Flexitouch® Plus User Guide for Lower Body

FLEXITOUCH PLUS PROGRAM OPTIONS FOR LOWER BODY

Full Leg and Core: Program L1

This program provides distal to proximal treatment preceded by proximal clearing of lymphatic fluid in the trunk, thigh, calf and foot. Enhanced programming applies treatment that extends past the inguinal area into the trunk, providing comprehensive treatment to patients when clinically appropriate.

Treatment time:

1 hour

How it works:

• Trunk: directs fluid from the groin toward the waist; cycle repeats
• Thigh: directs fluid from the knee toward the top of the thighs; cycle repeats
• Calf: directs fluid from the ankle toward the knee; cycle repeats
• Foot: directs fluid from the foot toward the ankle; cycle repeats
• Full leg and trunk: directs fluid from the toes to the waist in one continuous motion; cycle repeats

FULL LEG TREATMENT: PROGRAM L4

This program provides distal to proximal treatment preceded by proximal clearing of lymphatic fluid in the thigh, calf and foot.

Treatment time:

1 hour

How it works:

• Thigh: directs fluid from the knee toward the top of the thigh; cycle repeats
• Calf: directs fluid from the ankle toward the knee; cycle repeats
• Foot: directs fluid from the foot toward the ankle; cycle repeats
• Full leg: directs fluid from the toes to the top of the thigh in one continuous motion; cycle repeats

HALF LEG PLUS TREATMENT: PROGRAM L5

This program provides distal to proximal treatment preceded by proximal clearing of lymphatic fluid in the calf and foot.

Treatment time:

30 minutes

How it works:

• Calf: directs fluid from the ankle toward the knee; cycle repeats
• Foot: directs fluid from the foot toward the ankle; cycle repeats
• Half leg: directs fluid from the foot toward the knee; cycle repeats

The Flexitouch Plus 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:

• Lymphedema
• Primary Lymphedema
• Post mastectomy edema
• Phlebolymphedema
• Lipedema
• 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 Plus system should not be used if you have one or more of the following conditions:

• 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)
• Any circumstance where increased lymphatic or venous return is undesirable
• During pregnancy (applies only to the Flexitouch Plus trunk accessory)

Some health plans may not approve payment for the Flexitouch Plus 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

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.

• 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/pdf17/K170216.pdf
• If you have any additional questions, please contact Tactile Medical at 1.833.3TACTILE (1-833-382-2845)