Micro

Direct

MicroLab Operating Manual

Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner.

MAN1300

085-73

Issue 1.6

February 2019

Micro Direct, Inc.

803 Webster Street

Lewiston, ME 04240

1-800-588-3381

www.mdspiro.com

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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.

Generally speaking, spirometry is a simple diagnostic tool used to define a subject's lung condition. The major indications for spirometry are:

✓ Dyspnea (shortness of breath)

✓ Exercise induced coughing

✓ Chest tightness

✓ Smokers over 45 years of age (NLHEP recommendations)

✓ Obesity

✓ Pre-operative testing

✓ Occupational exposure to dust and/or chemicals

✓ Ongoing assessment of patients receiving bronchodilator treatments

✓ Determination and/or documentation of pulmonary disability

✓ Asthma diagnosis

✓ Pre-existing pulmonary 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 measurement (s) with or without maximal voluntary ventilation

94060 - Bronchodilation Responsiveness

Spirometry as in 94010, pre-and post-bronchodilator or exercise

94070 - Bronchospasm Provocation Evaluation

Multiple spirometric determinations after bronchodilator with spirometry as in 94010

94150 - Vital Capacity

Total (separate procedure)

94200 - Maximal Voluntary Ventilation

Maximum breath capacity

94375 - Flow Volume Loop

Respiratory Flow Volume Loop

95070 - Inhalation Bronchial Challenge Testing

(Not including necessary pulmonary function tests), with histamine, methacholine or similar compounds.

94464 - Bronchodilator Administration

Demonstration and/or evaluation of patient utilization of an aerosol generator, nebulizer and meter dose inhaler or IPPB device

Contents

Introduction.....1
Contraindications.....1
Warning and Cautions.....2
Indication for Use.....2
Overview.....4
Getting Started.....5
Calibration Check (Verification).....14
Customization.....17
Administration Mode.....18
Paper Loading.....19
Switching Off.....20
Charging Procedure.....20
PC connection using SPCS.....20
Looking after your Spirometer.....21
Product Lifetime.....21
Cleaning Instructions.....21
External Surfaces of the Spirometer.....21
Cleaning the Accessories.....22
Cleaning the Transducer.....22
Servicing.....23
Troubleshooting Information.....24
Safety Designation per IEC 60601-1.....26
Electromagnetic Compatibility (EMC) to IEC 60601-1-2.....27
Symbols.....31
Specifications.....32
Spirometry Measurements.....32
Consumables / Supporting Products.....34
ICD-10 Codes for Spirometry.....35

Introduction

The MicroLab is a mains/battery operated portable spirometer with the unique combination of ease of use and sophistication. Ease of use is assured using context sensitive help screens, accessed at a touch of a button, that explain every MicroLab feature.

The MicroLab 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. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.

Test results may be uploaded to a PC using the optional Spirometry PC Software and patient details may be downloaded to the MicroLab.

Stored data may be printed to the integral thermal or uploaded to a PC using the optional Spirometry PC Software (SPCS).

Contraindications

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

Warning and Cautions

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

Note: Important information for avoiding damage to the instrument or facilitating operation of the instrument.

Note: Patients below the age of four (4) may struggle to perform spirometry correctly and reproducibly.

Note: The device should be used by trained and qualified personnel.

Indication for Use

The MicroLab spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs.

The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.

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