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Before you use your Spirobank Smart, please read this user manual,
the labels and all the information provided with the product.
User Manual Rev 2.8
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
Ver.2.8
Issue Date
User Manual
Spirobank Smart
ENGLISH
25 March 2021
0476
Page 1 of 27
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Summary of Contents for MIR Spirobank Smart
- Page 1 Spirobank Smart ENGLISH Before you use your Spirobank Smart, please read this user manual, the labels and all the information provided with the product. User Manual Rev 2.8 Issue Date 25 March 2021 0476 CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Ver.2.8...
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Page 2: Table Of Contents
Intended use ......................... 4 1.1.1 Restrictions on Use ....................4 Description of product ....................5 Information on the parameters measured by Spirobank Smart ........6 Determining your baseline values ................. 8 OPERATING THE Spirobank Smart ................... 8 Inserting the batteries ....................8 Installing the application for Spirobank Smart .............. - Page 3 ENGLISH Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product. Before you use your Spirobank Smart, please read this user manual, the labels and all the information provided with the product. Before connecting Spirobank Smart to a smartphone, install the application developed to show data measured by the device.
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Page 4: Introduction
1. INTRODUCTION Intended use Spirobank Smart spirometer is intended to be used by a physician or, by a licensed healthcare professional or by a patient under the instruction of a physician or of a licensed healthcare professional to test lung function. The device is designed for adult and pediatric patients, excluding infants and neonates. -
Page 5: Description Of Product
Spirobank Smart ENGLISH Description of product • Spirobank Smart 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 •... -
Page 6: Information On The Parameters Measured By Spirobank Smart
The device connects to a smartphone via Bluetooth SMART technology. Connection is automatic once the Spirobank Smart 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. - Page 7 Spirobank Smart thus helps you find out what sort of obstruction you have, if any, at a particular time. By using the device on a regular basis, you can track any changes that may occur in the parameters.
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Page 8: Determining Your Baseline Values
You may have a higher measures than the predicted value and you may not be healthy. Or you may have a lower measures than the average and be healthy. 2. OPERATING THE Spirobank Smart Inserting the batteries Follow the instructions in the Maintenance section for correct battery insertion. -
Page 9: Connection Between Spirobank Smart And Smartphone
Spirobank Smart ENGLISH Connection between Spirobank Smart and smartphone Connection between the Spirobank Smart and the smartphone is automatic. To check whether there is a connection, read the messages from the application. Performing the test In order to perform the test properly, please follow the instructions below. - Page 10 Spirobank Smart ENGLISH Insert the mouthpiece in your mouth 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 turbulence that might otherwise affect the results do not put your tongue in the mouthpiece.
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Page 11: Evaluating The Test
ATTENTION: ASK THE DOCTOR OR HEALTH CARE PROFESSIONAL TO SEE YOU USING THE Spirobank Smart BEFORE LAYING UP ANY MEASUREMENT. ATTENTION: IF YOU USE Spirobank Smart TO MONITOR A PULMONARY CONDITION FOR EXAMPLE IN THE CASE OF ASTHMA, THE PERSON MUST BE CAREED BY A DOCTOR OR ANOTHER HEALED HEALTH CARE PROFESSIONAL. -
Page 12: Results Diary
Spirobank Smart ENGLISH 2.5.1 Results diary The test results are automatically stored on the smartphone and can be displayed later. 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. -
Page 13: Data Security Warnings
Spirobank Smart ENGLISH Data security warnings Your smartphone stores your 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: •... -
Page 14: Notes On Fcc Certification
SPIROBANK SMART and the other devices must be kept under observation to verify that they work normally. Notes on FCC certification Spirobank Smart complies with Part 15 of the FCC Rules. Operation is subject to the following conditions: (1) this device may not cause harmful interference... -
Page 15: Care And Cleaning
• Consult the dealer or an experienced radio/television technician for help. 3. CARE AND CLEANING Spirobank Smart is a device that requires little maintenance. The following operations are to be performed regularly: • cleaning of the reusable turbine •... -
Page 16: Cleaning And Disinfection Of The Mouthpiece
After each use, check the cleanliness of the turbine. To clean the turbine, pull it out of the Spirobank Smart 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 17: Cleaning Of The Device
1000 tests, depending on which value is reached first. Remove the battery cover on the back of Remove the two batteries and replace the Spirobank Smart them with two new ones, following the polarity as indicated by the symbols in the compartment Reattach the battery cover Ver.2.8... -
Page 18: Error Messages & Troubleshooting
In any case, all applicable local regulations must be complied with. 4. ERROR MESSAGES & TROUBLESHOOTING Error messages If you encounter any problems when using the Spirobank Smart, a message will appear on the smartphone display to warn of the malfunction. MESSAGE... -
Page 19: Accuracy And Reliability
Spirobank Smart ENGLISH PROBLEM POSSIBLE CAUSE SOLUTION The Bluetooth connection is Look for Spirobank Smart on the list of Spirobank Smart can’t not working properly recognized devices. For correct use, the connect with smart phone needs Bluetooth version smartphone 4.0 or higher... -
Page 20: Labels & Symbols
Spirobank Smart ENGLISH 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 the 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. - Page 21 Spirobank Smart ENGLISH Symbol Description This product is a certified Class IIa medical device, and complies with the requirements of Directive 93/42/EEC 0476 In accordance with IEC 60601-1 the product and its applied parts are type BF and thus protected against the risks of electrical leakage.
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Page 22: Technical Specifications
Spirobank Smart ENGLISH 7. TECHNICAL SPECIFICATIONS Measured parameters: Peak Expiratory Flow PEF (L/min) Expiratory Volume in one second of testing FEV1 (L) Forced Vital Capacity FVC (L) Expiratory Volume in the initial 6 seconds of the test FEV6 (L) Average flow between 25% and 75% of the FVC... - Page 23 Spirobank Smart ENGLISH 2.5% or 0,05 L whichever is greater Volume accuracy (ATS 2019) 5% or 0,20 L/s whichever is greater Flow accuracy 10% or 20 L/min ( 0,33 L/s) whichever is greater PEF accuracy Dynamic resistance at 12 L/s <0,5 cm H2O/L/s...
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Page 24: Bluetooth Wireless Technology Information
Spirobank Smart ENGLISH Operating conditions Temperature: MIN +5 °C, MAX +40 °C Humidity: MIN 15% UR; MAX 93% UR Athmospheric pressure: 70kPa, 106 kPa Warning: Life time - the expected life time (or service life) of the device if properly used and stored is 5 years. -
Page 25: Radio Frequency (Rf) Communication
Spirobank Smart ENGLISH connected to disconnected and become available for a connection immediately. Bluetooth Profiles GATT-based profile Supported: Authentication Supported Encryption: 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. -
Page 26: Radio Frequency (Rf) Interference From Other Wireless Devices
9. WARRANTY TERMS Spirobank Smart, together with any accessories provided, is guaranteed for a period of: • 12 months in the case of professional use (doctor, hospital, etc.) • 24 months where the product is purchased directly by the end-user. - Page 27 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 make any changes deemed necessary. Ver.2.8...
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