www.masimo.com
9
Masimo
Safety Information, Warnings and
Cautions
CAUTION
: SedLine is to be operated by, or under the supervision of, qualified personnel only.
Read the manual, accessories, directions for use, all precautionary information, and
specifications before use.
Refer to the Operator’s Manual for Root for additional safety
information, warnings and cautions.
Safety Information Warnings and Cautions
WARNING:
Do not start or operate the SedLine Module unless the setup was verified to be
correct. Improper set-up of the device may result in degraded performance and/or patient
injury.
WARNING:
Always use the SedLine Module and SedLine Sensor in conjunction with Root. Do
not use parts from other systems. Injury to personnel or equipment damage could occur.
WARNING:
All sensors and cables are designed for use with specific devices. Verify the
compatibility of the device, cable and sensor before use; otherwise degraded performance
and/or patient injury can result.
WARNING:
Do not use the SedLine Module if it appears or is suspected to be damaged.
Damage to the module enclosure can result in exposed electrical circuits that may cause
patient harm.
WARNING:
Do not adjust, repair, open, disassemble, or modify the SedLine Module. Damage
to the module may result in degraded performance and/or patient injury.
WARNING:
Do not use the SedLine Module in the presence of flammable anesthetics or other
flammable substance in combination with air or oxygen-enriched environments.
WARNING:
Do not use SedLine during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING:
To protect against Electrical Shock Hazard, 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 the SedLine 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 SedLine 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:
Use Patient State Index (PSi) information in conjunction with other indicators of
patient state in the delivery of anesthetics.
