Anatomic Radial Head Systems Instructions for Use

US

Instructions for use

U.S. English – US / PAGE 3

Caution: • •

• • • • • • •

The implants and instruments are intended only for professional use by a licensed physician. Do not use or re-sterilize an implant provided in sterile packaging if the package has been damaged. The sterility may be compromised and the cleanliness of the implant may be uncertain. Report damaged packaging to your distributor or Acumed. Mixing implant components from different manufacturers is not recommended for metallurgical, mechanical and functional reasons. Do not use the sterile product past the use-by date. Refer to the device label. Do not reuse single use surgical instruments. The instrument may suddenly fail as a result of previous stresses. Do not resharpen drill bits or reamers as these devices have critical dimensions and geometries that cannot be restored once the instrument has been consumed. Do not use chemical disinfection methods as chemical residues may affect steam sterilization. Do not block holes in the case or trays, for example with labels, as this may adversely affect steam penetration and sterilization. Screws, tacks, Kirschner wires, guidewires, cutting instruments, and similar devices may be sharp. Observe hospital procedures, practice guidelines, and/or government regulations for the proper handling and disposal of sharps.

ADVERSE EFFECTS Possible adverse effects include: • Pain, discomfort, or abnormal sensations, nerve or soft tissue damage, necrosis of bone or tissue, bone resorption, or inadequate healing from the presence of an implant or due to surgical trauma. • Implant fracture due to excessive activity, prolonged loading upon the device, incomplete healing, or excessive force exerted on the implant during insertion. Implant migration and/or loosening may occur. • Metal sensitivity, histological, allergic or adverse foreign body reaction resulting from implantation of a foreign material. Consult our document “Metal Sensitivity Statement” at www.acumed.net/ifu. SURGICAL TECHNIQUE Acumed offers one or more Surgical Techniques to promote the safe and effective use of this system. Consult our Surgical Techniques at www.acumed.net. Important: Surgical techniques may contain important safety information.

Important: The instruments and implants in this system are intended to be used by suitably trained and qualified surgeons in a hospital operating room setting. Before treatment, the surgeon is advised to read and fully understand all instructions and communicate to the patient any relevant medical information provided therein, including the use, limitations, risks (safety communications), and possible adverse effects of the proposed treatment. Consult the most recent versions of the Instructions for Use and Surgical Techniques as they are subject to change. Contact Acumed or an authorized agent to request any additional information.

US

Instructions for use

U.S. English – US / PAGE 4

MRI SAFETY INFORMATION Many Acumed implants have been evaluated for safety in the MR environment. Consult our publication “Acumed Implants in the MR Environment” at www.acumed.net/ifu for more information. LIFETIME • The prosthesis has been tested at standardized conditions to establish a minimum service life of 1 million cycles, which may be shorter than the life of the patient. Actual use conditions may affect the service life of the prosthesis. • Multiple-use instruments have a lifetime that is affected by usage, handling, and processing. Assess multiple-use instruments for fitness during the pre-sterilization inspection. • Sterile parts may be implanted up to the date of expiration indicated on the label. STERILITY • Implants and instruments may be provided either sterile or non-sterile as indicated on the label. • Non-sterile devices are intended to be sterilized before use. • Devices purchased and received sterile were exposed to a minimum dose of 25.0 kGy gamma radiation to obtain a minimum sterility assurance level of 10-6.

IMPLANTS MATERIALS • The radial head implant is manufactured from wrought cobalt-28chromium-6molybdenum alloy (UNS R31537) per ASTM F1537. • The stem implant is manufactured from wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (UNS R56401) per ASTM F136. • Consult our document “Metal Sensitivity Statement” at www.acumed.net/ifu for the chemical composition of Acumed metal implants. SINGLE USE • Implants are intended for single use only, as indicated on the label. • Do not reuse single use implants as this may increase the risks of failure and cross-contamination. • Dispose of any unused implant that is contaminated with human blood or tissue. Do not process a contaminated implant. IMPORTANT • For safe and effective use, the surgeon must be thoroughly familiar with the implant, the methods of application, instruments, and the recommended surgical technique. • Physiological dimensions limit implant sizes. Select the type and size of implant that best meets the patient’s requirements for close adaptation and firm seating with adequate support. • Implants are not designed to withstand the stresses of full weight or load bearing, or excessive activity.

US

Instructions for use

U.S. English – US / PAGE 5

• Improper selection or improper implantation of the device may increase the possibility of loosening or migration. • Only combine implants when they are intended for that purpose. • Protect implants against scratching and nicking to prevent stress concentrations, which can result in failure. • Prevent unused implants from becoming soiled. • The color of anodized implants may change over time due to processing. This color change does not affect the mechanical properties of the implants.

INSTRUMENTS MATERIALS The instruments are manufactured from various grades of titanium, stainless steel, aluminum, silicone, Radel, and Ultem. MULTIPLE USE and SINGLE USE • Instruments are intended for multiple use unless identified on the label for single use only. • Single use instruments are intended to be disposed after use on a single patient during a single procedure. • Do not reuse single use instruments as this may increase the risks of failure and cross-contamination. • Multiple use instruments are only intended for use on a single patient and a single procedure before requiring processing. • Multiple (limited) use instruments have a limited lifespan. Immediately replace any multiple use instrument if performance becomes inadequate. • Multiple use instruments potentially contaminated with transmissible spongiform encephalopathy (TSE) agents shall not be processed for reuse. IMPORTANT • Protect instruments against scratching and nicking to prevent stress concentrations, which can lead to instrument failure. • Near the point of use: Wipe excess contamination from instruments and prevent any soil from drying. Instruments with substantial or dried soil are particularly difficult to reliably process. Transport contaminated instruments for processing as soon as possible after use. • Avoid prolonged instrument contact with iodine and saline. • Handle and transport soiled instruments in a manner that avoids contamination of any unused implants.

PROCESSING

Important: Processing personnel must be qualified with suitable training and experience. Use proper personal protective equipment (PPE) when working with contaminated devices.

US

Instructions for use

U.S. English – US / PAGE 6

IMPORTANT • Promptly perform the processing steps to limit microbial growth and maximize the effectiveness of sterilization. • Inspect implants for contamination by blood or tissue and dispose of them when found. Do not process contaminated implants. • Prevent instrument corrosion by minimizing contact with solutions containing iodine, chlorine, and saline or other metal salts. • Prevent damage to the protective anodization layer on aluminum instruments by avoiding contact with solutions < 4 pH and > 9 pH, especially if they contain sodium carbonate or sodium hydroxide. • Repeated processing of anodized metals may cause colors to fade but this does not affect the function of the device. • Avoid cleaning agents containing aldehydes since they can denature and coagulate proteins (fixation). • Enzymatic detergents are well suited for loosening protein-based contamination. - Use a neutral pH enzymatic detergent. - Use a low foaming solution to allow visibility of the device during cleaning. • Closely follow the manufacturer’s instructions for the safety, storage, mixing, water quality, exposure time, temperature, replacement, and disposal of cleaning agents. • Devices potentially contaminated with transmissible spongiform encephalopathy (TSE) agents shall not be processed or reused. These processing instructions are not suitable for inactivation of TSE agents. Observe hospital procedures, practice guidelines, and/or government regulations for the proper handling and disposal of devices potentially contaminated with TSE agents. • Utility water: Refer to AAMI TIR34* when instructed to use utility water. Utility water is typically municipal or tap water but may require additional treatment to be suitable for use. • Critical water: Refer to AAMI TIR34* when instructed to use critical water. Critical water is highly treated and has very low organic and inorganic content with an endotoxin level under 10 EU/mL. Suitable water may also be specified in national pharmacopeias, national standards, and hospital protocols. * Association for the Advancement of Medical Instrumentation (AAMI). Water for the reprocessing of medical devices. AAMI TIR34:2014/(R)2017. Arlington, VA. MANUAL CLEANING 1. 2. 3. 4. 5. 6. 7.

Rinse the contaminated instruments under running cold utility water to reduce heavy surface contamination. Dispose of any used instruments intended for single use only. Place the contaminated instruments in enzymatic solution* until completely submerged to minimize the spraying of solution. Actuate all moveable parts to allow detergent to contact all surfaces. Soak for a minimum of ten (10) minutes. Scrub the instruments using a soft-bristled brush to remove all visible debris. Do not use stainless steel or other abrasives as these may damage the surface. - When possible, scrub the instruments when totally submerged to minimize the spraying of fluid. Some instruments may require special consideration: - Clean the instruments with all parts loosened. Clean the instruments disassembled if they are designed to be taken apart. - Use a water jet to flood cleaning solution into challenging areas, such as mating surfaces, springs, coils, cannulations, blind holes, flutes, cutting teeth, and flexible parts to flush out any trapped soil.

US

Instructions for use -

U.S. English – US / PAGE 7

Operate movable parts and rotate (as necessary) while scrubbing to ensure that all crevices are accessible. Carefully clean cannulated parts and challenging areas using an appropriately sized brush. Optionally sonicate for 10 to 15 minutes using a fresh, neutral pH ultrasonic cleaning solution. Follow the ultrasonic cleaner and detergent manufacturer’s instructions. Important: Any previous surface damage may increase due to ultrasonic cleaning.

8. Perform an initial rinse for at least 3 minutes using clean, soft, utility water in the temperature range of 25°C to 35°C (77°F to 95°F) to remove all signs of contamination and cleaning agent. - Actuate all movable parts. - Flush out cannulations and complex mechanisms. 9. Repeat the previous processing steps if visible residue remains present. 10. Perform a final rinse for at least 1 minute using critical water to displace minerals and other impurities found in utility water. Do not use saline solutions for final rinsing because they may interfere with disinfection and sterilization. - Actuate all moving parts - Pay particular attention to cannulations and blind holes as well as hinges and joints between mating surfaces. - Rinse cannulations at least three times with a syringe (volume 1-50ml). 11. Remove excess moisture from the instruments using a clean, absorbent, non-shedding wipe. 12. Allow the instruments to thoroughly dry. Any moisture may affect sterilization and devices may remain wet after the drying period. * Manual cleaning was validated using STERIS Prolystica 2X Concentrate Enzymatic Presoak and Cleaner. WASHER - DISINFECTOR: AUTOMATED CLEANING - THERMAL DISINFECTION Important: Automated cleaning requires manual cleaning. Always perform the previous manual cleaning steps first. Follow the washer-disinfector manufacturer’s instructions explicitly. • Process the devices using a standard washing and thermal disinfection cycle in a washer-disinfector compliant with EN ISO 15883-1 and EN ISO 15883-2 or equivalent national standards. • Remove all implants if a lubrication phase will be used. • Process all trays removed from the case • Attach the following instruments to the minimally invasive surgery (MIS) injector or irrigation ports: - 80-0663 Medium Ratcheting Driver Handle - MS-3200 Large Cannulated Quick Release Driver Handle • Thermal disinfection has been validated* for an A 0 ≥ 3000 (at least 5 minutes at 90°C). * Washer-disinfector processing was validated for fully loaded trays with all parts placed appropriately, with recommended evaluations as listed in EN ISO 15883-1 and EN ISO 15883-2 using a STERIS Reliance® Genfore Washer-Disinfector and STERIS Prolystica 2X Enzymatic Detergent. PRE-STERILIZATION INSPECTION • Visually inspect all devices under normal lighting to ensure that cleaning was effective. Pay close attention to all challenging areas. - Re-process an instrument that is not clean. - Replace an instrument that cannot be cleaned. • Inspect the implants and instruments for surface damage, such as nicks, scratches, and cracks. Replace any device that is affected.

US

Instructions for use

U.S. English – US / PAGE 8

• Assess the instruments for proper use. Operate all parts and connecting mechanisms. Give careful attention to drivers, drill bits and reamers, and instruments used for cutting or implant insertion. Critically assess them for wear, sharpness, straightness, and corrosion. Replace any instrument that does not perform as intended. • Inspect all cutting edges under magnification. - Replace an instrument if a cutting edge is dull, chipped, cracked, rolled, or otherwise deformed. - Running a cotton cloth over the edge may help detect chipping and cracking. • Verify the legibility of all markings and reference scales. Replace any device that is unreadable. • Repair, replace, and/or repeat the cleaning of instruments as needed to ensure proper operation before proceeding with sterilization. • Lubrication (“instrument milk”) may increase the useful life of surgical instruments. Do not use siliconebased lubricants, oil, or grease, as these will interfere with steam sterilization. Only use a water-based lubricant intended for use on surgical instruments and with steam sterilization. Use the lubricant as directed by the manufacturer. Use critical water if dilution is required. • Fully replenish the system trays and caddies. STERILIZATION • Perform sterilization using a dynamic-air-removal (prevacuum) autoclave. - Gravity displacement sterilization is not recommended. - Immediate use (flash) sterilization is not recommended. • Ensure the sterilizer’s maximum load limit is not exceeded when sterilizing multiple sets or devices. • Do not stack containers as this might prevent the penetration of steam and inhibit drying. • Refer to the sterilizer manufacturer's instructions and ensure proper installation, calibration, use, and ongoing maintenance. • The sterilized items should be allowed to cool to room temperature before handling. This allows for safe handling and preventing condensation. • Follow current industry best practice guidelines such as ANSI/AAMI ST79:2017*. * Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility assurance in health care facilities. AAMI ST79:2017. Arlington, VA. • The following table shows the minimum parameters validated* to achieve a required Sterility Assurance Level (SAL) of 10-6 for the system. Important: -

Sterilization parameters are only valid for devices that have been cleaned per these instructions and are thoroughly dry. Sterilization parameters are only valid when the devices are properly housed in the Acumed storage case part numbers identified in the table.

US

Instructions for use

U.S. English – US / PAGE 9

Anatomic Radial Head System: Prevacuum Steam Sterilizer Parameters Storage Case Part Numbers:

Base: TR-0003 Case Lid: TR-0002

Condition1:

Wrapped

Exposure Temperature:

270°F (132°C)

Exposure Time:

25 minutes

Dry Time:

50 minutes

Anatomic Radial Head Broaches (TR-BRA06, TR-BRA07, TR-BRA08, TR-BRA09, TR-BRA10) Prevacuum Steam Sterilizer Parameters Storage Case Part Numbers:

Aesculap Basket

Condition1:

Wrapped

Exposure Temperature and Time:

270°F (132°C) 4 minutes

Exposure Temperature and Time2:

273°F (134°C) 3 minutes

Dry Time:

30 minutes

Anatomic Radial Head Solutions, Anatomic Radial Head Solutions 2: Prevacuum Steam Sterilizer Parameters ARH Solutions Storage Case Part Numbers:

Base: 80-2000 Case Lid: 80-2001

ARH Solutions 2 Storage Case Part Numbers:

Base: 80-3640, 80-3692, 80-3693, 80-4040, 80-4041, 80-4042, 80-4043 Case Lid: 80-3641, 80-4068

Condition1:

Wrapped

Exposure Temperature and Time:

270°F (132°C) 4 minutes

Exposure Temperature and Time2:

273°F (134°C) 3 minutes

Dry Time:

30 minutes

1 US customers must use FDA-cleared sterilization packaging/wrap and other accessories appropriate for the cycle

parameters recommended in these instructions. Refer to PKGI-76 at www.acumed.net/ifu for sterilization in Aesculap® rigid sterilization containers. 2 The devices are compatible with exposure for 18 minutes at 134°C.

US

Instructions for use

U.S. English – US / PAGE 10

* Sterilization was validated using a STERIS Amsco 3023 Vacamatic Prevacuum sterilizer and KimGuard KC600 One-Step wrap. POST-STERILIZATION INSPECTION • Do not store or use sterile devices if they are not dry. - Moisture supports the survival of microorganisms. - Moisture remaining on wrapped or contained products after sterilization could compromise the sterile barrier. - Moisture can corrode metal and dull sharp edges. • Inspect the sterile barrier for signs of damage. Do not use the product if the sterile barrier has been compromised.

STORAGE CONDITIONS STORAGE OF PACKAGED PRODUCT •

Items should be stored under controlled conditions in a manner that minimizes the potential for contamination per ANSI/AAMI ST79:2017. Refer to sterilization wrap or rigid container manufacturer's IFU for limits on sterile product storage time and storage requirements for temperature and humidity.

STORAGE OF STERILE PRODUCT •

Sterile product should be stored at room temperature (59-77 oF or 15-25oC) and protected from direct sunlight, pests, and high humidity.

US

Instructions for use

U.S. English – US / PAGE 11

Symbols Glossary

Symbol

Rx Only

Description

ISO 15223-1

Consult the electronic instructions for use (eIFU) at www.acumed.net/ifu

5.4.3

Caution

5.4.4

Sterilized using irradiation

5.2.4

Double sterile barrier system

5.2.12

Non-sterile

5.2.7

Use-by date

5.1.4

Catalogue number

5.1.6

Batch code

5.1.5

Authorized representative in the European Community / European Union

5.1.2

Medical device

5.7.7

Manufacturer

5.1.1

Date of manufacture

5.1.3

Do not resterilize

5.2.6

Do not re-use

5.4.2

Do not use if package is damaged and consult instructions for use / do not use if the product sterile barrier system or its packaging is compromised

5.2.8

Caution: U.S. federal law restricts this device to sale by or on the order of a physician.

U.S. 21 CFR 801.109

The reticle is a registered trademark of Acumed. It may appear alone or with the Acumed name. CE marking of conformity, Article 17 of EU Directive 93/42/EEC. CE marking may be accompanied by the identification number of the notified body responsible for conformity assessment.

EN

English (non-U.S.) – EN / PAGE 47

Instructions for use Anatomic Radial Head System, Anatomic Radial Head Solutions, Anatomic Radial Head Solutions 2 EN

These instructions are intended for the Operating Surgeon and supporting Healthcare Professionals. The EN instructions are intended for users in English speaking countries outside the United States and its territories.

DESCRIPTION Acumed Anatomic Radial Head implants and instruments are designed to replace the articular surface of the radial head. INDICATIONS FOR USE The Acumed Anatomic Radial Head System, Anatomic Radial Head Solutions, and Anatomic Radial Head Solutions 2 and accessories are designed specifically for (1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment, (2) Primary replacement after fracture of the radial head, (3) Symptomatic sequelae after radial head resection, (4) Revision following failed radial head arthroplasty. The implant is intended to be press fit or cemented. CONTRAINDICATIONS • • • • •

Active or latent infection Sepsis Insufficient quantity or quality of bone, osteoporosis Soft tissue or material sensitivity Patients who are unwilling or incapable of following post-operative care instructions

WARNINGS & PRECAUTIONS Warning: • The treatment or implant may fail, including sudden failure, as a result of: - Loose fixation and/or loosening - Stress, include stress from inappropriate bending of the implant during surgery - Stress concentrations - Stress of weight bearing, load bearing, or excessive activity • Failure is more likely if the implant experiences increased loads due to delayed union, nonunion, or incomplete healing. Failure is more likely if the patient does not follow post-operative care instructions. • Nerve or soft tissue damage may result from surgical trauma or the presence of an implant. • Instrument breakage or damage, as well as tissue damage, may occur when an instrument is subjected to excessive loads, excessive speeds, dense bone, improper use or unintended use. • Implants may cause distortion and/or block the view of anatomic structures on radiographic images.

EN

Instructions for use

English (non-U.S.) – EN / PAGE 48

Caution: • The implants and instruments are intended only for professional use by a licensed physician. • Do not use or re-sterilize an implant provided in sterile packaging if the package has been damaged. The sterility may be compromised and the cleanliness of the implant may be uncertain. Report damaged packaging to your distributor or Acumed. • Mixing implant components from different manufacturers is not recommended for metallurgical, mechanical and functional reasons. • Do not use the sterile product past the use-by date. Refer to the device label. • Do not reuse single use surgical instruments. The instrument may suddenly fail as a result of previous stresses. • Do not resharpen drill bits or reamers as these devices have critical dimensions and geometries that cannot be restored once the instrument has been consumed. • Do not use chemical disinfection methods as chemical residues may affect steam sterilization. • Do not block holes in the case or trays, for example with labels, as this may adversely affect steam penetration and sterilization. • Screws, tacks, Kirschner wires, guidewires, cutting instruments, and similar devices may be sharp. Observe hospital procedures, practice guidelines, and/or government regulations for the proper handling and disposal of sharps. ADVERSE EFFECTS Possible adverse effects include: • Pain, discomfort, or abnormal sensations, nerve or soft tissue damage, necrosis of bone or tissue, bone resorption, or inadequate healing from the presence of an implant or due to surgical trauma. • Implant fracture due to excessive activity, prolonged loading upon the device, incomplete healing, or excessive force exerted on the implant during insertion. Implant migration and/or loosening may occur. • Metal sensitivity, histological, allergic or adverse foreign body reaction resulting from implantation of a foreign material. Consult our document “Metal Sensitivity Statement” at www.acumed.net/ifu. SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) The SSCP for the implants may be obtained from the European dataset on medical devices (Eudamed) at https://ec.europa.eu/tools/eudamed. Use the following search term: 0806378BUDI1S6. Note: Any serious incident that has occurred in relation to the device should be reported to Acumed and the competent authority of the Member State in which the user and/or patient is established. SURGICAL TECHNIQUE Acumed offers one or more Surgical Techniques to promote the safe and effective use of this system. Consult our Surgical Techniques at www.acumed.net. Important: Surgical techniques may contain important safety information.

EN

Instructions for use

English (non-U.S.) – EN / PAGE 49

Important: The instruments and implants in this system are intended to be used by suitably trained and qualified surgeons in a hospital operating room setting. Before treatment, the surgeon is advised to read and fully understand all instructions and communicate to the patient any relevant medical information provided therein, including the use, limitations, risks (safety communications), and possible adverse effects of the proposed treatment. Consult the most recent versions of the Instructions for Use and Surgical Techniques as they are subject to change. Contact Acumed or an authorized agent to request any additional information. MRI SAFETY INFORMATION Many Acumed implants have been evaluated for safety in the MR environment. Consult our publication “Acumed Implants in the MR Environment” at www.acumed.net/ifu for more information. LIFETIME • The prosthesis has been tested at standardized conditions to establish a minimum service life of 1 million cycles, which may be shorter than the life of the patient. Actual use conditions may affect the service life of the prosthesis. • Multiple-use instruments have a lifetime that is affected by usage, handling, and processing. Assess multiple-use instruments for fitness during the pre-sterilization inspection. • Sterile parts may be implanted up to the date of expiration indicated on the label. STERILITY • Implants and instruments may be provided either sterile or non-sterile as indicated on the label. • Non-sterile devices are intended to be sterilized before use. • Devices purchased and received sterile were exposed to a minimum dose of 25.0 kGy gamma radiation to obtain a minimum sterility assurance level of 10-6.

IMPLANTS MATERIALS • The radial head implant is manufactured from wrought cobalt-28chromium-6molybdenum alloy (UNS R31537) per ASTM F1537. • The stem implant is manufactured from wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (UNS R56401) per ASTM F136. • Consult our document “Metal Sensitivity Statement” at www.acumed.net/ifu for the chemical composition of Acumed metal implants. SINGLE USE • Implants are intended for single use only, as indicated on the label. • Do not reuse single use implants as this may increase the risks of failure and cross-contamination.

EN

Instructions for use

English (non-U.S.) – EN / PAGE 50

• Dispose of any unused implant that is contaminated with human blood or tissue. Do not process a contaminated implant. IMPORTANT • For safe and effective use, the surgeon must be thoroughly familiar with the implant, the methods of application, instruments, and the recommended surgical technique. • Physiological dimensions limit implant sizes. Select the type and size of implant that best meets the patient’s requirements for close adaptation and firm seating with adequate support. • Implants are not designed to withstand the stresses of full weight or load bearing, or excessive activity. • Improper selection or improper implantation of the device may increase the possibility of loosening or migration. • Only combine implants when they are intended for that purpose. • Protect implants against scratching and nicking to prevent stress concentrations, which can result in failure. • Prevent unused implants from becoming soiled. • The color of anodized implants may change over time due to processing. This color change does not affect the mechanical properties of the implants.

INSTRUMENTS MATERIALS The instruments are manufactured from various grades of titanium, stainless steel, aluminum, silicone, Radel, and Ultem. MULTIPLE USE and SINGLE USE • Instruments are intended for multiple use unless identified on the label for single use only. • Single use instruments are intended to be disposed after use on a single patient during a single procedure. • Do not reuse single use instruments as this may increase the risks of failure and cross-contamination. • Multiple use instruments are only intended for use on a single patient and a single procedure before requiring processing. • Multiple (limited) use instruments, have a limited lifespan. Immediately replace any multiple use instrument if performance becomes inadequate. • Multiple use instruments potentially contaminated with transmissible spongiform encephalopathy (TSE) agents shall not be processed for reuse. IMPORTANT • Protect instruments against scratching and nicking to prevent stress concentrations, which can lead to instrument failure. • Near the point of use: Wipe excess contamination from instruments and prevent any soil from drying. Instruments with substantial or dried soil are particularly difficult to reliably process. Transport contaminated instruments for processing as soon as possible after use. • Avoid prolonged instrument contact with iodine and saline.

EN

Instructions for use

English (non-U.S.) – EN / PAGE 51

• Handle and transport soiled instruments in a manner that avoids contamination of any unused implants.

PROCESSING

Important: Processing personnel must be qualified with suitable training and experience. Use proper personal protective equipment (PPE) when working with contaminated devices. IMPORTANT • Promptly perform the processing steps to limit microbial growth and maximize the effectiveness of sterilization. • Inspect implants for contamination by blood or tissue and dispose of them when found. Do not process contaminated implants. • Prevent instrument corrosion by minimizing contact with solutions containing iodine, chlorine, and saline or other metal salts. • Prevent damage to the protective anodization layer on aluminum instruments by avoiding contact with solutions < 4 pH and > 9 pH, especially if they contain sodium carbonate or sodium hydroxide. • Repeated processing of anodized metals may cause colors to fade but this does not affect the function of the device. • Avoid cleaning agents containing aldehydes since they can denature and coagulate proteins (fixation). • Enzymatic detergents are well suited for loosening protein-based contamination. - Use a neutral pH enzymatic detergent. - Use a low foaming solution to allow visibility of the device during cleaning. • Closely follow the manufacturer’s instructions for the safety, storage, mixing, water quality, exposure time, temperature, replacement, and disposal of cleaning agents. • Devices potentially contaminated with transmissible spongiform encephalopathy (TSE) agents shall not be processed or reused. These processing instructions are not suitable for inactivation of TSE agents. Observe hospital procedures, practice guidelines, and/or government regulations for the proper handling and disposal of devices potentially contaminated with TSE agents. • Utility water: Refer to AAMI TIR34* when instructed to use utility water. Utility water is typically municipal or tap water but may require additional treatment to be suitable for use. • Critical water: Refer to AAMI TIR34* when instructed to use critical water. Critical water is highly treated and has very low organic and inorganic content with an endotoxin level under 10 EU/mL. Suitable water may also be specified in national pharmacopeias, national standards, and hospital protocols. * Association for the Advancement of Medical Instrumentation (AAMI). Water for the reprocessing of medical devices. AAMI TIR34:2014/(R)2017. Arlington, VA. MANUAL CLEANING 1.

Rinse the contaminated instruments under running cold utility water to reduce heavy surface contamination. 2. Dispose of any used instruments intended for single use only. 3. Place the contaminated instruments in enzymatic solution* until completely submerged to minimize the spraying of solution. 4. Actuate all moveable parts to allow detergent to contact all surfaces.

EN

Instructions for use

English (non-U.S.) – EN / PAGE 52

5. Soak for a minimum of ten (10) minutes. 6. Scrub the instruments using a soft-bristled brush to remove all visible debris. Do not use stainless steel or other abrasives as these may damage the surface. - When possible, scrub the instruments when totally submerged to minimize the spraying of fluid. 7. Some instruments may require special consideration: - Clean the instruments with all parts loosened. Clean the instruments disassembled if they are designed to be taken apart. - Use a water jet to flood cleaning solution into challenging areas, such as mating surfaces, springs, coils, cannulations, blind holes, flutes, cutting teeth, and flexible parts to flush out any trapped soil. - Operate movable parts and rotate (as necessary) while scrubbing to ensure that all crevices are accessible. - Carefully clean cannulated parts and challenging areas using an appropriately sized brush. - Optionally sonicate for 10 to 15 minutes using a fresh, neutral pH ultrasonic cleaning solution. Follow the ultrasonic cleaner and detergent manufacturer’s instructions. Important: Any previous surface damage may increase due to ultrasonic cleaning. 8. Perform an initial rinse for at least 3 minutes using clean, soft, utility water in the temperature range of 25°C to 35°C (77°F to 95°F) to remove all signs of contamination and cleaning agent. - Actuate all movable parts. - Flush out cannulations and complex mechanisms. 9. Repeat the previous processing steps if visible residue remains present. 10. Perform a final rinse for at least 1 minute using critical water to displace minerals and other impurities found in utility water. Do not use saline solutions for final rinsing because they may interfere with disinfection and sterilization. - Actuate all moving parts - Pay particular attention to cannulations and blind holes as well as hinges and joints between mating surfaces. - Rinse cannulations at least three times with a syringe (volume 1-50ml). 11. Remove excess moisture from the instruments using a clean, absorbent, non-shedding wipe. 12. Allow the instruments to thoroughly dry. Any moisture may affect sterilization and devices may remain wet after the drying period. * Manual cleaning was validated using STERIS Prolystica 2X Concentrate Enzymatic Presoak and Cleaner. WASHER - DISINFECTOR: AUTOMATED CLEANING - THERMAL DISINFECTION Important: Automated cleaning requires manual cleaning. Always perform the previous manual cleaning steps first. Follow the washer-disinfector manufacturer’s instructions explicitly. • Process the devices using a standard washing and thermal disinfection cycle in a washer-disinfector compliant with EN ISO 15883-1 and EN ISO 15883-2 or equivalent national standards. • Remove all implants if a lubrication phase will be used. • Process all trays removed from the case. • Attach the following instruments to the minimally invasive surgery (MIS) injector or irrigation ports: - 80-0663 Medium Ratcheting Driver Handle - MS-3200 Large Cannulated Quick Release Driver Handle • Thermal disinfection has been validated* for an A 0 ≥ 3000 (at least 5 minutes at 90°C).

EN

Instructions for use

English (non-U.S.) – EN / PAGE 53

* Washer-disinfector processing was validated for fully loaded trays with all parts placed appropriately, with recommended evaluations as listed in EN ISO 15883-1 and EN ISO 15883-2 using a STERIS Reliance® Genfore Washer-Disinfector and STERIS Prolystica 2X Enzymatic Detergent.

PRE-STERILIZATION INSPECTION • Visually inspect all devices under normal lighting to ensure that cleaning was effective. Pay close attention to all challenging areas. - Re-process an instrument that is not clean. - Replace an instrument that cannot be cleaned. • Inspect the implants and instruments for surface damage, such as nicks, scratches, and cracks. Replace any device that is affected. • Assess the instruments for proper use. Operate all parts and connecting mechanisms. Give careful attention to drivers, drill bits and reamers, and instruments used for cutting or implant insertion. Critically assess them for wear, sharpness, straightness, and corrosion. Replace any instrument that does not perform as intended. • Inspect all cutting edges under magnification. - Replace an instrument if a cutting edge is dull, chipped, cracked, rolled, or otherwise deformed. - Running a cotton cloth over the edge may help detect chipping and cracking. • Verify the legibility of all markings and reference scales. Replace any device that is unreadable. • Repair, replace, and/or repeat the cleaning of instruments as needed to ensure proper operation before proceeding with sterilization. • Lubrication (“instrument milk”) may increase the useful life of surgical instruments. Do not use siliconebased lubricants, oil, or grease, as these will interfere with steam sterilization. Only use a water-based lubricant intended for use on surgical instruments and with steam sterilization. Use the lubricant as directed by the manufacturer. Use critical water if dilution is required. • Fully replenish the system trays and caddies. STERILIZATION • Perform sterilization using a dynamic-air-removal (prevacuum) autoclave. - Gravity displacement sterilization is not recommended. - Immediate use (flash) sterilization is not recommended. • Ensure the sterilizer’s maximum load limit is not exceeded when sterilizing multiple sets or devices. • Do not stack containers as this might prevent the penetration of steam and inhibit drying. • Refer to the sterilizer manufacturer's instructions and ensure proper installation, calibration, use, and ongoing maintenance. • The sterilized items should be allowed to cool to room temperature before handling. This allows for safe handling and preventing condensation. • Follow current industry best practice guidelines such as ANSI/AAMI ST79:2017*. * Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility assurance in health care facilities. AAMI ST79:2017. Arlington, VA. • The following table shows the minimum parameters validated* to achieve a required Sterility Assurance Level (SAL) of 10-6 for the system.

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Instructions for use

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Important: -

Sterilization parameters are only valid for devices that have been cleaned per these instructions and are thoroughly dry. Sterilization parameters are only valid when the devices are properly housed in the Acumed storage case part numbers identified in the table.

Anatomic Radial Head System: Prevacuum Steam Sterilizer Parameters Storage Case Part Numbers:

Base: TR-0003 Case Lid: TR-0002

Condition1:

Wrapped

Exposure Temperature:

270°F (132°C)

Exposure Time:

25 minutes

Dry Time:

50 minutes

Anatomic Radial Head Broaches (TR-BRA06, TR-BRA07, TR-BRA08, TR-BRA09, TR-BRA10) Prevacuum Steam Sterilizer Parameters Storage Case Part Numbers:

Aesculap Basket

Condition1:

Wrapped

Exposure Temperature and Time:

270°F (132°C) 4 minutes

Exposure Temperature and Time2:

273°F (134°C) 3 minutes

Dry Time:

30 minutes

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Instructions for use

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Anatomic Radial Head Solutions, Anatomic Radial Head Solutions 2: Prevacuum Steam Sterilizer Parameters ARH Solutions Storage Case Part Numbers: ARH Solutions 2 Storage Case Part Numbers:

Base: 80-2000 Case Lid: 80-2001 Base: 80-3640, 80-3692, 80-3693, 80-4040, 80-4041, 80-4042, 80-4043 Case Lid: 80-3641, 80-4068

Condition1:

Wrapped

Exposure Temperature and Time:

270°F (132°C) 4 minutes

Exposure Temperature and Time2:

273°F (134°C) 3 minutes

Dry Time:

30 minutes

1 Use sterilization packaging/wrap and other accessories appropriate for the cycle parameters recommended in these

instructions and in accordance with national regulations. Refer to PKGI-76 at www.acumed.net/ifu for sterilization in Aesculap® rigid sterilization containers. 2 The devices are compatible with exposure for 18 minutes at 134°C.

* Sterilization was validated using a STERIS Amsco 3023 Vacamatic Prevacuum sterilizer and KimGuard KC600 One-Step wrap. POST-STERILIZATION INSPECTION • Do not store or use sterile devices if they are not dry. - Moisture supports the survival of microorganisms. - Moisture remaining on wrapped or contained products after sterilization could compromise the sterile barrier. - Moisture can corrode metal and dull sharp edges. • Inspect the sterile barrier for signs of damage. Do not use the product if the sterile barrier has been compromised.

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Instructions for use

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STORAGE CONDITIONS STORAGE OF PACKAGED PRODUCT •

Items should be stored under controlled conditions in a manner that minimizes the potential for contamination per ANSI/AAMI ST79:2017. Refer to sterilization wrap or rigid container manufacturer's IFU for limits on sterile product storage time and storage requirements for temperature and humidity.

STORAGE OF STERILE PRODUCT •

Sterile product should be stored at room temperature (59-77 oF or 15-25oC) and protected from direct sunlight, pests, and high humidity.