7
5
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-S, 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
sulphides, 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.
This device is not to be used during a flight.
Light radiation
The light emitted from this instrument is potentially hazardous. The longer the duration of exposure,
the greater the risk of ocular damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 30 minutes.
