MASIMO Freedom Health Watch User Manual

MASIMO Freedom Health Watch

About This Manual

This manual explains how to set up and use the Masimo Freedom™. Important safety information relating to the general use of Masimo Freedom appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.

• WARNING : This is an example of a warning statement.
  A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property.

• CAUTION: This is an example of a caution statement.
  A note is given when additional general information is applicable.
  Note: This is an example of a note.

Product Description and Features

Product Description
Masimo Freedom™ is a smartwatch with software and built-in sensors to provide physiological parameter data. When the smartwatch is worn, data is continuously collected and used to provide Oxygen Level (SpO2) and Pulse Rate (PR). The smartwatch also has an on-demand ECG feature that displays a spot- check ECG heart rate. The smartwatch touchscreen displays data and allows for the navigation of the watch features. Masimo Freedom™ watch is equipped with a touchscreen display, rechargeable battery, Bluetooth, Wi-Fi, and optional LTE connectivity.

Safety Information, Warnings, and Cautions

• Safety Warnings and Cautions
  WARNING: Disassembling the battery by yourself will void its warranty and may cause serious harm.

• Performance Warnings and Cautions
  Note: Your Masimo Freedom is equipped with a high-performance non-detachable lithium-ion polymer battery. Observe the maintenance guidelines for a longer battery life.
  Note: Avoid charging in extremely high or low temperatures. The battery performs optimally in an ambient temperature of +5 °C to +35 °C.

Description

This chapter contains a description of the Masimo Freedom’s physical features.
General System Description
The Masimo Freedom system includes the following:

• Masimo Freedom Device
• Masimo Freedom Wireless Charger

For a complete list of compatible accessories, visit www.masimo.com.
Features

Top

1. Power Button
2. Hold for 3 seconds to turn On
3. Hold for 2 seconds to power off.
4. Press once when on watch face to view Main Menu. See Main Menu on page 11.
5. Press once to navigate backwards within the menus and apps.
6. Double press (2x) to return to the watch face.
7. Touch Screen
8. Used to interact with the watch. See Using the Touch Screen on page 10.
9. Tap 2x to open the Main Menu. See Main Menu on page 11.
10. Scroll Wheel
11. Slide up or down on the Scroll Wheel to navigate the Main Menu or within an app.
12. Privacy Switch (Toggle On/Off)
13. Privacy Mode allows you to control the sharing of your personal data so that your data stays private within the watch. See Privacy Mode on page 13 for complete information.

Bbottom

1. Optical Pulse Oximeter Sensor
2. Location of sensors for Vitals measurements.

Basic Setup and Use

This chapter contains information about setting up Masimo Freedom before use.

Charging the Watch

The charge the Masimo Freedom:

1. Plug the charge cable into the AC Adapter, then plug the AC Adapter into a power outlet.
2. Take the Masimo Freedom off your wrist.
3. Place the back of the Masimo Freedom on the magnetic side of the charging cable to begin charging. Look for the “charging screen” to ensure the Masimo Freedom is seated properly on the base.

Turn Watch On or Off
Use the Power Button on the lower left side of the Masimo Freedom To turn the watch On or Off. See Top (on page 7).

Turn Watch On

• With the watch Off, press and hold the Power Button for 3 seconds.

Turn Watch Off

• With the watch On, press and hold the Power Button for 2 seconds to bring up the power off screen. Confirm to power off the watch by touching the icon on the watch face. The watch will power off.
• The watch can also be turned off from the Main Menu. Select Settings > General > Power Off.

Download the Masimo Health App

• The Masimo Health App collects and displays health data from the Masimo Freedom and other paired devices.
• Download the Masimo Health App directly from the Google Play or Apple App Store and follow the setup instructions.
• Masimo Health is required to support software updates to the Masimo Freedom watch. This prevents unauthorized upgrades to the Masimo Freedom

Pair Masimo Freedom to Masimo Health App
Masimo Health app collects and displays vital sign measurements from the watch and other paired devices. To view Masimo Freedom data on the Masimo Health App, perform the following:

1. Set Up the Masimo Health App
   Follow the instructions from the email or text message invitation received to download the Masimo Health App and create an account.

2. Pair the Watch
   On the Masimo Health app, click on the Menu and then choose My Device. Click on Masimo Freedom under the Add Device menu and follow instructions for pairing the watch to the phone.

Putting on the Watch

Place the watch with the screen facing up, on a flat part of the wrist avoiding the wrist bone (A). Tighten the strap so the watch is worn snug against the wrist and does not slide. See Check Watch Status for wristband status.
Note: Make sure the bottom of the watch is fully touching the wrist and cannot slide back and forth.

Using the Touch Screen
When interacting with the watch, use the following gestures to navigate the touch screen.

• Touch/Tap – Momentarily touch and release one finger on the screen.
• Touch and Hold – Touch and hold an item on the screen.
• Swipe – Touch and move one finger on the screen left, right, up or down.

operation

The information in this chapter assumes that Masimo Freedom is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Masimo Freedom without completely reading and understanding these instructions.
User Interface (Display)
Main Menu

The Main Menu displays a list of available apps.

• To open the Main Menu, double-tap the watch face or when viewing the watch face, press the Power Button once. See Top (on page 7).

• Swipe the watch face using one finger or slide up and down on the Scroll Wheel to navigate the Main Menu and view all available Apps.

• Open an app by tapping on its icon on the watch face.

• Press the Power Button to navigate backwards in the apps and watch menus.

• Live – Touch to view live health data measurements.

• Alarm – Access the alarm feature to set and enable/disable alarms.

• Settings – Access additional watch settings. See Watch Settings Options on .

• Timer – Access the timer feature.

• Spot Check ECG – Touch to perform an ECG spot check.

• Phone – Feature to use the phone with a paired smart device.

• Stopwatch – Access the stopwatch feature.

• Watch Face Chooser – Select to change the watch face.

Watch Settings Options
The following settings are available for Masimo Freedom.

display to sleep.
Sound and Vibration| Settings for sounds, vibrations (haptic) and notification sounds and vibrations.
Battery| Battery charge level and power saving mode enable/disable.
General| View items such as information about the Masimo Freedom, perform software updates, or set wrist orientation, among other available items. See

General Settings on page 12.

personal data from Masimo Freedom.

General Settings

• About – Shows Masimo Freedom hardware and software information. Swipe up/down to view the FCC information. Software Update – Identify and install updated software.
  Orientation – Set watch to be worn on the left or right wrist.

• Storage – Displays storage on Masimo Freedom.

• Factory Reset – Resets Masimo Freedom to factory settings.

• Power Off – Turn off Masimo Freedom.

About Watch Screen

• To access the About screen to view the FCC / ISED Regulatory Information:

1. Open the Main Menu.
2. Select Settings.
3. Select General.
4. Select About to view all applicable regulatory information displayed.

Notifications
When a notification is present, a Blue dot appears at the bottom of the watch face. To view and acknowledge the notification, swipe down on the watch face.
Quick Settings
To access the Quick Settings, swipe up from the bottom of the Masimo Freedom watch face. Quick Settings allows access to the following functions and features of Masimo Freedom :

• Bluetooth – Touch to turn On or Off, press and hold to access settings
• Wi-Fi – Touch to turn On or Off, press and hold to access settings
• Airplane Mode – Touch to turn On or Off
• Battery – Press and hold to access settings
• Low Power Mode – Touch to turn On or Off
• Volume – Touch multiple times to change the volume level, and press and hold to access settings
• Vibration – Touch to turn On or Off, press and hold to access settings
• Do Not Disturb – Touch to turn On or Off, press and hold to access settings
• Display Brightness – Press and hold to access settings
• Display Always On – Touch to enable or disable

Privacy Mode

Privacy mode, when activated, disables the hardware interfaces for the following features:

• Bluetooth
• Wi-Fi
• LTE
• NFC
• GPS
• Microphone

To turn Privacy Mode On or Off, use the Privacy Switch on the upper left side of the watch. See Top (on page 7). A notification appears momentarily on the watch face indicating when Privacy Mode has been turned On or Off. An icon appears at the top of the watch face when Privacy Mode is on.

Specifications

Electrical

Battery

Type| Internal Li-ion rechargeable
Output Power| 5V/0.5A
Capacity| Approx. 16 hrs [1]
Charge Time| 2 hrs [2]

Environmental

Environmental Conditions

Operating Temperature| 0°C to 35°C (32°F to 95°F)
Storage/Transport Temperature| -20°C to 60°C (-4°F to 140°F)
Operating Humidity| 10% to 95% RH (non-condensing)
Storage/Transport Humidity| 10% to 95% RH (non-condensing)
Operating Atmospheric Pressure| 540 mBar to 1060 mBar

Physical Characteristics

Physical Characteristics

Watch Size| (L) 50mm x (W) 50mm x (H) 17mm (1.9″ x 1.9″ x .7″)
Weight with Watchband| 60 g (2.1 oz.)
Display Type| ·   AMOLED display with minimum viewing angles of 85°/85°/85°, with a resolution of 454 x 454, and sunlight readable.

·   Capacitive touch screen that is capable to supporting a minimum of 2 point touch.

Expected Service Life| 3 Years

Compliance

Masimo Freedom Safety Standards Compliance

IEC 62368
Protection against harm from solid and liquid ingress| IPX4 – Protection from splashing water, no matter the direction.

Wireless Specifications

Communication (Wi- Fi)

Frequency| 2.4G (2402 MHz – 2472 MHz)

5G (5150 MHz – 5350 MHz, 5490 MHz – 5730 MHz, 5735 MHz – 5835 MHz)

Max Output Power| 20 dBm or 100 mW

Available Data Rates

| 802.11b : Up to 11Mbps 802.11a/g : Up to 54Mbps 802.11n : Up to 150Mbps 802.11ac : Up to 433Mbps
Communication (LTE)

Frequency

| B2 (1850 MHz – 1910 MHz,1930 MHz – 1990 MHz) B4 (1710 MHz – 1755 MHz,2110 MHz – 2155 MHz) B66 (1710 MHz – 1780 MHz,2110 MHz – 2200 MHz) B12 (699 MHz – 716 MHz,729 MHz – 746 MHz)

B13 (777 MHz – 787 MHz,746 MHz – 756 MHz) B17 (704 MHz – 716 MHz,734 MHz– 746 MHz)

Max Output Power| 23 dBm or 199.53 mW
Available Data Rates| Up to 75Mbps
Communication (Bluetooth)

Frequency| 2.4G (2402 MHz – 2480 MHz)
Max Output Power| 13 dBm or 19.95 mW
Communication (nFC)

Frequency| 13.56 MHz
Radio Compliance

USA| Model: Freedom Watch FCC ID: VKF-MASIFDM1 IC: 7362A-MASIFDM1
Model: Masimo Wireless Charger FCC ID: VKF-FDMCRG

IC: 7362A-FDMCRG

Guidance and Manufacturer’s Declaration
Front-of-Face SAR testing has been carried out at a separation distance of 10 mm. When using the watch near your face, keep at least 10mm of separation to ensure exposure levels remain at or below the as-tested levels.
Symbols
The following symbols may be found on the Masimo Freedom, or packaging and are defined below.

Citations

1. This represents approximate run time with 100% charged Device with a minimum of 90% capacity, Display on for 5 seconds for every 10 minutes with brightness setting at 70%, Wi-Fi off, LTE off, nFC off, GPS off, Vibration off, Speaker off, Microphone off, Bluetooth on and transmitting data once every 30 seconds minute, and Masimo Health Module is actively measuring pulse oximetry.
2. The battery shall charge to 80% of battery capacity in no longer than 2 hours at ambient temperature and might not charge completely under elevated ambient temperature.

Service and Maintenance

The following chapter contains information about service, repair, and warranty.
Maintenance
Cleaning the Masimo Freedom and the Charger
CAUTION : Do not immerse Masimo Freedom in any liquid.
The surfaces of Masimo Freedom have been tested to be chemically resistant to the following disinfectants/solutions:

• 70% Isopropyl Alcohol (IPA)
• Clorox® wipes or equivalent

CAUTION : Do not use household cleaning agents. To clean Masimo Freedom, follow the instructions below:

1. Use a soft-bristle, nylon brush wet with deionized water and gently brush along the grooves and crevices of the body to loosen debris before cleaning.
2. Use one Clorox wipe or a 4” x 4” gauze pad saturated with 70% IPA to wipe the surfaces twice or until the surfaces are free of any visible residue.
3. Use a second soft-bristle, nylon brush with thin brush head wet with 70% IPA and gently brush along the grooves and crevices of the body at least twice.
4. Use a second Clorox wipe or a second 4” x 4” gauze pad saturated with 70% IPA to wipe the surfaces twice or until the surfaces are free of any visible residue.
5. When using Clorox wipes, use a 4” x 4” gauze pad saturated with deionized water to wipe the surface once.
6. Allow the Masimo Freedom device to dry thoroughly before using again.

CAUTION: Never saturate Masimo Freedom completely with any disinfection solution.

Service and Return Procedure
Contact Masimo for product support. If needed, an RMA will be provided for repair or replacement. Masimo can be reached at 800-326-4890. For customers outside the United States, local contact information can be found at http://service.masimo.com.
Clean contaminated/dirty equipment before returning per Maintenance and Cleaning instructions. Make sure the equipment is fully dry before packing. Package the device securely, in the original shipping box if possible, and enclose the following information and items:

• Include the RMA form provided, or a letter describing in detail any difficulties experienced with Masimo Freedom. Include the RMA number in the letter.
• Warranty information, a copy of the invoice or other applicable documentation must be included. Purchase Order number to cover repair if the device is not under warranty, or for tracking purposes if it is.
• Ship-to and bill-to information. Person (name, telephone/Telex/fax number and country) to contact for any questions about the repairs.
• A certificate stating that the device has been decontaminated for bloodborne pathogens.
• Return the device to Masimo at the address listed in Contacting Masimo on page 17 below.

Limited Warranty

Masimo warrants to the original end-user purchaser the Masimo-branded hardware product Masimo Freedom and any software media contained in the original packaging against defects in material and workmanship when used in accordance with Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months from the original date the Product was obtained by the end-user purchaser.
Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty.
To request a replacement under warranty, the Purchaser must contact Masimo and obtain a returned goods authorization number so that Masimo can track the Product. If Masimo determines that a Product must be replaced under warranty, it will be replaced and the cost of shipment covered. All other shipping costs must be paid by the purchaser.

Exclusions

• The warranty does not apply to any non-Masimo branded product or any software, even if packaged with the Product, or any Product that was: (a) not new or in its original packaging when supplied to the purchaser; (b) modified without Masimo’s written permission; (c) supplies, devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by anyone other than a person authorized by Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories,not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h) damaged by accident, abuse, misuse, liquid contact, fire, earthquake or other external cause.
• No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized distributor, is not paid; and these Products are provided AS-IS without warranty.

Limitation of Warranty

• Except as otherwise required by law or altered by the purchase agreement, the above warranty is the exclusive warranty that applies to the Product and software media, and Masimo does not make any other promises, conditions, or
• warranties regarding the Product.
• No other warranty applies, express or implied, including without limitation, any implied warranty of merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of reasonable skill and care. See the licensing terms for the terms and conditions that apply to and Software accompanying the Product.
• Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential loss, damage, or expense arising from the use or loss of use of any Products or Software.
• In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by the purchaser for the Product or Software. The above limitations do not preclude any liability that cannot legally be disclaimed by contract.

End-User License Agreement

• This document is a legal agreement between you (“purchaser”) and Masimo Corporation (“Masimo”) for the purchase of this Product (“Product”) and a license in the included or embedded Software (“Software”) except as otherwise
• expressly agreed in a separate contract for the acquisition of this Product, the following terms are the entire agreement between the parties regarding your purchase of this Product
• If you do not agree to the terms of this agreement, promptly return the entire Product, including all accessories, in their original packages, with your sales receipt to Masimo for a full refund.

Restrictions

1. Copyright Restrictions: The Software and the accompanying written materials are copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged, or included with other software, or the written materials is expressly forbidden. Purchaser may be held legally responsible for any copyright infringement that is caused or incurred by Purchaser’s failure to abide by the terms of this Agreement. Nothing in this License provides any rights beyond those provided by 17 U.S.C. §117.
2. Use Restrictions: Purchaser may physically transfer the Product from one location to another provided that the Software is not copied. Purchaser may not electronically transfer the Software from the Product to any other instrument. Purchaser may not disclose, publish, translate, release, distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Software or the written materials.
3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo’s prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void.
4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the Software and documentation are deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement.

FCC STATEMENT

Compliance Warnings and Cautions

• WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment.
• WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.
• WARNING: Please use a 5Vdc/1.5A power Adapter for DC input that meets the safety requirements of regulated power sources.
• CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories.

Note: This device complies with part 15 of the FCC Rules. 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: This device complies with Industry Canada’s license-exempt RSSs. 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: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Note: Do not remove the non-detachable lithium-ion polymer battery battery as this will void the warranty.

FAQ

• Q: What should I do if I encounter a serious incident with the product?
• A: If you encounter any serious incident with the Masimo Freedom Health Watch, please notify the competent authority in your country and the manufacturer immediately.

CONTACT

• Masimo Corporation
• 52 Discovery
• Irvine, California 92618
• Tel:+1 949 297 7000
• Fax:+1 949 297 7001
• www.masimo.com

For Sale in the USA – For Health and Wellness
These operating instructions provide the necessary information for proper operation of all models of the Masimo Freedom. There may be information provided in this manual that is not relevant for your system. Do not operate Masimo Freedom 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:
FCC ID: VKF-MASIFDM1 | IC: 7362A-MASIFDM1 | Model: Freedom Watch FCC ID: VKF- FDMCRG | IC: 7362A-FDMCRG | Model: Masimo Wireless Charger

Patents: www.masimo.com/patents.htm
Masimo®, Masimo SafetyNet®, PVi®, RRp®, SET®, and ® are federally registered trademarks of Masimo Corporation.
Masimo Freedom™ and SET+™ are trademarks of Masimo Corporation.
© 2024 Masimo Corporation

References

• Service masimo
• Masimo - Home
• Region Select

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