Handpiece - Merit Medical SCOUT CHECK Mode D'emploi

HANDPIECE

I N S T R U C T I O N S F O R U S E
DESCRIPTION
The SCOUT® Check Console, SCOUT Check Handpiece and SCOUT® Reflector are accessories
to the SCOUT Surgical Guidance System. The SCOUT Check Handpiece is designed to be used
without a cover or sheath and the cleaning & disinfection procedures described have been
validated. The SCOUT Check Handpiece is designed to be used without a cover or sheath and
the cleaning and disinfection procedures described have been validated. The SCOUT Check
Console (available separately), provides control operations for verifying the functionality of the
SCOUT Reflector (available separately) within soft tissue or biopsy site.
The system employs micro-impulse radar and infrared (IR) light technology to detect
the presence of the SCOUT Reflector, which is placed into soft tissue or biopsy site prior to
the procedure. The SCOUT Check Console provides the micro-impulse Radar signal to the
Handpiece along with power for the infrared light source. The SCOUT Check Handpiece delivers
the micro-impulse Radar signal and IR light into the soft tissue or biopsy site and in turn receives
signals reflected back from the SCOUT Reflector. The SCOUT Console processes the reflected
Radar signals to provide the physician with an audible indication when the SCOUT Reflector is
detected.
INDICATIONS FOR USE
SCOUT Check
The SCOUT Check System is an accessory to the SCOUT System. The SCOUT Check Console is
intended to be used to confirm detection of the SCOUT Reflector subsequent to percutaneous
placement in Radiology.
CONTRAINDICATIONS
• Not intended for connection to any other device or equipment.
• Only for use with the SCOUT Check Console and SCOUT Reflector.
WARNINGS
• SCOUT Check Handpiece contains sensitive electronic components. Do not crush or subject
cable to tight bends.
• SCOUT Check Handpiece is designed for use only with the SCOUT Check Console and SCOUT
Reflector.
• SCOUT Check Handpiece operates by emitting infrared light from the distal end. Do not point
an active SCOUT Check Handpiece at eyes.
• Cross-contamination risk: SCOUT Check Handpieces with cracks, abrasions or tears may harbor
dangerous contaminants or tear protective sheaths used with the SCOUT Check Handpieces. Do
not use if there are any signs of damage.
• Electrical leakage risk: Non-hazardous voltage is present during normal handpiece use.
• If the patient has an internal or external active cardiac implant, contact the cardiac implant
manufacturer for instructions before using the SCOUT system. The micro-impulse radar signal
may interfere with the intended function of the cardiac implant.
• Do NOT use if the package is open or damaged.
CAUTIONS
• Federal law restricts this device to sale by or on the order of a physician (21 CFR §801.109(b)(1)).
• This product should only be used by a physician who is completely familiar with the indications,
contraindications, limitations, typical findings and possible side effects of Reflector placement.
• SCOUT Check Handpiece is shipped non-sterile and must not be sterilized.
• After use, this product may be a potential biohazard. Clean and disinfect following the
procedures described below.
• Handle in a manner that will prevent accidental contamination. Do not use a device that is
damaged.
• Handpiece is MR (Magnetic Resonance) Unsafe and should not be used in the MR environment.
• Only use the covers or sheaths recommended. Other covers or sheaths may impact the ability
of the handpiece to detect the Reflector.
SCOUT
The SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark
a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such
as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the
SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is
intended only for the non-imaging detection and localization of the SCOUT Reflector that has
been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
CLEANING AND DISINFECTION
HANDLING THE SCOUT Check HANDPIECE
•Avoid dropping, impact, or abrasion to SCOUT Check Handpieces. Careless handling can result
in damaged infrared lights, damaged internal circuitry, cracked housings, and cable or system
connector damage. Do not use SCOUT Check Handpieces with cracked or damaged housings,
shaft, strain relief or cable assemblies as these issues may increase cross-contamination risks
and compromise electrical safety features of the SCOUT Check Handpiece.
English •Use care to avoid excessive twisting, pulling, pinching or kinking of handpiece cable assemblies.
When transporting SCOUT Check Handpieces, maintain control of cables and system connectors
and use protective accessories if possible.
• Prevent introduction of foreign objects or moisture in the system connector assembly. Do not
apply excessive force on any component of the system connector.
• Do not allow prolonged exposure to excessive moisture or immersion of SCOUT Check
Handpieces in any liquid above the recommended level as stated in the user manual for your
system. Do not soak SCOUT Check Handpieces in any liquid for longer than the recommended
period of time as stated in the system user's manual or chemical manufacturer instructions for
use.
• Avoid rapid and extreme temperature changes as well as lengthy exposure to direct sunlight
or a strong ultraviolet light source.
SCOUT Check HANDPIECE INSPECTION
Before use, inspect the following areas of the SCOUT Check Handpiece:
• SCOUT Check Handpiece body including the shaft, handle: inspect for cracks, abrasions, or
evidence of impact.
• Strain relief and cable assembly: check for cracks, cuts, tears, abrasion, kinking or crushing.
• System connector: check for foreign objects, broken latches, or bent pins and shielding.
• Cable assembly: check for discoloration or inflexibility of the handpiece cable or strain-relief.
SCOUT Check HANDPIECE CLEANING
These generalized cleaning and low level disinfecting instructions are indicated for use with
SCOUT Check Handpieces. Cleaning is the removal of all visible soil or contaminants from the
SCOUT Check Handpiece. All SCOUT Check Handpieces must be cleaned after every use and is
an essential step before disinfection is attempted.
1. After every procedure, ensure that any obvious contaminants are completely wiped off the
SCOUT Check Handpiece.
2. Use a moistened soft cloth or wipe (CaviWipe) to remove any remaining contaminants or
gross debris that remain on the SCOUT Check Handpiece or cable. Do not re-use cloths or wipes.
Disinfectant wipes should be used in accordance with the manufacturer's instructions. Merit
Medical is not responsible for damage incurred during the cleaning process for products in
which no material compatibility evaluation has been conducted.
Note: CaviCide wipes have been tested for compatibility with the SCOUT Check handpiece.
3. For use as a low level disinfectant, use a second CaviWipe wipe to thoroughly wet the surface.
For best results the surface should remain visibly wet for 3 minutes at room temperature
(68°F/20°C)
4. Use a lint-free soft and clean dry cloth or wipe to thoroughly dry the SCOUT Check Handpiece
and cable.
Notes: Cleaning products other than those described in the previous section (CaviWipes)
should be as close to neutral PH as possible. Any, cleaning or disinfectant products containing
concentrations surfactants, methanol, ethanol, benzyl or methyl alcohol, bleach, methyl or ethyl
paraben, polyethylene glycol, mineral oil, lubricant oil, oil based lotions, acetone, ammonia,
anhydrous ammonia, iodine, iodine compounds, acids with 5PH or greater may damage or
discolor the SCOUT Check Handpiece. The use of any type of brush is not recommended as
bristles may damage the distal end of the SCOUT Check Handpiece. Ultrasonic cleaning is not
approved for SCOUT Check Handpieces.
Warning: Disinfectant wipes and topical spray products are not FDA-cleared, high-level
disinfectants. These products do not provide adequate protection should the SCOUT Check
Handpiece become cross-contaminated or in contact with unhealthy or non-intact skin.
RECOMMENDED PROCEDURE
SETUP INSTRUCTIONS
• Prepare the SCOUT Check Console for use (see details in SCOUT Check Console Operation
Manual).
• Connect the reusable SCOUT Check Handpiece to the Console, ensuring that the white dots
align and are facing upwards.
• Turn on the SCOUT Check Console and activate the SCOUT Check Handpiece (see details in the
Operation Manual supplied with the SCOUT Check Console).
TESTING THE HANDPIECE
• Place the distal end of the SCOUT Check Handpiece on the target of the Test Card.
• If the audible indicator sounds, then the SCOUT Check Handpiece is ready for use.
• If the audible indicator does not sound, replace the SCOUT Check Handpiece and test (see
Operation Manual for additional troubleshooting steps).