User's Manual
Vave Personal Ultrasound • USER MANUAL
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CONFIDENTIAL & PROPRIETARY. CAUTION — Investigational device. Limited by Federal law to investigational use. Not commercially available in the US.
“Diagnostic ultrasound is recognized as a safe, eective, and highly flexible imaging modality capable of
providing clinically relevant information about most parts of the body in a rapid and cost-eective fashion.”
(World Health Organization)
5.2.1 Product Safety
Vave Health is responsible for the safety of the Vave Probe. The safety of connected mobile devices is the user’s
responsibility. Always read and follow the safety guidelines for your smart device.
Product Warnings
The following actions may cause serious or fatal injury:
• Operating the Vave Probe without proper training on use and safety.
• Attempting to remove, modify or override any element of the system, especially safety features.
• Using the system with any product not specifically recognized as compatible with the Vave Probe.
• Continuing use after the first sign or suspicion of system malfunction or defect. If suspected, contact
Vave immediately.
• Using the system for anything beyond its intended function.
Product Compatibility
The Vave Probe comes with a battery, battery charger and a power supply for the charger. Do not use your Vave
Probe or Vave Battery Charger in combination with other products or components not made by Vave, unless Vave
expressly recognizes those other products or components as compatible.
Any modifications to the Vave system can be made only by Vave or by third parties expressly authorized by Vave
to do so. Modifications must comply with all applicable country and regional laws and regulations. Modifications
made without the appropriate training, or by using unapproved parts, may damage the system or cause personal
injury. The system limit for patient contact temperature is 43°C (109°F) and acoustic output values follow U.S. Food
and Drug Administration limits. If the power monitor protection circuit senses an over-current condition, the probe
will shut o to prevent overheating and limit acoustic output.
5.2.2 Battery Safety
If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use,
recharging or storage, immediately remove it and contact Vave. If the battery fails to charge fully, replace it.
Do not discard the battery by fire.
The following actions may damage the battery:
• Using or charging the battery near a heat source
• Touching battery contacts
• Opening, crushing, puncturing or short-circuiting contacts
• Connecting the positive and negative terminals directly to metal objects
• Using the battery in temperatures below -20°C (-4°F) or above 60°C (140°F)
• Charging the battery in temperatures below 10°C (50°F) or above 45°C (113°F)
• Forcing the battery into the system. The polarity of the battery terminals is fixed and cannot be reversed
• Connecting the battery to an electrical power outlet
• Charging the battery using non-Vave equipment
• Leaving the battery in direct sunlight
5.2.3 Cleaning Safety
It is important to clean and maintain the Vave Ultrasound System. Thorough cleaning is particularly important for
pieces of peripheral equipment, because they contain electromechanical parts. It is your responsibility to clean
and disinfect your Vave Probe in accordance with the cleaning and disinfecting instructions in this manual. For
instructions on cleaning and disinfecting, refer to Cleaning and Disinfecting sections section of this manual.