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Fresenius Medical Care 5008, Operating Instructions Manual

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Chapter 11:  System Description

11-50

Fresenius Medical Care 5008 OP 5/09.06

7.3

Leakage current (device leakage current) measured.

T

 Differential current measurement according to figure C.6

or

T

 Direct measurement according to figure C.5

T

 

Nominal voltage of power supply: _______ V

Device leakage current mains polarity 1: _______

μ

A

with line voltage: _______ V
scaled to nominal voltage
(maximum 500

μ

A, see Additional requirements)

_____

μ

A

Device leakage current mains polarity 2: _______

μ

A

with line voltage: _______ V
scaled to nominal voltage
(maximum 500

μ

A, see Additional requirements)

_____

μ

A

8

 

Final inspection and testing

 

8.1

T1 test performed with all options.

T

 

8.2

Disinfection performed.

T

 

Test equipment used:

 

Temperature, conductivity, pressure
(type, serial number):
________________________________________________________________________________________

Protective earth resistance, leakage current
(type, serial number):
________________________________________________________________________________________

Comments:

 

Date:

 

Signature:

 

Stamp:

 

No. 

Description 

Correct. 

Meas. 
value 

 

Summary of Contents for 5008

Page 1: ...re version 3 52 Edition 5 09 06 Part no M38 816 1 0123 Fresenius Medical Care Caution These Operating Instructions in pdf format are for information only They are not a replacement for the Operating Instructions supplied with the machine device and options ...

Page 2: ......

Page 3: ...3 8 3 8 Extracorporeal Blood Module with Additional Functions 3 12 3 9 Hydraulics 3 13 3 10 Hydraulics Connectors 3 14 3 11 External Connection Options Connection to Power Supply 3 15 4 Graphical User Interface 4 1 After Turning Power on to the System 4 1 4 2 Overview Screen 4 2 4 3 General Operation Philosophy 4 3 4 4 Examples for Data Entry Treatment Data 4 7 4 5 Screen Saver 4 9 5 Preparation 5...

Page 4: ... 1 Basic Requirements 8 1 8 2 Connecting the Disinfectant Container 8 2 8 3 Starting a Cleaning Disinfection Program 8 3 8 4 Aborting a Cleaning Disinfection Program 8 4 8 5 Cleaning Disinfection Program Complete 8 4 8 6 Checking for Residual Disinfectant 8 5 8 7 Surface Cleaning Disinfection 8 5 8 8 Turning the Hemodialysis System Off 8 6 9 Alarm Processing 9 1 Messages Information Warning Alarm ...

Page 5: ...le Catcher 10 31 10 12 Single Needle Click Clack 10 32 11 System Description 11 1 Specifications 11 1 11 2 Storage 11 16 11 3 Transportation 11 16 11 4 Environmental Compatibility and Recycling 11 17 11 5 System Description 11 22 11 6 Blood Lines Description 11 34 11 7 Initial Start Up 11 42 11 8 Technical Safety Checks and Technical Measurement Checks 11 47 11 9 Definitions and Terms 11 52 11 10 ...

Page 6: ...2 Menu Overview 15 2 15 3 Checking Setting the OCM Parameters 15 3 15 4 Stability Criteria 15 4 15 5 Starting the OCM 15 4 15 6 Aborting the OCM 15 4 15 7 Alarm Processing 15 5 16 ONLINEplus 16 1 Menu Overview 16 2 16 2 Preparation Treatment Reinfusion 16 3 17 Option SN Single Needle 17 1 Menu Overview 17 2 17 2 Preparation Treatment Reinfusion 17 3 18 Option BPM Blood Pressure Monitoring 18 1 To ...

Page 7: ...on 20 1 20 2 Menu Overview 20 2 20 3 Preparation 20 3 20 4 Recirculation 20 3 20 5 Temperature Control 20 4 20 6 Displaying Graphics and BTM Events 20 4 21 Option BVM Blood Volume Monitor 21 1 To Be Observed Before Using the BVM Option 21 1 21 2 Menu Overview 21 2 21 3 Preparation 21 4 21 4 Calibration 21 4 21 5 Measuring the RBV Relative Blood Volume Hemoglobin and Hematocrit 21 4 21 6 Displaying...

Page 8: ...e of Contents Page viii Fresenius Medical Care 5008 OP 5 09 06 24 Option smartbag 24 1 To Be Observed Before Using the smartbag Option 24 1 24 2 Connecting the smartbag 24 1 24 3 Removing the smartbag 24 2 ...

Page 9: ... bibag emptying changing 10 26 Bibliography 14 1 Bicarbonate dialysis 5 3 5 19 5 33 5 49 Bicarbonate flap 3 13 Bicarbonate suction tube blue 3 13 BLK 23 1 Blood alarms 11 23 11 52 Blood flow 4 3 Blood leak detector 11 8 Blood lines 12 1 Blood lines description 11 34 Blood lines with ONLINEplus 11 34 Blood lines with ONLINEplus Single Needle 11 38 Blood lines with rinse solution bag 11 36 Blood Lin...

Page 10: ...Display failure sensor 3 6 Double Needle 5 1 5 17 5 31 5 47 6 1 6 5 7 1 7 5 Duties of the responsible organization 2 4 E EBM 11 53 EcoFlow 5 12 5 27 5 42 5 57 11 10 Electrical safety 11 2 Electrical supply 11 2 Electromagnetic compatibility EMC 11 3 11 53 EMC 11 3 11 53 Emergency 10 19 Emergency button 4 3 10 19 10 26 Emergency operation 9 16 9 17 Environmental compatibility 11 17 External connect...

Page 11: ... 5 1 5 31 6 1 6 9 7 1 7 9 10 21 11 24 11 28 16 1 Operating conditions 11 5 Operating mode 4 2 Operating mode indicator 3 6 Operating programs 11 7 Operator Setup 10 2 Optical detector 3 11 5 9 5 25 5 39 5 55 11 11 Outage power failure 9 15 Outlet line 3 14 Override conditions 11 6 Overview screen 4 2 P Page setup 3 3 3 4 Particle filter dialysate 3 4 Patient ID treatment data sheet 4 3 Patient con...

Page 12: ... 3 8 Substitution 10 21 Supply point 3 2 3 15 Surface cleaning 8 5 12 3 Symbols 11 54 System description 11 1 11 22 T T1 test 11 7 Technical documentation 2 7 Technical measurement checks TMC 2 6 11 47 11 54 Technical safety checks TSC 2 6 11 47 Terms 11 52 TMC 2 6 11 47 11 54 Transmembrane pressure 11 8 11 53 Transportation 11 16 Tray for disinfectant container 3 14 Treatment 6 1 Treatment data s...

Page 13: ...Chapter 1 Index Fresenius Medical Care 5008 OP 5 09 06 1 5 Water alarms 11 53 Water supply 11 44 11 45 Water supply permeate 3 14 Weekly programs 10 18 Weight 11 1 WET 23 1 ...

Page 14: ...Chapter 1 Index 1 6 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 15: ...o change without notice Importance of the instructions These Operating Instructions are part of the accompanying documents and an integral part of the system They contain information necessary for the use of the system The Operating Instructions must be carefully studied before attempting to operate the system Before the responsible organization may start operating the system the person responsibl...

Page 16: ...ion on the following symbol Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on individuals Note Informs the operator that in case of a failure to follow the steps as described a specific function will be executed incorrectly or will not be executed at all or will not produce the desired effect Here you will fin...

Page 17: ...s infusion of air Any dangerous loss of blood is prevented by a blood leak detector a fluid detector and by monitoring the venous return pressure The arterial pressure monitoring unit detects an aspiration of the needle in the vessel The hemodialysis system 5008 is designed for both acetate dialysis and bicarbonate dialysis The mixing ratio the Na concentration and the bicarbonate concentration ma...

Page 18: ...lemia 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 in hemodynamically unstable patients O Restrictions None 2 2 3 Target Group The system may only be installed operated and used by persons with the appropriate training knowl...

Page 19: ...dical products The manufacturer does not assume any responsibility or liability for personal injury or other damage and excludes any warranty for damage to the system resulting from the use of non approved or unsuitable consumables or accessories 2 2 6 Guarantee Warranty O Guarantee For guarantee refer to the respective sales contracts O Warranty The customer s rights of warranty depend on the app...

Page 20: ...emodialysis system shows signs of mechanical damage preventing safe operation stop using the machine Applied parts that are damaged must be replaced 2 2 11 Operation The following must be observed when entering parameters The parameters entered must be verified by the operator i e the operator must check that the values entered are correct If the verification reveals a deviation between the desire...

Page 21: ...cuit diagrams descriptions spare parts lists and other documents These are intended to support trained personnel in servicing and repairing the machine The following is also available on request Test procedure by which the effectiveness of sterilization or disinfection has been verified Comments concerning the expected recirculation of the blood flow in the extracorporeal circuit in Single Needle ...

Page 22: ...ntral Europe Fresenius Medical Care Deutschland GmbH Geschäftsbereich Zentraleuropa Kundendienst Servicecenter Steinmühlstraße 24 61352 Bad Homburg Germany Phone 49 6172 609 7100 Fax 49 6172 609 7102 E mail ServicecenterD fmc ag com International Service Fresenius Medical Care Deutschland GmbH Service Support International Hafenstrasse 9 D 97424 Schweinfurt Germany Phone 49 9721 678 333 hotline Fa...

Page 23: ...Chapter 3 Design Fresenius Medical Care 5008 OP 5 09 06 3 1 3 Design 3 1 Front View 1 Monitor 2 Extracorporeal blood module 3 Hydraulics 1 2 3 ...

Page 24: ...dical Care 5008 OP 5 09 06 3 2 Rear View 1 Monitor 2 External connection options 3 Push handle 4 Fan filter service door 5 Power connection supply point 6 Line holder for transport 7 Service door 8 Hydraulic connectors 2 3 4 8 6 1 5 7 ...

Page 25: ...rom the tray a Push the cover down and turn it b Pull the cover out To extract the concentrate rack Push with your foot from the front against the rack To retract the concentrate rack Push with your foot from the front against the rack until it clicks into place To apply or release the brake a Push the lever down to apply the brake b Push the lever down to release the brake 1 2 3 a b b a ...

Page 26: ...nes 4 Shunt interlock 5 Dialysate return line dialyzer coupling blue 6 Dialysate supply line dialyzer coupling red 7 Concentrate rack extractable 8 Brake 9 Leakage sensor filter chamber 10 Particle filter dialysate 11 Filter 1 DIASAFE plus right 12 Filter 2 ONLINEplus left 13 Door filter chamber 14 Filter chamber 2 3 7 8 1 6 5 4 9 10 13 14 12 11 ...

Page 27: ...ess or pull the lever c to swivel the dialyzer holder to the right When the right hand door is opened the dialyzer holder will automatically move to the right To open or close the shunt door Open the shunt door by flipping it to the top a Close the shunt door by flipping it down b To remove the dialysate couplings Push the lever down and hold it and remove the dialysate coupling To move the hemodi...

Page 28: ...system Stop LED key red 4 Blood system Start LED key green 5 Mute LED key red LED is illuminated audible alarm suppressed LED is flashing audible alarm active 6 Screen 7 Operating mode indicator green yellow red LED is green to indicate correct operation LED is yellow in case of a warning or an info LED is yellow and flashing in Emergency mode LED is red in case of an alarm LED is not illuminated ...

Page 29: ... receptacle for PatientCard UserCard ServiceCard 2 Loudspeaker 3 Recessed handle 4 Monitor arm 1 2 3 4 To move the monitor To bring the monitor into the desired position it can be swiveled about three axes a b c a To move it hold the monitor at the points shown b Insert card a b c b a ...

Page 30: ...bstituate catch lock blue 8 Substituate port hidden by the substituate catch blue 9 Rinse port hidden by the rinse port catch grey 10 Rinse port catch grey 11 Groove 12 Leakage sensor extracorporeal blood module 13 Venous occlusion clamp 14 Venous monitoring function optical detector air bubble detector 15 Locator for venous bubble catcher 16 Venous monitoring function level detector 7 8 9 10 1 2 ...

Page 31: ...Chapter 3 Design Fresenius Medical Care 5008 OP 5 09 06 3 9 17 Line holder for SafeLine 18 Line holder 19 Venous pressure port Open or close the doors on the upper side as shown in the illustration ...

Page 32: ...pump 1 Holder shape coded for line guide 2 Rotor 3 Handle for an emergency operation 4 Key ejector for inserting and removing the line segment 5 Line pulleys 1 Barrel holder with syringe detector 2 Bracket 3 Fixation for the plunger 4 Grip handle 5 Clamping brackets 1 5 4 3 2 1 2 3 5 4 ...

Page 33: ... 5008 OP 5 09 06 3 11 O Venous fill level and air monitoring function 1 Tension lever with level detector for the venous bubble catcher 2 Locator for venous bubble catcher 3 Optical detector 4 Air bubble detector ABD 5 Line housing 5 1 2 3 4 ...

Page 34: ...unctions BPM option 1 Blood pressure cuff 2 Cuff holder 3 Pressure port BPM 4 Pressure tubing SN option 5 Single Needle pressure port 6 Single Needle pump 7 Holder for SN chamber with mark BVM option 8 BVM measuring head BTM option 9 Arterial measuring head BTM 10 Venous measuring head BTM 2 5 1 4 3 10 7 6 9 8 ...

Page 35: ...ius Medical Care 5008 OP 5 09 06 3 13 3 9 Hydraulics 1 Bicarbonate flap 2 Bicarbonate suction tube blue 3 bibag port 4 Indibag flap 5 indibag port 6 Concentrate flap 7 sobag port 8 Concentrate suction tube red 3 2 1 5 4 7 8 6 ...

Page 36: ... for disinfectant container 4 Tray for disinfectant container 5 Potential equalization 6 Drain 7 Flush drain option 8 Water supply permeate 9 Vent water inlet chamber 10 Vent mixing chamber 11 Connector for CDS 1 red Central Delivery System acid 1 12 Connector for CDS 2 red Central Delivery System acid 2 option 13 Connector for BIC blue central bicarbonate supply option 1 8 2 3 4 10 11 12 13 9 7 6...

Page 37: ...r Supply 1 LAN local area network network connection 2 Service diagnostics RS232 24 V Connector for AquaUNO single station reverse osmosis unit 3 Alarm output staff call 4 Power connection supply point 5 Power switch Caution Before connecting any optional equipment observe the notes under Specifications 1 5 4 2 3 ...

Page 38: ...Chapter 3 Design 3 16 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 39: ...After Turning Power on to the System START UP SCREEN The display shows the machine type the current software version and the clinical data on request for approx 15 seconds SELECTION SCREEN The following selections are possible Treatment Cleaning program e g Rinse Touch the desired button to make your selection ...

Page 40: ... bar is moving Bypass waves green grey bar is not moving Flow turned off waves grey 3 Status Displays data on the system condition Software error memory cleaning status system info 4 Message button Allows retrieval of information warnings and alarms 3 maximum Operating mode Status indicator Dialysate flow Status Blood flow Patient ID Status indicator Heparin Info 14 Menu buttons 9 UF Timer I O Mes...

Page 41: ...yed only if BPM option is available 12 Options menus Via the OPTIONS menu button it is possible to program up to four option menus with direct access 13 HEPARIN displayed only if selected in the Operator Setup 14 Menu buttons Corresponding menu opens automatically during operation OR touch button for opening the respective menu 15 Menu section In the center of the screen the appropriate data for e...

Page 42: ...er I O indicator TREATMENT button GREY Not active Example Emergency menu I O indicator Selection not possible Example CLEANING button The fields in the header bar are Grey in the normal operating mode Orange during the functional test T1 test Orange during rinse procedure of the extracorporeal blood circuit until the minimum rinse volume has been reached Yellow during the cleaning programs ...

Page 43: ... treatment 9 menu buttons in 3 D design are placed at the bottom screen bar representing the chronological course of operation The change to the corresponding menus is performed automatically when the respective conditions have been fulfilled Exception DIALYSATE MENU UF MENU OPTIONS and SYSTEM ...

Page 44: ...08 OP 5 09 06 O Design of the menu structure Treatment data may be changed directly on the main screen Touching the OK button accepts changed data To enter data for more parameters touch this OK level button to accept the changed data and to open the respective menu ...

Page 45: ...meric keypad for example setting the prescribed Na 1 Touch the Prescr Na field 2 Enter the desired prescribed Na via the keypad Check the entered value prescribed value Grey keys prevent implausible entries 3 Touch the OK button to accept the entered value Visually check the accepted value 4 Touch the C button for making corrections 1 4 2 3 ...

Page 46: ...eld 2 a Adjustment of window width left b Adjustment of window position right 3 Adjust the desired alarm window via the rocker switch Check the entered alarm window value in the venous pressure display prescribed value 4 Touch the OK button to accept the selected alarm window Visually check the accepted alarm window 5 Touch the C button for making corrections 1 3 2a 2b 4 5 ...

Page 47: ...ressure Only if the BPM system option exists the BVM rate and under UF goal the maximum UF goal as well as the minimum UF goal Only if the BVM system option exists It is only displayed during the treatment following a certain timed delay after the last screen action Timed delay adjustable in the Operator setup The SCREEN SAVER disappears when any part of the screen is touched The SCREEN SAVER disa...

Page 48: ...Chapter 4 Graphical User Interface 4 10 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 49: ...Fold Out Sheet 5 Preparation Fresenius Medical Care 5008 OP 5 09 06 ...

Page 50: ...Connecting the concentrate container e g acid PREPARATION SCREEN Connecting the bag e g bibag BLOOD SYSTEM SCREEN PREPARATION SCREEN DIALYSATE SCREEN UF SCREEN HEPARIN SCREEN ...

Page 51: ...n Establish the water and power supply Press the On Off key Turn the hemodialysis system on The On Off LED is illuminated START UP SCREEN The display shows the machine type the current software version and the clinical data on request for approx 15 seconds If necessary check the hemodialysis system for presence of residual disinfectant see chapter 8 Cleaning Caution The stability of the 5008 hemod...

Page 52: ... damage and excludes any warranty for damage to the system resulting from the use of non approved or unsuitable consumables or accessories Caution The symbols printed on the packaging of the consumables have to be observed The symbols are described in the chapter System Description consumables symbols When using consumables it is important to take note of the following symbols Do not reuse Use by ...

Page 53: ...sis Bicarbonate dry concentrate bibag Only the bibag manufactured by Fresenius Medical Care may be used The bibag must only be used for one treatment Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution Other mixing ratios may lead to a hazard for the patient Acid and basic bicarbonate hemodialysis concentrate have to be diluted imme...

Page 54: ...e concentrate suction tube red into the acetate container The bicarbonate suction tube blue remains in the rinse chamber Selecting a treatment SELECTION SCREEN Touch the Treatment field If there is no tubing system inserted the system automatically moves to the BLOOD SYSTEM screen BLOOD SYSTEM SCREEN The T1 test is now running in parallel with the preparation of the hemodialysis system The color o...

Page 55: ... in case of pressure fluctuations If a hydrophobic filter has become wet the tubing system must be replaced On tubing systems with additional connection sites a replacement pressure line may be connected accessory available from Fresenius Medical Care The blood in the pressure line must not be forced back by means of a syringe This could damage the hydrophobic membrane and thus lead to a contamina...

Page 56: ...t label of the blood lines If a wrong line diameter is set this may cause significant deviations in the blood flow and thus in the dialysis dose Materials which come directly or indirectly into contact with blood are Plasticized PVC unplasticized PVC polyethylene polycarbonate latex free rubber ABS The minimum temperature of the tubing systems during use is 18 C Caution Delivery operation of the p...

Page 57: ... of the hemodialysis system and the extracorporeal blood circuit Pay particular attention to the venous insertion site as a possible dislocation of the venous cannula may not always be detected by the pressure monitoring system The tubing system for leakages or possible loosening of connections as well as entry of air The fluid level in the venous bubble catcher Correct it if required desired leve...

Page 58: ...od pump until a signal is sounded The arterial pressure measurement unit is opened After closing the doors the pump segment will be automatically inserted into the blood pump 2 Insert the arterial blood line into the line holder 3 Connect the arterial blood line to the lower port of the dialyzer 4 Insert the arterial pressure dome into the arterial pressure measurement unit 5 Insert the arterial b...

Page 59: ...ous blood line to the upper port of the dialyzer 12 Connect the venous pressure line to the venous pressure connector Inserting the lines may be continued only after successful completion of the T1 test 13 Insert the SafeLine line guide into the substituate pump until a signal is sounded After closing the doors the SafeLine pump segment will be automatically inserted into the substituate pump 14 I...

Page 60: ...f a tight closure push in the substituate catch blue 17 To insert the rinse connector connected onto the venous patient line into the rinse port The catch for the rinse port grey is in initial position a Pull and turn the rinse port catch grey counterclockwise into position b Push the rinse connector firmly into the rinse port Pull and turn the rinse port catch grey clockwise until it clicks into ...

Page 61: ...se volume Check set the delivery rate of the blood pump The rinse volume and the delivery rate are automatically set to the value preselected in the Operator Setup Change the rinse volume and the delivery rate if necessary Touch the Blood pump I O button Blood pump I O indicator green O Interrupting the Rinse procedure PREPARATION SCREEN Touch the Blood pump I O button Blood pump I O indicator gre...

Page 62: ...s de activated when the treatment starts After completion of the T1 test the EcoFlow 100 ml min is automatically selected The flow can be changed as desired In the DIALYSATE MENU Check the dialysate parameters Set the desired parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 1 9 C...

Page 63: ...time or the UF goal and the UF rate must always be programmed The ISO data goal and time cannot be higher than the UF goal time The UF goal UF time or UF goal UF rate parameters must first be entered Set the desired parameters Touch the OK button to confirm the entered values Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 1 10 Checking S...

Page 64: ...ues Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN O UF profiles In the UF MENU Check the UF parameters Minimum UF parameters that can be set Profiles 1 2 UF goal 200 ml UF time 2 00 hrs UF rate 10 ml Profile 3 UF goal 200 ml UF time 3 30 hrs UF rate 10 ml Set the desired profile Check set the start rate The minimum profile rate is automat...

Page 65: ...rs In the HEPARIN menu Check the heparin pump parameters Set the desired parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN Caution Administer the heparin dose according to the physician s instructions ...

Page 66: ...Chapter 5 Preparation 5 16 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 67: ...D is illuminated START UP SCREEN The display shows the machine type the current software version and the clinical data on request for approx 15 seconds If necessary check the hemodialysis system for presence of residual disinfectant see chapter 8 Cleaning Caution The stability of the 5008 hemodialysis system must be ensured Caution After a downtime of more than 72 hours a cleaning program must be ...

Page 68: ... damage and excludes any warranty for damage to the system resulting from the use of non approved or unsuitable consumables or accessories Caution The symbols printed on the packaging of the consumables have to be observed The symbols are described in the chapter System Description consumables symbols When using consumables it is important to take note of the following symbols Do not reuse Use by ...

Page 69: ...ysis Bicarbonate dry concentrate bibag Only the bibag manufactured by Fresenius Medical Care may be used The bibag must only be used for one treatment Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution Other mixing ratios may lead to a hazard for the patient Acid and basic bicarbonate hemodialysis concentrate have to be diluted imm...

Page 70: ...e concentrate suction tube red into the acetate container The bicarbonate suction tube blue remains in the rinse chamber Selecting a treatment SELECTION SCREEN Touch the Treatment field If there is no tubing system inserted the system automatically moves to the BLOOD SYSTEM screen BLOOD SYSTEM SCREEN The T1 test is now running in parallel with the preparation of the hemodialysis system The color o...

Page 71: ... in case of pressure fluctuations If a hydrophobic filter has become wet the tubing system must be replaced On tubing systems with additional connection sites a replacement pressure line may be connected accessory available from Fresenius Medical Care The blood in the pressure line must not be forced back by means of a syringe This could damage the hydrophobic membrane and thus lead to a contamina...

Page 72: ...ct label of the blood lines If a wrong line diameter is set this may cause significant deviations in the blood flow and thus in the dialysis dose Materials which come directly or indirectly into contact with blood are Plasticized PVC unplasticized PVC polyethylene polycarbonate latex free rubber ABS The minimum temperature of the tubing systems during use is 18 C Caution Delivery operation of the ...

Page 73: ...n of the hemodialysis system and the extracorporeal blood circuit Pay particular attention to the venous insertion site as a possible dislocation of the venous cannula may not always be detected by the pressure monitoring system The tubing system for leakages or possible loosening of connections as well as entry of air The fluid level in the venous bubble catcher Correct it if required desired lev...

Page 74: ...he arterial pressure measurement unit is opened After closing the doors the pump segment will be automatically inserted into the blood pump 2 Insert the arterial blood line into the line holder 3 Connect the arterial blood line to the lower port of the dialyzer 4 Insert the arterial pressure dome into the arterial pressure measurement unit 5 Insert the arterial blood line into the arterial occlusi...

Page 75: ...e venous blood line to the upper port of the dialyzer 13 Connect the venous pressure line to the venous pressure connector 14 Connect the venous patient connection of the tubing system to the prime collection bag Prime collection bag not included in scope of delivery of the tubing system Close the doors The line segment s are automatically inserted the arterial pressure measurement unit closes Bre...

Page 76: ...ure PREPARATION SCREEN Check set the rinse volume Check set the delivery rate of the blood pump The rinse volume and the delivery rate are automatically set to the value preselected in the Operator Setup Change the rinse volume and the delivery rate if necessary Touch the Blood pump I O button Blood pump I O indicator green O Interrupting the Rinse procedure PREPARATION SCREEN Touch the Blood pump...

Page 77: ...dicator green 5 2 8 Checking Setting the Dialysate Parameters The Prescr Bic can be reduced to 25 0 mmol l during preparation adjustable in the Technician s Setup If the Bic reduction is selected 25 0 mmol l appears below the value Prescr Bic The Bic reduction is de activated when the treatment starts After completion of the T1 test the EcoFlow 100 ml min is automatically selected The flow can be ...

Page 78: ...onsideration In case of a combination with UF and Na profiles first enter the ISO UF parameters Then set the respective profiles The total volume to be removed UF goal the total treatment time UF time or the UF goal and the UF rate must always be programmed The ISO data goal and time cannot be higher than the UF goal time The UF goal UF time or UF goal UF rate parameters must first be entered Set ...

Page 79: ...ger possible to alter the Concentrate Prescr Na and Prescr Bic parameters The minimum UF time must be set Profiles 1 2 UF time 2 00 hrs Profile 3 UF time 3 30 hrs Set the desired parameters Touch the OK button to confirm the entered values Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN O UF profiles In the UF MENU Check the UF parameters M...

Page 80: ...ers may be selected only before starting or after ending a profile Set the desired parameters Touch the OK button to confirm the entered values Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 2 11 Checking Setting the Heparin Pump Parameters In the HEPARIN menu Check the heparin pump parameters Set the desired parameters Touch the OK butt...

Page 81: ...em On Establish the water and power supply Press the On Off key Turn the hemodialysis system on The On Off LED is illuminated START UP SCREEN The display shows the machine type the current software version and the clinical data on request for approx 15 seconds If necessary check the hemodialysis system for presence of residual disinfectant see chapter 8 Cleaning Caution The stability of the 5008 h...

Page 82: ... damage and excludes any warranty for damage to the system resulting from the use of non approved or unsuitable consumables or accessories Caution The symbols printed on the packaging of the consumables have to be observed The symbols are described in the chapter System Description consumables symbols When using consumables it is important to take note of the following symbols Do not reuse Use by ...

Page 83: ...ysis Bicarbonate dry concentrate bibag Only the bibag manufactured by Fresenius Medical Care may be used The bibag must only be used for one treatment Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution Other mixing ratios may lead to a hazard for the patient Acid and basic bicarbonate hemodialysis concentrate have to be diluted imm...

Page 84: ...e concentrate suction tube red into the acetate container The bicarbonate suction tube blue remains in the rinse chamber Selecting a treatment SELECTION SCREEN Touch the Treatment field If there is no tubing system inserted the system automatically moves to the BLOOD SYSTEM screen BLOOD SYSTEM SCREEN The T1 test is now running in parallel with the preparation of the hemodialysis system The color o...

Page 85: ... in case of pressure fluctuations If a hydrophobic filter has become wet the tubing system must be replaced On tubing systems with additional connection sites a replacement pressure line may be connected accessory available from Fresenius Medical Care The blood in the pressure line must not be forced back by means of a syringe This could damage the hydrophobic membrane and thus lead to a contamina...

Page 86: ...ct label of the blood lines If a wrong line diameter is set this may cause significant deviations in the blood flow and thus in the dialysis dose Materials which come directly or indirectly into contact with blood are Plasticized PVC unplasticized PVC polyethylene polycarbonate latex free rubber ABS The minimum temperature of the tubing systems during use is 18 C Caution Delivery operation of the ...

Page 87: ...n of the hemodialysis system and the extracorporeal blood circuit Pay particular attention to the venous insertion site as a possible dislocation of the venous cannula may not always be detected by the pressure monitoring system The tubing system for leakages or possible loosening of connections as well as entry of air The fluid level in the venous bubble catcher Correct it if required desired lev...

Page 88: ...tomatically inserted into the blood pump 2 Connect the SN pressure line to the Single Needle pressure port 3 Insert the SN chamber in its holder 4 Insert the SN line guide into the Single Needle pump until a signal is sounded After closing the doors the SN pump segment is automatically inserted in the Single Needle pump if the level detector detected fluid 5 Connect the arterial blood line to the ...

Page 89: ...enous blood line to the upper port of the dialyzer 14 Connect the venous pressure line to the venous pressure connector Inserting the lines may be continued only after successful completion of the T1 test 15 Insert the SafeLine line guide into the substituate pump until a signal is sounded After closing the doors the SafeLine pump segment will be automatically inserted into the substituate pump 16...

Page 90: ...f a tight closure push in the substituate catch blue 19 To insert the rinse connector connected onto the venous patient line into the rinse port The catch for the rinse port grey is in initial position a Pull and turn the rinse port catch grey counterclockwise into position b Push the rinse connector firmly into the rinse port Pull and turn the rinse port catch grey clockwise until it clicks into ...

Page 91: ...se volume Check set the delivery rate of the blood pump The rinse volume and the delivery rate are automatically set to the value preselected in the Operator Setup Change the rinse volume and the delivery rate if necessary Touch the Blood pump I O button Blood pump I O indicator green O Interrupting the Rinse procedure PREPARATION SCREEN Touch the Blood pump I O button Blood pump I O indicator gre...

Page 92: ...s de activated when the treatment starts After completion of the T1 test the EcoFlow 100 ml min is automatically selected The flow can be changed as desired In the DIALYSATE MENU Check the dialysate parameters Set the desired parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 3 9 C...

Page 93: ...time or the UF goal and the UF rate must always be programmed The ISO data goal and time cannot be higher than the UF goal time The UF goal UF time or UF goal UF rate parameters must first be entered Set the desired parameters Touch the OK button to confirm the entered values Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 3 10 Checking S...

Page 94: ...ues Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN O UF profiles In the UF MENU Check the UF parameters Minimum UF parameters that can be set Profiles 1 2 UF goal 200 ml UF time 2 00 hrs UF rate 10 ml Profile 3 UF goal 200 ml UF time 3 30 hrs UF rate 10 ml Set the desired profile Check set the start rate The minimum profile rate is automat...

Page 95: ...the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 3 12 Checking Setting the Single Needle Parameters In the SINGLE NEEDLE menu Check the Single Needle parameters Set the desired parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN Caution Admi...

Page 96: ...Chapter 5 Preparation 5 46 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 97: ... On Off LED is illuminated START UP SCREEN The display shows the machine type the current software version and the clinical data on request for approx 15 seconds If necessary check the hemodialysis system for presence of residual disinfectant see chapter 8 Cleaning Caution The stability of the 5008 hemodialysis system must be ensured Caution After a downtime of more than 72 hours a cleaning progra...

Page 98: ... damage and excludes any warranty for damage to the system resulting from the use of non approved or unsuitable consumables or accessories Caution The symbols printed on the packaging of the consumables have to be observed The symbols are described in the chapter System Description consumables symbols When using consumables it is important to take note of the following symbols Do not reuse Use by ...

Page 99: ...ysis Bicarbonate dry concentrate bibag Only the bibag manufactured by Fresenius Medical Care may be used The bibag must only be used for one treatment Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution Other mixing ratios may lead to a hazard for the patient Acid and basic bicarbonate hemodialysis concentrate have to be diluted imm...

Page 100: ...e concentrate suction tube red into the acetate container The bicarbonate suction tube blue remains in the rinse chamber Selecting a treatment SELECTION SCREEN Touch the Treatment field If there is no tubing system inserted the system automatically moves to the BLOOD SYSTEM screen BLOOD SYSTEM SCREEN The T1 test is now running in parallel with the preparation of the hemodialysis system The color o...

Page 101: ... in case of pressure fluctuations If a hydrophobic filter has become wet the tubing system must be replaced On tubing systems with additional connection sites a replacement pressure line may be connected accessory available from Fresenius Medical Care The blood in the pressure line must not be forced back by means of a syringe This could damage the hydrophobic membrane and thus lead to a contamina...

Page 102: ...ct label of the blood lines If a wrong line diameter is set this may cause significant deviations in the blood flow and thus in the dialysis dose Materials which come directly or indirectly into contact with blood are Plasticized PVC unplasticized PVC polyethylene polycarbonate latex free rubber ABS The minimum temperature of the tubing systems during use is 18 C Caution Delivery operation of the ...

Page 103: ...n of the hemodialysis system and the extracorporeal blood circuit Pay particular attention to the venous insertion site as a possible dislocation of the venous cannula may not always be detected by the pressure monitoring system The tubing system for leakages or possible loosening of connections as well as entry of air The fluid level in the venous bubble catcher Correct it if required desired lev...

Page 104: ...pump 2 Connect the SN pressure line to the Single Needle pressure port 3 Insert the SN chamber in its holder 4 Insert the SN line guide into the Single Needle pump until a signal is sounded After closing the doors the SN pump segment is automatically inserted in the Single Needle pump if the level detector detected fluid 5 Connect the arterial blood line to the lower port of the dialyzer 6 Insert ...

Page 105: ...he venous blood line to the upper port of the dialyzer 15 Connect the venous pressure line to the venous pressure connector 16 Connect the venous patient connection of the tubing system to the prime collection bag Prime collection bag not included in scope of delivery of the tubing system Close the doors The line segment s are automatically inserted the arterial pressure measurement unit closes Br...

Page 106: ...ure PREPARATION SCREEN Check set the rinse volume Check set the delivery rate of the blood pump The rinse volume and the delivery rate are automatically set to the value preselected in the Operator Setup Change the rinse volume and the delivery rate if necessary Touch the Blood pump I O button Blood pump I O indicator green O Interrupting the Rinse procedure PREPARATION SCREEN Touch the Blood pump...

Page 107: ...dicator green 5 4 8 Checking Setting the Dialysate Parameters The Prescr Bic can be reduced to 25 0 mmol l during preparation adjustable in the Technician s Setup If the Bic reduction is selected 25 0 mmol l appears below the value Prescr Bic The Bic reduction is de activated when the treatment starts After completion of the T1 test the EcoFlow 100 ml min is automatically selected The flow can be ...

Page 108: ...onsideration In case of a combination with UF and Na profiles first enter the ISO UF parameters Then set the respective profiles The total volume to be removed UF goal the total treatment time UF time or the UF goal and the UF rate must always be programmed The ISO data goal and time cannot be higher than the UF goal time The UF goal UF time or UF goal UF rate parameters must first be entered Set ...

Page 109: ...ger possible to alter the Concentrate Prescr Na and Prescr Bic parameters The minimum UF time must be set Profiles 1 2 UF time 2 00 hrs Profile 3 UF time 3 30 hrs Set the desired parameters Touch the OK button to confirm the entered values Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN O UF profiles In the UF MENU Check the UF parameters M...

Page 110: ...lly check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 4 11 Checking Setting the Heparin Pump Parameters In the HEPARIN menu Check the heparin pump parameters Set the desired parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the PREPARATION menu button to return to the PREPARATION SCREEN 5 4 12 Che...

Page 111: ...Fold Out Sheet 6 Treatment Fresenius Medical Care 5008 OP 5 09 06 ...

Page 112: ...TREATMENT SCREEN SN setting the level in the SN chamber ...

Page 113: ...terial tubing system from the SafeLine Connect the SafeLine before predilution or below the dialyzer postdilution Connect the arterial line to the patient Remove the rinse connector Disconnect the venous tubing system from the rinse connector and connect it to the patient or if desired to a separate prime collection bag Close the rinse port Message Start the blood pump Confirm Touch the Confirm bu...

Page 114: ...ouch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN 6 1 3 ONLINEplus Bolus Administration Touch the ONLINE menu button Check the bolus parameters Set the desired bolus parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the Bolus I O button to turn t...

Page 115: ...ate parameters Set the desired dialysate parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN 6 1 5 Changing the UF Parameters It is not necessary to touch the UF Timer I O button before or after changing the UF parameters In the UF MENU How to change UF parameters Set the desired UF param...

Page 116: ...and Na profile were stopped Both profiles Abort UF profile Abort Treatment Continue Touch the desired button If no button is touched the profiles will be stopped for a certain time adjustable in the Operator setup 6 1 7 Changing the Heparin Pump Parameters In the HEPARIN menu Touch the Heparin I O button to turn the heparin pump on or off How to change heparin pump parameters Set the desired hepar...

Page 117: ...etected Dialysis Start The blood pump stops The arterial venous occlusion clamp closes Mute LED is flashing Connect the venous connector of the tubing system to the patient provided this has not been done yet Touch the Start button The system automatically changes to the TREATMENT SCREEN Heparin pump and ultrafiltration are started automatically if preset in the Operator Setup Set the blood flow t...

Page 118: ...parameters In the UF MENU How to change UF parameters Set the desired UF parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN During the treatment it is possible to increase the maximum possible UF rate in the Operator setup 6 2 4 Sodium and UF Profiles If sodium or UF profiles are program...

Page 119: ...rin pump on or off How to change heparin pump parameters Set the desired heparin pump parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN 6 2 6 Administering Infusion Solutions Message No blood detected Dialysis Continue Reinfusion Start Machine Remove lines The blood pump stops The arter...

Page 120: ...Chapter 6 Treatment 6 8 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 121: ...nnect Continue Touching the Continue button will continue the previously activated procedure Single Needle Connect Touch the Single Needle Connect button Disconnect the arterial tubing system from the SafeLine Connect the SafeLine before predilution or below the dialyzer postdilution Connect the arterial line to the patient Remove the rinse connector Disconnect the venous tubing system from the ri...

Page 122: ...pump may also be started in advance by touching the Sub pump I O button The substituate pump will be stopped in the event of a blood or a dialysate alarm Standard Connect Touch the Standard Connect button Disconnect the arterial tubing system from the SafeLine Connect the SafeLine before predilution or below the dialyzer postdilution Connect the arterial line to the patient Remove the rinse connec...

Page 123: ... delivery rate The alarm limits will be set automatically The substituate pump will start automatically after approx 3 minutes The substituate pump may also be started in advance by touching the Sub pump I O button The substituate pump will be stopped in the event of a blood or a dialysate alarm 6 3 2 Changing the ONLINEplus Parameters In the ONLINE menu Touch the Sub pump I O button to turn the s...

Page 124: ...e Single Needle Parameters In the SINGLE NEEDLE menu If you wish to alter Single Needle parameters Set the desired Single Needle parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN 6 3 5 Setting the Level in the SN Chamber In the BLOOD SYSTEM menu Touch the VW button on the Single Needle ...

Page 125: ...dle mode 6 3 7 Starting SN during the Treatment In the SINGLE NEEDLE menu Touch the Single Needle I O button Blood pump I O indicator green Message Connect both the arterial and the venous patient line to the same vascular access Single Needle Start Abort Touch the Start button The Single Needle line segment is automatically inserted in the Single Needle pump Message Set the level in the SN chambe...

Page 126: ... desired UF parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN During the treatment it is possible to increase the maximum possible UF rate in the Operator setup 6 3 10 Sodium and UF Profiles If sodium or UF profiles are programmed during the treatment they will start with a delay time o...

Page 127: ... setup 6 3 11 Changing the Heparin Pump Parameters In the HEPARIN menu Touch the Heparin I O button to turn the heparin pump on or off How to change heparin pump parameters Set the desired heparin pump parameters Touch the OK button to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN ...

Page 128: ...Chapter 6 Treatment 6 16 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 129: ...ly activated procedure Single Needle Connect Connect the arterial and venous lines to the patient Touch the Single Needle Connect button Message Start the blood pump Confirm Touch the Confirm button Message Set the level in the SN chamber to the mark V Level W Level set OK Abort Touch the V or W button to set the level to the mark of the SN chamber holder The doors must be closed Touch the OK butt...

Page 130: ...ptical detector sensed blood Message Blood detected Double Needle dialysis Start Single Needle dialysis Start The blood pump stops The arterial venous occlusion clamp closes Mute LED is flashing Connect the venous connector of the tubing system to the patient provided this has not been done yet Touch the Double Needle dialysis Start button Caution When using high flux dialyzers and selecting low U...

Page 131: ...tton to confirm the values entered Visually check the confirmed values Touch the TREATMENT menu button to return to the TREATMENT SCREEN 6 4 3 Setting the Level in the SN Chamber In the BLOOD SYSTEM menu Touch the VW button on the Single Needle chamber displayed on the screen Message Set the level in the SN chamber to the mark V Level W Level set OK Abort Touch the V or W button to set the level t...

Page 132: ...ingle Needle Start Abort Touch the Start button The Single Needle line segment is automatically inserted in the Single Needle pump Message Set the level in the SN chamber to the mark V Level W Level set OK Abort Touch the V or W button to set the level to the mark of the SN chamber holder The doors must be closed Touch the OK button 6 4 6 Changing the Dialysate Parameters In the DIALYSATE MENU Tou...

Page 133: ...tup 6 4 8 Sodium and UF Profiles If sodium or UF profiles are programmed during the treatment they will start with a delay time of 20 seconds O Starting Automatically if OD dark adjustable in the Operator setup Touch the UF timer I O button O Stopping aborting Touch the UF timer I O button Message UF profile and Na profile were stopped Both profiles Abort UF profile Abort Treatment Continue Touch ...

Page 134: ...nu button to return to the TREATMENT SCREEN 6 4 10 Administering Infusion Solutions Message No blood detected Dialysis Continue Reinfusion Start Machine Remove lines The blood pump stops The arterial venous occlusion clamp closes Mute LED is flashing Audible signal Touch the Continue button to go on with the dialysis treatment Note When administering infusion solutions e g saline the blood may be ...

Page 135: ...Fold Out Sheet 7 Reinfusion Fresenius Medical Care 5008 OP 5 09 06 ...

Page 136: ...REINFUSION SCREEN ...

Page 137: ...ge Treatment goal achieved Dialysis Continue Reinfusion Start Mute LED is flashing Audible signal Touch the Start button The system switches automatically to the REINFUSION SCREEN Perform a reinfusion Aborting treatment with Reinfusion program Touch the REINFUSION menu button REINFUSION SCREEN Touch the Reinfusion I O button Perform a reinfusion O Performing reinfusion REINFUSION SCREEN Message ON...

Page 138: ...le signal Touch the Remove lines button Message Blood lines will be removed automatically Please wait the doors must be closed The line segment is removed Then the arterial pressure measurement unit will be opened Message Please open the doors to continue Open the doors Message Please remove the blood lines completely and close the doors 7 1 2 Emptying the Dialyzer Message Please insert the dialyz...

Page 139: ... Operator Setup setting Touch the DIALYSATE MENU menu button Touch the Empty bags field Touch the bibag field and accept with the OK button The drain program is in progress Message The bibag is empty and it can now be removed or Empty bibag Repeat Remove the bibag Close the bicarbonate flap 7 1 4 Removing the Blood Lines Remove the blood lines Close the doors Note Always clean the sealing area of ...

Page 140: ...Chapter 7 Reinfusion 7 4 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 141: ...erform a reinfusion Aborting treatment with Reinfusion program Touch the REINFUSION menu button REINFUSION SCREEN Touch the Reinfusion I O button Perform a reinfusion O Performing reinfusion REINFUSION SCREEN Message Connect a bag of NaCl Start reinfusion OK Treatment The blood pump stops The arterial venous occlusion clamp closes Mute LED is illuminated Audible signal Disconnect the arterial pati...

Page 142: ...essage Please open the doors to continue Open the doors Message Please remove the blood lines completely and close the doors 7 2 2 Emptying the Dialyzer Message Please insert the dialyzer coupling into the shunt interlock to empty the dialyzer Turn the dialyzer The dialysate inlet port must be at the upper end Open the shunt door Place the dialysate supply line red on the red color coded position ...

Page 143: ...ove the bibag Close the bicarbonate flap 7 2 4 Removing the Blood Lines Remove the blood lines Close the doors Note Always clean the sealing area of the connector after dialysis to remove bicarbonate precipitate Caution Discard the extracorporeal blood circuit after the treatment Observe the regulations for the handling of potentially contaminated materials Caution It is imperative to disinfect th...

Page 144: ...Chapter 7 Reinfusion 7 8 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 145: ... the UF goal or aborting treatment with reinfusion program are described in the chapters mentioned below see chapter 7 1 page 7 1 7 4 Single Needle Option Reinfusion with Rinse Solution Bag The procedures for end of treatment after achieving the UF goal or aborting treatment with reinfusion program are described in the chapters mentioned below see chapter 7 2 page 7 5 ...

Page 146: ...Chapter 7 Reinfusion 7 10 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 147: ...Fold Out Sheet 8 Cleaning Fresenius Medical Care 5008 OP 5 09 06 ...

Page 148: ...Connecting the disinfectant container CLEANING SCREEN Program run graphic e g Diasteril ...

Page 149: ...d The bicarbonate suction tube blue is connected to the rinse chamber The bicarbonate flap is closed The indibag flap must be closed The optical detector does not sense blood Only with ONLINEplus The substituate port and the rinse port must be closed Any failure to comply with the basic requirements will be indicated by a message on the display Caution Contact of the DIASAFE plus with organic solv...

Page 150: ...ctions for use When connecting the disinfectant container also observe the following criteria The containers must be provided with a ventilation opening The coding of the disinfection connectors The disinfectant must match the respective disinfection program Different disinfectants may not be mixed with each other Prior to the use of disinfectants other than those listed in chapter 12 Consumables ...

Page 151: ...ONLINEplus if the door of the dialysate filter chamber is open Substituate port and rinse port only with ONLINEplus These risks can be present as long as the respective cleaning program is not yet completed Note Flow alarms during cleaning programs will increase the length of the cleaning program at least by the time of the alarm The count down times shown during the cleaning programs are calculat...

Page 152: ...l then be displayed Caution Do not turn the hemodialysis system off with the On Off monitor key while a cleaning program is in progress If the hemodialysis system has to be turned off during a cleaning program due to a technical defect press the On Off monitor key for approx 5 seconds Caution After a disinfection program has been aborted or if the system is to be preserved the hemodialysis system ...

Page 153: ... Monitor Symbol button for approx 3 seconds The screen will be frozen After cleaning the screen Touch the Monitor Symbol button for approx 1 second Normal screen operation is restored The screen will be unfrozen if a warning or an alarm occurs Caution Following a disinfection the system must be checked for presence of residual disinfectant e g for Puristeril 340 Puristeril plus potassium iodide st...

Page 154: ...upply Automatic turn off of the hemodialysis system on completion of the cleaning program While a cleaning program is performed the Auto Off field is displayed The Auto Off field is a toggle field Auto Off toggled off Auto Off Time after which the machine will turn itself off programmable in the Technician s Setup If a time has been defined for Auto Off the hemodialysis system will turn itself off...

Page 155: ...Fold Out Sheet 9 Alarm processing Fresenius Medical Care 5008 OP 5 09 06 ...

Page 156: ...Informational message Manually opening the arterial pressure measurement unit Warning message Alarm message Info window at the top opened Flipping the handle outward ...

Page 157: ...dentification purposes the BPM option is provided with a separate audible warning tone Up to 3 messages can be filed in the Message button Touch the X button to file the messages To retrieve the messages touch the Message button If several messages are displayed select the desired message The windows contain a brief description of the condition for the operator and the required instructions to cor...

Page 158: ...rved When removing air the instructions displayed by the hemodialysis system must be strictly followed The operator is responsible that the instructions are carried out correctly In addition detailed descriptions can be displayed in the associated Info window by touching the button If the venous pressure is 100 mmHg it must be reduced on the venous bubble catcher using a syringe until the system d...

Page 159: ...08 OP 5 09 06 9 3 O Air removal procedure Alarm message Info window can be displayed by touching the button Follow the instructions Touch the Confirm button Alarm message Safety prompt After the instructions have been carried out Touch the Confirm button ...

Page 160: ...e Will only be displayed if the venous pressure is 100 mmHg Info window can be displayed by touching the button The next message will automatically be displayed if the venous pressure is 100 mmHg Informational message Info window can be displayed by touching the button Touch the Start button ...

Page 161: ...y stop after 200 ml If no air is present in the system the blood pump can also be stopped before this volume is reached by touching the Stop button Informational message Touch the Yes button if all air has been removed from the venous tubing system Touch the No button if air is still present in the venous tubing system Automatically the previous info message is then displayed ...

Page 162: ...Care 5008 OP 5 09 06 Informational message Info window can be displayed by touching the button Follow the instructions Touch the Continue button The blood pump will start with the delivery rate displayed Check the delivery rate and change if necessary ...

Page 163: ...uctions must be observed When removing air the instructions displayed by the hemodialysis system must be strictly followed The operator is responsible that the instructions are carried out correctly In addition detailed descriptions can be displayed in the associated Info window by touching the button If the venous pressure is 100 mmHg it must be reduced on the venous bubble catcher using a syring...

Page 164: ...etected below the venous bubble catcher Alarm message Info window can be displayed by touching the button Touch the Continue button and observe the following section Overriding the Micro bubbles alarm message OR Touch the Confirm button and observe the following section Micro bubbles removal procedure ...

Page 165: ...Continue button if no micro bubbles are detected It is possible to override the alarm messages 5 times only during a treatment using the Continue button If micro bubbles continue to be detected remove the air as described in the chapter mentioned below see chapter 9 2 page 9 2 Micro bubbles will be displayed in the Message button field The alarm message will be overridden for the time set in the T...

Page 166: ...ro bubbles removal procedure Alarm message Info window can be displayed by touching the button Follow the instructions Touch the Confirm button Then follow the further instructions Alarm message Safety prompt After the instructions have been carried out Touch the Confirm button ...

Page 167: ...e Will only be displayed if the venous pressure is 100 mmHg Info window can be displayed by touching the button The next message will automatically be displayed if the venous pressure is 100 mmHg Informational message Info window can be displayed by touching the button Touch the Start button ...

Page 168: ...y stop after 200 ml If no air is present in the system the blood pump can also be stopped before this volume is reached by touching the Stop button Informational message Touch the Yes button if all air has been removed from the venous tubing system Touch the No button if air is still present in the venous tubing system Automatically the previous info message is then displayed ...

Page 169: ...5008 OP 5 09 06 9 13 Informational message Info window can be displayed by touching the button Follow the instructions Touch the Continue button The blood pump will start with the delivery rate displayed Check the delivery rate and change if necessary ...

Page 170: ...eak O Dimness warning Message Blood leak detector dimness warning Desired 2000 mV Actual XXXX mV Confirm Cause Blood leak detector detects dimness Dialysate side primed in dialysis mode High deaeration caused by high ultrafiltration rate Dialysate drain line not tightly connected Grease or calcium deposits Touch the Confirm button The dialysis treatment may be terminated in the usual manner If the...

Page 171: ...edy Verify the concentrate side Correct the problem causing the alarm 9 7 Manually Opening the Arterial Pressure Measurement Unit Relieve the pressure in the blood lines Connect a syringe to the upper left port in the dialysate filter chamber Use a syringe to open the arterial pressure measurement unit 9 8 Power Failure Outage O Power failure and battery operation In case of a power failure the fo...

Page 172: ...atient connection and connect it to the rinse solution bag Flip the handle outwards Pull out the knob on the handle tray Only rotate the handle clockwise Remove the venous patient connection line from the venous occlusion clamp Visually check the line for air Manually return the blood Remove the venous patient connection after manual blood return Close the clamps on the blood lines Manually remove...

Page 173: ...display distorted Reinfusion with rinse solution All monitoring systems are active Disconnect the arterial patient connection and connect it to the rinse solution bag Touch the Blood system Start button green Caution Touch the Blood system Stop button red The pumps will be stopped blood pump substituate pump optionally Single Needle pump Emergency operation Perform a manual reinfusion To return th...

Page 174: ... rate will be limited to the reinfusion rate The alarm limits will be set around the actual values Perform a reinfusion Remove the venous patient connection after blood return Close the clamps on the blood lines Manually remove the blood lines Manually open the arterial pressure measurement unit ...

Page 175: ...Fold Out Sheet 10 Other Functions Fresenius Medical Care 5008 OP 5 09 06 ...

Page 176: ...SYSTEM SCREEN Collecting a sample SETUP SCREEN Operator setup Changing the DIASAFE plus Cleaning the dialysate particle filter BLOOD SYSTEM SCREEN ...

Page 177: ...EN settings Select the desired function Make changes if required Save with OK Select default values with FMC Logo O SYSTEM SCREEN settings overview Sub item Default value Value range Resolution Selectable options Date Day month year Adjustable only with ServiceCard Time 00 00 to 23 59 0 01 Brightness 0 not adjustable Loudness 6 1 to 9 1 Graphic time scale Auto The last time segments of the respect...

Page 178: ... OPERATOR SETUP menu Select the desired function Make changes if required Save with OK Select default values with FMC Logo O Blood line O Blood pump Sub item Default value Value range Resolution Selectable options Blood line AV Set 5008 Sub item Default value Value range Resolution Selectable options Pump segment 8 0 mm 8 0 mm 4 4 mm 6 4 mm Delivery rates Prime 100 ml min 30 to 600 ml min 10 ml mi...

Page 179: ...on volume 250 ml 0 to 480 ml 10 ml Sub item Default value Value range Resolution Selectable options Heparin Heparinization Yes Yes No Heparin unit I U currently not adjustable ml ml I U Heparin start Automatic Automatic Manual Hep rate 1 2 ml h 0 5 to 10 0 ml h 0 1 ml h I U currently not adjustable 10 I U h 10 to 25 000 I U h 10 I U h Stop time 0 30 0 00 to 2 00 0 01 Syringe Fresenius 30 ml Depend...

Page 180: ... 30 ml B Braun 20 ml B Braun 30 ml B D 20 ml B D 30 ml JMS 20 ml Nipro 20 ml Safti 20 ml Terumo 20 ml Terumo 30 ml Parameter Displays the parameters of the selected syringe Currently not active By means of the following list define own syringe types in the Syringe types list by touching the New syringe button see the following heparin pump illustration Syringe name Diameter 1 Internal diameter 10 ...

Page 181: ...erator Setup Define concentrates SK F 203 Depending on Operator Setup Define concentrates Prescr Na 138 mmol l 125 to 160 mmol l 1 mmol l Prescr Bic 32 0 mmol l 0 to 40 0 mmol l 1 mmol l Flow 500 ml min 100 to 1000 ml min 100 ml min Auto flow Yes Yes No Factor 1 5 1 0 to 2 0 0 1 Temperature 36 5 C 34 C to 39 C 0 5 C Bags Empty bibag Automatic Automatic If optical detector does not sense blood Manu...

Page 182: ...119 2 SK F 113 1 SK F 118 SK F 109 SK F 103 SK F 112 SK F 113 SK F 1 513 SK F 219 0 SK F 219 3 SK F 207 SK F 219 1 SK F 2129 SK F 21 56 SK F 213 4 SK F 212 1 SK F 216 1 SK F 219 SK F 21 53 SK F 209 SK F 218 1 SK F 218 SK F 202 SK F 203 SK F 212 SK F 216 SK F 213 SK F 223 SK F 212 2 SK F 2 513 SK F 318 1 SK F 313 2 SK F 301 SK F 309 SK F 311 SK F 312 1 SK F 316 SK F 313 1 SK F 318 SK F 303 SK F 313...

Page 183: ...ure is g l Component ingredients Acid A CH3COOH acetic acid or HCl hydrochloric acid is the concentration of the acid which originates from the acidic or A concentrate prior to the reaction with the bicarbonate component in case of bicarbonate dialysis it is in most cases identical with the acetate If the value set here is zero it is assumed that it is identical with acetate i e that the acetate o...

Page 184: ...arbonate dialysis specified hereafter also affect the limits which can be set by the operator Some of the expected operator adjustments may then no longer be possible Operator setting limits Whichever condition is the most stringent applies Prescr Na Concentration of the prescription 10 rounded off and 12 8 mS cm expected conductivity 15 7 mS cm and 125 mmol l prescribed Na 155 mmol l Prescr Bic C...

Page 185: ...f the components A concentrate non dimensional 1 constant B concentrate non dimensional 0 Water non dimensional 19 40 Electrolytes Na 1 mmol l 125 150 K 1 100 mmol l 0 00 5 00 Ca 1 1000 mmol l 0 00 2 500 Mg 1 100 mmol l 0 20 1 00 Cl 1 100 mmol l 80 00 126 HCO3 1 10 mmol l 0 0 CH3COO 1 100 mmol l 30 00 40 00 Other ingredients Glucose g l 0 3 Component ingredients Acid A 0 Na B 0 ...

Page 186: ...facilitates the calculation Mix 1 B concentrate parts H2O parts 20 Electrolytes Na 1 mmol l 125 150 Requirement the NaCl saline concentration in the acidic concentrate must be 1800 mmol l K 1 100 mmol l 0 00 5 00 Ca 1 1000 mmol l 0 00 2 500 Mg 1 100 mmol l 0 20 1 00 Cl 1 100 mmol l 80 00 126 HCO3 1 10 mmol l 24 0 40 0 Requirement the concentration of bicarbonate in the bicarbonate concentrate must...

Page 187: ...sodium 138 00 mmol l K potassium 2 00 mmol l Ca calcium 1 75 mmol l Mg magnesium 0 50 mmol l Cl chloride 109 50 mmol l HCO3 bicarbonate 32 00 mmol l CH3COO acetate 3 00 mmol l Other ingredients Glucose 2 00 g l Component ingredients Acid A 3 mmol l CH3COO acetate Na B 35 mmol l HCO3 bicarbonate Na in the bicarbonate A concentrate B concentrate Water The canister label of the concentrate used as an...

Page 188: ...he unit mmol l of the ready to use dialysate must be calculated based on the atomic weights Canister labeling 1 35 NaCl 210 68 g l Atomic weight NaCl Atomic weight Na 22 990 atomic weight Cl 35 453 atomic weight NaCl 58 443 Conversion NaCl from g l to mmol l NaCl 210 68 g l 35 mixing ratio 6 019 g l 6 019 g l 58 443 atomic weight NaCl 0 103 mol l 103 mmol l Entry Na Na 103 mmol l Na of NaCl 35 mmo...

Page 189: ...c If optical detector senses blood Manual UF with time rate only rate preset no time Blocked Blocked Released Free UF profile Currently not adjustable Blocked Blocked Released Max UF rate 3000 ml h 500 to 4000 ml h 10 ml h Max profile rate 3500 ml h 3010 to 4000 ml h 10 ml h Current treatment data Displays the current treatment data during the treatment Max UF rate Max profile rate ...

Page 190: ...s pressure settings Art alarm limit Centred Centred Asymmetric Art window width 100 mmHg 40 to 200 mmHg 10 mmHg Ven alarm limit Asymmetric Asymmetric Centred Ven window width 100 mmHg 40 to 200 mmHg 10 mmHg Ven window position Unlimited Unlimited 20 mmHg Lower value of the alarm limit window not adjustable below 20 mmHg Kinking warning BLK on off Yes Yes No Venous transducer WET on off Yes Yes No ...

Page 191: ...Pressure graphs BPM history UF Na diagram Pressure graphs OCM diagram BTM T control BTM rec BTM events BPM BPM MAP BPM history BVM Group 2 BPM BPM MAP See group 1 Group 3 See group 1 Group 4 See group 1 Define options Sub item Default value Value range Resolution Selectable options A maximum of 4 option buttons may be added The option buttons which have been added will appear on the lower right ab...

Page 192: ...eld size may be created Option fields can be added only if the particular option is available From the DIALYSATE MENU Concentrate Na profile Temperature Flow Auto flow Dialyzer From the UF MENU UF profile From the HEPARIN menu Hep rate Stop time Bolus Cum vol Bolus I O From the ONLINE menu Treatment mode Auto sub Sub goal Sub rate Sub pump I O HCT TP From the SINGLE NEEDLE menu Effective blood flo...

Page 193: ...ing Sub item Default value Value range Resolution Selectable options Autom cleaning pgm after treatment Yes Yes No Audible info No No Yes Auto Off 10 min 10 min 30 min 60 min No Immediately Disinfection note Message The last disinfection was performed XX hours days ago Yes Yes No ...

Page 194: ...te flap Sub item Default value Value range Resolution Selectable options Weekly programs The program and the power up time may be preselected Then turn programming on or off via Status If several programming actions have been performed it is possible to turn them all on or off via the Auto On Programs I O button Programs No program Rinse Heat disinfection Standby T1 test No program power up time 0...

Page 195: ...lectable options UF Off Yes Yes No Blood flow reduction to 100 ml min Yes Yes No Blood pressure measurement No No Yes Standard bolus activation of the bolus and bolus rate values set hereafter Yes Yes No Bolus 90 ml 90 to 240 ml 30 ml Bolus rate 200 ml min 50 to 250 ml min 10 ml min Emergency bolus Preset bolus 240 ml bolus rate blood flow before emergency 50 ml min No No Yes ...

Page 196: ... operator card Insert the patient card Message Patient card for date of birth Touch the OK button Enter the desired data for the patient After pressing the desired field enter the data using the keypad To confirm each entry of the patient data touch the OK button Visually check the confirmed patient data Touch the Create patient card button Message Saving data to card Leave card inserted Remove th...

Page 197: ...on HD HDF predilution Bolus Bolus 150 ml 90 to 240 ml 30 ml Bolus rate 200 ml min 100 to 250 ml min 10 ml min Preparation ONLINE Onl rinse vol 800 ml 500 to 5000 ml 100 ml Onl UF rinse vol If Onl UF rinse vol 0 UF rinse will not be displayed during Preparation 500 ml 0 to 5000 ml 100 ml Reinfusion ONLINE Reinfusion volume 360 ml 60 to 480 ml 60 ml Substitution Auto sub Yes Yes No Hemoconcentration...

Page 198: ...ing the Delete class button Operator list Dialyzer classes FX HighFlux F HighFlux Parameter Displays the parameters of the selected dialyzer class By means of the following list define own dialyzer classes in the Dialyzer classes list by touching the New class button Name of dialyzer class AutoSub factor Predilution 1 00 0 50 to 1 50 0 05 Postdilution 1 00 0 60 to 1 40 0 05 Sub item Default value ...

Page 199: ... to SN pump speed 20 60 to 60 5 Single Needle Click Clack SN pressure window venous pressure Width 80 to 480 mmHg maximum SN pressure 480 mmHg minimum SN pressure 20 mmHg Lower SN pressure 50 mmHg 10 mmHg Upper SN pressure 400 mmHg 10 mmHg Sub item Default value Value range Resolution Selectable options Installation place Displayed in submenu Status Device info Installation place of the 5008 hemod...

Page 200: ... 90 mmHg 1 mmHg MAP min 70 mmHg 20 to 120 mmHg 1 mmHg PULSE min 40 1 min 20 to 140 1 min 1 1 min Preselected pressure 160 mmHg 100 to 290 mmHg 1 mmHg Sub item Default value Value range Resolution Selectable options BVM Cuvette detection after turning power on Passive Passive Active Max BVM rate 2800 ml h 0 to 2800 ml h 50 ml h Hemoglobin unit g dl g dl mmol l Use OCM ONLINE measurement data Preset...

Page 201: ...ons BTM BTM Tubing detection after turning power on Active Active Passive Recirculation Recirculation measurement Automatic Automatic Manual Body temperature Temp control Automatic Automatic Manual Change rate 0 0 C h 0 5 to 0 5 C h 0 1 C h Max dialysate temperature 38 0 C 37 0 to 38 0 C 0 5 C Room temperature Room temperature Is not measured but has to be set 20 0 C 15 0 to 35 0 C 1 0 C ...

Page 202: ... occurs Touch the Emergency button Operating mode indicator is flashing yellow EMERGENCY MENU displays the preselected ONLINE bolus functions O Deactivating the Emergency button function Touch the Emergency button Operating mode indicator green in alarm free condition The status before activating the emergency function will be restored 10 4 Emptying Changing the bibag Touch the DIALYSATE MENU menu...

Page 203: ... Caution Use only the original Fresenius DIASAFE plus Caution Observe the following rules of hygiene when inserting the DIASAFE plus Only use filters with undamaged packaging Remove the packaging and the protective straps only immediately before installing the filter Only touch the connectors if required Note The CLEANING SCREEN shows when the next filter change is necessary If a cleaning program ...

Page 204: ... s has have been primed Message Disinfection required Touch the Cleaning menu button 10 6 Cleaning the Dialysate Particle Filter Turn the particle filter holder to the left 1 Pull it out slightly towards you and turn it to the right 2 Clean the dialysate particle filter Re insert the filter holder and turn it to the left then push it lightly in and turn it again to the right In this last position ...

Page 205: ... blood line Press and hold the Prime button until the arterial line has been completely primed Prime Treatment Continue Press and hold the Prime button until the arterial line has been primed Connect the arterial line to the patient and to the dialyzer Touch the Continue button 10 9 2 Removing the Venous Line In the BLOOD SYSTEM menu Touch the Remove venous line button Message Remove venous blood ...

Page 206: ...e SafeLine is being made available Message Prime the SafeLine Press and hold the Prime button until the SafeLine has been sufficiently primed Prime Exit Press and hold the Prime button until the SafeLine has been primed Touch the Exit button Depending on the selected substitution mode connect the SafeLine before or after the dialyzer and follow the corresponding message prompts 10 9 5 Removing All...

Page 207: ...low 100 ml min Message Stop circulation OK If the patient has to be reconnected touch the OK button Message Has the patient been reconnected Circulation Dialysis Continue Reconnect the patient Touch the Continue button Check the blood flow 10 11 Setting the Level in the Venous Bubble Catcher The venous bubble catcher must be correctly inserted into the level detector Mind the locator for the venou...

Page 208: ...hed in Preparation mode During a Double Needle treatment Single Needle Click Clack may be started or aborted at any time When reinfusion is started Single Needle Click Clack will be switched off An ONLINE HDF HF treatment currently in progress will be aborted and treatment will be continued with HD An ONLINE bolus can be administered at any time Reinfusion may be performed using the ONLINE option ...

Page 209: ...are 5008 OP 5 09 06 10 33 Message Connect the arterial and the venous patient line to the respective vascular access Double Needle Start Abort Connect the arterial and the venous patient line to the respective vascular access Touch the Start button ...

Page 210: ...Chapter 10 Other Functions 10 34 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 211: ...extended concentrate rack Weight Approx 125 kg without options 11 1 2 Type Label System Identification The type label shown is a sample only The decisive criterion is the data specified on the type label of the system 1 Type identification serial number 2 Power requirements 3 Protection against ingress of liquids drip proof 4 Caution consult accompanying documents 5 Equipment code EC Equipment Cod...

Page 212: ...akage currents According to EN 60601 1 11 1 4 Electrical Supply Line voltage 100 to 240 V AC 10 47 to 63 Hz The decisive criterion is the line voltage and the operating current specified on the type label of the system Connection to power supply 16 A regulation according to VDE 0100 part 710 Operating current dialysis Approx 6 A at 230 V at a water inlet temperature of 17 C Dialysate temperature 3...

Page 213: ...he 5008 hemodialysis system is intended for use in the electromagnetic environment specified below The customer or the user of the 5008 hemodialysis system should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be...

Page 214: ... m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and p...

Page 215: ...ily 95 The 5008 hemodialysis system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the 5008 hemodialysis system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the 5008 hemodialysis system as recommended below a...

Page 216: ...bility for the patient s safety rests with the operator of the machine Audible alarm suppression Mute alarm time maximum 2 minutes adjustable in the Operator setup Caution Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards e g IEC 60950 for data processing equipment Furthermore all configurations shall comply with the requirements fo...

Page 217: ...vel detected in the level detector Automatic raising of the fluid level during the rinse phase Reinfusion Reinfusion volume adjustable in the Operator setup Return to dialysis still possible Dialysis Bicarbonate dialysis ISO UF sequential therapy Ultrafiltration without dialysate flow Bergström method Single Needle Click Clack With blood pump arterial and venous occlusion clamp Pressure pressure c...

Page 218: ...ing of the water supply area 11 1 11 Dialysate Circuit and Safety Systems Blood leak detector Response threshold 0 5 ml blood loss per minute into the dialysate at a hematocrit of 0 25 flow rate 100 ml min to 1000 ml min Transmembrane pressure Display range 100 to 400 mmHg Resolution 5 mmHg Definition Ultrafiltration Selectable UF rate 0 ml h to 4000 ml h in increments of 10 ml Maximum rate intern...

Page 219: ... ml h Degassing Method Negative pressure Dialysate concentration conductivity Display range 12 8 to 15 7 mS cm Resolution 0 1 mS cm Accuracy 0 1 mS cm Method Temperature compensated electronic conductivity meter with adjustable alarm limits Concentrates Entering concentration types Adjustment range 125 to 151 mmol l depending on the concentrate used 10 of the base value Bicarbonate readjustment ra...

Page 220: ...ater inlet rate is not sufficient for achieving the maximum dialysate flow of 1000 ml min the admissible adjustment range will be delimited accordingly Rinse temperature Rinsing Desired temperature 37 C Resolution 0 5 C Measuring accuracy 0 2 C Hot rinse Desired temperature 85 C Resolution 0 5 C Measuring accuracy 2 0 C Disinfection temperature Cold disinfection Desired temperature 37 C Resolution...

Page 221: ...ers fully occluding pressure limited to 2 bar with 8 x 2 1 pump line segment when using the prescribed tubing systems Venous pressure measurement Display range 100 to 500 mmHg Resolution 5 mmHg Accuracy 7 mmHg typical OD senses light Alarm window width 100 to 500 mmHg OD senses dark Alarm window width 40 to 200 mmHg Default value adjustable in the Operator setup Factory setting 120 mmHg adjustable...

Page 222: ... minutes up to 2 hours Resolution 1 min Bolus administration 1 0 to 20 0 ml Resolution 0 1 ml 30 ml Fresenius heparin syringe Single Needle Click Clack Stroke volume depending on the blood lines used Cycle monitoring Arterial phase 50 ml Venous phase 15 s Width of SN pressure window venous pressure 80 to 480 mmHg Maximum SN pressure 480 mmHg Minimum SN pressure 20 mmHg Audible alarm Setting range ...

Page 223: ...luding pressure limited to 1 3 bar Auto sub Automatic control of the substitution rate considering the following factors Procedure pre postdilution Dialyzer class filter capacity Effective blood flow Hematocrit Hct Total protein TP UF rate If one of the above mentioned factors is altered the substitution rate will be adapted automatically 11 1 16 Single Needle Option Stop alarm Blood pump Single N...

Page 224: ... blood flow is 100 ml min Temperature measurement Accuracy of the fistula temperatures if correct ambient temperature is indicated 0 5 C Error in fistula temperatures per C error of the set ambient temperature 0 08 C at a blood flow of 100 ml min 0 03 C at a blood flow of 300 ml min Body temperature change accuracy 0 2 C Recirculation measurement Accuracy of recirculation measurement for 2 5 C ven...

Page 225: ...urement is valid only for plasma protein concentrations ranging between 60 and 85 g l 11 1 20 Network Caution The responsible organization of the network is responsible for protecting the system from excessive network load e g by accumulation of broadcast messages or port scans If necessary the connection to the network must be established via a router or a firewall for example The system configur...

Page 226: ...t the system to the electrical power source Actuate the power switch to turn the system on Leave the system on for 10 hours If the system is not used repeat this procedure every six months 11 3 Transportation O Inside buildings Release the brake The hemodialysis system can be swiveled turned or pushed in any direction To get over uneven surfaces e g elevator entry To avoid damage or prevent the ma...

Page 227: ...stem is taken back in accordance with directive 2002 96 EG WEEE Please also observe the applicable local legal regulations The system and the consumables are generally considered to be contaminated and must therefore be sufficiently disinfected by the responsible organization as specified by the manufacturer The respective regulations for the disposal of electronic scrap should be followed for the...

Page 228: ...rylonitrite butadiene styrene 20 glass fiber ABS Acrylonitrite butadiene styrene PA 6 6 Polyamide PC ABS Polycarbonate acrylonitrite butadiene styrene POM Polyoxymethylene EPDM PP Ethylene propylene terpolymer polypropylene PC Polycarbonate PU foam Polyurethane foam PS polystyrene Abbreviation Material Abbreviation Material Glass Glass Graphite Graphite Ceramics Ceramics V4A Special steel VA Speci...

Page 229: ...moplast Transformers Potting compound PU Polyester polyurethane Copper UP resin Iron cores Microswitches Polyacetal Glassfiber enforced polyamide Silicone Silver gold Brass Copper beryllium Cables Copper PVC Teflon Electronics P C B base material Epoxy fiberglass Ferrite cores Lithium batteries Lead acid batteries Abbreviation Material Adhesives Loctite 3321 UHU Plus Endfest Scotchweld DP 499 Insu...

Page 230: ...namel Screening lacquer copper conductive lacquer PUR structural lacquer Grease Unisilicone Abbreviation Material Abbreviation Material PVC Medical plasticized PVC PC Polycarbonate PVC Medical unplasticized polyvinyl chloride ABS Acrylonitrite butadiene styrene PA Polyamide PE Polyethylene Abbreviation Material PA Polyamide PE Polyethylene ...

Page 231: ...Chapter 11 System Description Fresenius Medical Care 5008 OP 5 09 06 11 21 ...

Page 232: ...terial occlusion clamp 2 Heparin pump 3 Arterial pressure measurement unit 4 Blood pump 5 Dialyzer 6 Venous pressure port 6a External hydrophobic filter 6b Venous pressure sensor 6c Valve 6d Orifice 6e Compressor 7 Level detector 8 Optical detector 9 Air bubble detector ABD 10 Venous occlusion clamp P P 2 1 3 5 6b 4 10 6d 9 7 6e 6c 8 6 6a ...

Page 233: ...ich prevents infusion of air The blood then flows from the air bubble detector via the venous occlusion clamp back to the patient Single Needle Click Clack The blood is transported through the extracorporeal blood circuit in a recurrent cycle The cycle consists of the arterial and the venous phases During the arterial phase the arterial occlusion clamp is open and the venous occlusion clamp is clo...

Page 234: ...ifice 2f Compressor 2g Valve SN 2 2h Internal compliance chamber 3 Single Needle pump ONLINEplus 4 Filter 1 5 Filter 2 6 Substituate valve 7 Substituate port 8 Rinse valve 1 9 Rinse port 10 Rinse valve 2 11 Substituate pump 12 SafeLine Connector to 13 Predilution or to 14 Postdilution 13 Connector predilution 14 Connector postdilution BTM option 15 Arterial measuring head 16 Venous measuring head ...

Page 235: ... the substituate is derived from the dialysate by means of two filter stages and a substituate pump and is supplied to the extracorporeal blood circuit predilution or postdilution BTM option The BTM arterial and venous measuring heads are designed to measure the temperature of the arterial and venous blood temperature at this position BVM option The BVM measuring head is designed to measure the re...

Page 236: ...ed before passing to the mixing system where it is mixed with the appropriate concentrates to produce dialysate In the balancing chamber the volumes to and from the dialyzer are volumetrically balanced The fresh dialysate then enters the dialyzer having passed through the DIASAFE plus and the dialyzer valve From dialyzer valve Conductivity temperature DIASAFEplus Retentate valve Bypass valve Blood...

Page 237: ...ms are in progress disinfectant is supplied via the mixing system and the hydraulics to clean and disinfect the unit 11 5 4 Description bibag When using the bibag a bag containing sodium bicarbonate powder NaHCO3 is used instead of a canister containing a liquid bicarbonate solution The powder is prepared in the hemodialysis system to produce ready to use bicarbonate For recommended values for the...

Page 238: ...f only 12 minutes are left until completion of the UF time If an OCM measurement is aborted e g by changing one of the dialysis parameters the measurement will be repeated at the next possible occasion Conductivity limits during a measurement To prevent a conductivity alarm the CD window will automatically and temporarily be spread while a measurement is in progress Changing the concentrate settin...

Page 239: ...sition of the fresh dialysate selected by the operator This applies to all electrolytes contained in the dialysate and especially the bicarbonate content of the fluid The amount of bicarbonate to be considered is determined by Restrictions An HF treatment may not be performed with a dialyzer with one filtrate connector HF filter without dialysate couplings 11 5 7 SN Description Option During SN di...

Page 240: ... 300 mmHg An additional monitoring unit ensures immediate deflation of the pressure if the pressure in the blood pressure cuff exceeds 320 mmHg Fields of application The BPM can be used to make the following blood pressure measurements Single measurement Interval long term interval measurement Quick short term interval measurement All values of the blood pressure measurements of one treatment are ...

Page 241: ...M module is designed for controlling the patient s body temperature according to the concept of physiological dialysis The importance of the blood temperature for cardiovascular stability has already been demonstrated by several studies Low dialysate temperatures proved to be favorable to circulation stability while higher temperatures resulted in an increase in the patient s core temperature and ...

Page 242: ...blood volume changes due to ultrafiltration or following fluid As a result the mass proportion and the protein concentration and thus the density of the examined blood will change Density changes of a medium may be determined by measuring the acoustic velocity Based on these criteria the BVM measures the density of the blood and the resulting parameters RBV Hct and Hb The blood volume is measured ...

Page 243: ...ed during a treatment with a constant UF rate or with a UF profile representing a permanent risk of a blood pressure drop due to insufficient refilling this treatment mode is characterized by continuous monitoring of the RBV Each event and each measure having an effect on the blood volume will be detected As a countermeasure the BVM rate may be reduced immediately in case of unfavorable changes of...

Page 244: ...rterial blood line 3 Arterial injection site collection site 4 Arterial pressure dome 5 Line guide 6 Pump segment 7 Dialyzer connector arterial blood line 8 Dialyzer 9 Dialyzer connector venous blood line 10 Venous injection site collection site 11 Connection venous pressure line 12 Venous pressure line 8 4 11 2 1 9 10 16 21 23 22 19 7 6 5 15 12 24 25 3 13 14 26 20 17 18 ...

Page 245: ...blood line 15 Venous patient connection 16 Heparin line 17 Heparin syringe 18 Connector predilution 19 Connector postdilution 20 Substituate connector SafeLine 21 SafeLine 22 SafeLine line guide 23 SafeLine pump segment 24 Connector pre postdilution SafeLine 25 Recirculating adapter SafeLine 26 Rinse connector ...

Page 246: ...erial pressure dome 5 Line guide 6 Pump segment 7 Dialyzer connector arterial blood line 8 Dialyzer 9 Dialyzer connector venous blood line 10 Venous injection site collection site 11 Connection venous pressure line 12 Venous pressure line 13 Venous bubble catcher 14 Venous blood line 15 Venous patient connection 16 Heparin line 17 Heparin syringe 18 Rinse solution bag 4 8 7 6 2 1 5 9 12 18 13 14 1...

Page 247: ...Chapter 11 System Description Fresenius Medical Care 5008 OP 5 09 06 11 37 19 Prime collection bag ...

Page 248: ... site collection site 4 Arterial pressure dome 5 Line guide 6 Pump segment 7 Dialyzer connector arterial blood line 8 Dialyzer 9 Dialyzer connector venous blood line 10 Venous injection site collection site 11 Connection venous pressure line 12 Venous pressure line 13 Venous bubble catcher 14 Venous blood line 4 6 11 3 1 5 9 12 18 13 14 16 17 21 23 22 7 20 15 8 28 31 27 32 2 10 24 25 19 29 30 26 ...

Page 249: ...ution 19 Connector postdilution 20 Substituate connector SafeLine 21 SafeLine 22 SafeLine line guide 23 SafeLine pump segment 24 Connector pre postdilution SafeLine 25 Recirculating adapter SafeLine 26 Rinse connector 27 Arterial blood line Single Needle part 28 SN line guide 29 SN pump segment 30 SN chamber 31 SN pressure line 32 Connector SN pressure line ...

Page 250: ...ion site collection site 4 Arterial pressure dome 5 Line guide 6 Pump segment 7 Dialyzer connector arterial blood line 8 Dialyzer 9 Dialyzer connector venous blood line 10 Venous injection site collection site 11 Connection venous pressure line 12 Venous pressure line 13 Venous bubble catcher 14 Venous blood line 15 Venous patient connection 4 7 6 11 2 1 5 9 12 18 15 16 17 14 13 19 21 22 24 20 25 ...

Page 251: ...Care 5008 OP 5 09 06 11 41 16 Heparin line 17 Heparin syringe 18 Rinse solution bag 19 Prime collection bag 20 Arterial blood line Single Needle part 21 SN line guide 22 SN pump segment 23 SN chamber 24 SN pressure line 25 Connector SN pressure line ...

Page 252: ...tential equalization to the rear of the machine if this is required by the legal regulations at the place of installation e g according to VDE 0100 107 in rooms of application group 2 If additional equipment which is not included in the accessories is connected to the dialysis system there is a danger that the permissible leakage currents will be exceeded Caution The system may only be used in acc...

Page 253: ...but with an application current exceeding the specified leakage currents e g on electro stimulators must not be used This also applies to defibrillators which have no applied part type CF If all requirements have been fulfilled these devices may be operated on the patient or within the reachable area of the patient provided they are like the dialysis system integrated into the potential equalizati...

Page 254: ...dialysis system The quality of the water should comply with the local regulations e g European Pharmacopoeia 4th Edition ISO 13959 2002 Specifications The ranges of the water inlet pressure the supply pressure of the dialysate concentrate the temperature and the flow rates which are required for operating the hemodialysis system are listed in the chapter Specifications Installation The national re...

Page 255: ...entrate is an ideal nutrient medium for microorganisms The use of sterile or microorganism poor concentrates is recommended Online dry concentrates bibag assist in the preparation of dialysate with high microbiological quality The use of concentrate residues from open containers and the preparation of bicarbonate concentrate in the dialysis center are not recommended Central delivery systems for c...

Page 256: ...ption 11 46 Fresenius Medical Care 5008 OP 5 09 06 11 7 5 Performing the Initial Start Up For initial start up it is imperative to follow the start up report A current start up report is supplied with each hemodialysis system ...

Page 257: ... Safety Checks must be entered in the Medical Device Register The following applies to the Technical Measurement Checks After successful completion of the technical measurement checks the respective parts of the hemodialysis system must be identified with a sign label This label must in a unique and traceable manner specify the year of the next Technical Measurement Check and the authority or pers...

Page 258: ... proper function T 1 6 Rotor position blood pump checked Rotor cleaned Only with ONLINEplus Rotor position substituate pump checked Rotor cleaned Only with Single Needle Rotor position Single Needle pump checked Rotor cleaned T 1 10 Filter F06 replaced T 1 18 Only with ONLINEplus O rings at substituate port and rinse port replaced T 2 General checks 2 1 Power failure alarm checked Permanent tone a...

Page 259: ...ed the following values within 3 minutes Arterial pressure display maximum change in pressure 5 mmHg Pressure display of reference measuring instrument maximum pressure drop 0 1 bar T 6 Options 6 1 BPM 6 1 4 TMC Leakage test performed Pressure leakage rate 6 mmHg min ________ T 6 1 5 TMC Safety valve tested System emptied at 320 mmHg 10 mmHg ________ T 6 1 6 TMC Blood pressure measurement performe...

Page 260: ... Device leakage current mains polarity 2 _______ μA with line voltage _______ V scaled to nominal voltage maximum 500 μA see Additional requirements _____ μA 8 Final inspection and testing 8 1 T1 test performed with all options T 8 2 Disinfection performed T Test equipment used Temperature conductivity pressure type serial number ____________________________________________________________________...

Page 261: ...hapter 11 System Description Fresenius Medical Care 5008 OP 5 09 06 11 51 The system has been released for its intended use Attach test badge T Yes T No Next inspection date Comments Date Signature Stamp ...

Page 262: ... venous blood port on the dialyzer Dialysate The exchange fluid used in dialysis Dialysate pressure The pressure present in a defined section of the system carrying the dialysate e g at the dialyzer outlet Pressure line connection Connector for the pressure line e g Luer lock Pressure line Line connecting the tubing system to the pressure monitoring unit Compliance chamber Receptacle for leveling ...

Page 263: ...rane pressure on blood side dialysate pressure Venous return pressure Pressure in the extracorporeal circuit before the venous cannula e g in the venous bubble catcher Water alarms Group of alarms which do not cause the blood systems to be turned off conductivity bypass operation temperature bypass operation flow 11 10 Abbreviations AC Alternating current BC Balancing chamber BIC Bicarbonate BP Bl...

Page 264: ...ssure TSC Technical Safety Checks TSC UF Ultrafiltration 11 11 Symbols Caution consult accompanying documents General danger Protection against ingress of liquids Drip proof IPX1 Degree of protection against electric shock Type B Degree of protection against electric shock Defibrillator protected applied part of type CF Alternating current Protective conductor terminal Ground terminal Equipotentia...

Page 265: ...rature Risk of tilting when inclined by more than 5 ON OFF On Off Blood pump Mute Transmitter Identification of electric and electronic devices I O Refer to the Operating Instructions Do not re use Use by Batch code Date of manufacture Quantity Catalogue number Temperature limitation Pump segment diameter 2 LOT REF 30 C 5 C ...

Page 266: ...System Description 11 56 Fresenius Medical Care 5008 OP 5 09 06 Sterile Sterilised using ethylene oxide Sterile Sterilised using irradiation Sterile Sterilised using steam or dry heat STERILE EO STERILE R STERILE ...

Page 267: ...system Caution The system has been approved for use with the consumables and accessories listed in the Operating Instructions Should the responsible organization wish to use other consumables and accessories than those listed in the Operating Instructions the responsibility to ensure the correct function of the system lies exclusively with the responsible organization The applicable legal regulati...

Page 268: ...sis concentrate 1 34 SK F 35 fold for mixing with basic sodium hydrogen carbonate concentrate 8 4 O Bicarbonate dry concentrate for bibag 12 6 Dialysate Filter DIASAFE plus Product Part number Information 30 ml heparin syringe 503 032 1 Luer lock connector latex free plug Product Part number Information bibag 650 g NaHCO3 506 078 1 16 bags per box bibag 900 g NaHCO3 506 080 1 12 bags per box Produ...

Page 269: ...description 0 5 1 hour 1 0 15 minutes D F NL I 508 569 1 GB E P SLO 508 573 1 RUS PL RO BG 508 579 1 S DK CZ SK 508 577 1 GR H HR TK 508 578 1 50 ml beaker 603 062 1 20 ml dosing pump 603 063 1 Product Part number Information Fresenius Medical Care Diasteril 508 564 1 6 liters Active substance base hydroxyacetic acid Active substance concentration approx 0 8 diluted Fresenius Citrosteril 508 535 1...

Page 270: ...08 570 1 E P I H HR GR 508 571 1 RUS SK RO PL SLO GB 508 572 1 Product Part number Information Fresenius Sporotal 100 508 542 1 5 kg container Active substance base sodium hypochlorite Active substance concentration approx 0 1 diluted Product Part number Information pH test strips 628 816 3 Indicator for Diasteril Potassium iodide starch paper 508 521 3 6 x 100 strips Indicator for Sporotal 100 In...

Page 271: ...Chapter 13 Certificates Fresenius Medical Care 5008 OP 5 09 06 13 1 13 Certificates 13 1 EC Certificate ...

Page 272: ...Chapter 13 Certificates 13 2 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 273: ...Chapter 13 Certificates Fresenius Medical Care 5008 OP 5 09 06 13 3 ...

Page 274: ...Chapter 13 Certificates 13 4 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 275: ...thers by Professor Dr med Jürgen Bommer from the Ludolf Krehl Klinik in Heidelberg Filtration of dialysate using an ON LINE dialysate filter dated June 5 1990 among others by Francise Dumler MD Division of Nephrology Hypertension Henry Ford Hospital 2799 West Grand Blvd Detroit MI 48202 USA as well as Fresenius brochures on DIASAFE and polysulfone high flux with literature Hemodiafiltration with O...

Page 276: ...Chapter 14 Appendix 14 2 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 277: ...Fold Out Sheet 15 OCM Fresenius Medical Care 5008 OP 5 09 06 ...

Page 278: ...OCM SCREEN OCM diagram ...

Page 279: ...curacy of V is the responsibility of the attending physician If no valid value for V is available neither entered directly nor calculated from the patient data Kt instead of Kt V will be calculated and displayed Interval Time between two measuring cycles Hct Percentage of the volume of the red blood cells in the total blood Clearance The clearance K in ml min is the average effective urea clearanc...

Page 280: ... 2 Menu Overview 1 Goal Kt V Displays the Goal Kt V Touch the Goal Kt V field or entering the Goal Kt V 2 Interval Displays the measurement interval Touch the Interval field for entering the measurement interval 3 Hct Displays the hematocrit Touch the Hct field for entering the hematocrit Note The accuracy of the plasma Na value depends on the recirculation 2 8 Clearance Interval 1 Goal Kt V 4 V u...

Page 281: ...V Dialysis dose prescribed by the physician Interval Time between two measuring cycles Hct For the calculation of K and Plasma Na V urea Volume of urea distribution of the patient to be entered in liters Weight For the calculation of V urea Height For the calculation of V urea Age For the calculation of V urea Sex For the calculation of V urea Note We recommend entering V urea If V urea is not kno...

Page 282: ... if all parameters are sufficiently stable Stability criteria Stable conductivity Not change of the blood flow by more than 10 ml min Not change of the substituate flow by more than 10 ml min Blood flow 80 ml min Dialysate flow 270 ml min 15 5 Starting the OCM In the OCM menu Touch the OCM I O button or automatic start depending on the setting in the Operator setup The measurement starts approxima...

Page 283: ...09 06 15 5 15 7 Alarm Processing Message Kt V warning A warning will be displayed if the OCM detects after approx 90 minutes of treatment that the Kt V goal is expected to be more than 15 below the Kt V goal which has been entered This warning can be deactivated in the Operator setup ...

Page 284: ...Chapter 15 Option OCM Online Clearance Monitoring 15 6 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 285: ...Fold Out Sheet 16 ONLINEplus Fresenius Medical Care 5008 OP 5 09 06 ...

Page 286: ...ONLINE SCREEN ...

Page 287: ...Chapter 16 ONLINEplus Fresenius Medical Care 5008 OP 5 09 06 16 1 16 ONLINEplus ...

Page 288: ...Displays the substitution goal 3b Sub rate Displays the substitution rate 3c Sub volume Displays the substitution volume 3d Sub pump I O Button for starting stopping the substituate pump 4a Bolus Displays the bolus volume 4b Bolus rate Displays the bolus rate 4c Cum Bolus Displays the cumulated bolus volume 1 7 HCT Treatment mode 2 Auto sub I O 3 Substitution 6 TP 5 Dialyzer 3d 3c 3b 3a 4d 4c 4b 4...

Page 289: ...pe 6 TP Displays the total protein 7 HCT Displays the hematocrit 8 ONLINE ONLINE menu button 16 2 Preparation Treatment Reinfusion The treatment using the ONLINEplus module is described in the following chapters Preparation using ONLINEplus see chapter 5 1 page 5 1 Preparation using ONLINEplus see chapter 6 1 page 6 1 Reinfusion using ONLINEplus see chapter 7 1 page 7 1 ...

Page 290: ...Chapter 16 ONLINEplus 16 4 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 291: ...Fold Out Sheet 17 Option SN Fresenius Medical Care 5008 OP 5 09 06 ...

Page 292: ...SINGLE NEEDLE SCREEN ...

Page 293: ...Chapter 17 Option SN Single Needle Fresenius Medical Care 5008 OP 5 09 06 17 1 17 Option SN Single Needle ...

Page 294: ... the Single Needle pump rate is defined automatically 3 Ratio Displays the ratio of the blood pump rate to the Single Needle pump rate 4 SN rate Displays the SN rate Rocker switch for increasing reducing the Single Needle flow 5 Stroke vol Displays the effective blood flow 6 Effective blood flow Displays the Single Needle stroke volume 7 SINGLE NEEDLE SINGLE NEEDLE menu button 1 Single Needle I O ...

Page 295: ...plus see chapter 5 3 page 5 31 Single Needle option preparation with rinse solution bag see chapter 5 4 page 5 47 Single Needle option treatment using ONLINEplus see chapter 6 3 page 6 9 Single Needle Option treatment prepared with rinse solution bag see chapter 6 4 page 6 17 Single Needle option reinfusion using ONLINEplus see chapter 7 3 page 7 9 Single Needle option reinfusion with rinse soluti...

Page 296: ...Chapter 17 Option SN Single Needle 17 4 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 297: ...Fold Out Sheet 18 Option BPM Fresenius Medical Care 5008 OP 5 09 06 ...

Page 298: ...BPM graphic SYS DIA PULSE BPM SCREEN BPM SCREEN Interval BPM SCREEN Quick BPM MAP graphic MAP PULSE BPM history Applying the blood pressure cuff a b ...

Page 299: ...infants The pressure tubing must neither be kinked nor squeezed While using the BPM make sure that the patient s blood circulation is not affected by the continuous presence of blood pressure cuff over a prolonged treatment time especially when repeatedly using the automatic short term mode Product Part number Information Blood pressure cuff Velcro M35 972 1 Adults small arm arm circumference 17 c...

Page 300: ...splayed in block representation according to the window size Touch the SYS DIA or MAP field for setting the alarm limits 2 PULSE The actual value is displayed as a numerical value and as a bar The alarm window is displayed in block representation according to the window size Touch the PULSE field for setting the alarm limits Product Part number Information Pressure tubing M35 618 1 Non conductive ...

Page 301: ...rogress green Interval long term interval selected measurement pause yellow 7 BPM BPM menu button 18 4 Applying the Blood Pressure Cuff Place the blood pressure cuff tightly and correctly around the selected limb e g the upper arm Observe the illustrations shown on the fold up page The blood pressure cuff must be correctly aligned and must have a good contact to the skin The marking must be positi...

Page 302: ...is 3 minutes A measurement is repeated no more than 3 times Single measurement Touch the Blood pressure button Blood pressure display green Interval long term interval measurement In the BPM menu Touch the Interval field Select the desired interval Touch the OK button to confirm the value entered Visually check the confirmed value Touch the Blood pressure button Blood pressure display green The Bl...

Page 303: ...ettings in the Operator setup the following items can be displayed in the respective treatment menu BPM graphic contains SYS DIA and PULSE BPM MAP graphic contains MAP and PULSE BPM history for up to 60 measurements contains SYS DIA MAP and PULSE Use the V or W button to scroll through the BPM history if required Caution If it is not possible to abort the blood pressure measurement with the Blood ...

Page 304: ...Chapter 18 Option BPM Blood Pressure Monitoring 18 6 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 305: ...Chapter 19 Option CBPM Fresenius Medical Care 5008 OP 5 09 06 19 1 19 Option CBPM not yet available ...

Page 306: ...Chapter 19 Option CBPM 19 2 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 307: ...Fold Out Sheet 20 BTM Option Fresenius Medical Care 5008 OP 5 09 06 ...

Page 308: ...Inserting the tubing system into the measuring heads BTM events a b BTM SCREEN BTM T control graphic BTM rec graphic ...

Page 309: ...20 1 20 Option BTM Blood Temperature Monitor 20 1 To Be Observed Before Using the BTM Option Note The ambient temperature must match the ambient temperature set in the Operator setup BTM submenu Do not cover the blood lines as this would result in a deterioration of the measuring accuracy ...

Page 310: ...p control I O Button for starting stopping the body temperature control 3 Temperature change rate Entry of the body temperature change rate 4 Recirculation Display of the complete recirculation fraction 5 Temperature change Display of the body temperature change since beginning of the treatment 6 BTM BTM menu button 3 Temperature change rate 4 Recirculation 5 Temperature change 1 Recirculation I O...

Page 311: ...ulation I O indicator green Automatic depending on the settings in the Operator setup After completion of the recirculation measurement the result is displayed in the BTM menu under Recirculation O Aborting Touch the Recirculation I O button Recirculation I O indicator grey BTM inactive BTM measuring fistula temperature BTM recirculation measurement active BTM body temperature control active Cauti...

Page 312: ...settings in the Operator setup After completion of the recirculation measurement the result is displayed in the BTM menu under Recirculation The temperature control then starts automatically O Aborting Touch the Temp control I O button Temp control I O indicator grey 20 6 Displaying Graphics and BTM Events Depending on the settings in the Operator setup the following items can be displayed in the ...

Page 313: ...Fold Out Sheet 21 BVM Option Fresenius Medical Care 5008 OP 5 09 06 ...

Page 314: ...BVM SCREEN Inserting the tubing system into the measuring head BVM Rel blood volume graphic BVM BPM BVM events Inserting the tubing system without cuvette ...

Page 315: ...measurement Do not open the door of the BVM measuring head during the treatment If using the ONLINEplus option the SafeLine must not be kinked The BVM measuring head must not be exposed to intensive direct sunlight Caution The following must be observed when inserting the tubing system without cuvette on hemodialysis system with BVM option Do not insert the tubing without cuvette into the measurin...

Page 316: ...pping the special mode supporting the determination of the critical RBV which can be set individually for every patient Function while the BVM is measuring At the end of the treatment the lowest measured RBV min RBV will be transferred to the PatientCard as the new crit RBV If during the treatment one or several blood pressure measurement s occurred with a lower systolically MAP or diastolically b...

Page 317: ...isplay is available in the BVM menu but also in the UF MENU and on the PREPARATION SCREEN If the BVM field is touched the system switches to the BVM menu In the BVM display the following symbols may appear 7 RBV relative blood volume 7a Crit RBV Displays the critical relative blood volume of the respective treatment percentage Must be set prior to each treatment or is transferred automatically e g...

Page 318: ...on requirements The BVM cuvette must be filled with a rinse solution The temperature of the rinse solution exceeds 18 C Cuvette calibration for increasing the measuring accuracy is performed automatically After successful calibration the BVM symbol Cuvette calibrated will be displayed 21 5 Measuring the RBV Relative Blood Volume Hemoglobin and Hematocrit When detecting blood inside the cuvette the...

Page 319: ...ill be set If a PatientCard is used this new crit RBV will also be used for the next treatment Touch the Continue button if the patient s condition is not good The control continues in the usual manner Message Message BVM Achieving UF goal is uncertain Continue UF control or set a minimum BVM rate of XXX ml h Control Continue Minimum rate Set This message is displayed only during the first half of...

Page 320: ...isplayed only once during the second half of the volume to be removed Until the end of the treatment at least the minimum BVM rate will be used lower limitation of the BVM rate even if the RBV continues to decrease If the patient recovers treatment will be performed with a higher BVM rate according to the RBV The minimum UF goal prescribed will imperatively be respected After the UF control parame...

Page 321: ...aution Before being applied the treatment parameters which the 5008 hemodialysis system receives via the network or the patient card must be checked by the operator for plausibility and compliance with the medical prescription The data transfer of alarm states via the network must not be used as an external alarm alert staff call Note For reasons of data protection the operator is responsible for ...

Page 322: ...e and further pages which can be selected from a table of contents tabs are transferred to the DataXchange Panel O Closing the DataXchange Panel To close the DataXchange Panel touch the Patient ID button in the header or pull out the patient card outside of treatment or select other screens e g the UF SCREEN O DataXchange Panel data transfer If the indicator in the Patient ID display is flashing n...

Page 323: ...on detects kinked blood lines between the blood pump and the dialyzer or clots beginning to develop in the dialyzer and emits a warning O Description The BLK checks the extracorporeal tubing system between the blood pump and the venous bubble catcher for changes in the flow resistance The BLK principle is based on monitoring the signals at the venous pressure sensor The blood pump generates period...

Page 324: ...hreshold values for triggering a BLK warning will be adjusted accordingly in order to avoid following messages 23 3 WET Caution Preventing contamination Use tubing systems with hydrophobic filters at the pressure lines to prevent cross contamination Connect the hydrophobic filters so that an ingress or loss of air is not possible and that any wetting by fluid is reliably avoided also in case of pr...

Page 325: ... detector sensing blood In the Single Needle or in the Single Needle Click Clack treatment mode the WET is not activated O Alarm processing Message Please check if the hydrophobic filter on the venous pressure transducer is wet Device adaptation Accept Problem corrected Confirm Touch the Confirm button after you have detected and eliminated an obvious problem in the tubing system The threshold val...

Page 326: ...Chapter 23 Options BLK WET 23 4 Fresenius Medical Care 5008 OP 5 09 06 ...

Page 327: ... modified appropriately for connection with the smartbag Bicarbonate continues to be supplied via a bibag a bicarbonate container or a central bicarbonate supply 24 2 Connecting the smartbag In Preparation mode From the Dialysate menu select Concentrate 1 Install the smartbag in the holder 2 Open the concentrate flap 3 Remove the protective cap from the smartbag Tightly screw the concentrate conne...

Page 328: ...9 06 24 3 Removing the smartbag After the end of the treatment 1 Close the clamp on the smartbag 2 Open the concentrate flap 3 Remove the concentrate connector red from the smartbag and connect it to the rinse chamber 4 Close the concentrate flap 5 Remove the smartbag ...

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