HERAcell VIOS 160i and 250i CO2 Incubator User Manual July 2015

©

2015 Thermo Fisher Scientific Inc. All rights reserved.

Trademarks HERACELL VIOS™, Steri-run™, Steri-cycle™, iCan™ and THRIVE™ are registered trademarks of Thermo Scientific. Thermo Scientific is a brand of Thermo Fisher Scientific Inc. All other 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

Thermo Fisher Scientific Inc. provides this document to its customers with a product purchase to use in the product operation. This document is copyright protected and any reproduction of the whole or any part of this document is strictly prohibited, except with the written authorization of Thermo Fisher Scientific Inc. The contents of this document are subject to change without notice. All technical information in this document is for reference purposes only. System configurations and specifications in this document supersede all previous information received by the purchaser. Thermo Fisher Scientific Inc. makes no representations that this document is complete, accurate or error-free and assumes no responsibility and will not be liable for any errors, omissions, damage or loss that might result from any use of this document, even if the information in the document is followed properly. This document is not part of any sales contract between Thermo Fisher Scientific Inc. and a purchaser. This document shall in no way govern or modify any Terms and Conditions of Sale, which Terms and Conditions of Sale shall govern all conflicting information between the two documents.

T Table of Contents Preface

... 1 General notes...1 Identification of the device and of the documentation ...1 Identification of the device ...1 Instruction of the operating personnel ...1 Applicability of the instructions ...2 Original document for translation ...2 Warranty ...2 Requirements for warranty ...2 Explanation of safety information and symbols...3 Safety information and symbols used in the operating instructions ...3 Additional symbols for safety informations: ...4 Symbols on the device ...5 Intended purpose of the device ...5 Correct use ...5 Incorrect use ...6 Standards and directives ...6 Safety notes on gases ...7 Instruction of the personnel: ...7 Safety notes on carbon dioxide (CO2) ...7 Safety notes on oxygen (O2) ...8 Safety notes on nitrogen (N2) ...8

Chapter 1 Delivery of the Incubator ... 1-1 Packaging ... 1-1 Acceptance inspection... 1-1 Standard equipment components HERACELL VIOS 160i / 250i... 1-2 Optional equipment components HERACELL VIOS 160i / 250i ... 1-2 Optional equipment components HERACELL VIOS 160i... 1-2 Optional equipment components HERACELL VIOS 250i... 1-3 Chapter 2 Installation of the device ... 2-1 Environmental Conditions ... 2-1 Requirements: ... 2-1 Room ventilation... 2-2 Space requirements ... 2-2 Transport ... 2-3 Stacking... 2-3 Retrofitting/Modifications... 2-6

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Chapter 3 Description of the device ... 3-1 HERACELL VIOS 160i / VIOS 250i Front view ... 3-2 HERACELL VIOS 160i / VIOS 250i Rear view ... 3-4 Looped-through gas supply at HERACELL VIOS 160i / HERACELL VIOS 250i: ... 3-5 Safety devices HERACELL VIOS 160i / VIOS 250i... 3-6 Workspace atmosphere ... 3-6 Temperature: ... 3-6 Relative humidity: ... 3-7 Water quality recommendations: ... 3-7 Prefilter ... 3-7 HEPA-filter and air duct ... 3-8 CO2 supply: ... 3-9 O2 supply: ... 3-9 N2 supply: ... 3-10 Door switch... 3-10 Sensor system ... 3-11 Supply interface... 3-13 Standard interfaces ... 3-13 Optional interfaces ... 3-14 Gas connection: ... 3-15 Label: ... 3-15 USB interface: ... 3-15 4-20 mA interface: ... 3-15 Alarm contact: ... 3-16 Power supply connection: ... 3-16 Workspace Components... 3-17 Interior container ... 3-17 Glass door and optional gas-tight screen ... 3-17 Water reservoir ... 3-19 Heating system ... 3-21 Rear panel openings ... 3-21 Shelf system ... 3-22 Chapter 4 Start-up ... 4-1 Adapting the unit to the ambient atmosphere... 4-1 Preparing the workspace ... 4-1 Installing the “MAX” fill level indicator and the pre-filter ... 4-2 Install the air duct... 4-4 Installing the HEPA-filter and the water reservoir cover panel ... 4-5 Installing the shelf system ... 4-7 Installation/removal of the support rail ... 4-7 Shelf support installation ... 4-8 Levelling the device ... 4-8 Mount the split inserts (optional) into the HERACELL VIOS 250i... 4-9 Gas connection... 4-10 Installing gas pressure hoses ... 4-10 Gas connection without gas monitoring system ... 4-11 CO2 connection with gas monitoring system (optional) ... 4-12 Combined CO2 and O2/N2 connection with gas monitoring system (optional) ... 4-13

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Power supply connection ... 4-15 Connecting the USB interface: ... 4-16 Connecting the alarm contact: ... 4-16 Connecting the 4-20 mA interface:... 4-18 Chapter 5 Operation ... 5-1 Preparing the device... 5-1 Starting operation ... 5-3 Chapter 6 Handling and control ... 6-1 Power switch... 6-2 Operating panel and operating structure... 6-3 Versions without O2/N2 control ... 6-4 Version with combined CO2/O2/N2 control (optional) ... 6-5 Structure of the operating levels ... 6-5 Factory presettings of the iCan™ Touchscreen controls ... 6-7 Heat-up phase of the control loop sensors... 6-7 Behavior of keys during adjustments... 6-8 Setting the temperature set value... 6-8 Setting the CO2 set value ... 6-9 Setting the O2 set value ... 6-10 auto-start function ... 6-12 Activating the auto-start routine ... 6-14 Interrupting the auto-start routine ... 6-15 Launching steri-run ... 6-16 User configuration ... 6-17 Settings / Setup ... 6-17 Data Logging ... 6-27 Options ... 6-31 Icon description ... 6-40 Enabling/disabling the keypad lock ... 6-42 Software versions ... 6-43 Trend display scaling ... 6-43 Error messages ... 6-45 Response to an error message event ... 6-45 Resetting overtemperature protection ... 6-46 Measures after power outage ... 6-47 Troubleshooting ... 6-48 Chapter 7 Shut-down ... 7-1 Shutting the device down... 7-1 Chapter 8 Cleaning and disinfection... 8-1 Cleaning, ... 8-1 Decontamination procedures ... 8-2 Preparing for disinfection or steri-run ... 8-2 Wipe/spray disinfection ... 8-3 Steri-run decontamination routine... 8-7 Activating steri-run ... 8-9

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cancel steri-run ... 8-10 Steri-run interruption due to error ... 8-11 Completing steri-run ... 8-12 Chapter 9 Maintenance ... 9-1 Inspections and checks... 9-1 Service Intervals... 9-2 Preparing Temperature Calibration ... 9-2 Temperature Calibration Procedure ... 9-3 Preparing the CO2 calibration... 9-5 CO2 calibration procedure ... 9-6 Replacing the HEPA-filter ... 9-7 Replacing the gas inlet filter... 9-9 Device fusing replacement ... 9-10 Replacing the Door Seal ... 9-11 Chapter 10 Waste disposal ... 10-1 Overview of the materials used: ... 10-1 Chapter 11 Specifications ... 11-1 HERACELL VIOS 160i ... 11-2 HERACELL VIOS 160i ... 11-4 HERACELL VIOS 250i ... 11-6 HERACELL VIOS 250i ... 11-8 Chapter 12 Annex: Data communication... 12-1 USB interface ... 12-1 Installing the USB port driver ... 12-2 Structure of the command sequences for data communication... 12-4 Description of protocol ... 12-4 Overview of general parameters (addresses 0xxx) ... 12-5 Reading general parameters ... 12-5 Overview of incubator parameters (addresses 2xxx)... 12-5 Reading basic parameters ... 12-6 Reading internal function parameters ... 12-7 Error memory structure ... 12-8 Error memory data set structure scheme: ... 12-9 Overview of the possible error messages in hex coding ... 12-10 Overview of the possible error messages in bit coding General device status, temperature and CO2 control loop: ... 12-10 O2 control loop and water level: ... 12-11 Data logger structure ... 12-11 Data logger data set structure scheme: ... 12-13 Overview of possible event entries in bit coding Overview of event entries, Part I: ... 12-14 Overview of event entries, Part II: ... 12-15 Examples of data logger codes... 12-15 Functions for data logger queries ... 12-16 Example of a code for a a data logger query ... 12-16

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Program HERACELL VIOS 160i / HERACELL VIOS 250i... 12-21 Installing the HERACELL VIOS 160i & HERACELL VIOS 250i ... 12-22 Operating the HERACELL VIOS 160i & HERACELL VIOS 250i ... 12-23 Chapter 13 Device log ... 13-1 Chapter 14 Contact Information Thermo Scientific ... 14-1

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F Figures Figure 2-1. Device dimensions ...2-2 Figure 2-2. Lift points ...2-3 Figure 2-3. Stacking ...2-4 Figure 2-4. Stacking adapter and base rack with stacking elements...2-5 Figure 2-5. Fastening the adapter plate to the lower unit...2-5 Figure 3-1. HERA CELL VIOS 160i / VIOS 250i Front view...3-2 Figure 3-2. HERACELL VIOS 160i / VIOS 250i Rear view ...3-4 Figure 3-3. Looped-through gas supply HERACELL VIOS 160i / HERACELL VIOS 250i ...3-5 Figure 3-4. HEPA-filter and airbox ...3-8 Figure 3-5. Air duct...3-9 Figure 3-6. Door switch ...3-10 Figure 3-7. Temperature, O2, CO2 and humidity sensors ...3-11 Figure 3-8. Sensors for water level ...3-12 Figure 3-9. Interfaces (right side of control box)...3-13 Figure 3-10. Optional interfaces (left side of control box) ...3-14 Figure 3-11. HERACELL VIOS 160i with glass door...3-18 Figure 3-12. HERACELL VIOS 160i with threefold gas-tight screen ...3-19 Figure 3-13. Water reservoir...3-20 Figure 3-14. Drain valve of water reservoir...3-20 Figure 3-15. Rear panel openings ...3-21 Figure 3-16. Shelf system components ...3-22 Figure 4-1. “MAX” fill level indicator ...4-2 Figure 4-2. „MAX“ fill level indicator and pre-filter ...4-3 Figure 4-3. Assembling the air duct...4-4 Figure 4-4. Assembling the HEPA-filter and the airbox...4-5 Figure 4-5. Place the airbox onto the Water reservoir cover panel...4-6 Figure 4-6. Installing the airbox ...4-6 Figure 4-7. Support rail installation/removal ...4-7 Figure 4-8. Shelf support installation...4-8 Figure 4-9. Installation of split inserts ...4-9 Figure 4-10. Installing gas pressure hoses...4-10 Figure 4-11. Gas connection without gas monitoring system ...4-11 Figure 4-12. CO2 connection with gas monitoring system (optional) ...4-12 Thermo Scientific

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Figure 4-13. Combined CO2/O2/N2 connection with gas monitoring system (optional)...4-13 Figure 4-14. Power supply connection ...4-15 Figure 4-15. Connection example alarm contact ...4-17 Figure 4-16. Pin-out of the 4-20 mA interface ...4-18 Figure 5-1. Water reservoir...5-3 Figure 5-2. “MAX” fill level indicator ...5-4 Figure 6-1. Power switch...6-2 Figure 6-2. Main screen: Touch-sensitive screen areas ...6-3 Figure 6-3. iCan™ Touchscreen without O2/N2 gas supply ...6-4 Figure 6-4. iCan™ Touchscreen with combined gas connection...6-5 Figure 6-5. Menu structure overview...6-6 Figure 6-6. Heat-up phase display ...6-7 Figure 6-7. Temperature display field and temperature selection menu ...6-8 Figure 6-8. Setting the temperature set value...6-9 Figure 6-9. CO2 display and CO2 menu ...6-9 Figure 6-10. Setting the CO2 set value...6-10 Figure 6-11. O2 display and O2 menu...6-11 Figure 6-12. Setting the O2 set value ...6-11 Figure 6-13. Activating the auto-start routine...6-14 Figure 6-14. auto-start-status display window ...6-15 Figure 6-15. Interrupting the auto-start routine ...6-16 Figure 6-16. Error message subsequent to aborted auto-start...6-16 Figure 6-17. User configuration menu ...6-17 Figure 6-18. Settings/Setup menu ...6-18 Figure 6-19. Changing the keypad lock code...6-18 Figure 6-20. Changing the keypad lock code...6-19 Figure 6-21. Date/Time menu ...6-20 Figure 6-22. Setting the date ...6-20 Figure 6-23. Setting the time...6-21 Figure 6-24. Adjusting display brightness...6-22 Figure 6-25. Adjusting key tone volume...6-23 Figure 6-26. Interface USB menu...6-24 Figure 6-27. USB interface baud rate setting ...6-24 Figure 6-28. Language setting ...6-25 Figure 6-29. Choose the desired reminder interval function. ...6-26 Figure 6-30. Setting the reminder interval for steri-run ...6-27 Figure 6-31. Event logging menu ...6-28 Figure 6-32. Event display...6-28 Figure 6-33. Logging cycle setting ...6-29 Figure 6-34. Displaying the error table...6-31

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Figure 6-35. Options menu... 6-32 Figure 6-36. Alarm menu ... 6-32 Figure 6-37. Alarm relay setting... 6-33 Figure 6-38. Low humidity setting ... 6-34 Figure 6-39. Gas tight screen setting... 6-35 Figure 6-40. Setting the water level sensor ... 6-36 Figure 6-41. Alarm relay setting... 6-37 Figure 6-42. Switching the O2 control on and off... 6-38 Figure 6-43. HEPA configuration ... 6-39 Figure 6-44. Activating / de-activating the HEPA-filter... 6-39 Figure 6-45. Icon description ... 6-40 Figure 6-46. Gas monitoring icons ... 6-41 Figure 6-47. Enabling/disabling the keypad lock ... 6-43 Figure 6-48. Software versions... 6-43 Figure 6-49. Invoking the CO2 concentration graph display... 6-44 Figure 6-50. Invoking the CO2 concentration graph display... 6-44 Figure 6-51. Event error messages... 6-46 Figure 6-52. Failure message Overtemperature ... 6-46 Figure 6-53. Failure message Overtemperature ... 6-47 Figure 7-1. Drain valve of water reservoir ... 7-1 Figure 8-1. Drain valve of water reservoir ... 8-2 Figure 8-2. HEPA-filter and airbox ... 8-5 Figure 8-3. Air duct... 8-6 Figure 8-4. Decontamination routine phases ... 8-9 Figure 8-5. steri-run menu - Progress ... 8-9 Figure 8-6. activate steri-run... 8-10 Figure 8-7. Interrupting / cancelling steri-run... 8-11 Figure 8-8. To stop steri-run ... 8-12 Figure 9-1. Preparing Temperature Calibration... 9-3 Figure 9-2. Temperature display field and temperature selection menu ... 9-4 Figure 9-3. Temperature Calibration Procedure ... 9-4 Figure 9-4. Gas-tight screen measurement opening ... 9-6 Figure 9-5. CO2 calibration procedure... 9-7 Figure 9-6. Removing the airbox ... 9-8 Figure 9-7. Installing the HEPA-filter ... 9-9 Figure 9-8. Gas inlet filter installation ... 9-10

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P Preface General notes Identification of the device and of the documentation Identification of the device Identification data Device name: Type designation:

CO2 incubator HERACELL VIOS 160i HERACELL VIOS 250i

Allocation of product documentation Documents CD-ROM 50143971 Certifications and quality audit: Certification: CE Certification Test mark: TÜV GS, cCSAus, EAC

Instruction of the operating personnel These operating instructions describe the CO2 incubator HERACELL VIOS 160i / HERACELL VIOS 250i. 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 device 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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Preface Applicability of the instructions

Applicability of the instructions Original document for translation • The contents of the operating instructions are subject to change without further notice. • In case of conflicting translations into foreign languages the German-language version of these operating instructions shall be 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.

Warranty Requirements for warranty 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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Preface Explanation of safety information and symbols

Explanation of safety information and symbols Safety information and symbols used in the operating instructions WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injuries.

CAUTION Indicates a hazardous situation which, if not avoided, could result in minor or moderate injuries.

CAUTION Indicates a situation which, if not avoided, could result in property damage.

Note Is used for application al hints and useful information.

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Preface Explanation of safety information and symbols

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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Preface Intended purpose of the device

Symbols on the device CE conformity mark: confirms conformity according to EU Guidelines

TÜV-tested safety

Mark of conformity USA/Canada

EAC conformity mark: confirms conformity according to all technical regulations of the Eurasian customs union (Russia, Kazakhstan and Belarus)

Observe operating instructions!

Hot surfaces!

Intended purpose of the device Correct use This CO 2 incubator is designed for preparing and cultivating cell cultures, but it is not to be used for medical applications or for in-vitro-diagnostics. To that end, a controlled set of physiological ambient conditions is produced in the workspace of the device by exerting precise control of the following parameters: • Temperature • CO2 content • O2/N2 content • Relative humidity

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Preface Standards and directives

Typically, this CO2 incubator has been designed for being installed and operated in the following areas: • Laboratories for cytobiological and biotechnological experiments of safety levels L1, L2, and L3 • Medical-microbiological laboratories in accordance with DIN EN 12128 • Research labs in clinics and hospitals This device is intended for professional use only and must only be operated by trained staff.

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 ignitable or explosive, • release vapors that form combustible or explosive mixtures when exposed to air, • release poisons.

Standards and directives The device complies with the following standards and guidelines: • Low Voltage Directive 2006/95/EC • IEC 61010-1:2010+Corr. 2011, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements • IEC 61010-2-010:2003, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of material • EMC Directive 2004/108/EC • IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use - EMC requirements, Part 1: General requirements • FCC 47, Part 15, § 15.107, Measurement 2015, EMC regulation FCC • FCC 47. Part 15, § 15.109, Measurement 2015, EMC regulation FCC For other countries, the applicable national regulations are binding.

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Preface Safety notes on gases

Safety notes on gases Note Installation work: Any work on 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.

Note It must be ensured that the exposure limits at work place for CO2 and/or O2/N2 are not exceeded. For the Federal Republic of Germany the TRGS 900 should be observed; other countries may have different limit values. The country-specific national exposure limits at work place shall be met.

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.

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 carbon dioxide (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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Preface Safety notes on gases

Safety notes on oxygen (O2) O2 is a gas that promotes combustion and may explode in combination with grease-containing materials. Oxygen explosion! Oxygen (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! Control panel and display window protective foil! • 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 (O2) 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.

Safety notes on nitrogen (N2) Nitrogen mixes easily with air. High concentrations of nitrogen reduce the oxygen content in the air. Suffocation hazard! Large amounts of nitrogen (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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