spirobank G User Manual User Manual Rev. 2.0 Issued on: Approved on: spirobank G 15/06/2009 15/06/2009 User Manual cod. 980026 Rev 2.
Thank you for choosing a product from MIR MEDICAL INTERNATIONAL RESEARCH The original packaging contains the device with the followings accessories: Accessories market with spirobank G spirobank G bag spirobank G device spirobank G User Manual USB connection cable 1 x 9V battery mod.
Manufacturer’s address: MIR SRL VIA DEL MAGGIOLINO, 125 00155 ROMA (ITALY) Tel ++ 39 0622754777 Fax ++ 39 0622754785 Web site: www.spirometry.com Email: mir@spirometry.com MIR has a policy of continuous product development and improvement, and the manufacturer therefore reserves the right to modify and to update the information contained in this User’s Manual as required. Any suggestions and or comments regarding this product should be sent via email to: mir@spirometry.com. Thank you.
INDEX 1. INTRODUCTION ............................................................................................................6 1.1 Intended Use .........................................................................................................6 1.1.1 User Category ...................................................................................................6 1.1.2 Ability and experience required .........................................................................6 1.1.
4 MAINTENANCE ...............................................................................................................36 4.1 Cleaning and controlling the reusable turbine ......................................................36 4.2 Changing the Batteries ........................................................................................38 5 PROBLEM SOLVING ......................................................................................................38 5.1 Causes and Solutions ..........
1. INTRODUCTION 1.1 Intended Use Indications for Use: The Spirobank G 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; it can be used in any setting. 1.1.1 User Category The spirobank G spirometer calculates a series of parameters relating to human respiratory function.
The instrument is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents, nor in the presence of inflammable anaesthetic gases (oxygen or nitrogen). The instrument is not designed to be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or other sources of light or energy, dust, sand or any other chemical substances.
1.2 Important safety warnings spirobank G 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. spirobank G is continually controlled during its production and therefore the product conforms to the established security levels and quality standards laid down by the Council Directive 93/42/EEC for MEDICAL DEVICES.
Disposable turbine Reusable turbine If you are going to perform the spirometry test with a disposable turbine it is important to use a new turbine for each new patient. The characteristics, accuracy and the hygiene of the disposable turbine can only be guaranteed if it has been conserved beforehand in its original sealed packaging. The disposable turbine is made of plastic and its disposal after use should adhere to the local regulations and norms in force.
1.2.4 Device WARNING The maintenance operations detailed in this manual must be fully and accurately carried out. If these instructions are not followed this can cause measurement errors and/or an incorrect test interpretation. Any modifications, adjustments, repairs or reconfiguration must be made by the manufacturer or by personnel authorised by the manufacturer. Never attempt to make a repair oneself. The set-up of configurable parameters should only be made by qualified personnel.
If data have been successfully recovered, the device completes the standard switch on process, otherwise please contact an authorised technical assistance point or the manufacturer. In the case of a problem with the device, a message indicating the nature of the problem will appear on the screen, together with a warning “beep”. Operation of the device beyond its declared life (see § 1.6 Technical Specifications) could provoke a loss of data in the memory of the device (SRAM memory).
This product is certified to conform to the Class II requirements of the 93/42/EEC medical device directive. 1.4.3 Electrical safety symbol 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 USB port For connection to other devices such as PC.
• • • • Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. CAUTION Exposure to Radio Frequency Radiation This device must not be co-located or operating in conjunction with any other antenna or transmitter.
bronchial challenge test. A comparison of data is made between POST (after-drug) and PRE (before drug administration). The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principal. This principal ensures the accuracy and the reproducibility of the measurements, without requiring a periodic calibration.
carried out. The automatic test interpretation follows the latest 11 level ATS (American Thoracic Society) classification. Each test can be repeated as required. The best parameters are always available for review. The normal (predicted) values can be selected from several normal “sets”. For example, within the European Union the majority of doctors use the ERS (European Respiratory Society) predicted values.
ERV TV VE RR tI tE TV/tI tI/Ttot MVV ELA Expiratory reserve volume Tidal volume Ventilation per minute, at rest Respiratory frequency Average time of inspiration, at rest Average time of expiration, at rest Average flow of inspiration, at rest tE/(tI+tE) Maximum voluntary ventilation Estimated lung age L L L/min Breath/min s s L/min \ L/min year * = best values Flow/volume measurement system Temperature sensor Measurement principle Volume range Flow range Volume accuracy Flow accuracy Dynamic resistance
Humidity :MIN 10% RH; MAX 95%RH Temperature: MIN + 10 °C, MAX + 40 °C; Humidity: MIN 10% RH; MAX 95%RH Electrical Safety Standard IEC 60601-1 Electro Magnetic Compatibility IEC 60601-12 Operating conditions Applied norms 2. FUNCTIONING OF THE SPIROBANK G 2.
ICON DESCRIPTION To access the set up (Service Menu) of spirobank G To manage or enter new patient data from the main screen To enter new patient data To carry out a bronchodilator test To make the test following the administration of a bronchodilator To modify data of the current subject To carry out a spirometry test To access to the previous tests To access to transmission data area To search for tests made Visualize tests for current subject To view best test of the current subject To view the second b
To carry out a VC test To carry out an MVV test To display previous tests in memory To display next test in memory Visualize data for a test in archive To print data in memory (through Bluetooth connection) To transfer data through a Bluetooth connection To exit from the selected screen and return to the main screen WARNING IF no key is pressed the instrument after 1 minute will ‘beep’ and if no key is pressed after a further 10 seconds it will automatically switch off.
• • • • Version 1.0 (version of firmware ie internal software) Power source (USB or battery symbol) BTPS (Body Temperature Pressure Saturated) Current date and time • icon (Access to the Service Menu) • icon (Return to the main screen) Press to go to the second screen. The second screen will show: • ATS/ERS Standard • Subjects in memory (no. of registered patients) • Spiro (no. of spirometry tests made) • Available memory (% value of free memory) If there is no information or test data in memory, i.
• Bluetooth Settings • Info Firmware or and the ► symbol on the left of the screen; press Select the required option using to access options; select the required setup using the or , then press to return to the Service Menu, press to return without modifications. Select Language to access the Menu, use or to select the required language and press Press to save the change and return to the Service Menu.
Access with and select imperial or metric as required with return to the Service Menu. or . Press Turbine Setup and select the turbine in use (disposable or reusable) with Access with again to return to the Service Menu. Select Standard and select the required standard using Access with Service Menu. or . Press again to or . Press to return to the WARNING With the standard NAHNES III is not possible to select or to modify the predicted values.
Having set the parameters as required from the Service Menu press screen, and then the following is shown: to access the second Which indicates: • Patient ID code* and ethnic group • Birth date (dd/mm/yyyy) • Height (cm) • Weight (kg) • Sex (S) • Function icons** * the ID code is created automatically when new patient data is entered and is progressive. ** the icon “VC-MVV” is not shown when the standard NAHNES III is selected. The symbol is shown only in the POST phase. 2.4.
To clarify: using a 3 litres syringe, the expected FVC value is 3.08 L, the expected FIVC instead is in function of the ambient temperature. Press to turn to the service menu without applying any calibration factor. If % FVC and FIVC are more than 10%, the device cannot correct such a value; in this case: - Check the correct functioning of the spirobank G with a new turbine and/or - Clean the turbine.
2.5 Subject Data , or if already switched on, press ( icon); to Switch on spirobank G by pressing access the “PATIENT DATA MANAGEMENT” screen, the following table describes the functions and icons. Icon Key Description To enter new patient data Go to the main screen To modify data of current subject To make a bronchodilator test (i.e. make a test after drug administration with defined dosage; to carry out this test, a base PRE test is required, i.e.
For ATS/ERS standards, the correction is applied to the predicted values of the following parameters: FVC, FEV1, FEV3, FEV6, VC 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. To interrupt data input press , which then goes back to the main screen.
KEY ICON FUNCTION Search by ID Code Return to the main screen Display files from a date onwards (partial memory) Display files from beginning to end (complete memory) Search by ID Code: enter the ID Code of the patient required then to access the data. Search for date: enter test date of the required file; then press to access test data. The data will be shown starting from the date entered up to the most recent file in memory. Full Memory: to show test data in alphabetical order.
At this stage it is possible to: • Print selected test data via the Bluetooth connection by pressing • Scroll through the list of data in memory pressing • Show all results of the selected test, pressing or to return to the main screen; • Make a new test on the selected subject pressing with the following message: ( ( icon); icon) ( icon) and then using ( and icon); a new screen is shown Press OK to make NEW Test on the selected subject Press to confirm, otherwise to return to the list of data i
• Insert the mouthpiece into the protruding part of the turbine, by at least 0.5 cm; • Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils; • Hold spirobank G at either end in two hands.
A test is always memorised together with the details of the current patient. To make a test on a patient previously inserted then you must firstly recall the patient from the memory, see the final part of paragraph 2.6 for details. 2.8.1 FVC Test The phases as described on the screen must be followed, specifically: EXPIRE quickly INSPIRE slowly It is possible (and may be helpful) to start the test by breathing for a few moments at rest.
2.8.2 VC Test Ventilatory Profile The Slow Vital Capacity test can be started by carrying out several complete breaths at rest. After three or four such breaths a beep will sound to confirm that the ventilatory profile has been measured and now you can proceed to carry out the VC or IVC test. as shown in the screen. At end of the test press Expiratory Slow Vital Capacity: VC After the beep inspire slowly as much air as possible and then expire slowly as much air as possible.
Through an analysis applied to some of the indices and parameters calculated in the FVC test, spirobank G produces a variety of quality control comments useful to understand the reliability of the test made. This control quality check assigns a letter for the current session as described below: PRE Test A = At least two acceptable manoeuvres, with the highest two FEV1 values matching to within 100 mL and the largest two FEV6 values within 100 mL.
FLOW ERROR If the last flow point of the F/V curve is greater than 200 mL/s, this indicates that the expiration was not complete and thus the following comment is shown: BLOW OUT ALL AIR IN LUNGS Between two tests, spirobank G evaluates the repeatability of the following parameters: PEF VC repeatable when the difference between the two largest PEF is ≤ 0.67 L/s; repeatable when the difference between the two largest VC is ≤ 150 mL; If FVC is > 1.
values (or to the PRE values in the case of a POST phase), the Flow/Volume curve plus a traffic light summary of the test interpretation (in the upper right ), as illustrated below. *= 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 (or to the PRE values if is a POST phase). Parameters shown: FEV6, FEV1, FEV1/FEV6%, FEF2575, FVC, FEV1/FVC *= best values 2.8.
3 DATA TRANSMISSION WARNING Read the instructions carefully before starting data transmission, taking care to ensure that all the information has been properly understood. 3.1 Data Transmission via Bluetooth for printing WARNING Printing is possible only if the printer has a Bluetooth connection; alternatively an USB adaptor can be installed on the printer in order to enable a Bluetooth connection. The printer used must be in the list of printers accepted by the device.
If winspiroPRO is already installed on the PC then a new installation is not required. When using a Bluetooth connection, the instrument can be used for on-line spirometry testing & internal memory downloading Correct use of the Bluetooth connection implies the use of a Bluetooth key connected to the PC. To make the connection, insert the mini USB connector supplied with spirobank G as shown in the picture and attach the other connector to the USB port of the PC.
The turbine utilized by spirobank G belongs to one of two categories: disposable or reusable. These both guarantee precise measurements and have the great advantage of requiring no periodic calibration. In order to maintain the characteristics of the turbine a simple cleaning is required prior to each use (only for the reusable turbine). Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after use.
Once the turbine has been cleaned insert the turbine in its place and follow the instructions indicated by the closed lock symbol printed on the plastic casing of the spirobank G. To insert the turbine correctly push it and then turn it clockwise until reaching the stop, which ensures that the turbine has been blocked inside the casing. To ensure the turbine is functioning correctly repeat the controls described above; if it doesn’t works correctly, replace with another one.
5.1 Causes and Solutions • spirobank G does not switch on Check that battery is correctly inserted in the compartment on the back of the instrument. If it is correctly positioned then replace it with new one. • During operation the machine switches itself off and on again Change the battery. • At the end of spirometry testing the test data is incorrect Clean the turbine and then control it; use a new turbine. • All data in memory lost due to an unforeseeable event All data in memory has been deleted.
srl MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125, 00155 Roma - ITALY Declaration of CE Conformity Quality Management System according to the requirements of Annex II of the Medical Device Directive 93/42/EEC implemented by the Legislative Decree 46 dated 24/02/97 Notified Body CERMET No. 0476 - Certificate No.
LIMITED WARRANTY CONDITIONS spirobank G, 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. The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase. The warranty is effective from date of sale which must be shown on the relevant sales invoice or proof of purchase.
ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES G spirobank G User Manual cod. 980026 Rev 2.
ANNEX 3 INFORMATION FOR ELECTROMAGNETIC ENVIRONMENT CORRECT USE IN AN Guidance and manufacturer’s declaration – electromagnetic emissions The spirobank G is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirobank G should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The spirobank G is intended for use in the electromagnetic environment specified below. The customer or the user of the spirobank G should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment – test level guidance Electrostatic Floors should be wood, concrete or ceramic ±6 kV contact ±6 kV contact discharge (ESD) tile.
distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the 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.
Recommended separation distances between portable and mobile RF communications equipment and the spirobank G The spirobank G is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
