GENEO RF PRO User Manual

Handpiece kit for geneo x u system

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RF PRO HANDPIECE KIT FOR

GENEO®

X U SYSTEM

The above picture depicts the

GENEO®

X U system with Oxfoliation

and RF Pro handpieces.

This user manual is dedicated to the RF Pro Handpiece Upgrade Kit for the USA configuration

of the GENEO X device (in short "GENEO X U"). For ease of readability the device is simply

referred to as 'GENEO X' predominantly throughout this user manual.

Pollogen's Proprietary Information

P/N 11600910U / REV. 03 / Pollogen Ltd. / December 2024

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Summary of Contents for GENEO RF PRO

Page 1 This user manual is dedicated to the RF Pro Handpiece Upgrade Kit for the USA configuration of the GENEO X device (in short “GENEO X U”). For ease of readability the device is simply referred to as ‘GENEO X’ predominantly throughout this user manual.
Page 2: Table Of Contents
Table of Contents Chapter Page No. About the GENEO X system Intended use Intended users Intended use environment Glossary of Symbols Used in GENEO X Labels & User Manual Technical Specifications Safety Instructions and Contraindications Precautionary definitions Warnings Fire Hazards Cautions...
Page 3: About The Geneo X System
- the epidermis. GENEO X RF Pro uses a mild energy source (6 Watts) that gently heats the skin and treats the wrinkles to beautify the skin. GENEO X system provides a non-invasive and non-ablative skin beautification treatment.
Page 4: Glossary Of Symbols Used In Geneo X Labels & User Manual
Glossary of Symbols Used In GENEO X Labels & User Manual This table explains the symbols used in the GENEO X labels and User Manual. It is recommended to review the meaning of these symbols. Symbol Description SEE INSTRUCTIONS FOR USE...
Page 5: Technical Specifications
Technical Specifications Performance Specifications RF Pro Handpiece Output Power 6W @ 200 OHM RF Pro Handpiece RF Frequency 1MHz Product Lifetime: 5 years Environmental Conditions for Operation: Operating Temperature: +5°C – +30°C Operating Humidity: 20 – 80% RH Atmospheric Pressure:...
Page 6: Safety Instructions And Contraindications
OFF when not in use. • Before attempting to operate the GENEO X system, be sure to read this manual and become familiar with all safety requirements and operating procedures. Question the participants about the contraindications to determine participant suitability for the treatment.
Page 7: Fire Hazards
Do not have flammable substances in the treatment room while preparing the skin for treatment. • If alcohol is used for disinfection, it should be allowed to dry thoroughly before the GENEO X is used and then set a distance from the system.
Page 8: Cautions
• As per practitioner’s discretion, refrain from treating any condition which may be unsafe for customer. In addition, do not perform RF Pro treatments on a person who has one or more of the following conditions: • Pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric system.
Page 9: Additional Precautions
(types V or VI) or may be prone to skin discoloration has not been established. ADDITIONAL PRECAUTIONS Special caution should be taken in following cases using GENEO X System: • Customers taking medications, herbal preparations, food supplements or vitamins that might cause fragile or impaired skin healing such as prolonged steroid regime, tetracyclines, or St.
Page 10: Geneo X Packaging Configuration
(Fig. 2) RF Pro Handpiece Kit Content List: RF Pro Handpiece (Fig. 7) Handpiece Cradle (Fig. 4) 3. User Manual (Fig. 7) RF Pro Preparation Gel: RF Pro Preparation Gel is purchased stand-alone and may be provided in a separate box.
Page 11: Unpacking And Initial Set Up
Follow these steps for simple plug and play set up: Step 1 – placing the system: Place the GENEO X main unit on a stable surface which can support the weight of the system, which is about 9Kg (~20 lbs.). Step 2 – placing the cradles: The screen mounted cradle Holder (for simplicity “holder”) has round marks on its top panel to indicate cradle positions...
Page 12 Place the supplied screw on the top of the screwdriver tip and align in below the threaded insert in the button of the cradle. Insert the screw and twist it clockwise to tighten the connection. (Fig. 11). Be careful not to damage the screen while doing so! Verify that the cradle is locked in place.
Page 13 Have the front of the system facing you and place the Oxfoliation handpiece in the right cradle with its treatment head facing up. Place the RF Pro handpiece in the left cradle with its treatment head facing up, as shown in (Fig. 13).
Page 14 An automatic short sequence of system check-up will take place each time the system is turned on. During check-up all handpiece LEDS light up in green, the GENEO X logo appears on the screen and the Oxfoliation motor will make a short sound. Once the home screen is loaded, the system is ready for use (home screen depicted is Fig.
Page 15: Preparation For Treatment
Verify eligibility for RF Pro Treatment according to Fitzpatrick scale of skin type (Fig. 18) and facial wrinkles severity (Fig. 19): The System should be used on customers with skin types 1,2,3,4 on the Fitzpatrick scale only: Fig.
Page 16: Getting To Know The Rf Pro Handpiece
Getting to know the RF Pro Handpiece GENEO X RF Pro technology delivers thermal energy (heat) through four electrodes into the deep layers of the skin to trigger collagen remodeling. The treatment effect is reduction of wrinkles appearance and improvement of skin tone and texture. RF Pro technology selectively delivers heat into the skin, without damaging the epidermis.
Page 17: Rf Pro Treatment Procedure
The maximum RF output power of the system remains constant. The optimal skin temperature for the treatment will be reached when the ORANGE LED light turns ON. RF Pro has 1 pre-defined default operating level of 100% RF output power and a default duration of 20 minutes. RF Pro RF Treatment Procedure...
Page 18 “EXP.”. Note: Before first treatment with the RF Pro Preparation Gel, perform a patch test with the gel on a small area of skin (Forearm, 2"x2"). This will ensure the skin does not have a negative reaction (excessive redness and/or swelling) to the gel.
Page 19 RF Pro Handpiece into the handpiece cradle holder. Select the RF Pro Handpiece from the Cradle (Fig. 27), press the “start” button on the handpiece (circled in Fig. 28) to switch it ON and begin treatment. The light will change from GREEN LED to BLUE indicating the handpiece is active. The remaining time will show inside a circle on screen (Fig.
Page 20 Press EDIT to revert to the RF Pro treatment screen for change of duration settings on the screen with options to EDIT or continue treatment. Press EDIT to revert to the RF Pro treatment screen for change of...
Page 21: Post Treatment Care
Upon completion of the treatment, remove the remaining preparation gel from the skin. You may consider using a dry tissue to absorb the excess gel, then thoroughly cleansing the skin using a gentle cleanser and wet towel (Fig. 33-34). Fig. 33 Fig.
Page 22: Care And Maintenance
CARE AND MAINTENANCE GENEO X is an electrical system, do not to spill any liquids on it nor clean under running water. When not in use, protect the system from dust and store system’s components in a cool and dry place.
Page 23: Troubleshooting
Troubleshooting Error Message on Failure Possible Cause of Failure Action screen No text or Communication Switch the system OFF and then switch it ON display on touch problem again. If there is still no display on touch screen, screen please contact service center No backlight on AC/DC power supply failure Switch the system OFF and then switch it ON again.
Page 24: Customer Support
Within its validity term, you are entitled to make use of the warranty, if necessary, to have a fully enjoyable product, provided the above-indicated conditions are fully met. This warranty is valid for the GENEO X U® system marketed by the distributor in your...
Page 25 The Warranty Is Not Valid When • Amendments done to the warranty policy, sales receipt or invoice, or the absence of any of these original documents. • Damage or deterioration of the system due to improper use or if the system has been modified or repaired by an unauthorized third party.
Page 26: Appendix A: Output Power Versus Load
Appendix A: Output Power Versus Load...
Page 27: Appendix B: Emc Compatibility
Appendix B: EMC Compatibility Electromagnetic compatibility table IEC 60601 -1- 2:2014 + AMD 1:2021 Geneo X U...
Page 30: Appendix C: Clinical Trials Information
Appendix C: Clinical Trials Information The benefits and risks of Pollogen’s STOP U system, which the GENEO X RF Pro is based on, were tested in a clinical study involving 40 participants, ages 35-65, in two sites within the United States, led by two investigators. Participants received 8 treatments by practitioners on the skin of their face for a 6-week period and there was follow up at 1 and 3 months after the last treatment.
Page 31: Appendix D: Customer Screening Checklist
Does not have any surgical, invasive, ablative procedure on treated area before complete healing. �� Does not have any condition which may be unsafe for customer (per practitioner’s discretion). SPECIFIC TO RF PRO TREATMENTS �� Does not have pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric system.
Page 32 ADDITIONAL PRECAUTIONS �� Aestheticians should not apply topical anesthetic before treatment and also verify the customer did not use topical anesthetic. �� Is not taking medications, herbal preparations, food supplements or vitamins that might cause fragile or impaired skin healing such as prolonged steroid regime, tetracyclines, or St.
Page 33 Fax: +32(0)2 7326003 Email: mail@obelis.net GENEO and Pollogen are registered trademarks of Pollogen Ltd. and are proprietary technologies of Pollogen Ltd. Customer satisfaction is our priority. To help us provide you with the best possible product and support, please send us your comments and suggestions.