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Shimadzu Nexera CL Series Safety Manualline
Shimadzu Nexera CL Series Safety Manualline

Shimadzu Nexera CL Series Safety Manualline

Liquid chromatograph
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Shimadzu Liquid Chromatograph
Nexera CL series
Safety Guideline
1
Introduction
Read this instruction manual thoroughly before using
the product.
Thank you for purchasing this product.
This manual describes the usage cautions, warranty and after-sales service for this
product. Read this manual thoroughly before using the product and operate the product
in accordance with the instructions in this manual.
This product is provided with the instruction manual of each instrument in PDF format.
The PDF documents are included in the instruction manual CD-ROM (Part No.:
228-97193-41). Keep these manuals for future reference.
System Guide (PDF)
Maintenance Guide (PDF)
Instruction Manual for each
product (PDF)
Safety Guideline (Booklet/PDF)
Important
• If the user or usage location changes, ensure that the manual is always kept
together with the product.
• If any manual or a product warning label is lost or damaged, immediately contact
your Shimadzu representative to request a replacement.
• To ensure safe operation, read all this Safety Guideline thoroughly before using
the product.
• To ensure safe operation, contact your Shimadzu representative if product
installation, adjustment, re-installation (after the product is moved), or repair is
required.
Rx Only
Federal Law (U.S.A.) restricts this device to sale by or on the order of a licensed
practitioner.
This manual provides details on how to use the system:
system performance optimization, analysis procedure,
troubleshooting, validation, installation, etc.
Describes the maintenance for each product.
Describes the operation, accessories, options, and
maintenance parts for each product.
This instruction manual.
ã 2020-2023 Shimadzu Corporation. All rights reserved.
Original version is approved in English.
1
228-97195B
Jan. 2023

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Summary of Contents for Shimadzu Nexera CL Series

  • Page 1 Shimadzu representative to request a replacement. • To ensure safe operation, read all this Safety Guideline thoroughly before using the product. • To ensure safe operation, contact your Shimadzu representative if product installation, adjustment, re-installation (after the product is moved), or repair is required.
  • Page 2 • All rights are reserved, including those to reproduce this manual or parts thereof in any form without permission from Shimadzu Corporation. • A part of illustration of this manual might be different from the instrument used.
  • Page 3: Safety Instructions

    Operating Nexera CL System n Intended Use This system is designed to perform qualitative and quantitative analysis of target compounds in a sample matrix and can be used as a liquid chromatograph for general in vitro diagnostic applications. This instrument operates with reduced technician involvement and automation of some, but not all, procedural steps.
  • Page 4 n Precautions for Operation • Read the instruction manuals thoroughly before operating this instrument. Operate the instrument in accordance with the instructions contained therein. Failure to do so may result in impaired performance or a potentially hazardous situation. • Always use the appropriate in vitro diagnostic reagents/standard materials for the application.
  • Page 5 n Installation Site Do not reconfigure the installed system as an in vitro medical diagnostic equipment. Any configuration other than as installed cannot be used as an in vitro medical diagnostic equipment. If connected to a system other than the installed system or the system configuration is changed, the following warning is displayed in LabSolutions.
  • Page 6 The lab table on which this instrument is installed should be strong enough to support the total weight of the LC system. It should be leveled, stable and have a depth of at least 700 mm. Otherwise, the instrument could tip over or fall off the table.
  • Page 7 Use the power cord specified or provided by Shimadzu. Failing to do so may result in electric shock or fire. Do NOT use the power cord specified or provided by Shimadzu for other devices. This product (including accessories) is manufactured for measuring and industrial purposes, and not suitable for household usage.
  • Page 8 Take measures to prevent the instrument from falling in the event of an earthquake or other disaster. Strong vibrations may cause the instrument to fall over, resulting in an injury. The power supply voltage of the instrument is indicated on the label on the back of the instrument.
  • Page 9 Holding the front opening and closing part may also cause damage or removal of the part. For the specified position on each instrument, refer to the Nexera CL Series System Guide "7.1 Installing the System". When opening the doors, be careful not to pinch your fingers.
  • Page 10 n Operation Do NOT use flammable sprays (hair sprays, insecticide sprays, etc.) near the instrument. Otherwise, they could ignite and cause a fire. Never use a cracked reservoir bottle. It could break the reservoir bottles and cause injury or spilled liquid may cause an accident or fire.
  • Page 11 When operating the instrument, close the front door or the front panel. Otherwise, this could result in injury. Take special care when operating the instrument after maintenance. Save samples for repeating measurements. Prepare separate samples for measuring and saving, in case they need to be remeasured due to a product failure or some other encumbrance.
  • Page 12 This may cause an injury or equipment failure. The main cover does not need to be removed for routine maintenance, inspection, and adjustment. Have your Shimadzu representative perform any repairs requiring removal of the main cover. Before inspection and maintenance or replacing parts, turn OFF the main power switch on the rear of the instrument and unplug the instrument.
  • Page 13: Static Electricity Precautions

    This may result in accidents due to electric shock or short circuits. It may also result in an injury or equipment failure. When repair is necessary, request your Shimadzu representative. Failing to so may result in an ignition, electric shock, or injury.
  • Page 14 n Typical Cause of Static Electricity Accidents Static electricity accidents are generally caused by this sequence of events: When liquid is passed through thin tubing at high flow Generation of static rates, as in liquid chromatograph, the electrostatic charges electricity of the flowing matter generate static electricity.
  • Page 15 Preventing Static Electricity Accidents The best way to prevent static electricity accidents is simply to prevent the occurrence and accumulation of electrostatic charges. It is important to take multiple preventive measures simultaneously. If large amounts of flammable solvents are collected in a large container, implement preventative measures 1, 2, and 3 below.
  • Page 16 n Preventive Measure 2 Cover the spaces between the tubing and the sides of the inlet and outlet openings of the waste container with caps or other protective covering. This will prevent any sparks generated outside the container from getting inside. Accessories for this measure Caps for 18-L or 4-L container (with three 3-mm diameter openings) Part No.
  • Page 17 n Preventive Measure 5 If it is not possible to use a conductive waste liquid container, take the following precautions: Place some type of grounded metal object into the liquid. For low conductivity (10 S/m or less) liquids, perform preventive measures 1 through 4.
  • Page 18 Precautions for Mobile Phase Selection and Use Do NOT use resin parts for the high-pressure tubing while pumping at high pressures. Pumping at high pressure may cause resin tubing to be ruptured or disconnected, which could result in mobile phase leaks. Please note the maximum withstand pressure of each part when resin parts are used for the high-pressure tubing.
  • Page 19 If PEEK resin parts are used in the plumbing, do not use the following mobile phases. These mobile phases weaken the PEEK resin, which could result in cracked plumbing and mobile phase leaks. • Concentrated sulfuric acid • Dichloromethane • Concentrated nitric acid •...
  • Page 20: Warranty

    Shimadzu may not be able to provide identical replacement products. 3. Limitation of Liability: (1) In no event will Shimadzu be liable for any lost revenue, profit or data, or for special, indirect, consequential, incidental or punitive damages, however caused regardless of the theory of liability, arising out of or related to the use of or inability to use the product, even if Shimadzu has been advised of the possibility of such damage.
  • Page 21: Software License Agreement

    Software License Agreement PLEASE READ THIS AGREEMENT CAREFULLY BEFORE USING THE SOFTWARE. SHIMADZU Corporation ("SMZ") is willing to license the SMZ software provided herein, together with accompanying documentation (collectively "SOFTWARE") to you only upon the condition that you accept all of the terms and condition contained in this License Agreement.
  • Page 22 6. Limitation of Liability IN NO EVENT WILL SMZ BE LIABLE FOR ANY LOST REVENUE, PROFIT OR DATA, OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES, HOWEVER CAUSED REGARDLESS OF THE THEORY OF LIABILITY, ARISING OUT OF OR RELATED TO THE USE OF OR INABILITY TO USE SOFTWARE, EVEN IF SMZ HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
  • Page 23 Thereafter, such parts may cease to be available. If Shimadzu receives notice of the discontinuation of units or parts, the necessary quantity for the above period is immediately calculated and secured. However, such units or parts...
  • Page 24: Disposal Precautions

    If the deuterium (D2) lamp should be broken or its life is finished, dispose of the lamp separately from general garbage. When disposing of the deuterium (D2) lamp provided from Shimadzu Corporation, select a method, which will not harm the environment or cause bodily injury. Consult your local Government Agencies for a proper disposal method.
  • Page 25: Regulatory Information

    With your co-operation we are aiming to reduce contamination from waste electronic and electrical equipment and preserve natural resource through re-use and recycling. Do not hesitate to ask Shimadzu service representative, if you require further information. Regulatory Information For Europe: The product complies with the following requirements.
  • Page 26: Contact Information

    In order to ensure safety, warning labels are attached in places requiring caution. If a warning label is lost or damaged, obtain a new label through your Shimadzu representative and attach it in the correct position. See "Warning Labels on the Equipment"...
  • Page 27 15.1 Solvent Delivery Pump:LC-40D X3 CL/LC-40D XR CL/LC-40B X3 CL n LC-40D X3 CL/LC-40D XR CL n LC-40B X3 CL Warning Description Labels (Part No. 228-53303-01) Do NOT open the drain valve when the pressure of mobile phase is high, or mobile phase splashes from the tip of the drain tubing.
  • Page 28 15.2 Autosampler: SIL-40C X3 CL/SIL-40C XR CL Warning Description Labels (Part No. 228-69899) During the teaching function, the driving unit operates even with the front panel open. Do not touch moving parts. (Part No. 228-69899) Needle and/or some other parts may have been contaminated with biohazardous substances or toxic substances.
  • Page 29 15.3 Flow Channel Selection Valve: FCV-S CL Warning Description Labels (Part No.228-69898) Indicates a possibility of contamination by biological contaminants. Wear protective gear, such as chemically resistant glove, a chemically resistant mask and protective goggles when handling it.
  • Page 30 15.4 PLATE CHANGER CL Warning Description Labels (Part No. 228-53303) Be careful about the dust on the air filter. A clogged filter may deteriorate the instrument performance. Always attach the air filter (228-53924-06) to prevent failure due to dust intrusion. (Part No.
  • Page 31 15.5 Column Oven: CTO-40C CL Warning Description Labels (Part No. 225-20199) Do NOT touch the parts when the operating temperature of column oven is set to a high temperature (60 °C or over). (Part No. 228-72248) Do NOT forget to tighten tubing completely. Otherwise, leakage may occur.
  • Page 32 15.6 Detector: SPD-40 CL Warning Description Labels (Part No. 037-72999-51) UV light may leak if the top cover is not attached properly. Allow the instrument to cool down adequately before performing the lamp replacement procedure. The lamp compartment is extremely hot just after turning off the lamp.
  • Page 33 15.7 Other symbols symbol Location Meaning On name Plate CE mark In vitro diagnostic medical On name Plate device On name Plate Recycle, electronic equipment On name Plate Consult instruction for use On name Plate Manufacturer On name Plate Manufacturing year and month On name Plate Serial number*1 On name Plate...
  • Page 34 Protective Measure Mechanical Description taken by machine Location user Safety guideline Reference “Quality Control” Incorrect Implement quality Operation measurement control of the Quality control Category results are instrument by output due to routinely measuring improper use of at least one each of Qualified person the instruments four types of...
  • Page 35 16.2 Autosampler: SIL-40C X3 CL/SIL-40C XR CL n Residual Risk Map The "Mechanical Location" and "No." indicated below are in accordance with those in "List of Residual Risks". For details, see "List of Residual Risks". n List of Residual Risks The "No."...
  • Page 36 16.3 Column Oven: CTO-40C CL n Residual Risk Map The "Mechanical Location" and "No." indicated below are in accordance with those in "List of Residual Risks". For details, see "List of Residual Risks". n List of Residual Risks The "No." and "Mechanical Location" indicated below are in accordance with those in "Residual Risk Map".
  • Page 37 Furthermore, read through and understand the content in "Reference" to take appropriate protective measures. Protective Measure Mechanical Description taken by machine Location user System Guide "Prior to Plumbing the High Pressure Flow Line" • To connect tubing, Reference Safety Guideline make sure that the solvent delivery “Precautions for...
  • Page 38 16.4 Detector: SPD-40 CL n Residual Risk Map The "Mechanical Location" and "No." indicated below are in accordance with those in "List of Residual Risks". For details, see "List of Residual Risks". SPD-40 CL...
  • Page 39 n List of Residual Risks The "No." and "Mechanical Location" indicated below are in accordance with those in "Residual Risk Map". Be sure to check the actual "Mechanical Location" referring to "Residual Risk Map". Furthermore, read through and understand the content in "Reference" to take appropriate protective measures.
  • Page 40 16.5 Flow Channel Selection Valve: FCV-S CL n Residual Risk Map The "Mechanical Location" and "No." indicated below are in accordance with those in "List of Residual Risks". For details, see "List of Residual Risks". FCV-S CL n List of Residual Risks The "No."...
  • Page 41 Appendix n Power supply voltage and power consumption for each component: Power Supply Rated Power Voltage Breaking Component Part No. Frequency (indicated on Consumption Capacity the instrument) 100-240 VAC CBM-40 CL 228-65502-55 50 VA 50/60 Hz 50 A (100-240V~) DGU-405 CL 228-65019-55 Supplied from other component 100-240 VAC...
  • Page 42 *1 Mains supply voltage fluctuations are not to exceed 10% of the nominal supply voltage. *2 Connect the instrument to a power outlet that is equipped with a circuit breaker that shuts off the current at the described value or less. For IVDR systems (for Europe),MPM-40 cannot be used.