Esco Medical CE 0123 User manual

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

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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Esco Medical Technologies, UAB
Draugystes g. 19 •Kaunas, Lithuania
Tel [phone]
www.esco-medical.com •[email protected]
For Technical Service, contact
Europe
Esco Medical Technologies, UAB
Draugystes g. 19 •Kaunas, Lithuania
Tel [phone]
www.esco-medical.com •[email protected]
North America
Esco Technologies, Inc.
903 Sheehy Drive, Suite F, Horsham, PA 19044, USA
Tel [phone] •Fax [phone]
www.escolifesciences.us •[email protected]
Rest of the World
Esco Micro Pte. Ltd.
21 Changi South Street 1 •Singapore 486 777
Tel [phone] •Fax [phone]
www.escolifesciences.com •[e-mail]
Copyright Information
© Copyright 2014 Esco Micro Pte Ltd. All rights reserved.
The information in this manual and the accompanying product is copyrighted and all rights are
reserved by Esco.
Esco reserves the right to make periodic minor design changes without obligation to notify any
person or entity of such change.
Sentinel™ is a registered trademark of Esco.
Caution: Federal law restricts this device to sale by or on a licensed healthcare practitioner's order.
Only to be used by a trained and qualified professional. The device is sold under exemption 21 CFR
801 Subpart D.
"Material in this manual is provided for informational purposes only. The contents and the product
described in this manual (including any appendix, addendum, attachment or inclusion) are subject to
change without notice. Esco makes no representations or warranties as to the accuracy of the
information contained in this manual. In no event shall Esco be held liable for any damages, direct or
consequential, arising out of or related to the use of this manual.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping
carton for damage. If the damage is found, stop unpacking the instrument. Notify the
freight carrier and ask for an agent to be present while the instrument is unpacked. There
are no special unpacking instructions, but be careful not to damage the instrument when
unpacking it. Inspect the instrument for physical damage such as bent or broken parts,
dents, or scratches.
Claims
Our routine method of shipment is via common carrier. If physical damage is found, upon
delivery, retain all packing materials in their original condition and immediately contact
the carrier to file a claim.
If the instrument 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 immediately.
Standard Terms and Conditions
Refunds & Credits
Please note only serialized products (products labeled with a distinct serial number) and
accessories are eligible for a partial refund and/or credit. Non-serialized parts and
accessory items (cables, carrying cases, auxiliary modules, etc.) are not eligible for return
or refund. In order to receive a partial refund/credit, the product must not have been
damaged. It must be returned complete (meaning all manuals, cables, accessories, etc.)
within 30 days of original purchase, in "as new" and resalable condition. The Return
Procedure must be followed.
Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material
Authorization (RMA) number obtained from Esco Medical Customer Service. All items
being returned must be sent prepaid (freight, duty, brokerage and taxes) to our factory
location.
Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum
restocking fee of 20% of the list price. Additional charges for damage and/or missing
parts and accessories will be applied to all returns. Products that are not in "as new" and
resalable condition are not eligible for credit return and will be returned to the customer
at their own expense.
Certification
This instrument has been thoroughly tested/inspected and found to meet Esco Medical's
manufacturing specifications when shipped from the factory. Calibration measurements
and testing are traceable and done according to Esco Medicals ISO certification.
Warranty and Product Support
Esco Medical warrants this instrument 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 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. 6.1
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that proves to be defective at no charge, provided you return the product (shipping, duty,
brokerage and taxes prepaid) to Esco Medical. Any transportation charges incurred are
the purchaser's responsibility and are not included within this warranty. This warranty
extends only to the original purchaser. It does not cover damage from abuse, neglect,
accident or misuse, or as the result of service or modification by parties other than Esco
Medical.
IN NO EVENT SHALL ESCO MEDICAL LTD. BE LIABLE FOR CONSEQUENTIAL DAMAGES.
No warranty shall apply when any of the following causes damage:
•Power failure, surges, or spikes
•Damage in transit or when moving the instrument
•An improper power supply such as low voltage, incorrect voltage, defective wiring
or inadequate fuses
•Accident, alteration, abuse or misuse of the instrument
•Fire, water damage, theft, war, riot, hostility, acts of God such as hurricanes, floods,
etc.
Only serialized products (those items bearing a distinct serial number tag) and their
accessory items are covered under this warranty.
PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER
THE WARRANTY. Items such as cables and non-serialized modules are not covered under
this warranty.
This warranty gives you specific legal rights and you may have other rights, which vary
from province to province, state to state, or country to country. 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:
•Use a double-walled carton of sufficient strength for the weight being shipped
•Use heavy paper or cardboard to protect all instrument surfaces. Use non-abrasive
material around all projecting parts
•Use at least four inches of tightly packed, industrial-approved, shock-absorbent
material all around the instrument
Esco Medical will not be responsible for lost shipments or instruments received in
damaged condition due to improper packaging or handling. All warranty claim shipments
must be made on a prepaid basis (freight, duty, brokerage, and taxes). No returns will be
accepted without a Return Materials Authorization ("RMA") number. Please contact Esco
Medical to obtain an RMA number and receive help with shipping/customs
documentation.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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Re-calibration of instruments, which have a recommended annual calibration frequency,
is not covered under warranty.
Warranty Disclaimer
If your instrument is serviced and/or calibrated by someone other than Esco Medical Ltd.
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.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as
this seal is key to your original instrument warranty. 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. You should break this seal only after you have
received factory authorization. Do not break the Quality Seal before you have contacted
us! Following these steps will help ensure that you will retain the original warranty on
your instrument without interruption.
WARNING
Unauthorized user modifications or applications beyond the published specifications
may result in an electrical shock hazard or improper operation. Esco Medical will not be
responsible for any injury sustained due to unauthorized equipment modifications.
ESCO MEDICAL LTD. DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION.
THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.
UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL
OTHER EXPRESSED OR IMPLIED WARRANTIES.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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 ............................................................................................................14
5.2.2 Operation environment requirements............................................................................15
5.3 Disposal................................................................................................................................................15
6 Supplied service parts and accessories ...........................................................................................15
7 Safety symbols and labels .....................................................................................................................16
8 Important safety instructions and warnings.................................................................................19
8.1 Before installation ...........................................................................................................................19
8.2 During installation...........................................................................................................................19
8.3 Post installation................................................................................................................................19
9 Getting started...........................................................................................................................................20
10 Mains connection...................................................................................................................................21
11 Gas connections......................................................................................................................................21
12 HEPA / VOC filter (applicable only for the MIRI®model) .....................................................23
12.1 Installation of new filter capsule.............................................................................................23
13 User interface..........................................................................................................................................25
13.1 Activating the heat and gas controls......................................................................................26
13.2 System menu...................................................................................................................................26
13.3 Status..................................................................................................................................................26
13.4 Main menu .......................................................................................................................................27
13.4.1 Temperature sub-menu .....................................................................................................28
13.4.2 CO2 sub-menu .........................................................................................................................29
13.4.3 O2sub-menu............................................................................................................................30
13.4.4 UVC light sub-menu (applicable only for the MIRI®model)................................32
13.4.5 Service sub-menu..................................................................................................................32

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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 CO2alarms ...............................................................................................................................38
15.2.2 O2alarms..................................................................................................................................38
15.3 Gas pressure alarms.....................................................................................................................39
15.3.1 CO2pressure alarm ..............................................................................................................39
15.3.2 N2pressure alarm.................................................................................................................40
15.4 Multiple alarms ..............................................................................................................................40
15.5 Alarm UVC light (applicable only for the MIRI®model) ................................................40
15.6 Loss of power alarm.....................................................................................................................41
15.7 Summary of the alarms...............................................................................................................41
15.8 Alarm verification .........................................................................................................................42
16 Changing the set points .......................................................................................................................42
16.1 The temperature set point.........................................................................................................42
16.2 The CO2gas concentration set point......................................................................................43
16.3 The O2gas concentration set point.........................................................................................43
16.4 The culture mode ..........................................................................................................................44
17 Surface temperatures and measuring temperature.................................................................45
18 Pressure.....................................................................................................................................................47
18.1 CO2gas pressure............................................................................................................................47
18.2 N2 gas pressure...............................................................................................................................47
19 Firmware...................................................................................................................................................48
20 pH measuring..........................................................................................................................................48
21 SAFE Sense function .............................................................................................................................51
22 Cleaning instructions ...........................................................................................................................51
22.1 Considerations about a sterile device ...................................................................................51
22.2 Manufacturer recommended cleaning procedure............................................................52
22.3 Manufacturer recommended disinfection procedure.....................................................52
23 Heat optimization plates.....................................................................................................................53

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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..........................................................................................58
29 Maintenance ............................................................................................................................................58
30 Emergency Procedures........................................................................................................................59
31 User Troubleshooting ..........................................................................................................................61
32 Specifications...........................................................................................................................................63
33 Electromagnetic compatibility .........................................................................................................64
34 The Validation guide.............................................................................................................................67
34.1 Product release criteria ..............................................................................................................67
34.1.1 Performance............................................................................................................................67
34.1.2 Electrical safety......................................................................................................................67
34.1.3 Communication & data logging .......................................................................................67
34.1.4 Gas concentration levels and consumption................................................................67
34.1.5 Cosmetic ...................................................................................................................................68
35 Validation on-site...................................................................................................................................68
35.1 Mandatory equipment.................................................................................................................68
35.2 Recommended additional equipment...................................................................................69
36 Testing .......................................................................................................................................................69
36.1 Gas supply CO2................................................................................................................................69
36.1.1 About CO2.................................................................................................................................70
36.2 Gas supply N2..................................................................................................................................71
36.2.1 About N2...................................................................................................................................71
36.3 CO2gas pressure check ...............................................................................................................72
36.4 N2gas pressure check..................................................................................................................72
36.5 Voltage supply ................................................................................................................................72
36.6 CO2gas concentration check.....................................................................................................73
36.7 O2gas concentration check .......................................................................................................73
36.8 Temperature check: Compartment bottoms ......................................................................74

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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
36.13.2 A laser particle counter....................................................................................................77
37 Clinical use................................................................................................................................................77
37.1 Temperature check.......................................................................................................................78
37.2 CO2gas concentration check.....................................................................................................78
37.3 O2gas concentration check .......................................................................................................79
37.4 CO2gas pressure check ...............................................................................................................79
37.5 N2gas pressure check..................................................................................................................80
37.6 pH check............................................................................................................................................80
38 The Maintenance guide .......................................................................................................................80
38.1 VOC/HEPA filter capsule (applicable only for the MIRI®model)...............................82
38.2 Humidification bottle (applicable only for the MIRI®Humidity model).................82
38.3 In-line HEPA filter for CO2gas..................................................................................................82
38.4 In-line HEPA filter for N2gas ....................................................................................................83
38.5 O2sensor...........................................................................................................................................83
38.6 CO2sensor........................................................................................................................................84
38.7 UV light (applicable only for the MIRI®model) ................................................................84
38.8 Cooling fan .......................................................................................................................................85
38.9 Internal gas pump (applicable only for the MIRI®model)............................................85
38.10 Pump module (applicable only for the MIRI®Humidity model) .............................86
38.11 Proportional valves....................................................................................................................86
38.12 Gas lines..........................................................................................................................................87
38.13 Flow sensors.................................................................................................................................87
38.14 Pressure regulators....................................................................................................................88
38.15 Internal 0.2µ filter for CO2gas...............................................................................................88
38.16 Internal 0.2µ filter for N2gas..................................................................................................88
38.17 Firmware update ........................................................................................................................89
39 The Installation guide ..........................................................................................................................89

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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. 6.1
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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. We recommend the following method for going through the manual: first,
familiarize yourself with the safety instructions; then, proceed to the essential user
functions that are needed for operating the equipment on a day-to-day basis; then, review
the alarm functions. The menu functions of the user interface detail information that is
required only for advanced users. All parts must be read before the device is taken into
use. The Validation guide is detailed described in sections 34 –37. The Maintenance guide
is detailed described in section 38. The Installation procedures are detailed described in
section 39.
2 Safety warning
•Anyone working with, on or around this equipment should read this manual.
Failure to read, understand and follow the instructions given in this
documentation may result in damage to the unit, injury to the operating personnel
and/or poor equipment performance
•Any internal adjustment, modification or maintenance to this equipment must be
undertaken by qualified service personnel.
•If the equipment must be relocated, make sure it is appropriately fixed on a
support stand or base and move it on a flat surface. When necessary, move the
equipment and the support stand/base separately.
•The use of any hazardous materials in this equipment must be monitored by an
industrial hygienist, safety officer or other suitably qualified individuals.
•Before you proceed, you should thoroughly understand the installation
procedures and note the environmental/electrical requirements.
•In this manual, important safety-related points will be marked with the following
symbols:
NOTE
Used to direct attention to a specific item.
WARNING
Use caution.
•If the equipment is used in a manner not specified by this manual, the protection
provided by this equipment may be impaired.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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 CO2/N2or
premixed gases and humidification for the development of gametes and embryos during
in vitro fertilization (IVF) / assisted reproduction technology (ART) treatments.
4 About the product
The Esco Medical MIRI®and MIRI®Humidity multiroom IVF incubators are CO2/O2gas
incubators.
Direct warming of the dishes in the chambers gives superior temperature conditions in
comparison to conventional multiroom IVF incubators.
The temperature in the compartment will remain stable up to 1 °C (even when a lid is
open for 30s) and will recover within 1 min after the lid is closed.
The Esco Medical MIRI®and MIRI®Humidity multiroom IVF incubators have 6
completely separate culture heat chambers. Each chamber has its own heated lid and
warming plate for Petri dish. MIRI®and MIRI®Humidity capacity for 35 mm Petri dish is
48 pcs and for 60 mm and 4-well Petri dishes –24 pcs.
To ensure maximum performance, the system of MIRI®and MIRI®Humidity multiroom
IVF incubator have 12 completely separate PID temperature controllers. They control
and regulate temperature in culture chambers and lids. Compartments do not affect each
other's temperatures in any way. The top and the bottom of each compartment is
separated with a PET layer so that the lid temperature would not affect the bottom. For
validation purposes, each compartment has a PT-1000 sensor built in. The circuitry is
separated from the unit's electronics so it remains a truly separate validation system.
The MIRI®and MIRI®Humidity multiroom IVF incubator needs 100% CO2and 100% N2
or premixed gas (for instance 5% CO2; 5% O2and 90% N2) in order to be able to control
the CO2and O2concentrations in the culture chambers.
A dual beam infrared CO2sensor with extremely low drift rates controls the CO2level. A
chemical medical grade oxygen sensor controls the level of O2.
Gas recovery time is less than 3 min. after opening the lid. To validate gas concentration,
the MIRI®and MIRI®Humidity multiroom IVF incubator is fitted with 6 gas sample ports
that allow the user to sample gas from the individual compartment.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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The MIRI®and MIRI®Humidity multiroom IVF incubator features a recirculated gas
system where gas is continuously put into the compartment and taken out at the same
rate. Gas is cleaned via 254 nm UVC light with direct gas contact between the bulb and
gas, then through a VOC filter and through a HEPA filter. The UVC light has filters that
inhibit any 185 nm radiation that would produce dangerous ozone. The VOC filter is
located under the UVC light.
UVC light modules and HEPA-VOC filters are not applied in the MIRI®Humidity
multiroom IVF incubator.
Complete gas repletion in the system takes less than 5 min.
The total gas consumption is very low. Less than 2 l/h CO2and 5 l/h N2in use.
For safety reasons the MIRI®and MIRI®Humidity multiroom IVF incubator has a very
complete gas control system that consists of: pressure regulator (preventing dangerous
gas pressure problems), gas flow sensors (actual consumption can be accumulated), gas
pressure sensors (then user knows that the pressure and variation can be logged to avoid
dangerous conditions), gas filters (to avoid valve problems).
Petri dish location in a compartment is easy to reach and safe because of the
compartment numbering and the ability to write on the white lid with a pen.
The MIRI®and MIRI®Humidity multiroom IVF incubator has been primarily developed
and designed for incubation of gametes and embryos with an overlay of either Paraffin
or mineral oil.
Refer to section "16.4 The culture mode" for more detailed information.
The upright LED display in MIRI®and MIRI®Humidity multiroom IVF incubators is large,
clear and easy to read from a distance. The user can tell if the parameters are correct
without going near the unit.
The user can plug any standard BNC pH probe to the unit and measure the pH in the
samples at will.
The MIRI®and 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
equipment that, once installed and placed into service, is not intended to be moved from

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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.
Personal Protective Equipment (89/686/EEC) and Machine Directive (2006/42/EC) is
not applicable for the MIRI®and MIRI®Humidity multiroom IVF incubators. Also, the
MIRI®and MIRI®Humidity multiroom IVF incubators do not contain or incorporates: a
medical substance, including a human blood or plasma derivate; tissues or cells, or their
derivates, of human origin; or tissues or cells of animal origin, or their derivatives, as
referred to in Regulation (EU) NO. 722/2012.
5 Transport, Storage and Disposal
5.1 Transportation requirements
The device is packed in a carton box, and it is wrapped in polyethylene. The box is affixed
to a pallet with special straps.
A visual inspection should be done if there is any damage. If no damage is found, the
MIRI®and MIRI®Humidity multiroom IVF incubator can be prepared for transport.
These labels should be glued on the box:
•Label with the marked packing date
•Label with the product name and serial number
5.2 Storage and operation environment requirements
5.2.1 Storage requirements
The device may only be store under the following conditions:
•The unit can be in storage for one year. If stored longer than one year, the unit
must be returned to the manufacturer for a new release test
•The unit can be stored at temperatures between -20 °C and + 50 °C
•Keep away from direct sunlight
•Caution: consult the accompanying documents for important safety-related
information such as warnings and precautions that cannot be presented on the
device itself for various reasons
•Do not use if the packing material is damaged

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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•Keep dry
5.2.2 Operation environment requirements
The device may only be used under the following conditions:
•Operating humidity: 5 –95% RH (Non-Condensing)
•Operating altitude –up to 2000 meters (6560 feet or 80kPa –106kPa)
•Non-operating altitude –more than 2000 meters (6560 feet or more than 80kPa
–106kPa)
•Environmental temperature: 18 –30 °C
•Away from direct sunlight
•Kept dry
•For indoor use only
5.3 Disposal
Information on handling of the unit as per the WEEE Directive (Waste Electrical and
Electronic Equipment).
The device may have been used for treating and processing infectious
substances. Therefore, the device and device components may be contaminated.
Prior to disposal, the whole device must be disinfected or decontaminated.
The unit contains reusable materials. All components (except for the VOC/HEPA and
HEPA filters) can be discarded as electrical waste after cleaning and disinfection.
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 (only for MIRI® model)
•1 humidity bottle (only for MIRI®Humidity model)
•1 bottle holder (only for MIRI®Humidity model)
•2 HEPA filters for input gas supply
•6 warming blocks
•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
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•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®Humidity multiroom IVF
incubators to guide the user. User labels are shown below.
Table 7.1 Packing box and electrical safety labels
Description
Image
Packing box label:
1. If stored longer than the shelf life, the unit must be
returned to the manufacturer for a new release test.
2. Shipping temperature between -20 °C and +50 °C.
3. Keep away from direct sunlight.
4. Caution: consult the accompanying documents for
important safety-related information such as
warnings and precautions that cannot, for a variety
of reasons, be presented on the device itself.
5. Consult instructions for proper use of the device.
6. Do not use if the packing material is damaged.
7. Rx Only.
8. Keep dry.
1. View the instructions for use.
2. Warning on the back of the device indicates that an
earth connection is needed, as well as the mains
information, and "ON/OFF" push button.
3. "Lightning bolt" indicates the potential risk of
electrical shock (never remove any cover).

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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. Serial number.
10. UDI-DI code.
11. Logo.
12. Keep away from direct sunlight.
13. Observe WEEE.
14. Keep dry.
15. Year of manufacture.
Table 7.3 Info labels on MIRI®and MIRI®Humidity multiroom IVF incubators
Description
Image
USB communication port
CO2inlet
N2inlet
BNC pH
Alarm port

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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.
It applies to USB connection.
Compartment numbers are shown in the picture below and also indicated on the top of
lids with label:
Figure 7.1 Compartment numbers on MIRI®multiroom IVF incubators
Figure 7.2 Compartment numbers on MIRI®Humidity multiroom IVF incubators
1
2
3
4
1
5
6
1
2
3
4
1
5
6

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
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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.
8.2 During installation
1. Never place this unit on top of other equipment that gives off heat.
2. Place this unit on a flat, hard and stable surface.
3. Do not place the unit on a carpet or similar surfaces.
4. Do not defeat the safety purpose of the grounding-type (earthing) plug.
5. A grounding-type (earthing) plug with two blades and a third prong are provided
for your safety. If the provided plug does not fit into your outlet, consult an
electrician to replace the outlet.
6. Always connect the power cord to a properly grounded outlet and only use the
cord that came with the device.
7. Do not install near any heat sources such as radiators, heat registers, stoves or
other apparatus that produce heat.
8. Do not use this device near water sources.
9. Use only 100% concentration CO2and 100% concentration N2gases.
10. Always use an external HEPA filter for input CO2and N2gases.
11. Do not use this product if the room temperature exceeds 30 °C.
12. Place this unit in a location with adequate ventilation to prevent internal heat
build-up. Leave at least 10 cm clearance from the rear, 30 cm from the top and 20
cm from left and right to prevent overheating and allow access to the ON/OFF
switch in the back.
13. This unit is intended for indoor purposes only.
14. The unit must be connected to a suitable uninterrupted power supply (UPS)
source.
8.3 Post installation
1. Refer all servicing procedures to qualified service personnel.
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®
and MIRI®Humidity multiroom IVF incubators contain high voltage components
that may be hazardous.

MIRI®and MIRI® Humidity multiroom IVF incubators User Manual Rev. 6.1
20
3. Unplug this device during lightning storms or when unused for an extended period
of time.
4. Protect the power cord from being walked on or pinched, particularly at the plug,
convenience receptacles and the point where it exits from the apparatus.
5. Perform temperature and gas calibration at the intervals described in the
manuals.
6. Never leave the lids open for more than 10 sec while in use.
7. VOC/HEPA filters must be changed every 3 months (do not apply for MIRI®
Humidity multiroom IVF incubator).
8. A maintenance plan must be fulfilled to keep the device safe.
9. NEVER block gas supply holes in the compartment.
10. Ensure that CO2and N2gas supply pressures are kept stable at 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).
9 Getting started
The MIRI®and MIRI®Humidity multiroom IVF incubators must be installed
by authorized and trained personnel only!
1. Follow the guidelines in the safety instructions and warnings section.
2. Connect the mains cable to the UPS.
3. Connect the mains cable to the MIRI®or 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. Switch on the MIRI®or MIRI®Humidity multiroom IVF incubator in the back.
7. Observe for standard functionality.
8. Let the unit warm up and stabilize for 20 min.
9. Follow the guidelines in the Validation guide (see section “34 The validation
guide”)
10. Complete user training and finish reading instructions.
11. After a burn-in phase of 24 hours, the unit is ready for use IF the testing is
successful.
Clean and disinfect the device before use. It is not delivered sterile or in a
clinically acceptable cleanliness state. Consult the cleaning instructions section in
this manual for the manufacturer's recommended guidelines!