Models 2200 and 2300 Reprocessing Console Instructions

Reprocessing of Console according to EN ISO 17664:2004 Manufacturer: Method: Cleaning & Disinfection Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA

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Model 2200, 2300 Devices(s): Reusable control units comprising fixed assemblies (no moving parts). WARNING: Limitations on reprocessing: INSTRUCTIONS: Point of use: Containment & Transportation: Preparation for cleaning:

WARNING: to avoid electrical shock disconnect control unit from power source before cleaning. Repeated processing has minimal effect on this instrument. End of life is normally determined by abrasion, wear and damage. Damp wipe only. Remove the excess soil and surface contamination with disposable cloth/paper wipe. No particular requirements. It is recommended that instruments are reprocessed as soon as is reasonably practical following use.

WARNING: to avoid electrical shock disconnect control unit from power source before cleaning. Automated cleaning does not apply to these instruments. See manual cleaning instructions Cleaning - Automated: below Equipment: mild detergent, clean gauze pad or lint free cloth, and clean soft brush. Cleaning: Manual Method: 1. Wipe excess soil from surface of instrument with cloth dampened with mild detergent. 2. Using the dry brush, clean the air flow vents. 3. Visually inspect for cleanliness. 4. Repeat steps 1 to 3 until visual inspection assures instrument is clean. 5. Allow unit to dry Not applicable Disinfection: Air dry at room temperature. Drying: Do not use damaged instruments. Maintenance: All instruments: Visually inspect for damage or wear. Where instruments form part of a Inspection & Function larger assembly, check assembly with mating components. Testing: No particular requirement. Packaging: Not applicable; control unit does not require sterilization. Sterilization: No particular requirement. Storage: Make sure that the areas near the power button and probe input connector are clean of Additional Information: debris. Be sure detergent does not ingress into display or other openings. See brochure for telephone and address of local representative or telephone (+1) 877-926Manufacturer Contact: 2666. NOTE: The instructions provided above have been validated by the medical device manufacturer as being capable of preparing a medical device for re-use. 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-000712