Transcription
5008Hemodialysis SystemOperating InstructionsSoftware version: 3.52Edition: 5/09.06Part no.: M38 816 1!Caution!These Operating Instructions in pdfformat are for information only.They are not a replacement for theOperating Instructions supplied withthe machine/device and options.0123Fresenius Medical Care
Table of ContentsPage1Index2Important Information3452.1Important Information on the Operating Instructions. 2-12.2Important Information on the System. 2-32.3Addresses . 2-8Design3.1Front View . 3-13.2Rear View . 3-23.3Lateral View, Left Side . 3-33.4Lateral View, Right Side. 3-43.5Monitor Front . 3-63.6Monitor Rear . 3-73.7Extracorporeal Blood Module . 3-83.8Extracorporeal Blood Module with Additional Functions . 3-123.9Hydraulics . 3-133.10Hydraulics Connectors . 3-143.11External Connection Options/Connection to Power Supply . 3-15Graphical User Interface4.1After Turning Power on to the System . 4-14.2Overview (Screen) . 4-24.3General Operation Philosophy. 4-34.4Examples for Data Entry (Treatment Data) . 4-74.5Screen Saver. 4-9Preparation5.1Preparation using ONLINEplus . 5-15.2Preparation with Rinse Solution Bag . 5-175.3Single-Needle (Option) Preparation Using ONLINEplus . 5-315.4Single-Needle (Option) Preparation with Rinse Solution Bag. 5-47Fresenius Medical Care5008OP5/09.06iii
Table of plus . 6-16.2Treatment (Prepared with Rinse Solution Bag) . 6-56.3Single-Needle (Option) Treatment Using ONLINEplus . 6-96.4Single-Needle (Option) Treatment (Prepared with Rinse Solution Bag) . 6-17Reinfusion7.1Reinfusion using ONLINEplus . 7-17.2Reinfusion with Rinse Solution Bag . 7-57.3Single-Needle (Option) Reinfusion Using ONLINEplus . 7-97.4Single-Needle (Option) Reinfusion with Rinse Solution Bag . 7-9Cleaning8.1Basic Requirements . 8-18.2Connecting the Disinfectant Container . 8-28.3Starting a Cleaning / Disinfection Program. 8-38.4Aborting a Cleaning / Disinfection Program . 8-48.5Cleaning / Disinfection Program Complete. 8-48.6Checking for Residual Disinfectant . 8-58.7Surface Cleaning / Disinfection. 8-58.8Turning the Hemodialysis System Off. 8-6Alarm Processing9.1Messages (Information/Warning/Alarm). 9-19.2Air Detected Below the Venous Bubble Catcher . 9-29.3Micro Bubbles Detected Below the Venous Bubble Catcher . 9-79.4Management of Alarm Limits. 9-149.5Blood Leak . 9-149.6Conductivity . 9-159.7Manually Opening the Arterial Pressure Measurement Unit . 9-159.8Power Failure (Outage) . 9-159.9Screen Failure . 9-17Fresenius Medical Care5008OP5/09.06
Table of ContentsPage10 Other Functions10.1SYSTEM SCREEN Settings. 10-110.2Operator Setup . 10-210.3Emergency Button. 10-2610.4Emptying / Changing the bibag . 10-2610.5Changing the DIASAFE plus . 10-2710.6Cleaning the Dialysate Particle Filter . 10-2810.7Collecting a Sample . 10-2810.8Removing Lines During Preparation . 10-2810.9Removing Lines During Treatment. 10-2910.10Circulation. 10-3010.11Setting the Level in the Venous Bubble Catcher. 10-3110.12Single-Needle Click-Clack . 10-3211 System Description11.1Specifications . 11-111.2Storage . 11-1611.3Transportation . 11-1611.4Environmental Compatibility and Recycling . 11-1711.5System Description . 11-2211.6Blood Lines (Description). 11-3411.7Initial Start-Up . 11-4211.8Technical Safety Checks and Technical Measurement Checks . 11-4711.9Definitions and Terms. 11-5211.10Abbreviations. 11-5311.11Symbols. 11-5411.12Consumables Symbols . 11-5512 Consumables12.1To be Observed in Chapter Consumables . 12-112.2Dialyzers. 12-112.3Blood Lines . 12-112.4Disposable Syringes . 12-212.5Hemodialysis Concentrates . 12-212.6Dialysate Filter DIASAFE plus. 12-2Fresenius Medical Care5008OP5/09.06v
Table of ContentsPage12.7Surface Disinfection / Surface Cleaning. 12-312.8Disinfectants for the Hydraulics. 12-312.9Disinfectant Indicators . 12-413 Certificates13.1EC Certificate . 13-114 Appendix14.1Bibliography. 14-115 Option OCM (Online Clearance Monitoring)15.1To Be Observed Before Using the OCM . 15-115.2Menu Overview . 15-215.3Checking/Setting the OCM Parameters . 15-315.4Stability Criteria . 15-415.5Starting the OCM . 15-415.6Aborting the OCM . 15-415.7Alarm Processing . 15-516 ONLINEplus 16.1Menu Overview . 16-216.2Preparation/Treatment/Reinfusion. 16-317 Option SN (Single-Needle)17.1Menu Overview . 17-217.2Preparation/Treatment/Reinfusion. 17-318 Option BPM (Blood Pressure Monitoring)vi18.1To Be Observed Before Using the BPM Option. 18-118.2Blood Pressure Cuffs / Pressure Tubing. 18-118.3Menu Overview . 18-218.4Applying the Blood Pressure Cuff . 18-3Fresenius Medical Care5008OP5/09.06
Table of ContentsPage18.5Checking/Setting the Inflation Pressure/Alarm Limits. 18-318.6Starting the Blood Pressure Measurement. 18-418.7Blood Pressure Measurement Completed . 18-418.8Aborting the Blood Pressure Measurement . 18-518.9Displaying Graphics and Blood Pressure History . 18-519 Option CBPM20 Option BTM (Blood Temperature Monitor)20.1To Be Observed Before Using the BTM Option. 20-120.2Menu Overview . 20-220.3Preparation. 20-320.4Recirculation. 20-320.5Temperature Control . 20-420.6Displaying Graphics and BTM Events. 20-421 Option BVM (Blood Volume Monitor)21.1To Be Observed Before Using the BVM Option. 21-121.2Menu Overview . 21-221.3Preparation. 21-421.4Calibration. 21-421.5Measuring the RBV (Relative Blood Volume), Hemoglobin and Hematocrit . 21-421.6Displaying Graphics. 21-521.7Alarm Processing . 21-522 Network22.1To Be Observed Before Using the Network . 22-122.2DataXchange Panel . 22-123 Options BLK, WET23.1To be Observed Before Using the BLK, WET Options. 23-123.2BLK . 23-123.3WET. 23-2Fresenius Medical Care5008OP5/09.06vii
Table of ContentsPage24 Option smartbagviii24.1To Be Observed Before Using the smartbag Option. 24-124.2Connecting the smartbag . 24-124.3Removing the smartbag. 24-2Fresenius Medical Care5008OP5/09.06
Chapter 1: Index1IndexHow to use the index: Index entry 1-3, for example, refers to chapter 1, page 3AAuto-Single-Needle 11-13BPM 3-12, 10-24, 11-30, 18-1Abbreviations 11-53Auto-sub 10-21BPM pressure port 3-12Bracket (heparin pump) 3-10ABD handling (air removal) 9-3BBrake 3-3, 3-4Brief description 2-3Additional optional equipment 2-6Barrel holder with syringe detector3-10Addresses 2-8Battery 11-16, 11-44Air bubble detector 3-11, 11-11bibag 5-20, 5-34, 5-50, 7-3, 7-6,11-27Acetate dialysis 5-4, 5-20, 5-34,5-50Air removal 9-3bibag port 3-13Alarm 9-1bibag , connecting 5-4, 5-20,5-34, 5-50Alarm limits, management 9-14Alarm output (staff call) 3-15bibag , emptying/changing 10-26Alarm override 11-7Bibliography 14-1Alarm processing 9-1, 10-14Bicarbonate dialysis 5-3, 5-19,5-33, 5-49Anticoagulation 10-3AquaUNO 2-6, 3-15, 11-6Bicarbonate flap 3-13Arterial blood line 11-34, 11-36,11-38, 11-40Bicarbonate suction tube (blue)3-13Arterial blood line (Single-Needlepart) 11-39, 11-41Arterial injection site/collection site11-34, 11-36, 11-38, 11-40BTM 3-12, 10-25, 11-25, 11-31,20-1BTM (arterial measuring head)3-12BTM (venous measuring head)3-12Bubble catcher 11-52BVM 3-12, 10-24, 11-25, 11-32,21-1BVM measuring head 3-12CCard receptacle 3-7BLK 23-1Central delivery system (CDS)5-4, 5-20, 5-34, 5-50Blood alarms 11-23, 11-52Certificates 13-1Blood flow 4-3Circulation 10-30Arterial line, removing 10-29Blood leak detector 11-8Arterial measuring head (BTM)3-12Blood lines 12-1Clamping lever (heparin pump)3-10Blood lines (description) 11-34Cleaning (basic requirements) 8-1Arterial occlusion clamp 3-8Arterial patient connection 11-34,11-36, 11-38, 11-40Arterial pressure 4-3Arterial pressure dome 5-8, 5-24,5-38, 5-54, 11-34, 11-36, 11-38,11-40Arterial pressure measurementunit 3-8, 5-6, 5-8, 5-22, 5-24,5-36, 5-38, 5-52, 5-54, 9-15,11-22Cleaning program 8-3, 8-4Blood lines with ONLINEplus Single-Needle 11-38Concentrate flap 3-13Blood lines with rinse solution bag11-36Blood Lines with Single Needlewith rinse solution bags 11-40Blood lines, removing 7-3, 7-7Blood pressure 4-3, 11-13Arterial pressure measurementunit, opening manually 9-15Audible alarm 11-12Audible alarm suppression 11-6Auto On 10-18AutoFlow 11-9Fresenius Medical CareBlood lines with ONLINEplus 11-34Cleaning programs 11-8Concentrate rack 3-3, 3-4, 5-3,5-19, 5-33, 5-49Concentrate suction tube (red)3-13Concentrate supply, selecting 5-3,5-19, 5-33, 5-49Blood pressure cuff 3-12Concentrates 5-3, 5-19, 5-33,5-49, 11-9Blood pressure cuffs 18-1Conductivity 11-52Blood pressure measurement18-1Conductivity alarm 9-15Blood pump 3-8, 3-10, 10-2Connection, venous pressure line11-34, 11-36, 11-38, 11-40Body temperature control 11-14Connector for BIC, blue 3-14Connector for CDS 1, red 3-145008OP5/09.061-1
Chapter 1: IndexConnector for CDS 2, red 3-14Dimensions 11-1Flush 11-8Connector postdilution 11-35,11-39Disclaimer of liability 2-5Flush drain 3-14Disinfectant connector, black 3-14Front view 3-1Connector pre/postdilution(SafeLine ) 11-35, 11-39Disinfectant connector, yellow3-14Fuses 11-2Disinfectant container, connecting8-2GConnector predilution 11-35,11-39Connector, SN pressure line11-39, 11-41Consumables 12-1Contraindications 2-4Course of the treatment 4-5Cuff holder 3-12DData entry, examples (treatmentdata) 4-7Disinfectant indicators 12-4General operation philosophy 4-3Graphical user interface 4-1Disinfectants 12-3Grip handle (heparin pump) 3-10Disinfection 8-1Disinfection program 8-3, 8-4Display failure sensor 3-6Double-Needle 5-1, 5-17, 5-31,5-47, 6-1, 6-5, 7-1, 7-5Duties of the responsibleorganization 2-4Groove 3-8Guarantee 2-5Guarantee / warranty 2-5HHandle 9-16, 9-17Decalcification 12-3EHandle for an emergencyoperation 3-10Define options 10-15EBM 11-53Header bar 4-4Definitions and terms 11-52EcoFlow 5-12, 5-27, 5-42, 5-57,11-10Hemodialysis concentrates 12-2Degreasing 12-4Design 3-1Electrical safety 11-2Dialysate couplings 3-5Electrical supply 11-2Dialysate flow 11-9Electromagnetic compatibility(EMC) 11-3, 11-53Dialysate flow status indicator 4-2Dialysate lines 3-4, 5-11, 5-26,5-41, 5-56EMC 11-3, 11-53Dialysate menu 5-12, 5-14, 5-27,5-29, 5-42, 5-44, 5-57, 5-59Emergency button 4-3, 10-19,10-26Dialysate parameters 5-12, 5-27,5-42, 5-57, 6-3, 6-6, 6-13, 6-20Emergency operation 9-16, 9-17Dialysate particle filter, cleaning10-28External connection options 3-2,3-15, 11-6Dialysate return line 3-4Dialysate temperature 11-9Extracorporeal blood module(EBM) 3-1, 3-8, 3-12, 5-8, 5-11,5-24, 5-26, 5-38, 5-41, 5-54, 5-56Dialyzer 11-34, 11-36, 11-38,11-40FDialysate supply line 3-4Emergency 10-19Environmental compatibility 11-17Hemodialysis system, turning off8-6Hemodialysis system, turning on5-1, 5-17, 5-31, 5-47Heparin (menu) 5-15, 5-30, 5-45,5-60Heparin line 11-35, 11-36, 11-39,11-41Heparin menu 4-3Heparin pump 3-8, 3-10, 11-12,11-22Heparin pump parameters 5-15,5-30, 5-45, 5-60, 6-4, 6-7, 6-15,6-21Heparin status indicator 4-3Heparin syringe 5-9, 5-25, 5-39,5-55, 11-35, 11-36, 11-39, 11-41,12-2Dialyzer connector (arterial bloodline) 11-34, 11-36, 11-38, 11-40Fan filter (service door) 3-2Holder for disinfectant container3-14Dialyzer connector (venous bloodline) 11-34, 11-36, 11-38, 11-40Fields of application 2-4Holder for SN chamber 3-12Filter 1 - DIASAFE plus 3-4Dialyzer holder 3-4, 3-5Dialyzer, emptying 7-2, 7-6Dialyzers 12-1DIASAFE plus 11-12, 12-2DIASAFE plus, changing 10-271-2Filter 2 - ONLINEplus 3-4Filter chamber 3-4Hydraulics 3-1, 3-2, 3-13, 3-14Hydraulics connectors 3-2, 3-14Fixation for the plunger (heparinpump) 3-10IFlow alarm 11-11Indibag flap 3-13Flow diagram 11-26Identification 2-1Fresenius Medical Care5008OP5/09.06
Chapter 1: IndexInfo 4-3, 9-1Message button 4-2Infusion solution 6-7, 6-22Messages 9-1Infusion solutions, administering6-7, 6-22Micro bubbles 9-7Patient, disconnecting withONLINE and Single-Needle 7-9PatientCard 3-7, 10-20Micro bubbles removal 9-10Potential equalization 3-14, 11-42Initial start-up 2-6, 11-42Micro bubbles, overriding 9-9Intended use 2-4Miscellaneous 10-23Power connection (supply point)3-2, 3-15International service 2-8Monitor 3-1, 3-6, 3-7ISO-UF (Sequential therapy) 11-7,11-52IV pole 3-4, 3-5KKinking warning 10-14Kt/V 15-1Monitor arm 3-7Power failure and batteryoperation 9-15NPower failure and depleted battery9-16Network (LAN) 3-15, 11-15, 22-1Power switch 3-15Numeric keypad 4-7Preparation 5-1, 11-7OKt/V warning 10-22OCM 10-22, 11-13, 11-27, 15-1OCM (menu) 15-3LOnline (bolus) 6-2, 6-11, 10-21LAN (network) 3-15, 11-15, 22-1ONLINE preparation 5-1Leakage sensor, extracorporealblood module 3-8Leakage sensor, filter chamber 3-4LED/keys 3-6Level detector 3-11, 11-11Power failure (outage) 9-15ONLINE preparation with SingleNeedle 5-31ONLINEplus 3-9, 5-1, 5-31,6-1, 6-9, 7-1, 7-9, 10-21, 11-24,11-28, 16-1Preparation with rinse solution bag5-17Pressure displays 4-3Pressure holding test 11-8Pressure tubing 3-12, 18-2Prime collection bag 11-37, 11-41Profiles 5-13, 5-29, 5-43, 5-59,6-4, 6-6, 6-14, 6-21Pulse 11-14Pump segment 11-34, 11-36,11-38, 11-40Push handle 3-2Level, setting level in SN chamber6-12Operating conditions 11-5Level, setting the level in thevenous bubble catcher 10-31Operating mode indicator 3-6ROperating programs 11-7Rear view 3-2Operator Setup 10-2Recessed handle 3-7Optical detector 3-11, 5-9, 5-25,5-39, 5-55, 11-11Recirculating adapter (SafeLine )11-35, 11-39Outage (power failure) 9-15Recirculation 11-31Outlet line 3-14Recirculation measurement 11-14Override conditions 11-6Recycling 11-17Line guide 3-10, 11-34, 11-36,11-38, 11-40Line guides 3-8Line holder (for transport) 3-2Line holder for SafeLine 3-9Lines, removing all 10-30Lines, removing duringPreparation 10-28Operating mode 4-2Overview (screen) 4-2Lines, removing during treatment10-29PLoudspeaker 3-7Page setup 3-3, 3-4Particle filter, dialysate 3-4MManufacturer 2-8Materials 11-17, 11-20Materials used 11-17Menu panel 4-35008OPRestrictions 2-4Rinse connector 11-35, 11-39Rinse port 3-8Patient, connecting with ONLINE6-1Rinse solution bag 11-36, 11-41Patient, disconnecting withONLINE 7-1Menu structure, design 4-6Residual disinfectant, checking8-5Patient ID (treatment data sheet)4-3Patient, connecting with ONLINEand Single-Needle 6-9Menu buttons 4-3Fresenius Medical CareReinfusion 7-1, 10-3Repair 2-75/09.06Rinse port catch (grey) 3-8Rinse/reinfusion volume 10-3Rocker switch 4-8Room temperature 10-25Rotor 3-101-3
Chapter 1: IndexSSafeLine 11-35, 11-39SafeLine line guide 11-35,11-39SafeLine pump segment 11-35,11-39SN pressure line 11-39, 11-41Turning power off 8-6SN pump segment 11-39, 11-41Turning power on 5-1, 5-17, 5-31,5-47Sodium profiles 5-13, 5-29, 5-43,5-59, 6-4, 6-6, 6-14, 6-21Type label 11-1Specifications 11-1, 11-44Start-up requirements 2-6USafeLine , connecting/retrofitting10-30Start-up screen 4-1UF menu 5-13, 5-14, 5-28, 5-29,5-43, 5-44, 5-58, 5-59SafeLine , removing 10-29Storage 11-16Safety precautions 2-5Stroke volume 11-13Safety precautions (basic) 2-5Substituate catch (blue) 3-8Safety precautions (electrichazards) 2-6Substituate connector(SafeLine ) 11-35, 11-39UF Timer I/O 4-3Safety precautions, signification2-2Substituate port 3-8UFK-Messung 11-9Sampling 10-28Screen 3-6, 4-2Screen colors 4-4Screen failure 9-17Status 4-2UF parameters 5-12, 5-28, 5-42,5-58, 6-3, 6-6, 6-14, 6-21UF profiles 5-13, 5-29, 5-43, 5-59,6-4, 6-6, 6-14, 6-21Substituate pump 3-8Ultrafiltration 10-13, 11-8Substitution 10-21User interface 10-14Supply point 3-2, 3-15UserCard 3-7Surface cleaning 8-5, 12-3Symbols 11-54VSystem description 11-1, 11-22Screen failure, screen dark ordisplay distorted 9-17Venous blood line 11-35, 11-36,11-38, 11-40TScreen saver 4-9T1 test 11-7Screen, cleaning 8-5Technical documentation 2-7Venous bubble catcher 5-9, 5-25,5-39, 5-55, 11-35, 11-36, 11-38,11-40Selection screen 4-1Technical measurement checks(TMC) 2-6, 11-47, 11-54Screen failure, no screen reaction9-17Service Central Europe 2-8Service door 3-2ServiceCard 3-7Setting via numeric keypad 4-7Setting via rocker switch 4-8Settings, SYSTEM SCREEN 10-1Setup 10-2Shunt door 3-4, 3-5Shunt interlock 3-4Side effects 2-4Single programs 10-18Single-Needle 3-12, 10-23, 11-13,11-25, 11-29, 11-53Single-Needle Click-Clack 10-23,10-32, 11-12, 11-23Single-Needle pressure port 3-12Single-Needle pump 3-12smartbag 24-1SN chamber 11-13, 11-39, 11-41SN line guide 11-39, 11-411-4Technical safety checks (TSC)2-6, 11-47Terms 11-52Venous injection site/collectionsite 11-34, 11-36, 11-38, 11-40Venous line, removing 10-29Venous measuring head (BTM)3-12Venous monitoring function 3-8,3-11TMC 2-6, 11-47, 11-54Transmembrane pressure 11-8,11-53Venous occlusion clamp 3-8Transportation 11-16Venous patient connection 11-35,11-36, 11-39, 11-40Tray for disinfectant container 3-14Venous pressure 4-3Treatment 6-1Venous pressure line 11-34,11-36, 11-38, 11-40Treatment data sheet 4-3TSC 2-6, 11-47, 11-54Tubing system, inserting withONLINE 5-8Tubing system, inserting withONLINE in case of Single-Needle5-38Tubing system, inserting with rinsesolution bag 5-24Tubing system, inserting with rinsesolution bag in case of SingleNeedle 5-54Venous pressure measurement11-11Venous pressure port 3-9Venous transducer 10-14Vent (mixing chamber) 3-14Vent (water inlet chamber) 3-14WWarning 9-1Warranty 2-5Fresenius Medical Care5008OP5/09.06
Chapter 1: IndexWater alarms 11-53Water supply 11-44, 11-45Water supply (permeate) 3-14Weekly programs 10-18Weight 11-1WET 23-1Fresenius Medical Care5008OP5/09.061-5
Chapter 1: Index1-6Fresenius Medical Care5008OP5/09.06
Chapter 2: Important Information2Important Information2.1Important Information on the Operating Instructions2.1.1How to Use the Operating InstructionsIdentificationThe document can be identified by the following information on the titlepage and on the labels, if any:– Software version of the system– Edition of the technical document– Part number of the technical documentPage identificationThe page identification 1-3, for example, refers to Chapter 1, page 3.Editorial informationThe editorial information 1/01.05, for example, refers to: 1. edition,January 2005.ChangesDocument changes will be released as new editions or supplements. Ingeneral, this manual is subject to change without notice.Importance of theinstructionsThese Operating Instructions are part of the accompanying documentsand an integral part of the system. They contain inform
Blood alarms 11-23, 11-52 Blood flow 4-3 Blood leak detector 11-8 Blood lines 3-1012-1 Blood lines (description) Cleaning (basic requirements)11-34 Blood lines with ONLINEplus Cleaning program 11-34 Blood lines with ONLINEplus Single-Needle 11-38 Blood lines with rinse solution bag 11-36 Blood
