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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User Manual: PCD-51™ 731A
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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User Manual: PCD-51™ 731A
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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User Manual: PCD-51™ 731A
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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User Manual: PCD-51™ 731A
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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User Manual: PCD-51™ 731A
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