Healthup Sp z o o AIOCARE User Manual

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: (+48) 799 964 593, e-mail: info@AioCare.com

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

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:

o bronchodilators, o corticosteroids (asthma, COPD, interstitial lung diseases), o other medicines (e.g. antibiotic therapy in cystic fibrosis), o diuretics 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

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.

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

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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