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Table of Content

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1-800-678-5782    1-508-238-7033

www.sdidiagnostics.com

6

The Spirometry Source

6.0

UPKEEP,  PREVENTIVE AND CORRECTIVE

MAINTENANCE ........................................................ 100

6.1

UPKEEP .................................................................. 101

6.2

PREVENTIVE MAINTENANCE .................................... 103

7.0

LIMITED WARRANTY CONDITIONS ......................... 105

8.0

SPIROMETRY INDICATIONS ................................... 106

Summary of Contents for Astra 300

Page 1: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 1 The Spirometry Source User s Manual...

Page 2: ...www sdidiagnostics com Table of Conten ts 2 The Spirometry Source Distributed by SDI Diagnostics Inc 10 Hampden Drive Easton MA 02375 National Sales 1 800 678 5782 1 508 238 7033 Email sales sdidiagn...

Page 3: ...Source TABLE OF CONTENTS SAFETY 7 1 INSTRUCTIONS FOR USE AND INSTALLATION 9 1 1 INTRODUCTION 10 1 2 LAYOUT OF CONTROLS PILOT LIGHTS AND CONNECTORS 11 1 3 INSTALLATION AND START UP 12 1 4 OPERATING MOD...

Page 4: ...2 3 EQUIPMENT PROTECTION 29 2 4 PERFORMING SPIROMETRY 31 2 5 FORCED VITAL CAPACITY FVC TEST PROCEDURE 33 QC GRADES 46 2 6 SLOW VITAL CAPACITY VC TEST PROCEDURE 53 2 7 MAXIMUM VOLUNTARY VENTILATION MVV...

Page 5: ...2 EXPORTING TESTS TO OTHER SYSTEMS 83 3 3 INSTALLING ASTRAPRO SPIROMETRY SOFTWARE FOR PC 83 4 TECHNICAL SPECIFICATIONS 85 4 1 TYPES OF TEST FUNCTIONS AND PARAMETERS 86 4 2 MEASURING SYSTEM 90 4 3 MIC...

Page 6: ...8 5782 1 508 238 7033 www sdidiagnostics com 6 The Spirometry Source 6 0 UPKEEP PREVENTIVE AND CORRECTIVE MAINTENANCE 100 6 1 UPKEEP 101 6 2 PREVENTIVE MAINTENANCE 103 7 0 LIMITED WARRANTY CONDITIONS...

Page 7: ...er power sources not indicated in this manual EFFECTS ON PATIENTS USING THE SPIROMETER The spirometry tests require patient cooperation Complete forced expiration is required to obtain meaningful pati...

Page 8: ...e connected to this device To connect ASTRA 300 to a non medical device with a ground conductor you must install an additional ground conductor to the non medical device The equipment must be stored a...

Page 9: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 9 Chapter 1 Instructions for Use and Installaton The Spirometry Source 1 INSTRUCTIONS FOR USE AND INSTALLATION...

Page 10: ...ni USB B 5 Pins USB 1 2 AA 1 5 V Alkaline Battery 1 Turbine Transducer 1 Cable Mini USB External Printer Option 29 5310 1 Quick Reference Card Astra 300 29 5002 29 7990 29 7966 29 5021 29 5023 29 5003...

Page 11: ...ton The Spirometry Source 1 2 LAYOUT OF CONTROLS PILOT LIGHTS AND CONNECTORS 1 2 6 7 8 9 3 4 5 1 On off button 2 Graphic LCD display 3 Turbine transducer 4 USB connection 5 RS 232 series connection 6...

Page 12: ...ies and the charger In both cases the battery charge will depend on the quality of the batteries used 1 5 V alkaline batteries or 2400 mAh rechargeable batteries will last for approximately 40 hours T...

Page 13: ...Installaton The Spirometry Source Atmospheric conditions The atmospheric working conditions are Ambient temperature between 10 and 40 C 50 and 104 F The American Thoracic Society recommends 17 to 40 C...

Page 14: ...k and will switch off On restarting it a screen will appear requesting the unlock code Call SDI s technical service department for the unlock code at 1 800 678 5782 START UP To start the ASTRA 300 spi...

Page 15: ...truly intuitive for any clinician All functions are accessed using the icons on the screen using the supplied stylus The spirometer may be connected to an external printer when this has been previousl...

Page 16: ...Chapter 1 Instructions for Use and Installaton The Spirometry Source Calibration Internal Database to save tests with alphanumeric and graphical data depending on model Maintenance Warnings LCD contr...

Page 17: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 17 Chapter 2 Astra 300 Functional Operation The Spirometry Source 2 ASTRA 300 FUNCTIONAL OPERATION...

Page 18: ...g on screen The character number or letter must also be selected for insertion in the numeric or alphanumeric fields using the stylus WARNING It is recommended to use only the stylus included with you...

Page 19: ...in FVC Volume Time Curve Maneuver selection Select the best maneuver Maneuver data selected Memory for five maneuvers Deleting a maneuver Interpretation Saving test for Post Bronchodilation Saving te...

Page 20: ...ng in the report Selecting the printer type Spirometry customization Parameters of reference and ethnic factor Observed parameters FVC VC MVV Graph selection Saving graphs on the database Printing FVC...

Page 21: ...dware Checking with standard curves FVC VC MVV Others Notifies ProgramUpdate key and allows System initialization PULSE OXIMETRY Test data Patient Code Full name Age height weight and sex Configuratio...

Page 22: ...ed on their requirements The different options included in the Customization Menu are explained in detail in the previous section To access this option press in the main menu then again from the Setup...

Page 23: ...age range selected for adults if a different table is chosen for children Extrapolates the values for the ages outside the selected table range Observed Parameters Allows for the observed parameters...

Page 24: ...lect Alerts displayed for maneuvers not compliant with ATS ERS or NLHEP criteria Date of latest calibration STANDARD CONFIGURATION This option memorizes a user defined customization program status to...

Page 25: ...omization Common customization Spirometry customization Pulse oximetry customization Protection customization as described in this section 2 Go back to the Standard Configuration option and press the...

Page 26: ...uipment clock time and date or Mode alphanumeric or numeric or Battery type alkaline or NiMh This selection only affects how the battery voltage level is calculated Select language Spanish or English...

Page 27: ...tion tick the PIN Enabled checkbox and enter the PIN in the New Pin boxes To change the PIN you must enter the current one in the Current Pin box If an erroneous PIN is entered three times the equipme...

Page 28: ...Source DATABASE CUSTOMIZATION This option allows you to choose the number of registers to be advanced if performing a fast advance using the database search engine Also allows for saving three maneuve...

Page 29: ...ll appear when it is started Enter the PIN and press If the PIN configured in Equipment Protection Customization is entered access will be given to the ASTRA300 and the main screen will appear If an e...

Page 30: ...ode is entered the ASTRA300 will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN 0000 If an incorrect code is entered th...

Page 31: ...nt remove them Explain clearly and in simple terms that they will be performing a breathing evaluation Try to avoid the word test since this has connotations of passing or failing and may make the pat...

Page 32: ...e during the third phase Draw the patient s attention to the audio tone of the flow sensing spirometers which shows that he or she is continuing to get out some air Patients should be quietly told to...

Page 33: ...on will be given in this section ENTERING PATIENT PARAMETERS Turn on ASTRA300 spirometer using the key wait for the Main Screen to appear and press One of the following screens will appear depending o...

Page 34: ...ic Factor is used in areas without their own reference parameters and the data needs to be corrected to a specific percentage This factor MUST BE SET TO 100 IF NOT USED and can only be modified throug...

Page 35: ...he maneuver Save the maneuver to the database Modify the patient s details Next view the second group of buttons Back view the first group of buttons Delete the maneuver Display the maneuver interpret...

Page 36: ...eport Pressing on the graph area makes the buttons disappear and makes it larger or smaller or Makes the graph larger or smaller Pressing on the REF area top left border of the screen accesses the pat...

Page 37: ...as his cooperation is vital for the test to provide meaningful data Patients can carry out the spirometry maneuvers in either of two different ways In the first method the patient breathes normally th...

Page 38: ...on the screen Then start the spirometry maneuver The maneuver underway can be ended at any time by pressing the key The equipment is held so that the technician can see the screen while the patient i...

Page 39: ...or less than 3 seconds in patients 10 years of age or less EX Indicates that the start of expiration was not satisfactory as the extrapolated volume is above 5 of the FVC or 0 15 liters The ATS ERS re...

Page 40: ...is indicates that the last maneuver entered is worse than the five saved and will be deleted If three or more maneuvers have been completed and the FVC and or FEV1 signs are flashing this indicates th...

Page 41: ...Select and view different maneuver Display the interpretation of the selected maneuver Print the report on the selected maneuver Save the selected maneuver in the database or Display the remaining pa...

Page 42: ...bronchodilation test or for the Internal Database The technician has the option to override this selection TYPE OF INTERPRETATION The ASTRA300 spirometer has as part of the firmware a selection of in...

Page 43: ...urther Testing Required Severity according to Pred FEV1 Obstructive Normal Significant Response FEV1 and or FVC 12 of baseline and 200 mL No Interpretation Yes Yes No No FEV1 FVC LLN Yes No Mild Pred...

Page 44: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 44 Chapter 2 Astra 300 Functional Operation The Spirometry Source...

Page 45: ...s Diagnosis This is based on the following criteria If FVC 80 of the FVC Reference and FEV1 80 of the FEV1 Reference Values in the range of reference Normal Diagnosis If FEV1 FVC FEV1 FVC Reference an...

Page 46: ...ceeds the base FEV1 or PRE by 15 this is considered a positive response to the bronchodilator QC GRADES Quality Control grades will be assigned according to the following guideline A At least 2 accept...

Page 47: ...ave different tests which can subsequently be transferred to a PC Database The maneuver selected by default is the best M1 If you want to save another it must first be selected Once the maneuver to be...

Page 48: ...PRE bronchodilator mode to then compare with a test in POST bronchodilator mode The process is similar to that described above Once the maneuver to be saved on the database has been selected press the...

Page 49: ...neuver to be printed flashing from the test screen and press The best M1 is recommended The following screen will then indicate printing in progress The printer will present a report similar to the on...

Page 50: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 50 Chapter 2 Astra 300 Functional Operation The Spirometry Source...

Page 51: ...due to questionable patient effort or for any other reason The maneuver selected by default is the best M1 If you want to delete another it must first be selected Select the maneuver to be deleted fl...

Page 52: ...The spirometer saves the best maneuver of each FVC VC MVV and or bronchodilator test to print a general report CHANGE PATIENT DATA ENTER NEW PATIENT This option is used to change some details of an e...

Page 53: ...ess the VC test by pressing the key from the main screen and perform a maneuver 2 The axes are always displayed in VOLUME TIME mode 3 Instruct the patient as to how to perform the test as the cooperat...

Page 54: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 54 Chapter 2 Astra 300 Functional Operation The Spirometry Source 6 The reporting of parameters and graphs is as shown below...

Page 55: ...OCEDURE with the following variations 1 Access the MVV test by pressing the key from the main screen and perform a maneuver 2 The axes are displayed in VOLUME TIME mode 3 Instruct the patient as to ho...

Page 56: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 56 Chapter 2 Astra 300 Functional Operation The Spirometry Source...

Page 57: ...ilator mode and saved to the PRE database The procedure to carry out POST Bronchodilator spirometry is as follows 1 Complete an FVC VC or MVV test with the patient as described in the previous section...

Page 58: ...Astra 300 Functional Operation The Spirometry Source POST Using keys and the VC and MVV tests can be seen and saved in PRE mode 5 Select the PRE test with which it is to be compared and press The scre...

Page 59: ...nd POST mode and the method of comparison between them depending on the option selected in customization See section 2 2 EQUIPMENT CUSTOMIZATION Weighted between PRE and POST between REF Predicted and...

Page 60: ...1 800 678 5782 1 508 238 7033 www sdidiagnostics com 60 Chapter 2 Astra 300 Functional Operation The Spirometry Source...

Page 61: ...ation 1 Turn on the spirometer 2 From the Main Menu press Setup this will bring you the SETUP UTILITIES menu Press Setup again to bring you to the CUSTOMIZATION menu 3 Press DB and ensure that Save 3...

Page 62: ...default and the number of pulses is the same as that engraved on the side of the turbine press Enter In the Calibration measuring screen press CAL CHECK 4 Push to empty the syringe then pull out the p...

Page 63: ...chanical elements over time and cause a change in the spirometer calibration factors Hence a calibration system has been incorporated based on a reference volume signal e g a syringe The Astra 300 inc...

Page 64: ...calibrations the details of the last one will appear in the title Enter the necessary data Volume between 0 and 6 liters depending on the syringe volume If a 0 is entered the default factors are used...

Page 65: ...he turbine body Although variability between turbines is within 3 it is worth entering this factor in the spirometer if the turbine is changed to obtain the maximum measurement precision Temp ambient...

Page 66: ...o high or too low Where this is not the case you will be told to repeat the maneuver The time for each cycle must be no less than three seconds and no more than six 5 The screen shows the expiratory a...

Page 67: ...ibrations performed This is extremely useful for centers requiring a quality control of the processes they use To do so press on the first calibration process screen The following screen will appear D...

Page 68: ...storage or management The base information remains even when the equipment is unplugged The tests that can be saved using a six second FVC as reference are Database H 1100 The saving of the tests has...

Page 69: ...e Spirometry Source 3 Search for a register 4 Print a summarized report 5 Delete the database To do so turn on the ASTRA 300 using the key and wait for the following screen to appear Press to access t...

Page 70: ...ional Operation The Spirometry Source Go back to the main screen Search for register Search the database Summarized report Delete the database DATABASE SEARCH Select option to display the tests saved...

Page 71: ...wards through the registers The movement value is configured in the Customization menu Deletes the test selected Displays the test selected and Moves around the different tests Select a test and press...

Page 72: ...e Pressing the graph area makes the buttons disappear and makes the graph larger or smaller PATIENT SEARCH Select the option to search for a patient in the database The following screen will appear En...

Page 73: ...nostics com 73 Chapter 2 Astra 300 Functional Operation The Spirometry Source SUMMARIZED REPORT Select the option to print a report with the list of tests saved on the database The following screen wi...

Page 74: ...apter 2 Astra 300 Functional Operation The Spirometry Source DELETE DATABASE Select the option to delete the database The following message will appear Press to accept and delete the database or press...

Page 75: ...n how to configure your spirometer to meet your needs Choose the comprehensive pre set program or custom design your own program from a number of selections for testing interpreting or reporting To ad...

Page 76: ...maintenance work the tests performed and the tests performed since the last maintenance work Press This screen defines the periods in days between calibrations or between preventive maintenance work...

Page 77: ...etry Source Go back to the previous screen Black background white content White background black content Validate choice and Increase decrease contrast EQUIPMENT CHECK Select the option to check diffe...

Page 78: ...ters will be printed Check that the automatic on and off work properly Upon selecting this option the equipment switches off and on automatically after 5 seconds Display the values of different variab...

Page 79: ...iven on the screen Touch Screen STANDARD CURVES Select the option to check the working order of the equipment through certain pre saved curves Select the curve type and follow the instructions on the...

Page 80: ...ect the option to configure different options for the equipment Go back to the previous screen Reset all equipment variables Reindex the database Change from positive VC to negative VC and vice versa...

Page 81: ...Chapter 3 Communications System The Spirometry Source 81 1 800 678 5782 1 508 238 7033 www sdidiagnostics com 3 COMMUNICATIONS SYSTEM...

Page 82: ...the PC using the W 20 Software BATCH option 4 The screen shows a list of the tests transferred and you can select those to be imported to the PC Database selected in the AstraPro Software Configurati...

Page 83: ...king it compatible with many different systems The information is available in the following files TESTS TXT Contains the database tests GRAPHICS TXT Contains the graphs in Flow Time mode The graph fi...

Page 84: ...options First Find best controller for your device Second Show a list of all controllers in a location Select the Second and click on Next 5 Now a screen will appear which allows you to select betwee...

Page 85: ...Chapter 4 Technical Specifications The Spirometry Source 85 1 800 678 5782 1 508 238 7033 www sdidiagnostics com 4 TECHNICAL SPECIFICATIONS...

Page 86: ...apacity FEV 5 l Forced Expiratory Volume in 5 seconds FEV1 l Same in 1 second FEV3 l Same in 3 seconds FEV 5 FVC Ratio FEV1 FVC Ratio FEV3 FVC Ratio FEV1 VC Ratio PEF l s Peak Expiratory Flow FEF25 l...

Page 87: ...lume MVVInd l min Maximum Voluntary Ventilation 30 x FEV1 FEV6 l Forced Expiratory Volume in 6 seconds FEV1 FEV6 Ratio EPOC rate Parameter that depends on the number of cigarettes smoked a day the age...

Page 88: ...maneuver SLOW VITAL CAPACITY Parameters VC l Slow vital capacity TV l Tidal volume ERV l Expiratory Residual Volume IRV l Inspiratory Residual Volume IC l Inspiratory Capacity Ti s Inspiratory time Te...

Page 89: ...that can be selected from several authors Patient s ID details Temperature pressure and relative humidity details Graphs in VOLUME TIME mode Saving of five maneuvers from the same study POST BRONCHODI...

Page 90: ...pretation selection Report customization INTERNAL DATABASE Saving of spirometric and pulse oximetry tests Two types of databases based on storage capacity CLOCK CALENDAR Hour Minute Second Month Day Y...

Page 91: ...l s 0 122 to 14 l s Precision of measurements BTPS Volume the highest 3 or 50 ml Flow the highest 5 or 150 ml s Time related precision 0 5 Resolution in volume ml 6 Sampling frequency Hz 25 Turbine li...

Page 92: ...Start FVC expiration Using the back extrapolation method End FVC expiration When the volume accumulated in the last second is below 0 025 litres FVC test selection Based highest value of FVC or on op...

Page 93: ...and white or color printers 4 4 PRESENTATION OF DATA High resolution touch screen LCD Liquid Crystal Display with 240 x 160 pixel array By external printer By PC with the corresponding software 4 5 TE...

Page 94: ...ards Spirometry ATS ERS SEPAR Safety EN 60601 1 EN 60601 1 1 Electro magnetic Compatibility EN 60601 1 2 See Appendix 1 Quality EN 13485 ISO 9001 2000 Spirometers for peak expiratory flow UNE EN 13826...

Page 95: ...Chapter 5 Operating Principle s s s s s The Spirometry Source 95 1 800 678 5782 1 508 238 7033 www sdidiagnostics com 5 OPERATING PRINCIPLES...

Page 96: ...urbine is axial with two stators in the form of a propeller and a rotor made up of a flat rectangular blade The shape of the stators means that the air flow passing turns which makes the blade turn Th...

Page 97: ...FLASH memory Non volatile 512 KByte RAM to save the equipment configuration status variables and calibration database Central Processing Unit CPU Communications controller RS232 USB and Bluetooth wit...

Page 98: ...ontroller QUALITATIVE DESCRIPTION The control program is responsible for ensuring the spirometry signals are handled in line with the applicable standards particularly the calculation of Identificatio...

Page 99: ...508 238 7033 www sdidiagnostics com Any aging of or accumulated dirt in the turbine transducer may lead to imprecise measurements To ensure the turbine measures correctly the system includes a simple...

Page 100: ...Chapter 6 Upkeep Preventive Corrective Maintenance The Spirometry Source 100 1 800 678 5782 1 508 238 7033 www sdidiagnostics com 6 UPKEEP PREVENTIVE AND CORRECTIVE MAINTENANCE...

Page 101: ...The equipment user normally performs this The operations to be completed are as follows CLEANING THE TURBINE TRANSDUCER ATTENTION to avoid the risk of cross contamination when using turbine with plai...

Page 102: ...eplace Step 2 by submerging it in a glutaraldehyde solution or similar for 10 minutes follow the manufacturer s instructions PRECAUTION DO NOT EXPOSE THE TURBINE TO TEMPERATURES OF OVER 60 C OR BELOW...

Page 103: ...perfectly connected that no cable and or connector or any other element is broken or damaged In the event of detecting any problem that the user cannot solve contact the SDI Diagnostics Repair Departm...

Page 104: ...nostics Inc as the manufacturer must provide written authorization for at least the guarantee period for the corresponding technical personnel to carry out said maintenance and will not be held liable...

Page 105: ...nt safety norms in the country of installation If the product is utilized differently from the use described in the Users Manual If any alteration adjustment modification or repair has been carried ou...

Page 106: ...ment of patients receiving bronchodilator treatments Determination and or documentation of pulmonary disability Asthma diagnosis Pre existing pulmonary disease Frequent colds Assessment of congestive...

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