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Tactile Medical Flexitouch PD32-U User Manual

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User Guide
Model PD 32 -U (U.S.)

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Summary of Contents for Tactile Medical Flexitouch PD32-U

  • Page 1 User Guide Model PD 32 -U (U.S.)

  • Page 2: Table Of Contents

    The Flexitouch system is designed for at-home treatment of lymphedema, chronic Tactile Medical ....1 5.1 Applying the Arm Garment ..24 edema and chronic wounds.

  • Page 3: Indications For Use

    • Never operate the controller if the cord or plug is not working properly, if it has been damaged, or if the controller has been dropped into water. Return it to Tactile Medical for inspection or repair. Do not modify the cord or plug.

  • Page 4: Contraindications

    1 .4 Contraindications 1 .5 Unpacking Instructions The Flexitouch system should not be used if you have one or more of the When your Flexitouch system arrives, allow the controller to reach room following conditions: temperature for one hour before using. It is important that you carefully unpack the contents and ensure that you have all the equipment required to •...

  • Page 5: The Flexitouch® System

    C HAPT E R 2 Upper Extremity Treatment The Flexitouch System The garments and accessories needed for upper extremity treatment may include ® the following: • Arm/arm-shoulder garment The Flexitouch system is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess •...

  • Page 6: Programmed Pressure Levels

    Please consult with your healthcare provider before changing those settings. For technical assistance on how to manually adjust the gradient pressures delivered to various treatment areas of the body, please call Tactile Medical at 1.866.435.3948. Customer Service Toll-Free: 833.382.2845 (833.3TACTILE)
  • Page 7 Figure 2b: Full Leg and Core Figure 2c: Full Leg Plus Treatment Program L1 Treatment Program L This treatment option provides the ability to deliver therapy to both the leg and trunk regions This treatment option provides the ability to deliver expanded therapy to the leg when clinically appropriate.

  • Page 8: Treating The Upper Extremity

    2 .4 Treating the Upper Extremity Figure 2d: Full Arm Figure 2e: Full Arm and Core Treatment Program U Treatment Program U Providing traditional arm treatment, this option moves excess This treatment option provides the ability to deliver therapy to the arm, chest and trunk regions lymphatic fluid in a distal to proximal (hand to top of bicep) direction when clinically appropriate.

  • Page 9: Treating The Head And Neck

    2 .5 Treating the Head and Neck C HAPT E R 3 Controller Set-Up Figure 2f: Head and Neck Treatment Program H1 This treatment option provides the ability to deliver therapy to the head and neck The Flexitouch system uses a controller and a set of garments and accessories to and chest when clinically appropriate.

  • Page 10: Select Your Settings

    3 .2 Select Your Settings Figure 3c . Controller Unit Front Panel Follow the steps outlined below to select the settings prescribed by your Program Time healthcare provider: Remaining Garment NOTE: The controller unit will store the settings used for the last therapy session Pressure and will automatically recall these settings.

  • Page 11: Garment And Accessory Application-Lower Extremity

    CHAPTER 4 Full Leg Garment Application: Garment and Accessory Application— 2. Sit down and place your leg on the garment. Center your heel between the second set of fabric notches (when counting from the toe of the garment). Lower Extremity 3.

  • Page 12: Applying The Full Leg Garment And Trunk Accessory

    4 .2 Applying the Full Leg Garment and Trunk Accessory Continue up your leg, wrapping the calf next and the thigh last. When wrapping, try to minimize any bunches or folds in the fabric and adjust the If you have received garments and accessories labeled full leg and trunk, follow hook fastener tabs as necessary to get a well-contoured fit.

  • Page 13: Applying The Calf-Foot Garment And Trunk-Thigh Accessory

    4 .3 Applying the Calf-Foot Garment and Trunk-Thigh 8. Place a couple of pillows under your calf and foot to elevate them just above Accessory your hips for optimal treatment. Place the hoses alongside your body so they are easy to reach when you are ready to attach them to the controller unit. If you have received garments and accessories labeled calf-foot and trunk-thigh, follow the preparation and application instructions below.

  • Page 14: Garment And Accessory Application-Upper Extremity

    CHAPTER 5 2. Next fold the four hook fastener tabs on the top of the arm garment back so they are secured to the arm garment itself. Garment and Accessory Application— Upper Extremity Arm Garment Application: 3. Slide your arm into the pre-shaped cone, making sure the tabs run along the Before starting, be sure you are using the recommended garment(s) and side of the garment closest to your torso.
  • Page 15 Trunk Accessory Preparation: Arm-Shoulder Preparation: NOTE: If you are treating both arms, you will only receive one trunk accessory, 6. In preparation for donning the arm-shoulder garment, loosely form the arm which is designed to treat either side of the body. You will have to follow these portion of the garment into a cone shape and fasten the hook tabs.
  • Page 16 11. Place your free hand (extremity not being treated) in the pocket located at Fully Applied Arm-Shoulder Garment the end of the chest strap, wrap it around the front of your chest, and snugly 13. Properly applied, the garment and accessories will follow the contours of your secure it to the chest flap to obtain a well-contoured fit.

  • Page 17: Garment Application

    CHAPTER 6 Head Garment Preparation and Application: Garment Application— 1. Place the head garment around the back of the head aligning the top of the garment so the forehead strap runs across the crown of the head. Head and Neck 2.
  • Page 18 Vest for Head and Neck Preparation and Application: 12. Pull the vest collar tabs straight down and attach the hook fastener pads to the chest of the vest garment. The collar tabs should not cross over the 6. Attach the back straps to the back flap of the vest garment so it is shaped like a vest. zipper, and are designed to help the neck chamber of the garment maintain 7.
  • Page 19 CHAPTER 7 5. Push the latch forward, it will hook on the top and bottom of the controller connector. You should hear a click when each of the latches is properly Connecting the Hoses to the Controller connected. Two clicks will be heard, one for the top and one for the bottom latch.

  • Page 20: The Controller

    CHAPTER 8 6. Repeat for all connectors required for your prescribed treatment. (Figure 7e, 7f and 7g.) Conducting a Therapy Session Figure 7e . Fully Attached Hose Connectors When Full Leg Treatment is Prescribed Now you are ready for your therapy session with the Flexitouch system. Be sure that you have followed the instructions outlined in the previous chapters.

  • Page 21: Completing The Therapy Session

    8 .3 Completing the Therapy Session Cleaning the Garments and Accessories 1. A lint brush or roller may be used to remove particles. The therapy program will stop automatically when the treatment has been completed and TIME REMAINING will display DONE. 2.

  • Page 22: Specifications

    2. Contact Tactile Medical for closure straps. Closure straps will assist in 5. Check to make sure the correct garment connectors are connected to the holding the fabric closed by allowing you to attach to an unworn part of correct port in the controller (e.g., the #4 garment connector is connected...

  • Page 23: Limited Warranty And Service For Home Use

    The Flexitouch system is protected by the following United States patents:* to be free from defects in material and workmanship for one (1) year from the date of purchase. Tactile Medical’s sole obligation in the event of a breach of this 6,179,796...
  • Page 24 Table 5: Flexitouch System – Classification Information Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity US FDA Medical Device Class II per 21CFR 870.5800 & 21 CFR 890.5650 The PD32-U Flexitouch system is intended for use in the electromagnetic environment specified below.
  • Page 25 Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued) The PD32-U Flexitouch system is intended for use in the electromagnetic environment specified below. The customer or the user of the Flexitouch should assure that it is used in such an environment. Immunity IEC 60601 Compliance...

  • Page 26: For Additional Questions

    For Additional Questions If you have any questions that are not covered by this user guide, contact: Tactile Medical 3701 Wayzata Blvd., Suite 300 Minneapolis, MN 55416 USA Telephone: 612.355.5100 Toll-free Telephone: 833.382.2845 (833.3TACTILE) (U.S. only) Fax: 612.355.5101 Toll-free Fax: 866.435.3949 (U.S. only) Hours of Operation: 7 a.m.
  • Page 27 No part of the contents of this guide may be reproduced or transmitted in any way, form, or by any means without the written permission of Tactile Medical. Tactile Medical Customer Service 3701 Wayzata Blvd., Suite 300 Toll-Free Tel: 833.382.2845 (833.3TACTILE) Minneapolis, MN 55416 USA Toll-Free Fax: 866.435.3949...

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