Hologic Acessa ProVu - User Manual

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Acessa

ProVu System User’s Guide PL-01-0040

CO 20-131 Revision: C

USER

’S GUIDE

Release Date: 2/5/2021

Main Page

Table of Contents2
Introduction4
Indications for Use4
Device Description and Components4
Contraindications6
Warnings6
General Warnings6
Environmental and EMI Warnings7
Use8
System8
Warnings Specific to Uterine Fibroid8
Ablation8
Precautions9
General Precautions9
Environmental and EMI Precautions9
Precautions During Electrosurgical Device9
Use9
Precautions Specific to the Acessa Provu System9
Precautions Concerning Acessa Provu9
System Guidance Accuracy9
Precautions Specific to Uterine Fibroid Ablation9
Sterilization and Safety Checks10
Switches, Buttons, Connections, and 13.7. Display10
Front Panel10
Buttons, Connections and Display10
Rear Panel11
Switches and Connections11
Setting up the Acessa Provu System12
Connecting System Components12
Before Patient Arrives12
Patient Preparation12
Energizing the System13
Use of the Acessa System13
Getting Ready13
Accessory Connections14
User Interface15
Menu Setttings16
Ultrasound Settings16
Expected Ablation Size16
Deployment, Ablation and Coag16
Pad Temperatures17
The Acessa Provu Guidance System Feature17
Procedure Planning19
Performing an Ablation19
Operation of System During Coag20
After the Procedure20
Shutting down the System20
Special Considerations: General Ablation Procedures21
Highly Vascularized Tissue21
One or more Electrode Arrays in a Duct or Vessel21
Ablation of Dense or Calcified Fibroid Tissue21
Ex-Vivo Studies21
Representative Ablation Shape Per Deployment21
Results from Ex-Vivo Bovine Liver Studies22
Representative Ablation Sizes in Ex-Vivo Bovine Liver with Settings in Temperature Control22
Clinical Studies - Fibroids22
Study Design23
Study Objectives23
Primary Objectives23
Secondary Objectives23
Inclusion and Exclusion Criteria23
Study Demographics23
Fibroid Symptoms and Characteristics Reported at Baseline - All Subjects24
Treatment24
Results of the Pivotal Study25
Safety25
Efficacy26
Surgical Reintervention Rate26
Uterine and Fibroid Volume26
UFS-QOL Scores27
EQ-5D Health State Score28
Overall Treatment Effect (OTE) Survey28
Data Regarding Return to Work and Return to Normal Activities28
Data Regarding Pregnancy28
Data Regarding Calcified Fibroids28
Therapeutic Medications at 24 and28
Months Post-Treatment28
Postmarket Surveillance Study - TRUST (Treatment Results of Uterine Sparing Technologies)29
Summary of the Post-Approval Study Methods29
Study Objective29
Study Design29
Study Population29
Data Source29
Key Study Endpoints29
Primary Endpoint29
Secondary Endpoint29
Total Number of Enrolled Study Sites29
Results30
Final Safety Findings (Key Endpoints)30
Study Strengths and Weaknesses31
Potential Risks of Acessa Provu System31
Patient Counseling32
Care and Maintenance32
Software Upgrades and Installation32
Maintenance32
Cleaning and Disinfecting the Console32
Calibration Verification32
Specifications32
System Specifications32
Guidance and Manufacturer's Declaration33
Technical Characteristics36
Compliance to Safety and Performance Standards37
Trouble Shooting37
Faults, Alerts, and Errors37
Fault/Alert Code Table37
Glossary of Symbols and Product Graphics40
Symbols40
Product Graphics Glossary41
Warranty Statement42

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Hologic Acessa ProVu Specifications

General

Brand	Hologic
Model	Acessa ProVu
Category	Medical Equipment
Language	English

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