Lympha Press PCD-52 Model 737A User Manual

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. Introduction - The PCD-52™ System ...1 1.1. How it Works ... 2 1.1.1. The Sequential Mode ... 2 1.1.2. The Peristaltic Mode ... 2 1.1.3. Additional Treatments ... 3 1.1.3.1. Pretherapy™ ... 3 1.1.3.2. Post-therapy™ ... 3

1.2. Calibrated Gradient Pressure ... 3 1.3. Treatment Garments... 3 2. System Components ...4 2.1. Console and Accessories ... 4 2.2. Compression Garments ... 5 3. Setting up the System ...6 3.1. Setting up the Console ... 6 3.2. Preparing for Treatment ... 6 3.3. Putting on the Compression Garment ... 6 3.4. Attaching the Hose Bundle to the Console ... 7 4. Operating PCD-52™ ...8 4.1. The Console Controls ... 8 4.2. The Console Display Screen... 9 4.2.1. Home Screen ... 9 4.2.2. Status Icons ... 9 4.2.3. Treatment Parameters Screens ... 10 4.2.4. Advanced Settings Screens... 11

5. Setting Treatment Parameters ... 12 6. Starting the Treatment Session ... 19 7. Ending the Treatment Session ... 20 L98005H1-F

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8. Maintenance and Storage ... 21 8.1. Cleaning the Console ... 21 8.2. Cleaning the Compression Garment... 21 8.3. Storage ... 22 8.4. Travel ... 22 8.5. Disposal ... 22 9. Troubleshooting ... 23 9.1. Repairs and Technical Support ... 24 How to Contact Us ... 24

9.1.1. Distributor in USA ... 24 9.1.2. Authorized Lympha Press® Service Center ... 24

9.2. Manufacturer ... 24 9.3. Manufacturer Warranty ... 24 9.4. PCD-52™ Service Life ... 24 Appendix I - Specifications ... 25

Appendix II - EMC Manufacturer's Declarations ... 26

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. ii

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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.

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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 • Post mastectomy edema • Edema following trauma and sports issues • Post immobilization edema • Reduction of wound healing time • Reduction of pain and swelling after injury and surgery The device is intended for hospital, home, and clinic use.

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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 Acute infection of the affected limb Decompensated cardiac failure Severe arteriosclerosis or other ischemic vascular disease Any circumstance where increased venous and lymphatic return is undesirable • Within one month of skin grafting or vascular bypass in the affected area • Known or suspected compartment syndrome Exercise caution when using on patients with insensitive extremities. • • • • • •

Due to movement of fluids in the body when using the device, exercise caution when using on patients with heart disease. High pressure is not recommended for patients who have peripheral occlusion disease. The abdominal area should not be treated during pregnancy. Caution: Federal law (USA) restricts this device to sale and use by, or on the order of, a physician.

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.

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Warning: Indicates a situation in which the operator or the patient may be in danger of injury or death.

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Safety Warnings and Precautions

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Warning: Explosion Hazard Do not use the PCD-52™ system in the presence of flammable gases, including flammable anesthetics.

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Warning: Electric Shock Hazard Do not allow liquid to enter any part of the PCD-52™ console. Do not immerse. To clean, follow instructions given in Section 8.1 - Cleaning the Console.

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Warning: Electric Shock Hazard To prevent electric shock, do not open the console. Do not attempt to service the console yourself. All maintenance tasks should be performed only by Lympha Press® trained and authorized service personnel. Service by unauthorized personnel shall void any warranty.

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Warning: Do not attempt to clean the console while it is operating. Unplug from mains power before cleaning.

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Warning: Do not use the PCD-52™ system if you notice a change in operating system performance, the system is damaged, or any of its components are worn or frayed.

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Warning: Do not modify any part of the PCD-52™ system.

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Warning: MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment.

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Warning: The equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it is used. L98005H1-F

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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). Caution: Do not use the PCD-52™ system beyond the specified humidity range: 30%rH–75%rH, non-condensing. Caution: Use the PCD-52™ system up to 3000m above mean sea level. Caution: To prevent any damage to the PCD-52™ system, keep it away from dust, lint, and dirt. Keep away from sources of heat or moisture. Keep away from pets. Caution: To prevent any damage to equipment, use only accessories, detachable parts and materials described in this user manual. Caution: While in use, place the console on a horizontal firm surface only. Do not place the console on bed, blanket, mattress, pillow, or soft furniture. Do not cover the console. Caution: The equipment is to be installed and put into service according to the EMC information provided in Appendix II. Caution: Portable and mobile RF communication equipment might affect the equipment.

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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

Level of protection type BF applied part

On console base

Double insulation

On DC power adapter

Direct current

On console base

MR Unsafe - keep away from Magnetic Resonance Imaging (MRI) equipment

On console base

Manufacturer's name and address

On garment label and on console base

Date of Manufacture

On console base

Unique Device Identification (UDI)

On console base and package, and garment bag and package

Separate collection for waste electrical and electronic equipment. Note: For more information about disposal of equipment, parts and accessories, please contact your local distributor.

On console base

Serial number of the console

On console base

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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

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Transportation and storage atmospheric pressure limitation

On package

Transportation and storage temperature Limitation

On package

"ON" (power)

On Power Switch

"OFF" (power)

On Power Switch

Do not wash

On garment tag

Do not dry-clean

On garment tag

Do not tumble dry

On garment tag

Do not bleach

On garment tag

Do not iron

On garment tag

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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™ system consists of: • The console (sometimes called "compressor" or "pump"), which supplies air at regulated pressures to a compression garment that is worn over the area to be treated. • Hoses that transfer the air from the console to each of the chambers in the compression garment. • The compression garment, which is fastened around the area to be treated. Each garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the PCD-52™ console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete. The compress-and-release massage action of the PCD-52™ system stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

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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. PCD-52™ has two different treatment modes:  Sequential  Peristaltic Pretherapy™ and Post-therapy™ can be added to the Sequential and Peristaltic modes. These modes are described in the following sections. Note: Your physician will select the appropriate treatment mode for your condition. 1.1.1. The Sequential Mode

The sequential mode applies a directional massage that starts at the base of the treated limb (the "distal" area), over the foot or hand, and progresses upwards towards the torso until the entire area is compressed. This gradual, directional compression assists the flow of lymphatic fluid out of the swollen area and towards the lymphatic collectors in the torso. It prevents reflux ("wrong-way flow") of lymphatic fluid that could occur if distal compression is not maintained. When the compression wave reaches the top of the limb, the pressure is released for a brief intermission, allowing for lymphatic and venous refill. 1.1.2. The Peristaltic Mode

The Peristaltic mode starts at the base of the limb, over the foot or hand. As the chamber at the front of the wave inflates, the chamber at the back of the wave starts to deflate, so at any one time a small area is being compressed. Because this mode releases the air in the distal chambers as it moves up the limb, it may be selected for patients with distal discomfort.

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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. 1.1.3.2. Post-therapy™

Post-therapy can be added to the end of the Sequential or Peristaltic cycles. Post-therapy provides a "focused" treatment for either the proximal, medial or distal areas, according to user selection, and then follows it with a wave-like "sweep" over the entire treated area, according to the principles of manual lymph drainage. Post-therapy duration is 5 minutes, at the zone pressure that has been selected for the Sequential or Peristaltic cycles.

1.2. Calibrated Gradient Pressure The PCD-52™ system applies pressure as selected according to physician orders. Pressure can be selected individually at the console for four zones on the garment. A reverse gradient (in which the pressure is higher proximally) cannot be selected, as a reverse gradient can cause wrong-way flow or impede efficient treatment. The minimum pressure that can be set is 20 mmHg. The maximum pressure that can be set is 80 mmHg. Note: Pressure can be selected individually at the pump for each of the four zones, to accommodate special circumstances. The system will not permit setting a reverse gradient, which would be detrimental to the treatment process.

1.3. Treatment Garments PCD-52™ is used with Lympha Press® multi-chamber compression garments. Your physician will determine the type of garment you need.

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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. The Hose Bundles connect to these two outlets. The console can operate one or two compression garments simultaneously. Plug When using only one garment or hose, you must seal the second air outlet located on the front of the console to keep air from escaping. Use the Plug to seal the unused outlet on the front of the console. DC Power Adapter The DC power adapter receives 100-240 VAC, 50-60 Hz power and supplies 15 VDC 3A to the console. Caution:  For indoor use only.  Use only the DC power adapter provided with the PCD-52™ console.

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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® dealer. The PCD-52™ system includes the following garment types: Type 4-chamber garments

Area Treated  Arm and Shoulder  Leg

 Leg  Arm, shoulder, chest, axilla, and abdomen 8-chamber garments  Lower body treatment including abdomen, hips, buttocks, and genital area

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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 two (2) hours before using the system. 1. Place the console on a flat stable surface from where it will not slip or fall. The front of the console must be at least six inches from the edge of the surface. 2. Position the console so that the patient can easily reach the controls during treatment. 3. Plug the DC power adapter cable into the DC adapter socket on the console, and then plug the power cord into an appropriate 100-240 Volt wall outlet. Note: The console is "multi-voltage" and can be used for travel. An appropriate socket adapter must be used in countries with incompatible wall outlets.

3.2. Preparing for Treatment Always wear clothing under the compression garments, to prevent irritation and for hygienic reasons. Treatment Positions Ask your physician for specific recommendations on treatment position. Always make sure the console and hoses can be reached easily from the treatment position.

3.3. Putting on the Compression Garment The garment should not fit tightly. Follow the garment instructions for use, packed with the garment you use.

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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. Also note the two air outlets on the front of the console. 2. Insert the hose bundle connector into one of the two air outlets at the front of the console, making sure the logo Lympha Press® is facing UP. The hose connector will "click" into place. If you do not hear a click, move it gently to make sure it is secure.  To remove the hose bundle connector, press the release buttons at either side of the connector and pull out the connector.  If you are using only one garment, plug the unused air outlet at the front of the console with the Plug (you will find this in the zipper accessory bag supplied with the console). It is important to plug this outlet. If it is left open, air will escape, the console will stop working, and the alarm will beep. Note: When only one garment is used, the second outlet must be plugged. Otherwise the console will stop working, and the alarm will beep.

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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

Figure 1 - The Console Operating Panel

4.1. The Console Controls Table 2 - Console Controls Control

Function Mode button: Used to select treatment pressure, treatment time, cycle mode, pause time, and hold time. Up and Down buttons: Used to adjust treatment pressure, treatment time, cycle mode, pause time, and hold time.

START/STOP button: Used to start or stop treatment. Power Switch: Used to turn On the console (located at the bottomright backside of the console) DC Adapter Socket: Used for connecting the DC Adapter (located under the Power Switch)

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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).  Displays treatment time setting, which decreases during treatment.

4.2.2. Status Icons

The status icons are displayed at the top of the screen. Table 4 - Status Icons Displayed Icon

Function General Warning (displayed if the console detects internal problem) Air Leak (displayed when the console detects an air leak) Treatment in progress Lock (displayed if Lock ON option selected)

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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. The selected time is displayed.

Advanced Settings Screen (see Section 4.2.4).

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