Protection against electric shock:
The GRPro 2.1 System is considered to be Class I (protective earth) when connected to
the FSP Group, Inc. model FSP 030-RCAM power supply and Class II when connected to
the Mega MDM-030-A120-5396 power supply.
The MDM-030-A120-5396 power supply is intended for home use. The FSP 030-RCAM
power supply is not intended for home use.
Protection against harmful ingress of water:
This product provides ordinary protection against ingress of water. When used with the
MDM-030-A120-5396 power supply the device is classified to an IP22 rating, which is a
protection against dripping water.
Pollution degree classification:
This product is classified as Pollution degree 2.
Degree of safety in the presence of flammable anesthetics or oxygen:
Not suitable for use in an oxygen enriched environment or in the presence of flammable
anesthetics.
Electromagnetic interference:
This equipment has been tested and found to comply with the limits for medical devices
in IEC 60601-1-2:2007 and IEC 60601-1-2:2014. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the 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 this equipment does cause harmful interference to other devices, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
Reorient or relocate the receiving device.
•
Increase the separation between the equipment. Connect the equipment into an outlet
•
on a circuit different from that to which the other device(s) are connected.
Consult the manufacturer or field service technician for help.
•
The device is intended for use in orthopedic centers, therapy clinics, athletic training
facilities, hospitals, nursing facilities, medical centers, as well as in patient homes. The
device should not be used in an environment where the intensity of electromagnetic
disturbance is high.
In the event the device experiences a loss of performance or degradation due to
electromagnetic disturbance, the device is expected to continue to operate safely.
The device should not be used less than 30 cm (12 inches) away from any portable and
mobile RF communications equipment.
EN- 18
U L C L A S S I F I C A T I O N
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