Micro Direct Micro I User manual

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
February 2019

CONTENTS
Introduction................................................................................1
Package Contents......................................................................2
Contraindications, Warnings and Cautions.................................3
Intended Use..............................................................................5
Environment...............................................................................5
Getting Started...........................................................................5
Configuration..............................................................................6
Micro I PC Software...................................................................6
Operation.................................................................................11
Main Menu Overview ...............................................................11
Quick Exam..............................................................................12
Exam with Predicted Values..................................................... 13
Post BD Exam..........................................................................17
NLHEP Mode...........................................................................17
NLHEP Quality Checks............................................................18
NLHEP QC Grades..................................................................19
NLHEP Interpretation...............................................................19
Switching Off............................................................................19
Maintenance ............................................................................20
Battery Management................................................................20
Battery Replacement................................................................ 21
Calibration Check.....................................................................23
Cleaning Instructions................................................................ 24
Cleaning the Transducer..........................................................24
Servicing..................................................................................25
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

1
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.
The Micro I features include:
✓Measures FEV1, FVC(FEV6), FEV1/FVC, FEV1/FEV6,
PEF, FEF25, FEF75 and FEF25-75
✓Fully configurable using software supplied
✓ECCS, Asian, NHANES III Kainu (2016) Finnish, Quanjer
GLI (2012) or Quanjer GLI (2012) + ECCS predicted
values
✓Variation from norm as a percentage or Z-score
✓NLHEP, NICE or the ATS/ERS interpretation
✓Spirometry maneuver quality checks
✓Post bronchodilator comparison
✓NLHEP compliant mode
✓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 a 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 vapor) 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.

2
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:
1Micro I Spirometer
2 Digital Volume Transducer with disposable cardboard
mouthpieces and instruction manual.
3Universal power supply (PSU1017 5VDC 1.2A)
4 Cardboard mouthpiece adapter
5 USB/charging cable

3
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
•stress incontinence
•dementia or confused state
Ref: ATS/ERS Task Force: Standardization 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.