Class 1 Device Reprocessing Instructions

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5.1. Limitation of Reprocessing Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on device´s life span and function. The life span is mainly affected by wear or damage during surgical use as well as proper care and handling techniques.  Class 1 Device Reprocessing Instructions  Black & Black Surgical, Inc. 5175 South Royal Atlanta Dr. Tucker Georgia 30084 USA Issue Date: 05.25.2022 Revision: 0 1.  Device Description  5.7. Packaging  Remove the excess soils with a disposable cloth or paper wipe promptly after any use. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning.  Equipment:  - Sterilization Wraps  Steps:  Wrap instrument in accordance with local procedures and using standard techniques such as those described in ANSI/AAMI ST77, ANSI/AAMI ST79 and ISO 11607  5.3. Preparation for Cleaning Disassembly is not required. 5.4. Manual Cleaning  Equipment:  Neutral Enzymatic Detergent Solution (e.g. Miltex EZ-Zyme )  2) Rinse the devices under running tap water to remove debris  Steps:  3) Immerse the devices in an Ultrasonic Cleaning Bath filled with Neutral Enzymatic Detergent Solution in accordance to manufacturer's specifications for 10 minutes 4) Remaining debris are to be removed using a Cleaning Brush 5) Rinse the devices under running tap water to remove debris  5.5. Automatic Cleaning  3.  Equipment:  Ultrasonic Bath  Black & Black´s devices are intended to be used, handled and managed in a healthcare setting by appropriately trained and qualified surgeons and personnel. The user is responsible for selecting the right instrument for a specific applications or surgical procedure  Contraindications  Improper handling and misuse of the devices may result in premature wear The application of excess or improper force may cause devices breakage  - Steam Pre-Vacuum or Gravity Sterilizer Cycle Type  T (C° - F°)  Pre-Vacuum  132 - 270  Time (min) 4  Gravity  132 - 270  15  5.9. Storage 1) Soak the device in an Enzymatic Cleaner for 10 minutes in accordance to manufacturer's specifications  Intended Use  The devices are contraindicated for all the intended uses other than the ones claimed by manufacturer. The devices are not to be used in contact with both central circulatory system and central nervous system.  Steps:  Cleaning Brush (e.g. Soft Bristle Brush)  Black & Black´s devices are used during general, reconstructive, and plastic surgical procedures.  4.  Equipment:  Ultrasonic Cleaning Bath  Carefully read these instructions before using B&B devices. Keep them in a safe place for future reference.  Intended User  5.8. Sterilization  Enzymatic Cleaner (e.g Miltex EZ-Zyme)  B2xxxx – B8xxxx (Representative for Art. No.)  2.  Do not use the devices if any of the above-mentioned problems are present. Discard damaged instruments  5.2. Point of Use  Black & Black Surgical has a wide range of devices with several technical features to cover the large demand for medical devices. This range includes diagnostic, therapeutic and health care devices.  These reprocessing instructions are applicable to devices labeled with REF above.  - Proper function, including but not limited to: cutting instruments should be sharp, straight instruments should not be bent, movement of hinge/joints/movable parts should be free  Alkaline Cleaner (e.g. Dr. Weigert Neodisher FA)  6.  Used Symbols for IFU and Label  Symbol for “Manufacturer”  Black & Black Surgical, Inc. 5175 South Royal Atlanta Dr. Tucker Georgia 30084 USA Tel.: 770-414-4880 Fax: 770-414-4879 Email: Web:  Symbol for “Catalog Number”  Cleaning and Disinfectant Device (Miele G 7736 CD)  Symbol for “Batch Code”  1) Immerse the devices into an Ultrasonic Bath with 0.5% Alkaline Cleaner for 15 minutes at 40 ° C.  Symbol for “Serial Number”  2) Automatic Cleaning in the Cleaning and Disinfectant Device following the steps below:  Symbol for “Consult the Instruction for Use”  2a) 1 min pre-cleaning with cold water 2b) Discharging  Steps  Store the packaged devices in a normal environmental condition free from dust, insects, vermin as well as temperature and humidity fluctuations.  2c) 3 min pre-cleaning with cold water 2d) Discharging  Symbol for “Non-Sterile ” Symbol for "Caution, consult accompanying documents” Symbol for "Do not Reuse”  2e) 5 minutes with 0,5 % Alkaline Cleaner at 55° 2f) Discharging 2g) 3 minutes Neutralization with warm Water (>40°C)  5.  Reprocessing Instructions These devices are delivered in non-sterile state. Before the first and any subsequent use, the devices must be reprocessed according to the validated reprocessing instruction described below. It is the responsibility of the user to ensure that the reprocessing is performed using appropriate equipment, materials and personnel to achieve the desired results Follow the instructions and warnings issued by the suppliers of any cleaning and equipment used Alkaline agents (pH>9) can damage products (e.g. part or devices made out of aluminum) The quality of water used to reprocess the devices are to conform to Directive 98/83/EC Washer/Disinfectors, cleaners and detergents must have a proven efficacy “FDA approved, VAH listed or CE mark”. Use of different products is under user responsibility. Do not exceed 140 °C – 284 °F throughout reprocessing steps  25-0021 USA_Class I Reprocessing Instructions  2h) Discharging 2i) 2 minutes brushing with warm Water (>40°C) 2j) Discharging  5.6. Manual and Automated Disinfection Manual: Prepare a disinfectant bath according to the instructions of the disinfectant manufacturer. Place the instruments in the disinfectant bath and observe the specified soaking time. Rinse the products thoroughly with fully demineralized water to remove the disinfectant without residue. Automatic: Machine operated thermal disinfection has to be carried out in consideration of the national requirements with regard to the A0 value (see ISO 15883). 5.6.1. Inspection and Functional Testing Black & Black´s devices must be inspected after processing and prior to sterilization for: - Cleanliness Damages, included but not limited to: corrosion, discoloration, excessive scratches, cracks and wear Page 1 of 1
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