X-ray templates

en ®

AESCULAP X-ray templates 1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for x-ray templates that are cleaned by wipe disinfection. ► 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: WARNING Indicates a possible threat of danger. If not avoided, minor or slight injuries or damage to the product may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

Note The short summary of safety and clinical performance of the product is available in the European Database for Medical Products (EUDAMED).

2.1

Areas of use and limitations of use

2.1.1

Intended use

3.

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 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. The recommended chemical was used for validation. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com

3.2 Limitations on reuse ■ There is no set maximum number of uses and reprocessing cycles for the product. ■ The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling, storage and transport of the product.

■ A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

3.3

Cleaning/Disinfection

3.3.1

Product-specific safety information on the reprocessing method

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. Risk of damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

3.4

Wipe disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

RT

1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

II

Wipe disinfection

RT

≥1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

X-ray templates serve for preoperative planning on the basis of x-ray images.

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. ► 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 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. ► Always adhere to applicable standards.

RT: *

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.

4.

Notes on surgical procedures The medical professional will make decisions on concrete applicability based on the warranted properties and technical data. ■ It is the user's responsibility to ensure that the surgical procedure is performed correctly. ■ Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. ■ The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

Room temperature Validation was performed with Meliseptol® wipes sensitive (B. Braun)

Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the application time ( 1 min minimum).

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

The product is supplied non-sterile and must be used under non-sterile conditions. ► Inspect the new product after removing its transport packaging and prior to first use to ensure it is in good working order.

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.

2.3

5.

2.2.2

Sterility

Application

WARNING Danger to the patient! The scale of the x-ray image may differ from the scale of the template. X-ray image projection can deviate from the depiction of the implant components on the x-ray template. ► Verify planning intraoperatively.

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. TA019000

2021-03

Change No. 63662