EXPLORENT Holding Instruments Instructions for Use

Instruction for use

Important note Carefully read this instruction before using the described medical products. Keep them in a safe place for future reference and make them easily available. Carefully read these warnings. Improper use of the instrument may cause a serious injury. Caution: According to US legislation, this product may be used only by a physician or under his direct instructions.

Scope Suitably trained and qualified personnel may use the instruments according to the described intended use. It is imperative that the surgeon become familiar with the instruments in prior to surgical application. These instructions should be kept in a conspicuous place close to the instruments.

Intended User The instruments may be used only as intended, in specialized medical fields, and by appropriately trained and qualified staff. The treating physician or the user is responsible for selecting the instruments for specific applications or a surgical procedure, and for appropriate training, information, and adequate experience for handling the instruments.

Product groups for which this user manual is valid Forceps, Appliers, Adapter, Inserter

Product description and Intended use An instrument, typically used in surgery to hold different kind of materials. Holding instruments are used to hold or clamp different materials in different applications by hand.

Indications Holding instruments are used to hold or clamp different materials in different applications by hand.

Contraindications The products are contraindicated for any indication other than the mentioned.

Inclusions/Exclusions of patient groups There are no special features to consider in adults or children.

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Device Combination The devices are intended to be used in standard surgical practices. The device does not contain specific interfaces to combination devices that would require specific attention.

Life-span The Life-span of this product is highly dependent on the frequency and the care during the application. Based on the device design and its indications, a lifespan of 50 cycles can be guaranteed.

Caution This instrument was designed only for surgical use and may not be used for any other purpose. Improper handling and care, as well as misuse of the instrument may result in premature wear. Use only with moderate force.

Caution The instrument is NOT STERILE.

Caution Before using the instrument for the first time, and before every subsequent use thereafter, it must be reprocessed according to the instructions for use.

Handling During transport, cleaning, maintenance, and storage, the instruments must be handled with great care and kept in suitable containers. Instruments must be cleaned thoroughly immediately after every use, and special attention must be given to slits, locks, closures, and other areas that are difficult to reach. Heavy soiling is to be removed immediately after use by immersion and rinsing in cold water (<40°C). Do not use any solvents or hot water (>40°C), since this can result in encrustations and thus hinder the conditioning process. Remove corrosive residues such as caustics or pharmaceutical products (e.g. iodine), because otherwise there will be a risk of corrosion. Do not place instruments on top of each other during use or cleaning. To prevent damage, the mechanical sensitivity of the instruments should be taken into account when they are being set down or placed in storage. Never place instruments in physiological saline, since prolonged contact will result in pitting and rust.

Product group: Holding Instruments

Caution Only use cleaning agents and disinfectants whose effectiveness and material compatibility with surgical instruments have been checked and approved by the manufacturer of the chemicals. Examples of suitable active ingredients: 1. Ortho-Phtalaldehyde 2. Ethandial, Didecyldimethylammoniumchloride 3. Fermacidal, Glutaraldehyde 4. Glucoprotamine 5. Sodium carbonate peroxyhydrate Disinfectants that meet the test criteria of the VAH (Association for Applied Hygiene E.V.), FDA or other national certification bodies can also be used. Disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components should not be used to reprocess evonos products.

Pre-cleaning Clean instrument surfaces and cavities with soft brushes only (do not use metal brushes, abrasive sponges or abrasives). Clean the product in the solution until no residues are visible on the surface. Then clean with cold water and a water jet cleaning gun for about 10 seconds and a pressure of 2.5 - 4 bar. Make sure all areas are flushed. Check all moving parts for cleanliness to ensure proper operation. Instruments with joints should be opened and, if possible, cleaned in disassembled condition. If applicable, brush through non-visible surfaces at least 5 times with a suitable cleaning brush. Rinse the product completely (all accessible surfaces) under running water. Move moving components such as set screws and joints during flushing. Drain the remaining water sufficiently. Afterwards dry instruments. Use soft, lint-free cloths or compressed air if necessary. Use cleaning agents according to the manufacturer's instructions.

Ultrasonic cleaning (optional)

Each time the instruments are used, they must first be inspected for breaks, cracks, deformations, damage, and functional capability. Areas such as blades, points, closures, locks, snaps, and all moving parts must be inspected with special care. Worn, corroded, deformed, porous, or otherwise damaged instruments must be separated from the others.

Clean instruments in the ultrasonic cleaning bath (frequency 35 kHz) for at least 3-5 minutes. Make sure that all accessible surfaces are moistened and acoustic shadows are avoided. Sounding time: 3 - 5 min Frequency: 35 - 40 kHz Temperature: max. 40°C/104°F Temperatures above 50°C /122°F can lead to blood incrustation. For persistent residues, e.g. on joint parts: Hold instrument tip in ultrasonic bath and move. Insert articulated instruments into the ultrasonic bath when open. After ultrasonic cleaning: 1. Thoroughly flush instruments with a cleaning gun with deionized water for at least 15 seconds. 2. Dry the instruments manually on the outside using a sterile, lint-free disposable cloth or swab, cavities with filtered compressed air.

Date: 30.04.2020

93-900007_Holding_Instruments_Rev.01

Inspection prior to reuse

Machine washing (automatic) Follow the operating and loading instructions of the manufacturer of the washer. If possible, instruments should be disassembled for cleaning. Instruments with joints should be opened for cleaning. Place the instruments on a suitable instrument tray and load the washer-disinfector. Machine - PH-Alkaline, > pH10 - 3 minutes pre-wash with cold water (<25°C /77°F) - Drain - Wash for 10 minutes at 55°C/131°F with demineralised water (deionised water) - Drain - 2 minute intermediate rinse with demineralized water (deionised water), > 10°C/55°F - Drain - Perform mechanical thermal disinfection taking into account the national requirements regarding the A0 value (see DIN EN ISO 15883), with demineralised water (deionised water) - Drying according to program for washer-disinfector

Machine drying Drying of the instrument surfaces during the drying cycle (washer-disinfector). If necessary, a lint-free cloth can be used for manual drying after the automatic cycle. Sterile compressed air can be used to dry the inner lumens.

Inspection, function test, and care After washing and disinfection, perform a visual inspection for cleanliness, put the instruments back together, if necessary, and perform a function test. The instrument must be free of visible soiling. Otherwise the instrument must undergo a cleaning process again. Instruments with spots must be separated from the others. Before each use, the instrument must be checked to make sure that it is intact (check for breaks, cracks, indentation, deformation, or malfunction). Particular attention is to be given to special areas like working ends (cutting edges), joints and closures, pins and bolted connections, snaps and locks, and all moving parts. Wear parts (e.g. silicone tubes, scalpel blades) are to be removed very carefully. After putting disassembled instruments back together, check them to make sure that they function properly. We recommend an autoclavable instrument oil (e.g. DAB 8 paraffin oil) to care for the instrument, especially the moving parts (e.g. joints). Remove excess oil.

Packaging Sterilize the instruments in suitable packaging according to ISO 11607 and AAMI.

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