Vitalograph In2itive e-Diary User manual

In2itive e-Diary
Instructions for Use
MODEL 2120
© Copyright Vitalograph 2020 Current Edition (Issue 2, 25-Aug-2020) Cat. No. 09180

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Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.co.uk
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, International
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.eu
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.de
Technical Support
Telefon: [phone]
E-mail: [email protected]
Vitalograph Inc.
13310 West 99th Street
Lenexa, Kansas, 66215
USA
Toll Free: 800 255 6626
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.com
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph (Ireland) Ltd
Gort Road Business Park
Ennis, Co Clare, V95 HFT4
Ireland
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.ie
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, Hong Kong/China
P.O. Box 812
Shatin Central Post Oce
Hong Kong
E-mail: [email protected]
www.vitalograph.cn
Technical Support
Tel: [phone]
Email: [email protected]
© Copyright Vitalograph 2020
Current Edition (Issue 2, 25-Aug-2020)
Cat. No. 09180
Vitalograph is a registered trademark.
Vitalograph Branch Addresses

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Contents
1. Main Components ................................................................4
1.1. Features ................................................................5
2. Set Up and Return ................................................................5
2.1. Downloading data after the device is returned
to the site by the subject: ....................................7
3. Operating Instructions..........................................................8
3.1. Main Menu ............................................................9
3.2. Subject Operating Instructions .........................10
3.3. Calibration Verication.......................................13
3.4. Cybersecurity Considerations............................15
4. Power Management ...........................................................16
4.1. Battery Pack.......................................................17
4.2. Battery Power Indications ..................................18
4.3. Power Save Mode...............................................18
5. Cleaning & Hygiene.............................................................18
5.1. Preventing Cross-Contamination of Subjects...18
5.2. Inspection of the Vitalograph 2120 In2itive
e-Diary..................................................................19
6. Fault Finding Guide.............................................................20
6.1. Software Check...................................................21
6.2. Product Useful Life Checks................................21
7. Customer Service................................................................21
8. Consumables and Accessories .........................................22
9. Disposal...............................................................................22
10. Explanation of Symbols......................................................22
11. Description of the Vitalograph 2120 In2itive e-Diary ........23
11.1. Indications for Use..............................................24
12. Technical Specication ......................................................25
13. Contraindications, Warnings, Precautions and
Adverse Reactions..............................................................28
14. CE Notice.............................................................................31
15. FDA Notice ..........................................................................34
16. EU Declaration of Conformity.............................................35
17. Guarantee ............................................................................36

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1. Main Components
The main components are:
Figure 1: Device Components
1 Spirotrac® running on a PC or COMPACT
2 Power (On/Off) Button
3 Mini USB Port
4 Plinth
5 Flowhead
6 Flowhead Mouthpiece
7 LCD/Touch Panel Display
Either a PC or a Vitalograph COMPACT Expert medical workstation
is required to run the Spirotrac application and to interface the
device with the Vitalograph web portal.
Note: PC/COMPACT not included with the device.
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3
4
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1.1. Features
The features include:
• Congurable
• Storage of questionnaire results and spirometry tests
• Touch screen colour display
• Portable
• Fleisch type pneumotachograph owhead
2. Set Up and Return
The Vitalograph 2120 In2itive e-Diary is a clinical trial device and
should be set up for a subject by a healthcareprofessional prior to
use. The subject then takes the device home. Study site instructions
include specic detail on device set up, based on the requirements
for the device being used in the study.
Subject information must be created on Spirotrac prior to setting up
the device. For full instructions on using the Spirotrac application
please refer to the site-specic instructions provided and Spirotrac
Instructions for Use.
Note: A high power USB port capable of supplying 500mA is required
for charging over USB.
1. The device should be fully charged prior to rst use, using the
power pack supplied or via USB connected to the study PC or
COMPACT Expert. A full charge takes 5 hours.
2. Preparing the device for use:
a. Power on the COMPACT/PC running Spirotrac.
b. Log in using the username and password combination
provided for the Vitalograph web portal (communicated by
email).
c. Turn on the device. When prompted use the USB cable
provided to connect the device to a USB port on the
COMPACT/PC running Spirotrac.
Note: The rst time the device is used, the text on screen may not be
in the correct language, but this will update once set up is complete.
d. Select ‘Skip’.
e. Wait for ‘Begin’ todisplay at the bottom of the device screen.

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Do not enter a PIN at this point.
f. On the device, select the ‘Congure/Download’
e-Diary icon.The download dialog displays.
g. On the COMPACT/PC select ‘Connect’ to enter
remote mode on the device, as in Figure 2.
Figure 2: Connecting the device to the Vitalograph web portal
h. At rst time set up, the user is informed that the device is
blank. Select ‘OK’ to continue to create a new subject.
i. At the ‘Congure Subject’ screen, ‘Congure new Subject’ is
selected by default. (The ‘Continue with same subject’ option
is disabled because the blank device has no data.)
j. Select correct subject from the list, then select ‘Congure’.
Note: When the device is congured it updates with the latest
rmware. This may take several minutes. The device must not be

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disconnected while updating as this may permanently damage the
device.
k. A message conrms when update is complete.
l. The device automatically downloads subject ID, date, time,
and the selected language, for the selected subject.
m. The device is now set up for the subject to use. Select ‘Close’.
It may be disconnected from the COMPACT/PC.
n. Turn on the device using the On/Off button. The screen
shows the study name, study number and subject ID.
o. Check that the details are correct (i.e. that the device has
been set up for the correct subject on the correct study). If
details are incorrect, congure the device again by repeating
the instructions above.
p. Thedevice is now ready. It may be given to the assigned
subject once the subject PIN number has been assigned and
subject has been trained to use the device.
Note: If the subject is issued with a device congured with the wrong
subject number this could cause both subjects’ baselines to be
incorrect for the entire study.
Note: If the device has just been unpacked or transported, ensure
that it is left sitting, fully powered to reach room temperature prior
to testing.
3. Downloading data after the device is returned to the site by the
subject:
a. Power on the COMPACT/PC and log in to the Vitalograph
web portal using the username and password combination
provided by email.
b. Turn on the device. When prompted use the USB cable
provided to connect the device to a USB port on the
COMPACT/PC running Spirotrac.
c. Select ‘Skip’.
d. Wait for ‘Begin’ to display at the bottom of the device screen.
Do not enter a PIN at this point.
e. Select the ‘Congure/Download’ e-Diary icon.The device
download dialog displays.
f. Select ‘Connect’ to enter remote mode on the device as

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shown in Figure 2.
g. A message conrms when the download is complete. Select
‘OK’.
h. Three options show on screen: ‘Continue with Current
Subject’ (selected by default), ‘New Subject’ and ‘No Subject
(Blank e-Diary)’. No action is required.
i. When ‘Close’ shows, disconnect the device from the
COMPACT/PC.
j. The device automatically powers down after a period of
inactivity or may be switched off by pressing the power
button on the left side of the device for 1 to 2 seconds.
k. Refer to site specic instructions for additional information
on clearing the device (‘No Subject (Blank e-Diary)’ option),
and what to do if a subject forgets their pin.
3. Operating Instructions
The Vitalograph 2120 In2itive e-Diary is a clinical trial device and
should be set up for a subject by a healthcareprofessional prior to
use. Any conguration required is completed prior to issuing the
device to the subject, as per Section 2. Set Up and Return.
The device is intended to be used for spirometry under the
supervision of healthcare professionals who are trained in
respiratory and lung function testing. The healthcareprofessional
provides information on the use of the device to the subject,
according to their site-specic instructions.
The device is only used at specied times of the day and will alarm
when it is time to complete a session. To complete a session the
subject follows the on-screen instructions.

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Figure 3: The device alarms when it is time to complete a session.
If the subject misses the alarm, they may turn on the device using
the On/Off power button on the side of the device and complete
the session so long as it is within the specied time window. If the
subject completes the session before the alarm but is still within
the specied time window, then the device will not alarm for that
time window.
Note: If a session is started and not completed, the data is not saved.
Note: If the device is used outside specied time windows, the data
will be displayed on the device, but it is not saved.
3.1. Main Menu
The Main Menu screen options are:
Figure 4: Main Menu Screen

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Begin Session: Follow the on-screen instructions
to complete a session, starting with the relevant
questionnaire and then the ow test.
Training: Includes information and videos on time
windows, and performing a blow including blow
faster, blow longer, do not cough, blow not consistent,
 accuracy,reproducibilityande󰀨ortquality.
Note: The demo option in the training option may be used at any time
but the data from that session will not be saved.
Note: If applicable, healthcare professionals are required to provide
training on completing a blow.
Settings: Includes volume control and audio feedback
options.
3.1.1. Subject Operating Instructions
1. Enter the PIN provided.
2. Select Begin Session from the Main Menu.
3. Follow on-screen instructions and complete
questionnaire(s).
4. Complete blows as per instructions in section 3.2.1.
5. Repeat steps 1-4 each time the device alarms for
each time window, for the duration of the study as
indicated by the healthcare professional.
6. Ensure all required sessions are completed every day.
7. Once the session is complete the device may be
switched off by pressing and holding the power
button on the left side of the device for 1 to 2
seconds. The device will auto power down after 5
minutes of inactivity.
3.1.2. Completing a blow
1. At the Test Screen perform the blow as instructed by
the healthcare professional at the clinic, following the
subject instructions given.

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Example script for performing a good blow:
a. Sit down in a chair.
b. Keep back straight.
c. Keep shoulders back.
d. Feet are at on the ground.
e. When the ‘blow now’ animated icon appears
on screen the device is ready for a test. Take a
deep breath, place the owhead into the mouth,
exhale out as hard and as fast as possible into the
owhead.
f. Keep blowing for at least 3 seconds.
Figure 5: Test Screen
The number of tests completed displays under the ‘Blow Now’ icon.
2. The result of each test displays on-screen with
quality information to inform the next test. Figure 6 is
an example of one possible screen. The test number
is displayed in the centre of the circles under the
blow now icon. To complete a session, 3 good quality,
consistent tests are required. If the tests are not of
good quality or are inconsistent, up to 5 tests may be
required to complete a session.

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Figure 6: Example Completed Test Screen
3. The results of the test session are displayed when
all blows for the session have been performed.
Figure 7 shows results screens for acceptable and
unacceptable quality test sessions:
Figure 7: Acceptable Vs Unacceptable Test Quality

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4. When results of the tests have been viewed, select
‘Continue’to indicate the test session is complete.
The device may be switched off by pressing and
holding the power button on the left side of the
device for 1 to 2 seconds. The device will auto power
down after 5 minutes of inactivity.
5. Data is automatically sent to Vitalograph study
servers once the session has completed.
 Figure 8: Test Session Complete
3.2. Calibration Verication
ISO 26782 recommendations require that the difference between
the volume measured by the spirometer and the volume pumped
into the spirometer from a syringe is within 3%.
1. The calibration verication routine is launched by
connecting the device to Spirotrac using the USB cable;
study specic calibration verication instructions may be
found in the site manual to meet study requirements.
2. Disconnect USB cable and wait for Device to enter
Calibration mode as per Figure 9.

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Figure 9: Calibration verication screen
1. Connect the device owhead to the syringe.
2. Enter details of the Manual 3L syringe, make a note of the
temperature. Press Continue.
3. Complete 3 strokes as per onscreen instructions. The volume
in (L) displays for each stroke.
4. If the reproducibility between the 3 consecutive syringe strokes
is less than 3% the calibration verication has passed, and a
tick displays on the syringe icon as per Figure 10.
Figure 10: Successful check with tick in syringe to indicate a pass.

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5. In the unlikely event the result is outside 3% the error icon will
show as per Figure 11. If the procedure was followed correctly
and the error icon is still shown the calibration verication may
be repeated. If this continues to show the user should contact
Vitalograph.
Figure 11: Error screen.
3.3. Cybersecurity Considerations
3.3.1. Specication
The device employs an Operating System (OS) that is not accessible
under normal use. Users can only access the device by entering
their pin via the on-device application. The device application runs
on top of the OS and is the only user interface to the device.
The OS has a congured rewall to protect against any
unauthorised access over the USB port, only Vitalograph PC based
applications can access the device over secure USB connection. No
further controls are required by users to secure the device.
The device will timeout and switch off after 5 minutes of inactivity.
If a user enters their PIN incorrectly 3 times, the device will not
allow any further attempts for 5 minutes.
The device uses an SD card for backup of stored data. The device
is shipped with an SD card inserted in the SD card slot and is

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protected with a tamper evident seal. If the device becomes
inoperable either by fault or compromise, the device should be
returned to Vitalograph where the data can be restored to the xed/
replacement device.
Note: The device should not be used if the tamper evident seal is
broken.
3.3.2. Security Recommendations
When connecting to a PC it is recommended that the PC has the
following cybersecurity in place:
• Operating System: ensure that the Operating System is
congured for automatic update for security patches
and has all of the latest patches applied.
• Antivirus/antimalware: ensure that the PC has a
reputable antivirus or antimalware application installed
and that all virus denitions are in place.
• Secure Login: ensure that the PC is password
protected via industry standard user access controls
via active directory or other methods.
• Firewall: if the PC is connected to the internet ensure a
reputable rewall or equivalent protection is in place to
protect against unauthorised external access.
3.3.3. Interfaces
USB: The device will only communicate with Vitalograph PC based
applications for the following functions (as described in Section 3
above):
• Device Conguration
• Device Software Update
• Download of Spirometry Test Data
SD Card: Only used for encrypted backup of stored data.
4. Power Management
The device can be powered from the COMPACT/PC via a USB cable
(at study site only), via a power supply or from the internal battery.
The battery power icon in the status bar at the top of the screen
shows the power status of the device.

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When powered from a power supply or USB, the plug icon displays
on the status bar, next to thebattery icon. 
Thedevice emits an alarm which turns on the device when it is
time to complete a session. If the subject misses the alarm, they
may still turn on the device using the On/Off powerbutton on the
side of the device. Once the session is complete the device may be
switched off by pressing and holding the power button on the left
side of the device for 1 to 2 seconds. The device will auto power
down after 5 minutes of inactivity.
4.1. Battery Pack
The device is tted with a rechargeable Battery Pack. This allows
the device to be used without the 5V Power Supply connected. The
battery pack may be recharged by plugging in the 5V Power Supply
to the mini USB connector on the leftside of the device. A full
charge takes 5 hours.
Note: The device will operate on a fully charged battery for 3 days. It
is recommended that the device is only charged once every 3 days,
when the battery low symbol displays. The internal battery needs to
be changed every 3 years. 
Note: When charging the device using the 5V Power Supply, ensure
it is plugged into an accessible socket so that it may be easily
disconnected from the mains supply if required. 
The battery pack may also be recharged by connecting the device to
a USB port on a COMPACT or PC via the USB cable connected to the
mini USB located on the left side of the device.
A plug icon next to the battery power indicator on the status
bar indicates when the device is charging. See battery power
indications at Section 4.2. The device may be used while charging.
A full charge takes 5 hours. If the battery is at less than 5% capacity
the device will power down. When not in use the device will auto
power down.
Note: A high power USB port capable of supplying 500mA is required
for charging over USB.

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4.2. Battery Power Indications
Battery is fully charged: a white ‘Battery Full’ icon
displayson the status bar at the top of the screen.
Disconnect the device from an external power
source when it is fully charged.
Battery is at less than 20% capacity: an orange
‘Battery Low’ icon displays on the status bar at the
top of the screen.
The device may be used but it is advised to
connect to an external power source to continue
testing.
Battery is almost discharged: the red ‘Battery
Discharged’ icon displayson the status bar at
the top of the screen. If battery is at less than 5%
capacity the device will power down.
Connect to an external power source to recharge
the battery before use.
4.3. Power Save Mode
When left unusedthe device will automatically power down after 5
minutes. This will occur whether the power is plugged in or not.
Pressing the On/Off button will turn the deviceback on.
5. Cleaning & Hygiene
5.1. Preventing Cross-Contamination of Subjects
There are no special temperature requirements for cleaning,
which may be carried out at room temperature. Theoutside
surfaces of the device may be cleaned with a 70% isopropyl
alcohol impregnated cloth to remove any visible soiling and for
low level disinfection. The outer surfaces should be cleaned
thoroughly (exteriorcase, owhead) with special attention to the
mouthpiece.The screen may be cleaned with a soft cloth or cotton
pad if required. After cleaning, the device should be inspected for
residual soil and repeat cleaning carried out if residual soil is visible.
For clinic use, or if a device is used by more than one test subject,
e.g. for training or demonstration purposes, a new Bacterial Viral

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Filter (BVF) should be used for every test. Using a BVF provides a
signicant level of protection for the subject, the device and the
user against cross contamination during spirometry manoeuvres.
The Vitalograph 2120 In2itive e-Diary is not designated as a sterile
device. It is a non-critical, single patient use device.
One cleaning cycle of the case/owhead should be performed
weekly.
Table ofCleaning/Disinfection Methods
Part Clean/
Low Level
Disinfection
Recommended Cleaning/Low Level
Disinfection
Case
exterior
Clean Wiping with a 70% isopropyl
alcohol impregnated cloth provides
a suitable form of cleaning.
The exposure time for low level
disinfection using 70% IPA wipes is
at least 1 minute.1
Screen Clean For the screen, lightly wipe the
surface with cotton pad or other
soft material.NOTE: DO NOT use
any chemicals. DO NOT wipe in a
circular motion. Strokes should be
either up/down or over/back.
5.2. Inspection of the Vitalograph 2120 In2itive e-Diary
No inspection of the device is required by the subject as it is a
clinical trial device, used under the supervision of a healthcare
professional.
It is recommended that the clinical trial assessor/healthcare professional
carry out a visual inspection on a routine basis. Examine mouthpiece
and ow conditioning mesh lter for damage or contamination. If they
are damaged or blocked, return the device for replacement with new
parts. Examine the Fleisch element and if damaged, return the device.
1 Rutala, W. A. 2017 “Back to the Basics” accessed from disinfection&sterilization.
org, June 2020.

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6. Fault Finding Guide
Problem Fault
Symptoms:
• False readings suspected
Possible
Solution: (In
probable order)
• Flowhead blocked or electronics
failure –contact support*/study site
administrator.
Problem Fault
Symptoms:
• Battery red icon displayed, device powers
down immediately.
Possible
Solution: (In
probable order)
• The battery requires charging.
• Battery faulty –contact support*/study
site administrator.
Problem Fault
Symptoms:
• Will not connect to Spirotrac.
Possible
Solution: (In
probable order)
• Check USB cable connection betweenthe
device and the COMPACT/PC.
• Ensure instructions in Section 2 have been
followed. The PIN should not be entered on
the device at this stage.
• Electronics failure – contact support*.
Problem Fault
Symptoms:
• Cannot read screen.
Possible
Solution: (In
probable order)
• The battery may be low. Plug in the power
cable and switch on the device.
• Screen failure –contact support*/study
site administrator.
• Electronics failure –contact support*/
study site administrator.
Problem Fault
Symptoms:
• Cannot log into device
Possible
Solution: (In
probable order)
• Forgotten/incorrect PIN - contact site
administrator.
• Screen failure –contact support*/study
site administrator.
• Touch panel failure –contact support*/
study site administrator.