BodyCAP e Celsius - The Characteristics

16
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
"Radiated RF disturbances"
The label contains an IEC 60601-1-2 symbol:
"Follow the using instructions"
"Applied part type BF"
The label contains an IEC 60601-1 symbol:
"It’s not a drug"
"Index of protection"
"Medical device CE marked by the notied body NNNN"
In addition, the label species the following mentions:
IPxx
NNNN
"Do not dispose of the device with municipal waste"
(> Precautions for use - page 6 )
"Keep out of reach of children"
"Prohibited to minors"
Dimensions: Length: 17.7 mm
Diameter: 8.9 mm
Weight: ≈ 1,7 g.
Operating temperature range: 25°C - 45°C
Temperature accuracy of the integrated sensor: ± 0.1°C in the range 36-41°C (physiological range), ±
0.13°C outside the physiological range
Temperature resolution: 0,01°C
Heating response time: <150s (for +2°C)
Cooling response time: <100s (for -2°C)
Sampling frequency: 30s ± 2%
Data storage in the capsule: The last 2000 temperature values are stored in the capsule
Maximum transmission distance with the watch: approx. 1 m (environment dependent)
"Medical Device according to Regulation 2017/745"
The label contains a symbol of linked to regulation 2017/745, relating to medical devices,
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