Technical Datasheet BRONCOFLEX™
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Technical Datasheet BRONCOFLEX™ - 1

Technical Datasheet Innovation with purpose Note: Always consult the latest User Manual of Broncoflex devices. 1. Broncoflex User Manual ref. 1003012 2. Screeni User Manual ref. 30030511 3. Easy BAL Clip User Manual ref. 41040406 The use of our medical equipment is solely intended for the use of healthcare professionals. Healthcare professionals have the obligation to exercise their own professional clinical judgment when determining the suitability of a specific product for treating an individual patient. TSC Life does not provide medical advice and strongly advises healthcare professionals to undergo training on the usage of any specific product before using it. Healthcare professionals should consistently refer to the package insert, product label, and/or instructions for use, including guidelines for cleaning and sterilization (if applicable), before utilizing any product supplied by TSC Life. The information presented aims to display specific products and the extensive range of offerings from TSC Life. Availability of products may vary across markets due to regulatory and/or medical practices specific to each region. For inquiries regarding the availability of specific TSC Life products in your area, please reach out to your TSC Life representative. Single-use Bronchoscopy. Everything you need. Nothing you don’t. TSC Life Zone de La Liodière | 6 rue de la Flottière | 37300 Joué-lès-Tours | France T +33 2 47343290 | letsconnect@tsc-life.com | www.tsc-life.com Manufactured by : Axess Vision Technology, S.A.S.

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Technical Datasheet BRONCOFLEX™ - 2

Single-Use Broncoflex Sizes Description Broncoflex™ is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable high-definition display system (Screeni™). Two different bronchoscopes are available: Combined with: Broncoflex 5.6/2.8 (Vortex) Intended Use This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a moni tor (Screeni) and to be used with endotherapy accessories and instruments. The pulmonary tract includes the organs, tissues and subsystems represented by the nasal passages, trachea and...

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Technical Datasheet BRONCOFLEX™ - 3

Screeni Description Innovation with purpose

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Technical Datasheet BRONCOFLEX™ - 4

Safety Properties • DEHP free. • Does not contain latex or latex components. • Biocompatible according to ISO 10993-1 for the intended use. Each single-use device has a sterile barrier made of a Tyvek® pouch with a protective blister inside. Broncoflex devices are packaged in carton boxes of 5 products. Each Broncoflex carton includes a label indicating sterilization by EO. Carton packaging box, dimensions 980 x 110 x 130mm. User Manual, carton box and unit labelling/carton box labelling are included. FDA 510(k) clearance, Regulatory Class II. Electrical Safety Certified Body Certificate by...

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