Elcam Medical New Generation Flexi-Q Auto-Injectors

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Elcam Medical• Elcam Medical is a leading worldwide OEMsupplier of Fluid Management, Drug Delivery andVital Signs Monitoring systems and devices• Our Quality System is in full accordance with theFDA QSR, European Medical Devices Directiveand is ISO 9001, ISO 13485 certified2
Elcam’s Manufacturing Facilities• 27,000 sq. ft. of class 100,000 clean rooms at Kibbutz BarAm• 10,000 sq. ft. of class 100,000 clean rooms at Dalton• Manufacturing in the US via acquisition of Injectech• Manufacturing in the EU via acquisition of Lucomed• Precision injection molding processes, including 2C (TwoComponents) and LSR (Liquid Silicon Rubber)• Fully automated production floor utilizing custom madeassembly machines3
Page 1: Elcam MedicalNew GenerationFlexi-Q
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 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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