Cautions; Clinical Documentation - Aerocrine NIOX MINO Manuel De L'utilisateur

E N G L I S H

Cautions

• Mobile phones and cordless phones might
interfere with the instrument and should
therefore be kept away from the instrument.
Interference could make it impossible to perform
a measurement.
• Make sure that you use the required measurement
mode, otherwise incorrect exhaled NO results
might be obtained.
• Use of substances containing alcohol close to
NIOX MINO may cause erroneous measurement
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results.
• Do not reuse the NIOX
• The NIOX MINO instrument might produce some
heat during normal operation, the temperature
could increase up to 5°C above the ambient
temperature. Make sure that the base ventilation
slots are not blocked. Do not place the instrument
on a bed, sofa, carpet, or other soft surface.
• A maximum of 10 measurements/hour can be
performed during continuous use. How ever, it will
be possible to perform 20 measurements per hour
if the instrument is allowed to rest for a minimum
of 30 minutes after that.
• The Special 6 s. exhalation and nasal modes are
intended for research use only.
• The NIOX MINO Sensor shall be kept in its
original unopened package before installation. For
transportation and storage conditions, refer to the
corresponding section in this manual.
• The NIOX MINO Sensor is sensitive to changes in
ambient temperature and humidity.
• Be careful when opening the Sensor can. The
inside of the opening has sharp edges. Do not
touch or clean the white Sensor membrane.
•Best performance is achieved if the ambient
conditions are stable. Refer to the "Operating
conditions" section. Keep the instrument away
from windows, sunshine, radiators, stove or open
fire in order to avoid unstable conditions. When
transporting the instrument from one location to
another, a prolonged stabilization period before
measurement might be required. Refer to the
recommended transportation conditions in the
"Transport and Storage" section. Always use a
NIOX MINO Bag for transportation. Keep the
NIOX MINO with mounted Sensor connected to
the power outlet whenever possible.
•NIOX MINO has been tested and found to
comply with the limits for medical devices
according EN/IEC 60601-1 Safety requirements for
medical electrical systems and electromagnetic
compatibility. These limits are designed to
provide protection against harmful interference
in a typical medical installation. However,
because of the increased use of radio-frequency
transmitting equipment and other sources of
electrical noise emitters in the health-care and
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Filters.
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home environments, such as base stations for
radio, cellular/cordless telephones and land
mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast, it is possible that high
levels of such interferences due to close proximity
or strength of a source, may result in disruption
of performance of the device. If abnormal
performance is observed, it may be necessary to
reorient or relocate NIOX MINO.
•A PC connected to the USB connector has to be
certified for one of the standards IEC 60601-1, IEC
61010-1, IEC 60950 or comparable with safety
extra low voltage on the USB ports.
•The connected PC should be placed out of reach
from the patient. Do not, simultaneously, touch the
connected PC and the patient.

Clinical documentation

NIOX MINO follows the American Thoracic Society
(ATS) and European Respiratory Society (ERS) 2005
equipment recommendations for measurement of
exhaled NO.
1
The recommendations are based on analysis
of NO with the chemiluminesence method.
However, NIOX MINO is using a different method
(electrochemistry). One consequence of this is that
the NIOX MINO Sensor does not need any field
calibration*. Agreement has been demonstrated for
the mean of two valid exhaled NO measurements
in NIOX and the first valid NO measurement in
NIOX MINO.
2-5
Supported by these data, one valid NO
measurement should be considered sufficient,
instead of two as recommended in the guideline.
Am J Respir Crit Care Med 2005; 171: 912-930.
1
Alving K, Jansson C, Nordvall L: Performance of
2
a new hand-held device for exhaled nitric oxide
measurement in adults and children. Respiratory
Research 2006;7:67-5.
McGill C, Malik G, Turner S. Validation of
3
a hand-held exhaled nitric oxide analyzer
for use in children. Pediatr Pulmonol. 2006
Nov;41(11):1053-7.
Khalili B, Boggs PB, Bahna SL. Reliability of a new
4
hand-held device for the measurement of exhaled
nitric oxide. Allergy 2007;62:1171-1174.
Menzies D, Nair A, Lipworth BJ. Portable exhaled
5
nitric oxide measurement: Comparison with the
"gold standard" technique. Chest 2007;131(2):410-
4.
* The Sensor is already calibrated during
manufacturing and does not need to be re-
calibrated.