Tactile Medical Entre Plus User manual

Entre®Plus User Guide
Model PD08-NG
ENTRE®PLUS
PNEUMATIC COMPRESSION SYSTEM

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 ............2
1.3 Indications for Use ........................................4
1.4 Contraindications .........................................5
1.5 Unpacking Instructions....................................5
1.6 Labels ....................................................6
Chapter 2 The Entre Plus System .........................7
2.1 System Components ......................................7
2.2 Adjustable Pressure Levels ................................8
2.3 Treating the Lower Extremity..............................9
2.4 Treating the Upper Extremity.............................10
Chapter 3 Controller Unit Set-Up ........................11
3.1 Setting Up the Controller Unit ............................11
3.2 Connecting the Hose to the Controller Unit ...............12
Chapter 4 Garment Application..........................15
4.1 Applying the Full Leg and Half Leg Garment ..............16
4.2 Applying the Arm Garment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Chapter 5 Conducting a Treatment Session............19
5.1 Selecting Your Pressure Setting ...........................19
5.2 Starting the Treatment Session ...........................20
5.3 Pausing the Treatment Session ...........................21
5.4 Completing the Treatment Session .......................21
5.5 Storing the Entre Plus System.............................21
5.6 Cleaning the Entre Plus System ...........................22
5.7 Disinfecting the Entre Plus System ........................23

Chapter 6 Troubleshooting and Specifications ...... 24
Chapter 7 Warranty ....................................... 28
7.1 Limited Warranty and Service for Home Use ...............28
7.2 Limited Warranty and Service for Facility Use ..............29
7.3 Return Policy ............................................29
7.4 Equipment Lifetime ......................................29
Chapter 8 Technical Information ....................... 30
8.1 Technical Information ....................................30
8.2 Device Labels............................................34
For Additional Questions........................ Back Cover

1
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 Entre Plus system is a pneumatic compression device designed
for at-home treatment of lymphedema, chronic edema, venous
insuciency and chronic wounds. When used daily, pneumatic
compression 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
Entre Plus system.
1.1 How to Contact Tactile Medical
If you have questions about the Entre Plus system or require service,
contact Tactile Medical:
By phone: Customer Service: toll free at 833.3TACTILE (833.382.2845),
7 a.m. to 7 p.m. CT, Monday–Friday.
By email: [e-mail].
If you have medical questions, please contact your physician or
healthcare provider.

2Customer Service Toll Free: 833.3TACTILE (833.382.2845)
IMPORTANT: Read Instructions Before Using
Before attempting to connect or operate this product, please read the
entire guide. Keep this guide available for future reference.
CAUTION
Manufacturer’s Model ID
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 treatment program, treatment
cycles, and/or duration of treatment. Use this product only at the
settings prescribed by your healthcare provider.
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
toll free at 833.3TACTILE (833.382.2845) to get disposal instructions.
Type BF Applied Part
Device Serial Number
Intertek Mark
Product Category: Medical Equipment
Product Category CCN: PIDF
Class II with respect to electrical shock, re and mechanical hazards
only in accordance with EN60601-1
IP21 The Entre Plus system complies with IEC60329 regarding the
degree of protection against water and particulates.
1.2 Safety Precautions and Explanation of Symbols

3
EMC Precautions
The Entre Plus system is Medical Electrical Equipment that has been tested
and demonstrated to be compatible with electromagnetic compatibility (EMC)
CISPR 11 Class B limits and is therefore suitable for use in hospital, clinic and
home care environments.
WARNING: The Entre Plus provides a sequential ination and deation of the
garment chambers in a dened sequences. An EM disturbance may cause the
controller to stop functioning. Use of this equipment adjacent to or stacked
with other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
WARNING: Power cords can be aected by EMC. Use only the power cord
provided by Tactile Medical. Unauthorized power adapters could result in
increased electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the Entre Plus system.
WARNING: Risk of Electric Shock
Do not attempt to service the controller unit. Such attempts could result in
injury or damage to the product, and will void any warranty.
Do not disassemble the controller unit.
Unplug the controller unit when not in use.
The Entre Plus system is to be used indoors only.
Do not use the controller unit near water or while bathing.
Do not reach for the controller unit if it falls into water. Unplug the controller
unit at the electrical outlet immediately.
WARNING: Risk of Personal Injury
Use the controller unit only for its intended purpose, as directed in this guide.
Use only the power adapter provided with your Entre Plus system.
Use only accessories approved by Tactile Medical. Other accessories may
damage the system or interfere with system function.
Setup the controller unit in a manner that provides easy access to the power
adapter should it become necessary to unplug quickly.
Never operate the controller unit if the power adapter or plug is not working
properly, if it has been damaged, or if the controller unit has been dropped
into water. Return it to Tactile Medical for inspection and/or replacement.
Do not modify the power adapter or plug.

4Customer Service Toll Free: 833.3TACTILE (833.382.2845)
WARNING: Risk of Personal Injury, continued
Keep the power adapter away from heated surfaces.
Never operate the controller unit where the power adapter or tubing harness
will present strangulation or tripping hazard.
Strangulation potential: Power adapter and tubing bundle should never be
placed near or around a person’s neck.
Do not use the Entre Plus system in the presence of ammable gasses,
including ammable anesthetics.
CAUTION: Risk of Device Damage
Never block the ventilation openings on the sides of the controller
unit. Keep the ventilation openings free of debris such as lint and hair.
Never operate the controller unit 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 unit.
Never use sharp objects, such as pins, scissors or clasps on or near
the Flexitouch Plus system.
Never use hot devices such as irons or blow dryers on or near the
Flexitouch Plus system.
Keep the product free from debris to avoid valve closed or valve
opened failures.
Never place the product in a position or location that would allow
the tubing harness to become pinched.
1.3 Indications For Use
The Entre Plus system is intended for use by medical professionals
and patients who are under medical supervision, for the treatment of
the following conditions:
Chronic edema
Lymphedema
Venous insuciency
Chronic wounds

5
1.4 Contraindications
The Entre Plus system should not be used if you have one or more of
the following conditions:
Heart failure (acute pulmonary edema, decompensated acute
heart failure)
Acute venous disease (acute thrombophlebitis, acute deep venous
thrombosis, acute pulmonary embolism)
Severe peripheral artery disease (critical limb ischemia including
ischemic rest pain, arterial wounds or gangrene)
Active skin or limb infection/inammatory disease (acute cellulitis,
other uncontrolled skin or untreated inammatory skin disease)
Active cancer (cancer that is currently under treatment, but not yet
in remission)
Any circumstance where increased lymphatic or venous return is
undesirable
1.5 Unpacking Instructions
When your Entre Plus system arrives, it is important that you carefully
unpack the contents and ensure that you have all the equipment
required to begin operation. If the Entre Plus system is exposed to
storage temperature extremes, allow the system to stabilize at room
temperature for at least 6 hours before use.
Included in the box, you should nd the following:
Controller unit Power adapter
Garment(s) and accessory(ies) Quick Start Guide
to treat your condition
The garment(s) and accessory(ies) you receive will depend upon your
individual treatment requirements. If you are missing any of the items
listed for your prescribed treatment, please contact Customer Service
toll free at 833.3TACTILE (833.382.2845).

6Customer Service Toll Free: 833.3TACTILE (833.382.2845)
Lower Extremity Treatment
The garments and device accessory(ies) needed for lower extremity
treatment may include the following:
Full leg garment
Half leg garment
Extender (provided only if ordered)
Port cover for unilateral treatment
Upper Extremity Treatment
The garments and device accessory needed for upper extremity
treatment may include the following:
Arm garment
Port cover for unilateral treatment
1.6 Labels
The 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, half leg and arm) (Figure 1.6.a.).
Figure 1.6.a. Label Examples

7
CHAPTER 2
The Entre Plus System
The Entre Plus system is a pneumatic compression device that
delivers intermittent sequential compression treatment to the
aected extremities of patients with lymphedema, chronic edema,
venous insuciency, and chronic wounds.
NOTE: No special skills, training or knowledge is required to operate the
Entre Plus system.
2.1 System Components
The Entre Plus system consists of two primary components:
Controller Unit
The controller unit delivers compressed air via a hose connector
which is attached to the garment. Depending on the prescription
from your physician, an additional garment can be added to allow
simultaneous bilateral treatment. The device applies dierent levels
of pressure along the length of your limb. For example, your toes
or ngers will receive more pressure; your thigh or upper arm will
receive less.
Garments and Port Cover
The air-chambered garments are made of soft, pliable nylon and
polyester fabrics. They are designed to t around the limb(s) and
fasten with zippers.
The upper extremity garment(s) are used to treat the arm.
Depending on your clinical needs and size, you may be prescribed
a short or long arm garment.

8Customer Service Toll Free: 833.3TACTILE (833.382.2845)
The lower extremity garment(s) are used to treat the leg. Depending
on your clinical needs and size, you may be prescribed a short
or long full leg garment (with corresponding extender), or a half
leg garment.
NOTE: Both Entre and Entre Plus labeled garments can be used with your
Entre Plus controller.
Port Cover. If your healthcare provider ordered unilateral treatment
you will receive a port cover to be placed on the unused port.
2.2 Adjustable Pressure Levels
Your healthcare provider will determine what pressure setting is
appropriate for you. The Entre Plus controller unit allows for selection
of pressure settings (see Figure 2.2.a.). To select the pressure setting
recommended by your healthcare provider press the pressure button
to toggle to the correct pressure setting.
NOTE: Please consult with your healthcare provider before changing
pressure settings.
Version 1.00
PRESSURE
button
Figure 2.2.a. Front Panel

9
2.3 Treating the Lower Extremity
Figure 2.3.b.
Half Leg
Directs uid
from toes to
top of knee in
one continuous
motion.
Figure 2.3.a.
Full Leg
Directs uid
from toes to
top of thigh in
one continuous
motion.
Full Leg Treatment
This option provides full leg
treatment in a distal to proximal
(foot to top of thigh) direction
via the sequential ination
of the eight chambers.
Treatment time: 60 minutes.
Half Leg Treatment
This option provides below
the knee treatment in a distal
to proximal (foot to top of knee)
direction via the sequential
ination of the eight chambers.
Treatment time: 60 minutes.

10 Customer Service Toll Free: 833.3TACTILE (833.382.2845)
2.4 Treating the Upper Extremity
Full Arm Treatment
This option provides full arm treatment in a distal to proximal
(hand to top of biceps) direction via the sequential ination of the
eight chambers.
Treatment time: 60 minutes.
Figure 2.4.a.
Arm
Begins at ngertips
and ends at top of
biceps in one
continuous motion.

11
CHAPTER 3
Controller Unit Set-Up
In this chapter you will learn how to set up the controller unit and
select the proper settings prior to receiving treatment.
3.1 Setting Up the Controller Unit
Follow the steps outlined below:
1. Find an appropriate location for a treatment session (e.g., couch,
bed). Place the controller unit on a sturdy, at surface near an
electrical outlet. Position the device so you have easy access to
the plug.
2. Plug the supplied power adapter into the power adapter inlet on
the back of the controller unit. Then, plug the two-pronged power
adapter into an electrical outlet (Figure 3.1.a.).
NOTE: There are two 12 VDC power adapter options, so the version
shown below may be dierent from the one you receive. The two
versions are:
Meanwell GSM36U12-P1JNX
Fuhua UE36LCP1-120300SPA
A plug adapter
may be necessary for
use outside the U.S.
Figure 3.1.a. Power Adapter

12 Customer Service Toll Free: 833.3TACTILE (833.382.2845)
WARNING: RISK OF ELECTRIC SHOCK
Only use the Meanwell GSM36U12-P1JNX or Fuhua UE36LCP1-120300SPA
power adapter with your Entre Plus system. These power adapters are
designed for use with either 120 Volt AC or 230 Volt AC outlets.
BOTTOM
Tab
Connector Collar
Arrowed Latch Connector
Ensure the arrow is
on top when attaching
the hose connector.
TOP
Ridges
Figure 3.2.a. Hose Connector
3.2 Connecting the Hose to the Controller Unit
The controller unit should be connected to the garments before
the garments are applied.
NOTE: If prescribed unilateral treatment, place the port cover over the
unused port (see Figure 3.2.e.: Properly Sealing Open Port).

13
Follow the steps below to attach the hose to the controller unit:
1. Hold the hose connector by the tabs on the back of the latch
making sure that the arrow is facing up (Figure 3.2.b.).
2.
Align the arrowed latch with the notch on the controller unit port.
3. Reposition your hand so your thumb and ngers are positioned
on the top and bottom latch ridges. This enables you to slide the
latch (Figure 3.2.c.).
Figure 3.2.b. Connecting the Hose to the Controller Unit
Figure 3.2.c. Proper Handling of the Hose Connector

14 Customer Service Toll Free: 833.3TACTILE (833.382.2845)
4. Push the latch forward; it will hook on the top and bottom of the
controller unit 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 3.2.d.).
5. If using only one garment, ensure that one of the controller ports
is sealed with the port cover (Figure 3.2.e.).
Figure 3.2.d. Properly Connecting the Latches
Figure 3.2.e. Properly Sealing Open Port

15
CHAPTER 4
Garment Application
Prior to starting treatment it is important to:
1. Be sure you have the recommended garment(s) to complete
your treatment.
2. Choose a time that will limit interruptions that would require you
to pause treatment. The treatment session lasts one hour.
CAUTION
To avoid skin irritation that may result from contact with the polyester
material, wear lightweight, loose-tting (non-elastic) cotton clothing
(example: scrubs, stockinette). If skin irritation develops, consult with
your doctor.
Lymph uid is moved through the vessels in the skin. It is important
to avoid wearing anything during treatment that may hamper the
lymph ow. These items include:
Belts
Jewelry
Restrictive clothing such as: Elastic-banded underwear, Compression
bandaging, Elastic-banded socks, compression garments, Bra
CAUTION
The Entre Plus garments should not be placed in direct contact
with an open wound. It is recommended that wounds be properly
dressed before the garment is applied. Contact your healthcare
provider if you have any questions.

16 Customer Service Toll Free: 833.3TACTILE (833.382.2845)
4.1 Applying the Full Leg and Half Leg Garment
Garment Preparation:
1. Once the garment is connected to the controller unit, unfold and
place the full leg or half leg garment(s) on the bed or sofa with the
inside garment material (darker fabric) facing up.
2. Congure your garment(s) using the zipper conguration
indicated on your Prescribed Treatment Card. Zip the appropriate
pull string color (teal or black) to the numbered zipper (#1 or #2).
Use the colored zipper to start the zipper. The following zipper
congurations are available:
Black pull string to zipper #1 – Petite
Black pull string to zipper #2 – Small
Teal pull string to zipper #1 – Medium
Teal pull string to zipper #2 – Large
NOTE: If you are using an extender, position it so the narrow side is
located at the foot of the leg garment. Connect the teal pull string
located on the leg garment to the zipper on the extender. Then,
connect the teal pull string located on the extender to the #2 zipper on
the leg garment.
3. Zip the garment up half way.
Garment Application:
4. Sit down and slide your leg into the garment (see Figure 4.1.a.).
Pull the garment up to the top of your thigh (full leg garment) or
knee (half leg garment); your foot should not exit the front of the
garment. Zip the garment up completely and ensure the zipper
pull is at against the base to lock the zipper in place.
NOTE: If the suggested conguration is too tight or too loose,
try another conguration based on the listings above.

17
Figure 4.1.b. Fully Applied Full Leg or Half Leg Garment
Figure 4.1.a. Applying the Full Leg or Half Leg Garment
5. Finally, place a pillow under your calf and foot to elevate your leg
slightly above your hips for optimal treatment (Figure 4.1.b.).
4.2 Applying the Arm Garment
Garment Preparation:
1. Once the garment is connected to the controller unit, unfold
and place the arm garment(s) on the bed or sofa with the zipper
facing up.