What to expect?
The device offers a noninvasive method to help restore the muscle and tissue of your pelvic floor. To help you ease into using the device, we recommend gradually increasing the treatment times over the course of 6-10 weeks. The device provides maximum therapeutic benefits through 6 high-powered LEDs to restore tissue and stimulate collagen. While safe for the eyes, we recommend that you do not stare
directly into the red lights. The device emits a gentle heat, which is very pleasant to many women. Each of us is unique and experiences things differently. If it feels too warm, make sure the device light window is fully inserted into the vagina. Our external vulva tissue is more sensitive to heat than our internal vaginal tissue. If it still feels too warm once fully inserted, ease into usage and start with a lower treatment time until you are comfortable with the gentle heat.
How long should I use the device for?
As with anything new, we recommend taking your time and gradually introducing the device by starting off slowly (6 minutes) and ramping up treatment times until your body is ready. This allows you to become familiar and comfortable with the device and its modes and settings.
Of course, as with any exercise regime, it takes time to notice results. In a consumer study, women used their devices every other day for 10 minutes per day. Over the course of 60 days, women noticed an improvement in intimate wellness, enhanced comfort and pleasure with intercourse, and increased confidence. They then used the device on an ongoing basis, once or twice per week for maintenance. As we all know, you must continue to work out in order to maintain your great results.
What clinical trials have been conducted?
The Issviva x Joylux Vaginal Rejuvenation Device is the first home-use CE-marked medical device.
Following a study carried out by the manufacturers Joylux, after 8 weeks use:
• 89% of users report a decrease in pain
• 91% of users report a decrease in dryness
• 84% of users report increase in comfort
Study: Joylux vFit PLUS Market Perception Study 2018.
Clinical studies reveal that of the women using the device 3 times a week for 6 weeks:
• 77% saw an improvement in sexual function
• 90% saw increased sensitivity
• 92% saw a dramatic improvement in symptoms like urinary distress and incontinence
• 55% no longer had any stress incontinence
Study: de la Torre, S., Miller, L.E. Multimodal vaginal toning for bladder symptoms and quality of life in stress urinary incontinence. Int Urogynecol J 28, 1201–1207 (2017). https://doi.org/10.1007/s00192-016-3248-5
A published study also shows the Issviva x Joylux Vaginal Rejuvenation Device causes an increase of glycogen and thickening of epithelium, tissue covering the internal surfaces of the body. This helps maintain the pH of the vaginal tissue, which prevents Urinary Tract Infections, more common in menopausal women. Women reported they were naturally more lubricated, due to an increase of blood flow to the tissue.
Study: Lanzafame RJ, de la Torre S, Leibaschoff GH. The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Photobiomodul Photomed Laser Surg. 2019 Jul;37(7):395-407. doi: 10.1089/photob.2019.4618. Epub 2019 Jun 17. PMID: 31210575; PMCID: PMC6648197.
https://pubmed.ncbi.nlm.nih.gov/31210575/
Can I use the device during my period?
Yes, the device is safe to use during menstruation. We leave the decision to use during one’s menstrual cycle to the discretion of each individual user. Continue to use if you are comfortable doing so or take the week off if you prefer.
Can I have sex after using the device?
Yes, it’s okay to have sexual intercourse after using the device.
Do you offer a warranty?
Activate your one-year warranty against manufacturer defect-related problems resulting from normal use of the product by registering your device today at joylux.com/warranty. Not covered under the one-year warranty: damage caused by misuse, abuse, neglect, alterations, or unauthorised repair; normal wear and tear, including chips, scratches, abrasions, discoloration, or fading.
Precautions
• The device is not intended for use by anyone under the age of 18, and close adult supervision is necessary if children under the age of 18 are near the device.
• The device is not waterproof and should not be submerged. It can be cleaned with a damp cloth.
• Only connect the device with the USB cable provided and to USB power adapters certified in compliance with IEC 60950- 1 or IEC 60601- 1 based national standards.
• No modification of the equipment is permitted.
• Do not disassemble the equipment.
• Do not attempt to charge device while it’s in use.
• Mobile RF communications equipment can affect medical electrical equipment.
• Do not use if you have autonomic neuropathy, sensory neuropathy, or pseudomotor dysfunction.
• The device is designed for individual use only. Please do not share with others.
• After each use, the device should be thoroughly cleaned.
• The device should not be used in the presence of an active sexually transmitted infection, as an active infection may have symptoms that are aggravated by use of the device.
• Do not use the device if you are using cancer-fighting drugs, medications, or topical creams that increase photosensitivity. These may cause an adverse reaction.
• For optimal performance, we recommend using the device with a water-based lubricating gel.
• The device is intended for vaginal insertion only.
• Do not use silicone-based lubricants with the device.
• Do not stare directly into the device lights.
• Do not use if you are pregnant or believe you may be pregnant.
• If you are experiencing abdominal pain, or have other medical issues or health concerns, please consult your physician before using the device.
• If you experience numbness, skin irritation, dizziness, or feel pain, stop using the device immediately and consult your physician.
• Exercise caution when using near body piercings.
• If you are experiencing prolonged redness or sensitivity in the treatment area, discontinue use and consult your physician.
• If any part of the device is cracked, broken, or damaged, or if there are signs of moisture or condensation on the inside of the device, discontinue use immediately.
• Do not use the device if the lights have been damaged in any way.
• If the device begins to overheat, turn off immediately.
• Do not use the device if you think the device has been immersed in water.
• Do not use or store the device near water, or where it can be dropped or pulled into water.
• Keep the USB charging cord away from children, as it poses a strangulation risk.
• Keep the charging cord away from heated surfaces.
• Do not operate the device or charging cord if either component has been damaged, dropped, or immersed in water, or if the cord is frayed or damaged.
• Do not disassemble. If the device is malfunctioning, contact hellouk@issviva.com.
