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Installation, Operation, and Performance Qualification

Scope

This protocol defines the methods and documentation to be used for evaluating the instrument according

to the manufacturer’s specifications and intended use. Successful completion of this protocol will verify that

the instrumentation operates in accordance with intended usage.
Installation checks will be performed to verify that the Instrumentation has been installed in a proper

environmental setting, with proper connections, utilities, and reagents.
Instrument calibration will be verified.
The instrument system will be tested for proper operation of mechanical systems, menu functionality and

result reporting (display, serial output, and printer).
Performance claims will be verified (precision (within run repeatability), accuracy (linearity) and stability).
Certification of Conformance will be included.
Functional testing of instrumentation (where appropriate) will be performed to ensure system integrity.
Trained and well informed personnel will perform qualification studies.
Any exceptional conditions encountered during the qualification studies will be identified for review.

Exceptional conditions will be investigated and the appropriate course of action determined. All data will be

documented.

Instructions

This document is to be completed at the time the instrument is unpacked and set up for operation.
The individual in charge at the end user’s location should check the instrument system and perform the

various tests as outlined in this Installation, Operation, and Performance Qualification section. Each result

will be noted and dated in this section.
All deviations from normal specifications, including any problems with installation, should be noted under

COMMENTS. All solutions to such problems will also be noted in the COMMENTS section.
This document contains proprietary information and is not to be duplicated in any way without the

expressed written consent of ELITechGroup.

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Содержание FreezePoint 6000 Series

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

Страница 2: ......

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 137: ......

Страница 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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