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Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite Gebrauchsanweisung CleanLoop_EN B 11.05.213 jw sw jw 1 von 12

Instructions for use

CleanLoopTM Sterilization Container

Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: [email protected]

Inhalt 1. Product Description of CleanLoopTM (See Illustrations) 2

2. General Information 3

3. Warranty 4

4. Intended Use 4

5. Preparation / Initial Use 4

6. Handling Instructions / Design & Functions 4

6.1. Closing and Opening the Container 4

6.2. Silicone Gasket Installed in Lid 5

6.3. Filter System 5

6.4. Log Labels / Indicator Cards 6

6.5. Coding 6

6.6. Sealing 6

7. Loading the Container 6

7.1. Pre-Loading Checks 6

7.2. Loading Instruments 7

8. Loading and Unloading the Sterilizer 7

8.1. Sterilization 7

9. Storing the Containers with Sterile Supplies 8

10. Checking the Container and Placing the Sterile Supplies Ready for Use 8

11. Cleaning, Disinfection and Care 8

11.1. Notice Regarding the Materials Used 8

11.2. Manual Processing 9


11.3. Machine Processing 9

12. Maintenance 10

12.1. Replacing the Gasket 10

12.2. Maintenance Schedule 11

13. Safety Instructions 11

14. Spare Parts 11

15. Reference Standards 12

16. Information Provided by the Manufacturer Pursuant to EN 868-8-4.7 12

1. Product Description of CleanLoopTM (See Illustrations)

1. Container lid 8. Safety cover

2. Container box 6. Closure

5. Lateral

fittings

9. Log labels /

Indicator cards 10. Coding /

data chip

11. Seal

socket

7. Carrying

handle


2. General Information

Thank you for your decision to buy a product made by Geister Medizintechnik GmbH. This product bears the CE-mark, which means that it satisfies the essential requirements laid out in the EU Directive 93/42/EEC concerning medical devices (MDD). Manufacturer: Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49 7461 96624-0 FAX: +49 7461 96624-22 E-Mail: [email protected] Internet: www.geister.com Be sure to observe the applicable general guidelines and hygiene requirements when handling contaminated goods, goods to be sterilized and sterile supplies! To prevent any recontamination, always follow the instructions provided herein. The service life of the container and its gaskets meets the requirements of EN 868, Part 8.

4. Lid gasket 3. Filter system /

labyrinth disk


Only trained personnel is permitted to use the containers!

3. Warranty

The manufacturer will not assume any responsibility for direct and/or consequential damage caused by improper use, especially improper cleaning. Our Standard Terms of Business as updated from time to time shall apply.

4. Intended Use

The reusable CleanLoopTM sterilization container is intended for packaging, sterilizing, transporting and storing sterile supplies and placing them ready for use in sterile condition. All container versions, including all components, meet the requirements of applicable national and international standards relating to sterile barrier systems and packaging systems. 5. Preparation / Initial Use

The container must be cleaned (see section 11) before loading and sterilizing it for the first time. For container assembly, see section 6. The functional check must be performed as described in section 6.1.

6. Handling Instructions / Design & Functions

6.1. Closing and Opening the Container

Closing: Place the lid (1) on the box (2), then press it in place from above and lock it with the lateral closures (6) located above the seal sockets (11). You can feel and hear the lock engage if done properly. Opening: Upon opening the two closures (6), the lid can be lifted off the box. Please note that both sides must be unlocked and opened completely before the lid can be removed. Lifting the lid on one side only could destroy the closures!


6.2. Silicone Gasket Installed in Lid

The inner side of the lid features an all-around silicone gasket (4) that ensures a germ-tight fit between the lid and the box. The gasket (4) must be replaced as specified by the relevant standard (DIN 58953-1). It is installed so that it is easily accessible for cleaning.

6.3. Filter System

In our filterless system, the labyrinth is firmly integrated into the lid. The labyrinth disk is mounted by simply screwing it into the bayonet lock until it locks home. Note, however, that you need to press the disk slightly downwards during this process. The direction of rotation for opening/closing the labyrinth disk is indicated on the disk. The labyrinth disk (3) must be properly inserted prior to each sterilization cycle. No additional paper filter is required with this system. Do not use any paper filter in addition!

6

Press


6.4. Log Labels / Indicator Cards

On both sides of the container, the lateral fittings (5) feature an integrated field (9) for inserting and fixing universal log labels.

6.5. Coding

On both sides of the container, the lateral fittings (5) feature two integrated fields intended for coding labels (10). It is also possible to insert a data chip into these fields. The coding label (10) can be laser-lettered by the manufacturer according to the user’s specifications (tray content, destination).

6.6. Sealing

The lateral fittings (5) feature an integrated socket for a disposable seal (11) that visualizes any unauthorized or accidental opening of the container after sterilization (EN 868-8-4.2.3). The seal must be destroyed and removed to open the closures.

7. Loading the Container

When loading the container, a clearance of at least 10 mm must be maintained below the filter system (3) to ensure a uniform distribution of the steam streaming into the container. 7.1. Pre-Loading Checks

Prior to use, all components of the container must be visually inspected for potential damage and proper functioning. The labyrinth disk must be properly inserted (see section 6.3). Defective components must be replaced or repaired. The gasket installed in the lid must be fully intact without any visible damage, or else it must be replaced. Only components from Geister Medizintechnik GmbH are permitted for use when making replacements or repairs.


7.2. Loading Instruments

We recommend you to sterilize and store your instruments on system-compatible trays, wrapping them with a material suitable for the internal (secondary) packaging of sterile supplies. Please note the recommendations of the DIN EN 868-8 and DIN 58953-9 standards regarding maximum container loads. If additional soft packaging is used for internal packaging, make sure that the wrap fits tightly (e.g. using adhesive tape) so as to prevent the material from being sucked against the labyrinth disk during vacuum generation. Note that if the safety distance is not maintained, sterility is no longer guaranteed and irreparable deformation of the container box will be caused in most cases. 8. Loading and Unloading the Sterilizer

Loading: Be sure to observe the instructions provided by the manufacturer of the sterilizer. The containers can be stacked on top of each other during sterilization as well as storage (heavy containers should always be placed at the bottom). A clearance of at least 1 cm should be maintained between containers and/or other sterilizer equipment. WARNING: Do not additionally package or cover the container inside the sterilizer! To ensure proper steam exchange, it is important to take care that the labyrinth system is not covered or obstructed in any way, neither internally nor externally. Unloading: To transport the container, always use the carrying handles (7). Danger of burns! The container is hot after sterilization! Be sure to wear protective gloves!

8.1. Sterilization

The products of the CleanLoopTM series are suitable for steam sterilization using a fractionated pre-vacuum / Pulsing Vacuum (Pre-Vac) method. A validated, fractionated steam sterilization method must be used for sterilization (e.g. in a sterilizer complying with DIN EN 285:2006+A2: 2009 (German version) and DIN EN 13060:2004+A2:2010, validated according to DIN EN ISO 17665, Part 1:2006). Do not use any other sterilization method!


The contents of the sterilization container can be considered sterile only if the container has been properly sterilized, the lid is locked, the filter system has been properly installed, the closure seals are undamaged (to be verified by visual inspection), and all container components are fully intact. 9. Storing the Containers with Sterile Supplies

The containers must be protected against dust, humidity and damage during storage. The storage conditions and storage time must comply with DIN 58953-9 requirements. It is the responsibility of the operator to determine the storage period and ensure adequate storage conditions and storage times. 10. Checking the Container and Placing the Sterile Supplies Ready

for Use

Before opening the container, verify that the seal is in place and intact. The container can only be opened after the seal has been destroyed and removed (see section 6.6). If the seal or the container itself is found to be damaged, it must be assumed that the contents are no longer sterile. In such case, the supplies must be reprocessed prior to use. 11. Cleaning, Disinfection and Care

In selecting the treatment agents to be used, make sure that they are compatible with the container components and that their hygienic and microbiological effectiveness is guaranteed. Thorough rinsing with demineralized water is essential to ensure that no cleaning and care agent residues are left on the container components.

The container lid (1), the container box (2) and the labyrinth disk (3) must be separated from each other before starting the cleaning process!

11.1. Notice Regarding the Materials Used

The container lid (1), the container box (2), the labyrinth disk (3) and the lateral fittings (5) are made of anodized aluminum. Thanks to their anodized surfaces, the various parts offer more resistance to abrasion and wear. It is essential to make sure that the detergents and disinfectants used for cleaning are products approved by the manufacturer (e.g. Dr. Weigert) for use on anodized aluminum. Be sure also to


observe the dosing instructions provided by manufacturer of the detergents/disinfectants used, as well as the instructions provided by the manufacturer of your washer-disinfector. Notice: Even the use of a mildly alkaline detergent/disinfectant can lead to discoloration of the anodic coating of the lid. However, this has no adverse effect on function at all. WARNING: Using unsuitable cleaners and disinfectants is likely to destroy the anodic coating!

11.2. Manual Processing

All accessible parts can be cleaned with a neutral-pH, surfactant-based detergent (neutral cleaner) or with a detergent recommended by the manufacturer for use on anodized aluminum. Visible dirt should be removed under running water using a soft brush (do not use metal brushes or scouring agents!). For disinfection, a disinfectant recommended by the manufacturer for use on anodized aluminum must be used. The final rinse must be carried out with demineralized water.

11.3. Machine Processing

For machine cleaning, only a neutral-pH detergent or a detergent expressly approved by the manufacturer for cleaning anodized aluminum surfaces should be used. The final rinse must always be carried out with demineralized water. Be sure to observe the instructions provided by the manufacturer of your washer-disinfector and the manufacturer(s) of the treatment agents used. The cleaning system used must be suitable for cleaning containers. This applies in particular to safe container storage inside the cleaning baskets and adequate arrangement of the spray nozzles or arms. The lid (1) and the labyrinth disks (3) must be cleaned in a tilted position, with the integrated labyrinth pointing downwards. The container box (2) must be placed upside down (opening pointing downwards).


12. Maintenance

Repairs and/or servicing work may only be carried out by authorized personnel and in accordance with these Instructions for Use. If parts are repaired that could affect the germ tightness of the container, a careful visual inspection is required before putting the container back in service. Only original parts from Geister Medizintechnik GmbH may be used for repairs!

Notice: The container may only be repaired by us or a person or firm that has been expressly authorized by us to perform such work. If the repair is done by a duly authorized person or firm, the operator of the container is required to obtain from the repairer a certificate with details on the nature and scope of the repair work done. This certificate must show the name and address of the firm and must be dated and signed. Moreover, repaired containers or container parts must be additionally marked with the repairer’s ID label in all cases where the repair has not been performed by the container manufacturer itself.

12.1. Replacing the Gasket

The gasket (4) must be replaced as specified in the relevant standard (DIN 58953-1). Please have this done by an authorized person, or send the lid of the container (1) to the following address: Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen /Germany


12.2. Maintenance Schedule

Depending on the conditions of use, and in accordance with EN 868-8, we recommend carrying out the following maintenance steps after every 100 usage cycles or once a year:

Container lid (1) Visual inspection for damage

Replace lid

Container box (2) Visual inspection for damage and deformation

Repair or replace

EasyStop filter system / labyrinth disk (3)

Visual inspection for damage, functional check of closures and locking mechanisms

Replace labyrinth disk or lid

Lid gasket (4)

every 100 cycles Visual inspection for damage and functional check for elasticity (following max. compression, the gasket must return to its initial position)

Replace gasket

Closures (6) Visual inspection for damage and functional check (see 6.1)

Repair

13. Safety Instructions

Use only the carrying handles (7) to lift or carry the containers. To prevent hazards and material damage caused by containers falling down accidentally, suitable equipment must always be used for transporting and storing the containers. Moreover, care should be taken to stack the containers no higher than 50 cm. As regards the goods to be sterilized, follow the instructions provided by the manufacturer of the respective product. 14. Spare Parts

A list of spare parts (including the item numbers) is provided by Geister Medizintechnik GmbH. Only original parts from Geister Medizintechnik GmbH may be used!


15. Reference Standards

DIN EN 285, DIN EN ISO 17665 Part 1, DIN EN 868 Part 8, DIN EN ISO 11607 Part 1 and Part 2, DIN 58953 Parts 1+9, MPG (German Medical Devices Act), DIN EN ISO 13485, DIN EN ISO 14971 (Medical devices), DIN EN 1041 (Information supplied by the manufacturer of medical devices), DIN EN 980 / DIN EN ISO 15223-1 (Symbols for use in the labeling of medical devices), DIN EN ISO 17664 (Sterilization of medical devices), ANSI AAMI St 77, DIN EN ISO 25424 (Sterilization of medical devices), CE marking acc. to Directive 93/42/EEC (MDD). 16. Information Provided by the Manufacturer Pursuant to EN 868-

8-4.7

Specification of essential components: see section 6, “Handling Instructions / Design and Functions”, and section 1, “Product Description”. Checks, maintenance and/or replacements: see sections 2, 5, 12 and 14. Service life of the sterilization container (usage cycles) acc. to EN 868-8-4.4.1 Service life of the gaskets acc. to EN 868-8-4.4.1 Cleaning procedure: see section 11, “Cleaning, Disinfection and Care”.

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