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Atos Medical PROVOX Vega User Manual

Atos Medical PROVOX Vega
124 pages
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Voice Prosthesis with SmartInserter
Vega
Instructions for Use
Clinician’s
Unregistered copy

Table of Contents

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Atos Medical PROVOX Vega Specifications

General IconGeneral
Device TypeVoice prosthesis
MaterialSilicone
Material GradeMedical grade
IndicationsVocal rehabilitation after laryngectomy
Valve TypeLow resistance valve
X-ray visibilityRadiopaque
FeaturesLow resistance
Product TypeVoice prosthesis

Summary

Prescription Information

US Federal Law Restriction

US federal law restricts sale and use to licensed practitioners. Availability varies globally.

Disclaimer

Atos Medical disclaims warranties regarding product lifetime and fitness for purpose.

Patents and Trademarks

Provox is a registered trademark of Atos Medical AB. Patent info is on their website.

Descriptive Information

Indications for Use

Intended for voice rehabilitation after laryngectomy; cleaned in situ by the patient.

Device Description

One-way valve for speech, reducing fluid/food risk. Made of silicone and fluoroplastic.

Contraindications

No known contraindications for patients already using prosthetic voice rehabilitation.

Instructions for Use

Preparation

Choosing proper shaft diameter and length for the prosthesis.

Anterograde Replacement Procedure

Step-by-step guide for replacing the prosthesis using the SmartInserter.

Voluntary Overshooting Procedure

Procedure for inserting prosthesis when the tract is short or mucosa folds over.

SmartInserter Reloading

Instructions on how to reload the SmartInserter if the initial insertion fails.

Important Patient Information

Patient Guidance

Patient should contact clinician for specific issues; may see blood or mild leakage initially.

Prosthesis Maintenance

Patient instructions for cleaning the prosthesis using genuine Provox accessories.

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