B. Braun H.E.L.P. Plasmat Futura Instructions For Use Manual
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B. Braun H.E.L.P. Plasmat Futura Instructions For Use Manual

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H.E.L.P. Plasmat® Futura
Instructions for Use SW 3.0x
H.eparin induced
E.xtracorporeal
L.DL
P.recipitation

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Summary of Contents for B. Braun H.E.L.P. Plasmat Futura

  • Page 1 H.E.L.P. Plasmat® Futura Instructions for Use SW 3.0x H.eparin induced E.xtracorporeal L.DL P.recipitation...
  • Page 2 CE-marking according to guideline 93/42/EWG Technical alterations reserved B. Braun Avitum AG 34209 Melsungen Germany Art. No. 38910323ENCA / Rev. 3.03.00 / February 2015 www.bbraun.com...

  • Page 3: Table Of Contents

    H.E.L.P. Plasmat® Futura CONTENTS Contents 1 Safe Handling............3 ..........3 BOUT THESE NSTRUCTIONS FOR 1.1.1 Validity ........................3 1.1.2 Target Group for the Instructions for Use............3 1.1.3 Warnings, Notices and Symbols in These Instructions for Use....3 1.1.4 Abbreviations......................4 INTENDED USE AND INDICATION..........
  • Page 4 H.E.L.P. Plasmat® Futura CONTENTS 4 Priming and Rinsing..........3 AUTOMATIC PRIMING AND RINSING........3 PARAMETER SETTING.............. 10 4.2.1 Parameter Setting in the <Main Parameter> Screen .........10 4.2.2 Parameter Setting in the <Parameter Overview> Screen ......14 4.2.3 Parameter Setting in the <Flow Scheme> Screen........18 4.2.4 Additional Functions ....................19 5 Therapy..............3...
  • Page 5 H.E.L.P. Plasmat® Futura CONTENTS 8.4.2 List of Warnings.....................31 PROBLEM CORRECTION ............38 8.5.1 Balance Reset ......................38 8.5.2 Deaeration of the Heparin Adsorber..............40 8.5.3 Changing the Solution Bags ................40 8.5.4 Changing the Plasma Filter ................42 8.5.5 Changing the H.E.L.P. Precipitate Filter ............43 8.5.6 Changing the H.E.L.P.
  • Page 6 H.E.L.P. Plasmat® Futura CONTENTS B|BRAUN Rev. 3.03.00 Page 4 of 4 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 7 Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING 1 Safe Handling............3 ..........3 BOUT THESE NSTRUCTIONS FOR 1.1.1 Validity ........................3 1.1.2 Target Group for the Instructions for Use............3 1.1.3 Warnings, Notices and Symbols in These Instructions for Use....3 1.1.4 Abbreviations......................
  • Page 8 Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING B|BRAUN Rev. 3.03.00 Page 2 of 10 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 9: Safe Handling

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING Safe Handling BOUT THESE NSTRUCTIONS FOR These instructions for use form an integral part of the H.E.L.P. Plasmat® Futura machine. They describe the appropriate and safe use of the H.E.L.P. Plasmat® Futura machine at all stages of operation.

  • Page 10: Abbreviations

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING There are three levels of warning notices: Warning term Meaning Imminent danger that can lead to death or serious injury if not DANGER avoided Potentially imminent danger that can lead to death or serious WARNING injury if not avoided Potentially imminent danger that can lead to minor injuries or...

  • Page 11: Intended Use And Indication

    H.E.L.P. Plasmat® Futura machine may only be used in combination with the H.E.L.P. apheresis treatment system from B. Braun Avitum AG. The H.E.L.P. Futura apheresis system is indicated for use in performing low density...

  • Page 12: Side Effects

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING SIDE EFFECTS Occasionally, the occurrence of angina pectoris has been observed. In rare cases, there are  Cardiovascular system: anginal pain, hypertension, hypotension, cardiac arrhythmias, vasovagal reactions  Heart rhythm irregularities and labored breathing caused by the underlying disease ...

  • Page 13: Special Hazards And Precautions

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING SPECIAL HAZARDS AND PRECAUTIONS 1.5.1 Special Patient Conditions A particularly careful benefit-risk evaluation must be carried out before the application of the H.E.L.P. apheresis in the case of patients suffering from C1 esterase inhibitor deficiency or hereditary C3 deficiency.

  • Page 14: Electrical Hazards

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING 1.5.2 Electrical Hazards The H.E.L.P. Plasmat® Futura machine contains life-threatening high electrical voltages. Risk of electric shock and fire.  Always insert mains plug completely into the mains socket.  Always pull/push on the plug not on the mains cord to connect or disconnect the mains plug.

  • Page 15: Information For The Operator

    Chapter 1 H.E.L.P. Plasmat® Futura SAFE HANDLING INFORMATION FOR THE OPERATOR 1.7.1 Training by the Manufacturer Prior to Commissioning The operator may only use the device after the manufacturer has trained the responsible staff based on these instructions for use. 1.7.2 Requirements on the User H.E.L.P.

  • Page 16: Technical Changes

    Instructions for use, enclosed information and maintenance information. 1.7.5 Technical Changes B. Braun Avitum AG reserves the right to change the products in line with further technical developments. DISPOSAL H.E.L.P. Plasmat® Futura machines may be returned to the manufacturer for disposal in accordance with the applicable disposal guidelines.
  • Page 17 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Product Description ..........3 PRINCIPLE ..................3 FUNCTION..................4 MACHINE..................6 2.3.1 Front View ........................6 2.3.2 Upper Module........................7 2.3.3 Central Module ....................... 8 2.3.4 Control Buttons on the Central Module..............9 2.3.5 Rear of the Machine....................10 SYMBOLS ON THE H.E.L.P.
  • Page 18 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION B|BRAUN Rev. 3.03.00 Page 2 of 18 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 19: Product Description

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Product Description PRINCIPLE H.E.L.P. Plasmat® Futura is a plasma therapy unit that, together with the H.E.L.P. apheresis treatment unit, performs H.E.L.P. apheresis therapy. H.E.L.P stands for Heparin-induced Extracorporeal LDL Precipitation. The first step of the procedure is plasma separation. The cellular blood components are directly reinfused to the patient along with the treated plasma.

  • Page 20: Function

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION FUNCTION The blood pump (BP) delivers the blood from the patient’s venous access to the plasma filter. The blood flow is controlled via an arterial pressure transducer (PA). The heparin pump (HP) controls the heparin output for anticoagulation in the arterial line. The blood inlet pressure into the plasma filter is monitored via the prefilter pressure (PBE) of the arterial air chamber.
  • Page 21 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Pumps Sensors Actuators SAK Safety air clamp Blood pump Arterial pressure HAK Heparin adsorber Heparin pump Prefilter pressure clamp PBP Plasma/buffer pump Venous pressure UFP Ultrafiltration pump Plasma pressure Dialysate pump Precipitate filter pressure Dialyzer pressure Dialysate inlet...

  • Page 22: Machine

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION MACHINE 2.3.1 Front View 1) IV-pole (height-adjustable) 2) Upper module 3) Heparin syringe pump 4) Central module 5) Base column 6) Base with brake 7) LCD graphic monitor 8) Plate warmer 9) Front panel with attachment for the H.E.L.P.

  • Page 23: Upper Module

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION 2.3.2 Upper Module 1) LCD graphic colour monitor 2) Connection to valve for automatic level setting in the heparin adsorber air chamber (HCLD) 3) Manual control for level setting in the heparin adsorber air chamber (HCLD) 4) Ultrafiltration pump (UFP) 5) Holder for heparin adsorber air chamber (HCLD) with sensor for level monitoring...

  • Page 24: Central Module

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION 2.3.3 Central Module 1) Plasma pressure (PPL) transducer 2) Venous pressure (PV) transducer 3) Heparin syringe pump (calibrated for 30 ml Omnifix®) 4) Prefilter pressure (PBE) transducer 5) Manual level regulator for venous air chamber 6) Blood pump 7) Manual level regulator for arterial air chamber 8) Arterial pressure (PA) transducer...

  • Page 25: Control Buttons On The Central Module

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Central module 1) Plate warmer 2) Dialysate pump (DP) 3) Brake pushbuttons (apply/release) 4) Dialysate inlet (PDI) pressure transducer 5) Dialysate (DAD) air detector 2.3.4 Control Buttons on the Central Module The level adjustment in the respective chamber is performed with the directly adjacent level adjustment buttons.

  • Page 26: Rear Of The Machine

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION 2.3.5 Rear of the Machine 1) Monitor support 2) IV-pole 3) On/Off switch 4) Handcrank for pumps 5) Handles 6) Mains connection 7) Connection for potential equalization 8) Trend Viewer connector (optional) B|BRAUN Rev.

  • Page 27: Symbols On The H.e.l.p. Plasmat® Futura Machine

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION SYMBOLS ON THE H.E.L.P. PLASMAT® FUTURA MACHINE Observe Instructions for use Observe safety information Application device type B Classification acc. to IEC 60601-1 Electrical ground H.E.L.P. Plasmat® Futura OFF H.E.L.P. Plasmat® Futura ON Alternating current Schematic illustration on safety air detector (SAD) showing the correct way of installing the tube...

  • Page 28: Monitor

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION MONITOR 2.5.1 Monitor Controls The rotary knob moves the cursor on the screen. Display in lines:  Clockwise rotation - the cursor moves from left to right  Counterclockwise rotation - the cursor moves from right to left Display in columns: ...

  • Page 29: Keys For Operating The Blood Pump

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION 2.5.2 Keys for Operating the Blood Pump key and the key lower or raise the delivery rate of the blood pump. If the blood pump stops during an alarm, the red LEDs light. If the blood pump runs, the green LEDs light.
  • Page 30 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Three display variants can be selected for the display area: Main parameter Parameter overview B|BRAUN Rev. 3.03.00 Page 14 of 18 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 31 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION Flow scheme The Help screen can be selected from any screen with the key. B|BRAUN Rev. 3.03.00 Page 15 of 18 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 32 Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION The symbols and abbreviations used for the different pressures in the display areas are explained on the Help screen. To return to the previous screen select <Back Selection> or the screen returns automatically after 30 seconds. B|BRAUN Rev.

  • Page 33: Consumables

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION CONSUMABLES The treatment unit for the H.E.L.P. Plasmat® Futura comprises the following: 2.6.1 H.E.L.P. Futura Set The H.E.L.P. Futura set includes all line systems and filters required for performing H.E.L.P. treatment:  H.E.L.P. Futura kit with Haemoselect L 0.5 plasma filter H.E.L.P.

  • Page 34: Solutions

    Chapter 2 H.E.L.P. Plasmat® Futura PRODUCT DESCRIPTION 2.6.2 Solutions The H.E.L.P. treatment unit includes, in addition to the H.E.L.P. Futura set, all solutions required for performance of a treatment:  2 x 3000 ml H.E.L.P. 0.9 % NaCl sodium chloride solution ...
  • Page 35 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Preparation ............3 SWITCHING ON AND SELFTEST ..........3 3.1.1 Switching on the Machine ..................3 PREPARING THE SOLUTIONS............3 SETTING UP THE BAGS..............5 SETTING UP THE H.E.L.P. FUTURA SET........6 B|BRAUN Rev. 3.03.00 Page 1 of 10 SHARING EXPERTISE Art.
  • Page 36 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION B|BRAUN Rev. 3.03.00 Page 2 of 10 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 37: Preparation

    Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Preparation SWITCHING ON AND SELFTEST 3.1.1 Switching on the Machine Switch on the H.E.L.P. Plasmat® Futura with the On/Off switch on the rear of the machine. Make sure that the machine brake is locked during the treatment. PREPARING THE SOLUTIONS H.E.L.P.
  • Page 38 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Bicarbonate Solution H.E.L.P. BicEL  Remove the outer packing from the bag.  Place the bag on a firm base and press the smaller chamber of the bag with both hands until the seal seam between the two chambers is opened over its full length.

  • Page 39: Setting Up The Bags

    Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION SETTING UP THE BAGS Physiological Saline Solution Bag/Empty Bag Hang the following on the IV-pole of the machine:  one 5-l-empty bag with the connectors upturned,  one prepared 3-l-bag with physiological saline solution as well as ...

  • Page 40: Setting Up The H.e.l.p. Futura Set

    Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION SETTING UP THE H.E.L.P. FUTURA SET Risk to patient due to cross infection!  Use disposables only once. In case of hydrophobic filter breaks:  Replace hydrophobic filter during therapy. WARNING  Replace (or disinfect) internal pressure tubing/filter after therapy. Place the plastic plate of the H.E.L.P.

  • Page 41: B|Braun Rev

    Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Place the two air chambers into the holders as shown. Lock them in place in the holder by turning the black lock. Screw on the four pressure transducers as shown. Check that venous chamber is placed in the holder and screw on the venous pressure transducer.
  • Page 42 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Setting up the arterial line Place the arterial air chamber into the holder. Place the pump segment of the arterial line with the red marking on the left side into the blood pump. Connect the arterial feeder line to the inlet of the plasma filter. Connect the arterial line to the prepared saline bag which is hanging on the IV- pole.
  • Page 43 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION Setting up the dialysate line Insert the heating bag into the plate warmer. Connect the blue inflow line to the dialyzer. Make sure that the Hansen connector is firmly seated. Note: Connect red with red and blue with blue! Place the blue inflow line into the dialysate air detector (DAD).
  • Page 44 Chapter 3 H.E.L.P. Plasmat® Futura PREPARATION B|BRAUN Rev. 3.03.00 Page 10 of 10 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 45 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING 4 Priming and Rinsing ..........3 AUTOMATIC PRIMING AND RINSING.......... 3 PARAMETER SETTING ..............10 4.2.1 Parameter Setting in the <Main Parameter> Screen........10 4.2.2 Parameter Setting in the <Parameter Overview> Screen .......14 4.2.3 Parameter Setting in the <Flow Scheme>...
  • Page 46 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING B|BRAUN Rev. 3.03.00 Page 2 of 20 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 47: Priming And Rinsing

    Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Priming and Rinsing AUTOMATIC PRIMING AND RINSING On the Start screen, the following message is displayed blinking and in red: Press Enter key to start!  If the machine has been prepared as described in the previous chapter, press the key to begin priming and rinsing the system.
  • Page 48 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Status bar 1) Display of blood pump activity Blood pump stands still: One still, four blinking drops. b) Blood pump runs: Increasing and decreasing number of drops. 2) Current time and date 3) Current phase (<Priming>) and current step in the priming phase (<Stand-by [00]>) Menu bar 4) The Main Parameter screen is displayed by default.
  • Page 49 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Blood flow in ml/min Heparin flow in ml/h Heparin bolus in ml Autostop heparin in min Plasma flow in ml/min Rinsing time [Actual/Rest] in min Rinsing volume [Actual/Rest] in ml Plasma volume [Actual/Rest] in ml Balance in g Arterial pressure in mmHg Venous pressure in mmHg...
  • Page 50 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING When <Parameter Overview> is selected in the menu bar, the screen display changes to Parameter Overview. By selecting the <Flow Scheme> menu item in the menu bar, the display changes to the Flow Scheme.
  • Page 51 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Final System Check  Ensure that all connections between the line system and the filters have been made.  Tighten all screw locks as well as the Hansen connectors again.  Make sure that the lines are not kinked. ...
  • Page 52 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Automatic Filling of Blood Side During automatic filling, the arterial line, the plasma filter and the venous line are rinsed and filled by default with 600 ml saline solution.  Start filling the arterial line by pressing the key.
  • Page 53 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Step 11 This step is completed when the minimum rinsing volume of 2400 ml is reached. The following message is displayed in the Warning window <W14: Rinsing completed. For further rinsing set new value ! >. ...

  • Page 54: Parameter Setting

    Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING PARAMETER SETTING Parameter Setting in the <Main Parameter> Screen 4.2.1  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Main Parameter> screen and activate it with the key.
  • Page 55 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING The following parameters can be set in the priming and rinsing phase: Plasma flow rate (%) Rinsing volume (ml) Plasma volume (ml) Balance (g) Heparin flow rate (ml/h) Heparin bolus (ml) Autostop heparin (min) ...
  • Page 56 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING The changing of the following parameters must be confirmed with the key since they are relevant to patient safety:  Plasma flow rate  Plasma volume  Balance  Heparin bolus  Heparin flow rate If a parameter is relevant to patient safety, the currently set value is shown in the Setting window above the setting range.
  • Page 57 PRIMING AND RINSING Risk to patient due to insufficient or too high heparinization.  Use only 30 ml Omnifix® Luer Lock syringes from B. Braun Melsungen AG. Calibration of the heparin syringe pump is ensured only with use of the CAUTION Omnifix©...

  • Page 58: Parameter Setting In The Screen

    Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Parameter Setting in the <Parameter Overview> Screen 4.2.2 key, change to the <Parameter Overview> screen.  Using the rotary knob and the  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Parameter Overview>...
  • Page 59 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING All parameters which can be changed are displayed in red. The currently selected parameter has a gray background. The Setting window displays the allowable range. Using the rotary knob, select the individual parameters. The following parameters can be set in the priming and rinsing phase: ...
  • Page 60 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING  Press the key to activate the parameter to be changed. The field is shown with a red background and white labeling.  Perform the desired change using the rotary knob and confirm it with the key.
  • Page 61 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING In addition to the parameters listed in chapter 4.2.1., the following parameters can be entered: Default setting Range Step size Temperature 39 °C 34 – 40 °C 0.5 °C PA min -150 mmHg -350 –...

  • Page 62: Parameter Setting In The Screen

    Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Parameter Setting in the <Flow Scheme> Screen 4.2.3 key, change to the <Flow Scheme> screen.  Using the rotary knob and the  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Flow Scheme>...

  • Page 63: Additional Functions

    Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING Additional Functions 4.2.4 During Priming and Rinsing in the <Main Parameter>, <Parameter Overview>, and <Flow Scheme> screens, the <Additional Functions> menu item is not active. New Therapy: To cancel the priming and rinsing phase and return to the Start screen, switch off the machine and switch it on again while pressing B|BRAUN Rev.
  • Page 64 Chapter 4 H.E.L.P. Plasmat® Futura PRIMING AND RINSING B|BRAUN Rev. 3.03.00 Page 20 of 20 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 65 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5 Therapy..............3 STARTING THE THERAPY ............3 5.1.1 Starting the Blood Circuit.................... 6 5.1.2 Starting the Plasma Circuit ..................6 TERMINATING THERAPY ............. 7 PARAMETER SETTING ..............9 5.3.1 Parameter Setting in the <Main Parameter> Screen .......... 9 5.3.2 Parameter Setting in the <Parameter Overview>...
  • Page 66 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY B|BRAUN Rev. 3.03.00 Page 2 of 20 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 67: Therapy

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY Therapy Risk to patient due to leakage of acetate buffer bag.  Loss of acetate buffer to the environment leads to a lower efficacy of the therapy.  Loss of acetate buffer to the environment may cause a wrong ultrafiltration. ...
  • Page 68 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY The screen changes to the Therapy screen: Display Area of Therapy Screen: Blood flow in ml/min Heparin flow in ml/h Heparin bolus in ml Autostop heparin in min Plasma flow in ml/min Therapy time [actual/rest] hh:mm Plasma volume [actual/rest] in ml Balance in g B|BRAUN...
  • Page 69 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY Arterial pressure in mmHg Venous pressure in mmHg Prefilter pressure in mmHg Plasma pressure in mmHg.  Select <Start Therapy> in the menu bar. The following message is displayed in the warning window: <W15: Connect buffer, check if seal and clamp are open!>.

  • Page 70: Starting The Blood Circuit

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5.1.1 Starting the Blood Circuit  Disconnect the arterial line from the physiological saline bag on the IV-pole.  Connect the line to the patient access for drawing blood.  The green and red LEDs above the key blink alternately.

  • Page 71: Terminating Therapy

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY The therapy period is timed only while the plasma circuit is running. Risk to patient due to hemolysis because of a high shear stress.  Gradually increase first the blood flow rate to reach the desired target value after 5 minutes.
  • Page 72 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY  Confirm the message <W35: Activate reinfusion?> in the warning window by pressing the key to change to the reinfusion phase. Risk to patient due to blood and/or plasma loss and subsequent blood pressure drop in case of a premature termination of the therapy without reinfusion of the plasma and/or blood volume.

  • Page 73: Parameter Setting

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY PARAMETER SETTING 5.3.1 Parameter Setting in the <Main Parameter> Screen  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Main Parameter> screen and activate it with All parameters which can be changed are displayed in red. The currently selected parameter has a grey background.
  • Page 74 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY The following parameters can be set in therapy phase: Plasma flow rate (%) Plasma volume (ml) Balance (g) Heparin flow rate (ml/h) Heparin bolus (ml) Autostop heparin (min)  Press the key to select the parameter to be changed. The field is shown with a red background and white labeling.

  • Page 75: Parameter Setting In The Screen

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY  The changing of the following parameters must be confirmed with the key since they are relevant to patient safety:  Plasma flow rate  Plasma volume  Balance  Heparin bolus  Heparin flow rate If a parameter is relevant to patient safety, the currently set value is shown in the Setting window above the setting range.
  • Page 76 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY  To set parameters, select the <Parameter Setting> menu item and activate it with All parameters which can be changed are displayed in red. The currently selected parameter has a gray background. The Setting window displays the allowable range. Using the rotary knob, you can select the individual parameters.
  • Page 77 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY  Press to select the parameter to be changed. The field is shown with a red background and white labeling.  Perform the desired change using the rotary knob and confirm it with The changing of the following parameters must be confirmed with since they are relevant to patient safety: ...

  • Page 78: Parameter Setting In The Screen

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5.3.3 Parameter Setting in the <Flow Scheme> Screen key, change to the <Flow Scheme> screen.  Using the rotary knob and the  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Flow Scheme>...

  • Page 79: Additional Functions

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY ADDITIONAL FUNCTIONS 5.4.1 Premature Termination of Therapy  The therapy can be terminated prematurely at any time by selecting <End of Therapy> in the menu bar and activated by pressing the key. If the therapy is prematurely terminated, the warning window with the following message is first displayed <W35: Activate reinfusion?>...

  • Page 80: Premature Termination Of Therapy By Power Failure

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5.4.2 Premature Termination of Therapy by Power Failure In case of power failure longer than 5 minutes only the blood can be returned manually. Use the crank at the rear side of the machine (see 2.3.5). ...

  • Page 81: Additional Functions

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5.4.3 Additional Functions  From the <Main Parameter>, <Parameter Overview> and <Flow Scheme> screens, the <Additional Functions> menu item can be selected and activated by pressing the key. When <Additional Functions> is selected, a submenu with the following selections is opened: ...
  • Page 82 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY Risk to patient due to impact on patient's fluid balance.  Perform the balance reset only when you are sure that the balancing error was triggered by a leakage of the dialysis and/or waste bags and does not concern the patient! WARNING ...

  • Page 83: Heparin Bolus

    Chapter 5 H.E.L.P. Plasmat® Futura THERAPY 5.4.4 Heparin Bolus  To administer a heparin bolus during the therapy, select the <Heparin Bolus> menu item and confirm the input with the key. The warning window is displayed with the following message: <W33: Heparin bolus?>. ...
  • Page 84 Chapter 5 H.E.L.P. Plasmat® Futura THERAPY After heparin administration, the softkey <Stop Therapy> is automatically selected. B|BRAUN Rev. 3.03.00 Page 20 of 20 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 85 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION 6 Reinfusion ..............3 PLASMA REINFUSION ..............3 BLOOD REINFUSION..............6 TERMINATING THE TREATMENT..........7 PARAMETER SETTING ..............9 6.4.1 Parameter Setting in the <Main Parameter> Screen .......... 9 6.4.2 Parameter Setting in the <Parameter Overview> Screen ........11 6.4.3 Parameter Setting in the <Flow Scheme>...
  • Page 86 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION B|BRAUN Rev. 3.03.00 Page 2 of 16 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 87: Reinfusion

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Reinfusion PLASMA REINFUSION After terminating the therapy as described in chapter 5.2, the screen display changes to the Reinfusion screen. Display Area of the Reinfusion Screen Blood flow in ml/min Blood reinfusion time in min Blood reinfusion volume in ml Reinfusion flow in ml/min Reinfusion time in min...
  • Page 88 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Therapy time [actual/rest] in hh:mm Plasma volume [actual/rest] in ml Arterial pressure in mmHg Venous pressure in mmHg After the change to the reinfusion phase, the blood flow is not stopped but set automatically to 30 ml/min. The default setting of the plasma reinfusion volume is 400 ml.
  • Page 89 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION If the precipitate filter pressure rises during the plasma reinfusion because of the high filter saturation, the reinfusion flow should be reduced. Risk to patient due to an excessively fast plasma reinfusion. Some patients experience flushing on the arm used for reinfusion and in the throat area, nausea and/or headaches.

  • Page 90: Blood Reinfusion

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION BLOOD REINFUSION  Stop the blood pump with As long as the blood pump is running the menu <Blood Reinfusion> is not active. The next steps are summarized in a Warning window.  Remove the arterial line from the patient’s arterial access and connect the line to the 500 ml saline bag on the IV-pole.

  • Page 91: Terminating The Treatment

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION TERMINATING THE TREATMENT  Note down all necessary treatment data of the patient.  Select the <Additional Functions> menu item in the menu bar and open the submenu by pressing  Select menu item <New Therapy>. ...
  • Page 92 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION The display returns to the start screen and you can now prepare the machine for another treatment or switch off the machine. B|BRAUN Rev. 3.03.00 Page 8 of 16 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 93: Parameter Setting

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION PARAMETER SETTING Parameter Setting in the <Main Parameter> Screen 6.4.1  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Main Parameter> screen and activate it with All parameters that can be changed are displayed red. The currently selected parameter has a grey background.
  • Page 94 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION The following parameters can be set in the reinfusion phase: Symbol Default Range Step size setting Reinfusion flow 30 ml/min 10 – 50 ml/min 5 ml/min Plasma reinfusion 400 ml 400 – 1000 ml 50 ml volume Blood reinfusion...

  • Page 95: Parameter Setting In The Screen

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Parameter Setting in the <Parameter Overview> Screen 6.4.2 key, change to the <Parameter Overview> screen.  Using the rotary knob and the  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Parameter Overview>...
  • Page 96 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION The following parameters can be set in the reinfusion phase:  Reinfusion flow (ml/min)  Temperature (  PA min (mmHg)  PA max (mmHg)  PV MIN window (mmHg)  PV MAX window (mmHg) ...
  • Page 97 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION  Perform the desired change using the rotary knob and confirm it with the key. The changing of the following parameter must be confirmed with the key since it is relevant to patient safety: ...

  • Page 98: Parameter Setting In The Screen

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Parameter Setting in the <Flow Scheme> Screen 6.4.3 key, change to the <Flow Scheme> screen.  Using the rotary knob and the  To set the parameters, select the <Parameter Setting> menu item with the cursor in the <Flow Scheme>...

  • Page 99: Additional Functions

    Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Additional Functions 6.4.4  At any time during Plasma Reinfusion, you can prematurely terminate the Plasma Reinfusion by selecting <Stop Plasma> in the menu bar and activating it with  To move on to Blood Reinfusion, stop the blood pump with the key.
  • Page 100 Chapter 6 H.E.L.P. Plasmat® Futura REINFUSION Under the <Additional Functions> menu item you can select more functions. The <Back to Therapy> menu item is active only during plasma reinfusion and allows return to therapy. The <New Therapy> menu item is active only during blood reinfusion. It allows for complete termination of the treatment and a return to the Start screen (see chapter 6.3).
  • Page 101 Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS 7 Basic and Default Settings........3 B|BRAUN Rev. 3.03.00 Page 1 of 6 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 102 Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS B|BRAUN Rev. 3.03.00 Page 2 of 6 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 103: Basic And Default Settings

    Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS Basic and Default Settings By simultaneously pressing the key and the key you can go to the Service screen from any screen after the self-test. Technical information is displayed on the left side of the screen (1). The parameters set by default are displayed on the right side of the screen (2).
  • Page 104 Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS  Press the key to activate the parameter to be changed. The field is shown with a red background and white labeling. Perform the desired change using the rotary knob and confirm it with the key.
  • Page 105 Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS Def. Ratio Dialysate/Plasma This parameter sets the ratio of the dialysate flow in relationship to the plasma flow during the therapy and reinfusion. The setting is performed in steps of 1 in the range from 2 to 4.
  • Page 106 Chapter 7 H.E.L.P. Plasmat® Futura BASIC AND DEFAULT SETTINGS  In the menu bar, select <Back Selection>, confirm this input with the key and return to the Start screen. B|BRAUN Rev. 3.03.00 Page 6 of 6 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 107 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Selftests, Alarms and Problem Correction ..3 SELFTEST ..................3 8.1.1 Hardware Selftest ......................3 8.1.2 Selftest Duration and Alarm Code................6 DYNAMIC TESTS AND CONTROLS DURING THERAPY AND REINFUSION ..............12 8.2.1 Blood Leak Detection ....................12 8.2.2...
  • Page 108 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION B|BRAUN Rev. 3.03.00 Page 2 of 46 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 109: Selftests, Alarms And Problem Correction

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Selftests, Alarms and Problem Correction SELFTEST 8.1.1 Hardware Selftest After the machine has been switched on, the system performs a series of hardware selfests. During these tests no disposables must be installed on the machine (solution bags, lines).
  • Page 110 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION The different acoustic signals of the machine are also tested during the selftest. Please make sure the acoustic signals are audible. Make sure that all LEDs are blinking.  During the selftest ensure that the load cell is not equipped with solutions and the pressure transducers are not screwed to the respective connections! ...
  • Page 111 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION  Pumps  Heating  The temperatures of the dialysate measured by the controller and the supervisor, respectively, are compared. Various selftests are performed during the entire therapy in periodic intervals for the safety of the patient.

  • Page 112: Selftest Duration And Alarm Code

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.1.2 Selftest Duration and Alarm Code Test Time Alarm [seconds] Code T0 Tests by the Controller Proper Supervisor operation Periodical life signal is received from Supervisor. Functional states of controller and supervisor are identical Verification whether the controller and the supervisor have the same working state.
  • Page 113 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION T0 Tests by the Supervisor SAD clock test Time control of the SAD is checked. SAD test No or too many SAD tests are executed by the Controller or fluid is detected during test.
  • Page 114 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Controller alarm tone buzzer Selftest The test includes the successive activation of all four alarm tones.  Power failure buzzer  Long alarm tone  The control system initiates the alarm situation of a mains failure for 2 seconds ...
  • Page 115 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Dynamic T1 Tests by the Controller PPF transducer connection test Step 4 Priming While the precipitate filter is filled the position of the PPF transducer is tested for correctness. The connection is correct if: rinsing - (PPF <...
  • Page 116 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Deaeration of the dialysis side and dialysis side tests Step 9 Priming During this phase the dialysis side is tested. The DAD is deaerated and the plate warmer is tested. Afterwards dialysis rinsing pump and ultrafiltration pump are tested.
  • Page 117 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Leakage test of the line system The line system is tested for correct seat and leakage (leakage, leaky sensors, line ruptures) by the pressure test. The SAK is closed and all pumps are running. ...

  • Page 118: Dynamic Tests And Controls During Therapy And Reinfusion

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION DYNAMIC TESTS AND CONTROLS DURING THERAPY AND REINFUSION 8.2.1 Blood Leak Detection A blood leak alarm can be caused by blood or an air bubble in the plasma line. The reason can also be a failure in the BLD selftest.

  • Page 119: Connection Test In Therapy And Reinfusion

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.2.2 Connection Test in Therapy and Reinfusion  Missing connection of the BicEL bags  Directly after start of Therapy a connection test of the buffer line with the acetate buffer bag is carried out.

  • Page 120: Alarms

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION ALARMS 8.3.1 Alarm Concept An alarm situation always requires special attention and immediate processing by the user. Alarms are displayed in the alarm/note line and accompanied by an acoustic alarm tone.
  • Page 121 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION An alarm is normally corrected in two steps:  Suppression of the alarm tone by pressing the key once.  Elimination of the cause of the alarm and subsequent acknowledgement of the alarm by pressing the key.

  • Page 122: List Of Alarms

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.3.2 List of Alarms If an alarm cannot be corrected with the measures described, if it occurs frequently and you cannot determine its cause or if a machine defect exists, please inform technical service.
  • Page 123 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Safety air detector (SAD) Hardware problem  Acknowledge the alarm (twice). If the test failed alarm is repeated switch the machine off and on again. ...
  • Page 124 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Weight test error. Check It was determined with  Ensure for 1. that: bag, clamps, connections weight test that  The seal on the saline bag is open. and pump! 1.
  • Page 125 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Leakage test failed. An error occurred during  Ensure that: Check connections the check of the safety air  The venous line is inserted in the filters and sensors! clamp (SAK) and the line safety air clamp (SAK).
  • Page 126 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Air in the venous line. Air found in venous line  Clamp shut the venous line with the Set PV to -50 mmHg to clamp between the plasma filter remove the air.
  • Page 127 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Minimum plasma Plasma pressure too low,  Ensure that: pressure (PPL) plasma flow too high  The blood flow/plasma flow ratio is approximately 3:1. ...
  • Page 128 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Maximum dialysis filter Dialyzer pressure too high  Ensure that: pressure (PDF)  The lines after the dialyzer are not kinked or clamped. ...
  • Page 129 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Fluid level in heparin HCLD detects air  Check whether the precipitate filter is adsorber chamber too Defect of automatic level saturated. If this is the case, replace low.
  • Page 130 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Excessive weight change, Weight variation  Ensure that: check bags and lines! between 50 and 200 g for  The bags are hanging motionless more than 5 s or weight on the load cell.
  • Page 131 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Alarm text Alarm cause Corrective action Reinfusion volume Balance error in plasma  Ensure that the pump segments (DP wrong. Check dial./UF reinfusion phase. and UFP) are inserted properly. lines and clamps.
  • Page 132 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Alarms marked with (S) (A80 – A104) are alarms which are generated by the supervisor. If these alarms are active, it is possible that the controller does not operate correctly. If an alarm cannot be corrected with the actions suggested below or if it occurs frequently, inform technical service.
  • Page 133 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION (S) Safety air detector Calibration or hardware  Switch the machine off and on again. (SAD) test failed! problems (S) Air in venous line Air found in venous line  Clamp the venous line with the clamp between the plasma filter (venous outlet) and the venous chamber.
  • Page 134 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION A103 (S) Balance error Balance error > 500 g  Ensure that: Defect of plasma/buffer  The seals of the saline bags and of pump, of ultrafiltration the dialysate bags are open. pump or of load cell ...

  • Page 135: Warnings

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION WARNINGS 8.4.1 Warning Concept Warnings are given when:  The user should perform a certain action.  A certain state must be pointed out to the user. Warnings are always accompanied by acoustic warning tones. Warnings which serve to point out a situation are displayed in the Alarm/Note field.
  • Page 136 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION This kind of warning is also indicated by the yellow LEDs lighting above the key. B|BRAUN Rev. 3.03.00 Page 30 of 46 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 137: List Of Warnings

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.4.2 List of Warnings M = Display in the message box T = Display in the alarm/note line Code Warning Text Reason for Warning Corrective Action Plasma pump starts after Indication that pressurization blood side...
  • Page 138 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Warning Text Reason for Warning Corrective Action Rinsing completed. For The minimum rinsing  Confirm the warning with the further rinsing set new volume of 2400 ml has key. value! been reached.
  • Page 139 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Code Warning Text Reason for Warning Corrective Action Balance error > 300 g Balancing error of more  Ensure that: Check lines and bags! than 300 g  Bags and lines are hanging free. ...
  • Page 140 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION High UF correction! UF- The correction value of  Check the bags on the lead cell for filter SMC? If not, check the UF is higher than leakages and correct connection. bags for leakage.
  • Page 141 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Attention! Precipitate PPF chamber level is too  Ensure that: filter rupture possible! high, PPF protector is wet.  The PPF chamber level is not Precipitate chamber level, No PPF pressure increase too high and PPF protector is protector in case of closed HAK...
  • Page 142 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Plasma pump is too slow. Plasma/buffer pump runs  Adapt the PPL threshold to the Check and decrease PPL constantly with 2 ml/min. current PPL. threshold.  Increase the plasma flow by increasing the blood pump speed and/or the plasma pump speed.
  • Page 143 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Acetate buffer System tests correct  No corrective action required! connection test. DP/UFP connection acetate pumps are stopped. buffer beginning therapy. Both dialysis pumps are standing still during the test. Reinfusion System tests...

  • Page 144: Problem Correction

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION PROBLEM CORRECTION 8.5.1 Balance Reset Balance error > 200 g For a balance error > 200 g, the alarm <A69: Balance error!> and the warning <W28: Balance error> are displayed. ...
  • Page 145 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION Balance error > 400 g If it was not possible to correct the balance error with the measures described above and it exceeds a value of 400 g, the alarm <A69: Balance error!> is initiated again and the warning <W25: Balance error >...

  • Page 146: Deaeration Of The Heparin Adsorber

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.5.2 Deaeration of the Heparin Adsorber If the fluid level in the heparin adsorber drops during the therapy, it can be refilled. Permanently too low fluid levels in the heparin adsorber can result in a decreased adsorption efficiency.
  • Page 147 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION  Check also whether sufficient dialysate is available and replace dialysate bags if necessary.  Confirm the change by pressing the key.  Continue the therapy by selecting the <Start Therapy> function. Change of the dialysate bags if they are nearly empty If the ratio dialysate/plasma is >...

  • Page 148: Changing The Plasma Filter

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.5.4 Changing the Plasma Filter Material Article number Haemoselect L 0.5 7061007C 2 x collection bags 7210929 3 l H.E.L.P. 0.9 % NaCl- 4107 solution 0.9% NaCl 3 collection lines 7210934 7500 IU heparin ...

  • Page 149: Changing The H.e.l.p. Precipitate Filter

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.5.5 Changing the H.E.L.P. Precipitate Filter Material Article number H.E.L.P. precipitate filter 7210931 2 x collection bags 7210929 3 l 0.9% H.E.L.P. NaCl solution 4107 3 connection lines 7210934 0.9 % NaCl ...

  • Page 150: Changing The H.e.l.p. Heparin Adsorber

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.5.6 Changing the H.E.L.P. Heparin Adsorber Material Article number H.E.L.P. heparin adsorber 400 7211089 1 x collection bag 7210929 3 l H.E.L.P. 0.9% NaCl solution 4107 0.9% NaCl 2 connection lines 7210934 ...

  • Page 151: Changing The H.e.l

    Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION 8.5.7 Changing the H.E.L.P. Ultrafilter Material Article number H.E.L.P. Ultrafilter HIPS 20 7211101 1 x collection bag 7210929 0.9% NaCl 3 l H.E.L.P. 0.9 % NaCl solution 4107 2 connection lines 7210934 ...
  • Page 152 Chapter 8 H.E.L.P. Plasmat® Futura SELFTESTS, ALARMS AND PROBLEM CORRECTION B|BRAUN Rev. 3.03.00 Page 46 of 46 SHARING EXPERTISE Art. No. 38910323ENCA...
  • Page 153 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION 9 Technical Information..........3 TRANSPORT .................. 3 9.1.1 Wheeling........................... 3 9.1.2 Carrying..........................4 OPERATING CONDITIONS ............5 9.2.1 Installation Site ......................5 9.2.2 Initial Commissioning ....................5 9.2.3 Service and Maintenance .................... 6 9.2.4 Disposables, Consumables and Accessories/Replacement Parts.......
  • Page 154 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION B|BRAUN Rev. 3.03.00 Page 2 of 20 SHARING EXPERTISE Art. No. 38910323ENCA...

  • Page 155: Technical Information

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Technical Information TRANSPORT Wheeling 9.1.1 Risk of damage if H.E.L.P. Plasmat® Futura is tilted by > 5°!  Have 2 or more persons at hand for transporting the machine on stairs and inclined areas. CAUTION ...

  • Page 156: Carrying

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Carrying 9.1.2 For carrying, the H.E.L.P. Plasmat® Futura can be held at the base, at the handles at the rear panel and at the protrusion at the front of the machine, as shown in the illustration below.

  • Page 157: Operating Conditions

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION OPERATING CONDITIONS The H.E.L.P. Plasmat® Futura may be operated only by trained specialist personnel. The instructions in the Instructions for Use for the machine, the disposables and consumables and the intended use must be followed. Installation Site 9.2.1 Installation must be done only by qualified and adequately trained staff.

  • Page 158: Service And Maintenance

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Service and Maintenance 9.2.3 Repairs and maintenance may be performed only by personnel authorized and trained by the manufacturer. No special maintenance by the user is required. The Technical Safety Inspection is to be performed every twelve months based on the Service Manual and the Instructions for Use, subject to technical changes, and to be documented.

  • Page 159: General Technical Data

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION GENERAL TECHNICAL DATA Machine dimensions Height 1330 mm Width 500 mm Depth 520 mm Weight 55 kg Electrical connection Rated voltage 110 – 240 V~ Overvoltage category Rated frequency 50/60 Hz FI circuit breaker 30 mA Class of protection 1, Type B, IP 21...

  • Page 160: Recommended Safe Distances

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Recommended Safe Distances 9.3.1 Recommended safe distances between portable or mobile HF telecommunication devices and H.E.L.P. Plasmat ® Futura The H.E.L.P. Plasmat® Futura is for the use in ambient conditions with controlled High Frequency disturbance variables.

  • Page 161: Relevant Pressures

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Relevant Pressures 9.4.1 Arterial pressure Arterial prefilter pressure After the blood pump is started and adapted and the automatic level adjustment of the arterial air chamber is activated, the lower and upper PBE limits are set within ten seconds in the therapy and momentary acquired...
  • Page 162 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Dialysate inlet pressure Venous pressure During therapy and reinfusion phase, 10 sec after start of blood pump or plasma pump, and after change of the blood flow, or after the manual level regulation of the venous or PBE chamber, respectively, the lower and upper PV limits are automatically adjusted.

  • Page 163: Limits Of Adjustable Parameters

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Limits of Adjustable Parameters 9.4.2 Parameter Default Step Unit sequence Blood flow ml/min Plasma flow % Blood flow Plasma reinfusion volume 1000 Blood reinfusion volume Reinfusion flow ml/min Ratio dialysate/plasma Rinsing volume 2400 2400 20.000 Plasma volume...

  • Page 164: Extracorporeal Blood Circuit

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Extracorporeal Blood Circuit 9.4.3 Blood pump (BP) Peristaltic roller pump with motor switch-off when the pump cover is open. Delivery rate 10 ÷ 150 ml/min Delivery rate tolerance < ± 10 % Working pressure range -140 ÷...
  • Page 165 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Venous pressure (PV) Electronically measured by a pressure sensor and digitally displayed Measurement range: -500 ÷ +500 mmHg Allowed tolerance: ± 10 mmHg Working range: +20 ÷ +50 mmHg During therapy: Alarm limits 0 (-10) ÷...
  • Page 166 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Heparin pump (HP) Syringe pump (calibrated to Perfusor syringe 30 ml Omnifix®) Delivery rate: 0 ÷ 10 ml/h, step 0.1 ml/h Delivery rate tolerance*: ±10% (below 1 ml/h after first delivered 0.05 ml) (*Note: In case of heparin flow below 1 ml/h, significant error can derive when the pump starts to move the plunger because of its positioning tolerances or simply due to flexibility of the plunger.)

  • Page 167: Plasma Circuit

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Plasma Circuit 9.4.4 Plasma/buffer pump (PBP) Peristaltic roller pump with motor switch-off when the pump cover is open (marked yellow) Delivery rate: 2 ÷ 50 ml/min Delivery rate tolerance: < ± 10 % Working range pressure: -100 ÷...
  • Page 168 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Precipitate filter pressure (PPF) Electronically measured by a pressure sensor and digitally displayed Measurement range: -500 ÷ +500 mmHg Allowed tolerance: ±10 mmHg Working range: +150 ÷ +300 mmHg During Therapy: Default alarm limits: -20 ÷...

  • Page 169: Dialyzing Circuit

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Dialyzing Circuit 9.4.5 Ultrafiltration pump (UFP) Peristaltic roller pump with motor switch-off when the pump cover is open (marked green) Delivery rate: 10 ÷ 300 ml/min Controlled by patient balance feedback control system (based on weight measurement by load cell).
  • Page 170 Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Plate warmer (H) Fluid warming system with temperature sensors based on heat transfer between temperature controlled metal plate and plastic dialysate bag. Temperature range: 34 ÷ 40°C Default in therapy: 39°C Allowed tolerance: 0.5°C Upper alarm limit: 41.5 °C for 10 seconds...

  • Page 171: Weight System

    Chapter 9 H.E.L.P. Plasmat® Futura TECHNICAL INFORMATION Weight System 9.4.6 Load cell Loading capacity: 30 kg Weight resolution: Allowed tolerance: ±20 g Working range: 0 – 25 kg Overload protection: electrically at 24.5 kg mechanically at 26 kg Weight change alarm: Weight deviation <...

  • Page 172: Warranty And Liability

    Instructions for Use. Warranty and Liability 9.5.2 For the H.E.L.P. Plasmat® Futura, B. Braun Avitum AG grants 12 months guarantee as from the initial installation. The guarantee comprises the repair or the replacement of defective parts, providing they have design, production or material defects.

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