K-Systems G210 InviCell User Manual

Models: InviCell Standard and InviCell Plus with
SignipHy™pH Monitoring System
User Manual
G210 InviCell
Long-Term Incubator
Document K32903(15) | Date: 11 December 2023 | DRF: 6231
+45 46 79 02 02 | sales@coopersurgical.com | fertility.coopersurgical.com
CooperSurgical, Inc.
95 Corporate Drive, Trumbull, CT 06611, USA
Only
2797
a CooperSurgical Fertility Company

K-Systems G210 InviCell Specifications

General

Brand	K-Systems
Model	G210 InviCell
Category	Accessories
Language	English

Summary

Section 1 Preface

Section 2 Introduction

Intended Purpose

Defines the G210 InviCell's use in ART treatments for gamete and embryo development.

Principal Mode of Operation

Explains the incubator's function in maintaining controlled environmental conditions for gametes and embryos.

Disease/Conditions Treated

Discusses infertility as a condition addressed by Assisted Reproductive Technology (ART) treatments.

Intended User and Environment

Specifies that only trained ART professionals should operate the device in a clinical setting.

Applicable Part Numbers

Lists the part numbers for the G210 InviCell Standard and Plus models.

Operation Principle

Describes the process of culturing gametes and embryos for 6-7 days within the incubator.

Section 3 Safety Warnings

Safety and Reliability

Emphasizes careful reading and adherence to manual instructions for safe and reliable incubator operation.

Critical Warnings

Critical safety alerts regarding gas usage, unauthorized modifications, electrical connections, and operational environment.

Essential Cautions

Essential precautions for device protection, safe operation, and preventing damage or injury.

Electromagnetic Emissions Guidance

Provides guidance on the proper electromagnetic environment for G210 operation.

Electromagnetic Immunity Guidance

Details immunity test levels and guidance for the G210's electromagnetic compatibility.

Safety and Information Symbols Glossary

Explains the meaning of various safety and information symbols used in the manual.

Section 4 Installation

Placement and Environment

Specifies environmental requirements and necessary clearance for incubator installation.

Section 5 Product Overview

Main Components Overview

Identifies and illustrates the key physical components of the G210 InviCell.

Standard Model Supplied Parts

Lists all parts included as standard with the G210 InviCell Standard unit.

Technical Specification Table

Presents detailed technical specifications, including dimensions, power, and operating conditions.

Section 6 G210 InviCell Plus with SignipHy pH Monitoring System

External Sensors for pH and CO₂

Lists compatible external sensors for monitoring pH and CO₂ with the Plus model.

pH Monitoring Dish Inserts

Describes specialized dish inserts required for pH monitoring functionality.

Plus Model Accessories

Details accessories specifically supplied with the G210 InviCell Plus model.

Section 7 Set-up

Gas Supply Setup

Guides on connecting and preparing the gas supply for the incubator.

Factory Settings Configuration

Lists the default temperature and gas concentration settings programmed at the factory.

Section 8 Basic Operation

Touchscreen Interface Operation

Explains how to navigate and use the incubator's touchscreen controls.

Setpoint Adjustment

Details how to view and modify temperature and gas concentration setpoints.

Temperature Setpoint Adjustment

Step-by-step instructions for changing the incubator's temperature setpoint.

Gas Setpoint Adjustment

Step-by-step instructions for adjusting the CO₂ and O₂ gas setpoints.

Section 9 Settings

Date and Time Settings

Instructions for adjusting the device's date, time, and preferred time format.

Ethernet Network Configuration

Guides on configuring network settings, including IP address allocation.

Security Settings and Access Levels

Explains how to manage user access levels and enhance device security.

Password Management

Procedures for editing user profiles and changing administrator passwords.

Alarm and Error Handling

Information on interpreting alarms, error codes, and managing alerts.

Section 10 K-Link Software

Starting and Connecting K-Link

Instructions for launching the K-Link software and establishing device connections.

Data Visualization Tabs

Describes viewing graphical data for measurements, gas levels, and pressure in K-Link.

K-Link Mail and Warning Notifications

Configuration of email notifications for alarms and service events within K-Link.

Section 11 Troubleshooting

Heating System Issues

Addresses common problems and solutions related to the incubator's heating system.

Gas Regulator Problems

Troubleshooting steps for CO₂ and O₂ gas regulators and concentration issues.

Touchscreen Malfunctions

Guidance on resolving issues with the incubator's touchscreen interface.

Section 12 Maintenance

Cleaning and Disinfection Procedures

Outlines routine cleaning, disinfection, and drying protocols for the incubator.

Gas and Temperature Calibration

Details critical procedures for calibrating gas concentrations and temperature sensors.

Gas Concentration Verification

Steps to verify and ensure accurate gas concentrations within the chambers.

Section 13 Service

Recommended Service Plan

Specifies the schedule for routine inspections and part replacements.

Replacing the Gas Line Filter

Step-by-step guide for replacing the Origio Gas Line Filter.

Section 14 Disposal and Recycling

Product Disposal and Environmental Compliance

Information on environmentally responsible disposal according to WEEE directives.

Section 16 Returning Product for Repair

Product Return Policy and Procedure

Outlines the policy for returning products and the required authorization process.

Incident Reporting Obligation

Requirements for reporting serious incidents involving the device to CooperSurgical and health authorities.