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Organ recovery systems LifePort Kidney Transporter LKT101P Operator's Manual

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LifePort Kidney Transporter
Operator's Manual 1.1

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Summary of Contents for Organ recovery systems LifePort Kidney Transporter LKT101P

  • Page 1 LifePort Kidney Transporter Operator’s Manual 1.1...
  • Page 2 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. ©2018 Organ Recovery Systems, Inc. 10/2018 Made and printed in the USA. LifePort Kidney Transporter Operator’s Manual 755-00002 Rev K...
  • Page 3 Retain the following in your records: Institution___________________________________________________________________ Contact____________________________________________________________________ Model Number______________________________________________________________ Serial Number______________________________________________________________ Date of Purchase____________________________________________________________ 755-00002 Rev K 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 External Communications………………………………………………………………………………...11 Circuit Breaker……………………………………………………………………………………………..11 Control Panel………………………………………………………………………………………………………11 Outer Display………………………………………………………………………………………………………12 LifePort Kidney Transporter Disposables………………………………………………………………………12 LifePort Kidney Transporter Disposable Kidney Perfusion Circuit....………………………13 LifePort Kidney Transporter Disposable Kidney Cannulas…………………………………………...13 LifePort Kidney Transporter Disposable Kidney Sterile Drape……………………………………….13...
  • Page 5 Testing the Batteries ………………………………………………………………………………………………….. 20 Checking Duration of Operation (Optional)…………………………………………………………………………20 Entering Device Information………………………………………………………………………………………….20 External Communications using Data Station………………………………………………………………………20 GPS/GPRS Tracking Capability……………………………………………………………………………………...21 Cleaning Up and Review after Use   … ………………………………………………………………………………21 Using LifePort Kidney Transporter Introduction…………………………………………………………………………………………………………….22 Professional Overview………………………………………………………………………………………………..22 Maintaining LifePort Kidney Transporter for Quick Response Use………………………………………………22 Preparing the Home Base Station……………………………………………………………………………….22 Preparing LifePort Kidney Transporter for Recovery………………………………………………………………23 Cooling Down LifePort Kidney Transporter……………………………………………………………………..23...
  • Page 6 Delivering to the Transplant OR……………………………………………………………………………………..  4 4 Checking Battery Power and Ice………………………………………………………………………………..  4 4 Adding More Ice………………………………………………………………………………………………..44 Replacing Batteries……………………………………………………………………………………………..44 At the Transplant OR  … …………………………………………………………………………………………...45 Waiting until Recipient Surgery Is Ready.……………………………………………………………………….45 Removing the Kidney from LifePort Kidney Transporter for Transplant.…………………………………….45 Capturing and Downloading Data (Optional)……………………………………………………………………48 Introduction………………………………………………………………………………………………….48 To Flash Drive……………………………………………………………………………………………….49...

  • Page 7: How To Use This Manual Introduction

    LifePort Kidney Transporter is intended to be used for the hypothermic machine perfusion of kidneys. If more information is needed about installation, organ perfusion or if you have any questions, please contact the Organ Recovery Systems Perfusion Helpline. Purpose of Manual The instructions within this manual should be carefully followed for safe, trouble-free and effective equipment use.

  • 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 Intended Use

    System Description Intended Use LifePort Kidney Transporter is intended for use in continuous hypothermic machine perfusion of kidneys. Safety The responsibility for safety when using LifePort Kidney Transporter resides within the healthcare professionals who use it. LifePort Kidney Transporter is safe when used as described in this manual. It is designed to meet recognized U.S.

  • Page 10: Main Enclosure

    LifePort Kidney Transporter 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 LifePort Kidney Transporter 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 LifePort Kidney Transporter computer with information about the perfusion pressure felt by the kidney. If the Pressure Sensor connection is broken, LifePort Kidney Transporter 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

    Outer Display The Outer Display—a horizontal panel visible whether the Cover is in place or removed—provides information on operational parameters as well as additional information about the perfusion history. MESSAGE DISPLAY PANEL shows ORGAN ID, Kidney Side, Blood Type, Unit ID, VASCULAR 0peration Mode, Pump Time SYSTOLIC AND DIASTOLIC...

  • Page 13: Lifeport Kidney Transporter Disposable Kidney Perfusion Circuit

    Operational Accessories In operation, LifePort Kidney Transporter 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 LifePort Kidney Transporter. Power Cord LifePort Kidney Transporter comes equipped with a Power Cord (hospital grade), which can be connected to LifePort Kidney Transporter’s back panel and to a standard grounded power outlet of...

  • Page 14: Batteries

    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: Perfusion Mode

    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. See Information on page 2. 755-00002 Rev K...

  • 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 LifePort Kidney Transporter or Accessories, contact the Organ Recovery Systems Perfusion Helpline.

  • Page 17: Setting Up The Lifeport Kidney Transporter

    Setting Up LifePort Kidney Transporter CAUTION: LifePort Kidney Transporter weighs 45 lbs (20.4 kg) fully loaded. Use proper lifting procedures to avoid injury. 1. Holding the handles, lift LifePort Kidney Transporter and place on its home base station table or countertop so that the Outer Display is easily accessible and facing you.

  • Page 18: Energizing Lifeport Kidney Trasporter

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

  • Page 19: Wash

    Wash 1. Press the WASH button and verify pump rotation. 2. Verify that perfusate is drawn from the Perfusion Circuit, into the Pump and then down into the filter. NOTE: Within a couple of minutes, perfusate should flow out of the filter, into the Bubble Trap, then into the wash port of the Perfusion Circuit.

  • Page 20: Testing The Batteries

    Testing the Batteries 1. OpenLifePort Kidney Transporter Battery Door by sliding it away from the product label. 2. Insert the batteries. 3. Replace the LifePort Kidney Transporter Battery Door. NOTE: LifePort Kidney Transporter Battery Door should be in place whenever LifePort Kidney Transporter is operated or transported.

  • Page 21: Gps/Gprs Tracking Capability

    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 the Organ Recovery Systems Perfusion Helpline. 755-00002 Rev K LifePort Kidney Transporter Operator’s Manual...

  • Page 22: 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 the Organ Recovery Systems Perfusion Helpline for information on recommended perfusates that work best in LifePort Kidney Transporter.

  • Page 23: Preparing Lifeport Kidney Transporter For Recovery

    Preparing LifePort Kidney Transporter for Recovery You can modify these instructions according to your institution’s procedures. When you receive the call that LifePort Kidney Transporter 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: Setting Up The Disposable Kidney Perfusion Circuit

    LifePort Kidney Transporter can withstand the normal handling involved in traveling between hospitals; however, it should be kept in an upright orientation to minimize the potential for leaks, spills or air bubbles. If LifePort Kidney Transporter is transported in a vehicle seat, the normal seatbelt can be used to restrain LifePort Kidney Transporter while driving.
  • Page 25 5. Using aseptic technique, cover the Perfusion Circuit with the Inner Lid. 6. Using aseptic technique, cover the Perfusion Circuit with the Outer Lid. 7. Place the sealed Perfusion Circuit 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 16. Close and latch the Cover. Step 15 Step 16 NOTE: If the Outer Display panel shows an error, reference the error number shown following in Troubleshooting and Diagnostics on page 50. LifePort Kidney Transporter Operator’s Manual 755-00002 Rev K...

  • Page 27: Isolating The Kidney Vascular Structure

    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 Kidney Transporter Disposable Kidney cannulas. Left Inferior adrenal gland vena cava Right Aorta...

  • Page 28: Cannulating The Kidney

    If the artery has any type of occlusion, determine whether the plaque will break off and • block the artery or if cannulation will cause damage to the artery. • If you determine that cannulation will be safe, proceed to cannulation. Cannulating the Kidney Using LifePort Kidney Transporter Disposable Kidney SealRing cannula INDICATIONS FOR USE: The SealRing cannula is used when the vessel to be perfused terminates with...

  • Page 29: Using The Disposable Kidney Straight Cannula

    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 30: Using The Disposable Kidney Coupler

    3. Secure the vessel in place using silk ties, vessel loops or another appropriate material. A groove in the tip is provided for positioning and securing. Step 3 4. 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.
  • Page 31 3. Slide aortic patches through the center of each cannula ring. 4. Lay each 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 3 Step 4 5.

  • Page 32: Using The Disposable Kidney Universal Sealring Cannula

    13. Replace the End Cap of the main cannula with one end of the Coupler. Step 13 Coupler 14. Attach the second end of the Coupler to the Infuse Port of the next cannula. Using LifePort Kidney Transporter Disposable Kidney Universal SealRing INDICATIONS FOR USE: The Universal SealRing is designed for use when the vessel to be perfused terminates with or without an aortic patch or similar condition.
  • Page 33 4. Lower the upper portion of the cannula carefully bringing the conical seal into the interior of the vessel. Viewing through the magnified sight-glass, verify that the vessel orifice is centered, circular in shape and not occluded. Wrap each strap, straight and securely, around both cannula halves and fix the straps to their posts.

  • Page 34: Placing The Kidney In Lifeport Kidney Transporter

    Placing the Kidney in LifePort Kidney Transporter BEFORE YOU BEGIN: Make sure you have prepared LifePort Kidney Transporter following instructions provided in the Professional Overview on page 22. 1. A person outside the aseptic field, remove the LifePort Kidney Transporter Cover. 2.

  • Page 35: Placing The Kidney

    15. Use the arrow buttons to enter the correct cross clamp time zone. NOTE: The time zone must be in 3 characters, e.g., “CST” for “Central Standard Time”. 16. Click OK, then select SAVE to confirm. 17. Use the arrow buttons to select DATE, then press OK. 18.

  • Page 36: Priming The Infuse Line

    7. Using aseptic technique, place the Kidney Cradle in the Perfusion Circuit. Step 7 Priming the Infuse Line When the Kidney Cradle containing the kidney has been placed in the Perfusion Circuit, 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 and Kidney Cradle with kidney will be shown outside LifePort Kidney Transporter.

  • Page 37: Preliminary Testing For Leaks

    SealRing cannula, where the kidney attaches. 3. Check whether the perfusion fluid is leaking out of the Perfusion Circuit. If so: • Contact Organ Recovery Systems Perfusion Helpline. Retain the potentially defective Perfusion Circuit and return to Organ Recovery Systems. • Replace the Perfusion Circuit.

  • Page 38: Initiating Perfusion

    Initiating Perfusion 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 39: Side Branches Closed

    Side Branches Closed? There may be small branches coming off of the main renal artery that go to other arteries that have been snipped off during the recovery process. If these have not been effectively tied off, perfusate can leak from them during perfusion.

  • Page 40: Closing Lifeport Kidney Transporter

    Closing LifePort Kidney Transporter Having completed the visual inspection, close LifePort Kidney Transporter. Step 1 1. Replace the Inner Lid over the Perfusion Circuit. 2. Remove the Sterile Drape. 3. According to hospital protocol, mark identification information on the Perfusion Circuit as indicated. CAUTION: Avoid marking identification on the Outer Lid.

  • Page 41: Monitoring Via Lifeport Kidney Transporter Outer Display

    Monitoring Via LifePort Kidney Transporter Outer Display The LifePort Kidney Transporter Outer Display provides comprehensive information on the status of the pumping procedure during perfusion, providing the following information: PRESSURE FLOW RESISTANCE TEMPERATURE 30/18 0.18 5.0° 2.3° ml/min mmHg/ml/min Trap mmHg •...

  • Page 42: Data Station Monitoring

    NOTE: LifePort Kidney Transporter will create a data file that starts when you press the INFUSE button. The unit will store up to five files in memory. When five files are in memory, the unit will prompt you to delete the oldest file(s) before it will allow a new procedure to begin. Therefore, it is advisable to download the data from a procedure when it is completed and then to delete the file from LifePort Kidney Transporter.

  • Page 43: Typical Behavior Of A Kidney On Lifeport Kidney Transporter

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

  • Page 44: Remote Monitoring

    Remote Monitoring LifePort Kidney Transporter has the capability of detecting certain situations with the kidney and providing a physical and audible alert on such events. When LifePort Kidney Transporter is connected to a network computer, the Data Station software can be set up to send these alerts via email or text message to any smartphone.

  • Page 45: Replacing Batteries

    Replacing Batteries Check the battery level on the Message Display. Whenever LifePort Kidney Transporter is not in transit, plug LifePort Kidney Transporterinto an external power supply so the batteries are maintained in a charged condition. • If the batteries are running low, plug LifePort Kidney Transporter into an external power supply if possible.
  • Page 46 3. Using aseptic technique, position a folded LifePort Sterile Drape over the Perfusion Circuit as shown. 4. Using aseptic technique, unfold the Sterile Drape along the length of LifePort Kidney Transporter . Step 3 Step 4 5. Using aseptic technique, fully unfold the Sterile Drape, side-to-side. 6.
  • Page 47 Option B: 1. Using aseptic technique, unscrew the Pump Hose and direct the Infuse Line into a stainless steel bowl/basin. 2. Press the PRIME button to flow cold perfusate into the bowl. Option A continued: 3. When enough perfusate has been transferred, press the STOP button to stop the flow. 4.

  • Page 48: Capturing And Downloading Data (Optional)

    Continue for both Option A and Option B: 6. Using aseptic technique, unstrap, open and remove the clamp/cannula. 7. Using aseptic technique, perform the pre-transplant preparation on the kidney. 8. Once the kidney has been removed from the Transporter, remove the drape, replace the Perfusion Circuit Lids and Outer Cover on the LifePort, power off the device and prepare it for return to the home base station.

  • Page 49: To Flash Drive

    IEC60601-1-Sec. 16. 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-Sec. 16. If in doubt, consult the Organ Recovery Systems Perfusion Helpline. To Flash Drive If a computer is not readily available for evaluating the data file, you can download the file onto a flash drive, then later evaluate the data in a computer when one is available.

  • Page 50: Troubleshooting And Diagnostics

    Beeping or flashing LEDs Error Message Explanation LifePort Kidney Transporter. section on page 51. Missing or incorrect display Failure of displays or internal Call Organ Recovery Systems elements at power-on computer Perfusion Helpline. 1. Retighten all fittings. Loose fitting or defective Perfusion Leaking perfusate 2.

  • Page 51: Error Message Explanations

    1. Remove obstruction from filter Check tubing. Filter may be clogged. Filter 2. Call Organ Recovery Systems Perfusion Helpline. A pressure greater Inspect pressure sensor and call than 120% of the set Organ Recovery Systems Perfusion System is sensing pressure is persisting.
  • Page 52 Plug into external power supply or Battery infusion plus 2 hours of temperature monitoring. exchange for charged batteries. Motor Call the Organ Recovery Systems Current Pump not responding normally Perfusion Helpline. Failure Use ice slush made from ice and water Incorrect coolant only.
  • Page 53 Pressure System becomes unable The pressure sensor 1. Reconnect pressure sensor. Sensor to interact with pressure has become 2. Call Organ Recovery Systems Failure sensor properly. disconnected. Perfusion Helpline. 1. Press STOP to clear alert and enter Stop Mode. Pressure 2.

  • Page 54: Power On Self Test (Post)

    Should one of these errors occur, remove all power to LifePort Kidney Transporter 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 55: Maintenance

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

  • Page 56: Specifications, Precautions, Limitations

    Specifications, Precautions, Limitations Product Specifications Portable, self-contained renal preservation system, which Description utilizes hypothermic perfusion. LifePort Kidney Transporter is intended to be used for the continuous hypothermic machine perfusion of kidneys for the Indications for Use preservation, optional transportation and eventual transplantation into a recipient.

  • Page 57: Device Classifications

    Portable and mobile RF communications equipment can affect LifePort Kidney Transporter. WARNING: To assure compliance with EMC requirements, use only manufacturer-supplied cables, as shown below. If you have questions, contact the Organ Recovery Systems Perfusion Helpline. Data Cable Part # AK67222...
  • Page 58 Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC EMISSIONS LifePort Kidney Transporter 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...
  • Page 59 Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC IMMUNITY LifePort Kidney Transporter is intended for use in the electromagnetic environment specified below. The customer or the user of LifePort Kidney Transporter should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 test level Compliance level...

  • Page 60: Operational Precautions And Limitations

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

  • Page 62: Hazards

    (20.4 kg). Use proper lifting practices to avoid injury. CAUTION: Local regulations must be followed for the disposal of LifePort Kidney Transporter and lithium-ion Batteries. If in doubt, call the Organ Recovery Systems Perfusion Helpline. CAUTION: Use only grounded electrical connections. Connect LifePort Kidney Transporter to a grounded electrical outlet rated for voltage and amperage according to the labeled ratings on the product back panel.
  • Page 63 Index Port (Connection), 11, 14 Abbreviations, 8 Description, 9, 56 AC Plug (Connection), 11 Diagnostics, 50 Adding More Ice, 44 Dimensions, 56 Arriving at the Transplant OR, 45 Display Batteries Outer, 12 Charger, 14, 16 Disposables, LifePort, 10, 12 Disposal, 15 Downloading Door, 14, 20 Capturing Data, 48...
  • Page 64 Intended Use, 9 Power on Self Test (POST) Failure (Error Message), 52 Isolating the Kidney Vascular Structure, 27 Preliminary Tests, Running, 16 Kidney Preparing Cannulating, 28 Home Base Station, 22 Monitoring, 45 To Travel to the Transplant Site, 44 Placing in the LifePort, 34 LifePort for Recovery, 23 Vascular Structure, Isolating, 27 Pressure...
  • Page 65 Typical Behavior of a Kidney on LifePort, 43 Universal Precautions, Use of, 55 Universal SealRing Cannula, 32 Unpacking, Setup and Preliminary Testing, 16 Unresponsive, buttons (Trouble), 50 Use, Intended, 9 Valve Infuse, 11 Wash, 11 Vein Position, 39 Waiting until Recipient Surgery Is Ready, 45 Wash Button, 11 Line, 10...

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