Micro Medical MicroLab Spirometry User Manual Rev 1.4 August 2004

CONTENTS Introduction

page 3

Package Contents

page 5

Section 1 - User Customisation System Spirometry Airways resistance Calibrate flow transducer Calibrate Rint transducer

page 6 page 11 page 14 page 16 page 18

Section 2 - Operation Main Menu Run test New patient Select patient Modify patient details Review results

page 22 page 23 page 23 page 24 page 25 page 26

Spirometry Relaxed vital capacity Forced vital capacity Report menu Post medication test Display results Save results Print results End Examination

page 27 page 27 page 28 page 31 page 32 page 32 page 35 page 35 page 38

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Airways resistance Report menu Post bronchodilator/steroid test Display results Save results Print results End examination

page 39 page 45 page 46 page 46 page 46 page 47 page 48

PC connection using SPIDA

page 49

Charging Procedure

page 49

Battery Management

page 50

Looking after the MicroLab

page 50

Cleaning the Transducer

page 51

Servicing

page 51

Symbols

page 52

Environment

page 52

Electrical classification

page 52

Consumables / supporting products

page 53

Training

page 54

Specifications

page 55

References

page 57

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Introduction The MicroLab is part of a new range of respiratory instrumentation with the most comprehensive range of features to be found in spirometers of their size and price. The MicroLab is capable of performing spirometry, with or without tidal breathing before the forced manoeuvre and airways resistance measurements. It is fully portable and can be operated directly from the mains power or from the integral rechargeable NiMH battery pack. The MicroLab uses the Micro Medical Digital Volume Transducer, an extremely stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test. The MicroLab has many advanced features including a high resolution graphic display giving real time respiratory traces, user customisation of instrument functions, predicted values, patient database, and the ability to carry out pre and post bronchodilator and post steroid testing. The MicroLab may also be used with the MicroRint transducer to perform airways resistance measurements by the interrupter method. The MicroLab can be used to make and record a minimum of 1000 complete respiratory tests, depending on type. The recorded tests can be uploaded to a computer or printed by direct connection to a printer. To upload to a computer the unit is connected with the serial lead provided using SPIDA spirometry software. SPIDA is a fully Windows™ compatible spirometry system that can interface to the spirometer in either of two ways. Firstly, tests recorded with the spirometer can be uploaded to SPIDA and appended to the integral database, for subsequent storage and analysis. Secondly, live spirometry may be performed with the instrument connected to a computer running SPIDA. In this case MicroLab becomes a powerful respiratory laboratory tool with many display options including powerful reporting and database facilities. Stored data may be printed to the integral thermal printer or to an external printer using the serial to parallel interface Cat. No. MLA350. 3

The manual is divided into two sections. The first section deals with the customisation of the instrument functions and the second with the operation. It is highly recommended that the MicroLab be configured prior to use, as many of the MicroLab’s functions can be customised by the user to suit their own requirements. The defaults set by the user are stored permanently in the spirometer and will remain unchanged until customisation is repeated. Thereafter, the user may refer to the second section only.

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Package Contents The MicroLab is packaged in a sturdy carrying case containing this manual and the following items (Fig.1): 1. MicroLab microcomputer unit with graphic display 2. Micro Medical Digital Volume Transducer 3. Transducer housing. 4. AC Adapter (Cat. No. PSU7800) Together with mains supply lead and disposable cardboard mouthpieces. (SPIDA 5 software is available separately)

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Fig. 1

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Section 1 - User Customisation To customise the MicroLab hold down the enter key, turn the unit on, and then release the enter key after the display goes blank. The following screen will then be displayed:

Customisation 1 System 2 Spirometry 3 Airways resistance 4 Calibrate flow transducer 5 Calibrate Rint transducer 6 Exit

Memory 99% Free

28-02-02 12:30

Customisation option 1: System When this option is selected the following will be displayed: From this menu system settings Customisation such as date format and language 1 System settings 2 Select tests may be changed, the required 3 Clear records 4 Delete patients tests may be selected, records may 5 Delete old records 6 Refresh patient order be cleared from memory, and a 7 User name user name may be entered. 8 System information 9 Exit Memory 99% Free

28-02-02 12:38

System Customisation option 1: System settings When the system settings option is selected the following will be System Customisation Language English displayed: Height units centimeters Weight units kilograms The current settings are shown on Race entry On Sort order Identity the right hand side with an arrow Date format DD/MM/YY Date separator pointing to the active entry. The Date 28-02-02 Time 16:10 active entry may be changed by Dyspnea score On pressing F1, in the case of multiple Change Done selections, or by using the delete and numeral keys, in the case of date and time entry. The arrow may be moved by using the up and down cursor keys.

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Language – A choice of up to seven languages will be available depending upon national preferences. Height units - The patient’s height may be entered in centimetres or inches. Weight units - The patient’s weight may be entered in kilograms or pounds. Race entry - The racial origin and correction factor, entered with the patient details, may be disabled using this option. Sort order - When selecting a patient from the database the list may be displayed in order of first name, last name or patient identity number. Date format - The date format may be selected as DD/MM/YY, MM/DD/YY, or YY/MM/DD. Date separator - The date separator may be selected as - . or / Using these options, dates may be represented as 13-08-01, 13.08.01 or 13/08/01. Date - The current date may be entered when this setting is active. If correction is required, first use the delete key to remove the previous setting and then type the correct date using the numeral keys. Time - The current time is displayed and may be corrected as follows. First use the delete key to remove the previous setting and then type the correct time using the numeral keys. The main rechargeable battery powers the internal clock. In normal use this battery is continuously monitored and the unit will display a warning and turn off automatically before the battery becomes completely discharged. If, however, the unit is left unused for several weeks the internal battery may become completely discharged and the clock will need adjusting once the battery is recharged. Dyspnea score – A dyspnea score, entered with the patient details, may be disabled using this option. Printer - The option to use either the integral thermal printer or external Canon or Hewlett Packard printers. Sound - Select either : Off, High, Medium or Low pitch 7

Please note. If using an external printer, connect the MicroLab to the printer whilst both are switched off. The MicroLab must be connected to the specified printer with a serial to parallel converter Cat No. MLA 350. With both units switched off connect the round Mini-Din plug on the serial cable to the socket in the left hand side of the MicroLab. Connect the 25 way D connector to the serial to parallel converter and plug the converter into the printer Centronics type socket. Serial cable Pt No. CAB3217

Printer

Serial to parallel converter

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It is recommended that whilst printing the batteries are on charge with the unit connected to the mains adapter as more power is required to drive the serial to parallel converter. NOTE: Keep the printer out of reach of the patient when connected to MicroLab.

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System Customisation option 2: Select tests When this option is selected the Select Tests following will be displayed: Spirometry: On The MicroLab is capable of Airways resistance: On performing two types of respiratory function test. It is recommended that only the required tests be activated to Change Done reduce the selections required during operation. The spirometry test may be performed with a single forced expiration and inspiration or with tidal breathing prior to the forced manoeuvre. Please note that the airways resistance test may only be performed using a MicroRint transducer. Use the up and down cursor keys to move the arrow to the required test and then use F1 to turn the test on or off. System Customisation option 3: Clear records This option is used to remove all patient records from memory. A warning will be displayed when selected to avoid the possibility of accidental erasure. An individual patient’s records may be deleted when a patient is selected during normal operation – see Operation, page 25 System Customisation option 4: Delete patients This option will delete all patients from the database who have no test results stored. System Customisation option 5: Delete old records. This option will delete all old records. The period, from 3 to 36 months, for which records must be kept is specified when this option is used. System Customisation option 6: Refresh patient order In some circumstances the order of the patients in the database may become disarrayed. This will be evident when the patients are listed in incorrect order when selecting a patient from the database, listed by name. 9

Using this option will correct the patients’ name order. System Customisation option 7: User name A two-line hospital or surgery name may be entered and will System Customisation appear on the heading of the Enter heading (two lines): 1 printed report. The lines may be 2 up to 30 characters long each. When this option is selected the following will be displayed: Use the num keys to type letter Type the required name using the Caps Done keypad. The numerals 2 to 9 are ascribed letters of the alphabet in groups. For example, 2 is ascribed the System Customisation letters a, b, c, 2 and when pressed Enter heading (two lines): the following will be displayed: 1 a Pressing 2 again will change the 2 letter to the next one on the list at the bottom of the screen. Use the abc2 F1 key to change from lower to Caps Done upper case. To type the next letter simply press the key with the required letter and the cursor will automatically move one place to the right. If the next letter is on the same key then wait for two seconds and the cursor will move to the right automatically. If a mistake is made then use the delete key to go back. To insert a space in the text use the right arrow key. Continue until the required name is complete and then press enter. The second line may now be entered in the same way. Use the numeral keys together with the delete key to correct any mistakes and press F4 when complete. The display will then return to the system customisation menu. System Customisation option 8: System information – issue status shown on either the display or as a print option.

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Customisation option 2: Spirometry When this option is selected the Spirometry Setup following will be displayed: 1 Configuration From this menu the spirometry 2 Indices Selection 3 Exit settings such as peak flow units and display default may be changed, and the required indices to be displayed and printed may 28-02-02 12:25 be selected. Spirometry customisation option 1: Configuration When this option is selected the Spirometry Configuration following will be displayed: Flow units L/min Interpretation Enright The current settings are shown on Predicted curve on Predicted values ECCS the right hand side with an arrow Display default Full Flow/Vol 2nd printed page Off pointing to the active entry. Best criteria Indiviual best Pressing F1 will change the active entry. Change Done The arrow may be moved by using the up and down cursor keys. Flow Units - This option is used to change the displayed units of peak expiratory flow from litres per minute (L/min) to litres per second (L/sec). Interpretation The interpretation displayed at the end of a spirometry test may be set to Enright2, BTS3, NICE 6 or ‘none’. Predicted curve - The dashed predicted curve and dotted baseline curve (displayed when performing a post-bronchodilator test) may be configured to appear as default using this option. However, regardless of default setting, they may be turned on and off during a spirometry test by using the up and down arrow keys. Predicted values - Up to five sets of predicted values will be available depending upon national preferences. 11

Note: If Roca (Spanish) predicted values are selected, then a weight entry will appear, and must be entered, on the patient details screen. Display default - During a spirometry test the display can be set to show the full flow/volume curve (Full Flow/vol), the expiratory part of the flow/volume curve (flow/vol), the volume/time (Vol/time) graphs, or the child incentive as the default. In either case the display can be changed after a spirometry manoeuvre has been performed by using the left and right arrow keys. 2nd printed page - There are four settings for this option which control the content of a full report: Off - a single page report showing all the results together with the Flow/volume and Volume/time curves will be produced. Flow/vol - a two page report will be produced with the second page giving a large Flow/volume loop exceeding ATS recommendations. Vol/time - a two page report with a large Volume/time curve exceeding ATS recommendations. Both - a two page report giving both Flow/volume and Volume/time curves to ATS recommendations. Best test criterion - The criterion for the automatic selection of the best manoeuvre from a series of spirometry tests may be selected. The options are maximum FEV1, FVC, PEF, sum of FEV1 and FVC best individual indices. The selected criterion is used to automatically select the best blow when saving, printing or reporting on a series of manoeuvres. If ‘individual best’ is selected then the greatest individual indices from a series of manoeuvres are selected except the indices derived from the flow/volume loop. These indices (MEF75, MEF50 and MEF25) are measured from the composite flow/volume curve by the method described by ERS – Standardized Lung Function Testing5. The composite curve will then also be used for the printed report. Note: when composite flow/volume curve is used only the expiratory part of the forced manoeuvre is stored and any tidal breathing pattern performed prior to the forced manoeuvre will be lost. 12

The chosen criterion is also used to select for display the best baseline result when a post-bronchodilator manoeuvre is performed. Spirometry customisation option 2: Indices selection The spirometry indices reported and available for printout upon Indices selection (Max 15) VC FEV1/FVC completion of a test may be FEV.75 FEV3/VC FEV1 FEV3/FVC customised using this option: FEV3 FEV.75/FEV6 FEV6 FEV1/FEV6 All indices, apart from FEV1, FVC FVC MEF25 PEF MEF50 and PEF, which are always FEV.75/VC MEF75 displayed and printed, may be FEV.75/FVC MMEF FEV1/VC FEF50/VC turned on or off. Up to 15 Change Done PgDn indices, from a total of 36, may be enabled at one time and will appear on the report screen upon completion of a spirometry test and on the printout. All the indices are stored irrespective of those selected and can be retrieved by changing the selection except for dyspnea score, which will only be stored if the patient’s dyspnea score is stored with the patient’s details. Use the up and down arrow keys to select the required indices and press F1 to toggle on or off. An index will not turn on if 15 have already been selected. Use F3 and F4 to page through the selection screens. Press F2 when all the selections have been completed.

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Customisation option 3: Airways resistance When this option is selected the Airways Resistance Customisation following will be displayed: Set trigger flow 0.00 Use the up and down arrow keys Trigger method Random Operating mode Continuous to select the required option and Number of tests 10 Printout With graphs use the delete and numeral keys Display default Flow/time to enter the trigger flow and F1 to Predicted value Lombardi change the other options. Change Done Press F4 when all the selections have been completed to save your selections and return to the customisation menu. Set Trigger Flow - This option allows the default value of flow at which the occlusion occurs to be set. When selected the following will be displayed: Any value between 0.1 l/s and 1.99 l/s can be entered. If a high value is chosen then it is possible that the unit will never occlude during a test, as the subject may never reach the set flow rate. If a very low value is set then inconsistent values of Rint may be obtained, as the signal may be lost in physiological noise. If zero is entered then the unit will trigger on the peak of the flow curve. The instrument will always occlude using this setting and the signal will be above any noise. The trigger level can also be adjusted from the airways resistance main menu prior to performing a test. Trigger method - This option sets the default for the trigger method, random or user. If random is selected then occlusion of the patients tidal breathing will occur automatically in a random pattern until the required number of tests have been performed. If user is selected then no occlusions will occur until the user initiates a test with a key press. Operating mode - The airways resistance test may be operated in discrete or continuous mode. 14

With discrete mode each occlusions has the associated pressure and flow waveforms displayed immediately after the occlusion. The user may then choose to accept or reject the measurement before proceeding. In continuous mode the flow and pressure waveforms may be reviewed upon completion of the test and spurious results deleted. Number of tests The airways resistance measurement is taken as the median of the results obtained from a number of occlusions up to a maximum of 15. The maximum number of occlusions per test may be set using this option. Printout - The printed report will contain summary results of all the occlusions occurring during a test. This may be accompanied by the flow/time and pressure /time curves if required. Display default - During a test the display can be set to show the full flow/volume curve (Flow / vol) or the flow/time graph (Flow / time). In either case the display can be changed after during a test by using the left and right arrow keys. Predicted value – Lombardi, Eiser or Merkus predicted values may be selected.

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Customisation option 4: Calibrate flow transducer The MicroLab is calibrated to read volumes in litres at body temperature, barometric pressure saturated with water vapour (BTPS). The calibration should remain stable indefinitely, unless the transducer is physically damaged, and the unit Calibration check should not require re-calibration. However, as a check on the 1 Check calibration correct functioning of the unit we 2 Print report 3 Enter calibration values do recommend that the 4 Exit calibration be checked periodically. 28-02-02 14:34 When this option is selected the following options will be displayed:

Check calibration – press 1 to check the calibration and the following will be displayed: To check the calibration of the MicroLab a large syringe should preferably be used with a 30mm outlet. A 3 Litre Syringe is available from Micro Medical as Cat. No. SMI2125. The MicroLab transducer should be connected to this syringe with the minimum of adapters. Type in the syringe volume and then press enter and the display will change to:

Calibration check Syringe volume (1 to 3 litres) = 3

Type the syringe volume and then press enter

Empty and fill syringe 10

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With the syringe connected press 1 Reject a key and empty the syringe 10 L/s 2 Accept 8 evenly, without pausing, and avoid 6 banging the syringe against the 4 2 end stop. Once emptied, 0 1 2 3 4 5L -2 immediately reverse the procedure -4 and fill the syringe to obtain both -6 -8 expiratory and inspiratory calibrations. If the syringe was not emptied smoothly and without banging against the end stop, press 1 to reject the calibration and repeat the procedure. When a satisfactory manoeuvre has been performed press 2 to accept. Upon completion, the inspiratory Calibration check and expiratory calibration errors will be displayed. If the calibration Expiratory calibration: -4.8% Inspiratory calibration: -5.6% error is greater than 3%, in either WARNING: large error detected, direction, then the following refer to instruction manual warning will be displayed: If the calibration error was Accept Reject negative, check the syringe for leaks and the flow transducer for free rotation of the vane. If a fault is found then press F4 to reject the calibration. Once the calibration check has been successfully completed press F1 and the new calibration values will be stored. Print report – Press enter to start printing or ESC to cancel. A calibration report giving details of the last calibration check will be produced. Calibration values - This option is only used when a replacement flow transducer is supplied by Micro Medical with ATS calibration factors.

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Customisation option 5: Calibrate Rint transducer The Rint value is calculated from the measurements of flow, prior to occlusion, and the pressure during occlusion. Both flow and pressure can be independently calibrated. Flow is measured using the pressure differential across a stainless steel resistive element. A high fidelity, high frequency, pressure transducer is used with a long-term drift of +/- 0.5% per annum. It is only necessary, therefore, to perform the pressure calibration yearly. Micro Medical can supply a pressure calibration kit (Cat No. CAL6000). The stability of the flow calibration depends on the pressure transducer and on the characteristics of the resistive element. These characteristics will remain stable for at least 50 tests as long as no physical Calibration check damage has occurred and that the 1 - Flow (Exp 10/09/01 Ins 10/09/01) 2 - Pressure (10/09/01) disposable filter is always used. 3 - Print report 4 - Factory calibration When calibration is selected the 5 - Exit following options will be displayed together with the dates of the last Select the required option calibrations:

Option 1 - Calibrate flow When this option is selected the display will show: Type the syringe volume and then press enter.

Calibration check Syringe volume: _

L

( 1 to 3 litres )

Type the syringe volume and then press enter

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A zero flow reading of the transducer will now be taken: Connect the syringe to the Rint Calibration check transducer, using the respiratory Connect the syringe to the transducer. A zero flow reading will now bw taken. filter, and withdraw the syringe Ensure that there is no flow through the transducer when enter is pressed. handle fully. Ensure that there is no flow through the transducer, when enter is pressed.

The display will then show a graph of the flow generated when the syringe is emptied: Try to keep the flow within the dotted lines. Once emptied, immediately reverse the procedure and fill the syringe to obtain both expiratory and inspiratory calibrations.

Empty and fill syringe

If the calibration drift is greater than 3%, in either direction, then the option to store the new value will appear: If the syringe is emptied too quickly then an error message indicating that the flow was too high is displayed and the procedure should be repeated with a lower flow.

Calibration check Calibration error: +3.5% 1 - Store new value 2 - Exit

Select the required option

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