New A9a System User Instruction Manual Manual rev: 2014-08 For assistance please contact: Innovative Health Concepts LLC Chicago, Illinois, USA www.allevawave.com Table of Contents User Assistance Information .................................................................... 2 Warnings and Precautions ...................................................................... 2 Purpose of the A9a System ..................................................................... 2 Description of the A9a System ................................................................. 3 Environmental Conditions that Affect Use .................................................... 4 System Setup ...................................................................................... 5 Operating Instructions ........................................................................... 6 Coil Placement Examples ........................................................................ 9 Frequency and Duration of Use ............................................................. ...10 Cleaning and Maintenance ................................................................... .. 10 Servicing ........................................................................................ .. 10 Storage .......................................................................................... .. 10 FAQ .............................................................................................. .. 11 Recommendations…………………………………………………………………………………………………………………….13 Expected Battery Life ......................................................................... .. 14 www.allevawave.com 1 of 14 A9a User Instruction Manual User Assistance Information If you have questions or require assistance you may contact us at: Innovative Health Concepts LLC Chicago, Illinois, USA www.allevawave.com [email protected] Warnings and Precautions Meanings of Warnings, Cautions and Notes This manual contains specific warnings, cautions and notes which you should read and follow carefully. They are displayed as shown below and have the following meanings: WARNING If a specific action or procedure is not followed, you may suffer personal injury or the device may be damaged. Caution If a specific action or procedure is not followed, the device may be damaged. Note If a specific action or procedure is not followed, the device may not function properly. General Precautions This device emits electromagnetic energy by design. This type of energy goes by various names, including RF energy, radio frequency energy, EMF, EMP PEMF, ICES and various other designations. It is a very low power device. The average power output is approximately 1/3 watt, which is much less than the power output of a cellular telephone. All of this energy first passes through the upper green LED, which then charges the system for each pulse. The total system generates only as much power as you can visually see illuminating the upper green LED. You should not use the device on or around the brain, ears, and eyes, unless you are under specific instructions from a medical professional. If you are pregnant you should not use the device near the fetus. If you feel pain during the use of the device you should stop using it and consult your physician. If you experience increased pain or discomfort, you should consider using a lower power setting if available, changing the location of the coils, or discontinuing use of the device altogether if the problem persists. If the application of ICES seems to make your problem worse, we recommend that you immediately discontinue use of the device, and promptly talk to your physician. There is no valid scientific reason to believe it is harmful to use this device. However, if you have concerns about exposure to electromagnetic energy you must not use this device. WARNING You should not use this device near the brain, ears and eyes. You should not use the device near the fetus if you are pregnant. If you feel pain while using the device you should stop using it and consult your physician. And if you have concerns about exposure to electromagnetic energy then you must not use the device. Purpose of the Alleva-Wave™ A9a System The Micro-Pulse Alleva-Wave ™system is intended to safely assist in recovery from injury or damage in hard and soft tissue, and to reduce or eliminate swelling and pain in most tissues. This includes bones, tendons, ligaments, muscles, and cartilage. The AllevaWave system operates by applying a precisely controlled pulsed electro-magnetic field (PEMF )and inducing an electrical pulse . The pulsed electromagnetic fields operate at a cellular level to promote repair and regeneration of structural tissues; it is because of this cellular level action that the (ICES) system can positively affect such a wide range of tissue types. www.allevawave.com 2 of 14 A9a User Instruction Manual More specifically, the Alleva-Wave™ (ICES) Inductively Coupled Electrical Stimulation can be used to accelerate tissue recovery following surgical procedures, promote faster tissue recovery following injuries (from sports, daily activities, work, etc.), and reduce chronic swelling in tissues. An important application is the reduction of joint pain, whether chronic or from injury. Description of the Alleva-Wave™ A9a System System Components The A9a system has the following major components: 1 Pulse generator Creates precisely controlled electrical pulses that power the coils. 2 9-volt battery Supplies power to the pulse generator. Any type of 9v will work 3 Coils Transmits electromagnetic pulses into the tissue being stimulated. Each of the two coils has a bumpy side and a smooth side, for easy orientation. 4 1 2 Battery charger (not shown) optional Recharges the 9-volt battery when the battery is not being used in the pulse generator. Pulse Generator Details The pulse generator has the following components. Many of these are explained in more detail in the following manual sections: 1 Connector for coils Receives the plug for the cabling to the coils. 2 2 Upper green LED 1 Indicates the system is generating pulses in Stimulation Mode during 3 operation. 2 Lower red LED Indicates there is a problem with the system that is not serviceable by the user. 4 3 Cycle profile switch Allows you to select from among four cycle profiles, which define how the pulse generator outputs the stimulation pulses. The cycle profiles are indicated by L M H X L= very low intensity setting 70 Tesla/S, small animals, sensitive subjects M = standard intensity fields are generated, 100 Tesla/S, suggested initial treatment protocol. Same as setting 1 on earlier models. H = higher intensity fields are generated, 160 Tesla/S, for deep tissue injuries X = 35% higher intensity fields are generated continuously, 200+ Tesla/S. Higher than setting 3 for older model For experienced users only, 500 milliwatts of electro-magnetic energy in RF spectrum. 4 Socket for 9-volt battery with polarity indicators Holds the 9-volt battery. The positive (+) and negative (-) polarity markings on the socket indicate how to insert the battery to properly align its positive and negative terminals. Unit starts upon insertion. www.allevawave.com 3 of 14 A9a User Instruction Manual Theory of Operation Pulse generator The Alleva-Wave ™ ICES system promotes tissue recovery through the application of precisely generated magnetic and electrical stimulation pulses which are created by the pulse generator. The stimulation pulses are designed with proprietary combinations of frequencies, amplitudes, field directions, and wave shapes to activate tissue recovery at a cellular level Four levels of ICES magnetic field intensity The Alleva-Wave™ can generate either Low intensity magnetic fields for very mild or sensitive tissue stimulation, or M standard intensity fields for mild ,standard tissue stimulation. You can move the cycle profile switch to position H to generate vigorous intensity fields for deep tissue injuries and stimulation or you can select position X to generate 35% higher intensity fields. When first using the Alleva-Wave ™it is recommended that you set the cycle profile to M (standard intensity) on the first day or two as you become familiar with the device. Thereafter you can select cycle profile H (higher intensity) or X (higher intensity, only experienced users). *only use when clear lower settings not effective, Do not try to accelerate healing by applying excessive power. Higher intensity fields are recommended when the injured tissue is far from the coils. It is also recommended after you feel comfortable with low intensity fields and you feel that more stimulation intensity would be beneficial for your tissue. Cycle profile switch The Alleva-Wave™ A9a operates on about a 40 minute cycle that repeats continuously and automatically. Using the cycle profile switch, you can select from among four predefined cycle profiles. Switch Magnetic Mode for position field intensity Operation L M Low Standard Stimulation (flashing green) Stimulation (flashing green) H Higher Stimulation (flashing green) X Higher Stimulation (flashing green) LED indicators The LED's indicate various conditions and activities: All LED's are OFF = battery is dead or removed Upper green LED is flashing = system is operating and is in Stimulation Mode Lower red LED is flashing = system has a malfunction, requiring you to contact the supplier Coils The ICES pulses are transmitted into the tissue between or adjacent to the two coils. Having two coils provides flexibility in shaping and directing the magnetic fields. Configuring the coils properly is described later in this manual. During stimulation you may hear a high-frequency clicking sound coming from the coils. This is normal and is caused by the rapid change of the magnetic field produced by the coils. Listening for the clicking sound is a good way to assure the system is working properly. Environmental Conditions that Affect Use The Alleva-Wave™ ICES system can be used during most normal daily activities. However, it cannot be used or worn when bathing, swimming or during any activity that would expose the device to a wet environment. Do not submerge the device in water or any liquid. Caution Do not expose the Alleva-Wave™ A9a system to a wet environment, or submerge the A9a system under water, or clean the device using water. Doing so may permanently damage its electronics www.allevawave.com 4 of 14 A9a User Instructions Connect the Coils Plug the coils into the pulse generator. Be sure to always connect and disconnect the coils with a battery removed. Do not remove coils while unit is in operation. This is to avoid possible damage to the internal electronics. Caution Always remove battery before inserting or removing the coil connector. This will prevent possible damage to the pulse generator electronics. From the very first use of this system the coils should always remain plugged into the pulse generator and should never be unplugged during use. Unplug the coils only when they need to be replaced. Though it is unlikely, the system can be damaged if it is operated with a partially-inserted coil plug, or if the plug is removed during operation. Insert the Battery The battery bay has a spring loaded quick-connect mechanism to make it easy to insert and remove batteries during operation. This allows you to keep the system in place while changing batteries. No tools are needed to change batteries. The system will operate as long as the battery remains inserted, until the battery is fully drained. You can use any standard 9-volt battery. Either non-rechargeable batteries (typically Alkaline) or rechargeable batteries (Lithium or NiMH) can be used. 7.2/8.4/9.6 volts. It is recommended to use rechargeable batteries to minimize your operating cost. A very common approach is to have two rechargeable batteries and a quick-charging battery charger. This allows you to use the Alleva-Wave ™system with one battery while the other charges, so that you can switch between the two batteries for continuous stimulation. Insert a fully charged battery into the pulse generator. Confirm that its terminals are correctly aligned to the positive (+) and negative (-) markings on the pulse generator. Unit will NOT operate if battery is inserted in reversed polarity. A rechargeable NiMH battery will normally last four to eight hours during operation. For more detailed battery life information please refer to the "Expected Battery Life" section of this manual. It is okay to run the Alleva-Wave ™system until the battery is completely drained. Simply recharge or replace the battery to continue stimulation. WARNING Do not charge Alkaline and other types of non-rechargeable batteries. They can explode and cause injury. Check the System Before using the Alleva-Wave ™A9a ICES system you should: 1) Ensure the connector for the coils is completely inserted into the pulse generator. 2) Inspect the coils and the cabling to ensure there are no exposed or broken wires. 3) Ensure the pulse generator has power from the 9-volt battery. Do this by moving the cycle profile switch to position L, M or H. Then the upper green LED should begin flashing, which indicates the system is operating in Stimulation Mode. If there is no LED activity or if the LED's are dim, then the battery is drained and needs to be recharged or replaced. Red LED indicates system failure. Contact manufacturer. www.allevawave.com 5 of 14 A9a User Instruction Manual Operating Instructions Record the Injury or Pain History It is very useful to put into writing the history and progression of the injury or pain before using the Alleva-Wave™ ICES system and then record your response throughout the stimulation period. Keeping a written record will help you objectively monitor your pets progress and make better decisions regarding coil placement strategies (explained later in this section). Understand Coil Configurations and Stimulation Zones The Alleva-Wave™ ICES system has two specially- designed coils. The two coils allow you to control how the pulsed magnetic field is shaped into different stimulation zones so that you can better focus the ICES on the injury site. This maximizes the stimulation to the injured tissue while minimizing unnecessary stimulation to surrounding tissues. This ability to control stimulation zones is a unique advantage of the A9a system. In addition, each coil is flexible to allow you to bend and shape the coils to conform them to the surface of the body, limb, neck, face, jaw, digits, or whatever area is being stimulated. The two coils are always placed with the bumpy side away from the skin. They are positioned in one of two basic configurations depending on the area of the body to be stimulated: Opposite-Side - The Opposite- Side configuration is generally used to stimulate thinner body sections and joints, such as arms, elbows, knees, ankles, etc. In such cases the two coils are located on opposite sides of the injured or painful tissue. The Opposite-Side configuration is preferred over Side-by-Side when possible, as it produces stronger and better focused electromagnetic fields in the tissue being stimulated. Side-by- Side - The Side-by-Side configuration can be effective for large, thick parts of the body when the injury is relatively close to the surface, within 1 to 2 inches (25 to 50 mm) of the skin. In these cases the coils are situated on the same side of the injury area, adjacent to each other. The coil configurations result in the two different stimulation zones illustrated below. The darker regions of the stimulation zones indicate where the magnetic fields are strongest. The stimulation zone of the opposite-side coil configuration is narrower and deeper, whereas the stimulation zone of the side-by-side configuration is wider and more shallow. ICE Stimulation Zone of the Opposite-Side Configuration ICE Stimulation Zone of the Side-by-Side Configuration www.Alleva-Wave.com 6 of 14 A9a User Instruction Manual Sometimes it may not be obvious which configuration should be used. For example, a shoulder injury might best be stimulated with the Opposite-Side configuration or the Side-by-Side. Or, it may be stimulated by alternating between the two configurations. You are encouraged to experiment with configurations and coil placements to determine which works best for you. The coils can also be stacked with bumps facing bumps to focus wave on single injury point similar to acupuncture or laser treatment. Place the Coils in Position The orientation of the coils to each other and to the injury is important for optimal benefit from the ICES fields. There are three guidelines when locating the coils on the body: 1) Put the bumpy side out of each coil, away from the skin 2) Place the coils as close together as possible (Side-by-Side configuration) 3) Position the coils so the injured tissue is between the coils (Opposite-Side configuration) 4 ) Stacked with bumps facing each other. Note Follow the three coil placement guidelines to make sure you are receiving the full benefit from the magnetic fields. Visualizing the ICES field can be helpful when considering how to place the coils. When the coils are placed in an Opposite-Side configuration, they will generate a magnetic/electrical field that fills the space between them. The closer together you place the coils, the stronger the field will be, and the more stimulation you will be able to focus onto the injured tissue. When the coils are placed in a Side-by-Side configuration, they will generate a ICES field that is wider across the area. The closer the two adjacent coils are, the stronger the field will be. It is therefore recommended that the coils touch each other in the Side-by-Side configuration. As stated in the guidelines, place the bumpy side of each coil away from the skin. This applies to both the Opposite-Side and Sideby-Side configurations. This ensures the ICES fields are lined up properly. If the bumpy sides are not out, then the ICES fields may oppose and cancel one another, and will render the system ineffective. It is okay if the wound is larger than can be completely covered by the coils. The stimulation has a beneficial effect on tissues in the general area of stimulation, so coil placements do not need to be precise. It may also be helpful to move and reposition the coils occasionally, especially if the exact site of the injury is not clear. Repositioning will change the orientation of the magnetic field, which is often beneficial in the recovery process. For example, on the first day or two you might place the coils on a limb on the lateral (outside) and medial (inside) surfaces. Then for the following day or two you might choose to reposition the coils on the dorsal (back) and ventral (front) surfaces around the injury. You might later decide to place them obliquely (at an angle). The coils can be stacked (bumpy side to bumpy with smooth side against skin) this stacked configuration is used when the location of an injury is pinpointed. This type of treatment is similar to acupuncture, where the needle is precisely located on known meridians for pain erasure. To the extent possible, it is best to try several options to determine what seems to work best. The preferred placement of the coils might ultimately be driven mainly by practical concerns such as ease of securing or bandaging the coils or placement of the pulse generator. You should not use the device on or around the brain, ears, and eyes, unless you are under specific instructions from a medical professional. WARNING Do not use the Alleva-Wave™ on or around the brain, ears, and eyes unless under specific instructions from a medical professional. Always use on low setting if advised. www.allevawave.com 7 of 14 A9a User Instruction Manual Secure the Coils and the Pulse Generator The two coils are normally placed directly against the skin and secured in place using adhesive medical tape or medical bandages. Loose clothing can be worn over the coils, if their location permits. Alternatively, the coils can be located outside the wraps and fixed in place using tape or elastic bands. In this case the wraps and coils at the location should be held close to the skin for maximum magnetic field penetration into the injured area. The ICES fields will penetrate clothing, tape, bandages, leather and other nonmetallic materials with no problems. However, the magnetic fields can be distorted or weakened by the presence of metallic objects. These can include watches, metal zippers, belt buckles, coins, cell phones, and other electronic devices. You should keep metallic objects at least 8 inches (200 mm) away from the coils. Note Keep metallic objects at least 8 inches (200 mm) away from the coils to ensure the magnetic fields are properly focused. The pulse generator can similarly be secured by adhesive medical tape or medical bandages. It can also be placed in a pocket if one is available. Some users fashion a special simple garment with extra pockets or pouches to hold the coils and pulse generator in position during stimulation, for example, using an old t-shirt and iron-on pockets or stitched-on pouches. This works well because each individual case is different. Coil Life and Coil Test Chip The Alleva-Wave coils are very durable but they tend to see a lot of mechanical wear and tear depending on amount of use. It is possible that due to continuous daily usage, customers should expect to have to replace coils about once per month (675-1500 hrs). The average user will get 3 to 6 months of use out of their coils, but you have to keep in mind the coils are like a toothbrush: more use = shorter life expectancy. We provide 2 sets of coils with each new unit order at no extra cost, to provide a backup so that no interruption of treatment exists. We suggest you should reorder and replace worn out coils immediately. If you can hear the coils clicking, they are working. Also avoid any cross contamination by avoiding sharing coils between animals. The coil test chip can also be used to visually verify that the coils are properly working. Simply place the coil over the tester chip. If the coil test chip’s LED blinks green, then the coil is operational. Monitor the Pulse Generator LED's As you use the Alleva-Wave™, occasionally look at its upper green LED is blinking. If the upper green LED is flashing then the A9a is in Stimulation Mode during its cycle. If the LED is not lit then likely the battery is drained. Occasionally Change Coil Locations One very good strategy is to occasionally change the placement of the coils. This helps direct the ICES fields in different directions toward the injured area, and thus aids the recovery process. Changing coil locations regularly works particularly well on long-term programs. For example, for lower back stimulation you might change the positions of the coils on your back several times during the day, assuming they are in a Side-by-Side configuration. Then every two or three days switch from the Side-by -Side configuration to an Opposite-Side configuration where one coil is located on the lower abdomen and the other on the lower back (both coils with bumps out). www.allevawave.com 8 of 14 A9a User Instruction Manual You can try many different coil placement strategies to see which ones work best for you. Changing coil locations, and therefore changing the tissue stimulation pattern, is similar to occasionally changing the way you exercise. In both cases your body experiences longer term health gains as it's subjected to a variety of different external stimulations. Another reason to change coil locations is the effect of "accommodation", where tissues of the body often learn to ignore repeated external signals. You can see this in many ways. One way is where certain exercises or workouts that used to work well no longer seem to give the same benefit. Another is where pain drugs can have slightly less effectiveness through repeated use. And still another is where very spicy foods that once were intolerable can taste good after building resistance to their chemical burn. In the same way body tissues over time will tend to accommodate the Alleva-Wave’s™ Inductively Coupled Electrical Stimulation (ICES)- if it is kept the same - and will therefore reduce the effectiveness of the stimulation. To reduce this accommodation effect the brain and nervous system need to be kept "guessing" by periodically changing the PEMF stimulation orientation. You are encouraged to try different coil location and configuration strategies to reduce the effects of tissue accommodation. Remove Battery When Done Please remove the battery when you are not using the Alleva-Wave™. This helps to preserve battery energy. If a rechargeable 9volt battery is being used and if it is drained, then it can be placed in an appropriate battery charger in preparation for next use. It is advised to remove battery when not in use to avoid battery drain. Unit will continue to operate with charged battery inserted. Continue Recording the Injury or Pain Response As you progress through the stimulations continue to keep a daily written record of your response. This will help you make adjustments to coil placement locations and assist you in monitoring your progress. Coil Placement Examples Below are examples of how coils can be located on different parts of the body in either Side-by-Side or Opposite -Side configurations. Two or more coil placement alternatives are shown for each injury area below to emphasize the importance of periodically moving the coils into different orientations. Many other areas of the body can be stimulated with the Alleva-Wave™ system beyond those shown. The illustrations below show the coils in their "flat" geometry. However, you are encouraged to flex and shape the coils to your pets’ body contours for both comfort and greater stimulation effectiveness. Please Note: DO NOT use any type of creams, liniments, oils etc. with the coils. It may cause irritations. It is also not recommended to treat multiple horses or pets with the same set of coils. This will avoid any cross contamination. Additional coils are available for purchase. www.allevawave.com 9 of 14 A9a User Instruction Manual Frequency and Duration of Use The frequency and duration of use varies with the person and situation. A first time user with a mild injury or mild symptoms might use the Alleva-Wave™ only once per day for 4 hours at a standard stimulation intensity setting, for example, setting M. A more experienced user with a more severe injury or severe symptoms might use the device 2 or 3 times each day for 4 to 6 hours each time at a higher stimulation setting. Between these two extremes there are many possible regimens you can experiment with. A very typical regimen is 6 to 8 hours per day, either during the day or while sleeping at night. Rest periods are as important as stimulation periods, to allow tissues to recover. Simply not using the device for certain periods of time are advised. Each person's daily pattern of use will be unique to their injury or symptom, their daily routine, and their response to the stimulation. You are encouraged to experiment with usage patterns and coil locations to find what works best for you. Also, keeping a daily written record of your response will help you make adjustments to usage patterns and coil locations. Output Intensity Coils configuration determines the intensity of the ICES field. Separately, each coil together will produce a specific intensity (for the A9a model, 70 to 90 *Gauss on setting L). When placed near each other (coils next to each other on the back, for example), or opposite each other (one coil on each side of a knee, for example), the intensity increases (for the A9a model, up to 120 Gauss on setting M). Setting H output is up to 180 Gauss. When the coils are stacked (nubby side to nubby side), intensity increases further (for the A9a model, up to 200 Gauss.) Setting X output is consistently in excess of 200+ Gauss regardless of coil configuration. * Gauss is standard measurement of magnetic wave strength. 1 Tesla=10,000 Gauss Cleaning and Maintenance The Alleva-Wave™ system requires very little cleaning. If the coils and cable become dirty with use then you can clean them with common rubbing alcohol (isopropyl alcohol). The Alleva-Wave ™system requires no maintenance or calibration. Servicing The Alleva-Wave ™system has no parts that you can service or repair. If the coils become damaged please contact your supplier for advice on replacement options. www.alleva-wave.com If the lower red LED is flashing, then there is an electrical fault in the device and it will not operate properly. Please contact your supplier for advice on repair and replacement options. Storage When storing the system for more than one month you should remove the 9-volt battery to prevent corrosion. Recharge batteries before using the system again. Caution Do not store the system with the 9-volt battery installed, as this may result in damage to the pulse generator from battery corrosion. The unit will trickle drain a new battery. www.allevawave.com 10 of 14 A9a User Instruction Manual FAQ Q: How do I know if my device is working properly? First, plug in your coils and make sure they are plugged in all the way. Then insert a fresh, fully charged 9-volt battery. Then move the cycle profile switch to either position L, M, H or X. You should see the center LED flash three times, and then see the upper green LED flash as the device operates. Finally, put each coil close to your ear and listen for its "click-click -click" sound. Or test with chip, If you see the green LED flashing and if you hear the clicking sound, then the Alleva-Wave ™system is functioning properly. Q: How will I know when the battery needs charging? The LED's will become dim or will go out entirely, and you will no longer be able to hear the coils clicking. Refer to the "Expected Battery Life" section in this manual to determine the approximate battery life that applies to your battery and usage. Q: Can I use any battery charger to recharge the battery? Any commercial battery charger will work as long as you have rechargeable batteries. Be sure to match rechargeable batteries to the correct type of charger or you could easily damage or destroy your batteries and charger. Almost all types of rechargeable batteries require a different specific charger: NiCad, NiMH, Li-Ion, Li-Polymer, Hybrid, etc.7.2/8.4/9.6 volt will work. Q: The device makes a clicking or humming noise. Is this normal? Yes, this is normal. The device is humming for the same reason that power transformers on telephone poles sometimes hum and vibrate. The phenomenon is known as magnetostriction, and it is normal and harmless. Unfortunately it is an unavoidable side effect of the physical operation of the device. We are working to reduce the noise in future designs but this may not be possible due to the physics of the device operation. When you hear these sounds in most cases it means the device is operating properly. To diminish noise, try covering unit with a towel or wrap. Q: One of the coils does not seem to be working (no clicking sound) but the other one still works. Will the device still be effective? The device will not be as effective with a non-functional coil. Both coils are required for effective stimulation and we recommend that you order replacement coils. Q: I would like to locate the pulse generator farther from the coils when I use the device. Are longer coil cables available? Or can I add an extension cable to the coil cable? We offer 3 lengths of coil cable. 10”,20” & 47”. We do this because the cable length of the Alleva-Wave™ is designed to transmit maximum energy to the coils. Longer cable lengths decrease the transmitted energy due to electrical losses in the cable. If you feel it necessary to add an extension cable, it should conform to the following guidelines: a) cable length: 24 inches (600 mm) or shorter; shorter is better b) cable type: high-performance audio cable; higher quality cable provides better performance c) connector style: 3-conductor audio, 1/8" diameter audio plug and socket d) connector material: gold-plated; wipe contacts clean before first use Depending on various factors, adding an extension cable will create an approximate 20% reduction in magnetic energy at the coils. This will reduce stimulation to the tissue and will reduce the device's effectiveness. Q: If the pulse generator is damaged in any way, is there a chance the device can cause a fire? NEVER use a damaged device. Although the risk of creating fire with the device is very remote, we recommend that you do not take any risks. The units are internally sealed against moisture and tampering, so it is not possible to repair a pulse generator once it has sustained damage. We recommend you contact your reseller to order a replacement unit. www.allevawave.com 11 of 14 A2 User Instruction Manual FAQ continued Q: I dropped the pulse generator in water. What do I need to do? Will it ever work again? There is no guarantee it will work again. However, in some cases, if it is dried quickly and thoroughly enough, it might function again. First, IMMEDIATELY get the pulse generator out of the water and disconnect the battery. Then disconnect the coils. Second, shake the device vigorously to remove any excess water and wipe the exterior dry. Third, put about 0.5 inch (12 mm) of dry white rice in the bottom of a jar or bowl and place the pulse generator on top of the rice. Fourth, seal the top of the jar or bowl, and let sit overnight. The dry rice will absorb moisture in the container, including (hopefully) the water in the pulse generator. Discard the rice after use. If available, it is preferable to use desiccant instead since it will absorb moisture better than rice. DO NOT place the pulse generator in an oven or microwave to dry. Q: Why don't I feel the current when the system is in operation? Will it give me a shock? The Alleva-Wave’s™ output is a magnetic field and inductively coupled electrical field NOT a direct electric current like a TENS unit. The device is very low power. In fact, all of the energy that goes into the magnetic field first passes through the upper green LED, so the total amount of output power is very low, only 1/3 watt. This is much less than the power of a typical cell phone. The voltage and amperage is too low to give a painful shock. A slight tingling may be felt if the coil wires become exposed through damage, but no harm to the skin will result. Q: I feel a tingling sensation when I use the device. Is this normal? Yes, it is a common occurrence and generally does not indicate any type of problem. This happens most often when stimulating tissues where the coils can be placed on opposite sides and very close together, such as across the wrist, hand, ankle, or foot. If the sensation causes discomfort you could try lowering the intensity setting or placing the coils slightly farther apart. Usually this sensation is not unpleasant and after some use it will gradually fade until you no longer notice it. Q: When I use the device it causes the pain to intensify. What should I do? Generally the device should not cause pain or discomfort. If this happens you might try shifting the position of the coils and reducing the intensity setting on the device if possible. If the problem persists for any length of time we strongly recommend that you discontinue use of the device and seek medical advice. Based on our experience this type of reaction often indicates that you need a physician or specialist to take a detailed look at the area with the increased pain. Increased pain indicates a need for close medical attention and advice. Q: How soon should I expect a reduction in pain? Each person's response to the ICES stimulation is different and we cannot guarantee results. However, pain reduction often occurs within the first 3 to 4 days of use, and permanent reduction of pain often occurs within 2 to 3 weeks of correct use. .Q: Does it matter which way the battery or optional 9v adapter is inserted? The proper polarity +/- must be used for the unit to operate with a 9v battery. The optional 9v adapter must also be inserted with the correct polarity prior to being plugged into a wall outlet. Failure to do so could result in a electrical fire or shock and damage to the internal components of the unit. Please Note: DO NOT use any type of creams, liniments, oils etc. with the coils. It may cause irritations. It is also not recommended to treat multiple horses, pets or people with the same set of coils. This will avoid any cross contamination. Additional coils are available for purchase. www.allevawave.com 12 of 14 A9a User Instruction Manual General Recommendations for ICES Setting and Usage L = LOW. This setting is about half the power of the minimum setting (#1) used in earlier ICES models. Nonetheless, the power setting "L" has been demonstrated by independent laboratory testing to be very effective at reducing acute inflammation in controlled laboratory animal testing. RECOMMENDED USE: For very sensitive animals such as horses and very small animals. We recommend beginning any treatment of small or very sensitive animals using the setting "L". The setting may be increased without limit if the animal seems to tolerate the device well and if more powerful stimulation is thought to be likely to be more effective. M = MEDIUM. This setting has equivalent peak power to the original ICES setting #1, but there is no rest period on this or any of the new ICES power settings (L M H and X). RECOMMENDED USE: We recommend beginning all treatments on the setting "M" unless otherwise recommended for the setting "L" above. H = HIGH. This setting has equivalent peak power to the original ICES settings #2 and #3, but there is no rest period on this or any of the new ICES power settings (L M H and X). So the setting "H" is exactly equivalent to the original power setting #3, which also had no rest period. RECOMMENDED USE: For experienced users who have experience with the way injuries respond to ICES technology, it is OK to begin at power setting "H", especially for deep tissue injuries, acute recent and severe injuries, and for injuries that are not responsive to treatment for at least two weeks on a lower setting ("L" or "M"). X = Extra-high power. This setting delivers more power than was available from earlier ICES systems. It delivers about 35% more power than the highest previous setting (#3). RECOMMENDED USE: For experienced users only. Please use this setting only when it is absolutely clear that lower power will not yield acceptable results. Please do not try to accelerate the effects by applying excessive power. On this power setting the ICES system delivers about 500 mW (500 milli-Watts, which is the same as 1/2 Watt) of electro-magnetic energy in the RF spectrum, which is non-ionizing radio-frequency radiation. At that power level, which is equivalent to about half the maximum RF power radiation of a typical cellular phone, there is no reliable data that we are aware of, nor any scientific reason that we know of, to suggest safety concerns. However, we believe it is always good practice to minimize the total exposure to radiated energy in any form. And finally, based upon independent laboratory testing the data clearly indicate that lower power settings cab be very effective at reducing inflammation, with somewhat diminishing returns for higher power settings. We believe it is best to reserve the "X" setting only for immediate use after severe injury, or when lower power settings after careful and prolonged use do not yield adequate relief. GENERAL ADVICE: Reduce the power setting if any discomfort is evident. Discontinue use if discomfort persists or worsens. If symptoms do not improve within the first few days of use, before trying higher power settings try different placements of the coils around and near the injury. Often placing the coils closer to the center of the body than the site of the injury works well, especially for injures involving nerve tissue or the lower spine. Always place the coils correctly: bumps away from the skin. Allow at least three weeks for beneficial effects. Then continue use for a more permanent effect (see below) Replace/recharge batteries as needed. Expected battery life depends mostly upon the power setting (L M H or X). Using a 500 mAh energy capacity Lithium-polymer rechargeable 9 volt battery, the expected battery life between charges is as follows: power setting hours of continuous use L generally more than 24 M about 20-24 H about 10-12 X about 8 hours maximum Don't stop treatment as soon as a benefit is seen. Continue treatment for at least three weeks after symptoms have subsided, or for at least as long a period as was required to get symptomatic relief, whichever is longer, to get the best chance for a permanent improvement. Otherwise symptoms may return after a period of time when use of the ICES system has been prematurely discontinued. www.allevawave.com 13 of 14 A9a User Instruction Manual Expected Battery Life The hours of battery operation you can expect depends on two factors: the battery type and the cycle profile setting selected (1, 2 or 3). Certain makes and types of batteries have more available energy than others. For a given battery, as the cycle profile setting is increased, the expected battery life decreases due to larger power requirements. Tests were run on a sampling of rechargeable and non-rechargeable batteries to give you an idea of the approximate battery life in hours of continuous operation for each switch setting. The results are shown in the summary table below. The table assumes a battery is still "good" if its output power remains at or above 80% of its initial full power value. There are many good batteries available for you to buy and this is not a recommendation for the brands included in this test. Rather, this test data is provided to give you an estimation of the range of operating battery life likely depending on battery type and cycle profile setting. With this data you can estimate the duration and cost of operating the device and therefore select the best battery for your overall needs. Battery Life Estimates Summary Table Hours of operation until battery output drops below 80% full power Setting L Setting M Setting H Setting X + Li-Ion MaxPower 550 mAh 34 24 12 8 + Li-Ion Marsell 350 mAh 24 16 9 4 + NiMH Tenergy 250 mAh 11 6 4 2 + NiMH Tenergy 200 mAh 13 8 7 6 * Alkaline Energizer MAX 30 22 12 6 * Alkaline DuraCell 28 24 12 5 * Alkaline Generic 25 17 10 4 + Rechargeable batteries. Can be used many times. Non-rechargeable batteries. Can be used only once. * Never recharge a non rechargeable battery Alleva-Wave™ is designed and assembled in USA by Micro-Pulse LLC www.pulse-pet.com www.allevawave.com 14 of 14 A2a User Instruction Manual
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