Masimo W1 Operator's Manual 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 W1. There may be information provided in this manual that is not relevant for your system. Do not operate Masimo W1 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-MASIW1 | IC: 7362A-MASIW1 | Model: W1 Patents: www.masimo.com/patents.htm Masimo, Masimo SafetyNet, SET, RRp, and are federally registered trademarks of Masimo Corporation. Masimo W1 and SET + are trademarks of Masimo Corporation. 2022 Masimo Corporation Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 1-949-297-7000 Fax.: 1-949-297-7001 www.masimo.com Contents About this Manual ---------------------------------------------------------------------------------------------------------------------------------- 4 Product Description and Features ------------------------------------------------------------------------------------------------------------ 5 Product Description ----------------------------------------------------------------------------------------------------------------------------- 5 Safety Information, Warnings and Cautions ----------------------------------------------------------------------------------------------- 5 Compliance Warnings and Cautions ------------------------------------------------------------------------------------------------------- 5 Chapter 1: Description ---------------------------------------------------------------------------------------------------------------------------- 7 General System Description ------------------------------------------------------------------------------------------------------------------ 7 Features ------------------------------------------------------------------------------------------------------------------------------------------- 8 Chapter 2: Basic Setup and Use --------------------------------------------------------------------------------------------------------------- 9 Charging the Watch ----------------------------------------------------------------------------------------------------------------------------- 9 Turn Watch On or Off -------------------------------------------------------------------------------------------------------------------------- 10 Pair Masimo W1 to Masimo Personal Health App ------------------------------------------------------------------------------------- 10 Putting on the Watch -------------------------------------------------------------------------------------------------------------------------- 11 Chapter 3: Operation ------------------------------------------------------------------------------------------------------------------------------ 13 Home Screen ------------------------------------------------------------------------------------------------------------------------------------ 13 Main Menu --------------------------------------------------------------------------------------------------------------------------------------- 14 Chapter 5: Specifications------------------------------------------------------------------------------------------------------------------------ 15 Electrical ------------------------------------------------------------------------------------------------------------------------------------------ 15 Environmental ----------------------------------------------------------------------------------------------------------------------------------- 15 3 www.masimo.com Compliance -------------------------------------------------------------------------------------------------------------------------------------- 16 Wireless Specifications ----------------------------------------------------------------------------------------------------------------------- 16 Symbols ------------------------------------------------------------------------------------------------------------------------------------------ 18 Chapter 4: Service and Maintenance ------------------------------------------------------------------------------------------------------- 21 Maintenance ------------------------------------------------------------------------------------------------------------------------------------ 21 Service and Return Procedure ------------------------------------------------------------------------------------------------------------- 21 Contacting Masimo ---------------------------------------------------------------------------------------------------------------------------- 22 About this Manual This manual explains how to set up and use Masimo W1. Important safety information relating to general use of Masimo W1 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. www.masimo.com 4 Product Description and Features Product Description The Masimo W1 is a watch for use in health and wellness that can be paired to a smart device. Safety Information, Warnings and Cautions 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 users 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. 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 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 www.masimo.com 5 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 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. www.masimo.com 6 Chapter 1: Description This chapter contains the description of the Masimo W1 physical features. General System Description The Masimo W1 system includes the following:
Masimo W1 Device Masimo W1 Wireless Charger For a complete list of compatible accessories, visit www.masimo.com. www.masimo.com 7 Features 1. Menu/Back Button Press and hold to turn the watch On and Off. Press to cycle through menus from Home Screen OR use as a back button when in submenus. 2. Home Button Press once to return to the Watch Face. From the Watch Face, press once to turn off screen. 3. Touch Screen Tap or swipe to interact with the watch. www.masimo.com 8 Chapter 2: Basic Setup and Use This chapter contains information about setting up Masimo W1 before use. Charging the Watch The charge the Masimo W1:
1. Plug the charging cable into a power outlet. Take the watch off your wrist. 2. 3. Place the back of your watch on the magnetic side of the charging cable to begin charging. www.masimo.com 9 Turn Watch On or Off Turn Watch On Turn Watch Off With the watch Off, press and hold the Menu/Back Button until the watch turns On. With the watch On, press and hold the Menu/Back Button until the watch turns Off. Pair Masimo W1 to Masimo Personal Health App Masimo Personal Health app collects and displays vital sign measurements from the watch and other paired devices. With the app you can access care plan instructions from your care provider. Entered symptoms and collected measurements will be sent to your care provider. To view Masimo W1 data on the Masimo Personal Health App, perform the following:
1 Set Up the Masimo Personal Health App Follow the instructions from the email or text message invitation received to download the Masimo Personal Health App and create an account. 2 Pair the Watch On the Masimo Personal Health app, click on the Menu and then choose My Device. Click on Masimo W1 under the Add Device menu and follow instructions for pairing the watch to the phone. www.masimo.com 10 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 such that the watch is worn snug against the wrist. See Check Watch Status for writsband status. Note: Make sure the bottom of the watch is fully touching the wrist and not sliding. www.masimo.com 11 Chapter 3: Operation The information in this chapter assumes that Masimo W1 is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Masimo W1 without completely reading and understanding these instructions. The Home Screen displays Date, Time, *SpO2, *Pulse Rate and Daily Step Count.
* Displays when monitoring is enabled under the Main Menu. Home Screen www.masimo.com 13 Main Menu The Main Menu displays a list of available functions. Access by pressing the top button Swipe left or right using one finger to navigate the menu. Open a function by tapping on its icon. Measurement Settings - Select option and start measurements Step Settings - Enable/Disable tracking Watch Face Settings - Change watch face Watch Brightness Settings - Change brightness and duration Settings Menu - Additional watch settings.
(Vibration/Bedtime) About Watch - Display information about the watch, such as software version, regulatory marks, etc www.masimo.com 14 Chapter 5: Specifications Electrical Battery Type Internal Li-ion rechargable Capacity Approx. 10 hrs Charge Time 3 hrs*
* Time to reach 80% charge capacity. Environmental Environmental Conditions Operating Temperature 0C to 35C (32F to 95F) Storage/Transport Temperature
-20C to 60C (-4F to 140F) 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 Water Resistance Up to 50 Meters for 10 minutes www.masimo.com 15 Compliance Masimo W1 Compliance FCC Part 15, Subpart C, Section 15.247 FCC Part 2.1093 Masimo W1 Charger Compliance FCC Part 15 Subpart C, Section 15.207 and 15.209 FCC Part 2 Section 2.1049 FCC Part 2.1091 Wireless Specifications Communication (Bluetooth) Type BLE Frequency 2402-2480 MHz Max Peak Output Power
-3.6dBm or 0.44mW Antenna Peak Gain
+3dBi www.masimo.com 16 Radio Compliance Radio Modes Bluetooth LE USA Model: W1 FCC ID: VKF-MASIW1 Model: Masimo Wireless Charger FCC ID: VKF-MASIW1CG Canada Model: W1 IC: 7362A-MASIW1 Model: Masimo Wireless Charger IC: 7362A-MASIW1CG www.masimo.com 17 The following symbols may be found on the Masimo W1, or packaging and are defined below. Symbols Definition Symbols Definition Follow Instructions for use Consult instructions for use Catalog number (model number) Serial number Lot Code Atmospheric pressure limitation Manufacturer Date of Manufacture YYYY-MM-DD Symbols www.masimo.com 18 Symbols Definition Symbols Definition Storage humidity limitation Storage temperature range Federal Communications Commission (FCC) licensing Separate collection for electrical and electronic equipment (WEEE) Identifies unit has been registered as a radio device Protection from dripping water when tilted up to 15. Bluetooth
Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available in all countries. www.masimo.com 19 Chapter 4: Service and Maintenance The following chapter contains information about service, repair, and warranty. Maintenance 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 W1. 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 22 below. www.masimo.com 21 Contacting Masimo Masimo Corporation 52 Discovery Irvine, California 92618 Tel:+1 949 297 7000 Fax:+1 949 297 7001 Limited Warranty Masimo warrants to the original end-user purchaser the Masimo-branded hardware product Masimo W1 and any software media contained in the original packaging against defects in material and workmanship when used in accordance with Masimos 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. Masimos 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, 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 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 purchaser; (b) modified without Masimos 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 www.masimo.com 22 or maintained as provided in the operators 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 Masimos liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by 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. www.masimo.com 23 Restrictions 1. 2. 3. 4. 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 Purchasers 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. 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. 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 Purchasers 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. 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. www.masimo.com 24 www.masimo.com SUB-1477A-0622