Boston Scientific EndoChoice HedgeHog User manual

50736125-01
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eDFU, MB, HedgeHog Cleaning Brushes, en, 50736125-01A
Black (K) ∆E ≤5.0
INTENDED USE
For use in endoscope channel, valve, or control head cleaning.
Channel cleaning brushes provide mechanical scrubbing
to remove debris from biopsy and suction channels. Valve
brushes remove debris from the valves, valve openings and
dials of the endoscope control head.
WARNINGS AND PRECAUTIONS
Do not use as a cytology brush.
Use channel brushes only in channels 2.0 mm and larger.
Review endoscope manufacturer’s care and cleaning guidelines
prior to use of brushes.
Endoscope channels may be damaged if brushes are forced
through when channels are occluded or if resistance is met
during brush passage. If sharp bends in the plastic sheath or
wire cable are observed during insertion, dispose of brush to
avoid damaging the endoscope.
Do Not Reuse:
• Mechanical integrity may be compromised by reuse.
• Cross contamination may occur between endoscopes
if reused.
• Do not reprocess or resterilize. Brushes are not designed
for sterilization or disinfection after use.
Any institution, practitioner, or third party who reprocesses,
refurbishes, remanufactures, resterilizes, and/or reuses these
disposable devices must bear full responsibility for their safety
and effectiveness.
DIRECTIONS FOR USE:
Inspect the brush head before use for any loose or missing
bristles and check the catheter of the brush to ensure that there
are no cuts, kinks, or other issues which could compromise the
catheter strength.
For Channel Brushes: Using the cleaning media of
choice, advance the cleaning brush through the entire
length of the endoscope. Once the head of the channel
brush is visible after passing through the channel,
inspect for debris. Repeat, as necessary, until bristles
are clean.
For Valve Brushes: Remove valve(s) from the control
head of the endoscope. Using the cleaning media of
choice, use the brush to gently cleanse the valves,
valve openings, control head and control head dials.
Avoid twisting or torqueing the brush handle.
PRODUCT DISPOSAL:
After use, this product may be a potential biohazard. Handle
and dispose of in accordance with accepted medical practice
and applicable local, state and federal laws and regulations.
HedgeHog®
Cleaning Brushes
2018-10
<en >
EndoChoice®

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eDFU, MB, HedgeHog Cleaning Brushes, en, 50736125-01A
Black (K) ∆E ≤5.0
REF
Catalog Number
EC REP EU Authorized Representative
Consult instructions for use.
Legal Manufacturer
LOT
Lot
Use By
For single use only. Do not reuse.
EU Authorized
Representative
Atlantico Systems, Ltd.
34 Oldfield, Kingston
Galway
IRELAND
EC REP
Legal
Manufacturer
EndoChoice, Inc.
11810 Wills Rd
Alpharetta, GA 30009
USA
Recyclable
Package
© 2018 Boston Scientific Corporation or its affiliates.
All rights reserved.
Do not use if package
is damaged.
Date of Manufacture
NON
STERILE
Non-Sterile
CAUTION
Keep Away from Sunlight
STERILE EO
Sterilized using ethylene oxide.
WL Working Length
Keep Dry
24
Discard After Indicated Time
hrs
Quantity
Protect from heat and radioactive sources
Health Hazard
Diameter
Federal (USA) Law restricts this device to sale by
or on the order of a physician