Introduction; Introduction And Intended Use; Important Information - laerdal SimNewB Directions For Use Manual

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SimNewB.qxp:SimNewB DFU EN
S
I
NTRODUCTION
SimNewB™ Neonatal Simulator
Simulation made simple...for newborns
SimNewB™ is an interactive simulator designed by Laerdal
with the American Academy of Pediatrics to meet the training
requirements of the Neonatal Resuscitation Course (NRP)
course. With realistic newborn traits and lifelike clinical feed-
back, SimNewB is ideal for training for the specific needs of
neonates.
Scalable Training Solution
SimNewB is available in standard and advanced versions enab-
ling instructors to vary simulations from the delivery room to
the NICU. The basic version utilizes a handheld Remote
Control with preset patient states while the advanced version
operates the simulator via SimNewB PC Software.
SimNewB System Description
The SimNewB Control Unit performs simulations and con-
nects to the manikin. The Control Unit can be battery opera-
ted, allowing simulations to be performed any where. The ope-
rator controls simulations with a user-friendly Remote Control,
communicating with the Control Unit through radio frequency
(RF) communication. RF communication allows the operator
to move freely around the scene, up to a distance of 10 me-
ters (30 ft.) from the Control Unit.
The SimNewB Advanced Neonatal Simulator system allows
operation of the simulator from either the PC User Interface
or the standard Remote Control.
Note:
- When using the PC User Interface, the Remote Control
should not be used.
- When using the Remote Control, the PC User Interface
should not be connected to the Control Unit.
Included in the system is a PC-based Scenario Builder pro-
gram, allowing the user to preprogram simple, linear scenarios.
These custom built scenarios may then be downloaded and
run by SimNewB system. Scenarios can control all output
parameters of the SimNewB system and make parameters
change based on certain events. The SimNewB system will
also generate logs that can be uploaded to a PC for review
and printing.

Important Information

This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this
device must accept any interference received, including interfe-
rence that may cause undesired operation.
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Introduction and Intended Use

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NOTE: 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 reaso-
nable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate ra-
dio frequency energy and, if not installed and used in accor-
dance 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 televi-
sion reception, which can be determined by turning the equip-
ment 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 antenna.
-
Increase the separation between the equipment
and receiver.
-
Connect the equipment into an outlet on
a circuit different from that to which the receiver
is connected.
-
Consult the dealer or an experienced
radio/TV technician for help.
Caution: Changes or modifications not expressly approved by
Laerdal could void the user's authority to operate this equipment.
Hereby, Laerdal Medical AS declares that when carrying the
CE-mark, the SimNewB system product is in compliance with
the essential requirements and other relevant
provisions of Directive 1999/5/EC.
Use with Laerdal Manikins
SimNewB system will only work with SimNewB system ele-
ments (Manikin, Control Unit, Remote Control). Do not at-
tempt to use similar looking Laerdal VitalSim system elements
with SimNewB elements.
RF Communication
Communication between the Remote Control and Control
Unit is based on low power radio frequency communication.
The equipment meets the standards and requirements of FCC
and EC. If SimNewB system is used in an environment where
RF communication is not desirable, or where interference
from other sources makes SimNewB system inoperable, it is
recommended to use cable connection between the Remote
Control and the Control Unit. Using the direct cable connecti-
on disables the RF circuits in both units. The cable is included in
the SimNewB system package.
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