Masimo W1 Manual

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.

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.

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, Features and Indications for Use

Product Description
The Masimo W1™ is a watch that provides spot-check ECG measurements and continuous measurements of functional oxygen saturation of arterial hemoglobin (SpO 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

Features
Key features of Masimo W1 include:

• Masimo SET+™ technology.
• Electrocardiogram (ECG) technology.
• Bluetooth® LE for the wireless communication.

The Masimo W1™ provides these measurement features:

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 (SpO pulse rate (PR), and respiration rate from the pleth (RRp) on adults.

Description

This chapter contains the description of the Masimo W1 physical features.

General Description
The Masimo W1 includes the following:

• Masimo W1 Watch
• Masimo W1 Wireless Charger

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

Features
Top

1. Main Menu/Back Button
   • Press and hold to turn the watch On or Off.
   • Press to cycle through menus from Home Screen OR use as a back button when in submenus.
2. Live Screen Button
   • Press once to view health data (live screen). Screen returns to watch face after a few moments of inactivity.
   • From the Watch Face, press once to turn off screen.
3. Touch Screen
   • Used to interact with the watch. See Using the Touch Screen.
4. Top ECG Electrode
   • ECG electrode provided on the bottom bezel to be contacted with the finger 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.
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.

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 seated flush to begin charging.
   Note: The Masimo W1 may need to be connected to other side of the base if it does not sit flush.

3. Look for the "charging screen" to ensure the Masimo W1 is seated properly on the base.

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 Personal 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. Masimo Personal Health or Masimo SafetyNet are required to support software updates to the Masimo W1 watch. This prevents unauthorized upgrades to the Masimo W1.

• Consumers should download and install the Masimo Personal Health App
• Patients using telehealth services should download and install the Masimo SafetyNet App.

Pair Masimo W1 to Masimo App
Pair Masimo W1 to the mobile device to view data from the watch on the Masimo App.

Note: Masimo Personal Health App is shown in the example.
To pair the watch to the Masimo Personal Health App, from the Devices screen on the App, choose Add Device.
To pair the watch to the Masimo SafetyNet App, from the My Devices screen on the App, choose "+" to add a device.
Click on Masimo W1 under the Select a Device screen and follow the instructions for pairing the watch to the mobile device.
Note: The connection needs to be confirmed to complete the pairing process.

Put on the Watch

1. Place the watch with the screen facing up, on a flat 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 - 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.

	Vitals Measurement * - Feature to start or stop health data measurements. See Activate Continuous Health Data.		ECG Measurement - Feature to perform an ECG spot check. See Take an ECG Heart Rate Measurement.		Watch Face Settings - Feature to change watch face. See Change Watch Face.
	Settings Menu - Access additional watch settings. See Changing Settings Options.		Watch Information - Displays software and regulatory information about watch. Serial number and compliance information are also located behind recess for the wrist M-band.

* The Vitals icon background color changes when active.

Watch Status Screen

To view the Watch Status screen, swipe downward on the watch face with one finger, or press the bottom button on the watch. Touch an icon to view status or access settings.

	Battery Level	Battery level in percentage displays on the Watch Status screen. When battery charge is low, a notification displays.
	Bluetooth Status
	Vibration Mode	Touch the icon to display the Vibration screen. This feature can be turned on or off from the Vibration screen.
	Bedtime Setting	Touch the icon to display the Bedtime screen and change the settings. See Changing Settings Options for complete information.
	Health Data	Touch the icon to display the Vitals screen. Vitals can be started and stopped from this screen. See Activate Continuous Health Data.
	Wrist M-band Tightness

Change Watch Face
To change the Masimo W1 face, open the Main Menu. See Main Menu.

1. Touch the Watch Face Icon.
2. Swipe left or right on watch face with one finger to choose a new watch face.
3. When the desired watch face displays - stop swiping, this is now the watch face.

Live Health Data (Vitals) Screen
The Live Health Data (Vitals) screen contains the following information:

1. Health Data (Vitals)
   When Vitals are enabled, Health Data displays. If Vitals are not enabled, the options to Start Vitals displays. See Activate Continuous Health Data.
2. Waveform and Signal Quality Indicators
   See Waveform and Signal Quality Indicators for information.
3. Daily Step and Calorie Count
   Shows how many steps have been taken and calories burned on this date. This count resets daily.

Changing Settings Options
The following setting are available through the Main Menu.

Troubleshooting

Below are some possible issues and recommended solutions for Masimo W1.

The following messages may appear on Masimo W1.

Specifications

Display Range and Resolution

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.

Pulse-Oximetry Performance

* A RMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A RMS of the reference measurements in a controlled study.

Oxygen Level (SpO₂) ARMS Performance Specifications
The table below provides A RMS (Accuracy Root Mean Square) values measured using the Masimo W1 under no motion in a clinical study.

ECG Performance

Physical Characteristics

Electrical

Environmental

Wireless Specifications

Symbols
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
	Date of Manufacture YYYY-MM-DD		Manufacturer
	Battery		No parameter alarms
	Catalog number (model number)		Serial number
	Lot Code		Storage temperature range
	Atmospheric pressure limitation		Storage humidity limitation
	Bluetooth

Citations
[1] SpO 2 performance has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% against a laboratory co-oximeter.
[2] SpO 2 performance has been validated under low perfusion (≤ 0.3 perfusion index) accuracy in human blood studies on healthy adult male and female volunteers with light to dark pigmented skin in induced hypoxia studies in the range of 70%-100% against a laboratory co-oximeter.
[3] RRp performance has been validated for no motion accuracy on healthy male and female volunteers against manual clinician-scored capnograms. RRp performance was validated across the entire range of 4 to 70 RPM through bench testing.
[4] This represents approximate run time with Screen on-time: 0%, Bluetooth connection On, Active Measurement, SpO 2 and Heart Rate (Continuous Vitals On), ECG (10 Spot-Check measurements), using a fully charged battery.
[5] The battery shall charge to 80% of battery capacity in no longer than 3 hours at ambient temperature and might not charge completely under elevated ambient temperature.
[6] If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20°C to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened.

Service and Maintenance

The following chapter contains information about cleaning, service, repair, and warranty.

Cleaning Masimo W1 and Charger

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™

To clean Masimo W1, follow the instructions below:

1. Use a soft-bristle, nylon brush wet with DI water and gently brush along the grooves and crevices of the body to loosen debris before cleaning.
2. Use one CaviWipe 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 CaviWipe 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 CaviWipes, use a 4" x 4" gauze pad saturated with DI water to wipe the surface once.
6. Allow the Masimo W1 device to dry thoroughly before using again.

Never saturate Masimo W1 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 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 below.

Contacting Masimo
Masimo Corporation
52 Discovery Irvine, California 92618
Tel:+1 949 297 7000
Fax:+1 949 297 7001

Safety Information, Warnings and Cautions

Read the manual, all precautionary information, and specifications before use.
Failure to follow these instructions may increase the potential residual risk of the following:

• Possible wrong or delayed treatment decision due to overreliance.
• Electrical, Fire, or Mechanical Injury.
• Skin irritation due to potential allergic reaction.

Safety Warnings and Cautions

Do not use the Masimo W1 if it appears or is suspected to be damaged. Damage to the device can result in exposed sharp edges that may cause harm.

Do not adjust, repair, open, disassemble, or modify the Masimo W1. Damage to the device may result in degraded performance and/or injury.

Do not use in areas filled with flammable gases: such as anesthetics, oxygen, oxygen-enriched environments, or nitrous oxide to prevent risk of fire.

Keep Masimo W1 away from small children. Small items may become a choking hazard.

Do not touch if defibrillation is required to prevent damage to the device.

Do not use Masimo W1 during magnetic resonance imaging (MRI) or in an MRI environment.

• The device contains materials that can be attracted by the MR magnet core that can make it a risk of projectile injury.
• Metal components can heat up during MR scanning that can present thermal injury and burns.
• Artifacts can be created in the MR image.
• Strong magnetic fields may prevent the device from operating properly.

Note: Do not use on more than a single patient at a time with the Masimo W1.
Note: Use and store as directed in the Specifications section in this manual.

Performance Warnings and Cautions

Masimo W1 should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms.

Masimo W1 is not intended to be used as an apnea monitor. Do not rely on the Masimo W1 for detection of cessation of breathing.

If any measurement seems questionable, first check the patient's vital signs by alternate means and then check that the Masimo W1 is functioning properly.

Masimo W1 does not have alarms to support continuous monitoring.

Masimo W1 may be used during defibrillation; however, the display may require up to 5 seconds to return to normal operation.

Masimo W1 is not intended for use during electrocautery.

Masimo W1 may not fully charge in a high ambient temperature environment.

Displayed parameter(s) may not be accurate when the SIQ is low. Additional information to supplement values should be used to completely understand the patient's condition.

Check the watchband periodically to ensure adequate securement, circulation, and skin integrity. Watchbands applied too tightly or that become tight due to edema can cause inaccurate readings and/or pressure injury.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Masimo W1. Otherwise, degradation of the performance of this equipment could result.

When using with a smart device, keep both devices within the recommended range of each other. See Specifications for details. Moving outside of this range may cause a loss in connection.

The RRp value may be inaccurate under conditions where the pulse rate is less than two times the respiration rate. The following conditions may include, but it's not limited to patients with high respiration rate and low heart rate, or patients with specific medical conditions such as sick sinus syndrome, bradycardia due to any primary cardiac conditions as well as secondary condition from beta blockers, digoxin, etc.

Respiration rate provides an indicator of central ventilatory drive and not a direct indication that air is moving through the upper airway.

If using Masimo W1 during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate, or the device might read zero for the duration of the active irradiation period.

When patients are undergoing photodynamic therapy, they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy.

High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance.

Do not place the Masimo W1 near electrical equipment that may affect the device, preventing it from working properly.

Failure to charge Masimo W1 promptly after a Low Battery alarm may result in the device shutting down.

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 smart device App.

The wireless quality of services may be influenced by the presence of other devices that may create radio frequency interference (RFI). Some RFI devices to consider are as follows: electrocautery equipment, diathermy, cellular telephones, wireless PC and tablets, pagers, RFID, MRI, electrically powered wheelchair, etc. When used in the presence of potential RFI devices, consideration should be taken to maximize separation distances and to observe for any potential signs of interference such as loss of communication or reduced Wi-Fi signal strength.
Note: Always charge Masimo W1 when it is not in use to ensure that the Masimo W1 battery is fully charged before use.
Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will vary depending upon the age of the battery.
Note: A functional tester cannot be used to assess the accuracy of the Masimo W1.

Pulse Oximetry Performance

If SpO ₂ values indicate hypoxemia, do not self-diagnose. Confirmation by a medical professional is required.

SpO ₂ is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).

Optical, pleth-based measurements (e.g., SpO ₂ , PR, and RRp) can be affected by the following:

• Incorrect watch placement or securement (e.g., too loose, too tight).
• Blood pressure cuff inflated or constricting the same arm.
• Intravascular dyes such as indocyanine green or methylene blue.
• Arterial catheter
• Venous congestion
• Abnormal venous pulsations (e.g., tricuspid value regurgitation, Trendelenburg position).
• Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g., cardiac arrhythmias, intra-aortic balloon, etc.).
• Moisture, birthmarks, skin discoloration, tattoos, henna, or foreign objects in the light path.
• Elevated levels of bilirubin
• Physiological conditions that can significantly shift the oxygen disassociation curve.
• A physiological condition that may affect vasomotor tone or changes in vasomotor tone.
• Loss of pulsatile signal

No or inaccurate SpO 2 readings may additionally be caused by:

• Elevated levels of COHb and/or MetHb. Note: High levels of COHb or MetHb may occur with a seemingly normal SpO₂
• Severe anemia.
• Very low arterial perfusion.
• Hypocapnic or Hypercapnic conditions.
• Excessive motion.
• Vasospastic disease such as Raynaud's.
• Hemoglobinopathies and synthesis disorders (e.g., thalassemias, Hb s, Hb c, sickle cell).
• Peripheral vascular disease.
• EMI radiation interference.

Inaccurate RRp readings may additionally be caused by:

• Low arterial perfusion.
• Motion induced artifact.
• Severe anemia
• Arrhythmia

Cleaning and Service Warnings and Cautions

The following can cause damage that may impact the performance of your Masimo W1:

• Do not attempt to sanitize or sterilize using heat, steam, boiling or similar means.
• Clean only with the solutions listed in this manual.

Do not attempt to remanufacture, recondition, or recycle the Masimo W1 as these processes may damage the electrical components, potentially leading to patient harm.

Only perform maintenance procedures specifically described in the manual. Otherwise, return the Masimo W1 for servicing.

Do not touch, press, or rub the watch face with abrasive cleaning compounds, instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the display.

To avoid permanent damage to the Masimo W1, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended.

Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean the Masimo W1. These substances affect the device's materials and device failure can result.

Do not submerge Masimo W1 in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage Masimo W1.