Safety Information, Warnings And Cautions; Safety Warnings And Cautions; Performance Warnings And Cautions - Masimo O3 Operator's Manual

Safety Information, Warnings and
Cautions
CAUTION: O3™ Regional Oximeter is to be operated by, or under the supervision of, qualified
personnel only. The manual, accessories, directions for use, all precautionary information, and
specifications should be read before use.

Safety Warnings and Cautions

WARNING: Do not use the O3 Module if it appears or is suspected to be damaged.
WARNING: Always use O3 Module in conjunction with Root. Do not use parts from other
systems. Injury to personnel or equipment damage could occur.
WARNING: Do not adjust, repair, open, disassemble, or modify the O3 Module. Injury to
personnel or equipment damage could occur.
WARNING: Do not start or operate the O3 Module unless the setup was verified to be correct.
WARNING: Do not use O3 Module during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Explosion hazard: Do not use the O3 Module in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
WARNING: To protect against injury, follow the directions below:
•
Avoid placing the device on surfaces with visible liquid spills.
•
Do not soak or immerse the device in liquids.
•
Use cleaning solutions only as instructed in this Operator's Manual.
•
Do not attempt to clean O3 Module while monitoring patient.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.

Performance Warnings and Cautions

WARNING: The O3 Module may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
WARNING: The O3 Module may be used during defibrillation; however, the display may
require up to 15 seconds to return to normal operation.
WARNING: The O3 Module is intended only as an adjunct device in patient assessment. It
should not be used as the sole basis for diagnosis or therapy decisions. It must be used in
conjunction with clinical signs and symptoms.
WARNING: If the desired tissues cannot be palpated or visualized, it is recommended to use a
secondary method of confirmation, such as ultrasound or X-ray.
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