2
Warning!
• Handle the NIOX MINO
®
instrument as
stated in this manual. Circassia accepts no
responsibility for damaged equipment or
faulty results if the equipment is not handled
according to this manual.
• Do not use a damaged NIOX MINO instrument
or damaged components.
• Use only the power supply unit provided.
• Keep the instrument out of water. Ensure
that no liquid is spilled or dripped on the
instrument.
• Do not heat or dispose of the instrument or
Sensor in fire. Please refer to the "Disposal of
used/expired products" section.
• Take care not to drop the instrument or subject
it to strong impact.
• It is recommended not to use NIOX MINO
in the proximity of areas where volatile
substances such as organic fluids or
disinfectants are being used. Special attention
should be paid to aerosols and disinfection
baths (either open vessels or ultrasonic baths).
• NIOX MINO should not be used adjacent to or
stacked with other equipment.
• The NIOX MINO Sensor contains chemicals
that could be harmful if swallowed.
• Touch only the grey cap when exchanging the
Sensor.
• Do not clean the Sensor. Cleaning of the
Sensor with ethanol or similar disinfectant
might destabilize it for a non-predictable time
period.
• Keep the Sensor out of water. Ensure that no
liquid is spilled or dripped on the Sensor.
• The NO scrubber contains potassium
permanganate and should be disposed of as
hazardous waste in accordance with the local
waste disposal regulations.
•
When selecting an accessory for your
NIOX MINO please keep in mind that an
accessory not recommended by Circassia
may result in loss of performance, damage to
your NIOX MINO, fire, electric shock, injury
or damage to other property. The product
warranty does not cover product failure or
damage resulting from use with non-approved
accessories. Circassia takes no responsibility
for health and safety problems or other
problems caused by the use of accessories
not ap proved by Circassia.
• No modification of the NIOX MINO instrument
or the Sensor is allowed.
Also see Cautions page 19.
Intended use (Europe)
NIOX MINO
®
Airway Inflammation Monitor
measures Fractional Exhaled Nitric Oxide (
FeNO
)
in human breath. The level of Nitric Oxide is
elevated when eosinophilic airway inflammation
is present and decreases as a response to anti-
inflammatory treatment. The
FeNO concentration
in expired breath can be measured by NIOX MINO
with assurance that such measurements are
repeatable and according to guidelines for NO
measurement established jointly by the European
Respiratory Society and the American Thoracic
Society
1
.
Measurement of FeNO by NIOX MINO is a
quantitative, non-invasive, simple and safe method
to measure the FeNO concentration in patients
with asthma-like airway symptoms in order to
establish and monitor the presence of eosinophilic
airway inflammation.
NIOX MINO is suitable for children, approximately
4 - 17 years, and adults 18 years and older.
FeNO measurements should be used as part
of the regular assessment and monitoring of
asthma patients to improve the patient’s asthma
management. NIOX MINO should be used
as directed in the NIOX MINO User Manual.
NIOX MINO may not be used with infants or by
children approximately under the age of 4, as
measurement requires patient cooperation.
1
Am J Respir Crit Care Med 2005; 171: 912-930.
Training requirements
NIOX MINO should only be used as directed in this
manual, by trained physicians, nurses, respiratory
therapists and laboratory technicians. “Trained”
status is achieved only after careful reading of this
manual.