Mortara ELI 280, User Manual, Page: 15 / 89

USER SAFETY INFORMATION
9

The display of a thick baseline while using the AM12 acquisition module (square waves on rhythm printout)
could be due to an improper auto-calibration. Reconnect the AM12 or power cycle the electrocardiograph.

A square wave on the display and rhythm printout could be due to the WAM, the AM12, or lead wires not
being connected to the patient.

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

The device will automatically turn off (blank screen) if the batteries have been severely discharged and the AC
mains is disconnected from the device.

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. A light next to the on/off switch
will illuminate indicating that the device is charging.

WAM must be paired to electrocardiograph before operation.

The device must be configured at the factory for use with the WAM.

The device is UL classified:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1,
AND IEC60601-2-25