Sterile container system

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AESCULAP Aicon® Sterile container system Legend

8.5.1

1 Lid 2 Lid lock 3 Perforation field cover 4 Plastic seal 5 Single-use/permanent filter 6 (Universal) filter holder 7 Bottom 8 Front panel 9 Holding clamp for front plate 10 Indicator plate holder 11 Signs for front plate 12 Condensate discharges (2 pcs) 13 Pushbutton 14 Lid seal

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About this document... Scope... Warnings... Product description... Areas of use and limitations of use... Intended use... Indications... Risks, adverse effects and interactions... Safety notes... General safety information... Sterility... Limitations on reuse... First use... Working with the device... System set-up... Remove container lid... Changing the filters in lid and bottom... Function checks... Applications... Loading the sterile containers... Labeling and sealing the container... Loading the sterilizer... Sterilization... Unloading the sterilizer and releasing the sterile goods... Transporting the sterile container... Storing the sterile containers... Checking and commissioning the sterile materials... Troubleshooting list... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparing for cleaning... Cleaning/disinfection...

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About this document

8.6 8.6.1 8.7 8.7.1

Contents 1. 1.1 1.2 2. 3. 3.1 3.2 4. 5. 5.1 5.2 5.3 6. 7. 7.1 7.1.1 7.1.2 7.2 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.3.8 7.4 8. 8.1 8.2 8.3 8.4 8.5

8.8 9. 9.1 9.2 10. 11. 11.1

Product-specific safety instructions for the reprocessing procedure... Manual cleaning/disinfecting... Manual cleaning with disinfecting cleaning by wipe disinfection... Mechanical cleaning/disinfecting... Mechanical neutral or mild alkaline cleaning and thermal disinfecting... Care... Maintenance and Service... Technical Service... Service addresses... Disposal... Extracts from relevant standards... Standards cited...

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These instructions for use describe important application and care instructions and provide – without claim to completeness – warning notices of possible dangers that can arise from non-observance. Note General risk factors associated with surgical procedures are not described in this documentation.

1.1

Scope

These instructions for use apply to all the components of the AESCULAP Aicon Sterile Container System. ► For article specific instructions for use and information on processing and material compatibility,: see also Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings make clear the dangers to patient, user and/or product that could arise during the use of the product. Warnings are labeled as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. If it is not prevented, minor or moderate injuries may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

en 2.

Product description

The Aesculap sterile container system meets the requirements of EN ISO 11607 Part 1. ■ Sterile containers with a perforated lid and a solid bottom are suitable for steam sterilization in a sterilizer according to EN 285 using the fractionated vacuum process. Hot air sterilization, gravitation or flow processes and formaldehyde or ethylene oxide sterilization or substitute procedures for the sterilization of thermolabile products, such as plasma or peroxide sterilization, are not applicable. Note The suitability of any specific process must be validated at the site of application. To accelerate drying in the sterilizer, the AESCULAP Aicon Sterile Container System can optionally be equipped with 2 condensate drains JJ800 . For this purpose, separate container bodies are required. Note In the case of container bottoms with condensate discharges, the last digit of the item number is always a "1," e.g. JJ121.

5.

Safety notes

5.1

General safety information

► Prior to use of the product, check that the product is in good working

order, see Chapter 7.2. ► To prevent damage caused by improper setup or use and in order not to

compromise the warranty and liability: – Use the product only according to these instructions for use. – Please observe the safety information and maintenance notes. – Never use damaged or faulty sterile containers. – Replace any damaged components immediately with original spare parts. ► Ensure that only persons with the requisite training, expertise or experience will handle the product and its accessories. ► Keep the instructions for use accessible for the users. ► Follow general guidelines and aseptic principles when handling contaminated items that have undergone or are to undergo sterilization. Note The user agrees to report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

Required components

■ Bottom (e.g. JJ110) ■ Lid (e.g. JJ410) ■ Filter retainer (JJ600) ■ Plastic seal (JJ700) ■ Filter (e.g. JJ612)

Contamination of sterile materials The sealing of the sterile container and its germ barrier function will be compromised if the sterile container is combined with components from other manufacturers. ► Combine only AESCULAP Aicon sterile container products.

5.2

3.

Areas of use and limitations of use

3.1

Intended use

The Aesculap sterile container systems is a multi-use sterilization container. It is used as a sterile goods package to hold surgical instruments and/or textiles during vacuum steam sterilization and to maintain sterility during storage and transport under appropriate hospital conditions in health care facilities. Intended users are professionals trained in health care, especially in the fields of hospital hygiene and the processing of medical devices, or assistants working under the guidance and supervision of the former.

3.2

Indications

The Aesculap sterile container system has no clinical indication, but rather only the aforementioned intended use. No contraindications are known.

4.

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

5.3

Limitations on reuse

There are no known effects of processing resulting in damage to the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product, see Chapter 7.2.

6.

First use

► Thoroughly clean the new sterile container prior to first use. ► After cleaning, use a suitable filter, see Chapter 7.1.

Risks, adverse effects and interactions

No risks, adverse effects and interactions can currently be identified.

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en 7.

Working with the device

7.1

System set-up

Note Use an appropriate filter from Aesculap for the sterilization process. 7.1.1 Remove container lid ► Pull both lid closures 2 on the top side of the lid 1 upward. ► Remove lid 1 from the bottom 7. ► Put lid 1 down and push lid closures 2 down to the stop. 7.1.2 Changing the filters in lid and bottom Replace single use filter before every sterilization: ► Press the push buttons 13 on the universal filter retainer 6 simultaneously, see Fig. A. ► Remove the universal filter retainer 6. ► Insert a new filter 5 and remount the universal filter retainer 6. ► Press filter retainer 6 until locking catches can be heard to latch in place.

7.2

Function checks

► Visually inspect all components of the sterile containers for damage

and correct functioning prior to each use. Check that: – Metal parts are not deformed – The aluminum lid and bottom are not warped – Plastic parts are not damaged – Lid seals 14 are intact – The seal at filter retainer 6 is intact (no cracks) – The edges of the filter retainer 6 are seated in full-surface contact – The filter retainer 6 latch functions properly (engages) – The single use filter 5 has been changed – The single use filter 5 is not damaged (no kinks, holes, cracks) – The lid closure 2 is functional (grips under bottom edge) – In containers with condensate outlet: condensate outlet 12 is present and undamaged ► Use sterile containers only if they have been visually inspected and are

free from defects listed above. Replace any damaged components immediately with original spare parts, or have the damaged components repaired, see Chapter 9.1.

7.3

Applications

WARNING Risk of contamination of sterile goods by sterile containers that have not passed the function check! The sealing of the sterile container and its germ barrier function will be compromised if the sterile container is combined with components from other manufacturers. ► Only combine AESCULAP Aicon sterile container accessories/spare parts. CAUTION Risk of non-sterility of container contents! ► Never carry or lift the sterile container at the lid.

7.3.1 Loading the sterile containers According to DIN EN868-8 and DIN 58953-9, the following maximum load of the sterile container (including wire basket) must be observed: ■ Loading weight – 1/1 container: 10.0 kg – 1/2 container: 5.0 kg – 3/4 container: 7.5 kg ■ Maximum load height: up to about 1 cm below the edge of the container bottom. Note Store sterile goods in wire baskets in suitable supports. When doing so, lay hollow materials, dishes, plates, etc with the opening facing downwards at a slant. Note Load the sterile container in such a way that filter retainer 6 is not obstructed. ► Pull both lid closures 2 on the top side of the lid 1 upward and place

lid 1 on bottom 7, see Fig. B. ► Push both lid closures 2 down to the stop in order to lock the lid 1 on

the bottom 7, see Fig. B. ► Ensure that both lid closures 2 audibly lock in place. If not: have the

sterile container repaired, see Chapter 9.1. 7.3.2 Labeling and sealing the container ► After loading the sterile container: label container on the end faces. Note A front plate (e.g. JJ500) can also optionally be used to label the sterile container. ► When using a front plate 8:

– Snap in indicator sign holder 10, signs 11 and/or holding clamp 9 in front plate and/or insert labels in holder. – Snap front plate 8 in recesses on the end faces. ► After closing the sterile container, insert a plastic seal 4 (e.g. JJ700) at

on the lid closure 2, see Fig. C. Note An indicator suitable for the sterilization process (Type 1 in accordance with EN ISO 11140-1) must be used! 7.3.3 Loading the sterilizer Prepare the sterile container and the sterilizer in the following way for loading the sterilizer: WARNING Risk of vacuum damage to the sterile container due to inadequate pressure equalization! ► Do not use outer packaging for the sterile containers. ► Never obstruct air flow through the perforation fields in the lid. ► Do not place foil packaging directly on the sterile container. Note The AESCULAP Aicon Sterile Container System can be sterilized with the perforation field cover JJ440 fitted. ► Follow the sterilizer manufacturer’s recommendations. ► Always place heavy sterile containers at the bottom of the sterilizer.

Note AESCULAP Aicon sterile containers can be stacked in the sterilizer. 4

en 7.3.4

Sterilization

CAUTION Risk of sterilization failure! ► Sterilize the containers only by approved and validated sterilizing processes. ► Sterilizing with steam: sterilization must be performed by means of a

validated steam sterilization process (e.g. in a sterilizer according to EN 285 and validated according to ANSI/AAMI/ISO 17665-1). ► Ensure that the maximum load capacity of the steam sterilizer, as spec-

ified by the manufacturer, is not exceeded. ► Ensure that the sterilization medium can reach all products stored in the sterile container. Note A product cooling time of 30 minutes outside of the sterilizer is recommended after sterilization. 7.3.5

Unloading the sterilizer and releasing the sterile goods

DANGER Risk of contamination from improperly sterilized materials! ► Prior to commissioning the sterile materials, check to ensure that the sterilization was successful. WARNING Risk of burns due to a hot sterile container after sterilization! ► Allow sterile containers to cool after sterilization. ► Make certain that the color of the indicator point has changed. ► Ensure that the plastic seal 4 is intact.

7.3.6

Transporting the sterile container

CAUTION Risk of non-sterility of container contents! ► Never carry or lift the sterile container at the lid. ► Transport the sterile container in such a way that mechanical damage will not occur. 7.3.7 Storing the sterile containers Note The sterile containers may be stored in stacks. ► Store sterile containers in a dry, clean and protected place.

The loss of sterility is normally event-based and not time-based. Loss of sterility is not so much connected to the storage periods as to outside influences and the effects of storage, transport and handling. Therefore, blanket statements cannot be made regarding appropriate storage periods, see EN ISO 11607-1. 7.3.8 Checking and commissioning the sterile materials The contents of a sterile container can only be considered to be sterile if the sterile container is sterilized, stored and transported as specified, and opened under aseptic conditions (operating room). ► Verify that the indicator colour has changed. ► Ensure that all container components are intact, particularly: – Plastic seal 4 – Single-use filter 5 – Lid seal 14 If this is not the case, the sterile materials must be processed again.

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en 7.4

Troubleshooting list

Malfunction

Cause

Excessive amounts of condensate inside the sterile container

Temperature of sterile materials too low prior to ster- Allow materials for sterilization to reach room temperailization ture (approx. 20 °C) Sterile container too heavy

Remedy

1/1 container: with instruments: max. load 10.0 kg 1/2 container: max. load 5.0 kg 3/4 container: max. load 7.5 kg

Materials for sterilization incorrectly packed

Position hollow materials, dishes, plates, etc with the opening facing downwards at a slant.

Sterile container incorrectly positioned in sterilizer

Always place heavy sterile containers at the bottom. Place sterile container with condensate outlet in sterilizer horizontally. Sterilization rack should not have any slope.

Sterile containers processed immediately after steril- Allow sterile containers to cool down to room temperaization ture prior to processing. Sterile containers improperly positioned during cool- Do not store sterile containers on a floor or in a drafty ing phase place. Store sterile containers in a temperature-controlled room with a constant relative humidity and temperature. Sterilizer properties do not comply with DIN EN 285

Have sterilizer serviced regularly. Check drying vacuum. Check drying time. Check steam quality and upgrade if necessary.

Condensate on the lid

Empty-cycle and vacuum test not run daily before sterilization begins

Run empty-cycle and vacuum test daily before beginning sterilization.

Unsuitable sterilizer cycle selected

Select cycle in accordance with load.

Sterilizer door left open too long, sterilizer cooled down

Load and unload sterilizer quickly.

Incorrect loading configuration

Loading configuration according to validation and loading specifications.

Sterilizer properties do not comply with DIN EN 285

Have sterilizer serviced regularly. Check drying vacuum. Check drying time. Check steam quality and upgrade if necessary.

No clear color change of indicator Sterilization performed incorrectly (type 1 according to EN ISO 11140-1) Sterilizer defective

Sterile containers deformed

Container lid cannot be positioned or locked on the bottom component

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Have the sterilizer inspected by the manufacturer.

Accessory with indicator stored incorrectly

Observe storage conditions as specified on the packaging of the accessory.

Expiration date of accessory with indicator passed

Repeat sterilization with new accessory with indicator.

Sterile container stored improperly

Do not store sterile container that has been sterilized with steam in the immediate vicinity of sterile materials that have been sterilized with H2O2.

Perforations covered during sterilization

Do not cover the perforation field from either the inside or the outside.

Permissible loading height exceeded

Observe the loading heights, see Chapter 7.3.1

Container lid or bottom are deformed/damaged due to improper handling

Replace container lid or bottom, or have components repaired by Aesculap Technical Service, see Chapter 9.1.

en 8.

Validated reprocessing procedure

8.1

General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. The recommended cleaning chemical was used for validation. Due to process tolerances, the manufacturer's specifications can only serve as an approximate guide for assessing the processing procedures applied by the individual operator/processors.

8.4

Preparing for cleaning

Note For wet disposal of products, Aesculap recommends the use of waste disposal containers (e.g. JK060R).

8.5

Cleaning/disinfection

8.5.1

Product-specific safety instructions for the reprocessing procedure

CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents which – that are approved for use on materials such as aluminum, plastics and stainless steel, – do not cause stress cracks in plastics (e.g., PPSU), – do not attack softeners (e.g., in silicone) and cause brittleness. ► Observe specifications regarding concentration, temperature and exposure time.

Note For up-to-date information on reprocessing and material compatibility, see also the Aesculap extranet at eIFU.bbraun.com

8.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and reprocessing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehyde) should be used. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ In the case of aluminum, a pH value > 8 for the application solution/working solution is enough to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Only use cleaners that have been approved for sterile containers. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For detailed information on hygienically safe and materialfriendly/careful processing, please refer to www.a-k-i.org Header "AKIBrochures", "Red Brochure".

8.3

Reusable products

There are no known effects of processing resulting in damage to the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

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en 8.6

Manual cleaning/disinfecting

► Prior to manual disinfecting, allow water to drain off for a sufficient

length of time to prevent dilution of the disinfectant solution. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning/disinfection process if necessary.

8.6.1

Manual cleaning with disinfecting cleaning by wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

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Cleaning

RT (cold)

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D–W

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Dry

RT

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Wipe disinfection

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>1

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I Alcohol Denat. 70 % (Ethanol B. Braun)

II Aldehyde-free surface disinfectants (e.g. Melisptol® HBV cloths)

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Final rinse

RT (cold)

0,5

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FD–W

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Rinse off cleaning chemicals; do not leave residues

V

Dry

RT

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D–W: FD–W: RT:

Drinking water Demineralized water Room temperature

Phase I ► Clean the product under running tap water using a suitable cleaning

brush until all visible residue has been removed from the surfaces. ► Move non-rigid components, such as adjusting screws, joints, etc., dur-

ing cleaning. Phase II ► During the drying phase, dry the product using the appropriate equipment (e.g. wipes, compressed air).

Phase IV ► Rinse disinfected surfaces after the prescribed contact time (at least 1 min) under running demineralized water. ► Drain any remaining water fully. Phase V ► During the drying phase, dry the product using the appropriate equipment (e.g. wipes, compressed air).

Phase III ► Wipe all surfaces of the product using a single-use disinfecting wipe.

8.7

Mechanical cleaning/disinfecting

8.7.1 Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

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Water quality

Chemicals

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<25/77

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Cleaning

55/131

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FD–W

Neutral:

■ B. Braun Helimatic Cleaner neutral – pH neutral – Working solution 0.5 % Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant – Working solution 0.5 % Alkaline: Can be processed up to pH = 10.5 if the cleaner is approved by the manufacturer for cleaning sterile containers made of aluminum or plastic. 8

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Step

T [°C/°F]

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>10/50

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Thermal disinfection

90/194

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FD–W

Other process parameters may be feasible with agreement by the hospital hygienist.

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Dry

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According to mechanical cleaning program

D–W: FD–W:

Drinking water Demineralized water

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing. ► Repeat the cleaning/disinfection process if necessary.

Note Temperatures of up to 120 °C are permitted for machine drying with hot air.

8.8

Care

► Oil closure hinges with suitable maintenance oil (e.g. Aesculap

STERILIT® I oil spray JG600 or maintenance oil JG598).

9.

Maintenance and Service

10. Disposal

9.1

Technical Service

Note The user institution is obliged to process the product before its disposal, see Chapter 8.

WARNING Risk of injury and/or malfunction! ► Do not modify the product.

► Adhere to national regulations when disposing of or recycling the prod-

uct, its components and its packaging.

► For service and repairs, please contact your national B. Braun/Aesculap

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

9.2

Service addresses

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

11. Extracts from relevant standards 11.1 Standards cited The following standards are cited in connection with the sterile containers: ■ EN ISO 11607: Packaging for terminally sterilized medical devices – Part 1 ■ EN ISO 11140-1: Sterilization of health care products - chemical indicators - part 1: general requirements ■ ANSI/AAMI/EN ISO 17665-1: Sterilization of health care products Moist heat - Part 1 ■ EN 868-8: Packaging for terminally sterilized medical devices – Part 8 ■ EN 285: Large steam sterilizers

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