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Atos Medical Provox Vega XtraSeal User Manual

Atos Medical Provox Vega XtraSeal
92 pages
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Vega
XtraSeal
IFU
MD
RT

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Atos Medical Provox Vega XtraSeal Specifications

General IconGeneral
TypeVoice prosthesis
ModelProvox Vega XtraSeal
MaterialSilicone
XtraSeal FlangeYes
SterilitySterile
Single UseYes
IndicationVoice rehabilitation after total laryngectomy
Featuresenhanced sealing

Summary

Descriptive Information

Intended Use

Defines the product's purpose and application in voice rehabilitation.

Description of the Device

Details the physical characteristics and components of the Provox Vega XtraSeal.

Contraindications

Lists situations where the device should not be used for patient safety.

Warnings

Highlights potential risks, severe adverse events, and crucial safety information.

Precautions

Outlines necessary steps to minimize risks during device handling and use.

Instructions for Use

Choose Size of the Voice Prosthesis

Guides on selecting the appropriate prosthesis shaft diameter and length.

Preparation

Details the steps to prepare the voice prosthesis and insertion system.

Insertion, Anterograde Replacement Procedure

Provides a step-by-step guide for inserting the voice prosthesis.

Assembly and Reloading Provox Insertion System

Instructions for assembling or reloading the insertion system for use.

Finalize the Procedure

Steps to complete the insertion, check fit, test function, and cut strap.

Disposal

Guidelines for the safe disposal of used medical devices.

Important Patient Information

General Information

Key information for patients on when to contact their clinician.

Prosthesis Maintenance

Instructions for cleaning and maintaining the voice prosthesis for longevity.

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