Esco Medical CE 0123 User manual

Rev. 7.0
Date of Revised 23.11.2022
Rx only
CultureCoin®
CE 0123
USER MANUAL

CultureCoin®User Manual Rev. 7.0
2
Esco Medical Technologies, UAB
Draugystes g. 19 • Kaunas, Lithuania
Tel [phone]
www.esco-medical.com • support[email protected]
For Technical Service, contact
Europe
Esco Medical Technologies, UAB
Draugystes g. 19 • Kaunas, Lithuania
Tel [phone]
www.esco-medical.com • support[email protected]
North America
Esco Technologies, Inc.
903 Sheehy Drive, Suite F, Horsham, PA 19044, USA
Tel [phone] •Fax [phone]
www.escolifesciences.us •[email protected]
Rest of the World
Esco Micro Pte. Ltd.
21 Changi South Street 1 • Singapore 486 777
Tel [phone] •Fax [phone]
www.escolifesciences.com • [email protected]
Copyright Information
© Copyright 2014 Esco Micro Pte Ltd. All rights reserved.
The information in this manual and the accompanying product is copyrighted and all rights are
reserved by Esco.
Esco reserves the right to make periodic minor design changes without obligation to notify any
person or entity of such change.
Sentinel™ is a registered trademark of Esco.
Caution: Federal law restricts this device to sale by or on a licensed healthcare practitioner's order.
Only to be used by a trained and qualified professional. The device is sold under exemption 21 CFR
801 Subpart D.
"Material in this manual is provided for informational purposes only. The contents and the product
described in this manual (including any appendix, addendum, attachment or inclusion) are subject to
change without notice. Esco makes no representations or warranties as to the accuracy of the
information contained in this manual. In no event shall Esco be held liable for any damages, direct or
consequential, arising out of or related to the use of this manual.

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Unpacking and Inspection
Follow standard receiving practices upon receipt of the medical device. Check the
shipping carton for damage. If the damage is found, stop unpacking the medical device.
Notify the freight carrier and ask for an agent to be present while the medical device is
unpacked. There are no special unpacking instructions, but be careful not to damage the
medical device when unpacking it. Inspect the medical device 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 medical device is delivered in good physical condition but does not operate within
specifications, or if there are any other problems not caused by shipping damage, please
contact your local sales representative or Esco Medical Technologies immediately.
Standard Terms and Conditions
Refunds & Credits
Please note only sterilized products (products labeled with a distinct serial number) and
accessories are eligible for a partial refund and/or credit. The Return Procedure must be
followed.
Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material
Authorization (RMA) number, obtained from Esco Medical Technologies Customer
Service. All items being returned must be sent prepaid (freight, duty, brokerage and
taxes) to our factory location.
Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum
restocking fee of 20% of the list price. Additional charges for damage and/or missing
parts and accessories will be applied to all returns. Products that are not in “as new” and
resalable condition are not eligible for credit return and will be returned to the customer
at their own expense.
Certification
This medical device has been thoroughly tested/inspected and found to meet Esco
Medical Technologies´ manufacturing specifications when shipped from the factory.
Warranty and Product Support
Esco Medical Technologies warrants this medical device to be free from defects in
materials and workmanship under regular use and service until the date “Use by”
provided on the label. During the warranty period, Esco Medical Technologies will
replace a product that proves to be defective at no charge, provided you return the
product (shipping, duty, brokerage and taxes prepaid) to Esco Medical Technologies. Any
transportation charges incurred are the purchaser's responsibility and are not included
within this warranty. This warranty extends only to the original purchaser. It does not
cover damage from abuse, neglect, accident or misuse, or as the result of service or
modification by parties other than Esco Medical Technologies.

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IN NO EVENT SHALL ESCO MEDICAL TECHNOLOGIES, UAB BE LIABLE FOR
CONSEQUENTIAL DAMAGES.
No warranty shall apply when any of the following causes damage:
•Damage in transit or when moving the medical device
•Accident, alteration, abuse or misuse of the medical device
•Fire, water damage, theft, war, riot, hostility, acts of God such as hurricanes, floods,
etc.
Only CultureCoin®is covered under this warranty if the package is not damaged during
storage and transportation.
PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER
THE 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 medical device per Esco Medical Technologies specifications.
When you return the medical device to Esco Medical Technologies for investigation, we
recommend shipment using the original shipping foam and container. If the original
packing materials are not available, we recommend the following guide for repackaging:
•Use a double-walled carton of sufficient strength for the weight being shipped.
There cannot be spare space in the shipment box with the medical device;
otherwise, it will move and can cause possible damage
•In the case of a single medical device is sent, an envelope with an adapted bubble
envelope may be used
Esco Medical Technologies will not be responsible for lost shipments or medical devices
received in damaged condition due to improper packaging or handling. All warranty
claim shipments must be made on a prepaid basis (freight, duty, brokerage, and taxes).
No returns will be accepted without a Return Materials Authorization ("RMA”) number.
Please contact Esco Medical Technologies to obtain an RMA number and receive help
with shipping/customs documentation.
Warranty Disclaimer
With CultureCoin®dishes could work only individuals with formal education in a relevant
field of healthcare or medical discipline. If this medical device is used by other person,
Esco Medical Technologies, UAB takes no responsibility for damage to users, patients and
property.
If a primary package of CultureCoin®is damaged before opening it, Esco Medical
Technologies, UAB takes no responsibility for damage to users, patients and property.

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WARNING
Esco Medical Technologies will not be responsible for any possible injury and side effects
sustained due to unauthorized equipment modifications.
ESCO MEDICAL TECHNOLOGIES, UAB 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.

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Table of contents
1 How to use this manual............................................................................................................................ 7
2 Safety warning............................................................................................................................................. 7
3 Intended purpose....................................................................................................................................... 7
4 About the product ...................................................................................................................................... 7
5 Safety symbols and labels ....................................................................................................................... 9
6 Important safety instructions and warnings.................................................................................10
6.1 Pre-use .................................................................................................................................................10
6.2 During use...........................................................................................................................................10
6.3 Post use................................................................................................................................................10
7 The Culture mode.....................................................................................................................................10
8 Overview......................................................................................................................................................11
9 Use..................................................................................................................................................................12
10 CultureCoin®placement in the compartment............................................................................13
11 Removing the CultureCoin®lid ........................................................................................................13
12 The use illustrated.................................................................................................................................14
13 pH measuring..........................................................................................................................................15
14 Writing area on the CultureCoin®and lid....................................................................................15
15 User troubleshooting............................................................................................................................15
16 Specifications...........................................................................................................................................16

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1 How to use this manual
The manual is intended to be read from start to finish.
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 operating personnel,
and/or poor equipment performance.
•The use of any hazardous materials in this equipment must be monitored by an
industrial hygienist, safety officer or other suitably qualified individuals.
•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 Intended purpose
Preparing, storing and transferring human embryos. To be used only with the MIRI®TL
device.
4 About the product
The Esco Medical Technologies CultureCoin®is a sterile, single-use culture vessel
specifically developed for use in IVF. The dish holds up to 14 embryos in the centrally
placed line of culture wells. The culture well features a 300 µm, optically clear area where
the embryo is situated. The area is optimized for microscopy. A clear circle is present
around the culture area for the purpose of making it easy for an automatic focus
algorithm to find the area under microscopic image acquisition. The culture wells are
numbered (1 –14) for easy location of each well by the user. Each culture well has two
washing wells for cell manipulations, washing media or replacement media.
The lid is mounted inside the circumference of the dish covering the culture area
completely –the user will only grab the dish during handling and not risk losing the dish
by holding on to the lid only –as can be the case on all traditionally designed dishes. A

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large well is provided outside the culture for pH measuring without affecting the cultured
samples. The dish has a flat bottom, so it is ideal for heat transfer from below.
Principles of operation of the device and its mode of action: CultureCoin®is designed to
culture cells only in Esco Medical Technologies MIRI®TL family’s multiroom IVF
incubators for a period of up to 6 days. The capacity of droplets in incubation wells is
25μl. Such an amount of media is sufficient for cell development during such a period. A
high wall surrounds the droplet area to ensure enough space for an oil overlay to secure
media from evaporation. Incubation wells are situated in one line, at the same height and
across the exact distance between well centers. It perfectly fits the design of the MIRI®
TL family’s multiroom IVF incubators, which camera moves under CultureCoin®along
incubation wells.
Model Code: MRI-CC.
With CultureCoin®dishes could work only individuals with formal education in a relevant
field of healthcare or medical discipline.
The CultureCoin®'s intended target groups are IVF patients. Patients are women in their
reproductive years who have fertility health issues. The intended target group indication
is IVF treatment. There are no intended target group contraindications.
CultureCoin®is a medical device intended for use on one patient during a single
procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used
on another patient.
CultureCoin®can be used only with the MIRI®TL family’s multiroom IVF incubators and
sequential media specifically designed for IVF treatment. CultureCoin® cannot be used
with non-medical devices and other non-IVF treatment-designed media.
The device is manufactured under a full EU certified 13485 ISO quality management
system.
This product 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 CultureCoin®. Also, the CultureCoin®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.

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5 Safety symbols and labels
There are several user labels on the surfaces of the CultureCoin®to guide the user. User
labels are shown below.
Table 5.1 Packing bag and box labels
Description
Image
Packaging bag label:
1. Logo
2. Model
3. Catalogue number
4. Batch code
5. Temperature limit
6. Rxonly
7. Consult instructions for use
8. Do not use if package is damaged
9. Keep away from direct sunlight
10. Manufacturer
11. UDI code
12. CE mark
13. Use-by date
14. Sterilized using irradiation
15. Sterile barrier system
16. Keep dry
17. Medical device
18. Do not re-use
19. Non-pyrogenic
20. Do not resterilize
21. WEEE
Packing box label:
1. Logo
2. Model
3. Catalogue number
4. Batch code
5. Consult instructions for use
6. Do not use if package is damaged
7. Keep away from direct sunlight
8. Manufacturer
9. UDI code
10. CE mark
11. Use-by date
12. Keep dry
13. Temperature limit
14. Medical device
15. Sterilized using irradiation
16. Amount of dishes

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6 Important safety instructions and warnings
6.1 Pre-use
1. Do not use the product if the package is damaged. Contact Esco Medical
Technologies or the local representative.
2. Read the user manual thoroughly before use.
3. Always keep these instructions at hand.
With CultureCoin®dishes could work only individuals with formal education
in a relevant field of healthcare or medical discipline.
Basic training on how to use CultureCoin®with MIRI®TL family’s multiroom IVF
incubators is provided along with the installation of MIRI®TL family’s multiroom IVF
incubators.
6.2 During use
1. Use only for the purpose listed under intended use.
2. The dishes are single-use only. Please do not attempt to clean and reuse them.
3. Only for the use of water-based culture media and mineral oil.
4. Do not use this product at temperatures exceeding 40 °C.
Functions related to SAFETY:
•Identifying the correct dish
•Avoiding cross-contamination
•Placing the embryo correctly
Please refer to sections 9 –14 in this manual for more information on how to
properly use CultureCoin®.
6.3 Post use
If the dish was used to store/incubate biological samples, it should be discarded as
biohazardous waste according to laws and procedures valid in the user’s country.
7 The Culture mode
The CultureCoin®can be used only for culturing with culture media filled into the wells
and oil overlay. They cannot be used for open culture.

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8 Overview
Figure 8.1 CultureCoin®
The CultureCoin®dish consists of 3 parts:
•CultureCoin®dish (1).
•Lid (2) that covers the entire CultureCoin®area.
•A small lid (3) that covers only the middle part of the CultureCoin®area.
Figure 8.2CultureCoin®dish parts

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The correct way to assemble the CultureCoin®dish using both lids:
Figure 8.3Assembled CultureCoin®dish
The smaller lid is put on the CultureCoin®dish facing the 4 handles up. If the
lid is put upside down, it will be loose and not fit correctly.
The lid (2) is used to protect liquid content until the CultureCoin®dish is placed in MIRI®
TL multiroom IVF incubator. Before putting CultureCoin®into MIRI®TL multiroom IVF
incubator, this lid should be removed.
The small lid (3) can optionally be used to maintain stable conditions if the CultureCoin®
dish is removed from the MIRI®TL family’s multiroom IVF incubator several times during
the incubation cycle.
The small lid (3) is not used if the CultureCoin®dish is not removed from the MIRI®TL
family’s multiroom IVF incubator during the entire incubation cycle.
9 Use
1. Unpack both the lid and dish in an aseptic environment.
2. Leave the dishes with the lids on for off-gassing in the aseptic environment for 12
hours.
3. Warm the dishes on a heated stage or an incubator before filling them with media.
4. Fill all the wells with the app. 25 µl of precultured equilibrated culture media in
an aseptic environment. Filling of the washing wells is optional. They can contain
approximately 23 µl each.
5. Check under a microscope for any visible air bubbles and remove them with a
stripper tip.
6. Fill the oil area with a confluent layer of suitable mineral or paraffin oil to cover
the culture media. Do not overfill.
7. Put the lid on the dish and leave it for 4 hours of equilibration in the CO2incubator.

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8. Check for air bubbles in the culture wells after the equilibration. Remove any
bubbles with a stripper tip.
9. Load the embryos in the wells. Make sure the embryos are located very precisely
in the center of the culturing well and not on the side slope.
10. Optionally fill the pH reservoir and insert the silicone plug.
11. Incubate the CultureCoin®in the MIRI®TL.
10 CultureCoin®placement in the compartment
Before starting the time-lapse, it is essential to place the CultureCoin®in the
compartment properly. To ensure the correct position of the CultureCoin®(so that the
camera can identify all the wells), place the CultureCoin®in its place and secure its
position by pushing it downwards and towards you, then to the left edge.
Figure 10.1 Positioning CultureCoin®in the compartment
11 Removing the CultureCoin®lid
CultureCoin®lid does not have a lot of free movement on the dish while it is closed, but
the lid may move slightly during transportation. The lid can rotate a bit on the
CultureCoin®and get stuck on the dish edges. As a result, it may be harder to open it.
In such a case, there is a specific technique for the CultureCoin®lid opening. Hold the dish
and lift the lid from the cut edge.

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Figure 11.1 CultureCoin®lid opening
Please do not twist the lid of the CultureCoin®, because it will be locked, and it
will be even harder to open it.
12 The use illustrated
Figure 12.1 The wells
Each of the 14 wells is filled with approximately 25 µl culture medium. The washing wells
can also be filled, but it is not a requirement. The embryo is placed at the bottom of the
culturing area.
Figure 12.2 Embryo Placement in detail on the 300µm optically clear area

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Figure 12.3 The culture wells are covered with a mineral oil layer and the lid is put on
13 pH measuring
Validating the pH of the culture media should be a standard procedure. The CultureCoin®
is equipped with a reservoir that is located outside the culturing area. It makes it possible
to safely and conveniently make spot checks on the pH level.
Remove the silicone plug and measure with a calibrated pH probe in the reservoir. Adjust
the CO2level if necessary.
When choosing an electrode (probe), it is necessary to consider the probe's size, as
measurements will be made on either a 4-well dish or a droplet.
14 Writing area on the CultureCoin®and lid
Figure 14.1 Always mark both the lid and the dish
15 User troubleshooting
Table 15.1 Heating system
Symptom
Cause
Action
Embryos drift to the side of
the well.
The placement of the embryo is not
done with enough accuracy.
Practice correct placement.
Air bubbles appear during
culturing.
Temperature differences during
loading or incorrect procedure for
bubble removal.
Avoid temperature differences
and follow the correct
procedure. Practice proper
bubble removal.
Oil overflows during the
handling of the dish.
Too much oil in the reservoir.
Decrease the oil volume.

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16 Specifications
Table 16.1 CultureCoin®specifications
Technical specifications
CultureCoin®
Overall dimensions (Diameter x Height)
Ø 71 x 10 mm
Weight empty
0.5 gram
Material
Polystyrene
Temperature range
25.0 –40.0 °C
CO2range
1.9 –10.0%
O2range
4.9 –20.0%
Sterilization method
Gamma beam
Lifetime
2 years
Toxicity tested
Embryotoxicity tested with thawed 1 cell mouse embryos.
Expanded Blastocyst rate after 96 hours > 80 % (n=150), 0.6
bar (8.70 PSI)