Esco Medical MIRI TL Series User Manual
  1. Manuals
  2. Brands
  3. Esco Medical Manuals
  4. Laboratory Equipment
  5. MIRI TL Series
  6. User manual

Esco Medical MIRI TL Series User Manual

Multiroom ivf incubators
Hide thumbs
Table of Contents

Advertisement

Quick Links

CE 0088
USER MANUAL
MIRI
TL family`s multiroom IVF
®
incubators
Rev. 1.0
Date of Revised 05.04.2021
Rx only

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the MIRI TL Series and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Esco Medical MIRI TL Series

Summary of Contents for Esco Medical MIRI TL Series

  • Page 1 CE 0088 USER MANUAL MIRI TL family`s multiroom IVF ® incubators Rev. 1.0 Date of Revised 05.04.2021 Rx only...
  • Page 2 Esco Medical Technologies, Ltd. Draugyste s street 19 • Kaunas, Lithuania Tel +370 37 470 000 medical.escoglobal.com • support-medical@escoglobal.com For Technical Service, contact North America Esco Technologies, Inc. 903 Sheehy Drive, Suite F, Horsham, PA 19044, USA Tel 215-441-9661 • Fax 484-698-7757 www.escolifesciences.us •...
  • Page 3 (2) years from the original purchase date, provided the instrument is calibrated and maintained following this manual. During the warranty period, Esco Medical will, at our option, either repair or replace a product MIRI TL family`s multiroom IVF incubators User Manual Rev.
  • Page 4 This warranty is limited to repairing the instrument per Esco Medical's specifications. When you return an instrument to Esco Medical for service, repair or calibration, we recommend shipment using the original shipping foam and container. If the original packing materials are not available, we recommend the following guide for repackaging: •...
  • Page 5 In an event where the seal must be broken to gain internal access to the instrument, you must first contact Esco Medical Ltd. You will be required to provide us with the serial number for your instrument, as well as a valid reason for breaking the Quality Seal.

  • Page 6: Table Of Contents

    Table of contents 1 How to use this manual .......................... 11 2 Safety warning ............................11 3 Indication for use ............................12 4 About the product ............................ 12 5 Transport, Storage and Disposal ......................14 5.1 Transportation requirements ..................... 14 5.2 Storage and operation environment requirements ............
  • Page 7 13.5.5 UV-C Light sub-menu ......................39 14 Alarms ................................ 39 14.1 Temperature alarms ........................40 14.2 Gas level alarms ..........................41 14.2.1 CO alarms ..........................41 14.2.2 O alarms ..........................42 14.3 Gas pressure alarms ........................42 14.3.1 CO pressure alarm ....................... 42 14.3.2 N pressure alarm .........................
  • Page 8 23 Cleaning instructions ........................... 75 23.1 Consideration about a sterile device ..................75 23.2 Cleaning procedure recommended by the manufacturer ..........75 23.3 Cleaning procedure recommended by the manufacturer ..........76 24 Temperature validation ........................77 25 Gas level validation ..........................77 26 Alarm switch for an external system ....................
  • Page 9 35.8 Temperature check: Compartment bottoms ............... 95 35.9 Temperature check: Compartment lids ................96 35.10 6-hour stability test ........................97 35.11 Cleaning ............................98 35.12 Test documentation form ......................98 35.13 Recommended additional testing ..................98 35.13.1 A VOC meter.......................... 98 35.13.2 A laser particle counter ....................
  • Page 10 38.1 Responsibilities ........................... 110 38.2 Before installation ........................111 38.3 Preparing for installation ......................111 38.4 Bring the following to the installation site ............... 112 38.5 Installation procedure at the site ..................112 38.6 User training ..........................112 38.7 After the installation ......................... 113 MIRI TL family`s multiroom IVF incubators User Manual Rev.

  • Page 11: How To Use This Manual

    1 How to use this manual The manual is designed to be read by sections and not ideally from cover to cover. It means that if the manual is read from start to finish, there will be some repetition and overlap.

  • Page 12: Indication For Use

    The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development. 4 About the product The Esco Medical MIRI TL family`s multiroom IVF incubator are a CO incubators ®...
  • Page 13 The multiroom IVF incubator features a recirculated gas system where gas is continuously put into the compartment and taken out at the same rate. Gas is cleaned via 254 nm UVC light with direct gas contact between the bulb and gas, then through a VOC filter and through a HEPA filter.

  • Page 14: Transport, Storage And Disposal

    Personal Protective Equipment (89/686/EEC) and Machine Directive (2006/42/EC) is not applicable for the MIRI TL family`s multiroom IVF incubators. Also, the MIRI ® ® family`s multiroom IVF incubators does not contains or incorporates: a medical substance, including a human blood or plasma derivate; tissues or cells, or their derivates, of human origin;...

  • Page 15: Disposal

    5.3 Disposal Information on handling of the unit as per the WEEE Directive (Waste Electrical and Electronic Equipment). The device may have been used for treating and processing infectious substances. Therefore, the device and device components may be contaminated. Prior to disposal, the whole device must be disinfected or decontaminated. The unit contains reusable materials.

  • Page 16: Safety Symbols And Labels

    7 Safety symbols and labels There are several user labels on the surface of the MIRI TL6 and MIRI TL12 multiroom ® ® IVF incubators to guide the user. User labels are shown below. Table 7.1 Packing box and electrical safety labels Description Image Packing box label:...
  • Page 17 Table 7.2 Device label Description Image 1. Model. 2. Mains power rating. 3. CE mark. 4. Not protected against the ingress of water. 5. Manufacturer's address and country of origin. 6. View instruction for use. 7. Observe WEEE. 8. Upper limit of temperature. 9.
  • Page 18 Compartment numbers are indicated on the top corner of the lid with a label Maximum pressure 0.8 bar VOC/HEPA filter Ethernet TL on/off PT 1000 validation sensors Gas sample ports Compartment numbers are shown in the pictures below and also indicated on top of lids with a label.

  • Page 19: Important Safety Instructions And Warnings

    8 Important safety instructions and warnings 8.1 Before installation 1. Do not use the product if the package is damaged. Contact Esco Medical or the local representative. 2. Read the user manual thoroughly before use. 3. Always keep these instructions easily accessible near the device.

  • Page 20: Getting Started

    0.4 – 0.6 bar (5.80 – 8.70 PSI). 11. Never use any other except Esco Medical filter. Otherwise, the warranty will be void. 12. Do not use the device without a proper Esco Medical VOC/HEPA filter attached.

  • Page 21: Gas Connections

    The ON/OFF switch provides the user with a means to isolate the MIRI TL6 and MIRI ® ® TL12 multiroom IVF incubator from the mains. Do not defeat the safety purpose of the grounding-type plug! A grounding-type plug has two blades and a prong, which is provided for your safety. If the provided plug does not fit into your outlet, consult an electrician to replace the outlet.

  • Page 22: Hepa/Voc Filter

    Gas pressure for both inlets should be between 0.4 – 0.6 bar (5.80 – 8.70 PSI), and it must be kept stable! Always use a high-quality pressure regulator that can be set with the required precision for both gases. Figure 11.2 Pressure regulator Connect CO gas to the CO inlet with a suitable silicone tube.

  • Page 23: Installation Of A New Filter Capsule

    VOCs are typically measured in parts per million (ppm.) They can also be reported in parts per billion (ppb.) For IVF, the recommended count below 0.5 ppm; the total quantity of VOCs should be below <0.2 ppm or preferably zero. High levels of VOCs (over 1 ppm) are toxic to embryos, resulting in poor embryo devel- opment and even probable failure to reach the blastocyst stage.

  • Page 24: User Interface

    Figure 12.3 Filter in place Then, simultaneously press both angle fittings (using both hands) into the holes till they snap into place. The last 4 mm step should feel stiff. A filter element that has been fitted incorrectly will cause the unit to work not as intended.

  • Page 25: Activating The Heat And Gas Controls

    13.1 Activating the heat and gas controls Heat and gas control systems are activated using the ON/OFF switch in the rear. Figure 13.1 MIRI TL6 multiroom IVF incubators rear ® The "Please Wait" message appears on the screen while the system is booting up for work. Figure 13.2 Loading view Soon after system activation, the main display will show the following parameters: •...
  • Page 26 Figure 13.3 Main display in the MIRI TL6 multiroom IVF incubator ® Figure 13.4 Main display in the MIRI TL12 multiroom IVF incubator ® The user can directly access the second main display from the main display by pressing the (◁) button. Figure 13.5 The second main display The second display shows temperature, CO and O...

  • Page 27: Temperature Setpoint

    Figure 13.6 The second main display Exit back to the main display by pressing the (▷) button. 13.2 Temperature setpoint The MIRI TL6 multiroom IVF incubator user interface images will be used as ® an example for all the temperature setpoints. The temperature setpoint can be adjusted in the range of 28.7 °C to 41.0 °C in both MIRI ®...
  • Page 28 Figure 13.7 Main display view in the MIRI TL6 multiroom IVF incubator ® 2. The new setpoint page will appear. Press the "Temperature Setpoint" button: Figure 13.8 Setpoint page display view in the MIRI TL6 multiroom IVF incubator ® 3. In the new window, the user can choose the compartment for which he wants to set the setpoint.

  • Page 29: Co Setpoint

    Figure 13.10 Temperature setpoint view in the MIRI TL6 multiroom IVF incubator ® When the desired value is set, press the "EXIT" button. The value will be saved automatically. Repeat steps for other compartments if "Multi-Temperature SP" is "ON". If "Multi- Temperature SP"...

  • Page 30: O 2 Setpoint

    2. The new setpoint page will appear. Press the "Gas Setpoint" button: Figure 13.12 Setpoint page view in the MIRI TL6 multiroom IVF incubator ® 3. Use arrow up and down buttons to set the value: the arrow "DOWN" decreases the value, the arrow "UP"...
  • Page 31 1. In the main display, press the "Setpoint" button: Figure 13.14 Main display view in the MIRI TL6 multiroom IVF incubator ® 2. The new setpoint page will appear. Press the "Gas Setpoint" button: Figure 13.15 Setpoint page view in the MIRI TL6 multiroom IVF incubator ®...

  • Page 32: System Menu

    13.5 System menu In the main display, press the "Menu" button. The main menu consists of 5 sub-menu applications: "Calibration", "CO Setup", "O Setup", "Temperature Setpoint", "UV-C Light". Figure 13.17 System menu view in the MIRI TL6 and MIRI TL12 multiroom IVF incubators ®...
  • Page 33 Figure 13.19 12 calibration zones in the MIRI TL6 multiroom IVF incubator ® Each compartment has two internal temperature sensors. One in the compartment lid and another in the compartment bottom. Temperature calibration in the MIRI TL12 multiroom IVF incubator consists of two ®...
  • Page 34 Figure 13.22 Temperature calibration zones for Compartments 7-12 in the MIRI TL12 multiroom IVF ® incubator In the MIRI TL12 multiroom IVF incubator, each 12 compartment consists of "UP" and ® "DOWN" buttons. To calibrate the compartment's top temperature, use the "UP" button and calibrate the compartment's bottom temperature and use the "DOWN"...
  • Page 35 The calibration procedure is the same for T1 – T12 (for the MIRI ® multiroom IVF incubator) and T1 – T24 (for the MIRI TL12 multiroom IVF ® incubator). “T1” is used to adjust the bottom temperature of compartment 1. “T7” is used to adjust the lid's temperature in the same compartment.
  • Page 36 the gas sample ports (all ports can be used for this purpose). It was estimated to be 6.4%. Calibration is performed by adjusting the CO level according to the measurement taken from the gas sampling outlet by an external reliable CO measurement device.

  • Page 37: Co Setup Sub-Menu

    without delay. 13.5.2 CO Setup sub-menu Press the “CO Setup” button in the main menu view. The user can activate or deactivate the CO regulation. If the CO regulation is activated, the setpoint value must be set. Figure 13.25 CO Setup sub-menu view in the MIRI TL6 and MIRI TL12 multiroom IVF incubator...

  • Page 38: Temperature Setpoint Sub-Menu

    The default status for O control is "OFF". The O flow rate is shown when the setpoint value is set. The flow rate cannot be adjusted because this is the amount of O gas put into the system while regulating. The volume is shown in liters per hour.

  • Page 39: Uv-C Light Sub-Menu

    13.5.5 UV-C Light sub-menu Press the “UV-C Light” button in the main menu view. Figure 13.28 UV-C Light regulation in the MIRI TL6 and MIRI TL12 multiroom IVF incubator ® ® The default status for the UVC light is "ON". The UV-C light will automatically switch off when the unit is turned off.

  • Page 40: Temperature Alarms

    14.1 Temperature alarms All 6 compartments in the MIRI TL6 multiroom IVF incubator and 12 compartments in ® the MIRI TL12 multiroom IVF incubator can trigger a temperature alarm if the ® temperature in them deviates more than ±0.5 °C from the setpoint. Remember that changing the setpoint more than ±0.5 °C from the current temperature will result in an alarm.

  • Page 41: Gas Level Alarms

    Figure 14.4 Temperature sensor malfunction view on the main display in the MIRI TL6 multiroom IVF ® incubator The T3 temperature sensor in compartment 3 is malfunctioning, and as a safety precaution, the heating for the affected zone will be shut down. 14.2 Gas level alarms 14.2.1 CO alarms...

  • Page 42: O 2 Alarms

    14.2.2 O alarms The O level alarm is activated if the concentration of O gas deviates more than ±1% from the set value. Remember that changing the setpoint more than ±1% from the current gas level will result in an O level alarm.

  • Page 43: Pressure Alarm

    Figure 14.7 CO gas pressure alarm view on the main display in the MIRI TL6 multiroom IVF incubator ® An audible alarm is also activated, but it can be muted by pressing the alarm key. If the mute key is pressed, the audio sound will be muted for 5 minutes. 14.3.2 N pressure alarm If the N...

  • Page 44: Multiple Alarms

    Figure 14.9 UV-C light malfunction alarm view on the main display in the MIRI TL6 multiroom IVF ® incubator The user should consult the distributor for further guidance or service inspection. The "S. UV" will disappear only when the UV-C light will be working again. 14.5 Multiple alarms In the picture below, the temperature is too high in the T1 zone, the CO gas is not...

  • Page 45: Surface Temperatures And Calibration

    Figure 14.11 Alarm key which indicates the alarm condition 15 Surface temperatures and calibration The MIRI TL6 or MIRI TL12 multiroom IVF incubator temperature control system is ® ® described in more detail in this section. The MIRI TL6 multiroom IVF incubator is equipped with 6 completely separate PID ®...
  • Page 46 These items are placed in the MIRI TL12 multiroom IVF incubator menu, and they are ® named: T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12 T13, T14, T15, T16, T17, T18, T19, T20, T21, T22, T23 and T24. An overview of the areas associated with the sensor names is shown in the tables below.

  • Page 47: Pressure

    There is no crossover heating between the 12 compartments: This is a unique feature of the MIRI TL6 and MIRI TL12 multiroom IVF incubator. Lid ® ® temperature will, however, affect the bottom temperature in a compartment. The delta-T should always be 0.2 °C. Thus, if the bottom temperature is 37.0 °C, the lid should be 37.2 °C.

  • Page 48: Firmware

    17 Firmware The firmware installed on your MIRI TL6 and MIRI TL12 multiroom IVF incubator is ® ® upgradeable. Whenever an important update is available, it will be provided to our distributors around the world – they will ensure that your incubator runs with the newest available firmware.
  • Page 49 The recommended method to use the system is to fill a CultureCoin dish with 3 types of ® buffers in 3 of the wells (one type in each). Leave empty wells in between so there is no contact between the buffers. Fill the pH reservoir of the CultureCoin dish that is used for ®...

  • Page 50: Safe Sense Function

    When choosing an electrode (probe), it is necessary to consider the probe's size, as measurements will be made in a droplet. 19 Safe sense function There is a possibility to purchase the MIRI TL6 and MIRI TL12 multiroom IVF incubator ®...
  • Page 51 Figure 20.2 No active time-lapses view Figure 20.3 One active time-lapse view When a time-lapse is running normally, there will appear a green status indication in the main view. If the MIRI TL6 multiroom IVF incubators find the correct positions for the wells, the ®...

  • Page 52: Starting A Time-Lapse

    If the time-lapse is paused, the system will indicate "Suspended". Figure 20.5 Suspended time-lapse view A time-lapse may be suspended if, for instance, the dish is removed for a culture media change, manual observation or manipulation of the embryo. 20.1.1 Starting a time-lapse When the circle of an empty compartment in the main view is pressed, a time-lapse dialogue window will open.
  • Page 53 The 6 squares icons on the top left side in the display indicate compartment number. Select the correct patient from the list. Figure 20.7 Test patient selection view If no patient is sent from the MIRI TL6 or MIRI TL12 multiroom IVF incubator Viewer, ®...
  • Page 54 If the required network connection is interrupted, the following screen will appear: Figure 20.9 Network connection interruption view When the correct patient has been selected, the active positions in the CultureCoin must ® be selected (the wells that will contain an embryo). Positions 1 – 14 represent the 14 wells on the CultureCoin dish.

  • Page 55: Calibration Processes

    identify all the wells), place the CultureCoin in its place and secure its position by ® pushing it downwards and towards you, then to the left edge. Figure 20.11 Positioning CultureCoin in the compartment ® Press the "Start time-lapse" button. Now the time-lapse calibration will start. 20.1.2 Calibration processes Figure 20.12 Test patient calibration pending First, the screen will show the compartment view with the "Calibration pending"...
  • Page 56 During the calibration process, in the middle area it will indicate that the calibration process is active. Figure 20.13 Active automatic calibration process indication After the automatic calibration, it is necessary to pay attention to whether all the wells have been detected correctly. Manual calibration of a particular well must be done on LiveView Mode if not all well positions were detected/focused correctly, and some wells are marked with red/yellow/purple colour (see section 20.1.5).

  • Page 57: Compartment View

    Well that is marked in purple (Image mismatch) means there is image mis- match after the system comparing the last two images. This message could appear if the embryo moved too much than usual or an air bubble formed in the selected well.
  • Page 58 Resuming the time-lapse will initiate automatic calibration as the removal of the dish may cause parameters to shift. If the stop button is pressed, a confirmation dialogue will be displayed. Figure 20.16 Sleeping mode confirmation view To the left of the big circle, the focal planes are located. By taping on them, it is possible to move up and down in the focal planes.

  • Page 59: Settings

    Scrolling through the 6 compartments can be done with the arrow keys "LEFT" and "RIGHT". The circled arrow left in the top left-hand corner will take you back to the main view. If no time-lapse is running in the compartment, the screen will indicate that the compartment is empty.

  • Page 60: Manual Calibration Of The Well Position

    Press buttons corresponding to the desired choices. The cycle times cannot be set when a time-lapse has been started. End all time- lapses to adjust the cycle time. Figure 20.20 Changes are disabled while time-lapses are running 20.1.5 Manual calibration of the well position If the automatic calibration process failed, the LiveView mode might be used for manual adjustments and calibration.
  • Page 61 Figure 20.21 Confirmation dialogue view Figure 20.22 Suspended time-lapses view The black background indicates that there is no active time-lapse running in the compartment. The green background indicates that the time-lapse is running and is in regular operation. The red background indicates that there are calibration failures for some positions.
  • Page 62 Buttons in the top right corner offer the selection of the motor control, a square selection tool and an exposure time. Enter LiveView mode by pressing the microscope button marked red on the MIRI ® or MIRI TL12 multiroom IVF incubator screen. ®...
  • Page 63 Figure 20.26 Example of a correct well position in the camera view screen Figure 20.27 Example of an incorrect well position in the camera view screen If necessary, adjust the X-axis position with the "LEFT" or/and "RIGHT" arrows under the "Motor"...
  • Page 64 Figure 20.28 Well position adjustment instrument in the X-axis Make sure that your well/embryo is well focused (has good focus). If necessary, adjust the Z-axis position with the "UP" or/and "DOWN" arrows under the "Motor" icon (located in the upper right corner of the screen). Figure 20.29 Well position adjustment instrument in the Z-axis MIRI TL family`s multiroom IVF incubators User Manual Rev.
  • Page 65 Make sure that the well is inside the marked square limit, as shown below. Figure 20.30 Well position inside the marked square limit If the well position is out of the limit mark square, it could result in cropped images during Time-lapse. It could cause a system error, and the images of the well would not be taken.

  • Page 66: Alarms

    When the correct position and the desired focus are found and the set button is pressed, the system will confirm the user calibration. Figure 20.32 Correctly adjusted well’s view Manually overriding automatic features of the system should be done only in such cases when the system repeatedly fails to find the correct calibration.
  • Page 67 Figure 20.34 Lid opening alarm view Clear the alarm by pressing on the area – it will take you to the compartment view. Then either end the time-lapse, suspend, recalibrate or just confirm that the patient is still there. Figure 20.35 Compartment view after opening a lid The system will continue to generate time-lapse images after the lid is opened.
  • Page 68 Figure 20.36 Temperature alarm screen view Remove the dish immediately if temperature conditions become dangerous for the embryos. The compartments are entirely separate, so the dish can be safely moved to another position if the temperature in that particular compartment is stable.
  • Page 69 All incubation functions have level alarms indicated in the image by the relevant button turning red. All of the alarms can be seen in the alarm view, which displays the alarm history. concentration alarm view is shown in the picture below: Figure 20.38 CO concentration alarm view pressure alarm view is shown in the picture below:...

  • Page 70: Data-Logging Temperature View

    Figure 20.40 HDD full memory alert view 20.1.7 Data-logging temperature view Pressing the temperature button will change the view to temperature data graph view. Figure 20.41 Temperature data graph view The history view allows seeing temperature data graphs. It is possible to toggle on/off compartment graphs 1-6 in the MIRI TL6 multiroom IVF incubator and graphs 1-12 in ®...

  • Page 71: Data-Logging Co 2 View

    20.1.8 Data-logging CO view By pressing the "CO2" button, the view will change to the CO data graph view. The CO "Setpoint", "Concentration", "Flow" and "Pressure" graphs can be toggled on/off by pressing on them at the top of the display view. The period and zoom-in functions are the same as in the temperature view.

  • Page 72: Data-Logging Alarm View

    20.1.10 Data-logging alarm view By pressing the alarm bell, the alarm view opens up. The alarm view depicts all the parameters and any alarm statuses in a quick graphical overview. A red block represents each alarm – the longer the alarm lasts, the more that block increases in size. Figure 20.44 Alarm data view The "Lid"...

  • Page 73: Culturecoin

    21 CultureCoin ® The only dish used with MIRI TL6 and MIRI TL12 multiroom IVF incubators is the ® ® CultureCoin . The bottom of MIRI TL6 and MIRI TL12 multiroom IVF incubators ® ® ® compartments are shaped to fit the contour of the dish. There is only one way it can be put in the compartment, as the dish is not a perfect circle and has a flat side that makes it impossible to fit the dish in the compartment the wrong way.
  • Page 74 Each of the 14 wells is filled with approximately 25 µl culture medium. The washing wells can also be filled (approximately with 23 µl), but it is not a requirement. The embryo is placed at the bottom of the culturing area. Figure 21.3 Embryo Placement in detail on the 300µ...

  • Page 75: The Miri ® Tl Multiroom Ivf Incubators Viewer

    Figure 21.4 The culture wells are covered with a mineral oil layer, and the lid is put on A large reservoir outside the culturing area can be used for pH validation (please look at Figure 21.1). The reservoir can be closed with a gas permeable silicone plug which will stop evaporation.

  • Page 76: Cleaning Procedure Recommended By The Manufacturer

    The periodic cleaning procedure is recommended for routine processing and maintenance. The combination of periodic cleaning procedures and disinfection procedures is recommended for event-related concerns such as media spills, visual accumulation of soil and/or other contamination evidence. Also, it is recommended to clean and disinfect the MIRI TL6 or MIRI TL12 multiroom IVF incubator immediately...

  • Page 77: Temperature Validation

    Temperature conditions in the compartments can be continuously logged through the external connectors on the unit's side without compromising its performance. Any logging system that uses standard PT-1000 sensors may be used. Esco Medical can supply an external logging system (MIRI -GA12) for the sensors. ®...
  • Page 78 incubator may be validated by taking a gas sample from one of the 6 (MIRI TL6 model) ® or 12 (MIRI TL12 model) gas sample ports on the unit's side, using a suitable gas ® analyzer. Figure 24.1 PT-1000 Class B sensors in the MIRI TL6 multiroom IVF incubator ®...

  • Page 79: Alarm Switch For An External System

    Make sure that the gas analyzer is calibrated before use. 26 Alarm switch for an external system In order to connect the MIRI TL6 or MIRI TL12 multiroom IVF incubator to an external ® ® monitoring system and ensure maximum safety, especially during nights and weekends, the incubator is equipped with a 3.5 mm jack connector on the back, which can be connected to a monitoring device.

  • Page 80: Writing Area On The Compartment Lids

    Figure 26.2 “Open circuit” alarm mode Whenever the incubator’s power cord is disconnected from the power source, this switch will automatically indicate an alarm! It is an extra safety feature intended to alert the personnel in case of a power cut in the laboratory. 27 Writing area on the compartment lids Each compartment lid on the MIRI TL6 and MIRI...

  • Page 81: Emergency Procedures

    2. VOC/HEPA filters must be replaced every 3 months. 3. In-line HEPA filters must be replaced yearly during annual maintenance. 4. According to the intervals prescribed by the clinical practice in the laboratory where the MIRI TL6 or MIRI TL12 multiroom IVF incubator is in use, Suitable ®...
  • Page 82 • Alternatively, remove the samples from all the affected compartments and place them in an alternative or backup device that is not affected by the problem. If the CO level alarm goes off: There will be a 30-minute-long interval during which the user can assess if the condition is temporary or permanent.

  • Page 83: User Troubleshooting

    30 User troubleshooting Table 30.1 Heating system Symptom Cause Action The unit is switched off at the back or Switch on the device or connect to No heating, the display is off not connected to the power source the power source heating off, because,...
  • Page 84 Table 30.3 O gas regulator Symptom Cause Action No O gas regulation The system is not powered Check the power mains The system is on standby or switched Switch the system on Activate the O gas regulator by gas regulator is off setting “O2”...

  • Page 85: Specifications

    31 Specifications Table 31.1 The MIRI TL6 multiroom IVF incubator specifications ® Technical specifications MIRI ® Overall dimensions (W x D x H) 805 x 590 x 375 mm Weight 60 kg Material Mild steel/Aluminum/PET/Stainless steel Power supply 115V 60Hz OR 230V 50Hz Power consumption 330 W Temperature range...

  • Page 86: Electromagnetic Compatibility

    32 Electromagnetic compatibility Table 32.1 Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The MIRI TL6 and MIRI TL12 multiroom IVF incubators are intended for use in the electromagnetic ® ® environment specified below. The customer or the user of the MIRI TL6 or MIRI TL12 multiroom IVF ®...
  • Page 87 Guidance and manufacturer’s declaration – electromagnetic immunity The MIRI TL6 and MIRI TL12 multiroom IVF incubators are intended for use in the electromagnetic ® ® environment specified below. The customer or the user of the MIRI TL6 or MIRI TL12 multiroom IVF ®...
  • Page 88 Table 32.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and the MIRI TL6 or MIRI TL12 multiroom IVF incubators ® ® The MIRI TL6 and MIRI TL12 multiroom IVF incubators are intended to be used in an electromagnetic ®...

  • Page 89: The Validation Guide

    33 The Validation guide 33.1 Product release criteria The Esco Medical MIRI TL6 and MIRI TL12 multiroom IVF incubators undergo strict ® ® quality and performance testing before being released for sale. 33.1.1 Performance Each component used in the MIRI...

  • Page 90: Cosmetic

    In the following, we describe these tests and the equipment necessary to perform them. A test documentation form is also provided. A copy must be provided to Esco Medical for internal device tracking and device history record. 34.1 Mandatory equipment All equipment must be of high quality and calibrated.

  • Page 91: Recommended Additional Equipment

    • An O analyzer with a range of 0.0 – 20.0%. • A Pressure tester with a range of 0.0 – 1.0 bar. • A Multimeter. 34.2 Recommended additional equipment All equipment must be of high quality and calibrated. • A VOC meter able to measure the most common volatile organic compounds at least at the ppm level.

  • Page 92: About Co

    35.1.1 About CO Carbon dioxide (CO ) is a colourless, odourless, non-combustible gas. Carbon dioxide above the triple point temperature of -56.6 °C and below the critical point temperature of 31.1 °C can exist in both a gaseous and a liquid state. Bulk liquid carbon dioxide is commonly maintained as a refrigerated liquid and vapor at pressures between 1,230 kPa (approx.

  • Page 93: About N

    Measure the N concentration in the gas supply by routing the gas line into a bottle without a lid and a suitably large opening. Set the pressure/flow so that the bottle is flushed continually with gas, without increasing pressure in the bottle (i.e., the amount of gas exiting the bottle should be equal to the gas volume entering the bottle).

  • Page 94: N 2 Gas Pressure Check

    times. For safety, this unit has a built-in digital gas pressure sensor that monitors the incoming gas pressure and alerts the User if any drop is detected. Remove the inlet gas line for the CO gas. Attach the gas line to the gas pressure measuring device.

  • Page 95: O 2 Gas Concentration Check

    unit is used. Use sample port-6 for validation. Remember not to open any lid at least 15 min before starting the test nor during the testing itself. Hook up the gas analyzer inlet tube to the sample port. Make sure that the fit is perfect and that no air can enter or exit the system.

  • Page 96: Temperature Check: Compartment Lids

    At least 6 dishes prepared in advance (with at least one microdroplet of media approximately 10 – 100 µL in each dish). The media should be covered with a layer of Paraffin oil. The dishes do not need to be equilibrated, as the pH will not be measured during the validation tests.

  • Page 97: 6-Hour Stability Test

    If the N is not available, the test can be done without it. Make sure that the Esco Medical data logger software is running. Check that parameters are logged and give a meaningful reading. Let the device run without interfering for at least 6 hours. Analyse the results on the graphs.

  • Page 98: Cleaning

    • Let the incubator run empty for at least 20 minutes before inserting a sample. 35.12 Test documentation form The "Installation report" form must be completed with the tests-passed status filled by installation personnel and submitted to Esco Medical before the device is taken into clinical use. 35.13 Recommended additional testing 35.13.1 A VOC meter...

  • Page 99: A Laser Particle Counter

    36 Clinical use Congratulations! Your device is now ready for clinical use with the validation tests completed and the test report submitted to Esco Medical. It should provide many years of stable service. It is necessary to monitor the performance of the device continually.

  • Page 100: Co Gas Concentration Check

    Please refer to the "13.5.1.1 Temperature calibration" section for more information on how to perform the temperature calibration. PASS: • All temperatures measured on the bottom of the compartment in the loca- tions where the dishes would be placed must not deviate more than ± 0.2 °C from the setpoint.

  • Page 101: Co Gas Pressure Check

    IVF incubator will not be affected, as the gas in the compartment is not under pressure, and the reading is just an artifact based on unsuitable measuring equipment. Contact Esco Medical or the local distributor for further guidance. 36.4 CO...

  • Page 102: Ph Check

    User validation should be done as a minimum according to instructions given in the "33 The Validation guide" section. If problems are encountered, contact Esco Medical or your local representative. However, to sustain the high-performance level and avoid system errors, the owner is responsible for having a certified technician who performs components replacements according to table 37.1.

  • Page 103: Voc/Hepa Filter Capsule

    ® replaced every 3 months. Please follow these safety precautions when changing the VOC filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change filter every 3 months. • Failure to change the filter on time will result in low/no air-cleaning within the system.

  • Page 104: In-Line Hepa Filter For Co Gas

    CO regulator system. Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 105: Co Sensor

    This sensor's lifetime is more than 6 years, but for safety reasons, Esco Medical recommends the sensor to be replaced once every 4-years. Please follow these safety precautions when changing the sensor: •...

  • Page 106: Uv Light

    Always power off before removing any cover. Please follow these safety precautions when changing the UV-C light: • Always use an original UV-C light bulb (contact Esco Medical or your local distrib- utor for more details or ordering). • Change UV-C light bulb within 1 year from date of installation.

  • Page 107: Internal Gas Pump

    • Always use an original fan (contact Esco Medical or your local distributor for more details or ordering). • Change the fan within 3 years from the date of installation. • Failure to change the fan may cause the electronics to drift, resulting in low tem- perature and gas regulations.

  • Page 108: Gas Lines

    This sensor's lifetime is more than 3 years, but Esco Medical recommends the sensor to be replaced once every 2 years for safety reasons. Please follow these safety precautions when changing sensors: •...

  • Page 109: Internal 0.2Μ Filter For Co Gas

    CO regulator system. Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 110: Firmware Update

    • Warranty void if wrong/ non-original filter is used. Please refer to the service manual for replacement instructions. 37.15 Firmware update If Esco Medical has released a newer version of the firmware, this should be installed on the MIRI TL6 or MIRI TL12 multiroom IVF incubator during the yearly scheduled ®...

  • Page 111: Before Installation

    personnel clearly understand the instrument's functions, performance, testing, and maintenance. Installation personnel must be updated regarding alterations or additions to this document and the "Installation report" form. 38.2 Before installation 2 – 3 weeks before the installation due, the user/owner at the clinic is contacted via e- mail to plan the exact time to perform the installation.

  • Page 112: Bring The Following To The Installation Site

    38.4 Bring the following to the installation site • "Installation report" form. • Service manual for the MIRI TL6 or MIRI TL12 multiroom IVF incubator. ® ® • Updated service tool kit. • Memory stick with the latest released firmware & software. •...

  • Page 113: After The Installation

    When the installation trip is finished, a copy of the original "Installation report" form must be sent to Esco Medical Ltd. It will be saved with the device records. According to the ISO procedure and Medical Device Directive, a paper copy of the completed and signed installation test form is stored in the unique device's device history record.

This manual is also suitable for:

Miri tl6Miri tl12

Table of Contents