8 |
GB
GB
| 9
CLINICAL ACCURACY VALIDATION METHOD
This device is an adjusted mode clinical thermometer
the validated information for clinical accuracy in each adjusted mode are:
GroupA1:
∆cb=-0.01°C, L
A
=0.18,
δ
r = ±0.08°C
GroupA2:
∆cb= 0.06°C, L
A
=0.22,
δ
r = ±0.08°C
GroupB :
∆cb=-0.01°C, L
A
=0.20,
δ
r = ±0.07°C
GroupC :
∆cb=-0.01°C, L
A
=0.18,
δ
r = ±0.07°C
∆cb: CLINICAL BIAS
L
A
: LlMITS OF AGREEMENT
δ
r: CLINICAL REPEATABILITY
ERROR CODES
When a malfunction or incorrect temperature measurement occurs, an error message will
appear as described below.
LCD Display
Cause
Solution
It may be the thermometer
probe is not in direct
contact with the ear canal
Check that the thermometer is in
direct contact with the ear canal
The temperature measured
is lower than 34°C (93.2°F)
Operate the thermometer only
between the specified temperature
ranges. If necessary, clean the
sensor tip. In the event of a
repeated error message, contact
your retailer or Customer Services.
The temperature measured
is higher than 43°C
(109.4°F)
The operating temperature
is not in the range
15°C~35°C (59°F~95°F)
Operate the thermometer only
between the specified temperature
ranges.
