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DERMAPEN HOME - Device Description

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8Dermapen HOME
TM
User Manual
4 - DEVICE DESCRIPTION
The Dermapen HOME
TM
system consists of the following components:
Dermapen HOME
TM
Device
Dermapen HOME
TM
Needle Cartridge
Dermapen HOME
TM
Battery Charger
Dermapen HOME
TM
Power Charging USB cable
Dermapen HOME
TM
Batteries x2
The Handpiece contains a drive train, a digital display to relay
information to the operator, an ON/OFF button to power the device
on and o and two separate toggle buttons to adjust frequency
(speed) and needle level (depth).
The Handpiece receives its power via removable lithium-ion battery
(3.7 VDC).
The drive train encompasses a DC motor, eccentric cam and
rotational to linear drive converter to oscillate the Needle Cartridge.
The digital display shows battery status, cartridge status, sync/
update notifications and Bluetooth connectivity. The display also
contains a digital dial to convey frequency or motor speed and a
3-figure display showing current needle level.
The frequency of oscillation (speed) can be set from 80-120Hz
(+/-10 Hz) and the needle level from 0.2mm to 0.5mm (0.1mm to
0.3mm ANZ).
The Needle Cartridge is a sterile, single-use consumable designed to
create micro incisions in the epidermis and dermis. Each cartridge
contains 16, 33-gauge surgical grade stainless steel needles,
arranged in a circular pattern. Each Needle Cartridge employs a
bayonet feature to securely connect it to the Handpiece during
operation. Internal and external seals assist in the prevention of cross
contamination, while a safety cap helps avoid needle stick injury.
Each Needle Cartridge contains an RFID tag encoded with a unique
ID and a needle level correction factor. This information is read
from the cartridge when it is first inserted into the Handpiece and
prevents reuse of the cartridge once the cartridge is removed from
the Handpiece.
The battery charger is capable of charging 1x 14500 Lithium cell.
The system batteries can only be charged when removed from the
Handpiece and inserted into the battery charger.
The equipment is not used to make measurements of any sort, or to
draw any conclusions regarding the indication to treat.
The Dermapen HOME
TM
is intended to be used by lay users.

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