Solero Directions for Use Rev B Jan 2019

TABLE OF CONTENTS WARNING...3 DEVICE DESCRIPTION...3 Figure 1...3 INTENDED USE/INDICATIONS FOR USE...3 CONTRAINDICATIONS...3 WARNINGS...4 PRECAUTIONS...4 HOW SUPPLIED...4 AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

EQUIPMENT LIST (TO PERFORM PROCEDURE):...4 OPERATIONAL INSTRUCTIONS...4 Testing the Device ...5 Placing the Device ...5 Performing an Ablation...5 Track Ablation ...6 Ending the Procedure/Disposal ...6 Examples of Ablation Zone Size Achieved in Ex-Vivo Tissue at 37°C...6 Figure 2. ...6 WARRANTY...7

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Solero

Microwave Tissue Ablation Applicator ONLY Caution: Federal Law (USA) restricts this device to sale by or use under the order of physician. WARNING

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. DEVICE DESCRIPTION The Solero* Microwave Tissue Ablation (MTA) Applicator consists of an internally cooled insulated shaft with a temperature sensor on the distal end. The Solero Applicator is designed to fit in a CT gantry and is available in 14 cm, 19 cm, and 29 cm lengths. It has an integrated microwave cable and tubing set. The device is comprised of: 1. 1.8 mm diameter (15 g) stainless steel shaft with depth markers 2. Ceramic tip microwave array. 3. Integrated multifunction cartridge for microwave and data connections. 4. 2 lumen (2 way) bag spike and tubing for coolant flow.

Figure 1. INTENDED USE/INDICATIONS FOR USE The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue* during open, laparoscopic, or percutaneous procedures. The Solero MTA System is not intended for cardiac use. *Note Canada Only: Throughout this document any reference to “soft tissue” means the following tissue types: Liver, Kidney, and Lung (early stage non-small cell lung cancer (NSCLC) and inoperable pulmonary malignancies). CONTRAINDICATIONS The applicators are contraindicated in patients with heart pacemakers and other electronic device implants.

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AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.

WARNINGS • If the Tubing Set becomes occluded, improper or unpredictable lesion size may occur. • Do not attach anything (i.e., clamps, etc.) to the device. This may damage the insulation, which could contribute to patient injury. • Reuse of single-use devices creates a potential risk of patient or user infections. • Contamination of the device may lead to injury, illness or death of the patient. • Reprocessing may compromise the integrity of the device and / or lead to device failure. • This device should not be used in conjunction with MRI image guidance as the device has not been tested for MRI compatibility. PRECAUTIONS • Avoid placing lateral forces on the applicator tip during placement or removal. AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

• Do not use the applicators if the expiration date provided on the packaging has expired, or the seal is broken. • Use only chilled sterile saline solution for the coolant reservoir. • Do not defibrillate a patient with an applicator inserted. Completely remove the applicator from the patient before defibrillation. • Use caution when treating close to critical structures. The ablation zone will grow beyond the applicator tip. Microwave energy is deposited 2 cm around the emitting tip of the device. Structures to be spared should be at least 2 cm away from the emitting antennae. • Always use the lowest power and shortest time necessary to achieve the targeted ablation. • Each applicator may be used to ablate up to three separate areas of target tissue for each patient at the maximum power and time setting. • Inspect the applicator after each ablation. If the applicator appears damaged, utilize another applicator for subsequent ablations. WARNING: Do not bend the applicator as this may impair the function of the cooling system and may damage the microwave feed line inside the applicator. WARNING: When using percutaneously the tip of the antenna may be used to puncture the skin at the point of insertion. Use the minimum force necessary to achieve this and take care not to over advance the applicator. Refer to the shaft depth markings to monitor placement depth. Take care to not bend the tip as it may cause damage to the device. • If used laparoscopically the device can be placed directly through the abdomen. It is not recommended to place the device through a laparoscopic port as this may result in a loss of abdominal insufflation. • Do not energize the applicator unless the active region of the applicator is fully inserted into target tissue. If the applicator is not properly located into the selected tissue, an unintended thermal injury may occur. WARNING: After each ablation inspect the applicator for any damage. If any damage is observed the applicator should be discarded and replaced with a new applicator. WARNING: Do not initiate the procedure/anesthesia until the applicator has been connected, primed, and the generator status bar indicates “Ready.” • Be careful when handling applicators, since rough handling may change the directional characteristics of the applicator. HOW SUPPLIED The Solero MTA Applicator is supplied STERILE using an ethylene oxide (EO) process. Store in a cool, dry place. Do not use if package is opened or damaged. Do not use if the applicator is damaged . Do not use if labeling is incomplete or illegible. EQUIPMENT LIST (TO PERFORM PROCEDURE): • Solero Generator • Chilled Sterile Saline (at least 1000 mL required) • Footswitch (optional) OPERATIONAL INSTRUCTIONS The following is the recommended procedure for operating the Solero Applicator. 1. Refer to the Solero Generator System Operator’s Manual and become familiar with operation of the generator. Refer to the instructions for use accompanying each product. 2. Turn on the Solero Generator. The generator will run through a self-test. Ensure the generator successfully completes self-test and advances to the Standby screen prior proceeding. 4

3. Inspect all devices and packaging for damage prior to use. Do not use any devices that are damaged or if the sterile barrier is breached. Do not use the Solero Generator if it has been dropped or damaged. 4. Using sterile technique, open the Solero Applicator packaging and carefully remove the device. Remove and dispose of all packaging materials. 5. Inspect the Solero Applicator’s pre-attached tubing sets prior to use. Do not use the device if the tubing sets have any evidence of damage (e.g. kinks, cracks, etc.). 6. Connect the Solero Applicator’s cartridge to the Solero Generator’s connection. Verify that the pins of the connector and plug are not bent before continuing. CAUTION: The cartridge connections can only mate to the generator in one direction. Therefore, attaching the cartridge to the Solero Generator requires minimal force. If force is required, the cartridge may be incorrectly aligned with the generator or the pins may be damaged. 7. Obtain a minimum of 1000 mL of sterile chilled saline. 3000 mL chilled saline may also be used to increase the amount of time before the cooling reservoir needs to be replaced. 9. To attach the single use tubing to a chilled-fluid delivery and collection system, remove the cap on tubing set spike and insert spike in the saline source, being careful not to puncture through the saline source. To ensure proper fluid movement hang the saline source higher than the generator (such as on an IV pole). 10. Load the tubing set into the Solero Generator pump. The pump clip on tubing should be loaded into the pump clip holder on the left side of the pump and then close the pump housing cover.

Pump Housing Cover

Pump Clip on Tubing Pump Clip Holder 11. Prime the tubing set by turning the pump on and making sure there are no air bubbles present in the tubing set and in the saline bag prior to placing the device in the target tissue. 12. Adjust the generator settings to achieve the desired ablation zone. Using the following charts as a general guide, adjust the generator settings to achieve the desired ablation zone. Refer to the Solero Generator System Operator’s Manual for specific instructions on how to adjust the settings. Please note ablation volumes in the charts are ex vivo tissues. Ablation volumes in fluid dynamic tissues may differ from those noted. Testing the Device 13. Prior to placing the device in the target tissue for ablation, place the tip of the device (including the black shaded zone of the shaft) in a container of sterile water or saline and activate the device at 100 watts for 10 seconds to ensure that the system is functional. Placing the Device 14. Using image guidance (e.g. ultrasound, CT) place the device into the target tissue. The junction of the ceramic tip to stainless steel shaft should be placed at the center of the lesion. Using the shaft markings on the applicator can assist in placement of the device. 15. The black shaded area on the shaft should be fully inserted into the tissue. 16. Verify the position of the device with imaging (e.g. ultrasound, CT). Performing an Ablation 17. Using either the optional footswitch or the Microwave Power Button on the upper right side of the front panel, start the application of the MW energy. The timer graphic located on the left of the display will begin to count down to zero as soon as the energy is activated. The delivered power will be displayed to the right of the timer graphic. CAUTION: The Output power display may decrease over time as reflected energy can increase over ablation period due to changes in the tissue. 18. The ablation is considered complete when the timer reaches zero. The ablation can be terminated by the user at any time using the Microwave Power Button or an optional footswitch. 5

AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

8. Sterile fluid should be chilled prior to procedure.

Track Ablation 19. If desired, Track Ablation can be performed during removal of the applicator (generator defaults to 100 W, and the time may be set from 0:00 to 1:30 in 5 second increments). a. Using the depth markers, slowly withdraw the applicator one centimeter at a time, allowing the applicator to evenly ablate the needle path. b. Microwave energy delivery will terminate automatically after the set time has elapsed. Pressing the Microwave Power Button (or optional footswitch) again will also terminate energy delivery. c. Take care to stop energy delivery once the applicator reaches the minimum insertion depth. Ending the Procedure/Disposal 20. The system will display an “Ablation Complete” message in the dialogue box when the timer reaches zero. 21. Once the applicator is removed from the patient, disconnect it from the generator and saline source. Dispose of the Solero applicator according to state and hospital policies pertaining to sharps and biohazard handling procedures. AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

Examples of Ablation Zone Size Achieved in Ex-Vivo Tissue at 37°C The figure illustrates the ablation zone dimensions. “A” is the ablation diameter (Ø) perpendicular to the applicator. “B” is the ablation length in the plane of the applicator as shown in the figure below. Ablation size may vary in clinical settings. All sizes are presented as diameter by length in centimeters (A Ø x B cm).

B

A

Figure 2. Liver

2 min (A x B)

4 min (A x B)

6 min (A x B)

60 W

2.4 Ø x 2.8 cm

3.0 Ø x 3.6 cm

3.5 Ø x 3.9 cm

100 W

3.0 Ø x 3.7 cm

3.5 Ø x 4.4 cm

4.2 Ø x 4.9 cm

140 W

3.2 Ø x 4.0 cm

4.0 Ø x 5.0 cm

4.4 Ø x 5.4 cm

2 min (A x B)

4 min (A x B)

6 min (A x B)

Kidney

60 W

2.4 Ø x 3.1 cm

3.0 Ø x 3.8 cm

3.2 Ø x 4.0 cm

100 W

2.6 Ø x 3.7 cm

3.4 Ø x 4.5 cm

3.5 Ø x 5.0 cm

140 W

2.9 Ø x 4.3 cm

3.5 Ø x 5.0 cm

3.9 Ø x 5.6 cm

2 min (A x B)

4 min (A x B)

6 min (A x B)

60 W

1.3 Ø x 1.9 cm

1.5 Ø x 2.1 cm

1.6 Ø x 2.4 cm

100 W

1.6 Ø x 2.7 cm

2.0 Ø x 3.2 cm

2.3 Ø x 3.2 cm

140 W

1.7 Ø x 3.2 cm

2.5 Ø x 3.6 cm

2.6 Ø x 3.6 cm

Lung

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WARRANTY AngioDynamics, Inc. warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond AngioDynamics control directly affect the instrument and the results obtained from its use. AngioDynamics obligation under this warranty is limited to the repair or replacement of this instrument and AngioDynamics shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this instrument. AngioDynamics neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. AngioDynamics assumes no liability with respect to instruments reused, reprocessed, resterilized, modified or altered in anyway and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.

AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

* AngioDynamics, the AngioDynamics logo and Solero are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary.

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AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

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AngioDynamics, Master Brand DFU Template 5.5 in x 8.5 in, 146T01A4 Rev/Ver. B. DFU, Solero, 16600972-01B_Multilingual

AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 USA USA Customer Service 800-772-6446

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