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The Spirometry Source

2
Users Manual

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 1

The Spirometry Source

Table of Contents

CAUTION: Federal law restricts this device to sale by or on the order of a physician!

TABLE OF CONTENTS
DECLARATION OF CONFORMITY ......................................... 4 SAFETY ............................................................................... 5 1. 1.1 1.2 1.3 INSTRUCTIONS FOR USE AND INSTALLATION ............ 6 INTRODUCTION .......................................................... 7 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS ............................................................. 8 INSTALLATION AND START-UP..................................... 9 CLEANING THE TURBINE ........................................... 10

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The Spirometry Source

2.0

ASTRA 200 OPERATION ............................................. 13

Table of Contents

STANDARD PARAMETERS ........................................... 14 2.1 2.2 2.3 2.4 FUNCTION TREE ........................................................ 15 EQUIPMENT CUSTOMIZATION ................................... 18 EQUIPMENT PROTECTION ......................................... 21 FORCED VITAL CAPACITY FVC TEST PROCEDURE ...................................................... 22 QC GRADES ............................................................... 44 PRINTING THE REPORT ............................................. 39 2.5 2.6 2.7 2.8 2.9 SLOW VITAL CAPACITY VC TEST PROCEDURE ...................................................... 46 MAXIMUM VOLUNTARY VENTILATION MVV TEST PROCEDURE ..................................................... 48 POST BRONCHODILATOR SPIROMETRY PROCEDURE .............................................................. 50 CALIBRATION PROCEDURE ........................................ 53 INTERNAL DATABASE ................................................ 59

2.10 MAINTENANCE PROGRAM .......................................... 63 2.11 UPDATING INTERNAL SOFTWARE .............................. 70 3.0 4.0 PERFORMING SPIROMETRY ....................................... 74 LIMITED WARRANTY CONDITIONS ............................ 76 SPIROMETRY INDICATIONS ...................................... 77

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The Spirometry Source

SPECIAL PRECAUTIONS
The ASTRA 200 spirometer has been designed for use with safety in mind. All operating instructions must be read before using the ASTRA 200. Not doing so may lead to injuries to the user or the patient and damage to equipment and/or accessories.

Safety
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INTENDED USE
The spirometer measures and calculates a series of parameters related to human respiratory function. This instrument is designed for use by medical staff and by the patient when supervised and instructed by a doctor. The spirometer is not designed for use outdoors or under other conditions or using other 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 significant patient FVC values. The doctor must assess the patients capacity to perform the spirometry test.

LIMITATIONS OF USE. CONTRAINDICATIONS


An analysis of the results of a spirometry test is not enough in itself to give a correct diagnosis of the patients clinical condition. The patients records and any tests that the doctor believes necessary must therefore also be considered. A doctor must interpret the tests to determine the course of treatment needed. The patients symptoms must be taken into account by medical staff before any spirometric test is undertaken.

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The Spirometry Source

ELECTRICAL RISKS
Dot NOT disassemble the equipment casing. The device must only be serviced and repaired by skilled personnel. The contact with voltage inside the system may cause serious injury. Do NOT use damaged accessories.

Safety

Do NOT submerge the electronic parts of the device in any liquid. To ensure vital safety features under the EN 60601-1-1 standard, only equipment compliant with the electrical safety standards in force may be connected to this device. The equipment must be stored and used within the temperature, pressure and humidity ranges specified.

RISKS OF EXPLOSION
Do NOT use the equipment in the presence of volatile anesthetics or inflammable gases.

RISKS OF CONTAMINATION
Turbine transducer: To avoid the risk of contamination or cross infection, the turbine must be disinfected before use or used with a protective barrier filter. Consult page 10, Cleaning the Turbine.

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The Spirometry Source

Instructions for Use and Installation

1. INSTRUCTIONS
FOR USE AND INSTALLATION

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The Spirometry Source

1.1 INTRODUCTION
Instructions for Use and Installation
The Astra 200 spirometer is a compact device with a high-resolution LCD display. It is designed to function with a turbine-type transducer and may be be connected to an external printer via a supplied USB cable. The entire system is controlled by a microprocessor for the acquisition, calculation and presentation of alphanumeric and graphical data.

ASTRA 200 LIST OF CONTENTS

Part No. Qty.


29-5200 29-7990 29-7966 29-5017 29-5023 29-5003 29-5021 29-5022 1 10 10 1 2 1 1 1

Description
SDI Astra 200 AstraGuard Bacterial/Viral Filters Noseclips Quick Reference Card AA 1.5 V Alkaline Battery Turbine Transducer Cable Mini USB (PC Link) Cable Mini USB(External Printer Option)

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1.2 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS


Instructions for Use and Installation

The Spirometry Source

5 2 6

7 8 9 10

123456789-

On/off button Alphanumeric LCD display Keypad Turbine transducer USB connection RS232 series connection Specifications plate Lithium battery (CR1632) Firmware loading switch 10- Main batteries (2xAA 1.5V)

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The Spirometry Source

1.3 INSTALLATION AND START-UP


Astra 200 INSTALLATION
The ASTRA 200 spirometer is CLASS IIa device 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. Batteries The Astra 200 spirometer works as standard using two AA 1.5 V batteries or optionally using rechargeable NiMH batteries (AA 1.2 V type). WARNING: Never try to recharge alkaline batteries. This would cause damage to both the batteries 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. The charging time for rechargeable NiMh batteries will depend on the charger used. To save power, the equipment includes an auto switch off system that turns the equipment off when a key has not been pressed for 5 minutes, except in main spirometry screens. In this case, the data on the screen is lost and the normal process must be followed to restart the equipment. NOTE: When inserting the batteries for the first time or when replacing them, the equipment may switch on automatically. This is normal and does not indicate malfunction.

Instructions for Use and Installation

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The Spirometry Source Atmospheric conditions The atmospheric working conditions are: Ambient temperatures between 10 and 40C. (The American Thoracic Society recommends 17 to 40C) Relative humidity below 75% (without condensation) Atmospheric pressure from 430 to 800 mmHg (from approximately 4500 to - 400 meters)

Instructions for Use and Installation

CLEANING THE TURBINE


ATTENTION: to avoid the very serious risk of crosscontamination when using turbine with plain cardboard mouthpiece, the turbine must be cleaned after every use. Alternatively, the use of one-way valve mouthpieces and/or bacterial/viral filters is strongly recommended.

Extract the turbine from the machine by pulling it and (if necessary) pushing it out gently from behind; Immerse the turbine into a cold disinfecting solution and move it inside the solution to remove any impurities contained both inside and outside the turbine tube. Let it soak for the time specified in the instructions of the solution, generally for at least 20 minutes; If directed by the manufacturer of the disinfection solution, soak the turbine in a small bowl of water for 3 minutes. Do no allow water from a running faucet to pass through the turbine. Doing so may damage the transducer. Shake the turbine to shake off the excess solution and leave it to dry on a clean surface in an upright position; When the turbine is dry or almost dry insert it into the spirometer.

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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.

Instructions for Use and Installation

HANDLING THE EQUIPMENT


The spirometer has been designed for easy operation. Although it allows a number of sophisticated functions, its design will quickly demonstrate that it is truly intuitive for any medical staff.

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The Spirometry Source

NOTES:

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The Spirometry Source

Astra 200 Operation

2.0 Astra 200 OPERATION

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The Spirometry Source

Astra 200 Parameters (Selectable)


FVC FVC - Forced Vital Capacity FEV1 - Forced Expiratory Volume in 1 second FEV1/FVC - Ratio of FEV1 to FVC FEV6 - Forced Expiratory Volume in 6 seconds FEV1/FEV6 - Ratio of FEV1 to FEV6 FEV .5 - Forced Expiratory Volume in ,5 seconds FEV3 - Forced Expiratory Volume in 3 seconds FEV.5 / FVC - Ratio of FEV.5 to FVC FEV3 / FVC - Ratio of FEV3 to FVC FEV1 / VC - Ratio of FEV1 to Slow Vital Capacity FEF25% - Maximum Expiratory Flow @ 25% of blow FEF50% - Maximum Expiratory Flow @ 50% of blow FEF75% - Maximum Expiratory Flow @ 75% of blow FEF25%-75% - Avg. Forced Expiratory Flow between 25% and 75% of blow FEF75%-85% - Avg. Forced Expiratory Flow between 75% and 85% of blow FET25%-75% - Expiratory Time between 25% and 75% of blow FET 100%- Total forced expiratory time FEF50%/FIF50% - Maximum Expiratory Flow@50%/Mean Inspiratory Flow@50% FEV1 / FEV.5 - Forced Expiratory Volume @1 sec / Forced Expiratory Volume @ .5 sec FEV1 / PEF - Forced Expiratory Volume @1 sec / Peak Expiratory Flow FIF50% - Maximum Inspiratory Flow @ 50% of blow FIVC - Forced Inspiratory Vital Capacity FIV1 -Forced Inspiratory Volume in 1 second FIV1 / FVC - Ratio of FEV1 to FVC FEV1 / FIV1 - Ratio of FEV1 to FIV1 PIF - Peak Inspiratory Flow MTT - Mean Transit Time PEF / PIF - Ratio of PEF to PIF BEV - Back-extrapolated Volume COPD Ind - COPD Index PEF - Peak Expiratory flow Lung Age MVV - Maximum Voluntary Ventilation Br/min - Breaths per minute VC - Slow Vital Capacity TV - Tidal Volume ERV - Expiratory Reserve Volume IRV - Inspiratory Reserve Volume IC - Inspiratory Capacity Ti - Inspiratory time Te - Expiratory time Tt - Total Time Ti/Tt - Ratio of Ti to Tt

Astra 200 Operation

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The Spirometry Source

2.1 FUNCTION TREE


The Astra 200 spirometer function tree is shown for a better understanding of its structure.

Astra 200 Operation

The Astra 200 has 4 silicon keys located underneath the screen to move around the different menus in the equipment. In general, the and keys enable you to move around the different menu options. The the key provides access to the selected option and key takes you back to the previous menu.

The following can be accessed from the Main Menu, depending on the options included: 1. SPIROMETRY 2. CALIBRATION 3. DATABASE 4. CUSTOMIZE 5. MAINTENANCE 6. BLUETOOTH 1.SPIROMETRY 1. FVC (Forced Vital Capacity Test) 1. Start maneuver 2. Results 3. Interpretation 4. Save DB 5. Save PRE 6. Print Report 7. Delete 8. New patient

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Astra 200 Operation

The Spirometry Source 2. VC (Slow Vital Capacity Test) 1. Start maneuver 2. Results 3. Save DB 4. Save PRE 5. Print Report 6. Delete 7. New patient 3. MVV (Maximum Voluntary Ventilation Test) 1. Start maneuver 2. Results 3. Save DB 4. Save PRE 5. Print Report 6. Delete 7. New patient 4. Bronchodilation (Post-Drug) 1. PRE maneuvers 1. Delete PRE 5. Total Report 6. New Patient 2. CALIBRATION 1. Check Calibration 2. Calibration 3. Calibration DB 1. Register Data 2. Delete Register 3. Print Report 3. DATABASE 1. Explore DB 2. Search patient 3. Search register 4. Summarized report 5. Delete DB

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The Spirometry Source 4. CUSTOMIZATION 1. Spirometry 1. Predicteds 1. Adults 2. Children 3. Ethnic Factor 2. Parameters 1. FVC 2. VC 3. MVV 3. Graphs 4. Interpretation 5. Post BD Mode 6. Alerts 2. Printers 3. Standard 1. Load standard 2. Modify standard 5. Battery 6. Language 7. Set clock 8. PIN 5. MAINTENANCE 1. Select Alerts 2. LCD contrast 3. Equipment check 1. Ext.Printer 2. ADCs 3. LCD 4. CPU 5. Auto On/Off

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Astra 200 Operation

The Spirometry Source 4. Equipment config. 1. Reset 2. Reindex 3. VC Mode 4. Updt. Key

Astra 200 Operation

5. Standard curves 1. FVC 2. VC 3. MVV 6. Bluetooth

2.2 EQUIPMENT CUSTOMIZATION


Every user should customize the Astra 200 spirometer according to his requirements due to the multiple variety of options included. The different options included in the Customization menu are explained in detail in the previous section.

SPIROMETRY CUSTOMIZATION
This option customizes any suboptions specific to the spirometric tests 1. Predicteds The predicted set required can be selected (SEPAR, ERS, KNUDSON, CRAPO, ZAPLETAL, MORRIS, AUSTRIACAS, GUTIERREZ-CHILE, BRAZIL, POLGAR, P.PADILLA-MEXICO, NHANES III, and others) for adults and children and includes an optional ethnic correction. The NHANES III predicted set allows the choice of three different ethnicities-Caucasian, Afro-American or Hispanic.

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The Spirometry Source It prioritizes the age range selected for adults if a different table is chosen for children and extrapolates the values for the ages outside the table range selected. 2. Parameters The observed or measured parameters to be calculated and reported are selectable. This is only at display level or for the report. All the parameters are saved to the database and can be enabled at any time. 3. Graphics The graphics can be saved to the database. 4. Interpretation One of four different interpretation modes can be selected. These are Miller, Kory/ Lyons, NLHEP or ATS. 5. Bronchodilation modes One of several comparison modes can be selected for the POST-Drug function. 6. Warnings The printing of Non-conformity warnings regarding the operations with ATS/ERS criteria can be selected.

Astra 200 Operation

PRINTER CUSTOMIZATION
In this option you can choose if you want to print in black and white or color. The Astra 200 interfaces only with HPPCL printers. To be able to print from the equipment you must:

Select the type of printer connected to the equipment (once this has been done you will not have to repeat this step unless the printer is changed).

Connect the equipment to the external printer using the Mini USB cable included with your Astra 200 spirometer 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 19

The Spirometry Source

Switch the printer on.

STANDARD CONFIGURATION
Astra 200 Operation
20 This option memorizes a user-defined customization program status to retrieve it at any time globally and automatically. This option restores the original customization if it has been modified either voluntarily or by accident. In general, this configuration will correspond to that most often used. 1. Retrieve Standard The configuration saved can be loaded as standard. 2. Modify Standard The configuration to date can be saved for use as standard.

BATTERY CUSTOMIZATION
The Astra 200 works with two types of battery (alkaline or NiMh), independent to the battery selected in this section. This selection only affects the calculation made inside the equipment to indicate the battery levels.

LANGUAGE CUSTOMIZATION
This option allows for the equipment language to be chosen.

SET CLOCK
This option sets the time and the date of the internal clock

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 screens will appear successively:

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The Spirometry Source CHANGE PIN Current Pin: 0000 CHANGE PIN Pin Enabled: Yes CHANGE PIN New(1): 0000 CHANGE PIN New(2): 0000 To enable protection, select YES on the Pin Enabled screen and enter the PIN in the New(1) and (2) screens. To change the PIN, you must enter the current one. If an erroneous PIN is entered three times, the equipment will lock and will switch off. See the following section (2.3 EQUIPMENT PROTECTION).

Astra 200 Operation

2.3 EQUIPMENT PROTECTION


If equipment protection has been enabled, the following screen will appear when it is started: ENTER PIN Pin: 0000 If the PIN configured in Equipment protection customization is entered, access will be given to the Astra 200 and the main screen will appear. If an invalid PIN is entered three times, the equipment will lock and will switch off. The following screen will appear when it is restarted:

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The Spirometry Source

UNLOCK CODE 00000000000000

Astra 200 Operation

Enter the unlock code (PUK) supplied on purchasing the equipment. If the correct code is entered, the Astra 200 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 erroneous code is entered, the equipment will remain locked. This prevents access to the equipment and, more specifically, to the private data it contains by unauthorized people.

2.4 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.

ENTERING PATIENT PARAMETERS


Start the Astra 200 using the following screen to appear: MAIN MENU 1 Spirometry key and wait for the

Press the

key and the following will appear:

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The Spirometry Source SPIROMETRY 1 FVC

Press the

key and the following will appear: PATIENT DETAILS Code: 0000000000

Astra 200 Operation

Enter the patient code (between 0 and 9999999999). Select the digit space using the or Press the or keys and

to set the value for each digit. key to confirm and go to the next digit

until the ID number is completed. PATIENT DETAILS Age (years): xx PATIENT DETAILS Height (in): xxx PATIENT DETAILS Weight (Lb): xx

Between 4 and 100

Between 20 and 90 inches

Between 33 and 441 pounds

PATIENT DETAILS Sex: Male

Between male and female

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The Spirometry Source PATIENT DETAILS I. Smoker: xx PATIENT DETAILS Cig/day: xx PATIENT DETAILS Ethnic F.: xxx Between 0 and 200 packs a day times number of cigarettes Between 0 and 20

Astra 200 Operation

Between 80 and 120%

The Smoker Index is the same as the number of cigarettes smoked a day divided by 20 and multiplied by the number of years smoking (cigarettes day x years smoking / 20). The ethnic factor is used in areas without any parameters of reference that use some existing yet corrected in a certain percentage. This factor MUST BE SET TO 100 IF NOT USED and can only be modified through the Customization Program. Press the Use the key to go to the FVC TEST screen. or keys to select

one of the following options: FVC TEST 1 Start Manuver Allows for spirometric maneuvers to be acquired FVC TEST 2 Results Displays the results of the best three maneuvers FVC TEST 3. Interpretation Displays the diagnosis according to the results obtained 24 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source

FVC TEST 4 Save DB

Saves the selected maneuver to the Database

Astra 200 Operation

FVC TEST 5 Save PRE

Saves in the Database as PRE FVC TEST 6. Print Report

Prints the report on any completed maneuver FVC TEST 7 Delete

Deletes any maneuver FVC TEST 8 New Patient

Option to change patient or to change some datails of an existing patient ENTERING FORCED VITAL CAPACITY FVC TESTS To carry out the forced spirometry tests, the technician must know the normal procedures required so that the patient can be coached. Where this is not the case, certain documentation on the matter must be reviewed. When doing spirometry testing, be sure to take the following steps: 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 25

The Spirometry Source

1 Check that the turbine is correctly installed and the AstraGuard filter is correctly inserted, as in the figure:
Astra 200 Operation
INSERT FIRMLY

2 Instruct the patient as to how to carry out the test, as his cooperation is vital for it to be completed correctly. Patients can carry out the spirometry maneuvers in two different ways:
The first method consists of a patient inhaling to TLC, followed by a FORCED EXPIRATION followed by FORCED INSPIRATION (if the inspiratory data is required). The second method consists of the patient breathing tidally through the turbine and, when directed by the technician, filling his lungs to TLC followed by a FORCED EXPIRATION which may be followed by a forced inspiration, if inspiratory data is required.

3 Instruct the patient in the proper way tohold the spirometer, taking care not to press any key and fitting the nose clip as shown in the following figure.

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The Spirometry Source

4
the

Select the screen

1 Start Maneuv.

and press

key. The following screen will appear:

Astra 200 Operation

MEASURING The equipment is held so that the technician can see the screen while the patient is carrying out the tests. On the left-hand side is a rectangle indicating that the equipment is ready for the test to be started. The patient has 30 seconds to begin. After this time, if he has not started, the equipment will switch to standby and must be reactivated. After the expiratory maneuver, the second line of the screen will show a bar, movement of which is proportional to the volume of the expiratory maneuver. The maximum value of the bar corresponds to a volume of 6 liters. At the end of the maneuver, one or more of the warnings, if enabled in the Customization Program, may appear toalertthat the maneuver is not in compliance with ATS/ERS Criteria. An indication is given to inform you that the maneuver has not been carried out according to one of the following ATS/ ERS criteria: ET - Indicates that expiratory manuver has not completed satisfactorily, as the variation on volume in the last second of the maneuver was above 25 ml, or the maneuver has lasted less than 6 seconds (in patients aged over 10 and more) or less than 3 seconds (in patients aged 10 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 litres. The ATS/ERS recommends it be less than 5% of the FVC or 0.15 liters, whichever is higher. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

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The Spirometry Source The technician performing the spirometry testing may, where considered appropriate, disable these warnings in the Customization Program. In this case, they will also be removed from the printed report.

Astra 200 Operation

This disabling is only at display level. The warnings are still considered when listing the maneuver sequence.

Press the

key if the alerts are enabled.

If you have chosen the NHANES predicted set and the NLHEP Interpretation program, the following alerts may appear: QUALITY CONTROL: If Back extrapolated volume (BEV) Dont Hesitate >150 mL QUALITY CONTROL: If expiratory time (FET) <6.0 sec & Blow Out Longer EOTV (End-of-test volume) >40mL QUALITY CONTROL: Blast Out Harder QUALITY CONTROL: Deeper Breath QUALITY CONTROL Blast Out Faster If Peak expiratory flow (PEF) >1.0L/sec If FEV6 match>150mL

If Peak expiratory flow time (PEFT) >120 msec

After the alerts are displayed, the following screen or similar will be shown, depending on the parameters selected in the Customization Program. FVC X.XX YY% FEV1: x.xx yy% 28 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source X.XX: Actual Value of the parameter, in this case FVC. YY: % between the Observed value and the value of Reference. x.xx: Actual Value of the parameter, in this case FEV1. yy: % between the Observed value and the value of Reference. ATTENTION: Check in the Customization Program that the Predicteds and/or the Ethnic Factor are suitably selected. The Ethnic Factor modifies the value of the Predicteds according to the percentage selected. 100% is equivalent to the unmodified standard value of the Predicteds. Using the selection keys or it is possible to

Astra 200 Operation

view the observed value and the percentage in relation to the value of reference for each customised parameter. If a parameter does not have a Predicted Value, the corresponding percentage will not appear.

Press the key again and complete a new maneuver. As many maneuvers as required can be completed. The Astra 200 will always save the five best FVC and VC and the three best MVV maneuvers according to ATS/ERS criteria (*). No more than eight maneuvers should be attempted to avoid tiring the patient. If three or more maneuvers have been completed and the FVC and/or FEV1 parameters are flashing, this indicates that the repeatability criteria for one or both parameters has been met. These criteria indicate that the best two observed values of FVC and the best two of FEV1 differ in no more than 120 ml if the FVC is greater than 1 liter or in no more than 100 ml if the FVC is less than or equal to one liter. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 29

The Spirometry Source NOTE: Remember that the back key takes you back in the menu without losing the current data, except where you enter a new patient or select a previous patient from the database.

Astra 200 Operation

(*) ATS/ERS criteria: The maneuver with least number of warnings is considered the best (ET, EX). With the same number of warnings, the maneuver with the highest sum of FVC+FEV1 is considered the best.

DISPLAYING RESULTS
The results can be seen once at least one maneuver has been completed. To do so, go back to the following screen FVC TEST 1 Start Maneuv. and, using the or keys, select the option

FVC TEST 2 Results Press the will appear: key and a similar screen to the following RESULTS M1 M2 [M3] M4 M5 Indicates the number of maneuvers in the memory. The best (M1) will always be selected (flashing text) by default.

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The Spirometry Source This screen indicates the following: Number of maneuvers in memory. There may be from one to five maneuvers. The maneuvers are sequenced according to ATS/ERS criteria (*) explained in the previous section, with M1 the best and M5 the worst. The maneuver between brackets [M3] indicates the position taken by the last maneuver entered. The flashing text indicates the maneuver selected. . or

Astra 200 Operation

To display the results, press

To select another maneuver, press the keys

Therefore, the brackets [ ] and the flashing text do not have to match. On accessing the results of a test, the best FVC (mFVC) and the best FEV1(mFEV1) will appear first, followed by the results of the selected maneuver. The best FVC and FEV1 values may correspond to any of the available maneuvers.

INTERPRETATIONS
The Astra 200 spirometer has several interpretation schema that can be selected in the Customization Program. NOTE: If you do not agree with these criteria, do not use them as a reference for diagnosis. The interpretation and the results of the test must always be validated by the clinician. Miller Interpretation This presents the following information: NORMAL, RESTRICTIVE, OBSTRUCTIVE or COMBINED, according to the 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 31

The Spirometry Source criteria in the following chart:

Astra 200 Operation


Snider, Kory & Lyons Interpretation 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 and FEV1 < 80% of the FEV1 Reference Obstructive ventilatory disturbance FEV1 < 80% Slight FEV1 < 65% Moderate 32 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source FEV1 < 50% Intense FEV1 < 35% Very Intense If FEV1/FVC% < FEV1/FVC% Reference and FVC < 80% of the FVC Reference Non-obstructive ventilatory disturbance FVC < 80% Slight FVC < 65% Moderate FVC < 50% Intense 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 exceeds the base FEV1 or PRE by 15%, there is a positive response to the bronchodilator

Astra 200 Operation

The ATS/ERS and the Ferguson interpretations are outlined in the following illustrations:

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The Spirometry Source

Astra 200 Operation


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The Spirometry Source

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Astra 200 Operation

The Spirometry Source

Astra 200 Operation


Repeatabilty In keeping with ATS/ERS guidelines, the Astra 200 will alert you of test repatability for FVC and FEV1 when two tests match within <150mL of each other unless the FVC is less than 1 Liter; then it is <100mL. If repeatability occurs, the following screen will be displayed REPEATABILITY FVC:Yes FEV1:Yes 36 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source

QC GRADES
Quality Control grades will be assigned according to the following guideline A = At least 2 acceptable maneuvers with the largest two FEV1 values matching within 100 mL and the largest 2 FEV6 values matching better than 100 mL B = At least 2 acceptable maneuvers with FEV1 values matching matching between 101 and 150 mL C = At least 2 acceptable maneuvers with FEV1 values matching between 151 and 200 mL D = Only one acceptable maneuver, or more than one, but the FEV1 values match >200mL (no interpretation) F= No acceptable maneuvers (no interpretation)

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Astra 200 Operation

The Spirometry Source

SAVING FVC TESTS


Saving a test in the Internal Database

Astra 200 Operation

The Astra 200 spirometer has an Internal Database that can save different tests to be subsequently transferred to a PC Database using AstraPro Spirometry Software. This base may be of the L or H, depending on its capacity. The process is similar to that described in the DISPLAYING RESULTS section, although previously selecting the option FVC TEST 4 Save DB Press the key and a similar screen to the following

will appear, depending on the number of maneuvers made: SAVE DB M1 M2 [M3] M4 M5 The maneuvers are sequenced according to ATS/ERS criteria (*), with M1 the best and M5 the worst. The maneuver between brackets [M3] indicates the position taken by the last maneuver entered. The flashing text indicates the maneuver selected (the best [M1] is selected by default) Select the maneuver to be saved using the keys and 38 (appearing between brackets) and press 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com .

The Spirometry Source The following screen will appear for a few seconds: MANEUVER N.: X SAVED

Astra 200 Operation

If you have made a mistake or wish to modify the maneuver, repeat the process. (*) ATS/ERS criteria: The maneuver with least warnings is considered the best (ET, EX). With the same number of warnings, the maneuver with the highest sum of FVC+FEV1 is considered the best.

Saving a PRE bronchodilator test for a comparison to a POST bronchodilator test This option allows for a test to be saved in PRE bronchodilator mode which can be recalled at a later time to then compare it with a test made in the POST bronchodilator (Post-Drug) mode. The process is similar to that described above.Using the and keys, select FVC TEST 5 Save PRE Press the key and a similar screen to the

following will appear, depending on the number of maneuvers Check that the printer is ready and connected. Select 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 39

The Spirometry Source SAVE PRE M1 M2 [M3] M4 M5

Astra 200 Operation

Select the maneuver to be saved using the keys and . (appearing between brackets)and press .

The following screen will appear for a few seconds: MANEUVER PRE N.: X SAVED If you have made a mistake or wish to modify the maneuver, repeat the process.

QC GRADES
Quality Control grades will be assigned according to the following guideline A = At least 2 acceptable maneuvers with the largest two FEV1 values matching within 100 mL and the largest 2 FEV6 values matching better than 100 mL B = At least 2 acceptable maneuvers with FEV1 values matching matching between 101 and 150 mL C = At least 2 acceptable maneuvers with FEV1 values matching between 151 and 200 mL D = Only one acceptable maneuver, or more than one, but the FEV1 values match >200mL (no interpretation) F= No acceptable maneuvers (no interpretation) 40 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source

PRINTING THE REPORT


The Astra 200 spirometer can print any maneuver made using an external printer. The process is similar to that described in the previous section, but previously selecting the option FVC TEST 6 Report Press the key and the following screen will appear: REPORT [M1] M2

Astra 200 Operation

the maneuver to print (flashing text) and press best (M1) is recommended.

. The

The printer will present a report similar to the one on the following page: This will include the parameters and graphs corresponding to the selected curve. If you do not want graphs, certain parameters, interpretation and/or ATS/ERS warnings to appear, disable them as described in Section 2.2. EQUIPMENT CUSTOMIZATION. PLEASE NOTE: THE BEST MANEUVER CORRESPONDS TO THE ONE SAVED IN POSITION M1 AND WILL BE SELECTED BY DEFAULT. If you want a global printout of the report, including the FVC, VC and MVV tests made on a patient, follow the steps described in the General Report Printing Section. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 41

The Spirometry Source The following screen will appear during the printing process: PRINTING

Astra 200 Operation

The top line indicates the percentage of the report produced. Printing can be cancelled at any time by pressing the key .

42

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The Spirometry Source

DELETING A MANEUVER
The Astra 200 spirometer deletes any maneuver. The process is similar to that described in the previous section, but previously selecting the option:

Astra 200 Operation

FVC TEST 7 Delete

Press the will appear:

key and a similar screen to the following DELETE [M1] M2

Using the

or

key, select the maneuver to

delete (flashing) and press The following screen will appear: WANT TO DELETE THE MANEUVER? Press the key to cancel and not delete the maneuver. key to delete the maneuver, the

If you press the

following screen will appear: MANEUVER N.: X DELETED

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The Spirometry Source

OTHER TESTS ON THE SAME PATIENT


After carrying out the FVC test on a patient, the following testing functions are available

Astra 200 Operation

A VC 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 Start the test process on another patient.

The spirometer saves the best maneuver of each FVC, VC, MVV and/or Bronchodilation test to print a general report containing, if desired, all tests before going on to another patient. From the next screen and using keys any of the first four options. or select

CHANGE PATIENT
This option is used to enter a new patient or to change some details of an existing patient. The process is similar to that described in the previous section, but previously selecting the option: FVC TEST 8 New patient Press the key and the following screen will appear: PATIENT DETAILS Code: 0000000000

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The Spirometry Source Enter the patient code required (between 0000000000 and 9999999999). If you wish to modify some details of an existing file, enter the appropriate ID code.

Astra 200 Operation

Follow the procedure designed in the ENTERING PATIENT PARAMETERS procedure to enter the details of a new patient or to modify the details of an existing patient. If you have not saved the tests completed to date, the following warning will appear after the last screen of data: DELETE UNSAVED TESTS? YES> NO<

If you press database.

, the tests completed will be saved in the

If you press , the tests completed will not be saved in the database and CANNOT BE RECOVERED. All the tests completed will then belong to the new patient. NOTE: If details of an existing patient have been modified, the parameters will be recalculated reflecting the changes made.

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The Spirometry Source

2.5 SLOW VITAL CAPACITY (VC) TEST PROCEDURE


The procedure to carry out the slow Vital Capacity (VC) test is similar to that described in Section 2.4 FORCED VITAL CAPACITY (FVC) PROCEDURE with the following variations:

Astra 200 Operation

1 If the test is carried out on the same patient, as described in the OTHER TESTS ON THE SAME PATIENT section,
go back using the key to the Test Selection or , the VC

window and select, using keys test. SPIROMETRY 2 VC

If the patient is new, begin as described in the ENTERING PATIENT PARAMETERS section.

2 In order for the test to produce meaningful results, the patient must be carefully instructed on how to perform the test. 3 The maximum time allowed for the maneuver is 45 seconds. The spirometer will evaluate all tests and save the values from the best test. 4 To measure the ERV and TV parameters correctly, each maneuver must have at least four inspire:expire cycles. 5 The tabular and graphical report is as shown on the following.
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The Spirometry Source

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Astra 200 Operation

The Spirometry Source

2.6 MAXIMUM VOLUNTARY VENTILATION (MVV) TEST PROCEDURE


Astra 200 Operation
The procedure to carry out the Maximum Voluntary Ventilation (MVV) test is similar to that described in Section 2.4 FORCED VITAL CAPACITY (FVC) PROCEDURE with the following: If the test is carried out on the same patient, as described in the OTHER TESTS ON THE SAME PATIENT section, go back using the key to the Test Selection or , the MVV

window and select, using keys test. SPIROMETRY 3 MVV

If the patient is new, begin as described in the ENTERING PATIENT PARAMETERS section.

Instruct the patient as to how to carry out this type of test, as his cooperation is vital for it to be completed correctly.

The maximum time allowed for the maneuver is 15 seconds. The Astra saves the best MVV based on all maneuvers

4 The register of parameters and graphics is as shown on the following page.

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The Spirometry Source

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Astra 200 Operation

The Spirometry Source

2.7 POST BRONCHODILATOR SPIROMETRY PROCEDURE


Astra 200 Operation
The Astra 200 spirometer allows for Post bronchodilator tests to be carried out in FVC, VC and MVV provided a test has previously be completed in PRE bronchodilator mode and saved to the database. The purpose of this operating mode is to provide reporting PRE and POST spirometric results after administration of a bronchodilator. The procedure to carry out Post bronchodilator Spirometry is as follows:

Complete a FVC, VC or MVV test on the patient before administering the bronchodilator, as described in the previous sections. Save the PRE test in the database to compare it in POST mode, as explained in SAVING FVC TESTS in Section 2.4.

Administer to the patient the appropriate dosage of bronchodilator as prescribed by the clinician and wait for the prescribed period.

Go back using the

key to the Test Selection or ,

window and select, using keys SPIROMETRY 4 Post-Drug Press the

key to select the screen: POST-DRUG 1 PRE maneuvers

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The Spirometry Source Press .

The tests saved in PRE mode will then be displayed.

Astra 200 Operation

Select the PRE test with which it is to be compared and

press

Proceed as indicated in Section 2.4 FVC TEST PROCEDURE. The only variation is in point 5, as the % is weighted in relation to the observed values in Pre bronchial and Post bronchial mode. If the printed report is requested, the data is presented as shown below. Three columns of data can be seen: PRE (PRE bronchodilator Observed Values) POST (POST bronchodilator Observed Values) %WGT (% weighted between the POST and PRE values)

%WGT = 100 x 2 (POST-PRE) / (POST+PRE) (See J.E. Cotes: Lung Function. Assessment and Application in Medicine. Blackwell Sci. 4th Edition 1979, p52-53)

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The Spirometry Source

Astra 200 Operation


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The Spirometry Source

2.8 CALIBRATION PROCEDURE


GENERAL OBSERVATIONS
For the most part, the Astra turbine, because of its mechanical design, needs calibrating infrequently. It is impervious to changes in pressure, gas viscosity and moisture. The Company understands, however that there exist protocols that call for daily calibration. ATS guidelines call for a daily Calibration Check. This assures that the calibration of the device is within factory specifications. The Calibration Check function in your Astra spirometer is a quick and easy way of assuring you that your spirometer is accurate. Generally accepted practice in spirometry recommends that all spirometers be perfectly calibrated. This is due to the alterations that may modify the characteristics of the electronic circuits and mechanical parts over time and cause a change in the spirometer calibration factors. Hence, a calibration system has been incorporated based on a volume signal of reference (e.g. a syringe). Furthermore, this calibration factor must take into account the changes in volume associated to atmospheric conditions. The most influential factor is temperature. The Astra 200 includes a Calibration Program for fast (less than one minute) and easy checking and auto-correcting of diversion in the measurements taken based on a standard or reference volume for the quality control of the different spirometric tests.The regularity of calibration depends on the user.

Astra 200 Operation

CALIBRATION PROCESS

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The Spirometry Source The calibration process is as follows:

Install the spirometer and the syringe as in the following:

Astra 200 Operation

Power up the Astra 200 using the for the following screen to appear: MAIN MENU 1 Spirometry

key and wait

With the keys

or

select:

MAIN MENU 2 Calibration

Press

, the following screen will appear: CALIBRATION 1 Calibration

Press

and enter the volume of the syringe in

liters (between 0 and 6 liters, depending on the syringe) CAL. DATA Volume (l): x If a 0 is entered, the default factors are used (Fct = 1 and 54 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source NPulses = 200) and the calibration process is completed. NOTE: Where no syringe is available, the value entered in Volume is not relevant and is not taken into account when automatically calibrating the equipment.

Astra 200 Operation

Press

. The following screen will appear:

CAL. DATA No. Pulses: xxx If the number of pulses associated with its turbine is as appears on screen, continue without modifying it. If it is different, enter the number of turbine pulses. In this case, the factors are calculated and the calibration process completed. NOTE: Each turbine is factory calibrated individually and is associated to a factor equivalent to the pulses/liter detected (etched on the turbine body). Although variability between turbines is within 3%, to obtain the maximum measurement precision, it is worthwhile to enter this factor in the spirometer if the turbine is changed. Where no syringe is available, it is very important to enter the No. of Pulses of the turbine so that the equipment can be automatically calibrated.

Press

. The ambient temperature (C) detected

is based on the reading of an internal thermistor. This reading can be modified if required. CAL. DATA Temp (C): xx 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 55

The Spirometry Source

Press

. The relative humidity (%) entered in

the last calibration will appear. This can be modified if required.

Astra 200 Operation

CAL. DATA Humidity (%): xx

Press entered in

. The atmospheric pressure (mmHg)

the last calibration will appear. This can be modified if required. CAL. DATA Pres(mmHg): xxx

10 Press

, the following screen will appear:

CALIBRATION Start Calibra.

11 Press

again and start emptying the syringe for

two or more consecutive cycles (one cycle is equal to emptying and filling the syringe). When emptying and filling the syringe piston must move all the volume used as a reference. If this is not done correctly, the equipment will detect it as incorrect maneuvers. Furthermore, this process should be completed in a regular and uniform manner, without causing flow rates that are too high or too low. Where this is not the case, you will be told to repeat the maneuver. 56 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source The time of each cycle (emptying plus filling the syringe) must be no less than four seconds and no more than ten seconds. The equipment waits for 30 seconds for calibration to begin. The process must be restarted if this time is exceeded. During calibration, the second line of the screen will show a bar, movement of which is proportional to the volume applied. On completion, the following screen will appear if the procedure was accepted:

Astra 200 Operation

CALIBRATED! Ve = Vi = 3.00 l< 2%

Calibrated volumes

12 Once thespirometer has been calibrated, press


and the screen will return to the Start Calibration option

CALIBRATION CHECK

1 Set up the spirometer and the syringe as in the Calibration 2


Power up the Astra 200 using the wait for the following screen to appear: MAIN MENU 1 Spirometry button and

With the keys

or

select:

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The Spirometry Source

4
Astra 200 Operation

Press

, the following screen will appear: CALIBRATION 1 Check Calibra.

Press

and the following screen will appear

CALIBRATION Start Cal Check

Press syringe

again and start emptying and filling the

If the Cal Check is successful, the following will appear: CHECK PASSED! Mean F.(l/sec) = XX If the Cal Check is unsuccessful, the Astra 200 will alert you with the message: ERROR!! Dif >1%. DO CAL Follow the Calibration procedure described on page 62

CALIBRATION REGISTER
The spirometer has a register containing the expiratory and inspiratory factors of the last ten calibrations or calibration checks performed. This is extremely useful for centers requiring a quality control of the processes and protocols 58

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The Spirometry Source To access this register, select the option: CALIBRATION 2 Calibration DB

Astra 200 Operation

Press

and using keys

or

access

the option required: CALIBRATION DB 1 Reg. Data

Displays the data on the last ten calibrations CALIBRATION DB 2 Delete Reg.

Deletes the data on the calibrations saved CALIBRATION DB 3 Print Report

Prints the calibration register

2.9 INTERNAL DATABASE


The Astra 200 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.

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The Spirometry Source 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

Astra 200 Operation

The saving of the tests has already been described in the sections corresponding to each test. The database always saves all the spirometric parameters of each of the different test modalities, FVC, VC, MVV or Post-Drug, despite them not being selected in the Customization program. Different functions are possible from the spirometer:

1 2 3 4 5

Search the database Search for a patient Search for a register Print a summarized report Delete the database

To access the above selections, turn on the Astra 200 using the appear: key and wait for the following screen to MAIN MENU 1 Spirometry Using the or keys, select the option:

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Pat. Code Test 2 Diagnosis 1-800-678-5782 1-508-238-7033 Pat. www.sdidiagnostics.com Code Test

The Spirometry Source MAIN MENU 3 Database

Press the key

and with

or

Astra 200 Operation

select the required function.

DATABASE SEARCH
The Astra 200 displays the parameters saved in the database for each test. If this is to be carried out on a regular basis, use the AstraPro Spirometry Software to conveniently view all the saved parameters.

Select the option: DATABASE 1 Search DB to display the results of the tests saved in the database, consult the diagnosis of each one (if the option is enabled), print a report or delete a test from the database. Press the key the option required: Pat. Code Test 1 Results Pat. Code Test 2 Diagnosis 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 61 and with or select

The Spirometry Source Pat. Code Test 3 Report Pat. Code Test 4 Delete test

Astra 200 Operation

PATIENT SEARCH
Select the option: DATABASE 2 Search Pat. to search for a patient in the database. Press the key and enter the patient code.

REGISTER SEARCH
Select the option: DATABASE 3 Search Reg. to search for a register in the database. Press the key and enter the register number.

SUMMARIZED REPORT
Select the option: DATABASE 4 Summ. Report 62

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The Spirometry Source To delete the entire database Press the key .

2.10 MAINTENANCE PROGRAM


The equipment has a maintenance program to adjust and/or check the working order of certain options. From the Main screen, press keys to choose: MAIN MENU 5 Maintenance or

Astra 200 Operation

Press the key

to access the Maintenance options.

Using keys

and

, you can move around the

different options to:

1 2 3 4 5

Configure the calibration and/or maintenance warnings Adjust the screen contrast Auto-check the equipment Configure the equipment Check with pre-saved standard curves

WARNINGS

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The Spirometry Source Select the option: MAINTENANCE 1 Select Alerts

Astra 200 Operation

This option indicates the tests completed and allows for the periods in days between calibrations or between preventive maintenance work on the equipment to be defined. If the days specified without calibration or maintenance are exceeded, the equipment warns of such by displaying a sign every time it is started. If 0 days is entered, a warning is never given. Press and the next screen will appear to enter the

calibration period. Calibration Period: x

Press

and the next screen will appear to enter the

maintenance period. Maintenance Period: xxx

Press

and an information screen will appear with the

date of the last maintenance work.

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The Spirometry Source Press again and an information screen will appear

with the total number of tests completed.

Astra 200 Operation

Press

a third time and an information screen will

appear with the number of tests completed since the last maintenance work.

LCD CONTRAST
Select the option: Using keys MAINTENANCE 2 LCD contrast and , this option enables you to

configure the screen contrast.

EQUIPMENT CHECK
Select the option: MAINTENANCE 3 Equip. Check This option allows for different parts of the equipment to be checked. Using keys and select:

EQUIPMENT CHECK 1 Ext. Printer 65

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The Spirometry Source to check the external printer selected. The SIBELMED logo will be printed along with the heading lines and 10 lines of characters. EQUIPMENT CHECK 2 ADCs

Astra 200 Operation

to see the values of the following variables: No. Pulses: 0150 Turbine Fact: 200 Alk. B.:OK +4V:OK Li B :OK 26C

EQUIPMENT CHECK 3 LCD

To test the LCD using a: - Bar test: a bar is drawn alternately on the top and bottom line of the LCD. - Contrast scan

EQUIPMENT CHECK 4 CPU

to check the CPU:

1 Calculates the flash checksum. The top line indicates the current direction and the bottom line the checksum.
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The Spirometry Source 0x300000 Chk Flash:0x59D9

Calculates the bios checksum.

Astra 200 Operation

0x20000 Chk Bios :0xBA47

Tests the internal RAM: successively writing and reading the value 0x55 in the internal RAM. The top line indicates the current direction and the bottom line the number of errors in the write/read process. 0xFFEF00 Err CPU Ram: 0

Tests the external RAM: the same process as for the internal RAM. 0x81E000 Err Ext Ram:0

EQUIPMENT CHECK 5 Auto On/Off

to check that the automatic on and off of the equipment works properly. On selecting this option, the equipment switches off and on automatically after 5 seconds.

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The Spirometry Source

EQUIPMENT CONFIGURATION
Select the option:

Astra 200 Operation

MAINTENANCE 4 Config. Equip.

This option allows for different options of the equipment to be configured. Using keys and select:

CONFIG. EQUIP. 1 Reset

to reset all equipment variables.

CONFIG. EQUIP. 2 Reindex

to reindex the database.

CONFIG. EQUIP. 3 Calibration

to enter the turbine pulses.

CONFIG. EQUIP. 4 VC mode

to choose the presentation mode for the VC curve (Normal : expiration upwards / Inverted: expiration downwards). 68 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com

The Spirometry Source

CONFIG. EQUIP. 5 Update Key

to consult the updating key for the program in Flash.

Astra 200 Operation

ATS CURVES
Select the option: MAINTENANCE 5 Standard Curves

This option checks the correct working order of the equipment using pre-saved curves. Using keys and select:

STANDARD CURVES 1 FVC

STANDARD CURVES 2 VC STANDARD CURVES 3 MVV

Select the option and following the instructions on the screen, which are similar to the FVC, VC and MVV procedures. With these curves you can operate the equipment as if they were real patient curves, with slight exceptions. 1-800-678-5782 1-508-238-7033 www.sdidiagnostics.com 69

2.11 UPDATING INTERNAL SOFTWARE


The Astra 200 spirometer has two types of internal software:

The Spirometry Source

Astra 200 Operation

BIOS (basic hardware control program) Flash (program containing all the equipment options)

The update option allows for the version of BIOS and/or Flash to be updated without having to send the equipment to the factory and without having to open it. WARNING Both updates are completed through the series port (RS232)

BIOS UPDATE
The updating process for the BIOS program is as follows:

Run the AstraPro Spirometry Software and access the Configuration - Hardware Test option. Run a communications test to check that the connections are correct. Switch the equipment off.

2 3

With the Astra 200 switched off, remove the rear cover, disconnect the Bluetooth module (where applicable) and turn both switches ON. WARNING This option should be carried out by qualified personnel.

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The Spirometry Source

4 5 6 7

Turn the equipment and support it on the table with the screen visible. Press the key for 1 second and release. Nothing will appear on the screen. Copy the BIOS file (DMBios.tsk) into the \FIRMWARE directory of the application (AstraPro). Run the AstraPro Spirometry Software, access the Configuration - Links option and check that the Astra 200 is selected.

Astra 200 Operation

8 9

Access the Configuration - Utilities - Update BIOS option.

Follow the instructions on screen and wait for the process to end.

10 Once completed, turn both updating switches OFF again,


reconnect the Bluetooth module (where applicable) and close the cover.

FLASH UPDATE
Flash can be updated for a new version of the program (in which improvements have been included) or to add another module to the equipment (Bluetooth). In the case of the latter, SDI will provide a new update key. In case of the former, consult the key in the equipment before starting the update process: Switch the Astra 200 on and select the following from the main menu MAIN MENU 5 Maintenance

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The Spirometry Source Access the option MAINTENANCE 4 Config. Equip.

Astra 200 Operation

and consult the update key in CONFIG. EQUIP. 5 Update Key Turn off the Astra 200. The updating process is as follows:

1 Run the AstraPro Spirometry Software and access the Configuration - Hardware Test option. Run a communications test to check that the connections are correct. 2 3 4
Switch off the Astra 200.

Start the Astra 200 while keeping the key depressed. This will run the program BIOS to update FLASH. The BIOS access key is then requested and then ) to prevent any user from

(Press

being able to access by mistake. Copy the new file provided by SDI containing the update (DMFlash.tsk) to the \FIRMWARE directory of the application (AstraPro).

Run the AstraPro Spirometry Software, access the Configuration - Links option and check that the Astra 200 is selected.

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The Spirometry Source

7 Access the Configuration - Utilities - Update Flash option A dialog box will open where the update key ( provided by SDI if it is an option update) must be entered. 8 The new program will be transmitted. The process may take up to 10 minutes, depending on the PC. 9
Switch off the Astra 200.

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Astra 200 Operation

3.0

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. Make note as to whether the patient is seated or standing, because subsequent testing of that patient should be performed from that same position. If the patient is standing, have a chair behind him in the event that he becomes lightheaded after the blow. It is generally a good idea to have the elderly seated for spirometry testing. If the patient is wearing a shirt or blouse with a tight-fitting collar, have him unbutton the top button and if wearing a tie, it should be loosened. If wearing dentures that are loose, it may be necessary to have the patient 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 patients apprehensive. Point out that they will be taking a slow maximal inhalation followed by a maximal exhalation, but that the exhalation will be blasting out the breath as fast as they can and as hard as they can. Key them that you will be coaching them to continue to blow out for a minimum of six seconds. Assure them that it is quite normal to blow out for that period of time. The American Thoracic Society in their 1994 Standardization of Spirometry Update highly recommends that a six second blow be the goal for all spirometry testing.1 To ensure that the patients take an adequate deep breath, it is valuable to emulate exactly what you expect. A good way to do this is through one of the filters. Prior to your demonstrating the maneuver, tell your patient to be especially aware of the latter portion of the blow when you are squeezing out the last bit of air. If the patient has a visual cue as to what a big deep breath is and can actually

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The Spirometry Source see and hear a forced expiration, they are more apt to perform well. Body language is the key to good performance. Instruct the patient to put the AstraGuard filter between his/ her teeth and make a good, tight seal with his lips. After the patient slowly makes a maximal inspiration, the first phase of the test, loudly exhort the patient to BLAST out. This element of surprise will help the patient to realize the maximum peak flow, which is the second phase of the test. The third phase of the test, which involves diminished flow, is important to achieve the highest possible volume of patient FVC. Traditionally, technicians have loudly instructed the patient to blow, blow, blowkeep going, keep going! to achieve the maximal forced volume, when the opposite approach may actually be more effective. Evidence suggests that using the soft sell may be better for achieving the best performance during the third phase. Draw [the patients] 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 keep going; I can see youre still getting more air out.2 This is a critical part of the test, since an obstructed patient may actually still be expelling a volume of air, but it may not seem apparent, and many times the test is stopped too soon. 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. Another key indicator might be to note the FET (Forced Expiratory Time) that is sometimes displayed as part of the data. If the time was appreciably shorter than six seconds, this would suggest that the patient ended the test too quickly.

Performing Spirometry

European Respiratory Journal. Standardisation of Spirometry. Eur Resp J 2005; 26:319-338

Enright, Paul L., MD. How to Make Sure Your Spirometry Tests Are of Good Quality. Respiratory Care August 2003; 48:774.

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LIMITED WARRANTY CONDITIONS

The Spirometry Source

Limited Warranty Conditions

This SDI product together with its standard accessories is guaranteed for a period of ONE YEAR from the date of purchase. In the case of any warranty claims the relevant sales invoice (or another proof of purchase document) must be submitted to SDI. The instrument must be checked at the time of purchase and any claims must be made immediately in writing to SDI. This warranty covers the repair or the replacement (at the discretion of the manufacturer) of the product or defective parts. All batteries and other consumable parts are specifically excluded from the terms of this guarantee. The warranty is not valid in the following cases: Problems due to improper installation or operation of the machine, or if the installation does not conform to the current 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 out by personnel not authorized by SDI. Problems caused by lack of or incorrect routine maintenance of the machine. If the machine has been dropped, damaged or subjected to physical or electrical stress. If the fault is caused by the power source or by another product to which the instrument has been connected. If the serial number of the instrument is missing, tampered with and/ or not clearly legible. The customer is responsible for the transportation and all transport and customs charges for delivery of the goods both to and from SDI. Any instrument or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found. 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.

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The Spirometry Source

Spirometry Indications
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) Obesity Pre-operative testing Occupational exposure to dust and/or chemicals Ongoing assessment of patients receiving bronchodilator treatments Determination and/or documentation of pulmonary disability Asthma diagnosis Pre-existing pulmonary disease Frequent colds Assessment of congestive heart failure

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