Mego Afek Lympha Press PCD-52 737A User Manual

Mego Afek Lympha Press PCD-52 737A User Manual

Sequential compression therapy system

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PCD-52™
Model 737A
Sequential Compression Therapy System
User Manual
L98005H1-F

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Summary of Contents for Mego Afek Lympha Press PCD-52 737A

  • Page 1 PCD-52™ Model 737A Sequential Compression Therapy System User Manual L98005H1-F...
  • Page 3: Table Of Contents

    User Manual: PCD-52™ 737A Table of Contents Important - Before you Start ..............iii Indications ..................... iv Contraindications..................v Symbols used in this Manual ..............v Safety Warnings and Precautions ............vi Labels and Symbols on the Console, Garments, and/or Packaging ..viii 1.
  • Page 4 Copyright © 2019 by: Mego Afek AC Ltd. All rights reserved. No part of this manual may be reproduced or copied in any form by any means including graphic, electronic or mechanical media, photocopying, typing, or other information retrieval systems, without the written permission of Mego Afek AC Ltd. L98005H1-F...
  • Page 5: Important - Before You Start

    User Manual: PCD-52™ 737A Important - Before you Start 1. Read this entire manual before setting up and operating the PCD-52™ system. Keep the manual for future reference. 2. Keep all packing materials in case you need to transport the console. The packing materials have been designed to protect the system from damage during shipment.
  • Page 6: Indications

    User Manual: PCD-52™ 737A Indications PCD-52™ is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: • Primary lymphedema • Secondary lymphedema • Venous insufficiency • Venous stasis ulcers • Dysfunction of the muscle pump •...
  • Page 7: Contraindications

    User Manual: PCD-52™ 737A Contraindications Use of the PCD-52™ system is not recommended in the presence of one or more of the following conditions: • Known or suspected deep vein thrombosis (DVT) or pulmonary embolism • During the inflammatory phlebitis process •...
  • Page 8: Safety Warnings And Precautions

    User Manual: PCD-52™ 737A Safety Warnings and Precautions Warning: Explosion Hazard Do not use the PCD-52™ system in the presence of flammable gases, including flammable anesthetics. Warning: Electric Shock Hazard Do not allow liquid to enter any part of the PCD-52™ console. Do not immerse.
  • Page 9 User Manual: PCD-52™ 737A Caution: Do not operate the PCD-52™ system during transit. Caution: Do not store or transport the PCD-52™ system beyond the specified temperature, humidity, and atmospheric pressure ranges (see Section 8.3 - Storage). Caution: Do not use the PCD-52™ system beyond the specified temperature range: 10 to 30°C (50 to 86°F).
  • Page 10: Labels And Symbols On The Console, Garments, And/Or Packaging

    User Manual: PCD-52™ 737A Labels and Symbols on the Console, Garments, and/or Packaging Symbol Description Location IP21 Degree of protection against ingress of water On console base Read instructions before use On console base Read instructions before use (for China only) On console base Read instructions before use On garment label...
  • Page 11 User Manual: PCD-52™ 737A Symbol Description Location For use by or on the order of a physician On console base Fragile, handle with care On package Keep dry On package This side Up On package Keep away from sunlight On package Transportation and storage humidity limitation On package Transportation and storage atmospheric On package...
  • Page 13: Introduction - The Pcd-52™ System

    User Manual: PCD-52™ 737A 1. Introduction - The PCD-52™ System The PCD-52™ system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", and edemas caused by trauma and immobility. The PCD-52™...
  • Page 14: How It Works

    User Manual: PCD-52™ 737A 1.1. How it Works The PCD-52™ console supplies air at regulated pressure to the compression garment. The compression garment is fastened around the area to be treated. Compression is applied alternately with deflation and intermission to the treated area.
  • Page 15: Additional Treatments

    User Manual: PCD-52™ 737A 1.1.3. Additional Treatments 1.1.3.1. Pretherapy™ Pretherapy can be added to the beginning of the Sequential or Peristaltic cycles. Pretherapy treats the proximal areas first, decongesting them so that they can receive the lymph fluid that is mobilized during the Sequential or Peristaltic cycles. A specific pattern is applied, and the duration will vary according to garment size, lasting between 5-12 minutes, with a preselected pressure of 30 mmHg.
  • Page 16: System Components

    User Manual: PCD-52™ 737A 2. System Components The system consists of the console, compression garment(s), and hoses that deliver the air from the console to the garment. 2.1. Console and Accessories Table 1 - Console and Accessories Component Illustration The Console supplies air to the compression garments. There are two air outlets on the front of the unit.
  • Page 17: Compression Garments

    User Manual: PCD-52™ 737A 2.2. Compression Garments Your Lympha Press® dealer will select the appropriate size and type of compression garment for you, according to your physician's instructions. Some garments have pressure limitations, which are indicated in the garment instructions for use packed with the garment. Caution: If your physician prescribes pressures higher than the limits for your garment, consult your Lympha Press®...
  • Page 18: Setting Up The System

    User Manual: PCD-52™ 737A 3. Setting up the System Before using the PCD-52™ system for the first time, arrange the treatment area so that the patient can reach the console at any time during treatment. 3.1. Setting up the Console Caution: When the system has been stored in extreme temperature conditions of -20°C (-4°F) or 70°C (158°F) between uses, wait for...
  • Page 19: Attaching The Hose Bundle To The Console

    User Manual: PCD-52™ 737A 3.4. Attaching the Hose Bundle to the Console Note: Hold the console handle with one hand while connecting or disconnecting the hose bundle with your other hand. 1. Locate the hose bundle connector at the other end of the hose bundle.
  • Page 20: Operating Pcd-52

    User Manual: PCD-52™ 737A 4. Operating PCD-52™ Following is a description of the console operating panel and the various settings and displays (see Figure 1). Read this section before operating the console for the first time. Mode Button Start/Stop Button Up Button Display Screen Down Button...
  • Page 21: The Console Display Screen

    User Manual: PCD-52™ 737A 4.2. The Console Display Screen 4.2.1. Home Screen Table 3 - Home and Treatment Screen Displayed Screen Function  HOME screen - Displays pressure setting at the most distal pressure zone.  Pressure may be increased or decreased from this home screen (see instructions, below).
  • Page 22: Treatment Parameters Screens

    User Manual: PCD-52™ 737A 4.2.3. Treatment Parameters Screens Table 5 - Treatment Parameters Screens Displayed Screen Function Cycle Mode settings screen. The selected mode is displayed. Pressure Settings screen. The selected pressures in each of the four zones are displayed. Treatment Time screen.
  • Page 23: Advanced Settings Screens

    User Manual: PCD-52™ 737A 4.2.4. Advanced Settings Screens Table 6 - Advanced Settings Screens Displayed Screen Function Additions to main treatment - see Chapter 5 - Step b:  PRE - Adds Pretherapy to the beginning of treatment  POST - Adds Post-therapy to the end of treatment ...
  • Page 24: Setting Treatment Parameters

    User Manual: PCD-52™ 737A 5. Setting Treatment Parameters Note: Select treatment parameters according to your physician’s instructions. The treatment parameters selection screens are accessed by pressing To return to the HOME screen at any time, press To proceed to the next parameter selection screen, press Some screens require pressing to access a secondary menu.
  • Page 25 User Manual: PCD-52™ 737A 4. Press The Pressure Settings screen is displayed with the cursor (in black) at zone #1 (the most distal zone or chamber - over the hand or foot): 5. Press to change the pressure in zone #1. 6.
  • Page 26 User Manual: PCD-52™ 737A 9. Press to exit the pressure setting screen. You will be returned to the HOME screen. Alternative method for setting pressure:  Before beginning treatment: On the HOME screen, press , to set pressure in all chambers according to the preset gradient.
  • Page 27 User Manual: PCD-52™ 737A 12. Press again. The following screen is displayed: a. To access the Advanced Settings, press The Add-ons screen is displayed: This screen allows you to select additional therapies which are incorporated into the total treatment time. b.
  • Page 28 User Manual: PCD-52™ 737A Applies the selected treatment cycle (sequential or peristaltic) without Pretherapy™ or Post-therapy™ modes. c. Press if Post-therapy™ is to be used. This brings you to the Post Focus Area screen, where you will select the zones for Post-therapy™...
  • Page 29 User Manual: PCD-52™ 737A e. Press to access additional Advanced Settings or press to exit. f. The next Advanced Setting is Pause Time. The following screen is displayed: g. Press to increase or decrease the Pause Time. Note: Pause time is the duration between compression cycles and can be set between 10–70 seconds.
  • Page 30 User Manual: PCD-52™ 737A j. Press . This brings you to the Lock screen. The following screen is displayed: Note: In Lock state, the pressure can be lowered while treatment is running, but not increased. Other parameters cannot be changed. When the console is powered Off and then On, the pressure setting will revert to the programmed pressure.
  • Page 31: Starting The Treatment Session

    User Manual: PCD-52™ 737A 6. Starting the Treatment Session Now you are ready to operate the console and begin your treatment. Note: Hold the console handle with one hand while turning On / Off the Power Switch with your other hand. 1.
  • Page 32: Ending The Treatment Session

    User Manual: PCD-52™ 737A 7. Ending the Treatment Session 1. When the treatment time is complete, treatment stops. Turn Off the Power Switch. 2. Wait up to 30 seconds to allow the garment to deflate before you remove it. Caution: Stop treatment and consult your physician if there is onset of pain, bruising or irritation during or after treatment.
  • Page 33: Maintenance And Storage

    User Manual: PCD-52™ 737A 8. Maintenance and Storage 8.1. Cleaning the Console 1. Ensure the power cord is unplugged before cleaning the console. 2. Wipe clean using a slightly damp cloth. 3. Do not allow any moisture or liquids to enter the console! 8.2.
  • Page 34: Storage

    User Manual: PCD-52™ 737A 8.3. Storage Follow the storage instructions listed below: 1. Keep the console, all components, and garments away from direct sunlight. 2. Store in a dry, shaded place (see caution below). 3. Do not twist or fold the hose bundle. 4.
  • Page 35: Troubleshooting

    User Manual: PCD-52™ 737A 9. Troubleshooting Table 7 - Troubleshooting Symptom Possible Cause Corrective Action No electricity Check the electrical wall outlet and make sure the power cord is connected to the console. DC power adapter Verify that the DC power adapter is The console is not connected to the DC adapter socket on working.
  • Page 36: Repairs And Technical Support

    Kibbutz Afek, 3004200 Israel 9.3. Manufacturer Warranty Mego Afek AC Ltd. warrants the PCD-52™ console and compression garments to be free of defects in materials and workmanship. This warranty applies as follows:  Console: for a period of one year from the date of purchase.
  • Page 37: Appendix I - Specifications

    User Manual: PCD-52™ 737A Appendix I - Specifications Model: 737A, appliance coupler, transportable, rated: 100-240 VAC, 50-60 Hz Type of protection against electric shock Class II Degree of protection against electric shock Type BF Degree of protection against ingress of water IP21 Degree of safety of application in the Equipment not suitable for use in the presence presence of a flammable anesthetic mixture...
  • Page 38: Appendix Ii - Emc Manufacturer's Declarations

    User Manual: PCD-52™ 737A Appendix II - EMC Manufacturer's Declarations Electromagnetic Compatibility (EMC) Statement for Home Healthcare Environment The PCD-52™ system has been evaluated to international standard IEC 60601-1-2 "General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests".
  • Page 39 User Manual: PCD-52™ 737A Model 737A - electroma gnetic emissions – manufacturer’s declaration The Model 737A is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 737A should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance...
  • Page 40 User Manual: PCD-52™ 737A Model 737A - electroma gnetic immunity - manufacturer's declaration The Model 737A is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 737A should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...

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