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Elitech FreezePoint 6000 Series, User Manual

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Elitech FreezePoint 6000 Series User Manual Download Page 131

131

      Installation, Operation, and Performance Qualification

Calibration / Verification Workflow

** See 

“Accuracy (Linearity)*” on page 127

* See 

“Precision (within run repeatability)*” on page 126

Summary of Contents for FreezePoint 6000 Series

Page 1: ...FreezePoint Freezing Point Osmometer USER S MANUAL MODEL 6000 6000P 6000S 6000SP...

Page 2: ......

Page 3: ...3 FREEZEPOINT Freezing Point Osmometer MODEL 6000 6000P 6000S 6000SP USER S MANUAL 57 0022 01 C Last update 02 01 21...

Page 4: ...echGroup Inc FreezePoint is a trademark of ELITechGroup Inc Other trade names used in this manual are trademarks of their respective owners used here for information only ELITechGroup Inc makes no exp...

Page 5: ...om the actual application Other applicable documents In addition to this manual the documents included with the device documentation apply The warnings in particular safety notices in this documentati...

Page 6: ...Upper Cooling System 24 Thermistor probe 24 Lower Cooling System 24 2 4 Touchscreen 25 Enter values 26 2 5 Printer Model 6000 P SP 27 2 6 Connections and interfaces 28 Interface configuration 29 Log f...

Page 7: ...75 Align the Thermistor probe 80 Replace micro fuses 83 Clean cooling clamp 84 Replace printer paper Models 6000P 6000SP only 84 Replace printer ribbon Models 6000P 6000SP only 86 7 5 Reset device to...

Page 8: ...ication 111 Product Information 111 Table of Contents 111 Urgent Safety Information 112 Scope 113 Instructions 113 Installation Qualification IQ Verification 114 Installation of the Instrument 117 Anc...

Page 9: ...n death or serious injury if not avoided WARNING This combination of symbol and signal word indicates a potentially dangerous situation that may result in death or serious injury if not avoided CAUTIO...

Page 10: ...ns Safety notices can apply to specific individual instructions These safety notices are embedded in the instruction to avoid interrupting the flow of reading while performing the operation They use t...

Page 11: ...ns Attention when using device Only use the device to measure aqueous solutions Never measure organic saturated or highly viscous solutions Never administer measured samples to humans by infusion or i...

Page 12: ...it is not subject to stress and cannot be bent pinched or rolled over and is not exposed to liquids or heat Keep energized parts away from liquids Otherwise short circuit may occur Risk of infection...

Page 13: ...ion Obstruction of the fan outlet at the rear of the device can cause damage to the device Always keep the fan outlet clear Impact vibration WARNING Risk of property damage due to exposure of the devi...

Page 14: ...on standards Improper handling and storage of the calibration standards included with the delivery negatively affects the measurement accuracy of the device Always observe the stability of the calibra...

Page 15: ...ssible risks The user has the expert knowledge for the intended use of the device and observes all hygiene regulations for rooms used for medical purposes and the use of medical products The user know...

Page 16: ...th the device personnel must wear the personal safety gear referenced explicitly in the various sections of this manual Description of personal safety gear The personal safety gear is explained below...

Page 17: ...the environment immediately initiate suitable actions If in doubt notify the responsible local authority about the damage and inquire about suitable actions to be initiated The following environmental...

Page 18: ...front 1 Touchscreen page 25 2 Upper cooling system behind movable elevator cover page 24 3 Thermistor probe with measurement vessel page 24 4 Lower cooling system page 24 5 Elevator 6 Printer Model 6...

Page 19: ...19 Section 2 Design and Function Figure 2 Device overview rear 1 Interfaces 2 Micro Fuse compartment 3 On Off switch 4 Power cable connection 5 Fan outlet...

Page 20: ...roup Reorder consumables in particular measurement vessels and calibration standards from ELITechGroup see Manufacturer contact information on page 5 for contact information Figure 3 Overview of Consu...

Page 21: ...t Device FreezePoint Pack of 10 AC 198 2 Pipette MLA 15uL 50 ul D Tipper Silver Fixed Volume AC 199 AC 201 3 Micro Fuse Slow Blow 1 6A FreezePoint Pack of 2 RP 547 4 Adjustment Tool FreezePoint RP 546...

Page 22: ...s is determined with reference to this 2 or 3 point calibration Freezing point depression The freezing point of a solvent is depressed by adding soluble or mixable substances The magnitude of this eff...

Page 23: ...nt vessel is placed on the thermistor probe 4 and lowered into the lower cooling system 5 The lower cooling system cools the sample down to a defined temperature The defined crystallization of the sam...

Page 24: ...rature of the sample via the thermistor 2 After crystallization has been triggered the thermistor probe measures the freezing point of the sample Figure 7 Thermistor probe NOTE Sensitive component The...

Page 25: ...n The device is controlled using the touchscreen 1 WARNING Property damage due to incorrect operation The touchscreen can be damaged by sharp or hard objects or excessive pressure force Only operate t...

Page 26: ...pervisor or authorized service personnel Figure 9 1 To enter values tap the corresponding entry field in the opened menu This opens an on screen keyboard 2 Enter the value To close the on screen keybo...

Page 27: ...inter paper 2 Printer pull out handle The printer is used to print the measurement results Rolls of printer paper are included with the delivery Change printer paper Change the printer paper when a re...

Page 28: ...aces The following connections and interfaces are located at the rear of the device Figure 11 Connections and interfaces 1 COM1 only for connecting barcode reader 2 COM2 interface RS 232 output 3 USB...

Page 29: ...evice can output the recorded measurement results via the COM2 RS232 serial data port in the middle or the USB port To select the data port select Settings Lab Options Log Port The following screen le...

Page 30: ...ts the user and batch ID can be paired to a single ID The log output for the device may optionally be output in one of the following three formats Format Description Advantages Disadvantages CSV Line...

Page 31: ...rted the device sends a line with version information to prevent future compatibility problems This line contains the short name of the device type followed by the version numbers of the main board an...

Page 32: ...n value enclosed in quotation marks mOsmol kg regardless of the selected result unit and the language setting of the device Or Void if value contains an error message device no Serial number of the de...

Page 33: ...entifier entered by the user or a sequential number generated automatically Or Not present for single measurements and if batch ID is disabled in the options SampleId Sample identifier entered by the...

Page 34: ...ction is published which opens the ticket as an XML tag in the log Ticket class BATCH serialno 300201103 versions FP6000 Main VX XX COM VX X D VX XX TEC VX X If measurements are then implemented withi...

Page 35: ...es from the columns Batch ID Sample ID Date time Measurement Unit and Device number A possible result line Measurement SampleId SAMPLE01 SampleId DateTime YYYY MM DDTHH MM SS DateTime Value 299 Value...

Page 36: ...000 ea 12 Printer paper 2 rolls ea 13 Model 6000 P SP 1 User s Manual Figure 14 Delivery Condition Check the delivery for completeness and transport damage immediately following receipt Proceed as fol...

Page 37: ...proper disposal Packaging materials are valuable resources and can be reused or recycled in many cases Improper disposal of packaging materials can cause dangers to the environment Be aware of the env...

Page 38: ...atch ID of the calibration standard Biological safety Biological safety month year Date until which the calibration standard fulfills its original function if stored properly Bio hazard Bio contaminat...

Page 39: ...can become misaligned in transit and could cause inaccurate readings Align the Thermistor probe on page 80 Device Storage Store the device under the following conditions Do not store outside Store und...

Page 40: ...l is securely attached to the thermistor probe when it clicks into place Figure 15 Position measurement vessel 3 Tilt transport safety device for thermistor probe and carefully slide behind the thermi...

Page 41: ...outlet on device clear Keep fan outlet openings underneath device clear Figure 18 Fan outlet WARNING Risk of property damage Only install device indoors NOTE Risk of incorrect measurements Select site...

Page 42: ...roceed as follows Figure 20 Transport safety device 4 Carefully pull transport safety device down and pull forward to remove Figure 21 Remove transport safety device Connect device 1 Connect power plu...

Page 43: ...up device on rear side using on off switch 5 1 Check printer Models 6000P SP 5 Device does not ship with paper installed in the printer On initial set up see Replace printer paper Models 6000P 6000SP...

Page 44: ...nd fingers clear from the area underneath the initiation needle WARNING Risk of infection due to sample residue and in case of inadequate hygiene disinfection and sterilization procedures Exposure to...

Page 45: ...on settings Figure 25 Lab Options menu 2 Open the menu for configuring the lab options To configure the calibration interval tap Cal Period To select the calibration standards you are using tap Cal St...

Page 46: ...libration method 4 Select the calibration method 2 point Select 2 point calibration 3 point Select 3 point calibration 5 Select the number of measurements to be performed for each calibration medium d...

Page 47: ...digits 2020 HH Hour two digits 00 23 MM Minutes two digits 00 59 Figure 30 Set date and time Set date format 2 Select the date format required DD Day two digits 01 31 MM Month two digits 01 12 MMM Mo...

Page 48: ...ies name Set measurement series name 1 Select the name for your measurement series Figure 32 Measurement series name 5 6 Result Unit Set result unit 2 Select the unit for the measurement results mOsmo...

Page 49: ...route the power cable so it is not subject to stress and cannot be bent pinched or rolled over and is not exposed to liquids or heat Ensure easy access to the power socket at all times Keep energized...

Page 50: ...50 Section 6 Operation 6 2 Power up device Personnel User Safety gear Disposable lab gloves 1 Power up device on rear side using on off switch Figure 34 Power up device...

Page 51: ...are Display Configure screen contrast Screen saver Configure screen saver Printer Activate paper feed Model 6000P SP ID Management Set ID for sample and series measurements Figure 36 Overview of user...

Page 52: ...The following options are available Automatic The samples and the charge IDs are assigned running numbers automatically The counter resets daily The counter for the individual samples in a series mea...

Page 53: ...Options menu lets the user configure the following settings Time Date Set time and date Change Lab PIN Change PIN for access to lab options Log Port Set log port Interface configuration on page 29 Log...

Page 54: ...results Always use a clean and unused measurement vessel for every measurement Only use measurement vessels supplied by ELITechGroup Never use centrifuge tubes or reaction vessels NOTE Risk of incorr...

Page 55: ...s ready Calibration cannot be skipped The calibration interval is defined by the lab supervisor Figure 45 Calibrate device 5 Tap Measure The measurement menu opens Figure 46 Device is ready for measur...

Page 56: ...surement tap Begin Batch 3 Enter the batch ID Figure 49 Measurement menu NOTE The sample batch ID can be predefined in the user preferences In this case the system assigns the sample batch ID automati...

Page 57: ...ollowing measurement can result in carryover and incorrect measurement results Cleaning the probe with a lint free cloth wetted with DI water then wiping and drying the probe or the use of water blank...

Page 58: ...d the calibration standards used for calibration and the calibration interval are defined by the lab supervisor during start up 5 3 Set calibration defaults on page 45 Calibrate device Personnel User...

Page 59: ...and clean measurement vessel Model 6000 Model 6000P 15 L Model 6000S Model 6000SP 50 L NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample The sample must be pi...

Page 60: ...orrect measurement results Cleaning the probe with a lint free cloth wetted with DI water then wiping and drying the probe or the use of water blank may help alleviate this issue This procedure is rec...

Page 61: ...row keys and to select the calibration standard to be used Figure 60 Select calibration standard WARNING Risk of injury at ampule breaking points 12 Use the ampule opener to open the ampules containin...

Page 62: ...ter then wiping and drying the probe or the use of water blank may help alleviate this issue This procedure is recommended to avoid risk of contamination with salt at the thermistor Figure 64 Move ele...

Page 63: ...your measurements Measure individual batch samples on page 54 Note regarding 2 point calibration For a 2 point calibration the measurement accuracy of the device depends on the correct internal calib...

Page 64: ...a measurement vessel 1 on the thermistor probe NOTE The measurement vessel is securely attached to the thermistor probe when it clicks into place Figure 71 Position measurement vessel 3 Disinfect dev...

Page 65: ...imes Keep energized parts away from liquids Otherwise electrical shorts may occur Risk of infection WARNING Risk of injury due to sample residue and in case of inadequate hygiene disinfection and ster...

Page 66: ...inuous acoustic alarm In case of continuous acoustic alarm the electronics components of the device can be damaged Power down device again 3 Note down the serial number of the device Serial number is...

Page 67: ...tor of initiation needle turns without stopping Or Does not turn one full revolution Light barrier on motor disk is defective Replace light barrier Service technician Light barrier on motor disk is mi...

Page 68: ...74 Error in rotation of motor disk initiation needle drive Align initiation needle page 72 Service technician Correct length of initiation needle page 73 Check if light barrier is located properly an...

Page 69: ...l used Measurement vessel reused Only use measurement vessels supplied by ELITechGroup User Measurement vessel not positioned correctly Position measurement vessel with cover facing forward When the m...

Page 70: ...e aborted by user User moved elevator up during measurement Repeat measurement User Incorrect PIN entry Incorrect PIN entry Re enter PIN or cancel operation Lab supervisor Cannot change lab PIN or cal...

Page 71: ...ntact with the initiation needle increases the risk of infection Wear lab gloves during any kind of work DANGER Risk of death due to electrical current 1 Power down device using on off switch on rear...

Page 72: ...iation needle 5 Remove guide tube 1 and fasteners 3 of initiation needle 2 Figure 77 Initiation needle components 6 Make sure that the new initiation needle is as straight as possible 1 2 1 Incorrect...

Page 73: ...nt marker to mark the correct length and remove the needle bar again 13 Trim excess wire using side cutters and debur needle tip using precision key file Figure 79 Adjust length of initiation needle F...

Page 74: ...eedle 18 Verify free movement of initiation needle automatically Open the menu for adjusting the initiation needle Start menu Lab Options Maintenance Adjust Needle CAUTION Risk of injury from initiati...

Page 75: ...ny kind of work DANGER Risk of death due to electrical current 1 Power down device using on off switch on rear side and disconnect power plug Remove elevator cover 2 To protect thermistor cover thermi...

Page 76: ...he elevator Doing so can cause risk of instrument damage Figure 85 Move elevator cover up 5 Remove the 2 mounting screws 1 using Allen key SW 2 Figure 86 Remove mounting screws 6 Remove the complete e...

Page 77: ...mounting plate 1 Figure 91 Remove mounting plate 12 Fit new thermistor probe to mounting plate Keep the data sheet affixed to the thermistor probe 2 in the vicinity of the device To protect thermistor...

Page 78: ...ing system using tweezers 16 Remove measurement vessel from thermistor probe Figure 93 Install adjustment tool 17 Align thermistor probe Proceed as follows Push thermistor probe just beyond adjustment...

Page 79: ...using a fiberglass pin AC 200 For this purpose move elevator cover up 23 Power up device on rear side using on off switch 24 Calibrate the new thermistor probe For this purpose open the Replace Probe...

Page 80: ...rk DANGER Risk of death due to electrical current 1 Power down device using on off switch on rear side and disconnect power plug Remove elevator cover 2 To protect thermistor cover thermistor probe wi...

Page 81: ...gned using the adjustment tool 9 Install adjustment tool 1 in opening of lower cooling system using tweezers 10 Remove measurement vessel from thermistor probe Figure 105 Install adjustment tool 11 Al...

Page 82: ...ver with correct cable routing CAUTION Risk of cable break 14 Place cable 1 Above on thermistor probe in cable guide 2 Above and install elevator cover on device 15 Bolt elevator cover to elevator usi...

Page 83: ...nnect power plug 2 Open cover 1 using a flat blade screwdriver 3 Remove micro fuse attachment Figure 110 Open micro fuse cover 4 Remove micro fuses 1 from attachment CAUTION Risk of property damage Th...

Page 84: ...page 92 3 Clean cooling clamp 1 on lower cooling system using sandpaper 4 Install device front panel 8 4 Install device front panel on page 95 Figure 113 Clean cooling clamp Replace printer paper Mod...

Page 85: ...to correct feed direction of paper 6 Position knurled screw and tighten by turning clockwise 7 Power up device on rear side using on off switch Figure 117 Install Paper Roll 8 On the Start menu select...

Page 86: ...er roll 1 Power down device on rear side using on off switch 1 Paper roll 2 Ribbon Figure 120 Printer pulled out 2 Pull out printer Figure 121 Pull out printer 3 Remove printer cover Figure 122 Remove...

Page 87: ...oting 6 Feed printer paper through ribbon 7 Press ribbon onto device The ribbon snaps into place 8 Tighten ribbon by turning knob clockwise 9 Replace printer cover and push printer into casing Figure...

Page 88: ...s 1 From the Start menu select Settings Lab Options Maintenance Default Settings 2 Tap Reset to Default Settings 3 Configure the user preferences 6 3 Modify user preferences on page 51 Resetting the d...

Page 89: ...pinched or rolled over and is not exposed to liquids or heat Ensure easy access to the power socket at all times Keep energized parts away from liquids Otherwise shorts may occur Risk of infection WAR...

Page 90: ...u have questions regarding service activities and intervals contact the manufacturer Manufacturer contact information on page 5 Interval Service activity Personnel Monthly Check elevator support for e...

Page 91: ...thermistor cover thermistor probe with a measurement vessel The cover of the measurement vessel must point forward Figure 126 Position measurement vessel CAUTION Risk of thermistor damage due to loose...

Page 92: ...g so can cause risk of instrument damage Figure 128 Move elevator cover up 5 Remove the 2 mounting screws 1 using Allen key SW 2 Figure 129 Remove mounting screws 6 Remove complete elevator cover 1 Fi...

Page 93: ...he device front panel is secured to the housing by magnets CAUTION Risk of damage to cables and connectors Figure 132 Remove device front panel 9 Carefully place device front panel on its right side T...

Page 94: ...tall device front panel Figure 135 Elevator cover with correct cable routing 1 Cable Correct cable routing 2 Cable guide on thermistor probe Incorrect cable routing CAUTION Risk of cable break 5 Route...

Page 95: ...off switch 2 Remove device front panel Remove device front panel on page 91 Figure 137 Location of elevator guide 3 Lubricate elevator guide on left A and right side B of ball bearing using silicone...

Page 96: ...ecure and none of them are broken In case of cable breaks replace the cable 2 Check if foreign objects such as measurement vessels are located in the openings of the device Figure 139 Inspect device f...

Page 97: ...epeatability of measurements The purpose of the measurement check is to verify the specified performance limits of the device Sample test protocol measurement check Mechanical check Calibration verifi...

Page 98: ...ropean countries with a separate collection system for this type of equipment The symbol on the product or its packaging indicates that this product is not to be treated like regular household waste I...

Page 99: ...ring range Temperature Effects Less than 1 mOsmol kg per 5 C 9 F ambient temperature change Precision within run repeatability Models 6000 6000P Sample Volume Repeatability 0 to 400 mOsmol kg SD 4 mOs...

Page 100: ...2000 mOsmol kg Cal 0 850 2000 0 to 400 2 mOsmol kg 6 mOsmol kg 400 to 1000 0 5 1 5 1000 to 2000 1 0 Performance above 2000 mOsmol kg dependent on selection of calibration values For best results it i...

Page 101: ...1500A T 1 6 A System clock battery Type CR2032 UL MH 13654 N 10 Years Protection class IP21 Protection type I Degree of contamination 2 Serial Port RS232 2 Serial Port USB 1 Interfaces Specification...

Page 102: ...evice 10 5 Repeatability vs Reproducibility Repeatability The ability of the measuring instrument to give constant results precision in repeated tests of the same type Reproducibility The ability of t...

Page 103: ...leaning and disinfecting contaminated equipment Equipment that is strongly contaminated will not be processed by us and will be returned at the customer s expense 3 Position a measurement vessel 1 on...

Page 104: ...infection Wear lab gloves during any kind of work Figure 144 Safe Transport menu 6 Tilt transport safety device for thermistor probe and carefully slide behind the thermistor probe Figure 145 Position...

Page 105: ...FreezePoint RP 549 RS232 Cable FreezePoint RP 550 Power Cord US 120V FreezePoint RP 546 Adjustment Tool FreezePoint RP 547 Micro Fuse Slow Blow 2 ea 1 6A FreezePoint RP 572 Micro Fuse Slow Blow 10 ea...

Page 106: ...gain 3 Note down the serial number of the device Serial number is located on the rear of the device or under Settings Info 4 Have the device documentation available Figure 147 Contact ELITechGroup Con...

Page 107: ...olution with an osmotically active particle concentration of 1 Osmol kg has a freezing point of 1 858 C That means that one mole of an ideal non dissociated substance 6 023 1023 parts diluted in one k...

Page 108: ...rystallization of the sample and for undercooling the sample solution Naturally two key factors affect the measuring procedure the ambient temperature and humidity What effects can conceivably or expe...

Page 109: ...nt sample Remedy System operation 10 19 C 10 44 or artificially heated climate controlled rooms No insufficient formation of ice crystals Measurement aborts with message No crystallization Unable to p...

Page 110: ...ust be taken into account when planning serial measurements Safety Testing Summary of testing The product has been tested according to the requirements of IEC 61010 1 2010 AMD1 2016 DEKRA report no 22...

Page 111: ...Table of Contents Urgent Safety Information 117 Scope 118 Instructions 118 Installation Qualification IQ Verification 119 Installation of the Instrument 122 Ancillary Information 123 Device Environme...

Page 112: ...or probe for transport purposes Do not touch the measuring system especially the thermistor probe fitted with or without a measuring vessel until unit is powered up and self initialization You may ris...

Page 113: ...sting of instrumentation where appropriate will be performed to ensure system integrity Trained and well informed personnel will perform qualification studies Any exceptional conditions encountered du...

Page 114: ...ication Installation Qualification IQ Verification Item Date Verified Instrument and Accessories identified Manufacturer s Specifications are included User s Manual Consumables listed Purchase Order S...

Page 115: ...ment Parts on page 106 Comment Certificates Notes ELITechGroup provides the following certificates on demand SDS ELITechGroup Calibration Standards and Reference Solutions https ebs elitechgroup com S...

Page 116: ...iolation of CE requirements Such actions invalidate the compliance statement and transfer responsibility to the originator of said actions Maintenance The instrumentation listed in this document will...

Page 117: ...Instrument Identification Date Verified Manufacturer ELITechGroup Inc Model Serial Number Thermistor probe No Power 100 240 VAC Frequency 50 60 Hz Power Consumption 80 VA max Dimension W 8 1 in 205 m...

Page 118: ...o the one indicated on the back side mounted device label Is the power cord properly attached to the rear power terminal and main power supply Is the instrument placed away from direct sunlight Is the...

Page 119: ...cation Device Environment Environment Comment Date Verified Is a suitable environment given Criteria Indoor use Humidity 80 non condensing Ambient temperature 10 30 C 50 86 F Placed vibration free Dus...

Page 120: ...robustness of the process and to proof the ability to avoid approaching worst case conditions Operation Qualification Comment Date Verified Power ON Functional Tests Is the Display showing the Start M...

Page 121: ...cation Connected to RS232 USB Comment Date Verified Device is connected to PC COM port USB Port COM2 USB COM USB port specification Baud rate 9600 bits s Data format 8 data bits 1 stop bits no parity...

Page 122: ...in a fixed order Column Description user optional user ID only present if user login is activated batch Batch identifier in quotation marks or void if batch ID is disabled in the options alphanumeric...

Page 123: ...lot as long as the button is pushed Go to Start Menu Measure and measure a sample A complete protocol for one sample should be printed Go to Start Menu Measure and press Begin Charge and measure at le...

Page 124: ...not the case and the measuring vessel does not fit securely it is possible you are using an improper measuring vessel and the measurement results may not be verifiable Reused measuring vessels also ex...

Page 125: ...of 15 l or 50 l Is the personnel trained in using the pipette Volume depends on FreezePoint Model Model 6000 Model 6000P 15 L Model 6000S Model 6000SP 50 L Traceability Osmolality Check Prior to the...

Page 126: ...internally with a nearly tenth as high measuring precision related to the measuring value The measuring value is rounded up from 0 5 onwards This leads to a total deviation from the expected value The...

Page 127: ...smol kg Cal 0 850 2000 0 to 400 2 mOsmol kg 6 mOsmol kg 400 to 1000 0 5 1 5 1000 to 2000 1 0 Performance above 2000 mOsmol kg dependent on selection of calibration values For best results it is recomm...

Page 128: ...ons Osmolality mOsmol kg Standard Solutions Weight in grams of sodium chloride per kg of water Molal Osmotic Coefficient m NaCl Freezing Point Depression C T 100 3 087 0 9463 0 186 200 6 260 0 9337 0...

Page 129: ...te the system using ELITechGroup calibrators and reference solutions to demonstrate the operation The service engineer is not expected to be able to provide application support with the customer sampl...

Page 130: ...O Standard CAL1 mOsmol kg Lot No Standard CAL2 mOsmol kg Lot No Solutions for comparative measurements Reference Solutions One or more reference solutions Calibrators Reference solutions on page 128 s...

Page 131: ...131 Installation Operation and Performance Qualification Calibration Verification Workflow See Accuracy Linearity on page 127 See Precision within run repeatability on page 126...

Page 132: ...sel holder thermistor probe There will be a slight resistance and you will hear a click when the vessel is in place 4 Push the vessel holder down into the measuring position There will be a noticeable...

Page 133: ...the selection in Quality Assurance Preset optional or obligatory Purpose Linearization and fixing of instrument s CAL2 point Method A Choose the osmolality of the standard by pressing the or button u...

Page 134: ...he nominal value of CAL2 by more than the same criterion The calibration needs to be repeated if either comparison does not meet the specified criterion 6 Verification Procedure Check of Accuracy Purp...

Page 135: ...EF2 CAL mOsmol kg Pure water Sample mOsmol kg Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6 Sample 7 Sample 8 Sample 9 Sample 10 Statistics Mean value mOsmol kg SD mOsmol kg CV Record expected...

Page 136: ...s recommended Routine maintenance is not considered repair Revalidation timeline depends also on operation conditions of the instrument may be regulated by local authorities and or by the internal reg...

Page 137: ......

Page 138: ...www elitechgroup com info elitechgroup com ELITechGroup Inc 370West 1700 South Logan Utah 84321 8212 800 435 2725 1 435 752 6011 REF 57 0022 01C...

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