Model 1013 Collimator Autoclave Reprocessing Instructions

Autoclave Reprocessing of collimators according to EN ISO 17664:2004 Manufacturer: Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 US

Method: Steam Sterilization (Autoclave)

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Model 1013 Devices(s): All reusable collimators supplied by Devicor Medical Products, Inc. comprising fixed assemblies (no moving parts). WARNING: Limitations on reprocessing: INSTRUCTIONS: Point of use: Containment & Transportation: Preparation for cleaning: Cleaning - Automated: Cleaning: Manual

Do Not exceed 150ºC for collimators during cleaning or drying cycles. Repeated processing has minimal effect on these accessories. End of life is normally determined by abrasion, wear and damage due to use. Detach the collimator from the probe. Remove the excess soil and surface contamination with disposable cloth/paper wipe. No particular requirements. It is recommended that collimators are reprocessed as soon as is reasonably practical following use. Detach the collimator from the probe. Automated cleaning does not apply to these collimators. See manual cleaning below. Equipment: enzymatic detergent, brush, running water. Method: 1. Rinse outside surfaces with brisk stream of water. Wipe with soft cloth soaked with enzymatic cleaner suitable for surgical collimators 2. Visually inspect collimator for contaminated areas. 3.

Repeat Steps 1 and 2 until visual inspection reveals collimator is clean.

4.

Rinse with a brisk stream of water for 30 seconds and dry with clean soft cloth.

5. Repeat steps 1 to 4 until visual inspection assures collimator is clean. Disinfectant solution may be used in accordance with label instructions. Disinfection:

Drying: Maintenance: Inspection & Function Testing: Sterilization:

WARNING: to avoid health hazards comply with the disinfectant manufacturer’s instruction. 1. Prepare mixture according to manufacture’s instructions. 2. Apply mixture for at least 5 minutes but not more than 20 minutes. Cover all area including niches and joints. 3. Rinse with brisk stream of tap water for approximately 30 seconds and dry with clean soft cloth. When drying is achieved as part of disinfection cycle, do not exceed 150ºC. Do not use damaged collimators. All collimators: Visually inspect for damage or wear. Where collimators form part of a larger assembly, check assembly with mating components. Steam Autoclave: 1. Process at 132ºC for 4 minutes. 2. Processing at 134ºC for 18 minutes is preferred in Europe. No particular requirements.

Storage: Additional When sterilizing multiple collimators or accessories in one sterilizer, do not exceed the sterilizer’s maximum capacity. Information: Manufacturer Contact: See brochure for telephone and address of local representative or telephone (+1) 877-926-2666. NOTE: The instructions provided above have been validated by the medical device manufacturer as being capable of preparing a medical device for reuse. It remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed using equipment, materials, and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

AW-000710