Covidien Tm Filac Tm 3000 Temperature Measurement - Seca mVSA 535 Instructions For Use Manual

Pulse rate:
• Measuring range for inflation
• Measuring range for deflation
• Accuracy (under laboratory conditions, verified with CuffLink patient
simulator from Fluke)
IEC 60601-1: Medical electrical device, type BF (defibrillation-protected)
COVIDIEN FILAC
TM TM
temperature measurement
Measurement modes
Measuring position:
Blue probes
Red probes
Measuring range
• Direct mode
• Predictive mode
Measuring time (following application at measuring position)
Direct:
• All measuring positions
Predictive:
• Oral, no fever
• Oral, fever
• Axillary
• Rectal
Switchover time from predictive mode to direct mode
• Measuring position not detected (following removal from probe cover)
• No stable temperature value obtained (following application)
Accuracy (water bath):
• Direct mode
• Predictive mode
IEC 60601-1: Medical electrical device, type BF
Type of protection against ingress of liquids
Measuring position:
(age group I)
d
L (age group I)
A
(age group II)
d
L (age group II)
A
σ
r
a.The clinical accuracy of the COVIDIEN
56. Clinical bias d and limits of agreement
peatability σ is independent of age. The reference body sites of the reference thermometer used in the clinical study corre-
r
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.
96 •
seca mVSA 535
seca blood pressure module
3000
COVIDIEN FILAC
TM
Clinical accuracy
Oral
TM FILAC TM
L
are quoted for the age group and measuring position in question. Clinical re-
A
3000 temperature module
TM
a b
Axillary
-0.44
1.01
-0.21
0.75
0.34
3000 was determined in a clinical study in accordance with EN 80601-2-
45 min – 200 min
-1
30 min – 240 min
-1
max. ± 3 min
the larger value in each case applies
Direct, predictive
Oral, axillary
30 °C – 43 °C (86 °F – 109.4 °F)
35.5 °C – 42 °C (95.9 °F – 107.6 °F)
60 – 120 sec
10 – 14 sec
± 0.1 °C ( ± 0.2 °F)
± 0.1 °C (± 0.2 °F)
Rectal
-0.01
0.86
-0.04
0.65
0.28
-1
-1
/ 3 %,
-1
Rectal
3 – 5 sec
8 – 10 sec
8 – 12 sec
60 sec
70 sec
IP21
0.09
0.99
0.12
0.67
0.28