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Technical Datasheet BRONCOFLEX™

Technical Datasheet BRONCOFLEX™

Technical Datasheet BRONCOFLEX™

Product catalog summary
Overview: The document is a technical datasheet for TSC Life's Broncoflex devices, intended for healthcare professionals. It emphasizes the importance of consulting the latest user manuals and highlights that the equipment is for professional use only, requiring training and adherence to guidelines.
Product Specifications:
  • Broncoflex 5.6/2.8 (Vortex): A single-use video-bronchoscope with a 5.6mm maximum outer diameter and a 2.8mm working channel. It features a 0° field of vision direction, 87.5° field of vision, and a 400x400 pixel resolution. It is compatible with endotracheal tubes of at least 6mm and double-lumen tubes of 41Fr.
  • Broncoflex 3.9/1.4 (Agile): Similar to the Vortex but with a smaller 3.9mm maximum outer diameter and a 1.4mm working channel. Compatible with endotracheal tubes of at least 5mm and double-lumen tubes of 35Fr.
  • Screeni: A reusable high-definition display system with a 10.1-inch touch screen, 1280x800 resolution, and a lithium-ion battery with 3 hours of autonomy.
  • Easy BAL Clip: A small accessory made of ABS-PC, biocompatible, and free from DEHP and latex.
Intended Use: The Broncoflex devices are designed for optical display of the pulmonary tract in hospital environments, exclusively for adult patients. They should be used with endotherapy accessories and instruments.
Regulatory and Safety Information: The devices have FDA 510(k) clearance, CE mark, and are classified under Class IIa (MDD 93/42/EEC) for Broncoflex and Screeni, and Class I (MDR 2017/745) for Easy BAL Clip. They are sterilized using Ethylene Oxide (EO).
Packaging and Storage: Broncoflex devices are packaged in sterile Tyvek® pouches and carton boxes. Recommended storage conditions are in a clean, dry, and dark place at 20°C and 1.013 bar.
Environmental Conditions: The devices can be transported and stored between -10°C to +60°C, with relative humidity between 10% to 90%. Usage conditions range from +10°C to +40°C, with 30% to 85% relative humidity.
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Catalog excerpts

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 | [email protected] | 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 bronchial...

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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 UL....

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