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CryopAL GT Series User Manual
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CryopAL GT Series User Manual

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Summary of Contents for CryopAL GT Series

  • Page 1 User manual www.cryopal.com...
  • Page 2 Date of obtaining CE marking: 07/07/2005 Notified body: LNE GMED All rights reserved. This document may not be reproduced in any form whatsoever, in whole or in part, without written permission from Cryopal. This manual complies with European Directive 93/42/EC concerning medical devices. Cryopal...
  • Page 3 Table of contents Table of contents G T – U s e r m a n u a l...
  • Page 4 G T – U s e r m a n u a l...

  • Page 5: Identity Of Manufacturer

    1. Identity of manufacturer The manufacturer of the GT medical device is Cryopal: Cryopal Parc Gustave Eiffel 8 Avenue Gutenberg CS 10172 Bussy Saint Georges F - 77607 Marne la Vallée Cedex 3 Phone: +33 (0)1 64 76 15 00...

  • Page 6: Safety Information

    Important / User information ** When storing biological samples classified as sensitive by the user, Cryopal recommends using the GT product range equipped with the temperature and liquid nitrogen level monitoring system called Cryomemo, with the alarm transferred to a remote video surveillance central device.
  • Page 7 2.2. General precautions for use General precautions for use Wear personal protective equipment (PPE) when handl Wear personal protective equipment (PPE) when handling the device: Protective cryogenic gloves are compulsory cryogenic gloves are compulsory Fire-resistant protective overalls (long sleeves) are re resistant protective overalls (long sleeves) are recommended commended Protective goggles are compulsory...
  • Page 8 To avoid burns, it is recommended to never touch the cold parts of the equipment (neck, cap, tube, etc.), to prevent liquid spills by always keeping the device in an upright position, and to always wear the personal protective equipment listed in the safety instructions.
  • Page 9 a display located outside the room, and the user must be equipped with a portable oxygen monitoring system. The necessary safety conditions and the provision of safety systems for operating a cryogenic room are the responsibility of the operator. 2.3. Precautions in the event of operating faults Full safety cannot be guaranteed in the following cases: The container is visibly damaged.
  • Page 10 Labels found on the GT device 2.5. Key to symbols Important: Low Important: Low Manufacturer Manufacturer temperature temperature Refer to the instruction Refer to the instruction Gloves must be worn Gloves must be worn manual Goggles must be worn Goggles must be worn Ventilate the room Ventilate the room Product reference code...
  • Page 11 CE marking, complies with CE marking, complies with Serial number Serial number Directive 93/42/EC Directive 93/42/EC Capacity in litres Capacity in litres Date of manufacture Date of manufacture 11 | G T – U s e r m a n u a l U s e r m a n u a l...
  • Page 12 3. GT device 3.1. Device overview The devices in the GT product range are unpressurised cryogenic tanks use product range are unpressurised cryogenic tanks use product range are unpressurised cryogenic tanks used to store and preserve biological specimens that have been previo preserve biological specimens that have been previously frozen in liquid nitrogen at usly frozen in liquid nitrogen at -196°C (liquid nitrogen is a cryogenic fluid).
  • Page 13 The devices must only be used for storing products in liquid nitrogen, and not for freezing. Any other gas is prohibited. Cryopal recommends you always use the T° TRACKER temperature monitoring and recording device with each cryogenic container in the GT range.
  • Page 14 3.2. Technical specifications 3.2.1. GT 2, 3, 9, 11, 21 and 35 - Long holding time Manufacturers - Cryopal - GT long holding time series Series Name GT11 GT21 GT35 Storing and preserving vials, straws, bags containing blood/living cells Purpose...
  • Page 15 3.2.2. GT 14, 26, 38 and 40 - Large capacity Tanks Cryopal - Large capacity series Name GT14 GT26 GT38 GT40 Storing and preserving vials, straws, bags containing blood/living Purpose cells Do not use outside of the temperature/humidity ranges stated in...
  • Page 16 3.3. Overview of the product range References Product description GT2-1 GT2 with 3 plastic canisters GT3-1 GT3 with 6 canisters and 1 plastic level GT9-1 GT9 with 6 canisters and 1 plastic level GT11-1 GT11 with 6 canisters and 1 plastic level GT11-4 GT11 with 6 canisters and 2 plastic levels GT21-1...

  • Page 17: Usage Instructions

    4. Usage instructions 4.1. Intended use Tanks in the GT range are designed for use in laboratories or hospital settings for the preservation and storage of biological samples. Samples could be cord blood, cells... 4.2. Expected performance The expected performance of this device is that it maintains a cryogenic temperature for preserving biological samples.
  • Page 18 4.5.2. Device There are two major adverse effects linked to the use of liquid nitrogen: 1. Deterioration of the cap: Wear and tear to the foam of the cap, linked to friction during repeated opening and closing of the cap, or loosening of the cap foam. It is recommended you have a back-up cap to use as a replacement upon the first signs of wear and tear.

  • Page 19: Materials Used

    5. Materials used Materials in direct Aluminium alloy, epoxy fibreglass composite, polycarbonate, or indirect contact Klegecell (PVC), stainless steel, and expanded polystyrene for the with the user GT40 cap. 19 | G T – U s e r m a n u a l...

  • Page 20: Storage And Handling Conditions

    6. Storage and handling conditions There are several conditions and safeguards to follow so that GT devices can be used in complete safety. 6.1. Storage The premises in which the equipment is stored must be equipped with personal protective equipment (PPE). There must be minimum safety distance of 0.5 m around the device.
  • Page 21 Relative humidity: 30% to 65% without condensation Avoid impact and sudden movements. Samples (tubes, bags, cases, etc.) must be protected before being placed in the device. This list is not exhaustive. 21 | G T – U s e r m a n u a l...

  • Page 22: Moving The Device

    7. Moving the device The device may be handled by forklift, in accordance with trade practices, only when it is within its packaging. Never use a forklift truck to handle the device when it is not in its packaging, always move it Carrying it by its handles Rolling it on its roller base.
  • Page 23 We recommend that at least one person should be present at all times to monitor filling until completion. In order to avoid the risk of splashes when filling the device, Cryopal recommends the use of a transfer pipe with anti-splash nozzle (see section 11), except for the GT2.
  • Page 24 8.2. Nitrogen level check To check the level of liquid nitrogen remaining, follow the procedure below: Remove the cap Push the plastic level gauge down to the bottom for 3 or 4 seconds (be careful of any protrusions caused by the canister distributor) Remove it and shake it in the ambient air The level of condensation of moisture in the air will indicate the level of liquid remaining in your device.
  • Page 25 8.3.1. GT 2, 3, 9, 11, 21 and 35 - Long holding time series GT 2 GT 3 GT 9 GT 11 GT 21 GT 35 MIN (cm) MAX (cm) Table 1: Full fill levels (canister + samples) - Long holding time series 8.3.2.
  • Page 26 7. After 24 hours, measure and record the weight displayed on the scale, as well as the time and room temperature. 8. Use the table below to compare the D+24h weight with the D weight, and calculate the container loss: If the loss is less than the “Warning daily evaporation”...
  • Page 27 8.5. Using the device Validate the following step before starting a device: Action Regularly check the liquid nitrogen level using the level gauge provided (see section 8.2). Comments relating to use: These accumulations will be Due to the cryogenic temperatures, ice or water may form. collected in a controlled way.
  • Page 28 protective equipment. The cap will remain closed as long as possible to avoid loss of cold and ice formation. The cap is equipped with a safety system (additional accessory for GT2). We recommend that you lock your apparatus (with an additional padlock) and never leave the key in the safety system.
  • Page 29 not damage the accessories. It is indispensable to place all of the storage units inside the container, even if they are empty. A storage unit that has not been conditioned to the temperature of the container before insertion will cause a significant temperature increase and a safety risk for the user.

  • Page 30: Cleaning And Maintenance

    9. Cleaning and maintenance 9.1. Emptying the device Emptying the device is a maintenance operation that must be carried out by trained and authorised personnel. Remove the frozen samples first and transfer them to another cryogenic device. 9.2. Servicing the device Servicing is required to ensure the equipment remains in good working order.
  • Page 31 Only spare parts made by Cryopal may be used for maintenance. The use of non- Cryopal spare parts may affect the safety of this medical device, and releases Cryopal from all liability in the event of an incident. The device will no longer be covered by warranty if non-Cryopal spare parts are used.
  • Page 32 10. Help 10.1. What to do if you are splashed by refrigerated liquid nitrogen When handling nitrogen to fill the device, there is a possibility it may splash into your eyes and/or on your skin: In the eyes Wash the eyes with plenty of water for at least 15 minutes; Follow the first aid procedures in place in your workplace;...
  • Page 33 10.3. Stuck cap Cause Solution Cap frozen onto the neck of the If thoroughly stuck, attempt to defrost the cap using a hot air device device no warmer than 60°C. The cover can be removed for easier access to the frozen areas. Then continue to defrost the container completely.
  • Page 34 Only Cryopal accessories are approved for use with our devices. The use of different accessories may affect the safety of this medical device, and releases Cryopal from all liability in the event of an incident. The device will no longer be covered by warranty if different accessories are used.
  • Page 35 Product ref. Description Function ACC-BOXTUBE- Metal tube-holder canes for six 2 ml tubes or Removing/handling three 5 ml tubes tubes ACC-BOXTUBE- Lids for plastic canisters with diameter of 35 mm Closing canisters ACC-BOXTUBE-6 1 ml cryo-tube ACC-BOXTUBE-11 2 ml cryo-tube Storing samples ACC-BOXTUBE-16 5 ml cryo-tube...
  • Page 36 Product ref. Description Function ACC-STEELCAN-3 GT40 stainless steel canister ACC-STEELCAN-4 GT26 stainless steel canister ACC-STEELCAN-6 GT38 stainless steel canister ACC-STEELCAN- Set of 6 GT3 stainless steel canisters ACC-STEELCAN- Set of 6 stainless steel canisters with 2 levels for GT11/21/35 ACC-STEELCAN- Set of 6 stainless steel canisters with 1 level for GT11/21/35 ACC-STEELCAN-...
  • Page 37 12. Disposal 12.1. Device If you wish to dispose of your device, contact the relevant maintenance team who are responsible for its disposal. 12.2. Accessories All waste caused by using the device (tubes, etc.) must be disposed of through the appropriate waste treatment channels.
  • Page 38 Note 38 | G T – U s e r m a n u a l...
  • Page 39 39 | G T – U s e r m a n u a l...
  • Page 40 40 | G T – U s e r m a n u a l...

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