Chapter 9 Safety information
38
000190-09 NIOX VERO
®
User Manual US
order to avoid unstable conditions.
•
When transporting the unit 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 on page 45. Always use a bag for transportation.
•
Make sure that the gas outlet (four parallel slots to the left of the lid) on
the rear side of the device is not covered.
•
The device contains a Lithium-ion Battery which may induce an
increased risk of heat, smoke or fire if handled incorrectly; do not open,
crush, heat above 140°F or incinerate.
•
Keep the Sensor out of reach of children.
•
Any person who connects external equipment to signal input and signal
output ports of this device has formed a Medical Electrical System and is
therefore responsible for the system to comply with the requirements of
IEC 60601-1.
•
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.
9.3
Substances disturbing FeNO measurement
Known patient factors that could interfere with FeNO measurements are de-
scribed in the ATS Guidelines (Am j Respir Crit Care Med 2005; 171:912-
930) as follows:
To assure correct results when performing FeNO measurement with
NIOX VERO
®
, the following cautions apply:
•
Respiratory maneuvers
- Because spirometric maneuvers have been
shown to transiently reduce exhaled NO levels, it is recommended that
NO measurement be performed before spirometry. The same stipulation
applies to other taxing respiratory maneuvers, unless these can be
shown not to influence exhaled NO. The FeNO maneuver itself and body
pletysmography do not appear to affect plateau exhaled NO levels.
•
Age/sex
- In adults there is no consistent relationship between exhaled
NO level and age, but it has been reported that, in children, FeNO
increases with age. In Adults, there are conflicting reports regarding the
effects of sex, menstrual cycle and pregnancy, so these patient
characteristics should be recorded at the time of measurement.
•
Airway caliber
- It has been demonstrated that FeNO levels may vary
with the degree of airway obstruction or after bronchodilatation, perhaps
because of a mechanical effect on NO output. Depending on setting, it
may be prudent to record the time of last bronchodilator administration
and some measure of airway caliber, such as FEV.
•
Food and beverages
- Patients should refrain from eating and drinking
before NO analysis. An increase in FeNO has been found after the
ingestion of nitrate or nitrate-containing foods, such as lettuce (with a
maximum effect 2 hours after ingestion) and drinking of water and
ingestion of caffeine may lead to transiently altered FeNO levels. Until
more is known, it is prudent when possible to refrain from eating and
drinking for 1 hour before exhaled NO measurements and to question
patients about recent food intake. Alcohol ingestions reduces FeNO in
patients with asthma and in healthy subjects.
•
Circadian rhythm
- Although FeNO levels are higher in nocturnal
asthma, there was no circadian rhythm in two studies, but another study
did report a circadian pattern, so it is uncertain whether measurements
need to be standardized for time of day. It is, however, prudent, where
possible, to perform serial NO measurements in the same period of the
day and to always record the time.
•
Smoking
- Chronically reduced levels of FeNO have been demonstrated
in cigarette smokers in addition to acute effects immediately after
cigarette smoking. Despite the depressant effect of smoking, smokers
with asthma still have raised FeNO. Subjects should not smoke in the
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