Gima 28210 Скачать руководство пользователя страница 8

19

 NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER 

MAKE SURE THAT CHILDREN AND/OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT 

ADULT SURVEILLANCE

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard 

(2014).

The VEGA surgical aspirator is an electro-medical device that requires particular precautions regarding elec-

tro-magnetic compatibility and which must be installed and commissioned according to the electro-magnetic 

compatibility information supplied. Portable and mobile radio communication devices (mobile phones, trans-

ceivers, etc.) may interfere with the medical device and should not be used in close proximity with, adjacent 

to or on top of the medical device. If such use is necessary and unavoidable, special precautions should be 

taken so that the electro-medical device functions properly in its intended operating configuration (for exam-

ple, constantly and visually checking for the absence of anomalies or malfunctions). The use of accessories, 

transducers and cables differing from those specified, with the exception of transducers and cables sold by 

the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease 

of the immunity of the device or system. The following tables supply information regarding the EMC (Electro-

magnetic Compatibility) characteristics of the electro-medical device.

ENGLISH

Guidance and manufacturer’s declaration – electromagnetic Emissions
The VEGA SUCTION UNIT is intended for use in the electromagnetic environment specified below. The customers or the 

user of the VEGA SUCTION UNIT should make sure that it’s used in such an environment.
Emissions test

Compliance

Electromagnetic environment - guidance

Irradiated / Conducted 

emissions CISPR11

Group 1

The VEGA SUCTION UNIT only used RF energy only for its internal 

functioning. Therefore, its RF emissions are very low and are not 

cause interference in proximity of any Electronic appliances.

Irradiated / Conducted 

emissions CISPR11

Class [B]

The  VEGA SUCTION UNIT  can  be  used  in  all  environments,  in-

cluding domestic and those connected directly to the public mains 

distribution that supplies power to environments used for domestic 

scopes.

Harmonic emissions 

EN 61000-3-2

Class [A]

Voltage fluctuations / flicker 

emissions EN 61000-3-3

Complies

ON/OFF Switch

Antibacterial Filter

Vacuum 

Regulator Knob

Conical Fittings

VACUUM Port

PATIENT Port

Autoclavable Silicone Tube

Vacuum Indicator 

(kPa /Bar)

Содержание 28210

Страница 1: ...HIRURGISCHER ABSAUGER VEGA ASPIRADOR QUIR RGICO VEGA APARELHO DE SUC O CIR RGICO VEGA M28210 M Rev 7 12 20 PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly...

Страница 2: ...rtment Do not attempt to make the device work before it has been thorough ly checked by qualified personnel and or the GIMA technical service department Position the device on stable and flat surfaces...

Страница 3: ...nce they contain small parts that may be swallowed 14 Do not leave the device unattended in places accessible to children and or persons not in full possession of mental facultiesas they may strangle...

Страница 4: ...on pump is used on patients in unknown pathological situations and where an assess ment of indirect contamination is not possible The filter is not manufactured to be decontaminated dismantled and or...

Страница 5: ...of local laws and regulations The jug and lid can be further disinfected using a common disinfectant strictly following the instructions and dilution values provided by the manufacturer At the end of...

Страница 6: ...nents list descriptions setting in structions and any other information that can help the technical assistance staff for product repair BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNC...

Страница 7: ...the presence of liquids or other visible contamination secretions In the presence of liquids or other visible contamination immediately replace the medical device due to the risk of an insufficient v...

Страница 8: ...d cables sold by the appliance and system manufacturer as spare parts can lead to an increase in emissions or in a decrease of the immunity of the device or system The following tables supply informat...

Страница 9: ...ains power quality should be that of a typi cal commercial environment or hospital If the user of the VEGA SUCTION UNIT request that the appliance operates continuously the use of a continuity unit is...

Страница 10: ...es 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...

Страница 11: ...EEE disposal Class II applied Serial number Temperature limit Fuse Atmospheric Pressure limit IP21 Covering Protection rate Alternating current ON Hz Mains frequency OFF Humidity limit SYMBOLS Disposa...

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