HealthUp AioCare User manual

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AioCare Spirometry System User Manual
- system for remote monitoring, with a spirometer, peak flow meter and pulse meter module
Manufacturer:
HealthUp sp. z o.o.
ul. Smolna 4, 00-375 Warsaw, Poland
Telephone: [phone], e-mail: [email protected]
© Copyright HealthUp
Current edition (revision 2.1 of 03/10/2017)

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Table of contents
1. Description of AioCare system..............................................................................................................3
1.1. Contraindications for spirometry testing...........................................................................................4
1.2. Contraindications for peak flow measurement................................................................................4
2. Structure of AioCare spirometry system.............................................................................................. 4
2.1 Measuring module combined with mobile device............................................................................5
2.1.1 Operating conditions and device class .................................................................................. 5
2.1.2 Technical data............................................................................................................................5
2.1.3 Schematic structure of AioCare .............................................................................................. 6
2.1.4 AioCare assemblies.................................................................................................................. 6
3. Testing...................................................................................................................................................... 6
3.1 Calibration of the spirometry system.................................................................................................. 6
3.2. Flow-volume loop.................................................................................................................................7
3.3. Spirometry............................................................................................................................................. 7
3.4. Flow reset..............................................................................................................................................7
4. Conducting testing.................................................................................................................................. 7
4.1 Preparing AioCare for operation......................................................................................................... 7
4.2 Communication between AioCare device and user........................................................................ 8
4.3 Hardware and software requirements for the mobile device......................................................... 9
4.4. First launch of application...................................................................................................................9
4.5 Log in...................................................................................................................................................... 8
4.6 Main screen ...........................................................................................................................................9
4.6. Conducting a test...............................................................................................................................10
4.7 Measurement results..........................................................................................................................11
5. AioCare spirometer maintenance.......................................................................................................12
5.1 Operation guidance............................................................................................................................12
6. Meaning of symbols used by the manufacturer...............................................................................13
7. Maintenance ..........................................................................................................................................15
7.1. Operation of AioCare power supply................................................................................................15
7.2. Battery charger...........................................................................................................................15
7.2.1. Battery replacement...............................................................................................................16
8. Disposal..................................................................................................................................................16
9. Warranty.................................................................................................................................................16
10. Defects and malfunction....................................................................................................................16

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1. Description of AioCare system
AioCare has been developed at Healthup by a team of experts with practical experience in design and
manufacture of medical devices and software development.
The main innovation of our system is a unique combination of measurement sensors, our proprietary
measurement channel, and a functional application working on iOS and Android operating systems.
AioCare –remote monitoring system with the spirometer module, used for conducting spirometry. These
are basic tests for conducting functional diagnostics and assessment of mechanical properties of the
respiratory system. It allows the user to record the spirogram and assess breathing manoeuvre of forced
expiration/inspiration, and the maximum flow-volume loop/volume-time curve, and the values related to
them, such as forced vital capacity (FVC). In addition, you can record spirograms following bronchodilation.
These measurements are used in diagnostics and monitoring of lung conditions and intervention during the
treatment for certain types of respiratory diseases. The spirometer has been designed for use by technicians
and physicians conducting respiratory tests, but may be also used by patients for self-monitoring, provided
that they understand the test instructions. Standard values and interpretation results have not been
calculated for children less than 5 years old.
AioCare also works as a peak flow meter, measuring peak expiratory flow (PEF).
INTENDED PURPOSE:
1. Diagnostics of respiratory diseases in patients of all ages except for neonates and infants as part
of out-patient and in-patient care:
2. Respiratory system function assessment in the presence of:
a. signs (dyspnoea, wheezing, coughing, expectorating, orthopnoea, pain in the chest),
b. symptoms (abnormal breathing sounds, features of emphysema, prolonged expiration
phase, cyanosis, deformations of the rib cage, nail clubbing)
c. abnormal additional tests (abnormal x-ray of the lungs, hypoxemia, hypercapnia,
polyglobulia –increased values of haematocrit)
3. Screening tests in persons with risk factors (smoking, exposure to toxic factors, dusts, gases).
4. Examination of the respiratory system in systemic conditions
5. Assessment of risk in the perioperative period:
a. extrapulmonary surgeries
b. thoracic surgeries
6. Assessment of the respiratory function prior to strenuous physical activity.
7. Monitoring of respiratory diseases in patients of all ages except for neonates and infants as part of
out-patient and in-patient care:
a. Monitoring of treatment with:
obronchodilators,
ocorticosteroids (asthma, COPD, interstitial lung diseases),
oother medicines (e.g. antibiotic therapy in cystic fibrosis),
odiuretics in congestive heart failure
b. Objective assessment of the course of disease and impact of illnesses on the respiratory
function.
c. Monitoring of the effects of treatment known to have damaging action on the respiratory
tract.
d. Monitoring of the respiratory function in patients following transplantation of the lungs and
other organs (kidneys, bone marrow –GVH, BOOP).
e. Monitoring of the respiratory function in individuals exposed to toxic agents at the
workplace.
8. Self-monitoring of the respiratory function by the patient in home environment:
a. signs and symptoms (dyspnoea, wheezing)
b. exacerbations of respiratory diseases, including asthma, chronic obstructive pulmonary
disease

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c. following lung transplantation
1.1 Contraindications for spirometry testing
1. Absolute contraindications:
•recent (in the hospitalisation period) myocardial infarction,
•recent (in the hospitalisation period) cerebral stroke,
•aneurysms (risk of aneurysm rupture and bleeding after increased pressure in the chest),
•recent ophthalmic surgery (e.g. cataract surgery),
•increased intracranial pressure,
•haemoptysis of unknown aetiology,
•pneumothorax.
2. Relative contraindications:
•a condition that may affect the results (e.g. nausea, vomiting, persistent coughing),
•a condition following abdominal,
•or thoracic surgery (post-operative pain precluding correct breathing manoeuvres during the test),
•dizziness, arrhythmias,
•significant desaturation after interruption of oxygen therapy for the duration of the test.
1.2. Contraindications for peak flow measurement
No contraindications for peak flow measurement.
2. Structure of AioCare spirometry system
AioCare is a portable spirometer for the testing of the respiratory function. AioCare spirometry system
comprises:
•measuring module with a flow tube
•mobile application for installation from AppStore or Google Play
Equipment:
•bacterial filter –the use-by date is indicated on the welded film of the packaging, don’t use after
expiry
•nose clip –the use-by date is indicated on the welded film of the packaging, don’t use after expiry
•USB cable
•abbreviated instructions for use
The spirometry system is capable of:
1. Testing:
a. spirometry (parameters: FVC, FEV1, PEF, Tiffeneau, FEF25, FEF50, FEF75, VPTEF_VE,
TPTEF_TE)
b. peak flow measurement (PEF)
2. Archiving of testing results in the application.
3. Creating patient’s personal file.

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2.1 Measuring module combined with mobile device
The purpose of the measurement module is to transform the patient’s inhalation and exhalation parameters
into electric signal. The signal generated in the module is processed by the spirometer’s microcontroller and
sent through Bluetooth 4.0 to the mobile application where the data are processed into graphs and numeric
values of parameters displayed on the screen of a mobile device.
2.1.1 Operating conditions and device class
Optimum ambient temperature for measurement: +15 to +40 °C
Relative humidity: 30-75%
Storage: from +5°C to +45°C
Internally powered device
BF applicator
Product class II A
The device operating conditions mentioned above make it suitable for operation in home conditions and in
professional health care facilities: diagnostic surgeries, general clinics.
2.1.2 Technical data.
Type of sensor for flow measurement
Thermal
Tests
Pre- and post- FVC (bronchodilator)
Range of spirometry flow rate measurement
0-16 L/s
Linearity
3% (0.4L and 0.6L)
Flow rate measurement resolution
measured 5 mL/s, used 10 mL/s
Reliability/reproducibility
Meets or is better than the ATS 2005 standard
(0.05 L or 3% from the readout, whichever is
larger)
Automatic BTPS conversion
in-built measurement sensors: air temperature,
pressure and humidity
Determination of t0
Algorithmic
Expiratory lung impedance
˂0.15 kPa/(L/s) with flow rate 14L/s
Dynamic flow resistance
˂0.5 cm H2O/L/s
Protection of enclosure against moisture ingress,
acc. to IEC 60529 (elements of the spirometer)
IP 22
Measurement frequency
100 Hz
Internal power supply
Battery (LiPo 3.7 V)
Power consumption 50 mA
50 mA
Storage Conditions
from +5°C to +45°C
Device operating conditions
from +15°C to +40°C
Dimensions
118x38x48 mm
Weight:
0.3 kg

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2.1.3 Schematic structure of AioCare
2.1.4 AioCare assemblies
The parameters of all parts are exactly reproducible. A flow tube is connected to the measurement module
through the tube grip. The air flows through two air channels and one bypass fluid channel. Prior to testing
a new patient, the bacterial filter found in the package should be connected to the tube. The measurement
tube maintains its parameters until mechanical destruction.
3. Testing
3.1 Calibration of the spirometry system
The device is calibrated by the manufacturer. The sensor and flow tube are calibrated in the full range of
flow rates measured using a precise flow generator and don’t require the user to conduct any calibration
prior to first use.
All spirometry standards (including ATS/ERS) recommend that the reliability of pulmonary measurement
devices should be checked at least once daily with a 3L calibration syringe when AioCare is used in clinical
and hospital environment.
With normal use, calibration or calibration check is recommended as part of the annual routine maintenance
service. This service is available at health care facilities or at the headquarters of AioCare manufacturer.
3.2. Flow-volume loop
Figure 1 Structure of AioCare.

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The patient is breathing through the bacterial filter and flow tube. After several quiet breathing cycles, s(he)
exhales as deep as possible and takes as quick and deep breath as possible and then exhales as quick
and deep as possible. This manoeuvre is repeated several times.
3.3. Spirometry
Prior to the test, rest for at least 15 minutes. For safety reasons (possible fainting), a spirometry test is
conducted usually in a sitting position. Prior to measurement, attach the bacterial filter (IMPORTANT: in the
case of infection accompanied by coughing when the device is used individually, and always when AioCare
is used in clinical or hospital environment) and the nose clip to the flow tube, make several quiet breathing
cycles, and make a slow, deepest possible exhalation, followed by quickest and deepest possible inhalation.
After that, make deepest possible forced exhalation continued for as long as possible. The measurement
may be repeated after regular breathing is restored, but not earlier than after 30 seconds. At least 3 correct
measurements are required, and when there is no reproducibility –no more than 8 measurements. The
flow-volume loop should be measured correctly at least 3 times. The measurements are considered
reproducible if the two highest FVC values differ from each other by no more than 200 mL and also the two
highest FEV1 values differ from each other by no more than 200 mL. The result of measurement are
maximum FEV1 and FVC values which don’t need to be obtained in the same test.
3.4. Flow reset
To increase the accuracy of measurement. Place AioCare in a horizontal position away from sources
generating the air flow and trigger the flow resetting function in the mobile application. The resetting is 5
seconds long, and the user is informed on its progress by visual representation on the display of the mobile
device.
4. Conducting testing
4.1. Preparing AioCare for operation
To prepare the device to operation, first clean the AioCare and do the following:

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4.2 Communication between AioCare device and user
4.3 Hardware and software requirements for the mobile device
AioCare spirometer is operated through AioCare applications for iOS and Android. These applications are
available at Apple App Store and Google Play. The applications work on versions at least iOS 9.0+ and
Android API 21+ (5.0). The communication between AioCare and applications in via Bluetooth 4.0 (BT LE).
The mobile devices on which the applications are installed must be equipped with that version. iPhone
version must be at least iPhone 5S. We don't recommend operating the application on tablets or iPads.
4.4. First launch of application
Upon installing the AioCare application, to continue using it, you need to create a doctor’s or user’s account,
or log in if such account is already in the system.
CAUTION: You should contact the manufacturer if you need any advice on installing or using, or to
report unexpected operation or event.
Log in
If you already have an account, you can log in by using the “Zaloguj” [Log in] button, entering your
assigned ID and password received from your doctor.

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Main screen
On the main screen, you have access to the following functionalities:
Button opening the application main menu containing:
•Button to start a spirometry test
•Log
•Statistics
•My device
•My profile
•Help
•Shop
•Settings
•About us
1. User welcome screen
2. Icon of connection to device
3. Button to start a spirometry test
4. Result of the last spirometry measurement
5. Information on ambient condition: pressure, temperature and humidity.
6. Button opening the Log
7. Button opening the Statistics

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4.6. Conducting a test
A spirometry test begins by pressing “Start” on the main screen. It redirects to the test screen. Make sure
the device has been connected and paired with the application, then reset the flow.
The next step displays the measurement preparation screen. Prepare the spirometer, filter and nose clip.
When the patient is ready, press “Start”.

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Next displayed is the “live” measurement screen with visualisation and graph of the flow rate in real time.
Measurement is stopped by pressing the “Stop” button.
4.7 Measurement results
Spirometry
The first screen shows the interpretation of results, and all measured spirometry parameters are shown at
the bottom. Measurement results can be recorded or discarded by pressing the appropriate button on the
screen. If the measurement is carried out incorrectly, the application indicates an error in the left upper
corner of the screen and marks incorrect test.

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5. AioCare spirometer maintenance
5.1 Operation guidance
Tests and safety
AioCare has been tested by an independent laboratory which has certified the conformity of the device with
the European standard for electric safety and for home use (EN 60601-1 and EN 60601-11) and warrants
its conformance with electromagnetic compatibility requirements set out in the EN 60601-1-2 European
standard.
AioCare is constantly controlled in the manufacturing cycle, which ensures that the safety levels and quality
standards set out in Council Directive 93/42/EEC on medical devices are met.
CAUTION: Safety and correct operation of the device can be ensured only when the user complies
with all essential safety principles and regulations.
The manufacturer is not liable for any damage caused by failure to comply with the user manual.
This device may be used only as a spirometer, with the use of only original spare parts and
accessories.
Failure to comply with this caution may lead to device damage, incorrect measurement and the loss
of warranty.
Cleaning
The flow tube can be rinsed with water or washed with generally available washing agents. The tube must
be cleaned up before first use and each time after measurement. The flow tube must be clean, dry and free
from foreign bodies in the air flow channels. After each test, the tube should be thoroughly washed, and any
foreign bodies and visible dirt removed using a soft cloth.
Disposable MADA 29 mm filters are recommended.
CAUTION: Each time make sure that the flow tube contains no liquid left after washing. The tube’s
air channels used for testing must be thoroughly dried up. Failure to comply with this caution may
lead to device damage or incorrect measurement.
The flow tube can be washed with running water. Don't wash AioCare in a dishwasher.
Daily operation:
- check if there is no obstruction in the flow tube,
- check the mechanical condition of the flow tube and the measuring module.

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CAUTION: Bacterial filter must be used. Don’t use the same filter if you test different patients on
the same AioCare device. Failure to comply with this caution may lead to cross- or secondary
contamination.
PRECAUTIONS:
1. Don’t use this device while charging!
2. Disposable filter must be used if you test different patients on the same AioCare device. Failure
to comply with this caution may lead to cross- or secondary contamination.
3. While charging, the battery should be at a place with room temperature. Never expose to
temperatures less than -10°C or more than 45°C!
4. Use the USB cable bundled with the product.
5. The battery may be charged even if it is not completely discharged. Battery performance
deteriorates with time, so the device can work for a shorter time, and may need to be charged
more frequently and longer!
6. Protect against moisture and don’t immerse in water. A dry anti-static cloth may be used for
cleaning the spirometer proper (measurement module)!
7. Don’t dismantle the battery. Avoid dropping the device, especially on hard surfaces. Don’t
attempt to dry up the device using other equipment or source of heat, such as a hair drier or
microwave oven.
8. If the device is damaged, it should be switched off and secured against unintended operation.
This device cannot be used safely when it: - has evident signs of mechanical damage! - doesn’t
work correctly (LED not glowing)! - has been stored in adverse conditions (-10°C or above 45°C,
high air humidity –more than 70%)! - has been damaged in transport!
9. The device must not be used in the following adverse ambient conditions: –Moisture or high air
humidity –Dust and flammable gases, vapours or solvents –Storms and stormy conditions,
such as strong electrostatic fields, etc.
10. The device must not be modified or tampered with.
11. Any mechanical damage to the device may cause its malfunction.
12. Any use, operation or maintenance of this product inconsistently with the user manual is not
allowed, and may lead to user-caused damage for which the manufacturer is not liable.
CAUTION: AioCare may give unreliable measurements if it’s used in the presence of strong
electromagnetic fields.
CAUTION: In the event of any incident or accident related to the use of this device, the user is
required to immediately notify the manufacturer of this fact.
Failure to comply with above caution may lead to device damage and/or incorrect measurement.
6. Meaning of symbols used by the manufacturer

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Plate on AioCare device
example: MS-
16110001 (where
16 is the year of
manufacture/11 –
month of
manufacture/
0001-consecutive
number of the
piece)
CE - this symbol
means that the product
has the certificate of
compliance with Class
IIa according to
Directive 93/42/EEC
on medical devices.
WEEE warning
symbol; waste –
electric
component;
disposal in
compliance with
national
regulations
USB symbol –use
only the USB cable
provided by
manufacturer and
comply with safety
regulations defined by
standard IEC 60601-1-
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Electric safety
symbol –BF
applicator
conforming to
standard IEC
60601-1
Symbol –always
consult the user
manual
FCC ID:
Device complies
with Part 15 of
FCC (Federal
Communications
Commission) rules
and regulations
Symbol - “This device
contains a radio
frequency (RF)
transmitter”; conforms
to electromagnetic
compatibility

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Symbol -
Manufacturer
(Address and
contact details)
IP22- protection level
provided by the
enclosure of electrical
device against the
ingress of foreign
bodies and harmful
effects of moisture
ingress
7. Maintenance
Wipe the case of the measurement module with a soft cloth. Never wash under running water!
CAUTION: Don’t let the device be poured over with a liquid. Failure to comply with this caution
may lead to device damage or loss of warranty.
7.1. Operation of AioCare power supply
AioCare is powered by a300mAh 3.7V LiPo battery installed inside the measurement module. Fullycharged
battery is capable of working continuously for 5.5-6 hours. The user is notified on the battery status in the
mobile application or through LED signals on the device casing. 4 out of 8 LEDs glowing means that the
battery is low on power. In such event, stop the testing within several minutes and charge the device using
the bundled USB cable attached to any PC/Mac device.
7.2. Battery charger
The measurement module has 2 charging functions:
1. Wired, through the USB cable
The battery should be charged based on the in-built charging system which protects it against damage
during the charging and ensures its long life. To start charging, connect one side of the USB power cable
to the charging socket in the casing of the measurement module, and the other side to any PC/Mac power
source connected to the 230 V mains. This will make the LEDs on the device casing glow, which signals
that the charging process is correct. During the charging of the measurement module, the functions of the
spirometer are switched off, and you cannot do any testing at that time (the device cannot be turned on with
the “ON/OFF” button). The charging process should last 3.5 hours for the battery to be fully charged. Full
charge is signalled with another lighting up of all 8 LEDs.
2. Wireless, using NFC technology (any NFC charger with certificate of marketing in the EU market)
The battery should be charged based on the in-built charging system which protects it against damage
during the charging and ensures its long life. To start charging with NFC technology, disconnect the
measurement tube from the measurement module. Then place the measurement module on the NFC
charger with its no-buttons side. This will make the LEDs on the device casing glow, which signals that
the charging process is correct. During the charging of the measurement module, the functions of the
spirometer are switched off, and no testing can be conducted at that time (the device cannot be turned

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on with the “ON/OFF” button). The charging process should last 3.5 hours for the battery to be fully
charged. Charging time may depend on the power rating of the charger used. Full charge is signalled
with another lighting up of all 8 LEDs.
CAUTION: To avoid device damage, only the above-mentioned devices identified by the
manufacturer should be used.
7.2.1. Battery replacement
The battery is not replaceable.
CAUTION: Replacing the battery on your own may result in:
- damage to the measurement module
- battery explosion or ignition
- damage to the battery
- electric shock
- burns
- loss of warranty for the entire AioCare spirometry system
The battery life is designed for 500 full charging cycles or 1 year of intensive use 6 hours a day. After that
number is reached, the actual battery performance may fall to 60% of its nominal performance. This will
result in quicker discharging of the battery.
Battery life is estimated by the manufacturer at 2 years and is a precondition for the device to be
used. After 2 years of starting using the device, AioCare is used by the user only on their own
responsibility.
8. Disposal
A device that is no longer needed or cannot be repaired should be disposed of in accordance with local
regulations. Don’t discard spent devices or batteries into ordinary garbage bins. Contact a recycling
company to do that. The device may be returned to the manufacturer, distributor or a recycling company. If
the battery inside the device is damaged, send the product back to the manufacturer.
9. Warranty
This device is covered by 2 years’ warranty.
The warranty does not cover any damage caused by using the device inconsistently with the user manual,
using the device inconsistently with its intended purpose, or failure to comply with safety requirements and
cautions in Section 5.1 of this manual.
10. Defects and malfunction
If you notice any malfunction, defect, deterioration of features or performance of the product, or
inappropriate marking or instructions for use that could have or can lead to death or significant health loss
of the patient or product user, immediately stop using the product and contact the manufacturer by e-mail
or telephone to describe the defect and receive the required instructions for how to further handle the
product.

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