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Airofit Airocure, User Manual

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Airofit Airocure User Manual Download Page 22

 

 

 

 

 

21 

IEC 60601-1-2  

Medical electrical equipment  

Electromagnetic compatibility  
requirements and tests 

2014 

ISO 13485  

Medical devices  

Quality management systems - 
Requirements for regulatory 
purposes 

2016 

ROHS (2011/65/EU)  

Restriction of Hazardous Substances 
in electrical and electronic 
equipment  

2011  

REACH (EC 1907/2006)  

Registration, Evaluation, 
Authorisation and Restriction of 
Chemical  
substances  

2006 

WEEE  

Directive 2012/19/EU  

2012 

 
 

8.4 Radio Equipment Compliance  

The Airocure system complies with Radio Equipment Directive (RED) - 2014/53/EU. 

 

The device complies with part 15 of the FCC Rules. 

FCC ID: 2ATQX-AF003  

 

Summary of Contents for Airocure

Page 1: ...Airocure User Manual...

Page 2: ...pose and Scope 2 Intended Use and Users 3 Safety Precautions 4 Operation 5 Maintenance 6 Getting started with Airocure 7 Warning Notification 8 Troubleshooting 9 Technical Specifications 10 Airocure L...

Page 3: ...t cure or prevent any disease Intended users are End user of Airocure Personnel instructing the user of Airocure The Airocure Breathing Trainer is used in conjunction with the Airocure software applic...

Page 4: ...r more than 60 minutes per day Respiratory training can cause dizziness We recommend that you remain seated after training and breathe normally for a minimum of 1 2 minutes before moving on to other a...

Page 5: ...rocure mobile application and the selected sessions and programs Always set resistance to the recommended settings Do not drop your device Dropping it may result in malfunction or cause a decline in p...

Page 6: ...5 If you have more than one Airocure device do not swap the E Units...

Page 7: ...Airocure User Manual 4 1 Airocure System Description The Airocure system consists of the Airocure Breathing Trainer and the Airocure mobile application The Airocure Breathing Trainer provides resista...

Page 8: ...7 4 2 Getting to Know the Airocure Breathing Trainer...

Page 9: ...again Mouthpieces The mouthpieces are made of a softer material than the rest of the Airocure Breathing Trainer to ensure complete comfort during exercise To use the mouthpiece gently bend the sides o...

Page 10: ...with your hand on the E Unit Make sure the openings near the resistance wheels are not obstructed Place the device in your mouth so that your lips cover the outer shield of the mouthpiece and make a c...

Page 11: ...device if you are storing it for more than a week without use to avoid full battery depletion Remember to charge the Airocure Breathing Trainer fully before resuming usage Daily Maintenance As the dev...

Page 12: ...completely dry before reassembling Monthly Maintenance Charge your E Unit fully at least once a month even when not in use to avoid complete battery depletion 6 Getting Started with Airocure First ti...

Page 13: ...eight etc The percentages and arrows up or down relate to your progress between your current and previous test results 6 2 Start Training You will find your personalized training session within the ap...

Page 14: ...3 a problem if you find something wrong with the app The app also contains the Terms and Conditions requires internet connection and the Privacy Policy which you agreed to when you created your accoun...

Page 15: ...n exhale after filling your lungs completely Average range of the general adult population 3 0 6 0 liters Respiratory pressure Inspiratory strength Normal range 20 170 cmH2O Average 75 25 cmH2O Expira...

Page 16: ...15...

Page 17: ...Airocure Breathing Trainer Description Notes Air resistance Inhalation air resistance A F 20 200 cmH2O at 1 liter sec Exhalation air resistance 1 6 20 200 cmH2O at 1 liter sec NOTE Material Mouthpiece...

Page 18: ...e 3 7V Li ion 35mAh Capacity 10 hours Charger 5V min 100mA Charging time 8 hours Charger plug Magnetic connector Communication Bluetooth BLE version 4 1 Dimensions Size 70mm x 77mm x 33mm Weight 45g S...

Page 19: ...18 IOS version 11 or newer Android version 7 or newer...

Page 20: ...perature indoor 15 C to 35 C Temperature outdoor 0 C to 45 C Relative humidity 10 to 90 RH Pressure 960 hPa to 1 060 hPa IP classification IP65 Storage and transport conditions Temperature 25 C to 50...

Page 21: ...to the Medical Device Directive MDD 2007 47 EC The Airocure system is manufactured with compliance to medical device Class I The Airocure system complies with the EU Directive on personal data securi...

Page 22: ...HS 2011 65 EU Restriction of Hazardous Substances in electrical and electronic equipment 2011 REACH EC 1907 2006 Registration Evaluation Authorisation and Restriction of Chemical substances 2006 WEEE...

Page 23: ...ur 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...

Page 24: ...ent conomique Canada applicable aux appareils radio exempts de licence IC 25191 AF003 L exploitation est autoris e aux deux conditions suivantes 1 L appareil ne doit pas produire de brouillage 2 L app...

Page 25: ...rein will be replaced or repaired at no charge In case of a defective product return the product to the retailer from whom it was purchased provided that the store is a participating retailer Returns...

Page 26: ...oduced distributed or transmitted in any form or by any means including photocopying recording or other electronic or mechanical methods without the prior written permission of Airofit Medico A S Airo...

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