Cardioline HD+, User Manual

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HD+
2.
SAFETY INFORMATION
4

This device is designed to be used only with the electrodes specified in this manual. Strictly follow
the correct clinical procedures to prepare the skin before the application of the electrodes and
monitor the patient in order to avoid any irritation, inflammation or other skin reactions. The
electrodes are designed for short-term applications and must be promptly removed once the
examination is complete.

The ECG electrodes may cause skin irritation; check the skin for any irritations or inflammations.

To prevent any infections, use the disposable components (e.g. the electrodes) only once. To ensure
safety and use efficiency, do not use electrodes after their expiration date.

There is a risk of explosion. Do not use the device in the presence of flammable anaesthetics.

For the correct operation of the device and for the safety of the operators, patients and bystanders,
the device and the accessories must be exclusively connected as outlined in this manual.

The device is not designed for use with high-frequency (HF) surgical equipment, and does not
provide any protective means against hazards to the patient.

The quality of the signal produced by the electrocardiograph may be adversely affected by the use of
other medical equipment such as defibrillators and ultrasound machines.

There is no safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.

The operation may be adversely affected by the presence of strong magnetic fields such as those
produced by electro surgery equipment.

The battery-powered device transmits data that reflects the physiological condition of the patient to
a receiver. Should a malfunction occur, the transmission of the data and the display of the
information on the screen will be interrupted. It is advisable to have a spare device in the case of
emergency intervention.

Only use the recommended alkaline batteries. Using other types of batteries may cause danger of
fire or explosion.

The low battery warning is designed for the recommended batteries only. Using other types of
batteries may lead to a lack of indication resulting in device failure.

Do not clean the device or the patient cables by submersing them in liquid, autoclaving, or steam
cleaning. This may cause serious damage to equipment or reduce its lifespan. Using non-specific
detergents/disinfectants, failure to comply with the recommended procedures or contact with non-
specific materials may cause additional risks to operators, patients or bystanders or may damage the
device. Do not sterilise the device or the patient cable with ethylene oxide gas (EO). Refer to Section
4 for instructions on proper cleaning and disinfection.

HD+ may be used with the accessory HD+ Safety Shell, which allows the HD+ device to achieve
degree of protection IP 42. HD+ used without HD+ Safety Shell has a degree of protection IP40 and is
not therefore protected from ingress of liquids.

The use of HD+ Safety Shell worn or damaged might impair the degree of protection of HD+. If HD+
needs to be used in situations for which the IP42 degree of protection is essential to assure correct
operation, it is recommended to always keep an HD+ Safety Shell at hand for replacement.

Always check conditions of HD+ Safety Shell before use.