Vitrolife EmbryoScope Flex User Manual
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Vitrolife EmbryoScope Flex User Manual

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EmbryoScope™ Flex incubator
User manual
EmbryoScope Flex incubator, software version 7.8
User manual, first issue 2021.08.02, revised 2022.06.01/EU/English

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Summary of Contents for Vitrolife EmbryoScope Flex

  • Page 1 EmbryoScope™ Flex incubator User manual EmbryoScope Flex incubator, software version 7.8 User manual, first issue 2021.08.02, revised 2022.06.01/EU/English...

  • Page 2: Table Of Contents

    2.2.1 Transportation and relocation of the EmbryoScope Flex incubator ....17 Starting up the EmbryoScope Flex incubator ..............18 Shutting down the EmbryoScope Flex incubator and removing all culture dishes ..18 Restarting the integrated PC ..................19 Connections to supporting systems .................. 20 Gas ..........................
  • Page 3 4.2.3 Settings screen ....................58 4.2.3.1 Enabling and disabling the screen saver ..........59 Cleaning and disinfecting the EmbryoScope Flex incubator ..........60 Periodic cleaning of the EmbryoScope Flex incubator ........... 60 Disinfection of the EmbryoScope Flex incubator ............63 Changing the VOC HEPA filter ....................
  • Page 4 15 Disposal of waste ....................... 112 16 Contact information ......................113 CohortView, CulturePro, EmbryoScope, EmbryoSlide, EmbryoViewer, Guided Annotation, iDAScore and KIDScore are trademarks or registered trademarks belonging to the Vitrolife Group. ©2022 Vitrolife A/S. All rights reserved. - 4 -...

  • Page 5: Introduction

    Planned service and maintenance to ensure error-free operation of the incubator. The EmbryoScope Flex incubator is a medical device that must be operated by trained personnel according to the instructions contained in this user manual. Users must be qualified to operate the device and qualified to perform procedures associated with device use in accordance with local qualification standards.

  • Page 6: Warnings, Restrictions And Limited Warranty

    RESTRICTIONS ON USE • The EmbryoScope Flex incubator may only be used by persons who have been trained in its use by a person certified by Vitrolife. • The EmbryoScope Flex incubator may only be used with sterile disposable EmbryoSlide Flex culture dishes produced and sold by Vitrolife.
  • Page 7 If the incubator is used in a manner not specified by Vitrolife, the protection against hazards provided by the incubator may be impaired. • The EmbryoScope Flex incubator is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. •...
  • Page 8 INSTALLATION AND SERVICE • Installation and service of the EmbryoScope Flex incubator may only be carried out by a person certified by Vitrolife. The EmbryoScope Flex incubator must remain at the location where it was installed. If the EmbryoScope Flex incubator is disconnected and/or moved without supervision by a person certified by Vitrolife, the incubator is no longer approved for clinical use and the warranty may be voided.
  • Page 9 ELECTROMAGNETIC COMPATIBILITY • The EmbryoScope Flex incubator has been tested and found to comply with the limits for medical devices set out in the IEC 60601-1-2 Edition 4.0 for electromagnetic compatibility. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

  • Page 10: Intended Use

    Users must inform Vitrolife A/S without any undue delay upon becoming aware of a cyber security vulnerability incident or any suspected security events. 1.2 Intended use The intended use of the EmbryoScope Flex incubator is to provide an environment with controlled temperature and gas concentrations (CO and optionally O ) for the culture of gametes and/or embryos and to acquire images of these during incubation.

  • Page 11: Clinical Benefits

    Improved implantation/pregnancy rate • Reduced pregnancy loss rate. 1.5 Proposed workarounds For details about any known anomalies and limitations in the software as well as proposed workarounds, refer to the separate handout on this subject provided by Vitrolife. - 11 -...

  • Page 12: Overview Of The Embryoscope Flex Incubator

    2 Overview of the EmbryoScope Flex incubator The EmbryoScope Flex incubator is a tri-gas incubator that acquires a series of unattended measurements on individual embryos during their development. The measurements include: time- lapse microscopy at multiple focal planes and logging of incubation conditions. Separate processing units control the incubation environment and data acquisition to ensure safe and reliable operation.

  • Page 13: Overview Of Features In The Embryoscope Flex Incubator

    EmbryoScope Flex incubator 2.1 Overview of features in the EmbryoScope Flex incubator The EmbryoScope Flex incubator comprises two separate systems: a computer and microscopy system that controls the image acquisition and a gas and temperature system that controls the incubation conditions.
  • Page 14 Culture dish holder The culture dishes are placed on the culture dish holder in the EmbryoScope Flex incubator. The culture dish holder is a sandwich construction controlled by a thermostat. The holder provides direct heat transfer to the EmbryoSlide Flex culture dishes and automatically moves the culture dishes from load position to camera position during time-lapse imaging.

  • Page 15: Barcode Labelling System

    EmbryoScope Flex incubator The incubation conditions inside the incubation chamber are unaffected by load door openings. The removable frame surrounding the culture dish in load position combined with the fixed partitions between the culture dishes shield the dishes contained within the incubator from outside atmospheric conditions.

  • Page 16: Installation And Required Conditions

    2.2 Installation and required conditions The incubator must be set up in accordance with the installation checklist. It should not be moved or disconnected by persons who are not certified by Vitrolife (see section 2.2.1 for information on how to move the incubator).

  • Page 17: Transportation And Relocation Of The Embryoscope Flex Incubator

    2.2.1 Transportation and relocation of the EmbryoScope Flex incubator The EmbryoScope Flex incubator must be moved by two persons positioned on each side of the incubator. Place one hand under the side of the incubator, and place the other hand to support the...

  • Page 18: Starting Up The Embryoscope Flex Incubator

    2.3 Starting up the EmbryoScope Flex incubator In order to start up the EmbryoScope Flex incubator (e.g. after service or cleaning), turn on the incubator by pressing the green main power switch on the back of the incubator. The incubator and integrated PC will then automatically start.

  • Page 19: Restarting The Integrated Pc

    EmbryoScope Flex incubator 2.5 Restarting the integrated PC In case an irrecoverable error occurs, an error message is displayed on the screen and the integrated PC will automatically restart when you press OK. To manually restart the PC: 1. Open the lid at the top of the incubator.

  • Page 20: Connections To Supporting Systems

    EmbryoScope Flex incubator 3 Connections to supporting systems A number of connectors and sockets are found at the back of the EmbryoScope Flex incubator. They should only be used by persons certified by Vitrolife for establishing the relevant connections during installation. Operators should never use or attach any tubing/wiring to the incubator without supervision.
  • Page 21 EmbryoScope Flex incubator In addition, a USB port that can be used by the clinic to extract monthly incubation reports is available under the service lid at the top of the incubator: USB port - 21 -...

  • Page 22: Gas

    EmbryoScope Flex incubator. NOTE • Two internal HEPA filter cartridges protect the sensitive valves and regulator inside the EmbryoScope Flex incubator from any particles in the airstream. - 22 -...

  • Page 23: Server

    EmbryoScope Flex incubator 3.2 ES server The EmbryoScope Flex incubator must be connected to an ES server. The connection is established by Ethernet cable and requires a special set-up, which must be performed by a person certified by Vitrolife. The incubator may not be connected directly to an internet gateway/ISP.

  • Page 24: External Alarm Output

    3.5 USB connections The back panel and the panel under the service lid at the top of the EmbryoScope Flex incubator each contain a USB port. The USB port on the back panel should only be used by persons certified by Vitrolife, e.g. to extract data for Vitrolife support.

  • Page 25: Operating The Embryoscope Flex Incubator

    Validating the individual incubation conditions and calibrating the EmbryoScope Flex incubator (see sections 4.1.4.2 and 4.1.5.3) • Turning on or off O regulation (see section 4.1.6.1) • Pausing auditory warning alarms issued by the EmbryoScope Flex incubator (see sections 8 and 8.2). - 25 -...

  • Page 26: Navigating On The Incubator Screen

    EmbryoScope Flex incubator 4.1.1 Navigating on the incubator screen When the incubator is in normal operation, the home screen is open. This screen displays the current incubation conditions, i.e. embryo temperature, CO concentration and O concentration: Home screen NOTE •...

  • Page 27: Change Set Point Mode

    EmbryoScope Flex incubator You can increase and decrease the set point in steps of 0.1 by using the + and - buttons: Home screen Set point details Change set point mode Press the current set Press the + and - buttons to...
  • Page 28 EmbryoScope Flex incubator This opens the set point details display: details When you open the details display, the large PC screen displays a graph of how the selected parameter has developed over a specific time period. The following example displays a graph of...

  • Page 29: Validation And Calibration Mode

    EmbryoScope Flex incubator When you have pressed the blue-framed Set Point button on the details display, the change set point mode is opened and you can modify the set point: Change set point mode See sections 4.1.4.1 and 4.1.5.1 for further information on how to change set points.
  • Page 30 EmbryoScope Flex incubator You can start your validation by pressing either CO and O , Temp. Sensor A or Temp. Sensor In the following example, temperature sensor B is validated. Validation mode. Press to go to calibration mode When the validation mode is opened, the large PC screen displays a graph of the selected parameter in Live mode.
  • Page 31 EmbryoScope Flex incubator The dotted green line displays the expected dish holder temperature, which should be the target if you need to calibrate the internal sensors. In the above example, the target temperature is 37.3°C. The set point is 37.0°C. Since there is a difference of 0.3°C between the temperature of the dish holder (where the current temperature is measured) and the embryo temperature, the target temperature of your calibration is 37.3°C.

  • Page 32: Controlling The Incubator Temperature

    EmbryoScope Flex incubator NOTE • After you have inserted the temperature probe, hold the probe to the right when closing the load door to avoid closing the load door lock directly on the probe. • Carefully remove the temperature probe after calibration/validation.

  • Page 33: Calibrating The Temperature

    5. Press the close button to return to the incubator home screen: 4.1.4.2 Calibrating the temperature The EmbryoScope Flex incubator must have been turned on for at least three hours to achieve full equilibrium before the temperature is calibrated. The room temperature must be equivalent to normal laboratory temperature.
  • Page 34 EmbryoScope Flex incubator This example covers calibration of temperature sensor B. Follow this procedure: 1. From the validation mode, press the blue-framed Temp. Sensor B button to enter the calibration mode: The calibration mode now opens: - 34 -...
  • Page 35 EmbryoScope Flex incubator The PC screen displays a graph of the temperature at the current point in time. The graph is displayed in Live mode. In this mode, the temperature graph is continually updated: 2. Press + on the small incubator screen to increase the temperature for sensor B in steps of 0.1°C, or press - to decrease the temperature in steps of 0.1°C until the displayed value...

  • Page 36: Controlling The Co Concentration

    EmbryoScope Flex incubator 4. After three minutes, when the graph on the PC screen displays a stable temperature regulation, validate the temperature by using the temperature probe. a) If the external temperature reading and the internal reading are now identical, press to exit validation mode.
  • Page 37 EmbryoScope Flex incubator 3. Press + to increase the gas concentration in steps of 0.1%, or press - to decrease the gas concentration in steps of 0.1%: These are the minimum and maximum set points (not applicable when ambient oxygen is...

  • Page 38: Validating The Co Concentration

    Before the CO concentration is validated, the EmbryoScope Flex incubator must have been turned on for at least three hours with the appropriate gasses connected to ensure that full equilibrium is attained. The room temperature must be equivalent to normal laboratory temperature.
  • Page 39 EmbryoScope Flex incubator 4. Remove the cover from the gas sample port: Cover to gas sample port. Access to gas sample outlet 5. Attach the tube from the gas analyser to the gas sample outlet: Gas sample outlet 6. Open the valve to withdraw a sample. The valve is open when the switch is turned to the...
  • Page 40 EmbryoScope Flex incubator The screen displays the current CO reading: 7. Compare the reading made by the external gas analyser with the current reading displayed on the incubator screen. 8. Either calibrate the gas concentration or return to the incubator home screen: a) In case the reading made by the external gas analyser and the current internal reading displayed on the screen differ by more than 0.1%, the gas concentration must be...

  • Page 41: Calibrating The Co Concentration

    4.1.5.3 Calibrating the CO concentration The EmbryoScope Flex incubator must have been turned on for at least three hours to achieve full equilibrium before the gas concentration is calibrated. If the reading made by the external gas analyser deviates from the current internal reading displayed on the screen, it is necessary to calibrate the internal gas sensors.
  • Page 42 EmbryoScope Flex incubator The PC screen displays a graph of the CO concentration at the current point in time. The graph is displayed in Live mode. In this mode, the graph is continually updated: 3. Press + on the small incubator screen to increase the gas concentration in steps of 0.1%, or press - to decrease the gas concentration in steps of 0.1% to match the values on the...

  • Page 43: Incubator O Regulation

    EmbryoScope Flex incubator 5. After 10 minutes, when the graph on the PC screen displays a stable gas regulation, validate the concentration by using the external gas analyser. a) If the external reading and the displayed internal reading are identical or differ only by 0.1%, press...

  • Page 44: The Pc Screen

    4.2 The PC screen 4.2.1 PC home screen The PC home screen of the EmbryoScope Flex incubator provides an overview of all EmbryoSlide Flex culture dishes that have been placed inside the incubator (see the following screen shot). Each patient may have more than one culture dish and thus be represented more than once in the overview.
  • Page 45 EmbryoScope Flex incubator Running culture dish. If you have selected at least Instrument one embryo for transfer via the EmbryoViewer, the Home number culture dish will appear in green colour button Patient ID Wells containing Equilibration dish Completed Days after...

  • Page 46: Starting An Embryoslide Flex Culture Dish

    Prepare the culture dish as specified in the user manual for the EmbryoSlide Flex culture dishes. The culture dish is now ready to be inserted in the EmbryoScope Flex incubator. The incubator will automatically scan and register the patient name, patient ID and treatment ID, provided that the incubator is connected to the ES server.
  • Page 47 EmbryoScope Flex incubator 3. Close the load door and confirm that you have inserted the culture dish. The EmbryoSlide Flex culture dish has now been inserted, and the barcode reader automatically registers the patient and treatment information from the barcode label.
  • Page 48 EmbryoScope Flex incubator If the barcode cannot be read, the following screen will appear: The Equilibration Dish(es) radio button is selected by default. Select the Embryo Culture Dish radio button to indicate that you have inserted a culture dish, and press the Continue button.
  • Page 49 7. Press Done. This button is dimmed until you have entered the date and time of insemination. Allow a few minutes for the autofocus procedure to determine the optimal focal planes for all selected wells. When the focal planes have been adjusted, the EmbryoScope Flex incubator will automatically proceed with the image acquisition. NOTE •...

  • Page 50: Barcode Errors

    EmbryoScope Flex incubator 4.2.1.3 Barcode errors When you insert a culture dish, the barcode reader will automatically attempt to detect a barcode on the culture dish. If the barcode reader is not functioning properly, or if the barcode is damaged or missing, a message will be displayed on the screen.
  • Page 51 EmbryoScope Flex incubator Message Cause Solution • Not possible to use the The barcode reader is Continue without barcode reader. currently not functional. barcodes. The system will continue • Restart the PC by without barcodes. pressing the reset When barcodes are not...

  • Page 52: Removing A Single Embryoslide Flex Culture Dish

    EmbryoScope Flex incubator 4.2.1.4 Removing a single EmbryoSlide Flex culture dish Follow this procedure to remove a culture dish either permanently or e.g. to change medium: 1. From the PC home screen, press the culture dish you want to remove.

  • Page 53: Resuming Culture In A Culture Dish

    EmbryoScope Flex incubator 4.2.1.6 Resuming culture in a culture dish You can resume culture in a culture dish if the incubator is connected to an ES server. Culture can be resumed in the same incubator or in another compatible incubator.
  • Page 54 EmbryoScope Flex incubator If you attempt to insert a culture dish in an incompatible incubator, you will see the following screen. Press OK to close this screen. - 54 -...

  • Page 55: Culture Dish Overview Screen

    EmbryoScope Flex incubator 4.2.2 Culture dish overview screen The culture dish overview screen contains general information that allows the operator to monitor the embryo development. To open the culture dish overview screen from the PC home screen, select a culture dish by pressing the corresponding button on the home screen.
  • Page 56 EmbryoScope Flex incubator Press one of the wells to see an enlarged image of the embryo: You can use the slider at the bottom of the screen to move between the images in the image series. Press the + and - buttons on each side of the slider to move one image forward or back, or drag the slider to move several images forward or back.

  • Page 57: Disabling Image Acquisition For Individual Wells

    EmbryoScope Flex incubator 4.2.2.1 Disabling image acquisition for individual wells If you want to disable image acquisition for specific wells, press the camera symbol on the culture dish overview screen: The camera symbol turns white, and you can now press the X for each of the wells that you want...

  • Page 58: Settings Screen

    EmbryoScope Flex incubator 4.2.3 Settings screen On the Settings screen, you can verify the connection to the server and re-establish the connection if necessary, choose between available display languages, set the exposure time for the time-lapse images and see the instrument number and software version of the incubator. You can also enable or disable the screen saver and set the idle time period after which the screen saver will be activated.

  • Page 59: Enabling And Disabling The Screen Saver

    EmbryoScope Flex incubator 4.2.3.1 Enabling and disabling the screen saver On the Settings screen, you can enable or disable the screen saver. If the screen saver is disabled, the text OFF is displayed under Screen Saver. Press the arrow up to enable the screen saver: Use the arrows to set the idle time period after which the screen saver will be activated, e.g.

  • Page 60: Cleaning And Disinfecting The Embryoscope Flex Incubator

    It is strongly recommended to clean and disinfect the EmbryoScope Flex incubator immediately after any media or oil spills. 5.1 Periodic cleaning of the EmbryoScope Flex incubator WARNING •...
  • Page 61 EmbryoScope Flex incubator 4. Unlock the load door by pressing the emergency unlock button. 5. Open the load door to the incubation chamber by pressing the white load door open button. 6. Check whether any more culture dishes remain inside the incubator. If one or more dishes remain, remove them as described in the emergency procedure in section 9.
  • Page 62 14. Apply clean, distilled water to lint-free tissue wipes and wipe the surfaces of the EmbryoScope Flex incubator. 15. Inspect the EmbryoScope Flex incubator. If the incubator is visually clean, it is ready for use. If it is not visually clean, go to step 7 and repeat the periodic cleaning procedure.

  • Page 63: Disinfection Of The Embryoscope Flex Incubator

    Use a disinfectant that is in accordance with laboratory policy. Wearing gloves and using good handling techniques are important to successful cleaning. Follow the below procedure to disinfect the EmbryoScope Flex incubator in case of contamination and/or spillage. 1. On the PC screen, press the settings icon. Then press Shutdown and remove all running culture dishes individually.
  • Page 64 EmbryoScope Flex incubator 4. Unlock the load door by pressing the emergency unlock button. 5. Open the load door to the incubation chamber by pressing the white load door open button. 6. Remove the load area frame. 7. Clean all internal surfaces: Apply clean, distilled water to lint-free tissue wipes and wipe all internal surfaces.
  • Page 65 Then reinsert the load area frame. 14. Inspect the EmbryoScope Flex incubator. If the incubator is visually clean, it is ready for use. If it is not visually clean, go to steps 8 to 13 and repeat the procedure.

  • Page 66: Changing The Voc Hepa Filter

    6 Changing the VOC HEPA filter NOTE • The VOC HEPA filter may be replaced either by a person certified by Vitrolife or by clinic personnel in case the filter needs replacement outside service visits. See section 13.2.3. • Always use a replacement filter delivered by Vitrolife. This is the only filter that will fit correctly into the quick connectors.
  • Page 67 EmbryoScope Flex incubator 4. Open the service lid at the top of the incubator to access the VOC HEPA filter. White quick connector Grey quick connector 5. To remove the VOC HEPA filter, follow the instructions on the following pages.
  • Page 68 EmbryoScope Flex incubator a) Press the grey quick connector (mounted in the filter tray), and pull the filter to the left: - 68 -...
  • Page 69 EmbryoScope Flex incubator b) Hold the VOC HEPA filter in upright position, and press the white quick connector while pulling the filter upwards to release it: - 69 -...
  • Page 70 EmbryoScope Flex incubator 6. Insert a new VOC HEPA filter by reversing the removal procedure: a) Insert the end of the VOC HEPA filter that has a red O-ring into the white quick connector: - 70 -...
  • Page 71 EmbryoScope Flex incubator b) Insert the end of the VOC HEPA filter that has a grey O-ring into the grey quick connector. Always observe the flow direction indicated on the filter: 7. Turn on the incubator by pressing the main power switch on the back.

  • Page 72: Replacing The Main Fuses

    EmbryoScope Flex incubator 7 Replacing the main fuses WARNING • Before attempting any of the following, ensure that the main power supply cord is completely detached from the incubator and that all culture dishes have been removed from the incubator.
  • Page 73 7. Attach the main power supply cord to the power inlet and switch on the incubator. 8. Re-insert the removed culture dishes after following the start-up procedure described in section 2.3. NOTE • If the main fuses become repeatedly defective, contact Vitrolife support for help. - 73 -...

  • Page 74: Alarms, Warnings And Notifications

    All alarm conditions are indicated by red visual and/or auditory signals on the incubator. They will also activate an external alarm if the EmbryoScope Flex incubator is connected to an external alarm system (see section 8.10). There may be a delay before the external alarm is activated, depending on the type and severity of the alarm (see section 8.10.2).

  • Page 75: Warnings

    Until the connection is re-established, the image acquisition will continue and the data will be stored on the hard disk of the EmbryoScope Flex incubator. The stored data will automatically be transferred to the ES server when the connection is re-established.

  • Page 76: Temporarily Pausing Alarms

    EmbryoScope Flex incubator 8.2 Temporarily pausing alarms Alarms activate an auditory signal that prompts you to take corrective action. To pause the auditory signal for three minutes, press the pause audio button: When one of the incubation conditions is not as expected (e.g. deviates from the set point), the button related to that specific condition will be coloured red on the incubator home screen.

  • Page 77: Overview Of The Display Colours Of Alarms, Warnings And Notifications

    EmbryoScope Flex incubator 8.3 Overview of the display colours of alarms, warnings and notifications Alarms, warnings and notifications are displayed with the colour scheme specified below. 8.3.1 Alarms Active alarms appear in red colour on the incubator home screen. Once the condition that caused the alarm is back within its normal range (i.e.

  • Page 78: Notifications

    EmbryoScope Flex incubator 8.3.3 Notifications Notifications always indicate that the connection to the server has been lost. Such notifications are shown in red colour in the lower left corner of the PC home screen: . Once the problem has been resolved, the notification is no longer active and the screen returns to normal view: 8.4 Multiple simultaneous alarms...

  • Page 79: Resetting Alarms

    EmbryoScope Flex incubator 8.5 Resetting alarms Only resolved alarms related to temperature, CO concentration and O concentration can be reset. Resolved alarms related to temperature, CO or O must be evaluated and reset in order to return to the default incubator home screen and enable operations such as changing set points or calibrating the sensors.

  • Page 80: Graphical Overview Of Alarms And Operator Response

    EmbryoScope Flex incubator 8.6 Graphical overview of alarms and operator response Alarms are activated when: • The temperature inside the incubator deviates from its set point • The CO concentration inside the incubator deviates from its set point • The O concentration inside the incubator deviates from its set point •...
  • Page 81 Operator response concentration is too high: concentration is too low: If the error condition cannot be immediately resolved, shut down the EmbryoScope Flex incubator from the PC home screen -> Settings screen -> Shutdown button. Then remove all culture dishes by following the instructions on the screen.
  • Page 82 EmbryoScope Flex incubator GAS CONNECTION Error condition 1 Error condition 2 Operator response If an oxygen bottle is If the error condition cannot be accidentally connected to the immediately resolved, turn off nitrogen inlet, an O high the EmbryoScope Flex...

  • Page 83: Graphical Overview Of Warnings And Operator Response

    EmbryoScope Flex incubator POWER FAILURE Error condition 1 Error condition 2 Operator response The power to the incubator If there is a complete power has been cut off. failure, turn off the EmbryoScope Flex incubator It is not possible to display a from the main switch located visible alarm signal.
  • Page 84 EmbryoScope Flex incubator IMAGE ACQUISITION STOPPED Error condition 1 Error condition 2 Operator response The image acquisition has Follow the instructions on the stopped due to unforeseen screen. circumstances: If the problem persists, call Vitrolife support. The display alternates with the...

  • Page 85: Graphical Overview Of Notifications And Operator Response

    EmbryoScope Flex incubator TEMPERATURE SENSOR ERROR Error condition 1 Error condition 2 Operator response One of the temperature Call Vitrolife support. sensors is not functioning properly. The other temperature sensor is still functioning correctly and controls the temperature in the microwell: 8.8 Graphical overview of notifications and operator response...

  • Page 86: Overview Of Error Conditions And Control Unit Responses

    EmbryoScope Flex incubator 8.9 Overview of error conditions and control unit responses Delay ”Resolved” indication Visual warning External alarm Auditory signal (visual and auditory) Error condition Alarm: Temperature Details Alarm: CO concentration Details 0 or 5 Alarm: O concentration Details...

  • Page 87: External Alarm System

    EmbryoScope Flex incubator 8.10 External alarm system The integrated alarm system in the EmbryoScope Flex incubator can be connected to an external alarm system through a plug that is located on the back of the incubator. The alarm signal of the EmbryoScope Flex incubator can be detected by most commercial external alarm systems that can notify users by phone, pager, SMS or e-mail.

  • Page 88: Delay Of External Alarms And Warnings

    The information contained in this section is primarily intended for technical staff members who are tasked with setting up the EmbryoScope Flex incubator with an external alarm. The four-pin alarm plug is labelled Alarm and placed on the back of the EmbryoScope Flex incubator (see section 3).

  • Page 89: Emergency Procedure

    • The emergency procedure may only be used when all other options to safeguard the running culture dishes have failed. 1. Turn off the EmbryoScope Flex incubator on the main power switch. The main power switch is the illuminated green switch on the back, upper left corner.
  • Page 90 EmbryoScope Flex incubator 3. Remove the load area frame. 4. Manually rotate the culture dish holder clockwise until a culture dish appears. Then remove the culture dish and place it in another incubator. 5. Remove the rest of the culture dishes by rotating the culture dish holder again and removing the next dish.

  • Page 91: Technical Specifications

    EmbryoScope Flex incubator 10 Technical specifications Additional information on the specifications is found under the respective sections in this manual. Incubator: • Capacity: 24 EmbryoSlide Flex culture dishes containing 6 embryos each, i.e. 144 embryos in total. • Temperature range: 36°C – 39°C. The temperature set point can be adjusted in steps of 0.1°C.
  • Page 92 EmbryoScope Flex incubator connected to N alarm: Displayed on the incubator screen when an oxygen bottle is accidentally connected to the nitrogen inlet and the O concentration therefore exceeds 25%. o Malfunction of the unit that controls the running conditions of the EmbryoScope...
  • Page 93 Isolation of poles: • Isolation of all poles simultaneously is achieved by either turning off the EmbryoScope Flex incubator by using the main power switch at the back of the incubator or by unplugging the power supply cord from the power supply socket.
  • Page 94 In case the boxes are damaged, contact Vitrolife immediately for further instructions. Do NOT open the boxes. Leave the EmbryoScope Flex incubator in the shipping boxes in a dry and safe place until it can be handled by a person certified by Vitrolife.

  • Page 95: Emc And Hf Technical Review

    Guidance and manufacturer’s declaration – electromagnetic emissions The EmbryoScope Flex incubator is intended for use in the home healthcare environment specified below. The customer or the user of the EmbryoScope Flex incubator should assure that it is used in such an environment.

  • Page 96: Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity The EmbryoScope Flex incubator is intended for use in the home healthcare environment specified below. The customer or the user of the EmbryoScope Flex incubator should assure that it is used in such an environment.
  • Page 97 Guidance and manufacturer’s declaration – electromagnetic immunity The EmbryoScope Flex incubator is intended for use in the home healthcare environment specified below. The customer or the user of the EmbryoScope Flex incubator should assure that it is used in such an environment.
  • Page 98 To assess the electromagnetic environment due to fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EmbryoScope Flex incubator is used exceeds the applicable RF compliance level above, the EmbryoScope Flex incubator should be observed to verify normal operation.
  • Page 99 Recommended separation distances between portable and mobile RF communications equipment and the EmbryoScope Flex incubator The EmbryoScope Flex incubator is intended for use in a home healthcare environment in which radiated RF disturbances are controlled. The customer or the user of the EmbryoScope Flex...

  • Page 100: Accessories And Materials

    EmbryoScope Flex incubator 12 Accessories and materials The following equipment and materials are needed to run the EmbryoScope Flex incubator: • EmbryoSlide Flex culture dishes (refer to the user manual for the EmbryoSlide Flex culture dishes) • EmbryoViewer • Lint-free cotton buds (see section 5) •...

  • Page 101: Planned Service And Maintenance

    13 Planned service and maintenance 13.1 Planned service A person certified by Vitrolife will inspect and replace all of the following items in accordance with the intervals specified in the below table, except for the VOC HEPA filter, which may also be...

  • Page 102: Planned Maintenance

    EmbryoScope Flex incubator 13.2 Planned maintenance In addition to the service tasks carried out by personnel certified by Vitrolife, it is the responsibility of the clinic to carry out the following maintenance tasks at regular intervals or as required: •...

  • Page 103: Maintenance Screen

    The pin code on the right side of the screen provides access to advanced maintenance functions to be carried out in collaboration with Vitrolife personnel. Vitrolife will issue a pin code if this is relevant. Press the Exit button to exit maintenance mode and return to the Settings screen.

  • Page 104: Generating A Monthly Incubation Report

    EmbryoScope Flex incubator 13.2.2 Generating a monthly incubation report To generate a monthly incubation report, insert a clean USB stick into the USB port under the service lid at the top of the incubator, and press the Incubation Report button. The following...

  • Page 105: Voc Hepa Filter And Sensor Maintenance

    EmbryoScope Flex incubator 13.2.3 VOC HEPA filter and sensor maintenance On the VOC Filter and Sensor Maintenance screen, the clinic can set reminders to change the VOC HEPA filter or to validate the internal sensors (temperature sensors A and B, the CO...
  • Page 106 EmbryoScope Flex incubator A warning will be shown on the PC home screen when it is time to change the VOC HEPA filter: If you press OK, the warning will disappear and remain hidden for three days. If you do not change the VOC HEPA filter within this period, the warning will reappear.
  • Page 107 EmbryoScope Flex incubator The default interval for validating the internal sensors is 14 days. This period can be changed by the clinic if required. Enter the new interval, and press the Interval Changed button. A warning will be shown on the PC home screen when it is time to validate the internal sensors: If you press OK, the warning will disappear and remain hidden for three days.

  • Page 108: Symbols And Labels

    EmbryoScope Flex incubator 14 Symbols and labels 14.1 Product information labels Label Description Note Model See the front page of the user manual. Model reference number Type of power supply See section 10. Declaration by the manufacturer that the device meets all of the...

  • Page 109: Warning Labels

    EmbryoScope Flex incubator Label Description Note Country of origin Serial number Model-version- production number Caution when See section 15. discarded Refer to the user manual 14.2 Warning labels Label Description Note Warns that the product Placed in the gas is equipped with a UV...

  • Page 110: Connection Labels

    14.3 Connection labels Label Description Note Gas sample pipe closed Found under the gas sample cover at the front of the EmbryoScope Flex incubator. Gas sample pipe open Found under the gas sample cover at the front of the EmbryoScope Flex incubator.

  • Page 111: Labels On The Shipping Crate

    EmbryoScope Flex incubator 14.4 Labels on the shipping crate Label Description Note Fragile This side up Keep dry Storage temperature: °C Minimum: -10°C Maximum: 50°C Humidity limitation: Minimum: 30% Maximum: 80% Atmospheric pressure limitation - 111 -...

  • Page 112: Disposal Of Waste

    EmbryoScope Flex incubator 15 Disposal of waste In order to minimise the waste of electrical and electronic equipment, waste must be disposed in accordance with the Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) as amended by Directive (EU) 2018/849. This includes: PCBs (lead-free HASL), switches, PC batteries, printed circuit boards and external electrical cables.

  • Page 113: Contact Information

    EmbryoScope Flex incubator 16 Contact information Urgently need help? Call our service hotline for support: +45 7023 0500 (available 24 hours a day, 7 days a week) E-mail support: support.embryoscope@vitrolife.com (response within two working days) Vitrolife A/S Jens Juuls Vej 20...

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