Stork Vitals+ Safety Information
Masimo Corporation 7 www.masimo.com
Who the Device is intended to be used on
(Indications for Use)
Intended Use
The Masimo Stork™ is a wearable device intended for the monitoring of multiple
physiological parameters.
Indications for Use
The Masimo Stork™ is indicated for the spot-checking and continuous monitoring of
functional oxygen saturation of arterial hemoglobin (SpO
2
) and Pulse Rate (PR) during no-
motion, motion, and low perfusion conditions of infants and neonates who are 0 to 18 months
of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin
temperature measurements of infants and neonates who are 0 to 18 months and between 6
to 30 lbs. Masimo Stork™ is indicated for use in home environments.
The Masimo Stork™ can be used to supplement a caregiver's decision to seek additional
guidance for the care of an infant or neonate. It is not intended to provide notifications for
every episode of the unexpected occurrences of elevated or depressed PR or a low SpO
2
;
rather, the Masimo Stork™ is intended to provide a notification only when sufficient data are
available for analysis.
The Masimo Stork™ is not intended to replace the monitoring, diagnosis, or treatment
provided by a physician or healthcare provider. The Masimo Stork™ is not intended for use
with infants and neonates previously diagnosed with cardiovascular or respiratory disease
or conditions.
Safety Information
Before using Stork, read the following safety information carefully. Always consult a
physician if you have concerns. Call emergency services if you believe your baby is having a
medical emergency. Do not rely on Stork for a clinical assessment. A clinical assessment of
your baby should be done by a physician.
Safety Use Information
WARNING: For safe use, do not use any component of the Stork System if it appears
damaged.
WARNING: Do not adjust, repair, open, disassemble, or modify Stork. Such changes may
lead to injury and/or incorrect readings.
To Next Page
Loading...