SmartOne User manual SmartOne User manual rev. 0.1 Issue date Approval date DRAFT VERSION Rev.0.1 Page 1 of 17 05.01.2015 05.01.
SmartOne User manual INDEX 1. INTRODUCTION ............................................................................................................................................................................................ 3 1.1 Intended Use ............................................................................................................................................................................................ 3 1.1.1 User Category ...............................................
SmartOne 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.
SmartOne User manual 1.1.2 Ability and experience required The correct use of the device, the interpretation of the results and the maintenance of the device, with particular attention to disinfection (cross-contamination risk), all require qualified personnel. WARNING The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow the instructions and warnings contained in this manual.
SmartOne User manual turbine flow sensor and oximetry sensor or other accessories may cause errors in measurement and/or compromise the correct functioning of the device, and is therefore not permitted. In the event of any incident or accident of any kind resulting from the use of the device, the user is required to inform the manufacturer without delay, according with Directive 93/42/EEC on Medical Devices. 1.2.
SmartOne User manual 1.2.3 Mouthpiece Any disposable mouthpieces included with the device are supplied only as a guide to the correct type and dimensions of the mouthpiece required for this device, they are clean but not sterile. To purchase appropriate mouthpieces, generally either paper or plastic but in any case mono-use/disposable, we suggest that you contact your local distributor who supplied the spirometer.
SmartOne User manual 1.4.1 Identification label The label shows: Serial number of the device Product name Name and address of the manufacturer Electrical safety symbol Warning symbol for the WEEE Directive Mark of conformity with the Medical Device Directive 1.4.2 Electrical safety symbol In accordance with IEC 60601-1 this product and its component parts are of type BF and therefore protected against the hazards of direct and indirect contact with electricity. 1.4.
SmartOne User manual The main features of this multipurpose Smart One® make it is easy to use and versatile. Spirometry function Smart One® 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).
SmartOne User manual Measured parameters: SYMBOL FVC FEV1 FEV1% FEV3 FEV3/FVC FEV6 FEV6% PEF FEF25 FEF50 FEF75 FEF2575 FET Vext FIVC FIV1 FIV1/FIVC PIF ELA *FVC *FEV1 *PEF VC IVC IC ERV FEV1/VC VT VE Rf ti te ti/t-tot VT/ti MVV(cal) DESCRIPTION Forced Vital Capacity Volume expired in the 1st second of the test FEV1/FVC x100 Volume expired in the initial 3 seconds of the test FEV3/FVC x 100 Volume expired in the initial 6 seconds of the test FEV1/FEV6 x 100 Peak Expiratory Flow Forced Expiratory Flow at 25
SmartOne User manual Compliance with standards Type of electrical protection Grade of electrical protection Grade of protection against water ingress Level of safety in the presence of inflammable anaesthetic gas, oxygen or nitrogen Conditions of use Essential performances (compliant with EN 60601-1: 2007) 2. 2.
SmartOne User manual normal mild moderate moderately severe severe very severe Through an analysis applied to some of the indices and parameters calculated in the FVC test, Smart One® produces a variety of quality control comments useful to understand the reliability of the test made.
SmartOne User manual 3. MAINTENANCE Smart One® is an instrument that requires very limited maintenance. The operations to perform periodically are: Cleaning and controlling of the reusable turbine The maintenance operations set forth in the User’s Manual must be carried out carefully. Failing to observe the instructions contained in the manual may cause errors in measurement or in the interpretation of measured values.
SmartOne User manual Rev.0.
SmartOne User manual MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino, 125 00155 - Roma - ITALY DECLARATION OF CONFORMITY CE (annex II excluding par.4) We hereby declare that the following device: Type Brandname Device name Class Spirometer MIR Medical International Research Smart One® IIa Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its amendments, and its transposition in the Member States. This statement is made on the basis of the CE Certificate n.
SmartOne User manual LIMITED WARRANTY CONDITIONS Smart One®, 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. The instrument must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing to the manufacturer.
SmartOne User manual ANNEX 1 INFORMATION FOR CORRECT USE IN ELECTROMAGNETIC ENVIRONMENTS Guidance and manufacturer’s declaration – electromagnetic emissions The Smart One® is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart One® should assure that it is used in such an environment.
SmartOne User manual IEC 61000-4-3 80 MHz to 2,5 GHz should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
SmartOne User manual FCC RF Exposure Information and Statement This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
