Hologic Myosure REACH 10-401FC Instrucciones De Uso página 9

Note:
If system is turned off for any reason, wait at
least 15 seconds before turning power back on.
CLEARING THE FIELD OF VIEW FOR
MYOSURE XL (50-501XL/50-503XL)
If visualization is lost, stop cutting immediately.
1.
Press the aspiration button located on the thumb
2.
rest (figure 11) to momentarily increase suction to
facilitate clearing the field of view.
Periodically press the aspiration button to clear the
3.
field of view as needed.
Figure 11. Aspiration Button to clear the field of view.
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 controller
(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.
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.
Disposal
Disconnect the tissue removal device from the
controller. Dispose of the tissue removal device and
packaging according to your facility's policies and
procedures concerning biohazardous materials and
sharps waste.
CAUTION:
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.
The tissue removal
MyoSure Tissue Removal System IFU
Troubleshooting
The MyoSure Tissue Removal System is very simple to
operate. The controller unit is switched ON using the
power switch. If the unit does not operate, check the
following:
The controller is plugged into wall outlet.
1.
Wall outlet has power.
2.
Power cord is attached to back of the controller.
3.
Foot pedal has been connected to the front panel of
4.
the controller.
Vacuum pressure is available for the controller.
5.
Suction tubing is connected.
6.
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. The control unit powers down
unexpectedly, leave it off for 15 seconds, restart the
system and follow on-screen prompts.
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:
10-401FC / 10-403FC
Sterile, single use device
Working Length: 12.6" / 32 cm
OD: 3 mm
30-401LITE / 403LITE
Sterile, single use device
Working Length: 12.6" / 32 cm
OD: 3 mm
50-501XL / 50-503XL
Sterile, single use device
Working Length: 12.6" / 32 cm
OD: 4 mm
50-601XL / 50-603XL
Sterile, single use device
Working Length: 12.6" / 32 cm
OD: 4 mm
The MyoSure Tissue Removal Device can be used with
a vacuum source (200-650 mm Hg). Examples include.
Aquilex™ Fluid Control or Olympus Vacuum pump
model kv-5 System 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.
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