Masimo SafetyNet Alert User manual

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For Export Only, Not for Sale in the USA
There may be information provided in this manual that is not relevant for your system. Do not
operate Masimo SafetyNet Alert 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
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Patents: www.masimo.com/patents.htm
Masimo® and ® are federally registered trademarks of Masimo Corporation.
Masimo SafetyNet™ and Masimo SafetyNet Alert™ are trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2022 Masimo Corporation

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Contents
About This Manual.................................................................................................................. 5
Getting Started Guides...................................................................................................... 5
In-App Videos.................................................................................................................... 5
Product Description and Intended Use................................................................................. 5
Product Description ........................................................................................................... 5
Who the Device is intended to be used on (Indications for Use)................................... 6
Intended Use ................................................................................................................ 6
Indications for Use ........................................................................................................ 6
Contraindications.......................................................................................................... 6
Safety Information.................................................................................................................... 7
Safety Warnings.................................................................................................................. 7
Masimo Sensor............................................................................................................. 8
Performance Warnings...................................................................................................... 8
Masimo Sensor...........................................................................................................10
Cleaning and Service Warnings .....................................................................................10
Compliance Warnings.....................................................................................................10
Risks and Benefits .................................................................................................................. 12
Your Body and Oxygen................................................................................................... 12
Risks of Masimo SafetyNet Alert..................................................................................... 13
Benefits of Masimo SafetyNet Alert................................................................................ 14
Description .............................................................................................................................15
Masimo SafetyNet Alert System ..................................................................................... 15
Features ............................................................................................................................ 16

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Home Medical Hub Overview.................................................................................. 16
Masimo Sensor and Masimo Chip Overview.......................................................... 18
Basic Setup and Use.............................................................................................................. 19
Getting Started................................................................................................................. 19
Step 1: Smart Phone Setup ............................................................................................. 19
Step 2: Masimo SafetyNet Alert System Setup.............................................................. 21
Home Medical Hub Setup ........................................................................................ 21
Masimo Sensor Setup................................................................................................ 22
Add Emergency Contacts......................................................................................... 28
Step 3: View Live Data..................................................................................................... 29
Alarms and Notifications............................................................................................30
Advanced Use .......................................................................................................................35
Health Settings .................................................................................................................35
Change Option ..........................................................................................................35
Oxygen Level.............................................................................................................. 36
Troubleshooting.................................................................................................................... 39
Masimo SafetyNet Alert Messages ................................................................................ 39
Troubleshooting Masimo SafetyNet Alert..................................................................... 45
Troubleshooting Measurements....................................................................................50
Appendix................................................................................................................................ 51
Specifications.................................................................................................................... 51
Masimo SafetyNet Alert App .................................................................................... 51
Masimo Sensor........................................................................................................... 51
Masimo Chip .............................................................................................................. 54
Home Medical Hub ...................................................................................................54

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Symbols.......................................................................................................................63
Citations....................................................................................................................... 64
Service and Maintenance................................................................................................ 65
Cleaning...................................................................................................................... 65
Customer Support...................................................................................................... 66
Concepts of Alarm Response Delay ..............................................................................67
Index ....................................................................................................................................... 69
About This Manual
Getting Started Guides
Use the quick reference guide included for the following:
•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 Masimo SafetyNet Alert System.
•Masimo Sensor placement.
•Connecting your Masimo SafetyNet Alert System to WiFi.
Product Description and Intended Use
Product Description
Masimo SafetyNet Alert - a system that provides spot-checking and continuous monitoring of
physiological data by wireless communication to medical technologies. The system includes the
following pieces:
Masimo SafetyNet Alert App - software application installed on a smart phone that provides
the graphical user interface to display your data and alarm condition status.

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Masimo Sensor - wireless, wearable sensor that provides the physiological data.
Masimo Chip - attaches to the wireless Masimo Sensor and connects wirelessly to the Home
Medical Hub.
Home Medical Hub - device that communicates monitoring data wirelessly from the medical
technologies to the Masimo Cloud.
Masimo Cloud - a server accessed over the internet that gathers and stores measured data
communicated wirelessly from the Home Medical Hub.
Who the Device is intended to be used on
(Indications for Use)
Intended Use
The Masimo SafetyNet Alert is intended for the continuous monitoring of physiological
parameters through communication to compatible medical technologies. Collected data from
compatible sensors are transferred and displayed via the subject device, providing a system that
allows physicians to monitor levels of SpO2 desaturation notifications.
Indications for Use
The Masimo SafetyNet Alert is intended for the continuous monitoring of physiological
parameters through communication to compatible medical technologies.
The Masimo SafetyNet Alert is indicated for the continuous monitoring of functional oxygen
saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in adult, pediatric, infant, and
neonates during motion, no-motion and low perfusion conditions in hospital and home
environments.
The Masimo SafetyNet Alert is also indicated for the monitoring of adults and pediatrics for
substance induced oxygen desaturations (e.g. OIRD caused by oral or injectable opioids) in
hospital and home environments.
Contraindications
Masimo SafetyNet Alert is contraindicated for the monitoring of opioid users on supplemental
oxygen greater than 2.0 L/min.

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Safety Information
Before using the Masimo SafetyNet Alert, read the following safety information carefully.
Safety Warnings
WARNING: For safe use, do not use if it appears damaged.
WARNING: For your safety, do not try to repair a device that is damaged.
WARNING: Place the Home Medical Hub where it will not fall on anyone.
WARNING: Make sure the oxygen level is displayed to ensure that monitoring has started.
WARNING: For safe use avoid the following:
•Do not place the Home Medical Hub on a wet surface.
•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 65.
•Do not clean while the device is in use.
WARNING: Keep small parts away from small children. Small items can be a choking hazard.
WARNING: Carefully position any cables to avoid possible strangulation or entanglement.
WARNING: Do not place the Home Medical Hub in areas where there are a lot of flammable
gases such as anesthetics, oxygen, or nitrous oxide present to prevent risk of fire.
WARNING: During defibrillation, avoid contact with any devices applied to the person to prevent
electric shock.
CAUTION: Place the Home Medical Hub where you can easily disconnect it from AC power in case
of an emergency.
CAUTION: Only use the AC power supply included with your Home Medical Hub to prevent
damage to the device.
Note: Do not monitor more than one person at a time with Masimo SafetyNet Alert.

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Masimo Sensor
WARNING: Avoid wrapping the sensor too tightly around your finger to avoid injury.
WARNING: To avoid skin injury, consider moving the sensor to another finger after it has used
more than 8 hrs.
Performance Warnings
WARNING: Do not self-diagnose or self-medicate on the basis of the measurements. Always
consult your physician.
WARNING: Do not use Masimo SafetyNet Alert as an apnea monitor. Masimo SafetyNet Alert is
not designed to detect apnea.
WARNING: Only use Masimo-approved parts with Masimo SafetyNet Alert to make sure the
device works correctly.
WARNING: Check your device is working before use for longer periods by checking to see your
starting oxygen level.
WARNING: Avoid placing liquids on or near the Home Medical Hub. Liquids spilled on Masimo
SafetyNet Alert may affect how it works.
WARNING: Do not place anything on top of the Home Medical Hub to avoid damaging or
blocking the wireless signal or muffling the audible alarms.
WARNING: The following factors can cause false oxygen measurements:
•Sensor is applied incorrectly.
•Restricted blood flow to the sensor site.
•Sensor site has nail polish, acrylic nails, glitter, etc.
•Sensor site has moisture, birthmarks, skin discoloration, or foreign objects.
•Placed near other devices that may interfere with its operation.
•Excessive movement of the sensor is present.
•Possible medical conditions that might interfere with readings.
WARNING: To ensure proper notification function, check the following occasionally:
•Notification features is turned on your Smart device (i.e., sounds, vibrations, etc.).