Safety Information; Safe Use Information - Masimo Opioid Halo User Manual

Safety Information

Before using the Opioid Halo System, read the following Safety Information carefully.
WARNING: It is strongly recommended supervision be provided with naloxone. Please make sure that
anyone providing supervision is aware of signs of opioid overdose and understands how to help.
WARNING: Do not wait for an alarm. If you suspect someone is having an opioid overdose, call 911
and administer naloxone, if needed!
WARNING: Do not take more than the prescribed amount of opioids. Taking more than prescribed
can result in an overdose that can stop breathing and lead to death.
For Healthcare Providers
WARNING: Do not prescribe opioids above the standard of care based upon the use of the Opioid
Halo. There is no assurance that patients will use this device.
WARNING: Do not make opioid prescription decisions solely on the availability of the Opioid Halo! It is
important that you make sure your patient has someone who can respond to any alarms, including the
administration of naloxone.

Safe Use Information

WARNING: Do not use in areas where flammable gases such as anesthetics, oxygen, oxygen-
enriched environments, or nitrous oxide are present to prevent risk of fire.
WARNING: Do not wait for an alarm. If you suspect someone is having an opioid overdose, call 911
and administer naloxone, if needed!
CAUTION: The complete Opioid Halo System should be used. The system consists of the Home
Medical Hub, the Masimo Halo App Installed on a smart phone, Masimo Sensor, and Masimo Chip. To
learn more, see Home Medical Hub Setup on page 22.
CAUTION: Route cables to avoid possible strangulation or entanglement.
CAUTION: Place the Home Medical Hub where it will not fall on anyone, and the alarm sounds will not
be muffled.
CAUTION: Check the Opioid Halo indicator is green, Pulse Rate waveform is active, and Pulse Rate
is displayed on the Live Data screen to ensure monitoring has started. See Step 3: Live Data on page
31.
CAUTION: For safe use, avoid the following:
Do not place the Home Medical Hub on a wet surface.
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