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Introduction and Safety
X
TRA
Operator’s Manual
20077/021 US
1-3
Indications for Use
The X
TRA
is indicated for use for intraoperative recovery of blood, washing of blood collected in the
postoperative period and preoperative sequestration (with indirect patient connection).
Typical clinical applications of autotransfusion include the following surgical specialties:
• Cardiovascular
• Orthopedics
• Thoracic
• Transplant surgery
• Emergency (trauma)
• Neurosurgery
• Obstetrics and gynecology
• Urology
Contraindication for Use
There are no known contraindications for the X
TRA
. However, the use of blood processed by this device
may be contraindicated under some circumstances (see Warning #22 and #23). The responsibility for
the use of the device in all cases belongs solely to the physician in charge.
General Warnings
1. The use of operating or maintenance procedures other than those published by LivaNova
(hereafter referred to as “the company”), or the use of accessory devices not recommended by
the company may result in patient injury or loss of life. The company will not be responsible for
patient safety or equipment performance if the procedures to operate, maintain, and calibrate the
X
TRA
system are other than those specified by company. Persons performing the procedures must
be appropriately trained and qualified.
Any equipment modifications must be performed by qualified persons and be approved in writing
by the company.
All electrical installations must comply with all applicable local electrical codes and company
specifications.
2. Read the instructions carefully prior to use. Prior to use, this manual must be thoroughly read and
understood by the personnel assigned to operate the system. Improper use may cause personal
injury and damage to the equipment. Improper use, repair or modifications by unauthorized
personnel may invalidate any warranty agreement. In X
TRA
displayed information and in these
instructions for use, the meaning of “fatal alarm” expression is considered as equivalent to “fatal
error”. The expression “fatal alarm” has been adopted because it is considered more familiar to
the user, but, from regulatory point-of-view, it must be considered as “fatal error”. In a similar
way, in X
TRA
displayed information and in these instructions for use, the meaning of “alarm”
expression is considered as equivalent to “information signal”.
3. The X
TRA
must be operated only by qualified personnel, trained in the use of the unit.
Qualified
and trained personnel
’ means personnel capable of operating according to the directions and
methods of use indicated in this manual.
4. Check the product thoroughly on delivery. Transportation and subsequent handling may cause
structural and functional damage to the unit.
5. X
TRA
should be overhauled by authorized service technicians every 12 months.
6. Disconnect the X
TRA
autotransfusion system from the power source prior to cleaning and
maintenance.
7. Do not use the X
TRA
in the presence of flammable agents because an explosion and/or fire may
result.