User's Manual

BiWaze® Clear System - User Manual Page | 37
BK0289 BiWaze® Clear Dual Lumen
Breathing Circuit – Adult Small Face
Mask
Coaxial filter, Coaxial breathing tube, handset,
Aerogen® Solo, Adult Small Face Mask
BK0291 BiWaze® Clear Dual Lumen
Breathing Circuit – Adult Child Face
Mask
Coaxial filter, Coaxial breathing tube, handset,
Aerogen® Solo, Adult Child Face Mask
BC21095 Battery Rechargeable battery
BK0388 Quick Reference Guide Acute Care Quick Reference Guide
BK0386 Quick Reference Guide Home Care Quick Reference Guide
BK0381 User Manual Instructions of use for BiWaze Clear
BC20116 Power Cord US Power Cord
BC22506 Mobile Cart (Acute Care Only) Mobile Cart with basket, telescoping pole and
locking caster wheels
BC21083 Carrying Bag Carrying Bag for Home care environment
BC21274 Air Inlet Filter (Pack of 3) Pack of 3 replaceable air inlet filters
BK0371 SPO2 pulse oximeter Pulse oximeter
BK0373 SpO2 soft sensor small SpO2 sensor small size
BK0372 SpO2 soft sensor medium SpO2 sensor medium size
BK0374 SpO2 soft sensor large SpO2 sensor large size
11.7 Standards Compliance
This device is designed to conform to the following standards:
• IEC 60601-1: Medical electrical equipment – Part 1: General requirements for safety
• IEC 60601-1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility
– Requirements and tests
• IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability
• IEC 60601-1-11: General requirements for basic safety and essential performance – Collateral
standard: Requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment
• IEC 62304: Medical device software — Software life cycle processes
• ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing
(Biocompatibility)
• ISO 18562-1:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications
- Part 1: Evaluation and Testing within a Risk Management Process. ISO 14971: Application of Risk
Management for Medical Devices
11.7. 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
Lithium-Ion Battery
Power: 90 Wh
Capacity: 3400 mAh
Type of Protection Against Electric Shock Class II
Degree of Protection Against Electric Shock Type BF Applied Part
Patient applied part Face mask and mouthpiece
Degree of Protection against Ingress Exposure Protection, IP21
Mode of Operation: Intermittent (30 mins ON – 15 mins OFF)
11.8 Wireless communication
Wi-Fi Specification
Feature Dimension
WLAN
IEEE Std 802.11b, 802.11g, and 802.11n with 20 MHz and 40
MHz SISO
Frequency 2412 MHz to 2462 MHz