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Table of Contents
Related Manuals for I-Tech I-Press
Summary of Contents for I-Tech I-Press
- Page 1 USER MANUAL Pressotherapy...
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Page 3: Table Of Contents
Table of contents TABLE OF CONTENTS TECHNICAL INFORMATION ANUFACTURER ECLARATION OF CONFORMITY LASSIFICATIONS NTENDED PURPOSE AND SCOPE OF USE ECHNICAL SPECIFICATIONS EVICE DESCRIPTION AND CONTROLS ABELLING Pack contents HOW TO USE THE DEVICE NTRODUCTION TO THE TECHNOLOGY ONTRAINDICATIONS ARNINGS ATIENT PREPARATION SE OF DEVICE ECOMMENDED THERAPY SETTINGS LOOKING AFTER FOR THE DEVICE... -
Page 5: Technical Information
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... -
Page 6: Classifications
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:... -
Page 7: Technical Specifications
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 260 x 200 x 125 mm (Length x Width x Height) Weight 2 kg IP protection IP21 Pressure... -
Page 8: Device Description And Controls
Device description and controls Feature Description Timer Time setting knob Pressure Pressure setting knob IACER Srl MNPG338-00... -
Page 9: Labelling
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 MNPG338-00... - Page 10 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 Degree of protection against entry of solids, dusts and liquids (device protected against solid foreign bodies IP21 with a diameter of ≥12.5mm and against the vertical fall of water drops).
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Page 11: Pack Contents
Pack contents The I-PRESS pack in all configurations contains: 1 I-PRESS device with applicators; 1 user manual Non-woven fabric strip 15x150 cm (see page 13 for further details) The pack is supplied in 3 different versions depending on the type and also... -
Page 12: How To Use The Device
How to use the device Introduction to the technology Pressotherapy is a useful method for treating diseases and conditions affecting the circulatory system, as it is able to promote correct venous circulation, reducing muscle tension caused by stress or chronic and acute pain. Thanks to its pump action, it actually promotes venous return (see figure below), increasing the blood supply of the tissues and their consequent correct physiological renewal. -
Page 13: Warnings
• patients who have just undergone surgery, pregnant women, children; CONSULT YOUR DOCTOR BEFORE STARTING TREATMENT WITH THE DEVICE. Warnings It is recommended: to use the device keeping the applicator at least 3 metres away from • televisions, monitors, mobile phones or any other electronic equipment even if the device does not generate or receive any electromagnetic interference from other equipment;... -
Page 14: Patient Preparation
• the electrical system of the environment in which I-PRESS is inserted complies with national laws; the devices is used in strict compliance with the instructions reported in •... - Page 15 1.1.1. Attach the connector relating to the tube with 8 endings (for using two leg cuffs) or the connector relating to the tube with 4 endings if using a single leg cuff; 1.1.2. Put on the leg cuffs (or the single leg cuff) and close the zip up to the top, then close the Velcro fastener;...
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Page 16: Use Of Device
For correct use of the leg cuffs, use the zips on the leg cuffs and on the extensions to join the two elements, as shown in the figure above. Use of device To use the I-PRESS device: 1. Plug the power cable into the mains socket. 2. Put on the applicators suitable for the treatment you intend to perform and connect the relative connector to the device body. - Page 17 WARNING! The device will immediately begin delivering pressure into the worn applicators. WARNING! Once the therapy has started, do not force the timer by turning it anticlockwise. Wait for the end of the therapy to set the desired time again. 5.
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Page 18: Recommended Therapy Settings
Recommended therapy settings Condition Pressure Time (min) Recommended Therapy (mmHg) applicator cycle Oedema Leg cuff(s) 30 days Lymphoedema Leg/Arm cuff 30 days Venous ulcers Leg cuff(s) 30 days Venous Leg cuff(s) 30 days insufficiency Muscle Leg cuff(s) 30 days recovery If the 8-ending tube is used by connecting both leg cuffs, it is suggested to set the therapy pressures as follows: Condition... -
Page 19: Looking After For The Device
CLEANING It is advisable to switch off I-PRESS at the end of each therapy session, as well as to remove the cables from the appropriate connectors. -
Page 20: Troubleshooting
TRANSPORT AND STORAGE Transport precautions There is no particular care to be taken during transport as I-PRESS is a portable device. However, it is recommended to put I-PRESS and the relative applicators in the holder supplied after each use. Protect the device from intense heat, direct sunlight and liquids. -
Page 21: Disposal Information
Disposal Information I-PRESS devices, in line with operating and safety requirements, have been designed and built to have a minimum negative impact on the environment, following the provisions of the European Directive 2012/19/EU relating to the disposal of waste electrical and electronic equipment. -
Page 22: Warranty
Warranty IACER Srl guarantees a warranty period from the purchasing date for I-PRESS device, unless information contained in this manual regarding installation, use and maintenance is strictly adhered. The parts subject to wear and tear (pressure band) are excluded from the warranty, unless there are obvious manufacturing defects. -
Page 23: Support
4) Warranty means that only the manufacturing defect components or material are covered by reparation or free substitution, hand work included. 5) Warranty is not applied to damages caused by negligence or use not compliant to the given instructions, by intervention on the device from personnel not authorized, accidental causes or negligence form the purchaser. -
Page 24: Interference And Electromagnetic Compatibility Tables
Interference and electromagnetic compatibility tables The I-PRESS electrotherapy device is designed and built in compliance with the current TECHNICAL STANDARD on ELECTROMAGNETIC COMPATIBILITY EN 60601-1-2:2015, with the aim of providing reasonable protection against harmful interference in residential, civil and healthcare settings. - Page 25 Guidance and manufacturer's declaration - ELECTROMAGNETIC EMISSIONS - FOR ALL EQUIPMENT AND SYSTEMS I-PRESS is designed to work in the electromagnetic environment specified below. The customer or the user of I-PRESS must ensure that it is used in such an environment. Electromagnetic environment –...
- Page 26 Guidance and manufacturer's declaration - ELECTROMAGNETIC IMMUNITY - FOR ALL EQUIPMENT AND SYSTEMS I-PRESS is designed to work in the electromagnetic environment specified below. The customer or the user of I-PRESS must ensure that it is used in such an environment. Electromagnetic...
- Page 27 Guidance and manufacturer's declaration - ELECTROMAGNETIC IMMUNITY - FOR ALL EQUIPMENT AND SYSTEMS I-PRESS is designed to work in the electromagnetic environment specified below. The customer or the user of I-PRESS must ensure that it is used in such an environment. Electromagnetic...
- Page 28 IMMUNITY - FOR EQUIPMENT AND SYSTEMS NOT SUPPORTING VITAL FUNCTIONS I-PRESS is designed to work in the electromagnetic environment specified below. The customer or the user of I-PRESS must ensure that it is used in such an environment. IEC 60601...
- Page 29 FUNCTIONS I-PRESS is designed to work in the electromagnetic environment specified below. The customer or the user of I-PRESS must ensure that it is used in such an environment. where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
- Page 30 I-PRESS is intended to operate in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the operator of I-PRESS can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable RF communications devices (transmitters) and I- PRESS, as recommended below, according to the maximum output power of the radio communication devices.
- Page 31 I-PRESS. All rights reserved. I-PRESS and the logo are the exclusive property of I.A.C.E.R. Srl and are registered trademarks. Edition: MNPG338-00 of the 12 October 2020 IACER Srl MNPG338-00...