Instruction for Use: MirrorMe3D Splint LT Kit for Patients

--> If you are experiencing any discomfort or reaction to the splint, immediately discontinue the use of the splint, and Splint LT Kit, and contact your doctor.

IMPORTANT USE INFORMATION

The MirrorMe3D Splint LT™ Kit is a set of external nasal splints individually designed based on a surgeon’s treatment plan to facilitate healing, promote the control of edema and to protect the nasal tip shape during postoperative recovery.

Patients should follow their surgeon’s instructions regarding the application and use of the MirrorMe3D LT™ Kit or its component splints.

Rx Only
Federal Law (USA) restricts these devices to sale by or on the order of a physician.

Contraindications, Warnings and Precautions

Contraindications

The MirrorMe3D Splint LT™ Kit, nor any of its parts, should not be used if any of the following occur:

Warnings

Precaution

If you experience any discomfort or sign of infection, stop use immediately and contact your surgeon.

INDICATIONS FOR USE

MirrorMe3D Splint LT™ Kits, and their component parts, are patient specific devices prescribed by a surgeon for patient use following rhinoplasty procedures. Proper postoperative care can facilitate healing, promote the control of edema and help to protect the nasal tip shape and position during the healing process.

Indications for Use:

The MirrorMe3D Splint LT™ Kits are intended to be used for rhinoplasty postoperative care to optimize the healing process. The set of progressive, patient specific 3D printed nasal splints are applied under the direction of the surgeon. The standard timeframe for maximizing effectiveness is for use during the first three (3) months post operation.

Specific Indications for Use:

Postoperative rhinoplasty care to promote healing by applying compression to the nose to control edema.

Because the tip of the nose is cartilaginous and susceptible to movement, if a postoperative result needs additional intervention to achieve the desired outcome, the splint can be used to support the surgeon's goals to create the best possible end result

Splint Kits:

The MirrorMe3D Splint LT™ Kit uses a patient's 3D imagery to create a set of 3 graduated splints - the first splint is designed to be applied 5-7 days postoperatively, and the remaining splints are to be applied over the course of 4-6 weeks, based on your surgeon’s instructions. Each subsequent splint gradually becomes smaller to accommodate the expected changes in edema during the recovery process.

Instructions for Use:

Follow these steps for application and removal of the splints unless your surgeon has given you customized instructions.

In most cases, for 5-7 days post surgery, patients will wear the taping and/or splint applied by the surgeon. After cleaning and drying the skin, the MirrorMe3D splint is to be applied as directed by your surgeon using tape and/or a liquid adhesive. Place the splint on your nose, starting from the tip, applying it gently until reaching the radix. When your surgeon has instructed you to remove or replace the splint, start from the radix and gently pull the splint toward the tip of the nose.

Cleaning

MirrorMe3D splints are made of a biocompatible plastic. They are shipped in a non-sterilized state. To avoid the possibility of infection, clean the splints using a topical antibacterial soap before use.


TERMS AND CONDITIONS

INDEMNIFICATION. To the extent permitted by applicable law, I hereby agree to indemnify and hold harmless MirrorMe3D (herein “MM3D”), its officers, directors, employees, successors and assigns, from and against any and all liabilities, demands, claims, actions or causes of action, judgments, proceedings or investigations, losses, fines, penalties, damages, costs and expenses, including, without limitation, reasonable attorneys’ fees (collectively, “Damages”), that may be sustained, suffered or incurred by any of them arising from, out of, in connection with, or by reason of (a) the death or injury of any person, or loss or damage to property, resulting from the Products used in connection with the Case if such Products were (i) fabricated in accordance with the patient data for the Case, including but not limited to any 3D or other images (the “Patient Data”) that were supplied to MM3D by me or my employees, agents or designees, or (ii) used by me or my employees, agents or designees in a manner not intended or sanctioned by MM3D, or (iii) altered, added to, or enhanced by me or my employees, agents or designees, (b) the negligence or willful misconduct of me or of my employees, agents or designees in the use of the Products, or (c) the design, plan and/or application or implementation of the Services.

LIMITED WARRANTY OF PRODUCTS. MM3D hereby warrants that upon delivery of the Products, such Products will (i) be new and free from defects in material and workmanship, and (ii) conform to the Patient Data supplied to MM3D and the Plan. Notwithstanding the foregoing, the warranties given by MM3D for the Products are hereby limited as follows, and no warranty is given by MM3D with respect to any Products if any alterations, additions, or enhancements are made to the Products after delivery: (a) MM3D is not responsible for the accuracy of the Patient Data. Any damages caused by the Products, or your inability to use the Products, resulting from inaccurate, incomplete or poor-quality Patient Data shall be your sole responsibility. (b) Because of biological differences in individual patients, the Products cannot be, and are not, guaranteed to be 100% effective under all circumstances. In addition, because MM3D has no control of the condition under which the Products are used, nor any involvement in the diagnosis of the patient, the method of use or administration, or handling of the Products after delivery, MM3D cannot and does not warrant either a good result or against an ill effect to the patient following use or application of the Products. Final determination of the suitability of the Products for the use contemplated by you or your employees, agents and designees is your sole responsibility, and MM3D shall in no way be responsible for the suitability of the Products for any particular use or with any particular patient. (c) The Products, once delivered to you, are not in MM3D’s control and will be put to uses under circumstances wholly unknown to MM3D. Any losses, injuries or Damages to persons or property caused by the alteration of, addition to, or enhancement to the Products after delivery are not the responsibility of MM3D. This warranty is the exclusive warranty applicable to the Products. MM3D SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Some states do not allow disclaimers of implied warranties. In those states, the implied warranties expressed above shall be specifically limited in duration to ten (10) business days. Some states do not allow limitations on how long an implied warranty lasts. Where such limitations on the duration of implied warranties exist, the limitations on the duration stated in this section will not apply. In no event shall MM3D be liable to you for any special, consequential, incidental or indirect Damages, however caused, on any theory of liability. In addition, in no event shall MM3D’s maximum liability to you exceed the amounts actually paid by you to MM3D for the Products and Services provided pursuant to the Surgeon Agreement to which these Terms and Conditions are attached.

NO WARRANTY FOR SERVICES. To the extent permitted by applicable law, I acknowledge and understand that MM3D does not warrant and is not responsible for the outcome of any surgery as a result of the provision of the Services provided to me or my employees, agents or designees in connection with the Case.

RELEASE. To the extent permitted by applicable law and except as otherwise provided herein, I hereby waive and release MM3D from all Damages related to the Products and Services provided to me or my employees, agents or designees in connection with the Case.

WARNING If the Products are modified in any by the patient, the warranty is void and MirrorMe3D shall have no liability or indemnity obligations.

Contact Us:

MirrorMe3D, LLC

222 W 37th St., Ste 1506, New York, NY 10018
www.mirrorme3d.com

hello@mirrorme3d.com