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Guidance and manufacturer’s declaration –electromagnetic immunity

The

PRO

NEB

®

 ULTRA II is intended for use in the electromagnetic environment specified below. The customer or the user of the 

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 ULTRA II should assure that it is used in such an environment.  

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment 

guidance

Conducted RF 
IEC 61000-4-6 

Radiated RF 
IEC 61000-4-3 

3 Vrms 
150 kHz to 80 MHz 

3 V/m 
80 MHz to 2,5 GHz 

3 Vrms 
150 kHz to 80 MHz 

3 V/m 
80 MHz to 2,5 GHz 

Portable and mobile RF communications equipment 
should be used no closer to any part of the 

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NEB®

ULTRA II, including cables, than the recommended 
separation distance calculated from the equation 
applicable to the frequency of the transmitter. 

Recommended separation distance  

P

V

d

=

1

P

E

d

=

1

80 MHz to 800 MHz

P

E

d

=

1

7

  800 MHz to 2,5 GHz

where 

P

is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter 
manufacturer and 

d

 is the recommended separation 

distance in metres (m).

Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey, 

a

should be less 

than the compliance level in each frequency range. 

b

Interference may occur in the vicinity of equipment 
marked with the following symbol:  

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.  

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection 
from structures, objects and people.  

a

 Field 

strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the 
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the 
measured field strength in the location in which the 

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NEB

®

 ULTRA II is used exceeds the applicable RF compliance level 

above, the

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®

 ULTRA II should be observed to verify normal operation. If abnormal performance is observed, 

additional measures may be necessary, such as re-orienting or relocating the

 PRO

NEB

®

 ULTRA II . 

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [

V

1

] V/m.

3,5

3,5

English

9

Summary of Contents for Proneb Ultra II

Page 1: ...N E B U L I Z E R INSIDE INSTRUCCIONES DE USO Read instructions and safety precautions before use INSTRUCTIONS FOR USE Leer las instrucciones y precauciones de seguridad antes de utilizar el producto...

Page 2: ...or Limited Warranty Repair Return Procedure English Espa ol I II III IV V VI VII VIII IX 13 13 14 16 16 17 20 21 22 Contenido Introducci n Caracter sticas y Funciones Precauciones de Seguridad Para Em...

Page 3: ...Illustrations Ilustraciones 6 7 8 7a 7b 1 2 3 4 5 FIGURE A FIGURE C FIGURE E FIGURE F FIGURE D FIGURE B 7 7 2...

Page 4: ...Use are included with the enclosed PARI Reusable Nebulizer Before using your PRONEB ULTRA II Compressor you should read and understand the entire Instructions For Use for both the PRONEB ULTRA II Comp...

Page 5: ...ids inside the case Return the product to an authorized PARI Service Center for examination and repair 3 Keep all electrical cords away from heated surfaces Do not overload wall outlets or use extensi...

Page 6: ...or mentally impaired or children Never use while sleeping or drowsy This product contains small parts that may present a choking hazard to small children The tubing also presents a strangulation haza...

Page 7: ...able based on the patient s age and condition The PRONEB ULTRA II Compressor was designed for intermittent use to deliver respiratory medications not continuous use for humidification or prolonged tre...

Page 8: ...emissions IEC 61000 3 3 Not applicable The PRONEB ULTRA II is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supp...

Page 9: ...kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on pow...

Page 10: ...d RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with...

Page 11: ...r clockwise to tighten Refer to p pa ag ge e 2 2 F Fiig gu ur re e E E Recommended separation distances between portable and mobile RF communications equipment and the PRONEB ULTRA II The PRONEB ULTRA...

Page 12: ...r PARI warrants that the PRONEB ULTRA II Compressor and its parts will be free from defects in workmanship and materials for a period of sixty 60 months from the date of first retail purchase of the e...

Page 13: ...es so the above limitations or exclusions may not apply to you This warranty gives you specific rights You may also have other rights which vary from State to State IX Repair Return Procedure 1 Contac...

Page 14: ...le PARI incluido tiene sus propias instrucciones de uso Antes de usar el compresor PRONEB ULTRA II debe leer y comprender completamente las Instrucciones de uso tanto del compresor PRONEB ULTRA II com...

Page 15: ...ad 1 Antes de usar el compresor PRONEB ULTRA II revise la etiqueta del n mero de serie en la parte inferior de la unidad para asegurarse de que el voltaje y la corriente indicados coincidan con el vol...

Page 16: ...tica del dispositivo 14 No use el dispositivo junto o sobre otros equipos Si es indispensable utilizarlo junto o sobre otros equipos se debe observar el dispositivo para comprobar que funcione normal...

Page 17: ...n las instrucciones de uso 6 Es importante insertar firmemente el tubo Wing Tip hasta el fondo de la salida de aire del compresor antes de iniciar el tratamiento Consulte la p p g giin na a 2 2 f fiig...

Page 18: ...y y A Allm ma ac ce en na am miie en nt to o Temperatura Ambiente _______________________________________ 40 C a 70 C Humedad Relativa _____________________________________________10 a 95 Presi n Atm...

Page 19: ...os r pidos en r fagas IEC 61000 4 4 Picos de voltaje IEC 61000 4 5 Campo magn tico de frecuencia de red 50 60 Hz IEC 61000 4 8 70 UT ca da del 30 en UT en 25 ciclos 40 UT ca da del 60 en UT en 5 ciclo...

Page 20: ...ser menor al nivel de cumplimiento en cada intervalo de frecuencias Pueden haber interferencias en las proximidades del equipo marcado con el siguiente s mbolo NOTA 1 a 80 MHz y 800 MHz se aplica el i...

Page 21: ...d 1 P E d 1 P E d 1 7 0 01 12 12 23 0 1 37 37 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 3 5 3 5 Distancias de separaci n recomendadas entre equipos port tiles y m viles de comunicac...

Page 22: ...usivamente N No ot ta a el compresor PRONEB ULTRA II no tiene en su interior ninguna pieza que necesite mantenimiento por parte del usuario La manipulaci n de las piezas por cualquier persona que no p...

Page 23: ...O UN TERCERO INCLUIDOS AUNQUE NO EXCLUSIVAMENTE LOS DA OS DERIVADOS DE P RDIDA DE BENEFICIOS P RDIDA DE OPORTUNIDADES DE NEGOCIO P RDIDAS ECON MICAS DA OS LEGALES O EJEMPLARES YA SEA POR NEGLIGENCIA...

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