Maquet ROTAFLOW User Manual
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Maquet ROTAFLOW User Manual

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USER'S MANUAL
ROTAFLOW WITH ICU KIT
ROTAFLOW SYSTEM

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  • Page 1 USER’S MANUAL ROTAFLOW WITH ICU KIT ROTAFLOW SYSTEM...
  • Page 2 Manufacturer MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany Telephone:+49 (0) 7478 921-0 Fax: +49 (0) 7478 921-100 info@maquet-cp.com www.maquet.com ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 3: Table Of Contents

    5.4 Disconnection from a heart-lung machine during operation 5.5 Using Emergency Drive PART 6 CLEANING AND DISINFECTION AFTER EACH USE PART 7 MAINTENANCE AND SERVICE 7.1 Maintenance 7.2 Service ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 4 PART 9 MESSAGES 9.1 Messages during self-test 9.2 Error messages PART 10 TECHNICAL DATA 10.1 General 10.2 ROTAFLOW Console 10.3 ROTAFLOW Drive 10.4 ROTAFLOW Emergency Drive ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 5: Part 1 General

    JOCAP XL online. Use in ELS System The ROTAFLOW Console with ICU Kit can be used as a component of the ELS System. The ELS System is used for extended respiratory and/or circulatory ROTAFLOW with ICU Kit | User’s Manual | English | 1.0...
  • Page 6 Holder. The ROTAFLOW Drive is installed on the Mobile ELS Holder. Use in PLS System The ROTAFLOW Console with ICU Kit can be used as a component of the PLS System. The PLS System is used for extended respiratory and/or circulatory support.

  • Page 7: Safety

    Equipotential bonding 1.1.2 SYMBOLS OF CONTROLS AND DISPLAY ELEMENTS Intervention LED “Level Monitoring” Intervention LED “Bubble Monitoring” Intervention LED “Pressure Monitoring” ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 8 “Audio off” button “Level override” button “Bubble override” button “Zero adjustment” button “Clamp” button Rotary pressure knob “External power” lamp “Battery operation” lamp “Battery charging” lamp ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 9: Precautions

    The system should only be used under supervision. The system must be continuously monitored by qualified staff to ensure patient safety. Clinical procedures and methods are the responsibility of the physician. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 10 Do not use the ROTAFLOW System in suction mode. The ROTAFLOW System should only be used with a valve or other adequate systems or methods (e.g., two tube clamps) preventing a reverse flow. If the pump stops during an operation, the blood flow will be interrupted and supply to the patient will cease.
  • Page 11 1.2.3 EXTERNAL DEVICES WARNING! If you are using the ROTAFLOW System with other medical devices, check the total leakage currents. Check that all devices comply with IEC 60601-1. Check that all devices connected to the digital interface of the ROTAFLOW System satisfy the IEC specifications (IEC 60950 for data processing equipment located more than 1.5 meters from the operating table and...
  • Page 12 For flow regulators without a rotary pressure function there is the risk of the knob being turned accidentally, which changes the flow. It is therefore only permitted to use the ROTAFLOW Console with ICU Kit for transport applications. WARNING! Danger if warning signals are not heard In noisy environments, there is the risk that acoustic warning signals emitted by the ROTAFLOW Console may not be heard.
  • Page 13 Avoid kinking tubes or cables. Do not drop any of the components. WARNING! Risk of power failure An inadequate power supply may put the ROTAFLOW Console out of service. Please therefore note: Always start work with the battery of the ROTAFLOW Console fully charged.

  • Page 14: Abbreviations

    FLIM Lower flow limit (“Flow limit”) Heart-lung machine Revolutions per minute Liters per minute l/min 4.1 “Modes”, page 31 ART PULS STAND AL FREE ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 15: Part 2 System Components

    | 15 | SYSTEM COMPONENTS ROTAFLOW Console with ICU Kit ROTAFLOW Drive ROTAFLOW Emergency Drive ROTAFLOW Centrifugal Pump Capacitive level sensor with level sensor pad ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 16: Rotaflow Console With Icu Kit

    “Battery charging” lamp (orange) The “Battery charging” lamp lights up when the battery is being charged. It extinguishes once the battery is fully charged. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 17 9 “Messages”, page 49) Set button The set button is used to confirm the setting or value selected ( 4.2 “Selecting settings”, page 33). ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 18 You can use the “Clamp” button to confirm that suitable systems or methods are available (e.g., two tube clamps) to prevent a reverse flow ( 3.7 “Switch on ROTAFLOW Console, Self-test”, page 29). ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 19 For operation on a MAQUET heart- lung machine: Plug Protective plug cap Securing mechanism for protective cover Openings for holding pins of heart- lung machine console ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 20 Special mains power switch (rear) EMC filter (in housing) The ROTAFLOW Console with ICU Kit is identified at the rear with a label stating “Upgrade ICU” [1]. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 21: Rotaflow Drive

    Flow meter and bubble sensor Hydraulic bolt for arm joints ROTAFLOW EMERGENCY DRIVE Position for ROTAFLOW Centrifugal Pump Speed display Hand crank Wing bolt Holders ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 22 2 System Components ROTAFLOW with ICU Kit | 22 | ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 23: Part 3 Connection And Installation

    Switch on mains power switch at rear of ROTAFLOW Console. OPERATION ON A HEART-LUNG MACHINE: INSTALL ROTAFLOW CONSOLE Operating position on a heart-lung machine ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 24 The holding pins must be inserted in the housing of the ROTAFLOW Console. Switch on the pump switch on the console of the heart-lung machine. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 25: Install Rotaflow Drive

    Use the wing bolt to secure the ROTAFLOW Drive to a stable pole (diameter 25 mm … 40 mm) or to the holder for the ROTAFLOW Drive on the ROTAFLOW Console. Make sure that the on/off switch of the ROTAFLOW Console is switched off.

  • Page 26: Operation As A Stand-Alone Device: Install Level Sensor

    The arrow must be pointing to the right at the desired height. Attach the level sensor to the level sensor pad. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 27: Connect Tubes

    3 Connection and Installation | 27 | Make sure that the on/off switch of the ROTAFLOW Console is switched off. Connect the level sensor to the “CLS” socket on the ROTAFLOW Console. Press the “Level override” button (briefly) to switch on level monitoring.
  • Page 28 Insert the ROTAFLOW Centrifugal Pump into the ROTAFLOW Drive. Check that the ROTAFLOW Centrifugal Pump is positioned under the holder of the ROTAFLOW Drive. Close the lock. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 29: Switch On Rotaflow Console, Self-Test

    When using as a stand-alone device, switch on the mains power switch at rear of ROTAFLOW Console. Otherwise the ROTAFLOW Console will default to battery operation after being switched on, thus discharging the batteries. Open the cover of the on/off switch on the front.

  • Page 30: Removal

    REMOVAL WARNING! If you are not using the ROTAFLOW Console, switch off using the on/off switch. If you only remove the power cord, switch off the mains power switch at the rear of the ROTAFLOW Console or the pump switch of the heart-lung machine, you will only be disconnecting the external power supply.

  • Page 31: Part 4 Operation

    Before starting the application, check the items listed in 4.4 “Checks before usage”, page 35. Only ever start the application when the battery of the ROTAFLOW Console is fully charged. MODES The relevant mode must be selected for the ROTAFLOW System in each case.
  • Page 32 You must reset the bubble sensor after a bubble intervention. This also applies to bubble interventions prior to the actual application (e.g., during priming). To do so, press the “Bubble override” button briefly (less than 3 seconds). ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 33: Selecting Settings

    Settings can only be changed at a flow of 0 rpm. It is therefore advisable to establish all settings before starting the application. Modes “ART” and “ART PULS” only with operation on a heart-lung machine ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 34: Priming And Zero Calibration

    An acoustic signal is emitted and the status display shows the mode. Note If the lower flow limit (FLIM), lower speed limit (LLIM) or upper speed limit (HLIM) is exceeded, the ROTAFLOW Console emits an acoustic alarm and an error message flashes ( 9.2.2 “In speed and flow displays”, page 49).

  • Page 35: Checks Before Usage

    ROTAFLOW with ICU Kit 4 Operation | 35 | When the ROTAFLOW Centrifugal Pump stops, and a flow within ± 1 l/min is displayed, press the “Zero adjustment” button for three seconds to calibrate flow measurement to zero. 4.3.1 BUBBLE MONITORING: PERFORMANCE TEST...

  • Page 36: Flow Regulation

    WARNING! If a bubble, level or pressure intervention occurs during flow regulation, the ROTAFLOW System will aim for a flow of 0 l/min. This does not however necessarily correspond to a speed of 0 rpm. Never clamp a tube during flow regulation ( 1.2.1 “Clamping the tube”, page...
  • Page 37 ROTAFLOW with ICU Kit 4 Operation | 37 | The status display indicates whether the ROTAFLOW System was stopped by an intervention. The ROTAFLOW Console emits an acoustic signal. STOP BUB Stopped by bubble monitoring STOP LEV Stopped by level monitoring 4.6.1...

  • Page 38: Modes "Art" And "Art Puls": Interventions

    Stop when the level of liquid in the reservoir is low Monitoring is performed via the monitoring systems of the heart-lung machine User’s Manual for heart-lung machine). The status display indicates whether the ROTAFLOW System was stopped by an intervention. The heart-lung machine emits an acoustic signal. STOP BUB...

  • Page 39: Part 5 Safety

    If the monitoring system of the heart-lung machine is switched off during operation, or a communication error occurs, the ROTAFLOW System stops and the relevant intervention LED flashes. An acoustic alarm is emitted and the status display flashes [NO COMM.].
  • Page 40 The batteries are automatically charged when the ROTAFLOW System is connected to the external power supply. For power to be supplied from mains, the mains power switch at the rear of the ROTAFLOW Console has to be switched on. 5.2.1...

  • Page 41: Replacing Ultrasonic Contact Cream

    (drainage) of the patient’s blood. The minimum speed is the speed at which the patient and line pressure are exceeded. Clamp the outlet tube of the ROTAFLOW Centrifugal Pump to prevent a reverse flow. Reduce the speed to 0 rpm.
  • Page 42 – Press the “Zero adjustment” button for three seconds to calibrate flow measurement to zero. Set the speed to 1500 rpm to overcome the patient and line pressure. Open the tube clamp. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 43: Disconnection From A Heart-Lung Machine During Operation

    Monitoring system, power supply and 1 – 11 physical If level monitoring is selected for the ROTAFLOW System, override it on the heart-lung machine. Connect the level sensor to the “CLS” socket on the ROTAFLOW Console. Switch off the pump switch on the console of the heart-lung machine.

  • Page 44: Using Emergency Drive

    Fit the protective cap to the connection socket of the heart lung machine. Bubble and level monitoring in “STAND AL” mode Monitoring is performed by the internal bubble sensor of the ROTAFLOW Drive and a level sensor, which is connected to the ROTAFLOW Console.

  • Page 45: Part 6 Cleaning And Disinfection After Each Use

    CLEANING AND DISINFECTION AFTER EACH USE ATTENTION! Risk of damage to equipment Make sure that no liquids enter the ventilation slit of the ROTAFLOW Drive. Never flush the system with large amounts of water. Do not use chemical solvents (e.g., alcohol, ether or acetone).

  • Page 46: Part 7 Maintenance And Service

    If fully charged batteries fail to operate the system for at least 30 minutes. Disposal of batteries Return batteries to MAQUET for environmentally friendly disposal. Remove the ventilation slot collar of the ROTAFLOW Drive and clean the ventilation holes regularly. Maintenance and repairs may only be performed by personnel authorized by MAQUET.

  • Page 47: Part 8 Accessories

    ROTAFLOW Drive ROTAFLOW Emergency Drive Ultrasonic contact cream (Order no. 102 27 54) Capacitive level sensor Level sensor pads, 100 pcs. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 48 8 Accessories ROTAFLOW with ICU Kit | 48 | ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 49: Part 9 Messages

    LOW BAT. The batteries are almost depleted. 5.2.2 “Battery voltage during battery operation”, page 40 NO SEL Console control module in the heart-lung machine ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 50 The ROTAFLOW Centrifugal Pump continues to function nevertheless. STAT Flow meter status TEMP Flow meter temperature TXRX Transmission receiver of flow meter. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 51 Offset voltage too high Internal data memory REFERENC Internal voltage reference is out of range by more than ±5%. Internal program memory SEL-LINE Reprogramming ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 52 If the temperature of the electronics exceeds 45°C, the ventilator switches to full speed. If the ROTAFLOW System stops because the temperature is too high, it cannot be started again until the temperature has fallen. No temperature messages should appear under normal operating conditions.

  • Page 53: Part 10 Technical Data

    66 … 106 kPa 66 … 106 kPa 66 … 106 kPa Note If storage and transportation exceed 15 weeks, comply with the ambient conditions for operation. ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 54: Rotaflow Console

    500 … 4500 rpm (resolution 500 rpm) SET HLIM Upper speed limit Off, 3000 … 5000 rpm (resolution 500 rpm) SET CLAM Not used: Automatic or manual tube clamp ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...

  • Page 55: Rotaflow Drive

    Diameter × length 102 × 270 mm Length (handle folded in) 185 mm Holder radius of action Approx. 210 mm Weight Approx. 2.2 kg ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 56 10 Technical Data ROTAFLOW with ICU Kit | 56 | ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen...
  • Page 58 ArjoHuntleigh for patient Please visit our website handling and hygiene, disinfection, DVT prevention, medical beds, therapeutic surfaces and diagnostics, GETINGE for infection control www.maquet.com and prevention within healthcare and life science and MAQUET for Surgical Workplaces, Cardiovascular and Critical Care.

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