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.

 

How to order