The following list is NOT for the public information NOR medical advise to the patient. Any and all information below must be limited to the user support only.
Frequently asked questions
What is 'Radio Frequency Microneedling'?
Radiofrequency is a type of energy, which measured in frequency per second and fall into the range of 300KHz to 5MHz. The microneedle penetrate the skin layer and deliver radiofrequency energy to the target tissue to induce new collagen and elastin production helping skin become firmer and tighter by the producing heat. Unlike the laser procedure, the radiofrequency microneedling procedure is color-blind so that it is safe, relatively, if you are tan or have a dark color of skin.
What is the difference between AGNES and other RF microneedling devices?
Agnes is an RF microneedling devices like others in the market regarding the energy utilization. However, Agnes is the only RF device to produce stronger energy than other devices to the skin tissue from inducing new collagen production. Further, Agnes is the only RF device utilizing a single pin or three pin needle as an application electrode which partially insulated to protect the epidermis or other tissues from the thermal burn.
Camera - What is the main function of the camera ?
Agnes RF surgical unit has an internal camera unit to inspect the electrode before or during the procedures. The function of the camera unit is;
1. To ensure the insulated coating on the needle or the tip is free from the damage before use.
2. To ensure the needle tip is not bent from contacting bone or any physical damage during the treatment procedure.
Device - Bipolar - What kind of function does bi-polar unit can do for the patient?
The Bi-polar unit in the Agnes RF is also called as High Frequency Stimulator. The bi-polar unit is beneficial to the post care use. Please refer to the operation manual.
Device - Procedure - Is it safe for all skin types by AGNES procedures?
AGNES is a radiofrequency microneedling device for any type of skin color. The Agnes has nine different types of the microneedle, and each type has the different insulation to use the procedure as safe as possible. Further, the output radiofrequency energy from Agnes is NOT like other traditional sine waveforms which can affect thermal damage to the soft tissue by the residual tale heat, but the square waveform of radiofrequency energy by Agnes can save the surrounding tissues from the residual tale heat like fast start and quick stop. Although Agnes RF device is safer in patients of skin color compared to the laser devices, any significant heat can result in increased risk of post-inflammatory hyperpigmentation or any adverse events at any time.
Device - What is the difference between 1Mhz and 5Mhz in Radio Frequency device? and why AGNES uses 1Mhz?
The difference between 1MHz and 5MHz is merely the speed and distance of the thermal effect from the source of radiofrequency energy. If the given power(Watt) and pulse duration (msec) on both 1MHz and 5MHz are the same amounts, then 5MHz will heat the soft tissue or the target tissue faster. While 1MHz will be relatively slower on heating the soft tissue than 5MHz, it covers more extensive areas of the thermal effect than 5MHz and will be more useful to acquire the relatively wider wound geometry.
Needle - What is the material of insulation on the needle?
It is a coating technology called Parylene Coating, which has been widely used in the semiconductor and medical devices industries and is harmless to the human body.
Needle - Is it possible to reuse the needle on the same patient?
All types of Agnes microinsulated needles are single use and not intended for reuse because the insulated coating on the needle tip may be damaged by the various reason during the procedure.
Device - Can Nurse use Agnes in the course of treatment?
US FDA approved Agnes as class type II category, and it means the state-approved licensed medical doctor can use Agnes in the course of treatment. Depending on the state regulation, the staff nurse can operate Agnes to their patient under the state approved licensed medical doctor's direct or general supervision.
Device - Can we sterilize the mono-polar and bi-polar?
Bi-polar handpiece and header can be easily clean by the alcohol swab. However, mono-polar needle holder should be sterilized in the autoclave at the temperature 121 ° C for 30 mins.
Any of the residual blood on the needle holder, especially in the latch hole, will be carbonized, and it will interrupt energy infiltration to the needle.
What kinds of Agnes needles are available? Where to buy?
Support - How can I get a product support?
There are two ways to have customer support. Simply, make a videoclip or picture by your smart phone the problem of the device and provide to the customer support via email or weblink. Your serial number is required to locate the system detail. Our product support team will help and resolve the problem t our earliest convenience.
Warranty - Tell me the device warranty information.
AGNES provides two(2) year manufacturer's limited coverage for main device unit and one(1) year peripherals. Please refer to the user manuals for the detail.
Warranty - Who is responsible for the shipping cost for the repair?
In case of your device need to be delivered to the dealer for any repair, the shipping cost will be paid by either manufacturer or customer depending on the problem.
Screen - No booting sign on the screen after power on.
Carefully follow the below steps.
Screen - From the device initial booting, the loading screen was appeared. However, it does not show home screen thereafter.
Device - No energy from the device
Please proceed the following steps.
Screen - Touch Screen not working
Please follow the steps below.
Camera Screen not working - "Cannot switch to screen mode!"
The touch switch for Agnes camera should be easily activated by touching with your thumb or index finger.
No Sound - from the touch screen
Please check the system volume control at the rear device panel. Refer to #8 below.
System Sound - three beeps when pulsed
This is a system alarm if the ground plate is lost patient skin contact or the needle tip is not properly inserted into the patient skin. Check the ground plate if it is fully covered by the patient skin contact and then, check the ground plate is also connected to the device.
System Failure - Screen not working or blackout, no response, or system freeze
Please follow the following sequence.
Adverse Event - Skin burn
Cause: Incomplete insertion or early withdrawl of Agnes Needle.
Support - Does Agnes has user operation manual?
To obtain manual or update, please email your inquiries at email@example.com or call 844-811-1154.
Filler Injection - How long after filler or Botox injection can we do Agnes treatment?
It should be better for the patient to schedule Agnes Treatment at least a week after filler injection. Even though the filler has resistant to the thermal energy, it is always recommend to have time interval in between any filler injection with Agnes treatment.
Are metal implants a true contraindication or at the discretion of the provider?
Could we cause disfigurement if the areas treated with each needle insertion are to close?
The average interval between needle insertions should be 3.0 - 5.0 mm apart. If the needle insertion is too close to each other, then it may cause severe skin burn and aggravate the swelling after the treatment because of the accumulated heat.
Do you need to turn off the device in between patients, or is it safe to leave it on for an extended amount of time?
Agnes unit can leave its power on in between patient to patients. However, It is recommended to turn off the device for an extended time such as more than a couple of hours for the non-operative status.
Is it ok to use the Bi-polar device right after the Mono-polar treatment?
Is there data on darker skin types not due to RF but due to needle insertion and PIH?
Post-Inflammatory Hyperpigmentation(PIH) on the treated skin could be from the epithermal burn by the incomplete needle insertion or the incorrect pulsation not from the radiofrequency treatment itself.
How relevant is recent sun exposure on Agnes procedure ?
It is irrelevant to Agnes procedures.
Who should I contact for my questions or product support?
Our goal is to provide the best user support, product knowledges and clinical resources that are essential to use Agnes RF for the safe procedure and the best result. Email your questions at firstname.lastname@example.org or call 844-811-1154 to contact our support line. Our office hours are Monday thru Friday, from 8:00 am to 5:00pm PST.