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Atos PROVOX VEGA User Manual

Atos PROVOX VEGA
140 pages
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Vega
Puncture Set
Vega
Puncture Set
Instructions for Use
Unregistered copy

Table of Contents

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Atos PROVOX VEGA Specifications

General IconGeneral
BrandAtos
ModelPROVOX VEGA
CategoryMedical Equipment
LanguageEnglish

Summary

Descriptive Information

Indications for Use

Details the intended use of the Provox Vega Puncture Set for TE puncture.

Contraindications

Lists conditions where the Puncture Set should not be used to avoid harm.

Description of the Device

Outlines the components of the Provox Vega Puncture Set, including the dilator.

Warnings

Pre-Surgery Warnings

Advises against using damaged packaging and re-sterilization of the device.

During Surgery Warnings

Details warnings related to pharynx protector, guidewire, and needle during surgery.

Secondary Puncture Warnings

Warns against using the Pharynx Protector during secondary punctures.

Post Surgery Warnings

Warns about dislodgement/extrusion of the voice prosthesis and related risks.

Precautions

Tissue Suitability Assessment

Emphasizes assessing tissue suitability and proceeding with care due to fibrosis.

Bleeding Risk Assessment

Advises assessing bleeding risk in patients with bleeding disorders or on anticoagulants.

Aseptic Technique

Stresses the importance of using aseptic technique to prevent infection.

Adverse Events and Troubleshooting

During Use of the Puncture Set

Addresses issues like (sub)mucosal injury, re-puncture, and forgotten Pharynx Protector.

During Use of the Voice Prosthesis

Covers dislodgement, aspiration, ingestion, infection, and granulation issues.

Instructions for Use

Preparation

Guides on determining the correct prosthesis size and diameter before use.

Operating Instruction

Details on checking sterile packaging and general operating procedures.

Primary Puncture and Prosthesis Placement

Step-by-step guide for performing a primary TE puncture and placing the prosthesis.

Secondary Puncture and Prosthesis Placement

Procedure for performing a secondary TE puncture and prosthesis placement.

Reload of the Puncture Set

Cleaning and Sterilization

Important Patient Information

Post-Placement Observations

Informs patients about potential blood in sputum and mild leakage.

When to Contact Clinician

Lists critical signs requiring immediate medical consultation.

Prosthesis Maintenance

Cleaning Procedure

Instructions for daily cleaning of the prosthesis using Provox Brush and Flush.

Compatibility with Antifungal Substances

Assesses the influence of antifungal medications on the device's material properties.

Device Lifetime

Prosthesis Lifetime Factors

Explains device deterioration due to bacteria, Candida, and other factors.

Indications for Replacement

Lists signs like leakage, blockage, or overgrowth that necessitate prosthesis replacement.

Disposal

Accessories

Device Maintenance Accessories

Lists accessories like Brush, Flush, and Plug for prosthesis maintenance.

Ordering Information

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