POLLOGEN Legend Pro User manual

Part Number 11600510U ver.7
Legend Pro™
USER MANUAL
Pollogen a company of Lumenis
Proprietary Information
Version 7 September 2019

Legend Pro™System User Manual Version 7
Proprietary Information of Pollogen a company of Lumenis 2
Pollogen a company of Lumenis reserves the right to make changes without notice to its products or
specifications to improve performance, reliability, or manufacturability.
All information supplied by Lumenis Ltd. is believed to be accurate and reliable. However, Lumenis Ltd.
assumes no responsibility for its use. No license is hereby granted by its implication or otherwise under any
patent or patent rights of Lumenis Ltd.
This document, in part or entirety, is not to be produced, reproduced or transmitted in any form or by any
means, electronic or mechanical, for any purpose, without the express written permission of Lumenis Ltd.
Lumenis Ltd. has patents and pending patent applications, trademarks, copyrights, and/or other intellectual
property rights covering the subject matter in this document.
Providing of this document does not give any license to these patents, trademarks, copyrights, and/or other
intellectual property rights unless otherwise expressly provided in any written agreement from Lumenis Ltd.
All data is subject to change without prior notification.
Pollogen Ltd., 6 Kaufman St., PO Box 50320, Tel Aviv 6801298 Israel
Obelis S.A, Boulevard Général Wahis 53 1030 Brussels, BELGIUM
Tel: [phone], Fax: [phone], GSM 32 47545 4660,
e-mail: [e-mail]
Contact Information
Customer satisfaction is a Pollogen priority. To help us in providing you with the best possible product and
support, please send us your comments and suggestions. Contact us at the details below:
Pollogen Ltd.
6 Kaufman St., Gibor House
PO Box 50320
Tel Aviv, Israel 6801298
Telephone: [phone]
Facsimile: [phone]
Web Site: www.pollogen.com
Email: [e-mail]

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Contents
1. INTRODUCTION TO THE SYSTEM .................................................................................................................7
2. SAFETY INSTRUCTIONS.................................................................................................................................7
2.1 Precautionary definitions.....................................................................................................................7
Table 1: Precautionary Symbols and Definitions .........................................................................................7
2.2 Cautions ...................................................................................................................................7
2.3 Warnings ....................................................................................................................................8
2.4 VO and disposable related warnings : .........................................................................................9
2.5 Electrical and Mechanical Safety warnings : ...............................................................................9
2.6 Fire Hazards ............................................................................................................................. 10
3. Safety Features: ........................................................................................................................................ 10
4. INDICATIONS............................................................................................................................................. 11
5. CONTRAINDICATIONS ............................................................................................................................... 11
5.1 PRECAUTIONS ................................................................................................................................... 11
6. POSSIBLE SIDE EFFECTS............................................................................................................................. 12
7. SYSTEM DESCRIPTION............................................................................................................................... 12
7.1 System Components and Controls.................................................................................................... 12
7.1.1 Main Unit (System Console)...................................................................................................... 13
Figure 1: Legend Pro™ Main System Components (Left –front view, Right –back view) ....................... 13
7.1.2 Control Panel:............................................................................................................................ 14
Figure 2: User Interface –Control panel................................................................................................... 14
7.1.3 Back Panel................................................................................................................................. 15
Figure 3:Back Panel................................................................................................................................... 15
7.1.4 Applicator VO - intended for the VoluDerm ™ and TriFractional™ treatments ....................... 15
Figure 4: VO applicator ............................................................................................................................. 15
Figure 5:gen36 tip ..................................................................................................................................... 16
Figure 6:gen12 tip ..................................................................................................................................... 16
Figure 7: gen36L tip................................................................................................................................... 16
Figure 8: gen100 tip .................................................................................................................................. 16
Figure 9: H7X7 tip...................................................................................................................................... 16
7.1.5 Applicator No. 1: ....................................................................................................................... 17

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7.1.6 Applicator No. 2: ....................................................................................................................... 17
7.1.7 Applicator 1 and 2 indicator LED screen................................................................................... 17
7.1.8 Applicator No. 3: ....................................................................................................................... 17
7.1.9 Foot Switch................................................................................................................................ 18
Figure 13: Foot Switch .............................................................................................................................. 18
7.1.10 Patient controlled manual switch:............................................................................................ 18
Figure 14 : Patient controlled manual switch........................................................................................... 18
7.1.11 Non-Contact Infrared Thermometer: ....................................................................................... 19
8. Technical Specifications ............................................................................................................................ 19
Table 2: Technical Specifications .............................................................................................................. 19
9. Symbols & Labels ...................................................................................................................................... 20
9.1 Symbols Used in this User Manual: .................................................................................................. 20
Table 3: Symbols used throughout this User Manual............................................................................... 21
9.2 Labels affixed to the System and its accessories .............................................................................. 21
Table 4: Labels affixed to the System and disposables............................................................................. 27
10. INITIAL SET UP....................................................................................................................................... 28
10.1 Unpacking the System....................................................................................................................... 28
Figure 16: Unpacking the System.............................................................................................................. 28
10.2 General overview and Installation Requirements ............................................................................ 29
10.3 Preparation for Operation ................................................................................................................ 29
10.3.1 Applicator and cable holder’s assembly procedure:................................................................. 29
10.3.2 Foot Switch connection............................................................................................................. 31
10.3.3 Patient-Controlled Manual Switch connection......................................................................... 31
10.3.4 Connect VO Applicator.............................................................................................................. 31
10.3.5 Attach VO disposable tips ......................................................................................................... 32
10.3.6 Connect and lock Applicator No. 1.......................................................................................... 32
10.3.7 Connect and lock Applicator No. 2......................................................................................... 33
10.3.8 Connect and lock Applicator No. 3......................................................................................... 33
10.3.9 Power supply cord connection ................................................................................................. 33
11. USER INTERFACE ................................................................................................................................... 34
11.1 Turning System On............................................................................................................................ 34
11.2 Selecting Treatment Application....................................................................................................... 37
11.3 TriPollar® Treatment Application...................................................................................................... 37
11.3.1 Select TriPollar® Treatment Applicator..................................................................................... 37

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11.3.2 Select TriPollar® treatment course ........................................................................................... 38
11.4 VoluDerm ™ Treatment Application ................................................................................................. 39
11.4.1 Select VO Treatment Applicator ............................................................................................... 39
11.4.2 VoluDerm ™ treatment level .................................................................................................... 39
11.4.3 VO Applicator tips ..................................................................................................................... 40
11.5 Adjusting System’s Default (Preset) Parameters.............................................................................. 41
11.6 Operation.......................................................................................................................................... 41
11.7 Indications......................................................................................................................................... 42
11.7.1 Applicator Indication................................................................................................................. 42
10.7.2 Indication on Touch Screen............................................................................................................ 43
11.8 Settings.............................................................................................................................................. 43
11.8.1 Home screen ............................................................................................................................. 43
11.8.2 Date/Time selection.................................................................................................................. 44
11.8.3 Technician mode....................................................................................................................... 44
11.8.4 Program upload......................................................................................................................... 44
11.8.5 Data Log .................................................................................................................................... 45
11.9 Turning the System OFF.................................................................................................................... 45
12. Legend Pro™ treatment........................................................................................................................ 46
12.1 VoluDerm ™ Treatment using VO applicator.................................................................................... 46
12.1.1 Pre-Treatment Preparation....................................................................................................... 46
12.1.2 Treatment Guidelines: .............................................................................................................. 46
12.1.3 Treatment Parameters.............................................................................................................. 47
Table 5.1: VoluDerm ™ Treatment parameters........................................................................................ 48
12.1.4 Treatment Procedure................................................................................................................ 48
12.1.5 Post Treatment Care ................................................................................................................. 50
12.2 TriPollar® Energy Treatments using Applicators 1, 2, 3.................................................................... 51
12.2.1 Pretreatment guidelines: .......................................................................................................... 51
12.2.2 During the treatment................................................................................................................ 51
12.2.3 Treatment Parameters.............................................................................................................. 52
Table 5: Treatment Parameters for TriPollar®.......................................................................................... 52
Table 6: Typical treatment parameters for face treatment...................................................................... 52
12.2.4 TriPollar® treatment procedure................................................................................................ 52
Pre-Treatment Preparation....................................................................................................................... 52
Performing Treatment Procedure ............................................................................................................. 53

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Post Treatment Care ................................................................................................................................. 54
Treatment Protocol and Conclusion.......................................................................................................... 54
13. MAINTENANCE...................................................................................................................................... 55
13.1 Cleaning the System.......................................................................................................................... 55
13.2 Cleaning the Applicators................................................................................................................... 55
14. FUSE REPLACEMENT ............................................................................................................................. 55
15. Troubleshooting.................................................................................................................................... 56
16. WARRANTY TERMS ............................................................................................................................... 58
17. ELECTROMAGNETIC COMPATIBILITY TABLE SHOWN IN SECTION 5.2.2 IEC 60601-1-2 Ed. 4.0 (2014) 59
18. DIAGRAM FOR THE RF OUTPUT THAT SHOW THE SUBJECT DEVICE POWER OUTPUT VS. OUTPUT
CONTROL........................................................................................................................................................... 60
19. DIAGRAM FOR POWER OUTPUT AT FULL AND HALF FOR THE LOAD RANGE OF 25 - 1,000Ω ............. 60
Figures:
Figure 1: Legend Pro™ Main System Components (Left –front view, Right –back view)............... 13
Figure 2: User Interface –Control panel ............................................................................................ 14
Figure 3:Back Panel............................................................................................................................ 15
Figure 4: VO applicator ...................................................................................................................... 15
Figure 5:gen36 tip............................................................................................................................... 16
Figure 6:gen12 tip............................................................................................................................... 16
Figure 7: gen36L tip............................................................................................................................ 16
Figure 8: gen100 tip............................................................................................................................ 16
Figure 9: H7X7 tip.............................................................................................................................. 16
Figure 10: Applicator No.1................................................................................................................. 17
Figure 11: Applicator No.2................................................................................................................. 17
Figure 12: Applicator No. 3................................................................................................................ 18
Figure 13: Foot Switch........................................................................................................................ 18
Figure 14 : Patient controlled manual switch ..................................................................................... 18
Figure 15: Non-Contact Infrared Thermometer.................................................................................. 19
Figure 16: Unpacking the System....................................................................................................... 28
Tables:
Table 1: Precautionary Symbols and Definitions ................................................................................. 7
Table 2: Technical Specifications....................................................................................................... 19
Table 3: Symbols used throughout this User Manual......................................................................... 21
Table 4: Labels affixed to the System and disposables ...................................................................... 27
Table 5: Treatment Parameters for TriPollar®................................................................................... 52
Table 6: Typical treatment parameters for face treatment.................................................................. 52

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1. INTRODUCTION TO THE SYSTEM
The Legend Pro™ system intended for dermatological procedures requiring ablation and resurfacing of the
skin when using VoluDerm ™ Energy (Applicator VO). It is also intended for use in dermatologic and general
surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when
using TriPollar® RF Energy (Applicators 1-3)
Intended settings for the device: Clinics & Hospitals.
Intended users: Healthcare professionals (Doctors or Nurses)
Legend Pro™ consists of seven main parts: Main Unit, Applicator VO for VoluDermand TriFractional
treatments, Applicators 1-3 for TriPollar® treatments, Foot Switch and Patient-Controlled Manual Switch.
The operator can adjust all system parameters from the user interface on the Main Unit.
2. SAFETY INSTRUCTIONS
2.1 Precautionary definitions
The precautionary instructions found in this section and throughout this manual indicated by specific
symbols. Understand these symbols and their definitions before operating this equipment.
The definitions of these symbols are as follows:
(Warning)
Text with a “WARNING” indicator explains possible safety infractions that may
cause serious injury and equipment damage.
(Caution)
Text with a “CAUTION” indicator explains possible safety infractions that
could have the potential to cause minor to moderate injury or damage to
equipment.
Table 1: Precautionary Symbols and Definitions
The System is designed for safe and reliable treatment when used in accordance with proper operation and
maintenance procedures. The operator and all other personnel operating or maintaining the System should
be familiar with the safety information provided in this chapter.
2.2 Cautions
Read this chapter to become familiar with all the safety requirements and operating procedures prior to
System operation.
In order to protect the Legend Pro™ System from use by unqualified personnel, turn the system off
while the system is not in use and lock it in a secure room.
Do not disconnect any of the system components or accessories while the system is switched on.
Keep the Applicators clean. See cleaning instructions in section 13 of this user manual.
Do not allow the Applicator to come in contact with hard objects that can damage it.
Always keep the System’s wheel breaks locked to avoid uncontrolled movement. When movement is
necessary, unlock the breaks before doing so. Always move the System slowly and carefully. The System
may cause injury if proper care is not taken when moving it.

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Only move the system by using its handle. Pushing or pulling the system without using its handle can
turn the system over and may result in damage to the system.
Switch off the system when moving the unit.
Before connecting the power supply cord, make sure that the ON/OFF switch is in the OFF position (“0”).
Check all connections before plugging in the System’s power supply cord.
Pay attention to the screen quality, to ensure that it is acceptable during the first few seconds of the
system check (touch screen becomes active). At this time, the Applicator's LED flashes (first green then
orange) as part of the System’s self-check. In case of display failure, stop system operation.
In case of uncertainty regarding potential side effects, have the patients consult their physician and
bring consent for treatment.
Restart the system in the event that a wrong or incomplete program upload occurred while uploading
the program version using the USB memory stick.
Make sure that the counter on the display is stopped when the foot switch is released.
Patients should remove all jewelry prior to treatment.
Do not use Legend Pro™ System in close proximity to a short-wave or microwave therapy equipment.
Before every treatment, verify that the applicator is intact.
Make sure to replace the applicator if it falls before, during or after a treatment.
Always use tips which were approved and supplied by Lumenis or its legal representatives.
When treating with TriPollar® programs, patients should remove all jewelry prior to treatment
2.3 Warnings
Before attempting to operate the Legend Pro™ System, be sure to read this manual to become familiar
with all safety requirements and operating procedures.
No modification of this equipment is allowed!
When treating facial area, never treat the area below the eyebrow & never treat over the eye lids &
eyes themselves. Never treat over the lips. Do not treat genitals, the chest, breasts or underarms.
Do not connect a patient to High Frequency surgical equipment during treatment.
Treatment should not be applied over swollen, infected, inflamed areas or skin eruptions.
Verify that fan is functioning when operating the System. In case of fan failure do not operate the
device, call your Lumenis representative for service.
Do not operate the unit in the presence of electromagnetic interference. Electromagnetic interference
may be caused by electro surgery, diathermy, magnetic resonance imaging or other type of equipment.
Portable and mobile are RF communication equipment & may affect the operation of this device.
Using power that is higher than needed can cause over-treatment of the skin.
When treating with TriPollar® programs, do not treat using mineral oils.
When treating with TriPollar® programs, do not heat the skin over 43ᵒC (109.4ᵒF).
Treatment should not be applied over, or in proximity to, cancerous lesions.
When treating with TriPollar® programs, to avoid the risk of potential burns, applicator must always be
in constant movement while in contact with the skin. Never stop applicator movement while in contact
with the patient.
There may be risks associated with bipolar RF energy delivery to the skin that are yet unknown. Any
procedure perforating the skin can cause discomfort, pain, bleeding, infection, swelling, edema, scar
formation, permanent marking, and pigment alteration. Therefore, potential risks which could result
from RF and electrode insertion include discomfort during and after the procedure, pain, infection,
scarring, swelling or edema, and permanent discoloration.
Do not allow patients to contact metal surfaces.
The Applicator should be used at least 1 cm away from a cochlear implant.
Check device for any damage prior to use.
Do not activate the applicator when it is not in contact with the patient’s skin.
Discontinue use immediately in case of excessive heat or burning sensation.

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Do not treat the area near the thorax which may increase the risk of cardiac fibrillation.
Never treat over the eye socket, the chest, breasts or underarms.
Never treat over the thyroid area.
Patient should not come into contact with earthed metal parts or parts with appreciable capacitance to
earth.
Regularly inspect the accessories for possible damage; in particular, electrode cables and HF energized
devices.
2.4 VO and disposable related warnings :
Never direct the Applicator’s tip at anything other than the treatment site.
Reuse of single-use disposable tips creates a potential risk of self or cross-contamination and infection
which may each lead to significant medical complications. Do not treat another patient with the same
tip.
Do not allow the Applicator to come in contact with hard materials that could damage the tip.
Place the tip perpendicular to the skin with full contact, applying slight pressure.
Ensure that the Applicator’s tip is free of debris and thoroughly dry.
No lotion, gel, oil or glycerin is used when treating with the VO Applicator. Verify clean & dry skin.
Always discard the tip at the end of patient’s treatment as biological hazardous waste.
Do not use a tip if its expiry date is overdue.
Do not use a tip if its package is compromised. Verify package integrity before use.
Always check the integrity of the tip. Verify that all the electrodes are present. If any pins are missing, do
not use the tip.
Ensure that the tip is clean during treatment. Accumulated debris or non-dry skin may cause pain and
skin damage.
During treatment inspect the tip’s integrity and cleanliness once every 10 to 15 pulses. This is especially
important when using high parameters, which may cause increased buildup of debris. If the tip is not
clean it must be replaced.
After VO treatment, no other treatment should be performed until the treated area has completely
healed.
To protect from unwanted contact of the electrode pins, make sure to secure the tip using its protective
cover when not in use.
2.5 Electrical and Mechanical Safety warnings :
High voltage is present inside the Legend Pro™ System. Always take proper precautions as described in
this manual, while making sure to constantly be aware of the possible dangers.
Only qualified personnel that have been trained by Lumenis® are allowed to supply service to this
equipment.
Do not touch the inner parts of the system; service is supplied only by company’s authorized personnel.
To avoid risk of electric shock, this equipment must only be connected to a supply main with protective
earth and must be used with the cable supplied. (cable10A, 250V, 1.8m length). The system is grounded
through the grounding conductor in the power cable. This protective grounding is essential for safe
operation.
Keep all covers and panels of the System securely closed at all times when in use. Removal of the covers
or panels can create a safety hazard.
Perform maintenance procedures when the System is shut down and disconnected from power outlets.
Always keep the System’s wheel breaks locked to avoid uncontrolled movement. When movement is
necessary, unlock the breaks before doing so. Always move the System slowly and carefully. The System
may cause injury if proper care is not taken when moving it.

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The System is grounded through the grounding conductor inside the power cable. This protective
grounding is essential for safe operation.
Verify fan operation when operating the device and stop device operation when fan is not operating.
Verify that once the Foot Switch is released, the treatment will stop and the counter on touch screen
will stop as well
2.6 Fire Hazards
Do not use the System in the presence of explosive or highly flammable materials like alcohol, methanol,
acetone, etc. (The suggested use of the Glycerin for TriPollar® treatments is in no way an explosive or
highly flammable material and is approved for usage).
Do not have flammable substances in the treatment room when preparing the skin for treatment.
If alcohol is used for cleaning, it must be allowed to dry thoroughly before the System is used. The
container of alcohol must be moved away from the System.
3. Safety Features:
The System is designed for safe and reliable treatment when used in accordance with proper
operation and maintenance procedures. The operator and all other personnel operating or
maintaining the System should be familiar with the safety information provided in this chapter.
•All Applicators must be connected to the system and locked prior to activation.
•To start the treatment, the Foot Switch must be pressed down by the operator. Output is emitted
only after pressing the Foot Switch.
•No RF signal is delivered to the VO Applicator unless a treatment Tip is connected to the
Applicator.
•The VO Tip electrode matrix in contact with tissue is pre-sterilized and designed for single use to
avoid cross contamination.
•Patient-Controlled Manual Switch of sensation automatically terminates application of RF energy
when pressed.
•The system automatically identifies the type of tip connected.
•An independent electronic circuit stops the operation of the system in case of a software error.
•After each press and release of the Foot Switch, the LED indicator guide ring turns Green. LED
Indicator guide ring will turn Orange when the Foot Switch is pressed and treatment pulse power
is transmitted to the electrodes. After treatment termination, the LED indicator guide ring will
turn green and ONLY then, the operator can release the foot switch.