User's Manual

Vave Personal Ultrasound • USER MANUAL
47
CONFIDENTIAL & PROPRIETARY. CAUTION — Investigational device. Limited by Federal law to investigational use. Not commercially available in the US.
6 References
6.1 Compliance Statement
The Vave Personal Ultrasound system complies with national standards and laws. Users are responsible for
ensuring that the chosen mobile device and probe are compliant with the law in the jurisdiction where the
product is used. Vave Health meets all regulatory standards listed in this chapter.
6.2 The Vave Probe Personal Ultrasound System
6.2.1 Product Classification
• Device with scanners (internally powered ME equipment):
– US FDA: Class II
• Scanners: Type BF applied parts, IP67
• Battery: IP67
• Ordinary Equipment/Continuous Operation
• Non-AP/APG
6.2.2 Product Model Number
The model reference for the Vave Personal Ultrasound system, components, or accessories will consist
of a 3-character alphanumeric:
Product Model Reference
Vave Personal Ultrasound VUS
Vave App VUA
Vave Phased VP3
Vave Battery Charger VCG
Vave Battery VLN
Probe Cap VCP
Each scanner has a unique serial number assigned, which is used to track quality control. The following format of the
serial number will be used:
<3-character model reference>-<2-digit numerical revision>-<2-digit year and 2-digit month>-<4-digit running
number>
Example: VUS-01-1809-0001