MODUS Titanium Trauma Splint System TTS Instructions for Use

• Never use products that have been damaged by transport, improper handling, or in any other way. • The TTS Tooth Splint is intended for one single application in a single patient. Splints that were used in a patient and removed must be discarded following the local requirements. Application of an already used splint may compromise the structural integrity of the splint and/or lead to device failure, which may result in patient injury. Furthermore, application of a splint that has already been used may lead to contamination, e.g. due to the transmission of infectious material from one patient to another. This could result in injury of the patient or user. Medartis assumes no liability in case of non-observance. • Splints that have not come into direct contact with a patient may be reprocessed. • Medartis recommends that if products come in contact with pathogens (confirmed or suspected) that are difficult to identify such as variant Creutzfeldt-Jakob’s disease, they must be discarded. • Intraoral appliances must be secured against aspiration. • Great care must be taken during storage and handling of the products. Damages (e.g. from improper cutting or bending) to and/or scratches on the splint can substantially impair the strength of the product and may lead to breakage of the splint. • Repeatedly bending the splint in opposite directions may cause the splint to break. • The TTS Tooth Splint has been developed and manufactured for a specific purpose and may not be modified by the user in another way than stated in these instructions for use. • The TTS Tooth Splint has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The TTS Tooth Splint has not been tested for heating or migration in the MR environment. Therefore, MR-assisted imaging techniques cannot be recommended. • The TTS Tooth Splint can cause artifacts in various imaging procedures such as computerized tomography (CT) and MR. Instructions for Selecting the Appropriate Product Medartis does not recommend specific procedures for specific patients or clinical conditions. The treating dentist is solely responsible for choosing the appropriate treatment procedure and customizing an appropriate splint for the individual case. The follow-up treatment as well as the decision of when to remove the splint is the responsibility of the user. In general, the splints are designed for temporary fixation of traumatized/replanted teeth until the periodontium has sufficiently healed. Prolonged and rigid splinting may lead to adverse effects such as ankylosis or resorption. Splinting periods should be in accordance with clinical and radiological findings. The recommended splinting period is 2-4 weeks at most. The treating dentist should become thoroughly familiarized with the procedure, for example by: • Carefully studying all the product documentation • Carefully reviewing the current scientific literature • Consulting colleagues experienced in this field and with the use of this tooth splint • Practicing handling of the TTS Tooth Splint prior to its application Handling Instructions TTS Tooth Splint application The TTS Tooth Splint is used for stabilization of traumatized/replanted teeth. The adhesive surfaces of the TTS Tooth Splint are defined by the special rhomboid openings of the splint. For sufficient stabilisation of traumatized/replanted teeth, the TTS Tooth Splint should extend over at least two healthy teeth on both sides of the tooth/teeth to be stabilized. Be careful to position the TTS Tooth Splint with distance to the gingivia. 1. Adapt the TTS Tooth Splint Adapt the TTS Tooth Splint to match the patient's dentition and shape of the dental arch. Cut the splint to the desired length (e.g. by using a crown cutter or side cutter). For sufficient stabilization of traumatized/replanted teeth, the splint should cover at least two healthy teeth on both sides of the tooth/teeth to be stabilized. Manually contour the splint to the curvature of the dental arch. Notice: No instruments must be used for bending. Caution: Do not repeatedly bend the splint in opposite directions, since this may cause the splint to break. 2. Clean the tooth surfaces Thoroughly clean, rinse and air-dry the enamel surfaces. 3. Etch the tooth surfaces Etch the enamel surfaces thoroughly with ortho-phosphoric acid according to the instructions of the bonding agent manufacturer. Rinse with water and air-dry the tooth surfaces thoroughly after etching. Caution: To allow appropriate bonded restoration, ensure to create an absolutely dry operating field. 4. Bond the tooth surfaces Apply the adhesive agent (bonding) according to the instructions of the bonding agent manufacturer. Light-cure the bonding agent as described by the manufacturer. 5. Position the TTS Tooth Splint Position the splint by hand or using tweezers. Ensure that the rhomboid openings of the TTS Tooth Splint match the etched/bonded sites. Take care to place the splint with distance to the gingiva. 6. Fix the TTS Tooth Splint with flowable composite Fix the TTS Tooth Splint to the teeth on both sides of the traumatized/replanted tooth/teeth by applying flowable composite to the rhomboid openings of the TTS Tooth Splint according to the instructions for use of the composite manufacturer. Light-cure the composite as described by the manufacturer. Reposition the traumatized/replanted tooth/teeth and bond it/them to the TTS Tooth Splint by applying flowable composite to the rhomboid openings of the TTS Tooth Splint according to the instructions of the composite manufacturer. Light-cure the composite as described by the manufacturer. 7. Final trimming of the TTS Tooth Splint Check the occlusion and check for sharp edges of the splint that could irritate the lips and soft tissues of the cheek. If necessary modify the splint (recutting), especially at its ends. Tipp: To avoid/reduce possible soft tissue irritations, cover the ends of the splint with a small amount of composite. Recommended splinting period: max. 2-4 weeks TTS Tooth Splint Removal The decision of when to remove the splint is the responsibility of the treating dentist. In general, the splint is designed for temporary fixation of traumatized/replanted teeth until sufficient periodontal healing has taken place. Prolonged and rigid splinting may lead to adverse effects such as ankylosis and resorption. Splinting periods should be in accordance with clinical and radiological findings of the individual case. The recommended splinting period is 2-4 weeks at most. 1. Remove the composite to the level of the splint using rotating instruments. Caution: Avoid grinding down to the enamel surface. 2. Hold the splint at one end and peel it off the tooth surfaces (manually or using tweezers). 3. Remove any residual composite (e.g. by using a dental curette) and refine the enamel surfaces with polishing disks. Be careful not to damage the enamel. 4. After removal of the splint, application of a fluoride-containing solution for remineralization of the etched enamel is highly recommended. Aftercare Instructions The treating dentist has to instruct the patient on appropriate hygiene procedures according to standard dental practice. Depending on the clinical and radiological findings, the treating dentist must advice the patient on possible restrictions regarding solid foods or sports following standard dental practice. Additional Information Additional information on the product can be requested from your local Medartis branch or distributor. In addition, all relevant information is provided on www.medartis.com. Instructions Regarding Cleaning, Disinfection and Sterilization The TTS Tooth Splint is delivered NON-STERILE and must be cleaned, disinfected and sterilized before use. All packaging must be removed before cleaning.Thorough cleaning and disinfection are essential for effective sterilization. It is the user's responsibility to ensure that the products are completely sterile when used, to use device- and product-specific procedures for cleaning/disinfection and sterilization that are sufficiently validated, to regularly service and inspect the employed devices (disinfector, sterilizer), and to ensure that the validated and/or manufacturer's recommended parameters are maintained for each cycle. The statutory regulations applicable in the user's country and the hygiene requirements of the hospital/practice must also be observed. This applies in particular to the various instructions for effectively deactivating prions.

Basic Instructions If possible, use an automated procedure (disinfector) for cleaning and disinfecting. Do not use a manual procedure - even with an ultrasonic bath - due to the significantly reduced efficiency and potential damage. Pretreatment is required in both cases. Observe the following aspects when choosing detergents, disinfectants and equipment for all steps: • They must be suitable for their intended use (e.g. cleaning, disinfection or ultrasonic cleaning) • The detergents and disinfectants must be aldehyde-free (otherwise blood residues may dry and attach firmly to surfaces) • The disinfectant used must have a proven effectiveness (such as approval by VAH/DGHM or a CE mark) • The detergents and disinfectants must be suitable and compatible for use with the products • The manufacturer's instructions, such as those regarding exposure time, temperature and concentration, must be followed For cleaning, both for pre-cleaning and manual cleaning, observe the following: Use only clean, lint-free cloths (e.g. Perform classic from Schülke & Mayr) and/or soft brushes (e.g. Justman Brush, VWR International). Never use metal brushes or steel wool. For drying, Medartis recommends lint-free disposable wipes (e.g. Perform classic from Schülke & Mayr) or medical compressed air. For water quality, Medartis recommends that demineralized and purified water (e.g. Aqua purificata) is used for cleaning, disinfection and subsequent rinsing steps. Manual Cleaning and Disinfection Manual Cleaning • Place the products in the cleaning bath with enzymatic cleaning solution for 5 minutes (e.g. CIDEZYME® Enzymatic Detergent Solution, 1.6 % v/v). The products must be adequately covered and may not be covered by or be in touch with other products. Follow the enzymatic cleaner manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Clean with a soft plastic brush (e.g. Justman Brush, VWR International) • Clean the products in the ultrasonic bath for 15 minutes using a suitable detergent (e.g. CIDEZYME® Enzymatic Detergent Solution, 1.6 % v/v). Follow the detergent manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Rinse thoroughly using cold (T < 40°C) or warm (T > 40°C) water for at least one minute; hand-held water jets can also be used • Visually inspect the products and repeat the cleaning process as required until visible contamination is no longer evident • Inspect the products (see the section «Inspection») Manual Disinfection • Place the cleaned and inspected products in the disinfection bath for 15 minutes (e.g. CIDEX® OPA Solution). The products must be adequately covered and may not be covered by or in touch with other products. Follow the disinfection solution manufacturer’s instructions for use for correct exposure time, temperature and concentration. • Rinse with cold (T < 40°C) or warm (T > 40°C) water for at least one minute; hand-held water jets can also be used • Visually inspect the products and repeat the cleaning and disinfection process as required until visible contamination is no longer evident • The products must be completely dried directly afterwards (it is recommendable to dry them using medical compressed air) • Inspect the products (see the section, «Inspection»). • Pack the products preferably immediately or if necessary after giving them additional time to dry Automated Cleaning and Disinfection The above recommendations must also be followed when choosing detergents and disinfectants for this process. For automated cleaning, ensure that the products have been rinsed thoroughly and that there is no remaining foam. When selecting the disinfector, make sure that the cleaning process includes the following phases in accordance with EN ISO 15883: Phase

Temperature

Duration

Action

Cleaning

55°C (± 2°C) 131°F (± 3.6°F)*

10 min.*

Adding detergent*

Neutralization

Cold (T < 40°C)

2 min.

Neutralize with cold water

Rinsing

Cold (T < 40°C)

1 min.

Rinse with cold water

Thermal disinfection (Ao value > 3’000)

≥ 90°C (194°F)

5 min.

With demineralized and purified water; do not add additional detergent

Rinsing

Device-specific/ Cold (T < 40°C)

1 min.

Rinse with demineralized and purified water

Dry

Device-specific**

Device-specific**

Drying process

* The information provided is based on the use of «Neodisher MediClean forte» by Dr. Weigert; validation was performed with a concentration of 0.2 % at 50°C; however, exposure times, temperatures and concentrations may vary if a different detergent is used; follow the applicable information provided by the manufacturer. ** Drying temperatures must be < 141°C. When loading the disinfector, use the loading layouts provided by the manufacturer; also follow the detailed information provided in «Instructions for Cleaning, Disinfection and Sterilization» at www.medartis.com. Inspection of the TTS Tooth Splint Before assigning the TTS Tooth Splints to the sterilization container, check them after cleaning and disinfection for damage and contaminants, and remove damaged and contaminated splints. Sterilization Only use the following sterilization methods. Other sterilization methods are not allowed. Steam Sterilization All NON-STERILE products can be sterilized in an autoclave (EN 13060 and EN 285). For both initial and subsequent sterilization, the following parameters were validated by Medartis in accordance with the requirements of the current sterilization standards, EN ISO 17665 and ANSI/AAMI ST79: Procedure

Fractionated Vacuum Method

Flow Method

Exposure time

≥ 4 min

≥ 15 min.

Temperature

132°C/134°C

132°C/134°C

Drying time

> 20 ─ 30 min.

> 20 ─ 30 min.

Medartis recommends that sterilization is performed in accordance with the above validated processes. If the user utilizes other processes (e.g. flash sterilization), these must be validated by the user. The ultimate responsibility for validation of sterilization techniques and equipment lies with the user. Outside the USA: the sterilization time can be extended to 18 minutes to meet the recommendations of the WHO and the Robert Koch Institut (RKI). Medartis products are designed for these sterilization cycles. Do not use hot-air sterilization, radiation sterilization, formaldehyde sterilization, ethylene oxide sterilization or substitute procedures for sterilizing thermolabile products such as plasma or peroxide sterilization for

Artikelnummer / Bestellnummer Article number / Order number Référence / Numéro de commande Codice articolo / Numero d'ordine Lot number Lot-Nummer Numéro de lot Numero di lotto Non-sterile Unsteril Non stérile Non sterile Do not reuse Nicht wiederverwenden Ne pas réutiliser Non riutilizzare

Marking for Risk Class I medical devices, sterile, I with measuring function, IIA and IIB Kennzeichnung für Medizinprodukte der Risikoklasse I steril, I mit Messfunktion, IIA und IIB Sigle apposé sur les produits médicaux de la catégorie de risque I stérile, I avec fonction de mesure, IIA et IIB Marchio per i dispositivi medici della classe di rischio I sterili, I con funzione di misura, IIA e IIB Mark identifying medical devices of risk class I, non-sterile and with no measuring function. Kennzeichnung für Medizinprodukte der Risikoklasse I unsteril und ohne Messfunktion. Sigle apposé sur les produits médicaux pour indiquer leur catégorie de risque I non stérile et sans fonction de mesure. Marchio per i dispositivi medici della classe di rischio I non sterili e senza funzione di misura.