Cardioline ECG100+ - SAFETY INFORMATION; General Safety Warnings and Precautions

ECG100+ - ECG200+ - ECG100S - ECG200S
2. SAFETY INFORMATION
2. SAFETY INFORMATION
Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if:
1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its
Authorised Service Centre;
2. The device is used in compliance with the instructions provided in the use manual.
Always contact Cardioline SpA should you wish to connect any devices not mentioned in this manual.
Warnings
 This manual provides important information on proper use and safety of the device. Failure to
comply with the described operating procedure, improper use of the device, ignoring the
specifications and recommendations supplied, may cause severe physical injuries to the operators,
patients and bystanders, or may damage the device.
 No modification of this equipment is allowed.
 The device captures and presents the data that reflects the physiological condition of the patient;
this information can be examined by specialist medical staff and will be useful in providing an
accurate diagnosis. In any event, the data cannot be used as the only means to make an accurate
diagnosis of the patient.
 The operators for whom this device is intended must have the required competence regarding
medical procedures and the treatment of patients. They must also be sufficiently trained in using the
device. Have the operator carefully read and understand the contents of the operator manual and
the other annexed documents before using the device for clinical applications. Inadequate
knowledge or training could be at a greater risk for the physical safety of operators, patients and
bystanders, or could damage the device. In case the operators are not trained in using the device,
we recommend to contact Cardioline or its Authorised Distributors to plan adequate training
courses.
 The device and its power supply are classified as ME Equipment, since the power supply is
considered an integral part of the device.
 US Federal law restricts this device to sale by or on the order of a Physician.
 To avoid the risk of electric shock, this equipment must only be connected to a supply main with
protective earth.
 If in doubt regarding the integrity of the external earth conductor, use the device with its inner
battery.
 The positioning of the device must be such as to don't make difficult the operation of disconnection
from main supply when an external power supply is used. The plug of the main supply is the main
switch used to disconnect the device from the main supply. Please, be sure to keep it near the
device.