Tactile MEDICAL PD08-NG Entre Plus Pneumatic Compression System User Guide

PD08-NG Entre Plus Pneumatic Compression System

Product Information: Model PD08-NG Pneumatic Compression

System

The Model PD08-NG is a pneumatic compression system designed for
home or facility use. The system includes a controller unit, hoses,
and garment attachments for applying compression to the legs and
arms. The system is intended to improve circulation and reduce
swelling in individuals with lymphedema, venous insufficiency, or
other edema-related conditions.

Safety Precautions and Explanation of Symbols

Before using the Model PD08-NG, it is important to read the
entire guide and keep it available for future reference. The
following safety precautions and symbols should be noted:

• Consult a physician or healthcare provider before using the
  product.

• Use the product only at the settings prescribed by your
  healthcare provider.

• Read all instructions before attempting to connect or operate
  the product.

• Do not dispose of the product with general household waste;
  contact Tactile Medical for disposal instructions.

• The product is restricted by U.S. Federal law to sale by or on
  the order of a licensed healthcare professional.

Product Usage Instructions

Chapter 1: Before You Get Started

If you have questions about the Entre Plus system or require
service, contact Tactile Medical. Before using the product, read
all instructions and keep the guide available for future
reference.

Chapter 2: The Entre Plus System

The Entre Plus system includes a controller unit, hoses, and
garment attachments for applying compression to the legs and
arms.

Chapter 3: Controller Unit Set-Up

To set up the controller unit, follow these steps:

1. Connect the power cord to an electrical outlet and the
   controller unit.

2. Press the power button to turn on the unit.

3. Select the appropriate pressure level and treatment time as
   prescribed by your healthcare provider.

To connect the hose to the controller unit, follow these
steps:

1. Insert the end of the hose into the connector on the controller
   unit.

2. Twist the hose clockwise until it clicks into place.

Chapter 4: Garment Application

The Entre Plus system includes garment attachments for applying
compression to the legs and arms. Follow these instructions for
applying the garments:

• Full Leg and Half Leg Garment:

  1. Place the foot into the garment and pull it up to the thigh or
     knee.

  2. Wrap the straps around the leg and secure them with the Velcro
     tabs.

• Arm Garment:

  1. Place the hand into the garment and pull it up to the shoulder
     or elbow.

  2. Wrap the straps around the arm and secure them with the Velcro
     tabs.

Chapter 5: Conducting a Treatment Session

To conduct a treatment session, follow these steps:

1. Connect the hose to the garment attachment.

2. Place the garment attachment on the desired area, making sure
   it is snug but not too tight.

3. Press the start button on the controller unit to begin
   treatment.

4. When treatment is complete, press the stop button to turn off
   the unit.

Chapter 6: Troubleshooting and Specifications

Refer to the troubleshooting section of the guide for assistance
with any issues that may arise during use of the product. The
product specifications are also provided in this chapter.

Chapter 7: Warranty

The Model PD08-NG comes with a limited warranty and service for
home or facility use. Refer to this chapter for details on the
warranty and return policy.

Chapter 8: Technical Information

This chapter provides technical information and device labels
for the product.

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

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 insufficiency 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, Monday­Friday . By email: info@tactilemedical .com . If you have medical questions, please contact your physician or healthcare provider .
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1.2 Safety Precautions and Explanation of Symbols

IMPORTANT: Read Instructions Before Using Before attempting to connect or operate this product, please read the entire guide . Keep this guide available for future reference .
CAUTION
Manufacturer’s 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, fire 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 .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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 inflation and deflation of the garment chambers in a defined 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 affected 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 .
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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 flammable gasses, including flammable 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 insufficiency
Chronic wounds

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory 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 find the following:

Controller unit

Power adapter

Garment(s) and accessory(ies) to treat your condition

Quick Start Guide

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) .

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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

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

CHAPTER 2
The Entre Plus System
The Entre Plus system is a pneumatic compression device that delivers intermittent sequential compression treatment to the affected extremities of patients with lymphedema, chronic edema, venous insufficiency, 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 different levels of pressure along the length of your limb . For example, your toes or fingers 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 fit 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 .
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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.
Figure 2.2.a. Front Panel
Version 1.00

PRESSURE button

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

2.3 Treating the Lower Extremity

Full Leg Treatment This option provides full leg treatment in a distal to proximal (foot to top of thigh) direction via the sequential inflation of the eight chambers .

Half Leg Treatment This option provides below the knee treatment in a distal to proximal (foot to top of knee) direction via the sequential inflation of the eight chambers .

Treatment time: 60 minutes .

Treatment time: 60 minutes .

Figure 2.3.a. Full Leg Directs fluid from toes to top of thigh in one continuous motion .
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Figure 2.3.b. Half Leg Directs fluid from toes to top of knee in one continuous motion .

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 inflation of the eight chambers . Treatment time: 60 minutes .
Figure 2.4.a. Arm Begins at fingertips and ends at top of biceps in one continuous motion .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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, flat 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 different from the one you receive. The two versions are:
Meanwell GSM36U12-P1JNX Fuhua UE36LCP1-120300SPA
Figure 3.1.a. Power Adapter
A plug adapter may be necessary for use outside the U.S.
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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 .

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).

Tab Ridges
Connector Collar

Figure 3.2.a. Hose Connector TOP Arrowed Latch Connector
Ensure the arrow is on top when attaching the hose connector.

BOTTOM

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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.) .
Figure 3.2.b. Connecting the Hose to the Controller Unit
2 . Align the arrowed latch with the notch on the controller unit port . 3 . Reposition your hand so your thumb and fingers are positioned
on the top and bottom latch ridges . This enables you to slide the latch (Figure 3.2.c.) .
Figure 3.2.c. Proper Handling of the Hose Connector
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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.) .
Figure 3.2.d. Properly Connecting the Latches
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.e. Properly Sealing Open Port

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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-fitting (non-elastic) cotton clothing (example: scrubs, stockinette) . 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 treatment 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
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 .
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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 . Configure your garment(s) using the zipper configuration 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 configurations 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 flat against the base to lock the zipper in place .
NOTE: If the suggested configuration is too tight or too loose, try another configuration based on the listings above.

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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.) .
Figure 4.1.b. Fully Applied Full Leg or Half Leg Garment
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 .
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2 . Configure your garment(s) using the zipper configuration 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 configurations 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
3 . Zip the garment up completely and ensure the zipper pull is flat against the base to lock the zipper in place .
Garment Application: 4 . Slide your arm into the garment .
NOTE: If the suggested configuration is too tight or too loose, try another configuration based on the listings above.
5 . Pull the arm garment up over your shoulder making sure your fingertips remain fully enclosed in the garment . The zipper should align with the top of your shoulder .

Figure 4.2.a. Preparing the Arm Garment

Figure 4.2.b. Slide the
Arm Garment On

Figure 4.2.c. Fully Applied Arm Garment

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

CHAPTER 5
Conducting a Treatment Session
Once you have connected your garment to the controller unit and applied the garment to your limb, you are ready for your treatment session with the Entre Plus system . Start your treatment session using the instructions below .
5.1 Selecting Your Pressure Setting
Follow the steps outlined below to select the settings prescribed by your healthcare provider: NOTE: The controller unit will recall the pressure setting used during the last treatment session. In most situations the pressure settings will not need to be modified from one treatment to the next.

1. Turn the controller unit ON.
   Turn on the controller unit by pressing the button located on the front panel (Figure 5.1.a.) . The LCD screen will illuminate . 2. Select the pressure setting prescribed by your physician. The button allows you to toggle between the three pressure levels: low, medium and high . Select the prescribed pressure setting listed on your Prescribed Treatment Card .
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Figure 5.1.a. Front Panel
Version 1.00

ON/OFF button

PRESSURE button

START/PAUSE button

5.2 Starting the Treatment Session
1 . Prepare yourself for an uninterrupted treatment session .
2 . Lay down on your back with your hips and legs positioned straight . Do not sit in a chair or bend your affected limb(s) during the treatment session .
3 . Elevate the affected limb(s) on a pillow just above your hips .
4 . Check your pressure setting to ensure you have selected the correct pressure .
5 . When properly positioned, press the button on the controller unit to begin the treatment session .
6 . For best results, relax and take deep abdominal breaths during the treatment session .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

5.3 Pausing the Treatment Session
You may pause treatment for up to 15 minutes at any point during a treatment session by pressing the button . To resume your treatment session, press the button . NOTE: The controller unit will remain paused for up to 15 minutes. After that time, the controller unit will automatically turn off, requiring you to restart your treatment session.
5.4 Completing the Treatment Session
The treatment program will automatically stop once the treatment is complete . The LCD screen will display “Successfully Completed”; at this time the garment will begin to deflate . NOTE: Do not turn off or disconnect the garment during this deflation process.
CAUTION If an electrical power outage or power interruption occurs during a treatment session, the garment(s) may remain inflated . To remove the garment from your extremity, it may be necessary to disconnect hose connector from the controller unit to allow release of the trapped air .
5.5 Storing the Entre Plus System
To store the Entre Plus system, follow the steps outlined below: 1 . Unplug the power adapter cord from the controller unit and from
the electrical outlet . 2 . Store the garments by first coiling the tubing for each of the
supplied garments . Avoid kinking the tubing . Garments can be folded . Do not stack anything on top of them .
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3 . Store the controller unit and garments in a cool, dry place . Keep them out of excessive heat or cold . (See Chapter 8 for allowable storage temperatures .) Store them away from children and pets .
5.6 Cleaning the Entre Plus System
To clean the controller unit and/or garments, follow the steps outlined below .

CAUTION: Read all instructions before cleaning

Do not submerge

Do not machine wash

Do not disassemble

Do not dry clean

Do not machine dry

Do not autoclave

Do not iron

Do not steam sterilize

WARNING: Risk of Electric Shock Unplug the power adapter cord from the electrical outlet prior to cleaning the controller unit . Allow the controller unit to dry completely prior to connecting the power adapter to the electrical outlet .

Cleaning the Controller Unit The controller unit can be cleaned, as needed, using a damp cloth and mild household cleaner: 1 . Unplug the power adapter from the electrical outlet .
2 . Wipe all accessible surfaces, including the power adapter .
3 . After cleaning, allow the unit to dry completely prior to using .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

Cleaning the Garment(s) 1 . A lint brush or roller may be used to remove particles on the inside
of the garment(s) . 2 . The outside portion of the garment(s) may be cleaned using a
damp cloth and a mild detergent . 3 . Allow garment(s) and accessories to dry thoroughly prior to using .
5.7 Disinfecting the Entre Plus 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 Entre Plus 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 Entre Plus 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 .
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CHAPTER 6
Troubleshooting and Specifications

If you experience a problem with the Entre Plus system, refer to the information in Table 1 for assistance . If the information in Table 1 does not help solve the problem, call Customer Service toll free at 833 .3TACTILE (833 .382 .2845) .

Problem

Table 1: Troubleshooting
Recommended Solution

Controller unit does not function or display does not illuminate .

1 . Disconnect the power adapter from the back of the controller unit and then reconnect . Ensure that the power adapter is fully inserted in both the power inlet on the back of the controller unit and the wall outlet . Ensure the wall outlet is functioning . A green light will illuminate on the power adapter if the wall outlet and power adapter are functioning .
2 . Press the button .

The chambers do not fill with air (controller screen may indicate the treatment completed with result R3, R4, R5, R6, R7 or R8).

The controller unit detected the system’s pressure is too high (most likely due to kinked tubing) .
1 . Power down the device . If able, disconnect the garment from the controller unit and then reconnect again . Power up the device by pressing the button . Restart the treatment session by pressing the button .
2 . Ensure the garment tubing is not kinked in any way, as this is the most common reason for the problem .
3 . Do not stand on garment during treatment .
4 . To confirm proper functioning of the controller unit and garment, you may take the garment off and lay it flat on the floor, power up the device and press the button to begin a treatment session and confirm all chambers sequentially inflate .
5 . Please call Customer Service* for assistance if you are unable to resolve the problem .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

Problem Controller unit does not work, and the garments do not inflate
Controller unit does not function, and holds pressure in the garments.
Controller unit does not function, and an error message appeared on the LCD screen. Cannot change pressure setting.

Recommended Solution
The controller unit was unable to produce or maintain pressure in any of the garment chambers .
1 . Power down the device . If able, disconnect the garment from the controller unit and then reconnect again . Power up the device by pressing the button . Restart the treatment session by pressing the button .
2 . Please call Customer Service if you are unable to resolve the problem .
The controller unit was unable to release pressure from the system .
1 . Power down the device . If able, disconnect the garment from the controller unit and then reconnect again . Power up the device by pressing the button . Restart the treatment session by pressing the button .
2 . Please call Customer Service if you are unable to resolve the problem .
The controller unit detected an issue during self-test .
1 . Power down the device . Power up the device by pressing the button . Restart the treatment session by pressing the button .
2 . Please call Customer Service* if you are unable to resolve the problem .
Once you start a treatment, settings cannot be changed unless:
The treatment program has completed .
The button is pressed .
To change pressure settings, power off the device . Then power up the device by pressing the button . Then settings may be adjusted by pressing the button .

25

Problem The garment chambers do not fill with air.
Garment pressures are higher or lower than expected.
Garment remains inflated.
Controller unit runs longer than expected.

Recommended Solution
1 . Verify the and buttons have been pressed . (The LCD screen will illuminate when the button is pressed .)
2 . Verify that the connectors are attached properly and that the hoses are not kinked .
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 button to begin a treatment session . 6 . Feel for air coming out of the controller unit, reconnect
the hose . If using only one garment, ensure the port is attached according to Section 3 .2 step 5 .
1 . Verify that the correct pressure has been selected .
2 . Adjust the fit of the garment, ensuring no folds or kinks are in the fabric .
3 . Check to be sure the latches are firmly in place and attached properly .
It is normal for a small amount of air to remain in the chambers between inflations, giving the garment a puffy appearance . If the chambers remain fully inflated:
1 . Press and hold the button for at least three seconds to start the active exhaust process .
2 . Ensure that the tubing is not kinked or pinched .
3 . Disconnect the connectors and the chambers should deflate .
A treatment session will last approximately 60 minutes . Please call Customer Service* (toll free) if controller unit runs significantly longer than 60 minutes .

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

Zippers have broken or become disconnected from garment.
Problem
Any button does not function.
The controller unit makes an abnormal noise.

Please call Customer Service (toll free) for assistance .
Recommended Solution 1 . Power down the device . Power up the device by pressing
the button . 2 . Please call Customer Service (toll free) for instructions . 1 . Stop the treatment session by pressing the button . 2 . Verify the noise has stopped . 3 . Restart the treatment by pressing the button . 4 . If the noise continues, stop the treatment by pressing
the button and contact Customer Service* .

*Tactile Medical Customer Service can be contacted toll free at 833.3TACTILE (833.382.2845), 7 a.m. to 7 p.m. CT, Monday­Friday.

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CHAPTER 7
Warranty
7.1 Limited Warranty and Service for Home Use
Tactile Medical provides a warranty for the Entre Plus system . The Entre Plus Controller unit, garments and garment accessories are warranted to be free from defects in material and workmanship for a period of 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 . Replacement parts may be new or reconditioned 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 Entre Plus 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, REPLACEMENT OR PERFORMANCE OF THE ENTRE PLUS 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 .

28

Customer Service Toll Free: 833.3TACTILE (833.382.2845)

This warranty is available only to the original user and is not transferable . 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 .
7.2 Limited Warranty and Service for Facility Use
Contact Tactile Medical for information regarding the service agreements available to facilities .
7.3 Return Policy
Returns are accepted for unopened product within 60 days of receipt . Products, such as replacement controllers, garments or accessories outside or not covered by the warranty, are available for purchase .
7.4 Equipment Lifetime
When used and maintained as instructed, the average expected controller unit lifetime is five (5) years . Tactile Medical reserves the right to modify product specifications as part of its continuing program of product development and quality improvement .
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CHAPTER 8
Technical Information

8.1 Technical Information
The Entre Plus system has the following characteristics:

Table 4: Entre Plus System ­ Technical Information

Model Number

PD08­NG

Power Adapter Input

100~240 VAC

Voltage/Frequency

47~63 Hz

Power Adapter Input Current 0 .9-0 .45 A

Device Input Voltage

12 VDC Nominal

Device Input Current

3 .0 A Maximum

Pressure Settings

HIGH, MED and LOW

Controller Unit Size

9 .0″ x 8 .5″ x 5 .0″ (228 mm x 215 .9 mm x 127 mm)

Controller Unit Weight

5 .5 lbs . (2 .2 kgs)

Fabrics

Nylon and polyester . Not made with natural rubber latex .

Therapy Programs

1

Chambers

8

Mode of Operation

Continuous

Calibration

Recalibration not required

Electromagnetic Interference (EMI) Electromagnetic Compatibility (EMC)

The Entre Plus 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 EMC standards . See Tables 6, 7 and 8 .

Operating Atmospheric Pressure

700 to 1060 hPa

Device Transport Device Operating

and Storage

Temperature Limits

Temperature Limits

Device Transport and Storage
Humidity Limits

Device Operating Humidity Limits

30

Customer Service Toll Free: 833.3TACTILE (833.382.2845)

Table 5: Entre Plus System ­ Classification Information

U .S . FDA Medical Device

Class II per 21 CFR 870 .5800

Protection Against Electric Shock Hazard Class I per UL/EN/IEC 60601-1

Protection Against Fluid Ingress

IP21

Applied Part

BF

Table 6: Entre Plus System ­ Conformance Information

Quality Assurance

FDA 21 CFR 820 QSR ISO 13485

Safety

IEC 60601-1 CAN/CSA C22 .2 No . 601 .1

Electromagnetic Compatibility (EMC) IEC 60601-1-2

Waste Electrical & Electronic Equipment Directive 2002/96/EC (WEEE)

Restriction of Hazardous Substances Directive 2002/95/EC

Table 7: Guidance and Manufacturer’s Declaration ­ Electromagnetic Emissions

The Entre Plus system is intended for use in the electromagnetic environment specified below . The customer or the user of the Entre Plus system should assure that it is used in such an environment .

Emissions Test

Compliance Electromagnetic Environment ­ Guidance

RF emissions CISPR 11

Group 1

The Entre Plus system uses RF energy only for its internal function . Therefore, its RF emissions are very low and are not likely to cause interference to nearby electronic equipment .

RF emissions CISPR 11

Class B

Harmonic emissions Not Applicable IEC 61000-3-2

Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3

The Entre Plus system is suitable for use in all establishments, including domestic establishments and those connected to the public low-voltage power adapter network that supplies buildings used for domestic purposes .

31

Table 8: Guidance and Manufacturer’s Declaration ­ Electromagnetic Immunity

The Entre Plus system is intended for use in the electromagnetic environment specified below . The customer or the user of the Entre Plus 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
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5

± 6 kV contact ± 8 kV air

± 8 kV contact +/-2 kV, +/-4 kV, +/-8 kV, +/-15 kV air

Floors should be wood, concrete or ceramic tile . If floors are covered in synthetic material, the relative humidity should be at least 30% .

± 2 kV for power supply lines
± 100 kHZ repetition

± 2 kV for power supply lines
± 100 kHZ repetition

Mains power quality should be that of a typical commercial or hospital environment .

± – .5 kV

± – .5 kV

± -1 kV line to line ± -1 kV line to line

± – .5 kV

± – .5 kV

± -1 kV

± -1 kV

± -2 kV line to earth ± -2 kV line to earth

Voltage dips, short interruptions and voltage variations on power adapter lines IEC 61000-4-11

Voltage dips
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle and 70% UT; 25 periods at 50Hz, 30 periods at 60Hz
Single phase: at 0°
Voltage Interruptions 0% UT; 250 periods at 50Hz, 300 periods at 60Hz

Voltage dips
0% UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle and 70% UT; 25 periods at 50Hz, 30 periods at 60Hz
Single phase: at 0°
Voltage Interruptions 0% UT; 250 periods at 50Hz, 300 periods at 60Hz

Mains power quality should be that of a typical commercial or hospital environment . If the user of the Entre Plus system requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power adapter .

NOTE UT is the a .c . mains voltage prior to application of the test level .

32

Customer Service Toll Free: 833.3TACTILE (833.382.2845)

Table 8: Guidance and Manufacturer’s Declaration ­ Electromagnetic Immunity (continued)

The Entre Plus system is intended for use in the electromagnetic environment specified below . The customer or the user of the Entre Plus should assure that it is used in such an environment .

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment ­
Guidance

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 .

Conducted

3 Vrms 150 kHz to 3 Vrms .15 kHz to

RF IEC 61000-4-6 80 MHz

80 MHz

6 Vrms in ISM and amateur radio bands between 0 .15 MHz and 80 MHz 80% AM at 1 kHz

6 Vrms in ISM and amateur radio bands between 0 .15 MHz and 80 MHz 80% AM at 1 kHz

Radiated RF IEC 61000-4-3

10 V/m 80 MHz to 2,7 GHz 80 AM at 1kHz

10 V/m 80 MHz to 2,7 GHz 80 AM at 1kHz

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 Entre Plus system is used exceeds the applicable RF compliance level above, the Entre Plus 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 Entre Plus system .

33

8.2 Device Labels
The device labels are found on the back and bottom of your device . To read the labels, place the device facing away from you at eye level at a distance that maximizes character clarity — generally 20 inches (50 cm) to 40 inches (100 cm) with an illumination of 500 lx minimum .
Call Tactile Medical Customer Service if label reading issues remain .
NOTE: Device labels are not to scale. Device labels depiction may be different than that on your device. See page 2 for symbol definitions.

34

Customer Service Toll Free: 833.3TACTILE (833.382.2845)

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Customer Service Toll Free: 833.3TACTILE (833.382.2845)

For Additional Questions
If you have any questions that are not covered by this User Guide, contact:
By mail: Tactile Medical, 3701 Wayzata Blvd, Suite 300 Minneapolis, MN 55416 U .S .
By phone: Toll free: 833 .3TACTILE (833 .382 .2845) Hours: 7 a .m . to 7 p .m . CT, Monday­Friday
By fax: Toll free: 866 .435 .3949
By email: info@tactilemedical .com
Visit: tactilemedical .com

Tactile Medical 3701 Wayzata Blvd, Suite 300 Minneapolis, MN 55416 USA T: 612 .355 .5100 F: 612 .355 .5101

Customer Care Toll Free Tel: 833 .3TACTILE (833 .382 .2845) Toll Free Fax: 866 .435 .3949 Hours: 7 a .m . to 7 p .m . CT, Monday­Friday tactilemedical .com

Tactile Medical and Entre are registered trademarks and Healing Right at Home is a trademark of Tactile Medical . DisCide® is a registered trademark of Palmero Health Care Corporation . 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 .
©2023 Tactile Medical . All rights reserved . 701770-001 Rev E 02/2023

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