Organ recovery systems LifePort Kidney Transporter Operator'S Manual Download Page 5 | Manualshive

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755-00002 Rev P

LifePort Kidney Transporter Operator’s Manual

iv

Maintenance

Overview........................................................................................................................................................... 31

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

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Summary of Contents for LifePort Kidney Transporter

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

Page 2: ...32 2 715 0000 T 55 11 98638 0086 F 1 847 824 0234 F 32 2 715 0009 Perfusion Helpline Perfusion Helpline Perfusion Helpline 1 866 682 4800 32 2 715 0005 55 11 98638 0086 33 9 6723 0016 34 910 91 16 16...

Page 3: ...t Batteries 7 LifePort Kidney Transporter Disposable Products 7 LifePort Kidney Transporter Disposable Cannulas 7 LifePort Kidney Transporter Disposable Sterile Drape 7 LifePort Kidney Transporter Dis...

Page 4: ...versal SealRing 18 LifePort Kidney Transporter Disposable SealRing Cannula 18 LifePort Kidney Transporter Disposable Straight Cannula 19 LifePort Kidney Transporter Disposable Coupler 19 Place the Kid...

Page 5: ...s Manual iv Maintenance Overview 31 Storage 31 Repairs 31 Specifications Precautions Limitations Product Specifications 32 Device Classifications 32 Electromagnetic Compatibility 33 Operational Precau...

Page 6: ...Organ Recovery Systems 24 7 Perfusion Helpline see inside front cover for contact details In this manual the following definitions apply for all WARNING and CAUTION statements WARNING A warning state...

Page 7: ...structions for Use Manufacturer Use By YYYY MM DD Date of Manufacture YYYY MM DD Keep Dry Keep Away From Sunlight Electric Shock Hazard Prescription Medical Device IPX1 Protected against falling water...

Page 8: ...stablished within LifePort Kidney Transporter for pressure temperature flow rate battery charge state bubbles in the perfusate and configuration integrity Hard wired and software interlocks are built...

Page 9: ...d lines of values for flow and resistance The temperature display shows the temperatures of the Ice Container as read at a sensor located near the Ice Container and the temperature of the perfusate as...

Page 10: ...nd displays an error message Bubble Detectors Two non contact Bubble Detectors check the perfusate to prevent bubbles from entering the kidney One is located upstream of the Perfusion Circuit Bubble T...

Page 11: ...ble connects LifePort Kidney Transporter to an external computer The USB A end connects to the Data Port on the LifePort and the USB B end connects to the USB port of a personal computer Batteries Lif...

Page 12: ...LifePort Kidney Transporter or LifePort Kidney Transporter batteries call the Organ Recovery Systems 24 7 Perfusion Helpline to arrange for pickup from your facility LifePort Kidney Transporter Dispo...

Page 13: ...e Tubeframe Plastic frame that positions the tubing around the Infusion Pump valves and sensors of the Pump Deck Tubing Circuit The sealed fluid pathway that draws perfusate from the Organ Cassette fo...

Page 14: ...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 rooms...

Page 15: ...ing 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...

Page 16: ...is contained in the tubing without leaking and 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 th...

Page 17: ...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 4 Verify the Ou...

Page 18: ...site portal Using the LifePort Kidney Transporter Portal users can Locate track and view an entire history of travel for LifePort Kidney Transporter Read information from LifePort Kidney Transporter s...

Page 19: ...ck 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 Base Station Lif...

Page 20: ...ain 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...

Page 21: ...t 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 techniqu...

Page 22: ...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 select SAVE to confirm 7 Select BLOOD TYPE and press OK 8 Select t...

Page 23: ...g 5 Lower the upper portion of Universal SealRing while carefully bringing the conical seal into the interior of the vessel NOTE Viewing through the magnified sight glass verify that the vessel orific...

Page 24: ...sel loops or another appropriate material A groove in the tip is provided for positioning and securing LifePort Kidney Transporter Disposable Coupler INDICATIONS FOR USE The Coupler is used to connect...

Page 25: ...Where noted perform the following procedure on an aseptic field using standard aseptic technique A person outside the sterile field should perform the following Remove the LifePort Kidney Transporter...

Page 26: ...ay originate from the cannulation site or arteries or from the Perfusion Circuit There are two types of leaks to look for A Leaks from the cannulation site or artery Identify and address any leaks B L...

Page 27: ...Port Kidney Transporter is operating on AC or battery power NOTE If LifePort Kidney Transporter is connected to a power source but is not operating the front panel will display an electric plug icon i...

Page 28: ...ph shows immediate flow but no build up of resistance This can indicate a leak at the cannula site or an open lateral branch of the renal artery Nonresponsive Kidney A nonresponsive kidney not respond...

Page 29: ...rvation on LifePort Kidney Transporter NOTE LifePort Kidney Transporter will alert when the batteries have two hours remaining or when the temperature in the Ice Container reaches 8 C Add More Ice Che...

Page 30: ...e transplant preparation on the kidney 12 Once the kidney has been removed from the LifePort Kidney Transporter and accepted by the transplant surgeon proceed to Clean Up After A Case Clean Up After A...

Page 31: ...tolic and diastolic pressures Flow rate Organ resistance Ice Container temperature Bubble Trap temperature Error condition status presence or absence of each error condition Perfusion system state and...

Page 32: ...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 Powe...

Page 33: ...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 34: ...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 35: ...sion 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 temperat...

Page 36: ...ccording to Clean Up After A Case before storing LifePort Kidney Transporter should be stored indoors in a dry location out of direct sunlight For periods of storage for longer than 30 days remove the...

Page 37: ...ey Transporter is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation optional transportation and eventual transplantation into a recipient Capacity Si...

Page 38: ...Part AK67222 Power Cord Part 17664 US only contact the Organ Recovery Systems 24 7 Perfusion Helpline for international Power Cord part numbers WARNING Use of Power Cords or communications cables oth...

Page 39: ...1000 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 interrupt...

Page 40: ...etic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and...

Page 41: ...ssionals Federal law restricts the sale of this device to physicians and medical professionals only Use of the device in procedures other than those described in this manual may result in injury Do No...

Page 42: ...idney Transporter needs special precautions regarding EMC and should be used in accordance with the EMC information provided in this manual Please refer to Electromagnetic Compatibility for details Ai...

Page 43: ...l Precautions with the kidney and perfusate The kidney and perfusate may carry undetected pathogens from the donor Use proper precautions e g gloves masks gowns goggles or equivalent eye protection bi...

Page 44: ...23 DEVICE INFORMATION 12 13 Disposable Products 7 25 Disposal 7 Sterile Drape 7 20 21 25 Duration of Operation 12 E Electromagnetic Compliance 37 ENERGIZE 12 Enter Device Information 13 Enter ORGAN I...

Page 45: ...sure 3 4 5 8 11 12 14 21 22 23 26 28 30 32 Pressure Sensor Cable 5 8 10 16 29 Pressure Sensor Connector 8 10 16 28 pressure setting 21 PRIME 5 10 11 21 22 Pump Deck 3 4 5 8 10 16 20 25 38 Pumphead Rac...

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