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