Related Manuals for Esco Medical MIRI
Summary of Contents for Esco Medical MIRI
- Page 1 0123 USER MANUAL MIRI and 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
13.4 Main menu ............................28 13.4.1 Temperature sub-menu ..................... 29 13.4.2 CO sub-menu ......................... 30 13.4.3 O sub-menu..........................32 13.4.4 UVC light sub-menu (applicable only for the MIRI model) ........ 34 ® 13.4.5 Service sub-menu ........................35 MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. - Page 7 ......................42 15.3.2 N pressure alarm ......................... 43 15.4 Multiple alarms ..........................43 15.5 Alarm UVC light (applicable only for the MIRI model) ..........44 ® 15.6 Loss of power alarm ........................44 15.7 Summary of the alarms ....................... 44 15.8 Alarm verification .........................
- Page 8 23.1 MIRI multiroom IVF incubator ....................58 ® 23.2 MIRI Humidity multiroom IVF incubator ................58 ® 24 Temperature validation ........................59 25 Gas concentration validation ......................59 26 Alarm switch for an external system ..................... 60 27 Writing area on the chamber lids ....................61 28 Maintenance ............................
- Page 9 35.10 6-hour stability test ........................78 35.11 Cleaning ............................79 35.12 Test documentation form ......................79 35.13 Recommended additional testing ..................79 35.13.1 A VOC meter (applicable only for the MIRI model) ..........79 ® 35.13.2 A laser particle counter ....................80 36 Clinical use ..............................
- Page 10 38.6 User training ............................ 93 38.7 After the installation ........................93 39 Other countries ............................94 39.1 Switzerland ............................94 40 Reporting on serious incidents ......................94 MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®...
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Page 11: How To Use This Manual
Digital version of the English user manual and all available translated versions are available on our website www.esco-medical.com. To locate this user manual, simply follow these steps: 1. Click on the "Products" tab in the navigation menu. 2. Scroll down and select "MIRI Multiroom Incubator or MIRI Humidity ®... -
Page 12: Intended Purpose/Use
MIRI Humidity multiroom IVF incubators have 6 ® ® completely separate culture heat chambers. Each chamber has its own heated lid and heating optimization plate for a Petri dish. MIRI and MIRI Humidity capacity for a 35 ® ®... - Page 13 VOC/HEPA filter. The UVC light has filters that inhibit any 185 nm radiation that would produce dangerous ozone. The VOC/HEPA filter is located under the UVC light. UVC light modules and VOC/HEPA filters are not applied in the MIRI Humidity ®...
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Page 14: Transport, Storage And Disposal
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
The device may have been used for treating and processing infectious substances. Therefore, the device and device components may be contaminated. Device must be disinfected or decontaminated prior to disposal. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 16: Supplied Service Parts And Accessories
• 2 × external 0.22µm HEPA filters for input gas supply. • 6 × heating optimization plates. • 1 × USB stick containing Esco Medical Data logger software and 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 surface of MIRI and MIRI Humidity multiroom IVF ® ® incubators to guide the user. User labels are shown below. Table 7.1 Packing box and electrical safety labels... - Page 18 10. UDI-DI code. 11. Logo. 12. Keep away from direct sunlight. 13. Observe WEEE. 14. Keep dry. 15. Date of manufacture. 16. Medical device. Table 7.3 Info labels on MIRI and MIRI Humidity multiroom IVF incubators ® ® Description Image...
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Page 19: Important Safety Instructions And Warnings
Humidity multiroom 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. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ®... -
Page 20: During Installation
2. Servicing is required according to the service manual as well as cases when the device has been damaged in any way, e. g. suppose the apparatus has been dropped, exposed to rain or moisture or does not operate normally. The MIRI ®... -
Page 21: Getting Started
5. Perform temperature and gas calibration at the intervals described in the manuals. 6. Never leave the lids open for more than 30 sec while in use. 7. The VOC/HEPA filter must be changed every 3 months (it does not apply for MIRI ® Humidity multiroom IVF incubator). -
Page 22: Mains Connection
® ® medical grade power cord. The power cord is prepared for the country in which the device is intended to be used. The ON/OFF switch provides the user with means to isolate the MIRI and MIRI ® ® Humidity multiroom IVF incubator from the main power source. -
Page 23: Gas Connections
11 Gas connections There are two gas inlets on the back of the device. These ports are marked "CO 100% Inlet" and "N 100% Inlet". Figure 11.1 Gas inlets on the back of MIRI ® MIRI Humidity multiroom IVF incubators ®... -
Page 24: Voc/Hepa Filter (Applicable Only For The Miri ® Model)
VOCs can also occur in medical gases, such as CO and N . It is essential to use in-line VOC filters to prevent these fumes from entering your MIRI family’s multiroom IVF ® incubators. 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. -
Page 25: Installation Procedure Of A New Voc/Hepa Filter
VOC levels in the 0.5 ppm range will typically allow an acceptable blastocyst development and reasonable pregnancy rates but will likely result in a high percentage of miscarriages. A combined VOC/HEPA filter is integrated into the construction of the MIRI multiroom ®... -
Page 26: User Interface
The VOC/HEPA filter is removed by gently pulling it straight out using both hands (see Figure 12.2). Never run the MIRI multiroom IVF incubator if the VOC/HEPA filter is ® missing! Gas leakage and dangerous particle contamination could occur! -
Page 27: Activating The Heat And Gas Controls
% concentration in % Mode = Open/Oil Culture 13.2 System menu Press and hold (⇧) and (⇩) keys together for 3 seconds to access the menu. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 28: Status
13.4 Main menu Press the (⇨) key to enter the menu. The user can exit the menu by pressing the (⇧) key. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 29: Temperature Sub-Menu
Press the (⇨) key to enter the O sub-menu. Press the (⇩) key to scroll further down in the menu. Press the (⇨) key to enter the UVC light sub-menu (not available in the MIRI Humidity ® multiroom IVF incubator). -
Page 30: 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 CO sub-menu is CO sensor calibration: MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... - Page 31 It will usually change depending on the current concentration of CO in the system. Press the (⇩) key to move to the next item in the CO sub-menu. Here you can see the CO internal pressure (it cannot be adjusted on the MIRI and MIRI Humidity multiroom IVF ® ®...
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Page 32: O 2 Sub-Menu
Use (⇩) or (⇧) keys to move between the sub-menu items. You can also go back to the main menu by pressing the (⇧) key when the menu shows "O2 CAL". MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ®... - Page 33 Press (⇩) key to move to the next item in the O sub-menu. Here you can see the O internal pressure (it cannot be adjusted on the MIRI and MIRI ® ® Humidity multiroom IVF incubator. It is adjusted on the external gas regulator): The value is in bar and it must be 0.4 –...
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Page 34: Uvc Light Sub-Menu (Applicable Only For The Miri ® Model)
Calibration value change procedure should only be done with a calibrated device and by a trained user or the technician, according to specific measurements. Exit the menu by pressing the (⇧) key. 13.4.4 UVC light sub-menu (applicable only for the MIRI model) ®... -
Page 35: Service Sub-Menu
SP key. Let go of the SP key when the desired gas mode is displayed. It will be now stored. When choosing the gas mode, screen will alternate between: MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 36: Installation With Premixed Gas
A premixed gas is usually used for simpler incubation systems that do not contain any CO and O sensors and have no gas mixing capabilities. This section describes how to install the MIRI or MIRI Humidity multiroom IVF ®... - Page 37 Measure the gas concentration from the premixed gas bottle with a calibrated gas analyzer. The result of the measurement is significant for the set-up of the device and the correct operation. regulation must be "ON" in the MIRI or MIRI Humidity multiroom IVF incubator ®...
- Page 38 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. The MIRI or MIRI Humidity multiroom IVF incubators contain high-grade ®...
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Page 39: User Training
100% CO and 100% N as the source gas. Only the setpoint for CO can be set – it is an inherent compromise of using premixed gas. The MIRI ® MIRI Humidity multiroom IVF incubators cannot change the gas composition of ®... -
Page 40: Temperature Alarms
The zone layout and sensor placement are described in the “17 Surface temperatures and measuring temperature" section of the User Manual. If a temperature sensor malfunctions, it will be indicated by the following warning: MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 41: Gas Concentration Alarms
Remember that changing the setpoint more than ±1% from the current gas concentration will result in a gas concentration alarm. The same goes for all calibration adjustments. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 42: Gas Pressure Alarms
15.3.1 CO pressure alarm If the CO gas supply is not attached correctly or incorrect CO gas pressure is applied to the system, the MIRI and MIRI Humidity multiroom IVF incubators will go into CO ® ® pressure alarm mode. The display will show "CO2 P", which indicates an incorrect incoming gas pressure. -
Page 43: N 2 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 44: Alarm Uvc Light (Applicable Only For The Miri ® Model)
Please refer to the "29 Emergency procedures" section of the User Manual on how to behave when there is a loss of power alarm. 15.7 Summary of the alarms In the table below, there is a list of every possible alarm in the MIRI and MIRI Humidity ®... -
Page 45: Alarm Verification
Technical alarm 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 Alarm verification in the MIRI and MIRI Humidity multiroom IVF incubators ® ®... -
Page 46: Changing The Setpoints
2. Hold down the SP key and use (⇧) and (⇩) keys to adjust the setpoint: one keypress corresponds to a 0.1 change. 3. After changing the CO gas concentration setpoint, let go of the SP key. The value is now stored. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 47: The O Gas Concentration Setpoint
2. Hold down the SP key and use (⇧) and (⇩) keys to change the mode. 3. When the display shows the desired/correct mode, let go of the SP key. The culture mode is now saved. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 48: Surface Temperatures And Measuring Temperature
MIRI and MIRI Humidity multiroom IVF incubator. ® ® 17 Surface temperatures and measuring temperature In this section, the MIRI or MIRI Humidity multiroom IVF incubators temperature ® ® controls system is described in more detail. The MIRI... - Page 49 Figure 17.1 Temperature zones in MIRI and MIRI Humidity multiroom IVF incubators ® ® Each area can be calibrated separately, using the item corresponding to the respective area in the menu. These items are placed in the Temperature sub-menu and are named: T1 CAL, T2 CAL, T3 CAL, T4 CAL, T5 CAL, T6 CAL, T7 CAL, T8 CAL, T9 CAL, T10 CAL, T11 CAL and T12 CAL.
- Page 50 This statement only applies when the „Oil culture“ mode is used. In "Open culture" mode, the lid temperature will be increased by 1.0 °C above the temperature setpoint. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ®...
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Page 51: Pressure
CO sub-menu: The CO 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 ®... -
Page 52: Firmware
MIRI Humidity multiroom IVF incubators is ® ® upgradeable. Whenever a critical update is available, it will be provided to our distributors around the world – they will make sure that your MIRI and MIRI Humidity ® ® multiroom IVF incubator runs with the newest available firmware. A service technician can do this during the scheduled annual service. - Page 53 4-well dish in one empty chamber and leave it to equilibrate. Before measuring in the culture media, calibrate the probe in the 3 buffers. Rinse the probe between each insertion. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®...
- Page 54 Press the "Calibrate" key: Figure 20.4 4-well dish with 3 buffers and media Set the buffer levels with the (+) and (-) keys to correspond to the buffers used. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®...
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Page 55: Cleaning Instructions
• A circulated air system. • External 0.22µm and internal 0.2µm HEPA filters which clean the incoming gas. • A VOC/HEPA filter, which continuously cleans the air inside the system (does not apply for the MIRI Humidity multiroom IVF incubator). ®... -
Page 56: Manufacturer's Recommended Disinfection Procedure
The combination of standard cleaning procedures and disinfection procedures using alcohol-free detergents is recommended for event-related concerns such as media spills, visual accumulation of soil and/or other evidence of contamination. It is also recommended to clean and disinfect the MIRI and MIRI Humidity multiroom ®... -
Page 57: Heating Optimization Plates
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 58: Humidification
23 Humidification 23.1 MIRI multiroom IVF incubator ® The MIRI multiroom IVF incubator must not be irrigated. Humidification of the MIRI ® ® multiroom IVF incubator will damage the device – condensation will block internal pipes and damage electronic parts. -
Page 59: 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) to ®... -
Page 60: Alarm Switch For An External System
Taking out a large sample volume may affect the gas concentration in the system. Make sure that the gas analyzer is calibrated before use. 26 Alarm switch for an external system The MIRI and MIRI Humidity multiroom IVF incubator can be connected to an external ®... -
Page 61: Writing Area On The Chamber Lids
It is an extra safety feature intended to alert the personnel in case of a power cut in the laboratory. 27 Writing area on the chamber lids Each chamber's lid on the MIRI or MIRI Humidity multiroom IVF incubator is made ®... -
Page 62: Maintenance
2. VOC/HEPA filters must be replaced every 3 months. 3. External and internal HEPA filters must be replaced yearly during annual maintenance. 4. According to the clinical practice intervals, suitable cleaning procedures must be employed in the laboratory where the MIRI and MIRI Humidity multiroom IVF ®... -
Page 63: 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. • Without the power source, the internal temperature of the MIRI and MIRI ®... -
Page 64: User Troubleshooting
System not powered Switch the system on No O gas regulation Activate the O gas regulator by gas regulator is off setting "O " to "ON" in the menu MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... - Page 65 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 66: Specifications
31 Specifications Table 31.1 MIRI multiroom IVF incubator’s specifications ® Technical specifications MIRI ® Overall dimensions (W×D×H) 700 × 585 × 165 mm Weight 40 kg Material Mild steel / Aluminum / PET / Stainless steel Power supply 115V 60Hz or 230V 50Hz... -
Page 67: Electromagnetic Compatibility
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 ® ® incubator should ensure that it is used in such an environment. - Page 68 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 ® ® incubator should ensure that it is used in such an environment.
- Page 69 MIRI Humidity multiroom IVF incubators are intended to be used in an electromagnetic ® ® environment in which radiated RF disturbances are controlled. The customer, or the MIRI and MIRI ® ® Humidity multiroom IVF incubator user, can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters).
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Page 70: Validation Guide
EN60601-1 3 edition standards are met. 33.1.3 Communication & data logging Each device is connected to a computer running the MIRI multiroom IVF incubator data ® logging software. The data received by the PC program is analyzed to ensure... -
Page 71: 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 72: Mandatory Equipment
All equipment must be of high quality and calibrated. • A VOC meter able to measure the most common volatile organic compounds at least at the ppm-level. • With the laser particle counter, a sample should be taken just above the MIRI ® MIRI Humidity multiroom IVF incubator. -
Page 73: About Co
• Acetaldehyde 0.2 ppm v/v max. • Benzene 0.02 ppm v/v max. • Carbon Monoxide 10 ppm v/v max. • Methanol 10 ppm v/v max. • Hydrogen Cyanide 0.5 ppm v/v max. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 74: Gas Supply N
35.2 Gas supply N In order for the regulation system to maintain the correct O concentration levels in the MIRI or MIRI Humidity multiroom IVF incubator chambers, the device must be ® ® connected to a stable supply of 100% N at 0.4 –... -
Page 75: Co Gas Pressure Check
) 0.5 ppm. • Water (H 0) 0.5 ppm. 35.3 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 76: Voltage Supply
Connect the gas analyzer inlet tube to the sample port. Make sure that the fit is perfect and that no air can enter or exit the system. The gas analyzer must have a gas return port connected to the MIRI or MIRI Humidity ®... -
Page 77: Temperature Check: Chamber Bottoms
Hook-up the gas analyzer inlet tube to the sample port. Make sure that the fit is perfect and that no air can enter or exit the system. The gas analyzer must have a gas return port connected to the MIRI or MIRI Humidity ®... -
Page 78: Temperature Check: Chamber Lids
If the preference of CO setpoint is 6.0% or temperature is different from the default setting, an adjustment needs to be done before the test. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 79: Cleaning
35.13 Recommended additional testing 35.13.1 A VOC meter (applicable only for the MIRI model) ® With the VOC meter, a sample should be taken just above the MIRI and MIRI Humidity ® ® multiroom IVF incubator. The reading should be noted down as the background VOC level. -
Page 80: A Laser Particle Counter
36 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 continuously. Use the below scheme for in-use validation. -
Page 81: Co Gas Concentration Check
Please refer to the "13.4.3 O sub-menu" section of the User Manual for more information on how to perform the O gas calibration. MIRI and MIRI Humidity multiroom IVF incubators User Manual Rev. 9.0 ® ®... -
Page 82: Co Gas Pressure Check
Gas analyzers use a small pump to draw out gas from the location being sampled. The pump capacity varies from brand to brand. The gas analyzer's ability to return the gas sample to the MIRI or MIRI Humidity multiroom IVF incubator ®... -
Page 83: Ph Check
User validation should be done periodically according to instructions given in the "33 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 Tables 37.1 and 37.2. -
Page 84: Voc/Hepa Filter Capsule (Applicable Only For The Miri ® Model)
× Pressure regulators × A firmware update (if a new version has been × released) 37.1 VOC/HEPA filter capsule (applicable only for the MIRI model) ® The VOC/HEPA filter capsule is placed on the MIRI multiroom IVF incubator device's ®... -
Page 85: Humidification Bottle (Applicable Only For The Miri ® Humidity Model)
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 86: O 2 Sensor
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 (every two years in MIRI Humidity multiroom ®... -
Page 87: Co Sensor
CO gas is too low. This sensor's lifetime is more than 6 years, but for safety reasons, Esco Medical Technologies, UAB recommends the sensor to be replaced once every 4-years. Please follow these safety precautions when changing the sensor: •... -
Page 88: Cooling Fan
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 89: 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 Technologies, UAB or your local distributor for more details or ordering). • Change the gas pump within 2 years from the date of installation. -
Page 90: Flow Sensors
Please follow these safety precautions when changing gas lines: • Always use original gas lines (contact Esco Medical Technologies, UAB or your local distributor for more details or ordering). • Failure to change the gas lines may cause slow recovery times or breakdowns. -
Page 91: Firmware Update
Please refer to the service manual for replacement instructions. 37.15 Firmware update If Esco Medical Technologies, UAB has released a newer version of the firmware, it should be installed on the MIRI and MIRI Humidity multiroom IVF incubators during the ®... -
Page 92: Preparing For Installation
38.3 Preparing for installation Bring the "Installation report" from. Make sure it is the latest and current version • only. Fill out the following blank boxes in the form: the MIRI or MIRI Humidity ® ® • multiroom IVF incubator serial number (S/N) and customer. -
Page 93: User Training
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 94: 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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