USER SAFETY INFORMATION
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• The WAM will automatically turn off when the electrocardiograph is powered down.
• The WAM will automatically turn off after being disconnected from the patient. This will happen regardless of
ELI 230 battery/AC power state.
• The display of absent waveform display while using the AM12 acquisition module could be due to an improper
auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.
• Square waves on the display and rhythm printout could be due to the WAM or the AM12 lead wires not being
connected to the patient.
• 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.
• If an electrode is not connected properly to the patient, or one or more of the patient cable lead wires are
damaged, the 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. Overload or saturation of amplifier inputs
will also result in lead fault indications.
• 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.
• This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored
according to the environmental conditions specified below:
Operating temperature: +10° to +40° C (+50° to +104° F)
Operating humidity: 10% to 95% RH, non-condensing
Storage temperature: -40° to +70° C (-40° to +158° F)
Storage humidity: 10% to 95% RH, non-condensing
Atmospheric pressure: 500 hPa to 1060 hPa
• WAM™ (wireless acquisition module) must be paired to electrocardiograph before operation.
• Device must be configured at the factory for use with the WAM.
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