Product Manual

USER SAFETY INFORMATION
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 This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be
employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
other adverse reactions. Electrodes are intended for short-term use and should be removed from the patient
promptly following testing.
 To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
 To ensure the safety of both the patient and the device, 1.5 meters (5’) of open area should surround the patient.
 A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
 Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated
from its internal electrical power source.
 All signal input and output (I/O) connectors are intended for connection of only those devices complying with
IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. Connecting additional
devices to the device may increase chassis and/or patient leakage currents. To maintain operator and patient
safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be
measured to confirm no electric shock hazard exists.
 To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended when
connecting the device to a network.
 To maintain operator and patient safety, equipment connected to the same network as the device must meet the
requirements of IEC 60950 or IEC 60601-1.
 To prevent electric shock due to unequal ground potentials that may exist between points of a distributed
network system or fault conditions in external network connected equipment, network cable shielding (where
used) must be connected to protective earth ground appropriate to the area where the device is used.
 The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
 The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
 For proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual. Do not connect a telephone line cable to the LAN connector.
 Some Mortara electrocardiographs can be equipped with a GPRS (cellular modem) or wireless LAN (WLAN)
module for transmitting ECG records. Device labeling and the presence of an antenna port will indicate if your
device is equipped with such a module. If so equipped, the following notices apply:
 The GPRS module operates in allocated frequency bands depending on the model. Identification of
the installed GPRS module can be found on a label on the bottom of the device.
 MultiTech Systems, Inc. Model MTSMC-G-F4 (Quad Band): 850/900/1800/1900 MHz, user
selectable
 The WLAN identification can be found on a label on the bottom of the device.
 Quatech, Inc. Model WLNG-AN-DP101: 2400 MHz
(model subject to change without notice)