Technical Specifications - Hologic MyoSure Instrucciones De Uso

ENGLISH
Operation
1. Push the power switch to the ON ( ) position.
2. The foot pedal activates tissue removal device operation. The foot
pedal turns the motor ON and OFF. Once the foot pedal is depressed,
the tissue removal device accelerates and rotates to the set speed and
continues until the foot pedal is released.
3. Press the foot pedal and observe the tissue removal device action to
verify that the motor runs and that the cutting window is closed as
shown in Figure 5.
Figure 5. Closed Tissue Removal Device Cutting Window on Left
WARNING: Periodic irrigation of the tissue removal device tip
is recommended to provide adequate cooling and to prevent
accumulation of excised materials in the surgical site.
4. Introduce the tissue removal device through the straight 3 mm working
channel of a hysteroscope.
5. Under direct hysteroscopic visualization, position the tissue removal
device's side facing cutting window against target pathology.
CAUTION: Excessive leverage on the tissue removal device does not
improve cutting performance and, in extreme cases, may result in
wear, degradation, and seizing of the cutter assembly.
6. Press the foot pedal to activate the tissue removal device's cutting
blade.
7. The tissue removal device's reciprocating action alternately opens and
closes the device's cutting window to the vacuum flow thereby drawing
tissue into the cutting window.
8. Cutting takes place when the tissue removal device cutting edge
rotates and translates across the tissue removal device's cutting
window.
CAUTION: If it appears that the blade has stopped rotating during a
procedure, check to ensure that all connections to the tissue removal
device and the control unit (both mechanical and electrical) are
secure and that the drive cable has not wrapped into a loop.
NOTE: If system is turned off for any reason, wait at least 15 seconds
before turning power back on.
Storage
The tissue removal device should be stored at room temperature, away
from moisture and direct heat. Do not use after expiration date.
Sterility
The tissue removal device is EtO sterilized. DO NOT RE-STERILIZE. DO NOT
REUSE. Do not use if package is opened or damaged. Discard all opened,
unused devices.
release Date:08/16/19
Disposal
Disconnect the tissue removal device from the control unit. Dispose of the
tissue removal device and packaging according to your facility's policies
and procedures concerning biohazardous materials and sharps waste.
CAUTION: The tissue removal device contains electronic printed
circuit assemblies. At the end of the useful life of the equipment it
should be disposed of in accordance with any applicable national or
institutional related policy relating to obsolete electronic equipment.
Troubleshooting
The MyoSure Tissue Removal System is very simple to operate. The control
unit is switched ON using the front panel power switch. If the unit does not
operate, check the following:
1. Unit is plugged into wall outlet.
2. Wall outlet has power.
3. Power cord is attached to back of control unit.
4. Foot pedal has been connected to front panel.
5. Vacuum pressure is available.
6. Vacuum tubing is connected.
If excess force or bend is applied to the tissue removal device, the control
unit will shut off the timer display to protect the system. In this event,
switch the main power switch located in the front panel of the control unit
to OFF, wait for 15 seconds and then switch the main power switch to ON
to resume operation of the MyoSure Tissue Removal System.
NOTE: If the system is turned off for any reason, wait at least
15 seconds before turning the power back on.

Technical Specifications

Tissue Removal Device: 10-401
Sterile, single use device
Working Length: 12.6" / 32 cm
OD: 3 mm
Tissue Removal Device Accessories
Vacuum Source – 200–650 mm Hg
Olympus Vacuum Pump Model KV-5 or equivalent in compliance with
national version of safety standard, IEC 60601-1 (e.g., for USA UL
60601-1, for Europe EN 60601-1, for Canada CSA C22.2 No. 601.1, etc).
Vacuum Canister & Tissue Trap
Bemis 3000 cc Hi-Flow Canister Model 3002 055 or equivalent
Bemis Specimen Collection Adapter 533810 or equivalent
WARRANTY, SERVICE, AND REPAIR
WARRANTY
Except as otherwise expressly stated in the Agreement: i) Equipment
manufactured by Hologic is warranted to the original Customer to perform
substantially in accordance with published product specifications for one
(1) year starting from the date of shipment, or if Installation is required,
from the date of Installation ("Warranty Period"); ii) digital imaging
mammography x-ray tubes are warranted for twenty-four (24) months,
during which the x-ray tubes are fully warranted for the first twelve (12)
months and are warranted on a straight-line prorated basis during months
13-24; iii) replacement parts and remanufactured items are warranted for
the remainder of the Warranty Period or ninety (90) days from shipment,
whichever is longer; iv) consumable Supplies are warranted to conform to
published specifications for a period ending on the expiration date shown
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