Angelantoni Challenge 250 Service manual addendum

UNI EN ISO 9001 (ISO 9001)

UNI EN ISO 14001 (ISO 14001)

environmental chambers division

Biomedical Division

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Sistema Qualità Certificato

NATO AQAP110

06056 Massa Martana (PG)

e-mail : [e-mail]
fax : ++39 (75) 8955.200
tel : ++39 (75) 8955.1

ITALY

ADDENDUM

FOR THE

CHALLENGE 250 TC CHAMBER

for rapid freezing

INSTRUCTION HANDBOOK

TRADEMARK

Rel. 300603 Add16 Angelantoni industrie S.p.A.

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CONTENTS

ADDENDUM FOR USE ..................................................................................................................................................................................................................................................................3

FIRST START-UP .........................................................................................................................................................................................................................................................................3

FREEZING.....................................................................................................................................................................................................................................................................................3

DEFROSTING ...............................................................................................................................................................................................................................................................................3

PERIODS IN WHICH THE MACHINE REMAINS UNUSED.................................................................................................................................................................................................... 3

REPORT ...........................................................................................................................................................................................................................................................................................4

INTRODUCTION .......................................................................................................................................................................................................................................................................... 4

The CH 250 TC chamber can be used to rapidly freeze plasma.
If the equipment is used for this purpose, the following instructions must be followed.
The machine use handbook (“CHALLENGE SERIES” Use handbook) should still be consulted nevertheless.
In order to give an idea of the freezing times, the report on the experimental activity carried out at the Immunotransfusion Service at the old S.
Gerardo Hospital in Monza has also been attached.

Rel. 300603 Add16 Angelantoni industrie S.p.A.

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ADDENDUM FOR USE

FIRST START-UP

(or start-up after a long period in which the machine has remained with the START/STOP switch in the STOP position (warning light switched off) or with the main switch on

OFF).

1.1 Turn the main switch to ON.

1.2 If the START/STOP key is not in the START position (warning light switched on), an alarm message appears on the display.

1.3 Press the START/STOP key (the warning light must switch on).

1.4 Use the ACK key on the control panel to reset any alarm signal.

1.5 Wait approximately 8 hours.

1.6 Set the temperature at –70°C (see paragr. 3.1 of the use handbook for the OP7 control panel).

1.7 Press the K1 key to start the machine so that the led warning light switches on (see paragr. 3.1 of the use handbook for the OP7 control panel in the section entitled “TEST START-UP).

FREEZING

2.1 When the chamber has reached the temperature of –70°C, wait approximately 30’ to give the temperature time to stabilise inside the chamber itself.

2.2 Insert the bags inside the chamber trying to avoid placing one on top of the other and leave enough space for air to pass between one bag and another.

2.3 Close the door (when the machine is working, the door should remain open as little as possible).

2.4 Leave the bags inside the chamber for as long as is necessary (ref. attached report).

2.5 Remove the frozen bags and then close the door.

2.6 Repeat points 2.1….2.5 in order to carry out a new freezing cycle.

DEFROSTING

After a maximum of 6 freezing cycles (although it could be done earlier, depending on the environment in which the chamber is located and on the conditions in which it is used) the evaporator
should be defrosted in order to avoid ice accumulating, that could cause a problem for heat exchange.
In order to do so, follow the instructions below.

3.1 Press the K1 key to switch off the machine so that the led warning light switches off (whereas the START/STOP key warning light remains switched on)

3.2 Open the door of the chamber and leave it open for at least 12 hours (e.g. overnight) so that it defrosts.

3.3 When necessary, carry out operation 1.7 and start a new freezing cycle (stage n° 2).

PERIODS IN WHICH THE MACHINE REMAINS UNUSED

4.1 If the chamber remains unused for only a few days, proceed as follows.

- Press the K1 key to switch off the machine so that the led warning light switches off. However, leave the START/STOP switched on (warning light switched on) and the main switch in
the ON position.

- When necessary, carry out operation 1.7 and start a new freezing cycle (stage n° 2).

4.2 If the chamber should remain unused for a long period:.

- Turn the main switch to OFF in order to switch off the chamber.

- When necessary, carry out operations 1.1….. 1.7 and start a new freezing cycle (stage n° 2).

Rel. 300603 Add16 Angelantoni industrie S.p.A.

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REPORT

Report on the experimental activity carried out at the Immunotransfusion Service at the old S. Gerardo Hospital in Monza on 07-08/02/02

INTRODUCTION

Below is a list of the tests carried out on the CH250 TC –70/+180 S.N. 28250 equipment, used as a rapid freezer for bags of plasma at the Immunotransfusion Service at the old S. Gerardo
Hospital in Monza (Italy).

The tests to freeze the bags were carried out using the following measurement instrument:
FLUKE NET DAQ 2640 S/N ACS 195.
Test were carried out during a freezing cycle and the following temperatures were monitored:
Temperature inside the CH250 chamber – ref. “points 1,2,3,4,6,7,8,9” on the following graph -using eight “T” type thermocouples.
Temperature inside a sample bag (the probe was placed in such a way as to be completely immersed in the plasma ) –ref. “BAG” on the following graph - using a class A, PT100 probe with a
metal tube-shaped sensitive part, diameter 4 mm and length 150 mm, equipped with a tri-polar cable with teflon + silicone rubber insulation.

The thermocouples used to monitor the temperature inside the chamber were positioned according to the diagram in figure 1.

The environment temperature measured during the tests was approximately 25°C.

6

Working Chamber

9

1

4

Measuring useful
space. According to

8

DIN 50011.

3 2

FIG.1: The probes were placed at a distance of L/10 from the walls of the chamber (L = length of the side of the chamber).

Rel. 300603 Add16 Angelantoni industrie S.p.A.

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TEST with N° 30 plasma bags (250 ml capacity approx.)

30
25
20
15
10

TEMPERATURE (°C)

-10

-15

-20

-25

-30

-35

-40

-45

-50

-55

-60

-65

-70

-75

5
0

-5

FREEZING

POINT 1

POINT 2

POINT 3

POINT 4

BAG

POINT 6

POINT 7

POINT 8

POINT 9

0.00.00

Rel. 300603 Add16 Angelantoni industrie S.p.A.

0.05.00

0.10.00

0.15.00

0.20.00

0.25.00

0.30.00

TIME (hh.mm.ss)

0.35.00

0.40.00

0.45.00

0.50.00

0.55.00

1.00.00