Related Manuals for Micro Direct MD SPIRO Micro MD6300
Summary of Contents for Micro Direct MD SPIRO Micro MD6300
- Page 1 Micro Model MD6300 Instruction for Use Current Edition (Issue 2, 29-Jun-2022) Cat. No. 09360 Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 Toll Free: 800-588-3381 Email: support@mdspiro.com...
- Page 2 Indications for Spirometry Spirometry has been used extensively to measure lung function capability and to recognize and treat many diseases associated with the impairment of healthy lung functions. Spirometry today provides great insight into the status of any person’s health. Spirometry is a simple diagnostic tool used to define a subject’s lung condition.
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Page 3: Table Of Contents
Table of Contents 1. Indications for Use ................1 2. Contraindications, Warnings, Precautions and Adverse Reactions ..1 3. Main Components of the Micro Spirometer ......... 3 3.1 Features of the Micro Spirometer ..........5 4. Setting Up the Micro Spirometer ............5 3. -
Page 4: Indications For Use
Micro Direct intends a new SpiroSafe Filter be used for every subject to prevent cross contamination. Using a new SpiroSafe filter provides a significant level of protection of the subject, the device and the user against cross contamination during spirometry maneuvers. - Page 5 Take care not to block the flowhead cone with tongue or teeth during testing. A ‘spitting’ action or cough will give a false reading. 10. Subject fatigue may occur during spirometry testing depending on the subject’s characteristics e. g., age, health status. For safety reasons, testing should be preferably done in the sitting position, using a chair with arms and without wheels.
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Page 6: Main Components Of The Micro Spirometer
22. If the flowhead is removed from the Micro Spirometer (when disassembling for cleaning and/or to attach the remote flowhead adapter), care should be taken with the exposed edges. During normal use, these edges are covered, are not accessible by the user or subject. - Page 7 Figure 1 The main components of the Micro Spirometer USB Flash Drive containing Device Studio Software Power (On/Off) Button Micro USB Port Plinth Flowhead Flowhead Cone LCD/Touch Panel Display Battery Compartment (4 x 1.5V AAA Batteries) Note: Computer Shown for illustration purposes only and not supplied.
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Page 8: Features Of The Micro Spirometer
3.1 Features of the Micro Spirometer The features include: • Fleisch pneumotachograph • Removable flowhead • Touch screen color display • Choice of predicted values • Report generation through Device Studio software • Storage of test and demographic information 4. Setting Up the Micro Spirometer Insert 4 x 1.5V AAA batteries into the battery compartment. -
Page 9: Operating Instructions
Figure 2 Micro with remote flowhead Micro Device Device Cap Flowhead Connection Tubing Remote Flowhead Adaptor Flowhead Flowhead Cone 3. Operating Instructions On first time use, the Micro opens on the Setup screen for Date and Time . Enter the current date and time. Press the forward icon to save. -
Page 10: Entering Subject Data
New Subject VC Test FVC Test Post Test The test icons will appear greyed out and can’t be selected until a subject is created. The Post Test icon becomes active when an FVC pre-test is performed. The status bar at the top on the screen shows the following after tests have been completed: 1. -
Page 11: Conducting A Test
To exit the new subject screen, press the forward button. 5.2 Conducting a Test To prepare for a test session: Ensure the accuracy of the device has been checked. (Refer to the section 5.4 on Calibration Verification). Ensure the subject’s details have been entered on the Micro Spirometer. -
Page 12: Fvc Test
Results may be viewed as either: Volume/time (V/t) Volume Bar graph by pressing the icon on the side menu. These are not enabled during test. View a full screen graph by using the zoom button at the side of the test screen. Zoom in to return to normal mode. - Page 13 Then exhale with maximal effort until no more air can be expelled (when a plateau has been reached or forced expiratory time (FET) reaches 15 seconds). It is vital the operator encourages the subject to keep exhaling to ensure all air is expelled. The operator should repeat instructions as necessary, with enthusiasm.
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Page 14: Post Bronchodilator (Post) Test
14. To delete the current blow: • Select the Delete option from the side menu. Two delete icons will appear: Delete (green) Press to confirm the deletion. Delete (red) : Press to cancel the deletion. To clear/delete all the sessions on the device, connect to Device Studio as outlined in section 5.3 and move all the data to Device Studio to clear if from the device. -
Page 15: Reporting
each session. The session information will also include the subject details entered and the best pre-test if there is a Post-test session. The Micro Spirometer is intended to be used as a temporary storage device. It may be connected to Device Studio to produce pdf reports of the session data, this will move all subject/sessions to the Device Studio application and flag them as deleted on the device except for the last FVC Pre-test. -
Page 16: Calibration Verification
If more than one test is required for the same subject, the Micro Spirometer should be switched off and on again between tests so they are registered as separate sessions and separate reports can be generated. 5.4 Calibration Verification The Micro Spirometer should never be outside accuracy limits unless damaged or in a fault condition. - Page 17 will be displayed on the top of the screen and a syringe with a green tick pass will display. Pressing the forward key will return to the Main Configuration menu and the calibration verification is recorded. In the unlikely event the result is outside 3% or nonreproducible, an error icon will display.
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Page 18: Configuration Options
A calibration verification report may be printed or saved if required, see section 5.3 Reporting If the procedure was followed correctly and the error icon is showing, the calibration verification should be repeated. If the error continues to show, contact the manufacturer using the contact information in this document. Note: To exit the Calibration Verification screen without performing a check, press the forward key to return to the Configuration Menu... - Page 19 • Temperature: enter the temperature, up to 2 decimal places. The default setting is 23°C. Parameters: Choose to select which parameters to display on the results screen, use the left/right arrows to navigate between screens. A maximum of 8 parameters can be selected. The following are all available parameters: Parameter Definition...
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Page 20: Power Management
FIF50 Forced Inspiratory Flow at 50% of the FIVC (L/sec) FIF75 Forced Inspiratory Flow at 75% of the FIVC (L/sec) FIF50/FEF50 Ratio FIF 50% of FEF 50% FEF50/FIF50 Ratio FEF 50% of FIF 50% Maximum Voluntary Ventilation indirectly calculated MVVind from the FEV1 (L/min) Rind Airways Resistance indirect measurement... -
Page 21: Power Save Mode
7. Cleaning & Hygiene 7.1 Preventing Cross-Contamination of Subjects A spirometer is not designed or supplied as a ‘sterile’ device. Micro Direct intends that a new SpiroSafe filter be used for every subject to prevent cross contamination. Using a new SpiroSafe provides a significant level of protection for the subject, the device and the user against cross contamination during spirometry maneuvers. -
Page 22: Inspection Of The Micro Spirometer
If it is suspected that the flowhead has become contaminated or where user risk assessment identifies a need for higher level of decontamination, then it should be cleaned as per the instructions in ‘Cleaning and Hygiene’ on the Micro Direct website. -
Page 23: Remote Flowhead
8. Remote Flowhead The Micro flowhead can be set up to work remotely from the device. This may be useful if the display needs to be monitored while the subject uses the device. 1. Slide the flowhead away from the device from left to right. You may need to push firmly to get it to move. -
Page 24: Software Check
Micro Direct or a service agent. 9.2 Product Useful Life Checks To ascertain whether the device has exceeded its useful life, Micro Direct recommends checking the flowhead and the real time clock. The flowhead may be checked with the daily calibration verification, to be completed by the clinician/healthcare professional and during the periodic inspection of the device. -
Page 25: Customer Service
Any serious incident that has occurred in relation to the device should be reported to Micro Direct and the Regulatory Authorities of the country. Refer to the contact information listed below. Toll Free:... -
Page 26: Explanation Of Symbols
11. Explanation of Symbols Type BF equipment Class II Power Rating Voltage DC Batt V for battery DC for power supply Instructions for Use; operating instructions Manufacturer Date of Manufacture (Date format yyyy-mm-dd) USB connector On/Off The device must be taken to separate collection at the product end-of-life. -
Page 27: Description Of The Micro Spirometer
Recycle Keep Dry QR Code – matrix bar code Restricted to sale by or on the order of a physician. MR Unsafe – Do not use this device in an MRI environment. 12. Description of the Micro Spirometer The Micro Spirometer is a handheld spirometer which measures subject respiratory parameters. - Page 28 Design Limits: 50 – 104° F Operating Humidity Range 30% - 75% 850hPa – 1060hPa Ambient Pressure Range Performance Standards the Micro ATS/ERS 2019, ISO 23747:2015 & Spirometer meets or exceeds ISO 26782:20009 Electrical Safety Standards EN 60601-1:2006 + A1:2013 EMC Standards EN 60601-1-2:2015 + A1:2021 Home Use Standard...
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Page 29: Ce Notice
Other: • .Net Framework 4.6.1 • USB Port • Bluetooth Support • PDF Viewer Notes: • All values displayed are expressed as BTPS values. • Take care not to block the mouthpiece with tongue or teeth. A ‘spitting’ action or coughing will give false readings. •... - Page 30 EN60601-1-11:2015 – Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – collateral standard: Requirement for medical electrical equipment and medical electrical systems used in the home healthcare environment. Coexistence: ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence EN 60601-1-2:2015 + A1:2021 - Emissions tests During the immunity testing below the device continued to operate within...
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Page 31: Fda Notice
Magnetic Field Immunity EN61000-4-8 8A/m 30kHz 8A/m 30kHz Power Magnetic 65A/m 134.2 k Hz Field Immunity (2.1 kHz PM) 65A/m 134.2 k Hz (2.1 kHz PM) EN61000-4-8 7.5A/m 13.56 M Hz 7.5A/m 13.56 M Hz (50 kHz PM) (50 kHz PM) Medical Devices may be affected by mobile RF communications equipment including cellular telephones and other personal or household devices not intended for medical facilities. -
Page 32: Eu Declaration Of Conformity
16. EU Declaration of Conformity Product: MD6300 Micro Spirometer The manufacturer hereby ensures and declares the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards. • European Medical Devices Directive {MDD} 93/42/EEC, as amended. -
Page 33: Guarantee
17. Guarantee Subject to the conditions listed below, the manufacturer and its associated companies (hereinafter called the Company) guarantee to repair or at its option replace any component thereof, which in the opinion of the Company is faulty or below standards as result of inferior workmanship or materials. - Page 34 This Guarantee is offered as an additional benefit to the Consumer's statutory rights and does not affect these rights in any way. CD-10 Codes for Spirometry Diagnosis Code Acute Bronchitis J20.0-J20.9 Allergic Rhinitis, Other J30.81-J30.89 Allergic Rhinitis, Unspecified J30.9 Vasomotor and Allergic Rhinitis J30.0-J30.5 Asthma, Mild, Intermittent J45.20-J45.22...
- Page 35 Pulmonary Disease Interstitial Pulmonary Diseases, J84.9 Unspecified Pneumoconiosis Due to Asbestos and Other Mineral Fibers Pneumonitis J67.0-J67.9 Pulmonary, Fibrosis J84.10 Respiratory conditions due to inhalation of chemicals, gases, J68.0-J68.9 fumes and vapors Respiratory conditions due to J70.9 unspecified external agent Sarcoidosis of the Lung D86.0 Sarcoidosis of the Lung with...
- Page 36 Shortness of Breath R06.02 Systemic Sclerosis with lung M34.81 involvement Contact with and (suspected) exposure to environmental Z77.22 tobacco smoke (acute) (chronic)** Nicotine Dependence** F17.200-F17.299 Tobacco Use (NOS)** Z72.0 Occupational exposure to Z57.31 environmental tobacco smoke** Personal history of Z87.891 nicotine dependence** Smoking (tobacco) complicating pregnancy,...
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