Related Manuals for Tactile Medical Entre Plus
Summary of Contents for Tactile Medical Entre Plus
- Page 1 Entre Plus User Guide ® Model PD08-NG E N T R E ® PLU S PNEUMATIC COMPRESSION SYSTEM...
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Page 2: Table Of Contents
5 . 7 Disinfecting the Entre Plus System . . . . . . . . . . . . . . . . - Page 3 Chapter 6 Troubleshooting and Specifications . . . . . . 24 Chapter 7 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 7 .
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Page 4: Before You Get Started
This guide provides the information needed to set up and use your Entre Plus system . 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 . -
Page 5: Safety Precautions And Explanation Of Symbols
Product Category CCN: PIDF Class II with respect to electrical shock, fire and mechanical hazards only in accordance with EN60601-1 The Entre Plus system complies with IEC60329 regarding the IP21 degree of protection against water and particulates . Customer Service Toll Free: 833.3TACTILE (833.382.2845) - Page 6 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 .
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Page 7: Indications For Use
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 . -
Page 8: Contraindications
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) -
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 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... -
Page 10: The Entre Plus System
C H A P T E R 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 . -
Page 11: Adjustable Pressure Levels
(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 . -
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 (foot to top of thigh) direction to proximal (foot to top of knee) via the sequential inflation direction via the sequential of the eight 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 eight chambers . Treatment time: 60 minutes . Figure 2.4.a. Begins at fingertips and ends at top of biceps in one... -
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 treatment . 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 Plus 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.) Figure 3.2.d.
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Page 18: Chapter 4 Garment Application
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... -
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: Black pull string to zipper #1 –...
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Page 22: 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 . Selecting Your Pressure Setting... -
Page 23: Starting The Treatment Session
Figure 5.1.a. Front Panel ON/OFF PRESSURE START/PAUSE button button button 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 . -
Page 24: Pausing The Treatment Session
. 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 . -
Page 25: Cleaning The Entre Plus System
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 Plus System To clean the controller unit and/or garments, follow the steps outlined below . -
Page 26: Disinfecting The Entre Plus System
. 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 . 1 030) and/or registered with EPA . To disinfect... -
Page 27: Troubleshooting And Specifications
C H A P T E R 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) . - Page 28 Problem Recommended Solution Controller The controller unit was unable to produce or maintain unit does not pressure in any of the garment chambers . work, and the 1 . Power down the device . If able, disconnect the garment garments do from the controller unit and then reconnect again .
- Page 29 Problem Recommended Solution The garment 1 . Verify the buttons have been pressed . chambers do (The LCD screen will illuminate when the button not fill with air. is pressed . ) 2 . Verify that the connectors are attached properly and that the hoses are not kinked .
- Page 30 3 . Restart the treatment by pressing the button . 4 . If the noise continues, stop the treatment by pressing 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, Monday–Friday.
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Page 31: Chapter 7 Warranty
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 . -
Page 32: Limited Warranty And Service For Facility Use
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 . -
Page 33: Chapter 8 Technical Information
Mode of Operation Continuous Calibration Recalibration not required Electromagnetic Interference The Entre Plus system was designed to minimize the (EMI) Electromagnetic effects of external EMI upon the device and to minimize Compatibility (EMC) the effect upon the environment from the device . - Page 34 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 –...
- Page 35 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...
- Page 36 . 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 .
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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: Device labels are not to scale. - Page 38 This page has intentionally been left blank .
- Page 39 This page has intentionally been left blank . Customer Service Toll Free: 833.3TACTILE (833.382.2845)
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Page 40: For Additional Questions
.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 .