Cautions And Warnings; Standards/Approvals - laerdal Resusci Anne Gebrauchsanweisung

Cautions and warnings

- There are electronic components mounted inside the simulator's
airway management head. The following techniques should not be
performed on this simulator due to the inability to properly sani-
tize the airway if they are performed:
1. Mouth-to-mouth/Mouth-to-mask ventilation
2. Insertion of simulated vomit for suctioning
- Lubricate the oral and nasal airways liberally with the lubricant
provided prior to inserting any instrument or tube into the airway.
Additionally, instruments and tubes should also be lubricated prior
to use.
- Do not allow the manikin's skin to come in direct contact with ink
or photocopied paper, as this can permanently stain the skin.
Avoid using colored plastic gloves when handling the manikin, as
they may also cause discoloration.
- Care should be taken when palpating the pulses to not use
excessive force as this will result in no pulse being felt. Only two
individual pulses can be felt at the same time.
- When the Resusci Anne Simulator is in the "Off" status the
airway will remain open. If the simulator is turned off while the
closure valve is in the closed position it will open automatically
when the simulator is turned off.
- To avoid damaging the spontaneous breathing bladder, do not
perform chest compressions while the spontaneous breathing
function is activated.
- Maximum pressure in the spontaneous breathing
unit air tank is 10 bar (145 psi). Do not try to inflate over this
maximum pressure level as damage may occur.
- If a training session involves the administration of fluids and/or
drugs into the IV arm, empty the arm immediately following the
training session.
Defibrillation
- Only apply the defibrillator to a defibrillation chest skin which
is properly mounted on the manikin's chest.
- Do not provide more than 2 x 360J defibrillator discharges
per minute as an average over a period of time to prevent
overheating.
- The manikin chest must be kept dry. Special attention should
be taken when using IV Arm.
- Do not apply conductive gel or conductive defibrillation pads
intended for patient use to prevent chest skin pitting.
- Do not use cables or connectors with visible damage.
- Observe all normal safety precautions for use of defibrillators.
- Defibrillation must be performed over the two defibrillation
connectors only.
- Electromagnetic radiation from other radio transmitters or
other electronic equipment may cause noise in the head
speaker. To eliminate this noise move manikin away from
the radiation source or turn the head speaker volume to zero.

Standards/Approvals

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
interference that may cause undesired operation.
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 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:
- Reorient or relocate the receiving antenna.
- Consult the dealer or an experienced radio/TV technician
for help.
- 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 declares that when carrying the CE-mark,
the VitalSim product is in compliance with the essential require-
ments and other relevant provisions of Directive 1999/5/EC.
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