brochure - DALI Medical Devices

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International
P a t e n t
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P e n d i n g
Fully-Disposable
Auto-Injector
for Drugs in Vials
F u l l y - D i s p o s a b l e
Unique Benefits
The Fully-Disposable Auto-Injector for Drugs in Vials provides
both simplified reconstitution and aspiration from conventional
vials and the benefits of automatic injection with safety
needle protection. Reconstitution and aspiration is easily
performed by using a unique vial adaptor and a diluent
prefilled syringe, or a conventional empty syringe
- either of them pre-packaged within the injector.
A unique vial adaptor enables easy drug reconstitution and aspiration
with minimal steps
Optimizes drug extraction from vial and enchances dosing consistency
Facilitates reconstitution of hard-to-dissolve drugs by offering
swirling and time delays
Reduced needle phobia - User never sees or handles the needle
Designed to reconstitute and inject one or more drug vials with
variable volume of diluent
Safe for use - Needle is protected during all the reconstitution steps
and is automatically protected after injection, preventing needlesticks
Offers simplified 510(k) and CE Mark regulatory paths
Complementary Major Advantages and Features of
the Fully-Disposable Auto-Injector
Two steps activation - Minimizing false firing
Simple user interface
Reduced waste of expensive drug due to misuse
The entire dose is delivered - Same dead space as with
manual technique
Quiet operation - Avoiding anxiety and perceived pain
Reduced local reaction - Injection only after full needle
penetration is achieved
Automatic needle insertion into a factory-preset
penetration depth
Automatic injection with a factory determinable injection
profile
Visual inspection of syringe contents through the full
length of the barrel

F u l l y - D i s p o s a b l e
Additional Unique Features
Pre-packaged diluent prefilled syringe (1)
User control of needle penetration depth
Standard needle engagement for injection when a conventional
luer-lock syringe is pre-packaged within the auto-injector.
Drug reconstitution & mixing through multiple-chamber
prefilled syringe. Facilitating reconstitution of hard-to-dissolve
drugs by offering swirling and time delays followed by user
inspection before performing the automatic injection.
The design may be customized for a variety of drug
enclosures and volumes.
Instructions for Use
1
Pull out Needle Cap, click Vial
Adaptor onto the injector and set
desired diluent volume by
pressing the Plunger*.
2
(1)
Insert vial into the Vial Adaptor,
press Plunger to inject the diluent
into the vial, then pump mixed drug
back into the auto-injector.
Note: Should you need to mix more
than one vial, replace the empty vial
with a new one and repeat step 2.
3
4
Remove used autoinjector
from skin and
discard** properly.
Detach Vial Adaptor from the
injector. Press injector against
skin and press Inject Button. Hold
still for 10 seconds. You will hear
a click at the end of injection. You
may also observe the piston
reaching the end of the barrel.
* If you have an empty syringe and need to pump diluent from a vial, inject
the set amount of air into the diluent vial and then pump the desired amount
of diluent from the vial. Take off the diluent vial and continue to step 2.
** When the auto-injector is removed from the injection site, a Needle
Guard automatically covers and locks over the needle for safe disposal
of the used auto-injector.
Note: This product is not available yet for marketing.
Head Office / Manufacturer
Elcam Medical
BarAm 13860
Israel
Tel: 972-4-698-8120/1/2
Fax: 972-4-698-0777
sales@elcam.co.il
www.elcam-medical.com
USA
Elcam Medical, Inc.
2 University Plaza, Suite 620
Hackensack, NJ 07601
Tel: 201 457-1120
Fax: 201 457-1125
info@elcam-medical.com
www.elcam-medical.com
DALI Medical Devices Ltd.
2 Rojanski St.
Rishon LeZion 75706, Israel
Tel: +972-3-951 9675
Fax: +972-3-951 9649
email: info@dalimed.com