Seca mVSA 535 - COVIDIEN TM FILAC TM 3000 Temperature Measurement

Technical data • 125
English
17-10-05-353-002g_10-2020 B
COVIDIEN
TM
FILAC
TM
3000
temperature measurement
Pulse rate:
• Measuring range for inflation
• Measuring range for deflation
• Accuracy (under laboratory conditions, verified with CuffLink patient
simulator from Fluke)
45 min
-1
– 200 min
-1
30 min
-1
– 240 min
-1
max. ± 3 min
-1
/ 3 %,
the larger value in each case applies
IEC 60601-1: Medical electrical device, type BF (defibrillation-protected)
seca blood pressure module
COVIDIEN
TM
FILAC
TM
3000 temperature module
Measurement modes Direct, predictive
Measuring position:
Blue probes
Red probes
Oral, axillary
Rectal
Measuring range
• Direct mode
• Predictive mode
30 °C – 43 °C (86 °F – 109.4 °F)
35.5 °C – 42 °C (95.9 °F – 107.6 °F)
Measuring time (following application at measuring position)
Direct:
• All measuring positions
Predictive:
• Oral, no fever
• Oral, fever
• Axillary
• Rectal
60 – 120 sec
3 – 5 sec
8 – 10 sec
8 – 12 sec
10 – 14 sec
Switchover time from predictive mode to direct mode
• Measuring position not detected (following removal from probe cover)
• No stable temperature value obtained (following application)
60 sec
70 sec
Accuracy (water bath):
• Direct mode
• Predictive mode
± 0.1 °C ( ± 0.2 °F)
± 0.1 °C (± 0.2 °F)
IEC 60601-1: Medical electrical device, type BF
Type of protection against ingress of liquids IP21
Clinical accuracy
a b
Measuring position: Oral Axillary Rectal
d (age group I)
-0.44 -0.01 0.09
L
A
(age group I)
1.01 0.86 0.99
d (age group II)
-0.21 -0.04 0.12
L
A
(age group II)
0.75 0.65 0.67
σ
r
0.34 0.28 0.28
a.The clinical accuracy of the COVIDIEN
TM
FILAC
TM
3000 was determined in a clinical study in accordance with EN 80601-2-
56. Clinical bias d
and limits of agreement L
A
are quoted for the age group and measuring position in question. Clinical re-
peatability σ
r
is independent of age. The reference body sites of the reference thermometer used in the clinical study corre-
spond to the measuring positions quoted.
b.The age of the test subjects in age group I is between 3 and 4 years. The age of the subjects in age group II is 5 and above.