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

FAQ

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. The use of Agnes for any aesthetic procedures in the US is considered an off-label procedure. Approved as a general clearance and no indication for any specific procedures under US FDA. K192728




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. Ex) Syneron Profound 0.5MHz, Agnes RF 1.0MHz, Scarlet 2.0MHz, Thermage 6.0MHz




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. The damaged insulation on the needle tip can harm patient skin by the overheated need tip or deliver less energy as much as 40% reduction to the skin tissues. Further, there is an increased possibility of infection from the multiple uses and sever skin burn.




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. We advise you to contact the regulatory agencies and/or the legal counsel for your questions.




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.
= Bipolar




What kinds of Agnes needles are available?  Where to buy?


Agnes microinsulated needles are nine different types, and each type has the unique size and shape for the procedure. Needle tip lengths and its proximal insulations are different from the type to type. For the details, please refer to user reference. To place your order, please contact 844-811-1154 or email at sales@iagnes.com.




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. If you need the immediate support, please call 844-811-1154 extension 905.




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. For the extended warranty information, please contact our sales advisor at 844-811-1154.




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. If the repair issue is caused by the device system problem within the warranty period, then the manufacturer will paid for the shipping and labor cost without charging you. However, if the problem is caused by the user's own misuse, then the user should pay for the shpping and labor cost. Please contact our product support at info@iagnes.com or call (844) 811-1154 for the detail. Agnes Medical provides a 2 years of limited system warranty for repairs and free system upgrade. Please check with your local sales rep for the detail.




Screen  - No booting sign on the screen after power on.


Carefully follow the below steps. 1. Turn off the power switch on the back. 2. Disconnect the footswitch connector. 3. After 10 - 20 seconds, turn on the power switch. 4. Wait for the system rebooting. 5. Check the touch button on the LCD screen if respond. 6. If the LCD screen is ok, then connect the footswitch to the device. 7. Continue the treatment. 8. If the monitor is still not working after the above steps, please disconnect the power cord and reconnect the power cord directly to the other wall power outlet. Not to the extension power outlet. 9. Repeat the above step 1 through 6. 10. If the monitor is not responding, then contact customer support at (844) 811-1154 for further help.




Screen - From the device initial booting, the loading screen was appeared.  However, it does not show home screen thereafter.


Carefully follow the below steps. 1. Turn off the power switch on the back. 2. Disconnect the footswitch connector. 3. After 10 - 20 seconds, turn on the power switch. 4. Wait for the system rebooting. 5. Check the touch button on the LCD screen if respond. 6. If the LCD screen is ok, then connect the footswitch to the device. 7. Continue the treatment. 8. If the monitor is still not working after the above steps, please disconnect the power cord and reconnect the power cord directly to the other wall power outlet. Not to the extension power outlet. 9. Repeat the above step 1 through 6. 10. If the monitor is not responding, then contact customer support at (844) 811-1154 for further help.




Device - No energy from the device


Please proceed the following steps. 1. Check the ground plate if it is placed to the direct skin contact. * Depending on the device version, the device will alarm as three short beeps if the ground plate is not placed or mispaced to patient skin contact. 2. Check the footswitch connection if disconnected. 3. Check cables and connections if properly engaged by its color accordingly. 4. Check the LCD screen if the mode is set as Standby or Ready mode. If still not working, then contact our product support line at (844) 811-1154. = bipolar power mono-polar mono




Screen - Touch Screen not working


Please follow the steps below. 1. Turn off the power button on the device and remove all connected peripherals from the device. 2. Turn on the power button after 10 seconds. 3. If the problem persists, then contact customer support for further help. Tech: Check SD card on the board, interface board, and then check the cable to the LCD screen panel.




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. CHANGE TO THE CAMERA SCREEN MODE 1. Slide the cover to the left. #4 2. Touch switch #3 below and stay for a couple of seconds till the camera mode appears on the LCD monitor. 3. It is noticed the bright light from the camera hole when the camera mode is activated. #4 4. Insert the BLUE needle holder after charge the needle into the camera lens hole #4 to check the needle tip. If the LCD screen is not changing to the camera mode, 5. Release your finger from the touch switch, and then repeat from #1 - #2. Try to use your thumb instead of index finger. Touch switch and stay for a couple of second till the camera mode screen appears. GO BACK TO PREVIOUS SCREEN 1. Close the slide cover. #4 2. Touch switch #3 and stay for a couple of seconds till the camera mode screen change back to the system ready screen as below. Please refer to Agnes user manual (operation manual) for further information. If the touch switch is not responding or having difficulties, please contact customer support at 844-811-1154.




No Sound - from the touch screen


Please check the system volume control at the rear device panel. Refer to #8 below. Turn volume control clockwise to increase system sound including touch screen click. If still no sound from the device, then check the 'Standby' button. The pulse beep can be heard when Ready button is pressed.




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. If the needle tip is not inserted into the patient skin while the ground plate intact the patient skin, the system alarm will also inform three beeps per pulse because the circuit is not fully connected. Example) = beep beeps




System Failure - Screen not working or blackout, no response, or system freeze


Please follow the following sequence. 1. Turn off the power switch and disconnect all cables except for the power cord from the device. 2. Turn on the power switch and wait for the system booting. 3. Check the LCD screen by tough for the response accordingly. 4. If it is OK, then connect all cables to the device. 5. If not respond, please turn off the power and wait for 30 seconds. Then, turn on the power switch for system booting. If the system is not responding after the above steps, then contact customer support at (844) 811-1154 for the further help.




Adverse Event - Skin burn


Cause: Incomplete insertion or early withdrawl of Agnes Needle. The following example is the case of epidermal burn by the incomplete insertion of needle during the pulse or early withdrawal of the needle tip during the energy pulse. The footswitch must be pulsed after the complete insertion of the needle, by the needle shoulder, and the needle should be withdrawn when the system pulse signal stops. Any multiple pulses or shots in a single needle insertions should be careful to prevent any negative events. The use of Agnes for any aesthetic procedures in the US is considered an off-label procedure. Approved as a general clearance and no indication for any specific procedures under US FDA. K192728




Support - Does Agnes has user operation manual?


To obtain manual or update, please email your inquiries at info@iagnes.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. Botox is the type of protein and it will be destroyed by the heat. Agnes treatment should be prior to Botox injection.




Are metal implants a true contraindication or at the discretion of the provider?


The metal implant is one of the main contraindication to the Agnes procedures. However, the metal implant is not the absolute contraindication to the Agnes procedures depending on the distance from the treatment target and the size of the implant EXCEPT for the cardiac pacemaker. The patient with the dental implant can be scheduled for Agnes procedures unless the patient has other medical contraindications in the body. = implant dental implant contraindication contraindications




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. The user must be aware of the skin temperature can changes the tissue impedence to the radiofrequency energy. Because of this reason, the user should be carefully set the pulse duration and control its number of energy shot in a same needle insertion. The patient safe is always your top priority. = interval needle insertion disfigurement pigmentation




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?


The primary function of Agnes bipolar device is to generate suitable heat to the skin for the post care treatment such as soothing and massaging the treated the area of skin. However, using the bipolar device must NOT apply while the patient skin is desensitized by the topical numbing cream or anesthetic infiltration because the patient cannot feel the temperature from the bipolar tips.




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 info@iagnes.com 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.





Agnes Medical USA, .       All rights reserved.
Tel.  844-811-1154    Email. sales@iagnes.com
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Los Angeles, California