Related Manuals for Esco Medical Mini MIRI Dry
Summary of Contents for Esco Medical Mini MIRI Dry
- Page 1 0123 USER MANUAL Mini MIRI Dry and Mini MIRI Humidity ® ® multiroom IVF incubators Rev. 9.0 Revision Date 26/06/2024 Rx only...
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Page 2: Copyright Information
Esco Medical Technologies, UAB Gamybos g. 2 • Ramuciai, Kauno r., 54468 Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com For Technical Service, contact: Europe Esco Medical Technologies, UAB Gamybos g. 2 • Ramuciai, Kauno r., 54468 Lithuania Tel +370 37 470 000 www.esco-medical.com •... - Page 3 If the medical device is delivered in good physical condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact your local sales representative or Esco Medical Technologies, UAB immediately. Standard Terms and Conditions Refunds &...
- Page 4 Technologies, UAB ISO certification. Warranty and Product Support Esco Medical Technologies, UAB warrants this medical device to be free from defects in materials and workmanship under regular use and service for two (2) years from the original purchase date, provided the medical device is calibrated and maintained following this manual.
- Page 5 Warranty Disclaimer If your medical device is serviced and/or calibrated by someone other than Esco Medical Technologies, UAB and their representatives, please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality Seal is removed or broken without proper factory authorization.
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Page 6: Table Of Contents
Table of contents 1 How to use this manual .......................... 11 2 Safety warning ............................11 3 Intended purpose/use ..........................12 4 About the product ............................ 12 5 Transport, Storage and Disposal ......................14 5.1 Transportation requirements ..................... 14 5.2 Storage and operation environment requirements............15 5.2.1 Storage requirements ...................... - Page 7 14 Installation with premixed gas ......................35 14.1 Installation procedure at the site .................... 36 14.2 User training ............................ 38 15 Alarms ................................ 38 15.1 Temperature alarms ........................39 15.2 Gas concentration alarms ......................40 15.2.1 CO alarms ..........................40 15.2.2 O alarms ..........................
- Page 8 22.2 Mini MIRI Humidity multiroom IVF incubator..............55 ® 23 Temperature validation ........................56 24 Gas concentration validation ......................56 25 Alarm switch for an external system ..................... 57 26 Writing area on the chamber lids ....................59 27 Maintenance ............................59 28 Emergency procedures ........................
- Page 9 34.11 Cleaning ............................77 34.12 Test documentation form ......................77 34.13 Recommended additional testing ..................77 34.13.1 A VOC meter (applicable only for the Mini MIRI Dry model) ......77 ® 34.13.2 A laser particle counter ....................78 35 Clinical use ..............................78 35.1 Temperature check ........................
- Page 10 37.6 User training ............................ 91 37.7 After the installation ........................91 38 Other countries ............................92 38.1 Switzerland ............................92 39 Reporting on serious incidents ......................92 Mini MIRI Dry & Humidity multiroom IVF incubators User Manual Rev. 9.0 ®...
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Page 11: How To Use This Manual
1 How to use this manual The manual is designed to be read by sections and not ideally from cover to cover. It means that if the manual is read from start to finish, there will be some repetition and overlap. -
Page 12: Intended Purpose/Use
(IVF) / assisted reproduction technology (ART) treatments. 4 About the product The Esco Medical Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ®... - Page 13 A dual beam infrared CO sensor with extremely low drift rates controls the CO concentration. A chemical medical grade oxygen sensor controls the level of O Gas recovery time is less than 3 min. after opening the lid for up to 30 seconds. To validate gas concentration, the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator...
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Page 14: Transport, Storage And Disposal
Dry and Mini MIRI Humidity multiroom IVF incubator can be connected ® ® to a PC running the Esco Medical Data logger software for long term data logging and data storage. MIRI family`s multiroom IVF incubators are stationary devices. The term refers to ®... -
Page 15: Storage And Operation Environment Requirements
These labels should be glued on the box: • Label with the marked packing date. • Label with the product name and serial number. 5.2 Storage and operation environment requirements 5.2.1 Storage requirements The device may only be store under the following conditions: •... -
Page 16: Supplied Service Parts And Accessories
• 2 × external 0.22µm HEPA filters for input gas supply. • 2 × heating optimization plates. • 1 × USB stick containing Esco Medical Data logger software and a PDF version of the English version of the user manual and all available translations. -
Page 17: Safety Symbols And Labels
7 Safety symbols and labels There are several user labels on the surfaces of Mini MIRI Dry and Mini MIRI Humidity ® ® multiroom IVF incubators to guide the user. User labels are shown below. Table 7.1 Packing box and electrical safety labels Description Image Packing box label for the Mini MIRI... - Page 18 Table 7.2 Device labels Description Image 1. Model. 2. Main's power rating. 3. CE mark. 4. Not protected against ingress of water. 5. Manufacturer's address and country of origin. 6. View instructions for use. 7. Temperature limit. 8. Rx only. 9.
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Page 19: Important Safety Instructions And Warnings
IVF incubators 8 Important safety instructions and warnings 8.1 Before installation 1. Do not use the product if the package is damaged. Contact Esco Medical Technologies, UAB or the local Representative. 2. Read the user manual thoroughly before use. -
Page 20: Post-Installation
5. A grounding-type (earthing) plug with two blades and a third prong is provided for your safety. If the provided plug does not fit into your outlet, consult an electrician to replace the outlet. 6. Always connect the power cord to a properly grounded outlet and only use the cord that came with the device. -
Page 21: Getting Started
0.4 – 0.6 bar (5.80 – 8.70 PSI). 11. Never use any other filter except those provided by Esco Medical Technologies, UAB. Otherwise, the warranty will be void. 12. Do not use the device without a proper Esco Medical Technologies, UAB... -
Page 22: Gas Connections
Do not defy the safety purpose of the grounding-type plug! A grounding-type plug has two blades and a prong, which is provided for your safety. If the provided plug does not fit into your outlet, consult an electrician to replace the outlet. The power requirement is 230V 50Hz OR 115V 60Hz. -
Page 23: Voc/Hepa Filter (Applicable Only For The Mini Miri ® Dry Model)
Always use a high-quality pressure regulator that can be set with the required precision for both gases. Figure 11.2 Pressure regulator Connect the CO gas to the CO inlet with a suitable silicone tube. Ensure that the tube is fastened with a clip so that it does not accidentally loosen itself during sudden pressure fluctuation. -
Page 24: Installation Procedure Of A New Voc/Hepa Filter
Unexpected sources of VOCs are commonly found in IVF labs. These can include cleaning agents, perfumes, cabinetry, grease on the wheels of equipment and sources in HVAC equipment. VOCs are typically measured in parts per million (ppm.) They can also be reported in parts per billion (ppb.) For IVF, the recommended count is below 0.5 ppm;... -
Page 25: User Interface
Figure 12.1 The flow arrow on the Mini MIRI Dry multiroom IVF incubator ® Then, simultaneously press both angle fittings (using both hands) into the holes till they snap into place (see Figure 12.2). The last 4 mm step should feel stiff. Figure 12.2 VOC/HEPA filter insertion and removal procedure Figure 12.3 Correctly installed VOC/HEPA filter A VOC/HEPA filter that has been installed incorrectly may cause gas leakage... -
Page 26: Activating The Heat And Gas Controls
Table 13.1 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 setpoints values ON/OFF button It is located in the REAR of the device Alarm button It mutes an audible alarm and visually indicates the alarm condition by a flashing red backlight. -
Page 27: Status
Rotate the rotatory button (↺) to exit the menu entirely. 13.3 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”... -
Page 28: Temperature Sub-Menu
Rotate the rotatory button (↻) to scroll further down in the menu. Press the rotatory button to enter the CO sub-menu. Rotate the rotatory button (↻) to scroll further down in the menu. Press the rotatory button to enter the O sub-menu. -
Page 29: Co Sub-Menu
Rotate the rotary button (↻) or (↺) to move between the sub-menu items. You can also go back to the main menu by rotating it the rotary button (↺) when the menu shows "T1 CAL". Each chamber has two internal temperature sensors. One in the chamber’s lid and another in the chamber bottom. - Page 30 items. You can also go back to the main menu by rotating it the rotary button (↺) when the menu shows "CO2.CAL". Toggle CO regulation on/off by pressing the rotatory button and rotating it (↻) or (↺). The default status for the CO control is OFF.
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Page 31: O 2 Sub-Menu
Example – how to calibrate CO gas concertation must be measured with a suitable and calibrated device. The real concertation has been estimated to be 6.4% on one of the gas sample ports. Every port is suitable for this purpose. Locate “CO2 CAL”... - Page 32 also go back to the main menu by rotating it the rotary button (↺) when the menu shows "O2.CAL". Toggle O regulation on/off by pressing the rotatory button and rotating it (↻) or (↺). The default status for the O control is OFF.
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Page 33: Uvc Light Sub-Menu (Applicable Only For The Mini Miri ® Model)
Example – how to calibrate O gas concertation must be measured with a suitable and calibrated device. The real O concertation has been estimated to be 5.3% on one of the gas sample ports. Every port is suitable for this purpose. Locate “O2 CAL”... -
Page 34: Service Sub-Menu
The default status for the UV-C light is “ON”. The UV light will automatically switch off when the device is turned off. For optimal air cleaning, it is recommended to have the UV-C light set to “ON” when the device is used. Exit the menu by rotating the rotary button (↺) or by pressing and holding down the rotatory button until the main menu disappears. -
Page 35: Installation With Premixed Gas
The display will show the “GAS” function: Press the rotatory button to enter and rotate the rotary button (↻) or (↺) to choose “PREMIX” or “CO ” options. When the desired gas mode is shown, press the rotary button to store it in the system. When choosing the gas mode, screen will alternate between: When using the premixed gas mode, it is necessary to use a premixed gas with HIGHER gradation than the setpoint. -
Page 36: Installation Procedure At The Site
Be advised that premixed gas consumption will be significantly higher compared to pure gas. Recovery to the setpoint will be longer. 14.1 Installation procedure at the site Follow all the instructions in the installation manual, the guidelines of the User Manual's safety instructions and the warnings section. - Page 37 Rotate the rotary button (↻) until “SERV” is displayed. Press the rotatory button on the service menu to enter the service sub-menu (if the menu is unlocked. For more information refer to the "13.4.5 Service sub-menu" section of this User Manual).. The display will show the currently installed firmware version.
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Page 38: User Training
control TURNS OFF when premix mode is activated. For changing the CO and O setpoints, please read the "16.2 The CO gas concentration setpoint" and "16.3 The O gas concentration setpoint" sections in this User Manual. If the setpoints are not set up correctly, a continual gas flow may occur, which will lead to high gas consumption and incorrect recovery times. -
Page 39: Temperature Alarms
red “A” will be displayed on the LED matrix, followed by an alarm cause and an arrow pointing up or down (depending on the nature of the alarm condition) and the value of the alarm cause. For example: if temperature is too low in chamber 1, the display will show "A1... -
Page 40: Gas Concentration Alarms
the alarm menu again until the alarm button is pressed. The mute alarm button will still show the alarm condition by blinking red while the alarm is muted. Please refer to the "28 Emergency procedures" section of the User Manual on how to behave when there is a temperature alarm. -
Page 41: O 2 Alarms
status and show the parameters for 5 minutes until the audio alarm comes back on again. The mute alarm button will still show the alarm condition by blinking red while the alarm is muted. Please refer to the "28 Emergency procedures" section of the User Manual on how to behave when there is a CO concentration alarm. -
Page 42: N 2 Pressure Alarm
go into CO pressure alarm mode. The display will show "CO2 P", which indicates an incorrect 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"... -
Page 43: Multiple Alarms
The user should consult the distributor for further guidance or service inspection. Only when the UV-C light works again will the "S" disappear. Please contact your Esco Medical distributor for more details. 15.6 Loss of power alarm If the power is disconnected, the Mini MIRI... -
Page 44: Summary Of The Alarms
15.7 Summary of the alarms In the table below, there is a list of every possible alarm in the Mini MIRI Dry and Mini ® MIRI Humidity multiroom IVF incubators. ® Table 15.1 Every possible alarm in the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ®... -
Page 45: Alarm Verification
15.8 Alarm verification In the table below, there is a list of how and when to verify the functionality of the alarm system. Table 15.2 Every possible alarm in the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ®... -
Page 46: The Co Gas Concentration Set Point
16.2 The CO gas concentration set point The CO concentration can be adjusted in the range between 1.9% to 9.9%. The default CO setpoint is 6.0%. To change the CO gas concentration setpoint, follow these instructions: 1. When the display shows the CO gas concentration: 2. -
Page 47: The Culture Mode
16.4 The culture mode The culture mode can be set to "Oil culture" or "Open culture". "Oil culture" culture mode is used when the culture media has an oil or Paraffin overlay. "Open culture" mode is used when the culture media does not have any overlay. The default setting is “Oil culture”... -
Page 48: Surface Temperatures And Measuring Temperature
If you have any questions or if there is uncertainty about these settings, consult Esco Medical Technologies, UAB or your local representative before using open culture mode in the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator. ® ®... - Page 49 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 the calibration settings – make sure that only the altered value corresponds to where the measurement is done.
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Page 50: Pressure
The user may check the temperature inside the dish by placing the sensor inside the dish with media and mineral oil overlay. Calibration value change procedure should only be done with a calibrated device and by a trained user or the technician, according to specific measurements. 18 Pressure 18.1 CO gas pressure... -
Page 51: Firmware
The internal pressure sensor cannot be calibrated by the user. Under normal circumstances, the pressure sensor is replaced every 2 years according to the maintenance plan. 19 Firmware The firmware installed on your Mini MIRI Dry or Mini MIRI Humidity multiroom IVF ®... -
Page 52: Manufacturer's Recommended Cleaning Procedure
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. The design features intended to provide cleanliness include: • A circulated air system. •... -
Page 53: Manufacturer's Recommended Disinfection Procedure
20.3 Manufacturer’s recommended disinfection procedure Disinfection of the device (with no embryos inside) Wearing gloves and GLP (good laboratory practice) techniques are essential to the successful disinfection of the device. Proceed with the following steps (this procedure has been demonstrated during the on- site training program as part of the installation protocol): 1. -
Page 54: Heating Optimization Plates
"Plain" version of the heating optimization plate. Use only the correct type of heat plates for your dishes. Never incubate without the plates in place and never use non-Esco Medical Technologies, UAB approved heating optimization plates. It may cause dangerous and unpredictable temperature conditions that may be harmful to the specimens. -
Page 55: Mini Miri ® Humidity Multiroom Ivf Incubator
Mini MIRI Dry multiroom IVF incubator is not created to work with a water ® container inside. Otherwise, the device will be damaged. The safety and performance of the device will be affected. 22.2 Mini MIRI Humidity multiroom IVF incubator ®... -
Page 56: Temperature Validation
The chamber's temperature conditions can be continuously logged through the external connectors on the device's side without compromising its performance. Any logging system that uses standard PT-1000 sensors may be used. Esco Medical Technologies, UAB can supply an external logging system (MIRI – GA) for ®... -
Page 57: Alarm Switch For An External System
Figure 24.1 Gas sample ports Each sample port is directly connected to the corresponding chamber with the same number. The gas sample will be taken ONLY from the specific chamber. An external automatic gas sampler can be connected to the ports for continual validation. - Page 58 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 device will be in the "ON" position, as is illustrated below. Figure 25.1 No alarm mode Whenever the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator goes into...
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Page 59: Writing Area On The Chamber Lids
26 Writing area on the chamber lids Each chamber’s lid on the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF ® ® incubator is made from white glass, optimized for writing text. The chamber'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 afterward. -
Page 60: Emergency Procedures
Warranty void if service and maintenance procedures are not followed or if service and maintenance procedures are done not by trained and authorized personnel. 28 Emergency procedures Total loss of power to or on the device: • Remove all the samples and place them in an alternative or backup device that is not affected by the problem;... - Page 61 If the CO pressure alarm goes off: • Inspect the external gas supply and gas supply lines. If the problem is external and not readily fixed, follow the guidelines under the "15.3.1 CO pressure alarm" section of the User Manual. If the N pressure alarm goes off: •...
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Page 62: User Troubleshooting
29 User troubleshooting Table 29.1 Heating system Symptom Cause Action The device is switched off at the Switch the device on or connect No heating, the display is off back 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 63 0.4 – gas input 0.6 bar (5.80 – 8.70 PSI) Check O setpoint. If the issue The actual gas concentration is persists, contact Esco Medical higher than the setpoint support Lid(s) are left open Close lid(s) Poor O...
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Page 64: Specifications
30 Specifications Table 30.1 Mini MIRI Dry multiroom IVF incubator’s specifications ® Technical specifications Mini MIRI ® Overall dimensions (W×D×H) 525 x 420 x 230 mm Weight 22 kg Material Mild steel / Aluminum / PET / Stainless steel Power supply 115V 60Hz OR 230V 50Hz Power consumption 160 W... -
Page 65: Electromagnetic Compatibility
31 Electromagnetic compatibility Table 31.1 Electromagnetic emissions Guidance and manufacturer's declaration – electromagnetic emissions The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are intended for use in the ® ® electromagnetic environment specified below. The customer or the user of the Mini MIRI Dry and Mini ®... - Page 66 Power frequency The power-frequency magnetic (50/60 Hz) fields' level should Performance magnetic field 3 A/m characteristic specific location in a commercial or IEC 61000-4-8 hospital environment. Guidance and manufacturer's declaration – electromagnetic immunity The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are intended for use in the ®...
- Page 67 electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters). The Mini MIRI Dry and Mini MIRI Humidity multiroom ® ® IVF incubators are recommended below, according to the communications equipment's maximum output power. Separation distance according to the frequency of the transmitter (m) The rated maximum output power of the 150 kHz to 80...
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Page 68: Validation Guide
32 Validation guide 32.1 Product release criteria The Esco Medical Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ® ® undergo strict quality and performance testing before being released for sale. 32.1.1 Performance Each component used in the Mini MIRI... -
Page 69: Visual Inspection
In the following sections, we describe these tests and the equipment necessary to perform them. A test documentation form is also provided. A copy must be provided to Esco Medical Technologies, UAB for internal device tracking and device history record. -
Page 70: Mandatory Equipment
33.1 Mandatory equipment All equipment must be of high quality and calibrated. • A thermometer with a suitable sensor for measuring in a droplet of media covered with Paraffin oil with a minimum resolution of 0.1 °C. • A thermometer with a suitable sensor for measuring on an aluminum surface with a minimum resolution of 0.1 °C. -
Page 71: About Co
The sample should be taken from the bottle near the bottom with the gas analyzer. PASS: CO concentration measured must be between 98.0% - 100%. Use of CO gas with moisture will damage the flow sensors. Moisture level must be verified on the gas manufacturer's certificate: only 0.0 ppm v/v Max is permissible. -
Page 72: Gas Supply N
• Total Sulphur (as S) 0.1 ppm v/v max. 34.2 Gas supply N For the regulation to maintain the correct O concentration levels in the Mini MIRI ® or Mini MIRI Humidity multiroom IVF incubator chambers, the device must be ®... -
Page 73: Co Gas Pressure Check
• Methane 0.5 ppm; • Oxygen (O ) 0.5 ppm; • Water (H O) 0.5 ppm. 34.3 CO gas pressure check The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator requires a ® ® pressure of 0.4 – 0.6 bar (5.80 – 8.70 PSI) on the input CO gas line. -
Page 74: Co Gas Concentration Check
Measure the UPS's output plug that the Mini MIRI Dry or Mini MIRI Humidity ® ® multiroom IVF incubator will be connected. Also, check that the UPS is attached to a properly grounded mains outlet. Use a multimeter set for AC. PASS: 230V ±... -
Page 75: Temperature Check: Chamber Bottoms
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 chamber). Only measure while ® the value on the gas analyzer stabilizes. Please refer to the "13.4.3 O sub-menu"... -
Page 76: Temperature Check: Chamber Lids
PASS: all temperatures measured on the bottom of the chambers where the dishes are located must not deviate more than ± 0.1 °C from the setpoint. 34.9 Temperature check: chamber lids The second part of the temperature validation is performed using a thermometer with a suitable sensor for measuring temperature on an aluminum surface, with a resolution of 0.1 °C as a minimum. -
Page 77: Cleaning
If the N is not available, the test can be done without it. Make sure that the Esco Medical data logger software is running. Check that parameter are logged and give a meaningful reading. Let the device run without interfering for at least 6 hours. Analyze the results on the graphs. -
Page 78: A Laser Particle Counter
35 Clinical use Congratulations! Your device is now ready for clinical use with the validation tests completed and the test report submitted to Esco Medical Technologies, UAB. It is necessary to monitor the performance of the device continually. Use the below scheme for in-use validation. -
Page 79: Co Gas Concentration Check
PASS: • All temperatures measured on the bottom of the chamber in the locations where the dishes would be placed must not deviate more than ± 0.1 °C from the setpoint. • All temperatures measured on the lid must not deviate more than ± 0.5 °C from the setpoint. -
Page 80: Co Gas Pressure Check
Dry or Mini MIRI Humidity multiroom ® ® IVF incubator (loop sampling) avoids negative pressure and ensures accuracy. Contact Esco Medical Technologies, UAB or the local distributor for further guidance. 35.4 CO gas pressure check The Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator requires a pressure ®... -
Page 81: Maintenance Guide
User validation should be done as a minimum according to instructions given in the "32 Validation guide" section of the User Manual. If problems are encountered, contact Esco Medical Technologies, UAB or your local representative. However, to sustain the high-performance level and avoid system errors, the owner is responsible for having a certified technician who performs components replacements according to table 36.1. -
Page 82: Voc/Hepa Filter Capsule (Applicable Only For The Mini Miri ® Model)
Dry multiroom IVF incubator must be replaced every 3 months. ® Please follow these safety precautions when changing the VOC/HEPA filter: • Always use the original filter (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Change filter every 3 months. -
Page 83: Humidification Bottle (Applicable Only For The Mini Miri ® Humidity Model)
CO regulation system. Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Change the filter once every year. -
Page 84: Sensor
This sensor's lifetime is more than 6 years, but for safety reasons, Esco Medical Technologies recommends the sensor to be replaced once every 4-years. Please follow these safety precautions when changing the sensor: Mini MIRI Dry &... -
Page 85: Uv Light (Applicable Only For The Mini Miri ® Model)
Always power the device off before removing any cover. Please follow these safety precautions when changing the UV-C light: • Always use an original UV-C light bulb (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). -
Page 86: Internal Gas Pump (Applicable Only For The Mini Miri ® Model)
3 years. Please follow these safety precautions when changing the cooling fan: • Always use an original fan (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Change the fan within 3 years from the date of installation. -
Page 87: Proportional Valves
• Always use an original gas pump (contact Esco Medical Technologies, UAB 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 may cause slow recovery times or breakdowns. -
Page 88: Flow Sensors
• Warranty void if wrong/non-original regulators are used. Please refer to the service manual for replacement instructions. 36.15 Firmware update If Esco Medical Technologies, UAB has released a newer version of the firmware, it should be installed on the Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ®... -
Page 89: Installation Guide
All individuals who will perform installation, repair and/or maintenance of the device must be trained by Esco Medical Technologies, UAB or at a qualified training center. Experienced service technicians or embryologists conduct training to ensure that the installation personnel clearly understand the device's functions, performance, testing, and maintenance. -
Page 90: Preparing For Installation
3. The required space for placement is 1.0 m x 0.6 m. 4. Temperature control should be able to maintain a stable temperature, never exceeding 30 °C. 5. Humidity control to avoid condensation. 6. Uninterrupted power supply (UPS) with 115 or 230 V, minimum 120 W. 7. -
Page 91: After The Installation
When the installation trip is finished, a copy of the original "Installation report" form must be sent to Esco Medical Technologies, UAB. 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. -
Page 92: Other Countries
In case of any serious incidents that have occurred in relation to the device should be reported to Esco Medical Technologies, UAB by contacts, written on the contact information page, and the Authorised Representative in which the user and/or patient is established.
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