3i Kits and Instruments Reprocessing Instructions for Use

Device

Intended Use a scalpel. It will typically be designed with a handle at the proximal end or for mounting into a dental drill, and have a cylindrical hollow tube-like head with a sharp cutting edge at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

GMDN*

Bone Profiler Kit Surgical Kit Drill Kit Ratchet Wrench Kit Torque Driver Kit Bone Tap Kit Screw Removal Kit

A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

44883

• •

Open End Wrench Ratchet Wrench

A hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

44901

• • • • • •

Cover Screw Inserter Driver Tip Abutment Driver Screw Removal Tool Ratchet Extension Ratchet Hex Driver with GemLock® Retention Coping Driver Hex Drivers Manual Hex Driver with GemLock® Retention Latch-Lock Hex Driver with GemLock® Retention Square Drivers Screw Driver Driver Tip Handle Certain® Placement Driver Tip with GemLock® Retention Torque Wrench Hex Driver with GemLock® Retention Locator Male Removal Tool Locator Tool/Driver

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

33968

A receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

13730

• • • • • • •

• • • • • • • • • • •

•

Kit / Box / Wash Tray

Page 2 of 10

• •

Device

Intended Use

GMDN*

Membrane Elevator Titanium Elevator

A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

38168

•

Osteotome

•

Copings**

•

Try-In Screw**

A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

44887

Dental copings are used to transfer the implant hex position or the abutment position to a laboratory model for use during the fabrication of the implant restoration. This is a single use device.

44880

A screw used to mechanically affix an abutment to the anchoring implant for initial fitting and adjustment. This is not an implantable device.

44880

* The Global Medical Device Nomenclature (GMDN) is a list of generic names used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. ** Single Patient Drills, Copings and Try-In Screw were included for completeness, cleaning and sterilization instructions do not apply.

Clinical Benefits: The clinical benefits of the instruments are primarily to facilitate appropriate alignment, sizing, positioning and explanation of the associated implants.

Target Patient Population: Any patient who has a “hopeless” tooth (or teeth) requiring extraction or has had a tooth extracted or “lost”, or has a congenitally missing tooth.

Intended User: The Dental Clinician, General Practitioner (DDS) dentist or specialist such as a Periodontist or Oral Surgeon, professional health care and laboratory personnel are the intended users.

Sterility: Page 3 of 10

Biomet 3i’s Kits and Instruments are sold sterile or non-sterile. Refer to the specific packaging for verification of sterility. Sterilize non-sterile product prior to use in patients. Some Biomet 3i products that are sold sterile are for single use only; refer to specific packaging for single use only designation.

Single Use: Do not reuse single use or single patient devices. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.

Warnings and Precautions: • • • •

• • • • • • • • • • • • • • • •

Universal Precautions should be observed by all clinic/hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers. Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of the instruments. Soft-bristled, nylon brushes and pipe cleaners should be used. Cleaning agents with low foaming surfactants should be used during manual cleaning procedures to ensure that instruments are visible in the cleaning solution. Manual scrubbing with brushes should always be performed with the instruments below the surface of the cleaning solution to prevent generation of aerosols and splashing which may spread contaminants. Cleaning agents must be completely rinsed from device surfaces to prevent accumulation of detergent residue. DO NOT stack instruments or place heavy instruments on top of delicate devices. Dry, soiled surgical instruments are more difficult to clean. DO NOT allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluids, bone and tissue debris, saline, or disinfectants to dry on used instruments. DO NOT place used instruments back into the tray prior to proper cleaning per the following cleaning procedure. Not following the cleaning procedure for used instruments carries the risk of cross contamination, infection and permanent nerve damage. Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringers Solution. The performance of a drill’s internal irrigation system may be adversely affected after passing multiple sterilization cycles. Only devices manufactured and/or distributed by Biomet 3i should be included in Biomet 3i instrument trays and cases. These validated reprocessing instructions are not applicable to Biomet 3i trays and cases that include devices that are not manufactured and/or distributed by Biomet 3i. Unless otherwise indicated, instruments and kits are NOT sterile and must be thoroughly cleaned and sterilized prior to use. Instruments should NOT be flash-autoclaved inside the instrument case or individually. Unwrapped instrument cases DO NOT maintain sterility. The procedures DO NOT apply to powered instrumentation. Instruments that are able to be disassembled should be disassembled prior to cleaning and sterilization. Care must be taken to avoid losing small parts. The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those detailed in these instructions l. User and processing personnel are directed to visually inspect the surgical instruments prior to use and before and after processing to ensure no visible damage, deterioration or excessive wear and to verify fitness for use. Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, including prolonged use, misuse, and rough or improper handling. Care must be taken to avoid compromising their performance. To maintain the quality of surgical instruments and trays, a standardized cleaning and sterilization protocol should be adopted. Twist Lock Impression Copings should not be used when an impression is made of multiple divergent implants. There is a risk of not being able to remove the impression tray from the copings once the impression material has set. One or more components of this devices contain the following substance defined as CMR 1B substances in a concentration above 0.1% weight by weight, when identified on the product label with the below symbol:

Cobalt; CAS No.:7440-48-4; EC No.:231-158-0 There are a few case studies in which patients were diagnosed with cancer while having a device manufactured from cobaltcontaining alloys in place that hypothesized at a casual nexus between the device and the diagnosis. However, current overwhelming peer-reviewed scientific evidence and a ZimVie risk assessment support that the incidence of developing cancer or suffering from adverse reproductive effects for patients with a device manufactured from cobalt-containing alloys or stainless steel alloys containing cobalt is negligible and comparable to the respective incidence for the general population.

Page 4 of 10

Recommended Procedures for Cleaning and Sterilization of Surgical Instruments and Kits

The recommended cleaning and sterilization procedures in this document apply to all Biomet 3i kits and the instruments listed above. Additionally, as indicated in Section G, Combination Cleaning and Disinfection Instructions for Instruments apply to Biomet 3i and Zimmer Dental instruments. To maintain the quality of Biomet 3i Instrumentation, the following procedures on the Biomet 3i validated process for cleaning and the validated sterilization cycles must be followed.

A. Materials Required for Procedures: Solutions • • • •

Neutral-pH detergent, or specialized cleaning solution Proteolytic enzyme detergent Tap water Purified water

Tools • • • • •

PPE: Personal Protective Equipment (gloves, goggles, apron, etc.) Glass beakers Soft bristled brushes of various sizes Thin nylon-wire brush (pipe cleaner brush) Autoclave-approved wraps or pouches

Equipment • • •

Ultrasonic cleaning unit Steam autoclave Automated Thermo-disinfector (for automated cleaning and disinfection)

B. Limitations and Restrictions: •

• •

• •

• •

Neutral pH, enzymatic, and alkaline (pH ≤ 12) cleaning agents are recommended and preferred for cleaning Biomet 3i reusable devices. Alkaline agents with pH ≤ 12 may be used to clean stainless steel and polymer instruments in countries where required by law or local ordinance; or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeldt-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents are thoroughly neutralized and completely rinsed from devices. NOTE: Cutting devices should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. NOTE: It is important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues. Some enzymatic solutions are specifically for breakdown of fecal matter or other organic contaminants and may not be suitable for use with Biomet 3i instruments. Where applicable, multi-component instruments should be disassembled for cleaning. Disassembly, where necessary, is generally self-evident. Care must be taken to avoid losing small parts. At point of use, soiled instruments must be removed from metal or polymer trays and moistened to prevent debris from drying before transportation to the reprocessing area for manual and/or automated cleaning procedures. Do not clean soiled instruments while in polymer or metal trays. NOTE: Any unused, single-use device that has been exposed to blood, bone, tissue, or body fluids must not be reprocessed and must be discarded. Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate mineral deposits on instruments (e.g. ultra-filter (UF), reverse-osmosis (RO), deionized (DI) distilled water (DW), or equivalent). Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning. Place used instruments in a container (e.g. glass beaker) filled with purified water if immediate cleaning is not possible. NOTE: Soaking in proteolytic enzyme solutions or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-to-reach areas (e.g. cannulated and tubular designs, etc.). These enzymatic solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein based materials from drying on instruments. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Prior to first use, the empty Dental Wash Tray (ZBDWT01) must be processed following the steps provided in section F or section G of this document. Reusable instruments may be cleaned and disinfected using an automated thermodisinfector when housed within Dental Wash Tray (ZBDWT01). An appropriate mesh basket can be used for the instruments that cannot be housed in Dental Wash Tray due to their size.

Page 5 of 10

• • •

Do not sterilize instruments in the Dental Wash Tray. Instruments should be wrapped individually or in a surgical tray as stated in section I or section J, respectively. Instruments must be sterilized following the parameters stated in section K of this document. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from solution to minimize the potential for drying prior to cleaning. Repeated processing, according to the instructions in this manual has minimal effect on the reusable instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended surgical use and not to reprocessing.

C. Preparation of Cleaning Agents: • • • • •

•

Neutral pH, enzymatic, and alkaline cleaning agents with low foaming surfactants are recommended. Alkaline agents with pH ≤ 12 may be used in countries where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and/or thorough rinsing. Only agents with proven efficacy (FDA approved, VAH listed, or CE mark) should be used. As a large variety of cleaning agents and disinfectants exists around the globe, Biomet 3i does not recommend any specific brand. All cleaning agents should be prepared at the use-dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. Dry powdered cleaning agents should be completely dissolved prior to use to avoid staining or corrosion of instruments and to ensure correct concentration. Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid).

D. Cleaning/Disinfection Options: Method

Rigorous Manual Cleaning Instructions for Instruments Rigorous Manual Cleaning Instructions for Trays Combination Cleaning and Disinfection Instructions for Instruments • •

Description

Enzymatic or alkaline soak and scrub followed by sonication.

Section E

Enzymatic or alkaline soak and scrub.

F

Enzymatic soak and scrub with sonication or alkaline soak with sonication followed by automated washer/disinfector cycle.

G

Biomet 3i recommends using Rigorous Manual Cleaning process for instruments (Section E) and trays (Section F). Instances where the local laws and ordinances require instruments to be disinfected prior to sterilization, Combination Cleaning and Disinfection method can be used. Combination Cleaning and Disinfection Instructions for Instruments are validated for Biomet 3i and Zimmer Dental instruments when used with Dental Wash Tray (ZBDWT01) for automated washer / disinfector cycle.

E. Rigorous Manual Cleaning Instructions for Instruments: 1.

Completely submerge instruments in an enzymatic or alkaline (pH ≤12) solution and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush).

2.

Remove the instruments from the enzymatic or alkaline solution and rinse in purified water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.

3.

Prepare a neutral-pH cleaning agent solution in a sonication unit. Completely submerge devices in cleaning solution and sonicate for 10 minutes at 40-50 kHz.

4.

Remove the instruments from the cleaning solution and rinse in purified water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.

5.

Repeat the sonication and rinse steps 3 and 4 above.

6.

Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe.

7.

Carefully inspect each device to ensure that all visible contamination has been removed. If contamination is noted repeat the cleaning process.

F. Rigorous Manual Cleaning Instructions for Trays: 1.

Completely submerge trays in an enzymatic or alkaline (pH ≤12) solution and allow to soak for 20 minutes. Use a softbristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush).

Page 6 of 10

2.

Remove the trays from the enzymatic or alkaline solution and rinse in purified water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.

3.

Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe.

4.

Carefully inspect each device to ensure that all visible contamination has been removed. If contamination is noted repeat the cleaning process.

G. Combination Cleaning and Disinfection Instructions for Instruments: NOTE: This section applies to Biomet 3i and Zimmer Dental instruments. 1.

Completely submerge the instruments in an enzyme or alkaline (pH ≤12) solution and allow to soak and sonicate for 10 minutes at 40-50 kHz. Use a soft nylon-bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft nylon-bristled brush (i.e. pipe cleaner).

2.

Remove instruments from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas.

3.

Place instruments in their appropriate locations in the Dental Wash Tray (ZBDWT01) and process through a standard instrument washer/disinfector cleaning cycle. An appropriate mesh basket can be used for the instruments that cannot be housed within Dental Wash Tray due to their size. The following minimum parameters are essential for thorough cleaning and disinfection.

Table 1: Typical U.S. Automated Washer/Disinfector Cycle for Surgical Instruments Step

Description

1

2 minute prewash with cold tap water

2

20 second enzyme spray with hot tap water

3

1 minute enzyme soak

4

15 second cold tap water rinse (X2)

5

2 minutes detergent wash with hot tap water (64-66 °C / 146-150 °F)

6

15 second hot tap water rinse

7

2 minute thermal rinse (80-93 °C / 176-200 °F)

8

10 second purified water rinse with optional lubricant (64-66 °C / 146-150 °F)

9

7 to 30 minute hot air dry (116 °C / 240 °F)

Table 2: Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step

Description

1

5 min pre-rinse with cold tap water

2

10 min alkaline cleaning agent wash at 55 °C

3

2 min rinse with neutralizer

4

1 min rinse with cold tap water

5

Disinfection at 93 °C with hot purified water until A0 3000 is reached (approx. 10 min)

6

40 min hot air drying at 110 °C

NOTE: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA approval, and validation according to ISO 15883) should be used.

H. Inspection for Wear and Damage: •

I.

Before each use, visually inspect all devices and trays/kits for completeness, damage and/or excessive wear (e.g. corrosion or rust build-up on the instrument surface, structural wear or damage, grommet presence or damage partial or complete fracture. Refer to the Reusable Lifespan Manual (ZBDINST0043) to provide the user information for identifying the end of life of the device. If damage or wear is noted that may compromise the function of the instrument or tray. DO NOT USE. Contact your Biomet 3i representative for replacement.

Wrapping Individual Instruments: Page 7 of 10

J.

•

Single devices should be packaged in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in the table below. Ensure that the pouch or wrap is large enough to contain the device without stressing the seals or tearing the pouch or wrap.

•

Standard medical grade, steam sterilization wrap may be used to package individual instruments. The package should be prepared using the AAMI double wrap or equivalent method.

•

NOTE: If sterilization wraps are used, they must be free of detergent residues. Reusable wraps are not recommended.

Wrapping Instruments Sets in Biomet 3i Trays and Cases: •

Re-assemble the surgical kit (tray) if necessary and place the cleaned instruments into specified locations. Areas designated for specific devices shall contain only devices specifically intended for these areas. Check for wear of the tray / kit before use. If the tray / kit has been damaged revert to directions in section I for the instrumentation to ensure proper sterilization is achieved.

•

Only devices manufactured and/or distributed by Biomet 3i should be included in Biomet 3i instrument trays. These validated reprocessing instructions are not applicable to Biomet 3i trays that include devices that are not manufactured and/or distributed by Biomet 3i.

•

Trays and cases with lids may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent.

•

Trays and cases with lids may also be placed in an approved sterilization container with gasket lid for sterilization. Follow the sterilization container manufacturer’s instructions for inserting and replacing sterilization filters in sterilization containers.

K. Steam Sterilization: Sterilize the kit and instruments at the recommended cycles noted in the following table. The recommended sterilization procedures have been validated by Biomet 3i.

Gravity Displacement Sterilizer (Full Cycle) Catalog Number (Kit)

15 Minutes

132°C to 135°C (270°F to 275°F) 30 Minute Dry Time

20 Minutes

132°C to 135°C (270°F to 275°F) 30 Minute Dry Time 30 Minute Cool Down

SGKIT, SGTIKIT NPSDK0, NCATD0, NCATD0C QNTSK20, QNTSK40, QNTSK40U X PSKT01, PSKT10, PSKT20, PSKT30, PSKT30U, PSKT35, X* PSKT40, PTT100, OST00, OST10, OST20, NTOST0, NTOST0A All Other Kits X Stand-alone Instruments X *NOTE: Requires an additional 30 Minute Cool Down for the indicated cycle.

40 Minutes

132°C to 135°C (270°F to 275°F) 30 Minute Dry Time 30 Minute Cool Down

X X

Pre-Vacuum Sterilizer (HI-VAC) 4 Minute, 4 Pulse

132°C to 135°C (270°F to 275°F) 30 Minute Dry Time

X* X X X X X

NOTE: The autoclave manufacturer’s instructions should be strictly adhered to for the pressure selection during the aforementioned sterilization cycles. The pressure requirements during the sterilization are the responsibility of the autoclave manufacturers to determine and validate. NOTE: Chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The sterilization parameters above can be achieved in both health care facility and larger, industrial sterilizer models. Because of the many variables involved in sterilization, each health care facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment, and use caution to avoid over-loading or stacking of trays. NOTE: The cleaning and sterilization information provided in this document have been validated as being capable of preparing instruments and kits for reuse. The sterilization validations demonstrated a sterility assurance level of 10-6. The sterilization parameters were validated with representative double wrapped worst case kits of the above catalog numbers containing all of the instruments included within the kits. Biomet 3i cannot guarantee the sterility when processing more than one kit at a time. NOTE: It remains the responsibility of the processor to ensure the processing is performed using validated equipment and that personnel in the processing facility have been trained to achieve the desired results. This normally requires validation and routine monitoring of the process. Any deviation by the processor from the instructions should be properly evaluated for

Page 8 of 10

effectiveness and potential adverse consequences. Some devices have specific disassembly/re-assembly instructions. In this case, refer to the instructions provided with the devices for additional instructions. Users must establish appropriate cleaning protocols for reusable medical devices used at their sites using the recommendations of the device manufacturer and cleaning agent manufacture.

L. Storage Instructions: •

Instruments should be dried completely prior to storage. Sterile, wrapped instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes. Failure to do so may result in stainless steel corrosion or staining.

•

Sterile instrument wraps should be carefully examined prior to opening to ensure that package integrity has not been compromised.

NOTE: Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, perforated, shows any evidence of tampering or has been exposed to moisture, the instrument set must be cleaned, repackaged and sterilized. NOTE: If there is any evidence that the lid seal or filters on a sterilization container have been opened or compromised, the sterile filters must be replaced and the instrument set re-sterilized.

M. Disposal Information: All used Biomet 3i implants and instruments are a potential biohazard, since they may be contaminated with blood or other body fluids, bone or other tissue. Handle and dispose these products in accordance with accepted medical practice and with applicable local, state and national laws and regulations. Any sharp objects should be disposed of immediately after use into a sharps container conforming to EN ISO 23907-1 or equivalent following the requirements in 2010/32/EU directive or equivalent national laws. The sharp edge must not be bent or broken and should be re-sheathed prior to disposal.

N. Reporting Problems: The user and/or patient should report any suspected serious incident related to the device by informing the manufacturer and the competent authority of the member state in which the serious incident has occurred. The instructions provided in this document have been validated by Biomet 3i in the laboratory and are capable of preparing reusable devices for use. It is the responsibility of the clinic or the hospital to ensure that cleaning, disinfection and sterilization are performed using the appropriate equipment and materials, and that personnel in the facility performing cleaning, disinfection and sterilization processes have been adequately trained in order to achieve the desired result. Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences. This material is intended for clinicians, professional health care and laboratory personnel and the Biomet 3i sales force only. The distribution to any other recipient is prohibited. This publication must not be used, copied or reproduced in whole or in part without the express written consent of Biomet 3i or its authorized representatives. ©2022 Biomet 3i LLC. All rights reserved.

Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454 Outside The U.S.: +1-561-776-6700 Fax: +1-561-776-1272 www.zimvie.com/en/dental.html

Biomet 3i Dental Iberica, S.L.U. WTC Almeda Park, Ed. 4, Planta 2 C/Tirso de Molina, 40 08940 – Cornellà de Llobregat (Barcelona) Spain Phone: +34 934 705 500 Fax: +34 933 717 849

: Medical Device

: Importer

: Date of Manufacture

: Batch code

: Catalogue number

: Caution

Page 9 of 10

: Do not re-sterilize

: Do not re-use

: Consult instructions for use or consult electronic instructions for use labeling.zimmerbiomet.com

: Sterilized using irradiation

: Use by date

: Do not use if package is damaged and consult instructions for use

: By prescription only

: Authorized representative in the European Community / European Union

: Manufacturer

: Non- sterile

: Single sterile barrier system

: Double sterile barrier system

: Single sterile barrier system with protective packaging inside

: Single sterile barrier system with protective packaging outside

: Contains hazardous substances

P-ZBDINSTRP Rev. E 2022-04

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