4
•
Exercise care when inserting or removing the device. Excessive bending
of the device distal tip can cause the Benesta
TM
Tissue Removal Device
cutter to come out of the cutting window. If such damage occurs, replace
the device immediately.
Benesta
TM
Tissue Removal Device
CAL-TR1511 (1 pack)
CAL-TR1513 (3 pack)
The hand-operated Benesta
TM
Tissue Removal Device is shown below in
Figure 1. The parts of the device are listed below:
Figure 1. Benesta
TM
Tissue Removal Device
Safety Switch: This switch turns power to the entire device on or off
depending on the position of the switch. During shipment, the position is
in the “off” (O) position to prevent any accidental activation. The safety
switch must be turned to the “on” (I) during the preparation phase of an
operative procedure for the device to function and resect tissue.
Trigger: Depressing the trigger actuates cutting action. The device will
continuously cut and allow the passage of fluid and tissue while the
trigger is depressed and will stop as soon as the trigger is released. The
cutting window will remain closed while cutting is not activated, but will
still allow for some fluid outflow in this position.
Outflow Tubing: the outflow tube removes waste fluid and resected
tissue through a compatible suction canister and tissue trap.
Cutting Window: side-facing cutting window at the distal tip
Cutting Window Indicator: indicates orientation of cutting window when
cutting window is not under direct visualization
Distal Tip Locating Mark: Indicates depth relative to hysteroscope and
can be used during initial insertion of the tissue removal device into the
hysteroscope.
Pathology Measurement Lines: contains markings spaced 1mm apart to
help estimate pathology size under direct visualization
Components not included with the Benesta
TM
Tissue Removal Device:
–
Under-buttocks drape
–
IV Pole, pressure cuff or fluid management system (FMS)
–
Distending media
–
Vacuum source, suction canister and tissue trap
–
Benesta
TM
Hysteroscope and outflow channel
–
Inflow tubing
–
Y-tubing
–
Hysteroscope and outflow channel end cap seals
SET-UP
Please review the system configuration diagram in Figure 2 for a diagram
of the system setup.
Figure 2. System configuration diagram
Distending Media Set-Up
•
It is strongly recommended that isotonic media such as 0.9% Normal
Saline or Ringer’s Lactate be the media used for distending the
endometrial cavity.
•
Either a purpose-built hysteroscopic fluid management system or a
protocol for manual estimation of systemic absorption should be in place.
•
For purpose-built fluid management systems, carefully follow the
manufacturer’s instructions.
•
If using a manual fluid management system:
–
Procure an intravenous (IV) pole from which to hang either a 1L or
3L bag of distending media at least 40 inches above the patient’s
uterus
–
A pressure sleeve may be placed around the fluid bag to increase
inflow and uterine pressure and improve visualization during the
procedure.
–
When using the Benesta
TM
Hysteroscope, open the packaging for the
Y-tubing and connect it to the hysteroscope inflow ports. Connect the
Y-tubing to the fluid bag containing distention media using
compatible inflow tubing.
–
When using with the Benesta
TM
Hysteroscope (and/or outflow
channel), make sure the single-use seal is installed in the
hysteroscope (and/or outflow channel).
•
Position an under-buttocks drape with an integrated fluid reservoir or
similar fluid collection system that allows estimation of fluid volume.
•
Connect the outflow tubing to a tissue trap in line with tubing that
attaches to an appropriate suction canister.
•
Attach the suction canister to the regulated vacuum source which is set
to approximately 250 mmHg.
–
Make sure the lid is securely attached to the cannister prior to using.
Safety
Switch
Outflow
Tubing
Trigger
Distal Tip
Locating Mark
Cutting Window
Cutting Window Indicator
Pathology Measurement. Lines
