Fresenius Medical Care 5008 Operating Instructions Manual
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Fresenius Medical Care 5008 Operating Instructions Manual

Hemodialysis system
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5008
Hemodialysis System

Operating Instructions

Software version: 3.52
Edition: 5/09.06
Part no.: M38 816 1
0123
Fresenius Medical Care

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Summary of Contents for Fresenius Medical Care 5008

  • Page 1: Operating Instructions

    5008 Hemodialysis System Operating Instructions Software version: 3.52 Edition: 5/09.06 Part no.: M38 816 1 0123 Fresenius Medical Care...

  • Page 3: Table Of Contents

    Examples for Data Entry (Treatment Data) ................4-7 Screen Saver..........................4-9 Preparation Preparation using ONLINEplus™ ................... 5-1 Preparation with Rinse Solution Bag ..................5-17 Single-Needle (Option) Preparation Using ONLINEplus™ ..........5-31 Single-Needle (Option) Preparation with Rinse Solution Bag..........5-47 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 4 Micro Bubbles Detected Below the Venous Bubble Catcher ..........9-7 Management of Alarm Limits....................9-14 Blood Leak ..........................9-14 Conductivity ..........................9-15 Manually Opening the Arterial Pressure Measurement Unit ..........9-15 Power Failure (Outage) ......................9-15 Screen Failure .......................... 9-17 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 5 12.1 To be Observed in Chapter Consumables ................12-1 12.2 Dialyzers........................... 12-1 12.3 Blood Lines ..........................12-1 12.4 Disposable Syringes ....................... 12-2 12.5 Hemodialysis Concentrates ....................12-2 ® 12.6 Dialysate Filter DIASAFE plus....................12-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 6 18 Option BPM (Blood Pressure Monitoring) 18.1 To Be Observed Before Using the BPM Option..............18-1 18.2 Blood Pressure Cuffs / Pressure Tubing................18-1 18.3 Menu Overview ........................18-2 18.4 Applying the Blood Pressure Cuff ..................18-3 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 7 To Be Observed Before Using the Network ................22-1 22.2 DataXchange Panel ......................... 22-1 23 Options BLK, WET 23.1 To be Observed Before Using the BLK, WET Options............23-1 23.2 BLK ............................23-1 23.3 WET............................23-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 8 Table of Contents Page 24 Option smartbag 24.1 To Be Observed Before Using the smartbag Option............24-1 24.2 Connecting the smartbag ....................... 24-1 24.3 Removing the smartbag......................24-2 viii Fresenius Medical Care 5008 OP 5/09.06...
  • Page 9 Connection, venous pressure line Audible alarm suppression 11-6 11-34 11-36 11-38 11-40 Blood pump 3-8 3-10 10-2 Auto On 10-18 Connector for BIC, blue 3-14 Body temperature control 11-14 AutoFlow 11-9 Connector for CDS 1, red 3-14 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 10 Dialyzer holder 3-4 Filter chamber 3-4 Dialyzer, emptying 7-2 Fixation for the plunger (heparin Dialyzers 12-1 pump) 3-10 Identification 2-1 DIASAFE®plus 11-12 12-2 Flow alarm 11-11 Indibag flap 3-13 DIASAFE®plus, changing 10-27 Flow diagram 11-26 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 11 Materials used 11-17 Rinse/reinfusion volume 10-3 Patient, connecting with ONLINE Menu buttons 4-3 and Single-Needle 6-9 Rocker switch 4-8 Menu panel 4-3 Patient, disconnecting with Room temperature 10-25 Menu structure, design 4-6 ONLINE 7-1 Rotor 3-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 12 Tubing system, inserting with rinse solution bag 5-24 smartbag 24-1 Tubing system, inserting with rinse SN chamber 11-13 11-39 11-41 Warning 9-1 solution bag in case of Single- SN line guide 11-39 11-41 Needle 5-54 Warranty 2-5 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 13 Chapter 1: Index Water alarms 11-53 Water supply 11-44 11-45 Water supply (permeate) 3-14 Weekly programs 10-18 Weight 11-1 WET 23-1 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 14 Chapter 1: Index Fresenius Medical Care 5008 OP 5/09.06...

  • Page 15: Important Information

    Description of the options Chapters 15 to 28 describe the operation of the options. For further information please refer to the appropriate chapters. (e.g. The SN Specifications are listed in chapter 11 System Description.) Fresenius Medical Care 5008 OP 5/09.06...
  • Page 16 2.1.3 Signification of the Highlight Symbol Explanation on the following symbol: Here you will find hints on easy handling. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 17: Important Information On The System

    The arterial pressure monitoring unit detects an aspiration of the needle in the vessel. The hemodialysis system 5008 is designed for both acetate dialysis and bicarbonate dialysis. The mixing ratio, the Na concentration and the bicarbonate concentration may be programmed within certain limits.

  • Page 18: Contraindications

    Chapter 2: Important Information 2.2.2 Intended Use Fields of application The 5008 hemodialysis system is designed for performing chronic and acute hemodialysis. It can be used in home dialysis, hemodialysis and limited care centers and clinical hemodialysis. Side effects Hemodialysis therapies occasionally cause hypotension, nausea, vomiting and cramps in some patients.

  • Page 19: Disclaimer Of Liability

    When cleaning the RO unit and its supply lines, the hemodialysis system must be disconnected from the RO unit at the water supply. During cleaning of the CDS distribution tubings, the hemodialysis system must be separated from the CDS. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 20: Additional Optional Equipment

    Prior to the initial start-up thoroughly study the information given in chapter 11. 2.2.10 Start-Up Requirements The 5008 hemodialysis system must be in a perfect state. If the 5008 hemodialysis system shows signs of mechanical damage preventing safe operation, stop using the machine. Applied parts that are damaged must be replaced.

  • Page 21: Repair

    – Test procedure by which the effectiveness of sterilization or disinfection has been verified. – Comments, concerning the expected recirculation of the blood flow in the extracorporeal circuit in Single-Needle treatments, if the recommended administration sets, dialyzers, fistula needles and catheters are used. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 22: Addresses

    Chapter 2: Important Information Addresses Please address any inquiries to: Manufacturer Fresenius Medical Care AG & Co. KGaA D-61346 Bad Homburg +49 (0)6172/609-0 www.fmc-ag.com Service Fresenius Medical Care Central Europe Deutschland GmbH Geschäftsbereich Zentraleuropa Kundendienst / Servicecenter Steinmühlstraße 24 61352 Bad Homburg...

  • Page 23: Design

    Chapter 3: Design Design Front View Monitor Extracorporeal blood module Hydraulics Fresenius Medical Care 5008 OP 5/09.06...

  • Page 24: Rear View

    Chapter 3: Design Rear View Monitor External connection options Push handle Fan filter (service door) Power connection (supply point) Line holder (for transport) Service door Hydraulic connectors Fresenius Medical Care 5008 OP 5/09.06...

  • Page 25: Lateral View, Left Side

    Push with your foot from the front against the rack until it clicks into place. To apply or release the brake: (a) Push the lever down to apply the brake. (b) Push the lever down to release the brake. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 26: Lateral View, Right Side

    Dialysate supply line (dialyzer coupling red) Concentrate rack (extractable) Brake Leakage sensor, filter chamber Particle filter, dialysate ® Filter 1 – DIASAFE plus, right Filter 2 – ONLINEplus™, left Door, filter chamber Filter chamber Fresenius Medical Care 5008 OP 5/09.06...

  • Page 27: Dialysate Couplings

    (a). Close the shunt door by flipping it down (b). To remove the dialysate couplings: Push the lever down and hold it, and remove the dialysate coupling. To move the hemodialysis system: The hemodialysis system can be moved in all directions. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 28: Monitor Front

    LED is yellow in case of a warning or an info. LED is yellow and flashing in Emergency mode. LED is red in case of an alarm. LED is not illuminated during the cleaning programs. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 29: Monitor Rear

    To move the monitor: To bring the monitor into the desired position, it can be swiveled about three axes (a), (b), (c). (a) To move it, hold the monitor at the points shown. (b) Insert card. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 30: Extracorporeal Blood Module

    Rinse port, hidden by the rinse port catch (grey) Rinse port catch (grey) Groove Leakage sensor, extracorporeal blood module Venous occlusion clamp Venous monitoring function (optical detector, air bubble detector) Locator for venous bubble catcher Venous monitoring function (level detector) Fresenius Medical Care 5008 OP 5/09.06...

  • Page 31: Line Holder For Safeline™

    Chapter 3: Design Line holder for SafeLine™ Line holder Venous pressure port Open or close the doors on the upper side as shown in the illustration. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 32: Handle For An Emergency Operation

    Holder (shape-coded) for line guide Rotor Handle for an emergency operation Key/ejector (for inserting and removing the line segment) Line pulleys Heparin pump Barrel holder with syringe detector Bracket Fixation for the plunger Grip handle Clamping brackets 3-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 33 Chapter 3: Design Venous fill level and air monitoring function Tension lever with level detector (for the venous bubble catcher) Locator for venous bubble catcher Optical detector Air bubble detector (ABD) Line housing Fresenius Medical Care 5008 OP 5/09.06 3-11...

  • Page 34: Extracorporeal Blood Module With Additional Functions

    Pressure port (BPM) Pressure tubing SN (option) Single-Needle pressure port Single-Needle pump Holder for SN chamber (with mark) BVM (option) BVM measuring head BTM (option) Arterial measuring head (BTM) Venous measuring head (BTM) 3-12 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 35: Hydraulics

    Chapter 3: Design Hydraulics Bicarbonate flap Bicarbonate suction tube (blue) ® bibag port Indibag flap ® indibag port Concentrate flap ® sobag port Concentrate suction tube (red) Fresenius Medical Care 5008 OP 5/09.06 3-13...

  • Page 36: Hydraulics Connectors

    Vent (water inlet chamber) Vent (mixing chamber) Connector for CDS 1, red (Central Delivery System) acid 1 Connector for CDS 2, red (Central Delivery System) acid 2 (option) Connector for BIC, blue (central bicarbonate supply) (option) 3-14 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 37: External Connection Options/Connection To Power Supply

    Before connecting any optional equipment, observe the notes under Specifications. LAN (local area network) network connection Service/diagnostics, RS232, 24 V Connector for AquaUNO (single station reverse osmosis unit) Alarm output (staff call) Power connection (supply point) Power switch Fresenius Medical Care 5008 OP 5/09.06 3-15...
  • Page 38 Chapter 3: Design 3-16 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 39: Graphical User Interface

    (on request) for approx. 15 seconds. SELECTION SCREEN The following selections are possible: – Treatment – Cleaning program (e.g. Rinse) Touch the desired button to make your selection. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 40: Overview (Screen)

    – Bypass – waves green (grey bar is not moving.) – Flow turned off – waves grey Status Displays data on the system condition. (Software, error memory, cleaning status, system info) Message button Allows retrieval of information, warnings and alarms (3 maximum) Fresenius Medical Care 5008 OP 5/09.06...

  • Page 41: General Operation Philosophy

    The alarm window is displayed in block representation, according to the window size. Touch the ART or VEN field for setting the alarm limits. General Operation Philosophy It is possible to control all treatment sections via the screen menu. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 42: Header Bar

    BLUE GREEN GREY Selection possible Active Not active Example Examples Examples Emergency menu I/O indicator UF goal value field UF Timer I/O indicator UF MENU button TREATMENT button Selection not possible Example CLEANING button Fresenius Medical Care 5008 OP 5/09.06...

  • Page 43: Course Of The Treatment

    9 menu buttons in 3-D-design are placed at the bottom screen bar, representing the chronological course of operation. The change to the corresponding menus is performed automatically when the respective conditions have been fulfilled. (Exception: DIALYSATE MENU, UF MENU, OPTIONS and SYSTEM) Fresenius Medical Care 5008 OP 5/09.06...
  • Page 44 Touching the OK button accepts changed data. To enter data for more parameters, touch this OK level button to accept the changed data and to open the respective menu. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 45: Examples For Data Entry (Treatment Data)

    Check the entered value (prescribed value). (Grey keys prevent implausible entries.) 3. Touch the OK button to accept the entered value. Visually check the accepted value. 4. Touch the C button for making corrections. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 46: Rocker Switch

    Check the entered alarm window value in the venous pressure display (prescribed value). 4. Touch the OK button to accept the selected alarm window. Visually check the accepted alarm window. 5. Touch the C button for making corrections. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 47: Screen Saver

    The SCREEN SAVER disappears when any part of the screen is touched. The SCREEN SAVER disappears immediately: – when a message is given (info, warning or alarm), – when the BPM (optional) starts a measurement. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 48 Chapter 4: Graphical User Interface 4-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 49 Fold-Out Sheet Preparation Fresenius Medical Care 5008 OP 5/09.06...
  • Page 50 Connecting the concentrate container (e.g. acid) PREPARATION SCREEN ® Connecting the bag (e.g. bibag DIALYSATE SCREEN BLOOD SYSTEM SCREEN UF SCREEN PREPARATION SCREEN HEPARIN SCREEN...

  • Page 51: Preparation

    NaCl bags. The fluid volumes required for preparation, bolus administration or during reinfusion will then be produced ONLINE by the 5008 hemodialysis system according to the actual requirements, thus saving both cost and time. 5.1.1...
  • Page 52 If connectors made of polycarbonate are for example exposed to aqueous solutions with the pH value > 10 or to aliphatic solutions this will cause tension cracks. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 53 – Use only the dedicated coded containers or the bibag bicarbonate dialysis. ® Bicarbonate dry concentrate bibag ® Only the bibag manufactured by Fresenius Medical Care may be used. ® The bibag must only be used for one treatment. ® Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution.
  • Page 54 The color of the header bar is orange for the duration of the T1 test. The operating mode display shows the progress of the T1 test. Message: T1 test completed is displayed for a moment after successful completion of the T1 test. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 55 All affected components have to be disinfected or replaced in accordance with the manufacturer's specifications before the system is put into operation again. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 56 If heparin syringes without Luer lock are used it is the operator’s responsibility to ensure that the connection between the heparin syringe and the blood lines does not loosen inadvertently. IV pole: Securely fix bags or other objects to be hung from the IV pole. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 57 If the blood lines were inserted more than 8 hours before the treatment, malfunctions may occur. Correcting these malfunctions may require removing the present blood lines and inserting new blood lines. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 58 3 Connect the arterial blood line to the lower port of the dialyzer. 4 Insert the arterial pressure dome into the arterial pressure measurement unit. 5 Insert the arterial blood line into the arterial occlusion clamp. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 59 13 Insert the SafeLine™ line guide into the substituate pump until a signal is sounded. (After closing the doors the SafeLine™ pump segment will be automatically inserted into the substituate pump.) 14 Insert the SafeLine™ into the line holder. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 60 (grey). Close the doors. (The line segment(s) are automatically inserted, the arterial pressure measurement unit closes.) The system automatically switches to the PREPARATION SCREEN. Message: Connect dialyzer couplings! 5-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 61 Touch the Blood pump I/O button. (Blood pump I/O indicator grey.) Message: Do not connect patient! Minimum rinse volume not reached. – Rinse Continue Touch the Continue button to continue rinsing. (Blood pump I/O indicator green.) Fresenius Medical Care 5008 OP 5/09.06 5-11...
  • Page 62 Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5.1.9 Checking/Setting the UF Parameters On the PREPARATION SCREEN you can directly check, select and change the UF goal, UF time and UF rate parameters. 5-12 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 63 KT/V = 1.2. In case of higher deviations (KT/V > 1.4; KT/V < 1.0) the balancing neutrality may not always be achieved. Basic requirements for setting the profiles: the UF parameters must have been set. Fresenius Medical Care 5008 OP 5/09.06 5-13...
  • Page 64 Set the desired parameters. Touch the OK button to confirm the entered values. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-14 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 65: Heparin Menu

    Check the heparin pump parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. Fresenius Medical Care 5008 OP 5/09.06 5-15...
  • Page 66 Chapter 5: Preparation 5-16 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 67: Preparation With Rinse Solution Bag

    5.2.1 Turning the Hemodialysis System On Caution The stability of the 5008 hemodialysis system must be ensured. Establish the water and power supply. Press the On/Off key. (Turn the hemodialysis system on!) The On/Off LED is illuminated.
  • Page 68 If connectors made of polycarbonate are for example exposed to aqueous solutions with the pH value > 10 or to aliphatic solutions this will cause tension cracks. 5-18 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 69 – Use only the dedicated coded containers or the bibag bicarbonate dialysis. ® Bicarbonate dry concentrate bibag ® Only the bibag manufactured by Fresenius Medical Care may be used. ® The bibag must only be used for one treatment. ® Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution.
  • Page 70 The color of the header bar is orange for the duration of the T1 test. The operating mode display shows the progress of the T1 test. Message: T1 test completed is displayed for a moment after successful completion of the T1 test. 5-20 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 71 All affected components have to be disinfected or replaced in accordance with the manufacturer's specifications before the system is put into operation again. Fresenius Medical Care 5008 OP 5/09.06 5-21...
  • Page 72 IV pole: Securely fix bags or other objects to be hung from the IV pole. 5-22 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 73 If the blood lines were inserted more than 8 hours before the treatment, malfunctions may occur. Correcting these malfunctions may require removing the present blood lines and inserting new blood lines. Fresenius Medical Care 5008 OP 5/09.06 5-23...
  • Page 74 4 Insert the arterial pressure dome into the arterial pressure measurement unit. 5 Insert the arterial blood line into the arterial occlusion clamp. 6 Connect the arterial patient connection of the tubing system to the rinse solution bag. 5-24 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 75 (Prime collection bag not included in scope of delivery of the tubing system.) Close the doors. (The line segment(s) are automatically inserted, the arterial pressure measurement unit closes.) Break the cone on the rinse solution bag. Fresenius Medical Care 5008 OP 5/09.06 5-25...
  • Page 76 Touch the Blood pump I/O button. (Blood pump I/O indicator grey.) Message: Do not connect patient! Minimum rinse volume not reached. – Rinse Continue Do not connect a patient if rinsing is interrupted during the T1 test or during a cleaning program. 5-26 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 77 Prescr. Na and Prescr. Bic parameters. In the DIALYSATE MENU Check the dialysate parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Fresenius Medical Care 5008 OP 5/09.06 5-27...
  • Page 78 The UF goal/UF time or UF goal/UF rate parameters must first be entered. Set the desired parameters. Touch the OK button to confirm the entered values. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-28 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 79 Profiles 1, 2: UF goal 200 ml, UF time 2:00 hrs, UF rate 10 ml Profile 3: UF goal 200 ml, UF time 3:30 hrs, UF rate 10 ml Set the desired profile. Check/set the start rate. (The minimum profile rate is automatically adjusted.) Fresenius Medical Care 5008 OP 5/09.06 5-29...
  • Page 80 Check the heparin pump parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-30 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 81: Single-Needle (Option) Preparation Using Onlineplus

    NaCl bags. The fluid volumes required for preparation, bolus administration or during reinfusion will then be produced ONLINE by the 5008 hemodialysis system according to the actual requirements, thus saving both cost and time. 5.3.1...
  • Page 82 If connectors made of polycarbonate are for example exposed to aqueous solutions with the pH value > 10 or to aliphatic solutions this will cause tension cracks. 5-32 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 83 – Use only the dedicated coded containers or the bibag bicarbonate dialysis. ® Bicarbonate dry concentrate bibag ® Only the bibag manufactured by Fresenius Medical Care may be used. ® The bibag must only be used for one treatment. ® Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution.
  • Page 84 The color of the header bar is orange for the duration of the T1 test. The operating mode display shows the progress of the T1 test. Message: T1 test completed is displayed for a moment after successful completion of the T1 test. 5-34 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 85 All affected components have to be disinfected or replaced in accordance with the manufacturer's specifications before the system is put into operation again. Fresenius Medical Care 5008 OP 5/09.06 5-35...
  • Page 86 IV pole: Securely fix bags or other objects to be hung from the IV pole. 5-36 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 87 If the blood lines were inserted more than 8 hours before the treatment, malfunctions may occur. Correcting these malfunctions may require removing the present blood lines and inserting new blood lines. Fresenius Medical Care 5008 OP 5/09.06 5-37...
  • Page 88 5 Connect the arterial blood line to the lower port of the dialyzer. 6 Insert the arterial pressure dome into the arterial pressure measurement unit. 7 Insert the arterial blood line into the arterial occlusion clamp. 5-38 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 89 15 Insert the SafeLine™ line guide into the substituate pump until a signal is sounded. (After closing the doors the SafeLine™ pump segment will be automatically inserted into the substituate pump.) 16 Insert the SafeLine™ into the line holder. Fresenius Medical Care 5008 OP 5/09.06 5-39...
  • Page 90 (grey). Close the doors. (The line segment(s) are automatically inserted, the arterial pressure measurement unit closes.) The system automatically switches to the PREPARATION SCREEN. Message: Connect dialyzer couplings! 5-40 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 91 Touch the Blood pump I/O button. (Blood pump I/O indicator grey.) Message: Do not connect patient! Minimum rinse volume not reached. – Rinse Continue Touch the Continue button to continue rinsing. (Blood pump I/O indicator green.) Fresenius Medical Care 5008 OP 5/09.06 5-41...
  • Page 92 Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5.3.9 Checking/Setting the UF Parameters On the PREPARATION SCREEN you can directly check, select and change the UF goal, UF time and UF rate parameters. 5-42 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 93 KT/V = 1.2. In case of higher deviations (KT/V > 1.4; KT/V < 1.0) the balancing neutrality may not always be achieved. Basic requirements for setting the profiles: the UF parameters must have been set. Fresenius Medical Care 5008 OP 5/09.06 5-43...
  • Page 94 Set the desired parameters. Touch the OK button to confirm the entered values. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-44 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 95 Check the Single-Needle parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. Fresenius Medical Care 5008 OP 5/09.06 5-45...
  • Page 96 Chapter 5: Preparation 5-46 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 97: Single-Needle (Option) Preparation With Rinse Solution Bag

    5.4.1 Turning the Hemodialysis System On Caution The stability of the 5008 hemodialysis system must be ensured. Establish the water and power supply. Press the On/Off key. (Turn the hemodialysis system on!) The On/Off LED is illuminated.
  • Page 98 If connectors made of polycarbonate are for example exposed to aqueous solutions with the pH value > 10 or to aliphatic solutions this will cause tension cracks. 5-48 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 99 – Use only the dedicated coded containers or the bibag bicarbonate dialysis. ® Bicarbonate dry concentrate bibag ® Only the bibag manufactured by Fresenius Medical Care may be used. ® The bibag must only be used for one treatment. ® Only use the bibag in combination with acid bicarbonate hemodialysis concentrate according to the prescribed dilution.
  • Page 100 The color of the header bar is orange for the duration of the T1 test. The operating mode display shows the progress of the T1 test. Message: T1 test completed is displayed for a moment after successful completion of the T1 test. 5-50 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 101 All affected components have to be disinfected or replaced in accordance with the manufacturer's specifications before the system is put into operation again. Fresenius Medical Care 5008 OP 5/09.06 5-51...
  • Page 102 IV pole: Securely fix bags or other objects to be hung from the IV pole. 5-52 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 103 If the blood lines were inserted more than 8 hours before the treatment, malfunctions may occur. Correcting these malfunctions may require removing the present blood lines and inserting new blood lines. Fresenius Medical Care 5008 OP 5/09.06 5-53...
  • Page 104 6 Insert the arterial pressure dome into the arterial pressure measurement unit. 7 Insert the arterial blood line into the arterial occlusion clamp. 8 Connect the arterial patient connection of the tubing system to the rinse solution bag. 5-54 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 105 (Prime collection bag not included in scope of delivery of the tubing system.) Close the doors. (The line segment(s) are automatically inserted, the arterial pressure measurement unit closes.) Break the cone on the rinse solution bag. Fresenius Medical Care 5008 OP 5/09.06 5-55...
  • Page 106 Touch the Blood pump I/O button. (Blood pump I/O indicator grey.) Message: Do not connect patient! Minimum rinse volume not reached. – Rinse Continue Do not connect a patient if rinsing is interrupted during the T1 test or during a cleaning program. 5-56 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 107 Prescr. Na and Prescr. Bic parameters. In the DIALYSATE MENU Check the dialysate parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Fresenius Medical Care 5008 OP 5/09.06 5-57...
  • Page 108 The UF goal/UF time or UF goal/UF rate parameters must first be entered. Set the desired parameters. Touch the OK button to confirm the entered values. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-58 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 109 Profiles 1, 2: UF goal 200 ml, UF time 2:00 hrs, UF rate 10 ml Profile 3: UF goal 200 ml, UF time 3:30 hrs, UF rate 10 ml Set the desired profile. Check/set the start rate. (The minimum profile rate is automatically adjusted.) Fresenius Medical Care 5008 OP 5/09.06 5-59...

  • Page 110: Heparin Pump Parameters

    Check the Single-Needle parameters. Set the desired parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the PREPARATION menu button to return to the PREPARATION SCREEN. 5-60 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 111 Fold-Out Sheet Treatment Fresenius Medical Care 5008 OP 5/09.06...
  • Page 112 TREATMENT SCREEN SN, setting the level in the SN chamber...

  • Page 113: Treatment

    NaCl bags. The fluid volumes required for preparation, bolus administration or during reinfusion will then be produced ONLINE by the 5008 hemodialysis system according to the actual requirements, thus saving both cost and time. 6.1.1 Connecting the Patient —...
  • Page 114 Touch the TREATMENT menu button to return to the TREATMENT SCREEN. Note When administering larger volumes of substitution fluid, the blood may be diluted to an extent which causes the optical detector to sense light. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 115 Visually check the confirmed values. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. During the treatment, it is possible to increase the maximum possible UF rate in the Operator setup. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 116 How to change heparin pump parameters: Set the desired heparin pump parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 117: Treatment (Prepared With Rinse Solution Bag)

    Chapter 6: Treatment Treatment (Prepared with Rinse Solution Bag) If the 5008 ONLINEplus™ hemodialysis system cannot be operated without rinse solution bags, rinse or infusion solutions provided in NaCl bags may be used instead. 6.2.1 Connecting the Patient — Double-Needle Dialysis (Prepared with Rinse Solution...
  • Page 118 If sodium or UF profiles are programmed during the treatment, they will start with a delay time of 20 seconds. Starting Automatically, if OD dark (adjustable in the Operator setup). Touch the UF timer I/O button. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 119 Message: No blood detected. – Dialysis Continue – Reinfusion Start – Machine Remove lines The blood pump stops. The arterial/venous occlusion clamp closes. Mute LED is flashing. Audible signal Touch the Continue button to go on with the dialysis treatment. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 120 Chapter 6: Treatment Fresenius Medical Care 5008 OP 5/09.06...

  • Page 121: Single-Needle (Option) Treatment Using Onlineplus

    NaCl bags. The fluid volumes required for preparation, bolus administration or during reinfusion will then be produced ONLINE by the 5008 hemodialysis system according to the actual requirements, thus saving both cost and time. 6.3.1 Connecting the Patient —...
  • Page 122 Disconnect the venous tubing system from the rinse connector and connect it to the patient or, if desired, to a separate prime collection bag. Close the rinse port. Message: Start the blood pump – Confirm Touch the Confirm button. 6-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 123 Set the desired Online parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. 6.3.3 ONLINEplus™ Bolus Administration Touch the ONLINE menu button. Fresenius Medical Care 5008 OP 5/09.06 6-11...
  • Page 124 Message: Set the level in the SN chamber to the mark. Level – Level set OK – Abort Touch the button to set the level to the mark of the SN chamber holder. (The doors must be closed.) Touch the OK button. 6-12 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 125 Na and prescribed Bic parameters. The DIALYSATE MENU is used to set the flow through the dialyzer. (In case of ONLINEplus™, the total flow consists of the set flow and the respective substituate rate.) Fresenius Medical Care 5008 OP 5/09.06 6-13...
  • Page 126 Touch the UF timer I/O button. Stopping/aborting Touch the UF timer I/O button. Message: UF profile and Na profile were stopped. – Both profiles Abort – UF profile Abort – Treatment Continue Touch the desired button. 6-14 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 127 How to change heparin pump parameters: Set the desired heparin pump parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. Fresenius Medical Care 5008 OP 5/09.06 6-15...
  • Page 128 Chapter 6: Treatment 6-16 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 129: Single-Needle (Option) Treatment (Prepared With Rinse Solution Bag)

    Chapter 6: Treatment Single-Needle (Option) Treatment (Prepared with Rinse Solution Bag) If the 5008 ONLINEplus™ hemodialysis system cannot be operated without rinse solution bags, rinse or infusion solutions provided in NaCl bags may be used instead. 6.4.1 Connecting the Patient — Single-Needle Dialysis (Prepared with Rinse Solution...
  • Page 130 Backfiltration depends on: – the type of high-flux dialyzer – the different flow resistances on the dialysate and the blood side – the viscosity of the blood Touch the Double-Needle dialysis Start button. 6-18 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 131 Aborting SN during the Treatment In the SINGLE-NEEDLE menu Touch the Single-Needle I/O button. (Single-Needle I/O indicator grey.) Message: Connect the arterial and the venous patient line to the respective vascular access. – Double-Needle Start – Abort Fresenius Medical Care 5008 OP 5/09.06 6-19...
  • Page 132 How to change dialysate parameters: Set the desired dialysate parameters. Touch the OK button to confirm the values entered. Visually check the confirmed values. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. 6-20 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 133 If no button is touched, the profiles will be stopped for a certain time (adjustable in the Operator setup). 6.4.9 Changing the Heparin Pump Parameters In the HEPARIN menu Touch the Heparin I/O button to turn the heparin pump on or off. Fresenius Medical Care 5008 OP 5/09.06 6-21...
  • Page 134 Message: No blood detected. – Dialysis Continue – Reinfusion Start – Machine Remove lines The blood pump stops. The arterial/venous occlusion clamp closes. Mute LED is flashing. Audible signal Touch the Continue button to go on with the dialysis treatment. 6-22 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 135 Fold-Out Sheet Reinfusion Fresenius Medical Care 5008 OP 5/09.06...
  • Page 136 REINFUSION SCREEN...

  • Page 137: Reinfusion

    NaCl bags. The fluid volumes required for preparation, bolus administration or during reinfusion will then be produced ONLINE by the 5008 hemodialysis system according to the actual requirements, thus saving both cost and time. 7.1.1 Disconnecting the Patient —...
  • Page 138 Turn the dialyzer. The dialysate inlet port must be at the upper end. Open the shunt door. Place the dialysate supply line (red) on the red color-coded position. Close the shunt door. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 139 Discard the extracorporeal blood circuit after the treatment. Observe the regulations for the handling of potentially contaminated materials. Remove the blood lines. Close the doors. Caution It is imperative to disinfect the system after each treatment. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 140 Chapter 7: Reinfusion Fresenius Medical Care 5008 OP 5/09.06...

  • Page 141: Reinfusion With Rinse Solution Bag

    Chapter 7: Reinfusion Reinfusion with Rinse Solution Bag If the 5008 ONLINEplus™ hemodialysis system cannot be operated without rinse solution, rinse or infusion solutions provided in NaCl bags may be used instead. 7.2.1 Disconnecting the Patient — Double-Needle Dialysis with Rinse Solution Bag...
  • Page 142 Close the shunt door. ® 7.2.3 bibag Emptying the ® Emptying of the bibag is started automatically after emptying of the dialyzer. (Operator Setup setting) Touch the DIALYSATE MENU menu button. Touch the Empty bags field. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 143 Discard the extracorporeal blood circuit after the treatment. Observe the regulations for the handling of potentially contaminated materials. Remove the blood lines. Close the doors. Caution It is imperative to disinfect the system after each treatment. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 144 Chapter 7: Reinfusion Fresenius Medical Care 5008 OP 5/09.06...

  • Page 145: Single-Needle (Option) Reinfusion Using Onlineplus

    Single-Needle (Option) Reinfusion with Rinse Solution Bag The procedures for end of treatment after achieving the UF goal or aborting treatment with reinfusion program are described in the chapters mentioned below (see chapter 7.2 , page 7-5). Fresenius Medical Care 5008 OP 5/09.06...
  • Page 146 Chapter 7: Reinfusion 7-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 147 Fold-Out Sheet Cleaning Fresenius Medical Care 5008 OP 5/09.06...
  • Page 148 Connecting the disinfectant container CLEANING SCREEN Program run graphic (e.g. Diasteril)

  • Page 149: Cleaning

    Safe function can therefore not be ensured and the ® manufacturer shall no longer have any liability. (see DIASAFE plus package insert.) Fresenius Medical Care 5008 OP 5/09.06...

  • Page 150: Connecting The Disinfectant Container

    ® Connect the disinfectant container (e.g.: Citrosteril container). ® ® Place the Citrosteril container (1) on the rack. Connect the Citrosteril container to the yellow port (2) on the left. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 151: Starting A Cleaning / Disinfection Program

    While the cleaning programs are in progress, it is not permitted to connect the dialysate lines to the dialyzer. Depending on the settings in the Operator setup, it is also possible to start the cleaning programs automatically. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 152: Aborting A Cleaning / Disinfection Program

    "Yes", the system will signal the end of a cleaning program or a disinfection program for approx. 30 seconds as follows: Message: Cleaning program successfully completed! – OK Audible info The SELECTION SCREEN will then be displayed. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 153: Checking For Residual Disinfectant

    Touch the Monitor Symbol button for approx. 3 seconds. (The screen will be "frozen".) After cleaning the screen: Touch the Monitor Symbol button for approx. 1 second. (Normal screen operation is restored.) The screen will be "unfrozen" if a warning or an alarm occurs. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 154: Turning The Hemodialysis System Off

    – Auto Off Time after which the machine will turn itself off (programmable in the Technician's Setup). If a time has been defined for Auto Off, the hemodialysis system will turn itself off automatically after the programmed time. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 155 Fold-Out Sheet Alarm processing Fresenius Medical Care 5008 OP 5/09.06...
  • Page 156 Informational message Manually opening the arterial pressure measurement unit Warning message Alarm message (Info window at the top opened) Flipping the handle outward...

  • Page 157: Alarm Processing

    Help can be displayed directly by touching the ? button in the window. The associated Information window will be opened automatically. If the problem cannot be corrected, call the service. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 158: Air Detected Below The Venous Bubble Catcher

    During the air removal procedure the blood pump delivery rate is automatically reduced to 50 ml/min. The blood pump delivery rate can be increased as required to improve the separation of air and micro bubbles. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 159: Air Removal

    Alarm message Info window (can be displayed by touching the ? button) Follow the instructions. Touch the Confirm button. Alarm message Safety prompt After the instructions have been carried out, Touch the Confirm button. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 160 ? button) The next message will automatically be displayed if the venous pressure is < 100 mmHg. Informational message Info window (can be displayed by touching the ? button) Touch the Start button. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 161 Touch the Yes button if all air has been removed from the venous tubing system. Touch the No button if air is still present in the venous tubing system. Automatically the previous info message is then displayed. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 162 Info window (can be displayed by touching the ? button) Follow the instructions. Touch the Continue button. The blood pump will start with the delivery rate displayed. Check the delivery rate and change, if necessary. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 163: Micro Bubbles Detected Below The Venous Bubble Catcher

    During the air removal procedure the blood pump delivery rate is automatically reduced to 50 ml/min. The blood pump delivery rate can be increased as required to improve the separation of air and micro bubbles. Fresenius Medical Care 5008 OP 5/09.06...
  • Page 164 Info window (can be displayed by touching the ? button) Touch the Continue button and observe the following section "Overriding the Micro bubbles alarm message". Touch the Confirm button and observe the following section "Micro bubbles removal procedure". Fresenius Medical Care 5008 OP 5/09.06...
  • Page 165 (see chapter 9.2 , page 9-2). Micro bubbles will be displayed in the Message button field. The alarm message will be overridden for the time set in the Technician's Setup. Fresenius Medical Care 5008 OP 5/09.06...

  • Page 166: Micro Bubbles Removal

    Info window (can be displayed by touching the ? button) Follow the instructions. Touch the Confirm button. Then follow the further instructions. Alarm message Safety prompt After the instructions have been carried out, Touch the Confirm button. 9-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 167 ? button) The next message will automatically be displayed if the venous pressure is < 100 mmHg. Informational message Info window (can be displayed by touching the ? button) Touch the Start button. Fresenius Medical Care 5008 OP 5/09.06 9-11...
  • Page 168 Touch the Yes button if all air has been removed from the venous tubing system. Touch the No button if air is still present in the venous tubing system. Automatically the previous info message is then displayed. 9-12 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 169 Info window (can be displayed by touching the ? button) Follow the instructions. Touch the Continue button. The blood pump will start with the delivery rate displayed. Check the delivery rate and change, if necessary. Fresenius Medical Care 5008 OP 5/09.06 9-13...

  • Page 170: Management Of Alarm Limits

    Chapter 9: Alarm Processing Management of Alarm Limits The 5008 hemodialysis system is provided with an automatic management of alarm limits. It allows avoiding false alarms, which might for example be caused by a movement of the patient. The preset asymmetric venous standard alarm limits lead to a sensitive reaction in case of a venous pressure alarm.

  • Page 171: Conductivity

    Power failure – System is battery-operated. Acknowledge the audible alarm. (UF pump stops, substituate pump stops, dialysate flow off.) After power return, the message disappears. (Dialysate alarms will be suppressed for further 2 minutes approximately.) Fresenius Medical Care 5008 OP 5/09.06 9-15...
  • Page 172 Visually check the line for air. Manually return the blood. Remove the venous patient connection after manual blood return. Close the clamps on the blood lines. Manually remove the blood lines. Manually open the arterial pressure measurement unit. 9-16 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 173: Screen Failure

    (blood pump, substituate pump, optionally Single-Needle pump) Reinfusion with rinse solution. All monitoring systems are active. Disconnect the arterial patient connection and connect it to the rinse solution bag. Touch the Blood system Start button (green). Fresenius Medical Care 5008 OP 5/09.06 9-17...
  • Page 174 The alarm limits will be set around the actual values. Perform a reinfusion. Remove the venous patient connection after blood return. Close the clamps on the blood lines. Manually remove the blood lines. Manually open the arterial pressure measurement unit. 9-18 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 175 Fold-Out Sheet 10 Other Functions Fresenius Medical Care 5008 OP 5/09.06...
  • Page 176 SYSTEM SCREEN Collecting a sample SETUP SCREEN (Operator setup) BLOOD SYSTEM SCREEN ® Changing the DIASAFE plus Cleaning the dialysate particle filter...

  • Page 177: Other Functions

    (not adjustable) Loudness 1 to 9 – Graphic time scale Auto – – Auto (The last time 10 min segments of the 20 min respective 30 min treatment will be displayed.) 10 h Fresenius Medical Care 5008 OP 5/09.06 10-1...

  • Page 178: Operator Setup

    (6.4 mm) Delivery rates Prime 100 ml/min 30 to 600 ml/min 10 ml/min – Precirculation 100 ml/min 30 to 600 ml/min 10 ml/min – Reinfuse 100 ml/min 30 to 300 ml/min 10 ml/min – 10-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 179: Anticoagulation

    (Define syringe types) Bolus 5.0 ml/h 1.0 to 20.0 ml/h 0.1 ml/h – 1000 I.U./h 0 to 15 000 I.U./h 10 I.U./h – Auto bolus (No) (–) (–) (No) (Currently not (Yes) adjustable.) Fresenius Medical Care 5008 OP 5/09.06 10-3...
  • Page 180 10.00 to 30.00 ml 5 ml – Syringe total length (3) – 30.00 to 5 mm – 95.00 mm Total length (i.e. rem. – 5.00 to 30.00 mm 5 mm – length) (4) 10-4 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 181 – – Factor 1.0 to 2.0 – Temperature 36.5 °C 34 °C to 39 °C 0.5 °C – Bags Empty bibag Automatic – – Automatic, (If optical detector does not sense blood.) Manual Fresenius Medical Care 5008 OP 5/09.06 10-5...
  • Page 182 AC-F 216, AC-F 411, AC-F 412/1, AC-F 413, AC-F 413/1, AC-F 419, AC-F 419/2, AC-F 016 AF 10, AF 11, AF 12, AF 13, AF 14, AF 15, AF 70, AF 71, AF 72, AF 73, AF 74 10-6 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 183 If the B concentrate contains additional saline, the value for Na(B) equals the total of the final concentration of this saline in the ready-to-use dialysate, the HCO (bicarbonate) and the acid (A). If a zero figures under Na(B), it is assumed to be pure bicarbonate concentrate. Fresenius Medical Care 5008 OP 5/09.06 10-7...
  • Page 184 125 mmol/l ≤ prescribed Na ≤ 155 mmol/l Prescr. Bic: Concentration of the prescription ± 8 mmol/l and: 20 mmol/l ≤ prescribed bicarbonate ≤ 40 mmol/l and: 12.8 mS/cm ≤ expected conductivity ≤ 15.7 mS/cm 10-8 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 185 Electrolytes 1 mmol/l 1/100 mmol/l 0.00 5.00 1/1000 mmol/l 0.00 2.500 1/100 mmol/l 0.20 1.00 1/100 mmol/l 80.00 1/10 mmol/l 1/100 mmol/l 30.00 40.00 Other ingredients Glucose Component ingredients Acid (A) Na(B) Fresenius Medical Care 5008 OP 5/09.06 10-9...
  • Page 186 Acetate and acid input ≤ 10.00 1/100 mmol/l 0.00 10.00 Other ingredients Glucose Component ingredients Acid (A) 1/100 mmol/l 1.50 in most cases = acetate Na(B) 1/10 mmol/l = bicarbonate = bicarbonate + + acid 30.0 10-10 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 187 (bicarbonate) 32.00 mmol/l (acetate) 3.00 mmol/l Other ingredients Glucose 2.00 Component ingredients Acid (A) mmol/l (acetate) Na(B) mmol/l (bicarbonate) Na in the bicarbonate It is possible to verify data entry as follows: Fresenius Medical Care 5008 OP 5/09.06 10-11...
  • Page 188 NaCl 210.68 g/l / 35 (mixing ratio) = 6.019 g/l 6.019 g/l / 58.443 (atomic weight NaCl) = 0.103 mol/l = 103 mmol/l Entry Na = 103 mmol/l (Na of NaCl) + 35 mmol/l (Na of bicarbonate) = 138 mmol/l (entry Na+) 10-12 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 189 3500 ml/h 3010 to 4000 ml/h 10 ml/h – Current treatment data (Displays the current treatment data during the treatment.) Max. UF rate – – – – Max. profile rate – – – – Fresenius Medical Care 5008 OP 5/09.06 10-13...

  • Page 190: Kinking Warning

    – (= WET on/off) User interface Sub-item Default value Value range Resolution Selectable options Screen saver (= SCREEN SAVER) Screen saver – – Delay 0:05 h:min 0:01 to 1:00 h:min 0:01 h:min – 10-14 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 191: Define Options

    (If the BPM option is available, a maximum of 3 options may be created.) Options can be added only if the particular option is available. Option HEPARIN – – HEPARIN ONLINE CIRCULATE SINGLE-NEEDLE menu ONLINE Fresenius Medical Care 5008 OP 5/09.06 10-15...
  • Page 192 Sub rate Sub pump I/O From the – – – Effective blood SINGLE-NEEDLE flow menu Stroke vol. Lower SN pressure Upper SN pressure Ratio (approx.) From the BTM menu – – – Recirculation I/O 10-16 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 193 – after treatment Audible info – – Auto Off 10 min – – 10 min 30 min 60 min Immediately Disinfection note – – Message: The last disinfection was performed XX hours/days ago.) Fresenius Medical Care 5008 OP 5/09.06 10-17...

  • Page 194: Single Programs

    Chapter 10: Other Functions Auto On Following completion of the last disinfection of the 5008 hemodialysis system of the day it is possible to connect a ® bibag (72 hours is the maximum time allowed prior to the treatment). If you wish to use this possibility, the following actions must be performed.

  • Page 195: Emergency

    30 ml – Bolus rate 200 ml/min 50 to 250 ml/min 10 ml/min – Emergency bolus – – (Preset: bolus = 240 ml, bolus rate = blood flow before emergency – 50 ml/min) Fresenius Medical Care 5008 OP 5/09.06 10-19...
  • Page 196 – Message: Saving data to card. Leave card inserted! – Remove the patient card following the message. First name – – – – Surname – – – – Database ID – – – – Date of birth – – – – 10-20 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 197: Auto-Sub

    Substitution Auto-sub – – Hemoconcentration Monitoring – – (Intended to avoid excessive hemoconcentration in the dialyzer due to a too high ultrafiltration.) – Dialyzer class FX HighFlux – – FX HighFlux F HighFlux Fresenius Medical Care 5008 OP 5/09.06 10-21...

  • Page 198: Kt/V Warning

    0.60 to 1.40 0.05 – OCM (can only be selected if OCM exists.) Sub-item Default value Value range Resolution Selectable options OCM start Automatic – – Automatic Manual Kt/V warning – – (see OCM description) 10-22 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 199: Miscellaneous

    Miscellaneous Sub-item Default value Value range Resolution Selectable options Installation place Installation place of the 5008 hemodialysis system may be entered here (e.g. name (Displayed in submenu of the hospital). "Status", "Device info") Pressure holding test, – – dialyzer couplings Fresenius Medical Care 5008 OP 5/09.06...
  • Page 200 0 to xxxx ml 50 ml – (Limitation to the value set in the Technician's setup) Negative deviation 0 ml 0 to xxxx ml 50 ml – (Limitation to the value set in the Technician's setup) 10-24 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 201: Room Temperature

    Max. dialysate 38.0 °C 37.0 to 38.0 °C 0.5 °C – temperature Room temperature Room temperature 20.0 °C 15.0 to 35.0 °C 1.0 °C – (Is not measured, but has to be set.) Fresenius Medical Care 5008 OP 5/09.06 10-25...

  • Page 202: Emergency Button

    The drain program is in progress. Message: The bibag is empty and it can now be removed or – Empty bibag Repeat ® Remove the bibag ® If a new bibag is to be used: 10-26 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 203: Changing The Diasafe ® Plus

    To change the filter it is imperative to use the filter change program. Note ® The change of the DIASAFE plus must be entered in the Medical Device Register (date, batch number). Make sure that no patient is connected to the system. CLEANING SCREEN Fresenius Medical Care 5008 OP 5/09.06 10-27...

  • Page 204: Cleaning The Dialysate Particle Filter

    Release the locking pin (5). The key will automatically close the valve. 10.8 Removing Lines During Preparation During Preparation, it is possible to remove the desired blood line part via the BLOOD SYSTEM MENU. 10-28 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 205: Removing Lines During Treatment

    Message: When changing the SafeLine 1. Disconnect the SafeLine from the blood line 2. Remove the connector from the substituate port. 3. Close the port 4. Close the doors – OK – Abort Touch the OK button. Fresenius Medical Care 5008 OP 5/09.06 10-29...

  • Page 206: Circulation

    For a description of the further procedure refer to chapter 7 Reinfusion. The treatment must be restarted as described in chapter 5. 10.10 Circulation The Circulation function allows to disconnect the patient from the 5008 hemodialysis system for a short time during the treatment. 10-30...

  • Page 207: Setting The Level In The Venous Bubble Catcher

    Touch the Level Set button. Level Set button (The function is available only if the rinse procedure using the rinse volume has been completed.) The level is automatically lowered and then raised to the correct position. Fresenius Medical Care 5008 OP 5/09.06 10-31...

  • Page 208: Single-Needle Click-Clack

    Connect both the arterial and the venous patient line to the same vascular access. Touch the Start button. Touch the TREATMENT menu button to return to the TREATMENT SCREEN. Aborting Single-Needle Click-Clack In the SINGLE-NEEDLE menu Touch the Click-Clack I/O button. 10-32 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 209 Message: Connect the arterial and the venous patient line to the respective vascular access. – Double-Needle Start – Abort Connect the arterial and the venous patient line to the respective vascular access. Touch the Start button. Fresenius Medical Care 5008 OP 5/09.06 10-33...
  • Page 210 Chapter 10: Other Functions 10-34 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 211: System Description

    Type identification, serial number Power requirements Protection against ingress of liquids: drip-proof Caution, consult accompanying documents Equipment code (EC: Equipment Code) Degree of protection against electric shock: Type B CE mark Fresenius Medical Care 5008 OP 5/09.06 11-1...

  • Page 212: Electrical Safety

    +18 V ± 3 %, 14 A short-circuit proof 480 W total power output Battery Lead-acid battery (maintenance-free) 24 V, 7 Ah 11.1.5 Fuses Main power switch 2 x G 16 A (miniature circuit-breaker) rear of power supply unit 11-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 213 Guidance and manufacturer’s declaration – electromagnetic emissions The 5008 hemodialysis system is intended for use in the electromagnetic environment specified below. The customer or the user of the 5008 hemodialysis system should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 214 If the measured field strength in the location in which the 5008 hemodialysis system is used exceeds the applicable RF compliance level above, the 5008 hemodialysis system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 5008 hemodialysis system.

  • Page 215: Operating Conditions

    Chapter 11: System Description The 5008 hemodialysis system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 5008 hemodialysis system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 5008 hemodialysis system as recommended below, according to the maximum output power of the communications equipment.

  • Page 216: Audible Alarm Suppression

    11.1.9 Override Conditions When overriding a safety system the responsibility for the patient’s safety rests with the operator of the machine. Audible alarm suppression Mute alarm time: maximum 2 minutes (adjustable in the Operator setup) 11-6 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 217: Alarm Override

    Exceptional procedure in case of problems with the vascular access during Double-Needle treatment. Circulation (during the The Circulation function allows to disconnect the patient from the 5008 treatment) hemodialysis system for a short time during the treatment. During circulation the hemodialysis system 5008 shows the following behavior: –...

  • Page 218: Blood Leak Detector

    Pump volume accuracy: ±1 % (for P > –500 mbar) The UF rate/effective blood flow ratio is being monitored during the treatment. If a discrepancy occurs a warning will be displayed after approx. 10 seconds. Pressure holding test Event-controlled 11-8 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 219: Autoflow

    Desired values: 100 to 1000 ml/min Measurement by means of time pulse monitoring and balancing chamber volume AutoFlow: The AutoFlow function automatically regulates the dialysate flow, depending on the dialyzer type and blood flow. Fresenius Medical Care 5008 OP 5/09.06 11-9...
  • Page 220 1+24. ® The disinfectant (Sporotal 100) is diluted with purified water in the dialysis system at a ratio of 1+34. 11-10 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 221: Flow Alarm

    OD dark (blood in the tubing system). Air bubble detector Method: Ultrasonic transmission measurement on the line Sensitivity: – Air bubbles: Bubble volume ≥ 20 µl – Blood foam (air-blood mixture) – Micro bubbles Fresenius Medical Care 5008 OP 5/09.06 11-11...

  • Page 222: Audible Alarm

    Blood foam Micro bubbles The specified data refer to the most unfavorable case with a BP rate of 0 to 600 ml/min when using the blood lines approved for the 5008 hemodialysis system. Heparin pump Delivery rate: 0.5 to 10 ml/h Resolution: 0.1 ml/h...

  • Page 223: Auto-Single-Needle

    Delivery rate of the Single-Needle pump 11.1.17 BPM (Option) Blood pressure Display range – Systole: 30 mmHg to 280 mmHg – Diastole: 10 mmHg to 240 mmHg – MAP: 20 mmHg to 255 mmHg Fresenius Medical Care 5008 OP 5/09.06 11-13...

  • Page 224: Body Temperature Control

    Maximum dialysate temperature range used by the BTM: (adjustable in the Operator setup) 35.0 °C to 37.0 °C, 37.5 °C or 38.0 °C 11.1.19 BVM (Option) The following accuracy information is valid after successful calibration of the cuvette during Preparation. 11-14 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 225 The responsible organization of the network is responsible for the protection of the not encrypted, transferred data. The data transfer of alarm states via the network must not be used as an external alarm alert (staff call). Fresenius Medical Care 5008 OP 5/09.06 11-15...

  • Page 226: Storage

    Apply the brake Close the vent tubing. Lift the machine for transportation. When lifting the system never hold it by the IV pole, the handle or one of the system components (e.g. EBM doors). 11-16 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 227: Environmental Compatibility And Recycling

    Materials shown on a grey background color come into contact with purified water, dialysate and dialysate concentrate. Plastics and cast resins Abbreviation Material EPDM Ethylene-propylene terpolymer FPM (FKM) Fluoro rubber Perfluoroalkox copolymer PAEK Polyaryletherketone PPSU Polyphenylene sulphone PVDF Polyvinylidenefluoride PTFE Polytetrafluor ethylene Fresenius Medical Care 5008 OP 5/09.06 11-17...
  • Page 228 PU foam Polyurethane foam polystyrene Metals/glass/graphite/ ceramic Abbreviation Material Glass Glass Graphite Graphite Ceramics Ceramics Special steel Special steel Titanium Steel Iron Aluminium and aluminum alloys CuZn39 Brass Magnet Samarium-cobalt magnet Magnet NdFe magnet 11-18 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 229 Copper beryllium Cables Copper Teflon Electronics P.C.B. base material Epoxy fiberglass Ferrite cores Lithium batteries Lead-acid batteries Auxiliary materials Abbreviation Material Adhesives Loctite 3321 UHU Plus Endfest Scotchweld DP 499 Insulating material Polyethylene Fresenius Medical Care 5008 OP 5/09.06 11-19...
  • Page 230 Screening lacquer – copper conductive lacquer PUR structural lacquer Grease Unisilicone Materials used – consumables Blood lines Abbreviation Material Medical plasticized PVC Polycarbonate Medical unplasticized polyvinyl chloride Acrylonitrite-butadiene-styrene Polyamide Polyethylene bibag Abbreviation Material Polyamide Polyethylene 11-20 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 231 Chapter 11: System Description Fresenius Medical Care 5008 OP 5/09.06 11-21...

  • Page 232: System Description

    Arterial occlusion clamp Heparin pump Arterial pressure measurement unit Blood pump Dialyzer Venous pressure port External hydrophobic filter Venous pressure sensor Valve Orifice Compressor Level detector Optical detector Air bubble detector (ABD) Venous occlusion clamp 11-22 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 233 – The substituate pump will stop (only with ONLINEplus™). – the venous occlusion clamp is closed. – A visual and an audible alarm will be given. – Ultrafiltration will be stopped. – The heparin pump is stopped. Fresenius Medical Care 5008 OP 5/09.06 11-23...
  • Page 234 Rinse valve 1 Rinse port Rinse valve 2 Substituate pump SafeLine™Connector (to 13 Predilution or to 14 Postdilution) Connector predilution Connector postdilution BTM (option) Arterial measuring head Venous measuring head BVM (option) BVM measuring head 11-24 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 235 The BTM arterial and venous measuring heads are designed to measure the temperature of the arterial and venous blood temperature at this position. BVM (option) The BVM measuring head is designed to measure the relative blood volume of the patient. Fresenius Medical Care 5008 OP 5/09.06 11-25...

  • Page 236: Flow Diagram

    In the balancing chamber, the volumes to and from the dialyzer are volumetrically balanced. The fresh dialysate then enters the dialyzer ® having passed through the DIASAFE plus and the dialyzer valve. 11-26 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 237 OCM logo ® is a registered trademark. Intended use Fields of application The OCM allows determination of the average effective urea clearance (K), the dialysis dose Kt/V and the plasma sodium concentration during dialysis. Fresenius Medical Care 5008 OP 5/09.06 11-27...
  • Page 238 (High-Flux) to the closed dialysate circuit of the dialysis system, the volume balance remains neutral. Fluid is therefore removed from the patient by the UF pump only. 11-28 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 239 As soon as the pressure in the internal compliance chamber reduces below the lower set limit, the process described above restarts. Fresenius Medical Care 5008 OP 5/09.06 11-29...
  • Page 240 – Use of a heart lung machine – Complications in the peripheral circuit – Convulsions – Spasms – Tremors – Tachycardia The attending physician is responsible for deciding on whether or not the BPM should be used. 11-30 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 241: Recirculation

    The curve is determined by specifying the time-related change of the body temperature (in °C/h). The body temperature is determined by the measurement values of the two (art./ven.) temperature-compensated measuring heads and the measurement values resulting from the recirculation measurements. Fresenius Medical Care 5008 OP 5/09.06 11-31...
  • Page 242 BVM rate (UF rate preset by the BVM) Crit. RBV BVM-Rate = 2 x remaining UF volume / remaining treatment time, limited by max. BVM rate Control range, UFR depending on current RBV UFR = 0 11-32 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 243 The BVM rate may be limited depending on the blood pump rate and the measured hematocrit, to avoid a too important hemoconcentration in the dialyzer. Fresenius Medical Care 5008 OP 5/09.06 11-33...

  • Page 244: Blood Lines (Description)

    Arterial injection site/collection site Arterial pressure dome Line guide Pump segment Dialyzer connector (arterial blood line) Dialyzer Dialyzer connector (venous blood line) Venous injection site/collection site Connection, venous pressure line Venous pressure line 11-34 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 245: Connector Postdilution

    Venous bubble catcher Venous blood line Venous patient connection Heparin line Heparin syringe Connector predilution Connector postdilution Substituate connector (SafeLine™) SafeLine™ SafeLine™ line guide SafeLine™ pump segment Connector pre/postdilution (SafeLine™) Recirculating adapter (SafeLine™) Rinse connector Fresenius Medical Care 5008 OP 5/09.06 11-35...
  • Page 246 Dialyzer Dialyzer connector (venous blood line) Venous injection site/collection site Connection, venous pressure line Venous pressure line Venous bubble catcher Venous blood line Venous patient connection Heparin line Heparin syringe Rinse solution bag 11-36 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 247 Chapter 11: System Description Prime collection bag Fresenius Medical Care 5008 OP 5/09.06 11-37...

  • Page 248: Blood Lines With Onlineplus Single-Needle

    Arterial pressure dome Line guide Pump segment Dialyzer connector (arterial blood line) Dialyzer Dialyzer connector (venous blood line) Venous injection site/collection site Connection, venous pressure line Venous pressure line Venous bubble catcher Venous blood line 11-38 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 249 SafeLine™ line guide SafeLine™ pump segment Connector pre/postdilution (SafeLine™) Recirculating adapter (SafeLine™) Rinse connector Arterial blood line (Single-Needle part) SN line guide SN pump segment SN chamber SN pressure line Connector, SN pressure line Fresenius Medical Care 5008 OP 5/09.06 11-39...

  • Page 250: Blood Lines With Single Needle With Rinse Solution Bags

    Pump segment Dialyzer connector (arterial blood line) Dialyzer Dialyzer connector (venous blood line) Venous injection site/collection site Connection, venous pressure line Venous pressure line Venous bubble catcher Venous blood line Venous patient connection 11-40 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 251 Chapter 11: System Description Heparin line Heparin syringe Rinse solution bag Prime collection bag Arterial blood line (Single-Needle part) SN line guide SN pump segment SN chamber SN pressure line Connector, SN pressure line Fresenius Medical Care 5008 OP 5/09.06 11-41...

  • Page 252: Initial Start-Up

    The initial start-up must be performed by the Technical Service of Fresenius Medical Care or a person authorized by them! In case of a first installation of the dialysis system, observe the Specifications.
  • Page 253 (B / BF / CF) Housing leakage currents of all types Via the blood 10 times higher than and the dialysate "CF" patient the patient is leakage current electrically connected to the earth potential. Fresenius Medical Care 5008 OP 5/09.06 11-43...
  • Page 254 (e.g. in Germany VDE 0753, part 4). For further information refer to the Specifications. Each system must be provided with its own free fall air gap. 11-44 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 255 Central delivery systems for concentrate or dialysate must meet high hygienic standards and demand regular inspection. Fresenius Medical Care 5008 OP 5/09.06 11-45...
  • Page 256 Chapter 11: System Description 11.7.5 Performing the Initial Start-Up For initial start-up it is imperative to follow the start-up report. A current start-up report is supplied with each hemodialysis system. 11-46 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 257: Technical Safety Checks And Technical Measurement Checks

    Numbers not listed are not part of the TSC/TMC. These are part of the maintenance procedures. Please refer to the Service Manual for further explanatory information on the Technical Safety Checks, the Technical Measurement Checks and the Maintenance Procedures. Fresenius Medical Care 5008 OP 5/09.06 11-47...
  • Page 258 – System / ® (If the bibag option is used, the test has to be performed in ref. ® conjunction with a bibag Difference between system CD / ref. CD: ≤±0.2 mS/cm ____/____ 11-48 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 259 In Germany according to DIN VDE 0751-1, edition 10/2001. In other countries, observe the local regulations! Visual inspections performed according to item 1. Protective earth resistance measured. Max. 0.3 Ω (with power cable) ______ Ω Fresenius Medical Care 5008 OP 5/09.06 11-49...
  • Page 260 Final inspection and testing T1 test performed with all options. Disinfection performed. Test equipment used: Temperature, conductivity, pressure (type, serial number): ________________________________________________________________________________________ Protective earth resistance, leakage current (type, serial number): ________________________________________________________________________________________ Comments: Date: Signature: Stamp: 11-50 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 261 Chapter 11: System Description The system has been released for its intended use. (Attach test badge.) Next inspection date: Comments: Date: Signature: Stamp: Fresenius Medical Care 5008 OP 5/09.06 11-51...

  • Page 262: Definitions And Terms

    Pump head The pump head consists of the pump rotor and the pump stator. Pump rotor Driven part of the pump head. Pump line segment Line segment which is inserted in the pump head. 11-52 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 263: Abbreviations

    Balancing chamber Bicarbonate Blood pump Blood Pressure Monitor Blood Temperature Monitor Blood Volume Monitor Conductivity Central delivery system Direct current Extracorporeal Blood Module Electromagnetic compatibility Fig. Figure (diagram) Hemodialysis Hemodiafiltration Hemofiltration Air Detector Fresenius Medical Care 5008 OP 5/09.06 11-53...

  • Page 264: Symbols

    Degree of protection against electric shock: Type B Degree of protection against electric shock: Defibrillator-protected applied part of type CF, Alternating current Protective conductor terminal Ground terminal Equipotentiality Dangerous electrical voltage Risk of caustic burning 11-54 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 265: Consumables Symbols

    Identification of electric and electronic devices 11.12 Consumables Symbols Refer to the Operating Instructions Do not re-use Use by Batch code Date of manufacture Quantity Catalogue number Temperature limitation +30°C +5°C Pump segment diameter Fresenius Medical Care 5008 OP 5/09.06 11-55...
  • Page 266 Chapter 11: System Description Sterile. Sterilised using ethylene oxide STERILE EO Sterile. Sterilised using irradiation STERILE R Sterile. Sterilised using steam or dry heat STERILE 11-56 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 267: Consumables

    ® Fresenius Medical Care Helixone dialyzers of the FX class (low-flux and high flux) e.g.: FX8 / FX80 12.3 Blood Lines Fresenius Medical Care ONLINE Priming/HDF blood lines for the 5008 hemodialysis system Fresenius Medical Care 5008 OP 5/09.06 12-1...

  • Page 268: Disposable Syringes

    503 032 1 Luer lock connector, latex-free plug 12.5 Hemodialysis Concentrates Fresenius Medical Care solutions for bicarbonate dialysis Acid bicarbonate hemodialysis concentrate 1+44 AC-F (45-fold) Acid bicarbonate hemodialysis concentrate 1+34 SK-F (35-fold) for mixing with basic sodium hydrogen carbonate concentrate 8.4 % ®...

  • Page 269: Surface Disinfection / Surface Cleaning

    Active substance base: citric acid hydrate Active substance concentration: approx. 0.8 % (diluted) ® Fresenius Puristeril 508 551 1 5 kg container Active substance base: peracetic acid Active substance concentration: approx. 0.15 % (diluted) Fresenius Medical Care 5008 OP 5/09.06 12-3...

  • Page 270: Disinfectant Indicators

    Information ® pH test strips 628 816 3 Indicator for Diasteril Potassium-iodide-starch paper 508 521 3 6 x 100 strips ® Indicator for Sporotal ® Indicator for Puristeril 340 and ® Puristeril plus 12-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 271: Certificates

    Chapter 13: Certificates 13 Certificates 13.1 EC Certificate Fresenius Medical Care 5008 OP 5/09.06 13-1...
  • Page 272 Chapter 13: Certificates 13-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 273 Chapter 13: Certificates Fresenius Medical Care 5008 OP 5/09.06 13-3...
  • Page 274 Chapter 13: Certificates 13-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 275: Appendix

    Dr. B. Canaud, Division of Nephrology, Lapeyronie University Hospital, 555, Route de Ganges, 34059 Montpellier, France. Blood Temperature Monitor (BTM) “Fresenius Publikation” (EDTNA-Journal 1992) with further literature. Blood Volume Monitor (BVM) “Fresenius Publikation” (BVM-Blutvolumenmonitor) with further literature. Fresenius Medical Care 5008 OP 5/09.06 14-1...
  • Page 276 Chapter 14: Appendix 14-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 277 Fold-Out Sheet 15 OCM Fresenius Medical Care 5008 OP 5/09.06...
  • Page 278 OCM SCREEN OCM diagram...

  • Page 279: Option Ocm (Online Clearance Monitoring)

    Percentage of the volume of the red blood cells in the total blood. Clearance The clearance (K) (in ml/min) is the average effective urea clearance. which describes the blood flow volume that is completely cleared of urea. Fresenius Medical Care 5008 OP 5/09.06 15-1...

  • Page 280: Menu Overview

    Touch the Goal Kt/V field or entering the Goal Kt/V. Interval Displays the measurement interval. Touch the Interval field for entering the measurement interval. Displays the hematocrit. Touch the Hct field for entering the hematocrit. 15-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 281: Checking/Setting The Ocm Parameters

    Watson. Alternatively V (urea) can be determined in the laboratory from blood samples. The PC program DC-Tool distributed by Fresenius Medical Care is available for this purpose. The Hct value determined from a blood sample prior to the treatment must be entered in the Hct field.

  • Page 282: Stability Criteria

    In the OCM menu Touch the OCM I/O button. The OCM can be turned off at any time. The OCM will also be turned off if the stability criteria are not fulfilled anymore. 15-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 283: Alarm Processing

    A warning will be displayed if the OCM detects after approx. 90 minutes of treatment that the Kt/V goal is expected to be more than 15 % below the Kt/V goal which has been entered. This warning can be deactivated in the Operator setup. Fresenius Medical Care 5008 OP 5/09.06 15-5...
  • Page 284 Chapter 15: Option OCM (Online Clearance Monitoring) 15-6 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 285 Fold-Out Sheet 16 ONLINEplus™ Fresenius Medical Care 5008 OP 5/09.06...
  • Page 286 ONLINE SCREEN...

  • Page 287: Onlineplus

    Chapter 16: ONLINEplus™ 16 ONLINEplus™ Fresenius Medical Care 5008 OP 5/09.06 16-1...

  • Page 288: Menu Overview

    Sub volume Displays the substitution volume. Sub pump I/O Button for starting/stopping the substituate pump. Bolus Displays the bolus volume. Bolus rate Displays the bolus rate. Cum. Bolus Displays the cumulated bolus volume. 16-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 289: Preparation/Treatment/Reinfusion

    The treatment using the ONLINEplus™ module is described in the following chapters: – Preparation using ONLINEplus™ (see chapter 5.1 , page 5-1) – Preparation using ONLINEplus™ (see chapter 6.1 , page 6-1) – Reinfusion using ONLINEplus™ (see chapter 7.1 , page 7-1) Fresenius Medical Care 5008 OP 5/09.06 16-3...
  • Page 290 Chapter 16: ONLINEplus™ 16-4 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 291 Fold-Out Sheet 17 Option SN Fresenius Medical Care 5008 OP 5/09.06...
  • Page 292 SINGLE-NEEDLE SCREEN...

  • Page 293: Option Sn (Single-Needle)

    Chapter 17: Option SN (Single-Needle) 17 Option SN (Single-Needle) Fresenius Medical Care 5008 OP 5/09.06 17-1...

  • Page 294: Menu Overview

    Displays the SN rate. Rocker switch for increasing + / reducing – the Single-Needle flow. Stroke vol. Displays the effective blood flow. Effective blood flow Displays the Single-Needle stroke volume. SINGLE-NEEDLE SINGLE-NEEDLE menu button 17-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 295: Preparation/Treatment/Reinfusion

    – Single-Needle (Option) treatment (prepared with rinse solution bag) (see chapter 6.4 , page 6-17) – Single-Needle (option) reinfusion using ONLINEplus™ (see chapter 7.3 , page 7-9) – Single-Needle (option) reinfusion with rinse solution bag (see chapter 7.4 , page 7-9) Fresenius Medical Care 5008 OP 5/09.06 17-3...
  • Page 296 Chapter 17: Option SN (Single-Needle) 17-4 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 297 Fold-Out Sheet 18 Option BPM Fresenius Medical Care 5008 OP 5/09.06...
  • Page 298 Applying the blood pressure cuff BPM, graphic (SYS/DIA/PULSE) BPM SCREEN BPM (MAP), graphic (MAP/PULSE) BPM SCREEN (Interval) BPM history BPM SCREEN (Quick)

  • Page 299: Option Bpm (Blood Pressure Monitoring)

    For an overview of blood pressure cuffs, please refer to chapter 12 Consumables. The blood pressure cuff may only be connected to the 5008 hemodialysis system. It is not permitted to use the BPM for measurements on neonates or infants.

  • Page 300: Menu Overview

    The actual value is displayed as a numerical value and as a bar. The alarm window is displayed in block representation, according to the window size. Touch the PULSE field for setting the alarm limits. 18-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 301: Applying The Blood Pressure Cuff

    The blood pressure cuff must be correctly aligned and must have a good contact to the skin. The marking must be positioned directly over the artery. 18.5 Checking/Setting the Inflation Pressure/Alarm Limits Caution Do not select an inflation pressure that is unnecessarily high. Fresenius Medical Care 5008 OP 5/09.06 18-3...

  • Page 302: Starting The Blood Pressure Measurement

    18.7 Blood Pressure Measurement Completed Blood pressure display grey. (Yellow in case of interval.) The pressure values (SYS/DIA) are displayed. (Partial results will also be displayed.) Check the blood pressure parameters for plausibility and patient allocation. 18-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 303: Aborting The Blood Pressure Measurement

    – BPM (MAP), graphic (contains MAP and PULSE) – BPM history for up to 60 measurements (contains SYS, DIA, MAP, and PULSE) Use the button to scroll through the BPM history, if required. Fresenius Medical Care 5008 OP 5/09.06 18-5...
  • Page 304 Chapter 18: Option BPM (Blood Pressure Monitoring) 18-6 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 305: Option Cbpm

    Chapter 19: Option CBPM 19 Option CBPM (not yet available) Fresenius Medical Care 5008 OP 5/09.06 19-1...
  • Page 306 Chapter 19: Option CBPM 19-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 307 Fold-Out Sheet 20 BTM Option Fresenius Medical Care 5008 OP 5/09.06...
  • Page 308 Inserting the tubing system into the measuring heads BTM events BTM SCREEN BTM T control, graphic BTM rec., graphic...

  • Page 309: Option Btm (Blood Temperature Monitor)

    Note The ambient temperature must match the ambient temperature set in the Operator setup, BTM submenu. Do not cover the blood lines, as this would result in a deterioration of the measuring accuracy. Fresenius Medical Care 5008 OP 5/09.06 20-1...

  • Page 310: Menu Overview

    Temperature change rate Entry of the body temperature change rate. Recirculation Display of the complete recirculation fraction. Temperature change Display of the body temperature change since beginning of the treatment. BTM menu button 20-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 311: Preparation

    (Automatic, depending on the settings in the Operator setup.) After completion of the recirculation measurement, the result is displayed in the BTM menu under Recirculation. Aborting Touch the Recirculation I/O button. (Recirculation I/O indicator grey.) Fresenius Medical Care 5008 OP 5/09.06 20-3...

  • Page 312: Temperature Control

    – BTM T control (comprises the body temperature change and the dialysate temperature) – BTM rec. (comprises the arterial and the venous fistula temperature as well as the dialysate temperature) – BTM events (records up to 9 events) 20-4 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 313 Fold-Out Sheet 21 BVM Option Fresenius Medical Care 5008 OP 5/09.06...
  • Page 314 BVM SCREEN Inserting the tubing system into the measuring head BVM (Rel. blood volume, graphic) Inserting the tubing system without cuvette BVM, BPM BVM, events...

  • Page 315: Option Bvm (Blood Volume Monitor)

    – Do not insert the tubing without cuvette into the measuring head. – Place the tubing along the left side of the BVM measuring head. (See also fold-out sheet, figure "Inserting the tubing system without cuvette".) Fresenius Medical Care 5008 OP 5/09.06 21-1...

  • Page 316: Menu Overview

    - blood pressure alarm, the respective RBV will be determined and saved. At the end of the treatment, the highest of these values will be transferred to the PatientCard as the new 21-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 317 PatientCard. Displays the current, measured relative blood volume (percentage). Min. RBV Displays the lowest relative blood volume of the respective treatment (percentage). Displays the current hemoglobin concentration in mmol/l or g/dl. Fresenius Medical Care 5008 OP 5/09.06 21-3...

  • Page 318: Preparation

    When detecting blood inside the cuvette, the BVM automatically starts the measurement and determines its reference of RBV = 100 %. 21-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 319: Displaying Graphics

    BVM rate, according to the RBV. The minimum UF goal prescribed will imperatively be respected. After the UF control parameter (e.g. UF goal) was changed, the BVM minimum rate is automatically cleared. Fresenius Medical Care 5008 OP 5/09.06 21-5...
  • Page 320 XXX ml/min. – Confirm Touch the Confirm button. If possible, increase the blood flow at least up to the indicated value. If not, reduce the UF goal or prolong the UF time. 21-6 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 321: Network

    The DataXchange Panel provides an area of the 5008 monitor which can be controlled entirely from outside. The data shown is transmitted by a server and is displayed on the 5008 monitor. The data is entered to the server via the 5008 monitor.
  • Page 322 – pull out the patient card outside of treatment; or – select other screens, e.g. the UF SCREEN. DataXchange Panel data transfer If the indicator in the Patient ID display is flashing, new information for the DataXchange Panel is available. 22-2 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 323: Options Blk, Wet

    This, in turn, may be caused by a kink in the tubing system or by clots developing in the dialyzer. Fresenius Medical Care 5008 OP 5/09.06 23-1...

  • Page 324: Wet

    All affected components have to be disinfected or replaced in accordance with the manufacturer's specifications before the system is put into operation again. 23-2 Fresenius Medical Care 5008 OP 5/09.06...
  • Page 325 The threshold values for triggering a WET warning will be adjusted accordingly, in order to avoid following messages. If the Accept button is touched for the second time after a repeated warning, the WET will be deactivated for the rest of the treatment. Fresenius Medical Care 5008 OP 5/09.06 23-3...
  • Page 326 Chapter 23: Options BLK, WET 23-4 Fresenius Medical Care 5008 OP 5/09.06...

  • Page 327: To Be Observed Before Using The Smartbag Option

    24 Option smartbag 24.1 To Be Observed Before Using the smartbag Option The smartbag supplies the 5008 hemodialysis system with concentrate provided in a 5-liter bag. For this purpose, the concentrate suction tube (red) has been modified appropriately for connection with the smartbag.

  • Page 328: Removing The Smartbag

    1 Close the clamp on the smartbag. 2 Open the concentrate flap. 3 Remove the concentrate connector (red) from the smartbag and connect it to the rinse chamber. 4 Close the concentrate flap. 5 Remove the smartbag. 24-2 Fresenius Medical Care 5008 OP 5/09.06...

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