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2 Safety, Warnings and Precautions
This chapter defines safety Warnings and Precautions applicable to the UltraPro S100 system. Read all Contraindications,
Warnings and Cautions prior to use of the UltraPro system.
Two labels identify potentially dangerous or destructive conditions and procedures:
Warning A
WARNING
indicates that there is a risk of death or serious injury to the user or patient.
Caution A
CAUTION
indicates that there is a risk of injury to the user or patient or risk of damage to the device.
Any serious incident that has occurred in relation to the Natus UltraPro S100 system be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Contraindications
There are no known contraindications under normal clinical use.
Operating Environment: Inflammable Vapors or Gases
The equipment is not designed to be used in locations with inflammable vapors or gases that may cause
explosions. The equipment must not be used in atmospheres with a high concentration of oxygen or in buildings
where inflammable substances or anesthetic agents are present. The atmosphere is considered as oxygen-
saturated when the oxygen or nitrous oxide (N2O) concentration contained in the environment is over 24%.
Potential Electrical Shock (Line Voltage)
System components immersed or in contact with fluids may cause electrical shock. Source currents to the patient
due to use of a repaired components that have not been leakage tested may cause electrical shock.
Loss of AC neutral due to damage to the neutral conductor may cause electrical shock.
Loss of AC ground connection may cause electrical shock.
Over voltage conditions due to a fault in other equipment may cause electrical shock.
Over voltage conditions due to the input voltage exceeding the operating range may cause electrical shock.
Incorrect installation of cables on/to the system may cause electrical shock.
