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About warnings and cautions
Warning and caution statements can appear on the ECG module, on the packaging, on
the shipping container, or in this document.
The ECG/Impedance Respiration module is safe for patients and clinicians when used in
accordance with the instructions and the warning and caution statements presented in
this manual.
Before using the module, you must familiarize yourself with all warnings and cautions
and with the sections of this directions for use that pertain to your use of the module. In
addition, you must review the warnings and cautions presented in the Welch Allyn
Connex® Devices directions for use that pertain to using a connected ECG module.
•
Failure to understand and observe any warning statement in this manual could lead
to patient injury, illness, or death.
•
Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
General warnings and cautions
WARNING Many environmental variables, including patient physiology and
clinical application, can affect the accuracy and performance of the Connex
device and ECG module. Therefore, you must verify all vital signs
information before treating the patient. If there is any question about the
accuracy of a measurement, verify the measurement using another
clinically accepted method.
WARNING To comply with Federal Communications Commission (FCC)
RF exposure requirements and to avoid exposure to radio-frequency (RF)
radiation, always use the monitor in accordance with the operating
conditions and instructions provided in this manual.
WARNING Always check the patient mode (adult, pediatric, or neonate)
when monitoring a new patient. The patient mode determines default
alarm limits and internal algorithm settings. Alarm limits are patient-
specific. Make sure the monitor has settings that are appropriate before
monitoring the patient. For alarms to function properly, you must set or
verify alarm limits appropriate for each patient. Each time the Connex
device is powered on, you must check that the alarm settings are
appropriate for your patient before you start monitoring.
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