Esco Medical CE 0123 User Manual Download Page 9

 

 

CultureCoin

®

 User Manual Rev. 7.0

 

9

 

 

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. Model 
3. Catalogue number 
4. Batch code 
5. Temperature limit 
6. R

x

 only 

7. Consult instructions for use 
8. Do not use if package 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 not re-use 
19. Non-pyrogenic 
20. Do not resterilize 
21. WEEE

 

 

Packing box label: 

1. Logo 
2. Model 
3. Catalogue number 
4. Batch code 
5. Consult instructions for use 
6. Do not use if package is damaged 
7. Keep away from direct sunlight 
8. Manufacturer 
9. UDI code 
10. CE mark 
11. Use-by date 
12. Keep dry 
13. Temperature limit 
14. Medical device 
15. Sterilized using irradiation 
16. Amount of dishes 

 

Summary of Contents for CE 0123

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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