Masimo Corporation 5 www.masimo.com
General Warnings and Precautions
WARNING: Always consult your physician regarding clinical decisions. Do not rely on the readings as the only basis for medical decisions. Incorrect clinical decisions may
result in harm. Before use, read the following carefully.
Safety Warnings
WARNING: Do not use if it appears damaged or if you think it is damaged. Damage to the device can result in exposed sharp edges that may cause harm.
WARNING: Do not adjust, repair, open, disassemble, or modify the Masimo W1. Damage to the device may result in degraded performance and/or injury.
WARNING: Do not use in areas filled with flammable gases: such as anesthetics, oxygen, oxygen-enriched environments, or nitrous oxide to prevent risk of fire.
WARNING: Keep Masimo W1 away from small children. Small items may become a choking hazard.
Note: Use and store as directed in the Specifications section in this manual.
Performance Warnings
WARNING: Do not self-diagnose or self-medicate based on the measurements. Always consult your doctor regarding clinical decisions.
WARNING: See Risk and Benefit Section for information on limitations and ways to get the most accurate readings.
WARNING: Do not use Masimo W1 as an apnea monitor. Oxygen changes may be delayed from when your breathing actually stops.
WARNING: The Masimo W1 may not fully charge if the room is too hot.
WARNING: Check the fit of the watchband periodically. Avoid wearing the Masimo W1 too loose or too tightly to avoid inaccurate readings or pressure injury.
WARNING: Keep electronics with communication capabilities greater than 30 cm (12 inches) to any part of the Masimo W1. Otherwise, degradation performance could
result.
CAUTION: 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.
CAUTION: Do not place the Masimo W1 near electrical equipment that may affect the device, preventing it from working properly.
CAUTION: Failure to charge Masimo W1 promptly after a Low Battery notification message may result in the device shutting down.
CAUTION: To establish and maintain the minimum Quality of Service of the Masimo W1, the keep the Masimo W1 within ~7 m (~23 ft.) line of sight to the smart device App.
CAUTION: Move the devices away from sources that may interfere with Bluetooth connection. The presence of other devices that may create radio frequency interference
(RFI). This may result in loss of Quality of Service. Example devices that cause RFI are other smart devices, devices with remote controls, and baby monitors.
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.
HR Performance
WARNING: Make sure the Masimo W1 makes good contact with your wrist and your finger. Poor contact can result in no or incorrect readings.
WARNING: Avoid wearing watch over compromised skin, excessive hair, or scar tissue, as this may result in incorrect readings.
WARNING: Pacemakers that create fusion beats (pace pulse on top of the QRS complex) may not be detected by Masimo W1.
WARNING: HR reading can be affected by the following:
• Poor electrode contact.
• Conditions that may increase skin impedance (e.g., dry skin).
• Weak heart signals.
• Excessive movement.
• Electrode or electrodes placement over skin injuries or hair.
• Abnormal heart rhythms due to physiological conditions or induced through external factors (e.g., cardiac arrhythmias, ventricular tachycardia/fibrillation, seizures
etc.).
• EMI radiation interference.
• Pacemakers
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