ArtiCure Isolator Transpolar pen Руководство по эксплуатации - Страница 5
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Печатать страницуWARNINGS
•
Do not touch the electrodes of the Pen
while activating the ASU. Touching the
Pen electrodes during ASU activation
could result in an electrical shock or
burn to the operator.
•
Do not touch the electrodes of the Pen
to metal staples or clips, or to sutures
while activating the ASU. This may
damage the Pen or tissue, or result in
an incomplete ablation.
•
Do not use abrasive cleaners or
electrosurgical tip cleaners to clean
debris from the Distal Tip. Do not turn
on ASU while cleaning the device.
Use of abrasive cleaners or
electrosurgical tip cleaners can
damage the electrodes and result in
device failure. Use saline-soaked
gauze for cleaning debris.
•
Do not immerse the Pen in liquids as
this may damage the device.
•
To avoid shock/burn hazards, always
wear the appropriate surgical gloves
when using the Pen and ASU.
•
To avoid shock/burn hazards, always
remove the Pen from the patient
during defibrillation.
•
No representation or warranty is made
that failure or cessation of function of
the device will not result in an adverse
event or that medical complication
(including tissue perforation) will not
follow the procedure, or that the use of
the device will in all cases restore
adequate cardiac function.
•
To avoid the risk of patient infection,
inspect the product packaging prior to
opening to ensure that the sterility
barrier is not breached. If the sterility
barrier is breached, do not use the
Pen.
•
The pen device is intended for single
use only. Do not RESTERILIZE.
Resterilization may cause loss of
function or injury to patient.
•
Use only connecting cables and
auxiliary device identified in this
Instruction for Use to avoid risk of
patient injury, operator injury, or
equipment damage.
•
Do not allow the connectors of the Pen
to get wet. Wet connectors may affect
the device performance.
•
Read auxiliary device manual and
observe warnings. The Pen can be
used with a temporary pacemaker.
•
Do not connect the ASB auxiliary
device cable to supply mains (line
voltage) operated equipment without
verifying isolation of the connected
equipment to EN60601-1-1. Supply
mains operated equipment may
introduce dangerous leakage currents
into the heart
•
An auxiliary device may have an
adverse effect on nearby radio or TV
transmissions. There may also be
cases when nearby electrical
appliances adversely influence the
auxiliary device, causing data errors or
malfunction.
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