EasyOne Operators Manual Rev V71

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1 Introduction Thank you for choosing the EasyOneTM Spirometer. With EasyOneTM you have chosen a high quality spirometer that minimizes the need for maintenance due to its unique ultrasound technology. EasyOneTM does not need calibration and remains consistently accurate over years. The spiretteTM breathing tube assures perfectly hygienic conditions for every patient at low cost even if the spirometer is frequently used. The EasyOneTM Diagnostic Spirometer has two operating modes for you to choose from: In the Diagnostic mode, EasyOneTM offers you extensive and diverse options for spirometric tests in accordance with the standards of the European Respiratory Society (ERS) and the American Thoracic Society (ATS). In the Frontline mode, EasyOneTM offers you the option of greatly simplified spirometric measurement. In the NLHEP mode, the EasyOneTM fulfills all requirements of the National Lung Health Education Program (NLHEP [4]). This mode is a little more restrictive than the Frontline Mode (only FEV6 maneuvers). The EasyOne Frontline Spirometer only offers the Frontline and NLHEP mode. The differences between the two operating modes are described in the table that follows. Diagnostic mode

Frontline and NLHEP mode

Test modes

FVC (expiratory), F/V Loop (inspiratory and expiratory), slow VC, MVV, PrePost measurement US: Unit can be configured to meet NIOSH/OSHA and Disability reporting requirements.

FVC (expiratory), Pre-Post measurement

Parameters

FEV1, FVC, FEV1/FVC, FEV6, FEV1/FEV6, MEF25-75, MEF25, MEF50, MEF75, PEF, FET, FIVC, PIF, IVC, IRV, ERV, FEV1/VC, MVV, pre-post % variation, QC rating

FEV1, FEV6, FEV1/FEV6, FVC, FEV1/FVC, PEF, pre-post % variation, QC rating NLHEP mode: only FEV6, no PEF display

Quality control

Requires 3 acceptable, reproducible maneuvers. Details in Chapter 10.1.

Requires 2 acceptable, reproducible maneuvers. Details in Chapter 10

Automatic quality control

Quality control can also be overridden manually.

Automatic control is always active

Trial storage and display

Can store and display the best, or the best 3 trials, including curves.

Stores and displays only the best trial and curve

Report Configuration

Report can be customized for curve type and size.

Report is fixed, showing the smaller sized FV and VT curves

The default setting of the EasyOneTM Spirometer is the Diagnostic Mode. To switch the EasyOneTM into the Frontline Mode, see Chapter 8 under “General Settings”. The EasyOne-line Spirometer does not contain the EasyOneTM cradle. Instead it contains the EasyOneTM Screen Connector in conjunction with the EasyWare software for the PC. The screen connector can be used to display real time curves on the PC Screen, it can however not be used for direct connection of EasyOneTM to a printer. The EasyWare manual describes installation and use of the PC software.

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2 Warning Information The following terms are used as follows in this document: Caution:

Possibility of injury or serious damage

Please note:

Important information for avoiding damage to the instrument or facilitating operation of the instrument

Please note the following information on safe operation of the EasyOneTM spirometer:

means: Read the Operator’s Manual.

Caution:

The instrument is not suitable for use in the presence of explosive or flammable gases.

Caution:

Connect only printers and computers that comply with IEC/EN 60950-1 Standards, or that bear the UL or CSA mark.

Caution:

For AA batteries, do not attempt to charge, connect improperly, or dispose of in fire as there is possibility of leakage or explosion. Follow manufacturer’s recommendation for proper disposal.

Caution:

Calibration and servicing may be carried out only by ndd staff. Do not open the instrument.

Caution:

Pulmonary function tests require maximum effort on the part of the patient and may lead to sensations of dizziness or giddiness.

Caution:

Do not use the device while it is sitting in the Cradle.

Please note:

Use only alkaline batteries, and remove the batteries from the battery compartment if you intend not to use the instrument for a long period.

Please note:

The direct printing option from EasyOneTM supports only a limited set of printers. Please visit the ndd web site www.ndd.ch in order to get the most recent list of supported printers.

Please note:

The product you have purchased should not be disposed of as unsorted municipal waste. Please utilize your local WEEE collection facilities in the disposition of this product and otherwise all applicable requirements.

Please note:

Use only authentic ndd disposables to assure accuracy, long-life and full warranty coverage.

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3 Intended Use The ndd EasyOneTM is designed for conducting simple spirometric measurements on adults and children over the age of 4 by general practitioners, specialists, in occupational medicine and in hospitals. The EasyOneTM spirometer is used together with the spiretteTM respiratory tube in order to conduct slow and forced spirometric maneuvers and MVV tests.

4 Instrument Installation In case of the EasyOne-line spirometer, please refer to the EasyWare manual for installation and use of the PC software. 4.1

Setting Up the Instrument

The EasyOneTM spirometer is delivered with USB cradle, 2 AA batteries, a USB cable, 4 spiretteTM breathing tubes and a Quickstart CD. The following picture shows the spirometer in combination with a printer.

The following picture shows the parts supplied with the EasyOne-line. It additionally includes the EasyWare PC software and the screen connector instead of the USB cradle.

Install the two AA alkaline batteries (included) in the compartment on the rear of the spirometer, taking care to match the polarity marking on the batteries with the markings inside the battery compartment.

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Caution:

Do not attempt to charge or burn the AA batteries used in the instrument. Please follow the manufacturer's instructions on battery disposal.

Please note:

Use only alkaline batteries, and remove the batteries from the battery compartment if you intend not to use the instrument for a long period.

Please note:

A low battery message will alert you when battery power falls below 10%. Data saved in memory is not lost when battery power is low, or when batteries are removed.

Install the spiretteTM as shown. Be sure to orient the spirette TM so that the arrow on the spiretteTM lines up with the arrow on the spirometer. Push the spiretteTM all the way in to the stop. For maximum hygiene, consider tearing the spiretteTM bag from the bottom, leaving the spiretteTM partially wrapped during insertion and until the spirometer is handed to the patient. The spiretteTM is easily removed by pushing it up from the bottom. Please note:

Use only authentic ndd disposables to assure accuracy, long-life, and full warranty coverage.

If you wish to export data to a PC, or print reports via the PC, connect the EasyOneTM base unit to a PC using the USB cable. EasyWare or EasyWare Lite must be installed on the PC. If you wish to print reports using a printer with PictBridge, then connect the EasyOneTM base unit to the printer using the USB cable. The PictBridge port is normally located on the front side of the printer.

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If you wish to print reports using direct printing, then connect the EasyOneTM base unit to the printer using the USB cable ( in this case the USB port is normally located on the back side of the printer). Please note that only a very limited number of printers support this printing option.

The following picture shows how the EasyOneTM Screen Connector is used:

Caution:

Connect only printers and computers that comply with IEC 60950-1 Standards.

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Setting Language, Date, Time, Altitude (above sea level) and Printer Type

Press the (ON/OFF) key for at least 2 seconds in order to switch on the instrument. The instrument switches off automatically if no key is pressed for 15 minutes. If you are switching on the instrument for the first time, you will be prompted to choose a region, the language and to enter the date, time, altitude above sea level and approximate relative humidity at the instrument's location. This data is not pre-set. If you intend to print reports, you can also select the right printer type on the instrument. The spirometer is delivered with the pre-set default settings. Please refer to Chapter 8 of this User Manual for the procedure for changing the settings. Adapting the settings to your needs allows you to get the most out of your EasyOneTM instrument. After you have made the above settings when switching on the instrument for the first time, you can then change any settings at any time using the CONFIGURATION menu item from the main menu. 4.3

Operating the Keys

(ON/OFF) (ENTER) (<) (>) (0,ESC)

(2,abc), etc.

Please note:

This switches EasyOneTM on or off. Press and hold the key (for at least 2 sec.) until you hear an audible signal. This confirms data entry or the selection and moves you to the next entry field. Deletes last character, scrolls to the left or up. Scrolls to the right or down Press the key briefly in order to enter (0), keep the key pressed longer (at least 1 sec.) in order to return to the previous field with (ESC) or abort the operation, press the key briefly twice in order to enter a blank (the key function operates only if letters can be entered). Press the key briefly in order to enter the digit "2", press the key briefly in order to enter "A" (the key function operates only if letters can be entered), press the key briefly twice in order to enter "B" (the key function operates only if letters can be entered), if you press the same key quickly several times consecutively, you will scroll first to the upper-case letters, then to the number and then to the lower-case letters, umlauts and special characters can be found on key (1). The escape key (Esc-0) is particularly helpful and important in unit navigation. The escape function requires the key to be pressed and held momentarily. Escape is useful for moving to previous menus, items, or fields, and escaping a spirometry test. Pressing this key rapidly in fields where letters are possible, such as patient name and report header, allows the entry of a blank space or a zero.

5 Performing Spirometry 5.1

Preparing the Patient

Prepare for testing by having the patient loosen tight clothing, remove dentures, and relax. The patient may sit or stand. If standing you may want to perform testing in an area free of sharp table or counter edges, or have a chair handy as there is a slight possibility that the patient could faint during the strenuous spirometry maneuver. Explain that the purpose of the test is to determine how much air a person’s lungs can hold and how quickly that air can be expelled with a forceful, maximal effort. Since the spirometry test requires active

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participation by the patient it is very important to demonstrate the maneuver for the patient. Emphasize the essential elements of the test: · filling lungs completely · sealing lips around the spiretteTM so that there are no leaks, taking care not to block its opening with teeth or tongue or bite down excessively · blasting out as hard and fast as possible · continue blowing out until the lungs are completely empty If you are new to spirometry, you should practice testing yourself and others prior to testing patients. You will learn to recognize a poor effort by observing the patient and/or interpreting the Quality Messages displayed by the spirometer after each effort. After a poor effort you must explain what went wrong. Develop enthusiastic coaching techniques to use during the maneuver to maximize your chances of getting quality results with a minimum number of efforts. Caution:

5.2

Pulmonary function tests require maximum effort on the part of the patient and may lead to dizziness or giddiness.

Measuring the Forced Vital Capacity (FVC)

· Choose “Perform Test” in the main menu and then NEW. Confirm with ENTER. The instrument will now allow you to enter the patient data. · Enter the corresponding patient data line by line. Use the keys as described in Chapter 4.3. Confirm with ENTER each time. · After entering the patient data, you then move on to the "Test selection" menu. Choose the FVC test and confirm with ENTER. · Insert a spiretteTM into the instrument. Ensure that the arrow on the spiretteTM is lined up with the arrow on the instrument. · Once again briefly prepare the patient for the test. When the patient is ready, press ENTER. You will now hear the sensor buzzing. · The instrument now prompts you to avoid air flow in the spiretteTM since it is setting the baseline. It is advisable to block off the spiretteTM on one end in order to ensure that the baseline is set precisely even if the room is draughty. An audible signal will sound when the baseline has been set. You will see prompt "Blast out" on the screen. · Hand the instrument to the patient. Ask the patient to breathe in deeply, insert the spiretteTM correctly into his or her mouth. Now ask the patient to exhale as firmly and as quickly as possible, and continue exhaling until all air has been exhaled. · At the end of the maneuver, you will see a message on the display indicating whether the maneuver was acceptable. At least three acceptable maneuvers must have been performed before you see message "Session complete". · Using keys (>) and (<), you can view the result on the screen. In order to print the result, choose the PRINT field and press ENTER. Then place the instrument into the base unit. The report is then printed. If you want to get back to the main menu at any time, press and hold the escape key (esc-0) for 1 second. Repeat this until you reach the main menu.

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You can conduct the following tests with EasyOneTM: FVC (expiratory), FVL (inspiratory and expiratory), Tidal FVL, pre/post tests, slow spirometry and MVV. Please also see Chapter 9. There are also protocols that ensure that testing complies with the guidelines for NIOSH/OSHA/Cotton Dust and Social Security Administration Disability evaluations. 5.3

Checking the Test Quality

In order to assess the pulmonary function of the patient, it is necessary to obtain acceptable test quality. The test quality depends on co-operation of the patient and this, in turn, depends on the quality of the physician's instructions. Consequently, EasyOneTM incorporates an automatic quality control function with prompts to facilitate the physician's job of providing the patient with good instructions. After each maneuver, a message on the screen will inform you as to whether the maneuver was acceptable or not. If not, the message will guide you on how to coach the patient to do better. A quality grading from A to F is displayed at the end of the test. It provides information on the overall quality of the test. Please refer to Chapter 10.2. for further information on the quality grades. The table below gives you the possible prompts that EasyOneTM provides you with after a maneuver: Only one of the above prompts is shown after a maneuver. As soon as you see message "Session complete", you need not conduct further maneuvers. If, even after repeated attempts, it is not possible to obtain an adequate number of good maneuvers, you should take a break, depending on how the patient feels or stop measurement. Even after a break, the measurement is stored and can be printed out under “Print results” in the main menu. You also have the option of adding tests subsequently. Read more on this in Chapter 9.6. 5.4

Interpreting Results

When interpreting the results, it is important to allow for the quality rating of the test. The quality ratings A to C indicate a reliable result. A quality rating between D and F indicates insufficient test quality. The result must then be interpreted with caution. As soon as you obtain the message "Test complete" after conducting a test, you can either print out the report immediately with ENTER or select the DATA field and view the result on the display. On the printed report, parameters that are below the lower limit of normal (LLN) are printed in red and marked with an asterisk (*). EasyOneTM also offers an automatic interpretation aid. Please refer to Chapter 11 for further information on this interpretation. It is possible to deactivate both the QC-Grade function and the Interpretation function.

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Printing a Report

You will require a base unit and a compatible printer in order to print a report directly from EasyOneTM. With base unit or Screen Connector reports can also be printed via a PC using the software EasyWare. The type of printing and additional print option can be set in the Printer Settings of the CONFIGURATION menu (see chapter 8.3). Immediately after completion of the test, you have the option of printing by selecting the PRINT field and confirming this with ENTER. You will see message "Please connect device to cradle". Insert the instrument into the cradle and wait until the print job has been printed. EasyOneTM issues an audible signal indicating when the instrument can be removed. You can also print old tests. To do this, select option ”Print Results”, “Single Test” in the main menu, choose the required test with key (>) or (<) and press ENTER. You can also print a number of tests at once by choosing “Print Results”, “Range of Tests” and entering a start and end date. You will once again see message "Please connect device to cradle ". Depending on the type of printer, it will take between 30 and 90 seconds to print out the report. Should you have problems printing out, please refer to the information in Chapter 15. During PictBridge printing the following 4 icon groups show the status of the printing process: Printer Activity Printing

Job End Status Not ended

Error Type No error

Error reason No reason / No error

Idle

Ended normally

Warning

Check paper supply

Paused

Aborted

Fatal error

Check ink cartridges

Other reason

General printer problem Printer cannot read report file

5.6

Saving and Retrieving Measurements

EasyOneTM saves all test results automatically. No data is lost even if the batteries are removed. The oldest test is overwritten when the memory is full (up to 700 measurements). You can recall saved measurements for the purpose of conducting a new test with the same patient, adding maneuvers, adding a post-test, viewing results, or printing results. You can add a maneuver or a post-test only on the same day that the original test was performed. See Chapters 9.5 and 9.6. In order to add a test to an old measurement, choose “Perform Test” in the main menu and then choose RECALL. Follow the rest of the instructions. In order to view an old test, choose “View Results” in the main menu and choose the desired test. 5.7

Quick Test

You have the option to perform a quick test without entering patient data. Select “Perform Test” in the main menu and then QUICK. Choose the desired test using the arrow keys and press ENTER. Please note:

When Quick Test is selected, no comparison to predicted normals are displayed or printed. Predicted normals are only available when age, height and gender are entered.

It is possible to enter patient data after having performed a quick test. Proceed as described in Chapter 5.8. Once patient data is entered predicted normals will be displayed and printed.

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Editing Patient Data

You have the option of editing or adding patient data after a test has been performed. To do this, choose “Edit Database” in the main menu and press ENTER. Choose the desired test with keys (<) and (>) and make the changes. Please note:

Editing patient data may influence predicted computation and interpretation of the test result. You should thus recheck the measured result when age, height or gender are changed.

6 Specifications 6.1

EasyOneTM Model 2001 Spirometer

Size: Weight: Measuring accuracy

Measuring range: Resistance: Display: Data entry: Data memory: Test modes 'Diagnostic': Test modes 'Frontline': Parameters 'Diagnostic': Parameters 'Frontline': Respiratory tube: Measurement principle: Predicted:

Power supply: Power consumption: Battery service life: Report: Storage: Operating conditions: Certifications and standards:

Instrument classification:

83 x 158 x 43 millimetres (3.3 x 6.2 x 1.7 inches) 255 grams (9 ounces) Volume: ±2% or 0.050 l Flow: ±2% or 0.020 l/s, (except PEF) PEF: ±5% or 0.200 l/s MVV: ±5% or 5 l/min. Volume: ±12 l Flow: ±16 l/s approx. 0.3 cm H2O/L/s 64 x 160 graphic display 14-key keyboard for up to 700 tests FVC, FVL, Tidal FVL, Slow VC, MVV, Pre/Post (US devices: OSHA, SSA) FVC, Pre/Post FVC, MVV, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FEF75 (MEF25), FEF50 (MEF50), FEF25 (MEF75), MEF25%-75%, PEF, FET, FIVC, PIF, IVC, VC, FEV1/VC, ERV, IRV, pre-post % variation, Lung Age FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, PEF, pre-post % variation, Lung Age Disposable spiretteTM respiratory tube Ultrasound transit-time measurement ERS (ECCS), Roca, Austria, NHANES III, Knudson 1976, Knudson 1983, Crapo, Morris, Cherniak. Optional: Berglund, Gulsvik, Hedenstroem, Asia 1-4, JRS2001, Gore, Pereira, Finnish. Paediatrics: Zapletal, Dockery, Hsu, Polgar. Optional: Hibbert 2 alkaline batteries, type AA, 1.5V 0.6 W approx. 400 tests A4 or 8.5” x 11”, supports PictBridge standard and direct USB printing in conjunction with selected printers. Temperature: -40 to 70 °C, Relative humidity: 0% to95% Ambient pressure: 500 to 1060 hPa Temperature: 0 to 40 °C, Relative humidity: 0% to 95% Ambient pressure: 500 to 1060 hPa CE Declaration of Comformity, see attachment. C CSA US approval, CAN/CSAC22. 2 NO. 601.1-M90, S1-94, CSA 601.1 Amendment 2: 1998, UL Std No. 2601.1, FDA 510 (k) approval, K993921 EasyOneTM meets or exceeds the published targets of the European Respiratory Society (ERS), the American Thoracic Society (ATS) and the National Lung Health Education Program (NLHEP). Type BF applied part Powered internally with (2) AA alkaline batteries Short time operation, less than 10 minutes Instrument not suitable for use in flammable anaesthetic gases in mixtures with O2 or NO.

EasyGuide Life time:

6.2

Page 12 7 years

EasyOneTM Model 2010 Cradle (optional)

Size: Weight: Power supply: Power consumption: Function: Interface:

119 x 173 x 83 millimetres (4.7 x 6.8 x 3.3 inches) 284 grams (10 ounces) From the batteries of the EasyOneTM spirometer or from USB power Type 0.15W Connects the EasyOneTM spirometer to a printer or PC Standard USB type A and B connectors, for connection to PC or printer. Pins: 1 = VBus, 2 = D–, 3 = D+, 4 = GND

Storage: Operating conditions: PC:

6.3

Temperature: -40 to 70 °C, Relative humidity: 0% to 95% Ambient pressure: 500 to 1060 hPa Temperature: 0 to 40 °C, Relative humidity: 0% to 95% Ambient pressure: 500 to 1060 hPa The PC must comply with corresponding IEC standard (ex. IEC 60950-1. The user is responsible that requirements of IEC 60601-1-1 for safety of medical electrical systems are met.

EasyOneTM Model 2010 Screen Connector (optional)

Size: Weight: Power supply: Power consumption: Function: Interface:

64 x 44 x 25 millimetres (2.5 x 1.7 x 1.0 inches) 82 grams (3 ounces) From USB port Type 0.15W Connects the EasyOneTM spirometer to a PC Standard USB type A connector for connection to PC Pins: 1 = VBus, 2 = D–, 3 = D+, 4 = GND

Storage: Operating conditions: PC:

6.4

Temperature: -40 to 70 °C, Relative humidity: 0% to 95% Ambient pressure: 500 to 1060 hPa Temperature: 0 to 40 °C, Relative humidity: 0% to 95% Ambient pressure: 500 to 1060 hPa The PC must comply with corresponding IEC standard (ex. IEC 60950-1. The user is responsible that requirements of IEC 60601-1-1 for safety of medical electrical systems are met.

Accessories

2050-1 2050-5 2050-6 2040-2 2030-2

Please note:

Case of 50 spiretteTM Case of 200 spiretteTM Case of 75 spiretteTM, no wrapping EasyWare USB Calibration Syringe

Use only authentic ndd disposables to assure accuracy, long-life, and full warranty coverage.

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7 Definition of Parameters FVC FIVC FEV1 FEV6 FEV1/FVC FEV1/VC FEV1/FEV6 MEF 25 MEF 50 MEF 75 MEF 25-75 PEF PIF FET PRE/POST% variation LLN BEV VT ERV IRV VC or VCmax VCex VCin IC MVV Lung Age

Forced Vital Capacity (expiratory) Forced Vital Capacity (inspiratory) Forced Expiratory Volume (1 sec). Forced Expiratory Volume (6 sec). Ratio of FEV1 to FVC Ratio of FEV1 to VC taken from SVC test Ratio of FEV1 to FEV6 Mid Expir. Flow at 75% of Vital capacity Mid Expir. Flow at 50% of Vital capacity Mid Expir. Flow at 25% of Vital capacity Mid Expir. Flow at 25%-75% of Vital capacity Peak Expiratory Flow (in l/min or l/sec) Peak Inspiratory Flow Forced Expiratory Time Percentage variation of measured values before and after bronchial spasmolysis Lower Limit of Normal Back Extrapolated Volume Tidal Volume Expiratory Reserve Volume Inspiratory Reserve Volume Maximum Vital Capacity Expiratory Vital Capacity Inspiratory Vital Capacity Inspiratory Capacity Maximum Voluntary Ventilation (per min.) Lung Age, see Chapter 17, (8) for reference

8 System Configuration If you wish to change the instrument setting, please choose the “Configuration” option in the main menu. You will now be in the Configuration menu. The tables below provide an overview of the setting options offered to you by EasyOneTM. Choose the option you require. 8.1

Test Settings

Test settings are not available in NLHEP mode (all options are fixed in this mode). Relates to

Option

Default setting

Predicted

See Specifications

EU: ERS/Zapletal US: NHANES-III

You can select your desired predicted values from the predicted publications listed. US: Frontline only supports NHANES-III

Additional paediatrics

Dockery, Hsu, Polgar, none

None

You have the option of selecting different predicted values for children than those for adults. US: Frontline only supports NHANES-III

Best value selection "ValueSel" (*)

BEST VALUE, BEST TRIAL

EU: BEST TRIAL US: BEST VALUE

In BEST VALUE setting, the relevant, best value from different tests is selected. BEST TRIAL selects the test which has provided the best results (see Chapter 10.3).

Interpretation (*)

NLHEP, GOLD/ Hardie, none

NLHEP

Automatic interpretation (see Chapter 11) is activated or deactivated here.

Description

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Relates to

Option

Default setting

Lung Age (**)

yes, no

No

If set to “yes”, the lung age is displayed on the result screen and printed on the report. Lung Age is only shown if the patient is a smoker. When the calculated lung age is lower than the patient’s actual age, the patient’s actual age is shown..

Automated Test QC (*)

Yes, no

Yes

The automated test QC (see also Chapter 10) is activated and deactivated here.

FVC selection

FVC, FEV6

FVC

FEV6 indicates the exhaled volume after 6 seconds. When set to FEV6, EasyOneTM stops the measurement after 6 seconds. MEF25, MEF50, MEF75 and MEF25-75 are not reported in that setting. When set to FVC, EasyOneTM continues the measurement until end of test criteria are met.

PEF unit

l/s, l/min, OFF

l/s

Peak flow can be specified in litres per minute or in litres per second. OFF: PEF is not shown.

African ethnic corr. (***)

75%-110%

88%

The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group.

Asian ethnic corr.

75%-110%

100%

The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group.

Hispanic ethnic corr. (***)

75%-110%

100%

The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group.

Other ethnic corr.

75%-110%

100%

The predicted value is corrected by this additional factor if the selected predicted publication does not specify a separate calculation for this ethnic group.

Curve storage (*)

all curves, best curve

best curve

When set to ALL EasyOneTM can save up to 8 curves of a test. This is necessary if you want to print the 3 best curves or if you want to export the curve data of each trial. Please note that saving all 8 curves uses substantially more memory.

Description

* Only available in Diagnostic Mode ** Only available in Frontline mode. *** In Frontline US devices not available because NHANES III supports African & Hispanic ethnic groups

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General Settings Default Setting

Relates to

Option

Description

Time format

24 hours, am/pm

EU:24 hours US:AM/PM

Sets the time format for 12 or 24 hour.

Date format

DD.MM.YY, DD/MM/YY, MM/DD/YY

EU:DD.MM. YY US:MM/DD/ YY

Sets the data format.

Current date

Please enter the correct date at this point and confirm with ENTER.

Current time

Please enter the correct time at this point and confirm with ENTER.

Alphanumeric ID

Yes, no

No

If Patient and/or Technician ID also include letters, please set to “Yes”.

Technician ID

Yes, no

No

If you want the technician ID to be saved as well and listed on the report, please choose “Yes”.

Syringe volume

1.0l, 1.5l, ...7.0l

3.0l

Choose the volume of your syringe if you wish to use it to conduct a calibration check.

Height unit

m/cm, ft/inch

EU: m/cm US: ft/in

Choose how the unit will indicate height and altitude.

Weight unit

kg, lbs

EU: kg US: lbs

Choose how the unit will indicate weight.

Age, date of birth

Age, birth

EU: Birth US: Age

If you use a database, consider entering the date of birth so that the age can be calculated correctly at a later point.

Language

German, English, others

English

Choose the desired language.

LCD Contrast

Changes the display contrast.

Op. mode

Diagnostic, Frontline, NLHEP

Diagnostic

see Chapter 1

Temp. unit

°C, °F

EU: °C US: °F

Determines how temperature is reported.

Altitude above sea level

0...4000 m

0 m or ft

Set the altitude above sea level of your location.

Rel. humidity

0...100%

40%

Enter the average relative humidity at your location.

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8.3

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Printer Settings Default setting

Relates to

Option

Description

Printer type

HP b/w, HP color, Canon b/w, Canon color, Epson b/w, Epson color, Canon 300bw, Canon 300col, PictBridge, via PC

HP b&w

Choose the right option to match your available printer. See Chapter 15 if you have problems. Via PC should be entered if you want to print using EasyWare.

Result data

3 best values, best values

best values

You have the choice of printing out only the best test or the 3 best tests on the report.

Number of Curves

3 best curves, best curve

best curve

Choose if you want to print the 3 best curves of the tests or only the best curve. It is only possible to print the 3 best curves if the 3 best curves were saved (see test settings ”Save curve data”).

Graph Types

FV&VT small, FV large, VT large, FV&VT large

FV&VT small

Choose what curves you wish to have on the report.

Header 1-4

Optional entry

Blank

You can enter the name and address of the institution or other information in 4 lines of 40 characters each.

Size

Default, Letter, A4

Letter

PictBridge paper size.

Quality

Default, Normal, Draft

Draft

PictBridge quality. Set to ‘Draft’ in order to improve printing speed.

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9 Test Types When you enter the patient data or select an existing patient, you will see the Test menu with the following selection options: · FVC (expiration) · FVL (inspiration and expiration) · Tidal FVL · MVV · Slow VC It is also possible to add a “Post” test to a FVC or FVL Test. The various measurement methods are outlined below. Good co-operation on the part of the patient is essential with all methods. Consequently, you should explain to the patient clearly beforehand what he or she has to do and motivate the patient to co-operate. Choose the required measurement method with keys (>) or (<) and confirm with ENTER. 9.1

FVC (expiration)

This is the most commonly used spirometric measurement. Prepare the patient as described in Chapter 5.1 before you start the test. Then proceed as follows. · Insert a spiretteTM into the instrument. When doing this, please ensure that the arrow on the spiretteTM is lined up with the arrow on the instrument. · Press ENTER when the patient is ready. You will now hear the sensor buzz. · The instrument prompts you to avoid flow in the spiretteTM while it is setting the baseline. It is necessary to block off the spiretteTM at one end in order to ensure that the baseline is set precisely. An audible signal sounds when the baseline is set. You will see the prompt "Blast out" on the screen. · Hand the instrument to the patient and ask the patient to breath in deeply first, then to insert the spiretteTM correctly into his or her mouth, to exhale as firmly and quickly as possible and to continue exhaling until all the air has been exhaled. · At the end of the maneuver, you will see a message on the screen indicating whether the maneuver was acceptable. At least three acceptable, reproducible maneuvers must be performed before you see message "Session complete". In Frontline mode, only two acceptable, reproducible maneuvers need to be performed. 9.2

FVL (inspiration and expiration)

With this test mode, a deep inhalation follows the exhalation maneuver directly. Proceed in the same way as with the above-described FVC test. However, instruct the patient not to remove the spirette TM from his or her mouth after exhaling, but to follow up with a deep, maximum inhalation. Three acceptable tests should be conducted with this test as well. 9.3

Tidal FVL

In this test mode the patient can do tidal breathing before the full FVL maneuver, as described in Chapter 9.2. When the maneuver is finished press enter to manually stop the trial. This test mode is mainly used with the EasyOne–line setup. 9.4

Slow VC

Slow spirometry serves to determine the vital capacity and the lung volumes (see Chapter 7). You can repeat the maneuver several times. The best test is saved. Proceed as follows: · Insert a spiretteTM into the instrument. Ensure that the arrow on the spiretteTM lines up with the arrow on the instrument. · Press ENTER when the patient is ready. You will now hear the sensor buzz.

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· The instrument now prompts you to avoid flow in the spiretteTM while it is setting the baseline. It is advisable to block off the spiretteTM at one end to ensure the baseline is set precisely. An audible signal sounds when the zero point is set. · The patient must now insert the spiretteTM into his or her mouth and breathe at rest (about 3-5 breaths) until you hear an audible signal. · The patient must then take a deep inspiration followed by a maximum exhalation. · The instrument stops automatically at the end of the maneuver. If you are only interested in the vital capacity without determination of the other volumes (ERV, IRV, VT, IC) the VC maneuver can also be performed without waiting for the acoustic signal. At the end of the SVC test you can decide to immediately add an FVC test. If you do so the parameter FEV1/VC (Tiffeneau) is also shown on the printed report of the FVC test. 9.5

MVV

· Insert a spiretteTM into the instrument. Ensure that the arrow on the spiretteTM is lined up with the arrow on the instrument. · Press ENTER when the patient is ready. You will now hear the sensor buzz. · The instrument now prompts you to avoid flow in the spiretteTM while it is setting the baseline. It is advisable to block off the spiretteTM at one end to ensure precise setting of the baseline. An audible signal sounds when the baseline is set. · The patient must then insert the spiretteTM into his or her mouth and must fully inhale and exhale for an uninterrupted period of at least 12 seconds. 9.6 OSHA Cotton Dust Protocol (US units only) This is a specialized routine for users who want to ensure that occupational testing and reports meet the requirements of NIOSH/OSHA. The unit will automatically perform as described here, regardless of how the configuration is set. When this protocol is chosen testing and reports are affected as follows: · · · · · ·

Only FVC tests are performed Test quality criteria meets the requirements defined by the Cotton Dust Standard The Knudson 1976 predicted normals are used The best three tests and Volume-Time curves will be saved and printed The curves will be printed in large, validation size There will be no clinical interpretation displayed or printed

9.7 Disability Protocol (US units only) This is a specialized routine for users who want to ensure that testing associated with disability determinations meets the requirements of the Social Security Administration. The unit will automatically perform as described here, regardless of how the configuration is set. When this protocol is chosen testing and reports are affected as follows: · · · · · · · 9.8

A multi-flow calibration is required prior to testing Unit will be accurate to within 1% Only FVC tests are performed The best three tests and Volume-Time curves will be saved and printed The curves will be printed in large, validation size Report will include the calibration results There will be no clinical interpretation displayed or printed Post-Test

The Post-Test is usually performed to determine the response on bronchodilating asthma medication. This is done by treating the patient with a bronchodilator after having performed a FVC or FVL test. Approximately 10 to 20 minutes after the medication (when bronchodilator shows effect) a second FVC or FVL test (“post-Test”) is performed. The results of the pre-test and the post test are then compared on

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the result screen and on the test protocol. Post-Tests can only be added to previous tests on the same day. To add the “Post”-test immediately after the FVC or the FVL test select the field POST on the result screen. When coming from the main menu you can add a post test to a previous test as follows: · · · · · 9.9

Select “Perform Test” in the main menu Choose the field RECALL and press ENTER Scroll through the list of tests until you get to the desired pre-med test and press ENTER Select the field POST Proceed as described in Chapter 9.1 and 9.2 Adding a Trial

If you would like to add trials to a previous test, e.g. if the patient needed a break, please proceed as follows: · · · · ·

Select “Perform Test” in the main menu Choose the field RECALL and press ENTER Scroll through the list of tests until you get to the desired test and press ENTER Select the field ADD Proceed as described in Chapter 9.1 and 9.2

Please mind that it is only possible to add a trial to a previous test that was performed on the same day.

10 Quality Messages and Quality Grades 10.1 Quality Messages The quality messages assist you in conducting the measurement. After each test, they provide information as to whether the test is acceptable or what to do to improve the result. Message

Criterion

Recommended action

Don’t hesitate

Back-extrapolated volume greater than 150 ml or 5% of FVC whichever is greater (for age <= 6: 80ml or 12.5% of FVC whichever is greater)

The patient must exhale all air at once and not exhale in short bursts.

Blast out faster

Time until peak flow greater than 120 ms

The patient must exhale more explosively and as firmly and quickly as possible.

Blow out longer

Expiration time less than 2 seconds or volume during last 0.5 seconds >40 ml when expiration time is <6 seconds

The patient stopped exhaling too early. The patient must exhale still further and force as much air as possible out of his or her lungs.

Good effort, do next

Test meets above criteria

Good test. Only one to two more good tests and the test is complete.

Blast out harder (only in Frontline mode)

Peak flow not reproducible. Difference with respect to best test greater than 1.0 l/s

The test differs greatly from previous best test. The patient can blow even more firmly and achieve a higher peak flow.

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Wait until buzz before blowing out

The time to peak flow (PEFT) is less than 25ms

Instruct the patient to wait until the baseline setting is finished and the device signals that the trial can start

Cough detected. Try again

A cough has been detected

Instruct the patient to avoid coughing during the first second.

Deeper breath

FEV1 or FVC* not reproducible. Difference with respect to best test greater than 150 ml or 100ml if FVC is < 1.0L. (for age <= 6: 100ml or 10% of FEV1 or FVC* whichever is greater)

The test differs greatly from previous tests. The patient can inhale even more deeply and exhale even more air.

Test complete

QC grade A or B reached. After 5 trials loosened to include QC grade C. See QC grade documentation.

The test is complete. An adequate number of good tests is available.

* when using FEV6 instead of FVC, FEV6 is also used for the determination of the quality message

10.2 Quality Grades The quality grades allow you to assess the reliability of the measurement result. Quality grades A to C indicate a reliable result. A quality grade between D and F indicates inadequate test quality. The result must then be interpreted with caution. The quality ratings can be activated or deactivated under “Configuration”. See also Chapter 8. The table below defines the criteria for the classification of quality grades: Rating

Criteria in Diagnostic mode

Criteria in Frontline and NLHEP mode

A

At least 3 acceptable tests (for age < 6: 2 acceptable) AND the difference between the best two FEV1 and FVC values is equal to or less than 100ml (80ml if FVC < 1.0 L; for age < 6: 80ml or 8% of FVC whichever is greater)

At least 2 acceptable tests AND the difference between the two FEV1 and FEV6 values is equal to or less than 100ml

B

At least 3 acceptable tests (for age < 6: 2 acceptable) AND the difference between the best two FEV1 and FVC values is equal to or less than 150ml (100ml if FVC < 1.0 L; for age < 6: 100ml or 10% of FVC whichever is greater)

At least 2 acceptable tests AND the difference between the two FEV1 and FEV6 values is equal to or less than 150 ml

C

At least 2 acceptable tests AND the difference between the best two FEV1 and FVC values is equal to or less than 200ml (150ml if FVC < 1.0 L; for age < 6: 150ml or 15% of FVC whichever is greater)

At least 2 acceptable tests AND the difference between the two FEV1 and FEV6 values is equal to or less than 200 ml

D

At least 2 acceptable trials but the results are not reproducible. Quality message "Result not reproducible" OR only one acceptable trial. Quality message: “Only one acceptable trial”

At least 2 acceptable trials but the results are not reproducible. Quality message "Result not reproducible" OR only one acceptable test. Quality message "Only one acceptable trial”

F

No acceptable test available

No acceptable test available

If the Automated Test QC function is activated the instrument determines automatically which trial is acceptable. For the evaluation of the best trial, the interpretation and the Pre/Post comparison acceptable trials are used first. In the Diagnostic mode the Automated Test QC function can be deactivated (see Chapter 8). In this case each trial can be accepted manually. To do so simply select ACCEPT after the maneuver and the trial will be considered acceptable.