APPLICATION PACKET. Professional Use Waiver

Transcription

1 Professional Use Waiver InnoPen InnoPen (Microneedle Therapy System ) is a skin treatment device designed and manufactured by - Clinical Resolution Laboratory, Inc. (a California corporation). All InnoPen models; InnoPen MD and InnoPen PRO are currently available in the U.S. market and are FDA registered as a Type I supplementary medical instruments. All components are produced in a high-tech ISO9001 quality-controlled manufacturing facilities. InnoPen is made in the U.S.A. General Description and Specification InnoPen is a medical precision instrument, an automated microneedling device with a unique, dual spring-loaded disposable needle cartridge called InnoTip that uses an automated, vibrating stamp-like motion to create micro channels in the skin. InnoPen Function Input Power Dimensions Weight Microneedling Device 5V = 1A H: 5.4in 93g or 97g with InnoTip attached InnoTip Function Microneedling Cartridge (Disposable) Dimensions H: 1.7in * D: 1 in Weight 4.12g Needle Depth 0 to 2.0mm InnoPen - Adaptor Rating Input AC V Frequency 50/60 Hz Output DC 5-6V GUARANTEE: InnoPen comes with a lifetime warranty on manufacturer and/or mechanical defects. Clinical Resolution Lab, Inc. does not cover device malfunction due to user errors and/or damage caused by accidental or natural catastrophes. InnoTips, patented disposable needle cartridges, are sterilized with gamma radiation and sealed in a hermetic pouch and are guaranteed to be 100% contaminant-free upon delivery. Storage and Use InnoPen should be turned off and the A/C power unit unplugged during non-use. Never leave the InnoPen unattended while it is turned on. InnoPen should be stored in a cool, well ventilated and dry area. Please keep out of reach of children. InnoPen should be used only on the skin and should not be used for any other purposes than indicated. User misuse is not covered under warranty. Care of InnoPen InnoPen device should be disinfected before and after each use with an antiseptic wipe made safe for electronic devices. InnoPen should be handled with care. Never pull on the A/C power cord; a damaged cord can cause power shortening of the device. InnoPen should not be dropped, immersed in water or placed in or nearby heat

2 Professional Use Waiver MTS Roller MTS Roller (Microneedle Therapy System) is a skin treatment device designed and manufactured by Clinical Resolution Lab, Inc. (a California corporation). All MTS Roller models are currently available in the U.S. market (see below) and are FDA registered as a Type I supplementary medical instruments. All components are produced in a high-tech ISO9001 qualitycontrolled manufacturing facilities. MTS Rollers are made in the U.S.A. and patented. General Description MTS Roller is a durable and high-quality precision tool. The barrel and handle are made from medical grade Lexan polycarbonate resin. The axle is a polished stainless steel axle. The 200 bristles (needles) are made from surgical stainless steel. A patented manufacturing process holds the needles permanently in place to within 0.02mm of the specified length from the roller base. All rollers have unique qualitycontrol serial numbers. GUARANTEE: 100% Contaminant-Free MTS Rollers are sterilized with gamma radiation and sealed in a hermetic pouch and are guaranteed to be 100% contaminant-free upon delivery. Storage and Use Polycarbonate resin does not degrade from prolonged use or storage. Roller models (CR2/MR2, CR3/MR3) should be replaced after ~6 months of regular use (2 to 3 times per week). A clinical roller (CR5/MR5) can be used up to ~10 treatments. Medical Roller (CR10/MR10, CR15/MR15, CR20/MR20) is only for one time use. Rollers that have been dropped or bumped should be replaced immediately. MTS Rollers should not be transferred between patients. Keep rollers in the protective case when not in use. For more information, consult CRL protocol guides. Care of MTS Rollers Current MTS Roller models can withstand repeated immersion in cold sterilization agents such as germicides (Phenol, Ethyl Alcohol) and Cidex (Glutaraldehyde). Rollers should be completely dry before soaking to prevent dilution of the sterilization agent. The soak time depends upon the manufacturer's specifications. Rinse rollers thoroughly before using and return to its protective case after drying.

3 Waiver of Liability Buyer (named signor on the Certificate of Professional Clinical Status and also signing below) assumes sole responsibility for the use of InnoPen and/or MTS Roller. Buyer also assumes complete and full responsibility without exception for any liability (material, financial, medical, and/or psychological) that may arise from the use of InnoPen, MTS Roller, and/or solutions. InnoTip, disposable needle cartridge is a single use apparatus and should never be reused. Buyer completely indemnifies and holds harmless Clinical Resolution Lab, Inc., its officers, representatives, and/or agents from any judgment, any arbitration, and/or any other settlement brought with or without cause. Clinical Resolution Lab, Inc. will repair and/or replace a defective InnoPen and/or MTS Roller that fails during normal usage. Buyer also acknowledges that until further notice, Clinical Resolution advises that MTS Rollers CR2/MR2, CR3/MR3, CR5/MR5 should be sterilized by cold sterilization processes between usages. Buyer also acknowledges that Clinical Resolution advises that InnoPen and/or MTS Roller should not be autoclaved. Autoclaving the InnoPen and/or MTS Roller will void the warranty. MTS Rollers CR10/MR10, CR15/MR15 and CR20/MR20 are sold as single-patient use, supplemental surgical tools for use in the clinical environment only under supervision of a physician. MTS Rollers CR2/MR2 and CR3/MR3 are sold as single-patient use take-home tools to be used under the guidance of a physician. InnoPen MD is a medical instrument for use in a clinical environment only under supervision of a physician. InnoPen PRO is an aesthetic professional instrument for use in skin care clinics or day spas by the licensed aestheticians/cosmetologists. Other terms and conditions apply per CRL, Inc. invoicing and payment policies. I agree to the terms and conditions of the above Waiver of Liability. (Sign and date) Company: Name (print): Signature: Date:

4 APPLICATION FORM Thank you for choosing MTS (Microneedle Therapy System) by Clinical Resolution Laboratory, Inc. CRL Complete the application form to set up a professional account and to qualify for the dealer/wholesale pricing on all products offered by CRL. Please fax back the completed application form along with a copy of your PROFESSIONAL LICENSE for verification to our corporate office, or a PDF/Scanned version of the completed document to info@clinicalresolution.com. For any questions please call 877-KNOW-MTS ( ). Certification of Professional Clinical Status Practitioner s Name (Buyer): Phone: Business Name (dba): Website: Mailing/Billing Address (stamp or label): License Type: License/Certification Number: Shipping Address (if different than mailing/billing): Are you currently in practice? YES or NO Years in Practice: Your Clinic Specialty(ies): Reseller Permit # (if in California for sales tax exemption) Authorized personnel to place order(s) on behalf of said business: List by name and title. I am the Practitioner named above. All of the information I have provided is accurate to the best of my ability. (Sign & Date)

5 APPLICATION FORM Credit Card Information Credit Card: Visa Master AmEx Discover (check one) Credit Card No.: Expiration Date: / (MM/YY) CVV Code: Card Holder's Name: Billing Address: Signature: Date: Clinical Resolution Laborato y, Inc. (CRL) requires that you certify your application by submitting an electronic signature to certify that all the information provided is accurate and true.