Mortara ELI 10 Rx, User Manual

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USER SAFETY INFORMATION
viii

To ensure compliance with current regulations limiting both maximum RF output power and human exposure
to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's
antenna and the head and body of the user and any nearby persons at all times. RF exposure to wrists and
hands within the 20 cm distance while operating the device in the normal hand-held position is not subject to
the same distance restriction and is believed to be safe. To help prevent degradation of RF signal and to avoid
excess RF energy absorption, do not touch the antenna during data transmission.

The GSM/GPRS and WLAN modules comply with applicable RF safety standards including standards and
recommendations for the protection of public exposure to RF electromagnetic energy that have been
established by governmental bodies and other qualified organizations, such as the following:

Federal Communications Commission (FCC)

Directives of the European Community

Directorate General V in Matters of Radio Frequency Electromagnetic Energy
Caution(s)

To prevent possible damage to the keyboard, do not use sharp or hard objects to depress keys, only use
fingertips.

Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning
as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild
detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to
follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to
users, patients and bystanders, or damage to the device.

No user-serviceable parts inside. Screw removal by qualified service personnel only except for installation of
SIM card. Damaged or suspected inoperative equipment must be immediately removed from use and must be
checked/repaired by qualified service personnel prior to continued use.

The rechargeable internal battery is a sealed lithium ion type and it is totally maintenance free. If the battery
appears to become defective, refer to Mortara Instrument Service Department.

Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored after forming them into a loose loop.
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.

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 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.