Advanced Pneumatic Compression
Flexitouch® System
U S E R
MODEL PD32-U
G U I D E
Table of Contents
Chapter 1
Before You Get Started. . . . . . . . . . . . . . 1
1.1 How to Contact
Tactile Medical . . . . . . . . . . . . . . . . . . . 1
1.2 Safety Precautions and
Explanation of Symbols. . . . . . . . . . . 1
1.3 Indications for Use. . . . . . . . . . . . . . . . 3
1.4Contraindications . . . . . . . . . . . . . . . . 4
1.5 Unpacking Instructions. . . . . . . . . . . 5
Chapter 2
The Flexitouch® System . . . . . . . . . . . . . 7
2.1 System Components . . . . . . . . . . . . . 7
2.2 Programmed Pressure Levels . . . . . 8
2.3 Treating the Lower
Extremity . . . . . . . . . . . . . . . . . . . . . . . . 9
2.4 Treating the Upper
Extremity . . . . . . . . . . . . . . . . . . . . . . . 12
2.5 Treating the Head and Neck . . . . . 14
Chapter 3
Controller Set-Up. . . . . . . . . . . . . . . . . . 15
3.1 Setting Up the Controller
Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2 Select Your Settings . . . . . . . . . . . . . 16
Chapter 4
Garment and Accessory
Application–Lower Extremity . . . . . . 18
4.1 Applying the Full Leg
Garment. . . . . . . . . . . . . . . . . . . . . . . . 18
4.2 Applying the Full Leg
Garment and
Trunk Accessory. . . . . . . . . . . . . . . . . 20
4.3 Applying the Calf-Foot
Garment and
Trunk-Thigh Accessory. . . . . . . . . . . 22
Chapter 5
Garment and Accessory
Application–Upper Extremity . . . . . . 24
5.1 Applying the Arm Garment. . . . . . 24
5.2 Applying the Trunk Accessory
and Arm-Shoulder Garment . . . . . 25
Chapter 6
Garment Application–
Head and Neck . . . . . . . . . . . . . . . . . . . . 30
6.1 Applying the Head Garment
and the Vest for Head and Neck . . 30
Chapter 7
Connecting the Hoses to
the Controller . . . . . . . . . . . . . . . . . . . . . 34
Chapter 8
Conducting a Therapy Session. . . . . . 37
8.1 Starting the Therapy Session. . . . . 37
8.2 Pausing the Therapy Session. . . . . 37
8.3 Completing the Therapy Session. . 38
8.4 Turning the Controller Unit Off. . . 38
8.5 Storing the Flexitouch System . . . 38
8.6 Cleaning the Flexitouch
System. . . . . . . . . . . . . . . . . . . . . . . . . . 38
Chapter 9
Troubleshooting and
Specifications . . . . . . . . . . . . . . . . . . . . . 40
9.1Troubleshooting. . . . . . . . . . . . . . . . 40
9.2 Limited Warranty and
Service for Home Use. . . . . . . . . . . . 42
9.3 Limited Warranty and
Service for Facility Use. . . . . . . . . . . 42
9.4 Equipment Lifetime . . . . . . . . . . . . . 42
9.5 Return Policy. . . . . . . . . . . . . . . . . . . . 42
9.6Patents. . . . . . . . . . . . . . . . . . . . . . . . . . 43
9.7 Technical Information . . . . . . . . . . . 43
For Additional Questions . . . . . . . . . . . 48
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: 612.355.5100 or toll-free (U.S. only) at 866.435.3948,
Monday through Friday, 7:00am – 7:00pm CT. You may also email us at
[email protected].
If you have medical questions, please contact your physician or healthcare provider.
1.2 Safety Precautions and Explanation of Symbols
I MPORTANT: 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: 866.435.3948
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 612.355.5100 or toll-free at
866.435.3948 (U.S. only) to get disposal instructions.
Type BF Applied Part
Device Serial Number
L Certification Mark
U
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 UL60601-1
E Mark Certification
C
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) 70 345 8570 Fax: (+31) 70 346 7299
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
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.
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Customer Service Toll-Free: 866.435.3948
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
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)
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Customer Service Toll-Free: 866.435.3948
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
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.
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Customer Service Toll-Free: 866.435.3948
Table 1: Treatment Programs and Therapy Times
Program
Program Display
Body Regions Treated
Single Cycle Available
Time (min.) Cycles
U1
Full arm & core
Trunk, chest, biceps,
forearm and hand
60
1
U4
Arm-shoulder
Biceps, forearm
and hand
47
1–5
U7
Full arm
Arm
30
1–5
U2
Trunk ONLY-UPPER
Trunk
12
1–5
U3
Trunk & chest
Trunk and chest
24
1–5
U5
Forearm & hand
Forearm and hand
24
1–5
U6
Hand only
Hand
12
1–5
H1
Head neck & vest
H2
Head only
L1
Full leg & core
Trunk, thigh, calf
and foot
60
1
L4
Full leg plus
Thigh, calf and foot
45
1–5
L5
Half leg plus
Calf and foot
30
1–5
L7
Half leg
Calf and foot
30
1–5
L8
Full leg
Thigh, calf and foot
45
1–5
Upper Extremity
Primary Upper Extremity Treatment Programs
Supplemental Upper Extremity Treatment Programs
Primary Head and Neck Treatment Program
Head, neck & chest
32
1
Supplemental Head and Neck Treatment Program
Head, neck
15
1
Lower Extremity
Primary Lower Extremity Treatment Programs
Supplemental Lower Extremity Treatment Programs
L2
Trunk ONLY-LOWER
Trunk
15
1–5
L3
Trunk & thigh
Trunk and thigh
30
1–5
L6
Foot only
Foot
15
1–5
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
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
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Customer Service Toll-Free: 866.435.3948
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. Trunk
directs fluid from
top of the thigh
to waist
1
2. Thigh
directs fluid from
knee to top of
the thigh
2
3. Calf
directs fluid
from ankle to
knee
3
4
5
4. Foot
directs fluid
from toes to
ankle
10
5. Full Leg
to Trunk
directs fluid from
toes to top of waist
in one continuous
motion
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)
1. Thigh
directs fluid
from knee to top
of thigh
1
4. Full Leg
directs fluid from
toes to top of thigh
in one continuous
motion
2. Calf
directs fluid from
ankle to knee
2
3
3. Foot
directs fluid from
toes to ankle
4
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Customer Service Toll-Free: 866.435.3948
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
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
3. Biceps
directs fluid
from elbow
toward
shoulder
3
2
4. Forearm
directs fluid
from wrist
toward elbow
4
5
6. Full Arm
and Trunk
directs fluid
from fingers
to the top of
thigh in one
continuous
motion
6
5. Hand
directs fluid from
fingers toward wrist
1
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Customer Service Toll-Free: 866.435.3948
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)
3
2
1
3. 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
14
4. Full Head,
Neck and Chest
directs fluid from
head to the under
arm area in one
continuous motion
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 4.
3.1 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
NOTE: The power cord required for your
country may be different than shown.
Three-pronged Plug
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.
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Customer Service Toll-Free: 866.435.3948
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
Figure 3b. Controller Unit Front Panel
Program
Time
Remaining
Garment
Pressure
Therapy Cycles
On/Off
Start/Pause
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.
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Customer Service Toll-Free: 866.435.3948
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
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
5
4
3
6
2
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Customer Service Toll-Free: 866.435.3948
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
9
8
7
5
WAIST EXTENDER
20
6
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
11
10
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Customer Service Toll-Free: 866.435.3948
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
7.If necessary, readjust the fasteners
to obtain a well-contoured and
comfortable fit.
5
2
6
WAIST EXTENDER
22
4
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
9
11
10
12
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Customer Service Toll-Free: 866.435.3948
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
I f 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
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
4
2
1
Figure 5.1.c.
Fully Applied
Arm Garment
5
3
5.2 A
pplying 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.
T he 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.
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Customer Service Toll-Free: 866.435.3948
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
2
WAIST EXTENDER
4
26
The trunk
section must
fit close to
the groin area.
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.
7
10
6
8
9
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Customer Service Toll-Free: 866.435.3948
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
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
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Customer Service Toll-Free: 866.435.3948
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 30–40 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 A
pplying 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
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.c.
Adjust Right Inner Flap Under Chin
Figure 6.1.b.
Conform Nose Piece Across the
Bridge of the Nose
Figure 6.1.d.
Attach Hook Fasteners of Left Outer Chin Flap
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Customer Service Toll-Free: 866.435.3948
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
7
9
10
10. 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
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
12
13.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.
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Customer Service Toll-Free: 866.435.3948
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
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.)
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Customer Service Toll-Free: 866.435.3948
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
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.
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Customer Service Toll-Free: 866.435.3948
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
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 dry clean.
• Do not iron.
• Do not machine wash.
• Do not machine dry.
• Do not disassemble.
• Do not autoclave.
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 1910.1030) 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: 866.435.3948
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 866.435.3948 (U.S. only) or 612.355.5100.
9.1 Troubleshooting
Table 3: Troubleshooting
Issue
Recommended Solution
Controller does not
function or display
does not illuminate
1. D
isconnect 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
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.
The chambers do
not fill with air
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.
Hook fasteners do
not stay closed
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
Table 3: Troubleshooting (continued)
Issue
Recommended Solution
Chambers are
not filling in the
expected pattern
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 1. Verify that the correct program and garment size have been selected.
are higher or lower 2. Adjust the fit of the garment, ensuring no folds or kinks are in the fabric.
than expected
3. Check to be sure the latches are firmly in place and attached to the
correctly numbered port.
Chambers remain
inflated
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.
Controller runs
longer than
expected
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 have
broken or become
disconnected
from garment
connectors
Latches can be replaced or reattached. Please call Customer Service for
instructions.
There is no short
petite garment size
selection on my
controller
The short petite full leg garment utilizes the short full leg garment size setting
on the controller.
The controller
makes an abnormal
noise
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.
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Customer Service Toll-Free: 866.435.3948
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
9.6 Patents
The Flexitouch System is protected by the following United States patents:*
6,179,7966,645,165
6,860,8626,966,884
*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:
Table 4: Flexitouch System – Technical Information
Model Number
PD32–U
Input Voltage/Frequency
100–240 VAC 50/60 Hz
Current
1.0 A Maximum
Fuse Rating
T 1AH, 250V (Only replace fuses with 1 Amp high breaking
capacity,
time lag 250V minimum fuses)
Controller Size
5.5” x 12.3” x 10.5” (140 mm x 312 mm x 267 mm)
Controller Weight
8 lbs. (3.5 kgs)
Outer Fabric
100% nylon, not made with natural rubber latex
Therapy Programs
15
Chambers (max)
32
Mode of Operation
Continuous
Calibration
Recalibration not required for the Flexitouch System
Electromagnetic Interference (EMI)
Electromagnetic Compatibility (EMC)
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 8.
Operating Atmospheric Pressure
700 to 1060 hPa
Device Transport and
Storage Temperature Limits
Device Operating
Temperature Limits
43
Device Operating
Humidity Limits
Customer Service Toll-Free: 866.435.3948
Table 5: Flexitouch System – Classification Information
US FDA Medical Device
Class II per 21CFR 870.5800 & 21 CFR 890.5650
Canada Medical Device
Class II per Canadian Medical Devices Regulations
SOR/98-282
European Union Medical Device
Class IIa per Medical Devices Directive 93/42/EEC
Protection Against Electric Shock
Hazard
Class I per UL/EN/IEC 60601-1
Protection Against Fluid Ingress
IP21
Applied Part
BF
Table 6: Flexitouch System – Conformance Information
Quality Assurance
FDA 21 CFR 820 QSR
ISO 13485
Safety
UL/EN/IEC 60601-1
CAN/CSA C22.2 No. 601.1
Electromagnetic Compatibility (EMC)
EN 60601-1-2
Waste Electrical & Electronic
Equipment (WEEE)
Directive 2002/96/EC
Restriction of Hazardous Substances
(RoHS)
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
Group 1
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.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not
applicable
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.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
44
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
IEC 60601 Test
Level
Compliance Level
Electromagnetic
Environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line to line
± 2 kV line to earth
± 1 kV line to line
± 2 kV line to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power
supply lines
IEC 61000-4-11
< 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
< 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
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.
Power frequency
(50/60 Hz)
Magnetic field
IEC 61000-4-8
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: 866.435.3948
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
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
[V1] 3 Vrms
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 61000-4-3
3 V/m
80 MHz to 2,5 GHz
d = [ 3,5/V1 ] P
[E1] 3 V/m
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.
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.
a
46
47
Customer Service Toll-Free: 866.435.3948
DEVICE LABEL
•See pages 1 and 2 for symbol definitions.
•Device label depiction may be different than that on your device.
• Device label not to scale.
NOTES:
•Call Tactile Medical Customer Service if label reading issues remain.
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.
For Additional Questions
If you have any questions that are not covered by this user guide, contact:
Tactile Medical
1331 Tyler Street NE, Suite 200
Minneapolis, MN 55413
Telephone: 612.355.5100
Toll-free Telephone: 866.435.3948 (U.S. only)
Fax: 612.355.5101
Toll-free Fax: 866.435.3949 (U.S. only)
Hours of Operation: Monday–Friday 7 a.m. to 7 p.m. CT
Email: [email protected]
www.tactilemedical.com
EU Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
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49
Customer Service Toll-Free: 866.435.3948
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
1331 Tyler Street NE, Suite 200
Minneapolis, MN 55413 USA
T: 612.355.5100
F: 612.355.5101
Customer Service:
Toll-Free Tel: 866.435.3948
Toll-Free Fax: 866.435.3949
Hours: Monday through Friday, 7 a.m. – 7 p.m. CT
www.tactilemedical.com
Flexitouch and the Flexitouch logo are registered trademarks of Tactile Systems
Technology Inc., DBA Tactile Medical. Velcro® is a registered trademark of Velcro
Industries B.V. DisCide® is a registered trademark of Palmero Health Care Corporation.
©2016 Tactile Systems Technology Inc., DBA Tactile Medical. All rights reserved.
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.
D/N: 500020-002-00 Rev. C 12/2016