Table of Contents

Table of Contents..................................................................................................................... a

List of Figures........................................................................................................................... e

Chapter 1. Indications, Precautions & Warnings................................................................ 1

Intended Use.................................................................................................................... 1

Indications for Use..................................................................................................... 1

Contraindications............................................................................................................. 1

Conventions used in this Guide......................................................................................... 2

Special Notations & Symbols Glossary.............................................................................. 3

Laser Safety..................................................................................................................... 4

Installation Precautions..................................................................................................... 4

Computer Precautions....................................................................................................... 5

Application Precautions.................................................................................................... 5

Chapter 2. Laser System Components.................................................................................. 7

Components List.............................................................................................................. 7

Reference Images............................................................................................................. 8

Preparing for Installation................................................................................................ 11

Chapter 3. Hardware Installation........................................................................................ 13

LYKOS Objective Turret Attachment.............................................................................. 13

LYKOS Laser Controller Connections............................................................................. 14

Digital Camera Installation............................................................................................. 15

Orienting the Camera to the Stage Movement............................................................ 16

Computer Connections................................................................................................... 16

Desktop Computer................................................................................................... 16

Laptop Computer..................................................................................................... 17

Chapter 4. Start Up and Software Overview...................................................................... 19

System Start Up............................................................................................................. 19

Software Layout............................................................................................................. 19

Video Window......................................................................................................... 19

Control Panel........................................................................................................... 19

Image & Video Control Panel................................................................................... 20

Main Menu.............................................................................................................. 20

Chapter 5. Setup Screens...................................................................................................... 23

Laser............................................................................................................................. 23

Auto Labels............................................................................................................. 23

Image Capture......................................................................................................... 25

Laser Settings.......................................................................................................... 27

Overlay Settings....................................................................................................... 31

Time Lapse.............................................................................................................. 32

Video Capture.......................................................................................................... 33

Optics............................................................................................................................ 34

Camera Settings....................................................................................................... 34

Objectives............................................................................................................... 35

Chapter 6. Magnification Calibration and RED-i Alignment........................................... 37


Magnification Calibration............................................................................................... 37

RED-i Alignment........................................................................................................... 38

RED-i Target Alignment Procedure........................................................................... 39

Initialize and Verify....................................................................................................... 41

Initialize DTS.......................................................................................................... 41

Verify DTS.............................................................................................................. 41

Chapter 7. Patient & Embryo Information........................................................................ 43

Patient Info.................................................................................................................... 43

Embryo Panel................................................................................................................ 43

Info......................................................................................................................... 43

Measurements.......................................................................................................... 44

Data Fields.............................................................................................................. 46

Chapter 8. Working with Images & Videos........................................................................ 47

Thumbnail Gallery......................................................................................................... 47

Working with Images..................................................................................................... 47

Opening, Saving and Deleting................................................................................... 47

Capturing Images..................................................................................................... 48

Adding Images to Report.......................................................................................... 48

Viewing and Closing Images..................................................................................... 48

Image Toolbox......................................................................................................... 49

Working with Videos..................................................................................................... 51

Opening, Saving and Deleting................................................................................... 51

Capturing Real Time Videos..................................................................................... 51

Capturing Time Lapse Video.................................................................................... 51

Playing Videos......................................................................................................... 52

Chapter 9. Laser Modes and System Operation................................................................ 53

Working in Full Screen View.......................................................................................... 53

Clinical Laser Mode....................................................................................................... 54

Activating the Laser Energy Level............................................................................ 54

Firing the Laser........................................................................................................ 55

Validation Mode............................................................................................................ 55

Configuring Validation Mode................................................................................... 55

Validation Control Panel........................................................................................... 55

Multipulse Mode............................................................................................................ 56

Multipulse Laser Settings......................................................................................... 57

Multipulse Laser Panel............................................................................................. 57

Firing the Laser........................................................................................................ 58

Built-in Maximum Limits for Multipulse Mode.......................................................... 58

Chapter 10. Dynamic Targeting System............................................................................. 59

Introduction................................................................................................................... 59

Path Type................................................................................................................ 60

Initialization and Verification.......................................................................................... 60

Objective Calibration............................................................................................... 60

RED-i Target Alignment to Laser.............................................................................. 60

Initialize and Verify................................................................................................. 60

Using DTS Option......................................................................................................... 61

Clinical Mode.......................................................................................................... 61

Validation Mode...................................................................................................... 62


Working with Path Types......................................................................................... 64

IVQC Report................................................................................................................. 65

IVQC Report Screen Layout..................................................................................... 66

Report Panel............................................................................................................ 66

IVQC Trend Report Toolbar..................................................................................... 67

Save and Print Toolbar............................................................................................. 67

Chapter 11. Reporting & ASCII.......................................................................................... 69

Working with Reports.................................................................................................... 69

Report Template...................................................................................................... 69

Viewing Reports...................................................................................................... 70

Designing Reports.................................................................................................... 70

Report Property Descriptions.......................................................................................... 73

General.................................................................................................................... 73

Working with ASCII Data.............................................................................................. 78

Chapter 12. Laser Applications........................................................................................... 79

Laser-assisted Hatching (LAH)....................................................................................... 79

Laser Positioning..................................................................................................... 79

Laser Zona Drilling Options..................................................................................... 79

Clinical Laser Energy Level...................................................................................... 80

Laser-assisted Blastomere Biopsy................................................................................... 80

Laser-assisted Trophectoderm Biopsy............................................................................. 81

Getting Ready................................................................................................................ 81

RED-i...................................................................................................................... 81

Check Target Alignment........................................................................................... 82

Focusing on the Embryo........................................................................................... 82

Performing Laser-assisted Hatching................................................................................ 82

Fixed Laser: Laser-assisted Hatching Procedure......................................................... 82

Laser-assisted Hatching using DTS........................................................................... 83

Performing Blastomere Biopsy....................................................................................... 84

Fixed Laser: Laser-assisted Blastomere Biopsy Procedure.......................................... 84

Laser-assisted Blastomere Biopsy using DTS............................................................. 84

Performing Trophectoderm Biopsy.................................................................................. 85

Fixed Laser: Using Manual Pulses to Remove Trophectoderm Cells............................ 85

Fixed Laser: Using Multipulse Mode to Remove Trophectoderm Cells........................ 86

Laser-assisted Trophectoderm Biopsy using DTS....................................................... 87

Troubleshooting Failed Drilling Attempts........................................................................ 88

Chapter 13. Help Menu......................................................................................................... 89

About............................................................................................................................ 89

Database........................................................................................................................ 89

Backup.................................................................................................................... 89

Restore.................................................................................................................... 89

Optimize................................................................................................................. 89

Save Support Package.................................................................................................... 90

Appendix A. Laser System Specifications........................................................................... 91

Operating Environment.................................................................................................. 91

Rated Input Parameters................................................................................................... 91

Laser Specifications....................................................................................................... 91

Dimensions.............................................................................................................. 91


Electrical................................................................................................................. 92

Laser....................................................................................................................... 92

Laser Safety............................................................................................................. 92

RED-i Target Locator............................................................................................... 93

Objective................................................................................................................. 93

Care & Maintenance....................................................................................................... 93

Index.......................................................................................................................................... i


List of Figures

 

List of Figures

Figure 2-1. LYKOS laser objective............................................................................................... 6

Figure 2-2. Laser Controller and Accessories................................................................................. 6

Figure 2-3. RMS Thread Adapters and Thread Spacers................................................................... 7

Figure 2-4. 1.5mm Hex Head Drivers............................................................................................ 7

Figure 2-5. USB Security Key...................................................................................................... 7

Figure 2-6. C-Mount Adapters (representative samples)................................................................. 7

Figure 2-7. USB 3.0 Digital Camera, Cable and USB 3.0 Camera Hub............................................ 8

Figure 2-8. Foot Switch................................................................................................................ 8

Figure 2-9. Stage Micrometer....................................................................................................... 8

Figure 2-10. Dry Erase Marker and Cover Slips............................................................................. 9

Figure 2-11. Optional Compensator Cap........................................................................................ 9

Figure 2-12. Laser Case................................................................................................................ 9

Figure 3-1. LYKOS laser installation using Leica M25 RMS adapter............................................ 12

Figure 3-2. Laser Cable Attachment Reference Image.................................................................. 12

Figure 3-3. Laser Controller Rear Panel....................................................................................... 13

Figure 3-4. Laser Controller LED Status Bar............................................................................... 13

Figure 3-5. JAI Digital Camera Installation using Leica OEM C-Mount Adapter (example) and Connection to USB 3.0 Camera Hub.............................................................................................................................. 14

Figure 4-1. Software Layout....................................................................................................... 18

Figure 5-1. Laser Settings Main Screen....................................................................................... 21

Figure 5-2. Auto Labels............................................................................................................. 22

Figure 5-3. Programmable Field for Label Text............................................................................ 23

Figure 5-4. Image Capture.......................................................................................................... 23

Figure 5-5. Auto: Use Patient ID and Embryo ID......................................................................... 24

Figure 5-6. Save Mode............................................................................................................... 24

Figure 5-7. Laser Settings........................................................................................................... 25

Figure 5-8. Circle and Arrow Target Types.................................................................................. 26

Figure 5-9. Target Settings......................................................................................................... 26

Figure 5-10. Isotherm Rings Target Type.................................................................................... 27

Figure 5-11. Overlay Settings..................................................................................................... 29

Figure 5-12. Crosshairs Inner & Outer Radius.............................................................................. 29

Figure 5-13. Time Lapse Settings................................................................................................ 30

Figure 5-14. Video Settings........................................................................................................ 31

Figure 5-15. Camera Settings...................................................................................................... 32

Figure 5-16. Objectives Settings Panel........................................................................................ 33

Figure 6-1. HT Laser Target Slide............................................................................................... 35

Figure 6-2. Inked Coverslip and Vaporized Laser Spot on Inked Surface....................................... 36

Figure 6-3. RED-i Adjustment.................................................................................................... 38

Figure 6-4. Thread Spacer Rings for RED-i Alignment................................................................. 38

Figure 6-5. X Calibration Screen................................................................................................. 39

Figure 7-1. Patient Info.............................................................................................................. 41

Figure 7-2. Embryo Info Panel.................................................................................................... 42

Figure 7-3. Embryo Measurements............................................................................................. 43

Figure 7-4. Images Report Buttons.............................................................................................. 44

Figure 7-5. Change Data Field Label and Persist.......................................................................... 44

Figure 8-1. Thumbnail Gallery.................................................................................................... 45

Figure 8-2. Capture Options....................................................................................................... 46

| e |


Figure 8-3. Report Images.......................................................................................................... 46

Figure 8-4. Image Toolbox.......................................................................................................... 47

Figure 8-5. Image Toolbox: Saving............................................................................................. 48

Figure 8-6. Video Playback Controls........................................................................................... 50

Figure 9-1. Laser Mode Menu..................................................................................................... 51

Figure 9-2. Full Screen View: Clinical Mode............................................................................... 52

Figure 9-3. Laser Energy Level set to Off (left) and Medium (right).............................................. 52

Figure 9-4. Validation Control Panel........................................................................................... 54

Figure 9-5. Multipulse Laser Settings.......................................................................................... 55

Figure 9-6. Multipulse Control Panel........................................................................................... 55

Figure 10-1. Design View and Report View................................................................................. 57

Figure 10-2. Reports Template Panel........................................................................................... 58

Figure 10-3. Report Query.......................................................................................................... 58

Figure 10-4. Blank Report Template............................................................................................ 59

Figure 10-5. Report Design Menu............................................................................................... 59

Figure 10-6. Alignment Guide..................................................................................................... 60

Figure 10-7. Quick Properties Dialog........................................................................................... 61

Figure 10-8. Report Properties.................................................................................................... 61

Figure 10-9. Header, Body, Footer Properties............................................................................... 62

Figure 10-10. Image Properties................................................................................................... 63

Figure 10-11. Text Properties...................................................................................................... 64

Figure 10-12. ASCII Filter Panel................................................................................................. 66

Figure 11-1. LAH: Full Zona Breach (left); Zona Thinning (right)................................................. 68

Figure 11-2. Examples of Zona Openings for Blastomere Biopsy.................................................. 71

Figure 12-1. Save Support Package............................................................................................. 76

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

| f |


 

Index

 

 


A

activating the laser, 52

15 second timer, 53

add graphic elements to an image, 47

ADMIN notation, 2

Alpha, 29

altitude

operating environment, 77

applications, 67

laser-assisted blastomere biopsy, 70

laser-assisted hatching (LAH), 67

laser-assisted trophectoderm biopsy, 71

arrow targetTarget Type arrow, 26

arrow tool, 47

ASCII Export, 66

ASCII Filter, 66

Audio Feedback, 28

auto file storage

use report file name, 24, 31

use root name, 24, 31

Auto Labels, 21

auto labels

label properties, 22

name, 22

Auto White Balance, 32

Autosave on Capture, 24

 

B

blastocyst biopsy, 70

Body Properties, 62

 

C

calibration, 39

calibration procedure, 39

camera

digital, 8, 13, 14, 15

orienting to stage, 14

camera image flip, 32

camera port, 13

Camera Settings, 32

capture iimages, 46


capture imagaes

Capture on Laser Fire, 46

capture images

with video overlay, 46 Capture on Laser Fire, 46 caution, 2, 12, 13

circle target, 25

cleaning, 79

Clinical Laser panel, 52 Clinical Pulse Settings, 28 c-mount adapter, 5, 7, 13

Com port, 34

compensator cap, 5, 9

components, 5

computer connections desktop, 14

laptop, 15

control panel, 17

controller, 5

Copy report template, 57

Copy setup, 33

Crosshairs, 29

Crosshairs Setup color, 29

inner radius, 29

outer radius, 29

Cycle Number, 41

 

D

Data Fields, 44

Data Items, 60

Database, 75

Backup, 75

Optimize, 75

Restore, 75 Date of Birth, 41 DBPath, 64

delete images, 45, 49 Delete report template, 57 Delete setup, 33

deleting videos, 49

delimiter, 66

Design report template, 57

desktop computer connections, 14

digital camera, 14


 

 

| i |


 


foot switch, 15

keyboard, 15

monitor, 15

mouse, 15

power, 15

security key, 15

speakers, 15

digital camera, 8, 14, 15

desktop computer connection, 14

installation, 13

laptop computer connection, 15

disinfection, 79

drill tool type, 43

dry erase marker, 5, 9, 36

 

E

Edit Label Location, 22 electrical specifications input voltage, 78

line frequency, 78

power, 78

ellipse tool, 47

Embryo ID, 41

Embryo Info, 41

Embryo panel, 18 embryo tool type, 43 Embryos in Cycle, 41 enable button

Multipulse Mode, 55

Enable Duration, 55

Enable label, 22

 

F

failed drilling, 70

Fertilization Method, 41

Fire Animation, 27

Fire button, 53

firing the laser, 53

15 second timer, 53

Multipulse Mode, 56

First Name, 41

Flip Horizontal, 32

Flip Vertical, 32

focus, 67

foot switch, 5, 8

desktop computer connection, 15

Footer Properties, 62

FPS, 32


FPS Actual, 32 frames per second, 32 Full Screen Mode, 51

Image Toolbox, 48

full zona breaching, 67

 

H

Halt button

Multipulse Mode, 56

Header Properties, 62

Help, 75

hex head drivers, 7

high laser energy level, 52

laser-assisted hatching, 68

high pulse duration, 28

high pulse setting, 28

 

I

Image, 60

Image and Video Control Panel, 18

Image Capture

Autosave on Capture, 24 Image File Name Label, 24 Image Type, 23

Save Location, 23, 31

Save Mode, 24, 31

Watermark, 24

Image Capture Settings, 23

Image Capture Setup, 23

auto, 24, 31

manual, 24, 31

Image File Name Label, 24

Image Properties, 63

Image Toolbox, 47

arrow tool, 47

ellipse tool, 47

line tool, 47

measurement tool, 47

rectangle tool, 47

text tool, 47

undo button, 48

Image Type, 23

images

adding to report, 46 capturing, 46 closing

closing images, 46

deleting, 45, 49


 


Image Toolbox, 47

opening, 45, 49

save with overlays, 44

saving, 45, 49

viewing, 46

Images panel, 18

Info

Embryo, 41

inner radius, 29

input voltage, 78

installation

preparing for, 9

Isotherms

activating rings, 27

colors, 26

peak temperature, 26

Isotherms target, 26

 

K

keyboard

desktop computer, 15

 

L

label properties, 22

LAH, 67

laptop computer connections, 15

digital camera, 15

mouse, 16

power, 16

security key, 16

Laser

Enable, 25

Laser - Clinical panel, 17

laser applications, 67

laser case, 9

laser controller, 5, 6

LED status bar, 13 LYKOS installation, 12 serial cable connection, 13

serial to USB connection, 13

USB cable connection, 13

Laser Mode Menu, 51

laser objective, 6

Laser Objectives, 34

laser panel

Clinical, 52

Multipulse, 54, 55

Validation, 53


laser safety, 78

Laser Settings, 25

Audio Feedback, 28 Clinical Pulse Settings, 28 Fire Animation, 27

Laser, 25

Pulse Resolution, 28

Remote Fire, 25

Scale, 30

Target Type, 25

Laser Setup

max mean power, 55

Multipulse Mode, 55

target type, 25

laser specifications, 78

Laser Target, 35

Laser Target X and Y values, 34 laser-assisted blastomere biopsy, 70 laser-assisted hatching, 67

full zona breaching, 67

laser positioning, 67

procedure summary, 69

zona thinning, 68

laser-assisted trophectoderm biopsy, 71

manual pulses, 71

multipulse mode, 72

Last Name, 41

line frequency, 78

line tool, 47

low laser energy level, 52

laser-assisted hatching, 68

low pulse duration, 28 low pulse setting, 28 LYKOS installation

laser controller, 12

RMS thread adapters, 11

 

M

Magnification Calibration, 33

X Micron/Pixel, 33

Y Micron/Pixel, 33

magnification calibration, 39

Main Menu, 18

Manual file storage

ask for file name, 24, 31

measurement tool, 47

medium laser energy level, 52

laser-assisted hatching, 68 medium pulse duration, 28 medium pulse setting, 28


 

| iii |


 


micrometer, 5, 8

microscope

camera port, 13

monitor

desktop computer connection, 15

mouse

desktop computer, 15

laptop computer connection, 16 multiple manual pulses, 69 Multipulse Laser panel, 54

enable, 55

halt button, 55

power, 55

pulse duration, 55

pulses/sec, 55

total duration, 55

Multipulse Mode, 54 firing the laser, 56 notes, 73

 

N

New Folder, 57

New setup, 33

New Template, 57

designing new report, 58

Note, 41

note, 2, 12

Number, 43

 

O

Objective Info, 33

Description, 33

Name, 33

Type, 33

objective specifications, 79

Objectives Settings, 33

Objectives Setup Com port, 34

open images, 45, 49

opening videos, 49

operating current, 77

operating environment, 77

altitude, 77

relative humidity, 77

temperature, 77

operating frequency, 77

operating voltage, 77

Optics Settings, 32


Camera, 32

Objective, 33

outer radius, 29

Overlay Settings, 29

Crosshairs, 29

 

P

Page Number, 60

Patient ID, 41

Patient Info, 41 Patient Info panel, 18 Persist, 44

Physician, 41

Playback Speed, 30

playing videos, 50

PN 1

PN 2, 43

power, 15, 16

electrical specifications, 78

Multipulse Mode, 55

Validation Mode, 53

Power Limit, 55, 56

print image, 48

Programmable Fields, 22 pronucleus tool type, 43 Properties Panel, 61 pulse duration

Multipulse Mode, 55

Validation Mode, 53

Pulse Resolution, 28

Pulse Settings

Clinical Pulse Settings, 28

Pulse Resolution, 28

pulses/sec

Multipulse Mode, 55

 

Q

Quick Properties Tool, 60

 

R

real time video capture, 49

rectangle tool, 47

RED-i

brightness, 17

enable, 17

Intensity Slider, 17, 38

RED-i specifications, 79


 


RED-i target alignment, 38

relative humidity

operating environment, 77

Remote Fire, 25

Report Date & Time, 60

report images, 46

Report Layout, 61

Report Properties, 61

Report Template Body, 62

Copy, 57

Delete, 57

Design, 57

design area, 59

Footer, 62

Header, 62

Image Properties, 63

New Folder, 57

New Template, 57

Properties, 60

Properties Panel, 61

Text Properties, 64

Toolbox, 60

View, 57

Report template adding items, 59

Report Templates layout aids, 60

Resize, 32

Retrieval Date, 41

RMS thread adapters, 5, 7, 11

 

S

safety delay, 27

save image to thumbnail gallery with graphic overlay, 48

save images, 45, 49

Save Location, 23, 31

Save Mode, 24, 31

Save Support Package, 76

saving videos, 49

Scale, 30

security key, 5, 7, 15

desktop computer connection, 15

laptop computer connection, 16

setting the laser power Validation Mode, 54

setting the pulse Validation Mode, 54

Settings


Auto Labels, 21

Image Capture, 23

Laser, 25

Optics, 32

Overlay, 29

Time Lapse, 30

Setup

Delete, 33

Setups

Copy, 33

New, 33

software layout, 17

speakers, 15

special notations ADMIN, 2

caution, 2, 12, 13

note, 2, 12

specifications, 77

stage micrometer, 5, 8

Standard Items, 60

system

magnification calibration, 39

 

T

target alignment, 35, 67

HT Laser Target slide, 35

RED-i, 38

vaporized ink spot, 36

Target Type, 25

circle, 25

Isotherms, 26

target type, 25

temperature

operating environment, 77

Text Label, 60

Text Properties, 64

text tool, 47

thread adapters RMS, 5, 7, 11

thread spacer rings, 38 Thumbnail Gallery, 18, 45 Time Lapse

Playback Speed, 30 Time Lapse Duration, 30 Time Lapse Interval, 30 Time Lapse Settings, 30 Time Lapse videos, 49 tool type

drill, 43

embryo, 43


 

| v |


 


pronucleus, 43

zona, 43

total duration

Multipulse Mode, 55

trophectoderm biopsy, 71

manual pulses, 71

multipulse mode, 72

troubleshooting failed drilling, 70

 

U

undo button, 48

USB security key, 5, 7, 15

 

V

Validation Laser panel, 53

Validation Mode, 53

video window, 17

videos

capturing real time videos, 49 capturing time lapse videos, 49 deleting, 49

opening, 49

saving, 49

videso

playing, 50

View report template, 57

viewing images, 46

 

W

Watermark, 24

White Balance, 32

With Video Overlays, 46

 

X

X Magnification Calibration, 39

X Micron/Pixel, 33

 

Y

Y Magnification Calibration screen, 39

Y Micron/Pixel, 33


Z

zona thinning, 68

zona tool type, 43