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freezing. This avoids inadvertent lesion creation.
• The Cardioblate
Probe contains pressurized refrigerant during
operation. Discontinue treatment immediately if a
breach in the probe is suspected, as this may
result in release of pressurized gas and injury to
the patient or the user.
• If an unanticipated event occurs, the injection of
refrigerant can be stopped at any time by
pushing the Stop Freeze button on the control
panel.
• If you are unable to stop the injection, turn the
system off by pressing the power switch on the
side of the control panel or by disconnecting the
power cord.
• Do not attempt to disconnect the probe during
operation in the freeze mode as the sudden
release of pressure may cause the probe to
recoil, which may injure the operator. The system
must be vented prior to disconnecting the probe.
• If the injection of refrigerant spontaneously stops
before the preset time on the control panel has
elapsed, replace the probe.
Precautions
• Only appropriately trained personnel in a fully
equipped facility should perform cardiac
cryoablation procedures.
• This device was designed for single patient use
only. Do not reuse, reprocess, or resterilize this
product. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the
device and/or create a risk of contamination of
the device which could result in patient injury,
illness, or death.
• Discard all used Cardioblate
Surgical Ablation Probes in accordance with
hospital procedures. Reuse may affect product
function.
• Prior to removing the Cardioblate
Surgical Ablation Probe from its packaging,
inspect the packaging to verify the integrity of the
seal. Use sterile techniques when handling the
product.
• Ensure that equipment used with the
Cardioblate
®
System is electrically safe and does not expose
the patient to hazards.
• Ensure that all pressure and regulator lines are
securely connected.
• Always turn off the main gas cylinder valve prior
to venting the inlet pressure line to ensure that
excess pressure is safely vented.
• Perform a test injection before placing the
ML_3966-000_RevA.indd 3
CryoFlex™ Surgical Ablation
®
CryoFlex™
®
CryoFlex™
®
CryoFlex™ Surgical Ablation
Cardioblate
CryoFlex™ Surgical Ablation
®
Probe on tissue to be ablated.
• Do not use Cardioblate
CryoFlex™ Surgical
®
Ablation Probes that are damaged in any way.
• Do not expose the probe, accessories, or
electrical connectors to cleaning fluids or
solvents.
• Follow standard guidelines for the safe handling
and storage of high-pressure gas cylinders.
• The Cardioblate
CryoFlex™ Surgical Ablation
®
Console meets the requirements of Underwriters
Laboratories (UL). It is the user's responsibility
after installation to verify and ensure that the
system meets the applicable electrical safety
requirements with respect to electric shock, fire
and mechanical hazards only in accordance with
UL 60601-1 and CAN/CSA C22.2 No 601.1.
• Do not disconnect the probe from the console
until the procedure is finished.
How Supplied
The Cardioblate
CryoFlex™ Surgical Ablation
®
Probe is supplied sterile. All packaging material is
recyclable. Manage disposal in accordance with
local statutory regulations.
How to Connect
Refer to the Operator's Manual for the Cardioblate
CryoFlex™ Surgical Ablation System for detailed
instructions about connecting the probe to the
control panel.
Directions for Use
IMPORTANT!
• Refer to the Operator's Manual for the
Cardioblate
CryoFlex™ Surgical Ablation
®
Console for detailed instructions.
• Refer to the warnings and precautions at the
beginning of this document.
Note: All ablation procedures must be performed in
a fully equipped operating room.
1. Prior to placing the probe on tissue to be
ablated, test the probe by pressing the Start
Freeze button on the control panel for at least
2 seconds while the probe is in the air. After
20 seconds, a temperature of –110° C or less
should be displayed.
2. With the probe turned off, manipulate the
ablation segment and shaft into the desired
shape. These can be straightened and bent as
needed although, to ensure optimal probe
performance, manipulate the probe only to the
extent needed to achieve the appropriate shape.
Avoid excessive bending of the ablation segment
and the probe shaft. Avoid bending the ablation
3
®
1/4/12 10:47 PM
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