(271 days)
K0903641
Not Found
No
The description focuses on automated ozone disinfection cycles and system control, with no mention of AI or ML technologies. The performance studies validate reliability, disinfection efficacy, and software functionality, none of which indicate the use of AI/ML.
No
The device is used for disinfecting the water distribution system in a dialysis facility, not for treating patients.
No
This device is a disinfection system for water distribution in dialysis facilities, not a diagnostic device. It is used to reduce bioburden and maintain water quality, not to diagnose a condition or disease.
No
The device description and performance studies clearly indicate the device includes hardware components such as a water storage tank, ozone generator, and a distribution loop, in addition to software.
Based on the provided information, the TANGO3 Water Storage Tank with Ozone Disinfection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the disinfection of the water distribution system within a dialysis facility. This is a process related to maintaining the quality of water used in a medical procedure, not for performing diagnostic tests on biological samples.
- Device Description: The device description focuses on the mechanical and chemical process of using ozone to disinfect water and the system for distributing and rinsing this water. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays to detect specific analytes
The TANGO3 is a system for maintaining the quality of water used in a medical setting, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
Product codes (comma separated list FDA assigned to the subject device)
FIN
Device Description
The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the distribution loop. The solution is recirculated throughout the distribution system. To complete the disinfection process, the system and distribution loop are then rinsed with adequate water. The described process is accomplished with 4 consecutive 30 minute cycles of ozone disinfection weekly. In addition, a disinfection cycle of 45 minutes multiple times per week may also be used for additional reduction of bioburden (as determined by user facility monitoring). After disinfection TANGO3 will leave the distribution loop with less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
The TANGO3 Water Storage Tank with Ozone Disinfection System consists of the following components: a heat regenerative desiccant air dryer at a 20 SCFH of air flow, a Corona discharge ozone generator that produces a working concentration of 0.3ppm of ozone, a venturi based injection system, HDPE or Stainless Steel water storage tank, an off gas ozone destruct system, a multi-stage centrifugal distribution pump (duel distribution pumps are offered as an option), and a main controller and operator's interface. Sensors incorporated into the system include return and output flow sensors, an ozone sensor, a level sensor, a conductivity sensor, and an atmospheric ozone detector. Fluid contacting materials include: Stainless Steel 300 Series, High Density Polyethylene (HDPE), Lexan® (Polycarbonate), Acrylic (PMMA), Teflon® (PTFE), Viton® (FKM), Kynar® (PVDF), and PVC. The System produces a dissolved ozone concentration of 0.20 ppm to 0.30 ppm during the disinfection process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dialysis facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reliability Validation Testing: Reliability testing has been conducted to ensure that all components of the system function as designed for the intended life of the TANGO3. This testing included a validation of the software functions, including alarms. The system was tested to simulate 10 years of use. All tests passed and demonstrated that the device works as intended, including O3 generation capability (O3 level between 0.2 ppm and 0.3 ppm), O3 Calibration (No variation greater than 5%), Valves and dissolved ozone destruct (No valve related alarms should be observed, Level of ozone not above 0 ppm), Pump (Loop velocity maintained at 4 ft/sec ± 10%), Ambient ozone (Ambient ozone readings on both automated ozone detector and badge), and FMEA (Validate that a failure of critical components will be detected).
Disinfection Validation: Testing was conducted to validate the disinfection performance of the ozone generator when used for water disinfection for dialysis and to determine the efficacy of O3 to disinfect water to below contamination action levels (bacteria and LAL). Overall, results of the disinfection validation show that the disinfection effectiveness of TANGO3 while keeping the water in the dialysis water distribution loop below AAMI RD 62:2006 action levels. Organisms tested included Acidovorax, Pseudomonas Aeruginosa, Burkholderia Cepacia, Brevundimonas Diminuta, Mycobacterium Fortuitum for the disinfection of clinically relevant waterborne bacteria and normal inoculation (simulated use) testing. Acidovorax Pseudomonas Aeruginosa Burkholderia Cepacia were tested for Biofilm Reduction and Prevention Capability Testing. Poliovirus Type 1, Rotavirus, Herpes Simplex Virus Type 1 were tested for Elimination of Enveloped and Non-enveloped Viruses. Candida Tropicallis Aspergillus were tested for Fungi Elimination Efficacy.
Field Testing: Field testing was performed in four (4) dialysis facilities with histories of water contamination. All four (4) facilities had documented water contamination issues and required periodic disinfection processes in order to maintain total bacterial counts and endotoxin levels below AAMI recommendations. This testing was conducted under a standard protocol, which was reviewed and approved by the Institutional Review Board (IRB) of the facility at which the testing was conducted. The IRB determined that the testing was to be non-significant risk. Disinfection with the TANGO3 System was performed based on the clinic's policies and procedures. Results show that TANGO3 was able to maintain the water in the distribution loop below AAMI RD 62:2006 action levels.
Software Verification and Validation Testing: Complete software validation, verification, and performance testing was performed to confirm that the features worked correctly and that the Programmable Logic Controller, the Human Machine Interface, and the Ozone systems hardware functioned together as expected. Documentation was provided as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern since, prior to mitigation of hazards, a failure of the software could result in Minor Injury, either to a patient or to a user of the device.
Human Factors Testing: Human factors testing was conducted to verify that the user can safely operate the TANGO3. Different ranges to set up parameters were entered, and the readability of screens and messages was evaluated. Proper recognition of visual and audible alarms was also verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K0903641
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2015
TANGO3, LLC C/O Ms. Lori Holder Regulatory Affairs Consultant 141 Citizens Boulevard Simpsonville, Kentucky 40067
Re: K140984
Trade/Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FIN Dated: December 11, 2014 Received: December 12, 2014
Dear Ms. Holder:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Holder
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The name is written in black ink and appears to be a professional title. The letters are slightly italicized, giving the text a formal and elegant appearance. The "M.D." abbreviation indicates that the person is a medical doctor.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K140984
Device Name
TANGO3 Water Storage Tank with Ozone Disinfection System
Indications for Use (Describe)
The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for addition of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K140984 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Submitter's Name: | TANGO3, LLC
141 Citizens Blvd.
Simpsonville, KY 40067
Telephone: (502) 722-8794 |
|-------------------|------------------------------------------------------------------------------------------|
| Contact person: | Hugh Doss, Manager |
Date of Summary: January 9, 2015
Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System
Device Classification Name: Hemodialysis System and Accessories (876.5820, FIN)
Device Classification: Class II
Device Description: The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the distribution loop. The solution is recirculated throughout the distribution system. To complete the disinfection process, the system and distribution loop are then rinsed with adequate water. The described process is accomplished with 4 consecutive 30 minute cycles of ozone disinfection weekly. In addition, a disinfection cycle of 45 minutes multiple times per week may also be used for additional reduction of bioburden (as determined by user facility monitoring). After disinfection TANGO3 will leave the distribution loop with less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
System Description and Theory of Operation
The TANGO3 Water Storage Tank with Ozone Disinfection System consists of the following components: a heat regenerative desiccant air dryer at a 20 SCFH of air flow, a Corona discharge ozone generator that produces a working concentration of 0.3ppm of ozone, a venturi based injection system, HDPE or Stainless Steel water storage tank, an off gas ozone destruct system, a multi-stage centrifugal distribution pump (duel distribution pumps are offered as an option), and a main controller and operator's interface. Sensors incorporated into the system include return and output flow sensors, an ozone sensor, a level sensor, a conductivity sensor, and an atmospheric ozone detector. Fluid contacting materials include: Stainless Steel 300 Series, High Density Polyethylene (HDPE), Lexan® (Polycarbonate), Acrylic (PMMA), Teflon® (PTFE), Viton® (FKM), Kynar® (PVDF), and PVC. The System produces a dissolved ozone concentration of 0.20 ppm to 0.30 ppm during the disinfection process.
The TANGO3 System has been designed to meet the applicable requirements of the following voluntary standards:
4
- AAMI /ANSI RD52:2004 Dialysate for hemodialysis ■
- AAMI/ANSI RD62:2006 Water treatment equipment for hemodialysis applications ■
- AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and ■ related therapies
Ozone is produced in a flat gas stream which results in low energy consumption and high ozone concentration. Energy consumption is less than 7 kW per kilo ozone produced.
The ozone disinfection process is derived through the generator located on the front of the device. Atmospheric air passes through silica beads removing humidity from the air. The air then passes through an air dryer to additionally remove all remaining moisture from the air. The dry air passes between two electrode plates consisting of high current. To prevent the air from breaking down electrically along a simple line of rupture or spark, a sheet of glass is placed between the metal plates. By this means the air is made to break down electrically throughout thus greatly increasing the amount of ozone produced.
The air in the system is not pressurized but operates under a vacuum produced when the ozone recirculation pump is operating. The pump uses the purified water from the storage tank to pressurize the water. Then the water passes through a venturi creating a vacuum which will pull atmospheric air through the acrylic tube with silica gel, through the air dryers, and then through the generating chamber. The ozone gas is mixed with the purified water at the venturi and diffused into the holding tank. The ozonated water is then distributed from the holding tank to the distribution loop through the distribution pump and returns back to the storage tank. The return loop is monitored for dissolved ozone level achieving a level of 0.2 ppm to 0.3 ppm. Upon completion of the disinfection dwell time, a flushing phase is activated to destroy the residual ozone prior to use with patients.
To protect the distribution piping and well as other water contacting materials, a low level of ozone is used. Laboratory testing has proven a 6 log reduction of microbiological contamination when using dissolved ozone concentration levels between 0.2 ppm to 0.3 ppm while showing no immediate effect on PVC distribution piping.
Operation Overview
Three operational modes are provided: Dialysis, Maintenance, and Disinfection. The system is set to dialysis mode when the water system is being used for dialysis. The system is set to maintenance mode to allow for manual control of the system. Ozone product only occurs in disinfection mode. A description of the disinfection process follows.
The disinfection process is divided into the following phases, as shown above:
-
- Ozonation: During this phase the ozone generator is on and ozonated water is being recirculated through the loop.
-
- Loop and Tank Emptying: Once the ozonation phase is complete a valve will be actuated and the returning flow will go to drain instead of returning to the tank. The distribution pump will be kept on until the LOW TANK level is detected. At this point, the distribution pump, ozone generator and recirculation pump will be turned off. The tank drain valve will open. allowing the tank to empty by gravity.
5
-
- Tank and Loop Refill: After the loop and tank are empty, TANGO3 will allow adequate water to enter the storage tank. Once the TOP FLOAT level is detected, no more water will be allowed to enter the tank.
-
- During the weekly disinfection cycle, steps 1) through 3) will be repeated for each cycle.
-
- Ozone Destruction: A flushing process will be done with non ozonated water until the ozone sensor detects that the level of ozone residual complies with the AAMI requirements
To avoid the possibility of dissolved 03 in the distribution loop while water is being used for other purposes, the system has two (2) flow meters to measure the input and the output of the storage tank. If those two (2) readings are not equal the ozone generator and the distribution pump will be turned off. In addition, daily manual checks may be performed to assure the absence of ozone in the loop prior to the beginning of the dialysis treatment using a properly calibrated digital colorimeter.
The presence of ozone in the room will also be monitored using an ambient ozone sensor and/or ambient ozone detection badges. Visual and audible alarms will be given if the levels are above normal OSHA and EPA exposure values.
Intended Use: The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).
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Legally Marketed Devices to which Equivalence is Claimed:
- TANGO3 Water Storage Tank with Ozone Disinfection System K0903641 ■
Descriptive Summary of Technological Characteristics and Those of the Predicate Device: The features of TANGO3 are equivalent to the predicate device in terms intended use, technological characteristics, and operational characteristics as summarized in the following table:
| PREDICATE DEVICE: | ||
|---|---|---|
| TANGO3, LLC TANGO3 Water Storage | PROPOSED DEVICE: | |
| PARAMETER | Tank with Ozone Disinfection System | |
| K093641 | TANGO3, LLC TANGO3 Water Storage | |
| Tank with Ozone Disinfection System | ||
| Classification Name And | ||
| Product Code | Hemodialysis System and Accessories | |
| FIN | Hemodialysis System and Accessories | |
| FIN | ||
| Intended Use | The TANGO3 Water Storage Tank with | |
| Ozone Disinfection System is intended to be | ||
| used for disinfection of the water | ||
| distribution system of a dialysis facility. | The TANGO3 Water Storage Tank with | |
| Ozone Disinfection System is intended to be | ||
| used for disinfection of the water distribution | ||
| system of a dialysis facility. | ||
| Indications for Use | The TANGO3 Water Storage Tank with | |
| Ozone Disinfection System is intended to be | ||
| used for disinfection of the water | ||
| distribution system of a dialysis facility. The | ||
| tank of the TANGO3 is also used as the | ||
| water holding tank of the distribution | ||
| system. The disinfection process is | ||
| completely automated. Ozone concentration | ||
| during disinfection is between 0.2 ppm and | ||
| 0.3 ppm. The distribution system will be | ||
| exposed to ozone for one (1) period of 45 | ||
| minutes and three (3) periods of 30 minutes | ||
| with adequate water flushes between them | ||
| and at the end, leaving the distribution loop | ||
| without ozone. | The TANGO3 Water Storage Tank with | |
| Ozone Disinfection System is intended to be | ||
| used for disinfection of the water distribution | ||
| system of a dialysis facility. The tank of the | ||
| TANGO3 is also used as the water holding | ||
| tank of the distribution system. The | ||
| disinfection process is completely | ||
| automated. Ozone concentration during | ||
| disinfection is between 0.2 ppm and 0.3 | ||
| ppm. Weekly disinfection cycles should be | ||
| for four periods of 30 minutes with adequate | ||
| water flushes between them and after the last | ||
| cycle. In addition to the weekly disinfection | ||
| cycle, a 45 minute disinfection cycle with at | ||
| least two rinse cycles may also be performed | ||
| multiple times weekly for additional | ||
| reduction of bioburden as determined by | ||
| user facility monitoring. At the end of | ||
| disinfection, the distribution loop will have | ||
| less than 0.1 mg/l. (0.1 ppm) of ozone, in | ||
| accordance with AAMI/ISO 26722:2009 | ||
| (4.2.13.5). | ||
| Materials in Contact With | ||
| Fluids | Stainless Steel, Teflon, PVC | Stainless Steel, Teflon, PVC, HDPE |
| Water Requirements: | ||
| Water Quality | AAMI Quality | AAMI Quality |
| Environmental Limits: | ||
| Ambient Temperature | 40° - 100° F (4.4° - 38° C) | 40° - 100° F (4.4° - 38° C) |
| Relative Humidity | 10 - 80% | 10 - 80% |
| Ambient Ozone |