Elcam Medical New Generation Flexi-Q Auto-Injectors
Elcam Medical New Generation Flexi-Q Auto-Injectors Elcam Medical New Generation Flexi-Q Auto-Injectors
Method (cont.)• Compare needle quality before and after penetrationinto the vial adaptor septum:○○Group A*: simulation of real use (N=32)tested once following removal of the RNS, and thenafter a single penetration into the Vial Adaptor Septum (TPE)Group B: excessive number of septum penetrations (N=3)tested after 12 septum’s penetrations, and after re-coatingwith silicone oil (explore wiped away silicone effect)• Needle tip investigation for damages by usingx30 magnifying microscope40* Note: another group (N=32) was used for the 2 nd option ofSeptum material (as material not selected – these results are notshown).
Results & DiscussionTPE SeptumF 1 – cutting resistancerepresents tip qualityF R – friction of the shaftassociated with siliconization layerNeedle conditionNew. Only RNS piercingAfter single septum penetrationAfter 12 septum penetrationsF 1– max load [N]Avg. ± SD0.84 ± 0.030.94 ± 0.040.96 ± 0.04F R[N]Avg. ± SD0.16 ± 0.020.18 ± 0.020.33 ± 0.01ControlgroupDevicenormaluseAfter re-coating0.88 ± 0.030.11 ± 0.0141• Slight increase in the max force (F 1 ) after septumpenetration (single or multiple)• Decreased after re-coating with silicone-oil• No change in Friction Force (F R ) after singleseptum penetration• Friction Force is doubled after 12 penetrations anddecreased back after re-coating
- 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 and 38: Background (cont.)• In many cases
- Page 39: Method• Glass syringe, 3-bevel 27
- 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
Results & DiscussionTPE SeptumF 1 – cutting resistancerepresents tip qualityF R – friction of the shaftassociated with siliconization layerNeedle condition<strong>New</strong>. Only RNS piercingAfter single septum penetrationAfter 12 septum penetrationsF 1– max load [N]Avg. ± SD0.84 ± 0.030.94 ± 0.040.96 ± 0.04F R[N]Avg. ± SD0.16 ± 0.020.18 ± 0.020.33 ± 0.01ControlgroupDevicenormaluseAfter re-coating0.88 ± 0.030.11 ± 0.0141• Slight increase in the max force (F 1 ) after septumpenetration (single or multiple)• Decreased after re-coating with silicone-oil• No change in Friction Force (F R ) after singleseptum penetration• Friction Force is doubled after 12 penetrations anddecreased back after re-coating
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