Product Manual

USER SAFETY INFORMATION
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Note(s)
 Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
 Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
 The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and tries
to identify the most likely switch; however, it is advisable to check the other electrode positions in the same
group (limb or chest).
 There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
 A square wave presentation on the display while using the WAM may be due to the WAM being turned off,
having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the
LED indicator on the WAM to ensure the unit is turned on, has proper battery level, is paired correctly, and is
within recommended proximity of the electrocardiograph, or power cycle the WAM to re-calibrate.
 A square wave presentation on the display while using the AM12 may be due to improper auto-calibration.
Power cycle the AM12 or the electrocardiograph.
 If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,
display will indicate a lead fault for the lead(s) where the condition is present and if the signal is being printed,
the respective lead(s) will print out as a square wave.
 As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
 Class I equipment or internally powered.
 Type CF defibrillation-proof applied parts.
 Ordinary equipment.
 Equipment not suitable for use in the presence of a flammable anesthetic mixture.
 Continuous operation.
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this device is
declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with
mains. The ground terminal on the mains inlet is the only protective earth point in the device. Exposed
metal accessible during normal operation is double insulated from mains. Internal connections to earth
ground are functional earth.