CooperSurgical K-Systems G185 Standard User Manual
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CooperSurgical K-Systems G185 Standard User Manual

Co2/o2 incubator
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User Manual
G185
CO
/O
Incubator
2
2
Models: Standard and SensorTech
Document K33070 | Issue: 10 | Date: July 03, 2018 | DRF: 4578
0086

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Summary of Contents for CooperSurgical K-Systems G185 Standard

  • Page 1 User Manual G185 Incubator Models: Standard and SensorTech Document K33070 | Issue: 10 | Date: July 03, 2018 | DRF: 4578 0086...

  • Page 2: Table Of Contents

    Contents Section 1 - Preface Section 2 - Safety Safety and Reliability Warnings Cautions Section 3 - Installation Placement Section 4 - Intended Use Applicable Part Numbers Significant Performance Characteristics Operation Principle User Profile Operating Environment Product Description Dish Inserts Section 5 - Product Overview Main Components Supplied Accessories for G185 Incubator...
  • Page 3 Contents Switching the Unit OFF (Standby Mode) Activating the Heat and Gas Controls Keyboard Lock Alarms Section 9 - Settings Advanced Function Menu Items Front Chamber Keys Timer Clock Alarm Switch for External Monitoring System Writing Pads for Chamber Lids and Penholder Section 10 - Data Logger System Requirements Software Installation...
  • Page 4 Contents Section 12 - Maintenance Periodic Cleaning Disinfection Sterilizing the Dish Inserts Via the Gas Sample Port Validation Check Gas Calibration Via Gas Chamber Lids Temperature Calibration Section 13 - Service Service Plan Replacing the H13 Filter Section 14 - Disposal and Recycling Environmental Protection for Disposal of the Product Recyclable Components Section 15 - Warranty Information and Limits...

  • Page 5: Section 1 - Preface

    Thank you for choosing a K-Systems product. We hope you will be happy with your G185. At CooperSurgical, we strive to provide the very best products and solutions for human IVF and the G185 is designed to provide optimum conditions for your embryos during long-term culture.

  • Page 6: Section 2 - Safety

    Safety Section 2 - Safety Safety and Reliability Please read this manual carefully and follow the instructions to ensure that the system will work safely and reliably. Safety is the responsibility of the laboratory. Risk assessment and working practices should comply with local regulatory policies. Warnings WARNING: Use only 100% pure CO and 100% pure N...

  • Page 7: Cautions

    Safety Cautions CAUTION • DO NOT use the incubator if ShockWatch or TipNTell has been triggered or if the package is damaged • Read and understand the manual completely before use. Keep the manual close to the unit • Never use or handle this unit in ways other than specified in this manual. Your safety may be at risk and the unit may get damaged •...
  • Page 8 Manufacturer Date of manufacture Waste electrical and electronic equipment • CooperSurgical, and its distributors within the European Union and associated states, have taken the necessary steps to comply with the directive 2012/19/EU on waste electrical and electronic equipment (WEEE) •...
  • Page 9 Safety Symbol Meaning Sample Port Sample port GAS (MAX 1 BAR) Gas Inlets CO Static sensitive (ESD) In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC 0086 EC REP Authorized Representative in the European Community...

  • Page 10: Section 3 - Installation

    Installation Section 3 - Installation Installation of the G185 should be carried out by a CooperSurgical Service Technician or other authorized personnel. Incorrect installation could result in overall poor performance. The G185 is designed as a stationary unit and, therefore, not to be moved once it has been installed.

  • Page 11: Section 4 - Intended Use

    Intended Use Section 4 - Intended Use To provide an environment with controlled temperature at or near body temperature and gas level and N ), for the development of human gametes and embryos during in vitro fertilization (IVF) treatment. Applicable indications for use are subject to the regulations of the country into which the device is sold and also the availability of the G185 for clinical use is dependent on the regulatory approval status of the incubator within the country.

  • Page 12: Product Description

    Intended Use Product Description The G185 is composed of 10 separate culture chambers (2) and one larger warming chamber (3). The 10 culture chambers are exposed to both heat and gas mixtures while the Dry Bath Chamber is exposed only to heat. The gas is constantly cleaned for particles, volatile organic compounds and bacteria by circulation through a HEPA and VOC filter and through a 254nm UV chamber.

  • Page 13: Section 5 - Product Overview

    Product Overview Section 5 - Product Overview Main Components Components Incubator Chambers User Interface Dry Bath Chamber H13 Filter Product label Mains connection with fuse Gas inlet connectors Alarm output G185 Standard and SensorTech models - front view G185 Standard model - back view...

  • Page 14: Supplied Accessories For G185 Incubator

    Product Overview Supplied Accessories for G185 Incubator Quantity Part Number Description 2-02-650 Mains Cable UK Plug 230V 2-02-651 Mains Cable Schuko Plug 230V 2-02-652 Mains Cable USA Plug 115V 2-02-662 Mains Cable Aus/China Plug 230V K11066 Silicone Tube (3 metre) K22123 Silicone Sealing Rings K53830...

  • Page 15: Technical Specifications

    Product Overview Technical Specifications Overall dimensions, (L x W x H) 922 x 570 x 165mm (with filter connected) Weight 38kg Ambient conditions Max. ambient temperature during operation 30°C Min. ambient temperature during operation 20°C Max. storage temperature 30°C Min. storage temperature -10°C Humidity Max.
  • Page 16 Product Overview Voltage 1/N/PE AC, 100-120VAC 60Hz or 220- Rated Voltage (system) 240VAC 50Hz Current Power consumption max. 240 VA Connecting gas inlet 1.0 bar/14.5 psi inlet 1.0 bar/14.5 psi Dish Inserts Suitable for Nunc Ø35mm, Ø51mm and Nunc dish insert 4 well IVF dishes Suitable for Falcon Ø50mm, 4 well IVF Falcon dish insert...

  • Page 17: Section 6 - G185 Sensortech

    Section 6 - G185 SensorTech G185 supports external and independent monitoring of the most critical parameters regarding CO concentration, temperature and pH measurement. CAUTION: Installations of external sensors must be performed by CooperSurgical or by persons authorized by CooperSurgical only External pH Monitoring This G185 SensorTech has been designed to work with Octax pH online.
  • Page 18 G185 SensorTech External Temperature and CO Monitoring The CO sensor recommended is a widely used sensor from Vaisala (GMP 251). It is a 0-10% high precision IR CO sensor. Vaisala offers several devices to support this sensor; both stand- alone and built-in modules. Port for external CO Sensor The sensor is placed in the rear part of the filter holder.

  • Page 19: Section 7 - Set-Up

    Set-up Section 7 - Set-up Before use, see“Section 8 - Basic Operation” & “Section 9 - Settings” Gas Supply The G185 is not supplied sterile and should be cleaned and or disinfected before use. Make sure the gas input and output ports at the back of the incubator are also cleaned. See “Section 12 - Maintenance”...

  • Page 20: Section 8 - Basic Operation

    Basic Operation Section 8 - Basic Operation CAUTION: Do not use the incubator if the alarm system 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 (Falcon, Nunc, Vitrolife) to ensure there is direct contact between the dish and the heated surface.

  • Page 21: System On Standby

    Basic Operation Meaning Display panel Shows information about the current status of the unit Setpoint Used to select an item in the menu in order to change its status. Also used to change temperature and gas setpoints Arrow keys up and down Used to navigate through the menu.

  • Page 22: Switching The Unit Off (Standby Mode)

    Basic Operation Switching the Unit OFF (Standby Mode) To switch OFF the unit (Standby mode), press and hold the On/Standby button for at least 5 seconds. The display will count down from 3 to 1 before the system enters standby mode. Action Display Press and hold the On/Standby button to...

  • Page 23: Keyboard Lock

    Basic Operation o2.C concentration in % After ‘o2.C’ is shown, the actual O concentration will be displayed for a few seconds NOTE: If CO regulation is deactivated the system will show ‘oFF’ right after ‘CO2.C’ has been displayed. NOTE: If O regulation is deactivated the system will display ‘oFF’...
  • Page 24 Basic Operation Alarm Display Reason The gas supply is not attached correctly, pressure alarm or wrong gas pressure is applied to the system, or gas bottles are empty gas concentration is deviating by more than one percent point from set value level alarm or O setpoint change is more than one...

  • Page 25: Section 9 - Settings

    Settings Section 9 - Settings Advanced Function It is possible to access a number of advanced functions via the menu. NOTE: You must have a good understanding of temperature and gas calibration before proceeding with the following operations in the menu. Instructions for entering, exiting and navigating the menu: Action Display...

  • Page 26: Menu Items

    Settings...
  • Page 27 Settings...
  • Page 28 Settings...
  • Page 29 NOTE: Gas concentration should be calibrated using an external precision gas analyzer through the gas sampling outlet. Only use a gas analyzer recommended by CooperSurgical NOTE: Always connect a 100% pure CO...

  • Page 30: Front Chamber Keys

    Settings NOTE: ‘tn-1’ is used to adjust the temperature of chambers 5 and 10 ‘tn-2’ is used to adjust the temperature of chambers 4 and 9 ‘tn-3’ is used to adjust the temperature of chambers 3 and 8 ‘tn-4’ is used to adjust the temperature of chambers 2 and 7 ‘tn-5’...

  • Page 31: Timer

    Settings CAUTION: Do not block the gas inlet/outlet in the middle of each chamber as this will cause incorrect gas concentration in the chamber Gas Inlet/Outlet minimized to less than 10 seconds under normal use, otherwise it may result in an alarm. The base of each chamber is a warmed area.

  • Page 32: Writing Pads For Chamber Lids And Penholder

    Settings NOTE: If a current source is attached to the connector, the maximum current rating is 1.0 Amp. NOTE: If a voltage source is attached then the limitation is between 0 – 24V AC or DC. If there is no alarm, the switch will be in ‘ON’...

  • Page 33: Section 10 - Data Logger

    Data Logger Section 10 - Data Logger System Requirements • IBM compatible PC running Windows 7 or later • Processor speed 1 gigahertz (GHz) or faster • Minimum 2GB RAM • 20 GB available hard-disk space • One available USB port •...

  • Page 34: Activating Data Log Function For Pc

    Data Logger Activating Data Log Function for PC Make sure that the communications protocol is activated in the menu. This can be checked by entering the menu and rolling down to ‘r232’. NOTE: The communication can be toggled between PC -> PDA ->OFF. The parameter must be set to “PC”...

  • Page 35: Starting The Data Logger Software

    Data Logger Starting The Data Logger Software Start the K-SYSTEMS data logger software from the programs list or by double-clicking the desktop icon. NOTE: If no incubator is connected, or if the incubator is switched off, the following error message is shown.

  • Page 36: Zoom In

    Data Logger Zoom In Click and drag on the desired area of the screen to zoom in. Zoom Out To restore the whole image, left-click on an empty area on the graph and move the cursor as shown on the graph below. The original axis scale values are then restored.

  • Page 37: Alignment

    Data Logger Alignment Move the cursor onto the graph, then click and hold the RH mouse button. Drag the graph to the desired position and release. Temperature and Gas level Select the “Temperature and Gas Level” tab to monitor temperature and gas levels. The most recent temperature data is shown on the left side of the screen, as shown below.

  • Page 38: Gas Flow And Pressure

    Data Logger Gas Flow and Pressure Select the“Gas Flow”and “Pressure” tab to monitor gas consumption and pressure levels. NOTE: The CO and N gas flow is not a static value and is automatically adjusted by the system. The Daily Average Select the “Daily Average”...

  • Page 39: Warnings Menu

    Data Logger Warnings Menu All warnings are listed in the “Warnings” menu. The reason for the alarm is logged i.e. • gas level alarm • gas pressure alarm • gas level alarm • gas pressure alarm • Temperature alarm These alarm conditions are also shown as green or red circles at the bottom of the datalogger window. A red circle indicates an active alarm.

  • Page 40: Mail

    Data Logger Mail The data logger is able to send an e-mail to the user in case of any alarm. Select the “Mail” tab to set this up. NOTE: In order to use this function, the user must have provided valid e-mail account and outgoing mail server settings.

  • Page 41: Log Files

    Data Logger Log Files To access the log files directly, click “Open Log Directory” at the bottom left of the screen. Log files contain the following information: • Temperature • Gas Level • Gas Flow • Gas Pressure • Daily Average •...

  • Page 42: Section 11 - Troubleshooting

    Troubleshooting Section 11 - Troubleshooting Heating System Symptom Cause Action The temperature is more than 0.5°C from the setpoint, wait Wrong temperature The alarm is on for the temperature to stabilize. Consider removing samples to a different incubator Wrong temperature on touch The setpoint for temperature screen after system has had Check the setpoint...

  • Page 43: Gas Regulation

    Troubleshooting Gas Regulation Symptom Cause Action System not powered on Check mains and main fuse System is on standby or Switch the system on switched off Activate O gas regulator by gas regulator is OFF setting ‘O2.r’ to on in the menu, “Caution”...

  • Page 44: Display

    Maintenance Display Symptom Cause Action Replace the PCB. Contact a Missing segment(s) in display Failure in the PCB service technician for help Keyboard Symptom Cause Action Absent or erratic function of Replace keyboard. Contact a Failure in the keyboard operation buttons service technician for help...

  • Page 45: 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 G185, and when necessary sterilize the Dish Inserts, immediately after any liquid spills.

  • Page 46: Via The Gas Sample Port

    To ensure the G185 is not emptied of gas during the gas sampling please follow these instructions. Always use a gas analyzer recommended by CooperSurgical. The calibration procedure described here assumes the use of the G100 Gas Analyzer (Order Code: 11103) which recirculates gas into the gas flow during sampling.

  • Page 47: Via Gas Chamber Lids

    Maintenance Via Gas Chamber Lids The gas level can also be validated by taking a small gas sample from each of the chambers. Connect the output port of the gas analyzer to the Gas Sample Port on the back of the unit. Connect the input port with a short length of tubing to a hollow needle.

  • Page 48: Temperature Calibration

    Sensor for temperature calibration. If the calibration is not performed with the Solid Temperature Sensor, CooperSurgical cannot guarantee correct calibration of the device. NOTE: The sensor and thermometer should be calibrated as a unit and only by an accredited test house.
  • Page 49 Maintenance Move your temperature sensor to chamber 1 or 6 and repeat the calibration, but adjust tn-5 until you have a stable temperature in the chamber Move the temperature sensor to chamber 3 or 8 and adjust tn-3 Move the temperature sensor to chamber 5 or 10 and adjust tn-1 Move the temperature sensor to chamber 2 or 7 and adjust tn-4 Move the temperature sensor to chamber 4 or 9 and adjust tn-2 Once the system has stabalized, all temperatures must be within 0.2°C of the setpoint.

  • Page 50: Section 13 - Service

    Service Section 13 - Service WARNING: DO NOT disassemble or modify any part of the G185 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 etc.

  • Page 51: Replacing The H13 Filter

    Service Replacing the H13 Filter The VOC H13 Filter is a combined HEPA (High Efficiency Particulate Air) and VOC (Volatile Organic Compound) filter. It is mounted on the side of the unit for easy access and replacement. The purpose of the filter is to remove airborne particles and VOCs in the air being circulated within the incubator. The HEPA/VOC filter capsule has a limited life in use of 3 months and therefore, it is important to replace it on time in order to...

  • Page 52: Section 14 - Disposal And Recycling

    If any electronic component is no longer serviceable, it must be sent back to CooperSurgical to be destroyed in an environmentally safe way. Do not dispose of with ‘normal’ waste The following table provides information on the recycling and handling of the product in accordance...

  • Page 53: Section 15 - Warranty Information And Limits On Liability

    Section 15 - Warranty Information and Limits on Liability CooperSurgical warrants that this item will be free from defects in materials and workmanship for one year from the date of initial purchase. If CooperSurgical determines that the product fails to conform to that warranty during the one-year warranty period, CooperSurgical will, as the sole remedy for that failure to conform, repair or replace the product, at CooperSurgical’s discretion, free of charge.

  • Page 54: Technical Support/Service Representatives

    • Date of receipt of order • Customer’s purchase order and the (CooperSurgical or ORIGIO) invoice number All used goods must be decontaminated prior to shipment. A signed decontamination declaration may be required. Shipment must be sent prepaid by the customer. Freight collect shipments will not be accepted, and goods will be returned to sender.
  • Page 55 Troubleshooting...

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