RR Mechatronics Starrsed NSTA Installation Manual
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RR Mechatronics Starrsed NSTA Installation Manual

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Starrsed NSTA
D0062173-EN Version B01 (27-08-2024)

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Summary of Contents for RR Mechatronics Starrsed NSTA

  • Page 1 Installation manual Starrsed NSTA D0062173-EN Version B01 (27-08-2024)
  • Page 2 De Corantijn 13 1689 AN Zwaag The Netherlands Phone: +31 229 291 129 E-mail: Head office: support@rrmechatronics.com USA/Canada office: supportusa@rrmechatronics.com www.rrmechatronics.com © Copyright RR Mechatronics Manufacturing B.V. All rights reserved. Subject to changes without prior notice. D0062173-EN Version B01 (27-08-2024)

  • Page 3: Table Of Contents

    3.1.1 Unpacking Starrsed NSTA system........
  • Page 4 Contents General safety............Mains power connection.

  • Page 5: Document History Overview

    Document history overview Document history overview D0062173-EN Issue No Date Revised Section(s) Changes Authorised Software version 1.4 update Aug 2024 User interface May 2024 First release D0062173-EN Version B01 (27-08-2024)

  • Page 6: Introduction

    1.1 About this manual This manual describes the installation procedures and information required for the correct and successful commissioning of the Starrsed NSTA. This manual is applicable for the Starrsed model NSTA in the following variants: Variant...

  • Page 7: Instrument Description

    The sodium citrate dilution takes place in a 4+1 ratio and is achieved with ± 3% accuracy. The Starrsed Blood Sedimentation Rate Instrument (hereafter called Starrsed NSTA) is an in vitro diagnostic medical device that automatically carries out the...

  • Page 8: Disclaimer

    Introduction 1.3 Disclaimer Operate and maintain this instrument according to this manual and other instructions from the manufacturer. Defects resulting from improper use will void the product warranty Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The manufacturer disclaims any liability for any direct, indirect, incidental, special or consequential damages of any kind, arising from incorrect use or use of unspecified reagent.

  • Page 9: Intended Purpose

    Intended purpose Intended purpose Automated analyzer for the qualitative in vitro determination of the Erythrocyte Sedimentation Rate (ESR) of human blood samples in conformity with the Westergren standard. For professional use in medical laboratories only. To be used as aid to diagnosis for all patient populations, not restricted by age or any other anatomical or physiological particulars.

  • Page 10: Installation And Commissioning Procedure

    Installation and commissioning procedure Installation and commissioning procedure D0062173-EN Version B01 (27-08-2024)

  • Page 11: Installation

    Cut the binding of box and take out the top protection cover. Remove the outer box. Remove the accessories box. Remove the plastic bag from the Starrsed NSTA. Lift the instrument from the bottom protection cover onto a table. D0062173-EN Version B01 (27-08-2024)

  • Page 12: Lifting Instructions

    Installation and commissioning procedure 3.1.2 Lifting instructions The instrument should be lifted by two persons. Raise all 4 feet by rotating them clock wise, creating a maximum of 20mm finger clearance. User 1 will place one hand onto the bottom of the instrument at area A, user 2 will place their hand at area B, (image 1) Together they will lift the instrument while stabilizing it with the other hand at a minimum height of 440mm, section C) (image 2)

  • Page 13: Install At Chosen Location

    Avoid direct sunlight shining on the Starrsed NSTA. Avoid draught which may cause temperature changes. Place the Starrsed NSTA on a levelled and stable table, with no nearby vibration. Do not place in direct airflow of an air conditioning unit.

  • Page 14: Connection And Commissioning Procedure

    Installation procedure: Use parts from the commissioning parts set. Check correct position of the waste pump tube. Connect mains, switch the Starrsed NSTA. Connect LIMS ethernet cable. Set-up and check/adjust all settings. Check the temperature sensor. Check the barcode reader function.

  • Page 15: Control Pipette Measurement (19)

    Installation and commissioning procedure Connect instrument to central waste connection. If needed: cut a small length of the waste tube and connect the waste line with use of the delivered elbow to prevent a possible blockage in the waste line. Prime the fluid system and make sure there are no air bubbles in the diluent line.
  • Page 16 Installation and commissioning procedure Login as FSE. Select the pipette position of the placed control pipettes on the rotor tab. Press Test pipette. The actual readout is presented as ESR result. The graph represents the direct un-modified signal of the measuring head. This readout should match the calibrated value of the control pipette within ±...

  • Page 17: Performance Characteristics And Specifications

    Performance characteristics and specifications Performance characteristics and specifications 4.1 Technical specifications Instrument model Variant Catalogue number (REF) Starrsed NSTA 230V/240V A0030113 120V A0030112 ESR method Westergren method ICSH J. M. Jou; Int. Journal of Laboratory Hematology 2011; 33: 125-132 CLSI Procedures for the Erythrocyte Sedimentation Rate Test;...
  • Page 18 Performance characteristics and specifications Barcode reader type CCD. Reading capabilities Code39, Code128 Electrical requirements Mains voltage 120V/230V/240V(± 10%), 50/60 Hz(± 3%) Slow blow 230V/240V, 2x1,6 Amp Fuse (20 x 5 mm) Slow blow 120V, 2x3,15 Amp Rated power consumption 200 VA Typical power consumption Standby 70 VA / Operation 100 VA Thermal output...
  • Page 19 Performance characteristics and specifications Languages EN-DE-FR-IT-ES-PT Maintenance Preventive maintenance calls per year Starrsed Diluent: depending on number of samples/day, approx. Consumables replacement once every 5 days at 90 samples/day to once every 2 days at frequency 260 samples/day. Starrsed X-Clean: maximum every 3 months Compliance Classification EU Class A...

  • Page 20: Used Reagents

    Performance characteristics and specifications 4.2 Used reagents NOTE: The latest version of the Safety Data Sheet (SDS) of the used reagents can be found on our web site These reagents are classified as not hazardous according to regulation (EC)1272/2008 [CLP] Starrsed Diluent Intended purpose: Product for the automatic dilution of blood samples in Starrsed ESR analyzers.

  • Page 21: User Levels

    (2m), installed on slope to the waste system. To avoid spillage, the waste line of the Starrsed NSTA must be mechanically secured and tightly connected to the Lab drain, this prevents that the waste line accidentally disconnects from the drain.

  • Page 22: Fluid Connections

    Performance characteristics and specifications 4.5 Fluid Connections Fluid connections 4.6 Network connections ETH01 LIMS ETH02 reserved for other network connections D0062173-EN Version B01 (27-08-2024)

  • Page 23: Identification And Labelling

    Performance characteristics and specifications 4.7 Identification and Labelling Example of type plates: This label indicates the voltage configuration / used fuses in which the instrument is delivered. The voltage cannot be changed. Compliance label: D0062173-EN Version B01 (27-08-2024)

  • Page 24: User Interface And Software Menu

    User interface and software menu User interface and software menu The main tabs are described in this chapter, more information is explained in the applicable chapters throughout the manual. Software version: 1.4. The following functions are available: Function Operator Supervisor Start/Stop processing Rotor Home Replace reagents...

  • Page 25: Login

    User interface and software menu General Settings End-of-day wash LIMS Limit errors Network Advanced 5.1 Login It is not needed to login for normal operation. For supervisor and FSE functionality is a login required. D0062173-EN Version B01 (27-08-2024)

  • Page 26: Home Screen

    User interface and software menu 5.2 Home screen On the home screen general information is shown on two tabs, Carousel (p. 27) and Rotor (p. 28): The following items are always shown on the right side: Status of the used reagents Press on one of the gauges for more reagent information Status and date of latest QC sample measurement End-of-Day wash scheduled time...

  • Page 27: Carousel Tab

    User interface and software menu 5.2.1 Carousel tab Pipette status in the carousel: Filled pipette Empty pipette Disabled pipette Pipette with failed aspiration or dirty Pipette at fill/rinse position Status of process Idle/Production By pressing on one pipette number is shown detailed information: Pipette status e.g.

  • Page 28: Rotor Tab

    User interface and software menu 5.2.2 Rotor tab The status of each pipette is indicated by means of colors and lines: Blue Sample tube detected in rotor, to be processed Green Sample was aspirated successfully Sample was aspirated, but with fill errors (No ESR measurement can be done).
  • Page 29 User interface and software menu To enter a barcode from a sample tube manually, available for supervisor. Information and status of one tube on the rotor is shown after selecting a specific tube on the screen: D0062173-EN Version B01 (27-08-2024)

  • Page 30: Warnings And Errors

    User interface and software menu 5.2.3 Warnings and errors Warnings and errors are indicated in the bottom-right corner. Warnings are displayed in orange and errors in red. The complete message is displayed when pressed on the specific warning or error. Error list (p.

  • Page 31: Information Screen

    User interface and software menu 5.3 Information screen Information can be used to view and export information of ESR and QC measurements (only visible for Data search Supervisor), see ESR Reporting. (p. 33) will provide information about versions of software used in the instrument. Software information (p.
  • Page 32 User interface and software menu The three types of events (warning/error/info) can be filtered: General events are also made visible at the bottom of the main screen: D0062173-EN Version B01 (27-08-2024)

  • Page 33: Software Information

    User interface and software menu 5.3.2 Software information On this screen: • The installed software version • Where to find more License information • Update software function, see chapter Software update (p. 33) 5.3.2.1 Software update Download new software from the website www.rrmechatronics.com. Place the file on an USB-Stick.

  • Page 34: General Settings Tab

    User interface and software menu General (p. 34) End-of-day wash (p. 38) Limit errors (p. 40) LIMS (p. 39) Network configuration (p. 43) Advanced (p. 35) 5.4.1 General settings tab The following items can be set on this screen: Used ESR Method (30 min/60 min) •...

  • Page 35: Advanced Settings Tab

    User interface and software menu Can be used to choose between the classic one-hour sedimentation method and the Starrsed 30 minute sedimentation period, where the result is corrected to a Westergren equivalent value using a proven conversion method. Use temperature corrected ESR (ON/OFF) •...
  • Page 36 User interface and software menu Carousel commands Ready for storage: Can be used if the instrument has to be stored. Instrument Config: Log Level This setting is used to control the granularity of logging the instrument software. This gives the user the opportunity to change the log overview settings and to save system memory.
  • Page 37 User interface and software menu • LevelVerbose- logging all events. • LevelTrace - logging only useful events. • LevelWarning, logging only events from warnings and up. • LevelError, logging only errors and up. • LevelFatal, logging only fatal errors. Run Mode With this setting other run modes can be selected to test the instrument.

  • Page 38: End-Of-Day Wash Settings Tab

    User interface and software menu Machine ID • The instrument serial number (or a instrument ID chosen by the customer) can be filled in here. 5.4.3 End-of-day wash settings tab Scheduling can be configured as daily, weekly or custom. • Daily will schedule the End-of-Day Wash at every day in which samples have been processed.

  • Page 39: Lims Settings Tab

    User interface and software menu 5.4.4 LIMS settings tab LIMS LIMS Protocol: This setting can be used to select the protocol (p. 76) to use in communication with the LIMS (p. 76) server. The following protocols can be selected: Mechatronics 1 (Bi-directional) Mechatronics 2 (Uni-directional) Sysmex SE-9000 Sysmex R-3500...

  • Page 40: Limit Error Settings Tab

    User interface and software menu Sysmex R-3500 EPU Siemens Advia 120 Siemens Advia 120 Unidirectional IP Address: This setting can be used to set the IP address of the LIMS server. TCP Port: Sets the port used for communication with the LIMS server. Deselect "Enabled"...
  • Page 41 User interface and software menu Limit error options: Sedimentation time deviation • Only send results when ESR time is below a certain amount of minutes Column height deviation • Only send results with a selected deviation of standard column height 200 mm ("20"=column height 180mm, "30"=column height 170mm) Temperature out of range •...
  • Page 42 User interface and software menu An input screen appears when one value field is selected: It is possible to enable one or more options: D0062173-EN Version B01 (27-08-2024)

  • Page 43: Network Tab

    User interface and software menu Press "Save changes" to save these settings. 5.4.6 Network tab The instrument can be connected to the local network with a dynamic or static IP-address. Assign an individual IP address and gateway for the instrument when DHCP is disabled. Press "Save changes"...

  • Page 44: Service Screen

    User interface and software menu 5.5 Service screen Service Start Daily maintenance (p. 45) Cleaning and priming (p. 45) Repair mode: This will set the instrument in the repair mode Register maintenance (p. 46): To confirm the yearly maintenance is done: D0062173-EN Version B01 (27-08-2024)

  • Page 45: Daily Maintenance

    User interface and software menu 5.5.1 Daily maintenance Daily maintenance options: End-of-day wash for performing End-of-Day wash manually. Needle inspection to check and clean needle assembly. Nozzle inspection to check and clean the fill nozzle. 5.5.2 Clean and prime Cleaning: D0062173-EN Version B01 (27-08-2024)

  • Page 46: Register Maintenance

    User interface and software menu Clean all pipettes: To perform a cleaning cycle on all pipettes in the carousel. Clean filled pipettes: To perform a cleaning cycle on only the filled pipettes, can be used after an error occured and the samples have been sedimented too long. Priming: will initiate priming steps.

  • Page 47: Operational Precautions, Limitations And Hazards

    Operational precautions, limitations and hazards Operational precautions, limitations and hazards 6.1 General safety The instrument described in this manual is designed to be used by properly trained personnel only. For the correct and safe use of this instrument it is essential that both operating and servicing personnel follow generally accepted safety procedures in addition to the safety precautions specified in this manual.

  • Page 48: Mains Power Connection

    Operational precautions, limitations and hazards Risk control measures have been implemented in the design. It is always important to read the information provided by the manufacturer and to follow the safety instructions. All risks of the device have been evaluated separately and the overall risk has also been weighed against the benefits of its use.

  • Page 49: Interference Measures

    Operational precautions, limitations and hazards 6.3 Interference measures This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 50: Explanation Of Symbols

    Operational precautions, limitations and hazards 6.4 Explanation of symbols The following symbols can be used in this manual and for the instrument: Warning sign to prevent personal injury due to biohazard. Warning sign to prevent personal injury due to rotating parts. Warning sign to prevent personal injury due to sharp objects.

  • Page 51: Troubleshooting

    Troubleshooting Troubleshooting Warnings and errors are indicated on the home screen at first. This message includes a situation description and a first, possible solution on Users level. Possible solutions on FSE-level are indicated in the Error list 54). Closed, but not solved errors are listed on the home screen. For a correct handling of errors, follow the instructions from the Error list (p.

  • Page 52: Troubleshooting During Sampling

    Troubleshooting In case of errors during sedimentation, all filled pipettes can be emptied and cleaned with Clean filled pipettes Advanced settings (p. 35). 7.1 Troubleshooting during Sampling Processing of the rotor not started Rotor not mounted or mounted correctly Rotor position failure Start condition failure: ▪...

  • Page 53: Replacement Of Plunger Tips

    Troubleshooting 7.3 Replacement of plunger tips Prepare a small container and fill it with X-Clean. 5ml should be sufficient. Pull the Piston (BANG020002) out the pipette. Use cutting pliers to remove the tip. Replace the tip (BANG020003) by using the service tool (BANG020023). Dip the new tip in X-Clean and put it back into the pipette.

  • Page 54: Error List

    Error list Error list U=Can be solved by User S=Can be solved by Service Engineer F100 Carousel position error while moving Carousel manually moved Check the carousel position sensor (S14) Position sensor defect Replace sensor (S14) F101 Carousel next position error while moving Carousel obstructed Remove carousel obstruction Check the carousel position sensor (S14)
  • Page 55 Error list F111 Carousel motor error during homing. The carousel is unable to reach its intended position. Carousel obstructed Remove carousel obstruction Check the carousel motor (M6) and sensors Carousel motor defect Replace motor (M6) F112 Carousel motor error while moving. The carousel is unable to reach its intended position. Carousel obstructed Remove carousel obstruction Check the carousel motor (M6) and sensors...
  • Page 56 Error list F300 Barcode communication timeout Barcode software issue Switch instrument OFF, wait 10 seconds and switch instrument ON to restart the instrument. Barcode scanner defect Replace barcode scanner F301 LIMS communication timeout The LIMS order of a sample tube could not be Check LIMS connections and settings (on received due to a communication issue.
  • Page 57 Error list Blocked sensor(s) Clean nozzle and surrounding parts Sensor defect Replace sensor S3/S4 F408 Nozzle sensor error moving to wash position during flushing Blocked sensor(s) Clean nozzle and surrounding parts Sensor defect Replace sensor S3/S4 F409 Nozzle sensor error moving to bottom during slushing Blocked sensor(s) Clean nozzle and surrounding parts Sensor defect...
  • Page 58 Error list Sensor defect Replace sensor S3/S4 F418 Nozzle sensor error moving to to fill position during prime X-Clean Blocked sensor(s) Clean nozzle and surrounding parts Sensor defect Replace sensor S3/S4 F419 Nozzle sensor error moving to home position during Prime X-Clean Blocked sensor(s) Clean nozzle and surrounding parts Sensor defect...
  • Page 59 Error list F428 Gripper translate error to Home during emptying pipette Blocked sensor(s) Check gripper position and surrounding parts Sensor defect Replace sensor F430 Gripper angular error while closing during filling pipette Blocked sensor(s) Check gripper position and surrounding parts Sensor defect Replace sensor F431...
  • Page 60 Error list F440 Nozzle sensor error moving to wash during remove fluids Blocked sensor(s) Check needle and surrounding parts Sensor defect Replace sensor F441 Nozzle sensor error moving to home during remove fluids Blocked sensor(s) Check needle and surrounding parts Sensor defect Replace sensor F444...
  • Page 61 Error list Motor defect Replace motor (M2) F452 Nozzle motor error during aspiration Motor path obstructed Check or clean nozzle and surrounding parts Motor defect Replace motor (M2) F453 Nozzle motor error during filling Motor path obstructed Check or clean nozzle and surrounding parts Motor defect Replace motor (M2) F454...
  • Page 62 Error list F463 Gripper translate motor error during filling Motor path obstructed Remove obstruction Motor defect Replace motor (M4) F464 Gripper translate motor error error during emptying Motor path obstructed Remove obstruction Motor defect Replace motor (M4) F465 Gripper translate motor error during removing fluids Motor path obstructed Remove obstruction Motor defect...
  • Page 63 Error list Motor path obstructed Remove obstruction Motor defect Replace motor (M5) F474 Gripper actuator motor error during emptying Motor path obstructed Remove obstruction Motor defect Replace motor (M5) F475 Gripper actuator motor error during remove fluids Motor path obstructed Remove obstruction Motor defect Replace motor (M5)
  • Page 64 Error list Pump (P1) defect Replace pump F484 Peristaltic pump error during emptying Motor Path Obstructed Check pump and surrounding parts Pump (P1) defect Replace pump F485 Peristaltic pump error during washing Motor Path Obstructed Check pump and surrounding parts Pump (P1) defect Replace pump F486...
  • Page 65 Error list Sensor defect Replace sensor F495 Fluid path not dry during Prime diluent Air Leak (tubing. Connections) Fix leak in tubing or connections Blocked sensor(s) Check sensor Sensor defect Replace sensor Motor defect Replace motor F496 Diluent not detected during Prime diluent Diluent container empty Replace diluent container Air Leak (tubing.
  • Page 66 Error list F504 Rotor motor error during inverting Movement obstructed Check rotor motor and surrounding parts Motor defect Replace motor F505 Rotor motor error during positioning Movement obstructed Check rotor motor and surrounding parts Motor defect Replace motor F506 Rotor motor error during piercing cap Movement obstructed Check rotor motor and surrounding parts Motor defect...
  • Page 67 Error list Movement obstructed Check needle motor and surrounding parts Motor defect Replace motor F515 Needle motor error during positioning Movement obstructed Check needle motor and surrounding parts Motor defect Replace motor F516 Needle motor error during piercing cap Movement obstructed Check needle motor and surrounding parts Motor defect Replace motor...
  • Page 68 Error list Sensor defect Check sensor mounting and cabling intermittent sensor connection Replace sensor F540 Rotor position error during positioning Software issue If errors persists, restart the instrument F541 Needle position error during positioning Intermittent sensor connection Check sensor mounting and cabling Sensor defect Replace sensor F547...
  • Page 69 Error list F557 Unable to rotate the rotor The rotor may be blocked. Check and remove blockade. F560 Needle not at flush position during removal Software issue If errors persists, restart the instrument F561 Needle sensor error during rotor removal (Unlock position) Needle sensor error Check needle and surrounding parts Intermittent sensor connection...
  • Page 70 Error list Reagent out of date Replace X-Clean container F620 Failed to interpret LIMS message Unstable network connection Check LIMS configuration or network connection F621 No Response From LIMS Server Unstable network connection Check LIMS configuration or network connection Incorrect LIS configuration Check LIMS configuration or network connection F622 Negative response received from LIMS server...
  • Page 71 Error list Temperature correction not enabled Enable Temperature correction F650 Software update error while extracting Software issue Download update archive again USB drive defect Replace USB drive F651 Software update error: Archive corrupt Software issue Download update archive again USB drive defect Replace USB drive F652 Software update error: Installation failed...
  • Page 72 Error list ESR Measurement >140 mm F674 ESR Report: Bubbles on top Warning Instrument failure Check instrument F675 ESR Report: Temperature out of range <18°C Ambient temperature too low Raise ambient temperature Temperature sensor defect Replace Temperature and ESR board F676 ESR Report: Temperature out of range >28°C Ambient temperature too high...

  • Page 73: Appendix

    Appendix Appendix D0062173-EN Version B01 (27-08-2024)
  • Page 74 Appendix D0062173-EN Version B01 (27-08-2024)

  • Page 76: Glossary Of Terms

    Bidirectional communication means that there is two-way communication from the Starrsed NSTA to the HOST (sample requests and results) and from the HOST to the Starrsed NSTA (confirmation or denial of sample requests). undiluted samples collected in tubes with EDTA anticoagulant . The samples are...

  • Page 77: Index

    Index Index Installation and commissioning procedure..Instrument description..... About this manual......Intended purpose.
  • Page 78 Troubleshooting......Troubleshooting during Sampling... . . Unpacking Starrsed NSTA system... . . Used reagents.

This manual is also suitable for:

Starrsed nsta 230v/240vStarrsed nsta 120vA0030113A0030112

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