Page 6  Instructions For Use (QWV website)

Warnings and Contraindications

The following warnings help protect the user and ensure the safe and effective use of the INDIGO. Warnings describe issues that could be potentially dangerous to the user if these warnings are ignored. These warnings should be followed at all times. If you have any questions at any time please contact your local representative.

1. WARNING, any unauthorized use or modification of the device may be hazardous.

2. DO NOT use this device if the client/patient has a pacemaker.

3. DO NOT use on clients/patients with epilepsy.

4. DO NOT use on clients/patients with electrical hyper reactivity.

5. DO NOT connect the harnesses over irritated, inflamed, red or broken skin.

6. DO NOT use on pregnant women.

7. DO NOT use on children under 3 years of age.

8. DO NOT use on clients/patients who are under the influence of drugs or alcohol.

9. DO NOT use open containers of fluid on or near the device.

Page 7  Instructions For Use (QWV website)

Cautions

The following Cautions help protect the user and ensure the safe and effective use of the INDIGO. Cautions describe issues that could create problems to the user if those cautions are ignored. Cautions should be followed at all times. If you have any questions at any time please contact your local representative.

1. This device has not been shown to be effected by EMC interference from other devices or cause adverse EMC effects on other devices. Please follow guidelines from the computer manufacturer that you are using with this device as they may have their own specific requirements to follow.

2. The device connected to an ISO certified computer is safe and suitable to be in the client/patient environment. In the case where the computer and device are being used by the client/patient themselves, the limits imposed by the computer would prevent any hazard to the user.

3. Use caution with psychotic clients/patients or clients/patients with histories of electro-shock.

4. Clean the harness after every use.

Undesirable Side Effects

There are no anticipated undesirable side effects from the use of the INDIGO. However, after being in a deeply relaxed state the user may feel a rush of blood to the head (much like when standing up quickly from a crouching position) and therefore feel a little “light headed.” In this situation, have them hold onto something stable until the feeling passes. If the client has been in a fully reclined position, ask them to get up slowly and take their time. Sometimes people feel that deep breaths or a glass of water help them shake off the light headed feeling.

The Quantum Academies  INDIGO Beginners Manual  page 293;

 ***CAUTION*** Possible Undesirable Side Effects:

Before training on the Autonomic Nerval System it is advised to ask your client ““Do you have a history of Vasovagal Episodes, fainting, syncope and/or generalized heart weakness?” If the answer is yes, you need to proceed with caution, and be aware of the symptoms of Vasovagal Episodes:

 A slight feeling of light-headedness after a session. Please note that this may be due to the client’s own health such as low blood pressure, or suddenly standing up after being in a relaxed, reclined position

during the session. If this feeling seems abnormal in any way, or of a concern, then the client should see their primary healthcare practitioner.

 Through biofeedback electrical nerve stimulation; interaction with the CNS the INDIGO may induce an autonomic nervous system cascade that can lead to a Vasovagal crisis. The client might sweat excessively

or report nausea and dizziness. If this occurs, place a cool wet rag over their eyes gently with light pressure, tell the clients to relax and breathe deeply, and wait about 5 to 10 minutes for the Vasovagal Storm to pass. In extreme cases there might be syncope (fainting).

VASOVAGAL Reaction

Biofeedback systems using skin resistance all use stimulation of electricity. Some clients may have a Vasovagal reaction when their system tries to shift from sympathetic nerve dominance to a more relaxing para-sympathetic dominance. If this happens too fast there can be a Vasovagal episode. A Vasovagal episode, Vasovagal response, or Vasovagal attack (also called Neurocardiogenic Syncope) is mediated by the Vagus nerve. When it leads to syncope (fainting) it is called Vasovagal Syncope, which is the most common form of fainting.

Symptoms

 In clients with Vasovagal episodes, the episodes are typically recurrent, usually happening when the client is exposed to a specific trigger. The initial episode often occurs when the person is a teenager, then recurs in clusters throughout their life. Prior to losing consciousness, the individual frequently experiences warning symptoms such as lightheadedness, nausea, sweating, ringing in the ears (tinnitus), uncomfortable feeling in the heart, weakness and visual disturbances such as lights seeming too bright, fuzzy or tunnel vision. These

last for at least a few seconds before consciousness is lost (if it is lost), which typically happens when the person is sitting up or standing. When sufferers pass out, they fall down (unless this is impeded); and when they pass out; effective blood flow to the brain is immediately restored, allowing the person to wake up.

The autonomic nervous system’s physiologic state leading to loss of consciousness may persist for several minutes, so:

1. If sufferers try to sit or stand when they wake up, they may pass out again;

2. The client may be nauseated, pale, and sweaty for several minutes. Vasovagal syncope is rarely life-threatening in and of itself, but is mostly associated with injuries from falling while having an episode.

The Autonomic Nervous System has two parts 1) Sympathetic for stess (fightor-flight) also known as the Thoracic Lumbar, and 2) the Parasympathetic for immunity and digestion, also known as the Cranial Sacral Nerval system. To stimulate the Parasympathetic system apply cold compresses for five minutes to the upper neck and sacrum, and then alternate with warm compresses for five minutes.

What To Do

The method of dealing with Vasovagal syncope focuses on avoidance of triggers, restoring blood flow to the brain, and measures that interrupt the process; such as cold and hot compresses. Also to avoid physical injury due to fainting.

Because Vasovagal syncope causes a decrease in blood pressure, relaxing the entire body as a mode of avoidance isn’t favorable. The client can cross their legs and tighten leg muscles to keep blood pressure from dropping.

Before known triggering events, the client may increase consumption of salt and fluids to increase blood volume. Sports and energy drinks may be particularly helpful.

Clients should be educated on how to respond to further episodes of syncope, especially if they experience pre-warning signs: they should lie down and raise their legs; or at least lower their head to increase blood flow to the brain. If the client has lost consciousness, they should be laid down with their head turned to the side. Tight clothing should be loosened. If the inciting factor is known, it should be removed if possible (for instance, the cause of pain). Wearing graded compression stockings may be helpful. There are certain orthostatic training exercises which have been proven to improve symptoms in people with recurrent Vasovagal syncope.

How do I use my Biofeedback device with a client who has a history of Vasovagal episodes?

Do NOT use maximum settings for too long and stay at the safe calibrated levels. This will reduce the possibility of a Vasovagal episode. Always ask if there is a history of Vasovagal episodes, most often fainting or cold sweats with heart palpitations. If so always use low calibrated settings. Do not try to push therapy after therapy on the client with a Vasovagal episode history. Please always keep a watchful eye on the client who is getting a therapy on electrical stimulation. Be prepared to respond. Respond by cold water on the face gently and/or gentle pressure over the eyes with a cold rag. Push with your knuckle on the acupuncture emergency spot above their upper lip in the cleft under their nose (note, the point is on the bone so therefore push hard to apply pressure to the bone). Lie the client down, and be cautious that they do not stand up too fast. Reduce stress and wait for ten minutes. It will most likely pass. Do not let them leave until they are better.

Call 911 if they pass out for more than a minute, have pain or vomiting, or anytime your better judgment tells you to call 911. Report the fainting spell to the 911 crew.

© August 2010 – The Quantum Academies