This document describes the Silk'n Tightra (H2401), a Bi-Polar RF (Radio Frequency) device designed for self-treatment to improve the firming and tightening of pelvic floor organs, reduce stress urinary incontinence or vaginal symptoms, and enhance sexual functioning.
Function Description:
The Silk'n Tightra utilizes Bi-Polar RF Energy, which flows between its electrodes, to promote the formation and reconstruction of vaginal collagen and elastin fibers. It offers two treatment modes:
- Internal mode: Aims to tighten the vaginal tissue and muscles of the pelvic floor to increase muscle tone and reduce incontinence.
- External mode: Designed to tighten the external vulva skin tissue for an improved vaginal appearance.
The device is intended for women aged 18 and above. It is not suitable for commercial or therapeutic use.
Important Technical Specifications:
- Model: H2401
- Technology: RT™ (Radio Frequency Technology)
- Bi-Polar RF:
- Frequency: 1MHz ±30%
- Maximum output power: 10W max
- Maximum output current: Not specified, but implied by power.
- Operation & safety:
- Temperature sensor to prevent skin overheating.
- Touch sensor and movement sensor for safe operation.
- Transport & storage condition:
- Temperature: -40 to +70°C
- Relative humidity: 90%rH max
- Atmospheric pressure: 500 - 1060hPa
- Operating conditions:
- Temperature: 5 to 40°C
- Relative humidity: 15 to 90%rH
- Atmospheric pressure: 700 - 1060hPa
- Time from minimum storage temperature between uses to minimum operating temperature with ambient temperature of 20°C: 30 minutes
- Time from maximum storage temperature between uses to maximum operating temperature with ambient temperature of 20°C: 30 minutes
- Protection against electric shock: Class II - charging mode; internally powered medical equipment - treatment mode; Type BF applied part.
- Protection against harmful ingress of water or particulate matter: IP23 (protected against spraying water when tilted up to an angle of 60°).
- Mode of operation: Continuous
- Adapter: KSA-10D-050200HE
- Adapter input; output: 100-240V; 50/60Hz; 0.3A; 5.0V - 2.0A
- Expected service life of the equipment: 5 years
- Battery: Lithium-ion (Li-ion) inside. Initial charge takes approximately 6 hours. Recharge fully after each 20-minute treatment.
Usage Features:
- Device Parts:
- USB port (#1)
- Battery indicator light (#2)
- Control button (#3)
- Treatment mode indicator light (#4)
- Energy level indicator lights (#5)
- Electrodes - internal mode (#6)
- Electrodes - external mode (#7)
- Protective cover (#8)
- USB cable - type C (#9)
- USB adapter (#10)
- Controls:
- Control button (#3):
- Long press: Activates internal mode (energy level 1, treatment mode indicator light off) and shuts down the device (1 vibration).
- Short press x1: Internal mode - energy level 2 (medium).
- Short press x2: Internal mode - energy level 3 (high).
- Short press x3: External mode - energy level 1 (low, treatment mode indicator light on white constant).
- Short press x4: External mode - energy level 2 (medium).
- Short press x5: External mode - energy level 3 (high).
- Treatment mode indicator light (#4):
- Off: Internal mode.
- On: External mode.
- White blinks: System error (alternates with energy level indicator lights #5).
- Energy level indicator lights (#5):
- Green - constant: 1 light - level 1 (low); 2 lights - level 2 (medium); 3 lights - level 3 (high).
- Green - blinks: System error (alternates with treatment mode indicator light #4).
- Battery indicator light (#2):
- Green - blinks: Device charging.
- Green - constant: Device charged.
- Orange - blinks: Low charge in battery.
- Orange - constant: No charge in battery, treatment mode inactive.
- Safety Features:
- Heat stabilizer: Built-in on each of the 16 electrodes (#6, #7). Automatically stops RF energy emission if skin temperature rises too high, resuming when temperature lowers.
- Touch sensor: Ensures RF Energy is emitted only when electrodes (#6, #7) are in good contact with the skin.
- Movement sensor: In external mode, RF Energy is emitted only when the device is moved across the skin.
- Treatment Plan:
- Each internal or external treatment lasts 20 minutes.
- Use the device 2 or 3 times a week for 4 weeks.
- After the initial 4 weeks, gradually reduce use to once a week, then every 2 weeks or less frequently, based on specific needs.
- What to Expect During Treatment:
- A sensation of heat (normal for both internal and external treatments).
- Some redness or slight swelling of the skin (may occur around the vagina after external treatment, typically lasts no more than 24 hours). Aloe vera gel is recommended for these reactions.
- A short vibration every few minutes (normal, indicates device is active).
- Temporary increase in incontinence (when using internal mode, some users may experience increased urination frequency, which should subside in a few days as incontinence effects reduce).
- Possible Side Effects and Recommendations:
- Minor discomfort (stinging sensation): Use a lower energy level and wait until discomfort subsides before the next treatment.
- Excessive heat sensation: Reduce energy level until comfortable.
- Allergic reaction: Stop treatment and consult a physician if the reaction persists for over 24 hours.
- Excessive redness and swelling (external mode): Treat with frequent aloe vera cream applications. Wait until the effect clears before the next treatment. Consult a physician if redness persists for over 5 days.
- Blisters or burns (external mode): Cool the affected area and apply anti-burn cream. Use a lower energy level. Consult a physician if the skin does not return to normal within a week.
- Spotting (internal mode): Consult a physician if the effect continues for more than 24 hours.
- Severe effects: Stop use immediately if effects are severe (full redness, blistering, burns, pain, device too hot). See a physician if effects do not subside within 2-3 days.
- Pre-treatment Steps:
- Ensure battery is charged.
- Empty the bladder.
- Check gel expiry date.
- Remove protective cover (#8).
- Clean electrodes (#6, #7) with a vaginal wipe and dry with a clean paper towel.
- Do not use flammable liquids (alcohol, perfumes, sanitizers, acetone) to clean skin before use.
- Remove all piercings or metal from the treatment area.
- Internal Mode Treatment Procedure:
- Apply a small amount of supplied gel to all electrodes (#6, #7). No internal gel application needed.
- Turn on the device by long pressing control button (#3). Internal mode is active, set to energy level 1.
- Lie down comfortably.
- Insert electrodes (#6, #7) into the vagina as far as comfortable. Support the device by closing legs slightly (if splayed) or placing a cushion under it (if legs are bent). Holding the device is also an option.
- After 5 minutes, if comfortable, short press control button (#3) to move to energy level 2, then again for level 3.
- Keep the device in place for 20 minutes. Lie still, but rotate the device occasionally to ensure energy flow. Device shuts down after 20 minutes.
- During treatment, a vibration occurs approximately once a minute.
- In case of pain/discomfort: reduce energy level (if using 2 or 3) or remove device and wait until comfortable (if using level 1).
- External Mode Treatment Procedure:
- Skin should be shaven, clean, dry, and free of powders, antiperspirants, or deodorants. Ensure skin is not red or inflamed.
- Apply a small amount of supplied gel to the 3 silver-colored electrodes (#6, #7). No internal gel application needed.
- Turn on the device by long pressing control button (#3), then short press it 3 times. External mode is active, set to energy level 1. Treatment mode indicator light (#4) will be on (constant white).
- Lie down comfortably.
- Hold the base of the device and place the 3 silver-colored electrodes (#6, #7) on the labia. The triangular shape helps position correctly.
- After 5 minutes, if comfortable, short press control button (#3) to move to energy level 2, then again for level 3.
- If heat feels too intense, increase the treatment area and/or keep moving the device.
- If device is difficult to move, apply more gel.
- Continue gliding the device across the labia for 20 minutes. Device shuts down after 20 minutes.
- During treatment, a vibration occurs approximately once a minute.
- In case of pain/discomfort: remove device and wait until comfortable.
- After Treatment:
- Avoid very hot water for 2 days.
- Contact physician if there are signs of infection, excessive swelling, redness, pain, or unusual symptoms.
Maintenance Features:
- Cleaning:
- Use a vaginal wipe to remove any gel residue from the device, including the treatment surface.
- Dry the device with a clean paper towel.
- Cleaning fluids with up to 70% alcohol may be used, but never acetone or other abrasive fluids.
- Never immerse the device or any of its parts in water.
- Storage:
- Store the device in its storage case after cleaning.
- The protective cover (#8) can be placed over the electrodes (#6, #7), but it is not essential.
- Disposal:
- Follow country's laws for disposal of electrical items.
- Packaging: Dispose of cardboard and carton as waste paper, and film via recyclable material collection.
- Battery removal: At the end of the product's life, the battery must be removed before disposal. This requires opening the device, which will render it non-functional and void the warranty. The manufacturer is not liable for damages resulting from this procedure.
- Device: Do not dispose with household waste. Dispose of at a designated recycling collection point for electrical devices (WEEE directive). Ensure the device is recycled professionally and prevents release of harmful substances. The device should be in an uncharged state before disposal. Products labeled with Cd=cadmium, Hg=mercury, Pb=lead.
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