At Gleisan, your safety and the safety of your clients are our top priorities. Our professional aesthetic devices are designed for advanced cosmetic procedures and must be used with the utmost care and professionalism. This page provides essential safety information and guidelines to ensure the effective and safe operation of your Gleisan equipment. Please read this entire statement carefully before using any of our products.
Professional Use Only
Gleisan professional aesthetic devices are intended solely for use by qualified, trained, and licensed professionals. This includes, but is not limited to, physicians, registered nurses, certified aestheticians, and other healthcare practitioners who have received specific training and certification in the operation of these devices and the procedures they perform.
Under no circumstances should these devices be used by untrained individuals or for self-treatment. Improper use can lead to serious injury, adverse reactions, and device malfunction.
General Safety Principles
To ensure safe operation and optimal results, adhere to the following general principles:
- Read the Operator Manual: Always consult and thoroughly understand the comprehensive operator manual provided with each Gleisan device. This manual contains detailed instructions, specific warnings, contraindications, and maintenance protocols for your particular model.
- Qualified Personnel: Ensure that all operators are fully trained, certified, and competent in the specific procedures being performed with the device.
- Patient Assessment: Always conduct a thorough patient assessment, including medical history, skin type analysis, and identification of any contraindications, before commencing treatment.
- Informed Consent: Obtain informed consent from every client, ensuring they fully understand the procedure, potential risks, benefits, and alternative treatments.
- Sterilization and Hygiene: Maintain strict sterilization and hygiene protocols. Clean, disinfect, and sterilize equipment according to the instructions in the operator manual and local health regulations to prevent infections.
- Regular Maintenance: Perform routine maintenance and calibration as specified in the operator manual to ensure device accuracy, safety, and longevity.
- Adverse Event Reporting: Report any adverse events or unexpected reactions immediately to Gleisan and, if required, to your local regulatory authorities.
Product-Specific Safety Considerations
Our product range includes various technologies, each with specific safety requirements.
Laser & Light-Based Devices (e.g., Hair Removal, Pigment Removal, Tattoo Removal)
- Eye Protection: Always ensure that both the operator and the client wear appropriate, certified laser safety eyewear during operation. Direct or reflected laser light can cause permanent eye damage.
- Skin Type & Setting: Carefully assess the client’s skin type (e.g., using the Fitzpatrick scale) and adjust treatment parameters (fluence, pulse duration, spot size) accordingly to prevent burns, hypopigmentation, or hyperpigmentation.
- Test Patches: Consider performing a test patch on a discreet area of the skin to assess reaction before full treatment.
- Photosensitivity: Advise clients to avoid sun exposure before and after treatment and use broad-spectrum sunscreen. Inquire about photosensitizing medications.
- Contraindications: Avoid use on areas with active infections, open wounds, suspicious lesions, or in clients with a history of keloid scarring, recent sun exposure, or certain medical conditions (e.g., pregnancy, epilepsy, pacemakers).
High-Intensity Focused Ultrasound (HIFU) & Radiofrequency (RF) Devices
- Thermal Injury: These devices generate heat. Monitor the client’s comfort level closely and adhere strictly to treatment protocols to avoid burns or tissue damage.
- Anatomical Awareness: Have a thorough understanding of underlying anatomy to avoid treating over nerves, major blood vessels, or bony prominences.
- Metallic Implants: Do not use on areas with metallic implants, pacemakers, or other electronic devices.
- Contraindications: Avoid use on areas with active infections, open wounds, recent cosmetic injections (wait recommended period), or in clients with certain autoimmune conditions, pregnancy, or severe systemic diseases.
Electromagnetic Muscle Stimulation (e.g., Emsculpt-type Devices)
- Metallic/Electronic Implants: Do not use on clients with metallic or electronic implants (e.g., pacemakers, defibrillators, IUDs with metal, cochlear implants) in the treatment area or within the body.
- Pregnancy/Breastfeeding: Contraindicated in pregnant or breastfeeding individuals.
- Specific Medical Conditions: Avoid use in clients with cardiac conditions, epilepsy, bleeding disorders, malignant tumors, or recent surgeries in the treatment area.
- Proper Applicator Placement: Ensure correct placement of applicators as per the manual to optimize results and avoid discomfort or injury.
Microneedling & Derma Pen Devices
- Sterile Needles: Always use sterile, single-use needle cartridges for each client to prevent cross-contamination and infection.
- Skin Preparation: Thoroughly cleanse and disinfect the skin prior to treatment.
- Post-Care: Provide clear post-treatment care instructions to clients, including guidance on sun protection and avoiding irritating products.
- Contraindications: Avoid use on areas with active acne, cold sores, eczema, rosacea, open wounds, or in clients with certain blood disorders, impaired healing, or keloid tendencies.
Product Liability & Disclaimers
- No Guarantee of Results: While our devices are designed for efficacy, individual results may vary. Gleisan does not guarantee specific outcomes, as results depend on various factors including individual physiology, adherence to treatment protocols, and lifestyle.
- Professional Responsibility: The professional operating the device is solely responsible for proper patient selection, treatment execution, and post-care. Gleisan is not liable for injuries or damages resulting from improper device use, inadequate training of the operator, or failure to adhere to the provided instructions and safety guidelines.
- Limitations of Liability: To the fullest extent permitted by applicable law, Gleisan shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising from or related to the use or inability to use our products.
- Regulatory Compliance: Our products are manufactured to high standards and meet relevant international safety certifications. In Taiwan, our electrical and electronic products comply with the Bureau of Standards, Metrology, and Inspection requirements. Users are responsible for adhering to all local and national regulations concerning the operation and medical use of these devices, including the Medical Devices Act and Consumer Protection Act, which mandate clear warnings and instructions for products that may pose a risk.
Emergency Procedures
In the event of an adverse reaction or unexpected event during treatment:
- Stop Treatment Immediately: Cease device operation and remove applicators.
- Assess the Client: Evaluate the client’s condition and provide immediate care as necessary.
- Refer to Emergency Protocols: Follow your clinic’s established emergency protocols.
- Seek Medical Attention: If the reaction is severe or persistent, seek immediate medical attention for the client.
- Document and Report: Document the event thoroughly and report it to Gleisan.
Your Commitment to Safety
By purchasing and operating Gleisan professional aesthetic devices, you acknowledge and agree to adhere to all safety guidelines, warnings, and instructions provided by Gleisan and within the accompanying operator manuals. Your commitment to safety ensures optimal outcomes for your clients and the continued high performance of your Gleisan equipment.
For any questions regarding product safety or specific device operation, please contact Gleisan customer support.
