Masimo Opioid Halo User Manual
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Masimo Opioid Halo User Manual

Masimo Opioid Halo User Manual

Opioid overdose prevention and alert system
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Summary of Contents for Masimo Opioid Halo

  • Page 3 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.

  • Page 5: Table Of Contents

    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 ....................................
  • Page 6 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 ..................................

  • Page 7: About This Manual

    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.
  • Page 8 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.

  • Page 9: Preventing Opioid Overdoses (Samhsa)

    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.

  • Page 11: Product Description

    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.

  • Page 12: Safety Information

    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.
  • Page 13 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.

  • Page 14: Performance Warnings

    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.

  • Page 15: For Supervisors Or Caregivers

    • 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...

  • Page 16: Cleaning And Service

    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.

  • Page 17: Risks And Benefits

    The Opioid Halo System provides Opioid Halo that works to monitor your blood oxygenation biomarker data (e.g., SpO , 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...

  • Page 18: Risks Of Opioid Halo

    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.

  • Page 19: Description

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

  • Page 20: 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.
  • Page 21 Masimo Sensor and Chip Overview The Masimo Sensor and Masimo Chip are for use with the Opioid Halo system. 1. Masimo Sensor a. Cable b. Chip Holder c. Strap d. Sensor LED e. Detector f. Tape 2. Masimo Chip a. Light Indicator...

  • Page 23: Basic Setup And Use

    To use your smart phone with the Masimo Halo App check the following: Compatibility • Note: For a list of smart phones and operating systems that work with the Masimo Halo App, check www.masimo.com/support before upgrading the smart phone or its operating system. Smart Phone Battery is charged •...

  • Page 24: Step 2: Opioid Halo System Setup

    Note: If the Masimo Halo App requests for the smart phone to share its location, select OK or Allow. The smart phone location is required for Bluetooth connection.
  • Page 25 Home Medical Hub Setup Follow the instructions below to set up the Opioid Halo system. The Home Medical Hub is set up in two (2) steps. Step 1: Pair the Masimo Halo App to the Home Medical Hub using Bluetooth.
  • Page 26 Insert the Masimo Chip into the sensor. • Attaching the Wireless Masimo Sensor Follow the instructions to attach the Masimo Sensor to your hand. An in-app video is provided showing proper sensor application. Gather all components required for monitoring. See Masimo Sensor and Chip Overview on page 19.
  • Page 27 Place the sensor on the wrist as shown and carefully thread the tip of the strap through the open red c loop. Wrap the loose attachment strap around the wrist and press to secure. Remove part of the plastic film and place the star on top of the fingernail of your finger.
  • Page 28 Wrap the tape around your finger so the square marking on the sensor tape is centered marking on the fingernail. Ensure on the finger pad directly across from the star alignment between the square marking and star is correct; reposition as necessary.
  • Page 29 Adjust the sensor cable to a comfortable length. Pairing the Masimo Sensor To pair the Masimo Sensor to the Home Medical Hub, hold the chip near the Home Medical Hub pairing symbol until an audible beep is heard and the Home Medical Hub Bluetooth LED...
  • Page 30 Insert the Masimo Chip into open compartment on the sensor. Press down on the Masimo Chip to secure. Listen for a click and look for a green light on the chip to confirm successful chip connection to sensor. Confirm successful pairing once the chip is inserted into the sensor by observing the light indicators.
  • Page 31 Masimo Sensor Operation Reapplying the Sensor The Masimo Sensor may be reapplied to the same user if the emitter and detector windows are clear, and the adhesive still sticks to the skin. Use the replacement tape when the adhesive no longer sticks.
  • Page 32 Follow the on-screen prompts to select your Emergency Contacts from your smart phone. This allows the Masimo Halo App to contact them in case of an emergency. An emergency contact is someone who will be alerted if you experience an Alert event.
  • Page 33 Enable Emergency Dispatch Services Follow the on-screen prompts to allow Emergency Dispatch Services to be notified if a low oxygen event occurs. When prompted, select I Agree. Note: If you Opt Out, you agree to take full responsibility for contacting EMS if the need arises.

  • Page 34: Step 3: Live Data

    Step 3: Live Data After setting up the Opioid Halo system, the app displays data from the Masimo Sensor. The Live screen is also the App Main Screen, with access to other Masimo Halo App functions. 1. App Menu Displays the App Menu screen.
  • Page 35 Opioid Halo continuously monitors your blood oxygen data patterns. Three different alarm levels (Level 1, Level 2, and Level 3) help to identify the risk of severe OIRD. When correctly configured, Opioid Halo will audibly and visually alarm at the Home Medical Hub and your phone (Level 1). Will additionally notify your emergency contacts (Level 2).
  • Page 36 Caution of OIRD risk due to early signs of unstable oxygenation being detected or low levels of oxygen. Touch the CAUTION Opioid Halo Indicator (1) or the CAUTION banner (2) to view how to respond (alarm will be silenced for 2 minutes or until a higher level alarm is triggered).
  • Page 37 Level 2 Notification Trigger Visual Audible Emergency Emergency Level Alarm Alarm Contact Dispatch Medically meaningful or very Message sent to unusual signs of unstable Warning Level 2 Emergency oxygen levels or sustained (Red) Contacted Contact low levels of oxygen. When Level 2 is triggered, an alarm will sound on the Home Medical Hub and the App.
  • Page 38 Touch the WARNING Opioid Halo Indicator (1) or the WARNING banner (2) to view how to respond (alarm will be silenced for 2 minutes or until a higher level alarm is triggered). What to Do in case of an Opioid Overdose: •...
  • Page 39 Touch the EMERGENCY Opioid Halo Indicator (1) or the EMERGENCY banner (2) to view how to respond (alarm will be silenced for 2 minutes).
  • Page 40 Silence Alarms An audio alarm can only be silenced for 2 minutes. After the 2 minutes, the alarm sounds again. You can continue to temporarily silence the alarm for 2 minutes at a time if the low oxygen level condition continues.

  • Page 41: Troubleshooting

    Troubleshooting Opioid Halo Messages The following section is intended to provide guidance for solving some of the most common issues users may face with the Opioid Halo System. Displayed Messages Potential Causes Next Steps Difficulty in obtaining a There is an issue with getting your reading. Please "Difficulty in obtaining a...
  • Page 42 Follow instructions on the setup section of this Disconnected during an Home medical Hub manual to complete setup. alert" during an alarm event. If you still experience issues, please contact Masimo Technical Support. See Contacting Masimo on page 64.
  • Page 43 Home Medical Hub. disconnected from • Please check your Wi-Fi Network to ensure the the sensor. App can connect to the Masimo SafetyNet Alert • The App has Cloud. disconnected from If you still experience issues, please contact Masimo the Masimo Technical Support.

  • Page 44: Troubleshooting Opioid Halo

    Operator's Manual or Directions for Use. does not turn on • Masimo Halo App needs • Check for Masimo Halo App updates. to be updated. • Check compatibility for your Smart phone. See • Incompatible smart Specifications on page 47.
  • Page 45 • Check network settings and availability. You may Cloud may be down. need to call the network provider for further assistance. • Contact Masimo Customer Support. See Contacting Masimo on page 64. • The Home Medical Hub • Ensure the Home Medical Hub is plugged in.
  • Page 46 • Update the smart phone software. Refer to the smart phones Operator's Manual or Directions for Use. • Contact Masimo Customer Support. See Contacting Masimo on page 64. • Incorrect user currently • Ensure the correct user is logged into the Incorrect user data is logged into Opioid Halo.
  • Page 47 Symptom Potential Causes Next Steps • Incorrect user currently • Ensure Opioid Halo is connected to Wi-Fi. User alarms do not logged into the App. • Ensure the correct user is logged into Masimo appear during events • Wi-Fi network not Halo App.

  • Page 48: Troubleshooting Measurements

    Hub not plugged into AC • Shield the sensor from excessive or strobing light. power supply. • Replace sensor. • Contact Masimo Customer Support. See Contacting Masimo on page 64. • Measurement may still be • Allow time for the parameter measurement to Measurement in progress.

  • Page 49: Appendix

    For full list of compatible devices go to www.masimo.com/support Masimo Sensor Sensor Lights When inserted in the sensor, the light indicator on the Masimo Chip shows the status of the sensor. Light Indicator Color What does it mean? Flashing Blue Sensor is paired with the Home Medical Hub.
  • Page 50 Approximately two-thirds of the device measurements fell within +/- A of the reference measurements in a controlled study. Electrical Battery - Masimo Sensor Run Time 96 hours in typical continuous usage Environmental Masimo Sensor Environmental Conditions Operating Temperature 32°F to 104°F (0°C to 40°C) Storage Temperature 32°F to 122°F (0°C to 50°C)
  • Page 51 Solid White Home Medical Hub is on and needs to be set up. Solid Green Home Medical Hub is paired with the sensor, connected to the Wi-Fi and communicating with the Masimo SafetyNet Alert Cloud. Flashing Orange Active Level 1 Alert. See Alarms and Notifications on page 33.
  • Page 52 Indicator/LED Color What does it mean? Home Medical Hub is connected to the Wi-Fi network. Flashing White Home Medical Hub is searching for or connecting to the Wi-Fi network. Solid Orange Home Medical Hub is connected to the Wi-Fi and the Sensor is no longer connected. Electrical AC Power Requirements AC Power Input (External Power Supply) 100 to 240 VAC, 50 to 60 Hz, 1.2 A...
  • Page 53 After entering a monitoring a state and the sensor is disconnected from the Home Medical Hub and Masimo Halo App Server Disconnected High After entering a monitoring a state and the Home Medical Hub disconnected from Masimo SafetyNet Alert Cloud Monitoring with Alarm High...
  • Page 54 IP22 (Protection from solid foreign objects ≥12.5 mm diameter and against ingress from vertically falling water drops when enclose tilted up to 15°) Masimo Chip IP47 (Protection from solid foreign objects <1 mm diameter and against immersion between 15 centimeters and 1 meter in depth)
  • Page 55 Oxygen Level (SpO2) Performance Specifications The tables below provide A (Accuracy Root Mean Square) values measured using the Radius PPG sensors under no motion, with Masimo Technology in a clinical study. Measurement A Values for Radius PPG Sensors Accuracy Range (%)
  • Page 56 Figure 1: Residual plot with repeated measures adjusted LOA for overall flattened dataset Opioid Halo Performance Testing The Opioid Halo Performance was tested for 2 things: 1. How well severe OIRD was detected or “sensitivity”. 2. How well it doesn't falsely detect severe OIRD or “specificity”. The sensitivity and specificity can be a number between 0-100%.
  • Page 57 Opioid Halo performance. Those cases breakdown to 135 Home Prescribed Naïve, Chronic), 242 Hospital, and 264 Illicit. The Naïve, Chronic, and Hospital Opioid data came from pulse oximeter recordings using a Masimo SET pulse oximeter.
  • Page 58 Sensitivity and Specificity Performance by Opioid Type The table below shows how well the Opioid Halo alarms were able to detect severe OIRD due to different types of opioids in a hospital setting. Delivery Medication OIRD Sensitivity Specificity Method Events Halo –...
  • Page 59 Delivery Medication OIRD Method Events Halo – Halo – Halo – Halo – Halo – Halo – Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Fentanyl Rx 13.2% 30.4% 84.6% 100.0% 100.0% 99.8% Hydromorphone 16 3.5% 8.7% 29.3% 100.0%...
  • Page 60 Guidance and Manufacturer's Declaration - Electromagnetic Immunity Surge +/-1 kV line(s) +/-1 kV line(s) to Mains power quality should be that of a typical commercial IEC 61000-4-5 to line(s) line(s) or hospital environment. +/- 2 kV line(s) +/- 2 kV line(s) to to earth earth Voltage dips, short...
  • Page 61 Guidance and Manufacturer's Declaration - Electromagnetic Immunity a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 62 Test Band Service (a) Modulation (b) Maximum Distance Immunity Test Frequency Power Level (MHz) (MHz) (V/m) Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. (a) For some services, only the uplink frequencies are included.
  • Page 63 Identifies unit has been registered as a Innovation, Science and Economic radio device Development Canada (ISED) Caution Warning Product contains no PVC (polyvinyl chloride) material Not made with natural rubber latex Manufacturer Date of manufacture Catalog number (model number) YYYY-MM-DD Masimo reference number Storage temperature range...
  • Page 64 5% for saturations ranging from 70% to 100%. [4] The Masimo SET Technology has been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%.

  • Page 65: Service And Maintenance

    The Home Medical Hub and Masimo Chip are reusable devices. The devices are supplied and used non- sterile. The Masimo Chip should be cleaned before and after it has been applied to a user and/or in accordance with local and governmental regulations to minimize the risk of cross-contamination.
  • Page 66 • Customer Support For answers to frequently asked questions (FAQ's) and product support, along with troubleshooting for your Opioid Halo product, please go to www.masimo.com/support or email customercare@masimo.com. Return and Warranty For repair, warranty and returns policy refer to https://www.masimopersonalhealth.com/pages/warranty- returns or contact Masimo Customer Support.

  • Page 67: Concepts Of Alarm Response Delay

    Concepts of Alarm Response Delay As with any pulse oximeter equipment, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists.

  • Page 69: Index

    Masimo Chip • 48 Concepts of Alarm Response Delay • 65 Masimo Chip Cleaning • 63 Contacting Masimo • 39, 40, 41, 42, 43, 44, 45, 46, 64 Masimo Halo App • 47 Customer Support • 64 Masimo Sensor • 11, 47 Masimo Sensor and Chip Overview •...
  • Page 70 Recommended Separation Distances • 60 Wireless Specifications • 52 Return and Warranty • 64 Risks and Benefits • 15 Risks of Opioid Halo • 16 Safe Use Information • 10 Safety Information • 10, 46 Sensor Lights • 47 Service and Maintenance • 63 Silence Alarms •...
  • Page 72 303395/LAB-11524B-0423...

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