Sonata SystemPhysician & Staff
Training
Sonata System for Sonography-Guided Transcervical Fibroid Ablation
LS 04633-007, Rev A, Physician Training Module, DMR 05860
The Sonata System Components
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IUUS Probe (reusable)SMARTTablet
RF Generator
System Cart
RFA Handpiece (single use)
Two (2) Dispersive Electrodes
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 (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
• 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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Articulation Lever
NeedleElectrode
Sliders
AblationGuideKnob
Introducer Sliders
Treatment Device Controls
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
2
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 Ablation
• Ablation completes automatically
• RF Generator beeps
• Yellow arrows are displayed 36
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