Spirohome Clinic User manual

Ultrasonic Spirometer

User Manual

Welcome to SpiroHome

Before using your SpiroHome Clinic device and mobile application, please ensure that

you have read this user manual, all labeling and information provided the product. This

user manual is for SpiroHome Clinic (Ref No: 02000). The user manual can be

downloaded and/or printed from SpiroHome websites and SpiroHome Apps.

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CONTENTS

REVISION RECORD 1

CONTENTS 3

INTRODUCTION 4

PRODUCT DESCRIPTION 4

WHAT’S IN THE BOX 4

INTENDED USE 4

RESTRICTIONS ON USE AND CONTRAINDICATIONS 5

PARAMETERS 6

OPERATION 9

OPERATING ENVIRONMENT 9

SETTING UP YOUR DEVICE 9

DEVICE INDICATORS 11

PERFORMING A LUNG FUNCTION TEST 12

General Method For Performing a Spirometry Test with The SpiroHome Clinic: 12

Types of Breathing Maneuvers 14

End of the Tests 19

Understanding the test quality 20

SIGNS AND SYMBOLS 21

TECHNICAL FEATURES 23

SAFETY WARNINGS AND PRECAUTIONS 23

MAINTENANCE 25

CALIBRATION-CHECK 26

Preparation of Calibration Check 26

CLEANING AND DISINFECTION 27

THE SPIROWAY DISPOSABLE 28

BATTERIES 29

DISPOSAL OF SpiroHome 30

TROUBLESHOOTING 30

ORDERABLE ACCESSORIES 32

TERMS OF WARRANTY 33

ELECTROMAGNETIC COMPATIBILITY 33

MANUFACTURER INFORMATION 37

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1. INTRODUCTION

1.1. PRODUCT DESCRIPTION

The SpiroHome Clinic is a portable spirometer that pairs (via Bluetooth®) and operates with

smart devices running with iOS, Android, or Windows. The SpiroHome Clinic measures and

displays certain parameters of the lung function of the user. The user performs a spirometry test

as described in the Performing A Lung Function Test section of this user manual. Briefly, as the

user exhales into the device through its mouthpiece, internal ultrasonic sensors detect the

velocity of the expired air, the device converts this information into spirometric data and displays

it via the SpiroClinic application. The SpiroClinic app prompts and guides the user throughout

the test for accurate data collection and registration.

The app can be downloaded on Apple’s App Store, Google Play Store, Microsoft Store. The

device is powered by 2 x AAA batteries. The SpiroHome Clinic works with the SpiroWay

Disposable mouthpiece.

1.2. WHAT’S IN THE BOX

Your SpiroHome Clinic box contains:

· SpiroHome Clinic Device (a)

· SpiroHome Clinic Cap (b)

Caution: Please check to ensure that there is no visible damage on any of the components of

the SpiroHome Clinic. If the damage is present, do not use or attempt to repair the device,

please contact the manufacturer directly.

1.3. INTENDED USE

The SpiroHome Clinic is intended to be used as a portable spirometer used in lung function

testing for several parameters. See Parameters section for more information about measured

parameters. The SpiroHome Clinicis indicated for:

- children (over the age of 5), adolescents or adults who have been diagnosed with a

chronic pulmonary disease including, but not limited to, asthma, chronic obstructive

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pulmonary disease and cystic fibrosis. These measurements can be used for the

detection, assessment and monitoring of diseases affecting the lung function.

and should be used by:

- Healthcare professionals, test operators, physicians, clinicians, occupational health

professionals etc.

1.4. RESTRICTIONS ON USE AND CONTRAINDICATIONS

Any diagnosis of conditions or prescribed treatments should be made only by a qualified

healthcare professional who, in addition to the test results provided by SpiroHome Clinic will

take into consideration the outcomes of a medical examination, the patient’s clinical history and

results of any other tests deemed necessary.

SpiroHome Clinic is a multi-user device. The device can log the information and test results that

belong to each specific patient. For each new patient, a new patient account must be created on

the SpiroClinic app, so that each user's personal information and test results can be stored and

logged.

A new SpiroWay Disposable mouthpiece must be used for each new user.

The spirometry test should only be performed by users who do not experience any shortness of

breath and are in good health for performing a lung function test. Test results of patients who do

not meet these conditions may not be reliable. A correct spirometry test depends greatly on the

patient’s ability to correctly perform the expiratory/inspiratory maneuver as described in this

manual. Failure to perform a correct maneuver may lead to inaccurate and unacceptable

results. The device should not be used if the accuracy and reliability of test results may be

jeopardized by external factors.

Performing spirometry can be physically demanding. The forced expiratory maneuver used in

spirometry increases intrathoracic, intraabdominal, and intracranial pressures. Potential risks of

spirometry are primarily related to maximal pressures generated in the thorax and their impact

on abdominal and thoracic organs, venous return and systemic blood pressure, and expansion

of the chest wall and lung. The physical effort required can increase myocardial demand.

Caution must be used for patients with medical conditions that could be adversely affected by

these physiological consequences. Although such risks are likely to be minimal for spirometry in

most patients, the potential risks associated with testing should always be weighed against the

benefit of obtaining information about lung function. Spirometry should be discontinued if the

patient experiences pain during the maneuver. Patients with potential contraindications that

would prevent testing in the primary care setting may be tested in a pulmonary function

laboratory where operators are more experienced and there may be access to emergency care

if needed. Furthermore, because spirometry requires the active participation of the patient,

inability to understand directions or unwillingness to follow the directions of the operator will

usually lead to submaximal test results.

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Relative Contraindications for Spirometry;

Due to increases in myocardial demand or changes in blood pressure;

➢Acute myocardial infarction within 1 wk

➢Systemic hypotension or severe hypertension

➢Significant atrial/ventricular arrhythmia

➢Noncompensated heart failure

➢Uncontrolled pulmonary hypertension

➢Acute cor pulmonale

➢Clinically unstable pulmonary embolism

➢History of syncope related to forced expiration/cough

Due to increases in intracranial/intraocular pressure;

➢Cerebral aneurysm

➢Brain surgery within 4 wk

➢Recent concussion with continuing symptoms

➢Eye surgery within 1 wk

Due to increases in sinus and middle ear pressures;

➢Sinus surgery or middle ear surgery or infection within 1 wk

Due to increases in intrathoracic and intraabdominal pressure;

➢Presence of pneumothorax

➢Thoracic surgery within 4 wk

➢Abdominal surgery within 4 wk

➢Late-term pregnancy

Infection control issues;

➢Active or suspected transmissible respiratory or systemic infection, including tuberculosis

➢Physical conditions predisposing to the transmission of infections, such as hemoptysis,

significant secretions, or oral lesions or oral bleeding

Please ask the patient if they have or suspect having any of the conditions above before use of

the SpiroHome Clinic.

1.5. PARAMETERS

The SpiroHome Clinic records and displays the following spirometry data:

Parameters

Definition

Unit

FVC

Forced Vital Capacity — The volume of air that can forcibly be

blown out after full inspiration

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FEV0.75

Forced Expiratory Volume within 0.75 seconds: The volume of air

that can forcibly be blown out within 0.75 seconds, after full

inspiration.

FEV1

Forced Expiratory Volume within 1 second

FEV3

Forced Expiratory Volume within 3 seconds

FEV6

Forced Expiratory Volume within 6 seconds

FEV0.75/FVC

The ratio of FEV0.75 to FVC

FEV1/FVC

The ratio of FEV1to FVC

FEV3/FVC

The ratio of FEV3to FVC

FEV6/FVC

The ratio of FEV6to FVC

PEF

Peak Expiratory Flow — The maximal flow rate achieved during

the maximally forced expiration initiated at full inspiration.

L/s

MMEF

Mean Mid-Expiratory Flow — synonymous with FEF25-75

L/s

FEF25

Forced Expiratory Flow at 25% of vital capacity — synonymous

with MEF75

L/s

FEF50

Forced Expiratory Flow at 50% of vital capacity — synonymous

with MEF50

L/s

FEF75

Forced Expiratory Flow at 75% of vital capacity —synonymous

with MEF25

L/s

FEF25-75

Forced Expiratory Flow from 25% to 75% of vital capacity —

synonymous with MMEF

L/s

MET25-75

Mıd-Expıratory Tıme — synonymous with FET25-75

FEV0.75/FEV6

The ratio of FEV0.75 to FEV6

FEV1/FEV6

The ratio of FEV1to FEV6

FEF50/FVC

The ratio of FEF50 to FVC

1/s

MMEF/FVC

The ratio of MMEF to FVC

1/s

FET

Forced Expiratory Time

BEV

Back extrapolated volume

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FIV1

The forced inspiratory volume within 1 second

FIVC

Forced inspiratory vital capacity

PIF

Peak inspiratory flow

L/s

FIF25-75

Forced inspiratory flow at 25% of vital capacity — synonymous

with MIF75

L/s

FIV1/FIVC

The ratio of FIV1to FIVC

R50

(FEF50/FIF50)

The ratio of flow at 50% of expiration and flow at 50% of

inspiration — synonymous with FEF50/FIF50

Vital capacity, from slow expiration

VCin

Inspiratory vital capacity, from slow inspiration

VCex

Expiratory vital capacity, from slow expiration

ERV

Expiratory reserve volume

IRV

Inspiratory reserve volume

Inspiratory capacity from end of tidal breathing

Respiratory frequency

1/min

Tidal Volume

MVV

Maximum voluntary ventilation

L/min

MVV6

Maximum plat voluntary ventilation for 6 seconds

L/min

MVVtime

Duration of the trial in seconds

The recommended number of trials per spirometry session is 3, however, the user may perform

up to 8 trials. The best values obtained from the spirometry tests performed in one session are

displayed on the app interface. Users and healthcare professionals have the option to view the

results of each spirometry trial performed in a spirometry session separately.

The device also provides a reference value (obtained from large epidemiological studies) based

on the patient’s height, weight, age, sex and ethnicity. Test results from spirometry tests are

compared to the reference value and displayed as a percent predictive value indicator of the

patient’s respiratory health. The patient’s personal best value for a spirometry session should be

discussed with them for medical interpretation.

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Caution: Interpretation of spirometry results or diagnosis of medical conditions, if any, is to be

made by a physician or allied health care professional with sufficient training in the performance

and interpretation of spirometry.

2. OPERATION

2.1. OPERATING ENVIRONMENT

The SpiroHome

Clinic is designed for use in a clinical setting, by more than one user.

The required operation conditions for the SpiroHome

Clinic are:

Temperature: +15°C to +35°C

Relative Humidity: 10% to 85%

Pressure: 700 hPa to 1060 hPa

The SpiroHome

Clinic should only be used within the ambient temperature, relative humidity

and ambient pressure ranges given above.

Storage / Transport Environment

The required storage conditions for the SpiroHome

Clinic are:

Temperature: -20°C to +60°C

Relative Humidity: 5% to 85%

Pressure: 700 hPa to 1060 hPa

The required transport conditions for the SpiroHome

Clinic are:

Temperature: -20°C to +60°C

Relative Humidity: 10% to 85%

Pressure: 700 hPa to 1060 hPa

The SpiroHome

Clinic should not be used in the presence of flammable liquids or detergents,

nor in the presence of inflammable anaesthetic gases (oxygen or nitrogen).

The device should not be used in direct air currents (e.g. wind), sources of heat or cold, direct

sun rays or other sources of light or energy, dust, sand or any other chemical substances.

2.2. SETTING UP YOUR DEVICE

1. Download the SpiroClinic App from the App Store, Google Play Store, or Microsoft Store

into a smart device or PC.

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2. Follow the steps given in the app to create an account for a new user or login to an

existing account.

3. Remove the battery cover by sliding it,

place the batteries in the correct

orientation, slide the battery cover back to

the closed position and press on the power

button to switch the device on as shown.

4. Enable Bluetooth on the smart device or PC and pair the SpiroHome Clinic with the

smart device or PC, following the instructions on the app.

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2.3. DEVICE INDICATORS

There are 3 LED lights located on the front of

the device. The LED lights may be turned on

or flashing various colors and/or in various

patterns. The LED lights indicate the current

status of the device. Please see the following

information for guidance on LED light

indications.

LED Display

Indication/s

None of the LEDs is on.

The device is switched off.

LED indicators are consecutively flashing

green.

The device is switching on.

LED number 3 is a constant green.

The device is switched on.

LED number 2 is fading on and off in blue.

The device is connected to the app. Bluetooth®

connection has been established.

LED number 2 and LEDs 1 and 3 together are

flashing yellow in turn.

The zero flow level adjustment is setting up.

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LED number 1 is a constant blue.

The device is ready for a test.

During a test, LED number 1 is constant

yellow.

The test has timed-out (there has been no

inhalation/exhalation over a period of time)

During zero flow level adjustment LED

number 1 is constant yellow.

The zero flow level adjustment has been

unsuccessful.

All LEDs are flashing red.

There is a foreign object between the sensors.

(Check device error in troubleshooting section)

LEDs are consecutively flashing yellow.

Over-the-air connection is being established.

LED number 3 flashes red three times.

Battery low warning.

LEDs flash in reverse order and remain

switched off.

The device is switching off.

2.4. PERFORMING A LUNG FUNCTION TEST

There are several types of tests and different parameters related to lung function that can be

involved in a spirometry test. Each type of spirometry test requires a specific breathing

maneuver in order to detect the parameters related to that particular test type. However, the

general method of performing a spirometry test remains the same for all test types. Please keep

reading for more information about test types, test parameters, breathing maneuvers and

understanding the quality of test results.

2.4.1. General Method For Performing a Spirometry Test with The

SpiroHome Clinic:

1. Open the cap of the SpiroHome Clinic device.

2. Remove the Spiroway Disposable mouthpiece from its plastic packaging and insert it all

the way into the SpiroHome Clinic in the correct orientation (as shown).

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Tear the bottom part of the

mouthpiece’s plastic

package and do not touch

the mouthpiece with bare

hands.

Hold the mouthpiece with

the upper part of the

plastic package.

Insert the mouthpiece all

the way into the

SpiroHome Clinic device

in the correct orientation

3. A ‘click’ will be heard when the mouthpiece is inserted correctly all the way into the

device.

4. Open the Spirohome App on a smart device. If you are not registered, register to the

Spirohome app by creating a new user account and then log in. If the patient is not

registered, enter the patient information from the new patient section and register the

patient.

5. Select the patient name from the patient list and tap the plus button on the screen to

start the test procedure from the patient details page.

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6. The first steps will be to select test mode and enter the ambient conditions like

temperature and relative humidity (in some test modes) and then adjustment zero flow

level for the device. To perform zero flow level adjustment stabilize the device during the

zero flow level adjustment. Alternatively, place the device on a flat surface and allow the

zero flow level adjustment to be completed. Make sure that there is no airflow around the

device during the zero flow level adjustment.

7. The app will prompt the operator to start a spirometry test. Let the patient sit with his

back straight and his feet resting on the ground. The patient must place the mouthpiece

in their mouth, past their teeth (necessary for measurement accuracy) and form a tight

seal around the mouthpiece with their lips.

8. The patient should now perform the breathing maneuver related to the particular

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spirometry test. Please continue to the Type of Breathing Maneuvers section for more

information.

2.4.2. Types of Breathing Maneuvers

➢Expiration-Only (Ex-Only) Test Breathing Maneuver:

1. Ensure that the device is connected. Select the Ex-Only test mode and the test screen

will appear.

2. Read and follow the steps on the SpiroClinic application.

3. Then adjust the zero flow level for the device.

4. Patient will need to perform a forced expiratory maneuver.

a. Tidal Start On: To ready the patient, direct him/her to inhale and exhale

normally a couple of times, then ask to take a fast and deep breath, filling lungs

completely. Do not let the patient to hold breath for longer than 2 seconds.

b. Tidal Start Off: If the Tidal Start toggles off from the app settings, the patient

does not need to breathe normally several times into the mouthpiece before a

forceful expiration, and the test begins with a direct forceful expiration. When

the patient is ready, direct them to fill lungs quickly and completely with air.

5. Ask the patient to place the

mouthpiece in his/her mouth, past

his/her teeth and ensure that his/her

lips are tightly sealed around the

mouthpiece, then the patient takes a

fast and deep breath, filling his/her

lungs as much as possible. The breath

taken should not be kept for more than

2 seconds.

6. Keeping his/her lips sealed tightly around the mouthpiece, the patient must blow out the

inhaled air and empty his/her lungs as hard and fast as the patient can into the

mouthpiece and keep blowing until completely emptying his/her lungs without breaking

the seal of his/her lips.

7. If it takes more than 15 seconds to empty all the air from his/her lungs with the right

performance, the test will be completed automatically. The patient may use a nose clip to

help him/her to exhale only through his/her mouth during the forced exhalation

maneuver.

8. The patient may remove the mouthpiece from his/her mouth and resume normal

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breathing once the breathing maneuver has been completed.

9. The test results will be displayed on the app screen. Give feedback to the patient on

his/her effort by looking at the test results. The patient will need to perform 2 more tests

by repeating this breathing maneuver. However, please make sure that the patient has

time to rest between tests and feels well enough to continue.

NOTE: The difference between Tidal FVC and FVC is that the patient should breathe normally

at the beginning of the test, in Tidal FVC test mode. In FVC test mode, the data starts to be

calculated with any exhale maneuver, but in Tidal FVC mode, the data starts to be calculated

with the deep exhalation maneuver.

➢Full Loop Test Breathing Maneuver:

1. Ensure that the device is connected. Select the Full Loop test mode and the test screen

will appear.

2. Enter the required ambient conditions (makes sure you entered the correct values as the

measurement may be significantly affected by a wrong value) like temperature and

relative humidity and then adjust zero flow level for the device. To get ready, the patient

should inhale and exhale normally a couple of times.

3. Ask the patient to place the mouthpiece in his/her mouth, past his/her teeth and ensure

that his/her lips are tightly sealed around the mouthpiece, then take a slow and deep

breath, filling his/her lungs as much as possible.