PARI PRONEB ULTRA II (01) PDF Document

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What are the features and functions of the PARI PRONEB ULTRA II?

The features and functions of the PARI PRONEB ULTRA II are as follows:

1. PRONEB® ULTRA II Compressor

2. Air Filter

3. Air Outlet

4. On/Off Switch

5. Reusable Nebulizer Holder

6. Wing Tip™ Tubing

7. a. PARI LC® Plus or PARI LC® Star Reusable Nebulizer
b. PARI LC® Sprint Reusable Nebulizer

8. Power Cord

What basic components are included with the PARI PRONEB ULTRA II?

Check the PARI PRONEB ULTRA II Compressor packing box to ensure the following basic components are included:

+ PRONEB® ULTRA II Compressor

+ Air Filter (in compressor)

+ PRONEB® ULTRA II Compressor Instructions For Use

+ PARI Reusable Nebulizer Set with Instructions For Use

Some models may include additional accessories such as an instructional DVD, carrying case, disposable nebulizer, etc.

How do I set up the PARI PRONEB ULTRA II for a treatment?

1. Place the PARI PRONEB ULTRA II Compressor on a stable, flat surface. Do not place on cushioned, upholstered, or carpeted surfaces. Place the unit in an area that is clean and free of dust.

2. Check the filter monthly or every 10-12 treatments. Details regarding when to replace the filter are covered under “Maintenance”.

3. Connect the polarized plug on the power cord to a polarized wall outlet. Open the nebulizer package and read and follow the nebulizer’s Instructions For Use.

4. Clean the nebulizer per the nebulizer Instructions For Use.

5. It is important to firmly push the Wing Tip™ Tubing all the way onto the air outlet of the compressor prior to starting the treatment. The tubing is designed to fit tightly.

6. Turn the compressor switch to the ON position. Take the treatment per your nebulizer Instructions For Use.

7. Press the compressor switch to the OFF position at the end of treatment.

Note: Your PARI PRONEB ULTRA II Compressor has a nebulizer holder on the rear of the unit. This nebulizer holder allows the nebulizer to be placed in the rear of the compressor with the Wing Tip™ Tubing attached.

What are the important safety precautions for using the PARI PRONEB ULTRA II?

When using electrical and medical products, especially when children are present, basic safety precautions should always be followed.

DANGER: To reduce the risk of serious or fatal injury from electrocution:

1. Do not place or store the product where it can fall or be pulled into a bathtub, sink, water, or other liquid. Do not place in or drop into water or other liquid. Do not use while bathing.

2. Do not reach for a product that has fallen into water or other liquid. Unplug immediately.

3. Always unplug this product immediately after using.

WARNING: To reduce the risk of serious or fatal injury from electrocution, fire or burns and to reduce the risk of damage and malfunction to the unit:

1. Before use, check the serial number label on the bottom of the PARI PRONEB ULTRA II Compressor to ensure that the voltage and current indicated on the unit correspond to the voltage and current available.

2. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or if it has been exposed to any liquids inside the case.

3. Keep all electrical cords away from heated surfaces. Do not overload wall outlets or use extension cords.

4. This appliance has a polarized plug (one blade is wider than the other). As a safety feature, this 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 product or place it on a soft surface, such as a bed or couch, where the air vents may be blocked. Keep the air vents free of lint, hair, and similar substances. Blockage could cause excessive heat buildup. A product should never be left unattended when plugged in.

6. Do not operate outdoors.

7. Do not operate where oxygen is being administered in a closed environment such as an oxygen tent.

8. Never drop or insert any object into any openings.

9. Be sure the PARI PRONEB ULTRA II Compressor is unplugged prior to cleaning.

10. Do not open or disassemble the PARI PRONEB ULTRA II Compressor.

11. Use only with accessories, transducers, and cables authorized by PARI for this device.

12. This device should not be used adjacent to, or stacked with other equipment.

13. Not suitable for use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide.

14. When the switch is in the off position and the compressor is not running there will still be electrical potential inside the unit. To remove power from the compressor the unit must be unplugged from the wall.

WARNING: Close supervision is necessary when this product is used by or near the physically 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 hazard. Always use close adult supervision when administering a treatment to a child. DO NOT LEAVE CHILD UNATTENDED DURING TREATMENTS.

What are the specifications of the PARI PRONEB ULTRA II?

Compressor Specifications:

Weight: 3 lbs. or 1300 grams

Dimensions: 6.5 x 6.5 x 3.75 in.

Electrical Requirements: 120V AC, 60Hz, 1.5A

Power Wattage: 80 W, under normal load

Ambient Operating Temperature Range: 10°C to 40°C, (50°F to 104°F)

Power Cord Length: 5 ft.

Transport/Storage Range:

Ambient Temperature: -40°C to 70°C, (-40°F to 158°F)

Relative Humidity: 10% to 95%

Atmospheric Pressure: 500 hpa to 1060 hpa

What do the symbols on the PARI PRONEB ULTRA II mean?

OFF/ON: Symbol represents the power switch.

Class II Equipment: Symbol represents double-insulated electrical equipment.

Type B Applied Part: Symbol represents that the applied part complies with specific requirements for protection against electric shock.

Ordinary Equipment (IPX0): According to the Ingress of Water.

Mode of Operation: continuous

How do I maintain the PARI PRONEB ULTRA II compressor?

Wing Tip™ Tubing Maintenance:

If there is any moisture or condensation in the Wing Tip™ Tubing after the treatment, let the compressor run with only the tubing attached for a few minutes. The warm air from the compressor will dry the moisture or condensation in the tubing. Use a damp cloth to wipe the exterior of the tubing.

Filter:

The Air Filter on the front panel of the PARI PRONEB ULTRA II Compressor is bright white. In time, the Air Filter will turn gray, which means it is time to replace it. You must replace the filter immediately if it gets wet or becomes clogged. The Air Filter will last for up to 500 hours before replacement. A good general rule is to replace the Air Filter whenever you replace your PARI Reusable Nebulizer (every 6 months).

To remove the Air Filter:

1. Make sure the PARI PRONEB ULTRA II Compressor is turned off.

2. Use a coin to turn the Air Filter cover counter clockwise.

3. Pull the cap and filter out and remove the filter from the cap.

To replace the filter:

1. Press the new filter into the cap with the open end visible.

2. Place the cap and filter back into the front of the compressor.

3. Use the coin to turn the filter cover clockwise to tighten.

Note: Do not attempt to wash and reuse the Air Filter. Do not use substitute filter material. Damage to the PARI PRONEB ULTRA II Compressor may result.

Cleaning the PRONEB® ULTRA II Housing and Wing Tip™ Tubing:

Use a damp cloth to wipe the exterior of the PARI PRONEB ULTRA II Compressor housing and Wing Tip™ Tubing.

WARNING: Never spray fluid into the ventilation slots on the PRONEB® ULTRA II Compressor. Fluid could cause damage to the electrical and compressor parts and could lead to a malfunction. In the event that fluid enters the unit, return the product to an authorized PARI Service Center for examination and repair.

Maintenance and Repair:

Never operate the PARI PRONEB ULTRA II Compressor if it is improperly or incompletely assembled, or damaged. Use only original PARI parts and attachments authorized by PARI for the PARI PRONEB ULTRA II Compressor. Use of other parts and attachments may damage the unit or cause improper treatment. Do not open or disassemble the compressor unit at any time.

Note: There are no serviceable parts inside the PRONEB® ULTRA II Compressor case. Service by anyone voids warranty.

What is the electromagnetic emissions guidance for the PARI PRONEB ULTRA II?

The PARI PRONEB ULTRA II is intended for use in the electromagnetic environment specified below. The customer or the user of the PRONEB® ULTRA II should assure that it is used in such an environment.

Emissions test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1	The PRONEB® ULTRA II 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.
RF emissions CISPR 11	Class B	The PRONEB® ULTRA II 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	Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3	Not applicable

What is the electromagnetic immunity guidance for the PARI PRONEB ULTRA II?

Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2	±6 kV contact ±8 kV air	±6 kV contact ±8 kV air	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	±2 kV for power supply lines ±1 kV for input/output lines	±2 kV for power supply lines ±1 kV for input/output lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	±1 kV differential mode ±2 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 power supply input lines IEC 61000-4-11	<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec	<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec	Mains power quality should be that of a typical commercial or hospital environment. If the user of the PRONEB® ULTRA II requires continued operation during power mains interruptions, it is recommended that the PRONEB® ULTRA II be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A / m	3 A / m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

What is the guidance for RF communications equipment near the PARI PRONEB ULTRA II?

Portable and mobile RF communications equipment should be used no closer to any part of the PRONEB® ULTRA II, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment- guidance
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz	3 Vrms 150 kHz to 80 MHz	Recommended separation distance d = [3.5 / V1] √P
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2,5 GHz	3 V/m 80 MHz to 2,5 GHz	d = [3.5 / E1] √P (80 MHz to 800 MHz) d = [7 / E1] √P (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 determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the symbol of radio waves.

What are the recommended separation distances between portable/mobile RF communications equipment and the PARI PRONEB ULTRA II?

The PRONEB® ULTRA II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the PRONEB® ULTRA II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PRONEB® ULTRA II as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter m
Rated maximum output power of transmitter W	150 kHz to 80 MHz d = [3.5/V1]√P	80 MHz to 800 MHz d = [3.5/E1]√P	800 MHz to 2.5 GHz d = [7/E1]√P
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

How do I return the PARI PRONEB ULTRA II for service?

1. Contact PARI Patient Connection for a customer service representative.

2. In writing, describe the malfunction or symptoms of the PRONEB® ULTRA II Compressor. Include your full name, address and daytime telephone number.

3. Send the written description and PRONEB® ULTRA II Compressor in a protective box to the address provided by Patient Connection.

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