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Appendix D:

Regulatory Notices

OsmoPRO MAX Automated Osmometer User Guide

Date Manufactured

Flammable

Use By; Expiration Date

Lot Number

For In Vitro Diagnostic Use

Potential Puncture Hazard

Serial Number

Keep Dry

Biohazard

Catalog Number

See Instructions

Static Discharge

Manufacturer

Non-Sterile

Corrosive

Keep Hands Clear

Authorized Representative

May cause less serious health
effects, ozone layer damage

Health Hazard

Laser Hazard

Do Not Stare Into Laser Beam

Sufficient for [x] Tests

Содержание OsmoPRO

Страница 1: ...OsmoPRO MAX Automated Osmometer User Guide 552955EN Rev 0 ...

Страница 2: ...nts The following are trademarks of Advanced Instruments LLC OsmoPRO Protinol Renol Clinitrol AdvancedQC WARNING Employees of Advanced Instruments have reviewed this guide thoroughly Although material contained within is believed reliable the accuracy and completeness are not guaranteed or warranted and are not intended to be representations or warranties concerning the product described Screensho...

Страница 3: ...ompleting the Test 51 Chapter 6 Viewing Test Results and System Data 53 6 1 Viewing Results 53 6 2 Filtering the Results List 54 6 3 Exporting Results 55 6 4 Uploading Results to the LIS Server 55 6 5 Uploading QC Tests to the AdvancedQC Peer Group Program 56 6 6 Configuring Data Management 57 Chapter 7 Running Instrument Calibration 59 7 1 When to Calibrate the Instrument 59 7 2 Calibrating the I...

Страница 4: ...ics 80 Appendix B Product Specifications 82 Appendix C Known Limitations 83 Appendix D Regulatory Notices 84 Appendix E OsmoPRO MAX LIS Specification 86 Appendix F User Access Quick Reference 92 Appendix G Product Disposal and Recycling 95 Appendix H Warranty and Warranty Duties 96 ...

Страница 5: ... aicompanies com Customer Service Orders Phone US or Canada 800 225 4034 from 8 00 AM 4 30 PM Eastern time Outside US or Canada 1 781 320 9000 Email orders aicompanies com Technical Service Phone US or Canada 800 225 4034 from 8 00 AM 4 30 PM Eastern time after normal business hours follow prompts Outside US or Canada 1 781 320 9000 Email techsupport aicompanies com Contacting Advanced Instruments...

Страница 6: ...ailable Separately Item Part OsmoPRO MAX Convenience Kit SKC PRO MAX Includes the following products OsmoPRO MAX Maintenance Kit 500 Tests OsmoPRO MAX System Fluid 230mL OsmoPRO MAX Enzymatic Cleaner 1 3mL OsmoPRO MAX Peristaltic Tubing Lines 2 tubing lines MAX500 OsmoPRO MAX Calibration Set qty 2 One 2mL ampule each of 0 300 850 and 2000 mOsm kg calibration standards four total One ampule opener ...

Страница 7: ...ting samples to verify instrument operation and confirm calibration After performing a recalibration 1 CAP Chemistry Checklist revised 7 28 2015 CHM 13900 Daily QC Nonwaived Tests Verifying Linearity Use our Osmolality Linearity Set to verify your instrument s linearity and reportable range and after recalibrating Strengthen your laboratory s Quality Control program by using products made specific...

Страница 8: ...t unnecessary recalibration can introduce inaccuracy The calibration of a freezing point osmometer in good condition and properly operated will not shift or drift Follow the quality control requirements of your associations and regulatory bodies Advanced Instruments recommends the following usage schedule of quality control materials to ensure proper instrument operation result reporting and Good ...

Страница 9: ...Quality Control OsmoPRO MAX Automated Osmometer User Guide 9 The following flowchart illustrates the recommended daily procedure ...

Страница 10: ...Osm kg Calibration Standard Standard deviation 2 mOsm kg H2O 98 102 96 104 94 106 300 mOsm kg Calibration Standard Standard deviation 2 mOsm kg H2O 298 302 296 304 294 306 500 mOsm kg Calibration Standard Coefficient of variation 0 5 497 503 494 506 491 509 850 mOsm kg Calibration Standard Coefficient of variation 0 5 845 855 840 860 835 865 900 mOsm kg Calibration Standard Coefficient of variatio...

Страница 11: ...boratory work Original spare parts and tools made or recommended by Advanced Instruments Good Laboratory Practice GLP Accident prevention regulations published by the accident insurance companies for laboratory work Power cable Defective power cables are not to be used to connect the instrument and the power supply system Power strip If several instruments are connected to one power strip always c...

Страница 12: ...sion cord or power strip is used make sure that the cord or strip is rated for the product and that the total ampere ratings of all products plugged into the extension cord or strip do not exceed 80 of the cord or strip rating limit Route power cords so that they will not be walked on tripped on or pinched by items placed upon or against them Pay particular attention to the plug electrical outlet ...

Страница 13: ...tilisateur d utiliser l équipement This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 This device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Le présent appareil est conforme aux CNR d Industrie Canada applicables aux appa...

Страница 14: ...gs for instructions on using any of the data management features mentioned in this chapter 1 3 Principles of Freezing Point Osmometry When a solute is dissolved in a pure solvent the following changes in the solution s properties occur The freezing point is depressed The boiling point is raised The osmotic pressure increases The vapor pressure decreases These are the so called colligative or conce...

Страница 15: ...ost precise way to measure the freezing point of a solution is to supercool it to several degrees below its freezing point and then induce freezing The solution is in a quasi stable condition in this state At this point a separate thermal element is used to induce crystallization The sudden liberation of the heat of fusion causes the sample temperature to rise rapidly toward a plateau temperature ...

Страница 16: ...by preventing air from being pulled into the fluidics lines CAUTION Use of other types of cleaning fluids or water may not properly clean the system and may affect the test results of future samples due to carryover or dilution effects E USB Type A port This single port on the right side is convenient for connecting USB peripherals such as a barcode scanner keyboard or mouse F Turntable containing...

Страница 17: ... touch access to major system functions displays informative system prompts directing operators to the next step in a workflow and displays visual notifications on the status of various system operations system fluid remaining test in process warnings error conditions etc See also User Interface Overview ...

Страница 18: ...cm of clear space on each side of the instrument in order to access the peristaltic tubes on the left side and the power switch and connectors on the rear of the instrument Allow 6 inches 15 cm of clear space behind the instrument in order to freely connect and disconnect the power cord and for fan driven air circulation Do not block airflow from the exhaust fan on the back panel or underneath the...

Страница 19: ...dy upright so your legs do the lifting rather than your back Look straight ahead and keep your back straight and shoulders back so you have a slight arch in your lower back 4 From the rear of the instrument reach your arms around each side of the instrument so each hand is on the bottom front of the instrument 5 Get a good grip on the instrument and lift it from the box using your legs 6 If a cart...

Страница 20: ...the rear panel down slightly and then pull it away from the instrument Remove the Shipping Stop Required Medium sized Phillips screwdriver The shipping stop B is shown below It is secured with a Philips head screw C B 1 Unscrew the Philips head screw 2 Gently push the shipping stop forward approximately 1 2 5 cm to gain clearance 3 Rotate the shipping stop to the left so that it clears the linear ...

Страница 21: ...the turntable with one hand while turning the knurled turntable locking screw fully clockwise with the other hand to lock the turntable on the drive spindle Make sure it is secure but do not over tighten 2 Slowly push the turntable forward and turn slightly until it aligns and drops down over the spindle 3 Hold the turntable s outer edge and turn the locking screw fully clockwise to lock the turnt...

Страница 22: ...ter or a handheld barcode scanner are to be used connect the cables to any of the USB ports located on the front or rear B of the instrument 2 5 Setting Up the Instrument Powering Up 1 Connect the power cord into the instrument power connector and plug the cord into a power outlet see Rear Power Module 2 Turn the power switch ON The splash screen displays while the system starts up The Home Screen...

Страница 23: ...return to the Home screen 4 Press on the Home screen to open the Main menu 5 Press Diagnostics to open the Diagnostics menu 6 Press to return to the Home screen Several set up tasks are done using the Settings menu and Diagnostics menu options Logging in to the Admin User Account Many functions on the Main menu and other system menus require a supervisor level user to log in order to access them T...

Страница 24: ...ve 4 Press Exit to return to the Settings menu 5 Power off the instrument wait 15 seconds and then power on the instrument Set the System Date and Time Your instrument has a built in real time clock RTC to keep track of the current date and time NOTE Access to Settings Date Time depends on the Change Date Time checkbox setting on the Operator Permissions tab see Configure Operator Permissions To c...

Страница 25: ...Installation Date required from the calendar Make sure you select the correct date You cannot change the installation date once it is saved 5 Press OK 6 Press Edit to type a Comment required up to 1024 characters to enter the operator who set the installation date and any other information pertaining to the installation 7 Press Save 8 Press Exit to return to the Diagnostics menu 9 Press to return ...

Страница 26: ... disinfect the waste bottle using 1 hypochlorite solution2 after emptying the it 2 Commercial bleach with 8 25 sodium hypochlorite diluted to 1 with water 2 Position the waste bottle in the rear recess to the left of the turntable 3 Press Next Install the Peristaltic Tubing Lines Complete the following steps to install the tubing line for each peristaltic pump 1 Press to view the onscreen instruct...

Страница 27: ...uid bottle and dispose of the cap NOTE For subsequent System Fluid bottle replacements dispose of the bottle according to established laboratory procedures The System Fluid bottle contains residual fluid at the time of replacement This is intended to maintain optimal instrument performance by preventing air from being pulled into the fluidics lines 2 Insert the System Fluid tubing into the bottle ...

Страница 28: ... vial in the adapter 4 Press Clean The cleaning cycle takes approximately 10 minutes to complete 5 When the fluidics cleaning is complete remove the adapter and vial from the turntable 6 Dispose of the vial according to the disposal instructions in the Safety Data Sheet 7 Press Done to return to the Home screen The turntable is unlocked and the system fluid indicator on the Home screen indicates t...

Страница 29: ... Press Exit to return to the Settings menu Configure Testing Access and Replicates Authorized users can configure the system to require users to enter a user ID and or a sample ID before testing can start 1 Press Settings H W Options and log in Settings Configuration Testing 2 Select the User ID checkbox to require users to enter a user ID before testing 3 Select the Sample ID checkbox to require ...

Страница 30: ...t frequency Never If you select 8 hrs or 24 hrs you can also select the Lock instrument when QC checkbox When this checkbox is selected the system prompts the operator before testing if the selected time period has elapsed without Clinitrol testing see Testing Samples 6 Press Save Configure Timeouts You can set the instrument to automatically log out and or dim the screen after a set time of inact...

Страница 31: ...pen the Add New User screen 3 Press next to the ID field 4 Type the ID and press Enter 5 Enter the Password and Access Level in one of these ways If Badge Scan Mode is enabled see Configure the Login Mode CAUTION The front barcode scanner uses a Class 2 laser Do not stare directly into the beam when scanning barcodes a Scan your badge using the front barcode reader by aligning the barcode with the...

Страница 32: ...4 Change the user Password and Access Level as needed NOTE You cannot edit the user ID 5 Press Save 6 Press Exit to return to the Settings menu Deleting a User To delete a user complete the following steps NOTE The Admin and Service user accounts cannot be deleted 1 Press Settings Users and log in to the Admin account see Logging in to the Admin User Account 2 Press to select a user on the Users s...

Страница 33: ...Laboratory Information System LIS you can configure the OsmoPRO MAX to communicate with it The OsmoPRO MAX can function either as a client or server with a LIS and communication can be set to undirectional or bidirectional Bidirectional mode Users can configure the instrument to expect download of sample work orders from the LIS In this mode 1 The Instrument receives work orders at any time and st...

Страница 34: ...link becomes disconnected the results are stores as Pending LIS indicated by a number in the LIS indicator circle When the link is restored the data is sent and there is no indicator number Manually Accumulates test results in the Results database until a user selects to send it to the LIS from the Results screen Configure the Peer Group Connection AdvancedQC is a free web based peer group program...

Страница 35: ... shows active power off the instrument and wait 15 seconds b Power on the instrument c If you still cannot connect to the AdvancedQC Peer Group Program from the Peer Group tab contact AI Service see Contacting Advanced Instruments Change Hardware Options You can change the system audio screen brightness and barcode scanner settings NOTE Access to Settings H W Options depends on the Change Hardware...

Страница 36: ... a Class 2 laser Do not stare directly into the beam when scanning barcodes The front barcode scanner supports the following barcode types Code 39 Code 128 ECC UPC GS1 Codabar Code 93 Code 11 Interleaved PDF417 MSI QR IATA MaxiCode Aztec EAN To enable disable the front barcode scanner and change the scanner brightness 1 Press Settings H W Options and log in 2 Press the Front Barcode tab 3 Press En...

Страница 37: ...ge the inactivity interval see Configure Timeouts 3 3 The Home Screen Use the Home screen to Set up and run an automated test see Starting an Automated Test View the progress and results of each test see Testing in Progress Perform a STAT test of a sample during automated testing see Running a STAT Test Open the main menu see Main Menu Button View information on Current warnings and alarms generat...

Страница 38: ...see Load the Maintenance Kit An error occurred and the system generated an alarm Testing and calibration cannot be performed until the issue is resolved Press to display the alarm s see Warning Alarm Icons Troubleshooting C Test Results Lists each test result when the test completes Also displays the system date and time D Screen Capture Press to capture the current screen to a USB drive E Main Me...

Страница 39: ...s Icons and Testing Buttons Press to open the LEGEND screen which explains each status icon Icon categories are divided into the Testing Indicators System Fluid LAN LIS Access levels and tabs Testing Tab Press the Testing tab for information on the following icons buttons that appear when testing turntable tubes During testing it indicates which tube positions contain Unused untested sample or no ...

Страница 40: ...m Fluid Tab Press the System fluid tab for information on the system fluid icon on the Home screen This icon indicates the umber of tests remaining in system based on system fluid level Ready Sufficient fluid is available for the displayed number of tests Low Fewer than 100 tests remain based on system fluid contents Empty Load new system fluid into system see Instrument Maintenance LAN LIS Tab Pr...

Страница 41: ...information LAN Tab Press the LAN tab to view network information System History Tab Press the System History tab to view instrument history information 3 4 The Main Menu The main menu gives you access to the main functions of the system Press MENU on the Home screen to open the main menu 3 5 Operating the OsmoPRO MAX The following chapters explain how to perform tests automated and STAT from the ...

Страница 42: ...r the ID manually you also must enter the following information manually by pressing next to each field Control Name Lot Number Expiration Date NOTE Expiration dates on Advanced Instruments controls include the month and year The system requires the day Use the last day of the month as the expiration day Nominal Value Lower and Upper values of the standard deviation range 4 If another lot of the c...

Страница 43: ...em you can add delete and select the default lot for the system to use when testing Adding a Control Lot To add a lot to a control 1 Press Controls Log and log in 2 Press to select a control on the Controls Log screen 3 Press Lots 4 Press Add 5 Scan in the UDI barcode using the front barcode scanner by aligning the barcode with the barcode laser CAUTION The front barcode scanner uses a Class 2 las...

Страница 44: ...the default Press Yes to make the new control lot the default for the control Press No to keep the current lot as the default 8 Press Exit to return to the Settings menu Deleting a Control Lot 1 Press to select a control on the Controls Log screen 2 Press Lots 3 Select the control lot to delete You cannot delete the default control lot 4 Press Yes to permanently delete the control lot from the sys...

Страница 45: ... screen 4 4 Displaying and Exporting a Levey Jennings Chart Your instrument can generate Levey Jennings charts for controls with standard deviation SD bands To generate a chart the control must be entered in the controls database 1 Press to select a control on the Controls Log screen 2 Press Chart 3 Select 1 2 or 3 SD Bands 4 Select a date range using the Min and Max calendars 5 Press Export to ex...

Страница 46: ...strongly recommended to ensure optimal performance and maximize the life of the instrument 5 1 Best Practices for Handling Samples Verify calibration daily using Advanced Instruments controls see Running Instrument Calibration and Quality Control The turntable holds up to 20 samples to be tested The instrument is designed to acquire samples from the following glass or plastic tubes 75mm to 100mm i...

Страница 47: ... used cannot exceed 100 mm to avoid the pipettor striking the top of the insert and causing damage to the instrument and or the primary tube For best performance when using small volume insert tubes it is recommended that they be placed in a 75 mm tall tube The following tables specifies the minimum volumes required in typical sizes of sample tubes to test one sample while ensuring proper operatio...

Страница 48: ...ptable manner in compliance with all country state and local requirements IMPORTANT Do not test samples until controls and or reference solutions yield values in the expected range 5 2 Pre testing Checklist Before initiating a test sequence complete the following tasks 1 Configure testing access if you want user IDs and or sample IDs required to run a test see Configure Testing Access and Replicat...

Страница 49: ...strument lock and log in to a Supervisor level account Press No to cancel the test until the instrument calibration has been verified with Clinitrol see Verifying Calibration with a Quality Control Test Once any Quality Control requirements have been met the system checks all positions on the turntable for samples and automatically selects all filled positions on the turntable display NOTE Press a...

Страница 50: ...y containing a sample If required log in before loading more samples NOTE If you stop loading tubes for more than two minutes the instrument prompts you to continue loading If you do not respond within 30 seconds the instrument cancels all loading and marks the loaded tube positions as empty 3 Add the samples to the selected turntable position s 4 Press to resume testing The sample is scanned into...

Страница 51: ...t cancels all loading and marks the loaded tube positions as empty The system completes the test in progress 4 Press Testing begins on the STAT sample 5 Once the STAT test is complete the result is displayed with the automated test results STAT test passed STAT test failed The automated test sequence resumes where it left off once the STAT test is complete 5 6 Completing the Test The instrument co...

Страница 52: ...tomated Osmometer User Guide 52 If you are done testing press to clear the turntable display The test information clears from the Home screen All results are saved to the Results database in the system see Viewing Test Results and System Data ...

Страница 53: ... results records selected Press this icon to deselect all selected record D Press to expand result records in the list that contain more than one line of information E Press to filter records in the results list see Filtering the Results List F Shows the number of records displayed and the total number of results records in the system To change the number of records loaded into the list a Press an...

Страница 54: ...et of results 1 From the Results screen press to display the Filter screen 2 Press to enter filter criteria in one or more parameter fields Sample ID Press the keyboard icon and enter a sample ID User ID Select from drop down list Signatures Select from drop down list Date Range Press to select the start and end dates Test Details Press and enter text that identifies a test Use the asterisk wildca...

Страница 55: ...n the records to export see Filtering the Results List For example entering stat under Test Details filters out all results records except those that have the string STAT to return all STAT test If no records are filtered and or selected the system exports all result records that are showing If the results database exceeds 100 records increase the number of records loaded in the list see Viewing R...

Страница 56: ...l and Renol results to the AdvancedQC Peer Group Program Refer to Using the Controls Log Database Configure Quality Control Actions 1 From the Results screen press to display the Filter screen 2 Enter search criteria in the search fields For example Press next to Sample ID and enter protinol in the field 3 Press Search The system returns all quality tests conducted using Protinol 4 Select the reco...

Страница 57: ...anagement screen provides access to Supervisor level utilities From here Supervisors can enable disable the exporting test results from the Results screen and the exporting of system events from the Diagnostics Events screen Supervisors can also exports results events users and control logs data stored on the instrument in CSV format to a USB drive The Data Management screen is available only to S...

Страница 58: ...d on the instrument in CSV format to a USB drive complete the following steps 1 Insert a USB drive into a USB port on the instrument 2 Press Settings Data Management and log in 3 Use the radio buttons to select the database table you want to export 4 Press Export Repeat steps 3 and 4 for other database tables you want to export 5 When you are finished press Exit to return to the Settings menu ...

Страница 59: ...aily to verify the calibration The instrument is serviced or its hardware replaced Calibration is required based on laboratory regulations NOTE Calibration is not required after replacing the OsmoPRO MAX Maintenance Kit 7 2 Calibrating the Instrument NOTICE Read and follow these calibration instructions carefully Testing calibration standards out of order results in a calibration failure Required ...

Страница 60: ...icated on the screen c Open one 2 mL vial each of 2000 850 300 and 0 mOsm kg H2O calibration standards d Place each standard in the turntable position indicated on the screen NOTE Canceling calibration You can cancel the calibration at any time by pressing Exit The last successful calibration data remains Performing Calibration Before starting the calibration make sure that the standards and contr...

Страница 61: ...he expected ranges After recalibrating re run the reference solutions and controls to verify that you obtain the expected results We recommend using Clinitrol 290 Reference Solution Protinol Protein Based Serum Controls and Renol Urine Osmolality Controls Use these reference solutions and controls Daily prior to testing samples to verify instrument operation and confirm calibration After performin...

Страница 62: ...d contamination Preparing the Controls 1 Allow one vial of each level of Protinol Protein Based Controls and Renol Urine Osmolality Controls to come to room temperature Protinol 240 mOsm kg H2O Protinol 280 mOsm kg H2O Protinol 320 mOsm kg H2O Renol 300 mOsm kg H2O Renol 800 mOsm kg H2O 3 Prior to each use mix the contents of the vials by gently swirling Do not shake the controls or allow them to ...

Страница 63: ...ice representative will provide you with an RMA number Units are not accepted for service without an RMA number 8 2 ESD Precautions A discharge of static electricity from contact with the human body or other conductor can damage system boards or static sensitive devices Never perform internal maintenance without following recommended electrostatic discharge ESD protection procedures 8 3 Shutting D...

Страница 64: ...tions to Load the Maintenance Kit Replacing the Peristaltic Pump Tube Linings Required materials OsmoPRO MAX Peristaltic Tube Linings included with the OsmoPRO MAX Maintenance Kit The OsmoPRO MAX Peristaltic Tube Linings consist of two lengths of tube complete with tube clips and barb connectors Complete the following steps to replace the peristaltic pump tubing for each peristaltic pump 1 Press t...

Страница 65: ...ngs have been replaced press Next 8 6 As Needed Priming the Pipettor The instrument cleans the fluid lines automatically during the test sequence However it is recommended to run a cleaning cycle If the instrument has sat idle for a week or more If poor precision is observed In the unlikely event that the instrument System Fluid runs dry Use the Cleaning function on the Diagnostics menu to prime t...

Страница 66: ... box 6 Press Exit to return to the Diagnostics menu Logging Preventative Maintenance Supervisors only Supervisor level users can record when preventative maintenance is performed and the service engineer performing the maintenance IMPORTANT Annual preventative maintenance by an Advanced Instruments trained service engineer is strongly recommended to ensure optimal performance and maximize the life...

Страница 67: ...repaired and the service engineer performing the repair by completing the following steps 1 Press Diagnostics Maintenance and log in 2 Press the Repairs tab 3 Press to enter the Advanced Instruments trained service engineer name required who repaired the instrument 4 Press Edit to type a Comment required up to 1024 characters to explain the repair s performed 5 Press Save 6 Press Exit to return to...

Страница 68: ... and save to the events database 1 This function is covered in Instrument Maintenance 9 2 Testing the Analog to Digital Converter Use the A D feature to test the analog to digital converter A D sample probe block probe cooling assembly and the efficiency of heat transfer between the cooling assembly components Results are presented as resistance ohms temperature C and power level 1 From the Home s...

Страница 69: ...ld be the same as the 33K gold values 6Ω Readings outside this range might point to issues with the A D see Contacting Advanced Instruments for service contact information 7 Press Exit to return to the Diagnostics menu 9 3 Testing the Assurance Tag Reader Use this screen to test the assurance tag reader used to load and track maintenance kits and calibration kits in the system 1 From the Home scre...

Страница 70: ...er Do not stare directly into the beam when scanning barcodes 5 Scan the barcode of an OsmoPRO MAX Maintenance Kit Calibration Kit or calibration standard on the front barcode reader 6 If successful you hear a beep and the barcode information appears 7 Press Exit to return to the Diagnostics menu The front barcode scanner supports the following barcode types Code 39 Code 128 ECC UPC GS1 Codabar Co...

Страница 71: ...selected event records to a USB drive in the configured file format s see Diagnostics IMPORTANT If the Export button is disabled make sure the Data Export Enabled checkbox on the Settings Data Management screen is selected see Configuring Data Export of Results and Events Filtering the Events List To make the events list more manageable you can filter the results to display only a subset of result...

Страница 72: ...e Diagnostics menu 9 8 Testing the Printer Connect an external printer to enable the printer test see Supplies Standards and Controls 1 Press Printer 2 Press Test to initiate a print test of all alphanumeric characters A Status of READY indicates the printer is working properly 3 Press Exit to return to the Diagnostics menu 9 9 Testing the Instrument Motors and Sensors This function tests all inst...

Страница 73: ...utomated Osmometer User Guide 73 2 Select a motor or sensor test and press Test Repeat this step for each sensor and motor that you want to test NOTE Press STOP at any time to stop the test 3 Press Exit to return to the Diagnostics menu ...

Страница 74: ...2 Issues that Require a Service Technician If the product requires service for any of the following reasons unplug the product from the electrical outlet and refer service to a qualified service technician The power cord extension cord power strip or power input module is damaged Liquid has spilled into the interior of the product A foreign object has fallen into the product The product has been d...

Страница 75: ...plug the instrument and remove the power cord from the instrument 3 Locate the fuse holder A on the rear of the instrument A 4 Use a small flat screwdriver B to open the fuse box on the rear B 5 Use the screwdriver and pliers if needed to remove the fuse holder and the two fuses Replacing the Fuses 1 Insert two replacement fuses into the fuse holder Use Fuse Replacement Kit p n 70022R contains two...

Страница 76: ...ssue make no further attempts to resolve the issue Instead contact the Advanced Instruments Service Department US or Canada 800 225 4034 from 8 00 AM 4 30 PM Eastern time after normal business hours follow prompts Outside US or Canada 1 781 320 9000 Email techsupport aicompanies com General Use Errors The following table lists error messages operators could encounter while operating the instrument...

Страница 77: ...d action Temperature and humidity not detected 68 Cause Issue reading and writing to sensor Action Reboot instrument If problem persists after reboot contact AI Service Power supply error motor board 69 Cause Error on 3 3 V ADC sensor Action Reboot instrument If problem persists after reboot contact AI Service Comm error 92 Cause Cable issue Action Check cable Cause Bad scanner Action Reboot instr...

Страница 78: ... If cable connection is good and problem persists after reboot contact AI Service Assurance tag reader error 101 Cause Cable RX or TX Action Check cable Cause Bad assurance tag reader Action Reboot If cable connection is good and problem persists after reboot contact AI Service Assurance tag reader not connected 102 Cause Cable RX or TX Action Check cable and reboot If cable connection is good and...

Страница 79: ...mpletion if one or more of these errors occurs depending on the QC action set see Configure Quality Control Actions These errors are also recorded on the printout and stored in the Events database If sample test related warnings occur that the operator cannot troubleshoot resolve call Advanced Instruments Technical Service Possible sample test errors Sample Did Not Freeze Sample Pre Freeze Test Ti...

Страница 80: ...curacy against AI nominal value tested at a minimum of 30 relative humidity and 20 C to 25 C environmental conditions 95 of the individual replicate values of salt solutions shall be 1 0 two 2 times the Coefficient of Variation from nominal values between 400 and 1500mOsm kg H O 95 of the individual replicate values of salt solutions shall be 1 5 two 2 times the Coefficient of Variation from nomin...

Страница 81: ...H1 3 followed by 5 replicates of the low sample of 50 mOsm L1 5 for a total of eight replicates Where K is defined as K L1 avg L3 5 avg H1 3 avg L3 5 100 Where K L1 avg L3 5 avg H1 3 avg L3 5 100 avg L3 5 is the average of the 3rd 4th and 5th replicate of the low osmolality sample avg H1 3 is the average of the 1st 2nd and 3rd replicate of the high osmolality sample The 0 31 K corresponds to a 6 m...

Страница 82: ... 2 0 Amp Memory capacity 1 000 results 10 000 events Memory backup Integral lithium cell 10 year life unpowered not user replaceable Classifications Protection class I Over voltage category II Pollution degree 2 Moisture protection IPX0 ordinary Communication USB 2 0 Type A ports 3 USB 2 0 Type B port 1 Ethernet 10 100 Operating conditions Temperature 18 C to 35 C 64 F to 95 F Humidity 5 to 80 rel...

Страница 83: ...ect of evaporation on the osmolality of the sample can vary widely depending on ambient conditions duration sample volume and sample type Only use uncapped tubes to process tests on the instrument Capped tubes may damage the instrument Additives such as anticoagulants from collection tubes may contribute to the measured osmolality Non aqueous and highly viscous solutions will not yield accurate re...

Страница 84: ...his instrument or in the accompanying documentation This symbol indicates conformity to relevant European directives This symbol indicates the product was tested to conform to relevant Canadian and U S safety standards by Intertek Testing Services NA Inc The ETL mark is approved in the United States as a Nationally Recognized Testing Lab NRTL by OSHA and in Canada by the Standards Council of Canad...

Страница 85: ...n Vitro Diagnostic Use Potential Puncture Hazard Serial Number Keep Dry Biohazard Catalog Number See Instructions Static Discharge Manufacturer Non Sterile Corrosive Keep Hands Clear Authorized Representative May cause less serious health effects ozone layer damage Health Hazard Laser Hazard Do Not Stare Into Laser Beam Sufficient for x Tests ...

Страница 86: ...ansfer available results to the host or to manually transfer results to permit the operator time to review the data and release the samples In bidirectional mode the Instrument system can request sample work order information from the LIS when needed The LIS can also initiate sending sample work order information to the Instrument in advance of sample runs The information is parsed and stored in t...

Страница 87: ...dards Institute 2 Institute of Electrical and Electronics Engineers The only valid responses to the ENQ character are ACK ASCII decimal 6 If ACK is received the phase is complete and the initiating system becomes the sender NAK ASCII decimal 21 If NAK is received the other system is probably busy handling other requests ENQ The initiating system waits 10 seconds and tries sending ENQ again The rec...

Страница 88: ...ter The instrument as a receiver handles any other valid set of delimiters see LIS2 A2 section 5 4 The instrument does not transmit null values to indicate that the value has not changed since the last transmission and does not use received null values Any received fields not required by the instrument are ignored and are not covered in this guide The following record types are not sent by the ins...

Страница 89: ... 8 4 7 Requested ordered date and time optional Text field containing the date time of the order If the date time is in the future the system does not look for the specimen until after that date time 8 4 8 Specimen collection date and time optional Text field indicating the date time that the specimen was collected 8 4 10 Collection volume optional Text field indicating the volume of the specimen ...

Страница 90: ...er for a sample if it is not already present The LIS can use it to request results from previously measured samples The fields used in this record are as specified in LIS2 A2 11 1 Record type ID Q identifies the record as a request record 11 2 Sequence number Sequence number integer of the request 11 3 Starting range ID Text field containing the starting record to look up It can have up to three c...

Страница 91: ... 123 456 7890 Extra N CR ETX Message Terminator Record This record is used to signify the end of a message The fields used in this record are as specified in LIS2 A2 12 1 Record type ID L identifies the record as a terminator record 12 2 Sequence number Sequence number integer of the request 12 3 Termination code optional Single character indicating the status of the message See the LIS2 A2 docume...

Страница 92: ...r Osmometer user authorized to define access restrictions to operators Accessible Functions by User Access Level Key 9 Function is always accessible to these users 9 Function is accessible to these users depending on restrictions setting 8 Function is never accessible to these users Function should only be performed by an AI trained Service Technician System Functions User Access Levels Supervisor...

Страница 93: ...sample probe resistance Contact the Advanced Instruments Service Department US or Canada 800 225 4034 from 8 00 AM 4 30 PM Eastern time after normal business hours follow prompts Outside US or Canada 1 781 320 9000 Email techsupport aicompanies com Alignment align motors and front barcode scanner Networking Configure LAN settings Configure LIS settings Configure AdvancedQC settings 9 9 Configurati...

Страница 94: ...ed Export system event data 9 9 Maintenance 9 9 Record pipette cleaning and peristaltic tubing and waste bottle replacement 9 9 Perform and record instrument preventative maintenance 9 8 Perform and record instrument repairs Enter the instrument installation date Controls Log screen Using the Controls Log Database Add a control Add a control lot Assign the default lot for a control Delete controls...

Страница 95: ... identifying the options available to you once the decision has been made to replace or dispose of this product Contact the supplier who sold you the product Whether you purchased the product from Advanced Instruments or from one of its authorized dealers this supplier should be knowledgeable about the national and local regulations governing disposal and recycling of products in your area In some...

Страница 96: ...e include any obligation or responsibility for transportation charges or arrangements All results calibrations effectiveness checks and interpretations are the responsibility of the user THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES REPRESENTATIONS AND CONDITIONS OF ANY KIND EXPRESSED OR IMPLIED IN FACT OR BY LAW IN NO EVENT SHALL ADVANCED INSTRUMENTS BE LIABLE UNDER THIS WARRANTY OR OTHERWISE ...

Страница 97: ...ants that 1 The instrument will be used reasonably 2 The instrument will be regularly maintained according to this manual including a log of all service tests and repairs performed on the equipment and records will be kept of all requests for repair made to Advanced Instruments where such repairs were beyond the ability of local service personnel 3 The instrument will not be altered without writte...

Страница 98: ...plied by Advanced Instruments assuming English reading personnel or supervision If neither the supervisor nor the operator reads English the user agrees to obtain accurate translations of the instrument labels instructions user guides and or manuals provided Under direct on the job supervision of the supervisor or other professional in charge In which there are no known defects or uncorrected repa...

Страница 99: ...eserved Under copyright laws this guide may not be reproduced in any form in whole or part without the prior written consent of Advanced Instruments 2022 Advanced Instruments LLC OsmoPRO is a trademark of Advanced Instruments LLC All other trademarks are the property of their respective companies Advanced Instruments LLC 2 Technology Way Norwood Massachusetts 02062 USA 800 225 4034 781 320 9000 ww...

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