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 Features
Several events will shut down the heater
Chamber temperature reaches 55° (to protect against hardware malfunction)
Absence of controller “heartbeat” signal (to protect against software malfunction)
Loss of signal from thermal feedback sensor
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
Patient 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.