Tactile Medical Flexitouch Plus User Manual

Tactile Medical Flexitouch Plus User Manual

Advanced pneumatic compression system
Table of Contents

Advertisement

Quick Links

Flexitouch
Plus User Guide
®
Model PD32-G3

Advertisement

Table of Contents
loading

Summary of Contents for Tactile Medical Flexitouch Plus

  • Page 1 Flexitouch Plus User Guide ® Model PD32-G3...
  • Page 2: Table Of Contents

    Vest Garment ..........59 How to Contact Tactile Medical ....... 1 Applying Your Flexitouch Plus with ComfortEase Vest Safety Precautions and Explanation of Symbols .
  • Page 3: Determine Which Garment Style You Have And Follow Directions For

    How to Contact Tactile Medical only in accordance with EN60601-1 IP21 If you have questions about the Flexitouch Plus system or require Flexitouch Plus system complies with IEC60329 regarding degree of protection service, contact Tactile Medical: against water and particulates.
  • Page 4: Indications For Use

    Plus system. ƒ Do not reach for the controller unit if it falls into water. Unplug the controller unit ƒ Never use hot devices, such as irons or blow dryers, on or near the Flexitouch Plus at the electrical outlet immediately.
  • Page 5: Contraindications

    ƒ Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6–8 week post-operative The Flexitouch Plus system should not be used if you have one ƒ Facial or head and neck dermal metastasis or more of the following conditions: ƒ...
  • Page 6: Kylee - Personal Lymphedema Assistant Mobile Application

    Figure 1.5.a. for Flexitouch Plus with ComfortEase garments. ƒ ComfortEase Full Leg garment (x-short, short, medium or long) The label indicates the type of garment you have – Flexitouch Plus ƒ ComfortEase Trunk garment (small, medium, large or x-large) with ComfortEase, or Flexitouch Plus – and the body area where ƒ...
  • Page 7 Paired Bluetooth power is on and the Flexitouch Plus device is successfully paired with Kylee On the main screen of your Flexitouch Plus device, navigate to the Connected The Flexitouch Plus device is actively sending data to Kylee; Device Status option and select Enter. Within Device Status, navigate this happens periodically and takes about 10 seconds to View Bluetooth Menu and select Enter to view options.
  • Page 8: Chapter 2 The Flexitouch Plus System

    (or leg garments), or both a leg garment (or leg garments) and a trunk garment. The Flexitouch Plus system is an advanced pneumatic compression The upper extremity garment(s) and accessories are used to treat the device clinically proven to stimulate the lymphatic system. The device arm(s), chest and core.
  • Page 9 FLEXITOUCH PLUS with ComfortEase Table 1: Treatment Programs and Treatment Times for Flexitouch Plus Garments Table 2: Treatment Programs and Treatment Times for Flexitouch Plus with ComfortEase Garments Treatment Available Treatment Available Program Program Display Body Regions Treated Program Program Display Body Regions Treated Time (min.)
  • Page 10: Treating The Lower Extremity

    Treating the Lower Extremity Primary Treatment Program L9/CL9: Petite Leg and Core Primary Treatment Program L1/CL1: Full Leg and Core This option delivers treatment to both the leg and trunk regions when clinically appropriate. It provides incremental proximal This option delivers treatment to both the leg and trunk regions clearing of lymphatic fluid in the trunk, thigh, calf and...
  • Page 11 Primary Treatment Program L4/CL4: Full Leg Plus Supplemental Treatment Program L2/CL2: Trunk Only (Upward) This option delivers treatment to the leg when clinically appropriate. This option delivers treatment to the trunk region when clinically It provides incremental proximal clearing of lymphatic fluid in the appropriate.
  • Page 12: Treating The Upper Extremity

    Treating the Upper Extremity Primary Treatment Program U4/CU4: Arm-Shoulder This option delivers treatment to the arm and chest regions when Primary Treatment Program U1/CU1: Full Arm and Core clinically appropriate. It provides incremental proximal clearing of This option delivers treatment to the arm, chest and trunk regions lymphatic fluid in the chest, biceps,...
  • Page 13 Supplemental Treatment Program U2/CU2: Trunk Only (Downward) Supplemental Treatment Program U3/CU3: Trunk and Chest This option delivers treatment to the trunk region when clinically This option delivers treatment to the trunk and chest regions when appropriate. It provides incremental proximal clearing of lymphatic clinically appropriate.
  • Page 14: Treating The Head And Neck

    Supplemental Treatment Program CU8: Chest (Inward) Treating the Head and Neck This treatment option provides the ability to deliver treatment to Primary Treatment Program H1/CH1: Head, Neck and Chest the chest region when clinically appropriate. Incremental proximal This treatment option provides the ability to deliver treatment to clearing of lymphatic fluid in the chest and shoulder regions the head, neck and chest when clinically appropriate.
  • Page 15: Chapter 3 Controller Unit Setup

    It provides incremental proximal clearing of lymphatic fluid in the chest region (Figure 2.5.b.). The Flexitouch Plus system consists of a controller unit, a garment set and accessories to treat your condition. In this chapter, you Treatment time: 12 minutes.
  • Page 16: Selecting Your Settings

    2800_Control_Panel_KL.pdf 12/9/16 1:50 PM On/Off Back A plug adapter may be necessary for use Down outside the U.S. Enter Connector Figure 3.1.a. Power Adapter Number Selecting Your Settings Follow the steps outlined below to select the settings prescribed by your healthcare provider. Figure 3.2.a.
  • Page 17: Chapter 4 Connecting Your Hoses To The Controller Unit

    3. On the home screen, press the arrow button until the ————————————— C H A P T E R 4 ————————————— CHOOSE A NEW TREATMENT option is highlighted in blue. Once Connecting Your Hoses to the highlighted, select the button. Using the arrow buttons, and by pressing the button when the appropriate...
  • Page 18: Connecting Your Flexitouch Plus Lock/Unlock Style Connectors To The Controller Unit

    FLEXITOUCH PLUS with ComfortEase Connecting Your Flexitouch Plus Lock/Unlock Style Connectors to the Controller Unit Ensure paddles are perpendicular to the adapter before attaching the bilateral port The Flexitouch Plus with ComfortEase has adapter to the controller unit lock/unlock icons on the connectors (Figure 4.2.a.).
  • Page 19 FLEXITOUCH PLUS with ComfortEase 2. Line up the numbered latch with the port on the corresponding 4. Repeat these steps for all connectors required for your controller unit (Figure 4.2.d.). prescribed treatment (Figures 4.2.f., 4.2.g., 4.2.h., 4.2.i. and 4.2.j.). 3. Push the numbered latch forward onto the controller unit until you hear a “click.”...
  • Page 20: Connecting Your Flexitouch Plus Hoses To The Controller Unit - Ridged Style

    FLEXITOUCH PLUS with ComfortEase Connecting Your Flexitouch Plus Hoses to the Controller Unit – Ridged Style The Flexitouch Plus has ridges on the connectors (Figure 4.3.a.). Port Cover Figure 4.2.j. Fully Attached Hose Connectors when Bilateral Port Figure 4.3.a. Flexitouch Plus...
  • Page 21 4. Reposition your hand so your thumb and fingers are positioned on the top and bottom latch ridges. This enables you to slide the latch (#4 in Figure 4.3.d.). Do not remove Reposition your hand port cap(s) so it is now pushing forward with the collar against the ridges on Figure 4.3.f.
  • Page 22: Chapter 5 Trunk Garment Application

    ƒ Restrictive clothing, such as: elastic-banded underwear, compression bandaging, elastic-banded socks, compression garments or bra CAUTION ƒ The Flexitouch Plus garments should not be placed in direct contact with an open wound. It is recommended that wounds be properly dressed before the Figure 5.1.b.
  • Page 23 FLEXITOUCH PLUS with ComfortEase Applying Your Trunk Garment for Daily Treatment 2. Open the pocket closure labeled 1. Sit down and slide your trunk garment on as you would a pair of shorts. 7. Sit down and open the zipper on your trunk garment. Slide your trunk garment on as you would a pair of shorts.
  • Page 24: Applying Your Flexitouch Plus Trunk Garment

    Applying Your Flexitouch Plus Trunk Garment Applying Your Trunk Garment for Daily Treatment 2. Sit down and open the pocket closure to slide your garment on These instructions apply to the trunk garment pictured in Figures as you would a pair of shorts. Bring the inside flap of your trunk 5.2.a.
  • Page 25: Chapter 6 Lower Extremity Garment Application

    4. To reshape CAUTION your full leg garment like a boot, apply tabs ƒ The Flexitouch Plus garments should not be placed in direct contact with an Figure 6.1.c. 1 through 4. Ensure the zipper is open and slide open wound.
  • Page 26 FLEXITOUCH PLUS with ComfortEase 3. Next, center your heel in the heel cup area where the foot section bends. Align the hoses along the back of your leg. Zip up your full leg garment (Figure 6.1.d.). 4. Adjust the numbered tabs 1 through 7 as necessary to get the desired fit, while being careful to minimize bunches and folding as best you can.
  • Page 27: Applying Your Flexitouch Plus Full Leg Garment

    FLEXITOUCH PLUS with ComfortEase Applying Your Flexitouch Plus Full Leg Garment 1. Apply your full leg garment by laying it out on a bed, couch or recliner so the foot section is at the bottom and the tubing cover These instructions apply to the full leg garments pictured in runs along the back of your leg (Figure 6.1.h.).
  • Page 28 5. Continue to contour your garment using the hook fasteners for a secure fit up the calf and thigh (#5 in Figure 6.2.b.). When wrapping, try to minimize any bunches or folds in the fabric and adjust the hook fastener tabs as necessary to get a well-contoured fit.
  • Page 29: Applying Your Flexitouch Plus Half Leg Garment

    Applying Your Flexitouch Plus Half Leg Garment 6. Finally, place a couple of pillows under your calf and foot to elevate them just above your hips for optimal treatment (#6 in Preparing Your Half-Leg Garment for the First Time Figure 6.3.b.). Place the hoses alongside your body so they will 1.
  • Page 30: Applying Your Flexitouch Plus Ext Half Leg Garment And Trunk-Thigh Garment

    Applying Your Flexitouch Plus EXT Half Leg Garment and Trunk-Thigh Garment EXT Half Leg Garment and Trunk-Thigh Garment Preparation Ensure the two 1. Unfold and place your trunk-thigh garment on the bed or sofa. garments overlap Position it so when you sit on it, the seam will be along the outside of your leg.
  • Page 31: Chapter 7 Upper Extremity Garment Application

    CAUTION ƒ The Flexitouch Plus garments should not be placed in direct contact with an open wound. It is recommended that wounds be properly dressed before the garment is applied. Contact your healthcare provider if you have any questions.
  • Page 32: Applying Your Flexitouch Plus With Comfortease

    FLEXITOUCH PLUS with ComfortEase Applying Your Flexitouch Plus with ComfortEase Preparing Your Vest Garment for the First Time Vest Garment 1. Unfold and place your vest garment on a bed or sofa so the zipper and adjustment tabs labeled ‘1’ through ‘4’ are facing These instructions apply to the vest garment pictured in Figure 7.1.a.
  • Page 33 FLEXITOUCH PLUS with ComfortEase 2. Slide your vest garment on as you would a jacket, and use the 5. Locate the adjustment tabs labeled ‘2’ under each armpit and zipper lanyard to zip your vest garment closed (Figure 7.1.c.). Put place your thumbs through the end of the tabs.
  • Page 34 FLEXITOUCH PLUS with ComfortEase 6. Locate the adjustment tabs labeled ‘4’ on each arm. Detach 7. If necessary, once all adjustment tabs have been applied, locate each adjustment tab one at a time, and smooth the inner flap the black handle loops at the front, bottom of your vest garment downward and around the underside of your biceps.
  • Page 35: Applying Your Flexitouch Plus With Comfortease Vest

    FLEXITOUCH PLUS with ComfortEase Applying Your Vest Garment for Daily Treatment Applying Your Flexitouch Plus with ComfortEase Vest and Arm Garment 8. Slide your vest garment on as you would a jacket. Zip closed your vest garment using the front zipper lanyard. Put your thumbs...
  • Page 36 FLEXITOUCH PLUS with ComfortEase Preparing Your Vest and Arm Garment for the First Time 2. Your arm garment should arrive in a formed loose “cylinder.” Ensure all adjustment tabs are folded onto themselves to prevent 1. If you are not currently wearing your vest garment, locate it and accidental sticking as you prepare your arm garment.
  • Page 37 FLEXITOUCH PLUS with ComfortEase NOTE: Ensure your arm garment overlaps the biceps portion of your vest 3. Using your non-treatment arm, grab the inner fabric and D-ring together. Slide your arm that will be receiving treatment, into the garment to minimize gapping. If overlapped correctly, there should be garment, so the garment overlaps the biceps portion of your vest no gap between your vest garment and your arm garment.
  • Page 38 FLEXITOUCH PLUS with ComfortEase 6. Locate the adjustment tabs ‘B’ and ‘C.’ Unfold and attach them 7. To finalize the fitting of your arm garment, unhook the to the vest garment (Figure 7.2.k.). adjustment tab labeled ‘5’ and pull inward toward your body until you feel a snug –...
  • Page 39 FLEXITOUCH PLUS with ComfortEase NOTE: Your arm garment should not feel as tight as a compression Alternative Option for Preparing Your Vest and Arm Garment garment. for the First Time 1. Unfold and place your arm garment on a bed or sofa with the NOTE: If your fingers stick out the end of your arm garment, you can zipper closed.
  • Page 40 FLEXITOUCH PLUS with ComfortEase 7. Zip your arm garment closed (Figure 7.2.q.). 5. Unzip your forearm zipper, so your hand can remain free once you put on your combined vest and arm garment. 8. Locate the tab labeled ‘E’ at your armpit, and unfold and attach 6.
  • Page 41 NOTE: The hand loop is optional and can be requested by contacting Tactile Medical using one of the following options. ƒ Email: info@tactilemedical.com. ƒ Phone: Customer Service, toll free at 833.3TACTILE (833.382.2845), 7 a.m.
  • Page 42 FLEXITOUCH PLUS with ComfortEase Applying Your Vest Garment and Arm Garment for Daily NOTE: If your vest garment is too tight, you may need to readjust the Treatment black cinch straps slightly at your abdomen, or use the tabs labeled ‘1’...
  • Page 43 FLEXITOUCH PLUS with ComfortEase NOTE: You should remove your vest and arm garment first, followed by Removing Your Vest and Arm Garment your trunk garment (if you are prescribed the use of a trunk garment). 9. To remove your vest and arm garment at the end of your single-arm treatment session, unzip your forearm zipper.
  • Page 44: Applying Your Flexitouch Plus Arm-Shoulder Garment

    Applying Your Flexitouch Plus Arm-Shoulder 8. Properly applied, your garment and accessories will follow Garment the contours of your body and fit snugly, yet comfortably (Figure 7.3.d.). Make any necessary adjustments after you lie Preparing Your Arm-Shoulder Garment for the First Time down to ensure a well-contoured fit.
  • Page 45 Applying Your Arm-Shoulder Garment for Daily Use 10. Place your free hand in the pocket located at the end of the chest strap. Wrap it around the front of your body and secure it to the NOTE: If your treatment requires trunk garment, see Chapter 5, outer chest flap (Figure 7.3.f.).
  • Page 46 Removing Your Arm-Shoulder Garment 11. Use a pillow to elevate your arm slightly above your torso during treatment (#11 in Figures 7.3.g. and 7.3.h.), and angle your arm 12. To remove your garments at the end of the treatment session, about 45 degrees out from the side of your body.
  • Page 47: Chapter 8 Head And Neck Garment Application

    ————————————— CAUTION Head and Neck Garment ƒ The Flexitouch Plus garments should not be placed in direct contact with an open wound. It is recommended that wounds be properly dressed before the Application garment is applied. Contact your healthcare provider if you have any questions.
  • Page 48 FLEXITOUCH PLUS with ComfortEase Preparing Your Vest Garment for the First Time 2. Slide your vest garment on as you would a jacket, and use the zipper lanyard to zip your vest garment closed (Figure 8.1.c.). Put 1. Unfold and place your vest garment on a bed or sofa, so the your thumbs through the black handle loops at the front bottom zipper and the adjustment tabs labeled ‘1’...
  • Page 49 FLEXITOUCH PLUS with ComfortEase 5. Locate the adjustment tabs labeled ‘2’ under each armpit and 6. Locate the adjustment tabs labeled ‘4’ on each arm. Detach place your thumbs through the end of the tabs. Pull the tabs each adjustment tab, one at a time, and smooth the inner flap forward and slightly upward, one at a time, to achieve a snug fit downward and around the underside of your biceps.
  • Page 50 FLEXITOUCH PLUS with ComfortEase Applying Your Vest Garment for Daily Treatment 7. If necessary, once all adjustment tabs have been applied, locate the black handle loops at the front bottom of your vest garment, 8. Slide your vest garment on as you would a jacket. Zip your vest and push in a downward motion to adjust the position of your garment closed using the front zipper lanyard.
  • Page 51: Applying Your Flexitouch Plus With Comfortease

    FLEXITOUCH PLUS with ComfortEase Applying Your Flexitouch Plus with ComfortEase NOTE: A mirror may be helpful for garment placement and fitting when Head Garment applying the head garment. 2. Place your head garment around the back of your head, aligning...
  • Page 52 FLEXITOUCH PLUS with ComfortEase Applying Your Head and Neck and Vest Garments for Daily Treatment 1. If you are not currently wearing your vest garment, locate it and slide it on as you would a jacket. Identify both ends of the front zipper, and zip your vest garment closed using the front zipper pull.
  • Page 53 FLEXITOUCH PLUS with ComfortEase 2. Place your head and neck garment around your head, aligning the forehead strap so it runs across the middle of your forehead and fits snugly, but not too tight (Figure 8.2.h.). 3. Adjust the right inner chin strap, so it fits snugly under the chin (Figure 8.2.i.).
  • Page 54 FLEXITOUCH PLUS with ComfortEase Removing Your Head and Neck and Vest Garments 4. Slide your head and neck garment off the top of your head, leaving the forehead strap fastened for your next use 1. To remove your head and neck and vest garments, turn the (Figure 8.2.o.).
  • Page 55: Applying Your Flexitouch Plus Vest Garment

    Applying Your Flexitouch Plus Vest Garment Preparing Your Vest Garment for the First Time Figure 8.3.b. 1. Unfold your vest garment so the zipper is facing up. This is the front of the vest garment. The collar tabs are located near the neck of the garment.
  • Page 56: Applying Your Flexitouch Plus Head Garment

    Applying Your Flexitouch Plus Head Garment Preparing Your Head Garment for the First Time 1. Unfold your head garment, so the head strap is facing up and located at the top. This is the front of the head garment. The nose piece is located with the garment.
  • Page 57 Applying Your Head and Neck Garment for Daily Use 7. Locate your head and neck garment, and slide the garment on so the plastic D-ring is positioned across the front of your forehead. Next, contour the nose piece across the bridge of the nose, and secure the hook fasteners to the side of the head garment.
  • Page 58 Removing Your Arm-Shoulder Garment 9. Locate your vest garment and slide it on as you would a jacket. Align both sides of the front zipper at the bottom of the vest 10. To remove your garments at the end of the treatment session, garment, and zip up the front of the garment to the collar opening remove the vest garment first and then the head garment (Figure 8.4.
  • Page 59: Chapter 9 Conducting Your Treatment Session

    45 degrees. Storing Your Flexitouch Plus System 3. Check your program settings to ensure you have selected the Store your Flexitouch Plus system using the following steps: correct program. 1. Unplug the power adapter from the controller unit and from 4.
  • Page 60 Keep them out of excessive heat or cold. Store them away DisCide® Ultra Spray Disinfectant has been demonstrated to from children and pets. effectively disinfect the Flexitouch Plus system. Use DisCide Ultra Spray or similar disinfectant compliant with OSHA’s Bloodborne Cleaning the Flexitouch Plus System Pathogen Standard (29 CFR 1910.1030) and/or registered with the...
  • Page 61: Chapter 10 Troubleshooting And Specifications

    3. To apply the replaceable pad when it is received, place The Flexitouch Plus system contains no serviceable parts. Do not attempt to the replaceable pad of fabric on the loop surface of the perform any unauthorized maintenance or repairs.
  • Page 62 2. Ensure each hose is straightened out and nothing is blocking the connection with the controller unit. * Tactile Medical Customer Service can be contacted toll free at 3. Once all hoses have been checked and 833.3TACTILE (833.382.2845), 7 a.m. to 7 p.m. CT, Monday–Friday.
  • Page 63: Limited Warranty And Service For Home Use

    Kylee access to Bluetooth data. If you are using an Android device, ensure you have granted Kylee access to a period of two (2) years from the date of shipment. Tactile Medical’s location services. During the Bluetooth setup process, ensure...
  • Page 64: Limited Warranty And Service For Facility Use

    Chambers (max) 10.5 Return Policy Mode of Operation Continuous Tactile Medical does not accept returns or provide refunds for any Recalibration not required for the Calibration medical equipment dispensed to patients, including garments/ Flexitouch Plus system sleeves, controller unit or any accessories once the original packaging...
  • Page 65 1kV, 100kHz repetition rate Wireless Technology IEC 61000-4-5 AC 120 VAC/60 Hz ±0.5kV, ±1kV line-to-line The Flexitouch Plus Bluetooth® controllers use Bluetooth Low Energy ±0.5kV, ±1kV, ±2kV line-to- ground (BLE) 4.0+ which complies to IEEE 802.15.1 and uses a Passkey pairing IEC 61000-4-6 AC 120 VAC/60 Hz 3V, 0.15-80MHz, 80% 1kHz AM...
  • Page 66: Device Label

    Section 8.11, Table 11 of the inches (100 cm) with an illumination of 500 lx minimum. IEC 60601-1-2 standard If label reading issues remain, please call Tactile Medical Customer Service toll free at 833.3TACTILE (833.382.2845), 7 a.m. to 7 p.m. CT, FCC Compliance Monday–Friday.
  • Page 67: Clinician-Directed Manual Pressure Adjustment

    ————————————— Clinician-Directed Manual Pressure Adjustment The Flexitouch Plus is designed to allow patients to manually adjust treatment pressures for individual treatment segments in different areas of the body during treatment. Follow the steps outlined below to manually adjust the pressure(s) for the individual treatment segment(s).
  • Page 68 5. Once you have adjusted the pressure for the desired treatment 3. Press the button so the PRESSURE option is highlighted in area(s), use the arrow button so the DONE WITH PRESSURE blue to select the DECREASED, NORMAL or INCREASED options. option is highlighted in blue.
  • Page 69: For Additional Questions

    ƒ Visit: tactilemedical.com ƒ Email: info@tactilemedical.com ƒ Fax: Toll free: 866.435.3949 ƒ Phone: Toll free: 833.3TACTILE (833.382.2845) Hours: 7 a.m. to 7 p.m. CT, Monday–Friday ƒ Mail: Tactile Medical, 3701 Wayzata Blvd, Suite 300 Minneapolis, MN 55416 U.S.
  • Page 70 F: 612.355.5101 tactilemedical.com Tactile Medical and Flexitouch are registered trademarks, and Healing Right at Home is a trademark of Tactile Medical. DisCide® is a registered trademark of Palmero Health Care Corporation. VELCRO® is a registered trademark of Velcro IP Holdings LLC. Used with permission. No part of the contents of this User Guide may be reproduced or transmitted in any way, form or by any means without the written permission of Tactile Medical.

This manual is also suitable for:

Pd32-g3

Table of Contents