MIR Spirobank II User Manual
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Summary of Contents for MIR Spirobank II
- Page 1 II User Manual User Manual Rev. 3.4 Issued on: 26.04.2011 Approved on: 26.04.2011 spirobank II User Manual cod. 980200 Rev 3.4 Page 1 of 57...
- Page 2 The winspiroPRO PC software supplied with the device MUST be installed correctly to the PC before connecting spirobank II to the PC. At the end of the installation, connect the device to the PC and the hardware will be "recognised" by the PC. The device can then be used with the winspiroPRO software.
- Page 3 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 II User Manual cod. 980200 Rev 3.4 Page 3 of 57...
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Page 4: Table Of Contents
1.5.1 Features of the spirometer ................16 1.5.2 Features of the oximeter ................17 1.5.3 Other features ....................21 FUNCTIONING OF THE spirobank II ............... 21 Keyboard......................21 Battery Level ..................... 24 Information ......................24 Initial Set-up ...................... 24 2.4.1 Turbine Calibration .................. - Page 5 ANNEX 1 OXYMETRY TEST REPORT EXAMPLES ........... 51 ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES ..........54 ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT ......................... 55 spirobank II User Manual cod. 980200 Rev 3.4 Page 5 of 57...
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Page 6: Intended Use
1.1.3 Operating environment spirobank II has been designed for use in a doctor‟s office, in a hospital or directly by the patient during day-to-day activities for the continuous monitoring of physical conditions. All information necessary for the proper use of the device in electromagnetic environments (as required by the EN 60601-1-2 Standard) is available from the manufacturer. -
Page 7: Who Can Or Must Make The Installation
The device should never be used when it is possible or probable that the validity of the results may be compromised due to any such external factors. WARNING The spirobank II when used as a pulse oximeter has limited alarms, therefore the device requires frequent display observation of SpO2 and pulse rate. spirobank II User Manual cod. -
Page 8: Important Safety Warnings
Important safety warnings spirobank II has been examined by an independent laboratory which has certified the conformity of the device to the European Safety Standards EN 601-1 and guarantees the EMC Requirements within the limits laid down in the European Standard EN 60601-1-2. -
Page 9: Mouthpiece
To avoid environmental contamination caused by the disposal of used mouthpieces, the user must follow all the relevant local regulations. 1.2.4 Oximetry sensor The oximetry sensors which can be used with spirobank II are the following: MANUFACTURER MANUFACTURER CODE DESCRIPTION... - Page 10 Use only MIR sensors supplied with, or specifically intended for use with the spirobank II. Use of sensors not intended for use with the spirobank II may cause inaccurate readings. Oximetry measurements may be inaccurate in the presence of high ambient light.
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Page 11: Device
MRI equipment may cause an induced current to the oximetry sensor, resulting in patient injury. If the PC and/or the printer connected to spirobank II come into contact with the area containing patient data, ref. directive EN 60601-1-1, it is necessary that they conform to the directive EN 60601-1. -
Page 12: Labels And Symbols
In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity. 1.4.4 Warning symbol for the RS232 serial port RS232 spirobank II User Manual cod. 980200 Rev 3.4 Page 12 of 57... -
Page 13: Warning Symbol For The Usb Serial Port
ORDER OF A PHYSICIAN FCC ID:TUK-MIR020 FCC ID:TUK-MIR020 spirobank II complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions: (1) this device must not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 14: Product Description
1.4.9 Product description spirobank II is a pocket spirometer, with an optional pulse oximetry module. It can operate in stand alone mode and it can be connected to a PC or to a printer using any one of several available methods: RS232, USB, Bluetooth. - Page 15 The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects. spirobank II is also able to transfer the stored test data through a simple acoustic coupling to a PC, so the patient can send test data by phone to the doctor. In this way the doctor can check the patient‟s condition remotely.
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Page 16: Technical Specifications
FIV1 Volume inspired in the 1 second of the test FIV1/FIVC FIV 1 % Peak inspiratory flow MVVcal Maximum voluntary ventilation calculated on FEV1 Slow vital capacity (expiratory) spirobank II User Manual cod. 980200 Rev 3.4 Page 16 of 57... -
Page 17: Features Of The Oximeter
Time passed with SpO2 < 90 % hh:mm:ss T < 89% Time passed with SpO2 < 89 % hh:mm:ss T < 88% Time passed with SpO2 < 88 % hh:mm:ss spirobank II User Manual cod. 980200 Rev 3.4 Page 17 of 57... - Page 18 Time passed with SpO2 < 89 % % hh:mm:ss T < 88% Time passed with SpO2 < 88 % % hh:mm:ss T < 87% Time passed with SpO2 < 87 % % hh:mm:ss spirobank II User Manual cod. 980200 Rev 3.4 Page 18 of 57...
- Page 19 Grade of dyspnea after walking Fatigue Borg Baseline Level of fatigue before walking Fatigue Borg End Level of fatigue after walking Walked Distance covered during walking Parameters measured with SpO2 Analysis: spirobank II User Manual cod. 980200 Rev 3.4 Page 19 of 57...
- Page 20 Continuous beep during oximetry measurement in the case of a low battery level. If the patient‟s finger is not inserted correctly or the connecter is not properly attached there will be an intermittent beeping sound for 10 seconds spirobank II User Manual cod. 980200 Rev 3.4 Page 20 of 57...
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Page 21: Other Features
Humidity: MIN 10% RH; MAX 95%RH Electrical Safety Standard IEC 60601-1 Applied norms Electro Magnetic Compatibility IEC 60601- FUNCTIONING OF THE SPIROBANK II Keyboard The spirobank II keyboard is composed of 7 keys: spirobank II User Manual cod. 980200 Rev 3.4 Page 21 of 57... - Page 22 The icons used in the various function screens and their meanings are shown in the following table: ICON DESCRIPTION To access the set up (Service Menu) of spirobank II To manage or enter new patient data from the main screen To enter new patient data To carry out a bronchodilator test...
- Page 23 IF no key is pressed the instrument after 1 minute will „beep‟ and if no key is pressed after 10 seconds it will automatically switch off. If spirobank II is powered by a USB connection to a PC, the aforementioned function is disabled and the device is...
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Page 24: Battery Level
2.3 Information Switch on spirobank II by pressing . The display will show: spirobank II – 0.1 (device name and software revision number) Power means (USB or battery symbol) Current date and time BTPS (Body Temperature Pressure Saturated) ... - Page 25 OK to enter and return to the Service Menu. Units Format Access with OK and select imperial or metric, as required. Press OK again to return to the spirobank II User Manual cod. 980200 Rev 3.4 Page 25 of 57...
- Page 26 Access with OK to search for available devices, select “Search Device” and then press OK; spirobank II will start to search for Bluetooth devices in the area; once one or more devices are found the screen will display profiles, press OK to set the device as printer or phone, select one of the two options and then press OK.
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Page 27: Turbine Calibration
2 - Insert both the FVC and FIVC values, obtained by the measurement made with the calibration syringe, in the New FVC and New FIVC field. Press to select the value to be modified (SIRIN, New FVC, New FIVC). spirobank II User Manual cod. 980200 Rev 3.4 Page 27 of 57... - Page 28 The correction of the inspired volumes and flows is made automatically as the machine has an internal temperature sensor; the BTPS values are thus calculated. If a 3L syringe is used to make the calibration and if the spirobank II is calibrated correctly then the FVC (syringe) value will be: 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
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Page 29: Patient Data
2.5 Patient Data Switch on spirobank II by pressing , or if already switched on, press icon); to access the “PATIENT DATA MANAGEMENT” screen, the following table describes the functions and displayed icons. ICON DESCRIPTION To enter new patient data To make a bronchodilator test (i.e. -
Page 30: Displaying Data In Memory
The data will be shown starting from the date entered up to the last file on memory. Full Memory: to show data in alphabetical order. The last data are marked by a double beep, then the data shown begin from the first one recordered. spirobank II User Manual cod. 980200 Rev 3.4 Page 30 of 57... -
Page 31: Online Operating Mode (Connected To A Pc)
Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils; Hold spirobank II at either end in two hands, or alternatively hold it in one hand as you would a cell phone. In either case, the display should be facing the user;... -
Page 32: Fvc Test
WARNING For accurate spirometry testing it is indispensable that all of the air contained in the lungs is expired. spirobank II User Manual cod. 980200 Rev 3.4 Page 32 of 57... -
Page 33: Vc Test
(FVC+FEV1) and will automatically show the results of this best test. To end the test press OK. During the test spirobank II emits "beeps", the frequency of which is directly proportional to the inspired and expired air velocity. This is useful to the doctor to understand when the velocity of the air is approaching zero, and therefore the patient has almost exhausted all of the inspired or expired volume. -
Page 34: Spirometry Test Interpretation
FVC test, spirobank II produces a variety of quality control comments useful for understanding the reliability of the test made. Where several comments related to the single test are calculated, spirobank II will only show the most important to facilitate the test interpretation. -
Page 35: Viewing The Spirometric Parameters
To exit the POST session select a new patient from the archive and press OK, the following message is then shown: Press OK to make new test on the selected subject Press OK again. spirobank II User Manual cod. 980200 Rev 3.4 Page 35 of 57... -
Page 36: Oximetry Testing
2.9 Oximetry testing spirobank II can carry out 4 different types of oximetry tests, which are described in the following paragraphs. WARNING If spirobank II as been purchased without the oximetry option, then only spirometry tests can be made. If the oximetry option is purchased afterwards, then contact the service centre or the manufacturer to enable the function. - Page 37 Alternatively, the display will show the screen with the oximetry tests that can be performed, specifically: ICON DESCRIPTION Walk test - 6MWT − Sleep oximetry Oximetry (SpO2/BPM) spirobank II User Manual cod. 980200 Rev 3.4 Page 37 of 57...
- Page 38 During the first few seconds of the test the device searches for the best signal, after which the timer re-sets to zero and spirobank II starts to memorise the data. If the sensor has not been correctly inserted, the following message will appear:...
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Page 39: Walk Test (6Mwt)
If the phase lasts for more than 6 minutes then spirobank II will emit a „beep‟ as a reminder to pass to the following walking phase. The number of bars (“... -
Page 40: Sleep Oximetry
). This test records the variations that the parameters of the patient undergo over night. After approximately 5 minutes, spirobank II will go on standby i.e., it stops beeping and the display turns off. The led signal remains on. To control the correct functioning while on standby, press , after 1 minute spirobank II will return to standby. -
Page 41: Spo2 Bpm Oximetry Test
The sensor described below is for illustration purposes only spirobank II is enabled for the use of any of the sensors described in the previous Paragraph 1.2.4. MIR does not recommend the use of a specific type of senor; any decision in made by each individual doctor. - Page 42 An over-tight sensor can produce inaccurate saturation measurements. Therefore avoid over tightening the adhesive tape. It is recommended to fasten the cable to the wrist with a bandage. spirobank II User Manual cod. 980200 Rev 3.4 Page 42 of 57...
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Page 43: Data Transmission
II includes a “Bluetooth” wireless data transmission system. This connection is through radio and allows spirobank II to be connected to a suitable cell phone. The method of data transmission allows the transferring of all the data in spirobank II. -
Page 44: Data Transmission Via Bluetooth For Printing
Bluetooth connection; alternatively a USB key can be installed on the printer in order to enable a Bluetooth connection. The Bluetooth system enables spirobank II to transfer test data directly to a Bluetooth enabled printer. The sequence of activities to be followed is: ... -
Page 45: Connection To A Pc Through The Rs 232
3.5 Upgrade Internal software spirobank II software can be upgraded when connected to a PC (USB or RS232). Upgrades can be downloaded by registering on www.spirometry.com. For further information on upgrading software see the “winspiroPro” software manual. -
Page 46: Cleaning And Controlling The Reusable Turbine
Switch on spirobank II as if to make a spirometry test (for example FVC) Hold spirobank II in one hand and move it gently from side to side so that air passes through the turbine If the rotor within the turbine is turning correctly then you will hear a beep that... -
Page 47: Cleaning The Oximetry Sensor
4.4 Changing the Batteries If the message "BATTERY DISCHARGED" appears on spirobank II display, or if the instrument does not switch on, the batteries inside the compartment shown here under must be changed as per the following points: ... -
Page 48: Problem Solving
Call a service centre or the manufacturer for replacement. PROBLEM SOLVING There follows a list of problems that may arise when working with spirobank II. Diagnostic messages are also shown on the display indicating the type of malfunction: 5.1 Causes and Solutions ... - Page 49 (annex II excluding par.4) We hereby declare that the following device: Type Spirometer Brandname MIR Medical International Research Device name spirobank II 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 50 LIMITED WARRANTY CONDITIONS spirobank II, together with its standard accessories is guaranteed for a period of: 12 months if intended for professional use (doctors, hospitals, etc.) 24 months if the product has been purchased directly by the end user.
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Page 51: Annex 1 Oxymetry Test Report Examples
ANNEX 1 OXYMETRY TEST REPORT EXAMPLES spirobank II User Manual cod. 980200 Rev 3.4 Page 51 of 57... - Page 52 II User Manual cod. 980200 Rev 3.4 Page 52 of 57...
- Page 53 II User Manual cod. 980200 Rev 3.4 Page 53 of 57...
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Page 54: Annex 2 Spirometry Test Report Examples
ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES spirobank II User Manual cod. 980200 Rev 3.4 Page 54 of 57... - Page 55 Guidance and manufacturer‟s declaration – electromagnetic emissions The spirobank II is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirobank II should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
- Page 56 Guidance and manufacturer‟s declaration – electromagnetic immunity The spirobank II is intended for use in the electromagnetic environment specified below. The customer or the user of the spirobank II should assure that it is used in such an environment. Immunity test...
- Page 57 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the spirobank II is used exceeds the applicable RF compliance level above, the spirobank II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
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Questions and answers
why would spirobank indicate change turbine when turbine only a couple of months old
The MIR Spirobank II may indicate a "change turbine" message even if the turbine is only a couple of months old due to improper operation, contamination, or malfunction. If the rotor does not spin properly or no beeps are heard during the turbine operation check, the turbine may need cleaning or replacement. Additionally, a new disposable turbine must be used for each patient to avoid cross-contamination. If reused or not functioning correctly, the device may prompt a turbine change.
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