Anthogyr 201 Implantology Mont Blanc Instruction Manual

Anthogyr 201 Implantology Mont Blanc

Product Information

Specifications

Product| Head Type| Light| Depth Stop System| Ratio| Colour Code| Weight (g)| Total Length (mm)| Head Height (mm)| Micromotor Connection| Maximum Speed of Micromotor (rpm)| Rotary Instrument Diameter (mm)| Maximum Rotary Instrument Torque (N.cm)| Maximum Recommended Length (mm)| Maximum Recommended Diameter (mm)| Irrigation System| Spray Water Flow (ml/min)
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---
10400X| Push button| No| No| 20 : 1| Green| 90| 103| 12.9| Rear body pin type| 40,000| 80(1)| 40| 10| External by spray attachment| > 50(2)
10400XL| Push button| Yes (optical fiber)| Yes| 20 : 1| Green| 96| 86| 12.9| Rear body pin type| 40,000| 80(1)| 40| 10| External by spray attachment| > 50(2)
16400X| Push button| No| No| 20 : 1| Green| 80| 86| 12.9| Rear body pin type| 40,000| 80(1)| 40| 10| External by spray attachment| > 50(2)
16400XL| Push button| Yes (optical fiber)| Yes| 20 : 1| Green| 86| 86| 12.9| Rear body pin type| 40,000| 80(1)| 40| 10| External by spray attachment| > 50(2)

Product Usage Instructions

Product Description
The implantology contra-angles are dental devices used in dental implantology procedures. They come in different models with varying technical characteristics.

Legend

• A – Head
• B – Push button
• C – Spray attachment
• D – Collar cartridge
• E – Optical fiber output
• F – Lever
• G – Body
• H – Depth stop holder
• I – Depth stop

Intended Use
The implantology contra-angles are intended to be used by a surgeon trained in dental implantology on fully or partially edentulous patients. They are designed for use in dental implant procedures.

Indications
The implantology contra-angles can be used for various dental implant procedures, providing precise control and efficient performance.

Patient Type and Intended User
The contra-angles should be used by a qualified dental surgeon who has received proper training in dental implantology. These devices are suitable for use on fully or partially edentulous patients who do not have any contraindications.

Contraindications
These devices should not be used on patients who have allergies or hypersensitivity to chromium, as the external parts of the contra-angles are coated with Cr plating.

Warning
Implant surgery is a complex dental procedure that requires proper techniques and knowledge. Incorrect techniques can lead to implant failure and loss of bone support. It is essential to have appropriate training, qualification, and a good understanding of surgical techniques using Anthogyr products. Anthogyr offers specific training for this purpose.

Caution / Precautions

• Prior to use, check the contra-angle for any damage or missing parts.
• Before each use, test the proper functioning of the contra-angle and its accessories outside of the patient’s mouth.
• Wear appropriate protective gear, including gloves, mask, and glasses.
• Do not use the contra-angle if there is visible failure or damage.
• Ensure proper irrigation with at least 50 ml/min of water flow at the correct temperature and orientation.
• Avoid overheating at the treatment site.
• Avoid scratching or damaging the optical fiber output.
• Use the contra-angle only with an IEC 60601-1 compliant motor/micromotor.
• If the contra-angle is not used for an extended period, disconnect it from the micromotor and wait until the micromotor comes to a complete stop before storing.

FAQ

• Q: Can the contra-angle be used with any micromotor?
  A: No, the contra-angle should only be used with an IEC 60601-1 compliant motor/micromotor.

• Q: How should I store the contra-angle when not in use?
  A: If the contra-angle is not used for a long time, it should be disconnected from the micromotor and stored after ensuring the micromotor has come to a complete stop.

• Q: What should I do if I notice visible damage or failure in the contra-angle?
  A: If you notice any visible damage or failure in the contra-angle, do not use it and contact your distributor or Anthogyr After Sales Department for assistance.

Instructions for use

Legend

• A Head
• B Push button
• C Spray attachment
• D Collar cartridge
• E Optical fiber output
• F Lever
• G Body
• H Depth stop holder
• I Depth stop

Product description

These instructions for use apply to the Mont Blanc® implantology range. This range regroups several contra-angles and accessories. Contra-angles are mechanical instruments with an angle transmission. They need to be connected to a micromotor in order to drive the rotary instrument that is inserted in the contra-angle head.

Technical characteristics of each contra-angle are detailed in the table below:

10400X| 10400XL| 10400XLI| 10401X| 10401XL| 16400X| 16400XL| 16400XLI
---|---|---|---|---|---|---|---
Head type| Push button
Light| No| Yes (optical fiber)| No| Yes (optical fiber)| No| Yes (optical fiber)
Depth stop system| No| Yes| =No
Ratio| 20 : 1
Colour code| Green
Weight (g)| 90| 96| 96| 90| 96| 80| 86| 86
Total length (mm)| 103| 86
Head height (mm)| 12.9
Micromotor connection according to NF EN ISO 3964| Coupling| Long| Short
Type| 1| 4| 1| 4| 1| 4
Rear body pin type| NA| retractable| rigid| NA| retractable| NA| retractable| rigid
Maximum speed of micromotor (rpm)| 40 000
Rotary instrument diameter (mm) and type according to NF EN ISO 1797| Ø2.35 Type 1
Maximum rotary instrument torque (N.cm)| 80(1)
Maximum recommended length (mm)| 40
Maximum recommended diameter (mm)| 10
Irrigation system| External by spray attachment Internal by Kirschner-Meyer needle
Spray water flow (ml/min)| > 50(2)

1. This torque can be reached provided the motor used is powerful enough. It is generally possible to limit the torque on the control unit.
2. Values obtained with at least 50% flow programmed on the Anthogyr motors.

Intended use
Mont Blanc® implantology contra-angles are intended to transmit rotation from the power source at a reduction gear ratio of 20:1, thereby running the rotary instrument needed for implantology surgery.

Indications
Mont Blanc® implantology contra-angles are indicated to drive rotary instruments used for dental implantology treatment: implant bed preparation and placement of implants.

Patient type and intended user

• These devices must be used by a surgeon trained in dental implantology on fully/partially edentulous patients who do not present any of the conditions mentioned in the “Contraindications” section.
• These devices may be reprocessed by a dental assistant according to the following instructions.

Contraindications
Allergy or hypersensitivity to chromium (the external parts of the contra- angles are coated with Cr plating).

Warning

• Implant surgery is a complex dental procedure. Incorrect techniques can cause implant failure and/or loss of bone support.
• Appropriate training and qualification and a good knowledge of surgical techniques with Anthogyr products are required. Anthogyr offers specific training.

Caution / Precautions

• Prior to use, check that the device has not been damaged in any way and that no parts are missing.
• Before each use, check the proper functioning of the contra-angle and its accessories outside of the patient’s mouth.
• Wear appropriate protection, especially gloves, mask and glasses.
• Do not use the contra-angle and inform your distributor or Anthogyr After Sales Department in the following situations:
  • visible failure or damage;
  • non-existent or insufficient irrigation (at least 50 ml/min, at the correct temperature and oriented in an optimum manner). Always ensure that a sufficient and adequate spray water flow is delivered. Avoid overheating at the treatment site;
  • scratching of, or damage to, the optical fiber output.
• Use the contra-angle only with an IEC 60601-1 compliant motor/micromotor. In the event of prolonged non-use of the contra-angle, do not leave it connected to the micromotor.
• Wait until the micromotor comes to a complete stop before:
  • connecting/disconnecting the contra-angle from the micromotor;
  • assembling/disassembling the contra-angle;
  • applying pressure to the push button;
  • handling/changing the rotary instrument.
• Assess the risk of septic substances penetrating tissue if used with a central air-cooled motor (refer to the motor manufacturer’s leaflet).
• Regarding displayed torque values on the motor unit, please make sure the motor is set properly according to the motor manufacturer’s instructions.
• Do not exceed 2N (about 200g) by applying pressure to the contra-angle with a rotary instrument (refer to the rotary instrument manufacturer’s instructions).
• For light-equipped versions, risk of dazzle:
  • Do not look directly at the light output
  • Do not point the light directly into the eyes of the patient or third parties. The lighting level can generally be adjusted by the motor.

The following situations relieve Anthogyr of all warranty obligations or other claims:

• Inappropriate use
• Lack of maintenance
• Use of removable accessories or parts not approved by Anthogyr
• Using accessories from other devices on this Medical Device
• Change or addition to the Medical Device made by the user.

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 Mont Blanc® implantology range 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
• damage to natural tooth
• discomfort
• electric shock
• eye damage
• hypersensitivity / allergic reaction
• implant fracture
• local or systemic infection (including peri-implantitis, periodontitis, gingivitis, fistula)
• injuries of gingiva
• irritation / inflammation
• local pain
• longer recovery / healing time than expected
• loss of implant
• nerve damage possibly resulting in chronic pain
• poor aesthetic outcome
• possibility of prolongation of intervention
• possibility of prolongation of surgery
• possibility to swallow / inhale small parts during the procedure
• recall to the dentist’s office
• sinus perforation

Side effects:

• swelling
• local inflammation
• bruising
• resorption of maxillary/mandibular ridge bone
• local infection
• minor bleeding

Compatibility information

Accessories for Mont Blanc® Implantology contra-angles are available and compatible according to the table below:

*by first removing the depth stop holder from the contra-angle head

Reprocessing

Single-use spray attachment

• Single-use spray attachments ref. 10476 (the green ones) are supplied sterile (gamma sterilisation) and are identified with an logo. They are intended for single use. Do not clean or sterilise these spray attachments. Cleaning, disinfection and sterilisation can compromise the essential material and design features of the medical device and result in device failure.
• Check that the entire packaging of the device is undamaged before opening. A device with damaged packaging must not be used. It is recommended to have a replacement device readily available for use. The intact packaging protects the sterilised device against any external influence and, if stored properly, guarantees sterility until the expiry date indicated on the packaging. The pack must not be opened before the device is used. When removing the device from the sterile packaging, asepsis rules must be followed.
• Anthogyr declines all responsibility for re-sterilised components, regardless of who carried out the re-sterilisation or the method used. Under no circumstances should a previously used or non-sterile device be placed in the patient’s mouth. If the original packaging is damaged, Anthogyr will not accept the return of the device.
• Contra-angles and other accessories delivered non-sterile
• The reusable MD needs to be reprocessed before first use and after each use.
• After patient care, the contra-angle should be processed as soon as possible, at the latest within two hours.
• To avoid any risk of infection or injury, it is imperative that users wear protective clothing (mask, gloves, and protective goggles).
• 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.

MANUAL CLEANING:
CIDEZYME™ (ASP) at a concentration of 8mL/L.

AUTOMATIC CLEANING:

• Enzymatic detergent: n eodisher® MediClean Dental (Dr. Weigert) at a concentration of 2mL/L.
• Neutraliser: neodisher® Z Dental (Dr. Weigert) at a concentration of 1mL/L.

Anthogyr recommends following the protocol below:

• Prepare the device
  To be done immediately after surgery:

  • Disconnect the contra-angle from the micromotor while keeping them in alignment
  • Remove the rotary instrument
  • Lubricate the contra-angle if cleaning cannot be carried out quickly to remove excess soiling

• Disassemble the device (Fig. 1)

  • Remove the accessories (i.e. spray attachment C)
  • Pivot the lever F up to the stop:
  • towards the right for contra-angle ref. 16400XL / 16400XLI (Fig. 3)
  • towards the right or the left for other contra-angles
  • Pull the head A
  • Remove the collar cartridge D
  • Do not disassemble any parts other than those indicated.

• Cleaning

  • Carefully clean the irrigation pipe and remove any impurities and deposits from it using the spray drain cleaner.
  • Light-equipped versions (optical fiber):
  • Do not scratch the optical fiber
  • Install light input/output protections on the body (Fig. 7) to protect the optical fiber
  • Proceed to the cleaning step by choosing manual cleaning or automatic cleaning:

Manual cleaning
Follow the protocol below:

• Use a soft nylon brush to brush all surfaces under tap water at room temperature (20 ± 5°C) for at least 1 minute. Use an adapted nylon brush for hard-to-reach areas.
• Soak a soft nylon brush in a solution of CIDEZYME™ Enzymatic detergent at a concentration of 0.8% at room temperature (20 ± 5°C) and brush all surfaces for at least 3 minutes.
• Rinse under running tap water at room temperature (20 ± 5°C) for at least 1 minute.
• Rinse with purified water* at room temperature (20 ± 5°C) for at least 1 minute. During rinsing, brush all surfaces with a soft nylon brush for at least 30 seconds.
• If not dry, use a soft lint-free wipe.

*The water used for cleaning, diluting detergents, and rinsing should be monitored. It is recommended that highly purified water be used, according to the specifications of the local pharmacopoeia.

Automatic cleaning
Only for an MD engraved with the thermal disinfection logo

Follow the protocol below:

• Manual pre-cleaning
  • Use a soft-nylon brush to brush all surfaces under tap water at room temperature (20 ± 5°C) for at least 30 seconds. Use an adapted nylon brush for hard-to-reach areas.
  • Soak a soft-nylon brush in a solution of CIDEZYME™ Enzymatic detergent at a concentration of 0.8% at room temperature (20 ± 5°C) and brush all surfaces for at least 1 minute.
  • Rinse under running tap water at room temperature (20 ± 5°C) for at least 20 seconds.
• Automatic cleaning
  • Place the devices in the washing racks without overloading them.
  • Use a validated washer disinfector. Use the cycle parameter set points mentioned in the following table:

Cycle| Temperature| Duration| Cleaning agent| Detergent and concentration
---|---|---|---|---
Pre-Cleaning| Cold (<45°C)| 2 min| Tap water| NA
Cleaning| Heated (50-60°C)| 5 min| Enzymatic detergent| neodisher® MediClean Dental (2mL/L)
Neutralisation| Cold (<45°C)| 1 min| Neutraliser| neodisher® Z Dental (1mL/L)
Rinsing| Cold (<45°C)| 1 min| Tap water| NA
Thermal rinsing| Heated (90°C)| 5 min| Purified water*| NA
Drying| Heated (60°C)| 10 min| NA| NA

• *The water used for cleaning, diluting detergents, and rinsing should be monitored. It is recommended that highly purified water be used, according to the specifications of the local pharmacopoeia.
• Remove the devices at the end of the cleaning cycle.

Assemble the device
Only assemble parts with the same serial number.

• Attach the collar cartridge D to head A (only one direction possible) until it fully engages (turn the cog until connection if required)
• Insert the head – collar cartridge unit in the body G (insert a clean rotary instrument in the head and turn it slightly so that the cog connects)
• Bring the lever F to the central position, until it clicks into place. Make sure that the depth stop system is in the right position Check the correct assembly of the head by applying axial traction.

Lubricate the device
Follow the spray lubricant manufacturer’s instructions.

Keep away from all sources of heat or ignition. Do not smoke. Risk of inflammation. After cleaning and before each sterilisation:

• Insert the tip into the back of the contra-angle (Fig. 8)
• Cover the head of the contra-angle with a soft cloth, tissue or a wipe
• Point the head downwards
• Spray several times by firmly holding the instrument until the lubricant emerges from the head
• Wipe off excess oil with a cloth or a wipe

Perform operational test

• Connect the contra-angle to a micromotor, point the head downwards.
• Turn the micromotor on at low speed for 30s. Gradually bring up to maximum speed.
• Wipe off excess oil with a cloth or a wipe. If you notice overheating, irregularities, vibrations, or abnormal noises when using the contra-angle, immediately contact your After Sales Department and do not use the device.

Sterilise the device

• Only sterilise cleaned, lubricated and tested contra-angles.
• Anthogyr recommends class B pre-vacuum autoclave sterilisation according to standard EN 13060 for all devices bearing the logo g. All other methods are forbidden. The sterilisation device must be approved and in compliance with the applicable standards. The manufacturer’s recommendations and instructions for use should be observed.

Follow the protocol below:

• Place the device by itself in the sealed sterilisation pouch according to standard NF EN ISO 11607 and adapted to autoclave sterilisation. Follow the autoclave manufacturer’s recommendations and instructions for use and maintenance.
• Ensure proper spacing between the pouches and do not overload the autoclave.
• Run a sterilisation cycle according to the following parameters:

• Allow to cool for around 15 minutes.
• Check that the device is completely dry.
• Indicate the sterilisation date and the expiry date on the package in accordance with the data from the package manufacturer (maximum 1 month). Keep the MD in the sterilisation pouch in a clean and dry place. After sterilisation, asepsis rules must be followed.

Protocol for use

The reusable MD supplied non-sterile must be reprocessed before first use and after each use.

1. Step 1: Connect the micromotor
2. Check that the contra-angle is completely dry before connecting it to the micromotor.
3. Attach the contra-angle to the micromotor connection until it clicks into place. To this end, keep the micromotor and the contra-angle in alignment (to disconnect the contra-angle from the micromotor, apply axial traction in the micromotor axis). Light-equipped versions: turn the contra-angle until the pin engages in the notch of the micromotor (Fig. 4).
4. Apply light traction to the contra-angle to check that it is properly attached to the micromotor connection.
5. Perform an operational test by switching on the motor; start at low speed, then gradually increase.
6. If you notice overheating, irregularities, vibrations, or abnormal noises when using the contra-angle, immediately contact your After Sales Department and do not use the device.
7. Step 2: Connect the irrigation
8. Attach the spray attachment C to the head A of the contra-angle.
9. Connect the extremity of the irrigation pipe to the spray attachment (Fig. 5).
10. Step 3: Insert the rotary instrument
11. Check the compatibility (diameter, type) and the condition of the rotary instrument. Check regularly that the push button is set properly by checking that it does not unscrew by hand.
12. Apply pressure using your thumb to the centre of the push button and simultaneously insert the rotary instrument up to the stop in the head of the contra-angle (Fig. 6).
13. Release the thumb pressure on the push button.
14. Before each use, apply slight traction to the rotary instrument to verify that it is correctly installed.
15. Step 4: Adjust the depth stop
16. Adjust the depth stop outside of the patient’s mouth:
17. Move the sliding block backward (no. 1 on Fig. 2) and move stop I to the required position (no. 2 on Fig. 2).
18. Release the sliding block.
19. After each adjustment, check the stop has been correctly placed using the ruler. Before each use, apply slight traction to stop I to verify that it is correctly installed. Do not use the depth stop for tapping: the bone may be damaged if stopping of the driving motor is delayed.

Lifespan of products

Contra-angles and accessories, except the spray attachment ref. 10476, 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.).

One use is equivalent to one reprocessing cycle.

Further information
For more information on the use of Anthogyr products, please contact your local Anthogyr sales representative or contact Anthogyr After Sales Department or visit ifu.anthogyr.com and www.anthogyr.com .

Storage
Store these products in a clean, dry area, at ambient temperature. Improper storage may compromise the essential characteristics of the materials and design, which may lead to device failure.

Waste treatment

• Sterilisable devices and accessories must be handled as medical waste under the responsibility of the user.
• The MD must be sterilised before disposal. Risk of contamination of third parties. Comply with legislation and national standards and guidelines for disposal.

After sales service / Warranty

• 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.
• Anthogyr products are part of a complete range and must be used in combination with the corresponding original components 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 your approved distributor or our After Sales Department directly.
• Repairs must only be carried out by an approved repairer or by Anthogyr After Sales Department only with Anthogyr original replacement parts.
• For all revisions or repairs, the contra-angle must be returned complete and sterile with proof of sterility. It must be accompanied by a document outlining the problem and showing the complete contact details of the user.
• The replacement of removable parts is covered for 7 years from the date of invoice.
• Contra-angles are guaranteed for parts and labour against all manufacturing defects for 12 months from the date of invoice. This guarantee does not apply to wear. All changes or additions to the product without the express agreement of Anthogyr render this guarantee null and void.
• The guarantee becomes null and void if the technical instructions are not followed. Anthogyr cannot be held responsible for damage resulting from, or which could result from, normal wear, misuse, incorrect cleaning or maintenance, the non-observance of instructions for use or connection, scaling or corrosion, impurities in the water supply system or unusual chemical or electrical influences or non-observance of the instructions, maintenance instructions and assembly of Anthogyr and other manufacturer’s instructions.
• Delivery charges incurred when sending an instrument back to Anthogyr for repair will be paid by the customer, even if the repair itself is covered by the guarantee. Postage and packing fees when returning the instrument to the customer are covered by the guarantee.
• So that warranty requests are taken into consideration, please attach a copy of the invoice or a copy of the delivery slip to the contra-angle.

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.

Availability
Some components of the Anthogyr Mont Blanc® range are unavailable in certain countries.

Symbols

The following table describes the symbols that may be printed on the packaging label or laser marked directly on the device. Please refer to the label on the packaging for the applicable product symbols.

NF EN ISO 15223-1

| Medical Device| NF EN ISO 15223-1
| CE marking- compliance with current regulations| Directive 93/42/CEE

——————MDR (EU) 2017/745

| U.S. federal law restricts this device to sale by or on the order of a dental professional.|

21 CFR 801.109(b)(1)

| Use-by date|

NF EN ISO 15223-1

| Single sterile barrier system| NF EN ISO 15223-1
| Sterilised using irradiation| NF EN ISO 15223-1
Symbol| Description of symbol| Source of symbol
---|---|---
| Do not resterilise| NF EN ISO 15223-1
| Non-sterile| NF EN ISO 15223-1
| Sterilisable in a steam steriliser (autoclave) at temperature specified| ISO 7000- 2868
| Do not use if packaging is damaged and consult instructions for use| NF EN ISO 15223-1
| Keep away from sunlight| NF EN ISO 15223-1
| Do not re-use| NF EN ISO 15223-1
| Caution| NF EN ISO 15223-1
| Washer-disinfector for thermal disinfection| ISO 7000 – 2785

Anthogyr

• 2237 Av. André Lasquin
• 74700 Sallanches – France
• Phone: +33(0)4 50 58 02 37
• After Sales Department : +33(0)4 50 58 50 53 www.anthogyr.com
• Email: contact@anthogyr.com
• Validity Date: 2023-02
• REF: 16310400_NOT
• Index: B

References

• Anthogyr, Instructions For Use

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