MIR Spirolab User Manual
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MIR Spirolab User Manual

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User manual Rev. 1.8
Rev.1.8
Spirolab
Date issued
Date approved
Spirolab
04.05.2020
.05.2020
04
Page 1 of 60

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  • Page 1 Spirolab Spirolab User manual Rev. 1.8 Date issued 04.05.2020 Date approved .05.2020 Rev.1.8 Page 1 of 60...

  • Page 2: Table Of Contents

    1.5.2 Oximeter specifications .......................... 20 1.5.3 Other features ............................22 USING THE SPIROLAB ........................... 24 Turning the spirolab on and off ......................24 Saving energy ............................26 Main screen .............................. 27 Symbols and icons ..........................27 Service menu ............................27 2.5.1...
  • Page 3 Spirolab MAINTENANCE ..............................52 Cleaning and checking reusable turbines ....................52 4.1.1 Checking correct turbine function ......................53 Cleaning the oximetry sensor ........................ 54 Recharging the battery pack ........................54 Replacing the thermal paper ........................55 TROUBLE SHOOTING AND SOLUTIONS ....................57 Guarantee conditions ..............................
  • Page 4 The nose clip, mouthpiece and turbine with mouthpiece that come supplied with the device are to be treated as single-use disposable items. The accessories supplied are ticked on the cover of the "New spirolab device equipment", supplied with the device.
  • Page 5 Thank you. MIR does not accept any responsibility for any harm or damage caused by users failing to follow the instructions or failing to heed the warnings in this manual. Total or partial copying of this manual is forbidden.

  • Page 6: 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 7: Individual Patient Factors That Can Affect Use Of The Product

    The product must not be used if malfunctions or faults are detected or suspected as these may compromise results. WARNING When the spirolab device is used as an oximeter, it has a limited alarm system and for this reason the SpO2 and pulse rate shown on the display need to be checked frequently.

  • Page 8: Important Safety Warnings

    Spirolab Important safety warnings Spirolab devices have been examined by an independent laboratory that has certified their conformity with EN 60601-1 safety standards and guaranteed that their electromagnetic compatibility is within the limits laid out in EN 60601-1-2. Spirolab devices are subject to continuous checks during production and therefore comply with the safety and quality standards laid down in Council Directive 93/42/EEC for Medical Devices.

  • Page 9: Turbine

    Spirolab 1.2.2 Turbine Disposable turbine WARNING If you decide to use the spirometer with a “disposable” turbine, it is important to use a new turbine for each patient. Adequate hygiene, safety and operational conditions of “disposable” turbines are only guaranteed if said turbines are preserved in the original, sealed packaging.

  • Page 10: Sensor For Oximetry

    Do not use sensors that appear to be or are damaged. If you do not have any more working sensors, contact your local distributor who supplied the device. Only use MIR sensors that have been specifically designed to work with spirolab. The use of other sensors may provide faulty readings.

  • Page 11: 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 12: Warnings For Use In Electromagnetic Environments

    The use of accessories and cables other than those specified by the manufacturer may result in increased emissions or decreased device immunity. The spirolab device should not be used close to or stacked with other equipment; if it must be used close to or stacked with other equipment, spirolab should be observed to verify normal operation in the configuration in which it will be used.

  • Page 13: Labels And Symbols

    Spirolab Labels and symbols 1.3.1 ID label The symbols are described in the table below: SYMBOL DESCRIPTION Product name Model Device serial number Manufacturer's name and address CE mark for medical devices: this product is a Class IIa medical device that is certified and in compliance with the requirements of...

  • Page 14: 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...

  • Page 15: Electrostatic Discharge Symbol

    Spirolab set to provide appropriate protection against interference when the device is used in the home. This device generates, uses and can emit radio signals and, if not installed or used as per instructions, can create interference with radio communications.

  • Page 16: Product Description

    Paying attention to areas that are not ESD-safe, e.g. using ESD-safe product packaging Product description Spirolab is a portable spirometer that can also features a pulse oximeter feature (optional). The device can operate completely autonomously or can be connected to a personal computer by means of USB or Bluetooth connections;...
  • Page 17 10,000 spirometric tests or about 500 hours of oximetry data. 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.

  • Page 18: Technical Specifications

    The device can be connected to a PC via a micro USB port. Spirolab performs FVC, VC & IVC and MVV tests and the ventilatory profile, as well as an acceptability (quality control) and reproducibility index of the spirometry test carried out by the patient.
  • Page 19 Spirolab Symbol Description U.m. FEV1/VC FEV1/ best between EVC and IVC x 100 Peak expiratory flow PEF Time Time to achieve 90% of the PEF FEF-2575 Median flow between 25% and 75% of FVC FEF7585 Median flow between 75% and 85% of FVC...

  • Page 20: Oximeter Specifications

    Spirolab Symbol Description U.m. Average exhalation time at rest TV/tI Mean inspiratory flow at rest L/min tI/tTOT tI/(tI+tE) Maximum voluntary ventilation L/min Estimated Lung Age years *= best values Flow/volume sensor Bi-directional turbine Temperature sensor semiconductor (0-45°C) Method of detection...
  • Page 21 Spirolab Rise in Pulse >= 10 BPM in a 8- 40 sec limited period and Pulse variation event subsequent drop >=8 BPM inside an overall period of 150 sec. Oximetry test parameters: Symbol Description u. m. %SPO2 min Minimum SPO2 during the test...

  • Page 22: Other Features

    Spirolab • Sounds during oximetry if battery low • Sounds in the event of no signal present (finger not inserted properly, connector not properly attached) • Sounds the next time the device is turned on following an interrupted test due to low...
  • Page 23 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. Rev.1.8...

  • Page 24: Using The Spirolab

    Spirolab USING THE SPIROLAB Turning the spirolab on and off To turn the spirolab on, press then release the button on the front of the unit. When you turn on the device, the first screenshot shows the internal software loading progress.
  • Page 25 Spirolab • Press OK on the following screen • The PIN must have 4 numbers. • Insert a PIN in the field “New PIN” using numeric keyboard, • Repeat the PIN in the field “Confirm new PIN”. • If the PIN is correct a popup will...

  • Page 26: Saving Energy

    Spirolab At the end the main screen will appear To turn spirolab off, press the power button on the front of the unit. 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.

  • Page 27: Main Screen

    Spirolab Main screen The device’s features can be accessed from the main screen. The following section details the features of each icon. Symbols and icons The following table shows the icons displayed on the various screens and what they mean...
  • Page 28 Spirolab To view headings, enter the PIN set or, if was not inserted a personal PIN, enter the default PIN which is the following: 1 2 2 3 If the personal PIN is missed touch the ? to unlock the device sending an enquire on the internet site described before (point 2.1).
  • Page 29 Spirolab To set the correct date and time, tap the box to bring up the cursor; use the numeric keypad on the lower right to set the correct value. The area “Daylight saving time” allows to set the automatic time change depending on the geographic area which you stay.
  • Page 30 Spirolab On the screen a numeric keyboard will appear with the fields to change the PIN. 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;...
  • Page 31 Spirolab This section allows to choose the unit of measure to show the PEF value: L/sec or L/min In the "Incentive" section, you can configure the paediatric incentive improve spirometric performance. The incentive may be enabled or disabled; should it be enabled, by selecting "ON"...

  • Page 32: Calibrating Turbines

    Spirolab Adults Children Knudson Zapletal MC-Barcelona Zapletal JRS-JAPAN JRS-JAPAN Chinese H.K. Chinese H.K. Pereira Pereira CECA1971 Knudson NHANES III NHANES III Padilla-Perez Knudson If you choose the last predicted value NHANES III, the limitations provided for in the past by the standard NHANES III will be applied.
  • Page 33 The FVC and FIVC values are not accepted. This means that the system is unable to correct such a large calibration error. In this case: - check that the spirolab is working properly by fitting a new turbine and/or - clean the turbine in question.

  • Page 34: Patient Data

    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 be: 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).

  • Page 35: Entering New Patient Data

    Spirolab 2.6.1 Entering new patient data This screen provides access to all patient data. The ID code is not required. Tap the grey space to access the various fields and make entries using the virtual numeric keyboard on the screen. Tapping the "Origin"...

  • Page 36: Editing Patient Data

    Spirolab ATS/ERS standards NHANES III standards Group % correction No group selected 100% Caucasian Caucasian 100% Afro-American Oriental 100% Mexican-American Hong Kong Chinese 100% Others Japanese Polynesian North Indian South Indian Pakistani Of African descent Aborigine In the case of ATS/ERS standards: depending on the ethnic group set, the correction...

  • Page 37: Viewing Stored Data

    Spirolab Viewing stored data 2.7.1 How to search the archives In the main screen, you can access the data present in the device archive by using the above icon. You can choose to search by: • • Surname • Date of birth •...
  • Page 38 Spirolab To view the spirometry tests performed by the selected patient, use the icon The information is displayed as in the image on the right. On the left you have the test trend in graph form (Flow/Volume Volume/Time), while on the right...

  • Page 39: Displaying The Last Test Session

    This function acts like an actual laboratory-based real time spirometer connected to a PC. Connection to the PC can be performed by USB or by a wireless Bluetooth connection. Spirolab becomes an intelligent sensor for measuring volume and flow rate while the PC controls the functions, including turning on and off.

  • Page 40: Performing A Spirometry Test

    PC are transferred to the device and remain active any other time you use the device remotely. 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.

  • Page 41: Fvc Test

    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 42: Vc Test

    Spirolab proportional to the speed at which air is being inhaled and exhaled. This helps the doctor understand when the rate of air flow is approaching zero and therefore when the patient has exhausted the volume available in exhalation and inhalation.

  • Page 43: Running Post Tests After The Administration Of A Drug

    Spirolab 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); you cannot perform POST tests on PRE VC or MVV tests;...

  • Page 44: Displaying And Reading Spirometry Results

    Thanks to a mathematical analysis known as quality control that is applied to some indices and parameters calculated in FVC tests, the spirolab device can produce different comments that help to understand the reliability of tests carried out.
  • Page 45 Flow > 100 mL in the last ½ second Flow > 40 mL in the last ½ second Between one test and the next, the spirolab device evaluates the repeatability of the following parameters: repeatable when the difference between the two furthest apart PEF values is ≤...

  • Page 46: Performing Oximetry

    1.2.4 can be used with the spirolab device. 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 47 If the sensor is not inserted correctly, icon transforms into and the icon appears alongside it. At the same time, the spirolab will beep (if set to do so in the service menu). Rev.1.8 Page 47 of 60...

  • Page 48: Instructions For Using The Sensor On Adult Patients

    At the same time, the spirolab will beep (if set to do so in the service menu). By tapping the icon, you can pause the alarm for a few minutes. If the alert situation persists, after a few minutes the beeping resumes.

  • Page 49: Data Transmission

    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. Rev.1.8 Page 49 of 60...

  • Page 50: Connecting With A Pc Via Usb Port

    "device" and the "master" device. At this point, spirolab can use the connection via SPP (Serial Port Profile) protocol. For details on using the protocol, please contact the manufacturer. Similarly, spirolab can be connected to a PC on which you have installed winspiroPRO.

  • Page 51: Printing Data

    For more support at this stage, refer WinspiroPRO software manual. Printing data Spirolab enables you to print both the last test performed and those stored in the archive. To print the last test performed, retrieve the test using the icon spirometry or for oximetry. When...

  • Page 52: Up-Dating Internal Software

    Spirolab Up-dating internal software When the device is connected to a PC via the USB port, the spirolab internal software can be up-dated Up-dates can be downloaded on registration from: www.spirometry.com. For further information about downloading up-dates, refer to the “winspiroPro” manual.

  • Page 53: Checking Correct Turbine Function

    4.1.1 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 54: Cleaning The Oximetry Sensor

    WARNING 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 55: Replacing The Thermal Paper

    Spirolab • When charged, disconnect the battery charger from the device and from the mains. WARNING Do not use the device when it is recharging Always disconnect the charger when recharging has been completed Replacing the thermal paper The following procedure describes the steps to perform in order to replace in the correct way the thermal paper roll.
  • Page 56 Spirolab If necessary make the paper advance by pressing the icon on the touch screen. When done, press OK icon. 4) Slide the paper through the slot on the lid of the thermal paper compartment. Close compartment WARNING Operator shall not touch simultaneously the patient and the parts of non-medical equipment that are accessible to the operator during routine maintenance after removal of covers without the use of a tool.

  • Page 57: Trouble Shooting And Solutions

    Spirolab TROUBLE SHOOTING AND SOLUTIONS PROBLEM MESSAGE POSSIBLE CAUSE SOLUTION Battery pack may be Charge the device using the flat charger unit The device may have Connect the device to a PC spirolab lost internal software via USB and up-date the doesn't turn software;...
  • Page 58 Spirolab PROBLEM MESSAGE POSSIBLE CAUSE SOLUTION Personalised Check the heading completion of parameter settings in parameter settings in the a spirometer the service menu “Spirometry”, "Parameters" test, some section of the service menu parameters as described in section 2.5 are not...

  • Page 59: Guarantee Conditions

    Spirolab GUARANTEE CONDITIONS The spirolab device and authorized accessories are guaranteed for a period of: • 12 months in the case of professional use (doctor, hospital, etc.) • 24 months where the product has been purchased by a patient for private use.
  • Page 60 MIR Medical International Research reserves the right to replace the product or make any changes to it that the company deems necessary. Rev.1.8...

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