Cardioline HD+, User Manual

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HD+
2.
SAFETY INFORMATION
3
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® if you want to connect any devices not listed in this manual.
Caution: US Federal law restricts this device to sale by or on the order of a Physician.
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.

The device captures 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 device is intended for use by properly trained operators. Have the operator carefully read and
understand the contents of the operator manual and the other annexed documents before using the
device.

The safety of the patient and the operator is guaranteed if the peripheral units and the accessories
that can come into direct contact with the patient comply with the UL 60601-1, IEC 60601-1 and IEC
60601-2-25 standards. Only use spare parts and accessories supplied with the device and available
from Cardioline SpA.

The patient cables to be used with the device are defibrillation-proof. Check the patient cables for
ruptures or cracks before use.

Conductive parts of the patient cable, electrodes and associated connections of type CF applied
parts, including the neutral conductor of the patient cable and electrode, should not come into
contact with other conductive parts, including earth ground.

To prevent death or any serious personal injuries during defibrillation, avoid contact with the device
or patient cables. It is furthermore necessary to properly position the defibrillation pads with respect
to the electrodes in order to minimize patient skin burns.

Protection from defibrillation is only guaranteed if an original patient cable is used. Any
modifications to the device may affect the protection from defibrillation.