Gima NEW OSTEOMAT MATTRESS for magnetotherapy User guide

USER MANUAL

MNPG75-05 Edition 04/07/2022

Mat for magnetotherapy

OSTEOMAT

I.A.C.E.R. Srl

www.itechmedicaldivision.com

I.A.C.E.R. Srl

Via Enzo Ferrari, 2 – 30037

Scorzè (VE) ITALY

Ph. [phone] – Fax [phone]

e-mail: [e-mail]

http://www.itechmedicaldivision.com

T able of contents

Table of contents ........................................................................................................................................................................... 3

Introduction .................................................................................................................................................................................. 4

Technic al data............................................................................................................................................................................. 5

Te chni cal sp e cifi cat ions : ................................................................................................................................................................. 5

Instructions for use......................................................................................................................................................................... 6

I ns truc tions f o r usi ng Os t eomat ..................................................................................................................................................... 6

Labeling ........................................................................................................................................................................................ 6

Symbols: ....................................................................................................................................................................................... 7

How to take care of Osteomat...................................................................................................................................................... 8

Cleaning the Osteomat ................................................................................................................................................................. 8

Transport and storage................................................................................................................................................................... 8

Information for disposal ................................................................................................................................................................ 9

Support ......................................................................................................................................................................................... 9

Warranty ...................................................................................................................................................................................... 9

Incident reporting .......................................................................................................................................................................... 9

I.A.C.E.R. Srl 3 MNPG75-04

Introduction

The OSTEOMAT mat is the new mat for low-frequency magnetotherapy. This mat has been designed

due to the need to treat several parts of the body at the same time for prolonged therapy times.

The effectiveness of magnetotherapy in recovering from physiological conditions caused by imbalance
of cellular structures is now well known. The pulsed magnetic fields, in fact, act on cell membranes
promoting ion exchange between the two sides of the membrane. This leads to restoring the correct

transmembrane potential that is essential to ensure the supply of nutrients to the cell.

At the level of organs and anatomical structures these effects translate into analgesia, reduction of

inflammation, promotion of oedema reabsorption.

In addition, low-frequency magnetotherapy is particularly suitable for supporting the regeneration of

fractures and for slowing down the process of decrease in bone density triggered by osteoporosis.

Osteoporosis, which has now become an increasing social pheno menon, implies the need to intervene
on the skeletal architecture as a whole. In this regard, the possibility of using a mat allows you to

intervene in a systemic way on the whole body.

Therefore, th e new OSTEOMAT mat represents the ideal tool for treating multiple body segments in a

single session thanks to its great ease of use and utmost flexibility.

The device is classified as class I, in accordance with rule 1 (4.1) referred to in Annex VIII of Regulation
(EU) 2017/ 745 o f th e Europ ean Pa rliament and of the Council, dated 5 April 2017, relating to medical

devices.
Basic UDI-DI : 8019781PEM FLF MATPX
UDI-DI : 08019781112507

I.A.C.E.R. Srl 4 MNPG75-04

Technical

data

Technical speci f i cat i ons:

• Co mplete mat size: 160x65x 2 cm ;

• 4 active sectors;

• 2 connection cables;

• Compatible with MAG2000 models and LaMagneto models;

• Non-woven ma t cover (2 pieces).

The Osteomat mat consists of 4 active sectors, containing 2 solenoids each, for a total of 8.

Attention: it is advisable to put the non-wo ve n cover o nto the m at befo re use.
Osteomat has been designed to stimulate those areas of the body (shoulders, spine, pelvis) that are

most affected by a reduction in bone mass, which is a typical symptom of osteoporosis.

Refer to the following picture for the arrangement of the solenoids (indicated by the circles) inside the

Osteomat.

Place the body with your shoulders on section 1 and your legs on section 4.
The therapeutic side corresponds to that shown in the picture below:

I.A.C.E.R. Srl 5 MNPG75-04

Lab el 1

Therapeutic side with cables

coming out of the mat

Instructions for using Osteomat

To use the Osteomat mat, simply follow the simple steps below:

Instructions for use

1. Connect the two mat cables to the two CH1 and CH2 sockets located on the small panel in
the upper part of the device used (device from MAG2000 family or LaMagneto family);

2. Start the program chosen by following the specific instructions given in the user manual of
the device;

3. Position yourself on the mat, paying attention to lie down on the side indicated as

therapeutic by the specific label (the side where the connection cables come out).

Follow the Instructions given in the user manuals of the products of the MAG2000 or LaMagneto

series.

Labeling

I.A.C.E.R. Srl 6 MNPG75-04

Symbol

Meaning

Label 1

YYYY-MM

Month

Year

Symbols:

Manufacturer's logo.

In compliance with regulation (EU) no. 2017/745

Manufacture r data.

Date of manuf acture (YYYY-MM).

Medical device

Follow the instructions for use.

WEEE directive for the disp osal of ele ctronic wast e.

I.A.C.E.R. Srl 7 MNPG75-04

Symbol

Meaning

Type BF applied part.

Allowed temperatures (storage temperatures, on packaging).

Re lative hum idity (re lativ e hu midity of s torage, on packaging ).

Pay attention, danger.

Do not dry.

Do not iron.

Do not wash.

How to take care of

Osteomat

Cleaning the Osteomat

To clean the Osteomat it is recommended to disconnect the mat from the device before carrying out
any operation. Clean the fabric with a cloth dampened with simple water and neutral soap and wait

for it to dry completely before reusing the mat for a therapy session.

Transpor t a nd st or age

There are no special care instructions for transport. For storage, the equipment is protected up to the

following environmental conditions:

room temperature from +5 to + 40 °C
relative humidity from 15 t o 93%

I.A.C.E.R. Srl 8 MNPG75-04

Information for disposal

The produc t is s ubjec t to the WE EE legislation (pres enc e on the label of the s ymbol)
relating to s epar ate was t e collec t ion: to dis pos e of t he produc t, us e s pec ial areas equipped
for the collection of electronic material by contacting the competent authorities of your country
or the manufacturer directly.

Support

The manufacturer is the sole entity authorized to provide technical support for the Osteomat

therapeutic mat. Should you need technical support, please contact:

I.A.C.E.R. S.r.l.

Via Enzo Ferrari, 2 • 30037 Scorzè (VE)

Ph . 041. 5401356 • Fax [phone]

Warranty

Osteomat is covered by a 2-year warranty starting from the date of purchase. The warranty shall lapse in case of tampering,
neglect and inappropriate use of the mat and if any intervention is carried out by personnel not authorized by the manufacturer

or by the authorized dealer.

Incident reporting

In c omplianc e with t he prov is ions of Regulation (E U) 2017/745, the manufac tur er places the
need to report any serious accident in relation to the device to the attention of the user.

The report must be addressed:

• to the device manufacturer:

I.A.C.E.R. Srl

Via Enzo Ferrari 2 – 30037

Scorzè (VE) ITALY

Tel. [phone] – Fax [phone]

e-mail: [e-mail]

I.A.C.E.R. Srl 9 MNPG75-04

OSTEOMAT. All rights reserved. OSTEOMAT and the logo are the exclusive property of I. A.C.E.R. Srl and are registered trademarks

I.A.C.E.R. Srl 10 MNPG75-04