1/6 en -Instructions for use - Anthogyr instruments Anthogyr instruments are part of the Anthogyr Axiom , Anthofit and Mini 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,
Anthogyr, Instructions For Use
en - Instructions for use - Anthogyr instruments
K A Anthogyr SAS
2237 Av. André Lasquin 74700 Sallanches France Phone : +33(0)4 50 58 02 37
www.anthogyr.com Email : contact@anthogyr.com
Validity Date : 2021-11 REF : 063INSTRU_NOT Index : B
Instructions for use for standard or guided surgery instruments used with the Axiom® BL, Axiom® TL, Axiom® 2.8, Anthofit®, and Mini implant ranges.
1. Product description Figure 1
1. Anthofit® Initial drill 2. Mini implant initial drill 3. Axiom® initial drill 4. Anthofit® graduated depth gauge 5. Mini implant gauge Ø1.5 / Ø2.0
Anthogyr instruments are part of the Anthogyr Axiom®, Anthofit® and Mini 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. - Kits: guided surgical kits, Axiom® Multi Level® surgical kits, Axiom® 2.8 surgical kit, Mini implant surgical kit, Anthofit® surgical kit, Axiom® Multi Level® prosthesis kits, Anthofit® prosthesis kit, stop kits, empty kits.
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.
6. Axiom® gauge 7. Anthofit® twist drill 8. Axiom® step drill 9. Cortical drill 10. Anthofit® countersink
Specific product description:
Kits: Anthogyr kits are reusable containers consisting of two main components: a base with a cover and one or more inserts. The inserts are composed of other components made of silicone rubber, namely silicone strips and holders used to maintain the Anthogyr instruments in place during the surgical or prosthetic procedure and during sterilisation. The base and inserts have markings and/or colours code to indicate either the surgical workflow, or the position of the instruments in the kit. The cover holds all the instruments securely in place during treatment. Stop kits are reusable containers consisting of a drilled base to accommodate the stops and a cover to hold the stops in place during the treatment phases.
Materials:
Instruments are made of Titanium (Ti6Al4V ELI),
Stainless steel, Polyetheretherketone (PEEK),
Silicone,
Polypropylene
(PP),
PolyPhenylSulphone (PPSU) or PVC.
11. Axiom® TL countersink 12. Anthofit® tap 13. Axiom® REG tap 14. Axiom® PX tap
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.
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. Kits Anthogyr kits are intended to organise instruments, and secure instruments during the sterilisation phase.
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3. Indications 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 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. Hard bone cutting instruments are indicated for use in Class I bone. 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.
Kits Anthogyr kits are used to store and secure instruments and auxiliaries between and during surgical and/or prosthetic manipulations, transportation and sterilisation. They are indicated for use in health facilities by health professionals. These kits are indicated for use with a validated, legally marketed, double sterilisation bag to maintain the sterility of sealed devices.
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.
5. Contraindications Allergy or hypersensitivity to chemical components in materials used and mentioned in the "Product description" section.
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.
Do not exceed the following cutting speeds:
Surgical stage
Cutting instrument
Speed (rpm)
Preparation of
the gum, guided Gingival cutter
50
and non-guided
Preparation of the alveolar crest, nonguided
Pointer drill Round bur Lindemann bur
1500 1500 1500
Preparation of the alveolar crest, guided
Cortical bur Bone mill Integral pointer drill Initial pointer drill
500 500 1000 1500
Axiom® initial drills
1500
Initial initial drills
1500
Integral initial drills
1000
Anthofit® initial drills
1250
Drill, guided and AGS step drills
non guided
Axiom® step drills
1000 1000
Axiom® 2.8 step drills
1200
Anthofit® twist drills
1000
Mini implant twist drills 1500
Axiom® cortical drills
1000
Preparation of Axiom® BL countersink
50
the bone crest post-drilling, non
Anthofit® countersink
500
-guided
Axiom® TL countersink
50
Tapping, guided Anthofit® tap
50
and non-guided Axiom® tap
25
Drill for pin: - Please note that 0.5 mm of apical overdrilling 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.
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The Initial guided surgery protocol is not applicable to the preparation of implant sites for Anthofit®, Mini implant and 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 Anthofit®, Axiom® 2.8, Mini implant and Axiom® implants with a diameter greater than 4.6mm and a length greater than 14mm.
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)
Axiom® REG implant
25
Axiom® PX implant
15
Tightening of the Axiom® X3 implant
15
implant, guided
and non-guided Anthofit® implant
50
Axiom®2.8 implant
25
Mini implant
15
Axiom® implant screwing instruments: - The Axiom® BL and Axiom® TL 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 and Axiom® TL 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 instruments.
7. Caution/precautions 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.
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 : possibility to swallow / inhale small parts during the procedure, hypersensitivity / allergic reaction, bite / mastication / phonetic problems, bleeding, bone compression, bone damage, injuries of gingiva, damage to adjacent/ opposing tooth, longer recovery / healing time than expected, recall to the dentist's office, discomfort, possibility of surgical implant explantation, possibility of prolongation of surgery, additional treatment at dentist's office, hyperplasia, implant fracture, loss of implant, local infection (including peri-implantitis, periodontitis, gingivitis, fistula) or systemic, irritation / inflammation, local pain, loss of prosthetic component, nerve damage possibly resulting in chronic pain, paraesthesia, dysesthesia, poor aesthetic outcome, sinus perforation, swelling, bruising, resorption of maxillary/mandibular ridge bone.
9. Compatibility information Anthogyr instruments are available in a variety of configurations. Please note that only Anthogyr instruments can be used with other parts of the Anthogyr implant systems with the corresponding connection and size.
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
Drilling diameter
Bur / tap diameter
Green
Axiom®
Ø2.4
/
Orange
Axiom®
Ø2.6
Ø2.8
Axiom®
Ø3.0
Ø3.4
Red
Anthofit®
Ø3.0
Ø3.5
Black
Anthofit® Mini implant
Ø3.25 Ø1.5
Ø3.75 /
Axiom®
Ø3.6
Ø4.0
Yellow
Anthofit®
Ø3.5
Ø4.0
Axiom®
Ø4.2
Ø4.6
White
Anthofit®
Ø4.0
/
Axiom®
Ø4.8
Ø5.2
Blue
Anthofit®
Ø4.5
Ø5.0
Purple
Axiom®
Ø5.4
/
Brown
Axiom®
Ø6.0
/
The coloured ring on the Axiom® TL countersinks corresponds to the colour of the ring of the last drill used (guiding diameter). The hard bone instruments and the kit containing them are differentiated from other instruments and kits by two black lines laser marked.
Compatibility of the Axiom® implant screwing instruments:
Marker
Compatible implant types
Grey instruments
Axiom® BL implant
Gold instruments
Axiom® TL implant
Warning: The use of instruments that are not suitable for the implant can damage the implant connection.
Compatibility of the prosthetic tightening instruments:
Marker
Compatible component types
Screw with hexagonal recess "HEXA" marking
Novaloc abutment
"BALL" marking Screw or lock 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 instrument types
Instruments with a blue dot
Sleeve Ø3.6
Instruments with a purple dot
Sleeve Ø4.2
Instruments with a brown dot
Sleeve Ø5.0
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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
Mini implant stops
Mini implant twist drill and initial drill
Compatibility of the INGPPA drilling guide: The drilling guide (Ref. INGPPA) is only compatible with Axiom® BL implants. Using the guide for Axiom® TL implants could damage the internal connection of the implant. The drilling guide is only compatible with the Ø1.5 mm pointer drill (Ref. OPPO15).
10. Cleaning and disinfection
Anthogyr instruments are delivered non-sterile.
They must be cleaned and decontaminated
before use and after each use for reusable
components. Do not use the components if the
packaging is opened or damaged. Before
treatment, remove the components from their
packaging. Anthogyr recommends following the
protocol described in the cleaning and
sterilisation
manual
available
at
ifu.anthogyr.com or on request from Anthogyr
at the above address.
For sterilisation, see the "Sterilisation" section.
11. Sterilisation Anthogyr instruments delivered non-sterile must be sterilised before use. Anthogyr recommends following the protocol described in the cleaning and sterilisation manual available at ifu.anthogyr.com or on request from Anthogyr at the above address. After the sterilisation was done, asepsis rules must be followed.
12. 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.
13. 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 Product lifespan
Ø2.0 pin drill
10 uses
Initial
Pointer drills
10 uses
Initial drills
10 uses
Ø2.0 pin drill
10 uses
Gingival cutters
10 uses
Bone mill
10 uses
Integral
Cortical bur Pointer drills
10 uses 10 uses
Initial drills
10 uses
Step drills
10 uses
Taps
10 uses
Anthogyr Guiding System
Gingival cutters Step drills Taps
10 uses 10 uses 10 uses
Countersinks
20 uses
Pointer drills
20 uses
Round bur
20 uses
Axiom® Multi Level®
Lindemann bur Initial drills Step drills
20 uses 20 uses 20 uses
Cortical drills
20 uses
Taps
20 uses
Drills
20 uses
Axiom® 2.8
Tap Gingival cutter
20 uses 20 uses
Mini implant
Twist drills Countersinks
20 uses 15 uses
Initial drills
15 uses
Anthofit®
Twist drills Taps
15 uses 15 uses
Taps
15 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 Product lifespan
Initial and Integral guided surgery
Anthogyr Guiding System
Ø2.0 fixation pin
250 uses, except in the case of breakage or significant deterioration causing the tool to mal-
Sleeves Spoons Sliders
Single use 250 uses 250 uses
Implant fixation screw
250 uses, unless thread damage
Drill stops
250 uses
Axiom®
Guiding pin
Multi Level® Gauges
250 uses 250 uses
Axiom® 2.8
Drilling guides Gauges
250 uses 250 uses
Mini implant
Gauge Drill stops
250 uses 250 uses
Anthofit® Gauges
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
Implant screwing wrenches
Implant screwing mandrels
Product lifespan 50 uses 50 uses
Anthogyr Guiding
Implant screwing mandrels
250 uses
Implant screwing wrenches
Implant holder
Implant screwing mandrels
Axiom®
Universal instrument
Multi Level® mandrels
Prosthetic screwing wrenches
Prosthetic screwing mandrels
250 uses 250 uses 250 uses 100 uses 250 uses 250 uses
Mandrel extension
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.).
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Range
Anthogyr Guiding
Type of device Product lifespan
Analog positioning tool
Single use
Axiom® Multi Level®
AA screw gripper
Single use
Axiom® 2.8 Gripper tools
250 uses
One use is equivalent to one reprocessing cycle.
Kits 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 Initial
Type of device Product lifespan
Guided surgical kit
250 uses
Integral
Guided surgical kits
50 uses
Anthogyr Guiding
Guided surgical kit
250 uses
Axiom® Multi Level®
Surgical kits Prosthesis kits Stop kits
250 uses 250 uses 250 uses
Axiom® 2.8 Surgical kit
250 uses
Mini implant Surgical kit
250 uses
Anthofit®
Surgical kit Prosthesis kit
250 uses 250 uses
One use is equivalent to one reprocessing cycle.
14. 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 see:
Initial guided surgery - Anthogyr INITIAL Guided Surgery user guide (AXIOM-GID_NOT)
Integral guided surgery: - Anthogyr INTEGRAL Guided Surgery user guide (AXIOM-INT_NOT)
Anthogyr Guiding System: - ANTHOGYR Guiding System Axiom® BL user guide (AGS-R-PX_NOT)
Axiom® Multi Level®: - Axiom® Multi Level® surgical user guide (AXIOM-MLC_NOT) - Axiom® Multi Level® Prosthetic user guide (AXIOM-MLP_NOT) - Axiom® BL X3 surgical user guide (AXIOMX3C_NOT)
Axiom® 2.8: - Axiom® BL 2.8 user guide (AXIOM2-8_NOT)
Mini implant: - Mini implant user guide (MIO_NOT)
Anthofit®: - Anthofit® HE surgical user guide (ANTHOFITHEC_NOT) - Anthofit® HE prosthetic user guide (ANTHHEP_NOT)
Others: - Cleaning and sterilisation user guide (NETTSTE_NOT) - Axiom® REG and PX User guide (AXIOMRPX_NOT)
15. 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.
16. Waste treatment Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.
17. 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. Patients must be advised to remain cautious for the first few weeks after surgery.
18. 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 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.
19. 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. 20. Availability Some components of the Anthogyr implant system are unavailable in certain countries.
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21. 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
A Manufacturer
ISO 15223-1
B Date of manufacture
ISO 15223-1
N Catalogue number
ISO 15223-1
O Batch code
ISO 15223-1
P D b
G
]only V
Serial number Consult instructions for use or consult electronic instructions for use Medical Device
CE marking - compliance with current regulations
FDA certification logo Use-by date
ISO 15223-1
ISO 15223-1
PR 15223-1 (2020) Directive 93/42/CEE ------------ MDR (EU) 2017/745 21 CFR 801.109(b)(1)
ISO 15223-1
c Single sterile barrier system ISO 15223-1
a
Single sterile barrier system with protective packaging ISO 15223-1 inside
S Sterilized using irradiation ISO 15223-1
? Do not resterilise
ISO 15223-1
F Non-sterile
ISO 15223-1
Sterilizable in a steam
g sterilizer (autoclave) at temperature specified
ISO 7000 2868
Non sterilizable in a steam
ù sterilizer (autoclave) at
Anthogyr
temperature specified
Do not use if packaging is
X damaged and consult instructions for use
ISO 15223-1
Y Keep away from sunlight
ISO 15223-1
W Do not re-use.
ISO 15223-1
E Caution
ISO 15223-1
f Contains hazardous
n Screwing torque
ISO 15223-1 Anthogyr
Axiom® BL countersink + pin Anthogyr
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