MIR Smart One Manual

Before use

Before connecting SMART ONE to a smartphone, install the MIR SMART ONE free app, which you can download from the App Store (for iPhone and iPad) or Play Store (for Android devices).

After removing the device from its packaging, check that there is no visible damage. If there is, do not use the device and send it straight back for replacement.
Check if the packaging contains all the items shown below.

INTENDED USE

Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1^st second, VEMS). The device is intended for adult patients, adolescents and children over five years of age.

PEF is the maximum speed a person can blow air out of the lungs after taking as big a breath as possible.
FEV1 is the maximum volume of air a person can exhale from the lungs in one second after taking as big a breath as possible.

WHEN SMART ONE IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
Medical studies have shown that regularly reviewing accurate measurements of PEF and FEV1 with a physician or other licensed healthcare professional may allow individuals with lung disease to better manage their conditions.
It is important to watch for changes from one measuring to the next, and to follow the actions you have to take according to the action plan provided to you by your physician or other licensed healthcare professional.
If you have breathing conditions such as asthma your physician or licensed healthcare professional may recommend that you measure PEF/FEV1 to watch your disease and discover if there are changes in your airflow. When you blow into the mouthpiece of the flow meter, the device will display a number. The faster you blow, the higher the reading.
This number tells you how well air is moving through the airways in your lungs. When you use SMART ONE regularly, you will be able to detect changes in your measurements, which will tell you and your physician or other licensed healthcare professional what is happening with your lungs.
These changes may require special treatment of your condition according to the action plan given to you by your physician or licensed healthcare professional which will tell you when and how often to use your SMART ONE meter. They also will explain how your PEF and FEV1 measurements help them monitor your lung function and how well treatments are working.

DETERMINING YOUR PEF BASELINE VALUE

A PEF measure with a high value usually means that your airflow is good.
The best way to determine what is a healthy PEF for you is to discuss this with your physician or other licensed healthcare professional. In fact the importance of any changes in airflow from one measuring to the next depends upon how much they are different from your baseline value you should reach when you are in healthy physical condition.
Your physician or other licensed healthcare professional will use one of two possible ways to identify your baseline value. The first method adopts the predicted value calculated according to the results of epidemiological studies of large groups of healthy subjects of your same age, height, sex, and origin. The second method adopts the personal best value you can reach when you are in the healthiest physical condition.
The MIR SMART ONE app can calculate the PEF predicted value, i.e. the expected value for healthy people, depending on age, height, sex, and origin. MIR SMART ONE app calculate the PEF predicted value that has been endorsed by ATS (American Thoracic Society): PEF predicted values are calculated according to Knudson, R. J., Slatin R. C., Lebowitz, M. D., Burrows, B., The Maximal Expiratory Flow-Volume Curve – Normal Standards, Variability, and Effects of Age, AM REV RESPIR DIS, 1976 113;587-600.
In this case, the predicted value becomes the baseline value for your treatment plan. If your physician or other licensed healthcare professional prefers this method, MIR SMART ONE app provides the calculation of the predicted PEF value.
It is important to know that these predicted values are average numbers for large groups of people. You may have a higher PEF measure than the predicted value and you may not be healthy. Or you may have a lower PEF than the average and be healthy.

NO MATTER WHICH METHOD YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL PREFERS TO USE, IT IS IMPORTANT THAT YOU CLEARLY UNDERSTAND THE MEANING OF YOUR BASELINE VALUE AND HOW IT RELATES TO YOUR TREATMENT PLAN. IF YOU HAVE TROUBLE DETERMINING YOUR BASELINE VALUE, ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL FOR ASSISTANCE.

CONTRAINDICATIONS

The ATS/ERS guideline updated 2019 sets out the relative contraindications of spirometry as follows: Acute myocardial infarction within 1 week; Systemic hypotension or severe hypertension; Significant atrial/ventricular arrhythmia; Uncompensated heart failure; Uncontrolled pulmonary hypertension; Acute pulmonary heart; Clinically unstable pulmonary embolism; History of syncope related to forced exhalation/cough. Cerebral aneurysm; Brain surgery within 4 weeks; Recent concussion with persistent symptoms; Eye surgery within 1 week.
Due to increased sinus and middle ear pressure: Sinus or middle ear surgery or infection within 1 week. Presence of pneumothorax; Thoracic surgery within 4 weeks; Abdominal surgery within 4 weeks; Pregnancy beyond term. Active or suspected transmissible respiratory or systemic infection, including tuberculosis; Physical conditions predisposing to transmission of infection, such as haemoptysis, significant discharge or oral lesions or oral bleeding.
If at least one of these conditions affects you, consult your doctor or a health care professional before using the device.

HOW TO START USING THE MIR SMART ONE APP

Follow the instructions in the Maintenance section for correct battery insertion.
Before connecting SMART ONE to a smartphone, install the MIR SMART ONE free app, which you can download from Apple Store (for iPhone and iPad) or from Play Store (for Android devices).

Launch the MIR SMART ONE APP and carry out the following steps.

These are one–off operations that do not need to be repeated next time you enter the app.

1. Authorize data exchange with the Health app, which is already installed on your smartphone. The user can decide whether or not to allow
   • the following data to be written to the Health app: height, weight, PEF and FEV1
   • the following data to be read from the Health app: height, weight, date of birth, gender.

You can allow or deny authorization for each parameter.

2. Enter your personal details: date of birth, origin, weight, height, sex.

The MIR SMART ONE APP will use these data to calculate PEF baseline value, and will use it to assign a colored marker to your test (green, yellow, red). Please refer to the section DETERMINING YOUR PEF BASELINE VALUE for a clear understanding of the baseline value. If you don't enter your data, a warning message will be issued.
Connection between SMART ONE and your smartphone is automatic. To check whether there is a connection, read the messages from the app.

HOW SMART ONE WORKS

SMART ONE is an electronic device for home use that accurately measures your PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec).
PEF is the maximum speed a person can blow air out of the lungs after taking as big a breath as possible while FEV1 is the maximum volume of air a person can exhale from the lungs in one second after taking as big a breath as possible.

WHAT IS THE SCIENTIFIC BASIS FOR PEF AND FEV1 HOME MEASUREMENT?
The first portable mechanical meter to measure PEF was introduced in 1959 by B. Wright. The widespread use of this device to monitor children greater than five years of age and adults has made it a popular means of tracking the degree of respiratory conditions in patients with asthma and other pulmonary conditions.
Inexpensive, small, portable, and easy to use electronic meters for evaluating respiratory conditions are now widely available. They offer several advantages including the ability to record PEF and FEV1, and to store and transfer data to a physician or other licensed healthcare professional.
SMART ONE provides a warning message if a test is not correctly performed, for example if instead of blowing out as hard and fast as you can, you exhale too slowly. This is another clear advantage compared to a mechanical peak flow meter that does not provide any message.
PEF and FEV1 are measured during the same exhalation. When the test is correctly performed, PEF is measured 0.10–0.15 seconds after the blow start, while FEV1 is measured exactly 1.0 second after the blow start.
According to best current evidence from several scientific studies, research paper topics and clinical expertise, both PEF and FEV1 have proven to be good indicators of airflow function in health and illness that can indicate how well you are breathing, and can help you determine if there are changes in your airflow. Regular measurements of PEF and FEV1 provide evidence of disease progression.
The GUIDE FOR ASTHMA MANAGEMENT AND PREVENTION published in 2016 by GINA (Global Strategy for Asthma Management and Prevention) states:

Effective asthma self–management education requires:

• Self–monitoring of symptoms and/or lung function
• Written asthma action plan
• Regular medical review

The above indicates that when engaged in self–management of asthma, your lung conditions can be effectively monitored according with the written action plan prepared by a physician or a licensed healthcare professional.

A PHYSICIAN'S OR OTHER HEALTHCARE PROFESSIONAL'S ADVICE IS REQUIRED TO INTERPRET THE MEANING AND IMPORTANCE OF THE MEASUREMENTS REPORTED BY SMART ONE AND HOW TO DECIDE ON AN APPROPRIATE ACTION PLAN.
SMART ONE connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the MIR SMART ONE APP has been installed on your smartphone.
Each measure of PEF and FEV1 is transferred from the device to the smartphone to be displayed. Please use the PEF colored indicator (green, yellow or red) following your physician's or other licensed health care professional's advice. They will help you determine how to perform the test accurately and recommend actions when decreased values are measured.

WHEN SMART ONE IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
A higher value of PEF and FEV1 usually means air is moving easily through the lungs. When asthma attacks occur air cannot move easily through the lungs and lower values will be measured. It is generally recommended to take measurements as directed by the licensed healthcare professionals.
SMART ONE should also be used when you are feeling symptoms of breathing problems in order to help you and your physician or other licensed healthcare professional determine how serious the breathing problem is and how well your treatment is working. Discuss with your physician or other licensed healthcare professional when and how often to use your SMART ONE meter.

Diary record

The MIR SMART ONE APP keeps a record of your highest reading of PEF and FEV1 for both morning and evening session, complete with date and time. Dots between consecutively recorded readings are connected in order to form a trend graph. This on–going record is an important part of your asthma action plan.
The MIR SMART ONE APP can transfer the measured data to your physician or other licensed healthcare professional. When used properly, SMART ONE will help you and your physician or licensed healthcare professional monitor your asthma or other lung disease to provide the best treatment.
Reviewing the measured data can help you and your physician or other licensed healthcare professional check closely on your respiratory disease to provide the best treatment for you.
Because your smartphone has an automatic memory of hundreds of readings, you can take the device with you the next time you visit your physician or other licensed healthcare professional for a review of many readings.

Self–measuring of PEF and FEV1 value

PLEASE READ ALL THE INFORMATION IN THIS USER MANUAL BEFORE USING THIS DEVICE. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR PEAK FLOW AND FEV1 METER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
IF YOU DO NOT UNDERSTAND THE INSTRUCTIONS:
USA:
Call MIR USA 1-844-4MIRUSA (1-844-464-7872), Monday to Friday 8 AM to 5 PM (central time), OR CONTACT US AT mirusa@spirometry.com, OR WRITE US AT MIR USA, Inc. 5462 S. Westridge Drive New Berlin, WI 53151 – USA.
EUROPE and WORLDWIDE:Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), OR CONTACT US AT mir@spirometry.com, OR WRITE US AT MIR Via del Maggiolino 125, 00155 Roma, Italy.
ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL TO WATCH YOU USE THE PEAK FLOW METER. THIS WILL HELP ASSURE YOU ARE USING IT CORRECTLY.
NO MATTER WHAT YOUR PEAK FLOW MEASURES ARE, IF YOU HAVE SIGNS AND SYMPTOMS SUCH AS CHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD FOLLOW YOUR LICENSED HEALTH CARE PROFESSIONAL'S ADVICE FOR CONTACTING HIM OR HER.
IF YOU ARE UNABLE TO OBTAIN A READING YOU SHOULD CONTACT YOUR PHYSICIAN IMMEDIATELY.

SMART ONE must be cleaned as shown in CARE AND CEANING section before your initial trial and periodically thereafter.
To carry out a measurement:

• Run the MIR SMART ONE APP on your smartphone
• Press the START icon
• Wait for Bluetooth connection

1. Push the turbine into the slot until it stops
   
2. Turn the turbine clockwise until it stops
   
3. Insert mouthpiece at least 0.5 cm into the turbine socket.
   
4. Your SMART ONE is now ready.
   Hold SMART ONE with your hand as if it were a cell phone and make sure not to obstruct the turbine with your hand.
   
5. Insert the mouthpiece end into your mouth beyond your teeth, and close lips around the mouthpiece. Make sure your lips form a tight seal around the mouthpiece.
   
   To prevent turbulence that might otherwise affect the results do not put your tongue in the mouthpiece. Do not bend your neck.
6. It is best to do the test standing or sitting upright (makes no difference to test results).
   
   • Take a slow deep breath as deep as you can.
   • Blow out as hard and fast as you can until you can read the results on the screen of your smartphone.
   • This is your PEF and FEV1 measure.
7. NOTE: Avoid long slow exhalation
   Since each test session should consist of three trials, repeat steps 4–7 twice more.
   SMART ONE will save the highest value.

Supervision of an adult is required for testing elderly subjects, children and differently-able persons

Interpreting results

Three tests are performed per each session, after which the MIR SMART ONE APP automatically selects and save the highest PEF value and compares it with the baseline value. The app shows a graphic marker (green, yellow or red), which is then displayed as a colored circle around the PEF test result.

The meaning of the graphic marker is displayed in the following table.

ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USE YOUR SMART ONE BEFORE YOU RELY ON ANY MEASUREMENTS.

WHEN SMART ONE IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.

THE ACTION PLAN GIVEN TO YOU BY YOUR PHYSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL WILL TELL YOU WHAT ACTION TO TAKE WHEN THERE ARE CHANGES IN YOUR MEASURES.

NO MATTER WHAT YOUR MEASURES ARE, IF YOU HAVE SIGNS AND SYMPTOMS SUCH AS CHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD CONTACT YOUR PHYSICIAN OR LICENSED HEALTH CARE PROFESSIONAL.

CARE AND CLEANING

SMART ONE is a device that requires little maintenance. The following operations are to be performed regularly:

• Cleaning of the reusable turbine
• Cleaning of the mouthpiece
• Cleaning of the device
• Replacing batteries

Cleaning of the reusable turbine

To avoid irreparable damage to the turbine, do not use any alcoholic or oily cleaning solutions, and do not immerse in hot water or solutions. Do not try to sterilize the turbine in boiling water. Never try to clean the turbine under a direct jet of water or other liquids. If there are no liquid detergents, the turbine must at least be washed in clean water.

Correct operation of the turbine is guaranteed only if it is "clean" and free of foreign objects that affect its movement. The presence of dust or foreign bodies (such as hairs, sputum etc.) could slow or block the moving parts of the turbine and make the result less accurate, or damage the turbine itself. After each use, check the cleanliness of the turbine.
To clean the turbine, follow the steps below:

1. Remove the turbine from its housing by turning anti-clockwise and apply light pressure with your fingers from the bottom of the turbine to lift it out of its housing.
   
2. Mix ¾ cup of Clorox™ bleach (7.5%) in one quart of water. Place orange turbine in solution.
   
3. Shake the turbine to remove all impurities for at least 1 minute.
   
4. Let the turbine soak for 15 minutes.
   
5. Clean the turbine by immersing it in clean (not hot) water for at least 1 minute.
   
6. Remove excess water from the turbine by shaking it and let it dry by placing it vertically on a dry surface
   
7. Check that it is clean and free of any foreign bodies.
   
8. After cleaning, insert the turbine into the socket in the direction indicated by the closed padlock symbol screen-printed on the SMART ONE device. To insert the turbine correctly, push it down and turn it clockwise until it stops, to ensure that it is fully inserted into the plastic housing.
   

Cleaning of the mouthpiece

Be sure to clean the mouthpiece after each use, as outlined in the instructions below.

1. To clean the nozzle, simply remove it from the turbine.
   
2. Immerse the mouthpiece in warm water
   
3. Shake the mouthpiece for 2-3 minutes.
   
4. Rinse it in clean water.
   
5. Shake it gently to remove any excess water.
   
6. Let it dry on a cloth. Afterwards, insert the mouthpiece into the turbine with gentle pressure.
   

Cleaning of the device

Clean the device once a day. To clean, wipe the device's surfaces with a soft damp cloth. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry. Never put the device into water or other fluids.

Replacing batteries

The device continuously monitors the battery level. A message on the smartphone display alerts the user when the device battery is low. On fully charged batteries, the device is expected to work for 5 years or 1000 tests whichever comes first.
Used SMART ONE batteries should only be disposed of in special containers or preferably returned to the dealer of the device or to a special collection centre. In any case, all applicable local regulations must be complied with.

1. Remove the battery cover on the back of the SMART ONE
   
2. Remove the two batteries and replace them with two new ones, following the polarity as indicated by the symbols in the compartment
   
3. Reattach the battery cover
   

ERROR MESSAGES

If you encounter any problems when using the SMART ONE, a message will appear on the smartphone display to warn of the malfunction.

TROUBLESHOOTING

If you receive an unusually low reading, it could mean that your SMART ONE meter is broken, or it could mean that the reading is accurate and your asthma is getting worse. Check to make sure that the meter is not broken. You must follow directions exactly as instructed to obtain accurate results. If your meter is not broken, follow the instructions in your action plan for low readings and contact your physician or other licensed healthcare professional.
If you have any questions regarding the use of this device, please ask your physician or other licensed healthcare professional, or contact MIR USA, Inc.
Toll free number: 844–464–7872.
USA:
Call MIR USA 1-844-4MIRUSA (1-844-464-7872), Monday to Friday 8 AM to 5 PM (central time), OR CONTACT US AT mirusa@spirometry.com, OR WRITE US AT MIR USA, Inc. 5462 S. Westridge Drive New Berlin, WI 53151 – USA.
EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1), OR CONTACT US AT mir@spirometry.com, OR WRITE US AT MIR Via del Maggiolino 125, 00155 Roma, Italy.
If problems occur when using the device, the following points should be checked.

ACCURACY AND RELIABILITY

This device meets the requirements of the following standard:

• ATS Standardization of Spirometry 2005, 2019 update
• ISO 23747: 2015
• ISO 26782: 2009

LABELS & SYMBOLS

Symbols are described in the table below

SYMBOL			DESCRIPTION
Model:			Product Name
			Device serial number
			Manufacturer's name and address
			This product is a certified Class IIa medical device, and complies with the requirements of Regulation (EU) 2017/745 for medical devices.
			In accordance with IEC 60601–1 the product and its applied parts are type BF and thus protected against the risks of electrical leakage.
			This symbol is required by European directive 2012/19/EEC on waste electrical and electronic equipment (WEEE). At the end of its useful life this device must not be disposed of as normal domestic waste. Instead it must be delivered to a WEEE authorised collection centre. As an alternative, the device may be returned without charge to the dealer or distributor, when it is replaced by another equivalent device. Due to the construction materials used for the device, disposal as normal waste could cause harm to the environment and/or health. Failure to observe these regulations can lead to prosecution.
IP22			Indicates the degree of resistance to liquids. The device is protected against falling drops of water with a maximum inclination of 15° from vertical.
			The symbol is used for products including RF transmitters.
FCC ID			Identification showing traceability to FCC compliance
			Instruction for use symbol. Read this manual carefully before using the medical device
			Manufacturing date
			Temperature limits: indicates the temperature limits to which the medical device can be safely exposed
			Humidity limitation: indicates the range of humidity to which the medical device can be safely exposed
			The symbol indicates that the product is a medical device
			The symbol indicates the Unique Device Identification

SMART ONE complies with the Essential Requirements of Directive 93/42/EEC on Medical Devices. This statement is made on the basis of CE Certificate no. MED 9826 issued by Kiwa Cermet, Notified Body no. 0476.

TECHNICAL SPECIFICATIONS

SMART ONE complies with the Basic Requirements of Regulation (EU) 2017/745 for medical devices.

BLUETOOTH WIRELESS TECHNOLOGY INFORMATION

The Bluetooth^® word mark and logo are registered trademarks owned by Bluetooth SIG, Inc.

WARNINGS AND PRECAUTIONS

PLEASE READ ALL THE INFORMATION IN THIS USER MANUAL BEFORE USING THIS DEVICE. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR PEF AND FEV1 METER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
WHEN SMART ONE IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
A HEALTHCARE PROFESSIONAL'S ADVICE IS REQUIRED TO INTERPRET THE MEANING AND IMPORTANCE OF THE MEASUREMENTS REPORTED BY SMART ONE AND HOW TO DECIDE ON AN APPROPRIATE ACTION PLAN
DIAGNOSIS AND APPROPRIATE TREATMENTS ARE TO BE GIVEN ONLY BY A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THE ACTION PLAN WILL TELL YOU WHAT ACTION TO TAKE WHEN THERE ARE CHANGES IN YOUR MEASURES.
SELF–MEASUREMENT MEANS CONTROL, NOT DIAGNOSIS OR TREATMENT. IN ANY EVENT PLEASE BE SURE TO DISCUSS YOUR MEASURED VALUES WITH YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THEY WILL ALSO EXPLAIN WHICH VALUES ARE NORMAL FOR YOU.
NO MATTER WHAT YOUR MEASURES ARE, IF YOU HAVE SIGNS AND SYMPTOMS SUCH AS CHEST TIGHTNESS, SHORTNESS OF BREATH, COUGHING OR WHEEZING YOU SHOULD CONTACT YOUR PHYSICIAN OR LICENSED HEALTH CARE PROFESSIONAL.
FOLLOW INSTRUCTIONS CAREFULLY IN ORDER TO GET AN ACCURATE READING OF YOUR MEASURES. IF YOU ARE UNABLE TO OBTAIN A READING, CONTACT YOUR HEALTHCARE PROFESSIONAL.
ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTH CARE PROFESSIONAL TO WATCH YOU USE YOUR SMART ONE BEFORE YOU RELY ON ANY MEASUREMENTS.
MODIFYING YOUR ACTION PLAN OR MODIFYING YOUR BASELINE VALUE FOR YOUR PEF MEASUREMENT SHOULD ONLY BE DONE WITH DIRECTION FROM YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. DISCUSS WITH YOUR PHYSICIAN BEFORE PROCEEDING.
YOU SHOULD NEVER ALTER THE DOSAGE OF ANY MEDICATION WITHOUT TALKING TO YOUR PHYSICIAN.
THE DEVICE SHOULD NOT BE USED BY MORE THAN ONE PERSON. IF MORE THAN ONE PERSON WISHES TO USE THE DEVICE, ONE USER'S MEASUREMENTS MUST NOT BE ATTRIBUTED TO ANOTHER AND BOTH TURBINE AND MOUTHPIECE MUST BE CLEANED THROUGHLY AFTER EACH USE UNLESS MULTIPLE TURBINE AND MOUTHPIECE ARE AVAILABLE.
IF ANOTHER PERSON INTENDS TO USE THE DEVICE PERMANENTLY, THE PREVIOUS DATA STORED BY THE MIR SMART ONE APP MUST BE REMOVED AND THE NEW PEF BASELINE VALUE MUST BE DEFINED ACCORDING TO A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
ANY SERIOUS INCIDENTS OCCURRING WITH THE DEVICE MUST BE REPORTED TO THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE WHERE THE USER AND/OR PATIENT IS ESTABLISHED, IN ACCORDANCE WITH REGULATION (EU) 2017/745.

IMPORTANT SAFETY WARNINGS

Indicates a potentially hazardous situation, which, if not prevented, could result in minor or moderate injury to the user or patient or damage the device.
Supervision of an adult is required for testing elderly subjects, children and differently abled persons
The manufacturer cannot be held responsible for damage caused by the failure of the user to follow these instructions correctly.
Only original accessories as specified by the manufacturer must be used with the device.
Periodically check that no impurities or foreign bodies, such as skin, hairs have deposited inside the turbine. This may cause errors in measurement or compromise the correct functioning of the device.
Do not drop the device or treat it roughly in any way. Avoid strong vibration. Do not expose the device to extreme temperature, humidity, dust, sand, or chemical substances, or direct air currents (e.g. wind), sources of heat or cold, direct sunrays or other sources of light or energy.
Use and store the device in compliance with the environmental conditions specified in the Technical Specifications. If the device is subjected to environmental conditions other than those specified, it may malfunction and/or display incorrect results.
The maintenance operations set out in the User Manual must be carried out with the utmost care. Failure to follow the instructions may lead to measurement errors or misinterpretation of the measured values.
Do not modify the device without authorization from the manufacturer. All modifications, adjustments, repairs, reconfigurations must be performed by the manufacturer or by authorized personnel. In case of problems, do not try to repair the device yourself.

Data security warnings

Your smartphone stores your personal data. Potential threats such as the following:

• Malware installation
• Physical access to the smartphone
• Interception of communications
• Physical damage to the smartphone
• Theft of the smartphone could have an impact on the integrity or confidentiality of such data, such as:

• Accessing data in memory by unauthorized persons
• Loss of data in memory
• Inability to use smartphone for communications
• The integrity check of the data is made automatically and in case of transmission error it will create a corruption of the data and the file will be illegible

The following actions help reduce the risk of such events:

• Do not open or install files from suspicious sources
• Use antivirus software
• Back up your data periodically
• Do not leave your smartphone unattended
• Use a password to access the data
• Verify the correct Email address where to send the test results
• When data are transmitted call the physician to ask for confirmation of receipt

Warnings for use in electromagnetic environments

Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may be susceptible to electromagnetic interference from other equipment. Such electromagnetic interference could cause the medical device to malfunction, as well as a measurement accuracy lower than the one stated in paragraph 11, and create a potentially unsafe situation.
SMART ONE complies with EN 60601–1–2:2015 on electromagnetic compatibility (EMC for medical devices) for both immunity and emissions.
For the device to function properly, however, the following precautions must be taken:

• Make sure that the SMART ONE and the smartphone on which the MIR SMART ONE APP is installed are no more than 2 metres apart.
• Do not use SMART ONE near other devices (computers, cordless phones, cell phones, etc.) that generate strong electromagnetic fields. Keep such equipment at a minimum distance of 30 cm. If a use under lower distances is necessary, SMART ONE and the other devices should be kept under observation to verify their normal function.

Keep the original packaging! If your product has a problem, use the original packaging to ship it back to your local distributor:

MIR USA, Inc.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 – 6797; Fax + 1 (262) 364 – 2030
Website: www.spirometry.com; Email: mirusa@spirometry.com

EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, Monday to Friday 8 AM to 5 PM (GMT+1),
OR CONTACT US AT mir@spirometry.com
OR WRITE US AT MIR Via del Maggiolino 125, 00155 Roma, Italy.