Esco Medical MIRI TL Series User manual

Rev. 1.0
Date of Revised 05.04.2021
Rx only
MIRI®TL family`s multiroom IVF
incubators
CE 0088

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
2
Tel 215-441-9661 Fax 484-698-7757
Tel +65 6542 0833 Fax +65 6542 6920
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 no-
tify any person or entity of such change.
Caution: Federal law restricts this device to sale by or on a licensed healthcare practition-
er's order.
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®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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Unpacking and Inspection
Claims
Standard Terms and Conditions
Refunds & Credits
Return
Procedure
Return Procedure
prepaid
Restocking Charges
Certification
Warranty and Product Support

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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•
•
•
•
•
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:
•
•
•

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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Re-calibration of instruments, which have a recommended annual calibration frequency,
is not covered under warranty.
Warranty Disclaimer
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all costs, 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

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Table of contents
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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. : first,
familiarize yourself with the safety instructions; then, proceed to the essential user
functions needed for operating the equipment on a day to day basis; then, review the
alarm functions. The menu function of the user interface details information that is
needed . All parts must be read before the device is taken into use.
2 Safety warning
•
•
•
•
•
•
NOTE
WARNING
•

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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3 Indication for use
Esco Medical MIRI®TL family`s multiroom IVF incubators are intended to provide an
environment with controlled temperature, CO2and other gases for the development of
embryos. This model has an integrated inverted microscope and imaging system for
embryo viewing. The device use is limited up to six days (199 hours), covering the time
from post-fertilization to day 6 of the development
4 About the product
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.
multiroom IVF incubator
They
control and regulate temperature in culture chambers and lids.

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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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®TL6 or MIRI®TL12 multiroom IVF incubator can be prepared for transport.
•Label with handling symbols and the marked packing date
•Label with the product name and serial number
•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 infor-
mation 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
•
•
•
•

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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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
Service parts:
•
•
•
•
•
•
•
•
•
Accessories:
•

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7 Safety symbols and labels
Table 7.1
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. Consult instruction for use.
2. Warning on the back of the device indicates that an
earth connection is needed and the mains information
and an "ON/OFF" push button.
3. "Lightning bolt" indicates the potential risk of
electrical shock (never remove any cover).

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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Table 7.2Device label
Description
Image
Table 7.3 Labels on the MIRI®TL6 and MIRI®TL12 multiroom IVF incubators
Description
Image
USB communication port1
USB communication port line 12
USB communication port line 22
CO2inlet
N2inlet
BNC pH
pH SAFE Sense
Alarm port
1
2

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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Compartment numbers are indicated on the
top corner of the lid with a label
Maximum pressure 0.8 bar
VOC/HEPA filter
Ethernet
TL on/off
PT 1000 validation sensors
Gas sample ports
Figure 7.1
Figure 7.2

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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8.1 Before installation
1.
2.
3.
8.2 During installation
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
8.3 Post installation
1.
2.
3.

MIRI®TL family`s multiroom IVF incubators User Manual Rev. 1.0
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4.
5.
6.
7.
8.
9.
10.
11.
12.
9 Getting started
The MIRI® TL6 and MIRI® TL12 multiroom IVF incubators must be installed by
authorized and trained personnel only!
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
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!
This manual suits for next models
2
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