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.
Cleaners & Disinfectants
• Use only cleaners and disinfectants recommended by Vave Health and carefully follow all manufacturer instructions.
• Disinfectants are recommended based on their chemical compatibility (not their biological eectiveness) with
product materials. For the biological eectiveness of a disinfectant, see the guidelines and recommendations of
the disinfectant manufacturer, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
Minimizing the Eects of Residual Disinfectant
When using an OPA-based disinfectant, residual solution may remain on your probe if you do not carefully follow
the manufacturer’s instructions. Vave also recommends limiting probe soaking to the minimum time recommended
by the disinfectant manufacturer.
Factors Aecting Disinfectant Ecacy
The following factors will aect the ecacy of a disinfectant solution:
• Number and location of microorganisms
• Resistance level of microorganisms
• Concentration and potency of disinfectant
• Other physical and chemical factors
• Organic and inorganic matter
• Duration of disinfectant exposure
• Biofilms
5.2.4 Clinical Safety
Syringe Safety
If the needle is not visible, do not perform the needle procedure.
• Thin needles can bend when entering tissue. Verify the needle’s position by identifying the echoes from the needle.
• Make sure you are not using a false needle image to locate the needle. False needle images can result from
reverberations or other tissue artifacts.
Defibrillator Safety
If you are using the Vave Personal Ultrasound and defibrillation is required, use defibrillators that do not have
grounded patient circuits. To determine whether a defibrillator patient circuit is grounded, see the defibrillator
service guide, or consult a biomedical engineer.
Before defibrillation, remove any part of the system that is in contact with the patient.
5.2.5 Biological Safety
Latex
The Vave Ultrasound System does not contain any natural rubber latex.
The following are FDA recommendations on latex awareness:
• When taking general histories of patients, include questions about latex sensitivity. For surgical and radiology
patients, spina bifida patients and health care workers, this recommendation is especially important. Questions
about itching, rashes, or wheezing after wearing latex gloves or inflating a toy balloon may be useful. For patients
with positive histories, flag their charts.
• If latex sensitivity is suspected, consider wearing a non-latex glove over the latex glove if the patient is sensitive.
If both the health professional and the patient are sensitive, a latex middle glove could be used. (Latex gloves
labeled “Hypoallergenic” may not always prevent adverse reactions.)
• Whenever latex comes in contact with mucous membranes, be alert to the possibility of an allergic reaction.
• If an allergic reaction does occur and latex is suspected, advise the patient of a possible latex sensitivity and
consider an immunologic evaluation.
• Advise the patient to tell health professionals and emergency personnel about any known latex sensitivity before
undergoing medical procedures.