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EN-8

ESSENTIAL PERFORMANCE

There are no essential performance characteristics according to the risk assessment.

ELECTROMAGNETIC ENVIRONMENT

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the 
device should assure that it is used in such environment.

EMISSION TEST

Emission test

Compliance

Electromagnetic environment — Guidance

RF emissions CISPR 11

Group 1

The device uses RF energy only for its internal function. Therefore, its 
RF-emission is very low and not likely to cause any interference nearby 
electronic equipment.

Class B

The device is suitable for use in all establishments, including domestic 
establishments and those directly connected to the public low-voltage 
power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-
3-2

Class A

Voltage fluctuations /flicker 
emissions
IEC 61000-3-3

Passed

IMMUNITY TEST

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic 

environment    — 

Guidance

Electrostatic discharge (ESD)
IEC 61000-4-2

Contact: ±8 kV
Air: ±15 kV

Contact: ±8 kV
Air: ±15 kV

Floors should be wood, concrete 
or ceramic tile. If floors are covered 
with synthetic material, the relative 
humidity should be at least 30 %.

Electrical fast transient /burst
IEC 61000-4-4

5/50 ns,
100 kHz, ±2 kV

5/50 ns,
100 kHz, ±2 kV

Mains power quality should 
be similar to that of a typical 
commercial or hospital 
environment.

Surge 
IEC 61000-4-5

1.2/50 (8/20) µs
LtL: ±1 kV
LtG: ±2 kV

1.2/50 (8/20) µs
LtL: ±1 kV
LtG: ±2 kV

Mains power quality should 
be similar to that of a typical 
commercial or hospital 
environment.

Voltage dips, short interruptions 
and voltage variations on power 
supply input lines
IEC 61000-4-11

0 % UT for 0.5 cycle (1 phase)
0 % UT for 1 cycle
70 % UT for 25/30 cycles (50/60 
Hz)
0 % UT for 250/300 cycles (50/60 
Hz)

0 % UT for 0.5 cycle (1 phase)
0 % UT for 1 cycle
70 % UT for 25/30 cycles (50/60 
Hz)
0 % UT for 250/300 cycles (50/60 
Hz)

Mains power quality should 
be similar to that of a typical 
commercial or hospital 
environment. When the user of the 
device requires continuous function 
in the event of disruption of supply, 
it is recommended the device is 
operated from an uninterruptible 
power supply or battery.

Summary of Contents for PRONEB

Page 1: ...SAFETY PRECAUTIONS BEFORE USE READ ALL WARNINGS AND INSTRUCTIONS BEFORE USE USE THE PRODUCT ONLY FOR ITS INTENDED USE AS DESCRIBED IN THESE INSTRUCTIONS FOR USE IMPROPER USE CAN RESULT IN SERIOUS OR...

Page 2: ...en prescribed by a physician and with the prescribed medication In order to achieve the specified droplet characteristics the compressor or central air supply must provide 3 5 8 lpm at a minimum of 20...

Page 3: ...is plug will fit in a polarized outlet only one way If the plug does not fit fully in the outlet reverse the plug 5 Never block the air vents of this compressor or place it on a soft surface such as a...

Page 4: ...le Nebulizer on hand at all times Air Outlet Air Filter PARI Reusable Nebulizer Holder Power Switch Wing Tip Tubing PARI Reusable Nebulizer 2 included Inspiratory Valve Cap Nebulizer Insert Nebulizer...

Page 5: ...izer outlet with the expiratory valve facing up Then close the inspiratory valve cap by pressing it firmly onto the top of the nebulizer If using a mask attach mask to the nebulizer outlet and refer t...

Page 6: ...treatment day soak all parts of the PARI Reusable Nebulizer except tubing and mask in a solution of 1 part distilled white vinegar and 3 parts hot tap water for 1 hour You can substitute respiratory...

Page 7: ...ds push a new filter with cap into the filter receptacle NOTE DO NOT ATTEMPT TO WASH AND REUSE AIR FILTERS DO NOT USE SUBSTITUTE FILTER MATERIAL AS COMPRESSOR DAMAGE MAY RESULT COMPRESSOR Use a damp c...

Page 8: ...ssure 700 hpa to 1060 hpa EXPLANATION OF SYMBOLS Attention Read all Instructions for Use before operation Insulation enclosed Class II equipment Type BF Protection from electrical shock Do not dispose...

Page 9: ...el Electromagnetic environment Guidance Electrostatic discharge ESD IEC 61000 4 2 Contact 8 kV Air 15 kV Contact 8 kV Air 15 kV Floors should be wood concrete or ceramic tile If floors are covered wit...

Page 10: ...electromagnetic field Amplitude modulated IEC 61000 4 3 80 MHz 2 7 GHz 10 V m T Home Healthcare T Prof Healthcare T 80 1 kHz WARNING Portable RF communications equipment including peripherals such as...

Page 11: ...NG IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED TO SIXTY 60 MONTHS FROM THE DATE OF FIRST RETAIL PURCHASE ALL EXPRESS OR IMPLIED WARRANTIES ON ANY OTHER PARTS...

Page 12: ...S ADVERTENCIAS E INSTRUCCIONES ANTES DE UTILIZAR EL EQUIPO USE EL PRODUCTO SOLO PARA EL PROP SITO QUE SE DESCRIBE EN ESTAS INSTRUCCIONES DE USO UN USO INCORRECTO PUEDE PROVOCAR TRASTORNOS LESIONES GRA...

Page 13: ...camente por indicaci n m dica y con el medicamento recetado Para lograr las caracter sticas de gota especificadas el compresor o suministro de aire central debe proporcionar de 3 5 a 8 lpm a un m nimo...

Page 14: ...e en una toma polarizada una sola posici n Si el enchufe no entra por completo en la toma delo vuelta 5 Nunca bloquee las ranuras de ventilaci n del compresor y tampoco ponga el compresor sobre superf...

Page 15: ...spiratoria Inserto del nebulizador Semic rculo del nebulizador Anillos de alineaci n Taza del nebulizador Entrada de aire Boquilla con v lvula espiratoria Salida del nebulizador Ubicaci n sugerida par...

Page 16: ...a v lvula inspiratoria presion ndola firmemente sobre la parte superior del nebulizador Si usa una mascarilla inst lela en la salida del nebulizador y consulte las instrucciones de la mascarilla D PRE...

Page 17: ...oluci n de una parte de vinagre blanco destilado y 3 partes de agua caliente del grifo durante 1 hora Puede reemplazar el desinfectante de equipos respiratorios como Control III por vinagre blanco des...

Page 18: ...del filtro NOTA NO INTENTE LAVAR Y REUTILIZAR LOS FILTROS DE AIRE NO USE OTRO MATERIAL PARA REEMPLAZAR EL FILTRO PUESTO QUE PUEDE DA AR EL COMPRESOR COMPRESOR Use un pa o h medo para limpiar el exteri...

Page 19: ...a 700 hPa a 1060 hPa EXPLICACI N DE S MBOLOS Atenci n Lea todas las Instrucciones de uso antes de utilizar el sistema Equipo de aislamiento cerrado Clase II Protecci n tipo B contra descarga el ctrica...

Page 20: ...4 2 Contacto 8 kV Aire 15 kV Contacto 8 kV Aire 15 kV El suelo debe ser de madera cemento o baldosas de cer mica Si el suelo est revestido de material sint tico la humedad relativa debe ser por lo men...

Page 21: ...modulada IEC 61000 4 3 80 MHz 2 7 GHz 10 V m T Atenci n m dica dom stica T Atenci n m dica profesional T 80 1 kHz ADVERTENCIA Los equipos de comunicaciones por RF port tiles incluidos perif ricos como...

Page 22: ...LIDAD Y ADECUACI N PARA UN PROP SITO PARTICULAR SE LIMITAN A SESENTA 60 MESES A PARTIR DE LA FECHA DE LA PRIMERA COMPRA EN EL MERCADO MINORISTA TODAS LAS GARANT AS EXPRESAS O IMPL CITAS SOBRE CUALQUIE...

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