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755-00002 Rev R   

 

           

  LifePort Kidney Transporter Operator’s Manual

10

Set Up LifePort Kidney Transporter

CAUTION: 

LifePort Kidney Transporter weighs 45 lbs (20.4 kg) fully loaded. Use proper lifting 

procedures to avoid injury.

1.  Place LifePort Kidney Transporter so that the Outer Display is easily accessible. 

2.  Unlatch and remove LifePort Kidney Transporter Cover and store it nearby. 

3.  Complete your review of LifePort Kidney Transporter, ensuring it is secure, intact, and that nothing 

appears damaged, before starting the preliminary tests.

Fill the Ice Container

NOTE:

 

USE ONLY ICE AND COLD WATER

 in LifePort Kidney Transporter Ice Container. A mixture of ice 

and cold water in the Ice Container will ensure that temperatures remain within the appropriate range for 

clinical kidney preservation.

1.  Open the 

Ice Container and fill with 

crushed or pelletized ice, pushing the ice as far in as possible.

2.  Pour approximately 1 Liter of cold water (less than 10°C) into the Ice Container, which will gradually 

loosen the ice.

3.  Add more ice and another 0.5–1.0 Liter of cold water until the Ice Container is full, maximizing the 

amount of ice added.

4.  Replace and lock the Ice Container Lid.

Load LifePort Kidney Transporter Disposable Perfusion Circuit

NOTE:

 As this is a preliminary test, aseptic technique does not have to be followed. For detailed, sterile 

instructions, refer to LifePort Kidney Transporter Disposable Perfusion Circuit Instructions For Use. 

 

1.  Ensure Locking Arms and Pumphead Raceway are open on LifePort Kidney Transporter. 

2.  Unpack LifePort Kidney Transporter Disposable Perfusion Circuit and place into the Ice Container.

3.  Position the Tubeframe upright, perpendicular to the Pump Deck. Insert the hinges into the receivers 

before rotating the 

Tubeframe flat onto the 

Pump Deck.

4.  Stretch the Pump Tubing Loop around the Infusion Pump. Close and latch the Pumphead Raceway.

5.  Rotate the Pump Deck Locking Arm 90 degrees until it clicks into place.

6.  Connect the Pressure Sensor Cable from the Pump Deck to the Pressure Sensor Connector on the 

Tubeframe.

7.  Remove the Inner and Outer Perfusion Circuit Lids and pour 1 Liter of cold (less than 10°C) water into 

the LifePort Kidney Transporter Disposable Perfusion Circuit. 

8.  Replace and secure the Inner and Outer Perfusion Circuit Lids.

Energize the LifePort Kidney Transporter

1.  Connect the Power Cord to LifePort Kidney Transporter External Connections Panel and plug it into an AC 

mains electrical outlet. 

2.  Press and hold the 

POWER

 button until you hear an audible beep, then release.

3.  On the Control Panel, you should observe the following:

•  The screens illuminate.

•  The pressure setpoint shows default value of 30 mmHg.

•  Mode control displays show 

WASH

PRIME

, and 

INFUSE

.

Summary of Contents for Kidney Transporter 1.1

Page 1: ...LifePort Kidney Transporter 1 1 Operator s Manual...

Page 2: ...Recovery Systems Inc 2460 Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands EC EC REP REP Aurora BioScience Pty Ltd Unit 4 22 Lexington Drive Bella Vista NSW 2153 Australia AUSTRALIA...

Page 3: ...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 Tran...

Page 4: ...ar Structure 17 Cannulate the Kidney 18 Place the Kidney 18 Place the Kidney in Kidney Cradle 18 Place the Kidney Cradle in LifePort Kidney Transporter 18 Prime and Initiate Perfusion 19 Check Kidney...

Page 5: ...00002 Rev R LifePort Kidney Transporter Operator s Manual iv Specifications Precautions Limitations Product Specifications 31 Device Classifications 31 Electromagnetic Compatibility 32 Hazards Overvie...

Page 6: ...ion for servicing internal components of LifePort Kidney Transporter If more information is needed about installation organ perfusion or if you have any questions please contact the Organ Recovery Sys...

Page 7: ...cture YYYY MM DD Keep Dry Keep Away From Sunlight Electric Shock Hazard Prescription Medical Device IPX1 Protected against falling water Power button standby power Circuit breaker Push to reset Data P...

Page 8: ...ols are provided and identified depending on the mode of operation and options available Acceptable operating ranges are established within LifePort Kidney Transporter for pressure temperature flow ra...

Page 9: ...t select and enter information SELECT MODE Wash Prime Infuse Organ ID ABC123 Kidney Blood Type Clamp Date Clamp Time Clamp TMZ N A N A 00 00 0 00 00 SET 30 mmHg Wash Prime Infuse Outer Display The Out...

Page 10: ...nformation about the perfusion pressure felt by the kidney If the Pressure Sensor connection is broken LifePort Kidney Transporter stops and displays an error message Bubble Detectors check the perfus...

Page 11: ...rter External Connections Panel and to a standard grounded power outlet of commercial or hospital quality Do not substitute an alternate Power Cord CAUTION Do not substitute the Power Cord Use only th...

Page 12: ...sal of LifePort Kidney Transporter and LifePort Batteries Lithium ion batteries must be disposed of according to local regulations For safe disposal of LifePort Kidney Transporter or LifePort Kidney T...

Page 13: ...and transparent Outer Lid provide a redundant watertight seal Kidney Cradle supports the kidney Mesh Organ Restraint holds the kidney in place in the Kidney Cradle Cannula Mount adjustable mount on t...

Page 14: ...or perfusate and other medications Tabletop space for a computer with USB port recommended Storage space for transplant coordinator gear cart bags procedure kits and coolers Proximity to operating roo...

Page 15: ...liminary test aseptic technique does not have to be followed For detailed sterile instructions refer to LifePort Kidney Transporter Disposable Perfusion Circuit Instructions For Use 1 Ensure Locking A...

Page 16: ...nd is not flowing through the Infuse Line 3 Press the STOP button to exit Wash Mode Prime 1 Press the PRIME button and observe that the flow diverts into the Infuse Line 2 Verify water is contained wi...

Page 17: ...t away from the product label 2 Insert the batteries 3 Replace the LifePort Kidney Transporter Battery Door 4 Verify the Outer Display shows that LifePort Kidney Transporter is plugged in and charging...

Page 18: ...ansporter to display 10 Scroll to DONE press OK and select SAVE External Communications using Data Station The Data Station is an optional software application that can be installed on a computer Data...

Page 19: ...ansporter 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 Prepare the Home...

Page 20: ...n it while driving The cart and supply packs can also be loaded onto the seats or into the trunk LifePort Kidney Transporter can withstand the normal handling involved in traveling between hospitals h...

Page 21: ...sing standard aseptic technique fill LifePort Kidney Transporter Disposable Perfusion Circuit with 1 Liter chilled 1 8 C perfusate 5 Using standard aseptic technique replace and secure Inner Perfusion...

Page 22: ...the ORGAN ID you wish to assign pressing OK with each selection 4 Scroll to DONE press OK and select SAVE to confirm 5 Select KIDNEY and press OK 6 Select LEFT or RIGHT as appropriate press OK and se...

Page 23: ...the Kidney Cradle and placed in LifePort Kidney Transporter Disposable Perfusion Circuit in LifePort Kidney Transporter Place the Kidney in Kidney Cradle WARNING The following procedure is performed...

Page 24: ...lowing procedure is performed on an aseptic field using standard aseptic technique 1 Connect the Infuse Line to the cannula on the Cannula Mount and tighten the Luer lock fitting 2 Remove the End Cap...

Page 25: ...Trap prior to entering the kidney The ice bath value will increase as the ice melts prompting the user to add more ice An audible alert and error message warning to Check Ice begins at 5 C If tempera...

Page 26: ...fePort Kidney Transporter Pressure Flow Resistance and Temperature It is normal to see flow increase while resistance decreases This indicates that the kidney is vasodilating LifePort Kidney Transport...

Page 27: ...orter 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 K...

Page 28: ...Mesh Organ Restraint 10 Using standard aseptic technique unstrap open and remove the cannula 11 Once the kidney has been removed from LifePort Kidney Transporter and accepted by the transplant surgeon...

Page 29: ...y kits should be repacked in preparation for the next transplant Data Capture and Download Optional Optionally data being generated and stored on LifePort Kidney Transporter can be downloaded and stor...

Page 30: ...er is not readily available for evaluating the data file you can download the file onto a flash drive and evaluate the data on a computer when one is available 1 Power on LifePort Kidney Transporter N...

Page 31: ...llow the instructions in Error Message Explanations If problem is not resolved please call Organ Recovery Systems 24 7 Perfusion Helpline Missing Incorrect Display Display or Internal Computer Error 1...

Page 32: ...n t Reach Pressure Leaking Cannula or Artery Leak in Perfusion Circuit Low Resistance Kidney 1 Under aseptic conditions visually inspect the connection to the cannulated kidney and correct any leaks i...

Page 33: ...re used to fill Ice Container 2 Move LifePort into a warmer environment If problem is not resolved call Organ Recovery Systems 24 7 Perfusion Helpline Occlusion Unexpected Pressures During Infuse Mode...

Page 34: ...ion 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 temperatu...

Page 35: ...d for several days or weeks thoroughly clean the device according to Clean and Disinfect After Use before storing LifePort Kidney Transporter should be stored indoors in a dry location out of direct s...

Page 36: ...Up to 24 hours between ice replenishment and battery replacement or recharge Batteries Four x 11 1 V lithium ion batteries Battery Life 24 hours fully charged Perfusate Used Hypothermic machine perfus...

Page 37: ...order new cables contact the Organ Recovery Systems 24 7 Perfusion Helpline CAUTION Use of Power Cords or communications cables other than those specified may result in increased emissions or decreas...

Page 38: ...EC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short inter...

Page 39: ...Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity o...

Page 40: ...e sterile as supplied Do not resterilize Connect the System to AC Mains According to Labeling LifePort Kidney Transporter uses externally supplied electricity to operate Check the voltage and amperage...

Page 41: ...the donor Use proper precautions e g gloves masks gowns goggles or equivalent eye protection biohazard bags in handling the kidney and in handling and disposing of the Perfusion Circuit and perfusate...

Page 42: ...approved cables and accessories may damage the system or interfere with accuracy For information contact the Organ Recovery Systems 24 7 Perfusion Helpline CAUTION Do not substitute the Power Cord Use...

Page 43: ...Disposal 7 Sterile Drape 7 19 20 23 Duration of Operation 12 E Electromagnetic Compliance 34 ENERGIZE 12 Enter Device Information 13 Enter ORGAN ID Information 17 Error Message Explanations 20 25 Exte...

Page 44: ...t Kidney Transporter for Recovery 15 Prepare the Home Base Station 14 pressure 3 4 5 8 11 12 14 19 20 21 24 26 28 30 Pressure Sensor Cable 5 8 10 16 27 Pressure Sensor Connector 8 10 16 26 pressure se...

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