Integra CELLROLL Manual de usuario

CELLROLL and CELLSP N Operating instructions

183411_V12

Declaration of Conformity | Konformitäts-

erklärung | Déclaration de conformité

INTEGRA Biosciences AG – 7205 Zizers, Switzerland

declares on its own responsibility that the products |

erklärt in alleiniger Verantwortung, dass die Produkte |

déclare sous sa responsabilité exclusive, que les produits

in accordance with the EC directives | gemäß der EU-Richtlinien |

sont conforme au terme de la directives CE

are in compliance with the following standards or normative documents: |

mit den folgenden normativen Dokumenten übereinstimmen: |

aux documents normatifs ci-après :

Standards for Canada and USA

Zizers, December 9 th

2013

ledom,epyTnoitpircseD

500681,100681LLORLLEC

100381NIPSLLEC

2006/95/EC Low voltage equipment

2004/108/EC Electromagnetic compatibility

2011/65/EC Restriction of Hazardous Substances

2002/96/EC Waste Electrical and Electronic Equipment

EN 61010-1 Safety requirements for electrical equipment

for measurement, control and laboratory use,

Part 1: General requirements.

EN 61326-1 Electrical equipment for measurement, control

and laboratory use - EMC requirements.

CAN/CSA-C22.2 No. 61010-1 Safety requirements for electrical equipment

for measurement, control and laboratory use,

Part 1: General requirements.

UL Std. No. 61010-1 Safety requirements for electrical equipment

for measurement, control and laboratory use,

Part 1: General requirements.

FCC, Part 15, Class A Emission

Elmar Morscher

CEO

Thomas Neher

Quality Manager

2.1 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Contents

1. Safety precautions

2. Technical data

4. Assembly and installation CELLROLL/CELLSPIN

3. Abrid ed operatin instructions CELLROLL/CELLSPIN

3.1 nstrument parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3.2 Description of keys and functions . . . . . . . . . . . . . . . . . . . . . 10

3.3 Abridged instructions CELLROLL . . . . . . . . . . . . . . . . . . . . . 11

3.4 Abridged instructions CELLSP N . . . . . . . . . . . . . . . . . . . . . . 13

4.1 Equipment provided - CELLROLL . . . . . . . . . . . . . . . . . . . . . 15

4.2 Equipment provided - CELLSP N . . . . . . . . . . . . . . . . . . . . . . 16

4.3 Control unit CELLROLL/CELLSP N . . . . . . . . . . . . . . . . . . . . 16

4.4 Designation of individual instrument parts . . . . . . . . . . . . . . 17

4.5 Vertical assembly - CELLROLL . . . . . . . . . . . . . . . . . . . . . . . 18

4.6 Horizontal assembly - CELLROLL . . . . . . . . . . . . . . . . . . . . . 19

4.7 Disassembly - CELLROLL . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4.8 Stirring unit - CELLSP N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

4.9 Connecting the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

4.10 Equipment disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Installation of CELLROLL/CELLSPIN: location and conditions . . . . . . . . . . . . 5

Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Conditions of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Dangers involved when safety precautions are not observed . . . . . . . . . . . . . 6

Safety at work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Qualification of operating personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Safety aspects for user company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Changes in configuration/design by user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

5.1 Operating steps

Starting and stopping the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Switching on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Selecting outputs (OUTPUT 1/OUTPUT 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Configuration of connected instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.2 CELLSP N - specific CELLSP N functions

Stirring - "SPEED" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Pendular stirring angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Interval mode "––" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

5.3 CELLROLL - specific CELLROLL functions

Rolling speed - "SPEED" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Rocking angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.4 CELLROLL/CELLSP N - common functions

Running time mode "" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Cycle mode "CYCLES" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Printout and overview of program parameters "PRINT . . . . . . . . . . . . . . . . . . . 30

Storing programs "STORE" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Recalling and viewing programs "RECALL" . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

6. Troubleshootin

7. Guarantee/Cleanin

5. Detailed operatin instructions

8. Manufacturer and Service Contacts

General

Throughout the manual, the following symbols will be used to indi-

cate general precautionary measures:

Indication: information on the correct use of

CELLROLL/CELLSPIN.

Warning: Warning that, if safety precautions are not

observed, damage may result to the instruments.

Please read all documentation.

Danger: Warning that, if safety precautions are not

observed, injury to personnel may result.

nstallation: Location and conditions

CELLROLL/CELLSPIN are intended for use in a laboratory.

Ambient conditions for the devices CELLROLL/

CELLSPIN see chapter Technical data

Warning: Always locate the control unit outside of an incu-

bator if used.

Avoid exposing the control unit and power supply to direct

sunlight or high humidity.

Locate CELLROLL in such a way that personnel

cannot come in contact with the cogs.

Transport

Always grip CELLROLL on the base when transporting

1. Safety precautions

Conditions of use

CELLROLL is a modular and expandable roller system for cell cul-

tivation and preparation of cell products in roller bottles. It is suit-

able for use with adherent cells and cell suspensions. The instru-

ment is not designed for any other applications and should there-

fore not be used for such.

CELLSP N is a spinning system comprising four stirring units for

the gentle cultivation of cells and the preparation of cell products in

spinning vessels. It is suitable for use with cell suspensions and immo-

bilised adherent cells (e.g. microcarriers/alginate inclusion). The instru-

ment is not designed for any other applications and should there-

fore not be used for such.

Dangers involved when safety precautions are not

observed

CELLROLL/CELLSPIN are state-of-the-art instruments with respect

to current technology and are safe to use. Some danger may exist

if the instruments are used by untrained personnel. Any person given

the task of operating CELLROLL/CELLSPIN must first read the oper-

ating and safety instructions and understand them fully or be thor-

oughly trained by a superior in the use of the instruments before

operating the instrument.

Safety at work

Independent of any safety precautions listed here, all other relevant

safety aspects - e.g. GLP, GMP, professional trade associations,

Department of Health, trade supervisory authorities - must be

observed.

Qualification of operating personnel

Normally, a technical qualification is required. Specialist knowledge

is required when using CELLROLL/CELLSPIN if all danger is to be

avoided.

Personnel without formal technical qualifications do not as a rule

possess such specialised information and should therefore only be

allowed to operate CELLROLL/CELLSPIN if properly trained and

under the supervision of suitably qualified personnel.

Safety aspects for the user company

The supervisors of operating personnel must have read and under-

stood all the safety precautions involved and must ensure that these

are adhered to. They must also ensure that operating personnel also

understand and observe all safety rules.

Prior to operating CELLROLL/CELLSPIN, the supervisor must ensure

that no other dangers exist, especially if other instruments and sys-

tems are also being used.

If necessary, additional safety instructions must be compiled by the

supervisor. The user company must, if necessary, in order to exclude

all possible danger, compile explicit safety instructions and have these

signed by the staff responsible. In addition, clear competences must

be established as to who is responsible for the operation of CELL-

ROLL/CELLSPIN so that these potential dangers can be reduced

to an absolute minimum.

Changes in configuration/design by user

No changes may be made to CELLROLL/CELLSPIN. Any parts that

become defective must be replaced by original INTEGRA Biosciences

parts.

CELLROLL/CELLSPIN may not be altered in design or in any of their

safety aspects without the express written permission of INTEGRA

Biosciences. In particular, no alterations may be made to any of the

protective functions. Any alteration made releases INTEGRA

Biosciences from any liability for damage caused.

Power requirements

Checking the power supply

Check the power supply at the location and ensure that it complies

with that of the instrument.

Indication: Using the wrong power supply may damage

electronic components in the instrument.

Connecting to the power supply

Connect CELLROLL/CELLSPIN to the power supply using the cable

provid ed.

Danger: The instrument may not be used if insufficient

protection is provided as this may expose personnel

to the danger of electrical current injury.

NB: When connecting or disconnecting the instrument

from the control unit the latter must always first be

switched off otherwise the electronics may be dam-

aged or a program interrupted.

2. Technical data

CELLROLL

Width Depth Height

1 Deck 295 mm 360 mm 240 mm

2 Decks 295 mm 360 mm 400 mm

3 Decks 295 mm 360 mm 560 mm

4 Decks 295 mm 360 mm 720 mm

Control unit: 295 mm 80 mm 60 mm

Speed: "Motor unit": 0.1 – 2.0 rpm

"Motor unit fast": 2.0 – 6.0 rpm

Power Supply:

Input: 100 – 240 VAC/47 – 63 Hz/1.6 A

Output: 9.5 VDC/4.0 A/38 W

Weight:

Motor unit: 1.85 kg

Deck: 1.7 kg

Operating Condition:

Operation

Motor-unit/ Deck: 5 – 40 °C/max. 99% RH/max. 10% CO2

Operation Control unit: 5 – 40 °C/max. 80% RH

Storage: -10 – 50 °C/max. 95% RH

Degree of protection:

Motor-unit/Deck: IP54

Control unit: IP21

2.1 Technical data

CELLSP N

Width Depth Height

Drive: 295 mm 330 mm 60 mm

Control unit: 295 mm 80 mm 60 mm

Speed: 5 – 75 rpm

Power Supply:

Input: 100 – 240 VAC/47 – 63 Hz/1.6 A

Output: 9.5 VDC/4.0 A/38 W

Weight:

Control unit: 0.5 kg

Stirrer unit: 2.9 kg

Operating Condition:

Operation Stirrer unit: 5 – 40 °C/max. 99% RH/max. 10% CO2

Operation Control unit: 5 – 40 °C/max. 80% RH

Storage: -10 – 50 °C/max. 95% RH

Degree of protection:

Stirrer unit: IP54

Control unit: IP21

3.1 nstrument parameters

3. Abrid ed operatin instructions

CELLROLL /CELLSPIN

Storing of programs – "STORE"

Memories Pr. 01 – Pr. 10

Recalling programs – "RECALL"

Pr. 01 – Pr. 10

CELLROLL

Motor unit fast (2 – 6 rpm)

"SPEED" for continuous rolling

(rolling with no directional change)

2.0 – 6.0 in steps of 0.25

and for rocking

(rolling with directional change)

ANGLE " " for rocking

(180° – 1440° in steps of 180°)

ANGLE ""for rolling = 0°

CELLSP N

"SPEED" for continuous stirring

(= continuous stirring)

5.0 – 40.0 rpm in steps of 2.5

40.0 – 75.0 rpm in steps of 5.0

"SPEED" for pendular stirring

(= stirring with directional change)

5.0 – 40.0 rpm in steps of 2.5

ANGLE " " for pendular stirring

(180° – 1440° in steps of 180°)

ANGLE ""continuous stirring = 0°

RUNNING TIME ""

(00.05 h.min. - 99.59 h.min.) or

unlimited = Con

Cycles – "CYCLES"

for programming

1 – 9999

CELLROLL

Motor unit (0.1 – 2 rpm)

"SPEED" for continuous rolling

(rolling with no directional change)

0.1 – 1.0 in steps of 0.1

1.0 – 2.0 in steps of 0.5

and for rocking

(rolling with directional change)

ANGLE " " for rocking

(180° – 1440° in steps of 180°)

ANGLE ""for rolling = 0°

Print-out of protocols – "PRINT"

or viewing stored programs P1

Protocol print-out P2

Print-out of stored programs P3

Storing of programs – "STORE"

Memories Pr. 01 – Pr. 10

Recalling programs – "RECALL"

Pr. 01 – Pr. 10

RUNNING TIME ""

(00.05 h.min. - 99.59 h.min.) or

unlimited = Con

PAUSE " "

(00.00 h.min. - 99.59 h.min.)

Cycles – "CYCLES"

for programming

1 – 9999

Print-out of protocols – "PRINT"

or viewing stored programs P1

Protocol print-out P2

Print-out of stored programs P3

3.2 Brief description of keys and functions

Keys:

ON/OFF: Switches the instrument on/off

SELECT: Switches between parameters. The corresponding green LED will light and the most

recently set value will appear in the display.

ENTER: or confirming the value entered.

∨/∧:Keys "∨" and "∧" alter the corresponding parameters stepwise, the values being shown on

the display.

By keeping keys "∨" and "∧" pressed, all parameter values are displayed in rapid sequence.

< >: or:

a) Changing e.g. from hours to minutes and vice versa when setting time.

b) Switching between OUTPUT 1 and OUTPUT 2 in the functions "SPEED" and "RECALL".

c) Activating/deactivating the print options P2 and P3 in the function "PRINT".

Function LED’s :

STORE: Storing of programs

PR NT: P1: Display of stored programs

P2: Setting the printing interval

P3: Print out of stored programs

RECALL: Recalling stored programs

PUMP: Additional function

CYCLES: Number of times a program should be repeated

: Angle for pendular/circular stirring and rocking/rolling

ALARM: Red lamp lights if there is malfunction

SPEED: Speeds for pendular/circular stirring and rocking/rolling and for selecting between

OUTPUT 1 and OUTPUT 2

–––– : Pause between two programmed runs

: Running time (specific/continuous) for pendular or continuous stirring, rocking or rolling

h/min: Activated during entry of time parameter

rpm: Activated during entry of speed

1213

515

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