Medovations CleanFreak 1200-01 User manual

Medovations CleanFreak® Endoscope Cleaning Brushes
Instructions for use and cleaning.
Read carefully prior to use.
Caution: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
102 E. Keefe Ave.
Milwaukee, WI 53212 USA
800.558.6408
414.265.7620
Fax [phone]
[e-mail]
www.medovations.com
063-0035W Rev. E, 2015/04

Medovations, Inc.
102 E. Keefe Ave.
Milwaukee, WI 53212 USA
800.558.6408
414.265.7620
Fax [phone]
[e-mail]
www.medovations.com
063-0035W Rev. E, 2015/04
MEDOVATIONS CLEANFREAK® ENDOSCOPE CLEANING BRUSHES
Directions for Use and Cleaning.
Read carefully prior to use.
INTENDED USE
The Endoscope Cleaning Brush(es) are used to safely remove debris from the channels,
valves, and dials of flexible endoscopes.
The channel cleaning brush has a brush attached to a flexible plastic sheath that is designed
to safely remove debris from the endoscope accessory/suction channel, the auxiliary water
channel, and/or the balloon inflation channel (EUS endoscope) of flexible endoscopes.
The control head cleaning brush is used to safely remove debris from the valve openings and
dials of the control head of flexible endoscopes.
Part #1200-01, #1200-03, #1200-04, Part #1200-07, #1200-08
Use only in channels 2.0mm and larger
Part #1200-02
Use only in channels 2.8mm and larger
Part #1200-05, #1200-09
Use only in channels 2.0mm and larger and in control head valve openings
Part #1200-06
Use only in control head valve openings
WARNINGS AND PRECAUTIONS
1. The cleaning brush must never be used as a cytology brush.
2. Original Equipment Endoscope Manufacturer’s guidelines for the care and cleaning of
the individual endoscope channels, valves, and dials must be reviewed prior to the use
of any cleaning brush.
3. The Cleaning Brushes are single use only and must be disposed of after use. This device
was not designed to be reused or reprocessed. The mechanical attachments of the
brushes to the plastic sheath and/or plastic handles are not designed to be secure for
more than a one (1) use. Any institution, practitioner, or third party who reprocesses,
refurbishes, remanufactures, resterilizes, and/or reuses this disposable device must
bear full responsibility for its safety and effectiveness. The materials used in the
manufacture of this device will not withstand repeated reprocessing. This device may
not perform as intended by the manufacturer if it is reused. This may lead to failure of
the device to perform as intended and/or material degradation.
4. Never transfer a used cleaning brush from one endoscope to another endoscope.
Debris can be retained in the bristles of the cleaning brushes and cause cross-
contamination. Cross-contamination could occur if a cleaning brush is transferred from
one endoscope to another, which could result in patient complications. The cleaning
brushes are single use only.
5. Avoid sharp bends of the plastic sheath and/or twisted wire of the brushes during
insertion. If sharp bends are noticed during insertion, the brush should be removed
immediately and disposed of to avoid causing damage to the endoscope’s operating
channels.
CONTRAINDICATIONS
1. If resistance is met in attempting to pass the brush through the endoscope, do not force
the cleaning brush through the endoscope, as this may result in damage to the channel.
Do not use the cleaning brushes if the channel(s) are known to be occluded as this may
result in damage to the channel.
2. Follow all cleaning instructions of the endoscope’s Original Equipment Manufacturer.
Do not use a specific cleaning brush in a specific cleaning channel if use is not
recommended by the endoscope’s manufacturer.
DIRECTIONS FOR USE
1. The cleaning brushes are provided single use only, non-sterile. Endoscope Cleaning
Brushes cannot be reused nor reprocessed.
2. Channel Cleaning Brush:
a. Using the cleaning media of choice, advance the cleaning brush through the entire
length of the endoscope before reversing direction. Reversing direction inside the
endoscope could cause the brush to expand, which could potentially damage the
endoscope channel.
b. Using the cleaning media of choice, pass the channel cleaning brush through the
valve stem openings.

Medovations, Inc.
102 E. Keefe Ave.
Milwaukee, WI 53212 USA
800.558.6408
414.265.7620
Fax [phone]
[e-mail]
www.medovations.com
063-0035W Rev. E, 2015/04
3. Control Head Cleaning Brush:
a. Remove the valve(s) from the control head of the endoscope. Use the brush and
the cleaning media of choice to gently cleanse the valve openings. Avoid twisting
or torquing the brush handle. The brush handle will prevent the brush from being
pushed too deeply into the valve openings.
b. Use the brush and the cleaning media of choice to clean the control head and the
control head dials.
PRODUCT DISPOSAL
After use, this product may be a potential biohazard. Handle and dispose of the product in
accordance with accepted medical practice and applicable local, state and federal laws and
regulations.
DESCRIPTION OF SYMBOLS USED ON LABELS
Non-Sterile Device
Caution, Consult Accompanying Documents
Do Not Re-Use
Do Not Use if Package is Damaged
Not Made with Natural Rubber Latex
Use By Date (YYYY-MM-DD)