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Zimmer Biomet

BIOMET 3i Implant Removal Kit Instructions for Use

Revision Rev 22

ZIMMER BIOMET Dental Systems

10 Pages

IMPLANT REMOVAL KIT Distributed by:  USER GUIDE  Instructions for Use Includes instruments and tools to remove an implant   Procedure  Fixture Remover Screw  1... xpose the implant to be removed... insertion clockwise  2... elect a Fixture Remover Screw that corresponds to the specific implant (see “Compatibility List” in this pamphlet) and thread it into the implant clockwise using the Hexed Screw Driver (Fig... )... sing the Hexed Screw Driver (Table 1, Fig... ) and Torque Wrench (Fig... ), tighten the Fixture Remover Screw in a clockwise direction to 50-60Ncm by pulling on the thin torsion bar to the recommended torque (Table 2)... Fig...  Discard Fixture Remover Screw after use  Caution: Failure to tighten the Fixture Remover Screw to 50-60Ncm will damage the screw... ig...   Hexed Screw Driver (Table 1) Length (mm)  Product Name  7... 12... 17...  HDF 1607 HDF 1612 HDF 1617  Fig...   Fixture Remover Screw (Table 2) Fig...   Fixture Remover insertion counterclockwise Clamping Force  Clamping Force  Note: Screws in Fixture CLOCKWISE  Screw size M 1... M 1...  (not included in kit) M 1... M 1... No 1-72 UNF M 2... M 2...  Product Name FRS 14 FRS 154 FRS 16 FRS 18 FRS 172 FRS 20 FRS 25  Recommended Torque  Maximum Torque (Ncm)  50 50 60 60 60 60 60  60 60 80 100 100 100 100  Fig...  Do not exceed maximum torque  Fig...
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biomet_3i_implant_removal_kit_instructions_for_use_.pdf

Page 1

IMPLANT

REMOVAL KIT

Distributed by:

USER GUIDE

Instructions for Use

Includes instruments and tools

to remove an implant

Page 2

Procedure

Fixture Remover Screw

1. Expose the implant to be removed.

insertion

clockwise

2. Select a Fixture Remover Screw that corresponds to the

specific implant (see “Compatibility List” in this

pamphlet) and thread it into the implant clockwise

using the Hexed Screw Driver (Fig. 1).

3. Using the Hexed Screw Driver (Table 1, Fig. 2) and

Torque Wrench (Fig. 3), tighten the Fixture Remover

Screw in a clockwise direction to 50-60Ncm by pulling

on the thin torsion bar to the recommended torque

(Table 2).

Fig. 1

Discard Fixture Remover Screw

after use

Caution: Failure to tighten the Fixture Remover

Screw to 50-60Ncm will damage the screw.

Fig. 2

Hexed Screw Driver (Table 1)

Length (mm)

Product Name

7.0

12.0

17.0

HDF 1607

HDF 1612

HDF 1617

Fig. 3

Fixture Remover Screw (Table 2)

Fig. 4

Fixture Remover

insertion

counterclockwise

Clamping

Force

Clamping

Force

Note: Screws in Fixture CLOCKWISE

Screw size

M 1.4

M 1.54 (not included in kit)

M 1.6

M 1.8

No 1-72 UNF

M 2.0

M 2.5

Product Name

FRS 14

FRS 154

FRS 16

FRS 18

FRS 172

FRS 20

FRS 25

Recommended

Torque

Maximum

Torque (Ncm)

50

50

60

60

60

60

60

60

60

80

100

100

100

100

Fig. 5

Do not exceed maximum

torque

Fig. 6

Page 3

4. With the Fixture Remover Screw in place (Fig. 4), manually thread the Fixture Remover

(Fig. 5) onto the Fixture Remover Screw in a counterclockwise direction.

5. Using the Torque Wrench (Fig. 6), rotate the Fixture Remover counterclockwise until

the implant rotates by pulling on the thick torsion bar to the recommended torque (Table 3).

Caution: Do not exceed maximum torque. Use irrigation during the implant

removal process.

Fixture Remover (Table 3)

Note: Screws in

COUNTERCLOCKWISE

over

Fixture Remover

Screw

Fixture

Size

Length

(mm)

Fixture Remover

(Product Name)

Narrow

3.5

15.0

20.0

Regular

3.5

4.0

15.0

20.0

Wide

5.0

15.0

20.0

FR 415 or FR 420

Wide

6-8

15.0

20.0

FR 515 or FR 520

FR 315 or FR 320

FR 315 or FR 320

FR 415 or FR 420

FR 515 or FR 520

FR 615 or FR 620

Fixture Remover

Screw

FRS 14

FRS 16

FRS 18 / FRS 172

FRS 20

FRS 18 / FRS 172

FRS 20

FRS 18 / FRS 172

FRS 20

FRS 20

FRS 25

FRS 20

FRS 25

FRS 20

FRS 25

FRS 20

FRS 25

Recommended

Removing

Torque (Ncm)

200

250

300

350

300

350

300

350

350

400

350

400

350

400

350

400

Maximum

Removing

Torque (Ncm)

250

300

350

400

350

400

350

400

400

450

400

450

400

450

400

450

Torque Indicating Ratchet Wrench

Description

Product Name

Ratchet

Torque Control Device

6. If the implant does not turn at maximum

torque, remove the Fixture Remover and

relieve a minimum amount of coronal bone

around the implant using a Round Bur. Repeat

step 5.

7. After removing the implant (Fig 7) with the

Fixture Remover in place, grip the implant

firmly in a vise, (Fig. 8) and rotate the Fixture

Remover in a clockwise direction. Keep the

Fixture Remover.

8. Discard the implant and the attached

disposable Fixture Remover Screw.

FRCHT

TW 80400

Remove Implant

Thread of

implant

Fig. 1

remains

within

osteotomy.

Fig. 7

Fig. 8

Page 4

Torque Indicating Ratchet Wrench Assembly

Ratchet Arm

Torque Indicator Body

A

Spring Loaded Indicator Pin

B

C

A. Insert the Ratchet Arm into the large barrel opening of the Torque Indicator Body

B. Insert the narrow portion of the Spring Loaded Direction Indicator Pin into the opposite

end of the Ratchet Arm of the Torque indicator

C. Manually tighten the knurled knob clockwise to ensure the Ratchet Arm is secured to its

maximum insertion

Note: Pulling and turning on the Spring Loaded Direction Indicator will

provide desired clockwise or counter clockwise performance

Cleaning and Sterilization of the

Implant Removal Kit and Instruments

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, a standardized cleaning and sterilization protocol should be adopted.

The recommended cleaning and sterilization procedures in this document apply to the

Implant Removal Kit and the instruments housed within.

Warnings and Precautions

R DO NOT place used instruments back into the tray prior to proper cleaning per the

following procedure (Steps 1-7).

R Unless otherwise indicated, instrument kits are NOT sterile and must be thoroughly

cleaned and sterilized prior to use.

R Instruments should NOT be flash-autoclaved inside the instrument case.

Flash-autoclaving of individual instruments should be avoided.

R Unwrapped instrument cases DO NOT maintain sterility.

R The following procedures DO NOT apply to powered instrumentation.

R For the Torque (TW80400 and FRCHT) Indicating Ratchet Wrench, disassembly is

required.

Page 5

Recommended Procedures for Cleaning and Sterilization of

Implant Removal Instruments and Kit

Materials Required For Procedures

Solutions

R Neutral-pH detergent, or specialized cleaning solution

R Proteolytic enzyme detergent

R Ethyl alcohol (Ethanol); do not use rubbing alcohol (isopropyl alcohol)

R Tap water

R Distilled water

Tools

R PPE: Personal Protective Equipment (gloves, goggles, apron, etc.)

R Glass beakers

R Soft bristled brushes of various sizes

R Thin wire brush

R Autoclave-approved paper or bags

Equipment

R Ultrasonic cleaning unit

R Steam autoclave

Step-By-Step Instructions

Cleaning of Instruments

Note: Individuals who clean surgical instruments need to wear appropriate personal

protective equipment.

1. Following completion of a clinical surgical procedure, gather all instruments, prepare a

solution for soaking using tap water (tepid or lukewarm) and a neutral-pH detergent at

a dilution recommended by the detergent manufacturer. Place instruments in a single

layer at the bottom of a glass beaker containing the dilute solution. Soak the

instruments for at least ten (10) minutes.

Note: It is important to clean instruments as soon as possible; if immediate cleaning is

not possible, continue to soak the instruments to prevent blood from drying on the

surfaces.

Page 6

2. Rinse with running tap water for a minimum of two (2) minutes while brushing exteriors

of items individually with a soft bristled brush to remove visible debris; clean interior

lumens of specified instruments with small brushes.

3. Using a clean beaker, prepare a solution for ultrasonic cleaning using distilled water

with a specialized enzymatic detergent per the detergent manufacturer’s

recommendations.

4. Place all instruments in a single layer into the beaker of solution. Place the beaker

containing the instruments into the ultrasonic bath and turn on for five (5) minutes.

5. Remove each instrument and repeat the scrubbing procedure; ream lumens of

instruments having interior canals.

6. Rinse by flushing instruments for one (1) minute with a steady stream of running tap

water. Note: This step is important to prevent spotting.

7. Inspect each instrument visually and check for cleanliness, any remaining bone

fragments, visible soil or residual debris, and for visible damage and/or wear. Repeat

the scrubbing procedure as necessary. Set aside the instruments specific to the

Implant Removal Kit for packaging.

Cleaning of Implant Removal Kit

8. Detach the insert from the Implant Removal Tray. Scrub all surfaces of the tray and the

insert with mild soap using a soft bristled brush.

9. Rinse both pieces with running tap water for a minimum of two (2) minutes and inspect

surfaces for cleanliness.

10. Re-assemble the kit by placing the insert back into the tray and replacing the cleansed

instruments into specified grommets.

Packaging Kit for Sterilizer

11. Pour ethyl alcohol over the Implant Removal Tray, the lid, and onto the instruments to

rinse and remove residual soap and water minerals. Allow the instruments to dry

before wrapping.

12. Close the surgical kit and wrap it with autoclave paper twice, or place it within two (2)

autoclave-approved bags.

Page 7

Steam Sterilization per ANSI/AAMI ST79 Standard *

13. GRAVITY DISPLACEMENT STERILIZER (FULL CYCLE)

The exposure time is a minimum of fifteen (15) minutes at a temperature of 270 –

275ºF (132-135ºC).

– Or –

PRE-VACUUMED STERILIZER (HI-VAC)

The exposure time is a minimum of four (4) minutes, four (4) pulses at a temperature

of 270 – 275ºF (132-135ºC).

14. Post-sterilization drying time is a minimum of thirty (30) minutes.

Storage

15. Instruments should be dried completely and stored in a moisture-free environment.

Failure to do so may result in stainless steel corrosion or staining.

16. Prior to use, the exterior of each sterilized package should be inspected for integrity. If

a package is suspect, it should not be used and should be reprocessed as per the

above sterilization procedure.

17. Shelf life and sterility of wrapped instrument cases are dependent on storage in a

manner to avoid extreme temperature, moisture and/or other contamination. Care

must be exercised in the handling of wrapped cases to prevent damage to the sterile

barrier. The probability of an occurrence of contamination increases over time, with

handling, and based on the packaging method.

* The recommended sterilization procedures have been validated with the Implant

Removal Kit.

BIOMET 3i cannot control individual clinic handling procedures, cleaning methods,

bioburden levels and other conditions, and therefore assumes no responsibility for

sterilization of product by the user, even when the recommended guidelines above are

followed.

This material is intended for clinicians 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.

Page 8

Compatibility List for IMPLANT REMOVAL KIT

Implant system

Recommended

FRS screw size

Manufacturer: NOBEL BIOCARE®

Branemark System® MK lll Groovy NP Ø3.3mm

Branemark System MK lll Groovy RP Ø3.75mm

Branemark System MK lll Groovy RP Ø4.0mm

Branemark System MK lll Groovy WP Ø5.0mm

NobelSpeedy® System MK lll Groovy NP Ø3.3mm

NobelSpeedy System MK lll Groovy RP Ø4.0mm

NobelSpeedy System MK lll Groovy WP Ø5.0mm

NobelSpeedy System MK lll Groovy WP Ø6.0mm

NobelReplace® Straight Groovy NP Ø3.5mm

NobelReplace Straight Groovy RP Ø4.0mm

NobelReplace Straight Groovy WP Ø5.0mm

NobelSpeedy Replace NP Ø3.5mm

NobelSpeedy Replace RP Ø4.0mm

NobelSpeedy Replace WP Ø5.0mm

NobelSpeedy Replace 6.0 Ø6.0mm

NobelReplace Tapered NP Ø3.5mm

NobelReplace Tapered RP Ø4.3mm

NobelReplace Tapered WP Ø5.0mm

NobelReplace Tapered 6.0 Ø6.0mm

NobelActive® 3.5 Ø3.5mm

M1.6

M2.0

M2.0

M2.5

M1.6

M2.0

M2.5

M2.5

M1.8

M2.0

M2.0

M1.8

M2.0

M2.0

M2.0

M1.8

M2.0

M2.0

M2.0

M1.54

Manufacturer: STRAUMANN®

Standard Ø3.3 RN

Standard Ø4.1 RN

Standard Ø4.8 RN

Standard Ø4.8 WN

Standard Plus Ø3.3 NN

Standard Plus Ø3.3 RN

Standard Plus Ø4.1 RN

Standard Plus Ø4.8 RN

Standard Plus Ø4.8 WN

Tapered Effect Ø3.3 RN

Tapered Effect Ø4.1 RN

Tapered Effect Ø4.8 RN

Bone Level Implant Ø3.3 NC

Bone Level Implant Ø4.1 NC

Bone Level Implant Ø4.8 NC

M2.0

M2.0

M2.0

M2.0

M1.6 or M1.8 TRY IN

M2.0

M2.0

M2.0

M2.0

M2.0

M2.0

M2.0

M1.6 or M1.8 TRY IN

M1.6 or M1.8 TRY IN

M1.6 or M1.8 TRY IN

Page 9

Implant system

Recommended

FRS screw size

Manufacturer: BIOMET 3i

Certain® Internal Ø3.4

Certain Internal Ø4.1

Certain Internal Ø5.0

Certain Internal Ø6.0

External Ø3.4

External Ø4.1

External Ø5.0

External Ø5.0

M1.6 or M1.8 TRY IN

M1.6 or M1.8 TRY IN

M1.6 or M1.8 TRY IN

M1.6 or M1.8 TRY IN

M2.0

M2.0

M2.0

M2.0

Manufacturer: ASTRA TECH™

OsseoSpeed™ 3.0S

OsseoSpeed 3.5S

OsseoSpeed 4.0S

OsseoSpeed 4.5

OsseoSpeed 5.0

OsseoSpeed 5.0S

M1.4

M1.6

M1.6

M2.0

M2.0

M2.0

NOTE: For other Manufacturers not listed, the clinician is advised to complete a "try

in" by selecting a corresponding analog or implant to thread into whereby sequentially starting with the widest diameter FRS screw M2.5 followed by, in descending

order, the next available diameter. This will ensure compatibility.

Page 10

For more information,

please visit biomet3i.com

or contact your local BIOMET 3i

Sales Representative.

For additional languages, please visit

www.ifu.biomet3i.com

Distributed by:

Symbols

Used for

Catalog number

4555 Riverside Drive

Palm Beach Gardens, FL 33410

1-800-342-5454

Outside The U.S.: +1-561-776-6700

Fax: +1-561-776-1272

www.biomet3i.com

Batch code

Date of manufacture

Manufactured by:

e-space # 103, 104-1, 104-2, 105,

106, 205, 212, 312, 509, 510, 511,

10F, 36, 27 Gil, Digital-ro, Guro-gu,

SEOUL,152-789

Rep. of Korea

Tel.: 82-2-582-2885

Fax: 82-2-582-2883

www.neobiotech.co.kr

Made in Korea

Branemark System, NobelActive, NobelReplace and

NobelSpeedy are registered trademarks of Nobel Biocare. Nobel

Biocare is a registered trademark of Nobel Biocare Services AG.

Straumann is a registered trademark of Straumann Holding AG.

Astra Tech and Osseospeed are trademarks of Dentsply.

NeoBiotech is a tradmark of NEOBIOTECH CO., LTD.

Certain is a registered trademark and Providing Solutions - One

Patient At A Time and design are trademarks of BIOMET 3i LLC.

BIOMET 3i and design are trademarks of BIOMET, Inc.

© 2014 BIOMET 3i LLC. All rights reserved.

Consult Instructions

for Use

Non-Sterile

Manufacturer

Rx Only

EC REP

Caution: Law prohibits

dispensing without

prescription

Dongbang AcuPrime

1 Forrest Units,

Hennock Road East,

Marsh Barton,

Exeter EX2 8RU, UK

Tel : +44 1392-829500

(IRK: REV. 22 / 03-14)

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