Esco Medical Mini MIRI Dry Multiroom User Manual
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Esco Medical Mini MIRI Dry Multiroom User Manual

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CE 0088
®
Mini MIRI
Dry Multiroom incubator
Rev. 2.1
Date of revised 05.02.2020
Rx only

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Summary of Contents for Esco Medical Mini MIRI Dry Multiroom

  • Page 1 CE 0088 ® Mini MIRI Dry Multiroom incubator Rev. 2.1 Date of revised 05.02.2020 Rx only...
  • Page 2 For Technical Service, contact North America Esco Technologies, Inc. 903 Sheehy Drive, Suite F, Horsham, PA 19044, USA Tel 215-441-9661 • Fax 484-698-7757 www.escolifesciences.us • eti.admin@escoglobal.com Rest of the World Esco Micro Pte. Ltd. 21 Changi South Street 1 • Singapore 486 777 Tel +65 6542 0833 •...
  • Page 3 Return Procedure Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from Esco Medical Customer Service. All items being returned must be sent prepaid (freight, duty, brokerage and taxes) to our factory location.
  • Page 4 Warranty and Product Support Esco Medical warrants this instrument to be free from defects in materials and work- manship under normal use, and service for two (2) years from the date of original pur- chase, provided the instrument is calibrated and maintained in accordance with this manual.
  • Page 5 Esco Medical will not be responsible for lost shipments or instruments received in dam- aged condition due to improper packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and taxes). No returns will be accepted without a Return Materials Authorization ("RMA”) number.

  • Page 6: Table Of Contents

    Table of contents 1 How to use this manual ..........................8 2 Safety warning ............................. 8 3 Indication for use............................8 4 About the product ............................9 5 Accessories supplied ..........................9 6 Manuals supplied............................10 6.1 The User Manual ..........................10 6.2 The Validation Manual ........................
  • Page 7 14.2 Gas level alarms ..........................29 14.2.1 CO alarms ..........................29 14.2.2 O alarms ..........................30 14.3 Gas pressure alarms ........................30 14.3.1 CO pressure alarm ......................30 14.3.2 N pressure alarm ......................... 31 14.4 Multiple alarms ..........................31 14.5 Alarm UVC light (the functionality is not available in the US) ........311 14.6 Loss of power alarm ........................

  • Page 8: How To Use This Manual

    • If the equipment is used in a manner not specified by this manual, the protection provid- ed by this equipment may be impaired. 3 Indication for use The Esco Medical Mini MIRI dry incubator is intended to be used to provide a controlled en- ®...

  • Page 9: About The Product

    Open culture may lead to evaporation and a change in pH. If the correct condi- tions are not maintained. The incubator can be connected to a PC running the Esco Medical data logging software for long term data logging and data storage.

  • Page 10: Manuals Supplied

    • 2 HEPA filters for input gas supply • 2 warming blocks • 1 USB stick containing Esco Medical Data logger software and PDF versions of the manu- • 1 data cable • 1 power cord • 4 warranty labels •...

  • Page 11: Safety Symbols And Labels

    7 Safety symbols and labels There are several user labels on the surfaces of the Mini MIRI dry to guide the user. User ® labels are shown below. Mini MIRI Dry User Manual Rev. 2.1 ®...
  • Page 12 Table 7.1 Labels Description Image Packing box label: 1. If stored longer than the shelf life, the unit must be returned to the manufacturer for a new release test. 2. Shipping temperature between -20 C and 3. Keep away from direct sunlight. 4.

  • Page 13: Important Safety Instructions And Warnings

    Figure 7.1 Compartment numbers 8 Important safety instructions and warnings 8.1 Before installation 1. Do not use the product if the package is damaged. Contact Esco Medical or the local rep- resentative 2. Read the user manual completely before use 3.

  • Page 14: During Installation

    9. NEVER block gas supply holes in the compartment 10. Make sure that CO and N gas supply pressures are kept stable at 0.6 bar (8.70 psi) 11. Never use a non-Esco Medical filter; it will void the warranty Mini MIRI Dry User Manual Rev. 2.1 ®...

  • Page 15: Getting Started

    12. Do not use the product without a proper Esco Medical VOC/HEPA filter attached 9 Getting started The Mini MIRI dry must be installed by authorized and trained personnel on- ® 1. Follow the guidelines in the safety instructions and warnings section 2.

  • Page 16: Gas Connections

    Figure 10.1 Power supply 11 Gas connections On the back of the unit there are two gas inlets. These ports are marked “CO ” and “N ”. Figure 11.1 Gas inlet The CO inlet should be connected to 100% concentration CO The N inlet should be connected to 100% concentration N if low oxygen conditions are...

  • Page 17: Hepa / Voc Filter

    If premixed gas is used, request a copy of the premixed gas manual from Esco Medical or the local representative. 12 HEPA / VOC filter Volatile Organic Compounds (VOCs) are hydrocarbon-based compounds that are found in fuel, solvents, adhesives, and other compounds.

  • Page 18: Installation Of New Filter Capsule

    VOC levels in the 0.5 ppm range will typically allow for acceptable blastocyst development and reasonable pregnancy rates but will result in a high percentage of miscarriages. A combined HEPA and VOC filter (carbon filter) is integrated in the construction of the Mini MIRI dry.

  • Page 19: User Interfaces

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

  • Page 20: Activating The Heat And Gas Controls

    Table 13.1 Main keys and their purpose Description Image Rotatory button Use to toggle between the list of menu and to set their values On/off In the REAR of the unit Alarm key – Is used to mute an audible alarm and indicates the alarm condition visually by a flashing red circle of light.

  • Page 21: System Menu

    Force scroll between parameters with rotating rotatory button clockwise or anticlockwise. If O regulator is deactivated the system will display ‘O2 OFF’. If the use mode is Open Culture (no oil or paraffin overlay culture) the device shall be set for that and will display: 13.3 System menu Press and hold rotatory button for 3 seconds to access menu ...

  • Page 22: Temperature Sub-Menu

    Temperature is the first category when you enter the menu You can press rotatory button to enter the Temperature sub-menu Rotate rotatory button clockwise to scroll further down in menu You can press rotatory button to enter the CO sub-menu Rotate rotatory button clockwise to scroll further down in menu You can press rotatory button to enter the O...

  • Page 23: Co Sub-Menu

    Example - How to calibrate the temperature: Note: (the procedure is same for T1 – T12) With a quality thermometer, it has been noted that T1 is 37.4 C. Locate T1 in the submenu: 1. Press rotatory button. This display will show: 2.
  • Page 24 Toggle CO regulation on/off by pressing rotatory button and clockwise or anticlockwise rotation Move to the next sub-menu item with clockwise rotation or one step up with anticlockwise rotation flow rate is shown, it cannot be adjusted. This is the amount of CO gas put into the system while regulating.

  • Page 25: O 2 Sub-Menu

    Calibration values should only be changed based on measurements taken by a trained user or technician. 1. Navigate through the menu and find: 2. Press rotatory button and the display will show: 3. Adjust the calibration to the desired level by clockwise or anticlockwise rotation. In this case, we want to adjust to 6.4%.
  • Page 26 Toggle O regulation on/off by pressing rotatory button ant clockwise or anticlockwise rotation The Default status for the O control is OFF. Rotate clockwise to move to the next item in the O sub menu: flow rate is shown. This is the amount of N gas put into the system while regulating.

  • Page 27: Uvc Light Sub-Menu (Not Available In The Us)

    trained user or technician. 1. Navigate through the menu and find: 2. Press rotatory button and the display will show: 3. Adjust the calibration to the desired level by clockwise or anticlockwise rotation. In this case, we want to adjust to 6.3%. Rotate clockwise till the display will show 6.0; 6.1;...

  • Page 28: Service Sub-Menu

    Press rotatory button on serv to enter the Service sub-menu Currently installed firmware version: Ver 2.0 is only shown as an example; consult Esco Medical or the local representative for the number of the latest version. Rotate anticlockwise to exit the menu.

  • Page 29: Gas Level Alarms

    Temperature is too high in compartment 2. The display will lock-on the alarm condition and will stop alternating between the normal status messages. If the mute key is pressed, the display will shift to normal status and show the parameters for 5 minutes, until the audio alarm comes back on again.

  • Page 30: O 2 Alarms

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

  • Page 31: N 2 Pressure Alarm

    minutes, until the audio alarm comes back on again. The alarm mute key will still show the alarm condition by blinking red while the alarm is muted. 14.3.2 N pressure alarm If the N gas supply is not attached correctly or an incorrect N gas pressure is applied to the system, the MIRI-MIRI will go into N...

  • Page 32: Loss Of Power Alarm

    User should consult the distributor for further guidance or service inspection. Only when the UVC light works again will the “S” disappear. 14.6 Loss of power alarm If the power is disconnected, the incubator will give an audio alarm for approximately 4 seconds, and the LED in the alarm mute key will flash.

  • Page 33: The O Concentration Set Point

    2. Press rotatory button and rotate clockwise or anticlockwise to adjust the set point. If the display does not show the current CO reading, rotatory button rotation clockwise or anticlockwise will toggle between the temperature, CO and O readings. 15.3 The O concentration set point The O concentration can be adjusted in the range between 4% to 19.9%.

  • Page 34: Surface Temperatures And Measuring Temperature

    300 mOsm/kg. Up to 24-hours culturing in 100 mL volumes can be done with near un- changed osmolality. If you have any questions or uncertainty, consult Esco Medical or your local representative before you do open culture in the Mini MIRI dry.

  • Page 35: Example: Calibration Of Compartment 1

    Each area can be calibrated independently, using the item that corresponds to the respec- tive area in the menu. These items are placed in the menu and they are named: T1, T2, T3 and T4. An overview of the areas associated with the sensor names is shown in the table below: Table 16.1 Areas associated with sensors Area Bottom...

  • Page 36: Pressure

    Adjust using high precision measurements taken with a suitable sensor placed in a dish with media and a mineral oil overlay. Place the dish on one of the designat- ed spots indicated on the heating insert. Using a suitable high-quality thermometer, the temperature on T1 has been measured as 37.4 1.

  • Page 37: Pressure Of N Gas

    The CO pressure is shown in bar. External pressure must be from 0.4 bar (5.80 psi) to 0.6 bar (8.70 psi) at all times. It cannot be adjusted on the incubator but is adjusted on the external gas regulator. Remember there is a pressure alarm on the pressure limits: If the pressure falls below 0.2 bar or rises above 0.8 bar (2.90 –...

  • Page 38: Cleaning Instructions

    2. Press rotatory button to enter the Service sub-menu: Currently installed firmware version: 3. Rotate rotatory button anticlockwise to exit into the menu. 20 Cleaning instructions 20.1 Considerations about a sterile device The Mini MIRI® Dry incubator is not a sterile device: It is not delivered sterile, and it is not assumed to be possible to keep it sterile when in use.

  • Page 39: Manufacturer Recommended Disinfection Procedure

    It is recommended that the unit is cleaned with aqueous 70% isopropyl alcohol: 1. Moisten a sterile wipe (Gamma Wipe 300) and clean all internal and external sur- ® faces of the device by rubbing the wipe on the surfaces 2.

  • Page 40: Temperature Validation

    300 mOsm/kg. Up to 24-hour culturing in 100 mL volumes can be done with a nearly unchanged osmolality. If you have any questions, please consult Esco Medical or your local representative before you do open culture in the Mini MIRI dry.

  • Page 41: Gas Level Validation

    23 Gas level validation The gas concentration in each compartment of the Mini MIRI® Dry incubator can be vali- dated by taking a gas sample from one of the two gas sample ports on the side of the unit, using a suitable gas analyzer. Figure 24.1 Gas sample ports Each sample port is directly connected to the corresponding compartment with the corre- sponding number.

  • Page 42: Writing Area On The Compartment Lids

    Note that if a current source is attached to the 3.5mm jack connector the maxi- mum 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 unit will be in ‘ON’...

  • Page 43: Maintenance

    The text can be wiped off with a cloth afterwards. Only write with a suitable non-toxic pen that allows the text to be erased afterwards, and will not harm the samples being incubat- Figure 25.1 Area for patient information 26 Maintenance The Mini MIRI®...

  • Page 44: Emergency Procedures

    27 Emergency Procedures Total loss of power to or on the unit:  Remove all the samples and place them in an alternative or backup device that is not affected by the problem.  In an ambient environment temperature of 20 C the Mini MIRI®...

  • Page 45: User Troubleshooting

     Inspect the external gas supply and the gas supply lines. If the condition is judged to be permanent, it may be advantageous to switch off the O regulation in the menu. In case of a CO pressure alarm on the unit: ...
  • Page 46 Check CO gas supply; make ‘CO2 P’ is shown on the No/wrong CO gas pressure to sure that pressure is kept sta- display. the system ble at 0.6 bar (8.70 psi) Table 28.3 O gas regulation Symptom Cause Action No O2 gas regulation System not powered Check mains System is on standby or switched...

  • Page 47: Specifications

    Table 28.5 Display Symptom Cause Action Contact your Esco Medical Missing segment(s) in display Failure in the PCB Distributor to replace the PCB Table 28.6 Keyboard Symptom Cause Action Absent or erratic function of Contact your Esco Medical Failure in the keys...

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