Ortivus AB 410000409 ユーザーズマニュアル
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10 Appendix
10.5 Technical specification
10.5.1 Classification of medical device
MobiMed 300 is classified as:
• Class IIb according to the Medical Device Directive (MDD).
• Class IIb according to the Medical Device Directive (MDD).
• Class II according to the Food and Drug Administration (FDA).
• Class III according to Health Canada.
10.5.2 ECG specifications
The following electrodes have been tested and approved:
• Niko medical products, 4060 / 4420 / 4610.
• Niko medical products, 4060 / 4420 / 4610.
• 3M, Red dot 2237 / 2249 / 2255.
• ConMed, Cleartrace 1700 - 030.
• Medicotest Blue sensor P-00-S / R-00-S / VL-00-S / M-00-S / L-00-S.
• MSB Monitab (List No. 1414).
Input signal range
±5 mV
Input DC range
±300 mV
Sensitivity
2.5 µV/LSB (referred to input)
Sampling frequency
500 Hz
Band width
0.05 - 170 Hz
Heart rate range
15 - 300 bpm (beats/minute)
Resolution, heart rate
1 bpm
Accuracy, heart rate
±1 bpm
Update, heart rate value
Value based on last 10 seconds of
analysed ECG, not including beats
occurring during bad signal quality. If less
than 5 seconds since fatal lead failure,
invalid value is presented.
Mains interference
Filter for suppression of 50 or 60 Hz
mains interference.