Esco Medical Mini MIRI Dry User manual
Rev. 3.0
Date revised 05.06.2021
Rx only
Mini MIRI® Dry and Mini MIRI®Humidity
Multiroom IVF incubators
CE 0088
USER MANUAL
Mini MIRI® Dry and Mini MIRI® Humidity Multiroom IVF incubators User Manual
Rev. 3.0
2
Tel 215-441-9661 Fax 484-698-7757
Tel +65 6542 0833 Fax +65 6542 6920
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."
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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
proves to be defective at no charge, provided you return the product (shipping, duty,
Mini MIRI® Dry and Mini MIRI® Humidity Multiroom IVF incubators User Manual
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brokerage and taxes prepaid) to Esco Medical. Any transportation charges incurred are
the responsibility of the purchaser and are not included within this warranty. This war-
ranty extends only to the original purchaser. It does not cover damage from abuse, ne-
glect, 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 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.
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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.
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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.................................................................................18
8.1 Before installation ...........................................................................................................................18
8.2 During installation...........................................................................................................................18
8.3 Post installation................................................................................................................................19
9 Getting started...........................................................................................................................................19
10 Mains connection...................................................................................................................................20
11 Gas connections......................................................................................................................................21
12 HEPA / VOC filter (applicable only for the Mini MIRI®Dry model)...................................22
12.1 Installation of new filter capsule.............................................................................................23
13 User interface..........................................................................................................................................24
13.1 Activating the heat and gas controls......................................................................................25
13.2 System menu...................................................................................................................................25
13.3 Status..................................................................................................................................................25
13.4 Main menu...................................................................................................................................26
13.4.1 Temperature sub-menu .....................................................................................................27
13.4.2 CO2 sub-menu .........................................................................................................................28
13.4.3 O2 sub-menu............................................................................................................................29
13.4.4 UVC light sub-menu (applicable only for the Mini MIRI®model)......................31
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13.4.5 Service sub-menu..................................................................................................................32
14 Installation with premixed gas.........................................................................................................32
14.1 Installation procedure at the site............................................................................................33
14.2 User training....................................................................................................................................35
15 Alarms........................................................................................................................................................35
15.1 Temperature alarms ....................................................................................................................36
15.2 Gas level alarms .............................................................................................................................37
15.2.1 CO2alarms ...............................................................................................................................37
15.2.2 O2alarms..................................................................................................................................37
15.3 Gas pressure alarms.....................................................................................................................38
15.3.1 CO2pressure alarm ..............................................................................................................38
15.3.2 N2pressure alarm.................................................................................................................38
15.4 Multiple alarms ..............................................................................................................................39
15.5 Alarm UVC light (applicable only for the Mini MIRI®Dry model) .............................39
15.6 Loss of power alarm.....................................................................................................................39
16 Changing the set points .......................................................................................................................40
16.1 The temperature set point.........................................................................................................40
16.2 The CO2gas concentration set point......................................................................................40
16.3 The O2gas concentration set point.........................................................................................41
16.4 The culture mode ..........................................................................................................................41
17 Surface temperatures and measuring temperature.................................................................42
18 Pressure.....................................................................................................................................................44
18.1 CO2gas pressure............................................................................................................................44
18.2 N2gas pressure ..............................................................................................................................44
19 Firmware...................................................................................................................................................45
20 Safe sense function................................................................................................................................45
21 Cleaning instructions ...........................................................................................................................46
21.1 Considerations about a sterile device ...................................................................................46
21.2 Manufacturer recommended cleaning procedure............................................................46
21.3 Manufacturer recommended disinfection procedure.....................................................47
22 Heat optimization plates.....................................................................................................................47
23 Humidification ........................................................................................................................................48
23.1 Mini MIRI®Dry multiroom IVF incubator ...........................................................................48
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23.2 Mini MIRI®Humidity multiroom IVF incubator................................................................49
24 Temperature validation ......................................................................................................................49
25 Gas level validation ...............................................................................................................................50
26 Alarm switch for an external system .............................................................................................50
27 Writing area on the compartment lids..........................................................................................52
28 Maintenance ............................................................................................................................................52
29 Emergency Procedures........................................................................................................................53
30 User Troubleshooting ..........................................................................................................................55
31 Specifications...........................................................................................................................................57
32 Electromagnetic compatibility .........................................................................................................58
33 The Validation guide.............................................................................................................................61
33.1 Product release criteria ..............................................................................................................61
33.1.1 Performance............................................................................................................................61
33.1.2 Electrical safety......................................................................................................................61
33.1.3 Communication & data logging .......................................................................................61
33.1.4 Gas concentration levels and consumption................................................................61
33.1.5 Cosmetic ...................................................................................................................................62
34 Validation on-site...................................................................................................................................62
34.1 Mandatory equipment.................................................................................................................63
34.2 Recommended additional equipment...................................................................................63
35 Testing .......................................................................................................................................................63
35.1 Gas supply CO2................................................................................................................................63
35.1.1 About CO2.................................................................................................................................64
35.2 Gas supply N2..................................................................................................................................65
35.2.1 About N2...................................................................................................................................65
35.3 CO2gas pressure check ...............................................................................................................66
35.4 N2gas pressure check..................................................................................................................66
35.5 Voltage supply ................................................................................................................................66
35.6 CO2gas concentration check.....................................................................................................67
35.7 O2gas concentration check .......................................................................................................67
35.8 Temperature check: Compartment bottoms ......................................................................68
35.9 Temperature check: Compartment lids................................................................................69
35.10 6-hour stability test ...................................................................................................................69
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35.11 Cleaning..........................................................................................................................................70
35.12 Test documentation form........................................................................................................71
35.13 Recommended additional testing ........................................................................................71
35.13.1 A VOC meter (applicable only for the Mini MIRI®Dry model).........................71
35.13.2 A laser particle counter....................................................................................................71
36 Clinical use................................................................................................................................................71
36.1 Temperature check.......................................................................................................................72
36.2 CO2gas concentration check.....................................................................................................72
36.3 O2gas concentration check .......................................................................................................73
36.4 CO2gas pressure check ...............................................................................................................73
36.5 N2gas pressure check..................................................................................................................74
37 The Maintenance guide .......................................................................................................................74
37.1 VOC/HEPA filter capsule (applicable only for the Mini MIRI®model) ....................75
37.2 Humidification bottle (applicable only for the Mini MIRI®Humidity model).......76
37.3 In-line HEPA filter for CO2gas..................................................................................................76
37.4 In-line HEPA filter for N2gas ....................................................................................................77
37.5 O2sensor...........................................................................................................................................77
37.6 CO2sensor........................................................................................................................................78
37.7 UV light (applicable only for the Mini MIRI®model) ......................................................78
37.8 Cooling fan .......................................................................................................................................79
37.9 Internal gas pump (applicable only for the Mini MIRI®model) .................................80
37.10 Pump module (applicable only for the Mini MIRI®Humidity model) ...................80
37.11 Proportional valves....................................................................................................................80
37.12 Gas lines..........................................................................................................................................81
37.13 Flow sensors.................................................................................................................................81
37.14 Pressure regulators....................................................................................................................82
37.15 Internal 0.2µ filter for CO2gas...............................................................................................82
37.16 Internal 0.2µ filter for N2gas..................................................................................................83
37.17 Firmware update ........................................................................................................................83
38 The Installation guide ..........................................................................................................................83
38.1 Responsibilities..............................................................................................................................83
38.2 Before installation.........................................................................................................................84
38.3 Preparing for installation...........................................................................................................84
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38.4 Bring the following to the installation site..........................................................................85
38.5 Installation procedure at the site............................................................................................85
38.6 User training....................................................................................................................................85
38.7 After the installation ....................................................................................................................86
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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. Fail-
ure 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 sup-
port stand or base and move it on a flat surface. When necessary, move the equip-
ment 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 proce-
dures 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.
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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 pre-
mixed 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 Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubators
are CO2/O2incubators.
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 Mini MIRI®multiroom IVF incubators have 2 completely separate cul-
ture heat chambers. Each chamber has its own heated lid and warming plate for Petri
dish. Mini MIRI®Dry and Mini MIRI®Humidity capacity for 35 mm Petri dish is 16 pcs.
And for 60 mm and 4-well Petri dishes 8 pcs.
To ensure maximum performance, the system of Mini MIRI®Dry and Mini MIRI®Humid-
ity multiroom IVF incubators have 4 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 sepa-
rated with a PET layer so that the lid temperature would not affect the bottom. For vali-
dation purposes, each compartment has a PT-1000 sensor built in. The circuitry is sepa-
rated from the unit's electronics so it remains a truly separate validation system.
The Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubator needs 100% CO2
and 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.
The multiroom IVF incubator needs 100% CO2and 100% N2 or premixed gas (for in-
stance, 5% CO2; 5% O2and 90% N2) in order to be able to control CO2and O2concentra-
tions 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.
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Gas recovery time is less than 3 min. after opening the lid. To validate gas concentration,
the Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubator is fitted with 2
gas sample ports that allow the user to sample gas from the individual compartment.
The Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubator features a recir-
culated 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 Mini MIRI®Humidity multi-
room 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 Mini MIRI®Dry and Mini 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 accu-
mulated), 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 compart-
ment numbering and the ability to write on the white lid with a pen.
The Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubator has been primar-
ily 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 Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF in-
cubators is large, clear and easy to read from a distance. The user can tell if the parame-
ters are correct without going near the unit.
The Mini MIRI®Dry and Mini 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.
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The device is manufactured under a full EU certified 13485 ISO quality management sys-
tem.
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 Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incuba-
tors. Also, the Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubators do not
contain or incorporates: a medical substance, including a human blood or plasma deri-
vate; 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 Mini
MIRI®Dry and Mini MIRI®Humidity 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
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•Keep dry
5.2.2 Operation environment requirements
•Environmental temperatures below 30 °C
•Away from direct sunlight
•Kept dry
•For indoor use only
5.3 Disposal
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.
6 Supplied service parts and accessories
Service parts:
•1 VOC/HEPA filter capsule (only for Mini MIRI® Dry model)
•1 humidity bottle (only for Mini MIRI®Humidity model)
•2 HEPA filter for input gas supply
•2 warming blocks
•4 warranty labels
•1 pump box calibration tool (only for Mini MIRI®Humidity model)
•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
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Accessories do not apply with the Mini MIRI®Dry and Mini MIRI® Humidity multiroom
IVF incubators.
7 Safety symbols and labels
There are several user labels on the surfaces of Mini MIRI®Dry and Mini 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, for a variety of rea-
sons, 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 in-
formation, 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 label
Description
Image
Table 7.2 Info labels on Mini MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubators
Description
Image
USB communication port
CO2inlet
N2inlet
Alarm port
Compartments numbers are indicated in the
top corner of the lid with a label
Humidification bottle1
VOC/HEPA filter2
1Only for Mini MIRI®Humidity model
2Only for Mini MIRI®Dry model
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Compartment numbers are shown in the picture below and also indicated on the top of
the lid with labels:
Figure 7.1 Compartment numbers on Mini MIRI®Dry and Mini 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
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 elec-
trician 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.
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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 Mini
MIRI®Dry and Mini MIRI®Humidity multiroom IVF incubators contain high volt-
age components that may be hazardous.
3. Unplug this device during lightning storms or when unused for an extended pe-
riod 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 manu-
als.
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 Mini 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 Mini MIRI®Humidity multiroom IVF incubator).
9 Getting started
The Mini MIRI®Dry and Mini 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.
Mini MIRI® Dry and Mini MIRI® Humidity Multiroom IVF incubators User Manual
Rev. 3.0
20
3. Connect the mains cable to the Mini MIRI®Dry or Mini 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 Mini MIRI®Dry or Mini 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 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 success-
ful.
Clean and disinfect the device before use. It is not delivered sterile or in a clin-
ically acceptable cleanliness state. Consult the cleaning instructions section in this
manual for the manufacturer's recommended guidelines!
10 Mains connection
The Mini MIRI®Dry and Mini 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 Mini MIRI®Dry and
Mini 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
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