Attachment 3 - Vyntus_ONE_Brochure.pdf

The power of ONE – pulmonary function testing and cardiopulmonary exercise testing

VyntusTM ONE

VYNTUSTM ONE

breath away.

will take your in respiratory diagnostics Our latest advances

Nothing is more critical to human life than air. When the ability to breathe is compromised, quality of life suffers.

That‘s what pushes us to create respiratory diagnostic systems that strive for higher levels of accuracy, and are more patient and clinician friendly than ever before.

As always, we started from the perspective of the patient. Because patient comfort isn’t just a “nice-to-have.” It’s the cornerstone of our human centric design philosophy. How will patients interact with the systems? How will they feel during the tests?

We designed Vyntus™ ONE to be hassle-free for clinicians and people-friendly for patients. Vyntus™ ONE is incredibly capable with a modular design that possesses an impressive array of features.

It is designed to make your tests more accurate, less intrusive and less stressful for patients.

Powered by our trusted SentrySuite™ software platform, the Vyntus™ ONE is easy to operate, and seamlessly integrated with your clinical information systems and existing network infrastructures. We also addressed functional aspects. We labored over hygiene and maintenance so clinicians don’t have

to. The Vyntus™ ONE is easy to clean using standard hygiene practices and readily available products like disinfectant wipes. And your Vyntus™ ONE can scale as your practice grows.

In the end, all this attention to detail offers a radical leap forward in patient comfort, accessibility and outcomes.

With unmatched ease of operation for our clinician partners.

All-in-ONE

Hygienic keyboard and mouse.

Height adjustable cart.

USB ambient module.

Big or standard cinema.

Flexible arm to fit adults and the little ones.Patient friendly innovative eDemand gas supply and

Flow Path Valve with magnetic rotary shutter mechanism.

Factory Calibrated ultrasonic sensor for high accuracy and reliability.

VyntusTM ONE key features

Built-in medical isolation transformer for your security. Optional trusted

DVT sensor.

Optional integrated SpO2 sensor.

VyntusTM ONE module.

The Power of ONE

Combine your VyntusTM ONE with various bikes, treadmills and ECG to be ready for cardiopulmonary exercise tests.

• Complete Spirometry (FVC, SVC, MVV) pre/post bronchodilator

• Bronchial Challenge Testing

• Lung Volumes, FRC by N2 washout

• MBW LCI, SnIII, Scond, Sacin

• SB Diffusion Capacity

• SB Diffusion Capacity, Intrabreath

• MIP/MEP

• P0.1

• Rocc

• CPET, breath by breath

• REE, breath by breath

• ECG, rest and exercise

ONE device - Two sensors

Ultrasonic sensor - for pulmonary function testing

Digital volume transducer - for cardiopulmonary exercise testing

Benefit from the trusted sensors for pulmonary function testing and cardiopulmonary exercise testing – each the proper technology to fit your needs

• Factory Calibrated sensor requires only simple verification so that clinicians can stay focused on patients.

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

• No mesh or screens mean a low resistance and very comfortable breathing feeling for the patient.

• Expert accuracy and stability over a wide range of flow rates.

• Light weight and compact size for your patients‘ wearing comfort.

• Ideal for high ventilation.

• Highly accurate, being insensitive to water vapor and breathing gases.

• Minimal dead space ventilation due to the low mechanical dead space.

• Your flexibility: for use with mask and mouthpiece.

With the use of the MicroGard

TM

filter, hygiene routines take less time, since cleaning and disinfection is required only twice a year.1

You can clean or replace, your choice.

We re-engineered every facet of VyntusTM ONE´s

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.

With the electronic patented demand valve the patient no longer needs to maintain a significant under-pressure during gas supply to keep the valve open. This improves the patient experience during gas inhalation, making the measurement less demanding.

eDEMAND breathing circuit, achieving significant improvments in efficiency and accuracy.

Benefit from both trusted and innovative measurement methods.

Your VyntusTM ONE is able to perform Spirometry, Diffusion SB Realtime and Intrabreath as well as FRC N2 Washout measurements.

ERS/ATS 2017 requirements

Flow Sensor Accuracy (3L Syirnge Check) +/-2.5%

USS accuracy:

Exhalation +/- 1.5% or.05L/s (whichever is greater) Inhalation +/-2.0% or.05 L/s (whichever is greater)

Inspiratory flow resistance <0.9 kPa @ 6 L/s

Average inspiratory pressure @ 6 L/s below 0.5 kPa

RealTime Analyzer response time < 150 ms

Multigas response-time 130 ms

Key Success Factors for DLCO Measurement

Vyntus ONE for SB Diffusion

Pulmonary Function Testing with your VyntusTM ONE

FR

C

N 2 W a sh ou t

Easy visualization of potential abnormalities

Volume

Normal N2 Washout Pattern

N2

Volume

Restrictive N2 Washout Pattern

N2

Volume

N2

Lung Volumes by Nitrogen Washout

• Minimizes your disposables spend as no rebreathing bag, CO2 absorber or tubes are needed.

• Automatic leak detection.

• Workflow-driven: No preparation time before starting the test and switch automatically to the next sequence during the measurement.

• Differentiation of fast and slow lung compartments.

• Measurement of Lung Clearance Index (LCI) to help in the detection of small airway abnormalities.

FRC N2 Washout allows the determination of the functional residual capacity (FRC) using the N2 Washout method as well as the determination of the absolute volumes TLC and RV by combining it with slow spirometry measurements.

Don’t have the testing volume or space to justify a completely separate CPET system?

Combine PFT and CPET testing in to a single device. You’d be hard pressed to find another pulmonary testing system that delivers so much performance and utility in one single package.

• Real-time 9–Panel-Wasserman graph with dynamic predicteds and the possible limitation graph.

• Multiple threshold evaluations (VT1, VT2, VT3), six automatic slope calculations and Tau.

• Individual pre-programmed EFVL (exercise flow/volume loops) measurements.

• Online entry of RPE scale, blood gas marker,blood pressure or events.

• Offline entry of blood gases with automatic calculation of related parameters.

• Customizable evaluation workflow.

• 12-lead ECG.

• Integrated pulse oximetry with ear-clip or forehead sensors.

Cardiopulmonary Exercise Testing with your VyntusTM ONE

Connect all your measurement devices and review workplaces in one network and benefit from one central patient database and the possibility of a HIS interface.

Save time with the stationary or web-based physican’s review tool.

• Coaching for operator and patient

• Acceptability and repeatability check against ATS/ERS

• Biological and mechanical quality control

• Authentication

• Authorization

• Audit

Guidance and quality

SecurityWorkflow driven review

SentrySuiteTM networking

Keep the overview without any program switches. All important steps; calibration, patient data entry, measurements, interpre-tation and reporting can be navigated within ONE screen.

Ease-of-use measurement concept

Your VyntusTM ONE is equipped with our trusted SentrySuiteTM software platform

We offer the highest flexibility to match your individual needs.

Your VyntusTM ONE can expand as your needs change, delivering high performance and utility in a single package.

ONE device, your flexibility – now it is your choice!

VyntusTM ONE DL VyntusTM ONE PFT VyntusTM ONE

Standard testing capabilities

Spirometry, Diffusion, SB Realtime and Intrabreath

Lungvolumes with N2 Washout method and LCI

CPET Breath-by-Breath

VyntusTM Mobile Cart

Enables you to take PFT testing on the go, including room for all the things you need to have with you.

The mobile cart is an option for the VyntusTM ONE DL and VyntusTM ONE PFT models.

The power of

ONE

Patient centricity

The VyntusTM ONE helps all patients to easily perform the maneuver.

Innovation

The VyntusTM ONE technology drives high quality results, accuracy and repeatability.

Hygiene

The VyntusTM ONE combined with

MicroGardTM filters makes hygiene routines fast and easy.

VyntusTM WALK a complete mobile solution for the 6-minute walk test.

VyntusTM CPX the specialist for cardiopulmonary exercise testing, high/low FIO2 REE measurement.

The right diagnostics for each individual patient.

The Vyaire VyntusTM systems deliver everything for your pulmonary function testing needs. And since SentrySuiteTM software powers all of them, it’s easy to navigate through all systems and tests with a consistent and intuitive user interface.

What’s more, future VyntusTM innovations to come will follow this same approach.

Keep up with every VyntusTM innovation

We help people catch their breath, but we´re not stopping to catch ours.

Vyaire represents a powerful force dedicated to the simple act of breathing. Today, you’ll find our unique products are giving clinicians all across the world the power to diagnose, treat and monitor respiratory conditions like never before.

And we’re not about to slow down now. We will continue to evolve and expand the complete VyntusTM line of testing devices.

Tomorrow and all the days after.

VyntusTM BODY for body plethysmography as stand alone device or in combination with the VyntusTM

ONE.

VyntusTM SPIRO for all essential spirometry tests including, medication testing and animation incentives.

GLOBAL HEADQUARTERS

Vyaire Medical, Inc.

26125 N. Riverwoods Blvd.

Mettawa, IL 60045

USA

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-2300074 | 1.0

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: Repor t 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