Solero Microwave Tissue Ablation User manual

QUICK REFERENCE GUIDE†
Ablation zone diameter (A) and length (B)
INDICATION 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.
SETUP
1. Attach the power cable into the back of the Solero Generator.
2. Plug the generator into an electrical outlet.
3. Turn the generator power switch on (located on the back).
4. Connect the Solero Applicator’s cartridge to the generator’s connection.
5. Spike the applicator tubing into a chilled saline bag (1-3 L) and place the bag
above the system with an IV pole.
6. Load the applicator tubing set into the generator pump and pump clip holder.
7. Press the pump button to start the pump.
8. Test the applicator tip at 100 W for 10 seconds with sterile water or saline to
ensure device is functional.
DEVICE PLACEMENT
A
B
1. Using image guidance such as ultrasound or CT, determine the target location
for the ablation.
2. Insert the applicator using the clinician’s preferred method.
3. Place the transition of the stainless steel shaft and the ceramic tip at the center
of the intended area of the ablation.
»When using CT guidance, the transition will show up as a black band in
bone windows.
»When using ultrasound, the emitting antenna is 1.7 cm from the tip
of the device.
4. Make sure that the black shaded area on the shaft of the device is fully inserted
into the tissue.
‡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).
EQUIPMENT
• Solero Generator
• Solero Applicator
• Power cable
• Footswitch (optional)
• Chilled sterile saline (1-3 L)
• IV pole

USA >14 Plaza Drive, Latham, NY 12110 >tel: [phone] or 518-798-1215 >fax: [phone]
International >Haaksbergweg 75 (Margriettoren), 1101 BR, Amsterdam Z-O >The Netherlands >
tel: [phone] >fax: [phone]
www.angiodynamics.com
*AngioDynamics, the AngioDynamics logo, Solero and the Solero logo are trademarks and/or registered trademarks of AngioDynamics,
Inc., an affiliate or a subsidiary. © 2018 AngioDynamics, Inc. ANGC 328 INT Rev 02 01/18
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)
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
PERFORMING THE ABLATION
EX VIVO BOVINE LIVER
EX VIVO PORCINE KIDNEY
EX VIVO PORCINE LUNG
1. Set the desired ablation power and time using the up and down arrows.
2. Start the ablation by pressing the Microwave Power Button or the footswitch.
3. The timer will begin to countdown to zero as soon as the energy is
activated; the delivered power will be displayed to the right of the timer.
4. When the timer reaches zero, the ablation is considered complete.
Alternatively, the user may stop the ablation at any time using the
Microwave Power Button or the footswitch.
ENDING THE PROCEDURE
1. The system will display a window that states “Ablation Complete” when the timer reaches zero.
2. The user may press the “Track” button after the ablation to perform a track ablation as required by the clinician’s preference.
3. Once the device is removed from the patient, disconnect the device from the generator and saline source.
4. Dispose of the applicator according to state and hospital policies regarding sharps and biohazard handling procedures.
TROUBLESHOOTING
1. On-screen instructions for failure modes are displayed as pop-up menus or in the top right corner of the screen.
Follow the on-screen instructions for use when they arise.
»Orange faults are associated with recoverable warnings and the ablation can be restarted/continued.
»Yellow faults end the ablation and require that the entire system be rebooted.
2. If rebooting does not clear the fault, contact your AngioDynamics representative.
Note: Ablation volumes in perfused tissues may differ from static laboratory results.
Consult your AngioDynamics representative for country specific product availability.
Not intended for distribution in the USA.
†Please refer to the Solero Generator Operator’s Manual and the Solero Applicator Directions For Use for complete instructions, warnings,
and precautions.