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CooperSurgical RI SATURN 5 User Manual

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User Manual
S A T U R N 5 L A S E R S Y S T E M S
™
RESEARCH INSTRUMENTS LTD
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com
www.research-instruments.com
Document 6-47-500UM, Issue 11, 03
May 2016, DRF 3437
rd

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  • Page 1 User Manual S A T U R N 5 L A S E R S Y S T E M S ™ RESEARCH INSTRUMENTS LTD Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com www.research-instruments.com Document 6-47-500UM, Issue 11, 03 May 2016, DRF 3437...

  • 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 WARNINGS Precautions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions (IEC 60601-1-2) Guidance and Manufacturer’s Declaration —...
  • Page 3 SECTION 6 - SATURN 5 LASER SYSTEM INTENDED USES Laser Assisted Hatching Embryo Biopsy procedure Cleavage Stage Blastomere Biopsy Trophectoderm /Blastocyst Biopsy Blastocyst Collapse SECTION 7 - LASER ABLATION PROCEDURE Hole Size Selection Ablation Procedure SECTION 8 - LASER OPERATION How to Startup How to Configure the Laser for a New Procedure How to Check Laser Target Alignment for Saturn 5 Active Laser System...

  • Page 4: Section 1 - Preface

    Section 1 Preface Research Instruments Ltd 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.

  • Page 5: Section 2 - Introduction To The Saturn 5 Laser System

    Section 2 Research Instruments Ltd Introduction to Saturn 5™ Laser Systems 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 Indication for Use - USA Customers Only For use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to facilitate...

  • Page 6: Installation

    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 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.

  • Page 7: Section 3 - Safety Warnings

    Section 3 Research Instruments Ltd Saturn 5 Laser Systems Safety Warnings ™ SECTION 3 - SAFETY WARNINGS Laser radiation is present within the control unit, the fibre optic patch lead and through the microscope to output at the objective. The Saturn 5 Laser System has been designed to ensure that emission 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 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.

  • Page 9: Precautions

    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. •...

  • Page 10: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    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.”...
  • Page 11 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...

  • Page 12: Safety/Information Symbols

    Section 3 Saturn 5 Laser Systems Safety Warnings Research Instruments Ltd ™ Safety/Information Symbols Symbol Meaning Indicates instruction for disposal of goods. 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 0120 notified body No.0120, SGS, UK Ltd.

  • Page 13: Section 4 - Product Overview

    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. 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 14: Saturn 5 Laser System Component Part Numbers

    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...

  • 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 5-45-580 Collimator module for IMT2 5-45-411...

  • 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 length 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™ Research Instruments Ltd 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

    Section 5 RI Viewer ™ Research Instruments Ltd How to View Live Images A camera will need to be connected to the PC running RI Viewer and the drivers installed correctly to view live images within RI Viewer. The dongle must also be fitted to a USB port. RI Viewer software will automatically recognise both analogue and compatible digital camera devices connected to the PC.

  • Page 19: Camera Flipping

    Section 5 RI Viewer™ Research Instruments Ltd 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 those microscope set ups where the camera may be required to be inverted.

  • Page 20: How To Configure The Foot Pedal/Keyboard

    Section 5 RI Viewer ™ Research Instruments Ltd 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.

  • 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. The ends of the line can be dragged to change the measurement.

  • Page 22: Ri Viewer Gallery

    Section 5 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.
  • Page 23 Section 5 RI Viewer™ Research Instruments Ltd 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: Advice For Use

    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.

  • Page 28: Section 6 - Saturn 5 Laser System Intended Uses

    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.

  • 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 radiation, 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 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 is used.

  • Page 31: Hole Size Selection

    Section 7 Laser Ablation Procedure Research Instruments Ltd 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.
  • Page 32 Section 7 Laser Ablation Procedure Research Instruments Ltd Using a Saturn 5 Fixed Laser System, move the specimen into the field of view. Select a short pulse length 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.

  • Page 33: Section 8 - Laser Operation

    Section 8 Saturn 5™ Laser Operation Research Instruments Ltd 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.

  • Page 34: How To Check Hole Size Calibration

    Section 8 Saturn 5™ Laser Operation Research Instruments Ltd 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.

  • Page 35: Laser Target

    Section 8 Saturn 5™ Laser Operation Research Instruments Ltd 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.

  • Page 36: How To Fire The Laser (Single Pulse)

    Section 8 Saturn 5™ Laser Operation Research Instruments Ltd How to Fire the Laser (Single Pulse) Find the sample under the microscope using an objective with wide field of view (eg 4x objective). 1. Hold the sample with a holding pipette at the bottom of the dish. 2.

  • Page 37: How To Fire The Laser (Biopsy Mode)

    Section 8 Saturn 5™ Laser Operation Research Instruments Ltd 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. 4. Check the sample is just on the bottom of the dish. 5.

  • 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 No lights on control unit Use only the power supply Incorrect power supply...

  • Page 39: Section 10 - Care And Maintenance

    Section 10 Care and Maintenance Research Instruments Ltd 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 only.

  • Page 40: Section 11 - Repairs And Returns Procedures

    Section 11 Repairs and Returns Procedures Research Instruments Ltd SECTION 11 - REPAIRS AND RETURNS PROCEDURES RI Repairs System In the event that you have a problem with a RI instrument, please follow the procedure below to ensure prompt attention. 1.

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