PARI Trek Instructions for Use

Multi-Voltage AC Adapter

Power Cord

Tubing

Carrying Case

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PARI Reusable Nebulizer AI

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PARI COMPRESSOR NEBULIZER SYSTEM

Instructions For Use max

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PARI TREK Compressor

12V DC Adapter (optional accessory)

Portable Power Kit (optional accessory) Part# 46F25 PARI TREK Rechargeable Battery (optional accessory)

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1. PARI TREK COMPRESSOR ILLUSTRATION PARI TREK Compressor Air Outlet Air Filter On/Off Switch Nebulizer Holder Multi-Color Status Indicator Power Receptacle Removable Connection Cover (bottom view) Removable Connection Cover Storage (bottom view) Battery Connection (bottom view) Multi-Voltage AC Adapter Power Indicator Power Cord

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2. PARI REUSABLE NEBULIZER ILLUSTRATION 2

1 Inspiratory Valve Cap 2 Nebulizer Insert 3 Nebulizer Semi-Circle 4 Mouthpiece with Expiratory Valve 5 Nebulizer Outlet 6 Nebulizer Cup 7 Air Intake 8 Tubing

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3. PARI TREK RECHARGEABLE BATTERY AND 12V DC ADAPTER ILLUSTRATION (OPTIONAL PORTABLE POWER KIT)

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Charge Indicator Battery Level Indicator Release Button Charge Receptacle Battery Contacts 12V DC Adapter

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PARI COMPRESSOR NEBULIZER SYSTEM

Instructions For Use Page 1 PARI TREK Compressor Illustration...2 2 PARI Reusable Nebulizer Illustration...3 3 PARI TREK Battery & 12V DC Adapter Illustration...3 Other Illustrations...4-6 4 Introduction...8 5 Safety Precautions Compressor Safety Precautions...9 Nebulizer Safety Precautions... 11 Battery Safety Precautions...12 6 Getting Started...14 7 Compressor Set Up...15 Operation From a Wall Power Source...15 Operation Using 12V DC Adapter...16 Operation Using the Rechargeable Battery...16 8 Reusable Nebulizer Set Up...18 Treatment...19 Cleaning...21 Disinfecting and Sterilizing...22 9 Rechargeable Battery Charging...23 Storing...24 10 PARI TREK Compressor Maintenance...24 Specifications...26 Limited Warranty...27 Service and Repair...28

PARI TREK COMPRESSOR INSTRUCTIONS FOR USE 4. INTRODUCTION A LARGER TEXT VERSION OF THESE INSTRUCTIONS FOR USE IS AVAILABLE FOR VISUALLY IMPAIRED PATIENTS FREE OF CHARGE AT WWW.PARI.COM/PRODUCTSUPPORT/INSTRUCTIONS.HTML These instructions contain important information and safety precautions on the PARI TREK Compressor Nebulizer System. Illustrations of the proper set up of the PARI TREK Compressor are on page 2. l Illustrations of the proper set up of the PARI Reusable Nebulizer are on page 3. l Illustrations of the Rechargeable Battery and 12V DC Adapter for the PARI TREK Compressor are on page 3. l Open the fold-out pages in the front of these Instructions For Use to view the illustrations while reading the instructions. l

Before using your PARI TREK Compressor Nebulizer System, you should read and understand the entire Instructions For Use for the PARI TREK Compressor, PARI Reusable Nebulizer and optional portable power kit. Take special note of all safety precautions marked DANGER and WARNING. Save these instructions for future reference.

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5. SAFETY PRECAUTIONS IMPORTANT SAFEGUARDS READ ALL WARNINGS BEFORE USING YOUR PARI TREK COMPRESSOR NEBULIZER SYSTEM, BATTERY AND 12V DC ADAPTER.

WARNING Caution: U.S. 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. 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. Use only with nebulizers, tubing and accessories authorized by PARI for this device. Other nebulizers, tubing and accessories may result in improper treatment. Other compressors and tubing may produce incorrect liter flow, resulting in improper treatment. Use with other compressors, tubing, nebulizers and accessories should be reviewed with your healthcare professional. COMPRESSOR SAFETY PRECAUTIONS

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 knocked into bathtub, sink, water, or other liquid. Do not place or drop into water or other liquid. Do not use while bathing.

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2. Do not reach for a product that has fallen into water or other liquid. Unplug immediately. 3. Always unplug immediately after using.

WARNING To reduce the risk of serious or fatal injury from electrocution, fire, burns and to reduce the risk of damage and malfunction of the unit: 1. Before use, check the serial number label on the bottom of the compressor, battery and on the Multi-Voltage AC Adapter to ensure that the voltage and current indicated on the unit correspond with the voltage and current available. 2. Never operate this product if it: l has a damaged cord or plug, l is not working properly, l has been dropped or damaged, l has been exposed to any liquids inside the case. Return non-operating product to an authorized PARI Service Center for examination, repair or replacement. 3. Keep all electrical cords away from heated surfaces. Do not overload wall outlets or use extension cords. 4. Do not operate where oxygen is being administered in a closed environment such as an oxygen tent. 5. Never drop or insert any object into any openings. 6. Be sure the PARI TREK Compressor and the Multi-Voltage AC Adapter are unplugged prior to cleaning.

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7. Do not open or disassemble the PARI TREK Compressor. Refer all servicing to an authorized PARI Service Center. 8. Use only adapters that are authorized for the PARI TREK Compressor. Use of unapproved accessories can lead to improper treatment or damage to the compressor, adapters, or the battery. 9. Never spray liquids onto the compressor housing or battery. Fluid could cause damage to the electrical and compressor parts and could lead to a malfunction. In the event that fluids enter the unit, return the product to an authorized PARI Service Center for examination and repair. 10. Do not use the PARI TREK Compressor or the PARI Reusable Nebulizer while operating a vehicle. NEBULIZER SAFETY PRECAUTIONS

WARNING 1. Nebulizer is for single patient use (one person) only. Do not share your nebulizer with other patients. 2. 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. 3. Cleaning the nebulizer after each treatment is not enough---you must also regularly disinfect or sterilize the nebulizer between treatments to prevent serious or fatal illness caused by contamination of the nebulizer. 4. 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.

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5. Close supervision is necessary when this product is used by or near children and physically or mentally impaired persons. Never use when sleeping or drowsy. 6. 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. 7. Children under the age of 3 or any patient who is unable to use a mouthpiece properly under supervision should use a face mask. 8. 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. BATTERY SAFETY PRECAUTIONS

WARNING 1. Use only the PARI TREK Rechargeable Battery described in these Instructions For Use for operating your PARI TREK Compressor. 2. Do not immerse the PARI TREK Rechargeable Battery in water. 3. Do not touch the battery with wet or moist hands. 4. Do not expose battery to direct sunlight, humidity, extreme temperatures or chemicals. 5. Make sure battery poles do not come into contact with keys or other metal objects, causing a "short circuit".

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6. Battery is protected from overheating. Battery may not operate if temperature is 104ºF (40ºC) or higher. Allow battery to cool before restarting. 7. To charge the PARI TREK Rechargeable Battery use only the PARI TREK Multi-Voltage AC Adapter (part number 46F0002) or optional 12V DC Adapter (part number 46F0010). Using other adapters may damage the battery. 8. In case of failure in charging or operating, unplug the Rechargeable Battery from the MultiVoltage AC Adapter and turn the unit off. Should the Rechargeable Battery fail to charge or operate improperly, even if the Instructions For Use are followed, notify the authorized service center by calling PARI Patient Connection toll free (USA) at 1.877.943.3931, then press 1. 9. Do not attempt to open the plastic case or to replace any components. Do not disassemble Rechargeable Battery. The Rechargeable Battery is a sealed unit and can not be repaired. 10. Protect the environment: when replacing the Rechargeable Battery, recycle old battery or dispose of properly in accordance with local laws. 11. Do not incinerate (burn).

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SAVE THESE INSTRUCTIONS 6. GETTING STARTED 1. Check the box to make sure the following basic components of the PARI TREK Compressor Nebulizer System are enclosed: l PARI TREK Compressor l Multi-Voltage AC Adapter l Power Cord l PARI LC® Reusable Nebulizer (See page 3 for illustration of parts) l Tubing l Carrying Case l PARI TREK Compressor Nebulizer System Instructions For Use with warranty card l Patient Instructional Video

If you did not receive the components listed, please contact the dealer where you purchased your PARI TREK Compressor Nebulizer System. 2. Completely fill out the postage-paid warranty card on the back cover and mail. 3. It is always a good idea to keep an extra PARI Reusable Nebulizer (part number 22F81 for PARI LC Plus® or 22F51 for PARI LC Star®) and an extra PARI TREK Compressor Air Filter (part number 41E4851) on hand at all times. You may need them if parts become lost, damaged, or soiled.

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7. COMPRESSOR COMPRESSOR SET UP 1. Place the PARI TREK Compressor on a stable flat surface. Place the unit in an area that is clean and free of dust. NOTE: Check the filter monthly or every 10-12 treatments and replace immediately if dirty, clogged, or wet to ensure proper operation of the compressor. OPERATION FROM A WALL POWER SOURCE 1. Plug the Power Cord into the wall outlet. Connect the other end of the Power Cord into the Multi-Voltage AC Adapter. Power Indicator on Multi-Voltage AC Adapter will illuminate green. Next, plug the Multi-Voltage AC Adapter into the Power Receptacle on the side of the PARI TREK Compressor. Refer to page 4 figure A. 2. The PARI TREK Multi-Voltage AC Adapter (part number 46F0002) automatically adjusts to the incoming voltage (100-240V) so that it can be used in most countries. For use internationally, plug pattern adapters (part number 44F2207 Adapter Plug Set) may be needed to plug your Power Cord into the wall outlet. See voltages listed on the Multi-Voltage AC Adapter label for more specific information. 3. The Multi-Color Status Indicator on the PARI TREK Compressor will illuminate green when the compressor is operating.

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OPERATION USING 12V DC ADAPTER (optional accessory): NOTE: Do not use the PARI TREK Compressor or the PARI Reusable Nebulizer while operating a vehicle. 1. Plug the 12V DC Adapter into the vehicle outlet and plug the other end of the adapter into the Power Receptacle on the side of the PARI TREK Compressor. Refer to page 4 figure B. NOTE: Best results will be achieved when the car engine is running. 2. The Multi-Color Status Indicator on the PARI TREK Compressor will illuminate green when the compressor is operating. OPERATION USING THE RECHARGEABLE BATTERY (optional accessory): 1. Completely charge the battery before using for the first time. Refer to Charging the Battery on page 23. 2. The Rechargeable Battery can not be connected to the PARI TREK Compressor if either the Multi-Voltage AC Adapter or 12V DC Adapter are plugged into Power Receptacle. Refer to page 4 figure C. 3. To uncover the Battery Connection, remove the blue Removable Connection Cover from the bottom of the compressor. Refer to page 4 figure C. 4. Set the blue Removable Connection Cover into the storage area provided in the bottom of the PARI TREK Compressor. Refer to page 4 figure C. 5. Attach the PARI TREK Compressor to the Rechargeable Battery by placing it on top of the battery and sliding it into place. Refer to page 4 figure C. There will be an audible click once the battery is locked into place. Ensure battery is securely locked onto the compressor before use.

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6. The Multi-Color Status Indicator on the PARI TREK Compressor will illuminate green when the compressor is operating. 7. Use the Battery Charge Indicator light to determine the condition of the Battery: GREEN – Battery is plugged into the wall outlet and is fully charged. ORANGE – When blinking, Battery must be recharged. Use other power source using Multi-Voltage AC Adapter or 12V DC Adapter. When the battery is completely discharged all indicators on the battery and compressor will extinguish and the compressor will shut off. Refer to Charging the Battery on page 23. 8. To remove the Battery from the PARI TREK Compressor, push and hold the Release Button down on the front of the Battery then slide the Battery forward and lift the compressor off the Battery. Refer to page 5 figure D. 9. To protect the Battery Connection from possible damage, attach the blue Removable Connection Cover to the bottom of the PARI TREK Compressor. Refer to page 5 figure D. 10. The Rechargeable Battery can not be recharged while it is attached to the PARI TREK Compressor. Refer to page 6 figure L.

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8. NEBULIZER NEBULIZER SET UP (Note: Nebulizer is not sterile) 1. Make sure the nebulizer has been cleaned and/or disinfected before first use and after last treatment of the day. Refer to the Cleaning and Disinfecting the Nebulizer section on pages 21 and 22. 2. Remove the Nebulizer Insert by twisting counter-clockwise until it stops and lift up. Refer to page 5 figure E. 3. Pour prescribed medication into Nebulizer Cup. Refer to page 5 figure F. Do not fill more than 8ml per treatment for PARI LC Plus® Reusable Nebulizer (or 6ml for PARI LC Star® Reusable Nebulizer). 4. Replace the Nebulizer Insert and make sure the semi-circle is facing the nebulizer outlet and the two circles should be next to one another. Refer to page 5 figure E. 5. If using an optional mask, attach the mask directly to the Nebulizer Outlet. Refer to page 6 figure G and H. NOTE: When using face mask, the Inspiratory Valve Cap must be either in place or removed depending on the type of mask. See chart for proper position. Refer to page 6 figure G & H.

Mask Type

Pediatric Rigid Aerosol Mask Adult Aerosol Mask Bubbles the Fish™ Pediatric Mask PARI Baby™ Size #0 Nebulizer Set PARI Baby™ Size #1 Nebulizer Set PARI Baby™ Size #2 Nebulizer Set PARI Baby™ Size #1 Mask Conversion Kit PARI Baby™ Size #2 Mask Conversion Kit PARI Baby™ Size #3 Mask Conversion Kit

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14F15-PP 14F20 44F7240 22F90 22F91 22F92 44F2401 44F2402 44F3301

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Remove Leave Inspiratory Inspiratory Valve Cap in Valve Cap place X X X X X X X X X

6. If using the Mouthpiece, attach the Mouthpiece to the Nebulizer Outlet with the Expiratory Valve facing up. Then attach the Inspiratory Valve Cap by pressing firmly into the Nebulizer Insert. The Inspiratory Valve Cap is designed to fit tightly. Refer to PARI Reusable Nebulizer Illustration on page 3 item 1. 7. Press one end of the tubing firmly onto the Air Outlet on the front of the PARI TREK Compressor. Refer to page 6 figure J. It is important that the tubing be pushed firmly all the way onto the Air Outlet of the PARI TREK Compressor. The tubing is designed to fit tightly. 8. Firmly press the other end of tubing onto the Air Intake on the bottom of the PARI Reusable Nebulizer. Refer to page 6 figure J. NEBULIZER TREATMENT 1. Take your treatment as directed by your physician. 2. The PARI Reusable Nebulizer has 2 valves that open and close during the nebulizer treatment when the Mouthpiece is used. These valves help to maximize aerosol delivery and minimize medication waste. 3. Sit in a relaxed, upright position and press the blue On/Off Switch (refer to page 2) once to turn on the PARI TREK Compressor. The Multi-Color Status Indicator on the front of the compressor will illuminate green. 4. Place the Mouthpiece on top of your tongue and close your lips around the Mouthpiece. Take slow deep breaths to inhale the aerosol medication slowly. Refer to page 6 figure K. As you inhale, the valve on the Inspiratory Valve Cap opens. 5. Exhale slowly through your mouth. As you exhale, the Expiratory Valve on the Mouthpiece opens, releasing your exhaled aerosol. At the same time, the Inspiratory Valve closes on the top of the nebulizer which reduces waste.

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6. If using a mask, place the mask over the nose and mouth and inhale and exhale slowly. 7. Continue steps 4 and 5 until the medication is gone or you hear a "sputtering". Press the blue On/Off Switch once to turn off the PARI TREK Compressor. If the Multi-Color Status Indicator (refer to page 2 item 6) on the front of the PARI TREK Compressor turns red and the compressor shuts off, then the PARI TREK Compressor has reached its temperature limit and automatically turned off to prevent damage to the PARI TREK Compressor. In the unlikely event this occurs, the PARI TREK Compressor will need approximately 30 minutes to cool down prior to resuming the treatment. Press the blue On/Off Switch once to turn off the PARI TREK Compressor and wait approximately 30 minutes for the PARI TREK Compressor to cool down before restarting the compressor. If the PARI TREK Compressor does not start please allow another few minutes for the compressor to cool and try again. NOTE: The PARI TREK Compressor will not automatically come back on once the unit has cooled down. TREATMENT TIMES: l

Patients who use a 2.5ml volume fill will typically find that the PARI TREK Compressor will deliver the treatment in less than 10 minutes. Treatment time depends upon breathing volume, patient’s age and disease state.

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The PARI TREK Compressor was designed for intermittent use to deliver aerosol medications, and not for continuous use humidification or prolonged treatments (not over 30 minutes at one time). The PARI TREK Compressor is equipped with a re-setable thermal protector to prevent damage to the PARI TREK Compressor unit. If the thermal protector cuts off, the PARI TREK Compressor will shut down until it is cool (approximately 30 minutes). Then treatments can continue.

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If you will be using the PARI TREK Compressor for treatments longer than 30 continuous minutes at one time, please contact PARI Patient Connection at 1.877.943.3931 (USA) then press 1 for tips on prolonged use.

CLEANING THE PARI REUSABLE NEBULIZER 1. Disconnect Tubing from Air Intake on the bottom of the Nebulizer Cup. Refer to page 6 figure J. 2. If there is any moisture (condensation) in the Tubing, let the PARI TREK Compressor run with only the Tubing attached for 2-3 minutes. The warm air from the PARI TREK Compressor will dry out the Tubing. Alternatively, you can dry the Tubing by removing it from the PARI TREK Compressor and hanging it up with the "ends down" to allow the moisture or condensation to drain out and evaporate. Use a clean damp cloth to wipe the exterior of the Tubing. 3. Disassemble the Reusable Nebulizer parts as illustrated on page 3. 4. Wash all Reusable Nebulizer parts with warm water and liquid dish soap. DO NOT WASH THE TUBING. 5. Rinse the Reusable Nebulizer parts thoroughly with warm water and shake out water. 6. Air dry or hand dry Reusable Nebulizer parts on a clean, lint free cloth. Reassemble Nebulizer when parts are dry and store. 7. You can also wash the Reusable Nebulizer parts in the top shelf of a dishwasher. Masks can not be washed safely in a dishwasher. DO NOT WASH THE TUBING. Place the Reusable Nebulizer parts in a dishwasher basket and place the basket on the top rack of the dishwasher. Remove and dry parts when the dishwasher cycle is complete.

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DISINFECTING AND STERILIZING THE PARI REUSABLE NEBULIZER 1. Clean the Reusable Nebulizer as described in Cleaning the Nebulizer section on page 21. Every other treatment day, soak the Reusable Nebulizer parts in a solution of 1 part distilled white vinegar and 3 parts hot tap water for 1 hour. DO NOT SOAK THE TUBING. You can substitute commercially available respiratory equipment disinfectant (i.e., Control III®) for distilled white vinegar by following manufacturer’s instructions for mixing. 2. Rinse all parts of the Reusable Nebulizer thoroughly with warm tap water and dry with a clean, lint-free cloth. Discard vinegar solution when disinfecting is complete. 3. Reusable Nebulizer parts (except Tubing and Mask) may also be sterilized by boiling them in a clean pot of water for a full 10 minutes. Hospitals and clinics can sterilize the Reusable Nebulizer parts (except Tubing and Mask) by autoclaving (a maximum of 277ºF or 126ºC) and following autoclave manufacturer’s instructions. Dry Reusable Nebulizer parts on a clean, lint-free cloth. CONTROL III® IS A REGISTERED TRADE MARK OF MARIL PRODUCTS, INC. THE PARI REUSABLE NEBULIZER INCLUDES A 6 MONTH LIMITED WARRANTY FOR HOME CARE USE.

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