NIOX 09-1000, Руководство пользователя, Страница: 22 / 24

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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.
1
Am J Respir Crit Care Med 2005; 171: 912-930.
2
Alving K, Jansson C, Nordvall L: Performance of
a new hand-held device for exhaled nitric oxide
measurement in adults and children. Respiratory
Research 2006;7:67-5.
3
McGill C, Malik G, Turner S. Validation of
a hand-held exhaled nitric oxide analyzer
for use in children. Pediatr Pulmonol. 2006
Nov;41(11):1053-7.
4
Khalili B, Boggs PB, Bahna SL. Reliability of a
new hand-held device for the measurement of
exhaled nitric oxide. Allergy 2007;62:1171-1174.
5
Menzies D, Nair A, Lipworth BJ. Portable
exhaled 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.
Vigilance
Circassia, as a medical device manufacturer,
must have a system in place to report to health
authorities, any adverse incidents that have
occurred with its medical products, a so-called
Vigilance system.
The purpose of the Vigilance system is to ensure
the health and safety of patients, users and
others using medical products by reducing the
likelihood of the same type of adverse incident
being repeated. This is achieved by immediate
notification of incidents to enable corrective and
preventive actions.
An adverse incident is defined as: Any malfunction
or deterioration in the characteristics and/or
performance of a device, or any inadequacy in the
labelling or instructions for use which might lead
to or might have led to the death of a patient or
user or to a serious deterioration in his/her state of
health.
Manufacturers of medical devices are obliged
to report adverse incidents to national health
authorities within 10 or 30 days, dependent on the
severity of the incident.
Any user of Circassia's products, who experience
an adverse incident related to the product, must
therefore immediately report this to Circassia or
Circassia's local market representative. The report
can be made by e-mail, fax, or telephone.
The report should contain the following information:
• When and where did the incident occur?
• What product / accessory was involved?
• Was the incident related to instructions for use of
the product?
• Was the risk foreseeable and clinically acceptable
in view of potential patient benefit?
• Was the outcome adversely affected by a
patient's pre-existing condition?
The report should be forwarded to Circassia's local
representative in the country where the incident
occurred.