LifePort Kidney Transporter Operator’s Manual 755-00002 Rev R
3
System Description
Intended Use
LifePort Kidney Transporter (LKT) is intended for use in continuous hypothermic machine perfusion of kidneys.
Indications for Use
LifePort Kidney Transporter is intended to be used for the continuous hypothermic machine perfusion of kidneys
for the preservation, optional transportation and eventual transplantation into a recipient.
Safety
LifePort Kidney Transporter is safe when used as described in this manual. It is designed to meet recognized
U.S. and international standards for medical equipment and systems, as stated by the Underwriters
Laboratories (UL) and the International Electrotechnical Commission (IEC).
Electrical and mechanical safety features have been designed into LifePort Kidney Transporter to ensure safe
operation.
These features are as follows:
• The electrical and electronic components are contained within a secure enclosure.
•
Perfusate temperature, flow rates, and
pressure levels are only adjustable within a set range, which
cannot be changed by the operator.
• Perfusate pressure,
flow rate, and temperature are continuously monitored.
• Display screens illuminate when the power is on. Stop, Wash, Prime, and Infuse controls are provided
and identified, depending on the mode of operation and options available.
• Acceptable operating ranges are established within LifePort Kidney Transporter for pressure,
temperature,
flow rate, battery charge state, bubbles in the perfusate, and configuration integrity.
Hardware and software interlocks are built-in to bring LifePort Kidney Transporter to a fail-safe condition
if an unacceptable operating state is detected.
• LifePort Kidney Transporter gives an audible alert and a descriptive message if an unacceptable
operating state is detected.
Contraindications
There are no known contraindications when used as directed.
Physical Description
LifePort Kidney Transporter is designed to integrate with the clinical environment by using readily available
supplies, requiring minimal user intervention, and by being easy to use. LifePort Kidney Transporter is a
portable, isolated kidney perfusion and transport system, designed to support a donated kidney and to
maintain the organ in a near-normal physiologic state under hypothermic aseptic conditions. An insulated
plastic housing encloses the kidney and perfusate within a LifePort Kidney Transporter Disposable Perfusion
Circuit. LifePort Kidney Transporter components include an Ice Container, Pump Deck, Control Panel, Outer
Display, Bubble Detectors, External Connections Panel, sensors, and four lithium-ion batteries. Two handles
make the unit easy to lift and carry.
