Reusable filter

en ®

AESCULAP Reusable filter 1.

About this document

1.1

Scope

These instructions for use apply to the following reusable filters: JK089 JK090 JK091 and JK092. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows:

3.

Validated reprocessing procedure

3.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeld-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/reprocessor is responsible for this.

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

Note For up-to-date information about reprocessing and material compatibility, see also B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

3.2

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The permanent filters are used as germ barriers in Aesculap sterile containers. The hydrophobic PTFE filters can be used for steam sterilization in a sterilization procedure as per DIN EN 285, in a fractionated vacuum procedure, validated according to DIN EN ISO 17665. The filters can remain in the lid during the mechanical cleaning process and are suitable for up to 1 000 sterilization and wash cycles.

2.1.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

General notes

Encrusted of fixated surgical residues can make cleaning difficult or ineffective. Therefore, no more than 6 hours should pass between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. The cleaning agents must be removed by rinsing thoroughly with demineralized water and then drying. Perform additional drying, if necessary. 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 reprocessing the product. All of the chemical manufacturer's application specifications must be strictly observed. ► Do not clean with metal brushes or other abrasives that would damage the product surface.

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

For indications, see Intended use.

3.4

2.1.3

Note Aesculap recommends mechanical cleaning in an assembled condition.

Contraindications

Product-specific safety information on the reprocessing method

No known contraindications.

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures The medical professional will make decisions on concrete applicability based on the warranted properties and technical data.

2.2.2

Sterility

When cleaning in a disassembled condition: ► Ensure that when removing the round filter JK090, the perforation in the center of the filter is not damaged. ► Ensure that the filter is not damaged during cleaning, such as by instruments that are cleaned along with it. ► Wash the filter in a disassembled condition separately.

3.5

Manual cleaning/disinfection

CAUTION Risk of damage from manual cleaning! ► Clean the product as far as possible mechanically and in an assembled condition. ► Use only the cleaning agents for instruments and sterile containers used in the hospital. ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process or, if necessary, machine the reusable filter.

3.5.1

Manual cleaning and wipe disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

RT (cold)

-

-

D–W

-

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

II

Drying

RT

-

-

-

-

2.3

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD–W

-

V

Drying

RT

-

-

-

-

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the reusable filter for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. ► Secure the permanent filter in the sterile container using the appropriate filter holder. ► For round reusable filters (JK090) check for the correct filter holder (TE674/JK100). ► Ensure that the filter is not kinked when it is inserted. ► On first use of the filter, write the start and end of the usage period (equivalent to 1 000 cycles) with a suitable

marker pen on the label tab.

Fig. 1

Write the start of use

DW: FD–W: RT:

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature

Phase I ► Clean the product under running tap water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air),. Phase III ► Wipe all surfaces of the product with a single-use disinfecting wipe.

Fig. 2

Write the end of use

► At the end of the usage period, change the filter.

Phase IV ► Rinse disinfected surfaces under running demineralized water after the specified contact time has elapsed (at least 1 min). ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air),.

3.6

Mechanical cleaning/disinfection

3.6.1

Mechanical neutral or mild-alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

I

Pre-rinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemistry

3

D–W

–

10

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: Reprocessing is possible up to pH 10.5, provided the cleaning agent is manufacturer-approved for cleaning aluminum or plastic sterile containers. III

Intermediate rinse

>10/50

1

FD–W

–

IV

Thermal disinfection

90/194

5

FD–W

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

V

Drying

-

-

-

According to mechanical cleaning program

DW: FD–W:

Drinking water Fully desalinated (demineralized) water

► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfection process if necessary.

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

3.7

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.7.1

Visual inspection

► Remove the reusable filter. ► Ensure that all contamination has been removed. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. cracked, worn and severely scratched components. ► Check the product for missing or faded labels. ► Set aside the product if it is damaged.

3.7.2

Functional test

► Check for compatibility with associated products. ► Set aside the product if it is damaged.

3.8

Steam sterilization

► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA013138

2021-01

V6

Change No. 63662