LifePort Kidney Transporter 1.1 Operator'S Manual Download Page 37

755-00002 Rev R   

 

           

  LifePort Kidney Transporter Operator’s Manual

32

Electromagnetic Compatibility

LifePort Kidney Transporter needs special precautions regarding electromagnetic compatibility (EMC)  

and should be used in accordance with the EMC information provided in this manual.

LifePort Kidney Transporter can radiate radio frequency energy and, if not installed and used in 

 

accordance with the instructions, may cause harmful interference to radio or television reception.  

However, there is no guarantee that the interference will not occur in a particular installation. LifePort Kidney 

Transporter does cause interference, which can be determined by turning LifePort Kidney  

Transporter on and off. Try to correct the interference by one or more of the following measures:

•  Reorient the receiving antenna.

•  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.

CAUTION:

 To assure compliance with EMC requirements, use only manufacturer-supplied cables. If you 

have questions or would like to 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 decreased immunity of LifePort Kidney Transporter. 

CAUTION: 

LifePort Kidney Transporter should not be used adjacent to or stacked with other  

equipment and if adjacent or stacked use is necessary, LifePort Kidney Transporter should be 

 

observed to verify normal operation in the configuration in which it will be used. 

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

RF emissions

CISPR11

Group 1

LifePort Kidney Transporter uses  

RF energy only for its internal  

function. Therefore, its RF  

emissions are very low and are not 

likely to cause any interference in 

nearby electronic equipment.

RF emissions

CISPR11

Class B

The LifePort is suitable for use in all 

establishments, other than domestic 

establishments and those directly  

connected to the public low-voltage 

power supply network that supplies 

buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/flicker 

 

emissions

IEC 61000-3-3

Complies

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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