Mortara ELI 150 Rx, Руководство пользователя

Страница: 9 / 76

• Excessive patient movement could interfere with the operation of the device.
• Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
• 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.
• If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the
lead(s) where this 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 with air or with oxygen or nitrous oxide.
• 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. This light will turn off when the battery
is fully charged.
• 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
User Safety Information (Continued)
vii
Note(s)
5P35