The Flexitouch 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 Flexitouch System.
Indications for Use:
The Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:
- Primary lymphedema
- Post-mastectomy edema
- Edema following trauma and sports injuries
- Post-immobilization edema
- Venous insufficiency
- Reducing wound healing time
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
The Flexitouch System should not be used if you have one or more of the following contraindications:
- Pulmonary edema
- Congestive heart failure
- Deep vein thrombosis
- Episodes of pulmonary embolism
- Infections and inflammations
- Conditions in which increased lymphatic return is undesirable
- Acute cancer
The Flexitouch System trunk accessory should not be used during pregnancy
The head garment and vest for head and neck for the Flexitouch System should not be used if you have one or more of the following conditions:
- Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression)
- Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6–8 week post-operative
- Increased intracranial pressure or other contraindication
to internal or external jugular venous compression
- Any condition in which increased venous and lymphatic return is undesirable
- Carotid sinus hypersensitivity syndrome
- Acute facial infection (e.g., facial or parotid gland abscess)
- Internal jugular venous thrombosis (within 3 months)
- Facial or head and neck dermal metastasis
- Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
- Symptomatic bradycardia in the absence of a pacemaker
Clinical Documentation Guidelines for Flexitouch Therapy
Some health plans may not approve payment for the Flexitouch System until the patient has first tried a basic compression pump and found it to be ineffective. The patient’s medical records may require documentation that the patient:
- Has tried at least four weeks of conservative home therapy, including the use of compression bandaging or garment, exercise, and elevation
- Continues to manifest significant symptoms, such as continued swelling, fibrosis, impaired skin integrity, pain, impaired mobility and recurrent cellulitis
Traveling with Your Flexitouch 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.
- Websites such as www.tsa.gov, or the equivalent agency in your destination country may be able to give your more information.
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 U.S., a plug adapter may be necessary and can be purchased at a retail store. Tactile Medical does not supply plug adapters.
- The following FDA website links show our products have been cleared to market in the U.S.: https://www.accessdata.fda.gov/cdrh_docs/pdf6/K062818.pdf
- If you have any additional questions, please contact Tactile Medical at 866.435.3948