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Mini MIRI

® 

Dry and Mini MIRI

® 

Humidity Multiroom IVF incubators User Manual 

Rev. 3.0 

86

 

 

4.

 

Gas regulation on/off. 

5.

 

Setpoint for temperature, CO

2

 and O

2

. 

6.

 

Explain how N

2

 is used to suppress the O

2

 level. 

7.

 

Alarm turn off procedure (temperature, CO

2

, O

2

) and revert times. 

8.

 

Insertion and removal of heating inserts from the Mini MIRI

®

 Dry and Mini MIRI

®

 

Humidity multiroom IVF incubator. 

9.

 

How to toggle the "Oil culture" and "Open culture" modes, and when which mode 
should be used. 

10.

 

Emergency procedures (can be found in the "29 Emergency Procedures" section). 

11.

 

Explain how to clean the device and heating inserts. 

12.

 

External measurement and calibration of temperature. 

13.

 

External measurement and calibration of gas concentration (InControl or Galaxy). 

14.

 

How to add and remove a sample. 

15.

 

Demonstrate how to replace the VOC-HEPA filter (can be found in the "12.1 Instal-
lation of new filter capsule" section). Not applicable in the Mini MIRI

®

 Humidity 

multiroom IVF incubator. 

16.

 

Datalogger functionality, how to establish a connection and re-connection. 

 

 

Use  the  User  manual  section  as  much  as  possible  to  get  the  User  well  ac-

quainted with it.  

 

 

The user/owner is informed that the first VOC filter change is 3 months after 

installation and 3-month intervals. The first service check is under normal circum-
stances after 1 year.

 

38.7 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. The 
date of installation is written in the instrument overview file. The date of installation is 
also written in the service schedule.  
 
Suppose the Mini MIRI

®

 Dry or Mini MIRI

®

 Humidity multiroom IVF incubator user or 

owner make inquiries about a written "Installation report". The completed and signed 
"Installation report" form must be sent to the clinic. Any deviations/complaints/sugges-
tions from the Installation visit are reported in the CAPA system. If a critical error has 
occurred, information about this will be reported directly to QC or QA. 
 

Содержание Mini MIRI Dry

Страница 1: ...Rev 3 0 Date revised 05 06 2021 Rx only Mini MIRI Dry and Mini MIRI Humidity Multiroom IVF incubators CE 0088 USER MANUAL...

Страница 2: ...ying product 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...

Страница 3: ...must not have been dam aged It must be returned complete meaning all manuals cables accessories etc within 30 days of original purchase in as new and resalable condition The Return Procedure must be f...

Страница 4: ...RANTY 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 which vary from province to provin...

Страница 5: ...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 You should break this seal only after you have received factory a...

Страница 6: ...vice parts and accessories 15 7 Safety symbols and labels 16 8 Important safety instructions and warnings 18 8 1 Before installation 18 8 2 During installation 18 8 3 Post installation 19 9 Getting st...

Страница 7: ...the Mini MIRI Dry model 39 15 6 Loss of power alarm 39 16 Changing the set points 40 16 1 The temperature set point 40 16 2 The CO2 gas concentration set point 40 16 3 The O2 gas concentration set poi...

Страница 8: ...release criteria 61 33 1 1 Performance 61 33 1 2 Electrical safety 61 33 1 3 Communication data logging 61 33 1 4 Gas concentration levels and consumption 61 33 1 5 Cosmetic 62 34 Validation on site...

Страница 9: ...IRI model 75 37 2 Humidification bottle applicable only for the Mini MIRI Humidity model 76 37 3 In line HEPA filter for CO2 gas 76 37 4 In line HEPA filter for N2 gas 77 37 5 O2 sensor 77 37 6 CO2 se...

Страница 10: ...Mini MIRI Humidity Multiroom IVF incubators User Manual Rev 3 0 10 38 4 Bring the following to the installation site 85 38 5 Installation procedure at the site 85 38 6 User training 85 38 7 After the...

Страница 11: ...ith on or around this equipment should read this manual Fail ure to read understand and follow the instructions given in this documentation may result in damage to the unit injury to the operating per...

Страница 12: ...idity capacity for 35 mm Petri dish is 16 pcs And for 60 mm and 4 well Petri dishes 8 pcs To ensure maximum performance the system of Mini MIRI Dry and Mini MIRI Humid ity multiroom IVF incubators hav...

Страница 13: ...2 in use For safety reasons the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator has a very complete gas control system that consists of pressure regulator preventing dangerous gas pressur...

Страница 14: ...d to in Regulation EU NO 722 2012 5 Transport Storage and Disposal 5 1 Transportation requirements The device is packed in a carton box and it is wrapped in polyethylene The box is affixed to a pallet...

Страница 15: ...minated The unit contains reusable materials All components except for the VOC HEPA and HEPA filters can be discarded as electrical waste after cleaning and disinfection Please note that the VOC HEPA...

Страница 16: ...be returned to the manufacturer for a new release test 2 Shipping temperature between 20 C and 50 C 3 Keep away from direct sunlight 4 Caution consult the accompanying documents for important safety r...

Страница 17: ...erve 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 2 Info labels on Mini MIRI Dry and Mini MIRI Hum...

Страница 18: ...ves off heat 2 Place this unit on a flat hard and stable surface 3 Do not place the unit on a carpet or similar surfaces 4 Do not defeat the safety purpose of the grounding type earthing plug 5 A grou...

Страница 19: ...ms or when unused for an extended pe riod of time 4 Protect the power cord from being walked on or pinched particularly at the plug convenience receptacles and the point where it exits from the appara...

Страница 20: ...sterile or in a clin ically acceptable cleanliness state Consult the cleaning instructions section in this manual for the manufacturer s recommended guidelines 10 Mains connection The Mini MIRI Dry an...

Страница 21: ...e O2 control in the compartments is available in the range from 3 9 19 9 by infusing N2 The premixed gas inlet should be connected to the CO2 inlet The inlet s gas pressure should be between 0 4 0 6 b...

Страница 22: ...isopropanol benzene hexane formalde hyde vinyl chloride VOCs can also occur in medical gases such as CO2 and N2 It is essential to use in line VOC filters to prevent these fumes from entering your Mi...

Страница 23: ...and VOC filter are mounted on the device s back to ease access and replacement 12 1 Installation of new filter capsule Two blue caps that are installed on the filter can be discarded during unwrapping...

Страница 24: ...ser interface handles daily used functions and more advanced adjustments that might be made to the device The main keys and their purpose are presented in table 13 1 Table 13 1 Main keys and their pur...

Страница 25: ...ncentration in O2 Mode O2 concentration in Open Oil Culture 13 2 System menu Press and hold the rotatory button for 3 seconds to access the menu Navigate in the menu by Rotating rotatory button clockw...

Страница 26: ...re is the first category when the user enters the menu Press the rotatory button to enter the Temperature sub menu Rotate the rotatory button to scroll further down in the menu Press the rotatory butt...

Страница 27: ...rs One in the compart ment lid and another in the compartment bottom Example how to calibrate the temperature The temperature has to be measured with a suitable and calibrated device With a quality th...

Страница 28: ...ssing the rotatory button and rotating it or The default status for the CO2 control is OFF Move to the next CO2 sub menu item with rotation or one step up with rotation CO2 flow rate is shown it canno...

Страница 29: ...isplay shows 6 0 6 1 6 2 6 3 and 6 4 When CO2 equals measured CO2 press the rotatory button The new value is stored and the CO2 sensor calibration has been modified Pure CO2 100 gas recovery till 5 is...

Страница 30: ...g with the O2 regulation Move to the next O2 sub menu item with rotation or one step up with rotation N2 internal pressure rate is shown it cannot be adjusted on the Mini MIRI Dry and Mini MIRI Humidi...

Страница 31: ...pling outlet s measurement by an external reliable O2 measurement device Calibration values should only be changed by a trained user or the technician according to specific measurements Done with the...

Страница 32: ...emixed gas with higher gradation than the setpoint For example if you need to achieve a 5 CO2 gas setpoint premixed gas should have 6 CO2 in its mixture Then exit the menu by or press the rotatory but...

Страница 33: ...ual s safety instructions and warnings section Instead of connecting Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubators to either only 100 CO2 or both 100 CO2 and 100 N2 the incubator is at...

Страница 34: ...Move to the next service sub menu item with rotation or one step up with rotation The display will show the GAS function Press the rotatory button to enter the service sub menu and rotate or to choos...

Страница 35: ...higher from the values they expect If they try to change the setpoint or the calibration to get rid of the offset the regulation will not work 2 They cannot set the setpoints they would typically do w...

Страница 36: ...on adjustments The number will indicate the zone triggering the alarm following A Temperature is too high in compartment 2 Temperature is too low in compartment 1 The display will lock on the alarm co...

Страница 37: ...ration adjustments CO2 gas is too low CO2 gas is too high The display will lock on the alarm condition and will stop alternating between the stand ard status messages If the mute key is pressed the di...

Страница 38: ...hich indicates an in correct incoming gas pressure If the pressure falls below 0 3 bar 4 40 PSI or rises above 0 7 bar 10 20 PSI it will trigger the alarm P stands for pressure The display will lock o...

Страница 39: ...nd then the alarm conditions The flow will be forced according to the alarms The temperature alarms have 1st priority gas level alarms 2nd and gas pressure 3rd 15 5 Alarm UVC light applicable only for...

Страница 40: ...set point If the display does not show the current temperature reading rotatory button rotation or will toggle between the temperature CO2 O2 and mode readings 16 2 The CO2 gas concentration set point...

Страница 41: ...tton rotation or will toggle between the temperature CO2 O2 and mode readings 16 4 The culture mode The culture mode can be set for under oil culture or open culture Under oil culture mode is used whe...

Страница 42: ...is designed not for embryo culturing but if there is a need for media equilibration Do not use open culture mode longer than 4 h Media volume should be not less than 0 8 mL in 4 well dishes If the me...

Страница 43: ...e dish place ment After temperature adjustment give it at least 15 minutes for the temperature to stabilize use the thermometer to verify the correct temperature on each area Be careful when changing...

Страница 44: ...ry to do iterations before the zone is completely calibrated The 2nd compartment is adjusted calibrated in the same manner 18 Pressure 18 1 CO2 gas pressure The CO2 pressure can be read out in the CO2...

Страница 45: ...distributors around the world they will make sure that your Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator runs with the newest available firmware A service technician can do this durin...

Страница 46: ...A removable heat optimization plate can be removed and cleaned cannot be au toclaved As this serves as the main holding area for samples this should be the highest priority to keep clean Compartments...

Страница 47: ...er off the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator rear panel 2 Open the lids 3 Use the required disinfectant to disinfect the internal surface and a glass plate on the lid s top U...

Страница 48: ...n overlay Set the culture mode for Oil culture It cannot be used for open culture mode The Mini MIRI Dry multiroom IVF incubator must not be irrigated Humidification of the Mini MIRI Dry multiroom IVF...

Страница 49: ...ly covered with the lid that comes with the dish The Mini MIRI Humidity multiroom IVF incubator maintains humidity level circulating gas in the system through water in the humidification bottle In oth...

Страница 50: ...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 number The gas sample will be taken ONLY from the...

Страница 51: ...be inspected by the user 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 max imum current ra...

Страница 52: ...is made from white glass optimized for writing text The compartment s patient data or content can be noted down for easy reference during the incubation process The text can be wiped off with a cloth...

Страница 53: ...ients or users Warranty is considered to be void if service and maintenance are not fol lowed Warranty is considered void if service and maintenance procedures are done not by trained and authorized p...

Страница 54: ...m If the condi tion is 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 Usu...

Страница 55: ...lation The system is not powered Check power mains The system is on standby or switched off Switch the system on CO2 gas regulator is off Activate CO2 gas regulator by setting CO2 to ON in the menu No...

Страница 56: ...ds N2 P is shown on the dis play No wrong N2 gas pressure to the system Check N2 gas supply and ensure that pressure is stable at 0 4 0 6 bar 5 80 8 70 PSI If O2 regulation is not needed set the O2 to...

Страница 57: ...ature gas concentration and gas pressure Shelf life 1 year Use life 6 years Table 31 1 Mini MIRI Humidity multiroom IVF incubator specifications Technical specifications Mini MIRI Humidity Overall dim...

Страница 58: ...onic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Class A Table 32 2 Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity T...

Страница 59: ...t guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 10 Vrms 150kHz to 80 MHz in ISM bands 3 V m 80 MHz to 2 5 GHz 3V m from 80MHz to 2 5 GHz Portable and mobile RF communica tions equipmen...

Страница 60: ...ed at a maximum output power not listed above the recommended separation dis tance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maxim...

Страница 61: ...bso lute Pass III Internal sensor N2 concentration variation from setpoint within 0 2 absolute Pass IV Gas flow CO2 less than 2 l h for Mini MIRI Humidity model less than 4 l h Pass V Gas flow N2 less...

Страница 62: ...33 1 5 Cosmetic No misalignment in the lids Each lid should be opened and closed easily The seals for the lids must be appropriately attached and aligned No scratches or missing paint on the cabinet...

Страница 63: ...I Humidity mul tiroom IVF incubator with the laser particle counter The reading should be noted down as the background particle level Recommended additional equipment can be used for further installat...

Страница 64: ...approx 25 bar Carbon dioxide may also exist as a white opaque solid with a temperature of 78 5 C under at mospheric pressure A high concentration of carbon dioxide 10 0 or more can asphyxiate quickly...

Страница 65: ...he gas volume entering the bottle Sample from the bottle near the bottom with the gas analyzer A gas analyzer that can measure 0 O2 accurately can be used 100 N2 0 O2 PASS N2 concentration measured mu...

Страница 66: ...for the CO2 gas Attach the gas line to the gas pressure measuring device PASS The value must be 0 4 0 6 bar Please refer to the 18 1 CO2 gas pressure section for more information 35 4 N2 gas pressure...

Страница 67: ...t the fit is perfect and that no air can enter or exit the system The gas analyzer must have a gas return port connected to the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator i e another...

Страница 68: ...ibrated as the pH will not be measured during the vali dation tests The dishes are placed with at least one dish in each compartment The dishes should be placed on the corresponding size slot on the h...

Страница 69: ...is kept small and the tape used is strong thin and light Place the thermometer on each zone and verify the temperature Pass all temperatures measured on the compartments lid must not deviate more tha...

Страница 70: ...del less than 4 l h Pass V Gas flow N2 less than 8 l h for Mini MIRI Humidity model less than 12 l h 35 11 Cleaning Always validate the cleaning procedures locally or consult the manufacturer or the d...

Страница 71: ...oom IVF incubator with the VOC meter The reading should be noted down as the back ground VOC level Then a sample is taken from the gas sample port number 2 Pass 0 0 ppm VOC Ensure that the sample line...

Страница 72: ...re 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 th...

Страница 73: ...starting the test or dur ing the testing itself Please refer to the 13 4 3 O2 sub menu section for more information on how to perform the O2 gas calibration PASS O2 concentration measured must not de...

Страница 74: ...incoming gas pressure and alerts the user if any drop is detected It is recommended to check the N2 gas pressure in the menu by inspecting the value for an item called N2 P N2 pressure PASS The value...

Страница 75: ...Humidification Bottle6 X HEPA in line filter for CO2 gas X HEPA in line filter for N2 gas X O2 sensor X CO2 sensor X UV light5 X Cooling fan X Internal gas pump5 X Pump module6 X Proportional valves...

Страница 76: ...dity model A humidification bottle contains water that is used to maintain the humidity in the cham ber It should be changed each month Water in the humidification bottle must be changed at least once...

Страница 77: ...p the O2 gas concentration at a de sired level inside the chambers The lifetime of this sensor is limited due to its construc tion From the day the sensor is unpacked a chemical process is activated w...

Страница 78: ...desired level This sensor s lifetime is more than 6 years but for safety reasons Esco Medical recom mends the sensor to be replaced once every 4 years Please follow these safety precautions when chang...

Страница 79: ...placement instructions 37 8 Cooling fan The cooling fan is responsible for cooling down the electronics installed in the unit A breakdown of the cooling fan will stress the components due to temperatu...

Страница 80: ...Pump module applicable only for the Mini MIRI Humidity model The pump is used to transport the mixed gas through the chambers In time the perfor mance of this pump can be affected causing a longer re...

Страница 81: ...e gas lines must be replaced once every 3 years to maintain the fast recovery time after lid opening Please follow these safety precautions when changing gas lines Always use original gas lines contac...

Страница 82: ...lways use original pressure regulators contact Esco Medical or your local dis tributor for more details or ordering Change the regulators within 4 years from the date of installation Failure to change...

Страница 83: ...acement instructions 37 17 Firmware update If Esco Medical has released a newer version of the firmware this should be installed on the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators du...

Страница 84: ...with shippers about local customs regulations and delays that could arise from that The clinic must be informed about the site requirements before installation and should have signed the customer requ...

Страница 85: ...stallation procedure at the site 1 Follow the guidelines in the safety instructions and warnings section 2 Safety warning section 2 Connect the power cable to the UPS 3 Connect the power cable to the...

Страница 86: ...tion and re connection Use the User manual section as much as possible to get the User well ac quainted with it The user owner is informed that the first VOC filter change is 3 months after installati...

Страница 87: ...criteria or it in any way suffer from a severe error and incubation parameters are compromised the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator must be taken out of service until it is...

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