Micro Direct SpiroUSB User manual

SpiroUSB 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
075-11 US
Issue 1.6
February 2019
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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
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

Contents
Introduction................................................................................ - 1 -
Package Contents ..................................................................... - 2 -
Contraindications....................................................................... - 3 -
Warning and Cautions............................................................... - 3 -
Indications for Use..................................................................... - 5 -
Installing SPCS.......................................................................... - 5 -
Installing SpiroUSB Device Driver............................................. - 5 -
Compatibility Status................................................................... - 5 -
Driver installation ....................................................................... - 6 -
Operation................................................................................... - 6 -
Calibration Check ...................................................................... - 7 -
Cleaning Instructions................................................................. - 9 -
External Surfaces of the Spirometer.......................................... - 9 -
Cleaning Accessories ................................................................ - 9 -
Cleaning the Transducer ......................................................... - 10 -
Servicing.................................................................................. - 11 -
Product Lifetime....................................................................... - 11 -
Trouble Shooting Information .................................................. - 12 -
Safety Designation per IEC 60601-1....................................... - 13 -
Electromagnetic Compatibility (EMC) to EN60601-1:2007 ..... - 14 -
Symbols................................................................................... - 20 -
Specification of the SpiroUSB ................................................. - 21 -
Spirometry Measurements....................................................... - 22 -
Consumables / Supporting Products....................................... - 23 -
Customer Contact Information................................................. - 24 -
ICD-10 Codes for Spirometry .................................................. - 25 -

1
Introduction
The SpiroUSB is a PC connected spirometer dedicated
to work with the comprehensive Spirometry PC
Software (SPCS).
SPCS is a fully Windows™ compatible spirometry
system that interfaces seamlessly with the SpiroUSB
providing many display options and includes powerful
reporting and database facilities.
SPCS has many advanced features including display of
real time respiratory traces, predicted values, patient
database, and the ability to carry out pre and post
bronchodilator and post steroid testing.
The SpiroUSB uses a Gold Standard 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
Package Contents
The SpiroUSB is packaged in a sturdy carrying case
containing this manual and the following items (Fig.1):
1. Digital Volume Transducer
2. SpiroUSB transducer housing.
Together with SPCS, extension cable, disposable
cardboard mouthpieces and nose clip.
2
1

3
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.

4
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.
CAUTION: Mouthpieces are single patient use. If used on more
than one patient, there is a risk of cross-infection. Repeat use may
degrade materials and lead to an incorrect measurement.
CAUTION: Pulmonary filters are single patient use. If used on
more than one patient, there is a risk of cross-infection. Repeat
use may increase air resistance and lead to an incorrect
measurement.
PLEASE NOTE: The product you have purchased
should not be disposed of as unsorted waste. Please
utilize your local recycling facility for the disposal of this
product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
WARNING: To avoid risk of electric shock, this equipment must
only be connected to a supply mains with protective earth.
CAUTION: When you connect the SpiroUSB to other equipment,
always make sure that the whole combination complies with the
international safety standard IEC 60601-1 for medical electrical
systems. During measurements, connect the SpiroUSB only to
printers and computers that comply with IEC 60601-1 /
ANSI/AAMI ES60601-1:2005 / CAN/CSA-C22.2 No. 60601-1:14.

5
Indications for Use
The SpiroUSB 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.
Installing SPCS
SPCS is supplied on the CD ROM with your SpiroUSB.
Install SPCS according to the instructions in the SPCS
quick start guide.
Installing SpiroUSB Device Driver
The driver enables the SpiroUSB devices to work with
USB enabled PC software on Windows based
machines.
Compatibility Status
There are two versions of the USB driver. The driver
used depends on the Operating System you are using.
There is a driver for Windows 32 bit Operating Systems
and for 64 bit.
The following operating systems are supported:
•Windows 7 32 & 64-bit Operating Systems
•Windows 8.1 32 & 64-bit Operating Systems
•Windows 10 64-bit Operating System

6
The driver will not be supported under older Windows
Operating Systems.
Driver installation
If software is installed that provides support for USB,
the drivers may be pre-installed, allowing automatic
installation of the drivers when the device is connected
to the USB port. If the device does not install
automatically, contact Micro Direct at 800-588-3381 to
request a link for the drivers.
Operation
Simply connect the SpiroUSB to a spare USB port on
your PC with the supplied SPCS installed. SPCS will
automatically detect the SpiroUSB has been connected
to a USB port and will run, ready for you to start your
spirometry session. There is no need to remove the
SpiroUSB between sessions.
Please note that with certain PC configurations, even if
a compatible operating system is being used, SPCS
may not be launched automatically when the SpiroUSB
is plugged in. In this case, SPCS may be run in the
usual way using the Windows on-screen Start button.
The SpiroUSB transducer is supplied with a 6.5-foot
cable. If this length is insufficient then a remote USB
hub should be used. Remote USB hubs are readily
available from computer accessory suppliers. For
some recent computers, the USB signal will work over
a longer distance using an extension cable. An
extension cable has been supplied for your
convenience. If communication problems are

7
encountered using the extension cable, then a remote
USB hub must be used.
Note: Keep the PC and monitor out of reach of the
patient at all times.
Looking after your SpiroUSB Spirometer
Please observe the following precautions:
•Avoid exposing the SpiroUSB to direct sunlight
during use.
•Avoid operating the spirometer in dusty conditions
or near to heating appliances or radiators.
•Do not keep the spirometer in a damp place or
expose it to extreme temperatures.
•Do not direct the transducer holder towards a strong
light source while operating the spirometer.
Calibration Check
The spirometer is calibrated to read in liters at body
temperature, barometric pressure saturated with water
vapor (BTPS).
The calibration should remain stable indefinitely unless
the transducer is physically damaged, and the unit
should not require re-calibration. However, to ensure
the correct functioning of the unit, we do recommend a
calibration check is performed after the transducer is
removed for cleaning.

8
Pressing the ‘Verify Calibration’ button in the SPCS
invokes the start of a device search and the option
Calibration Check. The device search effectively scans
the PC’s com/usb ports for any attached device. On
finding a device, the screen will change to the main
verify calibration test screen. The option to perform an
expiratory only or an expiratory and inspiratory
calibration check and a single volume calibration or
more advanced calibration check at three separate flow
rates can be chosen in the calibration screen.
Connect a 3-liter syringe to the transducer with the
minimum of adapters and empty it by pushing the
handle fully in.
Note: It is recommended that the transducer is
disinfected prior to a calibration check or a SpiroSafe
filter is used during the procedure.

9
Cleaning Instructions
Disinfection of contaminated parts is only effective after
having them carefully pre-cleaned. Please follow the
solution manufacturer’s instructions.
The device must not be exposed to solvents e.g.
alcohol, chlorine
CAUTION: Unplug your SpiroUSB before cleaning.
External Surfaces of the Spirometer
CAUTION: Do not attempt to wash or immerse the
SpiroUSB transducer housing in water or cleaning fluid
as there are electronic components inside that will be
permanently damaged.
The external housing of the spirometer may be wiped
with sterile wipes or a damp cloth that has been
immersed in a cold sterilizing solution when required.
We recommend the Protex Disinfectant wipe (see
consumables / supporting products)
Cleaning Accessories
With the use of a SpiroSafe filter (#3385) or a
MicroCheck one-way valve mouthpieces (#3395) for
each patient, cleaning for the components in patient’s
gas path is recommended once a month.
When using the disposable cardboard mouthpiece
(adult #3314SB/#3314B5 or pediatric #3301) without a
filter under the prerequisite that the patient was
instructed only to exhale into the transducer, the

10
following parts must be cleaned once a day: adapter
(pediatric/adult) and the transducer.
With any other use as described above all
contaminated parts must be disinfected between
patients.
Important Note: Used single patient nose clips,
mouthpieces and SpiroSafe filters must be disposed of
immediately after the use.
If there are changes on the material surfaces (cracks,
brittleness), the respective parts must be disposed of.
Cleaning the Transducer
The transducer requires no routine maintenance or
servicing. However, if you wish to disinfect or clean the
transducer it may be removed by means of the
following procedure:
1. Rotating the turbine transducer anti-clockwise
until the locating pip lines up with the small
rectangular cut-out in the housing as on the next
page.
2. Gently pull the transducer away from the
housing.
3. The transducer may now be immersed in warm
soapy water for routine cleaning or immersed in
a cold disinfectant solution for a maximum of 10
minutes (Alcohol and chlorine solutions should
be avoided).
4. After cleaning/disinfecting, the transducer should
be rinsed briefly in distilled water and dried.

11
Locatingpip
Turbinetransducer
Housing
Cut-out
5. Re-assemble the mouthpiece holder.
CAUTION: Do not attempt to wash or immerse the
SpiroUSB transducer housing in water or cleaning fluid,
as there are electronic components inside that will be
permanently damaged.
Servicing
A full-service manual including circuit diagrams and
parts list is available upon request.
If your unit requires service or repair, please see page
23 for contact details.
Product Lifetime
The SpiroUSB spirometer is designed for a product
lifetime of 5 years.

12
Trouble Shooting Information
Should you encounter problems operating your
SpiroUSB Spirometer, please consult the table below:
Problem
Possible Cause
Solution
Does not
register a blow
Head assembly
or cable broken
Replacement of head
assembly or return the unit
for servicing
Blows are
inverted on the
display
Head assembly
or cable broken
Replacement of head
assembly or return the unit
for servicing
Blows tracking
ends abruptly
although patient
is still exhaling
Turbine sticking
Clean turbine in warm
soapy water or disinfecting
solution, if problem
continues a replacement
turbine may be required
Calibration
procedure failed
or cannot be
completed
Turbine may be
faulty
Repeat calibration
procedure, if problem
persists, replace turbine or
return unit for servicing
Turbine not fitted
tightly to
calibration
syringe
Ensure the syringe is fitted
to the turbine using an
adapter if needed
Calibration
syringe does not
have an
inspiratory seal
or seal is leaking
Check with syringe
manufacturer to confirm
syringe is operating
properly
Shaft of the
syringe is being
pushed down
The syringe should be
emptied and filled with one
smooth stroke, avoid
pushing down on the shaft
or banging at the end of
each maneuver.

13
Safety Designation per IEC 60601-1
Type of protection against
electrical shock
Powered by
computers that
comply with IEC
60601-1 /
ANSI/AAMI
ES60601-1:2005 /
CAN/CSA-C22.2
No. 60601-1:14.
Degree of protection against
electrical shock
Type B applied part
Power Equipment
Powered by
computers that
comply with IEC
60601-1 /
ANSI/AAMI
ES60601-1:2005 /
CAN/CSA-C22.2
No. 60601-1:14.
Degree of Electrical connection
between equipment and patient
Equipment
designed as non-
electrical
connection to the
patient
Degree of mobility
Transportable
Mode of operation
Continuous
Classifications according to IEC 60601-1
SpiroUSB
Applied part, type B
Volume Transducer
Applied part, type B

14
WARNING: No modification of this equipment is
allowed.
CAUTION: When you connect other equipment to the
unit, always make sure that the whole combination
complies with the international safety standard IEC
60601-1 for medical electrical systems. During
measurements, connect the SpiroUSB only to
computers that comply with IEC 60601-1 / ANSI/AAMI
ES60601-1:2005 / CAN/CSA-C22.2 No. 60601-1:14.
WARNING: The user must not touch any voltage
carrying parts and the patient at the same time or the
operator must not create a “bridge” between the device
I/O ports and the patient by simultaneously touching
both.
WARNING: Do not connect devices that are not
specified as part of the system.
WARNING: To avoid risk of electric shock, this
equipment must only be connected to supply mains
with protective earth.
Electromagnetic Compatibility (EMC) to EN60601-
1:2007
WARNING: use of portable phones or other radio
frequency (RF) emitting equipment near the system
may cause unexpected or adverse operation.
The SpiroUSB has been tested to EN60606-1-2:2007,
regarding the ability to operate in an environment
containing other electrical/electronic equipment
(including other medical devices).

15
The purpose of this testing is to ensure that the
SpiroUSB 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 SpiroUSB.
Despite the testing of the SpiroUSB that has been
undertaken, normal operation of the SpiroUSB can be
affected by other electrical/electronic equipment and
portable and mobile RF communications equipment.
As the SpiroUSB is medical equipment, special
precautions are needed regarding EMC
(electromagnetic compatibility).
It is important that the SpiroUSB is configured and
installed /put into service, in accordance with the
instructions/guidance provided herein and is used only
in the configuration as supplied.
Changes or modifications to the SpiroUSB may results
in increased emissions or decreased immunity of the
SpiroUSB in relation to EMC performance.
The SpiroUSB should be used only with the USB
extension cable provided by Micro Direct, which is
referenced in the accessories section of this manual.
This cable should not be used with devices other than
the SpiroUSB. If the cable is extended by the user
using non-approved cables, this may result in an
increased level of emissions or decreased level of
immunity, in relation to the SpiroUSB’s EMC. Use of
the USB extension cables with devices other than the
SpiroUSB, may result in an increased level of

16
emissions or decreased level of immunity, in relation to
the other devices’ EMC.
The SpiroUSB has an essential performance –the
product should continue to operate correctly. In the
unlikely event of a Fast Transient / ESD event
occurring, the device should be reset and located away
from the source of interference.
WARNING: The SpiroUSB should not be used adjacent
to or stacked with other equipment. If adjacent or
stacked use with other equipment is necessary, the
SpiroUSB and the other equipment should be
observed/monitored, to verify normal operation in the
configuration in which it will be used.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The SpiroUSB is intended for use in the electromagnetic environment specified
below. The customer or the user of the SpiroUSB should assure that it is used in
such an environment
Emission Test
Compliance
Electromagnetic Environment -
Guidance
RF emissions
CISPR 11
Group 1
The SpiroUSB uses RF energy only 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
Group B
The SpiroUSB is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes
Harmonic emissions
IEC61000-3-2
Not Applicable
(USB powered)
Voltage fluctuations /
flicker emissions
IEC61000-3-3
Not Applicable
(USB powered)
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SpiroUSB is intended for use in the electromagnetic environment specified
below. The customer or the user of the SpiroUSB should assure that it is used in such
an environment.

17
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment -
Gudiance
Electrostatic
discharge (ESD)
IEC61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least
30%
Electrical fast
transient / burst
IEC61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for input /
output lines
Supply line tests
not applicable
+/- 1 kV for
USB Lead
Mains power quality
should be that of a
typical commercial or
hospital environment
Surge
IEC61000-4-5
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to
earth
Not Applicable
(USB Powered)
Mains power quality
should be that of a
typical commercial or
hospital environment
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC61000-4-11
< 5% UT
(> 95% dip in UT)
For 0.5 cycle
40% UT
(60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles <5% UT
(> 95% dip in UT)
for 5 s
Not Applicable
(USB Powered)
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of the
SpiroUSB requires
continued operation
during power mains
interruptions, it is
recommended that
the SpiroUSB be
powered from an
uninterruptible power
supply or a battery
Power frequency
(50/60 Hz)
Magnetic field
IEC61000-4-8
3 A / m
3 A / m
If incorrect operation
occurs, it may be
necessary to position
the SpiroUSB further
from sources of power
frequency magnetic
fields or to install
magnetic shielding.
The power frequency
magnetic field should
be measured in the
intended installation
location to assure that
it is sufficiently low.
NOTE UTis the a.c. mains voltage prior to application of the test level.