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Summary of Contents for Micro Direct Micro I
- Page 1 Micro I Diagnostic Spirometer Operating Manual Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-800-588-3381 www.mdspiro.com 122-14 Issue 1.8 MD...
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Page 2: Table Of Contents
Product Lifetime ............... 25 Troubleshooting Information ............. 25 Safety Designation per IEC 60601-1 ........26 Electromagnetic Compatibility (EMC) to IEC 60601-1-2 ... 27 Symbols ................... 31 Specifications of the Micro I ............. 33 Accessories................34 Customer Contact Information ..........34... -
Page 3: Introduction
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: STANDARDIZATION 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. -
Page 4: Package Contents
Micro Direct can supply spirometers to fulfil all your diagnostic and monitoring spirometry needs. Package Contents The Micro I is packaged in a convenient carrying case and comes complete with the following items: Micro I Spirometer Digital Volume Transducer with disposable cardboard mouthpieces and instruction manual. -
Page 5: Contraindications, Warnings And Cautions
Contraindications, Warnings and Cautions Contraindications: It is recommended that patients should not be tested within one month of a myocardial infarction. Conditions where suboptimal spirometry are likely: • chest or abdominal pain • oral or facial pain exacerbated by a mouthpiece •... - Page 6 CAUTION: Read the manual before use WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases, flammable anesthetic mixtures or in oxygen rich environments. WARNING: With any other use as described in cleaning instructions, the volume transducer, mouthpiece adapter and the pediatric adapter must be cleaned between patients.
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Page 7: Intended Use
The power supply is provided with separate UK, USA and European plugs. Connect the required plug to the power supply and plug into an electrical outlet. Connect the Micro I to the power supply using the USB/charging cable and the charging symbol will appear on the screen. -
Page 8: Configuration
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 when the Micro I is connected. Follow the onscreen instructions to configure your unit. - Page 9 1280x1024 be used to enable the full benefits of the multi-window interface. At least one free USB port. Operating System Requirements Micro I PC Software will run on the following operating systems: Windows 7 32/64 bit Windows 8.1 64 bit Windows 10 64 bit...
- Page 10 ‘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.
- Page 11 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...
- Page 12 From this screen you can enter an ID and the patient’s name to generate a report. The patient options allow the last results to be uploaded from the Micro I and print preview of the report can be view in preparation of printing or alternatively a PDF of the report can be generated for saving to a specified location.
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Page 13: Operation
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... -
Page 14: Quick Exam
Quick Exam After selecting this option, the display will change to: The Micro I may be used with a SpiroSafe filter or a MicroCheck disposable cardboard mouthpiece with the adapter supplied. Insert mouthpiece or SpiroSafe filter into the mouthpiece holder of the spirometer. -
Page 15: Exam With Predicted Values
Further indices, if configured and the best results from a sequence of blows may be displayed by pressing the down key. Each maneuver is quality checked for a slow start, abrupt end, short blow, poor effort or cough according to ATS/ERS 2005 guidelines. - Page 16 of birth and press ‘Enter’ ( ) key after each correct entry has been made. If ‘Yes’ is selected and the date of birth is correct, the patient details screen will be displayed. The up and down keys should also be used to adjust the patient’s age and then press ‘Enter’...
- Page 17 If NHANES III or Quanjer-GLI (2012) predicted values are used, the ethnic origin will be used according to the author’s equations. Please note the Micro I may be configured to accept height in centimeters. If a mistake is made, simply touch the back key to go back to the previous entry.
- Page 18 () key to return to the results screen. The Micro I may be configured to display the Z score instead of the percentage of predicted values where data from the predicted value sets are available:...
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Page 19: Post Bd Exam
In this mode the functionality of the Micro I becomes fully compliant with the National Lung Health Education Program requirements. -
Page 20: Nlhep Quality Checks
NLHEP Quality Checks For the interpretation to be displayed, a maneuver must pass a set of enhanced quality checks. After the patient has performed a poor-quality maneuver, one of the three following messages will appear: Message Criteria Recommended action Don’t Back-extrapolated The patient should blast out hesitate... -
Page 21: Nlhep Qc Grades
When two maneuvers fail either of the consistency checks, the best individual results of the two are saved (FEV1, FEV6 and PEF individually). When any of the above messages appear, instruct the patient on how to improve their maneuver and demonstrate the correct maneuver yourself. -
Page 22: Maintenance
The Micro I’s internal batteries should be fully charged on first use. A fully charged device will hold a charge for a few months. If the Micro I is not used for longer then this, it must be recharged every few months to keep the battery alive. -
Page 23: Battery Replacement
Micro I is now ready for portable use. Note: Micro I may also be charged from a PC or laptop using the USB cable provided. NOTE: When disconnecting the USB cable from the Micro I, make sure to squeeze both sides of the jack to unlock the cable from the unit. - Page 24 To aid this process, clip 1 has a recess molded into the device body to allow a small flat bladed screwdriver to be carefully slid under the clip to release it. Once released, work the screwdriver around to clips 2, 3 and 4. Finally slide the cover off the bottom of the unit which in turn releases clips 5 and 6.
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Page 25: Calibration Check
If this happens, check the syringe and the connections for leaks and repeat the check. If the Micro I is repeatedly outside the calibration range, the unit will have to be returned to Micro... -
Page 26: Cleaning Instructions
When using a pediatric/adult disposable mouthpiece without a filter under the prerequisite that the patient was instructed only to exhale into the Micro I device, the following parts must be cleaned once a day: volume transducer, mouthpiece adapter and pediatric adapter. -
Page 27: Servicing
There are no user serviceable parts in the Micro I. Product Lifetime The Micro I meter is designed for a product lifetime of 5 years. Troubleshooting Information Should you encounter problems operating your Micro I spirometer, please consult the table below:... -
Page 28: Safety Designation Per Iec 60601-1
• The adapter transforms the mains voltage (100-240 Volts) to a safe voltage (5V DC) • Make sure the adapter does not get wet • Do not use a damaged adapter • Always unplug your Micro I before cleaning... -
Page 29: Electromagnetic Compatibility (Emc) To Iec 60601-1-2
(including other medical devices). The purposes of this testing is to ensure the Micro I is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the Micro I. - Page 30 CAB1098 USB Cable (Micro 1 to PC or to PSU) The Micro I has an essential performance – when verified with a 3 liter syringe the readings remain within a tolerance of +/- 3.5% and unit firmware must not cease operating. In the unlikely event of a Fast Transient / ESD event occurring, the device should be reset and located away from the source of interference.
- Page 31 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Micro I is intended for use in the electromagnetic environment specified below. The customer or the user of the Micro I should assure that it is used in such an environment Emission Test...
- Page 32 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Micro I is intended for use in the electromagnetic environment specified below. The customer or the user of the Micro I should assure that it is used in such an environment. Immunity...
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Page 33: Symbols
Symbols Type B device In accordance with Directive 93/42/EEC Disposal in compliance with your local waste management facility Consult the instructions for use Manufacturer Date of Manufacture Serial Number Federal U.S. law restricts this device to sale by or Rx only on the order of a physician. - Page 34 Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of the manufacture. The software may be used or copied only in accordance with the terms of that agreement. No part of the manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording for any purpose without the written permission of the...
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Page 35: Specifications Of The Micro I
Specifications of the Micro I Measurements: Forced Expiratory Volume in 1 second (FEV Forced Expiratory Volume in 6 seconds (FEV Forced Vital Capacity (FVC) Forced Expiratory Ratio (FEV /FEV Forced Expiratory Ratio (FEV /FVC) Peak Expiratory Flow Rate (PEF) Mid Expiratory Flow (FEF... -
Page 36: Accessories
48-70 Protex Disinfectant Wipe Customer Contact Information For all sales order processing for products, training and spare parts, service and technical support inquiries, please contact the following: Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 Telephone: 207-786-7808 Toll Free:...
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