User Manual

S A T U R N™ 5 L A S E R S Y S T E M S

+45 46 79 02 02 | [email protected] | coopersurgical.com

Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-47-500UM(15) | DRF 4915 | 25th June 2019 0120
0120 only
CONTENTS

SECTION 1 - PREFACE 4

SECTION 2 - INTRODUCTION TO THE SATURN 5 LASER SYSTEM 5

Intended Use 5
Indication for Use - USA Customers Only  5
Applicable Part Numbers 5
Microscope Compatibility 5
Installation 6

SECTION 3 - SAFETY  7

Cautions and Warnings 7

Precautions 9
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions (IEC 60601-1-2) 9
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity 10
Safety and Information Symbols  12

SECTION 4 - PRODUCT OVERVIEW 13

System Components 13
Saturn 5 Laser System Component Part Numbers 14
Saturn 5 Active Laser System Mirror Module Part Numbers 14
Saturn 5 Laser System Collimator Module Part Numbers 15
Hardware Overview 15
Laser Specifications 16
Objective Specifications  16
Saturn Active Specifications  16
Electrical Specifications  16
Mains Adaptor for Control Unit and Motor Module 16
Dimensions  16
Operating Conditions  16
Storage/Transport Conditions 16

SECTION 5 - RI VIEWER 17

Introduction 17
User Interface Icons 17
How to Zoom & Pan the Image 18
There are three ways to zoom into an area on the screen. 18
How to Set the Preset Zoom 18
How to Select Cameras 18
Camera Flipping 18
Changing Camera Settings 19
Objectives 19
How to Select Objectives 19
How to Add Objectives 19
How to Remove Objectives  19
How to Check Objective Calibration 19
How to Configure the Foot Pedal/Keyboard 20
How to Perform Measurements 21
How to Take a Picture 21
How to Record Video 21
RI Viewer Gallery  22

SECTION 6 - SATURN 5 LASER SYSTEM INTENDED USES 28

Laser Assisted Hatching 28

Embryo Biopsy Procedure 28
Cleavage Stage Blastomere Biopsy 28
Trophectoderm/Blastocyst Biopsy 29
Blastocyst Collapse 29

SECTION 7 - LASER ABLATION PROCEDURE 30

Hole Size Selection 31

Ablation Procedure  31

SECTION 8 - LASER OPERATION 33

How to Start Up 33

How to Configure the Laser for a New Procedure 33
How to Check Laser Target Alignment for Saturn 5 Active Laser System 33
How to Check Laser Target Alignment for Saturn 5 Fixed Laser System 34
How to Check Hole Size Calibration 34
How to Remove a Point from the Hole Size Calibration Graph 35
Laser Target 35
Hole Size Indicator  35
Exclusion Zone 35
How to Adjust Hole Size/Pulse Width 36
Preset Pulse Widths 36
How to Fire the Laser (Single Pulse) 36
Biopsy Mode 37
How to Enable Biopsy Mode 37
How to Fire the Laser (Biopsy Mode) 37
How to Shut Down 37

SECTION 9 - TROUBLESHOOTING FOR SATURN 5 LASER SYSTEM 38

SECTION 10 - CARE AND MAINTENANCE 39

Cleaning 39
Servicing 39
Disposal of Goods 39

SECTION 11 - WARRANTY INFORMATION AND LIMITS ON LIABILITY 40

SECTION 12 - RETURNING PRODUCT TO RI FOR REPAIR 41

Obligation to Inform 42
Feedback 42
 Section 1
Preface Research Instruments Ltd

1 SECTION 1 - PREFACE

Thank you for choosing the Saturn 5 Laser System.

This manual provides all necessary information to use the Research Instruments Ltd Saturn 5 Laser
System. The system should be operated by trained personnel only. All sections of this manual should
be read and understood fully before any operation of the system. Please see the Intended Use for more
information.
If the operator is unsure of any of the information contained in this manual, they should contact
Research Instruments or an appointed representative before attempting to use this equipment.
In no event does Research Instruments Ltd (RI) assume the liability for any technical or editorial errors
of commission, or omission; nor is Research Instruments Ltd liable for direct, indirect, incidental, or
consequential damages arising out of the use or inability to use this manual.
© This manual is protected by copyright, all rights reserved, and no part hereof may be photocopied or
reproduced in any form without the prior written consent of Research Instruments Ltd.
Saturn™ and RI Viewer™ are trademarks of Research instruments Ltd. All other brand names are
trademarks of their respective owners.
The information in this manual is current at the time of publication. RI is constantly updating its
products, and, therefore, reserves the right to introduce changes in design, equipment and technical
features at any time. The latest version of the User Manual as well as RI Viewer software can be
downloaded from software.research-instruments.com.

The Saturn 5 Laser System manual belongs with the laser and should be passed on with the Saturn 5
Laser System if relocated to another clinic.

4
 Section 1
Research Instruments Ltd Preface

SECTION 2 - INTRODUCTION TO THE SATURN 5 LASER SYSTEM

1
Intended Use
The Saturn Laser System is intended to ablate a User defined section of a gamete or embryo
within ART.

0120
0120

Indication for Use - USA Customers Only

For use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to
facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres).
The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-
implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.

only
Caution: Federal law restricts this device to sale by or on the order of a physician or a practitioner
trained and certified in its use

Applicable indications for use are subject to the regulations of the country into which the device is sold.

Applicable Part Numbers

6-47-500 - Saturn 5 Active Laser System

6-47-501 - Saturn 5 Fixed Laser System

Microscope Compatibility

Zeiss Axiovert 40/100/200/Observer

Nikon TMD, D200/300, TE200/300, TE2000, Ti, Ti2
Leica DMIRB, DMI3000B/4000B/6000B, DMIL, DMi8
Olympus IMT2, IX50/70, IX51/71/81, IX53/73/83

5
Section 2
Introduction to Saturn 5™ Laser Systems Research Instruments Ltd

Installation

The PC is an intrinsic part of the Saturn 5 Laser System. It may be connected to a Local Area Network
(LAN) only. Only install RI Viewer software. We recommend PC security features such as anti-virus

2
software/firewall be installed consistent with the facility’s IT policy and that each user of the system
has a password protected user profile assigned to the PC in order to prevent unauthorised access.
Installation of the Saturn 5 Laser System should be carried out by a Research Instruments technician
or other RI-authorised personnel. Incorrect installation could result in reduced power output, laser
misalignment or laser malfunction. Relocation of this system should be treated as a re-installation and
should, therefore, be carried out by authorised personnel.
Please note that installation and servicing is covered separately in the Saturn 5 Laser System Installation
Manual (6-47-500IM), which is available to service providers.

A Patients Guide to Laser Assisted Hatching (LAH), Laser Assisted Biopsy (LAB) and Blastocyst
Collapse are provided on the RI Viewer software. RI Viewer software can be downloaded from
http://software.research-instruments.com
Once installed, the RI Viewer application can be started by double clicking the RI Viewer icon on the
desktop.

6
 Section 3
Research Instruments Ltd Saturn™ 5 Laser Systems Safety Warnings

SECTION 3 - SAFETY

Cautions and Warnings

Laser radiation is present within the control unit, the fibre optic patch lead and through the micro-
scope to output at the objective. The Saturn 5 Laser System has been designed to ensure that emis-

3
sion of laser radiation at any point is within the limits stipulated by international safety standards,
IEC 60825-1:2014, and US 21CFR1040.10 for unprotected viewing (Class 1). As an extra precaution, an
infrared blocking filter has been incorporated into the optical path leading to the eyepieces to reduce
laser emission by a further 99%.
For a description of controls and for the location of laser aperture on control unit, see Section 4 -
Hardware Overview.

CAUTION Hazardous radiation exposure may occur through the use of controls, executing
adjustments or the performance of procedures other than those specified herein. Servicing
and adjustment other than that specified in this manual should only be carried out by RI
or RI authorised agents.

DO NOT disassemble or modify any part of the Saturn 5 Laser System, or substitute any
component for any other. Doing so may result in exposure to dangerous levels of laser
radiation. This voids the warranty and/or service contract.

DO NOT operate the laser unless it is properly mounted to a microscope.

ONLY use the power cable and power supply adaptor supplied with the system.
The cable to the power supply is the Disconnect Device for this equipment. To remove all
electrical power from this product, disconnect the power cable from the electrical outlet.
Equipment should be positioned so as to allow easy access to the power cable. The appliance
coupler or mains plug is used as the disconnect and must remain readily operable.

WARNING To avoid the risk of electric shock, this equipment must only be connected to
a mains supply with protective earth.

WARNING Not to be used in a patient environment

This indicates cautionary text which should be followed to avoid injury to users or damage
to samples.

The system should be operated by qualified and trained personnel only.

7
 Section 3
Saturn™ 5 Laser Systems Safety Warnings Research Instruments Ltd

WARNING Before performing any procedure, the pilot laser must be used to check
the alignment of the Active positioning system. The system must be re-aligned when
necessary. See Section 8 How to Check Laser Target Alignment.

WARNING Thermal lensing is a defocusing of the laser beam caused by changes to

the refractive index of the medium as it is heated. The degree of defocus depends on
the total beam energy deposited in the medium. While slight defocus has no effect on

3 the drilling properties, this effect may become a problem for higher beam energies. To
eliminate any significant effects from thermal lensing, we recommend that the pulse
width be kept below 1000μs for clinical Laser Assisted Hatching (LAH) zona drilling.

WARNING Only a single opening should be made in the zona pellucida. Multiple openings
or those that are too small may prevent embryo hatching or lead to abnormal development.

WARNING Do not operate the pilot laser with an embryo in the field of view. Exposure
to the pilot laser may damage the embryo.

WARNING The microscope itself must be maintained to a high standard. Problems such
as worn focus mechanisms or an insecure video camera may lead to unreliable focus and
image stability, and could lead to embryo damage.

WARNING The embryo may be damaged if objectives other than the red Saturn 5 Laser
System objective are used.

WARNING Do not modify this equipment without authorisation of the manufacturer.

WARNING Where an ITO glass heated stage is fitted, do not fire the laser with the
microscope focussed into the ITO glass surface as this may damage the ITO coating.

8
 Section 3
Research Instruments Ltd Saturn™ 5 Laser Systems Safety Warnings

Precautions

• To minimise the risk of damage to blastomeres, administer as few laser pulses as possible at the
lowest energy levels possible to achieve the prescribed zona drilling or thinning effect.
• Direct the laser beam toward a section of the zona pellucida where the adjacent perivitelline space
is widest or next to an area of fragmentation.
• A holding pipette should be used during laser treatment to minimise the risk of embryo movement.
• Small openings in the zona pellucida may lead to embryo constriction and abnormal development. 3
• To date there are no known reports showing a greater occurrence rate of major or minor defects
in children derived from laser-hatched embryos. Long-term follow-up data on children born from
laser-hatched embryos does not yet exist. A study of 134 such babies* found no increase in the major
congenital malformations, chromosomal aberrations or minor congenital malformations between
the LAH treated group and all deliveries at their hospital.
• The device is not affected by and does not present any reciprocal interference to the microscope.
• During normal use there is no contact with patient/sample.

*Kanyo, K., Konc, J. “A follow-up study of children born after diode laser assisted hatching.” European
Journal of Obstetrics and Gynaecology. 110: 176-180 (2003).

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions (IEC 60601-1-2)

The Saturn 5 Laser System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Saturn 5 Laser System should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -

guidance
The Saturn 5 Laser System uses
RF energy only for its internal
RF emissions function. Therefore, its RF
Group 1 emissions are very low and are
CISPR 11
not likely to cause
any interference in nearby
electronic equipment.

The Saturn 5 Laser System

is suitable for use in all
RF emissions establishments, including
Class B
CISPR 11 domestic establishments and
those directly connected to
the public low-voltage power
Harmonic emissions supply network that supplies
Class A
IEC 61000-3-2 buildings used for domestic
Voltage fluctuations/flicker purposes.
Complies
emissions

9
 Section 3
Saturn™ 5 Laser Systems Safety Warnings Research Instruments Ltd

USA Only
Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
“This is a class A product. In a domestic environment this product may cause radio interference in
which case the user may be required to take adequate measures.”

Guidance and Manufacturer’s Declaration — Electromagnetic Immunity

3 The Saturn 5 Laser System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Saturn 5 Laser System should ensure that it is used in such an environment.

IMMUNITY test IEC 60601 Compliance level Electro magnetic environment -

Test level guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete
discharge (ESD) ± 8 kV air ± 8 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ± 1 kV for input/ ± 1 kV for input/ hospital environment.
output lines output Lines
Surge ± 1 kV line(s) to ± 1 kV differential Mains power quality should be
IEC 61000-4-5 line(s) Mode that of a typical commercial or
± 2 kV line(s) to earth ± 2 kV common hospital environment.
mode
Voltage <5% UT <5 % UT Mains power quality should be
dips, short (>95% dip in UT ) for (>95 % dip in UT) for that of a typical commercial
interruptions and 0.5 cycle 0.5 cycle or hospital environment. If
voltage variations 40% UT 40 % UT the user of the Saturn 5 Laser
on power supply (60% dip in UT) for 5 (60 % dip in UT) for System requires continued
input lines cycles 5 cycles operation during power mains
IEC 61000-4-11 70% UT 70 % UT interruptions, it is recommended
(30% dip in UT) for 25 (30 % dip in UT) for that the Saturn 5 Laser System be
cycles 25 cycles powered from an uninterruptible
<5 % UT <5 % UT power supply or a battery.
(>95 % dip in UT) for (>95 % dip in UT)
5s for 5s
Power frequency 3 A/m 0.3 A/m The power frequency magnetic
(50/60 Hz) field should be measured in the
magnetic field intended installation location to
assure that it is sufficiently low.
IEC 61000-4-8

Note: UT is the a.c. mains voltage prior to application of the test level.

10
 Section 3
Research Instruments Ltd Saturn™ 5 Laser Systems Safety Warnings

Guidance and Manufacturer’s Declaration — Electromagnetic Immunity Continued

IMMUNITY IEC 60601 Compliance Electro magnetic environment - guidance

test Test level level
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
equipment should be used no closer to any part
IEC 61000-4-6 150 kHz to 80 MHz of the Saturn 5 Laser System including cables,
than the recommended separation distance
3
Radiated RF 3 V/m 3 V/m calculated from the equation applicable to the
frequency of the transmitter.
IEC 61000-4-3 80 MHz to 2.5 GHz
Recommended separation distance
d = 1,2√P
d = 1,2√P 80 MHz to 800 MHz
d = 2,3√P 800 MHz to 2 , 5 GHz where P
is the maximum output power rating of
the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range. b

Interference may occur in the vicinity of

equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the Saturn 5 Laser System is used exceeds the applicable RF compliance level above, the Saturn
5 Laser System should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Saturn 5 Laser System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

11
 Section 3
Saturn™ 5 Laser Systems Safety Warnings Research Instruments Ltd

Safety and Information Symbols

Source: BS EN ISO 15223-1:2016

BS EN 60601-1:2006+A12:2014
Symbol Meaning

In accordance with Annex II of the European Medical Device Directive 93/42/EEC,

as amended by Directive 2007/47/EC under the supervision of notified body SGS
0120
0120
Caution: US Federal law restricts this device for sale to or on the order of a
3 Only licensed healthcare practitioner

Indicates the need for the user to consult the instructions for use for
important cautionary information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the medical device itself

Manufacturer

Date of Manufacture

Reference number

Serial Number

Refer to Instruction manual

Consult instructions for use

Direct current (DC)

CLASS 1
LASER PRODUCT Class 1 laser product (IEC60825-1:2014)

Do not dispose of product with normal waste

Disposal of according to EU WEEE Directive

This way up

Fragile, handle with care

3
Stacking limited to 3 units

Keep dry

12
 Section 4
Research Instruments Ltd Saturn™ 5 Laser Systems Product Overview

SECTION 4 - PRODUCT OVERVIEW

Welcome to the User Manual for the Research Instruments Saturn 5 Laser System. This manual covers
the set-up, operation and maintenance of the system.
This device is for use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo
to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres).
The device can also be used on blastocyst stage embryos for the biopsy of trophectoderm cells for pre-
implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.
The system is used with an inverted microscope, PC and camera to provide an optical system and means
of firing a laser. The system cannot be used without a PC or RI Viewer software.
The Saturn 5 Laser System is offered in two options, Fixed or Active models. The Active model allows
the user to move the position of the laser to the target area on the sample. The Fixed model has the
4
laser in a fixed position and the user moves the sample to the target.
All laser movement (Active model only) and laser firing is user controlled.

System Components

Power Supply
Mirror Module

Control Unit
Motor Module
Objective

Patch Lead
Note: Actual components may differ from those shown.
The Saturn 5 Laser System comes supplied with the following parts: a control unit containing the lasers,
a mirror module, armoured patch lead and a special objective. If you have a Saturn 5 Active Laser System
then an additional motor module will be supplied. The laser beams are delivered to the specimen through
a fibre optic patch lead, collimator module (that is part of the mirror module for a Fixed system or the
motor module for an Active system) and the special objective.
A foot pedal for firing the laser is available as an optional extra. This is attached to the PC by a USB cable.
The motor module receives coordinates via the USB which moves the motors to those coordinates. The
control unit then receives commands from the software to fire for a specific length of time.

13
 Section 4
Saturn™ 5 Laser Systems Product Overview Research Instruments Ltd

The following tables give part numbers of system components and microscope adaptors. All parts are
supplied or manufactured by Research Instruments Ltd.

Saturn 5 Laser System Component Part Numbers

Part Number Description

5-47-010 Control Unit with 1.5m Patch Lead
5-47-100 Motor Module (Saturn 5 Active Laser System)
1-10-133 12V 3.3A Medical PSU (x2 for Saturn 5 Active Laser System)
5-45-500 Laser Objective (red) 40x
5-45-507 Laser Objective (red) 20x*
4
Saturn 5 Active Laser System Mirror Module Part Numbers

Part Number Description

5-46-163 Mirror module for Olympus IX53/73/83 left
5-46-150 Mirror module for Olympus IX50/70 left
5-46-160 Mirror module for Olympus IX50/70 right
5-46-151 Mirror module for Olympus IX51/71/81 left
5-46-152 Mirror module for Olympus IX51/71/81 right
5-46-159 Mirror module for IMT2
5-46-135 Mirror module for TMD
5-46-132 Mirror module for Nikon Diaphot 200/300
5-46-130 Mirror module for TE 200/300
5-46-140 Mirror module for TE2000 with Integra Ti
5-46-141 Mirror module for TE2000 without Integra Ti
5-46-142 Mirror module for Nikon Ti with Integra Ti
5-46-144 Mirror module for Nikon Ti with X-Y
5-46-146 Mirror module for Nikon Ti2 with Integra
5-46-148 Mirror module for Nikon Ti2 with XY stage
5-46-158 Mirror module for Axiovert 40
5-46-110 Mirror module for Axiovert 200/Observer
5-46-120 Mirror module for DMIRB
5-46-122 Mirror module for DMI3000B
5-46-121 Mirror module for DMI4000B/6000B
5-46-124 Mirror module for DMi8

*Not cleared for use in USA market.

14
 Section 4
Research Instruments Ltd Saturn™ 5 Laser Systems Product Overview

Saturn 5 Laser System Collimator Module Part Numbers

5-45-163 Collimator module for Olympus IX53/73/83

5-45-383 Collimator module for Olympus IX50/70
5-45-387 Collimator module for Olympus IX51/71/81
5-45-388 Collimator module for Olympus IX71/71/81 fluor
5-45-580 Collimator module for IMT2
5-45-411 Collimator module for TMD
5-45-301 Collimator module for Nikon Diaphot 300/TE300
5-45-545 Collimator module for TE2000/Nikon Ti
5-45-546 Collimator module for TE2000/Nikon Ti fluor 4
5-45-575 Collimator module for Axiovert 40
5-45-009 Collimator module for Axiovert 100
5-45-011 Collimator module for Axiovert 200/Observer
5-45-450 Collimator module for DMIRB
5-45-470 Collimator module for DMIL
5-45-461 Collimator module for DMI3000B
5-45-460 Collimator module for DMI4000B/6000B
5-45-463 Collimator module for DMi8

Hardware Overview

Device Label

FOLLOW
INSTRUCTIONS
USE AC ADAPTOR LASER OUTPUT
FOR USE (01) 0XXXXXXXXXXXXXX 1-10-133
AAMI ES60601-1
CSA C22.2 No. 60601-1
UDI (11) YYYY-MM-DD
(21) XXXX
12V 3.3A
KEEP CLEAN

E113973
PILOT Saturn 5 Laser System Research Instruments Ltd, Bickland Industrial Park,
CLASS 1
REF: 6-47-5XX Falmouth, Cornwall, TR11 4TA, UK LASER PRODUCT
YYYY-MM-DD SN: XXXX coopersurgical.com PC 2-47-012AR(11)

15
 Section 4
Saturn™ 5 Laser Systems Product Overview Research Instruments Ltd

Laser Specifications
Laser Specifications Ablation Laser Pilot Laser
Output wavelength 1480nm 650nm
Power output from patch lead 400mW 180µW (max)
Maximum pulse width 2.0ms None
Laser Safety Classification* Class 1 Class 1
* IEC 60825-1:2014, US 21CFR 1040.10
Objective Specifications
Magnification 40x 20x*
N.A. 0.49 0.25

4 Working distance
Parfocal distance
2.5mm 2.5mm
45mm (adaptor supplied for Nikon CFI60 systems)
* Not cleared for use in USA market.
40x or 20x is a nominal figure. Actual magnification will vary slightly when fitted to different microscopes.
Manufacturer Actual Magnification
Olympus 40x, 20x
Nikon (CFI60) 36x, 18x
Leica 36x, 18x
Zeiss 44x, 22x

Saturn Active Specifications

Range of Movement Approx. 370μm (40x), 740μm (20x)
Accuracy 1μm within calibration area, 3μm outside (see page 33)

Electrical Specifications
Mains Adaptor for Control Unit and Motor Module
Input 100-240VAC, 50-60Hz, 1.0 - 0.5A
Output Power (maximum) 40W
Voltage 12VDC
Current (maximum) 3.3A
Earth Connection Mandatory 3-pin plug for earthing (grounding)
Dimensions
Control unit 220mmx180mmx34mm (8.6”x7.1”x1.3”)
Weight 1.2Kg

Operating Conditions
Temperature 10°C (50°F) to 42°C (108°F)
Humidity 15% to 85% RH (Non-condensing)
Pressure Pressure Range: 70kPa. to 108kPa

Storage/Transport Conditions
Temperature -40°C (40°F) to 60°C (140°F)
Humidity 15% to 85% RH (Non-condensing)
Pressure Pressure Range: 70kPa. to 108kPa.

16
 Section 4
Research Instruments Ltd Saturn™ 5 Laser Systems Product Overview

SECTION 5 - RI VIEWER
Introduction

RI Viewer is the software that interacts with the Saturn 5 Laser System for use within an ART laboratory.
Connected to a camera attached to a microscope, it provides on-screen images of samples under the
microscope. It can record video and store still images from the microscope in a PC’s file system. End
users should ensure their own PCs are certified compliant to IEC 60950-1.
The operator should be positioned to easily access the microscope and also view the image on the PC
monitor.
RI Viewer software can be downloaded from http://software.research-instruments.com
Once installed, the RI Viewer application can be started by double clicking the RI Viewer icon on the
desktop.
4

User Interface Icons

Icon Meaning Icon Meaning

Take Picture Laser Control

Take Video General Settings

Stop Video Additional Camera

Recording Settings

Open RI Viewer Take Measurements

Gallery

Choose Objective
Display Rulers Tool
Magnification

Increase/Decrease
Instructions For Use
Zoom Level

17
 Section 5
RI Viewer ™ Research Instruments Ltd

How to Zoom & Pan the Image

There are three ways to zoom into an area on the screen.

1. Place the mouse at a point on the screen and click and hold the right mouse button then release.
This will zoom into the spot where the mouse is placed. To zoom out, click and hold the right mouse
button.
2. Place the mouse at a point on the screen and use the scroll wheel on the mouse (if available).This
will give the user control over how much digital zoom is given.
3. Using the tool bar at the bottom of the screen, click the + icon to zoom in incrementally. To zoom
out by the same amount, click on the - icon on the tool bar. The magnifying glass icon will zoom in
and out by the preset zoom.
Whilst using digital zoom, a thumbnail image of the screen will appear in the top left of the screen. At
the top of this panel is the amount of magnification you are using. When zoomed out fully, this panel
will not appear on the screen.

5
Zooming in and zooming out can also be achieved using the foot pedal. (see page 20)

How to Set the Preset Zoom

1. Click the Additional Camera Settings icon on the tool bar.

2. Drag the Preset Zoom slider to the required zoom.

How to Select Cameras

1. Click the General Settings icon on the tool bar. The Video Source drop-down box will have a list of
camera names referring to the cameras connected to the PC.
2. Click on the drop-down box to allow the selection of cameras. Clicking on the required camera in
the list will change the live image to that of the selected camera.
Note: The list of available cameras is automatically populated to show the attached devices. Camera
names in this list cannot be altered by the user.

Camera Flipping

1. Click the General Settings icon on the tool bar.

2. Tick Flip Video Horizontal (for camera devices that support these options).
3. Tick Flip Video Vertical (for camera devices that support these options).

Camera flipping is for microscopes where the camera image may be required to be inverted. This is
carried out during installation where a camera port requires camera flipping to show the image correctly
on the screen. This will be carried out by a trained RI Service Engineer or company representative. When
camera flipping is required it is recommended to carry out Laser Target Alignment as per instructions
before carrying out any procedure.

18
 Section 5
Research Instruments Ltd RI Viewer™

Changing Camera Settings

Clicking the Additional Camera Settings icon on the tool bar will show a panel indicating the camera
name and frames per second (fps). Clicking on Additional Settings will allow the user to adjust settings
on the video source. Only settings available to the video source chosen will appear.

Objectives

Objectives can be changed on the microscope to enable the user to get a better field of view or better
magnification. If you require accurate measurements of the image, the objective chosen in RI Viewer
must be the same magnification as the objective in use on the microscope.

How to Select Objectives

1. Click the Choose Objective Magnification icon on the tool bar. 5

2. Click the required objective magnification.

How to Add Objectives

1. Click Display Rulers Tool icon on the tool bar.

2. Click the Objective Calibration button.
3. Click New Objective. The magnification will be the same as the current magnification.
4. Click the required objective to edit Objective Magnification and Fine Adjustment values.

How to Remove Objectives

1. Click Display Rulers Tool icon on the tool bar.

2. Click the Objective Calibration button.
3. Click X next to the objective to be removed.

How to Check Objective Calibration

1. Click the Display Rulers Tool icon on the tool bar.

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RI Viewer ™ Research Instruments Ltd

2. Click the Objective Calibration button to open the

Objective Calibration panel.

3. Place an object of known dimensions (a stage micrometer

is supplied with each system for this purpose) in the field of

5
view.
Ensure that the objective selected in RI Viewer matches
that being used on the microscope.

4. The stage micrometer supplied measures 100µm between

the longer lines. For best accuracy, position each end point
of the line at exactly the same relative position on the
scale, for example at the right hand edge of each vertical
line.
5. Drag the rulers to the point where the stage micrometer
is going to be measured from and use the fine adjustment
up and down until the ruler scale matches the stage
micrometer.

How to Configure the Foot Pedal/Keyboard

1. Click the General Settings icon on the tool bar.

2. From the Settings panel click the Keyboard/Foot Pedals Shortcuts.
3. Click the corresponding edit button to assign a shortcut.
4. Hold down the key or press the foot pedal to assign.
5. Click Save and Quit.

Once the shortcuts are set up, press the shortcut keys or the corresponding foot pedal to activate the
command.

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Research Instruments Ltd RI Viewer™

How to Perform Measurements

1. Click the Take Measurements icon on the tool bar.

2. Click on the screen to select a start point for the measurement.
3. Click on the screen a second time to select an end point for the measurement.
The ends of the line can be dragged to change the measurement.
Lines can be removed by clicking the cross in the context window.
Lines are shown during laser operation but cannot be dragged or created and no measurements will
be displayed.
Lines and measurements are shown on an image when images are taken in line mode or laser mode.

How to Take a Picture

5
1. Click the Take Picture icon on the tool bar.
2. A camera icon will flash briefly in the centre of the screen to let the user know that an image has
been taken.
Images can be stored in a .bmp file format or .jpg file format. This is configurable from the Settings menu
by checking Compress Images. If this box is ticked the images are saves as .jpg files, if not they are are
saved as .bmp files.
Images are named by default (date and time) yyyymmddhhmmss.bmp. For example, a picture taken
on the 3rd of January 2012 at 10:35:02 would be named 20120103103502.bmp.

How to Record Video

1. Click the Take Video icon on the tool bar.

2. Whilst video is being captured, a recording notification will flash in the top left corner of the
screen.
3. Click the Stop Video Recording icon on the tool bar and the recording notification will stop.

Each video recording can last for a maximum of one hour. This eliminates the problem of
accidentally leaving the software recording with the possibility of rendering the computer
unusable.
4. When Freeze Frame is set as keyboard shortcut, the live image can be paused. A second press of
the shortcut key will restart the live image.
Recorded videos are stored in a .wmv file format
Recorded videos are named by default (date and time) yyyymmddhhmmss.wmv. For example, a video
taken on the 3rd of January 2012 at 10:35:02 would be named 20120103103502.wmv.

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RI Viewer ™ Research Instruments Ltd

RI Viewer Gallery
The RI Viewer Gallery is used to review, store and add comments to images and videos taken using RI
Viewer. The RI Viewer Gallery icon can be found on the tool bar.

RI Viewer Gallery

When images and videos are taken with RI Viewer, they are saved to the pre-configured storage folder.
This is configured from the Settings screen of RI Viewer. The RI Viewer Gallery shows all of the images
and videos in this folder. It allows them to be reviewed and then printed, deleted or assigned to a patient.
Once they have been assigned to a patient, they can also have references and comments added. These
can then be printed alongside the images.

5 The Gallery icon in RI Viewer is used to open RI Viewer Gallery. The first screen displayed is the
Un-Assigned Images screen below.
To return to RI Viewer, close the Gallery using the cross in the top-right corner.

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Research Instruments Ltd RI Viewer™

Un-Assigned Images and Videos

The Un-Assigned Images and Videos screen shows all of the images and videos that are saved in the
default folder as configured in RI Viewer.
• To select an image or video either right-click on it or hold the Ctrl key and left-click. The selected
images are indicated by the coloured border.
• A single left-click will open the image or video in a full-screen view. See “9. Full Screen View”
on page page 26
4

1 2 8 10 3
Patient Details
The Patient Details screen shows the images that have been assigned to the selected patient along with
the patient name, reference and comments that have been entered for each image.
The Delete, Print, Image Selection and Unselect functions all work in the same way.

RI Viewer Gallery Functions :

5 4

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RI Viewer ™ Research Instruments Ltd

1. Delete
2. Assign
3. Unselect
4. Select Patient
5. Return to Unassigned Images and Videos or Patient Details
6. Re-Assign
7. Edit Details
8. Copy
9. Full Screen View
10. Print Preview (Images only)

1. Delete
To delete an image or video, first select it, then press the delete icon. A confirmation screen will
appear, allowing the user to confirm whether the images and videos listed should or should not be
deleted.
5

2. Assign
Assign is used to assign the selected images and videos to a patient using a unique ID number. The
image or video will be moved to the patient folder.

3. Unselect
Unselect will de-select all of the images and videos that have been selected.

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Research Instruments Ltd RI Viewer™

4. Select Patient
Once images or videos have been assigned to a Patient ID, they are no longer shown on the Un-
Assigned screen. To view the images and videos assigned to a patient click the Select Patient button
to show the Select Patient box. Then enter the patient ID number into the box and click the arrow
to go to the Patient Details screen for that patient. See “Patient Details” on page 23

5. Return to Un-Assigned Images and Videos or Patient Details

To return to the Un-Assigned Images and Videos or Patient Details screen click .

6. Re-Assign
5
If the Patient ID was assigned incorrectly click . A pop-up box will appear in which the
correct patient details relating to the image or video can be input. Click OK to save.

7. Edit Details
Edit Details is used to enter a patient name, reference and a comment. These are saved with each
image and are displayed on the Patient Details screen.
If a different patient name, reference or comment has been entered across a selection of images,
the Edit Details screen will display (multiple values) for these fields. Changing this will alter the value
for all of the selected images.

8. Copy
This copies the selected images and videos to the clipboard. These images can then be pasted to a
new location such as a USB drive or into another application such as a word processor.

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RI Viewer ™ Research Instruments Ltd

9. Full Screen View

A single left-click on an image or video will open it in a full-screen view. Delete, Assign, Re-Assign,
Copy and Print can all be actioned from this view. To return to the Un-Assigned Images and Videos
or Patient Details screen click .
5 4 5 4

5
1 2 8 10 1 2 8

10. Print Preview

To preview the image before printing, first select the image. Then press Print. This will open the
Print Preview Functions.

A. Print
B. Print Setting

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Research Instruments Ltd RI Viewer™

A. Print
The Print button will print the selected images with the current settings. See “B. Print Settings”
below.

B. Print Settings
Select the printer, paper size, page range, etc required for printing the selected images. Press
OK to save the changes and return to Print Preview or Cancel to discard your changes.

Advice for Use

All images and videos should eventually be moved out of the Un-Assigned list so that it only contains
newly captured images and videos. If there are any that you do not wish to delete permanently or assign
to an existing patient, then a patient ID of ‘miscellaneous’ or similar can be created to assign them to.
Whenever one or more videos are selected, either in addition to a number of images or by themselves,
the print command is unavailable.

27
Section 6
Saturn™ Laser Systems Intended Uses Research Instruments Ltd

SECTION 6 - SATURN 5 LASER SYSTEM INTENDED USES

Laser Assisted Hatching

The aim of Laser Assisted Hatching (LAH) is to locally weaken the zona pellucida. The specimen is viewed
along the optical axis and the laser creates a trench in the zona pellucida which extends above and
below the apparent hole.
To minimise the risk of damage to blastomeres, users should administer as
few laser pulses as possible at the shortest pulse widths possible to achieve
prescribed zona drilling or thinning effects.
The optimum diameter of the hole is determined by the thickness and/or
hardness of the zona. Larger holes are necessary in thicker zona. Smaller
holes are preferable for thin zona. The hole may fully breach the zona,
whilst some users prefer to ablate only a fraction of the zona thickness, but
across a wider area. This process is commonly referred to as zona thinning.
Circle shows hole Only a single opening should be made in the zona pellucida. Multiple
as viewed through openings or those that are too small may prevent embryo hatching or lead
microscope to abnormal development.
6 The site chosen for the hole should be a section of the zona pellucida where the adjacent perivitelline
space is widest or next to an area of fragmentation. This will minimise possible damage due to heating
of adjacent blastomeres. The Exclusion Zone display can help with this.
To achieve a zona opening of 15µm, select a pulse width which will result in a hole size of 9.3µm to 9.5µm.
A minimum of 4 shots should be applied to breach the inner and outer layers of the zona pellucida. Hole
sizes of up to 10.5µm may be used without affecting blastocyst development rate.
Note: Assisted Hatching is not recommended for routine use in all ART patients.

Embryo Biopsy Procedure

The aim of embryo biopsy is to remove a part of the whole embryo which can then be analysed for
chromosomal or genetic abnormalities.
The Saturn 5 Laser System is only to be used for the uses stated in the Indications for Use section of
this manual.

WARNING - Repeated exposure to laser energy can cause the cells to harden making
extraction of the biopsy cells more difficult to perform. A combination of laser shots,
aspiration and gentle manipulation is recommended to separate the biopsy from the
embryo.

Cleavage Stage Blastomere Biopsy

This biopsy is generally performed at the 6-8 cell stage of embryo development and typically 1 or 2 cells
(blastomeres) are removed for analysis.

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 Section 6
Research Instruments Ltd Saturn™ Laser Systems Intended Uses

A hole should be made around two thirds the size of the cell to be taken (see published papers for exact
dimensions) and care should be taken to drill the zona pellucida where there are no cells close by.
Again, smaller holes will give less heat exposure, so as a guideline we recommend individual hole sizes of
between 5-10µm in diameter. The laser pulse widths required to make these hole sizes will vary a little
from set-up to set-up, but will be anything in the range of between 15-1000µs (see Hole Size Selection,
page 31).
For blastomere biopsy, the resultant hole made in the zona should be approximately 20µm and the
opening should be made in between two blastomeres after the embryo is rotated and the cells selected
for biopsy are positioned. A hole size setting of 9-10µm should be selected and 4-6 shots are usually
sufficient to make an opening of around 20µm.
Firing the laser to make an opening in between two cells means the cells will have less exposure to the
heat generated; therefore, there will be a reduction in the chance of cell lysis and other cells in this
vicinity (above or below) being affected. The embryo should be held at the bottom of the dish when
the laser shots are being applied to maximise laser efficiency.

Trophectoderm/Blastocyst Biopsy

The aim of this biopsy is to take 5-10 trophectoderm (TE) cells from the embryo at blastocyst stage,
without causing damage to the inner cell mass (ICM). Laser assisted hatching (LAH) is performed on 6
day 3 or early day 5 to create a weak point in the zona pellucida through which the trophectoderm cells
can start to herniate.
If creating a hole on day 3, the hole size created should be 15µm as described for Assisted Hatching. At
day 5/6 of embryo development there should be sufficient compaction of the ICM creating herniation
of the TE. If the herniated cells are safely away from the ICM, TE cells can be aspirated with a biopsy
pipette (20-30µm ID).
If creating a hole on day 5/6, an opening of approximately 15-20µm is adequate. In this instance the
opening should be made on the side opposite to the ICM whilst the blastocyst is being held by a holding
pipette and often an immediate collapse of the blastocoelic cavity will result. The biopsy pipette should
be projected towards the collapsed trophectoderm and a few TE cells aspirated and pulled towards
the opening of the zona. To dissociate the TE cells from the remaining embryo, suction from the biopsy
pipette to the TE cells and from the holding pipette to the embryo should continue to be gently and
firmly applied to allow the laser pulses to effectively penetrate and puncture the extended TE layer.
Laser pulses of 0.4-0.8ms can be applied with a maximum of 4 shots at a time to sever the TE cells. This
series of shots can be repeated if needed.
A maximum of 5-10 cells should be aspirated when performing trophectoderm biopsy.

Blastocyst Collapse

Blastocyst collapse is a procedure to remove the blastocoelic fluid of the embryo prior to vitrification
to inhibit ice crystal formation in the cell during the freezing process. The procedure is similar to that
performed for trophectoderm biopsy at day 5/6, that is, it should be performed on expanded blastocysts
and an opening of approximately 15-20µm is adequate. The laser should be fired at the junction between
two trophectoderm cells and should be made on the side opposite to the inner cell mass (ICM). An
immediate collapse of the blastocoelic cavity will result.

29
 Section 7
Laser Ablation Procedure Research Instruments Ltd

SECTION 7 - LASER ABLATION PROCEDURE

1. Select the red laser objective on the microscope and check the objective calibration settings.

WARNING - The embryo may be damaged if objectives other than the red Saturn 5
Laser System objective are used.

2. Check the Laser Target Alignment before each procedure.

3. Check the temperature of the specimen (37°C).
4. Focus at the mid-plane of the embryo.
5. Position the embryo against the surface of the Petri dish using a micromanipulator and holding
pipette to minimise embryo movement.
6. Choose a suitable location for the laser shot.
7. The first attempt to make a hole in the zona pellucida should be made with a short pulse. If the hole
is too small, then use progressively longer pulses until the desired hole size is achieved.

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 Section 7
Research Instruments Ltd Laser Ablation Procedure

Hole Size Selection

For safe and effective treatment, we recommend that pulses used are in the range 15 to 1000µs.
Pulses that are very short may be ineffective and pulses that are too long may damage the embryo. For
this reason, a warning will appear on the Fire button when pulse width is 15µs or below and when the
pulse width is greater or equal to 1000µs.
When the warnings are shown, the laser can still be fired.

Ablation Procedure

Focus on the surface of an empty Petri dish and ensure that the target is correctly aligned to the pilot
laser spot. Place the dish with the specimen on the microscope stage and hold the specimen on the
bottom of the dish with a holding pipette. Check you are using the red Saturn 5 Laser System objective.
To ablate the zona, the focal plane must be at the mid section of the embryo. Refocus the microscope
until the image of the zona is sharp.

Pilot laser brightness: The brightness of the pilot laser can be adjusted by turning the control knob
on the rear panel (see Device Label page 15) to obtain the clearest image in the target alignment
procedure.

The light on the front of the control unit indicates that the control unit is operational. If the unit is
plugged in and the light is not on, contact Research Instruments for assistance.
7
Side view showing embryo on dish surface

Focus here to ablate

Correct Incorrect X

Correct focus - specimen is sharply focussed.

31
 Section 7
Laser Ablation Procedure Research Instruments Ltd

Incorrect focus for drilling.

Using a Saturn 5 Fixed Laser System, move the specimen into

the field of view. Select a short pulse width using the RI Viewer
controls. The different settings do not vary the power of the
laser; they control the length of time that the laser is fired. If
using a Saturn 5 Active Laser System move the target on the
screen by clicking the position required with the mouse button.

Click on the zona pellucida where you want the hole to appear.
Fire the laser by clicking the Fire button in RI Viewer. A small hole
should appear in the zona. If a larger hole is required, increase
the laser pulse time and fire again.
7

To create larger holes and for zona thinning the area should be
ablated using a series of small diameter holes that overlap slightly,
joining to form one larger hole or channel.

Do not attempt to make a large hole with just one shot of the laser. Although this will
not cause damage to the instruments, it could potentially damage the embryo due to the
greater heating effect of the long pulse width.

For further information on the methodology of laser ablation, refer to the many published scientific
papers on the subject, or seek advice from a practitioner who is experienced in the technique.

32
 Section 8
Research Instruments Ltd Saturn 5™ Laser Operation

SECTION 8 - LASER OPERATION

How to Start Up

There is no power button for the Saturn 5. Once the device has been plugged into the power outlet and
the power outlet is switched on then the device is active and can be used.
1. Plug the device into the power outlet.
2. Ensure outlet is switched on.

How to Configure the Laser for a New Procedure

1. Check objective calibration, see page 20.

2. Check laser target alignment, see below.
3. Check hole size calibration, see page 34.

How to Check Laser Target Alignment for Saturn 5 Active Laser System

If the laser has not been aligned before then when you start RI Viewer the alignment procedure will
start automatically.
Laser alignment of the Saturn 5 Active­Laser System can be checked by following these steps.
1. Click the Laser Control icon.
2. Click Laser Settings.
3. Click Align Laser.
4. Ensure there are no embryos in the field of view.
5. Using an empty Petri dish or a slide adjust the focus of the pilot laser to ensure the pilot laser
8
spot is as small as possible. The brightness of the pilot laser can be adjusted.
6. Click Align Laser.
7. The motor will carry out a 7-point alignment at various points on the screen. At each motor
position click the screen at the exact centre of the pilot laser.
8. Click Next to proceed to the next alignment point.
9. When the final alignment point is finished, click on the screen to drive the motor to the selected
point and test the alignment by looking at the distance between the selected point and the
actual position of the pilot laser. If the alignment is acceptable press Finish to close the alignment
window and turn off the pilot laser, or press Align Laser to repeat the process.
10. The laser positioning is accurate to 1μm or better within the area
bounded by the four outer calibration points (see diagram on the
right). For optimum use of the laser, place the section of your
specimen to be ablated within this area. Outside this area the
accuracy is not guaranteed to be better than 3μm.

The diagram (right) represents the 7 calibration points on the screen.

The exact position of the points on the screen will vary depending on
the field of view and on the individual microscope.

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Saturn 5™ Laser Operation Research Instruments Ltd

How to Check Laser Target Alignment for Saturn 5 Fixed Laser System

1. Click the Laser Control icon.

2. Click Laser Settings.
3. Click Align Laser.
4. Ensure embryos have been removed from the field of view.
5. Using an empty Petri dish or a slide adjust the focus of the pilot laser to ensure the pilot laser
spot is as small as possible. The brightness of the pilot laser can be adjusted.
6. Click the centre of the pilot laser.
7. Click Finish.

How to Check Hole Size Calibration

The laser objective must be calibrated correctly for the Hole Size Indicator to work correctly.
The actual size of hole a laser produces may vary depending on the type of Petri dish and media, the
characteristics of the embryo and other factors. For this reason, the Hole Size Indicator may be calibrated.
To calibrate the Hole Size Indicator, you must be using the red laser objective and select the 40X or
20X objective in RI Viewer depending which magnification laser objective is installed. A suitable test
specimen (which will be drilled) should be in the laser target area.

1. Click the Laser Settings button on the Laser Control panel

2. Click the Hole Size Calibration button.
3. Put the laser target on top of the specimen.
4. Fire the laser and ablate an area of the sample specimen.
5. Click the up and down arrows next to Adjust Hole Size to match to the size of the drilled hole.

34
 Section 8
Research Instruments Ltd Saturn 5™ Laser Operation

6. Click the Save Point button when you are happy that the sizes match.
7. Repeat for a number of pulse widths to create a curve on the graph.

Repeated hole size calibration can sometimes introduce incorrect points on the graph.
The graph should normally be a straight line or smooth curve with a positive (increasing)
gradient. If a point leads to a negative gradient then a warning will be displayed on the
chart. This should be corrected as it will imply two different pulse widths for a given hole
size, and may lead to unexpected hole sizes.

How to Remove a Point from the Hole Size Calibration Graph

1. Click the point you wish to remove.
2. Click the Remove button.
The warning will disappear as soon as the negative gradient has been resolved.

Laser Target

RI Viewer displays a laser target on the image. This indicates where the laser beam is focused, and thus
where the hole will appear.
Note: To use the laser system, the specimen must be viewed with the red laser objective.
The target will only be shown when the system is in laser mode.
The appearance and size of the laser target can be modified. The Target Appearance Setting is displayed
in the Laser Settings panel. You can change its appearance by adjusting the sliders. This is also where
the size of the laser Exclusion Zone can be set.
8
Hole Size Indicator

The circle that is displayed indicates the estimated size of the hole that will be created when the laser
is fired. Actual hole sizes may vary due to natural differences between specimens.
The Hole Size Indicator can be turned on or off from the Target Appearance panel on the Laser Settings
panel.

Exclusion Zone

The laser generates heat which has the potential to damage critical cells. The Exclusion Zone provides
a measuring tool to show whether critical cells are close to the laser ablation area and therefore may
be affected by the heat. The target point should be as far away from these critical cells as is possible to
avoid unnecessary damage and it is ultimately the responsibility of the user to define a safe distance.
The default exclusion zone setting is 5μm. This can be adjusted via the Target Appearance panel using
the slider or input box.

35
 Section 8
Saturn 5™ Laser Operation Research Instruments Ltd

How to Adjust Hole Size/Pulse Width

1. Hold the left mouse button down and drag until the desired size is reached (Fixed laser systems only).
2. For Active systems the option to click and drag can be turned off in the General Settings.
3. Click and drag the slider on the Laser Control panel.
4. Fine adjustment can be made using the up down keys.

Preset Pulse Widths

Preset pulse widths are 0.350ms, 0.400ms and 0.450ms and

these preset values can be changed using RI Viewer.
Choose the preset by clicking the + or - buttons.
To change a preset, select the preset, set the desired value using
the slider, and click the Save button.
Hole sizes can also be chosen by clicking on the screen and
dragging a hole of the size you need. The pulse width will be
calculated automatically to create the size of hole required.

How to Fire the Laser (Single Pulse)

Find the sample under the microscope using an objective with wide field of view (for example the 4x

8
objective).
1. Hold the sample with a holding pipette at the bottom of the dish.
2. Switch to the laser objective and focus on the sample.
3. Click the Laser Control icon on the tool bar.
4.a Fixed System - position the sample such that the desired hole location is under the target.
4.b Active System - position the sample in the field of view. Click on the desired position of the hole.
5. Click the Fire button. The control unit will beep to confirm that the laser has fired
In some installations, the field of view is larger than the range of movement of the laser. If the cursor is
moved to a position on the screen where the laser cannot reach, the unreachable area will be highlighted.
The target cannot be placed in this area.

36
 Section 8
Research Instruments Ltd Saturn 5™ Laser Operation

Biopsy Mode

Biopsy Mode is available with the Saturn 5 Active Laser System only and can be used for assisted hatching
and embryo biopsy procedures. It allows the user to deliver a series of 4-6 shots along a predetermined
line automatically and has no behavioral differences to a succession of single shots; that is, it is as safe
as single shot mode. This predetermined line can be straight or curved.
When using this mode care must be taken
• not to draw a line where you do not want a hole to be drilled
• not to move the sample while firing the laser
• to check the laser settings and alignment prior to firing
• to fire in between two cells so that the cells are less exposed to the heat generated and to reduce
the chance of cell lysis and other cells around this vicinity (above or below) being also affected by
the heat.
• gulations
How to Enable Biopsy Mode

1. Click the General Settings icon on the tool bar.

2. Tick Enable Biopsy Mode. (This option is available only with Saturn 5 Active Laser System).

How to Fire the Laser (Biopsy Mode)

1. Switch to the laser objective.

2. Focus on the sample.
3. Click the Laser Control Icon on the tool bar.
8
4. Check the sample is just on the bottom of the dish.
5. From the Laser Control Panel, click Biopsy. You will be taken to the Laser Biopsy panel.
6. Click where you want the first hole to be. The line will follow your cursor.
7. Click where you want the last hole to be. The holes to be drilled are overlaid on the image.
8. The size and number of holes can be changed by moving the two sliders on the panel.
9. The line can be lengthened or shortened by dragging the line end.
10. A point in the middle of the line can be dragged to create a curved line.
11. Press Start Firing to begin the firing procedure. The laser will then drill each hole in sequence.

If Biopsy Mode needs to be stopped at any stage press Stop.

How to Shut Down

1. Close RI Viewer software.

2. Unplug the device from the power outlet.

37
 Section 9
Troubleshooting for Saturn 5™ Laser System Research Instruments Ltd

SECTION 9 - TROUBLESHOOTING FOR SATURN 5 LASER SYSTEM

Problem Possible Cause Solution

Check the power supply is
No power input plugged in to the mains and
No lights on control unit switched on
Use only the power supply
Incorrect power supply
provided
Make sure camera is
Camera not connected connected to PC and to power
supply if appropriate
Check brightness/contrast
No video image
Incorrect camera settings settings (section How to view
live image)
Microscope camera port not
Select camera port
selected
Only use the red Saturn 5
Wrong objective used
Laser System objective
Target misaligned Check alignment
Check port selector is in
Port selector misaligned
correct position*
Laser having no effect
Dirt on fibre optic Service required
Check the embryo is touching
Embryo above dish surface
the dish surface
Dirt on fibre optic Service required
Straighten fibre optic patch
Kinked fibre optic lead - minimum bend radius
50mm
Hole size smaller than expected
9 Embryo too cold
Check temperature should be
37°C
Dirt/oil on objective Clean objective
Excessive pulse width Choose smaller hole size
Hole size larger than expected Check calibration. Check for
Hole Size Indicator not calibrated
negative gradient
Check port selector is in
Port selector misaligned
correct position*
Laser position inaccurate
Calibrate each time unit is
Calibration not done
switched on

*Some microscope port selectors do not return to exactly the same position when moved. Check the
target alignment each time the port selector is moved.

38
 Section 10
Research Instruments Ltd Care and Maintenance

SECTION 10 - CARE AND MAINTENANCE

Cleaning

We recommend that a non PVC dust cover is placed over the microscope when not in use. Plasticisers
commonly used in PVC are toxic to embryos.
The control unit case should be cleaned with a cloth moistened with isopropyl alcohol or mild detergent
solution only. If any liquids are spilt over the control unit switch off immediately and remove the power
connector. Clean the spill and ensure that the unit is completely dry before switching on. If it is suspected
that any liquids have gone inside the case contact RI for advice before switching on.
Routine maintenance simply involves ensuring that all optical components are kept clean. The lens on
the end of the Saturn 5 Laser System objective should be cleaned occasionally by wiping gently with a
dry lens cloth.
Every six months the collimator module should be removed and the dichroic mirror cleaned with a dry
lens cloth. This should be done by RI or an appointed representative as the laser alignment must be
checked and readjusted after removing the collimator module.
For further advice on microscope cleaning, please contact RI or your microscope supplier.

Servicing

We recommend that the system undergoes a routine service at least every twelve months.
This can normally be carried out by your distributor.

Regular servicing by an RI authorised technician will help to ensure that your system performs at its
best. We recommend a minimum of one annual inspection and service. However, this may need to
be more frequent if systems are heavily used. Contact your distributor or RI’s service team directly
to arrange servicing. Where necessary, RI will provide all technical information required to assist in
resolving problems.
For all maintenance requirements, contact your distributor or RI’s service team directly.
In the event that you have a problem with RI instruments, first look at the Troubleshooting section. If
you require any further help, contact your distributor or RI’s service team direct. We will try to resolve
the problem as quickly as possible.
No user serviceable parts. 10
Disposal of Goods

If any electronic component is no longer serviceable, it must be sent back to RI to be destroyed

in an environmentally safe way. Do not dispose of with ‘normal’ waste.

39
Section 11
Warranty Information and Limits on Liability Research Instruments Ltd

SECTION 11 - WARRANTY INFORMATION AND LIMITS ON LIABILITY

Research Instruments Limited (RI) warrants that this item will be free from defects in materials and
workmanship for one year from the date of installation. If RI determines that the product fails to
conform to that warranty during the one-year period, RI will repair or replace the product, at RI’s
discretion, free of charge.

To return the product to RI, a customer must comply with RI’s Returned Goods Policy described in
this manual and the warranty requires the customer to return the product to RI in accordance with
the RI Returns Instruction. RI will return products (that it repaired or replaced under warranty) to the
same customer who returned those products, at RI’s expense F.O.B. the customer’s facility. Under all
other circumstances, RI will return products to the same customer who returned those products at the
customer’s expense.

RI’s warranties do not cover damage caused by misuse, improper care, improper use of chemicals or
cleaning methods, loss, theft, use of non-authorized parts servicing by non-authorized personnel or
negligent or intentional conduct on the part of the owner or user of the product, nor do they cover
normal wear and tear or general maintenance. Any modifications or changes to a product will void that
product’s warranty. RI’s warranties do not apply to any single- or limited-use, disposable or consumable
components or items.

RI is not responsible for, and the owner and operator of the product shall defend, indemnify and
hold harmless RI from and against, all claims, damages, and other losses resulting from the improper
servicing, maintenance, repair use or operation of the product or the owner or operator’s negligence
or willful misconduct, and use of inadequate packing and packaging when returning product for repair.

The above warranties are in lieu of, and RI hereby disclaims, all other warranties, express or implied,
written or oral, with respect to RI’s products, including the warranties of merchantability and fitness for
a particular purpose. No terms, conditions, understandings or agreements that purport to modify the
above warranties or that make any additional warranties for any RI’s product shall have any legal effect
unless made in writing and signed by an authorized RI corporate officer.

RI shall not under any circumstances be liable for lost profits, damages from loss of use or lost data, or
indirect, special, incidental or consequential damages under its warranties or otherwise for any claim
related to RI’s products, even if RI has been advised, knew or should have known of the possibility

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of such damages. RI’s liability with respect to a product covered by a warranty or otherwise shall be
limited in all circumstances to the purchase price of that product.

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 Section 12
Research Instruments Ltd Repairs and Returns Procedures

SECTION 12 - RETURNING PRODUCT TO RI FOR REPAIR

Please refer to the ‘Troubleshooting’ section in this manual before returning product to RI. If you
continue to have a problem with your device, please follow these instructions:
Returned Goods Policy
Goods will be accepted for return for the following reasons:
If shipment was made without the customer’s authorization or order
If incorrect items were shipped
If defective items were shipped
If defective goods are covered by the standard warranty

To return product, you must contact Customer Service for a Returned Merchandise Authorization
(RMA) number. Items will not be accepted without an RMA number. Please have the following
information:
• Reason you wish to return the goods
• Quantity, description, part number, serial number of the goods
• Date of receipt of order
• Customer’s purchase order and the CooperSurgical or Origio invoice number

All used products must be cleaned and sterilized prior to shipment. A signed decontamination declaration
may be required.
All products should be carefully and adequately packed, preferably in original packaging. Replacement
items or additional repairs will be invoiced.
All packaging should be clearly labeled with the RMA number and statement “Urgent – Returned Items
for Repair”.
Return Address: Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK
Shipments must be sent prepaid by the customer and insured for their full value during shipping. Freight
collect shipments will not be accepted, and goods will be returned to sender.
If Customer intends to return equipment ordered in error, the following restocking charges and terms
will apply:
• 25 percent within 60 days from date of shipment
• Goods must be returned unused, in the original carton, and in marketable condition
• Refurbishing and replacement charges will be added to the restocking charges for damaged or
missing items
• No return after 60 days
• No refund on sterile, single-use disposable products
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Section 12
Returning Product to RI for Repair Research Instruments Ltd

Customer Service Contact details:

Tel: +45 46 79 02 02
Fax: +45 46 79 03 02
E-mail: [email protected]
coopersurgical.com

US only customers contact details:

Tel: 800-243-2974
Fax: 800-262-0105
coopersurgical.com

Obligation to Inform

In compliance with the European Medical Device Directive 93/42/EEC as amended, it is your duty to
inform RI and your competent authority if you believe this device has, or may have, caused or contributed
to the death of a patient or user or to a serious deterioration in their state of health.

Feedback

Thank you for purchasing an RI product. To help RI develop the best tools for ART, we rely on customer
feedback. If you have any suggestions for how we can improve our products or the information we provide
with them, please send them to Customer Service. Your feedback will help us develop the product and
supporting materials to meet your future needs.
Thank you.

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