ECCOS – Holder system for processing of motor components

4.

Product description

Aesculap ECCOS Holder system for processing of motor components

4.1

Components required for operation

Legend

The storage system has been designed to cover critical openings and to ensure immediate drainage of fluids that might enter the components to be able to be cleaned. For some products the holders are equipped with a flushing port for flushing as part of the washing process. The individual supports can be individually mounted and secured to the sterilizer tray by means of bolts and nuts. There are sets in which all required supports for the individual machines are pre-assembled. With their rounded screw heads, the holder system is suitable for soft wrappings as well.

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1 2 3 4

Example of an unpopulated ECCOS holder Example of a populated ECCOS holder Installation ECCOS holder in tray (nut SW10) Installation ECCOS holder in tray (nut SW7)

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use.

The installation kit GB459R and the socket key JJ589R are required to install the holder system in the sterilizer tray.

4.2

Operating principle

5.

Working with the holder system

5.1

System set-up

► When inserting the motor components into the sterilizer tray, please note that there is a greater need for space

due to the inclination of the motor components. ► When installing several holders, select the sterilizer tray in accordance with the holder requiring the most space

Manufacturer

(maximum height). ► Use only the supplied nut and bolt to install the holders. Other nuts and bolts may not be compatible with the

holders. Date of manufacture

Note If lost, these components can be reordered (replacement bolt set JG303R).

5.2 Manufacturer's batch name

Manufacturer order number

Non-sterile medical device

According to US federal law, this product may only be sold by a physician or by the order of a physician CE mark in accordance with Regulation (EU) 2017/745

Medical device

Note To ensure that the washing machine's spray jet reaches all sides of the components and the components can be easily taken from the holder, a sufficient distance between the individual components and between the components and the sterilization tray must be maintained. ► Use the Aesculap installation kit GB459R and, if using the nut SW7, also use a socket key JJ589R. ► Select the appropriate sterilizer tray, see System set-up. ► Install the holder system, see Fig. 3/4. Make sure the individual components are adequately spaced apart from

each other and from the sterilization tray. Installation in AESCULAP Aicon sterilization trays ► hen mounting holder systems in AESCULAP Aicon sterilization trays, tighten the nut-bolt connection to the block sufficiently tightly for a secure fit of the holder. The undulating bottom of the sterilization trays is deformed inwards towards the holder during this process. This is desired and non-critical and necessary for a secure fit of the holder. ► Make sure that the bolt head only projects slightly above the undulating tray bottom after installation.

6. 1.

About this document

Note General risks of surgical interventions are not described in these instructions for use.

1.1

Scope

These instructions for use apply to ECCOS holders for motor components marketed by Aesculap. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may emerge during the use of the product. Warnings are marked as follows:

Mounting the holder in the tray

CAUTION Risk of corrosion deposits on motors/handpieces! ► Only use tools made of stainless steel (such as the Aesculap installation kit GB459R and the socket key JJ589R) to install the holder systems.

Validated reprocessing procedure

► Observe the instructions for use for motor components for preparation. ► Observe the preparation cycle as follows:

1. Operative procedure 2. Disposal in the sterilizer tray with holders in the OR 3. Mechanical cleaning and disinfecting 4. Maintenance of the handpieces 5. Sterilization in the sterilizer tray with holders 6. Provision for operative procedure

6.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

WARNING Indicates a potential danger. If not prevented, minor or moderate injuries may result.

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.

CAUTION Indicates a potential damage to property. If not prevented, the product may be damaged.

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

2.

General information

2.1

Purpose

Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this.

Objective/Function The attachment systems are designed for repeated use with certain stable formed containers. They are used for holding items to be washed and/or sterilized for processing, sterilization, transport and storage in a sterile barrier system (e. g. sterilization containers, etc.).

2.2

Application environment

Use in RUMP area (Reprocessing Unit for Medical Products ) and in sterile area.

2.3

Indications/contraindications

The holding system does not have an individual medical indication/contraindication. Because the product is a system component of an Aesculap motor system, the medical indications/contraindications are specified in the descriptions of those devices.

3.

Safe handling

► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial

sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-

ufacturers liability: – Use the product only in accordance with these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Follow the instructions for use of the components to be processed. 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.

Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

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 processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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 processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".

6.3

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.

6.4

Preparation of motor components for mechanical preparation

► Remove all attached components, such as tools, tubes and adapters. ► Only use holders intended for the respective components. Observe the symbol marking on the holder (see instruc-

tions for use of the component to be processed). ► Mount all components on their respective holders, see Fig. 2.

For components that are exceedingly encrusted e.g. with coagulated proteins, the mechanical cleaning process may not always lead to acceptable results. ► For components that are highly contaminated, manual pre cleaning is required (see instructions for use of the components to be processed). Some holders are designed for internal rinsing. ► For holders which require internal rinsing, close the unused jet opening of the cleaning machines in order to achieve sufficient jetting pressure.

6.5

Inspection, maintenance and checks

► Carry out control, maintenance and checks in accordance with the instructions for use of the components. ► Set aside the product if it is damaged.

6.6

Packaging

► Pack screen baskets properly in accordance with sterilization process (e.g. in Aesculap Sterile Containers). ► Ensure that the packaging will prevent a recontamination of the product.

6.7

Steam sterilization

► Carry out sterilization in accordance with instructions for use of the components.

6.8

Storage

► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

7.

Accessories/Replacement Parts

Art. no.

Name

Intended use

GB459R

ECCOS Installation kit

Nut and bolt SW10

JJ589R

Socket key SW7 150 mm

Nut SW7

JG303R

Replacement bolt set

TA009721

Instructions for use ECCOS

8.

Technical Service

CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals granted. ► Do not modify the product. ► Contact our national B.Braun/Aesculap representative for service and repair. 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.

9.

Disposal

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packagings. Note The operator must process the product before disposalsee Validated reprocessing procedure. TA009721

2020-12

V6

Change No. AE0060512