Entre™ System User Guide and Additional Information
for LOWER BODY
The Entre system is designed for at-home treatment of lymphedema, chronic edema and chronic wounds. This guide provides the information needed to set up and use your Entre system.
ENTRE SYSTEM TREATMENT OPTIONS FOR LOWER BODY
FULL LEG TREATMENT
This option provides full leg treatment in a distal to proximal (foot to top of thigh) direction via the sequential inflation of the eight chambers.
HALF LEG TREATMENT
This option provides below-the-knee treatment in a distal to proximal (foot to top of knee) direction via the sequential inflation of the eight chambers.
INDICATIONS FOR USE:
- Chronic edema
- Venous insufficiency
- Wound healing
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease)
- Active cancer (cancer that is currently under treatment, but not yet in remission)
- Any circumstance where increased lymphatic or venous return is undesirable
TRAVELING WITH YOUR ENTRE SYSTEM:
Patients may travel with any device that is medically necessary and can go through the x-ray screening process. Tactile Medical recommends patients traveling with their device do the following:
- Carry on their controller and power cord; patients may pack any garments/sleeves in their checked luggage
- Bring their user guide and prescription card with them to better help explain what the device does to a TSA agent
- Take the controller out of the carry on, as is done with a laptop
- Be prepared to turn the device on and show a TSA agent how the device works, if asked to do so
ADDITIONAL HELPFUL INFORMATION:
- The device will operate from 100 – 240 volts, 50/60 Hz, working nearly anywhere in the world without the need for a transformer or voltage converter. If traveling outside the US, a plug adapter may be necessary, and can be purchased at a retail store. Tactile Medical does not supply plug adapters.
- Websites such as www.tsa.gov, or the equivalent agency in your destination country may be able to give your more information.
- The following FDA website link show our products have been cleared to market in the US: https://www.accessdata.fda.gov/cdrh_docs/pdf14/K143185.pdf
- If you have any additional questions, please contact Tactile Medical at 1.833.3TACTILE (1-833-382-2845).