MIR Spirolab Manual
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User manual Rev. 2.2
Rev.2.2
Spirolab
Date issued
Date approved
16.02.2023
16.02.2023
Spirolab
User manual
Page 1 of 39

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Summary of Contents for MIR Spirolab

  • Page 1 Spirolab User manual Spirolab User manual Rev. 2.2 Date issued 16.02.2023 Date approved 16.02.2023 Rev.2.2 Page 1 of 39...
  • Page 2: Table Of Contents

    1.5.2 Oximeter specifications ..................................13 1.5.3 Oximetry alarms description ................................14 1.5.4 Other features ......................................15 USING THE SPIROLAB.....................................16 Turning the spirolab on and off ................................16 Saving energy .......................................18 Main screen ........................................18 Symbols and icons .......................................18 Service menu ........................................19 2.5.1 Calibrating turbines ....................................22 Patient data ........................................24...
  • Page 3 Italian Portuguese Turkish French Brazilian Czechoslovak German Polish Vietnamese The following table describes the contents of the package and the accessories that can be used with spirolab: Description 672684 Carrying case ✓ 532367 USB cable ✓ 910350 Thermal printer paper ✓...
  • Page 4: Introduction

    If a spirolab user is a person who is incapable of looking after him or herself, the device must be used under the supervision and responsibility of the person who is legally in charge of that person.
  • Page 5: Important Safety Warnings

    WARNING When the spirolab device is used as an oximeter with limited alarm settings, the SpO2 and Pulse Rate shown on the display should be checked frequently.
  • Page 6: Risk Of Cross Contamination

    939008 These sensors require the use of the extension cable item code 919200 (length 1.5 m) for connection with the spirolab device. Prolonged use of a sensor or the patient's condition may mean that the location of the sensor has to be changed periodically. Change the position of sensors every 4 hours.
  • Page 7: Usb Connection Cable

    Do not use cables that appear to be or are damaged. If a new cable is required, contact your local distributor. Use only cables supplied by MIR, specifically designed to be used with Spirolab. The use of other types of cables can lead to inaccurate measurements.
  • Page 8: Warnings For Use In Electromagnetic Environments

    Keep these devices at a minimum distance of 30 centimeters. If it is necessary to use it at shorter distances, Spirolab and the other devices must be kept under observation to verify that they work normally.
  • Page 9: Fcc Certification Label

    1.3.2 FCC certification label Spirolab complies with section 15 of the FCC standards. Operation of the device is subject to the following conditions: (1) This device must not cause harmful interference (2) This device can be subjected to all types of interference, including those which may cause undesired effects Any modifications made without the express approval of this company may compromise the use of the device by the user.
  • Page 10: Product Description

    Spirolab is intended for use by medical specialists and it provides them with a powerful but compact tool that can process about 30 functional parameters. The device also provides a pharmacodynamic response, i.e. the % comparison of spirometric data measured before and after (PRE/POST) administration of a drug for bronchial provocation or bronchodilation.
  • Page 11 An individual patient’s clinical history values van vary significantly from normality values that always refer to a “healthy” subject. Spirolab can be connected to a PC or another computerised system. The spirometric data from every test is stored in the device and can be transferred to a PC and displayed (flow/volume curves, spirometric parameters, oximetric parameters optional).
  • Page 12: Technical Specifications

    Spirolab User manual Thermal Paper Display Mini USB Port Power Button MiniFlowmeter Disposable Turbine “FlowMIR” SpO2 port MiniFlowmeter port USB port (10) RJ45 port (11) DC IN 12V port Technical specifications Below is a complete description of the specifications for the device, the turbine volume and flow sensor and the oximetry sensor.
  • Page 13: Oximeter Specifications

    Spirolab User manual Symbol Description U.m. Inspiratory capacity: (maximum between EVC and IVC) -ERV Expiratory reserve volume Inspiratory reserve volume Tidal Volume Minute ventilation at rest L/min Respiratory frequency Breaths/min Average inspiratory time at rest Average exhalation time at rest...
  • Page 14: Oximetry Alarms Description

    Oximetry alarms description Spirolab is equipped with audio and visual alarm indicators to alert the operator to provide prompt patient attention or to abnormal device conditions. Spirolab detects both patient and equipment alarms. Both, patient alarms and equipment alarms are identified as medium priority as defined in IEC 60601-1-8 standard.
  • Page 15: Other Features

    Spirolab User manual When the alarm is activated through over limitation of physiological alarm, corresponding data area will view in reverse (video) mode. When the alarm is activated by more than one physiological alarm condition, each parameter will be displayed in reverse mode.
  • Page 16: Using The Spirolab

    MIR will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist service personnel to repair those part of the device that are designated by MIR as repairable by service personnel. USING THE SPIROLAB...
  • Page 17 Spirolab User manual Pressing OK then a message requires to confirm the use of a PIN: press OK to continue or Undo to skip this function. • Press OK on the following screen • The PIN must have 4 numbers.
  • Page 18: Saving Energy

    WARNING Spirolab does not turn off completely but enters an ultra-low standby mode; some features remain active to allow the device to keep the date and time updated and to be activated remotely if required. For this reason, the power key's symbol is corresponding to the standby mode.
  • Page 19: Service Menu

    Spirolab User manual ICON DESCRIPTION To save the settings and return to the main screen To exit without save and to return to the previous screen To view the last spirometry session for the current patient To view the last oximetry session for the current patient...
  • Page 20 Spirolab User manual Select the desired settings by tapping the white box; the selection is highlighted by an orange box. For the brightness of the display, move the orange cursor vertically until the desired brightness. To set the correct date and time, tap the box to bring up the cursor;...
  • Page 21 Spirolab User manual Spirometry The section is divided into: • Parameters • Outcome • Incentives In the “Parameters” section, you can select the values that will be displayed at the end of a test; these will be stated on the printout.
  • Page 22: Calibrating Turbines

    Spirolab User manual Oximetry Access to these settings is password protected and it is possible to configure both the physiological alarms - the lower and upper threshold values of the SpO2 and Pulse Rate parameters - and the technical alarms By setting the physiological alarms to "ON", the box is enabled to...
  • Page 23 BTPS factor to be calculated. If a 3-litre syringe is used for the test and if the spirolab device is perfectly calibrated, the FVC (syringe) value measured will 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
  • Page 24: Patient Data

    Spirolab User manual Patient data From the main screen, you can access the patient data management area: • create a new patient profile or check for existing patients in the archives • change current patient data 2.6.1 Entering new patient data This screen provides access to all patient data.
  • Page 25: Editing Patient Data

    Spirolab User manual In the case of GLI for every Ethnic group the device applies a different table to calculate the predicted values and not a correction percentage. Setting the Personal Best value for the patient the physician can define the predicted values for FVC, FEV1 and PEF parameters.
  • Page 26: Displaying The Last Test Session

    Spirolab User manual Select the patient required by tapping the line (which becomes orange) and choose one of the enabled functions listed at the bottom of the screen. The enabled icons are coloured, while the grey ones are disabled. To quit the archive, use the icon...
  • Page 27: Online Mode (Connected To A Pc)

    When the device is connected to a PC, it cannot be directly operated. The settings on the PC are transferred to the device and remain active any other time you use the device directly. For example, if you use spirolab connected to the PC and you set a particular turbine (disposable or reusable), this will remain the default turbine any other time you use the device remotely, until the device is restarted.
  • Page 28: Fvc Test

    Remember that for accurate spirometry results, it is essential that all the air is expelled from the lungs. The test can be repeated as often as required without the mouthpiece having to be removed from the mouth. In this case, the spirolab will automatically recognise the longer cycle (longer FVC+FEV1) and present the relative readings.
  • Page 29: Running Post Tests After The Administration Of A Drug

    Spirolab User manual WARNING It is important to remember to change the disposable mouthpiece and the disposable turbine at the end of a patient's test session. 2.9.4 Running POST tests after the administration of a drug WARNING To perform a POST test, the patient must have performed at least one PRE FVC test on the same day (i.e. in the same session);...
  • Page 30: Acceptability, Repeatability And Quality Messages

    The design of MIR spirometers with turbine is such that they are not subject to faulty zero-flow setting. For VC test the acceptability criteria according to ATS/ERS 2019 guideline is defined as follows: the VC test is considered acceptable is there is less than a 0.025 L volume increase over 1 second;...
  • Page 31: Interpreting Spirometry Results

    Spirolab User manual Warning message Warning trigger Instruction to patient Low final inspiration FIVC < 90% FVC after completely emptying your lungs, remember to breathe in - back to the top Incomplete inspiration FIVC < FVC fill your lungs completely before blasting out – take...
  • Page 32: Performing Oximetry

    MIR does not recommend any particular sensor; the decision is left to the doctor's discretion. During oximetry tests, the spirolab device cannot be turned off. To turn it off, you have to interrupt an on-going test. This system prevents unwanted interruptions that might compromise the reliability of data.
  • Page 33: Instructions For Using The Sensor On Adult Patients

    The first few seconds of a test are used for finding the strongest signal; once this has been found, the timer resets itself and the spirolab starts saving data.
  • Page 34: Data Transmission

    USB port technology. Data transmission via Bluetooth Spirolab can be connected as a "slave device" to any other "master device”. Therefore, you can connect spirolab to a PC or a mobile phone and control it using special applications.
  • Page 35: Printing Data

    Cleaning and checking reusable turbines The volume and flow turbine sensors usable with spirolab are of two types: disposable and reusable. These guarantee great accuracy and have the added benefit of not needing to be periodically calibrated. A simple clean before every use will ensure that the turbine keeps working as it should (only for reusable turbines).
  • Page 36: Checking Correct Turbine Function

    Checking correct turbine function • Turn the spirolab on and act as if you wanted to perform a spirometry test • Take the MiniFlowmeter in one hand and move it slowly from right to left and vice versa so that air passes through the turbine, •...
  • Page 37: Recharging The Battery Pack

    To charge the battery pack, only use the charger supplied by the manufacturer. When the spirolab device is turned on, an icon shows the condition of the battery in the top right hand corner: The maximum charge level is reached when the symbol is completely green.
  • Page 38: Trouble Shooting And Solutions

    WARNING Before contacting the service centre, if possible, download the device archive to the PC using the MIR Spiro program. This is necessary as the data may be lost during repair activities and also to protect the patient's privacy, as neither the manufacturer nor authorised personnel are allowed to see such data.
  • Page 39: Guarantee Conditions

    MIR Medical International Research reserves the right to replace the product or make any changes to it that the company deems necessary.

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