Regulatory
The EPITECH™ Model 1002 is a Class I medical device and is registered with the FDA under listing number D437168 (510(k) exempt). TARA Medical Devices LLC is licensed by the State of Texas as a medical device manufacturer.
Specifications
Vacuum adjustable to -500mmHg (-20inHg)
Default is -330mmHg (-13inHg)
for optimum results
Temperature adjustable from 35°C (95°F) to 45°C (113°F)
Temperature default value is 42°C (108°F) for optimum results in most cases
Heat can be turned off for suction-only use
Maximum temperature cutoff helps avoid side effects from excessive heat
Supply voltage options for multiple countries
110-120VAC 60Hz (North America)
220-240VAC 50/60Hz (Europe, Asia, Africa)
Harvested area from 0.7cm2 to 9.4cm2 using standard chambers
Custom orifice plates can be designed to address specific applications
Safety
Tested to IEC 60601-1 medical device safety standard
Heater failsafe features
No high voltage electricity (>5 volts) is within one meter of patient
Fully grounded aluminum console case
Fused power input (user replaceable)
Hospital-grade power cord
Privacy
No patient data may be entered or is stored in the device
Only device firmware is stored in non-volatile memory
No data interfaces
No interfaces for removable media
Questions?
For more information about the EPITECH™ 1002 technical, safety, regulatory certification, or any additional information about the device, contact us Here, or call (214) 377-8144 to speak to a representative.
Do you have questions about the features or implementation of the EPITECH™ 1002?
Send us a detailed request and our support team will contact you. Please indicate your preferred method of contact. We look forward to answering your questions.