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Summary of Contents for Masimo W1
- Page 1 User's Guide Masimo W1 ® Medical Smartwatch...
- Page 3 For Sale in the USA 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 Masimo W1. 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.
- Page 5 About This Manual This manual explains how to set up and use the 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.
- Page 6 Masimo W1® and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides the spot-checking of other continuous parameters (e.g., pulse oximetry).
- Page 7 Your Body and Oxygen When we breathe, oxygen moves in our blood around our body. Pulse oximeters like the Masimo W1 help to identify the oxygen level in the blood. A normal resting SpO levels are typically 95% or greater. However, normal values can be lower for individuals with lung disease, advanced age, or those living at high altitude. A SpO below 90% is typically considered low and outside the normal range, but it is important to not self-diagnosis.
- Page 8 Masimo W1 Risks and Benefits Use of Pulse Oximeters and their Limitations Pulse oximeters provide blood oxygen, SpO , based on how light shines through tissue. The accuracy of your SpO depends on how well the light is passed through the tissue.
- Page 9 Masimo W1. CAUTION: To establish and maintain the minimum Quality of Service of the Masimo W1, keep the Masimo W1 within ~7 m (~23 ft.) line of sight to the mobile device App.
- Page 10 CAUTION: Cloud based features of Masimo W1 supported apps rely on an internet connection with your mobile device. To ensure connection to the cloud, check your mobile device internet is connected. The data from your Masimo W1 may not go to the cloud if there is no internet connection. Restore internet connection within 24 hours to prevent loss of data.
- Page 11 Cleaning and Service WARNING: Clean the Masimo W1 only with the solutions listed in this manual. Do not attempt to clean, sanitize, or sterilize the Masimo W1 using heat, steam, boiling or similar means. Doing otherwise could cause damage that affects the performance of your Masimo W1.
- Page 12 Masimo W1 Safety Information Note: When using Masimo W1 consideration should be taken to local government frequency allocations and technical parameters to minimize the possibility of interference to/from other wireless devices. 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.
- Page 13 • ECG electrodes provided on the top and bottom bezels to be contacted with the fingers during ECG measurements. Bottom 1 Bottom ECG Electrode • ECG electrode on the bottom of the Masimo W1 that makes contact with the wrist. 2 Optical Pulse Oximeter Sensor • Location of sensors for Vitals measurements.
- Page 14 Turn the Watch On To turn the Masimo W1 on, press and hold the top button until the watch turns On. To turn off, press and hold the top button again until the watch turns Off. Put on the Watch Place the watch with the screen facing up, on a flat part of the wrist avoiding the wrist bone (A).
- Page 15 To view the Live Health Data screen, swipe right across the watch face using one finger or press the lower button on the side of the Masimo W1. Swipe up and down (1) using one finger to navigate the Live Health Data screen and view all available health data.
- Page 16 The ECG Heart Rate Measurement can be accessed by touching the ECG icon from the Main Menu and following the steps below. See Main Menu on page 17. Ensure the Masimo W1 is on the wrist identified in the Orientation settings to ensure a proper ECG measurement. See Changing Settings Options on page 17.
- Page 17 Basic Setup and Use Understanding the ECG Results Screen ECG is the electrical activity within the heart that controls the heartbeat. The Masimo W1 can record a single lead ECG, similar to lead I. The Masimo W1 measures heart rate.
- Page 18 • Ensure the Masimo W1 has the latest updates. See Updating the Masimo W1 Software on page 18. Masimo will continue to provide product support including but not limited to cybersecurity management or support such as providing security updates, until 3 years (indented lifetime of device) after the last manufactured devices is placed on the market.
- Page 19 Date Orientation By default, the Masimo W1 is set to be worn on the left wrist. To set the watch to be worn on the right wrist, selection Right from the options available on the Orientation screen. Note: Orientation setting can affect the Raise to Wake feature operation.
- Page 20 Correct Change Watch Face To change the Masimo W1 face, open the Main Menu. See Main Menu on page 17. Touch the Watch Face Icon. Swipe left or right on watch face with one finger to choose a new watch face.
- Page 21 • Ensure Masimo W1 is worn properly on the wrist. See Put on the Watch on page 12. properly. • Ensure the finger makes good contact with the bottom side of the bezel of the Masimo W1. See Take an ECG Heart Rate Measurement on page 14.
- Page 22 ≤ 1 uV The Masimo W1 includes LEDs that emit wavelengths in range of 500 nm to 1000 nm with a peak optical power less than 20 mW. This information about the wavelength range may be more useful for your healthcare professional.
- Page 23 Masimo W1 Appendix The below Bland-Altman plot helps to see the difference in the Masimo W1 SpO and the blood reference (SaO ) or SpO - SaO under no motion conditions at different blood reference values (SaO ). The dotted lines mark the LoA or the upper 95% and lower 95% limits of agreement. If the difference (SpO...
- Page 24 Protection against harm from solid and liquid ingress IP24, Protected from objects greater than 12 millimeters and water spray from any direction. Mode of Operation Continuous Sterility No part of Masimo W1 is supplied sterile Radio Compliance USA Model: W1 FCC ID: VKF-MASIW1...
- Page 25 The ME Equipment is intended for use in the Professional and Home Healthcare Environments. The customer or the user of ME Equipment should ensure that it is used in such an environment. The essential performance of the Masimo W1 was measured based upon the deviations in the simulated baseline measurements for the SpO , PR, and ECG HR parameters.
- Page 26 3 Vrms 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the Masimo W1, including IEC 61000-4-6 cables, than the recommendation separation distance calculated from the equation applicable to the frequency of the...
- Page 27 Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Symbols The following symbols may be found on the Masimo W1, or packaging and are defined below. Symbols...
- Page 28 Cleaning and Service of the Masimo W1 CAUTION: Do not immerse Masimo W1 in any liquid. The surfaces of Masimo W1 have been tested to be chemically resistant to the following disinfectants/solutions: • 70% Isopropyl Alcohol • CaviWipes™...
- Page 29 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 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;...
- Page 30 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...
- Page 32 304957/LAB-12208A-1024...
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