System is on, but did
not successfully complete
the self-test or stopped
functioning during use –
A single-pulsed tone and
power button illuminates red
System is on, with a single
tone, and a flashing amber
instrument receptacle
display.
System is on, power button
illuminated green when
plugging in the instrument
a single tone is heard and
a red instrument receptacle
display is seen.
CoolSeal
Generator is on
™
and instrument is activated,
but system does not deliver
output – no tones or
activation display
Incomplete Seal / Reactivate
– Three-pulsed tone sounds,
amber activation display on
generator front panel and RF
output is disabled
Instrument is connected
but vessel sealing will not
activate
Bolder Surgical
Unit stored in a cold location
Recoverable Software Malfunction
Internal component malfunction or
Non-recoverable Software Malfunction
System initiated with faulty instrument
plugged into Instrument Receptacle
Incorrect or expired instrument
Instrument Failure
CoolSeal
Instrument is not usable with
™
software version
Instrument recognition failed due to in
intermittent connection
Recoverable Software Malfunction
Internal component malfunction or
Non-recoverable Software Malfunction
An alert condition exists
System does not detect vessel sealing
instrument
Internal component malfunction or
Non-recoverable Software Malfunction
Seal cycle was in excess of 5 seconds
OR
Handswitch was released before the
end tone sounded
Metal or other foreign object is grasped
within jaws
Tissue grasped within jaws is too thin
Pooled fluids around instrument tip
Instrument has been activated in
open air
Instrument is not fully seated in
instrument receptacle
Allow unit to warm to ambient temperature.
Use a backup CoolSeal
Contact your biomedical engineering department or a Bolder Surgical
technical service representative for assistance.
Internal component malfunction.
Disconnect Instrument.
Turn off the CoolSeal
™
Turn on the CoolSeal
™
Plug in the instrument.
Replace the instrument if it continues to Malfunction.
Ask your biomedical engineering department to check with the
manufacturer of the device.
For a software upgrade refer to the Software Upgrade section.
Remove instrument plug
Firmly re-insert the instrument.
Turn off the system, then turn the system back on.
Use a backup CoolSeal
Contact your biomedical engineering department or a Bolder Surgical
technical service representative for assistance.
Refer to the Alert Conditions section.
Firmly insert the connector into the receptacle on the CoolSeal
Generator front panel. Ensure the receptacle display is illuminated green
to indicate a CoolSeal
™
recognized.
Contact your biomedical engineering department or a Bolder Surgical
technical service representative for assistance.
Additional time and energy are needed to complete the sealing
cycle. Reactivate the seal cycle without removing or repositioning
the instrument.
Visually inspect seal before cutting.
Avoid grasping objects, such as staples, clips, or encapsulated sutures in
the jaws of the instrument.
Open the jaws and confirm that a sufficient amount of tissue is inside the
jaws. If necessary, increase the amount of tissue and repeat the procedure.
Minimize or remove excess fluids. Clean electrode tips and jaws with
a wet gauze pad.
Release activation button. Grasp tissue and activate the seal cycle.
Disconnect instrument, reconnect and wait a moment.
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Generator.
™
Generator.
Generator.
Generator.
™
instrument has been properly seated and
en - CoolSeal™ Generator
™
™
™
™