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Mego Afek Phlebo Press DVT 603 User Manual

Pneumatic compression therapy system
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Phlebo Press
®
DVT
Pneumatic Compression Therapy System
Model 603
User Manual
L9810131-G

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Summary of Contents for Mego Afek Phlebo Press DVT 603

  • Page 1 Phlebo Press ® Pneumatic Compression Therapy System Model 603 User Manual L9810131-G...

  • Page 3: Table Of Contents

    User Manual: Phlebo Press DVT 603 ® Table of Contents Important - Before you Start ..............iii Indications ..................... iv Contraindications..................v Symbols used in this Manual ..............vi Safety Warnings and Precautions ............vi Labels and Symbols on the Console, Garments, and/or Packaging ..ix 1.
  • Page 4 Copyright © 2024 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. L9810131-G...

  • Page 5: Important - Before You Start

    User Manual: Phlebo Press DVT 603 ® Important - Before you Start 1. Read this entire manual before setting up and operating the Phlebo Press® DVT 603 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: Phlebo Press DVT 603 ® Indications Phlebo Press® DVT model 603 is intended for use by medical professionals and patients who are under medical supervision, in treating conditions such as: • Prevention of deep vein thrombosis (DVT) in patients who may be susceptible •...

  • Page 7: Contraindications

    User Manual: Phlebo Press DVT 603 ® Contraindications Note: Do not use Phlebo Press® DVT 603 in the presence of the following conditions: • Known or suspected deep vein thrombosis, congestive heart failure, pulmonary edema, thrombophlebitis, severe arteriosclerosis, or active infections •...

  • Page 8: Symbols Used In This Manual

    User Manual: Phlebo Press DVT 603 ® Symbols used in this Manual Symbol Description Note: Describes how the system functions or provides a note on how best to use it. Caution: Refers to the safe operation of the system and provides cautions where the possibility of loss of data or damage to the equipment exists.
  • Page 9 User Manual: Phlebo Press DVT 603 ® Warning: Do not attempt to clean the console while it is operating. Unplug from mains power before cleaning. Warning: The Phlebo Press® DVT 603 system includes small parts that can be a choking hazard for small children. Keep away from children.
  • Page 10 603 system during use by a patient. Warning: Use the Phlebo Press® DVT console only with batteries supplied with the system or supplied as replacement by Mego Afek. Note: A patient can be an intended operator of the Phlebo Press® DVT 603 system.

  • Page 11: Labels And Symbols On The Console, Garments, And/Or Packaging

    On console base On console base and console packaging label Manufacturer's name and address On garment and all Mego Afek AC Ltd. garment packaging labels Kibbutz Afek 3004200, Israel Double insulation On console base MR Unsafe - keep away from Magnetic...
  • Page 12 User Manual: Phlebo Press DVT 603 ® Label Description Location On console base and Unique Device Identification (UDI) package, and garment bag and package Separate collection for waste electrical and electronic equipment Note: On console base For more information about disposal of equipment, its parts, and accessories, please contact your local distributor.
  • Page 13 User Manual: Phlebo Press DVT 603 ® Label Description Location Keep away from sunlight On carton Transportation and storage humidity On carton limitation Transportation and storage atmospheric On carton pressure limitation Transportation and storage temperature On carton limitation Alternating Current On console base Do Not Wash On garment tag...

  • Page 15: Introduction

    User Manual: Phlebo Press DVT 603 ® 1. Introduction Phlebo Press® DVT 603 is used to help prevent deep vein thrombosis in patients who may be susceptible. It may also be used to treat conditions as listed in the Indications for Use. The massage action applied by the garments compresses the treated areas to enhance blood flow and reduce stasis.
  • Page 16 User Manual: Phlebo Press DVT 603 ® Phlebo Press® DVT 603 can be used with Sequential or Intermittent garments, or any combination of each, according to licensed medical practitioner's orders. The console recognizes the garment type automatically and applies the correct treatment sequence. ...

  • Page 17: Safety Features

    User Manual: Phlebo Press DVT 603 ® 1.2. Safety Features  Safety Over-pressure Valve (Relief Valve) The console contains an over-pressure valve to ensure that the pressure in the garments does not exceed the manufacturer's maximum pressure limit.  Power Failure In an event of mains power failure, the console operates on battery power.

  • Page 18: System Components

    User Manual: Phlebo Press DVT 603 ® 2. System Components The Phlebo Press® DVT 603 system consists of the Phlebo Press® DVT 603 console, hose bundle, and compression garments. 2.1. Console and Hose Bundle Component Illustration Press® DVT The Phlebo 603 console is powered by electricity from a wall outlet or by a rechargeable battery inside the console.
  • Page 19 User Manual: Phlebo Press DVT 603 ® Component Illustration Hose Bundle The Hose Bundle transfers compressed air from the console to the compression garments. Two types of hose bundles are available: Hose Bundle for 4-hose garments: This hose bundle consists of 4 hoses, a connector that attaches to the corresponding receptacle of the device, and a connector that attaches to the garment hoses connector.

  • Page 20: Compression Garments

    User Manual: Phlebo Press DVT 603 ® 2.2. Compression Garments The garments apply cyclic air pressure supplied by the console to the treated limb(s). Two types of garments available: multiple patient use and single use for single patient only. Garment Name Illustration Single use Calf and Foot (Sequential)
  • Page 21 User Manual: Phlebo Press DVT 603 ® Garment Name Illustration Single use single-chamber Calf (Intermittent) Single use single-chamber Foot (Intermittent) Multiple use Calf and Foot (Sequential) L9810131-G...
  • Page 22 User Manual: Phlebo Press DVT 603 ® Garment Name Illustration Multiple use Calf and Foot (Sequential) For use with Hose Bundle for 4- inlet garments Multiple use Calf (Sequential) Multiple use Calf (Sequential) For use with Hose Bundle for 4- inlet garments Single use Calf and Foot (Sequential)
  • Page 23 User Manual: Phlebo Press DVT 603 ® Garment Name Illustration Single use Calf & Thigh (Sequential) For use with Hose Bundle for 4- inlet garments Single use Calf (Sequential) For use with Hose Bundle for 4- inlet garments L9810131-G...

  • Page 24: Setting Up The System

    User Manual: Phlebo Press DVT 603 ® 3. Setting up the System Before using the Phlebo Press® DVT 603 system for the first time, arrange the treatment area so that the patient can reach the console at any time during treatment. 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 25: Putting On The Compression Garment

    User Manual: Phlebo Press DVT 603 ® 3.2. Putting on the Compression Garment Clothing (clean cotton socks, light cotton pants, or stockinet) must be worn under the multiple patient multi use compression garments, to prevent irritation and for hygienic reasons. Clothing worn underneath the compression garment should be free of buttons, zippers and decorations that may rub against the skin.
  • Page 26 User Manual: Phlebo Press DVT 603 ® 3.2.1. Calf and Foot Garment (Sequential) Use the Calf and Foot garment while lying down or in a seated position. A. Open the garment by separating the two upper flaps. B. Gently slide the garment underneath the leg to be treated. C.
  • Page 27 User Manual: Phlebo Press DVT 603 ® f. Securely insert the hose bundle connector into one of the console air outlets (it does not matter which one). Make sure the air hoses are not bent, kinked, or pinched. Garments should be removed regularly to examine the skin. Note: Do not allow patient to stand or walk while wearing the Calf and Foot Garment.
  • Page 28 User Manual: Phlebo Press DVT 603 ®  For 4-inlet Calf garment: a. Consult the Phlebo Press DVT size chart for the correct garment size. b. Open the garment by separating the two upper flaps. c. Gently slide the garment underneath the leg to be treated. d.
  • Page 29 User Manual: Phlebo Press DVT 603 ® 3.2.3. Calf & Thigh Garment (Sequential) The Calf & Thigh garment is for use while lying down. A. The garments are sided RIGHT and LEFT. Apply the garment marked RIGHT to the patient's right leg, and the garment marked LEFT to the patient's left leg.
  • Page 30 User Manual: Phlebo Press DVT 603 ®  For 4-inlet Calf & Thigh garment: a. Consult the Phlebo Press DVT size chart for the correct garment size. The garment has two sections: an upper section that wraps around the thigh, and a lower section, which is larger and wraps around the calf.
  • Page 31 User Manual: Phlebo Press DVT 603 ® 3.2.4. Single-chamber Foot Garment (Intermittent) The Single-chamber Foot garment is for use while lying down or in a seated position. When using foot garments, it is preferable for feet to be at a lower level than the heart. Caution: Before ambulation, disconnect the hose bundle from the garment and remove the garment.

  • Page 32: Operating The Console

    User Manual: Phlebo Press DVT 603 ® 4. Operating the Console Following is a description of the console operation panel and the various settings and displays. Please read this section before operating the console for the first time (see Figure 1, Table 1, and Table 2). Note: In case of power failure, the console continues to operate on battery power.
  • Page 33 User Manual: Phlebo Press DVT 603 ® Icon Function Pressure Level (mmHg) Error Number - in case of error, the pressure level display changes to the error number Connector Indicator - indicates the connector to which the currently inflated garment is connected. In case of error, indicates the connector on which the error was detected (when applicable) Connected Garment(s) - displays the connected...
  • Page 34 User Manual: Phlebo Press DVT 603 ® 4.1. Treatment Procedure Description 1. At the beginning of the treatment, after the user presses the Start/Stop Button, the console performs a short scanning process to detect the type of garment connected to each outlet (leg garment, foot garment, sequential or intermittent), and also detects if two garments are in use, or one garment only.

  • Page 35: Maintenance

    User Manual: Phlebo Press DVT 603 ® 5. Maintenance 5.1. Console cleaning and disinfecting Caution: 1. Wear protective gloves during Console cleaning and disinfecting. 2. Wash your hands thoroughly after cleaning and disinfecting. 1. Ensure the power cord is unplugged before cleaning the console. 2.

  • Page 36: Storage And Transportation

    User Manual: Phlebo Press DVT 603 ® Note: Single use garments are not to be cleaned. Be sure to dispose of the garments properly after each use. Caution:  Do not hand or machine wash. Surface wipe only!  Do not allow liquid to get into the air inlets or hoses. ...

  • Page 37: Disposal

    5.6. Replacing the Battery Note: Use only batteries supplied by Mego Afek AC Ltd. To replace the battery: 1. Open the battery compartment cover, located at the bottom front side of the console (see figure below).

  • Page 38: Troubleshooting

    User Manual: Phlebo Press DVT 603 ® 6. Troubleshooting Note: Before continuing, inspect all accessories for any defects. Table 3 - Troubleshooting Guide Symptom Possible Cause Corrective Action No electricity Inspect the electrical wall outlet. The console is not working. Power cord Inspect the power cord for any defects.
  • Page 39 User Manual: Phlebo Press DVT 603 ® Symptom Possible Cause Corrective Action The console stops working, Status Indicator is red, the buzzer sounds, the General Internal Contact your local distributor for service. Warning icon flashes, and problem E3, E4, E5, E7, or E8 is displayed.

  • Page 40: Repairs And Technical Support

    User Manual: Phlebo Press DVT 603 ® 6.1. Repairs and Technical Support Contact your local distributor for repairs and/or technical support. 6.2. Manufacturer Mego Afek AC Ltd. Kibbutz Afek 3004200 Israel Tel: 972-77-9084277 E-mail: info@megoafek.com Web: www.megoafek.com 7. Phlebo Press® DVT 603 Service Life When used and maintained as instructed, the expected service life of the Phlebo Press®...

  • Page 41: Appendix I - Specifications

    User Manual: Phlebo Press DVT 603 ® Appendix I - Specifications Pressure Power Dimensions Model Class Voltage Freq. Fuses Range Consumption & Weight 227 x 197 x 90-264 VAC 176 mm 45 mmHg Internal (8.93" x 7.75" and/or 47-63Hz 40 VA battery: x 6.92") 130 mmHg...

  • Page 42: Appendix Ii - Emc Manufacturer's Declarations

    User Manual: Phlebo Press DVT 603 ® Appendix II - EMC Manufacturer’s Declarations Warning: 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.
  • Page 43 User Manual: Phlebo Press DVT 603 ® Table 5 - Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electrostatic discharge ±8 kV contact ±8 kV contact (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15 kV air IEC 61000-4-2 Electrical fast...
  • Page 44 User Manual: Phlebo Press DVT 603 ® Table 7 - Immunity to Proximity Fields from RF Wireless Communications Equipment IEC 60601 Test Level Immunity Test Compliance Level Maximum Immunity Test Frequency Modulation Power Level Radiated RF 385 MHz **Pulse Modulation: 18Hz 1.8W 27 V/m 27 V/m...

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