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Fresenius Medical Care multiFiltrate, Instructions For Use Manual

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Chapter 12:  Specifications

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015

12-5

12.5 Information on electromagnetic compatibility

12.5.1 Minimum distances between radiated interference source and the device

Medical electrical devices are subject to special precautionary 
measures with regard to electromagnetic compatibility (EMC).

Portable and mobile high-frequency RF communication equipment is a 
source of radiated electromagnetic interference that can affect medical 
electrical devices. This can lead to device malfunctions.

For this reason, a certain minimum distance must be kept between 
radiated interference sources in the vicinity of running medical electrical 
devices.

For further information on "Guidance and manufacturer's declaration on 
EMC", refer to the Service Manual.

Warning

 

Patient hazard due to device malfunction

 

Using accessories or lines other than those specified in the Instructions 
for Use can lead to increased emitted interference or reduced 
interference immunity of the device.

Check the suitability of accessories and lines which are not specified 
in the Instructions for Use.

Warning

 

Patient hazard due to possible device malfunction

 

A device malfunction can be caused by high-frequency electromagnetic 
waves (radiated interference source).

Observe the minimum required distances for radiated interference 
sources.

Summary of Contents for multiFiltrate

Page 1: ...multiFiltrate Instructions for Use Software version 5 3 Edition 15A 2015 Part no M56 963 1 ...

Page 2: ......

Page 3: ...fects 2 5 2 6 7 Contraindications 2 6 2 6 8 Interaction with other systems 2 7 2 6 9 Restrictions 2 7 2 6 10 Risks of regional anticoagulation 2 7 2 6 11 Target group 2 7 2 7 To be observed when working on the device 2 8 2 8 Expected service life 2 8 2 9 Duties of the responsible organisation 2 8 2 10 Operator responsibility 2 9 2 11 Disclaimer of liability 2 10 2 12 Warnings 2 10 2 12 1 Warnings ...

Page 4: ...l test 4 14 4 4 3 Selecting the anticoagulation method 4 15 4 4 4 Continuing the previous treatment 4 15 4 4 5 Selecting the treatment mode 4 16 4 5 CRRT treatments 4 17 4 5 1 Starting conditions 4 17 4 5 2 Inserting the cassette system or AV set 4 17 4 5 2 1 Inserting the cassette system 4 17 4 5 2 2 Inserting the arterial blood line system 4 18 4 5 2 3 Inserting the venous blood line system 4 18...

Page 5: ...ubing system entering treatment parameters 4 40 4 6 6 5 UF rinse 4 42 4 6 6 6 Recirculation waiting for patient 4 42 4 6 6 7 Connecting the patient 4 43 4 6 7 Treatment 4 44 4 6 7 1 Checking the post filter calcium concentration 4 44 4 6 7 2 Treatment main screen 4 45 4 6 7 3 Treatment menu 4 46 4 6 7 4 Treatment parameters 4 46 4 6 8 End of treatment 4 47 4 6 8 1 Terminating the treatment 4 47 4 ...

Page 6: ...ent 4 70 4 8 6 5 Filling plasma 4 71 4 8 6 6 Connecting the patient 4 72 4 8 7 Treatment 4 73 4 8 7 1 Treatment main screen 4 73 4 8 7 2 Treatment menu 4 73 4 8 7 3 Treatment parameters 4 74 4 8 7 4 Performing a bag change 4 74 4 8 8 End of treatment 4 76 4 8 8 1 Infusing remaining plasma 4 76 4 8 8 2 Terminating the treatment 4 77 4 8 8 3 Starting reinfusion 4 77 4 8 9 Disconnecting the patient a...

Page 7: ...1 4 10 7 2 Starting reinfusion 4 101 4 10 8 Disconnecting the patient and removing the tubing system 4 103 4 10 9 Treatment history 4 103 4 11 Treatment menu 4 104 4 11 1 Deselecting Ci Ca anticoagulation 4 104 4 11 2 Selecting Ci Ca anticoagulation 4 105 4 11 3 Substituate dialysate filtrate bag change 4 107 4 11 4 Ci Ca bag change 4 107 4 11 5 Syringe change 4 109 4 11 6 Pressure graphs 4 110 4 ...

Page 8: ...ate flow to BP rate 5 15 5 13 Overriding the blood leak detector 5 16 5 14 Power failure mains failure 5 18 5 15 Manual reinfusion 5 19 6 Cleaning disinfection 6 1 Surface cleaning surface disinfection 6 1 6 2 Disinfectants and cleaning agents 6 1 7 Functional description 7 1 Device functions 7 1 7 2 Description of treatments 7 2 7 2 1 Continuous renal replacement therapy CRRT Continuous renal rep...

Page 9: ...inges 8 4 8 1 7 Other disposables 8 5 8 2 Accessories 8 6 8 3 Additional equipment 8 6 9 Installation 9 1 Connection requirements 9 1 9 1 1 Environment 9 1 9 1 2 Power supply network 9 1 9 2 Installation initial start up requirements 9 2 9 3 Important information on initial start up 9 2 9 4 Electrical installation 9 3 10 Transport storage 10 1 Relocation 10 1 10 2 Transport 10 3 10 3 Storage 10 3 ...

Page 10: ...itions 12 9 12 7 Storage conditions 12 10 12 8 External connection options 12 10 12 9 Operating programs 12 11 12 10 Balancing dialysate circuit and safety systems 12 12 12 11 Extracorporeal blood circuit and safety systems 12 14 12 12 Materials used 12 16 13 Definitions 13 1 Terms 13 1 13 2 Abbreviations 13 3 13 3 Symbols 13 4 13 4 Consumables symbols 13 6 13 5 Certificates 13 7 14 Options 14 1 C...

Page 11: ...Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 xi 15 2 Instructions on the use of free software 15 2 ...

Page 12: ...xii Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 13: ...tion 2 3 C Calcium dose 7 23 13 1 Calcium flow 5 14 13 1 Calcium pump 12 16 13 1 Calcium rate 13 2 Certificates 13 7 Changes 2 2 Check 2 12 4 4 Ci Ca anticoagulation deselecting 4 104 Ci Ca anticoagulation selecting 4 105 Ci Ca bag change 4 107 Ci Ca drop counter 12 15 Ci Ca module 3 7 3 8 14 1 Citrate accumulation 7 27 Citrate dose 7 22 13 2 Citrate flow 5 15 13 2 Citrate pump 12 15 13 2 Citrate ...

Page 14: ...ntification label of the Ci Ca module 12 3 Identification label of the device 12 2 Illustrations 2 1 Importance of the instructions 2 1 Important information 2 1 Important information on initial start up 9 2 Initial start up 9 2 Initial start up report 9 2 Initial start up requirements 9 2 Insertion switch 13 2 Installation 9 1 Intended use 2 3 Interrupting the treatment 4 121 K Key sound 4 119 L ...

Page 15: ... 4 107 Surface cleaning surface disinfection 6 1 Symbols 8 1 13 4 Syringe change 4 109 System parameters 4 119 12 12 Systemic anticoagulation 2 4 2 6 7 16 Systemic calcium concentration 13 3 T Technical Safety Checks 11 1 Temperature 10 4 12 10 Terms 13 1 Time 4 120 Tip significance 2 2 TMP 12 14 Transport 10 1 Treatment 12 12 Treatment main screen 4 6 Treatment mode selecting 4 16 Treatment modes...

Page 16: ...Chapter 1 Index 1 4 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 17: ...anisation of the chapters To facilitate the use of documents from Fresenius Medical Care the organisation of the chapters has been standardised in all manuals There may therefore be chapters within this document without any content Chapters without content are identified Styles used in the document The following text styles may be used in the document Illustrations The illustrations used in the do...

Page 18: ...ndling of the device Changes Changes to the document will be released as new editions or supplements In general this manual is subject to change without notice Reproduction Reproduction even in part is only permitted with written approval 2 2 Significance of warnings 2 3 Significance of notes 2 4 Significance of tips Warning Advises the operator that failure to observe this information can result ...

Page 19: ...ter or an adsorber The blood can be continuously anticoagulated An air bubble detector prevents the infusion of air to the patient Any dangerous loss of blood is prevented by a blood leak detector and by monitoring of the return pressure The inflow pressure monitoring unit detects excessive suction at the cannula or at a catheter The device is classified as Class II b MDD equipment 2 6 Intended us...

Page 20: ...tients need an anticoagulant to prevent their blood from coagulating in the extracorporeal blood circuit This can be performed systemically i e also in the patient s body or regionally limited to the extracorporeal blood circuit Systemic anticoagulation The integrated heparin pump can be used for the continuous anticoagulation of the blood Regional anticoagulation with citrate The Ci Ca function i...

Page 21: ...ver it is already possible to change from the paediatric mode of the device to one of the treatment modes for adults when treating smaller patients According to the prescribed procedure the minimum dose of 600 ml h HF solution dialysate which can be set with CVVH or CVVHD in the adult s treatment modes corresponds to a minimum body surface of the patient of 0 52 m which matches approximately a bod...

Page 22: ...rate metabolism is suspected because of a restricted liver function citrate anticoagulation can still be started however under particularly intensive monitoring In this case the signs of systemic citrate accumulation must be observed closely This applies especially to a decrease in the systemic ionised calcium high calcium substitution requirements for stabilising the ionised calcium and to an inc...

Page 23: ... CVVHDF 2 6 10 Risks of regional anticoagulation If citrate anticoagulation is used in CRRT treatments attention must be paid to risks regarding the acid base status and the electrolyte concentrations Further information see chapter 7 3 2 on page 7 17 Interrupting the treatment Any interruption of the treatment by temporarily disconnecting the patient from the extracorporeal circuit may give rise ...

Page 24: ...e according to IEC 60601 1 will therefore be prolonged until the next prescribed Technical Safety Check 2 9 Duties of the responsible organisation Requirements The responsible organisaion must ensure that the following requirements are fulfilled Compliance with the national or local regulations concerning the installation operation use and maintenance of the device Compliance with the accident pre...

Page 25: ...ntered must be verified by the operator i e the operator must check that the values entered are correct If this check reveals a deviation between the required parameters and the parameters displayed on the device the setting must be corrected before activating the function The actual values displayed must be compared with the prescribed target values The device may only be operated under the opera...

Page 26: ...ble by obtaining relevant information from the manufacturer for example The applicable legal regulations must be complied with The manufacturer does not assume any responsibility or liability for personal injury or other damage and excludes any warranty for damage to the device resulting from the use of non approved or unsuitable consumables or accessories Warning Aseptic techniques Use aseptic te...

Page 27: ...d for contamination by service support If the device is contaminated all affected parts must be disinfected or replaced by service support Warning Before starting a treatment check the following All the connections of the tubing system are securely connected There are no apparent leaks in the tubing system either during or after filling priming If leaks are detected tighten the relevant connection...

Page 28: ...larly all of the tubing system connections and the venous access point must be checked for leaks at appropriate intervals during the treatment The tubing system watching out for air ingress or possible loose connections Particularly at the connections downstream of the air detector negative pressure can permit air to enter into the extracorporeal blood circuit This can be a problem for single need...

Page 29: ...nce characteristics Measures An ongoing therapy must be terminated The device must be taken out of service Inform the responsible organisation or service support without delay Warning Risk of injury if device tilts Risk of tilting when pushing the device or leaning against it If lateral force is exerted this may result in tilting or slipping of the device Observe the information on relocation and ...

Page 30: ...es specific regulations of the national authorities are in force Warning Danger to life due to electric shock If treatments are carried out using central venous catheters positioned in the atrium please observe the following points Connect the device multiFiltrate to the equipotential bonding of the installation Remove all other non medical electrical devices and medical electrical devices with a ...

Page 31: ...s are as follows 10 µA AC DC normal case error free 50 µA AC DC the first time an error occurs Please address any queries to the local service support organisation 2 12 5 Warnings relating to consumables and accessories Warning Consumables must be discarded after the treatment in compliance with the regulations for the disposal of potentially contaminated materials ...

Page 32: ...acturer Fresenius Medical Care AG Co KGaA 61346 Bad Homburg Germany Phone 49 6172 609 0 www fmc ag com International service support Fresenius Medical Care Deutschland GmbH Service Support International Hafenstrasse 9 97424 Schweinfurt Germany Phone 49 9721 678 333 hotline Fax 49 9721 678 130 Local service support ...

Page 33: ...esenius Medical Care multiFiltrate IFU EN UK 15A 2015 3 1 3 Design 3 1 Views of the device 3 1 1 Front view Legend 1 IV pole 2 Scale 1 3 Scale 2 4 Monitor 5 Extracorporeal blood circuit module 6 Scales 3 and 4 4 5 6 1 3 2 ...

Page 34: ...r 3 Design 3 2 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 3 1 2 Rear view Legend 1 Tube holders 2 Heparin pump 3 Identification label 4 Connector strip 5 Pocket for Instructions for Use 3 4 1 2 5 ...

Page 35: ...ate IFU EN UK 15A 2015 3 3 3 1 2 1 Connector strip Legend 1 Power switch 2 Line voltage selector 3 Power supply connection 4 Equipotential bonding 5 10 Base T Ethernet socket LAN option 6 RS 232 SUB D 9 pin 7 Alarm output 8 Loudspeaker 1 2 4 5 6 7 8 3 ...

Page 36: ... 2015 3 2 Controls and indicators 3 2 1 Monitor Legend 1 Screen 2 Tube holders 3 Rotary selector and OK key 4 ESC key 5 Mute key 6 STOP key 7 START RESET key 8 On Off key 9 Status indicator Green LED operation Yellow LED warning preparation Red LED alarm 1 8 3 4 5 6 7 9 2 ...

Page 37: ... 2015 3 5 3 2 2 Heparin pump Legend 1 The key moves the slide carriage up as long as the key is pressed 2 The key moves the slide carriage automatically down Pressing this key again will stop the slide carriage 3 Syringe holder 4 Slide carriage 5 Grip handle 1 2 3 5 4 ...

Page 38: ...der 8 Tube holder 9 Blood leak detector 10 Venous tube clamp and optical detector 11 Filtrate pump yellow dot 12 Warning label Protection against the effects of defibrillator discharge is only provided when using appropriate tubing systems see chapter 8 1 1 on page 8 2 13 Filtrate pressure port yellow 14 Air detector 15 Blood pump red dot 16 Pressure port before filter white 17 Arterial pressure p...

Page 39: ...Chapter 3 Design Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 3 7 3 2 4 multiFiltrate with Ci Ca module option Legend 1 Second IV pole with connector in the IV pole bearing 2 Ci Ca module 2 1 ...

Page 40: ...itrate drop counter 2 Citrate pump 3 Citrate insertion switch 4 Calcium drop counter 5 Calcium pump 6 Calcium insertion switch 3 2 4 2 Ci Ca module rear view Legend 1 Holder for IV pole 2 Securing lever with pressure roll 3 Voltage supply and signal connection to the multiFiltrate 4 Earthing contact 1 2 4 3 5 6 1 2 3 4 ...

Page 41: ...nt menu 3 The remaining prime and rinse volume or the treatment time 4 The current balance or balancing switched off 5 The current anticoagulant or anticoagulant switched off B Menu field 1 Pressure display 2 Notes white warnings yellow alarms red and pressure graphs 3 Parameter fields 4 Confirmation field 5 Screen identification number C Menu bar Shows the available menus The currently selected m...

Page 42: ...Chapter 3 Design 3 10 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 43: ...ent parameters must be entered as specified by the physician The device has to be operated according to the instructions on the screen Warning The operator must never simultaneously touch the patient and the contact surface of the Ethernet socket or the contacts of the Ethernet data cable Warning Backfiltration When using Ultraflux filters and selecting low UF rates there is a possibility of local...

Page 44: ...obic filter use a replacement pressure line accessory available from manufacturer If you cannot exclude the possibility that the device may have become contaminated Take the device out of service after completing treatment Have the device tested for contamination by service support If the device is contaminated all affected parts must be disinfected or replaced by service support Warning IV pole D...

Page 45: ...tness before connecting them to the tubing system After the blood pump exit there must not be any clamps placed on the blood line system Warning Delivery operation of the pump s with open doors blood pump substituate pump filtrate pump dialysate pump When the doors are open and the rotor of the pump s is running make sure that no objects such as fingers hair or ballpoint pens come into contact wit...

Page 46: ... at the connections downstream of the air detector negative pressure can permit air to enter into the extracorporeal blood circuit This can be a problem for single needle applications or when using central venous catheters The fluid level of the venous bubble catcher Correct the fluid level if necessary target level approx 1 cm under the upper edge of the cap The tubing system is inserted without ...

Page 47: ...is depends on various factors including the room temperature and the treatment parameters particularly with low dialysate and substituate flow rates or if a heater is intentionally switched off The heater of the device has been designed to heat dialysate or haemofiltration solutions and thus counteracts heat loss As the heating must be limited for safety reasons heat loss can not always be fully c...

Page 48: ...ect the menu fields on the left up to the Treatment modes field where the selection will stop even if you turn the selector further to the left The selected menu must be confirmed by pressing the rotary selector OK The status bar on the screen displays the selected menu In the menu bar the currently selected menu is shown with black characters on a green background 4 2 2 Treatment main screen This...

Page 49: ...u turn the rotary selector further The procedure for entering treatment parameters will be explained starting with the example of the Blood flow After the selected Blood flow parameter has been confirmed with OK the currently selected actual value will be shown in black in the first line of the parameter field and the value to be changed target value will be shown in white in the second line Turni...

Page 50: ...ue must be confirmed by pressing the rotary selector OK After the set value has been confirmed with OK the currently selected actual value will be shown in black in the first line of the parameter field and the new value target value will be shown in yellow in the second line After the new value has been stored by the system it will be displayed in black To enter all other parameters proceed as de...

Page 51: ...ation steps 4 3 1 Entering ultrafiltration UF goal Note The parameter UF goal can only be entered in the Treatment parameters menu If ultrafiltration has not been programmed no UF goal grey background can be entered If ultrafiltration has been programmed a UF goal blue background can be entered ...

Page 52: ... Under Total the system shows the sum of the target goal and the UF volume already removed since treatment start or balance data reset If a UF goal is entered ultrafiltration will be stopped and set to 0 after the UF goal has been achieved Press the START RESET key Press the START RESET key again The alarm limits will be set around the current actual value Exception Venous pressure see chapter 5 5...

Page 53: ...gulation function may be selected both during preparation and during the treatment via the Bolus menu field When changing from preparation to treatment the bolus quantity will be set to 0 Use the rotary selector to select Venous bubble catcher level and press and hold OK until the required level has been reached Use the rotary selector to select Venous bubble catcher level and press and hold OK un...

Page 54: ...ty The maximum angle of inclination must not exceed 5 Before turning the device on please ensure that all scales are unloaded that no objects are placed on the scales and that no tubing system is inserted in the Ci Ca pumps The maximum loading capacity of 12 kg per scale must not be exceeded The weighing cell can even be permanently damaged by a short term overload e g pulling or lifting the devic...

Page 55: ...ce Press the power switch on the rear of the device Tip If used tubing systems are still present in the blood circuit module these can be removed by opening the pump cover and pressing the START RESET key The green LED is illuminated All systems are supplied with voltage The battery is being charged Press the On Off key for approx 3 seconds until the yellow LED is illuminated The processor check s...

Page 56: ...e module fails to pass the functional test even though faults have been eliminated and the functional test has been repeated treatment with the multiFiltrate device is not permitted Note The operator must check all of the status indicator lights during the functional test Functional test will start automatically The progress bar in the status bar shows the progress of the functional test The opera...

Page 57: ...on whether the treatment is to be performed with or without citrate anticoagulation can already be made during the functional test Use the rotary selector to select On or Off and press OK Use the rotary selector to select Continue previous treatment and press OK The last treatment that was performed will remain stored and can be continued with the old parameters Exception The flow rate of the hepa...

Page 58: ...s OK Note On the device the current treatment mode is always displayed in the upper left hand corner of the screen in the status bar For technical reasons the screens shown in the Instructions for Use do not always represent the selected treatment mode Note If citrate anticoagulation is activated only the treatment modes CVVHD and CVVHDF are available Use the rotary selector to select the required...

Page 59: ...assette system or AV set 4 5 2 1 Inserting the cassette system When using an AV set continue with Inserting the arterial blood line system see chapter 4 5 2 2 on page 4 18 Note Each treatment mode has its individual starting conditions The operator must ensure that the starting conditions are met before using the rotary selector to select Conditions fulfilled and pressing OK Insert the cassette sy...

Page 60: ...blood line system 4 5 2 3 Inserting the venous blood line system Insert the arterial blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the venous blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 61: ... the instructions Turn the rotary selector clockwise until the next screen displays Note Depending on the settings the tubing arrangement for dialysate substituate or sub predilution and sub postdilution may differ from the illustration on the screen The device has to be set up in accordance with the instructions on the screen The settings for the tubing system may only be changed by technical ser...

Page 62: ...3 2 Inserting the substituate or sub postdilution tubing system except for CVVHD Insert the dialysate or sub predilution tubing system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the substituate or sub postdilution tubing system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 63: ...e next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting objects or media Blood clots coagula can cause the air bubble detector to fail Note Ensure t...

Page 64: ...nt Confirm the completely inserted tubing system using the rotary selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Use the rotary selector to select Start priming OK to confirm and press OK Heparin can be added t...

Page 65: ...tered the bolus function can be used The ultrasonic sensor detects fluid in the venous bubble catcher Set the venous level manually using the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary selector to select the required treatment p...

Page 66: ...nge the existing connection Use the rotary selector to select Start UF rinse OK to confirm and press OK Indication of the decreasing UF volume and the remaining rinse time Turn the filter upon notification Note The filter life which is shown in the status bar is automatically added to the service life of the tubing systems When the UF volume reaches 0 ml the extracorporeal blood circuit is in reci...

Page 67: ...ng an NaCl solution with two connectors Disconnect the arterial patient line from the NaCl solution and connect it to the arterial vascular access or Connect the arterial and venous patient line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to confirm ...

Page 68: ...Note Once treatment has started and the blood pump has achieved its target delivery rate the alarm limits are set automatically after approx 10 seconds Following this the pressure alarm limits must be checked by the operator and adjusted individually as required The main screen is displayed throughout the entire treatment Depending on the treatment mode the menu field shows The current pressures a...

Page 69: ... menu fields shown depend on the selected treatment mode Detailed description see chapter 4 11 on page 4 104 After a timeout the display will automatically return to the treatment main screen Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK The treatment parameters shown depend on the selected treatment mode After a timeout the display will au...

Page 70: ... is possible to stop a flow during the treatment in the CVVHDF and Pre Post CVVH treatment modes Only a CVVH or CVVHD will then be performed in the CVVHDF for example This change of procedure can be undone The changed treatment mode is shown in the status bar The letter which is greyed out indicates a change of procedure Use the rotary selector to select Dialysate and set it to Off Note Sub bolus ...

Page 71: ...tuate and set it to Off Warning The storage life for opened solution bags indicated by the manufacturer must be observed If the storage life has been exceeded the solutions must not be used anymore Substituate or dialysate must remain deactivated or the end of the treatment has to be initiated Use the rotary selector to select Substituate or Dialysate and set the required flow ...

Page 72: ...key Press the STOP key for approx 3 seconds The venous clamp closes The blood pump is stopped or Use the ESC key to select a different menu from the menu bar Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the rotary selector to select Start disconnection OK to confirm and press OK When selectin...

Page 73: ...irm will display the treatment parameters The optical detector senses non opaque fluid When selecting Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid ...

Page 74: ... Press and hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segment by slightly pulling on it Remove the heater bag depending on the treatment mode from the heater Open the clamps before and after the heater bag to facilitate removal of the bag Remove and dispose of the tubing system To remove the remaining pump segments proceed as describ...

Page 75: ...us bar shows CVVHD Ci Ca or CVVHDF Ci Ca Post as treatment mode If the Ci Ca module is selected it is shown in white characters If the Ci Ca module is deselected Ci Ca is shown in grey Warning Please be absolutely sure that the citrate and or calcium concentrations as well as the citrate and or calcium volume of the solutions used comply with the settings in the Setup menu of the multiFiltrate The...

Page 76: ...e until the next screen displays Warning When inserting the citrate and calcium tubes ensure that the tube segments and reservoirs for the solutions concerned are properly locked and assigned Warning The citrate and calcium solutions must be at room temperature before they can be used Note The following requirements must be fulfilled before inserting the Ci Ca pump segments to be able to perform a...

Page 77: ...instructions Turn the rotary selector clockwise until the next screen displays Warning Please ensure that the dialysate substitution fluid used is suitable for the selected Ci Ca treatment Note Depending on the settings the dialysate and substituate tubing arrangement may differ from the illustration on the screen The device has to be set up in accordance with the instructions on the screen The se...

Page 78: ...ording to the instructions Turn the rotary selector clockwise until the next screen displays Warning A Ci Ca postCVVHDF treatment may only be performed if a calcium containing HF solution is used Note For a Ci Ca postCVVHDF treatment the substituate line must always be connected to the postdilution port Insert the substituate tubing system according to the instructions Turn the rotary selector clo...

Page 79: ...kwise until the next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting objects or media Blood clots coagula can cause the air bubble detector to fail...

Page 80: ...selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Open the white and green clamps on the Ci Ca lines and if present break the cones of the solution bags Due to the negative pressure the drip chambers are automatic...

Page 81: ...Filtrate Citrate anticoagulation cannot be deselected before the Ci Ca lines are filled completely The filling level of the Ci Ca lines can be readjusted Use the rotary selector to select Refill citrate or Refill calcium and press OK The particular pump will run for one revolution This procedure can be repeated as often as required Once the Ci Ca lines are primed while being free from air use the ...

Page 82: ...the NaCl solution used for priming and rinsing via the Bolus menu field Open the infusion extraction point to prime the arterial bubble catcher If the amount of air in the arterial bubble catcher has decreased to a level of approx 1 cm underneath the lid the infusion extraction point has to be closed Warning Please ensure that the ratios of blood flow to dialysate flow substituate flow are properl...

Page 83: ...g the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary selector to select the required treatment parameters green background and press OK The possible entries depend on the selected treatment mode Use the rotary selector to enter the ...

Page 84: ...ot change the existing connection Use the rotary selector to select Start UF rinse OK to confirm and press OK Indication of the decreasing UF volume and the remaining rinse time Turn the filter upon notification Note The filter life which is shown in the status bar is automatically added to the service life of the tubing systems When the UF volume reaches 0 ml the extracorporeal blood circuit is i...

Page 85: ...nect it to the arterial vascular access or Connect the arterial and venous patient line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to confirm and press OK The blood pump will deliver at the programmed rate Settable rate 10 ml min to 100 ml min defau...

Page 86: ...firm and press OK Note Once treatment has started and the blood pump has achieved its target delivery rate the alarm limits are set automatically after approx 10 seconds Following this the pressure alarm limits must be checked by the operator and adjusted individually as required Warning When starting the treatment define the post filter calcium value If the ionised calcium has not decreased at th...

Page 87: ...he post filter calcium concentration now The main screen is displayed throughout the entire treatment Depending on the treatment mode the menu field shows The current pressures arterial venous TMP The current flow rates dialysate substituate in postdilution blood flow ultrafiltration Citrate blood dose and citrate flow Calcium filtrate dose and calcium flow Heparin The status bar shows The treatme...

Page 88: ...d press OK The menu fields shown depend on the selected treatment mode Detailed description see chapter 4 11 on page 4 104 After a timeout the display will automatically return to the treatment main screen Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK The treatment parameters shown depend on the selected treatment mode After a timeout the d...

Page 89: ... opaque fluid but for no longer than 10 min Stop the treatment by pressing the STOP key Press the STOP key for approx 3 seconds The venous clamp closes The blood pump is stopped or Use the ESC key to select a different menu from the menu bar Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the ro...

Page 90: ...ing Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK The citrate pump stops but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid The citrate pump stops Warning It is forbidden to remove the Ci Ca lines manually befo...

Page 91: ...revolutions Support the removal of the pump segment by slightly pulling on it If a Ci Ca pump segment cannot be removed completely press the pump segment adapter into the appropriate pump once again and repeat the removal process Remove the pump segment adapter from the groove Press and hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segm...

Page 92: ...esenius Medical Care multiFiltrate IFU EN UK 15A 2015 CRRT treatments with citrate anticoagulation 4 6 10 Treatment history Indication of the treatment parameters for the entire treatment Press the I O key to turn the device off ...

Page 93: ...he AV set 4 7 2 1 Inserting the arterial blood line system Note The multiFiltrate paed CRRT SCUF set tubing system has to be used for paediatric CVVH and CVVHD treatment modes The status bar shows Paed CVVHD or Paed CVVH as the treatment mode Note Each treatment mode has its individual starting conditions The operator must ensure that the starting conditions are met before using the rotary selecto...

Page 94: ... 3 Inserting further tubing systems Depending on the selected treatment mode the tubing system for dialysate or substituate has to be inserted Insert the venous blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the filtrate line system according to the instructions Turn the rotary selector clockwise until the next screen displa...

Page 95: ...bstituate tubing arrangement may differ from the illustration The device has to be set up in accordance with the instructions on the screen The settings for the tubing system may only be changed by technical service support Insert the dialysate tubing system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the substituate tubing system accordin...

Page 96: ...il the next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting objects or media Blood clots coagula can cause the air bubble detector to fail Note Ens...

Page 97: ...angement Confirm the completely inserted tubing system using the rotary selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Use the rotary selector to select Start priming OK to confirm and press OK Heparin can be a...

Page 98: ... venous level manually using the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary selector to select the required treatment parameters green background and press OK The possible entries depend on the selected treatment mode Use the ro...

Page 99: ...ot change the existing connection Use the rotary selector to select Start UF rinse OK to confirm and press OK Indication of the decreasing UF volume and the remaining rinse time Turn the filter upon notification Note The filter life which is shown in the status bar is automatically added to the service life of the tubing systems When the UF volume reaches 0 ml the extracorporeal blood circuit is i...

Page 100: ... using an NaCl solution with two connectors Disconnect the arterial patient line from the NaCl solution and connect it to the arterial vascular access or Connect the arterial and venous patient line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to conf...

Page 101: ...ss OK Note Once treatment has started and the blood pump has achieved its target delivery rate the alarm limits are set automatically after approx 10 seconds Following this the pressure alarm limits must be checked by the operator and adjusted individually as required The main screen is displayed throughout the entire treatment Depending on the treatment mode the menu field shows The current press...

Page 102: ...K The menu fields shown depend on the selected treatment mode Detailed description see chapter 4 11 on page 4 104 After a timeout the display will automatically return to the treatment main screen Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK The treatment parameters shown depend on the selected treatment mode After a timeout the display wi...

Page 103: ...TOP key Press the STOP key for approx 3 seconds The venous clamp closes The blood pump is stopped or Use the ESC key to select a different menu from the menu bar Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the rotary selector to select Start disconnection OK to confirm and press OK When sele...

Page 104: ...o confirm will display the treatment parameters The optical detector senses non opaque fluid When selecting Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid ...

Page 105: ...nd hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segment by slightly pulling on it Remove the heater bag depending on the treatment mode from the heater Open the clamps before and after the heater bag to facilitate removal of the bag Remove and dispose of the tubing system To remove the remaining pump segments proceed as described above...

Page 106: ...re that the starting conditions are met before using the rotary selector to select Conditions fulfilled and pressing OK Note Where plasma filters are supplied dry not pre filled it is not necessary to fill the arterial tubing system before connecting this up to the filter In contrast to the instructions shown on the screen the arterial tubing system can be connected directly to the filter If the f...

Page 107: ...terial blood line system 4 8 2 3 Inserting the venous blood line system Insert the arterial blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the venous blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 108: ...erting the filtrate line system 4 8 3 Inserting the plasma line system Insert the filtrate line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the plasma line system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 109: ...ntil the next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting objects or media Blood clots coagula can cause the air bubble detector to fail Note E...

Page 110: ...rrangement Confirm the completely inserted tubing system using the rotary selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Use the rotary selector to select Start priming OK to confirm and press OK Heparin can be...

Page 111: ...initial heparin dose is to be administered the bolus function can be used The ultrasonic sensor detects fluid in the venous bubble catcher Set the venous level manually using the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary select...

Page 112: ...ion If using an NaCl solution with one connector Do not change the existing connection Use the rotary selector to select Start UF rinse OK to confirm and press OK Note The filter life which is shown in the status bar is automatically added to the service life of the tubing systems When the UF volume reaches 0 ml the extracorporeal blood circuit is in recirculation If using an NaCl solution with tw...

Page 113: ... M28 004 1 can be used if required Stop recirculation by pressing the STOP key Press the STOP key for approx 3 seconds It is imperative to enter the net volume of the replacement solution Use the rotary selector to select Start filling plasma OK to confirm and press OK The blood pump will deliver at the programmed rate Settable rate 10 ml min to 100 ml min default 100 ml min Time controlled fillin...

Page 114: ...ent line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to confirm and press OK The optical detector senses opaque fluid The blood pump is stopped If not done yet when using an NaCl solution with two connectors Disconnect the venous patient line from th...

Page 115: ...is displayed throughout the entire treatment Depending on the treatment mode the menu field shows The current pressures arterial venous TMP The current flow rates plasma blood flow ultrafiltration Heparin The status bar shows The treatment mode Plasma on scale II The balance Continuous anticoagulation on off Press the ESC key Use the rotary selector to select Treatment from the menu bar and press ...

Page 116: ...nge Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK After a timeout the display will automatically return to the treatment main screen The scales alert the operator that the plasma bag will need to be replaced in 5 minutes Press the ESC key Use the rotary selector to select Treatment from the menu bar and press OK ...

Page 117: ...asma separation MPS Use the rotary selector to select Change bag and press OK Use the rotary selector to select Plasma volume and press OK It is imperative to enter the new net volume of the replacement solution Use the rotary selector to select Terminate bag change OK to confirm and press OK ...

Page 118: ...emaining plasma The plasma is returned via the Change bag menu Confirm the message by pressing the START RESET key Use the rotary selector to select Plasma return and press OK Use the rotary selector to select Start plasma return OK to confirm and press OK The residual plasma of approx 300 ml will be administered until the Balancing message is displayed ...

Page 119: ...s The venous clamp closes The blood pump is stopped Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the rotary selector to select Start disconnection OK to confirm and press OK When selecting Disconnect without blood return the program will go directly to Disconnecting the patient without reinfu...

Page 120: ... to confirm will display the treatment parameters The optical detector senses non opaque fluid When selecting Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid ...

Page 121: ... adapter from the groove Press and hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segment by slightly pulling on it Remove the heater bag depending on the treatment mode from the heater Open the clamps before and after the heater bag to facilitate removal of the bag Remove and dispose of the tubing system To remove the remaining pump seg...

Page 122: ...rting the arterial blood line system Note The multiFiltrate paed CRRT SCUF set tubing system part no 501 775 1 has to be used for the SCUF treatment mode Note Each treatment mode has its individual starting conditions The operator must ensure that the starting conditions are met before using the rotary selector to select Conditions fulfilled and pressing OK Insert the arterial blood line system ac...

Page 123: ...ng the venous blood line system 4 9 2 3 Inserting the filtrate line system Insert the venous blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the filtrate line system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 124: ...e until the next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting objects or media Blood clots coagula can cause the air bubble detector to fail Not...

Page 125: ...g arrangement Confirm the completely inserted tubing system using the rotary selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Use the rotary selector to select Start priming OK to confirm and press OK Heparin can...

Page 126: ... the venous bubble catcher Set the venous level manually using the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary selector to select the required treatment parameters green background and press OK Use the rotary selector to enter th...

Page 127: ... Do not change the existing connection Use the rotary selector to select Start UF rinse OK to confirm and press OK Indication of the decreasing UF volume and the remaining rinse time Turn the filter upon notification Note The filter life which is shown in the status bar is automatically added to the service life of the tubing systems When the UF volume reaches 0 ml the extracorporeal blood circuit...

Page 128: ...ors Disconnect the arterial patient line from the NaCl solution and connect it to the arterial vascular access or Connect the arterial and venous patient line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to confirm and press OK The blood pump will del...

Page 129: ... treatment OK to confirm and press OK Note Once treatment has started and the blood pump has achieved its target delivery rate the alarm limits are set automatically after approx 10 seconds Following this the pressure alarm limits must be checked by the operator and adjusted individually as required The main screen is displayed throughout the entire treatment Depending on the treatment mode the me...

Page 130: ... Treatment from the menu bar and press OK The menu fields shown depend on the selected treatment mode Detailed description see chapter 4 11 on page 4 104 After a timeout the display will automatically return to the treatment main screen Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK After a timeout the display will automatically return to th...

Page 131: ...the STOP key Press the STOP key for approx 3 seconds The venous clamp closes The blood pump is stopped or Use the ESC key to select a different menu from the menu bar Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the rotary selector to select Start disconnection OK to confirm and press OK When...

Page 132: ... OK to confirm will display the treatment parameters The optical detector senses non opaque fluid When selecting Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid ...

Page 133: ...ent adapter from the groove Press and hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segment by slightly pulling on it Remove the heater bag depending on the treatment mode from the heater Open the clamps before and after the heater bag to facilitate removal of the bag Remove and dispose of the tubing system To remove the remaining pump ...

Page 134: ...on in the accompanying documents for the adsorber used must also be observed Note Each treatment mode has its individual starting conditions The operator must ensure that the starting conditions are met before using the rotary selector to select Conditions fulfilled and pressing OK Note If a cassette is used for HP treatment therapy the filtrate line system has to be inserted but will not be taken...

Page 135: ... blood line system 4 10 2 3 Inserting the venous blood line system Insert the arterial blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays Insert the venous blood line system according to the instructions Turn the rotary selector clockwise until the next screen displays ...

Page 136: ...he heparin syringe according to the instructions Turn the rotary selector clockwise until the next screen displays Note on C The syringe wings must be placed in the syringe wing slot Note on D The thumbplate of the syringe plunger must be positioned between the clamps of the grip handle Warning Patient hazard air embolism The air detector must be clean and dry Do not use any ultrasound conducting ...

Page 137: ...ment Confirm the completely inserted tubing system using the rotary selector to select Set up OK to confirm and press OK Note The patient must not be connected during preparation If the optical detector senses opaque fluid during the preparation phase the system asks whether a patient has been connected Use the rotary selector to select Start priming OK to confirm and press OK Heparin can be added...

Page 138: ...l heparin dose is to be administered the bolus function can be used The ultrasonic sensor detects fluid in the venous bubble catcher Set the venous level manually using the Venous bubble catcher level menu field Rinsing starts automatically and the screen for entering the treatment parameters appears Indication of the decreasing rinse volume and the remaining rinse time Use the rotary selector to ...

Page 139: ...f the tubing systems After the rinse is completed and the pre defined volume used the blood pump will stop Audible signal If using an NaCl solution with two connectors Disconnect the venous patient line from the empty bag and connect it to the NaCl solution If using an NaCl solution with one connector Connect the venous patient line to the arterial patient line using the recirculator Continue reci...

Page 140: ...nnect the arterial patient line from the NaCl solution and connect it to the arterial vascular access or Connect the arterial and venous patient line to the vascular access If using an NaCl solution with one connector Connect the arterial and venous patient line to the vascular access and Use the rotary selector to select Start connection OK to confirm and press OK The blood pump will deliver at t...

Page 141: ... Start treatment OK to confirm and press OK Note Once treatment has started and the blood pump has achieved its target delivery rate the alarm limits are set automatically after approx 10 seconds Following this the pressure alarm limits must be checked by the operator and adjusted individually as required The main screen is displayed throughout the entire treatment Depending on the treatment mode ...

Page 142: ...nt from the menu bar and press OK The menu fields shown depend on the selected treatment mode Detailed description see chapter 4 11 on page 4 104 After a timeout the display will automatically return to the treatment main screen Press the ESC key Use the rotary selector to select Treatment parameters from the menu bar and press OK After a timeout the display will automatically return to the treatm...

Page 143: ... key Press the STOP key for approx 3 seconds The venous clamp closes The blood pump is stopped or Use the ESC key to select a different menu from the menu bar Continue the treatment by pressing the START RESET key or Disconnect the arterial patient line from the patient and connect it to the NaCl solution Use the rotary selector to select Start disconnection OK to confirm and press OK When selecti...

Page 144: ...nfirm will display the treatment parameters The optical detector senses non opaque fluid When selecting Continue reinfusion the remaining reinfusion volume can be returned to the patient or Use the rotary selector to select Terminate reinfusion and press OK but The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non opaque fluid ...

Page 145: ...nnect the venous patient line from the patient Remove the pump segment adapter from the groove Press and hold the START RESET key until the pump segment has been completely removed Support the removal of the pump segment by slightly pulling on it Remove and dispose of the tubing system To remove the remaining pump segments proceed as described above Use the rotary selector to select View treatment...

Page 146: ... parameter field from the menu field and press OK After a timeout the display will automatically return to the treatment main screen Warning After deselecting citrate anticoagulation the operator has to ensure an alternative anticoagulation procedure Warning After deselecting citrate anticoagulation the CVVHD treatment may only be continued performed if a calcium containing HF solution dialysate i...

Page 147: ... OK to confirm and press OK After deselecting citrate anticoagulation the multiFiltrate immediately switches to the menu for dialysate bag change Warning Ci Ca CVVHD and Ci Ca postCVVHDF treatments may only be performed if calcium free dialysate is used Warning When starting the treatment define the post filter calcium value If the ionised calcium has not decreased at this point it is absolutely n...

Page 148: ...nificantly please consult a physician Observe the instructions on taking a sample see chapter 7 3 2 on page 7 17 Use the rotary selector to select Yes from the menu field and press OK Use the rotary selector to select All conditions fulfilled OK to confirm and press OK After selecting citrate anticoagulation the multiFiltrate immediately switches to the menu for dialysate bag change ...

Page 149: ...he required HF solution Not active red the deactivated scales The current weight on the filtrate scales Place the solution bag in question on the scales or replace it and or empty the filtrate bag In the event of presence of air in one of the tubing systems disconnect the corresponding outlet Use the rotary selector to select Deaeration XXX and press and hold OK until all air has been removed from...

Page 150: ... Change bag menu If the bag change lasts longer than 2 minutes citrate pump stopped for more than 2 minutes an alarm will be emitted Use the rotary selector to select Citrate bag change or Calcium bag change from the menu field and press OK On selection of Citrate bag change the citrate pump will be stopped The calcium pump has already been stopped Replace the solution bag in question Break the co...

Page 151: ... the treatment mode Note The syringe change menu can be accessed Manually by selecting the Syringe change menu Automatically after a syringe change notification Perform the syringe change according to the instructions Use the rotary selector to select Terminate syringe change OK to confirm from the menu field and press OK Note on C The syringe wings must be placed in the syringe wing slot Note on ...

Page 152: ... completely removed by the filtrate pump The rotary selector can be used to select the following pressure graphs and to confirm the selection with OK 0 no pressure graphs Art arterial pressure graph Ven venous pressure graph TMP pressure graph showing pressure in the filter Filter pressure graph showing pressure before the filter Filtrate pressure graph showing pressure on the filtrate side All Ar...

Page 153: ...f one hour the balance is 2 2 l The following has to be observed The balance will be negative if fluid is removed from the patient The balance will only be positive if the bolus volume is higher than the UF volume The balance will normally be either even or negative 4 11 7 2 Balance data during the treatment Menu field Switch balancing on off Reset balance data A balance data reset will reset all ...

Page 154: ... rotary selector to select Start time and End time and press OK Enter times and press OK to confirm The balance data of the period of time entered is calculated automatically and displayed The balance data within a period of time of the previous treatment can be displayed Use the rotary selector to select Start time and End time and press OK Enter times and press OK to confirm The balance data of ...

Page 155: ...ltrate IFU EN UK 15A 2015 4 113 Treatment menu 4 11 7 5 Total balance after the treatment 4 11 7 6 Balance since reset Indication of the treatment parameters for the entire treatment The balance data since the last balance data reset will be displayed ...

Page 156: ...he pressure limits will be reduced accordingly The absolute lower alarm limit for venous pressure during treatment is 10 mmHg The lower pressure limit is adjusted accordingly Following this the pressure limits should be checked by the operator and adjusted individually as required Note The system will only adopt a target and set change of the alarm limit window width alarm limit window position af...

Page 157: ...mit must be set as close as possible to the actual venous pressure value Changing the alarm limit window position or width can adversely affect or even cancel out the efficiency of the safety system in identifying extraneous blood loss Use the rotary selector to select Venous width and press OK Use the rotary selector to enter the required window width and press OK Use the rotary selector to selec...

Page 158: ... if the mains power supply is interrupted Use the rotary selector to select Page or Line and press OK to confirm This will activate the detailed view The detailed view in the lower part of the screen displays the text messages for warnings yellow and alarms red Use the rotary selector to scroll the events page by page or line by line Use the rotary selector to select Page and press OK to confirm T...

Page 159: ...t after another will be displayed when turning the rotary selector Use the rotary selector to select Sub bolus 100 ml and press OK 100 ml of substitution fluid will be administered to the patient The bolus will be included in the calculation of the balance Sub bolus cannot be administered in Balancing off and the following treatment modes Ci Ca CVVHD CVVHD HP SCUF MPS Paed CVVHD and Paed CVVH ...

Page 160: ... Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 Treatment menu The upper venous alarm limit is set to 300 mm Hg The lower TMP alarm limit is set to 60 mm Hg The bolus can be stopped at any time by selecting Stop bolus ...

Page 161: ... where no selection is possible then the menu field is greyed out Tubing arrangement When Detailed is selected the installation of the line system will be shown step by step When Complete is selected the fully inserted line system will be displayed Note The responsible organisation should define the most important configurable parameter settings itself or confirm the default values and have these ...

Page 162: ...settings 4 12 2 Setting the date time Standard parameters can be entered for each treatment mode These can be changed individually for each patient in the Treatment parameters menu The parameters that were changed are not activated until the device is brought back into operation with the I O key Set the current date and time ...

Page 163: ...eactivate balancing The citrate infusion has to be stopped actively with Deselect Ci Ca anticoagulation If the internal heparin pump is used for systemic anticoagulation it also must be stopped If you proceeded in this manner discard the blood in the extracorporeal circuit and if necessary replace it with isotonic NaCl solution before reconnecting the patient The stopped anticoagulation process mu...

Page 164: ...connecting the patient and perform the process with due care to avoid any loss of blood Set the blood flow to 100 ml min and turn the heparin pump off Stop the treatment by pressing the STOP key Press the STOP key for approx 3 seconds Disconnect the arterial patient line from the patient and connect it to the NaCl solution Press the START RESET key When the optical detector senses non opaque fluid...

Page 165: ...connect the arterial patient line from the NaCl solution and connect it to the arterial vascular access Press the START RESET key When the optical detector senses opaque fluid disconnect the venous patient line from the NaCl solution and connect it to the venous vascular access Continue the treatment by pressing the START RESET key Balancing starts automatically Ci Ca pumps start automatically If ...

Page 166: ...Chapter 4 Operation 4 124 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 Interrupting the treatment ...

Page 167: ...t hazard through repeatedly acknowledging a message Always correct the problem that caused the message before acknowledging it Note When alarms and warnings occur follow the information given in the messages as well as any explanations given in the Help function Alarms warnings Possible patient hazard Loss of pressure at the venous vascular access Arterial and venous pressure alarms Extraneous blo...

Page 168: ...ion The Old alarm scheme displays a condition oriented system of alarms and corresponds to the former alarm schemes provided by the Fresenius Medical Care range of devices The New alarm scheme displays the potential danger presented by an alarm situation It assigns a priority to every alarm and is based on the alarm standard EN 60601 1 8 for medical devices used in intensive medical care 5 2 1 Old...

Page 169: ...ted tone sequence of 3 beeps Low priority Yellow steady operating status indicator and repeated tone sequence of 2 beeps The system also offers the option of providing information Warning Green flashing operating status indicator with repeated tone and isolated information tones In this way each alarm scenario is assigned a priority that defines the alarm response of the device 5 3 High priority a...

Page 170: ... be deactivated in the Treatment menu It is not possible to override the air alarm 5 5 Alarm system Pressure monitoring To avoid unnecessary false alarms the monitoring window can be temporarily extended disabled or its levels adjusted to the current pressure following changes to relevant parameters pressure alarms or issuing pump stop start commands These conditions are time limited Monitoring at...

Page 171: ...iority are not signaled by the system Follow up alarms of higher priority are signaled in cases where the system has not already reached a safe condition Audible alarm suppression mute Silencing the audible alarm will always suppress an alarm for a duration of 2 minutes Any new alarm that occurs will activate the silenced audible alarm ...

Page 172: ...r to suppress deactivate the audible tone of a signaled alarm for a certain period of time If a new alarm occurs during this time the audible alarm tone of the new alarm is signaled regardless Alarm Response Arterial pressure Alarm limits widened to maximum values for the duration of the pump start up approx 10 seconds Venous pressure Alarm limits widened to maximum values for the duration of the ...

Page 173: ...n the messages as well as any explanations given in the Help function If alarms are repeatedly acknowledged without resolving their causes this can endanger the patient Each display message is identified by a number on the upper right corner This number will enable the service to provide faster assistance in the event of a problem Selecting the button will display additional support on how to corr...

Page 174: ... alert the operator to incorrect operation or a malfunction The warning message is shown on the title bar yellow or grey background depending on the alarm scheme configured The lower section of the box white background contains a summarised description of the possible cause Balance is off By selecting the green question mark with the rotary selector and pressing OK the operator will obtain support...

Page 175: ...operator to an alarm The alarm message is shown on the title bar yellow or red background depending on the alarm scheme configured The lower section of the box white background contains a summarised description of the possible cause Balance is off The blood pump is stopped By selecting the green question mark with the rotary selector and pressing OK the operator will obtain support in correcting t...

Page 176: ...pump will start at a slower speed and gradually increase to the prescribed rate Then the required balancing pumps will start depending on the treatment mode If the functional test could not be completed successfully a warning indicating an error number will be displayed on the screen Repeat the functional test by pressing the START RESET key Note If the functional test was not passed even after ha...

Page 177: ...e Arterial pressure The alarm limits are flashing The pressure display is red The blood pump is stopped Use the rotary selector to select the green question mark and press OK The possible causes will be displayed Correct the condition causing the alarm Press the START RESET key The blood pump will start at a slower speed and gradually increase to the prescribed rate Then the required balancing pum...

Page 178: ...ation with low blood flow rates may lead to an inadequate concentration of blood in the haemofilter massive increase of the TMP To a great extent the blood concentration required depends on the individual haemofilter For this reason there is a general risk of clotting in the capillaries To avoid this reaction it is advisable to set the UF rate in postdilution so as not to exceed 20 of the BP rate ...

Page 179: ...ion CVVHDF with predilution and postdilution Pre Post CVVH with postdilution Ci Ca postCVVHDF with postdilution MPS with postdilution With predilution haemoconcentration of the blood will not occur This warning can be confirmed with the START RESET key provided the treatment is performed in predilution or the imbalance in postdilution is required It is advisable to correct this imbalance by changi...

Page 180: ...tion used which is defined in the Setup menu of the multiFiltrate The calcium flow is limited by the control range of the calcium pump Control range of the calcium pump 10 100 ml h If the respective settings of the various flows and the required calcium dose result in a calcium flow outside the pump control range a warning will be emitted The operator now has to adjust the waste volume appropriate...

Page 181: ...e pump Control range of the citrate pump 10 600 ml h If the settings of the initial values result in a citrate flow outside the pump control range a warning will be emitted The operator now has to adjust the blood flow or if necessary the citrate dose to continue the treatment Press the START RESET key in order to override the warning for 2 minutes Adjust the settings accordingly Note If the modif...

Page 182: ...e The blood leak detector is the safety system which monitors haemolysis and blood leaks For plasma separation procedures it is possible to deactivate the blood leak detector for the duration of the current treatment The blood leak detector is reactivated when the device is switched on again Warning Patient hazard due to haemolysis or blood loss If the blood leak detector has been overridden deact...

Page 183: ...p is started The override time for the blood leak detector is 2 minutes The blood leak detector can be deactivated for MPS during the override time in the Treatment menu Deactivate the blood leak detector with the Blood leak detector button After the safety prompt to deactivate the blood leak detector has been confirmed with Yes the blood leak detector no longer monitors for haemolysis or blood lo...

Page 184: ...g Citrate pump continues running for up to 10 minutes then alarm due to switched off balance The calcium pump is stopped An audible signal will be given When power is restored the system will start automatically End of emergency operation is displayed Balance is off The blood pump is stopped The extracorporeal blood volume must be returned using a hand crank see chapter 5 15 on page 5 19 ...

Page 185: ... avoid the risk of an air infusion Note The maximum time for emergency operation may be reduced due to the increased power requirements of the Ci Ca module Switch off the device using the On Off key This will make the blood pump rotor easier to turn Disconnect the arterial patient line and connect it to the NaCl solution Break the cone Remove the venous patient line from the venous clamp Visually ...

Page 186: ...Chapter 5 Alarm processing 5 20 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 187: ...he manufacturers of the disinfectants at the time of publishing these Instructions for Use Always check the application concentration against the current product information of the disinfectants Incidin Extra N Active substance base aldehyde free preparation Type of disinfection wipe disinfection ClearSurf Active substance base cationic surfactants Type of disinfection wipe disinfection Freka NOL ...

Page 188: ...Chapter 6 Cleaning disinfection 6 2 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 189: ...ons in the balancing system e g unexpected change of the weight on one of the scales Handling The operating concept with its clear menu structure allows for easy operation Treatment parameters and softkeys are displayed on a large screen The device is operated with a rotary selector and additional keys e g to select fields displayed on the screen Functional test An automatic functional test which ...

Page 190: ...etting up the system The haemofiltration can simultaneously be performed in predilution and postdilution Pre Post CVVH It is also possible to perform a haemodialysis CVVHD as an alternative Haemofiltration and haemodialysis can be combined as haemodiafiltration CVVHDF Depending on the infusion site of the substituate the therapy is called Predilution CVVHDF or Postdilution CVVHDF Pre CVVHDF and Po...

Page 191: ...CVVH If the same volume of substituate is used predilution is less effective than postdilution The disadvantage caused by this dilution can be reduced by increasing the blood flow rate It is also possible to select another CRRT treatment as an alternative Treatment parameters Fig CVVH flow diagram CVVH adults Min Max Resolution Unit Blood flow 10 500 10 ml min Ultrafiltration Off 10 1800 10 ml h U...

Page 192: ...ales 3 and 4 9 Predilution 10 Postdilution 11 Check valve 12 Heater 13 Substituate pump 14 Scales 1 and 2 15 Substituate Treatment parameters Pre Post CVVH Min Max Resolution Unit Blood flow 10 500 10 ml min Ultrafiltration Off 10 1200 10 ml h UF goal Off 50 10 000 50 ml Cont heparin adm Off 0 1 25 0 1 ml h Sub predilution Off 600 4800 50 ml h Sub postdilution Off 600 4800 50 ml h Temperature Off ...

Page 193: ... Blood pump 2 Haemofilter 3 Air detector 4 Venous clamp 5 Filtrate pump 6 Blood leak detector 7 Filtrate 8 Scales 3 and 4 9 Predilution 10 Postdilution 11 Check valve 12 Heater 1 13 Substituate pump 1 14 Scale 2 15 Substituate 16 Heater 2 17 Substituate pump 2 18 Scale 1 19 Substituate 1 2 4 3 5 6 7 8 10 9 14 15 13 12 11 16 17 18 19 ...

Page 194: ...t CVVH procedure As the speed of diffusion is relative to the molecular weight the full saturation of the dialysate with larger middle molecular weight solutes may not be achieved depending on the blood and dialysate flow rates set The clearance rate achieved for these substances is thus lower than with Post CVVH if the same dialysate and substituate quantities are used This disadvantage of CVVHD ...

Page 195: ...ctor 4 Venous clamp 5 Filtrate pump 6 Blood leak detector 7 Filtrate 8 Scales 3 and 4 9 Heater 10 Dialysate pump 11 Scales 1 and 2 12 Dialysate Combination of the basic treatments CVVHDF These three basic treatments can be combined in pairs Pre CVVH CVVHD Pre CVVHDF Post CVVH CVVHD Post CVVHDF Pre CVVH Post CVVH Pre Post CVVH P P P P 1 2 4 3 5 6 7 8 9 10 11 12 ...

Page 196: ...e achievable blood flow and still keep haemoconcentration in the filter to within acceptable limits The dialysis component of a Post CVVHDF procedure further increases the treatment efficacy without additional blood flow requirements as the filtration fraction UFR BPR is not affected by this Fig CVVHDF flow diagram Legend 1 Blood pump 2 Haemofilter 3 Air detector 4 Venous clamp 5 Filtrate pump 6 B...

Page 197: ...he filter used a reduction of the middle molecular clearance is possible if dialysate is used see above Coagulation risk in CRRT treatments The risk of coagulation in the extracorporeal blood circuit is different in the individual CRRT treatments With postdilution there is a haemoconcentration of the blood at the filter outlet depending on the ratio of the filtrate flow to the blood flow and on th...

Page 198: ...ved from the recommendations for the treatment of adults by scaling in accordance with the body surface for example Chadha et al chapter 13 4 no 11 for example used a CRRT dose of 2 l h 1 73 m body surface multiplied with the estimated body surface of the patient following the recommendation of Ronco et al to use a dose of at least 2 l h for a typical adult with a body weight of 70 kg The value 1 ...

Page 199: ... be removed with the highly permeable membranes of special plasma filters due to their size or specific binding to large plasma proteins such as albumin Autoimmune diseases such as Guillain Barré syndrome are an example of the group of diseases for which the removal of autoantibodies by TPE is an accepted therapeutic option In some cases the treatment envisages a replacement of plasma components b...

Page 200: ...ove the pathologic plasma components but also to reinfuse normal plasma components with the replacement solution Here the use of FFP as the replacement solution is recommended or alternatively cryoprecipitate plasma Efficacy During MPS typically one to two times the patient s plasma volume is exchanged Due to the decrease in plasma concentration in the substances to be removed in the course of the...

Page 201: ...5A 2015 7 13 Fig MPS flow diagram Legend 1 Blood pump 2 Haemofilter 3 Air detector 4 Venous clamp 5 Filtrate pump 6 Blood leak detector 7 Filtrate 8 Scales 3 and 4 9 Check valve 10 Heater 1 11 Heater 1 12 Substituate pump 13 Scale 2 14 Plasma P P P P 1 2 4 3 5 6 7 8 9 10 11 12 13 14 ...

Page 202: ...r treatment reinfused into a vein of the patient Usually a large bore central venous double lumen catheter is used for the vascular access Extracorporeal blood circuit For SCUF the blood pump maintains the extracorporeal blood circuit and the filtrate pump ensures the gravity controlled removal of the necessary ultrafiltration volume No substituate is infused nor is any dialysate used Treatment pa...

Page 203: ...ilter pressure between the blood pump and the adsorber cartridge Adsorber cartridge The patient is connected as usual to an extracorporeal circuit that is driven by a blood pump Instead of flowing through a dialyser the blood passes through an adsorber cartridge filled for example with small sorbent particles The arrangement of the sorbent material serves to increase the adsorption surface Inlet a...

Page 204: ...coagulation The selection and dosage of the suitable substance are determined by the physician Depending on the substance different laboratory parameters are used to control the dosage The aPTT activated partial thromboplastin time for example is a suitable parameter to assess the effect of unfractionated heparin in principle Integrated heparin pump for anticoagulation A heparin pump for the conti...

Page 205: ...ncrease of the systemic citrate concentration CVVHD with citrate anticoagulation Min Max Resolution Unit Blood flow 10 200 10 ml min Ultrafiltration Off 10 1800 10 ml h UF goal Off 10 10 000 10 ml Cont heparin adm Off 0 1 25 0 1 ml h Dialysate 600 4800 50 ml h Citrate blood citrate dose 2 0 6 0 0 1 mmol l Calcium filtrate calcium dose 0 3 0 0 1 mmol l Temperature Off 35 39 0 5 C postCVVHDF with ci...

Page 206: ...gulation can have various consequences including a considerable reduction of the mutual activation of the various vitamin K dependent modified coagulation factors The binding of these coagulation factors to activated cell membranes requires calcium which is bound to their GLA domain and is therefore only possible with sufficiently high levels of ionised calcium Limits of citrate anticoagulation Ci...

Page 207: ...t exceed 20 The substituate flow can for example be selected as 1 6 of the blood flow 16 7 ml min 1000 ml h with a blood flow of 100 ml min With regard to the values set on the display this corresponds to a ratio of 10 1 If the haemoconcentration at the filter outlet exceeds 20 due to the required calcium flow and a clinically required ultrafiltration the substituate flow can be reduced so that th...

Page 208: ... can be collected on the venous side if the patient does not have an arterial access This must be considered in the interpretation of the acid base values Here a collection site separate from the extracorporeal blood circuit is recommended Alternatively the blood sample can be taken slowly from the sampling site red of the access line while the blood pump is running In case of recirculation in the...

Page 209: ...her magnesium concentration in the dialysate used or an additional infusion of magnesium may be indicated Sodium Hypernatraemia has been reported for some variants of citrate anticoagulation This was caused by excessive sodium concentrations in the citrate solution used in combination with a failure to adjust the sodium concentration in the HF solution dialysate Therefore the Na concentration of C...

Page 210: ... determining the ionised calcium in the extracorporeal blood circuit Lowering values to below 0 35 mmol l of ionised calcium in the extracorporeal blood circuit downstream of the filter is associated with only a minor risk of coagulation in the extracorporeal blood circuit For Ci Ca postCVVHDF lowering values slightly more has the benefit of inhibiting a premature increase in the concentration of ...

Page 211: ...cium infusion i e the sum of calcium infused with the calcium solution and the calcium in the substitution fluid in relation to the filtrate flow Unlike with Ci Ca CVVHD very small values for the calcium dose cannot be set for Ci Ca postCVVHDF since it is essential that calcium is infused with the substitution fluid In particular a calcium dose of 0 0 mmol l can never be set for Ci Ca postCVVHDF T...

Page 212: ...calcemia if the calcium dose is increased repeatedly within short intervals High calcium dose possible citrate accumulation If the calcium dose necessary for stabilising the systemic ionised calcium is higher than 2 1 mmol l this might be indicative of a citrate accumulation The device alerts the operator to this fact when setting the respective calcium doses and suggests a measurement of the tota...

Page 213: ...citrate infusion and the removal of buffer bases as an effect of the dialysis against the adapted dialysate In practice the processes are balanced so that the systemic acid base status of the patient is maintained within the required range The Ci Ca postCVVHDF treatment is based on the Ci Ca CVVHD In Ci Ca postCVVHDF a calcium containing bicarbonate buffered haemofiltration solution is also infuse...

Page 214: ...hich is achievable in practice is taken into consideration For Ci Ca postCVVHDF almost the same applies as for Ci Ca CVVHD However the additional infusion of the bicarbonate buffered substitution fluid has a stabilising effect on the resulting acid base status For an effect on the acid base status the ratio of blood to dialysate flow in Ci Ca postCVVHDF must therefore be changed to a larger extent...

Page 215: ...ed calcium by an appropriate calcium substitution the shift in the concentration ratio of total calcium to systemic ionised calcium is shown by an increased total calcium This increase is relative to the citrate accumulation corresponding to the calcium citrate complexes circulating in the blood An increase of the concentration ratio of total calcium to systemic ionised calcium above 2 5 is cited ...

Page 216: ... mmol l in principle The recommended calcium solution is one with approx 100 mmol l Higher calcium concentrations lead to lower calcium flows and can increase the risk of local clot formation due to the poorer quality of intermixing that occurs at the calcium infusion site The citrate and calcium solutions must be suitable for infusion Note The solutions used for the treatment must be selected suc...

Page 217: ... Citrate solution HF solution dialysate Calcium solution Ci Ca CVVHD 4 Na3citrate corresponding to 136 mmol l citrate 1 0 litre bag Ci Ca dialysate K2 Ci Ca dialysate K4 per 5 litre bag CaCl2 solution in the appropriate concentration 50 to 500 mmol l calcium ions preferably approx 100 mmol l Ci Ca postCVVHDF 4 Na3citrate corresponding to 136 mmol l citrate 1 0 litre bag Ci Ca dialysate K2 Ci Ca di...

Page 218: ...Chapter 7 Functional description 7 30 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 219: ...g term operation Identified by the symbol Indication of the max operating time and the max delivery volume Warning The device has been approved for use with specific consumables and accessories If the responsible organisation wishes to use consumables and accessories other than those specified here it must first check whether they are suitable by obtaining relevant information from the manufacture...

Page 220: ...ultiFiltrate cassette with Ultraflux AV 1000 S and substituate dialysate system multiFiltrate kit 7 HV CVVH 1000 503 818 1 multiFiltrate cassette with Ultraflux AV 1000 S and Pre Post CVVH substituate set multiFiltrate kit CVVHD EMiC 2 F00001173 multiFiltrate cassette with Ultraflux EMiC 2 dialyser and dialysate system multiFiltrate kit Ci Ca CVVHD 1000 503 901 1 Ci Ca multiFiltrate cassette with ...

Page 221: ...scription Ultraflux AV paed 500 823 1 Ultraflux haemofilter steam sterilised 0 2 m2 surface Fresenius Polysulfone membrane blood fill volume 18 ml Luer Lock dialysate and filtrate connectors Ultraflux AV 400 S 500 734 1 Ultraflux haemofilter steam sterilised 0 75 m2 surface Fresenius Polysulfone membrane blood fill volume 52 ml Ultraflux AV 600 S 500 736 1 Ultraflux haemofilter steam sterilised 1 ...

Page 222: ...nius Plasmasulfone membrane plasmaFlux PSu 2S 500 481 1 Plasma filter filled with sterile water steam sterilised 0 6 m2 surface blood fill volume 70 ml Fresenius Plasmasulfone membrane plasmaFlux P1 dry 500 802 1 Plasma filter delivered dry steam sterilised 0 3 m2 surface blood fill volume 35 ml Fresenius Polysulfone membrane plasmaFlux P2 dry 500 803 1 Plasma filter delivered dry steam sterilised...

Page 223: ...male Luer Lock 1 x male Luer Lock for use of 2 filtrate bags Adapter female Luer Lock 501 480 1 For connection of 2 male Luer Lock connectors Adapter male Luer Lock 501 477 1 For connection of 2 female Luer Lock connectors Collection bag 2000 ml 501 509 1 2000 ml collection bag with female Luer Lock connector Filtrate bag 10 l 502 901 1 Filtrate collection bag with drain cock male Luer Lock connec...

Page 224: ...hout contents M28 494 1 Handle M28 491 1 Dialyser holder 677 792 1 LAN connection cable Cat 5 length 1 m M28 072 1 LAN connection cable Cat 5 length 2 m M28 073 1 LAN connection cable Cat 5 length 3 m M28 074 1 LAN connection cable Cat 5 length 5 m M28 075 1 LAN connection cable Cat 5 length 10 m M28 076 1 LAN connection cable Cat 5 length 15 m M28 077 1 LAN connection cable Cat 5 length 20 m M28 ...

Page 225: ...ith a protective earth conductor connection is required The line cross section and the line lengths to the wall outlet must ensure that the voltage tolerance and the function of the protective devices is always guaranteed Recommended line cross section to the power socket at least 3 x 1 5 mm2 copper core for 220 V 240 V and at least 3 x 2 5 mm2 copper core for voltages of less than 220 V Each elec...

Page 226: ...ent time for the device to adjust to the ambient temperature before start up Qualification requirements of testers The initial system start up must only be performed by the manufacturer s service support organisation or a person authorised by it The initial start up must only be performed by personnel qualified to perform the required procedures correctly based on their education training knowledg...

Page 227: ...re parts catalog The use of additional extension cables or multiway sockets connectors is prohibited Equipotential bonding Using the original accessories connect the equipotential bonding conductor to the rear of the device if this is required by law or for special applications at the place of installation Leakage currents If additional equipment not listed in the Accessories chapter is connected ...

Page 228: ...Chapter 9 Installation 9 4 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 229: ...chine properly before moving Preferably move the device backwards with the two big stationary wheels ahead Warning Risk of tilting when pushing the device or leaning against it If excessive lateral force is exerted it may result in tilting or slipping of the device Note The maximum loading capacity of 12 kg per scale must not be exceeded The weighing cell can also be permanently damaged by a short...

Page 230: ...be relocated inside a building or ward In other words The functional test is complete The tubing systems cassette have been inserted primed and rinsed The treatment parameters have been entered The device is in the Recirculation mode The loads on the device must not exceed the following specifications Preferably use the front hooks The device can be disconnected from the power supply by pulling ou...

Page 231: ...ation that is not within the immediate vicinity of its current location then the relocation goes beyond the scope of the previous section In this case the full initial start up procedure must be performed again at the destination When transporting the haemodialysis system in a vehicle always protect it with the appropriate packing materials and place it either vertically or horizontally 10 3 Stora...

Page 232: ...apter 6 on page 6 1 The responsible organisation must inform the facility in charge of dismantling and disposing of the device of the following before the disposal measures begin There is a potential risk that the device is contaminated when it is returned Therefore the appropriate precautionary measures must be taken when dismantling the product such as wearing personal protective equipment 10 4 ...

Page 233: ...owing initial start up after delivery from the factory All additional maintenance procedures are required before the end of the 24th month following the last maintenance procedure performed Qualification requirements of testers The checks must only be performed by the manufacturer s service support organisation or a person authorised by it The checks may only be performed by personnel qualified to...

Page 234: ...Chapter 11 Technical Safety Checks maintenance procedures 11 2 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 235: ...nsions and weight Dimensions Height 172 cm 140 cm without IV poles and scales trays Width with Ci Ca module 75 cm 65 cm without IV poles Width without Ci Ca module 65 cm 57 cm without IV pole Depth 65 cm Weight Weight with options approx 100 kg Safe working load 55 kg Maximum weight approx 155 kg IV pole load bearing capacity Total IV pole load bearing capacity max 6 kg Hook load bearing capacity ...

Page 236: ...Legend 1 Type identification 2 Serial number 3 Maximum total weight 4 Manufacturer and year of manufacture 5 Identification of electric and electronic devices 6 CE marking 7 Equipment code EC Equipment Code 8 Protection rating IP 21 2 Protection against touch and foreign bodies with a diameter of at least 12 5 mm 1 Protection against ingress of liquids Drip proof 12 2 2 Voltage label Legend 1 Conn...

Page 237: ...treatment mode the applied part comprises the extracorporeal blood circuit the dialysate substituate and plasma circuits and all components with a permanent conductive connection to these circuits Degree of protection against electric shock 220 V 230 V 240 V 60 Hz type BF applies 100 V 110 V 115 V 120 V 127 V 60 Hz type CF applies 100 V 110 V 115 V 120 V 127 V 220 V 230 V 240 V 50 Hz type CF appli...

Page 238: ...A 240 V AC 50 60 Hz 2 7 A Always go by the line voltage frequency and operating current information specified on the identification label attached to the device itself Power supply internal 24 V 18 V battery backed derived from this voltage 5 V 0 2 V 12 V 0 3 V 12 V 0 3 V 24 V 1 V 2 V Power switch Main power switch all pole simultaneous disconnection Battery Lead acid battery maintenance free 18 V...

Page 239: ...stance must be kept between radiated interference sources in the vicinity of running medical electrical devices For further information on Guidance and manufacturer s declaration on EMC refer to the Service Manual Warning Patient hazard due to device malfunction Using accessories or lines other than those specified in the Instructions for Use can lead to increased emitted interference or reduced i...

Page 240: ...s Radiated interference source examples One device radiated interference source may use more than one RF transmission technology GSM Global System for Mobile Communications 3 3 m Cell phone smartphone tablet computer UMTS Universal Mobile Telecommunications System LTE Long Term Evolution DECT Digital Enhanced Cordless Telecommunications 1 2 m Cordless phone WLAN Wireless Local Area Network 0 7 m N...

Page 241: ...urrent emissions according to IEC 61000 3 2 Class A Emissions from voltage fluctuations flicker according to IEC 61000 3 3 Compliant Guidance and manufacturer s declaration on electromagnetic interference immunity The multiFiltrate device is designed for operation in an electromagnetic environment as specified below The customer or operator of the multiFiltrate device should ensure that it is oper...

Page 242: ...quency magnetic fields should correspond to the typical values found in the commercial and hospital environment Note UT is the AC voltage before the test level is applied Portable and mobile radio devices should not be any closer to the multiFiltrate device including the lines than the recommended safety distance which is calculated according to the relevant equation for the transmission frequency...

Page 243: ...trate device b Above the frequency range of 150 kHz to 80 MHz the field strength should be lower than 3 V m Recommended safety distances between portable and mobile RF telecommunication devices and the multiFiltrate device The multiFiltrate device is designed for operation in an electromagnetic environment in which RF disturbances are controlled The customer or operator of the multiFiltrate device...

Page 244: ...uipment Furthermore all device configurations must comply with the requirements specified by medical system standards see chapter 16 and appendix I to EN 60601 1 2006 Connecting the device to an IT network that contains components not installed and validated by the manufacturer can introduce unknown risks for patients operators or third parties These risks must be identified analysed evaluated and...

Page 245: ...larm indicator does not influence whether visual and acoustic alarms are generated at the device 12 9 Operating programs Functional test Automatic test for verification of the safety systems Starts automatically every time the device is turned on The functional test is mandatory after turning the device power on not after a power failure Preparation Defined by the optical detector located below th...

Page 246: ...shold smaller than or equal to 0 5 ml blood loss per minute at a haematocrit of 32 at maximum filtrate flow Optical adsorption system red green ratio The response threshold is related to the maximum filtrate flow The initiation of a blood leak alarm also depends on the ultrafiltration rate and the size of the membrane rupture in the filter Flow rates Depending on the treatment mode The delivery ac...

Page 247: ...us the temperature of the solution and the environment There are two alarm threshold values If values temporarily exceed an inflow temperature of 42 C an override period begins without an immediate alarm Once 5 seconds have passed an alarm is triggered and the fluid inflow is stopped which must be acknowledged If values continue to exceed 42 C the alarm is triggered again after 5 seconds Another a...

Page 248: ... senses non opaque fluid 20 mmHg during treatment The optical detector senses opaque fluid 0 mmHg during treatment The optical detector senses opaque fluid 20 mmHg when disconnecting When the upper venous alarm limit is exceeded the venous clamp will not be closed to allow for release of the pressure in the system In the event of a simultaneous air detector alarm the clamp will close TMP Display r...

Page 249: ...0 ml min to 300 ml min or 500 ml min Method ultrasonic transmission Heparin pump Pump type syringe pump Delivery rate 0 1 ml h to 25 ml h Resolution 0 1 ml h Accuracy 5 for a delivery rate of 1 ml h to 25 ml h and a measurement time of 2 hours up to a counterpressure of 1 2 bars calibrated for 30 ml Fresenius heparin syringes With delivery rates 1 0 ml h the tolerance may exceed the specified 5 ac...

Page 250: ...12 12 Materials used Plastics CR neoprene NBR Buna N PA 6 6 polyamide PC Gfn Makrolon PE Hostalen POM Delrin PS polystyrene PVC tube transparent Silicone tube transparent reinforced E HGW 2372 1 epoxy resin laminated plastic Cast resin WEVO PU 127F 30 PUR hard foam BÜFADUR 1011 1151 with flame retardant Metals Al 99 5 AlCuMgPb AlMg3 AlMgSi 0 5 AlMgSi 1 CuBe SF Cu hard oxygen free CuZn Ms 63 St 37 ...

Page 251: ... ICS MODE green Kiroff Fürth Primer Warneckol Super M Primer Warnecke Böhm Schliersee Dilution ZANSI 150024 Warnecke Böhm Schliersee Coating varnish Durotec pur Plus Warnecke Böhm Schliersee Dilution Durotec 550007 Warnecke Böhm Schliersee Hardener Pur Plus hardener 540001 Warnecke Böhm Schliersee Coating varnish 2K structural varnish SW Color Bindlach Hardener 2K hardener 3500 SW Color Bindlach D...

Page 252: ...Chapter 12 Specifications 12 18 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 253: ...fined site in the arterial section between the vascular access and the pump Exchange volume The exchange volume is the fluid volume removed from the blood by filtration which is replaced with substituate at a ratio of 1 1 The respective rate is indicated in ml h or ml min The respective rate is the indicator at which speed the exchange is performed Treatment time The treatment time is the amount o...

Page 254: ...ircuit The extracorporeal circuit is the section of the blood circuit outside the body Filtrate bag The filtrate bag is the collection bag for the filtrate ultrafiltrate Filter life The filter life is the total time during which the blood pump is running Filtration Filtration is the convective flow of solutes e g water across a membrane which occurs in response to a hydrostatic and or osmotic pres...

Page 255: ...ltration volume is the fluid volume removed from the blood by filtration which is required for the patient to lose weight The removal rate is indicated in ml h Venous section The venous section is the section of the extracorporeal circuit from the dialyser outlet port to the patient Venous return pressure The venous return pressure is the pressure at a defined site in the venous section e g in the...

Page 256: ...otection rating IP 21 2 Protection against touch and foreign bodies with a diameter of at least 12 5 mm 1 Protection against ingress of liquids Drip proof Protection against ingress of liquids Drip proof IP X1 Degree of protection against electric shock Type BF Degree of protection against electric shock Type CF Degree of protection against electric shock Defibrillator protected applied part type ...

Page 257: ...Medical Device Directive Notified body TÜV PRODUCT SERVICE 0123 Identification of electrical and electronic devices Alarm output Serial interface RS 232 Transmitter Manufacturer and year of manufacture Manufacturer Serial number Maximum total weight Follow Instructions for Use Warning Risk of tilting when pushing the device or leaning against it General warning sign Warning Excessive weight load o...

Page 258: ...ion Consult accompanying documents general danger Do not re use Use by Batch code Date of manufacture Quantity Catalog number Temperature limitation Pump segment diameter Sterile Sterilised using ethylene oxide Sterile Sterilised using irradiation Sterile Sterilised using steam Max service life and max delivery quantity 2 LOT REF 30 C 5 C STERILE EO STERILE R STERILE ...

Page 259: ...3 Definitions Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 13 7 13 5 Certificates The local service support organisation can provide the currently applicable version of the EC certificates on request ...

Page 260: ...Chapter 13 Definitions 13 8 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 261: ...t is started Ci Ca completion During the treatment by deselecting citrate anticoagulation from the Treatment menu Deselect Ci Ca anticoagulation When the optical detector senses non opaque fluid during reinfusion end of treatment Removing the Ci Ca tube segments After reinfusion end of treatment has been completed and the patient has been disconnected the Ci Ca tube pump segments can be removed Th...

Page 262: ...rm will be emitted which will be repeated every 2 minutes HF bag change consequence balancing off calcium pump also stops see Balancing off consequence calcium pump also stops on page 14 2 Syringe change consequence balancing off calcium pump also stops see Balancing off consequence calcium pump also stops on page 14 2 Ci Ca bag change consequence balancing off calcium pump also stops see Balancin...

Page 263: ...ID 14 2 2 1 Previous treatment continuing Warning Data uploaded to a patient data management system must not be used as a basis for diagnosis and or therapy related decisions Note The length of the network cable used should be as short as possible to reduce potential interference The Cat 5 LAN connection cables listed in the following are designed to connect the multiFiltrate to a network hub or s...

Page 264: ...ta has been entered yet the fields are empty Use the rotary selector to select Enter patient case ID OK to confirm and press OK Check the currently used patient ID and case ID If no data has been entered yet the fields are empty Use the rotary selector to select Patient ID or Case ID and press OK in order to change the patient case ID or To confirm the patient case ID use the rotary selector to ch...

Page 265: ...s Use the arrow keys up down to switch from upper to lower case letters and vice versa Use the arrow keys left right to change the position of the cursor in the entry window After entering the data use the rotary selector to select Accept ID OK to confirm and press OK After entering and checking the patient ID and or the case ID use the rotary selector to select Patient case ID correct OK to confi...

Page 266: ...Chapter 14 Options 14 6 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

Page 267: ...e used for the purpose of external alerts staff call Warning Before being applied the treatment parameters which the device receives via the network or the PatientCard 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 for the purpose of external alerts staff call Warning There are special...

Page 268: ...he accompanying documentation contains special information and notes supplies license conditions and or provides the source code of such free software Fresenius Medical Care meets these requirements by providing the copyright notices remarks and license texts contained in section C below Please note that if such information is printed in two languages the English version has priority Content A Hae...

Page 269: ... refer to http www gnu org copyleft gpl html For LGPL please refer to http www gnu org copyleft lesser html B Note required according to Medical Device Legislation This medical device has been certified in conjunction with the Linux operating system software version 2 4 18 Any modification to the software contained in this medical device including the operating system software may result in the me...

Page 270: ...se pieces of it in new free programs and that you know you can do these things To protect your rights we need to make restrictions that forbid anyone to deny you these rights or to ask you to surrender the rights These restrictions translate to certain responsibilities for you if you distribute copies of the software or if you modify it For example if you distribute copies of such a program whethe...

Page 271: ...ole or in part contains or is derived from the Program or any part thereof to be licensed as a whole at no charge to all third parties under the terms of this License c If the modified program normally reads commands interactively when run you must cause it when started running for such interactive use in the most ordinary way to print or display an announcement including an appropriate copyright ...

Page 272: ...ive works These actions are prohibited by law if you do not accept this License Therefore by modifying or distributing the Program or any work based on the Program you indicate your acceptance of this License to do so and all its terms and conditions for copying distributing or modifying the Program or works based on it 6 Each time you redistribute the Program or any work based on the Program the ...

Page 273: ...se of software generally NO WARRANTY 11 BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE THERE IS NO WARRANTY FOR THE PROGRAM TO THE EXTENT PERMITTED BY APPLICABLE LAW EXCEPT WHEN OTHERWISE STATED IN WRITING THE COPYRIGHT HOLDERS AND OR OTHER PARTIES PROVIDE THE PROGRAM AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILI...

Page 274: ...bruary 1999 Copyright C 1991 1999 Free Software Foundation Inc 51 Franklin Street Fifth Floor Boston MA 02110 1301 USA Everyone is permitted to copy and distribute verbatim copies of this license document but changing it is not allowed This is the first released version of the Lesser GPL It also counts as the successor of the GNU Library Public License version 2 hence the version number 2 1 Preamb...

Page 275: ... programs When a program is linked with a library whether statically or using a shared library the combination of the two is legally speaking a combined work a derivative of the original library The ordinary General Public License therefore permits such linking only if the entire combination fits its criteria of freedom The Lesser General Public License permits more lax criteria for linking other ...

Page 276: ...anty keep intact all the notices that refer to this License and to the absence of any warranty and distribute a copy of this License along with the Library You may charge a fee for the physical act of transferring a copy and you may at your option offer warranty protection in exchange for a fee 2 You may modify your copy or copies of the Library or any portion of it thus forming a work based on th...

Page 277: ...to work with the Library by being compiled or linked with it is called a work that uses the Library Such a work in isolation is not a derivative work of the Library and therefore falls outside the scope of this License However linking a work that uses the Library with the Library creates an executable that is a derivative of the Library because it contains portions of the Library rather than a wor...

Page 278: ...his requirement contradicts the license restrictions of other proprietary libraries that do not normally accompany the operating system Such a contradiction means you cannot use both them and the Library together in an executable that you distribute 7 You may place library facilities that are a work based on the Library side by side in a single library together with other library facilities not co...

Page 279: ...opyrighted interfaces the original copyright holder who places the Library under this License may add an explicit geographical distribution limitation excluding those countries so that distribution is permitted only in or among countries not thus excluded In such case this License incorporates the limitation as if written in the body of this License 13 The Free Software Foundation may publish revi...

Page 280: ... was put into circulation i e when the system was acquired Only the usual copying and transfer costs will be charged If you want us to send this CD to you please inform us accordingly by e mail telefax or mail under the address given in the Instructions for Use Please do not forget to specify the system type and the system number III Mozilla Public License version 1 1 1 Copyright notice The follow...

Page 281: ...stantial portions of the Software The Software is provided as is without warranty of any kind express or implied including but not limited to the warranties of merchantability fitness for a particular purpose and non infringement In no event shall the Daniel Veillard be liable for any claim damage or other liability whether in an action of contract tort or otherwise arising from out of or in conne...

Page 282: ...Chapter 15 Appendix 15 16 Fresenius Medical Care multiFiltrate IFU EN UK 15A 2015 ...

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