PrimaBella Frequently Asked Questions

Q: What are the medical conditions for which PrimaBella has FDA clearance?
A: PrimaBella is a patented, non-drug, non-invasive therapeutic treatment for nausea and vomiting. PrimaBella is class II neuromodulation medical device, which has been cleared for sale by the US Food and Drug Administration (FDA) via prescription (Rx), and is indicated for the treatment of nausea and vomiting associated with pregnancy.

Q: How does the PrimaBella work?
A: PrimaBella works by gently stimulating the median nerves in the wrist to modulate nerve impulses and restore normal signals between the brain and stomach, thus reducing nausea and vomiting. More specifically, PrimaBella delivers intermittent impulses that stimulate the body's central nervous system to positively modulate the body's reaction to nausea and vomiting. The net result of this stimulation is normalization of stomach rhythms.

Q: Why do I need a prescription for PrimaBella?
A: PrimaBella requires a prescription for several reasons: These conditions should always be managed by a physician to ensure that PrimaBella is an appropriate part of the overall treatment regimen for each patient. Physicians need to assess nausea & vomiting symptoms as an indicator of a more serious health condition. For insurance reimbursement purposes, it may be advantageous to obtain PrimaBella by prescription.

Q: How do I activate PrimaBella?
A: To activate PrimaBella, press the power symbol located in the center of the PrimaBella face, once. A green light will begin blinking near the intensity setting I.. Press the button a second time to increase stimulation to the next level. The device has a total of five power levels (I, II, III, IV, V), with higher roman numerals corresponding to higher stimulation levels. Note: The flashing light is not synchronized with the tingling sensation you will feel (the tingling sensation will cycle every four seconds). To turn off the device, and place the unit into battery save mode, press and hold the power button in the center of the face for at least 3 seconds.

Q: How do I know if PrimaBella is applied correctly?
A: After identifying the correct area (two finger widths below the first crease on your wrist and between the two tendons) be sure to apply the conductivity gel on the wrist per instructions. Place PrimaBella over the gelled area (device must be turned on and positioned to start at the first setting). You should feel a gentle pulsing or tingling sensation in the palm and/or middle fingers of your hand. This sensation tells you that the device is placed correctly. Tighten the strap, but avoid over tightening to prevent the "tourniquet" effect.

Q: What do I do if I can't feel the tingling?
A: Move PrimaBella slowly around the underside of the wrist over the area two-finger widths below the crease in the wrist. If tingling is still not felt, increase the power level setting and repeat movement. If the tingling is still not felt at the highest setting of V, you should try the following:

1. Follow the "Instructions for Use" carefully to make sure PrimaBella is applied in the correct starting position.
2. Remove PrimaBella, clean the electrodes and wrist gently with a clean cloth and reapply the gel and device. Be sure gel is rubbed to sheen, not in a glob on your wrist. Note: Applying too much gel can cause the tingling sensation to stop.
3. Switch wrists.

Q: Do I always have to use the conductivity gel? How much should I use?
A: Yes, conductivity gel should always be used. The gel helps enhance the conductivity between the electrode pads and the skin, allowing the impulses to penetrate and reach the nerves intended to receive stimulation. You should use a drop, about the size of a pea. The drop should be spread onto the skin, until a sheen remains, covering an area the size of a quarter. Gel should be reapplied every 6-8 hours (2-3 hours for sensitive skin) or when the device is reapplied after washing the wrist area.

Q: What is the proper stimulation level for me?
A: The proper stimulation level varies by individual, but you should always feel some 'tingling' in the palm and/or middle fingers of your hand. This 'tingling' sensation tells you that the device is placed correctly. Then, increase the stimulation to the highest comfortable level.

Q: Will this tingling feeling always be there?
A: You must continue to feel the tingling for the PrimaBella to work. Worn over time, you will become accustomed to the sensation and it will become less noticeable. The tingling sensation does vary with arm movements.

Q: When do I wear the device?
A: For patients anticipating nausea & vomiting, the device can be activated before symptoms arise. Otherwise, turn it on when you start to feel symptoms of nausea, and turn it off when you feel better. Note: You may leave it on the wrist after you turn it off if you are concerned that the symptoms may return.

Q: How quickly does the PrimaBella work?
A: When applied correctly, many patients begin to feel relief within a few minutes.

Q: How long may I wear the PrimaBella?
A: The PrimaBella may be worn as long as necessary. Suggestion: To increase the lifespan of the device, wear it in the proper position and turn it on/off as needed.

Q: How long does the PrimaBella last?
A: PrimaBella is a single patient use device. Used on the average setting (power level III) the device has an active battery life of approximately 150 hours. Be sure to turn PrimaBella "off" when it is not in use. This will allow you to use the device over several days, weeks or months.

Q: Are there any side effects using the PrimaBella?
A: The only known side effect may be slight skin irritation under the electrodes for users who are allergic to certain metals. Electrodes are gold plated to minimize possible irritation. If local skin irritation does occur beneath or around the electrodes site, switch wrists. If symptoms persist, discontinue use. Consult your physician or pharmacist if irritation does not disappear within 24 hours.

Q: Can I use other types of gel, for example, K-Y® Jelly?
A: Only use the conductivity gel specifically provided for use with PrimaBella. The conductivity gel tube included with the PrimaBella should last for approximately 75 applications. For purchase of additional gel, please call 1-866-943-9426.

Q: Is PrimaBella waterproof?
A: PrimaBella is NOT waterproof; however, it is rated as 'Spray and Splash Resistant.' This means that it should continue to perform in most cases of splash contact with water. It should not be submerged, or subjected to long periods of continual exposure to water.

Q: Are there any other uses for the product? May I wear it anywhere else on the body?
A: No. PrimaBella is only intended for use in nausea and vomiting associated with pregnancy and must be worn on the underside of the wrist. Improper placement may affect the results of PrimaBella.