Ratcheting Compression Plating System Instructions for Use

TABLE OF CONTENTS Click on a language to navigate to the page

English – US ... 3 Dansk – DA ...11 English – EN ...19 Deutsch – DE ...27 Ελληνικά – EL ...36 Español – ES ...46 Français – FR ...55 Italiano – IT ...64 Nederlands – NL ...73 Norsk – NO ...82 Português – PT ...90 Suomi – FI ...99 Svenska – SV ...108 Türkçe – TR ...116

PKGI-71-H Effective 07-2018

US

English – US / PAGE 3

ACUMED® RATCHETING COMPRESSION PLATING SYSTEM FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON DESCRIPTION: The Acumed Ratcheting Compression Plating System and accessories are designed to provide fixation for fractures, fusions, and osteotomies. INDICATIONS: The Acumed Ratcheting Compression Plating System is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus. CONTRAINDICATIONS: Contraindications for the system are active or latent infection; sepsis; osteoporosis, insufficient quantity or quality of bone or soft tissue and material sensitivity. If material sensitivity is suspected, tests should be performed prior to implantation. Patients who are unwilling or incapable of following postoperative care instructions are contraindicated for these devices. These devices are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. PKGI-71-H Effective 07-2018

IMPLANT MATERIAL SPECIFICATIONS: The implants are made of stainless steel per ASTM F2229. SURGICAL INSTRUMENT MATERIAL SPECIFICATIONS: The instruments are made of various grades of stainless steel, titanium, aluminum, and polymers evaluated for biocompatibility. IMPLANT INFORMATION FOR USE: Physiological dimensions limit the sizes of implant appliances. The surgeon must select the type and size that best meets the patient’s requirements for close adaptation and firm seating with adequate support. Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient. SURGICAL INSTRUMENT INFORMATION FOR USE: Instruments provided with this system may be single use or reusable.  The user must refer to the instrument's label to determine whether the instrument is single use or reusable. Single use instruments are labeled with a "do not re-use" symbol as described in the Symbol Legend section, below.  Single use instruments must be discarded after a single use.

US



English – US / PAGE 4

Reusable instruments have a limited lifespan. Prior to and after each use, reusable instruments must be inspected where applicable for sharpness, wear, damage, proper cleaning, corrosion and integrity of the connecting mechanisms. Particular care should be paid to drivers, drill bits and instruments used for cutting or implant insertion.

SURGICAL TECHNIQUES: Surgical techniques are available describing the uses of this system. It is the responsibility of the surgeon to be familiar with the procedure before use of these products. In addition, it is the responsibility of the surgeon to be familiar with relevant publications and consult with experienced associates regarding the procedure before use. Surgical Techniques can be found on the Acumed website (acumed.net). IMPLANT WARNINGS: For safe effective use of the implant, the surgeon must be thoroughly familiar with the implant, the methods of application, instruments, and the recommended surgical technique for the device. The device is not designed to withstand the stress of weight bearing, load bearing, or excessive activity. Improper insertion of the device during implantation can increase the possibility of loosening or migration. The patient must be cautioned, preferably in writing, about the use, limitations, and possible adverse effects of this implant. These cautions include the possibility of the device or treatment failing as a result of loose fixation and/ or loosening, stress, excessive activity, or weight bearing or load bearing, particularly if the implant experiences increased loads due to delayed union, nonunion, or incomplete healing, and the possibility of nerve or soft tissue damage related PKGI-71-H Effective 07-2018

to either surgical trauma or the presence of the implant. The patient must be warned that failure to follow postoperative care instructions can cause the implant and/ or treatment to fail. The implants may cause distortion and/or block the view of anatomic structures on radiographic images. The components of these systems have not been tested for safety, heating, or migration in the MRI environment. Similar products have been tested and described in terms of how they may be safely used in postoperative clinical evaluation using MRI equipment 1. 1

Shellock, F. G. Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2011 Edition. Biomedical Research Publishing Group, 2011.

SURGICAL INSTRUMENT WARNINGS: For safe effective use of any Acumed instrument, the surgeon must be familiar with the instrument, the method of application, and the recommended surgical technique. Instrument breakage or damage, as well as tissue damage, can occur when an instrument is subjected to excessive loads, excessive speeds, dense bone, improper use or unintended use. The patient must be cautioned, preferably in writing as to the risks associated with these types of instruments. IMPLANT PRECAUTIONS: An implant shall never be reused. Previous stresses may have created imperfections, which can lead to a device failure. Protect implants against scratching and nicking. Such stress concentrations can lead to failure. Bending plates multiple times may weaken the device and could lead to premature implant fracture and failure. Mixing implant components from different manufacturers is not recommended for metallurgical, mechanical and functional reasons. The benefits

US

from implant surgery may not meet the patient’s expectations or may deteriorate with time, necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision surgeries with implants are not uncommon.

English – US / PAGE 5

Implants provided non-sterile that have not been used, but have become soiled, should be processed according to the following: Warnings & Precautions  Resterilization of the implants should not be performed if the implant comes into contact with contamination (e.g. biological SURGICAL INSTRUMENT PRECAUTIONS: Single use tissue contact, such as bodily fluids/ blood) unless the single surgical instruments shall never be reused. Previous stresses use device (SUD) has been reprocessed by an authorized may have created imperfections, which can lead to a device facility who has received appropriate regulatory clearance for failure. Protect instruments against scratching and nicking, such such. Cleaning a SUD after it comes into contact with human stress concentrations can lead to failure. blood or tissue constitutes reprocessing.  Do not use an implant if the surface has been damaged. Damaged implants should be discarded. ADVERSE EFFECTS: Possible adverse effects are pain, discomfort, or abnormal sensations and nerve or soft tissue  Users should wear appropriate personal protective equipment damage due to the presence of an implant or due to surgical (PPE). trauma. Fracture of the implant may occur due to excessive  All users should be qualified personnel with documented activity, prolonged loading upon the device, incomplete healing, or evidence of training and competency. Training should be excessive force exerted on the implant during insertion. Implant inclusive of current applicable guidelines, standards and migration and/or loosening may occur. Metal sensitivity, hospital policies. histological, allergic or adverse foreign body reaction resulting Manual Processing from implantation of a foreign material may occur. Nerve or soft Equipment: Soft bristled brush, neutral enzymatic cleaner or tissue damage, necrosis of bone or bone resorption, necrosis of neutral detergent with a pH ≤ 8.5. the tissue or inadequate healing may result from the presence of 1. Prepare a solution using warm tap water and detergent or an implant or due to surgical trauma. cleaner. Follow the enzymatic cleaner or detergent manufacturer’s recommendations for use paying close CLEANING: attention to the correct exposure time, temperature, water quality, and concentration. Implant Cleaning: Implants should not be reused. Acumed 2. Carefully wash the implant manually. Do not use steel wool or does not recommend cleaning of implants provided sterile. abrasive cleaners on implants. PKGI-71-H Effective 07-2018

US

3. Rinse implant thoroughly with DI or purified water. Use DI or purified water for final rinse. 4. Dry the implant using a clean, soft, lint-free cloth to avoid scratching the surface. Ultrasonic Processing Equipment: Ultrasonic cleaner, neutral enzymatic cleaner or neutral detergent with a pH ≤ 8.5. Note: Ultrasonic cleaning may cause additional damage to implants that have surface damage. 1. Prepare a solution using warm tap water and detergent or cleaner. Follow the enzymatic cleaner or detergent manufacturer’s recommendations for use paying close attention to the correct exposure time, temperature, water quality, and concentration. 2. Clean implants ultrasonically for a minimum of 15 minutes. 3. Rinse implant thoroughly with DI or purified water. Use DI or purified water for final rinse. 4. Dry the implant using a clean soft, lint-free cloth to avoid scratching the surface. Mechanical Processing Equipment: Washer/disinfector, neutral enzymatic cleaner or neutral detergent with a pH ≤ 8.5.

PKGI-71-H Effective 07-2018

English – US / PAGE 6

Minimum Time

Minimum

(minutes)

Temperature/Water

Pre-wash

2

Cold tap water

Enzyme Wash

2

Warm tap water

Wash II

5

Rinse

2

Dry

40

Cycle

Type of Detergent N/A Neutral enzymatic pH ≤ 8.5

Warm tap water

Detergent with

(>40°C)

pH ≤ 8.5

Warm DI or purified

water (>40°C) 90°C

N/A N/A

Instrument Cleaning: Acumed Instruments and Accessories must be thoroughly cleaned before reuse, following the guidelines below: Warnings & Precautions  Decontamination of reusable instruments or accessories should occur immediately after completion of the surgical procedure. Do not allow contaminated instruments to dry prior to cleaning/ reprocessing. Excess blood or debris should be wiped off to prevent it from drying onto the surface.  All users should be qualified personnel with documented evidence of training and competency. Training should be

US

inclusive of current applicable guidelines and standards and hospital policies.  Do not use metal brushes or scouring pads during manual cleaning process.  Use cleaning agents with low foaming surfactants for manual cleaning in order to see instruments in the cleaning solution. Cleaning agents must be easily rinsed from instruments to prevent residue.  Mineral oil or silicone lubricants should not be used on Acumed instruments.  Neutral pH enzymatic and cleaning agents are recommended for cleaning reusable instruments. It is very important that alkaline cleaning agents are thoroughly neutralized and rinsed from instruments.  Surgical instruments must be dried thoroughly to prevent rust formation, even if manufactured from high grade stainless steel.  All instruments must be inspected for cleanliness of surfaces, joints, and lumens, proper function, and wear and tear prior to sterilization.  Anodized aluminum must not come in contact with certain cleaning or disinfectant solutions. Avoid strong alkaline cleaners and disinfectants or solutions containing iodine, chlorine or certain metal salts. Also, in solutions with pH values above 11, the anodization layer may dissolve. Manual Cleaning/Disinfection Instructions 1. Prepare enzymatic and cleaning agents at the use-dilution and temperature recommended by the manufacturer. Fresh PKGI-71-H Effective 07-2018

English – US / PAGE 7

solutions should be prepared when existing solutions become grossly contaminated. 2. Place instruments in enzymatic solution until completely submerged. Actuate all moveable parts to allow detergent to contact all surfaces. Soak for a minimum of twenty (20) minutes. Use a nylon soft bristled brush to gently scrub instruments until all visible debris is removed. Pay special attention to hard to reach areas. Pay special attention to any cannulated instruments and clean with an appropriate bottle brush. For exposed springs, coils, or flexible features: Flood the crevices with copious amounts of cleaning solution to flush out any soil. Scrub the surface with a scrub brush to remove all visible soil from the surface and crevices. Bend the flexible area and scrub the surface with a scrub brush. Rotate the part while scrubbing to ensure that all crevices are cleaned. 3. Remove the instruments and rinse thoroughly under running water for a minimum three (3) minutes. Pay special attention to cannulations, and use a syringe to flush any hard to reach areas. 4. Place the instruments, fully submerged, in an ultrasonic unit with cleaning solution. Actuate all moveable parts to allow detergent to contact all surfaces. Sonicate the instruments for a minimum of ten (10) minutes. 5. Remove the instruments and rinse in deionized water for a minimum of three (3) minutes or until all signs of blood or soil are absent in the rinse stream. Pay special attention to cannulations, and use a syringe to flush any hard to reach areas.

US

6. Inspect instruments under normal lighting for the removal of visible soil. 7. If visible soil is seen, repeat the sonication and rinse steps above. 8. Remove excess moisture from the instruments with a clean, absorbent, nonshedding wipe. Combination Manual/Automated Cleaning and Disinfecting Instructions 1. Prepare enzymatic and cleaning agents at the use-dilution and temperature recommended by the manufacturer. Fresh solutions should be prepared when existing solutions become grossly contaminated. 2. Place instruments in enzymatic solution until completely submerged. Actuate all moveable parts to allow detergent to contact all surfaces. Soak for a minimum of ten (10) minutes. Use a nylon soft bristled brush to gently scrub instruments until all visible debris is removed. Pay special attention to hard to reach areas. Pay special attention to any cannulated instruments and clean with an appropriate bottle brush. Note: Use of a sonicator will aid in thorough cleaning of instruments. Using a syringe or water jet will improve flushing of difficult to reach areas and any closely mated surface. 3. Remove instruments from enzyme solution and rinse in deionized water for a minimum of one (1) minute. 4. Place instruments in a suitable washer/ disinfector basket and process through a standard washer/disinfector cycle. The following minimum parameters are essential for thorough cleaning and disinfection.

PKGI-71-H Effective 07-2018

English – US / PAGE 8

Step

Description

1

Two (2) minute prewash with cold tap water

2

Twenty (20) second enzyme spray with hot tap water

3

One (1) minute enzyme soak

4

Fifteen (15) second cold tap water rinse (X2)

5 6 7 8

Two (2) minute detergent wash with hot tap water (64-66°C/146-150°F) Fifteen (15) second hot tap water rinse Ten (10) second purified water rinse with optional lubricant (64-66°C/146-150°F) Seven (7) minute hot air dry (116°C/240°F)

Note: Follow washer/disinfector manufacturer’s instructions explicitly

Automated Cleaning/Disinfection Instructions  Automated washer/dryer systems are not recommended as the only cleaning method for surgical instruments.  An automated system may be used as a follow up process to manual cleaning.  Instruments should be thoroughly inspected prior to sterilization to ensure effective cleaning.

US

STERILITY: System components may be provided sterile or nonsterile. Sterile Product: Sterile product was exposed to a minimum dose of 25.0-kGy gamma irradiation. Acumed does not recommend resterilization of sterile-packaged product. If sterile packaging is damaged, the incident must be reported to Acumed. The product must not be used, and must be returned to Acumed. Non-Sterile Product: Unless clearly labeled as sterile and provided in an unopened sterile package provided by Acumed, all implants and instruments must be considered nonsterile, and sterilized by the hospital prior to use. Sterilization of nonsterile devices has been validated using the sterilization parameters listed below, where devices are provided in fully-loaded trays with all parts placed appropriately. Sterilization Methods  Consult your equipment manufacturer’s written instructions for specific sterilizer and load configuration instructions.  Follow current AORN “Recommended Practices for Sterilization in Perioperative Practice Settings” and ANSI/AAMI ST79: 2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.  Flash sterilization is not recommended, but if used, should only be performed according to requirements of ANSI/AAMI ST79:

PKGI-71-H Effective 07-2018

English – US / PAGE 9

2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 80-1682/80-1683/80-1685 This tray has been validated to the parameters below: Gravity Displacement Autoclave: NOT RECOMMENDED Pre-Vacuum Autoclave: Condition:

Wrapped

Exposure Temperature:

270o F (132o C)

Exposure Time:

4 minutes

Dry Time:

30 minutes

US

English – US / PAGE 10

STORAGE INSTRUCTIONS: Store in a cool dry place and keep away from direct sunlight. Prior to use, inspect product package for signs of tampering, or water contamination. Use oldest lots first.

SYMBOL LEGEND Consult instructions for use Caution

APPLICABILITY: These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. FURTHER INFORMATION: To request further material, please see the contact information listed on this document.

Sterilized using ethylene oxide Sterilized using irradiation Use-by date Catalogue number Batch code Authorized representative in the European Community Manufacturer Date of manufacture Do not resterilize Do not re-use Upper limit of temperature

Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician. For Professional Use Only. PKGI-71-H Effective 07-2018

EN

English– EN/ PAGE 19

ACUMED® RATCHETING COMPRESSION PLATING SYSTEM FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON

IMPLANT MATERIAL SPECIFICATIONS: The implants are made of stainless steel per ASTM F2229.

DESCRIPTION: The Acumed Ratcheting Compression Plating System and accessories are designed to provide fixation for fractures, fusions, and osteotomies.

SURGICAL INSTRUMENT MATERIAL SPECIFICATIONS: The instruments are made of various grades of stainless steel, titanium, aluminum, and polymers evaluated for biocompatibility.

INDICATIONS: The Acumed Ratcheting Compression Plating System is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

IMPLANT INFORMATION FOR USE: The surgeon must select the type and size that best meets the patient’s requirements for close adaptation and firm seating with adequate support. Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.

CONTRAINDICATIONS: Contraindications for the system are active or latent infection; sepsis; osteoporosis, insufficient quantity or quality of bone or soft tissue and material sensitivity. If material sensitivity is suspected, tests should be performed prior to implantation. Patients who are unwilling or incapable of following postoperative care instructions are contraindicated for these devices. These devices are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. PKGI-71-H Effective 07-2018

SURGICAL INSTRUMENT INFORMATION FOR USE: Instruments provided with this system may be single use or reusable.  The user must refer to the instrument's label to determine whether the instrument is single use or reusable. Single use instruments are labeled with a "do not re-use" symbol as described in the Symbol Legend section, below.  Single use instruments must be discarded after a single use.  Reusable instruments have a limited lifespan. Prior to and after each use, reusable instruments must be inspected

EN

English– EN/ PAGE 20

where applicable for sharpness, wear, damage, proper cleaning, corrosion and integrity of the connecting mechanisms. Particular care should be paid to drivers, drill bits and instruments used for cutting or implant insertion. SURGICAL TECHNIQUES: Surgical techniques are available describing the uses of this system. It is the responsibility of the surgeon to be familiar with the procedure before use of these products. In addition, it is the responsibility of the surgeon to be familiar with relevant publications and consult with experienced associates regarding the procedure before use. Surgical Techniques can be found on the Acumed website (acumed.net). IMPLANT WARNINGS: For safe effective use of the implant, the surgeon must be thoroughly familiar with the implant, the methods of application, instruments, and the recommended surgical technique for the device. The device is not designed to withstand the stress of weight bearing, load bearing, or excessive activity. Improper insertion of the device during implantation can increase the possibility of loosening or migration. The patient must be cautioned, preferably in writing, about the use, limitations, and possible adverse effects of this implant. These cautions include the possibility of the device or treatment failing as a result of loose fixation and/ or loosening, stress, excessive activity, or weight bearing or load bearing, particularly if the implant experiences increased loads due to delayed union, nonunion, or incomplete healing, and the possibility of nerve or soft tissue damage related to either surgical trauma or the presence of the implant. The patient must be warned that failure to follow postoperative care PKGI-71-H Effective 07-2018

instructions can cause the implant and/ or treatment to fail. The implants may cause distortion and/or block the view of anatomic structures on radiographic images. The components of these systems have not been tested for safety, heating, or migration in the MRI environment. Similar products have been tested and described in terms of how they may be safely used in postoperative clinical evaluation using MRI equipment 1. 1

Shellock, F. G. Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2011 Edition. Biomedical Research Publishing Group, 2011.

SURGICAL INSTRUMENT WARNINGS: For safe effective use of any Acumed instrument, the surgeon must be familiar with the instrument, the method of application, and the recommended surgical technique. Instrument breakage or damage, as well as tissue damage, can occur when an instrument is subjected to excessive loads, excessive speeds, dense bone, improper use or unintended use. The patient must be cautioned, preferably in writing as to the risks associated with these types of instruments. IMPLANT PRECAUTIONS: An implant shall never be reused. Previous stresses may have created imperfections, which can lead to a device failure. Protect implants against scratching and nicking. Such stress concentrations can lead to failure. Bending plates multiple times may weaken the device and could lead to premature implant fracture and failure. Mixing implant components from different manufacturers is not recommended for metallurgical, mechanical and functional reasons. The benefits from implant surgery may not meet the patient’s expectations or may deteriorate with time, necessitating revision surgery to

EN

replace the implant or to carry out alternative procedures. Revision surgeries with implants are not uncommon.

English– EN/ PAGE 21

Warnings & Precautions  Resterilization of the implants should not be performed if the implant comes into contact with contamination (e.g. biological tissue contact, such as bodily fluids/ blood) unless the single SURGICAL INSTRUMENT PRECAUTIONS: Single use use device (SUD) has been reprocessed by an authorized surgical instruments shall never be reused. Previous stresses facility who has received appropriate regulatory clearance for may have created imperfections, which can lead to a device such. Cleaning a SUD after it comes into contact with human failure. Protect instruments against scratching and nicking, such blood or tissue constitutes reprocessing. stress concentrations can lead to failure.  Do not use an implant if the surface has been damaged. Damaged implants should be discarded. ADVERSE EFFECTS: Possible adverse effects are pain,  Users should wear appropriate personal protective equipment discomfort, or abnormal sensations and nerve or soft tissue (PPE). damage due to the presence of an implant or due to surgical trauma. Fracture of the implant may occur due to excessive  All users should be qualified personnel with documented activity, prolonged loading upon the device, incomplete healing, or evidence of training and competency. Training should be excessive force exerted on the implant during insertion. Implant inclusive of current applicable guidelines, standards and migration and/or loosening may occur. Metal sensitivity, hospital policies. histological, allergic or adverse foreign body reaction resulting Manual Processing from implantation of a foreign material may occur. Nerve or soft Equipment: Soft bristled brush, neutral enzymatic cleaner or tissue damage, necrosis of bone or bone resorption, necrosis of neutral detergent with a pH ≤ 8.5. the tissue or inadequate healing may result from the presence of 1. Prepare a solution using warm tap water and detergent or an implant or due to surgical trauma. cleaner. Follow the enzymatic cleaner or detergent manufacturer’s recommendations for use paying close CLEANING: attention to the correct exposure time, temperature, water quality, and concentration. Implant Cleaning: Implants should not be reused. Acumed 2. Carefully wash the implant manually. Do not use steel wool or does not recommend cleaning of implants provided sterile. abrasive cleaners on implants. Implants provided non-sterile that have not been used, but have 3. Rinse implant thoroughly with DI or purified water. Use DI or become soiled, should be processed according to the following: purified water for final rinse. PKGI-71-H Effective 07-2018

EN

4. Dry the implant using a clean, soft, lint-free cloth to avoid scratching the surface. Ultrasonic Processing Equipment: Ultrasonic cleaner, neutral enzymatic cleaner or neutral detergent with a pH ≤ 8.5. Note: Ultrasonic cleaning may cause additional damage to implants that have surface damage. 1. Prepare a solution using warm tap water and detergent or cleaner. Follow the enzymatic cleaner or detergent manufacturer’s recommendations for use paying close attention to the correct exposure time, temperature, water quality, and concentration. 2. Clean implants ultrasonically for a minimum of 15 minutes. 3. Rinse implant thoroughly with DI or purified water. Use DI or purified water for final rinse. 4. Dry the implant using a clean soft, lint-free cloth to avoid scratching the surface. Mechanical Processing Equipment: Washer/disinfector, neutral enzymatic cleaner or neutral detergent with a pH ≤ 8.5.

PKGI-71-H Effective 07-2018

English– EN/ PAGE 22

Minimum Time

Minimum

(minutes)

Temperature/Water

Pre-wash

2

Cold tap water

Enzyme Wash

2

Warm tap water

Wash II

5

Rinse

2

Dry

40

Cycle

Type of Detergent N/A Neutral enzymatic pH ≤ 8.5

Warm tap water

Detergent with

(>40°C)

pH ≤ 8.5

Warm DI or purified

water (>40°C) 90°C

N/A N/A

Instrument Cleaning: Acumed Instruments and Accessories must be thoroughly cleaned before reuse, following the guidelines below: Warnings & Precautions  Decontamination of reusable instruments or accessories should occur immediately after completion of the surgical procedure. Do not allow contaminated instruments to dry prior to cleaning/ reprocessing. Excess blood or debris should be wiped off to prevent it from drying onto the surface.  All users should be qualified personnel with documented evidence of training and competency. Training should be

EN

inclusive of current applicable guidelines and standards and hospital policies.  Do not use metal brushes or scouring pads during manual cleaning process.  Use cleaning agents with low foaming surfactants for manual cleaning in order to see instruments in the cleaning solution. Cleaning agents must be easily rinsed from instruments to prevent residue.  Mineral oil or silicone lubricants should not be used on Acumed instruments.  Neutral pH enzymatic and cleaning agents are recommended for cleaning reusable instruments. It is very important that alkaline cleaning agents are thoroughly neutralized and rinsed from instruments.  Surgical instruments must be dried thoroughly to prevent rust formation, even if manufactured from high grade stainless steel.  All instruments must be inspected for cleanliness of surfaces, joints, and lumens, proper function, and wear and tear prior to sterilization.  Anodized aluminum must not come in contact with certain cleaning or disinfectant solutions. Avoid strong alkaline cleaners and disinfectants or solutions containing iodine, chlorine or certain metal salts. Also, in solutions with pH values above 11, the anodization layer may dissolve. Manual Cleaning/Disinfection Instructions 1. Prepare enzymatic and cleaning agents at the use-dilution and temperature recommended by the manufacturer. Fresh PKGI-71-H Effective 07-2018

English– EN/ PAGE 23

solutions should be prepared when existing solutions become grossly contaminated. 2. Place instruments in enzymatic solution until completely submerged. Actuate all moveable parts to allow detergent to contact all surfaces. Soak for a minimum of twenty (20) minutes. Use a nylon soft bristled brush to gently scrub instruments until all visible debris is removed. Pay special attention to hard to reach areas. Pay special attention to any cannulated instruments and clean with an appropriate bottle brush. For exposed springs, coils, or flexible features: Flood the crevices with copious amounts of cleaning solution to flush out any soil. Scrub the surface with a scrub brush to remove all visible soil from the surface and crevices. Bend the flexible area and scrub the surface with a scrub brush. Rotate the part while scrubbing to ensure that all crevices are cleaned. 3. Remove the instruments and rinse thoroughly under running water for a minimum three (3) minutes. Pay special attention to cannulations, and use a syringe to flush any hard to reach areas. 4. Place the instruments, fully submerged, in an ultrasonic unit with cleaning solution. Actuate all moveable parts to allow detergent to contact all surfaces. Sonicate the instruments for a minimum of ten (10) minutes. 5. Remove the instruments and rinse in deionized water for a minimum of three (3) minutes or until all signs of blood or soil are absent in the rinse stream. Pay special attention to cannulations, and use a syringe to flush any hard to reach areas.

EN

6. Inspect instruments under normal lighting for the removal of visible soil. 7. If visible soil is seen, repeat the sonication and rinse steps above. 8. Remove excess moisture from the instruments with a clean, absorbent, nonshedding wipe. Combination Manual/Automated Cleaning and Disinfecting Instructions 1. Prepare enzymatic and cleaning agents at the use-dilution and temperature recommended by the manufacturer. Fresh solutions should be prepared when existing solutions become grossly contaminated. 2. Place instruments in enzymatic solution until completely submerged. Actuate all moveable parts to allow detergent to contact all surfaces. Soak for a minimum of ten (10) minutes. Use a nylon soft bristled brush to gently scrub instruments until all visible debris is removed. Pay special attention to hard to reach areas. Pay special attention to any cannulated instruments and clean with an appropriate bottle brush. Note: Use of a sonicator will aid in thorough cleaning of instruments. Using a syringe or water jet will improve flushing of difficult to reach areas and any closely mated surface. 3. Remove instruments from enzyme solution and rinse in deionized water for a minimum of one (1) minute. 4. Place instruments in a suitable washer/ disinfector basket and process through a standard washer/disinfector cycle. The following minimum parameters are essential for thorough cleaning and disinfection.

PKGI-71-H Effective 07-2018

English– EN/ PAGE 24

Step

Description

1

Two (2) minute prewash with cold tap water

2

Twenty (20) second enzyme spray with hot tap water

3

One (1) minute enzyme soak

4

Fifteen (15) second cold tap water rinse (X2)

5 6 7 8

Two (2) minute detergent wash with hot tap water (64-66°C/146-150°F) Fifteen (15) second hot tap water rinse Ten (10) second purified water rinse with optional lubricant (64-66°C/146-150°F) Seven (7) minute hot air dry (116°C/240°F)

Note: Follow washer/disinfector manufacturer’s instructions explicitly

Automated Cleaning/Disinfection Instructions  Automated washer/dryer systems are not recommended as the only cleaning method for surgical instruments.  An automated system may be used as a follow up process to manual cleaning.  Instruments should be thoroughly inspected prior to sterilization to ensure effective cleaning.

EN

STERILITY: System components may be provided sterile or nonsterile. Sterile Product: Sterile product was exposed to a minimum dose of 25.0-kGy gamma irradiation. Acumed does not recommend resterilization of sterile-packaged product. If sterile packaging is damaged, the incident must be reported to Acumed. The product must not be used, and must be returned to Acumed. Non-Sterile Product: Unless clearly labeled as sterile and provided in an unopened sterile package provided by Acumed, all implants and instruments must be considered nonsterile, and sterilized by the hospital prior to use. Sterilization of nonsterile devices has been validated using the sterilization parameters listed below, where devices are provided in fully-loaded trays with all parts placed appropriately. Sterilization Methods  Consult your equipment manufacturer’s written instructions for specific sterilizer and load configuration instructions.  Follow current AORN “Recommended Practices for Sterilization in Perioperative Practice Settings” and ANSI/AAMI ST79: 2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.  Flash sterilization is not recommended, but if used, should only be performed according to requirements of ANSI/AAMI ST79:

PKGI-71-H Effective 07-2018

English– EN/ PAGE 25

2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 80-1682/80-1683/80-1685 This tray has been validated to the parameters below: Gravity Displacement Autoclave: NOT RECOMMENDED Pre-Vacuum Autoclave: Condition:

Wrapped

Exposure Temperature:

270o F (132o C)

Exposure Time:

4 minutes

Dry Time:

30 minutes

EN

English– EN/ PAGE 26

STORAGE INSTRUCTIONS: Store in a cool dry place and keep away from direct sunlight. Prior to use, inspect product package for signs of tampering, or water contamination. Use oldest lots first.

SYMBOL LEGEND Consult instructions for use Caution

APPLICABILITY: These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. FURTHER INFORMATION: To request further material, please see the contact information listed on this document.

Sterilized using ethylene oxide Sterilized using irradiation Use-by date Catalogue number Batch code Authorized representative in the European Community Manufacturer Date of manufacture Do not resterilize Do not re-use Upper limit of temperature

Caution: For Professional Use Only. PKGI-71-H Effective 07-2018