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The Retention Plate and the Suture Needles are disposable. Reuse may cause the needle to fatigue and break, which could cause patient injury. Reprocessing may lead to changes in material characteristics such as corrosion and dulled edges, which may impact the strength of the device and compromise performance.

Reprocessing of single-use devices can also cause cross-contamination leading to patient infection. These risks may potentially affect patient safety. Reuse may cause the Retention Plate to fatigue and break, which could cause patient injury. Reprocessing of single use devices can also cause crosscontamination leading to patient infection.

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Inspect the disposable needle and Retention Plate for damage to the products or hatasos eco slim sterile barriers. Do not use if product is damaged or sterile barrier is compromised. Inspect the Suture Passer prior to use to ensure proper mechanical function.

To load the Retention Plate, follow the directions printed on the Loading Tool card packaged with the Retention Plate. Remove thin white insert from loader housing Figure 1, Step 1.

Figure 1. With the Suture Passer jaw closed, insert jaws into opening of the loading tool Figure 1, Step 2. While maintaining the Loading Tool in a flat position do not angle or rotateslide the Loading Tool forward until it stops Figure 1, Step 3.

Slide the Loading Tool off the instrument and discard. Visually inspect the top jaw of the flexible Suture Passer to ensure that the retention plate was fully assembled. Plate tabs should be in pocket of top jaw.

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To load the Suture Needle into the Suture Passer, insert the sharp end of the needle into the rear of the instrument near handle with the flag up. Engage the needle by aligning the notch in the needle to the nub on the Suture Passer. Load the suture.

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With hatasos eco slim jaw closed, wet the distal end with sterile water, and actuate the needle deployment lever ONCE to confirm that the needle deploys and retracts. Remove the suture from device.

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Open the jaw of the Suture Passer by pressing the Jaw Release button and load the suture into the tip of the device Figure 2. Suture should be loaded with the short tail down Figure 2. Ensure that the suture is pulled completely to the proximal end of the slot at the tip of the device.

Though not required, suture management may be improved if one of the tails is 1 to 2 cm long. Figure 2. With suture loaded, the jaw of the Flexible Suture Passer closed, and needle retracted, not visiblepass the Suture Passer through the cannula into the surgical site under direct visualization.

Apply slight tension to ensure that the suture does not become hatasos eco slim on itself or in the Suture Passer as it is passed through the cannula. When ready to pass the suture, open the jaw and position the jaws of the Suture Passer at the desired suture location. Close the jaw with a secure but gentle grasp.

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Applying too much force when hatasos eco slim tissue will impede passage of the needle and suture. NOTE: If more space is required to open the jaw, pull the cannula proximally once the device is inside the surgical space. To deploy the needle, pull the needle Deployment Lever. If significant force is required to pass the needle, loosen the grip on the tissue and try again. After passing the suture, release the needle Deployment Lever allowing the needle to fully retract.

Open the Jaw and remove the Suture Passer from the cannula. To release suture from the Retention Plate, pull the suture perpendicular to the longitudinal shaft of the device out the side opening of the Top Jaw. Immediately remove and discard the disposable Suture Needle and Retention Plate after completion of the surgery. Grasp the Plate with a Needle Driver and remove from the instrument.

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. This normally requires validation and routine monitoring of the process. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences. Preparation Clean instruments as soon as possible after use. If cleaning must be delayed, wet the instruments in a compatible liquid solution to prevent drying and encrustation of surgical soil.

Avoid prolonged exposure to saline to minimize the chance of corrosion. Remove excessive soil with a disposable wipe. Prior hatasos eco slim sterilization, instruments should be cleaned by either automated or manual means described below. Pre-Cleaning Manual 1. Flush internal areas with a warm detergent solution. Pay close attention to lumens, cannulations, holes, threads, crevices, seams, and any hard to reach areas. While flushing, actuate any moveable mechanisms, hinged joints, box locks, or spring-loaded featuresto free trapped blood and debris.

If the components of the instrument can be retracted, retract or open the part while flushing the area. For instruments with flexible shafts, flex the instrument while flushing. For instruments with lumens, brush the internal surfaces of the lumen. Ultrasonically clean the instrument for 10 minutes in neutral ph detergent, prepared in accordance with the manufacturer s instructions. Rinse the instrument thoroughly with warm water. Load instruments into washer disinfector so that hinges are hatasos eco slim and cannulations and holes can drain.

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Place heavier instruments on the bottom of containers. Do not place heavy instruments on top of delicate instruments. For instruments with concave surfaces, such as curettes, place instrument with the concave surface facing downward to facilitate draining.

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Automated Cleaning Parameters 1. Effective automated cleaning can be achieved using the following parameters: two cold water pre-washes minimum hold of two minutes each ; a hot water enzyme wash minimum hold of 4 minutes ; followed by a hot water ph neutral detergent wash minimum hold 3 minutes at 60 C ; a hot water rinse minimum time 20 seconds ; a thermal rinse minimum hold of 1 minute at After automated cleaning, proceed to inspection, instructions below.

Prepare an enzymatic cleaning solution in accordance to the manufacturer s instructions. Soak soiled instruments hatasos eco slim a minimum of ten 10 minutes. Do not exceed hatasos eco slim C. When cleaning, fully immerse the instrument in the cleaning solution to avoid aerosol generation. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hard to reach areas, textured surfaces, or crevices.

When cleaning Instruments with cannulations or lumens e. Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic cleaning solution to flush hard to reach internal areas.

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When cleaning articulating instruments, those with moveable partsbrush with a soft non-metallic bristle brush to remove all traces of blood and debris. Pay close attention to threads, crevices, seams, and any hatasos eco slim to reach areas. Hatasos eco slim any moveable mechanisms, such as hinged joints, box locks, or spring-loaded features, to free trapped blood and debris. If the components of the instrument can be retracted, retract or open the part while cleaning the area.

For instruments with flexible shafts, flex the instrument obiettivo globale bruciare i grassi the cleaning solution.

Rinsing 7. Rinse the instrument thoroughly with filtered water at C, agitate for a minimum of 1 one minute; repeat rinse at least two additional times. When rinsing, pay particular attention to flushing cannulations, lumens, or holes with warm tap water. Also pay particular attention to internal areas and moveable parts.

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Actuate moveable parts while rinsing. If the components of the instrument can be retracted, retract or open the hatasos eco slim while rinsing the area. For instruments with flexible shafts, flex the instrument under the rinse solution. Drying 9. Dry the instrument immediately after final rinse. Use filtered compressed air to dry internal areas. After drying, proceed to Inspection instructions. Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tubes and holes, moveable hatasos eco slim.

If bubbling is observed, blood is present.

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Rinse instruments thoroughly after using hydrogen peroxide solution. If soil is still present, clean the instrument again. Make sure that: Cutting hatasos eco slim are free of nicks and have a continuous edge, Jaws and teeth are aligned properly, Moveable parts have smooth movement without excessive play, Locking mechanisms fasten securely and close easily, Long, thin instruments are free of bending and distortion. If a specific location is not identified for an instrument, it may be placed in the general purpose area pin-mat ensuring that the sterilant has adequate access to all surfaces including difficult to reach areas, lumens, etc.

Use a validated, properly maintained and calibrated steam sterilizer. Disclaimer of Warranty and Limitation of Remedy This warranty is restricted to repair or replacement by DePuy Mitek, at its option, of the product found to be defective during the warranty period. Damage inflicted to the product by the user may void the warranty. This includes, but is not limited to, any attempted repairs by unauthorized service providers, using a sterilization method not approved by DePuy Mitek, and using the product in a way that is not intended.

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All warranties apply to non voglio perdere peso solo grasso original buyer and are not transferable. In no event shall DePuy Mitek be liable for any anticipated profits, consequential damage, or loss of time incurred by the buyer with the purchase or use of any product. La placa de retención y las agujas de sutura son desechables. La reutilización de la aguja podría causar su deterioro y rotura, lo que a su vez podría causar lesiones al paciente.

El reprocesamiento puede provocar cambios en las características de los materiales, por ejemplo corrosión o filos romos, que podrían influir en la resistencia del dispositivo y afectar a su funcionamiento. El reprocesamiento de los dispositivos de un solo uso también puede provocar contaminación cruzada, con la consiguiente infección del paciente.

Estos riesgos pueden afectar potencialmente la seguridad del paciente.

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La reutilización de la placa de retención podría causar su deterioro y rotura, lo que a su vez podría causar lesiones al paciente. Para cargar la placa de retención, siga las instrucciones impresas en la tarjeta de la herramienta de carga que se encuentra dentro del envase de la placa de retención. Retire el inserto delgado blanco de la carcasa del cargador figura 1, paso 1. Con la mordaza del pasador de suturas cerrada, introduzca las mordazas en la abertura de la herramienta de carga figura 1, paso 2.

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Deslice la herramienta de carga hasta sacarla del instrumento y deséchela. Inspeccione visualmente la mordaza superior del pasador de sutura flexible para garantizar que la placa de retención ha quedado totalmente montada. Las lengüetas de la placa deben estar en la bolsa de la mordaza superior. Para cargar la aguja de sutura en el pasador de sutura, inserte el extremo punzante de la aguja en la parte posterior del instrumento cerca del mango con el indicador hacia arriba. Enganche la aguja alineando la muesca que hay en la misma con el nudo en el pasador de sutura.