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Related Manuals for Organ recovery systems LifePort Kidney Transporter
Summary of Contents for Organ recovery systems LifePort Kidney Transporter
- Page 1 LifePort Kidney Transporter 1.1 Operator’s Manual...
- Page 2 Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands LifePort Kidney Transporter manufactured in the USA for Organ Recovery Systems, Inc. © 2020 Organ Recovery Systems, Inc. Made and printed in the USA. LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P...
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Page 3: Table Of Contents
Power Cord ..............................6 Data Cable ..............................6 Batteries ................................. 6 Safe Disposal of LifePort Kidney Transporter and LifePort Batteries ..............7 LifePort Kidney Transporter Disposable Products ....................7 LifePort Kidney Transporter Disposable Cannulas ..................7 LifePort Kidney Transporter Disposable Sterile Drape ................... 7 LifePort Kidney Transporter Disposable Perfusion Circuit ................ - Page 4 Clean Up and Review after Use ........................13 LifePort Kidney Transporter Use Introduction ................................14 Professional Overview ............................14 Maintain LifePort Kidney Transporter for Quick Response Use ................14 Prepare the Home Base Station ........................14 Prepare LifePort Kidney Transporter for Recovery ..................15 Travel with LifePort Kidney Transporter and Supplies ..................15 Fill LifePort Kidney Transporter Ice Container ....................15...
- Page 5 Storage ................................31 Repairs ................................31 Specifications, Precautions, Limitations Product Specifications ............................32 Device Classifications............................32 Electromagnetic Compatibility .......................... 33 Operational Precautions and Limitations ......................36 Hazards Overview................................38 Index ���������������������������������������������������������������������������������������������������������������������������� 39 755-00002 Rev P LifePort Kidney Transporter Operator’s Manual...
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Page 6: Purpose Of Manual
This manual provides the essential information necessary for installation, operation, and routine care of LifePort Kidney Transporter. The instructions within this manual should be carefully followed for safe and effective equipment use. It contains important operation and maintenance information for personnel trained to use this device. -
Page 7: Label Graphics Explanations
Label Graphics Explanations The following table provides an explanation of the label graphics found on LifePort Kidney Transporter. Warning/Caution Do Not Reuse Lot Number Do Not Resterilize STERILIZE STERILIZE Serial Number Temperature limits S S N N Reference Number Sterilized Using Aseptic Fill... -
Page 8: System Description
LifePort Kidney Transporter (LKT) is intended for use in continuous hypothermic machine perfusion of kidneys. Safety LifePort Kidney Transporter 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 (UL) and the International Electrotechnical Commission (IEC). -
Page 9: Ice Container
A molded thermoplastic Ice Container with a removable lid is designed to be filled with a recommended mixture of ice and water to provide a hypothermic temperature environment for the donor kidney. With the Ice Container properly loaded, LifePort Kidney Transporter preserves kidneys hypothermically to the same degree as conventional static storage methods, even when powered off. -
Page 10: Pump Deck
One is located upstream of the Perfusion Circuit Bubble Trap to divert detected bubbles away from the kidney and into the Wash Line, after which LifePort Kidney Transporter will resume perfusing. The other is located immediately before the Infuse Valve and prevents detected bubbles from entering the kidney by stopping perfusion altogether. -
Page 11: External Connections Panel
When powered on, LifePort Kidney Transporter draws power from one battery at a time, using the batteries in series. It is possible to operate LifePort Kidney Transporter with one to four batteries, as each battery delivers the 11 to 12 volts required. However, it is recommended to use all four batteries, keeping the batteries as fully charged as possible. -
Page 12: Safe Disposal Of Lifeport Kidney Transporter And Lifeport Batteries
LifePort Kidney Transporter will replenish the batteries whenever it is plugged into an external power supply. Plug in LifePort Kidney Transporter whenever not in transit to keep the batteries at the highest possible charge. It takes approximately five (5) hours to completely recharge all four (4) batteries. -
Page 13: Lifeport Kidney Transporter Disposable Perfusion Circuit
Pressure Sensor Connector Pump Tubing Loop Tubeframe Bubble Trap LifePort Kidney Transporter Disposable Perfusion Circuit contains the fluid management components necessary for perfusing a single kidney and is comprised of following: • Organ Cassette – The housing that contains the kidney and acts as the perfusate reservoir, where the kidney is maintained partially submerged. -
Page 14: Unpack, Setup, And Run Preliminary Tests Overview
24/7 Perfusion Helpline. Run Preliminary Tests Upon receipt of a new LifePort Kidney Transporter and prior to clinical use, it is recommended that the user complete the following tests. After each step, ensure LifePort Kidney Transporter functions as described and that there are no malfunctions, leaks or irresolvable errors. -
Page 15: Set Up Lifeport Kidney Transporter
NOTE: As a safeguard to the kidney, LifePort Kidney Transporter will not operate unless the Ice Container temperature is chilled below 8°C. After installation of the Ice Container, it may take several minutes before the display reads a temperature below 8°C. -
Page 16: Test Operating Modes
NOTE: The temperature reading may be high when first energized. When the Ice Container temperature is above 8°C, LifePort Kidney Transporter will not function and indicate an error message. It may take several minutes before the display reads below 8°C and the device is operational. -
Page 17: Test Batteries
13. Press and hold the POWER button to turn off LifePort Kidney Transporter. Test Batteries Upon receipt of a new LifePort Kidney Transporter and prior to clinical use, it is recommended that the user complete the Preliminary Tests with and without the batteries. Allow the batteries to charge in LifePort Kidney Transporter for at least five hours prior to clinical use. -
Page 18: Enter Device Information
3. Remove LifePort Kidney Transporter Disposable Perfusion Circuit and properly dispose of it. 4. Remove the Ice Container and empty its contents. 5. Dry and place the Ice Container back into LifePort Kidney Transporter. Leave the Ice Container Lid ajar. 6. Wipe down LifePort Kidney Transporter with a 70% isopropanol solution. -
Page 19: Lifeport Kidney Transporter Use Introduction
Use only ice and water to prevent freezing. Maintain LifePort Kidney Transporter for Quick Response Use Before you receive the call that LifePort Kidney Transporter is needed, keep it ready to go at a moment’s notice by performing the following procedures. -
Page 20: Prepare Lifeport Kidney Transporter For Recovery
Push the cart with LifePort Kidney Transporter and supplies to the vehicle and place the LifePort Kidney Transporter on the seat or in the trunk. • Secure LifePort Kidney Transporter from sliding or rolling. If the device is placed on a vehicle seat, the normal seat belt can be used to restrain it while driving. •... -
Page 21: Load Lifeport Kidney Transporter Disposable Perfusion Circuit
3. Using standard aseptic technique, remove the Kidney Cradle and set aside within the sterile field. 4. Using standard aseptic technique, fill LifePort Kidney Transporter Disposable Perfusion Circuit with 1 Liter chilled (2-8°C) perfusate. 5. Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid followed by the Outer Perfusion Circuit Lid. -
Page 22: Enter Organ Id Information
Right ureter Left adrenal gland Right adrenal gland Left renal artery Aorta Left kidney Right renal artery Right kidney Left renal vein Right renal vein Left ureter Inferior vena cava Right ureter LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P... -
Page 23: Cannulate The Kidney
Cannulate the Kidney LifePort Kidney Transporter Disposable Universal SealRing INDICATIONS FOR USE: The Universal SealRing is used when the vessel to be perfused ends with or without an aortic patch or similar condition. NOTE: The following procedure is performed on an aseptic field using standard aseptic technique. -
Page 24: Lifeport Kidney Transporter Disposable Straight Cannula
LifePort Kidney Transporter Disposable Straight Cannula INDICATIONS FOR USE: The Straight Cannula is used when the vessel to be perfused ends without a patch or when intimal damage to the lining is not a concern. NOTE: The following procedure is performed on an aseptic field using standard aseptic technique. -
Page 25: Place The Kidney
1. Using standard aseptic technique, carefully place LifePort Kidney Transporter Disposable Sterile Drape onto LifePort Kidney Transporter, lining up the drape gasket and the well of the Outer Perfusion Circuit Lid. 2. Using standard aseptic technique, ensure the arrow on the orientation guide is pointing toward the Pump Deck. -
Page 26: Prime And Initiate Perfusion
Once the Kidney Cradle containing the cannulated kidney has been placed into the LifePort Kidney Transporter Disposable Perfusion Circuit Organ Cassette in LifePort Kidney Transporter, it’s time to prime the Infuse Line to remove any bubbles from the line and renal artery. Once LifePort Kidney Transporter has finished priming, you can perfuse the kidney. -
Page 27: Data Station Monitoring
Message Explanations. The number to the left of the battery icon provides infuse time, telling how long LifePort Kidney Transporter has perfusing. The timer will start as soon as INFUSE has been pressed for the first time and will continue keeping track of the time when LifePort Kidney Transporter is in Infuse Mode. -
Page 28: Kidney Behavior On Lifeport Kidney Transporter
LifePort Kidney Transporter is capable of detecting certain situations during perfusion 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 setup to send these alerts via email or text message to any smartphone. -
Page 29: Traveling With Lifeport Kidney Transporter
Refill Ice / Swap Batteries LifePort Kidney Transporter is designed so the fully charged batteries and ice will last for 24 hours of operation with the Cover in place and latched. Monitor battery and ice levels during kidney preservation on LifePort Kidney Transporter. -
Page 30: Remove Kidney From Lifeport Kidney Transporter
3. Using standard aseptic technique, carefully place LifePort Kidney Transporter Disposable Sterile Drape onto LifePort Kidney Transporter, lining up the drape gasket and the well of the Outer Perfusion Circuit Lid. Ensure the arrow on the orientation guide is pointing toward the Pump Deck. -
Page 31: Data Capture And Download (Optional)
After downloading, the cases can be deleted from LifePort Kidney Transporter. Each LifePort Kidney Transporter data file can hold up to 48 hours of perfusion data. If a single perfusion case runs longer then 48 hours, a new file can be created only by cycling the power and resuming the perfusion. -
Page 32: Troubleshooting And Diagnostics
Troubleshooting and Diagnostics Most problems that you encounter in operating LifePort Kidney Transporter will be easily solved. The first thing to check when troubleshooting is to make sure that power is available from either the batteries or through the Power Cord plugged into a standard electrical outlet. If the power light comes on but LifePort Kidney Transporter still does not work, check the following guide. -
Page 33: Error Message Explanations
Many of these errors are self-correcting and perfusion will automatically resume. LifePort Kidney Transporter enters a fail-safe mode of static cold storage if any unrecoverable fault condition is encountered. Scroll through the Message Display Panel to view all of the fault conditions. The error indicators will remain viewable until cleared. - Page 34 Positioned Properly conditions. Connected Leaking Cannula or Artery Kidney Not Connected If problem is not resolved, call Organ Recovery Systems 24/7 Perfusion Helpline. 1. Check Tubeframe and Locking Arm position. 2. Check Pressure Sensor Cable connection. Load Perfusion The Tubeframe Not Properly...
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Page 35: Power On Self Test (Post)
Perfusion Helpline. Power On Self Test (POST) On each power up, LifePort Kidney Transporter performs a Power On Self Test or “POST”. The CPU within LifePort Kidney Transporter checks its memory functions, temperature sensors, Bubble Detectors, and its internal failure routines. In the unlikely event that one of these tests fail, LifePort Kidney Transporter will display “POST failure”... -
Page 36: Overview
Organ Recovery Systems 24/7 Perfusion Helpline. Storage If LifePort Kidney Transporter will not be used for several days or weeks, clean the device according to Clean Up After A Case before storing. LifePort Kidney Transporter should be stored indoors in a dry location out of direct sunlight. -
Page 37: 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 38: Electromagnetic Compatibility
Increase the distance between LifePort Kidney Transporter and receiver. • Connect LifePort Kidney Transporter to an outlet on a separate circuit from that to which the receiver is connected. Portable and mobile RF communications equipment can affect LifePort Kidney Transporter. - Page 39 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...
- Page 40 FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which LifePort Kidney Transporter is used, exceeds the applicable RF compliance level above, LifePort Kidney Transporter should be observed to verify normal operation.
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Page 41: 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 42 Air Transport—Prior to beginning air transport, make sure that ice and Battery levels are sufficient for entire transport duration. 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.
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Page 43: Hazards
USE ONLY IN SAFE ENVIRONMENTS. WARNING: Do not open LifePort Kidney Transporter to service it. Shock hazard exists if Pump Deck is removed. All aspects of LifePort Kidney Transporter that are meant to be attended by the Operator are accessible without opening the Device. -
Page 44: Index
Control Panel 3, 4, 9, 10 Isolate the Kidney Vascular Structure 17 LifePort Kidney Transporter Disposable Coupler 19 isopropanol solution 13 LifePort Kidney Transporter Cover 10, 13, 20, 24, 25, 26 CROSS CLAMP TIME 17 KIDNEY 11, 17 Kidney Cradle 8, 16, 20, 21, 25... - Page 45 Mesh Organ Restraint 8, 20, 25, 28 Message Display Panel 6, 11, 24, 28 Test Operating Modes 11 Travel with LifePort Kidney Transporter and Supplies Operational Accessories 6 Troubleshooting and Diagnostics 9, 11, 31 Operational Precautions and Limitations 1, 36...