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.).

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•Smart device battery is fully charged or plugged in.
•Oxygen values are displayed on the App live view.
CAUTION: Do not place your smart phone where someone can change the App settings without
you knowing.
CAUTION: Avoid using Masimo SafetyNet Alert under bright light sources and direct sunlight to
maintain the performance of the device.
CAUTION: Check that the Masimo SafetyNet Alert 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.
CAUTION: Keep the Home Medical Hub plugged in while in use. Loss of power may limit the
notifications available.
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 Masimo SafetyNet Alert, locate the devices away from sources that may
interfere with the Bluetooth connection. The presence of other devices that may create radio
frequency interference (RFI) may result in loss of Quality of Service of the Bluetooth connection
(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 smart phone, while using the
Masimo SafetyNet Alert:
•Smart device should be located with responsible users.
•Smart device should not be left unattended.
•Security features on smart device should be activated.
•Unauthorized changes should not be made to the Masimo SafetyNet Alert system.
CAUTION: Check your setup by viewing the display on the App and the Home Medical Hub. The
App and Home Medical Hub will provide an indication if there is a problem with the internet
connection.

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CAUTION: Check your system setup by viewing the display on the smartphone Masimo SafetyNet
Alert Application. The Masimo SafetyNet Alert App will provide an indication if there is a problem
with the internet connection.
CAUTION: Avoid placing Masimo SafetyNet Alert near other wireless devices to prevent loss of
performance.
Masimo Sensor
WARNING: Properly apply the Masimo Sensor according to sensor's Directions for Use. Applying
the sensor incorrectly could result in incorrect or no readings.
CAUTION: Avoid using Masimo Sensor under bright light sources and direct sunlight to maintain
the performance of the device.
CAUTION: To maintain Bluetooth connectivity with the Masimo Sensor, ensure that the Home
Medical Hub is within the specified distance and in line-of-sight of the Masimo Sensor. See
Specifications on page 51.
Cleaning and Service Warnings
WARNING: 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.
WARNING: Always turn off and unplug the Home Medical Hub before cleaning to prevent harm
or damage to the device.
CAUTION: 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.
CAUTION: 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.
Compliance Warnings
WARNING: Changes or modifications not approved by Masimo can void the user’s authority to
operate the equipment.

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WARNING: 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.
WARNING: Only use Masimo authorized devices with Masimo SafetyNet Alert. Using
unauthorized devices with Masimo SafetyNet Alert may result in damage to the device and/or
patient injury.
WARNING: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
Masimo SafetyNet Alert, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this equipment could result.
CAUTION: Disposal of product: Comply with local laws when disposing the device and/or its
accessories.
CAUTION: Do not place the Masimo SafetyNet Alert near electrical equipment that may affect the
device, preventing it from working properly.
CAUTION: To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be near Masimo SafetyNet Alert.
CAUTION: Keep the Masimo SafetyNet Alert away from electrical equipment that emits radio
frequencies to minimize radio interference. Radio interference may result in no or inaccurate
readings.
Note: Masimo SafetyNet Alert 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. Masimo SafetyNet Alert generates, uses, and can radiate
radio frequency energy and may cause interference with radio communications. To determine if
Masimo SafetyNet Alert 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 Masimo SafetyNet Alert.
•Plug the receiver and Masimo SafetyNet Alert 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. These limits are designed to provide reasonable
protection against harmful interference in all establishments, including domestic establishments.

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Note: This device complies with part 15 of the FCC Rules and Industry Canada’s license-exempt
RSS standards. 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: This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2) this
device must accept any interference, including interference that may cause undesired operation
of the device.
Note: Users are advised that high-power radars are allocated as primary users (i.e., priority users)
of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause
interference and/or damage to LE-LAN devices.
Note: When using Masimo SafetyNet Alert 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
Your Body and Oxygen
When we breathe, oxygen moves in our blood around our body. When we are healthy or not
fatigued, our lungs are able to bring the oxygen needed by our brain, organs, and tissue. As the
state of our body is always changing, it is common to see continual fluctuations in your blood
oxygen over time.
However, when we are sick, fatigued, or having trouble breathing, the body can require more
oxygen than can be delivered. When this occurs, your blood oxygen level can drop. These changes
cannot be seen, but if our oxygen gets too low, you may feel the effects such as being
lightheaded, dizzy, or having difficulty breathing. If your oxygen level stays too low for too long,
the lack of oxygen to your brain, organs, and tissue or hypoxia can have serious long-term effects
to your health including death.

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The Masimo SafetyNet Alert allows you to see your oxygen level so that you can understand how
your body and oxygen are connected.
If you have a medical condition that effects your breathing (e.g., asthma, COPD), your normal
blood oxygen level may be lower. For these conditions, it is important that you seek the advice of
your physician.
For other conditions where your blood oxygen becomes low, it is good to remember that our
blood oxygen is connected to our breathing and always changing.
If you have any concerns that your oxygen level is constantly decreasing, staying low, or you are
not feeling well, it is very important to not self-diagnosis and seek the advice of your physician.
When using any medical device, there are risks and benefits.
Risks of Masimo SafetyNet Alert
•As with all medical electrical devices, there is always a risk of electrical, mechanical,
and fire hazards. However, these risks have been mitigated through the design and
testing of Masimo SafetyNet Alert.
•As with all devices with small parts, there is always a risk of a child’s swallowing a
component or choking. Keep small parts away from small children to prevent
swallowing or choking.
•Items applied directly to the skin may cause skin irritation, pressure injury, or general
discomfort. Periodically check the area where the Masimo sensor is applied to prevent
potential irritations.
•As with all types of alarms, there is always a risk of missing or not hearing an alarm. To
minimize this risk, ensure Masimo SafetyNet Alert is placed where it can be heard and
the speaker is not blocked by other objects.
•As with all types of alarms, there is always a risk of false alarms. To minimize false
alarms, ensure you follow all device and Masimo sensor directions, and follow
troubleshooting instructions. Never assume an alarm is false; promptly address every
alarm.

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Benefits of Masimo SafetyNet Alert
•Masimo SafetyNet Alert has the ability to monitor wirelessly without being tethered to
a monitor. This allows users the freedom of movement during activities, including
sleep, not conveniently possible with a cabled connection.
•Masimo SafetyNet Alert is equipped with audible and visual physiological alarms that
can alert you to changes in the user’s condition while monitoring within a home
environment.
•Masimo SafetyNet Alert uses the same proven pulse oximetry used in hospitals shown
to have fewer false alarms1compared to other brand technology.
•Masimo SafetyNet Alert allows for the storage and review of your blood oxygen level as
you go about your normal activities, including exercise or sleep.
1Barker S.J. Anesth Analg. 2002 Oct;95(4):967-72.

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Description
Masimo SafetyNet Alert System
The Masimo SafetyNet Alert system consists of the following:
Item Description
1Home Medical Hub
2Smart phone with Masimo SafetyNet Alert App Installed*
3Masimo Sensor
4Masimo Chip
* Smart phone not included.

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Features
The following describes the Masimo SafetyNet Alert system parts.
Home Medical Hub Overview
The Home Medical Hub is a device that transfers measured data from the wireless Masimo Sensor
to the Masimo Cloud. It transfers data from the wireless Masimo Sensor to the Masimo 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 17.
4. Home Medical Hub Status LED
Shows the Home Medical Hub power and monitoring
status. See
Home Medical Hub Lights on page 17.
5. Wi-Fi Status LED
Shows the Home Medical Hub Wi-Fi status. See
Home Medical Hub Lights on page 17.
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.

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Home Medical Hub Lights
The LED lights on the Home Medical Hub show the status of Bluetooth pairing and Wi-Fi
connections.
Indicator/LED Color What does it mean?
Home Medical Hub Status LED
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 Cloud.
Flashing Orange Active Level 1 Alert. See Alarms and Notifications on page 30.
Solid Orange Level 1 Alert is acknowledged.
Flashing Red Active Level 2 or 3 Alert. See Alarms and Notifications on page 30.
Solid Red Level 2 or 3 Alert is acknowledged.
Flashing Orange Sensor battery ports are blocked.
Flashing Red A Home Medical Hub fault has been detected.
Bluetooth Status LED
Solid White Home Medical Hub is on and needs to be set up.
Off Home Medical Hub is paired with the sensor.
Flashing White Home Medical Hub is pairing with the sensor.
Solid Orange Sensor is disconnected from the Home Medical Hub.
Wi-Fi Status LED
Solid White Home Medical Hub is on and needs to be set up.
Off 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.

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Masimo Sensor and Masimo Chip Overview
The Masimo Sensor and Masimo Chip are for use with the Masimo SafetyNet Alert system.
1. Masimo Sensor
a. Cable
b. Chip Holder
c. Strap
d. Sensor LED
e. Detector
f. Tape
2. Masimo Chip
a. Light Indicator
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.
Flashing Purple Sensor battery ports are blocked.
Flashing Green Sensor is not paired with the Home Medical Hub.
Flashing Orange Sensor battery is low.
Flashing Red Sensor battery is very low.