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Organ recovery systems LifePort Kidney Transporter LKT100P Operator's Manual

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LifePort Kidney Transporter
Operator's Manual 1.0

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Summary of Contents for Organ recovery systems LifePort Kidney Transporter LKT100P

  • Page 1 LifePort Kidney Transporter Operator’s Manual 1.0...
  • Page 2 Perfusion Helpline: +1.866.682.4800 +32.2.715.0005 +55.11.98638.0086 www.organ-recovery.com www.patents-organrecoverysystems.com Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands T +31.70.345.8570 F +31.70.346.7299 service@emergogroup.com LifePort Kidney Transporter manufactured in the USA for Organ Recovery Systems. LifePort Kidney Transporter Operator’s Manual 755-00029 Rev H...
  • Page 3 Retain the following in your records: Institution___________________________________________________________________ Contact____________________________________________________________________ Model Number______________________________________________________________ Serial Number______________________________________________________________ Date of Purchase____________________________________________________________ 755-00029 Rev H LifePort Kidney Transporter Operator’s Manual...

  • Page 4: Table Of Contents

    Table of Contents How To Use This Manual Introduction………………………………………………………………………………………………………………7 Purpose of Manual………………………………………………………………………………………………………7 Abbreviations……………………………………………………………………………………………………………..8 System Description Intended Use……………………………………………………………………………………………………………    9 Safety…………………………………………………………………………………………………………………….9 Physical Description……………………………………………………………………………………………………    9 Main Enclosure…………………………………………………………………………………………………….10 Ice Container……………………………………………………………………………………………………….10 Pump Deck…………………………………………………………………………………………………………10 Electronics…………………………………………………………………………………………………………..11 Control Panel……………………………………………………………………………………………………….11 Outer Display……………………………………………………………………………………………………….12 LifePort Disposables…………………………………………………………………………………………………..12 LifePort Perfusion Circuit (Cassette)…………………………………………………………………………….12 LifePort Disposable Cannulas…………………………………………………………………………………….13 LifePort Sterile Drape………………………………………………………………………………………………13 Operational Accessories………………………………………………………………………………………………13...
  • Page 5 Using the LifePort Introduction……………………………………………………………………………………………………………..22 Professional Overview…………………………………………………………………………………………………22 Maintaining the LifePort for Quick Response Use………………………………………………………………….22 Preparing the Home Base Station………………………………………………………………………………..22 Preparing the LifePort for Recovery………………………………………………………………………………….23 Cooling Down the LifePort………………………………………………………………………………………....23 Traveling with the LifePort and Supplies………………………………………………………………………...24 Setting Up the Kidney Perfusion Circuit (Cassette)…………………………………………………………….24 Isolating the Kidney Vascular Structure……………………………………………………………………………...26 Cannulating the Kidney………………………………………………………………………………………………..27 Using the Straight Cannula………………………………………………………………………………………..27...
  • Page 6 Troubleshooting and Diagnostics Troubleshooting Procedures………………………………………………………………………………………….49 Error Message Explanations………………………………………………………………………………………….50 Power On Self Test (POST)…………………………………………………………………………………………..  5 3 Maintenance Overview………………………………………………………………………………………………………………...54 Cleaning Up after a Case……………………………………………………………………………………………..  5 4 Storage………………………………………………………………………………………………………………….54 Shipping by Common Carrier…………………………………………………………………………………………55 Specifications, Precautions, Limitations Product Specifications…………………………………………………………………………………………………55 Device Classifications………………………………………………………………………………………………….56 Electromagnetic Compatibility………………………………………………………………………………………...56 Operational Precautions and Limitations…………………………………………………………………………….60 Hazards Overview………………………………………………………………………………………………………………...62 LifePort Kidney Transporter Operator’s Manual...

  • Page 7: How To Use This Manual Introduction

    How To Use This Manual Introduction It is important that all personnel who will operate the LifePort Kidney Transporter (LifePort): • Read and understand this manual before operating the LifePort. Follow all warnings and precautions outlined in the sections Specifications, Precautions and •...

  • Page 8: Abbreviations

    Abbreviations The abbreviations used in this manual are listed and defined in the following table. Amperes Alternating current A-hr Ampere-hours °C Degrees Celsius Centimeter (1 cm = .01 m) Liter (1L =0.001 m3) lb(s) Pound (1 lb = 0.45 kg) Liquid Crystal Display Light Emitting Diode Kilogram (1 kg = 2.2 lbs)

  • Page 9: System Description

    System Description Intended Use The LifePort is intended for use in continuous hypothermic machine perfusion of kidneys. Safety The responsibility for safety when using LifePort resides within the healthcare professionals who use it. The LifePort is safe when used as described in this manual. It is designed to meet recognized U.S. and international standards for medical equipment and systems, as stated by the Underwriters Laboratories and the International Electro-technical Commission.

  • Page 10: Main Enclosure

    The LifePort is designed to integrate with the clinical environment by using readily available supplies, requiring minimal user intervention, and by being easy to use. Once the Ice Container is properly loaded, even when the LifePort is powered off, it preserves kidneys hypothermically to the same degree as conventional static (ice-pack) storage methods.

  • Page 11: Electronics

    • Pressure Sensor Cable — Provides the LifePort computer with information about the perfusion pressure felt by the kidney. If the Pressure Sensor connection is broken, the LifePort stops and displays an error message. • The Infuse and Wash Valves — Determine whether the perfusate enters (Infuse Valve) or bypasses (Wash Valve) the kidney.

  • Page 12: Outer Display

    Perfusion Circuit (Cassette). Each Disposable is factory pre-sterilized and delivered in an easy-to-open sterile pack. NOTE: To reorder Disposables, please contact Organ Recovery Systems. (See inside front cover for contact details.) The primary disposables are shown—separated for easier visualization—in the illustration below.

  • Page 13: Lifeport Disposable Cannulas

    Circuit (Cassette). Operational Accessories In operation, the LifePort uses special accessories and supplies. To work properly, it is important to use only accessories and supplies provided by Organ Recovery Systems or from vendors identified as compatible with the LifePort. Power Cord The LifePort comes equipped with a Power Cord (hospital grade), which can be connected to the LifePort back panel and to a standard grounded power outlet of commercial or hospital quality.

  • Page 14: Battery Charger (Optional)

    Battery Charger to charge them separately. This enables you to maintain a supply of spare charged batteries. The Battery Charger is available from Organ Recovery Systems. 1. Plug the Battery Charger into an external power supply.

  • Page 15: Label Graphics Explanations

    For safe disposal of your LifePort Kidney Transporter or the LifePort batteries (SM 201-6) you may return them to Organ Recovery Systems. You can call the Organ Recovery Systems Perfusion Helpline to arrange for pickup from your facility, or return them directly to Organ Recovery Systems.

  • Page 16: Unpacking, Setup, And Preliminary Testing Overview

    All items listed on the shipping documents are present. Report any damage found from this inspection to the carrier immediately. If you have any concerns about the condition of the LifePort or accessories, contact Organ Recovery Systems Perfusion Helpline. LifePort Kidney Transporter Operator’s Manual...

  • Page 17: Running Preliminary Tests

    Running Preliminary Tests Perform the following trial run with the LifePort to make sure that it is working properly. After each step, observe the system to make sure that it functions as described and that there are no malfunctions, leaks, or irresolvable errors.

  • Page 18: Energizing The Lifeport

    5. Close and latch the Pump Head Loop to clamp the tubing. 6. Rotate the Pump Deck Locking Arm 90° and snap into place. Step 7 Step 5 Step 6 7. Connect the Pressure Sensor Cable from the Pump Deck to the connector on the Tubeframe. 8.

  • Page 19: Testing Operating Modes

    Testing Operating Modes 1. Close and latch the Pump Head Loop to clamp the tubing. 2. Rotate the Pump Deck Locking Arm 90° and snap into place. 3. Connect the Pressure Sensor Cable from the Pump Deck to the connector on the Tubeframe. 4.

  • Page 20: Checking Duration Of Operation (Optional)

    Checking Duration of Operation (optional) 1. While unit is connected to an external power supply, press the SCROLL buttons on the Outer Display to observe battery data on the Message Display Panel. The batteries should display a range between 95% to 100% capacity. 2.

  • Page 21: Cleaning Up And Review After Use

    Problems uncovered during any of these tests should be investigated and resolved. Be aware to look for leaks, misrouted flow, and extra or missing error messages. The system should always stay dry and error-free. If you need assistance, contact Organ Recovery Systems Perfusion Helpline. 755-00029 Rev H LifePort Kidney Transporter Operator’s Manual...

  • Page 22: Using The Lifeport Introduction

    Check the labeling of the perfusion solution and make sure that it is intended for machine perfusion. If you are uncertain about which solutions are appropriate, contact Organ Recovery Systems Perfusion Helpline for information on recommended perfusates that work best in the LifePort.

  • Page 23: Preparing The Lifeport For Recovery

    Preparing the LifePort for Recovery You can modify these instructions according to your institution’s procedures. When you receive the call that the LifePort is needed, perform the following procedures to prep the device before taking it to receive a kidney. Make Sure You Have Everything You Need Using a checklist, double check all your equipment and supplies to make sure it is all packed and on the cart.

  • Page 24: Traveling With The Lifeport And Supplies

    Traveling with the LifePort and Supplies If you’re traveling with the LifePort, be sure to take the following precautions: if you are taking a vehicle, push the cart with LifePort and supplies to the vehicle, and place the LifePort on the seat or in the trunk. Secure the LifePort from sliding or rolling.
  • Page 25 5. Using aseptic technique, cover the Perfusion Circuit (Cassette) with the Inner Lid. 6. Using aseptic technique, cover the Perfusion Circuit (Cassette) with the Outer Lid. 7. Place the sealed Perfusion Circuit (Cassette) in the Ice Container. The Tubeframe must be perpendicular to the Pump Deck, and the hinges must be positioned inside of the receivers on the Pump Deck.

  • Page 26: Isolating The Kidney Vascular Structure

    NOTE: If the Outer Display reads: Power up test FAILED, reference the error number shown following in Troubleshooting and Diagnostics on page 49. Isolating the Kidney Vascular Structure Use the procedures specified by your institution for isolating the kidney vascular structure. The following suggestions will facilitate the preparation of kidneys for placement in LifePort disposable cannulas.

  • Page 27: Cannulating The Kidney

    1. Visually inspect the kidneys from a gross anatomy standpoint, paying close attention to the aorta, artery(s), vein(s), and ureter. 2. Direct a non-sterile assistant to note any anomalies into the perfusion record. NOTE: If a non-sterile assistant is not available, write the anomalies initially on the sterile table covers. Transfer the information to the perfusion record as soon as the procedure is finished.

  • Page 28: Using The Sealring Cannula

    Step 5 6. Adjust the height and rotation of the cannula. 7. Mount the cannula to comfortably position the vessel. 8. Visually inspect the vessel, ensuring there are no twists or occlusions. 9. Drape the Mesh Organ Restraint over the kidney and secure the organ in the Kidney Cradle. Step 9 Using the SealRing Cannula INDICATION: The SealRing cannula is used when the vessel to be perfused terminates with an aortic...
  • Page 29 3. Slide the aortic patch through the center of the cannula ring. 4. Lay the patch flat, making sure the tissue covers the entire sealing ring. If necessary, instruments may be used to temporarily hold the tissue in place until the cannula is secure. Step 4 Step 3 5.

  • Page 30: Using The Coupler

    Using the Coupler INDICATION: The Coupler is used to connect two or more SealRing or Straight cannulas when multiple vessels must be perfused. The example shown in the illustration is a kidney with isolated anatomical structures and aortic patch, but may also apply to any combination of vessel and cannula types. NOTE: Perform the following procedure on an aseptic field using aseptic technique.
  • Page 31 8. Identify a main vessel. 9. Place the organ in the Kidney Cradle and snap the cannula connected to the main vessel into the Cannula Mount. Step 9 10. Adjust the height and rotation of the Cannula Mount to position the vessel. 11.

  • Page 32: Using The Universal Sealring

    Using the Universal SealRing INDICATION: The Universal SealRing is designed for use when the vessel to be perfused terminates with or without an aortic patch or similar condition. The example shown in the illustration is a kidney with isolated anatomical structures and an irregular/incomplete aortic patch. Choose the size appropriate to the diameter of the vessel orifice.

  • Page 33: Placing The Kidney In The Lifeport

    7. Gravity-flow small amounts of flush solution into the cannula, then check for and repair any leaks that occurred in the surgical process or with the cannula. 8. Place the kidney in the Kidney Cradle and snap the cannula into the Cannula Mount. Step 8 9.
  • Page 34 3. A person outside the aseptic field, remove the Outer Lid from the Perfusion Circuit (Cassette). 4. Using aseptic technique, position the folded LifePort Sterile Drape (supplied) over the Perfusion Circuit (Cassette) as shown. Step 4 Step 3 5. Using aseptic technique, unfold the Sterile Drape along the length of the LifePort. 6.

  • Page 35: Priming The Infuse Line

    Priming the Infuse Line When the Kidney Cradle containing the kidney has been placed in the Perfusion Circuit (Cassette), use the following procedure to prime the Infuse Line, removing bubbles from the line and renal artery. This procedure is performed using aseptic technique. NOTE: For better clarity, the following illustrations of the Perfusion Circuit (Cassette) and Kidney Cradle with kidney will be shown outside the LifePort.

  • Page 36: Preliminary Testing For Leaks

    SealRing cannula, where the kidney attaches. 3. Check whether the perfusion fluid is leaking out of the Perfusion Circuit (Cassette). If so: • Contact Organ Recovery Systems Perfusion Helpline. We want the Perfusion Circuit (Cassette) returned so we can address the problem. •...

  • Page 37: Initiating Perfusion

    Initiating Perfusion 1. Viewing through the Sterile Drape, press the UP/DOWN arrow button to choose the pumping pressure. NOTE: The default setting is 30 mmHg. 2. Having resolved any preliminary issues with leaks, press the INFUSE button to start the infusion process.

  • Page 38: Vein Positioned On Top

    Most of these will already be tied off but others may reveal themselves once perfusion begins. Tie them off or clamp them as best you can. We are aware there can be problems. Depending on conditions: • You may not be physically able to identify the leaking vessels. •...

  • Page 39: Monitoring Options For A Kidney On The Lifeport

    2. Remove the Sterile Drape. 3. According to hospital protocol, mark identification information on the Perfusion Circuit (Cassette) as indicated. CAUTION: Avoid marking identification on the Outer Lid. Identification on the Tubeframe is preferred. 4. A person outside the aseptic field, carefully place the Outer Lid on the Perfusion Circuit (Cassette). 5.
  • Page 40 • Pressure — this is the actual systolic pressure of the perfusion process, as the LifePort attempts to achieve the pressure you have set. This value is often lower but should never be higher than the selected pressure. Flow — the flow changes, depending on how the kidney is responding to the pumping. This value is •...

  • Page 41: Data Station Monitoring

    • Data memory remaining — from the point when the INFUSE button was pressed, the LifePort creates and stores a data file of 48 hours in length, useful in creating a record of the case. This clock counts down from 48 hours, telling how much memory time remains. NOTE: The unit can create five of these files, covering five procedures.

  • Page 42: Typical Behavior Of A Kidney On Lifeport

    Typical Behavior of a Kidney on LifePort The graphs below — excerpted from the 2nd page of a Data Station case report — show four parameters of the typical behavior of a kidney on the LifePort: Pressure, Flow, Resistance, and Temperature. It is normal to see flow increase while resistance decreases.

  • Page 43: Nonresponding Kidney

    Nonresponding Kidney A nonresponding kidney — not responding to mechanical perfusion — typically shows some degree of flow, however no concurrent decrease in resistance. In this case, it may be appropriate to review avail- able donor, kidney, procurement, and recipient data before making any decision. Flow (ml/min) Resistance (mmHg/ml/min) Remote Monitoring...

  • Page 44: Adding More Ice

    NOTE: The LifePort will alert when the batteries have two hours remaining or when the temperature in the Ice Container reaches 8°C. However, make a habit of checking temperature and battery level. Adding More Ice Check the temperature on the Outer Display to make sure that it is steady and below 8°C. •...

  • Page 45: Removing The Kidney From The Lifeport For Transplant

    Removing the Kidney from the LifePort for Transplant There are several procedures for removing the kidney from the LifePort when the transplant surgeon is ready for the kidney. Two are detailed below. NOTE: These procedures can be modified as necessary. 1.
  • Page 46 Option A: 1. Press the STOP button to stop the infusion Pump. 2. Using aseptic technique, unscrew or cut the Pump Hose. 3. Using aseptic technique, carry the Kidney Cradle to the sterile field. 4. Using aseptic technique, unhook the Mesh Organ Restraint. 5.
  • Page 47 4. Using aseptic technique, lift the Kidney Cradle containing the kidney from the Perfusion Circuit (Cassette), and place in the bowl/basin for transfer to back table. 5. Carry the bowl/basin to back table or to recipient table to remove Mesh Organ Restraint and cannula Continue for both Option A and Option B: 6.

  • Page 48: Downloading Operational Data (Optional)

    IEC60601-1. Any person who connects additional equipment to the Data Port configures a medical system, and is therefore responsible for ensuring that the system complies with the system standard IEC60601-1. If in doubt, consult Organ Recovery Systems Perfusion Helpline. LifePort Kidney Transporter Operator’s Manual...

  • Page 49: Troubleshooting And Diagnostics

    Follow the instructions in the Error Messages Explanation LifePort. section on page 50. Missing or incorrect display Failure of displays or internal Call the Organ Recovery Systems elements at power-on computer Perfusion Helpline. Loose fitting or defective Perfusion 1. Retighten all fittings.

  • Page 50: Error Message Explanations

    1. Operate LifePort connected to an ???? in external power supply. Computer has lost communication with batteries battery status 2. Call the Organ Recovery Systems Perfusion Helpline. System becomes unable Air is persisting in Check Perfusion Circuit (Cassette) for Bubbles...
  • Page 51 Plug into mains power 3. If problem persists, note the POST failure message in the Display Screen and call the Organ Recovery Systems Perfusion Helpline. See list of POST test errors at the end of this section. Call the Organ Recovery Systems Pump Error Pump is not responding normally.
  • Page 52 System becomes unable disconnected. Connect to interact with pressure Sensor The LifePort is unable sensor properly. Call the Organ Recovery Systems Push to set the overpressure Perfusion Helpline. STOP alert setpoint 1. Press STOP to clear alert and enter Stop Mode.

  • Page 53: Power On Self Test (Post)

    POST error message as shown in the table below. Should one of these errors occur, remove all power to the LifePort by reinstalling the batteries and the mains Power Cord. If the POST message continues to display, call the Organ Recovery Systems Perfusion Helpline. POST Error Message...

  • Page 54: Maintenance Overview

    Maintenance Overview The LifePort has no user serviceable parts. Maintain, clean, and keep the LifePort ready to use according to directions in this manual. If the LifePort is not functioning properly refer to Troubleshooting and Diagnostics on page 49 or contact Organ Recovery Systems Perfusion Helpline.

  • Page 55: Shipping By Common Carrier

    — either the original carton or the carton containing the loaner — as provided by Organ Recovery Systems. Follow instructions for packing that were provided with the loaner, or contact Organ Recovery Systems Perfusion Helpline for instructions. Make sure the Ice Container is empty, with the Lid removed for shipment.

  • Page 56: Device Classifications

    Data Cable Part # 20680 Power Cord Part # 17664 (US only, contact Organ Recovery Systems for international power cord part numbers) WARNING: Use of power cords or communications cables, other than those specified, may result in increased emissions or decreased immunity of the LifePort.
  • Page 57 Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC EMISSIONS The LifePort is intended for use in the electromagnetic environment specified below. The customer or the user of the LifePort should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment: Guidance The LifePort uses RF energy only...
  • Page 58 Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC IMMUNITY The LifePort is intended for use in the electromagnetic environment specified below. The customer or the user of the LifePort should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 test level Compliance level Environment: Guidance...
  • Page 59 Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC IMMUNITY The LifePort is intended for use in the electromagnetic environment specified below. The customer or the user of the LifePort should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 test level Compliance level Environment: Guidance...

  • Page 60: Operational Precautions And Limitations

    Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the LifePort The LifePort is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LifePort can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LifePort as recommended below, according to the maximum output power of the communications equipment.
  • Page 61 Do not connect the LifePort to an external electrical power source on a commercial aircraft. Do not connect the Data Cable to the LifePort during flight on a commercial aircraft. CAUTION: All LifePort users should be familiar with Organ Recovery Systems kidney perfusion solution (KPS-1 ®...

  • Page 62: Hazards Overview

    LifePort that are meant to be attended by the operator are accessible without opening the device. If there is a service problem, please call the Organ Recovery Systems Perfusion Helpline. WARNING: Beware of rotating parts. Keep hands, clothing, jewelry, ID lanyards, etc. away from the vicinity of the Infusion Pump when the LifePort is turned on.
  • Page 63 Index Compliance Chamber, 13 ????in battery status (Error Message), 50 Connections, external, 11 Abbreviations, 8 Control Panel, 9, 10, 11, 15, 16, 18, 26 AC Plug (Connection), 11 Coolant Source, 55 Adding More Ice, 44 Cooling Down the LifePort, 23 After a Case, 54 Coupler, 12, 30, 31, 35, 38 Backlight, 41...
  • Page 64 High Resistance (Error Message), 51 Occlusion (Error Message), 51 Operating Home Base Station Conditions, 55 Preparing, 23 Selecting, 16 Modes, Testing, 19 Operational Hypothermia, maintaining, 44 Data, downloading, 48 Ice Container Filling, 17 Outer Display, 12 Ice, adding more, 44 Overview, Professional, 23 Perfsuion Circuit (Cassette), 9, 17, 19 Indications for Use, 55...
  • Page 65 Replacing Batteries, 44 Return Line, 13 Rotating Parts Hazard, 62 Safety Features, 9 Safety Latch, 9 Sample Port, 13 Scroll Buttons (Outer Display), 12 SealRing Cannula, 28 Sensor Error (Error Message), 52 Setpoint Error (Error Message), 52 Setting up the Kidney Perfusion Circuit (Cassette), 24 Shipping by Common Carrier, 55 Shock Hazard, 62 Specifications, Precautions, Limitations, 60...

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