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IACER Srl

6

MNPG338-00

Device description and controls

No.

Feature

Description

1

Timer

Time setting knob

2

Pressure

Pressure setting knob

1

2

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Summary of Contents for I-Press

Page 1: ...USER MANUAL Pressotherapy...

Page 2: ......

Page 3: ...IPTION 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 THERAP...

Page 4: ...ii...

Page 5: ...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 cl...

Page 6: ...r 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...

Page 7: ...h 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 Rela...

Page 8: ...IACER Srl 6 MNPG338 00 Device description and controls No Feature Description 1 Timer Time setting knob 2 Pressure Pressure setting knob 1 2...

Page 9: ...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...

Page 10: ...ectronic 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...

Page 11: ...contains LEG2 right leg cuff left leg cuff 4 chamber 8 ending tube two pressure orthotics LEG1 leg cuff right or left 4 chamber 4 ending tube one pressure orthotic ARM1 arm cuff right or left 4 chamb...

Page 12: ...cess interstitial fluids to return more easily to the circulatory system so that they can be properly and quickly eliminated Contraindications Undesirable effects may occur if the device is used in th...

Page 13: ...t the mains plug can be easily disconnected use ONLY applicators supplied by the manufacturer It is forbidden for the device to be used by people of unsound mind who suffer from sensitivity disorders...

Page 14: ...ns modifications and or repairs are carried out by authorised personnel the electrical system of the environment in which I PRESS is inserted complies with national laws the devices is used in strict...

Page 15: ...cut the non woven fabric band according to the shape of the pressure orthotics and place it between the foot and the pressure orthotics 1 1 4 When wearing the leg cuffs make sure that the connection i...

Page 16: ...se 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 t...

Page 17: ...the ON OFF switch on the device body so that it is ON 6 At the end of the therapy press the ON OFF switch OFF 7 It takes about 2 minutes for the air to flow into the chambers inside the applicators O...

Page 18: ...ion of oedema and resulting inflammation Lymphedema dedicated program for reducing the volume of the lymphedematous limb Condition Pressure mmHg Time min Recommended applicator Therapy cycle Oedema 50...

Page 19: ...this sense by personnel not authorised by the manufacturer will be considered tampering with the device thereby avoiding the manufacturer s warranty and freeing it from liability for any hazards to w...

Page 20: ...se heat direct sunlight and liquids Store the device in a cool and well ventilated environment Do not place heavy objects on top of the device Storage precautions Environmental operating conditions am...

Page 21: ...ack on and see if it operates correctly Pressure is too strong and or the patient feels discomfort 1 Reduce the pressure using the appropriate knob 2 Turn off the device and detach the applicators to...

Page 22: ...93 42 EEC the manufacturer is obliged to trace at any time the equipment supplied to intervene promptly if necessary as a result of manufacturing defects The warranty conditions are those described in...

Page 23: ...In this case all the assistance interventions will be performed by debiting the costs of the substitution of the parts the hand work and the transportations costs 10 The court of Venice has exclusive...

Page 24: ...y to radiating electromagnetic fields Under these conditions harmful interference cannot occur to radioelectric communications and to the operation of electro medical devices used for monitoring diagn...

Page 25: ...romagnetic environment guidance RF emissions CISPR 11 Group 1 I PRESS uses RF energy only for its internal operation Therefore its RF emissions are very low and not likely to cause any interference in...

Page 26: ...lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV line line 1kV line line Mains power quality should be that of a typical commercial or h...

Page 27: ...ESS must ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 95 dip in UT for 5s 95 dip in UT for 5s Magnetic field a...

Page 28: ...equipment should not be used near any part of the device including cables except when respecting the recommended separation distances calculated from the equation applicable to the transmitter freque...

Page 29: ...and 800MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by the absorption and reflection from structures objects and p...

Page 30: ...tance according to frequency of transmitter m 150 80 150 80 for ISM band from 80 800 800 2 7G 800 6G to radio frequency wireless communication equipment 0 01 0 12 0 2 0 12 0 23 0 1 0 38 0 63 0 38 0 73...

Page 31: ...IACER Srl 29 MNPG338 00 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 12th October 2020...

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