SLIC Screw System Instructions for Use

English – US / PAGE 3

US

ACUMED® SLIC SCREW SYSTEM FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON DESCRIPTION: The SLIC Sc rew Device i s intended to reduce the scaphoid and lunate bones of the hand. INDICATIONS: The SLIC Screw System i s intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

CONTRAINDICATIONS: This device is contraindicated in the presence of active or latent infection, sepsis, osteoporosis, insufficient quantity and/or quality of bone, presence of cartilage degeneration on the bones, absence of potential for soft tissue healing or soft tissue reconstruction spanning the bones, or with patients who are unwilling or unable to follow post-operative care instructions. IMPLANT MATERIAL SPECIFICATIONS: The implants are made of stainless steel per ASTM F1314.

77011501-H Effective 03-2018

SURGICAL INSTRUMENT MAT ERIAL SPECIFICATIONS: The instruments are made of various grades of stainless steel, titanium, aluminum, and polymers evaluated for biocompatibility. IMPLANT INFORMATION FOR USE: The surgeon must select the type and size implant that best meets the patient’s surgical needs. Screw removal is recommended at 6-9 months or after biological healing of soft tissue has occurred. 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.  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

English – US / PAGE 4

US

mechanisms. Particular care should be paid to drivers, drill bits and instruments used for cutting or implant insertion. SURGICAL TECHNIQUES: Surgi cal techniques are avai lable 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 WARNING S: For safe effective us e 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 instructions can cause the implant and/ or treatment to fail. The implants may cause distortion and/or block the view of anatomic 77011501-H Effective 03-2018

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 effectiv e 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 sh all nev er 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. 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 replace the implant or to carry out alternative procedures. Revision surgeries with implants are not uncommon.

US

SURGICAL INSTRUMENT PRECAUTIONS: Single u se surgical instruments shall never be reused. Previous stresses may have created imperfections, which can lead to a device failure. Protect instruments against scratching and nicking, such stress concentrations can lead to failure.

English – US / PAGE 5

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 ADVERSE EFFECT S: Pos sible adv ers e effects are pain, wiped off to prevent it from drying onto the surface. discomfort, or abnormal sensations and nerve or soft tissue  All users should be qualified personnel with documented damage due to the presence of an implant or due to surgical evidence of training and competency. Training should be trauma. Fracture of the implant may occur due to excessive inclusive of current applicable guidelines and standards and activity, prolonged loading upon the device, incomplete healing, or hospital policies. excessive force exerted on the implant during insertion. Implant  Do not use metal brushes or scouring pads during manual migration and/or loosening may occur. Metal sensitivity, cleaning process. histological, allergic or adverse foreign body reaction resulting  Use cleaning agents with low foaming surfactants for manual from implantation of a foreign material may occur. Nerve or soft cleaning in order to see instruments in the cleaning solution. tissue damage, necrosis of bone or bone resorption, necrosis of Cleaning agents must be easily rinsed from instruments to the tissue or inadequate healing may result from the presence of prevent residue. an implant or due to surgical trauma.  Mineral oil or silicone lubricants should not be used on Acumed instruments. CLEANING:  Neutral pH enzymatic and cleaning agents are recommended for cleaning reusable instruments. It is very important that Implant Cleaning: Implants ar e provid ed ster ile only and alkaline cleaning agents are thoroughly neutralized and rinsed should not be re-cleaned. from instruments.  Surgical instruments must be dried thoroughly to prevent rust Insertion Instrument Cleaning: Insertion instruments are formation, even if manufactured from high grade stainless provided sterile only and should not be re-cleaned. steel. Removal Instrument Cleaning: Removal instrum ents must be

77011501-H Effective 03-2018

US



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 Instru ctions 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 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

77011501-H Effective 03-2018

English – US / PAGE 6

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. 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

English – US / PAGE 7

US

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. Step

Automated Cleaning/Disinfection Instru ctions  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. STERILIT Y: System components may be provided sterile or nonsterile.

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

Two (2) minute detergent wash with hot tap water (64–66°C/146–150°F)

6

Fifteen (15) second hot tap water rinse

7

Ten (10) second purified water rinse with optional lubricant (64-66°C/146–150°F)

8

Seven (7) minute hot air dry (116°C/240°F)

Note: Follow washer/disinfector manufacturer’s instructions explicitly

77011501-H Effective 03-2018

Sterile Product: Sterile p roduct was expos ed 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 l abeled as ster ile 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

English – US / PAGE 8

US

 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: 2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

77011501-H Effective 03-2018

Gravity Displacement Autoclave: NOT RECOMMENDED Pre-Vacuum Autoclave:

Condition:

Wrapped

Exposure Temperature:

270o F (132o C)

Exposure Time:

4 minutes

Dry Time:

30 minutes

English – US / PAGE 9

US

STORAGE INSTRUCTIONS: Store in a cool dry pl ace 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 materi als 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 r equest 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

Cautions: Federal Law (USA) rest ricts this product sale by o r on the order of a physician or hospital. Professional Use Only. 77011501-H Effective 03-2018

English– EN/ PAGE 17

EN

ACUMED® SLIC SCREW SYSTEM FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON DESCRIPTION: The SLIC Sc rew Device i s intended to reduce the scaphoid and lunate bones of the hand. INDICATIONS: The SLIC Screw System i s intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

CONTRAINDICATIONS: This device is contraindicated in the presence of active or latent infection, sepsis, osteoporosis, insufficient quantity and/or quality of bone, presence of cartilage degeneration on the bones, absence of potential for soft tissue healing or soft tissue reconstruction spanning the bones, or with patients who are unwilling or unable to follow post-operative care instructions. IMPLANT MATERIAL SPECIFICATIONS: The implants are made of stainless steel per ASTM F1314.

77011501-H Effective 03-2018

SURGICAL INSTRUMENT MAT ERIAL SPECIFICATIONS: The instruments are made of various grades of stainless steel, titanium, aluminum, and polymers evaluated for biocompatibility. IMPLANT INFORMATION FOR USE: The surgeon must select the type and size implant that best meets the patient’s surgical needs. Screw removal is recommended at 6-9 months or after biological healing of soft tissue has occurred. 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.  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

English– EN/ PAGE 18

EN

mechanisms. Particular care should be paid to drivers, drill bits and instruments used for cutting or implant insertion. SURGICAL TECHNIQUES: Surgi cal techniques are avai lable 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 WARNING S: For safe effective us e 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 instructions can cause the implant and/ or treatment to fail. The implants may cause distortion and/or block the view of anatomic 77011501-H Effective 03-2018

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 effectiv e 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 sh all nev er 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. 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 replace the implant or to carry out alternative procedures. Revision surgeries with implants are not uncommon.

EN

SURGICAL INSTRUMENT PRECAUTIONS: Single u se surgical instruments shall never be reused. Previous stresses may have created imperfections, which can lead to a device failure. Protect instruments against scratching and nicking, such stress concentrations can lead to failure.

English– EN/ PAGE 19

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 ADVERSE EFFECT S: Pos sible adv ers e effects are pain, wiped off to prevent it from drying onto the surface. discomfort, or abnormal sensations and nerve or soft tissue  All users should be qualified personnel with documented damage due to the presence of an implant or due to surgical evidence of training and competency. Training should be trauma. Fracture of the implant may occur due to excessive inclusive of current applicable guidelines and standards and activity, prolonged loading upon the device, incomplete healing, or hospital policies. excessive force exerted on the implant during insertion. Implant  Do not use metal brushes or scouring pads during manual migration and/or loosening may occur. Metal sensitivity, cleaning process. histological, allergic or adverse foreign body reaction resulting  Use cleaning agents with low foaming surfactants for manual from implantation of a foreign material may occur. Nerve or soft cleaning in order to see instruments in the cleaning solution. tissue damage, necrosis of bone or bone resorption, necrosis of Cleaning agents must be easily rinsed from instruments to the tissue or inadequate healing may result from the presence of prevent residue. an implant or due to surgical trauma.  Mineral oil or silicone lubricants should not be used on Acumed instruments. CLEANING:  Neutral pH enzymatic and cleaning agents are recommended for cleaning reusable instruments. It is very important that Implant Cleaning: Implants ar e provid ed ster ile only and alkaline cleaning agents are thoroughly neutralized and rinsed should not be re-cleaned. from instruments.  Surgical instruments must be dried thoroughly to prevent rust Insertion Instrument Cleaning: Insertion instruments are formation, even if manufactured from high grade stainless provided sterile only and should not be re-cleaned. steel. Removal Instrument Cleaning: Removal instrum ents must be

77011501-H Effective 03-2018

EN



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 Instru ctions 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 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

77011501-H Effective 03-2018

English– EN/ PAGE 20

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. 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

English– EN/ PAGE 21

EN

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. Step

Automated Cleaning/Disinfection Instru ctions  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. STERILIT Y: System components may be provided sterile or nonsterile.

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

Two (2) minute detergent wash with hot tap water (64–66°C/146–150°F)

6

Fifteen (15) second hot tap water rinse

7

Ten (10) second purified water rinse with optional lubricant (64-66°C/146–150°F)

8

Seven (7) minute hot air dry (116°C/240°F)

Note: Follow washer/disinfector manufacturer’s instructions explicitly 77011501-H Effective 03-2018

Sterile Product: Sterile p roduct was expos ed 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 l abeled as ster ile 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

English– EN/ PAGE 22

EN

 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: 2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

77011501-H Effective 03-2018

Gravity Displacement Autoclave: NOT RECOMMENDED Pre-Vacuum Autoclave:

Condition:

Wrapped

Exposure Temperature:

270o F (132o C)

Exposure Time:

4 minutes

Dry Time:

30 minutes

English– EN/ PAGE 23

EN

STORAGE INSTRUCTIONS: Store in a cool dry pl ace 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 materi als 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.

Sterilized using ethylene oxide

FURTHER INFORMATION: To r equest further material, please see the contact information listed on this document.

Date of manufacture

Sterilized using irradiation Use -by date Catalogue number Batch code Authorized representative in the European Community Manufacturer

Do not resterilize Do not re-use

Upper limit of temperature

Cautions: Professional Use Only. 77011501-H Effective 03-2018

Français– FR/ PAGE 54

FR

steam sterilization and sterility assurance in health care facilities.  La stérilisation rapide n'est pas recommandé mais, le cas échéant, doit avoir lieu dans le plus strict respect des exigences de la norme ANSI/AAMI ST79 : 2010 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

77011501-H Effective 03-2018

Autoclave à déplacement de gravité : NON RECOMMANDÉ Autoclave à pré-vide : Préparation :

Enveloppé

Température d'exposition :

132 o C (270 o F)

Temps d'exposition :

4 minutes

Temps de séchage :

30 minutes