Merit Medical SCOUT Instrucciones De Uso página 3

STERRAD System
STERRAD NX
STERRAD 100NX
Testing was performed in accordance with AAMI TIR No.12-2010 guidelines, "Designing, Testing
and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for
Device Manufacturers."
Please refer to the STERRAD System User's Guides for general reprocessing instructions,
including proper cleaning, and drying, and packaging information prior to reprocessing any
medical device in a STERRAD System.
RECOMMENDED PROCEDURE
SETUP INSTRUCTIONS
• Prepare the SCOUT Console for use (see details in Operation
Manual).
• Connect the SCOUT Multiple-use Handpiece to the Console,
ensuring that the
white dots align and are facing upwards.
• Turn on the SCOUT Console and activate the Handpiece (see details
in the
Operation Manual supplied with the Console).
TESTING THE HANDPIECE
• Place the distal end of the Handpiece on the target of the Handpiece
Test Card.
• If the audible indicator sounds, then the Handpiece is ready for use.
• If the audible indicator does not sound, replace the Handpiece and
test
(see Operation Manual for additional troubleshooting steps).
USING THE HANDPIECE
• Insert the Multiple-use Handpiece into the sterile sheath.
Note: SCOUT® Guide Sheath SH-01 has been tested for compatibility with the SCOUT Guide.
• Apply the sheathed Handpiece tip to skin or soft tissue.
• Ensure that no air gaps are present between the Handpiece tip and tissue.
• When the Handpiece detects the Reflector, the Console will emit an audible feedback that
increases in cadence. In addition, the numerical display on the Console will adjust as the
Handpiece is placed closer to the Reflector.
• After completion of procedure, remove the Multiple-use Handpiece from the sheath, dispose
of sheath.
REMOVING THE HANDPIECE
• Once the procedure is complete, shut down the Console (reference the Operation Manual for
instructions).
• Remove the Handpiece by pulling the connector straight out of the Console while holding the
Console still.
• Clean and Disinfect the Multiple-use Handpiece and store with SCOUT Console.
NOTE
These instructions for the SCOUT Multiple-use Handpiece are NOT meant to define or suggest
any medical or surgical technique. The individual physician is responsible for the proper
procedure and techniques to be used with this product.
STORAGE
• Store at -20o to 60oC (-40o to 104oF), 10% to 95% relative humidity, non-condensing.
SYMBOL
Lot Number
Catalog Number
Do Not Use if Package is Damaged
Non-Sterile
Caution: Federal (USA) law restricts this device to sale by or on the order of a
physician
Caution: Consult accompanying documents
Medical Device
"For European Union (EU) States, this symbol indicates 'Not for general waste. ' Dispose of in
accordance with the waste electronic & electrical equipment (WEEE) directive. "
CaviWipes® is a registered trademark of Metrex Research LLC. Cidex® and STERRAD® are
registered trademarks of Johnson & Johnson, Inc. Nanosonics® and Trophon® are registered
trademarks of Nanosonics Limited.
Cycle
Standard
Standard
DESIGNATION