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Globus MEDISOUND 1000, User Manual

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31

Rev.2.13.A

TAB. 202

GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER

TUTTI GLI APPARECCHI ED I SISTEMI

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

– FOR ALL EQUIPMENT AND SYSTEMS

MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto

specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso

viene usato in tale ambiente.

MEDISOUND  3000  is  intended  for  use  in  the  electromagnetic  environment

specified below. The customer or the user of the MEDISOUND 3000 should assure

that it is used in such an environment.

Prova di immunità

Immunity Test

Livello  di  prova

IEC 60601

IEC  60601  test

level

Livello 

di

conformità

Compliance level

Ambiente

elettromagnetico

–

Guida

Electromagnetic

environment

-

Guidance

hospital  environment.

If  the  user  of  the

MEDISOUND 

3000

requires 

continued

operation 

during

power 

mains

interruptions, 

it 

is

recommended 

that

the  MEDISOUND  3000

be  powered  from  an

uninterruptible  power

supply or a battery

Campo

magnetico 

a

frequenza  di  rete

(50/60 Hz)

Power frequency

(50/60 

Hz)

magnetic field

IEC 61000-4-8

3 A/m

3 A/m

I  campi  magnetici  a

frequenza 

di 

rete

dovrebbero 

avere

livelli  caratteristici  di

una  località  tipica  in

ambiente

commerciale 

o

ospedaliero.

Power 

frequency

magnetic fields should

be 

at 

levels

characteristic  of  a

typical  location  in  a

typical  commercial  or

hospital environment

Nota_e

U

T

è  la  tensione  di  rete  in  c.a.  prima  dell’applicazione  del livello  di

prova

U

T

is the a.c. mains voltage prior to application of the test level

Summary of Contents for MEDISOUND 1000

Page 1: ...ULTRASOUND THERAPY MEDISOUND 1000 MEDISOUND 3000 User Manual ULTRASOUND THERAPY ...

Page 2: ...2 Rev 2 13 A ...

Page 3: ...y DOMINO s r l via Vittorio Veneto 52 31013 Codognè TV Italy Tel 39 0438 7933 Fax 39 0438 793363 E Mail info globuscorporation com www globuscorporation com This product has been manufactured according to the technical regulations in force and is certified according to Directive 93 42 EEC updated by 2007 47 directive for medical devices by CERMET Body authorization n 0476 in order to ensure the pr...

Page 4: ...rd 12 Display 12 ALARMS 13 MANDATORY BEHAVIOUR WARNINGS AND CONTRAINDICATIONS 14 Mandatory behavior 14 Warnings before the use 15 Warnings during the use 15 Side effects and contraindications 15 Contraindications 16 MAINTENANCE AND CLEANING 16 Maintenance and cleaning of the device 16 Disposal of the device 17 INSTRUCTIONS FOR USE 17 Turning on off 17 How to execute and start a program 18 Creating...

Page 5: ...5 Rev 2 13 A Direct contact method 22 Immersion method 22 MAIN AREAS TO BE TREATED 24 WARRANTY CONDITIONS 27 EMC TABLES 28 ...

Page 6: ...y DOMINO s r l via Vittorio Veneto 52 31013 Codognè TV Italy Tel 39 0438 7933 Fax 39 0438 793363 E Mail info globuscorporation com www globuscorporation com This product has been manufactured according to the technical regulations in force and is certified according to Directive 93 42 EEC updated by 2007 47 directive for medical devices by CERMET Body authorization n 0476 in order to ensure the pr...

Page 7: ...m 0 C to 35 C Max relative humidity from 15 to 93 Atmospheric pressure from 700 hPa to 1060 hPa Diffuser emissions Model 3000 2 frequencies of emission 1 3 MHz Model 1000 1 frequency of emission 1 MHz Diffuser Diffuser Head of Ø 4 2 cm Emission Continuous pulsed Duty Cycle 10 100 Maximum power 3 W cm 20 Protection level of the handpiece IP 68 Power supply Brand Alpha Elettronica Type AC DC PRI 115...

Page 8: ...efully the integrity of the device and its accessories All the supplied information can be modified without previous notice The device can be used with some optional accessories it is possible to see the features on the website www globuscorporation com If you are interested in buying these accessories please contact the retailer Accessories not included available on charge rechargeable battery Ni...

Page 9: ...centers rehabilitation centers general pain treatments medical treatments The use of the device is permitted to doctors and physiotherapists CONNECTIONS Device Power supply by electricity grid The Medisound 1000 and 3000 can operate connected to the mains the rechargeable battery is an accessory available on charge To connect the power supply to the connector plug it as shown below Diffuser To con...

Page 10: ...fied unit is 0476 It indicates that this is a II class device It indicates that this device has BF type parts WEEE symbol Waste of Electrical and Electronic Equipment Recycling symbol Recycling symbol The WEEE symbol used for this product indicates that the device may not be disposed for as a household product Properly dispose of the product to help protect the environment For more information on ...

Page 11: ...he mains voltage for the power supply Output Output it indicates the power supply outbound voltage it indicates the maximum power value of the magnetic field emitted by the device it indicates the range of frequencies of the magnetic field emitted by the device Type It indicates the device type Power It indicates he power supply model of the device Battery It indicates the battery pack inside the ...

Page 12: ... Button to switch on off and to confirm the treatment Fn Function button to change the power visualization Time Button To modify the duration of the treatment LEFT RIGHT button Buttons to navigate to return to the main menu P P Button Button to select the menu the area and the program Display ...

Page 13: ...ist contact the service centers Contact control no contact It is possible to disable the contact control symbol is shown on the upper right corner of the display up to the end of the ongoing treatment by pressing for more than 3 seconds the Fn button To enable the control again press the Fn button for more than 3 seconds Overheating alarm hot Red led lights up hot 3 sec blip is appearing on the di...

Page 14: ...D CONTRAINDICATIONS Mandatory behavior For safety reasons the device must be used in the prescribed manner and within the limits of use explained in this manual The manufacturer declines any responsibility due to a different use from what it is indicated in this manual No part of this manual texts and or photos may be reproduced by electronic or mechanical means without the prior written authoriza...

Page 15: ...appear turn it off and on again If the problem persists contact the service center and do not use the device An unexpected switching off of the device means that the battery has run down Charge it according to the instructions in the paragraph HOW TO CHARGE THE BATTERIES this can happen if the Medisound 1000 or 3000 are working using the battery pack purchased as optional accessory Warnings during...

Page 16: ...malfunction do not tamper with the device or try to repair it by yourself Do not intervene on the device and do not open it Only specialized and authorized centers can repair it Avoid violent impacts that may cause damage and malfunctions to the device even if undetectable immediately Use this device in a dry environment and in an open space not wrapped in any materials Clean the device and its ac...

Page 17: ... and promote the reuse and or recycle of materials of which the device is composed The illegal disposal of the product by the user involves the application of the administrative fines according to the current regulations INSTRUCTIONS FOR USE AUTOMATIC CALIBRATION OF THE HANDPIECES Every time the device has been turned on it automatically calibrates the head that must be always clean and used in an...

Page 18: ...tton and regulate the output power Watt with the Up and or Down buttons How to pause the program To pause the program press the OK button the power will zero Time stops Press OK again to return to the execution of the program During the pause the message PAUSE will appear on the screen How to stop the program To stop the program hold down the OK button until a beep is heard It appears the screen t...

Page 19: ...sible to create and memorize up to 30 new programs How to insert the program s name To place the cursor oh the space where you want to set the letter number use the Left and Right button Select the letter number using the UP DOWN Increase Decrease buttons After selecting the letter number confirm with the Left Right buttons and set the next letters After setting the name confirm with OK Using the ...

Page 20: ... the P and P buttons Confirm with the OK button AUTO SHUT OFF TIMER It permits to set the time after that the device if not used turns off It is possible to select a value from 1 to 20 minutes The selection is made using the P and P buttons and confirm with the OK button CONTRAST It permits to modify the contrast Use the P and P buttons to select and confirm with the OK button LANGUAGE ...

Page 21: ...n face and body The program is used for the application of cosmetic agents The ultrasound facilitates the absorption of oil fat soluble vitamins products with liposome emulsions and water soluble agents The effect is to increase the permeability of the cells to decrease the skin functional barrier and to increase the channel activity of the active ingredients Treatment for surface wrinkles and sen...

Page 22: ...lity of cellular membranes and with molecular changes is caused by the remarkable accelerating forces to which tissue particles are subjected to the passage of the ultrasonic wave The therapy with ultrasound can be used following two different methods direct contact with mobile head and immersion Direct contact method The direct contact modality consists in the application of the emission head to ...

Page 23: ...f the treatment In treatment with gas water the attenuation of the ultrasound power is more elevated than in the direct contact treatment for this reason more elevated dosage are required Instead when you use no gas water the dosage has to be the same used in the direct contact treatment Recommended intensity The device starts with a preset intensity of 0 1 Watt cm2 0 5 Watt and can reach a maximu...

Page 24: ...24 Rev 2 13 A MAIN AREAS TO BE TREATED ...

Page 25: ...ITIS x x 1 W cm OSTEOARTHRITIS x x 1 W cm PSEUDOARTHRITIS x x 1 W cm WRIST FRACTURE x x 0 3 W cm FATIGUE FRACTURE OF TIBIA x x 0 2 W cm FRACTURES x x 0 3 W cm CARPAL TUNNEL x x 1 W cm EPICONDYLITIS x x 1 5 W cm BACK PAIN x x 1 2 W cm CALCIFIED SHOULDER TENDINITIS x x 1 5 W cm MUSCLE PAIN x x 0 5 W cm CERVICAL PAIN x x 1 5 W cm TRAPEZIUS PAIN x x 1 2 W cm SPINAL STENOSIS x x 1 5 W cm Total Programs...

Page 26: ... TREAT x 0 5 1 Watt cm2 ABDOMEN RELAXATION x 1 2 Watt cm2 ABDOMEN ADIPOSITY x 1 2 Watt cm2 FLABBY THIGHS x 1 2 Watt cm2 THIGHS HIP DRAIN x 1 2 Watt cm2 THIGHS HIP MASS x 1 2 Watt cm2 GLUTEOUS HIP ADIP x 1 2 Watt cm2 RELAXATION x 0 5 1 Watt cm2 ARM LYNF DRAIN x 0 5 1 Watt cm2 BREAST STRETCH MARKS x 0 5 1 Watt cm2 BREAST RELAXATION x 0 5 1 Watt cm2 WRINKLE TREATMENT x 0 5 1 Watt cm2 SCARE TREATMENT ...

Page 27: ...ginal warranty expiry date and shall neither renew nor extend it 4 If prior to carrying out the repair work no defects are found the costs related to inspection times shall in any case be charged 5 The warranty becomes void where the fault has been caused by impacts falls erroneous or improper use of the product use of non original external feeders accidental events alteration replacement detachme...

Page 28: ...gia RF solo per il suo funzionamento interno Perciò le sue emissioni RF sono molto basse e verosimilmente non causano nessuna interferenza negli apparecchi elettronici vicini MEDISOUND 3000 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Emissioni RF RF emissions CISPR 11 Classe B Clas...

Page 29: ...tica ESD Electrostatic discharge ESD IEC 61000 4 2 6 kV a contatto_contact 8 kV in aria_air 6 kV a contatto_contact 8 kV in aria_air I pavimenti devono essere in legno calcestruzzo o in ceramica Se i pavimenti sono ricoperti di materiale sintetico l umidità relativa dovrebbe essere almeno 30 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative h...

Page 30: ...e commerciale o ospedaliero Mains power quality should be that of a typical commercial or hospital environment Buchi di tensione brevi interruzioni e variazioni di tensione sulle linee di ingresso dell alimentazione Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 buco in_dip in UT per_for 0 5 cicli_cycle 40 UT 60 buco in_dip in UV per_for ...

Page 31: ...level Livello di conformità Compliance level Ambiente elettromagnetico Guida Electromagnetic environment Guidance hospital environment If the user of the MEDISOUND 3000 requires continued operation during power mains interruptions it is recommended that the MEDISOUND 3000 be powered from an uninterruptible power supply or a battery Campo magnetico a frequenza di rete 50 60 Hz Power frequency 50 60...

Page 32: ... test level Livello di conformità Compliance level Ambiente elettromagnetico Guida Electromagnetic environment Guidance RF condotta Conducted RF IEC 61000 4 6 RF irradiata Radiated RF IEC 61000 4 3 3 Veff_Vrms da 150 kHz a 80 MHz 150 kHz to 80 MHz 3 V m da 80 MHz a 2 5 GHz 3 V 3 V m Gli apparecchi di comunicazione a RF portatili e mobili non dovrebbero essere usati più vicino a nessuna parte del M...

Page 33: ... sito potrebbe essere minore del livello di conformità in ciascun intervallo di frequenzab Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Si può verificare interferenza in prossimità di apparecchi contrassegnati dal seguente simbolo Interference may occur in the vicinity of equipment mark...

Page 34: ...ISOUND 3000 is used exceeds the applicable RF compliance level above the MEDISOUND 3000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MEDISOUND 3000 b L intensità di campo nell intervallo di frequenza da 150 kHz a 80 MHz dovrebbe essere minore di 3 V m Over the frequency range 150 kHz to...

Page 35: ...trasmettitore ove P è la potenza massima d uscita del trasmettitore in Watt W secondo il costruttore del trasmettitore For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordin...

Page 36: ...36 Rev 2 13 A DOMINO s r l via Vittorio Veneto 52 31013 Codognè TV ITALY Tel 39 0438 7933 Fax 39 0438 793363 E mail info globuscorporation com www globuscorporation com ...

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