Usability Study The LeEject Dental Safety Needle & Syringe System and instructions for use are surveyed by ten operators that have read the LeEject instructions for use and used the LeEject Dental Safety Needle & Syringe System. Questionnaire for Using the LeEject Dental Safety Needle & Syringe System 1. User Information Date: Name: Age: Sex: Male Female Educational background: High School College (Major: ) Graduate School (Major: ) Dental Hygiene Program Dental School Responsibility (Position): Dental Assistant Dental Hygiene Student Dental Hygienist Dental Student Dentist Experience as a dental professional? Year(s) or less than 1 year Have you ever operated a dental needle & syringe? Yes No If the answer to the above question is yes, what is the name of the dental needle & syringes you use currently? Are you satisfied with these products? Brand of Needle: Brand of Syringe: Comments: Do you practice the one handed scoop technique or use any safety devices to recap the needles? One handed scoop technique Safety device, Name of the device to recap needles: Have you experienced any needle stick injuries within the last 24 months? Yes No Usability Study 1/7
2. LeEject Device Questionnaire 1. The weight of the LeEject syringe was similar to that of a conventional dental syringe, and fits my hand comfortably. 2. Was it easy to load the anesthetic cartridges into the LeEject syringe? Very Easy Easy Average Hard Very Hard 3. Was it easy to insert the LeEject needle into the LeEject syringe? Very Easy Easy Average Hard Very Hard 4. Passive aspiration works only after a brief injection of a few droplets of local anesthetic. The aspiration of blood into the anesthetic cartridge was clearly visible. 1 2 3 4 Clearly Visible Visible Indistinguishable Not Visible 5. I am satisfied with the Passive aspiration feature. Very Satisfied Satisfied Average Dissatisfied Very Dissatisfied 6. The device is capable of manual-aspiration, which allows aspiration before and during injections. The engaging of the harpoon into a cartridge is comparable to other conventional syringes. 7. I had a clear view of the injection site and needle tip. 8. I was able to give injections in all mouth sizes and all areas of the mouth. Usability Study 2/7
9. Was it easy to unload the cartridge for disposal? Very Easy Easy Average Hard Very Hard 10. It was easy to unload the cartridge and reload the cartridge for multiple injections. 11. It was easy to unload the LeEject needle for disposal into a sharps container. 12. How satisfied are you with your performance of the LeEject System? Very Satisfied Satisfied Average Unsatisfied Very Unsatisfied 13. Do you have suggestions for any improvements for the LeEject System? If so, what are they? 14. How many attempts were required to be comfortable with the LeEject System? 1-2 3-4 5-6 7-8 9-or more 15. Did you have any technical problems with the LeEject syringe or LeEject needle during injections? Yes No If the answer to the above question is Yes, please describe the problem. Usability Study 3/7
3. LeEject Instructions Questionnaire 1. How helpful are the instructions in using the LeEject System? Very Helpful Helpful Average Unhelpful Very Unhelpful 2. The description of insertion of cartridge is easy to understand and follow. 3. The description of insertion of the LeEject needle is easy to understand and follow. 4. The description of Passive aspiration feature is easy to understand and follow. 5. The description of manual aspiration is easy to understand and follow. 6. The description of disposal of the cartridge is easy to understand and follow. 7. The description of unloading and reloading of the cartridge is easy to understand and follow. 8. The description of disposal of LeEject needle is easy to understand and follow. Usability Study 4/7
9. The description of retrieval of the dropped LeEject needle is easy to understand and follow. 10. Are the instructions presented in a proper step-by-step manner? 11. It is easy to learn the operating procedure of the LeEject System. 12. All in all, how satisfied are you with the Instructions for Use? Excellent Good Average Bad Very Bad Comments Usability Study 5/7
User Information Summary Table Item Classification Quantity Percentage Gender Male Female 18-20 years 21-30 years Age 31-40 years 41-50 years 51-60 years 61-70 years High School Educational Level College Graduate School Dental Hygiene Program Dental School Dentist Responsibility (Position) Dental Hygienist Dental Assistant Dental Student Hygiene Student less than 1 year Experience of the Dental Professionals 1-3 years 4-7 years over 8 years Usability Study 6/7
LeEject Consent Form Name of Patient (Printed) I consent to have dental anesthetic injections done by the LeEject Dental Safety Needle & Syringe system. I was informed that the LeEject Dental Safety Needle & Syringe system: 1) Is not US FDA approved as of yet. 2) Does not affect the strength or dose of the local anesthetics. 3) The LeEject dental needle sizes and lengths are similar to conventional needle sizes and lengths. 4) The LeEject Dental Safety Needle & Syringe system differs from conventional systems, only in the attachment of the needle to the syringe. 5) The LeEject Dental Safety Needle & Syringe system offers Passive aspiration similar to other passive aspirating and self-aspirating syringes and needles offered in the US market. Signing below indicates that I have read the above statements and understand their contents. Please sign and date below. Signature of Patient Date Name of treating Dental Professional (Printed) Signature of treating Dental Professional Date Name of Witness (Printed) Signature of Witness Date Usability Study 7/7