FAQ

Frequently Asked Questions

Overview

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.

Q: How long does it take for the TD 100® to disinfect a TEE/TOE probe?

A: 5 minutes

Q: Can the TD 100 disinfect other ultrasound probes or endoscopes?

A: No, the TD 100 is only FDA cleared for TEE/TOE probes.

Q: Does the TD 100 use OPA as an approved high-level disinfectant?

A: Yes, It is trademarked as TD-8® and is single-use with no MRC testing required.

Q: What is the difference between TD-5 and TD-8?

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.

Q: Is TD 100 and TD-5 or TD-8 approved by the TEE/TOE Ultrasound Probe manufacturers?

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.

Q: Does the TD 100 have different software programs for TD-5 and TD-8?

A: No, both chemistries have the same IFU so the same machine can use either chemistry.

Q: Does the TD 100 store data?

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.

Q: How does the TD 100 handle fumes and vapors?

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.

Q: What is the shelf life of the TD-5 or TD-8?

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.

Q: Do I need to neutralize the TD-5 or TD-8 before it is sent to waste?

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.

Q: How do I disinfect the TPorter®?

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.

Q: Does the TD 100 clean the TEE/TOE probe?

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.

Q: Why do I need to use the QwikDry®?

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.

Q: Does the TD 100 need special ventilation for installation?

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.

Q: How many TEE/TOE probes can the TD 100 disinfect?

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.

Q: Is water and electric required for operation of the TD 100?

A: Yes, cold potable water regulated at 20-25 psi and a 15 Amp GCFI outlet.

Q: Does the TD 100 record high-level disinfection contact time and temperature?

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.

Q: How does the TD 100 handle disinfection record management?

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.

Q: Is bedside cleaning and cleaning the same?

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.

Q: How tall does the technician have to be to use the TD 100?

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.

Q: What is the width of the TD 100 and how much space do I need to install the TD 100?

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.

Q: How much overall floor space does the TD 100 require?

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.

Q: Who performs the installation and final acceptance of the TD 100?

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.

Q: Can I use the TPorter to transport other probes and scopes to central services?

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.

Q: How do I clean the foam pad in the bottom of the CleanShield® Probe Storage Cabinet?

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.

Q: What can I use to clean the exterior of the TD 100?

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.

Q: What temperature does the TD 100 heat the disinfectant to?

A: The TD 100 heats disinfectant to 38 degrees C and completes high-level disinfection in 5 minutes.

Q: Does the room that the TD 100 is used in have to be under negative or positive pressure?

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.

Q: How many probes can be documented in each HLD TRACKER book?

A: 200 individual records per book.

Q: How many records will the TEEClean® store in system memory?

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.

Q: Who preforms the installation and final acceptance of the TEEClean?

A: A factory trained CS Medical service technician.

Q: How many probes can the TEEClean disinfect?

A: TEEClean cleans and disinfects one soiled TEE probe per cycle.

Q: What is the width of TEEClean?

A: TEEClean was designed to fix in the same space of the TD 100, all connections for water and electrical should be universal.

Q: Does TEEClean require any special training?

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.

Q: What chemical(s) can I use in TEEClean?

A: TEEClean can be operated with either TD-5 or TD-8 high-level disinfectant.

Q: What type of water filter is used by TEEClean?

A: TEEClean incorporates a 5 nanometer filter that effectively removes bacteria, viruses and endotoxins. The filter is a stand alone Class II medical device.

Q: Do I still need to preform the manufacturer cleaning of a TEE probe if I use TEEClean?

A: No, TEEClean cleans and disinfects a TEE probe.

Q: Do I have to use the TEEClean barcode scanner?

A: No, you can use the barcode scanner or the 7 inch color touchscreen to input data.

Q: Do I have to use the TEEClean touchscreen to type in information?

A: No, you can use the barcode scanner or select probes and users from a list in the memory of the TEEClean.

Q: How can I get the records from TEEClean?

A: You can download the accession reports and PM logs from TEEClean via USB.

Q: Can I only run a high level disinfection cycle in the TEEClean?

A: No, you can only run a clean and disinfect cycle together.

Q: Can I only run a cleaning cycle in the TEEClean?

A: No, you can only run a clean and disinfect cycle together.

Q: Can I put endoscopes in the TEEClean?

A: No, only TEE probes are validated to go in the TEEClean.

Q: How long is the total cycle time for the TEEClean?

A: The total cycle time for the TEEClean is less than 27 minutes.

Q: How often do I need to change the disinfectant for TEEClean?

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.

Q: How often do I need to change the TEEClean water filter?

A: The water filter needs to be changed every 90 days.

Q: Does the TEEClean remind me of my preventative maintenance?

A: Yes, the TEEClean will remind you ahead of time when different PMs are required.

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