Esco Medical MIRI MRI-6A10-H-8 User manual

Rev. 3.0
Date of Revised 06.10.2021
Rx only
MIRI®Humidity Multiroom IVF
incubators
USER MANUAL
For research
use only

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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Tel [phone] Fax [phone]
www.escolifesciences.us [email protected]
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Tel [phone] Fax [phone]

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The information contained 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 no-
tify any person or entity of such change.

Caution: Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Only to be used by a trained and qualified professional. The device is sold under exemp-
tion 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®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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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 spec-
ifications, or if there are any other problems not caused by shipping damage, please con-
tact 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 acces-
sory 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 dam-
aged. 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 Au-
thorization (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 restock-
ing 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 workman-
ship under regular use and service for two (2) years from the original purchase date, pro-
vided the instrument is calibrated and maintained following this manual. During the war-
ranty period, Esco Medical will, at our option, either repair or replace a product that

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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proves to be defective at no charge, provided you return the product (shipping, duty, bro-
kerage and taxes prepaid) to Esco Medical. Any transportation charges incurred are the
responsibility of the purchaser and are not included within this warranty. This warranty
extends only to the original purchaser. It does not cover damage from abuse, neglect, ac-
cident 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 ac-
cessory 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 rec-
ommend shipment using the original shipping foam and container. If the original packing
materials are not available, we recommend the following guide for repackaging:
•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 dam-
aged 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 documenta-
tion.

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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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 with-
out 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®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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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............................................................13
5.2.1 Storage requirements ............................................................................................................13
5.2.2 Operation environment requirements............................................................................13
5.3 Disposal................................................................................................................................................13
6 Supplied service parts and accessories ...........................................................................................14
7 Safety symbols and labels .....................................................................................................................14
8 Important safety instructions and warnings.................................................................................16
8.1 Before installation ...........................................................................................................................16
8.2 During installation...........................................................................................................................16
8.3 Post installation................................................................................................................................17
9 Getting started...........................................................................................................................................17
10 Mains connection...................................................................................................................................18
11 Gas connections......................................................................................................................................18
12 User interface..........................................................................................................................................19
12.1 Activating the heat and gas controls......................................................................................20
12.2 System menu...................................................................................................................................21
12.3 Status..................................................................................................................................................21
12.4 Main menu .......................................................................................................................................21
12.4.1 Temperature sub-menu .....................................................................................................22
12.4.2 CO2 sub-menu .........................................................................................................................23
12.4.3 O2sub-menu............................................................................................................................25
12.4.4 Service sub-menu..................................................................................................................26
13 Installation with premixed gas.........................................................................................................27
13.1 Installation procedure at the site............................................................................................27

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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13.2 User training....................................................................................................................................29
14 Alarms........................................................................................................................................................30
14.1 Temperature alarms ....................................................................................................................30
14.2 Gas level alarms .............................................................................................................................31
14.2.1 CO2alarms ...............................................................................................................................31
14.2.2 O2alarms..................................................................................................................................31
14.3 Gas pressure alarms.....................................................................................................................32
14.3.1 CO2pressure alarm ..............................................................................................................32
14.3.2 N2pressure alarm.................................................................................................................32
14.4 Multiple alarms ..............................................................................................................................33
14.5 Loss of power alarm.....................................................................................................................33
15 Changing the setpoints ........................................................................................................................33
15.1 The temperature setpoint..........................................................................................................33
15.2 The CO2gas concentration setpoint.......................................................................................34
15.3 The O2gas concentration setpoint..........................................................................................34
15.4 The culture mode ..........................................................................................................................35
16 Surface temperatures and measuring temperature.................................................................36
17 Pressure.....................................................................................................................................................37
17.1 CO2gas pressure............................................................................................................................37
17.2 N2 gas pressure...............................................................................................................................38
18 Firmware...................................................................................................................................................38
19 pH measuring..........................................................................................................................................39
20 SAFE Sense function .............................................................................................................................41
21 Cleaning instructions ...........................................................................................................................42
21.1 Considerations about a sterile device ...................................................................................42
21.2 Manufacturer recommended cleaning procedure............................................................42
21.3 Manufacturer recommended disinfection procedure.....................................................43
22 Heat optimization plates.....................................................................................................................43
23 Heat optimization plates.....................................................................................................................43
23 Humidification ........................................................................................................................................44
24 Temperature validation ......................................................................................................................44
25 Gas level validation ...............................................................................................................................45
26 Alarm switch for an external system .............................................................................................46

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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27 Writing area on the compartment lids..........................................................................................47
28 Maintenance ............................................................................................................................................47
29 Emergency Procedures........................................................................................................................48
30 User Troubleshooting ..........................................................................................................................50
31 Specifications...........................................................................................................................................52
32 Electromagnetic compatibility .........................................................................................................53
33 The Validation guide.............................................................................................................................56
33.1 Product release criteria ..............................................................................................................56
33.1.1 Performance............................................................................................................................56
33.1.2 Electrical safety......................................................................................................................56
33.1.3 Communication & data logging .......................................................................................56
33.1.4 Gas concentration levels and consumption................................................................56
33.1.5 Cosmetic ...................................................................................................................................57
34 Validation on-site...................................................................................................................................57
34.1 Mandatory equipment.................................................................................................................57
34.2 Recommended additional equipment...................................................................................58
35 Testing .......................................................................................................................................................58
35.1 Gas supply CO2................................................................................................................................58
35.1.1 About CO2.................................................................................................................................58
35.2 Gas supply N2..................................................................................................................................59
35.2.1 About N2...................................................................................................................................60
35.3 CO2gas pressure check ...............................................................................................................60
35.4 N2gas pressure check..................................................................................................................60
35.5 Voltage supply ................................................................................................................................61
35.6 CO2gas concentration check.....................................................................................................61
35.7 O2gas concentration check .......................................................................................................62
35.8 Temperature check: Compartment bottoms ......................................................................62
35.9 Temperature check: Compartment lids................................................................................63
35.10 6-hour stability test ...................................................................................................................63
35.11 Cleaning..........................................................................................................................................64
35.12 Test documentation form........................................................................................................65
35.13 Recommended additional testing ........................................................................................65
35.13.1 A laser particle counter....................................................................................................65

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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36 Clinical use................................................................................................................................................65
36.1 Temperature check.......................................................................................................................66
36.2 CO2gas concentration check.....................................................................................................66
36.3 O2gas concentration check .......................................................................................................66
36.4 CO2gas pressure check ...............................................................................................................67
36.5 N2gas pressure check..................................................................................................................67
36.6 pH check............................................................................................................................................68
37 The Maintenance guide .......................................................................................................................68
37.1 Humidification bottle...................................................................................................................69
37.2 In-line HEPA filter for CO2gas..................................................................................................69
37.3 In-line HEPA filter for N2gas ....................................................................................................70
37.4 O2sensor...........................................................................................................................................70
37.5 CO2sensor........................................................................................................................................71
37.6 Cooling fan .......................................................................................................................................71
37.7 Pump module..................................................................................................................................71
37.8 Proportional valves ......................................................................................................................72
37.9 Gas lines ............................................................................................................................................72
37.10 Flow sensors.................................................................................................................................73
37.11 Pressure regulators....................................................................................................................73
37.12 Internal 0.2µ filter for CO2gas...............................................................................................73
37.13 Internal 0.2µ filter for N2gas..................................................................................................74
37.14 Firmware update ........................................................................................................................74
38 The Installation guide ..........................................................................................................................74
38.1 Responsibilities..............................................................................................................................74
38.2 Before installation.........................................................................................................................75
38.3 Preparing for installation...........................................................................................................75
38.4 Bring the following to the installation site..........................................................................76
38.5 Installation procedure at the site............................................................................................76
38.6 User training....................................................................................................................................76
38.7 After the installation ....................................................................................................................77

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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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 33 36. The
Maintenance guide is detailed described in section 37. The Installation procedures are detailed
described in section 38.
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 under-
taken 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
It is 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.
3 Indication for use
The Esco Medical MIRI®family`s multiroom IVF incubators are intended to be used to pro-vide a
stable culture environment at or near body temperature and CO2/N2or premixed gases and hu-
midification for the development of gametes and embryos during in vitro fertilization (IVF) / as-
sisted reproduction technology (ART) treatments.

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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4 About the product
The Esco Medical MIRI®Humidity multiroom IVF incubators are CO2/O2gas incubators.
Direct warming of the dishes in the chambers gives superior temperature conditions in compari-
son 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®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®Hu-
midity 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®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 valida-
tion system.
The MIRI®Humidity multiroom IVF incubator needs 100% CO2and 100% N2or 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®
Humidity multiroom IVF incubator is fitted with 6 gas sample ports that allow the user to sample
gas from the individual compartment.
The MIRI®Humidity multiroom IVF incubator features a recirculated gas system where gas is con-
tinuously 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 dan-
gerous ozone. The VOC filter is located under the UVC light.
UVC light modules and HEPA-VOC filters are not applied in MIRI®Humidity multiroom IVF incu-
bator.
Complete gas repletion in the system takes less than 5 min.

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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The total gas consumption is very low. Less than 2 l/h CO2and 5 l/h N2in use.
For safety reasons the 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 num-
bering and the ability to write on the white lid with a pen.
The MIRI®Humidity multiroom IVF incubator has been primarily developed and designed for in-
cubation of gametes and embryos with an overlay of either Paraffin or mineral oil.
Refer to section “15.4 The culture mode” for more detailed information.
The upright LED display in 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.
A pH sensor port is part of the DAQ package. The user can plug any standard BNC pH probe to the
unit and measure the pH in the samples at will.
The 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.
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 equiv-
alent device suited for continuous operation. It also conforms to the requirements of the Regula-
tion (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 appli-
cable for the MIRI®Humidity multiroom IVF incubators. Also, the 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.

MIRI®Humidity Multiroom IVF incubators User Manual Rev. 3.0
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A visual inspection should be done if there is any damage. If no damage is found, the MIRI®Hu-
midity multiroom IVF incubator can be prepared for transport.

•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 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
•Keep dry
5.2.2 Operation environment requirements
The device may only be used under the following conditions:
•Environmental temperatures during regular use must not exceed 30 °C
•Away from direct sunlight
•Kept dry
•For indoor use only
5.3 Disposal
Information on the unit's handling 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. Before disposal, the
whole device must be disinfected or decontaminated.
The unit contains reusable materials. All components (except for the HEPA filters) can be dis-
carded as electrical waste after cleaning and disinfection.
Please note that the HEPA filters must be discarded following the applicable national regulations
for particular solid waste.

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6 Supplied service parts and accessories
•1 humidity bottle
•1 bottle holder
•2 HEPA filters for input gas supply
•6 warming blocks
•4 warranty labels
•1 pump box calibration tool
•1 USB stick containing Esco Medical Data logger software and a PDF version of the user
manual
•1 medical grade power cord
•1 3.5 mm external alarm jack connector
•1 set of fast male connectors with 15 silicone pipes
Accessories do not apply with the MIRI® Humidity multiroom IVF incubators.
7 Safety symbols and labels
There are several user labels on the surface of 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 warn-
ings and precautions that cannot be presented on the
device itself for various reasons.
5. Consult instructions for proper use of the device.
6. Do not use it 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 and the mains infor-
mation, and ON/OFFpush button.
3. Lightning boltindicates the potential risk of elec-
trical shock (never remove any cover).

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Table 7.2 Device and  research use  labels
Description
Image
1. Model.
2. Mains power rating.
3. CE mark.
4. Not protected against the ingress of water.
5.  address and country of origin.
6. View instruction for use.
7. Observe WEEE.
8. Upper limit of temperature.
9. Keep away from direct sunlight.
10. Keep dry.
11. Logo and serial number.
12. Year of manufacture.
13. Rx only.
1. For research use only.
Table 7.3 Info labels on the MIRI®Humidity incubator
Description
Image
USB communication port
CO2inlet
N2inlet
BNC pH
Alarm port
Compartments numbers are indicated in the
top corner of the lid with a label
Maximum pressure 0.8 bar
pH Safe sense
Gas sample ports
PT 1000 validation sensors

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Compartment numbers are shown in the picture below and also indicated on the top of lids with
labels:
Figure 7.1 Compartment numbers on MIRI®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 or the local repre-
sentative.
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 appa-
ratus 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.

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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®Humidity multiroom IVF incubators
contain high voltage components that may be hazardous.
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, conven-
ience 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. A maintenance plan must be fulfilled to keep the device safe.
8. NEVER block gas supply holes in the compartment.
9. Ensure that CO2and N2gas supply pressures are kept stable at 0.4 0.6 bar (5.80 8.70
PSI).
10. Never use any other except Esco Medical filter. Otherwise, the warranty will be void.
9 Getting started
MIRI®Humidity 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®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®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 3 The validation 
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!

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10 Mains connection
The MIRI®Humidity multiroom IVF incubators come with a detachable mains power cord. The
power cord is prepared for the country in which the unit is intended to be used.
The ON/OFF switch provides the user with a means to isolate the MIRI®Humidity multiroom IVF
incubator from the mains.
Do not defeat the safety purpose of the grounding-type plug! A grounding-type plug
has two blades and a prong, which is provided for your safety. If the provided plug does not
fit into your outlet, consult an electrician to replace the outlet.
The power requirement is 230V 50 Hz OR 115V 60Hz. The built-in power supply has a switch
mode that automatically adjusts to the correct mains power between 100V-240V AC 50-60 Hz.
Figure 10.1 Power supply
11 Gas connections
There are two gas inlets on the back of the unit. These ports are marked 2100% Inletand 2
100% Inlet
Figure 11.1 Gas inlets on the back of
MIRI®Humidity multiroom IVF incubators
CO2inlet should be connected to a 100% concentration of CO2. CO2control in the compartment is
available in the range from 2.0% to 9.9%.
The N2inlet should be connected to 100% concentration N2if low oxygen conditions are required.
The O2control in the compartments is available in the range from 5.0% to 20.0% by infusing N2.
The premixed gas inlet should be connected to the CO2inlet.

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The inlet's gas pressure should be between 0.4 –0.6 bar (5.80 –8.70 PSI) and it must
be kept stable!
Always use a high-quality pressure regulator that can be set with the required precision for both
gases.
Figure 11.2 Pressure regulator
Connect the CO2gas to the CO2inlet with a suitable silicone tube. Ensure that the tube is fastened
with a clip so that it does not accidentally loosen itself during sudden pressure fluctuation. Use the
supplied 0.2µ HEPA filter on the gas line just before the inlet on the MIRI®Humidity multiroom
IVF incubator. Notice the direction.
Connect the N2inlet to the Nitrogen Bottle in a similar way.
Figure 11.3 Gas filter
The MIRI®Humidity multiroom IVF incubators can also run-on premixed gas. It is a
more expensive option for gas consumption. It also means the user cannot adjust the CO2
and O2levels without changing the gas supply. Please read the "13 Installation with pre-
mixed gas" section below for more detailed information about using the device on pre-
mixed gas.
12 User interface
In the following chapters, the functions associated with keys and menu items are going to be ex-
plained.
User interface handles daily used functions and more advanced adjustments that might be made
to the device. The main keys and their purpose are presented in table 12.1.

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Table 12.1 The main keys and their purpose
Description
Image
Main keys
ON/OFF button
Located in the REAR of the unit
Alarm key
It mutes an audible alarm and visually indicates the alarm
condition by a flashing red circle of light. The audio alarm
will come back on after 5 min. It can be muted again.
Display panel
Shows the information on the current status of the unit.
The display consists of 7 x high brightness 16 segment
LEDs. The first one is red to indicate a user warning. The
other 6 are blue and used to display normal running con-
ditions.
Setpoint key
It is used to select items on the menu and to change their
status. It is also used to change the temperature and gas
setpoints.
Arrow keys up, down & right
It is used to navigate through the menu and to change val-
ues for temperature and gas concentrations.
12.1 Activating the heat and gas controls
Heat and gas controls are activated using the ON/OFFswitch in the rear.
Soon after system activation, the main display will alternate the reading between the following 4
parameters:
Temperature
= Temperature in °C
CO2
= CO2concentration in %
O2
Mode
= O2concentration in %
= Open/Oil Culture