nanny BM-02 Mode D'emploi page 9

Power
Standby current
Alarm current
Battery low indication level
Monitored breathing frequency
Average battery life - home health care
Average battery life - health care providers
Sensor pad
Acoustic alarm level
Control unit
Operating conditions
Transport and storage
Product characteristics
Meets the following standards:
Manufacturer
Medical electrical device (with attachment that detects energy from the patient)
ME device
Electromagnetic compatibility (a set of normative requirements for a ME device)
EMC
Sudden infant death syndrome
SIDS
Designation of the attachment part type BF
General mandatory action sign
The device's immunity to the ingress of foreign bodies and water (Ingress protection class)
IP31
Product identifi cation by barcode, Prefi x: 0xxxy product identifi cation (02594 unit; 02593 pad):
0xxxxynnnnnnnn Suffi x: nnnnnnnn serial number
MD
Medical device
UDI
UDI (Unique Device Identifi er)
(01)08594052530056
(10)2206310005
(21)00005000000001
Technical data
Defi nitions and symbols
(01) = UDI-DI of medical device
(10) = LOT (batch number)
(21) = SN (serial number)
3 V 2×1.5 V AA LR6 size alkaline batteries
0.2 mA
100 mA
2.38 V ± 0.15 V
<8 breaths/minute (i.e.<0.13 Hz)
6 months (gets reduced by frequent alarm testing)
4 months (gets reduced by frequent alarm testing)
type BM-02D, max. size 305×500×15 mm,
weight: 1000 g, material: PVC-P, cable length 1.2 m
80 dB @ 1 m ± 5 %
max. size 140×80×35 mm, weight 123 g, material ABS
+5 °C to +40 °C, relative humidity 15 % to 93 %,
700 – 1200 hPa
0 °C to +40 °C, relative humidity 10 % to 85 %,
700 – 1200 hPa
BM-02D type BF applied part
EN 60601-1 ed. 2 2:2007 + A1:2014
EN 60601-1-2 ed. 3:2016
EN 60601-1-6 ed. 3:2010 + A1:2015
EN 60601-1-11 ed. 2:2016
EN ISO 10993-1:2021, EN 62366-1:2019
EN ISO 14155:2021, EN 14971:2020
EN ISO 13485 ed. 2:2016, EN IEC 63000:2019
EN 62304:2006 + A1:2016
General warning sign
Refer to instruction manual/booklet
9
MFV52124
(859405253BM02ES)
EN