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1.3
Precautions
The WatchPAT should not be used in the following cases:
1. Use of one of the following medications: alpha blockers, short acting nitrates (less than 3
hours before the study).
2. Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
3. The WatchPAT is not indicated for children who weigh less than 65 lbs / 30 kg.
1.4
Additional Precautions specific to pediatric use
The WatchPAT is indicated for use in patients 12 years and above.
The following Precautions and Notes are referring to pediatric aged 12-17 years.
Precautions:
1. Pediatric patients with severe comorbidities such as Down syndrome, neuromuscular
disease, underlying lung disease or obesity hypoventilation should be considered for sleep
study in a laboratory polysomnograph (PSG) rather than a home sleep testing (HST).
2. It is recommended that the physician makes sure that the patient and his/her guardian are
aware that the use of specific drugs and other substances used to treat ADHD, antidepressants,
corticosteroids, anticonvulsants, use of caffeine, nicotine, alcohol and other stimulants might
interfere with sleep and affect the sleep study's conditions.
NOTES:
• PAT Respiratory Disturbance Index (PRDI) is indicated for patients 17 years of age
and above.
• The Chest Sensor safety and effectiveness was not validated on pediatric patients
• Special attention on training the pediatric patient and / or his accompanying
individual on use and placement of the device prior to initiating a sleep study with
the WatchPAT device (for further details see section 7 and section 8).
WatchPAT™ONE System
7
Operation Manual
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