Elcam Medical New Generation Flexi-Q Auto-Injectors

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General• Identified Hazard: Compromised needleproperties (e.g., needle dulling) due to a singleadditional penetration into the VA septum• Mitigation:○○Performing a study with the following objectives:• Examine whether the needle properties arecompromised• Selection of septum material (TPE or a onecommonly used for NS)Performing the study with the most experienced,external objective laboratory for testing needle quality(Melab GmbH, Germany)38
Method• Glass syringe, 3-bevel 27G staked-in needle, RNS• Penetration force test – DIN 13097 (09/2002)○○commonly used world-wide to examine needles quality0.4 mm thick Polyurethane (PU) foilPenetration load-measuring equipment(a) glass syringe with staked-in needle , (b) testingfoil, (c) foil support, (d) transferring unit, (e) loaddetector, (f) amplifier, (g) recording unitTypical graphF 0 – tip resistance (piercing)F 1 – cutting resistanceF 2 – dilatation resistanceF R – friction of the shaft39
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 and 28: • Discard the device according to
Page 29 and 30: Device Validation• Simulated Clin
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: Background (cont.)• In many cases
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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