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Micro Direct MicroLab Operating Manual

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MicroLab
Operating Manual
Federal (USA) law restricts this device to sale by or on
the order of a physician or licensed practitioner.
MAN1300
085-73
Issue 1.6
February 2019
Micro Direct, Inc.
803 Webster Street
Lewiston, ME 04240
1-800-588-3381
www.mdspiro.com
Mail In Yellow Warranty Card
Receive 25 PFT Filters
FREE!!

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  • Page 1 Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. MAN1300 085-73 Issue 1.6 February 2019 Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-800-588-3381 www.mdspiro.com Mail In Yellow Warranty Card...
  • Page 2 Indications for Spirometry Spirometry has been used extensively to measure lung function capability and to recognize and treat many diseases associated with the impairment of healthy lung functions. Spirometry today provides great insight into the status of any person’s health. Generally speaking, spirometry is a simple diagnostic tool used to define a subject’s lung condition.

  • Page 3: Table Of Contents

    Contents Introduction ................. 1 Contraindications ..............1 Warning and Cautions ............2 Indication for Use ..............2 Overview ................4 Getting Started ..............5 Calibration Check (Verification) ......... 14 Customization ..............17 Administration Mode ............18 Paper Loading ..............19 Switching Off ..............

  • Page 4: Introduction

    Introduction The MicroLab is a mains/battery operated portable spirometer with the unique combination of ease of use and sophistication. Ease of use is assured using context sensitive help screens, accessed at a touch of a button, that explain every MicroLab feature.

  • Page 5: Warning And Cautions

    Note: The device should be used by trained and qualified personnel. Indication for Use The MicroLab spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs.
  • Page 6 CAUTION: Read the manual before use. WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases, flammable anesthetic mixtures or in oxygen rich environments. CAUTION: Mouthpieces are single patient use. If used on more than one patient, there is a risk of cross-infection.

  • Page 7: Overview

    Overview The MicroLab uses a touch screen with icons representing each function available. A stylus, housed in the left- hand side of the unit, is provided for icon screen activation. Touch the displayed time to adjust time and date. Touch the toolbox icon to adjust volume and brightness.

  • Page 8: Getting Started

    Getting Started When performing a spirometry test, the recommended workflow is to enter the patient’s details, or retrieve them from memory, perform the required test and then print and save the results. Please ensure that the turbine transducer is plugged in to either of the two sockets on the right- hand side of the instrument.
  • Page 9 Select the ‘Patients’ icon to enter the patient database. The required patient may be selected from the stored patient list. If the patient details have not been previously stored, select ‘Add’ to enter the new patient’s details. The patient details also downloaded from...
  • Page 10 The following factors are recommended when using ECCS normal values: Hong Kong Chinese 100% Japanese American Polynesians North Indians and Pakistanis South Indians and those of African descent Ref: Lung Volumes and Forced Ventilatory Flows. P.H. Quanjet et al. Eur Respir J, 1993, 6, Suppl.
  • Page 11 If Relaxed Spirometry is selected, a volume/time graph will be displayed. Note the unit may be customized to perform a relaxed Vital Capacity with tidal breathing or from a single expiration or single inspiration. When a maneuver has been obtained select ‘Results’...
  • Page 12 From this menu, the results of the test may be viewed, saved, or printed and notes may be added. It is also possible to proceed to a forced baseline spirometry test, or a post medication relaxed spirometry test. Select ‘Exit’ when all the required functions have been used.
  • Page 13 Select the MVV icon to select this mode of testing and the display will instruct the patient to start breathing hard to commence the test. It is recommended that the patient perform 3 tidal breathing maneuvers prior to performing hard and fast rapid breathing (required for the MVV maneuver).
  • Page 14 The current maneuver will be displayed in black. During the maneuver, the breath rate (BR) will be displayed in green if the breath rate is acceptable (> 65 breaths per minute). If the breath rate falls below this level, it will be displayed in red to show the operator that the patient needs to be instructed to breathe harder...
  • Page 15 Once the test has finished, the display will show current test (shown in black – if more than one maneuver has been performed, the best maneuver will also be displayed in blue) the MVV rate, the % variation between maneuvers, the breath rate and the ATS quality warning for the test session.
  • Page 16 Select ‘Back’ to return to testing and the current maneuver. NOTE: If the breathing rate is insufficient (less than 65 breaths per minute) then the BR value will be displayed in red – an MVV value will be calculated and a message displayed that the MVV results was extrapolated from a maneuver with a poor breath rate.

  • Page 17: Calibration Check (Verification)

    Once testing is complete the MVV main menu will be displayed Select the appropriate icon to allow a Post 1 MVV test to be performed, View Results, Print Results, add notes for the patient’s examination, Save the tests or Exit to return to the main spirometer menu.
  • Page 18 Connect a 3-liter syringe to the transducer with the minimum of adapters and empty by pushing the handle fully in. Note: It is recommended that the transducer is disinfected prior to a calibration check (verification) or a SpiroSafe filter is used during the procedure.
  • Page 19 The calibration error for expiration and inspiration at each flow rate are displayed. The calibration error should be less than 3.5%. If a greater error is shown, repeat the procedure ensuring that the syringe is emptied and filled in a smooth manner without jerking the handle.

  • Page 20: Customization

    Customization The ‘Customize’ option from the main menu may be used to configure many of the features of your MicroLab and are divided into system, spirometry options and MVV options. System options allow you to configure the following: Language Height and weight units...

  • Page 21: Administration Mode

    Administration Mode Administration mode allows the administrator restrict availability of functions to the user by disabling icons on the main menu. For example, after the unit has been configured to administrator’s requirements, disabling of the ‘Customize’ icon will prevent any further adjustment by the user.

  • Page 22: Paper Loading

    It is recommended that only Micro Direct thermal printer paper (Cat No. 3327) be used with the MicroLab to avoid damage to the thermal printer head.

  • Page 23: Switching Off

    Charging Procedure The MicroLab’s internal batteries are discharged when shipped from the factory and should be fully charged on first use. If the MicroLab is not for a few months, it must be recharged every three months to keep the battery alive.

  • Page 24: Looking After Your Spirometer

    • Check the AC charger for compatibility with local power rating. Product Lifetime The MicroLab spirometer is designed for a product lifetime of 7 years. Cleaning Instructions Disinfection of contaminated parts is only effective after having them carefully pre-cleaned.

  • Page 25: Cleaning The Accessories

    Cleaning the Accessories With the use of a SpiroSafe filter (#3385) or a MicroCheck one-way valve safety mouthpieces (#3395) for each patient, cleaning of the transducer is recommended once a month. When using the disposable cardboard mouthpiece (adult: #3314SB or #3314B5, pediatric: #3301) without a filter and under the prerequisite that the patient was instructed only to exhale into the transducer, the following parts have to be cleaned once a day: transducer and pediatric adapter (if...

  • Page 26: Servicing

    Servicing There is no routine maintenance required for the MicroLab and there are no user serviceable parts in this instrument. Please return the unit to Micro Direct or an authorized agent if servicing is required.

  • Page 27: Troubleshooting Information

    Troubleshooting Information Should you encounter problems operating your MicroLab meter, please consult the table below: Problem Possible Cause Solution Display ‘freezes’ and the Multiple icons Hold the on/off button down unit does not respond to have selected or (approximately 10 seconds)
  • Page 28 appear, ensure required icon is selected Calibration procedure Turbine may be Repeat calibration failed or cannot be faulty procedure, if problem completed persists, replace turbine or return unit for servicing Turbine not fitted Ensure the syringe is fitted to tightly to the turbine using an adapter calibration if necessary...

  • Page 29: Safety Designation Per Iec 60601-1

    WARNING: The user must not touch any voltage carrying parts and the patient at the same time. During database upload, the MicroLab may be connected to a computer that complies with EN 60950 – ‘Information technology equipment – Safety – Part 1: General requirements’.

  • Page 30: Electromagnetic Compatibility (Emc) To Iec 60601-1-2

    (including other medical devices). The purpose of this testing is to ensure that the MicroLab is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the MicroLab.
  • Page 31 ESD event occurring, the device should be reset and located away from the source of interference. WARNING: The MicroLab should not be used adjacent to or stacked with other equipment. If adjacent or stacked use with other equipment is necessary, the MicroLab and the other equipment should be observed/monitored, to verify normal operation in the configuration in which it will be used.
  • Page 32 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The MicroLab is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroLab should assure that it is used in such an environment Emission Test Compliance...
  • Page 33 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The MicroLab is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroLab should assure that it is used in such an environment. Immunity IEC 60601 Test Level...

  • Page 34: Symbols

    Symbols Type B device In accordance with Directive 93/42/EEC Disposal compliance with your local waste management facility Consult the instructions for use Manufacturer Date of Manufacture Serial Number Federal U.S. law restricts this device to sale by or on the Rx only order of a physician.

  • Page 35: Specifications

    Specifications General Storage: >2000 tests including Flow/Volume loops and Volume/Time curves Display: Color 1/4VGA LCD. Power supply: Input 100 to 240V, 50 to 60Hz. Output 12V 2.5 A (Class 1) Type: ME30A1200F02 (PSU1012) Battery Pack: Rechargeable NiMH 8.4V 1A-hours Battery Life: Approximately 30 hours with a fully charged new battery 1.4"...
  • Page 36 Forced inspiratory flow at 25% of inhaled volume (FIF25) Forced inspiratory flow at 50% of inhaled volume (FIF50) Forced inspiratory flow at 75% of inhaled volume (FIF75) Forced expiratory flow at 50% of volume as a percentage of FIF50 (FEF50/FIF50) The time taken between 25% and 75% of the forced expired volume (MET2575) Forced Expiratory Time (FET) Tidal Volume (TV)

  • Page 37: Consumables / Supporting Products

    Battery TDX1048 Turbine Transducer ASS1206 Transducer Head Assembly 48-70 Protex Disinfectant Wipe To place an order for consumables / supporting products, for service/repair or for general questions please contact Micro Direct at: Toll Free: 1-800-588-3381 Telephone: 207-786-7808 Fax: 207-786-7280 Email: sales@mdspiro.com...

  • Page 38: Icd-10 Codes For Spirometry

    ICD-10 Codes for Spirometry Diagnosis Code Acute Bronchitis J20.0-J20.9 Allergic Rhinitis, Other J30.81-J30.89 Allergic Rhinitis, Unspecified J30.9 Vasomotor and Allergic Rhinitis J30.0-J30.5 Asthma, Mild, Intermittent J45.20-J45.22 Asthma, Mild, Persistent J45.30-J45.32 Asthma, Moderate, Persistent J45.40-J45.42 Asthma, Severe, Persistent J45.50-J45.52 Asthma, Unspecified J45.901-J45.909 Cough Variant Asthma J45.991...
  • Page 39 Pulmonary, Fibrosis J84.10 Respiratory conditions due to inhalation of chemicals, gases, J68.0-J68.9 fumes and vapors Respiratory conditions due to J70.9 unspecified external agent Sarcoidosis of the Lung D86.0 Sarcoidosis of the Lung with D86.2 sarcoidosis of the lymph nodes Bronchiolitis, Acute J21.0-J21.9 Bronchitis, Not Specified as Acute or Chronic...
  • Page 40 Occupational exposure to Z57.31 environmental tobacco smoke** Personal history of Z87.891 nicotine dependence** Smoking (tobacco) complicating pregnancy, O99.330-O99.335 childbirth, and the puerperium** Wheezing R06.2 **Use additional code after the primary diagnosis to identify any tobacco use, dependence or exposure to tobacco smoke Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of the manufacture.

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