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

Multiroom ivf incubators
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CE 0088
USER MANUAL
Mini MIRI
Dry and Mini MIRI
Humidity
®
®
Multiroom IVF incubators
Rev. 3.0
Date revised 05.06.2021
Rx only

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  • Page 1 CE 0088 USER MANUAL Mini MIRI Dry and Mini MIRI Humidity ® ® Multiroom IVF incubators Rev. 3.0 Date revised 05.06.2021 Rx only...
  • Page 2 Esco Medical Technologies, Ltd. Draugyste s 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,...
  • 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.

  • Page 6: Table Of Contents

    Table of contents 1 How to use this manual .......................... 11 2 Safety warning ............................11 3 Indication for 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............14 5.2.1 Storage requirements ......................
  • Page 7 13.4.5 Service sub-menu ........................32 14 Installation with premixed gas ......................32 14.1 Installation procedure at the site .................... 33 14.2 User training ............................ 35 15 Alarms ................................ 35 15.1 Temperature alarms ........................36 15.2 Gas level alarms ..........................37 15.2.1 CO alarms ..........................
  • Page 8 23.2 Mini MIRI Humidity multiroom IVF incubator..............49 ® 24 Temperature validation ........................49 25 Gas level validation ..........................50 26 Alarm switch for an external system ..................... 50 27 Writing area on the compartment lids ..................52 28 Maintenance ............................52 29 Emergency Procedures........................
  • Page 9 35.11 Cleaning ............................70 35.12 Test documentation form ......................71 35.13 Recommended additional testing ..................71 35.13.1 A VOC meter (applicable only for the Mini MIRI Dry model) ......71 ® 35.13.2 A laser particle counter ....................71 36 Clinical use ..............................71 36.1 Temperature check ........................
  • Page 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 installation ........................86 Mini MIRI Dry and Mini MIRI Humidity Multiroom IVF incubators User Manual ®...

  • 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: Indication For 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 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. Mini MIRI Dry and Mini MIRI Humidity Multiroom IVF incubators User Manual ®...

  • Page 14: Transport, Storage And Disposal

    The device is manufactured under a full EU certified 13485 ISO quality management sys- tem. This product fulfils the requirements of EN60601-1 3rd edition standards as a Class I type B equivalent device suited for continuous operation. It also conforms to the requirements of the Regulation (EU) 2017/745 concerning medical devices and is classified as a Class IIa device under rule II.

  • Page 15: Operation Environment Requirements

    • 1 pump box calibration tool (only for Mini MIRI Humidity model) ® • 1 USB stick containing Esco Medical Data logger software and a PDF version of the user manual • 1 medical grade power cord • 1 3,5 mm external alarm jack connector •...

  • Page 16: Safety Symbols And Labels

    Accessories do not apply with the Mini MIRI Dry and Mini MIRI Humidity multiroom ® ® IVF incubators. 7 Safety symbols and labels There are several user labels on the surfaces of Mini MIRI Dry and Mini MIRI Humidity ® ®...
  • Page 17 Table 7.2 Device label 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 instruction for use. 7. Observe WEEE. 8. Upper limit of temperature. 9.

  • Page 18: 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 or the local representative. 2. Read the user manual thoroughly before use. 3. Always keep these instructions easily accessible near the device.

  • Page 19: 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 (do not apply for Mini MIRI Humidity multiroom IVF incubator).

  • Page 20: Mains Connection

    3. Connect the mains cable to the Mini MIRI Dry or Mini MIRI Humidity multiroom ® ® IVF incubator. 4. Connect gas lines. 5. Set the gas pressure on the external gas regulator at 0.4 – 0.6 bar (5.80 – 8.70 PSI). 6.

  • Page 21: Gas Connections

    11 Gas connections There are two gas inlets on the back of the unit. These ports are marked "CO 100% Inlet" and "N 100% Inlet". Figure 11.1 Gas inlets on the back of Mini MIRI Dry and ® MIRI Humidity multiroom IVF incubators ®...

  • Page 22: Hepa / Voc Filter (Applicable Only For The Mini Miri ® Dry Model)

    Connect the N inlet to the Nitrogen Bottle in a similar way. Figure 11.3 Gas filter Connect the N inlet to the Nitrogen Bottle in a similar way. The Mini MIRI and Mini MIRI Humidity multiroom IVF incubators can also ®...

  • Page 23: Installation Of New Filter Capsule

    A combined HEPA and VOC filter (carbon filter) are integrated into the construction of the Mini MIRI Dry multiroom IVF incubator. Before entering the Mini MIRI Dry multi- ® ® room IVF incubator, the gas is sent through the filter in a single pass. Then, upon return from the compartment, the gas is filtered again.

  • Page 24: User Interface

    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 has been fitted incorrectly will cause the unit to work not as intended.

  • Page 25: Activating The Heat And Gas Controls

    13.1 Activating the heat and gas controls Heat and gas controls are activated using the "ON/OFF" switch in the rear. Soon after system activation, the main display will alternate the reading between the fol- lowing 4 parameters: Temperature = Temperature in °C = CO concentration in % concentration in %...

  • Page 26: Main Menu

    If the use mode is “Open Culture” (no oil or Paraffin overlay culture), the device shall be set for that and will display: 13.4 Main menu Press the rotatory button – enter the menu. The user can exit the menu by rotating the rotatory button (↺). Temperature is the first category when the user enters the menu.

  • Page 27: Temperature Sub-Menu

    Rotate the rotatory button (↻) to scroll further down in the menu. Press the rotatory button to enter the Service sub-menu. 13.4.1 Temperature sub-menu Press the (⇨) key on the temperature menu to enter the temperature sub-menu. Calibrate holding down the SP key and using (⇧) and (⇩) keys to adjust. Move to the next sub-menu item with (⇩) key or one step up with (⇧) key.

  • Page 28: Co Sub-Menu

    13.4.2 CO sub-menu Press the rotatory button on the CO menu to enter the CO sub-menu. The first item in the CO sub-menu is CO sensor calibration: Calibrate CO by pressing the rotatory button and rotating it (↻) or (↺) to adjust. Move to the next CO sub-menu item with (↻) rotation or one step up with (↺) rotation.

  • Page 29: O 2 Sub-Menu

    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 CO gas concentration has to 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.
  • Page 30 Toggle O regulation on/off by pressing the rotatory button and rotating it (↻) or (↺). The Default status for the O control is OFF. Move to the next O sub-menu item with (↻) rotation or one step up with (↺) rotation. flow rate is shown (it cannot be adjusted): It shows the amount of N gas put into the system while regulating.

  • Page 31: Uvc Light Sub-Menu (Applicable Only For The Mini Miri ® Model)

    Rotate rotator button (↻) to adjust the O calibration to the desired level by (↻) or (↺) rotation. In this case, we want to change to 5.3%. Rotate (↻) till the display shows 5.0, 5.1, 5.2 and 5.3. When O equals measured O press the rotatory button.

  • Page 32: 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 33: Installation Procedure At The Site

    The Premixed gas concentration must be chosen specifically to match the re- quirement of the culture medium. As the Mini MIRI Dry and Mini MIRI Humidity ® ® multiroom IVF incubators cannot alter the concentration, the media's resulting pH will depend on the correct concentration choice. Be advised that premixed gas consumption will be significantly higher com- pared to pure gas.
  • Page 34 The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators must be set to ® ® premix gas work mode. Please follow these instructions: Press the rotatory button – enter the menu. The user can exit the menu by rotating the rotatory button (↺). Press the rotatory button on the service menu to enter the service sub-menu.

  • Page 35: User Training

    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. The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators con- ® ® tain a high-grade CO and O sensor.

  • Page 36: Temperature Alarms

    Figure 15.1 Alarm key which indicate the alarm condition The audio pattern is 3 short beeps followed by a 3-second pause. All alarms have the same audio pattern. 15.1 Temperature alarms All 2 compartments can trigger a temperature alarm if their temperature varies over ±0.5 °C from the setpoint.

  • Page 37: 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. 15.2 Gas level alarms 15.2.1 CO alarms The CO gas level alarm is activated if the concentration of the CO gas deviates more than ±...

  • Page 38: Gas Pressure Alarms

    % 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. The mute alarm key will still show the alarm condition by blinking red while the alarm is muted.

  • Page 39: Multiple Alarms

    "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 40: Changing The Set Points

    16 Changing the set points 16.1 The temperature set point The temperature setpoint can be adjusted in the range between 24.9 °C to 40.0 °C. The default temperature setpoint is 37.0 °C. To change the temperature setpoint, follow these instructions: 1.

  • Page 41: The O Gas Concentration Set Point

    16.3 The O gas concentration set point The O concentration can be adjusted in the range between 3.9% to 19.9%. The default O setpoint is 5.0% To change the O gas concentration setpoint, follow these instructions: 1. When the display shows the O gas concentration: 2.

  • Page 42: Surface Temperatures And Measuring Temperature

    0.8 mL (in 4 well dishes). If the media stays longer without oil coverage, a high risk of media osmolality changes appears. If you have any questions or uncertainty, consult Esco Medical or your local representa- tive before using open culture mode in the Mini MIRI...
  • Page 43 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 17.1 Areas associated with sensors Area Bottom...

  • Page 44: Pressure

    Adjust according to a high precision measurement done with a suitable sensor placed in a dish with media and a mineral oil overlay. Place the dish on one of the designated spots indicated on the heating insert. Procced to validate if the lid temperature is precisely 0.2 °C higher than the bottom temperature.

  • Page 45: Firmware

    The N pressure is shown in bar. External pressure must be between 0.4 – 0.6 bar (5.80 – 8.70 PSI) at all times. It cannot be adjusted on the Mini MIRI Dry and Mini MIRI Humid- ® ® ity multiroom IVF incubator; it must be done on the external gas regulator. Remember 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 –...

  • Page 46: Cleaning Instructions

    Please read more about SAFE Sense software in the SAFE Sense User manual. 21 Cleaning instructions 21.1 Considerations about a sterile device The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are not sterile ® ® devices. They are not delivered sterile state and it is not possible to keep them sterile when in use.

  • Page 47: Manufacturer Recommended Disinfection Procedure

    1. It is recommended to clean the unit with an aqueous 70% isopropyl alcohol. Mois- ten a sterile wipe and clean all the device's internal and external surfaces by rub- bing the surfaces' wipe. 2. After wiping, leave the device's lids open for some time to ensure that all alcohol fumes evaporate.

  • Page 48: Humidification

    Use only the correct type of heat optimization plates for your dishes. Figure 22.1 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.

  • Page 49: Mini Miri ® Humidity Multiroom Ivf Incubator

    Please consult Esco Medical or your local representative before using "Open culture" mode in the Mini MIRI Dry multiroom IVF incubator if you have any questions. ® "Open culture" mode is designed not for embryo culturing but (if there is a need) for media equilibration.

  • Page 50: Gas Level Validation

    The compartment's temperature conditions can be continuously logged through the ex- ternal connectors on the unit's side without compromising its performance. Any logging system that uses standard PT-1000 sensors may be used. Esco Medical can supply an external logging system (MIRI – GA12) for the sensors. ®...
  • Page 51 equipped with a 3.5 mm jack connector on the back that can be connected to a monitoring device. Whenever an alarm goes off (that could be temperature alarm, gas alarms for CO or O levels, low-pressure or high-pressure alarms for CO and N gases) or if the power supply to the unit suddenly cut, the switch is indicating that the unit needs to be inspected by the...

  • Page 52: Writing Area On The Compartment Lids

    Figure 26.2 "Open circuit" alarm mode Whenever the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incuba- ® ® tor's power cord is disconnected from the power source, this switch will automati- cally indicate an alarm! It is an extra safety feature intended to alert the personnel in case of a power cut in the laboratory.

  • Page 53: Emergency Procedures

    Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are used. The ® ® manufacturer recommends that the period between validation should be no longer than 14 days. 2. VOC/HEPA filters must be replaced every 3 months. 3. In-line HEPA filters must be replaced yearly during annual maintenance. 4.
  • Page 54 If multiple temperature alarms go off: • Remove the samples from the affected compartments. They can be relocated to any of the other compartments, which happens to be unoccupied. All compart- ments are separate so that the remaining ones will function normally. •...

  • Page 55: User Troubleshooting

    30 User Troubleshooting Table 30.1 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 56 Please refer to the software in- not correctly installed stallation guide Table 30.5 Display Symptom Cause Action Contact your Esco Medical Dis- Missing segment(s) in display Failure in the PCB tributor to replace the PCB Table 30.6 Keyboard Symptom Cause...

  • Page 57: Specifications

    31 Specifications Table 31.1 Mini MIRI Dry multiroom IVF incubator 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 90 W...

  • Page 58: Electromagnetic Compatibility

    32 Electromagnetic compatibility Table 32.1 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 elec- ® ® tromagnetic environment specified below. The customer or the user of the Mini MIRI Dry and Mini MIRI ®...
  • Page 59 Power frequency The power-frequency magnetic (50/60 Hz) fields' level should be charac- Performance magnetic field 3 A/m teristic of a specific location in a commercial or hospital envi- IEC 61000-4-8 ronment. Guidance and manufacturer's declaration – electromagnetic immunity The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are intended for use in the elec- ®...
  • Page 60 Table 32.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubators ® ® The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators are intended to be used in an ®...

  • Page 61: The Validation Guide

    33 The Validation guide 33.1 Product release criteria The Esco Medical Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubators ® ® undergoes strict quality and performance testing before being released for sale. 33.1.1 Performance Each component used in the Mini MIRI...

  • Page 62: Cosmetic

    In the following, 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 for internal device tracking and device history record. Mini MIRI...

  • Page 63: Mandatory Equipment

    34.1 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 resolution minimum of 0.1 °C • A thermometer with a suitable sensor for measuring on an aluminum surface with a resolution minimum of 0.1 °C •...

  • Page 64: About Co

    Sample 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 per- missible.

  • Page 65: Gas Supply N

    • Methanol 10 ppm v/v max. • Hydrogen Cyanide 0.5 ppm v/v max. • Total Sulphur (as S) 0.1 ppm v/v max. 35.2 Gas supply N For the regulation to maintain the correct O concentration levels in the Mini MIRI ®...

  • Page 66: Co Gas Pressure Check

    • Carbon Dioxide (CO ) 1.0 ppm. • Carbon Monoxide (CO) 1.0 ppm. • Hydrogen (H ) 0.5 ppm. • Methane 0.5 ppm. • Oxygen (O ) 0.5 ppm. • Water (H 0) 0.5 ppm. 35.3 CO gas pressure check The Mini MIRI Dry and Mini MIRI Humidity multiroom IVF incubator requires a pres-...

  • Page 67: Co Gas Concentration Check

    Measure the UPS's output plug that the Mini MIRI Dry or Mini MIRI Humidity multi- ® ® room 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 68: Temperature Check: Compartment 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 compartment). Only measure ® while the value on the gas analyzer stabilizes. Please refer to the "13.4.3 O sub-menu"...

  • Page 69: Temperature Check: Compartment Lids

    PASS: all temperatures measured on the bottom of the compartments where the dishes are located must not deviate more than ± 0.1 °C from the setpoint. 35.9 Temperature check: Compartment 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 70: 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 with- out interfering for at least 6 hours. Analyze the results on the graphs.

  • Page 71: Test Documentation Form

    20 minutes before inserting a sample. 35.12 Test documentation form The "Installation report" form must be completed with the tests-passed status filled by installation personnel and submitted to Esco Medical before the device is taken into clinical use. 35.13 Recommended additional testing 35.13.1 A VOC meter (applicable only for the Mini MIRI...

  • Page 72: Temperature Check

    Do not attempt to run the Mini MIRI Dry or Mini MIRI Humidity multiroom ® ® IVF incubator for clinical purposes without access to high-grade quality control val- idation equipment. Table 36.1 Validation intervals Task Every day Every week Temperature check gas concentration check gas concentration check Check log for anomalies...

  • Page 73: O 2 Gas Concentration Check

    Humidity multiroom IVF incubator will not be ® ® affected. The gas in the compartment is not under pressure, and the reading is just an artifact based on unsuitable measuring equipment. Contact Esco Medical or the local distributor for further guidance. 36.4 CO gas pressure check...

  • Page 74: N 2 Gas Pressure Check

    User validation should be done as a minimum according to instructions given in the "33 The Validation guide" section. If problems are encountered, contact Esco Medical 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 ac- cording to table 37.1.

  • Page 75: Voc/Hepa Filter Capsule (Applicable Only For The Mini Miri ® Model)

    These components must be replaced in the time intervals specified below. Failure to fol- low these instructions may, in the worst-case scenario, result in damage to the specimens in the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator. ®...

  • Page 76: Humidification Bottle (Applicable Only For The Mini Miri ® Humidity Model)

    IVF incubator must be replaced every 3 months. Please follow these safety precautions when changing the VOC filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change filter every 3 months.

  • Page 77: In-Line Hepa Filter For N

    Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year. • Failure to change the filter on time will result in low/no cleaning of incoming N gas.

  • Page 78: Co Sensor

    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 changing the sensor: •...

  • Page 79: Cooling Fan

    Always power 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 or your local distrib- utor for more details or ordering). • Change UV-C light bulb within 1 year from date of installation.

  • Page 80: Internal Gas Pump (Applicable Only For The Mini Miri ® Model)

    Please follow these safety precautions when changing the internal gas pump: • Always 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.

  • Page 81: Gas Lines

    The flow sensors are used by the CO regulations and for logging the unit's gas con- sumption. This sensor's lifetime is more than 3 years, but Esco Medical recommends the sensor be replaced once every 2 year for safety reasons.

  • Page 82: Pressure Regulators

    CO regulator system. Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 83: Internal 0.2Μ Filter For N

    • Warranty void if wrong/ non-original filter is used. Please refer to the service manual for replacement 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 during the yearly ®...

  • Page 84: Before Installation

    All individuals who will perform installation, repair and/or maintenance of the instru- ment must be trained by Esco Medical or at a qualified training center. Experienced ser- vice technicians or embryologists conduct training to ensure that the installation person- nel clearly understand the instrument's functions, performance, testing, and mainte- nance.

  • Page 85: Bring The Following To The Installation Site

    The service tool kit is checked for content before every installation trip to ensure • it contains the necessary tools. Always bring the latest versions of firmware and data logging software. Bring • these files on a labeled memory stick to the service site. 38.4 Bring the following to the installation site •...

  • Page 86: 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.
  • Page 87 If the Mini MIRI Dry or Mini MIRI Humidity multiroom IVF incubator fails ® ® any of the "Installation report" form acceptance criteria, or it in any way suffer from a severe error and incubation parameters are compromised, the Mini MIRI ®...

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