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MIR SMARTONE - Introduction and Device Overview; Intended Use and User Requirements

MIR SMARTONE
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SmartOne
Page 3 of 17
Rev.0.1
User manual
Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
WARNING
The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in the equipment should be considered
disposable products.
Before using your Smart One
®
Read this manual carefully, plus all labels and other product information supplied.
Smart One
®
should only be connected to a computer manufactured in compliance with EN 60950/1992.
WARNING
The winspiroPRO PC software supplied with the device MUST be installed correctly to the PC before connecting Smart
One
®
to the PC. At the end of the installation, connect the device to the PC and the hardware will be "recognised" by the
PC. The device can then be used with the winspiroPRO software.
Keep the original packaging!
In the event that your device requires attention then always use the original packaging to return it to the distributor or the
manufacturer.
In such an event then please follow these guidelines:
Return the complete device in the original packaging, and
The transport (plus any customs or taxes) costs must be prepaid.
Manufacturer’s address
MIR SRL: VIA DEL MAGGIOLINO, 125
00155 ROME (ITALY)
Tel ++ 39 0622754777
Fax ++ 39 0622754785
Web site: www.spirometry.com
Email: mir@spirometry.com
MIR has a policy of continuous product development and improvement, and the manufacturer therefore reserves the
right to modify and to update the information contained in this User’s Manual as required Any suggestions and or
comments regarding this product should be sent via email to: mir@spirometry.com. 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.
Copying this manual in whole or in part is strictly forbidden.
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
1. INTRODUCTION
1.1 Intended Use
Smart One
®
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 any setting.
1.1.1 User Category
Smart One
®
calculates a series of parameters relating to human respiratory function.
The product is therefore intended for use by a doctor or by a trained paramedic or technician under the supervision of a doctor.