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.