Micro Direct MD SPIRO Micro MD6300 Instructions For Use Manual Download Page 1 | Manualshive

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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: [email protected]

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Summary of Contents for 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: ...y disease Frequent colds Assessment of congestive heart failure CPT Codes for Spirometry 94010 Spirometry Complete Includes graphic record total and timed vital capacity expiratory flow rate measureme...

Page 3: ...5 3 Reporting 12 5 4 Calibration Verification 13 5 5 Configuration Options 15 6 Power Management 17 6 1 Batteries 17 6 2 Power Save Mode 18 7 Cleaning Hygiene 18 7 1 Preventing Cross Contamination of...

Page 4: ...SpiroSafe filter provides a significant level of protection of the subject the device and the user against cross contamination during spirometry maneuvers A SpiroSafe filter is for single use only 4...

Page 5: ...e instrument is measuring accurately The Micro Spirometer should never be outside accuracy limits A calibration verification should be completed after cleaning or disassembling the spirometer after ad...

Page 6: ...quipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed...

Page 7: ...Computer Shown for illustration purposes only and not supplied 1 USB Flash Drive containing Device Studio Software 2 Power On Off Button 3 Micro USB Port 4 Plinth 5 Flowhead 6 Flowhead Cone 7 LCD Touc...

Page 8: ...ice Studio the Micro Spirometer must be connected to the computer using the USB cable via ports marked with the symbol If the device has just been unpacked or transported ensure it is left sitting ful...

Page 9: ...whead 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 Continue to the temperature e...

Page 10: ...oup are on the second screen and may be enabled in the Configuration Menu Subject Options 3 To enter the information for Date of Birth Height and Weight touch the blank field on the screen to open the...

Page 11: ...ubject should Sit upright and maintain this posture throughout the test Fit the noseclip and relax Place SpiroSafe Filter in mouth and close lips around the mouthpiece Seal lips around the mouthpiece...

Page 12: ...eft right arrows to select which test results to view The tests are shown in order of rank best is ranked number 1 then 2 3 etc 9 To delete the current blow Select the Delete option from the side menu...

Page 13: ...to return to normal mode These are not enabled during test 10 The results summary at the top of the screen shows the FVC and FEV1 of the last blow 11 The number of tests for VC or the number of usabl...

Page 14: ...Note A session ends and is saved when one of the following occur the device is turned off a new subject is created or the device is connected to Device Studio 5 2 3 Post Bronchodilator Post Test A Po...

Page 15: ...and in the Main Menu 3 When connected the remote mode icon will display on the Micro Spirometer 4 Device Studio will search for assessments on the device The user will be presented with the download...

Page 16: ...e a calibration verification 1 Select the Configuration icon on the Main Menu screen 2 Select the calibration verification icon 3 Enter the syringe volume serial number and ambient temperature using t...

Page 17: ...or an issue with the flowhead device contact technical support Outside 3 6 purple syringe and shows 3 6 on the top of the screen The higher the the more severe the issue Over 3 repeat calibration ver...

Page 18: ...if the flowhead is dropped or replaced and if EMI Electromagnetic Interference is suspected or possible 5 5 Configuration Options To access the Configuration menu press the icon on the Main Menu scre...

Page 19: ...VC of FVC FEV 5 Forced Expiratory Volume after 0 5 seconds L PIF L s Peak Inspiratory Flow L sec FMFT Forced Mid Expiratory Flow Time sec FET Forced Expiratory Time sec FEV 5 FVC Ratio FEV 0 5 of FVC...

Page 20: ...etails on performing a Calibration Verification 4 About Contains information about the software which should be used if making inquiries to the manufacturer or a service agent This information include...

Page 21: ...he device out of 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 SpiroSaf...

Page 22: ...utine basis Examine cone and flow conditioning mesh filter for damage or contamination If damaged or blocked it should be replaced with a new part Examine the Fleisch element and replace if damaged If...

Page 23: ...accuracy 9 Fault Finding Guide Problem Fault Symptoms Calibration verification variations 3 False readings suspected Possible Solutions In probable order The error indicates the severity of the issue...

Page 24: ...g is connected correctly Electronics failure Contact support 9 1 Software Check Information about the device may be obtained from the About option in the Configuration Menu This information may be use...

Page 25: ...ro com support mdspiro com Website www mdspiro com 9 Consumables and Accessories Cat No Description 3385 SpiroSafe Viral Bacterial Filters 100 3304 Nose Clips 20 3325 3 Liter Calibration Syringe 69131...

Page 26: ...rating 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 Do not dispose of these prod...

Page 27: ...reports The Fleisch flowhead is used for testing and is integral to the device 13 Technical Specifications Product Micro Spirometer Model MD6300 Flow Detection Principal Fleisch Type Pneumotachograph...

Page 28: ...ance Flow measurement output Essential Performance Test Limits Flow accuracy 10 or 10 L min with 3 or 3 L min allowed for test apparatus ISO 23747 Service Life The recommended service life of the devi...

Page 29: ...Model MD6300 Micro Spirometer to the Medical Devices Directive of the European Community The Model MD6300 Micro Spirometer is intended for use in a variety of healthcare environments e g primary care...

Page 30: ...ly for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Model MD6300 micro is...

Page 31: ...terference is evident or possible Loss or degraded performance due to EMI that exceeds the test levels in immunity test tables above will result in a failed calibration verification on the Micro Spiro...

Page 32: ...s IIa per Annex IX of the MDD also meets the provision of the Essential Requirements Annex I via compliance with Annex II of the Medical Devices Directive as per Article 11 section 3a excluding point...

Page 33: ...ny s literature and user manuals The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above provided the failure can be recreated and...

Page 34: ...0 J30 5 Asthma Mild Intermittent J45 20 J45 22 Asthma Mild Persistent J45 30 J45 32 Asthma Moderate Persistent J45 40 J45 42 Asthma Severe Persistent J45 50 J45 52 Asthma Unspecified J45 901 J45 909 C...

Page 35: ...espiratory conditions due to unspecified external agent J70 9 Sarcoidosis of the Lung D86 0 Sarcoidosis of the Lung with sarcoidosis of the lymph nodes D86 2 Bronchiolitis Acute J21 0 J21 9 Bronchitis...

Page 36: ...rperium O99 330 O99 335 Wheezing R06 2 Use additional code after the primary diagnosis to identify any tobacco use dependence or exposure to tobacco smoke Please Note Information in this manual is sub...

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