manually 5-29
Blood leak detector 12-10 Blood line kinking (BLK) 5-19
BVM Extracorporeal Blood Circuit 7-4, 7-5
Arterial pump segment 7-12, 7-14, 7-16, 7-18 Arterial tubing system 7-12, 7-14, 7-16, 7-18 Arterial tubing system connector 7-12, 7-14, 7-16, 7-18 Arterial tubing system, changing 4-116
BVM measuring head 3-13
Blood pressure cuff (BPM) 3-2, 14-17
BVM specifications 12-21
Blood Pressure Monitor (BPM) 14-15
BVM operation 14-42 BVM surface cleaning 6-19 BVM User setup 4-105
Blood pressure monitor (BPM) 12-20 Blood pump 3-12, 3-14, 4-78 BLOOD SYSTEM menu 4-1
Audible alarm 12-15
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Chapter 1: Index
C
Current messages 3-22
Card for use for patient for Treatment data documentation 13-2
Disinfectant container, connecting 6-4
D
Disinfectant indicators 8-3
Card slot 3-11
Data entry, examples (treatment data) 3-27
Central Delivery System (CDS) 4-10
DataXchange Panel 4-133
Certificates 13-8
DataXchange Panel operation 4-134
Changing filter1 / filter2 4-113
Define options 4-90
Changing settings with the number buttons (example) 3-27
Definitions 13-1
Changing settings with the rocker switch button (input example) 3-28 Chart time scale (User setup) 4-74 Check for residual disinfectant 6-12 Circulation 4-118 Cleaning / disinfection 6-1 Cleaning programs 12-9 Collection bag 7-15, 7-19 Concentrate flap 3-16 Concentrate rack 3-2, 4-8 Concentrate suction tube (red) 3-16 Concentrates 4-7, 9-5, 12-11 Conductivity 13-2 Conductivity alarm 5-25 Connection, venous pressure line 7-13, 7-15, 7-17, 7-19 Connector for Bic, blue 3-17 Connector for CDS 1, red 3-17 Connector for CDS 2, red 3-17 Connector on Single-Needle chamber (Luer lock) 7-17, 7-19
Disposal 10-4 Double-Needle 4-16, 4-17, 4-24, 4-46, 4-47, 4-51, 4-64, 4-65, 4-67 Double-Needle ONLINEplus™ tubing system 7-12 Drain 3-17 Drip chamber (venous) 4-19, 4-25, 4-31, 4-36, 7-13, 7-15, 7-17, 7-19
Definitions and terms 13-1
Drip champer 13-1
Degreasing 8-3
Duties of the responsible organization 2-6
Descaling 8-3 Design 3-1 Dialysate flow 7-22, 12-12
E
Dialysate flow (display) 3-22
EBC 13-3
Dialysate inlet port 7-22
EBM 13-3
Dialysate inlet tube 3-4, 7-22
EcoFlow 4-10, 12-12
Dialysate lines 3-4, 4-22, 4-27, 4-33, 4-38
Electrical power supply 12-2
Dialysate menu 4-3, 4-40, 4-42, 4-60, 4-70, 4-91, 4-113
Electrical safety 12-2 Electromagnetic compatibility 12-3
Dialysate outlet port 7-22
Electromagnetic compatibility (EMC) 13-3
Dialysate outlet tube 3-4, 7-22
EMC 12-3, 13-3
Dialysate parameters 4-40, 4-60
Emergency 4-96
Dialysate temperature 12-11
Emergency button 3-23, 4-96, 4-112
Dialysis fluid particle filter, cleaning 4-115
Emergency operation handle 3-14
Dialysis water 3-17, 13-1, 13-2
Emptying the dialyzer 4-70
Dialyzer 7-12, 7-14, 7-16, 7-18
Endless rinse (cleaning / disinfection) 6-2, 6-15
Dialyzer connectors 7-22 Dialyzer coupling, inlet 7-22 Dialyzer coupling, outlet 7-22
Environmental compatibility / disposal 10-4
Dialyzer couplings 3-5
Equipotential bonding 3-17, 9-2
Connector on venous drip chamber (Luer lock) 7-13, 7-15, 7-17, 7-19
Dialyzer holder 3-4, 3-5
Expected service life 2-6
Dialyzers 8-1
Connector post-dilution 7-13, 7-17
DIASAFE®plus 3-4, 8-2, 12-15
External connection options 3-7, 3-18, 12-7
Connector pre-dilution 7-13, 7-17
DIASAFE®plus, changing 4-113
Considerations for working on the device 2-5
Dimensions 12-1
Consumables, accessories, additional equipment 8-1 Consumption data / energetic data 12-5 Contraindications 2-4 Create PatientCard 4-108
1-2
Extracorporeal Blood Circuit Module (EBM) 3-1, 3-12, 4-18, 4-24, 4-30, 4-35, 13-3, 14-54
Disclaimer of liability 2-8 Disinfectant 8-3 Disinfectant connector, black 3-17
F
Disinfectant connector, yellow 3-17
Filter 1 – DIASAFE®plus 7-4
Disinfectant container (strap) 3-17
Filter 2 – DIASAFE®plus 3-4, 7-4
Fan filter (service door) 3-7
Filter chamber 3-4
Fresenius Medical Care 5008 IFU-EN
Chapter 1: Index
How to use the Instructions for Use 2-1
Levers of the spring clip (heparin pump) 3-14
Hydraulics 3-1, 3-7, 3-16, 3-17
Line guide 3-14
Flow chart 7-8
Hydraulics connectors 3-7, 3-17
Line holder (for transport) 3-7
Fluid sampling using the sampling set for hygiene tests 4-109
Hydrophobic filter in the SingleNeedle pressure line 7-17, 7-19
Line holder for the SafeLine™ 3-13
Fluid sampling using the sampling valve (option) 4-115
Hydrophobic filter in the venous pressure line 7-13, 7-14, 7-16, 7-18
Line holders 3-12
Filter chamber door 3-4 Filter change (filter1 / filter2) 4-113 Flow alarm 12-13
Flush 12-9 Flush drain 3-17 Food intake 14-44
I
Free software 2-3, 15-1
Identification label 12-1
Front view 3-1
Important information 2-1
Functional description 7-1
Info 5-5
Fuses 12-3
Info (button) 3-23 Infusion 4-118 Infusions, administering 4-118
G
Initial start-up 9-6
General operating concept 3-24
Installation 9-1
Groove 3-13
Intended purpose 2-4 Intended use 2-4
H
Interaction with other systems 2-5
Handle for emergency operation 3-14
ISO UF 13-2 IV pole 3-4, 3-5
HD-PAED 4-104, 14-59 HD-PAED description 14-60 HD-PAED operation 14-61, 14-62
J Jaws of the spring clip (heparin pump) 3-14
HD-PAED User setup 4-78 Hemoconcentration 13-1 Hemodialysis concentrates 8-2
K
Hemodialysis system, switching off 6-19 Hemodialysis system, switching on 4-5 Heparin 4-12, 4-43
Lines, removing during preparation 4-115 Lines, removing during treatment 4-116 Loudness (audible alarm) 4-74 Loudspeaker 3-11 Luer lock connector on SingleNeedle chamber 7-17, 7-19 Luer lock connector on venous drip chamber 7-13, 7-15, 7-17, 7-19
M MA 13-3 Main power switch 3-7 Maintenance procedures 11-1, 13-3 Materials 12-22, 12-24 Materials used 12-22 Maximum total weight 12-1, 13-2 Medical electrical equipment 13-2 Menu bar 3-23 Menu panel 3-23 Menu structure, design 3-26
Kinking (BLK) (User setup) 4-96
Messages 5-5
Kinking / clotting 4-96, 5-19
Microbiology 9-4, 9-5
Kt/V 4-123
Microbubbles 5-12
Kt/V warning 4-100
Heparin (display) 3-23
Lines, removing all 4-117
Microbubbles, removal 5-15 Miscellaneous (User setup) 4-101
Heparin line 7-13, 7-15, 7-17, 7-19 HEPARIN menu 3-23, 4-4, 4-43 Heparin pump 2-16, 3-12, 3-14, 4-12, 7-2, 12-14
L
MIXED HDF 14-51
LAN (network) 3-19, 12-18, 13-5
MIXED HDF description 14-51
Leakage sensor, Extracorporeal Blood Circuit Module 3-13
MIXED HDF design 3-13
Heparin pump parameters 4-43, 4-61
Leakage sensor, filter chamber 3-4
MIXED HDF extracorporeal blood circuit 7-5
LED screen 10-4, 12-24
MIXED HDF operation 14-52
Heparin syringe 4-18, 4-25, 4-31, 4-36, 7-13, 7-15, 7-17, 7-19, 8-2, 14-55
LEDs / keys 3-8
MIXED HDF surface cleaning 6-18
Level detector 3-15, 7-2, 12-14
MIXED HDF tubing system 7-20
Level, setting the level in the venous drip chamber 4-119
MIXED HDF User setup 4-97
Holder for Single-Needle chamber 3-12
Fresenius Medical Care
5008
IFU-EN
Monitor 3-1, 3-8, 3-11
1-3
Chapter 1: Index
Monitor arm 3-11
Operator setup 13-2
Mute 3-9, 5-2, 13-5
Optical detector 3-15, 4-19, 4-25, 4-32, 4-37, 12-14, 14-55
N
Options 14-1
Na profiles 4-41, 4-60 Network 4-133 Network (LAN) 3-19, 4-133, 12-18, 13-5
Overflow (mixing chamber) 3-17
Notes (significance) 2-2
Particle filter, dialysis fluid 3-4
Number buttons (input example) 3-27
Patient ID 3-23, 4-134
O OCM 4-123 OCM (User setup) 4-100 OCM description 4-123
Rechargeable battery 10-4, 12-2, 12-24 Recirculation 14-28 Recirculation measurement 12-20 Recording treatments with control functions 12-20, 12-21
Patient, connecting with ONLINE 4-47
Recycling 10-4
Patient, connecting with ONLINE and Single-Needle 4-52
Relocation 10-2
Patient, disconnecting with ONLINE 4-65
Residual-current device 12-21
OCM operation 4-125
Patient, disconnecting with ONLINE and Single-Needle 4-69
OCM specifications 12-15
PatientCard 3-11, 13-2
ONLINE (bolus) 4-49, 4-55, 4-98
Reinfusion 4-63, 4-79 Residual disinfectant (check) 6-12 Responsible organization (duties) 2-6 Reverse osmosis unit (User setup) 4-101
ONLINE Priming Set 4-17
Performing a manual reinfusion. 5-28
ONLINEplus™ 4-129
Permeate 13-1, 13-2
ONLINEplus™ description 4-129
Power cable socket (power supply connection) 3-7
ONLINEplus™ design 3-12 ONLINEplus™ Extracorporeal Blood Circuit 7-4, 7-5 ONLINEplus™ operation 4-130
Reaction ven. window alarm 4-88, 5-18 Recessed grip 3-11
Overview (screen) 3-22
P
Radio, specifications 12-18
Rear view 3-7
Overflow (water inlet chamber) 3-17
Non-medical electrical equipment 13-2
R
Rinse / reinfusion volume (User setup) 4-79
Power failure (power outage) 5-26 Power failure and battery operation 5-26
Rinse connector 7-13, 7-17 Rinse port 3-13 Rinse port catch (gray) 3-13 Rinse solution bag 7-15, 7-19 RO 13-3 Rocker switch button (input example) 3-28
ONLINEplus™ specifications 12-16
Power failure and empty battery 5-26
ONLINEplus™ surface cleaning 6-18
Power supply connection 3-7
Rotor 3-14
ONLINEplus™ tubing system Single-Needle 7-16
Pre- / post-dilution connector (SafeLine™) 7-13, 7-17
S
Preparation 4-1, 12-8
Safe working load 12-1, 13-2
ONLINEplus™ User setup 4-97
PREPARATION menu 4-2
SafeLine™ 7-13, 7-17, 7-21
Opening the DataXchange Panel (User setup) 4-89
Pressure displays (display / button) 3-23
SafeLine™ line guide 7-13, 7-17
Operating conditions 12-4
Pressure holding test 12-10
SafeLine™ pump segment 7-13, 7-17
Operating mode (display) 3-22
Pressure tubing (BPM) 3-2, 14-17
SafeLine™, removing 4-116
Operating programs 12-8
Profiles 4-41, 4-60
SafeLine™, setup 4-117
Operating status indicator (traffic light) 3-8
Pulse 12-20
Sampling valve (option) 3-4
Pump housing 3-14
Operation 4-1
Screen 3-9, 3-22
Push handle 3-7
Screen colors 3-24
ONLINEplus™ tubing system 7-12
Operator card 13-2 Operator responsibility 2-7
1-4
Power outage (power failure) 5-26
Room temperature 4-104
Screen failure 5-27
Fresenius Medical Care 5008 IFU-EN
Chapter 1: Index
Screen failure – no screen response 5-27 Screen failure – screen dark or display distorted 5-27
Single-Needle, description 14-1
Tilt hazard 2-12, 10-1
SN hydrophobic filter (WET) (User setup) 4-87
Time (User setup) 4-74 Timer 4-75
Specification of use 2-4
Screen failure sensor 3-8
Tips (significance) 2-2
Specifications 12-1
Screen saver 3-29
Top tray 14-65
Start-up screen 3-21
Screen, cleaning 6-19
Status (button) 3-22
Traffic light (operating status indicator) 3-8
Selecting the concentrate supply 4-7
Status bar 3-22, 4-47, 4-51, 4-52, 4-57
Transmembrane pressure 12-10, 13-2
Selection screen 3-21
Stock (heparin pump) 3-14
Transport 10-3
Sequential therapy 13-2
Storage 10-3
Transport / storage 10-1
Service door 3-7
Storage conditions 10-3, 12-6
Tray for disinfectant container 3-17
Service life 2-6
Strap for disinfectant container 3-17
Treatment 4-45
Stroke volume 12-19
Treatment data sheet 3-23
Setting the venous alarm limit 4-14
Substituate connector (SafeLine™) 7-13, 7-17
Treatment, observe before and during 4-11
Setup 4-77
Substituate port 3-13
TSC 13-3
Shunt interlock 3-4
Substituate port catch (blue) 3-13
Shunt interlock flap 3-4, 3-5
Tube guide 3-14
Substituate pump 3-13
Tube roller 3-14
Side effects 2-4
Substitution (User setup) 4-97
Side view 3-2, 3-4
Surface cleaning 6-18, 8-3
Tubing system for MIXED HDF 7-20
Significance of notes 2-2
Surface disinfection 6-18
Significance of tips 2-2
Switching off (hemodialysis system) 6-19
Tubing system, removing 4-71
Switching on (hemodialysis system) 4-5
Tubing system, setup with ONLINE 4-18
Symbols 13-4
Tubing system, setup with ONLINE in case of Single-Needle 4-30
ServiceCard 3-11, 13-2 Setting the level in the SingleNeedle chamber 4-61
Significance of warnings 2-2 Single programs (User setup) 4-95 Single-Needle 3-12, 7-5, 13-2, 14-1 Single-Needle (User setup) 4-101
Symbols for consumables 13-7
Single-Needle chamber 7-17, 7-19, 12-19
Syringe barrel 7-22
Single-Needle Click-Clack 4-101, 4-120, 7-3, 12-15
Syringe wings 7-22 System installer 12-18
Single-Needle design 3-12
SYSTEM menu 4-73
Syringe plunger 7-22
Single-Needle line guide 7-17, 7-19
T
Single-Needle operation 14-2
Treatment course 3-25
Tubing system, Double-Needle with rinse solution bag 7-14
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™ 7-16 Tubing system, Single-Needle with rinse solution bag 7-18
Single-Needle pressure line 7-17, 7-19
T1 test 4-10, 12-8
Single-Needle pressure line connector 7-17, 7-19
Technical safety checks 11-1, 13-3
Tubing systems (description) 7-12
Single-Needle pressure port 3-12
Technical safety checks / maintenance procedures 11-1
U
Single-Needle pump 3-12 Single-Needle pump segment 7-17, 7-19 Single-Needle specifications 12-19
Fresenius Medical Care
5008
Target group 2-5
Technician's card 13-2 Terms 13-1
Tubing systems 8-2
UF menu 4-3, 4-41, 4-42, 4-60, 4-91
Therapy restrictions 2-5
UF parameters 4-40, 4-60
Thumb rest of syringe plunger 7-22
UF timer I/O (button) 3-23
IFU-EN
UF profiles 4-41, 4-60
1-5
Chapter 1: Index
UFC measurement 12-10
W
Ultrafiltration 7-22
Warning 5-5
Ultrafiltration (specifications) 12-10 Ultrafiltration (User setup) 4-85 User interface 3-21, 4-89 User setup 4-77, 13-2 UserCard 3-11, 13-2
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
V
Warnings, therapy 2-9
VAM 5-22
Water alarms 13-2
VAM description 5-22
Water supply (dialysis water) inlet 3-17
Ven. hydrophobic filter (WET) (User setup) 4-88 VenAcc 14-5 VenAcc description 14-6 VenAcc operation 14-8 VenAcc specifications 12-19 VenAcc surface cleaning 6-19 VenAcc User setup 4-104 Venous drip chamber 7-13, 7-15, 7-17, 7-19 Venous drip chamber, how to insert 4-19, 4-25, 4-31, 4-36 Venous insertion site / sampling site 7-12, 7-14, 7-16, 7-18
Weekly programs (User setup) 4-94 Weight (hemodialysis system) 12-1 WET 5-20 WET description 5-21 WET User setup "Alarm processing" (SN hydrophobic filter) 4-87 WET User setup "Alarm processing" (ven. hydrophobic filter) 4-88
Venous measuring head (BTM) 3-13 Venous monitoring function 3-13, 3-15 Venous occlusion clamp 3-13 Venous patient line 7-13, 7-15, 7-17, 7-19 Venous pressure 3-23 Venous pressure alarm 5-18 Venous pressure line 7-13, 7-14, 7-16, 7-18 Venous pressure measurement 12-14 Venous pressure port 3-13 Venous tubing system 7-13, 7-15, 7-17, 7-19 Venous tubing system connector 7-12, 7-14, 7-16, 7-18 Venous tubing system, changing 4-116 Volume corridor control (BVM) 14-40
1-6
Fresenius Medical Care 5008 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.
5008
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
5008
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 highresolution 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 the occlusion of the access line, e.g., by 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
5008
IFU-EN
11A-2015
2-3