LEGAL

This legal disclaimer ("Disclaimer") applies to the purchase and use of any medical device manufactured or distributed by SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC ("Manufacturer").

1. Authorized Purchasers

Purchases of any medical device from SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC ("Device") are strictly limited to properly licensed medical professionals. By purchasing a Device, the purchaser ("Purchaser") affirms that they are a licensed medical professional with the authority to operate and use such medical equipment in accordance with applicable laws and regulations.

2. Insurance Requirements

The Purchaser is required to maintain proper and adequate medical malpractice insurance and commercial liability insurance at all times during the possession and use of the Device. Proof of such insurance may be requested by the Manufacturer at any time.

3. Prohibited Uses and Warranty Voiding

The use of the Device for any unspecified or off-label purposes is strictly prohibited. Any such use will immediately void the warranty provided by the Manufacturer. The Manufacturer shall not be held liable for any damages, injuries, or other consequences arising from the use of the Device outside of the specified and approved operating parameters as outlined in the product documentation. Any use outside that described in the operating manual will be considered a warranty voiding event. A DROP event after receipt of the unit is a warranty voiding event. Each unit is equipped with DROP sensors and any DROP that is not reported is a warranty voiding event. Use of this unit with out the provided surge protector or use without a surge protector is a warranty voiding event.

4. Release of Liability

By purchasing the Device, the Purchaser releases SHOCKWAVE PRO USA LLC from any and all liability related to the use of the Device outside of any and all listed and specified operating parameters. The Manufacturer is not responsible for any misuse, unauthorized use, or use that is inconsistent with the instructions and guidelines provided with the Device. By purchasing this device the purchaser releases this company and the manufacturer of any and all liability related to injury of a patient during the use of the machine outside of any and all operational instructions and guidelines. Including power to frequency ratio, improper care or maintenance of the machine. It is the purchasers duty to ensure any authorized user utilizing the device has been properly trained and must be supervised by the provider.

5. Instructional Materials

All instructional materials, manuals, and guidelines provided by SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC are assumed to have been read and understood by the Purchaser upon receipt. The Purchaser agrees to strictly adhere to all instructions contained in any material provided by the Manufacturer prior to the delivery and operation of the Device. Failure to follow these instructions may result in injury, damage, or other adverse consequences, for which the Manufacturer disclaims all responsibility, and the purchaser agrees to release SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC pertaining to any use or operation outside the explicit use detailed in any instructions or manuals provided.

6. Acknowledgment

By purchasing and using the Device, the Purchaser acknowledges that they have read and understood this Disclaimer, and agree to abide by all terms and conditions contained herein.

7. CLAIMS MADE
This manufacturer does not claim that this machine can cure any disease or musculoskeletal condition. The manufacturer is a FDA Registered Medical Device Manufacture holding current and up to date Registration Status. This is not to imply that this device has been individually evaluated by the FDA or approved in any way by the FDA. Any claims referenced by the manufacturer referencing specific or general musculoskeletal conditions have not been approved or evaluated by the FDA. Current FDA Policies state that Class I Medical Devices DO NOT require individual FDA Device registration so long as the manufacturer is a Registered FDA Medical Device Manufacturer. Any and all information pertained in any reference text, manual, or information provided is solely for reference purposes and does not in itself constitute medical advice, but rather reference material and educational references for licensed medical providers to be used to determine appropriate courses of care and professional resources to be used in their own professional practices. All medical providers should adhere to all appropriate rules, regulations, and standards of practice for their specific licensure, state and local requirements, and specific boards and appropriate professional standards. It is the responsibility of the individual medical providers to ensure they maintain proper continuing education regarding the use of this technology and appropriate malpractice, liability, professional liability, and any other appropriate insurance specific for their individual fields of practice. Read our full disclosures, claims made, and legal terms at the end of this document. The phrase or terminology "Manufactured In The USA" and "Assembled In The USA" makes reference to the use and procurement of parts and pieces sourced both domestically and globally and assembled in the United States of America. All final assembly, testing, service, warranty, repair are performed at our facility here in the United States. Claims made regarding ISO Certifications are evaluated by 3rd party compliance auditing bodies as is the same form any claims made for CE certification. The term UI pertains to underwritten and insured which the manufacturer maintains at all times product liability insurance which is underwritten and insures the manufacturers products and protects both the manufacturer and purchaser of the equipment. Shockwave PRO USA LLC, Pulse Wave, or Asclepius Medical Holdings LLC hold a vendor partnership with NCMIC, NCMIC is a copyright and trademark owned by NCMIC. Claims made regarding CE Credit may not be applicable for all US States. Please check with the support team to ensure our CE credits are allowable in your state. The Pulse Wave device is classified as a low-intensity extracorporeal shockwave therapy. This value is within the range of low-intensity extracorporeal shock wave therapy (ESWT), which is generally defined as having an energy flux density below 0.1 mJ/mm². Any use of provided information, schematics, technical specifications, manuals, educational materials by outside parties is strictly prohibited and will be prosecuted to the full extent of the law. Some measurements and technical specifications are extrapolated from preexisting comparative and established values when direct numerical values are not directly available. The phrase or terminology "no consumables" makes reference to the technology not needing to be constantly replaced or maintenance, and in fact the applicator itself which contains our parabolic reflector technology has no determinant life span, meaning we do not know if or when it will cease to function and testing has revealed most applicators are capable of 2 to 4 million impulses at current. In fact if going by the current accepted definition of the a medical consumable: "A medical consumable is any medical supply or item that is intended for one-time use or is used up during a medical procedure or over a short period of time. These items are not reusable and need to be replenished regularly." Then in fact this unit does not use consumables.

8.CGI Disclaimer

Some images in part or whole have been generated utilizing Computer Graphic Imagery to display either detail or 3D structure. Some internal components may be enlarged to show detail. All images contained in this website are protected under copyright and trademark law and should not be used or duplicated in anyway by any outside party. The images shown on this website or in marketing material due to CGI alteration may not look exactly like the machine, unit, or components themselves. Proportions, ratios, and color may be altered to show 3D animation, detail, and altered to fit certain aspect and photo requires.