Hologic Acessa ProVu Manuals

Manuals and User Guides for Hologic Acessa ProVu. We have 1 Hologic Acessa ProVu manual available for free PDF download: User Manual

Hologic Acessa ProVu User Manual (42 pages)

Brand: Hologic | Category: Medical Equipment | Size: 2.5 MB

Table of Contents
2
Introduction
4
Indications for Use
4
Device Description and Components
4
Contraindications
6
Warnings
6
General Warnings
6
Environmental and EMI Warnings
7
Use
8
System
8
Warnings Specific to Uterine Fibroid
8
Ablation
8
Precautions
9
General Precautions
9
Environmental and EMI Precautions
9
Precautions During Electrosurgical Device
9
Use
9
Precautions Specific to the Acessa Provu System
9
Precautions Concerning Acessa Provu
9
System Guidance Accuracy
9
Precautions Specific to Uterine Fibroid Ablation
9
Sterilization and Safety Checks
10
Switches, Buttons, Connections, and 13.7. Display
10
Front Panel
10
Buttons, Connections and Display
10
Rear Panel
11
Switches and Connections
11
Setting up the Acessa Provu System
12
Connecting System Components
12
Before Patient Arrives
12
Patient Preparation
12
Energizing the System
13
Use of the Acessa System
13
Getting Ready
13
Accessory Connections
14
User Interface
15
Menu Setttings
16
Ultrasound Settings
16
Expected Ablation Size
16
Deployment, Ablation and Coag
16
Pad Temperatures
17
The Acessa Provu Guidance System Feature
17
Procedure Planning
19
Performing an Ablation
19
Operation of System During Coag
20
After the Procedure
20
Shutting down the System
20
Special Considerations: General Ablation Procedures
21
Highly Vascularized Tissue
21
One or more Electrode Arrays in a Duct or Vessel
21
Ablation of Dense or Calcified Fibroid Tissue
21
Ex-Vivo Studies
21
Representative Ablation Shape Per Deployment
21
Results from Ex-Vivo Bovine Liver Studies
22
Representative Ablation Sizes in Ex-Vivo Bovine Liver with Settings in Temperature Control
22
Clinical Studies - Fibroids
22
Study Design
23
Study Objectives
23
Primary Objectives
23
Secondary Objectives
23
Inclusion and Exclusion Criteria
23
Study Demographics
23
Fibroid Symptoms and Characteristics Reported at Baseline - All Subjects
24
Treatment
24
Results of the Pivotal Study
25
Safety
25
Efficacy
26
Surgical Reintervention Rate
26
Uterine and Fibroid Volume
26
UFS-QOL Scores
27
EQ-5D Health State Score
28
Overall Treatment Effect (OTE) Survey
28
Data Regarding Return to Work and Return to Normal Activities
28
Data Regarding Pregnancy
28
Data Regarding Calcified Fibroids
28
Therapeutic Medications at 24 and
28
Months Post-Treatment
28
Postmarket Surveillance Study - TRUST (Treatment Results of Uterine Sparing Technologies)
29
Summary of the Post-Approval Study Methods
29
Study Objective
29
Study Design
29
Study Population
29
Data Source
29
Key Study Endpoints
29
Primary Endpoint
29
Secondary Endpoint
29
Total Number of Enrolled Study Sites
29
Results
30
Final Safety Findings (Key Endpoints)
30
Study Strengths and Weaknesses
31
Potential Risks of Acessa Provu System
31
Patient Counseling
32
Care and Maintenance
32
Software Upgrades and Installation
32
Maintenance
32
Cleaning and Disinfecting the Console
32
Calibration Verification
32
Specifications
32
System Specifications
32
Guidance and Manufacturer's Declaration
33
Technical Characteristics
36
Compliance to Safety and Performance Standards
37
Trouble Shooting
37
Faults, Alerts, and Errors
37
Fault/Alert Code Table
37
Glossary of Symbols and Product Graphics
40
Symbols
40
Product Graphics Glossary
41
Warranty Statement
42

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Hologic Acessa ProVu User Manual (42 pages)

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