Cryotherm BIOSAFE 120, BIOSAFE 220, BIOSAFE 420 Operating Manual

Operating Manual

BIOSAFE® 120 / 220 / 420 MDß

Service – Hotline:

+49 (0) 2741-95 85 75

Contents

Inhalt

Seite

1 Introduction 1

1.1

Symbols in the Manual 1

1.2

Principle 2

1.3

Delivery 2

2 Component Overview 3

3 Cryogenic Storage Vessels

CHRONOS ® 120/220/420 4

3.1

Specifications of the Vessels CHRONOS ®

120/220/420 4

3.2

Structure of the Vessel 6

3.2.1

Combined Positive Pressure Relief and Seal-off

Device 6

3.2.2

Castors / Transport possibilities CHRONOS ® 120 7

3.2.3

Castors / Transport possibilities CHRONOS ®

220/420 8

3.2.4

Cover CHRONOS ® 120 9

3.2.5

Cover / Elevating Mechanism CHRONOS ®

220/420 10

3.2.6

Storage Shelf / Storage Frame

3.2.7

Connection for Level Control Unit and Vessel

Control System BIOSAFE – CONTROL ® ß

3.2.8

Fill Connection

12

12

13

4 Level Control Unit and Vessel Control System

BIOSAFE-CONTROL ® ß 14

4.1

Functions 14

4.2

Operating Elements

4.3

Assembly / Commissioning

4.4

Normal Operation

23

24

24

5 Safety 26

5.1

Safety advices

5.2

How to handle liquid Nitrogen

5.3

General Safety Instructions

5.4

Proper Use according to the Regulations

5.1

Safety Safety advices “Handling with cryogenic liquefied gases” Source: IGV Germany

5.2

Note Road Transportation

27

31

5.3

Labelling 32

26

26

26

26

6 Transport and Assembly

6.1

General Transport

33

33

6.2

Assembly 34

7 Operation 35

7.1

Installation / Assembly

7.1.1

Assembly of the Fill Line

7.1.2

Assembly of BIOSAFE-CONTROL ® ß

7.1.3

Connection of the liquid Nitrogen Supply

7.2

Initial Commissioning

35

35

36

36

37

7.3

Normal Operation

7.4

Storing and Taking-out of Samples

7.5

Putting out of Operation / Cleaning

38

40

41

I

II

Introduction

8 Accessories 42

8.1.1

Sorting System CHRONOS ® 120

8.1.2

Sorting System CHRONOS ® 220

8.1.3

Sorting system CHRONOS ® 420

42

45

48

9 Maintenance / Repair

9.1

Scope of Maintenance

9.2

Declaration of Decontamination

9.3

Spare Parts

52

52

54

55

10 Faults 56

10.1

General 57

10.2

Possible Faults CHRONOS ® 58

11 Warranty 60

1 Introduction

1.1 Symbols in the Manual

Introduction

BIOSAFE ® 120/220/420 MDß is a medical device of Class II a according to Directive 93/42/EWG of the Council of 14 June

1993 for medical devices.

With the medical device

BIOSAFE ® 120/220/420 MDß for example the following cell and tissue samples are long-term stored by using liquid nitrogen (LIN) as cryogenic agent at temperatures below -130° C for the return into the human being:

• sperm, ovum

• ancestral cells, bone marrow

• blood components, e. g. erythrocytes

• heart valves

• skin, bones, teeth as well as e. g.

• samples for the DNA – analysis in gene technology

The preconditions for this are

• that the samples are tightly packed in packaging suitable for liquid nitrogen temperatures.

• that the samples were deep-freezed correctly.

•

That the medical device BIOSAFE ® 120/220/420 MDß is operated properly according to the regulations.

Informs of dangerous situations resulting in possible

•

Personal injuries

•

Environmental damage

•

Machinery damage

Voltage hazard

Indicates

•

Advices

•

Exemplifications

•

Supplements

Warning of Squeezing Danger

1

2

1.2 Principle

1.3 Delivery

Introduction

The medical device BIOSAFE ® 120/220/420 MDß may only be operated according to this operating manual.

Before commissioning, it is absolutely necessary to read the operating manual completely.

The BIOSAFE ® 120/220/420 MDß may only be operated by trained and instructed personnel.

Immediately after receipt of the unit, check delivery with regard to

• completeness

• damage

In case of transport damage, inform

• transport insurance

• transport company

• supplier

Component Overview

The medical device BIOSAFE ® 120/220/420 MDß consists of two components:

•

Level control unit and vessel control system BIOSAFE –

CONTROL ® ß, with level probe, temperature probe, evaluation software for PC and holding device at CHRONOS ®

•

120/220/420

Cryogenic Storage Vessel CHRONOS

®

120/220/420 with designer cover with vacuum insulated panel, solenoid valve, cover switch and safety intermediate piece under a cover, insulated decanting hose

Optional component:

•

„I / O Box “ for connecting external alarms, main shut-off valve, analogue output for temperature documentation

Accessories:

Sale by:

Cryotherm GmbH & Co. KG

• aluminum sorting system

No medical device

3

3 Cryogenic Storage Vessels

CHRONOS ® 120/220/420

3.1 Specifications of the Vessels

CHRONOS ® 120/220/420

Cryogenic Storage Vessels CHRONOS®120/220/420

4

1. Width B

2. Depth T

3. Total height of Vessel H

(cover closed)

4. Assembly width A

5. Assembly depth D

6. Assembly width

BIOSAFE-CONTROL ® ß

7. Height with


CHRONOS ®

120

56 cm

70 cm

112 cm

80 cm

80 cm

80 cm

125 cm

CHRONOS

220

®

72 cm

85 cm

120 cm

80 cm

75 cm

95 cm

125 cm

CHRONOS ®

420

90 cm

103 cm

119 cm

96 cm

95 cm

110 cm

125 cm

Behälte


Wand

Position Deckel

D

G

Behälte

Deckel

J

J

H

8. Vessel height, cover opened H1

9. Space required: Depth F

10. Space required: Width G

11. Space required: Distance J

12. Space required: Distance J1

13. Space required: Height H3

14. Space required: Height H4

CHRONOS ® 220 CHRONOS ® 420

107 cm 107 cm

91 cm

141 cm

42 cm

55 cm

137 cm

168 cm

116 cm

175 cm

62 cm

75 cm

137 cm

168 cm

5

6


Total geometrical capacity

Geometrical capacity below the storage shelf (LIN reserve)

Geometrical capacity above the storage shelf (cubic capacity)

1decimetre filling height corresponds to

Operating overpressure

Empty weight

Outside diameter

Inside diameter

Storage height

Operating height (upper edge of the vessel with open cover)

Total height

Roller diameter

Static rate of evaporation

(measured with gas phase storage)

Holding time (LIN Reserve)

3.2 Structure of the Vessel

3.2.1 Combined Positive Pressure Relief and Seal-off Device

CHRONOS ®

120

151

21

130

21

0

100

560

514

625

1045

1150

2,3

3,5

4,5

CHRONOS ®

220

251

CHRONOS ®

420

415 l

35

216

35

57 l

358 l

57 l

1070

1180

80

2,0

5,0

0

175

710

664

625

5

0 bar

225 kg

900 mm

854 mm

625 mm

1070 mm

1190 mm

80 Mm

1,5 %/d

≈ 6,2 l/d

8 d

Caution! The positive pressure relief and seal-off device protects the vacuum room from overpressure. Re-evacuation may only be carried out by

• manufacturer’s skilled staff

The protective cover (2) intercepts the valve insert

(1), when there is overpressure existing in the vacuum room.

•

Do not remove the protective cover (2).

•

Protect the valve from heat as well as cooling, as brittleness results in the loss of the operating vacuum.

Transport possibilities

CHRONOS

®

120


As an option, the cryogenic storage vessel CHRONOS ® can be equipped with a roller base. This roller base features 4 casters, 2 of which are equipped with locking levers.

Transport with roller base

It is absolutely necessary to carry out transport over uneven grounds and stairs with 2 persons.

Transport with fork lifter

The CHRONOS ® 120 Vessel can be transported with a fork lifter.

Special fork lifter pockets are not provided. Therefore, it is absolutely necessary to secure the vessel with conventional means during the transport with a fork lifter.

Danger of tumbling down during unsecured transport.

It is absolutely necessary to secure the vessel at the fork lifter with suitable means (tightening straps) before transport.

7

8


Transport possibilities

CHRONOS

®

220/420

The cryogenic storage vessel CHRONOS ® 220 is equipped with 2 fixed castors without locking levers in the rear area and two adjusting feet in the front area. Thus, it is ensured that the vessel is stable in operating condition and cannot be moved without special devices

For the transport of Vessel CHRONOS ® 220/420 , two possibilities are given:

- by means of the additional transport device (article no.

78202830)

- by means of a fork lifter

Transport with transport device

The transport device (article no. 78202830) is intended for transporting vessels over small or middle distances (mainly inside buildings) and for shunting inside the laboratory.

The transport device is a frame with handle, two castors and a hemispherical journal placed in the lower area.

At the vessel bottom (in the front area), there exists the corresponding accommodation for hemispherical journals of the transport device (marked with a green arrow label).

By means of the transport device, the vessel is slightly lifted in front, is thus placed on four castors and can be moved.

.

Danger: trapping of the fingers

By means of the transport device, hindrances up to a height / depth / width of 20 mm (e. g. steps) can be overcome.

Danger: Due to the weight of the vessel, the handle of the transport device can hit back. Do not let go of the transport device during transport.

Transport with fork lifter

The CHRONOS ® 220/420 Vessel can be transported with a fork lifter.

Special fork lifter pockets are not provided. Therefore, it is absolutely necessary to secure the vessel with conventional means during the transport with a fork lifter.

Danger of tumbling down during unsecured transport.

It is absolutely necessary to secure the vessel at the fork lifter with suitable means (tightening straps) before transport.

3.2.4 Cover

CHRONOS

®

120


Adjustable feet (CHRONOS 220/420)

The feet at CHRONOS 220/420 can be adjusted in height.

For this, loosen the upper lock nut first and then adjust the foot with the lower nut in height or depth.

Subsequently, tighten the upper lock nut again.

CAUTION

Do not unscrew the foot completely!

The vessel is equipped with a detachable cover. The cover reduces the penetration of humidity and minimizes the penetration of additional heat into the vessel.

A lock is integrated in the cover. Thus, the access to the contents of the vessel is limited.

Danger at the lock: trapping of the fingers

For handling the cover, two cover handles are provided.

The handles of the vessel are exclusively intended for operating the cover and must not be used for any other purposes.

Opening of the vessel cover

First of all, unlock the lock for opening the vessel. After that, the cover has to be lifted.

Should any frost formation be apparent at the cover, remove it with open cover!

Closing the vessel cover

For closing the vessel cover, put the cover on the vessel again. Shut the lock after closing.

Danger at the lock: trapping of the fingers

9

3.2.5 Cover / Elevating Mechanism

CHRONOS

®

220/420

The vessel is equipped with a liftable - slewable cover. The cover reduces the penetration of humidity and minimizes the penetration of additional heat into the vessel.

A lock is integrated in the cover. Thus, the access to the contents of the vessel is limited

Danger at the lock: trapping of the fingers

For handling the cover, two cover handles are provided.

The handles of the vessel are exclusively intended for operating the cover and must not be used for any other purposes.

Cover opening mechanism

The cover opening mechanism serves for facilitating the opening and closing of the cover. The cover opening mechanism consists of a lifting mechanism with integrated gas pressure spring.

The pressure inside the gas pressure spring is adjusted in such a way that the cover cannot leave the vessel completely itself. This pressure ensures the perfect function of the cover opening mechanism

The pressure inside the gas pressure spring has to be examined during the annual maintenance and readjusted, if necessary.

Opening of the vessel cover

First of all, unlock the lock for opening the vessel. After that, the cover has to be lifted upwards to the limit stop and subsequently swivelled aside. In tilt-out condition the cover is blocked and protected against falling down.

After opening, block the cover by tilting-out aside.

Possible frost formation at the cover edge can possibly result in the fact that the cover does not move upwards itself after opening the lock handle.

For opening, loosen the cover at the handles with lateral movements and moderate pulling upwards.

Should any frost formation be apparent at the cover, remove it with open cover!


10


Closing the vessel cover

For closing the vessel cover, swing back the cover first, so that the cover is located above the vessel. At the same time, the blocking is loosened. After that, carefully lower the cover. Shut the lock after closing.

Danger at the lock: trapping of the fingers

EMERGENCY - PROCEDURE

In case that the lifting mechanism is obviously blocked with closed or opened cover, carry out the following emergency procedure after consulting the CRYOTHERM – SERVICE

(Hotline: 02741 – 95 85 75):

Opening: Loosen 4 fastening screws between cover and lifting mechanism. The cover can then be lifted with 2 persons.

Closing: Loosen the cover as described and insert into the vessel as much as possible in slightly turned position.

11

3.2.6 Storage Shelf / Storage

Frame


The storage shelf is a storage level loosely inserted into the vessel and is located on a storage frame made of aluminum.

Picture:

CHRONOS ® 220/420

3.2.7 Connection for Level Control

Unit and Vessel Control System

BIOSAFE – CONTROL

®

ß

Right picture:

The level probe of BIOSAFE-CONTROL ® ß is inserted into the splash guard pipe (center) provided for this.

Left picture:

Between the LIN fill line (left) and the splash guards pipe

(right) for the level probe, there exists the instrument leads for the temperature probe of the BIOSAFE-CONTROL ® ß

12


The fill connection is a detachable 3/8” screwed pipe.

At this connection, the decanting of the LIN supply is connected.

The fill pipe ends inside the vessel below the cover insulation and is slightly bevelled.

It prevents the splashing of the level probe or of the sorting system.

13

Level Control Unit and Vessel

Control System

BIOSAFE-CONTROL® ß

4 Level Control Unit and Vessel

Control System

BIOSAFE-CONTROL ® ß

4.1 Functions

Languages

•

The device display readings and the PC software can be set to German or English . Combinations are possible, too, i. e. German display and English PC software or German PC software and English display.

Level control

•

The level of the liquid nitrogen inside the storage vessel is kept between minimum and maximum.

•

If the level falls below minimum, a solenoid valve is triggered and liquid nitrogen continues flowing into the storage vessel.

•

A delayed reaction between 0 and 999 minutes can be selected for the magnetic valve (1) . This delay cannot be set for “Filling after Min. Alarm” and “Manual Filling”.

•

The filling procedure is stopped as soon as the level reaches the maximum level.

•

If the level falls below the minimum alarm level or exceeds the maximum alarm level, a visual and acoustic alarm is triggered. In addition, an alarm output is connected..

•

The level and the operating states are displayed both at the device and at the PC.

•

Delay times for triggering an alarm can be set both at the device and via PC.

•

All alarms can only be activated or deactivated via a service menu in the PC software (1) . This menu can only be accessed by service personnel. At the time of delivery ex works all alarms are activated.

•

With opened cover, automatic refilling is suppressed.

Manual refilling (e. g. for unfogging) is possible.

•

The distances between the sensors of the level probe

(standard design) are as follows:

Minimum alarm to minimum: 3 cm

Minimum to maximum: 4 cm

Maximum to maximum alarm: 3 cm

•

Alternatively there is a level control probe spaced at

2 cm/2cm/2cm. If required, please contact the manufacturer or service.

•

In order to set the requested level in the storage vessel, the vessel probe has to be inserted more or less deeply into the instrument leads provided for this.

14


Control System


Temperature - Control

•

The temperature inside the storage vessel is controlled, displayed (at the device and the PC) and logged.

•

If an adjustable limiting value for the storage temperature is exceeded longer than the period of time selected for this, an alarm is recorded, displayed and triggered.

•

The values for the storage temperature are stored every 15 minutes.

•

If the temperature is above the limit, the log rate for the temperature values is increased from 1 reading every 15 minutes to 1 reading per minute. Thus the progression up to exceeding the limiting temperature is displayed with a higher resolution and is thus more accurately traceable.

•

A graphic evaluation of the temperature course can be carried out via PC.

•

Delay times for triggering an alarm and the maximum allowable storage temperature can be set both at the device and via PC

•

Display range: -200 °C to +50 °C

Cover control

•

The opening condition of vessel cover is determined by means of a cover switch.

•

The opening of the cover is registered and indicated.

•

If an adjustable period of time is exceeded for cover opening, an alarm is triggered.

Note:

Vessels without a cover switch must be bridged.

15

16


Control System


Display/Indication

•

The display language can be set to German or English.

•

On the display are indicated;:

- level (between minimum and maximum)

- messages (operating state, information, alarm messages)

•

In addition, the

- vessel no. (= ID) (1 to 32)

- date and time (prevailing)

- date and time of an occurred alarm message and

• information on:

- data connection to the Master („M“)

- automatic refilling is triggered („F“)

- device is switched „inactive“ ( „ i “ ) are indicated.

•

With alarm messages, the background lighting of the display flashes.

Acoustic and visual alarm

•

With alarm messages, the background lighting of the display flashes.

•

On the display, the prevailing alarm is indicated in plain text.

•

In addition to the visual alarm message, an acoustic warning takes place.


Control System


Horn off

Acknowledge alarm

• Switches-off the acoustic alarm (no recurrence, but a new alarm triggers the horn again)

• Acknowledges the alarm / switches-off the horn / resets the alarm relay

• If an alarm condition does no longer exist, the alarm message is erased from the display

(goes to normal operation)

• If an alarm condition still exists, the alarm message is also still indicated / horn and alarm relay are reset for 30 minutes and return after this period of time

•

All alarms can be activated and deactivated via a service menu in the PC software (1) . This menu is only accessible by service personnel. When delivered ex works all alarms are activated.

Data storage

•

Each device stores data about:

- storage temperature

- operating states (solenoid valve / open cover)

- alarm messages

•

If the system is online, the data is directly transmitted to the PC

•

Approx. 3 days before the data storage fills up, a message is displayed. Once the data storage is full, the alarm “Memory full“ is triggered and the oldest data in the device memory will be overwritten.

Note:

The user can activate and deactivate the alarm

“Memory full” on the device.

When resetting this alarm, an existing alarm

“Memory full” is reset.

If data are not to be saved or no PC is connected, this alarm should always be deactivated!

When the alarm “Memory full” is deactivated, the data will still be saved but once the data storage is full the oldest data will be overwritten without previous warning.

The data can be viewed and edited (graphics, lists, printouts) even when the alarm is deactivated.

17

18


Control System


•

The number of all sets of data transferred from the devices to the PC is displayed after the start of the programme under “No. of Data Records”.

•

The data transfer from the device to the PC is shown on a progress bar.

•

At regular intervals backup files of the PC software’s current database are created. The backup intervals and the backup directory can be set by the user.

•

The user can also freely select the database directory for the current database. Thus the PC software features network connectivity!

Collective filling

For all devices with which the function „collective filling“ is active, it applies that all devices start the refill process as soon as one of the connected devices has started a refill process.

This accelerates for example the cooling of a LIN transfer line and minimizes cooling losses. active/inactive

The devices can be switched „active“ and „inactive“.

If a device is switched inactive, it keeps all its vesselspecific properties, like e. g. level control and temperature control!

Values and alarms are still indicated on the display of the device.

•

Alarms from this device are no longer transferred.

•

Central functions such as “Collective filling” or

“Main Shutoff Valve” can no longer be used.

•

The device works as a standalone system.

Parameters

Parameter and vessel information can be set on the device and in the PC software for each vessel individually.

Alarm output for external alarm

•

Each device is equipped with an output (potential-free change-over contact).

•

An external alarm system can be connected to this alarm connection


Control System


Redundant minimum alarm and maximum alarm control

•

Regardless of software and the microprocessor, the condition „minimum alarm“ and „maximum alarm“ is controlled via a separate hardware.

•

Also with troubles with software and microprocessor, an alarm is switched and displayed (flashing display and horn) when falling below the level „minimum alarm“ and exceeding the level „maximum alarm“

Note:

A hardware alarm is only displayed by faster flashing of the display and an increased alarm-sound-interval. No alarm message is displayed.

The display is still set to “normal operation”.

[1]

•

The Re-cooling function is available via a service menu in the PC software. This service menu can only be accessed by service personnel.

•

When the adjustable “Start temperature for Recooling” is exceeded, the vessel is filled to “Max.”, thus lowering the storage temperature.

•

Border conditions: Fill level below “Max.” and lid closed

•

Filling due to exceeding the “Start temperature for Recooling” does not trigger “Collective filling”.

•

Factory setting: Function is deactivated.

Data Output

•

Via the PC software data can be output in various formats:

- Temperatures as a text file (CSV files, editable in

Excel)

- Temperatures, events and graphics as PDF files

- Temperatures, events and graphics as printouts directly from the printer

- Vessel and parameter settings as a PDF file

19

20


Control System


Software Versions / Downward Compatibility

•

There is an older PC software version and firmware version (device software) than the one described in this manual. Compatibility between the two versions is guaranteed!

Note

Devices using the older device software can be upgraded through the service!

•

During the system start the master scans the device for the oldest device software version in the system.

The functions and commands used throughout the system are based on this version (lowest common denominator)

•

The functions of the individual devices are not affected by this system version. The PC software functions are available to a limited extent only.

[1]

Important notice:

The menu items “Settings/System Service” and “Settings/Vessel Parameters/Service” are accessible by

Cryotherm personnel only.

Any changes may only be carried out by Cryotherm service personnel or personnel trained by Cryotherm!

Cryotherm does not accept any responsibility for changes made to these menues by the user.


Control System


•

Via the „I/O box“ external signals (switching states) to the device or messages (switching states / analogue values) from the device can be transmitted to external systems.

I The „ I / O box“ features the following inputs and outputs in detail:

No. Output

1 Voltage signal:

0 – 10 V DC

Function

Analogue output for temperature signal

(make contact)

(make contact) input

(make contact)

5 Change-over contact

(250 V AC / 5 A ; constant current

2 A)

6 Like No. 5

External alarm

External acknowledgement

Collective filling

Main valve

Fault

The storage temperature

(-200 o C to +50 o C) is output as analogue voltage signal at this output.

-200 o C…0 o C 1V…..9V

Bruch 0,5V

Kurzschluss 9,5V

0 o C +50 o C 9V

If this input is closed, an alarm message „external alarm“ occurs at BIOSAFE-CONTROL ® ß

The main valve closes and the relay „collective alarm“ switches.

With this, e. g. the alarm output of an oxygen deficiency control can be connected.

With this, an alarm message can be acknowledged externally.

With this, the function „collective filling“ can be activated via an external switch.

With this, a central main valve can be switched.

Two operating modes are available.

7 Like No. 5

8 Like No. 5

9 Like No. 5

10 Like No. 5

11 Like No. 5

12 Like No. 5

13 Like No. 5

Maximum alarm

Excess temperature

Collective alarm

Filling

Minimum alarm

Reserve 1

Reserve 2

If a fault occurs (probe short circuit, probe break) at the

BIOSAFE-CONTROL ® ß, this change-over contact switches („fault“).

If the level inside the vessel is above the maximum alarm probe, this change-over contact switches

(„maximum alarm“).

If the storage temperature is above the limiting temperature, this change-over contact switches („excess temperature“).

The collective alarm is sort of a master alarm.

If one of the up to 32 devices gives an alarm message, this change-over contact („collective alarm“) switches.

Switches parallely to the solenoid valve.

If the level inside the vessel is below the minimum alarm probe, this change-over contact switches („minimum alarm“).

See table below

See table below

21

22


Control System


An alarm or event can be assigned to each of the two reserve relays.

The settings can only be changed via a PC software menu which is only accessible to service personnel!

Reserve 1 and Reserve 2

Alarm: Events:

•

No Event

(Default)

•

No Event

(Default)

•

Minimum Alarm

•

Maximum Alarm

•

Excess Temperature

•

Max. Lid Opening Time

Exceeded

•

Vessel is Activ

•

Lid is Open

•

Magnetic Valve Activated

•

Temperature out of Category Temp.

•

Filling Time Exceeded

•

Temperature Limit

•

Filling Interval Exceeded

•

Temperature Sensor

Broken

•

•

•

Communication Error

T – Sensor Error

F- Probe-Head Error

•

Memory Full

•

External Alarm

•

Filling-Level probe Broken

•

Memory Almost Full

4.2 Operating Elements


Control System


Key button/ operating element

Esc

▲

▼

Input acknowledgement

(Return)

M

MANUAL FILL

A

AUTO FILL

SIGNAL OFF

ALARM QUIT

Function

• Menu upwards (overriding menu)

• Goes to overriding menu without taking-over the values

• Terminates the selection

• Goes to password polling, if the key is pressed for more than 5 seconds

• Menu items up

• larger

• Menu items down

• smaller

• Menu downwards (submenu)

• Takes-over the values / settings and goes to overriding menu

• Solenoid valves opens as long as the key button is being pressed

(e.g. for „unfogging“ )

• Function is inactive, if „max. alarm“ exists

• Function is inactive, if the level probe is defective

• Starts automatic refilling

• Function is suppressed, as long as the cover is opened

• Switches-off the acoustic alarm (no recurrence, but new alarm triggers horn again)

• Acknowledges the alarm / switches-off the horn / resets alarm relay

• If the alarm condition no longer exists, the alarm message is erased in the display (goes to normal operation)

• If the alarm condition remains, the alarm message is continuously indicated / horn and alarm relays are reset for 30 minutes and return after this time

23

4.3 Assembly / Commissioning

4.4 Normal Operation


Control System


For this, see separate operating manual BIOSAFE-

CONTROL ® ß

In normal operation, BIOSAFE-CONTROL ® ß controls the LIN level inside the storage vessel automatically between minimum and maximum!

At the display of BIOSAFE-CONTROL ® ß, this display can be seen.

In normal operation, the following conditions are given:

•

Temperature is displayed

•

Level is displayed

•

No error message on the display

•

No acoustic signal

The following display can be seen at the PC in normal operation:

24


Control System


Examination per Working Day

Daily and generally after starting the computer programme, the user is requested to subject the system to a visual examination. By this, a visual examination shall be carried out independently from the computer.

25

Safety

5 Safety

Cryotherm GmbH & Co. KG recommend that the user 5.1 Safety advices

5.2 How to handle liquid Nitrogen request an EU – Safety data sheet for liquid nitrogen at his gas supplier

Caution when handling liquid nitrogen!

Observe the following documents and procedures:

•

Safety advices „Handling with cryogenic liquefied gases ”

•

Information for the road transportation

•

When setting up in rooms, ensure good ventilation

(TRB 610)

•

Operation may only be carried out by persons instructed correspondingly (TRB 700)

•

Regulation for the Prevention of Accidents

Regulation by the Central Office for Safety and Health

BGR 500 Chapter 2.33 (former BGV B 6)

•

Occupational Safety Regulations

5.3 General Safety Instructions

5.4 Proper Use according to the

Regulations

For safe operation:

•

Do not carry out any mechanical and thermal work at the vessel (loss of vacuum).

•

Do not overcharge the tank.

•

Wear gloves and safety glasses.

Cryotherm GmbH & Co. KG does not assume any liability, if the vessel is changed or adapted without approval given by the manufacturer.

Cryotherm GmbH & Co. KG does not assume any liability, if the vessel is not properly used according to the regulations.

26

5.1 Safety Safety advices

“Handling with cryogenic liquefied gases”

Source: IGV Germany

Safety

27

28

Safety

Safety

29

30

IGV – Safety advice:

The original is in German language

Translations into other languages may be carried out by a qualified translation company

Safety

5.2 Note

Road Transportation

Safety

INFORMATION FOR ROAD TRANSPORTATION

CRYOGENIC LIQUEFIED GASES: suffocating non-toxic, non-caustic, non-inflammable, non-oxidizing – designation of the medium is indicated on the next page

HAZARDS

Heating results in pressure increase – danger of bursting.

Gas is having a suffocating effect without any observable symptoms.

The leaked liquid is very cold and evaporates rapidly.

Liquid causes heavy injuries through frostbite on skin and eyes.

Together with humid air, it generates fog.

Gas is heavier than air and spreads on the ground.

PROTECTIVE EQUIPMENT

Safety glasses, protective gloves or face protection, protective shoes

EMERGENCY MEASURES: IMMEDIATELY NOTIFY FIRE

BRIGADE AND POLICE

Stop the motor.

Secure the road and warn other road users.

Keep unauthorized persons away from the danger zone.

Stay on wind side.

LEAKAGE LOSSES

If possible, remove leakage losses.

Consult an expert.

Have leaked liquid evaporated.

Warn everyone - danger of suffocating existing in sewerage, cellars and pits.

FIRE:

In case of fire conditions, cool the vessel by means of a water spray jet.

FIRST AID:

Thaw frozen garments and remove them carefully.

Medical aid is required in case of frostbite symptoms.

31

32

5.3 Labelling

Safety

The vessels have to be labelled according to the regulations for hazardous goods for the respective employment.

Cryogenic liquefied Gases suffocating, Class 2 Figure and Group 3A

Number, Labelling, Designation of the

Medium

Figure and

Group

3A

Caution Marks

1977 nitrogen, cryogenic liquid

No. 2

Non-combustible and non-toxic gas;

No. 11

This side up;

This label has to be attached with the arrow heads pointing upwards.

Attention: max. filling pressure 2 bar

6 Transport and Assembly

6.1 General Transport

Transport and Assembly

Transport of the Vessel

•

Observe safety instructions

•

Keep upright, max. tilting angle of 10°

•

Lift and set down carefully.

•

Avoid impacts and strong shocks.

•

Transport the vessel only with closed cover.

CHRONOS ® 120

For the transport of Vessel CHRONOS ® 120 , two possibilities are given:

- by means of an additional roller base (article no. 78202845)


Transport with roller base

The roller base (article no. 78202845) is intended for transporting vessels on small or middle distances (mainly inside buildings) and for shunting inside the laboratory.

Transport should always by carried out by 2 persons!


CHRONOS ® 220/420

For the transport of Vessel CHRONOS ® 220/420 , two possibilities are given:

- by means of the additional transport device (article no.

78202830)


Transport with transport device

The transport device (article no. 78202830) is intended for transporting vessels on small or middle distances (mainly inside buildings) and for shunting inside the laboratory.

By means of the transport device, the vessel is slightly lifted in front, is thus placed on four castors and can be moved.


33

34

6.2 Assembly

Transport and Assembly

Danger: Due to the weight of the vessel, the handle of the transport device can hit back. Do not let go of the transport device during transport.

During internal and road transportation with vehicles, protect the vessel from tumbling down, shifting and damage (by stowing / lashing).

Assembly of the Vessel

•

Observe safety instructions.

•

Ensure good ventilation.

•

Consider place of operation.

•

Actuate the locking levers of the castors.

•

Only operate the vessel under "normal" room conditions (about 20°C, relative humidity about 65%); with larger deviations there exists the danger of frost formation.

•

Pay attention to even ground.

•

Do not expose the vessel to direct airflow (e.g. fans of technical systems) (danger of frost formation)

The feet with CHRONOS 220/420 can be adjusted in height.

7 Operation

7.1 Installation / Assembly

7.1.1 Assembly of the Fill Line

Operation

The BIOSAFE ® 120/220/420 MDß may only be operated by trained personnel !

The BIOSAFE ® 120/220/420 MDß may only be installed and commissioned (initial commissioning) by

Cryotherm Service staff or by personnel trained by the Cryotherm Service staff.

The fill line consists of:

1. Decanting hose DN10 , 1.5 metres, normally insulated

2. 90 o – screwing

Proceed as follows during assembly:

The fill line is fastened to its 90° elbow union with the union nut of the fill connection.

35

Operation

7.1.2 Assembly of BIOSAFE-

CONTROL ® ß

7.1.3 Connection of the liquid

Nitrogen Supply

For this, see separate operating manual BIOSAFE-

CONTROL ® ß

For the liquid nitrogen supply, the following requirements apply:

•

Supply pressure: 0.5 – 2.0 bar

•

Liquid nitrogen has to be available as much as possible directly at the connection of the connection line.

When connecting and exchanging the LIN – vessel, wear gloves and safety glasses.

Cooled connection lines (fill lines) may never be separated from the vessel or the supply line. Penetrating humidity can result in the freezing-in of the solenoid valve!

When connecting the fill line to the vessel or the supply line, please observe as follows:

•

After connecting the fill line, open the ball valve for the LINwithdrawal at the vessel or the supply line to a minimum.

•

By repeated pressing of the switch "filling" to "man.", rinse the fill line. Only then open the ball valve completely.

Connecting the connection line (fill line):

•

Screw the union nut (3) on the connection screwing (2) of the fill / withdrawal valve (1).

•

Tighten the union nut (3) with spanner. At the same time, counter hold with the spanner at the hexagon (2) of the connection screwing.

Retighten the union nut in cold condition.

36

7.2 Initial Commissioning

Operation

Observe safety instructions !

Caution !

Supply voltage

Caution when handling liquid nitrogen

•

Connect the connecting line.

•

Establish the filling pressure of liquid nitrogen supply.

•

Open the ball valve to the connecting line.

•

Check the connecting line for tightness.

Adjust the requested filling height by means of the level probe of BIOSAFE-CONTROL ® ß. For this, see separate operating manuals of

BIOSAFE-CONTROL ® ß

The initial filling of the vessel has to be carried out with open cover!

For operating BIOSAFE-CONTROL ® ß, see separate operating instructions of BIOSAFE-CONTROL ® ß

37

7.3 Normal Operation

Operation

In normal operation, BIOSAFE-CONTROL ® ß controls the LIN level inside the storage vessel automatically between minimum and maximum!

At the display of BIOSAFE-CONTROL ® ß, this display can be seen.

In normal operation, the following conditions are given:

•

Temperature is displayed

•

Level is displayed

•

No error message on the display

•

No acoustic signal

The following display can be seen at the PC in normal operation:

38

Examination per Working Day

Operation

Daily and generally after starting the computer programme, the user is requested to subject the system to a visual examination. By this, a visual examination shall be carried out independently from the computer.

39

40

7.4 Storing and Taking-out of

Samples

Operation

The CHRONOS

® Vessels should be open only for a short period of time. Prior to storing and taking-out, determine the position of the sample inside the vessel.

Caution!

•

Observe the safety instructions.

•

Observe the requirements of the sorting system.

•

Wear gloves and safety glasses.

•

The level is changed by the storing and taking-out of the towers. Due to this, the automatic level control can refill liquid nitrogen. There exists the danger of splashes.

•

The wrapping of the samples can be very brittle in intensely cooled condition. Caution when handling.

Storing

Always store only one tower or a similar sample vessel at once in the vessel (penetration of additional heat into the vessel).

•

Prior to storing, determine a free position for the sample inside the vessel.

•

Slowly open the cover. That limits nebulosity and improves the view on the sorting system.

•

Pull out the free tower and put it down on the other towers.

•

Store the marked sample in the free position determined before.

•

Put back the tower to its original place inside the

CHRONOS

® Vessel.

•

Close the cover.

Taking-out

•

Prior to taking-out, determine the position of the sample inside the container.

•

Slowly open the cover. That limits nebulosity and improves the view on the sorting system.

•

Pull out the tower with the desired sample and put it down on the other towers.

•

Take out the sample.

•

Examine the marking of the sample.

•

Put back the tower to its original place inside the

CHRONOS

® Vessel.

•

Close the cover.

7.5 Putting out of Operation /

Cleaning

Operation

When putting out of operation,

• empty the vessel completely.

When the vessel has reached room temperature,

Remove the storage shelf and storage frame.

Dry the vessel after putting out of operation.

Carefully dry the gap between inner vessel wall and inner vessel bottom!

Incomplete drying can result in a damage of the vessel !

(freezing-out of condensation water / corrosion)!

•

Clean the sample room, storage shelf and storage frame.

When cleaning the vessel, please observe as follows:

•

No temperatures exceeding 80°C.

•

Use only detergents compatible with plastics at the cover. If necessary, test compatibility first.

•

Use only detergents compatible with stainless steel at the vessel.

•

Decontaminate the vessel.

The positive pressure relief and seal-off valve contains an O-ring made of buna N. If necessary, avoid contact with the detergent.

When returning the vessel to the manufacturer, make sure to enclose the filled-in declaration of decontamination.

41

8 Accessories

CHRONOS

®

120

145 mm

42

CHRONOS ® 120,

Towers 78202833 and 78202834 (140x145 mm)

Towers 78202835, 78202836 (85x85 mm)

Accessories

166 mm

CHRONOS ® 120,

Towers 78202837 and 78202838 (140x166 mm),

Towers 78202835 and 78202836 (85x85 mm)

165 mm

Accessories

CHRONOS ® 120

Towers 77031511 ( 95 x 165 mm )

43

280 mm

CHRONOS ® 120

Towers 78202831 (80 x 280 mm)

Towers 78202835, 78202836 (85x85 mm)

305 mm

Accessories

44

CHRONOS ® 120,

Towers 78202832 (80 x 305 mm)

Towers78202835, 78202836 (85x85 mm)

CHRONOS

®

220

85 mm

80 mm

CHRONOS ® 220

Towers 78202832 (80 x 305 mm) and 78202835, 78202836 (85x85 mm)

85 mm

Accessories

140 mm

CHRONOS ® 220

Towers 78202837, 78202838 (140x166 mm), and 78202835, 78202836 (85x85 mm)

45

85 mm

140 mm

CHRONOS ® 220

Towers 78202833 and 78202834 (140x145 mm), and 78202835, 78202836 (85x85 mm)

85 mm

46

80 mm

CHRONOS ® 220


Accessories

95 mm

CHRONOS ® 220

Towers 77031511 (95 x 165 mm)

Accessories

47

48

CHRONOS

®

420

85 mm

95 mm

CHRONOS ® 420

Towers 77031511 (95x165 mm) and 78202835, 78202836 (85 x 85 mm)

Accessories

140 mm

CHRONOS ® 420

Towers 78202837, 78202838 (140x166 mm), and 78202835, 78202836 (85x85 mm)

140 mm

Accessories

CHRONOS ® 420

Towers 78202833, 78202834 (140x145 mm), and 78202835, 78202836 (85x85 mm )

49

80 mm

CHRONOS ® 420


50

CHRONOS ® 420


80 mm

Accessories

Accessories

Requirements:

Good thermoconducting material (e. g. aluminum) for producing a constant temperature distribution inside the vessel. For this, a complete insertion of the vessel according to the sketch is absolutely necessary.

The sorting system and the sample wrappings (e. g. bags or ampoules) have to match. A damage of the sample wrapping by the sorting system has to be excluded.

The position of each sample inside the vessel has to be clear and unmistakable by the sorting system and a corresponding labelling.

It has to be possible to fix the samples in their position.

The falling-out of the sample and the floating-out from the holding device has to be avoided.

The sorting system has to be adjusted to the vessel in height (The cover may not stand on the sorting system).

The sample wrappings and the labelling material have to be suitable for the application in liquid nitrogen.

The sample wrappings have to reliably prevent the liquid nitrogen from penetrating and the escaping of the wrapping contents.

Avoid the outer contamination of the sample wrapping.

51

9 Maintenance / Repair

52

9.1 Scope of Maintenance

Maintenance / Repair

Examination and maintenance work at the

BIOSAFE

® 120/220/420 MDß has to be carried out at regular intervals.

Maintenance and repair work may only be carried out by trained and instructed skilled personal.

Visual examinations and operational checks can be carried out by instructed users (operators).

Service Hotline

02741 - 95 85 75

Once a year, a maintenance has to be carried out.

This maintenance may only be carried out by:

•

Cryotherm service personnel

•

Skilled personnel specially trained for this medical device by the manufacturer

CHRONOS

®

:

• visual examination (outer condition, stability)

• examination for undue frost formation

• examination of the castors

• examine the cover for damage (handles, insulation, outer condition)

• examine the pressure in the gas pressure spring of the cover opening mechanism

• visual examination (outer condition) of the LIN line

• clean the solenoid valve, check the function

• clean the LIN filter

BIOSAFE-CONTROL ® ß:

Visual examination

• examination of outer condition

• fastening

• plug-in connections

• cables

• leadthroughs


Examination of all functions:

• temperature measurement

• displays

• switching functions automatic and manual filling

• alarm functions

• data transmission

• function of the software

• relay outputs alarm (I/O box, if required)

• examination of the set parameters

• examination of battery voltage, exchange if required

• examination of the electrical safety

We recommend a conclude a service contract with

Cryotherm GmbH & Co. KG for the yearly maintenance !

Additionally to the yearly maintenance, the following examinations have to be carried out by the user weekly:

• visual examination of the vessel and the connecting line

• check all connections for tightness (visual examinations)

• check the function of the solenoid valve

• visual examination of the electrical connecting cables

In addition to the weekly examination, the following examinations have to be carried out at the BIOSAFE-

CONTROL

®

ß by the user per working day:

53

9.2 Declaration of Decontamination


In case of returning the

BIOSAFE

®

120/220/420 MDß

(or parts), the declaration of decontamination must by all means be completed and enclosed.

54


9.3 Spare Parts

Spare Parts for CHRONOS

®

Vessels:

Spare parts for CHRONOS

®

CHRONOS

®

Vessels:

1.

Cover for

CHRONOS

®

120/220/420

2.

Roller base

3. Castor with a diameter of ∅ 80 mm without locking lever

4. Mini blow-off valve

5. Solenoid valve 3/8" DN5,6, 220V,

50Hz, 16,7 W, 7 bar

6.

Operating instructions

BIOSAFE

®

120/220/420 MDß

7.

Blind cap 1/4"

8.

Cryotherm logo

9. Lettering BIOSAFE ® MDß

10.

Rating plate BIOSAFE ® MDß

GGVS / ADR - labelling

11. GGVS adhesive label no. 2

12. GGVS adhesive label ↑↑ no. 11

13. Label liquid cryogenic nitrogen

14.

Operating manual


120

78202811

78202845

77031419

0346709

78203751

79404869

77031446

77031598

79421988

0358193

0356199

78400571

78203750

0358193

0356199

78400571

78203750

CHRONOS

®

220

78202810

77031491

77031419

0346709

78203751

79404869

77031446

77031598

79421988

CHRONOS

®

420

78202809

77031491

77031419

0346709

78203751

79404869

77031446

77031598

79421988

0358193

0356199

78400571

78203750

55

10 Faults

56

Faults

Faults at the level control unit and the vessel control system BIOSAFE - CONTROL

®

ß are visually indicated on the display and acoustically by a horn.

If the cause of the fault cannot be determined or removed, inform the manufacturer without delay.

Service - Hotline: +49 (0) 2741-95 85 75

The BIOSAFE ® 120/220/420 MDß has a LIN reserve below the storage shelf. This reserve guarantees the requested storage temperature of

≤

-130°C also with a minimum filling ratio (LIN – level in storage shelf height) for another

4.5 days

5 days

8 days with BIOSAFE ® 120 MDß with BIOSAFE ® 220 MDß with BIOSAFE ® 420 MDß after occurance of a fault in the liquid nitrogen supply.

This period of time only applies if the vessel is not opened during this time.

With higher filling ratio, this residual holding time is correspondingly higher (for this, also see the specifications of the vessel).

10.1 General

Faults

Immediately put the BIOSAFE ® 120/220/420 MDß out of operation, in case that

• the rate of evaporation is too high.

• the outer vessel is thawed / iced-up, which indicates loss of vacuum (does not apply during and immediately after filling)

•

Rearrange the samples before putting out of operation!

In case of nitrogen escaping,

• there exists the danger of suffocation.

• open windows and doors.

• leave closed rooms.

Vessels with vacuum loss are useless and have to be returned to the manufacturer for examination / repair.

In case of any queries, please indicate

• type

• system no.

• year of construction

57

Faults

10.2 Possible Faults CHRONOS ®

Fault

Level too low.

Cause Trouble shooting

The supply of liquid nitrogen is defective. Open the liquid nitrogen supply.

Examine the level and the pressure of the store tank and the function of the valves.

Fault at the level control unit and vessel control system BIOSAFE-CONTROL ® ß

See separate operating manual of

BIOSAFE-

CONTROL ® ß

Level too high, liquid nitrogen overflows, the cover floats

Supply of liquid nitrogen defective

Fault at the level control unit and vessel control system BIOSAFE-CONTROL ® ß

Close the supply of liquid nitrogen, check the function of the valves

See separate operating manual of

BIOSAFE-

CONTROL ® ß

Frost formation on the vessel

Upper vessel edge thawed This is operational after refilling or cooling-in.

Vessel is directly exposed to strong airflow dry up, if necessary avoid direct blowing against the vessel

Iced-up cover

Outer vessel iced-up

This is operational after frequent opening If necessary, remove the ice carefully

Loss of vacuum

The vessel is directly exposed to strong airflow.

Examination /

Reevacuation by the manufacturer avoid direct blow-against of the vessel

Positive pressure relief and seal-off device actuated, vessel extremely icedup

Loss of vacuum / pressure inside the vacuum room

Empty out the vessel / put it out of operation

Examination / repair at the manufacturer’s works

58

Faults

Fault

The cover cannot be opened.

Cause Trouble shooting

Possible frost formation at the cover edge can possibly result in the fact that the cover cannot be opened.

For opening, loosen the cover with lateral movements and moderate pulling upwards at the handles.

59

11 Warranty

Warranty

Our warranty requires the proper use of the device according to the regulations. When exchanging parts, only original spare parts have to be used. Wear parts are not subject to warranty.

Extent and duration of our warranty comply with the regulation indicated in our terms of delivery.

60

Cryotherm GmbH & Co. KG certified according to DIN EN 13485

Article No.. :• 78203751 y 1015

Subject to change

© Cryotherm GmbH & Co. KG

® registered trademark Cryotherm GmbH & Co. KG

Euteneuen 4

57548 Kirchen (Sieg)

Tel.: (02741) 9585-0 • Fax (02741) 6900

Cryotherm BIOSAFE 120, BIOSAFE 220, BIOSAFE 420 Operating Manual

Operating Manual

BIOSAFE® 120 / 220 / 420 MDß

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