Fresenius Medical Care multiFiltrate Instructions For Use Manual
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Fresenius Medical Care multiFiltrate Instructions For Use Manual

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multiFiltrate
Instructions for Use
Software version: 5.3
Edition: 15A-2015
Part no.: M56 963 1

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Summary of Contents for Fresenius Medical Care multiFiltrate

  • Page 1 Instructions for Use Software version: 5.3 Edition: 15A-2015 Part no.: M56 963 1...

  • Page 3: Table Of Contents

    2.12.5 Warnings relating to consumables and accessories ..............2-15 2.13 Addresses ..........................2-16 Design Views of the device ........................3-1 3.1.1 Front view ............................ 3-1 3.1.2 Rear view............................. 3-2 Controls and indicators ......................3-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 4 3.2.1 Monitor............................3-4 3.2.2 Heparin pump..........................3-5 3.2.3 Extracorporeal blood circuit module .................... 3-6 3.2.4 multiFiltrate with Ci-Ca module (option)..................3-7 3.2.4.1 Ci-Ca module front view ....................3-8 3.2.4.2 Ci-Ca module rear view ....................3-8 User interface..........................3-9 Operation Application principles ....................... 4-1 Basic operation philosophy......................
  • Page 5 Priming the tubing system ..................4-55 4.7.6.2 Rinsing the tubing system / entering treatment parameters........4-56 4.7.6.3 UF rinse........................4-57 4.7.6.4 Recirculation / waiting for patient ................4-57 4.7.6.5 Connecting the patient ....................4-58 4.7.7 Treatment ..........................4-59 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 6 Recirculation / waiting for patient ................4-85 4.9.5.5 Connecting the patient ....................4-86 4.9.6 Treatment ..........................4-87 4.9.6.1 Treatment main screen ....................4-87 4.9.6.2 Treatment menu ......................4-88 4.9.6.3 Treatment parameters ....................4-88 4.9.7 End of treatment ........................4-89 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 7 Default treatment settings......................4-120 4.12.2 Setting the date / time......................4-120 4.13 Interrupting the treatment..................... 4-121 4.13.1 Disconnecting the patient / interrupting the treatment ............. 4-122 4.13.2 Connecting the patient / continuing the treatment ..............4-123 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 8 Haemoperfusion (HP) ........................ 7-15 Anticoagulation........................7-16 7.3.1 Systemic anticoagulation ......................7-16 7.3.2 Regional anticoagulation with citrate ..................7-17 7.3.2.1 General information on citrate anticoagulation ............7-17 7.3.2.2 Adequate anticoagulation in the extracorporeal blood circuit ........7-22 viii Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 9 Information for the responsible organisation ................10-4 10.4.2 Information for recycling and waste disposal facilities............... 10-4 11 Technical Safety Checks / maintenance procedures 11.1 Important information on the Technical Safety Checks / maintenance procedures..11-1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 10 Requirements ..........................14-3 14.2.2 Treatment with patient / case ID ....................14-3 14.2.2.1 Previous treatment, continuing ................... 14-3 14.2.2.2 Entering the patient / case ID in UF rinse..............14-4 15 Appendix 15.1 Network............................. 15-1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 11 15.2 Instructions on the use of "free software"................15-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 13 Display brightness 4-119 treatments 7-9 Disposable syringes 8-4 Connection options 12-10 Disposables 8-5 Connector strip 3-2 Backfiltration 4-1 Documentation 9-2 11-1 Consumables 8-1 Bag change 12-12 Continuous venovenous Balance data 4-110 4-111 4-112 haemodiafiltration 7-7 4-113 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 14 Manufacturer's declaration on Preparation 12-11 Haemofilter / plasma filter 8-3 EMC 12-7 Pre-Post CVVH flow diagram 7-5 Haemofiltration 13-2 Materials 12-16 Pressure graphs 4-110 Haemofiltration solutions 8-4 Membrane plasma separation Pressure transducer 12-14 Haemoperfusion 4-92 4-64 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 15 Vascular access 7-2 Substituate 13-3 Venous alarm limit 4-4 4-115 Substituate / dialysate / filtrate bag change 4-107 Venous bubble catcher level, raising and lowering 4-11 Surface cleaning / surface disinfection 6-1 Venous pressure 12-14 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 16 Chapter 1: Index Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 17 2013 – The page identification, for example, 1-3 refers to chapter 1, page 3. Organisation of the To facilitate the use of documents from Fresenius Medical Care, the chapters organisation of the chapters has been standardised in all manuals.

  • Page 18: Significance Of Warnings

    Advises the operator that failure to observe this information can result in the following: – Damage to the device. – Required functions will not be executed at all or will be executed incorrectly. Significance of tips Information providing useful tips for easy handling. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 19: Brief Description

    (e.g., delivery rates, fill volumes). – Operation in suitable rooms in professional health care facilities. Normative and local regulations must be observed. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 20: Treatment Modes And Fields Of Application

    – Patients with whom the haemofilter rapidly and repeatedly becomes clogged when different anticoagulation methods are used. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 21: Paediatric Cvvh And Cvvhd Treatment Modes

    CRRT solution can have a more pronounced effect. Regional anticoagulation – Metabolic acid-base disorders (acidosis, alkalosis) with citrate – Systemic hypocalcemia or hypercalcemia – Hypomagnesaemia – Hypernatraemia – Side effects caused by a disordered citrate metabolism Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 22: Contraindications

    Note Any treatment in connection with citrate anticoagulation may only be performed in intensive care units or under similarly close medical monitoring. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 23: Interaction With Other Systems

    2.6.11 Target group The device may only be installed, operated, and used by individuals with the appropriate training, knowledge, and experience and for whom proof of instruction can be shown. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 24: To Be Observed When Working On The Device

    Instructions for Use. The device may only be operated by individuals certificated to have been instructed on the proper operation and handling of the device. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 25: Operator Responsibility

    – The actual values displayed must be compared with the prescribed target values. The device may only be operated under the operating conditions specified by the manufacturer. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 26: Disclaimer Of Liability

    2.12.2 Warnings related to therapy Warning Risk of cross-contamination if tubing systems without hydrophobic filters are used  Only use tubing systems with hydrophobic filters in the pressure lines. 2-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 27 If you need to move any part of the tubing system out of position, make sure the correct layout of the entire tubing system is restored before continuing treatment, paying special attention to the correct placement of the positioners. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 2-11...
  • Page 28 Warning Risk of injury due to damaged tubing systems Risk of infection  Install the tubing systems in such a way that they cannot be damaged by objects with sharp edges or pets. 2-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 29: Warnings Relating To The System

    Danger in case of excessive load (respect the maximum load) If the load on the IV pole is too high, the device may tilt. Ensure that the maximum allowed load on the IV pole of 6 kg is not exceeded. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 2-13...

  • Page 30: Electrical Warnings

    B or BF applied part of the device (multiFiltrate). Central venous catheter positioned in the atrium...

  • Page 31: Warnings Relating To Consumables And Accessories

    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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 2-15...

  • Page 32: Addresses

    Chapter 2: Important information 2.13 Addresses Manufacturer Fresenius Medical Care AG & Co. KGaA 61346 Bad Homburg Germany Phone: +49 6172 609-0 www.fmc-ag.com International Fresenius Medical Care service support Deutschland GmbH Service Support International Hafenstrasse 9 97424 Schweinfurt Germany Phone: +49 9721 678-333 (hotline)

  • Page 33: Design

    Chapter 3: Design Design Views of the device 3.1.1 Front view Legend IV pole Scale 1 Scale 2 Monitor Extracorporeal blood circuit module Scales 3 and 4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 34: Rear View

    Chapter 3: Design 3.1.2 Rear view Legend Tube holders Heparin pump Identification label Connector strip Pocket for Instructions for Use Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 35 Chapter 3: Design 3.1.2.1 Connector strip Legend Power switch Line voltage selector Power supply connection Equipotential bonding 10-Base-T Ethernet socket (LAN) (option) RS 232, SUB-D, 9-pin Alarm output Loudspeaker Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 36: Controls And Indicators

    3.2.1 Monitor Legend Screen Tube holders Rotary selector and [OK] key [ESC] key [Mute] key [STOP] key [START/RESET] key [On/Off] key Status indicator Green LED (operation) Yellow LED (warning / preparation) Red LED (alarm) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 37: Heparin Pump

    The  key moves the slide carriage up as long as the key is pressed. The  key moves the slide carriage automatically down. Pressing this key again will stop the slide carriage. Syringe holder Slide carriage Grip handle Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 38: Extracorporeal Blood Circuit Module

    (see chapter 8.1.1 on page 8-2) Filtrate pressure port (yellow) Air detector Blood pump (red dot) Pressure port before filter (white) Arterial pressure port (red) Venous pressure port (blue) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 39: Multifiltrate With Ci-Ca Module (Option)

    Chapter 3: Design 3.2.4 multiFiltrate with Ci-Ca module (option) Legend Second IV pole with connector in the IV pole bearing Ci-Ca module Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 40: Ci-Ca Module Front View

    Citrate insertion switch Calcium drop counter Calcium pump Calcium insertion switch 3.2.4.2 Ci-Ca module rear view Legend Holder for IV pole Securing lever with pressure roll Voltage supply and signal connection to the multiFiltrate Earthing contact Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 41: User Interface

    Notes (white), warnings (yellow), alarms (red), and pressure graphs Parameter fields Confirmation field Screen identification number Menu bar Shows the available menus. The currently selected menu is displayed with black characters and green background. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 42 Chapter 3: Design 3-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 43: Operation

    – The different pressure conditions on the dialysate and the blood side. – The viscosity of the blood. Warning Aseptic techniques Use aseptic techniques for all blood-side connections and all connections in the area where sterile solutions are to be used. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 44 Ensure that the maximum allowed load on the IV pole of 6 kg is not exceeded. Warning Tubing systems and multiFiltrate kits must be replaced no later than the service life date indicated by the manufacturer. The usable life is specified on the packaging of the tubing systems.
  • Page 45 If you need to move any part of the tubing system out of position, make sure the correct layout of the entire tubing system is restored before continuing treatment, paying special attention to the correct placement of the positioners. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 46 Warning Citrate and calcium solutions The citrate and calcium solutions must be at room temperature before they can be used. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 47: Basic Operation Philosophy

    Pressing the [ESC] key exits the current menu field and activates the menu bar. The selected menu has a green background. Menus that can be selected are shown with white characters on a blue background. Menus that cannot be selected are shown in grey. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 48: Treatment Main Screen

    This screen is displayed during the treatment. If another menu function is selected and entered by pressing the [ESC] key whilst a treatment is in progress, pressing the [ESC] key twice will return you to the main screen. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 49: Entering Treatment Parameters

    While changing the value, the actual value will still be displayed in black. The new target value is shown in white below the actual value. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 50 After the new value has been stored by the system, it will be displayed in black. To enter all other parameters, proceed as described above. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 51: Basic Operation Steps

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

  • Page 52: Resetting The Alarm Limits In Alarm-Free Condition

    Resetting the alarm limits in alarm-free condition  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 on page 5-4) 4-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 53: Raising And Lowering The Venous Bubble Catcher Level

    The bolus anticoagulation 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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-11...

  • Page 54: Making The Device Ready For Operation

    (dimmed). If the device is switched on via the "On / Off" key, the green LED goes out and the yellow LED is illuminated. At the end of the functional test, an audible alarm sounds and the red LED is illuminated and then changes back to yellow. 4-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 55 After turning the device off, wait for approximately 10 seconds before turning it on again.  Connect the device to the power supply.  Connect the equipotential bonding connector to the rear of the multiFiltrate device.  Press the power switch on the rear of the device.

  • Page 56: Starting The Functional Test

    Starting the functional test Note If the multiFiltrate device is provided with a Ci-Ca module, this module must also pass the functional test after power-on, irrespective of the treatment mode to be selected. If the 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.

  • Page 57: Selecting The Anticoagulation Method

    Note The following screen will not appear if: – The Ci-Ca module is not attached. – Communication between the Ci-Ca module and the multiFiltrate device cannot be established. Contact service support. The decision whether the treatment is to be performed with or without citrate anticoagulation can already be made during the functional test.

  • Page 58: Selecting The Treatment Mode

     Use the rotary selector to select the required treatment mode and press [OK]. The paediatric treatment modes have to be activated by the technician in the service program. Paed. CVVH Paed. CVVHD 4-16 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 59: Crrt Treatments

     Insert the cassette system according to the instructions.  Turn the rotary selector clockwise until the next screen displays.  Continue with "Inserting the heparin syringe" (see chapter 4.5.4 on page 4-21) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-17...

  • Page 60: Inserting The Arterial Blood Line System

     Turn the rotary selector clockwise until the next screen displays. 4.5.2.3 Inserting the venous blood line system  Insert the venous blood line system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. 4-18 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 61: Inserting The Filtrate Line System

    The settings for the tubing system may only be changed by technical service support. With the CVVHD and CVVH (not Pre-Post) treatment modes, both scales can be loaded with solutions if 2 x HF female adapters are used on 4 x HF male adapters. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-19...

  • Page 62: Inserting The Dialysate Or Sub Predilution Tubing System (Except For Cvvh)

    Inserting the substituate or sub postdilution tubing system (except for CVVHD)  Insert the substituate or sub postdilution tubing system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. 4-20 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 63: Inserting The Heparin Syringe

    Blood clots (coagula) can cause the air bubble detector to fail. Note Ensure that the filtrate bag hangs freely and does not touch any other objects. Do not insert the filtrate tube too tightly between the blood leak detector and the filtrate bag. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-21...

  • Page 64: Preparation

     Use the rotary selector to select Start priming? [OK] to confirm! and press [OK]. Heparin can be added to the NaCl solution used for priming and rinsing via the Bolus menu field. 4-22 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 65: Rinsing The Tubing System / Entering Treatment Parameters

     Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-23...

  • Page 66: Uf Rinse

     Stop recirculation by pressing the [STOP] key. Press the [STOP] key for approx. 3 seconds.  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. 4-24 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 67: Connecting The Patient

     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: Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-25...

  • Page 68: Treatment

    The current flow rates (dialysate, substituate, sub predilution, sub postdilution, blood flow, ultrafiltration) Heparin The status bar shows: The treatment mode The progression of the treatment time The balance Continuous anticoagulation on / off 4-26 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 69: Treatment Menu

     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 automatically return to the treatment main screen. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-27...

  • Page 70: Change Of Procedure (Except For Cvvhd And Cvvh)

    Change of procedure to CVVH  Use the rotary selector to select Dialysate and set it to Off. 4.5.8.2 Change of procedure to CVVHD Note "Sub. bolus 100 ml" is not possible in CVVHD. 4-28 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 71: Change Of Procedure Back To Cvvhdf

    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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-29...

  • Page 72: End Of Treatment

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.5.11 on page 4-32). 4-30 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 73  Use the rotary selector to select Terminate reinfusion and press [OK]. The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-31...

  • Page 74: Disconnecting The Patient And Removing The Tubing System

    [OK] to confirm! Confirm with [OK]. 4.5.12 Treatment history Indication of the treatment parameters for the respective treatment mode for the entire treatment.  Press the [I/O] key to turn the device off. 4-32 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 75: Crrt Treatments With Citrate Anticoagulation

    System parameters / Select Ci-Ca data menu. 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]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-33...

  • Page 76: Inserting The Cassette System

    The following requirements must be fulfilled before inserting the Ci-Ca pump segments to be able to perform automatic priming: – The clamps (white and green) are moved to the connectors. – The clamps (white and green) are closed. 4-34 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 77: Inserting Further Tubing Systems

    The settings for the tubing system may only be changed by technical service support. 4.6.3.1 Inserting the dialysate tubing system Warning Ci-Ca CVVHD and Ci-Ca postCVVHDF treatments may only be performed if calcium-free dialysate is used. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-35...

  • Page 78: Inserting The Substituate Tubing System (Except For Cvvhd Ci-Ca)

    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 clockwise until the next screen displays. 4-36 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 79: Inserting The Heparin Syringe

    Blood clots (coagula) can cause the air bubble detector to fail. Note Ensure that the filtrate bag hangs freely and does not touch any other objects. Do not insert the filtrate tube too tightly between the blood leak detector and the filtrate bag. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-37...

  • Page 80: Preparation

    15 mm. If this fails, manually readjust the level.  Use the rotary selector to select Ci-Ca clamps opened? Ci-Ca drip chambers filled? [OK] to confirm! and press [OK]. 4-38 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 81: Priming The Ci-Ca Lines

     Once the Ci-Ca lines are primed while being free from air, use the rotary selector to select Ci-Ca lines primed and free from air? [OK] to confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-39...

  • Page 82: Priming The Tubing System

    Please ensure that the ratios of blood flow to dialysate flow / substituate flow are properly set. Note Please set the treatment parameters (citrate dose, calcium dose, blood flow, dialysate flow) as described in chapter 7. 4-40 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 83  Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-41...

  • Page 84: Uf Rinse

     Stop recirculation by pressing the [STOP] key. Press the [STOP] key for approx. 3 seconds.  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. 4-42 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 85: Connecting The Patient

    10 ml/min to 100 ml/min (default 100 ml/min) The citrate pump will deliver at the corresponding rate. It will stop if the optical detector senses opaque fluid or, for safety reasons, after 10 minutes at the latest. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-43...

  • Page 86: Treatment

    Warning If the measured post-filter calcium value or systemic calcium value varies significantly, please consult a physician. Observe the instructions on taking a sample (see chapter 7.3.2 on page 7-17). 4-44 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 87: Treatment Main Screen

    Citrate / blood dose and citrate flow Calcium / filtrate dose and calcium flow Heparin The status bar shows: The treatment mode The progression of the treatment time The balance Continuous anticoagulation on / off Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-45...

  • Page 88: Treatment Menu

     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 automatically return to the treatment main screen. 4-46 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 89: End Of Treatment

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.6.9 on page 4-48). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-47...

  • Page 90: Disconnecting The Patient And Removing The Tubing System

    It is forbidden to remove the Ci-Ca lines manually before the patient is disconnected. Warning Consumables must be discarded after the treatment in compliance with the regulations for the disposal of potentially contaminated materials. 4-48 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 91  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 history? [OK] to confirm! Confirm with [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-49...

  • Page 92: Treatment History

    Chapter 4: Operation 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. 4-50 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 93: Paediatric Crrt Treatments

    Make the device ready for operation (see chapter 4.4 on page 4-12). 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.

  • Page 94: Inserting The Venous Blood Line System

     Turn the rotary selector clockwise until the next screen displays. 4.7.3 Inserting further tubing systems Depending on the selected treatment mode, the tubing system for dialysate or substituate has to be inserted. 4-52 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 95: Inserting The Dialysate Tubing System (Except For Cvvh)

    4.7.3.2 Inserting the substituate tubing system (except for CVVHD)  Insert the substituate tubing system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-53...

  • Page 96: Inserting The Heparin Syringe

    Blood clots (coagula) can cause the air bubble detector to fail. Note Ensure that the filtrate bag hangs freely and does not touch any other objects. Do not insert the filtrate tube too tightly between the blood leak detector and the filtrate bag. 4-54 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 97: Preparation

     Use the rotary selector to select Start priming? [OK] to confirm! and press [OK]. Heparin can be added to the NaCl solution used for priming and rinsing via the Bolus menu field. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-55...

  • Page 98: Rinsing The Tubing System / Entering Treatment Parameters

     Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. 4-56 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 99: Uf Rinse

     Stop recirculation by pressing the [STOP] key. Press the [STOP] key for approx. 3 seconds.  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-57...

  • Page 100: Connecting The Patient

     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: Paediatric 10 ml/min to 50 ml/min (default 50 ml/min) 4-58 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 101: Treatment

    The current flow rates (dialysate, substituate, sub predilution, sub postdilution, blood flow, ultrafiltration) Heparin The status bar shows: The treatment mode The progression of the treatment time The balance Continuous anticoagulation on / off Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-59...

  • Page 102: Treatment Menu

     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 automatically return to the treatment main screen. 4-60 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 103: End Of Treatment

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.7.9 on page 4-63). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-61...
  • Page 104  Use the rotary selector to select Terminate reinfusion and press [OK]. The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid. 4-62 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 105: Disconnecting The Patient And Removing The Tubing System

    Confirm with [OK]. 4.7.10 Treatment history Indication of the treatment parameters for the entire treatment. The menu fields shown depend on the selected treatment mode.  Press the [I/O] key to turn the device off. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-63...

  • Page 106: Membrane Plasma Separation (Mps)

     Insert the cassette system according to the instructions.  Turn the rotary selector clockwise until the next screen displays.  Continue with "Inserting the heparin syringe" (see chapter 4.8.4 on page 4-67) 4-64 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 107: Inserting The Arterial Blood Line System

     Turn the rotary selector clockwise until the next screen displays. 4.8.2.3 Inserting the venous blood line system  Insert the venous blood line system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-65...

  • Page 108: Inserting The Filtrate Line System

     Turn the rotary selector clockwise until the next screen displays. 4.8.3 Inserting the plasma line system  Insert the plasma line system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. 4-66 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 109: Inserting The Heparin Syringe

    Blood clots (coagula) can cause the air bubble detector to fail. Note Ensure that the filtrate bag hangs freely and does not touch any other objects. Do not insert the filtrate tube too tightly between the blood leak detector and the filtrate bag. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-67...

  • Page 110: Preparation

     Use the rotary selector to select Start priming? [OK] to confirm! and press [OK]. Heparin can be added to the NaCl solution used for priming and rinsing via the Bolus menu field. 4-68 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 111: Rinsing The Tubing System / Entering Treatment Parameters

     Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-69...

  • Page 112: Uf Rinse

     Stop recirculation by pressing the [STOP] key. Press the [STOP] key for approx. 3 seconds.  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. 4-70 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 113: 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 filling of plasma is in progress. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-71...

  • Page 114: Connecting The Patient

     Disconnect the venous patient line from the NaCl solution and connect it to the venous vascular access.  Use the rotary selector to select Start treatment? [OK] to confirm! and press [OK]. 4-72 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 115: Treatment

    Detailed description (see chapter 4.11 on page 4-104). Deactivate the blood leak detector (see chapter 5.13 on page 5-16). After a timeout, the display will automatically return to the treatment main screen. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-73...

  • Page 116: Treatment Parameters

    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]. 4-74 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 117 [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]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-75...

  • Page 118: End Of Treatment

    [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. 4-76 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 119: Terminating The Treatment

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.8.9 on page 4-79). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-77...
  • Page 120  Use the rotary selector to select Terminate reinfusion and press [OK]. The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid. 4-78 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 121: Disconnecting The Patient And Removing The Tubing System

     Use the rotary selector to select View treatment history? [OK] to confirm! Confirm with [OK]. 4.8.10 Treatment history Indication of the treatment parameters for the entire treatment.  Press the [I/O] key to turn the device off. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-79...

  • Page 122: Slow Continuous Ultrafiltration (Scuf)

    Slow continuous ultrafiltration (SCUF) Prepare the device ready for operation (see chapter 4.4 on page 4-12). Note The multiFiltrate paed CRRT / SCUF set tubing system (part no. 501 775 1) has to be used for the SCUF treatment mode. 4.9.1 Starting conditions Note Each treatment mode has its individual starting conditions.

  • Page 123: Inserting The Venous Blood Line System

     Turn the rotary selector clockwise until the next screen displays. 4.9.2.3 Inserting the filtrate line system  Insert the filtrate line system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-81...
  • Page 124 Blood clots (coagula) can cause the air bubble detector to fail. Note Ensure that the filtrate bag hangs freely and does not touch any other objects. Do not insert the filtrate tube too tightly between the blood leak detector and the filtrate bag. 4-82 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 125: Complete Tubing Arrangement

     Use the rotary selector to select Start priming? [OK] to confirm! and press [OK]. Heparin can be added to the NaCl solution used for priming and rinsing via the Bolus menu field. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-83...
  • Page 126  Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. 4-84 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 127: Uf Rinse

     Stop recirculation by pressing the [STOP] key. Press the [STOP] key for approx. 3 seconds.  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-85...
  • Page 128  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: Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min) 4-86 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 129: Treatment

    The current pressures (arterial, venous, TMP) The current flow rates (blood flow, ultrafiltration) Heparin The status bar shows: The treatment mode The progression of the treatment time The balance Continuous anticoagulation on / off Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-87...

  • Page 130: Treatment Parameters

     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. 4-88 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 131: End Of Treatment

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.9.8 on page 4-91). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-89...
  • Page 132  Use the rotary selector to select Terminate reinfusion and press [OK].  The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid. 4-90 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 133  Use the rotary selector to select View treatment history? [OK] to confirm! Confirm with [OK]. 4.9.9 Treatment history Indication of the treatment parameters for the entire treatment.  Press the [I/O] key to turn the device off. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-91...
  • Page 134  Insert the cassette system according to the instructions.  Turn the rotary selector clockwise until the next screen displays.  Continue with "Inserting the heparin syringe" (see chapter 4.10.3 on page 4-94) 4-92 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 135  Turn the rotary selector clockwise until the next screen displays. 4.10.2.3 Inserting the venous blood line system  Insert the venous blood line system according to the instructions.  Turn the rotary selector clockwise until the next screen displays. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-93...
  • Page 136 4.10.4 Complete tubing arrangement 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. 4-94 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 137  Use the rotary selector to select Start priming? [OK] to confirm! and press [OK]. Heparin can be added to the NaCl solution used for priming and rinsing via the Bolus menu field. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-95...
  • Page 138  Use the rotary selector to enter the required parameters and press [OK]. Set all treatment parameters as described above.  Use the rotary selector to select All treatment parameters entered? [OK] to confirm! and press [OK]. 4-96 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 139 NaCl solution. If using an NaCl solution with one connector:  Connect the venous patient line to the arterial patient line using the recirculator.  Continue recirculation by pressing the [START/RESET] key. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-97...
  • Page 140  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: Cassette / adults 10 ml/min to 100 ml/min (default 100 ml/min) 4-98 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 141 The current pressures (arterial, venous, pF) The current flow rates (blood flow) Heparin The status bar shows: The treatment mode The progression of the treatment time Continuous anticoagulation on / off Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-99...
  • Page 142  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. 4-100 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 143: Starting Reinfusion

    [OK] to confirm! and press [OK]. When selecting Disconnect without blood return, the program will go directly to "Disconnecting the patient" without reinfusion after a safety prompt (see chapter 4.10.8 on page 4-103). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-101...
  • Page 144  Use the rotary selector to select Terminate reinfusion and press [OK]. The treatment will be terminated automatically if the reinfusion volume is 0 ml and the optical detector senses non-opaque fluid. 4-102 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 145: Disconnecting The Patient And Removing The Tubing System

     Use the rotary selector to select View treatment history? [OK] to confirm! Confirm with [OK]. 4.10.9 Treatment history Indication of the treatment parameters for the entire treatment. Press the [I/O] key to turn the device off. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-103...

  • Page 146: Treatment Menu

    / performed if a calcium-containing HF solution / dialysate is used. Warning After deselecting citrate anticoagulation, the Ci-Ca lines must not be removed from the pumps before the patient has been completely disconnected. 4-104 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 147: Selecting Ci-Ca Anticoagulation

    When starting the treatment, define the post-filter calcium value. If the ionised calcium has not decreased at this point, it is absolutely necessary that the tubing system and the solutions used are checked. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-105...
  • Page 148 [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. 4-106 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 149: Substituate / Dialysate / Filtrate Bag Change

    [OK]. 4.11.4 Ci-Ca bag change Note The Ci-Ca bag change menu can be accessed: – Manually by selecting the Ci-Ca bag change menu. – Automatically after a bag change notification. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-107...
  • Page 150 Select Cancel bag change to return to the Treatment menu.  Use the rotary selector to select Citrate bag change completed or Ca bag change completed from the menu field and press [OK]. 4-108 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 151: Syringe Change

    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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-109...

  • Page 152: Pressure Graphs

    The balance is the amount of fluid that is removed from and added to the patient during the treatment. During the CRRT treatments and SCUF, all volumes (substituate, citrate, calcium, heparin) which are added continuously are completely removed by the filtrate pump. 4-110 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 153: Balance Data During The Treatment

    "zero". The treatment time and the filter life will not be reset. – Balance data development – Balance previous treatment Display: – Treatment time – Filter Life Further values displayed: – Dependent on the treatment mode Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-111...

  • Page 154: Balance Data Development

     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 the period of time entered is calculated automatically and displayed. 4-112 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 155: Total Balance After The Treatment

    Treatment menu 4.11.7.5 Total balance after the treatment Indication of the treatment parameters for the entire treatment. 4.11.7.6 Balance since reset The balance data since the last balance data reset will be displayed. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-113...

  • Page 156: Alarm Limits Menu

    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. 4-114 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 157: Changing The Venous Width Of The Alarm Limits Window

     Use the rotary selector to enter the required window width and press [OK]. 4.11.8.3 Exiting the Alarm limits menu  Use the rotary selector to select Exit Alarm limits menu? [OK] to confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-115...

  • Page 158: Events

     Use the rotary selector to select Page and press [OK] to confirm. Ten events per page will be displayed when you turn the rotary selector. 4-116 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 159: Sub. Bolus 100 Ml

    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 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-117...
  • Page 160 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. 4-118 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 161: System Parameters

    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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-119...

  • Page 162: Default Treatment Settings

    The parameters that were changed are not activated until the device is brought back into operation with the [I/O] key. 4.12.2 Setting the date / time Set the current date and time. 4-120 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 163: Interrupting The Treatment

    – The stopped anticoagulation process must be restarted. Warning Always observe aseptic procedures when connecting and disconnecting the patient and perform the process with due care to avoid any loss of blood. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-121...

  • Page 164: Disconnecting The Patient / Interrupting The Treatment

    When the optical detector senses non-opaque fluid, disconnect the venous patient line from the patient and connect it to the NaCl solution.  Press the [START/RESET] key. Balancing stops automatically. Ci-Ca pumps stop automatically. 4-122 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 165: Connecting The Patient / Continuing The Treatment

    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 necessary, set blood flow and heparin administration. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 4-123...
  • Page 166 Chapter 4: Operation Interrupting the treatment 4-124 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 167: Alarm Processing

    Wrong dosage of anticoagulation medium Blood leak alarms Loss of blood into filtrate / plasma Isolated citrate dosage with Citrate accumulation / balancing switched off disruption of acid-base status Low temperature warning Hypothermia Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 168: Alarm Schemes

    The operating status indicator is yellow and the signal emits an audible warning. Internally, the alarms and warnings are given different priorities (described in the following section). The system also offers the option of using isolated audible signals to inform the operator. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 169: New Alarm Scheme

    Since critical alarm situations can cause the machine to be placed in Safe Mode (halting treatment), alarms with high priority are only triggered in exceptional cases, where a potential hazardous condition persists even following alarm response. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 170: Monitoring Function Suppression

    Full sensitivity at max. blood flow is achieved with patient weights upwards of 45 kg. If return pressure is negative (e.g., when deploying central venous catheters) then the risk of an air infusion is present, even downstream of the air detector. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 171 Audible alarm Silencing the audible alarm will always suppress an alarm for a duration suppression / of 2 minutes. Any new alarm that occurs will activate the silenced mute audible alarm. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 172: Alarm System Response

    The Mute key allows the operator 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. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 173: Messages

    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 correct the messages. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 174: Note Box (White)

    Balance is off. By selecting the green question mark with the rotary selector and pressing [OK], the operator will obtain support in correcting the cause of the problem. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 175: Alarm Box

    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 the cause of the problem. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 176: Messages During The Functional Test

     Repeat the functional test by pressing the [START/RESET] key. Note If the functional test was not passed even after having been repeated, and if the problem cannot be corrected, call service support. 5-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 177: Handling Alarm Limits In The Event Of An 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 pumps will start (depending on the treatment mode). Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 5-11...

  • Page 178: Ratio Of Uf Rate To Bp Rate

    20% of the BP rate. Substituate + ultrafiltration = UF rate 2000 ml/h + 200 ml/h = 2200 ml/h = 36.6 ml/min At a BP rate of 150 ml/min, this equals a UFR / BPR of 24.4%. 5-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 179 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 changing the parameters. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 5-13...

  • Page 180: Ratio Of Calcium Flow To Filtrate Flow

    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...

  • Page 181: Ratio Of Citrate Flow To Bp Rate

    The citrate flow rate is calculated by the system depending on the set citrate dose, the set blood flow, and the concentration of the citrate solution used (set in the multiFiltrate Setup menu), and is limited by the control range of the citrate pump.

  • Page 182: Overriding The Blood Leak Detector

    It is important to pay attention to additional darkening due to a blood leak in the filtrate bag, particularly when using a permanent override for plasma separation. 5-16 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 183 [Yes], the blood leak detector no longer monitors for haemolysis or blood loss (Blood leak detector deactivated!). Monitoring can be reactivated at any time in the Treatment menu. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 5-17...

  • Page 184: Power Failure (Mains Failure)

    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). 5-18 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 185: Manual Reinfusion

     When the blood has been returned manually, close the clamps on the tubing system and remove the venous patient line.  Dismantle the tubing system manually. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 5-19...
  • Page 186 Chapter 5: Alarm processing 5-20 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 187: Cleaning / Disinfection

    Active substance base: 45% ethanol Type of disinfection: quick-acting disinfectant for wipe disinfection combined with Freka-Wipes disposable cloths ClearSurf Wipes Ready to use wipes Active substance base: cationic surfactants Type of disinfection: wipe disinfection Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 188 Chapter 6: Cleaning / disinfection Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 189: Functional Description

    During a Ci-Ca treatment, a significant amount of calcium is removed from the patient's blood. For this reason, a calcium substituate is infused into the venous return line by the integrated calcium pump. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 190: Description Of Treatments

    20%. If this limit is exceeded, this will be displayed on the device. If the haemoconcentration is too high, it can be reduced by increasing the blood flow or reducing the substitution in postdilution. It is also possible to select another CRRT treatment as an alternative. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 191 Blood flow ml/min Ultrafiltration Off / 10 1800 ml/h UF goal Off / 50 10,000 Cont. heparin adm. Off / 0.1 ml/h Substituate 4800 ml/h Temperature Off / 35 °C Fig.: CVVH flow diagram Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 192 1200 ml/h UF goal Off / 50 10,000 Cont. heparin adm. Off / 0.1 ml/h Sub predilution Off / 600 4800 ml/h Sub postdilution Off / 600 4800 ml/h Temperature Off / 35 °C Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 193 Air detector Venous clamp Filtrate pump Blood leak detector Filtrate Scales 3 and 4 Predilution Postdilution Check valve Heater 1 Substituate pump 1 Scale 2 Substituate Heater 2 Substituate pump 2 Scale 1 Substituate Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 194 Min. Max. Resolution Unit Blood flow ml/min Ultrafiltration Off / 10 1800 ml/h UF goal Off / 50 10,000 Cont. heparin adm. Off / 0.1 ml/h Dialysate 4800 ml/h Temperature Off / 35 °C Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 195 Combination of the basic These three basic treatments can be combined in pairs: treatments CVVHDF Pre CVVH + CVVHD => Pre CVVHDF Post CVVH + CVVHD => Post CVVHDF Pre CVVH + Post CVVH => Pre-Post CVVH Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 196 (UFR / BPR) is not affected by this. Fig.: CVVHDF flow diagram Legend Blood pump Haemofilter Air detector Venous clamp Filtrate pump Blood leak detector Filtrate Scales 3 and 4 Predilution Postdilution Check valve Heater Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 197 It was revealed that the filter operating lives are significantly longer in CVVHD than in Pre-Post CVVH, even if the limitation of the filtration fraction to 20% in Pre-Post CVVH was observed. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 198: Paediatric Crrt Treatments

    2 l/h for a typical adult with a body weight of 70 kg. The value 1.73 m² is the general value for the body surface of a typical adult. 7-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 199: Membrane Plasma Separation (Mps)

    Replacement solution As the plasma removed contains colloid osmotically active proteins such as albumin, replacement solutions containing iso-oncotic colloids are typically used. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-11...
  • Page 200 MPS treatments will not be performed until the following day at the earliest. Treatment parameters Min. Max. Resolution Unit Blood flow ml/min Plasma Off / 10 ml/min Temperature Off / 35 °C Cont. heparin adm. Off / 0.1 ml/h 7-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 201 Fig.: MPS flow diagram Legend Blood pump Haemofilter Air detector Venous clamp Filtrate pump Blood leak detector Filtrate Scales 3 and 4 Check valve Heater 1 Heater 1 Substituate pump Scale 2 Plasma Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-13...

  • Page 202: Slow Continuous Ultrafiltration (Scuf)

    Off / 50 10,000 Cont. heparin adm. Off / 0.1 ml/h Fig.: SCUF flow diagram Legend Blood pump Haemofilter Air detector Venous clamp Filtrate pump Blood leak detector Filtrate Scales 3 and 4 7-14 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 203: Haemoperfusion (Hp)

    Treatment parameters Available settings Min. Max. Resolution Unit Blood flow ml/min Cont. heparin adm. Off / 0.1 ml/h Fig.: Schematic of a haemoperfusion treatment (HP) Legend Blood pump Adsorber cartridge Air detector Venous clamp Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-15...

  • Page 204: Anticoagulation

    This pump can also be used to administer a bolus when required. An infusion line for anticoagulants is included in the tubing system. Fig.: Schematic of systemic anticoagulation Legend Blood pump Haemofilter Air detector Venous clamp Heparin pump 7-16 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 205: Regional Anticoagulation With Citrate

    Off / 10 14,400 Cont. heparin adm. Off / 0.1 ml/h Dialysate 4800 ml/h Substituate 2400 ml/h Citrate / blood (citrate dose) mmol/l Calcium / filtrate (calcium dose) mmol/l Temperature Off / 35 °C Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-17...
  • Page 206 This is possibly explained by the fact that activated thrombin, as opposed to prothrombin (thrombinogen, factor II), no longer has a GLA domain, which explains why the mechanism discussed above cannot be effective with thrombin. 7-18 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 207 When performing a Ci-Ca treatment, this is checked downstream of the filter. Note It is absolutely necessary to ensure that the two measurements of the ionised calcium are not mistaken for each other. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-19...
  • Page 208 In case of recirculation in the area of the catheter, blood which has just been returned will enter into the aspirated blood, along with some citrate. This addition of citrate leads to incorrect measurement values for the systemic ionised calcium. 7-20 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 209 HF solution / dialysate. Therefore, the Na concentration of Ci-Ca dialysates K2 and Ci-Ca dialysates K4 has been adjusted to 133 mmol/l. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-21...

  • Page 210: Adequate Anticoagulation In The Extracorporeal Blood Circuit

    All kits for Ci-Ca treatments permit a representative check after 5 minutes even in case of a low blood flow of 80 ml/min. 7-22 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 211: Control Of Systemic Ionised Calcium

    In Ci-Ca postCVVHDF, the calcium concentration of the substitution fluid infused in postdilution is also considered in the calculation. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-23...
  • Page 212 A clogged membrane has severely restricted functionality and must be replaced (restart treatment following replacement of the multiFiltrate kit). 7-24 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 213: Controlling The Systemic Acid-Base Status

    One positive extra effect of the increased citrate dose is that it inhibits a premature increase in the concentration of ionised calcium following infusion of the calcium-containing substitution fluid at the postdilution stage. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-25...
  • Page 214 The full effect can, however, only be assessed after approximately one day. This is particularly important to bear in mind if several equivalent changes are made within short intervals as these may cause an excessive response. 7-26 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 215: Citrate Accumulation

    After completion of the treatment, the accumulated calcium-citrate after citrate complexes are metabolised by the patient. This may result in alkalosis anticoagulation and hypercalcaemia. If clinically indicated, these risks can be reduced by continuing the CRRT treatment without citrate anticoagulation. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-27...

  • Page 216: Solutions For Citrate Anticoagulation

    Depending on the citrate and calcium solutions used locally, the concentration of the citrate and calcium ions must be stored in mmol/l in the System parameters menu of the multiFiltrate. This is done by technical service personnel. This also applies to the filling volume of the storage containers used.
  • Page 217 (corresponding to Ci-Ca dialysate K4 appropriate concentration 136 mmol/l citrate) per 5 litre bag (50 to 500 mmol/l calcium 1.0 litre bag ions); In addition, a preferably approx. calcium-containing, 100 mmol/l bicarbonate-buffered substitution fluid Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 7-29...
  • Page 218 Chapter 7: Functional description 7-30 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 219: Consumables, Accessories, Additional Equipment

    Disposables Identified by the symbol: Do not re-use Use by date Identified by the symbol: Use by Long-term operation Identified by the symbol: Indication of the max. operating time and the max. delivery volume Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 220: Consumables

    Chapter 8: Consumables, accessories, additional equipment Consumables 8.1.1 multiFiltrate kits The ready-to-use multiFiltrate kits comprise all tubing systems required for the respective therapy. Used in conjunction with this device, these tubing systems constitute a defibrillator-proof applied part. Product Part number Description ®...

  • Page 221: Haemofilter / Plasma Filter

    6 MPS P2 503 895 1 multiFiltrate cassette with plasmaFlux 2S, MPS substituate system, and filtrate bag ® multiFiltrate kit 16 MPS P1 dry F00003316 plasmaFlux P1 dry, with multiFiltrate Midi AV set, MPS substituate, filtrate system, and filtrate bag ®...

  • Page 222: Dialysate And Haemofiltration Solutions

    1.5 l bag 8.1.6 Disposable syringes Product Part number Description Fresenius Medical Care heparin syringe, 503 032 1 30 ml Fresenius Injectomat syringe, 50 ml 900 071 1 Fresenius P syringe, 50 ml 900 076 1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 223: Other Disposables

    Hydrophobic filter for connection to male Luer-Lock Check valve 850 080 1 Male / female Luer-Lock Clamp 284 024 1 For clamping tubes Freka-Flex transfer system 288 901 1 Infusion system with roller clamps and drip chamber Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 224: Accessories

    LAN connection cable Cat. 5; length 20 m M28 078 1 Crossover patch cable Cat. 5; length 3 m M36 433 1 Retrofit kit for power cable; length 5 m M28 169 1 Paediatric dialyser holder M38 420 1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 225: Installation

    (RCD less than 30 mA) for each device or electric circuit. – Overvoltage / lightning protection in the main and emergency power supply networks. – A connecting bolt must be available for an additional equipotential bonding conductor. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 226: Installation / Initial Start-Up Requirements

    Documentation The initial start-up report and further procedural information are described in the Service Manual. Reports are available on request. The completion of the initial start-up must be entered in the Medical Device Register. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 227: Electrical Installation

    Leakage currents If additional equipment not listed in the Accessories chapter is connected to the device, there is a danger that the permitted leakage currents will be exceeded. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 228 Chapter 9: Installation Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 229: Transport / Storage

    Do not use the handles on the upper part of the unit (monitor hood) to lift the system. 10.1 Relocation Moving Since the system is provided with a cart, the device can easily be relocated (by moving it on a level surface) within a building. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 10-1...
  • Page 230 The device indicates a power failure. The audible alarm can be suppressed for 2 minutes by pressing the [Mute] key. The device must be relocated as fast as possible, as battery operation is only possible for a limited time. 10-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 231: Transport

    – Use the power cable to connect the device to the power supply. – Actuate the power switch to turn the device on. – Leave the device on for 10 hours. If the device is not used, repeat this procedure every six months. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 10-3...

  • Page 232: Environmental Compatibility And Disposal

    Batteries and rechargeable batteries must be properly disposed of in accordance with the applicable local regulations. The device includes electronic circuit boards and an LCD screen. More information will be made available to waste disposal facilities on request. 10-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 233: Technical Safety Checks / Maintenance Procedures

    The Technical Safety Checks, the maintenance points, and further procedural information are described in the Service Manual. Reports are available on request. The completion of the Technical Safety Checks must be entered in the Medical Device Register. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 11-1...
  • Page 234 Chapter 11: Technical Safety Checks / maintenance procedures 11-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 235: Specifications

    Weight with options: approx. 100 kg Safe working load: 55 kg Maximum weight: approx. 155 kg IV pole load-bearing Total IV pole load-bearing capacity: max. 6 kg capacity Hook load-bearing capacity: max. 5 kg Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-1...

  • Page 236: Identification Label

    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 Connected load Operating current Degree of protection against electric shock 12-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 237: Identification Label Of The Ci-Ca Module

    Samples of approved tubing systems are listed in chapter 8 (see chapter 8.1.1 on page 8-2). Degree of protection Drip-proof, IP 21 against ingress of liquids Leakage currents According to EN 60601-1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-3...

  • Page 238: Electrical Supply

    +24 V +1 V / –2 V Power switch Main power switch, all-pole, simultaneous disconnection Lead-acid battery (maintenance-free), 18 V / ≥3 Ah Battery Operating time approx. 15 minutes Blood circuit only, without balancing, without heater 12-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 239: Information On Electromagnetic Compatibility

    A device malfunction can be caused by high-frequency electromagnetic waves (radiated interference source).  Observe the minimum required distances for radiated interference sources. For further information on "Guidance and manufacturer's declaration on EMC", refer to the Service Manual. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-5...
  • Page 240 If a source of radiated interference uses a radio frequency technology not specified in the table, the required minimum distance to medical electrical devices can be obtained from the manufacturer. 12-6 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 241: Guidance And Manufacturer's Declaration On Emc

    Guidance and manufacturer's declaration on electromagnetic emissions 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 operated in such an environment. Interference emission Compliance Electromagnetic environment –...
  • Page 242 Note: U 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: Operating Conditions

    To determine the electromagnetic environment with regard to stationary transmitters, consider carrying out a study of the site. If the measured field strength at the site where the multiFiltrate device is used exceeds the aforementioned compliance level, the multiFiltrate should be observed in order to verify that it is working as intended.

  • Page 244: Storage Conditions

    – Updates or upgrades of components and devices in the IT network Note that local laws take priority over the above-mentioned normative requirements. Please address any queries to the local service support organisation. 12-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 245: Operating Programs

    Priming the tubing Automatic priming and deaeration of the tubing systems by pressing a systems key. Priming will stop automatically as soon as the venous bubble catcher is filled. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-11...

  • Page 246: Balancing / Dialysate Circuit And Safety Systems

    < 1% related to the total volume delivered during 24 hours of treatment, circuit in horizontal position and with a maximum inclination of 5°. A deviation of ±100 ml is possible if the total volume delivered is low (typically up to 5000 ml). 12-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 247 50 ml/min, a temperature of 37 °C will be reached. – The donor plasma (FFP) must be warmed to a minimum temperature of 20 °C prior to the treatment. (* = Important performance characteristics according to IEC 60601-1) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-13...

  • Page 248: Extracorporeal Blood Circuit And Safety Systems

    Accuracy: 10 mmHg Alarm window width: 20 mmHg to 200 mmHg, size and position adjustable around actual pressure The pF is calculated using the following formula and then displayed: pF = P – P 12-14 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 249 Delivery accuracy: pressure-dependent, ±10% (above typical pressure range); for delivery rates < 6 ml/h, the deviation can be ±20% Delivery rate: 10 to 600 ml/h (citrate / blood ratio: citrate concentration per litre of delivered blood: 2–6 mmol/l) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-15...

  • Page 250: Materials Used

    Electrical equipment Motors: Copper, cast steel, cast zinc Stepper motors with plastic gear Plug connectors: Copper, tin, plated gold, glass-fiber-reinforced thermoplastic Transformers: Copper, polyester / polyurethane, potting compound (PU 151/20), UP resin, iron core 12-16 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 251 Pur-Plus hardener 540001, Warnecke & Böhm, Schliersee Coating varnish: 2K structural varnish, SW-Color, Bindlach Hardener: 2K hardener 3500, SW-Color, Bindlach Dilution: 2K dilution, SW-Color, Bindlach Packaging Corrugated cardboard, collapsible cardboard box Polyethylene, cellular rubber, internal packing Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 12-17...
  • Page 252 Chapter 12: Specifications 12-18 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 253: Terms

    The dose is specified in mmol per litre of filtrate (filtrate flow). Calcium flow The calcium flow is the volume of calcium solution supplied to the patient’s blood per time unit. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 13-1...
  • Page 254 Convection Convection describes the transport of solutes together with the solvent (drag effect, e.g., haemofiltration). ME device Medical electrical device. Non-ME device Non-medical electrical device. Postdilution Adding substituate downstream of the haemofilter. 13-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 255: Abbreviations

    Alternating current Blood pump Calcium Citrate CRRT Continuous renal replacement therapy CVVH Continuous venovenous haemofiltration CVVHD Continuous venovenous haemodialysis CVVHDF Continuous venovenous haemodiafiltration Direct current Haemofiltration Haemoperfusion Pre-Post CVVH High-volume continuous venovenous haemofiltration Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 13-3...

  • Page 256: Symbols

    Degree of protection against electric shock: Defibrillator-protected applied part, type BF Degree of protection against electric shock: Defibrillator-protected applied part, type CF Alternating current Equipotential bonding connection Risk of tilting when inclined by more than 5° 13-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 257 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 (observe the maximum load) Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 13-5...

  • Page 258: Consumables Symbols

    Catalog number Temperature limitation +30°C +5°C Pump segment diameter Sterile. Sterilised using ethylene oxide STERILE EO Sterile. Sterilised using irradiation STERILE R Sterile. Sterilised using steam STERILE Max. service life and max. delivery quantity 13-6 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 259: Certificates

    Chapter 13: Definitions 13.5 Certificates The local service support organisation can provide the currently applicable version of the EC certificates on request. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 13-7...
  • Page 260 Chapter 13: Definitions 13-8 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 261: Options

    Ci-Ca module has been completed successfully. – Is completed as soon as the optical detector of the multiFiltrate system senses opaque fluid. Citrate anticoagulation –...
  • Page 262 If citrate bag change is selected  An alarm will be emitted if bag change is not completed within 2 minutes of selecting the citrate bag change. This alarm will be repeated every 2 minutes. 14-2 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 263: Multidatalink (Option) And Patient / Case Id

    The Cat. 5 LAN connection cables listed in the following are designed to connect the multiFiltrate to a network hub or switch. Direct connection of the acute dialysis device to a PC requires a Cat. 5 crossover patch cable.

  • Page 264: Entering The Patient / Case Id In Uf Rinse

    Case ID and press [OK] in order to change the patient / case ID. To confirm the patient / case ID, use the rotary selector to choose Patient/case ID correct? [OK] to confirm! and press [OK]. 14-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 265 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 confirm! and press [OK]. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 14-5...
  • Page 266 Chapter 14: Options 14-6 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 267: Appendix

    Note For reasons of data protection, the operator is responsible for the safekeeping of the PatientCard. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-1...
  • Page 268 / 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.

  • Page 269: Note Required According To Medical Device Legislation

    For that reason, section B contains an appropriate note. In such a case, Fresenius Medical Care will stop any further technical support for the device involved. In addition, such modifications and / or manipulations may result in the voiding of warranty claims against Fresenius Medical Care or other vendors of the haemodialysis system if a claim has arisen or might arise in respect thereto.
  • Page 270 The precise terms and conditions for copying, distribution and modification follow. GNU GENERAL PUBLIC LICENSE TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION 15-4 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 271 Sections 1 and 2 above provided that you also do one of the following: a) Accompany it with the complete corresponding machine-readable source code, which must be distributed under the terms of Sections 1 and 2 above on a medium customarily used for software interchange; or, Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-5...
  • Page 272 This section is intended to make thoroughly clear what is believed to be a consequence of the rest of this License. 15-6 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 273: Gnu Lesser General Public License, Version

    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. II. GNU Lesser General Public License, version 2.1 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-7...
  • Page 274 15-8 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 275 "work based on the library" and a "work that uses the library". The former contains code derived from the library, whereas the latter must be combined with the library in order to run. GNU LESSER GENERAL PUBLIC LICENSE TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-9...
  • Page 276 Library, the distribution of the whole must be on the terms of this License, whose permissions for other licensees extend to the entire whole, and thus to each and every part regardless of who wrote it. 15-10 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 277 Library among them, as well as a reference directing the user to the copy of this License. Also, you must do one of these things: Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-11...
  • Page 278 Library subject to these terms and conditions. You may not impose any further restrictions on the recipients' exercise of the rights granted herein. You are not responsible for enforcing compliance by third parties with this License. 15-12 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...
  • Page 279 IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE LIBRARY IS WITH YOU. SHOULD THE LIBRARY PROVE DEFECTIVE, YOU ASSUME THE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-13...

  • Page 280: Mozilla Public License, Version

    IV. Veillard License 1. Copyright notice The following copyright notice applies to the libXML library: Copyright © 1998-2002 Daniel Veillard. All Rights Reserved. 2. Note In addition, the following license conditions apply: 15-14 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

  • Page 281: Catharon License (Libft2Lib)

    Software without prior written authorisation from him. V. Catharon License (Libft2lib) Part of this software is based on programmings made by Catharon Productions, Inc. Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015 15-15...
  • Page 282 Chapter 15: Appendix 15-16 Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015...

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