Moretti LEM LTM500 - Codes; Ec Declaration of Conformity; Intended Use; Introduction

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ENGLISH

I Class Medical Device

according to Directive 93/42/EEC and further modiﬁcations

CODES

LTM500 2-outlet pump for half leg or half arm garments

LTM503 3-outlet pump for full leg or full arm garments

INTRODUCTION

Thank you for purchasing a LEM compressor therapy by Moretti S.p.A. product range. This user's

manual provides some suggestions as how to correctly use the product you have chosen and gives

some valuable advice for your safety. Please read through the manual carefully before using the

product. Should you have any queries, please contact your retailer for advice and assistance.

In case of doubts, we recommend to contact the dealer who can help and advice you properly.

INTENDED USE

The compression therapy is intended for patients who need lymphatic drainage to the limbs.

EC DECLARATION OF CONFORMITY

Moretti S.p.A. hereby declares, under its own exclusive responsibility, that the products manufactured

and sold by Moretti S.p.A. and belonging to the kit pump and mattress category are in compliance with

the applicable provisions outlined in the Medical Devices Directive 93/42/EEC and further modiﬁcations.

To this end Moretti S.p.A. guarantees and declares as follows, under its own responsibility:

1. The devices in question satisfy the essential requirements of Annex I of directive 93/42/ EEC as

prescribed by Annex VII of the above directive

2. The devices in question ARE NOT MEASUREMENT DEVICES

3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION

4. The devices in question are sold in NON STERILE packing

5. The devices in question should be considered as belonging to class I

6. DO NOT use/install the devices in question for any other purpose than that expressly indicated by

Moretti S.p.A.

7. Moretti S.p.A. maintains and submits the documentation certifying conformity with Directive

93/42/EEC to the proper authorities and further modiﬁcations

CAUTION!

The compression therapy is a medical device, do not use without a physician

opinion in case of health problems.

• Do not use the product for a purpose not indicated in this manual

• Moretti S.p.A declines all responsibilities for any consequences resulting from

an incorrect use of this product and from unauthorized alteration to the frame

of the product.

• The manufacturer reserves the right to change the information contained in this

document without previous notice.

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