LifePort Kidney Transporter 1.1 User manual

LifePort Kidney Transporter 1.1
Operator’s Manual

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
i
This Operator’s Manual references
LifePort Kidney Transporter
Model Numbers:
LKT101P
LKT101PNG
For technical assistance, please call Organ
Recovery Systems 24/7 Perfusion Helpline at one
of the numbers listed below.
For customers in the US, Canada, Asia, Australia, and New Zealand, please call our USA o󰀩ce.
For customers in Europe, Africa, and the Middle East, please call our Belgium o󰀩ce.
For customers in South and Central America, please call our Brazil o󰀩ce.
www.organ-recovery.com
www.patents-organrecoverysystems.com
LifePort Kidney Transporter manufactured in the USA for Organ Recovery Systems, Inc.
© 2022 Organ 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
SPONSOR
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
CH REP
MedEnvoy UK Limited
85, Great Portland Street, First Floor
London, W1W 7LT
United Kingdom
UK RESPONSIBLE
PERSON
MedEnvoy Switzerland
Gotthardstrasse 28
6302 Zug
Switzerland
Organ Recovery Systems, Inc.
One Pierce Place, Ste 475W
Itasca, IL 60143
USA
T +1.847.824.2600
F +1.847.824.0234
Perfusion Helpline:
+1.866.682.4800
Organ Recovery Systems NV
Culliganlaan 1B
1831 Diegem
Belgium
T +32.2.715.0000
F +32.2.715.0009
Perfusion Helpline:
+32.2.715.0005
+33.9.6723.0016
ORS Representacoes do Brasil Ltda.
170 Moema Avenue, Suite 11 & 12
Sao Paulo, SP 04077-020
Brazil
T +55.11.98638.0086
Perfusion Helpline:
+55.11.98638.0086

755-00002 Rev R LifePort Kidney Transporter Operator’s Manual ii
Table of Contents
Introduction
Purpose of Manual ............................................................................................................................................. 1
Abbreviations...................................................................................................................................................... 1
Label Graphics Explanations.............................................................................................................................. 2
System Description
Intended Use ...................................................................................................................................................... 3
Indications for Use.............................................................................................................................................. 3
Safety ................................................................................................................................................................. 3
Contraindications................................................................................................................................................ 3
Physical Description ........................................................................................................................................... 3
Ice Container.................................................................................................................................................. 4
Control Panel ................................................................................................................................................. 4
Outer Display ................................................................................................................................................. 4
Pump Deck..................................................................................................................................................... 5
Cover.............................................................................................................................................................. 5
External Connections Panel........................................................................................................................... 6
Operational Accessories..................................................................................................................................... 6
Power Cord .................................................................................................................................................... 6
Data Cable .................................................................................................................................................... 6
Batteries ......................................................................................................................................................... 6
Safe Disposal of LifePort Kidney Transporter 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 Transporter Disposable Perfusion Circuit ............................................................................. 8
Unpack, Setup, and Run Preliminary Tests
Overview............................................................................................................................................................. 9
Introduction......................................................................................................................................................... 9
Select a Home Base Station .............................................................................................................................. 9
Unpack and Inspect............................................................................................................................................ 9
Run Preliminary Tests......................................................................................................................................... 9
Set Up LifePort Kidney Transporter ............................................................................................................. 10
Fill the Ice Container .............................................................................................................................. 10
Load LifePort Kidney Transporter Disposable Perfusion Circuit ............................................................ 10
Energize the LifePort Kidney Transporter .................................................................................................... 10
Test Operating Modes...................................................................................................................................11
Set Pressure............................................................................................................................................11
Wash .......................................................................................................................................................11
Prime.......................................................................................................................................................11
Infuse.......................................................................................................................................................11
Test Batteries ............................................................................................................................................... 12
Check Duration of Operation (Optional) ...................................................................................................... 12

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
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Enter Device Information...................................................................................................................................13
External Communications using Data Station ...................................................................................................13
Clean Up and Review After Use........................................................................................................................13
LifePort Kidney Transporter Use
Introduction........................................................................................................................................................14
Professional Overview.......................................................................................................................................14
Maintain LifePort Kidney Transporter for Quick Response Use ........................................................................14
Prepare the Home Base Station ...................................................................................................................14
Prepare LifePort Kidney Transporter for Recovery .......................................................................................15
Travel with LifePort Kidney Transporter and Supplies ..................................................................................15
Fill LifePort Kidney Transporter Ice Container...................................................................................................15
Load LifePort Kidney Transporter Disposable Perfusion Circuit........................................................................16
Enter ORGAN ID Information ............................................................................................................................17
Isolate the Kidney Vascular 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 Parameters.................................................................................................................................20
Data Station Monitoring.................................................................................................................................21
Kidney Behavior on LifePort Kidney Transporter ..........................................................................................21
Leaks at the Cannula or Open Side Branch............................................................................................21
Nonresponsive Kidney ............................................................................................................................21
Remote Monitoring........................................................................................................................................22
Traveling with LifePort Kidney Transporter........................................................................................................22
Rell Ice / Swap Batteries..................................................................................................................................22
Add More Ice.................................................................................................................................................22
Replace Batteries..........................................................................................................................................22
Remove Kidney From LifePort Kidney Transporter ...........................................................................................23
Clean and Disinfect After Use............................................................................................................................23
Data Capture and Download (Optional) ............................................................................................................24
Using A Computer .........................................................................................................................................24
Using A Flash Drive.......................................................................................................................................25
Troubleshooting and Diagnostics
Troubleshooting Procedures .............................................................................................................................25
Error Message Explanations .............................................................................................................................26
Power On Self Test (POST)...............................................................................................................................29
Maintenance
Overview............................................................................................................................................................30
Storage..............................................................................................................................................................30
Repairs ..............................................................................................................................................................30

755-00002 Rev R LifePort Kidney Transporter Operator’s Manual iv
Specications, Precautions, Limitations
Product Specications...................................................................................................................................... 31
Device Classications....................................................................................................................................... 31
Electromagnetic Compatibility .......................................................................................................................... 32
Hazards
Overview........................................................................................................................................................... 36

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
1
Introduction
Purpose of Manual
This manual provides the essential information necessary for installation, operation, and routine care of
LifePort Kidney Transporter. The instructions within this manual should be carefully followed for safe and
e󰀨ective equipment use. It contains important operation and maintenance information for personnel trained to
use this device.
It is important that all personnel who will operate LifePort Kidney Transporter:
• Read and understand this manual before device operation.
• Follow all warnings and precautions outlined in the sections Operational Precautions and Limitations
and Hazards for their own safety and the safety of those around them.
This manual is NOT to be used as a replacement for training in the practice or science of organ perfusion.
Specic practice regarding machine perfusion of kidneys recovered from pediatric donors, or donor kidneys
intended for pediatric recipients, must be conducted according to the protocols specied by the transplant
physician and institution policies. This manual does NOT contain information 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 Systems 24/7 Perfusion Helpline.
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 serious 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 mild or moderate injury or damage or destruction of equipment or loss of
performance.
Abbreviations
The abbreviations used in this manual are listed and dened in the following table.
A Ampere
AC Alternating Current
°C Degrees Celsius
cm Centimeter (1 cm = .01 m)
EMC Electromagnetic compatibility
EU MDD European Union Medical Device Directive
FCC Federal Communications Commission
FDA Food and Drug Administration
Hz Hertz
ID Identication or Identication Number
IEC International Electrotechnical Commission
IR Infrared
lb(s) Pound (1 lb = 0.45 kg)
kg Kilogram (1 kg = 2.2 lbs)
LKT LifePort Kidney Transporter
mL/min Milliliters per minute
mmHg Millimeters of mercury (1 mmHg = 1 Torr = 133.3 Pa)
RF Radio Frequency
V Volts

755-00002 Rev R LifePort Kidney Transporter Operator’s Manual 2
Label Graphics Explanations
The following table provides an explanation of the label graphics for LifePort Kidney Transporter system.
Warning/Caution Do Not Reuse
Lot Number Do Not Resterilize
Serial Number Temperature limits
Reference Number Sterilized Using Aseptic Fill
STERILE
STERILE
EO
EO
Sterilized Using Ethylene Oxide Consult Instructions 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.
Power button/standby power Circuit breaker. Push to reset.
Data Port (USB) Interference may occur in the vicinity of
equipment.
Battery slot graphic showing slot numbering
and insertion orientation.
Medical – General medical equipment as to
electrical shock, re and mechanical hazards
in accordance with ANSI/AAMI ES60601-1.
Medical Device Country of Origin
Importer Single Sterile Barrier System
Single Sterile Barrier with protective packaging inside for aseptic eld
REF
REF
S
S
N
N
13
2
STERILIZE
STERILIZE
2
STERILE
STERILE
A
A
5

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
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System Description
Intended Use
LifePort Kidney Transporter (LKT) is intended for use in continuous hypothermic machine perfusion of kidneys.
Indications for Use
LifePort Kidney 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.
Safety
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 (UL) and the International Electrotechnical Commission (IEC).
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 of operation 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.
Hardware and software interlocks are built-in to bring LifePort Kidney Transporter to a fail-safe condition
if an unacceptable operating state is detected.
• LifePort Kidney Transporter gives an audible alert and a descriptive message if an unacceptable
operating state is detected.
Contraindications
There are no known contraindications when used as directed.
Physical Description
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. LifePort Kidney Transporter is a
portable, isolated kidney perfusion and transport system, designed to support a donated kidney and to
maintain the organ in a near-normal physiologic state under hypothermic aseptic conditions. An insulated
plastic housing encloses the kidney and perfusate within a LifePort Kidney Transporter Disposable Perfusion
Circuit. LifePort Kidney Transporter components include an Ice Container, Pump Deck, Control Panel, Outer
Display, Bubble Detectors, External Connections Panel, sensors, and four lithium-ion batteries. Two handles
make the unit easy to lift and carry.

755-00002 Rev R LifePort Kidney Transporter Operator’s Manual 4
Ice Container
LifePort Kidney Transporter
Disposable Perfusion Circuit
Pump Deck
Control Panel
Insulating Cover
Outer Display
Ice Container
A molded thermoplastic Ice Container with a removable lid is designed to be lled with a recommended mixture
of ice and water to provide a hypothermic temperature environment for the donor kidney.
With the Ice Container properly loaded, LifePort Kidney Transporter preserves kidneys hypothermically to the
same degree as conventional static storage methods, even when powered o󰀨.
Control Panel
The Control Panel is located next to the Pump Deck. The panel can be accessed only when the Cover is
removed, which prevents inadvertent and unauthorized access to the controls. The left screen displays the
current pressure setpoint and the operational mode. The right screen displays user-entered information.
POWER
Off / On
RAISE AND LOWER
infusion pressure (by
1-mmHg increments)
PRESSURE SETPOINT
(default 30 mmHg)
DATA ENTRY /
DISPLAY screen
5-WAY KEYPAD
(highlight, 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 Outer Display is a horizontal panel visible whether the Cover is in place or removed. It provides
information on operational parameters as well as additional information about the perfusion history.
The display can be toggled between numerical values and trend lines of values for ow 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 within the Bubble Trap as read by a sensor.
30/18
PRESSURE
mmHg
120
FLOW
ml/min
0.18
RESISTANCE
mmHg/ml/min
2.3°C
TEMPERATURE
Ice
5.0°C
Trap
MESSAGE DISPLAY PANEL
shows Operation Mode, Infusion
Time, Battery Life, organ information,
and if applicable, error messages
TEMPERATURE
two readings measured at two different sensors;
displayed in degrees Celsius
PRESSURE
Systolic and diastolic
pressure within the kidney
FLOW RATE
of perfusate
through the kidney
(VASCULAR) RESISTANCE
within the kidney
PLOT / CLEAR BUTTON
toggles between display modes
and clears error messages
ID: ABC123
Kidney - Right
Blood - O+
TPG_1

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
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Pump Deck
On the Pump Deck, LifePort Kidney Transporter Disposable Perfusion Circuit tubing traverses a
peristaltic pump, valves and sensors, which control the pressure, speed, and uid pathway of the perfusate.
Bubble Detectors
Infusion Pump
Wash Valve
Infuse Valve
Pumphead Raceway
Spring Arm and Latch
Pump Deck Locking Arm
Pressure Sensor Cable
Tubeframe Sensor
• Pump Deck Locking Arm—secures the Perfusion Circuit Tubeframe in place on LifePort Kidney
Transporter.
• Tubeframe Sensor—detects when the LifePort Kidney Transporter Disposable Perfusion Circuit
Tubeframe is properly placed.
• Infuse and Wash Valves—determine whether the perfusate enters or bypasses the kidney. In Infuse
and Prime Modes, the Infuse Valve is open and the Wash Valve is closed, allowing perfusate to ow
into the kidney. In Wash Mode and while purging bubbles, the Wash Valve is open and the Infuse Valve
is closed, directing the perfusate through the Wash Line, directly back into the perfusate reservoir.
• Pressure Sensor Cable—provides LifePort Kidney Transporter with information 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 perfusate to prevent bubbles from entering the kidney. One is located
upstream of the Perfusion Circuit Bubble Trap to divert detected bubbles away from the kidney and
into the Wash Line, after which LifePort Kidney Transporter will resume perfusing. The other is located
immediately before the Infuse Valve and prevents detected bubbles from entering the kidney by
stopping perfusion altogether.
• Infusion Pump—a peristaltic pump that propels perfusate through the kidney. It circulates perfusate
through the kidney by moving rollers against the Perfusion Circuit Pump Tubing Loop. LifePort Kidney
Transporter regulates pump speed to control perfusion pressure.
WARNING: Beware of rotating parts. Keep hands, clothing, jewelry, ID lanyards, etc. away from
the vicinity of the Infusion Pump when LifePort Kidney Transporter is powered on.
• Pumphead Raceway—consists of a spring arm and latch which hold the Perfusion Circuit Pump
Tubing Loop in place around the Infusion Pump.
Cover
An insulated, removable, latched Cover securely closes over the housing to protect the kidney and maintain
the proper temperature during perfusion.