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Summary of Contents for K-Systems G210 InviCell
- Page 1 User Manual G210 InviCell Incubator Models: InviCell Standard and InviCell Plus with SignipHy™pH Monitoring System Document K32903(12) | Date: March 25, 2020 | DRF: 5394 2797 Only...
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Page 2: Table Of Contents
Accessory Order Codes Specification Table Section 6 - G210 InviCell Plus with SignipHy ™ pH Monitoring System External Sensors, pH / CO Dish Insert for pH monitoring External Temperature Additionally Supplied Accessories for G210 InviCell Plus with SignipHy pH Monitoring System... - Page 3 Contents Section 7 - Set-up Gas Supply Factory Settings Section 8 - Basic Operation Touchscreen Menu Main Menu Advanced Menu Chamber Information Edit Chamber Information Setpoint Changing the Temperature Setpoint Changing the Gas Setpoint Section 9 - Settings Changing the Date and Time Ethernet Settings Changing the Preparation Chamber Settings Changing Language...
- Page 4 Contents Section 10 - K-Link Starting K-Link Device Connection Measurement Section Alarm Display Section Graph Section Level Tab Pressure Tab Daily Average Tab Warning Tab Mail Tab Service Tab Section 11 - Troubleshooting Heating System Gas Regulator Gas Regulator Gas Consumption Touchscreen Section 12 - Maintenance Preparation at the Point of Use...
- Page 5 Preface Section 14 - Disposal and Recycling Environmental Protection for Disposal of the Product Recyclable Components Section 15 - Warranty Information and Limits on Liability Section 16 - Returning Product to CSI for Repair Customer Service Contact Details: US Only Customers Contact Details:...
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Page 6: Section 1 - Preface
G210 InviCell is designed to provide optimum conditions for gametes and embryos during long-term culture. For optimal use of the G210 InviCell, please read and follow the instructions in this User Manual. The incubator should be operated by trained personnel only. All sections of this manual should be read and understood fully before any operation of the incubator. -
Page 7: Section 2 - Safety
Use of other gases could result in serious injury, depending on the gas connected. DO NOT disassemble or modify any part of the G210 Invicell, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. -
Page 8: Cautions
Safety Cautions CAUTION • Caution: Federal law restricts this device to sale by or on the order of a physician or a practitioner trained in its use. • DO NOT use the incubator if ShockWatch or TipNTell has been triggered or if the package is damaged. -
Page 9: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Safety Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The G210 is intended for use in the electromagnetic environment specified below. The customer or the user of the G210 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The G210 uses RF energy only for its internal function. - Page 10 Safety IEC 61326-1 Compliance Electromagnetic environment - IMMUNITY Test Test level level guidance Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be (50/60 Hz) at levels characteristic of a typical commercial magnetic field environment. IEC 61000-4-8 Portable and mobile RF communications equipment should be used no closer to any part of the G210, including cables, than the recommended separation distance calculated...
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Page 11: Symbols
Safety Symbols Glossary ISO 15223-1:2016 Symbol Meaning WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. - Page 12 Safety Symbol Meaning This equipment must be protectively earthed Caution: US Federal law restricts this device for sale to or on the order of a licensed healthcare practitioner. Only Warranty label Ethernet Sample Port Sample port GAS (MAX 1 BAR) Gas Inlets CO Static sensitive (ESD) Fuse...
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Page 13: Section 3 - Installation
Incorrect installation could result in overall poor performance. The G210 InviCell is designed as a stationary unit and, therefore, not to be moved once it has been installed. If the incubator needs to be relocated, please contact Customer Service. -
Page 14: Section 4 - Device Description And Intended Use
This disposable cup is supplied sterile and is single use. The G210 InviCell overall dimensions are 860mm wide x 550mm deep x 180mm high, with a weight of 53kg (maximum). -
Page 15: Dish Inserts
Dish Inserts. Chamber Heating Each chamber is heated with K-Systems’ unique non-inductive EM Neutra™ heating system, which provides a uniform heat distribution. All chambers are equipped with individual temperature sensors to ensure stable temperatures at all times, and unidirectional gas flow across the chambers ensures even gas distribution in each chamber. -
Page 16: Section 5 - Product Overview
Product Overview Section 5 - Product Overview Main Components Components Incubator Chambers Touchscreen Preparation Chamber Origio Gas Line Filter G210 InviCell Standard and Plus models - front view G210 InviCell Standard and Plus models - raised top section... -
Page 17: Supplied Accessories For G210 Invicell Standard
**External computing devices connected to the Ethernet on the unit must only be Limited Power Source and SELV circuit according to the standards IEC/UL 60950-1. G210 InviCell Standard Model - back view (see page 20 for InviCell Plus) On base... -
Page 18: Accessory Order Codes
59902-1 Lid Seal for Preparation Chamber 59688 Gas sampler coupling 11103 G100 Gas Analyzer 11006 Solid Temperature Sensor (use with K-Systems F100 Thermometer) 59655 XLR6 Receptacle Connector 32903 G210 User Manual 60017 Connector for External CO sensor MTG (Plus models only) -
Page 19: Specification Table
Product Overview Specification Table Criteria Specification Overall dimensions, (L x W x H) 860mm x 550mm x 180mm Weight 53kg maximum Temperature range 35 – 42°C User interface Touchscreen Digital temperature readout, data logger, temperature User interface functions setpoint, calibration, warning for next service Connections Mains, CO gas, N... -
Page 20: Section 6 - G210 Invicell Plus With Signiphy Ph Monitoring System
All external sensors are completely independent of the functions and controls in the G210 InviCell Plus with SignipHy pH monitoring as they are connected to and powered by instruments independent of the G210 InviCell Plus with SignipHy pH Monitoring System. -
Page 21: Dish Insert For Ph Monitoring
Equipment needed: • 25 Pin D-Sub male connector prepared for soldering • 24VDC power supply Additionally Supplied Accessories for G210 InviCell Plus with SignipHy pH Monitoring System • Connector for GMP251 Carbon Dioxide Probe from Vaisala Oyj. Order code: 60014 •... -
Page 22: Section 7 - Set-Up
Set-up Section 7 - Set-up Before use, see chapter “Section 9 - Settings”. Gas Supply The G210 is not supplied sterile and should be cleaned before use. Make sure the gas input and output ports at the back of the incubator are also cleaned. See “Section 12 - Maintenance”... -
Page 23: Section 8 - Basic Operation
Basic Operation Section 8 - Basic Operation CAUTION: Do not use the incubator if the alarm system of the device has issued a failure message and the cause of the failure has not been corrected. It is important that the appropriate Dish Inserts are selected for the culture dishes used (LifeGlobal, Falcon, Nunc, Vitrolife) to ensure there is direct contact between the dish and the heated surface. -
Page 24: Main Menu
Basic Operation Main Menu Setpoint Settings Log Menu Calibration Service Alarm Advanced Date and View Time Main Menu The main screen provides an overview of the temperature and gas concentrations inside the incubator. Advanced Menu Press Advanced (1) in the main menu. -
Page 25: Chamber Information
Basic Operation The advanced menu shows the temperature in each chamber. Chambers that are marked with blue (2) are occupied, chambers marked green (3) are vacant. To return to the main menu press Basic (4). Patient ID (5). Chamber Information Press a chamber to get information about its status. -
Page 26: Log
Basic Operation The Log tab shows the temperature and gas concentration over a three hour period. Press the Flow/Press button (1) to see gas flow and pressure (see below image) over a three hour period. Press Level button (2) to return to temperature and gas concentration. -
Page 27: Changing The Temperature Setpoint
Basic Operation Enter the password and press OK (4). Changing the Temperature Setpoint Adjust the temperature setpoint by pressing the arrow buttons. Press Save (1). Changing the Gas Setpoint Adjust the gas setpoint by pressing the arrow buttons. Press Save (1) . It is recommended that gas concentrations are checked after changing the gas setpoint. -
Page 28: Section 9 - Settings
Settings Section 9 - Settings The Settings menu shows: Time settings (1) Date settings (2) Time format (3) Ethernet configuration (4) Security settings (5) System settings (6) Language (7) Basal Body Temperature (BBT) settings (8) To change some of these settings requires a login (see “Security Settings”... -
Page 29: Ethernet Settings
Settings Ethernet Settings Select the Configure button from the settings menu. It is recommend to allocte a static IP address to the device. Consult an IT Specialist/ Department for network settings. Select DHCP (1), or Static IP (2) If static IP is selected, enter the settings provided by the IT department. -
Page 30: Security Settings
Settings When BBT is activated the temperature in the setpoint menu cannot be changed. Press one of the four time buttons (A, B, C or D). Adjust the time value by pressing the up and down arrows (5). Adjust all four time values (3). Press Save (6). -
Page 31: Access Levels
Settings Access Levels The unit supports three access levels: User, Administrator and Advanced User. Their characteristics are shown below: Advanced User Administrator User (login required) (login required) Changes that do not require login Change setpoint Change settings ... -
Page 32: Edit User
Settings Edit User Select a user in the Security window, and press Edit (1) . The access level, name and password can be edited here. Press Save (2) when done. Change Password Press Change password (1) to change the admin password. Enter the current password (2). -
Page 33: Create A New User
Settings Create a New User In the security window, press New (1). Delete User Select a user in the security window, and press Delete (1). It is not possible to delete the “admin” user. Confirm ‘OK’ to delete a user. Log Out In the Security window press Logout (1). -
Page 34: Alarm
Settings Alarm A flashing red light alarm button indicates that an alarm has been activated. An audible alarm will also be activated. Press the alarm button to open the alarm message box. The alarm box shows information about the current alarm. Press Mute (1) to turn off the audible alarm. -
Page 35: Section 10 - K-Link
K-Link Section 10 - K-Link K-Link software can be used to communicate with a G210 over a TCP/IP network to retrieve, display and save a log of measurements, warnings, and daily averages into a spreadsheet. K-Link can also be configured to send email notifications when alarms are triggered. Starting K-Link To launch the K-Link software, double click on the K-Link icon on the desktop or in the start menu. -
Page 36: Measurement Section
K-Link WARNING: Ensure that the system time of the computer running the K-Link software and the system time of the G210 have both been set to the correct time before proceeding. NOTE: To ensure a stable connection between K-Link and the G210, it is recommended that the G210 be configured with a static IP address. -
Page 37: Graph Section
K-Link Graph Section The graphs displayed will automatically scale to fit the measurements however the Y-Axis can be adjusted by holding down the left mouse button and “dragging” a box around an area of interest then releasing the button. A single left-click anywhere on the graph will reset to the original scale. Level Tab The Level tab displays a graph of the gas concentration levels over time. -
Page 38: Pressure Tab
K-Link Pressure Tab The Pressure tab displays a graph of the device measurements over time. Daily Average Tab The Daily Average tab displays daily averages for the individual measurements collected from the device every 24 hours. -
Page 39: Warning Tab
K-Link Warning Tab The Warning tab displays information about the last 50 individual alarms. Mail Tab The Mail tab allows users to configure K-Link to email notifications about alarms and service information. NOTE: It is recommended to configure K-Link to use the specified mail server. Consult the IT Department for mail server information. -
Page 40: Service Tab
K-Link Service Tab The service tab presents software versioning information, device connectivity and serial number information. It also shows counters to indicate when a general service check, a filter change should be conducted. When the counters time out, the service alarm light is triggered and will remain active until all counters are reset. -
Page 41: Section 11 - Troubleshooting
Troubleshooting Section 11 - Troubleshooting Heating System Symptom Cause Action The temperature is more than Wrong temperature The alarm is on 0.5°C off from the setpoint, wait for the temperature to stabilize Wrong temperature on The setpoint for temperature Check the desired temperature touchscreen after system has is wrong setpoint... -
Page 42: Gas Consumption
Troubleshooting Symptom Cause Action Lid(s) are left open Close lid(s) Poor O gas regulation Seals are damaged or missing Check the seals are intact on lid(s) gas concentration more Allow system to stabilize by Concentration alarm than ±1% from setpoint closing all lids Check N gas supply, make sure... -
Page 43: Section 12 - Maintenance
Maintenance Section 12 - Maintenance Periodic cleaning is recommended as part of routine maintenance. Disinfection is also recommended for media spills, visual accumulation of dust, and other evidence of contamination. Clean and disinfect the G210, and when necessary sterilize the Dish Inserts, immediately after any media spills. -
Page 44: Sterilizing The Dish Inserts
Validation Check Perform the following validation gas and temperature checks after all cleaning, disinfecting and sterilizing or at least every two weeks to ensure the G210 InviCell is operating correctly. Gas Calibration It is very important the the G210 is not emptied of gas during the gas calibration procedure. To do so will cause unstable gas levels and gas flow and will result in a considerable time before the gas concentration is recovered and becomes reliable and stable again. -
Page 45: Gas Sample Port
Maintenance Gas Sample Port The gas sample port is located behind the Preparation Chamber. The Gas Sample Port is connected directly to the gas-mixing chamber. Connect a length of tubing to the gas analyser input. Connect the coupler (K59688) from the supplied accessories to the tubing. Remove the protection cap from the sample port. -
Page 46: Chamber Lid Plug
Maintenance Chamber Lid Plug A silicone plug is placed in the lid of each chamber. For collecting a gas sample, penetrate the lid plug with a needle attached to tubing and connect to the gas analyser input. Do not use needles larger than 0.5 mm x 25 mm. -
Page 47: Temperature Calibration
CSI recommends the F100 Precision Thermometer together with the Solid Temperature Sensor for temperature calibration. If the calibration is not performed with the K-Systems Solid Temperature Sensor, CooperSurgical cannot guarantee correct calibration of the device. -
Page 48: Section 13 - Service
Service Section 13 - Service WARNING: DO NOT disassemble or modify any part of the G210 InviCell For the reliable and safe operation of this incubator it is strongly recommended that inspections and services are performed as stated in the Service Plan below. Failing to follow this plan may cause the unit to stop performing as intended and cause damage to embryos, blastocysts etc. -
Page 49: Replacing The Origio Gas Line Filter
Service Replacing the Origio Gas line Filter Remove all samples from the chambers before replacing the filters. To access to the filter compartment, push the safety lock lever (1) and lift the upper part of the incubator containing the chambers. Fasten the connectors to the inlet and outlet of the Origio Gas Line Filter (2). -
Page 50: Section 14 - Disposal And Recycling
Disposal and Recycling Section 14 - Disposal and Recycling Information on recycling and handling of the unit as per the WEEE Directive (Waste Electrical and Electronic Equipment). CAUTION: Contamination Hazard As this device may have been used for processing and treating infectious substances, it might be contaminated. -
Page 51: Section 15 - Warranty Information And Limits On Liability
Warranty Information and Limits on Liability Section 15 - Warranty Information and Limits on Liability Coopersurgical Inc, warrants that this item will be free from defects in materials and workmanship for one year from the date of installation. If Coopersurgical (CSI) determines that the product fails to conform to that warranty during the one-year period, CSI will repair or replace the product, at CSI’s discretion, free of charge. -
Page 52: Section 16 - Returning Product To Csi For Repair
Returning Product to CSI for Repair Section 16 - Returning Product to CSI for Repair Please refer to the ‘Troubleshooting’ section in this manual before returning product to CSI. If the problem continues, please follow these instructions: Returned Goods Policy Goods will be accepted for return for the following reasons: •... -
Page 53: Customer Service Contact Details
Returning Product to CSI for Repair Customer Service Contact Details: Tel: +45 46 79 02 02 Fax: +45 46 79 03 02 E-mail: customerservice@origio.com coopersurgical.com US Only Customers Contact Details: Tel: 800-243-2974 Fax: 800-262-0105 coopersurgical.com...
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