SATELEC Wrenches Pre-Disinfection, Cleaning and Sterilization Instructions

This document is an English translation of the original French version. Reference J81000 version V6 and drawing number RA14FR010F

Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 1.3 Latest document update 2 Warnings 2.1 Precautions to be taken 2.2 Cleaning cycle limits 2.3 Containment and transportation 2.4 Preparation for pre-disinfection 3 Manual instructions 3.1 Pre-disinfection and cleaning – Manual method 3.2 Sterilisation 3.3 Inspection 3.4 Packaging 3.5 Storage 4 Automatic Instructions 4.1 Pre-disinfection and cleaning – Manual method 4.2 Cleaning, automated method 4.3 Thermal disinfection 4.4 Sterilisation 4.5 Inspection 4.6 Packaging 4.7 Storage 5 Regulations and standards 5.1 Manufacturer identification 6 Index 7 Glossary

5 5 5 5 7 7 7 7 9 11 11 11 11 11 12 13 13 13 13 13 14 14 14 15 15 17 19

1 Documentation This document contains the following information: l preparation for cleaning; l medical device disinfection; l medical device sterilisation.

1.1 Associated documentation Document title

References

Consulting electronic user instructions

J00007

Cleaning, disinfection and sterilisation instructions for tips

J02001

1.2 Electronic documentation

The user instructions for your device are available in electronic format on the specified website and not in printed format. If the website is unavailable, try again later. You can also request a free printed copy of the user instructions within seven days via our website, by telephone or in writing. The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF file reader installed to read the electronic user instructions. It is important for you to have read and understood the content of the user instructions relating to the use of your device and its accessories. Never use your device without first reading the user instructions. The device user instructions can be consulted at www.satelec.com/documents When you receive your device, you are asked to print and/or to download all documents or sections of documents that you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and to download the latest version of your device's user instructions. Users are asked to keep documentation close at hand for reference when necessary.

1.3 Latest document update 06/2022

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2 Warnings Do not clean the medical device with steel wool or abrasive cleaning products. Do not use solutions containing iodine or with a high chlorine content. The pH of the detergents and disinfectants must be between 7 and 11. Contaminated or used devices cannot be placed in sterilisation box or cleaned in a machine. The cleaning method for wrenches recommended by SATELEC, a company of Acteon group is manual or automatic. All devices must be carefully cleaned and then undergo a final sterilisation before use. The sterilization parameters are only valid for correctly cleaned devices. Wrenches require special attention during cleaning. During automatic cleaning, wrenches must be placed on suitable instrument holders or in small baskets to prevent them from being damaged during washing. It is the responsibility of the end user to ensure that all equipment used to recondition SATELEC, a company of Acteon group products is properly installed, validated, maintained and calibrated. When possible, use a washer-disinfector. Prevent the overloading of wash baskets during ultrasonic cleaning or in a washer-disinfector. Throughout the procedure, wipe away blood and debris to prevent it from drying on the surfaces. After the procedure, soiled devices must be covered with a damp cloth to prevent residue from drying. Soiled devices must also be separated from non-contaminated devices to avoid contamination of personnel or surroundings.

2.1 Precautions to be taken l l

wipe blood and debris from the wrenches to prevent them from drying on the surfaces; cover the wrench with a soft lint-free cloth dampened with purified water to prevent blood and debris from drying.

2.2 Cleaning cycle limits Repeated packaging cycles involving manual washing have little effect on the wrenches. End of service life is normally determined by wear and damage due to use.

2.3 Containment and transportation Soiled devices must be transported separately from non-contaminated devices to avoid any contamination.

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2.4 Preparation for pre-disinfection It is advisable to recondition devices as soon as possible after use. SATELEC, a company of Acteon group devices must be reconditioned within two hours of use.

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3 Manual instructions 3.1 Pre-disinfection and cleaning – Manual method Equipment: soft brush, soft lint-free swab, lint-free cloth, alkaline cleaner, ultrasonic cleaner. Minimum duration of step

Cleaning instructions

1 minute

Rinse the soiled device under cold running water. Use a soft-bristled brush, a swab or a lint-free cloth to remove most of the contamination.

10 minutes

Immerse the medical device in a freshly prepared alkaline cleaning solution in an ultrasonic cleaner for at least ten minutes. Adhere to the manufacturer's exposure time, concentration, water quality and temperature recommendations.

1 minute

Rinse the device under cold running water

2 minute 30 seconds

Wash and disinfect the medical device using an alkaline cleaning solution. Remove surface contamination using a soft brush or a swab. Wash the medical device in water to prevent contaminants from spreading into the air

1 minute

Rinse the medical device in deionised or purified water. Visually inspect the medical device. Repeat this procedure until the medical device is visibly clean. Perform a final rinse of the device using distilled or purified water. Dry the medical device using a soft lint-free cloth or medical grade clean compressed air

3.2 Sterilisation Unless otherwise specified, non-sterile products can be resterilised using validated steam sterilisation methods (ISO 17665 or national standards). SATELEC, a company of Acteon group recommends the following: Sterilisation exposure time

Sterilisation exposure temperature

Drying time

4 minutes

132 °C

15 minutes minimum and 20 minutes

18 minutes

134 °C

15 minutes minimum and 20 minutes

4 minutes

134 °C

15 minutes minimum and 20 minutes

3 minutes

134 °C

15 minutes minimum and 20 minutes

Saturated steam sterilisation with pre-vacuum The drying times vary from 15 to 60 minutes according to the following criteria: l the type of packaging material, such as a sterile barrier system or rigid reusable containers; l steam quality; l device materials; l total mass; l steriliser performance; l usual practices for the geographical area; l varying cool-down times. The manufacturer accepts no responsibility for sterilisation procedures performed by the end user or the customer that are not performed according to the manufacturer’s recommendations.

3.3 Inspection l

l l

Devices must be inspected to check that no contamination remains, that they are not corroded, dulled, discoloured or damaged. Before conditioning and sterilising the cleaned devices, check they are clean, undamaged and function properly. Damaged devices must be discarded, they must not be lubricated.

3.4 Packaging Use suitable packaging or a rigid reusable container for sterilisation; the sterile barrier system must comply with ISO standard 11607. Prevent any contact between devices and other objects that could damage their surface or the sterile

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barrier system.

3.5 Storage Storage conditions are printed on the packaging label. Packaged products should be stored in a clean, dry environment, protected from direct sunlight, pests, humidity and extreme temperatures. Use products in the order in which they are received First in, First out, taking into account the expiry date indicated on the label.

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4 Automatic Instructions 4.1 Pre-disinfection and cleaning – Manual method The manual pre-disinfection/pre-cleaning method must be performed prior to the automatic cleaning. Equipment: soft brush, soft lint-free swab, lint-free cloth, alkaline cleaner. Minimum duration of step

Cleaning instructions

30 seconds

Rinse the soiled device under cold running water. Use a soft-bristled brush, a swab or a lint-free cloth to remove most of the contamination.

1 minute

Wash and disinfect the medical device using an alkaline cleaning solution. Remove surface contamination using a soft brush or a swab. Wash the medical device in water to prevent contaminants from spreading into the air

30 seconds

Rinse the device under cold running water.

8 minutes

Immerse the medical device in a freshly prepared alkaline cleaning solution in an ultrasonic cleaner for at least ten minutes. Adhere to the manufacturer's exposure time, concentration, water quality and temperature recommendations.

1 minute

Rinse the medical device in deionised or purified water. Visually inspect the medical device. Repeat this procedure until the medical device is visibly clean. Perform a final rinse of the device using distilled or purified water. Dry the medical device using a soft lint-free cloth or medical grade clean compressed air

4.2 Cleaning, automated method Step

Minimum duration

Cleaning instructions

Pre-washing

2 minutes

Cold tap water

Washing

2 minutes

Warm tap water, hotter than 40°C. Use an alkaline cleaning solution

Neutralisation

5 minutes

Warm tap water, hotter than 40°C, with neutraliser if necessary.

Rinsing

2 minutes

Distilled or purified water, hotter than 40°C

Drying

40 minutes

At a temperature of 90°C.

4.3 Thermal disinfection Thermal disinfection at 90°C for at least five minutes.

4.4 Sterilisation Unless otherwise specified, non-sterile products can be resterilised using validated steam sterilisation methods (ISO 17665 or national standards). SATELEC, a company of Acteon group recommends the following: Sterilisation exposure time

Sterilisation exposure temperature

Drying time

4 minutes

132 °C

15 minutes minimum and 20 minutes

18 minutes

134 °C

15 minutes minimum and 20 minutes

4 minutes

134 °C

15 minutes minimum and 20 minutes

3 minutes

134 °C

15 minutes minimum and 20 minutes

Saturated steam sterilisation with pre-vacuum The drying times vary from 15 to 60 minutes according to the following criteria: l the type of packaging material, such as a sterile barrier system or rigid reusable containers; l steam quality; l device materials; l total mass;

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l l l

steriliser performance; usual practices for the geographical area; varying cool-down times. The manufacturer accepts no responsibility for sterilisation procedures performed by the end user or the customer that are not performed according to the manufacturer’s recommendations.

4.5 Inspection l

l l

Devices must be inspected to check that no contamination remains, that they are not corroded, dulled, discoloured or damaged. Before conditioning and sterilising the cleaned devices, check they are clean, undamaged and function properly. Damaged devices must be discarded, they must not be lubricated.

4.6 Packaging Use suitable packaging or a rigid reusable container for sterilisation; the sterile barrier system must comply with ISO standard 11607. Prevent any contact between devices and other objects that could damage their surface or the sterile barrier system.

4.7 Storage Storage conditions are printed on the packaging label. Packaged products should be stored in a clean, dry environment, protected from direct sunlight, pests, humidity and extreme temperatures. Use products in the order in which they are received First in, First out, taking into account the expiry date indicated on the label.

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5 Regulations and standards 5.1 Manufacturer identification SATELEC A Company of the ACTEON Group 17, avenue Gustave Eiffel ZI du Phare 33700 MERIGNAC France

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Glossary: Active implantable device – practitioner

E

7 Glossary

expiry date date up to which the medical device can be used. After this date, the medical device will need to be resterilised

A Active implantable device Active implantable medical devices are devices which are designed to be wholly or partially implanted in the human body or located in a natural orifice, and that require the supply of electricity or another energy source to operate correctly other than energy that is directly generated by the human body or gravity. (Public Health Code L.5211-1)

I Implantable device Any device designed to be completely implanted in the human body or to replace an epithelial surface or the surface of the eye, during a surgical procedure and to remain in place after surgery. An implantable device also incorporates any device designed to be partially implanted in the human body during surgery and that is intended to remain in place after the surgical procedure for a period of at least thirty days. (directive 93/42/EEC)

alcohol wipe disposable wipe soaked in an alcoholic solution designed to disinfect medical devices

autoclave container with thick walls and hermetic seal designed to steam sterilise under a pressure of several bar. For an item to be considered sterile, the theoretical probability of isolating a germ must be less than 1 in a million. This is the sterility assurance level (SAL) stipulated in standard EN 556.

M Medical device A medical device is any instrument, device, item of equipment, material or product, excluding products of human origin, or any other item used alone or with another item, including accessories and software required to ensure correct operation of the medical device, designed by the manufacturer to be used on humans for medical purposes and of which the main desired action is not obtained using pharmacological or immunological means or metabolism, but whose function may be aided by such means. Software designed by the manufacturer to be specifically used for diagnostic or therapeutic purposes also constitutes a medical device. (Public Health Code L.5211-1)

C cleaning essential pre-conditioning step to remove contamination through the physical-chemical action of a suitable product such as a detergent, combined with a mechanical action to ensure that the medical device is fully operational and clean. After cleaning, the cleanliness of the medical device components should be checked in addition to the cleanliness of the reassembled medical device. It is also important to make sure there is no damage likely to impact the safety, integrity or correct operation of the device

O operator practitioner using the medical device during a treatment

D P

disinfection voluntary and temporary removal of some germs to stop or prevent an infection, risk of infection or secondary infection by unwanted or pathogenic viruses or micro-organisms

practitioner medically qualified person responsible for buying and operating the medical device

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Glossary: pre-disinfection – washer-disinfector

pre-disinfection initial treatment to be performed on contaminated objects and equipment in order to reduce the number of micro-organisms and to facilitate subsequent cleaning. It is important to prevent residue from drying on the equipment. The other purpose of pre-disinfection is to protect personnel during the handling of instruments and to protect the environment. It is performed as soon as possible after use of the medical device within the vicinity of the place of use, prior to cleaning and in accordance with a procedure validated by the quality assurance system manager. The bactericidal, fungicidal and virucidal activities of the products used are determined in accordance with standards in force. These products are compatible with the medical devices to be handled and do not contain any substance known to be able to bind proteins

pre-vacuum forced extraction of air from inside the autoclave sterilisation chamber

S sterilisation process used to kill potentially infectious viable or revivable germs in medicines or on medical devices. By definition, the sterility of a medical device is determined by a 1 in 1,000,000 probability of finding a viable or revivable germ on (or in) a product

U ultrasonic tank or ultrasonic cleaning. Rapid part cleaning or product dissolution procedure using the mechanical effect of ultrasonic waves

user practitioner using the medical device to perform a clinical procedure. Also called operator

W washer-disinfector device designed to clean and disinfect batches of surgical instruments, anaesthetic accessories, earthenware, utensils, glassware and similar items. Generally works by washing with a detergent, thermally disinfecting and drying, sometimes by means of vacuum

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Instructions | Wrenches | J81001 | V6 | 06/2022 | RA14EN010F SATELEC | A Company of ACTEON Group 17 av. Gustave Eiffel | ZI du Phare 33700 MERIGNAC | FRANCE Tel. +33 (0) 556 34 06 07 | Fax. +33 (0) 556 34 92 92 www.acteongroup.com