Cogentix Medical Control Flow Administration Device Instructions for Use Rev G

Prescription use only Product reference number

SN

Serial number Consult instructions for use 30ºC

Store at room temperature

15ºC

Manufacturer Authorized representative in a European Community Not made with natural rubber latex

INDICATION The Control Flow Administration Device (Administration Device) is indicated for the delivery of injectable materials contained in standard 3 cc syringes.

DESCRIPTION The Administration Device is a chrome-plated die cast zinc instrument with a chrome-plated brass adapter, and a stainless steel lever, syringe dosage rod, and pivot point with pin. This device will hold and deliver the contents of Cogentix Medical 3 cc syringes.

WARNINGS/PRECAUTIONS »» The adapter is the only removable component. To remove the adapter from the Administration Device, Rotating Collar

hold the rotating collar while turning the adapter a quarter turn, then pull it off from the main body of the device. Do not use tools to remove the adapter or any other parts. Damage will occur if the adapter is removed improperly. Return damaged or faulty units to your distributor. »» Do not soak the Administration Device with other soiled/contaminated devices. Contamination from other devices may accumulate in the Administration Device crevices/moving parts making it more difficult to thoroughly clean. Inadequate cleaning may result in malfunction of the Administration Device release mechanism or restricted movement of the syringe dosage rod. »» To avoid pitting or corrosion of the metal surfaces, avoid contact with chloride or oxidizing solutions (i.e., saline, bleach, hydrogen peroxide, peracetic acid, etc.). »» Avoid cold soaks or prolonged exposures in highlevel disinfectants beyond the time or concentration specified by the manufacturer. These materials may damage the instrument finish and affect the functioning of the device. »» Detergent residue may result in staining and may interfere with sterilization if not thoroughly rinsed after cleaning.

INSTRUCTIONS Please read and understand all instructions prior to reprocessing the Administration Device. Select the preferred cleaning method, followed by disinfection or sterilization. Point of Use

The device is supplied non-sterile with one adapter.

Containment and Transportation

Transport the soiled device in a closed container/wrapping to a designated cleaning area. Remove/rinse visible debris from the device before it dries. Do not soak the device in a disinfectant prior to cleaning. Do not soak the device with other soiled devices as this may increase the amount of soil or contaminants in the crevices prior to reprocessing.

Preparation for Cleaning

Remove the adapter by holding the rotating collar while turning the adapter a quarter turn, then pull it off from the main part of the device. Extend the dosage rod fully to the back position by pressing the release mechanism and pulling the rod handle. During cleaning move the dosage rod to the front position by pressing the release mechanism and pushing the rod handle forward.

Cleaning: Manual

»» Rinse each component for at least 2 minutes under warm water to remove all visible debris. Manipulate the dosage rod, alternating between the front and back positions during rinsing. Use an irrigation syringe to flush all crevices. »» Soak each component for at least 5 minutes in a lukewarm water bath containing an enzymatic detergent per the manufacturer’s instructions. »» Brush each component for at least 2 minutes under the surface of the enzymatic detergent bath using a soft-bristle brush to remove any visible soil. Manipulate the dosage rod, alternating between the front and back positions, to access all crevices with the brush. »» Rinse all parts of the device for at least 2 minutes under warm running water to remove all detergent residues. Use an irrigation syringe to flush all device crevices. NOTE: Detergent residue may result in staining and may interfere with sterilization if not rinsed completely. »» Visually inspect each component under normal lighting conditions to verify all debris is removed. »» Repeat cleaning steps if debris is still visible on the device. »» Dry each component with a lint-free cloth or filtered compressed air.

Cleaning: Automated

»» Rinse and brush each component for at least 2 minutes with a soft-bristle brush under warm water to remove all visible debris. Manipulate the dosage rod, alternating between the front and back positions during rinsing. Use a syringe to flush all crevices. »» Place each component in an automated washer with the dosage rod on the Administration Device in the back position at an angle to allow draining. »» Run the automated wash cycle with the following MINIMUM parameters: -- 1 minute cold water prewash -- 1 minute hot water enzymatic wash -- 2 minute detergent wash at 66°C (150°F) -- 1 minute hot water rinse -- 7 minute drying at 115°C (239°F) »» Visually inspect each component under normal lighting conditions to verify all debris is removed. »» Repeat cleaning steps if debris is still visible on the device. Dry each component with a lintfree cloth or filtered compressed air.

High Level Disinfection: Manual

»» After cleaning, immerse the adapter and the Administration Device, with the dosage rod in the back position, in a 2% high-level disinfectant solution (e.g., alkaline glutaraldehyde) per the manufacturer’s instructions. »» Rinse each component for at least 1 minute by immersing in purified water with agitation. Repeat rinse step 3 times. »» Dry each component with a lint-free cloth or filtered compressed air.

LIMITATIONS After cleaning and disinfection or sterilization, verify functionality prior to re-use. End of life is normally determined by wear and damage due to use.

Release Mechanism

Syringe Dosage Rod

Rod Handle

Adapter Lever 2

3

English

DESCRIPTION OF SYMBOLS