Fixtures and surgical components

Fixtures and surgical components
Instructions for Use (IFU)
Fixtures and
surgical components
BioHelix Respect Internal Connection
R Ø4.3 and N Ø3.5
Fixture BioHelix™ Respect Internal
Fixture BioHelix™ Respect Internal Connection is an endosseus threaded dental implant indicated for fixed
single- and multiple unit dental rehabilitations.
The Fixtures proposed by Brånemark Integration AB are made of a high quality commercially pure titanium (CP)
offering extra high strength. The implant has two different surface textures for optimal osseointegration and
long-term stability in all clinical situations.
Place the Fixture with a maximum speed of 25 rpm or manually using a manual torque wrench. Do not place
the Fixture using a torque >45 Ncm. The drills are to be used with a maximum speed of 2.000 rpm.
Careful evaluation must be made before N Ø3.5 and R Ø4.3mm Fixtures are placed in the pre-molar or molar
region due to risk for mechanical overload, especially as single-unit restorations. Using N Ø3.5mm Fixture for
single-unit restoration in the molar region is not recommended.
Fixture Driver Internal
The installation of BioHelix™ Respect Internal Connection is performed using the Fixture Driver:
-
-
-
N and R-versions for use with N and R platforms, respectively.
Machine version, 28 and 37mm, to be used with surgical handpiece.
Manual versions, 23 and 32 mm, to be used with Manual Torque Wrench.
The Fixture Drive instruments shall be aligned axially towards the dodecagon (12 edged)
internal connection of the Fixture and pushed down in place. The exact engagement is
reached when the dodecagon upper part is at the same level as the Fixture platform level.
Note! In case the Fixture Driver is not connected correctly, the function of the Fixture and/or
the Fixture Driver can be damaged. Defect instruments shall not be used.
Cover screw and Healing abutment Internal
The Cover screw is co-packed under the fixture.
The Cover screw and Healing abutment is connected to the Fixture with a UGrip screw driver. After
the healing period the Cover screw/Healing abutment is removed and the permanent or temporary
fixed restoration is immediately inserted.
Note! Some versions of the Healing abutments are delivered non-sterile and should therefore be
sterilized before installation. See Cleaning and Sterilisation instructions.
MultiAbutment Internal
The MultiAbutment, made of Titanium, is indicated for multiple screw-retained prosthesis and exists in
Straight and Angled 17 and 30° versions for optimal esthetics.
The MultiAbutment is acting as an intermediate element between the Fixture platform level and the prosthetic reconstruction.
The Straight abutment is tightened using an external Hex 2.0 driver and Angled 17 and 30° versions using
a UGrip driver. Ensure that no soft tissue is clamped between Abutment and Fixture, it is recommended to
verify correct seating by x-ray.
2
Tighten the Abutment Straight using a prosthetic torque wrench to 25Ncm (N-Platform) or 32Ncm (R-Platform) and Abutment Angled 17 and 30° to 25Ncm (N and R-Platforms).
Note! Some versions of the MultiAbutments could be delivered non-sterile and should therefore be sterilized
before installation. See Cleaning and Sterilisation instructions.
Temporary Abutment Internal
The Temporary Abutment, made of Titanium, exists in Engaging on Fixture level for Single unit temporary
reconstructions and Non-engaging versions on Fixture and MultiAbutment level for multiple temporary
reconstructions.
Tighten the Temporary Abutment using a UGrip screw-driver, to the Fixture or MultiAbutment, with a prosthetic torque wrench to 25Ncm (N-Platform), 32Ncm (R-Platform) and 15Ncm (N/R-MultiAbutment Platform).
Note! The Temporary Abutments are delivered non-sterile and should therefore be sterilized before installation. See Cleaning and Sterilisation instructions.
Packaging and Labelling
The Fixture BioHelix™ Respect is protected and co-packed together with the cover screw in a double sterile
Label Printing data Fixture BioHelix Respect w Cover Screw N3.5mm Internal Connection
packaging. The sterile
Fixture and Cover screw is protected in a 006717
pure00titanium cylinder to avoid contact with
006597 00
other materials than pure titanium and the sterile titanium cylinder is protected in a peel-open blister.
Label Printing data Fixture BioHelixTitle
Respect w Cover Screw R4.3mm Internal Connection
Title
Doc No
Doc No
Rev
Rev
Label layout – Box Label
The peel-open blister
is packed together with 3 patient record labels.
Label layout – Box Label Layout sample
Printed sample
Printed sample
Note! The cover screw is co-packed
and placed under the fixture in the titanium cylinder.
Layout sample
INTEGRUM AB, Krokslätts Fabriker 50
431 37 Mölndal, SWEDEN
www.integrum.se
Brånemark Integration AB,
Fixture BioHelix™ Respect
Brånemark Integration AB,
Krokslätts Fabriker 50 Fixture BioHelix™ Respect
Internal Connection
Krokslätts Fabriker 50
Internal Connection
431 37 Mölndal, SWEDEN
Cover Screw
431 37 Mölndal, SWEDEN
www.branemarkintegration.com
Cover Screw
www.branemarkintegration.com
A1
R Ø4.3x13mm
92mm
A1
N Ø3.5x13mm
A
A
BBBB
X
REF5088
0086
OPRA
92mm
REF
nnnnnnnnnnYYYY-MM YYYY-MM
LOTXXXXXXX
LOT
X
BBBB
5082
006597_00
006717_00
0086
Fixture BioHelix™ Respect
R Ø4.3x13mm
Internal A1
49mm
Do not reuse
49mm
Use by (Expiry date)
Approved layout sample (signed by QA/RA)
Signed by (Name, Date)
Approved layout sample (signed by QA/RA)
Approved printed sample (signed by QA/RA)
Signed by (Name, Date)
Signed by (Name, Date)
Approved printed sample (signed by QA/RA)
Signed by (Name, Date)
Batch code
Niklas Hovferberg, QA/RA
Niklas Hovferberg, QA/RA
IXXXX
SN
BBBB
5082
REF 1288
Fixture BioHelix™ Respect
Internal A1
N Ø3.5x13mm
BBBB
5088
Axor II
nnnnnnnnnn YYYY-MMYYYY-MM
XXXXXXX
Niklas Hovferberg, QA/RA
Niklas Hovferberg, QA/RA
Document Template: 000 010-01
0086
LOT
XXXXX
CE mark
N
Fixture platform, N = Narrow
R
Fixture platform, R = Regular
2 (3)
This document is the above-mentioned company's property and must not be copied, shown or passed on to third parties without
the company's written consent.
2 (3)
Sterilized using irradiation
Screw Driver Grip: External Hex 2.0
Catalogue number/ Article reference number
Screw Driver Grip: UGrip
Caution, see Instructions For Use
Document Template: 000 010-01
This document is the above-mentioned company's property and must not be copied, shown or passed on to third parties without
the company's written consent.
3
System overview
BioHelix Respect Internal Connection R Ø4.3 and N Ø3.5
The Fixture BioHelix™ Respect Internal Connection assortment from Brånemark Integration AB comprises
the following product groups.
1. Twist drills – for the preparation of the osteotomy prior to implant installation, delivered non-sterile
and intended for multiple use.
2.Fixtures – for installation in the jawbone to provide anchorage for dental prosthetic reconstruction.
The system consists of Fixtures in 2 diameters with 2 prosthetic platforms/interfaces.
(N = Narrow and R = Regular) and several lengths.
D
E
B
C
A
Thread Diameter
Length
Apex diameter
Platform diameter
Platform
A
B
C
D
E
N
Ø3.5 mm
10, 13, 15mm
2.1 mm
Ø3.5mm
N
R
Ø4.3 mm
7, 8.5, 10, 11.5, 13, 15 mm
2.8 mm
Ø4.3mm
R
3. Cover screw / Abutment options during surgery:
4
a. Cover Screw – to protect the Fixture from bone overgrowth during healing. Covered by the mucosa.
b. Healing Abutment – to protect the Fixture from bone overgrowth during healing and provide
a passage through the mucosa.
c. MultiAbutment – to be placed on the fixture as a permanent abutment and anchorage
for the dental prosthesis.
d. Temporary Abutment – to be placed on the Fixture or MultiAbutment as a temporary anchorage
for a temporary dental prosthesis.
4. Surgical instruments – Surgical torque wrench, Screw and/or Fixture drivers for the installation of
Fixtures and abutments. Drill extension, Drill depth gauge and Direction indicators to facilitate
alignment during the drilling procedure.
Drill protocol BioHelix Respect Internal
The drill protocol shall be chosen so that the osteotomy is adapted to the bone quality/density and the Fixture
so that an optimal primary stability is reached.
Twist drill w. tip Ø2.0
Pilot drill
N
R
Ø3.5
Ø4.3
Final drill Ø
Ø2.0
Ø3.15
Ø2.85
Ø3.35
Soft spongeous bone
Fixture Diameter
Ø3.15
Ø3.85
Medium dense bone
Dense cortical bone
Bone quality
Soft
Medium
Dense
N
Ø3.5 mm
Twist drill w Tip Ø2.0
Twist drill w Tip Ø2.0
Twist drill Ø2.85
Twist drill w Tip Ø2.0
Twist drill Ø3.15
R
Ø4.3 mm
Twist drill w Tip Ø2.0
Twist drill Ø3.15
Twist drill w Tip Ø2.0
Twist drill Ø3.0
Twist drill Ø3.35
Twist drill w Tip Ø2.0
Twist drill Ø3.0
Twist drill Ø3.35
Twist drill Ø3.85
Note!
The Pilot drill may be used as an optional step after Twist drill w tip Ø2.0. In situations with extreme dense cortical bone a
Twist drill with larger diameter than the final Twist drill may be used to penetrate the cortex only.
5
Handling instruction per product category
Drills
The drills are made of stainless steel and marked with diameter and depths according to the picture below. The
drills are to be used with a maximum speed of 2.000 rpm.
All drilling are to be performed intermittently and using profuse irrigation to prevent overheating.
When placing the longer Fixtures, make sure the drilling hole is prepared to the correct length before placing
the fixture using a depth gauge.
Twist drill
w tip Ø2.0
Pilot drill
Twist drill
15 mm
13 mm
10 mm
1.2 mm
7 mm
10 mm
9.6 mm
0.4 mm
Note!
Twist drills are 0.4mm longer than the Fixture. Consider the drill depth when drilling near vital anatomical structures.
Always allow an extra 3mm safety margin in bone height in order to avoid critical structures as nerves and blood vessels etc.
Cleaning and sterilization
Prior to use in the patient’s mouth, the non-sterile devices must be cleaned in alkaline based detergent,
washed and rinsed with water in a dishwasher and sterilized in a gravity-fed moist heat autoclave. The device
must be sealed in a sterilization wrap appropriate for the given parameters and sterilized at 135ºC in 5 minutes. If ultrasonic cleaning is used, the twist drills should be separated from each other in the ultrasonic bath
in order not to damage the cutting edges and thereby reduce the bone cutting capacity.
Note! Please note that the Surgical Tray is indicated for storage only, not as a holder during sterilization.
6
Surgical notes
The basic principles as defined by Professor Per-Ingvar Brånemark et al. and further developed and refined
in the literature on dental osseointegration shall be used throughout the surgery. Any user using the product
from Brånemark Integration AB must be thoroughly trained in these principles and in oral surgery.
Perform the surgical procedure in sterile conditions and with an atraumatic surgical technique using profuse
saline irrigation to minimize the risk for overheating of bone.
Always allow an extra 3mm safety margin in bone height in order to avoid critical structures as nerves and
blood vessels etc.
Brånemark Integration AB recommends the use of a 2-stage procedure with an intervening healing period of
(normally) 3 months for the lower jaw, and 6 months for the upper jaw, respectively.
Place the Fixture using a surgical handpieace with a maximum speed of 25 rpm or manually using a Manual
Torque Wrench. Do not place the Fixture using a torque >45 Ncm.
Warnings, risks and contraindications
General warnings
The description given is insufficient to allow immediate use of Brånemark Integration AB devices without
previous experience in dental implant surgery. It is
therefore strongly recommended to obtain and regularly update education and training in oral implantology prior to use these devices.
Always perform careful clinical and radiological examination prior to treatment. Special attention has to
be given with respect to patients’ medical history, anatomical situation and possibility to fulfil the patients’
expectations of treatment outcome.
100% success can never be guaranteed.
Do not use if product package is broken or the expiry
date on the label is exceeded. The expiration date is
marked on the product package box label.
Sterile product may not be re-sterilized and/or reused.
Risks and contraindications
General oral surgery contraindications apply.
Treatment of growing children is not recommended.
Previous radiotherapy, diabetes mellitus, anti-coagulation therapy, bruxism, diseases of the temporomandibular joint, pathologic diseases of the jaw and
mucous membranes, acute or chronic infections,
treatment with cytotoxic drugs and titanium allergy,
poor oral hygiene, heavy smoking or other medical
conditions such as certain systematic disorders
should be addressed when considering the therapy.
General dental implant surgical risks applies, including
fatigue fixture fracture, fixture failure, numbness pain,
localised swelling, edema, hematoma, or bleeding.
Only use together with components and instruments
from Brånemark Integration AB.
A screw or instrument must always be entered
aligned with the female threads, otherwise there will
be risks of damaging the threads.
When using Brånemark Integration AB’s products,
always take measures to prevent them from being
inhaled or ingested.
Careful evaluation must be made before N Ø3.5mm
and R Ø4.3mm Fixtures are placed in the pre-molar
or molar region due to risk for mechanical overload,
especially as single-unit restorations. Using
N Ø3.5mm Fixtures in molar regions is not
recommended.
Disclaimer of Liability: Brånemark Integration AB disclaims any liability expressed or implied, and shall have
no responsibility for any direct, indirect, punitive or other damages, arising out of or in connection with any
errors in professional judgement or practice in the use or installation of the fixture.
7
Please contact:
Brånemark Integration AB
Krokslätts Fabriker 50 | SE-431 37 Mölndal, Sweden
Phone +46 31 760 10 60 | Fax +46 31 15 52 60
info@branemarkintegration.se | www.branemarkintegration.se
0086
Doc.No: 007 000 rev 01, June 2016
Copyright © Brånemark Integration AB
Production: mkmedia
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