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Summary of Contents for Esco Medical Mini MIRI Dry / Humidity
- Page 1 CE 0088 ® Mini MIRI Dry / Humidity Multiroom incubators Rev. 1.0 Date revised 01.11.2021 Rx only...
- Page 2 Esco Medical Technologies, Ltd. Draugystės street 19 • Kaunas, Lithuania Tel +370 37 470 000 medical.escoglobal.com •support-medical@escoglobal.com 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 •...
- Page 3 During the war- ranty period, Esco Medical will, at our option, either repair or replace a product that proves to be defective at no charge, provided you return the product (shipping, duty, Mini MIRI Dry/Humidity incubators User Manual Rev.
- Page 4 This warranty is limited to repairing the instrument per Esco Medical's specifications. When you return an instrument to Esco Medical for service, repair or calibration, we rec- ommend shipment using the original shipping foam and container. If the original packing materials are not available, we recommend the following guide for repackaging •...
- Page 5 In an event where the seal must be broken to gain internal access to the instrument, you must first contact Esco Medical Ltd. 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.
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Page 6: Table Of Contents
Table of contents 1 How to use this manual ..........................9 2 Safety warning ............................. 9 3 Indication for use............................9 4 About the product ............................ 10 5 Accessories supplied ..........................12 6 Safety symbols and labels ........................12 7 Important safety instructions and warnings ................. 14 7.1 Before installation ........................... - Page 7 14.2 Gas level alarms ..........................32 14.2.1 CO alarms ..........................32 14.2.2 O alarms ..........................32 14.3 Gas pressure alarms ........................33 14.3.1 CO pressure alarm ......................33 14.3.2 N pressure alarm ......................... 33 14.4 Multiple alarms ..........................34 14.5 Alarm UV-C light (the functionality is not available in the US) ........34 14.6 Loss of power alarm ........................
- Page 8 28 Emergency Procedures........................47 29 User Troubleshooting .......................... 49 30 Specifications............................51 31 Electromagnetic compatibility ......................52 Mini MIRI Dry/Humidity incubators User Manual Rev. 1.0 ®...
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Page 9: How To Use This Manual
• If the equipment is used in a manner not specified by this manual, the protection provided by this equipment may be impaired. 3 Indication for use The Esco Medical Mini MIRI incubators are intended to be used to provide a stable cul- ®... -
Page 10: About The Product
The compartment's temperature will remain stable up to 1 °C (even when a lid is open for the 30s) and recover within 1 min after it is closed. The Esco Medical Mini MIRI incubators have 2 completely separate culture heat cham- ®... - Page 11 Refer to section “15.4 The culture mode” form more detailed information. The incubator can be connected to a PC running the Esco Medical data logging software for long term data logging and data storage.
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Page 12: Accessories Supplied
Humidity incubator) ® • 2 HEPA filter for input gas supply • 2 warming blocks • 1 USB stick containing Esco Medical Data logger software and PDF versions of the manuals • 1 medical grade power cord • 4 warranty labels •... - Page 13 1. Model. 2. Mains power rating. 3. CE mark. 4. Not protected against the ingress of water. 5. Manufacturer’s address and country of origin. 6. Consult instruction for use. 7. Observe WEEE. 8. Upper limit of temperature. 9. Keep away from direct sunlight. 10.
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Page 14: Important Safety Instructions And Warnings
Figure 6.1 Compartment numbers 7 Important safety instructions and warnings 7.1 Before installation 1. Do not use the product if the package is damaged. Contact Esco Medical or the local representative. 2. Read the user manual thoroughly before use. 3. Always keep these instructions easily accessible near the device. -
Page 15: Post-Installation
0.4 – 0.6 bar (5.80 – 8.70 PSI). 11. Never use any other except Esco Medical filter. Otherwise, the warranty will be void. 12. Do not use the device without a proper Esco Medical VOC/HEPA filter attached. -
Page 16: Mains Connection
10. Complete user training and finish reading instructions. 11. After a burn-in phase of 24-hours, the unit is ready for use IF the testing is suc- cessful. If the device is going to be used in a clinical setting, clean and disinfect the de- vice before use. - Page 17 inlet should be connected to a 100% concentration CO . CO control in the compartment is available in the range from 1.9% to 9.9%. The N inlet should be connected to 100% concentration N if low oxygen conditions are required. The O control in the compartments is available in the range from 3.9% - 19.9% by infusing N The premixed gas inlet should be connected to the CO...
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Page 18: Hepa/Voc Filter (Not Available In The Mini Miri ® Humidity)
11 HEPA/VOC filter (not available in the Mini MIRI Humidity) ® VOCs are hydrocarbon-based compounds that are found in fuel, solvents, adhesives, and other compounds. Examples of VOCs include isopropanol, benzene, hexane, formalde- hyde, vinyl chloride. VOCs can also occur in medical gases, such as CO and N . -
Page 19: User Interface
Figure 11.1 The flow arrow on the incubator Figure 11.2 The way of pulling the filter Figure 11.3 Filter in place Then, simultaneously press 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 is fitted incorrectly will cause the unit not to work not as intended. -
Page 20: Activating The Heat And Gas Controls
Table 12.1 The main keys and their purpose Description Image Rotary button Use to toggle and select items on the menu to change their status. It is also used to change the temperature and gas set points values ON/OFF button It is located in the REAR of the unit Alarm key It mutes an audible alarm and visually indicates the... -
Page 21: Status
12.3 Status Alternating between the 4 values under normal running conditions: Force scroll between parameters with rotating rotatory button (↻) or (↺). If the 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: 12.4 Main menu Press the rotatory button –... -
Page 22: Temperature Sub-Menu
Rotate the rotatory button (↻) to scroll further down in the menu. You can press the rotatory button to enter the CO sub-menu. Rotate the rotatory button (↻) to scroll further down in the menu. You can press the rotatory button to enter the O sub-menu. -
Page 23: Co Sub-Menu
Example - how to calibrate the temperature: The temperature has to be measured with a suitable and calibrated device. With a quality thermometer, it has been estimated that T1 is 37.4 °C. Locate “T1 CAL” in the sub-menu and press the rotatory button. The display should show: Rotate the rotatory button (↻) until the temperature measured by the thermometer is displayed on the panel. - Page 24 Move to the next CO sub-menu item with (↻) rotation or one step up with (↺) rotation. flow rate is shown (it cannot be adjusted): It shows the amount of CO gas put into the system while regulating. The volume is shown in liters/hour.
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Page 25: Sub-Menu
Calibration values should only be changed based on measurements taken by a trained user or technician. 12.4.3 O sub-menu Press the rotatory button on the O menu to enter the O sub-menu. Calibrate O by pressing the rotatory button and rotating it (↻) or (↺) to adjust. Move to the next O sub-menu item with (↻) rotation or one step up with (↺) rotation. -
Page 26: Uv-C Light Sub-Menu (The Functionality Is Not Available In The Us)
The value is in bar and it must be 0.4 – 0.6 bar (5.80 – 8.70 PSI) at all times. Example - How to calibrate O gas concentration has to be measured with a suitable and calibrated device. The real concertation has been estimated to be 5.3% on one of the gas sample ports. -
Page 27: Service Sub-Menu
Press the rotatory button on the service menu to enter the service sub-menu. The display will show the 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. -
Page 28: Installation With Premixed Gas
Then exit the menu by (↺) or press the rotatory button and hold it until the main menu does not appear. 13 Installation with premixed gas Mini MIRI Dry and Mini MIRI Humidity incubators have primarily been designed to run ®... - Page 29 Please read the “10 Gas connection” section in this manual above for more de- tailed gas connection requirements. Measure the gas concentration from the premixed gas bottle with a calibrated gas ana- lyzer. The result of the measurement is significant for the set-up of the device and the correct operation.
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Page 30: User Training
The CO setpoint must be 0.1% lower than the premixed gas measured value (i.e., 4.9% if 5.0% measured). The O setpoint must be 0.1 higher than the premixed gas measured value gas (i.e., 5.1% if 5.0% measured). For changing the CO and O setpoints, please read the 15.2 and 15.3 sections in this man- ual. -
Page 31: Alarms
14 Alarms The display will show a red “A” and the affected parameter's status message on a single fault condition. An audio signal can be muted by pressing the alarm key once (toggled on/off for 5-minutes). There will be a red arrow that indicates if the alarm is triggered due to too high or too low values, and the audio on/off key will blink red: Figure 14.1 Alarm key which indicates the alarm condition The audio pattern is 3 short beeps followed by a 3-second pause. -
Page 32: Gas Level Alarms
It denotes that the sensor in compartment 2 has failed. As a safety precaution, the heating of the affected area will be switched off. 14.2 Gas level alarms 14.2.1 CO alarms The CO gas level alarm is activated if the concentration of the CO gas deviates more than ±1% from the setpoint. -
Page 33: Gas Pressure Alarms
gas % is too low: 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 display will shift to normal status and show the parameters for 5 minutes until the audio alarm comes back on again. -
Page 34: Multiple Alarms
the alarm. “P” stands for pressure. 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 display will shift to normal status and show the parameters for 5 minutes until the audio alarm comes back on again. The mute alarm key will still show the alarm condition by blinking red while the alarm is muted. -
Page 35: Changing The Set Points
Figure 14.2 Alarm key which indicates the alarm condition 15 Changing the set points 15.1 The temperature setpoint The temperature setpoint can be adjusted in the range between 24.9 °C to 40.0 °C. The default temperature set point is 37.0 °C. To change the temperature setpoint, follow these instructions: 1. -
Page 36: O 2 Gas Concentration Set Point
3. After changing the value, press the rotatory key once more to save the value. If the display does not show the current temperature reading, rotatory button rotation (↻) or (↺) will toggle between the temperature, CO and mode readings. 15.3 O gas concentration set point The O... -
Page 37: Surface Temperatures And Measuring Temperature
0.8 mL (in 4 well dish). If the media stays longer without oil coverage, a high risk of media osmolality changes appear. If you have any questions or uncertainty, consult Esco Medical or your local representa- tive before using open culture mode in the Mini MIRI Multiroom incubator. - Page 38 Each area can be calibrated separately, using the item corresponding to the respective area in the menu. These items are placed in the menu and they are named: T1 CAL, T2 CAL, T3 CAL and T4 CAL. 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...
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Page 39: Pressure
placed in a dish with media and a mineral oil 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 suitably calibrated sensor to the middle of the lid area and close the lid. -
Page 40: Firmware
1. In the menu, locate the Service sub-menu “SERV” and rotate the rotatory button (↻). The display will show the 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. -
Page 41: Cleaning Instructions
20 Cleaning instructions 20.1 Considerations about a sterile device Mini MIRI Dry and Mini MIRI Humidity incubators are not sterile devices. They are not ® ® delivered sterile state and it is not possible to keep them sterile while in use. However, their design was created with great care to make it easy for the user to keep the device sufficiently clean during use and not contaminate the key components. -
Page 42: Manufacturer Recommended Disinfection Procedure
If the device is not visually clean, repeat the process from step 1. 20.3 Manufacturer recommended disinfection procedure Disinfection of the device (with no embryos inside) The use of gloves and good handling techniques are essential for successful disinfection. Proceed with the following steps (this procedure has been demonstrated during the on- site training program as part of the installation protocol): 1. -
Page 43: Humidification
Figure 21.1 Heat optimization plate Never incubate without the plates in place and never use non-Esco Medical heating optimization plates. It may cause dangerous and unpredictable tempera- ture conditions that may be harmful to the specimens. 22 Humidification 22.1 The Mini MIRI Humidity incubator ®... -
Page 44: Temperature Validation
If you have any questions, please consult Esco Medical or your local representative before you do open culture in the Mini MIRI Dry incubator. ® Open culture mode is designed not for embryo culturing but (if there is a need) for media equilibration. -
Page 45: Alarm Switch For An External System
Each sample port is directly connected to the corresponding compartment with the same number. The gas sample will be taken ONLY from the specific compartment. An external automatic gas sampler can be connected to the ports for continu- ous validation. Before any gas measurement, make sure that the lids had not been opened for at least 5 minutes. -
Page 46: Writing Area On The Compartment Lids
3.5mm jack connector Figure 25.1 No alarm mode Whenever the Mini MIRI incubator goes into an alarm mode, the switch will become an ® “open circuit”. It means that no current can run through the system anymore. 3.5mm jack connector Figure 25.2 “Open circuit”... -
Page 47: Maintenance
27 Maintenance Mini MIRI Dry and Mini MIRI Humidity incubators are designed to be user-friendly. ® ® Reliable and safe operation of this equipment is based on the following conditions: 1. Correct calibration of temperature and gas level, using high-precision equipment in the intervals prescribed based on clinical practice at the laboratory, where the Mini MIRI Dry or Mini MIRI... - Page 48 If a single temperature alarm goes off: • Remove the samples from the affected compartment. They can be relocated to any of the other compartments, which happens to be unoccupied. All compartments are separate so that the remaining ones will function normally. If multiple temperature alarms go off: •...
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Page 49: User Troubleshooting
29 User Troubleshooting Table 29.1 Heating system Symptom Cause Action The unit is switched off at the back Switch the device on or connect No heating, the display is off or not connected to the power the power The temperature is more than 0.5 °C off the set temperature The setpoint for temperature is No heating... - Page 50 Please refer to the software installa- not correctly installed tion guide Table 29.5 Display Symptom Cause Action Contact your Esco Medical Distribu- Missing segment(s) in display Failure in the PCB tor to replace the PCB Table 29.6 Keyboard Symptom Cause...
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Page 51: Specifications
30 Specifications Table 30.1 Mini MIRI Dry and Mini MIRI Humidity incubators specification ® ® Technical specifications Mini MIRI Dry or Mini MIRI Humidity incubator ® ® Overall dimensions (WxDxH) 525 x 420 x 230 mm Net weight 22 kg Shipping weight 32 kg Shipping dimensions (WxDxH) -
Page 52: Electromagnetic Compatibility
31 Electromagnetic compatibility Table 31.1 Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions Mini MIRI Dry and Mini MIRI Humidity incubators are intended for use in the electromagnetic environ- ® ® ment specified below. The customer or the user of Mini MIRI Dry or Mini MIRI Humidity incubators should ®... - Page 53 Guidance and manufacturer’s declaration – electromagnetic immunity Mini MIRI Dry and Mini MIRI Humidity incubators are intended for use in the electromagnetic environ- ® ® ment specified below. The customer or the user of Mini MIRI Dry or Mini MIRI Humidity incubators should ®...
- Page 54 Table 31.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and Mini MIRI Dry or Mini MIRI Humidity incubators ® ® Mini MIRI Dry or Mini MIRI Humidity incubators are intended to be used in an electromagnetic environ- ®...
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