5008S Hemodialysis System Instructions for Use Part no M56 073 1 Sw ver 4.57 Edition 10B-2015

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 Specification of use ... 2-4 Side effects... 2-4 Contraindications... 2-4 Therapy 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... 2-11 Warnings, electrical ... 2-14 Warnings, consumables and accessories ... 2-16

2.12

Additional optional equipment supplied by Fresenius Medical Care... 2-17

2.13

Addresses ... 2-18

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... 4-31 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 ... 4-52 Changing the UF parameters ... 4-52 Sodium and UF profiles ... 4-52 Changing the heparin pump parameters ... 4-53 Single-Needle ... 4-53 Reinfusion ... 4-55 REINFUSION menu... 4-55 Disconnect the patient ... 4-56 4.3.2.1 Disconnecting the patient – Double-Needle treatment using ONLINEplus™... 4-57 4.3.2.2 Disconnecting the patient – Double-Needle treatment using a rinse solution bag ... 4-59 Emptying the dialyzer ... 4-61 Emptying the bibag® ... 4-61 Removing the tubing system ... 4-61

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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... 4-63 SYSTEM menu settings ... 4-63 4.4.1.1 SYSTEM menu ... 4-63 4.4.1.2 Selecting the SYSTEM menu... 4-63 4.4.1.3 Adjusting the settings in the SYSTEM menu... 4-63 4.4.1.4 SYSTEM menu overview ... 4-64 Service... 4-65 User setup ... 4-65 4.4.3.1 Selecting the User setup ... 4-65 4.4.3.2 User setup (screen overview)... 4-65 4.4.3.3 Adjusting the settings in the User setup ... 4-65 4.4.3.4 User setup (overview) ... 4-66 Applications ... 4-99 4.4.4.1 Selecting applications ... 4-99 4.4.4.2 Adjusting the Applications settings... 4-99 4.4.4.3 Applications overview... 4-99 PatientCard... 4-102 4.4.5.1 Uploading the treatment parameters... 4-102 4.4.5.2 Saving the treatment parameters ... 4-102 Emergency button ... 4-103 Emptying / changing the bibag® ... 4-103 Changing the DIASAFE® plus ... 4-104 Cleaning the dialysate particle filter... 4-106 Performing a fluid sampling ... 4-106 Removing lines during preparation... 4-106 Removing lines during treatment... 4-106 4.4.12.1 Changing the arterial line ... 4-106 4.4.12.2 Changing the venous line... 4-107 4.4.12.3 Removing the SafeLine™ ... 4-107 4.4.12.4 Inserting / retrofitting the SafeLine™... 4-108 4.4.12.5 Removing all lines ... 4-108 Circulation... 4-108 Administering infusion solutions ... 4-109 Setting the level in the venous bubble catcher ... 4-110 Single-Needle Click-Clack ... 4-111 OCM (Online Clearance Monitoring) ... 4-113 4.4.17.1 Observe before use... 4-113 4.4.17.2 Description ... 4-113 4.4.17.3 Menu overview ... 4-115 4.4.17.4 OCM chart ... 4-116 4.4.17.5 Checking / setting the OCM parameters ... 4-116 4.4.17.6 Stability criteria ... 4-117 4.4.17.7 Starting the OCM ... 4-117 4.4.17.8 Stopping the OCM... 4-117 ONLINEplus™ ... 4-119 4.4.18.1 Observe before use... 4-119 4.4.18.2 Description ... 4-119 4.4.18.3 Menu overview ... 4-120 4.4.18.4 Preparation, treatment, reinfusion ... 4-121 4.4.18.5 Description AutoSub plus ... 4-121 Network ... 4-123 4.4.19.1 Observe before use... 4-123 4.4.19.2 DataXchange Panel ... 4-123

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5

6

vi

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 use ... 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 use ... 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 use ... 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

Arterial pressure measurement unit, opening manually ... 5-24

Cleaning / disinfection 6.1

Observe before use ... 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 ... 6-11

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

Endless rinse ... 6-16 Observe before use ... 6-16 Central disinfection ... 6-16

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8

9

6.8.3

Central free rinse ... 6-18

6.9

Surface cleaning / surface disinfection... 6-19

6.10

Switching off the hemodialysis system ... 6-21

6.11

Filter change ... 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 7.5.3 7.5.4

Tubing systems (description) ... 7-10 Tubing system ONLINEplus™ ... 7-10 Tubing system with rinse solution bag... 7-12 Tubing system ONLINEplus™ Single-Needle ... 7-14 Tubing system, Single-Needle with rinse solution bag ... 7-16

7.6

Dialyzer connectors ... 7-18

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 Dialysate... 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 ... 10-4

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

Materials used... 12-19

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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 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... 14-10 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

Option BPM (Blood Pressure Monitoring) ... 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... 14-22 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) ... 14-23 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

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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 14.5.5

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

Option BTM (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 ... 14-33 Temperature control ... 14-34 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 Screen saver (HOME-HD) overview... 14-41 Screen colors... 14-43 Screen saver (HOME-HD) description... 14-44 General operating concept - screen saver (HOME-HD) ... 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 ... 14-47 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 ... 14-48 14.5.11.8Starting / stopping the blood pressure measurement... 14-49 Charging the remote control battery ... 14-49 Other functions ... 14-50 14.5.13.1Emergency button (Remote control) ... 14-50 14.5.13.2Battery test (remote control) ... 14-50 14.5.13.3Self-test (remote control) ... 14-51 Alarm processing ... 14-51

15 Appendix 15.1

x

Notes on the use of “Free software” ... 15-1

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Chapter 1: Index

1

Index

A

AutoSub plus 4-121

BPM operation 14-18 BPM pressure port 3-12

Abbreviations 13-2 Acetate dialysis 4-9

B

BPM pressure tubing 14-17

Additional optional equipment 2-17

Barrel holder with syringe detector 3-10

BPM User setup 4-96

Addresses 2-18

Battery 9-3, 10-3, 12-6

Bracket (heparin pump) 3-10

Air bubble detector 3-11, 12-13

bibag® 4-8, 4-61, 7-8

Brake 3-3, 3-4

Air removal 5-6

bibag® flap 3-14

Brief description 2-3

Alarm 5-2

bibag® port 3-14

BTM 14-27

Alarm limits, monitoring (arterial / venous) 5-15

bibag®, connecting 4-8

BTM (arterial measuring head) 3-12

Alarm output (nurse call) 3-16, 13-5

bibag®, emptying / changing 4-103 Bibliography 13-8

Alarm override 12-8

Bicarbonate dialysis 4-8

Alarm processing 4-81, 5-1 Anticoagulation 4-68

Bicarbonate suction tube (blue) 3-14

Appendix 14-1, 15-1

Bld. press. (display / button) 3-19

Applications 4-99

BLK 5-16

AquaUNO / AquaC UNO H 3-16, 12-7, 13-5

BLK description 5-16

Arterial insertion site / sampling site 7-10, 7-12, 7-14, 7-16

BLK User setup "Extended safety" Kinking (BLK) 4-90

Arterial line, changing 4-106

Blood alarms 7-3, 13-1

Arterial measuring head (BTM) 3-12 Arterial occlusion clamp 3-8 Arterial patient line 7-10, 7-12, 7-14, 7-16 Arterial pressure 3-19 Arterial pressure dome 4-17, 4-22, 4-27, 4-32, 7-10, 7-12, 7-14, 7-16 Arterial pressure measurement unit 3-8, 4-11, 4-17, 4-22, 4-27, 4-32, 7-2 Arterial tubing system 7-10, 7-12, 7-14, 7-16 Arterial tubing system connector 7-10, 7-12, 7-14, 7-16 Audible alarm 12-14

BLK operation 5-16

BTM (venous measuring head) 3-12 BTM description 14-28 BTM design 3-12 BTM Extracorporeal Blood Circuit 7-4, 7-5 BTM operation 14-29 BTM specifications 12-17 BTM surface cleaning 6-20 BTM User setup 4-97 Bubble catcher 13-1

Blood flow 7-18

C

Blood flow (display / button) 3-19

Card slot 3-7

Blood inlet of the dialyzer 7-18 Blood leak 5-19

Central Delivery System (CDS) 4-9

Blood leak detector 12-10

Certificates 13-9

Blood outlet of the dialyzer 7-18 Blood pressure 12-17

Changing settings with the rocker switch button 3-24

Blood pressure cuff 3-12

Chart time scale 4-64

Blood pressure cuffs 14-17

Check for residual disinfectant 6-13

Blood pressure measurement 14-15 Blood pump 3-8, 3-10, 4-66 Body temperature control 12-18 BPM 14-15 BPM blood pressure cuffs 14-17

Audible info 6-12

BPM specifications 12-17

Auto Off 6-12

BPM data, entering manually 14-25

Auto On 4-87

BPM description 14-16

AutoFlow 12-11

BPM design 3-12

Circulation 4-108 Clamping brackets (heparin pump) 3-10 Cleaning / disinfection 6-1 Cleaning program 6-6, 6-11 Cleaning programs 12-9 Collection bag 7-13, 7-17 Concentrate container holder 3-3, 3-4

Auto-Single-Needle 12-16

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Chapter 1: Index

Concentrate suction tube (red) 3-14 Concentrates 4-7, 12-11

Dialyzer 7-10, 7-12, 7-14, 7-16 Dialyzer connectors 7-18 Dialyzer coupling, inlet 7-18

Conductivity 13-1

Dialyzer coupling, outlet 7-18

Conductivity alarm 5-20

Dialyzer couplings 3-5

Connection, SN pressure line 7-15, 7-17

Dialyzer holder 3-4, 3-5

Connection, venous pressure line 7-11, 7-12, 7-14, 7-16 Connector for CDS 1, red 3-15 Connector for CDS 2, red 3-15 Connector postdilution 7-11, 7-15

Dialyzer, emptying 4-61 Dialyzers 8-1 DIASAFE®plus 8-2, 12-15 DIASAFE®plus, changing 4-104 Dimensions 12-1 Disclaimer of liability 2-7

Connector pre- / postdilution (SafeLine™) 7-11, 7-15

Disinfectant 8-3

Connector predilution 7-11, 7-15

Disinfectant canister, connecting 6-4

Consumables, accessories, additional equipment 8-1

Disinfectant connector, black 3-15

Extracorporeal Blood Circuit Module (EBM) 3-1, 3-8, 3-12, 4-15, 4-16, 4-17, 4-21, 4-24, 4-26, 4-30, 4-34

F Fan filter 3-2 Fields of application 2-4 Filter 1 – DIASAFE®plus 7-4 Filter 1 – ONLINEplus™ 3-2 Filter 2 – DIASAFE®plus 7-4 Filter 2 – ONLINEplus™ 3-2 Filter change 4-104 Fixation for the plunger (heparin pump) 3-10 Flow alarm 12-12 Flow chart 7-6

Consumption data / energetic data 12-5

Disinfectant connector, yellow 3-15

Fluid sampling 4-100, 4-106

Contraindications 2-4

Disinfectant indicators 8-3

Flush 12-9

Cuff holder 3-12

Disposal 10-4

Flush drain 3-15

Current messages 3-18

Double-Needle 4-5, 4-40, 4-41, 4-44, 4-56, 4-57, 4-59

Free software 2-3, 15-1 Front view 3-1

D

Drain 3-15

Functional description 7-1

Data entry, examples (treatment data) 3-23

E

DataXchange Panel 4-123

EBC 13-3

G

Define options 4-84

EBM 13-3

General operation philosophy 3-20

Definitions 13-1

EcoFlow 4-35, 12-12

Grip handle (heparin pump) 3-10

Definitions and terms 13-1

Electrical safety 12-2

Groove 3-8

Degreasing 8-3

Electrical supply 12-2

Descaling 8-3

Electromagnetic compatibility (EMC) 12-3, 13-3

Design 3-1 Dialysate 9-4 Dialysate flow 7-18, 12-11 Dialysate flow (display) 3-18 Dialysate inlet 7-18 Dialysate inlet tube 3-4, 7-18 Dialysate lines 3-4, 4-20, 4-24, 4-29, 4-33 Dialysate outlet 7-18 Dialysate outlet tube 3-4, 7-18 Dialysate parameters 4-35, 4-52 Dialysate temperature 12-11 Dialysis fluid particle filter, cleaning 4-106

Fuses 12-3

EMC 12-3, 13-3 Emergency 4-90 Emergency button 3-19, 4-90, 4-103, 14-50 Emergency operation 5-21, 5-22 Endless rinse 6-16 Environmental compatibility / disposal 10-4 Equipotential bonding connection 3-15 Expected service life 2-5 External connection options 3-2, 3-16, 12-7

H Handle 5-21, 5-22 Handle for emergency operation 3-10 Hemoconcentration 13-1 Hemodialysis concentrates 8-2 Hemodialysis system, switching off 6-21 Hemodialysis system, switching on 4-5 Heparin (display) 3-19 Heparin (menu) 4-38 Heparin line 7-11, 7-13, 7-15, 7-17 Heparin menu 3-19

Dialysis water 9-3, 13-1

1-2

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Heparin pump 3-9, 3-10, 7-2, 12-14

Kinking / clotting 4-90, 5-16

Miscellaneous 4-95

Heparin pump parameters 4-38, 4-53

Kt/V 4-113

Monitor 3-1, 3-6, 3-7

Kt/V warning 4-94

Monitor arm 3-7

Heparin syringe 4-18, 4-23, 4-27, 4-32, 7-11, 7-13, 7-15, 7-17, 8-2 Holder for SN chamber 3-12 HOME-HD 14-37 HOME-HD description 14-37 Home-HD User setup 4-98 Home-HD, battery charging station 3-13 HOME-HD, design 3-13 HOME-HD, operation 14-39 HOME-HD, remote control 3-13, 14-38 How to use the Instructions for Use 2-1 Hydraulics 3-1, 3-2, 3-14, 3-15 Hydraulics connectors 3-2, 3-15

Mute 12-8

L LAN (network) 3-16, 12-16, 13-5, 14-5

N

Lateral view 3-3, 3-4

Network (LAN) 3-16, 4-123, 12-16, 13-5

Leakage sensor flap, hydraulics 3-15

Network 4-123

Note symbol, significance 2-2

Leakage sensor, Extracorporeal Blood Circuit Module 3-8

Numeric keypad 3-23

Leakage sensor, hydraulics 3-15

O

LEDs / buttons 3-6 Level detector 3-11, 12-13 Level, setting level in SN chamber 4-53

OCM 4-113 OCM description 4-113 OCM operation 4-115

Line guide 3-10, 7-10, 7-12, 7-14, 7-16

OCM specifications 12-15 OCM User setup 4-94

Hydrophobic filter in the SN pressure line 7-15, 7-17

Line holder for the SafeLine™ 3-9

ONLINE (bolus) 4-43, 4-48, 4-92

Line holders 3-8

ONLINE preparation 4-17

Hydrophobic filter in the venous pressure line 7-10, 7-12, 7-14, 7-16

Line pulley 3-10

ONLINE Priming Set 4-16

Line roller 3-10

ONLINEplus™ 4-17, 4-41, 4-56, 4-119

Lines, removing all 4-108

ONLINEplus™ description 4-119

Lines, removing during preparation 4-106

ONLINEplus™ design 3-8

Lines, removing during treatment 4-106

ONLINEplus™ Extracorporeal Blood Circuit 7-4, 7-5

Loudness (audible alarm) 4-64

ONLINEplus™ operation 4-120

Loudspeaker 3-7

ONLINEplus™ specifications 12-15

Info (button) 3-19

M

Infusion solution 4-109

Mains failure (power failure) 5-20

ONLINEplus™ surface cleaning 6-19

Infusion solutions, administering 4-109

Manufacturer's declaration on EMC 12-3

I Identification label 12-1 Important information 2-1 In the DIALYSATE MENU 4-35, 4-37 Info 5-2

Initial start-up 9-1

Materials 12-19, 12-21

Installation 9-1

Materials used 12-19

Intended purpose 2-4

Maximum total weight 12-1, 13-2

Intended use 2-4

Menu bar 3-19

Interaction with other systems 2-5

Menu panel 3-19

ISO UF 13-1

Menu structure, design 3-22

ISO UF (Sequential therapy) 12-8

Messages 5-2

IV pole 3-4, 3-5

Micro bubbles 5-9 Micro bubbles removal 5-12 Micro bubbles, overriding 5-11

K

Microbiology 9-4, 9-5

Kinking (BLK) 4-90

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ONLINEplus™ tubing system 7-10 ONLINEplus™ tubing system Single-Needle 7-14 ONLINEplus™ User setup 4-91 Operating conditions 12-4 Operating mode (display) 3-18 Operating programs 12-8 Operating status indicator 3-6 Operation 4-1 Operator card 13-2 Operator responsibility 2-6 Operator setup 13-2 Optical detector 3-11, 4-18, 4-23, 4-28, 4-33, 12-13

1-3

Chapter 1: Index

Override conditions 12-8 Overview (screen) 3-18

P Particle filter, dialysis fluid 3-2 Patient card 13-2 Patient ID 4-124 Patient ID (treatment data sheet) (display / button) 3-19 Patient, connecting with ONLINE 4-41 Patient, connecting with ONLINE and Single-Needle 4-45 Patient, disconnecting with ONLINE 4-57 Patient, disconnecting with ONLINE and Single-Needle 4-56 PatientCard 3-7, 4-99, 13-2 Potential equalization 9-2 Power connection (supply point) 3-2, 3-16

Recirculating adapter (SafeLine™) 7-11, 7-15

Setup 4-65

Recirculation 7-10, 14-28

Shunt interlock flap 3-4, 3-5

Recirculation measurement 12-17

Side effects 2-4

Recycling 10-4

Significance of tips 2-2

Reinfusion 4-55, 4-67 Relocation 10-1

Single-Needle 3-12, 7-5, 13-2, 14-1

Responsible organization (duties) 2-6

Single-Needle Click-Clack 4-95, 4-111, 7-3, 12-14

Rinse / reinfusion volume 4-67

Single-Needle design 3-12

Rinse connector 7-11, 7-15

Single-Needle operation 14-2

Rinse port 3-8

Single-Needle pressure port 3-12

Rinse port catch (gray) 3-8

Single-Needle pump 3-12

Rinse solution bag 7-13, 7-17 RO 13-3

Single-Needle specifications 12-16

Rocker switch button 3-24

Single-Needle User setup 4-95

Room temperature 4-97

Single-Needle, description 14-1

Rotor 3-10

SN line guide 7-15, 7-17

Power failure and battery operation 5-20

SafeLine™ 7-11, 7-15

Preparation 4-1, 12-8 Preparation using ONLINEplus™ 4-17

Safe workload 12-1, 13-2 SafeLine™ line guide 7-11, 7-15 SafeLine™ pump segment 7-11, 7-15 SafeLine™, inserting / retrofitting 4-108 SafeLine™, removing 4-107

Pressure displays (display / button) 3-19

Screen 3-6, 3-18

Pressure holding test 12-10

Screen failure 5-22

Pressure tubing 3-12, 14-17 Profiles 4-36, 4-52 Pulse 12-17 Pump housing 3-10 Pump segment 7-10, 7-12, 7-14, 7-16 Push handle 3-2

R Reaction ven. window alarm 4-82, 5-15 Rear view 3-2 Recessed handles 3-7

1-4

SN chamber 7-15, 7-17, 12-16 SN hydrophobic filter (WET) 4-82

S

Power switch 3-16

Single programs 4-89

Residual disinfectant (check) 6-13

Power failure (mains failure) 5-20

Power failure and empty battery 5-21

Shunt interlock 3-4

SN pressure line 7-15, 7-17 SN pump segment 7-15, 7-17 Sodium profiles 4-36, 4-52 Specifications 9-4, 12-1 Status (button) 3-18 Status bar 2-10, 3-18, 4-41, 4-44, 4-45, 4-50 Status indicator 3-6 Storage 10-3 Storage conditions 10-3

Screen colors 3-20

Strap for disinfectant canister 3-15

Screen failure sensor 3-6 Screen failure, no screen response 5-22

Stroke volume 12-16 Substituate connector (SafeLine™) 7-11, 7-15 Substituate port 3-8

Screen failure, screen dark or display distorted 5-22

Substituate port catch (blue) 3-8

Screen saver 3-25

Substituate pump 3-8

Screen, cleaning 6-20

Substitution 4-91

Selecting the concentrate supply 4-7

Suction tube flap 3-14 Supply point 3-2, 3-16

Selection screen 3-17

Surface cleaning 6-19, 8-3

Sequential therapy 13-2

Surface disinfection 6-19

ServiceCard 3-7, 13-2

Switching power off 6-21

Setting the venous alarm limit 4-13

Switching power on 4-5

Setting via numeric keypad 3-23

Symbols 13-4

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Chapter 1: Index

SYSTEM menu 4-63

Tubing systems (description) 7-10

Vent (water inlet chamber) 3-15

T

U

W

T1 test 4-9, 12-8

UF Menu 4-36, 4-37

Warning 5-2

Target group 2-5

UF parameters 4-35, 4-52

Warning symbol, significance 2-2

Technical documentation 2-7

UF profiles 4-36, 4-52

Warnings 2-7

Technical Safety Checks (TSC) 11-1

UF Timer I/O (button) 3-19

Warnings, consumables and accessories 2-16

Technical Safety Checks / maintenance 11-1 Technician's card 13-2 Terms 13-1 Therapy restrictions 2-4

UFC measurement 12-10 Ultrafiltration 4-80, 12-10

Warnings, electrical 2-14

User interface 3-17, 4-83

Warnings, hygiene 2-7

User setup 4-65, 4-66, 13-2

Warnings, system-specific 2-11

UserCard 3-7, 13-2

Warnings, therapy 2-8 Water alarms 13-2

Tilt hazard 2-11, 10-1

Water supply (permeate) 3-15

V

Time 4-64 Transmembrane pressure 12-10, 13-2

VAM 5-18

Transport 10-2

ven. hydrophobic filter (WET) 4-82

Transport / storage 10-1

VenAcc 14-5

Transport / storage / removal from service 10-1

VenAcc description 14-6

Tray for disinfectant canister 3-15

VenAcc specifications 12-16

Treatment 4-39

VenAcc surface cleaning 6-20

Treatment course 3-21

VenAcc User setup 4-97

Treatment data sheet 3-19

Venous bubble catcher 4-18, 4-23, 4-27, 4-32, 7-11, 7-12, 7-14, 7-16

Treatment, observe before and during 4-10 TSC 11-1, 13-3 Tubing system ONLINEplus™ 7-10

VAM description 5-18

VenAcc operation 14-8

Tubing system with rinse solution bag 7-12

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 rinse solution bag in case of SingleNeedle 4-31 Tubing system, removing 4-61 Tubing system, Single-Needle with rinse solution bag 7-16 Tubing systems 8-2

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WET 5-16 WET description 5-17 WET operation 5-17 WET User setup "Alarm processing" (SN hydrophobic filter) 4-82 WET User setup "Alarm processing" (ven. hydrophobic filter) 4-82

Venous line, changing 4-107 Venous measuring head (BTM) 3-12

Tubing system, inserting with rinse solution bag 4-22

Weight 12-1

Venous insertion site / sampling site 7-10, 7-12, 7-14, 7-16

Tubing system ONLINEplus™ Single-Needle 7-14

Tubing system, inserting with ONLINE in case of Single-Needle 4-26

Weekly programs 4-88

Venous patient line 7-11, 7-13, 7-15, 7-17 Venous pressure 3-19 Venous pressure line 7-10, 7-12, 7-14, 7-16 Venous pressure measurement 12-13 Venous pressure port 3-9 Venous tubing system 7-11, 7-12, 7-15, 7-16 Venous tubing system connector 7-10, 7-12, 7-14, 7-16

IFU-EN

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1-5

Chapter 1: Index

1-6

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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 – Document edition – 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.

Illustrations

The illustrations used in the documents may differ from the original if this does not have any influence on the function.

Importance of the Instructions for Use

These Instructions for Use are part of the accompanying documents and are an essential part of the device. They contain information necessary 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 must 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 with 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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2-1

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. – result in a specific function not being executed at all or not being executed correctly.

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 is 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 in the extracorporeal circuit is passed through the dialyzer. The blood can be continuously heparinized. An air bubble detector prevents the infusion of air to the patient. 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. 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 IEC 60601-1. The hemodialysis system is classified as Class II b (MDD) equipment. Among other things, the hemodialysis system uses "Free Software". For further information please refer to Chapter 15.

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2-3

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 instructions for use of the consumables.

2.6.2

Specification of use The device has been specified by the manufacturer for the following purposes: – Treatment of patients with a body weight of 40 kg or more. The safety systems and protective devices designed against potential errors and defects assume this as a basic condition. treatment of patients with a lower body weight is the responsibility of the attending physician. For this, the physician must take the deviation between the specified therapy values and the response values of the safety system into account. – operation in rooms that are suitable for dialysis located in professional health care institutions or for the home healthcare environment.

2.6.3

Side effects Hemodialysis occasionally causes hypotension, nausea, vomiting and cramps in some patients. Pay particular attention to 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

Therapy restrictions None

2-4

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Chapter 2: Important information

2.6.6

Interaction with other systems Tube pumps may cause minimal electrostatic discharges into the tubing system due to friction on the pump segment. As the charge is very low, these discharges do not represent a direct hazard to patients or operators. If ECG units are used at the same time, these discharges may, in rare cases, cause periodic interferences of the ECG signal. In order to minimize this interference, it is advisable to observe the recommendations of the ECG device manufacturer, e.g.: – correct positioning of the electrodes. – use of specific electrodes with low contact impedance

2.6.7

Target group The device must only be installed, operated and used by individuals with the appropriate training, knowledge and experience, and who are certified to have been trained.

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), maintenance procedures, and detailed explanations of how to perform them are described 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 Technical Safety Checks are performed to the full extent specified and at the prescribed intervals, the safe operation of the device in the time between TSC procedures is guaranteed. In addition, the manufacturer recommends that maintenance procedures be performed at the same time intervals to avoid device malfunctions caused by wear and tear. With each Technical Safety Check, the "expected service life" according to IEC 60601-1:2005 will therefore be prolonged until the next prescribed TSC.

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2-5