Micro I Diagnostic Spirometer Operating Manual Issue 1.8 Feb 2019

Contents II.

Introduction – USA...50 Package Contents...51 Contraindications, Warnings and Cautions...52 Intended Use...54 Environment...54 Getting Started...54 Configuration...55 Micro I PC Software...56 Operation...61 Main Menu Overview...61 Quick Exam...62 Exam with Predicted Values...64 Post BD Exam...68 NLHEP Mode...68 NLHEP Quality Checks...69 NLHEP QC Grades...70 NLHEP Interpretation...70 Switching Off...71 Maintenance...71 Battery Management...71 Battery Replacement...72 Calibration Check...74 Cleaning Instructions...75 Cleaning the Transducer...76 Servicing...76 Product Lifetime...76 Trouble Shooting Information...77 Safety Designation per IEC 60601-1...78 Electromagnetic Compatibility (EMC) to IEC 60601-1-2...80 Symbols...85 Specifications of the Micro I...87 Consumables and Accessoires...88

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Micro I Diagnostic Spirometer Operating Manual – English

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Introduction

The Micro I is a compact, rechargeable battery operated and fully portable diagnostic spirometer. It is accurate to the requirements of the ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING 2005. Its ergonomic and user-friendly design allows diagnostic spirometry measurements, including predicted values and automatic interpretation, to be made quickly and simply. The Micro I features include: o

Measures FEV1, FVC(FEV6), FEV1/FVC, FEV1/FEV6, PEF, FEF25, FEF75, and FEF 25-75

o

Fully configurable using software supplied

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ECCS, Asian, NHANES III, Kainu (2016) Finnish, Quanjer GLI (2012) or Quanjer GLI (2012) + ECCS predicted values

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Variation from norm as percentage or Z-score

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NLHEP, NICE, or the ATS/ERS interpretation

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Spirometry manoeuvre quality checks

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Post bronchodilator comparison

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NLHEP compliant mode

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Upload of the last patient tested for report generation either to be printed directly or saved as a PDF document and printed or stored in the patient’s electronic medical records.

The spirometer uses the Vyaire 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. Vyaire can supply spirometers to fulfil all your diagnostic and monitoring spirometry needs.

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Package Contents The Micro I is packaged in a convenient carrying case and comes complete with the following items (Fig.1): 1. Micro I spirometer 2. Vyaire Digital Volume Transducer together with disposable cardboard mouthpieces and instruction manual. 3. Universal power supply (36-PSU1017 5VDC 1.2A) 4. Cardboard mouthpiece adapter 5. USB/Charging cable

Fig 1

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Contraindications, Warnings and Cautions Contraindications: It is recommended that patients should not be tested within 1 month of a myocardial infarction. Conditions where suboptimal spirometry are likely: • chest or abdominal pain • oral or facial pain exacerbated by a mouthpiece • stress incontinence • dementia or confusional state Ref: ATS/ERS Task Force: Standardisation of Lung Function Testing. General considerations for lung function testing. M. Miller et al. Eur Resp J 2005:26. 153-161

The following terms are used as follows in this manual Caution: Possibility of injury or serious damage Warning: conditions or practices that could result in personal injury. Please Note: Important information for avoiding damage to the instrument or facilitating operation of the instrument. Note: The device should only be used by trained and qualified personnel.

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CAUTION: Read the manual before use WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases, flammable anaesthetic mixtures or in oxygen rich environments. WARNING: With any other use as described in cleaning instructions, the Volume Transducer, Mouthpiece adaptor and the Paediatric adapter have to be cleaned between patients. WARNING: use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. CAUTION: Mouthpieces are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may degrade materials and lead to an incorrect measurement. CAUTION: Pulmonary filters are single patient use. If used on more than one patient there is a risk of cross-infection. Repeat use may also increase air resistance and lead to an incorrect measurement. CAUTION: Do not allow the patient to handle the spirometer when connected to either the power supply for charging or to a PC when configuring the unit. WARNING: The user must not touch any voltage-carrying parts and the patient at the same time. PLEASE NOTE: The product and the battery you have purchased should not be disposed of as unsorted waste. Please utilise your local WEEE collection facilities for the disposal of this product. PLEASE NOTE: Degree of protection against Ingress of Water is IPX0.

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Intended Use The Micro I Spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient’s lungs. The system is intended for use with Paediatric and adult patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.

Environment Please observe the following precautions: •

Avoid exposing the Micro I to direct sunlight.

•

Avoid operating the spirometer in dusty conditions or near to heating appliances or radiators.

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Do not keep the spirometer in a damp place or expose it to extreme temperatures.

•

Do not direct the transducer holder towards a strong light source whilst operating the spirometer.

Getting Started It is recommended that Micro I spirometer is fully charged before use. The power supply is provided with separate UK, USA and European plugs. Connect the required plug to the power supply and plug in to a mains outlet. Connect the Micro I to the power supply using the USB/charging cable and the charging symbol will appear on the screen. Fully charge for a minimum of 5 hours when used for the first time. Remove the protective film from the display screen before use.

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Configuration When the unit is first turned on it may be configured for your region. This will set the language, height and weight units, date format and predicted values set appropriate for your region. It will also configure the indices to be displayed and whether percentage predicted or Z-score is to be used to show variation from the norm. However all of these settings may be customised using the PC software supplied. Turn the unit on by pressing the on/off button located at the top of the device and the following will be displayed:

Use the up and down arrow keys to highlight the required country and then press ‘Enter’ (↵). This procedure is only required when the unit is first switched on and the selection will be stored for future use. It is recommended that the PC software be used to adjust these settings, if required. Connect Micro I to the PC using the USB cable supplied. Run the software, and turn on the Micro I. The PC software will detect that the Micro I is connected. Follow the onscreen instructions to configure your unit.

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Micro I PC Software This software allows you to customise the settings on your Micro I spirometer, and allows full spiormetry reports containing patient demographics, indices and flow volume and volume time graphs to be generated and saved as a PDF file or printed. Once successfully installed, comprehensive help is available through the Help menu when using the application. System Requirements Micro I PC Software requires certain hardware and software components in order to run properly. PC Requirements An IBM-compatible PC is required, with hardware that meets or exceeds the following minimum requirements. Processor: 800 MHz or above RAM: 256 MB Free Disk Space: 50 MB Video: 800x600, 256 colours. It is recommended that a resolution of at least 1280x1024 be used to enable the full benefits of the multi-window interface. At least one free USB port. (An additional USB port will be required for USB enabled spirometers) Operating System Requirements Micro I PC Software will run on the following operating systems: Windows 7 32 bit Windows 7 64 bit Windows 8.1 64 bit Windows 10 64 bit

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Installing Micro I PC Software Before you begin, please ensure your computer meets the minimum system requirements and the user installing the software has administrative user rights. Close any other applications that are running. Insert the installation CD into your CD-Rom drive. The setup program should launch automatically, displaying the welcome dialog box, click ‘Next’ to continue. If the setup program does not launch automatically use Windows Explorer to manually select the CD drive then open the file named Micro I PC Software.exe. The license agreement will be displayed. Please read the complete document and ensure you understand fully before accepting the terms of the license. Click ‘Next’ to continue. The select destination location dialog will be displayed showing the directory where the Micro I PC Software will be installed. The default location is: C:Program FilesVyaireMicro I PC Software To change this location select ‘Browse’. Click ‘Next’ to display the Select program manager group dialog. This will be the location where the Micro I PC Software launch icon will be placed under the Start Menu. Either a new location can be entered or an existing location used. Click ‘Next’ to display the installation options dialog containing the following option: Add Micro I PC Software icon to the desktop. Click ‘Next’ to start copying the files to your system. Once the files have finished copying to your system you will be advised that the Micro I PC Software has been successfully installed

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and that it would be advisable to restart your PC before using the application. Click ‘Finish’ to complete the installation process. Running Micro I PC software Connect your Micro I to a USB port on the PC using the cable provided. The Micro I will take power from the USB port on the PC. Please be advised that the Micro I requires a High Current USB port, and if connected to a Low Power USB port the device will turn itself off and fail to respond to any key presses until disconnected. Low Power USB ports are commonly found on keyboards and unpowered USB hubs and should not be used. Whilst connected to the PC the Micro I will display:

Do not allow the patient to handle the spirometer during this procedure.

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The Micro I PC software will automatically be launched when a Micro I unit is connected to the PC, the first screen will show:

From this screen you can enter an ID and the patient’s names to generate a report. The Patient options allows the last results to be uploaded from the Micro I and print preview of the report can be viewed in preparation for printing or alternatively a PDF of the report can be generated for saving to a specified location. Please note: The patient ID can contain a maximum of 20 characters. Please note: IF Quanjer-GLI (2012) predicted values are selected, the number of indices will be limited to those of the published set, it is also not possible on the printed report to have a predicted area on the flow volume or volume time graphs if the GLI-2012 predicted values have been chosen. In the Actions section the user has the choice of two Options either change the device settings or adjust the Micro I internal clock.

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When the change settings option is used the display will change to:

By selecting the ‘Custom’ option at the top of the screen all of the Micro I features may be tailored to you specific requirements.

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Operation The Micro I is designed to suit a range of applications from the very simplest spirometry test where only a few indices are required to be displayed to more complex operation where deviation from the norm, bronchodilator response, and interpretation of results are required. The main menu is displayed after the initial configuration and subsequently when the unit is turned on:

Main Menu Overview Quick Exam Use this function to take an immediate spirometry measurement with no predicted values or interpretation. Exam with Predicted This function requires the entry of the patient’s demographics so that predicted values and interpretation may be calculated and displayed. Post BD Exam This function allows the post bronchodilator response to be measured. The response is measured with respect to the previously measured baseline obtained using either the Quick Exam or the Exam with Predicted options.

The last recorded baseline examination is

automatically stored when the unit is turned off and will be available for a post bronchodilator comparison when the unit is turned on.

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Last Results This option is used to view the results of the last stored examination. Settings This option allows the user to adjust various settings including date, time and language and to perform a calibration check.

Quick Exam After selecting this option the display will change to:

The Micro I may be used directly with a MicroGard filter or with a disposable cardboard mouthpiece with the adapter supplied. Insert mouthpiece or MicroGard filter into the mouthpiece holder of the spirometer. Instruct the patient to inhale as deeply as possible, seal their lips around the mouthpiece and exhale as hard and as fast as possible until no more air can be exhaled.

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The spirometry results for that blow are then displayed together with the manoeuvre quality check based upon ATS/ERS guidelines:

Further indices, if configured, and the best results from a sequence of blows may be displayed by pressing the down key. Each manoeuvre is quality checked for a slow start, abrupt end, short blow, poor effort or cough according to ATS/ERS 2005 guidelines. Please note that the percentage of predicted value and the interpretation are not available for the Quick Exam option. Press Enter to display:

To repeat the test select Blow Again and press Enter.

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Exam with Predicted Values When this option is selected the following is displayed:

The date of the birth displayed will be the last patient tested, select ‘Yes’ to confirm the date of birth is correct or ‘No’ to enter the date of birth of the patient to be tested. If ‘No’ is selected then the screen will change to allow the correct date of birth to be entered. Use the up and down keys to enter the date of birth and press the enter key after each correct entry has been made.

If ‘Yes’ is selected and the date of birth is correct then the patient details screen will be displayed.

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The up and down keys should also be used to adjust the patient’s age and then press enter. Repeat for gender, height and racial origin. If a mistake is made then simply touch the back key to go back to the previous entry. The racial origin selected applies a percentage drop to the volumetric predicted values to be applied for the patient. These ethnic corrections for ECCS are as follows: Population

Percentage drop

Caucasian

0

Non-Specified

0

Polynesian

10

Asian

10

Afro Caribbean

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Press Enter when the required correction has been selected. If NHANES III predicted values are used then the ethnic origin will be used according to the NHANES III equations. If Quanjer-GLI (2012) predicted values are used then the ethnic origin will be used according to Quanjer-GLI (2012) equations. Please note that the Micro I may be configured to accept height in inches.

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If a mistake is made then simply touch the back key to go back to the previous entry. When all the patient data has been entered the following screen will be displayed and a spirometry test may be performed:

After performing a test the results are displayed:

Each manoeuvre is quality checked for a slow start, abrupt end, short blow, poor effort or cough according to ATS/ERS 2005 guidelines. An asterix ( * ) at the end of the line denotes a result below the lower limit of normality. If additional indices were chosen during configuration, press the down arrow key to view these. When a sequence of blows is recorded, the results and the quality check refer to the current blow but the interpretation is based upon the best result of the sequence.

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