Astra 200 Users Manual

The Spirometry Source

1-800-678-5782 1-508-238-7033www.sdidiagnostics.com

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Distributed by:

SDI Diagnostics, Inc., 10 Hampden Drive, Easton, MA 02375National Sales: 1-800-678-5782 1-508-238-7033Email: [email protected]: 1-508-230-2752

2User’s Manual


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TABLE OF CONTENTS

DECLARATION OF CONFORMITY ......................................... 4

SAFETY ............................................................................... 5

1. INSTRUCTIONS FOR USE AND INSTALLATION............ 6

1.1 INTRODUCTION.......................................................... 7

1.2 LAYOUT OF CONTROLS, PILOT LIGHTS ANDCONNECTORS ............................................................. 8

1.3 INSTALLATION AND START-UP..................................... 9

CLEANING THE TURBINE........................................... 10

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


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

STANDARD PARAMETERS ...........................................14

2.1 FUNCTION TREE ........................................................15

2.2 EQUIPMENT CUSTOMIZATION ...................................18

2.3 EQUIPMENT PROTECTION .........................................21

2.4 FORCED VITAL CAPACITY «FVC»TEST PROCEDURE ......................................................22

QC GRADES ...............................................................44

PRINTING THE REPORT .............................................39

2.5 SLOW VITAL CAPACITY «VC»TEST PROCEDURE ......................................................46

2.6 MAXIMUM VOLUNTARY VENTILATION «MVV»TEST PROCEDURE .....................................................48

2.7 POST BRONCHODILATOR SPIROMETRYPROCEDURE ..............................................................50

2.8 CALIBRATION PROCEDURE ........................................53

2.9 INTERNAL DATABASE ................................................59

2.10 MAINTENANCE PROGRAM ..........................................63

2.11 UPDATING INTERNAL SOFTWARE ..............................70

3.0 PERFORMING SPIROMETRY .......................................74

4.0 LIMITED WARRANTY CONDITIONS ............................76

SPIROMETRY INDICATIONS ......................................77


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SPECIAL PRECAUTIONSThe ASTRA 200 spirometer has been designed for usewith safety in mind. All operating instructions must beread before using the ASTRA 200. Not doing so may leadto injuries to the user or the patient and damage toequipment and/or accessories.

INTENDED USEThe spirometer measures and calculates a series ofparameters related to human respiratory function.This instrument is designed for use by medical staffand by the patient when supervised and instructed bya doctor.The spirometer is not designed for use outdoors or underother conditions or using other power sources notindicated in this manual.

EFFECTS ON PATIENTS USING THE SPIROMETERThe spirometry tests require patient cooperation. Completeforced expiration is required to obtain significant patientFVC values. The doctor must assess the patient’s capacityto perform the spirometry test.

LIMITATIONS OF USE. CONTRAINDICATIONSAn analysis of the results of a spirometry test is not enoughin itself to give a correct diagnosis of the patient’s clinicalcondition. The patient’s records and any tests that thedoctor believes necessary must therefore also be considered.

A doctor must interpret the tests to determine the courseof treatment needed.

The patient’s symptoms must be taken into account bymedical staff before any spirometric test is undertaken.


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ELECTRICAL RISKSDot NOT disassemble the equipment casing. The device mustonly be serviced and repaired by skilled personnel. Thecontact with voltage inside the system may cause seriousinjury.

Do NOT use damaged accessories.

Do NOT submerge the electronic parts of the device in anyliquid.

To ensure vital safety features under the EN 60601-1-1standard, only equipment compliant with the electrical safetystandards in force may be connected to this device.

The equipment must be stored and used within thetemperature, pressure and humidity ranges specified.

RISKS OF EXPLOSIONDo NOT use the equipment in the presence of volatileanesthetics or inflammable gases.

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


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1. INSTRUCTIONSFOR USE ANDINSTALLATION


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1.1 INTRODUCTION

The Astra 200 spirometer is a compact device with ahigh-resolution LCD display. It is designed to function witha turbine-type transducer and may be be connected toan external printer via a supplied USB cable.

The entire system is controlled by a microprocessor forthe acquisition, calculation and presentation ofalphanumeric and graphical data.

Part No. Qty. Description29-5200 1 SDI Astra 200

10 AstraGuard Bacterial/Viral Filters10 Noseclips1 Quick Reference Card2 AA 1.5 V Alkaline Battery1 Turbine Transducer

29-5021 1 Cable Mini USB (PC Link)29-5022 1 Cable Mini USB(External Printer Option)

ASTRA 200 LIST OF CONTENTS

29-799029-796629-501729-502329-5003


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1.2 LAYOUT OF CONTROLS, PILOT LIGHTS ANDCONNECTORS

1- On/off button2- Alphanumeric LCD display3- Keypad4- Turbine transducer5- USB connection6- RS·232 series connection7- Specifications plate8- Lithium battery (CR1632)9- Firmware loading

switch10- Main batteries

(2xAA 1.5V)

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1.3 INSTALLATION AND START-UP

Astra 200 INSTALLATION

The ASTRA 200 spirometer is CLASS IIa device accordingto the criteria of the 93/42/EEC European Medical DeviceDirective and, in line with the type of protection againstelectric shocks established by the EN60601.1 standard,the equipment is rated as CLASS IP type B.

BatteriesThe Astra 200 spirometer works as standard using two AA1.5 V batteries or optionally using rechargeable NiMHbatteries (AA 1.2 V type).

WARNING:Never try to recharge alkaline batteries. This wouldcause damage to both the batteries and the charger.

In both cases, the battery charge will depend on the qualityof the batteries used. 1.5 V alkaline batteries or 2400 mAhrechargeable batteries will last for approximately 40 hours.The charging time for rechargeable NiMh batteries will dependon the charger used.

To save power, the equipment includes an auto switch offsystem that turns the equipment off when a key has notbeen pressed for 5 minutes, except in main spirometryscreens. In this case, the data on the screen is lost and thenormal process must be followed to restart the equipment.

NOTE:When inserting the batteries for the first time or whenreplacing them, the equipment may switch on automatically.This is normal and does not indicate malfunction.


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Atmospheric conditionsThe atmospheric working conditions are:

• Ambient temperatures between 10º and 40ºC.(The American Thoracic Society recommends 17º to40ºC)

• Relative humidity below 75% (without condensation)

• Atmospheric pressure from 430 to 800 mmHg (fromapproximately 4500 to - 400 meters)

CLEANING THE TURBINE

ATTENTION: to avoid the very serious risk of cross-contamination when using turbine with plain cardboardmouthpiece, the turbine must be cleaned after everyuse. Alternatively, the use of one-way valvemouthpieces and/or bacterial/viral filters is stronglyrecommended.

· 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 solutionand move it inside the solution to remove any impuritiescontained both inside and outside the turbine tube. Letit soak for the time specified in the instructions of thesolution, generally for at least 20 minutes;

· If directed by the manufacturer of the disinfectionsolution, soak the turbine in a small bowl of water for 3minutes. Do no allow water from a running faucet topass through the turbine. Doing so may damage thetransducer.

· Shake the turbine to shake off the excess solution andleave it to dry on a clean surface in an upright position;

· When the turbine is dry or almost dry insert it into thespirometer.


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NOTE:The first time the equipment is started, theprotection is disabled and the PIN is set to 0000.See Section 2.2/3.2 EQUIPMENT CUSTOMIZATION toenable it and configure the PIN.

HANDLING THE EQUIPMENT

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



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2.0 Astra 200OPERATION


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FVCFVC - Forced Vital CapacityFEV1 - Forced Expiratory Volume in 1 secondFEV1/FVC - Ratio of FEV1 to FVCFEV6 - Forced Expiratory Volume in 6 secondsFEV1/FEV6 - Ratio of FEV1 to FEV6FEV .5 - Forced Expiratory Volume in ,5 secondsFEV3 - Forced Expiratory Volume in 3 secondsFEV.5 / FVC - Ratio of FEV.5 to FVCFEV3 / FVC - Ratio of FEV3 to FVCFEV1 / VC - Ratio of FEV1 to Slow Vital CapacityFEF25% - Maximum Expiratory Flow @ 25% of blowFEF50% - Maximum Expiratory Flow @ 50% of blowFEF75% - Maximum Expiratory Flow @ 75% of blowFEF25%-75% - Avg. Forced Expiratory Flow between 25% and 75% of blowFEF75%-85% - Avg. Forced Expiratory Flow between 75% and 85% of blowFET25%-75% - Expiratory Time between 25% and 75% of blowFET 100%- Total forced expiratory timeFEF50%/FIF50% - Maximum Expiratory Flow@50%/Mean Inspiratory Flow@50%FEV1 / FEV.5 - Forced Expiratory Volume @1 sec / Forced Expiratory Volume @ .5 secFEV1 / PEF - Forced Expiratory Volume @1 sec / Peak Expiratory FlowFIF50% - Maximum Inspiratory Flow @ 50% of blowFIVC - Forced Inspiratory Vital CapacityFIV1 -Forced Inspiratory Volume in 1 secondFIV1 / FVC - Ratio of FEV1 to FVCFEV1 / FIV1 - Ratio of FEV1 to FIV1PIF - Peak Inspiratory FlowMTT - Mean Transit TimePEF / PIF - Ratio of PEF to PIFBEV - Back-extrapolated VolumeCOPD Ind - COPD IndexPEF - Peak Expiratory flowLung Age

MVV - Maximum Voluntary VentilationBr/min - Breaths per minute

VC - Slow Vital CapacityTV - Tidal VolumeERV - Expiratory Reserve VolumeIRV - Inspiratory Reserve VolumeIC - Inspiratory CapacityTi - Inspiratory timeTe - Expiratory timeTt - Total TimeTi/Tt - Ratio of Ti to Tt

Astra 200 Parameters (Selectable)


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2.1 FUNCTION TREE

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

The Astra 200 has 4 silicon keys located underneath thescreen to move around the different menus in the equipment.

In general, the and keys enable youto move around the different menu options.

The key provides access to the selected option and

the key takes you back to the previous menu.

The following can be accessed from the Main Menu,depending on the options included:

1. SPIROMETRY2. CALIBRATION3. DATABASE4. CUSTOMIZE5. MAINTENANCE6. BLUETOOTH

1.SPIROMETRY

1. FVC (Forced Vital Capacity Test)1. Start maneuver2. Results3. Interpretation4. Save DB5. Save PRE6. Print Report7. Delete8. New patient


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2. VC (Slow Vital Capacity Test)1. Start maneuver2. Results3. Save DB4. Save PRE5. Print Report6. Delete7. New patient

3. MVV (Maximum Voluntary Ventilation Test)1. Start maneuver2. Results3. Save DB4. Save PRE5. Print Report6. Delete7. New patient

4. Bronchodilation (Post-Drug)1. PRE maneuvers1. Delete PRE

5. Total Report

6. New Patient

2. CALIBRATION1. Check Calibration2. Calibration

3. Calibration DB1. Register Data2. Delete Register3. Print Report

3. DATABASE1. Explore DB2. Search patient3. Search register4. Summarized report5. Delete DB


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4. CUSTOMIZATION

1. Spirometry1. Predicteds

1. Adults2. Children3. Ethnic Factor

2. Parameters1. FVC2. VC3. MVV

3. Graphs4. Interpretation5. Post BD Mode6. Alerts

2. Printers

3. Standard1. Load standard2. Modify standard

5. Battery6. Language7. Set clock8. PIN

5. MAINTENANCE

1. Select Alerts2. LCD contrast

3. Equipment check1. Ext.Printer2. ADC’s3. LCD4. CPU5. Auto On/Off


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4. Equipment config.1. Reset2. Reindex3. VC Mode4. Updt. Key

5. Standard curves1. FVC2. VC3. MVV

6. Bluetooth

2.2 EQUIPMENT CUSTOMIZATION

Every user should customize the Astra 200 spirometeraccording to his requirements due to the multiple variety ofoptions included.

The different options included in the Customization menuare explained in detail in the previous section.

SPIROMETRY CUSTOMIZATION

This option customizes any suboptions specific to thespirometric tests

1. PredictedsThe 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 includesan optional ethnic correction. The NHANES III predicted setallows the choice of three different ethnicities-Caucasian,Afro-American or Hispanic.


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It prioritizes the age range selected for adults if a differenttable is chosen for children and extrapolates the values forthe ages outside the table range selected.

2. ParametersThe observed or measured parameters to be calculated andreported are selectable. This is only at display level or forthe report. All the parameters are saved to the databaseand can be enabled at any time.

3. GraphicsThe graphics can be saved to the database.

4. InterpretationOne of four different interpretation modes can be selected.These are Miller, Kory/ Lyons, NLHEP or ATS.

5. Bronchodilation modesOne of several comparison modes can be selected for thePOST-Drug function.

6. WarningsThe printing of Non-conformity warnings regarding theoperations with ATS/ERS criteria can be selected.

PRINTER CUSTOMIZATION

In this option you can choose if you want to print in blackand white or color. The Astra 200 interfaces only with HP-PCL printers.

To be able to print from the equipment you must:

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

2 Connect the equipment to the external printer usingthe Mini USB cable included with your Astra 200 spirometer


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3 Switch the printer on.

STANDARD CONFIGURATION

This option memorizes a user-defined customization programstatus to retrieve it at any time globally and automatically.This option restores the original customization if it has beenmodified either voluntarily or by accident. In general, thisconfiguration will correspond to that most often used.

1. Retrieve StandardThe configuration saved can be loaded as standard.

2. Modify StandardThe configuration to date can be saved for use as standard.

BATTERY CUSTOMIZATION

The Astra 200 works with two types of battery (alkaline orNiMh), independent to the battery selected in this section.This selection only affects the calculation made inside theequipment 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 theequipment (if the protection option is enabled) and to enableor disable equipment protection.The following screens will appear successively:


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CHANGE PINCurrent Pin: 0000

CHANGE PINPin Enabled: Yes

CHANGE PINNew(1): 0000

CHANGE PINNew(2): 0000

To enable protection, select YES on the Pin Enabled screenand enter the PIN in the New(1) and (2) screens.To change the PIN, you must enter the current one. If anerroneous PIN is entered three times, the equipment willlock and will switch off.See the following section (2.3 EQUIPMENT PROTECTION).

2.3 EQUIPMENT PROTECTION

If equipment protection has been enabled, the followingscreen will appear when it is started:

ENTER PIN Pin: 0000

If the PIN configured in Equipment protection customizationis entered, access will be given to the Astra 200 and themain screen will appear.

If an invalid PIN is entered three times, the equipment willlock and will switch off. The following screen will appearwhen it is restarted:


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UNLOCK CODE00000000000000

Enter the unlock code (PUK) supplied on purchasing theequipment.If the correct code is entered, the Astra 200 will unlockand the main screen will appear. From then on, the equipmentwill return to its initial status (Protection disabled and PIN0000).If an erroneous code is entered, the equipment will remainlocked.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 ForcedVital Capacity «FVC», slow Vital Capacity «VC» andMaximum Voluntary Ventilation «MVV» tests are verysimilar. Therefore, only one detailed description will be givenin this section.

ENTERING PATIENT PARAMETERS

Start the Astra 200 using the key and wait for thefollowing screen to appear:

MAIN MENU1 Spirometry

Press the key and the following will appear:


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SPIROMETRY1 FVC

Press the key and the following will appear:

PATIENT DETAILS Code: 0000000000

Enter the patient code (between 0 and 9999999999).

Select the digit space using the or keys and

or to set the value for each digit.

Press the key to confirm and go to the next digit

until the ID number is completed.

PATIENT DETAILSAge (years): xx Between 4 and 100

PATIENT DETAILSHeight (in): xxx Between 20 and 90 inches

PATIENT DETAILSWeight (Lb): xx Between 33 and 441 pounds

PATIENT DETAILSSex: Male Between male and female


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PATIENT DETAILS Between 0 and 200 packsI. Smoker: xx a day times number of

cigarettes

PATIENT DETAILSCig/day: xx Between 0 and 20

PATIENT DETAILSEthnic F.: xxx Between 80 and 120%

The Smoker Index is the same as the number of cigarettessmoked a day divided by 20 and multiplied by the number ofyears smoking (cigarettes day x years smoking / 20).The ethnic factor is used in areas without any parametersof reference that use some existing yet corrected in a certainpercentage. This factor MUST BE SET TO 100 IF NOT USEDand can only be modified through the Customization Program.

Press the key to go to the FVC TEST screen.

Use the 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


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• FVC TEST 4 Save DB

Saves the selected maneuver to the Database

• 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 datailsof an existing patient

ENTERING FORCED VITAL CAPACITY «FVC» TESTS

To carry out the forced spirometry tests, the technicianmust know the normal procedures required so that thepatient can be coached. Where this is not the case, certaindocumentation on the matter must be reviewed.

When doing spirometry testing, be sure to take the followingsteps:


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1 Check that the turbine is correctly installed and theAstraGuard filter is correctly inserted, as in the figure:

2 Instruct the patient as to how to carry out the test, ashis cooperation is vital for it to be completed correctly.Patients can carry out the spirometry maneuvers in twodifferent ways:

• The first method consists of a patient inhaling to TLC,followed by a FORCED EXPIRATION followed by FORCEDINSPIRATION (if the inspiratory data is required).

• The second method consists of the patient breathingtidally through the turbine and, when directed by thetechnician, filling his lungs to TLC followed by a FORCEDEXPIRATION which may be followed by a forced inspiration,if inspiratory data is required.

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

INSERT FIRMLY


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4 Select the screen 1 Start Maneuv. and press

the key. The following screen will appear:

MEASURING

The equipment is held so that the technician can see thescreen while the patient is carrying out the tests.

On the left-hand side is a rectangle indicating that theequipment is ready for the test to be started. The patienthas 30 seconds to begin. After this time, if he has notstarted, the equipment will switch to standby and must bereactivated.

After the expiratory maneuver, the second line of the screenwill show a bar, movement of which is proportional to thevolume of the expiratory maneuver. The maximum value ofthe bar corresponds to a volume of 6 liters.

At the end of the maneuver, one or more of the warnings, ifenabled in the Customization Program, may appear toalertthatthe maneuver is not in compliance with ATS/ERS Criteria.An indication is given to inform you that the maneuver hasnot been carried out according to one of the following ATS/ERS criteria:

ET - Indicates that expiratory manuver has not completedsatisfactorily, as the variation on volume in the last secondof the maneuver was above 25 ml, or the maneuver haslasted less than 6 seconds (in patients aged over 10 andmore) or less than 3 seconds (in patients aged 10 or less).

EX - Indicates that the start of expiration was notsatisfactory, as the extrapolated volume is above 5% of theFVC or 0.15 litres. The ATS/ERS recommends it be less than5% of the FVC or 0.15 liters, whichever is higher.


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The technician performing the spirometry testing may, whereconsidered appropriate, disable these warnings in theCustomization Program. In this case, they will also be removedfrom the printed report.

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

5 Press the key if the alerts are enabled.

If you have chosen the NHANES predicted set and the NLHEPInterpretation program, the following alerts may appear:

QUALITY CONTROL: If Back extrapolated volume (BEV) Don’t Hesitate >150 mL

QUALITY CONTROL: If expiratory time (FET) <6.0 sec & Blow Out Longer EOTV (End-of-test volume) >40mL

QUALITY CONTROL: If Peak expiratory flow (PEF) Blast Out Harder >1.0L/sec

QUALITY CONTROL: If FEV6 match>150mL Deeper Breath

QUALITY CONTROL If Peak expiratory flow time (PEFT) Blast Out Faster >120 msec

After the alerts are displayed, the following screen or similarwill be shown, depending on the parameters selected in theCustomization Program.

FVC X.XX YY%FEV1: x.xx yy%


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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 thatthe Predicteds and/or the Ethnic Factor are suitablyselected. The Ethnic Factor modifies the value of thePredicteds according to the percentage selected. 100%is equivalent to the unmodified standard value of thePredicteds.

Using the selection keys or it is possible to

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

6 Press the key again and complete a newmaneuver. As many maneuvers as required can be completed.

The Astra 200 will always save the five best FVC and VCand the three best MVV maneuvers according to ATS/ERScriteria (*).No more than eight maneuvers should be attempted to avoidtiring the patient.

If three or more maneuvers have been completed and theFVC and/or FEV1 parameters are flashing, this indicates thatthe repeatability criteria for one or both parameters hasbeen met. These criteria indicate that the best two observedvalues of FVC and the best two of FEV1 differ in no morethan 120 ml if the FVC is greater than 1 liter or in no morethan 100 ml if the FVC is less than or equal to one liter.


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NOTE: Remember that the back key takes you back inthe menu without losing the current data, except whereyou enter a new patient or select a previous patient fromthe database.

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

DISPLAYING RESULTS

The results can be seen once at least one maneuver hasbeen completed. To do so, go back to the following screen

FVC TEST 1 Start Maneuv.

and, using the or keys, select the option

FVC TEST2 Results

Press the key and a similar screen to the followingwill appear:

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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This screen indicates the following:

• Number of maneuvers in memory. There may be fromone to five maneuvers.

• The maneuvers are sequenced according to ATS/ERScriteria (*) explained in the previous section, with M1 thebest and M5 the worst.

• The maneuver between brackets [M3] indicates theposition taken by the last maneuver entered.

• The flashing text indicates the maneuver selected.

To display the results, press .

To select another maneuver, press the keys or

Therefore, the brackets [ ] and the flashing text do nothave to match.On accessing the results of a test, the best FVC (mFVC)and the best FEV1(mFEV1) will appear first, followed bythe results of the selected maneuver. The best FVC andFEV1 values may correspond to any of the availablemaneuvers.

INTERPRETATIONS

The Astra 200 spirometer has several interpretation schemathat can be selected in the Customization Program.

NOTE:If you do not agree with these criteria, do not use themas a reference for diagnosis.

The interpretation and the results of the test mustalways be validated by the clinician.

• Miller InterpretationThis presents the following information: NORMAL,RESTRICTIVE, OBSTRUCTIVE or COMBINED, according to the


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criteria in the following chart:

• Snider, Kory & Lyons InterpretationThis is based on the following criteria:

If FVC > 80% of the FVC Referenceand FEV1 > 80% of the FEV1 ReferenceValues in the range of reference. Normal Diagnosis

If FEV1/FVC% < FEV1/FVC% Referenceand FEV1 < 80% of the FEV1 ReferenceObstructive ventilatory disturbanceFEV1 < 80% SlightFEV1 < 65% Moderate


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FEV1 < 50% IntenseFEV1 < 35% Very Intense

If FEV1/FVC% < FEV1/FVC% Referenceand FVC < 80% of the FVC ReferenceNon-obstructive ventilatory disturbanceFVC < 80% SlightFVC < 65% ModerateFVC < 50% IntenseFVC < 35% Very Intense

If FEV1/FVC% < FEV1/FVC% Referenceand FVC > 80% of the FVC ReferenceMixed ventilatory disturbance is suspected

If FEV1/FVC% < FEV1/FVC% Referenceand FEV1 > 80% of the FEV1 ReferenceMixed ventilatory disturbance is suspected

If the POST bronchodilation test is carried outand the FEV1 POST exceeds the base FEV1 or PRE by 15%,there is a positive response to the bronchodilator

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


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Repeatabilty

In keeping with ATS/ERS guidelines, the Astra 200 will alertyou of test repatability for FVC and FEV1 when two testsmatch within <150mL of each other unless the FVC is lessthan 1 Liter; then it is <100mL. If repeatability occurs, thefollowing screen will be displayed

REPEATABILITY FVC:Yes FEV1:Yes


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QC GRADES

Quality Control grades will be assigned according to thefollowing guideline

A = At least 2 acceptable maneuvers with the largest twoFEV1 values matching within 100 mL and the largest 2 FEV6values matching better than 100 mL

B = At least 2 acceptable maneuvers with FEV1 valuesmatching matching between 101 and 150 mL

C = At least 2 acceptable maneuvers with FEV1 valuesmatching between 151 and 200 mL

D = Only one acceptable maneuver, or more than one, butthe FEV1 values match >200mL (no interpretation)

F= No acceptable maneuvers (no interpretation)


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SAVING FVC TESTS

Saving a test in the Internal Database

The Astra 200 spirometer has an Internal Database thatcan save different tests to be subsequently transferred toa PC Database using AstraPro Spirometry Software.This base may be of the «L» or «H», depending on itscapacity.

The process is similar to that described in the DISPLAYINGRESULTS section, although previously selecting the option

FVC TEST4 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/ERScriteria (*), with M1 the best and M5 the worst.

• The maneuver between brackets [M3] indicates theposition taken by the last maneuver entered.

• The flashing text indicates the maneuver selected (thebest [M1] is selected by default)

Select the maneuver to be saved using the keys

and (appearing between brackets) and press .


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The following screen will appear for a few seconds:

MANEUVER N.: X SAVED

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 thebest (ET, EX). With the same number of warnings,the maneuver with the highest sum of FVC+FEV1 isconsidered the best.

Saving a PRE bronchodilator test for a comparison to aPOST bronchodilator test

This option allows for a test to be saved in PRE bronchodilatormode which can be recalled at a later time to then compareit 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 TEST5 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


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SAVE PREM1 M2 [M3] M4 M5

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 thefollowing guideline

A = At least 2 acceptable maneuvers with the largest twoFEV1 values matching within 100 mL and the largest 2 FEV6values matching better than 100 mL

B = At least 2 acceptable maneuvers with FEV1 valuesmatching matching between 101 and 150 mL

C = At least 2 acceptable maneuvers with FEV1 valuesmatching between 151 and 200 mL

D = Only one acceptable maneuver, or more than one, butthe FEV1 values match >200mL (no interpretation)

F= No acceptable maneuvers (no interpretation)


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PRINTING THE REPORT

The Astra 200 spirometer can print any maneuver madeusing an external printer.

The process is similar to that described in the previoussection, but previously selecting the option

FVC TEST 6 Report

Press the key and the following screen will appear:

REPORT[M1] M2

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

The printer will present a report similar to the one on thefollowing page:

This will include the parameters and graphs correspondingto the selected curve.If you do not want graphs, certain parameters, interpretationand/or ATS/ERS warnings to appear, disable them as describedin Section 2.2. EQUIPMENT CUSTOMIZATION.

PLEASE NOTE:THE BEST MANEUVER CORRESPONDS TO THE ONE SAVEDIN POSITION «M1» AND WILL BE SELECTED BY DEFAULT.

If you want a global printout of the report, including theFVC, VC and MVV tests made on a patient, follow the stepsdescribed in the General Report Printing Section.


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The following screen will appear during the printing process:

PRINTING

The top line indicates the percentage of the report produced.

Printing can be cancelled at any time by pressing the

key .


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DELETING A MANEUVERThe Astra 200 spirometer deletes any maneuver.

The process is similar to that described in the previoussection, but previously selecting the option:

FVC TEST 7 Delete

Press the key and a similar screen to the followingwill appear:

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.

If you press the key to delete the maneuver, the

following screen will appear:

MANEUVER N.: X DELETED


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OTHER TESTS ON THE SAME PATIENT

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

• 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 reportcontaining, if desired, all tests before going on to anotherpatient.

From the next screen and using keys or selectany of the first four options.

CHANGE PATIENT

This option is used to enter a new patient or to changesome details of an existing patient.The process is similar to that described in the previoussection, but previously selecting the option:

FVC TEST8 New patient

Press the key and the following screen will appear:

PATIENT DETAILSCode: 0000000000


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Enter the patient code required (between 0000000000 and9999999999).If you wish to modify some details of an existing file, enterthe appropriate ID code.

Follow the procedure designed in the ENTERING PATIENTPARAMETERS procedure to enter the details of a new patientor to modify the details of an existing patient.

If you have not saved the tests completed to date, thefollowing warning will appear after the last screen of data:

DELETE UNSAVED TESTS? YES> NO<

If you press , the tests completed will be saved in the

database.

If you press , the tests completed will not be savedin 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, theparameters will be recalculated reflecting the changesmade.


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2.5 SLOW VITAL CAPACITY (VC) TESTPROCEDURE

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

1 If the test is carried out on the same patient, as describedin the OTHER TESTS ON THE SAME PATIENT section,

go back using the key to the Test Selection

window and select, using keys or , the VCtest.

SPIROMETRY2 VC

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

2 In order for the test to produce meaningful results, thepatient must be carefully instructed on how to perform thetest.

3 The maximum time allowed for the maneuver is 45seconds. The spirometer will evaluate all tests and savethe values from the best test.

4 To measure the ERV and TV parameters correctly, eachmaneuver must have at least four inspire:expire cycles.

5 The tabular and graphical report is as shown on thefollowing.


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2.6 MAXIMUM VOLUNTARYVENTILATION (MVV) TESTPROCEDURE

The procedure to carry out the Maximum VoluntaryVentilation (MVV) test is similar to that described inSect ion 2.4 FORCED VITAL CAPACITY (FVC)PROCEDURE with the following:

1 If the test is carried out on the same patient, as describedin the OTHER TESTS ON THE SAME PATIENT section,

go back using the key to the Test Selection

window and select, using keys or , the MVVtest.

SPIROMETRY 3 MVV

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

2 Instruct the patient as to how to carry out this type oftest, as his cooperation is vital for it to be completedcorrectly.

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

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


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2.7 POST BRONCHODILATORSPIROMETRY PROCEDURE

The Astra 200 spirometer allows for Post bronchodilator teststo be carried out in FVC, VC and MVV provided a test haspreviously be completed in PRE bronchodilator mode and savedto the database.

The purpose of this operating mode is to provide reportingPRE and POST spirometric results after administration of abronchodilator.

The procedure to carry out Post bronchodilator Spirometry isas follows:

1 Complete a FVC, VC or MVV test on the patient beforeadministering the bronchodilator, as described in the previoussections.

2 Save the PRE test in the database to compare it inPOST mode, as explained in SAVING FVC TESTS in Section2.4.

3 Administer to the patient the appropriate dosage ofbronchodilator as prescribed by the clinician and wait for theprescribed period.

4 Go back using the key to the Test Selection

window and select, using keys or ,

SPIROMETRY 4 Post-Drug

Press the key to select the screen:

POST-DRUG 1 PRE maneuvers


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Press .

The tests saved in PRE mode will then be displayed.

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

press

6 Proceed as indicated in Section 2.4 FVC TESTPROCEDURE.

The only variation is in point 5, as the % is weighted inrelation to the observed values in Pre bronchial and Postbronchial mode.

If the printed report is requested, the data is presented asshown 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 Applicationin Medicine. Blackwell Sci. 4th Edition 1979, p52-53)


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2.8 CALIBRATION PROCEDURE

GENERAL OBSERVATIONS

For the most part, the Astra turbine, because of itsmechanical design, needs calibrating infrequently. It isimpervious to changes in pressure, gas viscosity andmoisture. The Company understands, however that thereexist protocols that call for daily calibration. ATS guidelinescall for a daily Calibration Check. This assures that thecalibration of the device is within factory specifications.The Calibration Check function in your Astra spirometeris a quick and easy way of assuring you that yourspirometer is accurate.

Generally accepted practice in spirometry recommends thatall spirometers be perfectly calibrated. This is due to thealterations that may modify the characteristics of theelectronic circuits and mechanical parts over time andcause a change in the spirometer calibration factors.Hence, a calibration system has been incorporated basedon a volume signal of reference (e.g. a syringe).

Furthermore, this calibration factor must take into accountthe changes in volume associated to atmospheric conditions.The most influential factor is temperature.

The Astra 200 includes a Calibration Program for fast (lessthan one minute) and easy checking and auto-correctingof diversion in the measurements taken based on astandard or reference volume for the quality control ofthe different spirometric tests.The regularity of calibrationdepends on the user.

CALIBRATION PROCESS


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The calibration process is as follows:

1 Install the spirometer and the syringe as in the following:

2 Power up the Astra 200 using the key and waitfor the following screen to appear:

MAIN MENU 1 Spirometry

3 With the keys or select:

MAIN MENU 2 Calibration

4 Press , the following screen will appear:

CALIBRATION 1 Calibration

5 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


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NPulses = 200) and the calibration process is completed.

NOTE:Where no syringe is available, the value entered inVolume is not relevant and is not taken into accountwhen automatically calibrating the equipment.

6 Press . The following screen will appear:

CAL. DATANo. Pulses: xxx

If the number of pulses associated with its turbine is asappears on screen, continue without modifying it.If it is different, enter the number of turbine pulses. In thiscase, the factors are calculated and the calibration processcompleted.

NOTE:Each turbine is factory calibrated individually and isassociated to a factor equivalent to the pulses/literdetected (etched on the turbine body). Althoughvariability between turbines is within ±3%, to obtainthe maximum measurement precision, it is worthwhileto enter this factor in the spirometer if the turbine ischanged.

Where no syringe is available, it is very important toenter the No. of Pulses of the turbine so that theequipment can be automatically calibrated.

7 Press . The ambient temperature (ºC) detected

is based on the reading of an internal thermistor. This readingcan be modified if required.

CAL. DATA Temp (ºC): xx


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8 Press . The relative humidity (%) entered in

the last calibration will appear. This can be modified ifrequired.

CAL. DATA Humidity (%): xx

9 Press . The atmospheric pressure (mmHg)entered in

the last calibration will appear. This can be modified ifrequired.

CAL. DATA Pres(mmHg): xxx


CALIBRATION Start Calibra.

11 Press again and start emptying the syringe for

two or more consecutive cycles (one cycle is equal toemptying and filling the syringe). When emptying and fillingthe syringe piston must move all the volume used as areference. If this is not done correctly, the equipment willdetect it as «incorrect maneuvers».Furthermore, this process should be completed in a regularand uniform manner, without causing flow rates that are toohigh or too low. Where this is not the case, you will be toldto repeat the maneuver.


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The time of each cycle (emptying plus filling the syringe)must be no less than four seconds and no more than tenseconds.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 abar, movement of which is proportional to the volume applied.On completion, the following screen will appear if theprocedure was accepted:

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 button andwait for the following screen to appear:


3 With the keys or select:

MAIN MENU 2 Calibration


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CALIBRATION 1 Check Calibra.

5 Press and the following screen will appear

CALIBRATION Start Cal Check

6 Press again and start emptying and filling thesyringe

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 youwith 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 andinspiratory factors of the last ten calibrations or calibrationchecks performed. This is extremely useful for centersrequiring a quality control of the processes and protocols


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To access this register, select the option:

CALIBRATION 2 Calibration DB

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 thatsaves the different tests made using the equipment andsubsequently displays them, prints them and/or transfersthem to a PC or other computerized system for storage ormanagement.


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The base information remains, even when the equipment isunplugged.

The tests that can be saved (using a six-second FVC asreference) are:

Database «H» >1100

The saving of the tests has already been described in thesections corresponding to each test.

The database always saves all the spirometric parametersof each of the different test modalities, FVC, VC, MVV orPost-Drug, despite them not being selected in theCustomization program.

Different functions are possible from the spirometer:

1 Search the database2 Search for a patient3 Search for a register4 Print a summarized report5 Delete the database

To access the above selections, turn on the Astra 200

using the key and wait for the following screen toappear:


Using the or keys, select the option:

• Pat. Code Test2 Diagnosis

• Pat. Code Test 3 R t


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Press the key and with or

select the required function.

DATABASE SEARCH

The Astra 200 displays the parameters saved in thedatabase for each test. If this is to be carried out on aregular basis, use the AstraPro Spirometry Software toconveniently view all the saved parameters.

Select the option:

DATABASE1 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 and with or select

the option required:

• Pat. Code Test1 Results

• Pat. Code Test2 Diagnosis

MAIN MENU3 Database


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• Pat. Code Test 3 Report

• Pat. Code Test 4 Delete test

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


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To delete the entire database Press the key .

2.10 MAINTENANCE PROGRAM

The equipment has a maintenance program to adjust and/orcheck the working order of certain options.

From the Main screen, press keys orto choose:

MAIN MENU 5 Maintenance

Press the key to access the Maintenance options.

Using keys and , you can move around the

different options to:

1 Configure the calibration and/or maintenance warnings2 Adjust the screen contrast3 Auto-check the equipment4 Configure the equipment5 Check with pre-saved standard curves

WARNINGS


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Select the option:

MAINTENANCE1 Select Alerts

This option indicates the tests completed and allows for theperiods in days between calibrations or between preventivemaintenance work on the equipment to be defined.

If the days specified without calibration or maintenance areexceeded, the equipment warns of such by displaying a signevery time it is started. If 0 days is entered, a warning isnever 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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Press again and an information screen will appear

with the total number of tests completed.

Press a third time and an information screen will

appear with the number of tests completed since the lastmaintenance work.

LCD CONTRAST

Select the option:

MAINTENANCE• 2 LCD contrast

Using keys and , this option enables you to

configure the screen contrast.

EQUIPMENT CHECK

Select the option:

MAINTENANCE3 Equip. Check

This option allows for different parts of the equipment to bechecked.

Using keys and select:

• EQUIPMENT CHECK 1 Ext. Printer


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to check the external printer selected. The SIBELMED logowill be printed along with the heading lines and 10 lines ofcharacters.

• EQUIPMENT CHECK 2 ADCs

to see the values of the following variables:

• No. Pulses: 0150 Turbine Fact: 200

Alk. B.:OK +4V:OK• Li B :OK 26ºC

• EQUIPMENT CHECK 3 LCD

To test the LCD using a:

- Bar test: a bar is drawn alternately on the top and bottomline of the LCD.

- Contrast scan

• EQUIPMENT CHECK4 CPU

to check the CPU:

1 Calculates the flash checksum. The top line indicatesthe current direction and the bottom line the checksum.


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0x300000 Chk Flash:0x59D9

2 Calculates the bios checksum.

0x20000 Chk Bios :0xBA47

3 Tests the internal RAM: successively writing and readingthe value 0x55 in the internal RAM. The top line indicatesthe current direction and the bottom line the number oferrors in the write/read process.

• 0xFFEF00 Err CPU Ram: 0

4 Tests the external RAM: the same process as for theinternal RAM.

• 0x81E000 Err Ext Ram:0

• EQUIPMENT CHECK 5 Auto On/Off

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


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EQUIPMENT CONFIGURATION

Select the option:

• MAINTENANCE 4 Config. Equip.

This option allows for different options of the equipment tobe configured.


• 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).


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• CONFIG. EQUIP. 5 Update Key

to consult the updating key for the program in Flash.

ATS CURVES

Select the option:

• MAINTENANCE 5 Standard Curves

This option checks the correct working order of the equipmentusing pre-saved curves.


• STANDARD CURVES1 FVC

• STANDARD CURVES 2 VC

• STANDARD CURVES 3 MVV

Select the option and following the instructions on thescreen, which are similar to the FVC, VC and MVVprocedures. With these curves you can operate theequipment as if they were real patient curves, with slightexceptions.


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2.11 UPDATING INTERNAL SOFTWARE

The Astra 200 spirometer has two types of internalsoftware:

• BIOS (basic hardware control program)

• Flash (program containing all the equipment options)

The update option allows for the version of BIOS and/orFlash to be updated without having to send the equipmentto the factory and without having to open it.

WARNINGBoth updates are completed through the series port(RS232)

BIOS UPDATE

The updating process for the BIOS program is as follows:

1 Run the AstraPro Spirometry Software and accessthe Configuration - Hardware Test option.Run a communications test to check that the connectionsare correct.

2 Switch the equipment off.

3 With the Astra 200 switched off, remove the rear cover,disconnect the Bluetooth module (where applicable) and turnboth switches ON.

WARNINGThis option should be carried out by qualified personnel.


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4 Turn the equipment and support it on the table withthe screen visible.

5 Press the key for 1 second and release. Nothingwill appear on the screen.

6 Copy the BIOS file (DMBios.tsk) into the \FIRMWAREdirectory of the application (AstraPro).

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

8 Access the Configuration - Utilities - Update BIOS option.

9 Follow the instructions on screen and wait for the processto end.

10 Once completed, turn both updating switches OFF again,reconnect the Bluetooth module (where applicable) and closethe cover.

FLASH UPDATE

Flash can be updated for a new version of the program (inwhich improvements have been included) or to add anothermodule 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 equipmentbefore starting the update process:

Switch the Astra 200 on and select the following from themain menu MAIN MENU

5 Maintenance


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Access the option

MAINTENANCE4 Config. Equip.

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 accessthe Configuration - Hardware Test option.Run a communications test to check that the connectionsare correct.

2 Switch off the Astra 200.

3 Start the Astra 200 while keeping the keydepressed. This will run the program BIOS to update FLASH.

4 The BIOS access key is then requested

(Press and then ) to prevent any user from

being able to access by mistake.

5 Copy the new file provided by SDI containing theupdate (DMFlash.tsk) to the \FIRMWARE directory of theapplication (AstraPro).

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


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7 Access the Configuration - Utilities - Update Flash optionA dialog box will open where the update key ( provided bySDI if it is an option update) must be entered.

8 The new program will be transmitted. The process maytake up to 10 minutes, depending on the PC.

9 Switch off the Astra 200.


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3.0 PERFORMING SPIROMETRY

Before testing patients, it is important to keep in mind thatspirometry is an effort-dependent test requiring the completecooperation of the patient. In order to achieve this, you asthe coach play a critical role.

Be sure the patient is comfortable. Make note as towhether the patient is seated or standing, becausesubsequent testing of that patient should be performed fromthat same position. If the patient is standing, have a chairbehind him in the event that he becomes lightheaded afterthe blow. It is generally a good idea to have the elderlyseated for spirometry testing. If the patient is wearing a shirtor blouse with a tight-fitting collar, have him unbutton thetop button and if wearing a tie, it should be loosened. Ifwearing dentures that are loose, it may be necessary tohave the patient remove them.

Explain clearly and in simple terms that they will beperforming a “breathing evaluation”. Try to avoid the word“test” since this has connotations of passing or failing andmay make the patients apprehensive. Point out that they willbe taking a slow maximal inhalation followed by a maximalexhalation, but that the exhalation will be “blasting out” thebreath as fast as they can and as hard as they can. Keythem that you will be coaching them to continue to blow outfor a minimum of six seconds. Assure them that it is quitenormal to blow out for that period of time. The AmericanThoracic Society in their 1994 Standardization of SpirometryUpdate highly recommends that a six second blow be thegoal for all spirometry testing.1

To ensure that the patients take an adequate deepbreath, it is valuable to emulate exactly what you expect. Agood way to do this is through one of the filters. Prior toyour demonstrating the maneuver, tell your patient to beespecially aware of the latter portion of the blow when youare “squeezing out” the last bit of air. If the patient has avisual cue as to what a “big deep breath” is and can actually


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see and hear a forced expiration, they are more apt toperform 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 thepatient slowly makes a maximal inspiration, the first phase ofthe test, loudly exhort the patient to BLAST out. Thiselement of surprise will help the patient to realize themaximum peak flow, which is the second phase of the test.

The third phase of the test, which involves diminishedflow, is important to achieve the highest possible volume ofpatient FVC. Traditionally, technicians have loudly instructedthe patient to “blow, blow, blow…keep going, keep going!” toachieve the maximal forced volume, when the oppositeapproach may actually be more effective.

Evidence suggests that using the “soft sell” may bebetter for achieving the best performance during the thirdphase. “Draw [the patient’s] attention to the …audio tone ofthe flow-sensing spirometers, which shows that he or she iscontinuing to get out some air.” “Patients should be quietlytold to ‘keep going; I can see you’re still getting more airout.’”2 This is a critical part of the test, since an obstructedpatient may actually still be expelling a volume of air, but itmay not seem apparent, and many times the test is stoppedtoo soon. This results in a lower FVC than normal and wheninterpreted, may suggest that the patient is restricted. YourSDI spirometer is designed to give you an audible “beep”when flow has reached a specific diminished threshold. Thespirometer will also alert you with an error message when itsees an abrupt cessation of flow. Another key indicatormight be to note the FET (Forced Expiratory Time) that issometimes displayed as part of the data. If the time wasappreciably shorter than six seconds, this would suggest thatthe patient ended the test too quickly.

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

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


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4.0 LIMITED WARRANTY CONDITIONS

This SDI product together with its standard accessories isguaranteed for a period of ONE YEAR from the date of purchase. Inthe case of any warranty claims the relevant sales invoice (oranother proof of purchase document) must be submitted to SDI.

The instrument must be checked at the time of purchase and anyclaims must be made immediately in writing to SDI.

This warranty covers the repair or the replacement (at the discretionof the manufacturer) of the product or defective parts.

All batteries and other consumable parts are specifically excludedfrom 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 inthe country of installation.

• If the product is utilized differently from the use described in the UsersManual.

• If any alteration, adjustment, modification or repair has been carriedout by personnel not authorized by SDI.

• Problems caused by lack of or incorrect routine maintenance of themachine.

• If the machine has been dropped, damaged or subjected to physicalor electrical stress.

• If the fault is caused by the power source or by another product towhich 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 transportand customs charges for delivery of the goods both to and fromSDI.

Any instrument or accessory returned must be accompanied by aclear and detailed explanation of the defect or problem found.Written or verbal permission must be received before anyinstruments are returned to SDI.SDI reserves the right to modify the instrument if required, and adescription of any modification made will be sent along with thereturned goods.



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Spiro

metry In

dica

tion

s

Spirometry Indications

Dyspnea (shortness of breath)Exercise-induced coughingChest tightnessSmokers over 45 years of age (NLHEP recommendation)ObesityPre-operative testingOccupational exposure to dust and/or chemicalsOngoing assessment of patients receiving bronchodilator treatmentsDetermination and/or documentation of pulmonary disabilityAsthma diagnosisPre-existing pulmonary diseaseFrequent coldsAssessment of congestive heart failure

Although the early detection of COPD is perhaps the most importantindication for application of office spirometry, there are many othersthat have proven to be helped in the diagnosis of disease.

Documents

Astra 200 Users Manual