The Custom Ultrasonics Scope-Assist Flushing Sink is a specialized device designed for the cleaning and reprocessing of endoscopes. It facilitates a comprehensive cleaning process, preparing endoscopes for high-level disinfection or sterilization. The sink is available in two models, S6 and S8, which share core functionalities but differ in dimensions and installation requirements.
Function Description:
The Scope-Assist Flushing Sink provides a controlled environment for the manual cleaning of endoscopes. Its primary function is to flush the internal channels of endoscopes with detergent solution and rinse water, as well as to clean the exterior surfaces. This process is critical for removing bioburden and ensuring the efficacy of subsequent disinfection or sterilization steps. The sink incorporates a variety of features to achieve this, including:
- Detergent Delivery System: A dedicated system for dispensing and circulating detergent solution through endoscope channels. This includes a detergent pump, detergent solenoid, and a detergent bottle. The system is designed to provide a consistent flow of detergent for effective cleaning.
- Rinse Water System: A system for delivering and circulating rinse water to flush detergent from endoscope channels and surfaces. This includes a rinse/purge tee, rinse solenoids, and a water pressure regulator to ensure optimal flow and pressure.
- Channel Flushing Ports: Multiple ports designed to connect to various endoscope channels, allowing for simultaneous flushing and rinsing. The sink is compatible with a range of channel adapters to accommodate different endoscope types.
- Hand Spray: A hand spray for manual cleaning of the endoscope's exterior surfaces and the sink basin.
- Pop-Up Drain Handle: A mechanism to control the draining of the sink basin.
- Overflow Drain: Prevents the sink from overflowing.
- Gooseneck Faucet: Provides hot and cold water for general use.
- Intake Screen: Filters debris from the water intake.
- Control Panel: Allows the operator to manage the various functions of the sink, including activating the detergent and rinse cycles.
- Purge System: A system to clear air from the endoscope channels and ensure proper fluid flow.
The sink is designed to be user-friendly, with clear controls and indicators to guide the operator through the cleaning process. It aims to standardize the manual cleaning step, reducing variability and improving the overall safety and effectiveness of endoscope reprocessing.
Important Technical Specifications:
The Scope-Assist Flushing Sink is manufactured in compliance with Quality System Regulations per 21 CFR 820 requirements and is an FDA registered and ISO 13485 certified medical device.
Model S6 Dimensions:
- Total Height: 50 1/2 inches
- Deck Height: 36 5/8 inches
- Width: 32 inches
- Faucet Height: 13 1/2 inches
- Basin Length: 26 inches
- Basin Depth: 7 inches
- Drain Height (OC): 22 inches Max, 18 inches Min
- Toe Kick Height: 5 3/8 inches
- Toe Kick Depth: 3 1/4 inches
- Toe Kick Width: 25 inches
Model S8 Dimensions:
- Drop-In Length: 33 inches
- Drop-In Width: 22 inches
- Drop-In Height: 18 inches
- Drain Height (OC): 22 inches Max, 20 inches Min
Water Supply Requirements:
- Plumbing configurations must follow state and local codes.
- NSF/ANSI-61 or NSF-PW certified minimum 1/2" copper, PVC, CPVC, etc. water supply lines.
- Water pressure must be between 40 and 60 PSI.
- Water hardness must be less than 120 ppm or 7 gpg (CaCO3).
- The faucet requires 1 hot and 1 cold supply line terminating with 1/2" compression shut-off valves.
- The cold water rinse line requires 1 cold supply with a reduced pressure zone backflow preventer terminating with a 3/4" compression shut-off valve.
Waste Drain Requirements:
- A drain system with a minimum 1 1/2" standard connection that is less than 22" above the floor.
- SAFS Model S6: Connection must be between 18" and 22" on center (OC) above the floor.
- SAFS Model S8: Connection must be between 20" and 22" on center (OC) above the floor.
Electrical Supply Requirements:
- A 120 VAC (±10%), single phase, 60Hz, 15A circuit.
- A NEMA 5-15R, GFCI, protected outlet located within the operator's reach.
Detergent:
- The device is factory preset for dosing and delivery of Tergal® 800 Detergent. Tergal® 800 Detergent is a low foaming, versatile, free rinsing detergent. It does not contain any enzymes that require specific temperatures for time and temperature to be effective.
Usage Features:
The Scope-Assist Flushing Sink is designed for ease of use and to promote adherence to reprocessing guidelines. Key usage features include:
- Step-by-Step Operation: The manual outlines a clear, sequential process for water inlet, drainage, detergent system, purge system, and rinse system operation. This ensures that operators follow the correct steps for effective cleaning.
- Channel Adapters: The sink utilizes channel adapters (P/N 18000) to connect to endoscope channels, ensuring a secure fit and efficient fluid delivery.
- Visual Indicators: The detergent system includes LED lights that illuminate when the detergent system is activated and when detergent exits the detergent baffle in the sink basin, providing visual confirmation of proper operation.
- Water Pressure Regulator: Allows for adjustment of water pressure to ensure optimal flow for flushing and rinsing.
- Safety Warnings: The manual emphasizes the importance of personal protective equipment (PPE) and provides warnings regarding potential hazards such as electrical shock, chemical exposure, and improper operation.
- Error Prevention: Features like the overflow drain and clear operational steps help prevent common errors during the cleaning process.
- Compatibility: The sink is designed to be compatible with various endoscope types and channel configurations through the use of appropriate adapters.
Maintenance Features:
Regular maintenance is crucial for the optimal performance and longevity of the Scope-Assist Flushing Sink. The manual provides a detailed maintenance schedule and instructions for various tasks:
- Daily Maintenance: Includes operator's daily checklist, daily cleaning and decontamination procedures, and performing the adapter decontamination procedure.
- Operator's Daily Checklist: Verifying the sink basin, water scale, plumbing, power cable, control panel, faucet, and hand spray.
- Daily Cleaning and Decontamination: Cleaning and disinfection of the sink basin and countertop areas, and performing the adapter decontamination procedure using Clorox® Germicidal Bleach (8.25%).
- Quarterly Maintenance and Inspection: Includes visual inspection of the sink, intake screen inspection, adapters and channel flushing port inspection, and solenoid inspection.
- Visual Inspection: Checking sink channel adapters, water scale, plumbing, power cable, control panel, faucet, and hand spray.
- Intake Screen Inspection: Checking for metal intake screen integrity and cleaning debris.
- Adapters and Channel Flushing Port Inspection: Inspecting endoscope adapters and channel flushing ports for wear, obstruction, and damage.
- Solenoid Inspection: Detailed procedure for inspecting the green plunger and brown O-ring of the solenoid for wear or damage, and replacement if necessary.
- Annual Maintenance and Inspection: Includes replacing female quick-disconnect bulkheads (P/N 18022) on the channel flushing ports and performing quarterly maintenance and inspection.
- Detergent Pump Poppet Valves: Instructions for inspecting and replacing the poppet valves and O-rings in the detergent pump if damaged or worn.
- Water Pressure Regulator: Instructions for checking and adjusting the water pressure regulator to ensure it operates within the specified range (40-50 PSI).
- Disc Filter Replacement Log: A log to track the replacement of the in-line disc filter (P/N 16030), which should be replaced every six weeks from the install date or if flow is restricted.
The manual also provides contact information for ordering replacement parts and supplies, and for customer service inquiries. It emphasizes that only Custom Ultrasonics OEM components should be used to ensure proper performance and compliance.
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