Lympha Press PCD-51 731A User manual

PCD-51™
Model 731A
Sequential Compression Therapy System
User Manual
L98005G3-EU-A

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User Manual: PCD-51™ 731A
Table of Contents
Important - Before You Start..................................................................iii
Indications .............................................................................................iv
Contraindications...................................................................................iv
Symbols used in this Manual ..................................................................v
Safety Warnings and Precautions ...........................................................v
Labels and Symbols on the Console, Garments, and/or Packaging....... viii
1. Introduction - The PCD-51™ System .................................................1
2. System Components.........................................................................2
2.1. Console and Accessories ................................................................2
2.2. Compression Garments..................................................................3
3. Setting up the System ......................................................................4
3.1. Setting up the Console ...................................................................4
3.2. Preparing for Treatment ................................................................5
3.3. Putting on the Compression Garment............................................5
3.4. Attaching the Hose Bundle to the Console.....................................6
4. Operating PCD-51™ ..........................................................................7
The Console Controls...............................................................................7
5. Setting Treatment Pressure and Time ..............................................8
6. Starting the Treatment Session ........................................................9
7. Ending the Treatment Session ..........................................................9
8. Maintenance & Storage..................................................................10
8.1. Cleaning the Console....................................................................10
8.2. Cleaning the Compression Garment.............................................10
8.3. Storage.........................................................................................11
8.4. Travel ...........................................................................................11
8.5. Disposal........................................................................................11
9. Troubleshooting .............................................................................12
9.1. Repairs and Technical Support.....................................................13
9.2. Authorized Representative in Europe ..........................................13
9.3. Manufacturer...............................................................................13
9.4. Manufacturer Warranty...............................................................13
9.5. PCD-51™ Service Life....................................................................13

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Appendix I - Specifications....................................................................14
Appendix II - EMC Manufacturer's Declarations....................................15
Copyright © 2020 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.

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Important - Before You Start
1. Read this entire manual before setting up and operating the
PCD-51™ 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
•Primary lymphedema
•Secondary lymphedema
•Venous insufficiency
•Venous stasis ulcers
•Dysfunction of the muscle pump
PCD-51™ is intended for use by patients at home, and by medical
practitioners in clinics.
PCD-51™ is intended for use by patients above age of 12 years old and
above weight of 30 kg.
Contraindications
Use of the PCD-51™ system is not recommended in the presence of one
or more of the following conditions:
•Known or suspected deep vein thrombosis 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
Due to movement of fluids in the body when using the system, be careful
with patients that have heart disease. Using high pressure is not
recommended for patients having peripheral occlusion disease.
Caution:
This device is for sale and use by, or on the order of, a licensed
medical practitioner.

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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.
Warning: Indicates a situation in which the operator or the
patient may be in danger of injury or death.
Safety Warnings and Precautions
Warning: Electric Shock Hazard
Do not allow liquid to enter any part of the PCD-51™ console.
Do not immerse. To clean, follow instructions given in Sections
8.1 and 8.2 of this User Manual.
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 trained and authorized service
personnel. Service by unauthorized personnel shall void any
warranty.
Warning:
Do not attempt to clean the console while it is operating.
Unplug from mains power before cleaning.
Warning:
Do not use PCD-51™ in the presence of flammable material.
Warning: Keep Dry!
Do not immerse in liquid or allow liquid to enter any part of the
PCD-51™ system.
Do not use PCD-51™, any parts thereof, or any accessories if
they have become wet or exposed to liquids.
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Warning:
Do not modify any part of the PCD-51™ system.
Warning:
Do not service or maintain any part of the PCD-51™ system
during use by a patient.
Warning:
Connect to the PCD-51™ console only parts of the PCD-51™
system.
Warning:
Stop treatment in case of any change of the PCD-51™ system
performance.
Warning:
The PCD-51™ system includes small parts. To avoid choking, do
not swallow, and keep away from children.
Caution:
To prevent any damage to the PCD-51™ system, keep it away
from dust, lint, and dirt. Keep away from sources of heat or
moisture. Keep away from pets.
Caution:
Do not use the PCD-51™ system beyond the specified
temperature range: 10 to 30°C (50 to 86°F).
Caution:
Do not use the PCD-51™ system beyond the specified humidity
range: 30%rH–75%rH, non-condensing.
Caution:
Do not store or transport the PCD-51™ system beyond the
specified temperature range (see Section 8.3 - Storage).
Caution:
Do not operate the PCD-51™ system during transit.
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Caution:
Use the PCD-51™ system up to 3000m above mean sea level.
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 horizontal firm surface only.
Do not place the console on bed, blanket, mattress, pillow, or
soft furniture. Do not cover the console.
Caution:
Disconnect the console from electrical outlet before cleaning.
Let it dry completely before reconnecting it to the electrical
outlet.
Note:
Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient
is established.

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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, its parts and accessories, please
contact your local distributor.
On console base

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Symbol Description Location
CE label showing compliance with European
Directive 2007/47/EC amending Directive
93/42/EEC, concerning medical devices
On console base
Serial number of the console 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 humidity limitation On package
Transportation atmospheric pressure
limitation On package
Transportation 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-51™ System
The PCD-51™ system is a sequential pneumatic compression therapy
system for treatment and management of lymphedema, venous
insufficiency, venous stasis ulcers and dysfunction of the "muscle pump".
The PCD-51™ system consists of:
•The console (sometimes called "compressor" or "pump"). It supplies
air at regulated pressure to a compression garment that is worn
around the area to be treated. The PCD-51™ console is powered by a
DC power adapter that is to be plugged into a suitable 100-240V
power outlet.
•Hoses that transfer the air from the console to each of the chambers
in the compression garment
•The compression garment(sometimes called a "sleeve"), which is
fastened around the area to be treated.
Each garment contains 4 or 8 overlapping air chambers. These chambers
are filled with air from the console in sequence, applying a compressive
massage. Once the entire area has been compressed, the PCD-51™
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-51™ 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 lymphatic vessels and
return to the blood circulation. The directional compressive massage also
helps reduce venous edema and stimulates venous return.

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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
If using one garment only, 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 12 VDC 3A to the console.
Caution:
For indoor use only.
Use only the DC power adapter provided
with the console.

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2.2. Compression Garments
Your distributor will select the appropriate size and type of garment
for you, according to your licensed medical practitioner's instructions.
Some garments have pressure limitations, which are indicated in the
garment instructions for use packed with the garment.
Caution:
If your licensed medical practitioner prescribes pressures higher
than the limits for your garment, consult your distributor.
The PCD-51™ system includes the following garment types:
Type Area Treated
4-chamber garments Arm and Shoulder
Leg
8-chamber garments
Leg
Arm, shoulder, chest, axilla, and abdomen
Lower body treatment including abdomen,
hips, buttocks, and genital area

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3. Setting up the System
Before using the PCD-51™ 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
two (2) hours before using the system.
3.1. Setting up the Console
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. Select the plug suitable for your country and insert it onto the pins
on the DC adapter backside (see figure below).
To replace the plug, press and hold the Open button under the plug
while pulling out the plug (see figures below).

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4. Insert the DC power adapter cable into the DC adapter socket on
the console, and then insert the DC adapter 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 garment, to prevent
irritation and for hygienic reasons.
Treatment Positions
Ask your licensed medical practitioner 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®
faces UP. The hose bundle connector "clicks" 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 use only one garment, plug the unused air outlet at the
front of the console with the Plug (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 stops working and the alarm
beeps.

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4. Operating PCD-51™
Following is a description of the console operating panel. Read this
section before operating the console for the first time.
Figure 1 - The Console Operating Panel
The Console Controls
Table 2 - Console Controls
Control Function
Time Knob: Used to set treatment time (15–90 min.)
Lock Knob: Disables turning the Pressure Knob to prevent
unintentional change of pressure setting.
Pressure Knob: Used to set treatment pressure (20–80 mmHg).
Status Indicator:
White - power is On. Treatment has not started
Green - treatment is in progress
Orange - indicates malfunction (see Chapter 9 -
Troubleshooting).
Pressure Knob
Time Knob
Start/Stop Button
Lock Knob
Status Indicator

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Control Function
Start/Stop Button:Used to start or stop treatment.
Power Switch: Used to turn On the console (located at the
bottom-right backside of the console)
DC Adapter Socket: Used for connecting the DC power adapter
(located under the Power Switch)
5. Setting Treatment Pressure and Time
Note:
Select treatment pressure and time according to your licensed
medical practitioner's instructions.
1. Turn the Lock Knob counterclockwise to release the Pressure Knob.
2. Set the Pressure Knob to the required treatment pressure.
The minimum pressure setting is 20 mmHg.
The maximum pressure setting is 80 mmHg.
3. Turn the Lock Knob clockwise to lock the Pressure Knob.
4. Set the Time Knob to the required treatment time.
The minimum treatment time setting is 15 minutes.
The maximum treatment time setting is 90 minutes.

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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. Ensure that all hoses are properly connected to the garment and that
the hose bundle is securely attached to the console.
2. Verify that the Power Switch at the back of the console is in the OFF
position.
3. Connect the DC power adapter cable to the DC adapter socket
(located under the Power Switch).
4. Connect the DC power adapter to the electrical outlet.
5. Get into a comfortable seated, reclining, or lying position from where
you can easily reach the console controls. Put on the garment,
following the directions in Section 3.3 above.
6. Turn the Power Switch to the ON position.
7. Press .
Treatment begins.
Note:
At the start of treatment, the garment may take several inflation
cycles to fill completely, as the garment must be filled from a
completely empty state.
7. Ending the Treatment Session
1. When your treatment time is complete, treatment stops.
If you need to stop treatment in the middle, press .
At the end of treatment, turn OFF the Power Switch.
2. When treatment stops, wait up to 30 seconds to allow the garment to
deflate before you remove it.
Note:
When immediate garment deflation is necessary, disconnect the
hose bundle from the console to immediately deflate the air
pressure in the garment.