FAQ

General Questions

Are there any contraindications for Agnes procedures?

Yes, do NOT schedule Agnes procedures on patients with the following conditions: Pregnancy, Uncontrolled diabetes, various infectious diseases, pacemaker, certain metal implants, or other reasons not recommended by a primary care physician.

How long after filler or Botox injections can I do Agnes treatment?

It is recommended that patients schedule Agnes treatments at least a week after any filler injections. Although filler has resistance to thermal energy, it is always recommended to leave some time in between filler injections and Agnes RF treatments. Botox, however, is a type of protein and it will be destroyed by the heat of the Agnes treatment. It is recommended that Agnes treatments should be scheduled prior to Botox injections.

Is Agnes safe for all skin types and skin tones?

Agnes is a radiofrequency microneedling device for any type of skin. Agnes has nine different types of microneedles and each type has different insulation for each specific procedure to ensure the procedure goes as safely as possible. Although Agnes RF is safer in all skin types compared to laser devices, any significant heat can result in an increased risk of post-inflammatory hyperpigmentation or adverse events at any time.

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

Could we cause disfigurement if the areas treated with each needle insertion are too close?

The average interval between needle insertions should be 3 - 5 mm apart. If the needle insertions are too close to each other, it may cause severe skin burn and aggravate swelling after the treatment because of the accumulated heat.

The user must be aware of skin temperature changes the tissue impedance. Because of this reason, the user should carefully set the pulse duration and control the number of energy watts in the needle insertion. The patient’s safety is always your top priority.

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?

The Agnes RF unit can stay powered on in between patients. However, it is recommended to turn off the device during extended periods of time such as more than a couple of hours.

Is it ok to use the RF Skin Booster right after the monopolar treatment?

The primary function of the Agnes RF Skin Booster is to generate suitable heat to soothe and massage the treated area of the skin. However, you must NOT use the RF Skin Booster while the patient is still desensitized from topical numbing creams or anesthetic infiltration. The patient will not be able to feel the temperature of the RF Skin Booster which can cause adverse effects.

How relevant is recent sun exposure on Agnes RF treatment?

Prior to treatment, it is irrelevant to Agnes treatments but after receiving such treatments, patients should try to avoid intentional and direct sunlight for 48 hours.

What functions does the RF Skin Booster have and what does it do for the patient?

The RF Skin Booster is beneficial in post-care use. It uses mild heat to melt away debris and fat coagulation into the body. Please refer to the user manual for the detail.

What is the difference between 1Mhz and 5Mhz in Radio Frequency devices? and why does Agnes RF use 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 the 5MHz will heat the soft tissue or the target tissue faster. While 1MHz will be relatively slower in 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. Basically, the 5MHZ heats up faster but has less coverage while the 1MHZ takes a bit longer to heat up more of the surrounding area.
Ex) Syneron Profound 0.5MHz, Agnes RF 1.0MHz, Scarlet 2.0MHz, Thermage 6.5MHz

Can we sterilize the monopolar and bipolar handpieces?

The Bipolar handpiece and header can easily be cleaned with alcohol swabs. However, the monopolar needle holder should be sterilized in an autoclave at a temperature of 121 ° C for 30 mins.

If it is not properly cleaned, 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.

Needle

What kinds of Agnes RF needles are available?

There are nine different types of micro-insulated needles, and each type has a unique size and shapes for different procedures. Needle tip lengths and the proximal insulations vary from type to type. For all the details, please refer to the user reference manual or go to How It Works on our website for the detail.

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 device industries and is harmless to the human body.

Is it possible to reuse the needle on the same patient?

All types of Agnes micro-insulated needles are single-use only and not intended for reuse.

There is an increased possibility of infection from multiple uses and an increased risk of a severe skin burn from the damaged insulation if reused.

Camera

What is the main function of the camera?

Agnes has an internal camera unit to inspect the micro-insulated needle.
The function of the camera unit is:
• To ensure the insulated coating on the needle or the tip is free from damage before use.
• To ensure the needle tip is not bent from contact on bone or any other physical damage during the treatment procedure.

Troubleshooting

No energy from the device

Please proceed with the following steps.

1. Check the ground pad to see if it is placed on the patient skin properly.
2. Check the footswitch connection to see if it is securely connected.
3. Check cables and connections to see if they are properly engaged by its color accordingly.
4. Check the LCD screen to see if the mode is set to Standby or Ready.

If the device is still not working, please contact our technical support at (844) 811-1154 M – F, 8:30 AM – 5:30 PM, Pacific Standard Time.

From the device initial booting, the loading screen appeared. However, it does not show the 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 to reboot.
5. Check the touch button on the LCD screen to see if it responds.
6. If the LCD screen is okay and responding, 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 a different wall power outlet. Do not connect to a power extension outlet.
9. Repeat the above steps 1 through 6.
10. If the monitor is still not responding, then contact technical support at (844) 811-1154 for further help.

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 to reboot.
3. Check the LCD screen by touching and wait for the response.
4. If it is okay and responsive, reconnect all cables to the device.
5. If the device is not responsive, please turn off the power and wait for 30 seconds. Then, turn on the power switch and reboot the system.

If the system is still not responding after the above steps, then contact technical support at (844) 811-1154 for further help.

Screen is not working / "Cannot switch to screen mode!"

The touch switch for the camera can be easily activated by touching it with your thumb or index finger for 3 seconds.

CHANGE TO CAMERA SCREEN MODE – Reference image below
1. Slide the plastic camera cover (#4) to the left.
2. Touch the camera switch (#3) and press for a couple of seconds until the camera mode appears on the LCD monitor.
3. You will be able to notice a bright light from the camera hole (#4) when the camera mode is activated.
4. Insert the BLUE needle holder into the camera hole (#4) to check the needle tip.

If the LCD screen is not changing to camera mode:
1. Release your finger from the touch switch, and then repeat steps #1 - #2. Try to use your thumb instead of index finger.
2. Press the touch switch and stay for a couple of second until the camera mode screen appears.

GO BACK TO PREVIOUS SCREEN FROM CAMERA SCREEN MODE
1. Close the plastic camera cover (#4).
2. Touch the camera switch (#3) and press for 3 seconds until the camera mode screen changes back to the previous screen.

Support

How can I get product support?

Please find the form ‘Technical Support Request’ on our website and fill out the detailed description of the problem. If you can take pictures or make a video clip for the problem, it will help us to locate the issue without delay.

Depending on the issues, you may be required to fill out the RMA form for the repair or exchange process.

Who should I contact for questions and product support?

Our goal is to provide the best user support and clinical resources that are essential to use Agnes RF with safe procedures for the best results. Email your questions to in**@ia****.com or call (844) 811-1154 to contact our customer support. For product purchases in the US, please contact Aesthetic Management Partners at (877) 267-2670 for further help.

Warranty

Who is responsible for the shipping cost for repairs?

In case your device needs to be delivered to our facility for any repairs, the shipping cost will be paid by either the manufacturer or customer depending on the issue.

If the repair issue is caused by a device system problem within the warranty period, the manufacturer will be responsible for the shipping and labor cost without charging you.

However, if the problem is caused by the user's own misuse, the user will be responsible for the shipping and labor cost. Please contact our product support at in**@ia****.com or call (844) 811-1154 for more details.

AGNES provides a two-year limited system warranty for repairs and free system upgrades. Please check with your local sales rep for additional details.

Device warranty?

Agnes Medical provides a two-year manufacturer’s limited coverage for the main Agnes device and a one-year coverage on accessories and consumables. The warranty is only upheld if the user fills out and submits the warranty registration include in the User Manual found inside the product box or registers Product Warranty Registration under Portal Access on this website. If the form is submitted or registered your Agnes device via our website within 30 days of receiving the system, Agnes Medical will provide one(1) complimentary box of needles for your choice. For the extended warranty information, please contact a sales representative by phone or email. In the event that the user should require replacement parts, please fill out Tech Support under the Portal Access or contact us to receive prompt assistance from our technical support team. For technical support, device pricing, and other additional information, please contact us at (844) 811-1154 or email us at in**@ia****.com.