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USER MANUAL

Pressotherapy

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Страница 1: ...USER MANUAL Pressotherapy...

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Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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