A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y
MyLab
- G E T T I N G S T A R T E D
2 - 16
The probe and electrode materials that are in contact with patients, comply with
the applicable requirements of EN ISO 10993-1, according to their intended use.
No negative reactions to these materials have been reported.
Latex Sensitive Patient
The USA Food and Drug Administration (FDA) has issued an alert on products
composed of latex, because of reports of severe allergic reactions.
NOTE
Esaote probes do NOT contain latex
WARNING
The probe protective covers used during the patient exam are usually made
of latex. Carefully read the protective cover package labeling to check the
material used. Be certain to identify latex sensitive patients before starting
the exam. Serious allergic reactions to latex have been reported and the user
should be ready to react accordingly (for further information refer to the
FDA Medical Alert, March 29, 1991, “Allergic Reactions to Latex-
Containing Medical Devices”). For additional information in the U.S.A.,
refer to FDA Medical Alert MDA91-1.
Device Modifications
Esaote is not responsible for any unauthorized modification of equipment
(including cables) and/or probes.
CAUTION
Do not modify any Esaote equipment without authorization. Always refer
to Esaote personnel for authorized modifications of the device.
If the equipment has been modified, appropriate inspections and testing
must be carried out to ensure the continued safe use of the equipment.
Explosive Hazard
WARNING
MyLab
is not suitable for use in the presence of a flammable anaesthetic
mixture with air, oxygen or nitrous oxide. Do not use
MyLab
in the presence
of flammable anaesthetics. Explosion is a hazard under such conditions.
Содержание MyLab XPro75
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