16.6 In-Home Performance Study Report Summary
Owlet conducted a prospective study in 35 infants between 1 and 18 months of age wherein the accuracy of Dream Sock
was evaluated relative to an FDA-cleared pulse oximetry device. 71.4% of the study subjects were male. The mean weight of
subjects was 17.2 lbs with a range of 9.5 to 26 lbs. Fitzpatrick scores (a measure of skin tone/pigmentation) were primarily 2
(27/35, 77.1%), with 5 subjects (14.3%) having scores of 5 or 6.The SpO
2
and PR average root mean square (A
RMS
) values, a
measure of agreement, were 2.16% with a 95% confidence interval of 1.89% to 2.42% and 3.53 with a 95% confidence
interval of 3.08 to 3.98, respectively. There were no differences seen in accuracy dependent on age, sex, or Fitzpatrick score.
During infant behaviors (i.e., wiggling, feeding) associated with the highest motion levels, the mean SpO2 A
RMS
value was
2.39% with 95% confidence interval 1.73% to 3.05%; PR mean A
RMS
during highest motion conditions was 5.02 with 95%
confidence interval of 3.38 to 6.56.
No serious adverse events were observed during the study.
17. Cybersecurity Information
17.1 Ensuring Secure Access
Secure your account by creating a strong password:
● Do not use personal information (e.g., email, username, birthday, etc).
● Use a complex password. A minimum of 8 characters that combine numbers, symbols, and both uppercase and lowercase
letters.
● Avoid using words that are in the dictionary.
● Avoid using the same password for each account.
● Do not share your password.
● Random passwords are the strongest to use.
Avoid using free public Wi-Fi to connect the App to the Base Station.
Keep your data safe:
● Verify the network you are using
● Use a VPN, if possible
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