Masimo Stork User manual

User's Manual
Masimo Stork™

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There may be information provided in this manual that is not relevant for your system. Do not operate
Masimo Stork 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 TBD
Contains IC: 21098-ESP32SOLO1; IC: 7362A-CONNHUB TBD
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 Stork™ 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......................................................................................................................................................................4
Getting Started Guides........................................................................................................................................................4
In-App Videos .......................................................................................................................................................................4
Product Description and Intended Use...................................................................................................................................4
Product Description..............................................................................................................................................................4
Who the Device is intended to be used on (Indications forUse)...............................................................................5
Safety Information........................................................................................................................................................................5
Safety Warnings................................................................................................................................................................... 5
Performance Warnings ......................................................................................................................................................6
Cleaning and Service Warnings.......................................................................................................................................8
Compliance Warnings........................................................................................................................................................9
Risks and Benefits.....................................................................................................................................................................11
Your Body and Oxygen....................................................................................................................................................11
Risks of Masimo Stork ......................................................................................................................................................11
Benefits of Masimo Stork..................................................................................................................................................12
Description...................................................................................................................................................................................13
Masimo Stork System.......................................................................................................................................................13
Features...............................................................................................................................................................................13
BasicSetup and Use................................................................................................................................................................17
Getting Started....................................................................................................................................................................17
Step 1: Smart Phone Setup.............................................................................................................................................17
Step 2: Masimo Stork System Setup ............................................................................................................................18
Step 3: View Live Data......................................................................................................................................................25
Advanced Use ...........................................................................................................................................................................31

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Health Settings...................................................................................................................................................................31
Bottom Navigation............................................................................................................................................................. 31
Troubleshooting......................................................................................................................................................................... 33
Masimo Stork Messages.................................................................................................................................................33
Troubleshooting Masimo Stork.......................................................................................................................................38
Troubleshooting Measurements....................................................................................................................................41
Appendix.....................................................................................................................................................................................43
Specifications......................................................................................................................................................................43
Service and Maintenance................................................................................................................................................56
Concepts of Alarm Response Delay.............................................................................................................................58
Index.............................................................................................................................................................................................59
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 Stork System.
•Masimo Sensor placement.
•Connecting your Masimo Stork System to WiFi.
Product Description and Intended Use
Product Description
Masimo Stork - a system that provides spot-checking and continuous monitoring of physiological data by
wireless communication to medical technologies. The system includes the following pieces:

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Masimo Stork App - software application installed on a smart phone that provides the graphical user
interface to display your data and alarm condition status.
Masimo Sensor - wireless, wearable sensor that provides the physiological data.
Masimo Chip - attaches to the wireless Masimo Sensor and connects wirelessly to the Masimo Stork
Hub.
Masimo Stork 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 Masimo Stork Hub.
Who the Device is intended to be used on (Indications for Use)
Intended Use
ALL TBD
The Masimo Stork is intended for the spot-checking or continuous monitoring of functional oxygen
saturation (SpO2) and Pulse Rate (PR). The subject device provides the management of notifications and
the ability to display and transfer aggregated data communicated from compatible medical technologies.
Indications for Use
ALL TBD
The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen
saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in adult, pediatric, infants, and neonates
during motion, no-motion and low perfusion conditions in hospital and home environments.
Safety Information
Before using the Masimo Stork, read the following safety information carefully.
Safety Warnings
ALL TBD
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 Masimo Stork Hub where it will not fall on anyone.

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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 Masimo Stork 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
56.
•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 Masimo Stork 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 Masimo Stork 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 Masimo Stork Hub to prevent damage to
the device.
Note: Do not monitor more than one person at a time with Masimo Stork.
Masimo Sensor
ALL TBD
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
ALL TBD
WARNING: Do not self-diagnose or self-medicate on the basis of the measurements. Always consult
your physician.

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WARNING: Do not use Masimo Stork as an apnea monitor. Masimo Stork is not designed to detect
apnea.
WARNING: Only use Masimo-approved parts with Masimo Stork 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 Masimo Stork Hub Liquids spilled on Masimo Stork may
affect how it works.
WARNING: Do not place anything on top of the Masimo Stork 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.).
•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: Check that the Masimo Stork 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 Masimo Stork 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 Masimo Stork Hub to prevent damage to
the device.
CAUTION: Do not connect to an electrical outlet controlled by a wall switch or dimmer.

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CAUTION: When using Masimo Stork, 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 Stork system.
CAUTION: Check your setup by viewing the display on the App and the Masimo Stork Hub. The App and
Masimo Stork Hub will provide an indication if there is a problem with the internet connection.
CAUTION: Check your system setup by viewing the display on the smartphone Masimo Stork
Application. The Masimo Stork App will provide an indication if there is a problem with the internet
connection.
CAUTION: Avoid placing Masimo Stork near other wireless devices to prevent loss of performance.
Masimo Sensor
ALL TBD
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 Masimo Stork
Hub is within the specified distance and in line-of-sight of the Masimo Sensor. See Specifications on
page 43.
Cleaning and Service Warnings
ALL TBD
WARNING: Do not attempt to remanufacture, recondition or recycle the Masimo sensor, Masimo chip or
Masimo Stork Hub to prevent harm or damage to the system.

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WARNING: Always turn off and unplug the Masimo Stork Hub before cleaning to prevent harm or
damage to the device.
CAUTION: Do not clean Masimo sensor, Masimo chip or Masimo Stork 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 Masimo Stork Hub in liquid or attempt to
sterilize by any method to prevent damage to the device.
Compliance Warnings
ALL TBD
WARNING: Changes or modifications not approved by Masimo can void the user’s authority to operate
the equipment.
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 Stork. Using unauthorized devices with
Masimo Stork 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 Stork,
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 Stork 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 Stork.
CAUTION: Keep the Masimo Stork away from electrical equipment that emits radio frequencies to
minimize radio interference. Radio interference may result in no or inaccurate readings.
Note: Masimo Stork 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 Stork generates, uses, and can radiate radio frequency energy and may cause
interference with radio communications. To determine if Masimo Stork 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 Stork.

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•Plug the receiver and Masimo Stork 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.
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 Stork consideration should be taken to local government frequency
allocations and technical parameters to minimize the possibility of interference to/from other wireless
devices.

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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.
The Masimo Stork 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 Stork
•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 Stork.
•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 Stork is placed where it can be heard and the speaker is
not blocked by other objects.

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•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.
Benefits of Masimo Stork
•Masimo Stork 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 Stork 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 Stork uses the same proven pulse oximetry used in hospitals shown to have fewer
false alarms1compared to other brand technology.
•Masimo Stork 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 Stork System
The Masimo Stork system consists of the following:
IMAGE TBD
Item Description
1Masimo Stork Hub
2Smart phone with Masimo Stork App Installed*
3Masimo Sensor
4Masimo Stork Boot
* Smart phone not included.
Features
The following describes the Masimo Stork system parts.

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Masimo Stork Hub Overview
The Masimo Stork Hub is a device that transfers measured data from the wireless Masimo Sensor to the
Masimo Cloud and provides audible and visible alarms.
NEED NEW IMAGE
NEED TO KNOW WHAT INDICATORS THE HUB WILL HAVE
1. Pairing Symbol
Location on the Masimo Stork Hub for pairing the
Masimo Chip.
2. Masimo Stork Hub Button
Used for pairing and silencing alarms.
3. Bluetooth Status LED
Shows the Masimo Stork Hub Bluetooth status. See
Masimo Stork Hub Lights on page 14.
4. Masimo Stork Hub Status LED
Shows the Masimo Stork Hub power and monitoring
status. See Masimo Stork Hub Lights on page 14.
5. Wi-Fi Status LED
Shows the Masimo Stork Hub Wi-Fi status. See
Masimo Stork Hub Lights on page 14.
6. USB Power Connector
Power is provided to the Masimo Stork Hub
from the AC adapter and a USB cable.
7. Masimo Chip Storage Tray
Location on the Masimo Stork Hub for storage
of the chip when not in use.
Masimo Stork Hub Lights
The LED lights on the Masimo Stork Hub show the status of Bluetooth pairing and Wi-Fi connections.

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Indicator/LED
Color
What does it mean?
Masimo Stork Hub Status LED
Solid White Hub is on and needs to be set up.
Solid Green 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 Alerts_O_App.
Solid Orange Level 1 Alert is acknowledged.
Flashing Red Active Level 2 or 3 Alert. See Alarms and Alerts_O_App.
Solid Red Level 2 or 3 Alert is acknowledged.
Flashing Orange Sensor battery ports are blocked.
Flashing Red A Hub fault has been detected.
Bluetooth Status LED
Solid White Hub is on and needs to be set up.
Off Hub is paired with the sensor.
Flashing White Hub is pairing with the sensor.
Solid Orange Sensor is disconnected from the Hub.
Wi-Fi Status LED
Solid White Hub is on and needs to be set up.
Off Hub is connected to the Wi-Fi network.
Flashing White Hub is searching for or connecting to the Wi-Fi network.
Solid Orange Hub is connected to the Wi-Fi and the Sensor is no longer connected.
Masimo Sensor Overview
The Masimo Sensor is for use with the Masimo Stork system.

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1. Masimo Sensor
a. Cable
b. Chip Holder
c. Strap
d. Sensor LED
e. Detector
f. Tape
2. Masimo Chip
a. Light Indicator
ALL TBD NEED SENSOR AND SPECS
Sensor Lights
The light indicator on the Masimo Sensor shows the status of the sensor connection and battery.
Indicator/LED Color What does it mean?
Bluetooth Status
Flashing Blue Sensor is paired with the Hub.
Flashing Green Sensor is not paired with the Hub.
Battery Status
Flashing Orange Sensor battery is low.
Flashing Red Sensor battery is very low.
LED TBD Charging TBD
LED TBD Fully Charged TBD
ALL TBD NEED SENSOR AND SPECS FOR INDICATORS

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Basic Setup and Use
Getting Started
The Masimo Stork system can be ready to use in the following steps:
1. Setup the Smart Phone - Prepare the smart phone for use with the Masimo Stork App.
•Download the Masimo Stork App on your smart phone and complete the registration
and login process.
2. Setup the Masimo Stork System – Use the Masimo Stork App and complete the following:
•Create a profile for the baby (or babies) to be monitored.
•Connect the Masimo Stork Hub to the App using local Wi-Fi.
•Connect the Masimo Sensor with the Masimo Stork Hub.
•Attach the Masimo Stork Boot to the baby.
3. View Live Data – After the Boot with Sensor is attached to the baby, open the Masimo Stork
App to start monitoring and view live data on the Vitals Dashboard.
Step 1: Smart Phone Setup
Prepare the Smart Phone for Use:
A compatible smart phone is required to install and operate the Masimo Stork App.
To use your smart phone with the Masimo Stork App check the following:
•Compatibility
Note: For a list of smart phones and operating systems that work with the Masimo Stork
App, check TBD WWW.??? before upgrading the smart phone or its operating system.
•Smart Phone Battery is charged
•Bluetooth is ON
•Wi-Fi is ON and the smart phone in connected to the internet
•Time is set to the Current Local Time
Download and install the Masimo Stork App on the smart phone:

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Download and install the Masimo Stork App. Follow the on-screen instructions to install.
For more on how to install an app, see the smart phone's manual.
NEED NEW
TBD
Note: If the Masimo Stork App requests for the smart phone to share its location, select OK or Allow.
The smart phone location is required for Bluetooth connection.
Create a User Account:
After installation, open the Masimo Stork App and select Create Account. Follow the on-screen
instructions to create a new user account.
•If you have an existing user account, simply log in using the account credentials.
Step 2: Masimo Stork System Setup
After the Masimo Stork App is installed and user account created, follow the on-screen instructions to set
up your Masimo Stork System:
•Set up a Baby Profile for the baby (or babies) to be monitored.
•Connect the Masimo Stork App to the Masimo Stork Hub and local Wi-Fi network.
•Charge the Masimo Sensor and connect the Sensor to the Masimo Stork Hub.
•Attach the Sensor to the Masimo Stork Boot and attach the Boot to the baby for monitoring.
Create a Baby Profile
After creating an account, login to the Masimo Stork App and follow the on-screen instructions to and set
up a Baby Profile.
1. Enter the requested information about the baby when prompted and select Continue, or
select Skip to not enter that information.
Note: Multiple profiles can be created to monitor different babies.
2. When the Baby Profile is complete, select Set Up HUB to continue.