U.S. Patent No. 7,641,873
The TD 100 delivers high level disinfection to TEE probes in ONLY 5 minutes. The TD 100 disinfects each TEE probe with High-level disinfectant and provides printed verification upon completion of successful disinfection cycle. Microprocessor-controlled, the TD 100 is simple to use for any health care professional reprocessing a used TEE ultrasound probe.
The TD 100 dramatically reduces the amount of stress and the potential for damage to TEE probes. The system was designed with every aspect of the TEE probe taken into consideration. The control handset is held securely within the TD 100, while strain and stress is minimized from the cable and electronic pack adapter with a specially designed hanger and mounts for both.
The TD 100 has improved my department's TEE probe cleaning, documentation, and time my staff used to spend processing a probe. With the TD 100, documentation is made easy while turn over-time is much faster at the same time meeting regulatory requirement.
Additionally, the height to insert the TEE probe distal tip and shaft is only 38", giving less potential of hitting and damaging the distal tip during insertion into the TD 100.
The TD 100 suspends the TEE probe in a custom fitted bracket that holds the control handle securely while the insertion shaft of the probe is placed within the disinfection reservoir for high-level disinfection. The TD 100 is designed to prevent oversoaking as this is the second leading reported damage to TEE probes beyond being dropped or struck by another object. Manual reprocessing can expose your TEE probes to this type of expensive damage.
The following is a manufacturer’s warning for TEE probes:
Do not use a transducer that has been dropped or struck against another object. The transducer is fragile and will break ... this is not covered by the probe warranty or service contract.
The TD 100 generates significant savings both in labor time and cycle time. The device setup requires less than one minute of operator interaction, while the whole disinfection and rinse cycle is completed in less than 17 minutes. The TEE ultrasound probe is held within the disinfection reservoir and once the cycle starts the staff member can resume other duties while the TD 100 reprocesses the probe. The TD 100, with the advanced vapor management system, can be installed near the TEE procedure room. This will allow for minimal transportation of the delicate probes for reprocessing. When compared to manual reprocessing, the TD 100 allows more procedures with the same probe, while reducing stress and potential damage to probes.
After inserting an enzymatically cleaned and properly dried TEE probe into the TD 100, you simply follow the clear prompts on the display. This takes less than one minute to enter operator and probe details that will be printed on the verification report along with the contact time and average disinfectant temperature at the completion of a successful disinfection cycle. The TD 100 automatically continues the process of high-level disinfection followed by five cold water rinses for a total of 17 minutes of reprocessing time. When comparing that to the labor intensive manual process for disinfection and rinsing the TD 100 is extremely efficient and provides a repeatable result. Additionally, the high-level disinfectant used in the TD 100 is single-use and does not require the staff member to use an MRC test strip on the solution to confirm efficacy prior to high-level disinfection.
The TD 100 performs continuous self-diagnostic tests that confirm the result in a printed report after each cycle. The successful disinfection record contains the date, time, disinfectant lot number, disinfectant contact time, average disinfectant temperature and both the operator and probe identification. The verification ticket can be recorded in the HLD TRACKER provided by CS Medical for audit purposes. If needed, additional copies of the record can be printed directly from the device and used to accompany the disinfected TEE ultrasound probe to the procedure room. The HLD TRACKER can also be used to document electrical leakage testing results as well as pertinent patient information.
The TD 100 utilizes a dedicated single-use 16 oz. bottle of disinfectant. The high-level disinfectant container seal is opened inside the machine. The TD 100 was engineered with an advanced vapor management filtration system that adsorbs and neutralizes vapors released during the high-level disinfection process. Splashes and spills are trapped within the disinfectant reservoir while the fumes are captured by the advanced vapor management system to minimize operator exposure. The TD 100 uses a fresh bottle of high-level disinfectant each cycle eliminating the need for a health care professional to conduct MRC testing and have the potential of exposure to the high-level disinfectant vapors. The TD 100 was engineered to provide unsurpassed operator safety from exposure to high-level disinfectant vapors.
Upon completion of the disinfection cycle, the TD 100 automatically pumps the high-level disinfectant to drain and eliminates the potential for over-soaking the TEE probe. The high-level disinfected TEE probe is rinsed effectively to remove the potential of OPA or Glutaraldehyde residue that could cause other issues in subsequent procedures.
The TD 100 is only 8" deep, 24" wide, and 44" high. It can be placed close to where you use your probes without taking up excessive space needed with manual reprocessing.
Chemisorptive bonded filters eliminate exposure to harmful fumes and vapors associated with high-level disinfectant. The filters adsorbs and neutralizes fumes and vapor effectively. The activated carbon filter has a weight of 19lbs.; an amount that is required to provide ample residence time and carbon to capture the fumes generated during the HLD process.
The TD 100 automated disinfector is designed to provide high-level disinfection of Transesophageal ultrasound probes. The system has been cleared for use with TD 5 and TD 8 high-level disinfectants. These products have been cleared under 510(k) number K160921. TD 100 and TD-8 have CE Marking Approval Certificate Number 630458.
The TD 100, TD-5 and TD-8 have been evaluated by individual TEE probe manufacturers. Please consult each manufacturer's care card for specific approvals.
See CS Medical products in action
The CS-TD-100RS or CS-TD-100RS8 is a complete installation that includes:
- -A refurbished TD 100
- -Pre-installation and starter kits
- -Vapor management kit
- -One case of 32 bottles of high-level disinfectant
- -Device final acceptance and staff in-service training
- -5 user licenses for the Web-Based In-Service Training
Once the pre-installation work is complete, a trained CS Medical service technician will arrive at your facility and complete the final installation and acceptance of the device followed by a training session to show staff how to use and maintain the device.
Each CS-TD-100RS or CS-TD-100RS8 has been reliably refurbished with complete traceability and then re-deployed to meet all FDA regulations for the refurbishment of medical devices. CS Medical operates a completely controlled ISO 13485:2016 and FDA compliant manufacturing environment.
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