SpiroLite User Manual
WHAT’S IN THE BOX Aerobit SpiroLite Device 2x AAA Batteries Reusable Turbine with Mouthpiece
SETTING UP YOUR DEVICE 1) Download the Aerobit App from Google Play store or Apple App Store 2) Login or Register on the App using Email, Facebook or Google Account 3) Enter information such Age, Gender, Ethnicity, Avatar etc when prompted
SETTING UP YOUR DEVICE 4) Enable Bluetooth and GPS from your phone settings. 5) Open the battery latch from behind by gently pushing on the grips and pulling it downwards 6) Insert the two AAA batteries into the battery cabinet.
PERFORMING A LUNG FUNCTION TEST 4) Insert the turbine in the device, gently push inside to make sure it has reached the end 5) Rotate the turbine clockwise to lock it in place.
PERFORMING A LUNG FUNCTION TEST 7) Inhale deeply. 8) Seal your lips onto the mouthpiece. 9) Exhale as fast as possible into the turbine.
PERFORMING A LUNG FUNCTION TEST 10) The App will display the PEF, FEV1 values along with the graph. Tap Next Test for conducting next test (repeat steps 7 to 9). Take at least 10 seconds rest between each test. 11) After completing four tests, the device will go to Standby mode and the App will display the best of the four tests.
INDICATIONS FOR USE SpiroLite is intended for monitoring PEF (Peak Expiratory Flow Rate), FEV1 (Forced Expiratory Volume in one second), FVC(Forced Vital Capacity) and FEV1/FVC Ratio for patient home use. The device is designed for paediatric to adult patients. GENERAL INFORMATION SpiroLite is used to measure a person’s PEF (Peak Expiratory Flow) and FEV1(Forced Expiratory Volume). PEF is the fastest speed a person can blow air out of the lungs after taking in as big a breath as possible.
into the turbine. The airflow generated sets a rotor in motion. SpiroLite registers the speed of the spinning rotor, converts it and transfers the data via Bluetooth to the smartphone app. CAUTION When a peak flow meter is used to watch lung conditions such as asthma, the user should be under the care of a physician (or other licensed health care professional).
unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax, thoracic, abdominal or cerebral aneurysms, recent thoracic, abdominal or eye surgery, acute disorders such as nausea or vomiting, severe respiratory distress, physical limitations, cognitive impairment, dementia. IMPORTANT SAFETY WARNINGS do not use it and contact us immediately. • Use only in environments specified in this user manual. • Do not expose to liquids.
CE mark: indicates that the device is certified that it conforms to the requirements of the 93/42/EEC medical device directive. Waste electrical and electronic equipment: Dispose accordingly. Do not dispose as unsorted municipal waste. The symbol is used in accordance with IEC 60601-1-2:2014 (ED. 4) for products including radio transmitters and in accordance with EN 300 328. Manufacturer’s Serial Number. IP classification indicates that the device is protected against solid objects over 2.
nitrogen). The device is not designed to 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. The integrity and functionality are guaranteed by: • Never holding the turbine under a jet of water or air and never let it come into contact with high Follow operating instructions: temperature fluids.
It is highly recommended to use Aerobit Reusable Turbine and Mouthpieces only, usage of thirdparty turbines or mouthpieces could seriously impact the accuracy of the readings and safety of the patient. Cleaning the Aerobit Reusable Turbine To clean the reusable turbine, please refer to the following procedure: 1) Remove the Turbine from its compartment on the SpiroLite by turning it anti-clockwise and pressing lightly. It can be helpful to push it gently from underneath with one finger.
To avoid cross contamination, Aerobit Turbines are marked as single Patient Use accessories. However, to avoid selfcontamination, Aerobit Turbines should be properly cleaned before every use. movement. The cleaning of the turbine should be performed according to the instructions contained in the User’s Manual. SpiroLite Tests Parameters FEV1(Forced Expiratory Volume in 1 second) The volume of air (l) A forced maximal expiratory effort after a full inspiration.
STORAGE AND MAINTENANCE Handle SpiroLite device carefully. Store it in clean and moisture free conditions. Before use, always check that the device is free from dust, contamination or any particles. SpiroLite does not require professional maintenance. If, however, the outside of the device needs to be cleaned make sure to only use a damp cloth without any detergents. The batteries of SpiroLite are replaceable. If the storage temperature is below 20C, allow the device to warm up before use.
no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ·Reorient or relocate the receiving antenna. · Increase the separation between the equipment and receiver.
that may cause undesired operation -Make sure the turbine is not of the device. spinning before starting the test. -Make sure there is enough battery The products are compliant with SAR for general population/uncontrolled before you do a test. exposure limits in IC RSS-102 and -Make sure the environment is not has been tested in accordance with too windy or bright. the measurement methods and procedures specified in IEEE 1528.
TECHNICAL FEATURES Environment of use Home, Clinic or hospital setting Measurement method Infrared Interrupt Power Supply 2 x 1.
Atmospheric Pressure 1000 hPa – 750 hPa Communication Bluetooth Expected service life of SpiroLite and Aerobit Turbine Regulations applicable 2 Years ISO 23747 ISO 26782 IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 In case of questions, feedbacks or concerns, please contact us at: customerservice@aerobithealth.
Fairfax, VA, 22030 USA Aerobit Labs Pvt ltd 303, Nyati Emporius, Mahalunge Baner, Pune 411045 India Version USM_1.
