Pioneer Surgical Technology

PIONEER Surgical Sternal Cable System Instructions

133 Pages

Sternal Cable System 437-014 Rev A, DCN 135054, JUNE 2019

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Sternal Cable System

437-014 Rev A, DCN 135054, JUNE 2019

en-US STERILE IMPLANTS NON-STERILE INSTRUMENTS

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DESCRIPTION The Sternal Cable System is a temporary implant designed to stabilize and secure bone fractures in sternal closure procedures. The system is comprised of sterile cables, crimps, leader, and needles. Sterile implants are provided in stainless steel or titanium options. Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); crimps, manufactured from CP titanium (ASTM F67) or 316L stainless steel (ASTM F138), are provided to match the corresponding cable materials. Nonimplantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al-2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel. Implants are provided sterile by gamma irradiation and supplied with instrumentation to facilitate the procedure and general manual surgical instruments. Sternal surgical instruments are for use only with Sternal Cable System implants. This information is intended to aid in using the Sternal Cable System and is not a reference for surgical technique. Refer to the surgical technique manual for instructions for implantation.

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monofilament wires in a single construct. Patient metal allergy or intolerance; Presence of severe osteopenia and/or osteoporosis, rapid bone absorption, metabolic bone disease, cancer, tumor, or tumor like condition of the bone; Inadequate tissue coverage of implant site; Undiagnosed infection, end stage malignant disease, or other unexplained disease; Interference with other critical anatomical structures such as nerves and blood vessels; Severely comminuted fractures; Any patient unwilling to follow postoperative instructions.

WARNINGS AND PRECAUTIONS The same medical/ surgical conditions or complications that apply to any surgical procedure may also occur during or following implantation of this device system. The surgeon is responsible for informing the patient of the potential risks associated with treatment, including complications and adverse reactions. The surgeon may need to perform additional surgery to address any complications or adverse reactions, which may or may not be device related. Prior to use the surgeon must become familiar with the device system and the surgical procedure.

INDICATIONS FOR USE Cardiovascular surgery - closure of the sternum following sternotomy. CONTRAINDICATIONS Contraindications may include, but are not limited to:  Presence of documented infection;  The combination of Sternal Cable System with one or more

Internal fixation devices aid the surgeon in the alignment and stabilization of bone in the anterior chest wall for fixation of fractures and reconstructive procedures. While these devices are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the device by full load bearing. Internal fixation devices are internal splints, or load sharing devices that align the fracture until

normal healing occurs. If there is delayed union, nonunion, or incomplete healing of bone; the implant can be expected to bend, break, or fracture. Therefore, it is important that immobilization of the bony segments be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size and shape of bones and soft tissue place limitations on the size and strength of implants. Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s activity level and adherence to load bearing instructions have an effect on the service life of the implant. If nonunion occurs, revise/remove the system. 

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associated with the retained fragment. Avoid over tensioning cables as they may break / fray and may cut through soft bone that is not protected and immobilized. When using electrocautery, e.g. “Bovie”, to suppress bleeding near the sternum, be mindful not to touch the cables as the multifilament strands may fray.

POTENTIAL ADVERSE EFFECTS • Irritation or inflammation of soft tissue structures surrounding implant • Cable components may cut through soft osteoporotic, osteopenic or cancellous bone if not properly protected and immobilized. • Bone formation surrounding the implant (s) making removal difficult. • Early fraying, kinking, loosening, or breaking of cable construct. • Irritation from implant(s) where there is thin or inadequate soft tissue coverage over the implant. • Loss of reduction of fractures or dislocations secondary to loosening, disassembly or breakage of the cables or secondary to cables cutting through osteoporotic bone. • Infection. • Foreign body reaction causing possible tumor-like condition. • Nonunion or delayed union of bone fracture or bony fusion. • Necrosis of bone, cessation of growth of the operated portion of the bone, rare possible neurovascular compromise, disruption of blood circulation, and/or vessel damage due to improper cable placement and/or improper assembly of the systems components. • Death

Implants are for single patient use only, on a single occasion. If reused, single use implants may not perform as intended and could cause serious injury. The components of this device are manufactured from different metals and metal alloys. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons. Instruments are subject to damage during use as well as long-term potentially damaging effects such as wear. Damage may result in significant risks to safety and/or inability to function as intended. If instruments are damaged or broken during use, metal fragments can be viewed by radiographic assessment. It is the surgeon’s responsibility to carefully consider the risks and benefits of retrieving the fragments. If the fragment is retained in the patient, it is recommended that the surgeon advise the patient of specific information regarding the fragment material, including size and location and the potential risks

MAGNETIC RESONANCE IMAGING (MRI) SAFETY These implants have not been evaluated for safety and compatibility in the MR environment by the US FDA and Health Canada. These implants have not been evaluated for heating, migration, or image artifact in the MR environment. The safety of these implants in the MR environment is unknown. Scanning a patient who has these devices may result in patient injury.

prior to cutting the cable, care should be taken to make sure that the crimps are fully crimped according to the surgical technique. POSTOPERATIVE It is extremely important that the physician provides clear directions and warnings and obtains the utmost compliance from the patient postoperatively: • Partial- or non-weight bearing may be recommended or required to achieve firm bone union. • Warn patient against sudden changes in position, strenuous activity, falls, smoking, consuming alcohol or other drugs not prescribed by the physician, steroids, non-steroidal antiinflammatory agents, aspirin, and mechanical vibrations that may loosen the devices. • If appropriate, restrict patient’s mobility at the fusion region. • If nonunion occurs, revise/remove system. • Cable product implants are temporary until healing is complete after which time they may be removed. If the device is not removed after its functional purpose is complete, the following complications may occur: o Corrosion with localized tissue reaction or pain; o The implant may migrate leading to injury; o Injury may occur as result of postoperative trauma; o Breakage, loosening, fraying may make removal difficult; o Device presence may cause pain, discomfort, abnormal sensations, increased risk of infection; and/or bone loss due to stress shielding.

PREOPERATIVE The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants, because this is a technically demanding procedure presenting a risk of serious injury to the patient. • Avoid patients with conditions that may predispose to a possible poor result or adverse effect, for example patients who smoke, and patients with poor bone stock • Never use damaged implants. Take care to prevent damage or environmental corrosion while handling, preparing, and storing components and instruments. Cable should not be unraveled, kinked or damaged and none of the components should be scratched prior to implantation.

INTRAOPERATIVE • The surgical construct should consist of one type of metal. • Acrylic bone cement should not be used with this system unless removal of the cable system is not anticipated. • Cut off excess cable flush with the crimp at completion of the procedure and after fully crimping the crimp. • Prior to the loosening of the tension in the tensioner-crimper device and

GENERAL INSTRUCTIONS FOR USE It is important to read and understand the following instructions prior to

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clinical use. Improper preparation technique may adversely affect the success of the surgical procedure. 

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All users are expected to read the instructions for use that accompany all devices being utilized with these implants. Do not re-sterilize the implants in this device system. Implants must be discarded if opened, but unused. Inspect the product, including all packaging and labeling materials carefully: o Do not use past expiration date specified on the product label o Do not use if the implant or packaging is damaged o Do not use if there are discrepancies in label information Promptly report all product defects and patient adverse events to the manufacturer (see Product Complaints section).

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CLEANING & REPROCESSING Non-Sterile Instruments If applicable, additional instructions for use are included in the surgical technique guide available from the manufacturer. Instruments are supplied clean and non-sterile.  Instruments taken directly from an unopened package must be sterilized per the instructions below prior to introduction into a sterile surgical field or (if applicable) return of the product to the manufacturer.  Unless just removed from an unopened package, instruments must be cleaned and sterilized per the instructions below prior to introduction into a sterile surgical field or (if applicable) return of the product to the manufacturer.

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To minimize corrosion and prolong the usable life of instruments used during surgery the following precautions should be taken: o Remove gross traces of blood and residues then thoroughly clean and dry immediately after use. o Do not allow soils to dry. o Saline is corrosive to stainless steel and should not be used. o High pH level detergents may cause pitting and tarnishing of the instruments. o Never use steel brushes or abrasive pads, as these rupture the passive layer of the instrument surface which can lead to corrosion. Prior to and during use, including reprocessing, inspect instruments for: o Damage such as, but not limited to, wear, discoloration, corrosion, cracking, fracture, or unrecognizable markings. o Proper function including, but not limited to, sharpness, movement of hinges and couplings, joint stability, and legible markings. Instruments that show signs of damage or an inability to function should not be used and should be returned to the manufacturer.

4. Soak devices in freshly prepared neutral pH enzymatic solution for a minimum of ten (10) minutes. 5. Rinse device using cool running tap water for a minimum of two (2) minutes. Use a syringe, pipette, or water jet to flush lumens and channels and other hard to reach areas. Actuate joints, handles and other moveable device features to rinse thoroughly under running water. 6. Prepare a neutral pH enzymatic solution per the manufacturer’s recommended instructions in warm tap water (approximately 33-43°C (92-110°F)). 7. Manually clean devices for a minimum of five (5) minutes in freshly prepared neutral pH enzymatic solution. Use a syringe, pipette, or water jet to flush lumens and channels. Use a soft-bristled brush to remove soil and debris. Actuate joints, handles, and other movable device features to expose all areas to enzymatic solutions. Clean device underwater to prevent aerosolization of contaminants. 8. Rinse device using deionized (DI) running water for a minimum of two (2) minutes. Use a syringe, pipette, or water jet to flush lumens and channels. Actuate joints, handles, and other moveable device features to rinse thoroughly under running water. 9. Visually inspect device for residual soil. If present, repeat steps 1-8 above. 10. Gently dry the device components with a soft lint-free cloth. Ensure the device is completely dry. Visually inspect the device; it should be clean, dry and residuefree. 11. Reassemble device(s), if applicable, following instructions in the surgical technique manual.

AUTOMATED (MECHANICAL) CLEANING Pre-Cleaning 1. Disassemble device(s), as applicable. See surgical technique manual for specific instructions. 2. Rinse the device components under running lukewarm tap water (22-43°C (72-110°F)) for a minimum of one (1) minute. After rinsing, remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. 3. Prepare a neutral pH enzymatic cleaning solution per the manufacturer’s instructions. 4. Fully immerse the device components in the fresh, newly prepared enzymatic cleaning solution for a minimum of five (5) minutes. 5. After soaking, manually clean the device components for a minimum of two (2) minutes using a softbristled brush to remove soil and debris from the device and device lumens. Brush the device while fully immersed to prevent aerosolization of contaminants. After cleaning, use a syringe, pipette, or water jet to flush the lumens and channels with a minimum of 10 mL of the cleaning solution. 6. Remove the device components from the cleaning solution and place in a bath of lukewarm tap water (22-43°C (72-110°F)) for a minimum of one (1) minute. Ensure the device components are fully immersed. Once the rinse time has elapsed, use a syringe, pipette, or water jet to flush the lumens and channels with a minimum of 10 ml of the water. Automated Cleaning 1. Place the device components in the automated washer. 2. Perform the automated cycle per instructions in the table below.

3. Visually inspect the device. It

water jet to flush lumens and channels and other hard to reach areas. Actuate joints, handles and other moveable device features to rinse thoroughly under running water. 6. Repeat the rinse procedure, as described in step 5, for an additional two (2) times using fresh water for a total of three (3) separate rinses.

should be clean, dry and residuefree. 4. Reassemble device(s), if applicable, following instructions in the surgical technique manual. Automated (Mechanical) Cleaning Parameters Minimum Time Cycle Detergent (Minutes) Temperature Enzymatic cleaner (neutral pH) Enzyme Hot water 4:00 prepared per wash 60°C (140°F) manufacturer’s instructions Neutral detergent Wash 2:00 Hot water prepared per manufacturer’s instructions Heated deionized or Rinse 2:00 high purity N/A water 70°C (158°F) Dry 15:00 80°C (176°F) N/A

AUTOMATED THERMAL DISINFECTION Disinfect at 93°C (200°F) for ten (10) minutes with demineralized water. STERILIZATION Independent testing has shown the following conditions to be effective. Sterilization Parameters Method Steam Pre-vacuum Cycle (Wrapped) Temperature 132° C (270° F) Exposure Time 4 Minutes Dry Time 40 Minutes

DISINFECTION The following Manual and Automated (Mechanical) disinfection instructions have been validated. Disinfection is an optional step following instrument cleaning and should not replace sterilization. MANUAL DISINFECTION 1. Ensure device is clean, free of residual enzymatic solution, and dry prior to manual disinfection using validated manual cleaning instructions. 2. Prepare device for disinfection by using appropriate size container to accommodate full submersion into solution. 3. Fully submerge device into disinfectant solution. Ensure all lumens are filled with solution to prevent air pockets. 4. Soak device in disinfectant solution for twelve (12) minutes at 20°C (68°F). 5. Rinse device using cool running water for a minimum of one (1) minute. Use a syringe, pipette, or

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Use of an FDA cleared wrap is recommended to ensure product sterility. Steam sterilization (moist heat) is the only method permitted for sterilization. Other sterilization methods are not permitted. The values specified here (duration / temperature) can achieve a sterility assurance level (SAL) of at least 10-6.

LIMITED WARRANTY THIS LIMITED WARRANTY GIVES THE ORIGINAL PURCHASER SPECIFIC LEGAL RIGHTS. THE ORIGINAL

“MANUFACTURER”), EXTENDS THIS LIMITED WARRANTY TO THE ORIGINAL PURCHASER OF THE PRODUCT. SUCH

telephone, fax or written correspondence sent by express mail. It is important to note that when filing a complaint, the following information must be included in order to properly respond to the complaint:

WARRANTY DOES NOT EXTEND TO ANY SUBSEQUENT TRANSFEREE OF THE PRODUCT. THIS LIMITED WARRANTY COVERS MALFUNCTIONS OR DEFECTS IN MATERIALS AND WORKMANSHIP FOR A PERIOD OF ONE (1) YEAR FROM THE DATE OF PURCHASE, OR FOR THE REMAINING SHELF LIFE, WHICHEVER IS LESS (THE “LIMITED WARRANTY PERIOD”). WITH RESPECT TO ANY SUCH MALFUNCTIONS OR DEFECTS OCCURRING IN THE PRODUCT DURING THIS LIMITED WARRANTY PERIOD, THE ORIGINAL PURCHASER’S REMEDY SHALL BE LIMITED AS FOLLOWS: THE MANUFACTURER, IN ITS SOLE DISCRETION, WILL EITHER: (A) REPAIR OR REPLACE SUCH PRODUCT (OR PART THEREOF) AT NO CHARGE; OR (B) REFUND TO THE ORIGINAL PURCHASER THE PURCHASE PRICE PAID FOR SUCH PRODUCT. UNDER THIS LIMITED WARRANTY, ALL OTHER EXPRESS AND IMPLIED WARRANTIES FOR THE PRODUCT, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE SPECIFICALLY EXCLUDED. IF AND TO THE EXTENT A JURISDICTION DOES NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES IN A LIMITED WARRANTY, THE MANUFACTURER ADDITIONALLY LIMITS THE DURATION OF ANY IMPLIED WARRANTY TO THE DURATION OF THE LIMITED WARRANTY PERIOD. UNDER THIS LIMITED WARRANTY, NO WARRANTIES WHETHER EXPRESS OR IMPLIED, WILL APPLY AFTER THE LIMITED WARRANTY PERIOD HAS EXPIRED. THE MAXIMUM AMOUNT OF THE MANUFACTURER’S LIABILITY UNDER THIS LIMITED WARRANTY WILL BE NO MORE THAN THE PURCHASE PRICE PAID FOR THE PRODUCT THAT IS THE SUBJECT OF ANY CLAIM UNDER THIS LIMITED WARRANTY. UNDER THIS LIMITED WARRANTY, THE MANUFACTURER DOES NOT ACCEPT ANY LIABILITY BEYOND THE REMEDIES PROVIDED IN THIS LIMITED WARRANTY, OR FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, INCLUDING, WITHOUT LIMITATION, ANY LIABILITY FOR THIRD-PARTY CLAIMS FOR DAMAGES. THIS LIMITED WARRANTY IS SUBJECT TO THE LAWS OF THE COUNTRY (WITHOUT REFERENCE TO ITS CONFLICTS OF LAW RULES) WHERE THE MANUFACTURER OF THE PRODUCT HAS ITS REGISTERED SEAT OF BUSINESS. ANY AND ALL DISPUTES IN RELATION TO THIS LIMITED WARRANTY SHALL BE EXCLUSIVELY CONFERRED TO THE COURTS IN SUCH REGISTERED SEAT OF BUSINESS OF THE MANUFACTURER.

PRODUCT COMPLAINTS Complaints or dissatisfaction with the device quality, safety, reliability, durability, effectiveness and/or performance, brought forth by a Health Care Professional, whether via a customer or user of the product, should be immediately conveyed to the attention of your distributor via

Name and address; nature of the complaint; the component(s) trade name and catalog number; applicable lot number(s); and notification of whether or not a written report from the distributor is being solicited.

Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette, MI 49855 U.S.A. Tel: (906) 226-9909 (800) 557-9909 Fax: (906) 226-4455 www.rtisurgical.com A complete symbols glossary is located at http://www.rtix.com/en_us/healthcareprofessionals/labeling

The following sections are intended for markets that require CE designations

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en-GB STERILE IMPLANTS NON-STERILE INSTRUMENTS DESCRIPTION The Sternal Cable System is a temporary implant designed to stabilize and secure bone fractures in sternal closure procedures. The system is comprised of sterile cables, crimps, leader, and needles. Sterile implants are provided in stainless steel or titanium options.

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Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel Grade 2 (ASTM F138); crimps, manufactured from CP titanium (ASTM F67) or 316L stainless steel Grade 2 (ASTM F138), are provided to match the corresponding cable materials. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al-2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel. Implants are provided sterile by gamma irradiation and supplied with instrumentation to facilitate the procedure and general manual surgical instruments.

Presence of severe osteopenia and/or osteoporosis, rapid bone absorption, metabolic bone disease, cancer, tumor, or tumor like condition of the bone; Inadequate tissue coverage of implant site; Undiagnosed infection, end stage malignant disease, or other unexplained disease; Interference with other critical anatomical structures such as nerves and blood vessels; Severely comminuted fractures; Any patient unwilling to follow postoperative instructions.

Sternal surgical instruments are for use only with Sternal Cable System implants. This information is intended to aid in using the Sternal Cable System and is not a reference for surgical technique. Refer to the surgical technique manual for instructions for implantation.

INDICATIONS FOR USE Cardiovascular surgery - closure of the sternum following sternotomy. CONTRAINDICATIONS The implant is contraindicated and should not be used including but not limited to, patients with the following:  Presence of documented infection;  Metal allergy or intolerance;

devices that align the fracture until normal healing occurs. If there is delayed union, nonunion, or incomplete healing of bone; the implant can be expected to bend, break, or fracture. Therefore, it is important that immobilization of the bony segments be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size and shape of bones and soft tissue place limitations on the size and strength of implants. Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s activity level and adherence to load bearing instructions have an effect on the service life of the implant. If nonunion occurs, revise/remove the system. 



surgeon advise the patient of specific information regarding the fragment material, including size and location and the potential risks associated with the retained fragment. Avoid over tensioning cables as they may break / fray and may cut through soft bone that is not protected and immobilized. When using electrocautery, e.g. “Bovie”, to suppress bleeding near the sternum, be mindful not to touch the cables as the multifilament strands may fray.

POTENTIAL ADVERSE EFFECTS  Irritation or inflammation of soft tissue structures surrounding implant  Cable components may cut through soft osteoporotic, osteopenic or cancellous bone if not properly protected and immobilized.  Bone formation surrounding the implant (s) making removal difficult.  Early fraying, kinking, loosening, or breaking of cable construct.  Irritation from implant(s) where there is thin or inadequate soft tissue coverage over the implant.  Loss of reduction of fractures or dislocations secondary to loosening, disassembly or breakage of the cables or secondary to cables cutting through osteoporotic bone.  Infection.  Foreign body reaction causing possible tumor-like condition.  Nonunion or delayed union of bone fracture or bony fusion.  Cessation of growth of the operated portion of the bone, rare possible neurovascular compromise, disruption of blood circulation,

and/or vessel damage due to improper cable placement and/or improper assembly of the systems components.

presenting a risk of serious injury to the patient. 

MAGNETIC RESONANCE IMAGING (MRI) SAFETY Non-clinical testing and MRI simulations were performed to evaluate the entire family or versions of the Sternal Cable System. Non-clinical testing demonstrated that the entire family or versions of this product is MR Conditional. A patient with this implant can be scanned safely in an MR system under the following conditions:  Static magnetic field of 1.5-Tesla and 3-Tesla, only  Maximum spatial gradient magnetic field of 760-gauss/cm (7.6-T/m)  Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode Under the scan conditions defined, an implant from this device system is expected to produce a maximum temperature rise of 3.3°C (5.9°F) after 15-minutes of continuous scanning (i.e., per pulse sequence).

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Avoid patients with conditions that may predispose to a possible poor result or adverse effect, for example patients who smoke, and patients with poor bone stock. Never use damaged implants. Take care to prevent damage or environmental corrosion while handling, preparing, and storing components and instruments. Cable should not be unraveled, kinked or damaged and none of the components should be scratched prior to implantation.

INTRAOPERATIVE  The surgical construct should consist of one type of metal.  Acrylic bone cement should not be used with this system unless removal of the cable system is not anticipated.  Cut off excess cable flush with the crimp at completion of the procedure and after fully crimping the crimp.  Prior to the loosening of the tension in the tensioner-crimper device and prior to cutting the cable, care should be taken to make sure that the crimps are fully crimped according to the surgical technique.

In non-clinical testing, the image artifact caused by an implant from this device system extends approximately 15-mm from the device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

POSTOPERATIVE It is extremely important that the physician provides clear directions and warnings and obtains the utmost compliance from the patient postoperatively:  Partial- or non-weight bearing may be recommended or required to achieve firm bone union.  Warn patient against sudden changes in position, strenuous

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

activity, falls, smoking, consuming alcohol or other drugs not prescribed by the physician, steroids, non-steroidal antiinflammatory agents, aspirin, and mechanical vibrations that may loosen the devices. If appropriate, restrict patient’s mobility at the fusion region. If nonunion occurs, revise/remove system. Cable product implants are temporary until healing is complete after which time they may be removed. If the device is not removed after its functional purpose is complete, the following complications may occur: o Corrosion with localized tissue reaction or pain; o The implant may migrate leading to injury; o Injury may occur as result of postoperative trauma; o Breakage, loosening, fraying may make removal difficult; o Device presence may cause pain, discomfort, abnormal sensations, increased risk of infection; and/or bone loss due to stress shielding.



GENERAL INSTRUCTIONS FOR USE It is important to read and understand the following instructions prior to clinical use. Improper preparation technique may adversely affect the success of the surgical procedure. 



Inspect the product, including all packaging and labeling materials carefully: o Do not use past expiration date specified on the product label o Do not use if the implant or packaging is damaged o Do not use if there are discrepancies in label information Promptly report all product defects and patient adverse events to the manufacturer (see Product Complaints section).

REPROCESSING INSTRUCTIONS (INSTRUMENTS) Non-Sterile Instruments If applicable, additional instructions for use are included in the surgical technique guide available from the manufacturer. Instruments are supplied clean and non-sterile.  Instruments taken directly from an unopened package must be sterilized per the instructions below prior to introduction into a sterile surgical field or (if applicable) return of the product to the manufacturer.  Unless just removed from an unopened package, instruments must be cleaned and sterilized per the instructions below prior to introduction into a sterile surgical field or (if applicable) return of the product to the manufacturer.  To minimize corrosion and prolong the usable life of instruments used during surgery the following precautions should be taken: o Remove gross traces of blood and residues then thoroughly clean and dry immediately after use. o Do not allow soils to dry. o Saline is corrosive to stainless steel and should not be used.

High pH level detergents may cause pitting and tarnishing of the instruments. o Never use steel brushes or abrasive pads, as these rupture the passive layer of the instrument surface which can lead to corrosion. Prior to and during use, including reprocessing, inspect instruments for: o Damage such as, but not limited to, wear, discoloration, corrosion, cracking, fracture, or unrecognizable markings. o Proper function including, but not limited to, sharpness, movement of hinges and couplings, joint stability, and legible markings. Instruments that show signs of damage or an inability to function should not be used and should be returned to the manufacturer.

rinse thoroughly under running water. 6. Prepare a neutral pH enzymatic solution per the manufacturer’s recommended instructions in warm tap water (approximately 33-43°C (92-110°F)). 7. Manually clean devices for a minimum of five (5) minutes in freshly prepared neutral pH enzymatic solution. Use a syringe, pipette, or water jet to flush lumens and channels. Use a soft-bristled brush to remove soil and debris. Actuate joints, handles, and other movable device features to expose all areas to enzymatic solutions. Clean device underwater to prevent aerosolization of contaminants. 8. Rinse device using deionized (DI) running water for a minimum of two (2) minutes. Use a syringe, pipette, or water jet to flush lumens and channels. Actuate joints, handles, and other moveable device features to rinse thoroughly under running water. 9. Visually inspect device for residual soil. If present, repeat steps 1-8 above. 10. Gently dry the device components with a soft lint-free cloth. Ensure the device is completely dry. Visually inspect the device; it should be clean, dry and residuefree. 11. Reassemble device(s), if applicable, following instructions in the surgical technique manual.

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CLEANING MANUAL CLEANING 1. Disassemble device(s), as applicable. See surgical technique manual for specific instructions. 2. Rinse soiled device under running, cold tap water for a minimum of two (2) minutes. Remove gross soil using a soft bristle brush or soft, lint-free cloth. 3. Prepare a neutral pH enzymatic solution per the manufacturer’s recommended instructions in warm tap water (approximately 33-43°C (92-110°F)). 4. Soak devices in freshly prepared neutral pH enzymatic solution for a minimum of ten (10) minutes. 5. Rinse device using cool running tap water for a minimum of two (2) minutes. Use a syringe, pipette, or water jet to flush lumens and channels and other hard to reach areas. Actuate joints, handles and other moveable device features to

rinsing, remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. 3. Prepare a neutral pH enzymatic cleaning solution per the manufacturer’s instructions. 4. Fully immerse the device components in the fresh, newly prepared enzymatic cleaning solution for a minimum of five (5) minutes. 5. After soaking, manually clean the device components for a minimum of two (2) minutes using a softbristled brush to remove soil and debris from the device and device lumens. Brush the device while fully immersed to prevent aerosolization of contaminants. After cleaning, use a syringe, pipette, or water jet to flush the lumens and channels with a minimum of 10 mL of the cleaning solution. 6. Remove the device components from the cleaning solution and place in a bath of lukewarm tap water (22-43°C (72-110°F)) for a minimum of one (1) minute. Ensure the device components are fully immersed. Once the rinse time has elapsed, use a syringe, pipette, or water jet to flush the lumens and channels with a minimum of 10 ml of the water. Automated Cleaning 1. Place the device components in the automated washer. 2. Perform the automated cycle per instructions in the table below. 3. Visually inspect the device. It should be clean, dry and residuefree. 4. Reassemble device(s), if applicable, following instructions in the surgical technique manual.

Automated (Mechanical) Cleaning Parameters Time Minimum Cycle (Minute Detergent Temperature s) Enzymatic cleaner (neutral pH) Enzym Hot water 4:00 prepared per e wash 60°C (140°F) manufacturer ’s instructions Neutral detergent prepared per Wash 2:00 Hot water manufacturer ’s instructions Heated deionized or N/A Rinse 2:00 high purity water 70°C (158°F) Dry

15:00

80°C (176°F)

N/A

MANUAL DISINFECTION 1. Ensure device is clean, free of residual enzymatic solution, and dry prior to manual disinfection using validated manual cleaning instructions. 2. Prepare device for disinfection by using appropriate size container to accommodate full submersion into solution. 3. Fully submerge device into disinfectant solution. Ensure all lumens are filled with solution to prevent air pockets. 4. Soak device in disinfectant solution for twelve (12) minutes at 20°C (68°F). 5. Rinse device using cool running water for a minimum of one (1) minute. Use a syringe, pipette, or water jet to flush lumens and channels and other hard to reach areas. Actuate joints, handles and

TRANSFEREE OF THE PRODUCT. THIS LIMITED WARRANTY COVERS MALFUNCTIONS OR DEFECTS IN MATERIALS AND WORKMANSHIP FOR A PERIOD OF ONE (1) YEAR FROM THE DATE OF PURCHASE, OR FOR THE REMAINING SHELF LIFE, WHICHEVER IS LESS (THE “LIMITED WARRANTY PERIOD”). WITH RESPECT TO ANY SUCH MALFUNCTIONS OR DEFECTS OCCURRING IN THE PRODUCT DURING THIS LIMITED WARRANTY PERIOD, THE ORIGINAL PURCHASER’S REMEDY SHALL BE LIMITED AS FOLLOWS: THE MANUFACTURER, IN ITS SOLE DISCRETION, WILL EITHER: (A) REPAIR OR REPLACE SUCH PRODUCT (OR PART THEREOF) AT NO CHARGE; OR (B) REFUND TO THE ORIGINAL PURCHASER THE PURCHASE PRICE PAID FOR SUCH PRODUCT. UNDER THIS LIMITED WARRANTY, ALL OTHER EXPRESS AND IMPLIED WARRANTIES FOR THE PRODUCT, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE SPECIFICALLY EXCLUDED. IF AND TO THE EXTENT A JURISDICTION DOES NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES IN A LIMITED WARRANTY, THE MANUFACTURER ADDITIONALLY LIMITS THE DURATION OF ANY IMPLIED WARRANTY TO THE DURATION OF THE LIMITED WARRANTY PERIOD. UNDER THIS LIMITED WARRANTY, NO WARRANTIES WHETHER EXPRESS OR IMPLIED, WILL APPLY AFTER THE LIMITED WARRANTY PERIOD HAS EXPIRED. THE MAXIMUM AMOUNT OF THE MANUFACTURER’S LIABILITY UNDER THIS LIMITED WARRANTY WILL BE NO MORE THAN THE PURCHASE PRICE PAID FOR THE PRODUCT THAT IS THE SUBJECT OF ANY CLAIM UNDER THIS LIMITED WARRANTY. UNDER THIS LIMITED WARRANTY, THE MANUFACTURER DOES NOT ACCEPT ANY LIABILITY BEYOND THE REMEDIES PROVIDED IN THIS LIMITED WARRANTY, OR FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, INCLUDING, WITHOUT LIMITATION, ANY LIABILITY FOR THIRD-PARTY CLAIMS FOR DAMAGES. THIS LIMITED WARRANTY IS SUBJECT TO THE LAWS OF THE COUNTRY (WITHOUT REFERENCE TO ITS CONFLICTS OF LAW RULES) WHERE THE MANUFACTURER OF THE PRODUCT HAS ITS REGISTERED SEAT OF BUSINESS. ANY AND ALL DISPUTES IN RELATION TO THIS LIMITED WARRANTY SHALL BE EXCLUSIVELY CONFERRED TO THE COURTS IN SUCH REGISTERED SEAT OF BUSINESS OF THE MANUFACTURER.

other moveable device features to rinse thoroughly under running water. 6. Repeat the rinse procedure, as described in step 5, for an additional two (2) times using fresh water for a total of three (3) separate rinses. AUTOMATED THERMAL DISINFECTION Disinfect at 93°C (200°F) for ten (10) minutes with demineralized water. STERILIZATION Independent testing has shown the following conditions to be effective. Sterilization Parameters Method Steam Pre-vacuum Cycle (Wrapped) Temperature 134° C (273° F) Exposure 5-18 Minutes Time Dry Time 40 Minutes 



Steam sterilization (moist heat) is the only method permitted for sterilization. Other sterilization methods are not permitted. The values specified here (duration / temperature) can achieve a sterility assurance level (SAL) of at least 10-6 (according to BS EN 556).

LIMITED WARRANTY THIS LIMITED WARRANTY GIVES THE ORIGINAL PURCHASER SPECIFIC LEGAL RIGHTS. THE ORIGINAL

PURCHASER MAY HAVE ADDITIONAL OR ALTERNATIVE LEGAL RIGHTS UNDER CONTRACT OR STATUTE, WHICH VARY FROM JURISDICTION TO JURISDICTION. NOTHING IN THIS LIMITED WARRANTY SHALL BE CONSTRUED AS LIMITING SUCH ADDITIONAL OR ALTERNATIVE LEGAL RIGHTS. THE LEGAL MANUFACTURER OF THE PRODUCT, AS REFLECTED ON THE PRODUCT LABEL (THE “MANUFACTURER”), EXTENDS THIS LIMITED WARRANTY TO THE ORIGINAL PURCHASER OF THE PRODUCT. SUCH WARRANTY DOES NOT EXTEND TO ANY SUBSEQUENT

correspondence sent by express mail. It is important to note that when filing a complaint, the following information must be included in order to properly respond to the complaint: Name and address; nature of the complaint; the component(s) trade name and catalog number; applicable lot number(s); and notification of whether or not a written report from the distributor is being solicited.

Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette, MI 49855 U.S.A. Tel: (906) 226-9909 (800) 557-9909 Fax: (906) 226-4455 www.rtisurgical.com Tutogen Medical GmbH (an RTI Surgical, Inc. company) Industriestrasse 6 91077 Neunkirchen am Brand Germany [email protected] Tel: +49 9134 9988 - 0 Fax: +49 9134 9988 – 99 A complete symbols glossary is located at http://www.rtix.com/en_us/healthcareprofessionals/labeling

UYGUNLUK KOŞULLARI DA DAHİL OLMAK ÜZERE TÜM DİĞER AÇIK VE ZIMNİ GARANTİLER ÖZELLİKLE HARİÇ TUTULMAKTADIR. BİR YARGI ALANININ SINIRLI BİR GARANTİDE ZIMNİ GARANTİLERİN HARİÇ TUTULMASINA İZİN VERMEDİĞİ HALDE VE İZİN VERMEDİĞİ ÖLÇÜDE, ÜRETİCİ İLAVE OLARAK TÜM ZIMNİ GARANTİLERİN SÜRESİNİ SINIRLI GARANTİ SÜRESİYLE SINIRLANDIRMAKTADIR. BU SINIRLI GARANTİ GEREĞİ, AÇIK VEYA ZIMNİ HİÇBİR GARANTİ SINIRLI GARANTİ SÜRESİNİN SONA ERMESİNDEN SONRA GEÇERLİ OLMAYACAKTIR. ÜRETİCİNİN BU SINIRLI GARANTİ GEREĞİ MAKSİMUM YÜKÜMLÜLÜK TUTARI, BU SINIRLI GARANTİ GEREĞİ HERHANGİ BİR İDDİAYA KONU OLAN ÜRÜN İÇİN ÖDENEN ALIŞ BEDELİNDEN DAHA FAZLA OLMAYACAKTIR. BU SINIRLI GARANTİ GEREĞİ VEYA KUSURLARA YÖNELİK ÜÇÜNCÜ ŞAHIS TALEPLERİ İÇİN HER TÜRLÜ YÜKÜMLÜLÜK DE DAHİL, DOLAYLI YA DA ARIZİ KUSURLAR İÇİN ÜRETİCİ BU SINIRLI GARANTİDE ÖNGÖRÜLEN YASAL ÇÖZÜM YOLLARI DIŞINDA HİÇBİR YÜKÜMLÜLÜK KABUL ETMEMEKTEDİR. BU SINIRLI GARANTİ ÜRÜNÜN ÜRETİCİSİNİN TİCARİ SİCİL KAYDININ BULUNDUĞU ÜLKENİN (KANUNLARIN ÇATIŞMASI KURALINA BAKILMAKSIZIN) KANUNLARINA TABİDİR. BU SINIRLI GARANTİYLE İLİŞKİLİ TÜM ANLAŞMAZLIKLAR MÜNHASIR OLARAK ÜRETİCİNİN TİCARİ SİCİL KAYDININ BULUNDUĞU YERİN MAHKEMELERİNE SEVK EDİLECEKTİR.

Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette, MI 49855 USA Tel.: +1 (906) 226-9909 +1 (800) 557-9909 Faks: +1 (906) 226-4455 www.rtisurgical.com Tutogen Medical GmbH (bir RTI Surgical, Inc. şirketi) Industriestrasse 6 91077 Neunkirchen am Brand Almanya [email protected] Tel: +49 9134 9988 - 0 Faks: +49 9134 9988 – 99 Eksiksiz sembol terimcesi http://www.rtix.com/en_us/healthcareprofessionals/labeling adresinden bulunabilir

ÜRÜN ŞİKAYETLERİ Cihazın kalitesi, güvenliği, güvenilirliği, dayanıklılığı, etkinliği ve/veya performansı hakkında, bir müşteri veya ürün kullanıcısı aracılığıyla bir sağlık çalışanı tarafından iletilen şikayet veya memnuniyetsizlikler, telefon, faks veya ekspres postayla yollanan yazılı formda derhal distribütörünüze iletilmelidir. Bir şikayet bildirilirken, şikayete düzgün şekilde cevap verilebilmesi için aşağıdaki bilgilerin verilmesi önemlidir: İsim ve adres, şikayetin türü, bileşenin/bileşenlerin ticari adı ve katalog numarası, uygulanabilir lot numarası/numaraları ve distribütörden yazılı bir rapor istenip istenmediği.

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