SedLine Sedation Monitor
Safety Information, Warnings and Cautions
www.masimo.com
11
Masimo
•
Alfentanil
•
Desflurane
•
Fentanyl
•
Isoflurane
•
Nitrous Oxide
•
Propofol
•
Remifentanil
•
Sevoflurane
*All data is based on the retrospective analysis of clinical data in Masimo Corporation’s files.
Cleaning and Service Warnings and Cautions
WARNING
: Do not attempt to remanufacture, recondition or recycle the SedLine Module as
these processes may damage the electrical components, potentially leading to patient harm.
WARNING:
To avoid electric shock, always turn off SedLine and physically disconnect the AC
power and all patient connections before cleaning.
WARNING:
Service of the SedLine Module should be done by qualified personnel only.
CAUTION:
Only perform maintenance procedures specifically described in the manual.
Otherwise, return the SedLine Module for servicing.
CAUTION:
To avoid permanent damage to the SedLine Module, do not use undiluted bleach
(5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.
CAUTION:
Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
the SedLine Module. These substances affect the device’s materials and instrument failure
can result.
CAUTION:
Do not submerge the SedLine Module in any cleaning solution or attempt to
sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will
seriously damage the device.
CAUTION:
To prevent damage, do not soak or immerse the SedLine Module in any liquid
solution.
Compliance Information Warnings and Cautions
WARNING:
Any changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
CAUTION:
Disposal of Product: Comply with local laws in the disposal of the instrument
and/or its accessories.
NOTE:
Use SedLine in accordance with the Environmental Specifications section in the
Operator’s Manual for Root.
NOTE:
For FCC compliance information, refer to the Operator's Manual for Root.
NOTE:
For EMC compliance information, refer to the Operator’s Manual for Root.
