RI SATURN 5 User manual

User Manual
SATURN 5 LASER SYSTEMS
™
only
0120
0120
[phone] | customer[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

CONTENTS
 
 
Intended Use 5
Indicaon for Use - USA Customers Only 5
Applicable Part Numbers 5
Microscope Compability 5
Installaon 6
 
Cauons and Warnings 7
Precauons 9
Guidance and Manufacturer’s Declaraon – Electromagnec Emissions (IEC 60601-1-2) 9
Guidance and Manufacturer’s Declaraon — Electromagnec Immunity 10
Safety and Informaon Symbols 12
 
System Components 13
Saturn 5 Laser System Component Part Numbers 14
Saturn 5 Acve Laser System Mirror Module Part Numbers 14
Saturn 5 Laser System Collimator Module Part Numbers 15
Hardware Overview 15
Laser Specicaons 16
Objecve Specicaons 16
Saturn Acve Specicaons 16
Electrical Specicaons 16
Mains Adaptor for Control Unit and Motor Module 16
Dimensions 16
Operang Condions 16
Storage/Transport Condions 16
 
Introducon 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 Sengs 19
Objecves 19
How to Select Objecves 19
How to Add Objecves 19

How to Remove Objecves 19
How to Check Objecve Calibraon 19
How to Congure 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
 
Laser Assisted Hatching 28
Embryo Biopsy Procedure 28
Cleavage Stage Blastomere Biopsy 28
Trophectoderm/Blastocyst Biopsy 29
Blastocyst Collapse 29
 
Hole Size Selecon 31
Ablaon Procedure 31
 
How to Start Up 33
How to Congure the Laser for a New Procedure 33
How to Check Laser Target Alignment for Saturn 5 Acve Laser System 33
How to Check Laser Target Alignment for Saturn 5 Fixed Laser System 34
How to Check Hole Size Calibraon 34
How to Remove a Point from the Hole Size Calibraon 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
 
 
Cleaning 39
Servicing 39
Disposal of Goods 39
 
 
Obligaon to Inform 42
Feedback 42

Secon 1
Preface
1
4
Research Instruments Ltd

Thank you for choosing the Saturn 5 Laser System.
This manual provides all necessary informaon to use the Research Instruments Ltd Saturn 5 Laser
System. The system should be operated by trained personnel only. All secons of this manual should
be read and understood fully before any operaon of the system. Please see the Intended Use for more
informaon.
If the operator is unsure of any of the informaon contained in this manual, they should contact
Research Instruments or an appointed representave before aempng 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
consequenal 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 wrien consent of Research Instruments Ltd.
Saturn™ and RI Viewer™ are trademarks of Research instruments Ltd. All other brand names are
trademarks of their respecve owners.
The informaon in this manual is current at the me of publicaon. RI is constantly updang its
products, and, therefore, reserves the right to introduce changes in design, equipment and technical
features at any me. The latest version of the User Manual as well as RI Viewer soware can be
downloaded from soware.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.

Secon 1
1
Preface

Research Instruments Ltd
6-47-500 - Saturn 5 Acve Laser System
6-47-501 - Saturn 5 Fixed Laser System

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
Applicable indicaons for use are subject to the regulaons of the country into which the device is sold.
only
0120
0120


Intended Use

For use in assisted reproducon procedures to ablate or thin the zona pellucida of an embryo to
facilitate assisted hatching or recovery of cells for pre-implantaon genec diagnosis (blastomeres).
The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-
implantaon diagnosis procedures, and blastocyst collapse prior to vitricaon procedures.
 Federal law restricts this device to sale by or on the order of a physician or a praconer
trained and cered in its use
The Saturn Laser System is intended to ablate a User defined section of a gamete or embryo
within ART.

Secon 2
Introducon to Saturn 5™ Laser Systems
2
6
Research Instruments Ltd

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 soware. We recommend PC security features such as an-virus
soware/rewall be installed consistent with the facility’s IT policy and that each user of the system
has a password protected user prole assigned to the PC in order to prevent unauthorised access.
Installaon of the Saturn 5 Laser System should be carried out by a Research Instruments technician
or other RI-authorised personnel. Incorrect installaon could result in reduced power output, laser
misalignment or laser malfuncon. Relocaon of this system should be treated as a re-installaon and
should, therefore, be carried out by authorised personnel.
Please note that installaon and servicing is covered separately in the Saturn 5 Laser System Installaon
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
hp://soware.research-instruments.com
Once installed, the RI Viewer applicaon can be started by double clicking the RI Viewer icon on the
desktop.

Secon 3
3
Saturn™

Research Instruments Ltd


Laser radiaon is present within the control unit, the bre opc patch lead and through the micro-
scope to output at the objecve. The Saturn 5 Laser System has been designed to ensure that emis-
sion of laser radiaon at any point is within the limits spulated by internaonal safety standards,
IEC 60825-1:2014, and US 21CFR1040.10 for unprotected viewing (Class 1). As an extra precauon, an
infrared blocking lter has been incorporated into the opcal path leading to the eyepieces to reduce
laser emission by a further 99%.
For a descripon of controls and for the locaon of laser aperture on control unit, see Secon 4 -
Hardware Overview.
 disassemble or modify any part of the Saturn 5 Laser System, or substute any
component for any other. Doing so may result in exposure to dangerous levels of laser
radiaon. This voids the warranty and/or service contract.
 operate the laser unless it is properly mounted to a microscope.
 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 posioned 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.
 To avoid the risk of electric shock, this equipment must only be connected to
a mains supply with protecve earth.
 Not to be used in a paent environment
CAUTION Hazardous radiaon exposure may occur through the use of controls, execung
adjustments or the performance of procedures other than those specied herein. Servicing
and adjustment other than that specied in this manual should only be carried out by RI
or RI authorised agents.
This indicates cauonary text which should be followed to avoid injury to users or damage
to samples.
The system should be operated by qualied and trained personnel only.

Secon 3
Saturn™ 5 Laser Systems Safety Warnings
3

Research Instruments Ltd
The embryo may be damaged if objecves other than the red Saturn 5 Laser
System objecve are used.
Do not modify this equipment without authorisaon of the manufacturer.
Where an ITO glass heated stage is ed, do not re the laser with the
microscope focussed into the ITO glass surface as this may damage the ITO coang.
Thermal lensing is a defocusing of the laser beam caused by changes to
the refracve 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 eect on
the drilling properes, this eect may become a problem for higher beam energies. To
eliminate any signicant eects from thermal lensing, we recommend that the pulse
width be kept below 1000μs for clinical Laser Assisted Hatching (LAH) zona drilling.
Only a single opening should be made in the zona pellucida. Mulple openings
or those that are too small may prevent embryo hatching or lead to abnormal development.
Do not operate the pilot laser with an embryo in the eld of view. Exposure
to the pilot laser may damage the embryo.
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.
Before performing any procedure, the pilot laser must be used to check
the alignment of the Acve posioning system. The system must be re-aligned when
necessary. See Secon 8 How to Check Laser Target Alignment.

Secon 3
3
Saturn™
9
Research Instruments Ltd
Emissions test  

RF emissions
CISPR 11
Group 1
The Saturn 5 Laser System uses
RF energy only for its internal
funcon. Therefore, its RF
emissions are very low and are
not likely to cause
any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Saturn 5 Laser System
is suitable for use in all
establishments, including
domesc establishments and
those directly connected to
the public low-voltage power
supply network that supplies
buildings used for domesc
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuaons/icker
emissions Complies

The Saturn 5 Laser System is intended for use in the electromagnec environment specied below. The
customer or the user of the Saturn 5 Laser System should assure that it is used in such an environment.
*Kanyo, K., Konc, J. “A follow-up study of children born aer diode laser assisted hatching.” European
Journal of Obstetrics and Gynaecology. 110: 176-180 (2003).

• 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 eect.
• Direct the laser beam toward a secon of the zona pellucida where the adjacent perivitelline space
is widest or next to an area of fragmentaon.
• A holding pipee should be used during laser treatment to minimise the risk of embryo movement.
• Small openings in the zona pellucida may lead to embryo constricon and abnormal development.
• 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 malformaons, chromosomal aberraons or minor congenital malformaons between
the LAH treated group and all deliveries at their hospital.
• The device is not aected by and does not present any reciprocal interference to the microscope.
• During normal use there is no contact with paent/sample.

Secon 3
Saturn™ 5 Laser Systems Safety Warnings
3

Research Instruments Ltd

Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
“This is a class A product. In a domesc environment this product may cause radio interference in
which case the user may be required to take adequate measures.”

The Saturn 5 Laser System is intended for use in the electromagnec environment specied below. The
customer or the user of the Saturn 5 Laser System should ensure that it is used in such an environment.
 

 

Electrostac
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic le. If oors are
covered with synthec material,
the relave humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output Lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 1 kV dierenal
Mode
± 2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips, short
interrupons and
voltage variaons
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT ) for
0.5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5 % UT
(>95 % dip in UT) for
5s
<5 % UT
(>95 % dip in UT) for
0.5 cycle
40 % UT
(60 % dip in UT) for
5 cycles
70 % UT
(30 % dip in UT) for
25 cycles
<5 % UT
(>95 % dip in UT)
for 5s
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the Saturn 5 Laser
System requires connued
operaon during power mains
interrupons, it is recommended
that the Saturn 5 Laser System be
powered from an uninterrupble
power supply or a baery.
Power frequency
(50/60 Hz)
magnec eld
IEC 61000-4-8
3 A/m 0.3 A/m The power frequency magnec
eld should be measured in the
intended installaon locaon to
assure that it is suciently low.
UT is the a.c. mains voltage prior to applicaon of the test level.