Related Manuals for Cohero Health mSpirometer
Summary of Contents for Cohero Health mSpirometer
- Page 1 ™ Lung Function Sensor User Manual Before you use your mSpirometer sensor, please read this user manual, the labels and all the information with the product. 0476 LBL-IFU-000091 Rev.B Issue Date: 7.2018...
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Page 2: Table Of Contents
2. OPERATING THE mSPIROMETER SENSOR................. 2.1 Inserting the batteries......................... 2.2 Installing the BreatheSmart application..................® 2.3 Connection between mSpirometer sensor and smartphone............ 2.4 Performing the test..........................2.4.1 Evaluating the test........................2.4.2 Results diary........................... 2.5 Important safety warnings........................2.6 Data security warnings........................ - Page 3 Thank you for choosing a Cohero Health product. Before you use your mSpirometer sensor, please read this user manual, the labels and all the information provided with the product. Before connecting mSpirometer sensor to a smartphone, install the BreatheSmart application developed to show data measured by the device.
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Page 4: Introduction
1. INTRODUCTION 1.1 Intended use mSpirometer sensor is intended to be used either by a physician or by a patient under the instruction of a healthcare provider. The device is intended to test lung function and can perform spirometry testing in people of all ages, excluding infants and neonates. -
Page 5: Description Of Product
1.2 Description of product mSpirometer sensor is a pocket-sized system for measuring the following respiratory parameters: •PEF (Peak Expiratory Flow) •FEV (Forced Expiratory Volume in 1 sec) The following parameters are only available with a full spirometry test: •FEV... -
Page 6: Determining Your Baseline Values
(or another respiratory disease) there may be obstruction to expiratory airflow, so your numbers may be reduced. mSpirometer sensor thus helps you assess the health of your lungs, at any particular time. By using the device on a regular basis, you can track changes that may occur in the parameters. These changes, along with changes in how you feel, may require treatment, as prescribed by your healthcare provider. -
Page 7: Operating The Mspirometer Sensor
The BreatheSmart app can be downloaded at the App Store or Google Play. 2.3 Connection between mSpirometer sensor and smartphone Connection between the mSpirometer sensor and the smartphone is wireless. To check whether there is a connection, read the messages from the application. -
Page 8: Performing The Test
Push the turbine into the Turn the turbine clockwise slot until it stops until it stops Insert the mouthpiece at Pick up the mSpirometer sensor least 0.5 cm into the with your hand as if it were a cell phone. turbine socket. - Page 9 These movements push air into the turbine and affect the test results. Repeat the test three times. It is best to do the test mSpirometer sensor will save standing or sitting upright. the highest value. © Cohero Health, Inc 2018...
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Page 10: Evaluating The Test
Use and store the device in compliance with the environmental conditions specified in the Technical Specifications. If the device is subjected to environmental conditions other than those specified, it may malfunction and/or display incorrect results. © Cohero Health, Inc 2018... -
Page 11: Data Security Warnings
• Use a password to access the data • Verify the correct email address to which the test results should be sent • Call your healthcare provider to ask for confirmation of receipt when data is transmitted © Cohero Health, Inc 2018... -
Page 12: Warning For Use In Electromagnetic Environment
fields. Keep such equipment at a minimum distance of 7 meters. 2.8 Notes on FCC certification mSpirometer sensor complies with Part 15 of the FCC Rules. Operation is subject to the following conditions: (1) this device may not cause harmful interference... -
Page 13: Care And Cleaning
After each use, check the cleanliness of the turbine. To clean the turbine, pull it out of the mSpirometer sensor socket, turn it counterclockwise and simply pull it out. Pushing the base of the turbine gently with a finger may make removal easier. -
Page 14: Cleaning And Disinfecting Of The Mouthpiece
Once dry, insert the turbine into the socket in the direction indicated by the screen-printed closed padlock symbol on the mSpirometer sensor. To insert the turbine, push it down and turn clockwise until it stops. Make sure it is fully inserted into the plastic container. -
Page 15: Cleaning Of The Device
Reattach the battery cover Used mSpirometer sensor batteries should only be disposed of in special containers or preferably returned to the dealer of the device or to a special collection center. Local regulations apply. -
Page 16: Error Messages & Troubleshooting
4. ERROR MESSAGES & TROUBLESHOOTING 4.1 Error messages If you encounter any problems when using the mSpirometer sensor a message will appear on the smartphone display to warn of the malfunction. MESSAGE SOLUTION To perform measurements with the device, you must activate Bluetooth on the smartphone. -
Page 17: Troubleshooting
If problems occur when using the device, the following points should be checked. PROBLEM POSSIBLE CAUSE SOLUTION mSpirometer The Bluetooth connection Look for mSpirometer sensor on the list of recognized devices. sensor can’t is not working properly For correct use, the smartphone needs Bluetooth version 4.0 connect with the or higher. -
Page 18: Accuracy And Reliability
Time zero = tPEF - (VPEF/PEF) Image results for time zero spirometry Where PEF is the the peak expiratory flow; tPEF is the the elapsed time at PEF; VPEF is the the expired volume at PEF © Cohero Health, Inc 2018... -
Page 19: Labels & Symbols
This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC This indicates the manufacturer. MIR Medical International Research, Via del Maggiolino 125, Rome Italy. Instructions for use symbol. Read the manual carefully before using the medical device © Cohero Health, Inc 2018... -
Page 20: Technical Specifications
60.7 g (including batteries) Type of electrical protection Class II Electrical protection level IP protection level Regulations IP22 Applicable standards Electrical Safety IEC 60601-1 Electromagnetic Compatibility IEC 60601-1-2 ATS/ERS Standardization of spirometry 2005 ISO 26782 ISO 23747 © Cohero Health, Inc 2018... - Page 21 Temperature: MIN -40°C, MAX +70°C Storage conditions Humidity: MIN 10% RH; MAX 95%RH Transport conditions Temperature: MIN -40°C, MAX +70°C Operating conditions Humidity: MIN 10% RH; MAX 95%RH Temperature: MIN +5°C, MAX +40°C Humidity: MIN 10% RH; MAX 95%RH © Cohero Health, Inc 2018...
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Page 22: Bluetooth Wireless Technology Information
Bluetooth Profiles Supported: Authentication and Encryption: Supported Encryption Key Size: 128-bit AES with Counter Mode CBC-MAC and application layer user defined ® The Bluetooth word mark and logo are registered trademarks owned by Bluetooth SIG, Inc. © Cohero Health, Inc 2018... - Page 23 Common consumer electronic devices that transmit in the same frequency bands used by the mSpirometer sensor may prevent the uploader or mobile device from receiving data. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
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Page 24: Information For Correct Use In An Electromagnetic Environment
IEC 61000-3-3 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The mSpirometer sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the mSpirometer sensor should assure that it is used in such an environment. - Page 25 Power frequency magnetic fields should be at levels frequency characteristic of a typical location in a typical commercial or (50/60 Hz) hospital environment. magnetic field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. © Cohero Health, Inc 2018...
- Page 26 GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY The mSpirometer sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the mSpirometer sensor should assure that it is used in such an environment.
- Page 27 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the mSpirometer sensor is used exceeds the applicable RF compliance level above, the mSpirometer sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the mSpirometer sensor.
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Page 28: Warranty Terms
The device must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to Cohero Health. This warranty covers the repair or the replacement (at the discretion of Cohero Health) of the product or of the defective parts without charge for the parts or for the labor. - Page 29 Cohero Health, HeroTracker, mSpirometer, BreatheSmart, and Breathe Smarter are trademarks of Cohero Health, Inc.
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