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Summary of Contents for NeoGraft 2.0

Page 1: ...NeoGraft 2 0 User Manual Document part number MED011XN101 C0 September 2021...

Page 2: ...NeoGraft 2 0 User Manual Document part number MED011XN101 C0 September 2021 Copyright 2021 Venus Concept USA Inc All rights reserved...

Page 3: ...NeoGraft 2 0 User Manual 1 1 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...

Page 4: ...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 u...

Page 5: ...n 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 it...

Page 6: ...ards and shows the system s identification label Chapter 3 Installation Provides information regarding the system installation and its electrical and environmental requirements equipment list electric...

Page 7: ...ides 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...

Page 8: ...on 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 re...

Page 9: ...e 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 a...

Page 10: ...t 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 o...

Page 11: ...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 Conformit Europ ene...

Page 12: ...e 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 mo...

Page 13: ...ion 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 Sa...

Page 14: ...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...

Page 15: ...chnical 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 dermatolog...

Page 16: ...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 accessorie...

Page 17: ...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 cont...

Page 18: ...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 tre...

Page 19: ...verload 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 cor...

Page 20: ...t 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 electrica...

Page 21: ...st of the key steps in cleaning sterilization procedure as described in this manual The equipment is to be stored in clean areas that are protected from contamination vermin and excessive handling The...

Page 22: ...es a safety hazard Perform maintenance procedures only when the system is shut down and disconnected from the mains power Move the system slowly and carefully The system is heavy and may cause injury...

Page 23: ...sence of explosive or flammable materials If germicide wipes are used for cleaning and disinfecting the system it must be allowed to fully dry before the system can be used again 2 8 Disposal and Recy...

Page 24: ...stem Label Figure 2 1 shows the system identification label that is affixed on the system console Figure 2 1 System Identification Label Note Any labels shown in this User Manual are provided for pres...

Page 25: ...13 2 10 Contact Information All inquiries Venus Concept USA Inc 1880 N Commerce Pkwy Ste 2 Weston FL 33326 USA Tel 1 888 907 0115 Fax 1 855 907 0115 Email info venusconcept com Manufacturer Electroniq...

Page 26: ...Safety and Regulatory Information 2 14 NeoGraft 2 0 User Manual...

Page 27: ...ng the Articulated Arm 3 9 3 8 Installing the Handpiece Tray 3 12 3 9 Installing the Handpiece Holders 3 16 3 10 Installing the Cup Holder 3 18 3 11 Installing the Cup 3 21 3 12 Installing the Footswi...

Page 28: ...mains power supply with the following output Single phase 100 240 VAC 50 60 Hz 100 VA As long as the electrical outlet meets the above requirements the system automatically adjusts itself to the local...

Page 29: ...em should be placed in a room with an ambient temperature of 15 25 C 59 77 F and a relative humidity of 30 60 Store the device in a dry and clean room Do not store the system in outdoor conditions Cle...

Page 30: ...isture direct sunlight and damage to ensure they remain sterile Sterile products should be considered unsterile if their packaging loses its integrity Their batch number and expiration date should be...

Page 31: ...with the NIMP15 standard A truck with tailgate is required for its transportation The weight of the packaged device is 88 kg The size of the wooden box is 73 76 138 cm L W H The weight of the unpacke...

Page 32: ...connecting screws It is recommended to use a power screwdriver for this purpose 2 Open the front cover as shown in Figure 3 2 Figure 3 2 Opening the Front Cover of the Shipping Box Warning Device sho...

Page 33: ...t to the device as shown in Figure 3 3 Figure 3 3 Removing the Protective Cardboard 4 Remove all accessories and documents from the box 5 Remove the protective foams from the system 6 Release the syst...

Page 34: ...uded in the shipping box Upon unpacking the system verify that you have received all items that are on the packing list The system includes the following main items System console Articulated arm Hand...

Page 35: ...NeoGraft 2 0 User Manual 3 9 Installation 3 7 Installing the Articulated Arm Figure 3 4 shows the articulated arm which should be installed on the system Figure 3 4 Articulated Arm...

Page 36: ...ft 2 0 User Manual Installation To install the articulated arm 1 Position the articulated arm over its pivot on the system console as shown in Figure 3 5 Figure 3 5 Positioning the Articulated Arm on...

Page 37: ...Insert the articulated arm s base onto its pivot as shown in Figure 3 6 Figure 3 6 Inserting the Articulated arm onto its Pivot 3 Verify that the articulated arm is properly installed as shown in Fig...

Page 38: ...ows the handpiece tray which should be installed on the articulated arm Figure 3 8 Handpiece Tray To install the handpiece tray 1 Align the handpiece tray with its base on the articulated arm as shown...

Page 39: ...to its base and push it all the way as shown in Figure 3 9 Figure 3 10 Inserting the Handpiece Tray onto its Base 3 Verify that the handpiece tray is mounted properly on its base on the articulated ar...

Page 40: ...3 14 NeoGraft 2 0 User Manual Installation 4 From the bottom of the handpiece tray tighten its thumb screw as shown in Figure 3 12 Figure 3 12 Tightening the Handpiece Tray s Thumb Screw...

Page 41: ...NeoGraft 2 0 User Manual 3 15 Installation 5 Verify that the handpiece tray is properly installed on the articulated arm as shown in Figure 3 13 Figure 3 13 Handpiece Tray Installed...

Page 42: ...nstall the handpiece holders 1 Insert the lower handpiece holder into the lower slot on the hanpiece tray as shown in Figure 3 14 Figure 3 14 Inserting the Lower Handpiece Holder 2 Push the handpiece...

Page 43: ...upper slot on the hanpiece tray as shown in Figure 3 16 Figure 3 16 Inserting the Upper Handpiece Holder 4 Push the handpiece holder in as shown in Figure 3 17 Figure 3 17 Pushing the Upper Handpiece...

Page 44: ...the handpiece tray as desired For the purpose of illustration the figures in this guide show the installation of the cup holder on the left side To install the cup holder 1 From the bottom of the hand...

Page 45: ...push in the cup holder into its slot on the handpiece holder as shown in Figure 3 19 Figure 3 19 Inserting the Cup Holder into its Slot 3 Tighten the handpiece holder s thumb screw as shown in Figure...

Page 46: ...User Manual Installation To remove the cup holder 1 From the bottom of the handpiece tray release but do not remove the cup holder s thumb screw as shown in Figure 3 18 2 Pull the cup holder out of t...

Page 47: ...cup 1 Insert and push in the cup into the cup holder as shown in Figure 3 21 Figure 3 21 Inserting the Cup into the Cup Holder 2 Verify that the cup sits firmly on the cup holder as shown in Figure 3...

Page 48: ...Installing the Footswitches 3 12 1 Connecting the Left Footswitch To connect the left footswitch 1 Place the footswitch on the floor next to the system s left side as shown in Figure 3 23 Figure 3 23...

Page 49: ...system s rear side as shown in Figure 3 24 Figure 3 24 Aligning the Pins of the Footswitch s Connector with its Receptacle s Corresponding Holes 3 Connect the footswitch connector to its receptacle by...

Page 50: ...le that is located on the right side of the system s rear side as shown in Figure 3 26 4 Verify that the footswitch is properly connected to the system as shown in Figure 3 26 Figure 3 26 Left Footswi...

Page 51: ...allation 3 12 2 Connecting the Right Footswitch To connect the right footswitch 1 Place the footswitch on the floor next to the system s right side as shown in Figure 3 27 Figure 3 27 Right Footswitch...

Page 52: ...ystem s rear side as shown in Figure 3 28 Figure 3 28 Aligning the Pins of the Footswitch s Connector with its Receptacle s Corresponding Holes 3 Connect the footswitch connector to its receptacle by...

Page 53: ...n the left side of the system s rear side as shown in Figure 3 30 4 Verify that the footswitch is properly connected to the system as shown in Figure 3 30 Figure 3 30 Right and left Footswitch Cables...

Page 54: ...the waste jar 1 Mount the rubber gasket on the jar s black stopper as shown in Figure 3 31 Figure 3 31 Installing the Rubber Gasket on the Stopper 2 Verify that the gasket is properly mounted on the...

Page 55: ...Installation 3 Insert the stopper into the neck of the jar as shown in Figure 3 33 Figure 3 33 Inserting the Stopper into the Jar s Neck 4 Close and tighten the jar s lid as shown in Figure 3 34 Figu...

Page 56: ...the jar is properly assembled and the lid is tightly closed as shown in Figure 3 35 Figure 3 35 Waste Jar Assembled 6 Place the jar in its housing on the system s front side as shown in Figure 3 36 F...

Page 57: ...tle the waste jar 1 Remove the waste jar from the system 2 Unscrew and remove the jar s lid 3 Remove the black stopper from the jar 4 Remove the rubber gasket from the black stopper Warning Contents o...

Page 58: ...l the filter 1 Remove the filter s caps as shown in Figure 3 37 Figure 3 37 Removing the Filter s Caps 2 Connect the longer piece of the vacuum tube to its quick connector fitting as shown in Figure 3...

Page 59: ...filter s Inlet port as shown in Figure 3 39 Figure 3 39 Connecting the Long Tube and Fitting to the Filter s Inlet Port 4 Connect the shorter piece of the vacuum tube to the filter s Outlet port as s...

Page 60: ...the system s front side as shown in Figure 3 41 Figure 3 41 Connecting the Filter Assembly to the System s Vacuum Connector 6 Connect the other end of the filter assembly to the shorter pipe of the wa...

Page 61: ...Installation Figure 3 43 Vacuum Filter Tube to be Connected to the Stopper s Shorter Pipe 7 Verify that the filter is properly installed as shown in Figure 3 44 Figure 3 44 Filter Assembly Installed...

Page 62: ...NeoGraft 2 0 User Manual Installation To remove the filter 1 Verify that the system is turned off or placed in the Standby state 2 Disconnect the two tubes from the filter 3 Remove and discard the fi...

Page 63: ...n Chapter 7 before installing using them Note The single use tubing is supplied sterile After each treatment the tubing must be discarded as hazardous medical waste Warning The single use punches are...

Page 64: ...piece 1 Align the red mark of the Extraction Handpiece Cable Connector with the red mark of the corresponding receptacle on the system s rear side as shown in Figure 3 45 Figure 3 45 Aligning the Red...

Page 65: ...ush the connector into the receptacle as shown in Figure 3 46 Figure 3 46 Connecting the Handpiece Cable Connector 3 Verify that the connector is pushed all the way into the receptacle as shown in Fig...

Page 66: ...dpiece cable connector as shown in Figure 3 48 Figure 3 48 Aligning the Connectors of the Handpiece Cable amd the Handpiece Motor 5 Connect the handpiece motor to the handpiece cable connector by push...

Page 67: ...ead to the motor by pushing the head onto the motor as shown in Figure 3 50 Figure 3 50 Pushing the Contra Angle Head onto the Motor 7 Align the handpiece punch with the hole on the contra angle head...

Page 68: ...he handpiece while pushing the contra angle head s button as shown in Figure 3 52 Figure 3 52 Pushing the Punch into the Handpiece while Pushing the Contra Angle Head s Button 9 Verify that the punch...

Page 69: ...43 Installation 10 Assemble the graft collector as shown in Figure 3 54 Figure 3 54 Assembling the Graft Collector 11 Attach the clamp to the handpiece as shown in Figure 3 55 Figure 3 55 Attaching t...

Page 70: ...with its Graft Side Facing the Handpiece Head as shown in Figure 3 56 Figure 3 56 Attaching the Graft Collector to the Handpiece Clamp 13 Connect the Sterile graft tube to the graft collector s Graft...

Page 71: ...e on the contra angle head s button as shown in Figure 3 58 Figure 3 58 Connecting the Graft Tube to the Handpiece 15 Connect the Sterile extraction tube to the graft collector s Suction side as shown...

Page 72: ...xtraction handpiece on the handpiece holder as shown in Figure 3 60 Figure 3 60 Placing the Extraction Handpiece on the Handpiece Holder 17 Connect the extraction tube to the jar as shown in Figure 3...

Page 73: ...of the jar is not to be used cover it with a silicon cap as shown in Figure 3 62 Figure 3 62 Silicon Cap Connected to the Waste Jar s Unused Inlet Pipe Caution In order to avoid leakage always make su...

Page 74: ...own in Figure 3 63 Figure 3 63 Positioning the Extraction Tube s Thick Inset Next to the Left Electrovalve 20 Push and hold the electrovalve while inserting the extraction tube s thick inset inti the...

Page 75: ...its slot as shown in Figure 3 65 Figure 3 65 Extraction Tube Inserted into the Left Electrovalve 22 Insert the handpiece s cable and tubing into the cable tube holders on the articulated arm as shown...

Page 76: ...be holders to secure the cable and tubing loosely within them Note For proper system operation each of the air outlets on the system s rear side must be covered either by a properly installed implanta...

Page 77: ...tube out of its slot 6 Disconnect the tubes from the handpiece and from the system 7 Discard the used tubing as hazardous medical waste 8 Disconnect the clamp from the handpiece 9 Remove the punch by...

Page 78: ...dpiece components are properly cleaned and sterilized as described in Chapter 7 before installing using them Warning The single use incision blades are supplied sterile Each blade must be discarded in...

Page 79: ...mark of the cable connector with the white mark of the receptacle as shown in Figure 3 67 Figure 3 67 Connecting the Incision Handpiece to the System While Aligning the White mark of the Handpiece Ca...

Page 80: ...ision blade into the blade holder s slot as shown in Figure 3 69 Figure 3 69 Inserting the Incision Blade into the Blade Holder s Slot 4 Carefully push the blade well into the blade holder as shown in...

Page 81: ...ade holder into the handpiece base as shown in Figure 3 71 Figure 3 71 Inserting the Blade Holder into the Handpiece Base 6 Insert the handpiece body onto the blade holder as shown in Figure 3 72 Figu...

Page 82: ...crew the handpiece body to the handpiece base as shown in Figure 3 73 Figure 3 73 Screwing the Handpiece Body to the Handpiece Base 8 Verify that the handpiece is properly assembled as shown in Figure...

Page 83: ...handpiece to adjust the length of the incision blade as shown in Figure 3 75 Figure 3 75 Adjusting the Length of the Incision Blade 10 Place the incision handpiece on the handpiece holder as shown in...

Page 84: ...s cable into the cable tube holders on the articulated arm as shown in Figure 3 77 Figure 3 77 Incision Handpiece Cable Inserted into the Articulated Arm s Cable Tube Holders 12 Fasten but do not tigh...

Page 85: ...remove the blade from the blade holder 4 Discard the blade in a hazardous sharps disposal container 5 Remove the handpiece cable from the cable tube holders on the articulated arm 6 Disconnect the han...

Page 86: ...on Handpiece Note Make sure that all handpiece components are properly cleaned and sterilized as described in Chapter 7 before installing using them Note The single use tubing is supplied sterile Afte...

Page 87: ...3 78 Inserting the Handpiece Piston into the Implanter Head 2 Verify that the tip of the piston is aligned with the implanter head s suction port as shown in Figure 3 81 3 Connect the implanter head...

Page 88: ...ewing the Head to the Handpiece Body 5 Use the adjusting screw of the handpiece to set the implanter head s piston tip at the correct position as shown in Figure 3 81 Figure 3 81 Correct Positioning o...

Page 89: ...are sucked into the implanter head to be inserted in the recipient site During this stage it is important to have the implanter head s piston tip at the correct position i e aligned with the implante...

Page 90: ...suction port of the implanter head as shown in Figure 3 83 Figure 3 83 Connecting the Distal End of the Implantation Tubing to the Implanter Head 8 Place the implantation handpiece on the handpiece ho...

Page 91: ...t 10 Proceed as follows If two implantation handpieces are to be used simultaneously connect the Luer lock end of the implantation tube of the second handpiece to the system s air outlet port 2 on the...

Page 92: ...oceed as follows If two implantation handpieces are to be used simultaneously connect the proximal end of the implantation tube of the second handpiece to the other inlet pipe of the waste jar If only...

Page 93: ...in Figure 3 88 Figure 3 88 Positioning the Implantation Tube s Thick Inset Next to the Right Electrovalve 14 Push and hold the electrovalve while inserting the implantation tube s thick inset inti th...

Page 94: ...pieces are to be used simultaneously repeat the above steps to insert the implantation tube of the second handpiece into the system s left electrovalve 17 Insert the handpiece s tubing into the cable...

Page 95: ...ube from the electrovalve by pushing the electrovalve and pulling the tube out of its slot 3 Disconnect the tubes from the handpiece waste jar and the system 4 Discard the used tubing as hazardous med...

Page 96: ...hown in Figure 3 92 Figure 3 92 Power Connection Port on the System s Rear Side 2 Plug the other end of the power cable to the mains power supply Caution Before connecting the system to the power outl...

Page 97: ...Page 4 1 System Components 4 2 4 2 System Console 4 5 4 3 Touch Screen 4 5 4 4 Waste Jar 4 6 4 5 Filter 4 6 4 6 Handpiece Tray 4 7 4 7 Footswitches 4 8 4 8 Electrovalves 4 9 4 9 Power Switch 4 10 4 10...

Page 98: ...eparate handpieces for extracting the grafts performing the recipient site incisions and implanting the grafts 4 2 System Components The following figures show the main components of the NeoGraft 2 0...

Page 99: ...System Description NeoGraft 2 0 User Manual 4 73 Figure 4 1 System Components Front Vacuum Connection Port Filter Waste Jar Jar Housing Figure 4 2 System Components Waste Jar...

Page 100: ...rimary Implantation Handpiece Power Switch Air Outlet Port 2 for Secondary Implantation Handpiece Extraction Handpiece Cable Connection Port Figure 4 3 System Components Upper Rear Right Power Connect...

Page 101: ...tem components 4 4 Touch Screen The touch screen as shown in Figure 4 1 is the primary means of communication between the user and the system The on screen graphical user interface keeps the user info...

Page 102: ...r as shown in Figure 4 2 prevents the penetration of any waste particles or fluids from the waste jar into the system Warning Contents of the waste jar must be discarded as biohazard waste Caution Be...

Page 103: ...cision Handpiece Handpiece Implantation Tray Cup Holder Cup Figure 4 5 Handpiece Tray Components Handpiece Extraction Handpiece Handpiece Holders The handpiece holders mounted on the handpiece tray ho...

Page 104: ...xtract mode is On The white pedal is not in use and pressing it has no effect On the right footswitch The blue pedal activates the vacuum on the implantation handpiece when the Implant mode is On The...

Page 105: ...s two left and right electrovalves which are mounted on the top of the system console Left Electrovalve Articulated Arm Base Right Electrovalve Figure 4 7 Electrovalves Electrovalves are footswitch o...

Page 106: ...0 User Manual System Description 4 10 Power Switch Figure 4 8 shows the power switch which is located on the system s rear side as shown in Figure 4 3 Figure 4 8 Power Switch The power switch turns th...

Page 107: ...ng punch The punch penetrates the tissue until the arrector muscle The vacuum sucks the graft into the graft collector that is attached to the handpiece In order to guide the penetration of the punch...

Page 108: ...sion which is carried out with a blade or a needle The handpiece is connected to the system via its cable and using its sensor counts the number of incisions which is displayed on the screen Different...

Page 109: ...he piston that is placed inside the head of the implanter and screwed to the handpiece During the implantation phase the previously extracted grafts can be placed on a sterile glove or gauze pad as sh...

Page 110: ...ser Manual System Description Two implantation handpieces are supplied with the system enabling two operators to perform the implantation at the same time 0 8 mm 0 9mm and 1 0 mm implanters are suppli...

Page 111: ...5 2 Selecting the User Account 5 4 5 3 Logging In Out 5 5 5 4 Setting the Patient Profile 5 8 5 5 Treatment Screens 5 10 5 6 Operating in the Extraction Phase 5 14 5 7 Operating in the Incision Phase...

Page 112: ...ries are properly installed on the system as described in Chapter 3 2 Verify that the power cable is connected to the power connection port on the rear side of the system console and is plugged into t...

Page 113: ...tion screen as shown in Figure 5 2 Figure 5 2 Login Account Selection Screen Note The Remaining Grafts indicator appears only in systems with the Graft Purchasing configuration To turn off the system...

Page 114: ...elect the user account 1 Verify that the system is turned on and the Account Selection screen appears as shown in Figure 5 2 2 From the Login Account Selection screen press the desired user account th...

Page 115: ...authorized users may result in patient injury To log in 1 Verify that the Login screen appears as shown in Figure 5 3 Note To return to the Account Selection screen without entering the password press...

Page 116: ...enter an incorrect password the following message appears Invalid password Please try again If you enter the incorrect password five times the system disables your user account and displays the follow...

Page 117: ...ent Profile screen appears as shown in Figure 5 4 2 Press the Logout button the Log Out screen appears as shown in Figure 5 5 Figure 5 5 Log Out Screen 3 Press the Log Out button The system logs out o...

Page 118: ...file 1 Verify that the Patient Profile screen appears as shown in Figure 5 4 2 In the Patient Profile screen enter the patient number as follows i Tap inside the Patient No field box a numeric keyboar...

Page 119: ...Operating Instructions NeoGraft 2 0 User Manual 5 9 3 Press the Confirm button the Donor Site Treatment screen appears as shown in Figure 5 6 Figure 5 6 Donor Site Treatment Screen...

Page 120: ...nts of the Donor Site treatment screen as indicated by numbers in Figure 5 7 are described below 1 Back button Allows you to return to the previous Patient Profile screen Upon pressing the Back button...

Page 121: ...reset the counter by pressing the Reset Counter button 6 Extract Implant Selector Toggles between the Donor Site and Recipient Site treatment screens Extract and Implant modes respectively 7 Remainin...

Page 122: ...the Recipient Site treatment screen as indicated by numbers in Figure 5 8 are described below 1 Back button Allows you to return to the previous Patient Profile screen Upon pressing the Back button a...

Page 123: ...counter by pressing the Reset Counter button 6 Extract Implant Selector Toggles between the Donor Site and Recipient Site treatment screens Extract and Implant modes respectively 7 Remaining Grafts in...

Page 124: ...User Manual 5 6 Operating in the Extraction Phase To operate in the Extraction phase refer to section 5 5 1 1 Verify that the Donor Site Treatment screen appears as shown in Figure 5 9 Figure 5 9 Don...

Page 125: ...Figure 5 10 Figure 5 10 Donor Site Treatment Screen in Start State 3 Adjust the motor speed as follows i In the Motor Speed controller swipe the wheel or Press the Up Down arrow buttons to set the des...

Page 126: ...Graft Counter increments the indicated number by one 6 Release the footswitch pedal the handpiece motor stops operating 7 Repeat the above steps to extract additional grafts as desired 5 7 Operating i...

Page 127: ...annot be moved by turning the handpiece s adjusting screw Calibrating the implanter head places the implanter head s piston tip at the correct position as shown in Figure 5 11 Correct Piston Tip Posit...

Page 128: ...graft into the handpiece If piston tip is shifted inwards the graft may be sucked too strongly causing it to overshoot towards the waste jar To calibrate the implanter head 1 From the Treatment screen...

Page 129: ...t the distal end of the implantation tube to the suction port of the implanter head 5 8 2 Performing the Implantation To perform the implantation refer to section 5 5 2 1 Verify that the Recipient Sit...

Page 130: ...st the implantation pressure as follows i In the Implantation Pressure controller swipe the wheel or Press the Up Down arrow buttons to set the desired implantation pressure value the Set Value button...

Page 131: ...ch pedal 8 Position the implantation handpiece on the previously made slit at the treatment site 9 On the right footswitch press the white pedal to eject the graft into the slit Note If you are using...

Page 132: ...atment screen to the Patient Profile screen resets the currently set patient profile To return from the Treatment screen to the Patient Profile screen 1 From the Treatment screen press the Back button...

Page 133: ...eoGraft 2 0 User Manual 5 23 2 Press the Yes Reset the Patient Profile button The system resets the currently set patient profile The Patient Profile screen appears as shown in Figure 5 15 Figure 5 15...

Page 134: ...atment screen press the End Treatment button the Finalizing Treatment Attention screen appears as shown in Figure 5 16 Figure 5 16 Finalizing Treatment Attention Screen 2 Press the Yes Finish Treatmen...

Page 135: ...er Contents Section Title Page 6 1 Settings screen 6 2 6 2 Managing User Accounts 6 5 6 3 Extending the Activation Period 6 20 6 4 Activating the Purchased Grafts 6 22 6 5 Setting the Interface Langua...

Page 136: ...technicians to update the system software and control various settings Table 6 1 Settings Screen Features Icon Description See Section Accounts Allows the system administrator to add remove users ena...

Page 137: ...n Features cont Icon Description See Section Technician Mode Allows qualified Venus Concept technicians to access the Technician mode 6 6 Information Displays information regarding the system software...

Page 138: ...Advanced Features and Settings 6 4 NeoGraft 2 0 User Manual To access the Settings screen From the Patient Profile or Treatment screen press the Settings button the Settings screen appears...

Page 139: ...on page 6 7 Renaming a User see section 6 2 3 on page 6 11 Changing a User Password see section 6 2 5 on page 6 15 Enabling Disabling a User see section 6 2 4 on page 6 13 Removing a User see section...

Page 140: ...gs 6 6 NeoGraft 2 0 User Manual 3 From the Settings screen press the Accounts icon as shown in Table 6 1 the Accounts screen appears as shown in Figure 6 1 Figure 6 1 Accounts Screen The Accounts scre...

Page 141: ...6 7 6 2 2 Adding a User To add a user 1 Access the Accounts screen as described in section 6 2 1 2 In the Accounts screen tap the New Account button the New Account Step 1 of 3 screen appears as shown...

Page 142: ...p inside the Name box the virtual keyboard appears as shown in Figure 6 3 Figure 6 3 Virtual Keyboard in New Account Step 1 of 3 Screen 4 Type the desired name for the new user account Note The user n...

Page 143: ...onfirm button the New Account Step 2 of 3 screen appears as shown in Figure 6 4 Figure 6 4 New Account Step 2 of 3 Screen 6 Type the desired password login PIN code Note The password must have 4 to 8...

Page 144: ...5 Figure 6 5 New Account Step 3 of 3 Screen 8 Re enter the password login PIN code 9 Press the Confirm button to close the Enter New PIN screen and return to the Accounts screen 10 Verify that the new...

Page 145: ...Renaming a User To rename a user 1 Access the Accounts screen as described in section 6 2 1 2 In the Accounts screen tap the User entry that is to be renamed the selected user s Account screen appear...

Page 146: ...g the virtual keyboard as shown in Figure 6 7 Note The user name must be unique There cannot be two users with the same name 5 Press the Confirm button to close the Rename screen and return to the Acc...

Page 147: ...ounts screen tap the User entry that is to be enabled disabled the selected user s Account screen appears as shown in Figure 6 8 Figure 6 8 Selected User s Account Screen 3 Press the Enable Disable bu...

Page 148: ...Features and Settings 6 14 NeoGraft 2 0 User Manual 4 Press the Confirm button to apply and return to the Accounts screen 5 Press the Back button to close the Accounts screen and return to the Setting...

Page 149: ...er Password To change a user password 1 Access the Accounts screen as described in section 6 2 1 2 In the Accounts screen tap the User entry whose password is to be changed the selected user s Account...

Page 150: ...ange PIN button the Change PIN Step 1 of 2 screen appears as shown in Figure 6 10 Figure 6 10 Change PIN Step 1 of 2 Screen 4 Type the desired password login PIN code Note The password must have 4 to...

Page 151: ...hange PIN button the Change PIN Step 2 of 2 screen appears as shown in Figure 6 11 Figure 6 11 Change PIN Step 2 of 2 Screen 6 Press the Confirm button to apply the change and return to the Accounts s...

Page 152: ...r to remove Users Note The Administrator itself cannot be removed To remove a user 1 Access the Accounts screen as described in section 6 2 1 2 In the Accounts screen tap the User entry that is to be...

Page 153: ...hown in Figure 6 13 Figure 6 13 Delete User Screen 4 Press the Yes Delete User button to apply the deletion and return to the Accounts screen 5 Verify that the deleted user does not appear in the Acco...

Page 154: ...ng it the following message appears Activation period has expired Expiration Date MMM DD YYYY Please enter new Activation Code If the system use is restricted to a limited Operation Time the remaining...

Page 155: ...pears as shown in Figure 6 14 Figure 6 14 Customer Portal Screen 3 Contact your local Venus Concept representative and indicate the Key Number that is displayed on top the screen The representative wi...

Page 156: ...this configuration the use of system is not restricted to the number of purchased grafts Graft Purchasing In this configuration the use of system is restricted to the number of purchased grafts This s...

Page 157: ...s the Settings screen as described in section 6 1 3 From the Settings screen press the Activate icon as shown in Table 6 1 the Customer Portal screen appears as shown in Figure 6 15 Figure 6 15 Custom...

Page 158: ...s the Settings screen as described in section 6 1 2 From the Settings screen press the Language icon as shown in Table 6 1 the Language screen appears as shown in Figure 6 16 Figure 6 16 Language Scre...

Page 159: ...6 Technician Mode This feature is password protected and is to be used only by qualified Venus Concept technicians Warning Attempting to bypass the password protection and to access the Technician mod...

Page 160: ...ion To display the system information 1 Access the Settings screen as described in section 6 1 2 From the Settings screen press the Information icon as shown in Table 6 1 the Information screen appear...

Page 161: ...leaning the Extraction Handpiece 7 4 7 4 Cleaning the Incision Handpiece 7 13 7 5 Cleaning the Implantation Handpiece Components 7 16 7 6 Cleaning the Cup 7 19 7 7 Sterilizing the System Components 7...

Page 162: ...rgents such as ammonia acetone hydrochloric acid chlorine bleach and other fluids that can damage or destroy plastic or metal components 7 2 Cleaning the Waste Jar Components To clean the waste jar an...

Page 163: ...for a minimum of 20 seconds Use a bottle brush to brush inside the glass jar Use an interdental brush to brush inside the cylindrical parts of the black stopper Use a toothbrush to brush inside and o...

Page 164: ...Remove the handpiece from the system 2 Disconnect all tubes from the handpiece and discard them Warning Used tubes must be discarded as biohazard waste 3 Disconnect the graft collector from the handpi...

Page 165: ...tal brush for a minimum of 20 seconds Make sure to brush inside and outside the container its lid both sides of the filter and the stainless steel rod screw hole 4 Graft collector only Using a syringe...

Page 166: ...inge filled with 3 ml of ANIOS CLEAN EXCEL D detergent solution at room temperature 15 C 25 C flush the inside of the stainless steel rod joins on the lid and inside the container and the stainless st...

Page 167: ...ng a syringe filled with 3 ml of ANIOS CLEAN EXCEL D detergent solution at room temperature 15 C 25 C Flush each part with 3 ml of the solution 5 Rinse each part with Water WFI Water For Injection for...

Page 168: ...y are clean intact and in good condition Any soiled part must be re cleaned Any damaged e g broken twisted rusty part should be discarded 13 Lubricate the contra angle head with the Lubrifluid Caution...

Page 169: ...xterior and interior of the motor with running water 38 C for 10 seconds 3 Disinfect the external surface of the motor using a soft bristle brush soaked with a suitable detergent or disinfectant solut...

Page 170: ...detergent Select the specified washing cycle for the instrument which should be compatible with the detergent manufacturer s instructions Use the following recommended temperatures Pre wash Water cold...

Page 171: ...cleaning disinfection of dental or surgical instruments Quaternary ammonium and or enzyme based surfactants Caution Do not use solutions that are corrosive or contain chlorine acetone aldehydes or ble...

Page 172: ...th 3 ml of ANIOS CLEAN EXCEL D detergent solution flush inside the punch 4 Rinse the punch with lukewarm 25 C 35 C 77 F 95 F Water WFI Water For Injection for a minimum of 10 seconds 5 Once again soak...

Page 173: ...7 4 2 Cleaning the Incision Handpiece Body and Blade Holder To clean the incision handpiece body and blade holder 1 Soak the components of in an ultrasonic bath filled with ANIOS CLEAN EXCEL D 0 5 en...

Page 174: ...te 6 Remove the components from the ultrasonic bath and clean each component with an appropriate brush e g toothbrush or interdental brush for a minimum of 20 seconds Make sure to brush inside and out...

Page 175: ...able solutions include Detergent or detergent disinfectant pH 6 9 5 recommended for cleaning disinfection of dental or surgical instruments Quaternary ammonium and or enzyme based surfactants Caution...

Page 176: ...emove the handpiece from the system 2 Disconnect the tubes from the handpiece and discard them Warning Used tubes must be discarded as biohazard waste 3 Unscrew and disconnect the handpiece head from...

Page 177: ...ds Make sure to brush inside and outside of the components 4 Slide the piston inside the head and perform 3 back and forth movements to remove residues from the lumen 5 Using a syringe filled with 3 m...

Page 178: ...sing a syringe filled with 3 ml of ANIOS CLEAN EXCEL D detergent solution at room temperature 15 C 25 C flush the inside of the stainless steel rod joins on the lid and inside the container and the st...

Page 179: ...priate brush e g a toothbrush for a minimum of 20 seconds 4 Rinse the cup with Water WFI Water For Injection for a minimum of 10 seconds 5 Once again soak the cup in an ultrasonic bath filled with ANI...

Page 180: ...the waste jar All components of the extraction handpiece All components of the implantation handpiece All components of the incision handpiece except for the handpiece cable Caution Do not sterilize t...

Page 181: ...s of the components Make sure to perfectly clean each item befor performing the sterilization To sterilize each component 1 Pack each item in a pouch suitable for steam sterilization 2 Perform autocla...

Page 182: ...placed it becomes wet and its color changes to gray To replace the filter 1 Turn off the system or place it in the Standby state 2 Disconnect the filter s vacuum tube from the system 3 Disconnect the...

Page 183: ...head Figure 7 1 Contra Angle Head Nozzle Caution The screwdriver provided for performing the nozzle replacement is not sterile and cannot be sterilized Make sure to clean lubricate and sterilize the...

Page 184: ...objects 5 Insert the new nozzle into the hole at the tip of the contra angle head 6 Hold the vacuum part at the tip of the contra angle head with your fingers to stop it from turning while screwing t...

Page 185: ...or wear out the seal by enlarging the seal s internal diameter hindering the piston s free movement To prevent any infiltration of the liquid inside the tubing connected to the compressor always make...

Page 186: ...al i Remove the old seal ii Insert the new seal into its groove in the handpiece head If replacing the yellow ring discard the old ring and use the new one 5 Insert the yellow ring into the head 6 Usi...

Page 187: ...NeoGraft 2 0 User Manual 8 1 Chapter 8 Troubleshooting Chapter Contents Section Title Page 8 1 General 8 2 8 2 System Problems 8 3...

Page 188: ...rovides solutions to some problems that may arise while operating the system Section 8 2 Table 8 1 provides solutions to various system problems If you are not able to solve the problem using the prov...

Page 189: ...k the fuses on the back of the unit Low or no vacuum Displayed Vacuum is OK but there is no vacuum in handpiece Air leakage Water infiltrated the hydrophobic filter Handpiece not working properly Chec...

Page 190: ...Bad tubing connection Improper implantation handpiece head piston position Incorrect implanter size Check all connections Adjust the piston position by turning the handpiece s adjusting screw Adjust...

Page 191: ...Clogged punch or contra angle head Check handpiece connection Replace the punch Clean or replace the contra Angle head Replace contra angle head nozzle No or low contra Angle motor rotation Improper h...

Page 192: ...8 6 NeoGraft 2 0 User Manual Troubleshooting...

Page 193: ...NeoGraft 2 0 User Manual 9 1 Chapter 9 Specifications Chapter Contents Section Title Page 9 1 System Specifications 9 2 9 2 List of approved accessories 9 4...

Page 194: ...ions Dimensions W D H not packed 45 40 100 cm 17 7 15 8 39 4inch Weight 36 kg 79 4 lbs Color White and gray Electrical requirements 100 240 VAC 50 60 Hz Main fuses 2 5 20 T2AH 250 VAC qty 2 Operating...

Page 195: ...ternal pressure 2 5 bars Implantation handpiece pressure 0 to 2 5 bars Contra angle head rotation speed 0 to 3000 rpm Maximum vacuum 800 mbars Device Classification I in U S A II in Canada IIa in euro...

Page 196: ...Reference Manufacturer CE Mark Sterile blade SP90 Swann Morton CE0086 Sterile blade SP91 Swann Morton CE0086 Extractor cleaning spray AquaCare Bien air CE Extractor cleaning spray Spraynet Bien air C...

Page 197: ...ction A 2 A 2 Indications A 3 A 3 Contraindications A 3 A 4 Warnings A 4 A 5 Precautions A 4 A 6 Complications and Side Effects A 5 A 7 Patient Consultation A 5 A 8 Treatment Procedure A 6 A 9 Handpie...

Page 198: ...transplantation system The system uses three separate handpieces for extracting the grafts making incisions at the recipient site and implanting the grafts Figure A 1 shows the three handpieces that...

Page 199: ...ian should determine the patient eligibility for a hair transplantation procedure Device can be used on both male and female patients A 3 Contraindications Any Active condition in the surgical area su...

Page 200: ...afety precautions as described in this Clinical Guide and elsewhere in this User Manual If hair loss stems from genetic factors such sensitivity to DHT or male pattern baldness hair loss may continue...

Page 201: ...typically within two weeks Other minor side effects may include Donor alopecia Follicular cysts Post operative bleeding Shock loss Visible scarring Infection A 7 Patient Consultation The physician sho...

Page 202: ...and Implantation Pressure The extraction handpiece utilizing the system s vacuum which is not adjustable cores and extracts the graft after 3 5 rotations of the punch A starting Motor Speed of 15 has...

Page 203: ...e to use Figure A 2 shows the graft extraction process Figure A 2 Graft Extraction The extraction handpiece punctures the tissue and as the punch rotates it scores the depth of tissue The punch is lim...

Page 204: ...least amount of trauma to the bulb of the graft A 9 Handpiece Placement and Technique A 9 1 Extraction Handpiece Use the extraction handpiece as follows 1 Center the punch over the follicular unit an...

Page 205: ...t site incision based on each individual patient s hair type and density A 9 3 Implantation Handpiece Use the implantation handpiece as follows 1 Load the grafts one at a time from the sterile field i...

Page 206: ...ering which may dislodge the implanted grafts for two weeks post op To minimize hyperpigmentation patients should be asked to avoid excessive sun exposure for two weeks post op Patients should refrain...

Page 207: ...NeoGraft 2 0 User Manual B 1 Appendix B Manufacturer Warranty Chapter Contents Section Title Page B 1 Manufacturer Warranty B 2 B 2 Warranty Certificate B 4...

Page 208: ...Venus Concept or its authorized distributor Conditions and facilities in the operating room meet all relevant legal requirements NeoGraft 2 0 is used only by qualified and trained personnel in accorda...

Page 209: ...ts malfunctions etc The authorized distributor provides warranty and after sales service The warranty covers parts and labor All other services are determined on the basis of the conditions set by the...

Page 210: ...cleaning sterilization etc of the device I bind to use only consumables and accessories supplied by Venus Concept and its authorized distributor I acknowledge having read the User Manual thoroughly a...

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