Advanced Pneumatic Compression. Flexitouch System MODEL PD32-U

Transcription

1 Advanced Pneumatic Compression Flexitouch System U S E R G U I D E MODEL PD32-U

2 Table of Contents Chapter 1 Before You Get Started How to Contact Tactile Medical Safety Precautions and Explanation of Symbols Indications for Use Contraindications Unpacking Instructions... 5 Chapter 2 The Flexitouch System System Components Programmed Pressure Levels Treating the Lower Extremity Treating the Upper Extremity Treating the Head and Neck Chapter 3 Controller Set-Up Setting Up the Controller Unit Select Your Settings Chapter 4 Garment and Accessory Application Lower Extremity Applying the Full Leg Garment Applying the Full Leg Garment and Trunk Accessory Applying the Calf-Foot Garment and Trunk-Thigh Accessory Chapter 5 Garment and Accessory Application Upper Extremity Applying the Arm Garment Applying the Trunk Accessory and Arm-Shoulder Garment Chapter 6 Garment Application Head and Neck Applying the Head Garment and the Vest for Head and Neck.. 30 Chapter 7 Connecting the Hoses to the Controller Chapter 8 Conducting a Therapy Session Starting the Therapy Session Pausing the Therapy Session Completing the Therapy Session Turning the Controller Unit Off Storing the Flexitouch System Cleaning the Flexitouch System Chapter 9 Troubleshooting and Specifications Troubleshooting Limited Warranty and Service for Home Use Limited Warranty and Service for Facility Use Equipment Lifetime Return Policy Patents Technical Information For Additional Questions... 48

3 CHAPTER 1 Before You Get Started Read the entire guide before attempting to connect or operate this product. Keep this guide for future reference. The Flexitouch System is designed for at-home treatment of lymphedema, chronic edema and chronic wounds. When used daily, the Flexitouch System can help you manage your condition, improve your health, and allow you to enjoy a better quality of life. This guide provides the information needed to set up and use your Flexitouch System. 1.1 How to Contact Tactile Medical If you have questions about the Flexitouch System or require service, contact Tactile Medical. Customer Service: or toll-free (U.S. only) at , Monday through Friday, 7:00am 7:00pm CT. You may also us at info@tactilemedical.com. If you have medical questions, please contact your physician or healthcare provider. 1.2 Safety Precautions and Explanation of Symbols IMPORTANT: Read Instructions Before Using Before attempting to connect or operate this product, please read the entire guide. Keep this guide available for future reference. CAUTION MANUFACTURER S PART NUMBER Rx Only CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare professional. Consult your physician or other healthcare provider for recommendations regarding your therapy program, treatment cycles and/or duration of treatment. Use this product only at the settings prescribed by your healthcare provider. 1 Customer Service Toll-Free:

4 Do NOT Dispose with General Household Waste Tactile Medical complies with the Waste Electric and Electronic Equipment Directive (WEEE) 2002/96/EC. Contact Tactile Medical at or toll-free at (U.S. only) to get disposal instructions. Type BF Applied Part Device Serial Number UL Certification Mark Product Category: Medical Equipment Product Category CCN: PIDF Control Number: 86TN CLASS 1 WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL CE Mark Certification The Flexitouch System, Model PD32-U conforms to the European Medical Device Directive 93/42/EEC. EU Authorized Representative Emergo Europe, Molenstraat 15, 2513 BH, The Hague, The Netherlands Tel: (+31) Fax: (+31) IP21 Flexitouch System complies with IEC60329 regarding degree of protection against water and particulates. EMC Precautions The Flexitouch System is Medical Electrical Equipment that requires installation precautions regarding electromagnetic compatibility (EMC). Installation is to be completed as specified in the Technical Information Section. Beware that portable and mobile RF Communications equipment can affect Medical Electrical Equipment. WARNING: Risk of Electric Shock Do not attempt to service the controller. Such attempts could result in injury or damage to the product, and will void any warranty. Do not disassemble the controller. Use of outlets and power cords that have a ground connection reduces the risk of electric shock. Your controller unit may have been supplied with a hospital-grade power cord. If so, hospital-grade is achieved only when connected to a hospital-grade electrical receptacle. The provided power cord is safe to be used with any residential grounded outlet. Unplug the controller when not in use. The Flexitouch System is to be used indoors only. Do not use the controller near water or while bathing. Do not reach for the controller if it falls into water. Unplug the controller at the electrical outlet immediately. 2

5 WARNING: Risk of Personal Injury Use the controller only for its intended purpose, as directed in this guide. Use accessories only if recommended or supplied by Tactile Medical. Setup the controller in a manner that provides easy access to the power cord should it become necessary to unplug quickly. 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. Keep the power cord away from heated surfaces. Never operate the controller where the cord or tubing harness will present a strangulation or tripping hazard. Strangulation potential: Power cord and tubing bundle should never be placed near or around a person s neck. CAUTION: Risk of Device Damage Never block the ventilation openings on the back or the sides of the controller. Keep the ventilation openings free of debris such as lint and hair. Never operate the controller on a soft surface, such as a bed, couch, or pillow, where the ventilation openings may be blocked. Never drop or insert any object into any opening of the controller. Never use sharp objects, such as pins, scissors or clasps on or near the Flexitouch System. Never use hot devices such as irons or blow dryers, on or near the Flexitouch System. 1.3 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: Lymphedema 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. 3 Customer Service Toll-Free:

6 1.4 Contraindications The Flexitouch System should not be used if you have one or more of the following conditions: Pulmonary edema Thrombophlebitis Congestive heart failure Deep vein thrombosis Episodes of pulmonary embolism Infections and inflammations Acute cancer Conditions in which increased venous and lymphatic return is undesirable The Flexitouch trunk accessory should not be used during pregnancy. The head garment and the 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) Carotid sinus hypersensitivity syndrome 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 Internal jugular venous thrombosis (within 3 months) Increased intracranial pressure or other contraindication to internal or external jugular venous compression Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 8 week post-operative Facial or head and neck dermal metastasis Acute facial infection (e.g., facial or parotid gland abscess) Any condition in which increased venous and lymphatic return is undesirable 4

7 1.5 Unpacking Instructions When your Flexitouch System arrives, allow the controller to reach room 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 begin operation. Included in the box, you should find the following: User Guide Controller unit Garments and accessories needed to treat your condition Power cord (10 maximum) Training DVD Welcome packet The garments and accessories you receive will depend upon your individual therapy requirements. If you are missing any of the items listed for your prescribed treatment, please contact Customer Service. Lower Extremity Treatment The garments and accessories needed for lower extremity treatment may include the following: Full leg garment (available in short petite, short, medium or long) Trunk-thigh accessory (available in short, long or EXT) Calf-foot garment (available in reg or EXT) Trunk accessory Waist extender(s) 5 Customer Service Toll-Free:

8 Upper Extremity Treatment The garments and accessories needed for upper extremity treatment may include the following: Arm/arm-shoulder garment Trunk accessory Waist extender(s) Head and Neck Treatment The garments needed for head and neck treatment may include the following: Head garment Vest for head and neck Labels Each label is located where the tubing attaches to the garment or accessory. It indicates the body area the garment or accessory is to be applied (full leg, trunk, calf-foot, trunk-thigh, chest, arm, head, and vest for head and neck). See Figure 1a. Figure 1a. Label Examples 6

9 CHAPTER 2 The Flexitouch System The Flexitouch System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. NOTE: No special skills, training or knowledge is required to operate the Flexitouch System. 2.1 System Components The Flexitouch System consists of two primary components: Controller The controller is a programmable pneumatic compressor with four connector outlets. Each connector has eight outflow ports in which the garment hoses plug into. Air passes through the hoses, delivering treatment through the sequential inflation and deflation of up to 32 air chambers in the garments. By selecting the appropriate treatment program, calibrated gradient pressure is delivered to the chambers and assists in moving excess fluid out of affected limb(s). Garments and Accessories The air-chambered garments and accessories are made of soft, pliable fabric. They are designed to fit the contours of your body by wrapping around the limb(s) and attaching with hook and loop fasteners. A variety of upper and lower extremity treatment options are available in order to address your specific needs. The upper extremity garment(s) and accessories are used to treat the arm, or arm and core. Depending on your clinical needs, you may be prescribed an arm garment, or arm-shoulder garment and trunk accessory. The head garment and the vest for head and neck are used to treat the head, neck and chest. Depending on your clinical needs, you may be prescribed a head garment and a vest for head and neck. The lower extremity garment(s) and accessories are used to treat the leg or the leg and core. Depending on your clinical needs, you may be prescribed a leg garment, or both a leg garment and trunk accessory. 7 Customer Service Toll-Free:

10 Table 1: Treatment Programs and Therapy Times Upper Extremity Lower Extremity Program Program Display Body Regions Treated Single Cycle Time (min.) Primary Upper Extremity Treatment Programs U1 Full arm & core Trunk, chest, biceps, forearm and hand U4 Arm-shoulder Biceps, forearm and hand U7 Full arm Arm Supplemental Upper Extremity Treatment Programs U2 Trunk ONLY-UPPER Trunk U3 Trunk & chest Trunk and chest U5 Forearm & hand Forearm and hand U6 Hand only Hand Primary Head and Neck Treatment Program H1 Head neck & vest Head, neck & chest 32 1 Supplemental Head and Neck Treatment Program H2 Head only Head, neck 15 1 Primary Lower Extremity Treatment Programs L1 Full leg & core Trunk, thigh, calf and foot 60 1 L4 Full leg plus Thigh, calf and foot L5 Half leg plus Calf and foot L7 Half leg Calf and foot L8 Full leg Thigh, calf and foot Supplemental Lower Extremity Treatment Programs L2 Trunk ONLY-LOWER Trunk L3 Trunk & thigh Trunk and thigh L6 Foot only Foot Available Cycles 2.2 Programmed Pressure Levels Programmed pressure levels in each of the air chambers are based on physiological principles of how lymph fluid moves through the lymphatic system. Your healthcare provider will determine what individual programs are appropriate for you. In certain medical circumstances, your healthcare provider may wish to increase the pressure settings specifically for your hand or foot regions. The Flexitouch controller allows for selection of INCREASED pressure settings. Please consult with your healthcare provider before changing those settings. 8

11 2.3 Treating the Lower Extremity Figure 2a: Full Leg Treatment Program L8 Providing traditional leg treatment, this option moves excess lymphatic fluid in a distal to proximal (foot to top of thigh) direction via multiple chambers in a continuous wave-like motion. (Approximate treatment time: 45 minutes) Full Leg directs fluid from toes to top of thigh in one continuous motion 9 Customer Service Toll-Free:

12 Figure 2b: Full Leg and Core Treatment Program L1 This treatment option provides the ability to deliver therapy to both the leg and trunk regions when clinically appropriate. Incremental proximal clearing of lymphatic fluid in the trunk, thigh, calf and foot regions is followed by delivery of the traditional full leg treatment. (Approximate treatment time: 60 minutes) 1 1. Trunk directs fluid from top of the thigh to waist 5. Full Leg 2. Thigh directs fluid from knee to top of the thigh to Trunk directs fluid from toes to top of waist in one continuous motion Calf directs fluid from ankle to knee 4. Foot directs fluid from toes to ankle 10

13 Figure 2c: Full Leg Plus Treatment Program L4 This treatment option provides the ability to deliver expanded therapy to the leg when clinically appropriate. Incremental proximal clearing of lymphatic fluid in the thigh, calf and foot regions is followed by delivery of the traditional full leg treatment. (Approximate treatment time: 45 minutes) Thigh directs fluid from knee to top of thigh 2. Calf directs fluid from ankle to knee 4. Full Leg directs fluid from toes to top of thigh in one continuous motion Foot directs fluid from toes to ankle 11 Customer Service Toll-Free:

14 2.4 Treating the Upper Extremity Figure 2d: Full Arm Treatment Program U7 Providing traditional arm treatment, this option moves excess lymphatic fluid in a distal to proximal (hand to top of bicep) direction via multiple chambers in a continuous wave-like motion. (Approximate treatment time: 30 minutes) Arm begins at fingertips and ends at top of bicep in one continuous motion 12

15 Figure 2e: Full Arm and Core Treatment Program U1 This treatment option provides the ability to deliver therapy to the arm, chest and trunk regions when clinically appropriate. Incremental proximal clearing of lymphatic fluid in the trunk, chest, bicep, forearm and hand regions is followed by delivery of the traditional full arm treatment. (Approximate treatment time: 60 minutes) 2. Chest directs fluid from shoulder toward waist 1. Trunk directs fluid from waist toward top of thigh Biceps directs fluid from elbow toward shoulder 5. Hand directs fluid from fingers toward wrist 4. Forearm directs fluid from wrist toward elbow 6 6. Full Arm and Trunk directs fluid from fingers to the top of thigh in one continuous motion 13 Customer Service Toll-Free:

16 2.5 Treating the Head and Neck Figure 2f: Head and Neck Treatment Program H1 This treatment option provides the ability to deliver therapy to the head and neck and chest when clinically appropriate. (Approximate treatment time: 32 minutes) Head directs fluid from head toward neck 2. Neck directs fluid from neck toward chest 1. Chest directs fluid from the chest towards under arm area 4. Full Head, Neck and Chest directs fluid from head to the under arm area in one continuous motion 4 14

17 CHAPTER 3 Controller Set-Up The Flexitouch System uses a controller and a set of garments and accessories to provide therapy. In this chapter you will learn how to set up the controller and select the proper settings prior to receiving therapy. You will learn how to apply the garments in Chapter Setting Up the Controller Unit Follow the steps outlined below: 1. Find an appropriate location for the controller unit. Place the controller on a sturdy, flat surface near a grounded electrical outlet. Position the device so you have easy access to the plug. 2. Plug the power cord into the power cord inlet on the back of the controller. Then, plug the three-pronged plug into a grounded 120 Volt AC or 230 Volt AC electrical outlet. (Figure 3a.) Figure 3a. Grounded AC Outlet Grounded Outlet Three-pronged Plug NOTE: The power cord required for your country may be different than shown. WARNING: RISK OF ELECTRICAL SHOCK This equipment is intended to be electrically grounded and is supplied with a hospitalgrade power cord that contains a three-pronged plug (a plug with a grounding pin). This plug is designed for use only with a grounded 120 Volt AC or 230 Volt AC outlet. Only use the power cord supplied with your unit. Do not attempt to cut off, bend, or remove the ground connection or alter the plug in any way, as this may result in an electrical hazard. 15 Customer Service Toll-Free:

18 3.2 Select Your Settings Follow the steps outlined below to select the settings prescribed by your healthcare provider: NOTE: The controller unit will store the settings used for the last therapy session and will automatically recall these settings. Therefore, in most situations the following settings will not need to be modified from one treatment to the next. 1. Turn the controller ON. Turn the controller unit on by pressing the brown ON/OFF button located on the front panel. See Figure 3b on next page. 2. Select the program. Press the left or right PROGRAM arrow buttons to scroll through the available programs, until the desired program is displayed. (See Table 1 for a list of all the available programs.) 3. Select the accessory size. Press the GARMENT SIZE arrow button to toggle between the sizes. Select the appropriate size of garment or accessory that you will use and indicated on the label. *(See Table 2 on next page for a partial list of available garment and accessory sizing combinations). 4. Select the pressure settings. In most cases, select the NORMAL pressure setting. If your healthcare provider prescribes increased treatment pressure specifically in your hand or foot, press the PRESSURE SETTING arrow button to toggle between NORMAL and INCREASED to select the appropriate setting. 5. Select the therapy cycles. The THERAPY CYCLES setting specifies the number of times the selected program will repeat without interruption. Press the THERAPY CYCLES arrow button until it reaches the correct number of cycles as directed by your healthcare provider. For programs L1 and U1, you will only be able to select a THERAPY CYCLE of 1. During and throughout therapy selection, the approximate therapy time remaining will be displayed in the lower right-hand corner of the controller screen. After you have selected the necessary settings, you are ready to apply the garments. 16

19 Figure 3b. Controller Unit Front Panel Program Garment Time Remaining Pressure Therapy Cycles Start/Pause On/Off Connector Number Table 2: Garment and Accessory Size Selections Lower Extremity Upper Extremity Head & Neck LONG FULL LEG SHORT ARM SMALL HEAD/SMALL VEST MEDIUM FULL LEG LONG ARM SMALL HEAD/MEDIUM VEST SHORT FULL LEG SZ 1 CHEST/SHORT ARM SMALL HEAD/LARGE VEST TRUNK/SHORT FULL LEG SZ 1 CHEST/LONG ARM MEDIUM HEAD/SMALL VEST TRUNK/MED FULL LEG SZ 2 CHEST/SHORT ARM MEDIUM HEAD/MEDIUM VEST TRUNK/LONG FULL LEG SZ 2 CHEST/LONG ARM MEDIUM HEAD/LARGE VEST SHORT TRUNK/REG CALF SZ 3 CHEST/SHORT ARM LARGE HEAD/SMALL VEST SHORT TRUNK/EXT CALF SZ 3 CHEST/LONG ARM LARGE HEAD/MEDIUM VEST LONG TRUNK/REG CALF SZ 4 CHEST/SHORT ARM LARGE HEAD/LARGE VEST LONG TRUNK/EXT CALF SZ 4 CHEST/LONG ARM EXT TRUNK/REG CALF EXT TRUNK/EXT CALF * NOTE: The short petite full leg garment utilizes the short full leg garment size setting on the controller. 17 Customer Service Toll-Free:

20 CHAPTER 4 Garment and Accessory Application Lower Extremity Before starting, be sure you are using the recommended garments and accessories for your condition. Before applying the garments and accessories, prepare yourself for an uninterrupted therapy session these typically last about one hour. CAUTION To avoid skin irritation that may result from contact with the nylon material, wear lightweight, loose-fitting (non-elastic) cotton clothing, (example: scrubs, stockinette); for head and neck garments a face mask or balaclava. If skin irritation develops, consult with your doctor. Lymph fluid is moved through the vessels in the skin. It is important to avoid wearing anything during therapy that may hamper the lymph flow. These items include: Belts Jewelry Restrictive clothing such as: - Elastic-banded underwear - Compression bandaging - Elastic-banded socks - Compression garments - Bra 4.1 Applying the Full Leg Garment If you have only received a garment labeled full leg, follow the preparation and application instructions below. Full Leg Garment Preparation: 1. Unfold and place the full leg garment on the bed or sofa so that the hose seam will run along the back of your leg. 18

21 Full Leg Garment 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). 3. Begin by wrapping the foot section snugly around your toes and the arch of your foot. Secure the fabric in place with the hook fastener tabs. 4. Next wrap your ankle, following its contours. Secure the fabric with the hook fasteners. 5. 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 hook fastener tabs as necessary to get a well-contoured fit. 6. Finally, place a couple of pillows under your calf and foot to elevate them just above your hips for optimal treatment. Place the hoses alongside your body so they are easy to reach when attaching them to the controller unit. You are now ready to attach the hoses to the controller. See Chapter 7 for further instructions. Figure 4.1.a. Applying the Full Leg Garment Customer Service Toll-Free:

22 4.2 Applying the Full Leg Garment and Trunk Accessory If you have received garments and accessories labeled full leg and trunk, follow the preparation and application instructions below. Full Leg Garment and Trunk Accessory Preparation: NOTE: If you are treating both legs, you will only receive one trunk accessory, which is designed to treat either side of the body. You will have to follow these directions for both sides. 1. Unfold and place the trunk accessory and leg garments on a bed or sofa. 2. Position the trunk accessory so that when you sit on it, the hose seam will run along the side of your hip and the tubing harness will be at your waist. 3. Position the leg garment so that the hose seam will run up the back of your leg. 4. When using both the leg garment and trunk accessory, make sure they overlap near the thigh by a couple of chambers. This ensures they are properly applied so there will be no gap in treatment. 5. If you need a waist extender, attach it to the trunk accessory. Full Leg Garment Application: 6. Sit down and place your leg on the garment, centering your heel between the second set of fabric notches (when counting from the toe of the garment). 7. Begin by wrapping the foot section snugly around your toes and the arch of your foot. Secure the fabric in place with the hook fasteners. 8. Next wrap your ankle, following its contours. Secure the fabric with the hook fastener tabs. Figure 4.2.a. Applying the Full Leg Garment and Trunk Accessory WAIST EXTENDER 6 20

23 9. 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 hook fastener tabs as necessary to get a well-contoured fit. 10. Finally, place a couple of pillows under your calf and foot to elevate them just above your hips for optimal treatment. Place the hoses alongside your body so they will be easy to reach when you are ready to attach them to the controller unit. Trunk Accessory Application: To receive a full therapy treatment, the full leg garment and trunk accessory must overlap at the thigh by a couple of chambers. 11. Before you begin wrapping the trunk accessory, check to make sure the U-shaped notch (see 11 below) on the accessory will be centered at the groin area when properly applied. 12. Begin applying the trunk accessory by starting with the thigh section. Bring the fabric up between your thighs, wrapping snugly as you follow the crease where your thigh meets your trunk. Use the hook fastener tabs to secure the fabric in position. 13. Lay back with your head on the pillow. Grasp the top of the trunk fabric, wrapping it over your abdomen. Bring the fabric with the hook fasteners over your abdomen, in an upward direction for the best fit. Attach the hook fastener tabs so the fabric is securely in place. You are now ready to attach the hoses to the controller. See Chapter 7 for further instructions. Figure 4.2.b. Fully Applied Full Leg Garment and Trunk Accessory Customer Service Toll-Free:

24 4.3 Applying the Calf-Foot Garment and Trunk-Thigh Accessory If you have received garments and accessories labeled calf-foot and trunk-thigh, follow the preparation and application instructions below. (The labels applicable to this section could read: EXT trunk-thigh, long trunk-thigh or short trunk-thigh and EXT calf-foot or reg calf-foot.) Calf-Foot Garment and Trunk-Thigh Accessory Preparation: 1. Unfold and place the trunk-thigh accessory on the bed or sofa, positioned so when you sit on it, the seam will be along the outside of your leg. 2. If you need a waist extender, attach it to the trunk accessory. 3. Place the calf-foot garment on the bed so that it overlaps the trunk-thigh accessory by a couple of chambers and so the hose seam will run along the back of your leg. Calf-Foot Garment Application: 4. Sit down and place your heel into the heel cup area of the garment. 5. Begin wrapping the foot section with the non-hook fastener side of the fabric. Snugly wrap the arch of the foot and the toes. Secure the fabric with the hook fastener tabs. 6. Grasp the non-hook fastener side of the calf fabric. Wrap this section by starting mid-calf then move up and down your leg making sure the fabric is smooth and there are no gaps around the toes, ankle and knee. Secure the fabric with the hook fastener tabs, Figure 4.3.a. Applying the Calf-Foot Garment starting at the midpoint of the calf and continuing to attach the hook fasteners up and down your calf. 7. If necessary, readjust the fasteners to obtain a well-contoured and comfortable fit WAIST EXTENDER 4 22

25 8. Place a couple of pillows under your calf and foot to elevate them just above 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. Trunk-Thigh Accessory Application: 9. Check to make sure the U-shaped notch on the trunk accessory will be centered on the groin area when fully applied. 10. Hold the non-hook fastener side of the thigh accessory at the midpoint and bring it up between your thighs. Starting mid-thigh, wrap this section over your thigh so that the fabric is snug and follows the crease where your thigh meets your trunk. 11. Grasp the hook fastener side of the thigh accessory at the midpoint wrapping it over the non-hook fastener fabric. Secure the hook fastener tabs starting at the midpoint and working up and down your thigh. Adjust the hook fastener tabs as necessary to ensure a snug fit without gaps, paying particular attention to where the trunk-thigh accessory and calf-foot garment meet. 12. Lay back and snugly wrap the non-hook fastener side of the trunk fabric over your abdomen. Bring the hook fastener side of the fabric as far as you can over your trunk. Secure the hook fastener tabs. You are now ready to attach the hoses to the controller. See Chapter 7 for further instructions. Figure 4.3.b. Fully Applied EXT Lower Extremity Garment Set Customer Service Toll-Free:

26 CHAPTER 5 Garment and Accessory Application Upper Extremity Before starting, be sure you are using the recommended garment(s) and accessory(ies) for your condition. Before applying the garments and accessories, prepare yourself for an uninterrupted therapy session these typically last about one hour. CAUTION To avoid skin irritation that may result from contact with the nylon material, wear lightweight, loose-fitting (non-elastic) cotton clothing, (example: scrubs, stockinette); for head and neck garments a face mask or balaclava. If skin irritation develops, consult with your doctor. Lymph fluid is moved through the vessels in the skin. It is important to avoid wearing anything during therapy that may hamper the lymph flow. These items include: Belts Jewelry Restrictive clothing such as: - Elastic-banded underwear - Compression bandaging - Elastic-banded socks - Compression garments - Bra 5.1 Applying the Arm Garment If you have only received a garment labeled arm, follow the preparation and application instructions below. Arm Garment Preparation: 1. In preparation for donning the arm garment, loosely form the garment into a cone shape and fasten the hook tabs. NOTE: Adjust the tabs so that you will be able to slide your affected arm into the garment easily. 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. 24

27 Arm Garment Application: 3. Slide your arm into the pre-shaped cone, making sure the tabs run along the side of the garment closest to your torso. 4. Pull the arm garment up toward your biceps making sure that your fingertips remain fully enclosed in the garment. 5. Readjust the tabs on the inside of the arm garment to obtain a well-contoured fit around the arm. Pay particular attention to snugly fitting the contours of the wrist and elbow areas. You are now ready to attach the hoses to the controller. See Chapter 7 for further instructions. Figure 5.1.a. Preparing the Arm Garment Figure 5.1.b. Adjusting the Arm Garment for a Snug Fit Figure 5.1.c. Fully Applied Arm Garment Applying the Trunk Accessory and Arm-Shoulder Garment If you have received garments and accessories labeled trunk and arm-shoulder, follow the preparation and application instructions below. The upper extremity garments and accessories work together to deliver effective therapy. It is easiest to apply them in the order presented: trunk first, and arm-shoulder last. 25 Customer Service Toll-Free:

28 Trunk Accessory Preparation: NOTE: If you are treating both arms, you will only receive one trunk accessory, which is designed to treat either side of the body. You will have to follow these directions for both sides. 1. Place the trunk accessory on the bed or sofa. Position it so that when you sit on it, the seam will run along the side of your leg with the tubing harness near your waist. 2. If you need a waist extender, attach it to the trunk accessory. Trunk Accessory Application: 3. Before you begin wrapping the trunk accessory, check to make sure the U-shaped notch (see 3 below) on the accessory will be centered at the groin area when properly applied. 4. Begin applying the trunk accessory by starting with the thigh section. Bring the fabric up between your thighs, wrapping snugly as you follow the crease where your thigh meets your trunk. Use the hook fastener tabs to secure the fabric in position. 5. Lay back with your head on the pillow. Grasp the top of the trunk fabric, wrapping it over your abdomen. Bring the fabric with the hook fasteners over your abdomen, in an upward direction for the best fit. Attach the hook fastener tabs so the fabric is securely in place. Figure 5.2.a. Fully Applied Trunk Accessory 1 3 The trunk section must fit close to the groin area. 2 WAIST EXTENDER 4 26

29 Arm-Shoulder Preparation: 6. In preparation for donning the arm-shoulder garment, loosely form the arm portion of the garment into a cone shape and fasten the hook tabs. NOTE: Adjust the tabs around the biceps section so you will be able to slide your affected arm into the garment easily. 7. Unfasten the chest strap on the front of the garment so you are able to apply the garment. Arm-Shoulder Application: 8. Slide your arm into the pre-shaped cone, making sure the tabs run along the front of the garment. NOTE: Pay particular attention to snugly fitting the contours of the wrist and elbow areas. 9. Pull the arm portion of the garment up toward your shoulder, making sure your fingertips remain fully enclosed in the garment. 10. Ensure the chest flap attached to the arm piece crosses the center line of your chest and is flat against your chest. Figure 5.2.b. Preparing the Garment Figure 5.2.c. Applying the Garment The arm section must fit close to the armpit Customer Service Toll-Free:

30 11. Place your free hand (extremity not being treated) in the pocket located at the end of the chest strap, wrap it around the front of your chest, and snugly secure it to the chest flap to obtain a well-contoured fit. 12. Readjust and tighten the hook fasteners on the biceps, under the arm, and on the arm to obtain a well-contoured fit. Figure 5.2.e. Applying the Arm-Shoulder Garment 11 Figure 5.2.f. Ensure a Well-Contoured Fit 12 28

31 Fully Applied Arm-Shoulder Garment 13. Properly applied, the garment and accessories will follow the contours of your body and fit snugly, yet comfortably. Make any necessary adjustments after you lie down to ensure a well-contoured fit. Figure 5.2.g. Fully Applied Arm-Shoulder Garment 14. Use a pillow to elevate your arm slightly above your torso during treatment and angle your arm about 45 degrees out from the side of your body. You are now ready to attach the hoses to the controller. See Chapter 7 for further instructions. Figure 5.2.h. Fully Applied Trunk and Arm-Shoulder Garment 29 Customer Service Toll-Free:

32 CHAPTER 6 Garment Application Head and Neck Before starting, be sure you are using the recommended garment(s) for your condition. Before applying the garments, prepare yourself for an uninterrupted therapy session these typically last minutes. CAUTION To avoid skin irritation that may result from contact with the nylon material, wear lightweight, loose-fitting (non-elastic) cotton clothing, (example: scrubs, stockinette); for head and neck garments a face mask or balaclava. If skin irritation develops, consult with your doctor. Lymph fluid is moved through the vessels in the skin. It is important to avoid wearing anything during therapy that may hamper the lymph flow. These items include: Belts Jewelry Restrictive clothing such as: - Elastic-banded underwear - Compression bandaging - Elastic-banded socks - Compression garments - Bra 6.1 Applying the Head Garment and the Vest for Head and Neck If you received garments labeled head and vest for head and neck, follow the preparation and application instructions below. Head Garment Preparation and 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. 2. Pull the forehead strap through the plastic loop. Tighten by pulling on the forehead strap and secure by attaching the hook fastener of the forehead strap to the inner head strap. (Figure 6.1.a.) 30

33 3. Conform the nose piece across the bridge of the nose and attach the free hook fasteners to the side of the head garment to ensure good contact of garment to the cheeks. Adjust garment so it doesn t come into contact with your eyes. (Figure 6.1.b.) 4. Adjust the right inner chin strap to fit snugly under the chin. (Figure 6.1.c.) 5. Adjust the left outer chin strap over the top of the right inner chin strap and fasten using the hook fastener. (Figure 6.1.d.) Figure 6.1.a. Attach Hook Fastener to Inner Head Strap Figure 6.1.b. Conform Nose Piece Across the Bridge of the Nose Figure 6.1.c. Adjust Right Inner Flap Under Chin Figure 6.1.d. Attach Hook Fasteners of Left Outer Chin Flap 31 Customer Service Toll-Free:

34 Vest for Head and Neck Preparation and Application: 6. Attach the back straps to the back flap of the vest garment so it is shaped like a vest. 7. Slide your arms through the arm holes of the vest garment as you would a jacket. 8. Align both sides of the front zipper at the bottom of the vest garment and zip up the front of the garment to the collar opening. 9. To adjust the fit of the vest garment around the waist, place hands inside the pockets of the waist flaps and adjust the placement of the hook fastener pads on each side of the waist to achieve a snug fit. To allow for easy garment removal, do not pull the waist flaps across the zipper in the front of the garment. Figure 6.1.e. Slide Arms Through the Holes like a Vest Figure 6.1.f. Adjust Fit by Adjusting the Placement of the Velcro Pads and Round Closure Dials To tighten the vest garment around the waist, rotate the round closure dials on the waist flaps of the garment (Figure 6.1.f and 6.1.g). 11. To loosen the vest garment around the waist, pull out on the round closure dials located on both sides of the garment, extend the closure laces by pulling the back of the garment away from the hook fastener pads on the front of the garment. Push the closure dials in until you hear a click to secure them. (Figure 6.1.h.) Figure 6.1.g. Rotate Closure Dial to Tighten Figure 6.1.h. Pull Out Closure Dial to Loosen Laces 32

35 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 zipper, and are designed to help the neck chamber of the garment maintain good contact with your neck during treatment. The collar tabs do not need to be readjusted at the start of each therapy session if you achieve a snug fit when initially contouring the garment. Figure 6.1.i. Adjust collar tabs Figure 6.1.j. Adjust Hook Fastener Tabs on Back Panel To achieve additional fit of the garment around the waist, remove the vest garment and adjust the placement of the hook fastener straps on the back panel of the vest. Move the hook fastener straps outwards to make the vest larger or inwards to make the garment smaller. (Figure 6.1.j.) Fully Applied Head Garments and Vest for Head and Neck: 14. Properly applied garments will follow the contours of your body and fit snugly yet comfortably. To ensure they fit well, you may need to re-adjust when you sit and recline. 15. Sit in a soft-backed chair or recline at up to a 45-degree angle. You are now ready to attach the hoses to the controller. Refer to Chapter 7 of the Flexitouch User Guide for further instructions. 33 Customer Service Toll-Free:

36 CHAPTER 7 Connecting the Hoses to the Controller The final step before therapy can be delivered is connecting the hoses to the controller unit. Notice that both the hose latches and the ports on the controller unit are numbered 1 through 4. When connected properly, latch number 1 will connect to port number 1, and so on. NOTE: One or more of the ports will be capped if your prescribed therapy does not use the port(s). Do not remove the port cap(s). Figure 7a. Hose Connector Latch Top Ramp Connector Collar Bottom Follow the steps below to attach the hoses to the controller: 1. Hold the hose connector by the tabs on the back of the latch making sure that the numbers are facing up. 2. Gently squeeze the tabs to widen the front end of the hose connector. (Figure 7b.) Figure 7b. Corresponding Hose Connector with Controller Connector Numbered Controller Connector Controller Notch Numbered Connector 34

37 3. Align the numbered latch with the notch on the corresponding controller port. 4. Reposition your hand so that your thumb and fingers are positioned on the top and bottom latch ramps, this enables you to slide the latch. (Figure 7c.) Figure 7c. Proper Handling of the Hose Connector Reposition your hand so it is now pushing forward with the collar against the ramps on the latch. 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 connected. Two clicks will be heard, one for the top and one for the bottom latch. (Figure 7d.) Figure 7d. Properly Connecting the Latches 6. Repeat for all connectors required for your prescribed treatment. (Figure 7e, 7f and 7g on next page.) 35 Customer Service Toll-Free:

38 Figure 7e. Fully Attached Hose Connectors When Full Leg Treatment is Prescribed Figure 7f. Fully Attached Hose Connectors When Full Arm Treatment is Prescribed Figure 7g. Fully Attached Hose Connectors When Both Extremity and Core Treatment are Prescribed NOTES: Holding the back of the controller may help to stabilize the unit as you attach the harness connectors. If you are having trouble connecting the latches, try connecting the bottom latch first then tipping the top latch into place. You may see black numerical markings through the tubing harness. This is normal and does not affect performance. 36

39 CHAPTER 8 Conducting a Therapy Session 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. Then, begin the process of starting your therapy session using the instructions outlined below. CAUTION To achieve maximum benefit from your session, it should be completed without interruption. Once started, the controller program settings cannot be changed without turning off the controller. 8.1 Starting the Therapy Session 1. Prepare yourself for an uninterrupted therapy session. 2. Lay down on your back with your hips and legs positioned straight. Do not sit in a chair or bend your affected limbs during the therapy session. 3. Elevate the affected limb on a pillow approximately five inches above your hip. 4. Check your program settings to ensure you have selected the correct program. 5. When properly positioned, press the START/PAUSE button on the controller to begin the therapy session. (See Figure 3b for an illustration of the controller unit front panel.) 6. For best results, relax and take deep abdominal breaths during the therapy session. 8.2 Pausing the Therapy Session If you need to interrupt your therapy session for any reason, press the START/ PAUSE button. (See Figure 3b for an illustration of the controller unit front panel.) The controller will remain paused for fifteen minutes. After that time, the controller will power down, requiring you to restart your session. To resume therapy, press the START/PAUSE button again. 37 Customer Service Toll-Free:

40 8.3 Completing the Therapy Session The therapy program will stop automatically when the treatment has been completed and TIME REMAINING will display DONE. 8.4 Turning the Controller Unit Off When your treatment is complete, turn the controller unit off by pressing the ON/OFF button located on the front panel. 8.5 Storing the Flexitouch System To store the Flexitouch System, follow the steps outlined below: 1. Unplug the power supply cord from the controller and from the electrical outlet. 2. Store the garments and accessories by first coiling the harnesses for each of the supplied garments or accessories. Avoid kinking the tubing. It is preferable to store them by laying them flat. Do not stack anything on top of them. 3. Store the controller, garments and accessories in a cool, dry place. Keep them out of excessive heat or cold. Store them away from children and pets. 8.6 Cleaning the Flexitouch System To clean the controller unit and/or garments and accessories, follow the steps outlined below. Cleaning the Controller Unit The controller is to be cleaned as needed using a damp cloth and mild household cleaner. 1. Unplug the power supply cord from the electrical outlet. 2. Wipe all accessible surfaces, including the power cord. 3. After cleaning, allow the unit to dry completely prior to using. WARNING: RISK OF ELECTRICAL SHOCK Unplug the power supply cord from the electrical outlet prior to cleaning the controller. Allow the controller to dry completely prior to connecting the power cord to the electrical outlet. 38

41 Cleaning the Garments and Accessories 1. A lint brush or roller may be used to remove particles. 2. The garments and accessories may be spot-cleaned using a damp cloth and a mild detergent. 3. Allow garments and accessories to dry thoroughly prior to using. CAUTION Do not submerge. Do not machine wash. Do not disassemble. Do not dry clean. Do not machine dry. Do not autoclave. Do not iron. Disinfecting the Flexitouch System CAUTION: Follow instructions and warnings as issued by manufacturer of any disinfecting product. DisCide Ultra Spray Disinfectant has been demonstrated to effectively disinfect the Flexitouch System. Use DisCide Ultra Spray or similar disinfectant compliant with OSHA s Bloodborne Pathogen Standard (29 CFR ) and/or registered with EPA. To disinfect the Flexitouch system, including garments, controller or accessories between patient use, or if there are visible biological contaminants or visible stains, the following steps are recommended: 1. Clean any visible blood or body fluids from the surface of the garment. 2. Thoroughly wet surface with DisCide ULTRA Disinfecting Spray. 3. Allow surfaces to remain wet for one minute and then allow to air dry. 39 Customer Service Toll-Free:

42 CHAPTER 9 Troubleshooting and Specifications If you experience a problem with the Flexitouch System, refer to the following information for assistance. If the information in Table 3 does not help solve the problem, call Customer Service at (U.S. only) or Troubleshooting Table 3: Troubleshooting Issue Controller does not function or display does not illuminate Recommended Solution 1. Disconnect the power cord from the back of the controller and then reconnect. Ensure that the power cord is fully inserted in both the power inlet on the back of the controller and the wall outlet. 2. Press the ON/OFF button. 3. The display s backlight will illuminate and the program options will be displayed. 4. Check fuses located in the drawer under the power cord inlet. If fuses are blown, replace the fuses using fuses as specified by the device label. If needed, please contact Customer Service for fuses and replacement instructions. Cannot change PROGRAM or other settings The chambers do not fill with air Hook fasteners do not stay closed Once you start a treatment, settings cannot be changed until: The treatment program has completed and DONE is displayed, or The ON/OFF button is pressed. To change program settings, first press the ON/OFF button. Then settings may be adjusted as described in this guide. REMEMBER: To save the settings on the controller, press the START/PAUSE button, and begin a therapy session. 1. Verify the correct program has been selected and press the START/PAUSE button. 2. Verify that the connectors are attached to the correct controller connectors. 3. Ensure that both upper and lower connector latches are engaged. 4. If the chambers still do not fill, turn the machine off, detach the connectors, and turn the machine on again. 5. Press the START/PAUSE button to begin a treatment session. If you feel air coming out of the connectors, reattach the connectors and check again. With continued use, the outside of the fabric will become worn, and the Velcro hook fasteners may become filled with debris. 1. Clean debris from the Velcro hook fasteners using a stiff brush, such as a toothbrush, lint roller, or patting it with tape. 2. Contact Tactile Medical for closure straps. Closure straps will assist in holding the fabric closed by allowing you to attach to an unworn part of the fabric. 40

43 Table 3: Troubleshooting (continued) Issue Chambers are not filling in the expected pattern Recommended Solution 1. Verify that the connectors have been attached to the controller, with both the top and bottom latches securely engaged. 2. Verify that the connectors are attached to the correct controller connectors by checking corresponding numbers. 3. Verify that the correct program and garment size have been selected. NOTE: The first half of many of the available programs have sections that do not inflate adjacent chambers sequentially. Chambers pressures are higher or lower than expected Chambers remain inflated Controller runs longer than expected Latches have broken or become disconnected from garment connectors There is no short petite garment size selection on my controller The controller makes an abnormal noise 1. Verify that the correct program and garment size have been selected. 2. Adjust the fit of the garment, ensuring no folds or kinks are in the fabric. 3. Check to be sure the latches are firmly in place and attached to the correctly numbered port. It is normal for a small amount of air to remain in the chambers between inflations, giving the garment or accessory a puffy appearance. If the chambers remain fully inflated: 1. Ensure that the tubing is not kinked or pinched. 2. Disconnect the connectors and the chambers should deflate. The session length is controlled by the specific program selected and the number of therapy cycles chosen. 1. Verify that the selected PROGRAM and THERAPY CYCLES are as recommended by your healthcare provider. 2. Upon completion of all treatment sessions, verify that the display indicates DONE in the display screen area where TIME REMAINING appears. 3. If the controller continues to operate beyond the time when DONE is displayed, or if the TIME REMAINING indicated by the controller is incorrect, call Customer Service. NOTE: New program settings are stored in memory only after you press the START/PAUSE button to initiate the treatment program. Latches can be replaced or reattached. Please call Customer Service for instructions. The short petite full leg garment utilizes the short full leg garment size setting on the controller. 1. Stop the treatment session by pressing the START/PAUSE button. 2. Verify the noise has stopped. 3. Ensure the hoses from your garments are not kinked or pinched. 4. Check the program selection and make sure the program being run corresponds to the garments being used. Make sure the selected garment size matches the garments being used. 5. Check to make sure the correct garment connectors are connected to the correct port in the controller (e.g., the #4 garment connector is connected to the #4 port on the controller) 6. Restart the treatment by pressing the START/PAUSE button. 7. If the noise continues, contact Customer Service. 41 Customer Service Toll-Free:

44 9.2 Limited Warranty and Service for Home Use Tactile Medical provides a warranty for the Flexitouch System. The Flexitouch Controller is warranted to be free from defects in material and workmanship for a period of two (2) years from the date of purchase. All other accessories, garments and supplies related to the use of the Flexitouch System are warranted 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 warranty is expressly limited to the replacement of defective parts that cannot, in the sole discretion of Tactile Medical, be repaired. Replacement parts may be new or refurbished parts as solely determined by Tactile Medical. No representation or other affirmation of fact set forth in this agreement, including but not limited to statements regarding suitability for use or performance of the Flexitouch System, shall be deemed to be a warranty or representation by Tactile Medical for any purpose, nor give rise to any liability or obligation of Tactile Medical. EXCEPT FOR THE FOREGOING, TACTILE MEDICAL MAKES NO OTHER WARRANTY. THE WARRANTIES SET FORTH HERE ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY THE MANUFACTURER, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE AND ALL OBLIGATIONS OR LIABILITIES ON THE PART OF TACTILE MEDICAL FOR DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE USE, REPAIR OR PERFORMANCE OF THE Flexitouch System. IN NO EVENT SHALL TACTILE MEDICAL BE LIABLE FOR ANY SPECIAL, DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES. Some states, provinces or countries do not allow exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply. This warranty is available only to the original user and is not transferable. Repairs or alterations to the product not conducted by Tactile Medical shall void these warranties. These warranties do not cover failures due to improper or negligent use of the product. These warranties provide specific legal rights; there may be other available rights, which may vary by state, province or country. 9.3 Limited Warranty and Service for Facility Use Contact Tactile Medical for information regarding the service agreements available to facilities. 9.4 Equipment Lifetime The expected equipment lifetime is equal to the warranty period. 9.5 Return Policy The Flexitouch controller unit may be returned within 30 days of the user s receipt of the device if the user is not satisfied with the equipment. Upon receipt of the controller, the Company will issue a full refund for the amount paid for controller purchase. The refund will be issued to the third party payer and/or person who provided payment. Returns are not accepted nor refunds issued for garments, once opened. If the garment is unused and packaging unopened, it may be returned for a full refund within the 30-day period. 42

45 9.6 Patents The Flexitouch System is protected by the following United States patents: * 6,179,796 6,645,165 6,860,862 6,966,884 *Additional patents are pending. Tactile Medical reserves the right to modify product specifications as part of its continuing program of product development and quality improvement. 9.7 Technical Information The Flexitouch System has the following characteristics: Model Number Input Voltage/Frequency Current Fuse Rating Controller Size Controller Weight Outer Fabric Table 4: Flexitouch System Technical Information Therapy Programs 15 Chambers (max) 32 Mode of Operation Calibration Electromagnetic Interference (EMI) Electromagnetic Compatibility (EMC) Operating Atmospheric Pressure PD32 U VAC 50/60 Hz 1.0 A Maximum T 1AH, 250V (Only replace fuses with 1 Amp high breaking capacity, time lag 250V minimum fuses) 5.5 x 12.3 x 10.5 (140 mm x 312 mm x 267 mm) 8 lbs. (3.5 kgs) 100% nylon, not made with natural rubber latex Continuous Recalibration not required for the Flexitouch System The Flexitouch System was designed to minimize the effects of external EMI upon the device and to minimize the effect upon the environment from the device. The device conforms to the appropriate EMC standards. See Tables 6, 7 and to 1060 hpa Device Transport and Storage Temperature Limits Device Operating Temperature Limits Device Operating Humidity Limits 43 Customer Service Toll-Free:

46 Table 5: Flexitouch System Classification Information US FDA Medical Device Class II per 21CFR & 21 CFR Canada Medical Device European Union Medical Device Protection Against Electric Shock Hazard Protection Against Fluid Ingress Applied Part Class II per Canadian Medical Devices Regulations SOR/ Class IIa per Medical Devices Directive 93/42/EEC Class I per UL/EN/IEC IP21 BF Quality Assurance Table 6: Flexitouch System Conformance Information FDA 21 CFR 820 QSR ISO Safety UL/EN/IEC CAN/CSA C22.2 No Electromagnetic Compatibility (EMC) EN Waste Electrical & Electronic Equipment (WEEE) Restriction of Hazardous Substances (RoHS) Directive 2002/96/EC Directive 2002/95/EC Table 7: Guidance and Manufacturer s Declaration Electromagnetic Emissions The PD32-U Flexitouch System is intended for use in the electromagnetic environment specified below. The customer or the user of the Flexitouch System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Complies The Flexitouch System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Flexitouch System is suitable for use in all establishments, including domestic establishments and those connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 44

47 Table 8: Guidance and Manufacturer s Declaration Electromagnetic Immunity 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 Test Electrostatic discharge (ESD) IEC Electrical fast transient/burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply lines IEC Power frequency (50/60 Hz) Magnetic field IEC IEC Test Level ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/ output lines ± 1 kv line to line ± 2 kv line to earth < 5% UT (> 95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 seconds Compliance Level ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/ output lines ± 1 kv line to line ± 2 kv line to earth < 5% UT (> 95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (> 95% dip in UT) for 5 seconds Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Flexitouch System requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. During treatment, LCD screen operation is NOT required for essential performance or basic safety and degradation of its operation does NOT result in an unacceptable risk. 45 Customer Service Toll-Free:

48 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 Test Conducted RF IEC IEC Test Level 3 Vrms 150 khz to 80 MHz Compliance Level [V1] 3 Vrms Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Flexitouch System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Radiated RF IEC V/m 80 MHz to 2,5 GHz [E1] 3 V/m d = [ 3,5/V1 ] P d = [ 3,5/E1 ] P 80 MHz to 800 MHz d = [ 7/E1 ] P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Flexitouch System is used exceeds the applicable RF compliance level above, the Flexitouch System should be observed to verify normal operation. If abnormal performance is observed additional measures may be necessary, such as re-orienting or relocating the Flexitouch System. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than [V1] V/m. 46

49 DEVICE LABEL The device label is found on the back of your device. To read the label, place the device facing away from you at eye level at a distance that maximizes character clarity generally 20 inches (50 cm) to 40 inches (100 cm) with an illumination of 500 lx minimum. Call Tactile Medical Customer Service if label reading issues remain. NOTES: Device label not to scale. Device label depiction may be different than that on your device. See pages 1 and 2 for symbol definitions. 47 Customer Service Toll-Free: