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.
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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.
Treatment time:
1 hour
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.
Treatment time:
1 hour
INDICATIONS FOR USE:
- Chronic edema
- Lymphedema
- Venous insufficiency
- Wound healing
CONTRAINDICATIONS:
- 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).