Covidien Filac 3000 Temperature; Temperature Measurement Covidien Tm Genius ® 2; Masimo Set Spo Measurement - Seca mVSA 535 Instructions For Use Manual

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
Measurement site:
(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 measurement sites quoted.
b.The age of the subjects in age group I is between 3 and 4 years. The age of the subjects in age group II is 5 and above.
Temperature measurement
COVIDIEN GENIUS
TM
Measuring method
Measuring range (in-ear)
Measuring time
Resolution
Accuracy
• Ambient temperature: 25 °C (77 °F)
Target temperature: 36,7 °C – 38,9 °C (98.1 °F – 102 °F)
• Ambient temperature: 16 °C – 33 °C (60.8 °F – 91.4 °F)
Target temperature: 33 °C – 42 °C (91.4 °F – 107.6 °F)
EN 60601-1: Medical electrical device, type BF
Type of protection against ingress of liquids
Masimo SET ® SpO measurement
2
Measurement
Measuring method
98 • /
seca mVSA 535 seca mBCA 525
TM
COVIDIEN FILAC
Oral
TM
FILAC
L
are quoted for the age group and measurement site in question. Clinical re-
A
2
®
COVIDIEN TM
General technical data
Masimo SET
TM
3000 temperature module
a b
Clinical accuracy
Axillary
-0.44
1.01
-0.21
0.75
0.34
TM
3000 was determined in a clinical study in accordance with EN 80601-2-
GENIUS ® 2 in-ear thermometer
a b c d e f g
®
SpO module
2
60 – 120 sec
8 – 10 sec
8 – 12 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
Direct mode
33 °C – 42 °C (91,4 °F – 107,6 °F)
Less than 2 sec
0.1 °C; 0.1 °F
± 0.1 °C (± 0.2°F)
± 0,2 °C (± 0,4°F)
Functional oxygen saturation
Spectrophotometry (red/infrared)
3 – 5 sec
60 sec
70 sec
IP21
0.09
0.99
0.12
0.67
0.28
IPX0