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CultureCoin

®

 User Manual Rev. 7.0

 

3

 

 

Unpacking and Inspection 

Follow  standard  receiving  practices  upon  receipt  of  the  medical  device.  Check  the 
shipping carton for damage. If the damage is found, stop unpacking the medical device. 
Notify the freight carrier and ask for an agent to be present while the medical device is 
unpacked. There are no special unpacking instructions, but be careful not to damage the 
medical device when unpacking it. Inspect the medical device for physical damage such 
as bent or broken parts, dents, or scratches. 

Claims 

Our routine method of shipment is via common carrier. If physical damage is found, upon 
delivery, retain all packing materials in their original condition and immediately contact 
the carrier to file a claim. 
If the medical device is delivered in good physical condition but does not operate within 
specifications, or if there are any other problems not caused by shipping damage, please 
contact your local sales representative or Esco Medical Technologies immediately. 

Standard Terms and Conditions 
Refunds & Credits 

Please note only sterilized products (products labeled with a distinct serial number) and 
accessories are eligible for a partial refund and/or credit. The 

Return Procedure 

must be 

followed. 

Return Procedure 

Every  product  returned  for  refund/credit  must  be  accompanied  by  a  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 location. 

Restocking Charges 

Products  returned  within  30  days  of  original  purchase  are  subject  to  a  minimum 
restocking  fee  of  20%  of  the  list price.  Additional  charges  for  damage  and/or  missing 
parts and accessories will be applied to all returns. Products that are not in 

“as

 

new”

 and 

resalable condition are not eligible for credit return and will be returned to the customer 
at their own expense. 

Certification 

This  medical  device  has  been  thoroughly  tested/inspected  and  found  to  meet  Esco 
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. Any 
transportation charges incurred are the purchaser's responsibility and are not included 
within this warranty. This warranty extends only to the original purchaser. It does not 
cover  damage  from  abuse,  neglect,  accident  or  misuse,  or  as  the  result  of  service  or 
modification by parties other than Esco Medical Technologies. 

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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