Organ recovery systems LifePort Kidney Transporter LKT101P User manual

LifePort Kidney Transporter
Operator’s Manual 1.1

This Operator’s Manual references
LifePort Kidney Transporter
Model Number: LKT101P
2460
For technical assistance and to reorder supplies
and single use disposables, please contact:
Organ Recovery Systems Organ Recovery Systems NV ORS Representacoes do Brasil Ltda.
One Pierce Place, Ste 475W DaVincilaan 2, Box 6 170 MoemaAvenue, Suite 11 & 12
Itasca, IL 60143 1831 Diegem Sao Paulo, SP 04077-020
USA Belgium Brazil
T +1.847.824.2600 T +32.2.715.0000 T +55.11.3586.6259
F +1.847.824.0234 F +32.2.715.0009 F +55.11.3586.4944
Perfusion Helpline: Perfusion Helpline: Perfusion Helpline:
+1.866.682.4800 +32.2.715.0005 +55.11.98638.0086
www.organ-recovery.com
www.patents-organrecoverysystems.com
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
T +31.70.345.8570
F +31.70.346.7299
[email protected]
LifePort Kidney Transporter manufactured in the USA for Organ Recovery Systems.
©2018 Organ Recovery Systems, Inc. 10/2018
Made and printed in the USA.
LifePort Kidney Transporter Operator’s Manual 755-00002 Rev K
EC REP

755-00002 Rev K LifePort Kidney Transporter Operator’s Manual 3
Retain the following in your records:
Institution___________________________________________________________________
Contact____________________________________________________________________
Model Number______________________________________________________________
Serial Number______________________________________________________________
Date of Purchase____________________________________________________________

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev K
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Table of Contents
How To Use This Manual
Introduction……………………………………………………………………………………………………………..7
Purpose of Manual…………………………………………………………………………………………………….7
Abbreviations..…………………………………………………………………………………………………………8
System Description
Intended Use…………………………………………………………………………………………………………..9
Safety…………………………………………………………………………………………………………………...9
Physical Description…………………………………………………………………………………………………..9
Main Enclosure……………………………………………………………………………………………………10
Ice Container………………………………………………………………………………………………………10
Pump Deck………………………………………………………………………………………………………..10
Electronics…………………………………………………………………………………………………………11
External Communications………………………………………………………………………………...11
Circuit Breaker……………………………………………………………………………………………..11
Control Panel………………………………………………………………………………………………………11
Outer Display………………………………………………………………………………………………………12
LifePort Kidney Transporter Disposables………………………………………………………………………12
LifePort Kidney Transporter Disposable Kidney Perfusion Circuit.................………………………13
LifePort Kidney Transporter Disposable Kidney Cannulas…………………………………………...13
LifePort Kidney Transporter Disposable Kidney Sterile Drape……………………………………….13
Operational Accessories…………………………………………………………………………………………13
Power Cord………………………………………………………………………………………………………. 13
Batteries…………………………………………………………………………………………………………… 14
Battery Charger (Optional)……………………………………………………………………………………….14
Data Cable………………………………………………………………………………………………………...14
Perfusion Mode………………………………………………………………………………………………….. 15
Label Graphics Explanations…………………………………………………………………………………….15
Safe Disposal of LifePort and LifePort Batteries………………………………………………………………15
Unpacking, Setup and Preliminary Testing
Overview……………………………………………………………………………………………………………….16
Introduction…………………………………………………………………………………………………………….16
Selecting a Home Base Station…………………………………………………………………………………….16
Unpacking and Inspecting………………………………………………………………………………………….. 16
Running Preliminary Tests…………………………………………………………………………………………..16
Setting Up the LifePort Kidney Transporter …………………………………………………………………...17
Filling the Ice Container…………………………………………………………………………………………..17
Loading the Perfusion Circuit………………………………………………………….................…………….17
Energizing LifePort Kidney Trasporter………………………………………………………………………….18
Testing Operating Modes…………………………………………………………………………………………….18
Set Pressure………………………………………………………………………………………………………..18
Wash……………………………………………………………………………………………………………….. 19
Prime………………………………………………………………………………………………………………..19
Infuse………………………………………………………………………………………………………………..19

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Testing the Batteries…………………………………………………………………………………………………..20
Checking Duration of Operation (Optional)…………………………………………………………………………20
Entering Device Information………………………………………………………………………………………….20
External Communications using Data Station………………………………………………………………………20
GPS/GPRS Tracking Capability……………………………………………………………………………………...21
Cleaning Up and Review after Use …………………………………………………………………………………21
Using LifePort Kidney Transporter
Introduction…………………………………………………………………………………………………………….22
Professional Overview………………………………………………………………………………………………..22
Maintaining LifePort Kidney Transporter for Quick Response Use………………………………………………22
Preparing the Home Base Station……………………………………………………………………………….22
Preparing LifePort Kidney Transporter for Recovery………………………………………………………………23
Cooling Down LifePort Kidney Transporter……………………………………………………………………..23
Traveling with LifePort Kidney Transporter and Supplies……………………………………………………..23
Setting Up the Disposable Kidney Perfusion Circuit…………………………………………………………...24
Isolating the Kidney Vascular Structure……………………………………………………………………………..27
Cannulating the Kidney……………………………………………………………………………………………….28
Using the Disposable Kidney SealRing®cannula……..……………………………………………………….28
Using the Disposable Kidney Straight cannula…………………………………………………………………29
Using the Disposable Kidney Coupler…………………………………………………………………………...30
Using the Disposable Kidney Universal SealRing®cannula…..………………………………………………32
Placing the Kidney in LifePort Kidney Transporter…………………………………………………………………34
Entering ORGAN ID Information…………………………………………………………………………………34
Placing the Kidney…………………………………………………………………………………………………35
Priming the Infuse Line…………………………………………………………………………………………...36
Preliminary Testing for Leaks…………………………………………………………………………………….37
Initiating Perfusion…………………………………………………………………………………………………38
Checking the Kidney After Placement………………………………………………………………………………38
Visual Inspection…………………………………………………………………………………………………..38
Cannula Leakage?…………………………………………………………………………………………………38
Artery Filled?……………………………………………………………………………………………………….38
Side Branches Closed?……………………………………………………………………………………………39
Vein Positioned on Top?………………………………………………………………………………………….39
Presence of Blood or Perfusate?…………………………………………………………………………………39
Color of Kidney?……………………………………………………………………………………………………39
Closing LifePort Kidney Transporter…………………………………………………………………………………40
Monitoring Options for a Kidney on LifePort Kidney Trasporter………………………………………………….40
Monitoring Via LifePort Kidney Transporter Outer Display……………………………………………………41
Data Station Monitoring……………………………………………………………………………………………42
GPS/GPRS Tracking……………………………………………………………………………………………….42
Typical Behavior of a Kidney on LifePort Kidney Transporter………………………………………………...43
Leakage at Cannula or Open Side Branch………………………………………………………………….43
Nonresponding Kidney…………………………………………………………………………………..........43
Remote Monitoring…………………………………………………………………………………………………44
Preparing to Travel to the Transplant Site…………………………………………………………………………. 44
Transplant from the Recovery Site…………………………………………………………………………….. 44
Transport the LifePort Kidney Transporter and Supplies……………………………………………………..44

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Delivering to the Transplant OR…………………………………………………………………………………….. 44
Checking Battery Power and Ice……………………………………………………………………………….... 44
Adding More Ice………………………………………………………………………………………………........44
Replacing Batteries…………………………………………………………………………………………….......44
At the Transplant OR ……………………………………………………………………………………………...45
Waiting until Recipient Surgery Is Ready.……………………………………………………………………….45
Removing the Kidney from LifePort Kidney Transporter for Transplant.…………………………………….45
Capturing and Downloading Data (Optional)……………………………………………………………………48
Introduction………………………………………………………………………………………………….48
To Flash Drive……………………………………………………………………………………………….49
Downloading a File……………………………………………………………………………………. 49
Troubleshooting and Diagnostics
Troubleshooting Procedures………………………………………………………………………………………50
Error Message Explanations……………………………………………………………………………………...51
Power On Self Test (POST)………………………………………………………………………………………54
Maintenance
Overview……………………………………………………………………………………………………………55
Cleaning Up after a Case ………………………………………………………………………………………...55
Storage.……………………………………………………………………………………………………………..55
Shipping by Common Carrier …………………………………………………………………………………….55
Specications, Precautions, Limitations
Product Specications…………………………………………………………………………………………….56
Device Classications……………………………………………………………………………………………..57
Electromagnetic Compatibility……………………………………………………………………………………57
Operational Precautions and Limitations………………………………………………………………………..60
Hazards
Overview……………………………………………………………………………………………………………62

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How To Use This Manual
Introduction
It is important that all personnel who will operate the LifePort Kidney Transporter (LifePort) should:
• Read and understand this manual before operating the LifePort Kidney Transporter.
• Follow all warnings and precautions outlined in the sections Operational Precautions and
Limitations on page 60 and Hazards on page 62 for their own safety and the safety of those
around them.
LifePort Kidney Transporter is intended to be used for the hypothermic machine perfusion of kidneys. If
more information is needed about installation, organ perfusion or if you have any questions, please
contact the Organ Recovery Systems Perfusion Helpline.
Purpose of Manual
The instructions within this manual should be carefully followed for safe, trouble-free and e󰀨ective
equipment use.
This manual provides the essential information necessary for installation, operation and routine servicing
of LifePort Kidney Transporter. It contains important operation and maintenance information for personnel
who have been trained in organ perfusion.
This manual is NOT to be used as a replacement for training in the art or science of organ perfusion.
This manual does NOT contain information for servicing internal components of the system.
In this manual, the following denitions apply for all WARNING and CAUTION statements.
WARNING: A warning statement covers any operation, procedure, practice, etc., which if not strictly
observed, might result in injury or long-term health hazards to personnel or patients.
CAUTION: A caution statement covers any operation, procedure, practice, etc., which if not strictly
observed, might result in damage or destruction of equipment or loss of treatment e󰀨ectiveness.

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Abbreviations
The abbreviations used in this manual are listed and dened in the following table.
A Amperes
AC Alternating current
A-hr Ampere-hours
°C Degrees Celsius
cm Centimeter (1 cm = .01 m)
L Liter (1L =0.001 m3)
lb(s) Pound (1 lb = 0.45 kg)
LCD Liquid Crystal Display
LED Light Emitting Diode
kg Kilogram (1 kg = 2.2 lbs)
mL/min Milliliters per minute (1 mL/min = 0.00006 m3/sec)
mmHg Millimeters of mercury (1 mmHg = 1 Torr = 133.3 Pa)
V Volts

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System Description
Intended Use
LifePort Kidney Transporter is intended for use in continuous hypothermic machine perfusion of kidneys.
Safety
The responsibility for safety when using LifePort Kidney Transporter resides within the healthcare
professionals who use it. LifePort Kidney Transporter is safe when used as described in this manual. It
is designed to meet recognized U.S. and International standards for medical equipment and systems, as
stated by the Underwriters Laboratories and the International Electro-technical Commission.
Electrical and mechanical safety features have been designed into LifePort Kidney Transporter to ensure
safe operation.
These features are as follows:
• The electrical and electronic components are contained within a secure enclosure.
• Perfusate temperature, ow rates and pressure levels are only adjustable within a set range,
which cannot be changed by the operator.
• Perfusate pressure, ow rate and temperature are continuously monitored.
• Display screens illuminate when the power is on. Stop, Wash, Prime and Infuse controls are
provided and identied, depending on the mode and options available.
• Acceptable operating ranges are established within LifePort Kidney Transporter for pressure,
temperature, ow rate, battery charge state, bubbles in the perfusate and conguration integrity.
Hard-wired and software interlocks are built-in to bring LifePort Kidney Transporter to a failsafe
condition if an unacceptable operating state is detected.
• An audible alert and a descriptive message are given by LifePort Kidney Transporter if an
unacceptable
operating state is detected.
Physical Description
LifePort Kidney Transporter is a portable transport device designed to maintain a transplantable kidney
under cold and aseptic conditions, while simultaneously perfusing it. An insulated, plastic housing
encloses the kidney and perfusate within a disposable Perfusion Circuit. LifePort Kidney Transporter’s
components also include an Ice Container, Pump Deck, four lithium-ion batteries, electronics, Bubble
Detectors, sensors, Control Panel and an Outer Display.
Ice Container
Ice Container Pump Deck
Bubble
Detectors
Infusion
Pump
Control Panel
Safety Latch
Insulating Cover
Ergonomic
Handles
Outer Display

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LifePort Kidney Transporter is designed to integrate with the clinical environment by using readily
available supplies, requiring minimal user intervention, and by being easy to use.
Once the Ice Container is properly loaded, even when LifePort Kidney Transporter is powered o󰀨, it
preserves kidneys hypothermically to the same degree as conventional static (ice-pack) storage methods.
Main Enclosure
LifePort Kidney Transporter is enclosed in a rugged, insulated plastic housing designed for easy carrying.
The lower section contains an Ice Container, Perfusion Circuit, Pump Deck, batteries, electronics,
sensors, Bubble Detectors, Control Panel, Outer Display and Disposables. Two handles make the unit
easy to lift and carry.
An insulated, removable, latched Lid covers the lower housing during perfusion to keep the kidney secure
and at the proper temperature.
Ice Container
The Ice Container is a sealed enclosure with a removable lid, which is lled with a mixture of ice and
water to provide a stable cold temperature environment for the kidney.
Pump Deck
The Pump Deck is the uid management area of LifePort Kidney Transporter. On the Pump Deck, the
Perfusion Circuit tubing traverses a peristaltic pump, valves and sensors, which control the pressure,
speed and routing of the perfusate.
• Infusion Pump—A peristaltic pump that propels perfusate through the kidney. By moving rollers
against the Pump Tubing, the Pump pushes the perfusate through the kidney, while keeping it sealed
within the Perfusion Circuit. LifePort Kidney Transporter electronics regulate pump speed to control
perfusion pressure.
• Bubble Detectors—Two non-contact Bubble Detectors on the Pump Deck check the perfusate to
prevent bubbles from entering the kidney.
The rst Bubble Detector is located upstream of the Bubble Trap and Wash Line and diverts detected
bubbles away from the kidney and into the Wash Line, after which LifePort Kidney Transporter will
resume perfusing.
The second Bubble Detector is located immediately before the kidney and prevents detected bubbles
from entering the kidney by stopping perfusion altogether.
Pump Deck
Bubble
Detectors
Infusion Pump