Anthogyr 063INSTRU_NOT Instruments Instruction Manual
- August 16, 2024
- Anthogyr
Table of Contents
063INSTRU_NOT Instruments
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Specifications:
- Validity Date: 2024-01
- REF: 063INSTRU_NOT
- SAP code: 063INSTRU_NOT_US Index: G
- Materials: Titanium (Ti6Al4V ELI), Stainless steel,
Polyetheretherketone (PEEK), Silicone, or PVC
Product Information:
The Anthogyr instruments are designed for planning, implant bed
preparation, and placement of implants or prostheses from the
Anthogyr implant systems for oral implantation. The instruments are
made of high-quality materials such as Titanium, Stainless steel,
Polyetheretherketone (PEEK), Silicone, or PVC.
Intended Use:
The Anthogyr instruments are intended for various purposes:
-
Planning: X-ray templates for planning prior
to implant placement. -
Implant bed preparation: Instruments for
preparing the implant bed. -
Auxiliaries instruments: For visual control or
guidance during implant bed preparation or placement. -
Torque transmission instruments: For applying
or transmitting torque. -
Gripper components: For manipulation of screws
or prosthetic components.
Indications for Use:
The Anthogyr instruments are indicated for use in procedures to
place implants or prostheses in fully or partially edentulous
patients. Specific indications include visual control, guidance of
implant position, depth, and direction, and manual manipulation of
prosthetic components.
Product Usage Instructions:
1. Planning and Implant Bed Preparation:
Use X-ray templates for planning and select appropriate cutting
instruments for implant bed preparation according to the specific
procedure requirements.
2. Implant Placement:
Utilize auxiliaries instruments such as drill guides and sleeves
for visual control and guidance during implant placement. Ensure
proper torque transmission using the designated instruments.
3. Gripper Component Usage:
For manual manipulation of screws or prosthetic components, use
the gripper components provided with the Anthogyr instruments.
FAQ:
Q: What materials are the Anthogyr instruments made of?
A: The instruments are made of Titanium (Ti6Al4V ELI), Stainless
steel, Polyetheretherketone (PEEK), Silicone, or PVC.
Q: What is the intended use of the gripper components?
A: Gripping instruments are intended for the manipulation of
screws, prosthetic components or analogs.
“`
us Instructions for Use Anthogyr instruments Valid only in the United States
Anthogyr
www.anthogyr.com
Validity Date: 2024-01
0459
2237 Av. André Lasquin
E-mail: contact@anthogyr.com
REF: 063INSTRU_NOT
74700 Sallanches France
Phone: +33(0)4 50 58 02 37
SAP code: 063INSTRU_NOT_US Index: G
Anthogyr instruments Instructions for use for standard or guided surgery
instruments used with
the Axiom® BL Valid only in the United States
Table of Contents
1. Instructions for use for Anthogyr instruments
……………………………………………………………………………………………………………………2 2. Instructions for use for
Anthogyr Surgical and prosthetic cassettes………………………………………………………………………………………7
Appendix 1 Flow chart of cleaning and sterilization
process…………………………………………………………………………………………………11 Appendix 2 Disassembly of the
Anthogyr Cassettes …………………………………………………………………………………………………………….12 Appendix 3
Disassembly of INTEGRAL guided Surgery
Cassettes…………………………………………………………………………………………..13 Appendix 4 Storage of the
instruments in the cassette in sales configuration
………………………………………………………………………..14
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us Instructions for Use Anthogyr instruments Valid only in the United States
1. Instructions for use for Anthogyr instruments
Caution: U.S. federal law restricts this device to sale by or on the order of a dental professional.
1.1 Product description
Figure 1
1. Axiom® initial drill 2. Axiom® gauge 3. Axiom® step drill 4. Cortical
drill
Anthogyr instruments are part of the Anthogyr Axiom® implant systems and are
divided into types according to use:
Planning: X-ray templates Implant bed preparation:
Guided cutting instruments: initial drills, step drills, pointer drills, taps,
gingival cutters, bone mill, cortical bur. Non-guided cutting instruments:
initial drills, step drills, pointer drills, taps, gingival cutters, burs.
Auxiliaries instruments: gauges, drill guides, drill
stops, sliders/spoons, implant fixation screws, pins, sleeves.
Torque transmission instruments: mandrel,
wrench, implant holder, mandrel extension.
Gripper components: gripper, gripping wrench,
handling analog.
For a detailed product description, item reference number and dimensions,
please consult the product label and the Anthogyr product catalogue.
For detailed information on the instruments, their specific indications for
use, their use in specific procedures and their compatibility, please refer to
the user manuals and brochures listed in the “Further Information” section.
Materials: Instruments are made of Titanium (Ti6Al4V ELI), Stainless steel,
Polyetheretherketone (PEEK), Silicone, or PVC.
1.2 Intended use
Anthogyr instruments are intended for the planning and the implant bed
preparation, or for the placement of implants or prostheses from the Anthogyr
implants systems for oral implantation.
Specific intended use: Planning X-ray templates are intended to facilitate the
planning prior to the placement of Anthogyr implants. Implant bed preparation
Implant site preparation instruments are intended to prepare the implant bed
prior to implant placement.
Auxiliaries instruments Auxiliaries instruments are intended for visual
control or physical guidance during the implant bed preparation or implant
placement.
Torque transmission Tightening instruments are intended to apply or transmit
torque to instruments, implants or prostheses.
Gripper components Gripping instruments are intended for the manipulation of
screws, prosthetic components or analogs.
1.3 Indications for use
Anthogyr instruments are indicated for use in procedures to place implants or
prostheses, from the Anthogyr implant systems, in fully or partially
edentulous patients.
Specific indications for use Planning The X-ray templates represent the
dimensions of the implants and provide guidance in the choice of the device to
be placed, in accordance with the bone volume available. Implant bed
preparation Cutting instruments are indicated for use in implant surgery to
drill or cut into the upper or lower jaw and can be used to prepare bone and
soft tissue. Guided cutting instruments are used with the corresponding guided
surgical auxiliaries to ensure better control of the direction and depth of
cut.
Auxiliaries instruments Depth gauges, drill stops, position and drill guides,
guided surgery drilling template, guided surgery sleeves are used during
implant bed preparation or implant placement and are indicated for visual
control or physical guidance of the position, depth and direction of the
implant channel or implant.
Torque transmission instruments Screwing instruments are used to transport in
the mouth instruments, implants or prosthetic devices and allow to transmit
torque. They can be used with a ratchet or handpiece.
Gripper components Gripping instruments are used to manually transport
prosthetic components or analogs.
1.4 Patient type and intended user
Anthogyr instruments are intended for use with partially or totally edentulous
adult patients who do not present any of the conditions listed among the
contraindications.
Anthogyr instruments are reserved for use by dental surgeons trained in
implantology.
1.5 Contraindications
Allergy or hypersensitivity to chemical components in the materials used and
mentioned in the “Product description” section.
1.6 Warning Products must be protected against inhalation or
swallowing when handled in the mouth. Aspiration of products can lead to
infection or incidental physical injury.
Do not use damaged, corroded or dull instruments.
Always inspect instruments before use.
Do not exceed the maximum number of uses for
the device as detailed in the “Lifespan of products”
section.
Avoid the area of the mandibular nerve canal
during the implant bed preparation and the insertion of the implant. Nerve
damage can lead to anaesthesia, paraesthesia and dysaesthesia.
Do not exceed the recommended insertion torques
as this may cause bone necrosis and fracture.
Specific warnings
X-ray templates
The precision of the X-ray template is +/- 2%. To avoid scaling errors, X-ray
templates must not
be copied.
Use the implant-specific X-ray template. Do not use a damaged X-ray template
(altered
print, tear etc.). Implant bed preparation
Due to the design and function of the drills, the tip
is a maximum of 0.5 mm longer than the insertion depth of the implant. This
additional length should be taken into account in the planning phase and is
represented by triangles on the X-ray template.
Ensure that the drilling depth is correct by using
the recommended surgical plans (including X-ray evaluation), depth marks on
the drills, drill stops, depth gauges. Anthogyr instruments have depth
markings that correspond to the available implant
lengths (Figure 1).
When measuring the depth of the implant channel,
ensure that the depth gauge is inserted to the full depth of the drilling.
Use the drills in order of increasing diameter with
a clockwise rotation.
Drill intermittently using external irrigation.
Bone quality must be taken into account when preparing the implant bed.
2/17
us Instructions for Use Anthogyr instruments Valid only in the United States
Do not exceed the following cutting speeds:
Surgical stage
Cutting instrument
Preparation of the gum, guided and
non-guided
Gingival cutter
Preparation of the alveolar crest,
non-guided
Pointer drill Round bur Lindemann bur
Preparation of the alveolar crest,
guided
Integral pointer drill First Drill pointer drill
Axiom® initial drills
Drill, guided and non-guided
First Drill initial drills Integral initial drills Axiom® step drills
Axiom® cortical drills
Preparation of the bone crest post- Axiom® BL countersink drilling, non-guided
Tapping, guided and Axiom® tap non-guided
Speed (rpm)
50
1500 1500 1500 1000 1500 1500 1500 1000 1000 1000
50
25
Drill for pin:
Please note that 0.5 mm of apical over-drilling must
be accounted for.
Guided surgical instruments:
When inserting or removing a drill bit from a sleeve,
the drill bit must not be in a rotated position. This could result in damage
to the drill bit and/or guiding sleeve, and potentially lead to a blockage.
The guided drills may only be used in combination
with the corresponding sleeves and/or spoons inserted into the guides. Inspect
the drill sleeves for operational safety before each surgical procedure.
Inspect the adjustment, orientation and stability of the guide sleeves in
their housing, as well as the placement of the guide before each surgical
procedure.
Ensure that the spoon is correctly positioned inside
the sleeve inserted in the drilling guide.
To insert a fixation pin, place the guide (on teeth
or mucous membranes), create the pin housing by drilling with the
corresponding drill bit in the corresponding sleeve up to the stop, insert and
screw the pin into the sleeve.
Avoid applying a radial load to the sleeves to ensure
that they are properly retained in the drilling guide. The First Drill guided
surgery protocol is not applicable to the preparation of implant sites for
Axiom® implants with a diameter greater than 4.6mm and a
length greater than 14mm.
The Integral guided surgery protocol is not applicable to the preparation of
implant sites for Axiom® implants with a diameter greater than 4.6 mm and a
length greater than 14 mm.
Axiom® BL countersinks: Ensure that the primary stability of the Axiom® BL implants is sufficient before using the countersinks. Throughout the entire rotation, maintain the alignment axis of the bur and the pin: do not exert any bending force on the tool.
Auxiliaries instruments The pointer drill Ø1.5 mm (Ref. OPPO15) is not recommended for use without a ring or drilling guide.
Torque transmission Do not exceed the following tightening speeds:
Surgical stage
Associated implant Speed (rpm)
Tightening of the
Axiom® PX implant
15
implant, guided and
non-guided
Axiom® X3 implant
15
Axiom® implant screwing instruments:
The Axiom® BL implant screwing wrenches and
mandrels have a graduated marker for the vertical positioning of the implant
against anatomical structures or to the bone in the case of flapless
placement.
The Axiom® BL implant screwing wrenches and
mandrels have 3 sides, each with a visual marker corresponding to a side of
the trilobate connection of the implant. At the end of screwing process,
orient one of the markers as closely as possible in the appropriate direction,
depending on the desired prosthetic restoration and the situation
in the mouth.
Prosthesis screwing instruments:
Do not use motorized rotating tools to screw/
unscrew prosthetic parts.
Excessive pre-drilling with AATOOL instrument may
result in breakage of the instrument.
Do not apply bending forces to spherical instru-
ments.
1.7 Caution/Precaution Clinical use: The components must be handled in
accordance
with the instructions detailed in the manual of the implant range, listed in
the “Further information”
section.
Ensure that all handling is sterile.
Inspect the instruments before use. Never use potentially contaminated
components. Only use properly reprocessed instruments if they are suitable for
multiple uses.
Handle cutting instruments with care to avoid
injury.
Every time an instrument is changed, check its
proper hold in the contra-angle or wrench by pulling on it slightly.
Guided surgical sleeves, the analog positioning
tool and Angulated Access screw gripper are for single use only: do not reuse
or re-sterilise. Risk of contamination and risk of altering the functional
surfaces.
Specific caution/precautions Planning During the surgical planning phase, ensure the proper use of an X-ray transparency in good condition.
Implant bed preparation
Inspect the instruments before use. Always follow
the recommended drilling speeds.
To ensure proper drilling and alignment, use drill
stops, drill guides and depth gauges.
Taps should only be used in D1 bone.
Torque transmission
Inspect the instruments before use. Use tools that are compatible with the
system, for
more information see the “Compatibility information” section. Component rework
The component must not be retouched in any way.
1.8 Residual risks and side effects
The clinical outcome of dental treatment is influenced by multiple factors.
The following residual risks and possible side effects are related to the use
of the instruments and may lead to additional dental treatment at the dental
practice:
Residual risks: additional treatment at dentist’s office
bite/mastication/phonetic problems bleeding bone compression bone damage
damage to adjacent/opposing tooth discomfort hyperplasia
hypersensitivity/allergic reaction injuries of gingiva irritation/inflammation
local or systemic infection (including peri-implan-
titis, periodontitis, gingivitis, fistula)
local pain longer recovery/healing time than expected loss of implant loss of
prosthetic component nerve damage possibly resulting in chronic pain
paraesthesia, dysaesthesia poor aesthetic outcome possibility of prolongation
of surgery possibility of surgical implant explantation possibility to
swallow/inhale small parts during
the procedure
recall to the dentist’s office sinus perforation swelling
Side effects: swelling local inflammation bruising resorption of
maxillary/mandibular ridge bone local infection minor bleeding
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us Instructions for Use Anthogyr instruments Valid only in the United States
1.9 Compatibility information
Anthogyr implants and prosthetic components are available in a wide variety of
configurations. Only Anthogyr parts that are compatible with the implant
connection are suitable for use. For more information, please refer to the
manuals listed in the “Further information” section.
Compatibility of instruments for implant bed preparation: Anthogyr implant bed
preparation instruments are equipped with a coloured ring indicating the
drilling diameter. They are in line with the diameters of the implants. The
drilling diameter is also marked on the
instrument.
Ring colour Range
Green
Axiom®
Red
Axiom®
Yellow
Axiom®
White
Axiom®
Blue Purple
Axiom® Axiom®
Brown
Axiom®
Drilling diameter Tap diameter
Ø2.4
/
Ø3.0
Ø3.4
Ø3.6
Ø4.0
Ø4.2
Ø4.6
Ø4.8
Ø5.2
Ø5.4
/
Ø6.0
/
The cortical drills are differentiated from other instruments by two black lines laser marked.
Compatibility of the Axiom® implant screwing instruments:
Marker
Compatible implant types
Grey instruments
Axiom® BL implant
Warning: The use of instruments that are not suitable for the implant can
damage the implant connection. The grey instruments are intended for use with
Axiom® BL implants. Anthogyr cassettes contain gold screwing instruments which
are part of Axiom® TL system (for information, Axiom® TL implants are not
registered in United States).
Compatibility of the prosthetic tightening
instruments:
Marker “HEXA” marking “BALL” marking
Compatible component types Screw with hexagonal recess Screw with ball recess
Compatibility of the Integral range guided surgical instruments:
Each guided instrument is guided in only one sleeve
diameter. A coloured dot on the instrument indicates the compatible sleeve. The colour of the dot is identical to the colour of the sleeve.
Marker
Compatible
Instruments with a blue dot
Sleeve Ø3.6
Instruments with a purple dot
Sleeve Ø4.2
Instruments with a brown dot
Sleeve Ø5.0
Compatibility of drill and bur stops:
Components
Compatible instrument types
Lindemann bur
Pink Axiom® stops
Axiom® initial drills Axiom® Ø2.0/2.4 and Ø2.4/3.0 step
drills
Yellow Axiom® stops Axiom® Ø3.0/3.6 step drills
Grey Axiom® stops Axiom® Ø3.6/4.2 step drills
Blue Axiom® stops Axiom® Ø4.2/4.8 step drills
Purple Axiom® stops Axiom® Ø4.8/5.4 step drills
Brown Axiom® stops Axiom® Ø5.4/6.0 step drills
Stop pin (Ref.OPFFP)
Axiom® BL Ø4.5, Ø5.3 and Ø6.6 countersinks
Compatibility of the INGPPA drilling guide: The drilling guide (Ref. INGPPA)
is only compatible with Axiom® BL implants. The drilling guide is only
compatible with the Ø1.5 mm pointer drill (Ref. OPPO15).
1.10 Cleaning and disinfection
Point-of-Use: Never let surgical residues (blood, secretion, tissue residues)
dry on an instrument, clean immediately after surgery. The instruments that go
in the cassette are sold included in the cassette or separately. A flow chart
to summarize the cleaning process is available in appendix 1.
Anthogyr instruments are delivered non-sterile. They must be cleaned and
decontaminated before use and after each use for reusable components (except
X-ray templates). Do not use the components if the packaging is opened or
damaged. Before treatment, remove the components from their packaging. Before
every use, the device must be carefully checked for proper function and
damage. If applicable, for cleaning, the device must be disassembled. Anthogyr
recommends following the protocol described below. Remove the instruments from
the tray and clean separately.
Manual cleaning
Cleaning
1. Thoroughly clean the devices with the following steps.
2. Brush meticulously all surfaces with a soft brush (example: nylon) under
tap water at room temperature for at least 1 minute. Use an adapted soft-nylon
brush to each lumen or hole at least one time.
3. Completely submerge in a detergent and disinfectant solution for at least
5 minutes following the manufacturer’s instructions temperature, and
concentration (paragraph below). Flush each lumen or hole with detergent
solution at least one time.
4. Whilst immersed, brush meticulously all surfaces with a soft brush
(example: nylon) for at least 1 minute or until there is no visible trace of
con-
taminants. Use an adapted soft nylon brush to each lumen or hole for 20
seconds.
5. During immersion, move the devices by making 3 back and forth movements.
Rinsing and drying
6. Rinse with critical water (per AAMI TIR34) for at
least 1 minute.
7. During rinsing, brush meticulously all surfaces with a soft brush
(example: nylon) for at least 30 seconds using an adapted nylon brush to hard-
reach
areas.
Flush each lumen or hole with tap water at least one time. 8. Rinse with
critical water (per AAMI TIR34) at room temperature for at least 1 minute. A
visual inspection, an inspection end point on the instrument. If the user sees
visual contamination on the cassette, he must restart the cleaning process.
Products and detergents
Anthogyr used the following products and detergents to approve the various
protocols. However, other products and detergents may be used according to
local availability. Approval of these products is the responsibility of the
user. Cidezyme (ASP) at a concentration of 8mL/L.
For sterilization, see the “Sterilization” section.
Automated cleaning
Manual pre-cleaning
1. Thoroughly clean the devices with the following steps.
2. Soak the device in a detergent and disinfectant solution for at least 5
minutes following the manufacturer’s instructions, temperature, and
concentration (paragraph below).
3. Whilst immersed, brush all surfaces of the test article for at least 30
seconds using a soft nylon bristle. For each lumen or hole, use an adapted
soft nylon brush during 30 secondes.
Automatic cleaning
1. Pre-wash with cold tap water (<45°C) for 2 min. 2. Wash at heated water
(50-60°C) C for 5 min with
an enzymatic detergent (paragraph below). 3. Neutralization at heated water
(50-60°C) for 1 min
with an appropriate neutralizer (paragraph below). 4. Intermediate rinsing at
cold water (<45°C) for
1 min.
5. Thermal rinsing at 90°C for 5 min with critical water (per AAMI TIR34).
6. Drying at 60°C for 10 min. 7. A visual inspection, an inspection end point
on the
instrument. If the user sees visual contamination on the cassette, he must
restart the cleaning process.
PRODUCTS AND DETERGENTS
Manual pre-cleaning
Cidezyme (ASP) at a concentration of 8mL/L. Automatic cleaning Enzymatic
detergent: Neodisher Mediclean Dental
(DrWeigert) at a concentration of 2mL/L. Neutraliser: Neodisher Z Dental
(DrWeigert) at a
concentration of 1mL/L. After cleaning, check all instruments for corrosion,
visible dirt, damaged surfaces, blunt cutting edges, chipping and
contamination. Critical areas such as handle structures, joints or holes must
be inspected carefully.
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us Instructions for Use Anthogyr instruments Valid only in the United States
Instruments with illegible markings/labelling must be replaced. For sterilisation, see the “Sterilisation” section.
1.11 Function test
Process contaminated instruments and remove
damaged instruments. Damaged instruments must be cleaned and disposed of
separately. After cleaning, check all instruments for corrosion, visible dirt,
damaged surfaces, blunt cutting edges, chipping and contamination. Critical
areas such as holes must be inspected carefully. Instruments with illegible
markings/labelling must be replaced. Before every use, the device must be
carefully checked for proper functioning and damage. For USA – Configuration:
Wrapped in two layers of Halyard Health (H200-510(k) K082554) polypropylene
wrap using simultaneous envelope folding techniques.
1.12 Sterilisation
Anthogyr instruments delivered non-sterile must
be sterilised before use (except X-ray templates). Anthogyr recommends
following the protocol described below: Users should ensure that the
sterilizer and all sterilization accessories (sterilization wraps, pouches,
sterilization trays, biological indicators and chemical indicators) are
cleared by the FDA for the intended sterilization cycle. ATTENTION: This
product cannot be autoclaved in its original packaging.
Grouping name Method
Conditions
Drying Time
For the United States:
Anthogyr
Surgical and Prosthetic Cassette
Moist Heat (Autoclave) Pre-vacuum
132°C (270°F) for 4 min
20 min2
INTEGRAL
Guided Surgery Cassette
Moist Heat (Autoclave) Pre-vacuum
132°C (270°F) for 4 min
30 min2
2 Nevertheless, a drying time shorter than defined time cannot be applied.
After the sterilisation was done, asepsis rules must be followed.
1.13 Protocol for use
Refer to the brochures listed in the “Further information” section for
detailed step-by-step instructions. Anthogyr instruments are devices intended
for temporary use in the oral cavity and intended for continuous use for less
than 60 minutes.
1.14 Lifespan of products:
Planning X-ray templates can be used for up to 5 years unless the information
is illegible.
Implant bed preparation The instruments can be reused in accordance with the maximum number of uses defined in the table below, except in cases where there are signs of deterioration
(illegibility of markings or markers, deterioration of the coating, signs of corrosion, etc.).
Range
Type of device Ø2.0 pin drill
First Drill
Pointer drills Initial drills Ø2.0 pin drill Gingival cutters
Integral
Bone mill Cortical bur
Pointer drills Initial drills Step drills Taps Countersinks
Axiom® Multi Level®
Pointer drills Round bur Lindemann bur Initial drills Step drills Cortical drills Taps
Product lifespan 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 10 uses 20 uses 20 uses 20 uses 20 uses 20 uses 20 uses 20 uses 20 uses
One use is equivalent to one implant channel.
Auxiliaries instruments The instruments can be reused in accordance with the maximum number of uses defined in the table below, except in cases where there are signs of deterioration (illegibility of markings or markers, deterioration of the coating, signs of corrosion, etc.).
Range
Type of device
First Drill and Ø2.0 fixation pin Integral guided
surgery
Axiom® Multi Level®
Sleeves Drill stops Guiding pin Gauges
Product lifespan 250 uses, except in the case of breakage or significant
deterioration causing the tool to malfunction
Single use
250 uses
250 uses
250 uses
Drilling guides
250 uses
One use is equivalent to one reprocessing cycle.
Torque transmission The instruments can be reused in accordance with the maximum number of uses defined in the table below, except in cases where there are signs of deterioration (illegibility of markings or markers, deterioration of the coating, signs of corrosion, etc.).
Range Integral
Type of device
Product lifespan
Implant screwing wrenches 50 uses
Implant screwing mandrels 50 uses
Implant screwing wrenches 250 uses
Implant holder
250 uses
Implant screwing mandrels 250 uses
Axiom® Multi
Universal instrument mandrels
Level®
Prosthetic screwing
wrenches
Prosthetic screwing
mandrels
Mandrel extension
100 uses 250 uses 250 uses 250 uses
One use is equivalent to one reprocessing cycle.
Gripper components The instruments can be reused in accordance with the maximum number of uses defined in the table below, except in cases where there are signs of deterioration (illegibility of markings or markers, deterioration of the coating, signs of corrosion, etc.).
Range
Type of device Product lifespan
Axiom® Multi Level® AA screw gripper Single use
One use is equivalent to one reprocessing cycle.
1.15 Further information
For more information on the use of Anthogyr products, please contact your
local Anthogyr sales representative or contact Anthogyr customer service or
visit ifu.anthogyr.com and www.anthogyr.com. For more specific information on
Anthogyr instruments, please refer to:
First Drill guided surgery:
Anthogyr FIRST DRILL Guided Surgery user guide
(AXIOM-GID_NOT) INTEGRAL guided surgery:
Anthogyr INTEGRAL Guided Surgery user guide
(AXIOM-INT_NOT) Axiom® Multi Level®:
Axiom® Multi Level® surgical user guide (AXIOM-
MLC_NOT)
Axiom® Multi Level® Prosthetic user guide (AXIOM-
MLPNOT)
Others:
Cleaning and sterilisation user guide (NETT-STE
NOT)
1.16 Storage
Store these products in a clean, dry area, at room temperature. Improper
storage may compromise the essential characteristics of the materials and
design, which may lead to device failure.
1.17 Waste treatment
Waste resulting from the intervention (packaging, part extracted, etc.) must
be handled as medical waste under the responsibility of the user.
1.18 Patient information
Patients must accept regular medical follow-ups and should consult their
doctor in the event of any unexpected change in the performance of the
prosthetic reconstitution. Patients must be informed of the need to ensure
regular oral hygiene. Patient must be advised to remain cautious for the first
few weeks after surgery.
1.19 Notes
The practitioner must have the necessary knowledge to practice dental
implantology and must be familiar with the handling instructions for Anthogyr
products as described in this document in order to use Anthogyr products
safely and in accordance with their instructions for use. Anthogyr products
must be used in accordance with the manufacturer’s instructions for use. The
dental
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us Instructions for Use Anthogyr instruments Valid only in the United States
surgeon is solely responsible for the proper use of Anthogyr products in accordance with their instructions for use and to determine whether the product is suitable for the individual patient’s situation. Anthogyr products are part of a complete range and must be used in combination with the corresponding original components and instruments distributed by Anthogyr, its parent company and any affiliates or subsidiaries of the parent company (“Straumann”). The use of third-party products not distributed by Anthogyr voids any warranty or other obligation, express or implied, of Anthogyr. Any product-related issues must be reported to the local Anthogyr organisation together with the product in question. In the event of a serious incident, the user must file a report with the local Anthogyr organisation and the appropriate competent authority in accordance with local regulations. Anthogyr also offers an online complaint service in the countries concerned.
1.20 Validity
The publication of this document supersedes and replaces all previous
versions. Anthogyr all rights reserved. Anthogyr® and/or other trademarks and
logos of Anthogyr® mentioned herein are trademarks or registered trademarks of
Anthogyr.
1.21 Availability
Some components of the Anthogyr implant system are unavailable in certain
countries.
1.22 Symbols
The following table describes the symbols that may be printed on the packaging
label. Please refer to the label on the packaging for the applicable product
symbols.
Symbol Description of symbol Source of symbol
Manufacturer
ISO 15223-1
Symbol
Description of symbol Source of symbol
Sterilised using irradiation
ISO 15223-1
Do not resterilise
ISO 15223-1
Non-sterile
ISO 15223-1
Sterilisable in a steam steriliser (autoclave) at temperature specified
Non sterilisable in a steam steriliser
(autoclave) at temperature specified
Do not use if packaging is damaged and consult instructions for use
ISO 7000-2868 Anthogyr ISO 15223-1
Keep away from sunlight ISO 15223-1
Do not re-use
ISO 15223-1
Caution
ISO 15223-1
Contains hazardous substances
ISO 15223-1
Screwing torque
Anthogyr
Axiom® BL countersink +
pin
Anthogyr
Date of manufacture ISO 15223-1
Catalogue number
ISO 15223-1
Batch code
ISO 15223-1
SN
Serial number
ISO 15223-1
Consult instructions for
use or consult electronic ISO 15223-1 instructions for use
Medical Device
ISO 15223-1
CE marking- compliance Directive 93/42/CEE
with current regulations
———— MDR (EU) 2017/745
U.S.federal law restrics
this device to sale by or on the order of a dental
21 CFR 801.109(b)(1)
professional.
Use-by date
ISO 15223-1
Single sterile barrier system
Single sterile barrier system with protective packaging inside
ISO 15223-1 ISO 15223-1
6/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
2. Instructions for use for Anthogyr Surgical and prosthetic cassettes
Caution: U.S. federal law restricts this device to sale by or on the order of a dental professional.
2.1 Product description
Anthogyr instruments are part of the Anthogyr Axiom® systems and are divided
into types according to use:
Kits:
Anthogyr Cassettes: guided surgical kits, Axiom®
Multi Level® surgical kits, Axiom® Multi Level® prosthesis kits, and empty
kits (list in Table 1)
INTEGRAL Guided Surgery Cassettes: INTEGRAL
surgical kit and empty kits (list in Table 1) Anthogyr cassettes are reusable
rigid containers, comprising a case bottom (base), one or more removable inner
tray base (tray) and a tray lid (lid). The trays are composed of grommets made
of medical grade silicone, namely grommets used to maintain the Anthogyr
dental instruments in place during the surgical or prosthetic procedure and
during sterilization. The base and trays have markings and/or colors code to
indicate either the surgical workflow, or the position of the instruments in
the kit. The lid holds all the instruments securely in place during treatment.
For a detailed product description, item reference number and dimensions,
please consult the product label and the Anthogyr product catalogue. For
detailed information on the instruments, their specific indications for use,
their use in specific procedures and their compatibility, please refer to the
user manuals and brochures listed in the “Further Information” section. The
notion of “cassette” as the same meaning of the notion of “kit”.
Materials: Stainless steel, medical grade silicone and PolyPhenylSulphone
(PPSU).
2.2 Intended use
Anthogyr cassettes are intended to organize instruments, and secure
instruments during the sterilization phase.
2.3 Indications for use
The Anthogyr Surgical Cassettes are designed to hold
various dental surgical drills and tools in order to organize, steam
sterilize, and protect the instruments that are sterilized by healthcare
provider. The cassette is to be enclosed in an FDA cleared steam sterilizable
pouch. The cassettes are not intended on their own
to maintain sterility. The cycle of sterilization is INMODOPS3, INMODOPS3L,
INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-
vacuum steam: 132°C (270°F) during 4 minutes with 20 minutes drying time The
Anthogyr Surgical Cassettes have been validated for a maximum load of (with
the associated instru-
ments).
The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical and Prosthetic
Cassettes:
INMODOPS3, INMODOPS3V, INMODOPS3L,
INMODOPS3LV, INMODOPP3, INMODOPP3V:
130x155x47 mm
INMODIGM, INMODIGMV: 76x155x47 mm
The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes,
uses pre-vacuum steam: 132°C (270°F) during 4 minutes with 30 minutes drying
time. Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a
maximum load of with the
associated instrument. The worst-case recommended
load is: 886 g. The device dimension of Anthogyr INTEGRAL Guided Surgery
Cassettes is 290x176x62 mm. The cassettes are not intended to be stacked
during sterilization process.
2.4 Contraindication
Allergy or hypersensitivity to chemical components in the materials used and
mentioned in the “Product description” section.
2.5 Warning Products must be protected against inhalation or
swallowing when handled in the mouth. Aspiration of products can lead to
infection or incidental physical injury.
Do not use damaged, corroded, or dull instru-
ments. Always inspect instruments before use.
Do not exceed the maximum number of uses for
the device as detailed in the “Lifespan of products”
section.
Avoid the area of the mandibular nerve canal du-
ring the implant bed preparation and the insertion of the implant. Nerve
damage can lead to anesthesia, paranesthesia, and dysesthesia.
Do not exceed the recommended insertion torques
as this may cause bone necrosis and fracture. Specific warning: The First
Drill guided surgery protocol is not applicable to the preparation of implant
sites for Axiom® implants with a diameter greater than 4.6 mm and a
length greater than 14 mm. The INTEGRAL guided surgery protocol is not
applicable to the preparation of implant sites for Axiom® 2.8 and Axiom®
implants with a diameter greater than 4.6mm and a length greater than 14mm.
Follow the loading chart instructions for guidance on loading the cassettes.
Do not exceed the maximum loading. Anthogyr cassettes have been validated for
the following maximum loads (including instruments and cassette):
Grouping name
Material
Description
Max. weight
load incl. Cassette (g)
INMODOPS3 AXIOM MULTI 407
LEVEL SURGERY KIT
INMODOPS3V Empty Axiom ML 407 Surgery Kit
INMODOPS3L AXIOM ML
412
SURGERY KIT +
LARGE Ø
INMODOPS3LV EMPTY AXIOM 412
Anthogyr
ML SURG KIT +
Surgical and
ØL
Prosthetic INMODIGM Cassette
GUIDED
259
SURGERY INITIAL
M KIT
INMODIGMV EMPTY ID
259
GUIDED SURGERY KIT
INMODOPP3 AXIOM MULTI 408
LEVEL PROSTH KIT
INMODOPP3V EMPTY AXIOM 408 ML PROSTH KIT
MODGS3642 INTEGRAL SURG 886 KIT Ø3.6-4.2
MODGS36
INTEGRAL SURG 802 KIT Ø3.6
MODGS42
INTEGRAL SURG 825 KIT Ø4.2
MODGS50 INTEGRAL SURG 866
INTEGRAL
KIT Ø5.0
Guided
Surgery Cassette
MODGS3642V INTEGRAL SURG 886 KT Ø3.6-4.2 EMPT
MODGS36V INTEGRAL SURG 802 KIT Ø3.6 EMPTY
MODGS42V INTEGRAL SURG 825 KIT Ø4.2 EMPTY
MODGS50V INTEGRAL SURG 866 KIT Ø5.0 EMPTY
Table 1: Cassettes references with
grouping name
2.6 Caution / Precaution
It is essential to handle the Anthogyr cassettes according to the basic
information documentation for the applicable surgical and prosthetic
procedure. Ensure
sterile handling. Never use potentially contaminated components. Only use
adequately processed devices if indicated for multiple uses. The Anthogyr
Surgical and Prosthetic Cassette have been validated to withstand 250
processing cycles provided that the recommended conditions of use are
followed. The INTEGRAL Guided Surgery Cassette have been validated to
withstand 100 processing cycles provided that the recommended conditions of
use are followed.
2.7 Residuals risks and side effects
The clinical outcome of dental treatment is influenced by multiple factors.
The following residual risks and possible side effects are related to the use
of the instruments and may lead to additional dental treatment at the dental
practice:
7/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
Residual risks:
additional treatment at dentist’s office bite/mastication/phonetic problems
bleeding bone compression bone damage damage to adjacent/opposing tooth
discomfort hyperplasia hypersensitivity/allergic reaction injuries of gingiva
irritation/inflammation local or systemic infection (including peri-implan-
titis, periodontitis, gingivitis, fistula)
local pain longer recovery/healing time than expected loss of implant loss of
prosthetic component nerve damage possibly resulting in chronic pain
paraesthesia, dysaesthesia poor aesthetic outcome possibility of prolongation
of surgery possibility of surgical implant explantation possibility to
swallow/inhale small parts during
the procedure
recall to the dentist’s office sinus perforation swelling
Side effects:
swelling local inflammation bruising resorption of maxillary/mandibular ridge
bone local infection minor bleeding
2.8 Compatibility information
Anthogyr cassettes are suitable to enclose Anthogyr instruments according to
marking and color coding provided on the tray of the reusable containers. Make
sure only to use original Anthogyr instruments with the cassettes. Storage and
organization of non-Anthogyr instruments and components can lead to mechanical
and/or instrument failure.
2.9 Cleaning and disinfection
Point-of-Use Processing: Never let surgical residues (blood, secretion, tissue
residues) dry on an instrument; clean immediately after surgery. The
instruments that go in the cassette are sold included in the cassette or
separately. A flow chart to summarize the cleaning process is available in
appendix 1. Anthogyr instruments and cassettes are delivered non-sterile.
Clean this product according to the following instructions after each use:
Remove the instruments from the tray and clean
separately. The instruments must be used according to their own Instructions
for Use (available in ifu.anthogyr.com).
Totally disassemble the tray before cleaning: disas-
semble the parts of the cassettes as in appendix 2 and in appendix 3.
2.9.1 Manual cleaning A. Cassettes
a. Cleaning 1. Thoroughly clean the devices with the following
steps. 2. Brush meticulously all surfaces under tap water
at room temperature for at least 1 minute using an adapted soft brush (nylon)
to hard reach areas. 3. Completely submerge in a detergent and disinfectant
solution for at least 3 minutes following the manufacturer’s instructions
temperature, and concentration (paragraph below). 4. Whilst immersed, brush
meticulously all surfaces with a soft brush (example: nylon) for at least 1
minute using an adapted nylon brush to hard-
reach areas. 5. During immersion, move the devices by making
3 back and forth movements.
b. Rinsing and drying 6. Rinse with critical water (per AAMI TIR34) for at
least 1 minute. 7. During rinsing, brush meticulously all surfaces
with a soft brush (example: nylon) for at least 30 seconds using an adapted
nylon brush to hard-
reach areas. 8. Dry immediately, carefully, with a soft lint-free
cloth. 9. A visual inspection, an inspection end point on the
cassette or the instruments. If the user sees visual contamination on the
cassette. The practitioner must restart the cleaning process. B. Instruments
in Anthogyr Surgical and Prosthetic Cassettes
a. Cleaning 1. Thoroughly clean the devices with the following
steps. 2. Brush meticulously all surfaces with a soft brush
(example: nylon) under tap water at room temperature for at least 1 minute.
Use an adapted soft-nylon brush to each lumen or hole at least one time. 3.
Completely submerge in a detergent and disinfectant solution for at least 5
minutes following the manufacturer’s instructions temperature, and
concentration (paragraph below). Flush each lumen or hole with detergent
solution at least one time. 4. Whilst immersed, brush meticulously all
surfaces with a soft brush (example: nylon) for at least 1 minute or until
there is no visible trace of con-
taminants. Use an adapted soft nylon brush to each lumen or hole for 20
seconds. 5. During immersion, move the devices by making 3 back and forth
movements.
b. Rinsing and drying 6. Rinse with critical water (per AAMI TIR34) for at
least 1 minute. 7. During rinsing, brush meticulously all surfaces
with a soft brush (example: nylon) for at least 30 seconds using an adapted
nylon brush to hard-
reach areas.
Flush each lumen or hole with tap water at least one time. 8. Rinse with
critical water (per AAMI TIR34) at room temperature for at least 1 minute. 9.
A visual inspection, an inspection end point on the instrument. If the user
sees visual contamination on the cassette, he must restart the cleaning
process.
C. Products and detergents Anthogyr used the following products and detergents
to approve the various protocols. However, other products and detergents may
be used according to local availability. Approval of these products is the
responsibility of the user. Cidezyme (ASP) at a concentration of 8mL/L. For
sterilization, see the “Sterilization” section.
2.9.2 Automated cleaning A. Cassettes
a. Manual pre-cleaning 1. Thoroughly clean the devices with the following
steps. 2. Soak the device in a detergent and disinfectant
solution for at least 5 minutes following the manufacturer’s instructions,
temperature, and concentration (paragraph below). 3. Whilst immersed, brush
all surfaces of the devices for at least 30 seconds using a soft brush
(example: nylon). b. Automatic cleaning
i. Anthogyr Surgical and Prosthetics Cassettes 1. Thoroughly clean the devices
with the following
steps. 2. Pre-wash with cold tap water (<45°C) for 2 min. 3. Wash at heated
water (50-60°C) C for 5 min with
an enzymatic detergent (paragraph below). 4. Neutralization at cold water
(<45°C) for 1 min
with an appropriate neutralizer (paragraph below) 5. Intermediate rinsing at
cold water (<45°C) for
1 min. 6. Thermal rinsing at 90°C for 5 minutes with critical
water (per AAMI TIR34). 7. Drying at 60°C for 10 min. 8. A visual inspection,
an inspection end point on the
cassette. If the user sees visual contamination on the cassette. he must
restart the cleaning process.
ii. INTEGRAL Guided Surgery Cassette 1. Thoroughly clean the devices with the
following
steps. 2. Pre-wash with cold tap water (<45°C) for 4 min. 3. Wash at heated
water (50-60°C) C for 5 min with
an enzymatic detergent (paragraph below). 4. Neutralization at heated water
(50-60°C) for
3 min with an appropriate neutralizer (paragraph below). 5. Intermediate
rinsing at cold water (40°C) for
2 min. 6. Thermal rinsing at 95°C for 10 minutes with cri-
tical water (per AAMI TIR34). 7. Final rinsing at cold water (40°C) for 2 min
with
critical water (per AAMI TIR34). 8. Drying at 140°C for 10 min.
8/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
9. A visual inspection, an inspection end point on the cassette. If the user
sees visual contamination on the cassette. he must restart the cleaning
process.
B. Instruments in Anthogyr Surgical and Prosthetic Cassettes
a. Manual pre-cleaning
1. Thoroughly clean the devices with the following steps.
2. Soak the device in a detergent and disinfectant solution for at least 5
minutes following the manufacturer’s instructions, temperature, and
concentration (paragraph below).
3. Whilst immersed, brush all surfaces of the test article for at least 30
seconds using a soft nylon bristle. For each lumen or hole, use an adapted
soft nylon brush during 30 secondes. b. Automatic cleaning
4. Pre-wash with cold tap water (<45°C) for 2 min. 5. Wash at heated water
(50-60°C) C for 5 min with
an enzymatic detergent (paragraph below). 6. Neutralization at heated water
(50-60°C) for
1 min with an appropriate neutralizer (paragraph below). 7. Intermediate
rinsing at cold water (<45°C) for
1 min.
8. Thermal rinsing at 90°C for 5 min with critical water (per AAMI TIR34).
9. Drying at 60°C for 10 min. 10. A visual inspection, an inspection end
point on
the instrument. If the user sees visual contamination on the cassette. he must
restart the cleaning process. C. Instruments in INTEGRAL Guided Surgery
Cassettes a. Automatic cleaning 1. Pre-wash with cold tap water (<45°C) for 2
min. 2. Wash at heated water (50-60°C) C for 5 min with an enzymatic detergent
(paragraph below). 3. Neutralization at heated water (50-60°C) for 1 min with
an appropriate neutralizer (paragraph below). 4. Intermediate rinsing at cold
water (<45°C) for
1 min.
5. Thermal rinsing at 90°C for 5 min with critical water (per AAMI TIR34).
6. Drying at 60°C for 10 min. 7. A visual inspection, an inspection end point
on
the instrument. If the user sees visual contamination on the cassette. he must
restart the cleaning process. D. PRODUCTS AND DETERGENTS
Manual pre-cleaning
Cidezyme (ASP) at a concentration of 8mL/L. Automatic cleaning Enzymatic
detergent: Neodisher Mediclean Dental
(DrWeigert) at a concentration of 2mL/L. Neutraliser: Neodisher Z Dental
(DrWeigert) at a
concentration of 1mL/L. For sterilization, see the “Sterilization” section.
2.9.3 Function test
Process contaminated instruments and remove da-
maged instruments. Damaged instruments must be cleaned and disposed of
separately. After cleaning, check all cassette parts and instruments for
corrosion, visible dirt, damaged surfaces, blunt cutting edges, chipping and
contamination. Critical areas such as handle structures, joints or holes must
be inspected carefully. Instruments with illegible markings/labelling must be
replaced. Before every use, the device must be carefully checked for proper
functioning and damage. After functional testing, assemble the device for
sterilization (as in Appendix 2 and in Appendix 3). For USA – Configuration:
Wrapped in two layers of Halyard Health (H200-510(k) K082554) polypropylene
wrap using simultaneous envelope folding techniques.
2.10 Sterilization
Anthogyr cassettes are delivered non-sterile. Anthogyr recommends the
following procedure for sterilization prior to use. A flow chart to summarize
the sterilization process is available in appendix 1. ATTENTION: This product
cannot be autoclaved in its original packaging.
Grouping name Method
Conditions
Drying Time
For the United States:
Anthogyr
Surgical and Prosthetic Cassette
Moist Heat (Autoclave) Pre-vacuum
132°C (270°F) for 4 min
20 min2
INTEGRAL
Guided Surgery Cassette
Moist Heat (Autoclave) Pre-vacuum
132°C (270°F) for 4 min
30 min2
2 Nevertheless, a drying time shorter than defined time cannot be applied.
Precautions: The sterilizer must offer a pre-vacuum method with sufficient
device
drying time and be compliant with EN 13060 or
EN 285
be validated according to EN ISO 17665 (valid
IQ/OQ and product-specific performance assess-
ment (PQ)).
Always observe the operating instructions of the manufacturer of the
sterilizer, especially with regard to loading weight, operating time and
functional testing. When loading the sterilizer, place the cassette on the
sterilizer rack in such a way that under no circumstances does it come into
contact with the walls of the sterilizer. Do not put the cassette on its side
or upside down with the lid facing down. Do not place corroded or rusty
instruments in the cassette for sterilization. These contaminate the water
circulation system of the sterilizer with rust particles. During every
subsequent sterilization cycle, these rust particles cause rust on
instruments that were originally intact.
If visible signs of moisture are present (damp spots on sterile packaging,
pooled water in the load) at the
end of the sterilization cycle, repackage and resterilize using a longer
drying time. After sterilization, pack the instruments at a dry and dust-free
place. Sterilized devices should be used immediately after sterilization. In
case of storage, strictly follow the manufacturer’s instructions of the
sterilization acces-
sories and storage containers. *For United States only:
Users in the United States should ensure that the sterilizer and all
sterilization accessories (sterilization wraps, pouches, sterilization trays,
biological indicators and chemical indicators) are cleared by FDA for the
intended sterilization cycle.
2.11 Protocol for use
Refer to the brochures listed in the “Further information” section for
detailed step-by-step instructions.
2.12 Lifespan of products
The instruments can be reused in accordance with the maximum number of uses
defined in the table below, except in cases where there are signs of
deterioration (illegibility of markings or markers, deterioration of the
coating, signs of corrosion, etc.)
Type of device as in table 1
Product lifespan
Anthogyr Surgical and Prosthetic Cassettes
250 uses
Anthogyr INTEGRAL Guided 100 uses Surgery Cassettes
2.13 Further information
For more information on the use of Anthogyr products, please contact your
local Anthogyr sales representative or contact Anthogyr customer service or
visit ifu.anthogyr.com and www.anthogyr.com.
2.14 Storage
Store these products in a clean, dry area, at room temperature. Improper
storage may compromise the essential characteristics of the materials and
design, which may lead to device failure.
2.15 Disposal
Disposal should be handled in an environmentally sustainable manner according
to local regulations. Hazardous waste from contaminated devices or sharps
should be disposed of in appropriate containers which meet specific technical
requirements.
2.16 Information to be provided to the patient
Information on contraindications, warnings, precautions, side effects and
complications with Anthogyr devices should be provided to the patient.
2.17 Notes
The practitioner must have the necessary knowledge to practice dental
implantology and must be familiar with the handling instructions for Anthogyr
products as described in this document in order to use Anthogyr products
safely and in accordance with their instructions for use.
9/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
Anthogyr products must be used in accordance with the manufacturer’s instructions for use. The dental surgeon is solely responsible for the proper use of Anthogyr products in accordance with their instructions for use and to determine whether the product is suitable for the individual patient’s situation. Anthogyr products are part of a complete range and must be used in combination with the corresponding original components and instruments distributed by Anthogyr, its parent company and any affiliates or subsidiaries of the parent company (“Straumann”). The use of third-party products not distributed by Anthogyr voids any warranty or other obligation, express or implied, of Anthogyr. Any product-related issues must be reported to the local Anthogyr organization together with the product in question. In the event of a serious incident, the user must file a report with the local Anthogyr organization and the appropriate competent authority in accordance with local regulations. Anthogyr also offers an online complaint service in the countries concerned.
2.18 Validity
The publication of this document supersedes and replaces all previous
versions. Anthogyr all rights reserved. Anthogyr® and/or other trademarks and
logos of Anthogyr® mentioned herein are trademarks or registered trademarks of
Anthogyr.
2.19 Availability
Some components of the Anthogyr implant system are unavailable in certain
countries.
2.20 Symbols
The following table describes the symbols that may be printed on the packaging
label. Please refer to the label on the packaging for the applicable product
symbols.
Symbol Description of symbol Source of symbol
Manufacturer
ISO 15223-1
Date of manufacture ISO 15223-1
Catalogue number
ISO 15223-1
Batch code
ISO 15223-1
SN
Serial number
ISO 15223-1
Consult instructions for
use or consult electronic ISO 15223-1 instructions for use
Medical Device
ISO 15223-1
CE marking- compliance Directive 93/42/CEE
with current regulations
———— MDR (EU) 2017/745
U.S. federal law restricts
this device to sale by or on the order of a dental
21 CFR 801.109(b)(1)
professional.
Use-by date
ISO 15223-1
Single sterile barrier system
ISO 15223-1
Symbol
Description of symbol
Single sterile barrier system with protective packaging inside
Source of symbol ISO 15223-1
Sterilised using irradiation
ISO 15223-1
Do not resterilise
ISO 15223-1
Non-sterile
ISO 15223-1
Sterilisable in a steam steriliser (autoclave) at temperature specified
Non sterilisable in a steam steriliser
(autoclave) at temperature specified
Do not use if packaging is damaged and consult instructions for use
ISO 7000-2868 Anthogyr ISO 15223-1
Keep away from sunlight ISO 15223-1
Do not re-use
ISO 15223-1
Caution
ISO 15223-1
Contains hazardous substances
ISO 15223-1
Screwing torque
Anthogyr
Axiom® BL countersink +
pin
Anthogyr
10/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the
United States
Appendix 1 Flow chart of cleaning and sterilization process
Use
Transport
Preparation and disassembling the instruments from the kit
Cleaning of the instruments (see §9)
Cleaning of the kits (see §9)
Not compliant
Automatic cleaning of the instruments (see §9)
Manual cleaning of the instruments (see §9)
Automatic cleaning of the kits (see §9)
Manual cleaning of the kits (see §9)
Visual inspection, an inspection end point
(see §9) ? Compliant Device assembly
Kit assembly and packing with the instruments
Sterilisation (see §10)
Storage
11/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the
United States
Appendix 2 Disassembly of the Anthogyr Cassettes
Æ Open the covers.
Æ Unclip the insert pegs located on the back of the kit.
Insert 3/4
Insert 1/4
Æ Remove the ¼ and ¾ inserts from the main kit body.
Æ Carefully remove the side arms from the main body. Æ Detach the transparent
cover pivot pegs. Æ Remove the covers.
Æ Remove the side covers from the main body. Æ Detach the side covers from the
side of the kit. Æ Remove the side cover ends around the stainless steel
plates. Æ Detach the silicone cover plates.
For the storage of the instruments in the cassette in sales configuration, see
appendix 4.
Repeat each stage in reverse order to assemble
8
12/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the
United States
Appendix 3 Disassembly of INTEGRAL guided Surgery Cassettes
1. Remove the lid. 2. Remove the instruments. For the storage of the
instruments in the cassette in sales configuration, see appendix 4. 3. Remove
the white tray Repeat each stage in reverse order to assemble.
13/17
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
Appendix 4 Storage of the instruments in the cassette in sales configuration
INMODOPS3:
REVERSIBLE MANUAL RATCHET WRENCH Ref. INCC
MANUAL SURGICAL WRENCH
Ref. OPCS100
SURGICAL KIT
Axiom® TL AND inLink® SCREW WRENCHES AND MANDRELS
Ref. TIM100S
Ref. TIW100S
TAPS
Ref. OPTA34L Ref. OPTA40L Ref. OPTA46L Ref. OPTA52L
ADDITIONAL SURGICAL ACCESSORIES
4 ADJUSTING GROMMETS to convert spare places of manual wrenches into mandrels’
spaces.
STEPWISE S-DRILLS
Ref. OPFE30S Ref. OPFE36S Ref. OPFE42S Ref. OPFE48S
MANDREL EXTENSION POINTED DRILL
Ref. INEXM Ref. OPPO15150
INITIAL S-DRILL Ø2.0 mm Ref. OPFI20S
STEPWISE SDRILL
GAUGES
Ref. OPJD020 Ref. OPJD020 Ref. OPJD020 Ref. OPJD024 Ref. OPJD030 Ref. OPJD036
Axiom® TL AND inLink® SCREW WRENCHES AND MANDRELS
Ref. TIM100L Ref. TIW100L
Axiom® BL SCREW WRENCHES AND MANDRELS Ref. OPMV180 Ref. OPCV060 Ref. OPMV250 Ref. OPCV160
Ref. OPFE24S
INITIAL L-DRILL Ø2.0 mm / STEPWISE -L.
Ref. OPFE20L Ref. OPFE24L Ref. OPFE30L Ref. OPFE36L Ref. OPFE42L Ref. OPFE48L
INMODOPS3L:
REVERSIBLE MANUAL RATCHET WRENCH Ref. INCC
AXIOM® TL AND INLINK® SCREW WRENCHES AND MANDRELS
Ref. TIM100S Ref. TIW100S Ref. TIM100L Ref. TIW100L
TAPS
Ref. OPTA34L Ref. OPTA40L Ref. OPTA46L Ref. OPTA52L
ADDITIONAL SURGICAL ACCESSORIES 2 ADJUSTING GROMMETS to convert spare places of manual wrenches into mandrels’ spaces.
STEPWISE S – DRILLS
Ref. OPFE30S Ref. OPFE36S Ref. OPFE42S Ref. OPFE48S Ref. OPFE54S Ref. OPFE60S
MANDREL EXTENSION
Ref. INEXM
POINTED DRILL
Ref. OPPO15150
L SURGICAL KIT
INITIAL S – DRILL Ø2.0 mm
STEPWISE S – DRILL
Ref. OPFI20S We recommend that all cutting instruments should be used max. 20 times
Ref. OPFE24S
GAUGES
Ref. OPJD020 Ref. OPJD020 Ref. OPJD020 Ref. OPJD024 Ref. OPJD030 Ref. OPJD036
MANUAL SURGICAL WRENCH Ref. OPCS100
AXIOM® BL SCREW WRENCHES AND MANDRELS Ref. OPMV180 Ref.. OPCV060 Ref. OPMV250 Ref. OPCV160
INITIAL L – DRILL Ø2.0 mm / STEPWISE – L DRILLS Ref. OPFI20L Ref. OPFE24L Ref. OPFE30L Ref. OPFE36L Ref. OPFE42L Ref. OPFE48L 339425_A
14/17
PRACTI
WARNING! Before each surgery, including the first, all tools and tool supports must be pre-disinfected, cleaned, decontaminated and sterilised according to a specific protocol (please see p. 20 in the cleanuinsgaInnsdtrsutcetriiolinssatfioornUsseectioAnnt)h. ogyr surgical cassettes Valid only in the United States INMODIGM:
Pin drill Initial guided drills: – short – long – extra-long Guided pointer drills without stop: – short – extra-long
Fixation pin
-
- Guided pointer drill with stop
INMODOPP*3F:ree slots, suitable for optional ancillaries offered by Anthogyr
if available, or other ancillaries, at the practitioner’s discretion.
TECHNICAL SPECIFICATIONS
The kit is designed with medical-grade materials to tolerate thermal
disinfection and sterilisation via autoclave. Adjustable protective caps make
the surgical kit modular PtoRoOpStTimHEisTeICtoKoIlTaccess.
HEXA INSTRUMENTS
Ref. INMHECV Ref. INMHELV Ref. INCHECV
Ref. INCHELV
ADDITIONAL PROSTHETIC ACCESSORIES 4 SPARE SPACES – L 2 SPARE SPACES – S 1
SPARE SPACE – XL (for specific tools)
DYNAMOMETRICAL RATCHET WRENCH Ref. INCCD
MULTI UNIT INSTRUMENTS
Ref. MUW100 Ref. MUM100S
inLink® ABUTMENT INSTRUMENTS
Ref. TIM100S Ref. TIM100L
Ref. TIW100S
9
Ref. TIW100L
BALL INSTRUMENTS
Ref. INBM100S Ref. INBM100L Ref. INBW100S
Ref. INBW100L
GRIPPER/DISCONNECTOR FOR ABUTMENT Ref. INEXPS
063KITOPP3_NOT – 2020-02
15/17
Cassette for Ø 3.6 mm GUIDE SLEEVES
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
Cassette for Ø 4.2 mm GUIDE SLEEVES
16/17
Cassette for Ø 5.0 mm GUIDE SLEEVES
us Instructions for Use Anthogyr surgical cassettes Valid only in the United States
Cassette for Ø 3.6 mm and 4.2 mm GUIDE SLEEVES
17/17