Attachment 4 - Vyntus_BODY_Brochure.pdf

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Vyntus One PFT System with Bicycle Ergometer (Brand Name or Equal) - Travis AFB, CA
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FA442725Q1034
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About this file

This document is a product brochure for the Vyntus BODY body plethysmography medical device manufactured by Vyaire Medical. The brochure highlights key features of the device, including a flexible telescoping arm that can extend up to 25 inches, allowing measurements for patients in wheelchairs, and a spacious cabin with a low entry step. The device includes advanced technological innovations such as an ultrasonic sensor with Double Shot Technology for enhanced data resolution, a MicroGard II filter to prevent cross-contamination, and is controlled by the SentrySuite software package that enables comprehensive pulmonary function testing.

The device offers extensive measurement testing capabilities, including complete spirometry, lung volumes, airway resistance, diffusion capacity, and multiple other respiratory function assessments. It follows ATS/ERS (American Thoracic Society/European Respiratory Society) guidelines and supports a range of diagnostic tools, such as the Resistance Volume Chart, which combines airway resistance and lung volume results. The brochure emphasizes the system's ease of use, with the software allowing operators to perform a full workflow in less than two minutes, and includes features like graphical patient guidance, quality control, and versatile reporting options.

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Text version

Body Plethysmography - Designed to be different

VyntusTM BODY

VYNTUSTM BODY

Stable hand grip.

Low entry step less than 3“.

VyntusTM BODY key features

Ultrasonic sensor for high accuracy.

Equally spread magnets for a tight closure of the door.

Spacious cabin with 1110 L.

Height adjustable cart.

Digital Pressure Compensation.

Bench - for up to 551lbs.

Flexible arm.

Flexibility that makes VyntusTM BODY different

The flexible telescoping arm of the

VyntusTM BODY:

• Can be extended outside of the cabin up to an impressive reach of 25 inches.

• Patients in a wheelchair can be measured easily and comfortably outside the cabin.

• Is adjustable in height and position and perfectly adapts to your patients‘ needs.

Open phone camera and hold over QR code

Scan the QR code below to visit the US BODY showcase app

VyntusTM ONE

• Complete Spirometry (FVC, SVC, MVV) Pre/Post Bronchodilator

• Bronchial Challenge Testing

• Lung Volumes, FRC by Body Plethysmography

• Airway Resistance, Resistance Volume Loops

• SB Diffusion Capacity

• Diffusion Capacity, Intrabreath

• MIP/MEP

• P0.1

• Rocc

• Lung Volumes by N2 Washout*

• MBW LCI, SnIII, Scond, Sacin.*

• CPET, Breath by Breath*

• REE, Breath by Breath*

• ECG, Rest and Exercise*

*requires addition of VyntusTM ONE.

Measurement testing capabilities

We re-engineered every facet of VyntusTM BODY´s breathing circuit, achieving significant improvements in efficiency and accuracy.

Ultrasonic sensor

Simple, maintenance free, magnetically-controlled rotary shutter is highly responsive to patient effort.

This means an easier and noise reduced testing experience.

Flowpath valve

Time

Double shot technology:

Time of flight measurement

Double shot

Single shotwith airflow against airflow

Polytubes

Turbulent Laminar

Double Shot Technology measures twice the number of signals across the flow path providing enhanced data resolution and precision.

Dynamic Flow Correction: gas temperature is measured with each breath. With this information an on-line BTPS correction is carried out minimizing drift and providing higher accuracy.

Polytubes on both sides of the ultrasonic sensor for flow conditioning.

Factory calibrated: stay focused on your patients.

Waterproof: makes hygiene routines fast and easy. There is no need to disassemble and reassemble the sensor for the cleaning process.

Stop cross-contamination!

The MicroGardTM II filter:

• Reprocessing cycle for parts behind the filter can be reduced to twice a year using the MicroGardTM filter1 .

• Protects your patients, staff, environment and instruments from viral and bacterial contamination.

• Follows the highest safety standards.

• Has an exceptionally low resistance to air flow.

• The impact on measurement results is completely removed.

• Is the only validated filter for the

VyntusTM BODY.

Easy and optimized post-test decision making -visual diagnostic using the Resistance Volume Chart

Guidance and coaching Quality control Results review

The Resistance Volume Chart combines airway resistance and lung volume results in a single breath with no changes in the testing procedure:

Smart diagnostics – Improve clinical outcome while saving valuable time

The VyntusTM BODY is controlled by the powerful and easy to use SentrySuiteTM software package. In less than two minutes any operator can smoothly perform a workflow including airways resistance, lung volumes, subdivisions and forced spirometry.

Quick recognition of pre-post benefit of the therapy

Easily analyze the shape of the entire breathing cycle

Predicted area for quick orientation

• Graphical and textual guidance for improved patient instruction and control

• Choice of 10 incentives for children and non-cooperative patients

• Highly versatile report program for parameters, graphs and comments

• Features like Z-score calculation, classification bars and interpreta-tion schemes, based on reference values of numerous authors

• Follows ATS/ERS standards and recommendations

• Quality tab for fast and extensive error detection

For U.S. distribution only.

Trademarks are the property of their respective owners.

© 2023 Vyaire. Vyaire, the Vyaire logo and all other trademarks or registered trademarks are property of Vyaire Medical, Inc., or one of its affiliates. VYR-US-2300073 | 1.0

GLOBAL HEADQUARTERS

Vyaire Medical, Inc.

26125 N. Riverwoods Blvd.

Mettawa, IL 60045

USA

ATS/ERS guideline implementation - Your base for high quality results

ATS standardized PFT reports4

ERS/ATS 2019

spirometry guidelines2

ERS/ATS 2017

diffusion guidelines3

1. Based on the Bio Burden DIN EN ISO 11737-1: Report 18AA0193.

2. Graham B, Steenbruggen I, Miller M, et al. Standardization of spirometry 2019 update. An official american thoracic society and european respiratory society technical statement. Am J Respir Crit Care Med. 2019; 200:e70-e88.

3. Graham BL, Brusasco V, Burgos F, et al. 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung.

Eur Respir J 2017; 49: 1600016.

4. Culver BH, Graham BL, Coates AL, Wanger J, Berry CE, Clarke PK, et al.; ATS Committee on Proficiency Standards for

Pulmonary Function Laboratories. Recommendations for a standardized pulmonary function report: an Official American Thoracic Society technical statement. Am J Respir Crit Care Med 2017;196: 1463–1472.Culver et al., 2017.

SentrySuite version 3.20 or higher

REFERENCES

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