Esco Miri Multi-Room Incubator Version 1.1
ESCO MEDICAL Esco Micro Pte Ltd 21 Changi South Street 1 Singapore 486777 Tel. : +65 6542 0833 Fax : +65 6542 5732 / 6546 2913 Mail : csis-medical@escoglobal.com Web : www.escoglobal.com : www.medical.escoglobal.com Service address: Please contact your local distributor for details. Users of ESCO MEDICAL products should not hesitate to contact us if there are any unclear points or ambiguities in this manual. CAUTION: If the equipment is used in a manner not specified in this manual, the safety of the user may be at risk and the equipment may be damaged. Always use the equipment as outlined in this instruction manual. COPYRIGHT This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, otherwise copied or distributed, completely or in part, without the approval of ESCO MEDICAL. 2
Table of Contents 1 Welcome... 4 2 Reading Instructions for the Text.... 5 3 Explanation of Symbols Used... 5 4 About the Product... 6 5 Manuals Supplied... 7 5.1 The User Manual... 7 5.2 The Validation Manual... 7 5.3 The Maintenance Manual... 7 6 Installation... 8 6.1 Responsibilities... 8 6.2 Before Installation... 8 6.3 Preparing Installation... 9 6.4 Bring To the Installation Site... 9 6.5 Installation Procedure at the Site... 10 6.6 User Training... 10 6.7 After the Installation... 11 7 Technical Assistance... 12 3
1 Welcome Congratulations with the acquisition of your MRI-6A10/XQ-1 incubator. We at ESCO MEDICAL are proud that you have chosen our product to serve your needs. We hope to hear from you with feedback on this product that can benefit future product developments. We will strive to serve you well. Thank you. 4
2 Reading Instructions for the Text The installation procedures is detailed in Chapter 5 and forwards. Chapters from 2 5 can be skipped if prior knowledge about the product exist. Chapters 5 and forward must be read chronologically. 3 Explanation of Symbols Used NOTE Used to direct attention to a specific item. DANGER Used when caution is needed. 5
4 About the Product The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts. Direct warming of the dishes in the chambers gives superior temperature conditions in comparison to conventional incubators. The MRI-6A10/XQ-1 incubator has 6 completely separate culture heat chambers each having its own heated bottom, heated lid and a heating optimization plate. The heating optimization plates are customized to accommodate several types of dishes for either Falcon or Nunc. For maximum performance the system has 12 separate temperature controllers, controlling and regulating the temperature in the culture chambers and the lids. The Incubator needs 100% CO2 and 100% N2 in order to be able to control the CO2 and O2 concentrations in the culture chambers. The incubator has been primarily developed and optimized for tissue culturing with an overlay of either Paraffin or Mineral oil. If open culture is used the user must switch the device to open culture mode. Open culture may lead to evaporation and a change in ph. If the correct conditions are not maintained. The incubator can be connected to a pc running the ESCO MEDICAL data logging software for long term data logging and data storage. The device is manufactured under a full EU certified ISO quality management system. This product fulfils the requirements of EN60601-1 3 rd edition standards as a Class I type B equivalent device suited for continuous operation. It also conform to the requirements of the EU Council directive 93/42/EEC concerning medical devices and is classified as a Class IIa device under rule II. 6
5 Manuals Supplied The MRI-6A10/XQ-1 incubator comes with 3 manuals as standard. The User Manual The Validation Manual The Maintenance Manual Each manual has a specific purpose. 5.1 The User Manual Is intended to provide the user with the information that is necessary for using the device. The user manual cannot stand alone or replace user training. 5.2 The Validation Manual Is intended to provide the trained technical personnel that is performing the installation, the procedures and specifications, for making sure the device is safe, so that it can be taken into clinical use. The manual also includes a guide for the validation tests that should be performed regularly. 5.3 The Maintenance Manual Is intended to provide the schedules and the methods for the trained technical personnel that ensures that the device is running optimally and safely during its entire lifespan. The maintenance specified in the maintenance manual cannot replace the regular validation that user must perform. 7
6 Installation This document describes when and how to install an MRI-6A10/XQ-1 Incubator at an IVF clinic. 6.1 Responsibilities All technicians or embryologists installing the MRI-6A10/XQ-1 incubator must be able to identify problems, and perform any necessary calibrations, adjustments and maintenance. Installation personnel performing MEA (Mouse Embryo Assay) must be thoroughly familiar with the MEA and all functions of the instrument, calibration and testing procedures as well as any instruments used in the testing of the instrument. A MEA test is a supplemental installation test and is not mandatory. All individuals who will perform Installation, repair and/or maintenance of the instrument must be trained by AT Medical or at a qualified training center. Training is conducted by experienced service technicians or embryologist to ensure that the installation personnel have a clear understanding of the function, performance, testing and maintenance of the instrument. Installation personnel must be updated as regards to alterations or additions to this document and the Installation test form that can be found in the validation manual in section 8.13. 6.2 Before Installation 2-3 weeks before the Installation time is up, the user/owner at the Clinic is contacted via e-mail, to plan the exact time to perform the installation. When a convenient time has been found travel and accommodation arrangements can be done. The released MRI-6A10/XQ-1 incubator must be sent 1-3 weeks before installation depending on the clinic location. Check with shippers about local customs regulations and delays that could arise from that. The Clinic must be informed about the site requirements before installation and have signed the customer requirement check list: The lab must have an idle sturdy and stable lab bench for standing operation. The MRI-6A10/XQ-1 weight is app. 30 kg and space required 1.0 m x 0.6 m Temperature control should be able to maintain stable temperature it must never exceed more than 30 C 8
Humidity control to avoid condensation Uninterrupted power supply (UPS) with 115 or 230 V minimum 120 W Proper grounding and HFI relay CO2 gas outlet with 0.6-1.0 atm above ambient N2 gas outlet with 0.6-1.0 atm above ambient if the clinic uses reduced oxygen levels Tubes that fit 4 mm hose nipple and HEPA filter Access to a PC with USB for the data logging 6.3 Preparing Installation Print out the form: Installation test from the validation manual. Make sure it is the latest and current version only. Fill out the following blank boxes in the form: MRI-6A10/XQ-1 S/N and Customer. A service tool kit is checked for content before every installation trip to assure it contains the needed tools. Always bring the latest versions of Firmware and the Data logging SW. Bring these files on a memory stick with label to the service site. 6.4 Bring to the Installation Site Installation test form. Service Manual for the MRI-6A10/XQ-1. Updated Service tool kit. Memory stick with the latest released FW & SW. YSI 4610 high precision thermometer and corresponding YSI probe 4611. InControl 1050 gas analyser and/or Galaxy/Geotech gas analyser. Extension cable for USB connection. 9
6.5 Installation Procedure at the Site 1. Follow the guidelines in the safety instructions and warnings section of the user manual. 2. Connect the mains cable to the UPS 3. Connect the mains cable to the MRI-6A10/XQ-1 Incubator 4. Connect and secure the gas lines. 5. Set the gas pressure on the external gas regulator at 0.6 Bar. 6. Switch on the MRI-6A10/XQ-1 on the back. 7. Observe for normal functionality. 8. Let the unit warm up and stabilize for 20 min. 9. Follow the guidelines in the Validation Guide. 10. Complete user training and instructions outlined in section 5.6 11. After a burn in phase of 24 hours the unit is ready for use IF the testing is successful. If there are any deviations these must be discussed with the user or owner of the MRI-6A10/XQ-1. If there are any suggestions or complaints, these must also be recorded in the installation test form. 6.6 User Training Mains switch ON/OFF Explain basic function of MRI-6A10/XQ-1. Incubation with multi room facility for storing the samples. Explain temperature control in MRI-6A10/XQ-1 (Direct heat transfer with heated lids) Gas regulation on/off Set point for temperature, CO2 and O2. Explain how N2 is used to suppress the O2 level. Alarm turn off procedure (temperature, CO2, O2) and revert times. Insertion and removal of heating inserts. How to toggle the under oil and open culture modes and when what mode should be used. Emergency procedures (can be found in the user manual). How to clean device and heating inserts. External measurement and calibration of temperature (YSI probe) External measurement and calibration of gas concentration. (InControl or Galaxy). Add a sample and remove a sample. Data logger functionality and how the connection and re-establish connection works. 10
Use the user manual as much as possible to get the user well acquainted with it. The User/owner is informed that the first VOC filter change is 3 months after installation and then with 3 months intervals. First service check is under normal circumstances after 1 year. 6.7 After the Installation When the installation trip is finished a copy of the original Installation test form must be sent to AT Medical Ltd. It will be saved with the device records. A paper copy of the completed and signed Installation test form is stored in the device history record of the unique device according to the ISO procedure and Medical Device Directive. The date of Installation is written in the Instrument Overview file. The date of Installation is also written in the Service schedule. If the MRI-6A10/XQ-1 user or owner make inquiries about a written Installation report the completed and signed Installation test form must be sent to the clinic. Any deviations/complains/suggestions from the Installation visit are reported in the CAPA system. If a critical error has occurred information about this is to be reported directly to QC or QA. If the MRI-6A10/XQ-1 fail any of the Installation test accept criteria or it in any way suffer from a severe error and incubation parameters is compromised the MRI-6A10/XQ-1 must be taken out of service until the MRI-6A10/XQ-1 is repaired/ exchanged or new test approves the MRI-6A10/XQ-1. The MRI- 6A10/XQ-1 user and owner must be informed about this and arrangements to solve the problems must be initiated. 11
7 Technical Assistance For more information, contact ESCO MEDICAL or the representative in your Country. All goods and services are sold subject to the terms and conditions of sale of the company within ESCO MEDICAL which supplies them. A copy of these terms and conditions is available only on request. Contact your local ESCO MEDICAL representative for the most current information. 2012 ESCO MEDICAL All rights reserved. ESCO MEDICAL Esco Micro Pte Ltd 21 Changi South Street 1 Singapore 486777 Tel. : +65 6542 0833 Fax : +65 6542 5732 / 6546 2913 Mail : csis-medical@escoglobal.com Web : www.escoglobal.com : www.medical.escoglobal.com 12