SDI Astra 300 User Manual
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SDI Astra 300 User Manual

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

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  • Page 1 The Spirometry Source User’s Manual 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 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@sdidiagnostics.com Fax: 1-508-230-2752 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 3: Table Of Contents

    The Spirometry Source TABLE OF CONTENTS SAFETY ................7 INSTRUCTIONS FOR USE AND INSTALLATION .... 9 INTRODUCTION ............10 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS ............11 INSTALLATION AND START-UP........12 OPERATING MODES ..........15 CAUTION: Federal law restricts this device to sale by or on the order of a physician! 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 4 The Spirometry Source ASTRA 300 FUNCTIONAL OPERATION ....... 17 FUNCTION TREE ............18 EQUIPMENT CUSTOMIZATION ........22 EQUIPMENT PROTECTION ......... 29 PERFORMING SPIROMETRY ........31 FORCED VITAL CAPACITY «FVC» TEST PROCEDURE ............33 QC GRADES ............... 46 SLOW VITAL CAPACITY «VC»...
  • Page 5 The Spirometry Source COMMUNICATIONS SYSTEM ........81 PATIENT TEST MANAGEMENT IN THE PC ....82 EXPORTING TESTS TO OTHER SYSTEMS ....83 INSTALLING ASTRAPRO SPIROMETRY SOFTWARE FOR PC ..............83 TECHNICAL SPECIFICATIONS ........85 TYPES OF TEST, FUNCTIONS AND PARAMETERS ..86 MEASURING SYSTEM ..........
  • Page 6 The Spirometry Source UPKEEP, PREVENTIVE AND CORRECTIVE MAINTENANCE ............100 UPKEEP ..............101 PREVENTIVE MAINTENANCE ........103 LIMITED WARRANTY CONDITIONS ......105 SPIROMETRY INDICATIONS ........106 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 7: Safety

    The ASTRA 300 spirometer has been designed for use with safety in mind. All operating instructions must be read before using the ASTRA 300. Failure to do so may lead to injuries to the user or the patient and damage to equipment and/or accessories.
  • Page 8 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.

  • Page 9: Instructions For Use And Installation

    The Spirometry Source . INSTRUCTIONS FOR USE AND INSTALLATION 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 10: Introduction

    The Spirometry Source 1.1 INTRODUCTION The Astra 300 spirometer is a compact device with a high-resolution graphic touch screen. It functions using accurate and precise turbine transducers and may be be connected to an external printer via USB. The entire system is controlled by a microprocessor for the acquisition, calculation and presentation of alphanumeric and graphical data.

  • Page 11: Layout Of Controls, Pilot Lights And Connectors

    The Spirometry Source 1.2 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS 1- On/off button 2- Graphic LCD display 3- Turbine transducer 4- USB connection 5- RS·232 series connection 6- Specifications plate 7- Lithium battery (CR1632) 8- Firmware loading switch 9- Main batteries (2xAA 1.5V) 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 12: Installation And Start-Up

    The Spirometry Source 1.3 INSTALLATION AND START-UP Astra 300 INSTALLATION The ASTRA 300 spirometer is CLASS IIa according to the criteria of the 93/42/EEC European Medical Device Directive and, in line with the type of protection against electric shocks established by the EN60601.1 standard, the equipment is rated as CLASS IP type B.
  • Page 13 The Spirometry Source Atmospheric conditions The atmospheric working conditions are: •Ambient temperature between 10 and 40 ºC (50 and 104 ºF) (The American Thoracic Society recommends 17 to 40 ºC) • Relative humidity below 75% (without condensation) •Atmospheric pressure from 430 to 800 mmHg 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 14 The Spirometry Source EQUIPMENT PROTECTION To insure the security of patient data, the ASTRA 300 has an equipment protection option accessed by PIN.This option can be customized, enabled or disabled as required. Where enabled, a screen will appear requesting the PIN (user-configured) when the equipment is turned on.

  • Page 15: Operating Modes

    The Spirometry Source NOTE: The first time the equipment is started, the protection is disabled and the PIN is set to 0000. See Section 2.2/3.2 EQUIPMENT CUSTOMIZATION to enable it and configure the PIN. HANDLING THE EQUIPMENT The spirometer has been designed to be simple to operate. Although it allows a number of functions, its unique navigation properties will quickly demonstrate that it is truly intuitive for any clinician...
  • Page 16 The Spirometry Source •Calibration •Internal Database to save tests with alphanumeric and graphical data (depending on model). •Maintenance . Warnings . LCD contrast . Equipment check . Equipment configuration . ATS curves 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 17: Astra 300 Functional Operation

    The Spirometry Source . ASTRA 300 FUNCTIONAL OPERATION 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 18: Function Tree

    WARNING It is recommended to use only the stylus included with your ASTRA300 spirometer. SDI Diagnostics is not responsible for any damage caused where other styli are used. Pointed objects must not be used under any circumstances.
  • Page 19 The Spirometry Source SPIROMETRY •Forced Vital Capacity «FVC» Test Test data Patient Code Full name Age, height, weight and sex Smoker index Ethnic factor Barometric Pressure Temperature Start of the spirometric maneuver Graph presentation Flow/Volume Loop or Curve (only in FVC) Volume/Time Curve Maneuver selection Select the best maneuver...
  • Page 20 The Spirometry Source •Deleting a test •Summarized printing of the tests saved CUSTOMIZATION •Standard Configuration Retrieving the configuration Saving the configuration •Database customization Number of registers •Common customization Setting the clock Patient code and others Numeric Alphanumeric Battery type Operating language Entering a heading in the report Selecting the printer type •Spirometry customization...
  • Page 21 The Spirometry Source MAINTENANCE •Alerts selection Period between calibrations Period between maintenance work •Adjusting the LCD contrast •Checking hardware •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 •Configuration...

  • Page 22: Equipment Customization

    The Spirometry Source 2.2 EQUIPMENT CUSTOMIZATION Because of the wide variety of options available, users should customize their ASTRA300 spirometer based on their requirements. The different options included in the Customization Menu are explained in detail in the previous section. Setup To access this option, press in the main menu,...
  • Page 23 The Spirometry Source SPIROMETRY CUSTOMIZATION This option customizes any suboptions specific to the spirometric tests Pred Actual Post Predicted Values Pred Allows selecting among several authors for children and adults Prioritizes the age range selected for adults if a different table is chosen for children. Extrapolates the values for the ages outside the selected table range.
  • Page 24 The Spirometry Source Mode of comparison between PRE Post bronchodilator and POST bronchodilator W Average weighted % between PRE and POST % between PRED and POST % Percentage between PRE and POST Dif. Difference between PRE and POST Alerts Select Alerts displayed for maneuvers not compliant with ATS/ERS or NLHEP criteria Date of latest calibration STANDARD CONFIGURATION...
  • Page 25 The Spirometry Source Follow the instructions below to save the Standard configuration: You can customize each of the following options: Database customization Common customization Spirometry customization Pulse oximetry customization Protection customization as described in this section. Go back to the Standard Configuration option and press the Save Your Standard Configuration has now been saved.
  • Page 26 The Spirometry Source COMMON CUSTOMIZATION Setup This option customizes certain suboptions that are common to any test made using the ASTRA300. Sets the internal equipment clock (time and date) Mode (alphanumeric or numeric) Battery type (alkaline or NiMh) This selection only affects how the battery voltage level is calculated Select language (Spanish or English) Enter a heading in the report...
  • Page 27 The Spirometry Source EQUIPMENT PROTECTION CUSTOMIZATION This allows you to change the PIN required to start the equipment (if the protection option is enabled) and to enable or disable equipment protection. The following screen appears on accessing this option To enable the protection, tick the PIN Enabled checkbox and enter the PIN in the New Pin boxes*.
  • Page 28 The Spirometry 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 maneuvers at once with the Occupational Health Module (see p.

  • Page 29: Equipment Protection

    The Spirometry Source 2.3 EQUIPMENT PROTECTION If equipment protection has been enabled, the following screen will 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.
  • Page 30 The Spirometry Source If the correct code 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, the equipment will remain locked.

  • Page 31: Performing Spirometry

    The Spirometry Source PERFORMING SPIROMETRY Before testing patients, it is important to keep in mind that spirometry is an effort-dependent test requiring the complete cooperation of the patient. In order to achieve this, you as the coach play a critical role. Be sure the patient is comfortable.
  • Page 32 This results in a lower FVC than normal and when interpreted, may suggest that the patient is restricted. Your SDI spirometer is designed to give you an audible “beep” when flow has reached a specific diminished threshold. The spirometer will also alert you with an error message when it sees an abrupt cessation of flow.

  • Page 33: Forced Vital Capacity "Fvc" Test Procedure

    The Spirometry Source 2.5 FORCED VITAL CAPACITY «FVC» TEST PROCEDURE The procedures to be completed to carry out the Forced Vital Capacity «FVC», slow Vital Capacity «VC» and Maximum Voluntary Ventilation «MVV» tests are very similar. Therefore, only one detailed description will be given in this section.
  • Page 34 Customization Program. If the NHANESIII predicted set has been chosen in the Customization section or if your Astra 300 is being operated in the PCP Mode, the default race chosen will be displayed and Race will appear next to the window First (First name): 20-character alphanumeric field corresponding to the patient’s name.
  • Page 35 The Spirometry Source ENTERING FORCED VITAL CAPACITY «FVC» TESTS Go back to the previous screen Start the 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 interpretation Print the maneuver report...
  • Page 36 The Spirometry Source •Pressing on the parameters displays the screen containing the data on the selected maneuver. •Pressing on a maneuver selects it. This allows you to see its graph, consult its parameters or print a report. •Pressing on the graph area makes the buttons disappear and makes it larger or smaller.
  • Page 37 The Spirometry Source When testing a patient, consider the following: It is highly recommended that a disposable filter or mouthpiece be used for patient testing. Check that the flter or disposable mouthpiece is correctly inserted into the spirometer, as in the figure INSERT FIRMLY Instruct the patient as to how the test should be...
  • Page 38 The Spirometry Source Press the key and wait until a flashing arrow appears 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 is carrying out the tests.
  • Page 39 The Spirometry Source At the end of the maneuver, one or more of the QC Warnings (if enabled in the Customization Program) may appear, alerting the technician as to whether the maneuver is in compliance with ATS or NLHEP Quality Control criteria.
  • Page 40 The Spirometry Source •The new curve is superimposed to compare it with the best (M1/ dotted line) of those saved. •As many maneuvers as required can be carried out. The ASTRA300 will always save the five best FVC and VC values and the three best values for MVV, according to ATS/ERS criteria •Different regulations recommend at least three...
  • Page 41 The Spirometry Source DISPLAYING RESULTS Press the parameter area. The data on the selected maneuver (M) will be displayed (M1 by default). PRED Go back to the previous screen 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 Display the remaining parameters, if...
  • Page 42 The Spirometry Source •It also displays: - The best FVC and FEV1 values that may correspond to different maneuvers. - Ethnic factor (if not used, this must be 100) - Warnings of non-compliance with ATS/ERS criteria for each maneuver. WARNING: As indicated, the BEST maneuver is set at M1.
  • Page 43 The Spirometry Source FEV1/FVC > LLN FVC > LLN Obstructive Severity according to Normal Possibly Restrictive % Pred FEV Further Testing Required Bronchodilation Test > and/or FVC 12% of baseline > 200 mL No Interpretation Significant Response “ > Mild” % Pred FEV >...
  • Page 44 The Spirometry Source 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 45 The Spirometry Source •Miller Diagnosis This presents the following information: NORMAL, RESTRICTIVE, OBSTRUCTIVE or COMBINED, according to the criteria of the following chart •Snider, Kory & Lyons Diagnosis This is based on the following criteria: If FVC > 80% of the FVC Reference and FEV1 >...

  • Page 46: Qc Grades

    The Spirometry Source FVC < 35% Very Intense If FEV1/FVC% < FEV1/FVC% Reference and FVC > 80% of the FVC Reference Mixed ventilatory disturbance is suspected If FEV1/FVC% < FEV1/FVC% Reference and FEV1 > 80% of the FEV1 Reference Mixed ventilatory disturbance is suspected If the POST bronchodilation test is carried out and the FEV1 POST degree of reversibility exceeds the base FEV1 or PRE by 15%, this is considered a positive response...
  • Page 47 The Spirometry Source SAVING FVC TESTS Saving a test in the Internal Database The ASTRA300 spirometer has an Internal Database that can save 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.
  • Page 48 The Spirometry Source Saving a test to compare in POST bronchodilator mode This option allows a test to be saved in 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 key on the test screen.
  • Page 49 The Spirometry Source PRINTING THE FVC The ASTRA300 spirometer can print any maneuver on an external HP PCL 6 compatible printer. The maneuver selected by default is the best (M1). If you want to produce a report on another, it must first be selected.
  • Page 50 The Spirometry Source 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 51 The Spirometry Source DELETING AN EXISTING MANEUVER With the ASTRA 300 spirometer, you may delete any maneuver, whether it is because you question the data value 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.
  • Page 52 The Spirometry Source OTHER TESTS ON THE SAME PATIENT You can do the following after carrying out the FVC test on a patient: •A VC test on the same patient •An MVV test on the same patient •A Post bronchodilator test on the same patient •Print the general report of all tests on the same patient •Enter data for a new patient.

  • Page 53: Slow Vital Capacity "Vc" Test Procedure

    The Spirometry Source 2.6 SLOW VITAL CAPACITY «VC» TEST PROCEDURE The procedure to carry out the Slow Vital Capacity «VC» test is similar to that described in section 3.4 FORCED VITAL CAPACITY «FVC» PROCEDURE with the following variations: Access the «VC» test by pressing the key from the main screen and perform a maneuver.
  • Page 54 The Spirometry Source The reporting of parameters and graphs is as shown below: 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 55: Maximum Voluntary Ventilation "Mvv Test Procedure

    The Spirometry Source 2.7 MAXIMUM VOLUNTARY VENTILATION «MVV TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation «MVV» test is similar to that described in section 3.4 FORCED VITAL CAPACITY «FVC» PROCEDURE with the following variations: Access the «MVV» test by pressing the key from the main screen and perform a maneuver.
  • Page 56 The Spirometry Source 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 57: Post Bronchodilator Spirometry Procedure

    The Spirometry Source 2.8 POST BRONCHODILATOR SPIROMETRY PROCEDURE The ASTRA 300 spirometer allows for spirometry tests to be performed after the administration of a bronchodilator drug. These tests may be done in in FVC, VC or MVV modes provided a test has previously been completed in PRE bronchodilator mode and saved to the PRE database.
  • Page 58 The Spirometry Source Using keys , the VC and MVV tests can be seen and saved in PRE mode. Select the PRE test with which it is to be compared and press The screen then shows the two graphs (PRE and POST) for comparison purposes: POST 1-800-678-5782 1-508-238-7033...
  • Page 59 The Spirometry Source Then continue as described in section 3.4 FVC TEST PROCEDURE. • The curve in POST bronchodilator mode is compared with the curve saved in PRE bronchodilator mode. • The data screen shows the observed values in PRE and POST mode and the method of comparison between them, depending on the option selected in customization.
  • Page 60 The Spirometry Source 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 61: Occupational Health Module

    The Spirometry Source 2.9 OCCUPATIONAL HEALTH (OHM) MODULE (if equipped) The Astra 300 Occupational Health settings will afford the user compliance with the standards for spirometry testing of National Institute for Occupational Safety and Health as outlined in the U.S Department of Labor Standard 1910.1043...
  • Page 62 1 Set up the spirometer and the syringe as in the Calibration instructions 2 Power up the Astra 300 using the (On) button and at the Startup menu, press (Setup) to bring you to the SETUP UTILITIES menu: Press the (CAL) button...

  • Page 63: Calibration Procedure

    Hence, a calibration system has been incorporated based on a reference volume signal (e.g. a syringe). The Astra 300 includes a Calibration Program for fast (less than one minute) and easy checking and auto- correcting of deviations in the measurements taken based on a standard or reference volume for the quality control of the different spirometric tests.
  • Page 64 The Spirometry Source Press to access the Setup Utilities screen Setup From the Setup Utilities screen press the The following screen will appear: If there are previous 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.
  • Page 65 The Spirometry Source If it is different, enter the number of turbine pulses. In this case, the factors will be recalculated and the calibration process completed. NOTE: Each turbine is factory calibrated individually and is associated with a factor equivalent to the pulses/ liter detected which is engraved on the turbine body.
  • Page 66 The Spirometry Source Press and start the calibration process. Empty the syringe for two or more consecutive cycles (one cycle is equal to emptying and refilling the syringe). When emptying and filling, the syringe plunger must move all the volume used as a reference. If this is not done correctly, the equipment will detect it as «incorrect maneuvers».
  • Page 67 The Spirometry Source CALIBRATION REGISTERING The spirometer has a register containing the expiratory and inspiratory factors of the last ten calibrations 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.

  • Page 68: Internal Database

    The Spirometry Source 2.11 INTERNAL DATABASE The Astra 300 has an Internal Database as standard that saves the different tests made using the equipment and subsequently displays them, prints them and/or transfers them to a PC or other computerized system for storage or management.
  • Page 69 The Spirometry Source Search for a register Print a summarized report Delete the database To do so, turn on the ASTRA 300 using the and wait for the following screen to appear: ASTRA Post Setup SP O Press to access the screen with the options to be chosen with the database.
  • Page 70 The Spirometry Source Go back to the main screen Search for register Search Search the database. Summarized report Delete the database. DATABASE SEARCH Search Select option to display the tests saved on the database Go back to the previous screen 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 71 The Spirometry Source Fast back/forwards through the registers. The movement value is configured in the Customization menu. Deletes the test selected Displays the test selected Moves around the different tests Select a test and press . The following screen is accessed: Go back to the previous screen Display test data...
  • Page 72 The Spirometry Source •Pressing the axes changes the type of graph (Flow/ Volume or Volume/Time). •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.
  • Page 73 The Spirometry Source SUMMARIZED REPORT Select the option to print a report with the list of tests saved on the database. The following screen will appear, indicating printing in progress: 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...
  • Page 74 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 to go back to the previous screen without deleting it. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 75: Maintenance Program

    The Spirometry Source 2.12 MAINTENANCE PROGRAM The equipment has a maintenance program. The Astra 300 is designed to provide a new level of sophistication in spirometry testing, giving you a wealth of choices in 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 .
  • Page 76 The Spirometry Source WARNINGS Select the option The following screen will appear with the information on the latest maintenance work, the tests performed and the tests performed since the last maintenance work. Press ALERTS This screen defines the periods in days between calibrations or between preventive maintenance work on the equipment.
  • Page 77 The Spirometry Source LCD CONTRAST Cont Select the option to configure the screen contrast. Go back to the previous screen Black background/white content White background/black content Validate choice Increase/decrease contrast EQUIPMENT CHECK Select the option to check different parts of the equipment.
  • Page 78 Go back to the previous screen Distributor details Pulse oximetry module Check the external printer selected. The SDI logo, heading lines and 10 lines of characters 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.
  • Page 79 The Spirometry Source Performs a test on the LCD. Follow the instructions given on the screen. Touch Screen Touch 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 screen, which are similar to the FVC, VC and MVV procedures.
  • Page 80 The Spirometry Source EQUIPMENT CONFIGURATION Select 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 •An updating key is also displayed, which is necessary for updating the firmware.

  • Page 81: Communications System

    The Spirometry Source . COMMUNICATIONS SYSTEM 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 82: Patient Test Management In The Pc

    The Spirometry Source One of the strengths of the ASTRA300 spirometer is its Communications System, which allows the user to: Transfer patient tests to a PC Export patient tests to other Management Systems Communications can be made using three different inputs when using the corresponding software: •...

  • Page 83: Exporting Tests To Other Systems

    The Spirometry Source 3.2 EXPORTING TESTS TO OTHER SYSTEMS The Astra 300 spirometer can export the tests saved previously in the Internal Database to other management systems at other locations. The equipment shows the information in comma- delimited mode, making it compatible with many different systems.
  • Page 84 The Spirometry Source To install the Software and Driver, follow these steps: Start up the spirometer (consult the corresponding manual for use). Insert installation CD and Run D:\Setup.exe (or appropriate cd drive) and follow prompts for cd installation. Open software and connect spirometer to PC with the USB cable.

  • Page 85: Technical Specifications

    The Spirometry Source . TECHNICAL SPECIFICATIONS 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 86: Types Of Test, Functions And Parameters

    The Spirometry Source The specifications given below are applicable in each case, depending on the model available, as indicated in detail in Section 1.3 SPIROMETER MODELS. 4.1 TYPES OF TEST, FUNCTIONS AND PARAMETERS FORCED VITAL CAPACITY FVC Parameters: • FVC Forced Vital Capacity •...
  • Page 87 The Spirometry Source • MIF50% (l/s) Maximum Inspiratory flow with 50% of FVC inspired • FIVC Forced Inspiratory Vital Capacity • FIV1 Forced Inspirometry Volume in 1 second • FIV1/FIVC Ratio • FEV1/FIV1 (%) Ratio • PIF (l/s) Inspiratory Flow Apex •...
  • Page 88 The Spirometry Source Graphs in FLOW/VOLUME and VOLUME/TIME Quality alerts to assure compliance with ATS/ERS criteria Saving of five maneuvers from the same study Acoustic and graphic indication of the start and end of each maneuver SLOW VITAL CAPACITY Parameters: •...
  • Page 89 The Spirometry Source MAXIMUM VOLUNTARY VENTILATION Parameters: • MVV (l/min) Maximum Voluntary Ventilation • Br./min (Br/min) Breathing frequency of MVV Percentage deviation relative to predicted values Standardized predicted values 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 BRONCHODILATION TEST...

  • Page 90: Measuring System

    The Spirometry Source Customization of the language, printer and report heading, etc. Spirometry customization Parameters of reference Observed parameters Graph selection Interpretation 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-Year...

  • Page 91: Micro Controller

    The Spirometry Source RANGES AND MEASUREMENTS Turbine •Measurement Scale (BTPS) Flow (l/s) 0 to ± 16 Volume (l) 0 to 10 •Dynamic flow resistance kPa/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...
  • Page 92 The Spirometry Source Volume accumulation time: •Five FVC curves with a maximum of 25 seconds each •Five VC curves with a maximum of 45 seconds each •Five MVV curves with a maximum of 15 seconds each Start FVC expiration: •Using the back extrapolation method End FVC expiration: •When the volume accumulated in the last second is below 0.025 litres...

  • Page 93: Presentation Of Data

    The Spirometry Source Communications channel: •RS 232C •USB 2.0 •Bluetooth 2.0 •Compatible with HP-PCL black 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 TEMPERATURE SENSOR Internal temperature sensor from 23 to 50 ºC ±...
  • Page 94 The Spirometry Source Temperature: •Storage, between 32 and 94 °F •Working, between 42 and 72 °F Applicable standards: •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 13826:2004) •Bluetooth Module - Compliance with Standard 2.0...

  • Page 95: Operating Principles

    The Spirometry Source . OPERATING PRINCIPLES 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 96: Turbine

    The Spirometry Source The Astra 300 spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical must be changed to electrical. The devices responsible for this change are called transducers.

  • Page 97: Microprocessor

    The Spirometry Source 5.3 MICROPROCESSOR PHYSICAL DESCRIPTION The microprocessor section is made up of a series of electronic devices that save, manage, receive and send data. In general terms, it is divided into: - Basic hardware control program (BIOS) residing in the internal Flash memory of the Micro controller (128 KBytes).
  • Page 98 The Spirometry Source This device manages and runs the process that is coded into the data that forms the program. The Renesas H8S2144 micro controller is used as a CPU. CONTROLLERS These are responsible for transferring data between the CPU and the other devices, i.e. the keypad, the screen and the printer.
  • Page 99 The Spirometry Source 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 checking procedure based on measuring the known volume of a calibration syringe. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 100: Upkeep, Preventive And Corrective Maintenance

    The Spirometry Source . UPKEEP, PREVENTIVE AND CORRECTIVE MAINTENANCE 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com...

  • Page 101: Upkeep

    The Spirometry Source Like any equipment, particularly if for medical applications, ASTRA 300 spirometer requires upkeep and maintenance to ensure the safety of patients, operators and the environment, and at ensuring the reliability and precision of the functions for which it has been developed.
  • Page 102 The Spirometry Source You can then leave it to dry at room temperature. Reassemble the turbine in the housing. Top level disinfection: If you suspect contamination, use one of the more complex antiseptic solutions. For example, replace Step 2 by submerging it in a glutaraldehyde solution (or similar) for 10 minutes (follow the manufacturer’s instructions).

  • Page 103: Preventive Maintenance

    THIS TECHNICAL CHECK SHOULD BE PERFORMED EVERY YEAR following the ASTRA 300 Verification and Adjustment Procedure available from the manufacturer. This type of operation must be carried out by skilled technical staff from the hospital’s maintenance...
  • Page 104 The Spirometry Source SDI Diagnostics, 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 under any circumstances for any damage, malfunction, etc. that may arise as a result of defective maintenance by people not employed by SDI.

  • Page 105: Limited Warranty Conditions

    Written or verbal permission must be received before any instruments are returned to SDI. SDI 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 106: Spirometry Indications

    The Spirometry Source 8.0 SPIROMETRY INDICATIONS Although the early detection of COPD is perhaps the most important indication for application of office spirometry, there are many others that have proven to be helped in the diagnosis of disease. Dyspnea (shortness of breath) Exercise-induced coughing Chest tightness Smokers over 45 years of age (NLHEP recommendation)

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