SCOUT CHECK Console Operation Manual May 2019

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Merit Medical Systems, Inc. 6 Journey, Suite 125 Aliso Viejo, CA 92656 USA

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TABLE OF CONTENTS

Table of Contents INTRODUCTION ... 4 Device Description ... 4 Indications for Use ... 4 Contraindications ... 5 Compatible Components ... 5 WARNINGS AND CAUTIONS ... 6 CONTROLS, INDICATORS AND RECEPTACLES ... 8 Instrument Description ... 8 CONSOLE SETUP AND OPERATION ... 9 Setting up the Console ... 9 Operating the Console ... 10 After Surgery ... 10 CLEANING ... 11 TROUBLESHOOTING ... 12 MAINTENANCE AND SERVICE ... 13 SYMBOLS ... 14 SPECIFICATIONS ... 16 EMC Statement... 17 Electromagnetic Compliance (EMC) Tables ... 18

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INTRODUCTION Caution • Read all warnings, cautions, and instructions provided with this Console before using. • Read the instructions, warnings, and cautions provided with the SCOUT Check 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® Check Console and SCOUT Check Handpiece, are accessories to the SCOUT Surgical Guidance System. The SCOUT Check Console is a medical device that provides control operations for verifying functionality of the SCOUT Reflector within soft tissue or biopsy site. The SCOUT Check Handpiece and SCOUT Reflector are available separately. The SCOUT® Check 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. The SCOUT Check Console and SCOUT Check Handpiece (available separately) are provided non-sterile. The SCOUT Reflector (available separately) is provided sterile.

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. 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.

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Contraindications • •

The SCOUT Check System is intended only for use in confirming the functionality of the SCOUT Reflector in soft tissue. The SCOUT Check System is contraindicated for use in ocular, cardiac, neurological and spinal clinical applications. Not intended for use in operating room environment.

Compatible Components The following items are required for the proper use of the SCOUT Check Console. Use of other parts and materials not listed below is contraindicated. • SCOUT Reflector • SCOUT Check Handpiece

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WARNINGS AND CAUTIONS It is important that the instructions supplied with this SCOUT Check 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 Detection Mode when not in use. • 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. 406025002_001 ID 05262019

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Do not operate SCOUT Check Console within 10 meters of another SCOUT Check 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, and the Delivery System of the SCOUT Check 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.

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CONTROLS, INDICATORS AND RECEPTACLES Instrument Description The SCOUT Check Console contains the controls. The controls are located on the front and back of the SCOUT Check Console. The SCOUT Check Console produces a signal output in the form of an audible tone that represent the presence of the Reflector. Front Panel

POWER LED

SYSTEM READY LED

DETECT MODE LED

Start/Stop Button Handpiece receptacle connector

Rear Panel

Power cord receptacle

Fuse Drawer

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Power on/off switch

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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 Check 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. 2. 3. 4. 5.

Verify the Console is off by pressing the power switch off ( O ). Place the Console on a stable flat surface. Plug the Console power cord into the rear panel receptacle. Insert the power cord into a grounded power outlet. 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.

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Operating the Console 6. Turn on the Console by pressing the power switch on ( | ). Verify the following: o The POWER LED lights up to indicate that the Power is on. o After several seconds, the SYSTEM READY LED should light up. 7. Activate the Handpiece by pressing the START/STOP button on the front panel of the Console. Verify that the DETECT MODE LED lights up, 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. o If the test is not successful, an audible indication does not sound. See ‘Troubleshooting’ section of this manual for appropriate steps. 9. Apply the Handpiece tip to skin. Ensure that no air gaps are present between the Handpiece tip and skin. o When the Handpiece detects the Reflector, the Console will emit a steady audible tone. NOTE: When not in use, place the Console in Standby mode by pressing the Start/Stop button. The SYSTEM READY LED will light. To return to DETECT MODE, perform Step 7 again.

After Surgery 10. Turn off the Console by pressing the power switch off ( O ). 11. Clean and disinfect the SCOUT Handpiece per the cleaning procedure provided with the Handpiece. 12. Unplug the power cord from the wall outlet.

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CLEANING Warning • Electric Shock Hazard – Always turn off and unplug the Console before cleaning. Notice • Do not clean the Console with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the console. 1. Turn off the Console, and unplug the power cord from the wall outlet. 2. Thoroughly wipe all surfaces of the Console, including handpiece receptacles, and power cord with a mild cleaning solution or disinfectant and a damp cloth. Follow universal, generally accepted practices when handling components that have come in contact with blood or tissue. Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the Console. The Console cannot be sterilized.

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TROUBLESHOOTING General Troubleshooting Guidelines If the Console malfunctions, check for conditions that may have caused the problem: • Check the Console for visible signs of physical damage. • Verify that the power cord is connected to the Console and power outlet. • Verify that the Handpiece cable is connected and attached properly. Use the table below to help identify and correct specific conditions. Situation Recommendation POWER LED does not • Verify that AC power cord is connected. illuminate • Verify that the AC power outlet is live. • Replace power cord. • Replace power fuse (replace with a T 1AL, 250V fuse). SYSTEM READY light does • Verify that the Handpiece is connected and attached properly. not illuminate steady • Turn the Console off, then on again. • Replace Handpiece. • If symptom persists, the Console may require service. Contact Merit Medical. No sound heard from • Verify that the console is in DETECT MODE. Console • Verify that the Handpiece is connected and attached properly. • Turn the Console off, then on again. • Replace Handpiece. • Use self-test card to check for system function. • If symptom persists, the Console may require service. Contact Merit Medical. DETECT MODE light does • Press START/STOP button. not illuminate • Turn the Console off, then on again. • If symptom persists, the Console may require service. Contact Merit Medical. Tone during nonuse of • Press START/STOP button, put system in SYSTEM READY. handpiece • Move handpiece away from other cables, devices. • Turn the Console off, then on again.

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MAINTENANCE AND SERVICE The SCOUT Check Console must be serviced by Merit Medical Inc. To ensure proper performance, the Console should be checked for any signs of damage or wear before each use and storage. This includes the housing, integrity of switches, and power cord. Should abnormalities be discovered by the user, the user should contact Merit Medical, Inc. Do not use a damaged Console. Preventative maintenance is limited to external cleaning of console, fuse replacement, and confirmation of power up functional diagnostics as described in this manual. The SCOUT Check console does not require any specific routine service. The Console contains no user serviceable parts and should not be opened by the user. Please contact Merit Medical for service. Merit Medical Systems, Inc. 6 Journey, Suite 125 Aliso Viejo, CA 92656 USA www.merit.com Caution • If a Console is to be shipped from your institution for repair, then please clean and disinfect the Console as described in this manual before packing for shipment. Indicate on the outside of the shipping container that the Console has been cleaned and disinfected.

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SYMBOLS The following are descriptions for the symbols shown on the rear panel of the Console. Symbol

Description Manufacturer of the device

Serial number Catalog Number

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Warning: risk of electric shock. No user serviceable parts inside.

General warning

See instructions for use

Identifies a type BF applied part

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SPECIFICATIONS Parameter Operating power Power consumption Audio volume Sound indicator Visual Indicators Instrument make / model Dimensions

Weight Operating ambient temperature range Operating relative humidity range Storage ambient temperature range Storage relative humidity range Shipping temperature: Shipping humidity: Storage and transit atmospheric pressure Operating altitude System Controls Interconnects Ingress of Fluids Flammability

Electrical Conformity

Electrical shock protection - Classification Electrical shock protection - Degree Product Life

Applied Part Separation from power mains

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Specification AC Line Power 120-240 VAC (50/60Hz) 26 watts, nominal 38 watts, maximum (at high volume) 70 dB Sound Pressure Level at 1 meter Fixed tone. LEDs Merit Medical Inc. / SCOUT Check Console 12 inches width 6 inches height 12 inches depth 6 lbs. 10°C to 30°C (50° to 86° F) 30% to 75%, non-condensing -20o to 60o C (-40o to 104o F) 10 percent to 95 percent relative humidity, noncondensing -40°C to 60°C (-40°F to 140°F) for 3 consecutive days. 10% to 95% RH, non-condensing, for 3 consecutive days. 500hPa to 1060 hPa (7.3 psia to 15.4 psia) Maximum of 2000m Buttons Custom cables Not protected against the ingress of fluid. IPX0 Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or with nitrous oxide This medical equipment has passed all required testing for electric shock, fire and mechanical hazards in accordance with UL60601-1, IEC/EN 60601-1 Class I Type BF Equipment The Console is a non-sterile, durable good. The product warranty is for a one-year time period consistent with use described in this manual. The Handpiece is the patient applied part Power switch on rear panel provides full separation from power mains

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EMC Statement Important information regarding Electromagnetic Compatibility (EMC) With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC 60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. The SCOUT Check System conforms to this IEC60601-1-2:2001 standard for both immunity and emissions. Nevertheless, special precautions need to be observed: •

The use of accessories and cables other than those specified by Merit Medical, may result in increased emission or decreased immunity of the device.

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The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.

Refer to further guidance below regarding the EMC environment in which the device should be used.

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Electromagnetic Compliance (EMC) Tables Guidance and manufacturer's declaration - electromagnetic emissions The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or user of the SCOUT Check System should assure that it is used in such an environment. Emissions test Electromagnetic environment Compliance guidance The SCOUT Check System uses very low power RF energy for its function. Therefore, its RF RF emissions Group 1 emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment. RF emissions The SCOUT Check System is Class A CISPR 11 suitable for use in all Harmonic emissions establishments other than Class A IEC 61000-3-2 domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: WARNING: This equipment/system is intended Voltage fluctuations/flicker for use by healthcare emissions Complies professionals only. This IEC 61000-3-2 equipment/system may cause radio interference or may disrupt operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the SCOUT Check system or shielding the location.

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Guidance and manufacturer's declaration - electromagnetic immunity The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or the user of the SCOUT Check System should assure that it is used in such an environment. Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level environment - guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, Discharge (ESD) concrete or ceramic tile. If floors are covered with IEC 61000-4-2 ±8 kV air ±8 kV air synthetic material, the relative humidity should be at least 30 %. Electrical fast ±2 kV for power supply ±2 kV for power Mains power quality should transient/burst lines supply lines be that of a typical commercial or hospital IEC 61000-4-4 ±1 kV for input/output ±1 kV for environment. input/output lines lines Surge

±1 kV line(s) to line(s)

±1 kV line(s) to line(s)

IEC 61000-4-5

±2 kV line(s) to earth

±2 kV line(s) to earth

Voltage dips, short <5 % UT interruptions and (>95 % dip in voltage variations on U ) for 0.5 cycle T power supply input lines. 40 % UT (60 % dip in UT) IEC 61000-4-11 for 5 cycles

<5 % UT (>95 % dip in UT) for 0.5 cycle

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec 3 A/m

<5 % UT (>95 % dip in UT) for 5 sec 3 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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40 % UT (60 % dip in UT) for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the SCOUT Check System requires continued operation during power mains interruptions, it is required that the SCOUT Check System be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer's declaration - electromagnetic immunity The SCOUT Check System is intended for use in the electromagnetic environment specified below. The customer or the user of the SCOUT Check System should assure that it is used in such an environment. *NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. IEC 60601 Test Compliance Immunity Test Electromagnetic environment - guidance Level Level Conducted RF 3 Vrms 3 V* Portable and mobile RF communication IEC 61000-4-6 150 kHz to 80 MHz equipment should be used no closer to any part of the SCOUT Check System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 𝑑 = 1.2√𝑃 Radiated RF 3 V/m 3 V/m* Recommended separation distance IEC 61000-4-3 80 MHz to 2.5 GHz 𝑑 = 1.2√𝑃 80 MHz to 800 MHz 𝑑 = 2.3√𝑃 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength from fixed RF transmitters as determined by an electromagnetic site survey (a) should be less than the compliance level in each frequency range (b) Interference may occur in the vicinity of equipment marked with the following symbol.

NOTE 1: At 80MHz and 800MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 406025002_001 ID 05262019