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Boston Scientific AMS 800 User Manual

Boston Scientific AMS 800
20 pages
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AMS 800™
Urinary Control System
For Male Patients
Instructions For Use
AMS 800™
Urinary Control System
For Male Patients
Instructions For Use .................................................1
English
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Boston Scientific AMS 800 Specifications

General IconGeneral
Device TypeArtificial Urinary Sphincter
ModelAMS 800
ManufacturerBoston Scientific
MaterialSilicone
SterilitySterile
Single UseYes
IndicationUrinary incontinence
ComponentsCuff, Balloon, Pump
Balloon Pressure Options61-70 cm H2O, 71-80 cm H2O

Summary

Brief Device Description

Contraindications

Warnings

Warnings - Infection and Erosion Risks

Risks of infection and device erosion due to various factors.

Warnings - Device Handling and Complications

Precautions for catheterization, revision, and mechanical issues.

Precautions

Precautions - Patient Selection and Counseling

Emphasizes pre-operative assessment and patient counseling on outcomes.

Precautions - Post-operative and Device Use Factors

Information on post-operative pain and patient attributes for device use.

Precautions (Continued)

Precautions - InhibiZone Drug Interactions and Handling

Precautions for drug interactions and solvent contact with InhibiZone.

Precautions - Surgical Procedure Considerations

Factors related to surgical sizing, migration, and technique.

Precautions - Device Related Issues

Issues related to the deactivation valve and system pressure.

Adverse Events

Incontinence Impact Scores

Physician and Patient Assessment of Continence

Surgical Revisions

Device Survival

Device Survival - Prospective Study

Device survival rates from the prospective clinical study.

Device Survival - Bayesian Analysis

Device survival estimation using Bayesian analysis.

Device Use

Post-market Registry Study Methods

Summary of Prospective Post-market Registry Study Results

Final Safety Findings

Safety Findings - Original Surgery Group

Safety analysis for the original surgery group.

Safety Findings - Revision Surgery Group

Safety analysis for the revision surgery group.

Original Surgery Group Analysis

Revision Surgery Group Analysis

Final Effectiveness Findings

Final Safety Findings (Key Endpoints)

Patient Counseling Information

Patient Counseling - Realistic Expectations

Counseling patients on realistic physical, psychological, and functional outcomes.

Antibiotic Information

Magnetic Resonance Imaging (MRI)

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