5
–
Connect the outflow vacuum tubing to the tissue trap connection on
the cannister lid.
OPERATION
1.
Prior to opening the device, inspect the package for any signs of
damage. If damage is found, do not use the device and contact
Technical Support.
2.
Open the device by peeling back the corner of the Tyvek® lid
completely to expose the device.
3.
Holding the tray securely, grasp the handle of the device firmly and pull
up to release the device from the tray.
4.
Remove connected outflow tubing and, leaving the end of the tubing
free, straighten out the tubing so that it is completely unwound.
5.
Turn the safety switch from the “off” (O) position to the “on” ( I ) position.
6.
Temporarily actuate the Benesta
TM
Tissue Removal Device trigger prior
to introducing into the working channel of the hysteroscope to ensure
that the power is on.
–
Do not operate the Benesta
TM
Tissue Removal Device in a non-
irrigated, open-air environment for an extended period of time as this
may cause damage to the device.
7.
Introduce the inactivated Benesta
TM
Tissue Removal Device through
the working channel of the hysteroscope until the distal tip of the tissue
removal device is visible under clear visualization.
–
When used with the Benesta
TM
Hysteroscope, the tip of the
Benesta
TM
Tissue Removal Device will extend approximately 3.2 cm
from the end of the hysteroscope.
8.
Actuate the Benesta
TM
Tissue Removal Device trigger for 2-3 seconds
while under clear visualization and away from any patient tissues to
prime the device with the distending media. You can also retract the
tissue removal device into the hysteroscope until the cutting window is
within the hysteroscope working channel to prime the device.
–
If the system is turned off for any reason or the treatment is
interrupted for any reason, remove the device from any tissue, wait
15 seconds and repeat steps 5 through 8 before continuing
9.
Rotate to align the cutting window with the target pathology. Rotating
the hysteroscope may be necessary to achieve desired visualization of
the cutting window and target tissue pathology.
10.
Bring the cutting window in proximity with the target tissue pathology.
11.
Press the trigger to actuate cutting action in a fashion that allows for
excision of the excised tissue.
–
The suction pressure and/or media infusion pressure can be
adjusted to optimize visualization and cutting performance.
–
Optimal function may be achieved by resecting the tissue in bursts of
a few seconds each. This may aid in maintenance of distension of
the endometrial cavity and facilitate monitoring of the cutting
progress as well as device orientation or position.
12.
Do not apply excessive leverage on the device by pushing hard into
target pathology. Excessive leverage on the device does not improve
cutting performance and may result in decreased performance and/or
unintended excision of tissue pathology.
13.
Excised tissue is collected in the tissue trap.
Ending the Procedure
1.
Retract the Benesta
TM
Tissue Removal Device into the hysteroscope
until the cutting window is within the hysteroscope working channel.
2.
Actuate the trigger for a few seconds to ensure that all tissue is
transferred into the tissue trap.
3.
Remove the Benesta
TM
Tissue Removal Device from the hysteroscope.
Device Disposal
Dispose of the Benesta
TM
Tissue Removal Device according to your
facility’s policies and local, state or Federal procedures for biohazardous
materials, sharp waste, and battery disposal.
Storage
•
The
Benesta
TM
Tissue Removal Device should be stored at room
temperature, away from moisture and direct heat.
•
The device should not be stored at temperatures below 40°F or above
120°F, or in conditions where the humidity is below 40% or above 60%.
Troubleshooting
•
If the device does not actuate, remove the device from the hysteroscope.
Turn the safety switch from the “off” (O) position to the “on” ( I ) position.
Temporarily actuate the trigger to ensure that the power is on before
reintroducing into the hysteroscope.
•
If the distal tip of the tissue removal device is not visible after insertion,
remove the device completely from the hysteroscope. Reintroduce the
inactivated device through the working channel of the hysteroscope until
the distal tip of the device is visible under clear visualization. If the issue
does not resolve, please check the hysteroscope for obstructions and/or
field of view. Ensure vacuum tubing is connected and functioning and
vacuum is set to 250mmHg minimum.
–
Note: If troubleshooting steps do not resolve the issue, please
contact Technical Support.
Electrical and Electromagnetic Safety
•
All equipment performance is considered to be safety-related
performance, including any degradation of performance caused by
reciprocal interference. If the product is not put into service in
accordance with the electromagnetic safety requirements in this manual
and fails to perform as specified, the procedure should be aborted
immediately, and biomedical engineering staff should be alerted to the
observed issues
•
The Benesta
TM
Tissue Removal Device is an applied part Type BF
device, meaning that it complies with specific requirement for protection
against electric shock. This device is not suitable for direct cardiac
application.
•
The type F applied part status of energized hysteroscopes intended for
use with a multiplicity of supply units and/or light guide cables is ensured
by, for instance, using only supply units having isolated light guide output
sockets
•
The standard operating voltage of the Benesta
TM
Tissue Removal Device
is 7.7V – 9.0V, and the operating current is ~0.2A.