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Guidance and manufacturer’s declaration – Immunity Emissions 

The surgical 

SUPERVEGA EVO BATTERY ASPIRATOR

 is intended for use in the electromagnetic environment specified below.  

The customers or the user of the surgical 

SUPERVEGA EVO BATTERY ASPIRATOR 

should assure that it’s used in such an environme

nt. 

Immunity Test 

Level indicated by 

the 

EN 60601-1-2 

Compliance 

Level 

Electromagnetic environment - guidance 

Conducted Immunity 
EN 61000-4-6 

3Vrms 150kHz to 

80Mhz 

(for non life-supporting 

devices) 

V

1

 = 3 V rms 

The portable and mobile RF communication devices, 
including cables, must not be used closer to the 

SUPERVEGA EVO

 device, than the separation distance 

calculated by the equation applicable to the transmitter 
frequency. Recommended separation distance 
d = [3.5 / V

1

P

d = [12 / E

1

P

from 80 MHz to 800MHz

d = [23 / E

1

P

from 800 MHz to 2.5 GHz

Where P is the maximum nominal output voltage of the 
transmitter in Watt (W) depending on the manufacturer of 

the transmitter and the recommended separation distance 
in metres (m). The intensity of the field from the fixed RF 

transmitters, as determined by an electro-magnetic study 
of the site

a)

,  could be lower than the level of conformity of 

each frequency interval 

b)

. It is possible to check for 

interference in proximity to devices identified by the 
following symbol: 

Radiated Immunity 

EN 61000-4-3 

3V/m 80MHz to 

2.5GHz 

(for non life-supporting 

devices) 

E

1

 = 3 V / m 

Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied 

Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the 
absorption and by reflection from buildings, objects and people. 

a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial

mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and 
accurately foreseen.  To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic 

study of the site should be considered. If the field intensity measured in the place where the device will be used surpasses the 
above mentioned applicable level of conformity, the normal functioning of the device should be monitored.  If abnormal 

performance arises, additional measures such as changing the device's direction or positioning may be necessary. 

b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.

Recommended separation distance between portable and mobile radio-communication devices and the monitor 

The 

SUPERVEGA EVO

 surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated 

interferences are under control. The client or operator of the 

SUPERVEGA EVO 

device can help prevent electro-magnetic 

interference by keeping a minimum distance between the portable and mobile RF communication devices (transmitters) and 
the 

SUPERVEGA EVO 

device, as recommended below, in relation to the radio-communication maximum output power. 

Maximum nominal 

output power of the 

Transmitter W 

Separation distance

 

from the frequency transmitter (m) 

150 kHz to 80 MHz 
d = [3.5 / V

1

P

80 MHz to 800 MHz 

d = [12/E

1

P

800 MHz to 2.5 GHz 

d = [23/E

1

P

0,01 

0,12 

0,12 

0,23 

0,1 

0,38 

0,38 

0,73 

1,2 

1,2 

2,3 

10 

3,8 

3,8 

7,3 

100 

12 

12 

23 

For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres 

(m) can be calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output 
power of the transmitter in Watt (W) depending on the transmitter's manufacturer. 

Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied 

Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the 

absorption and by the reflection from buildings, objects and people. 

Summary of Contents for SUPERVEGA EVO BATTERY ASPIRATOR

Page 1: ...0 Gessate MI Italy gima gimaitaly com export gimaitaly com www gimaitaly com PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy Made in Italy Instruction manual SUPERVEGA EVO BATTERY ASPIRATOR 230 V 28183 ...

Page 2: ...r immerge the appliance into water Do not place or store the aspirator in places where it may fall or be pulled into the bathtub or washbasin In the event it is accidentally dropped do not attempt to remove the device from the water whilst the plug is still connected disconnect the mains switch remove the plug from the power supply and contact the GIMA technical service department Do not attempt t...

Page 3: ...ormatives IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 2012 19 UE RAEE The symbol on the device indicates the separated collection of electric and electronic equipment At the end of life of the device don t dispose it as mixed solid municipal waste but dispose it referring to a specific collection centre located in your area or returring it to the distr...

Page 4: ...t the battery provided with this product shall not be treated as household waste By ensuring these batteries are disposed of correctly you will help prevent potentially negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of the battery The recycling of the materials will help to conserve natural resources At the end of their li...

Page 5: ...ting the said component Conical fitting the number of cycles of sterilization and the number of cleaning cycles is strictly linked to the employment of the said component Therefore after each cleaning cycle it is up to the final user to verify whether the fitting is suitable for reuse The component must be replaced if there are visible signs of decay in the material constituting the said component...

Page 6: ...evice is equipped with a Lithium Ion Battery which cannot be reached from the outside Only refer to GIMA technical service personnel to replace it The device should be checked at least once every 12 months by technical service Every 24 months it is compulsory to have a safety inspection and technical maintenance performed on the device ONLY USE BATTERIES RECOMMENDED BY GIMA USE OF BATTERIES OTHER ...

Page 7: ...ng adapter to the device with the appropriate connector and insert the power cable plug to the power socket To start the treatment press the ON OFF button and check its green back light When the device is switched on the LCD screen activates displaying a bar graph graduated scale and negative pressure value which must be set by the operator The negative pressure is set with keys and which are foun...

Page 8: ... cigarette lighter DC 12V Connect the device s external plug 12V to the ligther plug with the cigarette lighter cable Check the battery power status of the vehicle before the cigarette lighter cable Press the switch to start suction Press the switch to the I position to turn it on WARNING Only use the originally supplied or recommended replacement cigarette ligther cables view the chapter Importan...

Page 9: ...ed Battery operation guaranteed Fixed yellow back light During battery operation Intermediate status Battery not fully charged Battery operation guaranteed start the charge cycle upon activation of the red back light Fixed red back light During battery operation Low battery Start charge phase ATTENTION A long and continuous beep is produced during this signal to warn the operator about the low cha...

Page 10: ...he surgical SUPERVEGA EVO BATTERY ASPIRATOR is intended for use in the electromagnetic environment specifiedbelow The customers or the user of the surgical SUPERVEGA EVO BATTERY ASPIRATOR should assure that it s used in such an environment Emissions test Compliance Electromagnetic environment guidance Irradiated Conducted emissions CISPR11 Group 1 The surgical SUPERVEGA EVO BATTERY ASPIRATOR only ...

Page 11: ...itters and TV transmitters can not be theoretically and accurately foreseen To establish an electro magnetic environment generated by fixed RF transmitters an electro magnetic study of the site should be considered If the field intensity measured in the place where the device will be used surpasses the above mentioned applicable level of conformity the normal functioning of the device should be mo...

Page 12: ...not carried out by technical service RULES FOR RETURNING AND RAPAIRING UNDER NEW EUROPEAN RULES GIMA REQUIRES THE FOLLOWING PROCEDURES TO BECARRIEDOUT TO PROTECT THE INSTRUMENT ANDTHE SAFETY OF ALL WHO COME IN CONTACT WITH IT Before returning an instrument for repair the external surfaces and all accessories MUST be carefully disinfected with a cloth soaked in methylated spirits or hypochlorite ba...

Page 13: ...Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly com export gimaitaly com www gimaitaly com PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy ...

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