Sonata SystemPhysician & Staff

Training

Sonata System for Sonography-Guided Transcervical Fibroid Ablation

LS 04633-007, Rev A, Physician Training Module, DMR 05860

SYSTEM COMPONENTS

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The Sonata System Components

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IUUS Probe (reusable)SMARTTablet

RF Generator

System Cart

RFA Handpiece (single use)

Two (2) Dispersive Electrodes

Treatment Device

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SMART Tablet

• Ultrasound imaging capabilities

• Compatible with Intrauterine Ultrasound Imaging Probe

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SMART Guide “Setting Margins for Ablation in Real Time”

SMART Guide is a graphical overlay used for:

• Planning ablation

• Deploying Needles

• Preparing to activate RF energy

INTRAUTERINE ULTRASOUND

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Intrauterine Ultrasound (IUUS) Imaging

• Imaging from within the uterus

• IUUS Tip is within the endometrial cavity

Intrauterine Ultrasound Imaging

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IUUS Probe Tip

Myometrium Fibroid

Serosa

Fluid in Endometrial Cavity

ABLATION TARGETING

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Ablation Targeting

• Ablation Zone – red inner ellipse

– Encompass as much fibroid as possible

• Thermal Safety Border – green outer ellipse

Ablation Targeting

Thermal Safety Border can be positioned up to the serosa.

It should never cross the serosa.

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TREATMENT DEVICE CONTROLS

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Articulation Lever

NeedleElectrode

Sliders

AblationGuideKnob

Introducer Sliders

Treatment Device Controls

Treatment Device Controls

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ABLATION PROCEDURE

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Ablation Procedure –Treatment Device Insertion

• IUUS Tip is at 0°

• Dilate cervix to 27 Fr (9 mm)

• Insert Treatment Device through

cervix

• Fenestrated speculum may help

access

• Place tenaculum to provide

stability and aid insertion

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Survey the Uterus

• Infuse hypotonic fluid

• Slide tip to fundus

• Survey uterus

• Identify fibroids

• Plan treatment

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Essential Safety Step SMART Guide Position

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2

3 Perform Safety Rotations

Thermal Safety Border within the serosa

Align Introducer Tip “Click to Tip”

Essential Safety Step Click on Tip for Alignment

• Align Introducer Tip with Introducer Marker

• Place cursor on Introducer Tip and click 23

+ +1

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3 Perform Safety Rotations

Thermal Safety Border within the serosa

Align Introducer Tip “Click to Tip”

Repositioning

If Thermal Safety Border (green outer ellipse) crosses serosa:

• Reduce Ablation Zone depth or size

• Pull device back

• Change articulation angle

• Move hand/elbow up or down

• Recheck safety Rotation anytime the device is repositioned

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Essential Safety Key

Deploy Needle Electrodes

• Slide forward to physical stop

• Needle Indicators turn bold red when completely deployed

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Essential Safety Step -Final Safety Rotation

• Rotate in both directions

• Verify Thermal Safety Border (green outer ellipse) is within serosa in all planes

• If resized or repositioned, Retract Needle Electrodes and repeat safety rotations

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1

2

3 Perform Safety Rotations

Thermal Safety Border within the serosa

Align Introducer Tip “Click to Tip”

RF Generator Status – READY

When is clicked:• RF Status changes to • RF Generator is armed and ready for ablation to be initiated

– Ablation does not start until operator initiates RF energy

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Start Ablation

To start ablation:

• Operator steps once on Footswitch (Do not rest foot on it to prevent unintended stop)

OR

• Support Staff presses ON/OFF button on RF Generator (not sterile)

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RF Status – ACTIVE

RF is

• RF energy is delivered

• Temperature is displayed

• Energy heats to 221°F (105°C)

• Ablation Time is displayed

• Status bar indicates ablation progress

• Ablation size is displayed

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POST-PROCEDURE

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Post Ablation

• Ablation completes automatically

• RF Generator beeps

• Yellow arrows are displayed 36

Treatment Complete: Retract Controls 4-3-2-1

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Post Treatment Patient Counseling

Patients may experience:

• Continued bleeding symptoms for a few months following procedure before improvement

• Shedding of ablated tissue

• Expulsion of ablated fibroid (low occurrence) 39

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