Care Fusion Vyntus WALK User manual

V-781338
Version 05.00
English
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Instructions for Use
Mode d‘emploi
Gebrauchsanweisung
Instrucciones de uso
Istruzioni per l‘uso
Gebruiksaanwijzing
Brugermanual
Instruções de Utilização
Vyntus WALK

Instructions for Use................................................................................... 4
Mode d‘emploi ....................................................................................... 45
Gebrauchsanweisung.............................................................................. 86
Instrucciones de uso.............................................................................. 127
Istruzioni per l‘uso................................................................................. 168
Gebruiksaanwijzing............................................................................... 209
Brugermanual....................................................................................... 250
Instruções de Utilização......................................................................... 291

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Contact:
CareFusion Germany 234 GmbH
Leibnizstrasse 7
97204 Hoechberg, Germany
[phone] tel
[phone] fax
E-Mail: [email protected]
This manual has been composed with the assistance of Adobe®Creative Suite®
programs Adobe InDesign®, Adobe Photoshop®, Adobe Illustrator®and Adobe
Acrobat®. The complete pages have been produced with Adobe InDesign®CS5.5
for PC and are also available as PDF les. Adobe Acrobat Reader is required in
order to open these PDF les.
Trademarks
Windows is either a registered trademark or trademark of Microsoft Corporation in
the United States and/or other countries.
Adobe, Creative Suite, InDesign, Photoshop, Illustrator and Acrobat are registered
trademarks of Adobe Systems Incorporated in the USA and/or other countries.
Nonin and WristOx are registered trademark of Nonin Medical Inc.
Copyright
All rights, also those of translations, are reserved. Written permission of
CareFusion shall be obtained for the reproduction of the manual or an excerpt
thereof by any means which includes printing, photostatic duplication, microlms
or any other process.
Note
This document contains information protected by copyright. All rights reserved.
Written permission of CareFusion shall be obtained for copying, reproduction
or translation to another language. CareFusion reserves the right to change any
information of this manual without prior notice.
Names of individuals used in the examples are ctitious. Any similarities to living or
deceased individuals are therefore purely coincidental and not intended.
Technical changes reserved.
Copyright © 2017 by CareFusion Germany 234 GmbH, Hoechberg, Germany

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Table of Contents
The Vyntus WALK 6-Minute Walk Test.................................................................6
Vyntus WALK Overview .......................................................................................6
Indication for Use.................................................................................................7
Contraindications.................................................................................................7
Intended Use and Usability...................................................................................7
Symbols and Notes on Safety in the Instructions for Use.......................................8
Declaration of Conformity....................................................................................9
Practical Advice....................................................................................................9
Minimum Requirement ......................................................................................10
Scope of Delivery ...............................................................................................10
Startup ..............................................................................................................10
Pairing Oximeter ................................................................................................11
Login .................................................................................................................12
Login - “Standalone” Mode..........................................................................12
Login - “SentrySuite connected” and “HIS connected” Mode....................... 13
Settings .............................................................................................................14
Activate Extended Settings............................................................................14
“Standalone” Mode Settings ........................................................................16
“SentrySuite connected” and “HIS connected” Mode Settings .....................18
Preparing the Measurement...............................................................................19
Login and Entering Patient Data (“Standalone” Mode).......................................20
Login and Loading Patient Data (“SentrySuite connected” and “HIS connected”
Mode)................................................................................................................21
Measurement ....................................................................................................22
Phase 1 „Baseline“ ......................................................................................22
Phase 2 “Testing“.........................................................................................26
Phase 3 “Recovery“......................................................................................31
Phase 4 “Results“.........................................................................................32
Ending the measurement...................................................................................33
Ending the measurement - “Standalone“ Mode ...........................................34
Ending the measurement - “SentrySuite connected” and “HIS connected”
Mode ...........................................................................................................35
BODE-Index .......................................................................................................36
Potential Sources of Errors and Correctives.........................................................36
Surface Cleaning and Disinfection......................................................................37
Notes on Safety and Operating ..........................................................................37
Additional Notes on Safety for Vyntus WALK ....................................................40
General..............................................................................................................40
Literature........................................................................................................... 41
Item Numbers of Disposables, Spare Parts and Accessories.................................41
Specications.....................................................................................................42
Contacts............................................................................................................ 44

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The Vyntus WALK 6-Minute Walk Test
The 6-Minute Walk Test determines the physical tness of patients suffering from
chronic lung disease and heart insufciency. The test is non technical and can be
easily understood by the patient. It is suitable for monitoring the medical
condition as well as the therapeutical benet of a treatment. The SpO2 and heart
rate values measured by a ngerclip and the total distance covered during the walk
test provide information about the physical tness of the patient.
Tablet PC SentrySuite or HIS
Database
Nonin Sensor 3150 WristOx™ Oximeter
Vyntus WALK Overview
With the use of Vyntus WALK, patient‘s SpO2 and heart rate values are measured,
transferred to a Tablet PC via Bluetooth and, if applicable, saved via WLAN in the
SentrySuite database or the Hospital Information System “HIS”, respectively.
Patients suffering from lung diseases often have poor oxygen perfusion from
the blood to the lungs. This can result in a low oxygen saturation (SpO2).
Patients with a low oxygen saturation due to illness need to be observed
particularly during the 6-Minute Walk Test.
The standard value of oxygen saturation is 95 to 100%, a value below 90%
becomes critical.
For instructions on how to interface with SentrySuite, please refer to the document
“Vyntus WALK SentrySuite Interfacing”.

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Indication for Use
Vyntus WALK is a mobile medical application which is intended to be used on a mobile platform to
collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry
data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform
has access to a host computer with SQL database (SentrySuite) via a wireless network for further
data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing
they can cooperate with the test instructions. Measurements are performed under the direction of
a physician in a hospital environment, physician’s office or similar setting (professional healthcare
facilities).
In order to ensure correct use, this device may only be used by authorized individuals and specially
trained personnel.
Information on Usability:
Ambient requirements:
- Use of the medical product in a medical environment (e.g. doctor‘s ofce, clinic, hospital)
- Communication with the patient must be ensured (e.g. eye contact, duty of care)
- Ambient conditions see section “Technical Data“
Operator 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 recommended)
Patient requirements:
- Adequate patient cooperation is ensured
- Use with patients > 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.
The medical history of the patient should be checked to ensure there are no contraindications to
performing the test.
See the ATS and ERS recommendations for further information:
http://www.thoracic.org/statements/resources/pft/sixminute.pdf
Intended Use and Usability
Contraindications

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Symbols and Notes on Safety in the Instructions for Use
Based on the ANSI recommendations (American National Standards Institute) for
notes on safety, following symbols were used in this Instructions for Use:
Additional symbols displayed in the Instructions for Use:
X X Note the Instructions for Use and accompanying documents.
Important operation instructions and useful information. No
information warning of dangerous or critical situations.
Advice, information and operation instructions.
Degree of Danger Personal
Damage
Material
Damage Used at:
X
DANGER refers to an immediate situation of danger, which,
when not avoided, can result in serious injuries or death. This
signal word is reserved to extreme situations.
XWARNING refers to a potential situation of danger, which,
when not avoided, can result in serious injuries or death.
X (X)
CAUTION refers to a potential situation of danger, which,
when not avoided, can result in slight or minor injuries. This
symbol is also used as a reference to insecure procedures.
Please observe the notes on operating and safety instructions as well
as the technical data described in the enclosed Instructions for Use for
Nonin and Tablet PC.

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Declaration of Conformity
The original document of the Declaration of Conformity can be found in the
Accompanying Documents.
Practical Advice
ACCORDING TO THE US FEDERAL LAW, THESE DEVICES MAY ONLY BE SOLD BY
OR ON THE ORDER OF A PHYSICIAN.
(Rx only)
Make sure you are procient in the safe handling of the medical device and
become familiar with the procedure of the examination.
Instructions to the patient:
Most of the patients will not have performed a 6-Minute Walk Test yet. They,
as well as experienced patients, might be excited and nervous. To optimise the
results, the Walk Test should be explained to the patient in detail concerning the
time and the objectives of the measurement.
Preparation of the patient
1. The patient should wear comfortable clothes.
2. The patient should wear appropriate shoes.
3. If applicable, patients should use their walking aids (walking stick, walker
rollator) during the test.
4. The usual medication of the patient should be maintained.
5. The patient is allowed to have a small meal early in the morning or in the
mid morning prior to the measurement.
6. Patients should not have exercised 2 hours prior to the start of the
measurement.

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Startup
Insert batteries in the battery compartment of the oximeter.
The tablet should be fully charged before startup.
We recommend not to perform a measurement when the battery indicator
shows <15% and to charge the mobile platform since interrupted
measurements will not be saved.
Do not perform a measurement during charging process.
Scope of Delivery
The scope of delivery contains:
- Nonin Sensor 3150 WristOx Oximeter incl. Soft Sensor Medium
- Tablet PC incl. accompanying documents
- Oximeter accompanying documents
- Charger for Tablet PC
- Instruction for Use Vyntus WALK
- Adapter unit for Europe, UK, USA and Australia
Instructions for Use
Vyntus WALK
USB cable and charger
for Tablet PC
Nonin Sensor 3150 WristOx
Oximeter incl. Soft Sensor Medium
Tablet PC
Minimum Requirement
Network (WLAN):
Minimum connection speed should be 150 Mbit/s in WLAN-environment.
Virus scanner
CareFusion does not validate or test any virus scanner. The operator is responsible
for an installation of virus scanners.
System Updates
CareFusion validates and tests system updates of the respective software version
until the date of publication. Updates appearing later are not validated and
released . The operator of the medical devices is responsible for an installation of
later updates.
Installation of Third-Pary Software
CareFusion does not validate or test any third-party software and updates,
respectively. The operator is responsible for an installation of third-party software.
The scope of delivery may vary in different countries. Please check the contents
checklist with your delivery.

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Pairing Oximeter
Open the menu window by pulling down the right upper “corner“.
Tap on “settings“ to open the menu item “Bluetooth“.
Activate Bluetooth by tapping
“ON“ and touch the “Bluetooth“
eld in order to search for active
devices a Bluetooth connection
can be established with.
Select the Nonin device by
touching as soon as it is
recognized. In order to establish
a connection between both
devices, a PIN code is required.
This code is found on the back
of the pulse oximeter.
With different device types, the
PIN might be located elsewhere.
The oximeter (and with it, the
Bluetooth connection) is started as
soon as the sensor is put on.

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1. Switch on the tablet PC (language selection is automatically made via
the tablet system language).
2. Tap on the Vyntus WALK App icon.
The startup-screen appears automatically.
Login
Login - “Standalone” Mode
PIN: Protect the App from
unauthorised access with a PIN.
login: Login
settings: one-time settings
Enter the PIN-Code and conrm
with <OK>.
The connection between the
devices has to be established once
during installation or, if applicable,
after the replacement of the tablet
PC or pulse oximeter.

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List of users logged in
last
Currently logged-in user
A program description (user rights management) is not given in this Instructions for
Use. For a detailed description please refer to the SentrySuite Online Manual.
Login - “SentrySuite connected” and “HIS connected” Mode
Password: Protect the App from
unauthorised access with a
password.
login: Login
settings: one-time settings

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Before starting up the system for the rst time, one-time presettings need to be
made in the <settings>tab:
Settings
It is also possible to activate the Extended Settings allowing the user to choose
between a test duration of 6 minutes and 20 minutes.
To activate the Extended Settings, tap on “Service” in the “ABOUT” section of
the Settings screen. Following window appears:
Tap the “Version” eld 5 times.
Activate Extended Settings
(Screen display depends on the currently
selected mode of operation)

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Conrm the activation in the following window by tapping <Yes>.
As soon as the Extended Settings mode
is activated, the “Test duration” eld
appears in the “APP SETTINGS“ section of
the Settings screen.
To switch between a test duration of 6 minutes and 20 minutes, tap the “Test
duration” eld. Following window appears:
Select the desired test duration by tapping.
Please note that selecting the test duration of 20 minutes will deactivate all
parameters and instructions concerning the 6-Minute Walk Test.
In order to deactivate the Extended Settings and, with it, the option to set the test
duration to 20 minutes, proceed as described above.

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“Standalone” Mode Settings
6MWT SETTINGS
Enter the distance of a lap in meters (m) in the “Lap distance“ eld.
In the “RPE Scale Type“ eld you can choose between a 10 level RPE scale
(“RPE CR10“) and a 20 level RPE scale (“RPE CR20“).
In the “Predicted Values“ eld you can choose the author for the calcula-
tion of predicted values. (Preset: “Enright PL, 2003”) (applies to “Standalone”
mode, only).
In the “Pause Texts“ section you can add individual texts for pauses to the
predened xed pause texts “Dyspnea“, “Hyperventilation“ and “Rest“.
In the “Event Texts“ section you can add individual texts for events to the
predened xed event texts “Desaturation“ and “O2 Change“.
Swipe left in the respective text eld to delete previously entered
“Pause Texts“ or “Event Texts“.
In the “Report Header“ section it is possible to customise the header of the
PDF-Report generated after the test (applies to “Standalone” mode, only).
APP SETTINGS
Set “Standalone“ mode of operation in the “Mode of operation” eld.
In the “PIN Code“ eld you can set an individual PIN-Code to protect the App
from unauthorised access (applies to “Standalone” mode, only).
If “Extended Settings” is activated, the additional eld “Test duration”
appears allowing the user to choose between the test duration of “6 Minutes”
and “20 Minutes” (see “Activate Extended Settings”).

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NETWORK SETTINGS
To activate the “USB Tethering” option, tap on the OFF/ON switch. If USB
Tethering option is activated, see option “b)” below for details on how to
create a report network folder.
ABOUT
In the “Activation“ eld you can activate your device by means of an
activation code.
The “Service” section contains information on the Software and the
Manufacturer and allows to activate/deactivate the Extended Settings (see
chapter “Activate Extended Settings”).
In this folder, the reports generated right after the measurement will
automatically be saved. With tapping <Test connection>, a test le will be
created and saved in the report network folder just created.
Enter the “IP Address” (e.g.
“192.168.42.101”) you want
the folder to be saved to.
Enter the name of the
authorised user and the
respective password.
To create a report network folder, tap the “Report Network Folder“ eld.
a) USB Tethering option deactivated
The REPORT NETWORK FOLDER window appears:
Enter the Domain (optionally)
and the name of the folder.
In this folder, the reports generated right after the measurement will
automatically be saved. With tapping <Test connection>, a test le will be
created and saved in the report network folder just created.
The “IP Address” eld is
lled automatically.
Enter the name of the
authorised user and the
respective password.
b) USB Tethering option activated
The REPORT NETWORK FOLDER window appears:
Enter the Domain (optionally)
and the name of the folder.
The IP Address entered
needs to be permanently
set in the network adapter
once. This requires a USB
connection between tablet
and PC.

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“SentrySuite connected” and “HIS connected” Mode Settings
Please make sure that in “SentrySuite connected” mode of operation the
tablet PC is in the same SentrySuite network and has the latest Sentry Mobile
Data Service installed and that in “HIS connected” mode of operation the
tablet PC is in the same HIS-Network.
NETWORK SETTINGS
To activate “USB Tethering” option, tap on the OFF/ON switch.
If USB Tethering is activated, the IP Adress eld described below will disappear.
Enter “5311“ in the “Port“ eld.
Enter the IP-address (e.g.
192.168.0.1) of the server the
Vyntus WALK Sentry Mobile Data
Service (or in “HIS connected”
mode, the HL7 Gateway) is
installed on (e.g. SentrySuite
Server).
Tap on <Test connection> to
check the connection with the
specied network.
APP SETTINGS
Set “SentrySuite connected“ or “HIS connected” mode of operation in the
“Mode of operation” eld, respectively.
If “Extended Settings” is activated, the additional eld “Test duration”
appears allowing the user to choose between the test duration of “6 Minutes”
and “20 Minutes” (see “Activate Extended Settings”).
6MWT SETTINGS
Customisation of the tablet for the 6-Minute Walk Test is mostly the same as
for the “Standalone” mode.
ABOUT
See settings in “Standalone” mode.
Please check that the total distance matches the stored settings before carrying out
the 6-Minute Walk Test.
To change the network settings, tap on the “IP Address“ eld (not available if
USB Tethering option is activated).
The IP-ADDRESS window appears:

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Preparing the Measurement
Attach the Nonin Sensor to the left or right wrist and put the SpO2 sensor on the
respective index nger (see picture).
As soon as the SpO2 sensor is put on, the Nonin
Sensor starts automatically with SpO2 and heart
rate shown on the display. If the SpO2 sensor
is removed, the Nonin sensor will switch off
automatically after a preset time.
Make sure that the Nonin WristOx2™ Model 3150 bracelet is closed and that
the device does not move excessively during measurement.
Do not let the mobile platform fall, if this occurs the correct functionality
cannot be guaranteed.

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Login and Entering Patient Data (“Standalone” Mode)
Tap on <login> in “Standalone” mode. Following window will appear:
Enter the patient’s ID, rst name, middle name (if applicable) and last name in the
PATIENT DEMOGRAPHICS section. These entries and the picture (if applicable)
will be shown in the upper left screen area during the entire measurement.
In addition, enter the patient’s height, weight, date of birth as well as the patient’s
gender. The Body Mass Index (“BMI”) will automatically be calculated from the
entered height- and weight values.
Touch <Next> to proceed to Phase 1 “Baseline”.
Tap on the empty eld to take a
real-time picture of the patient.