Notice To Responsible Service Personnel; Performance Disclosures - Cardiac Science Atria 6100 Operating Instructions Manual

Notice to Responsible Service Personnel

Performance Disclosures

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70-00082-01 A
The contents of this document are not binding. If you find a significant
difference between this service information and your Atria, please contact
Cardiac Science Technical Support. We reserve the right to improve or
modify products without amending this document or advising the user.
We recommend consulting authorized personnel for all service and repairs,
and using only approved replacement parts. Cardiac Science Corp. will not
otherwise assume responsibility for material quality, workmanship, or any
consequences thereof if approved replacement parts are not used.
This product has been carefully designed and manufactured to provide a
high degree of safety and dependability. However, we can not guarantee
against the failure or deterioration of components due to aging and normal
use.
Explosion hazard. Do not use in the presence of flammable anesthetics,
other gasses that support combustion, or in a high-oxygen atmosphere.
Patient injury or death. Do not use the Atria for unattended or continuous
patient monitoring. The Atria has no audible or visible alarms and change
to patient condition may not be immediately known.
The Atria is only intended for short-term ECG waveform acquisition.
Electromagnetic interference. Position the Atria away from other electrical
or electronic equipment, if possible. The presence of strong EMI fields, or
generated by RF noise on the line power, or by electronic, surgical, or
diathermy instruments in close proximity to the Atria may cause trace
noise or input overload conditions.
If used with, or around, other electrical or electronic equipment, always
carefully monitor initial readings to verify normal operation.
The Atria is compliant with IEC 60601-1-2 EMC immunity requirements.
Refer to "EMC Declaration Tables" on pg. 11-10.
Misdiagnosis. U.S. Federal law restricts this device to sale by or on the
order of a physician. The Atria must only be used by qualified operators
and any results interpreted by a qualified diagnostician.
Notice to Responsible Service Personnel
WARNING
WARNING
WARNING
WARNING
Atria Electrocardiograph Operating Instructions 11-7