Inofab Spirohome User manual

Before using your SpiroHome®Personal device and mobile application, please ensure that you

have read this user manual and all product labelling. This user manual is available digitally or

for print through the Inofab Health Apps and Inofab Health websites.

User Manual

Personal

First Pub. Date: 05.03.2018 R.11-1 / 14.10.2020

CONTENTS

1. INTRODUCTION ...............................................................................................................................................................................................................4

1.1.PRODUCT DESCRIPTION................................................................................................................................................................................................................4

1.2.WHAT’S IN THE BOX.......................................................................................................................................................................................................................4

1.3.INTENDED USE................................................................................................................................................................................................................................4

1.4.RESTRICTIONS ON USE AND CONTRAINDICATIONS..............................................................................................................................................................4

1.5.PARAMETERS....................................................................................................................................................................................................................................5

2. OPERATION...........................................................................................................................................................................................................................6

2.1.STORAGE AND OPERATING ENVIRONMENT............................................................................................................................................................................6

2.2.SETTING UP YOUR DEVICE............................................................................................................................................................................................................6

2.3.DEVICE INDICATORS......................................................................................................................................................................................................................7

2.4.SPIROMETRY MEASUREMENT.......................................................................................................................................................................................................8

2.5.UNDERSTANDING THE TEST QUALITY.......................................................................................................................................................................................10

2.6.SIGNS AND SYMBOLS.................................................................................................................................................................................................................13

2.7.TECHNICAL FEATURES..................................................................................................................................................................................................................13

2.8.SAFETY WARNINGS AND PRECAUTIONS................................................................................................................................................................................14

3.MAINTENANCE..................................................................................................................................................................................................................15

3.1.CLEANING AND DISINFECTION................................................................................................................................................................................................15

3.2.CLEANING THE SPIROWAY®REUSABLE....................................................................................................................................................................................16

3.3.BATTERIES.......................................................................................................................................................................................................................................16

3.4.DISPOSAL OF SPIROHOME®.......................................................................................................................................................................................................17

4.TROUBLESHOOTING..................................................................................................................................................................................................17

5.ORDERABLE ACCESSORIES...................................................................................................................................................................................18

6.TERMS OF WARRANTY.............................................................................................................................................................................................18

7.ELECTROMAGNETIC COMPATIBILITY.........................................................................................................................................................19

8.MANUFACTURER INFORMATION...............................................................................................................................................................23

1.INTRODUCTION

1.1. PRODUCT DESCRIPTION

The SpiroHome®Personal is a portable

spirometer that pairs (via Bluetooth®) with smart

devices running iOS or Android SpiroHome

Personal®applications. The SpiroHome®

Personal measures and displays information

about the user’s lung function. The user performs

a spirometry test with the device as described

in the “Spirometry Measurement” section

of this user manual. The ultrasonic sensors

within the SpiroHome®Personal detect the

volume and speed of air moving through the

device and display this as spirometric data

on the SpiroHome®Personal app. The app

guides the user throughout the test session. The

SpiroHome®Personal app can be downloaded

from GooglePlay or App Store. The device

is powered by standard 2 x AAA Alkaline

batteries. SpiroHome®Personal is used with the

SpiroWay®Reusable mouthpiece.

1.2. WHAT’S IN THE BOX

The SpiroHome®Personal box contains:

• SpiroHome®Personal device (b)

• SpiroWay®Reusable mouthpiece (a)

• SpiroHome®Personal Cap©

• User Manual

• Carrying pouch (d)

CAUTION: Please check that there is no

visible damage on any device components. If any

damage is present, do not use or attempt to repair

the device but contact the manufacturer directly.

1.3. INTENDED USE

The SpiroHome®Personal is intended to be used

as a portable spirometer in the lung function

testing of:

• children (over the age of 5) and adults who

may have a chronic pulmonary disease

including, but not limited to, asthma, chronic

obstructive pulmonary disease and cystic

ﬁbrosis.

NOTE:A competent adult should assist

patients (children or older patients) who may

need assistance.

1.4. RESTRICTIONS ON USE AND

CONTRAINDICATIONS

Diagnosis of medical conditions or prescription

of treatments can only be made by a qualiﬁed

healthcare professional who may use results

obtained with the SpiroHome®Personal as adjunct

information when performing a full medical

examination that has taken into consideration your

clinical history and other test results.

SpiroHome®Personal is a single-user device and

is to be used by a single user. If the device will be

used by a new user, ensure that the data of the

previous user is erased from the device memory,

their account is removed from the app and a new

user account is created for the new user. The device

must also be cleaned and disinfected according to

the information given in this user manual before use

by a new user.

A SpiroWay®Reusable mouthpiece must not be

shared between users, including family members.

A new mouthpiece must be used for a new user.

Spirometry tests should only be performed if you

are not experiencing any shortness of breath,

are in good health and capable of performing a

lung function test. Test results may otherwise be

unreliable.

Failure to perform the required breathing maneuver

correctly during a test may lead to inaccurate and

unacceptable results. More information about how

to perform a spirometry test correctly is described

in this user manual. The device should not be used

if test accuracy and/or reliability is jeopardized by

these or other external factors.

Spirometry tests 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 if you have 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

Table 1: Parameters & Deﬁnitions

Parameters Deﬁnition

FVC (L)

Forced Vital Capacity — The volume of

air that can forcibly be blown out after

full inspiration

FEV0.75(L)

Forced Expiratory Volume after 0.75

seconds: The volume of air that can

forcibly be blown out in 0.75 seconds,

after full inspiration.

FEV1 (L) Forced Expiratory Volume within

1 second

FEV6 (L) Forced Expiratory Volume within

6 seconds

FEV0.75/FVC The ratio of FEV0.75 to FVC

FEV1/FVC The ratio of FEV1to FVC

PEF( L/s)

Peak Expiratory Flow — The maximal

ﬂow rate achieved during the maxi-

mally forced expiration initiated at full

inspiration.

FEF25-75( L/s)

Forced Expiratory Flow from 25% to

75% of vital capacity — synonymous

with MMEF

FEV1/FEV6The ratio of FEV1to FEV6

FET(s) Forced Expiratory Time

BEV(L) Back extrapolated volume

The recommended number of trials per spirometry

session is 3, however, you may perform up to 8

trials. The best values obtained from the spirometry

trials performed in one session are displayed on

the app. You also have the option to view each

individual trial result of a spirometry session.

The device provides a reference value. This is

calculated from large epidemiological studies

and requires your height, weight, age, sex and

ethnicity information. Your results are compared to

the reference values as a percent predictive value

indicator of your respiratory health. Your personal

best value for a spirometry trial can be discussed

and with your healthcare provider for medical

interpretation.

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 spirometry.

risks associated with testing should always

be weighed against the beneﬁt of obtaining

information about lung function. Spirometry

should be discontinued if you experience pain

during the maneuver. If you have any of these

potential contraindications please seek spirometry

testing in primary care settings or pulmonary

function laboratories where you will be under the

supervision of healthcare professionals and there

may be access to emergency care if needed.

Relative Contraindications for Spirometry;

Due to increases in myocardial demand or

changes in blood pressure;

•Acute myocardial infarction within 1 week

•Systemic hypotension or severe hypertension

•Signiﬁcant atrial/ventricular arrhythmia

•Uncompensated 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 weeks

•Recent concussion with continuing symptoms

•Eye surgery within 1 week

Due to increases in sinus and middle ear pressures;

•Sinus surgery or middle ear surgery or

infection within 1 week

Due to increases in intrathoracic and intra-

abdominal pressure;

•Presence of pneumothorax

•Thoracic surgery within 4 weeks

•Abdominal surgery within 4 weeks

•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

If you have or suspect having any of the conditions

above, consult your healthcare professional

before using the SpiroHome®Personal.

1.5. PARAMETERS

The SpiroHome®Personal records and displays

the following spirometric data:

Enable Bluetooth®on your smart device

and pair the SpiroHome®Personal

with your smart device by following the

instructions on the app.

Create Account

2.2. SETTING UP YOUR DEVICE

Download the SpiroHome®Personal

app from the App Store or Google Play

Store into your smart device.

Follow the steps given in the app to

create an account as a new user or

Slide open the battery cover, insert the AAA alkaline

batteries in the correct orientation, slide the battery

cover back to the closed position and press the power

button for 1 second to switch on the device as shown.

2. OPERATION

2.1. STORAGE AND OPERATING

ENVIRONMENT

The SpiroHome®Personal is intended to

be used in home settings. It is not intended

for use in clinical settings such as hospitals

or private clinics.

The operating conditions for the

SpiroHome®Personal are:

•Temperature: +15°C to +35°C

•Relative Humidity: 10% to 85%

The storage conditions for the

SpiroHome®Personal are:

•Temperature: -20°C to +60°C

•Relative Humidity: 0% to 85%

•Pressure: 500 hPa to 1060 hPa

The SpiroHome®Personal should not

be used in the presence of inﬂammable

liquids or detergents, nor in the presence

of inﬂammable anesthetic 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.

2.3. 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 in various patterns.

The LED lights indicate the current status of the

device. Please see the following information

for guidance on LED light indications.

Table 2: Device Led Indicators

LED Display Indication/s

None of the LEDs are on The device is switched off

LED indicators are consecutively ﬂashing green The device is switching on

LED number 3 is constantly ﬂashing green The device is switched on

LED number 2 is fading 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.

LED number 1 is constantly blue. The device is ready for a test.

During a test, LED number 1 is constantly yellow. The test has timed-out (there has been no inhala-

tion/exhalation over a while)

During zero ﬂow level adjustment setup LED

number 1 is constantly yellow.

The zero ﬂow level adjustment setup 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. SPIROMETRY MEASUREMENT

Follow the instructions that

appear on the screen. The ﬁrst

step will be to record a zero

ﬂow level adjustment for the

device. You will need to leave

the device on a ﬂat surface for

this process to be completed.

Sit upright with your back straight

and your feet ﬂat on the ground.

Remove the SpiroWay®Reusable

mouthpiece from its plastic

packaging and insert it all

the way into the SpiroHome®

Personal in the correct orientation

(as shown). You will hear a click

when the mouthpiece is fully

inserted into the device.

Open the SpiroHome®App

on your smart device and

make sure you are signed in.

Tap the ‘+’ button to start the

test procedure.

Setting Up

Your Device

1 2 3 4

Place the mouthpiece in your

mouth, past your teeth, and

form a tight seal around the

mouthpiece with your lips.

5 6 7 8

You will now need to perform

a forced expiratory maneuver.

To ready yourself, inhale and

exhale normally a couple of

times, then take a fast and

deep breath, ﬁlling your lungs

completely. Do not hold breath

for longer than 2 seconds.

Without hesitation and with your lips

sealed tightly around the mouthpiece

blow out the air in your lungs as hard

and fast as you can. Keep blowing

until you feel like you have completely

emptied your lungs. You may use

a nose clip at the beginning of the

procedure to ensure that you are

exhaling only through your mouth.

Repeat these steps for

each successive trial,

ensuring that you rest

for at least 20 seconds

between each trial.

After completing your

spirometry session, switch

off the device by pressing

the power key. Use the cap

to protect the mouthpiece

from contamination when

the device is not in use.

IMPORTANT:This procedure describes how

to perform the forced expiratory maneuver when

‘Tidal Mode’ is selected on the SpiroHome®

application.

‘Tidal Mode’ requires you to breathe normally

several times into the mouthpiece at the beginning

of the test before a forceful expiration is

performed.

If you deselect ‘Tidal Mode’ from the app settings,

you do not need to breathe normally several times

into the mouthpiece at the beginning of the before

a forceful expiration, and the test begins with a

direct forceful expiration.

2.4.1. End of Forced Expiration (EOFE)

The end of a forced expiratory maneuver is

referred to as ‘End of Forced Expiration’ or ‘EOFE’.

The EOFE is important in recognizing when a true

FVC measurement has been achieved. Any of the

following three cases will indicate an EOFE:

1.Expiratory plateau (≤0.025 L in the last 1 s of

expiration)

2.Expiratory time ≥15 s

3.FVC is within the repeatability tolerance of or is

greater than the largest prior observed FVC *

*More information in section 2.5

Table 3: Summary of Acceptability, Usability, and Repeatability Criteria for FEV1and FVC

Acceptability and Usability Criterion

Required for

Acceptability

Required for

Usability

FEV1FVC FEV1FVC

Must have BEV ≤5% of FVC or 0.100 L, whichever is greater Yes Yes Ye s Yes

Must have no evidence of a faulty zero-ﬂow setting Yes Yes Ye s Yes

Must have no cough in the ﬁrst second of expiration Yes No Ye s No

Must have no glottic closure in the ﬁrst second of expiration* Yes Yes Ye s Yes

Must have no glottic closure after 1 s of expiration No Yes No No

2.5. UNDERSTANDING THE TEST QUALITY

After each test session, the quality of your test will be graded based on how well you performed the breathing maneuver and whether your results are

acceptable, usable or neither. This grading relates to the consistency of your blows, not the health of your lungs.

The American Thoracic Society (ATS) and European Respiratory Society (ERS) grade FVC and FEV1parameters in children and adults as given in the table 3;

EOFE = end of forced expiration

Must achieve one of these three EOFE indicators:

1. Expiratory plateau (≤0.025 L in the last 1 s of expiration)

2. Expiratory time ≥15 s

3. FVC is within the repeatability tolerance of or is greater than the largest prior observed FVC *

No Yes No No

Must have no evidence of obstructed mouthpiece or spiromete Yes Yes No No

Must have no evidence of a leak Yes Yes No No

If the maximal inspiration after EOFE is greater than FVC, then

(FIVC — FVC) must be ≤0.100 L or 5% of FVC, whichever is greater ** Ye s Yes No No

Repeatability criteria (applied to acceptable FVC and FEV1values)

Age > 6 yr: The difference between the two largest FVC values must be ≤0.150 L, and the difference between the two largest FEV1values must be ≤0.150 L

Age ≤ 6 yr: The difference between the two largest FVC values must be ≤0.100 L or 10% of the highest value, whichever is greater, and the difference between

the two largest FEV1values must be ≤0.100 L or 10% of the highest value, whichever is greater

* Occurs when the patient cannot expire long enough to achieve a plateau (e.g., children with high elastic recoil or patients with restrictive lung disease) or when

the patient inspires or comes off the mouthpiece before a plateau. For within-maneuver acceptability, the FVC must be greater than or within the repeatability

tolerance of the largest FVC observed before this maneuver within the current prebronchodilator or the current post-bronchodilator testing set.

** This criterion is not used, as there is no parameter calculated using the inspiration maneuver in SpiroHome®Personal.

Although the performance of a maximal forced inspiration is strongly recommended, its absence does not preclude a maneuver from being judged acceptable,

unless the extrathoracic obstruction is speciﬁcally being investigated.

Table 4: Grading System for FEV1and FVC (Graded Separately)

Grade Number of Measurements Repeatability:

Age >6 yr

Repeatability:

Age ≤6 yr *

A ≥ 3 acceptable Within 0.150 L Within 0.100 L *

B 2 acceptable Within 0.150 L Within 0.100 L *

C ≥ 2 acceptable Within 0.200 L Within 0.150 L *

D ≥ 2 acceptable Within 0.250 L Within 0.200 L *

≥ 2 acceptable > 0.250 L > 0.200 L *

OR 1 acceptable NA NA

U 0 acceptable AND ≥ 1 usable NA NA

F 0 acceptable and 0 usable NA NA

* Or 10% of the highest value, whichever is greater; applies for age 6 years or younger only.

NA: Not Applicable

2.6. SIGNS AND SYMBOLS

The following signs and symbols are provided for the safe use and storage of your

SpiroHome®Personal. 2.7. TECHNICAL FEATURES

Table 5: Markings & Descriptions

Markings Descriptions Markings Descriptions

“Manufacturer”

This symbol accompanied by the name

and the address of the manufacturer

adjacent to the symbol

Single-use only

Sign of Conformity Type BF of Medical Electrical

Equipment

Disposal in Compliance with WEEE Serial Number

Temperature Limit Lot Number

Humidity Limit Ref Number

Atmospheric pressure limitation IP IP Number

Do not use if the package is damaged The device includes RF

transmitters

Keep away from sunlight The instruction manual/

booklet must be read.

Keep dry Caution

Explanatory information

Table 6: Technical Features

Flow / Volume measurement

method

Ultrasonic transducer

measurement

Power Supply 2 x 1.5V AAA

Alkaline batteries

Dimensions 110 x 63 x 41 mm

Weight (With batteries) 90 g

Weight (Without batteries) 67 g

Flow range 0 - 14 L/s

Maximum volume measured 10 L

Volume accuracy (Average) 2.00 %

Dynamic resistance at 14 L/s 86 Pa*s/L

Volume resolution 1 mL

Flow resolution 1 mL/s

Medical device class Class IIA

Wireless connection BLE 4.2

2.8. SAFETY WARNINGS AND

PRECAUTIONS

IMPORTANT:Please adhere to all safety

warnings, precautions and recommendations

given in this user manual as failure to comply may

result in measurement errors, display of incorrect

results or possible harm to the device or the

user. The manufacturer is not responsible for any

damage or harm to the device or user that is the

direct result of non-compliance to these warnings

and precautions other instructional materials

provided with the device.

•If any damage is present on the device or its

components upon initial unboxing of the product

then do not use the device and return it to the

supplier.

•Do not use this SpiroHome®Personal for any

other purpose than its intended use.

•Competent adults assisting pediatric, elderly or

differently-abled users should inform them about

the safety warning and precautions given in this

user manual before the use of the device.

•Regardless of the data presented on the

SpiroHome® Personal, if you feel unwell or have

respiratory distress symptoms cease device use

and contact your healthcare provider immediately.

•If there is an excessive decrease in your FEV1

value then cease use of the device and inform your

healthcare provider.

•Do not perform more than 8 spirometry trials

in one spirometry session. If you experience pain

during the maneuver, cease device use and rest.

•Maximal inﬂation is unnatural and if you have

not achieved it before it may seem somewhat

uncomfortable. If you feel sensations of dizziness

or giddiness during pulmonary function sessions,

then cease device use and inform your healthcare

provider.

•Do not walk or run whilst performing a lung

function test with the SpiroHome®Personal.

•Do not perform a spirometry test with food or

objects in your oral cavity as this may lead to risk

of choking.

•Do not share your SpiroHome®Personal with

any other users, including family members. The

SpiroHome®Personal and SpiroWay®Reusable is

to be used by a SINGLE user only.

•If the device is to be used by a new user:

Clean and disinfect device and cap according to

instructions in the Maintenance section of this user

manual AND use a new mouthpiece for the new

user AND create a new account for the new user

on the SpiroHome®Personal app.

•To prevent damage to the device due to battery

leakage or oxidation, remove all batteries if the

SpiroHome®device is not to be used or is to be

stored for a long time.

•Dispose of the device and/or the device

batteries responsibly as required by local

legislation.

•Check the device and components for foreign

bodies or surface impurities before each use as this

could lead to inaccuracies in test measurements.

Coughing or spitting into the device may cause

incorrect readings.

•Do not expose the device to liquids, prevent any

liquids from entering the device. In the event of a

liquid spill on or around the device, immediately

remove batteries and let the device dry thoroughly

before use.

•If you experience any adverse events using the

device, report immediately to your healthcare

provider and local authorities as required by

local legislation. Please seek to also report such

incidents to the manufacturer.

•Do not use the SpiroHome®Personal with a

charging smart device. Make sure the smart device

is unplugged from its charger before conducting a

spirometry test.

•Use only original accessories speciﬁed and

provided by the manufacturer. Accessories that

are not original will cause inaccurate readings, or

harm to the user and/or device.

•Do not hold the mouthpiece from the ﬁlters

located on the mouthpiece. Do not use the

mouthpiece if these ﬁlters have been physically

compromised.

•Store and operate the device only as

speciﬁed in this user manual (see Section 3.1)

to avoid device malfunction and/or incorrect

measurements.

•Do not use the device in the presence of strong

electromagnetic sources, such as electrosurgical

equipment, or the presence of computed

tomography (CT) equipment.

•Do not attempt to repair, modify or reconﬁgure

the device. Contact the manufacturer/distributor/

retailer directly if your SpiroHome®Personal is

damaged or malfunctioning or you encounter

data that you cannot make sense of. Unauthorised

repairs, modiﬁcations or reconﬁgurations of the

device will void the warranty of the product.

•Follow all data security warnings and

recommendations for your personal smart

device as per it’s manufacturer’s instructions to

protect your personal data.

•Do not share your SpiroHome®account

information with unauthorized parties.

•The SpiroHome®Personal conforms to EN

60601-1, EN 60601-1-11, EN 60601-1-2 and

EN 300 328. As this device operates with RF

technology, it must be used as only speciﬁed by

the manufacturer to avoid interference by radio

communications.

3. MAINTENANCE

Handle your SpiroHome®Personal and

SpiroWay®Reusable mouthpiece with care.

Store the SpiroHome®Personal and

SpiroWay®Reusable in dust/dirt- and

moisture-free conditions. You may utilize the

pouch provided with the product to device and

components.

Before each use, always check that the device

and components are free from contaminants

and do not have any visible damage.

NOTE: One ‘use’ of the spirometer is

deﬁned as one complete spirometric testing

session (can include up to 8 individual

successive spirometry trials).

The SpiroHome®Personal does not require

routine calibration as it uses ultrasonic ﬂow

measurement technology. If you suspect a

problem with the calibration of the device, cease

use and contact the manufacturer immediately.

3.1. CLEANING AND DISINFECTION

You should clean the SpiroHome®Personal body and cap at least once a week or whenever the device

is visibly contaminated. You must perform the cleaning step before performing the disinfection step.

Regular cleaning will prevent the physical buildup of contaminants on device surfaces. Disinfection kills

and destroys pathogens such as bacteria, viruses, or other microorganisms which might still be present on

device surfaces after initial cleaning.

Wash Hands

Before beginning the

procedure, wash hands

thoroughly with soap

and water.

Wash Hands

Wash hands thoroughly after

performing a cleaning or

disinfection procedure, and

before handling the cleaned or

disinfected components again

for packing and storage.

Perform disinfection

To disinfect the device and cap use a new high-level

disinfectant (Sodium Hypochlorite <0.6%, Sodium

hydroxide <0.02%, Sodium Chloride <4%)

wipe to wipe over all accessible surfaces again

using moderate pressure and for the contact time

recommended by the wipe manufacturer.

Medipal®Chlorine Disinfectant wipes (Pal

International Ltd.) are high-level disinfectant

(Sodium Hypochlorite <0.6%, Sodium hydroxide

<0.02%, Sodium Chloride <4%) wipes suitable for

cleaning and disinfecting SpiroHome®devices and

is available at;

https://www.palinternational.com/en/healthcare/

wipe-products/chlorine-disinfectant-wipes/

Perform cleaning

First, remove the SpiroWay®Reusable from the

SpiroHome®Personal device. Using a high-level

disinfectant (Sodium Hypochlorite <0.6%, Sodium

hydroxide <0.02%, Sodium Chloride <4%) wipe,

wipe all accessible surfaces of the device and cap

using moderate pressure for at least 30 seconds to

remove contaminants. Be gentle and use care when

wiping the sensors to avoid damaging them.

Wipe all accessible surfaces of the device and cap,

using moderate pressure, as shown.

CAUTION: Prevent any excess liquids contained

within the wipes from entering the components of the

SpiroHome®Personal. Never immerse the product

in water or any other liquid solution.

3.2. CLEANING THE SPIROWAY®

REUSABLE

To clean the SpiroWay® Reusable mouthpiece

once a week and whenever visibly soiled;

•Add dishwashing detergent (e.g. those

containing 5-15% anionic surfactant, 5%

nonionic surfactant) to warm water to create

a soapy solution.

•Shake the mouthpiece gently in the soapy

solution.

•Hold the mouthpiece under running tap

water to rinse, do not rub

•Leave the mouthpiece upright on a clean

lint-free cloth at room temperature until it is

completely dry.

CAUTION: Do not insert the SpiroWay®

Reusable mouthpiece into your SpiroHome®

Personal device until it is completely dry

The SpiroWay® Reusable should be replaced

every 3 months. The SpiroWay® Reusable

mouthpiece must be replaced if you used or

suspect having used the mouthpiece whilst

having a bacterial or viral infection. Replace

the SpiroWay® Reusable immediately if the

ﬁlters are damaged or whenever a risk of

contamination is suspected.

CAUTION:

Risk of Cross-Contamination

The SpiroWay® Reusable mouthpiece is

indicated for single-patient-use only to prevent

any potential of cross-contamination. Thorough

cleaning and disinfection of the device must be

performed prior to use by a new user. A new

mouthpiece must be used by the new user.

To purchase new mouthpieces, contact

authorized local distributors or, if there is no

local distributor, contact Inofab Health at

www.inofab.health

3.3.BATTERIES

The SpiroHome® device operates with 1.5V

AAA Alkaline batteries. The battery life of the

SpiroHome® is approximately 12-18 months,

assuming daily use of the device. The battery

charge level is continuously monitored by the

device. The device will not turn on if the battery

charge level is low and will make a beeping

sound to notify you.

WARNING: The batteries of the device

should be removed if the device is not going to

be used for more than a month.

Instructions for battery

replacement

Remove cap and

SpiroWay®Reusable

mouthpiece from

the device.

Slide battery cover

to open position.

Remove the empty batteries.

Insert new batteries in the

correct orientation.

Slide the battery

cover back to the

closed position.

Insert the SpiroWay®

Reusable mouthpiece in the

correct orientation. Your

device is now ready to use.

Place cap on device

to protect mouthpiece

from contamination

during storage.

4. TROUBLESHOOTING

Table 7: Troubleshooting

Problem Cause Solution

Device not turning on Multiple possible causes

Check battery orientation and correct polarities

Remove the AAA batteries, wait 30 seconds and reinstall AAA batteries

Replace AAA batteries

Check that battery cap is in the lock position, or if the cap is broken, contact manufacturer

SpiroHome®cannot connect to a

smart device via Bluetooth®

The smart device is out of range Bring your smart device closer to the SpiroHome®device

Smart device Bluetooth®is disabled Enable Bluetooth®on your smart device

Bluetooth®connection not working

properly

Your smart device will need Bluetooth®version 4.0 or higher. Find and select SpiroHome®

Personal from the list of detected devices

Test results are inconsistent

SpiroWay®mouthpiece is dirty Clean SpiroWay®to ensure that the lumen is not obstructed or replace with a new

mouthpiece

SpiroWay®mouthpiece is damaged Replace SpiroWay®

SpiroWay®mouthpiece is installed

incorrectly Refer to the user manual for proper installation of SpiroWay®

Spirometry test was performed incorrectly Refer to “Spirometry Measurement” in the user manual or refer video tutorial on app

The test does not start - Cannot set

up zero ﬂow level adjustment Direct air current in the environment

Close the cap of the SpiroHome®to avoid effects of environmental ﬂow

Place the device on a ﬂat surface

Remove causes of direct air current e.g. air conditioner, opened window, fan, etc.

The test does not start - balloon

animation is not moving Multiple possible causes

Quit test and start a new test

Quit the application and start a new test

Switch the device off and turn on again to reset

Test starts before you start blowing Rough handling of the device Keep the device as stable as possible after starting a test

3.4. DISPOSAL OF SPIROHOME®

This product is not to be discarded as regular household waste and should be discarded as electronic waste in accordance with local regulations and

returned to a collection point of recycling for electric and electronic devices.

Used batteries should be disposed of in designated battery recycling containers in accordance with local laws and regulations.

Table 7: Troubleshooting

Device disconnected during test

The device is turned off accidentally or due

to rough handling during use Switch the device on again and proceed with a new test

Bluetooth®connection disrupted Reconnect the device and proceed with a new test

Test quality grade always low Not performing the test correctly Repeat the test following the rules and conditions speciﬁed in the “Spirometry Measurement”

section of this user manual

Measurement error screen

showed up

Flow limit exceeded This device is intended to measure 0-14 L/s.

SpiroWay®mouthpiece is dirty Clean SpiroWay®to ensure that the lumen is not obstructed or replace SpiroWay®

SpiroWay®mouthpiece is damaged Replace SpiroWay®

Device malfunction Contact manufacturer

Device error screen showed up

SpiroWay®mouthpiece is installed

incorrectly

Refer to the user manual for proper installation of SpiroWay®

There is a foreign object between the

sensors.

Check SpiroHome®device lumen and clean if necessary

SpiroWay®mouthpiece is dirty Clean SpiroWay®to ensure that the lumen is not obstructed or replace with a new

mouthpiece

SpiroWay®mouthpiece is damaged Replace SpiroWay®

For any other technical queries please call customer service on +90 312 988 03 08 or e-mail at [email protected]

5.ORDERABLE ACCESSORIES

•SpiroWay®Reusable Mouthpiece

(Reference number: 03000)

•SpiroHome®Personal Cap

(Reference number: 01104)

•SpiroHome®Pouch

(Reference number: 01509)

To purchase these accessories please contact

your local distributors or İnofab Health at

www.inofab.health

6. TERMS OF WARRANTY

SpiroHome®Personal, together with any

accessories provided, is guaranteed for 24

months, effective from the date of purchase, upon

the provision of an invoice or sales receipt. The

service life of the product is 5 years, effective from

the date of purchase.

The user is responsible for checking the product

for damage or missing components at the time

of purchase or delivery, and any claims must be

made in writing to the manufacturer.

The customer must return goods for replacement or

repair at the customer’s expense to the authorized

supplier or manufacturer. The product must be

returned with a clear written explanation of the

fault or problem.

This warranty does not apply, at the discretion of

the manufacturer, in the following cases:

•Improper installation or operation of the

device.

•Use of the product for purposes other than

those speciﬁed in this user manual.

•Damage due to failure to follow instructions.

(Continuation of page17)

•Damage due to unauthorized repair, modiﬁcation or reconﬁguration performed on the device.

•Damage caused by falls, hits, lack of proper care or maintenance.

•Damage caused by abnormal physical or electrical stress or defects of the electric supply (battery cell) or of equipment.

•If the serial number is altered, deleted, removed or rendered illegible.

Table 8: Emission table for IEC 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic emissions

SpiroHome®battery-operated spirometer devices are intended for use in the electromagnetic environment speciﬁed below. Users of these devices should assure

that it is used in such an environment.

Emission Test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

Class B

The SpiroHome®battery-operated devices use RF

energy only for its internal function. Therefore, its RF

emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

Harmonic emissions

IEC 61000-3-2 Not applicable Emissions are not applicable because SpiroHome®

does not connect to mains supply but operates with

AAA batteries.

Voltage ﬂuctuations / ﬂicker emissions IEC

61000-3-3 Not applicable

7.ELECTROMAGNETIC COMPATIBILITY

Meeting the requirements for EMC (electromagnetic compatibility) and preventing the unsafe use of the device, medical devices including SpiroHome®

manufactured by Inofab Health Technologies conform to the EN60601-1-2 standard which deﬁnes the levels of immunity to electromagnetic interference

as well as maximum levels of electromagnetic emissions for medical devices.

•For details, please see the following tables:

Table 9: Immunity (Stimulation mode) table according to IEC 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic immunity

SpiroHome®battery-operated spirometer devices are intended for use in the electromagnetic environment speciﬁed below. Users of these devices should assure

that it is used in such an environment.