As the leading developer, manufacturer, and marketer of medical devices designed to provide high-level disinfection of ultrasound TEE/TOE probes, CS Medical continues to innovate through superior technologies and products. We are committed to providing the best possible solutions for infection prevention that support healthcare professionals worldwide.
CS Medical goes beyond high-level disinfection of TEE/TOE probes, CS Medical believes in managing the quality of care given to delicate TEE/TOE probes. Our TEE Complete Care® offering provides solutions for the healthcare facility to minimize TEE/TOE ultrasound probe damage and reduce the potential of contaminating high-level disinfected probes prior to use. These products address the following areas: bedside cleaning, electrical leakage testing, drying, transporting and storing the TEE/TOE ultrasound probe. Our objective is to manage the care given to each TEE/TOE probe thus allowing for a reduction in healthcare associated infections.
A: 5 minutes
A: No, the TD 100 is only FDA cleared for TEE/TOE probes.
A: Yes, It is trademarked as TD-8® and is single-use with no MRC testing required.
A: Both are aldehydes; Glutaraldehyde (TD-5) and OPA (Ortho-phthalaldehyde) (TD-8). They both have the same IFU for use in the TD 100. Both provide 5-minute high-level disinfection per probe.
A: Yes, both the machine and the chemistries have been evaluated and approved by Philips Healthcare, GE HealthCare and Siemens. Contact the individual probe manufacturer for your specific model details.
A: No, both chemistries have the same IFU so the same machine can use either chemistry.
A: No, the TD 100 does not store data but at the conclusion of a successful disinfection a written printout is provided with time, date, operator ID, probe ID, chemical type, lot number, serial number, run number, contact time and contact temperature. If the machine does not complete the high-level disinfection, another print out is produced to indicate high-level disinfection has not occurred and diagnostic details of the aborted cycle are provided. The print out can be stored in the HLD TRACKER™ which holds 200 records per record book. Additionally, the HLD TRACKER allows for documentation of the electrical leakage testing and any other patient details desired by the healthcare facility.
A: An advanced bonded carbon vapor management filter is incorporated inside the main device where all fumes or vapors are captured and neutralized. The vapor management filter has been tested and will last 12 months from the date of installation. Due to the molecular weight of aldehydes, a good mass of carbon is needed to effectively adsorb the fumes. Residence time within the filter is critical as well as carbon mass.
A: Either chemical will have the correct MRC to complete high-level disinfection of a TEE/TOE probe for 12 months from the date of manufacturing.
A: This depends on multiple factors. Does your hospital have a method for handling untreated waste before entering into the municipal water supply? What are the requirements or regulations by your municipal water supply in relation to untreated waste? Typically, all waste that is sent to a municipal water supply must be treated due to the potential harm it can cause the overall water system.
A: The IFU outlines methods for incorporating both a betweeen-use surface disinfectant with a more intensive monthly disinfection through low temperature sterilization. Consult the IFU for complete details.
A: No, the TD 100 is only designed to high-level disinfect a TEE/TOE probe after it has been properly bedside and manually cleaned per TEE/TOE manufacturers' direction.
A: QwikDry is effective in removing moisture from the TEE/TOE probe shaft after high-level disinfection has occurred. A wet probe can capture airborne particulate present in the environment and contaminate the TEE/TOE probe. Storage of a wet TEE/TOE probe can lead to contamination via waterborne bacteria. A properly dried TEE/TOE probe is critical in all aspects of the reprocessing cycle.
A: No, the TD 100 is much like a filtered or ductless hood. The TD 100 has a built-in vapor management system that effectively captures any high-level disinfectant vapor.
A: The TD 100 is designed to high-level disinfect one TEE/TOE probe in five minutes followed by five cold water rinses. The total cycle time for the TD 100 is 17 minutes. When reviewing the total process time from patient extraction to high-level disinfection you will note the work flow requires about 15 minutes to properly bedside clean, enzymatic soak for cleaning and rinse prior to high-level disinfection.
A: Yes, cold potable water regulated at 20-25 psi and a 15 Amp GCFI outlet.
A: Yes, the successful high-level disinfection print out records the following data for retention and can be affixed to the HLD TRACKER: Date, Time, Operator ID, Probe ID, HLD Type, Contact Time, Contact Temperature, HLD Lot number, Serial Number and Run Number.
A: The TD 100 provides a printed ticket at the conclusion of every cycle; successful or aborted. The ticket can be affixed to the HLD TRACKER sheet for later audit or verification purposes. In addition, the HLD TRACKER allows the technician to verify an electrical leakage test was performed on the TEE/TOE probe and then document the results of this test. HLD TRACKER aids in the proper handling of the TEE/TOE probe though documentation of electrical leakage testing and high-level disinfection.
A: No, bedside cleaning is done when the TEE/TOE probe is removed from the patient's mouth. The use of an enzymatic with an applicator is required to begin the process of removal of inorganic and organic matter that can dry on the TEE/TOE probe and result in biofilm being formed. Cleaning, also known as the manufacturers' recommended cleaning method, is performed prior to high-level disinfection. This process utilizes an enzymatic solution in the form of a bath. This process allows the probe to soak for 2-3 minutes before removing, rinsing and then drying.
A: The TD 100 overall height is 44 inches but the point at where insertion of the distal tip and shaft is only 38 inches.
A: The TD 100 is 24 inches wide and has all the services on the left side of the device to include; power, intake water, discharge waste line and air filter exhaust. Typically, an additional 12 inches is desired to allow for easy setup and maintenance but less has been done depending on specific facility requirements.
A: The foot print of the TD 100 is 24 inches wide and 8 inches deep. Depending on operator or overall work flow functional space will vary. The TD 100 is mounted to the wall by four specialized brackets.
A: A factory trained CS Medical service technician completes the final onsite installation, conducts a performance verification of the device and trains staff on the safe operation and scheduled maintenance for the device prior to hand off of the TD 100 to the healthcare facility.
A: No, the TPorter is designed only for TEE/TOE probes with special compartments to protect and hold all aspects of the TEE/TOE probe safely and securely during transport.
A: The foam is easily removed for surface disinfection. The foam pad is closed cell and will not adsorb moisture or foster bacteria growth. An approved surface disinfectant should be used to ensure material compatibility.
A: CS Medical has validated one hard surface disinfectants for use on the exterior of the TD 100. Solucide® is approved and will not cause damage to the device.
A: The TD 100 heats disinfectant to 38 degrees C and completes high-level disinfection in 5 minutes.
A: The TD 100 is self venting through bonded carbon filtration that captures any vapors generated during the disinfection and rinse cycles. It operates like a ductless hood as outlined in AAMI/ANSI ST.58. The TD 100 does not require either a positive or negative pressure room. Local, state and federal guidelines should be followed for room ventilation requirements.
A: 200 individual records per book.
A: 15,000 records are retained in systems memory of TEEClean and can be recalled to print or download in a variety of time segments.
A: A factory trained CS Medical service technician.
A: TEEClean cleans and disinfects one soiled TEE probe per cycle.
A: TEEClean was designed to fix in the same space of the TD 100, all connections for water and electrical should be universal.
A: A factory trained CS medical service technician will provide end user training at the conclusion of the installation and final acceptance testing of the TEEClean.
A: TEEClean can be operated with either TD-5 or TD-8 high-level disinfectant.
A: TEEClean incorporates a 5 nanometer filter that effectively removes bacteria, viruses and endotoxins. The filter is a stand alone Class II medical device.
A: No, TEEClean cleans and disinfects a TEE probe.
A: No, you can use the barcode scanner or the 7 inch color touchscreen to input data.
A: No, you can use the barcode scanner or select probes and users from a list in the memory of the TEEClean.
A: You can download the accession reports and PM logs from TEEClean via USB.
A: No, you can only run a clean and disinfect cycle together.
A: No, you can only run a clean and disinfect cycle together.
A: No, only TEE probes are validated to go in the TEEClean.
A: The total cycle time for the TEEClean is less than 27 minutes.
A: The disinfectant for the TEEClean is single use with TD-5 or TD-8 and thus a new bottle is used for every TEE probe.
A: The water filter needs to be changed every 90 days.
A: Yes, the TEEClean will remind you ahead of time when different PMs are required.
A: Yes, CS Medical products, TD 100, TD 200 and TEEClean are all HIPAA compliant. Our devices do not retain any Protected Health Information nor individually identifiable health information. Our devices only retain performance data to aide in the demonstration of device performance. The TD 100 and TD 200 provides printed information on device performance while the TEEClean offers both printed and a system download to USB of performance data.
A: Internal ultrasound probes are classified as semi-critical devices (e.g. vaginal, rectal and transesophageal). Internal probes require pre-cleaning at point of use and cleaning, rinsing, drying and high-level disinfection between each patient use.
A: The physical removal of foreign material (dust, soil) and organic material (blood, secretions, excretions, microorganisms) is essential. Rather than killing microorganisms, cleaning physically removes them. Before high-level disinfection can occur and be effective, cleaning must be performed.
A: An enzymatic cleaner is designed to breakdown proteins such as blood, body fluids, secretions and excretions from surfaces and equipment. Enzymatic cleaners are used to loosen and dissolve organic substances.
A: High-level disinfection is a process capable of killing vegetative bacteria, mycobacteria (including Mycobacterium tuberculosis), fungi, and lipid and non-lipid viruses. HLD may kill some (but not necessarily high numbers of) bacterial spores. It is critical for medical devices to be thoroughly cleaned prior to high-level disinfection.
A: The minimum concentration of a liquid chemical disinfectant that achieves the claimed microbial activity.
A: IFU (information for use) and MIFU (Manufacturer's instruction for use) should be obtained from individual medical device manufacturers and they should provide detailed information on which disinfectants and cleaners are compatible.
A: Pre-cleaning prevents soils from drying on devices. Immediately after use, the user shall clean medical devices of gross soil by rinsing with water and wiping with an enzymatic solution or a water-moistened low-lint cloth. The presence of soil can lead to a more difficult method of reprocessing ultrasound probes.
A: An ultrasound probe is a complex, fragile, highly specialized medical device that requires particular care in its cleaning and handling. They are used in various clinical settings including, but not limited to: operating rooms, diagnostic imaging, emergency departments, ambulatory clinics, and physician's offices.