BiWaze Cough - User Reference Manual
57
•
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation
and testing (Biocompatibility)
•
ISO 13485: 2016: Medical Devices Quality Management Systems
•
ISO 14971:2012 : Application of Risk Management for Medical Devices
12.5
Device classifications
AC
Voltage
Source
100
to
240VAC,
50/60
Hz
AC Power Supply
Input: 100-240 V, 50/60 Hz 1.0-
2.0A
IEC 60601-1 & IEC 60601-1-2
certified
Lithium Ion Battery
Power: 88 Whr
Capacity: 3200 mAh
IEC 62133-2 certified
Type
of
Protection
Against
Electric
Shock
Class
II
Classification According to Directive
93/42/EEC
Class IIa
Degree
of
Protection
Against
Electric
Shock Type
BF
Applied
Part
Patient applied part
Face mask and mouth piece
Degree
of
Protection
against
Ingress
Exposure
Protection,
IP21
Mode
of
Operation:
Intermittent (30 mins ON – 15
mins OFF)
12.6
Wireless communication
Feature
Dimension
Bluetooth Specification
Bluetooth Compliance
Bluetooth 4.2 Secure Connection Compliant and
CSA2 Support
Frequency
2.4 to 2.48 GHz
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