APEX Knee and OMNIHip System Instrumentation Instructions for Use

IFU-011 rev I MAY2019 OMNIlife science, Inc. 480 Paramount Dr. Raynham, MA 02767 USA www.omnils.com (508)824-2444 Rx: Federal law (USA) restricts this device to sale or use by or on the order of a physician. APEX Knee™ System devices conform to

exposure time. Other sterilization methods are possible but must be maintained by the user. The following Cleaning and Sterilization parameters have been validated and are recommended: Point-ofUse

Pre-Clean

for class I devices or

2797 for class IIa devices MDSS GmbH Schiffgraben 41 30175 Hannover Germany OMNIHip™ System devices do NOT have CE approval APEX Knee™ System and OMNIHip™ System Instrumentation DESCRIPTION OMNI surgical instruments are supplied by OMNIlife science specifically to prepare the affected joint for the Apex Knee™ or OMNI Hip™ System implants.

Cleaning (manual)

MATERIAL OMNI surgical instruments are manufactured from medical grade stainless steels and plastics. All instruments are user sterilized and are re-usable unless specified otherwise. INTENDED USE The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee™ or OMNI Hip™ Systems. A Surgical Technique can be obtained from OMNIlife Science or its representatives. CLEANING AND STERILIZATION Surgical instruments are supplied non-sterile. Remove instruments from all individual sales packaging, clean and place in the appropriate location in the instrument pan provided by OMNI prior to sterilization. Autoclave sterilization is recommended. The autoclave must be properly maintained by the hospital and regularly checked to assure the recommended sterilization temperatures are reached for the entire

Cleaning (automated)

Prompt, initial treatment to remove and/or prevent drying of soil and contaminants is recommended to facilitate subsequent cleaning steps after each use. - Disassemble any instrumentation that requires disassembly per manufacturer’s instructions provided before cleaning. -Thoroughly Clean all instruments before sterilization, including the instrument tray. -Submerge instruments in enzymatic detergent & soak for 10 minutes per manufacturer’s instructions. - Scrub submerged articles with a soft sponge & agitate. -Use a pipe cleaner or brush in any lumens and crevices. -Actuate any moving parts to loosen trapped contaminants. -Rinse in warm (38-49oC) water for 1 minute. Thoroughly flush all lumens & other difficult to reach areas. Actuate while rinsing. -Ultrasonically clean the instruments for 10 minutes in a neutral pH detergent per manufacturer’s instructions. -Rinse with final rinse water quality of reverse osmosis or distilled water, actuating any moving parts while rinsing for 1 minute. Repeat rinse twice. -Dry instruments thoroughly with a clean, lint free cloth. Execute the cycle using a pH neutral enzymatic detergent according to the following parameters: Step 1: Pre-Wash: Minimum Temperature: Cold Tap Water Minimum cycle time: 2 minutes Step 2: Enzyme Wash: Minimum Temperature: Hot Tap Water Minimum cycle time: 4 minutes Step 3: Wash (Detergent % according to manufacturer specification): Minimum Temperature: 65.5 °C (149.9°F) Minimum cycle time: 2 minutes Step 4: Neutralization: Minimum Temperature: Hot Tap Water Minimum cycle time: 2 minutes

Visual Inspection

Sterilization Preparation

Sterilization

Storage

Step 5: Rinse: Minimum Temperature: Hot Tap Water Minimum cycle time: 15 seconds Step 6: Thermal Rinse (A0 = 3000): Minimum Temperature: 82.2 °C (180.0°F) with Lubricant (% Lubricant according to manufacturer specification) Minimum cycle time: 1 minute Step 7: Hot Air Dry: Minimum Temperature: HIGH Minimum cycle time: 6 minutes -Inspect instruments for any damage or remaining contaminants, devices must be visually clean and without visual contaminants. -Repeat cleaning if contamination remains. -Contact OMNIlife science if instruments are damaged. -Place instruments in the correct location in the instrument pan. -Do not stack pans for sterilization -Wrap the pan in a double layer of FDA cleared CSR wrap. OR -Place instruments into a SterilContainer -Pre-vacuum cycle -Temperature: 132oC or 270oF -Exposure time: 4 minutes -Dry time: 40 minutes Store wrapped or in SterilContainer prior to immediate use.

STORAGE Store instruments in the corresponding instrument system pans. After use and cleaning, instruments must be stored in a clean, dry and temperate place. EXAMINATION PRIOR TO USE All instruments should be carefully examined for wear or damage by surgeons and staff in operating centers prior to surgery. The examination shall include a visual and functional inspection. It should also include verifying the cleanliness of the device, as well as the absence of any cracks, distortion, wear, corrosion, or other change. Like any precision surgical device, all instruments should undergo regular checks by knowledgeable personnel to ensure that they remain in good condition and continue to act as intended. Do not use any instrument or device that is damaged, incomplete, showing signs of excessive wear and tear, or that has been repaired outside the control of OMNIlife science.