Summary of Contents for cytiva LM500JRMA-SMC
- Page 1 Stainless steel mixer tank For use with LevMixer™ and Magnetic Mixer single-use mixing systems Operating Instructions Original instructions cytiva.com...
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Page 2: Table Of Contents
Table of Contents Table of Contents Introduction ............................3 Important user information ................................4 About this manual ....................................5 Associated documentation ................................6 Safety instructions ..........................7 Safety precautions ....................................8 Labels and symbols ....................................12 System description ..........................13 Installation ............................ -
Page 3: Introduction
1 Introduction 1 Introduction About this chapter This chapter contains information about this manual and associated user documentation, important user information, and intended use of the product. In this chapter Section See page Important user information About this manual Associated documentation Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 4: Important User Information
1 Introduction 1.1 Important user information 1.1 Important user information Introduction This section contains important user information about the product and this manual. Read this before operating the product All users must read the entire Operating Instructions before installing, operating, or main- taining the product. -
Page 5: About This Manual
1 Introduction 1.2 About this manual 1.2 About this manual Introduction This section contains information about the purpose and scope of this manual, notes and tips, and typographical conventions. Purpose of this manual This manual provides information needed to install, operate, and perform maintenance in a safe way. Scope of this manual The following Operating Instructions contains all essential information for the user to install and make use of single-use mixing biocontainers with capacities of 500 L, 1000 L, 2000 L, and 2500 L in... -
Page 6: Associated Documentation
Cytiva. Access user documentation online Scan the QR code or visit cytiva.com/instructions. Enter the title or the document number to access the file. Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 7: Safety Instructions
2 Safety instructions 2 Safety instructions About this chapter This chapter describes safety precautions, labels, and symbols. In this chapter Section See page Safety precautions Labels and symbols Important WARNING All users must read and understand the entire contents of this general safety chapter, and the specific safety precau- tions information in each subsequent chapter of this manual to become aware of the hazards involved. -
Page 8: Safety Precautions
2 Safety instructions 2.1 Safety precautions 2.1 Safety precautions Introduction Stainless steel mixer tank is powered by mains voltage and handles materials that can be hazardous. Before installation, operation, or maintenance, you must be aware of the hazards described in this manual. - Page 9 2 Safety instructions 2.1 Safety precautions WARNING Do not use this equipment in any manner inconsistent with these operating instructions or under any conditions that exceed the environmental specifications stated. WARNING Each Allegro LevMixer and Magnetic Mixer biocontainer contains a magnetic impeller, which is a source of a strong magnetic field within close proximity (12 inches or 30 centimeters) of the impeller.
- Page 10 WARNING Risk of getting locked inside of tank. Follow the organizational confined space entry procedure. CAUTION For technical assistance contact the sales organization from which you purchased the product or Cytiva directly. Stainless steel mixer tank Operating Instructions USD3194 AA...
- Page 11 2 Safety instructions 2.1 Safety precautions CAUTION Do not attempt to move the tank with only one person. CAUTION Risk of pinching fingers. NOTICE If the unit is transported or stored at temperatures colder than the operating environment, it is necessary to wait 1 to 2 hours to equalize the internal temperatures of the unit before powering on.
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Page 12: Labels And Symbols
2 Safety instructions 2.2 Labels and symbols 2.2 Labels and symbols Introduction This section describes the nameplate, labels, and other safety and regulatory labels and symbols. Nameplate The nameplate provides information about the model, manufacturer, and technical data. Other labels The following labels may be present on the Stainless steel mixer tank: Label Description... -
Page 13: System Description
These tanks are not designed to be compatible with other mixing technologies nor with biocon- tainers supplied by other manufacturers. Modification of these tanks without prior authorization from Cytiva will immediately void the warranty. Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 14: Installation
4 Installation 4 Installation About this chapter This chapter provides required information to enable users and service personnel to unpack and install the Stainless steel mixer tank. In this chapter Section See page Unpacking Setting up for first time use Mixing biocontainer installation Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 15: Unpacking
4 Installation 4.1 Unpacking 4.1 Unpacking The tank ships in a wooden crate. The following steps describe how to unpack the Stainless steel mixer tank: Step Action Carefully open the crate. Unlock the wheel brakes. Wheel the tank out of the crate and move it to the designated working location. The crate must be retained for use in the event that the tank has to be shipped in the future. -
Page 16: Setting Up For First Time Use
4 Installation 4.2 Setting up for first time use 4.2 Setting up for first time use CAUTION Take care to avoid trapped fingers when preparing load cells for use. Note: The actual load cell and mounting kit design and orientation may vary from those shown. Consult the documentation provided with your tank for details of your particular configura- tion. - Page 17 4 Installation 4.2 Setting up for first time use Step Action Use a wrench, size M24, to fully retract the jack bolt. Figure 4.2: Jack bolt adjustment (as seen upwards) Confirm that, after retraction, there is a visible gap between the head of the jack bolt and the opposing mounting plate and that the load cell sits securely in its recess without any looseness or play, as shown in the images below.
- Page 18 4 Installation 4.2 Setting up for first time use Step Action Figure 4.4: Section view of locked position for transport Figure 4.5: Section view of open position for use Verify by hand that each anti-liftoff plate, shown in the image below (1), and rod end bear- ings (heim and rose joint, 2) move freely.
- Page 19 Each load cell is supplied pre-calibrated with a certificate. Following installation, calibration must be confirmed or repeated according to user organization requirements. Repeat calibration service is available directly from the load cell supplier. Contact Cytiva for details. Stainless steel mixer tank Operating Instructions USD3194 AA...
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Page 20: Mixing Biocontainer Installation
4 Installation 4.3 Mixing biocontainer installation 4.3 Mixing biocontainer installation Note: The procedure described below is intended for LevMixer and Magnetic Mixer single-use mixing systems and mixing biocontainers only. In this section Section See page 4.3.1 Preparing the mixing tank 4.3.2 Installing the mixing biocontainer 4.3.3... -
Page 21: Preparing The Mixing Tank
4 Installation 4.3 Mixing biocontainer installation 4.3.1 Preparing the mixing tank 4.3.1 Preparing the mixing tank Follow the steps below to prepare the mixing tank. Step Action Prior to Allegro mixing biocontainer installation, inspect the mixing biocontainer contact surfaces of the tank to make sure that they are clean, dry and free from material or defects that might damage the Allegro mixing biocontainer film. - Page 22 4 Installation 4.3 Mixing biocontainer installation 4.3.1 Preparing the mixing tank Step Action Make sure that the interface is fully engaged in the drive port and that the o-ring is completely installed in the corresponding o-ring channel on the side of the interface, as shown in the image below.
- Page 23 4 Installation 4.3 Mixing biocontainer installation 4.3.1 Preparing the mixing tank Step Action Assemble the clamp and aligner as shown in the image below. Figure 4.13: Magnetic clamp assembled with centering aligner Stainless steel mixer tank Operating Instructions USD3194 AA...
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Page 24: Installing The Mixing Biocontainer
If any such imperfections are discovered, contact Cytiva for advice on whether the Allegro mixing biocontainer can be used. Stainless steel mixer tank Operating Instructions USD3194 AA... - Page 25 4 Installation 4.3 Mixing biocontainer installation 4.3.2 Installing the mixing biocontainer Step Action Note: White creases that are not sharp to the touch are typically not a cause for concern. A blue shipping disc is magnetically attached to the outside of the mixing biocontainer, over the impeller seat.
- Page 26 4 Installation 4.3 Mixing biocontainer installation 4.3.2 Installing the mixing biocontainer Step Action b. Move the hoist to its highest position by operating the crank handle. c. Use the knob to increase the friction of the hoist pulley assembly in the final position. d.
- Page 27 4 Installation 4.3 Mixing biocontainer installation 4.3.2 Installing the mixing biocontainer Step Action Pull the hoist indexing plunger, shown in the image below, and lock it in open position by rotating it approximately 30°. a. Reduce the friction of the hoist pulley assembly by turning the knob anti-clockwise. b.
- Page 28 4 Installation 4.3 Mixing biocontainer installation 4.3.2 Installing the mixing biocontainer Step Action By operating the hoist crank handle, elevate the bag up to the highest position. In order to avoid damage of the biocontainer or the hoist, do not use excessive force to move the biocontainer up.
- Page 29 4 Installation 4.3 Mixing biocontainer installation 4.3.2 Installing the mixing biocontainer Step Action Locate the bottom drain hose and pass it through the drain port cutout of the tank. Posi- tion the biocontainer so that the center point of the “K-weld”, shown in the image below, is aligned with the center of the tank.
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Page 30: Finishing The Mixing Biocontainer Installation
4 Installation 4.3 Mixing biocontainer installation 4.3.3 Finishing the mixing biocontainer installation 4.3.3 Finishing the mixing biocontainer installation Follow the steps below Step Action If the Allegro mixing biocontainer incorporates an EZ Drain fitment, position it in the drain port cutout, and then snap the EZ Drain clip over the fitment outside the tank as shown in the images below. - Page 31 4 Installation 4.3 Mixing biocontainer installation 4.3.3 Finishing the mixing biocontainer installation Step Action a. Push collar up to unlock. Figure 4.28: Moving from open to closed (stops fluid flow), step 1 b. Pull EZD port down to close drain. Figure 4.29: Moving from open to closed (stops fluid flow), step 2 c.
- Page 32 4 Installation 4.3 Mixing biocontainer installation 4.3.3 Finishing the mixing biocontainer installation Step Action Optional: Prior to filling with liquid, an inert gas or air may be introduced through one of the top ports to pre-inflate the Allegro mixing biocontainer. Pre-inflation for a contained or sterile application must be done only via a sterilizing-grade vent filter integral to the mixing biocontainer.
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Page 33: Filling The Mixing Biocontainer
4 Installation 4.3 Mixing biocontainer installation 4.3.4 Filling the mixing biocontainer 4.3.4 Filling the mixing biocontainer Follow the steps below to fill the mixing biocontainer. Step Action Start filling the Allegro mixing biocontainer per process requirements. If the Allegro mixing biocontainer has been pre-inflated with gas or air, make sure that at least one top port is open to act as a vent for the displaced air to avoid the risk of over- pressurization. - Page 34 4 Installation 4.3 Mixing biocontainer installation 4.3.4 Filling the mixing biocontainer Once filled, the tank must not be moved, and all four wheels must be in contact with the floor. For drainage and disposal guidelines, refer to: • Section 5.2 Mixing biocontainer drainage, on page 38 •...
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Page 35: Operation
5 Operation 5 Operation About this chapter This chapter gives instructions on how to operate Stainless steel mixer tank in a safe way. In this chapter Section See page Docking of the drive unit to the tanks and biocontainer Mixing biocontainer drainage Disposal Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 36: Docking Of The Drive Unit To The Tanks And Biocontainer
5 Operation 5.1 Docking of the drive unit to the tanks and biocontainer 5.1 Docking of the drive unit to the tanks and biocontainer Coupling of the drive unit to the tank must be performed only when the installed Allegro mixing biocontainer is filled with fluid to at least the minimum working volume. - Page 37 5 Operation 5.1 Docking of the drive unit to the tanks and biocontainer Step Action Remove the magnetic clamp, as shown in the image below, from the Allegro mixing biocontainer tank assembly before coupling the drive. To remove the magnetic clamp, reach underneath the drive port and carefully pull the magnetic clamp downwards until it is free from the Allegro mixing biocontainer-tank assembly.
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Page 38: Mixing Biocontainer Drainage
5 Operation 5.2 Mixing biocontainer drainage 5.2 Mixing biocontainer drainage After the mixing process is completed, the Allegro mixing biocontainer’s contents can be drained. The following general guidelines apply and must be used in conjunction with all safety and environ- mental regulations appropriate for the process and location. -
Page 39: Disposal
5 Operation 5.3 Disposal 5.3 Disposal After the mixing process is completed and the Allegro mixing biocontainer’s contents have been drained, the empty Allegro mixing biocontainer can be responsibly disposed of. The following general guidelines apply and must be used in conjunction with all safety and environmental regulations appropriate for the process and location. -
Page 40: Maintenance
Appropriate precautions must be taken to prevent such corrosion. If corrosive conditions are routinely anticipated, end users must consider opting for tank systems constructed from 316-alloy stainless steel (available from Cytiva upon request). -
Page 41: Reference Information
7 Reference information 7 Reference information About this chapter This chapter lists technical specifications of Stainless steel mixer tank. The chapter also includes recycling information, regulatory information and ordering information, and Health and Safety Declaration form for service. In this chapter Section See page Specifications... -
Page 42: Specifications
For customized tanks, refer to applicable tank drawing for exact specifications. Base part number Dimensions Weight L × W × H LM500JRMA-SMC 1223 × 973 × 1768 mm 426 kg (939 lbs) (48 × 38 × 70 inches) LM1000JRMA-SMC 1454 × 1199 × 1810 mm 660 kg (1453 lbs) (57 ×... - Page 43 2500 L This is the smallest volume of liquid that Cytiva recommends be mixed in the tank. It is defined as being the volume at which the impeller is just covered by the liquid; below this volume, the impeller will be at least partially exposed.
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Page 44: Recycling Information
When taking the product out of service, the different materials must be separated and recycled according to national and local environmental regulations. Recycling of hazardous substances The product contains hazardous substances. Detailed information is available from your Cytiva representative. Disposal of electrical components Waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. -
Page 45: Regulatory Information
7 Reference information 7.3 Regulatory information 7.3 Regulatory information Introduction This section lists the regulations and standards that apply to the product. Your product is marked or listed according to the applicable regulatory requirements for your region. Local language transla- tions are only provided according to regulatory requirements. -
Page 46: Contact Information
To find local contact information for support and sending troubleshooting reports, visit cytiva.com/ contact. Manufacturing information The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Germany GmbH Philipp-Reis-Str. 6 63303 Dreieich Germany Stainless steel mixer tank Operating Instructions USD3194 AA... -
Page 47: European Union And European Economic Area
7 Reference information 7.3 Regulatory information 7.3.2 European Union and European Economic Area 7.3.2 European Union and European Economic Area Introduction This section describes the information that applies to the product in the European Union and Euro- pean Economic Area. Conformity with EU Directives Refer to the EU Declaration of Conformity for the directives and regulations that apply for the CE marking. -
Page 48: South Korea
7 Reference information 7.3 Regulatory information 7.3.3 South Korea 7.3.3 South Korea Introduction This section describes the information that applies to the product in the Republic of Korea. Compliance statement NOTICE Class A equipment (equipment for business use). This equipment has been evaluated for its suitability for use in a business environment. -
Page 49: General Regulatory Statements
7 Reference information 7.3 Regulatory information 7.3.4 General regulatory statements 7.3.4 General regulatory statements EMC emission, CISPR 11: Group 1, Class A statement NOTICE This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. -
Page 50: Spare Parts And Standard Accessories
7 Reference information 7.4 Spare parts and standard accessories 7.4 Spare parts and standard accessories Below table shows a list of recommended accessories and spare parts with their respective part numbers. Table 7.1: Accessories and spare parts Description Part number 500 L Probe support 215-20700-B4N... -
Page 51: Health And Safety Declaration Form
Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival. - Page 52 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
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- Page 54 Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corporation or an affiliate doing business as Cytiva. Allegro and LevMixer are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.
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