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)