Elcam Medical New Generation Flexi-Q Auto-Injectors

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Flexi-Q DV Auto-injectorCase Studies:1. Simulated Clinical Use Study2. Needle Tip StudyFlexi –Q DV
Device Validation• Simulated Clinical Use Study• Performed based on the FDA CDRH Guidance:“Medical Devices With Sharps Injury PreventionFeatures”29
Page 1 and 2: Elcam MedicalNew GenerationFlexi-Q
Page 3 and 4: Elcam’s Manufacturing Facilities
Page 5 and 6: 5Elcam’s Major Customers
Page 7 and 8: Novel, Commercially AvailableFlexi-
Page 9 and 10: Flexi-Q DV Design Characteristics -
Page 11 and 12: Vial Adaptor Options• Standard Vi
Page 13 and 14: Yellow RodRed INJECTButtonGrip Area
Page 15 and 16: 1. Remove the Safety Cover of theAu
Page 17 and 18: 41. Gently Push the Yellow Rodall t
Page 19 and 20: 61. Hold the Auto-injector vertical
Page 21 and 22: 81. Tap near Dosage Window to movel
Page 23 and 24: 101. Remove the Gray Connector bypr
Page 25 and 26: 121. Hold the Auto-injector at the
Page 27: • Discard the device according to
Page 31 and 32: Study Results1. All users successfu
Page 33 and 34: 33Flexi-Q P-DVR use by RA Patient:v
Page 35 and 36: Background• Flexi-Q DV is assembl
Page 37 and 38: Background (cont.)• In many cases
Page 39 and 40: Method• Glass syringe, 3-bevel 27
Page 41 and 42: Results & DiscussionTPE SeptumF 1 -
Page 43 and 44: ConclusionsUsing the TPE Septum mat
Page 45 and 46: Testimonials - from recent work wit
Page 47: Summary: Elcam Medical• Elcam has

Elcam Medical New Generation Flexi-Q Auto-Injectors

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