I-Tech I-Press Bedienungsanleitung

USER MANUAL

Pressotherapy

Table of contents

TABLE OF CONTENTS I

TECHNICAL INFORMATION 3

MANUFACTURER 3

DECLARATION OF CONFORMITY 3

CLASSIFICATIONS 4

INTENDED PURPOSE AND SCOPE OF USE 4

TECHNICAL SPECIFICATIONS 5

DEVICE DESCRIPTION AND CONTROLS 6

LABELLING 7

Pack contents 9

HOW TO USE THE DEVICE 10

INTRODUCTION TO THE TECHNOLOGY 10

CONTRAINDICATIONS 10

WARNINGS 11

PATIENT PREPARATION 12

USE OF DEVICE 14

RECOMMENDED THERAPY SETTINGS 16

LOOKING AFTER FOR THE DEVICE 17

MAINTENANCE 17

TROUBLESHOOTING 18

DISPOSAL INFORMATION 19

WARRANTY 20

Support 21

Spare parts 21

INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES 22

IACER Srl 3 MNPG338-00

Technical information

Manufacturer

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

Via S. Pertini, 24/a • 30030 Martellago (VE)

Tel.: +39 041.5401356 • Fax: +39 041.5402684

IACER S.r.l. is an Italian manufacturer of medical devices (CE certificate No.

HD60134521 issued by the Notified Body No. 1936 TÜV Rheinland Italia srl).

Declaration of conformity

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

Via S.Pertini 24/A – 30030 Martellago (Ve), Italy

declares under its own responsibility that the product

I-PRESS

UMDNS code: 10969

is designed and built in compliance with the essential requirements of

Annex 1 of Directive 93/42/EEC concerning medical devices

(implemented in Italy with Legislative Decree 46/97), as amended by

Directive 2007/47/EC (Legislative Decree 37/2010) and subsequent

amendments/additions.

The device is classified class IIa, according to Annex IX, rule 9 of Directive

93/42/EEC (and subsequent amendments/additions) and is marked

The conformity of the product in question with the Directive 93/42/EEC

has been verified and certified by the Notified Body:

1936 - TÜV Rheinland Italy

Via Enrico Mattei 3, 20010 Polignano Milanese (MI), Italy

Certificate No.: HD60134521

according to the certification process provided for in Directive

93/42/EEC, Annex II (excluding point 4).

________________ _____________________

Place, date Legal representative

MASSIMO MARCON

Martellago, 31/07/2020

IACER Srl 4 MNPG338-00

Classifications

The I-PRESS device assumes the following classifications:

•class IIa device (Directive 93/42/EEC, annex IX, rule 9 and subsequent

amendments/additions);

•Class II with type BF applied part (Classif. EN 60601-1);

•IP21 protection degree device in relation to the penetration of liquids

and dust.

•device and applicators not subject to sterilisation;

•device not suitable for use in the presence of a flammable anaesthetic

mixture with air or with oxygen or with nitrous oxide;

•device intended for continuous operation;

•device not suitable for external use.

Intended purpose and scope of use

Clinical purpose: Therapeutic

Scope of use: OutpatientClinic/Hospital and home

The I-PRESS device for pressotherapy is ideal for the treatment of diseases

affecting the circulatory system, in order to improve peripheral blood

circulation. This type of device is designed for the following applications:

-Oedema

-Lymphedema

-Venous ulcers

-Venous insufficiency

-Muscle recovery

The device can be used by patients themselves. In this case they will also

assume the role of operator during therapy.

The minimum age for patients to use the device is 18 years.

IACER Srl 5 MNPG338-00

Technical specifications

Feature

Specification

Power supply

Mains power supply 230V AC, 50Hz

Fuses

T1A x1

Total consumption

100mA max

Insulation (EN 60601-1)

Applied parts (EN 60601-1)

Dimensions

(Length x Width x Height)

260 x 200 x 125 mm

Weight

2 kg

IP protection

IP21

Pressure

200 mmHg (±20%)

Treatment duration

0 ÷ 30 minutes

Operation

Continuous

Conditions of use

Ambient

temperature

From +5 to +40°C

Relative humidity

From 15 to 93%

Atmospheric

pressure

700-1060 hPa

Storage/transport conditions

Ambient

temperature

From +5 to +40°C

Relative humidity

From 15 to 93%

Atmospheric

pressure

700-1060 hPa

Useful life of the device: 3 years.

IACER Srl 6 MNPG338-00

Device description and controls

No. Feature Description

1 Timer Time setting knob

2 Pressure Pressure setting knob

IACER Srl 7 MNPG338-00

Labelling

Symbol

Meaning

Manufacturer's logo.

Product certification issued by notified body No. 1936.

Device with type BF applied part according to EN 60601-

1 ed. III.

IACER Srl 8 MNPG338-00

Symbol

Meaning

Class II device

Manufacturer data.

Date of manufacture (YYYY-MM).

Consult the user manual.

WEEE directive for the disposal of electronic and

electrical waste.

Serial number

IP21

Degree of protection against entry of solids, dusts and

liquids (device protected against solid foreign bodies

with a

diameter of ≥12.5mm and against the vertical fall

of water drops).

IP21

Caution, danger.

Allowed temperatures (storage temperatures, on

packaging)

Relative humidity (storage relative humidity, on

packaging)

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