Advanced Instruments OsmoPRO Multi-Sample User Manual Download Page 86

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OsmoPRO® Multi-Sample Micro-Osmometer User’s Guide

G - Symbol definitions

The below list of symbols is for reference only. Not all symbols shown may be used on this

instrument or in the accompanying documentation.

Protective

Earth Ground

Fuse

Alternating

Current (AC)

On-Off

Functional

Arrow

Feed

Printer

Interrupt

Enter

Test

RS232

Start

Bar Code

Stop

Attention

Record

Review

Caution Hot

Surface

Setup

Dangerous

Voltage

Calibration

Lifting

Hazard

Cancel;

Delete

Calibrator

Content

Do Not Open

Top

Control

Handle with

Care

Negative

Control

Toxic

Use Blade to

Open

Positive

Control

Flammable

Do Not Re-

Use

Fragile

For In Vitro

Diagnostic Use

Irritant

European

Conformity

Keep Dry

Temperature

Limit

Date

Manufactured

See

Instructions

Sterile

Lot Number

Non-Sterile

Use By;

Expiration

Date

Serial

Number

Authorized

Representative

Solution

Part Number

Sufficient for

[x] Tests

Latex-Free

Summary of Contents for OsmoPRO Multi-Sample

Page 1: ...OsmoPRO Multi Sample Micro Osmometer User s Guide 112005EN Rev3 ...

Page 2: ...nol Advanced Instruments reviewed this guide thoroughly All material contained within is believed reliable but the accuracy and completeness are not guaranteed or warranted and are not intended to be representations or warranties concerning the product described Hot Line Technical Service For any questions or problems regarding the proper operation of the instrument contact the Hot Line Technical ...

Page 3: ...iew 20 2 1 Intended use 20 2 2 Principles of freezing point depression 20 2 3 Definitions 22 3 System operation 25 3 1 Main screen 25 3 2 Legend information 26 3 3 Assistance information 26 3 4 Main screen navigation 28 4 Testing and calibration 29 4 1 Testing loading samples with turntable installed on instrument 30 4 2 Testing loading samples with turntable removed from instrument 32 4 3 Cancell...

Page 4: ...7 9 Service 58 7 10 Restrictions 60 8 Diagnostics 61 8 2 Motors 62 8 3 Sample probe 64 8 4 Barcode 64 8 5 Events 65 8 6 Printer 67 8 7 LCD 68 8 8 Solenoid 69 8 9 Cleaning 69 9 Troubleshooting and service 70 9 1 Routine maintenance 70 9 2 Troubleshooting 71 A Product specifications 76 B Performance characteristics 77 C Known limitations 78 D Regulatory notices 79 E Warranty warranty duties 82 F Sup...

Page 5: ...e presence of important operating and maintenance service instructions in the literature accompanying this product The lightning flash with arrowhead symbol within an equilateral triangle is intended to alert the user to the presence of uninsulated dangerous voltage within the product s enclosure The dangerous voltage may be of sufficient magnitude to constitute risk of electric shock to persons T...

Page 6: ...an extension cord or power strip is used make sure the cord or strip is rated for the product and the total ampere ratings of all products plugged into the extension cord or strip do not exceed 80 of the cord s or strip s rating limit Route power cords so they are not walked on tripped on or pinched by items placed upon or against them Pay attention to the plug electrical outlet and the point wher...

Page 7: ...ency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee interference does not occur in an installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the in...

Page 8: ... mL ampules 3MA029 Osmolality Linearity Set 5 levels 3LA028 Protinol Protein Based Controls 3 levels 3MA028 Renol Urine Osmolality Controls 2 levels 3LA085 Evaporation cover 112081 Turntable 112077 Replacement sample probe 112140R User s guide USB drive 112005UG Service manual 112008SM NOTE Advanced Instruments cannot guarantee the stated instrument performance specifications and accuracy of test ...

Page 9: ...9 200 mOsm kg Calibration Standard Standard deviation 3 mOsm kg H2O 197 203 194 206 191 209 400 mOsm kg Calibration Standard Standard deviation 3 mOsm kg H2O 397 403 394 406 391 409 500 mOsm kg Calibration Standard Coefficient of variation 0 75 496 504 492 508 488 512 850 mOsm kg Calibration Standard Coefficient of variation 0 75 843 857 836 864 829 871 900 mOsm kg Calibration Standard Coefficient...

Page 10: ...ment IN THE CASE OF EMERGENCY Power to the instrument can be removed by pulling the detachable power cord from the electrical outlet 1 2 Unpack the instrument To unpack the instrument take the following steps Carefully unpack the instrument accessories and supplies and inspect them for shipping damage Use the enclosed packing list Table 1 1 to verify all items were received Save the shipping boxes...

Page 11: ...n 1 OsmoPRO OsmoPRO 1 112077 Turntable 1 112081 Evaporation cover 1 112169 Barcode ID tag kit 1 240820 20 µL sampler 1 Power cord as specified 1 112005UG User s guide USB drive 1 135007PM Warranty card Table 1 1 The OsmoPRO Multi Sample Micro Osmometer Packing List and Accessories ...

Page 12: ... screws from rear access panel Figure1 1 Rear Panel 1 4 Remove the shipping stops CAUTION Do not apply electrical power before removing the cooling assembly and sample probe shipping stops Damage to the motors can result The OsmoPRO is shipped with two shipping stops One secures the sample cooling assembly and the other secures the sample probe Remove warning labels attached to the shipping stops ...

Page 13: ...rew Loosen the thumb screw two full turns Lift the top section of the shipping stop upwards approximately 13 mm and then remove from the instrument Figure 1 3 Reinstall the instrument s rear panel Figure 1 3 Sample Probe Shipping Stop NOTE Any reshipment of the OsmoPRO requires reinstallation of the cooling assembly shipping stop and the sample probe shipping stop ...

Page 14: ...SB Port Figure 1 4 OsmoPRO Front View 1 5 Load printer paper Install as follows Lift open the printer door at top of instrument Figure 1 5 Unroll 4 6 15 20 cm of thermal paper from the roll Hold the roll so paper feeds upwards from the bottom of the roll towards the front of the instrument and place the roll into the printer ...

Page 15: ...utton Figure 1 6 Close Printer Door 1 6 Install turntable If the turntable is not presently installed on the instrument place it on a flat surface with the numbered side visible Place a new probe wiper ring over the center knob of the turntable Align the wiper ring so the wiper ring locating tab is in one of the depressions provided at turntable position 1 and position 11 Verify all the turntable ...

Page 16: ...er the center knob of the turntable with the squared shaped open slot centered at turntable position 1 Figure 1 8 and facing the instrument Grasp the turntable by the center knob and place it on the turntable spindle so the flat side of the evaporation cover fits into the opening in the instrument cover Center knob and turntable Locking Screw Evaporation Cover Figure 1 8 Evaporation Cover ...

Page 17: ...ot to strike the probe assembly Figure 1 9 Turntable Drive Spindle While holding the outer edge of the turntable and evaporation cover with one hand turn the knurled turntable locking screw Figure 1 10 fully clockwise to lock the turntable onto the drive spindle Make sure it is secure but do not over tighten Figure 1 10 Turntable Installed Turntable Drive Spindle Turntable Locking Screw ...

Page 18: ...ushing the rocker style power switch on the instrument s back panel to the I position The instrument initially displays the OsmoPRO Splash screen Figure 1 12 The turntable moves to the home position and the message LOADING PROCESSES appears in the lower right corner of the screen Figure 1 12 OsmoPRO Splash Screen Power Switch Printer Exhaust Fans Serial Number Power Input Module USB A Ports Rear A...

Page 19: ...rent status of the turntable Information regarding the tube position number Sample ID date and time result and test progress appears as the turntable is loaded and tests complete The right side of the Main screen displays the test results The top right corner displays instrument status The Main screen also provides access to information using the two symbols in the lower left corner of the screen ...

Page 20: ...and sports medicine Medical research Biotechnology and pharmaceutical research and manufacturing Food and beverage manufacturing Environmental research and monitoring Academic research Industrial applications For clinical applications the OsmoPRO provides osmolality measurement of biological fluids and is intended for use by trained healthcare professionals to assist in the diagnosis and treatment...

Page 21: ...Osmolality is a common unit of concentration measurement that relates all the colligative properties to each other and to other concentration units Because of its universality most osmometry applications regularly use osmolality expressed as mOsm kg H2O as the common unit of concentration rather than applying further conversion factors 2 2 1 Instrumentation Advanced Instruments Osmometers measure ...

Page 22: ... of solvent not the mass of the particles Colligative properties include vapor pressure boiling point freezing point and osmotic pressure see also Concentrative Properties Concentration The relative amount of solute in a solution This can be expressed in many ways solute to solvent solute to solution mass to mass mass to volume etc Concentrative properties When a solute is dissolved in solvent cer...

Page 23: ...d examples are glucose and urea Osmol Osmole The standard unit of osmolality based on a one molal concentration of an ion in a solution Osmolarity The number of osmoles of solute per liter of solution temperature dependent Osmolality The number of osmoles of solute per kilogram of solvent temperature independent Osmolality equation Osmolality is the number of osmoles of solute particles per kilogr...

Page 24: ...The major liquid component of a solution and the substance into which a solute is dissolved Solutes The minor components of a solution which is dissolved into the solvent Vapor pressure osmometers Instruments which measure the concentration of osmotically active particles which reduce the vapor pressure of the solution ...

Page 25: ...splay its test result During testing test results will appear in the center The right side of the screen shows the instrument status test results and menus Several icons appear on the Main screen others will appear on other screens The icons are defined in Table 3 1 To view filter send print calculate statistics chart and export the results turn to Chapter 6 Icon Description Icon Description Icon ...

Page 26: ...one of the four tabs to display additional information regarding the instrument The tabs are Advanced Instruments Contains contact information for the manufacturer Figure 3 3 Local Distributor Displays the contact information for the local distributor Figure 3 4 Revisions Contains information for software revision firmware revision scanner firmware revision printer firmware revision MAC address IP...

Page 27: ...OsmoPRO Multi Sample Micro Osmometer User s Guide 27 Figure 3 4 Local Distributor Tab Figure 3 5 Revisions Tab Figure 3 6 System History Tab ...

Page 28: ...navigation Pressing MENU located in the bottom right displays a list of various functions From here the user can select an option and navigate away from the Main screen The options available are RESULTS CALIBRATION DIAGNOSTICS and SETTINGS Figure 3 7 Figure 3 7 Main Menu ...

Page 29: ...materials in regulated waste containers and dispose of these materials in a safe and acceptable manner in compliance with all country state and local requirements WARNING It is important the user always pays close attention to the status of the instrument located in the top right hand corner of the display If the status shows TESTING it is not safe to remove the turntable Do not place hands on or ...

Page 30: ...EQUIRED Select a User ID Figure 4 1 and then press ENTER Enter the password using the keyboard Figure 4 2 then press ENTER Figure 4 1 Select User Figure 4 2 Enter Password The turntable will either Complete a full rotation and stop with position one at the load position if the turntable is empty Figure 4 3 or Move the next available tube position to the load position Figure 4 3 ...

Page 31: ...Figure 4 4 Enter Sample ID Load the sample tube in the load position Press NEXT to advance to the next tube position and continue loading sample tubes or press START to begin testing Figure 4 5 NOTE If the user stops loading tubes for over two minutes the instrument prompts the user to continue loading If the user does not respond within 30 seconds the instrument cancels all loading and marks the ...

Page 32: ...4 2 then press ENTER The turntable will rotate and the instrument detects all present tubes Tube positions with tubes will appear gray on the display IF SAMPLE ID IS REQUIRED Enter Sample ID for each loaded position using the keyboard Figure 4 4 Enter the Sample ID manually or scan the barcode then press ENTER Press START and begin testing Figure 4 5 4 3 Cancelling loading samples Press CANCEL to ...

Page 33: ...he test results are also printed After a tube is tested the color of the corresponding tube changes in the turntable tube display Refer to the Main screen legend in Chapter 3 for additional information The user can end the test at any point by pressing CANCEL While a sample test is in progress the user can load more samples onto the turntable by pressing LOAD MORE 4 5 Load more NOTE The load more ...

Page 34: ...ibrate and the instrument reverts to the last successful calibration values Recalibrate the instrument if the ambient temperature changes more than 5 C from the last calibration Calibration testing can only be performed within the calibration procedure Testing of reference materials controls or any unknown samples must be performed using the test procedure described earlier NOTE Calibrate the Osmo...

Page 35: ...bration testing begins The Calibration in Progress screen displays Figure 4 9 the calibration test progress and the results Successfully tested individual calibration standards are indicated by the text DONE and are displayed both on screen and on the printout Successfully tested calibrator groups are indicated by the text XXXX CAL DONE where XXXX is the calibration standard value This appears on ...

Page 36: ...e 4 11 Calibration Successful Screen If the calibration failed the reason for the failure is displayed For example if calibration failed and the message states Wrong Calibrator 1 Figure 4 12 this indicates the calibration test was set up incorrectly If a failure occurs during the calibration test process the system will display the error and automatically terminate the test run Follow the instruct...

Page 37: ...rmulated to simulate biological solutions Several biological controls are commercially available and may be recommended or specified in your area Contact your Advanced Instruments representative to obtain Protinol Protein Based Controls or Renol Urine Osmolality Controls Check with your professional associations and regulatory bodies for their guidelines rules and regulations and refer to the reco...

Page 38: ...imize the time a pipetted sample is waiting to be tested Use only the Advanced Instruments sample tubes Never re run a previously tested sample tube Dispense a new aliquot of the sample to be rerun into a new sample tube Never reuse probe wiper rings They are designed to be single use only Keep the sample cooling chamber clean with cleaning swab periodically every 10 20 test series or two weeks Ne...

Page 39: ...reen The icons located along the top of the screen allow the user to navigate through the results Using these icons the user can perform more functions within the Results screen See Table 6 2 for explanation of the Results screen symbols Icon Description Icon Description Icon Description Search filter Clear search filter Clear selection Top page Page up Scroll left Bottom page Page down Scroll rig...

Page 40: ...his function to print records from the results database In the Results screen press the rows containing the desired results highlighting them blue Select the desired records by pressing them which highlights them in blue Multiple rows may be selected at a time Once the user selects the desired results press PRINT The printout shows the following result information Date Result Sample ID if enabled ...

Page 41: ...gure 6 4 Statistics 6 5 Chart Use this feature to display a Levey Jennings chart for a selected control Figure 6 5 The chart function is only available for results with a Sample ID and when the Sample ID is entered as a control See Controls section for more info Press CHART to open a Levey Jennings chart for that particular lot of control material An example of a Levey Jennings chart for a 2000 mO...

Page 42: ...XPORT A window Figure 6 6 confirms successful data export If the user wishes to export specific result records the user must filter the database as discussed in section 6 1 After using the desired filter to display specific result records press EXPORT and the filtered selection will be exported The csv file name contains the date and time of export Figure 6 6 Results Database Exported ...

Page 43: ...il below The key icons located on each button indicate User ID and password are required to enter these functions The color of the key indicates the required access level Figure 7 2 To exit the Settings screen and return to the Main screen press HOME NOTE The OsmoPRO contains a default supervisor account Use this account to login to the various settings screens listed in this section USER ID Admin...

Page 44: ...XIT to return to the Settings screen 7 1 1 Date To change the date select the desired field then use the arrow icons to make the changes 7 1 2 Time To change the time select the desired field then use the arrow icons to make the changes 7 1 3 Regional format settings To modify the regional format settings un check the Use Regional Format Settings option The user can change the instruments date for...

Page 45: ...restart to apply the change Power the instrument off using the power switch on the rear of the instrument Wait 10 seconds and power on the instrument Upon power up the instrument displays and prints the newly selected language Figure 7 4 LANGUAGE 7 3 Users To modify the user account information press USERS Select a user and enter a password The Users screen opens Figure 7 5 Here the supervisor can...

Page 46: ...rator and supervisor The privileges of these two levels differs 7 3 3 Supervisor A supervisor can login to any screen A Gold Key indicates only a supervisor is granted access The supervisor can change the privileges given to the operators this is done in the Restrictions screen See Restrictions section A supervisor can also access the Service screen to perform software and firmware updates and to ...

Page 47: ...SAVE and then EXIT to return to Users screen Figure 7 8 Edit User 7 4 H W options To change hardware H W related options press H W OPTIONS The user is prompted to select a user Enter the password The H W Options screen opens Figure 7 9 Along the top of this screen there are four different tabs allowing the user to change various H W related options The tabs consist of Audio LCD Printer and Barcode...

Page 48: ...nd or volume press the corresponding radio button to play the sound Press TEST ERROR SOUND to play the error sound Press SAVE to save settings changes Press EXIT to return to the Settings screen Figure 7 9 Hardware Options Audio 7 4 2 LCD This tab is where the user can adjust the LCD brightness level Figure 7 10 Use the slider bar to set the desired brightness level The user can preview various br...

Page 49: ...ted to the results and events databases and LIS if enabled To enable or disable the printer select the desired option then press SAVE Press EXIT to return to the Settings screen Figure 7 11 Printer 7 4 4 Barcode This tab is where the user can adjust the brightness level of the barcode scanner LED Figure 7 12 The level can be changed to Low Medium or High To change the brightness select the desired...

Page 50: ...urned off this allows the Turntable to be rotated freely by hand to center the sample probe as it is being lowered into the wipe position The sample probe must be lowered until it enters the wipe position use the Select number of steps to adjust how far the sample probe moves Press the arrows to move the sample probe up or down NOTE DO NOT LOWER THE SAMPLE PROBE MORE THAN NECESSARY When the turnta...

Page 51: ... select Learn at this time NOTE THE FIXTURE SHOULD BE ABLE TO BE REMOVED WITH A MINIMAL AMOUNT OF FORCE Press MOTOR SELECT to change from BLOCK MTR to SAMPLE MTR Remove the sample tube Height Positioning Fixture and carefully lower the sample probe until there is a minimal amount of interference between the sample tube and the sample probe This can be determined by trying to lift the sample tube o...

Page 52: ...robe or cooling assembly were replaced The correct resistance values and information were set at the factory If these values are changed to incorrect values the performance of the instrument is directly affected After making a change to one or both resistance values the instrument requires calibration and does not allow the user to run a sample test until a successful calibration occurs NOTE CHANG...

Page 53: ... keyboard icon The Keyboard screen opens Figure 7 17 Here the user can enter the new Lot Number Press ENTER Figure 7 17 Sample Probe Lot Number 7 7 Controls To view control information press CONTROLS The user is prompted to select a user Enter the password The Controls screen opens Figure 7 18 Here the user can add delete edit chart and set action Figure 7 18 Controls ...

Page 54: ...tered manually Press SAVE to save the newly created control Press EXIT to return to the Controls screen Figure 7 19 Add Edit Control 7 7 2 Deleting an existing control To delete a control select the desired control then press DELETE A message displays Do you want to delete 3MA085 for example Figure 7 20 Press YES to delete the selected control Figure 7 20 Delete Control 7 7 3 Editing an existing c...

Page 55: ...the box labeled SD Bands in the lower left corner to filter the data based on the selection Press EXIT to return to the Controls screen Figure 7 21 Levey Jennings Chart 7 7 5 Setting control actions This function is only available on the Controls screen when the user is logged in with a supervisor access level To change the action settings for the controls press ACTION Figure 7 22 The supervisor c...

Page 56: ...23 This screen is where the user can establish the LIS connection and modify the various LIS settings Once the desired settings are changed press SAVE Press EXIT to return to the Settings screen Figure 7 23 LIS LAN 7 8 1 LIS enabled To enable LIS on the instrument check the box next to the text LIS Enabled A check mark indicates the setting is enabled To disable LIS uncheck the box Once the user c...

Page 57: ...ypad Press ENTER once completed 7 8 4 Changing server IP address To change the server IP address press the keyboard icon The numeric Keyboard screen opens Enter the server IP address using the numeric keypad Press ENTER once completed 7 8 5 Ping Use this function to test the network connection With LIS enabled enter a valid server IP address then press PING If the connection is successful the circ...

Page 58: ...o select a user then enter the password The Service screen opens Figure 7 25 Here the supervisor can perform a system update and manage system databases Figure 7 25 Service System Update 7 9 1 System update The System Update screen will display the current revisions of software and firmware To perform an update the Service System Update tab must be selected Figure 7 25 There are two types of syste...

Page 59: ...evisions to confirm the revision shown 7 9 2 Databases To clear or export the various databases select the Databases tab Figure 7 26 Here the user can select which database to export or clear To export a table select the desired table Results Events Users or Controls Insert a USB memory drive and press EXPORT CSV to export the database To delete a table select the desired table Press CLEAR The Raw...

Page 60: ...Restrictions 7 10 1 Required for test This is where the user can change settings regarding testing To make a change press on the desired option a checkmark indicates the option is enabled User ID required indicates a User ID and password must be entered before a sample test is started Sample ID required indicates each sample loaded requires a Sample ID to be entered 7 10 2 Allow operators to Use t...

Page 61: ...From the Diagnostics screen press A D to open the A D screen Figure 8 2 Using this screen the user can perform A D samples Press EXIT to return to the Diagnostics screen A D tests are designed to check the performance of the analog to digital converter A D sample probe block probe cooling assembly and the efficiency of heat transfer between the components of the cooling assembly Results are presen...

Page 62: ...this range it may point to issues with the A D Refer to the troubleshooting section or contact Advanced Instruments Hot Line Technical Service 8 2 Motors From the Diagnostics screen press MOTORS to enter the Motor Test screen Figure 8 3 This screen allows the user to test the functionality of the systems 3 motors Each motor can be moved individually by the user Figure 8 3 Motor Test Screen The tur...

Page 63: ...turntable motor can now rotate to the correct turntable position based on the user s selection Turntable State Description LOAD Press LOAD to move the turntable to the load position of the selected tube position The load position is when the selected position is facing the user The selected position should be aligned with the opening in the front of the evaporation cover TEST Press TEST to move th...

Page 64: ...a sample probe test Select the position to load with a sample tube from the window using the arrows NOTE On screen entry the system displays the next available tube position Press LOAD Turntable rotates to the selected tube position making it available for loading Load the sample onto the turntable Press TEST Test Status is updated with test progress or error message if any The result is reported ...

Page 65: ...o displays See the list for the types of barcodes recognized by the scanner Aztec GS1 Codabar INTERLEAVED 2 of 5 ITF Code 39 PDF417 Code 128 QR Data Matrix ECC UPC EAN Table 8 2 Barcodes Recognized 8 5 Events To view the Events database press EVENTS from the Diagnostics screen Figure 8 6 The Events screen is a database of system events System events consist of these general topics Power Up Calibra...

Page 66: ...er Top page Page up Left arrow Bottom page Page down Right arrow Table 8 3 Events Database Key 8 5 1 Filter On the Events screen press the search filter Icon to display the Filter screen Figure 8 7 Figure 8 7 Events Filter Event records can be filtered by Event Type Description Date Range and User ID To filter event records Enter the desired search details and press SEARCH The Events screen displa...

Page 67: ...xport Figure 8 8 Figure 8 8 Events Database Exported 8 6 Printer From the Diagnostics screen press PRINTER to open the Printer Test screen Figure 8 9 Here the user can test the functionality of the printer The status of the printer is shown here Figure 8 9 Printer Press TEST to send text to the printer If printer is functioning correctly status shows READY Press EXIT to return to the Diagnostics s...

Page 68: ...klight adjusts This screen is not where the brightness level can be set refer to section H W Options 8 7 2 Pixel test Use this to test for issues regarding Dead pixels on the LCD display Dead pixels are defective pixels which display on the LCD as Black To start the test press PIXEL TEST This opens a solid color screen Press on the screen to advance to the next test pattern The various test patter...

Page 69: ...urn to the Diagnostics screen 8 9 Cleaning From the Diagnostics screen press CLEANING to enter the Probe Cleaning screen Figure 8 12 This screen is where the user can lower the sample probe for cleaning purposes Figure 8 12 Cleaning The user must remove the turntable then press LOWER PROBE to lower the sample probe Once the probe lowers the user now has easy access to clean the probe After cleanin...

Page 70: ...ntable from the instrument and the cooling well is now visible Insert the flexible swab into the round opening in the cooling well 9 1 3 Monthly maintenance Exhaust Fans Examine the exhaust fans on the rear of the instrument to ensure they are unobstructed by dust or debris If cleaning is needed power the instrument off and use compressed air to remove the debris obstructing the fans 9 1 4 Semiann...

Page 71: ...9 1 Error Screen 9 2 2 Fatal errors Errors can occur during testing which will stop the entire test process these are called fatal errors The test is stopped for the safety of the instrument An on screen message will indicate the error Figure 9 2 If a fatal error occurs it will restrict the user from starting another test until the issue is resolved If a fatal error occurs call Advanced Instrument...

Page 72: ...se errors occurs depending on the action set These errors will also be recorded on the printout and stored in the Events Database If sample test related errors occur the user cannot troubleshoot resolve call Advanced Instruments Hot Line Technical Service Possible Sample Test Errors Sample Did Not Freeze Sample Pre Freeze Test Time Out No Tube Detected Out of Range Low High NOTE If one of these er...

Page 73: ...inter paper then clear error Printer Door Open Close the printer door and clear error Calibration Required Instrument settings changed such as probe resistances or motor alignment instrument needs new calibration Perform a successful calibration test then clear error Turntable proximity sensor too much ambient light Tube proximity sensor too much ambient light Move the instrument away from excessi...

Page 74: ... see if the issue persists Sample may be above range of instrument Sample cooling well may need cleaning Sample probe may need cleaning Sample Tube Not Detected The sample tube not present on turntable If sample tube was present yet not detected try another load position Test Time Out Confirm good technique and pipette condition Re pipette the sample or re run using a known control such as Clinitr...

Page 75: ...essage indicates the wrong calibration standard is in the wrong position Positions 1 3 should consist of 2000 mOsm Positions 4 6 should consist of 850 mOsm Positions 7 9 should consist of 50 mOsm Follow the on screen instructions to set up calibration Retry calibration Calibrator 1 out of range Calibrator 2 out of range Calibrator 3 out of range Too much variation in the calibration standards Conf...

Page 76: ...kup Integral lithium cell 10 year life typical not user replaceable Classifications Protection class I Over voltage category II Pollution degree 2 Moisture protection IPX0 ordinary Communications USB 2 0 Type A ports 3 USB 2 0 Type B ports 1 Ethernet port 1 Operating conditions Temperature 18 C to 35 C 64 F to 95 F Humidity 30 to 80 relative humidity non condensing Storage temperature 40 C to 45 C...

Page 77: ...p clsi org Reportable range 0 2000 mOsm kg H2O Resolution 1 mOsm kg H2O Accuracy salt solutions 1 0 400 mOsm kg H2O Mean value 3 mOsm kg H2O from nominal value 400 2000 mOsm kg H2O Mean value 0 75 from nominal value Repeatability within run 1 0 400 mOsm kg H2O Standard deviation 3 mOsm kg H2O 400 2000 mOsm kg H2O Coefficient of Variation 0 75 Temperature Effects2 Less than 1 mOsm kg H2O for every ...

Page 78: ...n urine by filtration Samples with air bubbles do not reliably freeze and may yield inaccurate results Samples allowed to evaporate will yield higher osmolality values Non aqueous solutions will not yield accurate results The OsmoPRO is intended to test aqueous solutions only Highly viscous solutions may not reliably freeze and may yield inaccurate results High concentrations of ethanol acetone me...

Page 79: ... Electrical Equipment for Laboratory Use Part 1 General Requirements The US in the lower right of the ETL mark demonstrates this listing Canadian Safety This product was listed by ETL testing laboratories as being in compliance with the requirements of CAN CSA C22 2 No 61010 1 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use General Requirements The C in the ...

Page 80: ...and this device must accept any interference received including interference which may cause undesired operation Canadian This Class B digital apparatus complies with Canadian ICES 003 ICES 003 Cet appareil numérique de la classe B est conforme à la norme NMB 003 du Canada Japan VCCI This Class B digital apparatus complies with VCCI technical requirement V 3 EC Declaration of Conformity WEEE This ...

Page 81: ...ol 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 Canada In Vitro Diagnostic Medical Device complying with EU Directive 98 79 EC ...

Page 82: ...T THEREOF CAUSED BY IMPROPER INSTALLATION UNAUTHORIZED REPAIR OR ALTERATION NEGLIGENCE ABUSE OR MISUSE INCLUDING USE OF IMPROPER GLASSWARE OR REAGENTS ACCIDENT OR ACT OF GOD Attention is called to the user s responsibility regarding reasonable use useful life of the instrument and immediate notification of accident outlined in the warranty duties section of the user s guide and or service manual N...

Page 83: ...iates the instrument but not to exceed 10 years from date of delivery to the user Only during the time the equipment was maintained on a regular basis as prescribed by Advanced Instruments If the user is in an area which has no local service Advanced Instruments may require a local service person understood to mean the person performing the hands on service of the equipment to attend and pass a re...

Page 84: ...fication to Advanced Instruments immediately the same day if possible in the event of injury to any person in circumstances involving Advanced Instruments equipment in which Advanced Instruments might be named as a defendant in any form of litigation Allowing Advanced Instruments or its representatives immediate full and thorough examination of Advanced Instruments equipment and all records pertai...

Page 85: ...formation from the LIS as needed The LIS may initiate sending patient work order information to the OsmoPRO in advance of sample runs The information is parsed and stored in the system for later use Setting up OsmoPRO LIS communications To configure the OsmoPRO for LIS communications the OsmoPRO computer s LAN connection must be configured and its LIS connection set up Configuring the LAN connecti...

Page 86: ...r Code Stop Attention Record Review Caution Hot Surface Setup Dangerous Voltage Calibration Lifting Hazard Cancel Delete Calibrator Content Do Not Open Top Control Handle with Care Negative Control Toxic Use Blade to Open Positive Control Flammable Do Not Re Use Fragile For In Vitro Diagnostic Use Irritant European Conformity Keep Dry Temperature Limit Date Manufactured See Instructions Sterile Lo...

Page 87: ...t Low Fluid Level See Instructions for Temperature Guidelines Keep Hands Clear Potential Puncture Hazard Manufacturer Electronic Equipment Dispose of Properly Biohazard Laser Hazard Cut Hazard Static Discharge Sensitive to static electricity Table G 1 Symbol definitions ...

Page 88: ...ing guidelines are provided to assist in identifying the options available once deciding to replace or dispose of this product Contact the supplier who sold you the product Whether this is Advanced Instruments itself or 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 cases...

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