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RI SATURN 5 User Manual

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User Manual
SATURN 5 LASER SYSTEMS
only
0120
0120
+45 46 79 02 02 | customerservice@origio.com | coopersurgical.com
Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-47-500UM(15) | DRF 4915 | 25th June 2019

Table of Contents

Questions and Answers:

RI SATURN 5 Specifications

General IconGeneral
BrandRI
ModelSATURN 5
CategoryMeasuring Instruments
LanguageEnglish

Summary

SECTION 1 - PREFACE

SECTION 2 - INTRODUCTION TO THE SATURN 5 LASER SYSTEM

Intended Use

Describes the intended purpose and application of the Saturn 5 Laser System within ART procedures.

Indication for Use - USA Customers Only

Outlines specific indications for use for customers located in the USA, focusing on zona pellucida ablation and biopsy.

Applicable Part Numbers

Lists the specific part numbers for the Saturn 5 Laser System components and accessories.

Microscope Compatibility

Details the compatible microscope models for use with the Saturn 5 Laser System.

Installation

Provides instructions and considerations for installing the Saturn 5 Laser System, including PC and software setup.

SECTION 3 - SAFETY

Cautions and Warnings

Highlights important safety precautions and warnings related to laser radiation and system operation.

Precautions

Lists specific precautions to minimize risks during laser procedures, such as pulse width and sample positioning.

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

Details electromagnetic emissions compliance and environmental guidance for the Saturn 5 Laser System.

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

Outlines electromagnetic immunity guidelines and compliance levels for the system in various environments.

Safety and Information Symbols

Explains the meaning of various safety and informational symbols used throughout the manual and on the device.

SECTION 4 - PRODUCT OVERVIEW

System Components

Identifies and illustrates the main physical components of the Saturn 5 Laser System, including control unit and modules.

Saturn 5 Laser System Component Part Numbers

Lists the part numbers for the general Saturn 5 Laser System components, such as control units and objectives.

Saturn 5 Active Laser System Mirror Module Part Numbers

Lists part numbers for mirror modules specific to the Saturn 5 Active Laser System for various microscope models.

Saturn 5 Laser System Collimator Module Part Numbers

Lists part numbers for the collimator modules for various compatible microscope types.

Hardware Overview

Provides a high-level overview of the system's hardware components and their physical arrangement.

Laser Specifications

Details the technical specifications for the ablation and pilot lasers, including wavelength and power.

Objective Specifications

Provides specifications for the laser objectives, including magnification, NA, and working distance.

Saturn Active Specifications

Outlines specific performance specifications for the Saturn 5 Active Laser System, such as range of movement.

Electrical Specifications

Lists the electrical input/output specifications for the system's mains adaptor and control unit.

Dimensions

Specifies the physical dimensions and weight of the control unit.

Operating Conditions

Details the recommended operating temperature, humidity, and pressure for the system.

Storage/Transport Conditions

Specifies the recommended conditions for storing and transporting the system to maintain its integrity.

SECTION 5 - RI VIEWER

Introduction

Introduces the RI Viewer software and its role in interacting with the Saturn 5 Laser System for ART laboratory use.

User Interface Icons

Explains the meaning of various icons used within the RI Viewer interface for controlling functions.

How to Zoom & Pan the Image

Describes methods for adjusting zoom and panning within the RI Viewer image display for detailed viewing.

How to Set the Preset Zoom

Details how to configure preset zoom levels for camera views in RI Viewer for quick access.

How to Select Cameras

Explains the process for selecting and switching between connected cameras in RI Viewer for live imaging.

Camera Flipping

Covers how to flip camera images horizontally or vertically for correct display, often set during installation.

Changing Camera Settings

Describes how to adjust camera settings like frame rate and other video source options within RI Viewer.

Objectives

Explains the importance of matching microscope objectives to RI Viewer settings for accurate measurements.

How to Select Objectives

Guides the user on selecting the correct objective magnification within RI Viewer for optimal imaging.

How to Add Objectives

Details the procedure for adding custom objective calibrations in RI Viewer for accurate measurements.

How to Remove Objectives

Explains how to remove existing objective calibrations from RI Viewer when no longer needed.

How to Check Objective Calibration

Guides the user on verifying the accuracy of objective calibrations in RI Viewer using a stage micrometer.

How to Configure the Foot Pedal/Keyboard

Details how to assign shortcuts to the foot pedal or keyboard for software functions in RI Viewer.

How to Perform Measurements

Explains how to use the measurement tools within RI Viewer to quantify image features like length and area.

How to Take a Picture

Describes the process of capturing still images using the RI Viewer software, including file naming conventions.

How to Record Video

Guides the user on how to record video clips of samples via the RI Viewer software, including recording limits.

RI Viewer Gallery

Introduces the RI Viewer Gallery for managing, reviewing, and commenting on captured media like images and videos.

Un-Assigned Images and Videos

Describes the screen for viewing and managing unassigned images and videos before patient assignment.

Patient Details

Explains the Patient Details screen for viewing media assigned to specific patients, including references and comments.

RI Viewer Gallery Functions

Details the various functions available within the RI Viewer Gallery interface for media management.

SECTION 6 - SATURN 5 LASER SYSTEM INTENDED USES

Laser Assisted Hatching

Describes the use of the laser system for Laser Assisted Hatching (LAH) procedures to weaken the zona pellucida.

Embryo Biopsy Procedure

Outlines the use of the laser system for embryo biopsy procedures to remove cells for genetic analysis.

Cleavage Stage Blastomere Biopsy

Details the procedure for blastomere biopsy at the cleavage stage of embryo development for analysis.

Trophectoderm/Blastocyst Biopsy

Explains the process of trophectoderm/blastocyst biopsy for genetic analysis on blastocyst stage embryos.

Blastocyst Collapse

Describes the use of the laser system for inducing blastocyst collapse prior to vitrification procedures.

SECTION 7 - LASER ABLATION PROCEDURE

Hole Size Selection

Discusses factors influencing hole size selection and recommended pulse ranges for safe and effective zona drilling.

Ablation Procedure

Provides a step-by-step guide for performing laser ablation on specimens, including focus and alignment.

SECTION 8 - LASER OPERATION

How to Start Up

Guides the user on powering up and activating the Saturn 5 Laser System by connecting to power.

How to Configure the Laser for a New Procedure

Outlines necessary checks and configurations, like objective calibration and target alignment, before starting a procedure.

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

Provides a detailed procedure for aligning the laser target on the Saturn 5 Active Laser System via RI Viewer.

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

Details the steps for checking laser target alignment on the Saturn 5 Fixed Laser System using RI Viewer.

How to Check Hole Size Calibration

Explains how to calibrate the Hole Size Indicator in RI Viewer for accurate laser hole size predictions.

How to Remove a Point from the Hole Size Calibration Graph

Guides on removing incorrect data points from the hole size calibration graph to maintain accuracy.

Laser Target

Explains the function of the laser target display in RI Viewer, indicating laser focus and potential hole location.

Hole Size Indicator

Describes the function and display of the Hole Size Indicator, which estimates the created hole size.

Exclusion Zone

Explains the Exclusion Zone feature for measuring proximity to critical cells to prevent heat damage.

How to Adjust Hole Size/Pulse Width

Details how to adjust hole size and pulse width parameters for laser operations using RI Viewer.

Preset Pulse Widths

Explains how to use and customize preset pulse width values for consistent laser delivery.

How to Fire the Laser (Single Pulse)

Provides instructions for firing the laser for single pulse operations, including sample positioning.

Biopsy Mode

Introduces Biopsy Mode for assisted hatching and embryo biopsy procedures, enabling automated shot delivery.

How to Enable Biopsy Mode

Guides on activating the Biopsy Mode feature in RI Viewer for automated laser shot sequences.

How to Fire the Laser (Biopsy Mode)

Details the steps for firing the laser using the Biopsy Mode, including line definition and start firing.

How to Shut Down

Explains the correct procedure for shutting down the system by closing software and unplugging the device.

SECTION 9 - TROUBLESHOOTING FOR SATURN 5 LASER SYSTEM

No lights on control unit

Addresses issues where the control unit shows no lights, suggesting power supply checks.

No video image

Provides solutions for problems related to the absence of a video image, checking camera connections and settings.

Laser having no effect

Offers troubleshooting steps for when the laser is not producing the expected effect, checking alignment and optics.

Hole size smaller than expected

Guides on resolving issues where the hole size is smaller than anticipated, checking calibration and pulse width.

Hole size larger than expected

Provides solutions for when the hole size is larger than desired, suggesting calibration and smaller hole size selection.

Laser position inaccurate

Addresses problems with the laser's position being inaccurate, recommending calibration checks.

SECTION 10 - CARE AND MAINTENANCE

Cleaning

Details recommended cleaning procedures for the system's control unit, optics, and microscope components.

Servicing

Explains the importance and schedule for regular servicing of the system by authorized technicians.

Disposal of Goods

Provides guidance on the environmentally safe disposal of electronic components and the system.

SECTION 11 - WARRANTY INFORMATION AND LIMITS ON LIABILITY

Warranty Information

Outlines the warranty terms and conditions, including duration and coverage, for the Saturn 5 Laser System.

Limits on Liability

Defines the limitations of liability for Research Instruments Ltd regarding product use and damages.

SECTION 12 - RETURNING PRODUCT TO RI FOR REPAIR

Returned Goods Policy

Details the policy and requirements for returning products for service or repair, including RMA procedures.

Customer Service Contact details

Provides contact information for customer service and support, including phone numbers and email.

Obligation to Inform

Explains the user's duty to inform RI and authorities about adverse events as per medical device directives.

Feedback

Invites users to provide feedback for product improvement and development of ART tools.