User Manual
WT-UM-08 (v4.4)
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1 INTRODUCTION
1.1 Intended Use
The WON COSJET ATR S laser system is intended for the non-invasive Incision, Excision,
Ablation and Vaporization of Soft Tissue for General Surgical Procedures for Coagulation and
Hemostasis.
WARNING: Basically, the WON COSJET ATR S laser system must be operated by a physician
with a qualification of dermatology, nurse or any specialist, and who has been trained on the use of
the product.
1.1.1 Description
The laser system is an effective treatment for dermal pigment lesion which can generate cancer
factors.
1.1.2 Equipment application specification
1.1.2.1 Medical purpose
The WON COSJET ATR S Nd:YAG laser system has extended laser penetration into both
epidermis and dermis without any damage to skin cells
1.1.2.2 Patient population
1) Age: More than 18 years old
2) Weight: Not relevant
3) Health: Not relevant
4) Nationality: Multiple
5) Patient State: Patient is not operator: not relevant, unless patient is agitated.
1.1.2.3 Part of the body or type of tissue applied to or interacted with
1) Treatment site:
- Skin surface
2) Condition: intact skin, treated skin
1.1.2.4 Intended operator
1) Education:
- Dermatologist or physician trained by WON TECH
2) Knowledge:
- Understands laser treatment procedures as a physician or dermatologist.
3) Language understanding:
- English
4) Experience:
- Dermatologist or physician trained by manufacturer.
5) Permissible impairments:
- Impaired by 40% resulting in 60% of normal hearing at 500Hz to 2kHz
- Mild reading vision impairment or vision corrected to log MAR 0.2(6/10 or 20/32)
1.1.2.5 Application
1) Environment
- General:
Intended for professional use
Use at clean room of hospital for treatment
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