Esco Medical MIRI II-12 User Manual Download Page 6

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MIRI

II-12 Multiroom IVF incubators User Manual Rev. 4.0

Table of contents

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2 Safety warning

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3 Indication for use

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4 About the product

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5 Transport, Storage and Disposal

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5.1 Transportation requirements

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5.2 Storage and operation environment requirements

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5.2.1 Storage requirements

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5.2.2 Operation environment requirements

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5.3 Disposal

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6 Supplied service parts and accessories

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7 Safety symbols and labels

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8 Important safety instructions and warnings

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8.1 Before installation

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8.2 During installation

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8.3 Post installation

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9 Getting started

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10 Mains connection

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11 Gas connections

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12 HEPA/VOC filter

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12.1 Installation of a new filter capsule

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13 User interface

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13.1 Activating the heat and gas controls

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13.2 Temperature setpoint

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13.3 Changing the CO

concentration setpoint

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13.4 Changing the O

concentration setpoint

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13.5 System menu

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13.5.1 General menu page

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13.5.2 Calibration menu

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13.5.3 Temperature calibration menu

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13.5.4 CO

calibration menu

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Summary of Contents for MIRI II-12

Page 1: ...USER MANUAL Rev 4 0 Date of revised 06 10 2021 Rx only MIRI II 12 Multiroom IVF Incubators For research use only...

Page 2: ...uct is copyrighted and all rights are reserved by Esco Esco reserves the right to make periodic minor design changes without obligation to notify any person or entity of such change Sentinel is a regi...

Page 3: ...rtial refund credit the product must not have been damaged It must be returned complete meaning all manuals cables accessories etc within 30 days of original purchase in as new and resalable condition...

Page 4: ...ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and non serialized modules are not covered under this warranty This warranty gives you specific legal rights and you may have other rights...

Page 5: ...ill be required to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality Seal You should break this seal only after you have received factory authori...

Page 6: ...4 7 Safety symbols and labels 14 8 Important safety instructions and warnings 16 8 1 Before installation 16 8 2 During installation 16 8 3 Post installation 17 9 Getting started 17 10 Mains connection...

Page 7: ...es and measuring temperature 37 16 Pressure 39 16 1 CO2 gas pressure 39 16 2 N2 gas pressure 39 17 Firmware 40 18 pH measuring 40 19 SAFE Sense function 43 20 Data logging 43 20 1 Data logging tempera...

Page 8: ...4 Gas concentration levels and consumption 60 33 1 5 Cosmetic 61 34 Validation on site 61 34 1 Mandatory equipment 61 34 2 Recommended additional equipment 62 35 Testing 62 35 1 Gas supply CO2 62 35...

Page 9: ...37 3 In line HEPA filter for N2 gas 75 37 4 O2 sensor 75 37 5 CO2 sensor 76 37 6 UV light 77 37 7 Cooling fan 77 37 8 Internal gas pump 78 37 9 Proportional valves 78 37 10 Gas lines 78 37 11 Flow se...

Page 10: ...tions given in this documentation may damage the unit injure operating personnel and or poor equipment performance Any internal adjustment modification or maintenance to this equipment must be un dert...

Page 11: ...op and the bottom of each compartment is separated with a PET layer so that the lid temperature would not affect the bottom For validation purposes each compartment has a PT 1000 sensor built in The c...

Page 12: ...y performing this the manufacturer can provide a valuable service to the customers MIRI II 12 A pH sensor port is part of the DAQ package The user can plug any standard BNC pH probe to the unit and me...

Page 13: ...t the accompanying documents for important safety related information such as warnings and precautions that cannot be presented on the device itself for various reasons Do not use if the packing mater...

Page 14: ...ncubator to guide the user User labels are shown below Table 7 1 Packing box and electrical safety labels Description Image Packing box label 1 If stored longer than the shelf life the unit must be re...

Page 15: ...for use 7 Observe WEEE 8 Upper limit of temperature 9 Keep away from direct sunlight 10 Keep dry 11 Logo and serial number 12 Year of manufacture 13 Rx only 1 For research use only Table 7 3 Labels on...

Page 16: ...user manual thoroughly before use 3 Always keep these instructions easily accessible near the device 8 2 During installation 1 Never place this unit on top of other equipment that gives off heat 2 Pla...

Page 17: ...n or moisture or does not operate normally The MIRI II 12 multiroom IVF in cubators contain high voltage components that may be hazardous 3 Unplug this device during lightning storms or when unused fo...

Page 18: ...the manufacturer s recommended guidelines 10 Mains connection The MIRI II 12 multiroom IVF incubators come with a detachable mains power cord The power cord is prepared for the country in which the un...

Page 19: ...10 0 by infusing N2 gas 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 requir...

Page 20: ...reach the blastocyst stage 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 misca...

Page 21: ...d incorrectly will cause the unit to work not as intended This is dangerous The filter is removed by gently pulling it straight out using both hands Never run the MIRI II 12 multiroom IVF incubator if...

Page 22: ...come back on automatically after 5 min It can be muted again Display panel Shows the information about the current status of the unit The display consists of a 7 touchscreen display 13 1 Activating t...

Page 23: ...range from 25 0 C to 40 0 C The default temperature setpoint is 37 0 C To change the temperature setpoint please follow these instructions 1 Press one of the compartments boxes to change the temperatu...

Page 24: ...rature setpoint is set then the value will be applied to all compartments If the MULTI temperature setpoint is set it means that the compartments temperature values are individual for each compartment...

Page 25: ...ure below the setpoint for CO2 is chosen Figure 13 6 CO2 setpoint view 13 4 Changing the O2 concentration setpoint The O2 setpoint can be adjusted in the range from 5 0 to 10 0 The default O2 setpoint...

Page 26: ...igure 13 7 Main display view 2 Press or keys to adjust the O2 setpoint In the picture below the setpoint for O2 is chosen Figure 13 8 O2 setpoint view 3 Press the SETUP key in the O2 setpoint page to...

Page 27: ...nter 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...

Page 28: ...the 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...

Page 29: ...s shown below Figure 13 19 Calibration of the T1 zone temperature view In the above picture zone T1 is chosen Press or keys to calibrate T1 The same applies to other temperature zones Press the key at...

Page 30: ...overlay Place the dish in one of the designated spots indicated on the heating insert Proceed to validate if the lid temperature is precisely 0 2 C higher than the bottom temperature Stick a suitable...

Page 31: ...CO2 concentration was measured to be 6 4 By pressing the button three times it will take time to change the display s CO2 concentration value but the offset value will change immediately in this case...

Page 32: ...g mode page The running 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 setpoint is set then the valu...

Page 33: ...ich indicates the alarm condition The audio pattern is 3 short beeps followed by a 3 second pause All alarms have the same audio pattern 14 1 Temperature alarms All 12 compartments can trigger the tem...

Page 34: ...ture below the CO2 concentration is too low compared to the setpoint Figure 14 3 Low CO2 concentration alarm view on the main display The percentage of CO2 is too low CO2 concentration will appear in...

Page 35: ...by blinking red when the alarm is muted 14 3 Gas pressure alarms 14 3 1 CO2 pressure alarm If the CO2 gas supply is not attached correctly or incorrect CO2 gas pressure is applied to the system the MI...

Page 36: ...es above 0 7 bar 10 20 PSI it will trigger the alarm Figure 14 6 N2 gas pressure alarm view on the main display An audible alarm is also activated but it can be muted by pressing the alarm key If the...

Page 37: ...he alarm is muted 14 6 Loss of power alarm If the incubator s power is disconnected an audio alarm will go on for approximately 4 seconds and the LED in the mute alarm key will flash Figure 14 9 The a...

Page 38: ...tment 1 T1 T7 Compartment 2 T2 T8 Compartment 3 T3 T9 Compartment 4 T4 T10 Compartment 5 T5 T11 Compartment 6 T6 T12 Compartment 7 T13 T19 Compartment 8 T14 T20 Compartment 9 T15 T21 Compartment 10 T1...

Page 39: ...gas pressure The CO2 pressure can be seen in the CO2 box on the main page as shown below Figure 16 1 CO2 pressure on the main display The CO2 pressure value is shown in bar The external pressure must...

Page 40: ...ng to the maintenance plan 17 Firmware The firmware installed on your MIRI II 12 multiroom IVF incubator is upgradeable Whenever an important update is available it will be provided to our distributor...

Page 41: ...esponding to a measurement done with an external device Otherwise the measurement will be incorrect as pH is a temperature dependent measurement All readings from the pH system and calibration dialogu...

Page 42: ...system can still be used but with reduced accuracy The technique requires the user to be quick as the pH starts to shift very quickly once the lid is opened The optimal time to complete the procedure...

Page 43: ...probe When choosing an electrode probe it is necessary to consider the probe s size as measurements will be made on either a 4 well dish or a droplet 19 SAFE Sense function There is a possibility to...

Page 44: ...g a finger over it Zooming can be re peated in steps To get back to the original size press the Reset button 20 2 Data logging CO2 view By pressing the CO2 button the view will change to the CO2 graph...

Page 45: ...ize Figure 20 4 Temperature concentration and pressure alarm view The Lid section has 12 rows in the MIRI II 12 multiroom IVF incubator Each row indicates a single lid opening case in a particular com...

Page 46: ...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 spil...

Page 47: ...time spray sterile water on the surfaces and wipe them with a sterile wipe 6 Inspect the device if it is visually clean consider it ready for use If the device is visually not clean go to step 3 and...

Page 48: ...d designed for incubation of gametes and embryos with an overlay of either Paraffin or mineral oil The MIRI II 12 multiroom IVF incubator must not be irrigated Humidification of the MIRI II 12 multiro...

Page 49: ...m one of the 12 gas sample ports on the unit s side using a suitable gas analyzer Figure 25 1 Gas sample ports Each sample port is directly connected to the corresponding compartment with the same num...

Page 50: ...gases or if the power supply to the unit is suddenly cut the switch is indicating that the unit needs to be inspected by the user The connector can be connected either to a voltage source OR to a curr...

Page 51: ...ed for easy reference during the incubation process The text can be wiped off with a cloth afterward Use only a suitable non toxic pen that allows the text to be erased later and will not damage the i...

Page 52: ...29 Emergency procedures Total loss of power to or inside the unit Remove all the samples and place them in an alternative or backup device that is not affected by the problem Without the power source...

Page 53: ...porary and the CO2 level is low keep the lids shut If the state is temporary and the CO2 level is high open a few lids to vent out some CO2 If the O2 level alarm goes off Usually no emergency procedur...

Page 54: ...e power mains The system is switched off Switch the system on CO2 gas regulator is off Activate CO2 gas regulator by setting CO2 to ON in the menu No CO2 gas or wrong gas attached to CO2 gas input Che...

Page 55: ...ds N2 gas pressure indicated red on the display No wrong N2 gas pressure in the system Check the N2 gas supply ensure that the pressure is stable at 0 6 bar 8 70 PSI If O2 regulation is not needed set...

Page 56: ...consumption 500W Temperature range 25 0 40 0 C Gas consumption CO2 1 2 liters per hour Gas consumption N2 2 12 liters per hour CO2 range 3 0 10 0 O2 range 5 0 10 0 CO2 gas pressure input 0 4 0 6 bar...

Page 57: ...Voltage fluctuations flicker emissions IEC 61000 3 3 Class A Table 32 2 Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity The MIRI II 12 multiroom IVF incubator...

Page 58: ...rding to the equation applicable to the transmitter s frequency Recommended separation distance d 0 35 P d 0 35 P 80MHz to 800MHz d 0 7 P 800MHz to 2 5GHz Where P is the maximum the power output ratin...

Page 59: ...stance applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people Medical Devices may be a...

Page 60: ...sensor N2 concentration variation from setpoint within 0 2 absolute Pass IV Gas flow CO2 less than 2 l h Pass V Gas flow N2 less than 12 l h 33 1 2 Electrical safety An electric safety test is also ca...

Page 61: ...e most comprehensive tests before the device is shipped to the customer there is no way to be sure that everything is still OK at the location when the device is set up Therefore in keeping with estab...

Page 62: ...of 100 CO2 at 0 4 0 6 bar 5 80 8 70 PSI of pressure Measure the CO2 concentration in the gas supply by routing the gas line into a bottle without a lid and a suitably large opening Set the pressure f...

Page 63: ...v max Oxides of Nitrogen NO NO2 2 5 ppm v v max each The non volatile residue particulates 10 ppm w w max The non volatile organic residue oil and grease 5 ppm w w max Phosphine 0 3 ppm v v max Total...

Page 64: ...N2 gas can act as a simple asphyxiant by displacing air The User should make sure the N2 used is safe and moisture free Below is a list of some standard component concentrations Please note that the v...

Page 65: ...ing device PASS The value must be 0 4 0 6 bar Please refer to the User manual sections for more information 35 5 Voltage supply The voltage on site must be verified Measure the output plug on the UPS...

Page 66: ...nalyzer must have a gas return port connected to the multiroom IVF incubator i e another compartment Only measure while the value on the gas analyzer stabilizes Please refer to the 13 5 5 O2 calibrati...

Page 67: ...on PASS all temperatures measured on the bottom of the compartments where the dishes are located must not deviate more than 0 1 C from the setpoint 35 9 Temperature check Compartment lids The second p...

Page 68: ...st should be conducted with O2 regulation switched on and with N2 gas supply If the N2 is not available the test can be done without it Make sure that the Esco Medical data logger software is running...

Page 69: ...the incubator 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 f...

Page 70: ...ature check X CO2 gas concentration check X O2 gas concentration check X Check log for anomalies X CO2 gas pressure check X N2 gas pressure check X pH check X 36 1 Temperature check The temperature ch...

Page 71: ...ion It is essential to have a high precision gas analyzer for CO2 and O2 available to do the test Please follow these simple rules while testing gas concentration Check the O2 gas setpoint Check the a...

Page 72: ...re of 0 4 0 6 bar on the input N2 gas line This gas pressure must be held stable at any time For safety reasons this unit has a built in digital gas pressure sensor control that monitors the incoming...

Page 73: ...ons 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...

Page 74: ...acement In addition to the active carbon component this capsule also has an integrated HEPA filter inside enabling it to remove particles and volatile organic compounds from the air being re circulate...

Page 75: ...es found in the incoming N2 gas Failure to use the HEPA filter may cause damage to the high precision flow sensor calculate the amount of N2 gas entering the system and disturb the N2 regulator system...

Page 76: ...sensor within 1 year from the date of the previous sensor installation Failure to change the oxygen sensor on time will result in low no regulation of O2 concentration Warranty void if wrong non origi...

Page 77: ...ulb on time can result in contamination build up Warranty void if wrong non original UV light bulb is used Please refer to the service manual for replacement instructions 37 7 Cooling fan The cooling...

Page 78: ...s or breakdowns Warranty void if wrong non original pump is used Please refer to the service manual for replacement instructions 37 9 Proportional valves The internal valves make gas regulation possib...

Page 79: ...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 Alw...

Page 80: ...Always use the original filter contact Esco Medical or your local distributor for more details or ordering Change the filter once every year Failure to change the filter on time will result in low no...

Page 81: ...als who will perform installation repair and or maintenance of the instrument must be trained by Esco Medical or at a qualified training center Experienced service technicians or embryologists conduct...

Page 82: ...atest versions of firmware and data logging software Bring these files on a labeled memory stick to the service site 38 4 Bring the following to the installation site Installation report form Service...

Page 83: ...nd calibration of temperature 13 External measurement and calibration of gas concentration 14 How to add and remove a sample 15 Demonstrate how to replace the VOC HEPA filter can be found in the 12 1...

Page 84: ...n about this will be reported directly to QC or QA If the MIRI II 12 multiroom IVF incubator fails any of the Installation report form acceptance criteria or it in any way suffer from a severe error a...

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