Performance Warnings - Masimo Opioid Halo User Manual

Performance Warnings

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: Opioid Halo alarms may be less specific to OIRD when other medical conditions are
present (e.g., Obstructive Sleep Apnea). However, due to the emergency condition that opioid overdoses
can cause, the US CDC and SAMHSA recommend assuming any suspected opioid overdose be treated
as an actual opioid overdose.
WARNING: Obstructive sleep apnea (OSA) can increase the risk of false OIRD alarms by causing
oxygenation instability trends that can be mistaken as OIRD, which can disrupt sleep. If you have or think
you have OSA, seek advice from your Healthcare provider.
CAUTION: Do not use the Opioid Halo System as an apnea monitor. The Opioid Halo System is not
designed to detect apnea.
CAUTION: The Opioid Halo System is not a replacement for individuals that require post-surgical
monitoring directed by a physician.
CAUTION: The following factors can affect the effectiveness of Opioid Halo:
Sensor is applied incorrectly.
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Restricted blood flow to the sensor site.
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Sensor site has nail polish, acrylic nails, glitter, etc.
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A sensor site with moisture, birthmarks, skin discoloration, or foreign objects that block the
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sensor.
Placed near other devices that may interfere with its operation.
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Excessive movement of the sensor is present.
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Possible medical conditions (e.g., Obstructive Sleep Apnea).
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CAUTION: To ensure proper notification function, check the following occasionally:
Notification features is turned on your smart phone(i.e., sounds, vibrations, etc.)
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Smart phone battery is fully charged or plugged in.
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Halo indicator is active and green.
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Check your smart phone connection occasionally.
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CAUTION: Do not place the Opioid Halo System where someone can change the App settings
without you knowing.
CAUTION: Check that the Opioid Halo System alarm can be heard from other rooms in your home,
especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers, televisions, or
radios are operating.
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