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 About this Manual

T his manual is designed to guide you step by step, through the

various aspects of Spriofy™ device. This manual will help, you
understand how to operate, clean and troubleshoot the possible
issues with Spriofy™. It is assumed that the user has a desktop,
laptop, smartphone or a tablet, as the test is directly dependent
on a web application (app) for data display, access, storage,
and printing.

Please note that the screenshots of the application shown in the

manual are intended only as examples and are liable to change
with periodic application updates.

In case of any doubt or queries, please email at hello@neebal.

com or refer to the ‘raise a query’ section in the application
 Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 2

3. Contraindications & Warnings . . . . . . . . . . . . . . . . 3

4. Instrument installation. . . . . . . . . . . . . . . . . . . . . . 6

5. Performing spirometry . . . . . . . . . . . . . . . . . . . . . 35

6. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 41

7. Definition of parameters . . . . . . . . . . . . . . . . . . . .

8. Maintenance of the instrument . . . . . . . . . . . . . . . . 42

9. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . 43

10. Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .

11. Regulatory certificates . . . . . . . . . . . . . . . . . . . . .

12. Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . .

13. Annexures . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction

Spirofy™ is a compact, rechargeable battery operated and portable

diagnostic spirometer. Its ergonomic and user-friendly design allows
the device to be used in a wide range of clinical settings. Spirofy™ is a
pneumotach-device spirometer, where a pneumotachometer converts
the flow of gases through it into a proportional signal of pressure
difference on either side of a central mesh whose design ensures a
signal linearity over a range of flow rates with a minimum dead space.

The features offered by Spirofy™ include-

• Measures forced expiratory volume in one second (FEV1), forced

vital capacity (FVC), FEV1/FVC, peak expiratory flow rate (PEFR),
forced expiratory flow at 25% to 75% of forced vital capacity (FEF25-
75)

• Provides post-bronchodilator comparison

The user can share, save and print the report.

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Intended Use

Spirofy™ is intended to measure the maximal volume and flow of air

that can move in and out of a patient’s lungs. This device is intended
for use in adult patients in hospitals, physician offices, laboratories or
occupational testing environments.

Spirometry is useful
• For the diagnosis of obstructive and restrictive lung diseases

• For risk assessment of patients undergoing cardiothoracic surgeries

• For patients undergoing non-cardiothoracic surgery and suspected

to have chronic obstructive pulmonary disease (COPD) and other
chronic lung diseases

• For prognostication in several conditions such as COPD, asthma,

bronchiectasis, interstitial lung disease (ILD), and neuromuscular
diseases

• To monitor disease progression in ILD, COPD, asthma and

bronchiectasis

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Contraindications & Warnings

Contraindications for spirometry

• Unstable cardiovascular status such as myocardial infarction within
previous 1 month
• Recent thoracic or abdominal surgery (within previous 6 weeks)
• Recent eye or ear surgery (within previous 6 weeks)
• Proven or suspected active pulmonary tuberculosis
• Thoracic, abdominal, or cerebral aneurysm
• Oral or facial pain exacerbated by mouthpiece
• Active hemoptysis
• Uncontrolled blood pressure
• Acute illnesses that may interfere with performance of the procedure
such as acute respiratory tract infection, nausea, vomiting, chest
pain, or abdominal pain
• Last trimester of pregnancy

In presence of any of the mentioned condition/s, it is better to wait till

the patient fully recovers before subjecting the patient to spirometry.

Warnings and Cautions

The following terms are used as follows in this manual

Caution: Suggestion of steps/ action to be taken to avoid mistakes,

injury or serious damage

Warning: Statement/s that indicate conditions or practices that could

result in injury or damage. Knowledge of these can help avoid future
danger.

Please Note: Important information for avoiding damage to the

instrument or facilitating operation of the instrument.

Note: The device should only be used by trained and qualified personnel.

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Warning: The instrument is not suitable for use in the presence of explosive
or flammable gases, flammable anesthetic mixtures or in oxygen rich
environments.

Warning: Use of portable phones or other radio frequency (RF) emitting

equipment near the system may cause unexpected or adverse
operation

Caution : Airways are for single patient use.

Caution : Do not allow the patient to handle the spirometer when

connected to either the power supply for charging or to a PC when
configuring the unit

Warning: The user must not touch any voltage-carrying parts and the
patient at the same time

Please Note: The product should not be disposed of as unsorted waste.

Please utilize your local recycling facility for the disposal of this product.

Precautions
• It is highly recommended that you read the entire manual and watch
the tutorial videos entirely before attempting to take a test.

• Do not keep the spirometerSpirofy in a damp place or expose it

to extreme temperatures. Avoid exposing the Spirofy™ to direct
sunlight.

• Avoid operating the spirometer in dusty conditions or near heating

appliances or radiators.

• Do not keep the spirometer in a damp place or expose it to extreme

temperatures.

• Reusing airways incurs a risk of transmitting diseases from one person

to other via saliva. Ensure a fresh airway tube for every test.

• Only use Spirofy™ certified airway tubes that are approved by Cipla.
Using counterfeit tubes will yield incorrect results and may lead to
misdiagnosis.

• Keep the Spirofy™ system with all its components away from children
aged 3 years or below. There is a risk of suffocation if small parts like
mouthpiece or an airway component gets swallowed accidentally.

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• Do not exert excessive physical pressure while assembling/
disassembling the airways tubes, attaching the airwaystube to the
Spirofy™ device and while docking the system for a charge; as it
may damage sensitive hardware components like filter points,
attachment points and charging pins.

• Wipe clean the device regularly with a dry paper towel.

• Refrain from using Spirofy™ in airplanes or moving vehicles, unless

necessary.

• Do not make any modifications to any part of the hardware or open

the device as it would void the warranty.

• Use only the charging adapter and charging cable provided in with
the device for charging.

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Instrument Installation

Hardware overview
A retail unit of the Spriofy™ contains relevant paperwork and the
following items:

Airway tubes (x9)

Spirofy™ device (x1) Charging dock (x1)

Charging cable and Adapter (x1) Top slide cover (x1)

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a. Airway tube
The airway tube would be the primary contact point for a patient
while taking a test. The tube consists of a mouthpiece for the patient
to exhale into and a pair of contact points for the filters to attach to
the Spirofy™ device.

Attachment points

Attachment points are to affix the airway on to the device. Please

ensure proper fitment of airway to the device before taking a test*.
* If the fitment is improper, readings can be affected. Contact customer care immediately
in case of queries

b. Spirofy™ device:
The Spirofy™ device will hold the airways while taking a test. It also
houses critical electronics and sensors that make the Spirofy™ as
accurate as it is. Due to this reason, avoid dropping the device or
subjecting it to any sort of external impacts as it may damage the
internal components and cause improper functioning. Also, do not
damage/bend the charging points of the device.

Power button
to switch on
the device
and connect
to the
application
3
2
4
1
5
Blue LED light Attachment points for the
indicating airway#
connection
to a mobile
phone

1
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c. Charging dock

1. Lock for the Spirofy™ device to affix.

2. Charging grooves for the corresponding pins on the Spirofy™ device.
(Please avoid exerting excessive force or attaching the
device incorrectly as it may damage the pins.)
3. Port for inserting the USB cable while charging the device

The charging dock has been designed to charge the Spirofy™

device quickly and safely, as well as to provide the device a secure
place to sit while not in use. The dock has a light at the bottom to
indicate if it has electrical supply from the adapter and is ready to
charge the device.

d. Top slide cover

The top slide cover is intended to be used while taking a test. It

attaches over the airway and secures it with the device with locks
denoted by numbers 1 to 4 in the above image. They ensure proper
fitment and makes sure the airway does not slide or detaches itself
while taking a test.

The slide cover is made from soft plastic. Do not subject the cover to
excessive external impact or bending as it may damage the cover.

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e. Charging cable and Adapter:

USB-C

mini USB

A standard USB-C (Broad end) to mini USB (Narrow end) cable is

provided in the box to charge the device. The mini USB end is to be
inserted in the charging dock and the USB-C end is to be attached to
the provided charging adapter only. Only use charging cable and
adapter provided with the device.

Installation of app
The first step in installation of device is to install the app on your mobile .

Downloading the Spriofy Application

• The Spirofy™ system has been designed to work in tandem with the
Cipla Spirofy™ application.
• The app is available on the Apple App Store, Google Play Store and
Spirofy Windows Portal. It requires Android version 4.4.4 or above, iOS
8 or above and Windows 7 or above.

Steps for downloading (For Android users)

• Open Google Play Store

• Search for Cipla Spirofy™ (Put Cipla Spirofy™ in the search bar at the
top)
• Click on Cipla Spirofy™ in the search, and then click on the install
button
• The app may take some time to download and install depending on
the internet and processor speed.

Steps for downloading (For iOS users)

• Go to Apple App Store

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• Search for Cipla Spirofy™ (click on the magnifying glass on the
bottom right of the app, and then type Cipla Spirofy™)
• Click on Cipla Spirofy™ and then click on ‘GET’

• The app will start downloading.

• The app may take some time to download and install depending on
the internet and processor speed.

Registering on the app

When using the device for the first time follow below mentioned steps
for Android/ iOS. Refer section 4.11 for steps to connect with Spirofy
Windows Application.
Creating an account/Logging in

First time users should click on “Register Here”.

Fill in the details, such as your name, email address,

& set and confirm password.

Read and click the “I agree with Privacy Policy”

check box; and click on “Register”.

Then Email verification screen will appear. Check

your entered email for OTP. If not in main Inbox
then check for the email in the Spam folder. If OTP
doesn’t arrive, check your internet connection
and click “Resend OTP”.

Next, Enter the OTP in the field and click “Confirm”.

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To log in with an existing account, enter the registered email address
and password.

Connecting the Spirofy™ Device to the app:

Switch ON Once done,
Spirofy™ click on
device along “Refresh”
with Bluetooth button.
and location
services of the
phone/tablet.

If multiple Click on
Spirofy™ the device
devices are name (Spirofy
switched followed by
ON, and not a number
connected depending on
to another active devices
phone, all of nearby) and
them would press “Confirm”
be displayed to add the
on the screen. device.
Hence, only
switch ON the
device that
you want to
connect.

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Device home screen
App home screen displays the following from the top to the bottom:

Device options menu

Button to rename the device Connection status and device

battery percentage

Calibration timeline Patient case code options

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Options menu
Options menu can be accessed by clicking on the top right button in
the device home screen. It contains the following options:

Charging the device

It is recommended to fully charge your device before the first use

• Remove the accompanied charging dock along with the USB cable
and adapter provided in the box.

• To connect the charging cable to the dock, attach the larger end of
the cable to the adapter and the smaller end to the charging dock.

• Remove the Spirofy™ device from the box.

• Note that the Spirofy™ device has two vertical edges, one thinner
than the other. Locate the contact points on the thinner edge of the
device.

• Align the thinner edge of the Spirofy™ device with the docking slope
such that the contact points slide in to attach with the charging pins.

• Slide the Spirofy™ device completely in the dock such that it fits in
flush with the dock (Images depicting the correct way)

Correct placement

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CAUTION: Ensure that only the contact points and not the plastic
edge meets the charging pins as this could damage the pins. (Images
depicting the incorrect way)

Incorrect placement

• To ensure the lock, check for the latch on the dock and the
corresponding cavity on the Spirofy™ device.

• Once the device is successfully attached, switch on the power

supply and check for a light on the bottom right corner of the dock.
This indicates that the device is being charged. It will glow Green if it
is fully charged or Red if it is being charged.

• It takes approximately 60 minutes for the device to get fully charged;

It is recommended that you charge the device after it reached 30%
battery.

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CAUTION
Do not touch the charging pins on the dock as it may damage them.
Avoid using unapproved cables for charging as they may damage
the port.

Assembling the device

Attaching the airway to the device

1. To take a test, you need to attach the airway tube to the Spirofy™
device.

2. To do so, firstly remove the Spirofy™ device from the charging dock.

Do not attach the airway to the device and/or attempt taking a test
while it is being charged.

3. Take a fresh, sterile airway tube and locate the attachment points at
the device of the airway.

Always use a new and sterile airway tube for a new person. Do not
reuse tubes.

4. Carefully align the attachment points on the tube with the

corresponding points on the device. Apply gentle force to affix the
two elements securely into one another.

Do not apply excessive force while attaching as it may damage the

Spirofy™ device.

5. Once both the elements are attached together, affix them firmly by
attaching the slide cover on top of them. This prevents the airway
tube from accidentally detaching itself while taking a test.

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Connecting the device to the app

Now all that’s left is to connect the device to the application. Refer to
section 4.2.3.

Adding a case
To generate a new case code, click
on the “+” add button. Patient ID is
automatically generated.

Enter patient details and phone

number in the provided fields. Click
on “Save” to proceed.

Enter OTP received on patient phone

and click on “Confirm” to create a
case code.

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If OTP is not received for 30 seconds,
digital signature option will be
available. Click on the “Sign here”
window and have the patient sign
on the screen.

Click on the two check boxes and

press “Confirm” to create the case
code.

You can read the full privacy policy by clicking on the highlighted
“Privacy Policy” text in point 2.

Taking a test
To take a test on Spirofy™ device, click on the case code number.
Patient details page will contain the case code and option to select Pre
and Post-test options. Click on Pre and click “Take A Test”.

Ensure that you are using an unused airway for the patient. Click on
“Yes, I have”.

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• Device would do a quick self-calibration. During this process, Ensure
zero flow through the device during this step.

• Spirometry can be performed once you see the “Ready for Test”
screen. Ensure to do the test in a quiet room with no air current as
much possible. Instruct and ensure that the patient does not breathe
into device.

• Have the patient perform Spirometry. Click on “Retry” to take multiple

tests. Click on “Cancel” to cancel the attempts and not save any
data.

• Select a minimum of three attempts by clicking on the green check

box on the top right corner of the screen.

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• You can toggle within the tests taken by
clicking on test number tabs on the top. Click
on “Proceed” to save the effort.

• Select any symptoms and their intensity,

if observed in the patient. Add additional
observations if any in the text box.

• Finally click on “Save” button and go to the

result screen for report generation.

• Click on “Cancel” button to cancel the effort.

Report generation, sharing and

printing.
• Test summary would appear below the “Take
a Test” button in the ‘Patient details’ page.

• Date and time of the test along with type (Pre

or Post) will be displayed in the summary.

• Test graph and values would be displayed

below, along with test grade and symptoms
observed.

• Click on “View Report” to see full size A4

format report. Click on “Print Report” to view
thermal printer printable report.

• Both reports are in PDF format and can be

viewed in any PDF reader. Drive PDF Viewer
is recommended for android devices. Reports
can be shared as PDF via compatible
applications on your phone

Device management
• Click on “Options” menu on the homepage.
Option of ‘device management’ allows to
manage paired devices in case multiple
devices are added to your account.

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• Screen contains list of all the devices that you have connected in the
past, listed in reverse chronological order with respect to the time of
connection.

• Number below the device is the MAC address of the device which
can be used for identification or while submitting a query. Clicking on
the “I” button will display the devices calibration history on the app.

• Individual device box also contains the last data and time of
connection.

• Selected device is set as default and the application would auto

connect the next time it is opened and the device is switched ON.

• In case the device is switched OFF, the application will display a list
of other devices that are switched ON and are within the vicinity. You
can connect to any of them by clicking on the device.

Calibration
• Spirofy™ device must be calibrated with a 3L calibrated syringe for
every 10000 tests. Number of tests taken are mentioned below the
device name on the homescreen.

• Clicking on “Calibrate ” will open a calibration summary screen.

This will display previous calibration history, if any. You can toggle
between the previous data by selecting from the dates in the drop-
down window at the top right.

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• The summary details the test result along with actual values for a 3L
syringe calibration at slow medium and fast flow rates.

• Click on “Calibrate Device” to calibrate. Read and follow the

instructions displayed carefully and click on “Continue”.

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• Once you get “Ready to Calibrate” screen, calibrate the device
three times with a 3L calibration syringe at slow, medium and fast
flow rates, in that order. Ensure that the graphs are plotted below the
respective dotted line for each flow.

• Click on “Okay” once you have completed the calibration. The

app will display result for individual sets with the values which will be
automatically saved. Click on “Next” to go to calibrate menu or click
on “Close” to go to device home screen.

Help section
• Help section, in the options menu, contains few quick pointers and
links to help you in case of any problem while using the device or
app. It has the following sections:

• Guide for taking a test: Click on this option for step-wise instructions
on how to take a test using Spirofy™ device and application. You
can also take a mock test, in the “Guide for Taking First Test” option
to demonstrate the patient on how to perform Spirometry correctly.

• Frequently asked questions: This section contains a list of FAQ’s that a

user may face while using the device along with possible solutions for
each of them.

• User Manual: Click on this option to read this user manual on the
application.

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Raise a query: Use this section in case of a query that cannot be resolved
by referencing the “Help” section. Add your name, email address and
message in the text fields and click “Send”. You can also call directly via
the number given below.

Using Spirofy with Windows Application

User registration

1. Download Spirofy.exe from Spirofy Windows Portal and install on your

PC.

2. A dialogue box will appear prompting you to install the application.

Click on “RUN” to install the application. If the application requires
admin permission then click “Yes”.

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3. Select the default installation path and click “Next”

4. Click on “Install” and wait for the installation to finish.

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5. Create a desktop shortcut if you want and click on “Finish”.

User Registration
1. Open the application on your Windows PC. If you are a new user,
click on “I am New User”. If you are an existing user, click on “I am
Existing User”.

2. After clicking on the new user registration, fill in the details, click the
privacy policy checkbox and click on “Register”. An OTP dialogue
box will appear asking for OTP sent on the added email address.

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3. Check email inbox for OTP. Also, check spam folder in case not
received.

4. Enter the OTP from email in the dialogue box and click “Verify”. You
will see a “Successful” registration message.

5. You should see the application home screen. In case you are an
existing user, click on the “I am Existing User” in the first screen and
login using your registered email address and password. If fields are
correct, then app will take you to the app home screen.

6. In case you forget your password, click on “Forgot Password?”. Enter

your registered email address. An OTP will be sent on that address.
Enter the OTP and reset your PIN to login in again.

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Adding a device
1. Unlike Spirofy Android and iOS applications, windows application
requires a USB dongle to connect the device with the PC (Desktop or
Laptop).

Spirofy Dongle

2. First, open the Spirofy windows application and login in to your home
screen. In the home screen, click on “Add Device” button.

3. Application will check if a dongle has been connected. Insert the

dongle to be tested in one of the USB ports of the computer. Click
“Okay” once successfully inserted. The application will check and
move to the next screen.

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4. Application will prompt you to turn Spirofy spirometer ON. Switch it
ON and click “Okay” to continue

5. Ensure that only a single Spirofy device, one that is being tested, is
switched ON. This is to avoid confusion for the user to identify the
device. It should appear on the screen as seen below. Click on
“Connect” to add that device in the application.

6. Confirm that you want to add the device by clicking “Proceed”.

Device will be added in the home screen as seen below. You can
now create a case code and perform spirometry tests for that person.
To disconnect the device from the application, hover the cursor over
the centre of the device and click on “Disconnect.

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Adding a case code
1. In the added device home screen, click on “Add New Patient”.

2. Fill in the details of the patient as seen in the image below. Use your
working phone number to receive OTP during case code creation.

3. OTP screen will appear as below. Enter the 4 digit OTP and click
“Validate OTP”. You can also change the phone number in case
you have made a mistake before

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4. In case the OTP is not received within 30 seconds, click on the check
box below and manually add the case code.

5. The case code will be added in the device home screen.

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Taking a Test
1. Select the case code created for the test.

2. In the case code menu, select Pre or Post depending on the test.
Note that post can only be performed for a saved Pre test and only
after 15 minutes of the Pre test.

3. Once in the test menu as seen below, ask the patient to perform
Spirometry. For detailed instructions on how to perform Spirometry,
refer the section below.

4. The graph along with the values will appear on the screen. PEFR, FEV1,
FVC and FEF25-75 values will be displayed alongside the application.

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5. Click on the “Retry” button to another test in the same effort. Select
a minimum of three tests and click “Proceed” button to go to the
symptoms and comments section

6. Click on “Proceed” button one more time to go to the report

generation menu. From here, you can generate and print full size
and thermal printable reports.

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Generating Test Report
1. In the test report menu, click on “View Report” button.

2. A PDF report will open containing details of each of the three

spirometry manoeuvres with their individual parameters and graphs.

3. You can scroll though the PDF to assess the effort. You can also save
the reports in two formats. Click on “Download Report” to save the
full PDF in a designated documents folder.

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4. To take a print with Cipla Thermal Printer , click on “Print Report”
button. Click “OK”. Select the save path and click “Save”.

5. Open the PDF report on your PC via a PDF viewer software.

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Performing the test

Preparing the operator

• It is recommended that the operators wear personal protective
equipment (PPE) kit while performing lung function test during the
COVID pandemic OR follow the safety guidance as laid down by
local authorities.
• Protective mask as recommended by local policy should be used.
The duration of use of protective masks should comply with local
policy.
• Eye protection must always be worn e.g. goggles or face shield.
• Disposable gloves should be used at all times when testing. These
should be discarded after each patient and after cleaning of the
surfaces.
• Hand hygiene protocols as per local policy, should be followed,
before and after glove use.
• Reorganise testing schedules to include extra time for post-test
cleaning/decontamination procedures of the surfaces of the test
equipment and environment, allow at least 15 minutes to ventilate
the room (open windows, closed doors) and for PPE donning and
doffing.

Preparing the patient

• It is recommended that the patients should be administered a
symptoms screening questionnaire on arrival. Body temperature
should be checked in order to verify, if they are likely to have COVID
infection. OR Follow the guidance as laid down by local authorities.
• Use of masks is recommended for all patients attending for tests.
• Have patient assume the correct posture - the patient should be
seated erect, with shoulders slightly back and chin slightly elevated.
• A chair with arms (to prevent falling sideways should syncope occur),
without wheels, and with a height adjustment so that the feet are
flat on the floor should be used. A smaller chair or a raised footstool
should be provided for small adults.

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• Subjects should wear comfortable clothes that allow full expansion of
chest and abdomen.
• Dispense hand sanitizer for the patient
• Confirm patient identification, age, birth sex, ethnicity, etc.
• Measure weight and height without shoes
• Tissues or paper towels should be offered to help patients deal with
secretions.
• Well-fitting dentures are usually left in place.
• Patients should avoid intake of caffeine‑containing products (tea,
coffee, and cola) for at least 6 h and alcohol for at least 4 h, before
the test.
• Patients should not eat a large meal for at least 2 h before spirometry
and avoid smoking for at least 1 h.
• Vigorous exercise should be avoided for at least 30 min before the
procedure.
• Instructions on withholding medications should be given to the patient
at the time of making the appointment. The operator must record the
type and dosage of any inspired, oral, or injected medication that
may alter lung function and when the drugs were last administered.
The operator should record observed signs or symptoms such as
cough, wheeze, dyspnea, or cyanosis

Preparing the instrument

Please refer to section 4 for the steps
• Maximise the use of single use consumables and dispose of the items
with care e.g. nose clips, rubber mouthpieces, etc.
• Where reusable items are utilised, they should be managed carefully
and should be thoroughly cleaned as recommended by local
infection control policy
• Follow strictly regular equipment cleaning protocols as per local
guidance.

Performing a test
• Have patient assume the correct posture and attach noseclip
• Instructions to patients -

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• Inspire completely and rapidly with a pause of ≤ 2 s at total lung
capacity (TLC)
• Place mouthpiece in mouth, close lips around the mouthpiece
• Expire with maximum effort until no more air can be expelled, while
maintaining an upright position
• Repeat for a minimum of three maneuvers, usually no more than
eight for adults
• Check FEV1 and FVC repeatability and perform more maneuvers as
necessary
• Within‑maneuver acceptability criteria for spirometry
• An acceptable spirogram should be free from the following visual
artifacts
• Cough during the 1st s of exhalation
• Effort that is not maximal throughout
• Obstructed mouthpiece
• Early termination or cut‑off
• Glottis closure that influences the measurement
• Leak
• Start‑of‑test criteria: Extrapolated volume <5% of FVC or <150 mL,
whichever is greater
• End‑of‑test criteria
• The volume‑time curve shows no change in volume (<25 mL) for at
least 1 s, and the subject has tried to exhale for at least 6 s OR The
subject cannot or should not continue further exhalation
• Between‑maneuver repeatability criteria for spirometry
• After three acceptable spirograms are obtained, the following
criteria should be applied:
• The two largest values of FVC must be within 150 mL of each other*
• The two largest values of FEV1 must be within 150 mL of each other*
• If both of these criteria are met, the test session may be concluded
• If both of these criteria are not met, testing should be continued until:
• Both of the criteria are met in the subsequent acceptable spirograms
OR

37
• A total of eight tests have been performed (optional) OR
• The subject cannot or should not continue further
• Within maneuver acceptability criteria for peak expiratory flow
maneuver
• No hesitation
• No cough
• No leak at mouth
` Between‑maneuver repeatability criteria for peak expiratory flow
maneuver
• At least three maneuvers should be performed
• Largest two of three acceptable maneuvers must be within 0.67 L/
(40 L/min)
• If the above criterion is not met, up to two additional maneuvers can
b performed
• Ensure that the Spirofy™ device is within the calibration window.
Assemble the device with an unused airway.
• Ensure that the device is connected to the application with the
correct case code.
• Ensure minimal to no excessive airflow environment as it would affect
the readings from Spirofy™.
• Hold the Spirofy™ device next to your cheek, holding it steady and
click on “Take A Test”.
• Once “Ready for Test” screen is observed, ask the patient to
slowly clench the Spirofy™ mouthpiece in his/her mouth. Ensure
no accidental exhalation during this process. If an exhalation is
detected, the initial inhalation before the test would be recorded
and result in bad test.
• Ask the patient to deeply inhale through the device, followed by
forced exhalation.
• Ensure that the patient exhale for a minimum of 6 seconds or until the
“Beep” is heard.
Steps to connect and pair the thermal printer with the phone
• Download CIE Mobile Print application from Apple app store or
Google Play Store.

38
• Open the application. For window that says” Printer disconnect
delay set to 6 seconds”, click OK. Turn phone Bluetooth ON.
• Switch ON the thermal printer by long pressing the power button.
The paper roll should move forward just a bit; power LED would blink
Green and Bluetooth LED would blink Blue.
• In the CIE app, select the following settings:
• Printer type: Bluetooth printer
• Printer Size: 3 Inch
• Image rendering Algorithm: Greyscale
• Print Scaling: No
• Force Landscape Printing: Unchecked
• Set printer disconnect delay: 6 seconds
• Click “CLEAR PREF PRINTER”. Then click “SELECT PREF PRINTER”. Click
on “SCAN RECIEPT PRINTER”. Ensure that only a single thermal printer
is Switched ON at this point as multiple printers may cause confusion
while pairing.
• Click on printer with name in the format “CIE-EXCEL-####”. The
printer is paired with the phone.
• Reports can be printed after opening them in Drive PDF Viewer
in Android, clicking in the top right button, select “Print”. In the
dropdown in the print screen, select ECS/POS Printer. Ensure Paper
size is 80 mm thermal and copies is 1. Click on Printer icon to print.

39
Post test and previous reports

• Post Bronchodilator test can be performed for any regular test for a
case code between 15 minutes and 20 hours after the Pre test.

• To take a Post Test, click on the case code of the patient and select
the “Post” option.

• Follow the same procedure as taking a Pre test.

• Reconnection of device

• Last connected device would be set as the default device for

connection.

• For auto-connect feature, open the application and Switch Bluetooth

ON.

• Switch ON Spirofy™ device, the device should auto-connect with

the app. Connection status in the home screen should change from
Disconnected to Connected. If auto connect fails, restart the device
or add manually in device management section.

Resetting Password
In case you forget the password, don’t worry! Go to the Login page, click
on “Forgot Password?”. Enter your email address. Enter OTP received on
the email and set new password.

40
Specifications

Product Cipla Spirofy

Flow Detection Principal Differential pressure device pneumotach

Volume Detection Sampling at 125Hz

Maximum test duration 25 seconds

Maximum displayed volume 7 Litres

Maximum displayed flow 12 L/m

Operating temperature range 10 °C - 40 °C

Operating humidity range 35% - 65%

Performance standards ATS 2005

EMI/EMC standards IEC 6061

Weight (Device + Dock) 350 grams

Storage temperature 25 °C

Ambient pressure condition 850hPa - 1150hPa

Storage humidity 60%

Minimum phone requirements iPhone 5s or above, iPad 4 or above,

iOS 10 or above, Android OS 8.0 phone/tablet with Quad core processor,
3 GB RAM or above. Intel core 2 duo or above, AMD FX6300 or above. 4
GB RAM, Windows 7 or above,

41
Maintenance of the instrument

• Periodic cleaning and maintenance of any medical equipment is

crucial.

• Ensure a dust free environment for the Spriofy™to rest.

• Regularly clean the device and the charging dock with a damp
cloth, making sure no exposed electronics like the charging port,
contact pins or the airway mounting points. Later, dry the device
with a paper towel.

• Inspect the device periodically and look for any unfamiliar noises,
loose panels etc.

42
Troubleshooting

This section is divided into three sections: issues related to a) device

hardware, b) device application and c) printer hardware. The same
information is also available in the ‘Help’ section of the application. It is
strongly recommended that you refer ‘Help’ section in the application
while raising a complaint for any of the issues below.

Issues
1. Device: Issues related to the Spirofy™ device hardware
1.1 Airway: Issues related to the Spirofy™ airways
1.1.1 Package: Issues related to Spirofy™ airways packaging
1.1.1.1 Wrong/Torn:
• Airway pouch has misprint or print is difficult to read: Check for
expiration date. If visible, then OK to use.
• Expiration date is blurred: Airway not to be used.
• Packaging is torn: Check the extent of tearing. If airway inside
is sealed, then OK to use.
• No packaging with airway: Do not use loose, unpacked
airways.
• Packaging is dirty/cloudy from the inside or outside: Do not
use airway.

1.1.1.2 Airway disassembled/ broken inside of the packaging:

• Airway is broken/cracked inside the packaging: Do not use a
broken or cracked airway as it may affect the readings.
• Airway is disassembled inside the packaging:

1. Check for breakages and cracks on the airway and

individual parts such as mesh, mouthpiece and body.

2. Check if the airway is within the expiration period. If yes,

reassemble the airway using the following procedure.

a. Lock the mesh in place on the airway body using the

locking indents. Ensure tight fitment.

43
 b. Attach the mouthpiece over the mesh using similar
locks. Ensure tight fitment.

c. Make sure that the filter holes are lined next to each
other on the same side.

d. Insert the filters in the filter hole and attach filter plugs
over it.

1.1.2 Readings: Issues with the output/test readings from the airways

1.1.2.1 Low

• Readings are abnormal lower than expected:

1. Remove the airway from the device. Place it gently over

the nozzle and push the airway using top slide cover without
putting any excessive force.

2. Check for correct fitment in section 1.1.3.

3. Check if the patient is holding the airway and performing

the test correctly. Check for any leaks from the edges of the
mouth.

4. Check integrity of airway in section 1.1.1.2.

5. Ensure that Spirofy™ device battery is charged above 80%.

1.1.2.2 Erratic

• Readings are not similar in multiple efforts on the same airway:

1. Make sure that the device was correctly calibrated (zero flow
through the device during calibration) correctly in between
tests.

2. Check if the patient is holding the airway and performing

the test correctly. Check for any leaks from the edges of the
mouth.

3. Make sure that patient does not accidentally spit inside the
airway while taking the test. Replace the airway with a new
one in case of spit or excess moisture of any kind.

4. Check for correct fitment in section 1.1.3.

5. Check integrity of airway in section 1.1.1.2.

44
 6. Ensure that Spirofy™ device battery is charged above 80%.

1.1.2.3 High

• Readings are abnormal higher than expected:

1. Make sure that the device was correctly calibrated (zero flow
through the device during calibration) correctly in between
tests.

2. Check if the patient is holding the airway and performing

the test correctly. Check for any leaks from the edges of the
mouth.

3. Make sure that patient does not accidentally spit inside the
airway while taking the test. Replace the airway with a new
one in case of spit or excess moisture of any kind.

4. Check for correct fitment in section 1.1.3.

5. Check integrity of airway in section 1.1.1.2.

6. Ensure that Spirofy™ device battery is charged above 80%.

1.1.3 Fitment: Issues with the fitment of the airway with Spirofy™
device

1.1.3.1 Loose fit

• Airway assembly is loose: Assemble the airway tightly as per

section 1.1.1.2

1.1.3.2 Filter missing

• Airway is missing one or both filters: Do not use the said airway.
Use a fresh airway with both the filters in place.

1.1.3.3 Airway in improper direction

• Airway attached in incorrect direction: Remove the airway and

attach it over the device such that the mouthpiece is on side of
the Power button and LED.

1.2 Hardware

1.2.1 Bluetooth Connection

• Paired Spirofy™ device not detected in the application:

45
 1. Switch the Spirofy™ device OFF then switch ON.

2. Ensure that mobile phone Bluetooth and Location services are

turned ON.

3. Ensure that Spirofy™ device to be connected is switched ON.

4. Ensure that Spirofy™ device is charged above 80%. Charge

the device for 3 hours for 80%.

5. Ensure that Spirofy™ device is within 8 feet of the mobile

phone.

• Un-Paired Spirofy™ device is not detected in the pairing menu of

the application:

1. Switch the Spirofy™ device OFF then switch ON.

2. Ensure that mobile phone Bluetooth and Location services are

turned ON.

3. Ensure that Spirofy™ device to be connected is switched ON.

4. Ensure that Spirofy™ device is charged above 80%. Charge

the device for 3 hours for 80%.

5. Ensure that Spirofy™ device is within 8 feet of the mobile

phone.

• Spirofy™ device disconnected in between tests:

1. Ensure that no more than 10 tests are performed in one test

window. This includes any demo tests or poor attempts.

2. Ensure that mobile phone Bluetooth and Location services are

turned ON during the tests.

3. Ensure that Spirofy™ device in to be connected is turned ON

during the test.

4. Ensure that Spirofy™ device is charged above 80%. Charge

the device for 3 hours for 80%.

5. If the device is disconnected between tests, the “Retry” button

will change to “Connect”. Click on it to reconnect the device
and continue with the tests.

6. Ensure that Spirofy™ device is within 8 feet of the mobile

phone.

46
1.2.2 Buttons

• Power button getting stuck inside

1. Spirofy™ power button can get stuck inside the device if

pressed incorrectly or with too much force.

2. To remove the button from the plastic housing, push the button
completely inside the housing.

3. While compressed, align the button such that its edge is not
touching the plastic border.

4. Slowly release the button outside to get it back to normal

position.

• Spirofy™ device is not turning ON/LED not glowing Blue after

pressing the button

1. Check the device battery. Charge the device for 3 hours and
check LED again.

2. Check if the device is detected/connected via the

application.

1.2.3 Pressure Sensor

• Readings from Spirofy™ device are wrong/erratic even after all

the corrections/troubleshooting

1. Ensure that the device is charged to 80 % and connected to

the application.

2. Ensure that the airway and top slide cover are attached in the
correct orientation and a new airway is used.

3. Ensure that the device is calibrated and has passed calibration

as per guidelines.

1.2.4 Battery

• Spirofy™ device battery is not getting charged on the dock

1. Ensure that the dock is functional by connecting it to power

source using the provided adapter and charging cable. The
dock LED should turn GREEN when connected to power.

2. Ensure that the adapter and power cable are properly

47
 attached to the power source and the adapter and dock
respectively.

3. Check if the charging adapted and cable are functional by

referring section 1.3.4.3.

• Charged Spirofy™ battery is draining faster than expected, even

on standby

1. Ensure that Spirofy™ is switched OFF when not in use.

2. Do not overcharge your Spirofy™ spirometer.

1.3 Dock: Issues with usability or functionality of charging dock

1.3.1 Changing problem/Springs: Issues with charging springs on the

dock

1.3.1.1 Loose contact:

• Dock LED fluctuating between RED and GREEN, indicating loose

contact

1. Press down the Spirofy™ device on the lock with a little bit of
force. Check if the Dock LED turns from RED to Green.

1.3.1.2 Spring action incorrect

• Gap observed between Spirofy™ device and dock when placed

for charging

1. Confirm loose contact as per instructions in 1.3.1.1.

2. Continue to use if Spirofy™ device is able to charge correctly.

1.3.2 LED Interface: Issues with the LED interface on the charging
dock

1.3.2.1 RED

• Dock LED is RED when the dock is connected to power source and
Spirofy™ device is placed over dock

1. Spirofy™ device is being charged. Continue to charge the

device till the LED turns GREEN.

• Dock LED is RED when the dock is connected to power source and
no device is placed over dock

48
 1. Contact customer care

• Dock LED is RED when the dock is not connected to power and
Spirofy™ device is placed over the dock

1. Contact customer care

1.3.2.2 Not working

• Dock LED is not turning either RED or GREEN

1. Connect the dock to power supply and turn the power ON.

2. Check if the dock LED turns GREEN.

3. Place a Spirofy™ device on the above dock. LED should glow

either RED or GREEN.

1.3.2.3 Never green

• Dock LED is does not turn GREEN

1. Connect the dock to power supply and turn the power ON.

2. Check if the dock LED turns GREEN.

3. Place a charged Spirofy™ device on the above dock. LED

should glow GREEN.

1.3.3 USB Cable: Issues with USB power cable

1.3.3.1 Loose:

• Cable fitment to the dock is loose

1. Check if the Spirofy™ device is able to charge.

2. You can use any other good quality cable if current cable is
out of warranty.

1.3.3.2 Connection broken

• Port on the dock is broken out of the box

1. Contact customer care

• Port on the charging cable is broken out of the box

1. Contact customer care

1.3.3.3 Wrong fit

49
• Cable received in the box pack does not fit with the port on the
dock

1. Contact customer care

1.3.3.4 Missing in pack

• No charging cable was received with the box pack

1. Contact customer care

1.3.4 Charging adapter: Issues with the charging adapter received in

the box:

1.3.4.1 Missing

• No charging adapter was received with the box pack

1. Contact customer care

1.3.4.2 Heated

• Charging adapter tends to overheat while connected to the

power and charging the device

1. Replace the power adapter with a good quality alternative.

1.3.4.3 Not working

• The charging adapter provided in the box is not charging the

device

1. Contact customer care

1.4 Top Slide Cover: Issues with the top slide cover

1.4.1 Broken/Bent locks

• Any number of the four locks on the top slide cover are bent/
broken

1. Contact customer care

1.4.2 Excess plastic

• Excess plastic residue on the top slide cover

1. Check if you are able to take a test using the device and top slide
cover.

50
 1.4.3 Excess force required to lock the top slide cover

• Difficulty in locking top slide cover with the Spirofy™ device.

1. Check that the airway and top slide cover are placed in the
correct orientation.

2. Attach top slide cover as per instructions given in the user

manual.

2. Application

2.1 Login/Server

• Unable to create and account/register

1. Check if you have a working internet connection.
2. Check spam folder in your email inbox.
3. Check if the application has been granted all of the required
permissions.
4. Clear the application from the multitasking menu and launch
again.
5. Uninstall and reinstall the application.
6. Restart the phone and retry.

• Unable to log in to an existing account

1. Check your login credentials.
2. Check if you have a working internet connection.
3. Check if the application has been granted all of the required
permissions.
4. Clear the application from the multitasking menu and launch
again.
5. Uninstall and reinstall the application.

• Unable to create a case code

1. Check if you have a working internet connection and mobile
network reception.
2. Check if the mobile number submitted is correct and
operational.
3. Check if the OTP submitted in the application is correct.

51
 • OTP not received on email
1. Check if the application and email client have working stable
and reliable internet connection.
2. Check if correct email address was submitted to the
application.
3. Check the SPAM folder of the email address.

• OTP not received on mobile number

1. Check if correct mobile number was submitted.
2. Check that the application has a working internet connection.
3. Check that the mobile number has network reception.

2.2 Plotting/Test

2.2.1 Graph

• Graphs are not getting plotted while taking a test

1. Check that the device is connected to the application via
Bluetooth.
2. Retry taking test while making sure that device is properly
calibrated, ensuring zero flow in the airway during calibration.
3. Turn OFF any power saving modes on the phone as it may
affect the app performance.
4. Ensure Spirofy™ device is within 6 feet of the phone.

• Lag in plotting of graphs while taking a test

1. Do not take more than 8 tests per patient in each test window.

2. Turn OFF any power saving modes on the phone as it may

affect the app performance.

3. Remove any background applications open on the phone as

it may hamper performance.

4. Ensure Spirofy™ device is within 6 feet of the phone.

5. Restart the application.

• Plotted graphs are incorrect in nature

1. Ensure correct fitment of the airway with the Spirofy™ device

52
 with top slide cover attached.

2. Ensure zero flow through the device during calibration before

every test.

3. Ensure that the patient does not cough or spit in the airway
during a test. Replace the airway if cough or saliva is seen.

2.2.2 Calibration

• Spirofy™ device is repeatedly failing in 3L calibration

1. Ensure that the syringe is calibrated as per manufacturer’s

guidelines and recommendations.

2. Ensure a new airway is used and is attached correctly to the

device.

3. Ensure that the fitment of the device to the syringe is via an

appropriate coupling and the connection is leak proof.

4. Follow the calibration instructions correctly. Do not plunge the

syringe while the device is getting ready for calibration.

• Graphs are not getting plotted while taking a test

1. Check that the device is connected to the application via

Bluetooth.

2. Retry taking test while making sure that device is properly

calibrated, ensuring zero flow in the airway during calibration.

3. Turn OFF any power saving modes on the phone as it may

affect the app performance.

4. Ensure Spirofy™ device is within 6 feet of the phone.

• Lag in plotting of graphs while taking a test

1. Turn OFF any power saving modes on the phone as it may

affect the app performance.

2. Remove any background applications open on the phone as

it may hamper performance.

3. Ensure Spirofy™ device is within 6 feet of the phone.

4. Restart the application

53
• Plotted graphs are incorrect in nature

1. Ensure correct fitment of the airway with the Spirofy™ device

with top slide cover attached.

2. Ensure zero flow through the device is getting ready before

every test before every test.

2.2.3 Pre/Post test results/reports

• Report values are different from the test values

1. Ensure that correct graphs were selected before clicking

“proceed” in the test menu.

• Full or Print report is not generated correctly

1. Ensure that the test was taken correctly and correct values are
seen in the report menu.

2. Close the application from the multitasking menu and launch

it again.

3. Attempt to generate a report again.

• Previous calibration details are not visible

1. Ensure that you have logged in with the correct account as

used during previous calibration.

2. In case you have logged in to a different device with the same

account, ensure that the calibration information is synced
before logging out.

2.3 Retrieval: Issues with syncing test data or retrieving test data after
log out and log in

• Unable to see previous data after logging in to account

1. Previous data must be synced for it to be visible after logging

in again. Ensure that the generated data was synced before
logging out of a device.

• Unable to sync generated data to cloud

1. Ensure that the phone has a working internet connection with

sufficiently high speed.

54
 2. Ensure that Spirofy™ application is provided with the required
permissions.

2.4 Connection

2.4.1 Device: Connection issues between device and application

due to application

• Application unable to add a new Spirofy™ device

1. Ensure that the Spirofy™ device is charged for at least two

hours and switched ON while pairing.

2. Ensure that Bluetooth and location services are switched ON

during the pairing process.

3. Ensure that the Spirofy™ device is within 6 feet of the phone.

• Application unable to connect to an added Spirofy™ device

1. Ensure that the Spirofy™ device is switched ON and charged

above 80%.

2. Ensure that the Bluetooth and location services on the phone

are switched ON.

• Lost connection between device and application in the middle of

the test

1. “Retry” button would be changed to “Connect” button.

2. Click on “Connect” and wait till it becomes “Retry” again.
3. Click on “Retry” and continue the test.
3 Printer
3.1 Hardware
3.1.1 Printer Head

• Not printing anything on given command.

4. Check BLE connection

5. Check proper position on roller paper side.

6. If nothing works, Contact customer care

• Printer head is shaking back/ forth while connecting roller

1. Contact customer care

55
 • Printing paper getting stuck inside the printer head.

1. Ensure that the printer is charged for at least two hours.

2. Ensure that the paper roll alignment is correct.

3. Check that the paper lid is properly closed.

3.1.2 Printer Buttons

• ON/OFF button not working on pressing

2. Ensure that the printer is charged for at least 2 hours.

3. Check if you are able to press the button down.

4. Check if any of the four LEDs are lighting up.

• ON/OFF button not getting pressed

2. Contact customer care

• Feed button not working

1. Ensure that the printer is charged for at least 2 hours.

2. Check if you are able to turn ON the printer.

3. Check if any of the four LEDs are lighting up.

4. Check if you are able to press the button down.

• Feed button not getting pressed

3. Contact customer care

3.1.3 Printer LEDs

• BLE Blue LED not glowing

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check if you are able to connect the printer to the phone via
Bluetooth by giving the “Test Printer”.

4. Try printing a thermal report. If the report is coming out fine,

then only the LED may be damaged.

56
• RED LED not glowing on error occurred

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check if you are able to connect the printer to the phone via
Bluetooth by giving the “Test Printer”.

4. Try printing a thermal report. If the report is coming out fine,

then only the LED may be damaged.

• Green LED not glowing on switching printer on

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check if you are able to connect the printer to the phone via
Bluetooth by giving the “Test Printer”.

4. Try printing a thermal report. If the report is coming out fine,

then only the LED may be damaged.

• Charging LED not glowing when connected to the charger

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check if you are able to connect the printer to the phone via
Bluetooth by giving the “Test Printer”.

4. Try printing a thermal report. If the report is coming out fine,

then only the LED may be damaged.

3.1.4 Printer plastic head

• Printer Plastic head is shaking and do not remains firm while

connecting roller on printer head

1. Contact customer care

57
 3.1.5 Printer plastic roller head

• Roller head is not firmly fitting on printer head

1. Check and ensure that the alignment of roller head and

printer head is proper.

3.1.6 Print Paper

• Printer paper is not coming out symmetrically from printer head

while printing

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check PDF file that you are giving for print.

4. Ensure that the paper roll alignment is correct.

5. Check that the paper lid is properly closed.

• Print is blur or erratic

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check PDF file that you are giving for print.

4. Ensure that the paper roll alignment is correct.

• Print is blank

1. Ensure that the printer is charged for at least two hours.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check PDF file that you are giving for print.

4. Ensure that the paper roll alignment is correct, and the paper
roll is installed correctly. Ensure that adequate length of roll is
available.

3.1.7 BLE Connection

• Paired printer not getting detected by Spirofy™ application

58
 1. Charge the printer for at least two hours and Switch the printer
ON.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check if the printer prints out “Hello Printer” if you click “Test
Printer” from the CIE application.

4. Remove the printer by clicking “Clear Pref Printer” and try

adding it again.

5. Try operating the printer using CIE application on a phone of a

different model/manufacturer.

• Un-paired printer not getting detected by Spirofy™ application

1. Charge the printer for at least two hours and Switch the printer
ON.

2. Check if you are able take a test print by holding the feed
button and pressing the power button.

3. Check that the printer is not simultaneously connected to a

different phone at the same time.

4. Check if the printer prints out “Hello Printer” if you click “Test
Printer” from the CIE application.

5. Remove the printer by clicking “Clear Pref Printer” and try

adding it again.

6. Try operating the printer using CIE application on a phone of a

different model/manufacturer.

• BLE connection lost in between printing process

1. Check if the printer has enough battery. Charge the printer for
two hours or use in plugged-in mode.

2. Check if paper roll has adequate length of paper remaining.

3. Tear off partially printer report and re-print the report.

59
9. Abbreviations of parameters

FVC Forced Vital Capacity (expiratory)

FEV1 Forced Expiratory Volume (1 sec).
FIVC Forced Vital Capacity (inspiratory)
PEFR Peak expiratory flow rate
FEV3 Forced Expiratory Volume (3 sec)
FEF25 Forced expiratory flow (25% of the pulmonary
volume)
FEF50 Forced expiratory flow (50% of the pulmonary
volume)
FEF75 Forced expiratory flow (75% of the pulmonary
volume)
FET Forced Expiratory Time
FEF25-75 Forced expiratory flow (25 to 75% of the pulmonary
volume)
10. Regulatory certificates

11. Bibliography

• Recommendation from ERS Group 9.1 (Respiratory function

technologists /Scientists) Lung function testing during COVID-19
pandemic and beyond. Adapted from ERS 9.1 Statement on
lung function during COVID-19 Final with Contributors.pdf |
Powered by Box. As accessed on 25th November 2020.

• Christopher DJ et al. Pulmonary function testing during the

COVID-19 pandemic: Consensus recommendations by
the Indian Chest Society. Lung India [Epub ahead of print].
Available from: https://www.lungindia.com/preprintarticle.
asp?id=298431

• Aggarwal AN et al. Joint Indian Chest Society‑National College

of Chest Physicians (India) guidelines for spirometry. Lung India
2019;36:S1-35.

• Standardization of Spirometry 2019 Update: An Official

American Thoracic Society and European Respiratory Society
Technical Statement. Am J Respir Crit Care Med 2019;200:e70–
e88

60
61
62