Ackermann

Needleholder, 3 mm, cross serrated

Reusable Surgical Instruments

12 Pages

STENT PLACEMENT KITS en Reusable Surgical Instruments Important All products covered by these reprocessing instructions can be found in the appendix. Before using these products, please read the following information thoroughly! Warnings • Reusable instruments from Ackermann Instrumente GmbH are supplied non-sterile, which is indicated on the product label by the following symbol: Not for use in patients allergic to NI, CR, brass or aluminum. The products are contraindicated for all applications other than the intended use described. If there are any product-specific contraindications, these are listed in the instructions for use of the respective product. Limitations on Reprocessing The reusable surgical instruments are designed for repeated use. The service life of the instruments results from reprocessing and handling. Therefore, a limit for the number of reprocessing cycles cannot be specified. Before each use, theproduct must be checked for function and damage. Damaged products must be disposed of. Warning • • • • • These products must be cleaned and sterilised before first use in accordance with the instructions in this reprocessing manual. 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. 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 device specific efficacy and suitability of the actually performed cycle. Respective evaluation usually requires equipment qualification and device specific performance qualification / validation. In case of any serious incident that has occurred in relation to the respective device shall be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established. You can inform us using the form provided on our homepage. If product-specific instructions for use are enclosed with the products, these must also be followed. Intended Use Reusable surgical instruments manufactured by Ackermann Instrument GmbH are intended to perform general surgical procedures. It is the responsibility of the attending physician to determine the use of each product for a specific operation. The intended use of the respective product group can be found in the appendix. Contraindication(s) The instruments are contraindicated for use on the central circulatory system and central nervous system. If the instruments are used on patients infected with prion-based diseases (e.g. CJD) or HIV, the instrument must not be reused. Even after reprocessing and sterilization, the risk of crosscontamination cannot be eliminated and the instrument must be destroyed. Inspection before Use Warning Before operating the instruments, a visual inspection and a functional test must be carried out in accordance with section “Functional control and maintenance of the products in the reprocessing cycle according to DIN 96298-4”. Non-functional instruments must be discarded. Reprocessing Instructions Preparation before Use Warning Ackermann reusable products are supplied nonsterile and must be cleaned and sterilized before first use and before each subsequent use. The packaging cannot withstand the high temperatures of autoclaving and should be disposed of before sterilization. Rinse Cleaning Warning Thermal disinfection Improper cleaning, rinsing, and drying can result in potentially hazardous residues or inadequate sterilization. Drying Always ensure that the products are used and reprocessed by qualified personnel with appropriate experience in hospital hygiene and sterilization techniques. To ensure safe and effective reprocessing of the products, the following instructions have been validated by the manufacturer for effectiveness and compatibility with the instruments. It is the responsibility of the end user to ensure that cleaning and sterilization is indeed performed with appropriate equipment, materials and personnel to achieve the desired result. Any deviation from these instructions should be evaluated for effectiveness and possible adverse consequences. Warning All reusable Ackermann products must be subjected to reprocessing as described in the following sections before being used for the first time. Follow the instructions and warnings of the manufacturers of the decontamination, disinfection and cleaning agents to be used. Cold DI water times and wipe off excess oil with a lint-free cloth. Exposure time 60 secs. / 1 min. Visual and Fuctional Inspection Neutralizing agent acidic (e.g. Neodisher® Z) Concentration 0.10% Rinsing temperature Cold DI water Visual Inspection Exposure time 120 secs. / 2 mins. Disinfection temperature 90 °C (A0 3000) Visual inspection for cleanliness • The instruments should be free of macroscopic contaminants. Exposure time 300 secs. / 5 mins. Drying 60 mins. / 1 hour Pre-Cleaning Instruments, or fully disassembled instruments if applicable, must be brushed under cold water until all visible contamination is removed. If the instrument has a flushing port, the lumen of the shaft must be flushed for at least 10 seconds through the flushing port with a water jet gun (static pressure greater than 4 bar) after manual brushing. The instruments are then treated in a 0.5% alkaline enzymatic (e.g. Neodisher® Mediclean forte) ultrasonic bath for 10 minutes. Finally, rinse again for 30 seconds with a water jet gun. Automated Cleaning 1 The automated cleaning was validated with Neodisher® Mediclean forte (alkaline-enzymatic: pH-value 10,4 – 10,8) for cleaning and Neodisher® Z (acidic: pH-value 3,0 – 2,6) for neutralization. Steam Sterilization 2 Procedure Triple fractionated pre-vacuum Temperature min. 132°C Duration min. 3 mins. Drying time min. 20 mins. The instructions provided above have been validated as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process. 1 Warning Rinsing temperature Step Parameter Pre-rinse Rinsing temperature Cold tap water Exposure time 180 secs. / 3 mins. Cleaning temperature 55°C Exposure time 600 secs. / 10 mins. Detergent Alkalineenzymatic (e.g. Neodisher® Mediclean forte) Cleaning Concentration 2 0.50% Products marked as nonfunctional must be discarded. The following tests and maintenance must be performed by qualified personnel. Visual control for missing parts • All parts such as screws, pins, springs, valves, hooks, etc. must be present. If this is not the case, the whereabouts of the missing parts must be clarified. Visual control for breakage • If parts (such as tips, teeth, springs, working ends, TC inserts) are missing due to material breakage, the whereabouts of the missing parts must be clarified. Check for deformation • Instruments with deformed working ends, cutting edges, tips, etc. need to be sorted out. Visual inspection for corrosion • Instruments with visible corrosion in the form of pitting, fretting, stress or crevice corrosion must be sorted out. Visual inspection for discoloration • Instruments with a discoloration must be sorted out. Validated with washer-disinfector Miele PG 8535 Validated with steam autoclave Lautenschläger ZentraCert Visual inspection for cracks • Instruments with a crack must be sorted out. Function Control and Maintenance of the Products in the Reprocessing Cycle acc. to DIN 96298-4 Visual inspection of coatings • Coatings must be free of imperfections and notches. If damage to a coating is detected, this instrument must be sorted out. Warning If the product is damaged or suspected of being damaged, do not attempt to repair the product yourself. Do not reuse damaged instruments. Warning If a product-specific inspection or maintenance is required, the relevant information can be found in the instruction of use for the respective product. Maintenance Maintenance is always performed prior to functional testing. Oils can be applied by squeeze, spray, or pipe. Oil the joints and sliding surfaces in a directed way, then move the joint and sliding surfaces several Visual inspection of markings • The marking must be legible. If the instrument is marked with a machine-readable marking, this must be readable with an appropriate scanner. If the marking is no longer legible, the instrument must be sorted out. Fuctional Check Function check for clamps • The clamps must have a uniform, backlashfree movement. • The lock must hold securely in any position. • The working ends must be congruent with each other. • The teeth, if any, must mesh without hooking. Function check for scissors • When closing the scissors, there must be minimal and continuous friction between the scissor blades, but no noticeable snagging. A cutting test can be carried out to eliminate any doubts. Function check for needleholders • The needleholder must have a smooth, backlash-free movement. • The catch must hold securely in any position. • The working ends must be congruent. • The working ends must close completely; if a gap is detected, the tooth profile must be checked for wear and replaced if necessary. Function check for tweezers • The teeth must engage without hooking. This is checked by pressing the tweezer legs together. The tips of the forceps (grasping surfaces) must be congruent with each other and must not slide sideways from each other when the forceps legs are pressed together. Function check for retractors • The retractor must hold securely in any position during opening. This is checked by opening and simultaneously applying pressure to the arms. Valves must be easy to insert and still fit securely. Functional check for chisels and osteotomes with handles made of plastics or aluminum • The components of the instrument must be firmly connected to each other without wobbling. The working ends must be checked for the presence of nicks. Impact caps with severe deformation or splintering must be discarded. Function check for bone splitters and roungeurs • The rongeurs with spring must open independently. The cutting edges should not have any major nicks, otherwise the function according to the intended purpose is no longer guaranteed. Rongeurs with severely damaged cutting edges must be discarded. Labeling and Storage Labeling Warning Please pay attention to the symbols on the product label and in this instruction for use. Care must be taken to ensure that the instruments are fully traceable at all times. Storage Conditions Storage conditions can be found on the product label. IFU_00156_Reusable_Surgical_Instruments_INT_08/24 0483
File Type: PDF
File Size: 473 KB
File Name: Ackermann - IFU_00156 - Reusable Surgical Instruments - 2024-08.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions

Preview

Page 1

Previous PageNext Page