Esco Medical CultureCoin CE 0123 User Manual

Esco Medical CultureCoin CE 0123 User Manual

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

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Summary of Contents for Esco Medical CultureCoin CE 0123

  • Page 1 CE 0123 USER MANUAL CultureCoin ® Rev. 7.0 Date of Revised 23.11.2022 Rx only...
  • Page 2 Esco Medical Technologies, UAB Draugystes g. 19 • Kaunas, Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com For Technical Service, contact Europe Esco Medical Technologies, UAB Draugystes g. 19 • Kaunas, Lithuania Tel +370 37 470 000 www.esco-medical.com • support-medical@escolifesciences.com North America Esco Technologies, Inc.
  • Page 3 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.
  • Page 4 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: •...
  • Page 5 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.
  • Page 6: Table Of Contents

    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 ..............................
  • Page 7: How To Use This Manual

    Preparing, storing and transferring human embryos. To be used only with the MIRI ® 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.
  • Page 8 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.
  • Page 9: Safety Symbols And Labels

    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.
  • Page 10: Important Safety Instructions And Warnings

    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.
  • Page 11: Overview

    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.
  • Page 12: Use

    The correct way to assemble the CultureCoin dish using both lids: ® Figure 8.3 Assembled 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 ®...
  • Page 13: Culturecoin ® Placement In The Compartment

    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.
  • Page 14: The Use Illustrated

    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.
  • Page 15: Ph Measuring

    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.
  • Page 16: Specifications

    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 range 1.9 – 10.0% range 4.9 – 20.0% Sterilization method Gamma beam Lifetime...

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