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TransMedics Organ Care System Technical User Manual

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TransMedics
Organ Care System
®
™
Technical User Guide:
OCS
Lung System
TM
Software Version 3.1.2
PN 100004070 Rev 6
REF 2103
2797
© 2019 by TransMedics, Inc. All rights reserved. Printed in U.S.A.
PN 100004070, REV 6
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  • Page 1 TransMedics Organ Care System ® ™ Technical User Guide: Lung System Software Version 3.1.2 PN 100004070 Rev 6 REF 2103 2797 © 2019 by TransMedics, Inc. All rights reserved. Printed in U.S.A. PN 100004070, REV 6 Page 1...
  • Page 2 TransMedics Legal Department. This document is intended to be used by customers and is licensed to them as part of their TransMedics equipment purchase.

  • Page 3: Table Of Contents

    Using the Lung Preservation Gas Cylinders ................44 4.5. Using the Lung Monitoring Gas Cylinder ................48 4.6. Returning an EMPTY Gas Cylinder to TransMedics ..............50 4.7. Replacing a Yoke Gasket ......................51 4.8. Using the TransMedics Data Cards ..................51 4.9.
  • Page 4 Table of Contents CHAPTER 5: WIRELESS MONITOR OVERVIEW ................54 5.1. Wireless Monitor Components ....................54 5.2. Wireless Monitor Controls ..................... 55 5.3. Wireless Monitor Display Overview ..................56 CHAPTER 6: MANAGING THE SYSTEM ..................61 6.1. Managing Sessions ......................... 61 6.2.
  • Page 5 Table of Contents 9.13. Known Limitations of the OCS™ 3.1.2-C Software ............... 119 PARTS AND SUPPLIES ......................120 10.1. Contacting TransMedics ....................... 120 10.2. Ordering Parts and Supplies ....................120 APPENDIX A. SYMBOL GLOSSARY ..................... 124 PN 100004070, REV 6...

  • Page 6: Glossary Of Terms

    Glossary of Terms GLOSSARY OF TERMS Term Meaning Arterial Blood Gas Annotations Notes or comments entered through the Wireless Monitor during the session that are automatically stamped with the time of entry and saved in the session file. Breaths/minute Bronchoscope Ventilation of the lungs with ambient air, to allow examination of the interior of the lungs with a Mode Bronchoscope.
  • Page 7 With the Mobile Base removed, you can set the system flat or carry it with the lift handles. Organ Care System The Organ Care System (OCS™) houses the removable Wireless Monitor, circulatory pump driver, multi- mode Ventilator drive and control, batteries, data card, gas delivery subsystem, and reusable flow and pulse oximeter probes.
  • Page 8 Glossary of Terms Term Meaning Oxygen saturation of arterial (oxygenated) perfusate, expressed as a percentage and measured at the output of the lung at the LA drain. Hematocrit An OCS™ Lung Console probe that you attach to the Lung Perfusion Module. It is used to measure the Probe arterial oxygen saturation and the hematocrit of the perfusate leaving the lung through the LA.

  • Page 9: Chapter 1: Read This First

    TransMedics Clinical User Guide: OCS™ Lung System. Both guides are to be reviewed prior to using the system, noting the Warnings and Cautions throughout the guides.
  • Page 10 Chapter 1: Read This First • All step-by-step procedures are numbered, and all sub-procedures are lettered. You must complete steps in the sequence they are presented to ensure success. • Bulleted lists indicate general information about a particular function or procedure. They do not imply a sequential procedure.

  • Page 11: Upgrades And Updates

    Only accessories and supplies purchased from or recommended by TransMedics, Inc. are to be used with the OCS™ Lung System. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause system malfunction and invalidate the TransMedics warranty.

  • Page 12: Chapter 2: Safety Information

    Never use a converter adapter to plug the three-pronged AC plug into a two-pronged ungrounded wall outlet. Doing so may result in electric shock to the operator and damage to the equipment. To avoid electrical shock, use only the power cords supplied by TransMedics for the OCS™, and connect only to properly grounded wall outlets.

  • Page 13: Mechanical And System Safety

    CAUTIONS— Use only accessories and supplies purchased from or recommended by TransMedics. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause organ damage and will invalidate the TransMedics warranty. (This manual details approved accessories and supplies as relevant to system operation.) Do not attempt to sterilize the OCS™...
  • Page 14 Do not use the system and accessories in the presence of explosive anesthetics. Only a qualified TransMedics Service representative may service the system or any of its accessories. Any attempt by the user to disassemble the OCS™ or any of its accessories may result in shock or serious injury and will void the warranty.

  • Page 15: Patient And Organ Safety

    If necessary, adjust fluid temperature accordingly to accommodate external temperatures. Use only accessories and supplies purchased from or recommended by TransMedics. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause organ damage and will invalidate the TransMedics warranty. (This manual details approved accessories and supplies as relevant to OCS™...
  • Page 16 Chapter 2: Safety Information Table 2-1: Symbols Used on the Lung Perfusion Module and Lung Console Symbol Meaning Symbol Meaning Indicates On (only for a part of Indicates Off (only for a part of the the equipment) equipment) Run/Standby Non-ionizing, electromagnetic radiation Direct current Alternating current Bronchoscope Port...

  • Page 17: Using Aseptic Technique

    WARNINGS— Failure to follow any of these precautions may result in injury and/or damage to the TransMedics OCS™ and its contents. Disconnect the system power cord from the wall outlet and wind it snugly around the power cord wrap before moving the system.

  • Page 18: Storing The System Between Uses

    Wheel brakes are only meant to stop forward movement of the OCS™ Lung Console but the device can move backwards with brakes engaged. TransMedics recommends attention to outside temperature; low temperatures can accelerate battery depletion. When moving the system outside, be sure to keep the OCS™ top cover in place to conserve energy.

  • Page 19: Shipping, Handling And Storage Requirements

    Chapter 2: Safety Information 2.10. Shipping, Handling and Storage Requirements Figure 2-1: Shipping, Handling, and Storage Requirements Symbols Unless otherwise noted the OCS™ and its accessories have the following shipping, handling and storage requirements: 1. 10% to 95% Humidity Limitation 2.

  • Page 20: Explosion Hazard

    Wireless Monitor. NOTE— The Wireless Monitor battery can be serviced and replaced only by qualified TransMedics Service Personnel. To use the OCS™ Lung Console to recharge the system and Wireless Monitor batteries, the system must be connected to AC power and the On/Off switch must be in the On position.

  • Page 21: Handling Pressurized Gas Cylinders

    Do not attempt to recharge the batteries by methods other than within the OCS™ Lung Console. Doing so may cause a fire or damage equipment. For long-term storage, store extra OCS™ batteries in the original shipping containers from TransMedics. Lithium batteries must be packaged for shipment by qualified personnel and shipped according to applicable transportation laws in the original packaging or replacements supplied by TransMedics.

  • Page 22: Disposal Of The System And Components

    Gas Cylinder.” For details on returning empty gas cylinders to TransMedics, see Section 4.6 “Returning an EMPTY Gas Cylinder to TransMedics.” CAUTION— Use ONLY this packaging or a replacement supplied by TransMedics. Other containers may not sufficiently protect the cylinder from potential damage during shipment and may not meet regulatory requirements. 2.17.

  • Page 23: Chapter 3: Overview

    Only accessories and supplies purchased from or recommended by TransMedics are to be used with the OCS™. Use of accessories and supplies other than those supplied by or recommended by TransMedics may cause system malfunction and invalidate the TransMedics warranty.

  • Page 24: Ocs™ Lung System

    Chapter 3: Overview • Gas Cylinders − Lung Preservation Gas Cylinders − Lung Monitoring Gas Cylinders • Flow probe (Pump) • SvO /Hematocrit Probe • SaO /Hematocrit Probe • Lung Monitoring Gas Regulator Kit 3.1.2. Items Included with the Lung Perfusion Set Each Lung Perfusion Set is shipped with the necessary sterile components required during a lung preservation session.
  • Page 25 Chapter 3: Overview Figure 3-1: OCS™ Lung System (with Covers) PN 100004070, REV 6 Page 25...
  • Page 26 Chapter 3: Overview Figure 3-2: OCS™ (with Covers Removed) 3.2.1. Wireless Monitor The Wireless Monitor (as shown in Figure 3-1) tracks the vital functions of an organ perfused with the OCS™ and displays organ- and system-functional parameters. You can use the Wireless Monitor while it is docked on the OCS™...
  • Page 27 OCS™ Probes The pump flow probe measures the flow rate of perfusate within the Lung Perfusion Module circuit. The TransMedics non-invasive SvO /Hematocrit probe monitors both blood hematocrit (percentage of red blood corpuscles to whole blood volume) and blood oxygen saturation (percentage of oxyhemoglobin to total hemoglobin).
  • Page 28 Chapter 3: Overview 3.2.4. Lung Monitoring Gas Cylinders Figure 3-5: Lung Monitoring Gas Cylinder Lung Monitoring Gas is used during Monitoring Modes (described in Section 3.4.1, “OCS™ Lung System Perfusion and Ventilation Circuit.”). Each cylinder holds 408 L at 3000 psi (21000 kPa). For details on estimating the remaining Lung Monitoring Gas, see Table 4-2.

  • Page 29: Lung Perfusion Set Components

    NOTES— When the OCS™ is in Standby mode and not connected to AC power, the batteries will deplete. TransMedics recommends connecting the OCS™ to AC power whenever possible. When the OCS™ is connected to AC power and not operational, it can take up to 12 hours to fully recharge all three discharged OCS™...
  • Page 30 Chapter 3: Overview • Integrated low shear titanium perfusate warmer • Integrated gas exchanger • Integrated ventilator interface • Integrated sensors (pressure and temperature) and communication circuitry. Figure 3-7 shows the front view of the Lung Perfusion Module and its components. Figure 3-7: Lung Perfusion Module - Front View PN 100004070, REV 6...
  • Page 31 Chapter 3: Overview Figure 3-8 shows the left side of the Lung Perfusion Module. Figure 3-8: Lung Perfusion Module - Left Side View Figure 3.9 shows the back view of the Lung Perfusion Module and its components. Figure 3.9: Lung Perfusion Module - Back View PN 100004070, REV 6 Page 31...
  • Page 32 Chapter 3: Overview Figure 3-10 shows the top view of the Lung Perfusion Module. Figure 3-10: Lung Perfusion Module Top View (with chamber cover open) Figure 3-11 shows the right-side view of the Lung Perfusion Module. Figure 3-11: Lung Perfusion Module Right Side View PN 100004070, REV 6 Page 32...
  • Page 33 3.3.2. Lung Perfusion Initiation Set Use the TransMedics Lung Perfusion Initiation Set (Figure 3-13) at the beginning of the perfusion procedure. The set includes two Dual-Vented Prime Lines for adding bagged or bottled solutions. The prime lines include a filter to remove particulate matter from pooled packed red blood cell units (pRBCs) that may be used to prime the circuit.
  • Page 34 Chapter 3: Overview 3.3.3. Lung Instrumentation Tool Set The Lung Instrumentation Tool Set (Figure 3-14) includes sterilized accessories for instrumenting the lung to the OCS™. Select the accessory size most appropriate for the Donor lung. For details about the use of each item in the set and specific sizes and styles available, see Table 3-1.

  • Page 35: Overview Of Use

    3.3.4. Lung Perfusion Termination Set Use the TransMedics Lung Perfusion Termination Set at the end of the perfusion procedure. The set includes a drainage bag for removing solution from the OCS™. TransMedics recommends using a single 3 Liter bag of termination flush solution for the final flush.
  • Page 36 Monitoring - Continuous Lung Monitoring Gas Gas Exchanger Monitoring - Bronchoscope Room Air Lung For more details about the usage of Preservation and Monitoring Modes, see the TransMedics Clinical User Guide: OCS™ Lung System. PN 100004070, REV 6 Page 36...
  • Page 37 Chapter 3: Overview Figure 3-16: Circulation and Ventilation 3.4.3. Valves and Ports The Lung Perfusion Module includes manual valves and ports (refer to Figure 3-7) for various interventions that may be required when managing the organ throughout the phases of preservation. NOTE—...
  • Page 38 Chapter 3: Overview • A Termination Flush port lets you flush the lung before removing it from the OCS™. • A Bronchoscope port lets the user insert a bronchoscope into the lung airway through the trachea connection. The port cap includes resealable peel-away adhesive fasteners to ensure the port cap is secured when not in use.

  • Page 39: Chapter 4: System Setup And Connections

    On/Off switch will completely disconnect power. Do not use the OCS™ and accessories in the presence of explosive anesthetics. To avoid electrical shock, use only the power cords supplied by TransMedics for the OCS™, and connect only to properly grounded wall outlets.

  • Page 40: Checking Battery Power

    Chapter 4: System Setup and Connections 4.1.1. To connect the system to AC power 1. Connect the power cord to the recessed power inlet receptacle located above the power cord wrap (Figure 4-1). 2. If necessary, unwind the power cord from the power cord wrap. 3.
  • Page 41 • If the lower LED flashes and the remaining four LEDs are not illuminated, it indicates that the battery is fully discharged. Replace the battery with a fully charged battery or connect the OCS™ to AC power. • If no LEDs light, do not use the battery and contact TransMedics service (+1-978- 552-0999). Figure 4-3: OCS™ Batteries 4.2.3.

  • Page 42: Docking And Undocking The Wireless Monitor

    Table 5-3. NOTES— If you will not be immediately recharging the removed battery, return it to the original TransMedics shipping container for storage. For details on storing batteries, see Chapter 8: System Specifications. If you need to ship OCS™ batteries, they must be packaged for shipment by qualified personnel and shipped according to applicable transportation laws in the original shipping packages or replacements supplied by TransMedics.
  • Page 43 Chapter 4: System Setup and Connections Figure 4-4: Docking the Wireless Monitor 4.3.1. To dock the Wireless Monitor 1. Position the Wireless Monitor so that its grooves line up with the rails on the system (Figure 4-4). 2. Slide the Wireless Monitor all the way into the Monitor docking cradle, until the receptacle on the Monitor locks into the connector on the system.

  • Page 44: Using The Lung Preservation Gas Cylinders

    Chapter 4: System Setup and Connections During remote operation, all controls operate normally except the Run/Standby button ( ) which functions only when the Wireless Monitor is docked to the system. The Run/Standby button lets you transition the OCS™ from an inactive state (Standby) to an active state (Run). If the Wireless Monitor is moved out of range of the system, a warning tone emits and continues until the connection is re-established.
  • Page 45 Chapter 4: System Setup and Connections Table 4-1: Hours of Lung Preservation Gas Supply Remaining at Various Flow Rates and Cylinder Pressures Pressure Flow Rate (ml/min) (psi) 1000 Hours Remaining Based on Pressure (psi) and Flow Rate 3000 32.3 21.5 16.2 12.9 10.8...
  • Page 46 Chapter 4: System Setup and Connections Figure 4-6: Lung Preservation Gas Cylinder and Regulator NOTE— You cannot remove the cylinder at this point because the regulator fittings and gauge are attached to the cylinder and are permanently connected inside the compartment. 5.
  • Page 47 Chapter 4: System Setup and Connections 4.4.2.2. To install a new Lung Preservation Gas cylinder 1. Remove the Lung Preservation Gas cylinder from the packaging, and remove the shrink-wrap packed around the valve, and then remove the white plastic plug. NOTE—...

  • Page 48: Using The Lung Monitoring Gas Cylinder

    Chapter 4: System Setup and Connections 8. Push the cylinder all the way into the cylinder compartment. 9. Return the wrench to its location on the wrench mount in the gas cylinder compartment, so that it will be available for the next use (see Figure 4-7). 10.
  • Page 49 Chapter 4: System Setup and Connections NOTE— Discard the shrink-wrap and plastic plug, but be sure to KEEP the other packaging to use when returning empty cylinders for refill. 2. Make sure that the regulator’s yoke gasket is in place and undamaged (Figure 4-8). If the gasket appears to be damaged, remove it and replace it as described in Section 4.7, “Replacing a Yoke Gasket.”...

  • Page 50: Returning An Empty Gas Cylinder To Transmedics

    Open the valve slowly. Opening it quickly or any further than 1/4 turn may cause the gas cylinder to move rapidly from its current location, which may result in bodily injury and property damage. Use ONLY packaging or a replacement packaging supplied by TransMedics. Other containers may not sufficiently protect the cylinder from potential damage during shipment, and may not meet regulatory requirements.

  • Page 51: Replacing A Yoke Gasket

    CAUTION— Use only data cards supplied by TransMedics. Other data cards will not function properly with the OCS™ and may cause a disruption of OCS™ operation. NOTE—...

  • Page 52: Using The Mobile Base

    Chapter 4: System Setup and Connections Figure 4-10: Data Card and Installation Slot 4.8.1. To install a data card 1. With the system top cover removed, locate the data card slot at the back of the system at the top right of the Wireless Monitor docking area (Figure 4-10).

  • Page 53: Lung Perfusion Module Preparation

    7. When ready to move the system, lift the wheel locks to unlock the wheels, and set the push handle to the up position. 4.10. Lung Perfusion Module Preparation For details about installation and priming of the Lung Perfusion Module, see the TransMedics Clinical User Guide: OCS™ Lung System. PN 100004070, REV 6 Page 53...

  • Page 54: Chapter 5: Wireless Monitor Overview

    Chapter 5: Wireless Monitor Overview CHAPTER 5: WIRELESS MONITOR OVERVIEW The Wireless Monitor tracks the vital functions of an organ preserved with the OCS™ Lung System and displays organ and system parameters. You can use the Wireless Monitor while it is docked on the OCS™ Lung System or you can remove it (undock it) and use it remotely, such as when transporting the organ.

  • Page 55: Wireless Monitor Controls

    Chapter 5: Wireless Monitor Overview Wireless Monitor Description For more information, see: Component Status Icons The status icons that appear along the bottom row of the Wireless "System Status Icons on the Monitor screen help you quickly determine information about the Wireless Monitor,"...

  • Page 56: Wireless Monitor Display Overview

    Chapter 5: Wireless Monitor Overview Table 5-2: Wireless Monitor Controls Control Name Description Run/Standby Press this button to transition between Run Mode and Standby Mode. Note: This button can Button only be used when the Wireless Monitor is docked on the OCS™ Lung Console. If the Wireless Monitor is not docked, pressing this button has no effect.
  • Page 57 Chapter 5: Wireless Monitor Overview 5.3.2. Organ Parameter Frames Organ parameter values are displayed in the frames on the left side of the Wireless Monitor, as shown in Figure 5-1. Organ parameter values include: • PF: Pump Flow in L/min •...
  • Page 58 Chapter 5: Wireless Monitor Overview 5.3.3. Graphical Frames The main center section of the Wireless Monitor (Figure 5-5) displays up to three graphical frames to help you quickly determine parameter information and to view trend data. Figure 5-5: Graphical Frames Each time you change modes during the session, the graphical frames that you configure for that mode are automatically displayed on the Wireless Monitor.
  • Page 59 Chapter 5: Wireless Monitor Overview Icons Description Lung Preservation Gas Capacity Alarm: Activates with 60 minutes of estimated remaining gas consumption time and displays estimated gas remaining time as gas depletes. Lung Preservation Gas Fault Alarm Organ Icons Preservation Mode A “p”...
  • Page 60 Chapter 5: Wireless Monitor Overview Icons Description Wireless Fault Generic System Fault Generic system fault. This icon appears on the lower right corner of the Wireless Monitor display. Refer to the Alarm Banner at the top of the display for further information about the issue and instructions. PN 100004070, REV 6 Page 60...

  • Page 61: Chapter 6: Managing The System

    OCS™ to AC power whenever possible. Batteries will not charge if the On/Off button is set to the Off position. TransMedics recommends leaving the On/Off button set to the On position at all times except when the device must be powered down for service or cleaning.
  • Page 62 When you insert the data card, the latest state of the session files for the current session is copied to the card. TransMedics recommends that you insert a data card at the beginning of each session. NOTE—...

  • Page 63: Using The Configuration And Action Menus

    While a data transfer is in progress, the data card status icon is displayed with a green arrow. To avoid data loss or corruption, do not remove the card while the transfer is in progress. 1. Insert the TransMedics data card into the card slot. All available data from the current session is automatically transferred to the card.
  • Page 64 Chapter 6: Managing the System Figure 6-1: Configuration Menu Resting Tab 6.2.1. To display and use the Configuration Menu 1. Press to display the Configuration Menu. 2. To select a tab, turn the rotary knob to highlight one of the tabs. 3.

  • Page 65: Configuring Session Settings

    Chapter 6: Managing the System Action Description Copy Last Five Sessions Copies only the most recent five session folders to the external SD card. Copy All Sessions Copies all session folders to the external SD card. Scale RESP Lets you switch between fixed waveform scales (airway pressure and PA pressure) or use auto- scaling.
  • Page 66 Monitoring Mode tab also provides the selections as described in Table 6-6. NOTE— The default values for these parameters have been established for clinical use. Configuration values should only be set per TransMedics clinical training. 6.3.3. Configuring Alarms Use the Perfusion Alarms and Ventilator Alarms windows (Figure 6-3) to set the alarm limits on the perfusion and ventilation parameters in the Preservation Mode and Monitoring Modes.
  • Page 67 Chapter 6: Managing the System NOTE— Table 6-3 and Table 6-4 list the Alarm Limit Configurations for Preservation and Monitoring Modes. Most parameters listed have a high and low limit. However, TV and RR work slightly differently. The limits are not hard numbers, but are percentages of the set-point.
  • Page 68 Chapter 6: Managing the System Configuration Factory Default Step Units The software displays “dynes” as an abbreviation for the VR units which are (dyne*s)/cm Percentage of the configured set point in BPM. Percentage of the configured set point in mL. Table 6-4 lists the Perfusion and Ventilator alarm limit configurations for Monitoring Mode.
  • Page 69 Chapter 6: Managing the System 6.3.4. Setting the Lung Preservation Gas Flow Rate Use the Gas Flow Rate field of the Configuration Menu to configure the amount of Lung Preservation Gas that is delivered to the perfusate through either the gas exchanger during Preservation Pause Mode, or directly to the lungs in Preservation Mode.

  • Page 70: Configuring System Settings

    You cannot change the blood sample units once a blood sample has been added for the current session. The Toggle wireless console menu item in the System tab is a TransMedics service function and is not user-accessible. PN 100004070, REV 6...

  • Page 71: Managing Default Configuration Settings

    Chapter 6: Managing the System 6.5. Managing Default Configuration Settings This section provides information and instructions for saving default settings and restoring system settings. It also lists the system parameters, ranges, and factory default values. 6.5.1. Saving Default Settings Use the Save as Defaults field of the System tab of the Configuration Menu to save the current Preservation Mode, Monitoring Mode, and system settings as the session default.
  • Page 72 Chapter 6: Managing the System Parameter Range of User-Configurable Defaults Factory Default Top Graphic Frame Always airway pressure real-time waveform Not configurable Middle Graphic Frame Primary Parameter Real-time waveform options: PAP PAP Real-Time Trend graphic waveform options: PF, VR, SvO , SaO , HCT, Temp, RR, TV, PAWP, PEEP, PAP, Monitoring...
  • Page 73 Chapter 6: Managing the System Parameter Range of User-Configurable Defaults Factory Default Plateau Time Set Point 0.3 to 2.0 seconds 0.3 seconds Top Graphic Frame Always airway pressure real-time waveform Not configurable Middle Graphic Frame Primary Parameter Real-time waveform options: PAP PAP Real-Time Trend graphic waveform options: PF, VR, SvO , SaO...

  • Page 74: Adjusting The Pump

    Chapter 6: Managing the System 6.5.6. Blood and Perfusate Sample Analyte Data Table 6-8 lists the parameters, range, and units for the blood and perfusate analyte data that can be entered into the system. Table 6-8: Blood and Perfusate Sample Analyte Data Parameter Range Lactate...

  • Page 75: Managing Alarms

    Chapter 6: Managing the System CAUTION— Perfusate warming and gas flow are enabled only when the pump is on (or faulted). Setting the pump to OFF turns off the pump, the gas, the ventilator, and the perfusate warmer. When the pump flow is off, physiological parameter alarm monitoring is disabled.
  • Page 76 Monitor such that they can view it at all times. Table 6-9 summarizes the indicators that may occur during system operation. System faults that may require TransMedics service are listed in Chapter 9: Troubleshooting. Table 6-9:...
  • Page 77 Chapter 6: Managing the System 6.7.2. Visual Alarm Indicators Alarm messages are displayed in the Alarm Banner in different colors to indicate the priority: High Priority alarms appear in red, Medium in yellow, and Low priority/informational alarms appear in blue. The item associated with the alarm flashes on the Wireless Monitor to help you quickly identify the issue and respond accordingly.

  • Page 78: Managing Real-Time Waveforms

    Chapter 6: Managing the System • Capacity alarms are silenced for five minutes; physiological alarms are only silenced for one minute; system fault alarms are silenced indefinitely. 6.7.5.2. To disable alarm tones Press and hold to disable all audible alarm tones indefinitely. Visual alarm indications continue to display. If the pump is on, the Wireless Monitor also emits a beep every 2 minutes and a message is displayed in blue on the Alarm Banner to remind you that the audio alarm is off.
  • Page 79 Chapter 6: Managing the System 6.8.2. Pressure Waveform Data Scaling Methods Real-time pressure waveforms may be scaled automatically or manually. 6.8.3. Auto-Scaled Pressure Waveform Data The OCS™ supports auto-scaling of pressure waveforms. When auto-scaling is enabled, the y-axis range changes automatically as the displayed pressure data changes. Arrow icons are displayed at the top and bottom of the y-axis scale when this mode is active (Figure 6-8).

  • Page 80: Managing Historical Trend Graphs

    Chapter 6: Managing the System 3. With the selected scale flashing, do any of the following: • To select the next larger scale limit for that waveform, turn the knob clockwise. • To select the next lower scale limit, turn the knob counterclockwise. •...
  • Page 81 Chapter 6: Managing the System All available trend data is saved with the session file. For detailed instructions on configuring trend graphs to display on the Wireless Monitor, see Section 6.3.5, “Configuring Graphic Frames.” 6.9.1. Using Scrolling and Cursor Mode When scrolling through a trend, each click of the knob represents approximately 30 minutes of data, with the screen showing about 3½...

  • Page 82: Starting And Resetting The Perfusion Clock

    Chapter 6: Managing the System 6.10. Starting and Resetting the Perfusion Clock The perfusion clock tracks how long the lung has been perfused on the OCS™. This section provides information about the perfusion clock and instructions for starting and resetting the clock. CAUTION—...
  • Page 83 Chapter 6: Managing the System Figure 6-12: Blood Sample Input Window 6.11.1.1. To add blood and perfusate sample data 1. Press 2. Rotate the knob to highlight Add Blood Sample and press the knob. The Blood Sample Input window is displayed (Figure 6-12).
  • Page 84 Chapter 6: Managing the System 6.11.2. Editing and Deleting Blood Sample Data Use the Action Menu to edit and delete blood and perfusate sample entries taken during the session. You can scroll through the sample entries by the time stamp entered for each entry. NOTE—...

  • Page 85: Using Annotations

    Chapter 6: Managing the System 6.12. Using Annotations You can add notes and comments during the preservation session as Annotations. You can also use the Annotation Menu through the Action Menu to enter an organ identifier to be included in the session files. Annotations are automatically stamped with the time of entry and saved in the session file.
  • Page 86 Chapter 6: Managing the System 3. Press the knob. The first available key word appears to the right of Key Word List and temporarily between the two thick lines. 4. Turn the knob to display each available word or phrase. 5.

  • Page 87: Calibrating The Sao /Hct Probe

    Calibrating the SaO /HCT Probe The SaO and SvO probes have been calibrated at the factory before the OCS™ was installed. If directed by TransMedics to recalibrate the probes, follow these steps. 6.13.1. To calibrate the SaO /HCT probe 1. Press 2.

  • Page 88: Displaying System Status

    The Display Status item in the Actions tab of the Configuration Menu lets you quickly review the current status of system components and settings. This function is also useful when communicating system information to TransMedics. PN 100004070, REV 6 Page 88...

  • Page 89: Chapter 7: Cleaning And Maintaining The Ocs

    WARNING— Only a qualified TransMedics Service representative may service the TransMedics OCS™ Lung System or any of its accessories. Any attempt by the user to disassemble the system or any of its accessories may result in shock or serious injury and will void the warranty.

  • Page 90: Infection Control

    Chapter 7: Cleaning and Maintaining the OCS If you find any damage, contact TransMedics Service. 7.2. Infection Control For protection of both staff and patients, always follow institutional infection control procedures when setting up, using, and cleaning the OCS™. 7.3.
  • Page 91 Chapter 7: Cleaning and Maintaining the OCS • 70% isopropyl alcohol swabs • Tongue depressors • Soft lint-free cloths • Lint-free swabs • Disposable soft brushes (e.g., 3/8” horse hair brush from Tanis, part number 02001) • Paper towel • Water 7.4.3.
  • Page 92 6. If the surface oxidation still exists, thoroughly scrub the seal.) silver button with Diamond Paste Metal Cleaner supplied by TransMedics (REF 1460) for 10 seconds using a lint-free PN 100004070, REV 6 Page 92...
  • Page 93 Chapter 7: Cleaning and Maintaining the OCS Area Supplies Exposure time Cleaning Procedure wipe. Wipe the silver button and Circuit Board Connector Block clean with alcohol wipes and lint-free wipes. 7. Inspect the strip of gold tape below the silver buttons for signs of peeling.
  • Page 94 Chapter 7: Cleaning and Maintaining the OCS Area Supplies Exposure time Cleaning Procedure Water 3. After second exposure time, remove the excess of disinfectant with a soft lint-free cloth moistened with water and then dry. Wireless Monitor Alcohol wipes 5 minutes DO NOT ALLOW CONNECTOR PINS TO GET WET.
  • Page 95 Chapter 7: Cleaning and Maintaining the OCS Area Supplies Exposure time Cleaning Procedure Screen, rotary knob, Alcohol wipes 5 minutes 1. Wipe with alcohol wipes and swabs. keypad, black side (twice) Alcohol swabs 2. Repeat after first 5-minute exposure time has elapsed. rails Soft lint-free cloths 3.

  • Page 96: Cleaning And Disinfecting The Probes

    Chapter 7: Cleaning and Maintaining the OCS CAUTIONS— Sterilization (by any means) is not allowed for any component of the OCS™. Do not use any disinfection agents other than those prescribed in this manual. Doing so may lead to component damage, interfering with proper system operation.

  • Page 97: Cleaning And Maintenance Task Checklist

    Cleaning and Maintenance Checklist Activity Frequency Comment Shipment inspection Upon receipt of TransMedics System or Visual inspection individually purchased TransMedics components and supplies, and prior to and after each use and at least once a month during storage. Routine cleaning...
  • Page 98 Ground integrity test Once a year or as required by the institution. By institutional biomedical engineer according to institution’s procedures. (Table 2-2 lists the safety test guidelines.) Preventive Maintenance Once a year By TransMedics Service PN 100004070, REV 6 Page 98...

  • Page 99: Chapter 8: System Specifications

    Chapter 8: System Specifications CHAPTER 8: SYSTEM SPECIFICATIONS This chapter lists and describes the following specifications for the TransMedics OCS™ Lung System. ® • Safety and Regulatory Specifications • Electrical and Physical Specifications • Electromagnetic Emissions: Guidance and Manufacturer’s Declaration •...

  • Page 100: Electromagnetic Emissions

    Chapter 8: System Specifications Table 8-2: OCS™: Electrical and Physical Specifications Parameter Specification System Power Input - AC Line input voltage: IEC power inlet receptacle 100 to 240V, 50-60Hz, 375VA OCS™ Battery 14.8 V 15 Ah Wireless Monitor Battery 7.2 V 12 Ah Operating Conditions Temp Range: 15°C to 35°C (59°F to 95°F) Relative Humidity (non-condensing, steady state):...
  • Page 101 EMC information provided in this document. WARNINGS— Use of accessories and cables other than those specified, with the exception of cables sold by TransMedics, Inc., as replacement parts for internal components may result in increased emissions or decreased immunity of the OCS™.
  • Page 102 Chapter 8: System Specifications Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Radiated RF IEC 61000- 3 V/m 3 V/m 80 MHz to 800 80 kHz to 2.7 GHz 80 kHz to 2.7 GHz 80 % AM at 1kHz 80 % AM at 1kHz 800 MHz to 2.7 where P is the maximum power in...

  • Page 103: Essential Performance

    Chapter 8: System Specifications Table 8-5: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the OCS™ Rated maximum output Separation distance according to frequency of transmitter in meters for V =3Vrms and E power of transmitter =3 V/m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz...

  • Page 104: Chapter 9: Troubleshooting

    Technical Service to be performed on the equipment after the perfusion run is completed. Technical Service is available via email at service@transmedics.com, or by calling +1 978 552 0999, ext 2. Depending on the cause of the issue, different Technical Service response may be indicated: •...

  • Page 105: Power-Cycling The System

    6. After ensuring adequate inflation, apply a sterile clamp to the tracheal cannula and disconnect the manual inflation bag. Keep the trachea clamped inside the organ chamber until the final flush. 7. Perform the final lung flush procedure as described in the TransMedics Clinical User Guide: OCS™ Lung System.
  • Page 106 Chapter 9: Troubleshooting Table 9-1: Troubleshooting Pumping Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: Pump Failure 1. Remove and reinsert LPM. Turn pump off and attempt to 1. Perform Early Termination Standby-cycle the system.
  • Page 107 2. Standby-cycle the system. 3. Replace the LPM. (If a Single blood replacement LPM is not available, warmer sensor contact TransMedics for failure instructions on how to proceed with organ perfusion.) Single blood 1. Turn off the ventilator, remove 1.
  • Page 108 2. 2. Standby-cycle the LPM is not available, contact Airway system. 2. Perform Early TransMedics for instructions on how to Termination Procedure. proceed with organ perfusion.) Then follow-up with OCS™ Service. Pressure probe 1. Turn off the ventilator, and unlatch and failure: Single PAP latch the LPM.
  • Page 109 Check the circuit for value displayed LPM is not available, contact or blockage. kink or blockage. for PAP or RESP TransMedics for instructions on how to 2. Perform Early Replace the LPM. proceed with organ perfusion.) Termination Procedure. Then follow-up with Service.
  • Page 110 Chapter 9: Troubleshooting Table 9-7: Troubleshooting the Flow Probes Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: Check flow 1. Check for air in the line. 1. Check for air in the line. 1.
  • Page 111 Chapter 9: Troubleshooting Table 9-9: Troubleshooting SaO /HCT Probe Calibration Issues Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: /HCT probe 1. Ignore this message until 1. After red blood cells have been 1.
  • Page 112 Chapter 9: Troubleshooting Table 9-10: Troubleshooting the Wireless Monitor Communications Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: Loss of wireless 1. Return the Wireless Monitor in 1. Return the Wireless Monitor in communication.
  • Page 113 Chapter 9: Troubleshooting Table 9-11: Troubleshooting the Power Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: Power system 1. Power-cycle the system. 1. Operate the OCS™ on failure battery power only 2.
  • Page 114 Chapter 9: Troubleshooting Message Recommended Action(s) If Detected During Self If Detected During Priming: If Detected After Organ is Test/LPM Insertion: Instrumented: Battery failure, 1. Remove right battery from service, replace battery with a spare 1. Remove battery from use, remove battery battery Replace battery with a spare...
  • Page 115 Test/LPM Insertion: Instrumented: Data card is full. 1. Use an alternate TransMedics-supplied SD card. 2. Remove the SD card from the OCS™ Lung Console and delete files to create capacity. 3. At the end of the run, access trend graphs on the Wireless Monitor Data card 1.
  • Page 116 1. In the event of a software reset, the system will continue critical Please inform functions including ventilation, heating, pumping, and gas delivery TransMedics at the last settings made by the user. Note the error code displayed Customer in the Alarm Summary, acknowledge the alarm and proceed.

  • Page 117: Resetting The System

    • If the system appears to be inoperative or is not responding to commands • If a disabling system failure occurs • If instructed by TransMedics Service personnel If the system appears to be inoperative, setting the switch to Off and then On may restart the system and return it to the previous system status and previous settings for perfusate temperature, pump flow rate, ventilator mode, and gas flow.

  • Page 118: Shipping Equipment For Service

    Chapter 9: Troubleshooting 9.10. Shipping Equipment for Service In some situations, you may need to send equipment to TransMedics for service or replacement. For contact information, see Section 10.1, “Contacting TransMedics.” NOTE— Before returning equipment to TransMedics, please contact TransMedics Service regarding the return.

  • Page 119: Known Limitations Of The Ocs™ 3.1.2-C Software

    Known Limitations of the OCS™ 3.1.2-C Software The following table lists the known limitations that users of OCS™ Software 3.1.2-C may encounter and the steps TransMedics recommends to mitigate each situation. Table 9-14: Known Limitations of the OCS™ 3.1.2-C Software...

  • Page 120: Parts And Supplies

    Chapter 10: Parts and Supplies PARTS AND SUPPLIES This chapter lists the parts and supplies that you can order directly from TransMedics, Inc. 10.1. Contacting TransMedics Customer service representatives are available to answer questions and to provide maintenance and service.
  • Page 121 • • Clinical User Guide: OCS™ Lung System • Breathing Lung Transplant Training at TransMedics’ Andover MA (USA) Training and Development Facility • On-Call 24/7 Expert Run Support. A trained TransMedics clinical representative is available 24/7 for real-time telephone clinical support of in-process organ procurements.
  • Page 122 Chapter 10: Parts and Supplies Part Name Description Number • Integrated sensors (perfusate pressure, airway pressure, temperature) and communication circuitry Lung Instrumentation Tool Set Kitted sterile packaging contains: • Trachea connectors (3 sizes: .70 in (17.8 mm), .80 in (20.3 mm), .90 in (22.9 mm)) •...
  • Page 123 Chapter 10: Parts and Supplies Part Name Description Number 2461 Lung Monitoring (Quantity 2) Gas Cylinders These ultra-lightweight cylinders contain a gas mixture that has been optimized for lungs supported on the OCS™, when operating in Monitoring Mode. 2450 Lung Wireless A small monitoring system with an LCD screen and controls for configuring system functions Monitor and screen displays, and for adjusting system settings during use.

  • Page 124: Appendix A. Symbol Glossary

    Appendix A. Symbol Glossary APPENDIX A. SYMBOL GLOSSARY This glossary describes the symbols used on the packaging for the OCS ™ Lung System. Symbol Standard and Standard Title Symbol Definition Symbol Reference 21 CFR Labeling-Medical devices; prominence of Prescription only 801.15(c)(1)(i)F required label statements.
  • Page 125 Appendix A. Symbol Glossary Symbol Standard and Standard Title Symbol Definition Symbol Reference Proof of product compliance to North American safety standards, per Intertek IEC 60417-5140 Graphical symbols for use on equipment. Non-ionizing, electromagnetic radiation The weight of the OCS and perfusion module EN 50419 Marking of Electrical and Electronic...
  • Page 126 Appendix A. Symbol Glossary Symbol Standard and Standard Title Symbol Definition Symbol Reference Directive 93/42/EEC 765/2008/EC 768/2008/EC MDD CE marking indicates product 93/42/EEC Articles 4,11,12,17, Annex II) conformance with the applicable European Union Directives ISO 15223-1: 2012 Medical devices — Symbols to be used EC REP—Authorized Representative in with medical device labels, labelling and the European Community...
  • Page 127 Tel: +1 978 552 0900 Service: +1 978 552 0999 Fax: +1 978 552 0978 Website: www.transmedics.com Software Version 3.1.2 PN 100004070 Rev 6 REF 2103 © 2019 by TransMedics, Inc. All rights reserved. Printed in U.S.A. PN 100004070, REV 6 Page 127...

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