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User's Manual

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Page 83
Standards and compliance
FCC warning
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential 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 radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, 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:
l Reorient or relocate the receiving antenna.
l Increase the separation between the equipment and receiver.
l Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
l Consult the dealer or an experienced radio/TV technician for help.
FCC Caution: Any changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate this equipment.
This device and its antenna(s) must not be co-located or operating in conjunction with any
other antenna or transmitter.
Safety
General Standard EN 60601-1: 1990+A1: 1993+A2: 1995
(Medical Electrical Equipment – Part 1: General
Requirement for Safety)
EMC Standard EN 60601-1-2: 2007
(Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance Collateral standard:
Electromagnetic compatibility – Requirements and tests)
Type of protection
against electric shock
Class I Equipment (During AC power operation)
Internally powered Equipment (During battery operation)
Degree of protection
against electric shock
ECG/RESP: Type CF Applied Part
SpO2, NIBP: Type BF Applied Part'
Operation Mode Continuous Operating Equipment
The degree of protection
against ingress of water
IP 21
Protection against Ignition
of Flammable Gas
Not Provided
Performance
This section states the performance of this equipment.
Sound Pressure