1. Manuals
  2. Brands
  3. Esco Medical Manuals
  4. Medical Equipment
  5. MIRI II-12
  6. User manual

Esco Medical MIRI II-12 User Manual

Multiroom ivf incubators
Hide thumbs Also See for MIRI II-12:
Table of Contents

Advertisement

Quick Links

Download this manual
For research
use only
USER MANUAL
MIRI
II-12 Multiroom
®
IVF Incubators
Rev. 4.0
Date of revised 06.10.2021
Rx only

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the MIRI II-12 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Esco Medical MIRI II-12

Summary of Contents for Esco Medical MIRI II-12

  • Page 1 For research use only USER MANUAL MIRI II-12 Multiroom ® IVF Incubators Rev. 4.0 Date of revised 06.10.2021 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 (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 II-12 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 .......................... 10 2 Safety warning ............................10 3 Indication for use ............................10 4 About the product ............................ 11 5 Transport, Storage and Disposal ......................12 5.1 Transportation requirements ..................... 12 5.2 Storage and operation environment requirements ............
  • Page 7 13.5.5 O calibration menu ......................31 13.5.6 Running mode page......................32 14 Alarms ................................ 33 14.1 Temperature alarms ........................33 14.2 Gas level alarms ..........................34 14.2.1 CO alarms ..........................34 14.2.2 O alarms ..........................34 14.3 Gas pressure alarms ........................35 14.3.1 CO pressure alarm .......................
  • Page 8 26 Alarm switch for an external system ....................50 27 Writing area on the compartment lids ..................51 28 Maintenance ............................51 29 Emergency procedures ........................52 30 User troubleshooting ..........................54 31 Specifications............................56 32 Electromagnetic compatibility ......................57 33 The Validation guide ..........................
  • Page 9 35.13.1 A VOC meter.......................... 69 35.13.2 A laser particle counter ....................69 36 Clinical use ..............................70 36.1 Temperature check ........................70 36.2 CO gas concentration check ..................... 70 36.3 O gas concentration check ......................71 36.4 CO gas pressure check ....................... 72 36.5 N gas pressure check ........................

  • Page 10: How To Use This Manual

    • If the equipment is used in a manner not specified by this manual, the protection provided by this equipment may be impaired. 3 Indication for use The Esco Medical MIRI family`s multiroom IVF incubators are intended to be used to pro- ®...

  • Page 11: About The Product

    (IVF) / assisted reproduction technology (ART) treatments. 4 About the product Esco Medical MIRI II-12 multiroom IVF incubator is a CO incubator. ® Direct warming of the dishes in the chambers gives superior temperature conditions in comparison to conventional multiroom IVF incubators.

  • Page 12: Transport, Storage And Disposal

    The multiroom IVF incubator has been primarily developed and designed for incubation of gametes and embryos with an overlay of either Paraffin or mineral oil. The multiroom IVF incubator has a built-in PC which operates the Esco Medical Data logger software for long-term data logging and data storage.

  • Page 13: Storage And Operation Environment Requirements

    A visual inspection should be done if there is any damage. If no damage is found, the MIRI ® II-12 multiroom IVF incubator can be prepared for transport. These labels should be glued on the box: • Label with the marked packing date •...

  • Page 14: Supplied Service Parts And Accessories

    Please note that the VOC/HEPA and HEPA filters must be discarded following the applicable national regulations for special solid waste. 6 Supplied service parts and accessories Service parts: • 1 VOC/HEPA filter capsule • 2 HEPA filters for input gas supply •...
  • Page 15 Table 7.2 Device and “For research use only” labels Description Image 1. Model. 2. Mains power rating. 3. CE mark. 4. Not protected against the ingress of water. 5. Manufacturer’s address and country of origin. 6. View instruction for use. 7.

  • Page 16: 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 17: Post Installation

    0.4 – 0.6 bar (5.80 – 8.70 PSI). 11. Never use any other except Esco Medical filter. Otherwise, the warranty will be void. 12. Do not use the device without a proper Esco Medical VOC/HEPA filter attached.

  • Page 18: Mains Connection

    5. Set the gas pressure on the external gas regulator at 0.4 – 0.6 bar (5.80 – 8.70 PSI). 6. Switch on the MIRI II-12 multiroom IVF incubator in the back. ® 7. Observe for standard functionality. 8. Let the unit warm up and stabilize for 20 min. 9.
  • Page 19 Figure 11.1 Gas inlets on the back of the MIRI II-12 ® multiroom IVF incubator inlet should be connected to a 100% concentration of CO . CO control in the compartment is available in the range from 3.0% to 10.0%. inlet should be connected to a 100% concentration N if low oxygen conditions are required.

  • Page 20: Hepa/Voc Filter

    12 HEPA/VOC filter 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 . It is essential to use in-line VOC filters to prevent these fumes from entering your multiroom IVF incubators for your medical gasses.

  • Page 21: User Interface

    Figure 12.1 The flow arrow on the incubator Figure 12.2 The direction of pulling the 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 22: Activating The Heat And Gas Controls

    Table 13.1 The main keys and their purpose Description Image Main keys ON/OFF keys It is located in the REAR of the unit. key turns on the device and 2 turns on the PC. Alarm key It mutes an audible alarm and visually indicates the alarm condition by a flashing red circle of light.

  • Page 23: Temperature Setpoint

    Temperature Temperature running mode Figure 13.1 Main display view 13.2 Temperature setpoint The temperature setpoint can be adjusted in the range from 25.0 °C to 40.0 °C. The default temperature setpoint is 37.0 °C. To change the temperature setpoint, please follow these instructions: 1.

  • Page 24: Changing The Co 2 Concentration Setpoint

    Figure 13.3 Setpoint for compartment 1 view When using the multi-setpoint, the multi-setpoint must be chosen in the operation mode. When the setpoint is set, press the (◁) key. Figure 13.4 Operation mode view If the “SINGLE“ temperature setpoint is set, then the value will be applied to all compartments.

  • Page 25: Changing The O 2 Concentration Setpoint

    Figure 13.5 Main display view 2. Press (+) or (-) keys to adjust the CO setpoint. In the picture below, the setpoint for is chosen. Figure 13.6 CO setpoint view 13.4 Changing the O concentration setpoint The O setpoint can be adjusted in the range from 5.0% to 10.0%. The default O setpoint is 5.0%.
  • Page 26 Figure 13.7 Main display view 2. Press (+) or (-) keys to adjust the O setpoint. In the picture below, the setpoint for is chosen: Figure 13.8 O setpoint view 3. Press the SETUP key in the “O setpoint” page to turn the O regulation ON/OFF.

  • Page 27: System Menu

    13.5 System menu Press the SETTINGS key to enter the menu. The key is located on the right top side of the main display: Figure 13.10 Setup key location view Press the RUNNING MODE key to enter the mode setting. The key is located on the left bottom side of the main display: Figure 13.11 Running mode key location on the main display Press the LOGGER key to enter the data logger.

  • Page 28: General Menu Page

    Press the pH key to enter pH measuring. The key is located on the top of the main display: Figure 13.14 pH measuring key location on the main display Press the REPORT EXPORT key to enter data-logging graphs. The key is located on the top of the main display: Figure 13.15 Report export key location on the main display 13.5.1 General menu page...

  • Page 29: Calibration Menu

    13.5.2 Calibration menu The calibration menu page is shown below: Figure 13.18 Calibration menu view • Press the TEMPERATURE key to enter the temperature calibration page. • Press the CO key to enter the CO calibration page. • Press the O key to enter the O calibration page.

  • Page 30: Co Calibration Menu

    Adjust the temperature by pressing the (+) key 5 times when T1 is chosen. The display will show the steps from 36.9 °C, 37.0 °C, 37.1 °C, 37.2 °C, 37.3 °C and 37.4 °C. The value is now stored and T1 sensor calibration is modified. The calibration procedure is the same for T1 –...

  • Page 31: O 2 Calibration Menu

    Calibration is performed by adjusting the CO level according to the measurement taken from the gas sampling outlet by an external reliable CO measurement device. Calibration values should only be changed by a trained user or the technician, according to specific measurements. Done with the calibrated device. Adjust the calibration to the desired level by pressing the (+) and (-) keys.

  • Page 32: Running Mode Page

    according to specific measurements. Done with the calibrated device. Adjust the calibration to the desired level by pressing the (+) and (-) keys. In this case, the goal is to adjust to O gas levels to 5.3%. The display will show 5.0, 5.1, 5.2, and 5.3%. The new value is now stored and O sensor calibration is modified.

  • Page 33: Alarms

    individual compartments). 2. Press the (◁) key to return to the main page. 14 Alarms On fault condition, the display will show the values in red. An audio signal will go off, but it can be muted by pressing the ALARM key once (toggled on/off for 5 minutes). An arrow will also appear and it will indicate whether the alarm is triggered due to too high or too low values.

  • Page 34: Gas Level Alarms

    If the mute key is pressed, the display will still show a red value and the sound will be muted for 5 minutes until the audio alarm goes off again. The mute alarm key will still show the alarm condition by blinking red when the alarm is muted. 14.2 Gas level alarms 14.2.1 CO alarms...

  • Page 35: Gas Pressure Alarms

    Figure 14.4 High O concentration alarm view on the main display The percentage of O 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 still show a red value and the sound will be muted for 5 minutes until the audio alarm goes off again.

  • Page 36: Pressure Alarm

    14.3.2 N pressure alarm If the N gas supply is not attached correctly or incorrect N gas pressure is applied to the system, the MIRI II-12 multiroom IVF incubator will go into N pressure alarm mode. N ® pressure will be displayed in red, indicating the wrong 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.

  • Page 37: Multiple Alarms

    14.5 Multiple alarms In the picture below, in compartment 6 the temperature is too high, the CO is not connected, or the CO pressure is incorrect and there is also a UV-C light malfunction. Figure 14.8 Multiple alarm view on the main display When there are multiple affected parameters, all of them will appear red in the display.
  • Page 38 Figure 15.1 Temperature zones in the MIRI II-12 multiroom IVF incubator ® 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 the following: T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19, T20, T21, T22, T23 and T24.

  • Page 39: Pressure

    Be careful when changing the calibration settings – make sure that only the altered value corresponds to where the measurement is done. Give the system some time to adjust. There is no crossover heating between the 12 compartments: This is a unique feature of the MIRI II-12 incubator.

  • Page 40: Firmware

    Figure 16.2 O pressure on the main display The N pressure value is shown in bar. The external pressure must be between 0.4 – 0.6 bar (5.80 – 8.70 PSI) at all times. It cannot be adjusted on the incubator; this must be done on the external gas regulator.
  • Page 41 According to the temperature level set in the calibration dialogue window on the screen, the system does temperature correction (ATC) according to the calibration dialogue window's temperature level. An external ATC probe cannot be used with the system. Figure 18.1 BNC pH line connection The temperature level must be set to a correct level in the calibration dialogue window on the screen (corresponding to a measurement done with an external device).
  • Page 42 Figure 18.3 4-well dish with 3 buffers and media For calibration, at least two buffers are needed. We recommended using 3 buffers. One of the buffers should have a 7 pH. Any pH buffer can be used as the user's buffer levels can be set in the calibration dialogue window.

  • Page 43: Safe Sense Function

    After the calibration is performed and saved, quick pH measurement can be done in the culture media. Ensure the probe tip is well covered with media and that the opening through the test lid is sealed sufficiently to maintain gas levels (use tape or rubber seal). The set-up can measure the pH continually.

  • Page 44: Data-Logging Co 2 View

    The history view allows for seeing temperature data graphs. It is possible to toggle ON/OFF compartment graphs 1-12 in the MIRI II-12 multiroom IVF incubator by pressing the cor- ® responding circled number. With the period buttons “Hour”, “Day”, “Week” and “2 weeks”, it is possible to change the viewing period.

  • Page 45: Data-Logging Alarm View

    Figure 20.3 O data graph 20.4 Data-logging alarm view By pressing the alarm bell button, the alarm view opens up. The alarm view depicts all the parameters and any alarm statuses in a quick graphical overview. A red block represents each alarm –...

  • Page 46: Cleaning Procedure Recommended By The Manufacturer

    However, the device's 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 47: Heat Optimization Plates

    The use of gloves and good handling techniques are essential for successful disinfection. Proceed with the following steps (this procedure has been demonstrated during the on-site training program as part of the installation protocol): 1. Power off the MIRI II-12 multiroom IVF incubator (rear panel). ®...

  • Page 48: Humidification

    Figure 22.2 Heat optimization plates (SAFE Sense version) Never incubate without the plates in place and never use non-Esco Medical heating optimization plates. This may cause dangerous and unpredictable temperature conditions that may be harmful to the specimens. 23 Humidification...

  • Page 49: Gas Level Validation

    Temperature conditions in the compartments 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 50: Alarm Switch For An External System

    26 Alarm switch for an external system In order to connect the MIRI II-12 multiroom IVF incubator to an external monitoring ® system and ensure maximum safety, especially during nights and weekends, the incubator is equipped with a 3.5 mm jack connector on the back, which can be connected to a monitoring device.

  • Page 51: Writing Area On The Compartment Lids

    Figure 26.2 “Open circuit” alarm mode Whenever the incubator’s power cord is disconnected from the power source, this switch will automatically indicate an alarm! 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 compartment lids Each compartment lid on the MIRI II-12 multiroom IVF incubator is made from white glass,...

  • Page 52: Emergency Procedures

    2. VOC/HEPA filters must be replaced every 3 months. 3. In-line HEPA filters must be replaced yearly during annual maintenance. 4. Suitable cleaning, according to the intervals prescribed by the clinical practice in the laboratory where the MIRI II-12 multiroom IVF incubator is in use. The ®...
  • Page 53 • Alternatively, remove the samples from all the affected compartments and place them in an alternative or backup device that is not affected by the problem. If the CO level alarm goes off: There will be a 30-minute long interval during which the user can assess if the condition is temporary or permanent.

  • Page 54: User Troubleshooting

    30 User troubleshooting Table 30.1 Heating system Symptom Cause Action The unit is switched off at the back or Switch on the device or connect to No heating, the display is off not connected to the power source the power source Check the desired temperature No heating The temperature setpoint is incorrect...
  • Page 55 Table 30.3 O gas regulator Symptom Cause Action No O gas regulation The system is not powered Check the power mains The system is on standby or switched Switch the system on Activate the O gas regulator by gas regulator is off setting “O2”...

  • Page 56: Specifications

    31 Specifications Table 31.1 The MIRI II-12 multiroom IVF incubator specifications ® Technical specifications MIRI II-12 ® Overall dimensions (W x D x H) 740 × 575 × 215 mm Weight 47 kg Material Mild steel / Aluminum / PET / Stainless steel Power supply 115V 60Hz or 230V 50Hz Power consumption...

  • Page 57: Electromagnetic Compatibility

    32 Electromagnetic compatibility Table 32.1 Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The MIRI II-12 multiroom IVF incubators are intended for use in the electromagnetic environment ® specified below. The customer or the user of the MIRI II-12 multiroom IVF incubator should ensure that it is ®...
  • Page 58 Power frequency The power-frequency magnetic (50/60 Hz) fields' levels should Performance magnetic field 3 A/m characteristic specific location in a typical commercial IEC 61000-4-8 or hospital environment Guidance and manufacturer’s declaration – electromagnetic immunity The MIRI II-12 multiroom IVF incubators are intended for use in the electromagnetic environment ®...
  • Page 59 Separation distance according to the frequency of the transmitter (m) The rated maximum output power of the 150 kHz to 80 80 MHz to 800 800 MHz to 2.5GHz transmitter MHz d = 1.2√P MHz d = 1.2√P d = 2.3√P 0.01 W 0.1m 0.1m...

  • Page 60: The Validation Guide

    33 The Validation guide 33.1 Product release criteria The Esco Medical MIRI II-12 multiroom IVF incubator undergoes strict quality and ® performance testing before being released for sale. 33.1.1 Performance Each component used in the MIRI II-12 multiroom IVF incubator is tested during the ®...

  • Page 61: Cosmetic

    34 Validation on-site Even though at Esco Medical, we strive to do the most comprehensive tests before the device is shipped to the customer, there is no way to be sure that everything is still OK at the location when the device is set up.

  • Page 62: Recommended Additional Equipment

    • A Multimeter. 34.2 Recommended additional 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 II-12 ®...

  • Page 63: Gas Supply N

    exist in both a gaseous and a liquid state. Bulk liquid carbon dioxide is commonly maintained as a refrigerated liquid and vapor at pressures between 1,230 kPa (approx. 12 bar) and 2,557 kPa (approx. 25 bar). Carbon dioxide may also exist as a white opaque solid with a temperature of -78.5 °C under atmospheric pressure.

  • Page 64: About N

    Sample from the bottle near the bottom with the gas analyzer. A gas analyzer that can measure 0% O accurately can be used. 100% N = 0 % O PASS: N concentration measured must be between 95.0%– 100%. The use of N gas with moisture will damage the flow sensors.

  • Page 65: N 2 Gas Pressure Check

    device. PASS: The value must be 0.4 – 0.6 bar. Please refer to the User manual sections for more information. 35.4 N gas pressure check The MIRI II-12 multiroom IVF incubator requires a pressure of 0.4 – 0.6 bar (5.80 – 8.70 ®...

  • Page 66: O 2 Gas Concentration Check

    The gas analyzer must have a gas return port connected to the multiroom IVF incubator (i.e., another compartment). Only measure while the value on the gas analyzer stabilizes. Please refer to the "13.5.4 CO calibration menu" section for more information on how to perform the CO gas calibration.

  • Page 67: Temperature Check: Compartment Lids

    Let the incubator warm the dishes and stabilize for at least 1-hour. Open a compartment lid, remove the cover from the dish and place the sensor tip inside the droplet. If the measuring device has a fast response time (less than 10 seconds), the quick droplet measurement method should give a useful result.

  • Page 68: 6-Hour Stability Test

    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 69: Test Documentation Form

    • Let the incubator run empty for at least 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...

  • Page 70: Clinical Use

    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. It should provide many years of stable service. It is necessary to monitor the performance of the device continually.

  • Page 71: O 2 Gas Concentration Check

    II-12 multiroom IVF incubator 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 MIRI II-12 Multiroom IVF incubators User Manual Rev. 4.0...

  • Page 72: Co Gas Pressure Check

    local distributor for further guidance. 36.4 CO gas pressure check The MIRI II-12 multiroom IVF incubator requires a pressure of 0.4 – 0.6 bar on the input ® gas line. This gas pressure must be held stable at any time. For safety reasons, this unit has a built-in digital gas pressure sensor control that monitors the incoming gas pressure and alerts the user if any drop is detected.

  • Page 73: The Maintenance Guide

    Please refer to the "18 pH measuring" section for more information on performing pH calibration. 37 The Maintenance guide Your MIRI II-12 multiroom IVF incubator from Esco Medical contains high precision quality ® components. These components are chosen to ensure the high durability and performance of the equipment.

  • Page 74: Voc/Hepa Filter Capsule

    II-12 multiroom 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 75: In-Line Hepa Filter For Co

    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 CO gas.

  • Page 76: 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 77: Uv Light

    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 78: Internal Gas Pump

    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 79: Flow Sensors

    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 80: Internal 0.2Μ Filter For Co Gas

    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 CO gas.

  • Page 81: Firmware Update

    37.15 Firmware update If Esco Medical has released a newer version of the firmware, this should be installed on the MIRI II-12 multiroom IVF incubator during the yearly scheduled service. ® Please refer to the service manual for instructions on how to update the firmware.

  • Page 82: Preparing For Installation

    2. The MIRI II-12 multiroom IVF incubator weight is approximately 47 kg. ® 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 exceed- ing 30 °C. 5.

  • Page 83: User Training

    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 84 written "Installation report". The completed and signed "Installation report" form must be sent to the clinic. Any deviations/complaints/suggestions from the Installation visit are reported in the CAPA system. If a critical error has occurred, information about this will be reported directly to QC or QA. If the MIRI II-12 multiroom IVF incubator fails any of the "Installation report"...

Table of Contents