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LifePort Kidney Transporter 1.1

Operator’s Manual

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Содержание Kidney Transporter 1.1

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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