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SURGICAL GUIDANCE SYSTEM
INTRODUCTION
Caution
• Read all warnings, cautions, and instructions provided with this Console before using.
• Read the instructions, warnings, and cautions provided with the SCOUT Guide, SCOUT
Handpiece, and SCOUT Reflector before using. Specific instructions are not included in
this manual.
• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Device Description
The SCOUT® Console, SCOUT Guide, SCOUT Handpiece, and SCOUT Reflector are components
of the SCOUT Surgical Guidance System. The SCOUT Console is a medical device that provides
control operations for detecting the presence of the SCOUT Reflector within soft tissue during
surgery. The SCOUT Handpiece and SCOUT Reflector are available separately.
The SCOUT® System employs micro-impulse radar and infrared light (IR) technology to
determine the location of the Reflector, which is placed into the soft tissue during a prior
procedure. The Console provides the micro-impulse radar signal to the Handpiece along
with power for the infrared light sources. The Handpiece delivers the micro-impulse radar
signal and infrared light into the soft tissue and in turn receives signals reflected back from
the Reflector. The Console processes the reflected radar signals to provide the surgeon with
Reflector proximity and location information via audible and visual feedback.
The numeric display provides real-time distance between the Handpiece and Reflector. The
audible feedback produced by the Console increases in cadence as Handpiece is placed in
closer proximity to the Reflector. The Console provides a maximum detection range of 60mm
from the Handpiece to the Reflector. Excision of the lesion is then performed using standard
surgical technique.
The Console and Guide are provided non-sterile. The Handpiece and Reflector (available
separately) are provided sterile.
INDICATIONS FOR USE
The SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a
biopsy site or a lumpectomy 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
• The SCOUT System is intended for use in the location of the SCOUT Reflector in soft tissue or
biopsy site. The SCOUT System is contraindicated for use in ocular, cardiac, neurological and
spinal clinical applications.
Compatible Components
The following items are required for the proper use of the SCOUT Console. Use of other parts
and materials not listed below is contraindicated.
• SCOUT Reflector
• SCOUT Handpiece (Disposable Handpiece)
• SCOUT Guide (Multi-Use Handpiece)
WARNINGS AND CAUTIONS
It is important that the instructions supplied with this Console be read, understood, and
followed.
Warnings
• Failure to thoroughly review and adhere to the information contained in this Operation Manual
may pose a potential hazard to the patient and/or user.
• Electric Shock Hazard – The Console must be properly grounded to ensure patient safety.
Do not connect the included power cord to extension cords or to power plug adapters. To
avoid the risk of electrical shock, this equipment must only be connected to supply mains with
protective earth.
• Electric Shock Hazard – No modification of this equipment is allowed. Do not remove the
cover. Removal of the cover may cause electrical shock. Contact Merit Medical for service.
• Electric Shock Hazard – Do not connect wet accessories to the Console.
• Electric Shock Hazard – Always turn off and unplug the Console before cleaning.
• Fire Hazard – Do not use extension cords.
• Explosion Hazard – This system is not designed for use in an explosive atmosphere.
• Never use any power adapter or cable other than the one specifically supplied with the
instrument.
• Check the instrument before use for signs of damage, particularly to cables. If the
instrument is damaged or gives unexpected performance or operation, then
cease using the device and ensure that it is serviced before recommencing use of
the device.
• 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.
Cautions
• Read all warnings, cautions, and instructions provided with this Console before using.
• Read the instructions, warnings, and cautions provided with the Handpiece and Reflector
before using. Specific instructions are not included in this manual.
• Federal law restricts this device to sale by or on the order of a physician.
• This equipment should only be used by a physician trained in its indicated use, limitations, and
possible complications of soft tissue surgery techniques.
• Inspect cords for breaks, cracks, nicks, or other damage before every use. If damaged, do not
use. Failure to observe this precaution may result in injury or electrical shock to the patient or
operator.
• Verify power cord is secure before each use.
• Always switch the instrument off at the mains power outlet, before inserting or removing the
power connector from the rear of the instrument. Failure to do so may damage the internal
instrument electronics.
• Do not leave the Console in LOCALIZATION Mode when not in use.
English
• Connect the power cord to a hospital grade wall outlet having the correct voltage or product
damage may result.
• Ensure cables are positioned to prevent trip hazards.
• For best results, operate the instrument in a stable (vibration-free) environment, with the
Console placed on a level working surface.
• Do not operate Console within 10 meters of another Console.
• Do not place Console in contact with other electrical equipment during use.
• The Console is non-sterile. Do not sterilize.
• Care should be taken not to drop the Console, or subject it to any form of rough physical
handling, either during normal use or during storage and transportation.
• Never clean the Console using an excessively wet cloth, or by washing it under running water.
• Do not clean the Console with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the unit.
• The Console, Handpiece/Cable Assembly, and the Delivery System of the SCOUT System are MR
Unsafe and should not be used in the MR environment
• The implanted SCOUT Reflector is MR Conditional.
• The use of Xenon light sources should be used with caution. Xenon light sources may contain
wavelengths of light that could affect the sensitivity of the system when the light is illuminating
the area of the reflector.
CONTROLS, INDICATORS AND RECEPTACLES
Instrument Description
The Console contains the controls. The controls are located on the front and back of the Console.
The Console produces signal outputs in the form of an audible pitch that represent the intensity
of the Handpiece's signal.
Front Panel
Rear Panel
CONSOLE SETUP AND OPERATION
Caution
• Read all warnings, cautions, and instructions provided with this Console before using.
• Read the instructions, warnings, and cautions provided with the Handpiece and Reflector
before using.
IMPORTANT
The SCOUT Console is intended for use by suitably qualified, trained and authorized physicians
and/or operating room staff. Merit Medical, Inc. takes no responsibility for the possible misuse
or use by inadequately qualified staff.
Setting up the Console
Warning
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• Electric Shock Hazard – Do not connect wet Handpiece cables to the Console.
• Fire Hazard – Do not use extension cords.
1. Verify the Console is off by pressing the power switch off ( O ).
2. Place the Console on a stable flat surface.
3. Plug the Console power cord into the rear panel receptacle.
4. Insert the power cord into a grounded power outlet.
5. Install the Handpiece as follows:
o The white dot on the Handpiece should be toward the top of the connector
o Align the Handpiece with the Handpiece receptacle on the console
o Push the Handpiece into the receptacle until fully seated.
NOTE: User must be able to hear the audible feedback provided by the Console for proper
operation. Ensure the speaker grill on the rear of Console is clear of obstruction. Ensure that
front panel is visible.
Operating the Console
6. Turn on the Console by pressing the power switch on ( | ). Verify the following:
o Display on the console lights up, shows the SCOUT logo.
o After several seconds,the display should show the message SYSTEM READY.
7. Activate the Handpiece by pressing the START/STOP button on the front panel of the Console.
Verify that the display shows LOCALIZATION MODE, indicating that the Console is ready to
operate.
8. Perform a Handpiece test by placing the distal end of the Handpiece near the self-test card
o If the test is successful, an audible indication sounds and display reads millimeter
measurement.
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