Tanques Criogenicos - English

Espace
cryogenic containers
User manual
www.cryopal.com
Copyright 2016 by Cryopal
Document code: NH78455– Revision A

November 2016 edition
English version.
Year 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 Directive 93/42/EC concerning medical devices.
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
Fax: +33 (0)1 64 76 16 99
Email: [email protected] or [email protected]
Website: http://www.cryopal.com
2|ESPACE – User manual

Table of contents
1. IDENTITY OF MANUFACTURER------------------------------------------------------------------------------------------------ 5
2. SAFETY INFORMATION --------------------------------------------------------------------------------------------------------- 6
2.1. GENERAL INSTRUCTIONS ------------------------------------------------------------------------------------------------------ 6
2.2. GENERAL PRECAUTIONS FOR USE---------------------------------------------------------------------------------------------- 7
2.3. PRECAUTIONS IN THE EVENT OF FAULTS--------------------------------------------------------------------------------------- 9
2.4. DESCRIPTION OF LABELS ------------------------------------------------------------------------------------------------------- 9
2.5. KEY TO SYMBOLS ------------------------------------------------------------------------------------------------------------ 10
3. ESPACE DEVICE------------------------------------------------------------------------------------------------------------------ 11
3.1. DEVICE OVERVIEW ----------------------------------------------------------------------------------------------------------- 11
3.2. TECHNICAL SPECIFICATIONS ------------------------------------------------------------------------------------------------- 14
3.3. OVERVIEW OF THE PRODUCT RANGE ---------------------------------------------------------------------------------------- 17
4. USAGE INSTRUCTIONS -------------------------------------------------------------------------------------------------------- 18
4.1. INTENDED USE --------------------------------------------------------------------------------------------------------------- 18
4.2. EXPECTED PERFORMANCE --------------------------------------------------------------------------------------------------- 18
4.3. DEVICE SERVICE LIFE --------------------------------------------------------------------------------------------------------- 18
4.4. CONTRAINDICATIONS -------------------------------------------------------------------------------------------------------- 18
4.5. POTENTIAL ADVERSE EFFECTS ----------------------------------------------------------------------------------------------- 18
4.5.1. User ------------------------------------------------------------------------------------------------------------------ 18
4.5.2. Device --------------------------------------------------------------------------------------------------------------- 19
5. MATERIALS USED -------------------------------------------------------------------------------------------------------------- 20
6. STORAGE AND HANDLING CONDITIONS --------------------------------------------------------------------------------- 21
6.1. STORAGE--------------------------------------------------------------------------------------------------------------------- 21
6.2. HANDLING ------------------------------------------------------------------------------------------------------------------- 22
7. MOVING THE DEVICE ---------------------------------------------------------------------------------------------------------- 23
8. USING THE ESPACE DEVICE -------------------------------------------------------------------------------------------------- 24
8.1. FILLING THE DEVICE ---------------------------------------------------------------------------------------------------------- 24
8.2. NITROGEN LEVEL CHECK ----------------------------------------------------------------------------------------------------- 25
8.3. FILLING LEVELS--------------------------------------------------------------------------------------------------------------- 26
8.3.1. ESPACE 151 -------------------------------------------------------------------------------------------------------- 27
8.3.2. ESPACE 331 -------------------------------------------------------------------------------------------------------- 30
8.3.3. ESPACE 661 -------------------------------------------------------------------------------------------------------- 35
8.4. USING THE DEVICE ----------------------------------------------------------------------------------------------------------- 38
8.4.1. Opening the cap -------------------------------------------------------------------------------------------------- 38
8.5. INSERTING OR REMOVING SAMPLES ----------------------------------------------------------------------------------------- 40
8.6. HANDLING THE REVOLVING BASKET ----------------------------------------------------------------------------------------- 41
9. CLEANING AND MAINTENANCE -------------------------------------------------------------------------------------------- 42
9.1. EMPTYING THE DEVICE ------------------------------------------------------------------------------------------------------ 42
9.2. SERVICING THE DEVICE ------------------------------------------------------------------------------------------------------ 42
9.3. PREVENTIVE MAINTENANCE ------------------------------------------------------------------------------------------------- 43
10. HELP ---------------------------------------------------------------------------------------------------------------------------- 44
10.1. WHAT TO DO IF YOU ARE SPLASHED BY REFRIGERATED LIQUID NITROGEN ------------------------------------------------- 44
10.2. WHAT TO DO IN THE EVENT OF AN ACCIDENT ------------------------------------------------------------------------------- 44
10.3. STUCK CAP ------------------------------------------------------------------------------------------------------------------- 45
11. ACCESSORIES ---------------------------------------------------------------------------------------------------------------- 46
12. DISPOSAL --------------------------------------------------------------------------------------------------------------------- 50
12.1. DEVICE ----------------------------------------------------------------------------------------------------------------------- 50
12.1. ACCESSORIES ---------------------------------------------------------------------------------------------------------------- 50

1. Identity of manufacturer
The manufacturer of the ESPACE 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
Fax: +33 (0)1 64 76 16 99
Email: [email protected] or [email protected]
Website: http://www.cryopal.com

2. Safety information
Before using the ESPACE device, read this manual and the following safety instructions
carefully.
2.1. General instructions
You are only authorised to operate and use the equipment mentioned in this document if you
have read through this entire manual and all safety instructions and have been trained in the
risks associated with handling cryogenic fluids.
It is recommended that a back-up liquid nitrogen tank is available at all times so that samples
may be transferred in the event of a malfunction.
The device described in this manual is designed exclusively for use by qualified personnel.
Maintenance operations should only be carried out by qualified personnel authorised by the
manufacturer. To ensure the safe and correct use of the device during service and
maintenance, it is essential that all personnel observe standard safety procedures.
In the event the cryogenic equipment does not seem to function correctly under normal
usage conditions, only someone who has been fully trained by the manufacturer is allowed to
work on the cryogenic device and its peripheral components. Users must not take action
themselves due to the health and/or safety risks. In order to avoid the loss of too much cold,
the time until the maintenance technician performs servicing must be as short as possible.
The installation of remote monitoring options or devices will improve the safety of the
cryogenic system. Regular inspections must also take place.
Important / User information ** When storing biological samples classified as sensitive by

the user, Cryopal recommends using the ESPACE 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.
For ESPACE devices not equipped with the Cryomemo regulation system, Cryopal
recommends the liquid nitrogen level in the device be checked continuously. The test
described in section 8.2 is used to confirm that the equipment’s thermal performance is still
within the manufacturer’s recommended parameters.

2.2. General precautions for use
Wear personal protective equipment (PPE) when handling the device:
Protective cryogenic gloves are compulsory. You must never touch objects tha
that have
been in contact with liquid nitrogen with your bare hands.
resistant protective overalls (long sleeves) are recommended

Fire-resistant
Protective goggles are compulsory
Foot protection is recommended
/ Oxygen meter
Protection
The general precautions for use are the same for all cryogenic tanks:
Liquid nitrogen is extremely cold ((-196°C).

196°C). The parts of the tanks that have been in
contact with liquid nitrogen, especially while filling the tanks, may cause cold burns if
tact with the skin.
they come into contact
Cold burns and/or frostbite

On the neck and cap, after opening or while filling.
By liquid nitrogen splash when opening or removing fittings.
On the lock, during or immediately after filling
On the neck and the cap after opening
Liquid nitrogen may spill out of the device when handling accessories and fittings.
To avoid burns, it is recommended to never touch the cold parts of the equipment
(neck, cap, tube, etc.) and to always wear the personal protective equipment lilisted
in the safety instructions.
Trapping
By the cap when closing the device.
Crushed feet

By the castors, and the cryogenic device when handling.
Regular checks of the evaporation rate provide assurances that the product has
retained its original characteristics (see section 8.3)
Check there is no frost on the neck or outer casing of the device on a daily basis. If
there is, stop using the cryogenic device and immediately contact your distributor
responsible for maintenance.
Check the condition of the cap (deterioration of the polystyrene, uncoupling of the
cover). If there is substantial wear and tear, replace the cap to help maintain the
device’s performance.
If liquid nitrogen drips onto the pump check valve, it may no longer be leaktight. If this
occurs, check that all traces of frost have disappeared from the neck after 24 hours.
Contact your maintenance team in the event of spillage on the valve.
It is recommended to use the device on a flat, even surface to ensure it remains

stable.
The liquid nitrogen used in the storage containers evaporates in the air: 1 litre of
liquid nitrogen releases around 700 litres of gaseous nitrogen. Nitrogen is an inert,
non-toxic gas, but displaces oxygen when released into the atmosphere. Once the
atmospheric oxygen content falls below 19% the human body is at risk.
All rooms and areas that house storage tanks containing liquid nitrogen should be
well ventilated at all times and equipped with at least one oxygen gauge. All
personnel should be informed of the risks associated with the use of nitrogen.
Refer to current guidelines and contact your distributor.
The device must be filled with cryogenic liquid nitrogen in a well-ventilated area
(outside) or in a room equipped with a constant ventilation system adapted to the size
of the room. The room must also be equipped with an oxygen monitoring system with
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 faults
Full safety cannot be guaranteed in the following cases:
The container is visibly damaged.
After prolonged storage in unsuitable conditions.
After severe damage sustained during transit.
The container loses its thermal performance (see section 8.1)
If you suspect that the container is no longer safe (for example as a result of damage
sustained during transit or during use), it should be withdrawn from service.
Make sure that the withdrawn equipment cannot be accidentally used by others. The
apparatus should be handed over to authorised technicians for inspection.
2.4. Description of labels

Labels found on the ESPACE device
2.5. Key to symbols
Important: Low
Manufacturer
temperature
Refer to the instruction

Gloves must be worn
manual
Goggles must be worn Ventilate the room
Do not touch frosted parts Product reference code
CE marking, complies with

Serial number
Directive 93/42/EC
Date of manufacture Capacity in litres
10 | E S P A C E – U s e r m a n u a l
3. ESPACE device
3.1. Device overview
The devices in the ESPACE product range are unpressurised cryogenic tanks used to store
and preserve biological specimens that have been previously frozen in liquid or gaseous
nitrogen at -196°C (liquid/gaseous nitrogen is a cryogenic fluid).
The main features of the ESPACE tank family are:
ESPACE tanks are particularly well-suited to preserving large quantities of biological

samples over long periods.
All devices in the ESPACE range are designed for gaseous or liquid phase storage.
Figure 3-1: Cross-section of the ESPACE liquid/gas tanks
Cryomemo equipment is recommended for use with the device in gaseous phase.
ESPACE devices are available with user accessories as described in section 11.
The devices are equipped with a support interface for mounting the Cryomemo regulation
and automatic filling system.
Cap with assisted lifting, easy to handle (option).
Option to close with a standard key lock.
A special step (optional) is required to ensure correct usage of the ESPACE 661.
The devices are equipped with revolving baskets at the neck to make it easier to access
samples.
Phase
Cryogenic device Revolving

basket
ESPACE 151
ESPACE 331
ESPACE 661
Availability of a collar to quickly change the storage type (switch to gaseous or liquid
phase if the model accepts it).
Light alloy construction, for reduced weight and longer holding time.
Availability of varied storage systems adapted to vials, tubes, straws, bags, etc.
The devices must only be used for storing products in liquid or gaseous nitrogen,
depending on the type of device, and not for freezing. Any other gas is prohibited.
If preserving the products in a cryogenic device is identical whether it is in gaseous or

liquid state, the state is chosen according to the following medical considerations:
Cryogenic device in
Reason for selection Gaseous Liquid phase

phase
Frozen products in contact with liquid nitrogen No Yes
The use of gaseous nitrogen as opposed to liquid nitrogen:
Minimises the risks of cross-contamination
Increases user safety by preventing splashes when handling
Reduces the weight of the racks when handling
For safety reasons, gaseous phase storage may require an automatic filling system. The
container needs to be connected to a liquid nitrogen source.
3.2. Technical specifications
Description:
1 5
Figure 3-3: Blowing the level gauge wells (F) and filling
safety wells (E).
Figure 3-2: General view of an ESPACE 151 (left) and 331 or

661 (right) cryogenic tank.
The items available to the user are identical for all models and are detailed below.
No. Part Function
1. Filling safety Location of the sensor that prevents nitrogen overflow. (Designed for
sensor well the Cryomemo configuration)
2. Key lock Locking the cap (with assisted caps only).
3. Assisted cap lid Closes off the top opening in the tank using an integrated
mechanical device at the rear that bears some of the cap’s weight
and makes it easier to open and close.
4. Lifting handle Available only on the ESPACE 331 and ESPACE 661, makes it
easier to handle the lid (3).
5. Level gauge Location of the capacitive sensor for measuring liquid nitrogen
well levels. (Designed for the Cryomemo configuration)
Tanks Cryopal
Name ESPACE 151 ESPACE 331 ESPACE 661
Unpressurised containers intended for the storage and preservation, at a very low
Purpose
temperature in a liquid or steam state, of previously frozen biological samples.
Contraindic Do not use outside of the temperature/humidity ranges stated in the notice. Do not fill
ations the tank with anything other than liquid nitrogen.
Performanc
Maintain a cryogenic temperature to preserve biological samples
e
Operational
10 years
lifetime
Revolving Without revolving Without revolving With revolving
With revolving basket
basket basket basket basket
Gaseo
Material Liquid Gaseous Liquid us Liquid Gaseous Liquid Gaseous
held nitrogen nitrogen nitrogen nitroge nitrogen nitrogen nitrogen nitrogen
n
Tank
Stainless steel, aluminium alloy (basket)
material
Total
200 33 386 68 390 68 786 222
capacity (L)
Diameter of
538 538 777 777 740 740 1003 1003
neck (mm)
Diameter
NK NK NK NK NK NK NK NK
(mm)
230 231
230 232
stream stream
streamli streamli
Weight lined/1 lined/1
ned/190 ned/190
when empty 165 165 90 90 275 275
non- non-
(kg) non- non-
streamli streamli
stream stream
ned ned
lined lined
Full weight 545 285 546 286
326 192 890 435
(kg) streamli stream stream streamli
ned/505 lined/2 lined/5 ned/245
non- 45 05 non-
streamli non- non- streamli
ned stream stream ned
lined lined
Access
1205 1205 1172 1172 1172 1172 1355 1355
height (mm)
Total height
1350 1350 1310 1310 1310 1310 1505 1505
(mm)
Length
NK NK NK NK NK NK NK NK
(mm)
Width (mm) NK NK NK NK NK NK NK NK
Evaporation
(in L/day of 6 6 9 9 9 9 11.5 11.5
liquid)
Holding
33 5.5 43 7 43 7 66 17
time (days)
Materials in
direct or
indirect
Stainless steel, aluminium alloy, brass, copper, polycarbonate
contact
with the
user
Work area volume:
The table and figure below show the space needed depending on the type of cryogenic tank.
A
A
B
F B
F
C E
D D E
Figure 3-4: Peripheral volumes required - streamlined
Figure 3-5: Peripheral volumes required - non-streamlined
version.
version.
ESPACE 151 ESPACE 331 ESPACE 661

Without Without
Streamlining With streamlining With streamlining
streamlining streamlining
A 1855 mm 2070 mm 2070 mm 2520 mm
B 1465 mm 1432 mm 1432 mm 1615 mm
C 670 mm 906 mm / /
D 940 mm 1100 mm 1100 mm 1375 mm
E 650 mm 932 mm 886 mm 1150 mm
F 1205 mm 1172 mm 1172 mm 1355 mm
3.3. Overview of the product range
References Product description
ESP151N-LC-01 ESPACE 151 Liquid streamlined without

equipment
ESP331N-LC-01 ESPACE 331 Liquid streamlined without

equipment
ESP331N-LNC-01 ESPACE 331 Liquid non-streamlined without

equipment
ESP661N-LNC-01 ESPACE 661 Liquid non-streamlined without

equipment
4. Usage instructions
4.1. Intended use
Tanks in the ESPACE range are designed for use in laboratories or hospital settings for the
preservation and storage of biological samples.
Samples could be cord blood, blood bags, cells...
4.2. Expected performance
The expected performance of this device is that it maintains a cryogenic temperature for
preserving biological samples.
The -150°C temperature is guaranteed if the lid is closed, with normal filling conditions.
4.3. Device service life
The vacuum of the ESPACE devices is guaranteed for 6 years. The service life of the
ESPACE device is 10 years under normal usage conditions.
The device’s service life can only be maintained if all of the recommendations made in this
manual are followed.
4.4. Contraindications
ESPACE tanks must only be used within the temperature and humidity ranges specified in
the user manual, and only with liquid phase nitrogen (see section 6).
4.5. Potential adverse effects
4.5.1. User
There are two major adverse effects linked to the use of liquid nitrogen:
1. Cold burns or cryogenic burns

2. Anoxia
In order to avoid these adverse effects, follow the safety instructions provided in this manual.
4.5.2. Device
There are two major adverse effects linked to the use of liquid nitrogen:
1. Deterioration of the cap: Damage to the cap foam over time and risk of the cap’s
plastic shell cracking.
2. Leakage from the pump check valve: If liquid nitrogen drips onto the pump check
valve, it may no longer be leaktight.
If liquid nitrogen spills over onto the valve, check that all traces of frost have
disappeared from the neck within 24 hours, and conduct a thermal performance
inspection of the device by following the nitrogen level inspection protocol (see section
8.2).
5. Materials used
Materials in direct or
indirect contact with the Stainless steel, aluminium alloy, brass, copper, polycarbonate
user
6. Storage and handling conditions
There are several conditions and safeguards to follow so that ESPACE 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.
Do not store the equipment near heat sources.
Temperature and humidity ranges during storage (in the device’s original packaging):
-
Ambient temperature: -30°C to 60°C
-
Relative humidity: 0% to 85% without condensation
-
Atmospheric pressure: 500 hPa to 1150 hPa
Ensure that there is sufficient ventilation in areas where liquid nitrogen is stored or used,
because liquid nitrogen evaporates and produces large quantities of nitrogen gas, which
can reduce the amount of oxygen in the surrounding air in confined spaces and lead to a
risk of anoxia. A reduction in atmospheric oxygen levels is unnoticeable when breathing
in, so anoxia results in a loss of consciousness then death without any warning signs.
An oxygen meter, linked to a powerful audio and visual indicator, must be installed near
any storage or extraction site.
The device must not be stored in a small, enclosed space (such as a cabinet or closet).
The devices must be kept upright at all times.
This list is not exhaustive.
6.2. Handling
Once the cryogenic tank has been brought on site, it must be placed in the desired
location and the castors immobilised using the in-built brake.
Brake
Figure 6-1: The brake on a castor.
Temperature and humidity ranges during operation:

-
Ambient temperature: 20°C ±5°C, away from direct sunlight
-
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.
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
by rolling on its castors instead.
This movement is only possible and safe over very short distances (tens of centimetres) in
order to access the rear of the device during maintenance.
If the cryogenic container has already been used and must be moved to another location, it
must be transported empty and in its original packing, complying with the requirements set
by current national and international regulations.
It is forbidden to move a cryogenic device when it is full of liquid nitrogen and

contains samples.
Cryogenic devices are not approved for storage in outdoor environments.
Special care must be given to the valve when moving the device to avoid any
mechanical shocks.
8. Using the ESPACE device
8.1. Filling the device
When filling the device for the first time, refer to the Maintenance Manual NH78456. The first
filling must be carried out by a trained and approved member of staff.
The tank must be filled while empty and the samples will only be inserted after the device is
loaded with liquid nitrogen.
The medical device is filled by directly pouring liquid nitrogen through the neck using the
flexible transfer hose (suitable for cryogenic applications and compliant with the EN 12484
standard) connected to either a storage tank or a transfer line.
For storage in gaseous nitrogen, the maximum liquid level must be 145 mm for the ESPACE
151 and 331, and 117 mm for the ESPACE 661 (to be checked using a level gauge).
If the device to be filled is hot, it must not be all filled up at once to avoid the risk of splashes.
It must be first be filled ¾ of the way, and then left to cool for several minutes before filling it
up to the top.
If the device being filled already contains some liquid nitrogen, it can be filled entirely in a
single operation.
If the medical device is hot at first, the insulation will not be fully efficient until after
48 hours.
Liquid nitrogen losses will be high in the first hours and will generally be above the
specifications for the first two days. If you are looking for maximum holding time, it is a
good idea to top up the liquid nitrogen two or three days after filling.
During filling and transfer operations, make sure to use appropriate equipment and follow
procedures which guarantee safety (hoses, vacuum valve).
We recommend that at least one person should be present at all times to monitor filling
until completion.
Special care must be given to the valve when filling the device to preserve the cold.
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.
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.
There may be a difference between the measurements taken using the level indicator
and readings taken with a ruler, depending on the reference points used for the
measurements.
To guarantee monitoring and maintenance of the device’s performance, regular

inspections of the evaporation rate are recommended depending on their respective
holding times (see section 0).
The results of these measurements can be recorded in a control chart to track the
device’s parameters (number of fills, daily consumption, evaporation rate, etc.)
The device naturally empties by evaporation, and must therefore be topped up

regularly to ensure samples are preserved effectively.
If the evaporation rate is abnormally high in normal usage conditions, this means
there is a problem with the vacuum. This also manifests as transpiration and the
formation of frost on the outer casing. All necessary measures must be taken to
protect the contents of the refrigerator. If these problems persist, contact the
manufacturer.
8.3. Filling levels
The following acronyms are used:
Acronym Meaning
NS Maximum liquid nitrogen filling level.
NI Minimum liquid nitrogen filling level.
NI-NS NI-NS is the adjustable minimum difference (10%) between high and low
levels
Table 1: The alarm thresholds listed are the default values (factory settings).
8.3.1. ESPACE 151
Products can be stored in liquid or gaseous state.
Additional information (ESPACE 151)
Liquid quantity Liquid phase Gaseous phase
Useful liquid volume 193 27

(litres)
Relationship between the measurement scale and liquid quantity remaining

(values can vary slightly)
Measurement Liquid phase Gaseous phase

scale
Stationary tank 5 5
0% 5 5
20% 43 9
40% 80 14
80% 155 23
100% 193 27
Figure 8-1: ESPACE 151 - liquid phase - measurement scale.
Figure 8-2: ESPACE 151 - gaseous phase - measurement scale.
8.3.2. ESPACE 331
Additional information (ESPACE 331 with or without revolving basket)
Useful liquid volume (litres) 380 70

Measurement scale Liquid phase Gaseous phase
Stationary tank 23 23
0% 23 23
20% 94 32
40% 166 42
80% 309 61
100% 380 70
Figure 8-3: ESPACE 331 - liquid phase without revolving basket - measurement scale.
Figure 8-4: ESPACE 331 - gaseous phase with revolving basket - measurement scale.
Figure 8-5: ESPACE 331 - liquid phase with revolving basket - measurement scale.
Figure 8-6: ESPACE 331 - gaseous phase without revolving basket - measurement scale.
8.3.3. ESPACE 661
Additional information (ESPACE 661 with revolving basket)
Useful liquid volume 795 176

(litres)

Measurement scale Liquid phase Gaseous phase
Stationary tank 90 90
0% 90 90
20% 231 107
40% 372 124
80% 654 159
100% 795 176
Figure 8-7: ESPACE 661 - liquid phase with revolving basket - measurement scale.
Figure 8-8: ESPACE 661 - gaseous phase with revolving basket - measurement scale.
8.4. Using the device
Validate the following step before starting a device:
Action OK NOK
Regularly check the liquid nitrogen level using the level gauge
provided (see section 8.2).
Comments relating to use:
Due to the cryogenic temperatures, ice or water may form. These accumulations will be
collected in a controlled way.
The device must be inspected on a regular basis (external appearance, preserved

products, condition of the tank, actual liquid nitrogen level).
The installation of remote monitoring options or devices will improve the safety of the
cryogenic system.
Check there is no frost on the device’s neck on a daily basis. If there is, immediately
contact your distributor responsible for maintenance.
The operator must implement daily monitoring procedures for their installations (alarms,
etc.)
At the end of the usage period, the device must be left to warm up naturally. Thoroughly
dry the inside of the cryogenic tank by blowing with dry, de-oiled air.
8.4.1. Opening the cap
The person accessing the cryogenic device contents must be trained and authorised
to use it.
For optimal functionality, the cap must only be opened when handling equipment.
The cap is fitted with an insulation cover. Always handle the cap using personal
protective equipment.
The cap will remain closed as long as possible to avoid loss of cold and ice
formation.
The assisted cap is equipped with a mechanism to make it easier to open.
To open the assisted cap, lift the hood as

far as it will go using the special grooves. To
close again, reverse the movement.
Figure 8-9: Opening or closing the assisted cap - ESPACE 151
For the ESPACE 331 and 661, a handle is

provided for operating the cap. To open the
assisted cap, lift it as far as it will go. To
close again, reverse the movement.
Figure 8-10: Opening or closing the assisted cap - ESPACE

331 and 661
It is essential to always operate the assisted cap using the handle and follow the
movement until a complete stop.
The assisted cap is equipped with a key lock. It is recommended you leave the
cryogenic tank locked and never leave the key in the lock. Even though the
cryogenic tank is provided with several keys, you should keep a copy in case of
loss.
Opening the cap must be a voluntary action. The protection key, which is not an
anti-intrusion lock, allows limited access to authorised personnel; access to the
samples must be subject to other means of protection.
8.5. Inserting or removing samples
It is essential to use the approved personal protective equipment such as gloves,

protective clothing, goggles, etc.
Beware of the temperature of frozen products as well as the cold parts of the
devices.
Be careful not to damage the neck when inserting or removing the device’s racks.
The samples are generally placed in racks. These are

then put inside the cryogenic tank.
The storage conditions of the samples are the

responsibility of the operator.
Figure 8-11: Racks, canisters and goblets.
When handling racks, liquid nitrogen could spill out from the container. Personal
protective equipment, such as cryogenic gloves and visors, must be worn.
Gradually lift the accessories so the liquid nitrogen can flow without splashing up and to
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.
It is recommended to use aluminium racks as opposed to stainless steel racks to ensure

the temperature is as uniform as possible.
8.6. Handling the revolving basket
To handle the revolving basket, it is essential to use approved personal

protection equipment such as gloves, protective clothing, goggles, etc.
Beware of the temperature of frozen products as well as the cold parts of the
tank.
The cryogenic tank is equipped with a

Revolving basket
revolving basket to make it easier to access
Type Basic Optional the samples. To operate it, simply turn the
ESPACE basket along the grooves found around it.
151
ESPACE
331
ESPACE
661
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. This is the
operator’s responsibility.
Cleaning is required to ensure the equipment remains in good working order. This is the
operator’s responsibility.
The tools used for maintenance operations must be non-abrasive and should have no sharp
edges or points that could damage the surfaces.
• Defrosting the cap and neck (twice a month):

Lift and remove the cap from the neck, and use a protective cover on the neck to
prevent hot air and moisture entering the cryogenic tank. Let the cap ice melt in free
air. Wipe carefully before replacing the cap on the neck.
All ice and/or water must be recovered so that it does not fall into the device.
• Cleaning the outside of the device (once a month): Clean the outside of the device
only. The use of acetone, solvents or any other highly flammable or liquid chlorine-
based product is prohibited.
Wipe plastic parts with a dry cloth and if necessary with a slightly damp non-abrasive
sponge (do not use abrasive powder), or with impregnated wipes.
Ordinary domestic cleaning products (slightly abrasive creams containing ammonia)
applied with a sponge will be acceptable for the container and the stainless steel
parts. Afterwards, rinse with a damp cloth, then wipe and leave to dry.
Keep the container clean and in good working order.
Disinfecting and cleaning the inside of the medical device is possible if deemed
necessary. The must be carried out by someone who is trained and authorised in
technical maintenance.
The regularity of these checks is for guidance only, and can be adapted based on how
frequently the device is used.
9.3. Preventive maintenance

Maintenance is required to guarantee that the equipment remains within safety conditions. This is the responsibility of the device
operator. The device is not covered by warranty if maintenance has not been carried out in line with the manufacturer’s
recommendations.
Preventive maintenance operations must be carried out by technicians who have

received appropriate training and certification from the manufacturer.
Like every other device, your equipment may be subject to a mechanical failure.
The manufacturer cannot be held responsible for any type of stored products lost
as a result of this failure, even during the warranty period.
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.
Preventive maintenance of devices should be carried out according to the

manufacturer's instructions as given in the maintenance manual and updates (if
any).
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;
See a doctor.
On the skin
Do not rub;
Remove (if possible) or loosen your clothing;
Defrost the affected areas by gently and gradually warming them up;
Do not apply anything to the burnt area;
See a doctor.
10.2. What to do in the event of an accident
Cordon off the perimeter to prevent any further accidents;
Act quickly: the first aider must be equipped with personal protective equipment (stand-
alone respiratory protection equipment);
Carry out an emergency evacuation of the victim(s);
Ventilate the area;
Resolve the cause of the accident.
10.3. Stuck cap
Cause Solution
The lock is locked Unlock the lock
The lock is stuck and frozen De-ice the lock
The lock is stuck and not frozen Change the lock
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.
Be careful with the plastic parts (cap, outer panels, etc.).
All ice and/or water must be recovered so that it does not fall into the device.
11. Accessories
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.
CRYOPAL REF. PRODUCT DESCRIPTION
ACC-ESP-3 Full set of CECOS 4-sector partitions for ESPACE 151 (full set of 4)
ACC-BOXTUBE- Goblet/straw holder for ESPACE 151

305
ACC-BOXTUBE- CECOS top-down loading tray

413
ACC-ESP-2 Optional turntable for ESPACE 331
ACC-ESP-341 Step for ESPACE 661
ACC-ESP-344 Cleaning protection cover for ESP/RCB cap
ACC-BOXTUBE- Level gauge (manual measurement)

412
ESPACE devices are sold “bare” with no internal fittings, with the option to add the following
accessories:
Rack storage systems.
Availability of varied storage systems adapted to vials, tubes, straws, bags, etc.
Product ref. Description Function
ACC-ESP-330 Floor raiser for ESPACE 151 Gas

ACC-ESP-329 Floor raiser for ESPACE 661 Gas
Floor raiser for ESPACE 331 Gas
ACC-ESP-331
without turntable Organising
Floor raiser for ESPACE 331 Gas with
ACC-ESP-332
turntable
ACC-ESP-3 4-sector partition for Esp 151
ACC-BOXTUBE-6 NL 1 ml cryo-tube, flat-bottomed white

ACC-BOXTUBE-11 NL 2 ml cryo-tube white Storing samples
ACC-BOXTUBE-16 NL 5 ml cryo-tube white
ACC-BOXTUBE-305 Goblet/straw holder Handling goblets.
ACC-ESP-2 Turntable assembly for Esp 331 Facilitating access to samples
Facilitates access to the tank
ACC-ESP-341 Step assembly for Esp 661
neck
ACC-BOXTUBE-302 “Daisy” goblet
ACC-BOXTUBE-301 Versatile goblet, diameter 65 mm Storing straws
ACC-BOXTUBE-415 Pierced goblet, diameter 65 mm
ACC-BOXTUBE-3 Sight vial, diameter 10 mm
ACC-BOXTUBE-4 Sight vial, diameter 12 mm
Storing straws
ACC-BOXTUBE-5 Sight vial with stopper
ACC-BOXTUBE-1 Polygon sight vial
ACC-BOXTUBE-104 133 x 133 x 51 box, 100 2ml tubes
ACC-BOXTUBE-105 76 x 76 x 51 box, 25 2 ml tubes
Storing tubes
ACC-RACK-193 Rack of 10 and 80 x 9 x 96 case
Storing and protecting bags
Rack with 6 levels for 25 ml bags PALL
ACC-RACK-203
case
ACC-RACK-204
case
Storing bags
ACC-RACK-205
case
ACC-RACK-206
case
ACC-RACK-120 Racks 4 lvls 50 ml Esp 151
ACC-RACK-128 Set of 41 racks 4 lvls 50 ml
ACC-RACK-136 Set of 35 racks 4 lvls 50 ml
Full set of 71 racks with 4 levels for Storing straws, tubes and bags
ACC-RACK-143
5 ml bags for Esp 331 with turntable
ACC-RACK-10 Module for 50 ml bags
ACC-RACK-119 Set of 14 racks 7lvls Baxter 50
ACC-RACK-127 Set of 30 racks 7 lvls Baxter 50

ACC-RACK-37 Module for Baxter 50 7 lvls #
ACC-RACK-32 Module for gamb. DF700 2 lvls #
ACC-RACK-115 Set of 12 racks 4 lvls DF200
ACC-RACK-123 Racks 4 lvls DF200
ACC-RACK-131 Set of 25 racks 4 lvls DF200
Full set of 50 racks with 4 levels for
ACC-RACK-138
DF200 bags for Esp 661
ACC-RACK-38 Module for gamb. DF200 4 lvls
ACC-RACK-129 Racks 4 lvls Baxter 500
ACC-RACK-34 Module for Baxter 500 #
ACC-RACK-116 Racks with 2 levels for DF700 green
ACC-RACK-124 Set of 21 racks 2 lvls DF700 green
ACC-RACK-132 Racks 2 lvls DF700 green
ACC-RACK-139 Set of 38 racks 2 lvls DF700 green
ACC-RACK-174 Set of 8 racks 4 lvls DF700 (case)
ACC-RACK-35 Module 4 lvls For Baxter 750
ACC-RACK-146 Racks 13 lvls 2 ml tubes Esp 151
ACC-RACK-148 Racks 12 lvls 2 ml tubes Esp 331fp
ACC-RACK-150 Racks 12 lvls 2 ml tubes Esp 331pt
ACC-RACK-152 Racks 12 lvls 2 ml tubes Esp 661
ACC-RACK-5 Column with 12 lvls 133 x 133 x 51
ACC-RACK-6 Column with 13 lvls 133 x 133 x 51
ACC-RACK-8 Column with 12 levels 75 x 75 x 51

ACC-RACK-9 Column with 13 levels 75 x 75 x 51 #
ACC-RACK-147 Set of 7 racks 7 lvls box /81 5ml
ACC-RACK-149 Set of 17 racks 6 lvls 5 ml/81 Esp 331
ACC-RACK-196 Set of 7 racks 4 lvls pll Esp 151
ACC-RACK-198 Set of 15 racks 4 lvls pll Esp 331pt
ACC-PLASCAN-116 Set of 46 can. 5 lvls + 230 gob.
ACC-PLASCAN-104 Esp 330p equipment 88C5-440G
ACC-PLASCAN-105 Esp 330 equipment 97C-485G Storing samples
ACC-PLASCAN-106 Set of 163 can. 5 lvls + 815 gob.
ACC-PLASCAN-3 Plast. canister with 5 lvls + lifter
Cardboard case
ACC-BOXTUBE-253
CR750/DF700GSR7000
ACC-BOXTUBE-254 Cardboard case Pall25
ACC-BOXTUBE-250 Cardboard case CRY50/GSR1000AU
ACC-BOXTUBE-200 Baxter 30 ml bag case
ACC-BOXTUBE-203 Baxter 50 bag case
ACC-BOXTUBE-204 DF200/Baxter 250 bag case
ACC-BOXTUBE-205 DF200/B250 bag case
Cardboard case
ACC-BOXTUBE-251 Protecting bags
CR250/DF200GSR2000
ACC-BOXTUBE-201 Bag case for Baxter 500
ACC-BOXTUBE-202 Baxter 500 bag case
Cardboard case
ACC-BOXTUBE-252
CR500/DF170GSR5000
ACC-BOXTUBE-206 Bag case for DF700
ACC-BOXTUBE-207 DF700/Maco 700 bag case
ACC-BOXTUBE-208 Bag case for DF1000
ACC-BOXTUBE-255 DF1000 cardboard case
12. Disposal
12.1. Device
If you wish to dispose of your device, contact the relevant maintenance team who are
responsible for its disposal.
12.1. Accessories
All waste caused by using the device (tubes, etc.) must be disposed of through the
appropriate waste treatment channels.
If you have any questions, contact the maintenance team for your device.
Note
www.cryopal.com

Tanques Criogenicos - English

Uploaded by

Copyright:

Available Formats

Tanques Criogenicos - English

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Tanques Criogenicos - English

Uploaded by

Copyright:

Available Formats

Espace

Document code: NH78455– Revision A

Year of obtaining CE marking: 07/07/2005

Notified body: LNE GMED

2|ESPACE – User manual

4|ESPACE – User manual

The manufacturer of the ESPACE medical device is Cryopal:

5|ESPACE – User manual

2.1. General instructions

Important / User information ** When storing biological samples classified as sensitive by

6|ESPACE – User manual

Wear personal protective equipment (PPE) when handling the device:

resistant protective overalls (long sleeves) are recommended

Protective goggles are compulsory

Foot protection is recommended

Liquid nitrogen is extremely cold ((-196°C).

Cold burns and/or frostbite

7|ESPACE – User manual

It is recommended to use the device on a flat, even surface to ensure it remains

8|ESPACE – User manual

2.3. Precautions in the event of faults

Full safety cannot be guaranteed in the following cases:

The container is visibly damaged.

After prolonged storage in unsuitable conditions.

After severe damage sustained during transit.

The container loses its thermal performance (see section 8.1)

2.4. Description of labels

9|ESPACE – User manual

2.5. Key to symbols

Refer to the instruction

Goggles must be worn Ventilate the room

Do not touch frosted parts Product reference code

CE marking, complies with

Date of manufacture Capacity in litres

3.1. Device overview

The main features of the ESPACE tank family are:

ESPACE tanks are particularly well-suited to preserving large quantities of biological

Figure 3-1: Cross-section of the ESPACE liquid/gas tanks

Cap with assisted lifting, easy to handle (option).

Option to close with a standard key lock.

Cryogenic device Revolving

If preserving the products in a cryogenic device is identical whether it is in gaseous or

Reason for selection Gaseous Liquid phase

Frozen products in contact with liquid nitrogen No Yes

The use of gaseous nitrogen as opposed to liquid nitrogen:

Minimises the risks of cross-contamination

Increases user safety by preventing splashes when handling

Reduces the weight of the racks when handling

Figure 3-2: General view of an ESPACE 151 (left) and 331 or

No. Part Function

2. Key lock Locking the cap (with assisted caps only).

Work area volume:

ESPACE 151 ESPACE 331 ESPACE 661

3.3. Overview of the product range

References Product description

ESP151N-LC-01 ESPACE 151 Liquid streamlined without

ESP331N-LC-01 ESPACE 331 Liquid streamlined without

ESP331N-LNC-01 ESPACE 331 Liquid non-streamlined without

ESP661N-LNC-01 ESPACE 661 Liquid non-streamlined without