Lumex Syatems 763400A Introduction, General Information, Intended Use, For US and Canada only

1. Introduction

This manual should be used for initial set up of the system and for reference purposes.

1.1 General Information

LumexAir systems use most advanced technologies and mattress materials to deliver the best quality, comfort and whisper-quiet operations to you and your customers. Most systems in LumexAir are recommended for prevention and treatment of pressure ulcers up to and including stage IV pressure ulcers.

This LumexAir range of system has been independently tested and successfully approved to the following standards:

EN60601-1 / UL 60601-1

EN 60601-1-2

IEC 61000-4-2

IEC 61000-4-3

IEC 61000-4-4

IEC 61000-4-5

IEC 61000-4-6

IEC 61000-4-8

IEC 61000-4-11

EN55011 CLASS B

EN 61000-3-2

EN 61000-3-3

FOR US AND CANADA ONLY

E228589

53DG

Medical Equipment-Air Pump

with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1

1.2 Intended Use

The system is a true low air loss replacement system suitable for high-risk patients. It is non- alternating mattress designed with very low average pressure dispersion. The pulsation function on the compact pump unit provides patients the message action to stimulate the blood circulation and reduce the edema.

NOTE : Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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