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Rev. 1.0

Date of Revised 05.04.2021

Rx only

MIRI

®

TL family`s multiroom IVF

incubators

CE 0088

USER MANUAL

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Содержание MIRI TL 6

Страница 1: ...Rev 1 0 Date of Revised 05 04 2021 Rx only MIRI TL family s multiroom IVF incubators CE 0088 USER MANUAL...

Страница 2: ...is copyrighted and all rights are reserved by Esco Esco reserves the right to make periodic minor design changes without obligation to no tify any person or entity of such change Sentinel is a registe...

Страница 3: ...a partial 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 condi...

Страница 4: ...CAL 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 rig...

Страница 5: ...u will 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 auth...

Страница 6: ...rvice parts and accessories 15 7 Safety symbols and labels 16 8 Important safety instructions and warnings 19 8 1 Before installation 19 8 2 During installation 19 8 3 Post installation 19 9 Getting s...

Страница 7: ...atures and calibration 45 16 Pressure 47 16 1 CO2 gas pressure 47 16 2 N2 gas pressure 47 17 Firmware 48 18 pH measuring 48 19 Safe sense function 50 20 Screen functions 50 20 1 The main screen 50 20...

Страница 8: ...User troubleshooting 83 31 Specifications 85 32 Electromagnetic compatibility 86 33 The Validation guide 89 33 1 Product release criteria 89 33 1 1 Performance 89 33 1 2 Electrical safety 89 33 1 3 Co...

Страница 9: ...gas concentration check 100 36 4 CO2 gas pressure check 101 36 5 N2 gas pressure check 101 36 6 pH check 102 37 The Maintenance guide 102 37 1 VOC HEPA filter capsule 103 37 2 In line HEPA filter for...

Страница 10: ...Rev 1 0 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...

Страница 11: ...n or around this equipment should read this manual Failure to read understand and follow the instructions given in this documentation may damage the unit injure operating personnel and or poor equipme...

Страница 12: ...6 multiroom IVF incubator has 6 completely separate culture heat chambers whereas MIRI TL12 12 chambers Each chamber has its own heated lid and a room for one CultureCoin dish To ensure maximum perfor...

Страница 13: ...and the ability to write on the white lid with a pen The multiroom IVF incubator has been primarily developed and designed for incubation of gametes and embryos with an overlay of either Paraffin or m...

Страница 14: ...2 multiroom IVF incubator can be prepared for transport These labels should be glued on the box Label with handling symbols and the marked packing date Label with the product name and serial number 5...

Страница 15: ...ents except for the VOC HEPA and HEPA filters can be discarded as electrical waste after cleaning and disinfection Please note that the VOC HEPA and HEPA filters must be discarded following the applic...

Страница 16: ...perature between 20 C and 50 C 3 Keep away from direct sunlight 4 Caution consult the accompanying documents for important safety related information such as warn ings and precautions that cannot for...

Страница 17: ...uction 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 Table 7 3 Labels on the MIRI TL6 and...

Страница 18: ...ximum 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...

Страница 19: ...registers stoves or other apparatus that produce heat 8 Do not use this device near water sources 9 Use only 100 concentration CO2 and 100 concentration N2 gases 10 Always use an external HEPA filter...

Страница 20: ...afety instructions and warnings section 2 Connect the mains cable to the UPS 3 Connect the mains cable to the MIRI TL6 or MIRI TL12 multiroom IVF incubator 4 Connect gas lines 5 Set the gas pressure o...

Страница 21: ...atically adjusts to the correct mains power between 100V 240V AC 50 60 Hz Figure 10 1 Power supply 11 Gas connections There are two gas inlets on the back of the unit These ports are marked CO2 100 In...

Страница 22: ...n the gas line just before the inlet on the multiroom IVF incubator Notice the flow direction Connect the N2 inlet to the Nitrogen Bottle Figure 11 3 Gas filter 12 HEPA VOC filter VOCs are hydrocarbon...

Страница 23: ...fore entering the multiroom IVF incubator the gas is sent through the filter in a single pass Then upon return from the compartment the gas is filtered again The recirculation system constantly filter...

Страница 24: ...chapters the functions associated with keys and menu items will be ex plained User interface handles daily used functions and more advanced adjustments that might be made to the device The main keys a...

Страница 25: ...he 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 Compartme...

Страница 26: ...or 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 displ...

Страница 27: ...ture setpoint is 37 0 C In the MIRI TL6 multiroom IVF incubator the user can choose to set one common setpoint for all 6 compartments or set 6 independent temperature setpoints one for each compartmen...

Страница 28: ...tiroom IVF incubator 3 In the new window the user can choose the compartment for which he wants to set the setpoint To choose the compartment for which the setpoint value should be stated press the bu...

Страница 29: ...ture value will automatically be applied to other remaining compartments 13 3 CO2 setpoint The MIRI TL6 multiroom IVF incubator user interface images will be used as an example for all the CO2 setpoin...

Страница 30: ...Figure 13 13 Gas 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 13 4 O2 setpoint The MIRI TL6 multiroo...

Страница 31: ...r Press the Gas Setpoint button Figure 13 15 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...

Страница 32: ...bators 13 5 1 Calibration sub menu Press the Calibration button in the main menu view Calibration can be performed on temperature CO2 and O2 gases Figure 13 18 Calibration sub menu view in the MIRI TL...

Страница 33: ...n in the MIRI TL12 multiroom IVF incubator consists of two separate calibration zones Compartment 1 6 and Compartment 7 12 Figure 13 20 Calibration zones of Compartments 1 6 and Compartments 7 12 in t...

Страница 34: ...done using the UP and DOWN buttons Figure 13 23 Zone T1 calibration view in the MIRI TL6 and MIRI TL12 multiroom IVF incubators Each compartment has two internal temperature sensors One in the compar...

Страница 35: ...cated on the heating insert Proceed to validate if the lid temperature is precisely 0 2 C higher than the bottom temperature Stick a suitable calibrated sensor to the middle of the lid area and close...

Страница 36: ...ing this value the user can see how much the CO2 calibration value changed without delay Example how to calibrate O2 The real O2 concentration is measured with a suitable and calibrated device on one...

Страница 37: ...not be adjusted because this is the amount of CO2 gas put into the system while regulating The volume is shown in liters per hour It usually will fluctuate along with the CO2 regulation The CO2 pressu...

Страница 38: ...f Multi Temp SP is OFF it means that temperature values in compartments are combined Figure 13 27 Multi temperature setpoint view in the MIRI TL6 and MIRI TL12 multiroom IVF incubator When the desired...

Страница 39: ...o ON when the unit is being used 14 Alarms On fault condition the display will show the values in red An audio signal will go off but it can be muted by pressing the ALARM key once toggled on off for...

Страница 40: ...he setpoint The affected area s value will appear red on display Figure 14 2 High temperature alarm view on the main display in the MIRI TL6 multiroom IVF incubator In the picture below the temperatur...

Страница 41: ...deviates more than 1 from the set value Remember that changing the setpoint more than 1 from the current gas level will result in a CO2 level alarm It applies for all calibration adjustments In the p...

Страница 42: ...L6 multiroom IVF incubator If the mute key 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 key will sti...

Страница 43: ...TL6 or MIRI TL12 multiroom IVF incubator will go into N2 pressure alarm mode N2 pressure will be displayed in red indicating the wrong incoming gas pressure If the pressure falls below 0 3 bar 4 40 P...

Страница 44: ...ssure is incorrect and there is also a UV C light malfunction Figure 14 10 Multiple alarm view on the main display in the MIRI TL6 multiroom IVF incubator When there are multiple affected parameters a...

Страница 45: ...rolling the temperature in a particular area Each of the 6 available areas in the MIRI TL6 multiroom IVF incubator or 12 in MIRI TL12 multiroom IVF incubator are equipped with its separate temperature...

Страница 46: ...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 T16 T22 Compartment 11 T17 T...

Страница 47: ...that there is a pressure alarm on the pressure limits if the pressure falls below 0 3 bar or rises above 0 7 bar 4 40 10 20 PSI The internal pressure sensor cannot be calibrated by the user Under norm...

Страница 48: ...VF incubator are equipped with a high grade pH measuring system A standard male BNC connector is located in the back of the unit It can be connected to most standard pH combination probes Probes that...

Страница 49: ...th 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 is tested to be 15 seconds givi...

Страница 50: ...or the time lapse functions the data logging functions alarm overview and the pH measuring function The interaction with the screen is single click touch based Working lines from 1 6 are changed to 7...

Страница 51: ...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 w...

Страница 52: ...e When the circle of an empty compartment in the main view is pressed a time lapse dialogue window will open First select a patient from the list Patients can only be created or edited on the MIRI TL6...

Страница 53: ...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 the fo...

Страница 54: ...the CultureCoin dish will be used for the time lapse Any mistake made here will result in an empty well being photographed and no film made of the well containing the embryo The active position button...

Страница 55: ...ton 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 me...

Страница 56: ...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 Figure 20 14 Example of a failed automatic calibratio...

Страница 57: ...overview at a glance Figure 20 15 14 wells of the selected compartment The timeline around the large circle shows the elapsed time Video player buttons are located on the lower right side of the larg...

Страница 58: ...ot indicates the current level displayed The focal planes in all the images will shift at the same time When the system shows the Sleeping sign it means that the camera system generates images in anot...

Страница 59: ...indicate that the compartment is empty Figure 20 18 Empty time lapse view 20 1 4 Settings Pressing the Settings button in the main view will open a window where the number of focal planes and the tim...

Страница 60: ...on process failed the LiveView mode might be used for manual adjustments and calibration First try to adjust CultureCoin position and then rerun the automatic calibration The automatic search for the...

Страница 61: ...s that there are calibration failures for some positions When a compartment with an active time lapse is selected 14 dish positions will be shown at the bottom of the screen The white position backgro...

Страница 62: ...ator screen Figure 20 23 LiveView mode button on the main MIRI TL6 or MIRI TL12 multiroom IVF incubator screen In LiveView Mode select the required compartment from the compartment bar above and the r...

Страница 63: ...xample 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 RI...

Страница 64: ...tment 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...

Страница 65: ...would not be taken An inactive position can be activated by pressing the SET button X axis Z axis and square limit must be adjusted as noted above An active position can be deactivated by pressing the...

Страница 66: ...m repeatedly fails to find the correct calibration Since the user manually controls the motors in the LiveView it is possible to move the motors out of bounds and trigger mechanical limit switches Fig...

Страница 67: ...apse 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 opene...

Страница 68: ...able Remember to end an old time lapse and start the new at the changed position Loss of server connection is indicated at the bottom As long as the MIRI TL6 and MIRI TL12 multiroom IVF incubators hav...

Страница 69: ...h displays the alarm history CO2 concentration alarm view is shown in the picture below Figure 20 38 CO2 concentration alarm view CO2 pressure alarm view is shown in the picture below Figure 20 39 CO2...

Страница 70: ...ew 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 the MIRI TL12 multiroom IVF incubator pressin...

Страница 71: ...e top of the display view The period and zoom in functions are the same as in the temperature view Figure 20 42 CO2 data graph view 20 1 9 Data logging O2 view By pressing the O2 button the view will...

Страница 72: ...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 section has six rows in the MIRI TL6 multiroom IVF incubator whe...

Страница 73: ...ot a perfect circle and has a flat side that makes it impossible to fit the dish in the compartment the wrong way CultureCoin is a single use sterile class IIa medical device Figure 21 1 The CultureCo...

Страница 74: ...s easy because the wells are numbered Media and embryo handling are ergonomically optimized as it is possible to angle the pipette when loading the well Air bubbles in the media can be easily removed...

Страница 75: ...with them For more information please see User manual of MIRI TL family s multiroom IVF incubators Viewer Software 23 Cleaning instructions 23 1 Consideration about a sterile device The MIRI TL6 and M...

Страница 76: ...Inspect the device if it is visually clean consider it ready for use If the device is not visually clean repeat the process from step 1 23 3 Cleaning procedure recommended by the manufacturer Disinfe...

Страница 77: ...1000 Class B sensors in the MIRI TL12 multiroom IVF incubator These sensors serve external validation purposes They are completely separated from the circuit of the unit Temperature conditions in the...

Страница 78: ...IVF incubator Each sample port is directly connected to the corresponding compartment with the same number A gas sample will be taken ONLY from that specific compartment An external automatic gas sam...

Страница 79: ...pressure alarms for CO2 and N2 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...

Страница 80: ...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 incu...

Страница 81: ...sonnel 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...

Страница 82: ...temporary 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 proce...

Страница 83: ...ulator Symptom Cause Action No CO2 gas regulation The system is not powered Check the power mains The system is switched off Switch the system on CO2 gas regulator is off Activate CO2 gas regulator by...

Страница 84: ...ids 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 se...

Страница 85: ...ture gas concentration gas pressure Shelf life 1 year Use life 6 years Table 31 2 The MIRI TL12 multiroom IVF incubator specifications Technical specifications MIRI TL12 Overall dimensions W x D x H 9...

Страница 86: ...nity 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 cu...

Страница 87: ...GHz 3V m from 80MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the MIRI TL6 and MIRI TL12 multiroom IVF incubators including cables than the rec...

Страница 88: ...ximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output p...

Страница 89: ...n variation from setpoint within 0 2 absolute Pass IV Gas flow CO2 less than 2 l h Pass V Gas flow N2 less than 5 l h 33 1 2 Electrical safety An electric safety test is also carried out using a high...

Страница 90: ...ut outs 34 Validation on site Even though at Esco Medical we strive to do the most comprehensive tests before the device is shipped to the customer there is no way to be sure that everything is still...

Страница 91: ...ntain the correct CO2 concentration level in the MIRI TL6 or MIRI TL12 multiroom IVF incubator compartments the device must be connected to a stable source of 100 CO2 at 0 4 0 6 bar 5 80 8 70 PSI of p...

Страница 92: ...used is safe and moisture free Below is a list of some standard component concentrations Please note that the values given are NOT the proper amounts only an example Assay 99 9 v v min Moisture 50 pp...

Страница 93: ...e only 0 0 ppm v v Max is permissible 35 2 1 About N2 Nitrogen makes up a significant portion of the earth s atmosphere with 78 08 by volume Nitrogen is a colourless odourless tasteless non toxic and...

Страница 94: ...t be held stable at all 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 l...

Страница 95: ...on is checked for deviation The gas sample port on the side of the unit is used Use sample port 6 for validation Remember not to open any lid at least 10 min before starting the test nor during the te...

Страница 96: ...e Then close the lid and wait until the temperature has stabilized Be careful when closing the lid so as not to dislocate the sensor placement in the droplet Place the thermometer sensor on each zone...

Страница 97: ...losely as to the condition under which it will be running in clinical use If the preference of CO2 setpoint is 6 0 or temperature is different from the default setting an adjustment needs to be done b...

Страница 98: ...s in the same way Let the lids remain open for 5 minutes Wipe the 12 compartments and the heat optimization plates with a lint free cloth soaked in sterilized water Wipe the lids in the same way Let t...

Страница 99: ...l 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 continua...

Страница 100: ...e actual CO2 gas concentration to ensure the setpoint is reached and gas concentration is stabilized around the setpoint Remember not to open any lids for at least 10 min before starting the test or d...

Страница 101: ...or MIRI TL12 multiroom IVF incubator requires a pressure of 0 4 0 6 bar on the input CO2 gas line This gas pressure must be held stable at any time For safety reasons this unit has a built in digital...

Страница 102: ...ubator from Esco Medical contains high precision quality components These components are chosen to ensure the high durability and performance of the equipment However continual validation of the perfo...

Страница 103: ...cement 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 circulated...

Страница 104: ...s removes any particles 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 th...

Страница 105: ...ur local distributor for more details or ordering Change the O2 sensor within 1 year from the date of the previous sensor installa tion Failure to change the oxygen sensor on time will result in low n...

Страница 106: ...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 Failure to change the UV light bulb on time can result in c...

Страница 107: ...lways use an original gas pump contact Esco Medical or your local distributor for more details or ordering Change the gas pump within 2 years from the date of installation Failure to change the pump m...

Страница 108: ...imes or breakdowns Warranty void if wrong non original gas lines are used Please refer to the service manual for replacement instructions 37 11 Flow sensors The flow sensors are used by the CO2 N2 reg...

Страница 109: ...e round shape in line 0 2 HEPA filter for CO2 gas removes any particles found in the incoming CO2 gas Failure to use the HEPA filter may cause damage to the high precision flow sensor calculate the am...

Страница 110: ...ultiroom IVF incubator during the yearly scheduled service Please refer to the service manual for instructions on how to update the software 38 The Installation guide This section describes when and h...

Страница 111: ...lab must have an idle sturdy and stable lab bench for standing operation 2 The MIRI TL6 multiroom IVF incubator weight is approximately 60 kg and MIRI TL12 multiroom IVF incubator weight is approximat...

Страница 112: ...Switch on the MIRI TL6 or MIRI TL12 multiroom IVF incubator on the back 7 Observe for standard functionality 8 Let the unit warm up and stabilize for 30 min 9 Follow the guidelines in the 33 The Vali...

Страница 113: ...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 The date of installation is writte...

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