Micro Direct MD SPIRO Micro MD6300 Manuale utente

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]

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. 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

✓To support or exclude an 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

Diagnosis and ICD-10-CM Codes on back cover

 
 
Table of Contents 
Indications for Use...............................................................................1 
Contraindications, Warnings, Precautions and Adverse Reactions..... 1 
Main Components of the Micro Spirometer.........................................3 
1 Features of the Micro Spirometer................................................5 
Setting Up the Micro Spirometer .........................................................5 
Operating Instructions .........................................................................6 
1 Entering Subject Data .................................................................7 
2 Conducting a Test2......................................................................8 
2.1 VC Testing ............................................................................... 8 
2.2. FVC Test................................................................................9 
2.3 Post Bronchodilator (Post) Test..............................................11 
2.4. Saving the Test Session........................................................11 
3 Reporting...................................................................................12 
4 Calibration Verification .............................................................. 13 
5 Configuration Options................................................................ 15 
Power Management ........................................................................... 17 
1 Batteries....................................................................................17 
2 Power Save Mode..................................................................... 18 
Cleaning & Hygiene............................................................................ 18 
1 Preventing Cross-Contamination of Subjects............................ 18 
2 Inspection of the Micro Spirometer............................................19 
Remote Flowhead ..............................................................................20 
Fault Finding Guide............................................................................ 20 
1 Software Check.........................................................................21 
2 Product Useful Life Checks.......................................................21 
Customer Service.............................................................................22 
Consumables and Accessories.......................................................... 22 
Disposal........................................................................................... 22 
Explanation of Symbols...................................................................23 
Description of the Micro Spirometer.................................................24 
Technical Specifications................................................................... 24 
CE Notice......................................................................................... 26 
FDA Notice......................................................................................28 
EU Declaration of Conformity..........................................................29 
Guarantee ........................................................................................ 30 
 

1. Indications for Use

The device is a spirometer which measures a subjects respiratory

parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Micro

Spirometer is a handheld spirometer designed for lung function testing for

use on adults and pediatrics, 5 years and older, in a variety of

environments such as hospital wards, health centers and private homes

under the supervision of a healthcare provider.

2. Contraindications, Warnings, Precautions and

Adverse Reactions

1. No modification of this equipment is allowed. Any unauthorized

changes to the device may compromise product safety and/or

data and as such the manufacturer cannot be held responsible

and the device will no longer be supported.

2. The Micro Spirometer is not designed as a sterile device. Always

follow the safety guidelines given by the manufacturer of

cleaning and disinfectant chemicals.

3. 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. A SpiroSafe filter is for single use only.

4. Spirometry may support or exclude diagnosis but it cannot make

one (ATS/ERS 20191).

5. The device is marked as “Rx Only”and therefore may only be

sold in the USA by or on the order of a physician.

6. When using the remote flowhead ensure that the flowhead

connecting tube is not pinched or trapped as spirometry results

may be affected, or a false reading may be detected.

7. The USB cable supplied with the device has the potential to be a

strangulation hazard and therefore should be kept out of the

reach of children and pets.

8. The device is rated to IP22 which protects it from solids >12.5

mm and dripping water however it is not designed to be

waterproof. Do not get the device wet or use it in a wet

environment (e.g., in the rain, in the shower). If the device does

get wet, it may cease to function however there is no safety risk

or potential harm to the user. If the device does get wet, contact

the device manufacturer.

1ATS/ERS Standardization of Spirometry Eur Respir J2019

9. 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. Subject

may also take a break between tests. The maximum number of

efforts for each of the test modules (SVC, FVC and Post) on the

Micro Spirometer is 20 maneuvers.

11. All values displayed are expressed as BTPS values.

12. Time zero is determined using the back-extrapolated method,

from the steepest part of the curve.

13. The Micro Spirometer should not be used in the presence of

flammable liquids or gases, dust, sand or any other chemical

substances.

14. All spirometry standards recommend completing a calibration

verification of lung function measuring devices daily with a 3-L

syringe to validate the 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 adjusting calibration or if the

flowhead or device has been dropped.

15. Service and repairs should be carried out only by the

manufacturer or by Service Agents specifically approved by the

manufacturer.

16. Maintenance must not be performed while the device is in use

by a subject.

17. Do not disconnect the device or USB cable from the computer

running the software during data transfer or printing.

18. The device contains a lithium coin cell battery which is not

accessible by the user. Any suspected battery faults should be

reported to the manufacturer.

19. The device uses 4x 1.5V non-rechargeable IEC60086 certified

AAA alkaline batteries.

20. The AAA batteries should be removed if the Micro Spirometer is

intended to be stored, without use, for an extended period.

21. When replacing the batteries all four should be replaced

together, use batteries from the same manufacturer, never mix

new and old batteries, make sure all four batteries are inserted

in the correct orientation.

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.

23. Use of accessories and cables other than those specified or

provided by the manufacturer for this equipment could result in

increased electromagnetic emissions or decreased

electromagnetic immunity of the device and result in improper

operation.

24. Non-medical equipment must be kept outside the subject

environment i.e., any area in which intentional or unintentional

contact between the subject and parts of the system, or some

other persons touching part of the system, can occur.

25. Portable RF communications equipment (including peripherals

such as antenna cables and external antennas) should be used

no closer than 30 cm (12 inches) to any part of the device,

including cables specified by the manufacturer. Otherwise,

degradation of the performance of this equipment could result.

26. Use of this equipment 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 to verify they are operating

normally.

27. Avoid exposure to known sources of EMI (Electromagnetic

Interference) such as diathermy, lithotripsy, electrocautery, RFID

(Radio Frequency Identification), and electromagnetic security

systems such as anti-theft/electronic article surveillance

systems, metal detectors. Note that the presence of RFID

devices may not be obviously. If such interference is suspected,

reposition the equipment, if possible, to maximize distances.

28. This device is ‘MR Unsafe’do not use it in an MRI environment.

29. The applied part is the flowhead and device body. These, along

with the SpiroSafe Filter, are the contact points for the subject

during a spirometry session. There are no adverse effects if the

subject comes into contact with any other part of the device.

3. Main Components of the Micro Spirometer

The Micro is a standalone spirometer. Device Studio software allows the

Micro Spirometer to generate reports to a computer after testing is

complete but is not required for the device to function.

The main components of the Micro Spirometer are:

Figure 1 The main components of the Micro Spirometer

Note: Computer Shown for illustration purposes only and not supplied.

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)

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

1. Insert 4 x 1.5V AAA batteries into the battery compartment.

2. Alternatively, the device may be powered using the USB cable

supplied. Connect one end of the USB cable into a USB port on a

computer and the other end into the micro-USB connector on the

device.

3. Press the On/Off switch to turn the device on.

4. Install Device Studio on the computer following instructions

supplied with the software.

5. To use Device 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, fully powered and is at room temperature prior to testing.

Ensure a calibration verification is completed on each testing day, prior to

using the device (see Section 5.4 Calibration Verification).

If using with the with the remote flowhead (not included as standard):

1. Remove the flowhead from the main body of the device by gripping

and sliding it firmly in the direction of the flowhead cone (6).

2. Connect the remote flowhead adapter (4) to the base of the

flowhead (5), connect the device cap (2) to the device (1).

3. Unwrap the flowhead connection tubing (3) and connect one end

to device cap (2) and the other end to the remote flowhead adapter

(4). See Figure 2. The tubing is keyed, so it will only connect one

way.

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.

Continue to the temperature entry screen . Enter the temperature.

Press the forward icon to save.

Continue to the Maine Menu screen which including the following options:

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. V –indicates a VC test has been performed

2. F –indicates an FVC has been performed

3. P –indicates a Post test has been performed.

5.1 Entering Subject Data

1. Select New Subject on the Main Menu.

2. The available information fields available are: Date of Birth

, Height , Birth Sex , Weight , Population .

Weight and Population Group 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 touchscreen

keyboard. Use the keyboard to enter the information. Units will

automatically switch between cm/kg and in/lbs.

4. Select Birth Sex by pressing the male or female icon.

5. Select Population Group by pressing the appropriate option on

the screen. Use the select arrow on the right of the screen to

access additional Population Groups.

6. Press the forward button to save the subjects details.

7. If a value is not entered for Birth Sex, Height or Date of Birth, an

Error Icon will appear next to the empty field. If the

information is not entered then the predicted values will not

appear in test results.

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