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.
4.2 Disinfecting
Make sure you have cleaned the Vave Probe before beginning disinfection (see previous section, “Cleaning”).
Before you begin, determine the level of disinfection by referring to Spaulding Classification section of
this manual.
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Dierent levels of disinfection require dierent steps, not just dierent solutions.
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The Vave Probe is not designed for sterilization and cannot be sterilized before or between uses.
Intermediate-Level Disinfection
After cleaning, choose low- or intermediate-level disinfectants compatible with your Vave Probe. Follow the
label instructions for preparation, temperature, solution strength, and duration of contact. Make sure you
have removed the battery and cleaned the Vave Probe before beginning disinfection (see previous section,
“Cleaning”).
1. Use a compatible premoistened disinfectant wipe (CaviWipes™) to wipe the probe and battery for 1 minute.
2. Air-dry the probe and battery or towel-dry with a clean, non-linting cloth.
3. Examine the probe for any damage, such as cracks or splitting where fluid can enter. If any damage is evident,
discontinue use and contact Vave Health.
High-Level Disinfection
If the Vave Probe has come into contact with broken skin, mucosal membranes or blood, you must perform
high-level disinfection. Make sure you have removed the battery and cleaned the Vave Probe before beginning
disinfection (see previous section, “Cleaning”).
1. Check the expiration date and prepare the disinfectant solution following the label instructions for solution
strength and disinfection duration .
2. Using the disinfectant CIDEX
®
OPA, at a temperature of 23°C (73°F), immerse the probe and the battery in the
undiluted disinfectant solution for the required duration.
3. Rinse the probe and battery using the instructions on the disinfectant label.
4. Air-dry the probe and battery or towel-dry with a clean, non-linting cloth.
5. Examine the probe for any damage, such as cracks or splitting where fluid can enter. If damage is evident,
discontinue use of the probe and contact Vave Health.
4.3 Spaulding Classification
The level of cleaning and disinfection required for your Vave Probe is based on the Spaulding classification
system. Following the correct classification will help reduce cross-contamination and the spread of infection.
Each Spaulding classification mandates a specific level of cleaning and disinfection of equipment, before it can
be used for the next exam. Determine the Spaulding classification based on Use.
Class Use Method
Non-Critical Class Touches intact skin Cleaning followed by intermediate disinfection
Semi-Critical Class Touches mucous membranes and non-intact skin Cleaning followed by high-level disinfection (HLD)