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US endoscopy DuoSwift Instrucciones De Uso página 2

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  • MEXICANO, página 10
These products have been manufactured not to include latex.
• Product #00711618: The DuoSwift™ cleaning brush- channel brush & squeegee combo is to only be used in channels 2.8 –
7.0 mm in diameter.
• Product #00711619: The DuoSwift™ cleaning brush (channel brush & squeegee combo) & valve/control head brush.
The DuoSwift™ cleaning brush (channel brush & squeegee combo) is to only be used in channels 2.8 – 7.0 mm in diameter.
The valve/control head brush is to only be used in control head valve openings, the accessory/instrument channel and port.
Intended Use:
The single use DuoSwift™ cleaning brush is a combination cleaning brush. The flexible plastic sheath has a tapered nylon brush on
the leading end and a series of squeegees on the trailing end designed to safely remove debris from flexible endoscopes.
The single use valve/control head cleaning brush is intended to safely remove debris from the valve openings and dials of the control
head of flexible endoscopes.
Warnings and Precautions:
• Review Original Equipment Manufacturer's guidelines regarding the care and cleaning of individual endoscope channels prior to the
use of any cleaning brush.
• Follow universal precautions, use appropriate infection control principles, and wear appropriate PPE.
• The DuoSwift™ cleaning brush is to be used to clean channels 2.8 – 7.0 mm in diameter only.
• Do not use the DuoSwift™ cleaning brush in channels smaller than 2.8mm.
• Always use the DuoSwift™ cleaning brush in a wetted scope.
• Do not use the DuoSwift™ cleaning brush in channels in which there is a known retained foreign object (i.e. removed stents,
band ligators, other devices, etc.)
• The DuoSwift™ cleaning brush should never be used as a cytology brush.
• Never insert the squeegee portion of the DuoSwift™ cleaning brush first (as the leading end) as it will get stuck within the
channel.
• Dispose of the DuoSwift™ cleaning brush after each endoscope is cleaned. The mechanical attachment of the brush and squeegee
to the plastic sheath cannot be guaranteed to be reliable or secure following one complete endoscope cleaning.
• If sharp bends in the plastic sheath or wire cable are observed during insertion of the brush, the brush should be disposed of to avoid
causing damage to the endoscope's operating channels.
• Never transfer a used cleaning brush from one endoscope to another endoscope, since cross-contamination could occur and result
in patient complications. Disposable cleaning brushes are designed to safely remove debris, some of which can be retained in the
bristle structure.
• The DuoSwift™ cleaning brush is intended to clean the suction and accessory channels of flexible endoscopes. If the flexible
endoscope contains an elevator section, clean and brush the elevator and surrounding area according to manufacturer's
guidelines.
• US Endoscopy did not design these devices to be reprocessed or reused, and therefore cannot verify that reprocessing can clean
and/or sterilize or maintain the structural integrity of these devices to ensure patient and/or user safety.
• These disposable medical devices are not intended for reuse. Any institution, practitioner, or third party, who reprocesses, refurbishes,
remanufactures, resterilizes, and or reuses these disposable medical devices must bear full responsibility for their safety and
effectiveness.
Contraindications:
• A channel that is smaller than 2.8mm in diameter.
• A channel that is known to be occluded.
• Resistance is met in attempting to pass the brush through the endoscope.
Directions for Use:
1.
Prior to clinical use, open up package and remove device.
2.
Familiarize yourself with the device(s) and read all the Instructions for Use.
3.
Inspect the package and device for shipping or handling damage, i.e. bent or cracked catheter, missing bristles, brush, or
squeegee. If damage is evident DO NOT USE THESE DEVICES, SAVE THEM FOR RETURN, AND CONTACT YOUR LOCAL
PRODUCT SPECIALIST.
Always use the DuoSwift™ cleaning brush in a wetted scope.
4.
DuoSwift™ cleaning brush (Figure 1.):
5.
a.
Remove valves from the control head of the endoscope.
b.
Immerse entire endoscope in an appropriately prepared amount of detergent solution.
*
If cleaning an endoscope with an elevator, brush the elevator and surrounding area according to manufacturer's
guidelines.
c.
Remove all debris from the brush head.
Never insert the squeegee portion of the DuoSwift™ cleaning brush as the leading end as it will get stuck within the
d.
channel.
Insert the channel brush (leading end) of the DuoSwift™ cleaning brush into the suction cylinder and down the
e.
accessory/instrument channel of the insertion tube of the endoscope using short strokes until the channel brush is
visibly a few inches outside the distal end.
00732032Rev.E
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0071161800711619