25.05.2020

Genesys Hta System User's Manual

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Genesys Hta System User's Manual 4,6/5 9857 votes
  1. GeneSys determines the optimal hardware configuration (camera control, exposure time, sensitivity setting, lighting requirements, lens control and filter selection) for your system and sets the system ready for image capture. Manual capture mode provides you with the ability to take complete control of every function of the system. 1.1 Software.
  2. Genesys Performance Management AdvisorsTM Administration User Manual Release 3.3. Genesys Advisor, Contact Center Advisor, Workforce Advisor, Alert Management, Resource. This document focuses on using the features and functions of the System Administration module. In particular, it is a reference for system administrators responsible for.
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This is the procedure set for the Genesys HTA ProCerva. It includes: a Proceduere Sheath, Cassette, and a drainage bag. The Genesys ProCerva™ Procedure Sheath provides redundant protection to help gain and maintain a cervical seal, and Seal Integrity Check verifies cervical seal before procedure initiation.

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.


Genesys HTA Post Approval Registry


General
Study StatusCompleted
Application NumberP000040 S014/ PAS001
Date Current Protocol Accepted 04/23/2012
Study Name Genesys HTA Post Approval Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A Multi-center, Single-arm, Prospective Registry of the Genesys HTATM System for the Treatment of Menorrhagia will evaluate safety and technical performance of the device at time of treatment.
Study Population Description All women treated with the Genesys HTATM System under the approved indications for use who agree to participate
Sample Size 1312 subjects at a maximum of 100 clinical sites
Data Collection Rate of clinically significant burns (primary)
Rate of technical complaints with the system (secondary)
Assessment of serious adverse events (secondary)
Interim or Final Data Summary
Actual Number of Patients Enrolled 1,014
Actual Number of Sites Enrolled 18
Patient Follow-up Rate 91.8% (931/1,014)
Final Safety Findings There have been 4 burn events: 3 non-clinically significant burns and 1 clinically significant burn were reported. The rate of this clinically significant event was 0.1% (95% CI 0.0%, 0.6%). The primary hypothesis of the PAS is that the subject rate of clinically significant burns is not significantly greater than 1.0%.
For the secondary endpoint, there has been one (1) Serious Adverse Device Effect. This was a superficial 2nd degree burn for a subject for a rate of 0.1% (95% CI: 0.0% ¿ 0.6%).
Final Effect Findings There was no effectiveness endpoint per se. The secondary objective of the study was to obtain data on technical problems with the device. Fifty-three (53) technical complaints were reported for 44 subjects in the intent-to-treat population (N=992). Therefore, the rate of technical complaints per subject was 5.3% (53/992).
Study Strengths & Weaknesses This study had an adequate sample size that was large enough to study key safety issues.
Recommendations for Labeling Changes No labeling changes are recommended

Genesys hta system user

Genesys HTA Post Approval Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report10/22/201010/22/2010On Time
one year report04/23/201104/22/2011On Time
18 month report10/22/201110/24/2011Overdue/Received
two year report04/22/201204/18/2012On Time
Final PAS Report10/22/201210/19/2012On Time

Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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Genesys hta system user

Genesys Hta System User's Manual 2017

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Genesys Hta Ablation

Boston Scientific Genesys HTA Control Unit
VENDOR DESCRIPTION: The Genesys HTA System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. The recently launched Genesys HTA System is the culmination of a multi-year effort by Boston Scientific to completely redesign the HTA System hardware. The Genesys HTA System features a smaller and lighter console, simplified set-up requirements, and an enhanced graphic user interface which offers step-by-step guidance through the procedure. The System also incorporates several technology upgrades designed to improve operating performance while delivering the same proven clinical therapy of the Company's current HTA Endometrial Ablation System.
The Genesys HTA System works by circulating heated saline throughout the uterus in order to ablate the lining of the uterine walls, also known as the endometrium. The procedure can be performed at the hospital or potentially in your doctor's office.
FEATURES:
Touch Screen
Light Weight Easy to Use on Wheeled Trolley Cart with Handle
IV Pole Attached to Cart
Adjustable height for System on Cart
SPECIFICATIONS:
115VAC/60Hz
Rated Current 6 AMPS
250V, 8A, Type T
Made In USA
Manufactured: 03/2011
CONTENTS:
Qty 1 – Boston Scientific HTA Control Unit with Cart
Qty 5 – Genesys HTA ProCerva Procedures Sets REF # 58021 (NEW)
Qty 1 – Bilary Stent System REF # 4563 10 Fr x 12 cm (NEW)
Qty 1 - HTA ProCerva Procedure Set Ref 656021 (NEW)
Only items listed in contents section are available with unit.
CONDITION:
Cosmetic: Excellent
Working: Excellent
Please feel free to contact us for additional information