XVIVO Liver Assist, Instructions For Use Manual

Page: 28 / 40

11.01.601.7c EN Page 28 of 40
15. Fill the thermo unit with 2 liters of demineralized water to prepare the unit for next
use.
Do not allow cleaning solutions to enter the air vents, back panel electrical connectors,
ventilation holes of the Liver Assist or the temperature, pressure or flow-sensor
connection at the side panel of the Liver Assist!
•
Federal law restricts the sale of this device to physicians and medical professionals
only.
•
Read these instructions and the instructions of the disposable set before use.
•
Use of the device in procedures other than those described in this manual may result
in injury.
•
Safe use of the Liver Assist can only be guaranteed when the operator is a skilled
and trained professional and has successfully followed a Liver Assist training
course.
•
Judgement of the measurement results regarding organ quality are of the
responsibility of the surgeon.
•
Start preparation of the recipient when the machine perfusion procedure is
completed.
•
The Liver Assist uses externally supplied electricity to operate. Connect the Liver
Assist to a grounded electrical outlet rated for voltage and amperage according to
the labeled ratings on the product back panel.
•
The POWER button on the Liver Assist will not completely shut off all power from
the device. The power supply of the Liver Assist thermo unit will still produce a low
noise when the Liver Assist is switched off.
•
The mains plug of the power supply is the separator that connects or disconnects
the Liver Assist from the mains. Avoid positioning the equipment such that access
to the mains plug, etc. is limited (so that disconnection becomes difficult).
•
Disconnecting mains in running mode will switch the device to back-up battery
power operation.
•
In case of emergency, and failing power button, disconnect pump head to stop
perfusion.
•
In the unlikely event that perfusion is unrecoverable, continue preservation using
static cold storage.
•
The power cord should remain connected to Mains to charge back-up battery.
Minimal charging time is 8 hours. The power cord should be unplugged from the AC
outlet when left unused for a long period of time.
•
Do not block the ventilation areas on both sides of the Liver Assist thermo unit, this
will affect the performance of the device.
•
Do not use outside prescribed operation environment, higher temperatures may
lead to less efficient cooling.
•
Do not install, use and/or store this unit in; a poorly ventilated room, environment
with flammable anesthetics, oxygen rich environment or in locations exposed to
direct sunlight or strong artificial light.
•
Yearly service by XVIVO is required to assure optimal and safe functioning of the
Liver Assist.