LifePort Kidney Transporter Operator’s Manual

LifePort Kidney Transporter 1.1

Operator’s Manual

This Operator’s Manual references

EC

REP

LifePort Kidney Transporter

Model Numbers:

LKT101P

LKT101PNG

2460

For technical assistance, please call Organ

Recovery Systems 24/7 Perfusion Helpline at one

of the numbers listed below.

Organ Recovery Systems Organ Recovery Systems NV ORS Representacoes do Brasil Ltda.
One Pierce Place, Ste 475W DaVincilaan 2, Box 6 170 Moema Avenue, 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 +55.11.98638.0086
F +1.847.824.0234 F +32.2.715.0009

Perfusion Helpline: Perfusion Helpline: Perfusion Helpline:

+1.866.682.4800 +32.2.715.0005 +55.11.98638.0086
+33.9.6723.0016
+34.910.91.16.16

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

EC

REP

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

LifePort Kidney Transporter manufactured in the USA for Organ Recovery Systems, Inc.

© 2020 Organ Recovery Systems, Inc.

Made and printed in the USA.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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Table of Contents

Introduction

Purpose of Manual ............................................................................................................................................. 1

Abbreviations ...................................................................................................................................................... 1

Label Graphics Explanations .............................................................................................................................. 2

System Description

Intended 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

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual ii

Enter Device Information ...................................................................................................................................13

External Communications using Data Station ...................................................................................................13

GPS/GPRS Tracking Capability (If Applicable)..................................................................................................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

LifePort Kidney Transporter Disposable Universal SealRing ........................................................................18

LifePort Kidney Transporter Disposable SealRing Cannula..........................................................................18

LifePort Kidney Transporter Disposable Straight Cannula ............................................................................19

LifePort Kidney Transporter Disposable Coupler ..........................................................................................19

Place the Kidney................................................................................................................................................20

Place the Kidney in Kidney Cradle ................................................................................................................20

Place the Kidney Cradle in LifePort Kidney Transporter ...............................................................................20

Prime and Initiate Perfusion ..............................................................................................................................21

Check Kidney Parameters .................................................................................................................................21

Data Station Monitoring .................................................................................................................................22

GPS/GPRS Tracking (If Applicable) .............................................................................................................. 22

Kidney Behavior on LifePort Kidney Transporter ..........................................................................................23

Leaks at the Cannula or Open Side Branch ............................................................................................23

Nonresponsive Kidney ............................................................................................................................23

Remote Monitoring ........................................................................................................................................23

Traveling with LifePort Kidney Transporter ........................................................................................................24

Rell Ice / Swap Batteries..................................................................................................................................24

Add More Ice .................................................................................................................................................24

Replace Batteries ..........................................................................................................................................24

Remove Kidney From LifePort Kidney Transporter ...........................................................................................25

Clean Up After A Case ....................................................................................................................................... 25

Data Capture and Download (Optional) ............................................................................................................26

Using A Computer .........................................................................................................................................26

Using A Flash Drive .......................................................................................................................................26

Troubleshooting and Diagnostics

Troubleshooting Procedures .............................................................................................................................27

Error Message Explanations .............................................................................................................................28

Power On Self Test (POST) ...............................................................................................................................30

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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Maintenance

Overview........................................................................................................................................................... 31

Storage ............................................................................................................................................................. 31

Repairs ............................................................................................................................................................. 31

Specications, Precautions, Limitations

Product Specications ...................................................................................................................................... 32

Device Classications....................................................................................................................................... 32

Electromagnetic Compatibility .......................................................................................................................... 33

Operational Precautions and Limitations .......................................................................................................... 36

Hazards

Overview........................................................................................................................................................... 38

Index ���������������������������������������������������������������������������������������������������������������������������� 39

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual iv

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 art or science of organ perfusion. 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 (see inside front cover for contact details).

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 Ampule

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

GPRS General Packet Radio Services

GPS Global Positioning System

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

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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Label Graphics Explanations

STERILEEOEO

REF

REF

S

N

STERILIZE

STERILEAA

The following table provides an explanation of the label graphics found on LifePort Kidney Transporter.

S

STERILE

N

Warning/Caution Do Not Reuse

2

Lot Number Do Not Resterilize

Serial Number Temperature limits

Reference Number Sterilized Using Aseptic Fill

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

Power button/standby power Circuit breaker. Push to reset.

STERILIZE

5

STERILE

IPX1

Protected against falling water.

Data Port (USB)

1

2

3

Battery slot graphic showing slot numbering
and insertion orientation.

Medical Device

Interference may occur in the vicinity of

equipment.

Medical – General medical equipment as to
electrical shock, re and mechanical hazards

in accordance with ANSI/AAMI ES60601-1.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 2

System Description

Intended Use

LifePort Kidney Transporter (LKT) is intended for use in continuous hypothermic machine perfusion of kidneys.

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 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 fail-safe 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.

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.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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LifePort Kidney Transporter

Disposable Perfusion Circuit

Pump Deck

Ice Container

Insulating Cover

Control Panel

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.

RAISE AND LOWER

infusion pressure (by

1-mmHg increments)

POWER

Off / On

PRESSURE SETPOINT

(default 30 mmHg)

SELECT MODE

SET

Wash

Prime

30

mmHg

Infuse

(Wash, Prime,

Infuse)

(highlight, select, and enter information)

Organ ID: ABC123

Kidney:
Blood Type:
Clamp Date:
Clamp Time:
Clamp TMZ:

5-WAY KEYPAD

DATA ENTRY /

DISPLAY screen

N/A
N/A

00-00-0

00:00

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 as read by a sensor within the Bubble Trap.

PRESSURE

Systolic and diastolic

pressure within the kidney

(VASCULAR) RESISTANCE

within the kidney

MESSAGE DISPLAY PANEL

shows Operation Mode, Infusion

Time, Battery Life, organ information,

and if applicable, error messages

PRESSURE

30/18

mmHg

PLOT / CLEAR BUTTON

toggles between display modes

and clears error messages

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 4

FLOW

120

ml/min

FLOW RATE

of perfusate

through the kidney

RESISTANCE

0.18

mmHg/ml/min

two readings measured at two different sensors;

TEMPERATURE

5.0°C

2.3°C

Ice

Trap

TEMPERATURE

displayed in degrees Celsius

ID: ABC123
Kidney - Right
Blood - O+
TPG_1

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.

Pump Deck Locking Arm

Bubble Detectors

Wash Valve

Infuse Valve

Infusion Pump

Pressure Sensor Cable

Pumphead Raceway

Spring Arm and Latch

• Pump Deck Locking Arm – Secures the Perfusion Circuit Tubeframe in place on LifePort Kidney
Transporter.

• Infuse and Wash Valves – Determine whether the perfusate enters or bypasses the kidney. In
INFUSE and PRIME mode, 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 bypass 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 – Two non-contact 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.

• 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.

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External Connections Panel

LifePort Kidney Transporter connects with an
external power source and other devices through
the External Connections Panel, which provides a
standard AC Power Cord connector and USB-A and
USB-B Data Ports.

Data Ports

Circuit Breakers

AC Power Cord

connector

Two Circuit Breakers trip if a short circuit occurs.
Depressing the button resets the breaker.

CAUTION: Use only cables and accessories approved by Organ Recovery Systems. Non-approved
cables and accessories may damage the system or interfere with accuracy. For information, contact the
Organ Recovery Systems 24/7 Perfusion Helpline.

Battery Door

Operational Accessories

It is important to use only the accessories supplied by Organ Recovery Systems, as listed below.

Power Cord

LifePort Kidney Transporter comes equipped with a hospital grade Power Cord that connects to the LifePort
Kidney Transporter 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 the Power Cord supplied from Organ Recovery
Systems. For information, contact the Organ Recovery Systems 24/7 Perfusion Helpline.

Data Cable

The 6-ft (2m) Data Cable connects LifePort Kidney Transporter to an external computer. The USB-A
end connects to the Data Port on the LifePort and the USB-B end connects to the USB port of a
personal computer.

Batteries

LifePort Kidney Transporter uses four specially designed lithium-ion rechargeable batteries as its portable
source of power.

CAUTION: Do not substitute batteries. Use only LifePort Kidney Transporter batteries from Organ
Recovery Systems. For information, contact the Organ Recovery Systems 24/7 Perfusion Helpline.

When powered on, LifePort Kidney Transporter draws power from one battery at a time, using the batteries in
series. It is possible to operate LifePort Kidney Transporter with one to four batteries, as each battery delivers the

11 to 12 volts required. However, it is recommended to use all four batteries, keeping the batteries as fully charged

as possible.

NOTE: Total battery life can be found under the Device Information tab on the Message Display Panel.

Access the batteries through the Battery Door on the LifePort Kidney Transporter back panel. Each battery is

designed to slide in and out of the slots provided. When inserted properly, the battery should be ush with the
slot panel, with the pull-tab visible and available for removing the battery. If the battery does not push ush, it

may be in the wrong orientation. Turn the battery 180 degrees and try again.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 6

The following tips will help you obtain maximum life and serviceability from the batteries.

• Always replace the Battery Door. LifePort Kidney Transporter should not be operated or shipped
without the Battery Door in place.

• LifePort Kidney Transporter will replenish the batteries whenever it is plugged into an external power
supply. Plug in LifePort Kidney Transporter whenever not in transit to keep the batteries at the highest
possible charge. It takes approximately ve (5) hours to completely recharge all four (4) batteries.

NOTE: Keep extra charged batteries on hand when long transport times are anticipated or when
successive uses of LifePort Kidney Transporter with short turnaround times are expected.

• During storage of LifePort Kidney Transporter without connection to an external power supply, the
batteries will slowly drain. After 30 days without charging, the batteries could have little or no charge
and will need a full ve-hour recharge.

• For periods of storage for longer than 30 days, remove the batteries from LifePort Kidney Transporter.

NOTE: Long periods of storage may damage the batteries. Lithium-ion batteries must be disposed of
according to local regulations. If in doubt, call the Organ Recovery Systems 24/7 Perfusion Helpline.

Safe Disposal of LifePort Kidney Transporter and LifePort Batteries

For safe disposal of LifePort Kidney Transporter or LifePort Kidney Transporter batteries, call the Organ
Recovery Systems 24/7 Perfusion Helpline to arrange for pickup from your facility.

LifePort Kidney Transporter Disposable Products

Single-use Disposables, an integral part of the LifePort Kidney Transporter system, are used to maintain the
kidney and perfusate under aseptic conditions, to connect the kidney to the Perfusion Circuit, and to help
maintain aseptic conditions while working inside the Perfusion Circuit. Each LifePort Kidney Transporter
Disposable is factory sterilized and delivered in a sterile pack.

WARNING: For single use only. Do not reuse, reprocess, or resterilize. Reusing, reprocessing,
or resterilization of single-use devices creates a potential risk of patient or user infections due to
contamination. This contamination may lead to injury, illness, or other serious patient complications.
Discard any unused portion of the product.

NOTE: To reorder LifePort Kidney Transporter Disposables, please contact Organ Recovery Systems.

LifePort Kidney Transporter Disposable Cannulas

LifePort Kidney Transporter Disposable cannulas attach LifePort Kidney Transporter Disposable Perfusion
Circuit to the kidney’s renal artery. A large range of cannula types and sizes are available, making it possible to
choose the cannula most compatible to the anatomy of the kidney.

LifePort Kidney Transporter Disposable Sterile Drape

The LifePort Kidney Transporter Disposable Sterile Drape is used to aid in maintaining aseptic conditions while
working within the LifePort Kidney Transporter Disposable Perfusion Circuit.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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LifePort Kidney Transporter Disposable Perfusion Circuit

Tubing Circuit (Infuse, Wash,

and Return Lines)

Cannula Mount

Kidney Cradle

Mesh Organ Restraint

Pressure Sensor Connector

Pump Tubing Loop

Organ Cassette

Tubeframe

Filter

Compliance Chamber

Low Fluid Detection
Chamber

Inner and Outer Lids

Bubble Trap

LifePort Kidney Transporter Disposable Perfusion Circuit contains the uid management components

necessary for perfusing a single kidney and is comprised of following:

• Organ Cassette – The housing that contains the kidney and acts as the perfusate reservoir, where the
kidney is maintained partially submerged.

• Low Fluid Detection Chamber – Provides real-time recognition of low uid levels and an

automatic stop of active perfusion if perfusate volume drops below a certain level.

• Inner and Outer Lids – A transparent, sterile Inner Lid 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 the Kidney Cradle that holds the cannula in place.

• Tubeframe – Plastic frame that positions the tubing around the Infusion Pump, valves, and sensors of
the Pump Deck.

• Tubing Circuit – The sealed uid pathway that draws perfusate from the Organ Cassette for

circulation into the kidney, is comprised of the following:

• Bubble Trap – Helps prevent air from entering the Infuse Line.

• Infuse, Wash and Return Lines – Manage perfusate ow.

• Pump Tubing Loop – Extends from the Tubeframe and stretches around the Infusion Pump.

• Compliance Chamber – Helps maintain steady perfusion pressures.

• Filter – Collects material that could block kidney vasculature from achieving proper ows.

• Pressure Sensor Connector – A ow-through Pressure Sensor within the Infuse Line that

measures perfusate pressure within the Perfusion Circuit. Connects to the Pump Deck Pressure
Sensor Cable and sends pressure data to LifePort Kidney Transporter.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 8

Unpack, Setup, and Run Preliminary Tests

Overview

This section provides information for receiving, unpacking, setup and preliminary testing of LifePort Kidney
Transporter. Refer to LifePort Kidney Transporter Use for routine operating instructions.

Introduction

LifePort Kidney Transporter is shipped in a special container that is marked for appropriate handling. It should be

opened and checked only by a person trained and qualied to work with electronic medical equipment.

Select a Home Base Station

Designate a home base station for each LifePort Kidney Transporter where it can be set up and recharged
between cases. The home base station should be a secure area, provide a clean benchtop or tabletop space,

and meet the following requirements:

• Climate-controlled area of approximately 21°C, 50% humidity.

• No direct sunlight.

• AC electrical outlets (2 to 4 plugs: 120V/15A in the USA).

• Storage for LifePort Kidney Transporter Disposables, batteries, tools and spares.

• Access to crushed or pelletized ice (hollow cubes not recommended).

• Access to a utility sink for cleanup and to provide water for the ice bath.

• Access to medical waste disposal.

• Access to refrigerated storage for 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 rooms and ready access to car, ambulance or helicopter loading areas.

Unpack and Inspect

Carefully remove LifePort Kidney Transporter and its accessories from the shipping container. Save the
packing materials for shipping and storage.

After unpacking, thoroughly inspect the system and all accessories for damage to ensure that:

• LifePort Kidney Transporter housing is not bent or distorted.

• There are no dents, chips or cracks in the housing surface.

• Manual controls and movable parts, such as connectors, operate properly.

• Control Panel and Outer Display are properly aligned.

• All items listed on the shipping documents are present.

Report any damage found from this inspection to the carrier immediately. If you have any concerns
about the condition of LifePort Kidney Transporter or its accessories, contact the Organ Recovery Systems
24/7 Perfusion Helpline.

Run Preliminary Tests

Upon receipt of a new LifePort Kidney Transporter and prior to clinical use, it is recommended that the user
complete the following tests. After each step, ensure LifePort Kidney Transporter functions as described and

that there are no malfunctions, leaks or irresolvable errors. If di󰀩culties arise during setup and testing, refer to

Troubleshooting and Diagnostics.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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Set Up LifePort Kidney Transporter

CAUTION: LifePort Kidney Transporter weighs 45 lbs (20.4 kg) fully loaded. Use proper lifting
procedures to avoid injury.

1. Place LifePort Kidney Transporter so that the Outer Display is easily accessible.

2. Unlatch and remove LifePort Kidney Transporter Cover and store it nearby.

3. Complete your review of LifePort Kidney Transporter, ensuring it is secure, intact, and that nothing
appears damaged, before starting the preliminary tests.

Fill the Ice Container

CAUTION: To avoid inadvertently freezing the kidney, USE ONLY ICE AND COLD WATER in LifePort
Kidney Transporter Ice Container. A mixture of ice and cold water in the Ice Container will ensure that
temperatures remain within the appropriate range for clinical kidney preservation.

NOTE: As a safeguard to the kidney, LifePort Kidney Transporter will not operate unless the Ice Container
temperature is chilled below 8°C. After installation of the Ice Container, it may take several minutes before
the display reads a temperature below 8°C.

1. Open the Ice Container and ll with crushed or pelletized ice, pushing the ice as far in as possible.

2. Pour approximately 1 Liter of cold water (less than 10°C) into the Ice Container, which will gradually
loosen the ice.

3. Add more ice and another 0.5-1.0 Liter of cold water until the Ice Container is full, maximizing the
amount of ice added.

4. Replace and lock the Ice Container Lid.

Load LifePort Kidney Transporter Disposable Perfusion Circuit

NOTE: As this is a preliminary 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 Arms and Pumphead Raceway are open on LifePort Kidney Transporter.

2. Unpack LifePort Kidney Transporter Disposable Perfusion Circuit and place into the Ice Container.

3. Position the Tubeframe upright, perpendicular to the Pump Deck. Insert the hinges into the receivers
before rotating the Tubeframe at onto the Pump Deck.

4. Stretch the Pump Tubing Loop around the Infusion Pump. Close and latch the Pumphead Raceway.

5. Rotate the Pump Deck Locking Arm 90 degrees until it clicks into place.

6. Connect the Pressure Sensor Cable from the Pump Deck to the Pressure Sensor Connector on the
Tubeframe.

7. Remove the Inner and Outer Perfusion Circuit Lids and pour 1 Liter of cold (less than 10°C) saline into
the LifePort Kidney Transporter Disposable Perfusion Circuit.

8. Replace and secure the Inner and Outer Perfusion Circuit Lids.

Energize the LifePort Kidney Transporter

1. Connect the Power Cord to LifePort Kidney Transporter External Connections Panel and plug it into an
external power supply.

2. Press and hold the POWER button until you hear an audible beep, then release.

3. On the Control Panel, you should observe the following:

• The screens illuminate.

• The pressure setpoint shows default value of 30 mmHg.

• Mode control displays show WASH, PRIME, and INFUSE.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 10

4. On the Outer Display panel, you should observe the following:

• The screens illuminate.

• Pressure, Flow, and Resistance all read zero.

• Temperature shows the temperature of the Ice Container.

NOTE: The temperature reading may be high when rst energized. When the Ice Container temperature
is above 8°C, LifePort Kidney Transporter will not function and indicate an error message. It may take
several minutes before the display reads below 8°C and the device is operational.

If errors occur during setup or while energizing, refer to Troubleshooting and Diagnostics for information on
how to proceed.

Test Operating Modes

Set Pressure

1. Press the pressure UP/DOWN arrow buttons and verify that the pressure can be adjusted by 1 mmHg
with each press.

2. Using the UP/DOWN arrow buttons, set the pressure to 40 mmHg.

Wash

1. Press the WASH button and verify Infusion Pump rotation.

2. Verify that saline is drawn through the Tubing Circuit, down into the lter, into the Bubble Trap, and
through the Wash Line. Visually verify that the saline is contained in the tubing, without leaking, and is
not owing through the Infuse Line.

3. Press the STOP button to exit Wash Mode.

Prime

1. Press the PRIME button and observe that the ow diverts into the Infuse Line.

2. Verify saline is contained within the tubing, without leaking, and is not owing through the Wash Line.

3. Remove the Outer and Inner Perfusion Circuit Lids.

4. Squeeze or clamp the Infuse Line. LifePort Kidney Transporter will cease function, provide an audible
alert, and the Message Display Panel should read: High Pressure.

5. Release the Infuse Line and press the STOP button to clear the error message.

Infuse

NOTE: You must make an entry under ORGAN ID, KIDNEY and BLOOD TYPE before you can run an
Infuse test.

1. On the 5-way keypad, press OK, use the arrow buttons to select ORGAN INFORMATION, and press
OK again.

2. Select ORGAN ID, then press OK.

3. Select the alphanumerics for the Organ ID you wish to assign, pressing OK with each selection.

4. Scroll to DONE, press OK, and select SAVE to conrm.

5. Select KIDNEY, then press OK.

6. Select NA, press OK, and select SAVE to conrm.

7. Select BLOOD TYPE, then press OK.

8. Select NA, press OK, and select SAVE to conrm.

NOTE: Attach a ow restrictor, a 20-gauge or smaller syringe needle will also work, onto the Luer tting on

the Infuse Line.

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11

9. Press the INFUSE button.

10. Verify that pressure, ow, resistance, and temperature readings are displayed on the Outer Display.

NOTE: TRAP temperature represents the temperature measured at the Bubble Trap, which is only
displayed during active infusion.

11. Verify that the ORGAN INFORMATION you entered is displayed.

12. Press the STOP button to exit Infuse Mode.

13. Press and hold the POWER button to turn o󰀨 LifePort Kidney Transporter.

Test Batteries

Upon receipt of a new LifePort Kidney Transporter and prior to clinical use, it is recommended that the user
complete the Preliminary Tests with and without the batteries. Allow the batteries to charge in LifePort Kidney

Transporter for at least ve hours prior to clinical use.

1. Open LifePort Kidney Transporter Battery Door by sliding it away from the product label.

2. Insert the batteries.

3. Replace the LifePort Kidney Transporter Battery Door.

NOTE: LifePort Kidney Transporter Battery Door should be in place whenever LifePort Kidney Transporter is
operated or transported.

4. Verify the Outer Display shows that LifePort Kidney Transporter is plugged in and charging. Allow the
batteries to charge in LifePort Kidney Transporter for at least ve hours before unplugging the Power
Cord.

5. Repeat the ENERGIZE and TEST OPERATING MODES tests as described above, using battery power.

NOTE: Ensure that the Power Cord is unplugged before repeating the tests to accurately assess battery
power.

Check Duration of Operation (Optional)

1. Press OK.

2. Select DEVICE INFORMATION, then press OK.

3. View percentage of battery charge. The screen returns to the main screen in 10 seconds.

4. With the batteries fully charged and the Ice Container full, operate LifePort Kidney Transporter in Infuse
Mode for 24 hours. During this test:

• Keep the Flow Restrictor positioned on the Infuse Line.

• Keep the Cover closed for the entire 24 hours.

5. Verify that the ice and batteries last throughout the entire duration of the test.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 12

Enter Device Information

1. Press OK, use the arrow buttons to select DEVICE INFORMATION.

2. Select DEVICE ID, then press OK.

3. Select the alphanumerics for the name you wish to assign LifePort Kidney Transporter, pressing OK with
each selection.

4. Scroll to DONE, press OK, and select SAVE.

5. Select DATE to enter the current month, day, and year and press OK. Select SAVE to conrm.

6. Select TIME to enter the current time and press OK. Select SAVE to conrm.

7. Select TIME ZONE (TMZ) to enter the alphanumerics of the time zone you wish to assign, pressing OK
with each selection.

NOTE: The time zone must be in 3 characters, e.g., “CST” for “Central Standard Time”.

8. Scroll to DONE, press OK, and select SAVE.

9. Select LANGUAGE and scroll to the desired language you want LifePort Kidney Transporter to display.

10. Scroll to DONE, press OK, and select SAVE.

External Communications using Data Station

Data Station software allows communication between LifePort Kidney Transporter and a computer, making it
possible to monitor LifePort Kidney Transporter operations.

Consult the Data Station User Guide to install the application on the computer(s) you plan to use to monitor
LifePort Kidney Transporter.

GPS/GPRS Tracking Capability (If Applicable)

LifePort Kidney Transporter model LKT101P contains a built in GPS/GPRS that will interact with an online
website portal. Using the LifePort Kidney Transporter Portal, users can:

• Locate, track, and view an entire history of travel for LifePort Kidney Transporter.

• Read information from LifePort Kidney Transporter such as renal resistance and temperature, allowing
customers to vigilantly monitor the kidney as it travels to its destination.

Access to the customized portal will be setup prior to initial use by the customer for convenience. The web
address for the LifePort Kidney Transporter GPS/GPRS Portal is https://lifeport.blacklinegps.com.

LifePort Kidney Transporter model LKT101PNG does not have this capability.

Clean Up and Review after Use

1. If LifePort Kidney Transporter is still running, press the STOP button.

2. Press and hold the POWER button.

3. Remove LifePort Kidney Transporter Disposable Perfusion Circuit and properly dispose of it.

4. Remove the Ice Container and empty its contents.

5. Dry and place the Ice Container back into LifePort Kidney Transporter. Leave the Ice Container Lid ajar.

6. Wipe down LifePort Kidney Transporter with a 70% isopropanol solution.

7. Replace LifePort Kidney Transporter Cover and properly store for future use.

Problems uncovered during any of these tests should be investigated and resolved. Be aware to look for leaks,

misrouted ow, and extra or missing error messages.

LifePort Kidney Transporter should always stay dry and error-free. Anomalies uncovered during any of these

tests such as leaks, misrouted ow, and extra or missing error messages should be investigated and resolved.

If you need assistance, contact the Organ Recovery Systems 24/7 Perfusion Helpline.

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LifePort Kidney Transporter Use

Introduction

This section provides information on routine use of LifePort Kidney Transporter from setup through cleanup
during a clinical case.

NOTE: Be sure to keep the batteries plugged in and charging when LifePort Kidney Transporter is not in use.

Professional Overview

Before using LifePort Kidney Transporter in a clinical setting, thoroughly familiarize yourself with the device and
kidney perfusion. Consider practicing on discarded or animal kidneys. Various settings should be tried and a

sense obtained as to the e󰀨ects on the kidney.

Be aware of the following important factors:

• Select an infusion pressure for use according to good clinical practice to assure su󰀩cient ow while
preventing vascular damage.

• Secure cannulas to avoid perfusate leaks while preventing damage to the transplanted artery.

• Inspect and position the cannulated artery to avoid any twists or kinks that would occlude the ow of
perfusate.

• Maintain aseptic conditions for the kidney and perfusate at all times. Sealing the Organ Cassette while

using standard aseptic technique is required.

• Maintain hypothermic conditions for the kidney by keeping LifePort Kidney Transporter Ice Container

lled. Use only ice and water to prevent freezing.

Maintain LifePort Kidney Transporter 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 Base Station

LifePort Kidney Transporter and its supplies and accessories are designed to be an integral part of the
recovery team’s supply pack, to be seamlessly included in the recovery and transplant process.

Have the following prepared to keep LifePort Kidney Transporter in a ready-to-use state:

• Crushed or pelletized ice—10 lbs (5-6 kg) or more—readily available in a freezer or ice maker.

• Batteries loaded in LifePort Kidney Transporter and kept fully charged. Maintain the batteries’ charge by
keeping LifePort Kidney Transporter plugged into an external power supply.

• Perfusion Circuit, Sterile Drapes, and cannulas packed and ready.

• Portable wheeled cart available and ready.

• Surgical instruments, suture, solution decanter, and supplies packed and ready.

• Spare parts at hand, such as additional charged batteries, Power Cord, spare cannula, etc.

• Distilled, sterile, or regular tap water (about 5 Liters)—chilled in the refrigerator.

• Perfusion solution and organ ush solution—chilled in the refrigerator.

CAUTION: Use only machine perfusion solution in LifePort Kidney Transporter. Check the
labeling of the perfusion solution and make sure that it is intended for machine perfusion.

NOTE: If you are uncertain about which solutions are appropriate, contact the Organ Recovery Systems
24/7 Perfusion Helpline for information on recommended perfusates that work best in LifePort Kidney
Transporter.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 14

Prepare LifePort Kidney Transporter for Recovery

These instructions can be modied according to your institution’s procedures. When you receive the call that

LifePort Kidney Transporter is needed, perform the following procedures to prepare the device before taking it
to recover a kidney:

• Make sure you have everything you need – using a checklist, double check all your equipment and
supplies to make sure it is all packed and on the cart.

• Recheck the batteries – check that the batteries are fully charged. Press the POWER button and verify
that the LifePort Kidney Transporter powers up. Press the POWER button again to turn it o󰀨.

• Visually check LifePort Kidney Transporter and Disposable Perfusion Circuit – check for overall
integrity and transport-worthiness before each use. Do not use if parts are loose, cracked, broken, or

liquid is leaking.

Travel with LifePort Kidney Transporter and Supplies

If you’re traveling in a vehicle with LifePort Kidney Transporter, take the following precautions:

• Push the cart with LifePort Kidney Transporter and supplies to the vehicle and place the LifePort Kidney
Transporter on the seat or in the trunk.

• Secure LifePort Kidney Transporter from sliding or rolling. If the device is placed on a vehicle seat, the
normal seat belt can be used to restrain 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;
however, it should be kept in an upright orientation to minimize the potential for leaks, spills, or air bubbles.

At a remote recovery site, LifePort Kidney Transporter and supply packs can be reloaded onto the cart, which
can be pushed to the donor operating room.

Fill LifePort Kidney Transporter Ice Container

CAUTION: To avoid inadvertently freezing the kidney, USE ONLY ICE AND WATER in LifePort Kidney

Transporter Ice Container. A mixture of ice and water in the Ice Container will ensure that temperatures
remain within the appropriate range for kidney preservation.

NOTE: As a safeguard to the kidney, LifePort Kidney Transporter will not operate unless the Ice Container
temperature is chilled below 8°C. After installation of the Ice Container, it may take several minutes before the
display reads a temperature below 8°C.

1. Remove the Cover from LifePort Kidney Transporter and remove the Ice Container.

2. Open the Ice Container and ll it with crushed or pelletized ice, pushing the ice as far in as possible.

3. Pour approximately 1 Liter of cold water (less than 10°C) into the Ice Container, which will gradually
loosen the ice.

4. Add more ice and another 0.5-1.0 Liter of water until the Ice Container is full, maximizing the amount of ice
added.

5. Replace and lock the Ice Container Lid.

6. Place locked Ice Container in LifePort Kidney Transporter.

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Load LifePort Kidney Transporter Disposable Perfusion Circuit

Once you have veried the kidney and checked for any contraindications against proceeding, use these

instructions to load the LifePort Kidney Transporter Disposable Perfusion Circuit into LifePort Kidney
Transporter.

NOTE: This procedure can also be found in the LifePort Kidney Transporter Disposable Perfusion
Circuit Instructions For Use.

CAUTION: Where noted, perform the following procedure on an aseptic eld using standard aseptic
technique.

1. Using standard aseptic technique, prepare a sterile eld and introduce all necessary materials.

2. Using standard aseptic technique, remove Outer Perfusion Circuit Lid and Inner Perfusion Circuit Lid and

place onto the sterile eld.

3. Using standard aseptic technique, remove the Kidney Cradle and set aside within the sterile eld.

4. Using standard aseptic technique, ll LifePort Kidney Transporter Disposable Perfusion Circuit with 1 Liter
chilled (2-8°C) perfusate.

5. Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid followed by the Outer
Perfusion Circuit Lid.

CAUTION: LifePort Kidney Transporter Disposable Perfusion Circuit inner surfaces are considered
sterile, while outer surfaces are not considered sterile.

6. Place Perfusion Circuit into LifePort Kidney Transporter.

7. Position the Tubeframe upright, perpendicular to the Pump Deck. Insert the hinges into the receivers
before rotating at onto the Pump Deck.

8. Open the Pumphead Raceway and stretch the Pump Tubing Loop around the Infusion Pump. Close and
latch the Pumphead Raceway.

9. Rotate the Pump Deck Locking Arm 90 degrees until it clicks into place.

10. Connect the Pressure Sensor Cable from the Pump Deck to the Pressure Sensor Connector on the
Tubeframe.

11. Press and hold the POWER button until you hear an audible beep, then release.

12. Press the WASH button to enter WASH mode.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 16

Enter ORGAN ID Information

The ability to enter the ORGAN ID, BLOOD TYPE, KIDNEY TYPE, and CROSS CLAMP TIME are optional and
for your convenience. The information is locked once perfusion begins, and can only be edited within the Data
Station upon completion of the perfusion case. Each perfusion le will be identied by ORGAN ID.

If kidney information is not entered:

• ORGAN ID will default to the time stamp when Infuse Mode begins. The timestamp format is
MMDDYYHHMMSS.

• KIDNEY TYPE will default to NA.

• BLOOD TYPE will default to NA.

To enter kidney values, perform the following steps:

1. Press OK, use the arrow buttons to select ORGAN INFORMATION, and press OK again.

2. Select ORGAN ID and press OK.

3. Select the alphanumerics for the ORGAN ID you wish to assign, pressing OK with each selection.

4. Scroll to DONE, press OK, and select SAVE to conrm.

5. Select KIDNEY and press OK.

6. Select LEFT or RIGHT, as appropriate, press OK, and select SAVE to conrm.

7. Select BLOOD TYPE and press OK.

8. Select the A, B, AB, or O, as appropriate, press OK, and select SAVE to conrm.

9. Select CLAMP for cross clamp time and press OK.

10. Enter the correct cross clamp time, press OK, and select SAVE to conrm.

Isolate the Kidney Vascular Structure

Use the procedures specied by your institution for isolating the kidney vascular structure. The following

diagrams depict typical kidney anatomy. Kidneys with atypical anatomy can also be cannulated using LifePort
Kidney Transporter Disposable Cannulas.

Right adrenal gland

Aorta

Right renal artery

Right kidney

Right renal vein

Inferior vena cava

Right ureter

Right adrenal gland

Aorta

Right renal artery

Left adrenal gland

Left renal artery

Left kidney

Left renal vein

Left ureter

Left adrenal gland

Left renal artery

Left kidney

Right kidney

Right renal vein

Right ureter

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17

Inferior vena cava

Left ureter

Left renal vein

Cannulate the Kidney

LifePort Kidney Transporter Disposable Universal SealRing

INDICATIONS FOR USE: The Universal SealRing is used when the vessel to be perfused ends with or without
an aortic patch or similar condition.

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Introduce Universal SealRing onto the sterile eld.

NOTE: Choose the appropriate size cannula based on the diameter of the renal artery lumen.

2. Open Universal SealRing by unhooking the straps, unsnapping, and opening the right anvil.

3. Position the vessel in the center of the anvils so the terminated end of the vessel is approximately 1.5-

2.0mm above the top surface of the anvils.

4. Close the right anvil capturing the vessel with an audible click.

NOTE: If necessary, retention stays can be added to the vessel using suture or other appropriate material.
Suture Tie Down Cleats and slots have been provided to facilitate positioning.

5. Lower the upper portion of Universal SealRing while carefully bringing the conical seal into the interior of
the vessel.

NOTE: Viewing through the magnied sight-glass, verify that the vessel orice is centered, circular in

shape, and not occluded.

6. Wrap each strap around both cannula halves and secure the straps to their posts.

LifePort Kidney Transporter Disposable SealRing Cannula

INDICATIONS FOR USE: The SealRing Cannula is used when the vessel to be perfused ends with an aortic
patch or similar condition.

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Introduce SealRing Cannula onto the sterile eld.

NOTE: Choose the appropriate size cannula based on the diameter of the renal artery lumen.

2. Unhook the straps and open the SealRing cannula.

3. Slide the aortic patch through the center of the cannula ring.

4. Lay patch at, making sure that the tissue covers the entire cannula ring. If necessary, instruments may be
used to temporarily hold the tissue in place until SealRing Cannula is secure.

5. Close SealRing Cannula, securing the tissue between the two cannula halves.

6. Wrap each strap around both cannula halves and secure the straps to their posts.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 18

LifePort Kidney Transporter Disposable Straight Cannula

INDICATIONS FOR USE: The Straight Cannula is used when the vessel to be perfused ends without a patch
or when intimal damage to the lining is not a concern.

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Introduce Straight Cannula onto the sterile eld.

NOTE: Choose the appropriate size cannula based on the diameter of the renal artery lumen.

2. Insert the Straight Cannula tip no further than necessary into the vessel. Minimizing the length of
the cannula tip being inserted into the vessel will allow for resection of that segment of the vessel, if
necessary.

3. Secure the vessel in place using silk ties, vessel loops, or another appropriate material. A groove in the tip
is provided for positioning and securing.

LifePort Kidney Transporter Disposable Coupler

INDICATIONS FOR USE: The Coupler is used to connect two or more cannula when multiple vessels must be
perfused.

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Introduce Coupler onto the sterile eld.

2. Connect Universal SealRing, SealRing Cannula, or Straight Cannula to each of the vessels to be
perfused, according to their Indications For Use.

3. Identify a main vessel and snap the cannula connected to it into the Cannula Mount.

NOTE: See Place the Kidney for detailed instructions on using the Cannula Mount and placing the kidney in
the Kidney Cradle.

4. Replace the End Cap on the main vessel cannula with one end of the Coupler.

5. Attach the second end of the Coupler to the port of the next cannula.

6. Use an additional Coupler and repeat steps 4 and 5 for each cannula being used.

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19

Place the Kidney

After cannulation, the kidney must be secured in the Kidney Cradle and placed in LifePort Kidney Transporter
Disposable Perfusion Circuit in LifePort Kidney Transporter.

Place the Kidney in Kidney Cradle

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Place the cannulated kidney in the Kidney Cradle and snap the cannula into the Cannula Mount.

NOTE: If perfusing multiple vessels, connect only the main vessel cannula to the Cannula Mount.

2. Adjust the height of the Cannula Mount and rotation of the cannula to comfortably position the vessel.

3. Visually inspect the vessel, ensuring there are no twists or occlusions.

4. Secure the Mesh Organ Restraint over the kidney in the Kidney Cradle, allowing for slight swelling while
being perfused.

Place the Kidney Cradle in LifePort Kidney Transporter

CAUTION: Where noted, perform the following procedure on an aseptic eld using standard aseptic
technique.

A person outside the sterile eld should perform the following:

• Remove the LifePort Kidney Transporter Cover, if necessary.

• Press the STOP button to halt the wash cycle, if necessary.

• Remove the Outer Perfusion Circuit Lid.

1. Using standard aseptic technique, carefully place LifePort Kidney Transporter Disposable Sterile Drape
onto LifePort Kidney Transporter, lining up the drape gasket and the well of the Outer Perfusion Circuit Lid.

2. Using standard aseptic technique, ensure the arrow on the orientation guide is pointing toward the Pump
Deck.

3. Using standard aseptic technique, unfold Sterile Drape in the following order: right, left, front, and back.

The drape gasket should t securely into the well of the Outer Perfusion Circuit Lid.

4. Using standard aseptic technique, unlatch and remove the Inner Perfusion Circuit Lid. Place the lid

facedown onto the sterile eld.

5. Using standard aseptic technique, transfer the cannulated kidney in the Kidney Cradle to LifePort Kidney
Transporter, being careful to avoid catching the Infuse Line.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 20

Prime and Initiate Perfusion

Once the Kidney Cradle containing the cannulated kidney has been placed into the LifePort Kidney Transporter
Disposable Perfusion Circuit Organ Cassette in LifePort Kidney Transporter, it’s time to prime the Infuse Line to

remove any bubbles from the line and renal artery. Once LifePort Kidney Transporter has nished priming, you

can perfuse the kidney.

NOTE: The following procedure is performed on an aseptic eld using standard aseptic technique.

1. Connect the Infuse Line to the cannula on the Cannula Mount and tighten the Luer lock tting.

2. Remove the End Cap from the cannula to provide a path for bubbles to escape.

3. Through the Sterile Drape, press the PRIME button.

4. Check for bubbles in the perfusate, owing from the disconnected end of the cannula.

5. Replace the End Cap on the cannula. LifePort Kidney Transporter should automatically stop priming,
display a visual “High Pressure” error message, and give an audible alert. If LifePort Kidney Transporter

does NOT stop and there is no audible alert, there may be a leak.

NOTE: Leaks may originate from the cannulation site or arteries, or from the Perfusion Circuit. There are
two types of leaks to look for:

A. Leaks from the cannulation site or artery. Identify and address any leaks.
B. Leaks from the Perfusion Circuit. Press the STOP button and check the Perfusion Circuit. If perfusate

is leaking out of the Perfusion Circuit, call the Organ Recovery Systems 24/7 Perfusion Helpline.
Replace Perfusion Circuit and repeat the priming procedure above. Retain the leaking Perfusion
Circuit for possible return.

6. Through the Sterile Drape, use the UP/DOWN arrows to choose the pumping pressure.

NOTE: The default pressure setting is 30 mmHg.

7. Through the Sterile Drape, press the INFUSE button to start perfusion. This will also begin the recording
of perfusion data and other parameters.

Check Kidney Parameters

LifePort Kidney Transporter Outer Display provides the following comprehensive information on the status of
perfusion:

PRESSURE

30/18

mmHg

FLOW

120

ml/min

RESISTANCE

0.18

mmHg/ml/min

TEMPERATURE

2.3

Ice

°C

5

Trap

Infuse
00h 28m 16s

ID: ABC123
Kidney: Right
Blood: O

• Pressure—these are the actual systolic and diastolic pressures of the perfusion process, as LifePort
Kidney Transporter attempts to achieve the systolic pressure you have set. The systolic value is often
lower, but should never be higher, than the set pressure.

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21

• Flow—the volume of perfusate moving through the kidney over time. Flow changes, depending on how
the kidney is responding to the pumping. This value is expected to increase over time, as the kidney
vasodilates, thus allowing the set pressure to deliver a growing ow rate.

• Resistance—the force required to pump perfusate through the kidney. This value is expected to
decrease, as kidney “loosening” provides less and less resistance to pumping over time. Resistance
and Flow are inversely proportional.

• Temperature—the temperature of the ice bath and/or the perfusate, as measured in the Bubble 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 temperature
reaches 8°C, perfusion will stop and the error message, requiring user intervention, “Too Warm, Add
Ice” will display. The trap value displays the perfusate temperature only during infusion, not while
LifePort Kidney Transporter is stopped.

NOTE: Press the PLOT/CLEAR button on the far left side of the Outer Display to temporarily display

trending data for ow and resistance.

The far right side of the Outer Display is the Message Display which provides a range of ID, error, and
functional information.

• Current Mode of Operation—the upper left corner tells LifePort Kidney Transporter’s current mode of
operation, corresponding to the controls on the top of the unit: INFUSE, STOPPED, PRIME, or WASH.

• Battery vs� AC Power—the icon in the upper right corner shows whether LifePort Kidney Transporter
is operating on AC or battery power.

NOTE: If LifePort Kidney Transporter is connected to a power source but is not operating, the front
panel will display an “electric plug” icon indicating it is charging.

• Organ and Device ID Information—is displayed when no errors are present.

• Errors—are displayed accompanied by an audible alert. In addition, the eld a󰀨ected by the error

ashes its information in yellow or red. For complete information on resolving errors, see Error
Message Explanations.

The number to the left of the battery icon provides infuse time, telling how long LifePort Kidney Transporter has
perfusing. The timer will start as soon as INFUSE has been pressed for the rst time and will continue keeping
track of the time when LifePort Kidney Transporter is in Infuse Mode.

Data Station Monitoring

The Data Station is an optional software application that can be installed on a computer. By connecting
LifePort Kidney Transporter to the Data Station computer, you can monitor all LifePort functions, in real time,
on the Data Station dashboard. The Data Station is capable of monitoring multiple devices.

NOTE: If the Data Station computer is networked or accessible via the Internet, you can access LifePort
Kidney Transporter data from any computer able to connect to it.

GPS/GPRS Tracking (If Applicable)

If you have congured LifePort Kidney Transporter for tracking with its GPS/GPRS capability, you can:

• Locate, track, and view an entire history of travel for LifePort Kidney Transporter.

• Read real-time case information from LifePort Kidney Transporter such as renal resistance and
temperature, allowing customers to monitor the kidney as it travels to its destination.

On any computer connected to the Internet, go to the LifePort Kidney Transporter Portal at:

http://lifeport.blacklinegps.com.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 22

Kidney Behavior on LifePort Kidney Transporter

The graphs below—excerpted from the 2nd page of a Data Station case report—show four parameters of the
typical behavior of a kidney on LifePort Kidney Transporter: Pressure, Flow, Resistance, and Temperature.

It is normal to see ow increase while resistance decreases. This indicates that the kidney is vasodilating.
LifePort Kidney Transporter automatically adjusts the ow rate to achieve the indicated pressure and should
never exceed this setting to avoid barotraumas or specically, endothelial injury.

Pressure (mmHg)

Flow (ml/min)

Resistance (mmHg/ml/min)

Temperature (ºC)

Leaks at the Cannula or Open Side Branch

This graph shows immediate ow but no build-up of resistance. This can indicate a leak at the cannula site
or an open lateral branch of the renal artery.

Flow (ml/min)

Resistance (mmHg/ml/min)

Nonresponsive Kidney

A nonresponsive kidney—not responding to mechanical perfusion—typically shows some degree of ow but
no concurrent decrease in resistance. In this case, it may be appropriate to review available donor, kidney,
procurement, and recipient data before making any decision.

Remote Monitoring

LifePort Kidney Transporter is capable of detecting certain situations during perfusion and providing a physical
and audible alert on such events.

When LifePort Kidney Transporter is connected to a network computer, the Data Station software can be setup
to send these alerts via email or text message to any smartphone.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

23

Traveling with LifePort Kidney Transporter

When traveling with LifePort Kidney Transporter, place the LifePort Kidney Transporter on a vehicle seat or in
the trunk. Secure LifePort Kidney Transporter from sliding or rolling. 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;
however, it should be kept in an upright orientation to minimize the potential for leaks, spills, or air bubbles.
If LifePort Kidney Transporter is transported in a vehicle seat, the standard seatbelt can be used to restrain
LifePort Kidney Transporter while driving.

At a remote recovery site, LifePort Kidney Transporter and supply packs can be reloaded onto the cart, which
can be pushed to the donor operating room.

After the recovery, secure LifePort Kidney Transporter and supplies for travel. Recheck LifePort Kidney
Transporter Cover to make sure it is closed and latched.

Rell Ice / Swap Batteries

LifePort Kidney Transporter 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
Kidney Transporter.

NOTE: LifePort Kidney Transporter will alert when the batteries have two hours remaining or when the
temperature in the Ice Container reaches 8°C.

Add More Ice

Check the temperature on the Outer Display to make sure that it is steady and below 8°C.

If the temperature reaches 5°C, LifePort Kidney Transporter displays a visual alert and an audible beep. Open
LifePort Kidney Transporter Cover and visually check the ice level.

If the ice is mostly melted, remove some water from the Ice Container (using a cup, scoop, hand pump, or

electrical pump) and rell with ice.

NOTE: This is part of the non-sterile section of LifePort Kidney Transporter and can be performed without
interrupting perfusion.

Replace Batteries

Check the battery level on the Message Display Panel. Whenever LifePort Kidney Transporter is not in transit,
plug LifePort Kidney Transporter into an external power supply so that the batteries are maintained in a
charged condition.

If the batteries are running low, plug LifePort Kidney Transporter into an external power supply, if possible.

If an external power supply is not available, the depleted LifePort Kidney Transporter batteries may be replaced
with fully charged LifePort Kidney Transporter batteries. Batteries may be replaced one at a time without
disrupting LifePort Kidney Transporter function.

CAUTION: Replace the batteries only one at a time to ensure that LifePort Kidney Transporter will
continue to operate.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 24

Remove Kidney From LifePort Kidney Transporter

The procedure for removing the kidney from LifePort Kidney Transporter is detailed below. This procedure may

be modied as necessary.

CAUTION: Where noted, perform the following procedure on an aseptic eld using standard aseptic
technique.

1. Unlatch and remove LifePort Kidney Transporter Cover.

2. Remove the Outer Perfusion Circuit Lid and place upside-down on a table where it will be undisturbed.

3. Using standard aseptic technique, carefully place LifePort Kidney Transporter Disposable Sterile Drape
onto LifePort Kidney Transporter, lining up the drape gasket and the well of the Outer Perfusion Circuit Lid.
Ensure the arrow on the orientation guide is pointing toward the Pump Deck.

4. Using standard aseptic technique, unfold Sterile Drape in the following order: right, left, front, and back.

The drape gasket should t securely into the well of the Outer Perfusion Circuit Lid.

5. Using standard aseptic technique, unlatch and remove the Inner Perfusion Circuit Lid. Place the lid

facedown onto the sterile eld.

6. Press the STOP button.

7. Using standard aseptic technique, unscrew or cut the Infuse Line.

8. Using standard aseptic technique, carry the Kidney Cradle, with the cannulated kidney, to the sterile eld.

9. Using standard aseptic technique, unhook the Mesh Organ Restraint.

10. Using standard aseptic technique, unstrap, open, and remove the cannula.

11. Using standard aseptic technique, perform any pre-transplant preparation on the kidney.

12. Once the kidney has been removed from the LifePort Kidney Transporter and accepted by the transplant
surgeon, proceed to Clean Up After A Case.

Clean Up After A Case

All LifePort Kidney Transporter Disposables and perfusate are single use devices and should go into medical
waste disposal.

WARNING: Use Universal Precautions when performing perfusate cleanup to prevent possible contact
with blood borne pathogens.

LifePort Kidney Transporter does not come in contact with the donor organ. The donor organ should always be
within the sterile eld provided by LifePort Kidney Transporter Disposable Perfusion Circuit and LifePort Kidney
Transporter Disposable Sterile Drape.

LifePort Kidney Transporter and Power Cord should return to the Home Base Station where LifePort Kidney
Transporter can be cleaned and disinfected with a 70% Isopropanol solution to remove perfusate residue.
Additionally, the batteries should be recharged and the supply kits should be repacked in preparation for the
next transplant.

WARNING: Do not use cleaning solutions containing acetone, ammonia, benzene, xylene, or similar
solvents. Do not use abrasive cleaning tools or pressurized spraying devices. Do not clean or disinfect
by autoclave or sterilize with EtO gas. Doing so will void the warranty.

CAUTION: Do not clean LifePort Kidney Transporter with the external power supply connected.

CAUTION: Do not immerse LifePort Kidney Transporter in water or cleaning solution.

CAUTION: Do not allow cleaning solutions to enter the electrical connectors, ventilation holes, or battery

area.

CAUTION: Ice Container and Ice Container Lid are reusable parts of the LifePort Kidney Transporter. Do
not dispose of them.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

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Data Capture and Download (Optional)

Optionally, data being generated and stored on LifePort Kidney Transporter can be downloaded and stored on
a computer.

NOTE: LifePort Kidney Transporter is designed to transmit historical data, excluding perfusion commands. The
Data Cable plugs into the Data Port, a USB connector on the External Connections Panel. Whenever LifePort
Kidney Transporter is in Infuse Mode, it captures perfusion and status data every 10 seconds.

Using A Computer

Data recording begins when LifePort Kidney Transporter enters the Infuse Mode for the rst time after
powering on. Data recording continues until LifePort Kidney Transporter is turned o󰀨.

To start a new data le, cycle the power (power o󰀨, then power on). LifePort Kidney Transporter can store
a maximum of ve perfusion cases at a time. Files should be downloaded to a computer after each case is
nished. After downloading, the cases can be deleted from LifePort Kidney Transporter.

Each LifePort Kidney Transporter data le can hold up to 48 hours of perfusion data. If a single perfusion case
runs longer then 48 hours, a new le can be created only by cycling the power and resuming the perfusion.

The stored data includes:

• Sequential record number

• Infuse time

• Pressure setpoint

• Average pressure

• Measured systolic and diastolic pressures

• Flow rate

• Organ resistance

• Ice Container temperature

• Bubble Trap temperature

• Error condition status (presence or absence of each error condition)

• Perfusion system state and sub state

• LifePort Kidney Transporter Cover status (open/closed)

CAUTION: Accessory equipment connected to the Data Port must be certied IEC950 for data
processing equipment. Furthermore, all congurations shall comply with the systems standard
IEC60601-1-Sec. 16. Any person who connects additional equipment to the Data Port congures a

medical system and is therefore responsible for ensuring that the system complies with the system
standard IEC60601-1-Sec. 16. If in doubt, consult the Organ Recovery Systems 24/7 Perfusion Helpline.

Using A Flash Drive

If a computer is not readily available for evaluating the data le, you can download the le onto a ash drive

and evaluate the data on a computer when one is available.

1. Power on LifePort Kidney Transporter.

NOTE: If LifePort Kidney Transporter does not have a Perfusion Circuit installed, press STOP to clear
the “Sensor Not Connected” error and press OK.

2. Insert USB ash drive into USB-A port on LifePort Kidney Transporter.

3. Use the arrow buttons to select DOWNLOAD FILE.

4. Use arrow buttons to select le to download.

5. Press OK and SAVE. Top display will ash SAVING FILE until complete. When download is complete,

display will return to download le screen.

6. You can download additional les, if desired, or use the arrow buttons to select DONE and press OK.

7. Remove the USB ash drive.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 26

Troubleshooting and Diagnostics

Most problems that you encounter in operating LifePort Kidney Transporter will be easily solved. The rst thing

to check when troubleshooting is to make sure that power is available from either the batteries or through
the Power Cord plugged into a standard electrical outlet. If the power light comes on but LifePort Kidney
Transporter still does not work, check the following guide.

Troubleshooting Procedures

Trouble Probable Cause Action

1. Replace with fresh batteries or plug into an external power
supply. Make sure batteries are fully charged before using.

No Power

Beeping or
Flashing LEDs

Missing/Incorrect
Display

Leaking
Perfusate

Leaking Coolant

Unresponsive
Buttons

Dead Batteries

Outlet

Tripped Circuit
Breaker

Beeping or
Flashing LEDs Are
Accompanied by an
Error Message

Display or Internal
Computer Error

Perfusion Circuit Lids
Not Tightened

Defective Perfusion
Circuit

Broken Ice Container
or Seal

Internal Lock-up

2. Make sure the outlet has power.

3. Reset breaker by pressing the button on the External
Connections Panel located on the back of LifePort Kidney
Transporter.

If problem is not resolved, please call Organ Recovery Systems
24/7 Perfusion Helpline.

Follow the instructions in Error Message Explanations.

If problem is not resolved, please call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Power OFF.

2. Power ON.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

1. Relatch the Perfusion Circuit Lids and look for any leaks
near the gaskets

2. Replace the Perfusion Circuit. Call Organ Recovery
Systems 24/7 Perfusion Helpline to return Perfusion Circuit
for investigation.

If problem is not resolved, call Organ Recovery Systems 24/7
Helpline.

Observe the Ice Container for any damage.
If damaged or if problem is not resolved, call Organ Recovery
Systems 24/7 Perfusion Helpline.

1. Power OFF.

2. Disconnect Power Cord.

3. Remove all batteries.

4. Wait 30 seconds.

5. Return batteries to LifePort Kidney Transporter

6. Power ON.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

1. Power OFF.

Blank Message
Display

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

27

Display or Internal
Computer Error

2. Power ON.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

Error Message Explanations

LifePort Kidney Transporter sounds audible alerts when it encounters out-of-range conditions for bubbles,
pressure, ow, and temperature. Many of these errors are self-correcting and perfusion will automatically
resume.

LifePort Kidney Transporter enters a fail-safe mode of static cold storage if any unrecoverable fault condition is
encountered.

Scroll through the Message Display Panel to view all of the fault conditions. The error indicators will remain
viewable until cleared.

To clear the indicators for errors, which are no longer valid, press either the STOP or PLOT/CLEAR button, as
advised on the screen.

Check the following list of abbreviations, observed problems, probable causes, and recommended actions.
In most cases the audible alert can be cancelled or temporarily muted by pressing either the STOP or PLOT/

CLEAR button, depending on the type of alert.

Error Message Probable Cause Action

1. Check Perfusion Circuit for leaks and the connection to the

cannulated kidney, using standard aseptic technique when

Bubbles in Infuse
Line

Can’t Reach
Pressure

Check Ice

Check Filter Filter May Be Clogged

High Pressure

Kidney High
Resistance

Air bubble in the
Infuse Line

Leaking Cannula or
Artery

Leak in Perfusion
Circuit

Low Resistance
Kidney

The Ice Container
Temperature is 5°C or
higher but still below
8°C

System Experiencing
Unexpected Pressure
Conditions

System Measuring
Excessively High
Resistance

necessary. Correct any leaks, under aseptic conditions, if
necessary.

2. Re-prime the Perfusion Circuit.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

1. Under aseptic conditions, visually inspect the connection to
the cannulated kidney and correct any leaks, if necessary.

2. Check Perfusion Circuit for leaks. Replace Perfusion Circuit
if leaks cannot be corrected.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

Replenish ice before temperature reaches 8°C, otherwise
LifePort Kidney Transporter will cease perfusion and revert to
static cold storage.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

1. Do not attempt to dislodge obstruction from lter.

2. Replace Perfusion Circuit.

3. Contact Organ Recovery Systems 24/7 Perfusion Helpline to
return Perfusion Circuit for investigation.

1. Inspect Pressure Sensor and Pressure Sensor Connector.

2. Under aseptic conditions, check for arterial and venous
obstructions.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

1. Under aseptic conditions, loosen Mesh Organ Restraint.

2. Under aseptic conditions, adjust position of renal artery.

3. Under aseptic conditions, check for occlusions within the
Perfusion Circuit.

4. Consult supervising physician.

If problem is not resolved, call Organ Recovery Systems 24/7
Perfusion Helpline.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 28

Error Message Probable Cause Actions

1. Check Tubeframe and Locking Arm position.

2. Under aseptic conditions, visually inspect kidney
and cannula and correct all leaks under aseptic
conditions.

If problem is not resolved, call Organ Recovery Systems

Kidney Not
Connected

Tubeframe Not
Positioned Properly
Leaking Cannula or Artery
Kidney Not Connected

24/7 Perfusion Helpline.

1. Check Tubeframe and Locking Arm position.

Load Perfusion
Circuit

The Tubeframe Not Properly
Installed or Latched

2. Check Pressure Sensor Cable connection.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Plug into external power supply.

2. Hot swap batteries for charged batteries.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Call the Organ Recovery Systems 24/7
Perfusion Helpline.

1. Check that ice and water only are used to ll Ice
Container.

2. Move LifePort into a warmer environment.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Low Battery

Motor Current
Failure

Near Freezing

Less Than 4 Hours Battery
Life Remaining: 2 Hours
Perfusion Plus Additional 2
Hours Monitoring

LifePort Not Responding
Normally

Incorrect Coolant
Environmental
Conditions Too Cold (Ice
Container temperature has
dropped below 0.1°C)

1. Under aseptic conditions, check that Infuse Line is
unobstructed.

Occlusion

Unexpected Pressures During
Infuse Mode

2. Under aseptic conditions, ensure there are no
blockages or twists in the artery.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Remove all power to LifePort Kidney Transporter:
remove all four (4) LifePort batteries and unplug from
AC Mains.

POST Failure Internal Error

2. Restore power to LifePort and press Power button.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Reconnect the Pressure Sensor.

Pressure Sensor
Failure

Pressure Sensor
Disconnected

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Press STOP to clear alert.

Pressure Sensor
Endpoint Error

LifePort Kidney Transporter
Unable to Set Pressure Alert
Levels

2. Press INFUSE to re-enter Infuse Mode.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Run LifePort Kidney Transporter in Wash Mode.

2. If this is a persistent error, check Perfusion Circuit for

cracks, leaks, and/or loose ttings.

If problem is not resolved, call Organ Recovery Systems

Purge Bubbles

Automatic Wash Cycle during
Infuse Mode
Possible Air Leak

24/7 Perfusion Helpline.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

29

Error Message Probable Cause Actions

Incorrect Coolant
Environment Conditions

Too Cold

Too Much
Pressure

Too Warm Add
Ice

Upstream
Bubbles

Watchdog Internal Error

Too Cold (Ice Container
temperature has dropped
below 0.5°C)

High G Forces Created
During Transit

Ice Container Temperature
Above 8°C

Air Persisting in Upstream
Bubble Detector

1. Check that ice and water only are used to ll Ice
Container.

2. Move LifePort into a warmer environment.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Cushion or reduce impact.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

1. Replenish ice as soon as possible.

2. Allow time for the temperature to read below 8°C
and press INFUSE to restart perfusion.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Check Perfusion Circuit for leaks.

If problem is not resolved, call Organ Recovery Systems
24/7 Perfusion Helpline.

Call the Organ Recovery Systems 24/7
Perfusion 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, temperature sensors, Bubble Detectors, and its
internal failure routines. In the unlikely event that one of these tests fail, LifePort Kidney Transporter will display
“POST failure” and it will list the POST error message as shown in the table below. Should one of these errors
occur, remove all power to LifePort Kidney Transporter by reinstalling the batteries and Power Cord. If the
POST message continues to display, call the Organ Recovery Systems 24/7 Perfusion Helpline.

POST Error Message Indication

POST AT error Ice Bucket temperature error
POST failure Power on self test failed
POST Flash error Integrity check of Flash memory
POST HPS error High pressure shutdown error
POST IB error Infusion Bubble Detector error
POST MD error Motor drive error
POST MOC error Motor overcurrent shutdown error
POST PS error Pressure Sensor error
POST PT error Perfusion temperature sensor error
POST RAM error Integrity check of Read Only Memory
POST ROM error Integrity check of Read Only Memory
POST UB error Upstream Bubble Detector error
POST WD error Watchdog error

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 30

Maintenance

Overview

LifePort Kidney Transporter has no user serviceable parts.

Maintain, clean, and keep LifePort Kidney Transporter ready to use according to the directions in this manual.
If LifePort Kidney Transporter is not functioning properly, refer to Troubleshooting and Diagnostics or
contact the Organ Recovery Systems 24/7 Perfusion Helpline.

Storage

If LifePort Kidney Transporter will not be used for several days or weeks, clean the device according to Clean
Up After A Case before storing. LifePort Kidney Transporter should be stored indoors in a dry location out of

direct sunlight.

For periods of storage for longer than 30 days, remove the batteries from LifePort Kidney Transporter.
Extended storage could damage the batteries.

Store LifePort Kidney Transporter in a temperature-controlled space. LifePort Kidney Transporter will operate
normally after storage in conditions ranging from 5°C to 40°C.

Repairs

If LifePort Kidney Transporter requires repairs it will need to be shipped by common carrier. Be sure to use
the corrugated carton, with foam inserts—either the original carton or the carton containing the loaner—as
provided by Organ Recovery Systems.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

31

Specications, Precautions, Limitations

Product Specications

Description

Indications for Use

Capacity Single kidney

Power Source

Coolant Source Ice/water bath, 5-1/2 Liters
Perfusate Pump Peristaltic pump
Pressure Control Closed loop pressure regulation, 10 to 65 mmHg
Perfusion Modes Pulsatile
Flow Rates Between 20 mL/min to 150 mL/min, accuracy is ±15%
Dimensions 24” x 14.5” x 14.25” (61.96cm x 36.83cm x 36.195cm)
Approximate Weight 45 lbs (20.4 kg) fully loaded

Transport Duration

Batteries Four x 11.1 V lithium-ion batteries
Battery Life 24 hours (fully charged)
Perfusate Used Hypothermic machine perfusate

Data Download

Storage Conditions Temperature: 5°C to 40°C

Operating Conditions

Portable, self-contained renal preservation system, which
utilizes hypothermic perfusion.

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.

AC or battery
Voltage – 100 to 240 VAC, Frequency – 50 to 60 Hz,
Current – 1 Amp

Up to 24 hours between ice replenishment and battery
replacement (or recharge)

USB data download of all perfusion and status data collected
since the point when the INFUSE state was begun following
Power ON.

Not to exceed 35°C on Mains
Not to exceed 40°C on battery

Device Classications

Medical Device

Type of protection from
electric shock

Protection from water
ingress

Cleaning recommendations

Equipment is suitable for Continuous Operation.

CAUTION: Equipment is NOT suitable for use in the presence of a FLAMMABLE ANESTHETICS,
OXYGEN, or NITROUS OXIDE, without proper safety precautions per hospital or organzation guidelines

or procedures.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 32

Class II FDA listed device

Class IIa EU MDD 93/42/EEC

Class I / Internally Powered

IPX1

LifePort Kidney Transporter can be cleaned with a 70% Isopropanol
solution to remove perfusate residue and other detritus.

LifePort Kidney Transporter is
protected from vertical water droplets

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 o󰀨. 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 a󰀨ect LifePort Kidney Transporter.

WARNING: To assure compliance with EMC requirements, use only manufacturer-supplied cables, as
shown below. If you have questions, contact the Organ Recovery Systems 24/7 Perfusion Helpline.

Data Cable Part # AK67222
Power Cord Part # 17664 (US only, contact the Organ Recovery Systems 24/7 Perfusion

Helpline for international Power Cord part numbers)

WARNING: Use of Power Cords or communications cables, other than those specied, may result in

increased emissions or decreased immunity of LifePort Kidney Transporter.

WARNING: 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 conguration in which it will be used.

Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC EMISSIONS

LifePort Kidney Transporter is intended for use in the electromagnetic environment specied 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

RF emissions

CISPR11

Harmonic emissions

IEC 61000-3-2

Voltage uctuations/icker

emissions

IEC 61000-3-3

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.

Class A The LifePort is suitable for use in all

establishments, other than domestic

Class A

Complies

establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

33

Guidance and Manufacturer’s Declaration — ELECTROMAGNETIC IMMUNITY

LifePort Kidney Transporter is intended for use in the electromagnetic environment specied below. The customer or the

user of LifePort Kidney Transporter should assure that it is used in such an environment.

Electromagnetic

Immunity Test IEC 60601 test level Compliance level

Electrostatic discharge
(ESD)
IEC 61000-4-2

Electrical fast transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11

Power frequency (50-60 Hz)
magnetic eld

IEC 61000-4-8

±6 kV contact
±8 kV air

±2 kV for power supply
lines

±1 kV di󰀨erential mode

±2 kV common mode

<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70% UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec

3 A/m 3 A/m Power frequency magnetic elds

±6 kV contact
±8 kV air

±2 kV for power supply
lines

±1 kV di󰀨erential mode

±2 kV common mode

<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70% UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec

Environment: Guidance

Floors should be wood,

concrete or ceramic tile. If oors

are covered with synthetic
material, the relative humidity
should be at least 30%.

Mains power quality should be

that of a typical commercial or
hospital environment.

Mains power quality should be

that of a typical commercial or
hospital environment.

Mains power quality should be

that of a typical commercial or
hospital environment. If the user
of LifePort Kidney Transporter
requires continued operation
during mains power interruptions,
LifePort Kidney Transporter can
be lowered from the internal
battery.

should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

UT is the AC mains voltage prior to application of the test level.

755-00002 Rev P 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 specied below. The customer or the

user of LifePort Kidney Transporter should assure that it is used in such an environment.

Electromagnetic

Immunity Test IEC 60601 test level Compliance level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz

3 V

3 V/m

Environment: Guidance

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

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 xed 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 a󰀨ected by absorption and

reection from structures, objects and people.

a Field strengths from xed 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 xed RF
transmitters, an electromagnetic site survey should be considered. If the measured eld 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, eld strengths should be less than 3 V/m.

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

35

Recommended Separation Distances Between Portable and Mobile RF

D= 3.5

[

]

√

D= 3.5
10

[

]

√

D= 7
10

[

]

√

Communications Equipment and LifePort Kidney Transporter

LifePort Kidney Transporter is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of LifePort Kidney Transporter can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and LifePort
Kidney Transporter as recommended below, according to the maximum output power of the communications equipment.

Rated maximum
output power or
transmitter (W)

0.01 0.12 0.04 0.07

0.1 0.37 0.11 0.22

1 1.17 0.35 0.70

10 3.69 1.11 2.21

100 11.67 3.50 7.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters

(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output

power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by absorption and

reection from structures, objects and people.

150 kHz to
80 MHz

Separation distance according to frequency of transmmitter (m)

P

3

80 MHz to
800 MHz

P

808 MHz to
2�5 GHz

P

Operational Precautions and Limitations

The following information will a󰀨ect the success in using LifePort Kidney Transporter.

Should Be Used Only By Trained Professionals — Federal law restricts the sale of this device to physicians
and medical professionals only. Use of the device in procedures other than those described in this manual may
result in injury.

Do Not Reuse Perfusion Circuits or Cannulas — The Perfusion Circuits, Sterile Drapes, and cannulas are
sterile as supplied and are intended for single-use. The method of sterilization is ethylene oxide gas. After use,
they should be disposed of in accordance with local guidelines for biomedical waste.

Use Only Manufacturer-Approved Accessories — Only manufacturer-approved accessories (e.g., batteries,
Perfusion Circuits, Power Cable, data cable) are designed to work properly with LifePort Kidney Transporter.
Do not substitute other batteries, Perfusion Circuits, cables, or accessories.

Use Only Ice and Water in the LifePort Ice Container — A mixture of ice and water in the Ice Container
will assure that temperatures remain within the appropriate range for kidney preservation in LifePort Kidney
Transporter. To avoid inadvertently freezing the kidney, ONLY USE ICE AND WATER in LifePort Kidney
Transporter Ice Container.

Single Use Only Disposables — LifePort Kidney Transporter Disposables are intended for single use only.

Disposables Already Sterile — LifePort Kidney Transporter Disposables are sterile as supplied. Do not

resterilize.

Connect the System to an External Power Supply According to Labeling—LifePort Kidney Transporter
uses externally supplied electricity to operate. Check the voltage and amperage ratings of the external supplies
and make sure they match the labeled ratings for electricity inputs shown on the rear of LifePort Kidney
Transporter.

Assure Adequate Ventilation—Do not block the ventilation areas on the side and bottom of LifePort Kidney
Transporter, especially when external power is connected.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 36

Electromagnetic Compliance—LifePort Kidney Transporter has been tested and found to comply with the
limits for a Class A digital device, pursuant to Part 18 of the FCC rules and to the Medical Device Directive
93/42/EEC and to the Electromagnetic Compliance (EMC) Directive 89/336/EEC. These limits are designed to
provide a reasonable protection against normal interference in a commercial or hospital setting.

LifePort Kidney Transporter needs special precautions regarding EMC and should be used in accordance with the
EMC information provided in this manual. Please refer to Electromagnetic Compatibility for details.

Air Transport—Prior to beginning air transport, make sure that ice and Battery levels are su󰀩cient for

entire transport duration. Do not connect LifePort Kidney Transporter to an external electrical power source
on a commercial aircraft. Do not connect the Data Cable to LifePort Kidney Transporter during ight on a
commercial aircraft.

CAUTION: All LifePort Kidney Transporter users should be familiar with Organ Recovery Systems
Kidney Perfusion Solution (KPS-1®) Instruction For Use (IFU).

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

37

Hazards

Overview

This section contains information on hazards involved in using LifePort Kidney Transporter that can pose risk

to the operator as well as to the environment—information that will a󰀨ect clinician and sta󰀨 safety when using

LifePort Kidney Transporter.

WARNING: Possible Explosion Hazard. Do not use LifePort Kidney Transporter in the presence of

ammable anesthetics. LifePort Kidney Transporter is not designed for use in the presence of explosive

mixtures of anesthetic gases with air, oxygen or nitrous oxide. USE ONLY IN SAFE ENVIRONMENTS.

WARNING: Do not open LifePort Kidney Transporter to service it. Shock hazard exists if Pump Deck is

removed. All aspects of LifePort Kidney Transporter that are meant to be attended by the Operator are
accessible without opening the Device. If there is a service problem, please call the Organ Recovery
Systems 24/7 Perfusion Helpline.

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.

WARNING: Unauthorized modications to LifePort Kidney Transporter will void the warranty and may

damage the device and/or organ. This may also result in user being harmed.

CAUTION: Use Universal Precautions with the kidney and perfusate. The kidney and perfusate may
carry undetected pathogens from 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 to prevent the possible transmission of pathogens to
medical personnel.

CAUTION: Do not clean LifePort Kidney Transporter while connected to an external power supply.

CAUTION: Do not immerse LifePort Kidney Transporter.

CAUTION: Do not allow cleaning solutions to enter the rear panel electrical connectors, the ventilation

holes, or the battery area.

CAUTION: Use precautions when lifting. A fully loaded LifePort Kidney Transporter weighs 45 lbs (20.4
kg). Use proper lifting practices to avoid injury.

CAUTION: Local regulations must be followed for the disposal of LifePort Kidney Transporter and
lithium-ion Batteries. If in doubt, call the Organ Recovery Systems 24/7 Perfusion Helpline.

CAUTION: Use only grounded electrical connections. Connect LifePort Kidney Transporter to a
grounded electrical outlet rated for voltage and amperage according to the labeled ratings on the product

back panel. If there is any question about the ground integrity, operate LifePort Kidney Transporter from

internal power.

CAUTION: You may remove mains power by unplugging the Power Cord from the back of the unit.
Exercise care when choosing the location of your LifePort Kidney Transporter so that removal of Power

Cord is not di󰀩cult.

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 38

Index

A

abbreviation 1
Accessories 6, 36
Air bubble 28
Air Transport 37
alert 3, 11, 21, 22, 23, 24, 28, 29
anvil 18
aortic patch 18
audible beep 10, 16, 24

B

Batteries 6, 7, 12, 14, 24, 27, 32, 38
Battery Door 6, 7, 12
battery power 12, 22
BLOOD TYPE 11, 17
Bubble Detector 30
Bubbles in Infuse Line 28
Bubble Trap 4, 5, 8, 11, 12, 22, 26

C

cannula 7, 8, 14, 18, 19, 20, 21, 23, 25, 29, 36, 39
Cannula Mount 8, 19, 20, 21
Cannulate the Kidney 18
cannulation 20, 21
Can’t Reach Pressure 28
Check Filter 28
Check Ice 22, 28
Circuit Breaker 27
Clean Up After A Case 25, 31
Clean Up and Review after Use 13
common carrier 31
Compliance Chamber 8
Contraindications 3
Control Panel 3, 4, 9, 10
LifePort Kidney Transporter Disposable Coupler 19
LifePort Kidney Transporter Cover 10, 13, 20, 24,
25, 26
CROSS CLAMP TIME 17

D

Data Cable 6, 26, 33, 37
Data Capture and Download 26
Data Port 2, 6, 26
Data Station 13, 17, 22, 23
DEVICE INFORMATION 12, 13
Disposable Products 7, 25
Disposal 7
Sterile Drape 7, 20, 21, 25
Duration of Operation 12

E

Electromagnetic Compliance 37
ENERGIZE 12
Enter Device Information 13
Enter ORGAN ID Information 17
Error Message Explanations 22, 27, 28
External Connections Panel 3, 6, 10, 26, 27

F

Fill LifePort Kidney Transporter Ice Container 15
Fill the Ice Container 10

lter 11, 28
ow rate 3, 22, 23

G

GPS/GPRS 13, 22
GPS/GPRS Tracking Capability 13

H

Hazards 1, 38
High Pressure 11, 21, 28
Home Base Station 9, 14, 25
hypothermic 3, 4, 14, 32

I

ice
crushed 9, 10, 15
pelletized 9, 10, 14, 15
Ice Container 3, 4, 10, 11, 12, 13, 14, 15, 24, 25, 26,
27, 28, 29, 30, 36
Ice Container Lid 10, 13, 15, 25
INFUSE 5, 10, 12, 21, 22, 29, 32
Infuse Line 8, 11, 12, 20, 21, 25, 28, 29
Infuse Mode 17, 22, 26, 29
Infusion Pump 5, 8, 10, 11, 16, 38
Intended Use 3
Isolate the Kidney Vascular Structure 17
isopropanol solution 13

K

KIDNEY 11, 17
Kidney Cradle 8, 16, 20, 21, 25
Kidney High Resistance 28
Kidney Not Connected 29

L

Label Graphics 2
Leaks 21, 23
LifePort Kidney Transporter Use 9, 14
Load LifePort Kidney Transporter Disposable
Perfusion Circuit 10, 16
Load Perfusion Circuit 29

LifePort Kidney Transporter Operator’s Manual 755-00002 Rev P

39

loaner 31
Low Battery 29

M

Maintain LifePort Kidney Transporter for Quick
Response Use 14
Maintenance 31
Mesh Organ Restraint 8, 20, 25, 28
Message Display Panel 6, 11, 24, 28

O

Operational Accessories 6
Operational Precautions and Limitations 1, 36
ORGAN INFORMATION 11, 12, 17
Outer Display 3, 4, 9, 10, 11, 12, 21, 22, 24

Specications, Precautions, Limitations 32

LifePort Kidney Transporter Disposable Sterile Drape
7, 20, 25
storage 4, 7, 9, 28, 31
LifePort Kidney Transporter Disposable Straight
Cannula 19
System Description 3

T

Test Operating Modes 11
Travel with LifePort Kidney Transporter and Supplies
15
Troubleshooting and Diagnostics 9, 11, 31
Troubleshooting Procedures 27
Tubeframe 5, 8, 10, 16, 29
Tubing Circuit 8, 11

P

perfusate 3, 4, 5, 7, 8, 9, 14, 16, 21, 22, 25, 32, 38
perfusion 1, 3, 4, 5, 8, 14, 17, 21, 22, 23, 24, 26, 28,
32
LifePort Kidney Transporter Disposable Perfusion
Circuit 3, 5, 7, 8, 10, 13, 16, 20, 25
Perfusion solution 14
Physical Description 3
Place the Kidney 19, 20
PLOT/CLEAR 22, 28
POWER 10, 12, 13, 15, 16
Power Cord 6, 10, 12, 14, 25, 27, 30, 33
preliminary testing 9
Prepare LifePort Kidney Transporter for Recovery 15
Prepare the Home Base Station 14
pressure 3, 4, 5, 8, 11, 12, 14, 21, 22, 23, 26, 28, 30,
32
Pressure Sensor Cable 5, 8, 10, 16, 29
Pressure Sensor Connector 8, 10, 16, 28
pressure setting 21
PRIME 5, 10, 11, 21, 22
Pump Deck 3, 4, 5, 8, 10, 16, 20, 25, 38
Pumphead Raceway 5, 10, 16
Pump Tubing Loop 5, 8, 10, 16

U

LifePort Kidney Transporter Disposable Universal
SealRing 18
Unpack and Inspect 9
Unpack, Setup, and Run Preliminary Tests 9

W

WASH 5, 10, 11, 22
Wash Line 5, 11
Wash Mode 11, 29

R

recharge 7, 32
Repairs 31
Resistance 11, 22, 23, 28
Run Preliminary Tests 9

S

Safety 3
LifePort Kidney Transporter Disposable SealRing
Cannula 18
Select a Home Base Station 9
shipping 9

755-00002 Rev P LifePort Kidney Transporter Operator’s Manual 40