Appliance Wire Disengagement Hand Instrument Instructions

AENGLISH Product Name 3M™ SmartClip™ Appliance Wire Disengagement Hand Instrument, 804-160, 1/Ea Product Description The SmartClip Appliance Wire Disengagement Hand Instrument is a specially modified stainless-steel plier used to remove archwires from SmartClip™ Brackets. Intended Use This product is intended for use in orthodontic treatment.

Disengagement 1. Approach archwire with disengagement instrument from occlusal or gingival side. (Figure 1) 2. Place instrument hooks under archwire keeping the bracket between the instrument hooks. (Figure 2) Make sure the instrument hooks are not under the bracket extensions holding the clips to avoid debonding or breakage. The instrument hooks are to be mesial and distal of the bracket only. 3. Squeeze handles. (Figure 3) Note: Repeat procedure for each bracket.

Indications for Use The SmartClip Appliance Wire Disengagement Hand Instrument removes archwires from SmartClip Brackets by sliding the instrument hooks beneath the archwire and lifting from the archwire slot and the bracket ligating mechanism by squeezing the handles. Contraindications None

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Intended Users Educated orthodontic professionals, i.e. orthodontist, orthodontic assistants/hygienists, who have theoretical and practical knowledge on usage of orthodontic products. Intended Patient Population includes children, teens and adults as recommended by an Orthodontist. An Orthodontist is a dental specialist who is concerned with the study and treatment of malocclusions (imperfect positioning of the teeth when the jaws are closed), which may be a result of tooth irregularity, disproportionate jaw relationships or both.

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Clinical Benefit The SmartClip Appliance Wire Disengagement Hand Instrument is confirmed to be safe and perform as intended. The clinical benefits include those of specifically designed orthodontic hand-held devices intended to perform various tasks during orthodontic treatment. These tasks include disengaging archwires. Precautions For Patients Safety glasses recommended for patient when using these instruments. For Dental Personnel Use instruments for indicated use only. Failure to do so may result in breakage of the instrument and injury to patient or orthodontic professional. Safety glasses recommended for orthodontic staff when using these instruments. Stainless steel contains nickel and/or chromium. A small percentage of the population is known to be allergic to these metals. If an allergic reaction occurs, direct patient to consult a physician. Instructions for Use

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Slide Replacement 1. Using a pointed object, approach tab. 2. Push tab. (Figure 5) 3. Remove slide. (Figure 6) 4. Obtain new slide. Note: Ensure proper orientation of slide. (Figure 7) 5. Push slide while holding handles in closed position. (Figure 8)

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3M Unitek – Authorized Service Center Precision Plier Service 14175 Telephone Avenue, Suite D Chino, CA 91710-5762

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Hook Replacement 1. Insert Allen wrench* on first setscrew (Figure 9) and rotate counterclockwise until handles open easily. (Figures 9 & 10) 2. Insert Allen wrench on top setscrew and rotate counter-clockwise until hooks are free. (Figures 11 & 12) 3. Obtain new hooks. Note: Ensure proper orientation of hooks. (Figure 12) 4. Tighten top setscrew until first resistance is felt. (Figure 13) 5. Close plier handles. Insert Allen wrench and tighten first setscrew clockwise until first resistance is felt and then rotate counter-clockwise 1⁄4 turn. (Figure 14) 6. Obtain new slide. Note: Ensure proper orientation of slide. (Figure 15) 7. Push slide while holding handles in closed position. (Figure 16) *Included with Hook Insert Replacement Kit (P/N 804-162) Storage Conditions Not applicable Cleaning and Disinfection Refer to Reprocessing Instructions for Reusable Non-Sterile Devices, REF 011-650. SDS and Disposal Safety Data Sheets are not applicable to instruments. To be disposed in accordance with the local or regional regulations. Please pay special attention to the disposal of contaminated waste to avoid health risks because of improper handling. Customer Information Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority. No person is authorized to provide any information which deviates from the information provided in this instruction sheet. Warranty 3M Unitek warrants that this instrument will be free from defects in materials and manufacture for a period of 1 year from the date of purchase. Failure to follow recommended use, maintenance and sterilization procedures will void all warranty claims. Recommended maintenance includes cutter tip/blade re-sharpening and reconditioning (cleaning, polishing, adjusting screw as necessary) every six months. 3M Unitek’s sole obligation and customer’s sole remedy in the event of a claimed defect shall be limited to, at 3M Unitek’s option, repair, replacement of the product, or refund of the purchase price. All instruments should be sent to the 3M Unitek Authorized Service Center at the address below for evaluation to determine credit, replacement, or repair. The Authorized Service Center will determine, upon receipt of instrument, if the instrument is to be covered by warranty. Materials and manufacturing are the only items covered by this warranty. Misuse or abuse will void warranty. Buyer will be contacted regarding repair charges for out of warranty instruments.

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Phone: 1-800-229-9060 USA, Canada Worldwide: Phone: 909-590-2085 Fax: 909-590-8604. Waiver of Implied Warranties ALL IMPLIED WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR USE ARE DISCLAIMED. Limitation of Liability Except where prohibited by law, 3M Unitek will not be liable for any loss or damages arising from any product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence or strict liability. Symbol Title

Symbol

Description and Reference

Manufacturer

Indicates the medical device manufacturer as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. Source: ISO 15223, 5.1.1

Authorized Representative in European Community

Indicates the authorized representative in the European Community. ISO 15223, 5.1.2

Date of Manufacture

Indicates the date when the medical device was manufactured. Source: ISO 15223, 5.1.3

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified. ISO 15223, 5.1.5

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified. ISO 15223, 5.1.6

Consult instructions for use or consult electronic instructions for use

Indicates the need for the user to consult the instructions for use. Source: ISO 15223, 5.4.3

Medical Device

Indicates the item is a medical device.

Unique device identifier

Indicates bar code to scan product information into patient electronic health record.

Importer

Indicates the entity importing the medical device into the EU.

UKCA Mark

Indicates conformity to all applicable regulations and/or directives in the United Kingdom (UK), for products placed on the market in Great Britain (GB).

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