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microQuark
PC-based Spirometer
Manuale Utente
User Manual
Manuel d'utilisation
Benutzerhandbuch
Manual del Usuario

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Summary of Contents for Cosmed microQuark

  • Page 1 PC-based Spirometer Manuale Utente User Manual Manuel d’utilisation Benutzerhandbuch Manual del Usuario...
  • Page 3 COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision, representation or use of this documentation. No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl.
  • Page 5: Table Of Contents

     Before starting ........................................20  Checking the packing contents ..................................20  Options/Accessories ....................................20  Preparing MicroQuark ......................................21  How to contact COSMED ....................................22 Complaints, feedback and suggestions ............................... 22 System maintenance ................................23  System maintenance ......................................24 ...
  • Page 6 Other known transmissible infectious diseases ............................25 Disposable in-line filters ....................................25  Other precautions and warnings .................................. 25  Introduction ........................................ 26  Cleaning ........................................26 Cleaning Agents/supplies .................................... 26 Standard cleaning procedure ..................................26  Disinfection ......................................... 27 Preparing the disinfecting solution ................................
  • Page 7: Getting Started

    Getting started...
  • Page 8: Important Notices

    Intended use  MicroQuark is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a physician responsibility. Caution: Federal law restricts this device to be sold by the order of a physician.
  • Page 9 13. Only the cable and accessories supplied with the equipment should be used with the device. The use of accessories and/or cables other than those supplied may result in increased emissions or decreased immunity of the equipment. 14. The device should not be used adjacent to or stacked with other equipment. If this is necessary, you must verify that the device continues to operate normally in the configuration in which it will be used.
  • Page 10: Contraindications

    Contraindications  Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions. Contraindications for the spirometry testing  Absolute contraindications For FVC, VC and MVV tests: Post-operative thoracic surgery patients. • For FVC tests: Severe instability of the airways (patients with severe Emphysema). •...
  • Page 11: Environmental Condition Of Use

    Equipment should not be installed near electrical or magnetic devices such as x-ray equipment, transformers or power lines. These devices could create electrical interferences when performing testing procedures. COSMED devices are not AP or APG units (according to EN 60601-1) and should never be operated in the presence of flammable anaesthetic mixtures.
  • Page 12: Emc

     Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 13 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test Test level Compliance level Electromagnetic environment –...
  • Page 14 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic environment – guidance Immunity test Test level Compliance level...
  • Page 15 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 16: Overview Of The Manual

    Overview of the manual  This manual is organized in the following chapters: Getting started. Describes the intended use of the device, how to properly use it and features of the unit and accessories. Installation. Lists the steps required to properly install the device. System maintenance.
  • Page 17: Introduction

    Introduction  MicroQuark is an instrument designed for lung function screening; the core of the system is the “intelligent” flowmeter that, connected to a Personal Computer (laptop or desktop), turns it in a complete spirometric lab. The system is composed by the turbine flowmeter, the measurement and data elaboration device (lightweight and ergonomic), the communication cable and by the Software pack.
  • Page 18: Microquark Overview

    For hygienic reasons, we strongly recommend the use of a bacterial filter, to be connected as in the picture by side. Note: While inserting the turbine, be sure to push the turbine up to touch the end of the reader. 16 - Getting started - MicroQuark overview...
  • Page 19: Paper Mouthpieces

    Note: The use of antibacterial filters is recommended even when using disposable mouthpieces to prevent cross- contamination. Nose clips  Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing manoeuvres. Getting started - MicroQuark overview - 17...
  • Page 21: Installation

    Installation...
  • Page 22: Before Starting

    Before starting  Before operating the MicroQuark you should inspect the equipment and complete the product registration. Checking the packing contents  When opening your product you should assure that the package contains the items listed in the packing list enclosed with the device. If there are any missing or damaged parts you should contact Cosmed’s technical assistance.
  • Page 23: Preparing Microquark

    Power supply is provided by PC through the USB plug. The unit is turned on/off automatically by the PC. Insert the turbine and be sure to push the turbine up to touch the end of the holder. MicroQuark connects to the PC as shown in the following picture. 1. microQuark 2.
  • Page 24: How To Contact Cosmed

    Rome - ITALY Voice: +39 (06) 931.5492 Fax: +39 (06) 931.4580 email: customersupport@cosmed.it Internet: http: //www.cosmed.com Complaints, feedback and suggestions If you have any complaints, feedback or suggestions you may inform us at complain@cosmed.it. 22 - Installation - How to contact COSMED...
  • Page 25: System Maintenance

    System maintenance...
  • Page 26: System Maintenance

    (to be required to the manufacturer). All materials used in the construction of the MicroQuark are non toxic and pose no safety risk to the patient or operator. Prior to the device cleaning, disinfection and inspection it is necessary to switch off the device and to disconnect adapters from the supply mains.
  • Page 27: Cleaning And Disinfecting

    Cleaning and disinfecting  The goal of infection control is to prevent the transmission of infection to patients/subjects and staff during pulmonary function testing. Cleaning and disinfecting instructions should be strictly followed to control infections and assure the safety of the patient. Aspiration of residue, particles and/or contaminated agents could be life threatening.
  • Page 28: Introduction

    Water Quality: tap water is acceptable for use in cleaning COSMED components. COSMED components should be soaked and rinsed in tap water at 22°-43°C to prevent the coagulation of solid substances onto the device and thus facilitate the removal of debris.
  • Page 29: Disinfection

    Step 2 Inspection. Inspect the items for damage at all stages of handling. If damage is detected on any of the components it should be identified and documented. Complete the disinfection/sterilization process and contact technical service for replacement. Step 3 Presoak. Protective attire is required of personnel handling contaminated items. At the processing area soak or rinse the items in tap water 22°-43°...
  • Page 30: Precautions To Take When Cleaning, Disinfecting And Drying The Turbine

    In order to let it dry, please shake it in air and/or connect it to the calibration syringe through the antibacterial filter and perform some strokes. After cleaning the turbine, check if the turbine propeller rotates freely even with a low speed air flow. Connect the turbine to the reader.
  • Page 31: Inspections

    Inspections  The equipment requires easy inspections to be carried out in order to assure a proper electrical and mechanical safety level in the years. These inspections are highly recommended after a rough use of the equipment or after a period of storage in unfavourable environmental conditions.
  • Page 33: Appendix

    Appendix...
  • Page 34: Dichiarazione Di Conformità

    • are classified in Class IIa; • their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and • ISO13485:2003 Norms, certified by CERMET (certificates nr. 387-A and 387-M); are CE marked according to the Medical Device Directive 93/42/EEC and certified by CERMET (certificate nr. MED 9811).
  • Page 35: Service - Warranty

     COSMED provides a one year limited warranty from the date of the original sale of the product. COSMED products are guaranteed to be free from defect upon shipment. Liability for products covered by this warranty is limited to the replacement, repair or issuance of a credit for the cost of a defective product at the discretion of COSMED.
  • Page 36 • Net weight • Reason for repair • If repairs are needed, you may contact COSMED at the one of the following addresses: COSMED S.r.l. Via dei Piani di Monte Savello 37 00041 Albano Laziale - Rome, Italy tel. +39 (06) 9315492 +39 (06) 9314580 E-mail: customersupport@cosmed.it...
  • Page 37: Privacy Information

    Dear Customer, We would like to inform you that your personal data is gathered and will be used by Cosmed Srl in conformity with the requirements of the Italian privacy law (Decreto Legislativo 196/2003). We believe it is important for you to acknowledge how your personal data is handled.
  • Page 38: Disposing Of Electrical Equipment

    Disposing of electrical equipment  The device cannot be disposed as unsorted municipal waste. Electronic equipment must be collected separately according to the European Directive 2002/96/EEC. Otherwise it can cause dangerous consequences for the environment and human health. The crossed-out wheeled bin means that the product must be taken to a separate collection when you wish to dispose of it. 36 - Appendix - Disposing of electrical equipment...
  • Page 39: Safety And Conformity

    Safety and conformity  Safety IEC 60601-1/EN 60601-1; The complete classification of the device is as follows: Class I type B • Protection against water penetration: IPX1 • Non sterile device • Device not suitable in the presence of flammable anaesthetics •...
  • Page 40: Technical Features

    Technical features  Flowmeter Bidirectional digital turbine Flow Range: 0 - 16 l/s Volume Range: 12 l Accuracy: ± 2% or 20 ml/s Resistance: < 0.6 cmH2O/l/s @14 l/s Mouthpieces: Ø 31 and Ø22 mm Dimensions: 150 x 45 x 53 mm Weight: 38 - Appendix - Technical features...
  • Page 41: Predicted Values

    Predicted values  ERS93 Standardized Lung Function Testing: Official Statement of the European Respiratory Society, The European Respiratory Journal Volume 6, Supplement 16, March 1993. Compilation of reference values for lung function measurements in children: Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s.
  • Page 42: Automatic Diagnosis (Algorithm)

    Compilation of reference values for lung function measurements in children: Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s. Reference Values for Residual Volume, Functional Residual Capacity and Total Lung Capacity - ATS workshop on Lung Volume measurements, official statement of the European Respiratory Society;...
  • Page 43 Blow out longer FET100% <6 sec. Blow out more air Flow >0.2l/s within 20 ml of FVC Blow out harder dPEF<10% Take a deeper breath dFVC<200ml and 5% best FVC Blow out faster dFEV1<200ml and 5% FEV1 That was a good test No errors FVC reproducible Diff.
  • Page 44: References

    References  Spirometry ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING, Edited by V. Brusasco, R. Crapo and G. Viegi: Standardisation of spirometry, Eur Respir J 2005; 26: 319–338 Lung function", J.E. Cotes, Blackwell scientific publications "Guidelines for Clinical Exercises Testing Laboratories", I.L. Pina, G.J. Balady, P. Hanson, A.J. Labovitz, D.W. Madonna, J. Myers. American Heart Association.
  • Page 46 COSMED srl Via dei Piani di Monte Savello 37, Albano Laziale - Rome 00041 ITALY O +39 06 931-5492 F +39 06 931-4580 info@cosmed.com cosmed.com...

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