# Alaska Airlines — Hazardous Materials Safety Interpretation - **operation:** document - **citation:** 00-0206 - **title:** Alaska Airlines — Hazardous Materials Safety Interpretation - **source type:** guidance - **agency:** Pipeline and Hazardous Materials Safety Administration - **status:** guidance - **official:** true - **published on:** 2000-12-13 - **effective on:** Not available - **summary:** 00-0206 response to Alaska Airlines concerning 175.10. - **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-00-0206.json - **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-00-0206.md - **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-00-0206 - **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2000/000206.pdf **body:** <<>> U.S. Department of Transportation 400 Seventh St., S.W. Washington, D.C. 20590 Research and DEC 1 3 2000 Special Programs Administration Ms. Marilyn Dirkx . Reference No.: 00-0206 Manager, Dangerous Goods Compliance Alaska Airlines Box 68900 Seattle, WA 98168-0900 Dear Ms. Dirkx: This is in response to your July 24, 2000 letter concerning certain carbon dioxide cylinders that are used in a medical device to administer needle-free injections. Specifically, you asked if the cylinders may be carried on board a passenger aircraft in checked or carry-on luggage under the exception in § 175.10(a)(4)(i), 175.10(a)(18) or § 175.10(a)(25) of the Hazardous Materials Regulations (49 CFR Parts 171-180). I apologize for the delay and any inconvenience it may have caused. Based on our review of information provided by a manufacturer of these medical devices, it is our opinion that the cylinders may be carried aboard passenger-carrying aircraft in checked or carry-on luggage under the provision in § 175.10(a)(4)(i). The devices do not qualify for the exceptions in §§ 175.10(a)(18) and 175.10(a)(25). The Federal Aviation Administration is in agreement with this position. Should you have further questions, please contact this office. Sincerely, idward T. Mazzull Director, Office of Hazardous Materials Standards <<>> JUL. 24.2000 10: 35AM ALASKA AIRLINES NO.169 P.2/2 - Allayka Airlines corbin U.S. Department of Transportation 8 175.10 Research and Special Programs Administration Office of Hazardous Materials Standards 06 - 0206 400 Seventh St SW Washington, DC 20590 Attn: Mr. Ed Mazzullo July 24, 2000 Dear Mr. Mazzullo: Recently, a passenger attempted to carry in his checked luggage two small carbon dioxide cylinders used for administering medical injections. They were discovered during CIX screening. (The CT, is an explosive detection x-ray! system that has been instrumental in detecting undeclared hazardous materials.) The screener advised the passenger that the çylinders could not be carried in luggage, and the passenger was forced to remove them from his luggage. The passenger, a physician, was very irritated, and stated that these small carbon dioxide cylinders are very common and that people are carrying them around all the time. According to the supervisor who responded to the call by the CIX operator, the cylinders were smaller than theitype used in live vests that arę approved for carriage by 49CFR 175.10(a) (25). My question to you is this: May small carbori dioxide cylinders used for the administration of medical injections be cartied onboard or transported in checked luggage as permitted in 175.10(a) (25), or 175.10(a)(18), or can they be considered medicinal and allowed per 175.10(a)(4)(i)? Thank you for your response. Sincerely, marily Marilyn Dirlex Manager, Dangerous Goods Compliance Tel 206-431-7442 Fax 206-433-3225 BOX 68900 SEATILE WA +8168-09001206-433-3200 <<>> JUL. 24.2000 10: 35AM ALASKA AIRLINES 1 NO. 169| P.1/2 ..i. Fi== To: Mr. Ed Mazzullo J.S. Department of Transportation Research and Special Programs Administratior Office of Hazardous Materials Standards Fax number 202-366-3012 From: Marilyn Dirkx Manager, Dangerous Goods Compliance Alaska Airlines Fax number 206-433-3225 Tel number 206-431-7442 Pages: 2 including this cover. <<>> Atten is the sen ere. me the bale I Do not see that this intent per hat then person and use - om A 1-- AcTina AÁfor HMS... 10-18-00 <<>> # 11/02/00 T#U 11:40 FAX 803 620 6431 BIOJECT Ø001 MEMORANDUM BOJECT - To: Gigi Corbin U.S. Department of Transportation RSPA/DHM-12/ Room 8422 400 Seventh Street, SW FAX: (SO9) E2X 5002 WWW.BIOJECT.CCM Washington, DC 20590-0001 From: Jim Bonicatto Date: 01 November 2000 Cc: Tom Brooks Subject: Bioject Inc. Part No. 1C08010, 8 gram CO, Gas Cartridge(s) mentioned 8 gram CO2 gas cartridge (cylinder) for use with the Biojector® Needle Free Injection This memorandum along with the attached data (2 pages) serves to address the above Management System. The cylinders are filled with 8 grams of CO2 and sealed. Once sealed in an enclosed, constant and attachments show the relationship of temperature and pressure. It must also be noted that rolume, the gas pressure is related to the temperature of the environment. The following table the minimum burst pressure of the cylinders is rated at over 6000 psi. This provides sufficient margin for product delivered and stored at normal temperatures. Summary of Pressure vs. Temperature: Temperature (E) 32 Pressure (psi) 68 506 88 1071 831 140 3190 If there any further questions please feel free to contact myself (503) 639-7221 x417 or Tom Brooks (X437). Regards, R&D Manager Jim Bonicatto <<>> $ 11/02/00 THU 11:41 FAX 503 620 6431 BIOJECT 41003 iSi INDUSTRIAL PRODUCTS PRODUCT INFORMATION STANDARDS .... Product Range FLLNG......H -emmer EN. DIN, TUV, DOT, MOD, ES. MIL, FAA, TSO. ASTA. EMPA, DAN Mutiply Converton Foctors • Carban Doxice (COa, Narogen (Na) SURFACE TREATMENT... Eechroplated Zing, Super (high corsion resistant) Zac MMI MARKING... Solact from toble below. Other sees, goses and filings on request. Ink le1, Engraving or Printing to specticion Nominal Weights orcas CopociTy Water Diameter Body • Overall crOms ml Lengm Neck datalis 8 10.5 & 12 10 10 & 1T.5 15 665 . 82,5 • 3/8°×24 UNF 1A 12 • 14 82.5 3.7 mm Die PLAW 21 82.5 3/8 x 24 UNFA 16 21 88.5 73mm CYa PLAIN US gason 21 89,5 9.7 mm DkI PLAN UX cotton US thic cusco 29.57 Fres 16 32 38.5 8.9 mm Da PLAIN ml 20.23 & 24 105 3/8° X24 UNF 1A/2A 28 40 40 760 1/2° x20 UNFlA 14.5 psi = Conversic 28 3.5 mm Dia PlAIN Bart 28,30 & 33 45 160 52 • 139 3/9° X2A UNFlA/ 35 & 38 1/2 × 20 UNFA 45 178 FOR VARIOUS FLING DENSILES OF COZ PRESSURE - TEMPERATURE 55 3 20 85 138 1/2 ×20 UNF TA filing density = "Water copochy crad Wt of COs (a) 75 103 163 189 1220 F A 81 86 115 1/25 × 20 UNF TA 120 145 1/2°=20 UNFIA 200- 210 198 10230UF 1A (3180psh) 120° & 135° 210 176 171 1/2x20LNF1A 400 Maso 120, 735 & 150 215 300 1/2° = 20 UNF 1A 230° 350 226 1/2 × 20 UNFTA 450 275 300 1D,08s 290° 1/2° x 20 UNF lA 295 400 225 1/2° x20 UNF lA 915 440 215 1/2×20 UNF lA 330° 500 311 1/2° ×20 UNFA 345 525 375 1/2 ×20 UNF TA 450 600 265 1/2° ×20 UNF TA 460° 700 311 368 1/2 X2 UNFA • DOT Approved. Produet range may be updaled, Please check with us. 1/2 × 20 UME 1A TEMPERATURÉ CCT → : 40 6c 80 120 180 Physical Characteristics Odour Carbon Dioxide (CO2) Taste • Stightty pungent Niltogen (N» Fire hazard Acidic/Biting None Toxicity Non-lammable None Liquid density (20°C) Mox. 0.5% V/V continuous Nor-itammable Incroncihe 1140 ana yan un-s 0.775 kg Non-toxic <<>> 11/02/00 THU 11:41 FAX 503 620 6431 BIOJECT Q002 Carbon Dioxide 291 Iesap Pressure Voluzac cu {t/1b (Densityl | lb/cu /t Enthalpyan Entropy= E Solid Solid Solid paia paig Vagor Liquid Ilquid Vapor Liquid vapor -6 276.3 + .-2 285.8 261.6 295.7 271.1 0.3233 2 316.3 305.8 281.0 0.3010 0.3119 64. 62 193.0 63.63 63.96 194.9 193.9 * 316.01 315-99 0.6979 0. 7000 10.9691 315.95 0.9678 291.1 6 327.0 10 8 337.9 : 301.6 0,2805 0.2906 63.30 196.9 195. 8 315.92 0.7043 | 0.9654 0.7022 | 0.9666 312.3 349.0 323.2 0.2707 360.5 334.3 0.2523 0.2613 62.97 198.0 315.83 315.88 10.7085 0.7064 0.9642 62.50 200.0 198.9 315.760-7106 0.9629 315.68 0.7127 0.9603 10.9616 345.8 w N 369.6 357.5 0.2353 0.2436 61.99 61.69 315,50 315.59 0. 7169 | 0.9575 0.72+8 10.9589 409- 196 381.8 0.2273 394.3 0.2196 61.32 61:02 204.2 315.40 315.27 0.7190 0.7211/0.9547 0.9561 20 42I.9 407.2 0. 2122 60.32 60.67 21 $35.1 420-4 0,2050 206.3 205.2 315.13 314.96 0.7253 0.7232 0.9533 28 26 462.5 448.7 434.0 0.1980 461.9 417.8 0.I911 59.57 59.91 208.4 207.4 314.80 0.7275 0.9520 314.62 0.7297 0.9493 0.9507 476.6 0.1845 59.17 $ 30 Va •32 490.8 490.8 476.1 0. 1783 58.78 210.6 209.S 314.42 314,19 0.7341 0.7319 0.9479 34 505.5 0. 1722 58.02 58.40 211.7 313.90 0. 7363 0.9465 and 36 520.5 sos, 8. 0.1663 214.0 212.8 313.58 0.9450 38 551.7 $36.0 521.3 0.1602 0.2482 0.1542 57.59 313.20 0. 7385 0.7407 0.9434 57. IZ 216.4 215.1 312.77 0.7429 0.9399 0.9417 567.7 553.0 537.0 0.1425 $6.70 LI •44 584.0 569.3 0. 1372 56.29 217.4 311-76 312.23 0.7452 0.7475 0,9380 600.8 0.1273 0.1321 55.89 218.7 311.20 0.7598 0. 9360 46 617.8 586. 1 55.44 222.5 221.2 220.0 310.63 0. 7521 D.9340 310.05 0.7544 0.9321 SO 48 635.2 603.1 638,2 620.5 0. 1226 54.95 309.47 0.7568 0.9302 52 652.9 0.1138 0. 1281 53.91 54.43 54 671.2 223.7 308.90 0.7593 0. 9283 56 708.6 689.7 656.5 675,0 0.1095 $3. +5 226.4 225.0 308.32 0.7618 0.9264 713.2 693.9 0.1054 52.95 307.75 0. 7643 0.9227 0.9246 727.9 0. 09752 0. 1014 S1.81 52.37 227.7 62 767.7 747.6 230.6 229.1 307.13 306.49 D. 7694 0. 7668 0. 9187 0.9207 732.9 753.0 0.08999 0. 09372 51.17 66 64 788.3 773.6 49.78 50.47 233.5 232.0 305.03 305.78 0.7746 0. 7720 0.9166 304.22 0. 7773 0.9145 68 809.3 "то 852.7 830.8 794.6 838.0 816.1 0.08631 0.07894 0.08261 $9.03 236.7 235.1 303.35 0. 7801 0. 9123 47.62 48.39 302.45 0. 7830 0. 9100 72 74 875.0 238.3 301.52 0.7861 0.9053 0.9077 76 897.8 883.1 860.3 0.07535 0.06811 0. 07173 46.80 242.1 240.3 300.51 299.39 0.7894 0. 7930 O.9030 78 945.1 921.1 906-4 45.90 930.4 0.06013 0. 06411 44.94 244.3 298.10 0.7970 0.9006 82 80 969.5 979.3 954.8 42.67 43.90 248.9 246.4 296.57 0. 8013 0. 8982 294.75 0. 8060 0.892% 0. 8957 un i 84 1020 994.5 1031 1005 0.05171 0.05603 39.59 41.23 251.5 86 87.9 | 1071 1046 254.7 292.46 289.67 0. 8112 0.8170 0.3881 1056 0. 04711 0. 03423 29.21 37.03 272.7 259.0 285.64 0. 8249 0. 8737 0. 8821 272.70 0.8483 0. 8483 **Based on 0 for the perfect cryatal at absolute zero of temporature, -459.67F (-273.15C) <<>> AUG-Ø1-2000 15:24 HMIC P.Ø1/Ø1 • TO: Tom Brooks Date: Aug. 1, 2000 FAX: (503) 624-9002 RE: Product Specs for Biojector 2000 and similar devices Send to: Gigi Corbin U.S. Department of Transportation RSPA/DHM-12/ Room 8422 400 Seventh Street, SW Washington, DC 20590-0001 (202) 366-4465 Thanks. GIGI- THAnKS FOR QOUR CALL; THIS IS THE IntO TO Den @THE FAA. 175.10.41, Looks GooDs, I ALsO THOUGHT 175,10. AiV WAS InTERESTING ALSO. I'l be walting far our next DISCUSSIOn, AS THIS IS CRITICAL TO OUR Business. THEs AGAIN - Tom TOTAL P.Ø1 <<>> TO: Tom Brooks Date: Aug. 1, 2000 FAX: (503) 624-9002 RE: Product Specs for Biojector 2000 and similar devices Send to: Gigi Corbin U.S. Department of Transportation RSPA/DHM-12/ Room 8422 400 Seventh Street, SW Washington, DC 20590-0001 (202) 366-4465 Thanks. <<>> : $ =F ***************-COMM. JOURNAL- ******************* DATE AUG-01-2000 ***** TIME 15:24 *** P.01 MODE = MEMORY TRANSMISSION START-AUG-Ø1 15:23 END-AUG-Ø1 15:24 FILE NO.* 091 STN NO. COM ABER NO. STATION NAME/TEL. NO. PAGES DURATION 001 OK 915036249002 001/001 00:08'20" -HMIC - ********************************-2023653012 -***** - -******** • TO: Tom Brooks Date: Aug. 1, 2000 FAX: (503) 624-9002 RE: Product Specs for Biojector 2000 and similar devices Send to: • Gigi Corbin RSPA/DHM-12/ Room 8422 U.S. Department of Transportation 400 Seventh Street, SW Washington, DC 20590-0001 (202) 366-4465 Thanks. <<>> Welcome to the Future of Needle-free Technology http://www.biojcct.com/ Welcome to the Future of Needle-free Technology Download the 1999 Annual • hila Report format. If you are unable to read pdf The 1999 Annual Report is in pdf files, then click on the Adobe Acrobat logo, and download Adobe Acrobat Reader. UCIN TUV Get Acrobat® & Reader d What's New 150 G 5001 Bioject Closes $10 Million in Equity Financing Go! Commitment to Performance Through the commitment of each employee, the Bioject team will deliver requirements and raise community awareness of safe, effective, needle-free quality products and responsive services which meet or exceed customer injection technology. healthcare industry threatening the well being of medical professionals and Contaminated needlestick injuries take an enormous toll on today's costing health care providers millions of dollars annually. Now there is an effective needle-free drug delivery method for subcutaneous and the subsequent spread of bloodborne pathogens. Because it is easy to and intramuscular injections that prevents contaminated needlestick injuries injections. use and patient preferred, it marks a new standard of care for administering The Biojector 2000 Needle-Free Injection Management System delivers compressed carbon dioxide (CO,) as a safe power source to inject medications parenterally without a needle. Instead, the Biojector uses action effectively penetrates the skin and delivers the medication into the medication through a micro-orifice within a fraction of a second. This delivery patients's tissue. cross-contamination with its unique, patented, disposable medication syringe. The Biojector eliminates costly maintenance and the threat of Once an injection is given, the needle-free syringe is discarded. Single-use delivery for medical professionals, advancing the overall quality of healthcare. Bioject syringes provide safe injections for patients and needle-free drug 1 of2 7/28/00 3:52 PM <<>> Welcome to, the Future of Needle-free Technology http://www.bioject.com/ Send Comments About The Web Site To: BROJECT Call: 800.683.7221 www.Bioject.com H6S2H Customer Service 7620 SW Bridgeport Road customerservice@Bioject.Com E-Mail: Portland OR 97224 Injection Management Systems are trademarks of Bioject Inc. Last Biojector® is a registered trademark, and Bioject and Needle-Free updated: 28 July 2000 2 of 2 7/28/00 3:52 PM <<>> Biojector 2000 Description & Specifications http://www.bioject.com/Information/Product_Description/ ... Biojector 2000 Description & Specifications The System The Biojector is a high speed delivery system designed to inject medication intramuscularly (IM) or power source to eject mediation through a tiny orifice in a fraction of a second, effectively penetrating the subcutaneously (SC) without a needle. The Biojector employs compressed carbon dioxide (CO2) as skin. Energy Source The Biojector is energized by a standard CO2 cartridge. Each CO2 cartridge delivers an average of 10 injections with proper technique. Installing the CO2 cartridge is a simple procedure, which is described in the Instruction Manual. The CO2 does not interact with the medication. Sterile, Single-Use Biojector Syringe The Biojector is the first jet injector in history to delivery medications from a sterile single-use syringe. unique feature virtually eliminates the risk of bloodborne pathogen cross-contamination to patients and i his plastic syringe is the only part of the system that comes in contact with the patient's skin. This healthcare providers. Advances on Proven Technology Pneumatically powered injectors have been used for many years. Millions of injections have been given, proving that this technology is efficacious. Jet injectors were most widely used to immunize large numbers or people quickly and economically. All of these early devices injected through a stationary was learned that the stationary nozzle, through which the medication was ejected, could pass bloodborne nozzle, which required labor intensive rinsing, cleaning and sterilization for proper maintenance. Later, it pathogens from one patient to another. This cross-contamination problem has been eliminated by the B2000. Unique Design Several important design elements distinguish the Biojector from other jet injection devices. The Biojector removes the possibility of cross-contaminating patients through use of a disposable single-use syringe. After each injection, the old syringe is discarded and a new one is inserted for the next patient. Because of this design, sterilization and daily maintenance are not necessary. Needle-Free Injections into the syringe. The needle is then discarded and the filled syringe is inserted into the device. A sterile, The Biojector Syringe is packaged with a fill needle, which is only used to draw medication from a vial protective cap is provided to prevent touch contamination. This cap is placed over the filled syringe is placed firmly against the skin at a 90° angle, and the actuator is pressed and released to delivery the before the injection. After inserting the syringe into the injector, the protective cap is removed, the injector injection. Five different syringe sizes allow the clinician to achieve various penetration depths for an intramuscular or subcutaneous injection, depending on the patient's body size. The needle-free syringe eliminates "needlephobia" and reduces patient anxiety associated with injections. Many people seem to truly fear injections and may avoid seeking health care because of this phobia. Patient Preferred 1 of 2 7/28/00 3:56 PM <<>> Biojector 2000 Description & Specifications http://www.bioject.com/Information/Product_Description/ degrees or pain have been experienced with injections administered by both needle/syringe and jet Delivery of medication through the skin creates some physical sensation in nearly every case. Varying injection. Work with jet injectors shows that patient acceptance seems to be higher since the injection is reasons: It decreases the fear of a traditional needle injection. It appears less intimidating than the delivered more rapidly. (1,, Patients have preferred the Biojector over needle/syringe for the following traditional needle/syringe'. The injection occurs in a fraction of a second ) Local Site Reaction Depending upon the characteristics of the injectate, most people report little to no pain with a Biojector injection. Some drug preparations contain components that cause stinging, burning, aching or other painful reactions and this does not change with the Biojector. Bioject recommends that the medicatio package insert be read carefully so each patient can be advised of a medication's side effects. Product Specifications * Size: 8.5 inches (22 cm) * Weight: 20.5 ounces (580 grams) * Operation Temperature Range: < 60°-100°F (14°-38° C) * Power Source: CO2 Cartridge * Injections per CO2 Cartridge: 6 - 10 * Pressure Indicator: Yes * Syringe/Actuator Interlock: Yes * Recommended Service and Calibration Interval (for the Biojector): 18 months * Warranty: One Year * Administration: Intramuscular and subcutaneous under the direction of a physician To request product literature or to order products or training materials: BIOJECT Bioject Inc. Write: Call: 800/683-7221 Ext. 436 Home Page Customer Service 7620 SW Bridgeport Road E-Mail: Portland, OR 97224 customerservice@bioject.com Injection Management Systems are trademarks of Bioject Inc. Last Biojector® is a registered trademark, and Bioject and Needle-Free 2 of 2 7/28/00 3:56 PM <<>> http://www.bioject.com/faqs/ Frequently Asked Questions about the Biojector How does the Biojector work? The Biojector uses compressed gas (carbon dioxide) and sterile, disposable medication syringes to the power to deliver your medication. It never comes in contact with the medication or your skin. The deliver medication into the body's tissue without using a needle. The compressed gas simply provides actual injection is over in a fraction of a second. What does a Biojector injection feel like? explain if you should expect any of these reactions from the medication you are receiving. when injected. These are normal sensations and should go away in a short time. The doctor or nurse can What kinds of injections can be administered with the Biojector 2000? Intramuscular (IM) and subcutaneous (SC) injections can be administered with the Biojector 2000. How does the device administer the different depths of penetration? the number of syringe, the deeper the penetration of the injection. The size of the orifice, or hole, though which the medication is ejected varies by syringe size. The higher Can I buy a Biojector 2000 for home use? is important to be trained by a medical professional on how to administer injections with the B2000. Yes, but you must have a prescription from your physician. Using the Biojector is fairly simple, however it Is the Biojector 2000 covered by my insurance? You will need to contact your insurance company for information about medical device coverage. Some cover the entire cost, while others do not. What other products are available from Bioject? Besides the professional device, the B2000, Bioject also offers the disposable syringes and the compressed gas (CO2) cartridges. Is Bioject ISO 9000 Certified? • 9001 and EN 46001. Yes, Bioject received its ISO 9000 certification on January 28, 1999. Bioject is currently certified to ISO What is ISO 9000 and what does it mean to Bioject? 1 of2 7/28/00 4:09 PM <<>> Frequently Asked Questions about the Biojector http://www.bioject.com/faqs/ ISO certification is based on meeting a series of internationally accepted quality system standards ISO, from the Greek term "isos" meaning "equal," has been extrapolated by the standards organization developed by the International Organization for Standardization adopted in 1987 and revised in 1994. requirement and will help facilitate regulatory clearance requirements in Europe and other countries, mean an equal standard for quality system management. ISO 9000 has become an international ISO 9000 certification as a benchmark for quality systems. It also provides a structure to increase both thereby increasing sales. It is also a requirement of many US businesses that have come to recognize product and process quality and will help improve competitiveness, both in the United States and abroad. Is the Biojector approved by the FDA? lat the Biolector can be sold in the US nder FDAS regulations, the Bectr20 has been cleared for marketing in the USA. Which mear How much does the Biojector, syringes, and CO2 cartridges cost? customerservice@bioject.com anager to contact vou regarding pricin For additional information: BIOJECT Bioject Inc. Write: Call: 800/683-7221 Ext. 416 Home Page 7620 SW Bridgeport Road Customer Service customerservice@bioject.com E-Mail: Portland, OR 97224 Biojector® is a registered trademark, and Bioject and Needle-Free Injection Management Systems are trademarks of Bioject Inc. Last updated: 5/4/99 2 of 2 7/28/00 4:09 PM <<>> 8/2/00 Hattee - manufacturer du the Carboa dioxide Alidar useato administe, medications. and deterneie of this Coupe under 0(4))) Thawks-fee yeu Twes Gigi <<>> .* .. - BJOJECT HOJECT INC FACSIMILE TRANSMISSION COVER SHEET PCATUNO, CREGON 9724 FAX: (303) 0249002 TELEPHONE: (S03) aJ9-T22I Transmitting Fax Number: (503) 624-9002 • . Troubleshooting Number: (503) 639-7221 Date: 121/00 Receiving Far No: 326 - 2127 The following document consists of _12 page(s) including this cover sheet 2) Please call the troubleshooting number above if pages are not received. PLEASE DELIVER FHIS TRANSMISSION TO Name: Don S7:9483 Company: FAA Department: 1X32-mgs FEIS DOCUMENT IS EROM: Name: i chas Sport me Comments:® DOn, HEss is the tato Ws DiscussEDi Ass tha spres for your " Lits Incers? Rs4oo Richon THE ORIGINAL DOCUMENT BEING TRANSVIFIED: will not be sent to you - Will be sent by overnight mail will be sent by regular mail _ other:. CONFIDENTIALITY NOTICE: This facsimile [this page and any accompanying pages(s)] is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged, confidential and exempt from disclosure under applicable law. If the reader of this message is not the intended recipient or the employee or agent responsible for delivering the message to the intended recipient, you are hereby notified that the unauthorized dissemination, distribution, or copying of this communication, or the taking of any action in reliance on the contents of this information, is strictly prohibited. If you have received this facsimile in error, please notify Service. Thank you. us immediately by telephone (collect), and return the original message to us at the above address via the U.S. Postal <<>> A NEW ERA OF PARENTERAL THERAPY IS AT HAND He technongy Proven clicacy 7 Unique portable design • Easv to learn easy to use Contaminated needlestick injuries extract an enormous toll on today's ¡Safer cost-effedive healthcare industry threatening the well being of medical disposal professionals and costing healthcare providers millions of dollars annually. delivery method for subcutaneous and Now there is an effective needle-free drug LEGERTANC #Maintenance-free intramuscular injections that prevents contaminated needlestick injuries and the subsequent spread of bloodborne pathogens. Because it is easy to use and patient preferred, it Value added marks a new standard of care for administering cost-in-use injections. The Biojector 2000 Needle-Free Injection Management System delivers medications parenterally without a needle. Instead, the • Eliminates fear Biojector uses compressed carbon dioxide (COz) as a safe associated with needle power source to eject medication through a micro- injections 323" orifice within a fraction of a second. This delivery action effectively penetrates the skin and delivers the medication into the patient's tissue. The Biojector eliminates costly maintenance and the threat of cross-contamination with its unique, patented, disposable medication syringe. Once an injection is given, the needle-free syringe GÖLD 1293 BIOJECT is discarded. Single-use Bioject syringes provide safe injections for patients and needle-free drug delivery for medical professionals, advancing the overall quality of Safety. Innovation. Quality. healthcare. The future of needle-free drug delivery is here. <<>> PRODUCT INFORMATION Syringe No. Order No. Biojector 2000 Needle-Free Injector .. #1B02000 Biojector Syringes (Box of 100, up to 1.0 cc variable-dose) No. 2 Needle-Free Syringe #1S02100 No. 3 Needle-Free Syringe #1503100 No. 4 Needle-Free Syringe #1S04100 No. 5 Needle-Free Syringe #1S05100 No. 7 Needle-Free Syringe #1S07100 CO, Power Cartridges (Box of 10) #1CO8010 *#***** CUSTOMER SERVICE AND ORDERING INFORMATION Bioject is committed to providing the best possible service and • Orator Temperature Range support. Our customer service representatives are well qualified 6000380 and readily available to answer any of your questions regarding the Biojector 2000. o Weighte :230z. 640 grams! Contact Bioject Customer Service at: (800) 683-7221 ext. 436, or (503) 639-7221 ext. 436 cin, (22 cm) lo Or write: ressure Indicator: Bioject Inc. Customer Service 7620 SW Bridgeport Road Syringe Secured Indicator Portland, OR 97224 Inservice video tapes and educational materials are also available yringe Actuator Interlock upon request from Bioject's Customer Service Department. Recommended Service and Calibration In terv 18 months BioTector Warran One GOLD 1293 All sales are subject to Bioject's standard terms and conditions. Prices are subject to change without notice. 1. Leads from the MIMWR. Hepatitis B associated with jet gun injection-California. JAMA. 256(4): 446-447; July 1986. Biojector is a registered trademark, and Bioject and Needle-Free Injection subsidiary, Bioject Inc. Management System(s) are trademarks of Bioject Medical Technologies Inc. and its BIOJECT @Copyright 1994 Bioject Inc. All rights reserved. 171-0117-04, Rev. B, 3/96 Safety. Innovation. Quality. <<>> BIOJECTOR® 2000 Product information and benefits of the Biojector 2000 Needle-Free Injection Management System BIOJECT® Needle-Free Injection Management Systems <<>> CONTENTS DESCRIPTION The System. ..2 Energy Source ...2 Sterile, Single-Use Biojector Syringe. ...2 Advances on Proven Technology ..3 Unique Design .... Needle-Free Injections ..3 Patient Preferred •4 Local Reactions. .4 Customer Service .4 Product Specifications. .4 BENEFITS OF THE BIOJECTOR Healthcare Worker Benefits No Contaminated Needle: Safer for the Healthcare Worker Proven Efficacy. Easier Disposal Maintenance Free Cost Effective 5 Patient Benefits ..6 No Needle: Safer for the Patient. 6 No Needle: Patient Preferred .6 Faster and Easier Delivery ..6 Less Tissue Trauma .6 Biojector® is a registered trademark, and Bioject® and Needle-Free Injection Management REFERENCES 6 Systems are trademarks of Bioject Inc. <<>> DESCRIPTION 2 The System The Biojector is a high speed delivery system designed to inject medication intramuscularly (IM) or subcuraneously (SQ) without a needle. The Biojector mploys compressed carbon dioxide (CO,) as a power source to eject nedication through a tiny orifice in a fraction of a second, effectivel penetrating the skin. Biojector® Energy Source The Biojector is energized by a standard COr cartridge. Each COz cartridge delivers from 6-10 injections with proper technique. Installing the COr cartridge is a simple procedure, which is described in the Instruction Manual. The COz never interacts with the medication. Sterile, Single-Use Biojector Syringe single-use syringe. This plastic syringe is the only part of the system that comes in The Biojector is the first jet injector in history to deliver medications from a sterile contact with the patient's skin. This unique feature virtually eliminates the risk of bloodbore pathogen cross-contamination to patients and healthcare providers. -d-s <<>> DESCRIPTION Advances on Proven Technology athogens from one patient to another. This cross-contamination problem has bee ne stationary nozzle, through which the medication was ejected, could pass bloodborn eliminated by the B2000. Unique Design Several important design elements distinguish the Biojector from other jet injection devices. and daily maintenance are not necessary: Needle-Free Injections The Biojector Syringe is packaged with a fill needle or vial adapter which is only used before is emoted, lifer inter is placed ingle no che the cos at a roacie, and the actuator (switch) is pressed and released to deliver the injection. Five different syringe sizes allow the clinician to achieve various penetration depths for an intramuscular or subcutaneous injection, depending on desired depth of penetration. The needle-free syringe eliminates "needlephobia" and reduces patient anxiety associated with injections. Many people seem to truly fear injections and may avoid seeking health care because of this phobia. <<>> DESCRIPTION Patient Preferred every case. Varying degrees of pain have been experienced with injections administered Delivery of medication through the skin creates some physical sensation in nearly ceptance seems to be higher since the injection is delivered more rapidly' , both needle/syringe and jet injection. Work with jet injectors shows that patier Patients have preferred the Biojector over needle/syringe for the following reasons: • It decreases che fear of a traditional needle injection • The injection occurs in a fraction of a second • It appears less intimidating than the traditional needle/syringe injectior Local Reactions Customer Service Loger Customer ervice, - 683-72 01 305-69.121, akable upon request from Product Specifications Size: Weight ..8-1/2 inches (22cm) Power Souree:....... Operation Temperature Range ..20.5 ounces (580 grams) ..60°-100°F (14°-38°C) Injections per CO, Cartridge: GO, Cartridge Pressure Indicator: Syringe/ Actuator Interlock: Yes Recommended Service .Yes and Calibration Interval Warranty:.. (for the Biojector):. .18 months Administration:... Intramuscular and subcutaneous .12 months a physician injections under the direction of <<>> ... 5 BENEFITS OF THE BIOJECTOR Healthcare No Contaminated Needle: Safer for the Healthcare Worker Worker Benefits Proven Efficacy Selection Guide. Easier Disposal Maintenance Free he Biojector System is the only pneumatic device which employs a sterile terization or eating alet each usectors, the Biojector does not requir Cost Effective The cost to investigate and treat needlestick injuries has soared. A portion of these costs includes those with employee time loss, replacement, or medical treatment should the healthcare worker develop a positive test for hepatitis The Biojector eliminates the contaminated needle and removes the risk of associated with this benefit are measurable not only in direct costs, but also bloodborne pathogen transmission through accidental needlesticks. The savings in improved employee morale and productivity. <<>> BENEFITS OF THE BIOJECTOR 6 Patient No Needle: Safer for the Patient The liquid stream of medication takes the path of least resistance and flows Benefits around nerves and blood vessels rather than chrough them. The Biojector No Needle: Patient Preferred Faster and Easier Delivery The Biojector delivers a variable dose up to 1.0 cc in a fraction of a second. Less Tissue Trauma Published clinical studies report that there is less scarring, tissue trauma and atrophy hen medication (such as insulin) is delivered via jet injection as opposed to aditional needle/syringe REFERENCES 1. Nov. 1982. McKenzie R. Clinical applications of jet injection. NZM]. 720:815-817; 2. Hes So as tal, Tunition and mass therapy ease upon two decades xperience. Military Med. 516-524; June 1963 3. Neufeld P, Katz L. Comparative evaluation of three jet injectors for mass immunization. Can J Pub Hlth. 68:513-516; 1977. 4. method. JAMA. 195:156-159; 1966. Weller C, Linder M. Jet injection of insulin vs. the syringe and needle *12" <<>> BJOJECT® Needle-Free Injection Management Systems 7620 SW Bridgeport Road Portland, Oregon 97224 503/639-7221 800/683-7221 www.bioject.com Copyright© 1998 Bioject Inc. 171-0119-01 Rev. B (9/98) All Rights Reserved <<>> 07/21/00 FRI 11:45 FAA 503 620 6431 BIUJECT 40001 " "i ********************* *** ********************* IX REPORT *** TRANSMISSION OK IX/RX NO CONNECTION ID CONNECTION TEL 4105 18567517289p40 USAGE T ST. TIME 07/21 11:29 16'06 PGS. SENT RESULT OK 24 BJOJECT July 21, 2000 FAX: (503) 624-7002 TELEPHONE: (G03) 639-7221 WWW.BOJECT.CCM RE: Bioject Product Information Thanks for your inquiry regarding the Bioject Needle-Free Injection System. The Biojector® 2000 uses use of a needle. It is a safe, effective delivery method for subcutaneous and intramuscular injections. compressed carbon dioxide (COz) to deliver medication through a disposable, single-use syringe without the The features which differentiate our Biojector® 2000 system from other needle-free injection devices are: : Administers up to 1 ml. of injectate Delivers either subcutaneous or intramuscular injections, as indicated by the • Eliminates completely the risk of cross contamination between patients, and the risk of accidental medication/ vaccine labeling Administers different types of medication with the same device, using single use, needle- stick injuries for healthcare professionals • • Reduces the volume and expense of hazardous medical waste (sharps) disposal Ease of training and use for medical technicians and health care professionals High level of patient acceptance Extremely portable Addresses the sharps-safe issues raised by recent OSHA legislation. • Each Biojector 2000 Injector $675.00 • Each box of single use, sterlle, disposable needle-free syringes (100 SC or IM syringes per box) $67.00 • Each box of CO, power cartridges $5.00 (10 CO, cartridges per box) National Sales Manager, Mr. Kurt Lynam, at 503/639-7221 extension 501. If you would like to contact one of For additional information regarding ordering and pricing, please contact elther myself (Ext. 436), or our our nurses for additional clinical information please contact Tricia Diamond at extension 578. you need any additional information. Thanks again for your Interest in Bioject's products and technology. Please contact us at the number below if <<>> 10/18/00 WED 11:49 FAX 503 624 9002 BIOJECI INC. Ø1001 BIOJECT INC. FAX Date: 10-18-200 Number of pages including cover shes: 19 To: From: " 6161 CORDiN Tem BRooks - • Phone: Phone: (505) 639-7221 Fax phone: 202-366-3012 Fax phone: (503) 624-9002 CC: - REMARKS: Urgent • For your revier • Reply ASAP Please commem • BIOJECT 7620 S.W. BRIDGEPORT ROAD PORTLAND, OREGON 97224 <<>> 10/18/00 WED 11:49 FAX 503 624 9002 BIQJECE INC. 0002 INDUSTRIAL PRODUCTS PRODUCT INFORMATION Product Rango STANDARDS ........ ....... EN, DIN, TÚV, DOT. MOD. BS, MIL. FAA. TSO, ASTM, EMPA, DAN Conversion Factors FILLING Mutliply By To obtoin Carbon Dioxide (COz). Nitrogan (Na) SURFACE TREATMENT........ Electroplated Zinc. Super (high corrosion resistant) Zinc mm 0.0394 In am? MARKING........ 0.155 ..... InkJet. Engraving or Printing to specification cm° (1 ml) 0,061 in Seleot from table below, Other sizes, gases and fillings on request. Nominal Weight(s) of COa Copacity Water Diameter Body Length Overall Newton 0.225 • ibf rams mi mm mm Neck detalts 0.454 kg kg/am? bar 14.22 Ibf/in? 10 18 66.5 10.5 & 12 3/8° × 24 UNF 1A 14,5 Ibf/in? 10 & 11.5 19.6 82.5 8.7 mm Dia PLAIN atmosphere 1.013 N/mm? 145 bar 18.6 82.5 12 18.6 3/8° × 24 UNF 1A 16 82.5 7.3 mm Dia PLAIN US gallon 3.785 litres 22 88.5 8.7mm Dia PLAIN UK gallon 4.546 Hitres 16 16 22 8B.5 22 B8.5 8,9 mm Dia PLAIN US fluid ounce 29.57 • ml 20.23 & 24 3/8" × 24 UNF 1AV2A 28 254 105 20.7 1/2" × 20 UNF-TA: 28 160 8.7 mm Dia PLAIN 28, 30 & 33 20.7 160 3/8° × 24 UNF 1A 25.4 139 35 & 38 1/2° × 20 UNF 1A FOR VARIOUS FILLING DENSMES OF CO PRESSURE - TEMPERATURE 30 118 1/2° × 20 UNF 1A 45 30 55 & 60 138 1/2° x 20 UNF 1A Hing densily Water copacity (mil) Wt of CO2 (g) 75 31.8 163 1/2° × 20 UNF 1A 31.8 B4 189 1/2° × 20 UNFIA 600 / 0.00/0.251 41.3 86 145 35 1/2°x 20 UNF IA Made 120' & 135° 198 1/2" × 20 UNFIA 400 10.60 50 176 120, 135 & 150 1/2" × 20 UNF 1A 50 171 215 1/2° × 20 UNF 1A 226 1/2° × 20 UNF IA 50 275 1/2° × 20 UNF 1A 300 DABE 230* 290° 60 296 225 1/2" × 20 UNF IA 60 213 1/2° × 20 UNG \A 200 315 50 330° 311 1/2° × 20 UNF 1A 60 50 375 1/2° × 20 UNFIA 345 60 265 1/2° x 20 UNF 1A 100 450 311 460° 1/2° × 20 UNF 1A 60 368 1/2°x20 UNF IA Product range may be updated. Please cheok with us. TEMPERATURE (C) → 120 160 Physical Characteristics Carbon Dioxide (COz) Odour Nitrogen (N2) Slightly pungent Taste None Acidic/Biting None Fire hazard Non-flammable Non-flammable Toxicity Iquid densily (20°C) Max. 0.5% v/v continuous Non-toxic 0.775 kg/l Gas density (15°C and 100 KPa) - 1.85 kg/m (g/D 1.17 kg/m (g/l <<>> 10/18/00 WED 11:50 FAX 503 624 9002 BIOJECI INC. • har. AUG 17 '98 17:14 FR ISI NORTH AMERICA 973 227 9140 TO 15036249802 @003 AMS AEMUUAMAIAN →97 L5: UJA P.02 : 8 GRAM CO, (E) 8.7mm PLAIN NECK ARTICLE No: YH1 J • B8.7=5.05 27.3000 82.5' PIERCING ASEA LITHIN 0.3 ASOVE DA BELO HIS SURFID NẸT WEIGHT PULLGEW!CHT COZ POIDS DE REMPLISSAGE EN CO 8:0.3G- VOLUMEN WATER CAPACITY 10.2 al CAPACITE EN EAU MIN MIN 6.5, FILLING DENSITY FULLFAKTOR 81% - • FACTEUR DE REMPL ISSAGE MAX PRÜFDRUCK TEST PRESSURE 250 PRESSION D'ESSAI BAR BURST PRESSURE OF CYLINDER 64.510.3 BERSTDRUCK DES ZYL INDERS >500 PRESSION D'ECLATEMENTE DU CYL INDER BAR KAPPEN ANSTECHKRAFT CAP PIERCING FORCE FORCE DE PERCUTION $300 N CO, (E290) - iSi SPEC 0192 - 99.95% PURITY MARK ING PROCESS: INK JET MARK ING: INSCRIPTION: INSCR S(X AUSTRIA MY MIN.GR.WT XX.XG PRINTING REPEATED THREE TIMES AROUND THE CYL INDER PACKING: LOOSE, IN CARTONS OF 430 PCS CARTON MARKING: CARBON DIOXIDE: 2.2; UN1013 WT OF CARTON: 12.5 KG 018:002 G COPYRIGHT 2 ISi 198-07-26 i5: dabt TITLE: 8G CO, PLAIN NECK GYLINDER 1 RS A-Izta Tim. (85-05-25) Küractmergosso 1 8G OO, ZYL INDER CHNE HALSGEWINDE title RS rece producta are tha nuojam, uí petent. Iss.No. Bate chonge Name alion in AUSTRIÀ, fURORE unt principel BOUTEJLLE DE &G CO. SAMS FILETAGE Data au ai thu morió. Thin drawing and mll Nome în epa dolion or duncriplive natler cet out Mot: SPECIAL DEEP DRAW ING STEEL. W-NR.7.0338 DIN 1624 droom 98-04-08 RS n3l ast & dlunlerad Inanad canioe op uud confidengiel ond copyright nd OrgNo: YH1 J 2 Surface Scaia for parurocluring lendering dr olnue purposes - **truncated:** true - **body characters:** 69611