Vitalograph In2itive e-Diary User manual

In2itive e-Diary
Instructions for Use
MODEL 2120
© Copyright Vitalograph 2020 Current Edition (Issue 1, 24-Feb-2020) Cat. No. 09140

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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 1, 24-Feb-2020)
Cat. No. 09140
Vitalograph is a registered trademark.
Vitalograph Branch Addresses

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Contents
1. Main Components ................................................................4
1.1. Features.................................................................5
2. Set Up ...................................................................................5
2.1. Device Set Up ........................................................6
2.2. Spirotrac Set Up....................................................6
3. Operating Instructions..........................................................6
3.1. Subject Use ..........................................................7
4. Power Management .............................................................8
4.1. Automatic Power Down........................................9
4.2. Battery Pack..........................................................9
4.3. Battery Low Detect ...............................................9
5. Cleaning & Hygiene...............................................................9
5.1. Hygiene and Cleaning...........................................9
5.2. Inspection of the In2itive....................................10
6. Fault Finding Guide.............................................................11
6.1. Software Check...................................................12
7. Customer Service................................................................12
8. Consumables and Accessories .........................................12
9. Disposal...............................................................................12
10. Explanation of Symbols......................................................13
11. Description of the Vitalograph In2itive e-Diary..................14
11.1. Use in Clinical Trials............................................14
11.2. Indications for Use..............................................15
12. Technical Specication ......................................................15
13. Contraindications, Warnings, Precautions and
Adverse Reactions..............................................................17
14. CE Notice.............................................................................20
15. FDA Notice ..........................................................................23
16. EU Declaration of Conformity.............................................24
17. Guarantee ............................................................................25

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1. Main Components
Figure 1: Main Components of the Vitalograph In2itive e-Diary
Note: Computer not supplied
1 COMPACT Expert or PC running Spirotrac software
2 Flowhead
3 Flowhead Release Button
4 LCD/Touch Panel Display
5 Mini USB Ports
6 Power Button (On/Off)
7 Stylus Holder
8 Cancel Button
1
2
3
4
5
6
7
8
910
11
12
13
14
15

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9 Enter Button
10 Up Button
11 Down Button
12 Reusable mouthpiece
13 Stylus
14 Charging Cradle
15 LED Charging Light
1.1. Features
The features include:
• Congurable.
• Stores questionnaire results and spirometry tests.
• Touch screen colour display.
• Portable.
• Connectivity via GPRS (2G and 3G)
• Fleisch type pneumotachograph owhead to measure
ow.
2. Set Up
The Vitalograph In2itive e-Diary is a clinical trial device and is set
up by a healthcare professional for a particular subject prior to
use. Any conguration required is downloaded to the device prior
to issuing the device to the subject; this includes the appropriate
questionnaire, number of sessions per day, time windows and
automatic power down time. The subject receives study specic
device training from the site then takes the device home with them.
Customised study manuals are provided to each site that include
specic detail on device set up and use dependent on the study
requirements.

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Device:
2.1. Device Set Up
Unpack and fully charge the Vitalograph In2itive e-Diary prior to
conguration, using either the power supply issued with the device
(either via the cradle or plugged into the device directly) or via USB
connected to the study PC or COMPACT Expert Workstation. The
cradle is powered using the power supply issued with the device
so that the device can charge via the cradle or the issued power
supply may be used directly with the device. A full charge takes
approximately 5 hours.
Note: Only use the Vitalograph In2itive e-Diary with the purpose-built
low voltage power supply unit with which it is supplied. Attempted
use with other power sources may cause irreparable damage and
invalidate the warranty.
Note: A USB port capable of supplying 500mA is required for
charging over USB.
Note: If the device has just been unpacked or transported, ensure
that it is left sitting, fully powered in order to reach room temperature
prior to testing.
2.2. Spirotrac Set Up
Create subject information on Spirotrac prior to setting up the
device. Spirotrac set up includes language selection, assignment
of subject PIN codes and other study specic requirements for the
device.
For full instructions and guidance on using the Vitalograph In2itive
e-Diary with Spirotrac please refer to the customised study manual.
3. Operating Instructions
Prior to use, the Vitalograph In2itive e-Diary should be set up and
congured for subject use following instructions in the study
manual.
The Vitalograph In2itive e-Diary is intended to be used for

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spirometry under the supervision of healthcare professionals who
are trained in respiratory and lung function testing. For clinical
trial use the measurable parameters are usually restricted to
FEV1 and PEF. The device also collects e-PRO diary scores. The
healthcareprofessional will provide information on the use of the
device to the subject, according to site-specic instructions.
The Vitalograph In2itive e-Diary is intended to be a single patient
use device. If, for any reason, a device is used on more than one
subject (E.g. for training demonstrations) it is intended that a new
single use bacterial viral lter is used per subject to protect both the
device and the subject from cross contamination.
Note: Healthcare professionals are required to provide subject
training on completing a blow.
3.1. Subject Use
During subject use, the Vitalograph In2itive e-Diary should always
be left charging in the cradle when not in use. The cradle must be
powered using the power supply issued with the device. Ensure the
device is sitting rmly in the cradle, otherwise it will not charge. An
ORANGE light on the cradle signies the device is charging.
• The subject can check if the Vitalograph In2itive e-Diary
is charging by powering it on. Charging is indicated by
moving bars in the battery symbol at the bottom of the
device.
• A full charge will last for up to four days.
• If the device is not charged, there is a risk that it will not
alarm and there will be insucient power to record home
results.
• If the battery is low, the device displays a ashing red
battery icon.
The Vitalograph In2itive e-Diary is intended to be used at specied
times of the day and will emit an audible alarm and provide on-
screen instructions at each time that is pre-set for a subject to
complete a session.
If the subject misses the alarm, they may turn on the device using
the power button and complete the session so long as it is within

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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.
The site is responsible for instructing and supervising subject
use of the device to meet the requirements of the study. Detail of
required training for the subject and subject instruction cards are
included with site instructions.
Notes:
• If a session is started and not completed, the data is not
saved.
• If the device is used outside specied time windows, the
data displays on the device but is not saved.
• Ensure that the Vitalograph In2itive e-Diary does not get
wet or it may cease to operate.
• If a subject forgets their In2itive e-Diary PIN code they
should contact the site immediately.
4. Power Management
The Vitalograph In2itive e-Diary may be powered using the power
supply with which it is issued, from a PC via the USB cable, or from
the internal Battery Pack. When the issued power supply is plugged
into the cradle, the device may be powered by docking it in the
cradle. When powered from the issued power supply or a PC, the
LED on the front of the device shows orange. The LED shows green
when the device is powered from the Battery Pack.
Note: A USB port capable of supplying 500mA is required for
charging over USB.
TheIn2itive e-Diary emits an audible alarm when it is time to
complete a session and the device turns on. If the subject misses
the alarm, the device will automatically power down after a period
of time, but the device may be turned on again by pressing the
powerbutton. Once a session is complete, the device may be
switched off by pressing and holding the power button, or will auto
power down after a period of inactivity.

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4.1. Automatic Power Down
The automatic power down function in the Vitalograph In2itive
e-Diary is congured to a specied time, up to a maximum of 30
minutes and cannot be changed by the site. This information is
downloaded to the device at device set up.
4.2. Battery Pack
The Vitalograph In2itive e-Diary is tted with a rechargeable Battery
Pack. This allows the device to be used without the 5V power
supply connected. The battery pack can be re-charged using the
issued 5V power supply either directly or via the cradle. To fully re-
charge switch off the device and leave it plugged in overnight.
The battery pack can also be re-charged by connecting the device to
a PC via the USB cable.
4.3. Battery Low Detect
Battery Low: The icon ashes on and off on the
Main Menu screen.
The Battery Pack is running low. You may
continue to use the device.
As a precaution, plug in the 5V Power Supply
or USB cable to a PC or Vitalograph Compact
USB port to re-charge the batteries and continue
testing
Battery Discharged: The icon appears continuously
on the Main Menu screen.
The Battery Pack is out of power. If you press any
key a warning message appears and you will not
be allowed to proceed further.
Plug in the 5V Power Supply or USB cable to PC
or Vitalograph Compact USB port to re-charge the
batteries and continue testing..
5. Cleaning & Hygiene
5.1. Hygiene and Cleaning
The Vitalograph In2itive e-Diary is a single patient use device. At the

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end of the study, devices must be returned to the manufacturer as
per Section 9 Disposal.
The outside surfaces of the device and owhead may be cleaned
with a 70% isopropyl alcohol (IPA) impregnated cloth to remove
any visible soiling and for low level disinfection. The screen may be
cleaned with a soft cloth or cotton pad if required. The Vitalograph
In2itive e-Diary is not designated as a sterile device.
Note: Do not use any chemicals apart from the 70% IPA
impregnated cloth specied. Wipe either up/down or over/back. Do
not wipe in a circular motion.
5.2. Inspection of the In2itive
The Vitalograph In2itive e-Diary, Model 2120 is a clinical trial
device, used under the supervision of a healthcare professional. No
inspection of the device is required by the subject.
For the clinical trial assessor/healthcare professional a visual
inspection of the device is recommended on a routine basis.
Examine the owhead body containing the Fleisch element and
owhead cone containing the ow conditioning mesh lter for
damage or contamination. If they are damaged or blocked, return
the device to Vitalograph for replacement with new parts. Re-
assemble the owhead cone and owhead body after inspection.
Figure 2: Flowhead Assembly
1 Flowhead Body
2 Flowhead Release Button
3 Flowhead Cone

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6. Fault Finding Guide
Problem Fault
Symptoms:
• Test begins automatically
• Volume accumulates automatically
without the subject blowing.
Possible Solutions:
(In probable order)
• Flowhead not stationary at start of test.
Hold device steady until the ‘Blow Icon’
appears.
• Return to Main Menu and re-enter the
test routine.
Problem Fault
Symptoms:
• Rocking cradle
Possible Solutions:
(In probable order)
• Check for damaged or missing rubber
feet.
• If any rubber feet are damaged or
missing replace all rubber feet. Contact
support.
Problem Fault
Symptoms:
• Cannot communicate with Spirotrac/
Vitalograph Web portal
• Corrupt or missing data
Possible Solutions:
(In probable order)
• Check USB cable is connected between
device and the PC/Compact.
• Check Spirotrac Application is correctly
installed.
• Check the required software drivers are
installed on the PC.
• Electronics failure – contact support.
Problem Fault
Symptoms:
• Cannot read screen.
Possible Solutions:
(In probable order)
• The battery may be low. Charge the
device.
• LCD failure – contact support.
• Electronics failure – contact support.

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6.1. Software Check
At power on, the main screen shows the study name, study number
and subject ID. The device serial number may be found on the rear
of the device. Please quote this information to Vitalograph support
when requesting further advice or assistance so that the relevant
software version may be identied.
7. Customer Service
The Vitalograph In2itive e-Diary has no serviceable parts. The device
must be returned to the manufacturer, Vitalograph, at the end of
the Study. Repairs should only be carried out by the manufacturer.
The site should contact the manufacturer for assistance in setting
up, using or maintaining the equipment, changes in performance
or to report unexpected operation or events. Contact information
for the site administrator is available in the site manual. Contact
information for the manufacturer is available at the start of this
manual.
Any serious incident that has occurred in relation to the device
should be reported to Vitalograph and the competent authority of
the state. Refer to the Vitalograph contact information at the start
of this manual.
8. Consumables and Accessories
Cat. No Description
28553 Eco BVF with Bite Lip and Disposable Nose Clip (75)
40079 Mini USB Cable
79159 5V DC PowerSAFE
79165 Test Data Storage Card
79166 Stylus (2)
9. Disposal
The Vitalograph In2itive e-Diary is a clinical trial device and must be
returned to the manufacturer at the end of the study.
Used BVFs constitute minimally soiled waste from human

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healthcare and should be disposed of in line with local
requirements. BVFs are made from polypropylene.
10. Explanation of Symbols
Symbol Description
Type BF equipment
Class II
VA Power rating
Direct current
Instructions for Use; operating instructions
Manufacturer
Date of Manufacture (include date in format yyyy-
mm-dd)
USB connector
The device must be taken to separate collection
at the product end-of-life. Do not dispose of these
products as unsorted municipal waste
Fragile, handle with care
Keep Dry
Storage Temperature Limit
Storage Relative Humidity Limits
Do not re-use

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Non sterile
Recycle
QR code - matrix bar code. All information in the bar
code is included in the text under it
Device Order Number
Lot/Batch Number
Serial Number
Power Button (On/Off)
11. Description of the Vitalograph In2itive e-Diary
The Vitalograph In2itive e-Diary is a handheld spirometer which
measures subject respiratory parameters including but not limited
to VC, FVC, FEV1, PEF and MVV. The integral Fleisch owhead is
used for testing.
11.1. Use in Clinical Trials
Within clinical trials the primary use of the Vitalograph In2itive
e-Diary is home measurement of specied respiratory parameters
and monitoring of e-PRO using an integrated diary function.
It is designed for use by trained professionals in a variety of
environments for recording data, capture of patient reported
outcomes, measuring and archiving tests on human subjects.
The device can measure a range of respiratory parameters but
is typically restricted to measuring PEF and FEV1 to meet the
requirements of clinical trials. Answers to relevant questionnaire(s)
are entered via an on-screen keypad and stored, together with
test data. Current test data can be viewed on the screen and
downloaded and printed through the Spirotrac application. There
are a variety of conguration options available.

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11.2. Indications for Use
The indications for use of the Vitalograph In2itive e-Diary is in the
assessment of lung function through the measurement of dynamic
lung volumes, i.e. spirometry.
The Vitalograph In2itive e-Diary is designed to be operated by
medical professionals trained in respiratory and lung function
testing on adults and paediatrics, 2.5 years and older, in a variety
of professional healthcare environments, e.g. primary care,
hospitals and occupational health centres. In a clinical setting,
the measurements obtained from a lung function test form part
of the various ndings of a physician in the detection, diagnosis
and control of chest diseases. Spirometry may support or exclude
diagnosis, but it cannot make one.
Apart from this instruction manual, there are no other training
requirements for the medical professional.
12. Technical Specication
Product Vitalograph In2itive e-Diary, Model
2120
Flow Detection Principal Fleisch type pneumotachograph
Volume detection Flow integration sampling at 100Hz
Maximum test duration 90 seconds
Maximum displayed
volume
10 L
Volume Accuracy Better than ±3% or ±0.05L of the
reading. (ISO 26782:2009)
Flow Measurement
Range
Max. ow rate ±960 L/min (±16 L/s)
Min. ow rate ±1.2 L/min (±20 L/s)
PEF Accuracy ±10% or ±10L/min of the reading
(ISO 23747:2009)
Back pressure Less than 0.1kPa/L/sec at 14L/sec
(ATS/ERS 2005)

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Operating temperature
range
ISO 26782 limits: 17–35ºC; Design
limits: 10–40ºC
Operating humidity
range
30%–75%
Ambient pressure range 850hPa–1060hPa
Performance standards
the Vitalograph In2itive
e-Diary meets or exceeds
ATS/ERS 2005, ISO 23747:2009 &
ISO 26782:2009
Safety standards EN60601-1: 2006
EMC Standards EN 60601-1-2: 2007
QA/GMP standards EN ISO 13485, FDA 21 CFR 820,
EN ISO 23747:2009, EN ISO
26782:2009
Dimensions 160 mm x 100 mm x 45 mm
Weight 0.23 kg net
Storage Temperature 0–50°C
Storage Relative
Humidity
10%–95%
Communications USB, micro SD card
Power Supply 5V DC power, 5V USB 2.0/3.0 or
3.7V Lithium-ion battery
Essential Performance Flow measurement output
Essential Performance
Test Limits
Flow Accuracy ±10% or ±20 L/min
(ATS/ERS 2005)

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Minimum PC System
Requirements for Spirotrac
or Vitalograph Reports
software
Processor Speed: 2GHz or greater
RAM: 2GB (Min), 4GB
(Recommended)
Disk Space: 1GB or greater
Operating System: Windows 7 or
above
Monitor: 1280 x 800 pixel
Other: .Net framework 4.5.1, USB
Port for device.
Notes:
• All ow and volume measurement values
displayed are expressed as BTPS values.
• Time zero is determined using the back-
extrapolated method, from the steepest
part of the curve. The operating and storage
conditions specied apply to the device plus
accessories.
• The Vitalograph In2itive e-Diary and BVF
(where used) are classied as type BF
applied parts. Other accessories are not
applied parts
• An applied part is a part of the equipment,
which in normal use necessarily comes
into physical contact with the subject for
equipment or system to perform its function.
13. Contraindications, Warnings, Precautions and
Adverse Reactions
1. No modication of this equipment is allowed. Any
unauthorised changes to the device may compromise product
safety and/or data and as such Vitalograph cannot be held
responsible and the device will no longer be supported.
2. The Vitalograph In2itive e-Diary has no serviceable parts. The

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device must be returned to the manufacturer at the end of the
Study.
3. Repairs should only be carried out by the manufacturer.
4. The Vitalograph In2itive e-Diary should only be charged with
the medically approved 5V power supply that is supplied with
the device or via a PC/Compact USB port using the supplied
USB cable.
5. The Vitalograph In2itive e-Diary is not designed as a sterile
device.
6. Always follow the safety guidelines given by the manufacturer
of cleaning and disinfectant chemicals.
7. Spirometry is a valuable tool that provides important
information to clinicians which is used together with other
physical ndings, symptoms, and history to reach a diagnosis
(ATS/ERS 2019). As such, spirometry may support or exclude a
diagnosis but it cannot make one.
8. Take care not to block the mouthpiece with tongue or teeth
during testing. A ‘spitting’ action or cough will give false
readings.
9. Subject fatigue may occur during spirometry testing depending
on the subject’s characteristics e.g. age, health status. To
avoid this, the subject may sit during the testing or take a
break between tests. The maximum number of registered tests
allowed on a Vitalograph In2itive e-Diary per session is 5.
10. Maintenance must not be performed while the device is in use
by a patient.
11. Do not disconnect the USB cable from the Vitalograph In2itive
e-Diary or COMPACT/PC running Spirotrac during data transfer.
12. On rst conguration of each Vitalograph In2itive e-Diary, it will
be updated with the latest rmware, which may take several
minutes. The device must not be disconnected during update;
doing so may permanently damage the device.
13. If the subject is issued with an e-Diary congured with the
wrong subject number this can cause baselines for both
subjects to be incorrect for the entire study.
14. If the subject forgets their PIN they should contact the site
administrator.
15. For charging via USB a high-power USB 2.0/3.0 capable of

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supplying 500mA must be used or it will not charge the device
fully or charging will take longer than 5 hours.
16. The Vitalograph In2itive e-Diary owhead is intended to be a
single patient use device. If, for any reason, a device is used on
more than one subject (e.g. for training demonstrations) it is
intended that a new single use bacterial viral lter is used per
subject to protect both the device and the subject from cross
contamination.
17. To isolate the Vitalograph In2itive e-Diary from the mains
power supply, remove the 5V Power Supply from the mains
wall socket. When charging the device via the 5V Power Supply
do not position the 5V Power Supply where it is dicult to
unplug from the socket.
18. The device contains a Lithium coin cell battery and a Lithium
ion main battery, neither of which are accessible by the user
and are not serviceable parts. Any suspected battery faults
should be reported to the manufacturer.
19. The internal Lithium ion battery is not user accessible,
replaceable or serviceable. In the unlikely event that any
issues are noted with the power or battery such as swelling or
leaking, stop using the device immediately, do not charge the
device and contact the site administrator or the manufacturers’
support. In case of leaking ensure the electrolyte does not get
in the eyes or touch skin as it may cause damage. If electrolyte
gets into the eyes ush the area immediately with water for 15
minutes and seek medical attention. If it gets on the skin wash
the affected area immediately and seek medical attention. Do
not inhale the leaked material, leave the area immediately and
allow the battery to cool and any material to dissipate.
20. Keep the device away from thermal ignition sources including
but not limited to, res, cookers and heaters. The ISO 26782
spirometry standard species a temperature of 17-37oC
for spirometry testing. The Vitalograph In2itive e-Diary also
contains a lithium ion battery and excessive heat may cause
damage or swelling.
21. The power supply supplied with the device has a long cable
which may be a strangulation hazard and therefore should be
kept out of the reach of children and pets.

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22. The device should not be used in the presence of ammable
liquids or gases, dust, sand or any other chemical substances.
23. Use of accessories and cables other than those specied
or provided by Vitalograph for this equipment could result
in increased electromagnetic emissions or decreased
electromagnetic immunity of the Vitalograph In2itive e-Diary
and result in improper operation.
24. 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 Vitalograph
In2itive e-Diary including cables specied by Vitalograph.
Otherwise, degradation of the performance of this equipment
could result.
25. 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.
26. The applied part is the owhead and the device body, these are
the contact points for the subject during a spirometry session.
There are no adverse effects from incidental contact with any
other part of the Vitalograph In2itive e-Diary.
27. For the device to be used as intended, there is no requirement
to clean the supporting computer. If cleaning is required to
remove any visible soiling, this should be done as per the
computer manufacturer’s instructions.
28. If the device has just been unpacked or transported, ensure
that it is left sitting, fully powered in order to reach room
temperature before testing.
14. CE Notice
Marking by the symbol indicates compliance of the Vitalograph
In2itive e-Diary Model 2120 to the Medical Devices Directive of the
European Community.
The Vitalograph In2itive e-Diary is intended for use in a variety of
professional healthcare environments, e.g. primary care, hospital
wards and occupational health centres, except for near active high