Related Manuals for Cohero Health cSpirometer
Summary of Contents for Cohero Health cSpirometer
- Page 1 ™ Sensor Instructions for Use cSpirometer Sensor ™ Peak Flow and FEV1 Meter Instructions for Use © 2019 Cohero Health, Inc. ®...
- Page 2 FEV1 meter and its use consult your physician or other licensed healthcare professional. If you do not understand the instructions, contact Cohero Health, Inc. at the below address or through the “Help” module in the BreatheSmart app.
- Page 3 Measurements Date Recommendation Physician FEV1 Reserved for the physician or other licensed health care professional to write your good flow rates and to provide specific interventions he/she recommends for ranges of decreased flow rates. © 2019 Cohero Health, Inc. ®...
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Page 4: Table Of Contents
8.3. Cleaning of the Device...................... 8.4. Replacing Batteries......................9. Error Messages........................10. Troubleshooting......................... 11. Accuracy and Reliability....................12. Labels & Symbols....................... 13. Technical Specifications....................14. Bluetooth Wireless Technology Information............14.1. Radio Frequency (RF) Communication..............15. Warranty Items........................© 2019 Cohero Health, Inc. ®... - Page 5 2 AAA Batteries Health, Inc. at the below address or through the “Help” module in the BreatheSmart app. Instructions for Use Cohero Health, Inc. 12 E 49th Street New York, NY 10017 www.coherohealth.com support@coherohealth.com © 2019 Cohero Health, Inc. ®...
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Page 6: Indications For Use
1. Indications for Use cSpirometer sensor is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects. - Page 7 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 cSpirometer sensor 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.
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Page 8: Determining Your Pef Baseline Value
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. © 2019 Cohero Health, Inc. ®... - Page 9 © 2019 Cohero Health, Inc. ®...
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Page 10: Warnings And Precautions
PEF and FEV1 meter and its use consult your physician or other licensed healthcare professional. When cSpirometer sensor is used to monitor lung conditions such as asthma you should be under the care of a physician or other licensed healthcare professional. - Page 11 If you are unable to obtain a reading, contact your healthcare professional. Ask your physician or other licensed health care professional to watch you use your cSpirometer sensor before you rely on any measurements. Modifying your action plan or modifying your baseline value for your PEF measurement should only be done with direction from your physician or other licensed healthcare professional.
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Page 12: How To Start Using The Breathesmart App
5. How To Start Using the BreatheSmart ® Follow the instructions in the Maintenance section for correct battery insertion. Before connecting the cSpirometer sensor to a smartphone, install the BreatheSmart app. DOWNLOAD AND INSTALLATION BreatheSmart app may be downloaded from the App Store for iPhones or Play Store for Android. -
Page 13: How Cspirometer ™ Sensor Works
6. How cSpirometer Sensor Works ™ cSpirometer sensor is an electronic device for home use that accurately measures your PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). PEF is the maximum speed a person can blow air out of the lungs after... - Page 14 It is generally recommended to take measurements as directed by licensed healthcare professionals. cSpirometer sensor should also be used when you are feeling symptoms of breathing problems in order to help you and your physician or other licensed ©...
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Page 15: Peak Flow Results
Ask your physician or other licensed health care professional to watch you use the peak flow meter. This will help assure that you are using it correctly. cSpirometer sensor must be cleaned as shown in the Care and Cleaning section before your initial trial and periodically thereafter. - Page 16 Insert mouthpiece at least 0.5 cm Your cSpirometer sensor is now into the turbine socket. ready. Hold cSpirometer sensor with your hand as if it were a cell phone and make sure not to obstruct the turbine with your hand. © 2019 Cohero Health, Inc.
- Page 17 Since each test session should consist of three trials, repeat steps 4-7 twice more. cSpirometer sensor will save the highest value. Warning: Supervision of an adult is required for testing elderly subjects, children greater than five years of age and differently-able persons.
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Page 18: Interpreting Results
CAUTION: Ask your physician or other licensed healthcare professional to watch you use your cSpirometer sensor before you rely on any measurements. CAUTION: When cSpirometer sensor is used to monitor lung conditions such as asthma you should be under the care of a physician or other licensed healthcare professional. -
Page 19: Important Safety Warnings
Supervision of an adult is required for testing elderly subjects, children greater than five years of age and differently-abled persons. Cohero Health, Inc. cannot be held responsible for damage caused by the failure of the user to follow these instructions correctly. - Page 20 Do not modify the device without authorization from Cohero Health, Inc. All modifications, adjustments, repairs, reconfigurations must be performed by Cohero Health, Inc. or by authorized personnel. In case of problems, do not try to repair the device yourself. © 2019 Cohero Health, Inc.
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Page 21: Data Security Warnings
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 © 2019 Cohero Health, Inc. ®... -
Page 22: Warnings For Use In Electromagnetic Environments
BreatheSmart app is installed are no more than 2 meters apart. Do not use cSpirometer sensor near other devices (computers, cordless phones, cell phones, etc.) that generate strong electromagnetic fields. Keep such equipment at a minimum distance of 30 cm. If use under lower ©... -
Page 23: Notes On Fcc Certification
The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 7.3. Notes on FCC Certification cSpirometer sensor complies with Part 15 of the FCC Rules. Operation is subject to the following conditions: (1) this device may not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 24: Care And Cleaning
Consult the dealer or an experienced radio/television technician for help. 8. Care and Cleaning cSpirometer sensor is a device that requires little maintenance. The following operations are to be performed regularly: Cleaning and disinfection of the turbine Cleaning and disinfection of the mouthpiece... -
Page 25: Cleaning And Disinfection Of The Turbine
After each use, check the cleanliness of the turbine. To clean the turbine, pull it out of the cSpirometer sensor 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. -
Page 26: Cleaning And Disinfection Of The Mouthpiece
After cleaning, insert the turbine into the socket in the direction indicated by the closed padlock symbol on the cSpirometer sensor. 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. -
Page 27: Replacing Batteries
5 years or 1000 tests whichever comes first. Used cSpirometer 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. -
Page 28: Error Messages
Instructions for Use ™ Reattach the battery cover 9. Error Messages If you encounter any problems when using the cSpirometer sensor, a message will appear on the smartphone display to warn of the malfunction. Message Solution To perform measurements with the device, you must cSpirometer sensor needs you activate Bluetooth on the smartphone. -
Page 29: Troubleshooting
Avoid coughing Proceed to next measurement. 10. Troubleshooting If you receive an unusually low reading, it could mean that your cSpirometer sensor meter is broken, or it could mean that the reading is accurate and your asthma is getting worse. -
Page 30: Accuracy And Reliability
Peak Flow accuracy ±12% or ±25 L/min (±0.42 L/s ) whichever is greater 12. Labels & Symbols Symbols are described in the table below: Symbol Description Product Name Device serial number Manufacturer’s name and address © 2019 Cohero Health, Inc. ®... - Page 31 The symbol is used in accordance with IEC EN 60601–1–2: 2015 in section 5.1.1 for products including RF transmitters. FCC ID: Identification showing traceability to FCC compliance Instruction for use symbol. Read this manual carefully before using the medical device. Manufacturing date © 2019 Cohero Health, Inc. ®...
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Page 32: Technical Specifications
Peak Flow Accuracy Dynamic Resistance at <0.5 cm H2O/L/s 12 L/s Bluetooth SMART (4.0 or higher) Communication Interface 2 x 1.5V AAA alkaline batteries Power Supply Main body 109x49x21 mm Size 60.7 g (including batteries) Weight © 2019 Cohero Health, Inc. ®... - Page 33 Temperature: MIN –25°C, MAX +70°C Transport Conditions Humidity: MIN 10% RH; MAX 93%RH Temperature: MIN +5°C, MAX +40°C Operating Conditions Humidity: MIN 15% RH; MAX 93%RH *The accuracy limits include the tolerance of the ATS test procedure. © 2019 Cohero Health, Inc. ®...
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Page 34: Bluetooth Wireless Technology Information
CRC, 32-bit Message Integrity Check Data Sends data packets once per 60 ms. Includes 3 control bytes that allows the host to detect if packets are missing Format and the device to retransmit. © 2019 Cohero Health, Inc. ®... -
Page 35: Radio Frequency (Rf) Communication
Commission (FCC) and international standards for electromagnetic compatibility. The following information is provided in accordance with Federal Communications Commission (FCC) regulations. This device complies with Part 15 of the FCC Rules. Operation is subject to the © 2019 Cohero Health, Inc. ®... -
Page 36: Warranty Items
15. Warranty Items cSpirometer sensor is guaranteed for a period of 12 months. 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 Cohero Health, Inc. - Page 37 The repair or replacement described in this warranty is provided for goods returned at the customer’s expense to certified service centers authorized by Cohero Health, Inc. For details of these centers please contact either your local supplier or Cohero Health, Inc. Any unauthorized opening of the device invalidates all guarantee claims.
- Page 38 Instructions for Use www.coherohealth.com support@coherohealth.com @coherohealth facebook.com/coherohealth linkedin.com/company/coherohealth Copyright © 2021 Cohero Health, Inc. All rights reserved. Cohero Health, BreatheSmart, cSpirometer and Breathe Smarter are trademarks of Cohero Health an Aptar Pharma Company. LBL-IFU-000318 1/2021 0476 © 2019 Cohero Health, Inc. ®...
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