Device Description: Atlas Spinal Implants Plates and Screws stand as indispensable instruments for addressing precise spinal conditions—ranging from fractures to fusions and osteotomies—utilizing sophisticated plate and screw fixation techniques. It's imperative to grasp that, unlike ordinary interventions, these devices don't supplant the body's natural tissue healing process; rather, they amplify and fortify this intrinsic mechanism. Meticulously crafted, the Atlas Spinal Implants not only offer additional constraint to the movement of treated spinal segments but also play a pivotal role in fortifying and stabilizing the spine during the pivotal healing phase.

Materials used: Stainless steel or Titanium

Intended Use: Atlas Spinal Implants Plates and Screws serve as implants meticulously designed for the fixation of specific spinal fractures, fusions, or osteotomies. The variability in implant size, diameter, and shape is intentional, allowing the implants to accommodate variations in patient size and specific spinal sites. These implants are manufactured from 316L medical-grade implant quality stainless steel or implantable medical-grade titanium. It is imperative to utilize Atlas Spinal Implants Plates only with the corresponding Atlas Spinal Implants Screws, ensuring the use of a compatible and comprehensive system for long-term spinal stabilization.

General handling: Exercise meticulous care in storing the product in its unopened protective packaging. Perform a thorough check for any damage to the packing before unpacking. Only unpack the implant immediately before use, and visually inspect it for any signs of damage. Never use a damaged implant, and avoid reusing any implant. Modular components are integral to a system and should only be used in conjunction with the appropriate original components from OrthoFlex. Refer to relevant brochures and product descriptions for details on specified combinations.

Packing: All components are carefully packed in protective packaging. Strict adherence to local regulations for asepsis during the removal of the implant from its packaging is paramount. The manufacturer or local distributor cannot accept returned implants except in their original, undamaged, and completely intact packaging. If the packing seal is broken or the packing is opened improperly, the manufacturer cannot be held liable.

Storage: Store the product in a dry place at room temperature. Never use the implant after its specified expiry date, if applicable.

Cleaning/Sterilization: ATLAS, products supplied in a non-sterile condition must be cleaned and sterilized prior to surgical use. Prior to cleaning and/or sterilization, remove and dispose all original disposable packaging (e.g. silicone sleeves, tip guards, pouches, bags, tubes, etc.) Component devices must be disassembled prior to cleaning, disinfection and sterilization.

Cleaning: Unused ATLAS, implants, must be processed according to the following cleaning procedures. Due to variations in conditions and environments, the user has final responsibility for the implementation and verification of procedures to achieve cleanliness.

1. Rinse the soiled device under lukewarm running tap water (22°-43°C) for a minimum of two (2) minutes. Remove gross soil using a soft-bristled brush or clean, soft, lint-free cloth. Note: Remove additional soil from challenging design features (i.e., holes, lumens, hinged/mating surfaces, interfaces, crevices, serrations) using common cleaning tools. Never use metal brushes or steel wool for cleaning.
2. Prepare an enzymatic cleaning solution using Enzol, pH detergents such as Prolystica 2X Concentrate Enzymatic Presoak as per the manufacturer's instructions.
3. Fully immerse the instruments in the fresh, newly prepared enzymatic cleaning solution and soak for twenty (20) to twenty-five (25) minutes.
4. Use a soft-bristled brush to gently clean the submerged device, paying particular attention to crevices, lumens, mated surfaces, and other hard-to-clean areas. Brush for a minimum of 15 seconds or longer if needed to remove debris. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e., pipe cleaner brush) if needed to remove debris. Note: The enzyme solution should be changed when it becomes grossly contaminated (bloody and/or turbid).
5. Remove the device from the cleaning solution and rinse with lukewarm, running tap water (22°-43°C) for a minimum of one (1) minute. After rinsing, ensure debris is removed from the instrument. If debris remains, use a syringe to flush the device or repeat rinsing until debris is removed.
6. Prepare an enzymatic cleaning solution, Prolystica 2X Concentrate Enzymatic Presoak, according to the manufacturer's instructions. Place all devices within a container with the enzymatic cleaning solution and place the container in the sonication unit.
7. Fully immerse the device in the fresh, newly prepared enzymatic cleaning solution. Actuate the joints, handles, and other movable device features to expose areas to the cleaning solution several times. Sonicate for ten (10) to fifteen (15) minutes.
8. Fully immerse the device in a basin with clean lukewarm tap water (22°-43°C) for rinsing. Gently agitate the device for a minimum of one (1) minute. Actuate the joints, handles, and other movable device features to expose areas to the water several times. Pass a soft-bristled brush through any crevices or lumens.
9. Repeat steps 7 and 8 with a freshly prepared cleaning solution if there is a sign of blood or soil in the tap water bath.
10. Remove the devices from the rinse solution and rinse with lukewarm, running tap water (22°-43°C) for a minimum of one (1) minute. After rinsing, ensure debris is removed from the instrument. If debris remains, use a syringe to flush the device or repeat rinsing until debris is removed.
11. Dry the device using a clean, soft, lint-free cloth or clean compressed air. Visually inspect the device; no visible soil should be left on the device. Note: Thorough drying of devices prevents corrosion from mineral content, condensate, and residual agents.

Sterilization: ATLAS recommends the following sterilization procedures for non-sterile implants and reusable instruments. Due to variations in conditions and environments, the user has final responsibility for the implementation and verification of procedures to achieve sterility.