Reference Manual

BiWaze Cough - User Reference Manual

• 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