PARI PRONEB MAX Aerosol Delivery System
INSTRUCTIONS FOR USE
For single patient use (one person) only.
IMPORTANT: READ INSTRUCTIONS AND SAFETY PRECAUTIONS BEFORE USE
US Federal Law restricts this device to sale by or on the order of a physician.
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 FATAL ILLNESS/INJURY, IMPROPER TREATMENT OR PROPERTY DAMAGE.
REMEMBER: Replace Your Reusable Nebulizer CUP Every SIX Months.
Welcome to the PRONEB® max experience! The PRONEB® max Aerosol Delivery System is designed from PARI’s long legacy of clinically proven products and consists oftwo important components: a PRONEB® max compressor and a PARI nebulizer. Your physician has prescribed the PRONEB® max to treat your respiratory symptoms because of PARI’s reputation for consistent particle size and fast treatments resulting in targeted delivery to the lungs. PARI products have been used in more than 25 clinical trials for new nebulizedmedications. Designed with the patient in mind, these instructions will help you achieve the best aerosol therapy experience.
INDICATIONS FOR USE: LC PLUS®The PARI LC PLUS® reusable nebulizer is used to deliver aerosolized medication to the lungs. This nebulizer is used with patients for whom a physician has prescribed medication for aerosol treatments in the home, doctor’s office, hospital, or clinic.
A. SAFETY PRECAUTIONS–LC PLUS®CAUTIONUS Federal Law restricts this device to sale by or on the order of a physician. Use only when prescribed by a physician and with the prescribed medication. The LC PLUS® is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC PLUS® is intended for adult and pediatric patients consistent with the indications for the aerosol medication. Improper use can result in serious or fatal illness or injury. Nebulizer is not sterile.
WARNING: Use only when 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 20psi.\
WARNING:
- To reduce the risk of increased bacterial growth, infection, illness, or injury from contamination: thoroughly clean and dry all parts of the nebulizer and thoroughly dry any moisture or condensation in the tubing at the end of every treatment following the instructions below.
- Cleaning the nebulizer after each treatment is not enough–you must regularly disinfect or sterilize the nebulizer between treatments to prevent serious or fatal illness caused by contamination of the nebulizer.
- Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, the aerosol mist will be reduced, altered or stopped, which will diminish or eliminate the effectiveness of the treatment. If clogging occurs, replace with the same model PARI Reusable Nebulizer.
- Close supervision is necessary when this product is used by or near children and physically or mentally impaired. Never use when 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 TREATMENT.
- Patients under the age of 4 or any patients who have special needs should use a facemask instead of the valved mouthpiece.
- Before use, check PARI Reusable Nebulizer for proper assembly. All parts should be seated firmly in place. Use of an improperly assembled nebulizer could diminish or prevent adequate delivery of medication and the effectiveness of the treatment.
INDICATIONS FOR USE: PRONEB® MAX AEROSOL DELIVERY SYSTEMThe PARI PRONEB® max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 2 years and older, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
B. SAFETY PRECAUTIONS–PRONEB® MAX AEROSOL DELIVERY SYSTEMENVIRONMENT OF USE:As a tabletop compressor, it is intended for use in home healthcare and professional care settings. It is not permitted for use in trains, motor vehicles, or airplanes. Within professional care settings, the device must only be used in in-patient wards and intensive care units. The device must never be used in areas exposed to elevated magnetic or electrical radiation (e.g. in the vicinity of an MRI scanner or electromagnetic security equipment).
WARNING: Use only with nebulizers and tubing authorized by PARI for this device. Other nebulizers and tubing may result in improper treatment. When using electrical and medical products, especially when children are present, basic safety precautions must be followed.
DANGERTo reduce the risk of serious or fatal injury from electrocution:
- Do not place or store 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.
- Do not reach for a product that has fallen into water or other liquid. Unplug immediately.
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 product:
- Before use, check the serial number label on the bottom of the PARI PRONEB® max Compressor to ensure that the voltage and current indicated on the compressor label correspond to the voltage and current available.
- 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. Return the product to PARI forexamination and repair.
- Keep all electrical cords away from heated surfaces. Do not overload wall outlets or use extension cords.
- 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.
- Never block the air vents of this compressor 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. Blocked vents could cause excessive heat buildup. This product should never be left unattended when plugged in.
- Do not operate outdoors.
- Not suitable for use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide.
- Do not operate where oxygen is being administered in a closed environment such as an oxygen tent.
- Never drop or insert any object into any openings.
- Always unplug this product immediately after using.
- Be sure the PARI PRONEB® max Compressor is unplugged prior to cleaning.
- Do not open or disassemble the PARI PRONEB® max Compressor. Refer all servicing to PARI.
WARNINGTo reduce risk that the compressor will fail to operate properly as a result of decreased electromagnetic interference, resulting in improper treatment:
- Portable and mobile radio frequency (“RF”) communication devices can disrupt electrical medical equipment.
- Use only with accessories and cables authorized by PARI for this device. Use of this device with unauthorized accessories and cables may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.
- This device should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, this device should be observed to verify normal operation.
PRONEB® MAX SET-UP
You are 10 Steps away from starting your treatment with PRONEB® max. Please follow step by step.
- Clean/Disinfect Nebulizer Cup: Refer to the instructions provided with your nebulizer to properly clean and/or disinfect your nebulizer prior to first use. Re-assemble nebulizer.
- Set-up Compressor: Place the compressor on a flat, stable surface free of dust. Avoid cushioned, upholstered or carpeted surfaces. Make sure power switch is turned to the “OFF” position. Plug power cord into wall outlet (Fig A).
- Connect Tubing To Compressor: Insert one end of tubing to the air outlet on the compressor. It should fit snugly (Fig. B).
- Load Medication: Remove the nebulizer insert by twisting counter-clockwise until it stops and lift up. Pour the prescribed dose of medication into the nebulizer cup (Fig.C). Never fill past the max. fill line of 8ml.
- Attach Mouthpiece or Mask: If using the mouthpiece, attach the mouthpiece to the nebulizer 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 to the mask instructions.
- Attach Tubing To Nebulizer Cup: Firmly press the other end of the tubing to bottom of PARI reusable nebulizer (Fig. D).
- Starting Treatment: Sit in a relaxed, upright position and turn the compressor “ON”.
- Nebulizer Position: Place the mouthpiece on top of tongue and close lips around it. Take slow, deep breaths. As you inhale, the inhalation valve opens.
- Breathing: For mouthpiece, inhale and exhale slowly through your mouth. As you exhale, the valve on the mouthpiece opens to allow the exhaled mist to escape. For mask, place mask over nose and mouth and inhale and exhale slowly.
- Complete Treatment: Continue until the medication is gone or you hear a slight “sputtering” sound. Turn compressor off.A NOTE ON TREATMENT TIMEPlease note that many factors affect treatment time, such as a patient’s age, condition, breathing pattern, and medication. The PRONEB® max was designed for intermittent use to deliver respiratory medications, not continuous use for humidification.
CLEANING YOUR PARI REUSABLE NEBULIZER
- Disconnect the tubing from the air intake on the bottom of the nebulizer cup.
- If there is any moisture (condensation) in the tubing, let the compressor run with only the tubing attached for 2-3 minutes. The warm air from the compressor will dry out the tubing. Alternatively, you can dry the tubing by removing it from the compressor and hanging it up with the “ends down” to allow any moisture (condensation) to drain out and evaporate. Use a clean damp cloth to wipe the exterior of the tubing.
- Disassemble reusable nebulizer parts as illustrated on page 3.
- Wash all parts with warm water and liquid dish soap. DO NOT WASH THE TUBING.
- Rinse the reusable nebulizer parts thoroughly with warm water and shake out water.
- Air dry or hand dry nebulizer parts on a clean, lintfree cloth. Reassemble nebulizer when parts are dry and store.
- You can also wash all parts of the reusable nebulizer on the top shelf of a dishwasher. DO NOT WASH TUBING. Place the reusable nebulizer parts in a dishwasher basket, then place the basket on the top rack of the dishwasher. Remove and dry the parts when the dishwasher cycle is complete.
WARNINGTO REDUCE RISK OF INFECTION:
- Nebulizer for single patient use (one person) only. Do not share your nebulizer with other patients.
- You must regularly disinfect or sterilize the nebulizer between treatments. Failure to do so could lead to serious or fatal illness.
DISINFECTING YOUR PARI REUSABLE NEBULIZER
- Clean the nebulizer as described in Section E. For low-level disinfection every other 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 equipment disinfectant (like Control III®) for distilled white vinegar (follow manufacturer’s instructions for mixing).
- Rinse all parts of the PARI Reusable Nebulizer thoroughly with warm tap water and dry with a clean, lint-free cloth. Discard the vinegar solution when disinfection is complete.
- The PARI Reusable Nebulizer parts (except tubing and mask) may also be disinfected by boiling them in a clean pot of water for a full 5 minutes.
- Hospitals and clinics can sterilize the PARI Reusable Nebulizer parts (except mask and tubing) by autoclaving (a maximum of 277° F or 136° C), follow autoclave manufacturer’s instructions.
- Dry parts on a clean, lint-free cloth.
REMEMBER: REPLACE YOUR REUSABLE NEBULIZER CUP EVERY SIX MONTHS
It is very important to replace your PARI reusable nebulizer every 6 months for the most effective treatments.Advantages of Replacing Your Nebulizer Cup:
- Consistent medication delivery to the lungs
- Fast and efficient treatments
- Bacterial contamination can be reduced*Included in this configuration is a reminder sticker. Place the sticker that corresponds to six months from date of first use to the smooth surface on the bottom of your nebulizer cup as indicated in this picture. Sticker is dishwasher safe. Allow two hours after label is applied before cleaning.WARNING: The sticker may present a choking hazard to small children-adult supervision is required.
MAINTENANCE OF YOUR PRONEB® MAX
The filter on the front of the PRONEB® max Compressor was designed to be monitored without removing it. This makes it easy to check without much work. When the filter is new, it is bright white in color. With use, the filter will turn grey, indicating the need for replacement. The filter must be replaced immediately if it gets wet or becomes clogged. A good rule to follow is to replace your filter every 6 months – at the same time as your PARI reusable nebulizer. For filter replacement, obtain the replacement filter set part #130F1002P2 which includes the filter and filter cap (Fig E). Pull the old filter and cap out of the compressor and discard (Fig F). Once the old filter and cap are removed, tilt the compressor so that the face of the unit is facing the floor. Gently tap on the back of the compressor to remove any unwanted materials from the filter area. Place the compressor on a stable surface and using clean hands, 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.
COMPRESSORUse a damp cloth to wipe the exterior of your PRONEB® max housing and tubing.
CAUTIONNever spray fluid into the ventilation slots on your PRONEB® max. Fluid could cause damage to the electrical & compressor parts and could lead to malfunction. In the event fluid enters the unit, please contact PARI Patient Connection at 1.800.FAST.NEB (327.8632).
MAINTENANCE & REPAIRNever operate your PRONEB® max if it is improperly or incompletely assembled or damaged. Use only original PARI parts and attachments authorized by PARI for the PRONEB® max Aerosol Delivery System. 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® MAX AEROSOL DELIVERY SYSTEM. SERVICE BY ANYONE VOIDS WARRANTY.
PRONEB® max REPLACEMENT ITEMS
LC Sprint® Reusable Nebulizer 023F35LC PLUS® Reusable Nebulizer 022F81Wing Tip® Tubing 044E0050PRONEB® max Replacement Filter 2pk 130F1002P2
SPECIFICATIONS
PRONEB® MAX SPECIFICATIONSWeight:………………………………………………………………………………………………………………………………………..3.75 lbs.Dimensions:…………………………………………………………………………………………………………………7.28 x 5.12 x 5.91 in.Electrical Requirements:………………………………………………………………………………………………….. 120V AC, 60Hz, 2APower Wattage:……………………………………………………………………………………………………… 98 W, under normal loadAmbient Operating Conditions:…………………………………………………………………………..10°C to 40°C, (50°F to 104°F)Power cord length:……………………………………………………………………………………………………………………………….5 ft.
TRANSPORT/STORAGE CONDITIONS:Ambient temperature:…………………………………………………………………………………….. -25 C to 70 C, (-13°F to 158°F)Relative Humidity:…………………………………………………………………………………………………………………… 10% to 93%Atmospheric Pressure:…………………………………………………………………………………………………..700 hpa to 1060 hpa
EXPLANATION OF SYMBOLSAttention: Read all “Instructions for Use” before operation:……………………………………………………………………………..Insulation enclosed Class II equipment:………………………………………………………………………………………………………….Type “BF” Protection from electrical shock:…………………………………………………………………………………………………….Do not dispose of in unsorted municipal trash.Please consult local laws and regulations for proper disposal:……………………………………………………………………………Power Switch:……………………………………………………………………………………………………………………………………………“On” Position (compressor running):…………………………………………………………………………………………………………….“Off” Position (compressor is not running):…………………………………………………………………………………………………
NOTE: WHEN SWITCH IS IN THE “OFF” POSITION AND THE COMPRESSOR IS NOT RUNNING, THERE WILL STILL BE ELECTRICAL POTENTIAL INSIDE THE COMPRESSOR HOUSING. TO REMOVE POWER FROM THE COMPRESSOR, THE POWER PLUG MUST BE REMOVED FROM THE POWER SOURCE.
ESSENTIAL PERFORMANCEThere are no essential performance characteristics according to the risk assessment.ELECTROMAGNETIC ENVIRONMENTThe 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. |
|
Immunity test |
IEC 60601 test level |
Compliance level |
Electromagnetic environment — Guidance | |||
| Power frequency (50 Hz / 60 Hz) magnetic field
IEC 61000-4-8 |
|
30 A/m |
|
30 A/m |
|
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital environment. |
| Conducted RF IEC 61000-4-6
Amplitude modulated |
|
150 kHz – 80 MHz
3 V ISM and amateur radio bands 6 V T 80 % / 1 kHz |
|
150 kHz – 80 MHz
3 V ISM and amateur radio bands 6 V T 80 % / 1 kHz |
|
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables, specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result. |
| Radio-frequency 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 antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables, specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result. |
| Proximity fields from RF wireless communications equipment |
|
IEC 61000-4-3 |
|
380 – 390 MHz 27 V/m;
PM 50 %; 18 Hz 430 – 470 MHz 28 V/m; (FM ±5 kHz, 1 kHz sine) PM; 18 Hz 704 – 787 MHz 9 V/m; PM 50 %; 217 Hz 800 – 960 MHz 28 V/m; PM 50 %; 18 Hz 1700 – 1990 MHz 28 V/m; PM 50 %; 217 Hz 2400 – 2570 MHz 28 V/m; PM 50 %; 217 Hz 5100 – 5800 MHz 9 V/m; PM 50 %; 217 Hz |
|
WARNING: Portable RF communications equipment (including peripherals such as antenna cables andexternal antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables, specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result. |
WARRANTY & RETURN INFORMATION
PRONEB® MAX AEROSOL DELIVERY SYSTEM LIMITED WARRANTYPARI offers a standard five (5) year limited warranty on the PRONEB® max Aerosol Delivery System and its parts. The warranty period will be printed on the serial number label located on the bottom of the compressor. PARI warrants that the PRONEB® max Aerosol Delivery System 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 equipment. This warranty does not cover failures of the nebulizer, tubing, or accessories. This warranty does not extend to failures resulting from accident, misuse, abuse, alteration, use of unauthorized service; parts or cleaning solutions, or failure to comply with Instructions For Use. If the warranted equipment should fail during the warranty period, PARI, at its option, will repair or replace the equipment or parts at issue, provided the claim is bona fide. It shall be the responsibility of the purchaser to pack and return the equipment in a manner to avoid shipping damage. The shipment must be prepaid to PARI Respiratory Equipment, Inc. This warranty covers the cost of labor incurred in the removal or replacement of the warranted component parts at authorized PARI service centers only. To make a claim under this warranty, notify the authorized service center by calling PARI Patient Connection at: 1.800.FAST.NEB (327.8632), Press 2.
THERE ARE NO OTHER EXPRESS WARRANTIES. ALL IMPLIED WARRANTIES ON THE PRONEB® max Aerosol Delivery System AND ITS PARTS, INCLUDING 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, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE DISCLAIMED. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply you. The sole and exclusive remedy under this warranty is to repair or replace the PRONEB® max Aerosol Delivery System and/or its parts at the option of PARI. IN NO EVENT SHALL PARI BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES TO THE PURCHASER OR ANY THIRD PARTY, INCLUDING WITHOUT LIMITATION, DAMAGES ARISING FROM LOST PROFITS, LOSS OF BUSINESS OPPORTUNITY, LOSS OF PROPERTY, ECONOMIC LOSSES, OR STATUTORY OR EXEMPLARY DAMAGES, WHETHER IN NEGLIGENCE, WARRANTY, STRICT LIABILITY OR OTHERWISE. Some states do not allow the exclusion or limitation of incidental or consequential damages, 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.
Register your PRONEB® max Aerosol Delivery System today with one of these three ways:Online at pari.com/registerCall 1.800.FAST.NEB (327.8632)Fill out the pre-addressed, postage paid registration card and drop it in any USPS Mailbox. Failure to register your PRONEB® max does not affect your standard product limited warranty. If you have any problems and need to return your PRONEB® max compressor, contact PARI Patient Connection at 1.800.FAST.NEB (327.8632).
References
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