Masimo Stork User manual

User's Manual
Masimo Stork™

1
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

3
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

4
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:

5
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.

6
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.

7
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.

8
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.