Related Manuals for Medical International Research spirobank G
Summary of Contents for Medical International Research spirobank G
- Page 1 G User Manual User Manual Rev. 2.0 Issued on: 15/06/2009 Approved on: 15/06/2009 User Manual cod. 980026 Rev 2.0 Page 1 of 46 spirobank G...
- Page 2 The winspiroPRO PC software supplied with the device MUST be installed correctly to the PC before connecting spirobank G 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 User Manual cod. 980026 Rev 2.0 Page 3 of 46 spirobank G...
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Page 4: Table Of Contents
Product description ..................13 Technical specifications ..................15 1.5.1 Features of the spirometer ................15 1.5.2 Other features ....................16 FUNCTIONING OF THE spirobank G ................17 Keyboard ......................17 Battery Level ......................19 Information ......................19 Service menu ....................... 20 2.4.1 Turbine Calibration .................. - Page 5 PROBLEM SOLVING ...................... 38 Causes and Solutions ..................39 LIMITED WARRANTY CONDITIONS ..................41 ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES ..........42 ANNEX 3 INFORMATION CORRECT ELECTROMAGNETIC ENVIRONMENT ........................43 User Manual cod. 980026 Rev 2.0 Page 5 of 46 spirobank G...
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Page 6: Introduction
INTRODUCTION 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;... -
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. User Manual cod. 980026 Rev 2.0 Page 7 of 46 spirobank G... -
Page 8: Important Safety Warnings
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. -
Page 9: Mouthpiece
30 mm, they are commonly used and in general easily procured. To avoid environmental contamination caused by the disposal of used mouthpieces, the user must follow all the relevant local regulations. User Manual cod. 980026 Rev 2.0 Page 9 of 46 spirobank G... -
Page 10: Device
(CT) equipment. If the PC and/or the printer connected to spirobank G 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 11: Labels And Symbols
CE mark in compliance with the Directive 93/42 EEC. • Electrical safety symbol • Warning symbol for the WEEE • prescription use label • indication about FCC 1.4.2 CE mark for medical devices 0476 User Manual cod. 980026 Rev 2.0 Page 11 of 46 spirobank G... -
Page 12: Electrical Safety Symbol
User Manual cod. 980026 Rev 2.0 Page 12 of 46 spirobank G... -
Page 13: Product Description
PC or to a printer using any one of several available methods: USB, Bluetooth. spirobank G 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 sufficient for over 6000 spirometry tests. - Page 14 The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects. spirobank G can also be connected to a PC (or to another computerised system) to configure the system. All spirometric test results plus the related subject details stored inside the device can be transferred from the device to the PC and then viewed on the PC (Flow/volume curves, spirometry parameters).
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Page 15: Technical Specifications
MVVcal Maximum voluntary ventilation calculated on FEV1 Slow vital capacity (expiratory) Slow espiratory vital capacity Slow inspiratory vital capacity Inspiratory capacity (max between EVC and IVC - ERV) User Manual cod. 980026 Rev 2.0 Page 15 of 46 spirobank G... -
Page 16: Other Features
Safety level in the presence of Device not suitable inflammable anaesthetic gas, oxygen or nitrogen Device for continuous use Conditions of use Temperature: MIN -20 °C, MAX + 60 °C Storage conditions User Manual cod. 980026 Rev 2.0 Page 16 of 46 spirobank G... -
Page 17: Functioning Of The Spirobank G
Electrical Safety Standard IEC 60601-1 Electro Magnetic Compatibility IEC 60601-1- Applied norms FUNCTIONING OF THE SPIROBANK G Keyboard The spirobank G keyboard is composed of 5 keys: Key functions are as followed: esc/ok previous page OSD key Scroll left OSD key... - Page 18 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...
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Page 19: Battery Level
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. If spirobank G is powered by a USB connection to a PC, the aforementioned function is disabled and... -
Page 20: Service Menu
It is not possible to create new patients until the archive is cancelled (see paragraph 2.4); download the test archive to the PC before proceeding. 2.4 Service menu Switch on spirobank G by pressing and holding . Press to access the service menu. - Page 21 Service Menu. To return to the Service Menu display without making any changes press Date Format to select the required format and to enter and return to the Service Menu. Units Format User Manual cod. 980026 Rev 2.0 Page 21 of 46 spirobank G...
- Page 22 “Search Device” and then press spirobank G will start to search for Bluetooth devices in the area; when one or more devices are found the screen will display the names of the device(s) found, press...
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Page 23: Turbine Calibration
If the difference in percentage between the expected value and the measured value is greater than 10% then it is not possible to continue the calibration procedure, this means that the turbine is damaged or requires cleaning. User Manual cod. 980026 Rev 2.0 Page 23 of 46 spirobank G... - Page 24 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 G 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 25: Subject Data
2.5 Subject Data Switch on spirobank G by pressing , or if already switched on, press icon); to access the “PATIENT DATA MANAGEMENT” screen, the following table describes the functions and icons. Icon Description To enter new patient data Go to the main screen To modify data of current subject To make a bronchodilator test (i.e. -
Page 26: Displaying Data From Memory
To return to the main screen Display the last spirometry tests of the selected patient Access data in memory Enter the search menu ( ) to display data based on four different methods: User Manual cod. 980026 Rev 2.0 Page 26 of 46 spirobank G... - Page 27 To show data of the selected test press twice Choosing a test with icon) the following screen appears: User Manual cod. 980026 Rev 2.0 Page 27 of 46 spirobank G...
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Page 28: Online Operating Mode (Connected To A Pc)
Connect the unit to a PC using the USB cable or the Bluetooth system. spirobank G thus acts as an intelligent sensor for flow and volume measurement while the PC controls its functions, including the switching on and off of the unit. - Page 29 • 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. The display should be facing the user; • Insert the mouthpiece well into the mouth beyond the teeth, being careful to ensure that air cannot escape from the sides of the mouth;...
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Page 30: Fvc Test
The test may be repeated several times by repeating the cycle without taking the mouthpiece out of the mouth, in which case spirobank G recognises the best test (FVC+FEV1) and will automatically show the results of this best test. -
Page 31: Vc Test
(green, yellow, red). For each test made, an arrow on the right of the screen indicates the worst level of interpretation of the test session. The connection between the traffic light colour and the test interpretation is shown below: User Manual cod. 980026 Rev 2.0 Page 31 of 46 spirobank G... - Page 32 F= No acceptable (1) FEV1 manoeuvres Acceptable manoeuvre means: good start and satisfactory exhalation (duration and flow) Where several comments related to the single test are calculated, spirobank G will only show the most important to facilitate the test interpretation.
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Page 33: Viewing The Spirometric Parameters
BLOW OUT ALL AIR IN LUNGS Between two tests, spirobank G evaluates the repeatability of the following parameters: repeatable when the difference between the two largest PEF is ≤ 0.67 L/s;... -
Page 34: Post Test, After Administration Of Drug
POST. A new test code ID is allocated. The interpretation is not based on the previous sessions with different drug doses; only the new test is utilized for the interpretation. User Manual cod. 980026 Rev 2.0 Page 34 of 46 spirobank G... -
Page 35: Data Transmission
The Bluetooth system enables spirobank G to transfer test data directly to a Bluetooth enabled printer. Proceed as follows: • From the main screen select the test to be printed with •... -
Page 36: Upgrade Internal Software
“winspiroPro” software manual. WARNING This function is only applicable via USB connection. MAINTENANCE spirobank G is an instrument that requires very little maintenance. The operations to perform periodically are: • Cleaning and controlling of the reusable turbine. - Page 37 • Switch on spirobank G as if to make a spirometry test (for example FVC) • Hold spirobank G 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 regular beep that...
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Page 38: Changing The Batteries
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. -
Page 39: Causes And Solutions
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. - Page 40 Directive 93/42/EEC implemented by the Legislative Decree 46 dated 24/02/97 Notified Body CERMET No. 0476 - Certificate No. MED – 9826 MIR srl Medical International Research, declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the Council Directive 93/42/EEC Annex I.
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Page 41: Limited Warranty Conditions
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. -
Page 42: Annex 1 Spirometry Test Report Examples
ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES User Manual cod. 980026 Rev 2.0 Page 42 of 46 spirobank G... -
Page 43: Annex 3
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. Electromagnetic environment – guidance... -
Page 44: 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. Electromagnetic environment –... - Page 45 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 G is used exceeds the applicable RF compliance level above, the spirobank G 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.
- Page 46 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. The customer or the user of the spirobank G can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the spirobank G as recommended below, according to the maximum output power of the communications equipment.
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