VENUS CONCEPT NeoGraft 2.0 User manual

NeoGraft 2.0®
User Manual
Document part number: MED011XN101-C0, September 2021

NeoGraft 2.0® User Manual
Document part number: MED011XN101-C0
September 2021
Copyright © 2021 Venus Concept USA Inc. All
rights reserved

NeoGraft 2.0® User Manual
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Chapter 1
About this Manual
Chapter Contents:
Section Title Page
1.1. Use of the Manual....................................................... 1-2
1.2. Scope of the Manual................................................... 1-4
1.3. Document Conventions............................................... 1-6
1.4. Symbols ...................................................................... 1-7

About this Manual
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NeoGraft 2.0® User Manual
1.1. Use of the Manual
Warning
• Use of controls or adjustments, or performance of
procedures other than those specified herein, may be
hazardous and are not authorized by the manufacturer.
• Personnel operating or maintaining the system are required
to read this manual and to become thoroughly familiar with
all its safety requirements and operating procedures before
attempting to use or operate the system.
• This User Manual is an integral part of the medical device
and should be retained throughout the life cycle of the
device. Documentation may be discarded once the device is
upgraded or replaced and as long as there were no incidents
regarding the safety and effectiveness of the device.
• It is unsafe to start using the device before reading and
understanding the entire User Manual.
• The user should make sure that he/she has qualifications and
training in the proper use of the device, and is familiar with
the indications, contra-indications and operating procedures
recommended in this User Manual.

About this Manual
NeoGraft 2.0® User Manual
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Please read the entire User Manual before trying to operate the
device.
This manual has been prepared to aid medical and technical
personnel to understand and operate the system. Do not operate the
system before reading this manual and gaining a clear
understanding of system operation. If any part of this manual is not
clear, contact your Venus Concept representative for clarification.
This manual should always accompany the system, and all
personnel operating the system must know its location.
The operating instructions of your device are provided
electronically and not on paper. Nevertheless, it is possible to
obtain a printed copy upon request, by telephone or by mail, from
your Venus Concept representative.
If you decide to loan or sell the equipment, its documentation must
be provided with the medical device.

About this Manual
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NeoGraft 2.0® User Manual
1.2. Scope of the Manual
This User Manual includes:
• Chapter 1: About this Manual
Provides information on the use and scope of the manual,
document conventions, and a list of the used symbols.
• Chapter 2: Safety and Regulatory Information
Provides general safety and regulatory information on the
system, its intended use, possible hazards, and compliance with
international standards, and shows the system's identification
label.
• Chapter 3: Installation
Provides information regarding the system installation, and its
electrical and environmental requirements, equipment list,
electrical connection and installation of handpieces and other
system parts and accessories.
• Chapter 4: System Description
Describes the system's main components and their descriptions.
• Chapter 5: Operating Instructions
Provides detailed instructions on how to operate the system and
describes its main interfaces.
• Chapter 6: Advanced Features and Settings
Provides detailed information on the Properties screen and its
features.

About this Manual
NeoGraft 2.0® User Manual
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• Chapter 7: Care and Maintenance
Provides information on general user care and maintenance,
including cleaning instructions.
• Chapter 8: Troubleshooting
Provides solutions to some problems that may arise while
operating the system.
• Chapter 9: Specifications
Provides a detailed list of the system's technical information and
specifications.
• Appendix A: Clinical Guide
Provides a clinical guide and detailed information on how to
use the device to perform the hair transplantation.
• Appendix B: Manufacturer Warranty
Provides the manufacturer warranty information.

About this Manual
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NeoGraft 2.0® User Manual
Warning
Warnings indicate precautions and instructions which, if not
followed, may result in injury.
Caution
Cautions indicate instructions, that if not followed may result in
damage to the equipment or to the quality of treatment.
1.3. Document Conventions
The following messages in this manual prompt the reader to pay
special attention to specific points:
Note
Notes provide information to aid in obtaining
optimum equipment performance or procedure
results.

About this Manual
NeoGraft 2.0® User Manual
1-7
1.4. Symbols
Table 1-1 describes the symbols that are used in this manual or on
the product.
Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Symbol
Description
Waste of Electrical and Electronic Equipment
(WEEE) Marking
Type B equipment
Manufacturer (accompanied by the name and
address of the manufacturer)
Date of manufacture
Country of manufacture
Consult Instruction for Use.
Temperature limits
Mobile device weight
36kg

About this Manual
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NeoGraft 2.0® User Manual
Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Keep dry.
Do not use if the packaging was damaged or
opened.
Device reference
Device serial number
Device batch number
Expiration date
Do not re-use, single use, use only once
Sterilized with ethylene oxide
Sterilized by radiation
Indication that the device has not been sterilized
The device can be machine washed

About this Manual
NeoGraft 2.0® User Manual
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Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Indication that the device should be steam-
sterilized at 134°C or 135°C in a pre-vacuum air
removal autoclave
Protective earth
Fuse
Alternating current
Do not tilt: risk of tipping
Non-ionizing electromagnetic radiation
O/I
Switch Off/On
"Conformité Européene" Symbol (CE Marking)
Warning:
A Warning alerts the user to the possibility of
serious injury, death, or serious adverse reactions
associated with the use or misuse of the system.

About this Manual
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NeoGraft 2.0® User Manual
Table 1-1. Glossary of Symbols Used in this Manual or on the
Product
Caution:
A Caution alerts the user to the possibility of a
potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to
the user or damage to the equipment.

NeoGraft 2.0® User Manual
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Chapter 2
Safety and Regulatory
Information
Chapter Contents:
Section Title Page
2.1. Introduction................................................................. 2-2
2.2. Intended Use............................................................... 2-3
2.3. Training and Guidance................................................ 2-3
2.4. Manufacturer's Liability.............................................. 2-4
2.5. Safety Information...................................................... 2-5
2.6. Electrical and Mechanical Safety ............................. 2-10
2.7. Fire Safety................................................................. 2-11
2.8. Disposal and Recycling ............................................ 2-11
2.9. System Label............................................................. 2-12
2.10. Contact Information.................................................. 2-13

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NeoGraft 2.0® User Manual
Safety and Regulatory Information
Warning
Read this chapter carefully to be familiar with all of safety
requirements and procedures prior to operating the system.
2.1. Introduction
The system is designed for a safe and reliable treatment when used
in accordance with proper operating and maintenance procedures
as outlined in this manual. Only qualified personnel, trained by an
authorized trainer, can use the system and perform the treatments.
The operator and all other personnel operating or maintaining the
system should be familiar with all of the safety information
provided in this manual.
The primary objective should always be in maximizing the safety
of both the patient and the treatment operator.
You should carefully read the User Manual instructions before
installing or using the system to become familiar with all safety
requirements and operating procedures, and thereby prevent
accidents, injury and reduce the risk of damaging the machine.
The NeoGraft 2.0® system is designed for professional use only.
The manufacturer cannot be held responsible for damage or injury
caused by improper use or for uses other than those for which this
machine is intended.

Safety and Regulatory Information
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2.2. Intended Use
The NeoGraft 2.0® is a surgical instrument, composed of motors
and accessories, and is indicated for use during surgical procedures
for cutting soft tissues.
The NeoGraft 2.0® is intended for suction-assisted follicular
extraction and re-implantation of autografts.
2.3. Training and Guidance
The user must receive proper clinical and technical training from
the distributor or its authorized dealer before operating the device.
This device is intended particularly for high-level health care
professionals, e.g. plastic surgeons, dermatologists and cosmetic
doctors. Nonetheless, in certain countries, some hair transplant
operations can be performed by assistants or by trained nurses.
Venus Concept disclaims any responsibility for any problem
resulting from using a different protocol than the one outlined in
this User Manual.
In case of any doubt or questions on hair transplant by F.U.E.
(Follicular Unit Extraction), contact your authorized distributor.

Safety and Regulatory Information
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NeoGraft 2.0® User Manual
2.4. Manufacturer's Liability
The manufacturer cannot accept liability in the following
conditions:
• Failure to comply with the of the manufacturer's
recommendations (including the electrical and environmental
requirements) when installing the system
• Any service or repair performed by unauthorized persons
• The use of an electrical installation not in accordance with
regulations
• Use of accessories, consumables or spare parts other than those
supplied by Venus Concept or its official distributor
• Non-compliance with the instructions in this User Manual
Note
The manufacturer reserves the right to change
the device and/or documentation without
notice.

Safety and Regulatory Information
NeoGraft 2.0® User Manual
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Warning
• Personnel operating or maintaining the system are required
to read this manual and to become thoroughly familiar with
all its safety requirements and operating procedures before
attempting to use or operate the system.
• The system should be protected against unauthorized use.
• High voltage is present inside the system. Do not attempt to
open its casing.
• Always be aware of the possible dangers of using the system
and take proper precautions as described in this manual.
• The system must be serviced by Venus Concept and/or its
official distributor authorized service personnel only.
2.5. Safety Information
• All operators must be familiar with the system controls and
know how to shut down the system in case of a problem.
• Do not touch the inner parts of the system. The system services
and repairs must be performed by qualified personnel only.
Failure to do so will void all service agreements.
• Disconnect the system from the mains power supply before
servicing (pull out the plug from the electricity socket).
• Do not use the system unless all enclosure panels are properly
in place.
• Do not tamper with the controls or attempt to open up the
system.
• Do not abuse, sit or lean on the system.

Safety and Regulatory Information
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NeoGraft 2.0® User Manual
• A patient history should be completed prior to treatment to
ensure that no complications could arise. It is important to
verify that the patient does not fall under the exclusion criteria.
• The product should not be in contact with other equipment.
• For patients with cardiac pacemakers or other active implants, a
possible hazard exists because interference with the action of
the pacemakers may occur, or the pacemaker may be damaged.
In case of doubt, approved qualification advice should be
obtained.
• The patient should be fully informed of the treatment protocol
and the expected results, and should sign the informed consent
form prior to beginning of the treatments.
• Grafts donor and receiver site belongs to the SAME patient.
• Only authorized persons are allowed to stand near the system
during the treatment.
• Stop the treatment in case of unexpected changes in the patient's
condition.
• Do not drop the handpieces. If a handpiece is dropped, turn off
the system immediately. Do not use a broken handpiece and call
the local service representative.
• There are no user-serviceable parts inside the system. ONLY
VENUS CONCEPT PERSONNEL MAY SERVICE THE
SYSTEM, ESPECIALLY INSIDE ITS CABINET.

Safety and Regulatory Information
NeoGraft 2.0® User Manual
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2.5.1. Environmental Conditions
• Do not use or store the device in a wet environment (humidity
of between 30% and 60%).
• Respect storage temperature between -10°C (14°F) and 50°C
(122°F)
• Do not use the device in an electrical or electro-magnetic
radiation environment that does not comply with the applicable
regulations and standards.
• Do not overload an electrical outlet.
• The power cable must be plugged into an appropriate outlet that
is properly installed and grounded in accordance with local
codes and ordinances.
• Ensure that the device cords do not interfere with the movement
of the system or persons.
• When the device is not in use, or in case of emergency, unplug
the power cable from the mains outlet.
• Operating altitude should be lower than 2000 meters.
• Do not place the device near a radiator or other heat sources.
• Do not place the device against the wall, cabinets or other
furniture.
• Place the device on a level and horizontal floor.

Safety and Regulatory Information
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NeoGraft 2.0® User Manual
2.5.2. Device and its Accessories
• Stop using the device if a system malfunction or operating
problem occurs.
• Always use the system's wheel brakes to stop it from moving
and/or falling.
• When moving the device, make sure to disconnect its power
cable and footswitches.
• Do not block or place any object within 4 cm of the system's
ventilation openings.
• The extracting, the implanting and the incision handpieces are
of B type. During the surgery, the user should not be in contact
with any other electrical devices.
2.5.3. Maintenance
• Make sure that the person in charge of the maintenance has the
necessary skills to conduct servicing of the device and strictly
follows the procedures described in this manual.
• No maintenance procedures, other than those specified in this
manual, are permitted.
• Lifetime of the device is five years, with maintenance every
two years.