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1 | User Manual II | Users Manual | 617.16 KiB | February 24 2022 |
Spirobank Oxi ENGLISH Oxi Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. User Manual Rev 1.5 Publication date 04.02.2022 WARNING: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR BY REQUEST OF A PHYSICIAN 0476 Ver. 1.5 User Manual Page 1 di 33 Spirobank Oxi ENGLISH CONTENTS 2. 1. 1.1 1.1.1 2.6.1 1.2 1.3 1.4 2.7 2.8 2.9 2.10 2.1 2.2 2.3 2.4 2.5 2.6 INTRODUCTION ....................................................................................................................... 4 Intended use ................................................................................................................. 4 Restrictions on Use ................................................................................................... 4 Description of product .................................................................................................. 5 Information on the parameters measured by Spirobank Oxi ........................................ 7 Determining your baseline values ................................................................................. 9 USE OF Spirobank Oxi .............................................................................................................. 9 Inserting the batteries .................................................................................................. 9 Installing the MIR SPIROBANK application .................................................................... 9 Connection between Spirobank Oxi and smartphone ................................................. 10 Performing the spirometry test .................................................................................. 10 Performing the oximetry test ..................................................................................... 13 Evaluating the test ...................................................................................................... 14 Results diary ........................................................................................................... 15 Important safety warnings .......................................................................................... 15 Data security warnings ............................................................................................... 16 Warnings for use in electromagnetic environments ................................................... 17 Notes on FCC certification .......................................................................................... 17 3. MAINTENANCE AND CLEANLINESS ........................................................................................ 18 Cleaning the reusable turbine ..................................................................................... 19 Cleaning of the mouthpiece ........................................................................................ 20 Replacing the FlowMir turbine ................................................................................. 20 Cleaning of the device ................................................................................................ 20 Replacing batteries ..................................................................................................... 21 ERROR MESSAGES & TROUBLESHOOTING ............................................................................. 23 Error messages ........................................................................................................... 23 Troubleshooting ......................................................................................................... 23 ACCURACY and reliability ...................................................................................................... 24 LABELS & SYMBOLS ............................................................................................................... 26 TECHNICAL SPECIFICATIONS .................................................................................................. 27 Bluetooth Wireless Technology Information ......................................................................... 30 Communication at radiofrequency (RF) ...................................................................... 31 Interference in radiofrequency (RF) caused by other wireless devices ....................... 31 9. WARRANTY TERMS ................................................................................................................ 33 3.1 3.2 3.3 3.4 3.5 5. 6. 7. 8. 8.1 8.2 4.1 4.2 4. Ver. 1.5 User Manual Page 2 di 33 Spirobank Oxi ENGLISH Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product. Before you use your Spirobank Oxi, please read this user manual, the labels and all the information provided with the product. Before connecting Spirobank Oxi to a smartphone, install the MIR SPIROBANK application, available by smartphone in both iOS and Android operating systems. The application enables display of the data measured by the device. The package includes:
The Spirobank Oxi device The turbine sensor (FlowMir) disposable or turbine reusable plastic mouthpiece 2 AAA batteries The User Manual After removing the device from its packaging, check that there is no visible damage. If it looks damaged, do not use the device and send it straight back to the manufacturer for replacement, where appropriate. Keep the original packaging!
If your product has a problem, use the original packaging to ship it back to your local distributor or to the manufacturer. The manufacturers address is as follows:
EUROPE and WORLDWIDE:
MIR SRL VIA DEL MAGGIOLINO, 125 - 00155 ROME (ITALY) Tel. +39 0622754777 - Fax +39 0622754785 Website: www.spirometry.com - Email: mir@spirometry.com United States of America MIR Medical International Research 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 Ver. 1.5 User Manual Page 3 di 33 MIR cannot be held responsible for any damage caused by users failing to follow these instructions and/or the warnings contained in this manual. Spirobank Oxi ENGLISH 1. INTRODUCTION Intended use 1.1 Spirobank Oxi, spirometer and pulse oximeter, is intended to be used by a physician or by a subject under the instruction of a physician or the patient to assess lung function. The device is designed for adult and pediatric patients, excluding infants and neonates, and can be used at home, in a factory, pharmacy, hospital or medical surgery. Restrictions on Use 1.1.1 Analysis of the test results alone will not be enough to diagnose your clinical condition; you will need a medical examination which will take your clinical history into account as well as any other tests recommended by the physician. Diagnosis and appropriate treatments are to be made and given only by a qualified physician. The device is intended for use by one patient only at a time. Take care not to attribute the measurements from one patient to another. Before using the device on a new patient, first erase the previous patients data from the memory and enter the new users details data (date of birth, origin, weight, height, gender). At each change of patient clean the device and check that a new FlowMir is being used or disinfect the re-usable turbine and the mouthpiece, as described in point 3. Ver. 1.5 User Manual Page 4 di 33 Spirobank Oxi ENGLISH Description of product 1.2 Spirobank Oxi is a pocket-sized system for measuring the following respiratory parameters:
PEF (Peak Expiratory Flow) FEV1 (Forced Expiratory Volume in 1 sec) FVC (Forced Vital Capacity) FEF2575 (Average flow between 25% and 75% of the FVC) FEV6 (Volume expired in the initial 6 seconds of the test) FEV1/FVC (Tiffeneau index) The device also measures the parameters related to the oximetry test in particular:
SpO2 (percentage of oxygen saturation in the blood) BPM (heart rate) The device connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the MIR SPIROBANK application has been installed on the smartphone. Measurement is performed by a turbine sensor, and is based on the infrared interruption principle. This principle ensures that the measurement is accurate and reproducible. The advantages of this type of sensor are:
Unaffected by the humidity and density of the gas Shockproof and unbreakable Spirobank Oxi can use either the FlowMir disposable turbine or the reusable turbine with plastic mouthpiece. Inexpensive to replace The F/V version calculates also the following parameters:
FIVC - Forced Inhalation Vital Capacity FIV1 - Forced Inspiratory Volume in the 1st second PIF - Peak Inspiratory Flow FEF25 - Forced Expiratory Flow at 25% of FVC FEF50 - Forced Expiratory Flow at 50% of FVC FEF75 - Forced Expiratory Flow at 75% of FVC EVol - Extrapolated Volume Ver. 1.5 User Manual Page 5 di 33 Spirobank Oxi ENGLISH FEV05 - Forced Expiratory Volume in the initial 0,5 seconds of the test FEV075 - Forced Expiratory Volume in the initial 0,75 seconds of the test FEV2 - Forced Expiratory Volume in the initial 2 seconds of the test FEV3 - Forced Expiratory Volume in the initial 3 seconds of the test FET - Forced Expiratory Time PEF Time - Time to achieve 90% of the PEF Also in the F/V version, the Flux / Volume curve (expiratory and inspiratory) is enabled in real time during the execution of the spirometry. The measurements are transferred in real time from the device to the smartphone. Ver. 1.5 User Manual Page 6 di 33 Spirobank Oxi ENGLISH Information on the parameters measured by Spirobank Oxi 1.3 Spirometry tests PEF is the maximum speed of the air when you exhale as hard as possible after filling your lungs completely. FEV1 is the volume of air expelled during the first second of the same exhalation. FVC is the volume of air expelled during the total exhalation. FEF2575 is the average flow between 25% and 75% of the total volume of air expelled during the total exhalation (FVC). FEV6 is the volume expired in the initial 6 seconds of the test. In addition to these parameters, the following parameters are also calculated in the F/V version:
PIF is the maximum speed of the air when you inspire as hard as possible after the exhalation. FIV1 is the volume of air inspired during the first second after the exhalation. FIVC is the volume of air inspired during the total inspiration. FEF25 is the Forced Expiratory Flow at 25% of FVC FEF50 is the Forced Expiratory Flow at 50% of FVC FEF75 is the Forced Expiratory Flow at 75% of FVC EVol is the back Extrapolated Volume FEV05 is the Forced Expiratory Volume expired in the initial 0,5 seconds of the test FEV075 is the Forced Expiratory Volume expired in the initial 0,75 seconds of the test FEV2 is the Forced Expiratory Volume expired in the initial 2 seconds of the test FEV3 is the Forced Expiratory Volume expired in the initial 3 seconds of the test FET is the Forced Expiratory Time and measures the length of the expiration in seconds PEF Time is the Time to achieve 90% of the PEF For each of these parameters, the result is a number shown on the smartphone screen. A high number (associated with a green light) usually means that the air is moving easily through your lungs. If you have asthma (or another respiratory disease) and have an obstructive episode, the air cannot generally be expelled as forcefully as possible, so your parameters will be lower. Ver. 1.5 User Manual Page 7 di 33 Spirobank Oxi ENGLISH Spirobank Oxi is a valid help in identifying whether there is an obstruction at a determined time and of what type of obstruction it is. Regular use of the device enables tracing the possible variations of the parameters. These variations might require suitable treatment, according to the prescription of the physician. As well as viewing the measurements of the respiratory parameters, the device also provides a normal baseline value. Oximetry tests During the oximetry test the device provides the instantaneous value of:
SpO2 (percentage of saturated oxygen in the blood) BPM (heart rate) Ver. 1.5 User Manual Page 8 di 33 Spirobank Oxi ENGLISH Determining your baseline values 1.4 The importance of any changes in airflow from one measurement to the next depends upon how much they are different from the baseline value you should reach when you are in healthy physical condition. The application can calculate the predicted value, i.e. the expected value for healthy people, depending on age, height, gender, and origin. The application calculates the predicted value that has been endorsed by ATS (American Thoracic Society): GLI-2012 All-Age Multi-Ethnic Reference Values by Philip H. Quanjer, Sanja Stanojevic, Janet Stocks, Tim J. Cole. For the PEF parameter, the 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. It is important to know that these predicted values are average numbers for large groups of people. The patient may have a higher measurements than the predicted value while not being healthy. Or the patient may have lower measurements than the average and still be healthy. 2. USE OF Spirobank Oxi 2.1 Follow the instructions in the Maintenance section for correct battery insertion. Inserting the batteries Installing the MIR SPIROBANK application 2.2 First you need to install application on your remote device (smartphone or tablet). The application is available for smartphone/tablet in both iOS and Android environments. Once the application is available, enter the patient's data; MIR SPIROBANK application will automatically calculate the baseline reference values. Ver. 1.5 User Manual Page 9 di 33 Spirobank Oxi ENGLISH 2.3 Connection between Spirobank Oxi and smartphone The connection between the Spirobank Oxi and the smartphone is automatic. To check whether there is a connection, read the messages from the application. 2.4 Performing the spirometry test To perform the test correctly, follow the instructions below. Push the FLowMir turbine into the slot until it stops Turn the turbine clockwise until it stops 1 2 Ver. 1.5 User Manual Page 10 di 33 Insert the mouthpiece at least 0.5 cm into the turbine socket Spirobank Oxi ENGLISH Pick up the Spirobank Oxi with your hands as if it were a mobile phone. Make sure not to obstruct the turbine with your hand. 3 5 4 6 in your mouth Insert the mouthpiece beyond your teeth, and close your lips tightly over it so that the air you breathe has to pass only through the mouthpiece. To prevent that might turbulence otherwise affect the results do not put your tongue in the mouthpiece. Do not bend your neck. the Start Test Tap SPIROMETRY on the app MIR SPIROBANK. icon under Ver. 1.5 User Manual Page 11 di 33 Spirobank Oxi ENGLISH Take a deep breath and blow out as hard as you can. It is best to do the test standing or sitting upright. (it makes no difference to test results) 7 After exhalation, slowly remove the device from the mouth and check the data on the smartphone. 8 After taking the mouthpiece out of your mouth, avoid sudden movements because this will push air into the turbine and a flow value will be measured that may affect the test results. Repeat the test three times. The MIR SPIROBANK will save the highest value. The device shows an error message if the exhalation start-up was not satisfactory and if the exhalation did not finish satisfactorily. Ver. 1.5 User Manual Page 12 di 33 2.5 Performing the oximetry test To perform the test correctly, follow the instructions below. Place the thumb of the hand holding the Spirobank Oxi on the sensor as in the image Tap the "Start Test" icon under OXIMETRY on the MIR SPIROBANK application. Spirobank Oxi ENGLISH 2 During the test the perfusion index is reported with a bar indicator. Minimum duration of a test is 30 seconds. 1 3 The device displays an error message if the sensor is not functioning and if the finger is not positioned on the sensor. If the signal detected is not of sufficient quality to estimate the oximetry parameters;
the parameters are not displayed. Ver. 1.5 User Manual Page 13 di 33 Spirobank Oxi ENGLISH 2.6 Evaluating the test For the spirometry measurements, three individual tests are made in each test, after which the MIR SPIROBANK application automatically selects the highest value and compares it with the baseline value
(personal best value) set during configuration. For the oximetry measurements, each test saved in the memory appears in the Results section, which contains the value of SpO2, the value of cardiac frequency, the date and time of the test and any notes. WARNING: ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USING THE Spirobank Oxi BEFORE RELYING ON ANY MEASUREMENT. WARNING: WHEN Spirobank Oxi IS USED TO MONITOR A LUNG CONDITION SUCH AS FOR EXAMPLE ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. WARNING: THE PLAN OF ACTION PROVIDED BY YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL WILL INDICATE WHICH ACTION TO TAKE IN A CASE IN WHICH THERE ARE RELEVANT VARIATIONS IN VALUES. WARNING: INDEPENDENTLY OF YOUR VALUES, AND EVEN WHERE THE DEVICE IS NOT INDICATING ALARMS, IF YOU ARE SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL. Ver. 1.5 User Manual Page 14 di 33 Results diary 2.6.1 The test results are automatically stored on the smartphone and can be displayed later. Spirobank Oxi ENGLISH 2.7 Important safety warnings Warning: 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. For monitoring elderly patients and children, and differently-able persons, the supervision of an adult is required. 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. Check that no impurities or foreign bodies, such as skin or hairs, have accumulated inside the turbine. Any modifications not expressly approved by this Company could compromise use of the device by the user. Check that there are no elements obstructing the oximetry sensor. Any modifications not expressly approved by this Company could compromise use of the device by the user. In the event of an accident of any kind arising from use of the device, you are strongly recommended to inform your physician so that he/she can notify the authorities as required by local legislation. 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 chemical substances. Use and store the device in compliance with the environmental conditions specified in the Technical Specifications. If the device is exposed to environmental conditions other than those specified, it might 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. Ver. 1.5 User Manual Page 15 di 33 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. If problems arise, do not try to repair the device yourself. Spirobank Oxi ENGLISH 2.8 Data security warnings The smartphone stores the users 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 of data in memory by unauthorized persons Loss of data in memory The integrity check of the data is made automatically and in case of transmission error it Inability to use smartphone for communications 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 Always check that the data used to send the results of the tests are correct Ver. 1.5 User Manual Page 16 di 33 Spirobank Oxi ENGLISH 2.9 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. This electromagnetic interference could cause the medical device to malfunction, such as an accuracy of measurement that is lower than the declared one, and create a potentially unsafe situation. Spirobank Oxi 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 Spirobank Oxi and the smartphone on which the MIR SPIROBANK application is installed are no more than 2 metres apart. Do not use Spirobank Oxi near other devices (computers, cordless phones, cell phones, etc.) that generate strong electromagnetic fields. Keep the above-described equipment at a distance of at least 30 centimetres. If a use under lower distances is necessary, Spirobank Oxi and the other devices should be kept under observation to verify that they are functioning normally. 2.10 Notes on FCC certification This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference 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 that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be Ver. 1.5 User Manual Page 17 di 33 Spirobank Oxi ENGLISH Reorient or relocate the receiving antenna. 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:
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Increase the separation between the equipment and receiver. Consult the dealer or an experienced radio/TV technician for help. 3. MAINTENANCE AND CLEANLINESS Spirobank Oxi is a device requiring little maintenance. The following operations must be carried out regularly:
Cleaning the reusable turbine Replacing the FlowMir turbine cleaning of the device replacing batteries The calibration of the device can be verified by carrying out a test for measuring FVC by using a calibration 3 litre syringe. Ver. 1.5 User Manual Page 18 di 33 Spirobank Oxi ENGLISH Cleaning of the reusable turbine 3.1 The following instruction should be applied in a case of reusable turbine. If the FlowMir is used, replace it after each session. To avoid irreparable damage to the turbine, do not use detergents including alcohol or oily substances and do not immerse the turbine in water or solutions at high temperatures. Never try to sterilise the turbine in boiling water. Never try to clean the turbine under a direct jet of water or other liquids. If you do not have liquid detergents available, the turbine must be washed at least with clean water. Correct functioning of the turbine is guaranteed only if it is clean and free of foreign bodies which interfere with 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, pull it out of the Spirobank Oxi socket by turning it counterclockwise and simply pulling it out. To make it easier to pull out, push the base of the turbine gently with a finger. Weekly cleaning is recommended. Immerse the turbine flowmeter in warm soapy water and shake the turbine for 2-3 minutes. Ver. 1.5 User Manual Page 19 di 33 Spirobank Oxi ENGLISH The hand dishwashing detergent that was tested includes the following ingredients:
Aqua, coco glucoside, myristyl glucoside, lauryl glucoside, sodium chloride, sodium gluconate, sodium citrate, allyl caproate, ethylene brassylate, methyldihydrojas-
monate). Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel. Store in a clean, dry place in your home. After cleaning, insert the turbine into the socket in the direction indicated by the screen-
printed closed padlock symbol on the Spirobank Oxi. To insert the turbine correctly, push it down and turn clockwise until it stops, to make sure it is fully inserted into the plastic container. Cleaning of the mouthpiece 3.2 Make sure to clean the mouthpiece after each use. To clean the mouthpiece, simply pull it apart from the turbine. Using the same method as for the turbine, immerse the mouthpiece in warm soapy water and shake the mouthpiece for 2-3 minutes. Rinse in clean water and shake gently to remove any excess water. Allow to 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. Replacing the FlowMir turbine 3.3 After each session, then every time you change patients, replace the FlowMir turbine with a new one. Then detach the one applied to Spirobank Oxi, operating in reverse order to the one described in point 2.4; then apply a new FlowMir before performing a new test session. The FLowMir used must be disposed of in accordance with the local laws in force. 3.4 Cleaning of the device Clean the device every time you change patients. Use only the substances and methods listed in this chapter to clean the device. Recommended cleaning agents are:
Mild soap (diluted) Ver. 1.5 User Manual Page 20 di 33 Spirobank Oxi ENGLISH Sodium hypochlorite bleach (10% diluted) Hydrogen peroxide (1.5%) Do not use alcoholic solutions. The use of such solutions can cause cloudiness on the surface. Moisten a soft cloth with a recommended solution, but not so much that the cloth drips, and lightly wipe the surface for 30 seconds. Let it air dry. Never immerse the device in water or other fluids. Replacing batteries 3.5 The device continuously monitors the battery level. A message on the smartphone display alerts the user when the device battery is low. When the batteries are completely charged the device has an operational span of five years or 1000 tests, whichever comes first. Remove the battery cover on the back of the Spirobank Oxi. Remove the two batteries and replace them with two new ones, following the polarity as indicated by the symbols in the battery compartment. 1 2 Ver. 1.5 User Manual Page 21 di 33 Reposition the battery cover. 3 Spirobank Oxi ENGLISH Used Spirobank Oxi batteries should only be disposed of in special containers or preferably returned to the dealer or to a special collection centre. In any case, all applicable regulations must be complied with. local Ver. 1.5 User Manual Page 22 di 33 Spirobank Oxi ENGLISH 4. ERROR MESSAGES & TROUBLESHOOTING Error messages 4.1 If you encounter any problems when using the Spirobank Oxi, a message will appear on the smartphone display to warn of the malfunction. MESSAGE Bluetooth POSSIBLE CAUSE Bluetooth is deactivated Battery low When the Spirobank Oxi batteries are below 15%
charge SOLUTION To perform measurements with the device, you must activate Bluetooth on the smartphone. Exit the application and activate Bluetooth from the smartphone settings menu. Replace the Spirobank Oxi batteries Troubleshooting 4.2 If you receive an unusually low reading, it could mean that your FlowMir meter is broken, or that the reading is accurate and your asthma is getting worse. Check that the FlowMir is not broken. Scrupulously follow the instructions to obtain accurate results. If problems occur when using the device, the following points should be checked. PROBLEM Spirobank Oxi cannot connect with the smartphone The test results are unreliable POSSIBLE CAUSE The Bluetooth connection is not working properly The turbine may be dirty SOLUTION Look for Spirobank Oxi on the list of recognized devices. For correct use, the smartphone needs Bluetooth version 4.0 or higher Clean the turbine as described in section 3.1. Replace the FlowMir with a new one, by contacting the manufacturer Ver. 1.5 User Manual Page 23 di 33 Spirobank Oxi ENGLISH PROBLEM POSSIBLE CAUSE The wrongly test was performed The turbine has not been inserted properly The oximetry test has not been stored The test lasted less than 30 seconds or the average value of the finger pressure was unsatisfactory SOLUTION Repeat the test, following the directions displayed on the screen. Avoid sudden movements when you finish exhaling Insert the turbine from the front of the device by pushing it all the way down and turning it clockwise. See the Performing the test section the test Repeat instructions given on the display and wait at least 30 seconds for the test to complete. following the 5. ACCURACY AND RELIABILITY This device meets the requirements of the following standard:
ATS/ERS TASK FORCE: Standardization of lung function testing (volume 26/numbers 1-5: 2005) Volume max Volume accuracy: the higher value between Max. peak flow Peak flow accuracy: higher value between 10 I 2.5% and 0.05 l (ATS 2019) 960 l/min (16 l/s) 10% and 20 l/min (0.33 l/s) Time zero At the point of peak expiratory flow (PEF), a tangent is drawn with a slope equal to PEF and its intersection on the abscissa defines TIME ZERO. The back extrapolated volume is the volume of gas that has already been exhaled at the point of TIME ZERO as defined by back extrapolation. The method to determine the time elapsed by TIME ZERO, t0, is given by the following equation:
Ver. 1.5 User Manual Page 24 di 33 Time zero = tPEF - (VPEF/PEF) Spirobank Oxi ENGLISH Where PEF is the peak expiratory flow;
tPEF is the elapsed time at PEF;
VPEF is the expired volume at PEF For the oximetry measurements, the device conforms to the requisites of the following standard:
ISO 80601-2-61:2017 Medical electrical equipment particular requirements for basic safety and essential performance of pulse oximeter equipment Range (SpO2) 70-100 %
70-80 %
80-90 %
90-100 %
Arms (%) 1.90 2.32 1.71 1.43 The Arms (Accuracy Root Mean Square), as mentioned in the above-cited standard, represents the accuracy of the device in terms of mean quadratic error of each SpO2 measurement, obtained by pulse oximetry, in relation to the respective reference value of SaO2, obtained by co-oximetry. The listed ranges show the different saturation intervals of oxygen for which the accuracy has been calculated. The accuracy of the device cannot be assessed with a tester. Ver. 1.5 User Manual Page 25 di 33 Spirobank Oxi ENGLISH 6. LABELS & SYMBOLS ID label The label shows:
Symbol Description Model: Product Name SN 0476 Series number of the device Manufacturers name and address: MIR s.r.l. Medical International Research, via del Maggiolino 125, 00155 Rome, Italy This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC 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/EU 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 for collection of waste from electrical and electronic equipment. 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. Indicates the degree of resistance to liquids. The device is protected against falling drops of water if it is arranged at up to 15 from the vertical. Ver. 1.5 User Manual Page 26 di 33 IP22 Spirobank Oxi ENGLISH Symbol Description The symbol is used to indicate that the product contains RF transmitters. FCC ID Identification showing traceability in compliance with FCC Standards Instructions for use symbol. Read this manual carefully before using the medical device Production date Rx ONLY Reference to US FDA regulations: use the device on prescription 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 Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed 7. TECHNICAL SPECIFICATIONS Measured spirometry parameters:
Peak Expiratory Flow Expiratory Volume in one second of testing Forced Vital Capacity Expiratory Volume in the initial 6 seconds of the test Average flow between 25% and 75% of the FVC Tiffeneau index PEF (L/min) FEV1 (L) FVC (L) FEV6 (L) FEF2575 (L/s) FEV1/FVC Measured oximetry parameters:
Mean saturation percentage of oxygen in the blood during the test Average heart rate during the test SpO2 (%) BPM (heartbeats per minute) Ver. 1.5 User Manual Page 27 di 33 Spirobank Oxi ENGLISH Additional measured spirometry parameters in the F/V version only:
PIF (L/min) FIV1 (L) FIVC (L) Peak Inspiratory Flow Inspiratory Volume in one second of the inspiration Forced Inspiratory Vital Capacity Expiratory Volume in the initial 0,5 seconds of the test FEV05 (L) Expiratory Volume in the initial 0,75 seconds of the test FEV075 (L) Expiratory Volume in the initial 2 seconds of the test Expiratory Volume in the initial 3 seconds of the test Maximum Flow at 25% of FVC Maximum Flow at 50% of FVC Maximum Flow at 75% of FVC Extrapolated Volume Forced Expiratory Time Time to achieve 90% of the PEF FEV2 (L) FEV3 (L) FEF25 (L/s) FEF50 (L/s) FEF75 (L/s) EVol (mL) FET (s) PEF Time (ms) Others technical specifications Measuring system Spirometry principle of measurement Oximetry principle of measurement Max. peak flow Volume max Volume accuracy (ATS 2019) Peak flow accuracy Dynamic resistance at 12 l/s SpO2 measurement range SpO2 accuracy Bi-directional turbine (rotary blade) Infrared interruption Reflective LED sensor, with double wavelength PEF 960 l/min (16 l/s) FEV1, FEV6, FVC: 10l The greater value between 2.5% and 0.05 l The greater value between 10% and 20 l/min ( 0,33 l/s)
<0.5 cm H2O/L/s 70%-100%
1.9%
Ver. 1.5 User Manual Page 28 di 33 Cardiac frequency measurement range BPM accuracy Communication interface Electrical power supply Measurements Weight Type of electrical protection Level of electrical protection IP protection level Applicable standard Conditions of use Conservation conditions Transport conditions Operating conditions LED sensor wavelengths Spirobank Oxi ENGLISH 30-200 BPM 3%
Bluetooth SMART (5-Ready) 2 x 1.5V AAA alkaline batteries Main body 109x49x21 mm 60.7 g (including batteries) Internal power supply BF type part applied IP22 ATS/ERS Guidelines: 2005, 2019 update ISO 26782: 2009 ISO 23747: 2015 EN ISO 14971: 2019 ISO 10993-1: 2018 2011/65/UE Directive EN ISO 15223:2016 IEC 60601-1:2005 + A1: 2012 EN 60601-1-2: 2015 EN IEC 60601-1-6: 2010+Amd2013 EN 60601-1-11: 2015 ISO 80601-2-61: 2017 IEC 62304:2006/A1:2015 Device for continuous use Temperature: MIN -25C, MAX +70C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN -25C, MAX +70C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN +5 C, MAX +40 C Humidity: MIN 15% UR; MAX 93% UR Red light: 660 nm**
Infrared light: 880 nm**
Ver. 1.5 User Manual Page 29 di 33 Spirobank Oxi ENGLISH Mean maximum optical power output in 1.2 mW
** this information can be useful for the physician. Warning: Life time - the expected life time (or service life) of the device if properly used and stored is 5 years. 8. BLUETOOTH WIRELESS TECHNOLOGY INFORMATION Bluetooth compliance:
Operating Frequency:
Max Output Power:
Operating Range:
Network Topology:
Operation:
Antenna type:
Modulation Technology:
Modulation Type:
Data Rate:
Data latency:
Data Integrity:
Bluetooth 5-Ready from 2.4 GHz to 2.4835 GHz TX: 0 dBm; 1 mW radius of 10 metres (range of vision) Star - bus Server Antenna integrated in the module FHSS GFSK 1 Mbit/second 7 40 ms Adaptive frequency hop, Lazy Acknowledgement, CRC at 24 bit, message integrity check at 32-bit Sending data packages every 60 ms. It includes 3 control bytes to enable the host to detect any missing packages and the device to re-transmit them. This device uses Bluetooth Smart technology for wireless communications, so as to provide reliable communication in electrically noisy environments and transmit data packages every 60 ms. It includes 3 control bytes to enable the host to detect any missing packages and the device to re-transmit them. In the event of the connection being interrupted, the app Format:
Quality of Service:
Ver. 1.5 User Manual Page 30 di 33 Spirobank Oxi ENGLISH Bluetooth Profiles supported:
Authentication and Encryption:
Encryption Key Size:
changes status, from connected to not-connected, and becomes immediately available for a connection. Profile based on GATT Supported AES 128 bit with Counter Mode CBC-MAC and application level defined by the user The Bluetooth word mark and logo are registered trademarks owned by Bluetooth SIG, Inc. Communication at radiofrequency (RF) 8.1 This device conforms to the FCC standards (United States Federal Communications Commission) and to the international standards on electromagnetic compatibility. The following information is provided in accordance with the FCC (Federal Communications Commission) rules. The device complies to Part 15 of the FCC Standards. Operation is subject to the following conditions: (1) This device must not cause damaging interference and (2) this device must accept any interference received, including the interference which might cause an undesired functioning. The device does not interfere with the radiofrequency signals transmitted from external sources. The FCC standards were conceived to provide reasonable protection against excessive radiofrequency interference and to prevent malfunctioning of the device caused by undesired electromagnetic interference. 8.2 Interference in radiofrequency (RF) caused by other wireless devices The majority of consumer electronic devices on the same frequency band as used by Spirobank Oxi can prevent the uploader or the mobile device from receiving the data. This equipment has been tested and conforms to the limits for Class B digital devices in accordance with Part 15 of the FCC Standards. These limits are conceived to provide reasonable protection from damaging interferences in a residential context. 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. It is not however possible to guarantee that these interferences will Ver. 1.5 User Manual Page 31 di 33 not occur in a particular installation. The device causes damaging interference with the reception of radio or tv signals, which can arise by switching the equipment on or off;
the user is advised to try to correct the interference by increasing the distance separating the equipment from the receiver. Spirobank Oxi ENGLISH Ver. 1.5 User Manual Page 32 di 33 Spirobank Oxi ENGLISH 9. WARRANTY TERMS Spirobank Oxi is guaranteed for:
12 months in the case of professional use (physician, hospital structure, etc.) 24 months if the product is bought directly by the final user. The warranty period is effective from the date of purchase, which must be proven by an invoice or sales receipt. The device must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to the manufacturer. This warranty covers the repair or the replacement (at the discretion of the manufacturer) of the product or of the defective parts without charge for the parts or for the labour. All batteries and other consumable parts, including the turbine flow meter, are specifically excluded from the terms of this guarantee. The product warranty shall not apply, at the discretion of the manufacturer, in the following cases:
Improper installation, improper operation of the device, or if the installation does not comply with local technical or safety regulations in the Country where the device was purchased Use of the product for purposes other than those provided or failure to follow instructions Repair, adaptation, modification or tampering by personnel not authorised by the manufacturer Damage caused by lack of or incorrect maintenance Damage caused by anomalous physical or electrical stresses Damage caused by defective electric supply or the equipment to which the product has been connected Serial number altered, deleted, 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 the manufacturer. For details of these centres please contact either your local supplier or the manufacturer. Customer shall be responsible for all transport, customs and delivery charges regarding the goods. Each product, or accessory, sent in for repair must be accompanied by a clear and detailed explanation of the fault. Forwarding to the manufacturer requires the written permission of the manufacturer himself. MIR Medical International Research reserves the right to replace the product or bring modifications deemed necessary to it. Ver. 1.5 User Manual Page 33 di 33
1 | Users Manual | Users Manual | 869.51 KiB | February 24 2022 |
Smart One Oxi English Oxi BEFORE USING THIS DEVICE READ ALL INFORMATION CONTAINED IN THIS USER MANUAL. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR SPIROMETER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. IF THE INSTRUCTIONS ARE NOT CLEAR:
USA:
Call MIR USA Tel + 1 (262) 565 - 6797 ; Fax + 1 (262) 364 - 2030, Monday to Friday 8 AM to 5 PM (central time), or contact us at mirusa@spirometry.com, or write to us at MIR USA, 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 to us at MIR Via del Maggiolino 125, 00155 Rome, Italy. User Manual Rev 1.8 Issue Date February 04th, 2022 Oxi is registered trademark of MIR S.r.l. MEDICAL INTERNATIONAL RESEARCH 0476 Rev.1.8 User Manual Page 1 of 35 Smart One Oxi English Date Measurements FEV1 PEF Recommendation Doctor Reserved for the physician or other licensed healthcare professional to write your positive flow rates and to provide specific interventions he/she recommends for ranges of decreased flow rates. Rev.1.8 User Manual Page 2 of 35 Smart One Oxi English CONTENTS 7. 7.1 7.2 7.3 6.1 6.2 6.3 6.4 INDICATIONS FOR USE ................................................................................................. 5 1. IMPORTANT INFORMATION CONCERNING INTENDED USE ......................................... 5 2. 3. DETERMINING YOUR PEF BASELINE VALUES................................................................ 6 4. WARNINGS AND PRECAUTIONS ................................................................................... 8 HOW TO START TO USE THE MIR SMART ONE APP ..................................................... 9 5. HOW SMART ONE OXI WORKS .................................................................................. 10 6. Control of registrations .................................................................................... 12 Self-measurement of PEF and FEV1 values ...................................................... 13 Performing the oximetry test .......................................................................... 16 How to interpret the results ............................................................................ 17 IMPORTANT SAFETY WARNINGS ............................................................................... 19 Data security warnings .................................................................................... 20 Warnings for use in electromagnetic environments ........................................ 20 Notes on FCC certification ............................................................................... 21 8. MAINTENANCE AND CLEANLINESS ............................................................................ 22 Cleaning and disinfection of the turbine .......................................................... 22 Cleaning and disinfection of the mouthpiece .................................................. 23 Cleaning of the device ..................................................................................... 23 Replacing batteries .......................................................................................... 23 9. ERROR MESSAGES ..................................................................................................... 24 10. TROUBLESHOOTING .................................................................................................. 26 11. ACCURACY and reliability ........................................................................................... 27 12. LABELS & SYMBOLS ................................................................................................... 29 13. TECHNICAL SPECIFICATIONS ...................................................................................... 30 Information on Bluetooth Wireless technology ......................................................... 33 14. Communication at radiofrequency (RF) ........................................................... 34 Interference in radiofrequency (RF) caused by other wireless devices ............ 34 15. WARRANTY TERMS .................................................................................................... 35 8.1 8.2 8.3 8.4 14.1 14.2 Rev.1.8 User Manual Page 3 of 35 Smart One Oxi English Before connecting SMART ONE OXI 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 it looks damaged, do not use the device and return it directly to request replacement. If there is, do not use the device and send it straight back for replacement. INCLUDES Spirometer for peak flow and FEV1 Plastic mouthpiece 2 AAA batteries User Manual Keep the original packaging! In the event of a problem with your product, 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 Website: www.spirometry.com Fax + 1 (262) 364 2030 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. The manufacturer cannot be held responsible for any damage caused by users failing to follow the instructions contained in this manual. Rev.1.8 User Manual Page 4 of 35 Smart One Oxi English INDICATIONS FOR USE 1. Smart One Oxi spirometer and pulse oximeter is intended to be used by a physician or by a subject under the instructions of a physician or paramedic to assess lung function. The device is designed for children of over five years of age, adolescents and adults, and can be used at home, in a factory, pharmacy, hospital or medical surgery. 2. IMPORTANT INFORMATION CONCERNING INTENDED USE PEF is the maximum speed a person can blow air out of the lungs after taking a very deep breath. 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. SpO2 is the percentage of oxygen saturation in the blood. BPM is the heart rate. WARNING: WHEN SMART ONE OXI 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 very important to watch for changes from one measurement to the next, and to follow the actions you have to take according to the plan of action provided to you by your physician or other licensed healthcare professional. If you have respiratory 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 OXI 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. Rev.1.8 User Manual Page 5 of 35 Smart One Oxi English 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 OXI meter. They also will explain how your PEF and FEV1 measurements help them monitor your lung function and how well treatments are working. 3. DETERMINING YOUR PEF BASELINE VALUES 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. The importance of any changes in airflow from one measuring to the next depends upon how much they are different from the 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, gender 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, gender, and origin. MIR SMART ONE app calculate the predicted value 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. Rev.1.8 User Manual Page 6 of 35 Smart One Oxi English PEF table Male (L/min) Height (cm) 120 130 140 150 160 170 180 190 200 5 128 175 221 268 315 362 409 455 502 10 178 224 271 318 365 412 458 505 552 15 227 274 321 368 415 461 508 555 602 20 277 324 371 418 464 511 558 605 652 25 265 321 378 434 490 547 603 660 716 30 254 311 367 423 480 536 593 649 705 35 244 300 357 413 469 526 582 639 695 40 233 290 346 402 459 515 572 628 684 45 223 279 336 392 448 505 561 618 674 50 212 269 325 381 438 494 551 607 663 55 202 258 315 371 427 484 540 597 653 60 191 248 304 360 417 473 530 586 642 65 181 237 294 350 406 463 519 576 632 70 170 227 283 339 396 452 509 565 621 75 160 216 273 329 385 442 498 555 611 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 Female PEF values (l/min) Height (cm) 120 130 140 150 160 170 180 190 200 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 30 264 293 323 352 381 411 440 470 499 35 256 286 315 344 374 403 433 462 491 40 249 278 308 337 366 396 425 455 484 45 241 271 300 329 359 388 418 447 476 50 234 263 293 322 351 381 410 440 469 55 226 256 285 314 344 373 403 432 461 60 219 248 278 307 336 366 395 425 454 65 211 241 270 299 329 358 388 417 446 70 204 233 263 292 321 351 380 410 439 75 196 226 255 284 314 343 373 402 431 80 189 218 248 277 306 336 365 395 424 85 181 211 240 269 299 328 358 387 416 E G A E G A Rev.1.8 User Manual Page 7 of 35 Smart One Oxi English 90 174 203 233 262 291 321 350 380 409 WARNING: INDEPENDENTLY OF THE METHOD CHOSEN BY YOUR DOCTOR OR OTHER LICENSED HEALTH PROFESSIONAL, THE PATIENT MUST CLEARLY UNDERSTAND THE MEANING OF THE BASELINE VALUE AND HOW IT INFLUENCES THE TREATMENT PLAN. IF IN DIFFICULTY REGARDING ESTABLISHING YOUR OWN BASELINE VALUE, ASK FOR HELP FROM YOUR PHYSICIAN OR ANOTHER LICENSED HEALTH PROFESSIONAL. 4. 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 FLOWMETER FOR MEASURING PEF AND FEV1 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. TO INTERPRET THE MEANING AND SIGNIFICANCE OF A MEASUREMENT TAKEN USING SMART ONE OXI AND TO DECIDE ON AN APPROPRIATE PLAN OF ACTION, BE SURE TO CONSULT A HEALTHCARE PROFESSIONAL, ALSO IN VIEW OF THE FACT THAT THE DEVICE IS NOT EQUIPPED WITH ALARMS. APPROPRIATE DIAGNOSIS AND TREATMENT CAN ONLY BE PROVIDED BY A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THE PLAN OF ACTION WILL INDICATE WHICH ACTION IS TO BE TAKEN WHEN THERE ARE CHANGING MEASUREMENTS. SELF-MEASUREMENT MEANS CHECKING, NOT DIAGNOSING OR CHOOSING A TREATMENT. IF ANY EVENT OCCURS SHOW YOUR MEASUREMENTS TO YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. THEY WILL ALSO EXPLAIN WHICH ARE THE NORMAL VALUES FOR YOU. INDEPENDENTLY OF YOUR VALUES, IF YOU ARE SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT YOUR PHYSICIAN OR A LICENSED HEALTHCARE PROFESSIONAL. Rev.1.8 User Manual Page 8 of 35 Smart One Oxi English TO OBTAIN ACCURATE MEASUREMENTS, CAREFULLY FOLLOW THE INSTRUCTIONS. IF YOU CANNOT OBTAIN A VALUE, CONTACT YOUR HEALTHCARE PROFESSIONAL. ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USING THE SMART ONE BEFORE RELYING ON ANY MEASUREMENT. MODIFYING THE PLAN OF ACTION OR THE BASELINE VALUES MUST BE CARRIED OUT ONLY FOLLOWING INDICATIONS OF YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. SPEAK WITH YOUR PHYSICIAN BEFORE PROCEEDING. NEVER CHANGE DRUG DOSES WITHOUT FIRST AGREEING THEM WITH YOUR PHYSICIAN. THE DEVICE SHOULD NOT BE USED BY MORE THAN ONE PERSON. IF MORE THAN ONE PERSON WISHES TO USE IT, THE MEASUREMENT OF EACH PERSON SHOULD BE ATTRIBUTED CORRECTLY AND BOTH THE TURBINE AND THE MOUTHPIECE MUST BE CLEANED CAREFULLY FOLLOWING EACH USE UNLESS MORE THAN ONE MOUTHPIECE/TURBINE IS AVAILABLE. IF ANOTHER PERSON INTENDS TO USE THE DEVICE EXCLUSIVELY, THE PREVIOUSLY SAVED DATA ON THE MIR SMART ONE APP MUST BE DELETEDAND A NEW BASELINE MEASUREMENT WILL HAVE TO BE ESTABLISHED ACCORDING TO WHAT IS ESTABLISHED BY THE PHYSICIAN OR THE LICENSED HEALTHCARE PROFESSIONAL. 5. HOW TO START TO USE THE MIR SMART ONE APP Follow the instructions in the Maintenance section for correct battery insertion. Before connecting SMART ONE OXI to a smartphone, install the MIR SMART ONE free app, which you can download from the Apple Store (for iPhone and iPad) or Play Store (for Android devices). Launch the MIR SMART ONE OXI app and proceed with the following steps. These are one-off steps that do not need to be repeated each time the app is accessed. a) authorisation for data exchange with the Health app, already installed in the smartphone. The user can decide whether or not to allow Rev.1.8 User Manual Page 9 of 35 Smart One Oxi English the following data to be written to the Health application: height, weight, PEF and FEV1 the following data to be read from the Health application: height, weight, date of birth, gender. Authorisation for each parameter can be given or denied. b) entering your own personal data: date of birth, origins, weight, height, gender. The MIR SMART ONE OXI will use this data to calculate the baseline values of the PEF and to assign a colour indicator to your test (green, yellow or red). Consult the CALCULATION OF BASELINE VALUES section for a full detailed explanation of the baseline value. If the data is not entered a warning message appears. The connection between SMART ONE OXI and your smartphone is automatic. To check whether there is a connection, read the messages from the application. 6. HOW SMART ONE OXI WORKS SMART ONE OXI is an electronic device for domestic use which precisely measures your PEF
(Peak Expiratory Flow) and the FEV1 (maximal expiratory volume in the 1st second, VEMS). The device also measures the parameters related to the oximetry test in particular the SpO2 and the BPM. The PEF is the maximal expiratory volume with which the air can be expelled from the lungs after having drawn breath in deeply, while the FEV1 is the maximal expiratory 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 MEASUREMENT OF PEF AND FEV1 AT HOME?
The first portable mechanical measuring instrument for calculating PEF was introduced by B. Wright in 1959. The wide use made of this device for monitoring children above five years of age and adults made this instrument popular for tracing the respiratory conditions of patients with asthma and other pulmonary dysfunctions. Electronic measuring instruments, economical, small, portable and easy to use for assessing respiratory dysfunction are now widely available. These offer numerous advantages, including the possibility of recording the PEF and FEV1, and recording and transferring the data to a physician or another licensed healthcare professional. Rev.1.8 User Manual Page 10 of 35 Smart One Oxi English SMART ONE OXI emits a warning signal if the test is not correctly carried out, for example if instead of blowing as much as possible exhalation is too slow. This is a further objective advantage with respect to a mechanical spirometer which does not provide any such signalling. The PEF and FEV1 are measured during the same exhalation. When the test is correctly carried out, the PEF is measured for 0.10-0.15 seconds from the start of exhalation, while the FEV1 is measured for 1 second exactly from the start of the exhalation. According to the best tests of effectiveness, taken from among numerous scientific studies, research documents and expert clinicians, both the PEF and FEV1 are good indicators of the respiratory mechanics in conditions of health and illness and can indicate how the breathing functions and can help to verify whether there have been alterations to the respiratory flow. The constant measurement of PEF and FEV1 provides a proof of progression of an illness. The GUIDE FOR MANAGEMENT AND PREVENTION OF ASTHMA, published in 2016 by GINA Global Strategy for Asthma Management and Prevention) states:
To obtain training for effective self-management of asthma the following is necessary:
Self-monitoring of the symptoms and/or the lung function A written plan of action for asthma Periodic medical checks The above indicates that when self-managing asthma the conditions of your lungs can effectively be monitored on the basis of the plan of action written out by a physician or a licensed healthcare professional. WARNING: TO INTERPRET THE MEANING AND IMPORTANCE OF A MEASUREMENT OBTAINED USING SMART ONE OXI AND DECIDING AN APPROPRIATE PLAN OF ACTION IT IS NECESSARY TO CONSULT A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL. The SMART ONE OXI connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the MIR SMART ONE OXI application has been installed on the smartphone. Each PEF and FEV1 measurement is transferred by the device to the smartphone so as to be displayed. The use of the coloured PEF indicator (green, yellow or red) is recommended as indicated by your physician or another licensed healthcare professional. These are the professionals who will help you to accurately run the test and advise you as to the actions to undertake when measuring decreasing values. Rev.1.8 User Manual Page 11 of 35 Smart One Oxi English WARNING: WHEN SMART ONE OXI 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 PEF and FEV1 value usually means that the air is easily accessing the lungs. When there is an asthma attack the air can no longer easily circulate in the lungs and lower measurements are the outcome. It is usually recommended to carry out the measurements as indicated by the licensed healthcare professionals. SMART ONE OXI should be used also when respiratory difficulty symptoms are manifested, to help the person and the physician or licensed healthcare professional to determine the severity of the respiratory symptoms and understand how the treatment is working. Consult your physician or other licensed healthcare professional about the times and frequency of use of the SMART ONE OXI spirometer and pulse oximeter. Control of registrations 6.1 The MIR SMART ONE OXI app keeps a trace of the higher PEF and FEV1 values read both for the morning and evening session, complete with date and time of reading. The points between two readings are connected to one another to form a graph of the trend. This recording is destined in future to become an important part of the plan of action for every sufferers asthma. The MIR SMART ONE can transfer the data measured to the family physician or another licensed healthcare professional. If correctly used, SMART ONE OXI helps patients and physicians or licensed health personnel to monitor asthma and other lung pathologies so as to offer the best treatment. The subsequent revision of the measured data enables patients and healthcare professionals to more precisely check the respiratory complaint present in order to provide the most suitable personalised treatment. As the smartphone automatically memorises hundreds of readings, the device can be taken along to a meeting with your physician or healthcare professional so that a large quantity of readings can be viewed. Rev.1.8 User Manual Page 12 of 35 Smart One Oxi English 6.2 Self-measurement of PEF and FEV1 values BEFORE USING THIS DEVICE READ ALL INFORMATION CONTAINED IN THIS USER MANUAL. IF YOU DO NOT UNDERSTAND THESE INSTRUCTIONS OR IF YOU HAVE QUESTIONS ABOUT YOUR SPIROMETER AND ITS USE CONSULT YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL. IF THE INSTRUCTIONS ARE NOT CLEAR:
USA:
Call MIR USA Tel + 1 (262) 565 - 6797 ; Fax + 1 (262) 364 - 2030, Monday to Friday 8 AM to 5 PM
(central time), or contact us at mirusa@spirometry.com, or write to us at MIR USA, 5462 S. Westridge Drive, New Berlin, WI 53151 USA. 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 Rome, Italy. ASK YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USING THE SPIROMETER. THIS HELPS TO ENSURE CORRECT USE OF THE INSTRUMENT. INDEPENDENTLY OF THE MEASUREMENT VALUES ON YOUR SPIROMETER, IF YOU ARE SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT AND FOLLOW THE INDICATIONS OF YOUR PHYSICIAN OR A LICENSED HEALTHCARE PROFESSIONAL. IF YOU CANNOT OBTAIN A VALUE, CONTACT YOUR PHYSICIAN IMMEDIATELY. SMART ONE OXI must be cleaned as illustrated in the MAINTENANCE AND CLEANLINESS section prior to starting to use it and then periodically. To perform a measurement:
Running the MIR SMART ONE app on a smartphone Press the START icon Wait for the Bluetooth connection Rev.1.8 User Manual Page 13 of 35 Push the turbine into the slot until it stops Turn the turbine clockwise until it stops Smart One Oxi English 1 3 Insert the mouthpiece at a depth of at least 0.5 cm in the turbine socket. 2 4 The SMART ONE is ready to use. Hold SMART ONE OXI in your hand as if it were a mobile telephone and ensure is not obstructed by your hand. turbine that the Rev.1.8 User Manual Page 14 of 35 Insert the mouthpiece between your teeth and close your lips about the mouthpiece. Ensure that your lips grip the mouthpiece forcefully. Smart One Oxi English the Start Test Tap icon under SPIROMETRY on the MIR SmartOne App. 5 6 that might turbulence To prevent otherwise affect the results do not put your tongue in the mouthpiece. Do not bend your neck. It is best to do the test standing or sitting upright. (it makes no difference to the test results). 6 7 Slowly inhale, taking in as much air as possible. Blow with maximum force possible until the result appears on the smartphone screen. These are your PEF and FEV1 values. N.B.: Avoid exhaling slowly and at length As each test must consist of three individual tests, repeat steps from 4 to 7 twice more. Each session lasts 5 minutes. SMART ONE OXI will save the highest value of the three individual tests only if the highest in the session presently open. Rev.1.8 User Manual Page 15 of 35 Smart One Oxi English Warning: For monitoring elderly patients and children and differently-able persons, the supervision of an adult is required. The device shows an error message if the exhalation start-up was not satisfactory and if the exhalation did not finish satisfactorily. 6.3 To perform the test correctly, follow the instructions below. Performing the oximetry test Place the thumb of the hand holding the SMART ONE OXI on the sensor as in the image Tap the "Start Test" icon under OXIMETRY on the SMART ONE application. 2 During the test the perfusion reported with a bar indicator. Minimum duration of a test is 30 seconds. index is 1 3 Rev.1.8 User Manual Page 16 of 35 The device displays an error message if the sensor is not functioning and if the finger is not positioned on the sensor. If the signal detected is not of sufficient quality to estimate the oximetry parameters; the parameters are not displayed. Smart One Oxi English How to interpret the results 6.4 For the spirometry measurements, three individual tests are made in each test, after which the MIR SMART ONE app compares the values with all those obtained in the preceding 5 minutes. For the session PEF values it is therefore automatically selected, saved and compared with the baseline value. The app shows a graphic sign (green, yellow or red) which is then displayed as a coloured circle about the PEF value obtained. The meaning of the traffic lights is displayed in the following table. Rev.1.8 User Manual Page 17 of 35 COLOUR Green RESULT Above 80% of baseline MEANING OK the Yellow Above 50% and below or identical to 80% of the baseline Warning Red Below or 50% of the baseline identical to Danger Smart One Oxi English in carrying out ACTION Respiratory conditions seem to be under control. The treatment is working. Process with normal activities. Caution the operations Refer to the plan of action set out by your physician or healthcare by professional to establish which action is to be undertaken. Medical alert. Seek immediate medical help. Act as agreed with your physician or other licensed healthcare professional. licensed a For the oximetry measurements, each test saved in the memory appears in the Results section, which contains the value of SpO2, the value of cardiac frequency, the date and time of the test and any notes. WARNING: ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL TO WATCH YOU USING THE SMART ONE OXI BEFORE RELYING ON ANY MEASUREMENT. WARNING: 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. WARNING: THE PLAN OF ACTION PROVIDED BY YOUR PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL WILL INDICATE WHICH ACTION TO TAKE IN A CASE IN WHICH THERE ARE RELEVANT VARIATIONS IN VALUES. WARNING: INDEPENDENTLY OF YOUR VALUES, AND EVEN WHERE THE DEVICE IS NOT INDICATING ALARMS, IF YOU ARE SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA, CONTACT YOUR PHYSICIAN OR LICENSED HEALTHCARE PROFESSIONAL. Rev.1.8 User Manual Page 18 of 35 Smart One Oxi English 7. IMPORTANT SAFETY WARNINGS Warning: 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. For monitoring elderly patients and children above 5 years of age, and differently-
able persons, the supervision of an adult is required. 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. Check that no impurities or foreign bodies, such as skin or hairs, have accumulated inside the turbine. Any modifications not expressly approved by this Company could compromise use of the device by the user. Check that there are no elements obstructing the oximetry sensor. Any modifications not expressly approved by this Company could compromise use of the device by the user. Do not let the device fall and do not treat it with lack of care. Avoid strong vibrations. 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 chemical substances. Use and store the device in compliance with the environmental conditions specified in the Technical Specifications. If the device is exposed to environmental conditions other than those specified, it might 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. If problems arise, do not try to repair the device yourself. Rev.1.8 User Manual Page 19 of 35 Smart One Oxi English Data security warnings 7.1 The smartphone stores the users 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 of data in memory by unauthorized persons Loss of data in memory The integrity check of the data is made automatically and in case of transmission error Inability to use smartphone for communications 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 Check that the email address you are to send your test results to is the correct one After transmitting the data call your physician to confirm that it has been received 7.2 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. This electromagnetic interference could cause the medical device to malfunction, such as an accuracy of measurement that is lower than the declared one, and create a potentially unsafe situation. Warnings for use in electromagnetic environments SMART ONE OXI complies with EN 60601-1-2:2015 on electromagnetic compatibility (EMC for electro-medical devices) for both immunity and emissions. Rev.1.8 User Manual Page 20 of 35 Smart One Oxi English For the device to function properly, however, the following precautions must be taken:
Make sure that the SMART ONE OXI and the smartphone on which the app is installed are no more than 2 metres apart. Do not use SMART ONE OXI near other devices (computers, cordless phones, cell phones, etc.) that generate strong electromagnetic fields. Keep the above-described equipment at a distance of at least 30 centimetres. If a use under lower distances is necessary, SMART ONE OXI and the other devices should be kept under observation to verify that they are functioning normally. Notes on FCC certification 7.3 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference 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 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:
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Increase the separation between the equipment and receiver. Reorient or relocate the receiving antenna. Consult the dealer or an experienced radio/TV technician for help. Rev.1.8 User Manual Page 21 of 35 Smart One Oxi English 8. MAINTENANCE AND CLEANLINESS SMART ONE OXI is a device that requires little maintenance. The following operations must be carried out regularly:
cleaning and disinfection of the turbine cleaning and disinfection of the mouthpiece cleaning of the device replacing batteries At each change of patient the turbine must be cleaned and disinfected. 8.1 Cleaning and disinfection of the turbine To avoid irreparable damage to the turbine, do not use detergents including alcohol or oily substances and do not immerse the turbine in water or solutions at high temperatures. Never try to sterilise the turbine in boiling water. Never try to clean the turbine under a direct jet of water or other liquids. If you do not have liquid detergents available, the turbine must be washed at least with clean water. Correct functioning of the turbine is guaranteed only if it is clean and free of foreign bodies which interfere with 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. Rev.1.8 User Manual Page 22 of 35 Smart One Oxi English To clean the turbine, pull it out of the SMART ONE OXI socket by turning it counterclockwise and simply pulling it out. To make it easier to pull out, push the base of the turbine gently with a finger. Weekly cleaning is recommended. Immerse the turbine flowmeter in warm soapy water and shake the turbine for 2-3 minutes. The hand dishwashing detergent that was tested includes the following ingredients: Aqua, coco glucoside, myristyl glucoside, lauryl glucoside, sodium chloride, sodium gluconate, sodium citrate, allyl caproate, ethylene brassylate, methyldihydrojasmonate). Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel. Store in a clean, dry place in your home. After cleaning, insert the turbine in the socket in the direction indicated by the closed padlock symbol printed on the SMART ONE OXI device To insert the turbine correctly, push it down and turn clockwise until it stops, to make sure it is fully inserted into the plastic housing. Cleaning and disinfection of the mouthpiece 8.2 Make sure to clean the mouthpiece after each use. To clean the mouthpiece, simply pull it apart from the turbine. Using the same method as for the turbine, immerse the mouthpiece in warm soapy water and shake the mouthpiece for 2-3 minutes. Rinse in clean water and shake gently to remove any excess water. Allow to 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. Cleaning of the device 8.3 Clean the device once a day using a clean damp cloth. To clean, wipe the devices 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 Do not use alcoholic solutions. Replacing batteries 8.4 The device continuously monitors the battery level. A message on the smartphone display alerts the user when the device battery is low. When the batteries are completely charged the device has an operational span of five years or 1000 tests, whichever comes first. Rev.1.8 User Manual Page 23 of 35 Smart One Oxi English Used SMART ONE OXI batteries should only be disposed of in special containers or preferably returned to the distributor dealer of the device or to a special collection centre. In any case, all applicable local regulations must be complied with. Remove the battery cover on the back of the SMART ONE OXI. Remove the two batteries and replace them with two new ones, following the polarity as indicated by the symbols in the compartment. 2 Reposition the battery cover. 1 3 9. ERROR MESSAGES If you encounter any problems when using the SMART ONE OXI, a message will appear on the smartphone display to warn of the malfunction. Rev.1.8 User Manual Page 24 of 35 MESSAGE Bluetooth Storage conditions Bluetooth is deactivated Battery low It appears that no email account has been configured. The oximetry test has not been stored When the SMART ONE OXI batteries are below 15%
The user wants to share the results of the tests, but has not configured an e-
mail account on their smartphone. The test lasted less than 30 seconds or the average finger value the pressure was unsati-
sfactory of Smart One Oxi English SOLUTION To perform measurements with the device, you must activate Bluetooth on the smartphone. Exit the app and activate the Bluetooth from the smartphone settings menu. Replace batteries Set an email account from the smartphone settings menu. the SMART ONE OXI the following Repeat the test instructions given on the display and wait at least 30 seconds for the test to complete. The test lasts a maximum of 60 seconds after which it is automatically interrupted Rev.1.8 User Manual Page 25 of 35 Smart One Oxi English 10. TROUBLESHOOTING If you have an unusually low reading, it could mean that your SMART ONE OXI flowmeter is broken, or it could mean that the reading is accurate and your asthma is getting worse. Check that the flowmeter is not broken. Scrupulously follow the instructions to obtain accurate results. If the flowmeter is not broken, follow the instructions in your plan of action relating to low readings and consult your physician or another licensed healthcare professional. For any question relating to the use of the device, contact your physician or other licensed healthcare professional, or contact MIR USA, Inc. Freephone no: 8444647872. USA:
Call MIR USA 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, 5462 S. Westridge Drive New Berlin, WI 53151 - USA EUROPE and WORLDWIDE:
Call MIR +39 06 22754777, from Monday to Friday, from 8 am to 5 pm (GMT+1), or contact us at mir@spirometry.com, or write TO us at MIR Via del Maggiolino 125, 00155 Roma, Italy. If problems occur when using the device, the following points should be checked. MALFUNCTIONING SMART ONE OXI cannot connect with the smartphone Storage conditions The Bluetooth connection is not working properly The turbine may be dirty The test results are unreliable The test was performed wrongly SOLUTION Look for SMART ONE OXI on the list of recognized devices. For correct use, the smartphone needs Bluetooth version 4.0 or higher Clean the turbine as described in the Maintenance section. If necessary, replace the turbine with a new one. If necessary contact the manufacturer. the test, Repeat directions on the screen. Avoid sudden movements when finish exhalation. Speak to your physician about the measured values following you the Rev.1.8 User Manual Page 26 of 35 Smart One Oxi English MALFUNCTIONING The oximetry test has not been stored Storage conditions The turbine has not been inserted properly The test lasted less than the 30 seconds or average value of the pressure was finger unsatisfactory SOLUTION Insert the turbine from the front part of the device by pushing it downwards until it stops, and then rotating it in a clockwise direction Repeat the test instructions given on the display and wait at least 30 seconds for the test to complete. following the 11. ACCURACY AND RELIABILITY For the spirometry measurements, the device complies with the requisites of the following standards:
Standardisation of the spirometry (ATS 2005, 2019 update) ISO 23747: 2015 ISO 26782: 2009 Volume max Volume accuracy: the higher value between Max. peak flow Peak flow accuracy: highest value between 10 I 2.5% and 0.05 l (ATS 2019) 960 l/min (16 l/s) 10% and 20 l/min (0.33 l/s) Time zero At the point of peak expiratory flow (PEF), a tangent is drawn with a slope equal to PEF and its intersection on the abscissa defines TIME ZERO. The back extrapolated volume is the volume of gas that has already been exhaled at the point of TIME ZERO as defined by back extrapolation. The method to determine the time elapsed by TIME ZERO, t0, is given by the following equation:
Rev.1.8 User Manual Page 27 of 35 Smart One Oxi English Time zero = tPEF - (VPEF/PEF) Where PEF is the peak expiratory flow;
tPEF is the elapsed time at PEF;
VPEF is the expired volume at PEF For the oximetry measurements, the device conforms to the requisites of the following standard:
ISO 80601-2-61:2017 Medical electrical equipment particular requirements for basic safety and essential performance of pulse oximeter equipment Range (SpO2) 70-100 %
70-80 %
80-90 %
90-100 %
Arms (%) 1.90 2.32 1.71 1.43 The Arms (Accuracy Root Mean Square), as mentioned in the above-cited standard, represents the accuracy of the device in terms of mean quadratic error of each SpO2 measurement, obtained by pulse oximetry, in relation to the respective reference value of SaO2, obtained by co-oximetry. The listed ranges show the different saturation intervals of oxygen for which the accuracy has been calculated. The accuracy of the device cannot be assessed with a tester. Rev.1.8 User Manual Page 28 of 35 Smart One Oxi English 12. LABELS & SYMBOLS The symbols are described in the table below SYMBOL Model:
SN DESCRIPTION Description of product Series number of the device 0476 IP22 FCC ID Manufacturers name and address This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC. In accordance with IEC 606011 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/EU 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 for collection of waste from electrical and electronic equipment. 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. Indicates the degree of resistance to liquids. The device is protected against falling drops of water if it is arranged at up to 15 from the vertical. The symbol is used to identify products containing RF transmitters. Identification showing traceability in compliance with FCC Standards Instructions for use symbol. Read this manual carefully before using the medical device Production date Rev.1.8 User Manual Page 29 of 35 Smart One Oxi English SYMBOL DESCRIPTION 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 Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed SMART ONE OXI complies with the Essential Requirements of Directive 93/42/EEC on Medical Devices. This is based on CE Certificate no. MED 9826 issued by Kiwa Cermet, notified Organism no. 0476. 13. TECHNICAL SPECIFICATIONS Peak Expiratory Flow Maximum Expiratory Volume in 1st second Mean saturation percentage of oxygen in the blood during the test Average heart rate during the test Measuring system Spirometry principle of measurement Oximetry principle of measurement Max. peak flow Volume max Volume accuracy (ATS 2019) Peak flow accuracy Dynamic resistance at 12 L/s SpO2 measurement range PEF (l/min) FEV1 (l) SpO2 (%) BPM (heartbeats per minute) Bi-directional turbine (rotary blade) Infrared interruption Reflective LED sensor, with double wavelength PEF 960 l/min (16 l/s) FEV1 10l The greater value between 2.5% and 0.05 l The greater value between 10% and 20 l/min
( 0.33 l/s)
<0.5 cm H2O/L/s 70%-100%
Rev.1.8 User Manual Page 30 of 35 Smart One Oxi English SpO2 accuracy Cardiac frequency measurement range BPM accuracy Communication interface Electrical power supply Measurements Weight Type of electrical protection Level of electrical protection IP protection level Applicable standard Conditions of use Conservation conditions Transport conditions Operating conditions LED sensor wavelengths 1.9%
30-200 BPM 3%
Bluetooth SMART (4.0 or higher) 2 x 1.5V AAA alkaline batteries Main body 109x49x21 mm 60.7 g (including batteries) Internal power supply BF type part applied IP22 ATS/ERS Guidelines: 2005, 2019 update ISO 26782: 2009 ISO 23747: 2015 EN ISO 14971: 2019 ISO 10993-1: 2018 2011/65/UE Directive EN ISO 15223:2016 IEC 60601-1:2005 + A1: 2012 EN 60601-1-2: 2015 EN IEC 60601-1-6: 2010+Amd2013 EN 60601-1-11: 2015 ISO 80601-2-61: 2017 IEC 62304:2006/A1:2015 Device for continuous use Temperature: MIN -25C, MAX +70C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN -25C, MAX +70C Humidity: MIN 10% UR; MAX 93% UR Temperature: MIN +5 C, MAX +40 C Humidity: MIN 15% UR; MAX 93% UR Red light: 660 nm**
Infrared light: 880 nm**
Rev.1.8 User Manual Page 31 of 35 Smart One Oxi English Mean maximum optical power in output
** This information can be useful for the physician. 1.2 mW Warning: Life time - the expected life time (or service life) of the device if properly used and stored is 5 years. Rev.1.8 User Manual Page 32 of 35 Smart One Oxi English 14. INFORMATION ON BLUETOOTH WIRELESS TECHNOLOGY Bluetooth compliance:
Operating Frequency:
Max Output Power:
Operating Range:
Network Topology:
Operation:
Antenna type:
Modulation Technology:
Modulation Type:
Data Rate:
Data latency:
Data Integrity:
Bluetooth 5-Ready from 2.4 GHz to 2.4835 GHz TX: 0 dBm; 1 mW radius of 10 metres (range of vision) Star - bus Server Antenna integrated in the module FHSS GFSK 1 Mbit/second 7 40 ms Adaptive frequency hop, Lazy Acknowledgement, CRC at 24 bit, message integrity check at 32-bit Sending data packages every 60 ms. It includes 3 control bytes to enable the host to detect any missing packages and the device to re-transmit them. This device uses Bluetooth Smart technology for wireless communications, so as to provide reliable communication in electrically noisy environments and transmit data packages every 60 ms. It includes 3 control bytes to enable the host to detect any missing packages and the device to re-transmit them. In the event of the connection being interrupted, the app changes status, from connected to not-connected, and becomes immediately available for a connection. Profile based on GATT Format:
Quality of Service:
Bluetooth Profiles supported:
Authentication and Encryption:
Encryption Key Size:
Supported AES 128 bit with Counter Mode CBC-MAC and application level defined by the user The Bluetooth word mark and logo are registered trademarks owned by Bluetooth SIG, Inc. Rev.1.8 User Manual Page 33 of 35 Smart One Oxi English Communication at radiofrequency (RF) 14.1 This device conforms to the FCC standards (United States Federal Communications Commission) and to the international standards on electromagnetic compatibility. The following information is provided in accordance with the FCC (Federal Communications Commission) rules. The device complies to Part 15 of the FCC Standards. Operation is subject to the following conditions: (1) This device must not cause damaging interference and (2) this device must accept any interference received, including the interference which might cause an undesired functioning. The device does not interfere with the radiofrequency signals transmitted from external sources. The FCC standards were conceived to provide reasonable protection against excessive radiofrequency interference and to prevent malfunctioning of the device caused by undesired electromagnetic interference. 14.2 Interference in radiofrequency (RF) caused by other wireless devices The majority of consumer electronic devices on the same frequency band as used by SmartOne can prevent the uploader or the mobile device from receiving the data. This equipment has been tested and conforms to the limits for Class B digital devices in accordance with Part 15 of the FCC Standards. These limits are conceived to provide reasonable protection from damaging interferences in a residential context. 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. It is not however possible to guarantee that these interferences will not occur in a particular installation. The device causes damaging interference with the reception of radio or tv signals, which can arise by switching the equipment on or off; the user is advised to try to correct the interference by increasing the distance separating the equipment from the receiver. Rev.1.8 User Manual Page 34 of 35 Smart One Oxi English 15. WARRANTY TERMS SMART ONE OXI is guaranteed for a period of 12 months in the case of professional use
(physician, hospital, etc.) or 24 months for other use. The warranty period is effective from the date of purchase, which must be proven by an invoice or sales receipt. The device must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to the manufacturer. This warranty covers the repair or the replacement (at the discretion of the manufacturer) of the product or of the defective parts without charge for the parts or for the labour. All batteries and other consumable parts, including the turbine flow meter, are specifically excluded from the terms of this guarantee. The product warranty shall not apply, at the discretion of the manufacturer, in the following cases:
Improper handling, improper installation, improper operation of the device, or if the installation does not comply with local technical or safety regulations Use of the product for purposes other than those provided or failure to follow instructions Repair, adaptation, modification or tampering by third party Damage caused by lack of or incorrect maintenance Damage caused by abnormal physical or electrical stress, or by leaking batteries Serial number altered, deleted, 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 unauthorized opening of the device invalidates all guarantee claims. Customer shall be responsible for all transport, customs and delivery charges regarding the goods. Each product, or accessory, sent in for repair must be accompanied by a clear and detailed explanation of the fault. Forwarding to the manufacturer requires the written permission of the manufacturer himself. The manufacturer (MIR MEDICAL INTERNATIONAL RESEARCH S.r.l.) reserves the right to replace the product or make any changes deemed necessary. Rev.1.8 User Manual Page 35 of 35
1 | Label | ID Label/Location Info | 224.43 KiB | February 24 2022 |
(01)08052990321711
(21)A23-E001839 Model: SpiroBank OXI FCC ID: TUKMIRO65 . fe) A23-001839 Rx Sw) EC &
MIR via del Maggiolino 125 - 00155 Roma - ITALY p22 mm (0476
1 | Label II | ID Label/Location Info | 313.21 KiB | February 24 2022 |
Spirobank Oxi labeling rev.06 ST068 15/11/2021 Product name Product code Spirobank Oxi 911125xx DESCRIPTION MIR CODE LABEL Id label 451216 Rx Only label provided by MIR Amount needed one for each device Manufacturing period/IFU symbol Amount needed one for each device 451294 451293 451216 External label Amount needed one for each device 460026
(Example only for device MIR spirobank Oxi) 451234 Page 1 of 2 Spirobank Oxi labeling rev.06 ST068 15/11/2021 DESCRIPTION MIR CODE LABEL GUDID label for USA Amount needed one for each serial number 451216 451234 For Spirobank OXI The QR code in the GUDID label and in the external label must comply with the following requirements:
For Spirobank OXI EMS customization QR code type GTIN Global trade number Serial number GS1 Datamatrix 128
(01)08052990321711
(21)A23-Exxxxxx The bar code of the serial number in the external label must comply with the following requirement:
Bar code type 128 with readable part below UDI = UDI_DI + UDI_PI REF Description UDI-DI GTIN Lot Serial Number Exp date Manuf. Date
(01)
(10)
(21)
(17)
(11) 911125 Spirobank Oxi with reusable turbine 8052990321711 911125B0 Spirobank Oxi without reusable turbine 8052990321711 911125P1 Spirobank Oxi F/V with reusable turbine 8052990321711 911125P0 Spirobank Oxi F/V without reusable turbine 8052990321711 911125S1 Spirobank Oxi F/V SVC with reusable turbine 8052990321711 911125S0 Spirobank Oxi F/V SVC without reusable turbine 8052990321711 911125D0 Spirobank Oxi F/V SVC without reusable turbine
(EMS customization) 8052990321803 X X X X X X X Concerning the proper application of the labeling please refer to ILC038.
X X X X X X X
Page 2 of 2
1 | Label III | ID Label/Location Info | 133.64 KiB | February 24 2022 |
Smart One Oxi labeling Product name Product code Smart One Oxi 911120xx DESCRIPTION MIR LABEL CODE Id label 451217 Manufacturing period/IFU symbol Amount needed one for each device 451293 External label Amount needed one for each serial number the On the box must be attached two labels shown alongside. In addition attach the production year close to the white factory symbol 451217 GUDID label for USA Amount needed one for each serial number 451217 460021 The QR code in the GUDID label and in the external label must comply with the following requirements:
(Example) QR code type GTIN Global trade number Serial number GS1 Datamatrix 128
(01)08052990321803
(21)A23-Dxxxxxx The bar code of the serial number in the external label must comply with the following requirement:Bar code type 128 with readable part below Rev.5 Issue date: 16.07.2021 Page 1 of 1
1 | Agent Authorization Letter | Cover Letter(s) | 207.76 KiB | February 24 2022 |
MIR srl Medical International Research Via del Maggiolino 125, 00155 Rome Italy Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Nemko Canada Inc. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in FCC and Industry
with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with MIR srl Medical International Research, Via del Maggiolino 125, 00155 Rome Italy. Dated this 17th Day of November 20 21 Agency agreement expiration date:
17th November 2022 By:
Signature Giovanni Carlino Printed Title: CEO On behalf of :
MIR MEDICAL INTERNATIONAL RESEARCH Telephone: +39 062275777
1 | Confidentiality Letter | Cover Letter(s) | 167.74 KiB | February 24 2022 |
Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: TUKMIR065 Product Name: Spirobank Oxi Request for Confidentiality Pursuant to Sections 0.457(d) and 0.459 of the commissions rules, we hereby request that the following documents be held confidential:
Schematics
Block diagrams
Operation Description
Part list These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this By:
25th Day of January 20 22 Signature Giovanni Carlino Printed Title: CEO On behalf of :
MIR MEDICAL INTERNATIONAL RESEARCH Telephone: +39 06 22754777
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1 | 2022-02-24 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
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1 | Effective |
2022-02-24
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1 | Applicant's complete, legal business name |
MIR Medical International Research
|
||||
1 | FCC Registration Number (FRN) |
0015242621
|
||||
1 | Physical Address |
via del Maggiolino 125
|
||||
1 |
Rome, N/A 00155
|
|||||
1 |
Italy
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
V******@nemko.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
TUK
|
||||
1 | Equipment Product Code |
MIR065
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G**** C****
|
||||
1 | Title |
CEO
|
||||
1 | Telephone Number |
+3906********
|
||||
1 | Fax Number |
+3906********
|
||||
1 |
g******@spirometry.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Spirometer and oximeter | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Nemko S.p.A.
|
||||
1 | Name |
R**** G****
|
||||
1 | Telephone Number |
+39 0********
|
||||
1 | Fax Number |
+39 0********
|
||||
1 |
s******@nemko.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0006000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC