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XVIVO XPS Instructions For Use Manual

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XVIVO PERFUSION SYSTEM (XPS™)
SOFTWARE ver. 5.2
INSTRUCTIONS FOR USE
Ref: 19030 (US) and 19040 (CE)
Serial Numbers: XPS0101+
TM
XVIVO Perfusion System (XPS
) Instructions for Use
-1-
P/N: 9182-0189 Revision Q

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  • Page 1 XVIVO PERFUSION SYSTEM (XPS™) SOFTWARE ver. 5.2 INSTRUCTIONS FOR USE Ref: 19030 (US) and 19040 (CE) Serial Numbers: XPS0101+ XVIVO Perfusion System (XPS ) Instructions for Use P/N: 9182-0189 Revision Q...
  • Page 2 XVIVO Perfusion AB, all rights reserved Subject to technical changes Because of continuous product improvements, the illus- trations and technical information found in the XPS User’s Guide may differ (slightly) from the current version of the device. User Guide References This document was created using information from: 1) CardioHelp User’s Manual/English/0.9.0...
  • Page 3 This way up ground stud within the cart frame) Fragile, handle with care Keep dry Temperature limitations Humidity limitations Atmospheric pressure limitations at transport and storage Stacking limitations XVIVO Perfusion System (XPS ) Instructions for Use P/N: 9182-0189 Revision Q...

  • Page 4: Table Of Contents

    2.2.1 XVIVO Organ Chamber 2.2.2 XVIVO Disposable Lung Circuit 2.2.3 Connect XVIVO Disposable Lung Circuit 2.2.4 Assemble STEEN Solution Spike Manifold 16 2.2.5 Connect Tubing Lines to XPS Cart 2.2.6 XVIVO PGM Disposable Sensor 2.2.7 Set Temperature 2.3 Power Up 2.4 STEEN Solution Perfusate Setup 2.4.1 CardioHelp XVIVO Pump Controls...
  • Page 5 CHAPTER 5 Notifications 5.1 Connections & Date/Time 5.2 XPS Software 65-72 CHAPTER 6 Equipment Alerts 6.1 Heater/ Cooler 6.2 CardioHelp XVIVO Alert Panels 6.2.1 CardioHelp XVIVO (Medium-priority) 76-77 6.2.2 CardioHelp XVIVO (Low-priority) 78-80 6.3 C3 Ventilator Alert Panels 6.3.1 C3 Ventilator...
  • Page 6 8) Appendix 1 Features 9.4.2 Maintenance & Service 9) Appendix 2 Cleaning & 9.5 XVIVO Perfusion Cart 9.5.1 Cleaning Maintenance 9.5.2 Maintenance & Service 10) Appendix 3 Tech Data XVIVO Perfusion System (XPS ) Instructions for Use P/N: 9182-0189 Revision Q...
  • Page 7 10.4.1 Technical Data 10.5 PGM (Sensors) Technical Specifications 10.5.1 Technical Data pH Sensor 10.5.2 Technical Data PO Sensor 10.6 XVIVO Perfusion Cart System Technical Specs 10.6.1 Product Classification 10.6.2 Physical Characteristics 10.6.3 Environmental Requirements 10.6.4 Pneumatic Specifications 10.6.5 Electrical Specifications 10.6.6 Control Settings...

  • Page 8: Steen Solution Tm Overview

    STEEN Solution™ is intended to be used with the XVIVO Perfusion System inflammatory cytokines and (XPS ) for flushing and temporary continuous normothermic machine...

  • Page 9: Chapter 1 Xps Tm

    Cart Overview Intended Use The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas- sessed for transplantation. (US) The XVIVO Perfusion System (XPS™) is intended for flushing and temporary continuous normothermic machine perfusion...

  • Page 10: Xps Operator Warnings And Cautions

    Warning: The XPS™ should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the XPS™ should be observed to verify normal operation in the configuration in which it will be used.
  • Page 11 Increase the separation between the XVIVO Perfusion Cart and the RF communications equip- ment • Connect the XVIVO Perfusion Cart into an outlet on a circuit different from that to which the RF communications equipment is connected • Deactivate the flow intervention. Incorrect flow values can trigger improper interventions.

  • Page 12: Chapter 2 Technical Operation

    2.1 TECHNICAL OPERATION The XVIVO Perfusion System (XPS ) provides a comprehensive platform for ex vivo lung perfusion and assessment. The XPS Perfusion Cart is designed with the following elements: • CardioHelp XVIVO centrifugal pump drive with integrated temperature (2) and pressure (2) sensors •...

  • Page 13: Xvivo Organ Chamber

    Carefully and MANUAL TIP: Throughout the aseptically, unwrap the first blue XPS IFU, you routinely see three drape layer away from the Cham- color-coded number circles: ber and pass off to a scrub tech or nurse.

  • Page 14: Xvivo Disposable Lung Circuit

    2.2.2 XVIVO Disposable Lung Circuit The XVIVO Disposable Lung Circuit provides the aseptic interface between the XPS cart hardware and the ex vivo lung. The following components are part of the pack:  Quadrox-iR centrifugal pump head/ oxygenation membrane/ heat exchanger ...

  • Page 15: Connect Xvivo Disposable Lung Circuit

     Sterilely connect the drain bag connector to the XVIVO Organ Chamber’s drain port.  Pass drain bag back over to the non-sterile ‘wet area’ to attach to wall hooks.

  • Page 16: Assemble Steen Solution Tm Spike Manifold

    NOTE: Tubing must be centered across peristaltic pump heads or damage/ kinking to the tubing may occur.  Connect STEEN Solution tub- ing to reservoir inlet port (Section 2.2.5). XVIVO Perfusion System (XPS ) Instructions for Use -16- P/N: 9182-0189 Revision Q...

  • Page 17: Connect Tubing Lines To Xps Cart

    Disposable Set-up 2.2.5 Connect Tubing Lines to the XPS Cart  Connect STEEN Solution spike tubing to reservoir inlet port  Locate the STEEN Solution drain tubing which comes off of the Quadrox-iR oxygenator and is not connected to anything else at its terminal end and has an or- ange-colored tape.

  • Page 18: Xvivo Pgm Disposable Sensor Tm

    2.2.6 XVIVO PGM Disposable Sensor  Open sensor package. NOTE: Keep packaging label to enter calibration data into XPS Software in a later step.  Aseptically connect sensor to disposable tubing set using quick connects. Sensor will only con- nect in the correct orientation.

  • Page 19: Set Temperature

    See Section 9.2 for filling directions.  Circulate water through the oxygenator’s heat exchanger membrane to eliminate bubbles and to check for leaks/cracks in the oxygenator housing. XVIVO Perfusion System (XPS ) Instructions for Use -19- P/N: 9182-0189 Revision Q...

  • Page 20: Power Up

    Exchange step (Section 4.3.7) consider warming half the bot- tles (3 to 4 bottles) to a normo- thermic temperature.  Ensure XPS is plugged into the wall outlet. Note: wall outlet should be equipped with back- up power.  Turn toggle switch to the up...

  • Page 21: Steen Solution Tm Perfusate Setup

    The main (Home) screen on the Touch display includes the follow- ing areas:  Status bar  Parameter display  Toolbar  Tab bar  Power supply status XVIVO Perfusion System (XPS ) Instructions for Use -21- P/N: 9182-0189 Revision Q...

  • Page 22: Prime Circuit With Steen Solution

    STEEN Solution bot- tle and twisting the bottle itself just enough to allow STEEN Solution run through the single spike line and into the reservoir itself. XVIVO Perfusion System (XPS ) Instructions for Use -22- P/N: 9182-0189 Revision Q...

  • Page 23: Flow/Bubble And Level Sensors

    NOTE: If fluid level should fall be- low level sensor, pump will stop operation until fluid level is re- stored. See Section 2.4.2 for res- ervoir filling instructions. XVIVO Perfusion System (XPS ) Instructions for Use -23- P/N: 9182-0189 Revision Q...

  • Page 24: Calibrate Flow Sensor

    (>1000), but the flow rate is dis- played as ‘0,’ check for kinks or obstructions in tubing lines and re-zero flow sensor as necessary. If the flow rate still reads ‘0,’ contact XVIVO for service/ sup- port. XVIVO Perfusion System (XPS ) Instructions for Use -24-...

  • Page 25: Calibrate C3 Ventilator

    2.4.5 Calibrate C3 Ventilator  Connect test lung to ventilator breathing circuit.  Connect breathing circuit to XPS side panel : Inhale port Exhale port  Connect the flow sensor tub- ing to the appropriately colored ports.  Connect venous mix gas line.

  • Page 26: Enter Setup Data

    EVLP. It allows the user to run a seamless EVLP through four re- cruitments. More user infor- mation is provided in Section 4.3.4. XVIVO Perfusion System (XPS ) Instructions for Use -26- P/N: 9182-0189 Revision Q...

  • Page 27: Xvivo Pgm Disposable Sensor Calibration

    PO data.  When values have been verified, click the “Calibrate” but- ton. NOTE: PGM calibration can only be done when the temperature is above 35º C. XVIVO Perfusion System (XPS ) Instructions for Use -27- P/N: 9182-0189 Revision Q...

  • Page 28: Weight Sensor

    With Tare Past Mode disabled pressing the Tare Button  Press the Weight Sensor Button to reconnect to the weight sensor. will only affect future data. XVIVO Perfusion System (XPS ) Instructions for Use -28- P/N: 9182-0189 Revision Q...

  • Page 29: Ups

     When the AC/mains power connection and the XPS is on bat- tery power, the AC-disconnected icon is shown to the right of the battery icon. The battery icon dis- plays battery life and AC- disconnected time.

  • Page 30: Chapter 3 Lung Preparation

    Recruitment maneuvers of Vt set to 10ml/kg for the last 10 mins. Retrograde Perfusion of every hour • Keep left atrial pressure at 3-5 mmHg during procedure Antegrade Perfusion Ventilation Settings New Lung Setup Alarm Settings XVIVO Perfusion System (XPS ) Instructions for Use -30- P/N: 9182-0189 Revision Q...

  • Page 31: Ideal Lung Cannulation

    •5 Tubing Clamps •1 Hammer •Suction •K Basins •Towels •Sterile Slush •15 Blade •Cannulas •2-0 Silks •9.0 ET Tube & Syringe •4-0 Prolene x 3 •IV Tubing •Sponges XVIVO Perfusion System (XPS ) Instructions for Use -31- P/N: 9182-0189 Revision Q...

  • Page 32: Left Atrial (La) Cannulation

    Lung Preparation 3.3.2 XVIVO Left Atrial (LA) Cannula The XVIVO Left Atrial Cannula is the cone-shaped cannula marked with the green taped end.  Measure the cone end to the donor lung left atrial cuff.  Cut the cone to better approximate atrial opening.

  • Page 33: Pulmonary Artery (Pa) Cannulation

    3.3.3 XVIVO Pulmonary Artery (PA) Cannula The XVIVO PA Cannula is the straight cannula marked with the yellow-taped end.  If the PA is intact, open up the lumen and insert the XVIVO PA Cannula into the opening.  Tie around the outside of the...

  • Page 34: Intubation

    Clamp the trachea to prevent lung deflation prior to intubation.  Insert ET tube into tracheal opening.  Tie around the outside of the trachea to secure ET tube in place. XVIVO Perfusion System (XPS ) Instructions for Use -34- P/N: 9182-0189 Revision Q...

  • Page 35: Single Lung Cannulation

    XVIVO Organ Chamber. CAUTION: remember that if evaluating only one lung, V should be reduced by 50% of calculated. See Section 3.3.11 XVIVO Perfusion System (XPS ) Instructions for Use -35- P/N: 9182-0189 Revision Q...

  • Page 36: Back Table Flush

     Move the lung bloc to the XVIVO Organ Chamber on the XPS Cart.  NOTE the ET tube remains clamped to keep the lungs inflated. XVIVO Perfusion System (XPS ) Instructions for Use -36- P/N: 9182-0189 Revision Q...

  • Page 37: Pressure Sensors

    STEEN Solution is then drawn back from the lung on the pressure lines, once the lungs have been added to the circuit. XVIVO Perfusion System (XPS ) Instructions for Use -37- P/N: 9182-0189 Revision Q...

  • Page 38: Zero Pressure Sensors

    (P Replace the luer caps and move the stopcocks back to the hori- zontal position (off to atmospheric pressure) as shown  in ( XVIVO Perfusion System (XPS ) Instructions for Use -38- P/N: 9182-0189 Revision Q...

  • Page 39: Prime Lung/Retrograde Flow

    Run the pump slowly at a starting flow rate of 100ml/min and trickle STEEN Solution into the left atrium of the lung via the XVIVO Left Atrial (LA) Cannula until it completely fills up with STEEN Solution  Connect the priming loop to...

  • Page 40: Antegrade Flow

    NOTE: to safely control the LA pressure, the hardshell reservoir may be raised or lowered to keep the outflow pressure 3-5 mmHg. Every 1 inch of height equals 2 mmHg pressure change. XVIVO Perfusion System (XPS ) Instructions for Use -40- P/N: 9182-0189 Revision Q...

  • Page 41: Ventilator Settings

    Setup Page Ventilator Settings.  Select Confirm on the Ventila- tor. NOTE: remember that if evaluat- ing only one lung, V should be reduced by 50% of calculated. XVIVO Perfusion System (XPS ) Instructions for Use -41- P/N: 9182-0189 Revision Q...
  • Page 42 Once the lung is around 37 this alarm can be changed back to the ideal calculated VT to silence the alarm. XVIVO Perfusion System (XPS ) Instructions for Use -42- P/N: 9182-0189 Revision Q...
  • Page 43 Alarms menu before ventilation started. In a cold lung, calculated V will not be met, and:  Pressure limitation Alarm will activate.  Press Alarm silence button. XVIVO Perfusion System (XPS ) Instructions for Use -43- P/N: 9182-0189 Revision Q...

  • Page 44: Chapter 4 Ex Vivo Lung Perfusion (Evlp) Procedure

    ΔPO :FiO ratios should trend ≥ 350 mmHg XPS Shutdown & Cleaning • A good lung will be able to maintain good assessment values over time. A fail- ing lung will begin to develop edema, resulting in decreased compliance, in-...

  • Page 45: Lung-Protective Flow Rates

    40% of calculated Double Lung Perfusion: Max Flow Rate= 40% CO Single (Rt) Lung Perfusion: Max Flow Rate= 24% CO Single (Lt) Lung Perfusion: Max Flow Rate= 16% CO XVIVO Perfusion System (XPS ) Instructions for Use -45- P/N: 9182-0189 Revision Q...

  • Page 46: Deoxygenation Gas

     Start the flow rate of the Gas mix at 1L/min.  Adjust flow rate as necessary to maintain a PCO between 35- 45 mmHg (4.7-6 KPa). XVIVO Perfusion System (XPS ) Instructions for Use -46- P/N: 9182-0189 Revision Q...

  • Page 47: Xvivo Pgm Disposable Sensors Tm Single

    EVLP Strategy 4.3.3 XVIVO PGM Disposable Sensor Single Point Calibration The XVIVO PGM Disposable Sensors come pre-calibrated to STEEN Solution directly out of the package. However, since this device is a trend-only monitor, clinical decisions should not be based on the PGM sensors alone.

  • Page 48: Smart Sequencing

    Timer 3 (Recruitment) will automatically start when recruitments are detected at the appropriate sequence. NOTE 1: The XPS software program can be run with SMART SEQUENCING turned off. Parameters, timers and trend graphs operate normally when SMART SEQUENCING is disabled.

  • Page 49: Lung Recruitment 1: Manual Breath

    PEEP setting, so for a 5 cmH O PEEP and Peak Pressure limited to 25 cmH O, the peak working pressure will be 25-5= 20 cmH XVIVO Perfusion System (XPS ) Instructions for Use -49- P/N: 9182-0189 Revision Q...

  • Page 50: Lung Recruitment 2: O2 Challenge Mode

    *NOTE: It is recommended that a confirmatory sample be drawn at the beginning and end of the EVLP procedure and/or if there is any doubt that the XPS in-line gas sen- sors are reading different values than the hospital analyzer. XVIVO Perfusion System (XPS...

  • Page 51: Chest Radiograph

    Place X-ray film beneath blue Organ Chamber table. NOTE: Take care not to disturb the sterile field.  Shoot picture onto film. Begin EVLP (20 minutes) EVLP at 120 minutes XVIVO Perfusion System (XPS ) Instructions for Use -51- P/N: 9182-0189 Revision Q...

  • Page 52: Steen Solution Tm Exchange

    Methylprednisolone (500 mg) Broad- spectrum antibiotic (500 mg) and/or anti-fungal medications if the donor was positive for fungal infection Heparin (range 3,000U-10,000U, where 10,000 U is the recommended value) XVIVO Perfusion System (XPS ) Instructions for Use -52- P/N: 9182-0189 Revision Q...

  • Page 53: Troubleshooting

    Strict control of the PAP and a low flow modality (150 mL/min) will warm up the vascu- lar tree without endothelial dam- age and progressively lower PVR. XVIVO Perfusion System (XPS ) Instructions for Use -53- P/N: 9182-0189 Revision Q...

  • Page 54: Impaired La Drainage

    LA pressures greater than 5 mmHg may prevent cyclic changes of the lung vasculature during ventilation. XVIVO Perfusion System (XPS ) Instructions for Use -54- P/N: 9182-0189 Revision Q...

  • Page 55: Low Ph

    45mmHg. Interventions include:  Increase PCO by increasing deoxygen gas. Decrease PCO by decreasing deoxygen gas.  Alternatively, expiratory ratio can be adjust- ed to control PCO XVIVO Perfusion System (XPS ) Instructions for Use -55- P/N: 9182-0189 Revision Q...

  • Page 56: Decreasing Steen Solution Tm Levels In

    This will result initially in a fall in lung compli- ance, impaired oxygenation and rise in PAP and peak airway pressures. XVIVO Perfusion System (XPS ) Instructions for Use -56- P/N: 9182-0189 Revision Q...

  • Page 57: Changing Out Oxygenator Pump Disposable

     Connect blue water hose Hansen connectors onto heat oxygenator heat exchange ports. XVIVO Perfusion System (XPS ) Instructions for Use -57- P/N: 9182-0189 Revision Q...

  • Page 58: Restart Xps Tm Software

    Troubleshooting 4.4.7 Restart XPS Software If for some reason the XPS Soft- ware freezes or locks up, the user may have to force a shut down and restart of the system soft- ware. CAUTION: Restarting the Software will reset all...

  • Page 59: Finishing Evlp

    Perfadex. Place in sterile bags with Perfadex. This method is very similar to a  Place sterile bags in insulated standard donor procurement protocol. cooler containing ice. XVIVO Perfusion System (XPS ) Instructions for Use -59- P/N: 9182-0189 Revision Q...

  • Page 60: Evlp Failure Assessment

    Decrease in Dynamic lung Compliance  Increase in weight NOTE: Graphing pixels will record red to indicate declining lung conditions and green to indicate improving conditions during graphing. XVIVO Perfusion System (XPS ) Instructions for Use -60- P/N: 9182-0189 Revision Q...

  • Page 61: Automated End Case Feature

    4.5.3 Automated End Case Feature The End Case button allows the user to exit the XPS software application, enter EVLP case notes, power down the comput- er or restart the computer. It offers a more graceful exit than simply powering off the moni- tor.

  • Page 62: Shutdown And Cleaning

    UPS button to force shut-down. Not recommended as a normal standard method. Cleaning (also see Chapter 9)  Remove circuit from XPS cart and dis- pose according to hospital biohazard materials policy.  Wipe down XPS cart surfaces with a mild disinfectant based on aldehydes, ammonium or alcohol which will not af- fect plastic materials.

  • Page 63: Chapter 5 Notifications

    XPS software. Notifications In addition to the Notice screen’s orange header bar, the XPS software will identify which piece of equipment is causing the notice through a graph- ical view of the XPS system, with the notice item highlighted in orange.

  • Page 64: Connections & Date/Time

    XPS Software to generate a notice.  Another helpful tool is to press the SERVICE button on the XPS touchscreen. This will open the Service window which shows each piece of equipment and whether or not it is connected to the touchscreen computer.

  • Page 65: Xps Tm Software

    Replace disposable sensor, recalibrate 5.2 XPS Software Loss of Mains AC/DC The main building power outlet Check that the XPS is plugged into the Switched to Battery is no longer working, the XPS is wall outlet and that the AC/mains Power unplugged from wall power, or switch is in the ON position.
  • Page 66 Ventilator FiO2 The oxygen percentage data Use ventilator readings for FiO2 for Invalid Data connection from the ventilator rest of procedure and ignore XPS soft- is corrupt ware. Contact XVIVO to schedule service Ventilator FiO2 Out The FiO2 data is outside of nor-...
  • Page 67 Action needed Ventilator Peak The Peak Pressure data connec- Use ventilator readings for Ppeak for Invalid Data tion from the ventilator is rest of procedure and ignore XPS soft- corrupt ware. Contact XVIVO to schedule service 5.2 XPS Software Ventilator Peak Out...
  • Page 68 Notifications from the Perfusate Gas Monitor will typi- cally be caused by either a disposable sensor failure or a communication failure between the fiber optic transmitter and the XPS Software monitor.  Check to make sure sensors are seated properly in their housings.
  • Page 69 LA pH PGM phase Data from LA PGM sensors is in- Check position of PGM disposable build up inside the XPS cart if there are any small leaks in the data corruption consistent between multiple sensor and re-seat if necessary gas lines.
  • Page 70 Reboot software if possible Contact XVIVO for service Ventilator date/time The date/time on the ventilator is Reset ventilator date/time corruption 5 minutes > or < than XPS time Ventilator freq data Data between XPS and ventilator Confirm ventilator power is on corruption disrupted and standby mode is ‘off’...
  • Page 71 The date and/or time is > 5 The date and/or time is > 5 Reset the date/time of the Centrifugal Reset the date/time of the Centrifugal minutes different than the XPS Date/Time Mismatch pump Date/Time Mismatch minutes different than the XPS...
  • Page 72 There is a hardware or loss of Check UPS cable connection to or Communication communication problem with touchscreen monitor Problem the UPS to the XPS software. Have the unit serviced XVIVO Perfusion System (XPS ) Instructions for Use -72- P/N: 9182-0189 Revision Q...

  • Page 73: Chapter 6 Equipment Alerts

    An equipment alert will emit an audible beep tone, display an alert message at the unit itself (for the heater/cooler, pump and ventilator). A notice will appear at the top header of the XPS software. Equipment Alerts...

  • Page 74: Heater/Cooler

    10 minutes). WATER LEVEL? Water level too low Fill up water to just below MAX- mark on level indicator Contact XVIVO customer service if Sensor defect defect is suspected Fill up water to just below MAX- CHECK UNIT ->...

  • Page 75: Cardiohelp Xvivo Alert Panels

     NOTE: The CardioHelp XVIVO pump software will not allow the user to disable the acoustic alarms. XVIVO Perfusion System (XPS ) Instructions for Use -75- P/N: 9182-0189 Revision Q...

  • Page 76: Cardiohelp Xvivo (Medium-Priority)

    (i.e. backflow Check clamps to ensure flow direction present) is antegrade No disposable Quadrox-iR oxygenator/pump Re-seat oxygenator into housing detected head is not properly connected XVIVO Perfusion System (XPS ) Instructions for Use -76- P/N: 9182-0189 Revision Q...
  • Page 77 Wrong target RPM The target RPM rate does not Check perfusion lines for kinks match user-defined level Change RPM limit settings Ensure clamps are positioned correctly XVIVO Perfusion System (XPS ) Instructions for Use -77- P/N: 9182-0189 Revision Q...

  • Page 78: Cardiohelp Xvivo (Low-Priority)

    Add STEEN Solution at the low point of the level detector Level sensor disconnected The level sensor is working but Reconnect level sensor is not connected to the disposa- XVIVO Perfusion System (XPS ) Instructions for Use -78- P/N: 9182-0189 Revision Q...
  • Page 79 LA (reservoir) is over the Change alert settings user-defined limit TVen below limit The temperature reading from Check heater/cooler unit the LA (reservoir) is under the Change alert settings user-defined limit XVIVO Perfusion System (XPS ) Instructions for Use -79- P/N: 9182-0189 Revision Q...
  • Page 80 NOTE: The centrifugal pump alerts listed on this page indicate Low-priority (static yellow) alarms which will not cause pump stop- page, but need to be evaluated/ addressed. XVIVO Perfusion System (XPS ) Instructions for Use -80- P/N: 9182-0189 Revision Q...

  • Page 81: C3 Ventilator Alert Panels

     Pressing the alarm pause button will stop the audible tone for 2 minutes. A red LED indica- tor will light during the audible pause. XVIVO Perfusion System (XPS ) Instructions for Use -81- P/N: 9182-0189 Revision Q...

  • Page 82: C3 Ventilator

    ISO 21647 oxygen cell NOTE: to prevent leakage within the ventilator, make sure an oxygen cell is installed at all times, even if an external monitor is used XVIVO Perfusion System (XPS ) Instructions for Use -82- P/N: 9182-0189 Revision Q...
  • Page 83 The colorless sens- ing line is close to the ventilator and must be attached to the white con- nector. XVIVO Perfusion System (XPS ) Instructions for Use -83- P/N: 9182-0189 Revision Q...

  • Page 84: Chapter 7 Equipment Alarms

    Pressing on any item in the list will open a new window with a graphic depiction of the XPS device with a red lit up area to draw the user’s attention to the alarming piece of hardware:...

  • Page 85: Heater/Cooler

    Power failure This alarm is triggered if the pow- Press power switch to off position er supply fails during operation. Plug XPS unit into different wall The Heater/cooler is NOT connect- outlet ed to the UPS system in the cart...

  • Page 86: Cardiohelp Xvivo

    Check clamp position reading outside of the limit for > 6 Check kinking in tubing seconds Battery discharged Backup battery is completely Move XPS power plug to a 7.2 CardioHelp XVIVO discharged different wall power outlet Contact XVIVO for service Bubble detected If a bubble is >5mm, this alarm...

  • Page 87: C3 Ventilator

    Device temperature The internal temperature of the Move ventilator to a cooler area high ventilator is higher than expected Check the cooling fans in the XPS Contact XVIVO for service Disconnection on VTE< 1/8 delivered VTI and Check lung patient side delivered VTI >...

  • Page 88: Chapter 8 Appendix 1 Additional Features

    Appendix 1 Additional Features CardioHelp XVIVO Display Features Tab Controls Menu Features Interventions Heater/Cooler Control Layout C3 Ventilator Setup Controls Graphics Monitoring Dynamic Lung Monitored Parameters XVIVO Perfusion System (XPS ) Instructions for Use -88- P/N: 9182-0189 Revision Q...

  • Page 89: Cardiohelp Xvivo

    Parameter Screen Go to Parameter Screen NOTE: Not used in this application Blood parameters Intervention Screen Go to the Interventions screen Timer Screen Go to the Timer screen XVIVO Perfusion System (XPS ) Instructions for Use -89- P/N: 9182-0189 Revision Q...

  • Page 90: Tab Controls

    4 timers (3 count-up, 1 count-down). Displayed parameters: Flow Rate (LPM) Pump Speed (RPM) ,   Count-up timers &   Count-down timer and set count time XVIVO Perfusion System (XPS ) Instructions for Use -90- P/N: 9182-0189 Revision Q...

  • Page 91: Menu Features

    To enable the feature again, press the following symbol:  To accept changes, press the green checkmark symbol. To reject/cancel, press the red “X” XVIVO Perfusion System (XPS ) Instructions for Use -91- P/N: 9182-0189 Revision Q...

  • Page 92: System Data & Information Settings

     Check System data/ information  Software version  Device serial number  Operating time since startup  Date of last service  Time until next service XVIVO Perfusion System (XPS ) Instructions for Use -92- P/N: 9182-0189 Revision Q...

  • Page 93: Pump Mode Settings

     Press in the center of the “X” as it moves around the screen until the screen calibration is complete. XVIVO Perfusion System (XPS ) Instructions for Use -93- P/N: 9182-0189 Revision Q...

  • Page 94: Intervention Settings

    CardioHelp XVIVO 8.4 Intervention Settings In the CardioHelp XVIVO, the settings for alarms and interventions can be user-defined for the following parameters: • RPM mode: Flow monitoring • Temperature monitoring • Pressure monitoring • Bubble monitoring 8.4.1 RPM Mode: Flow Monitoring Control ...

  • Page 95: Pressure Monitoring And Control

    STOP if the respective intervention is active and there is either a bubble detected in the perfusion line or the level of fluid falls below the level sensor. XVIVO Perfusion System (XPS ) Instructions for Use -95- P/N: 9182-0189 Revision Q...

  • Page 96: Heater/ Cooler

     An alert (low to medium priority) may be si- lenced for 10 minute intervals by pressing this key XVIVO Perfusion System (XPS ) Instructions for Use -96- P/N: 9182-0189 Revision Q...

  • Page 97: C3 Ventilator

    Set date &/or time and select Apply to set 8.6.2 Main Screen Orientation:  Main monitoring parameters  P max  Pressure limitation (P max—10 cm H  Dynamic lung graphic XVIVO Perfusion System (XPS ) Instructions for Use -97- P/N: 9182-0189 Revision Q...

  • Page 98: Graphics Monitoring

    Select any of the graphic display options (‘Dynamic Lung’ here) 8.7.2 Dynamic Lung:  Lung image (this graphic shows a normal lung)  Numeric parameters  Bronchial tree graphic XVIVO Perfusion System (XPS ) Instructions for Use -98- P/N: 9182-0189 Revision Q...

  • Page 99: Dynamic Lung Compliance Graphics

    Moderately high resistance  High resistance 8.7.4 Dynamic Loop Display:  Dynamic loop waveform NOTE: The following dynamic loop waves can be displayed: • Pressure-Volume • Pressure-Flow • Flow-Volume XVIVO Perfusion System (XPS ) Instructions for Use -99- P/N: 9182-0189 Revision Q...

  • Page 100: Monitored Parameters

    Mean airway pressure. The absolute pressure, averaged over the breath cycle. Pmean (cmH20) Pmean is an important indicator of the possible impact of applied positive pressure on hemodynamics. XVIVO Perfusion System (XPS ) Instructions for Use -100- P/N: 9182-0189 Revision Q...
  • Page 101 Inspiratory tidal volume. The volume delivered to the lung. It is determined from the VTI (ml) Flow Sensor measurement. If there is a gas leak on the lung side, the displayed VTI may be larger than the displayed VTE. XVIVO Perfusion System (XPS ) Instructions for Use -101- P/N: 9182-0189 Revision Q...

  • Page 102: Smart Sequencing

    NORMAL Vt = <Normal VT> 12: END RECRUIT- ~61 min (Recruitment) PO2 < 40% Ended SETTINGS Rate = 7 MENT at 0 min Notice Oxygen = 21% XVIVO Perfusion System (XPS ) Instructions for Use -102- P/N: 9182-0189 Revision Q...
  • Page 103 SETTINGS Rate = 7 MENT at 0 min Notice Oxygen = 21% 4th Post ~240 100% of NORMAL Recruitment (NONE) (NONE) 28: EXTENDED EVLP minutes SETTINGS Perfusion XVIVO Perfusion System (XPS ) Instructions for Use -103- P/N: 9182-0189 Revision Q...

  • Page 104: Events Page

    HISTORY LOG Each case run on the XPS contains a HISTORY log. The log is a list of sequential inputs, events, and notifications that occur throughout the case. A HISTORY log file is created and permanently stored for each case on the XPS’s main computer. Copies of this file can be download- ed to an external drive (per instructions) or automatically transferred and processed by XMAT (if present).

  • Page 105: Trend Log Data

    Barometric Press Comm Status Status Index 0 = Off, 1 = On PA pH Status PA pH Comm Status Status Index 0 = Off, 1 = On XVIVO Perfusion System (XPS ) Instructions for Use -105- P/N: 9182-0189 Revision Q...
  • Page 106 1 = if both disconnected from wall power AND the UPS is communicating Battery SOC UPS Battery State of Charge Integer from 0 to 100 that represents the percentage of the battery’s charge XVIVO Perfusion System (XPS ) Instructions for Use -106- P/N: 9182-0189 Revision Q...

  • Page 107: Chapter 9 Appendix 2 Cleaning & Maintenance

    This Appendix 2 provides equipment maintenance on the XPS System as a whole and its individual parts. This section includes maintenance tasks that are easily performed by the end user. More complex maintenance tasks not included in this section should be referred onto XVIVO to schedule a service call visit.

  • Page 108: Cardiohelp Xvivo

    Maintenance and repairs may only be carried out by an authorized XVIVO service technician. This device as well as the entire XPS Cart should be serviced every 12 months by an authorized XVIVO service technician. The service technician will handle hazardous material disposal (including but not limited to batteries) according to accepted protocol.

  • Page 109: Heater/Cooler

     Place the tubing into an OR basin.  Press the Add/Remove Pumps button on XPS Touch screen to activate Add & Remove STEEN Solution menu. Press and hold Add button until water is drained from heater/cooler reservoir (approx.

  • Page 110: C3 Ventilator

    Maintenance and repairs may only be carried out by an authorized XVIVO service technician. This device as well as the entire XPS Cart should be serviced every 12 months by an authorized XVIVO service technician. The service technician will handle hazardous material disposal (including but not limited to batteries) according to accepted protocol.

  • Page 111: Perfusate Gas Monitor (Pgm)

    9.4.2 Maintenance & Service: Maintenance and repairs may only be carried out by an authorized XVIVO service technician. This device as well as the entire XPS Cart should be serviced every 12 months by an authorized XVIVO service technician. Category...

  • Page 112: Xvivo Perfusion Cart

    NOTE: No User Serviceable Parts Inside The entire XPS Cart should be serviced every 12 months by an authorized XVIVO service technician. The service technician will handle hazardous material disposal (including but not limited to batteries) according to accepted protocol.

  • Page 113: Chapter 10 Appendix 3 Technical Data

    This final Appendix 3 provides technical and safety data on the XPS System as a whole and its individual parts. Appendix 3 Technical Data CardioHelp XVIVO Quadrox-iR Oxygenator Heater/Cooler C3 Ventilator XVIVO PGM Sensors XPS Cart (Combined) Technical Specifications EMC Declarations...

  • Page 114: Cardiohelp Xvivo Technical Specifications

    140 VA AC power supply: Line Voltage 100 ... 240 V Frequency 50/60 Hz Line fuse 2 x T4.0A DC power supply Line voltage 11 ... 28 V XVIVO Perfusion System (XPS ) Instructions for Use -114- P/N: 9182-0189 Revision Q...
  • Page 115 Flow 0 ... 1 l/min +/-0.1 l/min +/- offset drift Flow > 1 l/min +/- 7% of the measured value +/- offset drift Offset drift Max. 0.03 l/m in 2 hours XVIVO Perfusion System (XPS ) Instructions for Use -115- P/N: 9182-0189 Revision Q...
  • Page 116 Pressures -500 ... 900 mmHg Warning: -/400 deactivated Alarm: —/500 -500 ... 900 mmHg Warning: -100/- deactivated Alarm: —150/- Δp -500 ... 900 mmHg Deactivated / 60 XVIVO Perfusion System (XPS ) Instructions for Use -116- P/N: 9182-0189 Revision Q...
  • Page 117 Time format hh:mm:ss, hh:mm hh:mm:ss 12 h, 24 h 24 h AVAILABILITY OF PHYSIOLOGICAL ALARMS FOR EXTERNAL DEVICES Physiological alarms are made available to external devices without delays. XVIVO Perfusion System (XPS ) Instructions for Use -117- P/N: 9182-0189 Revision Q...

  • Page 118: Technical Data:quadrox-Ir Disposable Oxygenator, Heat Exchanger And Centrifugal Pump

    1/4” Gas inlet connectors 1/4” Gas outlet connector 3/8” Size of water connector 1/2” Hansen coupling Sampling port at arterial outlet Luer lock Quick vent Luer lock XVIVO Perfusion System (XPS ) Instructions for Use -118- P/N: 9182-0189 Revision Q...

  • Page 119: Technical Data

    50 dB(A) (1m) Alarm level >65 dB(A) (3m) Quality Standards Medical Product Directive 93/42/EEC, IEC 601-1, IEC 601-1-2, IEC 601-2-35 II b Risk Class (93/42/EEC) 12-075 UMDNS Code XVIVO Perfusion System (XPS ) Instructions for Use -119- P/N: 9182-0189 Revision Q...

  • Page 120: C3 Ventilator Technical Specifications

    Approx. operating time under these condition are as follows: • One battery, display brightness = 80/20%: 3.5h/3.8 h • Two batteries, display brightness = 80/20%: 7h/8 h XVIVO Perfusion System (XPS ) Instructions for Use -120- P/N: 9182-0189 Revision Q...

  • Page 121: Control Setting Ranges And Resolutions

    0.01 s Based on rate (IBW) Tlow (APRV) 0.2-40 s 0.01 s Based on IBW Vt (tidal volume) 20-2000 ml 10% or 10 ml Based on IBW XVIVO Perfusion System (XPS ) Instructions for Use -121- P/N: 9182-0189 Revision Q...

  • Page 122: Parameter Ranges, Resolutions & Accuracies

    9.9 to 1:99 — fTotal 0-999 b/min ± 1 b/min TI, TE 0-60 s ± 0.1 s Other calculated and displayed parameters Cstat 0-300 ml/ cmH — XVIVO Perfusion System (XPS ) Instructions for Use -122- P/N: 9182-0189 Revision Q...

  • Page 123: Real-Time Curves And Loops

    X: 0 to 3200 ml; y: -10 to 80 cmH Volume/Flow X: 0 to 3200 ml; y:-300 to 300 l/min Pressure/Flow X: -300 to 300 l/min; y: -10 to 80 cmH XVIVO Perfusion System (XPS ) Instructions for Use -123- P/N: 9182-0189 Revision Q...

  • Page 124: Adjustable Alarm Ranges And Resolutions

    < 500 ml 50 ml ≥ 500 Note: The highlighted default settings are user-configurable. The items in the boxes represent the manufacturer’s recommended default settings for an in-vivo procedure. XVIVO Perfusion System (XPS ) Instructions for Use -124- P/N: 9182-0189 Revision Q...

  • Page 125: Other Technical Data

    Tightness test, oxygen cell calibration, Flow Sensor calibration, 100% O , manual breath, inspiratory hold maneuver, nebulization (30 min, 8 l/min), communications interface, com- pensation of breathing circuit resistance and compliance. XVIVO Perfusion System (XPS ) Instructions for Use -125- P/N: 9182-0189 Revision Q...

  • Page 126: Pgm (Monitor) Technical Specifications

    D x W x H 40 x 100 x 10.7 mm Dimensions (board) D x W x H 40 x 100 x 24 mm Weight 70 g XVIVO Perfusion System (XPS ) Instructions for Use -126- P/N: 9182-0189 Revision Q...

  • Page 127: Pgm (Sensors) Technical Specifications

    Parameter Specification Range 1-100% O Drift at 0% O (Stability) < 0.03% over 39 days (sample interval) Sterilization Gamma Calibration Pre-Calibrated Response time (t90) < 120 seconds XVIVO Perfusion System (XPS ) Instructions for Use -127- P/N: 9182-0189 Revision Q...

  • Page 128: Xvivo Perfusion Cart System Technical Specs

    Up to 6 bar/ 600kPa/ 87 psi Flow Up to 15 l/min STPD Connector 1/4” hose barb Inspiratory outlet Size 22mm male conical Expiratory outlet Size 22mm male conical XVIVO Perfusion System (XPS ) Instructions for Use -128- P/N: 9182-0189 Revision Q...

  • Page 129: Electrical Specifications

    Dynamic Compliance 0-999 P:F Ratio (calculated trend) 0– 800mmHg Insp time 0.00– 99.99 0– 2000 PERFUSATE GAS MONITOR 4.00– 11.00 0– 900mmHg WEIGHT SENSOR Mass 0– 9000g XVIVO Perfusion System (XPS ) Instructions for Use -129- P/N: 9182-0189 Revision Q...

  • Page 130: Notices

    PGMs &/or UPS User defined limits (default set at 7.0 for Low pH XPS Software will display an alarm state for All other alarms all equipment alarms covered in detail in chapters 5 and 6 of this IFU.
  • Page 131 In foreseeable electrical and mechanical interferences, the XPS works as intended within the stated accuracies. The XPS is intended for operation in the electromagnetic environment detailed below.

  • Page 132: Guidance And Manufacturer's Declaration Electromagnetic Immunity

    XVIVO Perfusion Cart System 10.8 Guidance and Manufacturer’s Declaration– Electromagnetic Immunity The XPS is intended for operation in the electromagnetic environment detailed below. The customer or the user of the device should ensure that it is used in such an environment.
  • Page 133 RF transmitters, an electromagnetic site survey is recommended. If the measured field strength in the location in which the XPS is used exceeds the applicable RF compliance level above, the XPS must be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the XPS.
  • Page 134 The carrier shall be modulated using a 50 % duty cycle square wave signal. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. XVIVO Perfusion System (XPS ) Instructions for Use -134-...
  • Page 135 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE XPS The XPS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the XPS can help to prevent electromagnetic interference by...

  • Page 136: Xps Accessories

    XPS Gas Bottle Bracket XVIVO Perfusion 9182-3433 XPS Cooling Basin XVIVO Perfusion 9182-3434 XPS X-Ray Support XVIVO Perfusion The following cable accessories, including maximum lengths are included with the XPS™: Part Number Cables/ Accessories Maximum Cable Manufactured by Lengths 9182-2633 Flow/Bubble Sensor Cable...

  • Page 137: Xps I/O Connections

    XPS I/O Connections The table below displays the I/O ports name and component connections used with the XPS™. The Touchscreen and Display- only monitors figures display the I/O ports name and component connection used (and not used) with the XPS™.

  • Page 138: Installation & Environmental Requirements

    XVIVO Representative. This section gives a basic indication of how the cart is unpacked only. To ensure the system functions properly, the equipment must be installed by an XVIVO Representative and the following conditions must be met: •...

  • Page 139: Revision History

    Instructions for Use for the original XPS System and the new version of the XPS System have been merged and are currently on Revision L. Below are the revision history for the original XPS System and the new version of the XPS System.
  • Page 140 Section 8.5.2: Added “NOTE: No User Serviceable Parts inside” General: Updated page numbers. 10/14/2014 Updated XPS System Alarms and Alerts to Notifications Updated Equipment Alarms and Alert System for Cardiohelp, Heater/Cooler and Ventilator Section 2.4.2: Added “Start Data Loggin” feature.
  • Page 141 06/29/2015 Instructions for Use for the original XPS System and the new version of the XPS System have been merged and are currently on Revision K. Therefore, Revisions C-J which apply to the new version of the XPS System, are obsolete.
  • Page 142 XVIVO Perfusion System (XPS ) Instructions for Use -142- P/N: 9182-0189 Revision Q...

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