Esco Medical CE 0123 Скачать руководство пользователя страница 7

 

 

CultureCoin

®

 User Manual Rev. 7.0

 

7

 

 

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 

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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