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Summary of Contents for RI SATURN 5
- Page 1 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 | customerservice@origio.com | coopersurgical.com Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK 0120 only 0120...
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Page 2: Table Of Contents
CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO THE SATURN 5 LASER SYSTEM Intended Use Indication for Use - USA Customers Only Applicable Part Numbers Microscope Compatibility Installation SECTION 3 - SAFETY Cautions and Warnings Precautions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions (IEC 60601-1-2) Guidance and Manufacturer’s Declaration —... - Page 3 How to Start Up How to Configure the Laser for a New Procedure How to Check Laser Target Alignment for Saturn 5 Active Laser System How to Check Laser Target Alignment for Saturn 5 Fixed Laser System How to Check Hole Size Calibration...
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Page 4: Section 1 - Preface
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. -
Page 5: Section 2 - Introduction To The Saturn 5 Laser System
Section 1 Research Instruments Ltd Preface SECTION 2 - INTRODUCTION TO THE SATURN 5 LASER SYSTEM 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). -
Page 6: Installation
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 software/firewall be installed consistent with the facility’s IT policy and that each user of the system... -
Page 7: Section 3 - Safety
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- 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). - Page 8 WARNING The embryo may be damaged if objectives other than the red Saturn 5 Laser System objective are used.
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Page 9: Precautions
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... -
Page 10: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity 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... - Page 11 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.
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Page 12: Safety And Information Symbols
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... -
Page 13: Section 4 - Product Overview
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. -
Page 14: Saturn 5 Laser System Component Part Numbers
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* Saturn 5 Active Laser System Mirror Module Part Numbers... -
Page 15: Saturn 5 Laser System Collimator Module Part Numbers
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... -
Page 16: Laser Specifications
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... -
Page 17: Section 5 - Ri Viewer
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. -
Page 18: How To Zoom & Pan The Image
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... -
Page 19: Changing Camera Settings
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. -
Page 20: How To Configure The Foot Pedal/Keyboard
3. Place an object of known dimensions (a stage micrometer is supplied with each system for this purpose) in the field of 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. -
Page 21: How To Perform Measurements
Section 5 RI Viewer™ Research Instruments Ltd 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. -
Page 22: Ri Viewer Gallery
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. - Page 23 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.
- Page 24 Section 5 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.
- Page 25 Section 5 RI Viewer™ Research Instruments Ltd 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.
- Page 26 Section 5 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 10.
- Page 27 Section 5 RI Viewer™ Research Instruments Ltd 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.
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Page 28: Section 6 - Saturn 5 Laser System Intended Uses
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. -
Page 29: Trophectoderm/Blastocyst Biopsy
Section 6 Saturn Laser Systems Intended Uses Research Instruments Ltd ™ 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. -
Page 30: Section 7 - Laser Ablation Procedure
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. -
Page 31: Hole Size Selection
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. - Page 32 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.
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Page 33: Section 8 - 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. -
Page 34: How To Check Laser Target Alignment For Saturn 5 Fixed Laser System
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. -
Page 35: How To Remove A Point From The Hole Size Calibration Graph
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. -
Page 36: How To Adjust Hole Size/Pulse Width
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. -
Page 37: Biopsy Mode
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;... -
Page 38: Section 9 - Troubleshooting For Saturn 5 Laser System
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 switched on... -
Page 39: Section 10 - Care And Maintenance
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. -
Page 40: Section 11 - Warranty Information And Limits On Liability
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... -
Page 41: Section 12 - Returning Product To Ri For Repair
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:... -
Page 42: Obligation To Inform
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.
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