Instructions for sterilization

Cleaning and sterilizing of surgical instruments Always clean new instruments prior to first sterilization. Strictly adhere to dosage, exposure time and temperature specifications provided for disinfecting and cleaning. Process used instruments as soon as possible. Always open hinged instruments prior to processing. As far as possible, disassemble all instruments before processing them. Do not overload washer-disinfectors and ultrasonic cleaning devices. Ensure that instruments are fully accessed in washer-disinfectors and sonic baths. Be sure to use only suitable cleaning tools and accessories. Never use metal brushes or metal sponges for manual cleaning. Rinse thoroughly and carefully after cleaning. If possible, use demineralized water. Dry sufficiently after rinsing. Worn, corroded, deformed, porous or otherwise damaged instruments must be sorted out and discarded. For hygienic reasons, instruments must be sent through the complete preparation cycle before they are submitted for repair. Hinged/jointed instruments must be treated with a paraffin oil-based lubricant (not applicable to flexible endoscopes and accessories). Following assembly, each instrument should be subjected to a functional test. Hinged instruments must be lubricated prior to carrying out the test. Instruments with a ratchet should only be closed at the first tooth/notch before sterilization. Sterilization is no substitute for cleaning! ROLAN INSTRUMENTS GMBH

Reusable surgical instruments With the purchase of these instruments, you have acquired high-quality products. The proper handling and use is described below. In order to minimize hazards to patients and users, we ask that you carefully observe the instructions for use. Only trained professionals may use, disinfect, clean and sterilize the instruments. Tests The instruments must be checked to make sure they work properly before every use. Damage to the surface, such as scratches, cracks, nicks, dents, etc., as well as bent parts, are indications that they may not be used. The products are then to be repaired or are to be disposed of according to hospital procedure. Do not use any damaged products! Area of use We manufacture our instruments as standard instruments for operative use in general surgery. The treating physician, however, is responsible for the selection of instruments for certain applications or for operative use. The physician is also responsible for the appropriate training and sufficient information for the OP personnel, and for having sufficient experience using the instruments. Handling The instruments may not be overstressed by twisting or levering, since this can lead to instrument parts becoming damaged or broken. Risks · Injury to nerves, vessels and tissue · Bleeding · Infections Complications In general, complications seldom occur. The frequency and severity of the complication depends on the type of examination. Combination with other products / instruments The products from ROLAN Instruments GmbH may not be combined with products, components and instruments from other manufacturers under any circumstances. Combinations with products from other manufacturers may negatively affect the result of the operation and are not allowed, since the used components might not be compatible with one another. It is recommended to only use instruments and accessories from ROLAN Instruments GmbH. Disposal If the instruments should no longer be reparable and treatable, these are to be disposed of according to hospital procedure. Materials The used materials are stainless steels according to EN ISO 7153-1 Treatment instructions Process:

• Cleaning • Disinfection • Sterilization with hot steam (EN 554)

Warnings:

The instruments are delivered non-sterilized and must be cleaned before use, and disinfected and sterilized, if necessary. The instruments may only be treated by persons with the necessary specialized knowledge and training, and who can judge the potential risks with the corresponding effects.

Limitation of re-treating:

Frequent re-treating has little effect on the instruments. The end of the product lifetime is usually determined by wear and damage from use. They are then to be disposed of according to hospital procedure. Do not use any damaged products!

Instructions Place of use:

Remove surface contamination with a disposable cloth / paper towel. It is recommended to reprocess the instruments as soon as possible after they have been used. Directly after use, they can be disinfected by hand in order to reduce the risk of infection for the user. Here, the instruments are placed in a disinfection solution. Make sure that the instruments are fully immersed in the disinfection solution, and that no air bubbles are formed. Follow the instructions of the manufacturer of the disinfection solution.

Preparation for decontamination:

If instruments can be taken apart, do this before treating them.

Cleaning: Manual

• After using the instruments, immediately clean them externally with a soft cloth, sponge and a suitable, soft disinfected brush in a cleaning solution.

• The used cleaning solution must be suitable for cleaning steel products. • Prepare the cleaning solution concentration and allow the instruments to soak in it exactly according to manufacturer specifications.

• The cleaning solution should not be foamy and should be suitable for manual cleaning. • Thoroughly rinse instruments with channels and hollow spaces. • Carry out brushing and all other cleaning steps under the surface of the liquid in order to avoid splashing contaminated liquid.

• Remove instruments from the cleaning solution. • After rinsing with clear, running water, dry well. • Change the cleaning solution at least once daily, or once the solution is visibly contaminated.

Reusable surgical instruments Ultrasound cleaning:

• Use an ultrasound device, which is suitable for medical use. • The ultrasound cleaning bath should be warmed up to a temperature, which is recommended by the manufacturers of the cleaning or disinfection solutions. Usually, temperatures between 40°C and 50°C are required to have a cleaning effect. Place instruments in the wire basket. Place instruments in the ultrasound cleaning bath with a frequency of approx. 40 KHz for 5 minutes. After the ultrasound cleaning, the instruments must be rinsed with clear, running water and dried. The used cleaning / disinfection solutions must be prepared according to the manufacturer’s specifications. • An overdose of the cleaning/disinfection solution is to be avoided. • The used cleaning or disinfection solutions must be suitable for cleaning steel products.

• • • • •

The following items should also be observed:

• The wire basket of the ultrasound device must be sufficiently large and deep to guarantee that the • • • • • • • •

instruments are completely immersed. Products must be completely covered by the cleaning solution. Only use wire basins, which don’t negatively affect the cleaning result. Don’t overload wire basins. Avoid “acoustic shadows”. Fill all channels and hollow spaces with cleaning solutions, without air bubbles. Remove instruments from the ultrasound device. Blow through all channels with air to remove any remaining liquid. Change the cleaning solution in the ultrasound bath at least once a day, and more often when contamination is visible.

Rinsing

• • • • •

Place cleaned instruments in a sink with clean tap water. Use fresh tap water for every rinsing. Rinse all channels completely and thoroughly with water. Rinse off external surfaces of the instruments thoroughly with tap water. Remove instruments from the water. Blow through all channels with air to remove any remaining rinse water.

Disinfection: Manual

• • • • •

Cleaning and disinfection: Automatic

If the possibility exists to clean the instruments with a machine, this is preferable to manual cleaning, since a standardized process can best be reached this way.

The used disinfecting solution must be suitable for disinfecting steel products. Place cleaned instruments in a tub with a disinfecting solution. Fill all channels and hollow spaces with the disinfecting solution, free of air bubbles. Cover the tub with its lid. Prepare the disinfecting solution concentration and allow the instruments to soak in it according to manufacturer specifications. • Remove the instruments from the disinfecting solution with fresh disposable gloves.

• The used cleaning/disinfecting solution must be suitable for steel products. • The cleaning solution should not be foamy. • The basket or immersion basin of the machine must be loaded according to the manufacturer’s specifications.

• The instruments are to be placed so that channels and hollow spaces are completely and thoroughly rinsed.

• The special features of the device model are to be taken into consideration. Disinfection: Automatic

• Close the machine, select the program and start. • After the end of the program, check whether all program stages were carried out and all control parameters are fulfilled.

• Open the cleaning / disinfection device and remove the instruments with disinfected hands or with fresh disposable gloves.

• Dry channels and hollow spaces with compressed air. If necessary, dry the instruments with a lint-free cloth.

Reusable surgical instruments Neutralization / clear rinsing

• Place disinfected instruments in a sink/tub with microbiologically pure/sterile water. Use fresh water for each instrument.

• Rinse external surfaces of the instruments, all channels and hollow spaces thoroughly with water in order to remove any remaining disinfectant.

• Remove instruments from the water. Drying and function test:

• Dry external surfaces with a lint-free cloth and with compressed air. • Dry all channels and hollow spaces completely with compressed air. • Check instruments to see whether they function correctly.

Maintenance, checks

Sort out damaged instruments and submit them for repairs. Before sending them to the repair service, it is imperative that the instruments be sterilized.

Packaging:

The instruments should be packaged in a suitable container or a suitable sterilization package before sterilization (EN 868, Parts 1- 10). The sterilization packaging depends on the sterilization method, transport and storage. The packaging has a considerable influence on the sterilization result. The packaging is to be selected so that the instruments fit in it. Use a sterilization indicator for the packaging and write down the sterilization and expiration date on the packaging.

Sterilization:

Recommended sterilization method:

Steam sterilization with saturated steam with a fractionizing vacuum (EN 554)

Recommended temperature:

134 °C

Recommended pressure:

3 bar

Duration:

> 5 min

Drying time:

> 5 min

. After sterilization, check the packaging of the sterilized instruments for damage. Check the sterilization indicators Storage:

Store the sterilized, packaged instruments in a closed cabinet, protected from dust, moisture and temperature fluctuations.

Additional information:

Further information for the treatment of medical products: • Internet: http://www.rki.de • Internet: http://www.a-k-i.org • Hygienic requirements for treating medical products, recommendation of the commission for hospital hygiene and infection prevention at the Robert Koch Institute (RKI) and the Federal Institute for Medicine and Medical Products (BfArM) with regard to the “Hygienic requirements for treating medical products.” • For information, since the product can’t be re-sterilized: EN ISO 17664 Sterilization of medical products. Information to be provided by the manufacturer for the treatment of re-sterilizable medical products (ISO 17664:2004)

Manufacturer contact info:

See manufacturer and service address.

The above-listed instructions were validated as SUITABLE by the medical product manufacturer for the treatment of a medical product so that it can be used again. The one who performs the treatment is responsible for making sure that the actual treatment carried out with the used equipment, material and personnel in the treatment facility achieves the desired results. For this, usually validation and routine monitoring of the method is required. Guarantee The products are made of high-quality materials and undergo a quality control before delivery. If errors should still occur, please refer to our service department. We cannot make any guarantees as to whether the products are suitable for the operation in question. That must be determined by the user himself. We can accept no liability for random or resulting damage. ROLAN Instruments GmbH accepts no liability if it can be proven that these instructions for use were violated. Attention: In case the instruments are used on patients who have Creutzfeldt-Jakob disease or an HIV infection, we refuse to take any responsibility if they are reused. Manufacturer and Service Address ROLAN Instruments GmbH Schlangeneckstr. 16 79346 Endingen/Germany Tel. +49 7642 920516 FAX: +49 7642 920517 E-Mail: [email protected]

Instructions for Use · Sterile Container Systems With the purchase of this sterilisation container you have chosen a high quality product, the correct handling and use of which are described in the following. In order to keep risks and unnecessary burdening of the patient, the user and third parties as low as possible, we request that you carefully look through these instructions for use and keep them for further reference. Caution: Federal Law restricts this device to sale by or on the order of a physician 1 Testing The sterilisation containers have to be checked every time before use to ensure their correct functionality. Damage to the fasteners, seals, filter holders and filters and bent and dented parts means that the sterilisation containers have to be repaired and should not be used. Do not use any damaged sterilisation containers. 2 Field of application Our sterilisation containers can be used as standard containers for the sterilisation of material to be sterilized with moist heat according to EN 554 / ISO 11134 and as containers for waste disposal. Dimensions and shapes can be taken from our product catalogue, respectively. The sterilisation containers are intended for sterilisation, as packaging, for the transport and storage of medical instruments, implantable medical devices, operating laundry, operating overalls, swabs, dressings and other medical auxiliaries. Complex instruments like Endoscopes, instruments with a lumen, compressed air-driven instruments or power systems and instruments with cannulae are to be prepared according to the manufacturers’ instructions for sterilisation and to be sterilized accordingly. The sterilisation containers serve for the transport, sterilisation, storage, preparation and disposal of sterile materials. Sterile material maintains its sterility from several weeks to up to 6 months under normal aseptic conditions, in unopened sterilisation containers and with undamaged sterile filters. Usually the storage period depends on the storage conditions and must be defined by the responsible specialist hygiene personnel. In the case of particularly high demands on sterility, for example, shorter storage times or additional packaging should be used. The requirements and recommendations according to DIN 58953-9 should be taken into account when determining the storage period and the storage conditions. Reference values for storage periods (according to DIN 58953-9):

Sterile material packaging

Type of packaging

Sterilisation containers according to DIN 58952-2 and -3

Storage period Storage unprotected

Storage protected

Sterile material simple packaging

24 hours

6 weeks

Sterile material double packaging

6 weeks

6 months

Sterile material storage packaging

Storage conditions: • Temperature 15 – 26 ° C • Air humidity 30 – 40% • Air pressure, normal atmospheric pressure

5 years

Various container loads, storage periods and storage conditions have to be validated by the responsible specialist hygiene personnel. The sterilisation containers are suitable for sterilisation processes using hot steam according to DIN 58946-1: • Fractionated vacuum processes • pre-vacuum processes • Fractionated flow processes Please take other details from our product catalogues. 3 • • •

Processes which are not to be used Hot-air sterilisation Formaldehyde or ethylene oxide sterilisation Substitute processes for the sterilisation of thermo-labile materials such as plasma or peroxide sterilisation

4 Handling The sterilisation containers may only be handled by personnel who have been instructed and trained in their use, in order to prevent damage to the containers, fasteners, seals and sterile filters. The sterilisation containers are also supplied with coloured lids. Allocation to various medical disciplines and specialist departments can thus be simplified using different colours. Coloured identification tags provide information about the contents and location for their use. The fastener can be provided with a security seal, which has to be broken when opening. Only an intact security seal ensures that the sterilisation container has not been opened without pRolansion. The filter holder has to be pressed into place after inserting the filter such that it is heard to snap into position. Filters may only be used together with the ROLAN filter holder. 5 Loading 5.1 Loading with instruments The overall weight for loading 1/1 containers should not exceed 10 kg (DIN 58953-9), as otherwise satisfactory sterilisation of sterile materials cannot be ensured. 1/2 containers should be loaded with maximum 5 kg sterile materials. For smaller containers, a correspondingly smaller loading weight should be chosen. 5.2 Loading with textiles A maximum loading of 8 kg is permitted for textiles. Pay attention that the folded textile or laundry articles are horizontal. In the case of a full container, it should be possible to push an outstretched hand without effort between the pieces of laundry (DIN 58953-9). PRECAUTION! The sterilization of various container loads and packaging configurations has to be validated by the responsible specialist hygiene personnel according ISO 11134 6 Placement in the sterilizer The sterilisation containers are constructed so that they can be used in any conventional large sterilizer for sterilisation with moist heat. Pay attention that heavy containers are placed at the bottom of the sterilisation chamber. Thanks to the way they are constructed, the sterilisation containers can be stacked safely and without a problem on top of one another during sterilisation without slipping out of place (DIN EN 868-8). The loading instructions of the sterilizer manufacturer should be observed. 7 Storage Thanks to the way they are constructed, the sterilisation containers can be stacked safely on top of one another without a problem during sterilisation and without slipping out of place. Protect the sterilisation containers and hence the sterile material from damage, dirt, moisture and large temperature variations (build-up of condensation).

Instructions for Use · Sterile Container Systems 8 Maintenance / Repair • The useful life of undamaged cover seals is at least 500 sterilisation cycles. The cover seals then have to be replaced. • Cover seals have to be exchanged if they show signs of damage. • Cover seals should not be treated with spray, oil or solvents. For cleaning and maintenance simply wipe off occasionally with a damp cloth. • If any damage is noticed to the sterilisation containers, this has to be repaired. • Maintenance and repair of sterilisation containers may only be carried out by qualified persons. Do not attempt to carry out repairs on the cover seals or fasteners yourself, in order not to jeopardise the safety in use of the container. • Sterilisation containers can be sent to ROLAN or one of the authorised repair services for maintenance and repairs.

10 Safety

• Replacement parts can be obtained from ROLAN:

The sterility of the products to be sterilized can also be achieved with other sterilisation processes without a problem. However, these procedures also have to be validated, if required, in a separate process. In addition, the sterilisation containers were checked with a defined and controlled process as well as for bacterial growth. It was possible to confirm the sterility of the medium batch used. The respective expert report can be obtained from us upon request.

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Paper filter holders

- Textile filter holders

Lid cover seals Disposable paper filters (100’s) for 1/1 containers, 3/4 containers, - 1/2 containers and flat containers - Disposable paper filters (100’s) for mini-containers - Disposable paper filters (100’s) for dental containers - Identification labels

-

Plastic Security seal (100’s)

50-1809.00 50-1809.01 50-1853.00 50-1800.00 50-1802.00 50-1804.00 50-1820.00 to 50-1820.08 50-1819.00

9 Materials Sterilisation containers are made of anodised aluminium alloy and their accessories of surgical stainless steel.

Tests / examinations 10.1 The following norms were taken into consideration in order to ensure the safety of sterilisation containers in manufacture and handling: In order to ensure sterile safety, tests were carried out by an independent and accredited test laboratory. The purpose of these trials was to validate a sterilisation process for the reusable ROLAN sterilisation container with moist heat. On the basis of the results, we therefore recommend the following sterilisation process: Recommended sterilisation parameters: 134 °C ± 1.0 °C; low-vacuum, sterilisation time 5 minutes

10.2 Special remarks Please observe the following in order to ensure perfect functioning of the sterilisation containers: • Never pierce the sterile filter! • Avoid improper stacking • Avoid laying pointed and sharp objects onto the sterilisation containers Prevent the penetration of organisms by avoiding:

• Spillage of contaminated, cleaning or disinfecting solutions • Penetration of contaminated external condensation (e.g. caused by spaces when stacking hot containers)

DIN EN 868-1

Packaging materials and systems for medical devices to be sterilized – Part 1: General requirements and test procedures

DIN EN 868-2

Packaging materials and systems for medical devices to be sterilized – Part 2: Sterilizing packaging; requirements and test procedures

DIN EN 868-8

Packaging materials and systems for medical devices to be sterilized – Part 8: Reusable sterilisation containers for steam sterilizers according to EN 285; requirements and test procedures

• Rubbing dust and dirt into the filter when wiping off the containers • Long-term storage 11 Cleaning and disinfection 11.1

Requirements according to DIN 58953-9

• The operators have to specify by means of a disinfection and cleaning plan, when and how the sterilisation containers have to be cleaned and/ or disinfected. • Containers used for waste disposal have to be cleaned and disinfected each time after use. 11.2

Manual cleaning

• Only use neutral cleaners or neutral cleaners and disinfectants for cleaning.

• Only use neutral cleaners with aluminium containers, which have been

(Draft norm) ISO 11607-1

Packaging materials and systems for medical devices to be sterilized – Part 1: Requirements placed on materials, sterile barrier systems and packaging systems

expressly approved by the manufacturer for the cleaning of aluminium containers. • After cleaning, careful rinsing out and manual drying is necessary. • Do not use metal brushes or scouring agents.

DIN 58952-2

Sterilisation; Packaging for materials to be sterilized, metal sterilizing baskets

• Mechanical cleaning of the containers is to be preferred to manual

DIN 58952-3

Sterilisation; Packaging for materials to be sterilized, metal sterilizing trays

• Machine cleaning of the containers is only recommended if the washing

DIN 58953-9

Supply of sterile materials; Applied technology for sterilizable containers

ISO 14937

Sterilisation of products for preventive medicine – General requirements placed on the characterisation of a sterilizing agent and on the development, validation and routine monitoring of a sterilisation procedure for medical devices

ISO 11134

11.3

Mechanical cleaning

cleaning

• • •

Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization

• •

machine has a special washing programme for aluminium containers. When machine cleaning the containers, it is absolutely essential to observe the special specifications of the washing machine manufacturer and their instructions for the cleaning of containers. Only use neutral cleaners or neutral cleaners and disinfectants for cleaning. Do not use any cleaning solutions containing soda or caustic soda No additional use of acidic neutralizers Use neutral cleaners only with aluminium containers, which have been expressly approved by the manufacturer for the cleaning of aluminium containers. The exact dose of the cleaner is to be used as specified by the manufacturing company. With an optimisation of the program these products are also suitable for cleaning surgical instruments Fully demineralised water has to be used for final rinsing, as the salts in the water during the subsequent sterilisation can also lead to spotting The cleaning plant has to be designed for the cleaning of sterilisation containers. This applies in particular to ensure secure placement in the wash baskets and the arrangement of the spray jets or arms.

• Contamination which cannot be removed in a normal cleaning cycle independent of the process (sticky labels, indicator strips, writing), can be removed with anodic cleaners. After this special treatment, the containers should be cleaned as usual • As a matter of principle, remove the lids before cleaning the containers. The filter holders should be removed and cleaned individually together with the pans and lids. 12 Accessories 12.1

Filters

• Disposable paper sterile filters. Have to be exchanged before every new sterilisation cycle.

• Suitability and exactness of fit can only be ensured by using ROLAN filters.

• Guarantee can only be accepted when original ROLAN filters have been used.

12.2 Sterilisation textile cloths (wrapping cloth) Textile cloths (wrapping cloths) can be used with almost every kind of sterile material. They are suitable for sterilisation, but not for longer storage periods (max. 24 h) and only for short-term, protected transport. 12.3

Other accessories

PRECAUTION! Small baskets, trays, other types of accessories, especially with cover or lids, should only be used with the sterilization container, if the sterilization container has been specifically designed and tested for that purpose. Please see details about ROLAN frames, baskets, metal sterilizing trays... in our product catalogue. WARNING! Only filters, seals and sterile packaging from the ROLAN Company should be used or filters, seals and sterile packaging which are approved by ROLAN. WARNING! When using non-absorbent tray liners (e.g., plastic/silicone-fingered organizing mats) for the containers this can cause condensate to pool. Instead of this use moisture-absorbing mats if necessary. 13 Warranty These sterilisation containers have been manufactured from high quality materials and have been subjected to quality control checks before release to the market. Nevertheless, revert to the above-mentioned address in case any errors should arise. The warranty shall lapse if repairs are carried out by companies who are not authorised for repairs by ROLAN. THE ROLAN COMPANY ACCEPTS NO LIABILITY IN DEMONSTRABLE CASES OF VIOLATION OF THIS CUSTOMER INFORMATION.