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Tactile Medical ENTRE PD08-U User Manual

Pneumatic compression device
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Summary of Contents for Tactile Medical ENTRE PD08-U

  • Page 1 User Guide...

  • Page 2: Table Of Contents

    1 .1 How to Contact Tactile Medical . . . . . . . . . . . . . . . . .
  • Page 3 Chapter 6 Troubleshooting and Specifications . . . . . . 24 Chapter 7 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 7 .1 Limited Warranty and Service for Home Use .

  • Page 4: Before You Get Started

    . This guide provides the information needed to set up and use your Entre system . How to Contact Tactile Medical If you have questions about the Entre system or require service, contact Tactile Medical: •...

  • Page 5: Safety Precautions And Explanation Of Symbols

    . 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 833 .382 .2845 (833 .3 TACTILE ) (toll free, U .S . only) to get disposal instructions .
  • Page 6 • 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 or repair . Do not modify the power adapter or plug .

  • Page 7: Indications For Use

    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 .

  • Page 8: Contraindications

    Contraindications The Entre 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) •...

  • Page 9: Labels

    Lower Extremity Treatment The garments and device accessory(ies) needed for lower extremity treatment may include the following: • Full leg garment • Half leg garment • “Y” connector (provided only if bilateral therapy is ordered) • Extender (provided only if ordered) Upper Extremity Treatment The garments and device accessory needed for upper extremity treatment may include the following:...

  • Page 10: The Entre System

    C H A P T E R 2 The Entre System The Entre system is a pneumatic compression device that delivers intermittent sequential compression therapy 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 system.

  • Page 11: Adjustable Pressure Levels

    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 . The “Y” connector. If your healthcare provider ordered bilateral treatment you will receive a “Y”...

  • Page 12: Treating The Lower Extremity

    Treating the Lower Extremity Full Leg Treatment Half Leg Treatment This option provides full leg This option provides below treatment in a distal to proximal the knee treatment in a distal to (foot to top of thigh) direction proximal (foot to top of knee) via the sequential inflation of direction via the sequential the 8 chambers .

  • Page 13: Treating The Upper Extremity

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

  • Page 14: Controller Unit Set-Up

    C H A P T E R 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 therapy . Setting Up the Controller Unit Follow the steps outlined below: 1 .

  • Page 15: Connecting The Hose To The Controller Unit

    WARNING: RISK OF ELECTRIC SHOCK Only use the Meanwell GSM36U12-P1JNX or Fuhua UE36LCP1-120300SPA power adapter with your Entre system . These power adapters are designed for use with either 120 Volt AC or 230 Volt AC outlets . Connecting the Hose to the Controller Unit The controller unit should be connected to the garments before the garments are applied .
  • Page 16 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 .
  • Page 17 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) .

  • Page 18: Chapter 4 Garment Application

    C H A P T E R 4 Garment Application Prior to starting therapy it is important to: 1 . Be sure you have the recommended garment(s) to complete your therapy . 2 . Choose a time that will limit interruptions that would require you to pause therapy .

  • Page 19: Applying The Full Leg And Half Leg Garment

    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 .

  • Page 20: Applying The Arm 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) . Figure 4.1.b: Fully Applied Full Leg or Half Leg Garment Applying the Arm Garment Garment Preparation: 1 .
  • Page 21 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: •...

  • Page 22: Conducting A Therapy Session

    C H A P T E R 5 Conducting a Therapy Session Once you have connected your garment to the controller unit and applied the garment to your limb, you are ready for your therapy session with the Entre system . Start your therapy session using the instructions below .

  • Page 23: Starting The Therapy Session

    Figure 5.1.a: Front Panel PRESSURE button START/PAUSE button ON/OFF button 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 limb(s) during the therapy session .

  • Page 24: Pausing The Therapy Session

    Pausing the Therapy Session You may pause treatment for up to 15 minutes at any point during a therapy session by pressing the START/PAUSE button . To resume your therapy session, press the START/PAUSE button . NOTE: The controller unit will remain paused for up to fifteen minutes. After that time, the controller unit will automatically turn off, requiring you to restart your therapy session.

  • Page 25: Cleaning The Entre System

    3 . Store the controller unit, garments (and “Y” connector, if supplied) 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 . Cleaning the Entre System To clean the controller unit and/or garments (and “Y”...

  • Page 26: Disinfecting The Entre System

    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 .

  • Page 27: Troubleshooting And Specifications

    C H A P T E R 6 Troubleshooting and Specifications If you experience a problem with the Entre 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 at 612 .355 .5100 or 833 .382 .2845 (833 .3 TACTILE ) (toll free, U .S .
  • Page 28 Problem Recommended Solution Controller The controller unit was unable to produce or maintain unit does pressure in any of the garment chambers . not function, 1 . Power down the device . If able, disconnect the garment and the LOW from the controller unit and then reconnect again .
  • Page 29 Problem Recommended Solution Cannot change Once you start a treatment, settings cannot be changed pressure unless: setting. • The treatment program has completed . • The treatment is paused . • The ON/OFF button is pressed . To change pressure setting while a therapy session is in progress, first press the START/PAUSE button .
  • Page 30 3 . Restart the treatment by pressing the START/PAUSE button . 4 . If the noise continues, contact Customer Service *Tactile Medical Customer Service can be contacted at 612.355.5100 or 833.382.2845 (833.3 TACTILE ) (toll free, U.S. only) 7 a.m. to 7 p.m. Central Time, Monday–Friday.

  • Page 31: Chapter 7 Warranty

    Entre 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 .

  • Page 32: Limited Warranty And Service For Facility Use

    . This warranty is available only to the original user and is not transferable . Repairs or alterations to the product not conducted by Tactile Medical shall void these warranties . These warranties do not cover failures due to improper or negligent use of the product .

  • Page 33: Chapter 8 Technical Information

    C H A P T E R 8 Technical Information Technical Information The Entre system has the following characteristics: Table 4: Entre System – Technical Information Model Number PD08–U 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...
  • Page 34 Table 5: Entre System – Classification Information US FDA Medical Device Class II per 21 CFR 870 .5800 & 21 CFR 890 .5650 Canada Medical Device Class II per Canadian Medical Device Regulation 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...
  • Page 35 Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Entre system is intended for use in the electromagnetic environment specified below . The customer or the user of the Entre should assure that it is used in such an environment .
  • Page 36 Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued) The Entre system is intended for use in the electromagnetic environment specified below . The customer or the user of the Entre should assure that it is used in such an environment .

  • Page 37: Device Labels

    — 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: •...
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  • Page 39 This page has intentionally been left blank . Customer Service Toll Free 833.382.2845 (833.3 TACTILE )

  • Page 40: For Additional Questions

    .com Entre and Healing Right at Home are trademarks 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 .

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