3M Reprocessing Instructions for Reusable Non-Sterile Devices

AENGLISH Product Name Reprocessing Instructions for Reusable Non-Sterile Devices Product Description Instructions for sterilizing reusable non-sterile devices. This IFU applies to the following listed part numbers. REF 704-356, 3M™ Ortholux™ LED Light Guide REF 704-456, 3M™ Ortholux™ Luminous Curing Light Light Guide REF 709-036, 3M™ Lip Expanders REF 712-032, 3M™ Adhesive Dispensing Gun REF 800-705, 3M™ Unitek™ Plier/Cutter Combo REF 800-734, 3M™ Unitek™ Universal Separating Pliers REF 803-003, 3M™ Unitek™ Single-Ended Ligature Director REF 803-007, 3M™ Unitek™ Double-Ended Ligature Director REF 803-530, 3M™ Unitek™ Lingual Weingart Utility Pliers with 60° Bend REF 803-531, 3M™ Unitek™ Lingual Cinch Back Pliers REF 803-532, 3M™ Unitek™ Lingual Anterior Debonding Pliers REF 803-535, 3M™ Unitek™ Lingual Detailing Pliers REF 803-550, 3M™ Unitek™ Lingual Light Wire Flush Cut Distal End Cutter REF 803-551, 3M™ Unitek™ Lingual Heavy Wire Flush Cut Distal End Cutter REF 803-552, 3M™ Unitek™ Lingual Distal End Cutter REF 803-553, 3M™ Unitek™ Lingual Straight Ligature Cutter REF 803-570, 3M™ Unitek™ Lingual Straight Mathieu Pliers REF 803-571, 3M™ Unitek™ Lingual Curved Mathieu Pliers REF 803-572, 3M™ Unitek™ Lingual Bracket Placement Tweezer REF 803-573, 3M™ Unitek™ Lingual Straight Mosquito Forceps REF 803-580, 3M™ Unitek™ Lingual Director REF 803-581, 3M™ Unitek™ Lingual Short Probe REF 804-152, 3M™ SmartClip™ Appliance Wire Insertion Hand Instrument, .022 REF 804-153, 3M™ SmartClip™ Appliance Wire Insertion Hand Instrument, .018 REF 804-155, 3M™ Unitek™ Open - Close Instrument for the Ultra SL System REF 804-160, 3M™ SmartClip™ Appliance Wire Disengagement Hand Instrument REF 804-170, 3M™ Unitek™ Self-Ligating Bracket Debonding Instrument REF 804-171, 3M™ Unitek™ Bracket Placement Instrument REF 804-175, 3M™ Unitek™ Debonding Instrument for the Ultra SL System REF 805-035, 3M™ Unitek™ Convertible Cap Removing Pliers REF 810-001, 3M™ Unitek™ Gurin Wrench, Extra Small/Small REF 810-002, 3M™ Unitek™ Gurin Wrench, Medium and Large REF 811-001, 3M™ Molar Band Seater REF 900-700, 3M™ Unitek™ Prestige Weingart Utility Pliers REF 900-701, 3M™ Unitek™ Prestige How Utility Pliers, Offset REF 900-702, 3M™ Unitek™ Prestige How Utility Offset Plier REF 900-703, 3M™ Unitek™ Prestige Tweed Rectangular Arch-Forming Pliers REF 900-704, 3M™ Unitek™ Prestige Jaraback Pliers REF 900-705, 3M™ Unitek™ Prestige Three-Jaw Wire Bending Pliers REF 900-706, 3M™ Unitek™ Prestige Lingual Lock-Forming Plier REF 900-707, 3M™ Unitek™ Prestige Omega Loop Forming Pliers REF 900-709, 3M™ Unitek™ Prestige Bird Beak Plier REF 900-710, 3M™ Unitek™ Prestige Light Wire Bird Beak Pliers REF 900-711, 3M™ Unitek™ Prestige Band Seating Pliers REF 900-712, 3M™ Unitek™ Prestige Band Removing Pliers, Short Beak REF 900-713, 3M™ Unitek™ Prestige Posterior Band Removing Pliers REF 900-716, 3M™ Unitek™ Prestige Hollow Chop Pliers REF 900-717, 3M™ Unitek™ Prestige Bond Removing Plier REF 900-720, 3M™ Unitek™ Prestige Tweed Loop Forming Pliers REF 900-721, 3M™ Unitek™ Prestige Arch Bending Pliers REF 900-729, 3M™ Unitek™ Prestige Small 3-Jaw Wire Bending Pliers REF 900-735, 3M™ Unitek™ Prestige Slimnose Weingart Utility Plier 1

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REF 900-750, 3M™ Unitek™ Prestige End Cutter, Distal REF 900-751, 3M™ Unitek™ Prestige Hard Wire Cutter REF 900-752, 3M™ Unitek™ Prestige Wire Cutter REF 900-753, 3M™ Unitek™ Prestige Pin and Ligature Cutter REF 900-754, 3M™ Unitek™ Prestige Miniature Pin and Ligature Cutter REF 900-755, 3M™ Unitek™ Prestige Micro-Miniature Pin and Ligature Cutter REF 900-756, 3M™ Unitek™ Prestige Universal Cutter, Safety Hold REF 900-757, 3M™ Unitek™ Prestige Universal Cutter, Long Handle REF 900-815, 3M™ Unitek™ Prestige Double-Ended Dual Purpose Instrument REF 900-822, 3M™ Unitek™ Sickle-Style Cement Remover and Bracket Positioner REF 900-823, 3M™ No. 5 Front-Surface Mouth Mirror REF 900-832, 3M™ Lightweight Band Seater and Pusher REF 900-836, 3M™ Unitek™ Bracket Positioning Gauge One, 2.0-2.5 mm REF 900-837, 3M™ Unitek™ Bracket Positioning Gauge Two, 3.0-3.5 mm REF 900-838, 3M™ Unitek™ Bracket Positioning Gauge Three, 4.0-4.5 mm REF 900-839, 3M™ Unitek™ Bracket Positioning Gauge Four, 5.0-5.5 mm REF 900-840, 3M™ Unitek™ Bracket Positioning Gauge Five, 6.0-6.5 mm REF 900-841, 3M™ Unitek™ Bracket Positioning Gauge Set, Gauges One to Four, 1 Kit REF 900-850, 3M™ Unitek™ Debonding Instrument Intended Use This product is intended for use in orthodontic treatment. Indications for Use This document refers only to the cleaning, disinfection and sterilization of the above listed instruments. Where applicable refer to the specific instrument Instructions for Use to determine Indications for Use. The user is responsible for inspecting instruments prior to each use. Contraindications None Intended Users Educated orthodontic professionals, i.e. orthodontist, orthodontic assistants/hygienists, who have theoretical and practical knowledge on usage of orthodontic products. Clinical benefit Cleaning, disinfection and sterilization are required for the instrument’s first use after removal of the protective packaging and prior to each use. Effective cleaning and disinfection is an indispensable requirement for proper instrument sterilization. Three cleaning and disinfection procedures are provided: an automatic procedure using a thermal disinfector unit (washer-disinfector) and two manual procedures (ultrasonic cleaning/disinfection and manual cleaning/disinfection). The user is responsible for the sterility of the instruments. Ensure that only validated procedures are used for cleaning, disinfection and sterilization. Sterilization equipment must also be maintained and checked regularly, as well as the validated parameters for the cleaning, disinfection and sterilization cycles. Precautions 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 patient and orthodontic staff when using these instruments. Stainless steel contains nickel and 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. Before cutting wire in the mouth with any non-safety hold cutter, place a gauze pad or cotton roll next to the wire end to catch wire fragments and to prevent injury to patient. REF 800-705 Unitek Pliers/Cutter Combo This instrument is designed for use only outside the oral cavity. Appropriate eye protection (Safety glasses) are recommended when cutting wire to avoid eye injury from wire ends that may be ejected from cutting blades. This instrument is designed to cut only 0.016 x 0.022 Nitinol. This instrument is specially designed to meet the bending specifications of Dr. Kim’s MEAW and combination loops. See Special Instructions under Cleaning and Disinfection, subsection 11, for the following instruments: Hinged Instruments REF 704-456, Ortholux Luminous Light Guide REF 712-032, Adhesive Dispensing Gun English

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REF 804-160, SmartClip Appliance Wire Disengagement Hand Instrument REF 804-171, Unitek Bracket Placement Instrument REF 811-001, Molar Band Seater • Do not use a metal brush or steel wool to clean instruments, as this will damage the finish of the instrument. • Do not apply mineral oil or silicone lubricants to instrument hinges because they introduce microorganisms, prevent penetration of the steam to the instrument’s surface, and are difficult to remove. • Do not expose instruments, cassettes, trays or sterilization containers to temperatures higher than 141°C / 284°F. Exposure to higher temperatures is the responsibility of the user. • Do not use detergents or disinfectants containing the following substances: (a) Strong alkalines (>pH 9) (b) Strong acids (<pH4) (c) Phenols or iodophors (d) Hydrogen peroxide (H2O2) (e) Interhalogenic agents / halogenic hydrocarbons / iodophors (f) Strong oxidizing agents / peroxides (g) Organic solvents • Water quality may influence the result of the cleaning and disinfection of the instruments. Therefore, use only sterile or purified water, such as purified water/ highly-purified water (PW/HPW according to the pharmacopoeias) for cleaning and disinfection processing steps that require water. Corrosion of instruments may be caused by high contents of chloride or other minerals in tap water. If stains and corrosion occur, and other reasons can be excluded, it may be necessary to test the quality of the tap water in your area. Most water quality problems can be avoided with the use of deionized or distilled water. • Sterilization is required for all instruments. • Please refer to subsection 8 for additional instructions for specific instruments. Instructions for Use Where applicable refer to the specific instrument Instructions for Use. Storage Conditions Store instruments after sterilization in a dry and dust-free place. Sterilization can only be maintained if the instruments remain packaged or wrapped, impermeable to microorganisms, following a validated sterilization. The status of the sterilization must be clearly indicated on the wrapped packages or the containers. For safety reasons, keep sterile and non-sterile instruments separated. Cleaning and Disinfection 1. Preparation at Point of Use • Handle used and contaminated instruments with protective gloves that fulfill the requirements of Directive 89/686/EEC. • Remove excess soil with disposable cloth/paper wipes. • Avoid drying and fixation of tissue debris onto the surface of instruments. 2. Containment & Transportation • Contain contaminated instruments in an approved sealed container during transport from the point of use to the decontamination area. • Reprocess instruments as soon as is reasonably practical following use. 3. Preparation Selection of enzymatic cleaning detergents – Consider the following in the selection of detergents • Suitability of the detergent for cleaning instruments. • Compatibility of the detergent with instruments (see Precautions). • Compatibility of the detergent with the thermal disinfector unit (washerdisinfector) or with ultrasonic treatment. • Instructions of the detergent manufacturer regarding concentration and soaking time. Selection of disinfectant – Consider the following in the selection of disinfectants: • Compatibility of the disinfectant with the enzymatic detergent and instruments (see Precautions). • Approved efficiency of disinfectant, i.e., DGHM/VAH, RKI approval or CE marking. • Instructions of the disinfectant manufacturer regarding concentration and soaking time. 3

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Pre-treatment (required for all three cleaning and disinfection procedures listed in section 6) • Remove coarse impurities on the instruments immediately after application (within a maximum of 2 hours). • Immerse the instruments in enzymatic detergent and remove debris with a soft brush–do not use metal brushes or steel wool. • For hinged instruments, open and close the hinge at least 5 times with the instrument submerged in an enzymatic detergent. • For instruments with blind holes (i.e., a hole that does not go through the material), rinse the blind hole intensively with a syringe (use a syringe with a needle if the size of the hole is too small to adequately rinse with just the syringe). • Follow the concentration, time and temperature instructions of the manufacturer(s) for the detergents and disinfectants. 4. Cleaning and Disinfection If possible, an automatic procedure in a Washer / Disinfector unit should be used for cleaning and disinfection of the instruments. A manual procedure should only be used if an automatic procedure is not available or if such a method is not compatible with specific materials; in this case, the significantly lower efficiency of a manual procedure must be considered. Method 1 – Automated Cleaning & Disinfection Equipment: Thermal Disinfector Unit (Washer-Disinfector) that meets ISO 15883 requirements. • Use high quality water, e.g., PW/HPW (see Precautions). Washer-Disinfector Procedure 1. If applicable, disassemble instruments and/or open hinged instruments completely. 2. Place the instruments in the thermal disinfector unit (washer-disinfector), assuring no contact between the instruments. 3. Initiate the cycle. 4. Remove the instruments from the thermal disinfector unit (washer-disinfector) after the end of cycle. 5. Carefully inspect the instrument to ensure no visible soil remains. Repeat the cleaning procedure if any soil remains. 6. If a dry cycle was not used, dry the instrument with a clean, soft, lint free cloth. Validation of automated cleaning and thermal disinfection was conducted by an independent accredited test laboratory using a Miele thermal disinfector unit and the enzymatic detergent Neodisher medizym. Method 2 – Ultrasonic Cleaning & Disinfection Equipment: Ultrasonic Cleaning Unit. Cleaning Procedure: 1. If applicable, disassemble instruments and/or open hinged instruments completely. 2. Completely submerge instruments in the enzymatic detergent for the time recommended by the detergent manufacturer, or for a minimum of 5 minutes. Note: There should be no contact between the instruments; do not overload the ultrasonic cleaning unit. 3. Use the processing time recommended by the manufacturer of the ultrasonic unit. If using a cassette, use the time recommended by the cassette instructions. 4. Remove instruments from the enzymatic detergent. Rinse thoroughly according to the detergent manufacturer instructions, or at least three times for thirty seconds each time with high quality water (see Precautions). 5. Inspect instruments for visible soil and repeat procedure if any soil remains. Chemical Disinfection Procedure: 1. Completely submerge instruments in the disinfectant solution for the recommended soaking time of the disinfectant manufacturer. There should be no contact between the instruments. 2. Remove instruments from the enzymatic detergent. Rinse thoroughly according to the detergent manufacturer instructions, or at least three times for thirty seconds each time with high quality water (see Precautions). Validation of cleaning and disinfection was completed by an independent accredited test laboratory using ultrasonic SONOREX SUPER RK 514 H, the enzymatic detergent Cidezyme/Enzol and the disinfectant Cidex OPA following the label instructions.

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Method 3 – Manual Cleaning and Disinfection Equipment: Not applicable. Cleaning procedure: 1. If applicable, disassemble instruments and/or open hinged instruments completely. 2. Completely submerge instruments in the enzymatic solution and soak for the recommended soaking time of the detergent manufacturer. If necessary, use a soft brush to carefully brush instrument. 3. Remove instruments from the enzymatic detergent. Rinse thoroughly according to the detergent manufacturer instructions, or at least three times for thirty seconds each time with high quality water (see Precautions). 4. Inspect instruments for visible soil and repeat procedure if any soil remains. Chemical Disinfection procedure: 1. Completely submerge the instruments in the disinfectant solution and soak for the recommended soaking time of the disinfectant manufacturer. There should be no contact between the instruments. 2. Remove instruments from the disinfectant solution and rinse them thoroughly according to the disinfectant instructions, or at least 3 times for one minute each time with high quality water, e.g., PW/HPW (see Precautions). Validation of cleaning and disinfection was demonstrated by an independent accredit test laboratory using the enzymatic detergent Cidezyme/Enzol and the disinfectant Cidex OPA following the label instructions. 5. Drying • Dry with a clean, soft, lint-free cloth in a clean place, or use filtered air for drying to prevent recontamination. • If drying is achieved as part of a washer-disinfector cycle, do not exceed 120°C / 248°F. • Completely dry instruments before packaging. 6. Inspection, Maintenance, Testing • Inspect instruments for impurities, damage and wear. Instrument cutting edges should be free of nicks. If instruments are still dirty, repeat cleaning and disinfection procedures. • Reassemble disassembled instruments. Check for smooth movement of hinge without excessive “play”. Locking (ratchet) mechanisms should be checked for action. • Lubricate hinges with a vapor-permeable lubricant (e.g., a paraffinic white oil) suitable for steam sterilization. Ensure the lubricant manufacturer certifies that the lubricant will not affect the sterilization efficiency of the oiled instruments, and that the biocompatibility of the lubricant will be maintained during the sterilization cycle. Packaging Consider the following in the selection of suitable sterilization containers: • Conformity with ANSI AAMI (EN) ISO 11607 (EN 868-8) • Suitable for steam sterilization (temperature resistance up to 140°C (284°F) • Sufficient protection of the instruments and the sterilization packaging against mechanical damage • Sterilization container or cassette – conduct regular maintenance according to the manufacturer’s instructions Alternatively, standard sterilization packaging (e.g., paper/foil, single or double packaging) can be used. Consider the following during the selection of suitable sterilization packaging: • Conformity with ANSI AAMI (EN) ISO 11607 (EN 868-2) • Suitable for steam sterilization (temperature resistance up to 141°C (286°F) • Sufficient protection of the instruments and the sterilization packaging against mechanical damage 7. Sterilization Use only the procedure recommended below. Other sterilization procedures are the responsibility of the user. • Use a dynamic air-removal/fractionated vacuum autoclave or a gravity displacement autoclave. If possible, a fractionated vacuum procedure should be used for sterilization. • The sterilizer should be validated according to ANSI AAMI (EN) ISO 17665 (and HTM 2010 if required by local regulations and guidelines). • Do not use the flash sterilization procedure. • Do not exceed a sterilization temperature of 138°C / 280°F. 5

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• Do not exceed sterilizer’s maximum load when sterilizing multiple instruments in one autoclave cycle • Hinged instruments should be sterilized with the hinge open • Use one of the following sterilization exposure times at the sterilization temperature: See section 8, Special Procedures, for additional sterilization exposure time and temperature for selected instruments. Autoclave

Gravity

Dynamic air-removal

Exposure time at 132°C

15 minutes

4 minutes

Exposure time at 134°C

15 minutes

3 minutes

Dry Time

30 minutes

30 minutes

Validation of steam sterilization was demonstrated by an independent accredited test laboratory using dynamic air-removal/fractionated vacuum and gravity autoclaves. 8. Special Procedures Hinged Instruments

Open and close instrument several times during cleaning process and disinfection processes. Lubricate hinge before sterilization and process in an open position during sterilization.

Hinged Instruments REF 704-456, Ortholux Luminous Light Guide REF 804-171, Unitek Bracket Placement Instrument

Use only the following to clean/disinfect these instruments. Method 1, Automated Cleaning & Disinfection, or Method 3, Manual Cleaning & Disinfection

REF 712-032, Adhesive Dispensing Gun

Use only Method 1, Automated Cleaning & Disinfection to clean/disinfect these instruments.

REF 804-160, SmartClip™ Appliance Wire Disengagement Instrument

Remove plastic slide and relax the lateral screw to enable full opening of the instrument prior to pretreatment, cleaning and disinfection (only packaging and sterilization in the mounted state). After sterilization, tighten the lateral screw with the Allen wrench that is supplied with the instrument. Plastic slide has been tested to withstand at least 20 reprocessing cycles. Replacement plastic slides are available (REF 804-161).

REF 811-001, Molar Band Seater

Clean metal tip with a brush.

SDS and Disposal Safety Data Sheets are not applicable to instruments. Refer to the manufacturer’s Safety Data Sheets of the specific materials used during reprocessing. 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 English

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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. Unitek™ Prestige Series Hand Instruments Special Warranty Information 3M Unitek warrants that this instrument will be free from defects in materials, manufacture or separation of brazed cutting edges for a period of 1 year from the date of purchase. 3M Unitek further warrants that this instrument will be resistant to corrosion for 5 years 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 buyer’s sole remedy in the event of a claimed defect shall be limited to, at 3M Unitek’s option, repair, replacement of merchandise, 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, manufacture, and corrosion resistance 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. 3M Unitek – Authorized Service Center Precision Plier Service 14175 Telephone Avenue, Suite D Chino, CA 91710-5762 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.

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.

CE Mark

Indicates conformity to European Union Medical Device Regulation or Directive.

Rx Only

Indicates that U.S. Federal Law restricts this device to sale by or on the order of a dental professional. 21 Code of Federal Regulations (CFR) sec. 801.109(b)(1).

Green Dot

Indicates a financial contribution to national packaging recovery company per European Directive No. 94/62 and corresponding national law. Packaging Recovery Organization Europe.

Package unit

Indicate the number of units in the package. Source: ISO 7000-2794

Refer to instruction manual/booklet

To signify that the instruction manual/ booklet must be read. ISO 7010-M002

For more information see, HCBGregulatory.3M.com

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 Glossary Symbol Title

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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

Medical Device

Indicates the item is a medical device.

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