V-781381-320 - IFU - VyntusBody - V 01.00 EN

Instructions for Use
Vyntus BODY
Vyntus APS
V-781381-320
Version 01.00
for SentrySuite® Software ≥ 3.20
English
Instructions for Use Vyntus BODY/APS
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Contact:
Vyaire Medical GmbH
Leibnizstrasse 7
97204 Hoechberg, Germany
+49 931 4972-0 tel
+49 931 4972-423 fax
E-Mail: MarketingInfo.EU@Vyaire.com
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All rights, also those of translations, are reserved. Written permission of Vyaire
shall be obtained for the reproduction of the manual or an excerpt thereof by any
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Note
This document contains copyright information. All rights are reserved. It is not
allowed to copy, duplicate or translate this manual in any other language
without obtaining written approval from Vyaire. Vyaire reserves the right to alter
the information included in this document without notice.
Names of persons mentioned in the context of this manual are fictitious - any
resemblance to living or deceased persons is purely incidental and not intended.
Subject to technical modifications.

Copyright © 2021 by Vyaire Medical GmbH, Hoechberg
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Table of Contents
System Configuration Vyntus BODY...................................................................... 5
System Configuration Option Vyntus APS............................................................. 7
Indications for Use and Usability............................................................................ 8
Practical Hints..................................................................................................... 10
Symbols for Notes on Safety in Instruction Manuals............................................ 11
Declaration of Conformity................................................................................... 11
Switching on/off Vyntus BODY/Vyntus APS......................................................... 12
USS Module - Ultrasonic Sensor.......................................................................... 14
System Start........................................................................................................ 14
The Start Screen/ Home Page.............................................................................. 15
Measurements with the MicroGard Filter............................................................ 19
SeSQM-Quality Management.............................................................................. 19
Ambient Data..................................................................................................... 20
Calibration / Verification Frequency..................................................................... 21
Volume Calibration / Verification......................................................................... 22
Box Calibration................................................................................................... 29
Gas Analyzer Calibration for Vyntus BODY with Diffusion................................... 31
Enter Patient Data............................................................................................... 36
Load Patient Data ............................................................................................. 37
Show Patient Data.............................................................................................. 39
Measurement Programs...................................................................................... 42
Basic Conditions prior to starting a Measurement............................................... 43
Slow Spirometry.................................................................................................. 44
Forced Spirometry............................................................................................... 48
Maximum Voluntary Ventilation (MVV)............................................................... 51
Bodyplethysmography......................................................................................... 53
Diffusion SB Realtime.......................................................................................... 60
Diffusion SB Intrabreath...................................................................................... 67
R Occlusion (Option)........................................................................................... 74
Respiratory Drive P 0.1........................................................................................ 77
MIP / MEP........................................................................................................... 80
SNIP (Option)...................................................................................................... 86
Perform a SNIP Measurement.............................................................................. 86
Compliance (Option)........................................................................................... 89
Preparing for a Measurement.............................................................................. 89
Catheter Positioning........................................................................................... 93
Rhinomanometry (Option)................................................................................. 100
Preparing for the Measurement........................................................................ 100
Perform a measurement.................................................................................... 101
Set Visit Levels.................................................................................................. 106
Quality Assessment/Interpretation/Comments................................................... 107
Bronchoprovocation Test.................................................................................. 110
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Provocation protocol with more than one measurement application................. 130

Compressed Air Check...................................................................................... 131
Report.............................................................................................................. 132
Possible Sources of Error and Remedies............................................................. 133
Data Exchange with JAEGER JLAB/SensorMedics Vmax..................................... 133
Online Manual.................................................................................................. 134
Hygiene ........................................................................................................... 134
General Safety Precautions................................................................................ 135
Additional Safety Precautions for Vyntus CART 3.b........................................ 143
Additional Safety Precautions for Vyntus CART 3.0N / 3.1N............................ 145
Additional Safety Precautions for Vyntus BODY.............................................. 148
Additional Safety Precautions for Vyntus APS................................................. 152
Esophagus Catheter....................................................................................... 154
Graphical Symbols............................................................................................ 154
Safe Gas Handling............................................................................................ 156
Literature.......................................................................................................... 161
Return of Goods in Medical Institutions............................................................. 161
Technical Data.................................................................................................. 162
Item Numbers of Disposables, Spare Parts and Accessories................................ 167
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System Configuration Vyntus BODY
Vyntus CART 3.b Vyntus BODY with chair
Vyntus CART 3.1N Vyntus BODY with bench
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The Vyntus BODY is a whole-bodyplethysmograph and consists of a spacious

cabin with magnetic door closing mechanism, an ultrasound flow sensor (USS) and
a Flow Path Valve (shutter). The Vyntus BODY is available with height adjustable
chair or with a bench for patients up to a body weight of 250 kg. Furthermore the
Vyntus BODY can be used with the CART 3.b, the CART 3.0N, with the height-
adjustable CART 3.1N or without a cart. The Vyntus BODY is only intended for
stationary use.
The Vyntus BODY is connected via USB interface to a desktop PC build on a cart
and is used to measure:
• Absolute static lung volumes using the whole body-plethysmographic method
• Airway resistance
• Slow/forced spirometry and MVV
Optionally, the Vyntus BODY can be extended inside the cabin with
• Diffusion gas analyser for Single Breath Diffusion Real-Time with CO/CH4 incl.
Intrabreath Diffusion
• Vyntus APS aerosol provocation system for bronchial provocation
• ROcc, P0.1, MIP / MEP, SNIP, Rhinomanometry and Compliance measure-
ments.
The applied parts are indicated in the chapter “Disposables, spare parts and acces-
sories”.
A combination with other Vyntus devices is available. Further information regard-

ing to other Vyntus devices can be found in the corresponding user manual.
Source Of Energy
The Vyntus BODY cabin is directly connected to a separate wall socket.

The PC components (IEC 60950) are powered by means of a connector strip (lo
cated in the CART 3.b, 3.0N, 3.1N) which is connected to a separate wall socket.
Without a CART the PC components (IEC 60950) are connected to a separate wall
socket.
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System Configuration Option Vyntus APS
Extended Basic Module

for Vyntus APS
Vyntus APS inside the cabin
The Vyntus APS consists of the extended basic module with an integrated com-
pressor placed on the CART of the Vyntus BODY and a nebulizer unit mounted
inside the cabin. The Vyntus APS is connected to the same PC like the Vyntus
BODY via USB interface.
The software-controlled Vyntus APS (Aerosol Provocation System) allows easy

and reproducible administration of different aerosols for specific and non-specific
provocation tests in order to examine the reaction of a patient‘s respiratory system
to the administered aerosols.
Specific measurement applications of the Vyntus BODY are used to observe the
provocation test.
The applied parts are indicated in the chapter “Disposables, spare parts and
accessories”.
Source Of Energy
Vyntus APS is connected to a medical power supply (Magic Power MPM-X125)

according to IEC 60601-1 3rd Edition. This specific Powersupply is powered by
means of a connector strip (located in the CART 3.b, 3.0N, 3.1N)
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Indications for Use and Usability
Indications for Use:

The Vyntus/SentrySuite product line is intended to be used for measurements,
data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET)
parameters, aiding in the diagnosis of related conditions. The results of the test
can be viewed online with the help of a computer screen and can be printed
after the test. The test results can be saved for future reference or report
generation purposes.
The products can be utilized with patients age 4 years and older as long as
they can cooperate in the performance - no special limit to patient’s sex or
height exists.
Measurements will be performed under the direction of a physician in
a hospital environment, physician’s office or similar setting (professional
healthcare facilities).
A qualified physician has to reassess all Vyntus/SentrySuite measurements. An
interpretation by Vyntus / SentrySuite is only significant by confirmation of
other clinical findings.
Additional for Vyntus APS:
Use of the option Bronchial Challenge requires the supervision of a physician
familiar with emergency medicine.
The patient’s case history has to be matched with the contraindications

possibly existing for the individual measurement methods in order to minimize
the risk to the patient.
For references see the recommendations of ATS and ERS:
Considerations for Lung Function Testing:
http://www.thoracic.org/statements/resources/pft/PFT1.pdf
Guidelines for Methacholine and Exercise Challenge:
https://www.thoracic.org/statements/resources/pfet/methacholine1-21.pdf
Additional reference is the “Pulmonary Manual”:
http://www.thoracic.org/professionals/pulmonary-function-testing/
The application of this system is restricted to authorized and trained personnel

only who can guarantee for the correct usage of the device.
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Information on Usability:
Ambient requirements:
- Use of the medical product in a medical environment (e.g. doctor‘s office,
clinic, hospital)
- For diffusion single breath (Realtime and Intrabreath) measurements a good
ventilation of the room with fresh air must be ensured.
- Communication with the patient must be ensured (e.g. eye contact, duty of
care)
- Ambient conditions see section “Technical Data“
User requirements:
- Operation only by specially trained physicians or medical technicians
- Reading and comprehension of accompanying documents
- Adequate computer skills incl. operating elements
- Communication with the patient and the medical product must be ensured
(use of e.g. visual and acoustic aids)
Patient requirements:
- Adequate patient cooperation is ensured
- Use with patients who are at least 4 years of age is possible
- No restrictions with regard to height, weight and gender
General requirements:
- The patient must not be left unattended during the measurement.
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Practical Hints
Instructing the patient:
Many of the patients will not have performed a pulmonary function test before.
These patients (but also experienced ones) may be agitated and nervous. It will be
in the interest of the operator and patient if the procedure is thoroughly explained
with regard to the time taken and purpose of the test.
Prior to a patient‘s first examination of the day, it is important to give the patient
a waiting period of 10 to 15 minutes to relax and to normalize his/her ventilation
which might be increased due to walking etc.
A qualified physician has to reassess all Vyntus/SentrySuite measurements. An

interpretation by Vyntus/SentrySuite is only significant by confirmation of other
clinical findings.
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A

PHYSICIAN.
For more detailed information on the programs refer to the Online Manual
which can be called up from every application program.
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Symbols for Notes on Safety in Instruction Manuals

Following the ANSI recommendations (American National Standards Institute)
for safety notes, specific passages of the instruction manual are clearly marked as
safety notes.
Injury to Damage
Degree of Danger Use in case of:
Persons to Property
DANGER indicates an imminently hazardous situation which,

if not avoided, will result in death or serious injury.
X
This signal word is to be limited to the most extreme
situations.
WARNING indicates a potentially hazardous situation which,

X
if not avoided, could result in death or serious injury.
CAUTION indicates a potentially hazardous situation which,

X (X) if not avoided, may result in minor or moderate injury. It may
also be used to alert against unsafe practices.
Additional icons shown in the instruction manual:
See instruction manual and documents delivered with the

X X
equipment.
Important and useful information. Information does not warn

of dangerous or harmful situations.
Hints for use.
Declaration of Conformity
The original document of the Declaration of Conformity can be found in the

Accompanying Documents. Alternatively, the Declaration of Conformity can be
requested from the manufacturer.
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Switching on/off Vyntus BODY/Vyntus APS

Power status
“I/O“ switch
Switching on:
Use the “I/O“ switch on the backside of the cabin for switching on.
The Power status is shown at ceiling cover inside the cabin.
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I/O Switch
CART 3b:
Switch on the PC, monitor and printer. It is not necessary to switch on the
Vyntus APS or its respective power supply unit separately. As soon as the PC is
turned on, the Vyntus APS device will automatically exit standby mode.
CART 3.0N / 3.1N

On/off switch CART 3.0N / 3.1N Use the “I/O“ switch for switching on the Vyntus CART. Subsequently it will be
lit green. Switch on the PC.
All
All system
system components,
components, which
which connected
connected toto wall
wall sockets
sockets must
must be
be easily
easily
accessible, allows to disconnect easily the system during an incident.
accessible, allows to disconnect easily the system during an incident.
Isolating
Isolating from
from supply
supply mains:
mains: For
For safe
safe disconnection
disconnection from
from the
the mains,
mains, the
the
power supply cord must be pulled.
Switching off:
Use the “I/O“ switch again for switching off the cabin.
CART 3b:
Shut down the PC. Switch off the monitor and the printer. It is not necessary/
possible to switch off the Vyntus APS device or its respective power supply unit
separately. As soon as the PC is switched off, the Vyntus APS device automati-
cally enters standby mode.
CART 3.0N / 3.1N

To avoid data loss, shut down the PC before switching off the system. As soon
as the PC is switched off, the Vyntus APS device automatically enters standby
mode. Use the “I/O“ switch again for switching off the Vyntus CART.
Switching on / off the CART has no influence on the Vyntus BODY as it is

powered by a separate wall connection. But as soon as the CART (PC) is
switched off, the Vyntus BODY device automatically enters standby mode.
If the system is not used for a longer period of time, disconnect the power
supply of the Vyntus BODY device from the mains.
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USS Module - Ultrasonic Sensor
Connect the USS MicroGard adapter to the USS Module, then connect the
MicroGard filter to the USS MicroGard adapter (see picture).
Please use a new MicroGard filter and a clean mouthpiece for every patient.
In order to ensure firm hold USS module and the demand valve, press both
components together and slightly turn them while attaching them to the FPV
block.
USS MicroGard Adapter

USS Module
MicroGard filter
Connection cable
Please make sure that the two

marks are aligned.
Prior to connecting the MicroGard filter, hygienic hand disinfection must be

performed (the general hygiene regulations of the doctor‘s office or the clinic
are applicable).
System Start
To start the SentrySuite Software just double-click the <Launch SentrySuite>
symbol on the Windows® desktop.
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The Start Screen/ Home Page

The Home Page is an important part of your daily work with the system. After
starting the system, the Home Page is displayed automatically and runs as long as
you are working with the system.
It is possible to access all applications from the Home Page.
The programs are arranged in graphical items.
Short explanation of the major functions of the start screen:
In the top left-hand corner of the screen you will find the icons for entering and
searching patient data.
Main items containing calibration tools, patient data, measurements, report and
review.
For further information please see Online Manual “Home and Help”
This row shows the device warm up time. For the Vyntus BODY and the Vyntus
APS the warmup takes 5 minutes. For the Vyntus BODY with Diffusion the
warmup takes 45 minutes.
After switching on the unit, a self-test is automatically performed verifying

that all hardware modules connected to the system are functioning correctly.
Skipping the device warm up can cause imprecise measurement results.
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Measurements:
Click the icon to open a menu containing all available measurement programs.
The menu includes depending on the configuration:
- Spirometry
- Bodyplethysmography
- Diffusion SB Realtime
- Diffusion SB Intrabreath
- R Occlusion (optional)
- P 0.1 (optional)
- MIP / MEP (optional)
- SNIP (optional
- Rhinomanometry (optional)
- Compliance (optional)
- Bloodgas Data Transfer (optional)
- Offline data input
- Spirometer Data Transfer
- Bronchial Challenge (optional)
Calibration Tools:
- Volume Calibration
- Gas analyzer Calibration
- Box Calibration
The calibration check required for the measurement to be performed at regular

intervals is started from the Home Page or directly from the measurement
application.
A description of the calibration and of all measurement programs is part of this

Instructions for Use.
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The other groups contain programs that are not routinely used. Clicking the
Button „Configuration and Tools“ delivers following items:
Short description of the icons:

For more detailed information please see Online Manual „Home and Help“ and for
the programs the corresponding manuals.
Utilities: What is it used for?

Opens the generation programs:
- Questionnaire Designer Program for generating your own
questionnaires (optional)
- Bronchial Challenge generation Program for generating your own test
sequence for the provocation (optional)
- Report Designer Program for generating your own reports
- Predicted Values Program for generating your own
predicted values
- User Parameter Program for generating your own user
parameters (optional)
- Interconnectivity Manager Program to import JLAB/Vmax/SPCS data
into the SentrySuite database
The operator is responsible for the change of predicted modules, authors or

the entry of new predicted value formulas.
Configuration:
Connectivity... Program for configuring GDT/HIS settings
and for checking the connectivity to other
databases (such as JLAB, Vmax etc.).
Please contact Vyaire tech support for
further advice.
System Configuration Program for hardware/software
configuration
Global Settings... Program for performing settings which
usually are only performed once
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Database Handling:
Opens the programs:
- Backup/Restore Program for performing a backup and
restore of the complete SQL database
including the stored patient and
measurement data
- Data Export/Import... Program for exporting or importing data
which has been created in SentrySuite
(see Online Manual “Home and Help”)
- Patient Data Management Program for changing the patient
ID, deleting selected patient and
measurement data, and moving
measurement data (visits, levels,
measurements) (optional)
Caution:
Program only for experienced operators.
User Administration:
Opens the programs:
- User Administration Program for the administration of users
and groups including distribution of
rights (optional)
The programs listed above are not described in this Instructions for Use. For a
detailed description refer to the Online Manual which can be started directly
from the individual programs.
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Measurements with the MicroGard Filter
To ensure optimal patient safety, use the MicroGard filter. Before

measurements are performed with the MicroGard filter, the bacterial filter has
to be activated in SentrySuite.
For Vyntus BODY with USS module, the use of the MicroGard filter is
mandatory.
Procedure:
1. On the Home Page click “Configuration and Tools”, select “Configuration”

and click on <Global Settings>.
2. Change to the “General Measurement” tab
3. Tick “Bacterial filter in use“.
Ticked means: The software corrects the influence of the bacterial filter for the
determination of the volume (BTPS correction).
Additional filter settings can be found in the settings of the

measurement programs. Refer to the Online Manual of the respective
measurement program.
SeSQM-Quality Management
It is possible to check the measurement accuracy of the measurement system

in the following ways:
1. Biological quality control measurements
2. Mechanical quality control measurements under real conditions for the
measurements:
- Diffusion: check volume VCIN, VA
- Bodyplethysmography: check volume FRCpleth
- Spirometry: check volume VCIN, FVC
For detailed information on how to perform such SeSQM measurements,

please refer to the Online Manual.
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Ambient Data
The ATP-BTPS correction factor for inspiratory flows and volumes will be
determined from the ambient data. Therefore, ambient data have to be
updated at regular intervals. Incorrect or unprecise ambient data will result in
incorrect measuring results.
If an Ambient Unit is included in the delivery package, the current values for room
temperature, relative humidity and barometric pressure are recorded with the help
USB-Ambient Unit of this module and automatically saved in the system.
In order to assure correct data, the Ambient Unit must neither be exposed to
direct sunlight nor positioned near heating elements.
If the lung function measuring station is not equipped with an Ambient Unit, the
current ambient data are to be entered manually. In this case, room temperature,
relative humidity and absolute barometric pressure need to be determined by
a small home weather station and entered manually in the entry mask of the
Ambient Data screen menu.
If the ambient data change by more than 2 °C / 2 °F for temperature and 10 %
for relative humidity, the current ambient conditions should be entered again in
order to ensure that the parameters, especially inspiratory values, are determined
correctly. The calibration procedure does not need to be repeated.
To enter the current ambient data manually or to check the data transferred into
the system via the Ambient Unit, click on the “Ambient Data“ symbol.
The ambient data program can be selected from each application (e.g.
spirometry, Body...) and each calibration program.
Following window appears:
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If no ambient unit is available, the ambient data is to be entered manually by

clicking <Manual entry>.
Click on the corresponding blue field of the respective ambient unit and
enter the current ambient data.
Enter ambient pressure always as absolute pressure (not compensated)!
Click <Save> to save the ambient data just entered.
Calibration / Verification Frequency
A calibration of the sensor system has to be performed as follows:

Volume verification - daily
(USS module) - after the exchange of the USS module
Volume calibration - monthly for system check

(Vyntus APS) - after changing the type of filter

Gas analyzer calibration - daily (Vyntus BODY with Diffusion)

- after the exchange of the gas cylinder
- after the exchange of the gas sample tube
Box calibration - daily
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Volume Calibration
The measurement recording systems Vyntus APS must be calibrated in order to
determine flow and volume.
As a result of the calibration, the computer will calculate gain factors, which will
be considered in the later measurements in order to assure that the values achieve
the maximum accuracy.
Volume Verification
Verification only serves to check an existing calibration. Calibration data will not
be overwritten and will be preserved.
Only the deviation from the predicted value, i.e. the pump volume of 3 liters, will
be checked, i.e. volume accuracy should be within a range of ± 3.5 %.
The USS module is calibrated ex works. Therefore, further calibration is not

necessary with the use of the USS module.
To ensure correct measurement data, however, a verification needs to be
performed daily for the USS module together with the MicroGard filter.
Volume Calibration / Verification

The volume calibration/verification can either be started by calling up the
“Calibration Icon” on the Home Page and selecting <Volume Calibration> or
from any measurement program.
Start of the program from one of the measurement programs:
Call up “Calibration“ and select <Volume calibration> or, respectively,
<Volume verification>.
Please note:
If the volume calibration is started from the Home Page via “Calibration
Icon” and <Volume Calibration> on a combined measurement system, the
type of system to be calibrated must be selected first.
Depending on the existing system select the corresponding measuring system for
performing a volume calibration/verification.
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For performing a calibration/verification all parts where patients breathe

through must be new or disinfected for preventing cross contamination with
the calibration syringe. For the Vyntus BODY with USS Module, the MicroGard
filter must be used during the verification procedure.
Volume Calibration/Verification using the Vyntus BODY and Vyntus APS
Before starting the actual calibration/verification, the USS Module including USS
MicroGard adapter and MicroGard filter must be connected to the calibration
syringe (see picture below). If the measurement is performed without using a filter,
like Vyntus APS, calibration must also be performed without a filter.
Please make sure that the two marks are aligned.
During volume verification using the Vyntus BODY with Diffusion option, the drying
tube needs to be connected to the adapter nipple.
MicroGard IIC/B filter

Vyntus BODY Syringe
USS Module
USS
MicroGard Adapter
Vyntus APS
APS unit
Make sure to pump slowly and regularly and do not exceed the pump flow of
2 L/s.
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Standard Flow-Volume Calibration and Verification
If auto start has been set, calibration/verification can be started directly. Otherwise,
start the calibration/verification with <F1> “Start”. If Vyntus BODY is selected as
measurement device, then automatically volume verification (instead of calibration)
is started.
On the screen you are asked to move the pump piston smoothly back and
forth. It is important to pump without interruption from impact to impact.
The first pump stroke is not relevant for the calibration/verification result
and will be discarded.
1 pump stroke = pump twice, i.e. from impact to impact
If a volume calibration is proceeded and

the measured volumes are within the
± 6 % limits, it can be assumed that
calibration has been successful. If the
volumes are outside the ± 6 % limits,
a verification should be performed to
check calibration.
If, however, the screen resistance of the
pneumotach is outside the tolerated
limit, a warning message will appear.
The peak flow achieved

during pumping is shown by
the bar indicator.
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After a predefined number of pump strokes the results of the calibration/verifica-

tion will be displayed.
Screen display after calibration:
The upper part of the screen shows the results of the last saved calibration “Prev“
and of the current calibration “Act“ as well as the difference “%Diff“ between
“Prev“ and “Act“. The current volume values must be within an accuracy of
±6 %.
The mean values are calculated from the individual pump strokes (column “1-4“)
and displayed in the “Act“ column.
The lines “Gain ex“ and “Gain in“ show the gain factors calculated for expiration
and inspiration.
The middle part of the screen shows the individual pump strokes as a Flow-Volume
curve on the left side and as a bar diagram in liters on the right side.
The accuracy range of ± 6 % is indicated by the vertical lines in the graph to the
left and the right.
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If all quality criteria are met, the following message will be displayed:
“Gain and quality factors within their limits“
The “Calibration result“ is “Ok“.
Calibration result:
If calibration meets all relevant criteria, this is indicated by the bar indicator in the
bottom right part of the screen: the blue rectangle is at the right end of the bar
indicator (“OK“).
If calibration has not been successful, the user is prompted to repeat the trial.
If the quality criteria are not met, a corresponding prompt will appear and the
calibration result is assessed to be “Not Ok“.
If, for example, “Quality factor out of range“ is displayed, the calibration must
be repeated with <F1> “Start”.
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Calibration means:
The existing calibration data will be completely replaced by the results of the new
calibration.
Verification means:
Verification only serves to check an existing calibration. Calibration data will not
be overwritten and will be preserved.
Only the deviation from the predicted value, i.e. the pump volume of 3 liters, will
be checked, i.e. volume accuracy should be within a range of ± 3.5 %. It is recom-
mended to use a 3-L pump.
The volume accuracy can be set within the settings of the program volume calibra-
tion. Volume accuracy can be 3.5%, 3.0% or 2.5%.
Note: During the verification process a maximum of two strokes beyond the
verification limit are ignored. The operator has two more strokes to achieve the
verification limit.
Screen display after verification:
Only the deviation from the predicted value, i.e. the set, certified pump volume,
will be checked. That means the volume accuracy should be within a range of
± 3.5 %.
The ± 3.5 % tolerance is made up of 0.5 % maximum variation of the pump
volume and 3 % acceptable spread of the flow-volume sensor.
As a rule, the pump volume used for verification corresponds to the volume used
for calibration.
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If the volume verification/calibration has failed, please check the

following:
Devices with a sample line (devices measuring Diffusion SB Real-time):
- Please check that the sample line is connected to the adapter of the
flow sensor to avoid that there is an open hole.
Devices with ultrasonic sensor (Vyntus BODY):

- Please check that all parts are correctly assembled (USS, USS adapter
and MicroGard filter).
- Please try to use another new MicroGard filter.
In general please check that your syringe is not leaking and re-calibration cycle
of the syringe is ensured.
If all above does not help please contact Global Customer Support.
You can find the contact data at the end of your Instruction for Use.
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Box Calibration
The program “Box Calibration“ allows the calibration of the sensor system (shift
volume) and the verification of the leak tightness of the box (time constant).
The Box Calibration should be done at least once a day, preferably 10 minutes
after having switched on the unit. As a result, the computer will calculate
important calibration factors.
Wrong calibration factors will produce incorrect measuring values.
The box calibration program can either be started by calling up the “Calibration
Icon“ on the Home Page and selecting <Box Calibration> or directly from the
measurement program.
Start of the program from the measurement program

Bodyplethysmography:
Call up “Calibration“ and select <Box Calibration>.
Preparing a Box Calibration
Click <F7> to activate the door magnets.

Close the door of the body box by pressing it to the door magnets.
Pressure fluctuations from outside e. g. slamming doors, vibrations etc. cause

disturbances of the calibration and of the measurement. These lead to an
increasing variability factor (CV%), i. e. the calibration becomes incorrect.
During calibration or measurement the box should not be exposed to

direct sunlight.
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The box calibration is started with <F1> “Start“.
We recommend to not skip the two minutes waiting time. This ensures that
there are stable pressure and temperature conditions in the box.
After the start, the box calibration runs fully automatically.

Three trials are carried out for each of the following calibrations:
1. Tau verification (time constant (Tau) = half-life in s; half-life = 8-12 s)

2. Shift volume calibration (gain and quality coefficient CV%)
At the end of the calibration the result is displayed.
The right part of the screen shows the quality of the single parameters by means
of two bar indicators. “Gain” and “time constant” should be in the green range.
Furthermore, the blue rectangle in the window “Calibration result” at the
bottom of the screen should be positioned on “Ok”.
It is possible to repeat the complete Box Calibration or only the Tau verification or
the shift volume calibration if required.
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Gas Analyzer Calibration for Vyntus BODY with Diffusion

The program “Gas Analyzer Calibration“ allows the calibration of the inbuilt gas
analyzers.
The gas calibration program can either be started by calling up the“Calibration
Icon“ on the Home Page and selecting <Gas Analyzer Calibration> or directly
from the measurement programs which contain a breath gas analysis.
Survey of the gas calibration programs:
Calibration program Measurement program Gas concentration

CO/CH4 Diffusion SB Intrabreath 0.3 % each
CO/CH4 Diffusion SB Realtime 0.3 % each
Approved calibration gas:

Only calibration gas cylinders approved by Vyaire must be used.
For information about the replacement of gas cylinders please refer to

the appendix of this chapter.
Start of the program from one of the above measurement programs:

Call up “Calibration“ and select <Gas calibration>.
The gas calibration should be done once a day, preferably after having switched on
the unit (note the warmup time of 45 minutes of the gas analyzers). The computer
calculates correction factors as a result of each calibration.
These correction factors will be considered in later measurements in order to
ensure that the recorded values are correct.
Incorrect correction factors will result in imprecise measuring results.
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Preparing a Gas Calibration
Prior to starting any calibration the following has to be checked:

• Has the drying tube for the gas analysis been removed from the
USS MicroGard Adapter for gas sampling and connected to the cal
gasport?
• Is the cylinder valve of the CO/CH4 gas cylinder open and is the cylinder
pressure indicated on the manometer at least 10 bars?
For the calibration, the drying tube has to be removed from the USS MicroGard
Adapter for gas sampling and connected to the cal gas port on the analyzer unit.
Important note for the Vyntus BODY with Diffusion in the corner:
Analyzer unit Analyzer unit

for gas sampling
Cal gas port
Drying tube for

gas analysis
Drying tube for
gas analysis
Important note for the Vyntus BODY with Diffusion in the ceiling:
Housing for gas ports Housing for gas ports

for gas sampling
Cal gas port
Drying tube for

gas analysis
Drying tube for
gas analysis
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Gas Calibration CO/CH4
As already mentioned above, the gas calibration can either be started from the
Home Page via “Calibration Icon“ and <Gas Analyzer Calibration> or directly
from the measurement programs
• Diffusion SB Intrabreath
• Diffusion SB Realtime
Click <F1> “Start” to start the calibration. The calibration of CO/CH4 starts
automatically. The following screen display appears:
In the different phases of the calibration appropriate messages are displayed on

the screen.
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If the gas calibration on the Vyntus BODY was more than 36 hours ago,
the gas path is automatically flushed for 3 minutes with the calibration gas
before the actual gas calibration begins. This ensures that only pure, undilut-
ed calibration gas is used for gas calibration. A time bar is displayed for this.
The flushing process can be skipped with <Cancel>.
Time bar showing the rinsing time:
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Screen display after CO/CH4 calibration:
If the calibration has been successful, a “green tick“ appears behind the
respective gas.
The bottom part shows on the left the quality check in text form.
If calibration meets all quality criteria, this is indicated by the bar in the bottom
right part of the screen: the blue frame is at the right end of the bar (“Ok“).
If criteria have not been met, the blue frame is at the left end of the bar (“Not
Ok“).
The user is requested to repeat the calibration.
By clicking <Return to ...> the calibration will be concluded and the last opened
measurement program will appear.
The “Calibration“ tab changes to “OK“ if the calibration is valid.
Note:
The C2H2 curves displayed in the screenshots are only visible with the Vyntus ONE device and are not valid for the Vyntus BODY with Diffusion
option.
Version 01.00 • 2021-02-01 Page 35/170

Enter Patient Data
Before measuring a patient for the first time, the patient‘s personal data must
be stored in the database. Predicted values are calculated from biometric data,
so please verify that the entered data is correct.
Incorrect patient data produce incorrect predicted values!
For the calculation of the predicted values, the patients biological gender is
relevant. For more detailed information regarding the gender settings, please
see the Online Manual “Patient Data“, chapter “Gender Settings“.
This information is relevant for SentrySuite® Software ≥ 3.10
For entering new patient data, click <New>.
Click <Search> to load patient data already stored

in the database. After loading the patient, it is
possible to open existing visits or to perform new
measurements.
For data privacy protection (e.g. when leaving
Click on the patient‘s name to
the room), the patient data currently displayed is
display the corresponding
deactivated by clicking <X>. Protection is removed
patient data including all visits.
by clicking <New> or <Search>.
Screen display after clicking <New>:
The Patient Chart is displayed. The cursor flashes in the first entry field
“Identification”. The program is ready for entering data.
The entry lines from “Identification“ to “Weight“ marked with an “*“ are
mandatory fields. These data are the patient’s master data including biometric
details used to calculate predicted values. All other entries are optional.
Enter data in a field and confirm each entry with the <TAB key>. The cursor will
then jump to the next box.
Click <OK> to save the patient data.
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Load Patient Data
When a patient whose data is already stored in the database comes for
another visit, you can reload his/her data from the database. You do not have
to enter the data again.
Click <Search> in the start screen.

The following screen appears:
A list of all patients whose data have been accessed recently or on the same day is
shown. The desired patient can be selected and loaded immediately.
If an existing last name and/or first name and/or ID number is entered, the
respective patient data will be displayed in the “Search result“ window as soon
as <Search> is clicked.
Another method to search for a patient is to enter the first character(s) in the
boxes Identification, Last Name, First name or Physician. Please note the following:
Enter the first character(s) in a box (for example “Sm“ for “Smith“ in the
“Last Name“ box).
Characters can be replaced by an “*“ (for example “*ith“ for Smith; “*1205*“
for JohnSmith120570).
It is also possible to search for patients who were measured within a specific
period of time, for example, all patients measured today, yesterday, within the
past 7 days, the past 30 days. A user-specific period of time (from - to) may also be
entered.
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Click <Search> without entering any search criteria to open a list of all patients.
It is advised to always use at least one alpha-numeric character to expedite your
search, especially with large databases.
Click on the desired patient. By clicking <Select> the appropriate patient data and
existing visits will be displayed.
If the desired patient cannot be found, click <New Patient> in order to enter the
patient data of the new patient.
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Show Patient Data

The Patient Chart shows all available information on a specific patient including
his/her visits.
Double-click a visit to reload it. The program automatically returns to the

last selected main screen. If “Measurements“ was the last main screen, the
corresponding measurement results will be displayed.
Add New Visit

Double-click <Add new visit> to create a new visit in the default level. The
SentrySuite default level is Pre and can be changed in Global Configuration/
Medication. The program automatically returns to the last selected main screen.
.
Click <Add new visit> and the patient data such as height and weight which
were entered prior to the last examination will be accepted.
Therefore, enter the current patient‘s height and weight in the appropriate
fields prior to selecting <Add new visit>.
Height and weight are required for the calculation of the patient‘s reference
values.
The patient details can also be edited any time. The blue fields can be modified
directly. The gray fields are write-protected. Click <Enable fields> to remove the
write protection.
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What is a Visit?
A visit is a summary of various measurements at different levels. Usually it is the

summary of a patient‘s examinations on one day.
Visit 3
Visit 2
Visit 1
A visit includes the following components:
1. General data
- Date of visit
- Time when the visit was created
- Biometric data of the patient stored to this visit
2. Levels
The type of visit is indicated by levels.
- One or several performed measurement(s) is/are assigned to each level.
- A visit can consist of several levels.
- Each level is assigned the time the level was created.
The following levels are available:
- Test = Measurements without any further definition
- Pre = Measurements before bronchodilation
- Post = Measurements after bronchodilation
- Base = Base provocation measurement (option)
- Prov = Provocation measurement (option)
- Dilat. = Bronchodilation measurement during a provocation test
(option)
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3. Measurements
The performed measurements are assigned to each level.
Spiro = Measurements in the Spirometry program
- SVC = Slow Spirometry
- FVC = Forced Spirometry or Flow-Volume curve
- MVV = Maximum Voluntary Ventilation MVV
Rocc = Measurements in the R Occlusion program
- Rocc = Airway resistance measured with the shutter pressure
method R Occ
4. Visit status
The following icons indicate the visit status:
red means: Patient data and a new visit have been created,
but no measurement has been performed so far.
yellow means: At least one measurement has been performed.
gray means: The visit is complete and at least one preliminary report
has been saved.
wine-red means: The visit is complete and at least one preliminary report
has been saved. In the measurement program in the tab
Comments/Technician “Test Review” has been activated.
blue means: The visit is complete and at least one preliminary report plus
a doctor‘s comment or interpretation has been saved.
green means: The visit is complete and at least one final report has been
saved.
green/red means: The visit is complete and at least one corrected report has
been saved. (Only final reports can be corrected).
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Measurement Programs
SentrySuite is capable of performing different types of measurements.
Depending on the system configuration, different programs are displayed on the
screen.
- Slow spirometry
- Forced spirometry (flow-volume measurement)
- MVV measurement
- R Occlusion
- Bodyplethysmography
- Bronchial Challenge
- ...
Every visit may include several levels.

Test measurement without any further definition
Pre measurement before bronchodilation
Post measurement after bronchodilation
The measurement programs allow to enter the medication

administered for every Pre and Post test. Here, the drug
required for performing the test is selected from a pre-defined list.
You may also choose the medication unit.
As soon as the examination is finished, a
pre-defined Report can either be:
- displayed on the screen
- directly printed out
- saved in the database
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Basic Conditions prior to starting a Measurement
In order to perform high-quality measurements, the following conditions

should be fulfilled:
• A waiting time of 10 to 15 minutes prior to the first examination of the
patient ensures normal ventilation as a prerequisite for a high reproducibility
of the examination results.
• To improve motivation, cooperation and coordination of the patient, the
measurement procedure should be explained or, if necessary, demonstrated,
prior to starting the measurement.
• The patient is always measured in a straight sitting position.
• He/she should keep his/her head straight or slightly extended.
• The nose-clip is put on the lower half of the nose.
• The patient should slightly bite on the mouthpiece (use tooth marker if
available!).
• Make sure that the patient carefully seals his/her lips around the
mouthpiece.
• The patient‘s tongue should be below the mouthpiece.
• Patients with dentures are examined while wearing the denture.
• Tongue piercings should be removed prior to the measurement.
Activities that should be avoided prior to starting a measurement:

• Smoking within at least 1 h of testing.
• Consuming alcohol within 4 h of testing.
• Performing vigorous exercise within 30 min of testing.
• Wearing clothing that substantially restricts full chest and abdominal
expansion.
• Eating a large meal within 2 h of testing.
Vyntus BODY/Vyntus BODY with Diffusion with USS module:

Connect the USS MicroGard adapter to the USS Module, then connect the
MicroGard filter to the USS MicroGard adapter. For bodyplethysmography and
diffusion measurements we recommend the use of mouthpieces with snorkel
shape to ensure optimal tightness.
To ensure optimal tongue placement, we recommend the use of the Free
Flow™ mouthpiece, if available.
For Vyntus BODY with USS module, the use of the MicroGard filter is
mandatory.
Please observe the “Basic Conditions prior to starting a Measurement“

and explain the whole measurement procedure to the patient before starting
the first measurement.
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Slow Spirometry
This measurement records a volume versus time curve. All diagnostically important
parameters of Slow Spirometry can be determined.
Start the measurement program by selecting <Spirometry> from the

“Applications”.
Perform a Slow Spirometry Measurement
The measurement is selected by clicking <Slow Spirometry>.
The measurement is started with <F1> “Start”.
Just before starting the measurement, the patient should close his/her nose
with the nose-clip, take the mouthpiece between his/her teeth and keep his/
her lips tightly around the mouthpiece. Check the correct position of the
mouthpiece!
On the screen the patient is instructed to

“Relax and breathe normally“.
The patient should breathe normally until stable tidal breathing is shown.
Steady tidal breathing is indicated by a red dashed line after at least five breaths.
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As soon as the system detects stable tidal breathing after a minimum of five
breaths, two vertical lines will automatically be set in the lower spirogram window
indicating the space to be filled by the breathing maneuver. In addition, the end
expiratory volume will be marked by a horizontal dashed line.
Recordings to the left of the first vertical line are used to determine the slow
spirometry parameters VT and BF.
Breathing for the slow vital capacity maneuver is limited to the space between
the vertical lines (30 s).
If the vertical lines are not displayed as the patient‘s tidal breathing is not stable
enough, it is also possible to mark the range for the maximum maneuver manually
with <F2> “Switch”.
Depending on the system setting, the slow vital capacity can be performed and
recorded as an ERV maneuver (see following screenshot) or as an IC maneuver.
ERV maneuver
Instruct the patient to slowly exhale to a maximum (ERV maneuver) until a
constant level is reached. Then the patient should slowly inhale (VC IN) and slowly
exhale to a maximum (VC EX). According to the ATS Guidelines the end-expiratory
level to be expected will be reached after 6 seconds.
After few normal breaths the breathing maneuver is complete.
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IC maneuver (setting IC, VC)

From normal breathing, the patient is instructed to inhale to a maximum (IC
maneuver) and to slowly exhale to a maximum (VC EX). According to the ATS
Guidelines the end-expiratory level to be expected will be reached after 6 seconds.
Then the patient is instructed to slowly inhale to a maximum (VC IN) and to
continue to breath normally.
Screen display of an ERV maneuver:
The left part of the chart section shows the recording of the volume-time curve.
The right part shows a lung animation of inhalation and exhalation and two bars
filling up during recording.
The upper bar indicator shows the exhalation time in seconds.

Recommendation: minimum 6 s.
The lower bar indicator shows the end-expiratory flow.
If the two bars are within the green range, the expiratory maneuver
has been performed correctly, which is additionally indicated by the
green checkmark as an “End of test“ criteria for the forced exhalation.
In the right middle window, the patient is given textual instructions for performing
the test. These instructions change depending on the type of maneuver.
Below these diagrams the measurement is displayed online as a spirogram.
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Click <F3> “Stop” to end the first trial.
Screen display after the first trial (Tr1):
The quality of the slow spirometry measurement depends on the patient‘s

cooperation. In order to assess reproducibility (repeatability) and thus the
quality of cooperation, it is recommended to perform at least 3 trials according
to the ATS/ERS guidelines.
Click <F1> “Start” to record another trial.
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Forced Spirometry
Forced Spirometry is one of the basic lung function tests. With various breathing
maneuvers during which the patient exhales as much and as fast as possible, the
ventilated lung volumes and the breathing flows are measured.
Results are represented in a flow-volume and a volume-time curve.
Perform a Forced Spirometry Measurement
The measurement is selected by clicking <Forced Spirometry>.
mouthpiece!

The patient breathes normally until a steady tidal breathing is shown. Steady tidal
breathing is indicated by a red dashed line after at least five breaths.
Depending on the system setting, an ERV or an IC maneuver can be performed

from normal breathing.
ERV maneuver
From normal breathing, the patient is instructed to exhale as deeply as possible
(ERV maneuver) and to inhale as deeply as possible (VC IN). Without interruption,
the patient should now immediately exhale as fast and as much (FEV1) and as long
(FVC) as possible. The maneuver is completed by several normal breaths.
IC maneuver
From tidal breathing, the patient is instructed to inhale as deeply as possible (IC
maneuver). Without interruption, the patient should now immediately exhale as
fast and as much (FEV1) and as long (FVC) as possible. The maneuver is usually
completed by a maximal inhalation (VC IN) and several normal breaths.
Please note: During the whole examination the patient must not leave the
mouthpiece.
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Screen display of an ERV maneuver:

The left part of the chart section shows the recording of the volume-time curve.
The right part shows a lung animation of inhalation and exhalation and two bars
filling up during recording.
The upper bar indicator shows the exhalation time in seconds.
According to the ATS/ERS guidelines: for adults 6 s and for children 3 s.
The lower bar indicator shows the end-expiratory flow.
If the two bars are within the green range, the expiratory maneuver
has been performed correctly, which is additionally indicated by the
green checkmark as an “End of test“ criteria for the forced exhalation.
In the right middle window, the patient is given textual instructions for performing
the test. These instructions change depending on the type of maneuver.
Below these diagrams the measurement is displayed online as a spirogram
(volume-time curve).
Version 01.00 • 2021-02-01 Page 49/170

Click <F3> “Stop” to end the first trial.
Screen display after the first trial (Tr1):
Predicted value range for Predicted value range

the expiratory for the volume-time trend
flow-volume curve
The quality of the flow-volume curve depends on the patient‘s cooperation. In

order to assess reproducibility (repeatability) and thus the quality of coopera-
tion, it is recommended to perform at least 3 trials according to the ATS/ERS
guidelines. The results of the best and the second best trial for FEV1 and FVC
may differ by ≤ 150 mL (or < 5 %).
For FVC ≤ 1 L a difference of ≤ 100 mL is valid*.
Press <F1> “Start” to perform another measurement.
* Literature:
- MR Miller et al. Series “ATS/ERS Task Force: Standardisation of Lung Function
Testing“, Standardisation of Spirometry, Eur Respir J 2005; 319-338
Copyright © ERS Journals Ltd. 2005
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Maximum Voluntary Ventilation (MVV)

The MVV is the maximum volume the patient can breathe within a predefined
period of time (usually 12 seconds). It is recorded as a volume versus time curve
which is displayed on the screen.
Perform an MVV Measurement
The measurement is selected by clicking <MVV>.
mouthpiece!

The patient should breathe normally. In this phase, at least five breaths are
required.
Just prior to the first vertical line being reached, the patient is instructed to
immediately inhale and exhale as fast and as deeply as possible.
Screen display during the measurement:
Version 01.00 • 2021-02-01 Page 51/170

The left part of the chart section shows the recording of the flow-volume curve.
The right part shows a lung animation of inhalation and exhalation and two
bar indicators showing the variation of the tidal volume (VT) and the breathing
frequency (BF).
In the bottom part of the chart section the patient is given textual instructions
for performing the test. These instructions change depending on the type of
maneuver.
Below these diagrams the measurement is displayed online as spirogram. The two
vertical lines mark the MVV measuring range (12 s).
After at least 12 seconds of maximal ventilation, the patient can

continue to breathe normally again and the measurement is ended.
If the patient hyperventilates for at least 6 seconds, the parameter MVV6 will be
available.
Screen display after the measurement:
Click <F1> “Start” to perform another measurement.
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Bodyplethysmography
The measurement program “Bodyplethysmography“ consists of three
measurement phases which allow a comprehensive analysis of the respiratory
mechanics of the lung.
In the first phase, important specific resistances (sReff, sRtot, ...) are determined
from the registered “breathing loops“. In the following second phase, the lung
volume (FRCpleth) is determined during an occlusion maneuver. The airway
resistances (Reff, Rtot, ...) will then automatically be calculated from those
parameters. If the FRCpleth occlusion measurement is “linked“ to a maximal
maneuver, important absolute lung volumes (RV, TLC) can be calculated as well.
The bodyplethysmography is usually be concluded with the third phase, in which
additional forced spirometry parameters (FEV1, FVC, FEFxx, ...) are determined.
Perform a Measurement
Measurement Sequence: Body Standard
sReff FRCpleth FRCpleth FRCpleth forced Spirometry forced Spirometry forced Spirometry
F1 F1 F1 F1 F2 & open door F1 F3
Start 1. Shutter maneuver 2. Shutter maneuver „Linked“ Maneuver 2. Forced Spirometry n. Forced Spirometry
Breathing loops „non-linked“ „non-linked“ FRCpleth + slow/forced Spirometry with door open
The number of non-linked shutter maneuvers

can be defined in the settings.
Note:
• The Breathing loops (sReff) should be recorded until they are reproducible. In this case, the spirogram
displays steady breathing.
• We recommend performing at least two “non-linked” FRCpleth measurements. The shutter is
activated with <F1> “Continue”.
• Now, any number of “linked maneuver” can be performed. We recommend to perform a FRCpleth
measurement combined with a forced spirometry maneuver. After the last volume determination
additional forced spirometry measurements can be performed.
• Switch to the measurement phase flow/volume curve with <F2> “Switch” and open the door.
• We recommend performing at least three forced spirometry measurements.
The measurement is selected by clicking <Body Standard>.
Version 01.00 • 2021-02-01 Page 53/170

Ask the patient to take a seat in the box (but not to approach the mouthpiece,
yet). The intercom system is activated automatically.
Door opener Inform the patient about the button to open the door from inside in case of
emergency.
Ask the patient to adapt to the mouthpiece and close the nose with the nose
clip. Instruct the patient to breathe normally.
Click <F7> to activate the door magnets.
Close the body box door.

Press the door against the magnets until the door is magnetically attracted and
closed.
The measurement can be started immediately.
Click <F1> “Start” to activate the measurement.

The on-screen instructions show “Relax and breathe normally“.
Once stable tidal breathing has been obtained, the earliest after four breaths, a
red dashed line representing FRC stability is drawn indicating the consistency of
the end-expiratory level.
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Expiration Inspiration
The last five (adjustable via the settings menu) loops of the specific resistance
(sReff) are shown on the left side of the screen. The spirogram appears in the
lower third of the screen. The right part of the screen shows three bars (indicators)
for evaluating the trial as well as a lung model. From top to bottom, the bars
indicate the stability (CV%) of the respiratory loops (sRaw), the stability of the tidal
volume (dVT) and the breathing frequency (BF).
Best results are obtained when the three bars are all in the green zone as
indicated above!
As soon as reproducible loops are shown and the spirogram displays regular
breathing (ideally with FRC stability), click <F1> “Continue“ to continue with
the volume measurement in which FRCpleth will be determined by an occlusion
maneuver.
After activation of the volume measurement, the shutter is closed at the end
of expiration.
Ask the patient to continue breathing normally even after the shutter is
closed.
Pulling or pressing against the shutter must not be forceful!
We recommend to perform at least 2 shutter maneuvers without a maximum

maneuver. The number of those “non-linked” maneuvers can be defined in the
settings. The default number is 2.
At least 2-3 tidal breaths should be performed between the closures.
Click <F1> „Continue“ to continue with the next closure (non-linked maneuver).
Screen display after two „non-linked“ FRC maneuvers:
FRCpleth curves first closure second closure

„non-linked“ „non-linked“
maneuver maneuver
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As soon as the non-linked maneuver is finished, click <F1> „Continue“ again to

start the first linked maneuver.
After a few normal breaths, instruct the patient to exhale to a maximum
through an ERV (expiratory reserve volume) or IC (inspiratory capacity) maneuver
(depending on the settings) until the spirogram shows a plateau and the patient
has reached his/her residual volume (RV). Then, the patient should inhale as fast
and as much as possible (VCIN), and without interruption exhale as fast and
as much as possible (FEV1, FVC). The maneuver is completed by a few normal
breaths.
first closure as „non-linked“

maneuver
second closure first closure as „linked“ maneuver with subsequent

as „non-linked“ maneuver forced spirometry
Criteria for forced spirometry measurements:

According to ATS/ERS Guidelines the patient should exhale for at least
6 seconds. The exhalation time is indicated by a bar (T EX) slowly filling up.
After an expiration period of 6 seconds or longer (green range), the minimum
ATS/ERS requirements have been met.
According to the ATS/ERS guidelines it is also important to motivate the patient
to try hard especially at the end of expiration in order to get optimal results.
The volume-time curve should change by less than 25 mL within one second,
which is indicated by the bar (dV) filled up to the green range.
End-of-test criterion for spirometry measurements:
When the patient exhales to a maximum, two bars slowly filling up are shown.
The upper bar indicator “T EX [s]“ shows the exhalation time in seconds.
6 seconds for adults and 3 seconds for children (if younger than 10 years) are
recommended. The lower bar indicator “dV [ml]“ shows the endexpiratory
flow and indicates when the expiratory plateau is reached.
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The two moving Stabilitrac bars should be in the green zone. A green
tick mark indicating „End of Test“ shows that the breathing maneuver
was performed correctly.
A red cross means criteria have not been met
FRCpleth criteria met:

If at least two comparable FRCpleth measurements (CV% < 10%) exist, a green
tick mark will appear.
If the previously performed FRCpleth measurements are not comparable yet, click
<F1> „Continue“ to start the next „linked“ maneuver.
Click <F2> “Switch“ perform additional, non-linked forced spirometry

measurements (flow-volume curve). Now, the cabin door should be opened.
Click <F7> to deactivate the door magnets. The door will open automatically.
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Third measurement phase - additional forced spirometry measurements
The quality of the flow/volume curve highly depends on the patient‘s

co-operation. In order to determine the repeatability and the quality of the co-
operation, it is recommended that you perform at least three trials.
After each flow-volume curve, <F1> NEEDS to be pressed. Otherwise, the

various flow-volume curves will not be recorded.
first closure as
„non-linked“ maneuver
second forced third forced
second closure as spirometry spirometry
„non-linked“ maneuver
first closure as „linked“ maneuver

with subsequent forced spirometry
<F3> “Stop“ ends the measurement.
Open the door, if not already done.
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Result display:
View of the Spirograms
View of the Flow-Volume loops
View of the Resistance-Volume graph
The best trial of all trials is automatically calculated and displayed on the
screen. The best curve is always represented in black.
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Diffusion SB Realtime
The measurement program “Diffusion Realtime“ allows the determination of the
diffusion capacity (DLCO-SB) and the alveolar volume (VA) using the single-breath
method (SB). It also allows the determination of additional parameters such as
the Krogh factor (KCO) and the absolute volumes (TLC-SB, FRC-SB, and RV-SB).
Realtime means that the concentration of the test gases is already recorded in the
mouth during the measurement because of quick gas analyzers.
This is only a brief description of the measurement. The associated Online

Manual contains a detailed description.
Preparing for a Measurement

Prior to every measurement the device configuration must be
checked:
• Is the drying tube connected to the analyzer unit and USS MicroGard
Adapter for gas sampling?
• Is the FPV silicone valve connected to the FPV (Flow Path Valve) block?
• Is the cylinder valve of the diffusion gas cylinder (CO/CH4) open and is the
remaining pressure of the gas cylinder indicated on the manometer at
least 10 bars?
• Have a gas calibration (CO/CH4) and a volume verification been
performed?
Vyntus BODY with Diffusion in the corner:
Analyzer unit
FPV (Flow Path Valve) USS MicroGard
block Adapter for gas
sampling
MicroGard
filter
Demand valve
FPV silicone valve USS module
Housing
Clamp
Drying tube for gas
analysis
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Vyntus BODY with Diffusion in the ceiling:
Housing for gas ports
USS MicroGard
Adapter for gas
sampling
MicroGard
filter
Demand valve
FPV silicone valve USS module
Drying tube for gas

analysis
Housing
Clamp
FPV (Flow Path Valve)

block
The diffusion capacity is distorted by the following factors:
• Smoking on the day of the measurement - the CO absorption during smoking

produces a so-called CO back pressure which is not allowed.
• O2 administration within 10 min of testing.
• Consuming alcohol on the day of the measurement.
The chapter “General Safety Precautions“ of the enclosed Instructions

for Use includes additional important information on the safe han-
dling of gases and must be absolutely observed.
Version 01.00 • 2021-02-01 Page 61/170

Perform a Diffusion SB Realtime Measurement

The measurement is selected by clicking <Diffusion SB Realtime>.
The measurement is started by clicking <F1> “Start”.
A zero adjustment of the sensors is automatically performed.
mouthpiece!
The patient needs to breathe normally until an even tidal breathing has been
obtained. Once FRC stability has been reached - no earlier than after 4 breaths
- a red dashed line will be drawn on the screen indicating consistency of the
endexpiratory level.
FRC stability line
Ask the patient to exhale as deeply as possible to initiate the single-breath

maneuver.
Click <F1> “Maneuver” during expiration.
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<F1> “Maneuver” should only be pressed once the patient is actually in the
deep expiration phase; however, <F1> “Maneuver” should not be pressed
too late in the maneuver as the system requires a reaction time to release the
measurement gas.
As soon as the residual volume (RV) has been reached after the maximal
exhalation, the patient is asked to inhale quickly to the maximum (VIN) until he or
she reaches his or her total lung capacity (TLC).
At that moment the flap valve is closed automatically.
The current ATS/ERS standards for the determination of the diffusion capac-
ity*1 require a rapid inhalation to TLC, where 85% of VIN must be inspired in
< 4.0 sec. and VIN is at least 90% of VCmax.
During the inspiration the patient inhales single-breath diffusion gas

(0.3 % CO, 0.3 % CH4, 0.3 % C2H2 (optional), 21 % O2, rest N2).
The horizontal lines plotted in the “Spirogram and Mouth pressure“ window (see
image below) have the following meaning:
continuous line indicates the inspiratory volume.
If a spirometry measurement has been performed
prior to the examination, the window shows the VIN
best value which was measured. If there is no VIN
value available during the examination, the predicted
value is displayed.
dashed line indicates the inspiratory volume at 90 %
(adjustable) of the patient related best value
According to the ERS/ATS 2017 standards*1 the patient should inhale at least
90 % of the VIN. Alternatively, a VIN ≥ 85% of VCMAX is acceptable if the
VA of the trial is within 200 ml or 5% (whichever is greater) of the largest VA
from another acceptable trial.
Depending on the preset calculation method (preset: Jones-Meade 70 %),

different parts of the inspiration time are added to the occlusion time.
The breath holding time should last 10 ± 2 seconds according to the current ATS/
ERS*1 recommendations. Normally, the time is 10 seconds. This value can be
adjusted in the settings.
The variability of the measurement is increased if the patient does

not relax during the occlusion but performs inspiratory (Müller) or
expiratory (Valsalva) efforts.
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The right chart displays the remaining breath hold time. It gives the operator an
indication of how much longer the shutter occlusion will last.
Furthermore, the mouth pressure during the breath hold time is recorded. The
objective is to keep the mouth pressure in the green range, i.e. the patient should
be relaxed during the breath hold maneuver and should not perform inspiratory or
expiratory efforts against the shutter.
*1: 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
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During the breath hold time the inhaled single-breath gas mixture is evenly
distributed throughout the lungs and the CO gas diffuses into the blood via
the alveolocapillary membrane.
Existing distribution disorders of the lungs influence the CO gas distribution in
the alveolar gas space.
After the preset breath holding time has expired, the shutter opens automatically.
The patient is required to exhale quickly and completely without hesitation.
In the case of very small vital capacities, the sample volume (SV) is rescaled
automatically.
Below the spirogram the displayed pressure channel (red) shows possible breathing
efforts of the patient against the shutter. If there is any higher expiratory or
inspiratory pressure, the diffusion measurement can be influenced. The patient
should be made aware to keep pressure as neutral as possible during the breath
hold. Afterwards the measurement should be repeated.
Discard volume (DV) and sample volume (SV) are adjusted according to the
setting. The analysis of the measured gas concentration takes place in the area
of the sample volume. The parameters are calculated fully automatically.
According to the ERS/ATS 2017 standards*1 ,VA can be calculated using the
mass balance equation on the complete exhalation of the tracer gas CH4. If
the setting “mass balance” is enabled, the alveolar volume (VA_EX) will be
calculated based on the exhaled CH4 (FACH4end).
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Screen display after first trial:
According to ERS/ATS 2017 standards*1 at least two acceptable trials (Grade A)

should be performed in order to ensure reproducibility.
According to the ERS/ATS 2005 standards a minimum pause of at least four

minutes between two trials should be kept to allow the test gas in the lungs
to be washed out. In patients with airflow obstruction, a longer period (e.g.
10 min) should be considered.
More than 5 tests altogether should not be performed
If the setting for quality criterion is set to „ERS/ATS 2017“ the four minutes wait-
ing time can be skipped and the user can decide by themselves how long the
patient should wait between the trials. According the „ERS/ATS 2017“ standard
the SentrySuite software has an algorithm implemented to recognize if the patient
is enough washed out or not. The following warning message will appear earliest
with the second trial during the tidal breathing phase if the patients wasn‘t suf-
ficiently washed out.
Please observe the safety notes on CO toxicity in the enclosed Instructions for
Use.
Click <F4> “Edit” to edit or deactivate trials or to enter the value for hemoglobin.
For more detailed information please refer to the Online Manual.
The cylinder valves are to be closed as soon as the work is interrupted or

finished!
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Diffusion SB Intrabreath
The measurement program “Diffusion SB Intrabreath“ allows the determination
of the diffusion capacity (DLCO IB) and the alveolar volume (VA) using the
intrabreath method (IB). It also allows the determination of additional parameters
as the Krogh factor (KCO IB) and the absolute volumes (TLC-IB, FRC-IB, and RV).
Intrabreath means that the maximal inspiration is followed by a slow and even
expiration to the maximum. Thus, a breath-holding time is not necessary.
Prior to every measurement the device configuration must be

checked:
• Is the drying tube connected to the analyzer unit and USS MicroGard
Adapter for gas sampling?
• Is the FPV silicone valve connected to the FPV (Flow Path Valve) block?
• Is the cylinder valve of the diffusion gas cylinder (CO/CH4) open and is the
remaining pressure of the gas cylinder indicated on the manometer at
least 10 bars?
• Have a gas calibration (CO/CH4) and a volume verification been
performed?
Vyntus BODY with Diffusion in the corner:

Analyzer unit
USS MicroGard
Adapter for gas
sampling
MicroGard
filter
Demand valve
USS module
FPV silicone valve
Drying tube for gas

analysis
Housing
Clamp
block
Version 01.00 • 2021-02-01 Page 67/170

Vyntus BODY with Diffusion in the ceiling:
USS MicroGard
Adapter for gas
sampling
MicroGard
filter
Demand valve
USS module
FPV silicone valve
Drying tube for gas

analysis
Housing
Clamp
block
Page 68/170 Version 01.00 • 2021-02-01

The diffusion capacity is distorted by the following factors:
• Smoking on the day of the measurement - the CO absorption during smoking

produces a so-called CO backpressure which is not allowed.
• O2 administration within 10 min of testing.
• Consuming alcohol on the day of the measurement.
The chapter “General Safety Precautions“ of the enclosed Instructions

for Use includes additional important information on the safe
handling of gases and must be absolutely observed.
Perform a Diffusion SB Intrabreath Measurement
The measurement is selected by clicking <Diffusion SB Intrabreath>.
A zero adjustment of the sensors is automatically performed.
mouthpiece!
The patient has to breathe normally until he or she has reached an even tidal
breathing. As soon as there is a FRC stability, yet at the earliest after 4 breaths, a
red dashed line indicating the end expiratory volume appears.
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FRC stability line
Ask the patient to exhale as deeply as possible to initiate the intrabreath

maneuver.
Click <F1> “Manoeuver” during expiration.
<F1> “Maneuver” should only be pressed once the patient is actually in the
deep expiration phase; however, <F1> “Maneuver” should not be pressed
too late in the maneuver as the system requires a reaction time to release the
measurement gas.
As soon as the residual volume (RV) is reached after the maximal expiration,
the patient is required to inhale quickly and maximally (VIN) until he or she has
reached his or her total lung capacity (TLC).
The current ATS/ERS standards for the determination of the diffusion capac-
ity*1 require a quick inspiration which is completed in less than 4 seconds.
During the inspiration the patient inhales single-breath diffusion gas

(0.3 % CO, 0.3 % CH4, 0.3 % C2H2 (optional), 21 % O2, rest N2).
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The horizontal (gray) lines plotted in the “Spirogram & Flow“ window have the
following meaning:
continuous line indicates the patient-related inspiratory vital capacity
If a spirometry measurement has been performed
prior to the examination, the window shows the VIN
value of the patient which was actually measured.
If there is no VIN value available during the
examination, the predicted value is displayed.
dashed line indicates the patient-related inspiratory vital capacity
at 85 % (adjustable).
According to the ATS guidelines*1 the patient should inhale at least 85 % of

the VIN.
*1 N. MacIntyre et al. Standardisation of the single-breath determination of carbon

monoxide uptake in the lung.
Series “ATS/ERS Task Force: Standardisation of lung function testing“
EUR Respir J 2005; 26: 720-735
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After the maximal inspiration, ask the patient to expire slowly and evenly
(important!) to maximum expiration. Make sure that the flow during expira-
tion is between 0.3 L/s and 0.7 L/s.
The gray bar indicates the range in which the expiration flow should be
(0.3 - 0.7 L/s). It is the aim to reach an even expiration with a constant flow, i.e.
the red flow curve should run horizontally within the grey range.
The inhaled gas mixture is evenly distributed throughout the lungs and the
CO diffuses into the blood via the capillary membrane. Existing distribution
disorders of the lungs influence the CO gas distribution in the alveolar gas
space and therefore influence the result of the diffusion measurement.
The measured gas concentration of the sample volume is analyzed and the
results will be calculated automatically.
After maximal expiration, the patient can leave the mouthpiece.
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Screen display after the first measurement:
According to ATS 1995 and ATS/ERS 2005 regulations at least two trials should be
performed in order to ensure reproducibility.
A minimum pause of four minutes between two trials should be

kept to allow the test gas in the lungs to be washed out and the “CO
back pressure“ in the blood to dissipate. More than 5 tests altogether
should not be performed.
Please observe the safety notes on CO toxicity in the enclosed

Instructions for Use.
Click <F4> “Edit” to edit or deactivate trials or to enter the value for hemoglobin.
For more detailed information please refer to the Online Manual.
Note: The shown green C2H2 curves to calculate cardiac output in the screen shots
are possible with the device Vyntus ONE only but are not part of the device Vyntus
BODY with diffusion.
Version 01.00 • 2021-02-01 Page 73/170

R Occlusion (Option)
The measurement program “R Occlusion“ allows to perform an airway
resistance measurement according to the shutter or shutter pressure method. The
measurement only requires tidal breathing, therefore “R Occ“ can be determined
almost independently of patient cooperation.
Perform an R Occlusion Measurement
The measurement is selected by clicking <R Occlusion>.
mouthpiece!
On the screen the patient is instructed to “Relax and breathe normally“.
Instruct the patient to inhale and exhale as normal tidal breathing.

With every other expiratory maneuvre the shutter will automatically close and
occlude the patient‘s breath for 100 ms. Each occlusion is one trial. 10 trials can be
saved. If the 11th trial occurs, the trial with the highest coefficient of variation (CV)
will disappear.
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In the left part of the chart section the shutter pressure curve and the trend curve
are displayed.
The right part shows a lung animation of inhalation and exhalation and the
occlusion is graphically displayed.
The two bar indicators show the variation of the airway resistance (R Occ) in
percent and the breathing frequency (BF).
In the bottom part of the chart section the patient is given textual instructions
for performing the test.
Below these diagrams the measurement is displayed online as a spirogram.
Version 01.00 • 2021-02-01 Page 75/170

Click <F3> “Stop” to end the trial.
Click <F1> “Start” to perform another measurement.
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Respiratory Drive P 0.1

The measurement program “P 0.1“ allows the operator to measure the respiratory
drive by means of a mouth occlusion pressure measurement. The measurement
only requires tidal breathing, therefore “P 0.1“ can be determined almost
independently of patient cooperation.
Perform a P 0.1 Measurement
The measurement is selected by clicking <P 0.1 Rest>.
Click <F1> “Start” to start the measurement.
mouthpiece!
On the screen the patient is instructed to “Relax and breathe normal”.
At the earliest after five breaths a red dashed line appears indicating an even tidal
breathing. As soon as the system has recognized an even tidal breathing, click on
<F1> “Start” to start the maneuver.
Please explain the maneuver to the patient:
Instruct the patient to inhale and exhale calmly and evenly.
At the start of an inspiration the shutter will automatically close and after 0.1
seconds the inspiratory mouth pressure “P0.1“ is measured. The shutter only
closes for a fraction of a second and does not hamper the patient‘s breathing.
In subsequent measurements the shutter is not set to close with each breath, but
irregularly (random number generator) in order to avoid reactions of the patient.
In order to obtain precise measurement results several occlusions should be
performed during one trial. At least 5 occlusions per trial are recommended and
preset.
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Shutter
FRC stability line
The left part of the operator area shows the recording of the pressure-time curve
and underneath the current trend graph. The right part shows a lung model giving
a graphic display of inspiration and expiration as well as two bars indicating the
regularity of breathing and the breathing frequency (BF).
Ideally the two bars are within the green range as shown above.
Expiration Inspiration
In the bottom part of this area the breathing maneuver is displayed as a volume-
time curve.
Click <F3> “Stop” to end the trial.
In order to determine the reproducibility and the quality of the cooperation it is

recommended to perform at least three trials.
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Click <F1> “Start” to start another measurement.
Screen display after four trials:
The parameters shown in the Best column represent the mean value
(median) of all performed trials.
The curve which comes closest to the mean value (median) is displayed in black.
Version 01.00 • 2021-02-01 Page 79/170

MIP / MEP
The “MIP / MEP“ program allows the measurement of the maximal inspiratory
and expiratory mouth pressure. The measured pressure values are taken for
assessing respiratory muscle strength.
Perform a MIP / MEP Measurement

The different measurements can be selected and performed individually from each
other.
MIP = maximum inspiratory mouth pressure
MEP = maximum expiratory mouth pressure
MIP Measurement
The measurement is selected by clicking <MIP>.

Click <F1> “Start“ to start the measurement.
mouthpiece!
On the screen the patient is instructed to “Relax and breathe normally”.
Page 80/170 Version 01.00 • 2021-02-01

breathing. As soon as the system has recognized an even tidal breathing, the
patient is instructed to exhale deeply.
FRC stability line
During expiration, press <F1> “Continue” to start the maneuver.
Do not click <F1> “Continue” until it is visible that the patient is actually
exhaling deeply.
After a deep expiration, the patient is asked to breathe in as fast and strongly
as possible against the closed shutter and to maintain the pressure for at least
2 seconds.
As this breathing maneuver strongly depends on the patient‘s cooperation,

several trials should be performed.
For another trial ask the patient to continue to breathe normally until the red
dashed line appears indicating an even tidal breathing.
Now the maneuver can be repeated by clicking <F1> “Continue” while the
patient is breathing out deeply again.
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Screen display after 5 trials:
By clicking <F2> “Switch” a subsequent MEP measurement could be started.

However, in this manual the MEP measurement is described individually (see
“MEP Measurement”).
Click <F3> “Stop” to end the MIP measurement.
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Screen display after the MIP measurement:
The central screen displays the pressure-time curve on the left hand side and below
that window the trend graph of each trial of the MIP measurement.
The lower section displays the quality assessment.
The parameters shown in the Best column represent the highest measured values
from all trials.
All in all, 10 trials can be performed and saved. If an 11th trial is performed,
the trial with the lowermost value is overwritten.
Version 01.00 • 2021-02-01 Page 83/170

MEP Measurement
The measurement can either be called up directly after the MIP measurement or by
selecting <MEP>.
mouthpiece!
On the screen the patient is instructed to “Relax and breathe normally”.
breathing. As soon as the system has recognized an even tidal breathing, the
patient is instructed to inhale deeply.
FRC stability line
During inspiration, press <F1> “Continue” to start the maneuver.
Do not click <F1> “Continue” until it is visible that the patient is actually
inhaling deeply.
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After a deep inspiration, the patient is asked to breathe out as fast and
strongly as possible against the closed shutter and to maintain the pressure for
at least 2 seconds.
As this breathing maneuver strongly depends on the patient‘s cooperation,

several trials should be performed.
For another trial ask the patient to continue to breathe normally until the red
dashed line appears indicating an even tidal breathing. Now the maneuver can be
repeated by clicking <F1> “Continue” while the patient is breathing in deeply
again.
Click <F3> “Stop” to end the measurement.
Screen display after 5 MIP and 5 MEP measurements:
The central screen displays the pressure-time curve on the right hand side and
below that window the trend graph of each trial of the MEP measurement.
The lower section displays the quality assessment.
The parameters shown in the Best column represent the highest measured values
from all trials.
All in all, 10 trials can be performed and saved. If an 11th trial is performed,
the trial with the lowermost value is overwritten.
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SNIP (Option)
The “SNIP“ program (SNIP = Sniff Nasal Inspiratory Pressure) allows the non-
invasive measurement of the inspiratory muscle strength.
Perform a SNIP Measurement

1. Attach the pressure tube to the connection nipple located at the right side of
the FPV Control Unit.
2. Attach a new nasal plug to the pressure tube.
3. Put the nasal plug into a nostril.
If one nostril is congested, put the nasal plug into the

contralateral nostril.
4. Make sure that the nose plug occludes the respective nostril pressure-tight. If
necessary, replace the nasal plug with another size to customize the fit.
Nasal plug
(single use item)
FPV Control Unit
Connection nipple
Pressure tube
The measurement is selected by clicking <SNIP>.
Just before starting the measurement, the patient should breathe normally
with his/her mouth closed. Check the correct position of the nasal plug!
Please explain the maneuver to the patient:

The patient is asked to perform a short, sharp and maximum sniff from normal
breathing.
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As soon as the first snip maneuver is recognized, the countdown timer starts to
count down 30 seconds. It is recommended* to observe a resting period of 15-30
seconds until the next trial is started via <F1> “Start“. Usually, one maneuver per
trial is sufficient.
Further maneuvers can be performed within a trial at any time and as often as
required. With each recording of a snip maneuver the countdown timer is reset to
its initial value of 30 s.
Only the best maneuver of a trial will be saved.
Ideally, the grey bar is within the green range as shown below.
Best sniff curve of Screen display during the measurement:

the current trial
Currently measured sniff curve
of the current trial
Remaining
waiting time
between each
sniff
Countdown
Timer
currently
measured
value in %
of predicted
value
previous best
value of the
current trial in
% of predict-
ed value
100 % Pred
Pressure/Time
curve of all
maneuvers of
the current
trial
Best values of the

different trials * Reference:
Nikoletou, Dimitra et al. Sniff Nasal Inspiratory Pressure in Patients with Moderate-
to-Severe Chronic Obstructive Pulmonary Disease: Learning Effect and Short-Term
Between-Session Repeatability. Respiration 2014; 88: 365-370.
Terzi, Nicolas et al. Mouth and Nasal Inspiratory Pressure: Learning Effect and
Reproducibility in Healthy Adults. Respiration 2010; 80: 379-386.
Version 01.00 • 2021-02-01 Page 87/170

Click <F1> “Start” to start another trial.
In order to ensure high measuring accuracy, at least 5-7 trials should be recorded.
Optimal collaboration is indicated by a plateau of the recent measurements’ SNIP
peak values.
The best maneuver of the first trial is automatically displayed as a colored bullet in
the middle window on the left.
All in all, 10 trials can be saved. If further trials are performed, the trial with the
so far lowermost value will be replaced.
Click <F3> “Stop“ to stop the measurement.
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Compliance (Option)
This program measures dynamic and/or static compliance from the esophagus
pressure-volume curve. The compliance is measured in the esophagus because this
pressure is approximately the same as the thoracic (pleural) pressure. Compliance
is the reciprocal value for the elasticity of the lung tissue. The measurement of the
dynamic compliance takes place during tidal breathing (not dependent on patient
cooperation). The measurement of the static compliance can be carried out over
the whole range of vital capacity.
The catheter can be used for children older than 10 years and for adults.

1. Unpack the Compliance Kit consisting of:
Connection tube with

imprinted length marking Transparent
connection tube
Adapter Adapter for catheter

connection
Luer-Lock adapter with

Esophagus catheter
3-Way-Stopcock
Version 01.00 • 2021-02-01 Page 89/170

2. Connect the blue adapter to the adapter of the catheter with a rotary
movement.
3. Set the 3-Way-Stopcock in the „open“ position.
“open” position
4. In order to remove the air, put two thirds of the catheter into a jar filled with
water. As soon as the air is removed, set the 3-Way-Stopcock in the „closed“
position.
“closed” position
Then, take the catheter out of the water.
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Insertion of the Esophagus Catheter

We recommend the following procedure:
1. Spray a local anesthetic onto the catheter balloon.
2. Rotate the catheter slightly during carefully inserting it via the inferior nasal
concha until the epiglottis is reached.
3. Give the patient a glass of water and a straw and ask him to lower his head
(chin on chest). The patient shall drink and swallow and at the same time the
catheter is carefully introduced further. The swallowing movement helps to
transport the balloon and the liquid helps to overcome the irritation more
easily.
4. The correct position is reached as soon as the catheter is placed directly before
the cardia (entrance to stomach).
Pneumotach
Esophagus catheter
Lung
Heart
Esophagus balloon
Diaphragm
A scale with length specification is imprinted on the catheter. In order to initially

determine an appropriate position of the catheter, the body height of the patient
can be used.
Length inserted [cm] = approximately 0.25 x body height [cm]
The average distance between cardia and nose opening of a person of average
height (about 1.80 m) is approx. 42 cm.
5. Wait 2 to 3 minutes until peristalsis and the stimulus caused by the foreign
body eases off.
6. Connect the catheter to the measuring system (see next page).
7. Pressures taken through the “Y” connector are for balloon placement only. The
stylet, luer cap and „Y“ connector are bonded into a single unit and must be
removed from the catheter before taking pressure measurements for clinical
purposes.
Once the catheter has been positioned properly, disconnect the extension tube
from the stylet „Y“ connector and remove the stylet assembly from the
catheter.
Of course, other methods can be applied as well. The method described above
is only one of many examples.
Version 01.00 • 2021-02-01 Page 91/170

Adaption of the Esophagus Catheter to the

Measuring System
The pressure transducer needed for the compliance measurement is located at the
backside of the Control Unit FPV eDemand.
Connect the esophagus catheter tube to the measuring system

(see image below). Set the 3-Way-Stopcock in the position shown
and fill in 1 mL air by means of a syringe (see image on the left
hand). Finally, set the 3-Way-Stopcock in the „open“ position.
“open” position
Pressure transducer
„Connection nipple“
Esophagus catheter
FPV Control Unit
Connection to the pressure transducer

The Luer-Lock adapter is connected to the smaller silicone tube (smaller diameter). The
open side of the silicone tube then fits exactly to the nipple of the pressure transducer
located at the right side of the FPV Control Unit.
The Luer-Lock adapter allows the connection to the esophagus balloon catheter kit.
It is recommended to place the 3-Way-Stopcock between the extension tube of the
catheter kit and the Luer-Lock adapter.
Perform a Compliance Measurement

There are two different measurement programs available: “Dynamic
Compliance“ and “Static Compliance“. Both programs will be described in the
following.
Usually, the measurement is started with the dynamic compliance. Click

<Dynamic Compliance> to activate the measurement.
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Catheter Positioning
Just before starting the measurement, close off the patient‘s nose with the
nose-clip. The patient should take the mouthpiece between his/her teeth and
keep his/her lips tightly around the mouthpiece. Check the correct position of
the mouthpiece! In order to avoid shifting of the catheter towards the stomach,
secure the catheter to prevent it from moving.
On the screen, the patient is instructed to „Relax and breathe normally“.

Ask the patient to inhale and exhale slowly and evenly.
Click<F1> „Start“ to start the catheter positioning.
Screen display:
The window „Spirogramm“ records the curves for volume and transpleural pres-
sure (Ptp) against the time. Both signals should be synchronous. If a signal shift is
noticed, the esophagus balloon is located in the stomach and needs to be pulled
back slightly. Short and regular pressure deflections of the Ptp signal indicate the
influence of the heart beat; usually, they can be reduced to a minimum by moving
the catheter a little deeper.
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The window „Guidance & Stabilitrac“ shows the transpleural pressure. Ideally, the
bar should be in the green range.
If the value of the transpleural pressure is positive, an orange arrow up appears

indicating that the catheter should be moved upwards or slightly pulled out.
If the transpleural pressure is below -0,5 kPa, a blue arrow down appears indicat-
ing that the catheter should be slightly moved downwards.
Strong, irregular pressure changes show a strong oesophageal reaction. This

reaction normally disappears as soon as the patient gets used to the balloon
catheter.
General notes on catheter positioning:

Within the first minutes of the measurement irregular fluctuations can
generally be observed on the pressure axis. These fluctuations are caused
by the catheter (foreign body) which is moved by the peristalsis. If the curve
approaches the positive pressure range, the catheter is to be pulled out
somewhat (approx. -0,5 kPa).
Strong cardiogenic pressure artifacts are caused by a balloon which is not
introduced far enough. If the balloon is introduced into the stomach past the
cardia, there will be a clearly positive pressure during inhalation.
The best position for the catheter will be reached if a negative pressure of
approx. -0.5 kPa is displayed at the beginning of inspiration.
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Click <F1> to start the dynamic compliance measurement.
Ask the patient to continue breathing slowly and evenly.
The upper left window shows the curves of the dynamic compliance in a volume/
pressure (-Ptp) display. The curves should be egg-shaped, slightly tilted and run
counterclockwise. The more they tile the smaller the dynamic compliance and the
less flexible are the lungs.
The upper left window shows the curves of volume and transpleural pressure (Ptp)
related to the time. Both signals should be synchronous. If this is not the case,
refer to chapter „Catheter Positioning“ for more information.
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After a few breaths, the trial is ended automatically and is indicated in the
„Trend“ window as a colored bullet. At the same time, the next trial is started
automatically. The patient is asked to continue breathing slowly and evenly.
The window „Guidance & Stabilitrac“ shows the stability of the dynamic
compliance (d Cdyn) as well as the breathing frequency (BF). Ideally, the respective
bars should be in the green range.
In order to increase measuring accuracy, several trials should be successively
performed.
If the „Trend“ window shows a plateau of the measurement values, you can
switch to the measurement of the static compliance.
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Click <F2> to switch to the static compliance measurement. At the same time,
the measurement is started automatically.
Initially, the patient should continue to breathe slowly and evenly.
As soon as the instruction „Inhale as deeply as possible...“ appears, the patient

is asked to inhale as deeply as possible, to briefly hold his/her breath (otherwise,
artifacts may occur) and then to slowly exhale.
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The upper left window shows the curve of the static compliance online in a vol-
ume/pressure display. The curve should be „S“-shaped and slightly tilted. The more
they tile, the smaller the static compliance and the less flexible are the lungs.
The lower window shows the curves for volume and transpleural pressure (Ptp)
against the time. Both signals should be synchronous. If this is not the case, refer
to chapter „Catheter Positioning“ for more information.
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Click <F1> to end the first trial. The next trial is started automatically.
In order to increase measurement accuracy, several trials should be performed

successively.
Click <F3> „Stop“ to end the measurement.
Result screen:
Best = Best value, determined from the median of all valid trials
The left graphic window displays the dynamic The right graphic window displays the static
compliance curves of all trials overlayed. The compliance curves of all trials overlayed. The
best trial is displayed as a black curve. best trial is displayed as a black curve.
The trend is displayed below. The trend is displayed below.
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Rhinomanometry (Option)
The measurement program „Rhinomanometry“ allows the measurement and
evaluation of the ventilatory function of the nose.
Preparing for the Measurement

Before starting the measurement, connect all parts as shown below.
USS Module
MicroGard II C Filter
Cone adapter
FPV Controll Unit
Connection nipple
Measuring hose for choanal

pressure
Face mask
tube adapter
Nasal plug
Cone adapter
Tube adapter
Hose to connect on the
FPV Control Unit
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Perform a measurement
The measurement program is selected with <Rhinomanometry>.
As depicted, the patient’s right nostril is occluded using the nasal plug. The left
nostril will be measured.
Make sure that the nasal plug occludes the respective nostril pressure-tight but
does not deform it too much. If necessary, replace the nasal plug with another
size to customize the fit.
Ask the patient to place his/her hands around the face mask and to press it against
his/her face.
Make sure that the face mask fits tightly but does not deform the nose
and that the pressure hose located inside the mask is not bent. Ask the
patient to regularly breathe in and out through the open nostril 3 to 5
times per trial while keeping the mouth closed tightly.
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Click <F1> to start the first trial.
Screen display during the first trial:
The left upper window displaying the ”Flow/Pressure“ graph successively shows
the flow-pressure curve of those breaths performed within the trial as a grey curve.
The bottom window ”Spirogram“ displays the individual breaths against the time.
The “Guidance & Stabilitrac“ window on the right incorporates two bars. The
upper bar indicates the stability of the tidal volume VT. The lower bar indicates the
breathing frequency BF recorded during normal breathing. The animation shows
the correct position of the nasal plug as well. The side of the nostril which is not
occluded is measured.
Ideally, a regular tidal breathing is reached, i.e. dVT ≤ 10% and

BF=constant. A green check mark indicates the validity of the trial.
After 3 - 5 recorded breaths, the trial is terminated by clicking <F1> „Present“.

The measurement results of the first trial are displayed on the screen.
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Before starting another trial, the patient should briefly leave the mask
to avoid dyspnea. Breathing freely through the mouth creates the pre-
requisite for an optimal next trial.
Record further trials as described above. Each new trial is started via <F1> “Start”
and ended via <F1> “Present”.
The trend graph shows the trend information for flow or resistance depending on
the settings. The presentation of the inspiratory flow is recommended.
Normal range The dashed line indicates

the predicted value
left side of the nose
right side of the nose
The measurement of the first side of the nose can be terminated if the test
results show a plateau.
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The measurement of the left nostril is ended via <F3> “Stop”.
Click <F2> “Switch“ to change the side of the nose:
Click <F1> „Start“ to enter the measurement screen.
The patient’s left nostril is occluded using the nasal plug. The right nostril will
be measured.
Click <F1> „Start“ to start the measurement and click <F1> “Present” to end
the trial. Perform several trials as described above.
Click <F3> „Stop“ to terminate the measurement.
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Result screen:
The parameter table presents the predicted value calculated from the patient data
as well as the best values which are the final results of the test and the recorded
values of all valid trials.
Best = Best value, determined from the median of all valid trials
The left graphic window displays the The right window shows the flow
flow-pressure graphs of all trials (left and and resistance trend of all valid
right side of the nose) superimposed. The trials (left and right side of the
respective best trial for the left and for the nose).
right nostril is displayed as a black curve.
left nostril
right nostril
Click <F1> „Start“ to start another measurement.
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Set Visit Levels

(Perform a Post Measurement)
“Level“ stands for the type of measurement performed.

Pre = measurement before bronchodilation or measurement without follow-up
measurement
Post = measurement after bronchodilation
Test = measurement without any further definition
It is recommended to use the preset level “Pre“ for the first measurement of a
visit.
The “Pre“ level allows to perform up to 10 trials.
Post measurement in the “Post“ level

For the post measurement select the “New Post“ level.
Click “Pre“ and “New Post“.
Now, the post measurement can be performed, e.g. after administering a

bronchodilator. The “New Post“ level also allows to perform up to 10 trials.
Should additional post measurements be performed, “New Post“ can be selected

again.
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Quality Assessment/Interpretation/Comments
In all measurement programs there are different tabs in the lower part of the
screen:
- Guidance
- Quality
- Auto Interpretation
- Interpretation/Comments
Quality Assessment
When clicking the “Quality“ tab, the quality assessment result according to
the recommendations of “ATS and ERS 2005“ is indicated for the performed
measurement.
On the right, the result of the quality control

is summarized in a graphical display.
Auto Interpretation
When clicking the “Auto Interpretation“ tab, the automatic interpretation is
displayed as a text on the left hand side of the screen.
On the right, the classification of the mea-

surement according to the ATS/ERS recom-
mendations is indicated as a bar diagram.
Clicking the down arrow opens a list of interpretation modules. The measurement
program saves the selected module as the standard module for the next
examination.
Literature: Eur Respir J 2005; 319-338, DOI: 10. 1183/09031936.05.00034805

*1
Copyright ©ERS Journals Ltd. 2005
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Slow Spirometry classification is based on Vital Capacity (VC MAX):

Very Severe = VC MAX < 35 % Pred
Severe = VC MAX 35 % to 49 % Pred
Moderate Severe = VC MAX 50 % to 59 % Pred
Moderate = VC MAX 60 % to 69 % Pred
Mild/Normal = VC MAX ≥ 70 % Pred
Forced Spirometry classification is based on FEV1*:

Very Severe = FEV1 < 35 % Pred
Severe = FEV1 35 % to 49 % Pred
Moderate Severe = FEV1 50 % to 59 % Pred
Moderate = FEV1 60 % to 69 % Pred
Mild/Normal = FEV1 ≥ 70 % Pred
MVV classification is based on MVV:

Very Severe = MVV < 35 % Pred
Severe = MVV 35 % to 49 % Pred
Moderate Severe = MVV 50 % to 59 % Pred
Moderate = MVV 60 % to 69 % Pred
Mild/Normal = MVV ≥ 70 % Pred
Diffusion SB Realtime and Diffusion SB Intrabreath classifications are based on DLCO*:

Severe = DLCO < 40% Pred
Moderate = DLCO < 40% to 60% Pred
Mild/Normal = DLCO > 60% Pred and < LLN
Normal = DLCO LLN to ULN Pred
Exceeds = DLCO > ULN Pred
LLN = Lower Limit Normal
ULN = Upper Limit Normal
R Occ classification according to JAEGER (1994) is based on airway resistance R Occ:

Severe = R Occ > 250 % Pred
Moderate = R Occ 250 % to 161 % Pred
Mild/Normal = R Occ ≤ 160 % Pred
P 0.1, MIP / MEP and SNIP classification is based on P 0.1**, MIP / MEP** and SNIP** as follows:
severe = P 0.1 or MIP / MEP or SNIP ≤ -4 Z-Scores or ≥ 4 Z-Scores
moderate severe = P 0.1 or MIP / MEP or SNIP -4 to -3 Z-Scores or 3 to 4 Z-Scores
moderate = P 0.1 or MIP / MEP or SNIP -3 to -2 Z-Scores or 2 to 3 Z-Scores
mild = P 0.1 or MIP / MEP or SNIP -2 to -1.64 Z-Scores or 1.64 to 2 Z-Scores
normal = P 0.1 or MIP / MEP or SNIP - 1.64 to 1.64 Z-Scores
Rhinomanometry classification is based on the logarithmized effective resistance Log10Reff (LReff L/R) of
the 4-phase rhinomanometry according to K. Vogt**** :
Class Color Nasal Resistance log. resistance area
1 green Normal < 0,7
2 green/yellow/ Slightly increased ≥ 0,7 and < 0,9
3 yellow Moderately increased ≥ 0,9 and < 1,1
4 red Severe restriction ≥ 1,1 and < 1,4
5 dark red Very severe restriction ≥ 1,4
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Classification for Bodyplethysmography:

Restriction** classification is based on the Z-Score TLC (Best Total Lung Capacity):
For all patients
Normal = Z-Score TLC > -1.64
Mild = -2 < Z-Score TLC ≤ -1.64
Moderate = -3 < Z-Score TLC ≤ -2
Severe = -4 < Z-Score TLC ≤ -3
Very severe = Z-Score TLC ≤ -4
Obstruction classification is based on the Z-Score Raw (Best Airway Resistance - depending on
the setting Reff, Rtot…) for patients ≤ 18 years and based on the absolute limit values of Raw
for patients > 18 years:
For patients ≤ 18 years**
Normal = Z-Score Raw < 1.64
Mild = 2 > Z-Score Raw ≥ 1.64
Moderate = 3 > Z-Score Raw ≥ 2
Severe = 4 > Z-Score Raw ≥ 3
Very severe = Z-Score Raw ≥ 4
For patients > 18 years***

Normal = Raw < 0.3 kPa/(L/s) = Raw < 3.06 cmH2O/(L/s)
Mild = 0.5 kPa/(L/s) > Raw ≥ 0.3 kPa/(L/s) = 5.10 cmH2O/(L/s) > Raw ≥ 3.06 cmH2O/(L/s)
Moderate = 1 kPa/(L/s) > Raw ≥ 0.5 kPa/(L/s) = 10.20 cmH2O/(L/s) > Raw ≥ 5.10 cmH2O/(L/s)
Severe = Raw ≥ 1 kPa/(L/s) = Raw ≥ 10.20 cmH2O/(L/s)
Interpretation/Comments
The “Interpretations/Comments“ tab enables the user to edit comments or
findings. Prior to entering a comment or findings, select (Technician) or (Physician)
by clicking the corresponding tab. This selection regulates where the comment is
registered. Now text can be entered manually or by using the templates which can
be configured by the user.
If the visit is complete and at least one preliminary report has been saved, “Test
Review” is displayed.
 If “Test Review” is activated, the visit has the status “Test Review”.
Reference:
* Pellegrino R. et. al. Interpretative strategies for lung function tests; Series “ATS/ERS Task Force: Standardisation of lung
function testing“ Eur Respir J 2005; 26:948-968
** M Horstmann et. al. Transfer factor for carbon monoxide; European Respiratory Monograph 31, April 2005; 10: 127-145
*** Criée CP et al. Empfehlungen zur Ganzkörperplethysmographie. Empfehlungen der Atemwegsliga und der DGP. Dustri-
Verlag Dr. Karl Feistle 2009; ISBN 3-87185-394-1.
**** K. Vogt et al. Four-phase rhinomanometry: a multicentric retrospective analysis of 36,563 clinical measurements. Rhinology
2015: Published online.
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Bronchoprovocation Test
Assessment of bronchial hyperreactivity in terms of increased airway
responsiveness to various stimuli plays an important role in the diagnostics of
dyspnea at rest and during physical exercise, chronic cough, asthma and for
medical reports.
Possible stimuli are specific (allergens) and non-specific pharmacological stimuli
(methacholine, histamine, carbachol, hypertonic salt solutions), but also indirect
stimuli such as isocapnic hyperventilation, physical exercise or cold air.
The degree of bronchial reactivity or hyperreactivity is quantified by means of
protocols applying the mentioned stimuli, combined with one or various lung
function tests, which provide a so-called dose-effect curve (response graph).
Use the Sidestream nebulizer.
FEV1
[%]
PD/PC-20 FEV1
FEV1 “PD20”
100
An inhalational bronchoprovocation test
is regarded to be positive if, for example,
90
FEV1 is reduced by 20 % as compared to
the initial value.
80 PD/PC-20
PD20
PD= Provocation Dose
70 PC= Provocation Concentration
60
Baseline Level 1 Level 2 Level 3 [After spasmolysis]

Base (B)
[NaCl] Level (P1) Level (P2) Level (P3) Dilatation (D)
Bronchial response tests are reserved for more in-depth diagnostic issues
regarding the presence of or the therapy effect on bronchial reactivity or
hyperreactivity.
Bronchial provocation is based on the following conditions:

• Suspected asthma/presence of typical asthma symptoms
• Recording of provocation symptoms
• Quality of observation measurements (in particular spirometry) is ensured
• The observation parameters of the base measurement indicate normal lung
function values
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Overdosage has to be avoided, especially with specific

bronchoprovocation tests (allergens). Severe overdosage can result in
anaphylactic shock. Please note that specific provocation tests are part
of an allergy test and should be performed only when an experienced
allergist is present.
Non-specific bronchoprovocation tests also require a great deal of
experience.
Hyperreactive operators should not perform an APS provocation test.

At normal operation, the aerosol filter prevents the ambient air from
being contaminated by the provocation agent.
If the patient leaves the mouthpiece and in case of errors the APS
keeps on nebulizing, the device must be switched off immediately
(operator protection).
Every provocation test with or without response must be followed by

bronchospasmolysis. A bronchospasmolysis must also be performed
and documented if the provocation test was interrupted by the patient
or the patient did not cooperate or if the test had to be interrupted
due to technical reasons (e.g. power blackout, network problems, er-
rors in the APS system).
If the subsequent response test yields normal values, i.e. the measurement
parameters correspond to the values of the reference measurement (% Ref),
the measurement can be terminated.
If the values are still limited, (a) further dilatation step(s) must be performed.
Every provocation protocol must include an observation module which

is enforced and completed by a dilatation step. Please make sure that
you create this sequence when generating your own protocols and that
provocation is always completed by a dilatation step.
Documentation of successfully performed bronchodilatation is part of
every provocation protocol.
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Preventive Measures
Generally, standardized provocation tests with pharmacological substances
and tests in lung function labs require the same preventive measures. The staff
should be familiar with the treatment of airway obstructions and asthmatic
attacks. That means, oxygen and inhalational ß2-sympathicomimetica can be
administered without any delay, if required. A doctor which is experienced in
emergency treatment should also be available at any time.
At no time during the examination must the patient be unattended. The
patient should be informed to interrupt the provocation test immediately
in case of dyspnea . After the test the patient should only leave the lab if
the obstruction - documented by a lung function test - was reversible either
spontaneously or after bronchospasmolysis (FEV1 > 90 % of the reference
value before provocation is desirable). It is recommended to continuously
supervise children‘s gas exchange by transcutaneous pO2 and pCO2
measurement and/or measurement of the O2 saturation (pulse oximetry).
- ATS Guidelines for Methacholine and Exercise Challenge Testing - 1999. Am J Respir Crit Care
Med, 2000; Vol 161, 309 - 329
- ERS Airway Responsiveness
P.J. Sterk et al. Standardized challenge testing with pharmacological, physical and sensitizing
stimuli in adults.
Eur Respir J. 1993, 6, Suppl. 16, 53-63
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Aerosol Provocation System Vyntus APS

In a non-specific provocation test the provocation substance is administered
via inhalation of a pharmacological substance in a known concentration. As an
overdosage must be avoided in any case, exact dosing is very important.
The Vyntus APS is a flow-controlled nebulizer system which produces an exactly
dosed aerosol; this aerosol is then added to the inspiratory air. The Vyntus APS
ensures reliable and exact dosage.
APS Unit
Nebulization occurs solely during inspiration and the biggest portion of the
substance is taken up by the patient.
The in-line aerosol filter with a high absorption capacity prevents further
contamination of the environment.
If the APS unit is used regularly, a compressed air check must be performed
weekly by the operator (see chapter “Compressed air check“).
It must further be ensured that the applied jet nebulizers are new or not used
for more than half a year.
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Preparation
1. Use only clean and disinfected nebulizers.

2. Prepare all nebulizer vessels according to the selected protocol.
Generally, the nebulizer vessels are filled with 2 mL of the
corresponding substance.
P1 P2 P3 P4
Exact dosing is extremely important to avoid any possibility of overdosage.

Therefore prepare the nebulizer vessels carefully with regard to substance and
concentration as the substances may endanger the patient‘s health.
Label the nebulizer vessels!
3. Attach the nebulizer vessel containing the medication for the first provocation
step.
4. Connect compressed air tube to nebulizer vessel.
5. Connect new, disinfected mouthpiece and new aerosol filter.
Aerosol filter
Jet nebulizer
Compressed air tube
Special caution is advised during the filling and the handling of the nebulizer
vessel. Avoid the spillage of liquids!
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Performing Bronchoprovocation
In the following, a bronchoprovocation test will be described.
Settings*:
Protocol: _1-conc_4-step_M-Aid
Observation module: _Spir_FEV1
Observation measurement: Spirometry
Prior to performing a provocation test, a reference measurement must be

performed.
Consequentially, “Start reference measurement“ is displayed on the screen.
* If the provocation test is to be performed with a different protocol or

observation module or the response test in a different measurement program, e.g.
Spirometry, these settings must be made before the provocation test is started.
The setting can be changed under the menu item “Program“.
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Before starting provocation make sure that the correct patient has been loaded.
If the wrong patient is displayed, click <Search> to load a patient already stored
in the SentrySuite database. If the patient has not been saved yet, click <New> to
store a new patient.
Corresponding to the set protocol, the first protocol level B1 is a reference test, i.e.
the measurement is performed without nebulization.
Click <F5> to switch to the reference measurement in the set measurement

program, in our example the “Spirometry“ program.
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Perform a flow-volume measurement.

The measurement is started with <F1> “Start” and ended with <F3> “Stop”.
Screen display after measurement in the “Spirometry“ program:
The results are used to determine whether or not a bronchoprovocation can be

performed with the patient!
If, for example, the actual values for FEV1 are less than 70 % of the predicted
value, this is a contraindication. A provocation test should not be performed!
The predicted value check relates to the parameter limits set in the selected
observation module.
The threshold values are set in the generation program.
The observation parameters of the measurement programs Spirometry,
R Occlusion and Bodyplethysmography may be considered for assessment of a
contraindication.
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Contraindication
The threshold values generated in an observation module aid you in deciding
whether or not a provocation test should be performed in the case of limited
reference values. Example: FEV1 < 70 % of the predicted value
If the reference test yields an FEV1 value of less than 70 % of the predicted
value, a corresponding warning will be displayed for this contraindication after
clicking <Return to Bronchial Challenge>.
Click <Show more> to display the following information:
After clicking <Do not start a provocation sequence. (recommended)>,

the “Bronchial Challenge“ program will be started, however, it will not be
allowed to perform a provocation test due to limited lung function.
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Click <Return to Bronchial Challenge> to start the observation program.
The results of the reference measurement have been entered automatically.

The “FEV1%Base“ parameter will be set to 100 %.
All other measurements will be based on the reference measurement.
In the displayed protocol level B1 (base or reference measurement) is marked by

a “ “ to indicate that it has already been performed. The program automatically
changes to the next level P1 (provocation level 1).
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Administer bronchoprovocation substance.

Corresponding to the selected provocation protocol connect the prepared and
labeled vessel of the first provocation level to the nebulizer. In our example,
you must ensure that the vessel contains the substance “Methacholine“ with a
P1
concentration of “16 mg/mL“ as defined by the protocol. Make sure that the
aerosol filter has been correctly attached to the nebulizer head.
On the screen you are asked to “Start medication“.

Click <F1> to start medication.
The APS compressor is started automatically.
The following message is displayed:
This message is displayed if the medication

selected in the previous provocation level differs
from the currently selected one. Thus, it is
guaranteed that the vessel contains the correct
medication.
Now instruct the patient to approach the mouthpiece and to breathe via the
APS unit. Click <OK> to start nebulization.
In the selected protocol, the

patient takes only one breath
from the prepared vessel in the
first provocation level.
Auxiliary lines limiting the

inspiration range
Dose administration is marked by a red bar. Number of nebulizations performed and yet to be performed
The patient should slowly breathe in and out as evenly as possible. His
breathing curve should be within the shown auxiliary lines (usually less
than 0.5 L/s). Therefore, it is easier for the patient when he can observe his
breathing pattern on screen.
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Please note:
If a nebulizing breath is not performed correctly, i.e. the patient stops
inspiration before the nebulization per breath is terminated, the flow
observation system of the APS recognizes the problem, stops nebulization and
waits for your decision whether nebulization is to be continued or repeated.
Choose “Accept the breath“(recommended) the decreased dose will be

overtaken and nebulization will be continued.
Dose calculation is only based on the currently administered dose.
Choose “Retry the breath“ to ignore the already administered dose and to
repeat the last breath.
If the programmed dose was administered completely, the APS compressor will
switch off automatically.
Nebulization can be aborted at any time during the nebulization phase by clicking
<F3>.
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As soon as the complete dose has been administered, the APS compressor
switches off automatically.
As soon as the nebulization is ended, the following information will be displayed:
The filling bar indicates the remaining exposure time.
After the exposure time has expired, click <F5> to switch to the observation
measurement in the set measurement program, in our example “Spirometry“.
Now perform a flow-volume measurement.

The measurement is started with <F1> “Start” and stopped with <F3> “Stop”.
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Click <Return to Bronchial Challenge> to open the observation program again.

The results of the provocation measurement after the first provocation step P1
have been entered automatically.
In the displayed protocol levels B1 (base or reference measurement) and P1

(provocation level 1) are marked by a “ “ to indicate that they have already been
performed. The program automatically changes to the next level P2.
After every measurement, a limit value check is automatically performed for the
provocation dose (PD) or the provocation concentration (PC).
As soon as the first determination value of an observation parameter

is exceeded, a warning will appear. It is recommended to change to the
dilatation level. In addition, the provocation dose (PD) or provocation
concentration (PC) determined for the observation value will be
displayed.
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labeled vessel of the second provocation level P2 to the nebulizer.
If concentration and substance do not change, the vessel of the previous
P2 provocation level can be continued to be used.
At this point we relinquish the description of the provocation step P2 with the
corresponding control measurement and we proceed with the provocation
step P3.

P3 labeled vessel of the third provocation level P3 to the nebulizer.
If concentration and substance do not change, the vessel of the previous
provocation level can be continued to be used.
On the screen you are asked to “Start medication“.
Click <F1> to perform nebulization as described previously.

Click <Return to Bronchial Challenge>.
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In our example, the response measurement after the third provocation

level yielded a significant limitation of the lung function, i.e.
FEV1 is reduced by more than 20 % as compared to the reference
measurement. As a consequence, a message appears indicating that
the determination value of the observation parameter (FEV1) has been
exceeded. The provocation dose/provocation concentration of this
observation parameter will additionally be indicated.
Message:
It is strongly required to start dilatation.
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The results of the provocation measurement after the third provocation step P3
have been entered automatically.
In the displayed protocol levels B1 (base or reference measurement), P1, P2 and

P3 are marked by a “ “ to indicate that they have already been performed. Level
P4 is marked by an “X“ to indicate that it has not been performed. The program
automatically changes to the dilatation level.
In our example the determination value of the observation parameter

has been exceeded.
The parameter FEV1 has decreased by almost 26 % as compared to the value
measured in the base/reference measurement.
On the screen the following message is displayed:
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Result:
An inhalational bronchial provocation test is to be regarded as positive if FEV1 is
reduced by 20 % as compared to the initial value.
Comparison of the test results with reference values after bronchoprovocation.
Reference Test After bronchoprovocation

FEV1 = 3.68 L = 100 % FEV1 = 2.75 L = 74.6 %
In our example, FEV1 is reduced by 25.4 % after bronchoprovocation as compared

with the reference test.
The provocation test was positive!
If the calculation of a threshold dose (PD/PC) for each of the selected parameters
(in our example for FEV1) is generated in the observation module, these values will
be displayed in the response table.
If the axis of the response graph represents “Amount“ or

“Cumulated amount“, “PDs“ will be calculated and saved. If the axis
represents “Concentration“, “PCs“ will be calculated and saved (see
generation program).
PD = Provocation dose
PC = Provocation concentration
For our example the determined threshold dose (PD) at PD/PC20

for FEV1 is 0.089 mg.
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Please note:
The limit values as well as the threshold values can be generated freely and are
part of the observation module.
After every bronchoprovocation test with or without response a

bronchodilatation has to be performed.
Dilatation
Click <F1> to activate the next level, in our example level “D“ = Dilatation.
On the screen you are asked to administer the dose defined in the protocol:
For our example, 2 puffs of Sultanol which are not administered via the APS but
through a spray.
Administer the substance and click <OK> to confirm.
After an exposure time of 5 minutes, the response measurement can be started.

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Click <Return to Bronchial Challenge>.
The results of the dilatation measurement are displayed on the screen:
If the dilatation test yields normal values (parameter FEV1%Base=>90%),

the test can be ended.
If the values are still limited, one or more additional dilatation steps
have to be performed.
Click “Classification“ to display a classification bar corresponding to the settings

in this measurement program.
See chapter “Program Settings“.
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Provocation protocol with more than one measurement

application
If observation parameters from different measurement applications are assembled
in an observation module, the following procedure has to be applied to guarantee
the complete recording of the dose-effect relationship (response graph).
Our example is based on the observation module “_IOS“ with the oscillometric
observation parameters R5Hz and Fres from the measurement application impulse
oscillometry as well as the observation parameter FEV1 from the measurement
application forced spirometry.
If the previously measured lung function values are to be transferred as base
measurement when the bronchial challenge program is selected, it is required that
all measurements are already available. In our example IOS and spirometry.
If the base measurements are performed in the bronchial challenge program,

make also sure that the observation parameters are determined completely.
Only those measurement applications are switched active and are selectable to
which observation parameters have been assigned.
In our example <F5> spirometry and <F8> impulse oscillometry are active. As it is
recommended to perform examinations at rest prior to forced maneuvers, impulse
oscillometry is examined first which is started with <F8>.
After returning from impulse oscillometry into the bronchial challenge program,
the desired oscillometric observation parameters are already registered in the
parameter table, however, the values of the measurement application forced
spirometry are still missing. Then start and perform the missing measurement
application, in our example spirometry by clicking <F5>.
If the setting “Allow to skip observation measurements” is activated then
within the provocation steps the provocation program will query if the second
observation measurement should be proceeded or skipped.
If the observation parameters have been determined completely, the subsequent
provocation step suggested by the system is permitted to remain active.
Nebulization is then triggered via <F1>.
The observation parameters of all measurement applications have to be

recorded for the dilatation step as well.
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Compressed Air Check

Compressed Air Check allows to check whether the compressed air flow is within
a defined range.
A valid volume calibration of the APS unit is a precondition.
1. Start the “Bronchial Challenge“ program.
2. Select <Compressed air check> in the command menu “Checks“ .
The following appears:
rubber plug
3. Connect (empty) nebulizer vessel and close the opening at the patient‘s
side with a rubber plug.
4. Start the check by clicking <OK>.
Screen display during compressed air check:
Screen display after compressed air check:
5. Click <Yes> to save the compressed air check.
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Report
After a measurement, the results can be reported by being displayed on the
screen, outputted to a printer, stored at any location as PDF, TIF, or JPG, or
allocated to the corresponding visit in an individually definable report*1.
Click on one of the tabs available in every measurement program.
The tabs indicate the output type and the report names assigned to the individual
tabs.
The following output types are available:
A Preview PDF of the report is displayed on screen and can then be printed out
and/or saved in the database to the corresponding visit with the status Preliminary,
Final or Corrected.
A Full View of the Report is displayed as PDF on screen and further offers the
following options:
- select a different visit
- save report with the status Preliminary, Final or Corrected
- print out report
- save report as a PDF file at any location
- save report as a TIF, JPEG or RTF file at any location (optional)
- enter a comment on the measurement
- send report to the Hospital Information System
The report is directly printed out.
The report is saved to the database to the corresponding visit with the status
Preliminary, Final or Corrected.
The following output types are preset:
- Quick View
- Print
- Save
Click <...> to select different reports. It is further possible to freely define the
3 tabs.
Reports are defined in the Report Designer program.

*1
Please refer to the online manual for a detailed program description.
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Possible Sources of Error and Remedies

Application
Calibration is not repeatable! - AirLife filter from Vyntus APS is perhaps dirty
- pump volume does not correspond to the set volume
- enter XX mL for the pump volume
Volume drift during occlusion too large. - let the patient leave the mouthpiece - initiate zero adjust-
ment - repeat measurement
- test the system for leaks
Zero adjustment failed. The patient must not yet approach the mouthpiece.
Repeat zero adjustment.
No measurement possible. Enter patient data.
No Cal. gas connected or pressure too low. Open the gas cylinder or replace the empty gas cylinder.
Calibration gas not stable.
Incorrect calibration value(s), calibration stop- Please check the settings and the measurement device and
ped. repeat the calibration.
Compare the specifications on the cylinder (certificate of
analysis) with the specifications in the setting of the calibration
program and make the respective corrections.
Clean or replace the sample line.
Replace the sample line with a new or a dry sample line.
Data Exchange with JAEGER JLAB/SensorMedics Vmax

The SentrySuite Connectivity Software allows to exchange patient and test data
with
- JAEGER JLAB
- SensorMedics Vmax
- Medical Graphics
- nSpire
- SPCS (Spirometry PC Software from Micro Medical)
In particular, data exchange with JAEGER JLAB and SensorMedics Vmax offers the
following comfortable solutions:
- Import of patient data from SentrySuite to JLAB/Vmax
- Real-time transfer of JLAB/Vmax patient and test data to SentrySuite
- Batch transfer of JLAB/Vmax patient and test data to SentrySuite
Predicted modules of the source system are not transferred to SentrySuite.

Only the name of the predicted module is transferred. Thus, it is necessary
either to create a new predicted module in SentrySuite with the same name as
the source predicted module prior to the transfer or to assign the transferred
visits manually to a predicted module existing in SentrySuite.
As the setup for the data exchange with Vyaire JLab and Vmax systems via the
connectivity software typically strongly depends on the local laboratory and IT
environment please contact Vyaire tech support for further advice.
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Online Manual
Before dispatching your Vyntus system, we have already installed an exact Online
Manual on the hard disk of the delivered computer. This manual can be loaded
from the start screen or any SentrySuite application program.
To launch the Online Manual, click “?“ in the menu bar, then User manual and
then Table of contents.
The “Acrobat Reader“ will be loaded automatically, displaying the “Online
Manual“ on the screen.
Click the corresponding entry The Online Manuel also includes

for loading the Online Manual. the latest version of the
Disposables and Accessories
Catalog (non-US only).
Hygiene
The instructions on hygiene are described in the separate manual “Instructions
for Cleaning and Disinfection of Reusable Parts”.
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General Safety Precautions
This Instructions for Use is part of the instrument, and should always be kept
on hand.
The instruction manual describes the present state of the device/system including
software and accessories with regard to the fundamental requirements of the
MDD 93/42/EC.
Exact adherence to the instructions issued is a prerequisite for proper and intended
functioning of Vyaire instruments.
Deviation from Intended Use

Any non-observance of the procedures (such as preparation for the measurement
and methods, disinfection procedures, use of accessories and replacement parts
etc.) described in the Instructions for Use results in a deviation from intended use.
It should also be noted that the use of non-authorized parts may impair the results
of a measurement.
In case of a deviation from intended use the user/operator has to supply proof
of meeting all corresponding fundamental requirements. This is possible by
performing a corresponding conformity assessment procedure within in-house
manufacturer (cf. § 12, paragraph 1 last sentence of MPG
(= Medizinproduktegesetz/Medical Devices Act).
The user/operator is, however, responsible for performing the conformity
assessment correctly and is also completely liable for defective products - i.e. the
user/operator is liable for but not limited to his/her modification of the medical
product.
Disposables and accessories with a limited service life have to be disposed of after
expiration.
Vyaire only guarantees for the safety, reliability and functionality of the instrument
if
- installation, extension, modifications, and repairs are exclusively carried out by
specialists authorized for these tasks by Vyaire (inappropriate intervention can
cause danger to life!)
- the room in which the equipment is operated complies with the installation
instruction according to DIN VDE 0100 Part 710 (IEC 60364-7-710).
- the unit can be plugged into a medical grade socket with a protective
conductor system.
- the ambient conditions at the place of installation are suitable for the unit.
- the unit is used according to the training manual and instructions for use.
Unpack your medical device. Please check if the unit is damaged. If so, do not use
it and return it to Vyaire for a replacement.
Electrical Safety
As far as Protection Category I equipment/systems are concerned, their
touchable and maybe voltage-carrying metal parts are electrically conductively
connected to each other and connected to the grounding cable of the mains
power supply. A circuit breaker will be tripped should the insulation fail.
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To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Patient Safety according to IEC 60601-1

With your Vyaire unit the patient is as safely insulated from the mains voltage as
required in the safety regulations on leakage current according to IEC 60601-1.
Nevertheless, a patient environment must be defined. That means the patient
has to keep a distance of at least 1.5 meters from all open interfaces, connectors
and information processing devices (e.g. PC, monitor) to avoid any contact with
electrical voltage. The operator must not touch any conductive parts and the
patient at the same time.
Valid for all Vyaire Devices
The installation of the ME (medical electrical) system must be performed by
authorized specialists only. All system components, which connected to wall
sockets must be easily accessible, allows to disconnect easily the system
during an incident.
Isolating from supply mains: For safe disconnection from the mains, the
The connection of further power-operated units to your Vyaire unit causes all
the leakage currents to add-up. Since this may reduce the safety of the patient,
the entire leakage current has to be re-assigned with every expansion of further
power-operated units. The connection of further units may only be carried out on
consultation with the Vyaire Global Customer Support.
If the medical system is connected to an IT network, an isolation barrier with two
Means Of Patient Protection (MOPP according to section 16 of the 3rd edition of
IEC 60601-1) must be used.
Only optional devices or external devices approved by Vyaire are allowed to be
connected to the interfaces.
Additional equipment connected to medical electrical equipment must comply
with the respective EN (IEC) or ISO standards (e.g. IEC 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements for
medical electrical systems ((section 16 of the 3rd ed. of IEC 60601-1). Anybody
connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that
local laws take priority over the above mentioned requirements. If in doubt,
consult your local representative or the Vyaire Global Customer Support.
If a separate power supply is used for the external ME devices or other additional
Vyaire Medical devices in a ME system (a connection of ME devices and Vyntus
devices), an additional potential equalization conductor has to be installed to
the potential equalization between the single ME devices or to the potential
equalization of the building wiring installation in order to prevent differences in
the electrical potential.
Use of Multi-Plug Sockets

Due to increased safety requirements medical devices/systems may only be
connected to multi-plug sockets if all requirements of section 16 and amendment I
or the 3rd edition of IEC 60601-1 are met.
- Additional mobile multi-plug sockets must not be connected to mains sockets
of medical devices/systems.
- Mobile multi-plug sockets of medical devices/systems must not be placed on
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the floor.
- Equipment (for example vacuum cleaner, radio...) and devices which are not
part of the medical device/system must not be connected to the multi-plug
socket.
- Additional multi-plug sockets or extension cables must not be connected to the
ME system.
EMC Notes
This Vyaire device meets the regulations according to IEC 60601-1-2 regarding
the interference radiated and received. The device should not be installed in the
vicinity of high-frequency devices, X-ray equipment, motors or transformers with
high installed power rating since electric or magnetic interference fields may falsify
the result of measurements or make taking measurements impossible. Due to this,
the vicinity of power lines is to be avoided as well.
Changes or modifications to the Vyntus devices may result in increased emissions
or decreased immunity of the Vyntus devices in relation to EMC performance.
WARNING: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Vyntus devices, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result.
WARNING: Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
WARNING: This equipment has been tested for radiated RF immunity only at
selected frequencies, and use nearby of emitters at other frequencies could result
in improper operation.
Keep a distance of about 2 meters from possible error sources when using the
device.
WARNING: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
The Vyntus Devices have essential performance (see “Technical Data”). This can
be verified during the verification and calibration process. In the unlikely event of a
Fast Transient / ESD event occurring, the device should be reset and located away
from the source of interference.
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EMC testing was performed according to follwing standards
Emission tests Compliance

RF emissions CISPR 11 (Radiated Emission) Class B, Group 1
Harmonic emissions IEC 61000-3-2, Class A
Voltage fluctuations/flicker emissions Passed
IEC 61000-3-3
Immunity tests Compliance
Electrostatic discharge (ESD) IEC 61000-4-2 Contact: ± 8 kV; Air: ±2 kV, ± 4 kV, ± 8 kV, ± 15
kV
Electrical fast transient/ burst IEC 61000-4-4 ± 2 kV; 100 kHz repetition frequency
Surge IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2 kV
Voltage dips, short interruptions and voltage 0 % UT; 0,5 cycle
variations on power supply input lines At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
IEC 61000-4-11
0 % UT; 1 cycle and 70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle

Power frequency (50/60 Hz) magnetic field 30 A/m; 50 & 60 Hz
IEC 61000-4-8
Conducted RF IEC 61000-4-6 3 V: 0,15 MHz – 80 MHz
6 V in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
Radiated RF IEC 61000-4-3 3 V/m: 80 MHz to 2.7 GHz
IMMUNITY to proximity fields from RF wireless 28 V/m
communications equipment IEC 61000-4-3 450 MHz, 50% PM at 18 Hz
810 MHz, 50% PM at 18 Hz
870 MHz, 50% PM at 18 Hz
930 MHz, 50% PM at 18 Hz
1720 MHz, 50% PM at 217 Hz
1845 MHz, 50% PM at 217 Hz
1970 MHz, 50% PM at 217 Hz
2450 MHz, 50% PM at 217 Hz
27 V/m
385 MHz, 50% PM at 18 Hz
9 V/m
710 MHz, 50% PM at 217 Hz
745 MHz, 50% PM at 217 Hz
780 MHz, 50% PM at 217 Hz
5240 MHz, 50% PM at 217 Hz
5500 MHz, 50% PM at 217 Hz
5785 MHz, 50% PM at 217 Hz
Prolonged voltage interruptions do not lead to long-term impairment of the mea-

suring system and patient or user hazards.
List of EMC important cables. Do not exchange by other types.
Part Number Description

V-918465 USB2.0 Cable Vyntus BODY to PC
992441 Microphone for sound card
918100 Power line EU to Vyntus BODY
S760707 Power line US to Vyntus BODY
918256 Potential Equalization of Vyntus BODY
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Do not use this device in an MRI environment.
Ambient Conditions
The medical device must not be operated in rooms or in the presence of
flammable anesthetic mixture with air or flammable anesthetic mixture with
oxygen or nitrous oxide. The device is not to be used in Oxygen enriched
environments (>25 Vol% O2).If gases and pharmacological substances (aerosol)
are used, a good ventilation is necessary.
The medical device must be operated in rooms where only non-conductive
pollution occurs; however, occasional temporary conductivity due to condensation
is to be expected. The medical device is designed for operation in medically used
rooms.
The medical device has to be effectively protected against moisture. Ventilation
slots must be kept free of obstructions in order to enable air circulation.
Putting the Unit into Operation

Always consult the nameplate and the adjustments of the voltage selector switch,
if available, on the device/system for compliance of the unit‘s own data with those
of the local power supply system (mains voltage and mains frequency) before
actually connecting the unit. Connect only if all data comply!
Inspect the mains connection cable, plug, and receptacle for visible damages
prior to establishing the connection. Damaged cables or plugs must be replaced
immediately.
For devices that are not powered via the Vyntus CART, turning On/Off of the CART
is ineffective.
Preparing and assembling for measurement of the device must only be done in
compliance with this Instructions for Use.
After the first setup or if the setup has been changed (e.g. exchanging of USS
module), a function test (e.g. verification/calibration) has to be performed.
Medical Supervision
A qualified physician has to reassess all Vyntus /SentrySuite measurements. An
interpretation by Vyntus/SentrySuite is only significant by confirmation of other
clinical findings.
The operator is responsible for the change of predicted modules, authors or the
entry of new predicted value formulas.
Merging of Patient Databases

Before merging different databases in a mixed network, we would like to advise
you of the following facts:
- If databases (DB) are merged from different sources (offline measurements,
heterogeneous networks), it may occur that in the two different databases the
same patient IDs were assigned to persons who are not identical in reality.
- Thus it is necessary to check identical patient IDs stored in the two databases
and correct them manually before merging the data.
- Please note that you, as the operator of the medical product, are responsible
for ensuring that no incorrect person-related diagnoses are made or treatments
are performed due to identical patient IDs.
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Contraindications
The patient‘s case history has to be matched with the contraindications possibly
existing for the individual measurement methods in order to minimize the risk to
the patient.
Cleaning and Hygiene

All reusable parts which are in the patient breathing path, must upon initial receipt
be purified by stirring in deionised water for 5 minutes before the first application
of a test subject.
(Except when the operator uses other guidelines on his own responsibility!)
Prior to taking measurements on a patient, his/her medical history is to be
checked in order to avoid a contamination of the device and a resulting cross
contamination of the next patient.
While performing a calibration, all applied parts that the breath travels through
(such as the measuring sensor, etc.) must be new or disinfected to prevent cross-
contamination between the calibration syringe and the parts. This will prevent
contamination of the pump and allow for its reuse.
When using bacterial filters, these filters must be used for the calibration routine.
Always be sure to pull the plug before cleaning or disinfecting the devices/systems.
In reference to humidity and water that may get inside the units, the Vyaire
devices correspond to the safety degree IP 20. This means, the device can be
cleaned with a damp (but not soaking) cloth which does not produce lint. More
detailed information can be found under “Hygiene“.
Chemicals required for operation or care of the unit must always be stored, pre-
pared, and made available in specially marked vessels to prevent any accidental
use.
Maintenance
Information regarding regularly exchanged parts is found in the Instructions for
Cleaning and Disinfection. Do not service or maintain any part of the medical
device while it is in use with a patient. Use only Vyaire approved accessories and
spare parts for this medical device. Service and Maintenance of the medical device
may not be performed during intended use. If applied parts (e.g. USS module)
have been exposed to extreme mechanical stress, a function test (e.g. volume
verification) has to be performed. If function is lost, the defective part is to be
replaced. Damaged parts, e.g. frayed plugs, receptacles, pressure regulators, a
damaged USS module, and defective cables should be replaced immediately by an
authorized specialist or engineers of the Vyaire Global Customer Support or,
if necessary, be put out of service after notifying the Global Customer Support. If
it is opened without authorization the guarantee entitlement expires. The Vyaire
Global Customer Support is always at your disposal with help and assistance
in case of problems. The system needs to be switched off and disconnected from
the power supply network. Make sure that the system can not be switched on
accidentally.
All connections and protective measures that have been disconnected or changed
during the maintenance phase must be rebuild to the condition that the safety
of the medical device / system is guaranteed on reactivation. (see installation
instructions)
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Immediate maintenance by specialized personnel is necessary if e.g.

Maintenance and inspection Frequency of maintenance and Inspection Maintenance

inspection / type of inspection executed by executed by
power cable, power plug, power daily / visual operator /
socket and power input are authorized
defective organization
the device has been exposed to an immediately after the incident / authorized
extreme mechanical impact (e.g. visual, organization
the cable gets damaged because retesting according to IEC 62353
a heavy object runs over it or it is
pulled in an improper way)
liquid has gotten into the device immediately after the incident / authorized
visual, organization
retesting according to IEC 62353
power cable, plug connector and daily / visual operator /
tube connections are defective authorized Vyaire Global
organization Customer
Support /
the gas spring support arm drops immediately after the incident / operator / authorized
into the lowermost position by visual authorized organization
itself daily / visual organization
rubber connections have cracks every year / visual, functional operator /
authorized
organization
modules show embrittlements or every year / visual, functional authorized
cracks organization
wheels and brakes work correctly every year operator /
authorized
organization
shelfs, drawers and supporting every year operator /
parts authorized
organization
Version 01.00 • 2021-02-01 Page 141/170

For all medical devices by Vyaire the primary reference values will be detected,
documented and attached prior to dispatch according to IEC 60601-1. Only units
which have been maintained orderly and within regular periods of time are safe.
Maintenance and inspection can be carried out by the Vyaire Global Customer
Support, also as part of a maintenance contract.
Technical documentation, schematic circuit diagrams, stock lists, and descriptions
are available on request at the Vyaire Global Customer Support. An authorized
organization must receive training and a certification by the Vyaire Global
Customer Support.
All serious incidents which are associated with the product should be reported to
the manufacturer and the responsible authority where the user and/or the patient
is located.
Keep disposables, accessories, packing material, cleaning and disinfection

substances out of the reach of children.
Death due to suffocation if packing material is swallowed or used to cover
the head.
Store packing material out of reach of children or mentally disabled persons and
dispose of it according to local directives!
Recurrent Test
For the secure operation of medical electrical equipment IEC 62353 (Medical
electrical equipment - Recurrent test and test after repair of medical electrical
equipment) is valid in principle. IEC 62353 defines that a recurrent test has to
be performed at regular intervals and after a repair of the medical electrical
equipment. Put the device out of service and notify the Global Customer Support
if aberrations beyond the limit values occur.
Vyaire specifies an interval of 3 years.
The calibration syringe itself has to be re-calibrated at regular intervals. For further
information see enclosed certificate.
In case of aberrations contact Vyaire Global Customer Support for assistance.
Perform system verification according section “Calibration / Verification
Frequency”.
Recycling
Observe the WEEE directive and follow all Federal, State and Local regulations or
contact Vyaire Global Customer Support for assistance when disposing the medical
device, its accessories or batteries.
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Additional Safety Precautions for Vyntus CART 3.b
Patient environment:
A patient environment of 1.5 meters to the Vyntus CART 3.b has to be kept.
That means the patient has to keep a distance of at least 1.5 meters from all
open interfaces, connectors and the Vyntus CART 3.b to avoid any contact with
electrical voltage.
Transport conditions for the CART 3.b

- Disconnect all electric and pneumatic connections to other products or
networks.
- The ultimate load of drawer, shelves, keyboard rack etc. must be observed (refer
to the imprint!).
- Move the Vyntus CART slowly and carefully on uneven

ground to avoid tilting.
- Take care on storage and fixation during transport of the
Vyntus CART to prevent damage.
Top shelf - Move the Vyntus CART slowly and carefully on uneven
ground to avoid tilting.
Keyboard
- When restarting the device the original safety standard
drawer has to be restored (PE, network isolator etc.)
- Make sure that no people are injured or no objects are
damaged while moving the CART.
- The keyboard drawer should be closed and locked in
Shelf with drawer
place.
- Make sure that the mouse does not fall off the rack.
- Make sure that the sliding shelf is drawn in.
- The Vyntus CART should only be moved at a maximum
walking speed of 6 km/h (3,7 mph).
Vyntus CART 3.b
Handling of the Vyntus CART 3.b
Brakes:
- Set the four brakes during operation.
- Release the four brakes for the transport.
Positioning of the monitors:

To position the monitors vertically undo the wing screw and tighten it again.
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Knurled screws and Stop unit
Handling of the keyboard:

- Pull the drawer out to use it.
- Reset the keyboard rack to the transport position while it is not in use.
- To prevent the keyboard from sliding backwards, bring the knurled screws and
the stop unit into the right position and tighten.
Keyboard
How to open the CART 3.b:

- If required, an authorized specialist may open the CART with an adequate tool
(e.g. screwdriver, coin) to adjust the system.
- The cover of the CART has to be closed during operation.
- All protective conductor connections have to be re-established when the
covers are closed again.
Handling of the ambient unit

Do not expose the ambient unit to negative ambient influences (sun, draft, etc.) to
obtain correct measurement data.
Handling of the power unit mount of the Vyntus APS option:

The mount for the Vyntus APS power supply is mounted underneath
the drawer and may only be used for these power supply.
Ultimate load definitions of the Vyntus CART 3.b:

Top shelf: max. 200 N / 20 kg / 44 LBS
Keyboard rack: max. 30 N / 3 kg / 6.6 LBS
Shelf with drawer: max. 150 N / 15 kg / 33 LBS
Sliding shelf: max. 30 N / 3 kg / 6.6 LBS
Power supply
Monitor: max. 85 N / 8.5 kg / 18.7 LBS
PC holder (micro): max. 15 N / 1.5 kg / 3.3 LBS
Power supply mount: max. 10 N / 1.0 kg / 2.2 LBS
Attention: The max. load is 75 kg (165 LBS).

The total weight is 125 kg (276 LBS).
Isolating from supply mains

For safe disconnection from the mains, the power supply cord must be pulled.
Page 144/170 Version 01.00 • 2021-02-01

Patient environment for the Vyntus APS:

If the Vyntus APS on the Vyntus CART 3.b is used, a patient environment of
1.5 meters to the Extended Basic Module for Vyntus APS has to be kept. That
means that the patient has to keep a distance of at least 1.5 meters from all open
interfaces, connectors and the Extended Basic Module to avoid any contact with
electrical voltage.
Additional Safety Precautions for Vyntus CART 3.0N / 3.1N
Patient environment:
If a Vyntus CART 3.0N / 3.1N is used in combination with a Vyntus BODY (without
a Vyntus APS) an additional potential equalization conductor has to be installed
to the potential equalization between the single ME devices or to the potential
equalization of the building wiring installation in order to prevent differences in
the electrical potential.
In this combination a patient environment of 1.5 meters to the Vyntus CART 3.0N
/ 3.1N is not necessary, nevertheless, the Vyntus BODY is powered by a separate
wall socket.
Transport conditions for the Vyntus CART 3.0N / 3.1N

- Disconnect all electric and pneumatic connections to other products or network
- Take care on storage and fixation during transport of the Vyntus CART to
prevent damage.
- The ultimate load of drawer, shelves, keyboard rack etc. must be observed (refer
to the imprint!). Move the Vyntus CART slowly and carefully on uneven ground
to avoid tilting.
- The ECG telescope arm needs to be retracted completely and placed centrally
behind the Vyntus CART.
- When restarting the device the original safety standard has to be restored (PE,
network isolator etc.)
- Make sure that no people are injured or no objects are damaged while moving
the Vyntus CART.
- The keyboard drawer should be closed and locked in place.
- Make sure that the mouse does not fall off the rack.
- Gas cylinders must be transported according to the specifications given in the
chapter “Safe Gas Handling“.
- Make sure that the sliding shelf is drawn in.
- Push the ECG tripod (option) in as much as possible.
- The Vyntus CART should only be moved at a maximum walking speed of 6 km/h
(3,7 mph).
Version 01.00 • 2021-02-01 Page 145/170

Handling of the Vyntus CART 3.0N / 3.1N
Brakes:
- Set the four brakes during operation.
- Release the four brakes for the transport.
Positioning of the monitors:

To position the monitors vertically undo the wing screw and tighten it again.
Knurled screws and Stop unit Handling of the keyboard:

- Pull the drawer out to use it.
- Reset the keyboard rack to the transport position while it is not in use.
- To prevent the keyboard from sliding backwards, bring the knurled screws and
the stop unit into the right position and tighten.
Keyboard
Handling of the ECG telescope arm:

- Two clamping elements lock the lengthwise adjustment (transport: adjust to
shortest length).
- The height of the ECG telescope arm can be adjusted by means of the clamp-
ing device (transport position should be horizontal).
- Make sure that the ECG telescope arm is directly above the Vyntus CART.
Clamping elements
Clamping device
Page 146/170 Version 01.00 • 2021-02-01

Retainer for two Gas Cylinders:

- The retainer is designed for a maximum of 2 gas cylinders.
- For additional specifications, please refer to the chapter “Safe Gas Handling“.
How to open the CART:

- If required, an authorized specialist may open the CART with an adequate tool
(e.g. screwdriver, coin) to adjust the system.
- The cover of the CART has to be closed during operation.
- All protective conductor connections have to be re-established when the
covers are closed again.
How to adjust the workspace height of Vyntus CART 3.1N:

- Open the locking screw with care (working space can move up/down).
- Adjust height of working space as needed.
- Move with care and observe straining of wires or tubes or equipment on the
lower shelf.
- Lock the position with the locking screw
Ultimate load definitions of the Vyntus CART 3.0N / 3.1N:

Top/Bottom shelf: max. 200 N / 20 kg / 44 LBS
Keyboard rack: max. 30 N / 3 kg / 6.6 LBS
PC holder (micro): max. 15 N / 1.5 kg / 3.3 LBS
Dual gas bottle (option): max. 2 x 65 N / 6.5 kg / 14.3 LBS
Monitor: max. 85 N / 8.5 kg / 18.7 LBS
Height adjustable workspace
CART 3.1N max.100-160 N / 10-16 kg / 22-35.3 LBS
Attention: The maximum load is 800 N / 80 kg / 176 LBS.

The total maximum weight is 1400 N / 140 kg / 308 LBS.
Version 01.00 • 2021-02-01 Page 147/170

Additional Safety Precautions for Vyntus BODY
In order to prevent disturbances caused by ambient influences, do not position the

box in direct sunlight, keep doors and windows closed and avoid tremors in the
measurement laboratory during a measurement.
The swivel-chair in the box can be loaded up to a maximum of 150 kg

(330 LBS).
Use the height adjustment activator of the swivel chair to move into the correct
seating position of the patient.
Height adjustment activator
Press the height adjustment activator

upwards and move the seat either up
or down until the required position is
reached.
The patient must be supervised at all times during the measurement procedure
and must never be unattended.
Open the door of the box immediately after the bodyplethysmography

measurement in order to avoid a lack of oxygen inside the box.
Close and open the door of the box slowly and carefully in order to avoid great
pressure changes in the box.
Check the sealing material of the box for bumps and scratches every day prior to a
measurement; check the rubber joints.
Patients suffering from claustrophobia (take anamnesis into account) should be
informed in time that the door of the box can be opened from inside at any time
by using the door opener.
Door opener
Page 148/170 Version 01.00 • 2021-02-01

The bench in the box can be loaded up to a maximum of 250 kg (551 LBS).
Vyntus BODY with bench
Version 01.00 • 2021-02-01 Page 149/170

Vyntus BODY interfaces
APS pressure
connection APS Pressure: 1,4 bar
SB (RT) IN
SB (RT) IN supply CO: 3000 ppm
gas connection CH4: 3000 ppm

(C2H2: 3000 ppm)
Rest: synt. Air
Pressure: 7 bar
Vyntus BODY gas port
Vyntus BODY power port

Vyntus BODY control port
I/ O
POWER Power connection
APS HEAD
connection
USB PC
connection
Potential equalization
connection
Cal gas port
Gas sample port
Page 150/170 Version 01.00 • 2021-02-01

Patient environment for Patient with or without wheel chair in front of

Vyntus BODY:
When measuring patients with or without wheel chair in front of the Vyntus
BODY, a patient environment of 1.5 meters to the Vyntus CART 3.b or desktop
devices has to be kept. That means that the patient has to keep a distance of at
least 1.5 meters from all open interfaces, connectors and information processing
devices (e.g. PC, monitor) to avoid any contact with electrical voltage. The operator
must not touch any conductive parts and the patient at the same time.
If a Vyntus CART 3.0N / 3.1N is used in combination with a Vyntus BODY (without
a Vyntus APS) a patient environment of 1.5 meters to the Vyntus CART 3.0N /
3.1N is not necessary.
LED status table for Vyntus BODY

LED Multicolor Code system status possible action
Type of light Color status -

- Bootloader hardware initialization none
- Bootloader selftest
white
- Waiting for application update
- Testing CRC of application
Waiting for application update (in contact the service department
green, orange
case of CRC error)
Updating application Wait. System restarts
green
automatically after the updates.
orange Bootloader error contact the service department
- Application hardware initialization none
blue
- Application selftests
multicolor Warm up none
blue system ready start measurement

blue, green for measurement active perform measurement
CPET
blue, magenta for
PFT
Application error restart the system or contact the
orange, blue
service department
- Host inactive switch on the PC, exit standby
blue mode, plug in the USB cable
- Standby
Green LED = Measuring / data acquisition active = Permanent ON

Orange LED = Test / error codes = Blinking
Blue LED = Operating mode / sleep mode = Fading
Handling the drying tube for gas analysis

Among other things, the drying tube is used to dry the exhaled humid gas on its
way to the analyser.
This drying effect will diminish over time due to material limits.
The drying tube should be replaced
- after 6 months of use
- if the drying tube shows cracks or is physically damaged
Version 01.00 • 2021-02-01 Page 151/170

Exchange of the drying tube:

Please make sure that the drying tube for gas analysis runs within the duct of
the Vyntus BODY clamp mount after being exchanged.
Handling instructions for tempered safety glass
The door and all the panes on the Vyntus BODY are made of tempered glass.
Thermal treatment makes tempered glass especially stable. If it breaks, it crumbles
into small granular chunks to effectively minimize injuries from cuts and impact.
Please note:
- Keep the pivot range of the door completely free of objects it can poten-
tially hit
- Keep the door from striking any hard objects, e.g.: chair legs and bases,
office chair rollers, stones, etc.
- Use only soft, lint-free cloths for cleaning – do not use anything that
scratches, e.g., scrapers, scrubbing sponges, and the like.
Additional Safety Precautions for Vyntus APS

Power supply of the Vyntus APS:
When the Vyntus APS is part of the system the installation has to be done accord-
ing the installation instruction manual by an authorized specialist.
- The Vyntus APS may only be connected to the Magic Power power supply unit.
It may not be powered by other supply units.
- The Vyntus devices may only be connected to IEC 60950 components by means
of a USB cable with galvanic isolation.
o This will protect the Vyaire medical device from residual currents of
additional third-party products which have to communicate with IEC 60950
components (PC, etc.).
o All IEC 60950 components must be placed outside the patient environment
o The Exended Basic Module for Vyntus APS must be placed outside the patient
environment (for more information, see section „Patient environment for
Vyntus APS“).
o Potential equalization is not necessary.
Interfaces of the Vyntus APS:

- Only optional devices or external devices approved by Vyaire are allowed to be
connected to the optional interfaces of the Vyntus devices
- Only connect applied parts approved by Vyaire to the interfaces.
- Only applied parts which have 2 MOPP with regard to the operating voltage of
250VAC are allowed to be connected.
Patient environment for the Vyntus APS:

A patient environment of 1.5 meters to the Vyntus Extended Basic Module for
Vyntus APS has to be kept. That means the patient has to keep a distance of at
least 1.5 meters from all open interfaces, connectors and the Vyntus Extended
Basic Module to avoid any contact with electrical voltage. This is also necessary if a
Vyntus CART 3.0N / 3.1N is used.
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Front side: LED status Handling of the “Extended Basic Module“ for Vyntus APS
- status LEDs (description see “LED status table“)
- Disconnect the system while manipulating the interfaces (disconnection or
connection).
- Please note the color coding and coding during the handling of the interfaces.
connection for
future options
Rear side:
connection
pressure hose connection APS head
APS head
USB-PC
connection
connection for future options

connection shutter (shutter control unit)
connection pneumotach
connection IOS pneumotach (PT)
connection IOS head
power supply connection
protective conductor connection
LED status table for Vyntus APS

LED code system status possible action
blue yellow green status -

system start none
system ready start measurement
measurement active perform measurement
standby / PC inactive switch on the PC, exit standby
mode, plug in the USB cable
error in the application restart the system or contact the
service department
initialization error contact the service department
error in the Vyntus device contact the service department
self-test of the Vyntus device None
firmware update Wait. System restarts automati-
cally after the updates.
= LED is illuminated
= flashes slowly
= flashes quickly
Version 01.00 • 2021-02-01 Page 153/170

Esophagus Catheter
Please observe the manufacturer‘s instructions for the esophagus catheter (item
no. 705003).
Graphical Symbols
Alternating current
Earthed conductor
Potential equalization
Attention!
OFF (device disconnected from the power supply system)
ON (device connected to the power supply system)
Instructions for Use
Year of Production
Manufacturer
Applied part of Type B
CE sign with code number of the Notified Body.
Single patient use
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Use before
Disposal of electronic devices in compliance with WEEE
CAUTION:
Rx ONLY FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
Follow the instructions for use!
Serial number
Reference number
Batch code
Direct current
For indoor use only
Do not use forklift truck
Do not use hand truck
Medical device
unique device identifier
Version 01.00 • 2021-02-01 Page 155/170

Safe Gas Handling
Please observe all federal, state and local regulations for safe handlin of gases.
Measuring gases as pharmaceuticals

The European Directive 2001/83/EC and the MEDDEV 2.1/3 Rev. 5.1 lay down that
all types of measuring gas for human application are to be treated as pharmaceu-
ticals.
We therefore point out that only measuring gases which are pharmaceuticals may
be used with this Vyaire medical equipment. We recommend to use original gases
which are filled by the corresponding manufacturers.
How to use gas cylinders:

- Operate and store the device only in a location with a room size of at least
50m3 or in a well-ventilated room.
- If the measurement is interrupted or ended, the cylinder valve must be closed!
- Pressure reducers have to conform to the technical specifications (see chapter
"Technical Data") to ensure correct operation of the measurement system and
to prevent damage of the device.
- Only experienced and trained personnel are allowed to handle the gas cylin-
ders.
- Gas cylinders must be handled with care and secured to prevent tipping.
- Keep gas cylinders away from heat (e.g. heaters, radiators); gas cylinders must
not be stored in close proximity to open flames.
- Keep the valve connections clean.
- Cylinder labels must not be damaged or removed.
- Keep valves and fittings of cylinders free from oil and grease.
- Damaged gas cylinders (for example damaged valves, damages caused by fire)
must not be used. They have to be marked clearly. Ask your local gas supplier
how such cylinders are to be treated.
- Upon connecting gas cylinders, they have to be checked for damages.
- Do not use any force-increasing tools for opening or closing the cylinder valves.
How to exchange gas cylinders:

- When the gas cylinder is empty (approx. 10 bar residual pressure), close the
cylinder valve manually.
- Depressurize the system (manometer must show 0 bar).
- Loosen the connection between the valve cylinder and the pressure reducer.
- Screw the sealing nut possibly delivered with the system onto the cylinder valve.
- Screw the cylinder cap possibly delivered with the system onto the gas cylinder.
- You may now take the cylinder from the cylinder rack without risk (preventing
Page 156/170 Version 01.00 • 2021-02-01

it from tipping).
- Place the full cylinder in the cylinder rack.
- Remove the cylinder cap and the lock nut/sealing cap, if applicable.
- Follow the instruction leaflet for exchanging the sealing ring of the pressure
reducer. (Instruction leaflets and sealing rings are delivered with every gas cylin-
der delivered by Vyaire).
- Check the connection for tightness as follows:
- Briefly open the cylinder valve and close it again.
- After 5 minutes open the cylinder valve again while watching the high-pressure
manometer display. If the manometer clearly indicates a pressure reduction,
there must be a leakage.
- The high-pressure manometer display should indicate a constant pressure.
- However, a pressure reduction of approx. 30 % within 12 hours is considered
as normal.
- After tightness of all gas connectors has been checked, open the cylinder valve.
Please note: Slowly open the cylinder valve as far as possible. (The system is now
under pressure again). Turn back the cylinder valve by a 1/4 revolution of the
hand-wheel (thus preventing the valve from getting stuck).
Further leakage tests:

- Check the connection for leakage by using soap water, e.g. (leakage is indi-
cated by bubbles).
For pressure reducers with union nut: Depressurize the system and use a wrench
to slightly tighten the pressure reducer. After pressure admission check the con-
nection again by using soap water. If there is still a leak in the system, exchange
the sealing ring/O-ring) and repeat the whole check.
For pressure reducers with manual connection: Depressurize the system and ex-
change the sealing ring/O-ring. Hand-screw it, admit pressure and repeat check.
Please contact the manufacturer, if there is still a leak in the system.
Gas cylinder transportation

- Gas cylinders must be closed safely.
- Pressure reducers have to be removed.
- Sealing nuts (required for toxic and flammable gases) delivered by the gas
supplier must be screwed on the valve connector.
- Gas cylinders must only be transported if their valve is protected by an
approved valve protection (for example a cylinder cap) and they are sufficiently
secured to prevent tipping or rolling.
- When gas cylinders are being transported in an enclosed vehicle, sufficient
fresh air from outside (for example through an open window, switched on
blower, ventilated luggage space) must be ensured.
- No smoking inside or near the vehicle.
Version 01.00 • 2021-02-01 Page 157/170

Meaning of gas cylinder signs

The gas supplier has to provide the gas cylinders with complete cylinder labels
which can be read well.
The signs may have the following meaning:
Non-flammable Compressed gas Health hazard

and non-toxic gas
Connection of new gas cylinders

When a new gas cylinder has to be connected, the sealing between gas cylinder
and Vyaire pressure reducer must be replaced. Every Vyaire gas cylinder is deli-
vered together with a new sealing.
More detailed information can be found in the leaflet "Connecting the pressure
reducer to the gas cylinder" which is added to every Vyaire gas cylinder.
Notes on Using CO
Trade name: Carbon Monoxide
Chemical characteristics:
CO, carbon monoxide, very potent haemotoxin, combustible, highly
flammable, gaseous, colorless, odorless. It is fatal to inhale large
quantities of carbon monoxide. Carbon monoxide may possibly
damage the unborn fetus.
Observe the following fundamental rules and regulations.

- Adhere to all applicable trade union rules and regulations.
- Only trained personnel are authorized to perform measurements.
- The CO concentration used for the patient must not exceed 0.321 %.
- During the use of carbon monoxide the occupational exposure limit value of
30 ppm has to be observed (German limit value). The occupational exposure
limit values are country-specific, consequently different limit values apply in
other countries.
- In the case of pregnant patients it has to be decided whether the medical
benefit is higher than the risk for the fetus.
Safety measures, storage, handling:

- Store the container in a well-ventilated area.
- Protect it against flammable sources and interaction with heat.
- Close the cylinder when not in use.
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In the case of accident and fire:

- If a gas leak occurs: Air the room and always use a breathing apparatus which
is independent of ambient air.
- Substances to extinguish fire: water vapor, CO2 extinguisher, dry quenching
agent.
- First aid: Bring those who are injured into the fresh air. If breathing stops, give
mouth-to-mouth resuscitation or use a respirator. Get help from a doctor im-
mediately.
- Further information for the doctor: oxygen pressure artificial respiration (pres-
sure cabin) with pure O2 (3 - 3.5 bars), Supraenin or Pervitin is suitable.
Toxicology:
Very potent haemotoxin. During inspiration the gas combines with hemoglobin so
that oxygen cannot be absorbed (suffocation).
Toxin class 3 DL50 = 50 to 500 mg/kg
Literature:
- Notes on using CO
Hommel: Handbuch der gefährlichen Güter, Sheet 116
Kühn-Birett: Merkblätter gefährlicher Arbeitsstoffe, Sheet K19
Version 01.00 • 2021-02-01 Page 159/170

Gas concentrations and color-coding of gas cylinders

Only use the indicated min./max. gas concentrations for the individual measure-
ment procedures! For safety reasons we recommend to use ready-mixed gases
which can be purchased from Vyaire.
The Euro-Norm EN 1089-3 indicates the color-coding of gas cylinders. It represents
a new color-coding system for gas cylinders which provides additional information
Cylinder shoulder
on the characteristics of the gas in the cylinder (poisonous, flammable, oxidizing,
inert).
The color-coding according to this norm is only defined for the cylinder shoulder.
Diffusion SB Realtime and Diffusion SB Intrabreath with

Vyntus BODY with Diffusion:
Measuring gas, item no. 892566 Mix gas, 10 Liters Green
0.3 ± 0.021 % Methane (CH4)
White
0.3 ± 0.021 % Carbon Monoxide (CO)
0.3 ± 0.021 % Acetylene (C2H2) (optional)
21 ± 1.47 % Oxygen (O2)
Color code
Rest: Nitrogen
Before any maintenance activity at the system the gas bottle valve
must be closed. Then disconnect the pressure reducer from the cylinder
valve.
Access to the gas cylinders must be ensured at all times and the
fittings of the pressure reducers must be visible.
The tolerance limits of the gas concentrations have to be observed as a

nonobservance can cause an overrange of the sensor system and/or an
overexertion of the patient.
Page 160/170 Version 01.00 • 2021-02-01

Literature
IEC 60601-1: 2012 Medical Electrical Equipment,
Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment

Part 1-2: General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair
of medical electrical equipment
IEC 60364-7-710:2002, modified (DIN VDE 0100-710:2012)

Low-voltage electrical installations - Part 7-710: Requirements for special installa-
tions or locations - Medical locations
Reference source:
VDE-Verlag GmbH, Bismarckstr. 33, 10625 Berlin or Merianstrasse 29, 63069 Of-
fenbach, Germany, e-mail: kundenservice@vde-verlag.de
BEUTH Verlag GmbH, Burggrafenstrasse 6, 10787 Berlin, e-mail: info@beuth.de
Return of Goods in Medical Institutions

The chapter "Return of Goods in Medical Institutions" can be found in the
manual “Instructions for Cleaning and Disinfection of Reusable Parts”.
Version 01.00 • 2021-02-01 Page 161/170

Technical Data
Product Lifetime:
If the complete product is used and maintained in the condition it was delivered, the expected
product lifetime is at least 7 years.
Vyntus BODY Specification:

Essential performance according to IEC 60601-1 3rd Edition:
• Accuracy of flow-time measurement
• Accuracy of volume measurement
• Accuracy of mouth-pressure measurement
• Accuracy of body-pressure measurement
• Accuracy of diagnose-gas-measurement
Flow:
Vyntus BODY
Type Ultrasound
Methodological Simultaneous measurement of ultrasound transit time in and against flow direction
Peculiarities
Sample rate True 1000 Hz for flow, achieved by 2000 ultrasound transit time measurements (double
shot technology)
Range 0 to 18 L/s bidirectional
Accuracy Exhalation 0 to 14 L/s:
1.5 % or 0.05 L/s (whichever is greater)
Inhalation 0 to 14 L/s:
2.0 % or 0.05 L/s (whichever is greater)
Precision 1 % or 0.1 L/s (whichever is greater)
Resolution 1 mL/s
Total resistance <0.150 kPa*s/L at 14 L/s
(MicroGard II filter +
USS Module + FPV
block)
Dead space USS 66 mL
Module
Page 162/170 Version 01.00 • 2021-02-01

Volume:
Vyntus BODY
Type Software volume integration of flow signal (ultrasound)
Range 30 L (software limited)
Accuracy Exhalation and inhalation 0.5 to 14 L/s: 2.5% or 0.075 L (75 ml)
Precision 1 % or 0.05 L (whichever is greater)
Resolution 1 mL
Mouth Pressure:
Vyntus BODY
Type piezo resistive
Range ± 20 kPa
Accuracy ± 1 % or 0.01 kPa (0.075mmHg) (whichever is greater)
Resolution 0.003 kPa (0.225 mmHg)
Bodyplethysmograph (Vyntus BODY):

Box signal Transducer type piezo resistive calibrated in shift volume
Transducer range 0 to ± 2500 mL at 1000 hPa ambient pres-
sure
Accuracy ± 2 % at 0.25 Hz / 0.5 Hz
Resolution 0.1 mL
Compensation of ambient pressure Digital ambient pressure compensation
variations
Box calibration syringe Calibration volume 50 mL, motor-driven calibration pump
Calibration frequency 0.25 Hz, 0.5 Hz and 1 Hz
Box Material Aluminium/glass construction
Principle volume-constant
Volume 1110 L
Height step-in 70 mm
Weight 175 kg (385 lbs),
150 kg (330 lbs) without door
Door-lock Electromagnetic via 8 magnets
Size Outside 93.2 x 80 x 185 cm (incl. door knob)
Space Inside 88.2 x 70.5 x 173. 9 cm
Flexible 3D-Arm Max. length outside the cabin 63 cm
Adjustable height inside the cabin 98.3 cm to 141.5 cm
Chair Maximal load chair 150 kg (330 lbs)
Sitting height adjustable from 40 to 60 cm
Turnable yes
Material seatshell Polypropylene
Version 01.00 • 2021-02-01 Page 163/170

Bench Maximal load bench 250 kg (551 lbs)

Sitting height 47,6 cm (18,7“)
Sitting area 50.6 cm W x 33.0 cm D (19.9“ x 13.0“)
Material bench POM (Polyaxymethylene)
turnable no
Multigas analyzer (CO/CH4) - Diffusion Measurement: (Vyntus BODY with Dif-

fusion)
Type Infrared
Range 0 to 0.33 vol %
Accuracy ± 0.003 vol % or ± 2 % relative (whichever is greater)
Resolution 0.0005 vol %
T10-90 Sensor ≤ 145 ms
Pressure reducer (Diffusion pressure reducer for demand valve - Vyntus BODY
with Diffusion):
Inlet pressure 200 bar
Outlet pressure 7 bar (fixed)
Flow rate at least 500 L/min
at most 700 L/min
2 outlets G 1/4 internal screw thread
Vyntus APS Specification:

Essential performance according to IEC 60601-1 3rd Edition:
• Accuracy of nebulizer performance
Compressor flow 8 L/min ± 1.5 L/min

Compressor pressure 1.4 bar ± 0.3 bar
Nebulizer Philips Respironics Sidestream®
Type Compressed air nebulizer
Mean mass diameter 3.2 µm
Output power 240 mg/min
Ambient Unit Specification (Vyntus BODY)

Ambient measurement Measurement range Accuracy
Temperature sensor – 10 to +50 °C (14 to 122 °F) ±0.5 °C at 20 °C (68°F)
±1 °C at 10 to 34°C (50 to 93.2°F)
Humidity sensor 0 to 100 % relative humidity 4 % relative humidity at 20 - 80 %
relative humidity
Air pressure sensor 500 to 1100 hPa (375 to 825 ± 2.5 hPa (1.88 mmHg) at 700 to
mmHg) 1060 hPa (525 to 795 mmHg)
Page 164/170 Version 01.00 • 2021-02-01

Calibration Syringe Specification:

Volume 3L
Accuracy 0.4 %
Power Supply:
Vyntus BODY (cabin)
Mains voltage 100 to 240 V, AC 50 to 60 Hz
Power input max. 80 VA
Electrical safety Protection class I
Mains plug Used for isolating all poles simultaneously from supply mains
Vyntus CART 3.b or desktop version with PC/Monitor/Printer (Vyn-

tus BODY)
Mains input voltage 100 to 240 V, AC 50 to 60 Hz, max. 1.5 A
Power input max. 1.5 A (depending on PC / notebook)
Vyntus CART 3.0N / 3.1N

Mains input voltage 100 - 120 V AC, 50 / 60 Hz
220 - 240 V AC, 50 / 60 Hz
Power input 630 VA
Primary Fuse 220 - 240 V 2 x T3.15 A L / 250 VAC
Primary Fuse 100 -120 V 2 x T6.3 A L / 250 VAC
Power Supply:
Vyntus APS,
Vyntus Power Module
Type Magic Power MPM-X125
Mains input voltage 100-240 V, AC 47-63 Hz
Power consumption 1.5 - 1 A
Output voltage 24 V DC
Output 120 VA / 5 A
Version 01.00 • 2021-02-01 Page 165/170

Moisture protection:
Vyntus APS IP 20
Vyntus CART 3.b no IP protection
Vyntus CART 3.0N, 3.1N no IP protection
Vyntus BODY IP 20
Ambient conditions:
Altitude: ≤ 3000 m
Temperature: +10 °C to +34 °C (+50 °F to 93.2 °F)
Rel. humidity: 20 to 80 % RH, non-condensing
Ambient pressure: 700 to 1060 hPa (525 to 795 mmHg)
Transport and storage conditions:

Temperature: -20 °C to +50 °C (-4 °F to 122 °F)
Rel. humidity: 15 to 95 % RH, non-condensing
Ambient pressure: 600 to 1200 hPa (450 to 900 mmHg)
Classification of applied parts:
Vyntus APS Applied Part Type B

Vyntus BODY Applied Part Type B
Category according to MDD 93/42/EEC (2007):
Complete system: Active class IIa medical product
Operating mode:
Complete system Continuous operation
MicroGard II Series:
• lnspiratory Resistance: < 0.4 cm H2O/L/S at 1 L/S

• Expiratory Resistance: < 0.4 cm H2O/L/S at 1 L/S
• Filtering Efficiency against cross contamination: Bacterial: > 99.999 % (based on Nelson Lab test)
Viral: > 99.999 % (based on Nelson Lab test)
• Filter Volume: 55 mL, including adapters and housing
• Connections: 30 mm ID. 30 mm OD. Tapered ports
• Connections (filter with integrated mouthpiece): 30 mm ID. Tapered port
• Single patient use
• Latex-free product
Page 166/170 Version 01.00 • 2021-02-01

Item Numbers of Disposables, Spare Parts and Accessories
Use only Vyaire approved accessories and spare parts.
Part Number Description Class

V-892230 Mouthpiece Silicone Children, pack of 5 (applied part) IIa
V-892235 Mouthpiece Silicone Adult, pack of 5 (applied part) IIa
892103 Plastic mouthpiece, single use, 25 pieces (applied part) IIa
S773470 Silicone mouthpiece FreeFlowTM, 12 pieces (applied part) IIa
V-892894 Mouthpiece (disposable mouthpiece blue), 180 pieces (applied part); single use IIa
V-720000 QM syringe 3L with integrated ventilator Im
720254 Manual calibration syringe, 3 L Im
852740 Silicone sleeve, 60 mm for manual calibration syringe, 3 L -
V-861449 Silicone adapter “Oval” for MicroGard IIB -
852353 Adapter ID 30 mm to ID 30 mm -
V-892895 Nose-clip (reusable), 5 pieces (applied part) I
V-892900 Nose-clip (disposable), 10 pieces (applied part) I
892121 Nose Clip Pad,Single Pat, 100 pieces; single use I
V-892384 MicroGard IIC, 50 pieces (applied part); single use IIa
V-892381 MicroGard IIB with integrated mouthpiece, 50 pieces (applied part); single use IIa
V-892391 Filter kit MicroGard type IIB, 80 pieces (contains applied parts); single use IIa
V-892392 Filter kit MicroGard type IIC, 80 pieces (contains applied parts); single use IIa
Vyntus APS
V-892020 APS AirLife® filter, 50 pieces IIa
V-707307 APS connection block V2 for Sidestream I
V-707540 Nebulizer set disp. Sidestream® with 10 disposable nebulizer vessels and pressur- I
ized air tube
V-892608 Nebulizer Sidestream disposable, 50 pieces IIa
845579 Nebulizer end cap Medic-Aid -
Vyntus BODY
V-707377 USS Module with adapter and protective cover I
V-707380 USS MicroGard Adapter I
V-707384 Cable port protective cover, 5 pieces -
V-707389 FPV block -
V-707388 FPV shutter mechanism -
V-707390 FPV silicone valves, 5 pieces -
V-707397 FPV X-Ring Kit consists of 3 x X-ring and 1 x small rod -
V-707383 USS Module holder -
V-707393 FPV block holder -
Version 01.00 • 2021-02-01 Page 167/170

Vyntus BODY with Diffusion

V-707381 USS MicroGard Adapter for gas sampling -
V-852556 Drying Tube ME serie 48 inch -
892566 Mix gas 0.3 % CO, 0.3 % CH4, 0.3 % C2H2, 21 % O2, Rest N2, 10 -
Liters (gas for diffusion measurement)
892542 Gas cylinder 10 Liters (for gas 892566) -
892566R Medical mix gas 0.3 % CO, 0.3 % CH4, 0.3 % C2H2, 21 % O2, Rest N2, 10 -
Liters (gas for diffusion measurement - only for Germany)
892570 Gas cylinder 10 Liters (for gas 892566R) -
SNIP and Rhinomanometry
892137 Nose adapter, size 1, 50ea/pk (applied part) IIa
852715 Face mask for Rhinomanometry size 5, (applied part) IIa
852718 Face mask for Rhinomanometry size 3, (applied part) IIa
V-707723 Cone Adapter with hole (Rhino) I
V-708052 Connection set (consists of 852367, V-852039, 852635, and 852633) I
Compliance
705003 Esophagus Catheter Set, 5 pieces (applied part) I
(Esophagus Catheter is distributed by Vyaire) IIa
Power cables
918208 Power line UK H05 VV-F3G acc. to IEC 227 and IEC 245 -
918100 Power line EU H05 VV-F3G acc. to IEC 227 and IEC 245 -
918209 Power line SA H05 VV-F3G acc. to IEC 227 and IEC 245 -
918399 Power line AUS H05 VV-F3G acc. to IEC 227 and IEC 245 -
S760707 Power line US AWG16 acc. to UL and CSA -
V-918155 Power line KOR H05 VV-F3G acc. to K60227-5, K60320-1 and KSC 8305 -
V-918490 Power line JAP HVCTF 3x2.0mm² acc. to IEC 320/13 and JIS 8303 -
Hygiene
845117 Instrument tub with lid, 210 x 110 x 35 mm -
V-707394 Disinfection tray insert -
The SentrySuite Software includes a detailed Disposables and Accessories Catalog

which can be loaded by clicking on the “?“ in the menu bar.
Page 168/170 Version 01.00 • 2021-02-01

Global Customer Support:

+49 931 4972-127 tel
+49 931 4972-62127 fax
Email: support.rt.eu.jae@Vyaire.com
For ordering accessories:

+49 931 4972-365 tel
Vyaire Medical GmbH

Leibnizstrasse 7
97204 Hoechberg
Germany
+49 931 4972-0 tel
+49 931 4972-423 fax
www.Vyaire.com
Version 01.00 • 2021-02-01 Page 169/170

G LO B A L
HEADQUARTERS AUSTRALIAN SPONSOR
V ya i re M e d i c a l , I n c. V ya i re M e d i c a l G m b H V y a i re M e d i c a l P t y L td
2 61 2 5 N o r t h R i v e r w o o d s B l vd Le i b n i zs t ra ss e 7 S u i te 5.03, B u i l d i n g C
M e tta w a , I L 6 0 0 4 5 9 7 2 0 4 H o e c h b e rg 1 1 Ta l a v e ra Ro a d
USA Germany M a c q u a r i e Pa r k , N SW 2 1 1 3
A u st ra l i a
v yaire.co m
© 2 0 2 1 V y a i re M e d i c a l , I n c. o r o n e o f i ts a f f i l i a tes . A l l r i g h ts res e r v e d . V y a i re, t h e Vy a i re M e d i c a l l o g o a n d a l l o t h e r
t ra d e m a r ks a re t ra d e m a r ks o r re g i s te re d t ra d e m a r ks of Vy a i re M e d i c a l , I n c. o r o n e of i ts a f f i l i a tes . M e d i c a l d ev i c e s
c l a ss I I a a c c o rd i n g to M e d i c a l D e v i c e s D i re c t i v e 93 / 4 2 / E E C. P l e a s e re a d t h e c o m p l e te I n s t r u c t i o n s F o r U s e t h a t
c o m e w i t h t h e d e v i c e s o r fo l l o w t h e i n s t r u c t i o n s o n t h e p ro d u c t l a b e l i n g .

V-781381-320 - IFU - VyntusBody - V 01.00 EN

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Instructions for Use

Subject to technical modifications.

Page 2/170 Version 01.00 • 2021-02-01

Version 01.00 • 2021-02-01 Page 3/170

Provocation protocol with more than one measurement application................. 130

Page 4/170 Version 01.00 • 2021-02-01

System Configuration Vyntus BODY

Vyntus CART 3.b Vyntus BODY with chair

Vyntus CART 3.1N Vyntus BODY with bench

Version 01.00 • 2021-02-01 Page 5/170

The Vyntus BODY is a whole-bodyplethysmograph and consists of a spacious

A combination with other Vyntus devices is available. Further information regard-

The Vyntus BODY cabin is directly connected to a separate wall socket.

Page 6/170 Version 01.00 • 2021-02-01

System Configuration Option Vyntus APS

Extended Basic Module

Vyntus APS inside the cabin

The software-controlled Vyntus APS (Aerosol Provocation System) allows easy

Vyntus APS is connected to a medical power supply (Magic Power MPM-X125)

Version 01.00 • 2021-02-01 Page 7/170

Indications for Use and Usability

Indications for Use:

The patient’s case history has to be matched with the contraindications

The application of this system is restricted to authorized and trained personnel

Page 8/170 Version 01.00 • 2021-02-01

Version 01.00 • 2021-02-01 Page 9/170

A qualified physician has to reassess all Vyntus/SentrySuite measurements. An

FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A

Page 10/170 Version 01.00 • 2021-02-01

Symbols for Notes on Safety in Instruction Manuals

DANGER indicates an imminently hazardous situation which,

WARNING indicates a potentially hazardous situation which,

CAUTION indicates a potentially hazardous situation which,

Additional icons shown in the instruction manual:

See instruction manual and documents delivered with the

Important and useful information. Information does not warn

Hints for use.

The original document of the Declaration of Conformity can be found in the

Version 01.00 • 2021-02-01 Page 11/170

Switching on/off Vyntus BODY/Vyntus APS

Page 12/170 Version 01.00 • 2021-02-01

CART 3.0N / 3.1N

CART 3.0N / 3.1N

Switching on / off the CART has no influence on the Vyntus BODY as it is

Version 01.00 • 2021-02-01 Page 13/170

USS Module - Ultrasonic Sensor

USS MicroGard Adapter

Please make sure that the two

Prior to connecting the MicroGard filter, hygienic hand disinfection must be

Page 14/170 Version 01.00 • 2021-02-01

The Start Screen/ Home Page

After switching on the unit, a self-test is automatically performed verifying

Version 01.00 • 2021-02-01 Page 15/170

The calibration check required for the measurement to be performed at regular

A description of the calibration and of all measurement programs is part of this

Page 16/170 Version 01.00 • 2021-02-01

Short description of the icons:

Utilities: What is it used for?

The operator is responsible for the change of predicted modules, authors or

Version 01.00 • 2021-02-01 Page 17/170

Page 18/170 Version 01.00 • 2021-02-01

Measurements with the MicroGard Filter

To ensure optimal patient safety, use the MicroGard filter. Before