Citizen CTD504 - Page 14

Statistic of subjects for Infrared Ear Thermometer
Unit:Û&
EN12470-5
Statistic of Subjects
Group A
Group B
Group C
Repeatability(≦0.3)
0.109
0.104
0.104
Mean bias(≦±0.2)
-0.088
0.017
-0.036
SD(≦0.4)
0.232
0.267
0.215
ISO 80601-2-56 for Infrared Ear Thermometer
Statistic of
Subjects
Group A
Group B
Group C
ALL
A1
A2
CLINICAL
5(3($7$%,/,7<ıU
0.113
0.121
0.108
0.102
0.112
CLINICAL BIAS
¨FE
-0.088
-0.056
-0.105
0.017
-0.036
LIMITS OF
AGREEMENT (LA)
0.194
0.222
0.180
0.185
0.187
To prove the accuracy of CTD504, we perform clinical experiments at one hospital
by professionals on 3 groups of test subjects: new born to 1-year-old for Group A,
1-year-old to 5-year-old for Group B, and 5-year-old or above for Group C.
Each group consists of 50 effective test subjects, and at least 30 % of them are
febrile, with the exception for those who are under 3-month-old.
All clinical test procedures are performed in compliance with EN 12470-5 and ISO
80601-2-56.