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Smart One

Page 2 of 33

User Manual

Rev.2.9

Date

Measurements

Recommendation

Physician

PEF

FEV1

Reserved for the physician or other licensed health care professional to write your good

flow rates and to provide specific interventions he/she recommends for ranges of

decreased flow rates.

Содержание SMARTONE

Страница 1: ...FORE 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 User Manual Rev 2 9 Issue Date October 03 2017 0476 is registered trademark of MIR S r l MEDICAL INTERNATIONAL RESEARCH ...

Страница 2: ... Date Measurements Recommendation Physician PEF FEV1 Reserved for the physician or other licensed health care professional to write your good flow rates and to provide specific interventions he she recommends for ranges of decreased flow rates ...

Страница 3: ...se in electromagnetic environments 18 6 3 Notes on fcc certification 19 7 CARE AND CLEANING 19 7 1 Cleaning and disinfection of the turbine 20 7 2 Cleaning and disinfection of the mouthpiece 21 7 3 Cleaning of the device 21 7 4 Replacing batteries 21 8 ERROR MESSAGES 22 9 TROUBLESHOOTING 23 10 Accuracy and Reliability 24 11 LABELS SYMBOLS 24 12 TECHNICAL SPECIFICATIONS 26 13 Bluetooth Wireless Tec...

Страница 4: ...m 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 Keep the original packaging If your product has a problem use the original packaging to ship it back to your local distributor The manufacturer cannot be held responsible for any damage caused by users failing to...

Страница 5: ...ive pulmonary disease and other lung disease to better manage their conditions It is important to watch for changes in your PEF or FEV1 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...

Страница 6: ...n the healthiest physical condition The MIR SMART ONE app can calculate the PEF or FEV1 predicted value i e the expected value for healthy people depending on age height sex and origin MIR SMART ONE app calculate the PEF or FEV1 predicted value that has been endorsed by ATS American Thoracic Society for PEF the predicted values are calculated according to Knudson R J Slatin R C Lebowitz M D Burrow...

Страница 7: ... 611 80 149 206 262 318 375 431 488 544 600 85 139 195 252 308 364 421 477 534 590 90 128 185 241 297 354 410 467 523 579 PEF table female L m Height cm 120 130 140 150 160 170 180 190 200 AGE 5 165 194 224 253 283 312 341 371 400 10 212 241 271 300 330 359 388 418 447 15 259 289 318 347 377 406 436 465 494 20 279 308 338 367 396 426 455 485 514 25 271 301 330 359 389 418 448 477 506 30 264 293 32...

Страница 8: ...NDER 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 INCLUDING WHICH PARAMETER TO USE PEF OR FEV1 DIAGNOSIS AND APPROPRIATE TREATMENTS ARE TO BE GIVEN ONLY BY A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFE...

Страница 9: ... 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 BASELINE VALUE FOR PEF OR FEV1 MUST BE D...

Страница 10: ...here is a connection read the messages from the app 5 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 i...

Страница 11: ...rogression 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 PEF or FEV1 Written asthma action plan Regular medical review The above indicates that when engaged in self management of asthma your lung conditions can b...

Страница 12: ... treatment is working Discuss with your physician or other licensed healthcare professional when and how often to use your SMART ONE meter 5 1 Diary record The MIR SMART ONE APP keeps a record of your highest reading of PEF or 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...

Страница 13: ...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 b...

Страница 14: ...he 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 ...

Страница 15: ...It is best to do the test standing or sitting upright makes no difference to test results 7 Take a slow deep breath as deep as you can Blow out as hard and fast as you can until you can read the result on the screen of your smartphone This is your PEF or FEV1 measure NOTE Avoid long slow exhalation Since each test session should consist of three trials repeat steps 4 7 twice more SMART ONE will sa...

Страница 16: ...e 80 of the baseline OK Your breathing condition appears under control Your medication is working Go ahead with your normal activities Yellow Above 50 and below or equal to 80 of the baseline Warning Use caution in your activity Refer to your action plan made by your physician or other licensed healthcare professional for action to be taken Red Below or equal to 50 of the baseline Danger Medical a...

Страница 17: ...lly 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 h...

Страница 18: ...h 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 6 2 Warnings for use in electromagnetic environments Due to the in...

Страница 19: ... to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee th...

Страница 20: ...e 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 pull it out of the SMART ONE socket by turning it counterclockwise and simply pulling it out To make it easier to pull out push the base of the turbine gently ...

Страница 21: ...air dry on a towel Store in a clean dry place in your home After cleaning insert the mouthpiece in the turbine by pressing lightly 7 3 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 7 4 Replacing batteri...

Страница 22: ...emove 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 8 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 ...

Страница 23: ... share the results of the tests but has not configured an Email account on the smartphone Set up an Email account from the smartphone settings menu 9 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 d...

Страница 24: ...facturer The test was performed wrongly Repeat the test following the directions on the smartphone screen Avoid sudden movements when you finish exhaling Discuss the value with your physician The turbine has not been inserted properly Insert the turbine from the front of the device by pushing it all the way down and turning it clockwise 10 ACCURACY AND RELIABILITY This device meets the requirement...

Страница 25: ... 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 protec...

Страница 26: ...tion interface Bluetooth SMART 4 0 or higher Power supply 2 x 1 5V AAA alkaline batteries Size Main body 109x49x21 mm Weight 60 7 g including batteries Type of electrical protection Class II Electrical protection level BF IP protection level IP22 Regulations applicable Electrical Safety IEC 60601 1 Electromagnetic Compatibility IEC 60601 1 2 ATS Standardization of spirometry 1994 Update Conditions...

Страница 27: ... once per 60 ms Includes 3 control bytes that allows the host to detect if packets are missing and the device to retransmit Quality of Service This device uses Bluetooth Smart technology for wireless communications which allows for reliable communications in electrically noisy environments and transmits packets once per 60 ms It includes 3 control bytes that allows the host to detect if packets ar...

Страница 28: ...vent undesirable operation of the device from unwanted electromagnetic interference 13 2 Radio frequency rf interference from other wireless devices Common consumer electronic devices that transmit in the same frequency bands used by the Smartone may prevent the uploader or mobile device from receiving data This equipment has been tested and found to comply with the limits for a Class B digital de...

Страница 29: ...ctly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The Smart One is intended for use in the electromagnetic environment specified below The customer or the u...

Страница 30: ...agnetic field IEC 61000 4 8 3 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity The Smart One is intended for use in the electromagnetic environment specified below ...

Страница 31: ...NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV bro...

Страница 32: ...ed separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic p...

Страница 33: ...eleted removed or rendered illegible The repair or replacement described in this warranty is provided for goods returned at the customers expense to certified service centres authorized by manufacturer For details of these centres please contact either your local supplier or the manufacturer Any unautorized opening of the device invalidates all guarantee claims Customer shall be responsible for al...

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