Vigilance; Guidance And Manufacturer's Declaration; Electromagnetic Emissions - Aerocrine NIOX MINO Manuel De L'utilisateur

Vigilance

Aerocrine, 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 Aerocrine's products, who experience
an adverse incident related to the product, must
therefore immediately report this to Aerocrine or
Aerocrine'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 Aerocrine's local
representative in the country where the incident
occurred.
Guidance and manufacturer's
declaration

Electromagnetic emissions

Caution!
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 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.
Warning!
NIOX MINO should not be used adjacent to
or stacked with other equipment.
Adjacent or stacked use together with NIOX
Nitric Oxide Monitoring System has been tested by
Aerocrine and proven as acceptable.
The technical description on the electromagnetic
immunity test levels and electromagnetic
environment guidance can be found on
www.niox.com.
E N G L I S H
®
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