Esco Medical CE 0123 User Manual
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Esco Medical CE 0123 User Manual

Miri and miri humidity multiroom ivf incubators
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CE 0123
USER MANUAL
MIRI
and MIRI
Humidity multiroom IVF
®
®
incubators
Rev. 6.1
Date of Revised 06.10.2022
Rx only

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  • Page 1 CE 0123 USER MANUAL MIRI and MIRI Humidity multiroom IVF ® ® incubators Rev. 6.1 Date of Revised 06.10.2022 Rx only...
  • Page 2 Esco Medical Technologies, UAB Draugystes g. 19 • Kaunas, Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com For Technical Service, contact Europe Esco Medical Technologies, UAB Draugystes g. 19 • Kaunas, Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com North America Esco Technologies, Inc.
  • Page 3 (2) years from the original purchase date, provided the instrument is calibrated and maintained following this manual. During the warranty period, Esco Medical will, at our option, either repair or replace a product MIRI and MIRI Humidity multiroom IVF 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 recommend 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 14 Installation with premixed gas ......................33 14.1 Installation procedure at the site .................... 34 14.2 User training ............................ 36 15 Alarms ................................ 36 15.1 Temperature alarms ........................37 15.2 Gas level alarms ..........................38 15.2.1 CO alarms ..........................38 15.2.2 O alarms ..........................
  • Page 8 24 Humidification ............................54 24.1 MIRI multiroom IVF incubator ....................54 ® 24.2 MIRI Humidity multiroom IVF incubator ................54 ® 25 Temperature validation ........................55 26 Gas level validation ..........................55 27 Alarm switch for an external system ..................... 56 28 Writing area on the compartment lids ..................
  • Page 9 36.9 Temperature check: Compartment lids ................75 36.10 6-hour stability test ........................75 36.11 Cleaning ............................76 36.12 Test documentation form ......................77 36.13 Recommended additional testing ..................77 36.13.1 A VOC meter (applicable only for the MIRI model) ..........77 ®...
  • Page 10 39.1 Responsibilities ..........................89 39.2 Before installation ......................... 90 39.3 Preparing for installation ......................90 39.4 Bring the following to the installation site ................90 39.5 Installation procedure at the site .................... 91 39.6 User training ............................ 91 39.7 After the installation ........................92 MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev.

  • 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

    3 Indication for use The Esco Medical MIRI family’s multiroom IVF incubators are intended to be used to ® provide a stable culture environment at or near body temperature and CO premixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF) / assisted reproduction technology (ART) treatments.
  • Page 13 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 14: Transport, Storage And Disposal

    one place to another. The device is manufactured under a full EU certified 13485 ISO quality management system. 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

    • 4 warranty labels • 1 pump box calibration tool (only for MIRI Humidity model) ® • 1 USB stick containing Esco Medical Data logger software and PDF version of the user manual MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 6.1 ®...

  • Page 16: Safety Symbols And Labels

    • 1 medical grade power cord • 1 3.5 mm external alarm jack connector • 1 set of fast male connectors with 15 silicone pipes Accessories do not apply with the MIRI and MIRI Humidity multiroom IVF incubators. ® ® 7 Safety symbols and labels There are several user labels on the surface of MIRI and MIRI...
  • Page 17 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 instruction for use. 7. Temperature limit. 8. Rx only. 9.
  • Page 18 Description Image Compartments numbers are indicated in the top corner of the lid with a label Maximum pressure 0.8 bar VOC/HEPA filter (only for MIRI model) ® pH Safe sense Gas sample ports PT 1000 validation sensors The connected external device to signal input/output connections should be compliant with the appropriate safety standard for medical equipment EN 60601-1.

  • Page 19: Important Safety Instructions And Warnings

    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 20: Getting Started

    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 MIRI Humidity multiroom IVF incubator).

  • Page 21: Mains Connection

    10 Mains connection The MIRI and MIRI Humidity multiroom IVF incubators come with a detachable mains ® ® power cord. The power cord is prepared for the country in which the unit is intended to be used. The ON/OFF switch provides the user with a means to isolate the MIRI and MIRI ®...
  • Page 22 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 5.0% - 20.0% by infusing N The premixed gas inlet should be connected to the CO inlet.

  • Page 23: Hepa / Voc Filter (Applicable Only For The Miri ® Model)

    12 HEPA / VOC filter (applicable only for the MIRI model) ® VOCs are hydrocarbon-based compounds that are found in fuel, solvents, adhesives and other compounds. Examples of VOCs include isopropanol, benzene, hexane, formaldehyde, vinyl chloride. VOCs can also occur in medical gases, such as CO and N .
  • Page 24 Figure 12.1 The flow arrow on the MIRI multiroom IVF incubator ® Figure 12.2 The way of pulling filter Figure 12.3 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 has been fitted incorrectly will cause the unit to work not as intended.

  • Page 25: User Interface

    13 User interface In the following chapters, the functions associated with keys and menu items are going to be explained. User interface handles daily used functions and more advanced adjustments that might be made to the device. The main keys and their purpose are presented in table 13.1. Table 13.1 Main keys and their purpose Description Image...

  • Page 26: 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 following 4 parameters: Temperature = Temperature in °C = CO concentration in % concentration in %...

  • Page 27: 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 (⇨) key to enter the menu. The user can exit the menu by pressing the (⇧) key. Temperature is the first category when the user enters the menu.

  • Page 28: Temperature Sub-Menu

    Press the (⇩) key to scroll to the last category on the menu. Press the (⇨) key 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 29: Co Sub-Menu

    13.4.2 CO sub-menu Press the (⇨) key on the CO menu to enter the CO sub-menu. The first item in the O sub-menu is O sensor calibration: Calibrate CO by holding down the SP key and using (⇧) and (⇩) keys to adjust. Move to the next CO sub-menu item with (⇩) key or one step up with (⇧) key.

  • Page 30: 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 concertation 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 31 Toggle O regulation on/off by holding the SP key and pressing (⇧) or (⇩) keys. The Default status for the O control is OFF. Move to the next O sub-menu item with (⇩) key or one step up with (⇧) key. flow rate is shown (it cannot be adjusted): It shows the amount of N gas put into the system while regulating.

  • Page 32: Uvc Light Sub-Menu (Applicable Only For The Miri ® Model)

    Adjust the calibration to the desired level by pressing (⇧) or (⇩) keys. In this case, we want to adjust to 5.3%. Press (⇧) key 3 times. The display will show 5.0, 5.1, 5.2 and 5.3. When O equals measured O , let go of the SP key.

  • Page 33: Installation With Premixed Gas

    And 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. Move to the next service sub-menu item with (⇩) key or one step up with (⇧) key.

  • Page 34: Installation Procedure At The Site

    Be advised that premixed gas consumption will be significantly higher compared to pure gas. Recover to the setpoint will be longer. 14.1 Installation procedure at the site Follow all the instructions in the installation manual and the guidelines in the user manual's safety instructions and warnings section.
  • Page 35 The user can exit the menu by pressing the (⇧) key. Press the (⇨) key to enter the Service sub-menu. The display will show the currently installed firmware version. Move to the next service sub-menu item with (⇩) key or one step up with (⇧) key. The display will show the "GAS"...

  • Page 36: User Training

    bottle. If this is not the case, it must be established if the bottle's concentration per the certificate is correct. If so, the MIRI and MIRI Humidity multiroom IVF ® ® incubators sensors must be calibrated. Refer to the user manual sections for gas calibration.

  • Page 37: Temperature Alarms

    15.1 Temperature alarms All 6 compartments can trigger a temperature alarm if their temperature varies over ±0.5 °C from the setpoint. Remember that changing the setpoint more than ±0.5 °C from the current temperature will result in an alarm. The same goes for all calibration adjustments. The number will indicate the zone triggering the alarm following "A".

  • Page 38: Gas Level Alarms

    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 ± 1% from the setpoint. Remember that changing the setpoint more than ± 1% from the current gas level will result in a gas level alarm.

  • Page 39: Gas Pressure Alarms

    % is too high: The display will lock on the alarm condition and will stop alternating between the standard 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: Pressure Alarm

    15.3.2 N pressure alarm If the N gas supply is not attached correctly or incorrect N gas pressure is applied to the system, MIRI and MIRI Humidity multiroom IVF incubators will go into N pressure ® ® alarm mode. The display will show "N2 P", which indicates an incorrect incoming gas pressure.

  • Page 41: Loss Of Power Alarm

    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 MIRI...

  • Page 42: Alarm Verification

    How it is Alarm Alarm Alarm name Conditions determined group priority When the O concentration drops by High Low O level 1% from the SP, after 5 min the alarm Technical priority will turn on alarm sensor reading When the O concentration rises by High High O...

  • Page 43: The Co Gas Concentration Set Point

    The default temperature setpoint is 37.0 °C. To change the temperature setpoint, follow these instructions: 1. When the display shows the current temperature: 2. Hold down the SP key and use (⇧) and (⇩) keys to adjust the setpoint: one keypress corresponds to a 0.1 change.

  • Page 44: The Culture Mode

    The default O setpoint is 5.0%. To change the O concentration setpoint, follow these instructions: 1. When the display shows the O concentration: 2. Hold down the SP key and use (⇧) and (⇩) keys to adjust the setpoint: one keypress corresponds to a 0.1 change.

  • Page 45: 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 representative before using open culture mode in the MIRI...
  • Page 46 CAL, T3 CAL, T4 CAL, T5 CAL, T6 CAL, T7 CAL, T8 CAL, T9 CAL, T10 CAL, T11 CAL and T12 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 Compartment 1...

  • Page 47: 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 48: 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 MIRI and MIRI Humidity 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 49 The MIRI or MIRI Humidity multiroom IVF incubators are equipped with a high-grade ® ® pH measuring system. A standard male BNC connector is located in the back of the unit. It can be connected to most standard pH combination probes. Probes that require a separate reference cannot be used.
  • Page 50 The recommended method to use the system is to fill a 4-well dish with 3 types of buffers in 3 of the wells (one type in each) and fill the 4 well with the culture media. Place the 4-well dish in one empty compartment and leave it to equilibrate. Before measuring in the culture media, calibrate the probe in the 3 buffers.

  • Page 51: Safe Sense Function

    Set the buffer levels with the (+) and (-) keys to correspond to the buffers used. Before measuring in the culture media, calibrate the probe in 2 or 3 buffers. It is necessary to rinse the probe between each insertion. After the calibration is performed and saved, quick pH measurement can be done in the culture media.

  • Page 52: Manufacturer Recommended Cleaning Procedure

    • A HEPA/VOC filter, which continually cleans the air inside the system (do not apply for the MIRI Humidity multiroom IVF incubator) ® • A removable heat optimization plate can be removed and cleaned (cannot be autoclaved!). As this serves as the main holding area for samples, this should be the highest priority to keep clean •...

  • Page 53: Heat Optimization Plates

    Use only the correct type of heat optimization plates for your dishes. Figure 23.1 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 temperature conditions that may be harmful to the specimens.

  • Page 54: Humidification

    1.0 °C above the temperature setpoint (thus making the lid 1.2 – 1.3 °C warmer than the insert surface). Please consult Esco Medical or your local representative before using "Open culture" mode in the MIRI multiroom IVF incubator if you have any questions.

  • Page 55: Temperature Validation

    The compartment's temperature conditions can be continuously logged through the external 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 56: Alarm Switch For An External System

    Figure 26.1 Gas sample ports Each sample port is directly connected to the corresponding compartment with the same number. The gas sample will be taken ONLY from the specific compartment. An external automatic gas sampler can be connected to the ports for continual validation.
  • Page 57 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 the "ON" position, as is illustrated below. Figure 27.1 No alarm mode Whenever the MIRI or MIRI Humidity multiroom IVF incubator goes into an alarm...

  • Page 58: Writing Area On The Compartment Lids

    28 Writing area on the compartment lids Each compartment lid on the MIRI or MIRI Humidity multiroom IVF incubator is made ® ® from white glass, optimized for writing text. The compartment's patient data or content can be noted down for easy reference during the incubation process. The text can be wiped off with a cloth afterward.

  • Page 59: Emergency Procedures

    Warranty is considered void if service and maintenance procedures are done not by trained and authorized personnel. 30 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.
  • Page 60 If the O 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 "O pressure alarm" section. In case of a gas pressure alarm on the unit: Inspect the external gas supply and the gas supply lines.

  • Page 61: User Troubleshooting

    31 User Troubleshooting Table 31.1 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 62 Table 31.3 O gas regulator Symptom Cause Action System not powered Check mains The system is on standby or Switch the system on switched off Activate the O gas regulator by gas regulator is off setting "O " to "ON" in the menu No O gas regulation Check gas supply, make sure that...

  • Page 63: Specifications

    32 Specifications Table 32.1 The MIRI multiroom IVF incubator specifications ® Technical specifications MIRI ® Overall dimensions (W×D×H) 700 x 585 x 165 mm Weight 40 kg Material Mild steel / Aluminum / PET / Stainless steel Power supply 115V 60Hz or 230V 50Hz Power consumption 300 W Temperature control range...

  • Page 64: Electromagnetic Compatibility

    33 Electromagnetic compatibility Table 33.1 Electromagnetic emissions Guidance and manufacturer's declaration – electromagnetic emissions The MIRI and MIRI Humidity multiroom IVF incubators are intended for use in the electromagnetic ® ® environment specified below. The customer or the user of the MIRI and MIRI Humidity multiroom IVF ®...
  • Page 65 IEC 61000-4-8 location in a commercial or hospital environment. Guidance and manufacturer's declaration – electromagnetic immunity The MIRI and MIRI Humidity multiroom IVF incubators are intended for use in the electromagnetic ® ® environment specified below. The customer or the user of the MIRI and MIRI Humidity multiroom IVF ®...
  • Page 66 Table 33.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and MIRI or MIRI Humidity multiroom IVF incubators ® ® The MIRI and MIRI Humidity multiroom IVF incubators are intended to be used in an electromagnetic ®...

  • Page 67: The Validation Guide

    34 The Validation guide 34.1 Product release criteria The Esco Medical MIRI and MIRI Humidity multiroom IVF incubators undergoes strict ® ® quality and performance testing before being released for sale. 34.1.1 Performance Each component used in the MIRI and MIRI Humidity multiroom IVF incubator is ®...

  • Page 68: 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. 35.1 Mandatory equipment All equipment must be of high quality and calibrated.

  • Page 69: Recommended Additional Equipment

    • A thermometer with a suitable sensor for measuring on an aluminum surface with a resolution minimum of 0.1 °C • A CO analyzer with a range of 0.0 – 10.0%. • An O analyzer with a range of 0.0 – 20.0%. •...

  • Page 70: About Co

    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. 36.1.1 About CO Carbon dioxide (CO ) is a colorless, odorless, non-combustible gas. Carbon dioxide above the triple point temperature of -56.6 °C and below the critical point temperature of 31.1 °C can exist in both a gaseous and a liquid state.

  • Page 71: Gas Supply N

    36.2 Gas supply N For the regulation to maintain the correct O concentration levels in the MIRI or MIRI ® ® Humidity multiroom IVF incubator compartments, the device must be connected to a stable source of 100% N at 0.4 – 0.6 bar (5.80 – 8.70 PSI) of pressure. Measure the N concentration in the gas supply by routing the gas line into a bottle without a lid and a suitably large opening.

  • Page 72: Co Gas Pressure Check

    • Oxygen (O ) 0.5 ppm. • Water (H 0) 0.5 ppm. 36.3 CO gas pressure check The MIRI and MIRI Humidity multiroom IVF incubators require a pressure of 0.4 – 0.6 ® ® bar (5.80 – 8.70 PSI) on the input CO gas line.

  • Page 73: Co Gas Concentration Check

    PASS: 230V ± 10.0% 115V ± 10.0% 36.6 CO gas concentration check The CO gas concentration is checked for deviation. The gas sample port on the side of the unit is used. Use sample port-6 for validation. Remember not to open any lid at least 15 min before starting the test nor during the testing itself.

  • Page 74: Temperature Check: Compartment Bottoms

    PASS: O concentration measured must not deviate more than ± 0.2% from the setpoint. 36.8 Temperature check: Compartment bottoms The first part of the temperature check is performed using a thermometer with a sensor suitable for measuring temperature in a droplet of media covered with Paraffin oil, with a resolution of 0.1 °C as a minimum.

  • Page 75: Temperature Check: Compartment Lids

    36.9 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. Tape the sensor to the center of the lid and carefully close the lid. Ensure that the tape keeps the sensor in complete contact with the surface area of the aluminum.

  • Page 76: Cleaning

    Make sure that the Esco Medical data logger software is running. Check that parameters are logged and give a meaningful reading. Let the device run without interfering for at least 6 hours. Analyze the results on the graphs. Pass I: Internal sensor temperature variation from set point is within ± 0.1 °C absolute.

  • Page 77: Test Documentation Form

    36.12 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. 36.13 Recommended additional testing 36.13.1 A VOC meter (applicable only for the MIRI model) ®...

  • Page 78: Temperature Check

    Table 37.1 Validation intervals Task Every day Every week Temperature check gas concentration check gas concentration check Check log for anomalies gas pressure check gas pressure check pH check 37.1 Temperature check The temperature check is performed using a high-precision thermometer. Place the thermometer on each zone and verify the temperature.

  • Page 79: Gas Concentration Check

    Humidity multiroom IVF incubators will not be affected, as 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. 37.4 CO gas pressure check...

  • Page 80: Gas Pressure Check

    However, continual validation of the performance is necessary. User validation should be done as a minimum according to instructions given in the "34 The Validation guide" section. If problems are encountered, contact Esco Medical or your local representative. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev.
  • Page 81 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 38.1. These components must be replaced in the time intervals specified below. Failure to follow these instructions may, in the worst-case scenario, result in damage to the specimens in the MIRI or MIRI...

  • Page 82: Voc/Hepa Filter Capsule (Applicable Only For The Miri ® Model)

    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 83: In-Line Hepa Filter For N Gas

    N 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 84: Co Sensor

    This sensor's lifetime is more than 6 years, but for safety reasons, Esco Medical recommends the sensor to be replaced once every 4-years. Please follow these safety precautions when changing the sensor: •...

  • Page 85: Cooling Fan

    It may cause the electronics to drift, resulting in low temperature and gas regulation. To avoid this, Esco Medical recommends that the cooling fan be replaced once every 3 years. Please follow these safety precautions when changing the cooling fan: •...

  • Page 86: Pump Module (Applicable Only For The Miri ® Humidity 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 87: Gas Lines

    This sensor's lifetime is more than 3 years, but Esco Medical recommends the sensor to be replaced once every 2 years for safety reasons. Please follow these safety precautions when changing sensors: •...

  • Page 88: 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 89: Firmware Update

    • Warranty void if wrong/ non-original filter is used. Please refer to the service manual for replacement instructions. 38.17 Firmware update If Esco Medical has released a newer version of the firmware, this should be installed on the MIRI and MIRI Humidity multiroom IVF incubators during the yearly scheduled ®...

  • Page 90: Before Installation

    39.2 Before installation 2 – 3 weeks before the installation due, the user/owner at the clinic is contacted via e- mail to plan the exact time to perform the installation. When a convenient time has been determined, travel and accommodation arrangements can be made. The released MIRI or MIRI Humidity multiroom IVF incubator must be sent 1 –...

  • Page 91: Installation Procedure At The Site

    • Memory stick with the latest released firmware & software. • High precision thermometer with a resolution not less than 0.1 °C. • Calibrated gas analyzer with precision at least 0.1% for CO and O and the possibility of returning gas samples to the MIRI or MIRI Humidity multiroom ®...

  • Page 92: 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.

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