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Eurosets COLIBRI SYSTEM Instructions For Use Manual

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COLIBRÌ SYSTEM
INSTRUCTIONS FOR USE
EU11042_ENG Rev.08 - 2023-11-17

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Summary of Contents for Eurosets COLIBRI SYSTEM

  • Page 1 COLIBRÌ SYSTEM INSTRUCTIONS FOR USE EU11042_ENG Rev.08 - 2023-11-17...

  • Page 2: Table Of Contents

    INDEX 1. GENERAL INFORMATIONS ........................... 4 1.1. SAFETY NOTES ................................. 4 1.2. DEFINITIONS ..................................4 1.3. DESCRIPTION ..................................5 1.4. INTENDED PURPOSE ..............................5 1.5. PATIENT POPULATION ..............................5 1.6. INDICATIONS FOR USE ..............................5 1.7. CONTRAINDICATIONS ..............................5 1.8. INTENDED USER AND ENVIRONMENT ........................5 1.9.
  • Page 3 8. POWER SUPPLY ..............................35 8.1. INTERNAL BATTERY..............................35 8.2. EXTERNAL BATTERY ..............................35 8.3. POWER CONNECTIONS PRIORITY ..........................36 8.4. RECHARGEABLE BATTERY AUTONOMY ........................37 8.5. SUPPLY MODE................................37 9. MEDICAL DEVICES FOR USE WITH COLIBRÌ SYSTEM .................. 38 10.

  • Page 4: General Informations

    1. GENERAL INFORMATIONS 1.1. SAFETY NOTES Information to draw the user’s attention to potentially dangerous situations and to ensure correct and safe use of the device is indicated in the text as follows: Warning Indicates possibility of injury, death, or other serious adverse reaction associated with the use or miuse of the device.

  • Page 5: Description

    1.5. PATIENT POPULATION Within the specified rated blood flow, the COLIBRÌ System, when used in combination with Eurosets Disposable Centrifugal Pump, can be used on patients specified on Eurosets Disposable Centrifugal Pump instructions for use. 1.6. INDICATIONS FOR USE Within the specified rated blood flow, the COLIBRÌ...

  • Page 6: Clinical Benefits

    1.9. CLINICAL BENEFITS COLIBRÌ System contributes to achieve the following potential clinical benefits: • improve survival rate respect the conventional (and/or medical) therapy; • allow to perform CPB procedure. 1.10. RISKS AND SIDE EFFECTS Possible risks and side effects include but are not limited to: •...

  • Page 7: General Warnings

    The Instruction for Use Manual is also provided on Eurosets website. • In case of incorrect visualization of Use Manual on Eurosets website, contact the technical service. • The device must be used in accordance with these instructions. EUROSETS cannot be held responsible for damage deriving from improper use.
  • Page 8 to collapse of the ventricle or blood vessels, inlet cannula obstruction, air aspiration, outgassing, cavitation and increased risk of embolism.

  • Page 9: Warnings For The Patient Transport

    1.12. MEDICAL DEVICES FOR USE WITH COLIBRÌ SYSTEM COLIBRÌ System is conceived to be used in combination with Eurosets Disposable Centrifugal Pump, Tubing Sets and Oxygenators. Alternatively, other commercially available (CE Marked) Tubing Sets and/or oxygenators approved for the concerned application may be used. COLIBRÌ System can be used also in combination with ECMOLIFE System.

  • Page 10: Symbols Description

    1.13. SYMBOLS DESCRIPTION Symbol Explanation Symbol Explanation Manufacturer CLASS II equipment DEFIBRILLATION-PROOF TYPE CF Date of manufacture APPLIED PART Serial number Atmospheric pressure limitation Catalogue number Temperature limit Do not use if package is damaged and Humidity limitation consult instructions for use This way up On/Off (Push/push) Fragile, handle with care...

  • Page 11: Transport And Storage Conditions

    EUROSETS S.r.l. Strada Statale 12 n°143 41036 Medolla (MO) ITALY The device must be shipped carriage free. EUROSETS S.r.l. does not assume any responsibility for damage to the device or its loss during transport.

  • Page 12: System Components

    2. SYSTEM COMPONENTS 2.1. GENERAL DEVICE DESCRIPTION COLIBRÌ System is composed by: EU5095 – COLIBRÌ Console EU6714 – COLIBRĺ Flowmeter 3/8” x 3/32” EU6730 – COLIBRÌ AIR/FLOW SENS 1/4X3/32 EU6716 – COLIBRÌ Power Module...
  • Page 13 Check the activation of Alarm LED. In case of failure in the activation the use of the device must be interrupted. • Eurosets disclaims the relevant risk of a use of a device with backup Colibrì not checked. Caution Place the equipment in order to not cover the air intakes to allow a proper heat dissipation.

  • Page 14: Console

    2.2. CONSOLE The console main parts are summarized as shown below: 1. COLIBRÌ top panel 2. COLIBRÌ display 3. COLIBRÌ right panel 4. COLIBRÌ left panel 5. COLIBRÌ bracket...

  • Page 15: Top Panel

    2.2.1. TOP PANEL The top panel is composed by: 1. ON/OFF button; 2. P3to1 disposable pressure sensor connection; 3. Main Power Supply connection; 4. 24V connection; Connected to the bracket rear side: 5. COLIBRÌ hanging system Warning Do not install extra device, different from devices indicated by the manufacturer, on the COLIBRÌ hanging system.

  • Page 16: Right Panel

    2.2.3. RIGHT PANEL The right panel is composed by: 1. External Battery connection #1; 2. External Battery connection #2; 3. WiFi Antenna; 2.2.4. LEFT PANEL The left panel is composed by: 1. Flowmeter/Air sensor connection; 2. USB; 3. Emergency switch. Warning •...

  • Page 17: Flowmeter / Air Sensor Connection On The Tubing

    15cm straight tube before and after the transducers. Check the indications on the EUROSETS tubing set to identify the suggested flowmeter positioning, in order to minimize the flow turbulence and the associated measurement inaccuracies related to the sensor.

  • Page 18: Disposable Centrifugal Pump And Oxygenator Setup

    Warning Eurosets Disposable Centrifugal Pump instructions for use shall be consulted.

  • Page 19: User Interface

    5. USER INTERFACE 5.1. DISPLAY STATUS BAR On the top of touchscreen there is the status bar with the following settings: 1. Date and Time; 2. Charge status Symbol and remaining time; The status bar color indicates priority of ongoing alarm: Color Priority High priority alarm...
  • Page 20 TOOLBAR At the bottom of the touchscreen, the toolbar collects the main features provided by the device: 1. Settings, 2. Pressure, 3. Alarms, 4. Navigation button SETTINGS In the Settings screen you can modify the following options: Language Date/Time Brightness System Display Service (not available during...
  • Page 21 System Show system info. HW and SW version. Download In this section you can download the patient data and save it into any memory drive by connecting an USB key to the Primary USB key connection in the front panel. During the treatment, is possible to download the last treatment performed and/or the treatment ongoing.

  • Page 22: Navigation Button

    BUBBLE SENSOR SCREEN Select Bubble sensor menu you can enable or disable the air bubble detection. default, bubble detection is not active. The Menu Icon will be update in accordance with the bubble detection status: bubble detection activated bubble detection activated.

  • Page 23: Toolbar

    5.2. TOOLBAR Parameters displayed in the main screen are listed below: Measure Parameter Description Sensor Measure unit Accuracy range ±0.07 l/min for flow Colibrì Detected blood value <= 1.0 l/min Blood flow FLOWMETER 3/8” 0,0 ÷ 10,0 flow speed ± 7% for flow value x 3/32””...

  • Page 24: Screen Lock

    PARAMETERS EDITING COLIBRÌ Console provides 4 membrane buttons: 1. Increase parameter value; 2. Decrease parameter value; 3. Return button; 4. Lock Screen button. Parameter selection You can activate the parameter selection that you want change, pushing for at least 1 second directly on the value that you want to modify on the touchscreen.

  • Page 25: Functionalities

    5.3. FUNCTIONALITIES TURNING ON THE DEVICE Once COLIBRÌ Console is turned on, the diagnostic page will be displayed. DIAGNOSTIC PHASE During the diagnostic phase, the device will check if motor driver and flowmeter are properly connected. Be sure the centrifugal pump is inserted and correctly primed during the diagnostic phase.

  • Page 26: Automatic Priming And Self Learning Procedure - Adult/Paediatric Configuration

    Empty circuit might cause disposable centrifugal pump rupture or device malfunctions. • In case of automatic priming failure, Eurosets Disposable Centrifugal Pump, Tubing Sets and Oxygenators instruction for use shall be consulted to perform manual priming. START / STOP PROCEDURE You can select “START PRIMING”...

  • Page 27: Automatic Priming And Self Learning Procedure - New Born Configuration

    5.3.2. AUTOMATIC PRIMING AND SELF LEARNING PROCEDURE – NEW BORN CONFIGURATION After manual priming is possible to continue with the automatic priming operation which also perform a centrifugal pump self-learning procedure in order to improve the centrifugal pump safety and performances. Warning Automatic Priming must be executed once the circuit has been correctly filled with priming solution.

  • Page 28: Operating Mode

    OPERATING MODE When using the device, the desired RPM or pump blood flow values can be set by the user. DRIVER RPM MONITORING MODE (DEFAULT MODE) Default mode allows to control the centrifugal pump RPM, the blood flow will adapt to the set RPM. RPM values can be set by using the panel +/- buttons.

  • Page 29: Alarms

    6. ALARMS 6.1. ALARM RANGE AND PARAMETERS It is possible to set the alarm limits in the Alarm screen. The alarm activates whenever the parameter value exceeds the warning limits, i.e: • Value measured above the upper limit • Value measured above the lower limit You can set the alarm limits within the parameters summarized in the following table.

  • Page 30: Alarm Limit - New Born Configuration

    6.1.2. ALARM LIMIT – NEW BORN CONFIGURATION Default Preliminary Measure Measure Alarm Parameter Description Sensor alarm Verification range unit threshold threshold Check no occlusions or Clamp on Detected any other case transducer Blod flow blood flow 0,0 ÷ 3,0 0,0 ÷ 3,0 0,2 ÷...

  • Page 31: Alarms Priority

    6.3. ALARMS PRIORITY Alarms activation depends strictly from the priority ranking of parameter involved, according to the following table. Priority Ranking Parameter Priority level Color Blood Flow High Pump Speed High Bubble High Pdrain Medium Yellow Medium Yellow Pout Medium Yellow 6.4.

  • Page 32: Combination System Ecmolife-Colibri

    It is possible to use the Colibrì system in combination with the Primary section of ECMOLIFE System. • The combined system must be used in accordance with these instructions and EU10583 IFU ECMOLIFE SYSTEM. EUROSETS cannot be held responsible for damage deriving from improper use. •...
  • Page 33 FUNCTIONAL CONNECTION Using the dedicate cable (ECMOLIFE-COLIBRÌ cable EU11108), you can connect the COLIBRÌ system to the ECMOLIFE System as follow: 1. Check the integrity of ECMOLIFE-COLIBRÌ cable. 2. Ensure the ECMOLIFE-COLIBRÌ cable to the dedicated socket of ECMOLIFE connector panel.

  • Page 34: Functionalities

    7.2.1. TURNING ON THE ECMOLIFE-COLIBRI’ SYSTEM In the Select Modality page of ECMOLIFE System select between “COLIBRÌ Configuration”. It is possible to connect the COLIBRI System to ECMOLIFE in any treatment phase. Likewise, it is possible to regain control on COLIBRI disconnecting the connection cable or through the “COLIBRI”...

  • Page 35: Power Supply

    8. POWER SUPPLY 8.1. INTERNAL BATTERY The device can work with both mains and internal battery powers. In battery operation mode, in full charged condition, the guaranteed time for the device to function correctly is at least 200 min. The device automatically switches to battery operation when the power supply is interrupted. When the external main power supply is available again, the device automatically returns to the external power supply.

  • Page 36: Power Connections Priority

    Battery charge status can be checked from display menu, according to the table below: Battery #1 connected. Battery status >70% Battery #2 connected. Battery status >70% Battery #1 connected. Battery status between 20% and 70% Battery #2 connected. Battery status between 20% and 70% Battery #1 connected.

  • Page 37: Rechargeable Battery Autonomy

    8.4. RECHARGEABLE BATTERY AUTONOMY In battery operation mode, in full charged condition, the guaranteed time for the device to function correctly is at least 200 min. The reported autonomy value is purely approximate, it may vary greatly due to different factors such as the number of connected sensors, the residual charge in the battery, the operating temperature, the natural decay of the battery over time, etc.

  • Page 38: Medical Devices For Use With Colibrì System

    9. MEDICAL DEVICES FOR USE WITH COLIBRÌ SYSTEM The Colibrì System shall be used in combination with Colibrì Tablet display. Code Description Image EU5256 COLIBRÌ TABLET The Colibrì Tablet is equipped with Colibrì APP to mirroring all treatment parameters. The connection between Colibrì System and Colibrì tablet is achieve via Wi-Fi communication. Warning Colibrì...
  • Page 39 TREATMENT PAGE The information related to Colibrì System treatment are shown in the upper part of the treatment Page. The following parameters are mirrored: LPM, RPM, Pdrain, Pin, Pout,...

  • Page 40: Connection Page

    In the two side bars of the screen, the toolbar collects the main features provided by the APP: Graphs Connections Settings (not available) Exit Alarms (not available) Alarms list (not available), CONNECTION PAGE In the Connection screen you can visualize client devices connected to the network. For each of them, the following information are reported: The serial number The probe model (in case of accessories probe such as arterial/venous probe)

  • Page 41: Graphs Page

    GRAPHS PAGE In this section you can visualize the real time parameters trends. From a PARAMETERS drop-down menu, you can choose the parameters to display on the interface. You can graph from a minimum of one to a maximum of three parameters at the same time in the page.
  • Page 42 A TIME drop-down menu allows the operator to select the time scale to visualize the trend. The following time scale (period) are available: Last 5 min; Last 15 min; Last 30 min; Last 60 min. To scroll the graph, use the arrow displayed near each graph. By pressing LIVE button you will able to activate/deactivate the real time parameters update.

  • Page 43: Intra-Hospital And Inter-Hospital Ecmolife Transportation

    10. INTRA-HOSPITAL AND INTER-HOSPITAL ECMOLIFE TRANSPORTATION 10.1. LEONARDO TROLLEY AND LEONARDO SLIM LEONARDO Trolley EU5093 and LEONARDO Slim EU5094 are the trolleys conceived to safely support and transport the COLIBRÌ Console during intra- hospital transport. Warning Consult the specific User Manuals/IFU EU10814 IFU Leonardo Trolley/IFU EU10814/S IFU Leonardo Slim for the related...

  • Page 44: Ambulance Power Module

    10.3. AMBULANCE POWER MODULE During road ambulance transport, in case of low battery and/or main supply not available, the device can be powered from the 24V Ambulance socket to its relevant 24V socket. In order to avoid any electrical interference between COLIBRÌ...

  • Page 45: Foil Stretcher Holder Plate

    10.4. FOIL STRETCHER HOLDER PLATE FOIL STRETCHER HOLDER PLATE EU3996 is conceived to safely support and transport the COLIBRÌ SYSTEM during road ambulance transport through a dedicated interface which can be located between the legs of the patient. Warning Consult the specific User Manuals/IFU EU11053 IFU FOIL for the related technical data (weight, connections, etc.) and for its correct use.

  • Page 46: Technical Specifications

    11. TECHNICAL SPECIFICATIONS Regulations Classification Classified in accordance with Regulation (EU) 2017/745 (MDR) • IEC 60601-1:2005+AMD1:2012+AMD2:2020 • IEC 60601-1-2: 2014+AMD1:2020 • IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 • IEC 62304:2006 + AMD1:2015 • IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 • IEC 60601-1-12:2014+AMD1:2020 • IEC 62366-1:2015+AMD1:2020 • IEC 62353:2014 Reference standards •...
  • Page 47 Technical specifications • Forced air flow, from openings in the rear part of the device. • Air flow 0,45 m³/h internal axial fan – 24 Vdc – 1,92 W • Each device unit has its own cooling fan • The device dissipates the heat produced by the electronic circuits through the enclosure and through the convective air flow.
  • Page 48 Electrical specifications • Connection to electric power distribution system through power cord Colibrì Power Module EU6716 • Electromagnetic environment: hospital - dedicated supply systems • Power supply Connection to continuous current power source (24 Vdc) • Internal Battery: Li-Ion rechargeable batteries, 25.9 V, 10.4 Ah •...

  • Page 49: Electromagnetic Compatibility

    12. ELECTROMAGNETIC COMPATIBILITY COLIBRÌ System is intended for use in the electromagnetic environment specified below. User shall ensure that COLIBRÌ System is used in such environment. Guidance and manufacturer’s declaration – electromagnetic emissions Emissions test Compliance Electromagnetic Environment COLIBRÌ System uses RF energy only for its internal function.

  • Page 50: Maintenance - Servicing - System Lifespan

    13. MAINTENANCE - SERVICING - SYSTEM LIFESPAN 13.1. LIFECYCLE OF THE RECHARGEABLE INTERNAL BATTERY The battery pack must be changed every 36 months at the time of the third scheduled maintenance. 13.2. PERIODICAL MAINTENANCE PROGRAM COLIBRÌ System shall undergo periodical maintenance at 12 months intervals. The maintenance shall be carried out exclusively by manufacturer authorized personnel.

  • Page 51: Cleaning And Disinfection

    Not recommended substances could damage the device and compromise the cleaning and disinfection effectiveness. • Check with Eurosets S.r.l. before introducing new processes. This is the only way to ensure that these processes will not damage the unit. • When cleaning and disinfecting the COLIBRÌ System surfaces the safety instruction from the manufacturer of cleaning and disinfection agents must be observed.

  • Page 52: Cleaning Phase

    14.2. CLEANING PHASE • Clean the units housing, cable and couplings on all its accessible surfaces by wiping surfaces thoroughly with a disposable, clean, non-linting cloth moistened with the suggested cleaning solution, ensuring that moisture does not enter critical areas of the device (e.g., power connections) until all visible soil (i.e., blood and fluids) is removed.

  • Page 53: Annexes

    15. ANNEXES 15.1. ANNEX 1: ALARMS TABLE When connected to Ecmolife, alarms will appear and be handled by the Ecmolife screen. Only the alarm string will be displayed on Colibrì, and the top bar will color according to the priority of the alarm itself. On Ecmolife, Colibrì...
  • Page 54 Check any case which may compromise the flow are presents. Measured/selected RPM value is bigger Ensure appropriate RPM alarms are set. High RPM High than maximum value sets in Alarm Page Consider to decreased LPM (if LPM control is enable) to decrease the flow if appropriate.
  • Page 55 Press the alarm acknowledge button and wait the end of the calibration procedure. RPM Limitation Calibration is running Medium At the end of calibration procedure the yellow bar disappear and it is possible research higher RPM/LPM. An audible alarm will sound and the System will continue to operate.
  • Page 56 Check the Flow Probe connection on front of Console. In case of persistent error, try to disconnect and reconnect the flowmeter to Flow Sensor A technical error communication is its relevant connector and repeat the diagnostic phase. If the High Data Error detected on Blood Flow board anomaly persist, clamp the return tubing and switch to the backup...
  • Page 57 An audible alarm will sound and the System will continue to operate. Press the alarm acknowledge button, if the visual alarm SPI Master A technical error is detected on Motor message does not disappear, clamp the return tubing, stop the High Motor Timeout board...
  • Page 58 Turn off the device and switch to back-up section. Contact Technical Assistance. The connection between ECMOLIFE system and COLIBRI system has been interrupt. If the connection cable has been detached, re- ECMOLIFE device has been ECMOLIFE connect it to the console.
  • Page 59 EUROSETS SRL Strada statale XII, 143 – 41036 Medolla (MO) - Italy Phone (+39) 0535 660311 - Fax (+39) 0535 51248 http://www.eurosets.com...