Cautions And Warnings; General Simulator Handling - Laerdal SimBaby Mode D'emploi

Disclaimer
Use of the Patient Simulator system to train personnel should be
undertaken under supervision of suitably trained medical personnel
with an understanding of educational principles as well as recognized
medical protocols.
As with all Patient Simulators or other such training devices there
may be approximations, variations and inaccuracies in anatomical
features and the physiological modeling. This being the case, Laerdal
Medical does not guarantee that all features are completely accurate.

Cautions and Warnings

A Caution identifies conditions, hazards, or unsafe practices that can
result in minor personal injury or damage to the Simulator.
A Warning identifies conditions, hazards, or unsafe practices that can
result in serious personal injury or death.

General Simulator Handling

Warnings
– Do not ventilate the Patient Simulator with oxygen enriched air or
flammable gases.
– Only use fluids as directed in the Directions for Use, otherwise this
may damage the Patient Simulator and its components.
– Do not introduce humidified air into the system during ventilation.
– Never perform mouth-to-mouth or mouth-to-nose rescue breathing
on the Patient Simulator. The simulator's airways are not designed for
cleaning or disinfection.
– Do not use the Patient Simulator if the internal tubing and cabling is
disconnected.
– Never use the Patient Simulator in temperatures exceeding 40 °C
(104 °F), as this may cause overheating and shut down.
– Never use the Patient Simulator in temperatures below 10 ºC (50 ºF).
– The Patient Simulator should never be stored in temperatures below
-15 °C (5 °F) or over 50 °C (122 °F).
– Using a defibrillator in temperatures over 35 °C (95 °F) may cause
overheating and shut down.
– Avoid pinch hazards - Do not remove protective bushings from the
Patient Simulator's joints or use it without the external skins.
– Avoid all sharp edges on the Patient Simulator to prevent personal injury.
Transportation and Storage
Ensure that the Patient Simulator is properly secured during trans-
portation to prevent personal injury or damage to the product.
CAUTIONS AND WARNINGS
Defibrillation Hazards
A conventional defibrillator may be used on SimBaby. During live de-
fibrillation, the defibrillator and Patient Simulator may present a shock
hazard. All standard safety precautions must be taken when using a
defibrillator on the Patient Simulator. For more information, consult
your defibrillator's User Guide.
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General Use
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5
Warnings
The ECG connectors are designed exclusively for ECG monitoring
and must not be used for defibrillation. Defibrillation on the ECG
connectors will damage the internal electronics of the Patient
Simulator and may cause personal injury.
Defibrillation must be performed on the defibrillator connectors only.
The Patient Simulator must not come into contact with electrically
conductive surfaces or objects during defibrillation.
Do not defibrillate the Patient Simulator in a flammable or oxygen
enriched atmosphere.
The Patient Simulator torso must always be kept dry. Allow the
Patient Simulator to acclimate before defibrillating. Sudden changes in
temperature (moving the Patient Simulator from a cold environment to a
warm environment and vice versa) may result in condensation collecting
on the base board and pose a shock hazard.
If defibrillation is performed over one or more of the ECG connectors,
high voltages may be present on the remaining connectors during
the shock. Defibrillation attempts via the ECG connectors will also
damage the internal electronics requiring that they have to be
replaced.
To prevent overheating, do not provide more than three (3)
defibrillator discharges (max 360J) in a sequence. Do not exceed
an average of two (2) defibrillator discharges per minute during the
training session.
The simulator must not be in contact with electrically conducting
surfaces or objects during defibrillation. A flame-supporting
atmosphere, for example with a high content of oxygen, should be
avoided during defibrillation.
To prevent chest skin electrode pitting, do not apply conductive gel or
conductive defibrillation pads intended for patient use.
Do not use cables or connectors which have visible damage.
Cautions
Do not introduce any fluids (except airway lubricant in small
amounts to lubricate the airway adjuncts) into the esophagus or
trachea of the simulator.
After each session involving airway lubricant the esophagus filter
must be replaced. See "Maintenance" for more information.
If a training session involves the administration of fluids and/or drugs
into the IV Arm and IO/IV Legs, empty the arm and legs immediately
following the training session.
Electromagnetic radiation from other radio transmitters or other
electronic equipment may cause noise in the head speaker. To
eliminate this noise move simulator away from the radiation source
or turn the head speaker volume to zero.