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6 Precautions
Electromagnetic compatibility
This device has been tested and found to comply to the limits for medical devices
contained in IEC60601-1-2 and in Medical Device Directive 93/42/EEC. These limits are
intended to provide reasonable protection against harmful interference in a typical medical
installation. This instrument generates, uses and can radiate radio frequency energies and,
if not installed and used in accordance with these instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that interference
will not occur in a particular installation. If the system does cause harmful interference to
other devices, which can be determined by turning the system off and on, try to eliminate
the interference by adopting one or more of the following measures:
• reorient and/or relocate the receiving device;
• increase the distance between the devices;
• In case of charging of the device, connect the system to an outlet on a different circuit
than that to which the other devices are connected;
• consult the manufacturer or field service technician for help.
This equipment has been verified to comply with the limits for a class B computing
device, pursuant to FCC Rules. In order to maintain compliance with FCC regulations,
shielded cables must be used with this equipment. Operation with non-approved equipment
or unshielded cables is likely to result in interference to radio and TV reception. The user is
cautioned that changes and modifications made to the equipment without the approval of
manufacturer could void the user’s authority to operate this equipment.
Portable and mobile RF communications equipment, such as cell phones, can affect
medical electrical equipment: any RF communications equipment shall be used no
closer than 30 cm (12 inches) to any part of the 2WIN, including its cables.
The area where the device is to be installed has to comply to the IEC/ISO standards
related to the medical use of an area.
The device must NOT be used in oxygen rich environments or in presence of
flammable products.
The device must not be installed in a room exposed to chemical-physical aggressive
agents (such as as sulfides, salt, dust, etc.), nor exposed to direct sunlight or lack of
ventilation, high humidity, sudden surges or drops in temperature. The safety and efficiency
of the instrument are not guaranteed under these conditions.
This device is designed to be used indoor. Do not expose the device to water: this
could lead to fire or electric shock.
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