MIR Spirobank II User Manual
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MIR Spirobank II User Manual

MIR Spirobank II User Manual

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User Manual Rev. 1.6
Issued on:
22/02/2011
Approved on:
22/02/2011
spirobank
User Manual cod. 980007
spirobank
User Manual
Rev 1.6
Page 1 of 33

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محمود قشاش
April 10, 2025

أريد مخطط توصيل منفذ التنفس ضمن الجهاز

User image 67f7b3fc0e5ad
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1 comments:
Mr. Anderson
May 14, 2025

To connect the breathing port (turbine) on the MIR Spirobank II:

1. Remove the turbine from its packet.
2. Hold the turbine so the label faces the palm of the patient’s hand.
3. Insert the turbine into the device.
4. Push and twist it to lock it firmly in place.
5. Do not let the patient hold the back of the turbine, as this may restrict airflow.

This ensures proper airflow and accurate spirometry results.

This answer is automatically generated

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Summary of Contents for MIR Spirobank II

  • Page 1 spirobank User Manual User Manual Rev. 1.6 Issued on: 22/02/2011 Approved on: 22/02/2011 spirobank User Manual cod. 980007 Rev 1.6 Page 1 of 33...
  • Page 2 Thank you. MIR accepts no responsibility for any loss or damage caused by the User of the device due to instructions contained in this Manual and/or due to an incorrect use of the product.

  • Page 3: Federal Law Restricts This Device To Sale By Or On The Order Of Aphysician

    Copying this manual in whole or in part is strictly forbidden. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. spirobank User Manual cod. 980007 Rev 1.6 Page 3 of 33...
  • Page 4 INDEX INTRODUCTION ....................... 5 Intended Use ....................... 5 1.1.1 User Category ....................5 1.1.2 Ability and experience required ..............5 1.1.3 Operating environment ................... 5 1.1.4 Who can or must make the installation ............6 1.1.5 Subject effect on the use of the device ............6 1.1.6 Limitations of use - Contraindications .............
  • Page 5 INTRODUCTION Intended Use Indications for Use: The Spirobank spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates;...
  • Page 6 WARNING If the device is exposed to unsuitable environmental conditions, this could cause the device to malfunction and to give incorrect results. 1.1.4 Who can or must make the installation The device requires installation by qualified personnel. Normally the doctor configures the instrument before giving it to the patient for use at home.
  • Page 7 The manufacturer cannot be held responsible for damage caused by the failure of the user correctly to follow these instructions. The device must be used only and exclusively as a spirometer following the indications given by the manufacturer with particular attention to the paragraph on INTENDED USE, and utilizing only original spare parts and accessories.
  • Page 8 The turbine must never be held under a jet of water or air and must never come into contact with high temperature fluids. Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible damage.
  • Page 9 All applicable local regulations must be followed. If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages, however caused.
  • Page 10  Product name  Name and address of the manufacturer  CE mark in compliance with the Directive 93/42 EEC.  Electrical safety symbol  Warning symbol for the WEEE 1.4.2 CE mark for medical devices This product is certified to conform to the Class IIa requirements of the 93/42/EEC medical device directive.
  • Page 11 spirobank is specifically designed to measure a range of respiratory parameters. A quality control check is carried out internally on the measured parameters and the device has an internal memory to store data of the last session. spirobank is a powerful and compact measurement device, intended for use by a respiratory specialist or by a suitably trained generalist.
  • Page 12 spirobank gives an automatic interpretation of each spirometry test carried out, and assigns a “traffic light” feedback (green, yellow or red) for a rapid reading of the interpretation. spirobank is able to make FVC and VC tests and calculates an index of test acceptability (quality control) plus the reproducibility of the spirometry tests carried out.
  • Page 13 1.6.2 Other features Memory Memory capacity for the last session Display grafic LCD type SFTN,128x48 Pixel Keyboard Membrane keyboard with 5 keys Interface USB, Bluetooth Duration of the CR2032 3.6 V lithium Circa 10 years, under normal conditions of battery (memory backup) 1 battery 9V DC (type PP3), or through Power supply USB connection...
  • Page 14 OSD key On/Scroll down OSD key Switching on spirobank To switch on spirobank press and then release. Switching off spirobank To switch off spirobank press for at least two seconds. CONFIRM: to confirm and pass to the next phase, use Symbols and Icons The icons used in the various function screens and their meanings are shown in the following table:...

  • Page 15: Battery Discharged

    2.2 Battery Level The symbol shown in the second screen when the unit is turned on indicates that the battery is charged. The following symbol indicates Low Battery: If the battery is discharged the following message appears: BATTERY DISCHARGED 2.3 Information Switch on spirobank by pressing .
  • Page 16 Select the required option using and the ► symbol on the left of the screen; press to access options; select the required setup using the , then press to return to the Service Menu, press to return without modifications. Select Language Press to access the Menu, use to select the required language and press...
  • Page 17 Select Standard Access with and select the required standard using . Press to return to the Service Menu. WARNING With the standard NAHNES III is not possible to select or to modify the predicted values. Info Firmware Access through to view the version number of the following components, where available: ...
  • Page 18 300◄ correction FOR FACTORY CALIBRATION INSERT FVC = 0 The Old FVC and the Old FIVC values now shown are from the previous calibration. The values in % indicate the correction factor. These are pre-set to 0 by default. to set the desired values, use to go to the following value.
  • Page 19 For instance, if the calibration procedure is carried out with measured data: FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the resulting correction factor becomes: EXPIRATION .00% INSPIRATION .00% This does not represent an error, but is a logical consequence of the explanation detailed above.
  • Page 20 For ATS/ERS standards, the correction is applied to the predicted values of the following parameters: FVC, FEV1, FEV3, FEV6 For NAHNES III standards, the correction is based on several theoretical formulas (as described in the publication). press to complete the setting of the parameters, the main screen then appears. In the event of an error during the setting of patient data press to return to the previous screen.
  • Page 21  It is suggested to make testing in a standing position and during an expiration to lean forward, to help the expiratory action with a compression of the abdomen. WARNING Do not touch the keys during a test to avoid switching off the machine or stopping a test too soon.
  • Page 22 Six seconds from the start of the forced expiratory test, spirobank emits a continuous beep. This is useful to the doctor to understand if the patient has reached the minimum expiry time, as per the requirements of the major international pneumology associations. 2.8.2 VC Test Expiratory Slow Vital Capacity: VC...
  • Page 23 B= At least two acceptable manoeuvres, with the FEV1 values matching to within 101 to 150 mL C= At least two acceptable manoeuvres, with FEV1 values matching to within 151 to 200 D= only one acceptable manoeuvres, or more than one, but the FEV1 values not matching to within 200 mL (with no interpretation).

  • Page 24: Connection To A Pc Through Usb Port

    *= best values In case of “repeatability” a symbol ® is shown in the graphic area The following screens show other values compared to the predicted values. Parameters shown: FVC, FEV1, FEV1/FVC, PEF, FEF2575, ELA. *= best values II° case: NAHNES III standard Following an FVC test, the spirometry test results are shown.

  • Page 25: Maintenance

    To make the connection, insert the mini USB connector supplied with spirobank as shown in the picture and attach the other connector to the USB port of the PC. When making an initial connection, the PC will (depending on the version of the operating system) either make an automatic driver installation or request some information.
  • Page 26 MIR suggest the use of Perasafe, manufactured by Dupont, which has been tested with positive results on all MIR sensors. Rinse the turbine by immerging it in clean water (not hot).

  • Page 27: Problem Solving

     Close the battery compartment by replacing the back cover and sliding it towards the inside of the device. WARNING Use only 9 V type PP3 battery or equivalent. When inserting the battery in the battery slot, take care to connect the “+” and “-” as shown inside (see figure below). The device also has an internal lithium battery for the RAM memory and the average life is approximately 10 years.

  • Page 28: Declaration Of Conformity (Ce)

    (annex II excluding par.4) We hereby declare that the following device: Type Spirometer Brandname MIR Medical International Research Device name spirobank Class Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its amendments, and its transposition in the Member States.

  • Page 29: Limited Warranty Conditions

    MIR. MIR – Medical International Research reserves the right to modify the instrument if required, and a description of any modification made will be sent along with the returned goods.
  • Page 30 ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES spirobank User Manual cod. 980007 Rev 1.6 Page 30 of 33...
  • Page 31 ANNEX 2 INFORMATION CORRECT ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer‟s declaration – electromagnetic emissions The spirobank is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirobank should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 32 Guidance and manufacturer‟s declaration – electromagnetic immunity The spirobank is intended for use in the electromagnetic environment specified below. The customer or the user of the spirobank should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment –...
  • Page 33 Interference may occur in the vicinity of equipment marked with following symbol: NOTE UT is the a.c. mains voltage prior to application of the test level. 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.

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