Masimo Stork Vitals+ - Performance Warnings; General

Stork Vitals+ Safety Information
Masimo Corporation 9 www.masimo.com
Performance Warnings
General
WARNING: Do not use the device on preterm babies as they may have foot sizes that will
not fit the smallest Stork Boot.
WARNING: Do not use the device as an apnea monitor or as a monitor to prevent sudden
infant death syndrome (SIDS). Oxygen level changes may be delayed from when breathing
actually stops.
WARNING: Do not diagnose or medicate your baby based on the measurements. Always
consult your doctor.
WARNING: Properly apply the Stork Sensor according to the instructions in this manual.
Applying the Sensor incorrectly could result in incorrect or no readings.
WARNING: Displayed parameter(s) may not be accurate when a low SIQ or low
confidence message is provided. You should consider reapplying the sensor. Check the
sizing of the Stork Boot and Straps being used.
WARNING: The Stork is not intended to detect every instance of elevated or depressed
Pulse Rate, or low Oxygen Saturation (SpO
2
). The notifications are intended to identify
instances of the pulse rate and SpO
2
moving outside preset thresholds and when sufficient
signal quality is present.
CAUTION: The sensor and boot should not be worn with a sock as the sensor needs to
come in contact with baby's skin to work accurately.
CAUTION: Check the volume and settings of the alarms so that you can hear them without
interrupting the sleep of your baby.
CAUTION: Check that the Stork notifications can be heard from other rooms in your home,
especially when noisy appliances such as vacuum cleaners, dishwashers, clothes dryers,
televisions, or radios are operating.
CAUTION: Avoid using Stork Sensor under bright light sources and direct sunlight to
maintain the performance of the device.
CAUTION: Keep the Stork Camera plugged in while in use. Loss of power may limit the
notifications available.
CAUTION: Do not connect the Stork Camera to an electrical outlet controlled by a wall
switch or dimmer. Someone may accidentally turn the power off to your Stork Camera.