LAPAROSCOPIC INSTRUMENTS Instructions for Use

Ackermann

LAPAROSCOPIC INSTRUMENTS INSTRUCTIONS FOR USE IMPORTANT Before using these products, please read the following information thoroughly!

WARNING Reusable Ackermann products are delivered unsterile, indicated on the device label by the following symbol:

Prior to their first use, the devices need to be cleaned and sterilized as described in the reprocessing section of this document.

WARNING

LIMITATIONS ON REPROCESSING With proper cleaning, sterilization, and handling, the reusable Ackermann products can be used a maximum of 50 times. Careful handling and strict adherence to these instructions is essential to ensure safe usage up to 50 times. This, however, does not automatically determine end of life. The product may well be used beyond that threshold if maintained and treated well. Repeated reprocessing has minimal effect on these devices. End of life is normally determined by wear and damage due to use. In accordance with this IFU each instrument needs to be examined prior to every use.

REPROCESSING INSTRUCTIONS

The Ackermann Laparoscopic Instruments are intended to be used for Laparoscopic surgeries. The use of the respective product for a specific operation is the responsibility of the treating physician.

Always ensure that the devices are handled and processed by qualified personnel who are specially trained and adequately experienced in regard of hospital hygiene and sterilization technology. In order to ensure safe and effective reprocessing of the devices, the following instructions have been validated for efficacy and compatibility with the devices by the manufacturer. It is the responsibility of the end user to ensure that the cleaning and sterilization is actually performed using appropriate equipment, materials, and personnel to achieve the desired result. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences.

CONTRAINDICATIONS

WARNING

Not intended for use with patients that have allergic reactions to NI- ; CR- steels or to brass or aluminium.

Before initial use and any subsequent use, all reusable Ackermann products have to be subject to reprocessing as described in the following sections. Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used.

The instruments may only be used by trained and, if applicable, instructed physicians. Disinfection, cleaning and sterilization may only be performed by specially trained medical personal.

INTENDED USE

GUIDELINES FOR CARE, MAINTENANCE & CLEANING REPROCESSING

PREPARATION PRIOR TO FIRST USE

WARNING The following instructions only apply to reusable Ackermann products. Please note that any deviation from these instructions, including the use of cleaners / detergents not specifically indicated in these instructions will require an evaluation of devicespecific efficacy and suitability of the actually performed cycle. Respective evaluation usually requires equipment qualification and device specific performance qualification / validation.

The reusable Ackermann products are delivered non-sterile and must be cleaned and sterilized before initial use and before each subsequent use. The packaging cannot withstand the high temperatures of autoclaving and should be discarded before sterilization.

PREPARATIONS AT THE POINT OF USE PRIOR TO REPROCESSING Remove all traces of contamination and if applicable disassemble the instrument

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immediately after use to avoid incrustation. Do not use fixative agents or hot water (>40°C). Avoid using a metal brush, steel wool or other cleaning devices containing metal in order to avoid risk of insulation damage or corrosion. Storage and transport of the instruments to the reprocessing location must be ensured in a sealed container.

CLEANING WARNING Failure to properly clean, rinse and dry a device may result in retention of potentially hazardous residues or in inadequate sterilization.

Manual Pre-Cleaning The instruments or if applicable the disassembled instruments must be brushed under cold water until all visible contamination is removed. If the instrument has a flushing port, the lumen of the sheath must be rinsed for at least 10 seconds via its flushing port with a water jet pistol (static pressure above 4 bar) after manual brushing.

Automated Cleaning Associated parts are to be stored together in order to facilitate a subsequent identification. Make sure that instruments do not contact each other. Devices from different materials such as titanium, brass, aluminium, stainless steel, etc. need to be cleaned separately in order to avoid formation of a rust film. Composite instruments particularly stainless steel combined with ceramics) need to be placed with sufficient distance to other products so they do not break due to the pressure of different thermal expansions.

RECOMMENDED PROCESS-EQUIPMENT • Washer: Miele Type G7836 CD • Cleaners: TWIN PH10 and TWINZYME (Borer Switzerland)

AUTOMATED CLEANING CYCLE Two-component alkaline-enzymatic cleaning program: • 3 min pre washing with cold tap water • Drain • 10 Min washing at 45°C w tap water and • 0,3% dosing TWIN PH10 at 35°C • 0,2% dosing TWIN ZYME at 40°C • Drain • 2 min intermediate rinsing with warm deionised water (>30°C)

• Drain • 1 min intermediate rinsing with cold deionised water • Drain • 5 min thermal disinfection at >90°C • 30 min drying

visually check for damage and wear. Blades should be even and without notches. Long and narrow instruments (especially jointed instruments) should be particularly checked for damages. If instruments are part of a larger set they are to be checked together with all associated components.

STERILIZATION

WARNING

WARNING Autoclaves vary in design and performance characteristics. Cycle parameters should always be verified against the autoclave manufacturer’s written instructions for the specific autoclave and load configuration being used. Sterilization is preferably performed by steam sterilization. The following cycles have been validated in accordance to ISO 17665. 132°C, 4 mins (wrapped), minimum 20 mins drying or 134°C, 4 mins (wrapped), minimum 20 mins drying

PACKAGING Packaging suitable for steam sterilization must comply with the requirements according to DIN EN ISO 11607 / ANSI/ AAMI ST79 / AAMI TIR12:2010, for example, disposable sterilization packs (single or double packs) temperature resistant up to at least 137°C (279°F) and sufficient steam permeability, which provide sufficient protection against mechanical damage, or sterilization containers which need to be maintained according to the manufacturer‘s instructions.

MAINTENANCE Apply a small amount of high-grade surgical lubricant on all joints or other moveable parts which are supposed to move smoothly. Sort out all blunt or damaged instruments. Clearly damaged instruments (cracks on the insulation, breakage, strongly bleached polymer handles or coatings) are NOT to be reused but repaired or disposed of.

SYMBOLS USED ON LABELLING (ACC. DIN EN ISO 15223-1) Legal manufacturer Manufacturing date Consult instructions for use Batch code

In case of present or suspected damage to the devices, do not try to repair the instrument. Avoid any further use of damaged instruments!

Product number Caution, consult accompanying documents

STORAGE

Do not use if package is opened or damaged

Store instruments secured against mechanical damage. Use additional wrapping to protect against dust. Do not stack instruments which are packed sterile; especially do not place heavy items on top in order to avoid damage to the sterile packaging of other instruments.

Non-sterile Keep out of direct sunlight Protect against moisture

ADDITIONAL INFORMATION

ONLY

Do not exceed maximum loading capacity of the sterilizer when processing multiple instruments in one sterilization cycle.

APPENDIX

Prescription use only CE-Marking

CONTACT DETAILS

All products covered by these instructions are listed below: • Laparoscopic instruments with flushing port, Class I

Ackermann Instrumente GmbH Eisenbahnstrasse 65-67 78604 Rietheim-Weilheim Germany Phone: Fax: E-Mail: Web:

+49 (0)7461 966 17 - 0 +49 (0)7461 966 17 - 70 [email protected] www.ackermannsurgical.com

End of document

TESTING AND INSPECTION Jointed instruments are to be tested for ease of movement (avoid too much backlash). The functionality of ratchet mechanisms needs to be checked. All instruments: IFU_00151_Laparoscopic_Instruments-Revision _05/21

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