Esco Medical CE 0123 Скачать руководство пользователя страница 2

 

CultureCoin

®

 User Manual Rev. 7.0

 

2

 

 

 

 

    Esco Medical Technologies, UAB

 

Draugystes g. 19 • Kaunas, Lithuania

 

Tel +370 37 470 000

 

www.esco-medical.com • [email protected]

 

 

For Technical Service, contact

 

Europe

 

Esco Medical Technologies, UAB

 

Draugystes g. 19 • Kaunas, Lithuania

 

Tel +370 37 470 000

 

www.esco-medical.com • [email protected]

 

 

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 

 [email protected] 

 

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 • [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.

 

Содержание CE 0123

Страница 1: ...Rev 7 0 Date of Revised 23 11 2022 Rx only CultureCoin CE 0123 USER MANUAL...

Страница 2: ...rved 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...

Страница 3: ...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 locatio...

Страница 4: ...he 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 w...

Страница 5: ...e 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 MERCHANTABIL...

Страница 6: ...s 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 Remo...

Страница 7: ...pose 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 speci...

Страница 8: ...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 tar...

Страница 9: ...ckage 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 no...

Страница 10: ...e 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...

Страница 11: ...rview 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...

Страница 12: ...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 asept...

Страница 13: ...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 dow...

Страница 14: ...d 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 l culture medium The washing wells can also be filled but it is no...

Страница 15: ...e 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 a...

Страница 16: ...dimensions Diameter x Height 71 x 10 mm Weight empty 0 5 gram Material Polystyrene Temperature range 25 0 40 0 C CO2 range 1 9 10 0 O2 range 4 9 20 0 Sterilization method Gamma beam Lifetime 2 years T...

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