GUIDE
I N S T R U C T I O N S F O R U S E
DESCRIPTION
TThe SCOUT® Console, SCOUT® Guide (Multiple-use Handpiece) and SCOUT® Reflector are
accessories to the SCOUT Surgical Guidance System. The SCOUT Multiple-use Guide is a non-
sterile medical device that, when used with the SCOUT Console (available separately), provides
control operations for detecting 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 of biopsy site prior to the
procedure. The SCOUT Console provides the Radar signal to the Handpiece along with power
for the infrared light source. The SCOUT Multiple-use Handpiece delivers the 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 and visual indication when the SCOUT Reflector is detected.
INDICATIONS FOR USE
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.
CONTRAINDICATIONS
• Not intended for connection to any other device or equipment. Only for use with the SCOUT
Console and SCOUT Reflector.
WARNINGS
• SCOUT Multiple-use Handpiece contains sensitive electronic components. Do not crush or
subject cable to tight bends.
• SCOUT Multiple-use Handpiece is designed for use only with the SCOUT Console and SCOUT
Reflector.
• Handpiece operates by emitting infrared light from the distal end of the Handpiece. Do not
point an active Handpiece at eyes.
• Cross-contamination risk: Handpieces with cracks, abrasions or tears may harbor dangerous
contaminants or tear protective sheaths used with the handpieces. Do not use handpieces with
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 Multiple-use Handpiece is shipped non-sterile.
• After use, this product may be a potential biohazard. Clean and disinfect following the
procedures described above.
• 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.
CLEANING AND DISINFECTION
HANDLING THE HANDPIECE
• Avoid dropping, impact, or abrasion to handpieces. Careless handling can result in damaged
infrared lights, damaged internal circuitry, cracked housings, and cable or system connector
damage. Do not use 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 handpiece.
• Use care to avoid excessive twisting, pulling, pinching or kinking of handpiece cable
assemblies. When transporting 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.
English
• Do not allow prolonged exposure to excessive moisture or immersion of handpieces in any
liquid above the recommended level as stated in the user manual for your system. Do not soak
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.
HANDPIECE INSPECTION
Before use, inspect the following areas of the handpiece:
• 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.
HANDPIECE CLEANING AND LOW LEVEL DISSINFECTING
These generalized cleaning instructions are indicated for use with SCOUT Multiple-use
Handpieces. Cleaning is the removal of all visible soil or contaminants from the handpiece.
All 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
handpiece.
2. Use a moistened soft cloth or wipe (CaviWipes®) to remove any remaining contaminants or
gross debris that remain on the 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: CaviWipes have been tested for compatibility with the SCOUT Multiple-use 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
(68oF/20oC)
4. Use a lint-free soft and clean dry cloth or wipe to thoroughly dry the 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 lower may
damage or discolor the handpiece. The use of any type of brush is not recommended as bristles
may damage the distal end of the handpiece. Ultrasonic cleaning is not approved for SCOUT
Multiple-use Handpieces.
Warning: Disinfectant wipes and topical spray products are not FDA-cleared, high-level
disinfectants. These products do not provide adequate protection should the handpiece
become cross-contaminated or in contact with unhealthy or non-intact skin.
HIGH LEVEL DISINFECTING
The following provides instructions for performing high level disinfection of SCOUT Multiple-
use Handpiece with Cidex® OPA.
1. Clean the handpiece and cable according to the procedures in the "Handpiece
Cleaning and Low Level Disinfecting" section.
2. Ensure minimum effective concentration (MEC) of the Cidex OPA using Cidex
OPA test strips.
3. Equilibrate a water bath of Cidex OPA to 20°C.
4. Immerse the handpiece into the Cidex OPA as shown in the image. Do not
immerse the connector, cable or cable strain relief. Ensure all air bubbles
are removed from the surface of the handpiece with a syringe filled with the
disinfectant to remove all air bubbles.
5. Allow the handpiece to soak for 12 minutes.
6. Thoroughly rinse the handpiece by immersing in pure water (PURW), agitating
and allowing to set for a minimum of 1 minute.
7. Repeat the previous step two more times for a total of 3 rinses using a fresh
batch of PURW each time.
8. Dry the handpiece using a sterile lint-free cloth.
The following provides instructions for performing high level disinfection of SCOUT Multiple-
use Handpiece with the Nanosonics® Trophon® EPR System.
1. Clean the handpiece and cable according to the procedures in the
"Handpiece Cleaning and Low Level Disinfecting" section.
2. Place the handpiece into the Trophon EPR as shown.
3. Follow the Trophon EPR manufacturer's instructions for performing the
standard cycle.
4. Remove the handpiece using minimal contact after the cycle is complete.
5. Dry the handpiece as necessary using a sterile lint-free cloth.
6. Visually inspect the handpiece and ensure any disinfectant residue
present is removed.
7. The handpiece is ready for use or storage.
STERILIZATION
The following provides instructions for performing sterilization of the SCOUT Multiple-Use
Handpiece with the Advanced Sterilization Products STERRAD System
The SCOUT Multiple-Use Handpiece has been validated for sterilization in the STERRAD 100S,
NX, 100NX System.
STERRAD System
STERRAD 100S
Cycle
Short