Flexitouch® System User`s Guide

Transcription

Flexitouch® System User’s Guide
Model PD32-U
Table of Contents
Chapter 1:
Chapter 5:
Before You Get Started.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
How to Contact Tactile Medical. . . . . . . . . . . . . . . . .
Safety Precautions and
Explanation of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unpacking Instructions.. . . . . . . . . . . . . . . . . . . . . . . . . . .
2
2
2
5
5
5
Chapter 2:
The Flexitouch® System.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
System Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Controller. ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Garments and Accessories. . . . . . . . . . . . . . . . . . . . 7
Programmed Pressure Levels. . . . . . . . . . . . . . . . . . . . 8
Treating the Lower Extremity. . . . . . . . . . . . . . . . . . . . 9
Full Leg Treatment.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Full Leg and Core Treatment.. . . . . . . . . . . . . . . 10
Full Leg Plus Treatment. . . . . . . . . . . . . . . . . . . . . . 11
Treating the Upper Extremity.. . . . . . . . . . . . . . . . . 12
Full Arm Treatment.. . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Full Arm and Core Treatment. . . . . . . . . . . . . . . 13
Chapter 3:
Controller Set-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Setting Up the Controller Unit.. . . . . . . . . . . . . . . . 14
Select Your Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Chapter 4:
Garment and Accessory Application–
Lower Extremity.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Applying the FULL LEG Garment.. . . . . . .
4.2 Applying the FULL LEG Garment
and TRUNK Accessory.. . . . . . . . . . . . . . . . . . . . .
4.3 Applying the CALF-FOOT Garment
and TRUNK-THIGH Accessory. . . . . . . . . . . .
17
18
19
Garment and Accessory Application–
Upper Extremity..................................... 23
5.1 Applying the ARM Garment.............. 24
5.2 Applying the TRUNK and CHEST
Accessories and the ARM Garment..... 25
Chapter 6:
Connecting the Hoses to
the Controller......................................... 30
Chapter 7:
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.. .............
Cleaning the Controller Unit. . ..............
33
33
33
33
33
34
34
34
Cleaning the Garments and
Accessories...................................... 34
Disinfecting the Flexitouch System....... 34
Chapter 8:
Troubleshooting and Specifications. . .........
Troubleshooting.. .................................
Limited Warranty and Service
for Home Use. . .....................................
Limited Warranty and Service
for Facility Use.. ....................................
Equipment Lifetime..............................
Patents...............................................
Technical Information. . ..........................
For Additional Questions.......................
35
35
37
37
37
37
38
43
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Customer Service Toll-Free: 866.435.3948
1
CHAPTER
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.
HOW TO CONTACT TACTILE MEDICAL
If you have questions about the Flexitouch system operation, or if your Flexitouch system requires
service, contact Tactile Medical.
Customer Service is available at 612.355.5100 or toll-free at 866.435.3948 (U.S. only). You may also
email us at [email protected].
If you have medical questions, please contact your physician or healthcare provider.
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.
2
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
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 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.
3
Chapter 1 Before You Get Started
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.
• D
o not disassemble the controller.
• U
se of outlets and power cords that have a ground connection reduces the risk of
electric shock.
• Y
our 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.
• U
nplug the controller when not in use.
• The Flexitouch system is to be used indoors only.
• D
o not use the controller near water or while bathing.
• D
o not reach for the controller if it falls into water. Unplug the controller at the electrical
outlet immediately.
WARNING: Risk of Personal Injury
• U
se the controller only for its intended purpose, as directed in this guide.
• U
se accessories only if recommended or supplied by Tactile Medical.
• S etup the controller in a manner that provides easy access to the power cord should it
become necessary to unplug quickly.
• N
ever 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.
• N
ever operate the controller where the cord or tubing harness will present a strangulation
or tripping hazard.
• S trangulation potential: Power cord and tubing bundle should never be placed near or
around a person’s neck.
CAUTION: Risk of Device Damage
• N
ever 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.
• N
ever drop or insert any object into any opening of the controller.
• N
ever 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.
4
INDICATIONS FOR USE
The Flexitouch system is 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 insufficiencies
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
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.
UNPACKING INSTRUCTIONS
When your Flexitouch system arrives at your home, 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’s Guide
• Power cord (10' maximum)
• Controller unit
• Training DVD
• Garments and accessories needed to treat your condition
• 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.
5
Chapter 1 Before You Get Started
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)
Upper Extremity Treatment
The garments and accessories needed for upper extremity treatment may include the following:
• ARM garment (available in SHORT or LONG)
• CHEST accessory (available in sizes 1 thru 4)
• TRUNK accessory
• WAIST EXTENDER(S)
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 and arm).
See Figure 1a.
Figure 1a. Label Examples
6
2
CHAPTER
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.
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 the arm and core.
Depending on your clinical needs, you may be prescribed an ARM garment, or CHEST and TRUNK
accessories and ARM garment.
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
Chapter 2 The Flexitouch® System
Table 1: Treatment Programs and Therapy Times
Program
Program Display
Body Regions Treated
Single Cycle
Time (minutes)
Available
Cycles
Upper Extremity
Primary Upper Extremity Treatment Programs
U1
FULL ARM & CORE
Trunk, chest, bicep, forearm
and hand
60
1
U7
FULL ARM
Arm
30
1–5
Supplemental Upper Extremity Treatment Programs
U2
TRUNK ONLY-UPPER
Trunk
12
1–5
U3
TRUNK & CHEST
Trunk and chest
24
1–5
U4
ARM
Bicep, forearm and hand
36
1–5
U5
FOREARM & HAND
Forearm and hand
24
1–5
U6
HAND ONLY
Hand
12
1–5
Lower Extremity
Primary Lower Extremity Treatment Programs
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
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
PROGRAMMED PRESSURE LEVELS
Programmed pressure levels in each of the air chambers are based on physiological principles of
how lymph fluid moves through the 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
Figure 2a. Treating the Lower Extremity
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
Figure 2b. Treating the Lower Extremity
FULL LEG AND CORE
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.
1. TRUNK
directs fluid from top
of the thigh to waist
1
2. THIGH
directs fluid from
knee to top of the
thigh
2
5. FULL LEG
TO TRUNK
directs fluid from toes
to top of waist in one
continuous motion
3. CALF
directs fluid from
ankle to knee
3
4. FOOT
directs fluid from
toes to ankle
4
5
10
Figure 2c. Treating the Lower Extremity
FULL LEG PLUS
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.
1. THIGH
directs fluid
from knee to top
of thigh
1
2. CALF
directs fluid from
ankle to knee
2
3
11
4
3. FOOT
directs fluid from
toes to ankle
4. FULL LEG
directs fluid from
toes to top of thigh
in one continuous
motion
Figure 2d. Treating the Upper Extremity
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.
ARM
begins at fingertips and
ends at top of bicep in
one continuous motion
12
Figure 2e. Treating the Upper Extremity
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.
3. BICEP
directs fluid from elbow
toward shoulder
2. CHEST
directs fluid
from shoulder
toward waist
1. TRUNK
directs fluid
from waist
toward top
of thigh
2
1
4. FOREARM
directs fluid from
wrist toward elbow
3
4
5. HAND
directs fluid from
fingers toward wrist
5
6
13
6. FULL ARM
AND TRUNK
directs fluid
from fingers
to the top of
thigh in one
continuous
motion
3
CHAPTER
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.
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.)
NOTE: Do not plug the Flexitouch system into a power strip.
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 hospital-grade
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.
14
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. S elect 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. S elect 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. S elect 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.
15
Chapter 3 Controller Set-up
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
LONG FULL LEG
SHORT ARM
MEDIUM FULL LEG
LONG ARM
SHORT FULL LEG
SZ 1 CHEST/SHORT ARM
TRUNK/SHORT FULL LEG
SZ 1 CHEST/LONG ARM
TRUNK/MED FULL LEG
TRUNK/LONG FULL LEG
SZ 2 CHEST/LONG ARM
SHORT TRUNK/REG CALF
SHORT TRUNK/EXT CALF
SZ 3 CHEST/LONG ARM
LONG TRUNK/REG CALF
LONG TRUNK/EXT CALF
SZ 4 CHEST/LONG ARM
EXT TRUNK/REG CALF
SZ 4 CHEST/LONG ARM
EXT TRUNK/EXT CALF
* NOTE: The short petite FULL LEG garment utilizes the SHORT FULL LEG garment size setting on
the controller.
16
4
CHAPTER
Garment and Accessory Application—
Lower 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
Wear lightweight, loose-fitting (non-elastic) cotton clothing to avoid skin irritation that may result
from contact with the nylon material. 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
17
Chapter 4 Garment and Accessory Application—Lower Extremity
4.1
Full Leg
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.
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 6 for further instructions.
Figure 4.1.a. Applying the FULL LEG Garment
5
4
3
6
2
18
4.2
Full Leg and Trunk
I f 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. 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.
9
8
7
5
WAIST EXTENDER
19
6
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.
Figure 4.2.b. Fully Applied FULL LEG Garment and TRUNK Accessory
11
10
20
4.3
Calf-Foot and Trunk-Thigh
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.
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, 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.
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.
Figure 4.3.a. Applying the CALF-FOOT Garment
7
5
2
6
WAIST EXTENDER
21
4
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.
Figure 4.3.b. Fully Applied EXT Lower Extremity Garment Set
9
12
11
10
22
5
CHAPTER
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
Wear lightweight, loose-fitting (non-elastic) cotton clothing to avoid skin irritation that may result
from contact with the nylon material. 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
23
Chapter 5 Garment and Accessory Application—Upper Extremity
5.1
Arm
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.
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 bicep 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.
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
24
5.2
Trunk, Chest and Arm
If you have received garments and accessories labeled TRUNK, CHEST and ARM,
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, CHEST second and ARM last.
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.
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
25
4
The trunk
section must
fit close to
the groin area.
CHEST ACCESSORY PREPARATION:
Before applying the CHEST accessory, disengage the hook fastener strap on the front of the
CHEST accessory.
6. Open the front of the CHEST accessory by gently pulling on the front hook fastener strap.
7. Open the strap wide enough so you will be able to slide your unaffected arm through the opening.
8. Loosen the hook fasteners around the bicep section to allow your affected arm (the arm being
treated) to easily slide through.
CHEST ACCESSORY APPLICATION:
9. Slide your unaffected arm through the opening like a vest.
10. Then slide your affected arm through the bicep portion of the accessory, pulling up on the
shoulder area so it is close to the neck and lies flat along the top of the shoulder.
11. Ensure that the front of the CHEST accessory crosses the center line of your chest when attached.
Secure the hook fasteners.
12. Make sure the curve of the front strap aligns with the curve of the CHEST accessory.
Figure 5.2.c. Applying
the CHEST Accessory
Figure 5.2.b. Preparing the
CHEST Accessory
6
8
10
9
7
11
12
26
13. Readjust and tighten the hook fasteners on the bicep, under the arm, and on the chest fabric to
obtain a well-contoured fit.
NOTE: If needed, a chest enclosure strap can be used to cinch gaps occurring anywhere on the
accessory. A common area where this is used is near the neck on the shoulder.
Figure 5.2.d. Arrows Indicating Accessory
Adjustment Points
Figure 5.2.e. Fully Applied CHEST
and TRUNK Accessories
13
27
ARM GARMENT PREPARATION:
14. 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.
15. Next, fold the four hook fastener tabs on the top of the ARM garment back so they are secured to
the ARM garment itself.
ARM GARMENT APPLICATION:
16. Slide your arm into the pre-shaped cone, making sure the tabs run along the inside of your arm
toward your torso.
17. Pull the ARM garment up toward your bicep making sure that your fingertips remain fully
enclosed in the garment.
18. Attach the four hook fastener tabs at the top of the ARM garment to the CHEST accessory.
19. Readjust the tabs along the side 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.
Figure 5.2.f.
Preparing the
ARM Garment
Figure 5.2.g.
Adjusting the ARM Garment
for a Snug Fit
Figure 5.2.h.
Fully Applied
ARM Garment
18
17
16
15
19
14
28
FULLY APPLIED TRUNK AND CHEST ACCESSORIES AND ARM GARMENT
20. Properly applied, the garment and accessories will follow the contours of your body and fit
snugly yet comfortably. To ensure they fit well, you may need to readjust the CHEST accessory
after you lie down. Make sure the accessory fits tightly against your shoulder.
21. 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.
Figure 5.2.i. Fully Applied TRUNK and CHEST Accessories and ARM Garment
20
21
29
6
CHAPTER
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 you received FULL LEG only or FULL ARM only.
Do not remove, as your prescribed therapy does not use this port(s).
Figure 6a. 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 6b.)
Figure 6b. Corresponding Hose Connector with Controller Connector
Numbered Controller Connector
Controller Notch
Numbered Connector
30
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 6c.)
Figure 6c. 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 6d.)
Figure 6d. Properly Connecting the Latches
6. Repeat for all connectors required for your prescribed treatment. (Figure 6e, 6f and 6g on next page.)
31
Chapter 6 Connecting the Hoses to the Controller
Figure 6e. Fully attached Hose Connectors when Full Leg Treatment is prescribed
Figure 6f. Fully attached Hose Connectors when Full Arm Treatment is prescribed
Figure 6g. 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.
32
7
CHAPTER
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.
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.
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.
COMPLETING THE THERAPY SESSION
The therapy program will stop automatically when the treatment has been completed and TIME
REMAINING will display DONE.
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.
33
Chapter 7 Conducting a Therapy Session
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.
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.
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 disassemble.
• Do not machine dry.
• Do not autoclave.
Disinfecting the Flexitouch System
For device use in multi-patient situations, it is important to minimize cross-contamination by
disinfecting the Flexitouch system between patients’ usage. To disinfect the Flexitouch system use
STERI-FAB® or an equivalent disinfectant. Use as instructed by the disinfectant manufacturer.
34
8
CHAPTER
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.
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
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 tooth
brush, 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.
35
Chapter 8 Troubleshooting and Specifications
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
1. Verify that the correct program and garment size have been selected.
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:
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.
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. V
erify 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. I f 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.
CustomerService
ServiceToll
Toll-Free:
866.435.3948
Customer
Free: 866.435.3948
36
LIMITED WARRANTY FOR HOME USE
Tactile Medical (TM) 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. TM’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 TM, be repaired. Replacement parts
may be new or refurbished parts as solely determined by TM. 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
TM for any purpose, nor give rise to any liability or obligation of TM. EXCEPT FOR THE FOREGOING,
TM 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
TM FOR DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE USE, REPAIR OR PERFORMANCE OF
THE FLEXITOUCH SYSTEM. IN NO EVENT SHALL TM 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 TM 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.
LIMITED WARRANTY AND SERVICE FOR FACILITY USE
Contact Tactile Medical for information regarding the service agreements available to facilities.
EQUIPMENT LIFETIME
The expected equipment lifetime is equal to the warranty period.
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.
37
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, latex free
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
Device Operating
Humidity Limits
38
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.
39
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
Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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.
40
Table 8: Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity (continued)
The customer or the user of the Flexitouch should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Conducted RF
IEC 61000-4-6
Compliance Level Electromagnetic Environment – Guidance
3 Vrms
[V1] 3 Vrms
150 kHz to 80 MHz
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:
d = [ 3,5/V1 ] P
Radiated RF
IEC 61000-4-3
3 V/m
[E1] 3 V/m
80 MHz to 2,5 GHz
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
41
42
•See pages 2 and 3 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.
DEVICE LABEL
FOR ADDITIONAL QUESTIONS
If you have any questions that are not covered by this user’s 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 8 a.m. to 5 p.m. CT
Email: [email protected]
www.tactilemedical.com
EU AUTHORIZED REPRESENTATIVE
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: (+31) 70 345 8570
Fax: (+31) 70 346 7299
©2013 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.
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.
STERI-FAB® is a registered trademark of Castoleum Corporation.
43
44
Tactile Medical
1331 Tyler Street NE, Suite 200
Minneapolis, MN 55413 USA
T: 612.355.5100
F: 612.355.5101
Toll-Free Tel: 866.435.3948
Toll-Free Fax: 866.435.3949
Hours: Monday through Friday, 8 a.m. – 5 p.m. CT
www.tactilemedical.com
©2013 Tactile Systems Technology Inc., DBA Tactile Medical. All rights reserved. D/N: 500020-000-00 Rev.G 11/2013

Flexitouch® System User`s Guide

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