4
e. Supplemental oxygen use at night
f. Cardiac arrhythmia
g. Atrial fibrillation
h. Tics or tremors of the head
Unassisted use of the ARES by patients with any of these conditions may result in poor
signal quality that could lead to a misdiagnosis by the physician.
3. The ARES is not recommended for use by patients with the following conditions:
a. Sensitivity of skin or scalp and/or open wounds on the forehead or scalp
b. Allergic reactions to extended exposure to synthetic fabrics (e.g., polyester,
rayon)
c. Upper respiratory infection or congestion
d. Active, contagious, infectious disease (ex.: MRSA, C. diff) where barrier
precautions are advised.
NOTE: If a device is used with a person with active, infectious disease the
customer must alert Watermark Medical and arrange for the return of the
device through Customer Support. The device cannot be used on any other
patient and must be returned for destruction. The customer is responsible for
replacement charges.
e. Inability to sleep at least 5-hours per night or a total of 8-hours over two nights.
f. Inability to sleep with head reclined (less than 60 degree angle)
g. Head circumference less than 20 inches or greater than 25 inches
Use of the ARES by patients with any of these conditions may result in poor signal quality
that could lead to a misdiagnosis by the physician.
4. The proper use of the ARES requires patients to be dexterous in both hands, capa-
ble of reading and comprehending instructions, and able to see and hear the audio
and visual indicators. If the patient cannot meet these requirements the result may
be poor signal quality leading to a misdiagnosis by the physician. Such patients
require assistance to ensure that the ARES records accurate data.
5. ARES use under any of the following conditions may result in poor signal quality that
could lead to a misdiagnosis by the physician:
a. Strap not adjusted properly; too loose or too tight.
b. Forehead not prepared according to instructions (e.g., makeup, lotion or hair
under the sensor).
c. Loud snoring bed partner or significant ambient noise.
6. The ARES device is not to be used on children.
