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Summary of Contents for Esco Medical CultureCoin
- Page 1 0123 USER MANUAL CultureCoin ® Rev. 9.0 Date of Revised 31.03.2023 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, UAB manufacturing specifications when shipped from the factory. Warranty and Product Support Esco Medical Technologies, UAB warrants this medical device to be free from defects in materials and workmanship under regular use and service until the date “Use by”...
- Page 4 This warranty is limited to repairing the medical device per Esco Medical Technologies, UAB specifications. When you return the medical device to Esco Medical Technologies, UAB 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, UAB 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.
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Page 6: Table Of Contents
11 Removing the CultureCoin cover ....................13 ® 12 The use illustrated ..........................14 13 pH measuring ............................15 14 Writing area on the CultureCoin and lid ..................15 ® 15 User troubleshooting..........................16 16 Specifications............................16 17 Other countries ............................17 17.1 Switzerland ............................ -
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 CultureCoin is a sterile, single-use culture vessel specifically ® developed for use in IVF. It consists of two parts: dish and cover. The dish holds up to 14 embryos in the centrally placed line of culture wells. - Page 8 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.
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Page 9: Safety Symbols And Labels
Regulation (EU) NO. 722/2012. 5 Safety symbols and labels There are several user labels on the surfaces of the CultureCoin to guide the user. User ®... -
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. Always keep these instructions in a place where they can be easily accessed. -
Page 11: Post-Use
They cannot be used for open culture. 8 Overview Figure 8.1 CultureCoin overview ® The CultureCoin dish consists of 2 parts: ® • CultureCoin dish (1). ® • Cover (2) that covers the entire CultureCoin area. ® CultureCoin User Manual Rev. 9.0 ®... -
Page 12: Use
11. Optionally fill the pH well with culture media up to the lowest step (recommended volume – 350 µl) of the pH well and cover it with an oil overlay (recommended volume – 150 µl). 12. Put on the CultureCoin cover. ®... -
Page 13: Culturecoin ® Placement In The Compartment
® Before starting the time-lapse, correctly placing the CultureCoin in the compartment is ® essential. To ensure the correct position of the CultureCoin (so that the camera can ® identify all the culture wells), place the CultureCoin in its place and secure its position ®... -
Page 14: The Use Illustrated
Figure 12.3 The culture wells are covered with a mineral or Paraffin oil layer and the cover is put on The culture media is filled into the culture wells (marked red), then oil (marked blue- green) is added to cover the entire cultivation area. CultureCoin User Manual Rev. 9.0 ®... -
Page 15: Ph Measuring
13 pH measuring Validating the pH of the culture media should be a standard procedure. The CultureCoin ® has a large well outside the culturing area (Figure 8.1). It makes it possible to make spot checks safely and conveniently on the pH level without disturbing culture wells. -
Page 16: User Troubleshooting
Use equilibrated media. Oil overflows during the Too much oil is used for oil overlay Decrease the oil volume. handling of the dish. under culture wells. 16 Specifications Table 16.1 CultureCoin specifications ® Technical specifications CultureCoin ® Overall dimensions (Diameter x Height) Ø... -
Page 17: Other Countries
In case of any serious incidents that have occurred in relation to the device should be reported to Esco Medical Technologies, UAB, by contacts, written on the contact information page, and the Authorised Representative in which the user and/or patient is established.
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