Instructions for use of a Penn-Century MicroSprayer Aerosolizer - Model IA-1C and FMJ-250 High Pressure Syringe

Transcription

1 Penn-Century, Inc Queen Street Suite 200 Wyndmoor, PA USA Tel Fax Instructions for use of a Penn-Century MicroSprayer Aerosolizer - Model IA-1C and FMJ-250 High Pressure Syringe For doses of 25-μl to 250-μl in Mouse, Rat or Custom MicroSprayer /Syringe Assembly - MSA-250 Precise, hand-operated and air-free. The Penn-Century MicroSprayer Aerosolizer Model IA-1C and FMJ-250 High-Pressure Syringe are patented components of a hand-operated, intratracheal aerosol drug delivery system. Together, they produce a fine, highly concentrated, air-free mist from the end of a small-diameter delivery tube. They can successfully aerosolize a wide range of pharmaceutical, biologic, toxicologic and other liquids, solutions and suspensions. It can permit precise administration to the lungs, nasal cavities or other in vivo and in vitro applications. The devices are frequently used for analysis and testing of pulmonary drug delivery methods and inhalation and respiratory drugs and devices. The devices are made of stainless steel and other chemically resistant components and are sterilizable and reusable. They are available in two standard lengths, for intratracheal in vivo use in mouse or rat, or in any custom length (straight or with bend) for use in larger animals (guinea pig, rabbit, ferret, dog, sheep, cow, monkey, etc.) or custom in vitro applications. 1

2 Planning for use What you need to know Penn-Century intratracheal aerosol devices have a number of unique attributes that should be considered in your preparations for conducting research. Prior to use in an in vivo or in vitro model, users are responsible for determining the feasibility and safety of administering their particular formulation at the dose volume, composition and frequency they wish to use. In particular, researchers need to know the effect on their formula when it is aerosolized the ability to aerosolize the same formula repeatedly in the MicroSprayer Aerosolizer without clogging it, and the minimum and maximum dose levels that can be safely and effectively administered to the animal. For proper use for intratracheal drug administration, the Penn-Century MicroSprayer Aerosolizer - Model IA-1C and FMJ-250 Syringe require: Knowledge of the process for anesthetizing and intubating an animal Time to practice loading the syringe (Three methods are offered below.) Time to understand how to attach and use the precision dosing spacers provided with the syringe Time to practice use of the MicroSprayer and FMJ-250 Syringe with water only in the open air to observe the aerosol and to develop a sense of the rapidity and force you must use to create a uniform plume of aerosol Time to practice using the MicroSprayer intratracheally in the animal and develop a way to determine that the very tip of the MicroSprayer is directly above the carina, without touching the carina Time, if needed, to practice use of the device intratracheally with a colored liquid (dye such as Evans blue or Methylene blue), fluorescent or radio-opaque contrast material to verify that the very tip of the MicroSprayer Aerosolizer has been inserted properly in the trachea to assure optimal deposition and distribution in the lungs. Time to determine the optimal dose range for the particular animal model and drug formulation by increasing doses in small increments, if the range is not known A plan for the method or methods you will use to confirm deposition and distribution of your own drug or formulation in the lung. This may include use of dye, radio-opaque imaging or contrast agents, dissection and/or bronchoalveolar lavage. Important reminders The Penn-Century MicroSprayer Aerosolizer Model IA-1C is not a hollow needle, catheter or cannula. It is a patented, liquid-only, air-free atomizer device. It contains small patented components in the tip that help generate an aerosol when used with the FMJ-250 High Pressure Syringe. The passages through these components for the Model IA-1C are about 60 microns in diameter. When it is used to administer viscous formulations or solutions/suspensions, additional care must be taken to clean the MicroSprayer Aerosolizer according to our instructions to prevent agglomeration of suspended particle material in the tip that can block or clog it and interfere with performance. The Penn-Century MicroSprayer Aerosolizer is made of narrow, flexible, stainless steel tubing that can be easily bent. Care must be taken not to manipulate it or force it into a sharp bend or crease, as this will damage it beyond repair. 2

3 Air bubbles may sometimes form inside the FMJ-250 High Pressure Syringe that will affect the quality of the aerosol and must be purged or eliminated using the Air Purge Kit provided by Penn-Century, according our instructions. Correct placement in the trachea is essential. For obtaining the best results for intratracheal use, the placement of the very tip of the delivery tube is critical. In published studies, optimal lung deposition from Penn-Century intratracheal aerosol devices is obtained when the very tip is carefully positioned in the trachea so that the very tip is near to but not touching the carina (first bifurcation) of the anesthetized animal. If the tip of the MicroSprayer Aerosolizer is inserted only halfway down the trachea, it is possible that the aerosol will impact against the walls of the trachea, turn to large droplets and be coughed or swallowed. Cautions for intratracheal use in the animal. Use of all Penn-Century devices for intratracheal applications is essentially a form of intubation. Familiarity with intubation and anesthetized animal prep is a prerequisite for use of the devices. When using the any Penn-Century intratracheal aerosol device whether liquid or dry powder, the user must push the plunger of the syringe fast and with force to aerosolize the liquid inside. For optimal lung deposition, the tip of the delivery tube must be positioned near to, but not touching the carina. Therefore, the user must exercise care and attention to minimize any forward motion of the hand while pushing quickly and firmly on the plunger, to prevent trauma or injury to the animal. Intratracheal use of Penn-Century devices. For best results, position the tip of the device near to - but not touching the carina, or first bifurcation Tip of device Trachea Aerosol Carina 3

4 KEY FEATURES: MicroSprayer Aerosolizer (liquid) - Model IA-1C Requires FMJ-250 High Pressure Syringe The Penn-Century MicroSprayer Aerosolizer and FMJ-250 High Pressure Syringe are the only commercially available air-free intratracheal aerosol delivery technology. They can be used to administer precise doses of aerosol for intratracheal, intranasal or other in vivo or in vitro applications. The devices have been shown to successfully administer a wide range of pharmaceutical and biologic agents, as well as toxicological, bacterial and viral materials. The MicroSprayer Aerosolizer can administer liquids and liquid suspensions/solutions, including nanoparticle and microparticle solutions. The MicroSprayer Aerosolizer - Model IA-1C is made of flexible, 23-gage stainless steel tubing and other chemically resistant components, and is designed to be sterilized and reused. The MicroSprayer Aerosolizer does not have a luer hub. It can only be operated with Penn-Century s patented FMJ-250 High Pressure Syringe. Standard lengths of the device are typically made with a 120-degree bend to permit the user to keep their hand out of the line of sight when viewing the epiglottis. For intratracheal use, the length of portion that is inserted into the trachea is designed to reach from the incisors to above the carina. For use in mouse, the intratracheal portion is 1.25 after the bend. For use in rat, it is 2 after the bend. Custom lengths are available for straight, longer or shorter applications, and for insertion into the trachea or into the lung via an endotracheal tube or bronchoscope. For best results, and to avoid injury to the animal, the tip of the MicroSprayer Aerosolizer must be positioned so that the tip is near to but not touching the carina. Particle size range: Mass Median Diameter of µm (microns) NOTE: Particles analyzed with water using laser defraction method. The MicroSprayer Aerosolizer can be safely cleaned with hot water or any organic solvent, autoclave or ultrasonic cleaner, and most, but not all, disinfectants. It is meant to be sterilized and re-used. 4

5 KEY FEATURES: FMJ-250 High-Pressure Syringe Required for use with MicroSprayer Aerosolizer - Model IA-1C The Penn-Century FMJ-250 High-Pressure Syringe is air-free and hand-operated. When used with our patented MicroSprayer Aerosolizer - Model IA-1C, it can administer precise doses of aerosol for intratracheal, intranasal or other in vivo or in vitro applications. The FMJ-250 High-Pressure Syringe is made of stainless steel outer layer with a borosilicate glass liner, a PCTFE seal and other chemically resistant components, and designed to be sterilized and re-used. The syringe is designed for precise administration of aerosol doses from 25 to 250 microliters. It has a maximum capacity of 250 microliters. The syringe is opaque and has no external measurement marks. A set of dose volume spacers is provided with each to device to permit accurate measurements of doses of either 25 or 50 microliters, or combinations of those amounts. Each user receives a set of five 25-microliter spacers and five 50-microliter spacers. These volume spacers are attached to the plunger of the syringe, pushed tightly together and carefully removed one by one. The gap or space that remains defines one dose of that particular volume. In this way, multiple doses can be administered with one full syringe. The FMJ-250 High-Pressure Syringe can be cleaned with hot water or any organic solvent, autoclave or ultrasonic cleaner, and most disinfectants. (Avoid use of bleach.) It is meant to be sterilized and re-used. The screw thread of the FMJ-250 High-Pressure Syringe is not a luer fitting. However, standard dosing needles or hypodermic needles can be attached to it by means of a Luer Lock Adapter provided - for purposes of filling the syringe, if desired. The syringe should not be filled through the MicroSprayer Aerosolizer. 5

6 Determining the optimal dose range Direct aerosol administration to the lungs with a Penn-Century intratrachael device permits far more precise quantification of the delivered dose and far higher drug concentration than is possible with large nebulizer or exposure systems for animals that mix drug with compressed air that is blown - at high momentum - at the nose of the animal. The aerosol from the MicroSprayer Aerosolizer is gentle, air-free, low momentum, highly concentrated and precisely quantifiable. A review of literature citing Penn-Century devices indicates that they permit far more efficient administration of very small doses, as well as the ability to deliver far larger doses volumes than would be possible by animal nebulization/exposure/inhalation systems and more far more safely than liquid bolus/droplet instillation through a gavage needle, catheter or endotracheal tube. Researchers should take into consideration that the optimal, most effective dose range they can administer using a Penn-Century intratracheal drug delivery device may be an amount that is far smaller or far larger than is possible within the limitations of standard methods of pulmonary drug delivery in animal models. The user must conduct feasibility experiments to determine the optimal dose for their own formulation by increasing the dose in small increments to determine the minimum or maximum effective dose, and to plan for this process in their experimental design. Determining deposition Use of all Penn-Century devices for intratracheal applications is essentially a form of intubation. The user must insert the tip of the device gently down the trachea of the anesthetized animal, near to but not touching the carina. Particularly when working with small animals such as mice, some users may wish to practice on several test animals by spraying with dye or a fluorescent or radio-opaque contrast agent to determine if the tip of the MicroSprayer Aerosolizer was correctly positioned, and to determine if the test liquid was well-distributed in the lungs, or was mostly deposited in the trachea or swallowed. Penn- Century also makes several helpful accessories, including a Small Animal Laryngoscope and a Mouse Intubation Platform to help users quickly and easily visualize the epiglottis and correctly insert the tip of the MicroSprayer Aerosolizer for optimal results. Practice with dye or contrast materials: Some users have found it helpful when learning to correctly use the MicroSprayer Aerosolizer to practice with radio-opaque materials, such as Technicium 99m, fluorescent materials or dyes, such as Methylene blue dye or Evans blue dye. (We strongly discourage using India ink for this purpose, as it may contain carbon particulates or shellac that can clog the sprayer tip over time.) 6

7 How to fill the FMJ-250 High Pressure Syringe Method 1: Fill syringe directly Method 2: Use Air Purge Kit syringe Method 3: Attach Luer Lock Adapter and any standard needle A choice of three methods for loading. The full capacity of the FMJ-250 High Pressure Syringe is 250µl. Once it is filled, it can be used to administer multiple smaller doses, using the volume spacers provided. (See below). There are three standard methods for filling the device. NEVER load the syringe through the MicroSprayer Aerosolizer. NEVER insert a sharp object or needle into it, as this may scratch or damage the syringe seal or damage the white Teflon tip of the plunger. Depending on the material being used, you may use any of the following methods. Method 1: Remove the MicroSprayer Aerosolizer from the syringe and immerse the distal end of syringe into the solution to be delivered. Pull back on the plunger. Note: If you pull too far, the plunger will come all the way out. Method 2: Your FMJ-250 High Pressure Syringe comes with an Air Purge Kit that can be used to eliminate air bubbles that may become trapped inside the syringe. The 1 ml plastic syringe supplied with the kit can also be used to fill the FMJ-250 Syringe. This syringe comes with a soft dispensing tip (red) that can be attached to the plastic syringe and inserted into the distal end of the FMJ-250 Syringe to fill it. The red plastic tip is soft and will not scratch the seal of the FMJ- 250 syringe or the Teflon tip of the plunger. If this method is used, remove the plunger of the FMJ-250 syringe completely, hold it in an almost horizontal position with the distal end slightly higher, and begin to fill the device from the distal end until the liquid wells up as a bulge or meniscus at the proximal end. Then, gently insert the plunger into the proximal end. Remove the air purge syringe and attach the MicroSprayer. Method 3. You may fill the syringe from a sterile glass vial or other reservoir by attaching a hypodermic or blunt dosing needle to the FMJ-250 syringe. Note that the tip of the FMJ-250 Syringe does not have a standard luer fitting. If you wish to attach a needle with a standard luer screw thread to the FMJ-250 Syringe, you must first attach the red portion of the Luer Lock Adapter that was provided with your equipment to the FMJ-250 Syringe. Then, attach any standard hypodermic or blunt dosing needle to the black portion of the Luer Lock Adapter. Then, insert the tip of the needle directly into the test material, or through the septum of a glass drug container, and pull back on the plunger to fill the syringe fully. Remove both the needle and adapter after filling. Attach the MicroSprayer Aerosolizer. 7

8 NEVER FILL the FMJ-250 High Pressure Syringe through the MicroSprayer Aerosolizer as this may cause it to become blocked or clogged. Administering precise dose volumes: How to attach and use dose volume spacers Once it is filled, the FMJ-250 High Pressure Syringe can be used to administer precise multiple doses up to 250 microliters, in volumes of either 25μl or 50μl, or combinations of those (i.e. 75 or 50 microliters. NOTE: The maximum dose that can be safely and effectively administered intratracheally with a Penn-Century MicroSprayer Aerosolizer will depend on the potency of the formula that is administered. There is no universal answer to the question how much? It may be possible to safely and effectively administer far more - or far less of a given formula than would be feasible or possible with other modes of pulmonary administration. The FMJ-250 syringe has a total capacity of 250µl. Typical delivery volumes are 25µl and 50µl for mice and µl for rats. However, research with the devices has demonstrated a far broader range of possibilities than is safe or possible to administer using air-driven, nebulizer type modes of delivery or liquid droplet instillation methods. The researcher must do feasibility studies prior to administering their formula, to determine in small increments if necessary what is the safest and most effective dose. The study should examine: the effect on their formula when aerosolized the ability to aerosolize the same formula repeatedly in the MicroSprayer Aerosolizer without clogging it, and the minimum and maximum dose levels that can be administered. Attaching and using the dose volume spacers ( stops ) Each FMJ-250 High Pressure Syringe is supplied with a set of five 25-µl and five 50-µl dose volume spacers to precisely administer doses of those sizes or combinations of the two. Select the size of dose volume spacers you plan to use. 8

9 Attach dose volume spacers as desired to the plunger rod. Press tightly together against plunger handle. Remove one by one for precise individual aerosol doses. Attaching and using the dose volume spacers ( stops ) After filling the FMJ-250 syringe to capacity, pull the plunger upward until there is enough space to attach the appropriate spacers to the plunger rod. Note: If you pull too far, the plunger will come all the way out. This can cause air to enter the syringe. The volume spacers will snap onto the plunger rod with a clicking sound. When all spacers are attached, push down on the plunger firmly until the all the volume spacers are pushed together against the top of the syringe, with no gaps. Some test formula may be ejected as you do this. The system is now ready. To administer Dose #1, carefully remove the spacer or spacers closest to the thumb button of the plunger that equal the dose volume desired. BE CAREFUL NOT TO CHANGE THE POSITION OF THE PLUNGER. The gap or space that remains after the spacer is removed equals the volume of the dose. Push the plunger with quick, sharp, firm and fast motion to produce a uniform puff of aerosol spray. If the motion is too slow, you will produce only a stream. Then, remove the next spacer and repeat. In this way, a series of doses (for example, five 50 µl doses) can be delivered sequentially, one after the other, from one animal to the next, before the syringe needs to be refilled. Practice with water. It is best to practice use of the volume spacers with water to get a sense of the thumb pressure that is required. Pressure should be quick and firm not tentative, gradual or slow - to create a full plume of aerosol, especially at small volumes. Be mindful of air bubbles in the syringe. Particularly at small doses, any air bubbles trapped in the syringe when it was filled will impair performance. When you practice using the device, if you observe small, hair-like streaks in the aerosol, or you have difficulty administering smaller doses without streaming, this may indicate that there are air bubbles that are trapped in the syringe that must be forced out or purged. 9

10 Removing air bubbles from the syringe. The Penn-Century MicroSprayer Aerosolizer is an air-free aerosol system. Air bubbles may on occasion become attracted to the hydrophobic Teflon tip of the plunger in the FMJ-250 syringe while you are filling it causing the quality of the spray to degrade. You may observe tiny lines or streams of liquid in it. In order to deliver discrete sprays of small doses (no streaming at the beginning or end of the spray cycle), the FMJ-250 syringe must be completely free of air bubbles. This can be determined by testing the device before use with water or with the solution to be used. If the spray quality indicates the presence of air bubbles, they can be eliminated by using the special Air Purge Kit provided. This kit has a soft tip that will not scratch the Teflon tip of the plunger. Purging air from the syringe: Be sure all liquid is removed from the empty syringe barrel before proceeding. This can be accomplished by removing the plunger and blowing a small amount of compressed air through the FMJ-250 Syringe. It should be possible to see clearly from one end to the other when holding it to the light. Find and fill your Air Purge Kit. Attach the special plastic (polypropylene) dispensing tip (red plastic) to the plastic 1 cc syringe and fill the assembly with test formula or water, being sure to eliminate all air bubbles from the plastic syringe. Remove the MicroSprayer Aerosolizer from the FMJ-250 Syringe, and pull back the plunger to a distance about equal to the length of the white dispensing tip. Insert the white dispensing tip into the open end of the FMJ-250 syringe until the needle touches the Teflon plunger tip. Then begin to fill the FMJ-250 Syringe from the plastic syringe, as shown (above right) while slowly withdrawing the plastic syringe. Continue to push on the plastic syringe as the needle is withdrawn, so that by the time the white dispensing tip is almost completely removed, you see a bulge of excess water has formed at the distal tip of the FMJ-250 Syringe. Be sure to fill the FMJ-250 Syringe with sufficient liquid so that there are no air pockets when the plunger is pushed in. Now, set aside the plastic Air Purge syringe, and immerse the distal tip of the FMJ-250 Syringe the solution to be administered and fill the syringe to capacity. Attach the MicroSprayer Aerosolizer and the system is ready to operate. Another very effective way to rid the system of air bubbles is to remove the plunger from the FMJ- 250 barrel and, using the Air Purge syringe/needle (or similar arrangement), inject liquid into top or (proximal end) of the FMJ-250 barrel while holding the barrel in a horizontal position. A meniscus or curve on the surface of the liquid will appear at the mouth of the FMJ-250 barrel. If there is difficulty in getting the meniscus or bulge to appear, hold the FMJ-250 barrel so that the mouth (proximal end) is pointing slightly downward. Place a drop of your test formula or water on the FMJ- 250 Teflon plunger tip and bring the tip into contact with the meniscus. Push the plunger all the way in and proceed as above. 10

11 Clean and test the MicroSprayer Aerosolizer and FMJ-250 High Pressure Syringe with water after use. Then blow air to dry. Attach the protective caps and return to original boxes for storing. Care of MicroSprayer Aerosolizer The MicroSprayer Aerosolizer must be cleaned immediately and thoroughly after use to maintain it in good working condition. It consists of stainless steel and other chemically resistant components and can be subjected to any standard sterilization or autoclaving procedure: gas, liquid, wet, dry, heat, cold, dilute acids, dilute bases, etc. In addition, the MicroSprayer Aerosolizer can be heated as high as 500 degrees Fahrenheit. To avoid damage to the device, if you are uncertain about use of a particular method or material, PLEASE CONTACT US FIRST. It is essential to fully clean, test, dry and properly store your device after use to insure that it performs as it should. Solutions and suspensions used in the device are forced under pressure through patented atomizing components at the tip of the MicroSprayer Aerosolizer. Over time, if the device is not fully flushed out and cleaned after use, there may be a build-up of residual material that hardens and clogs the tip. To minimize clogging, solutions should be filtered before spraying. In addition, reasonable care should be taken to avoid dust and dirt which can foul the sprayer tip. For instance, when placing the assembled system or individual components on a surface, it is best to avoid surfaces from which the device might pick up dirt or lint. A large, clean Petri dish works well for this purpose. ALWAYS clean and fully flush the MicroSprayer Aerosolizer after use with very hot distilled or filtered water. You may also use any organic solvent, such as ethanol, xylene or acetone to dissolve any materials that may be inside. The following are also safe for cleaning and disinfecting the device: Cidex, Cidex Plus, Cidex OPA, Enzol Solutions. If you wish, you can soak the devices in any of these as well, to soften any material that has become hardened in it, and then flush it out with the same solution using the syringe. You may fill the syringe with solvent and spray it into an enclosed container. (ALWAYS USE CAUTION WHEN SPRAYING ANY SOLVENT OR HAZARDOUS CLEANING AGENT TO FOLLOW SAFETY INFORMATION PROVIDED AND AVOID CONTACT OF THE SPRAYE WITH EYES, FACE OR SKIN. The MicroSprayer Aerosolizer may also be cleaned with ultrasound (sonicated) or autoclaved at standard sterilization temperatures. Is best to avoid cleaning the device with undiluted acid or base solutions, or bleach (Clorox /Clidox ), as these can be corrosive. 11

12 ALWAYS test the MicroSprayer Aerosolizer with water after cleaning it and before storing it to observe that it continues to deliver a full, uniform plume of spray that is as good as its operation when new. ALWAYS blow air through the MicroSprayer Aerosolizer fully before storing to eliminate remaining liquid inside. Direct a small stream of compressed air into the threaded sprayer hub of the MicroSprayer Aerosolizer until all fluid remaining in the sprayer tip is expelled. Products such as DUST-OFF or similar for cleaning computer keyboards are also suitable. Do not blow compressed air through the device without testing it first with water. If it is partly clogged, drying it with air will may further harden any material in the tip. ALWAYS clean the protective plastic end cap that came with the MicroSprayer Aerosolizer and screw it back on before storing it to remove any dust or grit that has gotten on it Always store the MicroSprayer Aerosolizer and FMJ-250 Syringe in the original boxes in which they were shipped to prevent it from getting dropped or bent. What to do if MicroSprayer Aerosolizer becomes blocked or clogged If the sprayer tip starts to clog, you will notice an increase in the force required to depress the syringe plunger. In general, it does not help at this point to increase the force on the plunger as this may only serve to further drive the offending material into the small passages of the sprayer tip. If this occurs: 1. Place the assembled sprayer tip in very hot dionized or distilled or filtered water, or soak in organic solvent and draw back on the syringe plunger, holding it in the fully retracted position for 15 seconds. Then unscrew the MicroSprayer Aerosolizer from the FMJ-250 Syringe, eject the contents of the syringe and flush it thoroughly with water. Repeat. 2. Ultrasound combined with an organic solvent, or an enzymatic cleaner such as Enzol may also help break apart clogged particulates in the tip. 3. If that doesn t work, and the MicroSprayer Aerosolizer is completely blocked and is not letting any liquid pass through at all, contact Penn-Century, Inc. for additional recommendations. Care of the FMJ-250 High Pressure Syringe The FMJ-250 High-Pressure Syringe is made of stainless steel outer layer with a borosilicate glass liner, a PCTFE seal and other chemically resistant components, and designed to be sterilized and re-used. NOTE: The FMJ-250 High Pressure Syringe is very durable and will withstand normal use. Inside the borosilicate glass liner (bore) inside the syringe that can crack, however, if the syringe is subjected to temperatures higher than standard autoclave temperatures, or to sudden temperature contrasts, or is dropped on the floor or forcefully strikes a hard surface. If so, the syringe may leak or the plunger may no longer move smoothly up and down in the glass bore of the syringe. If the glass liner is cracked, the syringe will not function properly and the device will not be repairable. Cleaning methods: The syringe can be sterilized to with standard materials. Sterilization with standard cold liquids is usually sufficient. The following are also safe for cleaning and disinfecting the device: Cidex, Cidex Plus, Cidex OPA, Enzol Solutions 12

13 The thumb button of the plunger is made of anodized aluminum. The syringe and plunger should never be soaked in bleach (Clorox or Clidox ) as this may cause permanent corrosion and/or staining. The FMJ-250 High Pressure Syringe can be autoclaved. It should not be heated above standard autoclave temperatures of degrees Centigrade. The FMJ-250 High Pressure Syringe may also be cleaned with organic solvents, very hot water, or sonicated. Always dry the syringe, put the protective the black end cap on the device before storing and in the original protective plastic box provided on shipment. Replacement plungers for FMJ-250 High Pressure Syringe After long use or from over-pressuring the system, the white Teflon tip of the syringe plunger may become worn. One symptom of this is that the syringe may leak from its proximal end (around the plunger rod). If this happens, a replacement plunger may be purchased from Penn-Century, Inc. without having to replace the entire syringe. Contact us for details. ALWAYS test both devices with water if they have been stored and not used for a long period of time. For a full summary of the company s repair and warranty policies, please review the Penn-Century Terms and Conditions. As manufacturers, Penn-Century, Inc. can offer: Product knowledge Operation of our devices Familiarity with published studies related to use of the same device and, if possible, similar drugs Familiarity with customer feedback about them These instructions and photos are the property of the Penn-Century, Inc. They must be not be reproduced without the written consent of Penn-Century, Inc. IMPORTANT NOTICE: Requirements for references to Penn-Century devices in publications, abstracts and presentations As a condition of sale, the Buyer agrees that upon publication or presentation of any research conducted using a Product, the Penn-Century name as the manufacturer ("Penn-Century. Inc. Wyndmoor, PA") and the name of the Products must be correctly spelled and cited, and include Penn-Century s registered trademark and model number as follows and as applicable: MicroSprayer Aerosolizer Model, FMJ-250 High Pressure Syringe, Dry Powder Insufflator - Model or Small Animal Laryngoscope Model LS-2. A breach of this section shall result in immediate harm to Penn-Century, and in addition to any and all rights available to Penn-Century, Penn-Century shall be entitled to an injunction or other equitable relief as a remedy for such breach. For any questions, contact us at Penn-Century, Inc. info@penncentury.com or Rev. 14Nov