Flashback Technologies M1 - M1 Compliance; Nonin 8000 AA Warranty; M1 Warranty

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Electromagnetic Immunity
The M1 is intended for use in the electromagnetic environment specified below. The customer or the
user of the M1 should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment –
Guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80 MHz
20 V/m
80 MHz to
2.7 GHz
3 Vrms
6 V rms in ISM and
amateur radio bands
20 V/m
The M1 is suitable for the
electromagnetic environment of
typical homes, commercial or
hospital settings.
The device has also been tested for immunity to proximity fields from RF wireless communications
equipment with the following parameters:
Frequency (Hz)
Modulation
Level V/m
385
Pulse, 18 Hz, 50% DC
27
450
FM, 1 kHz Sine, ±5 Hz Deviation
28
710, 745, 780
Pulse, 217 Hz, 50% DC
9
810, 870, 930
Pulse, 18 Hz, 50% DC
28
1720, 1845, 1970
Pulse, 18 Hz, 50% DC
28
2450
28
5240, 5500, 5785
9
M1 Compliance
The M1 is not compliant with ISO 10993. Therefore, care should be taken to prevent the device from
making contact with the patient’s tissue (note: This does not apply to the sensor which is ISO 10993
Compliant). Metal loops are integrated in the case to attach the device to a litter, rail, or other object.
Opening the case of the M1 will void its warranty and the device will stop functioning. The user cannot
patch or modify the device. The device will maintain its compliancy throughout its service life.
Nonin 8000AA Warranty
1 year from the date of delivery.
The device’s expected service life is 1 year.
M1 Warranty
1 year from date of delivery.
The device’s expected service life is 5 years.
The device’s expected shelf life is 2 years (remove battery when storing).