Masimo LiDCO - Safety Information, Warnings and Cautions; Safety Warnings and Cautions

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Safety Information, Warnings and Cautions
CAUTION: Masimo LiDCO 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 the Root monitor for additional safety information, warnings and
cautions.
Note: For any serious incident that directly or indirectly led, might have led, or might lead to any of the
following, users and /or patients should notify the device manufacturer and their competent authority
where the serious incident took place.
a. The death of a patient, user or other person
b. The temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of
health
c. A serious public health threat
Note: Masimo LiDCO is for use in conjunction with a 3
rd
party patient monitor.
Note: Always use the correct cable for connecting the module to the 3
rd
party patient monitor.
Note: Additional information specific to the Masimo cables compatible with the module may be found in
the cable’s directions for use (DFU).
Safety Warnings and Cautions
WARNING: Do not use Masimo LiDCO 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 Masimo LiDCO. Damage to the module
may result in degraded performance and/or patient injury.
WARNING: Do not start or operate Masimo LiDCO unless the setup was verified to be correct. Improper
set-up of the device may result in degraded performance and/or patient injury.
WARNING: Do not place Masimo LiDCO or accessories in any position that might cause it to fall on the
patient.
WARNING: Only use authorized devices with Masimo LiDCO. Using unauthorized devices with the
module may result in damage to the device and/or patient injury.
WARNING: Do not use Masimo LiDCO in the presence of flammable anesthetics or other flammable
substance in combination with air, oxygen-enriched environments, or nitrous oxide to avoid risk of
explosion.
WARNING: Do not use Masimo LiDCO during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Masimo LiDCO may be used during defibrillation. However, to reduce the risk of electric
shock, the operator should not touch Masimo LiDCO during defibrillation.
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 module while monitoring patient.