LifePort Kidney Transporter 1.1 Operator'S Manual Download Page 39

755-00002 Rev R   

 

           

  LifePort Kidney Transporter Operator’s Manual

34

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.

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic  

Environment: Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

6 Vrms

ISM and Amateur Radio 

Bands

3 V/m

80 MHz to 2.5 GHz

3 V

6 V

3 V/m

Portable and mobile RF  

communications equipment 

should be used no closer to  

any part of LifePort Kidney  

Transporter, including cables, 

than the recommended  

separation distance calculated 

from the equation applicable to 

the frequency of the transmitter.

Recommended separation  

distance

                    150 kHz to 80 MHz

 

                     80 MHz to 800 MHz

                     800 MHz to 2.5 GHz

…where P is the maximum output 

power rating of the transmitter 

in watts (W) according to the 

transmitter manufacturer and d 

is the recommended separation 

distance in metres (m).

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 of equipment marked with 

the following symbol:

NOTE 1:

 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2:

 These guidelines may not apply in all situations. Electromagnetic 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 land mobile radios, amateur radio, AM and 

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. If abnormal 

performance is observed, additional measures may be necessary, such as reorienting or relocating LifePort Kidney Transporter. 

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

D=    3.5      P

           3

[ ]

D=    3.5      P

          3

[ ]

D=     7        P

        

  

3

[  ]

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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