ESCO MEDICAL CE 0088 CultureCoin Embryo Culture Dish User Manual

ESCO MEDICAL CE 0088 CultureCoin Embryo Culture Dish

Esco Medical Technologies, Ltd.
Draugystės street 19 • Kaunas, Lithuania
Tel +370 37 470 000
medical.escoglobal.com
support-medical@escoglobal.com

For Technical Service, contact
North America
Esco Technologies, Inc.
903 Sheehy Drive, Suite F, Horsham, PA 19044, USA
Tel 215-441-9661 • Fax 484-698-7757
www.escolifesciences.us
eti.admin@escoglobal.com

Rest of the World
Esco Micro Pte. Ltd.
21 Changi South Street 1 • Singapore 486 777
Tel +65 6542 0833 • Fax +65 6542 6920
www.escolifesciences.com
mail@escolifesciences.com

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 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.  Sentinel™ is a registered trademark of Esco.
Caution: Federal law restricts this device to sale by or on a licensed healthcare practi-tioner’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 inclu-sion) 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.”

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 contact your local sales representative or Esco Medical immediately.

Standard Terms and Condition Refunds & Credits
Please note only serialized products (products labeled with a distinct serial number) and accessories are eligible for a partial refund and/or credit. Non- serialized parts and accessory items (cables, carrying cases, auxiliary modules, etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been  damaged. It must be returned complete (meaning all manuals, cables, accessories, etc.) within 30 days of original purchase, in “as new” and resalable condition. The Return Procedure must be followed.

Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material 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. The provided instrument is calibrated and maintained following this manual. During the warranty 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, brokerage and taxes prepaid) to Esco Medical. Any transportation charges incurred are the purchaser’s responsibility and are not included within this warranty. This warranty extends only to the original purchaser. It does not cover damage from abuse, neglect, accident or misuse, or as the result of  service or modification by parties other than Esco Medical.
IN NO EVENT SHALL ESCO MEDICAL LTD. BE LIABLE FOR CONSEQUENTIAL DAMAGES. No warranty shall apply when any of the following causes damage:

• Power failure, surges, or spikes
• Damage in transit or when moving the instrument
• An improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses
• Accident, alteration, abuse or misuse of the instrument
• Fire, water damage, theft, war, riot, hostility, acts of God such as hurricanes, floods, etc.

Only serialized products (those items bearing a distinct serial number tag) and their 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 damaged condition due to improper packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and taxes). No returns will be accepted without a Return Materials Authorization (“RMA”) number. Please contact Esco Medical to obtain an RMA number and receive help with shipping/customs documentation  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. It would be best if you broke this seal only after you have received factory authorization. Please 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.

How to use this manual

The manual is intended to be read from start to finish.

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 re-sult in damage to the unit, injury to operating personnel, and/or poor equipment per-formance.

• Any internal adjustment, modification or maintenance to this equipment must be un-dertaken by qualified service personnel.

• If the equipment must be relocated, make sure it is appropriately fixed on a support stand or base, and move 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 in-dustrial hygienist, safety officer or other suitably qualified individuals.

• Before you proceed, you should thoroughly understand the installation procedures and take note of 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.

Indication for use

Preparing, storing and transferring human embryos. To be used only with the MIRI® TL device.

About the product

The Esco Medical 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 300µ, 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 re-placement 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 large well is pro-vided outside the culture are for pH measuring without affecting the cultured samples. The dish has a flat bottom, so it is ideal for heat transfer from below.

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 Labels

Important safety instructions and warnings

Pre-use

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 at hand.

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.

Post use
Discard the dishes according to the proper procedures.

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.

Overview

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 ap-proximately 23 µl each.
5. Check under a microscope for any visible air bubbles and remove them with a strip-per 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 CO2 incubator.
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.

The use illustrated

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.

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 CO2 level 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.

Writing area on the CultureCoin® and lid

User troubleshooting

Heating system

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 cul- turing.| Temperature differences during load- ing or incorrect procedure for bubble

removal.

| Avoid temperature differences and follow the correct procedure.

Practice proper bubble removal.

Oil overflows during handling of the dish.| Too much oil in the reservoir.| Decrease the oil volume.

Specifications

CultureCoin® specifications

panded Blastocyst rate after 96 hours > 80 % (n=150), 0.6 bar

(8.70 PSI)

References

• In Vitro Fertilization (IVF) Equipment Manufacturer | Esco Medical
• Esco Lifesciences | Life Science Tool Manufacturer & Service Provider
• escolifesciences.us

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