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Related Manuals for RR Mechatronics Starrsed NSTA
Summary of Contents for RR Mechatronics Starrsed NSTA
- Page 1 Instructions for Use Starrsed NSTA D0062172 -EN Version B01 (19-07-2024)
- 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. D0062172 -EN Version B01 (19-07-2024)
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Page 3: Table Of Contents
Contents Contents Document history overview........... . . 1 Introduction. - Page 4 Contents 8.2.1 Carousel tab............8.2.2 Rotor tab.
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Page 5: Document History Overview
Document history overview Document history overview D0062172 -EN Issue No Date Revised Section(s) Changes Authorised General update including software July 2024 version A0031150 A01 update First release May 2024 D0062172 -EN Version B01 (19-07-2024) -
Page 6: Introduction
Standard operation procedure (p. 22) and Operational precautions, limitations and hazards before using the instrument. 1.1 About this manual This manual is applicable for the Starrsed NSTA model in the following variants: Variant Catalogue number (REF) Starrsed NSTA 230V/240V A0030113... -
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: Main Components
Introduction 1.3 Main components Rotor Needle assembly Needle cover Service door Fill nozzle Carousel with pipettes User interface screen Reagent and waste connections Identification labels Power switch USB-connection Service door lock D0062172 -EN Version B01 (19-07-2024) -
Page 9: Indication For Use Of Device
Introduction 1.4 Indication for use of device For screening and follow-up of patients with (suspected) inflammatory conditions. As stated in the intended purpose, the Starrsed instrument is for professional use in medical laboratories only. All personnel that will interact with the device in any way must be properly trained by the legal manufacturer or representatives thereof. -
Page 10: Disclaimer
Introduction 1.5 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 11: 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 12: Installation Procedures And Requirements
Installation procedures and requirements Installation procedures and requirements Users are not allowed to install and connect the instrument. The instrument must be unpacked, installed and checked by a trained engineer (FSE) prior to first operation. Installation procedures and requirements are described in the Installation manual. D0062172 -EN Version B01 (19-07-2024) -
Page 13: Principles Of Operation
Principles of operation Principles of operation The sampling process: Manual process: Fill rotor with up to 10 sample containers (place with the barcode facing towards the outside) Place rotor at process position Press the ‘Start processing rotor’ button on the touch screen Automated process steps: Homogenization (mixing) of blood sample Positioning of blood sample container at needle... -
Page 14: Performance Characteristics And Specifications
Performance characteristics and specifications Performance characteristics and specifications 5.1 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 15 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 16 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...
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Page 17: Sedimentation Measurement Principle
Performance characteristics and specifications 5.2 Sedimentation measurement principle The automatic reading of the Westergren sedimentation pipettes is performed by moving an optical sensor along the pipettes. While the sensor is moving, it is taking a reading every 0.25 mm. The sensor is reading the absorption of infrared light through the Westergren pipette filled with blood. -
Page 18: Time Of Test
Performance characteristics and specifications 5.3 Time of test Where possible, testing should be started within four hours of collection if the specimen was held at room temperature. If longer storage is required, testing can be started up to 24 hours later if specimens are kept refrigerated and returned again to room temperature for 15 minutes before testing. -
Page 19: Used Reagents
Performance characteristics and specifications 5.4 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 20: 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 21: Identification And Labelling
Performance characteristics and specifications 5.7 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: D0062172 -EN Version B01 (19-07-2024) -
Page 22: Standard Operation Procedures
Switch ON procedure: • Check waste and reagent connections. • Switch the Starrsed NSTA ON. • Wait until the Home page is visible on the display and the process status is shown as "Idle". • If errors or warnings appear on the home screen, solve them accordingly where applicable. - Page 23 Standard operation procedures • The front service door must be closed and locked and the needle service cover must be closed during normal operation. • The instrument is now ready for normal operation. D0062172 -EN Version B01 (19-07-2024)
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Page 24: Sampling Procedure
Standard operation procedures 6.2 Sampling procedure The front service door and the needle service cover must be closed during normal operation. Remove the rotor from the instrument. This is only possible if the rotor is in "Idle"-status. Remove rotor If applicable: Remove already processed tubes from rotor. - Page 25 Standard operation procedures 4. Press "Start processing rotor" Press Start processing rotor 5. Confirm with "Start processing" to start the sampling process. Each time a rotor is placed in the instrument and processing starts, all samples will be inverted 12 times before starting first aspiration.
- Page 26 Standard operation procedures After processing all tubes, the rotor can removed when it shows idle status. The rotor can then be filled again. Note: If an identical barcode is read (and identified as reported result) within 24 hours it will not be processed until it is confirmed the sample should be re- examined.
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Page 27: Manually Entering Sample Barcodes
Standard operation procedures 6.2.1 Manually entering sample barcodes It is possible to enter sample identification manually in case sample tubes have unreadable or damaged barcodes. This function is available after login as Supervisor. Remove the rotor from the instrument, samples which are already processed have to be removed. (see chapter Rotor tab (p. -
Page 28: Replacement Of Reagents
Standard operation procedures 6.3 Replacement of reagents Reagent levels are calculated by the instrument. A warning is displayed if the calculated content of a reagent container drops below 250 ml. At this point the user can choose to continue using the instrument or replace the reagent. -
Page 29: Adding New Lab Users
Standard operation procedures Enter Lot number. Enter Expiry date. Press Submit. 6.3.1 Adding new lab users Press Add Lab user. Enter name and surname. Note that the system is case sensitive. D0062172 -EN Version B01 (19-07-2024) - Page 30 Standard operation procedures Press Submit. D0062172 -EN Version B01 (19-07-2024)
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Page 31: Reporting
Standard operation procedures 6.4 Reporting Results are sent to the LIMS according to the selected protocol. The Starrsed NSTA is able to handle different types of protocols. No patient data is stored in the instrument. A protocol is a set of rules governing the communication and the transfer of data between devices, such as a computers or server. -
Page 32: Esr Reporting
Standard operation procedures 6.4.1 ESR Reporting Information -> Data search On the data search page, the following information can be shown: ESR measurement results QC sample measurement results Select the data type (ESR Report/ESR QC Sample Report)and the starting and ending date of the period of interest. - Page 33 Standard operation procedures Results are presented in table format, showing columns: Barcode Status (successful or failed, also indicated in blue or orange) ESR result (ESR60 if temperature compensation is disabled or TCESR 60 if it is enabled) Hazy Scan date Reports can be exported to an USB-drive with "Export reports to USB"...
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Page 34: Esr Report Messages
Standard operation procedures This view shows the measurement graph with measurement points every 0.25mm along the pipette as well as the detailed information: ESR 60 ESR 30 in case of using the 30 minute sedimentation time. ESR 60 TC (if temperature correction is enabled) Temperature Total sedimentation duration Column height... -
Page 35: Check Before Starting Up After Inactive Period
Standard operation procedures Example of a limit error message: • L_err( 42/ 84/ 75/200) means 42 mm in the 30 minute method and temperature correction 75 with a correct column height. • L_err(---/ 84/ 75/200) means 84 mm in the 60 minute method and temperature correction 75 with a correct column height. -
Page 36: Calibration Procedures
Starrsed Control is an in-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. The correct function of the hardware and software of the Starrsed NSTA measurement unit should be checked at regular intervals with the aid of Mechatronics Control Pipettes (Order nr. QTST049000). -
Page 37: Expected Value Range
Calibration procedures 7.1.2 Expected value range Starrsed Control is assayed for Starrsed ESR analyzers. The software always calculates a temperature corrected result because only temperature corrected results can be compared with the Assay mean value. The assayed mean values, expected ranges and reference values are derived from validation measurements on multiple instruments at different sites. -
Page 38: Quality Control Procedure
Calibration procedures 7.1.5 Quality control procedure Always perform a QC measurement with an empty carousel. When using LAB ID: Link the Lab ID with Starrsed Control Sample ID. Attach the lab ID label on the tube on top of the original Starrsed Control label Rub the Starrsed Control tube between hands until packed cells have been completely re-suspended. - Page 39 Calibration procedures If results are incidentally out of range it is advised to perform an End-of-Day wash and then perform another QC sample step before releasing patient results. Results can be sent to the LIMS for further analysis in lab's own Quality Control data system. D0062172 -EN Version B01 (19-07-2024)
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Page 40: 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: A0031150 A01. The following functions are available: Function Operator Supervisor Start/Stop processing Rotor Home... -
Page 41: Login
User interface and software menu General Settings End-of-day wash LIMS Limit errors Network Advanced 8.1 Login It is not needed to login for normal operation. For supervisor and FSE functionality is a login required. D0062172 -EN Version B01 (19-07-2024) -
Page 42: Home Screen
User interface and software menu 8.2 Home screen On the home screen general information is shown on two tabs, Carousel (p. 43) and Rotor (p. 44): 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 43: Carousel Tab
User interface and software menu 8.2.1 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 44: Rotor Tab
User interface and software menu 8.2.2 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 45: Warnings And Errors
User interface and software menu Aspiration position 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: 8.2.3 Warnings and errors Warnings and errors are indicated in the bottom-right corner. - Page 46 User interface and software menu The complete message is displayed when pressed on the specific warning or error. Error list (p. 77) for more information concerning warnings and errors. Explanation of the buttons: Close: The dialog is closed but the warning/error is not removed. The error/warning will still be visible in the lower right panel of the main screen.
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Page 47: Information Screen
User interface and software menu 8.3 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. 32). (p. 49) will provide information about versions of software used in the instrument. Software information (p. - Page 48 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: D0062172 -EN Version B01 (19-07-2024)
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Page 49: Software Information
User interface and software menu 8.3.2 Software information D0062172 -EN Version B01 (19-07-2024) -
Page 50: Service Screen
User interface and software menu 8.4 Service screen Service Start Daily maintenance (p. 68) Clean and prime (p. 51) 8.4.1 Daily maintenance Daily maintenance options: D0062172 -EN Version B01 (19-07-2024) -
Page 51: Clean And Prime
User interface and software menu (p. 73) for performing End-of-Day wash manually. End-of-day wash (p. 69) to check and clean needle assembly. Needle inspection (p. 71) to check and clean the fill nozzle. Nozzle inspection 8.4.2 Clean and prime Cleaning: Clean all pipettes: To perform a cleaning cycle on all pipettes in the carousel. -
Page 52: Settings Screen (Supervisor)
User interface and software menu 8.5 Settings screen (Supervisor) Log in as supervisor using the supervisor pin code. Select the icon to navigate to the settings page. There are five tabs on this screen: General (p. 52) End-of-day wash (p. 53) Limit errors (p. -
Page 53: End-Of-Day Wash Settings Tab
User interface and software menu This setting can be used to change the time zone. First the continent is selected, next the city. The combination of these will uniquely identify a time zone. Date format (DD-MM-YY/MM-DD-YYYY/YYYY-MM-DD) • This setting can be used to select the date format to use in the user interface and in exported data. •... -
Page 54: Limit Error Settings Tab
User interface and software menu Daily will schedule the End-of-Day Wash at every day in which samples have been processed. It will • check if samples have been processed in the last 24 hours, and if so, start End-of-Day Wash at the configured time. - Page 55 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 56 User interface and software menu An input screen appears when one value field is selected: It is possible to enable one or more options: D0062172 -EN Version B01 (19-07-2024)
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Page 57: Lims Settings Tab
User interface and software menu Press "Save changes" to save these settings. 8.5.4 LIMS settings tab LIMS LIMS Protocol: This setting can be used to select the protocol (p. 84) to use in communication with the LIMS (p. 84) server. The following protocols can be selected: D0062172 -EN Version B01 (19-07-2024) -
Page 58: Network Tab
User interface and software menu Mechatronics 1 (Bi-directional) Mechatronics 2 (Uni-directional) Sysmex SE-9000 Sysmex R-3500 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. - Page 59 User interface and software menu Assign an individual IP address and gateway for the instrument when DHCP is disabled. Press "Save changes" to save these settings. D0062172 -EN Version B01 (19-07-2024)
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Page 60: Operational Precautions, Limitations And Hazards
Operational precautions, limitations and hazards Operational precautions, limitations and hazards 9.1 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 61 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.
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Page 62: Interference Measures
Operational precautions, limitations and hazards 9.2 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 63: Explanation Of Symbols
Operational precautions, limitations and hazards 9.4 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 64: Troubleshooting
Troubleshooting Troubleshooting Warnings and errors appearing as a pop-up at first. This message includes a situation description and a first, possible solution on Users level. The errors will remain visible in the events screen on the home screen. The background will remain at the color of the latest warning or error. -
Page 65: Leaking Pipettes
Troubleshooting When instructed, the instrument has to be turned OFF and ON again to solve hard- and/or software errors. In most cases, the instrument will be ready for production again. In case of recurring error, contact your service representative. In case of severe leakage issues at the sampling side of the instrument: Contact your service representative. 10.1 Leaking pipettes Pipettes may leak if the plunger tip is worn. -
Page 66: Needle And Aspiration Problems
Troubleshooting 10.4 Needle and aspiration problems Open needle cover and check needle assembly according Inspect and clean needle (p. 69) procedure. If needle is not returning to home position: Switch instrument OFF, wait 10 seconds and switch instrument ON to restart the instrument. D0062172 -EN Version B01 (19-07-2024) -
Page 67: Maintenance
Maintenance Maintenance The needle service hatch is accessible when the rotor is removed. The front service door can be opened with the service tool. 11.1 Maintenance schedule Daily Clean rinse mounting block Inspect and clean needle Inspect and clean fill nozzle and compartment Perform End-of-day wash (if not performed automatically) Clean the instrument where dirt or blood may be... -
Page 68: Daily Maintenance
Maintenance Consumables: Reagent: Order number: Starrsed Diluent QRR 010931 Starrsed X-Clean QRR 010946 11.3 Daily maintenance The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible. Use disinfectant for cleaning of all external parts that are exposed to blood. Wipe the lower tube holder of the needle unit. -
Page 69: Clean And Inspect Needle
Maintenance 11.3.1 Clean and inspect needle Service -> Daily maintenance - > Needle inspection The needle inspection options allow access to the needle so it can be inspected and (if necessary) cleaned. During this procedure the needle will become accessible, so it must be executed with care. Make sure the instrument is in Idle state. - Page 70 Maintenance Press ‘Confirm’ to move the needle to the inspection position. An additional warning screen appears: When the needle is in position, the following screen is shown: Clean the needle. Use an alcohol wipe to wipe the needle (A). D0062172 -EN Version B01 (19-07-2024)
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Page 71: Inspect And Clean Fill Nozzle
Maintenance Clean the rinse mouting block (B) and other surroundings. Inspect the tip for burrs and damage (DO NOT USE YOUR FINGERTIPS) and check if the needle is straight. Check if there is no debris in and around the holes and no leakage in the small hole (C) above the retainer clip. - Page 72 Maintenance Press Confirm. Unlock and open the front service door. Check that the nozzle is down. Use the thumbscrew as indicated in the picture to loosen the fill nozzle (use a screwdriver). Once it is loose, do not remove any tubing. D0062172 -EN Version B01 (19-07-2024)
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Page 73: End-Of-Day Wash Function
Maintenance Inspect the nozzle: ▪ Leave the tubing connected. ▪ Check black O-ring is present in the nozzle and placed well. ▪ Inspect red flat sealing ring has no burrs. ▪ If necessary, clean the nozzle: Clean the nozzle with a toothbrush and detergent. Check and eventually clean surroundings in the carousel compartment: ▪... -
Page 74: Cleaning Of The Outside Of The Instrument
Maintenance The purpose of this function is to clean the inside of the pipettes from residue which may have accumulated over time. This process can be started only when there are no samples in the carousel. It will take approximately 20 minutes to complete. All pipettes are automatically filled with X-Clean. -
Page 75: System Temporarily Out Of Use
System temporarily out of use System temporarily out of use Perform End-of-Day wash. Switch OFF the instrument. Clean the instrument inside and outside. Disconnect reagents and waste connection. D0062172 -EN Version B01 (19-07-2024) -
Page 76: Decommissioning And Disposal
Decommissioning and disposal Decommissioning and disposal Only to be performed by a trained engineer. In case of permanent removal of the instrument: Remove all data from the embedded software on the instrument. Clean the accessible parts from the inside and outside of the instrument in case of severe pollution. Disconnect all cables from external devices. -
Page 77: Error List
Error list Error list Explanation: Error message Error number Possible cause Action F100 F114 Carousel error Carousel manually moved Switch instrument OFF, wait 10 seconds and switch Carousel obstructed instrument ON to restart the instrument. In case of recurring error, contact your service representative. Sensors or motor failure F200 /202 ESR Motor error... - Page 78 Error list X-Clean container empty Replace X-Clean container or check tubing and connections for air leaks Air bubbles in reagent supply Perform a Prime X-Clean step (p. 51) F402 Fluid path not empty during filling tubing with X-Clean Air leak in tubing or connections Check for leaks in tubing or connections F403 Starrsed X-Clean not detected during filling with X-Clean...
- Page 79 Error list Motor obstructed/Motor defect Press Retry. In case of recurring error, contact your service representative. F490/493 Gripper error Motor obstructed/Motor defect Press Retry. In case of recurring error, contact your service representative. F495 Fluid path not dry during Prime diluent Air Leak (tubing.
- Page 80 Error list Sensor defect intermittent sensor connection Switch instrument OFF, wait 10 seconds and switch instrument ON to restart the instrument. In case of recurring error, contact your service representative. F540 Rotor position error Software issue If errors persists, restart the instrument F541 Needle position error Needle sensor readings error...
- Page 81 Error list Rotor has been tempered with Make sure the rotor is not obstructed or moved during processing. F601 Abnormal QC Sample failed The value of the QC measurement was out of See chapter Quality Control in the manual for more range information F602...
- Page 82 Error list F640 Temperature below 18°C Ambient temperature too low Raise the ambient temperature. F641 Temperature above 28°C Ambient temperature too high Lower the ambient temperature. Temperature correction not enabled Enable Temperature correction Fan not working Contact your service representative. F642 Temperature below 15°C Ambient temperature too low...
- Page 83 Error list Warning In case of recurring error, contact your service representative. F675 ESR Report: Temperature out of range <18°C Ambient temperature too low Raise ambient temperature F676 ESR Report: Temperature out of range >28°C Ambient temperature too high Lower ambient temperature F677 ESR Report: Column height error Column height out of range...
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Page 84: 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 85: Index
Index Index About this manual......Home screen......Adding new lab users. - Page 86 Index Needle and aspiration problems....Usage options......Network tab.
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