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TF co2 Laser

 

Product description and summary.

The Areton 3 in 1 CO3 Fractional laser uses the CO2 laser technology This device weighs approximately 40 Kgs according to the types of components and unit.

We have two types of CO2 Laser devices. These are made on demand.

1  Water Based

The water based is the most economical option and it has the disadvantage of requiring water inside the sytem in order for the Device to operate. The Water should be replced every month to avoid accuulation of unwanted particles which can clog the system in the long if the liquid is not changed. It is arequirement to add into this syestm a anti freeze iquid. Any car aniy freeze liquid can be added into the water. This is a neccessary requiremnt as the freezing of the water over winter can cause the laser bulb to crack and render the device inoperative. In order to resolve this type of problem the cracked COs glass glass tube has to be replaced for a new one. This can be costly especially due to the use of specialised labour on site.

 

2 Solid State

The solid state laser on the other hand does not require maintennace Thesrefore is is the preferred option for our design. However the solid state CO Laser generator is several times more expensive than the Glass Tube CO2 laser which requires the use of water. Therefore this different component is proposed to the clients at quotation stage and the solid state component will be placed inside the unit in case the client prefers it.

 

 

Intended use and operation.

The unit has three modalities of  operation:

1 Fractional Laser. This allows the user to inflict small ablations on the skin which will then cause collagen regeneration during the healing process.

The user can select he shape of the ablation spats configuration. Rectangle, triangle, Circle , ellipse, Line etc. This alows the user to cover relatively large areas relatively quickly and then reduce the size and gange the shape in order to cover thise areas which requires more attention like the corner of the eyes lower eyeids ets. Generally all the skin on the body can be treatmed, however the upper eyelids should be only treated wearing intraocular protection.

The user is able to set the following parameters:

  • Relative power intensity of the ablation spots in Watts (this is only an indication of the lasers’ power intensity), it should not be considered as an absolute value
  • Duration of the ablation spots in milli Seconds
  • The distance between the spots.
  • Number for hits of the spots. For example the user can select to hit the same spot once, twice, up to 20 times. This is selectable by the user.

These parateters, in particular the first 3 determine the the overall intensity of the treatment as seen later in the clinical data.

 

Mole removal option.

The Second madality of operation is the mole and skin imperfection removal function.

This function is designed to produce a single consinous ablative laser source whichis capable of ablating skin tissue. This is only used for mole removal, Hypertrophic scar removal and attenuation as well as skin imperfection correction. The head piece for tiis a  relatively small.

 

Vaginal Rejuvenation option.

Laser vaginal rejuvenation is a comon application in aesthetics. This device is has two sub functions:

External Vaginal Rejuvenation, where the device is used in the same fractionated way as we have seen in fractional skin rejuvenation but in the outer vaginal area.

Internal vaginal rejuvenation where the LAser is distributed in 360 circles in the internal wall of the female vagina.

 

Envisaged Manufacturing methods.

The entire manufacturing is going to be subcontracted. The reason for subcontracting the manufacturing is the high cost of writing the software and making the hardware. There are already several OEM manufacturers who make the necesary control PCB and have the software and sell them to assemblers. We intend to use this modality of assemly subcontracted to a thrid party of our choice. The cost of designing brand new PCBs and software for tese units are prohibitive ranging in the region of

There are two main

 

Accessories descriptions.

Fractional head.

CO2 laser pen for skin imprefections removal and moles removal.  removal

Accessories for Vaginal Rejuvenation.

Activation Pedal.

 

Device classification.

2 b. This is because the device is intended to emit energy into the body.

 

Applicable directives and standards.

Design Solution to comply with applicable directives and standards.

Evidence of compliance with the standards and directives.

Design riskassessment.

Specification of materials and circuit diagram for components subassemblies and the complete product including packaging where appropriate.

The specifications of the checks, tests and trials that are intended to be carried out as part of routine production.

The performances and compatibilities intended by the manufacturer.

Labelling, including any instructions for use.

Identification of ‘shelf-life’ reflected by any ‘use by’ date, or other ‘lifetime’ of the device(s).

Results of Bench Testing.

Clinical Data.

Co2 lasers have been used for several years in the field of skin rejuvenation, benign skin lesion removal and vaginal rejuvenation. We have made this device in order to provide a great deal of value within  the market place. Up until now these types of Devices were very expensive.

This is due to the complexity of these devices. Today standirdasation of desigs and  and the wide availability of the components make these devices more accessible in the market place.

The intensity of the treatment in the fractionalted the laser is proportional to the porwer of each individual spot,

the duration of the spots and the distance between the spots. The intensuty of the skin resurfacing treatmen is not only due to the power setting of the device per se.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2918344/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4134658/

Documentation and reporting of Design Changes
Risk assessments

In the operation of the device the user has to start using the device at lhe lowest power level possible for each application first. Tgen though experiance the

 

Author Andreas Russo