HERAcell 150i and 240i Operating Instructions

Copyright 2009 Thermo Fisher Scientific. All rights reserved. These operating instructions are protected by copyright. Rights resulting thereof, particularly reprint, photomechanical or digital postprocessing or reproduction, even in part, are only allowed with the written consent of the Thermo Electron LED GmbH. This regulation does not apply to reproductions for in-plant use. The contents of the operating instructions are subject to change without further notice. Concerning translations into foreign languages, the German version of these operating instructions is binding. Trademarks HERAcell® and iCan™ are registered trademarks of Thermo Scientific. Thermo Scientific is a brand of Thermo Fisher Scientific Inc. All trademarks mentioned in the operating instructions are the exclusive property of the respective manufacturers. Thermo Electron LED GmbH Robert-Bosch-Straße 1 D - 63505 Langenselbold Germany Thermo Electron LED GmbH is a subsidiary company of: Thermo Fisher Scientific Inc. 81 Wyman Street Waltham, MA 02454 USA

® Operating Instructions | HERAcell 150i / 240i

Contents 1 General notes

9

1.1 Identification of the device and of the documentation... 10 1.2 Instruction of the operating personnel... 10 1.3 Applicability of the instructions ... 11 1.4 Warranty ... 11 1.5 Explanation of safety information and symbols ... 12 1.5.1 Safety information and symbols used in the operating instructions... 12 1.5.2 Additional symbols for safety informations: ... 12 1.5.3 Symbols on the device ... 13 1.6 Intended purpose of the device... 14 1.6.1 Correct use ... 14 1.6.2 Incorrect use... 14 1.7 Standards and directives ... 15 1.8 Safety notes on gases... 16 1.8.1 Safety notes on carbon dioxide (CO2) ... 16 1.8.2 Safety notes on oxygen (O2) ... 17 1.8.3 Safety notes on nitrogen (N2) ... 17

2 Delivery of the device

18

2.1 Packaging ... 18 2.2 Acceptance inspection... 18 2.3 Standard equipment components HERAcell® 150i... 19 2.4 Optional equipment components HERAcell® 150i ... 19 2.5 Standard equipment components HERAcell® 240i... 20 2.6 Optional equipment components HERAcell® 240i ... 21

3 Installation of the device

22

3.1 Ambient conditions... 22 3.2 Room ventilation ... 22 3.3 Space requirements ... 23 3.4 Transport ... 24 3.5 Stacking ... 24 3.6 Retrofitting/Modifications ... 25

4 Description of the device

26

4.1 Front view of HERAcell® 150i ... 26 4.2 Rear view HERAcell® 150i ... 28 4.3 Front view HERAcell® 240i ... 32 4.4 Rear view HERAcell® 240i ... 34 4.5 Safety devices ... 38 4.6 Work space atmosphere ... 38 4.7 Door switch ... 40 4.8 Sensor system... 41 4.9 Supply interface ... 42 4.10 Work space components ... 44 4.10.1 Interior container... 44 4.10.2 Optional split gas-tight screens ... 44 4.10.3 Water reservoir... 45 4.10.4 Gas humidification (optional, only for O2 control)... 45 4.10.5 Heating system... 45 50115191 A / 08.2009

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® Operating Instructions | HERAcell 150i / 240i

Contents 4.10.6 Rear panel openings ... 46 4.10.7 Shelf system ... 47 4.10.8 Bottle turning device for HERAcell® 240i (optional) ... 47 4.10.9 Water pump... 48

5 Start-up

49

5.1 Preparing the work space ... 49 5.2 Installing the shelf system ... 49 5.2.1 Installation/removal of the support rail ... 49 5.2.2 Installing the shelf supports: ... 50 5.2.3 Levelling the device ... 50 5.3 Installing the gas humidification (optional, only for O2/N2-control)... 50 5.4 Installing the optional bottle turning devices HERAcell® 240i ... 51 5.5 Installing the optional center strut HERAcell® 240i for split inserts... 54 5.6 Gas connection... 55 5.6.1 Installing gas pressure hoses ... 55 5.6.2 Installing devices without the optional gas monitoring system ... 56 5.6.3 CO2 connection with gas monitoring system (optional) ... 57 5.6.4 Combined CO2/O2/N2 connection with gas monitoring system (optional) ... 57 5.7 Power supply connection ... 59 5.8 Connecting the RS 232 interface ... 60 5.9 Connecting the USB interface (optional)... 60 5.10 Connecting the alarm contact... 61

6 Operation

63

6.1 Preparing the device ... 63 6.2 Starting operation ... 64

7 Handling and control (iCan™ touchscreen controller)

65

7.1 Power switch ... 65 7.2 Operating panel and operating structure... 65 7.3 Factory presettings of the iCan™ touchscreen controls... 68 7.4 Heat-up phase of the control loop sensors... 68 7.5 Event actions for settings ... 69 7.6 Setting the temperature set value ... 70 7.7 Setting the CO2 set value... 71 7.8 Setting the O2 set value ... 72 7.9 Auto-start routine ... 73 7.9.1 Activating auto-start... 75 7.9.2 Interrupting the auto-start routine ... 76 7.10 Running the contra-con routine... 76 7.11 User configuration... 76 7.11.1 Settings... 77 7.11.2 Event logging ... 83 7.11.3 Options ... 85 7.11.4 Icon description... 90 7.11.5 Enabling/disabling the keypad lock... 92 7.11.6 Software versions ... 93 7.12 Scaling the trend display ... 94 7.13 Error messages ... 95 50115191 A / 08.2009

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® Operating Instructions | HERAcell 150i / 240i

Contents 7.13.1 Response to an error message event ... 95 7.13.2 Troubleshooting ... 95

8 Shut-down

99

8.1 Shutting the device down... 99

9 Cleaning and disinfection

100

9.1 Cleaning ... 100 9.2 Decontamimation procedures ... 101 9.3 Wipe/spray disinfection ... 101 9.4 contra-con decontamination routine... 104 9.4.1 Activating the contra-con routine... 107 9.4.2 Interrupting contra-con ... 107 9.4.3 contra-con interruption due to error ... 108 9.4.4 Completing contra-con ... 109

10 Maintenance

110

10.1 Inspections and checks... 110 10.2 Service intervals ... 110 10.3 Preparing the temperature calibration ... 111 10.4 Temperature calibration procedure ... 112 10.5 Preparing the CO2 calibration ... 113 10.6 CO2 calibration procedure ... 115 10.7 Replacing the gas inlet filter... 116 10.8 Replacing the device fuses ... 116 10.9 Replacing the door seal ... 117

11 Disposal

118

12 Technical data

120

13 Annex: Data communication

124

13.1 Interfaces ... 124 13.1.1 RS 232 interface ... 124 13.1.2 USB port (optional) ... 124 13.1.3 Installing the USB port driver ... 125 13.2 Structure of the command sequences for data communication ... 127 13.2.1 Description of the protocol ... 127 13.3 Overview of general parameters (addresses 0xxx) ... 128 13.3.1 Reading general parameters ... 128 13.4 Overview of incubator parameters (addresses 2xxx)... 129 13.4.1 Reading basic parameters ... 129 13.4.2 Reading internal function parameters ... 130 13.5 Error memory structure ... 132 13.5.1 Error memory data set structure scheme:... 133 13.5.2 Overview of the possible error messages in hex coding... 133

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® Operating Instructions | HERAcell 150i / 240i

Contents 13.5.3 Overview of the possible error messages in bit coding... 134 13.6 Data logger structure ... 136 13.6.1 Data logger data set structure scheme:... 137 13.6.2 Overview of possible event entries in bit coding ... 138 13.7 Examples of data logger codes ... 140 13.7.1 Functions for data logger queries ... 140 13.7.2 Example of a code for a a data logger query... 140 13.8 Program Heracell 150i & 240i... 145 13.8.1 Installing the Heracell 150i & 240i... 146 13.8.2 Operating the Heracell 150i & 240i ... 147

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14 Device log

154

15 Certificate of decontamination

155

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Betriebsanleitung | HERAcell

®

150i / 240i

Figures Fig. 1: Device dimensions... 23 Fig. 2: Lift points ... 24 Fig. 3: Stacking ... 24 Fig. 4: Front view HERAcell® 150i ... 27 Fig. 5: Rear view HERAcell® 150i ... 29 Fig. 6: Looped-through gas supply HERAcell® 150i... 31 Fig. 7: Front view HERAcell® 240i ... 33 Fig. 8: Rear view HERAcell® 240i ... 35 Fig. 9: Looped-through gas supply HERAcell® 240i... 37 Fig. 10: Door switch ... 40 Fig. 11: Temperature, CO2,and O2 sensors ... 41 Fig. 12: Supply interface ... 42 Fig. 13: Work space components ... 44 Fig. 14: Water reservoir... 45 Fig. 15: Rear panel openings ... 46 Fig. 16: Bottle turning device... 47 Fig. 17: Water pump... 48 Fig. 18: Support rail installation/removal ... 49 Fig. 19: Shelf support installation ... 50 Fig. 20: Installing gas humidification ... 50 Fig. 21: Installing the bottle turning devices ... 51 Fig. 22: Bottle turning speed... 53 Fig. 23: Center strut installation... 54 Fig. 24: Installing gas pressure hoses ... 55 Fig. 25: Gas connection without gas monitoring system... 56 Fig. 26: Gas connection with gas monitoring system (optional) ... 57 Fig. 27: Combined connection with gas monitoring system (optional)... 58 Fig. 28: Combined gas connection with gas monitoring system... 59 Fig. 28: Power supply connection ... 59 Fig. 29: Connection example ... 62 Fig. 30: Power switch ... 65 Fig. 31: Pressure-sensitive areas ... 65 Fig. 32: iCan™ touchscreen withoutO2/N2gas supply ... 66 Fig. 33: iCan™ touchscreen with combined gas connection ... 66 Fig. 34: Menu structure overview... 67 Fig. 35: Heat-up phase display ... 68 Fig. 36: Setting the temperature set value ... 70 Fig. 37: Setting the CO2 set value... 71 Fig. 38: Setting the O2 set value ... 72 Fig. 39: Activating the auto-start routine... 75 Fig. 40: Interrupting the auto-start routine ... 76 Fig. 41: Changing the code ... 77 Fig. 42: Date / time setting ... 78 Fig. 43: Display contrast setting ... 79 Fig. 44: Key tone setting ... 79 Fig. 45: RS 232 interface baud rate setting ... 80 Fig. 46: USB interface baud rate setting... 80 Fig. 47: Language setting... 81 Fig. 48: Reminder interval setting... 82 Fig. 49: Event display ... 83

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Betriebsanleitung | HERAcell

®

150i / 240i

Figures Fig. 50: Logging cycle setting ... 83 Fig. 51: Error table display ... 84 Fig. 52: Alarm relay setting ... 85 Fig. 53: Low humidity setting ... 86 Fig. 54: Gas tight screen setting ... 87 Fig. 55: Water level setting ... 87 Fig. 56: Alarm relay setting ... 88 Fig. 57: Bottle turning device speed setting... 88 Fig. 58: Switching the O2 control on and off... 89 Fig. 59: Icon description overview ... 90 Fig. 60: Gas monitoring icons... 91 Fig. 61: Enabling/disabling the keypad lock... 92 Fig. 62: Software versions ... 93 Fig. 63: Trend display scaling ... 94 Fig. 64: Event error messages ... 95 Fig. 65: Decontamination routine phases ... 106 Fig. 66: Activating contra-con... 107 Fig. 67: Interrupting / cancelling contra-con ... 108 Fig. 68: contra-con completion... 109 Fig. 69: Preparing the temperature calibration ... 111 Fig. 70: Temperature calibration procedure ... 112 Fig. 71: Preparing CO2 calibration ... 113 Fig. 72: Gas-tight screen measurement opening... 114 Fig. 73: CO2 calibration procedure ... 115 Fig. 74: Gas inlet filter installation... 116 Fig. 75: Device fuse replacement ... 116 Fig. 76: Magnetic door seal replacement... 117

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® Operating Instructions | HERAcell 150i / 240i

1

General notes Overview of the Thermo Fisher international sales organisations Europe, Middle East, Africa

Postal address Germany: Thermo Electron LED GmbH Robert-Bosch-Straße 1 D - 63505 Langenselbold Enquiries from Germany: Phone Sales 0800 1 536376 Phone Service 0800 1 112110 Fax Sales/Service 0800 1 112114 E-Mail [email protected] Enquiries from Europe, Middle East, and Africa: Phone + 49 (0) 6184 / 90-6940 Fax + 49 (0) 6184 / 90-6772 E-Mail [email protected]

America

Postal address USA: Thermo Fisher Scientific 275 Aiken Road Asheville, NC 28804 USA Enquiries from North America: Phone +1 800-879 7767 Fax +1 828-658 0363 E-Mail [email protected] Enquiries from Latin America: Phone +1 828-658 2711 Fax +1 828-645 9466 E-Mail [email protected] Enquiries from Asia Pacific: Phone +852-2711 3910 Fax +852-2711 3858 E-Mail [email protected]

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.1 Identification of the device and of the documentation Identfication data

Identification of the device Device name: Type designation: Serial No.:

CO2 incubator HERAcell® 150i HERAcell® 240i 40830469 or higher

Allocation of product documentation User information: Operating instructions 50113925 D Valid: 08.2009 Certifications and quality audit: Certification: CE Certification Test mark: GS by VDE Germany CSA/UL by VDE Germany

1.2 Instruction of the operating personnel

Target group Process procedures for personnel

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These operating instructions describe the CO2 incubator HERAcell® 150i / 240i. The CO2 incubator has been manufactured in keeping with the latest technological developments and is operationally safe. However, the device may present potential hazards, particularly if it is operated by inadequately trained personnel or if it is not used in accordance with the intended purpose. Therefore, the following must be observed to prevent accidents: • The CO2 incubator must be operated only by trained and authorized personnel. • For any operation of this device, the operator must prepare clear and concise written instructions in the language of the operating and cleaning personnel based on these operating instructions, applicable safety data sheets, plant hygiene guidelines, and technical regulations, in particular: – which decontamination measures are to be applied for the CO2 incubator and accessories, – which protective measures apply when specific agents are used, – which measures are to be taken in the case of an accident. • Repairs to the device must be carried out only by trained and authorized expert personnel.

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.3 Applicability of the instructions

Original document for translation

• The contents of the operating instructions are subject to change without further notice. • Concerning translations into foreign languages, the German version of these operating instructions is binding. • Keep these operating instructions close to the device so that safety instructions and important information are always accessible. Should you encounter problems that are not detailed adequately in these operating instructions, please contact Thermo Scientific immediately for your own safety.

1.4 Warranty Requirements for warranty

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Thermo Scientific warrants the operational safety and functions of the CO2 incubator only under the condition that: • the device is operated and serviced exclusively in accordance with its intended purpose and as described in these operating instructions, • the device is not modified, • only original spare parts and accessories that have been approved by Thermo Fisher Scientific are used, • inspections and maintenance are performed at the specified intervals. The warranty is valid from the date of delivery of the device to the operator.

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.5 Explanation of safety information and symbols 1.5.1 Safety information and symbols used in the operating instructions WARNING: Personal injuries

Indicates a hazardous situation which, if not avoided, could result in death or serious injuries. CAUTION: Personal injuries

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injuries. NOTICE: Property damage

Indicates a situation which, if not avoided, could result in property damage. NOTE: Useful information

Is used for applicational hints and useful information.

1.5.2 Additional symbols for safety informations: Wear safety gloves!

Wear safety goggles!

Harmful liquids!

Electric shock!

Hot surfaces!

Fire hazard!

Explosion hazard!

Suffocation hazard!

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.5.3 Symbols on the device

CE conformity mark: confirms conformity according to EU Guidelines

H

VDE test mark

Mark of conformity USA/Canada

Observe operating instructions!

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.6 Intended purpose of the device Use

1.6.1 Correct use The CO2 incubator HERAcell® 150i / 240i is a laboratory device for preparing and cultivating cell and tissue cultures. The device allows the simulation of the special physiological ambient conditions for these cultures due to the exact control of: • temperature, • CO2 content, • O2/N2 content, • and increased relative humidity.

Fields of application

HERAcell® 150i / 240i has been designed for installation and operation in the following fields of application: • Laboratories for cytobiological and biotechnological experiments of safety levels L1, L2, and L3. • Medical-microbiological laboratories in accordance with DIN 58 956. • Laboratories in the central area of clinics and hospitals.

Gas supply system

The gases required for the incubator (CO2 and / or O2/N2) are supplied to the device from a separate gas supply system, either from gas cylinders or from a central pressurized gas container. The layout of the gas supply system must ensure that the operating pressure of the gas supply lines can be set to a range between 0.8 bar (min.) to 1 bar (max.) and that the pressure cannot be changed. If the device is equipped with the optional gas monitoring system, up to four devices can be interconnected in line, independent of the of the gas supply system capacity. The CO2 incubator is suitable for continuous operation.

Incorrect use

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1.6.2 Incorrect use Do not use cell or tissue cultures in the device that are not in accordance with the regulations of safety levels L1, L2, and L3. Do not use tissues, substances or liquids that: • are easily ignitible or explosive, • release vapors that form combustible or explosive mixtures when exposed to air, • release poisons.

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.7 Standards and directives The device complies with the following standards and guidelines: • DIN EN 61010 - 1: 2002, DIN EN 61010 - 2 - 010 : 2004 • Low Voltage Guideline 2006/95/EG • EMC Guideline 2004/108/EG • UVV BGV D4 Revised Version (UVV VBG 20, continues to be valid for old stock) The following safety regulations must be observed if the device is operated within the territory of the Federal Republic of Germany: • BGR 104 • BGR 120 • BGI 629 • BGI 630 • TRG 280 • EC Official Gazette, L 374 • Safety data sheets of the gas suppliers with regard to the particular characteristics of CO2, O2, and N2. • Principles of good microbiological proceedings, notice of the trade association of the German chemical industry. For other countries, the applicable national regulations are binding.

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® Operating Instructions | HERAcell 150i / 240i

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General notes 1.8 Safety notes on gases

Installation work: Any work to supply lines and pressurized gas containers, cylinders or containers used for storing CO2 or O2/N2 must only be carried out by expert personnel using the appropriate tools.

Instruction of the personnel: Personnel operating devices with CO2 supply must be instructed about the particularities in the handling of CO2 before starting their work: • Correct operation of pressurized gas containers and gas supply systems, • obligation to report damages and shortcomings in CO2 supply lines, • measures to be taken in case of accidents or failures. These instructions must be repeated at appropriate intervals and must comprise the particular operating instructions of the gas supplier.

Carbon dioxide

1.8.1 Safety notes on carbon dioxide (CO2) Since CO2 is rated as a harmful gas, certain safety instructions must be observed when the CO2 incubator is started up and when the device is operated.

Suffocation hazard! Large amounts of CO2 released into the room atmosphere may cause suffocation. If CO2 is released, initiate safety measures immediately! • Leave the room immediately and do not allow others to enter the room! • Inform security service or fire department!

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® Operating Instructions | HERAcell 150i / 240i

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General notes

Oxygen

1.8.2 Safety notes on oxygen (O 2) O2 is a gas that promotes combustion and may explode in combination with grease-containing materials.

Oxygen explosion! O2 may explode in combination with oils, greases, and lubricants. If highly compressed oxygen comes in contact with grease- or oil-containing substances, the mixture may explode! • For cleaning these device components, use only oil- and grease-free lubricants. • Keep all connections and components of the oxygen system free from substances that contain oil, grease, or lubricant! Fire hazard! Released oxygen promotes combustion. Do not use open flames in the vicinity of oxygen-operated systems! • Do not smoke in the vicinity of oxygen systems. • Do not expose the components of an oxygen system to excessive heat.

Nitrogen

1.8.3 Safety notes on nitrogen (N 2) Nitrogen mixes easily with air. High concentrations of nitrogen reduce the oxygen content in the air.

Suffocation hazard! Large amounts of N2 released into the room atmosphere may cause suffocation. If N2 is released, initiate safety measures immediately! • Leave the room immediately and do not allow others to enter the room! • Inform security service or fire department!

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® Operating Instructions | HERAcell 150i / 240i

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Delivery of the device 2.1 Packaging

Packaging materials

The CO2 incubator HERAcell® 150i / 240i is delivered in a stable packaging box. All packaging materials can be separated and are reusable: • Packaging carton: Recycled paper • Foam elements: Styrofoam (CFC-free) • Pallet: Untreated wood • Packaging film: Polyethylene • Packaging ribbons: Polypropylene

2.2 Acceptance inspection After the device has been delivered, check the delivery immediately for: • completeness, • possible damage. Damage report

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If components are missing or damage is found on the device or the packaging, esp. damages caused by humidity and water, please contact the linehauler as well as the Technical Support of Thermo Scientific immediately.

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® Operating Instructions | HERAcell 150i / 240i

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Delivery of the device

2.3 Standard equipment components HERAcell® 150i

Quantity of the delivered components (in piece)

HERAcell® 150i CO2 incubator or CO2/O2 incubator Solid glass door and continuous shelves

3-door gas tight screen and continuous shelves

Shelf

3

3

Support rail for shelf

4

4

Shelf supports for shelf

6

6

Insert for pressure compensation opening

1

1

Plug for pipe channel

1

1

Power supply cable

1

1

Connector, potential-free contact

1

1

Spare caps, set

1

1

CO2 connecting hose set

1

1

Open-end wrench, 24 mm

1

1

Allen wrench 2 mm for blower wheel

1

1

Allen wrench 3 mm for blower wheel cover

1

1

Operating instructions (CD)

1

1

Water pump

1

1

2.4 Optional equipment components HERAcell® 150i

Quantity of the delivered components (in piece)

HERAcell® 150i CO2 incubator or CO2/O2 incubator Solid glass door and continuous shelves

3-door gas tight screen and continuous shelves

O2 connecting hose set

1

1

O2 sensor with set for gas humidification *1)

1

1

CO2 connecting hose set, gas monitoring (optional)

1

1

O2 / N2 connecting hose set, gas monitoring (optional)

1

1

*1) O2 sensor with gas humidification set is packed in a separate carton and placed into the work space during transport.

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® Operating Instructions | HERAcell 150i / 240i

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Delivery of the device

2.5 Standard equipment components HERAcell® 240i

Quantity of the delivered components (in piece)

Solid glass door and continuous shelves (standard version)

HERAcell® 240i CO2 incubator or CO2/O2 incubator Solid glass door 6-door gas tight and split shelves screen and (optional) continuous shelves (standard version)

6-door gas tight screen and split shelves (optional)

Shelf

3

6

3

6

Support rail for shelf

4

6

4

6

Shelf supports for shelf

6

12

6

12

Insert for pressure compensation opening

1

1

1

1

Plug for pipe channel

1

1

1

1

Power supply cable

1

1

1

1

Connector, potential-free contact

1

1

1

1

Spare caps, set

1

1

1

1

CO2 connecting hose set

1

1

1

1

Open-end wrench, 24 mm

1

1

1

1

Allen wrench 2 mm for blower wheel

1

1

1

1

Allen wrench 3 mm for blower wheel cover

1

1

1

1

Operating instructions (CD)

1

1

1

1

Water pump

1

1

1

1

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