Organ recovery systems LifePort Kidney Transporter LKT100P User manual

LifePort Kidney Transporter
Operator’s Manual 1.0

This Operator’s Manual references
LifePort Kidney Transporter
Model Number: LKT100P
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.
LifePort Kidney Transporter Operator’s Manual 755-00029 Rev H

755-00029 Rev H 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 755-00029 Rev H
4
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
Control Panel……………………………………………………………………………………………………….11
Outer Display……………………………………………………………………………………………………….12
LifePort Disposables…………………………………………………………………………………………………..12
LifePort Perfusion Circuit (Cassette)…………………………………………………………………………….12
LifePort Disposable Cannulas…………………………………………………………………………………….13
LifePort Sterile Drape………………………………………………………………………………………………13
OperationalAccessories………………………………………………………………………………………………13
Power Cord………………………………………………………………………………………………………...13
Batteries……………………………………………………………………………………………………………..13
Battery Charger (Optional)………………………………………………………………………………………..14
Data Cable…………………………………………………………………………………………………………..14
Perfusion Mode………………………………………………………………………………………………………..14
Label Graphics Explanations……………………………………………………………………………………..15
Safe Disposal of 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…………………………………………………………………………………………….17
Setting Up the LifePort…………………………………………………………………………………………………17
Filling the Ice Container……………………………………………………………………………………………..17
Loading the Perfusion Circuit (Cassette)……………………………………………………………………….....17
Energizing the LifePort……………………………………………………………………………………………...18
Testing Operating Modes…………………………………………………………………………………………...19
Testing the Batteries……………………………………………………………………………………………….19
Checking Duration of Operation (Optional)……………………………………………………………………..20
Setting up External Communications using Data Station……………………………………………………..20
Cleaning Up and Review after Use……………………………………………………………………………...21

755-00029 Rev H LifePort Kidney Transporter Operator’s Manual 5
Using the LifePort
Introduction……………………………………………………………………………………………………………..22
Professional Overview…………………………………………………………………………………………………22
Maintaining the LifePort for Quick Response Use………………………………………………………………….22
Preparing the Home Base Station………………………………………………………………………………..22
Preparing the LifePort for Recovery………………………………………………………………………………….23
Cooling Down the LifePort………………………………………………………………………………………............23
Traveling with the LifePort and Supplies………………………………………………………………………...24
Setting Up the Kidney Perfusion Circuit (Cassette)…………………………………………………………….24
Isolating the Kidney Vascular Structure……………………………………………………………………………...26
Cannulating the Kidney………………………………………………………………………………………………..27
Using the Straight Cannula………………………………………………………………………………………..27
Using the SealRing®Cannula……………………………………………………………………………………..28
Using the Coupler…………………………………………………………………………………………………..30
Using the Universal SealRing®………………………………………………...…………………………………..32
Placing the Kidney in the LifePort……………………………………………………………………………………33
Priming the Infuse Line………………………………………………………………………………………………. 35
Preliminary Testing for Leaks……………………………………………………………………………………..36
Initiating Perfusion………………………………………………………………………………………………….37
Checking the KidneyAfter Placement……………………………………………………………………………….37
Visual Inspection……………………………………………………………………………………………………37
Cannula Leakage?……………………………………………………………………………………………..37
Artery Filled?…………………………………………………………………………………………………….37
Side Branches Closed?……………………………………………………………………………………….. 37
Vein Positioned on Top?……………………………………………………………………………………….38
Presence of Blood or Perfusate?……………………………………………………………………………..38
Color of Kidney?………………………………………………………………………………………………..38
Closing the LifePort……………………………………………………………………………………………………38
Monitoring Options for a Kidney on the LifePort……………………………………………………………………39
Monitoring via LifePort Outer Display…………………………………………………………………………....39
Data Station Monitoring……………………………………………………………………………………………41
Typical Behavior of a Kidney on LifePort……………………………………………………………………………42
Leakage at Cannula or Open Side Branch……………………………………………………………………...42
Nonresponding Kidney…………………………………………………………………………………………….43
Remote Monitoring…………………………………………………………………………………………………43
Preparing to Travel to the Transplant Site…………………………………………………………………………. 43
Delivering to the Transplant OR…………………………………………………………………………………….. 43
Checking Battery Power and Ice………………………………………………………………………………... 43
Adding More Ice………………………………………………………………………………………………..44
Replacing Batteries…………………………………………………………………………………………….44
At the Transplant OR……………………………………………………………………………………………... 44
Waiting until Recipient Surgery Is Ready……………………………………………………………………………44
Removing the Kidney from the LifePort for Transplant…………………………………………………………….45
Downloading Operational Data (optional)…………………………………………………………………………..48
Introduction………………………………………………………………………………………………………….48

LifePort Kidney Transporter Operator’s Manual 755-00029 Rev H
6
Troubleshooting and Diagnostics
Troubleshooting Procedures………………………………………………………………………………………….49
Error Message Explanations………………………………………………………………………………………….50
Power On Self Test (POST)………………………………………………………………………………………….. 53
Maintenance
Overview………………………………………………………………………………………………………………...54
Cleaning Up after a Case…………………………………………………………………………………………….. 54
Storage………………………………………………………………………………………………………………….54
Shipping by Common Carrier…………………………………………………………………………………………55
Specications, Precautions, Limitations
Product Specications…………………………………………………………………………………………………55
Device Classications………………………………………………………………………………………………….56
Electromagnetic Compatibility………………………………………………………………………………………...56
Operational Precautions and Limitations…………………………………………………………………………….60
Hazards
Overview………………………………………………………………………………………………………………...62

755-00029 Rev H LifePort Kidney Transporter Operator’s Manual 7
How To Use This Manual
Introduction
It is important that all personnel who will operate the LifePort Kidney Transporter (LifePort):
• Read and understand this manual before operating the LifePort.
• Follow all warnings and precautions outlined in the sections Specications, Precautions and
Limitations on page 55, and Hazards on page 62 for their own safety and the safety of those
around them.
The LifePort 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 Organ
Recovery Systems Perfusion Helpline.
Purpose of Manual
The instructions within this manual should be carefully followed for safe, trouble-free, and effective
equipment use.
This manual provides the essential information necessary for installation, operation, and routine servicing
of the LifePort. 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
effectiveness.

LifePort Kidney Transporter Operator’s Manual 755-00029 Rev H
8
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

755-00029 Rev H LifePort Kidney Transporter Operator’s Manual 9
System Description
Intended Use
The LifePort is intended for use in continuous hypothermic machine perfusion of kidneys.
Safety
The responsibility for safety when using LifePort resides within the healthcare professionals who use it.
The LifePort 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 the LifePort 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.
• A power indicator light is provided to indicate when the unit is powered on. Stop, Wash, Prime
and Infuse lights are provided to indicate whether the LifePort is stopped, washing, priming, or
infusing.
• Acceptable operating ranges are established within the LifePort 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 the LifePort to a failsafe condition if an unacceptable
operating state is detected.
• An error light, audible alert and descriptive message are given by the LifePort if an unacceptable
operating state is detected.
Physical Description
The LifePort is a portable transport device designed to maintain a transplantable kidney under cold and
aseptic conditions, while perfusing it at the same time. An insulated, plastic housing encloses the kidney
and perfusate within a disposable Perfusion Circuit (Cassette). The LifePort’s components also include
an Ice Container, Pump Deck, four lithium-ion batteries, electronics, Bubble Detectors, a 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

LifePort Kidney Transporter Operator’s Manual 755-00029 Rev H
10
The LifePort 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 the LifePort is powered off, it preserves kidneys
hypothermically to the same degree as conventional static (ice-pack) storage methods.
Main Enclosure
The LifePort is enclosed in a rugged, insulated plastic housing designed for easy carrying. The lower
section contains an Ice Container, Perfusion Circuit (Cassette), 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 Cover encloses 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 the LifePort. On the Pump Deck, the Perfusion Circuit
(Cassette) 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 (Cassette). The LifePort 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 the LifePort 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