Masimo Opioid Halo User manual

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There may be information provided in this manual that is not relevant for your system. Do not operate the
Opioid Halo System without completely reading and understanding these instructions. If you encounter
any serious incident with product, please notify the competent authority in your country and the
manufacturer.
Wireless Radio:
Contains: FCC ID: 2AC7Z-ESP32SOLO1; FCC ID: VKF-CONNHUB Contains IC: 21098-ESP32SOLO1;
IC: 7362A-CONNHUB
Manufacturer:
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
Patents: www.masimo.com/patents.htm
Masimo®, ®, and Masimo SafetyNet® are federally registered trademarks of Masimo Corporation.
Masimo Halo™ and Opioid Halo™ are trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2023 Masimo Corporation

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Contents
About This Manual ......................................................................................................................................................................5
Getting Started Guides........................................................................................................................................................5
In-App Videos........................................................................................................................................................................5
Glossary.................................................................................................................................................................................5
Preventing Opioid Overdoses (SAMHSA)............................................................................................................................7
Product Description .....................................................................................................................................................................9
Product Description..............................................................................................................................................................9
Who the Device is intended for (Indications for Use)....................................................................................................9
Who the Device Should not be used on (Contraindications)......................................................................................9
Safety Information..................................................................................................................................................................... 10
Safe Use Information........................................................................................................................................................ 10
Performance Warnings.................................................................................................................................................... 12
For Supervisors or Caregivers........................................................................................................................................ 13
Cleaning and Service ....................................................................................................................................................... 14
Radio Compliance ............................................................................................................................................................ 14
Risks and Benefits.................................................................................................................................................................... 15
Opioid Induced Respiratory Depression (OIRD)........................................................................................................ 15
Risks of Opioid Halo ......................................................................................................................................................... 16
Benefits of Opioid Halo..................................................................................................................................................... 16
Description.................................................................................................................................................................................. 17
Opioid Halo System.......................................................................................................................................................... 17
Features.............................................................................................................................................................................. 18
BasicSetup and Use............................................................................................................................................................... 21
Getting Started................................................................................................................................................................... 21

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Step 1: Smart Phone Setup ............................................................................................................................................21
Step 2: Opioid Halo System Setup................................................................................................................................22
Step 3:Live Data................................................................................................................................................................32
Troubleshooting.........................................................................................................................................................................39
Opioid Halo Messages.....................................................................................................................................................39
Troubleshooting Opioid Halo...........................................................................................................................................42
Troubleshooting Measurements....................................................................................................................................46
Appendix .....................................................................................................................................................................................47
Specifications......................................................................................................................................................................47
Service and Maintenance................................................................................................................................................63
Concepts of Alarm Response Delay.............................................................................................................................65
Index.............................................................................................................................................................................................67

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About This Manual
This Manual provides an overview of the Opioid Halo System and how to set up and use the Opioid Halo
System. You must read and understand the warnings and precautions to help ensure safe and effective
use of the Opioid Halo System. Please make sure to read the entire manual and notes.
A warning is given when there is reasonable evidence of an association of a serious hazard with use of
this device that may result in a serious injury, adverse effect, or death to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when special care is to be exercised by the patient or user to avoid injury to the patient,
damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional information applies.
Note: This is an example of a note.
Getting Started Guides
Use the quick reference guide included for basic setup and starting your first monitoring session.
In-App Videos
Watch the videos in your app to find out more about:
•Setting up your Opioid Halo System.
•Masimo Sensor placement.
•Connecting your Opioid Halo System to WiFi.
Glossary
Apnea: A sleep disorder in which breathing starts and stops.
Naloxone: A medication approved by the Food and Drug Administration (FDA) designed to rapidly
reverse opioid overdose and OIRD.
Obstructive Sleep Apnea (OSA): Obstructive sleep apnea occurs when the muscles that support the
soft tissues in your throat, such as your tongue and soft palate, temporarily relax. When these muscles
relax, your airway is narrowed or closed, and breathing is momentarily cut off.

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Opioid Induced Respiratory Depression (OIRD): A side effect of opioids that causes breathing to be
slowed or stopped.
Oxygenated Blood: Arterial blood where oxygen is bound to hemoglobin.
Perfusion: The bodily process of delivering blood to the capillary beds.
Physiological: The functions of biological systems and organs.
Pulse Oximeter: A medical device that uses a sensor to indirectly measure oxygen saturation of blood
and pulse rate.

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Preventing Opioid Overdoses (SAMHSA)
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.
Opioid overdoses are deadly.
To help prevent opioid overdoses it is important to avoid using opioids without supervision. The Opioid
Halo System is designed as a tool to help increase awareness and recognition to prevent opioid
overdoses.
The most important part of this solution is that people are aware of signs of opioid overdose and
understand how to help. Let someone know about this product and share how they can recognize and
help if there is an opioid overdose.
SAMHSA1recommends 5 steps to help prevent opioid overdoses.
STEP 1 – Evaluate for Signs of Opioid Overdose
•Are they unconscious or unable to wake up?
•Are they having difficulty breathing?
•Are their fingernails or lips turning blue?
If you think they are having overdose, try to wake them up:
•Call their name.
•Rub your knuckles on the bone in the middle of their chest.
STEP 2 – Call 911 for Help
•If they are not responding or cannot stay responsive, call 911 to get help. Opioid overdose is
an emergency.
STEP 3 – Administer Naloxone
•If you still suspect they are overdosing, administer naloxone.
•Administer a 2nd dose of naloxone if not responding 2 to 3 minutes after the first dose.
STEP 4 – Support the Person’s Breathing
•Keep their airway clear.
STEP 5 – Monitor the Person’s Response
•Naloxone can cause opioid withdrawal symptoms to return or only last of short duration.
Watch them to make sure they do not start to overdose again.
1SAMHSA Opioid Overdose Prevention Toolkit

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Product Description
Product Description
The Opioid Halo™ System is a monitoring solution designed to continuously monitor to help recognize
opioid induced respiratory depression (OIRD) while taking opioids. It uses Opioid Halo, a software, to
review your blood oxygen data to recognize when there may be trouble getting enough oxygen while on
opioids.
The Opioid Halo System includes the following pieces:
•Home Medical Hub – Device that communicates monitoring data wireless from the medical
technologies to provide visual/audible alerts.
•Masimo Sensor - Wireless wearable sensor that provides the monitoring data.
•Masimo Halo™ App - Software application installed on a smart phone that provides the
graphical user interface to display live monitoring data and alarm condition status.
•Opioid Halo - Software that runs continuously to provide real-time detection of the severe
Opioid-Induced Respiratory Depression (OIRD) risk based upon changes or patterns in your
oxygenation biomarker data (SpO2, PR, Pi).
•Notification Escalation Policy - Policy that is used to add levels of awareness through the
notification of Emergency contact or contracted Emergency Responders.
•Masimo SafetyNet Alert Cloud - A server accessed over the internet that gathers and
stores measured data communicated wirelessly from a Home Medical Hub.
Who the Device is intended for (Indications for Use)
The Opioid Halo™ System is intended to monitor and alarm when a patient may be experiencing an
opioid induced impairment of oxygenation.
The Opioid Halo™ System is indicated for the non-invasive continuous monitoring of individuals 15 years
and older for the identification of when they may be experiencing a substance induced impairment of
oxygenation (e.g., opioid induced respiratory depression caused by oral or injectable opioids) in hospital
and home environments.
Who the Device Should not be used on (Contraindications)
The Opioid Halo System is not indicated for users on supplemental oxygen greater than 2.0 L/min.

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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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•Do not soak any part of the system in liquid.
•Do not try to sterilize.
•Only use Masimo recommended solutions for cleaning your system. See Cleaning on page
63.
•Do not clean while device is in use.
CAUTION: Keep small parts away from small children. Small items can be a choking hazard.
CAUTION: Place the Home Medical Hub where you can easily disconnect it from AC power in case
the power needs to be disconnected.
CAUTION: Only use the AC power supply included with your Home Medical Hub to prevent damage
to the device.
CAUTION: Do not monitor more than one person at a time with the Opioid Halo System.
CAUTION: Use and store the Opioid Halo System as directed in the Specifications section in this
manual.
CAUTION: Only use Masimo-approved parts to make sure the device works correctly.
CAUTION: For your safety, do not try to repair a device that is damaged.
Masimo Sensor
CAUTION: The light on the sensor should be aligned so it shines directly with the sensor detector
through your finger. If misaligned, the performance of the sensor maybe impacted. Good sensor
placement should be confirmed by checking the following:
•Halo Indicator is green.
•Pulse Rate is displayed.
•Pulse Rate Waveform shows a clear pattern.
Refer to Troubleshooting on page 39 if readings do not display.
CAUTION: Select a finger free from injury, without nail polish to put on the sensor. Nail polish or finger
injury can affect how the light passes through the finger.
CAUTION: Avoid wrapping the sensor too tightly around your finger to avoid injury or restricting blood
flow to the finger.
CAUTION: To avoid skin injury, consider moving the sensor to another finger after it has been used
for more than 8 hrs. The non-dominant ring or middle finger is preferred.
CAUTION: Avoid light interference from bright light sources and direct sunlight when using the
Masimo Sensor. The interference can affect the sensor performance.

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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.
•Restricted blood flow to the sensor site.
•Sensor site has nail polish, acrylic nails, glitter, etc.
•A sensor site with moisture, birthmarks, skin discoloration, or foreign objects that block the
sensor.
•Placed near other devices that may interfere with its operation.
•Excessive movement of the sensor is present.
•Possible medical conditions (e.g., Obstructive Sleep Apnea).
CAUTION: To ensure proper notification function, check the following occasionally:
•Notification features is turned on your smart phone(i.e., sounds, vibrations, etc.)
•Smart phone battery is fully charged or plugged in.
•Halo indicator is active and green.
•Check your smart phone connection occasionally.
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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CAUTION: Keep the Home Medical Hub plugged in while in use. Loss of power may limit the
notifications available in case of an event.
CAUTION: Only use the AC power supply that came with the Home Medical Hub to prevent damage
to the device.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer.
CAUTION: When using the Opioid Halo System, locate the devices away from sources that may
interfere with the wireless communication. The presence of other devices that may create radio frequency
interference (RFI) may result in loss of Quality of Service of the wireless connection or loss of
performance (see Specifications for details). Devices that may cause RFI include but are not limited to
the following: cell phones, laptops and tablets, pagers, Bluetooth devices, devices with remote controls,
electrocautery equipment, diathermy equipment, and baby monitors.
CAUTION: To ensure security and prevent tampering of your mobile device, follow the directions
below:
•Smart phone should be located with responsible users.
•Smart phone should not be left unattended.
•Security features on smart phone should be activated.
CAUTION: Check your system setup by viewing the display on smartphone for the Masimo Halo App.
The Masimo Halo App will provide an indication if there is a problem with the internet connection.
For Supervisors or Caregivers
WARNING: Do not wait for an alarm. If you suspect someone is having an opioid overdose, call 911
and administer naloxone, if needed!
WARNING: If you suspect an opioid overdose, the CDC and SAMHSA recommend treating it as an
actual opioid overdose.
WARNING: Obstructive sleep apnea (OSA) can increase the risk of false OIRD alarms. The Opioid
Halo utilizes the instability trends in oxygenation biomarker data caused by opioid induced respiratory
depression (OIRD). OSA can also cause oxygenation instability trends that can be mistaken as OIRD.
However, if you suspect an opioid overdose, the CDC and SAMHSA recommend treating it as an actual
opioid overdose.
WARNING: When used for monitoring someone on supplemental oxygen, periodically check on their
breathing. High flow rates (>2.0 L/min) of supplemental oxygen can indicate high oxygen level readings
even if they are having trouble breathing. The Opioid Halo System is not indicated for O2flow rates >2.0
L/min.
CAUTION: Relocate the Home Medical Hub if necessary. However, keep the Home Medical Hub in
the line of site of the sensor to ensure the most reliable Bluetooth connection.

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Cleaning and Service
•Do not attempt to remanufacture, recondition, or recycle the Masimo sensor, Masimo chip or
Home Medical Hub. to prevent harm or damage to the system.
•Always turn off and unplug the Home Medical Hub before cleaning to prevent harm or
damage to the device.
•Do not clean Masimo sensor, Masimo chip or Home Medical Hub with undiluted bleach,
petroleum-based products, acetone, or other harsh solvents. Clean only with the solutions
specified in this manual to prevent damage to the device.
•Do not submerge Masimo sensor, Masimo chip or Home Medical Hub in liquid or attempt to
sterilize by any method to prevent damage to the device.
Radio Compliance
WARNING: Changes or modifications not approved by Masimo can void the user’s authority to
operate the equipment.
•Only use Masimo authorized devices with the Opioid Halo System. Using unauthorized
devices with the Opioid Halo System may result in damage to the device and/or patient
injury.
•The frequency bands of this device (2.4 GHz and 5.15 to 5.25 GHz) are only for indoor use in
accordance with international telecommunication requirements.
•Disposal of product: Comply with local laws when disposing of the device and/or its
accessories.
•Do not place the Opioid Halo System components near electrical equipment that may affect
the device, preventing it from working properly.
Note: The Opioid Halo System complies with the limits for a Class B digital device, per Part 15 of the
FCC Rules. These limits were designed to provide reasonable protection against harmful interference in a
residential installation. The Opioid Halo System generates, uses, and can radiate radio frequency energy
and may cause interference with radio communications. To determine if the Opioid Halo System
interferes with radio or television reception, turn it off and see if the interference stops. To correct the
interference, try the following:
•Adjust or move the receiver’s antenna.
•Move the receiver farther away from the Opioid Halo System.
•Plug the receiver and the Opioid Halo System into outlets on different circuits.
•Consult the dealer or a radio/TV technician for help.
Note: This equipment has been tested and found to comply with the Class B limits for medical devices
according to the IEC 60601-1-2: 2014, Medical Device Directive 93/42/EEC. These limits are designed to

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provide reasonable protection against harmful interference in all establishments, including domestic
establishments.
Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Note: To satisfy RF exposure requirements, this device and its antenna must operate with a separation
distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with
any other antenna or transmitter.
Note: When using the Opioid Halo System consideration should be taken to local government frequency
allocations and technical parameters to minimize the possibility of interference to/from other wireless
devices.
Risks and Benefits
Opioid Induced Respiratory Depression (OIRD)
One of the side effects of opioids is the risk of OIRD. OIRD affects your body’s ability to work normally
including breathing.
When OIRD occurs and you stop breathing, your blood oxygen level can drop or desaturate or become
very unstable. Without enough oxygen in your blood, your brain, organs, and tissues can be damaged
and may fail.
The Opioid Halo System provides Opioid Halo that works to monitor your blood oxygenation biomarker
data (e.g., SpO2, Pulse Rate) to detect severe risk for OIRD. The Opioid Halo analyzes the stability of
your oxygenation to detect a risk of an opioid overdose. Because other medical conditions can also
cause instability in your oxygenation (e.g., obstructive sleep apnea), you may also get an alarm for an
oxygenation issue that is not opioid related. Regardless, if there is an alarm and you suspect or know
someone has taken opioids it is better to act as if they maybe having an opioid overdose.
According to US CDC1, the recognition of opioid overdoses can be difficult. If unsure it is best to treat the
situation like an overdose - it could save a life. Call 911 or seek medical care for the individual. Do not
leave the person alone. Signs of overdose may include:
•Small, constricted "pinpoint pupils"
•Falling asleep or loss of consciousness
•Slow, shallow breathing
•Choking or gurgling sounds
•Limp body
•Pale, blue, or cold skin
1https://www.cdc.gov/opioids/overdoseprevention/index.html

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Risks of Opioid Halo
•Supplemental oxygen greater than 2.0 L/min will add oxygen to the blood. This may delay
the detection of OIRD.
•Opioids can stop breathing immediately. In these cases, the Opioid Halo may not alarm soon
fast enough. Make sure that anyone providing supervision is aware of signs of opioid
overdose and understands how to help.
•Because there are skin-contacting components, there is a risk of skin irritation, pressure
injury, and general discomfort while a sensor or cuff is applied to a user. Periodically check
the areas where the user’s skin contacts with the sensor or blood pressure cuff to prevent
potential issues.
Benefits of Opioid Halo
•The Opioid Halo System is equipped with audible and visual physiological alarms that can
alert potential opioid overdose.
•The Opioid Halo System can add your emergency contacts to provide increased awareness
to an opioid overdose.
•The Opioid Halo System can trigger a wellness call if your oxygenation is showing signs of
an opioid overdose.

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Description
Opioid Halo System
These items make up the Opioid Halo System:
Item Description
1Home Medical Hub
2Masimo Halo App (smart phone not included)
3Masimo Sensor
4Masimo Chip

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Features
Features of the Opioid Halo System.
Home Medical Hub Overview
The Home Medical Hub is a device that transfers measured data from the wireless Masimo Sensor to the
Masimo SafetyNet Alert Cloud. It transfers data from the wireless Masimo Sensor to the Masimo
SafetyNet Alert Cloud and provides audible and visible alarms.
1. Pairing Symbol
Location on the Home Medical Hub for pairing the
Masimo Chip.
2. Home Medical Hub Button
Used for pairing and silencing alarms.
3. Bluetooth Status LED
Shows the Home Medical Hub Bluetooth status. See
Home Medical Hub Lights on page 49.
4. Home Medical Hub Status LED
Shows the Home Medical Hub power and monitoring
status. See Home Medical Hub Lights on page 49.
5. Wi-Fi Status LED
Shows the Home Medical Hub Wi-Fi status.
See Home Medical Hub Lights on page 49.
6. USB Power Connector
Power is provided to the Home Medical Hub
from the AC adapter and a USB cable.
7. Masimo Chip Storage Tray
Location on the Home Medical Hub for storage
of the chip when not in use.