Hologic Myosure REACH 10-401FC Instrucciones De Uso página 6

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Electromagnetic Safety
• The MyoSure Tissue Removal System needs special
precautions regarding electromagnetic safety and
needs to be installed and put into service according
to the electromagnetic safety information provided in
the system's Operating Manual.
• The MyoSure XL Tissue Removal Device for Fluent
is only to be used with the Fluent Fluid Management
System. The Fluent Fluid Management System needs
special precautions regarding electromagnetic
safety.
• All equipment performance is considered safety-
related performance. That is, the failure or
degradation of the performance specified in this
manual may pose a safety risk to the patient or
operator of this equipment.
Note:
If the MyoSure Tissue Removal System is put
into service in accordance to the safety instruction
in this manual, the product should remain safe
and provide the performance listed above. If the
product fails to provide this level of performance, the
procedure should be aborted and the biomedical staff
alerted to the observed problem. The problem needs
to be corrected before continuing or starting a new
procedure.
MyoSure Tissue Removal Device
The MyoSure Tissue Removal Device is a single-
use device designed to hysteroscopically remove
intrauterine tissue. It is a hand-held unit which is
connected to the front panel of the controller (Control
Unit or the Fluent Fluid Management System) via
a 6-foot (1.8-meter) flexible drive cable and to the
collection canister or Out-FloPak, via a 10 foot (3-meter)
suction tube. Cutting action is activated by a foot pedal.
The suction pressure draws fluid and resected tissue
through the tissue removal device cutting window.
Refer to Table 1 for controller compatibility with the
different MyoSure Tissue Removal Devices.
4
Set-up: Control Unit
The tissue removal device is EtO sterilized. Verify that
the tissue removal device is sterile prior to use. Do not
use if the package is opened or damaged. Discard all
opened, unused devices.
Review the System Configuration Diagram in
1.
Figure 5. for set-up outline.
Foot Pedal
Place the control unit on top of a cart or other stable
2.
work surface. Plug the control unit power cord into
the rear panel connector and a grounded AC power
source.
Connect the foot pedal tube to the connector on the
3.
front of the control unit panel.
CONNECTING TISSUE REMOVAL DEVICE TO THE
CONTROL UNIT
Remove the tissue removal device from the sterile
1.
package.
Sterile person hands the flexible drive cable and
2.
vacuum tubing to the non-sterile person.
Non-sterile person inserts the flexible cable into the
3.
corresponding connection on the control unit as
shown in Figure 6.
The tissue removal device flexible drive cable has
4.
a keyed feature that serves to align the handpiece
cable to the control unit connector. The metal tab
on the connector is pushed down, the flexible cable
inserted and then the tab is released.
MyoSure Tissue Removal System IFU
CAUTION:
The tissue removal device
is intended for single use only. DO NOT re-
sterilize. DO NOT REUSE. Do not lubricate
tissue removal device. Discard tissue removal
device after use. Dispose of the tissue
removal device and packaging according
to your facility's policies and procedures
concerning biohazardous materials and
sharps waste.
WARNING-DANGER:
if used in the presence of flammable
anesthetics.
MyoSure
control unit
MyoSure Tissue Removal Device (See Table 1)
Figure 5. System Configuration
Risk of explosion
Vacuum Canister and
Vacuum Source