Micro Direct SpiroUSB Manuel utilisateur
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.
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