MODUS 2 Plates, Screws and Instruments Instructions for Use

Correct: LOCKED

Incorrect: UNLOCKED

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Instructions for Selecting the Appropriate MODUS 2 Products Medartis, as manufacturer, does not recommend a specific surgical procedure for a specific patient. The operating surgeon is solely responsible for choosing the appropriate implant for the specific case. The follow-up treatment as well as the decision of whether to retain or explant the implant is the responsibility of the user. The treating physician should beforehand become thoroughly familiarized with the procedure, for example by: • • • •

Carefully studying all the product documentation. Carefully reviewing the current professional literature. Consulting with colleagues experienced in this field and with the use of this system. Practice in handling the system, practice of the surgical procedure and postoperative treatment.

Generally, implants are designed to remain in the body temporarily and be removed after sufficient (osseous) healing has taken place. They are not designed for long term bone replacement. Where they are mechanically supporting the osteosynthesis, the regular operating period of the implants is expected to be between 30 days and 6 months. In consideration of the individual fracture situation as well as the compliance of the patient, the surgeon shall ensure an adequate postoperative relief of the osteosynthesis in terms of adaption- or mobilization stability (e.g. splinting and/or immobilization). Postoperatively, the fixation achieved by the implants must be treated carefully until osseous healing is completed. The doctor’s aftercare instructions have to be strictly observed by the patient in order to avoid adverse loads of the implants. Early load bearing can increase the risk of loosening, migration or breakage of the devices. In the case of complications, it might be necessary to remove the implants. For removal use the indicated screwdriver. Make sure that the screwdriver/screw head connection is precisely aligned in axial direction.

Additional Information Additional information on the products (e.g. the surgical technique, e, handling instructions for sterile plates, screws and instruments, care, cleaning, disinfection and sterilization of non sterile products) can be requested from your local Medartis Territory Consultant or distribution partner. In addition, all relevant information can be found on the internet at www.medartis.com.

Single-Use Device

mission of infectious material from one patient to another. This could result in injury of the patient or user. Implants that have not come into direct contact with a patient may be reprocessed. Implants that have come into direct contact with blood or other bodily fluids or show visual contamination must be cleaned and disinfected separately before they can be placed back into the implant module. It is your responsibility to ensure that the implants and instruments 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 your country and the hospital's hygiene requirements 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. Choosing Detergents, Disinfectants and Equipment 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 manufacturers' instructions, such as those regarding concentration, exposure time and temperature, must be followed. For cleaning materials and accessories, both for precleaning and manual cleaning, observe the following: • Use only clean, lint-free cloths (e.g. Peform classic from Schülke & Mayr) and/or soft brushes (e.g. Justman Brush from VWR International). Never use metal brushes or steel wool. • When necessary, use materials and accessories such as cleaning stylets, syringes, cannulas and bottle brushes for cannulated products or products with a lumen. For drying accessories, 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. Medartis instrument cases are intended for the sterilization, transportation and storage of products. They are not intended for cleaning and disinfection when loaded. The products must be removed from the cases and then cleaned and disinfected separately. Implant cases made of steel can undergo automated cleaning and disinfection when loaded. For manual cleaning, the implants must be removed from the system and then cleaned and disinfected separately.

The product is intended for one single application in a single patient. Application of an already used device may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury.

Sterile Packaged Products

Remove major contaminants in the operating room before segregating dirty instruments. Preferably use dry preparation for the transportation to the cleaning/sterilization department. If a wet preparation method is used, place the instruments in a prepared solution directly after usage. The instruments must be disassembled and opened as much as possible. All products (including grooves, holes, lumens, etc.) must be sufficiently covered with solution. To avoid damage to the materials, do not leave them in the solution for longer than directed. Pretreatment Prior to Cleaning, Disinfection and Sterilization

The product has been subjected to a validated irradiation sterilization process and is supplied in sterile packaging. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use any product where the sterile packaging has been opened or damaged and do not remove them from the packaging until immediately before use. Once the sterile packaging has been opened, the product cannot be resterilized. Sterility of the device must be ensured at all times. The device is for single-use only and may not be reused under any circumstances. Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury. Sterile packaged twist drills: Single-use, sterile packaged cutting tools such as twist drills are intended for single-use and must not be reused. Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury. All single-use cutting tools have to be discarded after the operation following the local requirements.

Non-Sterile Products

Instructions Regarding Cleaning, Disinfection and Sterilization of Non-Sterile Products All implants, instruments and containers in the APTUS systems that are delivered NONSTERILE must be cleaned, disinfected and sterilized before each use. This also applies to the first use after delivery (after removal of the protective transport packaging). Thorough cleaning and disinfection are essential for effective sterilization. All implant components are intended for one single application in a single patient. Implants that were used in a patient and removed, have to be discarded following the local requirements. Application of an already used device may compromise the structural integrity of the implants and/or lead to device failure which may result in patient injury. Furthermore, application of an implant that has already been used may create a risk of contamination e.g. due to the trans-

Pretreatment process • Disassemble and open the instruments as far as possible. When doing so, follow the assembly and disassembly instructions, which can be found at www.medartis.com. • Empty the instrument cases completely and remove the lid, if necessary. • For implant cases, the implants can be left in the case. • Clean products and individual parts under running water using soft brushes (shift moveable parts back and forth, use cleaning wire, syringes and cannulas for cannulated products; for larger lumina, use a bottle brush if necessary). • Visually inspect the products and repeat pretreatment as required until visible contamination is no longer evident. The disassembled instruments and cases should remain dismantled for the following cleaning and disinfection process. Manual Cleaning and Disinfection Manual Cleaning Process • Place the (disassembled) 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 the individual components should not be in a position to damage each other. 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 from VWR International). • Shift moveable parts back and forth several times. • Clean large lumina with a bottle brush. • Cannulated products (with cavities whose diameter is less than or equal to 1/6 of the device‘s length), must be cleaned by inserting the dedicated cleaning stylet and rinsed using a suitable cannula and disposable syringe (rinse volume: 30 ml). • 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 enzymatic detergent 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 (lumina and cannulated products must also be rinsed inside using syringes and suitable cannulas); 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»).

MODUS 2-00000101_Rev. C.2020/03/09 Instructions for Use for Medartis MODUS Plates, Screws and Instruments Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG/Medartis Holding AG, 4057 Basel/Switzerland

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Manual Disinfection Process • Place the (disassembled), cleaned and inspected products in the disinfection bath for 15 minutes (the products must be adequately covered and the individual components should not be in a position to damage each other). • Shift moveable parts back and forth several times. • Large lumina must also be filled on the inside. • Cannulated products (with cavities whose diameter is less than or equal to 1/6 of the device‘s length), e.g. cannulated drills, must be filled with disinfectant and rinsed using a syringe and suitable cannula (rinse volume: 30 ml). • Rinse with water for at least one minute (lumina and cannulated products must also be rinsed inside using syringes and suitable cannulas); 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») and service them (see the section «Product Care»). • Pack the products preferably immediately or if necessary after giving them additional time to dry. Automated Cleaning and Disinfection For automated cleaning and disinfection instruments have to be removed from the cases. Instruments have to be opened and disassembled! Implant cases can undergo automated cleaning and disinfection when loaded. Make sure the implant cases have been properly sealed with their lid prior to automated cleaning/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/104°)F

2 min.

Neutralize with cold water

Rinsing

Cold (T < 40°C/104°F)

1 min.

Rinse with cold water

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 Medartis products. After sterilization, the products must be stored in a dry and dust-free environment. Reusability (Implants and Instruments) All implant components are intended for one single application in a single patient. Implants that were used in a patient and removed, have to be discarded following the local requirements. Application of an already used device may compromise the structural integrity of the implants and/or lead to device failure which may result in patient injury. Furthermore, application of an implant that has already been used may create a risk of 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. Implants that have not come into direct contact with a patient may be reprocessed. Implants that have come into direct contact with blood or other bodily fluids or show visual contamination must be cleaned and disinfected separately before they can be placed back into the corresponding implant module. The instruments can be reused if corresponding precautions are observed and if they are undamaged and uncontaminated. No liability is assumed by the manufacturer in case of non-observance. Medartis recommends: if products come in contact with pathogens that are difficult to identify such as variations of Creutzfeldt-Jakob’s disease (confirmed or suspected pathogen), they must be discarded. Manufacturer Medartis AG Hochbergerstrasse 60E 4057 Basel/Switzerland

Consult instructions for use

Thermal disinfection (Ao value > 3’000)

≥ 90°C (194°F)

5 min.

With demineralized and purified water; do not add additional detergent

Dry

Device-specific**

Device-specific

Drying process

Article number / Order number

Lot number

* The information provided is based on the use of «Neodisher MediClean forte» by Dr. Weigert; validation has been performed with a concentration of 0.2 % at 50°C; however, exposure times, temperatures and concentrations, times and temperatures may vary if a different detergent is used; follow the applicable information provided by the manufacturer.

Non-sterile

** Drying temperature 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 (Implants and Instruments) Check implants and instruments after cleaning and disinfection for damage and contaminants, and remove damaged and contaminated implants. After the instruments are cleaned and disinfected, check them all for damage (e.g. corrosion, damage to surfaces, chipping, etc.), contaminants and function. Remove damaged instruments. In addition, instruments with lumina have to be checked for free passage without obstructions, cutting instruments must be checked for sharpness and rotating instruments must be checked for bending. Instruments that are still soiled must be cleaned and disinfected again. You can find further details at www.medartis.com in «Instructions for Cleaning, Disinfection and Sterilization». Product Care Carefully apply maintenance products (paraffin-based/white oil-based, biocompatible, steamsterilizable and steam-permeable) to the articulations, closures or threads and sliding surfaces. Do not use maintenance products containing silicone. The disassembled instruments and cases should be reassembled for the following sterilization process.

Do not reuse

Do not resterilize

Do not use if package is damaged

Sterilized using irradiation

Use by date

Sterilization Medartis recommends sterilizing the products in the designated MODUS 2 implant containers and instrument cases. If the total weight of the loaded module is over 10 kg, the module must not be sterilized in a sterilization container; rather, wrap it in sterilization paper and sterilize it according to state of the art techniques and using approved methods. 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: Fractionated and Dynamic Prevacuum Process ≥ 4 min

Flow and Gravitation Processes ≥ 15 min.

Temperature

132°C/134°C

132°C/134°C

Drying time

> 20 ─ 30 min.

> 20 ─ 30 min.

Procedure Exposure time

Manufacturer

Date of manufacture

Marking for Risk Class I medical devices, sterile, I with measuring function, IIA and IIB

MODUS 2-00000101_Rev. C.2020/03/09 Instructions for Use for Medartis MODUS Plates, Screws and Instruments Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG/Medartis Holding AG, 4057 Basel/Switzerland

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Marking for Risk Class I medical devices, non-sterile and without measuring function

Conditionally MR safe

This document is subject to continuous revision. Please verify that the current printed version is identical to the one at www.medartis.com.

MODUS 2-00000101_Rev. C.2020/03/09 Instructions for Use for Medartis MODUS Plates, Screws and Instruments Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG/Medartis Holding AG, 4057 Basel/Switzerland

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