Chapter 1 Important information
4 000191-16 NIOX VERO
®
User Manual English
• When selecting an accessory for your NIOX VERO® product keep in mind
that an accessory not recommended by Circassia may result in loss of
performance, damage to your NIOX VERO® product, 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
approved by Circassia.
• NIOX VERO® should not be used adjacent to or stacked with other
electronic equipment.
• Only use the power supply provided. Pull the plug when disconnecting
NIOX VERO® from the power outlet.
• Use only the breathing handle supplied by Circassia.
• No modification of NIOX VERO® instrument, handle or sensor is allowed.
• Do not drop the instrument or subject it to strong impact.
• Do not use a damaged NIOX VERO® instrument or damaged
components.
• Keep the instrument and sensor out of water. Ensure that no liquid is
spilled or dropped on the instrument or sensor.
• Do not heat or dispose of the instrument or sensor in fire. Refer to section
8.4, Disposal of instrument and accessories.
• NIOX VERO® and the NO scrubber in the breathing handle contains
potassium permanganate. Used or expired instruments and breathing
handles should be disposed of as hazardous waste in accordance with
local waste disposal regulations.
• The breathing handle must not be used after expiration date.
• Patient filters should be used immediately after opening.
• NIOX VERO® Sensor contains chemicals that could be harmful if
swallowed.
• Be careful when opening the sensor can. The inside of the opening may
have sharp edges.
• Do not touch or clean the white sensor membrane.
• After inserting a new sensor it is recommended to wait for three hours
with the instrument switched on before performing a measurement.
• Make sure to use the correct measurement mode, otherwise incorrect
FeNO results might be obtained.
• Patient filters are labeled for single use only. Always use a new patient
filter for each patient. Reuse between patients could increase the risk of
cross-contamination or cross-infection. The same filter can be reused in
one patient for multiple attempts in the same session.
• Do not use NIOX VERO® 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. Do not use the instrument in the presence of
flammable anesthetic, vapors or liquids.
1.6 Intended use
NIOX VERO® measures Nitric Oxide in human breath (Fractional exhaled
Nitric Oxide, FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from the
nasal cavity. NIOX VERO® is for use only as an In Vitro Diagnostic Device (IVD)
and intended for near patient testing.
FeNO
FeNO is increased in some airway inflammatory processes such as asthma
and decreases in response to anti-inflammatory treatment. FeNO
measurement with NIOX VERO® is quantitative, non-invasive, simple, safe
and is used as part of assessment, and monitoring of patients with these
conditions. NIOX VERO® is suitable for patients age 4 and above for FeNO
measurements.
As measurement requires patient cooperation, some children below the age
of 7 may require additional coaching and encouragement. NIOX VERO®
should be used as directed in the NIOX VERO® User Manual.
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