Transcript Transderm® Ionto

®
Transderm
FDA 510K Approved
Ionto
Transderm® Ionto
Intended Use:
 The Transderm® Ionto
is a powered drug
delivery system that is
indicated for the local
administration of ionic
drug solutions into
the body for medical
purposes and can be
used as an alternative
to injections. -
Transderm® Ionto
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Stand alone device
(US Market only)
Easy to use
Adhesive active
electrode cap
Ionto & Ionto Lips
Versions
Powered by Ultrapeel®
microdermabrader
Transderm® Ionto
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Transderm® Ionto
powered by Ultrapeel®
Single system offers
Microdermabrasion and
Dermoelectroporation
PLD to supply the Drug
onto the electrode cap
Transderm® Ionto
The Transderm® Ionto is not:
An ultrasound device
An aesthetic-purpose unit
A cosmetic device (Home
based treatment)
A multi-device unit
A massager
A micro-current device
Transderm® Ionto
Why should I use Ultrapeel®
Transderm® Ionto System ?
Selected advantages Vs Traditional
Ionthophoresis & Electroporation
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Capability to transdermally deliver either micro
and Macromolecules
 Faster pace of delivery (for the same amount of
drug).
 No electrolysis.
 No ionic drug solution degradation.
 No variation of ionic drug solutions pH.
 Ionic drug solution delivery rate reproducibility.
 Both the positive and negative ions of the drug are
transdermally delivered.
 No discomfort to the patient as needles give.
 Non Invasive.
What Ionic drug solutions can be used with the
Transderm®?
Transderm Ionto System can be used by doctors with
any FDA approved ionic drug solution and in the US,
the product officially cleared by FDA for Ionthophoretic
use, is a brand of Lidocaine hydrochloride 2% and
Epinephrine 1:100,000 topical solution.
At the present time, the only brand name officially FDA
cleared is Iontocaine ® (lidocaine hydrochloride 2%
and epinephrine 1:100,000 type) from Iomed inc for
Ionthophoretic use
Any other use (different ionic drug solutions) is under
doctor’s indication considering that the device is, from
an FDA standpoint, recognized as an alternative to
Injections.
What the Transderm® is used for ?
US doctors using Transderm Ionto
System are successfully dealing with various
applications such as collagen and Hyaluronic
acid transdermal delivery treatments, pre-laser
treatments (anaesthetic) for both hair removal
and resurfacing. Some others are using
Ultrapeel Transderm Ionto System with
cancer drugs or steroid delivery. Some others
are using Ultrapeel Transderm Ionto
System for mesotherapy procedures etc…
Transderm Ionto System has been cleared with
the drug dispensing cap electrode. All the other
dispensing caps are equivalent to that
Dispensing electrode cap (See accessories
section for details).
Transderm® Ionto
Ultrapeel® Transderm® Ionto System
Available Configurations
Transderm® Ionto – Available Configurations
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The Ultrapeel ® Transderm® Ionto System
comes up with 3 different configurations:
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Configuration a) Complete system (Two
probes)
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Configuration b) One probe only system
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Configuration c) Item by item system
Configuration a) Complete system (Two probes)
Configuration a) includes the following items:
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Ultrapeel® Crystal T Microdermabrasion system
Ultrapeel® Accessory kit
Transderm® Ionto System
Transderm® Ionto System Ver. Lips
Precision Liquid dispenser PLD
Drug Delivery Electrode cap (box of 10ea)
Electrode Cap Net Version (box of 10ea)
Electrode Cap Lips Version (box of 10ea)
1ea+
1ea +
1ea +
1ea +
1ea +
1 box +
1 box +
1 box
So customer will use both Transderm® Ionto probes (the small and the big one)
and PLD to deliver the ionic drug solution to the Transderm® Ionto probes.
Configuration b) One probe only system
Configuration b) includes the following items:
Ultrapeel® Crystal T Microdermabrasion system
Ultrapeel® Accessory kit
Transderm® Ionto System
Precision Liquid dispenser PLD
Drug Delivery Electrode cap (box of 10ea)
Electrode Cap Net Version (box of 10ea)
Electrode Cap Lips Version (box of 10ea)
1ea+
1ea +
1e
1ea +
1 box +
1 box +
1 box
So customer will use Transderm® Ionto System probe.
Transderm®Ionto probes Lips is optional and must be ordered
separately.
Configuration c) Item by item
system
Configuration c) includes the following items:
Each item is ordered separately.
This configuration applies to those customers
either having an Ultrapeel® Crystal T
Microdermabrasion machine already and want
to upgrade to Ultrapeel® Transderm® Ionto
system in a step by step way.
Transderm® Ionto
Ultrapeel® Transderm® Ionto System
PLD
What PLD is used for?
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The Precision Liquid dispenser (PLD) serves as timely
erogator device for the ionic drug solution to be
transdermally delivered.
PLD Precision Liquid Dispenser
(Part number 33600000)
Commands and Controls
9Vdc Battery Receptacle
Syringe Piston
Sliding positioning system
Speed of Delivery (cc/min) Test Button
Power on Switch
Accessories
The Precision Liquid dispenser comes up with
the following Accessories:
•5cc Disposable Syringe
•9 Vdc Battery
•Screw driver
•Plastic case
•Mounting support
•Operating manual
Transderm® Ionto
System Available Accessories
Accessories
The Ultrapeel ® Transderm® Ionto System
comes up with the following accessories:
Drug Delivery Cap Electrode
(Part number 33610110/U)
Accessories
The Ultrapeel ® Transderm® Ionto System comes up with the following
accessories:
PLD Precision Liquid Dispenser
(Part number 33600000)
Cap Electrode Net Ver.
(Part number 33610710)
Cap Electrode Lips Ver.
(Part number 33610810)
Accessories
The Ultrapeel ® Transderm® Ionto System comes up with the
following accessories:
Disp. Tubing Kit
(Part number 300100010)
Disp. Corundum Set (Part number 30000285)
Disp. Holder (Part number 10010210)
Disp. 45° Tips (Part number 10010142)
Transderm® Ionto
Working with
Ultrapeel® Transderm® Ionto System
Working with Transderm® Ionto
Step1: Ultrapeel® Microdermabrasion
Step2: Apply Transderm Ionto on the area to be treated
Step3: Start PLD
Step4: Start Vibration
Step3: Start Dermoelectroporating the area to be treated
Transderm® Ionto
Distributed by:
Saratoga Aesthetics
Phone: 1-888-785-7546
Fax: 1-803-788-7607
Email:[email protected]