MIR MiniSpir User Manual
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Summary of Contents for MIR MiniSpir
- Page 1 MiniSpir User manual MiniSpir User Manual Rev. 2.2.1 Issued on: 14.03.2023 Approved on: 14.03.2023 ENGLISH (EN) MINISPIR User manual Rev 2.2.1 page 1 of 17...
- Page 2 Thank you. MIR accepts no responsibility for any loss or damage caused by the User of the device due to the use of this Manual and/or due to an incorrect use of the product.
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Page 3: Table Of Contents
Technical features ............................... 10 1.6.1 Features of the spirometer ............................10 1.6.2 Other features ................................. 11 FUNCTIONING OF THE MiniSpir ............................12 Connection to PC ................................ 12 Using the MiniSpir ............................... 12 Spirometry Testing ..............................12 Acceptability, Repeatability and quality messages ...................... 13 Interpreting spirometry results ............................. -
Page 4: Introduction
User manual INTRODUCTION Intended Use MiniSpir spirometer is intended to be used either by a physician, respiratory therapist or technician. The device is intended to test lung function and can make: • spirometry testing in people of all ages, excluding infants and neonates It can be used in hospital setting, physician's office, factory, pharmacy. -
Page 5: Important Safety Warnings
Important safety warnings MiniSpir has been examined by an independent laboratory which has certified the conformity of the device to the Safety Standards IEC 60601-1 and guarantees the EMC Requirements within the limits laid down in the Standard IEC 60601-1-2. -
Page 6: Mouthpiece
BTPS values are thus calculated. If a 3L syringe is used to make the calibration and if the MiniSpir is calibrated correctly then the FVC (syringe) value will 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS). -
Page 7: Warnings For Use In Electromagnetic Environments
So the PC which the MiniSpir is connected must be compliant with IEC 60601-1. If the PC connected to MiniSpir is used in the area containing the patient, it is necessary that the PC complies with the EN 60601-1 Standard (ref. EN 60601-1 Standard). -
Page 8: Esd) Electrostatic Discharge Sensitivity Symbol
MiniSpir User manual Symbol Description Manufacturer symbol This product is certified to conform to the Class IIa requirements of the Regulation 2017/745/UE. 0476 In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity. -
Page 9: Product Description
Spirometry function MiniSpir calculates up to 30 functional respiratory parameters, as well as the parameter comparison after the administration of a drug (PRE/POST) for a bronchodilator test or for a bronchial challenge test. A comparison of data is made between POST (after- drug) and PRE (before drug administration). -
Page 10: Technical Features
The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects. MiniSpir is connected to a PC trough a USB port. Data measured by MiniSpir are transferred to the PC in real-time. The Windows “MIR Spiro”... -
Page 11: Other Features
MiniSpir User manual FIVC Inspiratory forced vital capacity FIV1 Volume inspired in the 1st second FIV1/FIVC FIV1/IVF x 100 Estimated lung age years Peak inspiratory flow FIF25 Maximum flow at 25% FIVC FIF50 Maximum flow at 50% FIVC FIF75 Maximum flow at 75% FIVC... -
Page 12: Functioning Of The Minispir
• Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils. • Hold MiniSpir in one hand as you would a cell phone. The side with the ID label should be in the hand of the user. -
Page 13: Acceptability, Repeatability And Quality Messages
After 6 seconds from the initial forced expiratory MiniSpir emits a continuous beep,. This is useful to the doctor to understand if the patient has reached the minimum expiry time pursuant to the requirements as set forth by the major international associations of pneumology. -
Page 14: Interpreting Spirometry Results
MiniSpir User manual Warning message Warning trigger Instruction to patient Abrupt stop suspected glottis closure if you feel your throat closing, relax, but keep pushing Cough in expiration suspected cough in first second of expiration try having a sip of water before the next blow Hesitation at hesitation time >... - Page 15 MiniSpir User manual The messages can include the following: Normal spirometry Light obstruction/restriction Moderate obstruction/restriction Moderately severe obstruction/restriction Severe obstruction/restriction Very severe obstruction/restriction The final interpretation level is "restriction + obstruction", where the indicator light indicates the worst parameter between restriction and obstruction.
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Page 16: Data Transmission
All data in the MiniSpir is transferred through a USB cable connection. Refer to Paragraph 2.1 of this Manual to connect the device to a PC. The data measured by MiniSpir during a spirometry test are sent to the PC in digital form and managed by the MIR Spiro software. -
Page 17: Problem Solving
LIMITED WARRANTY CONDITIONS MiniSpir, together with its standard accessories is guaranteed for a period of 12 months if intended for professional use (doctors, hospitals, etc.). The warranty is effective from the date of purchase contained in the relevant sales invoice or proof of purchase.
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