Screwdrivers Instructions for Use

At Surgery: Care and maintenance of sterile instruments are crucial for a successful treatment. Sterilized instruments not only safeguard your patients and staff against infection but are also essential for the outcome of the total treatment. Because of the small sizes of the devices, care must be taken that they are not swallowed or aspirated by the patient. It is appropriate to use specific supporting tools to prevent aspiration of loose parts (e.g. gauze, dental dam, or a throat shield).

Materials: Screwdrivers Omnigrip™, Omnigrip™ Mini and Unigrip™ (Manual and Machine): Stainless steel AISI 303 / AISI 304 / 420F Mod according to ASTM F899, with titanium nitride (TiN) coating. Screwdrivers Multi-unit (Manual and Machine) and Cover Screw Brånemark System Hexagon: Stainless steel AISI 303 / AISI 304 / 420F Mod according to ASTM F899.

Sterility and Reusability Information:

The screwdrivers are to be used in patients subject to dental implant treatment.

Sterility and Reusability Claims for Product Category II: Screwdrivers delivered non-sterile and are intended for reuse. Prior to use clean and sterilize the product following the manual or automated procedure in the Cleaning and Sterilization Instructions.

Clinical Benefits and Undesirable Side Effects:

Warning: Use of non-sterile device may lead to infection of tissues or infectious diseases.

Intended Users and Patient Groups: The screwdrivers are to be used by dental health care professionals.

Clinical Benefits Associated with Screwdrivers: Screwdrivers are components of treatment with a dental implant system and/or dental crowns and bridges. As a clinical benefit of treatment, patients can expect to have their missing teeth replaced and/or crowns restored. Undesirable Side Effects Associated with Screwdrivers: The use of this device is part of an invasive treatment which may be associated with typical side effects such as inflammation, infection, bleeding, hematoma, pain, swelling. Depending on location it may also lead in rare cases to fenestration or fracture of bone, perforation of neighboring structures, sinusitis, or sensory/motor disturbances. During use of this device the pharyngeal (gag) reflex may be triggered in patients with a sensitive gag reflex. Notice regarding serious incidents: For a patient/user/third party in the European Union and in countries with an identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. The contact information for the manufacturer of this device to report a serious incident is as follows: Nobel Biocare AB

If with slight pressure the Screwdriver Omnigrip and Omnigrip Mini do not engage in the respective screw, the screwdriver is worn and shall be discarded. Warning: Do not use device if the packaging has been damaged or previously opened.

Handling Procedure: Manual Screwdrivers: Note: Prior to use, loop dental floss through the hole in the handle of the manual screwdriver to prevent dropping the instrument, potentially into the mouth of the patient where it may be aspirated or swallowed. Engage the screwdriver to the screw or component with light pressure.

2. Tighten or loosen the screw/component by hand. Machine Screwdrivers: 1. Connect the screwdriver to the Manual Torque Wrench Adapter Prosthetic. 2. Engage the screwdriver to the screw or component with light pressure. 3. Connect the Manual Torque Wrench Prosthetic to the screwdriver/wrench adapter assembly and tighten the screw/component to the recommended tightening torque. For the maximum tightening torque of the screws or components which are compatible with the screwdrivers refer to the IFU for the screw/component. The maximum allowed tightening torque of the screwdrivers is presented in Table 3. Table 3: Maximum Tightening Torque for Machine and Manual Screwdrivers

Note: It is recommended to perform the automated cleaning and drying with a maximum load of 11 individual devices. 1.

Place the devices in a suitable rack or load carrier (e.g. metal sieve basket).

2. Load the devices into the washer. Ensure the rack or load carrier is oriented in a horizontal position. 3. Perform automatic cleaning. The following parameters are based on the Vario TD program on the Miele G7836 CD washer: ●

Minimum 2 minutes pre-cleaning with cold tap water.

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Draining.

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Minimum 5 minutes cleaning with minimum 55°C (131°F) tap water and 0.5% mildly alkaline detergent (e.g. Neodisher Mediclean). Draining.

●

Minimum 3 minutes neutralization with cold desalinated water.

●

Draining.

●

Minimum 2 minutes rinsing with cold desalinated water.

●

Draining.

The devices can be cleaned manually, or in an automatic washer. Each device must then be individually sealed in a sterilization pouch and sterilized.

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Manual and Automated Cleaning: AAMI TIR 12.

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Sterilization: AAMI ST79 and ISO 17665-1.

According to EN ISO 17664, it is the responsibility of the user/processor to ensure that the processing/reprocessing is performed using equipment, materials and personnel which are suitable to ensure the effectiveness of the processes. Any deviation from the following instructions should be validated by the user/processor to ensure the effectiveness of the process. Note: The manufacturer's instructions for use for any detergent / cleaning solution and/or equipment and accessories used to clean and/or dry the device(s) must be strictly followed where applicable. Note: The Screwdrivers have been validated to withstand these cleaning and sterilization procedures. Caution: Do not deviate from the following reprocessing instructions. Caution: Keep dissimilar metals separated during sterilization to resist corrosion. Initial Treatment at Point of Use Prior to Reprocessing: 1. Discard single-use instruments and worn reusable instruments immediately after use.

Maximum Tightening Torque 35 Ncm

3. Rinse the devices with cold running tap water.

Omnigrip™ Mini

20 Ncm

Unigrip™

35 Ncm

Multi-unit

35 Ncm

Cover Screw Brånemark® System Hexagon

Hand-tighten

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Automated Cleaning and Drying: The following washer was used in the Nobel Biocare validation: Miele G7836 CD with the Vario TD program.

●

Omnigrip™

Note: Machine screwdrivers can be connected to the Handle for Machine Instruments instead of the torque wrench, and can then be used manually. Refer to Nobel Biocare IFU1090 for more information regarding the Handle for Machine Instruments.

6. Rinse lumina (where applicable) with 20 ml tap water using a 20 ml syringe.

Screwdrivers are delivered non-sterile by Nobel Biocare and are intended for reuse. Prior to each use, the devices must be cleaned and sterilized by the user.

Screwdriver

Caution: In case the Screwdriver Omnigrip™ or Omnigrip™ Mini is used at an angulation to the screw and slips out of the interface, increase the axial force applied on the screwdriver, or try reducing the angulation of the screwdriver to the screw.

5. Thoroughly rinse all outer and inner surfaces, lumina and cavities (where applicable) with cold running tap water for a minimum of 10 seconds to remove all cleaning solution.

Cleaning and Sterilization Instructions:

2. Remove excess soil and debris from reusable devices to be reprocessed using absorbent paper wipes. Use a dental probe to remove soil and debris from cavities, where applicable.

Caution: Never exceed recommended maximum tightening torque in applicable instructions for use of the surgical or prosthetic screw/component. Overtightening of the screw may lead to a screw fracture and/or damage of the component.

4. Brush the inner surfaces, lumina and cavities (where applicable) with an appropriately sized bottle brush (e.g. 1.2 mm / 2.0 mm / 5.0 mm diameter) for a minimum of 20 seconds until all visible soil is removed.

Note: Screwdrivers can be processed as individual devices as described in the Cleaning and Sterilization Instructions below, or together with other devices in a PureSet tray following the cleaning and sterilization instructions in Nobel Biocare Instructions for Use (IFU) IFU1067. This IFU is available on ifu.nobelbiocare.com.

The following cleaning and sterilization processes have been validated according to international standards and guidelines as applicable:

https://www.nobelbiocare.com/complaint-form

1.

The screwdrivers are reusable instruments which shall be inspected before each re-use to ensure that the integrity and performance continues to be maintained. Check if any wear, abrasion of the coating, deformations or corrosion is visible on the instrument. Screwdrivers showing those signs shall be discarded.

3. Brush the outer surfaces with a soft bristled nylon brush (e.g. Medsafe MED-100.33) for a minimum of 20 seconds until all visible soil is removed.

Containment and Transportation/Shipping to Reprocessing Area: 1. After removal of excess soil and debris, store the devices in a container which is suitable to protect the devices during transportation and to avoid any contamination of personnel or the environment. 2. Transport the devices to the reprocessing area as soon as practical. If transfer to the processing area is likely to be delayed, consider covering the devices with a damp cloth or store it in a closed container to avoid drying of soil and/or debris. Note: Reusable devices should be reprocessed by initiating the prescribed automated or manual cleaning and drying procedures within 1 hour of use, to ensure the efficacy of the reprocessing. 3. If the devices are shipped to an outside facility for reprocessing, they must be contained in a transportation or shipping container which is suitable to protect the devices during transportation and to prevent contamination of personnel or the environment. Automated Cleaning and Drying (Including Pre-cleaning): Pre-cleaning: 1. Immerse the device in 0.5% lukewarm enzymatic cleaning agent (e.g. Neodisher Medizym) for a minimum of 5 minutes. 2. Fill lumina (where applicable) with 0.5% lukewarm enzymatic cleaning agent (e.g. Neodisher Medizym) using a 20 ml syringe.

4. Run drying cycle at minimum 50°C (122°F) for a minimum of 10 minutes. 5. Dry with compressed air or clean and lint-free single use wipes, if any residual moisture remains after the drying cycle. Visual Inspection: After cleaning and drying, inspect the device for unacceptable deterioration such as corrosion, discoloration, pitting, or cracked seals and properly discard any devices that fail the inspection. Manual Cleaning and Drying: 1. Immerse device for a minimum of 5 minutes in a sterile 0.9% NaCl solution. 2. Scrub the outer surfaces of the device with soft-bristled nylon brush for a minimum of 20 seconds until all visible soil is removed. 3. Flush the inner surfaces, lumina and cavities (where applicable) with 20 ml lukewarm enzymatic cleaning solution (e.g. Cydezyme ASP; maximum 45°C (113°F)) using an irrigation needle connected to a 20 ml syringe. 4. Brush the inner surfaces, lumina and cavities (where applicable) with appropriately sized bottle brush (e.g. 1.2 mm / 2.0 mm / 5.0 mm diameter) for a minimum of 10 seconds until all visible soil is removed. 5. Thoroughly rinse the outer surfaces and lumina of the device with cold running tap water for a minimum of 10 seconds to remove all cleaning solution. 6. Immerse the device in an ultrasonic bath (e.g. Bandelin; frequency 35 kHz; effective ultrasonic power 300 W) containing 0.5% enzymatic cleaning agent (e.g. Cydezyme ASP) and treat for a minimum of 5 minutes at minimum 40°C (104°F) / maximum 45°C (113°F). 7.

Flush the inner surfaces, lumina and cavities (where applicable) with 20 ml lukewarm tap water using an irrigation needle connected to a 20 ml syringe.

8. Thoroughly rinse the outer surfaces of the device with purified or sterile water for a minimum of 10 seconds to remove all cleaning agent. 9. Dry with compressed air or clean and lint-free single use wipes. Visual Inspection: After cleaning and drying, inspect the device for unacceptable deterioration such as corrosion, discoloration, pitting, cracked seals and properly discard any devices that fail the inspection. Sterilization: The following steam sterilizers were used in the Nobel Biocare validation: Systec HX-320 (pre-vacuum cycle); Amsco Century Sterilizer (gravity cycle). Note: It is recommended to perform sterilization with a maximum load of 11 devices individually sealed in sterilization pouches. 1.

Seal each device in a suitable sterilization pouch. The sterilization pouch should fulfill the following requirements: ●

EN ISO 11607 and/or DIN 58953-7.

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●

●

Suitable for steam sterilization (temperature resistance up to at least 137°C (279°F), sufficient steam permeability). Sufficient protection of the instruments as well as of the sterilization packaging to mechanical damage.

Table 4 presents examples of suitable sterilization containers, pouches, and wraps. Method

Recommended Sterilization Pouch

Gravity Cycle

SPSmedical Self-Seal sterilization pouch

Pre-vacuum Cycle

SteriCLIN® pouch

2. Label the sterilization pouch with information necessary to identify the device (for example, the product name with article number and lot/batch number (if applicable)). 3. Place the sealed sterilization pouch into the autoclave/sterilizer. Ensure that the sterilization pouch is oriented in a horizontal position. 4. Sterilize the device. Both the gravity displacement cycle and pre-vacuum (top dynamic air removal) cycle can be applied, using the following recommended parameters (Table 5): Table 5: Recommended Sterilization Cycles Minimum Temperature

Minimum Sterilization Time

Minimum Drying Time (In Chamber)

Minimum Pressure

20 minutes

≥2868.2 mbar4

132°C (270°F)

15 minutes

1

132°C (270°F)

4 minutes

Pre-Vacuum Cycle2

134°C (273°F)

3 minutes

Pre-Vacuum Cycle3

134°C (273°F)

18 minutes

Gravity Cycle1 Pre-Vacuum Cycle

Symbols Glossary:

The device must be stored and transported in dry conditions in the original packaging at room temperature and not exposed to direct sunlight. Incorrect storage and transportation may influence device characteristics leading to failure.

The following symbols may be present on the device labeling or in information accompanying the device. Refer to the device labeling or accompanying information for the applicable symbols.

Disposal:

Table 4: Recommended Sterilization Pouches

Cycle

Storage, Handling and Transportation:

≥3042 mbar5

1

 alidated sterilization processes to achieve a Sterility Assurance Level (SAL) of 10-6 in accordance to V EN ISO 17665-1.

2

Recommendation of the Welsh Health Technical Memorandum (WHTM) 01-01 Part C.

3

 ecommendation of the World Health Organization (WHO) for steam sterilization of instruments with potential R TSE/CJD contamination. Ensure that the packaging and monitoring systems (chemical/biological indicators) used for this cycle are validated for these conditions.

4

Saturated steam pressure at 132°C as per required by EN ISO 17665-2.

5

Saturated steam pressure at 134°C as per required by EN ISO 17665-2.

Note: Autoclave/sterilizer design and performance can affect the efficacy of the sterilization process. Healthcare facilities should therefore validate the processes that they use, employing the actual equipment and operators that routinely process the devices. All autoclaves/ sterilizers should comply with the requirements of, and be validated, maintained and checked in accordance to SN EN 13060, EN 285, EN ISO 17665-1, and/or AAMI ST79, or to the applicable national standard. The autoclave/sterilizer manufacturer's instructions for use must be strictly followed.

Safely discard potentially contaminated or no longer usable medical devices as healthcare (clinical) waste in accordance with local healthcare guidelines, country and government legislation or policy. Separation, re-cycling or disposal of packaging material shall follow local country and government legislation on packaging and packaging waste, where applicable.  anufacturer: M Nobel Biocare AB Box 5190, 402 26 Västra Hamngatan 1 411 17 Göteborg Sweden www.nobelbiocare.com Distributed in Australia by: Nobel Biocare Australia Pty Ltd Level 4/7 Eden Park Drive Macquarie Park, NSW 2114 Australia Phone: +61 1800 804 597 Distributed in New Zealand by: Nobel Biocare New Zealand Ltd 33 Spartan Road Takanini, Auckland, 2105 New Zealand Phone: +64 0800 441 657

CE Mark for Class I Devices

CE Mark for Class IIa Devices

73327470000001787L 73327470000001787L

Screwdrivers Manual Unigrip™

73327470000001787L

Screwdrivers Manual Multi-unit

73327470000001787L

Screwdriver Manual Multi-unit Brånemark System WP

73327470000001787L

Cover Screw Driver Brånemark System Hexagon

73327470000001787L

Omnigrip™ Screwdrivers Machine

73327470000001797N

Screwdrivers Machine Omnigrip™ Mini

73327470000001797N

Screwdrivers Machine Unigrip™

73327470000001797N

Performance Requirements and Limitations:

Screwdriver Machine Multi-unit

73327470000001797N

To achieve the desired performance, the screwdrivers must only be used with the products described in this Instructions for Use and/or in the Instructions for Use for other compatible Nobel Biocare products, and in accordance with the Intended Use for each product. To confirm the compatibility of products which are intended to be used in conjunction with the screwdrivers, check the color coding, dimensions, lengths, connection type and/or any direct marking as applicable on the products or product labeling.

Screwdriver Machine Multi-unit Brånemark System WP

73327470000001797N

Facilities and Training: It is strongly recommended that clinicians, new as well as experienced implant users, always go through special training before undertaking a new treatment method. Nobel Biocare offers a wide range of courses for various levels of knowledge and experience. For more info please visit www.nobelbiocare.com.

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CE mark

CE mark with Notified Body number

Consult instructions for use

Contains hazardous substances

Implantation date

Date of manufacture

Do not re-sterilize

Do not re-use

Do not use if package is damaged

Double sterile barrier system

For prescription use only

Health care centre or doctor

Keep away from sunlight

Keep dry

Link to Online Symbols Glossary and IFU Portal

Magnetic resonance conditional

Manufacturer

Medical device

Non-pyrogenic

Non-sterile

Patient identification

Patient information website

Patient number

Contains or presence of DEHP phthalate

Contains or presence of phthalate

Contains or presence of natural rubber latex

Magnetic resonance safe

The following table lists the Basic UDI-DI information for the devices described in this IFU.

Screwdrivers Manual Omnigrip™ Mini

The container and/or outer packaging used to transport or ship the reprocessed device back to the point of use must be suitable to protect and safeguard the sterility of the devices during transportation, taking the device packaging and the required transportation or shipping process (intrafacility transportation or shipping to an external site) into account.

Caution

Basic UDI-DI Information:

Omnigrip™ Screwdrivers Manual

Containment and Transportation/Shipping to Point of Use:

Catalogue number

Note: Refer to the product label to determine the applicable CE mark for each device.

Basic UDI-DI Number

After sterilization, place the labeled and sealed sterilization pouch in a dry and dark place. Follow the instructions provided by the manufacturer of the sterilization pouch regarding the storage conditions and expiration date of the sterilized device.

Batch code

Manufacturer and Distributor Information:

Product

Storage and Maintenance:

Authorized Representative in the European Union

IFU1085 000 02

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Serial number

Single sterile barrier system

Single sterile barrier system with protective packaging inside

Single sterile barrier system with protective packaging outside

Sterilized using ethylene oxide

Sterilized using irradiation

Temperature limit

Tooth number

Upper limit of temperature

Sterilized using steam or dry heat

Unique Device Identifier

Use-by date

EN All rights reserved. Nobel Biocare, the Nobel Biocare logotype and all other trademarks used in this document are, if nothing else is stated or is evident from the context in a certain case, trademarks of Nobel Biocare. Product images in this folder are not necessarily to scale. All product images are for illustration purposes only and may not be an exact representation of the product.

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