Hand Probes Specifications, Treatable Pathologies and Suggested Treatment Protocols

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1 Page 1 Hand Probes Specifications, Treatable Pathologies and Suggested Treatment Protocols Edition 1 Revision 0 Patent Pending BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

2 Page 2 Introduction The purpose of this document is to provide the practitioner with an understanding of the range of common canine pathologies being treated using K-9 Ultrasound device and general treatment protocols. The use of low frequency ultrasound to treat canine musculoskeletal conditions is still a new and evolving science. Comments and feedback from practitioners using the K-9 Ultrasound are welcomed in order to promote the understanding and advancement of treatment protocols. Please note the suggested treatment protocols are designed specifically for the K-9 Ultrasound device and should not be used for other therapeutic ultrasound devices. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed veterinarian. ATTENTION: For use in animals only ATTENTION: Use only a gel legally marketed in US for ultrasound therapy or diagnosis. The gel shall not contain any saline solution. BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

3 Page 3 Hand Probes Specifications Flat silver hand probe (pulsed emission) total treatment time: 500 hours - traumas of the musculoskeletal system - inflammations and swelling of the musculoskeletal system - drainage of edema and hematoma at early stage Concave silver hand probe (pulsed emission) total treatment time: 500 hours - traumas and inflammations of the musculoskeletal system - features a more focalized ultrasonic wave - concave shape allows better coupling on curved areas Convex silver hand probe (pulsed emission) total treatment time: 500 hours - specifically developed for insertional desmopathies - convex shape allows better coupling on narrow concave areas Flat red hand probe (continuous emission) total treatment time: 500 hours - acute muscle pathologies (strains, contractures, elongations) - chronic muscle pathologies (atrophy and fibrosis) - drainage of hematoma at advanced stage / organized or calcified hematoma Concave red hand probe (continuous emission) total treatment time: 500 hours - specifically developed for the treatment of arthrosis - features a more focalized and powerful ultrasonic wave - concave shape allows better coupling on curved areas Shockwave effect hand probe (pulsed emission) total treatment time: 500 hours - acute muscle and tendon pathologies - chronic muscle and tendon pathologies - tendinous calcifications - joint injuries and traumas - scar tissue softening - severe muscle fibrosis / fibrotic myopathy - stimulation of trigger points for pain relief Each K-9 Ultrasound hand probe comes with a total treatment time of 500 hours (or 30,000 minutes). After the expiration of the 500 hours, hand probes can be refurbished for another 500 hours (if still in good condition). Otherwise a new hand probe must be purchased. Contraindications Do NOT treat the following areas: head and eyes, uterus and testicles, heart area. Treatment should NOT be performed if the dog has any of the following conditions: phlebitis, thrombosis, thrombophlebitis, skin injury, pregnancy, tumors or cancers, prosthesis. We do not recommend the use of K-9 Ultrasound on dogs under 11 Lbs / 5 KG. BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

4 Page 4 General Treatment Protocols Please note that K-9 Ultrasound treatment must be prescribed by a licensed veterinarian after a full orthopedic and neurological check. An appropriate K-9 Ultrasound treatment plan for rehabilitation and recovery is built upon an accurate diagnosis and detailed understanding of the musculoskeletal pathology to treat. Treatment areas should be defined after a proper diagnosis, which can be achieved through palpation, radiography and ultrasonography; also computed tomography (CT), MRI, and nuclear scintigraphy might be beneficial in select pathologies. An accurate diagnosis is important in order to direct ultrasound waves toward the area where they are more needed. Without an accurate diagnosis by a licensed veterinarian about the pathology and areas to treat, the outcomes of the K-9 Ultrasound treatment may not be satisfactory. Make sure that the patient does not suffer from any of the conditions reported in section Contraindications on previous page. The safety of the practitioner, patient and equipment should be considered at all times. It is very important to properly prepare canine patients for K-9 Ultrasound treatment, including the prevention of uncontrolled biting, distress or pain. Most veterinarians use some form of restraint to ensure the safety of the individuals and device. Before starting the treatment we suggest to define the area to treat. When defining the area you need to take into account the treatment duration and the extension of the area to treat. Please keep in mind that in 20 minutes you will be able to properly treat a surface area equal to a letter size piece of paper (8.5 x 11 ). Therefore for larger areas you need to adjust treatment time accordingly. Always clean the area to be treat. Unless dog hair is very long, shaving the area to treat is not necessary. Use a spray bottle or a sponge and soak with water the area you want to treat. Spread some gel specific for ultrasound use on the hand probe surface and on the area to treat; repeat the procedure during treatment in order to help ultrasound penetration and the hand probe smooth sliding on the area to treat. By default K-9 Ultrasound is set to start each treatment with a 10% power output and with a 20 minutes treatment time. It is a good rule to start each treatment with the default power output (i.e. 10%) so that the dog can get used to it, and after a minute or so raise the power output to the desired value. Treatment is to be performed by massaging the areas to treat with the hand probe transducers in direct contact with dog hair. Slide the hand probe while applying some pressure on it, using both circular and linear movements. Always move the hand probe, never keep the hand probe still on one spot. The slower you move the hand probe, the deeper the ultrasound effects. The faster you move the hand probe, the more superficial the ultrasound effects. More pressure on the hand probe equals to deeper ultrasound effects. Less pressure on the hand probe equals to more superficial ultrasound effects. Flat hand probes were conceived to treat flat areas, while concave hand probes were conceived to treat smaller rounded areas, since the concave shape allows better coupling on rounded surfaces. In any case you should always try to have the best possible adhesion between the hand probe and the area to treat, since air does not allow ultrasound propagation: this is the reason why you need to make sure there is always plenty of gel between the hand probe and dog hair. BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

5 Page 5 Concave hand probes have deeper and more powerful effects than flat hand probes (providing they are all set at the same power output, moved at the same speed and applied with the same pressure), because of the concave shape of the transducers, which focalizes the ultrasound beam. Red hand probes (continuous emission) were conceived to treat pathologies where the use of heat is particularly indicated, while Silver hand probes (pulsed emission) were conceived to treat pathologies where heat is undesirable. As a general rule, treatments of muscular pathologies should be performed on alternate days; treatments of joint pathologies should be performed either on alternate days or once every three days (depending on the type and severity of the pathology to treat); treatments of calcifications should be performed once every three/five days. It is important to wait between one treatment and the other to allow time for the dog body to perform its own repair processes, which have been stimulated by the ultrasound treatment. Please note that while two hand probes can be permanently connected to the device, the equipment allows the use of just one hand probe at a time. In short 1. identify areas to treat after diagnosis by licensed veterinarian 2. prepare canine patients for K-9 Ultrasound treatment (prevention of uncontrolled biting, distress or pain) 3. clean the area to treat and soak it with water using a spray bottle or a sponge 4. apply ultrasound gel on the treatment area and directly on the hand probe 5. set treatment time and start treatment with default power output 6. after a minute or so raise the power output to the desired value 7. massage the areas to be treated with the hand probe transducers in direct contact with dog hair 8. slide the hand probe while applying some pressure on it, using both circular and linear movements 9. make sure there is always gel between the hand probe and dog hair, until treatment time comes to an end BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

6 Page 6 Dog sizes In the protocols on the next pages we have differentiated suggested treatments based on different dog sizes. Please refer to the following table to determine if your patient falls in the SMALL, MEDIUM or LARGE categories. SIZE WEIGHT RANGE SMALL 11 Lbs - 22 Lbs / 5 KG - 10 KG MEDIUM 23 Lbs - 55 Lbs / 11 KG - 25 KG LARGE 56 Lbs - up / 26 KG - up We do not recommend the use of K-9 Ultrasound on dogs under 11 Lbs / 5 KG. Please note that the following protocols should be used as general indications for use. Power output, treatment time and treatment frequency can be changed according to the severity of the pathologies to treat and to the subjective response of the patient. BAC - USA Phone North US 1 - Suite 402 Fax Ormond Beach, FL USA

7 Page 7 Treatable Pathologies and Suggested Treatment Protocols S O F T T I S S U E I N J U R I E S PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Muscle contractures (e.g. infraspinatus contractures, quadriceps contractures, semitendinosus and gracilis contractures ) FLAT RED / CONCAVE RED (depending on the shape of the surface to treat) % 60-70% 70-90% 20 minutes for an area equal to a letter size page (8.5 x 11 ), otherwise adjust treatment time accordingly. Alternate days, until resolved. Chronic muscle pathologies (atrophy, fibrosis, fibrotic myopathy, bicipital tenosynovitis) SHOCKWAVE EFFECT directly on adhesion (internal scar tissue) or on scar tissue causing the pathology only if adhesion / scar tissue is present. FLAT RED / CONCAVE RED (depending on the shape of the surface to treat) both if adhesion / scar tissue is present or not % 50-70% 60-80% 40-50% 60-80% 70-90% 5/7 minutes directly on adhesion / scar tissue. 8/10 minutes on adhesion / scar tissue and on surrounding areas. Alternate days, until resolved or 2/3 weeks maximum.

8 Page 8 PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Tendon injuries / tendinitis SHOCKWAVE EFFECT on tendon structure % 40-60% 50-80% 8/10 minutes FLAT SILVER / CONCAVE SILVER (depending on the shape of the surface to treat) on tendon structure as well as on surrounding areas % 60-70% 70-80% 8/10 minutes 2/3 times a week, 3/4 weeks maximum. SHOCKWAVE EFFECT on tendon structure % 50-60% 60-70% 8/10 minutes Tendon calcifications FLAT SILVER / CONCAVE SILVER (depending on the shape of the surface to treat) on tendon structure as well as on surrounding areas % 60-70% 70-80% 5/10 minutes Twice a week, until resolved or for 3/4 weeks maximum. Ligament injuries / desmitis and ligament inflammations (e.g. ligament inflammations after tibial plateau leveling osteotomy / TPLO surgery) SHOCKWAVE EFFECT on ligament structure. FLAT SILVER / CONCAVE SILVER (depending on the shape of the surface to treat) on ligament structure as well as on surrounding areas % 40-60% 60-70% 8/10 minutes 40-50% 60-70% 70-80% 8/10 minutes 2/3 times a week, 3/4 weeks maximum.

9 Page 9 PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Insertional desmopathies FLAT RED. Skip this phase if after the first 2-3 treatment sessions dog shows discomfort % 50-70% 70-90% 5 minutes CONVEX SILVER directly on affected area % 40-60% 60-80% 5 minutes FLAT SILVER on area to treat and on surrounding areas 40-60% 50-70% 70-90% 5 minutes Alternate days for the first week. Twice a week for the second and third week. One last treatment during the fourth week. Bursitis FLAT SILVER / CONCAVE SILVER (depending on the shape of the surface to treat) % 50-70% 60-80% 10/15 minutes Twice a week, 2 weeks maximum. Edema FLAT SILVER / CONCAVE SILVER (depending on the shape of the surface to treat) % 60-80% 70-90% 7/10 minutes directly on edema and 5 minutes on surrounding areas to help draining. 3 times a week, 2 weeks maximum. Hematoma at advanced stage / organized or calcified hematoma Scar tissue softening SHOCKWAVE EFFECT directly on hematoma % 40-70% 50-80% 5 minutes FLAT RED / CONCAVE RED (depending on the shape of the surface to treat) both directly on the hematoma and on the surrounding areas to help draining. SHOCKWAVE EFFECT directly on scar tissue % FLAT RED / CONCAVE RED (depending on the shape of the surface to treat) % 60-80% 70-90% 10/15 minutes 40-60% 50-70% 5/7 minutes 30-50% 50-70% 60-80% 7/10 minutes 2/3 times a week, 2/3 weeks maximum. Alternate days, until resolved or for 2 weeks maximum.

10 Page 10 B O N E P A T H O L O G I E S PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Sesamoid bone injury and inflammation SHOCKWAVE EFFECT or FLAT SILVER directly on area to treat % 50-70% 60-80% 15/20 minutes 2/3 times a week, 3 weeks maximum. Arthrosis (e.g. arthrosis caused by hip dysplasia and arthrosis caused by elbow dysplasia) CONCAVE RED 30-50% 50-70% 60-80% 10/15 minutes 3 times a week, 4 weeks maximum. Osteoarthritis / DJD / Medial Shoulder Instability (MSI) / Osteochondritis Dissecans (OCD) CONCAVE RED on area to treat and on surrounding areas. SHOCKWAVE EFFECT directly on area to treat % CONCAVE SILVER on area to treat and on surrounding areas % 60-70% 70-80% 7-10 minutes 70-80% 80-90% 50-60% 70-80% 80-90% 5/8 minutes 5 minutes Alternate days for the first week. Twice a week for the second and third week. One last treatment during the fourth week. Microfractures FLAT SILVER / CONCAVE SILVER / SHOCKWAVE EFFECT (depending on the shape of the surface to treat) % 50-70% 60-80% 10/15 minutes Twice a week, 4 weeks maximum.

11 Page 11 PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Kissing spines FLAT RED on area to treat 50-60% 70-80% 80-90% 5 minutes SHOCKWAVE EFFECT directly on kissing spines 40-60% 50-70% 60-80% 3/5 minutes FLAT RED on area to treat and surrounding areas 50-60% 70-80% 80-90% 5/7 minutes Alternate days for the first week. Twice a week for the second week. Once a week for the third and fourth week. Osteoarthritis of facet joints in lumbar region FLAT RED 40-60% 60-80% 70-90% 7/10 minutes FLAT SILVER 40-60% 60-80% 70-90% 7/10 minutes Alternate days, until resolved or for 3 weeks maximum.

12 Page 12 O T H E R T R E A T M E N T S PATHOLOGY HAND PROBE SMALL MEDIUM LARGE TREATMENT TIME FREQUENCY Stimulation of trigger points for pain relief Apply SHOCKWAVE EFFECT hand probe directly on the 4/5 trigger points you selected to treat. Pressure applied should change according to trigger point depth: the deeper the more pressure you need to apply % 50-80% 60-90% Hold and press hand probe on the first trigger point for 5/7 seconds. Then do the same for the other ones. When finished, restart with the first one and re-do the whole sequence for 10 times total. When needed, not more than once a day. Pre-competition warm-up FLAT RED. Massage the dog s back muscles. Make sure to massage both sides for the same amount of time % 50-70% 60-80% 8/12 minutes per side When needed, not more than once a day. Post-competition cool down FLAT RED. Massage the dog s back muscles. Make sure to massage both sides for the same amount of time % 50-70% 60-80% 8/12 minutes per side When needed, not more than once a day.

13 Page 13 Sales Terms and Conditions Terms Buyer and BAC USA agree that K-9 Ultrasound equipment s sale shall be governed and controlled by these Sales Terms and Conditions. All terms, conditions and prices are subject to change without notice. All payments shall be due and payable in accordance with the payment terms set forth in the Sales Agreement. Costs of collection agency fees, legal fees, interest and service charges will be added to all unpaid invoices if litigation is necessary for collection. Freight charges will be added to each order. All amounts payable are exclusive of any applicable federal, state or local sales taxes and Buyer agrees to be responsible for the payment of such taxes or to assist BAC USA in the collection and remittance of any taxes. Please note that all orders are shipped as Signature Required. All merchandise must be inspected after delivery and any discrepancies, defects or shortages must be reported to BAC USA no later than 48 hours after delivery. Buyer responsibilities At all times Buyer/User shall be responsible for all aspects of canine patient treatment and care, including, without limitation: (a) diagnosis of canine patients and prescription of K-9 Ultrasound treatment; (b) obtaining any required informed consent from dog owners or guardians; (c) preparation of canine patients for K-9 Ultrasound treatment, including the prevention of uncontrolled biting, distress or pain; (d) provision of trained and qualified personnel to operate K-9 Ultrasound device and provide proper care to the canine patient. Buyer/User acknowledges that K-9 Ultrasound device and hand probes are sophisticated electronic equipment emitting low frequency ultrasound waves. If K-9 Ultrasound device and hand probes are not properly used, severe injury and/or property damage can occur. Buyer/User is fully responsible that K-9 Ultrasound device and hand probes are used in a safe and proper manner, according to BAC USA indications for use. K-9 Ultrasound device and hand probes shall be used by trained and licensed individuals. Buyer/User shall assume all legal, personal/patient injury risk and liability and all other obligations and risks associated therewith. Buyer/User specifically acknowledges and agrees that K-9 Ultrasound device and hand probes are not approved by FDA for use in the treatment of humans and are only to be used in connection with veterinary medical practice. Warranty The purchase of K-9 Ultrasound device and hand probes implies full acceptance of these general conditions by the Buyer/User. If the equipment is sold by an authorized distributor, Buyer/User should refer to the distributor s general warranty conditions. Please note that BAC USA will honor only these Sales Terms and Conditions and not the distributor s conditions. Warranty period starts from delivery date. BAC USA guarantees this equipment against manufacturing and material defects. The device warranty is valid for a period of 24 months. Hand probes are guaranteed only for the treatment hours assigned by the manufacturer to each hand probe. After 24 months from the hand probe purchase date the hand probe warranty will expire anyway, regardless of the amount of treatment hours still available. During this period BAC USA will replace or repair for free any defective components, without having to replace the whole equipment. Device downtimes due to parts replacement or repair do not extend the 24 months warranty period. Shipping costs to send the equipment or the replacement parts to and from the assistance laboratories are not covered by this warranty. Replaced defective parts become manufacturer s property. The customer has to give the manufacturer the necessary time and means to perform repair and delivery of replacement parts; otherwise the manufacturer will be exempted from any warranty obligation. BAC USA is not to be held responsible if the device is used by unqualified personnel or for improper use of the equipment. In case of disputes, the only competent courts will be the ones in the manufacturer s area. BAC USA specifically makes no guarantees regarding the effectiveness of veterinary treatments performed with K-9 Ultrasound device and hand probes. Warranty limitation and exemption of responsibility If during or after the warranty period the general warranty conditions are not observed, BAC USA will be exempted from any responsibility in case of damages connected to the items delivered. BAC USA will not be responsible for any material damages or bodily injuries occurred if the equipment has been installed in non-compliance with the laws or regulations of your country, after an operation not specified in the manufacturer s user guide and/or performed by unqualified personnel. Warranty is voided in the following cases: (a) if user manual instructions are not observed; (b) if the device is not maintained or cleaned properly; (c) if the device is connected to a defective or not grounded electrical line or to a line with a different tension from the one indicated on the equipment s label; (d) if you use other hand probes than the ones supplied by BAC USA; (e) if you use other external power supplies than the one supplied by BAC USA; (f) if you break warranty seals; (g) if unauthorized technicians attempt to repair, recover or modify the system; (h) if the device or hand probes are accidentally damaged by operators or patients. If your device is not working properly and needs warranty service, please contact immediately BAC USA or your authorized distributor. Proprietary rights Buyer acknowledges and agrees that all content and materials made available by BAC USA, such as photos, designs, images, text, instructions, downloads, names and logos are the exclusive property of BAC USA and are protected by United States and International intellectual property laws. Buyer may use, display and print content and materials made available by BAC USA for noncommercial and personal use only. Buyer agrees not to reproduce or modify any content or materials made available by BAC USA.

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