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Warning; Regulatory Statements - opticis Stretch DVI M1-201SA-TR User Manual

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WARNING: Do not touch signal input, signal output of other connectors, and
the patient simultaneously.
WARNING: Do not connect any accessory except provided by Opticis. Any
damage caused other power adapters or accessories will not be taken any
responsibility by Opticis.
Warning for Medical usage
WARNING: External equipment intended for connection to signal input, signal
output or other connectors, shall comply with relevant IEC Standard(e.g.,
IEC60950 for IT equipment and IEC60601-1 series for medical electrical
equipment). In addition, all such combination-system-shall comply with the
standard IEC60601-1 and/or IEC60601-1-1 harmonized national standard or
the combination. If, in doubt, contact a qualified technician or your local
representative.
WARNING: (Detachable) Listed, Type SJT, min. No. 18 AWG, 3-conductor
terminating in molded-on Listed "Hospital Grade", parallel blade, grounding type
attachment plug rated minimum 15 A, 125 V.
Maximum 4.0 m long. Making tag provided indicating "Grounding reliability can
only be achieved when the equipment is connected to an equivalent receptacle
marked "Hospital Only" or "Hospital Grade"

1-9 Warning

Regulatory Statements

This equipment has been tested and found to comply with the limits for
medical devices in FCC/CE and
UL60601-1, 1st Edition, 2006
CAN/CSA-C22.2 No.601.1-M90, 2005
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.
Type of protection against electric shock: Class I equipment
Degree of protection against electric shock: Not classified - no applied
parts
Classification according to the degree of protection against ingress of
water as detailed in the current edition of IEC 529: IPX0, ordinary
equipment
This equipment is not suitable for use in the presence of flammable
anesthetics or oxygen
Mode of operation: continuous operation
1-10 Regulatory Statements

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