Masimo W1 Operator's Manual

Not for Sale in the USA - For Export Only
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.
See instructions for use for information, including indications, contraindications, warnings, and precautions.
Wireless Radio:
Contains: FCC ID: VKF-MASIW1 | IC: 7362A-MASIW1 | Model: W1
Contains: FCC ID: VKF-MASIW1CG | IC: 7362A-MASIW1CG | Model: Masimo Wireless Charger
Manufacturer Manufacturer
Masimo Corporation
52 Discovery, Irvine, CA 92618, USA 52 Discovery, Irvine, CA 92618, USA
Tel.: 1-949-297-7000
Fax.: 1-949-297-7001
www.masimo.com
Patents: www.masimo.com/patents
Product Description, Features and Indications for Use
The Masimo W1® is a watch that provides spot-check ECG measurements and continuous
measurements of functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR),
and respiration rate from the pleth (RRp®). The watch has a touchscreen display, a
rechargeable battery, and Bluetooth® connectivity to pair to a smartphone app.
Key features of Masimo W1 include:
• Masimo SET+™ technology.
• Electrocardiogram (ECG) technology.
• Bluetooth® LE for the wireless communication.
Intended Use
Masimo W1® is intended to be worn on the wrist for the spot-checking of ECG and other
continuous parameters (e.g., pulse oximetry). The watch is intended to be used in hospital,
hospital-type facilities, long-term care facilities, and home.
Indications for Use
Masimo W1® watch and the integrated Masimo W1 Module are indicated for patients with
suspected heart conditions and health-conscious individuals.
The Masimo W1® watch and the integrated Masimo W1 Module are indicated for the
detection, display, recording, and transferring of a single lead ECG and determination of
ECG parameters (e.g., Heart Rate, Atrial Fibrillation) on adults.
The Masimo W1® watch and the integrated Masimo W1 Module are indicated for
non-invasive spot-checking of functional oxygen saturation of arterial hemoglobin (SpO₂),
pulse rate (PR), and respiration rate from the pleth (RRp) on adults.
Description
The Masimo W1 includes the following:
• Masimo W1 Watch
• Masimo W1 Wireless Charger
1 Main Menu/Back Button*
• Press and hold to turn the watch Off. When Off, press once to turn the watch On.
• From the watch face, press once to view the Main Menu OR to navigate backwards
when viewing setting menus and other screens.
2 Live Screen Button*
• From the watch face, press once to view the live health data screen. Screen returns
to the watch face after a few moments of inactivity.
• From the watch face, press two times to turn off the screen.
• Press once to return to the watch face when viewing setting menus and other
screens.
3 Touch Screen
• Used to interact with the watch. See Using the Touch Screen section.
TOP
4 ECG Electrode
• ECG electrodes provided on the top and bottom bezels to be contacted with the
* Press and hold both buttons
to reboot the watch fi ngers during ECG measurements.
Basic Setup and Use
The following steps are for the basic setup and use for operating the Masimo W1.
Charge the Watch
Before using Masimo W1, fully charge the battery.
1. Plug the charging cable into a USB-A power source.
2. Place the bottom of the Masimo W1 on the charging cable
base so that it is seated fl ush to begin charging. Note: The
Masimo W1 may need to be connected to other side of the
base if it does not sit fl ush.
3. Look for the "charging screen" to ensure the Masimo W1 is
seated properly on the base. Note: Use only a Masimo
authorized charger when charging Masimo W1.
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.
Download the Masimo Health or Masimo SafetyNet App
The Masimo App collects and displays health data from the Masimo W1 and other paired devices. The
App is available directly from the Google Play or Apple App Store. The Masimo SafetyNet app or the
Masimo Health app are required to support software updates to the Masimo W1 watch. This prevents
unauthorized upgrades to the Masimo W1.
• Patients using telehealth services should download and install the Masimo SafetyNet App.
• Consumers should download and install the Masimo Health App.
Pair Masimo W1 to the Masimo App
Pair Masimo W1 to the mobile device to view data from the
watch on the Masimo App.
Note: Masimo SafetyNet App is shown in the example.
To pair the watch to the Masimo SafetyNet App, from the My
Devices screen on the App, choose "+" to add a device.
To pair the watch to the Masimo Health App, from the Devices
screen on the App, choose Add Device.
Click on Masimo W1 under the Add a Device or Select a Device screen
and follow the instructions for pairing the watch to the mobile device.
Note: The connection needs to be confi rmed to complete the pairing process.
Put on the Watch
1. Place the watch with the screen facing up, on a fl at part of
the wrist avoiding the wrist bone (A). The buttons should be
towards your hand.
2. Tighten the strap so the watch does not slip and then
tighten the watch 1 to 2 more notches so that it does not
slide but is comfortable.
Note: The watch has an indicator if the wrist M-band is too loose.
See Watch Status Screen for wrist M-band status.
Note: Make sure the bottom of the watch is fully touching the
wrist and does not slide back and forth.
Note: Remove the watch before swimming, bathing or similar
activities.
Using the Touch Screen
When interacting with the watch, use the following gestures to navigate the touch screen.
Touch/Tap Touch and Hold
Momentarily touch and release Touch and hold an item
one fi nger on the screen. on the screen.
M A S I M O W 1
Masimo®, Masimo W1®, Masimo SafetyNet®, SET®, RRp®, and
registered trademarks of Masimo Corporation. M-band™ and SET+™ are trademarks of
Masimo Corporation. Google Play and the Google Play logo are trademarks of Google LLC.
App Store and App Store logo are registered trademarks of Apple Inc. The Bluetooth® word
mark and logo are registered trademarks owned by Bluetooth SIG, Inc.
© 2024 Masimo Corporation
For a complete list of compatible accessories,
visit www.masimo.com.
Swipe
Touch and move one fi nger on the
screen left, right, up or down.
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.
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.

® are federally A note is given when additional general information is applicable. Note: This is an example of a note.
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
The Masimo W1® provides these measurement features:
Heart Rate (HR)
Heart Rate Variability (HRV)
Functional Oxygen Saturation of
Arterial Hemoglobin (SpO₂)
Pulse Rate (PR)
Respiration Rate from Pleth (RRp)
Atrial Fibrillation (AFib)
Sinus Rhythm
Perfusion (Pi)
Pleth Variability Index (PVi)
Pule Rate Variability (PRV)
Turn On Health Data
The continuous health data can be turned on by selecting the Vitals icon and following the steps below. The
Vitals icon can be found from either the Main Menu or the Watch Status screen. See Main Menu or Watch
Status Screen section.
9:46 1. Select the Vitals Measurement icon to turn on the Continuous Health Data.
2. Check that the bottom of the watch makes good contact with the top of your wrist.
3. Check that the watch is secured comfortably to prevent it from slipping (1 or 2 notches tighter after it no
24%
longer slides on the wrist).
To view the Live Health Data (Vitals)
screen, swipe left or right across the
watch face using one fi nger until the
screen displays OR press the lower
button on the side of the Masimo W1.
Swipe up and down (1) using one
fi nger to navigate the Live Health
Data screen and view all available
health data.
See Live Health Data (Vitals) Screen section for complete information about the Live Health Data (Vitals) screen.
Take an ECG Heart Rate Measurement
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 section. Ensure the Masimo W1
is on the wrist identifi ed in the Orientation settings to ensure a proper ECG measurement.
See Watch Settings Options and Information section.
Access the ECG measurement screen by touching the ECG icon from the Main Menu.
1.
2. Check that the electrode pad on the bottom of the watch makes good contact to the wrist.
3. Place your thumb on the electrode pad on the lower bezel (below the lower portion of the watch screen) and
index fi nger on the upper bezel (above the upper portion of the watch screen) until the results screen is displayed.
Note: Do not move during the ECG measurement. The measurement will take approximately 30 seconds.
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 and checks the ECG rhythm for
signs of atrial fi brillation (a common form of arrhythmia) for heart rates of 50 to 150 bpm.
CAUTION:
Masimo W1 does not display a screen message (classifi cation) if the measurement is outside
of the operational range.
The following are explanations of the messages for the ECG measurement:
Screen Message Explanation
Medical term for normal heart rhythm. This refers to the normal electrical activity of your heart when blood is pumping effi ciently
Normal Sinus
between the upper and lower chambers and throughout your body.
Rhythm applies to the duration of the spot-check measurement and does not fully exclude cardiac arrhythmias. If you're not feeling well, you
should follow up with your healthcare provider.
Medical term for a type of abnormal heart rhythm. A common abnormal heart rhythm beginning in the upper chambers of your
Atrial Fibrillation heart resulting in an irregular pulse rate that is sometimes very fast with poor movement of blood into the lower chambers of your
(AFib) heart. Note: If you have not been previously diagnosed with atrial fi brillation and consistently receive this result, or if you're not
feeling well, you should consult with your healthcare provider.
A low heart rate ECG classifi cation will indicate a heart rate below 50 bpm, which can be commonly due to benign causes such as
certain medication effects and is considered a normal fi nding during rest among well-conditioned athletes or other cardiovascular
Low Heart Rate
fi t individuals.
can sometimes indicate an underlying cardiovascular condition.
A high heart rate ECG classifi cation will indicate heart rate greater than 100 bpm, which can be due to exercise, stress, the presence
High Heart Rate of cardiac arrhythmia, or consumption of alcohol, stimulants, or caffeinated drinks.
should follow up with your healthcare provider.
This is not a classifi cation of the ECG. This message means that the ECG recording could not be classifi ed, which may be due to a
number of reasons such as other types of arrhythmias, pacing, or heart conditions that Masimo W1 is not designed to detect. It is
Inconclusive recommended to repeat the measurement in a few minutes if you get this result. An inconclusive reading does not indicate the
presence or absence of any arrhythmias (Including AFib) or other heart conditions.
Note: If you consistently receive this result, you should follow up with your healthcare provider, particularly if you're feeling unwell.
This in not a classifi cation of the ECG. The message means the ECG waveform quality and performance were compromised and the
Noise device cannot report any measurements from the ECG. See Troubleshooting section for possible reasons and how to get the best
results from Masimo W1 ECG.
®
Estimation of the number of heart beats per minute (BPM) based on the electrical signals detected in the ECG waveform. The
electrical signal refl ects the changes in polarization of the heart muscles during expansion and contraction or heartbeat.
Variations in the amount of time between heart beats, which may provide insight in how consistently you are reacting to changes
that affect your heart rate like exercise or stress.
Estimation of relative amount of oxygen available in the blood fl owing to the tissues. The estimation is made by using the ratio of
the amount of light absorbed by oxygenated hemoglobin and deoxygenated hemoglobin by different wavelengths of light.
Feature that refl ects how often blood is being pushed through the body by the heart or pulse. Estimation of the number of times
blood is pushed through the body by the heart per minute. The estimation is made from the pulsatile light absorption changes
used for determining SpO₂.
Estimation of the number of times the lungs expand and contract per minute. The estimation is made based on cyclic variations in
the photoplethysmogram (i.e., pleth or PPG).
An irregular heartbeat classifi cation made on the ECG waveform. The classifi cation is made based on the detection of electrical
signals in the two upper chambers of the atria fi ring rapidly at the same time causing the heartbeat to get out of sync and faster.
A normal heartbeat classifi cation made on the ECG waveform. The classifi cation is made based on the detection of normal heart
rhythms where the electrical pulse travels through the heart muscle correctly from the sinus node.
Calculation of the relative strength of the pulsatile signal used for the SpO₂ and Pulse Rate. The Pi increases with better blood
circulation. Your SpO₂ values may be more reliable when your Pi value is higher. Pi values 0.25 or below are typically considered
low. If your Pi is low, try warming your hands or using a different fi nger.
Calculation of the dynamic changes in the Perfusion Index (Pi) that occur during a respiratory cycle. The calculation is
accomplished by measuring changes in Pi over a time interval where one or more complete respiratory cycles have occurred.
Calculation of the variation of the amount of time between pulses monitored during the pulse rate estimation. The calculation is
made by analyzing the pulse rate and determining the difference in the amount of time between pulses in milliseconds (ms).
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.
3 Wrist M-band Release Button
• Press inward to remove the wrist M-band (watchband). Serial
number and compliance information are located in the recesses
behind the wrist M-band.
BOTTOM
WARNING: If you're not feeling well, you should follow up with your healthcare provider as very low heart rates
O P E R A T O R ' S M A N U A L
WARNING: It is important to remember that this only
WARNING: If you're not feeling well, you