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PEF & FEV
meter
1
User Manual
Welcome to SpiroHome Lite
Before using your SpiroHome Lite (Ref No: 14000) device and mobile application,
please ensure that you have read this user manual, all labelling and information
provided with the product. The user manual can be downloaded and/or printed from
İnofab's website
and Apps.
(www.inofab.health)
14503.03
SUS-TD-074 R03
2/71
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Table of Contents
Related Manuals for SpiroHome Lite
Summary of Contents for SpiroHome Lite
- Page 1 User Manual Welcome to SpiroHome Lite Before using your SpiroHome Lite (Ref No: 14000) device and mobile application, please ensure that you have read this user manual, all labelling and information provided with the product. The user manual can be downloaded and/or printed from İnofab’s website...
- Page 2 Understanding the Test Quality Signs and Symbols Technical Features Safety Warnings and Precautions Maintenance Cleaning and Disinfection Cleaning and disinfection of SpiroHome Lite Cleaning and disinfection of SpiroWay Reusable Batteries Instructions for Handpiece Battery Replacement Disposal of SpiroHome Lite Troubleshooting...
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Page 3: Product Description
Store or Google Play Store. SpiroHom Lite consists of a handpiece, a removable Mouthpiece(SpiroWay Reusable), and a cap. The device is powered by 2 x AAA batteries for the. SpiroHome Lite works with the SpiroWay Reusable Mouthpiece. 1.2. What’s in the box? The SpiroHome Lite box contains: ●... -
Page 4: Intended Use
!!Caution: Please check to ensure that there is no visible damage on any of the components of the SpiroHome Lite. If the damage is present, do not use or attempt to repair the device, please contact the manufacturer directly. 1.3. Intended Use SpiroHome Lite is intended for home use to monitor PEF (Peak Expiratory Flow) and FEV (Forced Expiratory Volume in the first second). - Page 5 Furthermore, because PEF & FEV requires the active participation of the patient, inability to understand directions or unwillingness to follow the directions of the user manual and SpiroHome App will usually lead to submaximal test results. Relative Contraindications for PEF & FEV test;...
- Page 6 ➢ Physical conditions predisposing to the transmission of infections, such as hemoptysis, significant secretions, or oral lesions or oral bleeding !! Warning: If you have or suspect having any of the conditions consult your healthcare professional before using SpiroHome Lite. SUS-TD-074 R03 7/71...
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Page 7: Operation
1.5. Parameters The SpiroHome Lite records and displays the following PEF & FEV test data: Parameters Definition Unit Forced Expiratory Volume within 0.75 seconds: The volume of air that can forcibly be blown out within 0.75 seconds, after full 0.75 inspiration. - Page 8 The device should remain within this range for at least 1 hour before use. Storage / Transport Environment The required storage conditions for the SpiroHome ® Personal are: Ambient temperature: -20°C to +60°C...
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Page 9: Setting Up The Device
2.2. Setting up the Device 1. Download SpiroHome mobile application from Apple App Store or Google Play store into your smart device 2. Follow the steps given in the app to create an account as a new user or login to your existing account if you have one. - Page 10 SpiroHome App. pair the SpiroHome Lite with your smart device by following the instructions on the app. !!Caution: Pairing of the device is made inside the SpiroHome application. Do not try to pair ®...
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Page 11: Device Indicators
2.3. Device Indicators There are 3 LED lights located on the front of the device. The LED lights may be turned on or flashing various colors in various patterns. The LED lights indicate the current status of the device. Please see the following information for guidance on LED light indications. - Page 12 (as shown). You will hear a click when the mouthpiece is fully inserted into the device. 3. Open the SpiroHome App on your smart device and make sure you are signed in. Tap the ‘+’ button to start the test procedure.
- Page 13 5. Place the mouthpiece in your mouth past your teeth, and form a tight seal around the mouthpiece with your lips. 6. Without hesitation and with your lips sealed tightly around the mouthpiece, inhale rapidly to maximum lung capacity and then blow out the air in your lungs as hard and fast as you can.
- Page 14 8. After completing your test session, switch off the device by pressing the power key. Use the cap to protect the mouthpiece from contamination when the device is not in use. 2.5. Understanding the Test Quality After each test session, the quality of your test will be graded based on how well you performed the breathing maneuver and whether your results are acceptable, usable or neither.
- Page 15 Must have no glottic closure after 1 s of expiration Must achieve one of these three EOFE indicators: 1. Expiratory plateau (≤0.025 L in the last 1 s of expiration) 2. Expiratory time ≥15 s 3. FVC is within the repeatability tolerance of or is greater than the largest prior observed FVC †...
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Page 16: Signs And Symbols
*Or 10% of the highest value, whichever is greater; applies for age 6 years or younger only. NA: Not Applicable 2.6. Signs and Symbols Please note the following label, signs and symbols provided for the safe use and storage of the SpiroHome Lite. Markings Descriptions Markings Descriptions “Manufacturer”... -
Page 17: Technical Features
Humidity Limit Ref Number Atmospheric pressure limitation IP Number Do not use if the package is The device includes RF damaged transmitters The instruction Keep away from sunlight manual/booklet must be read. Keep dry Caution Corrugated fiberboard (cardboard) material 2.7. Technical Features Flow / Volume measurement method Ultrasonic transducer measurement Power Supply Handpiece... -
Page 18: Safety Warnings And Precautions
If any damage is present on the device or its components upon removal from packaging, do not use the device and return it to the supplier. e. Do not use SpiroHome Lite for any other purpose than its intended use. The SpiroHome Lite is not recommended for children under the age of 5. - Page 19 To prevent damage to the device due to battery leakage or oxidation, remove all batteries if the SpiroHome Lite is not to be used or is to be stored for a long period of time.
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Page 20: Maintenance
328. As this device operates with RF technology, it must be used as only specified by the manufacturer, it may avoid interference to radio communications. v. Handle SpirHome Lite and all its accessories with care and make sure not to drop or expose to any extreme stress. -
Page 21: Cleaning And Disinfection
3.1. Cleaning and Disinfection 3.1.1. Cleaning and disinfection of SpiroHome Lite You should clean the SpiroHome Lite body and cap at least once a week or whenever the device is visibly contaminated. You must perform the cleaning step before performing the disinfection step. Regular cleaning will prevent the physical buildup of contaminants on device surfaces. - Page 22 CAUTION: Prevent excess liquids contained within the wipes from entering the components of the SpiroHome Lite. Never immerse the product in water or any other liquid solution. 3. Perform Disinfection To disinfect the device and cap using a disinfectant* (Hydrogen peroxide >= 1 - < 2.5%, Glycolic acid >= 1 - <...
- Page 23 3.2. Batteries The SpiroHome Lite operates with 1.5V AAA batteries. The battery life of the SpiroHome Lite is approximately 12-18 months, assuming daily use of the device. The battery charge level is continuously monitored by the device. The device will not turn on if the battery charge level is low and will make a beeping sound to notify you.
- Page 24 3.2.1. Instructions for Battery Replacement 1. Remove cap and SpiroWay Reusable mouthpiece from the device. 2. Slide battery cover to open position. 3. Remove the empty batteries. SUS-TD-074 R03 25/71...
- Page 25 4. Insert new batteries in the correct orientation. Check the “+” and “-” signs on the battery and align the top sign on the battery with the battery cap. 5. Slide the battery cover back to the closed position. SUS-TD-074 R03 26/71...
- Page 26 4. Disposal of SpiroHome Lite This product is not to be discarded as regular household waste but should be discarded as electronic waste in accordance with local regulations and returned to a collection point of SUS-TD-074 R03...
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Page 27: Troubleshooting
PEF & FEV test video tutorial on app for proper test performed incorrectly performance Close the cap of the SpiroHome Lite to avoid The test does not Direct air current in the effects of environmental flow start - Cannot set... -
Page 28: Orderable Accessories
For any other technical queries please call our customer service on +90 312 988 03 08 or e-mail support@inofab.health 6. Orderable Accessories ● SpiroWay Reusable (Reference number: 03000) ● SpiroHome Lite Cap (Reference number: 14104) ● SpiroHome Pouch (Reference number: 01509) SUS-TD-074 R03 29/71... -
Page 29: Terms Of Warranty
İnofab at https://www.inofab.health/. 7. Terms of Warranty a. SpiroHome Lite, together with any accessories provided, is guaranteed for a period of 24 months, effective from the date of purchase, upon the provision of an invoice or sales receipt. - Page 30 Electromagnetic environment Emission Test Compliance guidance SpiroHome Lite uses RF energy for its internal function. Its Radio Bluetooth, BLE and WLAN module also complies with the national regulations. Therefore, its RF RF emissions CISPR 11 Group 1...
- Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity SpiroHome Lite battery-operated PEF & FEV meter devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such an environment.
- Page 32 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SpiroHome Lite devices are used exceeds the applicable RF compliance level above, the SpiroHome Lite device should be observed to verify normal operation.
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Page 33: Manufacturer Information
SpiroHome Lite devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of these SpiroHome Lite devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SpiroHome Lite device as recommended below, according to the maximum output power of the communications equipment. - Page 34 The SpiroHome Ultrasonic PEF & FEV meter and Accessories are CE certified (NB1984) products. SUS-TD-074 R03 35/71...
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