Product Manual

USER SAFETY INFORMATION

• 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.

• 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.

• After operating the device using battery power, always reconnect the power cord. This ensures that

the batteries will be automatically recharged for the next time you use the device.

• The device is UL classified.

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,

CAN/CSA C22.2 No. 601.1, IEC 60601-1-1, CAN/CSA C22.2 No. 60601-

1-1-02, IEC60601-2-25 AND CAN/CSA C22.2 No. 601.2.25-94.