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VENUS CONCEPT NeoGraft 2.0 - User Manual

VENUS CONCEPT NeoGraft 2.0
210 pages
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NeoGraft 2.0
®
User Manual
Document part number: MED011XN101-C0, September 2021

Table of Contents

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Summary

About this Manual

Use of the Manual

Information on the use and scope of the manual, document conventions, and symbols.

Scope of the Manual

Details the content covered in each chapter of the user manual.

Document Conventions

Explains the meaning of warning, caution, and note messages used in the manual.

Symbols

Glossary of symbols used in the manual and on the product.

Safety and Regulatory Information

Introduction

Overview of system safety requirements and operating procedures.

Intended Use

Specifies the device's purpose as a surgical instrument for hair transplantation.

Training and Guidance

Highlights the need for proper clinical and technical training for users.

Manufacturers Liability

Outlines conditions under which the manufacturer is not liable for damages or injuries.

Safety Information

Provides essential safety precautions for operating and maintaining the system.

Electrical and Mechanical Safety

Details safety measures related to the system's electrical and mechanical aspects.

Fire Safety

Addresses risks of fire and precautions to prevent them.

Disposal and Recycling

Guidelines for the proper disposal and recycling of the medical device.

System Label

Information regarding the system identification label affixed on the console.

Contact Information

Provides contact details for inquiries and support.

Installation

General

Specifies that system installation must be performed by a qualified technician.

Electrical Requirements

Details the necessary mains power supply specifications for system connection.

Environmental Requirements

Outlines conditions for optimal operation, including temperature and humidity.

Receiving the Shipment

Instructions for inspecting the system upon delivery.

Unpacking the System

Step-by-step guide for safely unpacking the NeoGraft system.

Equipment List

Lists all main items and accessories included in the system package.

Installing the Articulated Arm

Procedure for attaching the articulated arm to the system console.

Installing the Handpiece Tray

Steps to mount the handpiece tray onto the articulated arm.

Installing the Handpiece Holders

Instructions for inserting handpiece holders into the handpiece tray.

Installing the Cup Holder

Guide for attaching the cup holder to the handpiece tray.

Installing the Cup

Procedure for placing the cup into the cup holder.

Installing the Footswitches

Instructions for connecting the left and right footswitches to the system.

Installing the Waste Jar

Steps for assembling and placing the waste jar on the system.

Installing the Filter

Guide for connecting the filter assembly to the system and waste jar.

Installing the Extraction Handpiece

Procedure for connecting the extraction handpiece to the system.

Installing the Incision Handpiece

Steps for connecting the incision handpiece to the system.

Installing the Implantation Handpiece

Procedure for assembling and connecting the implantation handpiece.

Connecting the System to the Mains Power

Instructions for connecting the system to an electrical power supply.

System Description

General Description

Overview of the NeoGraft 2.0 system as a hair transplantation device.

System Components

Identifies and illustrates the main external components of the NeoGraft 2.0 system.

System Console

Description of the system console as the main enclosure for system components.

Touch Screen

Details the touch screen's role as the primary user interface and communication tool.

Waste Jar

Description of the waste jar as the container for collected particles and fluids.

Filter

Explains the filter's function in preventing waste penetration into the system.

Handpiece Tray

Details the handpiece tray's installation and function for convenient positioning.

Footswitches

Describes the two footswitches and their pedal functions for system control.

Electrovalves

Explains the function of electrovalves in controlling air flow via footswitches.

Power Switch

Locates and describes the function of the system's power switch.

Extraction Handpiece

Details the components and process of the extraction handpiece.

Incision Handpiece

Explains the function and use of the incision handpiece for creating recipient slits.

Implantation Handpiece

Describes the implantation handpiece's pneumatic system and graft insertion process.

Operating Instructions

Turning the System On;Off

Procedures for powering the NeoGraft 2.0 system on and off.

Selecting the User Account

Steps for selecting a user account from the login screen.

Logging In;Out

Instructions for logging into and out of the system with user credentials.

Setting the Patient Profile

Guide to entering patient details like number, gender, area, and age group.

Donor Site

Details the Donor Site treatment screen elements and controls.

Recipient Site

Details the Recipient Site treatment screen elements and controls.

Operating in the Extraction Phase

Instructions for performing graft extraction using the system.

Operating in the Incision Phase

Procedure for making recipient site slits using the incision handpiece.

Operating in the Implantation Phase

Guide to calibrating the implanter head and performing graft implantation.

Returning to the Patient Profile Screen

Steps to return to the patient profile screen from the treatment screen.

Ending the Treatment

Procedure for concluding the treatment session and finalizing the process.

Advanced Features and Settings

Settings Screen

Overview of features available in the Settings screen for personalization.

Managing User Accounts

Procedures for adding, renaming, enabling/disabling, and removing user accounts.

Extending the Activation Period

Guide to extending system activation time via an activation code.

Activating the Purchased Grafts

Instructions for activating purchased grafts using a 16-digit code.

Setting the Interface Language

Procedure for selecting the preferred language for the system interface.

Technician Mode

Information on accessing the password-protected technician mode.

Displaying the System Information

Instructions to access and view system software and hardware information.

Care and Maintenance

Cleaning the System

Guidelines for cleaning the system's external parts, avoiding harsh detergents.

Cleaning the Waste Jar Components

Detailed steps for cleaning the waste jar and its components.

Cleaning the Extraction Handpiece

Procedures for disconnecting and cleaning the extraction handpiece components.

Cleaning the Incision Handpiece

Instructions for disconnecting and cleaning the incision handpiece body and blade holder.

Cleaning the Implantation Handpiece Components

Steps for disconnecting and cleaning the implantation handpiece components.

Cleaning the Cup

Procedure for cleaning the cup using an ultrasonic bath.

Sterilizing the System Components

Guidelines for steam sterilization of various system components.

Replacing the Filter

Instructions on when and how to replace the hydrophobic filter.

Replacing the Extraction Handpiece Contra-Angle Head Nozzle

Procedure for replacing the nozzle on the extraction handpiece contra-angle head.

Replacing the Implantation Handpiece Head Yellow-Ring;Seal

Guide for replacing the yellow ring and/or seal on the implantation handpiece head.

Troubleshooting

General

Introduction to troubleshooting, suggesting contact with service representative if issues persist.

System Problems

Table detailing common system problems, their possible causes, and solutions.

Specifications

System Specifications

Technical specifications including dimensions, weight, electrical requirements, and operating conditions.

List of approved accessories

Table listing approved accessories with their designation, reference, manufacturer, and EC mark.

Clinical Guide

Introduction

Overview of the NeoGraft 2.0 system for hair transplantation.

Indications

Specifies the system's use as a surgical instrument for hair transplantation.

Contraindications

Lists conditions and factors that contraindicate the use of the NeoGraft system.

Warnings

Highlights critical safety warnings for physicians performing the procedure.

Precautions

Advises caution when treating patients with specific systemic disorders or conditions.

Complications and Side Effects

Describes potential side effects and complications associated with the procedure.

Patient Consultation

Emphasizes the importance of patient consultation prior to surgery.

Treatment Procedure

Details the steps involved in preparing the donor site and the overall treatment process.

Extraction Handpiece

Explains the technique for using the extraction handpiece to harvest grafts.

Incision Handpiece

Describes the technique for using the incision handpiece to create recipient slits.

Implantation Handpiece

Explains the technique for loading and ejecting grafts using the implantation handpiece.

Cleaning and Sterilization

Refers to Chapter 7 for procedures on cleaning and sterilizing system components.

Post-Treatment Procedure

Provides recommendations for aftercare following hair transplantation.

Manufacturer Warranty

Manufacturer Warranty

Outlines the conditions and terms of the device warranty provided by the distributor.

Warranty Certificate

Form to acknowledge receipt and understanding of warranty and usage terms.

VENUS CONCEPT NeoGraft 2.0 Specifications

General IconGeneral
BrandVENUS CONCEPT
ModelNeoGraft 2.0
CategoryMedical Equipment
LanguageEnglish