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Esco Medical MIRI II-12 User Manual

Multiroom ivf incubators
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USER MANUAL
MIRI
II-12 multiroom IVF incubators
®
Rev. 8.0
Revision Date 26/06/2024
Rx only

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  • Page 1 0123 USER MANUAL MIRI II-12 multiroom IVF incubators ® Rev. 8.0 Revision Date 26/06/2024 Rx only...

  • Page 2: Copyright Information

    Esco Medical Technologies, UAB Gamybos g. 2 • Ramuciai, Kauno r., 54468 Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com For Technical Service, contact: Europe Esco Medical Technologies, UAB Gamybos g. 2 • Ramuciai, Kauno r., 54468 Lithuania Tel +370 37 470 000 www.esco-medical.com •...
  • Page 3 If the medical device is delivered in good physical condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact your local sales representative or Esco Medical Technologies, UAB immediately. Standard Terms and Conditions Refunds &...
  • Page 4 Technologies, UAB ISO certification. Warranty and Product Support Esco Medical Technologies, UAB warrants this medical device to be free from defects in materials and workmanship under regular use and service for two (2) years from the original purchase date, provided the medical device is calibrated and maintained following this manual.
  • Page 5 Warranty Disclaimer If your medical device is serviced and/or calibrated by someone other than Esco Medical Technologies, UAB and their representatives, please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality Seal is removed or broken without proper factory authorization.

  • Page 6: Table Of Contents

    Table of contents 1 How to use this manual .......................... 11 2 Safety warning ............................11 3 Intended purpose/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 ............14 5.2.1 Storage requirements ......................
  • Page 7 13.5.5 O calibration menu ......................33 13.5.6 Operation mode menu ......................34 13.5.7 Localization menu......................... 34 14 Alarms ................................ 36 14.1 Temperature alarms ........................36 14.2 Gas concentration alarms ......................37 14.2.1 CO alarms ..........................37 14.2.2 O alarms ..........................38 14.3 Gas pressure alarms ........................
  • Page 8 23 Temperature validation ........................54 24 Gas concentration validation ......................54 25 Alarm switch for an external system ....................55 26 Writing area on the chamber lids ....................57 27 Maintenance ............................57 28 Emergency procedures ........................58 29 User troubleshooting ..........................60 30 Specifications............................
  • Page 9 34.12 Test documentation form ......................75 34.13 Recommended additional testing ..................75 34.13.1 A VOC meter.......................... 75 34.13.2 A laser particle counter ....................75 35 Clinical use ..............................76 35.1 Temperature check ........................76 35.2 CO gas concentration check ..................... 77 35.3 O gas concentration check ......................
  • Page 10 38 Other countries ............................89 38.1 Switzerland ............................89 39 Reporting on serious incidents ......................89 MIRI II-12 multiroom IVF incubators User Manual Rev. 8.0 ®...

  • 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: Intended Purpose/Use

    Used to direct attention to a specific item. WARNING Use caution. 3 Intended purpose/use The Esco Medical MIRI family’s multiroom IVF incubators are intended to be used to ® provide a stable culture environment at or near body temperature and CO premixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF) / assisted reproduction technology (ART) treatments.
  • Page 13 The multiroom IVF incubator has been primarily developed and designed for incubation of gametes and embryos with an overlay of either Paraffin or mineral oil. The multiroom IVF incubator has a built-in PC which operates the Esco Medical Data logger software for long-term data logging and data storage.

  • Page 14: Transport, Storage And Disposal

    Esco Medical MIRI family’s multiroom IVF incubators are used for in vitro fertilization ® (IVF) patients. Patients are women in their reproductive years who have fertility health issues. The intended target group indication is IVF treatment. There are no intended target group contraindications.

  • Page 15: Operation Environment Requirements

    • Do not use if the packing material is damaged. • Keep dry. Consult the accompanying documents for important safety-related information such as warnings and precautions that cannot be presented on the device itself for various reasons. 5.2.2 Operation environment requirements The device may only be used under the following conditions: •...

  • Page 16: Supplied Service Parts And Accessories

    6 Supplied service parts and accessories Service parts provided with the device are listed below: • 1 × VOC/HEPA filter capsule. • 2 × external 0.22µm HEPA filters for input gas supply. • 12 × heating optimization plates. • 1 × USB stick containing a PDF version of the user manual. •...
  • Page 17 Description Image 1. Consult instruction for use. 2. Warning on the back of the device indicates that an earth connection is needed and the mains information and an “ON/OFF” push button. 3. “Lightning bolt” indicates the potential risk of electrical shock (never remove any cover). Table 7.2 Device label Description Image...

  • Page 18: 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 Technologies, UAB or the local Representative. 2. Read the user manual thoroughly before use. 3. Always keep these instructions easily accessible near the device.

  • Page 19: During Installation

    8.2 During installation 1. Never place this device on top of other equipment that gives off heat. 2. Place this device on a flat, hard and stable surface. 3. Do not place the device on a carpet or similar surfaces. 4.

  • Page 20: Getting Started

    – 8.70 PSI). 11. Never use any other filter except those provided by Esco Medical Technologies, UAB. Otherwise, the warranty will be void. 12. Do not use the device without a proper Esco Medical Technologies, UAB VOC/HEPA filter attached. 9 Getting started...

  • Page 21: Gas Connections

    Do not defy 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. The power requirement is 230V 50Hz OR 115V 60Hz.

  • Page 22: Voc/Hepa Filter

    Figure 11.2 Pressure regulator Connect CO gas to the CO inlet with a suitable silicone tube. Ensure that the tube is fastened with a clip so that it does not accidentally loosen itself during a sudden pressure fluctuation. Use the supplied 0.22µm HEPA filter on the gas line just before the inlet on the multiroom IVF incubator.

  • Page 23: Installation Procedure Of A New Voc/Hepa Filter

    VOC levels in the 0.5 ppm range will typically allow an acceptable blastocyst development and reasonable pregnancy rates but will likely result in a high percentage of miscarriages. A combined VOC/HEPA filter (carbon filter) are integrated into the construction of the MIRI II-12 multiroom IVF incubator.

  • Page 24: User Interface

    Figure 12.3 Correctly installed VOC/HEPA filter A VOC/HEPA filter that has been installed incorrectly may cause gas leakage and contamination to appear in the incubator. The VOC/HEPA filter is removed by gently pulling it straight out using both hands (see Figure 12.2).

  • Page 25: Activating The Heat And Gas Controls

    Description Image Display panel Shows the information about the current status of the device. The display consists of a 7’’ touchscreen display. 13.1 Activating the heat and gas controls Heat and gas controls are activated using the "ON/OFF" switch in the rear of the incubator. Soon after system activation, the main display will alternate the reading between the following 4 parameters: Temperature...
  • Page 26 1. Press one of the chamber boxes to change the temperature setpoint: Figure 13.2 Main display view 2. Press (+) or (-) keys to adjust the temperature setpoint. In the picture below, the setpoint for chamber 1 is chosen. Figure 13.3 Setpoint for chamber 1 view Make sure to select the appropriate operation mode (SINGLE/MULTI).

  • Page 27: Changing The Co 2 Concentration Setpoint

    13.3 Changing the CO concentration setpoint The CO setpoint can be adjusted in the range from 3.0% to 10.0%. The default CO setpoint is 6.0%. To change the setpoint for CO concentration, please follow these instructions: 1. Press the CO box to change the CO concentration setpoint: Figure 13.5 Main display view...

  • Page 28: System Menu

    1. Press the O box to change the O concentration setpoint: Figure 13.7 Main display view 2. Press (+) or (-) keys to adjust the O setpoint. In the picture below, the setpoint for is chosen: Figure 13.8 O setpoint view 3.
  • Page 29 Figure 13.10 Setup key location view Press the RUNNING MODE key to enter the mode setting. The key is located on the left bottom side of the main display: Figure 13.11 Running mode key location on the main display Press the LOGGER key to enter the data logger. The key is located on the top of the main display: Figure 13.12 Logger key location on the main display Press the UV LAMP key to turn the UV lamp ON/OFF.

  • Page 30: General Menu Page

    top of the main display: Figure 13.15 Report export key location on the main display 13.5.1 General menu page Press the SETTINGS key to enter the general menu page. The key is located on the right top side of the main display: Figure 13.16 Setup key location view The general menu page is shown below: Figure 13.17 General menu view...

  • Page 31: Calibration Menu

    13.5.2 Calibration menu The calibration menu page is shown below: Figure 13.18 Calibration menu view Press the TEMPERATURE key to enter the temperature calibration page. Press the CO key to enter the CO calibration page. Press the O key to enter the O calibration page.

  • Page 32: Co Calibration Menu

    temperature by pushing (+) or (-) keys. Adjust the temperature by pressing the (+) key 5 times when T1 is chosen. The display will show the steps from 36.9 °C, 37.0 °C, 37.1 °C, 37.2 °C, 37.3 °C and 37.4 °C. The new value is now stored and T1 sensor calibration has been completed.

  • Page 33: O 2 Calibration Menu

    The offset value is displayed in the CO calibration window along with the CO concentration value. In this case, the real CO concentration was measured to be 6.4%. By pressing the "+" button three times, it will take time to change the display's CO concentration value, but the offset value will change immediately (in this case, the window will show 0.9 cal).

  • Page 34: Operation Mode Menu

    13.5.6 Operation mode menu The operation mode page is shown below: Figure 13.22 Operation mode page view 1. Choose between the SINGLE or MULTI temperature setpoint. If the "SINGLE" temperature operation mode is selected, the same setpoint will be applied to all chambers. On the other hand, if the "MULTI" temperature operation mode is selected, each chamber will have an individual temperature value.
  • Page 35 It is possible to change the language of the program using this menu. Usually, only the English language option will be available. To add more languages: 1. Click on the “+” button in the top right corner. This opens the “Languages” menu: Figure 13.24 Languages menu 2.

  • Page 36: Alarms

    Figure 13.26 Languages menu with native language option enabled 14 Alarms In the case of an alarm condition, alarm button and an audible alarm signal will turn on while the corresponding alarm(s) will be visible on the segment display matrix. An audio signal can be muted by pressing the alarm button once (muted ON/OFF for 5-minutes).

  • Page 37: Gas Concentration Alarms

    Figure 14.2 High-temperature alarm view on the main display If the mute button is pressed, the display will still show a red value and the sound will be muted for 5 minutes until the audio alarm goes off again. The mute alarm button will still show the alarm condition by blinking red when the alarm is muted.

  • Page 38: O 2 Alarms

    If the mute button is pressed, the display will still show a red value and the sound will be muted for 5 minutes until the audio alarm goes off again. The mute alarm button will still show the alarm condition by blinking red while the alarm is muted. Please refer to the “28 Emergency procedures"...

  • Page 39: Gas Pressure Alarms

    14.3 Gas pressure alarms 14.3.1 CO pressure alarm If the CO gas supply is not attached correctly or incorrect CO gas pressure is applied to the system, the MIRI II-12 multiroom IVF incubator will go into CO pressure alarm ® mode.

  • Page 40: Service Uvc Light

    The user should consult the distributor for further guidance or service inspection. The “UV” will disappear only when the UV-C light will be working again. Please contact your Esco Medical distributor for more details. 14.5 Multiple alarms In the picture below, in chamber 6 the temperature is too high, the CO...

  • Page 41: Loss Of Power Alarm

    Figure 14.8 Multiple alarm view on the main display When there are multiple affected parameters, all of them will appear red in the display. If the mute button is pressed, the display will show a red value and the sound will be muted for 5 minutes until the audio alarm goes off again.

  • Page 42: Alarm Verification

    How it is Alarm Alarm Alarm name Conditions determined group priority High- If the temperature rises above 0.5 °C High temperature from the SP. It is applicable for all Technical priority alarm chamber's bottom temperature alarm When the CO concentration drops by High Low CO 1% from the SP, after 3 min the alarm...

  • Page 43: Surface Temperatures And Measuring Temperature

    Alarm name How to verify an alarm When to verify an alarm Low incoming CO Disconnect the incoming CO pressure Low incoming N pressure Disconnect the incoming N 15 Surface temperatures and measuring temperature In this section, the MIRI II-12 multiroom IVF incubator temperature control system is ®...
  • Page 44 Area Bottom Chamber 7 Chamber 8 Chamber 9 Chamber 10 Chamber 11 Chamber 12 To calibrate temperature in a particular area, please find the corresponding sensor name and adjust it according to the measurement taken using a high-precision thermometer. Temperature calibration is done by adjusting the Tx (where x is the sensor number) according to the measurement done on the spot relevant to the dish placement.

  • Page 45: Pressure

    section of the User Manual. It may be necessary to do iterations before the zone is completely calibrated. The chambers 2 – 12 are adjusted/calibrated in a similar manner. The user may check the temperature inside the dish by placing the sensor inside the dish with media and mineral oil overlay.

  • Page 46: Gas Pressure

    16.2 N gas pressure The N pressure can be seen in the O box on the main page, as shown below. Figure 16.2 N pressure on the main display The N pressure value is shown in bar. The external pressure must be between 0.4 – 0.6 bar (5.80 –...
  • Page 47 system. A standard male BNC connector is located in the back of the device. It can be connected to most standard pH combination probes. Probes that require a separate reference cannot be used. According to the temperature level set in the calibration dialogue window on the screen, the system does temperature correction (ATC) according to the calibration dialogue window's temperature level.
  • Page 48 Before measuring in the culture media, calibrate the probe in the 3 buffers. Rinse the probe between each insertion. Figure 18.3 4-well dish with 3 buffers and media For calibration, at least two buffers are needed. However, we recommend using 3 buffers.

  • Page 49: Data-Logging

    Before measuring in the culture media, calibrate the probe in 2 or 3 buffers. It is necessary to rinse the probe between each insertion. After the calibration is performed and saved, quick pH measurement can be done in the culture media. Ensure the probe tip is well covered with media and that the opening through the test lid is sealed sufficiently to maintain gas levels (use tape or rubber seal).

  • Page 50: Data-Logging Co View

    It is possible to enlarge a particular area by dragging a finger over it. Zooming can be repeated in steps. To get back to the original size, press the “Reset” button. 19.2 Data-logging CO view By pressing the “CO ” button, the view will change to the CO graph.

  • Page 51: Data-Logging Alarm View

    19.4 Data-logging alarm view By pressing the alarm bell button, 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 19.4 Temperature, concentration and pressure alarm view The “Lid”...

  • Page 52: Manufacturer's Recommended Cleaning Procedure

    20.2 Manufacturer’s recommended cleaning procedure Always validate the cleaning procedures locally; for more guidance, consult either your manufacturer or the distributor. The routine cleaning procedure is recommended for regular processing and maintenance. The combination of standard cleaning procedures and disinfection procedures using alcohol-free detergents is recommended for event-related concerns such as media spills, visual accumulation of soil and/or other evidence of contamination.

  • Page 53: Heating Optimization Plates

    Use only the correct type of heating optimization plates for your dishes. Never incubate without the plates in place and never use non-Esco Medical heating optimization plates. This may cause dangerous and unpredictable temperature conditions that may be harmful to the specimens.

  • Page 54: Humidification

    Temperature conditions in the chambers can be continuously logged through the external connectors on the device'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 GA) for the sensors. ®...

  • Page 55: Alarm Switch For An External System

    validated by taking a gas sample from one of the 12 gas sample ports on the device's side, using a suitable gas analyzer. Figure 24.1 Gas sample ports Each sample port is directly connected to the corresponding chamber with the same number.
  • Page 56 The connector can be connected either to a voltage source OR to a current source. Note that if a current source is attached to the 3.5 mm jack connector, the maximum current rating is between 0-1.0 Amp. If a voltage source is attached, then the limitation is between 0 – 50V AC or DC. If there is no alarm, the switch within the device will be in the „ON“...

  • Page 57: Writing Area On The Chamber Lids

    26 Writing area on the chamber lids Each chamber’s lid on the MIRI II-12 multiroom IVF incubator is made from white glass, ® optimized for writing text. The patient data or the chamber's content can be noted for easy reference during the incubation process. The text can be wiped off with a cloth afterward.

  • Page 58: Emergency Procedures

    service and maintenance procedures are done not by trained and authorized personnel. 28 Emergency procedures Total loss of power to or inside the device: • Remove all the samples and place them in an alternative or backup device that is not affected by the problem;...
  • Page 59 If the CO pressure alarm goes off: • Inspect the external gas supply and gas supply lines. If the problem is external and not readily fixed, follow the guidelines under the “14.3.1 CO pressure alarm” section of the User Manual. If the N pressure alarm goes off: •...

  • Page 60: User Troubleshooting

    29 User troubleshooting Table 29.1 Heating system Symptom Cause Action The device is switched off at the back Switch on the device or connect to No heating, the display is off or not connected to the power source the power source Check the desired temperature No heating The temperature setpoint is incorrect...
  • Page 61 N2 gas input 0.6 bar of N gas is applied Check the O setpoint. If the issue The actual gas concentration is higher persists, contact Esco Medical than the setpoint support Lid(s) are left open Close the lid(s) Poor O...

  • Page 62: Specifications

    30 Specifications Table 30.1 MIRI II-12 multiroom IVF incubator’s specifications ® Technical specifications MIRI II-12 ® Overall dimensions (W × × 740 × 575 × 215 mm Weight 47 kg Material Mild steel / Aluminum / PET / Stainless steel Power supply 115V 60Hz or 230V 50Hz Power consumption...

  • Page 63: Electromagnetic Compatibility

    31 Electromagnetic compatibility Table 31.1 Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The MIRI II-12 multiroom IVF incubators are intended for use in the electromagnetic environment ® specified below. The customer or the user of the MIRI II-12 multiroom IVF incubator should ensure that it is ®...
  • Page 64 Power frequency The power-frequency magnetic (50/60 Hz) fields' levels should Performance magnetic field 3 A/m characteristic specific location in a typical commercial IEC 61000-4-8 or hospital environment Guidance and manufacturer’s declaration – electromagnetic immunity The MIRI II-12 multiroom IVF incubators are intended for use in the electromagnetic environment ®...
  • Page 65 Table 31.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and the MIRI II-12 multiroom IVF incubators ® The MIRI II-12 multiroom IVF incubators are intended to be used in an electromagnetic environment in ® which radiated RF disturbances are controlled.

  • Page 66: Validation Guide

    32 Validation guide 32.1 Product release criteria The Esco Medical MIRI II-12 multiroom IVF incubator undergoes strict quality and ® performance testing before being released for sale. 32.1.1 Performance Each component used in the MIRI II-12 multiroom IVF incubator is tested during the ®...

  • Page 67: Visual Inspection

    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 Technologies, UAB for internal device tracking and device history record.

  • Page 68: Recommended Additional Equipment

    • A CO analyzer with a minimum range of 0.0 – 10.0%. • An O analyzer with a minimum range of 0.0 – 20.0%. • A Pressure tester with a minimum range of 0.0 – 1.0 bar. • A Multimeter. 33.2 Recommended additional equipment All equipment must be of high quality and calibrated.

  • Page 69: About Co

    34.1.1 About CO Carbon dioxide (CO ) is a colorless, odorless, 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 70: Gas Supply N

    34.2 Gas supply N In order for the regulation system to maintain the correct O concentration levels in the MIRI II-12 multiroom IVF incubator chambers, the device must be connected to a stable ® supply of 100% N at 0.4 – 0.6 bar (5.80 – 8.70 PSI) of pressure. Measure the N concentration in the gas supply by routing the gas line into a bottle without a lid and a suitably large opening.

  • Page 71: Co Gas Pressure Check

    • Water (H 0) 0.5 ppm. 34.3 CO gas pressure check The MIRI II-12 multiroom IVF incubator requires a pressure of 0.4 – 0.6 bar (5.80 – 8.70 ® PSI) on the input CO gas line. This gas pressure must always be held stable. For safety, this device has built-in digital gas pressure sensor that monitors the incoming gas pressure and alerts the user if the pressure drops below 0.3 bar.

  • Page 72: Co Gas Concentration Check

    34.6 CO gas concentration check The CO gas concentration is checked for deviation. The gas sample port on the side of the device 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.

  • Page 73: Temperature Check: Chamber Bottoms

    34.8 Temperature check: chamber bottoms The first part of the temperature check is performed using a thermometer with a sensor suitable for measuring temperature in a droplet of media covered with Paraffin oil, with a resolution of 0.1 °C as a minimum. At least 12 dishes prepared in advance (with at least one microdroplet of media approximately 10 –...

  • Page 74: 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 parameter are logged and give a meaningful reading. Let the device run without interfering for at least 6 hours. Analyze the results on the graphs.

  • Page 75: Cleaning

    34.12 Test documentation form The "Installation report" form must be completed with the tests-passed status filled by installation personnel and submitted to Esco Medical Technologies, UAB before the device is taken into clinical use. 34.13 Recommended additional testing 34.13.1 A VOC meter...

  • Page 76: Clinical Use

    35 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 is necessary to monitor the performance of the device continuously. Use the below scheme for in-use validation.

  • Page 77: Co Gas Concentration Check

    35.2 CO gas concentration check The CO gas concentration is checked for deviations. The gas sample port on the side of the device is used for this. Use sample port-6 for validation. It is essential to have a high- precision gas analyzer for CO and O available to do the test.

  • Page 78: Co Gas Pressure Check

    II-12 multiroom IVF incubator ® will not be affected, as the gas in the chamber 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. 35.4 CO...

  • Page 79: Maintenance Guide

    User validation should be done as a minimum according to instructions given in the "33 Validation guide" section of the User Manual. If problems are encountered, contact Esco Medical Technologies, UAB or your local representative. However, to sustain the high-performance concentration and avoid system errors, the owner is responsible for having a certified technician who performs components replacements according to table 36.1.

  • Page 80: Voc/Hepa Filter Capsule

    IVF incubator must be replaced every 3 months. Please follow these safety precautions when changing the VOC/HEPA filter: • Always use the original filter (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Change filter every 3 months.

  • Page 81: Internal In-Line 0.2Μm Hepa Filter For Incoming Co And N Gas

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

  • Page 82: 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 83: Cooling Fan

    Always power the device 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 Technologies, UAB or your local distributor for more details or ordering).

  • Page 84: Internal Gas Pump

    Please follow these safety precautions when changing the internal gas pump: • Always use an original gas pump (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Change the gas pump within 2 years from the date of installation.

  • Page 85: Flow Sensors

    Please follow these safety precautions when changing gas lines: • Always use original gas lines (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Failure to change the gas lines may cause slow recovery times or breakdowns.

  • Page 86: Firmware Update

    • Warranty void if wrong/non-original regulators are used. Please refer to the service manual for replacement instructions. 36.13 Firmware update If Esco Medical has released a newer version of the firmware, it should be installed on the MIRI II-12 multiroom IVF incubator during the yearly scheduled service.

  • Page 87: Preparing For Installation

    The clinic must be informed about the site requirements before installation and should have signed the customer requirement checklist: 1. The lab must have an idle sturdy and stable lab bench for standing operation. 2. The MIRI II-12 multiroom IVF incubator weight is approximately 45 kg. ®...

  • Page 88: User Training

    When the installation trip is finished, a copy of the original "Installation report" form must be sent to Esco Medical Technologies, UAB. 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.

  • Page 89: Other Countries

    In case of any serious incidents that have occurred in relation to the device should be reported to Esco Medical Technologies, UAB by contacts, written on the contact information page, and the Authorised Representative in which the user and/or patient is established.

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