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Advanced Instruments Osmo1 User Manual Download Page 30

30

Osmo1

®

Single-Sample Micro-Osmometer User Guide

Chapter 4

Calibration

IMPORTANT:

Calibrate the Osmo1

only

with Advanced

Instruments Calibration Standards.

Using calibration standards that are not manufactured
by Advanced Instruments may yield inaccurate results
and is not recommended.

4.1 Factory calibration

Your Osmo1 unit was factory-calibrated with 50, 850,
and 2000 mOsm/kg H

2

O calibration standards before it

shipped. The factory calibration is stored within its
memory. Therefore, you do not need to calibrate the
instrument upon installation.

4.2 When to recalibrate

Advanced Instruments recommends that you recalibrate
the Osmo1 in any of the following cases:

•

If the test results for the reference solutions are out of
specification

NOTE:

Advanced Instruments recommends that you
test appropriate reference solutions daily to
verify the calibration. For more information, see
“Daily procedure” on page 24.

•

If the instrument has been serviced (especially if any
instrument hardware was replaced)

•

If the ambient temperature has changed more than
5 °C since the last calibration

•

In any other circumstances where calibration is
recommended or required based on the regulations
that govern your laboratory

4.3 Calibration procedure

The Osmo1 has a built-in calibration function that guides
you through testing five samples each of either two or
three known standards:

•

2-point calibration uses the 50 and 850 mOsm/kg H

2

O

calibration standards.

•

3-point calibration uses the 50, 850, and 2000
mOsm/kg H

2

O calibration standards.

By default, the system is configured to perform a 3-point
calibration.

NOTE:

Supervisors can change the number of calibration
points on the Calibration tab of the Restrictions
screen. For instructions, see “Assigning
restrictions” on page 46.

To perform a calibration:

1.

From the Home screen, tap the menu icon
(Figure 22).

Figure 22: Menu icon

The Main menu displays (Figure 23).

Figure 23: Osmo1 Main menu

2.

From the Main menu, tap

Calibration

.

The system prompts you to log in.

3.

Select yourself from the list of available users.

NOTE:

Supervisors can choose to allow all operators
to perform calibrations, or they can restrict
access to supervisor-level only. For more
information, see “Assigning restrictions” on
page 46.

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Summary of Contents for Osmo1

Page 1: ...Osmo1 Single Sample Micro Osmometer User Guide 133005ENSI Rev 5 ...

Page 2: ...truments The following are trademarks of Advanced Instruments Osmo1 Hot Line Protinol Clinitrol Renol 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 Screenshots and imag...

Page 3: ...ocedure 26 3 6 Repeatability tips 29 Chapter 4 Calibration 30 4 1 Factory calibration 30 4 2 When to recalibrate 30 4 3 Calibration procedure 30 4 4 Canceling calibration 32 Canceling the test in progress 32 Canceling the entire calibration 32 4 5 Calibration errors 32 Chapter 5 Results 33 5 1 Viewing the results list 33 5 2 Sorting the results list 33 5 3 Filtering the results list 33 5 4 Exporti...

Page 4: ...18 Clearing Osmo1 data 49 Chapter 7 Diagnostics 50 7 1 Accessing the Diagnostics menu 50 7 2 A D 50 7 3 Consumables 51 7 4 Sample probe 52 7 5 Barcode 52 7 6 Events 52 7 7 Printer 53 7 8 LCD 53 7 9 Solenoid 53 Chapter 8 Maintenance troubleshooting 54 8 1 Who should perform service 54 8 2 Issues that require a service technician 54 8 3 ESD precautions 54 8 4 Maintenance 55 Chamber cleaning 55 Solen...

Page 5: ...r Service department US or Canada Toll free phone 800 225 4034 from 8 00 AM 4 30 PM Eastern time Fax 781 320 3669 Outside the US or Canada Phone 1 781 320 9000 Fax 1 781 320 3669 Email orders aicompanies com Hot Line Technical Service For any questions or problems related to operation or service contact the Hot Line Technical Service department US or Canada Toll free phone 800 225 4034 from 8 00 A...

Page 6: ...e Osmolality Controls 2 levels 3LA085 Other standards Item Part Number 100 mOsm kg Calibration Standard ten 5 mL ampules 3LA011 200 mOsm kg Calibration Standard ten 2 mL ampules 3MA020 400 mOsm kg Calibration Standard ten 2 mL ampules 3MA040 500 mOsm kg Calibration Standard ten 5 mL ampules 3LA051 900 mOsm kg Calibration Standard ten 5 mL ampules 3LA091 1000 mOsm kg Calibration Standard ten 2 mL a...

Page 7: ...ou check with your professional associations and regulatory bodies for their guidelines rules and regulations Verifying calibration daily Verify the accuracy of the Osmo1 daily using Advanced Instruments reference solutions and controls Compare the test results produced by the instrument to expected values Recalibrate the instrument if the test results are outside of the expected ranges After reca...

Page 8: ...02 96 104 94 106 200 mOsm kg Calibration Standard Standard deviation 2 mOsm kg H2O 198 202 196 204 194 206 400 mOsm kg Calibration Standard Standard deviation 2 mOsm kg H2O 398 402 396 404 394 406 500 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 Standar...

Page 9: ...roduct must have an IEC 60320 connector Plug the product into an approved grounded electrical outlet Exposure to AC voltage could lead to electric shock burn or electrocution Please be aware of any exposure of AC voltage in the power cord Do not disable the power cord grounding pin If an extension cord or power strip is used make sure that the cord or strip is rated for the product and that the to...

Page 10: ...ersons This symbol alerts the user to the presence of internal components that could be damaged by static electricity This symbol alerts users to the presence of biological substances that may pose a threat to the health of living organisms primarily that of humans This symbol indicates potential puncture hazards users keep hands clear This symbol alerts the user to the presence of a specific comp...

Page 11: ... interference at his own expense Industry Canada Statement CAUTION Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment ATTENTION Tout changement ou modification non expressément approuvé par la partie responsable de la conformité pourrait annuler l autorisation de l utilisateur d utiliser l équipement ...

Page 12: ...ve properties measurement of the freezing point easily permits the precise determination of the concentration of an aqueous solution The freezing point of pure H2O is precisely 0 010 C One mole of a non dissociating solute a substance which does not dissociate into ionic species such as glucose dissolved in 1 kilogram kg of water depresses the freezing point of the water by 1 858 C This change is ...

Page 13: ...y heat of fusion causes the sample temperature to rise toward a plateau temperature where a liquid solid equilibrium occurs The equilibrium temperature is the freezing point of the solution The duration of the liquid solid equilibrium phase is a function of the speed at which the heat of fusion is liberated versus the speed at which it is dissipated to the surrounding environment This ratio can be...

Page 14: ...e changed nearly in proportion to the concentration of the solute expressed in dissolved particles Avogadro s number of particles regardless of their size or shape when dissolved in a kilogram of water will change each of the concentrative properties a specific amount Freezing point osmometers Instruments which measure the osmotic strength of solution by using freezing point depression Freezing po...

Page 15: ...iosmole mOsm is 10 3 osmoles The osmolality equation is Osmolality ϕnC osmole kg H O where ϕ osmotic coefficient which accounts for the degree of molecular dissociation n number of particles into which a molecule can dissociate C molal concentration of the solution Osmolarity The number of osmoles of solute per liter of solution temperature dependent Osmotic pressure The hydrostatic pressure produ...

Page 16: ...trument is not grounded properly its operation may be impaired and a safety hazard may exist Verify that the outlet is appropriate before operating your instrument Do not disable the grounding plug 1 2 Unpacking the shipment Table 1 lists the items contained in your shipment Qty Part Description 1 Osmo1 Osmo1 Single Sample Micro Osmometer 1 3M0825 20 µL Ease Eject Sampler 1 Power cord 1 133005UG U...

Page 17: ...port of Concealed Damage and then file your claim Contact Advanced Instruments immediately for repair or replacement of the items 4 Complete the online warranty card to register your product Figure 1 identifies the major components of your osmometer including Sampler Sampler holder a convenient resting place for the sampler when it is not in use Operating cradle Cooling chamber inside Touchscreen ...

Page 18: ...left of the instrument before testing can begin As shown in Figure 4 the box must be oriented so that The photo of the instrument and the box label are toward the back The dispensing flaps for the chamber cleaners and sampling tips are toward the front If a Micro Sample Test Kit is not in place on the instrument when you attempt to run a test you will receive the error AI consumable box not detect...

Page 19: ...ings menu NOTE For instructions see Accessing the Settings menu on page 35 2 If the unit s language is not set appropriately for your site change the language settings NOTE For instructions see Setting language on page 37 NOTE For a language change to take effect you must power off the Osmo1 wait 10 seconds and then power on the instrument 3 If the date or time displayed on the unit is incorrect s...

Page 20: ...1 to connect to your local area network LAN NOTE For instructions see Configuring a LAN connection on page 45 8 If desired set up control limits NOTE For instructions see Establishing controls on page 41 9 When you have finished configuring the instrument tap the Home button on the Settings menu to return to the Home screen Setup for the Osmo1 is now complete If you want to begin testing with the ...

Page 21: ...d gentle finger pressure CAUTION Never use sharp objects fingernails pens pencils or anything that would leave a mark on the screen or damage it 2 2 Common screen elements Table 2 lists elements that appear on many screens Item Description Use Status indicator Green Normal operation Red System error condition Yellow Test in progress Orange IDs required Current date and time Sampler tip status Whit...

Page 22: ...e the barcode scanner then use the keyboard or barcode scanner to enter the sample ID NOTE The color of the button indicates the Sample ID status Blue Sample ID is optional Orange Sample ID is required See Requiring IDs for testing on page 48 Example of a warning message Tap to display the Main menu Table 3 Items on the Home screen Enter sample ID Display Main menu Progress bar Warning message Lat...

Page 23: ...t information for assistance instrument revisions and serial number Error messages LIS enabled and functioning LIS not enabled LIS enabled connected and not functioning Keyboard input Select date USB thumb drive Clear selection Define filter Clear filter Top of list End of list Page up Page down Move page left Move page right Operator and supervisor access Supervisor only access Go to Main menu Go...

Page 24: ...n explosive atmosphere Use caution and appropriate personal protective equipment PPE if you must put your hands inside the osmometer Placing hands into the opening could result in skin punctures or other injuries 3 1 Daily procedure Your Osmo1 unit was factory calibrated so you can begin using it as soon as you have unpacked it and completed the installation and setup steps described in Chapter 1 ...

Page 25: ... Best practices For best results adhere to these guidelines when testing Avoid testing in drafty areas Verify that the sample is thoroughly mixed Keep sample fluids covered if possible to minimize evaporation or contamination Never re run a previously used sample Do not re use sample tips or cleaners 3 4 Preparing the Osmo1 for testing Before starting a test verify that The Osmo1 is displaying the...

Page 26: ...Login status Gray Login is optional Orange Login is required Green A user is already logged in The username is displayed by the Login button If you need to log in but another user is still logged in you can tap the Login button to log out that user 3 1 From the Home screen tap the Login button The Select User screen displays 3 2 Select the appropriate username from the drop down list and tap Enter...

Page 27: ...Gently release the plunger to load a 20 μL sample Figure 15 Acquire sample 7 Look at the sample you have just drawn If there are voids or bubbles in the sample discard it and load another sample that does not contain voids 8 Remove any sample on the outside of the tip using a clean lint free non ionic paper Quickly swipe the end of the sampler tip to remove any excess sample protruding beyond the ...

Page 28: ...cools the sample After a moment you will hear the solenoid impact several times during the last stages of testing This is normal operation When the test completes the resulting osmolality displays in the middle of the screen The software provides the instruction to remove the sampler and clean the chamber Figure 20 Test results are stored in the Results database NOTE If you want to cancel a test y...

Page 29: ...solutions uniformly before the test Discard ampules after use Do not store open ampules with Parafilm Keep sample containers closed when not in use Micro samples are more susceptible to contamination and evaporation than larger samples Cold samples are susceptible to condensation warmer samples are susceptible to evaporation Only use the sampler that was supplied with your instrument or one that i...

Page 30: ...t temperature has changed more than 5 C since the last calibration In any other circumstances where calibration is recommended or required based on the regulations that govern your laboratory 4 3 Calibration procedure The Osmo1 has a built in calibration function that guides you through testing five samples each of either two or three known standards 2 point calibration uses the 50 and 850 mOsm kg...

Page 31: ...is canceled the system prompts for a retest using a new sample If two failures occur within the same standard group that calibration fails and the screen displays the message Two replicate failures Upon completion of the last calibration test the system displays a Calibration successful message Figure 27 or the reason for failure Figure 25 Calibration screen calibration in progress Figure 26 Two r...

Page 32: ...n 4 5 Calibration errors Table 6 lists errors that can occur during Calibration Error Possible cause Suggested action Calibration failed Action Repeat calibration Calibration required Cause A significant maintenance event has occurred for example the probe resistance has been changed Action Recalibrate the instrument Calibrator out of range 50 mOsm kg 850 mOsm kg or 2000 mOsm kg Cause Too much var...

Page 33: ...scroll the list sideways The number superimposed on the page icon shows the number of records currently selected Figure 31 Navigation buttons 5 2 Sorting the results list You can tap the gray arrow in the Date Time column header to sort entries in either ascending or descending timestamp order 5 3 Filtering the results list To make the results list more manageable you can filter the results to dis...

Page 34: ...he Clear Filter icon the magnifying glass with a red X at the top of the screen Once you have selected the particular row or rows you are interested in tap the button for the action you want to perform NOTE The buttons are located on the bottom of the Results screen Figure 30 Print Prints the selected results Statistics Performs statistics on up to 20 selected results and displays a report Figure ...

Page 35: ...e database management system utilities Restrictions Set operator level access Set password expiration period Enable disable requirement to enter the User ID and Sample ID for testing Table 7 Functions available from the Settings menu To access the Settings menu 1 From the Home screen tap the menu icon Figure 36 Figure 36 Menu icon The Main menu displays Figure 37 Figure 37 Osmo1 Main menu 2 From t...

Page 36: ...of a Settings session While you are logged into a Settings function the system monitors for inactivity After five minutes of inactivity the system displays a message asking if you want to continue If you do not respond to the prompt within 30 seconds your session times out The system logs you out discards unsaved changes and returns to the Home screen 6 4 Default user accounts The system ships wit...

Page 37: ...t and enter the corresponding password NOTE If user accounts are not configured log in under the Admin account see Default user accounts on page 36 The Language screen opens Figure 42 Figure 42 Language screen 3 On the Language screen make the appropriate selection then tap Save 4 Tap Exit to return to the Settings menu NOTE If the system detects unsaved changes it asks if you want to save changes...

Page 38: ... Add to set up a new user The Add New User screen displays Figure 44 Figure 44 Add new user screen 2 Tap the keyboard symbol to the right of the ID entry field to display a keyboard Type the ID username for this user then tap Enter 3 Tap the keyboard symbol to the right of the Password entry field to display a keyboard Type the password for this user then tap Enter 4 Select either Operator or Supe...

Page 39: ...t user accounts on page 36 The Hardware Options screen opens with the Audio tab in front Figure 46 3 Select the tab for the hardware whose settings you want to view or adjust 4 If desired edit the settings on that tab then tap Save to save the changes NOTE Each tab is described in the following sections 5 Repeat step 3 and step 4 for any other hardware options you want to view edit 6 When you have...

Page 40: ...le of the lower vertical section The barcode scanner is enabled by default You can adjust the brightness of the barcode scanner or disable it from the Barcode tab Figure 49 If you change settings tap Save Figure 49 Barcode scanner options screen 6 9 Adjusting probe resistance NOTE Do not change the probe resistance setting unless the sample or block probe is being replaced NOTE If you make any cha...

Page 41: ...to enter an ID for the control and displays a keyboard 2 Enter the ID NOTE You can use the keyboard displayed on the screen or you can use the barcode scanner on the front of the Osmo1 see Figure 1 on page 17 NOTE To use the barcode scanner hold the control with its label positioned a few inches in front of the barcode scanner The scanner reads the barcode and automatically populates the ID and Co...

Page 42: ...spective field Lower and Upper to open a keypad then type the appropriate value and tap Enter 7 When each field on the Add Edit Control screen contains an appropriate value tap Save NOTE All fields must be filled out to add a new control 8 Tap Exit to return to the Controls screen The new control you added now appears in the list Figure 53 Figure 53 New control appears in list Editing a control 1 ...

Page 43: ...is outside the control limits NOTE This action functions only if you use Sample IDs during testing 1 From the Controls screen select a control then tap Action The Action Setup screen displays Figure 57 Figure 57 Control outside boundary Action screen 2 Select Issue Warning then select the range limit for the action either 1 2 or 3 standard deviations 3 Tap Save to save the action setup The system ...

Page 44: ... and enter the corresponding password NOTE If individual user accounts are not configured log in under the Admin account see Default user accounts on page 36 The LIS LAN screen displays with the LIS tab in front Figure 59 Figure 59 LIS tab of the LIS LAN screen 3 On the LIS tab enter the IP address NOTE Tap the keyboard icon to the right of the Server IP Address field to display a numeric keypad F...

Page 45: ...lue then tap Enter to close the keypad and return to the LAN tab 6 Tap Save to save your LAN settings 7 Tap Exit to return to the Settings menu 6 13 Service The Service screen provides access to administrative utilities From here you can perform software updates and export Osmo1 data The Service screen is available only to users with supervisor level access Performing a system update NOTE To perfo...

Page 46: ...ases deletes the data and it cannot be recovered Be sure that you want to do this before tapping Clear For more information see Clearing Osmo1 data on page 49 6 When you are finished tap Exit to return to the Settings menu 6 14 Assigning restrictions A user with supervisor level access can define whether operator level users are allowed to perform the following functions Change language Change LIS...

Page 47: ...able to perform that function NOTE A checkmark indicates that users with operator level access are allowed to perform calibration Select the number of calibration points you want to use either 2 point or 3 point NOTE A 2 point calibration uses 50 and 850 mOsm a 3 point calibration uses 50 850 and 2000 mOsm Tap Save to save your settings on this tab 6 Select the Testing tab to bring it to the front...

Page 48: ...ID and or Sample ID before running a test This setting is located on the Testing tab of the Restrictions screen To view or change the ID requirement refer to Assigning restrictions on page 46 Home screen when IDs are not required By default the system does not require users to enter the User ID or Sample ID before testing When IDs are not required and no one is logged in to the system the login ic...

Page 49: ... it cannot be recovered Be sure that you want to do this before proceeding To clear the databases manually 1 From the Settings menu open the Service screen as described in Exporting Osmo1 data on page 46 2 From the Service screen select the Databases tab to bring it to the front see Figure 63 on page 46 3 In the Table section select the database you want to clear Results Events Users or Controls 4...

Page 50: ...ttons To access the Diagnostics menu 1 From the Home screen tap the menu icon Figure 71 Figure 71 Menu icon The Main menu displays Figure 72 Figure 72 Osmo1 Main menu 2 From the Main menu tap Diagnostics The Diagnostics menu displays Figure 73 Figure 73 Diagnostics menu From the Diagnostics menu you can tap a button to select a function described in the following sections or you can tap the Home b...

Page 51: ...are finished working on this screen tap Exit to return to the Diagnostics menu 7 3 Consumables The Consumables function allows you to check the status of the instrument s consumables Micro Sample Test Kit NOTE The Micro Sample Test Kit must be positioned correctly on the Osmo1 for this diagnostic to function properly See Placing the Micro Sample Test Kit on the instrument on page 18 From the Diagn...

Page 52: ...rcode scanner If successful you will hear a beep and the barcode information displays on screen Tap Exit to return to the Diagnostics menu Figure 77 Barcode screen 7 6 Events From the Diagnostics menu select Events to open the Events log Figure 78 An event is defined as any action that occurs with the instrument including but not necessarily limited to System errors Settings changes User added or ...

Page 53: ...er screen 7 8 LCD From the Diagnostics menu select LCD to open the LCD diagnostics screen Figure 80 From the LCD screen you can initiate a pixel test to check the screen for dead pixels of various colors You can also test the LCD backlight using the brightness test slider Tap Exit to return to the Diagnostics menu Figure 80 LCD screen 7 9 Solenoid From the Diagnostics menu select Solenoid to open ...

Page 54: ...rocedure that is not detailed in this User Guide Service or maintenance procedures that are not included in this User Guide should be performed only by a qualified service technician Service or maintenance procedures that are detailed in a Service Manual should be performed only by a qualified service technician 8 2 Issues that require a service technician If the product requires service for any o...

Page 55: ... is used daily Clean the solenoid monthly If the instrument is used only occasionally Clean the solenoid every three months This area of this instrument comes into contact with biohazardous materials Take appropriate precautions 1 Open the section of instrument housing that contains the printer to access the solenoid in the Osmo1 Figure 82 Figure 82 Access the solenoid assembly inside Osmo1 2 Inse...

Page 56: ...ing spring retainer and any washers to the solenoid body Screw in the retainer bracket screws Replace the instrument cover and remove the chamber cleaner 9 If necessary re calibrate the Osmo1 Fuse replacement Tools required Small flat screwdriver Static Grounding Wrist Strap WARNING Hazardous Voltage WARNING Internal components may be damaged by static electricity CAUTION Improper connections may ...

Page 57: ...r into the back of the instrument 7 Close the Fuse Holder Door 8 Reconnect the power cord to the Osmo1 and plug it into an outlet 9 Power on the Osmo1 Sampler plunger wire replacement and verification To ensure proper instrument operation you should replace the sampler plunger wire every 500 tests or each time you empty a Micro Sample Test Kit NOTE A sampler plunger wire is included with each Micr...

Page 58: ...ibration gauge and key back into the top of the sampler Your 20 μL sampler is now calibrated and ready to use NOTE For best results follow the instructions under Verifying the sampler calibration on page 58 to confirm that the sampler is calibrated correctly Fixing a too tight fit 1 Place the wire end into the back end large diameter of the sampler tip Figure 89 Sampler tip Sampler plunger wire ti...

Page 59: ...lean the plunger and then try a new sample If the error occurs again refer to Table 11 below for a possible remedy Error Possible cause Suggested action Out of range Low Out of range High Cause The sample might be outside the range of the instrument Out of range Low indicates the measured reading is below 10 mOsm Out of range High indicates the measured reading is above 2200 mOsm Action Test a con...

Page 60: ...ications Protection class I Over voltage category II Pollution degree 2 Moisture protection IPX0 ordinary Communications USB 2 0 Type A ports 2 USB 2 0 Type B ports 1 Ethernet 10 100 RJ45 connector 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 20 C to 45 C 4 F to 113 F Dimensions D x W x H Not including Micr...

Page 61: ... between 400 and less than 1500 mOsm kg H2O 1 SD 1 from nominal value from 1500 to 2000 mOsm kg H2O 1 SD NOTE For more information about accuracy see Interpreting results on page 8 Accuracy with Clinical Samples Accuracy of the Osmo1 was assessed by a method comparison study between the Osmo1 and the 3320 osmometer according to CLSI EP09A A3 Measurement Procedure Comparison and Bias Estimation Usi...

Page 62: ...ssing Bablok Regression Analysis Results Intercept Slope Lower 95 CI Estimate Upper 95 CI Lower 95 CI Estimate Upper 95 CI Osmo1 1 2 388 1 000 0 232 0 997 1 000 1 003 Osmo1 2 1 186 0 112 0 675 0 999 1 001 1 004 Osmo1 3 0 667 0 189 0 591 0 996 0 998 1 000 Within Run Repeatability1 AI standards and reference solutions Standard deviation 2 mOsm kg H2O between 0 and 400 mOsm kg H2O Coefficient of vari...

Page 63: ...ated in urine by filtration Samples with air bubbles do not freeze reliably and may yield inaccurate results Samples allowed to evaporate will yield higher osmolality values Non aqueous solutions will not yield accurate results The Osmo1 is intended to test aqueous solutions only Highly viscous solutions may not freeze reliably and may yield inaccurate results High concentrations of ethanol aceton...

Page 64: ...ing 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 This symbol indicates the product is an In Vitro Diagnostic Medical Device complying with EU Directive 98 79 EC This symbol indicates the product conforms to the requirements of EU Directive 2012 19 EU on Waste Electrical and Electro...

Page 65: ... Directive Consult the Declaration of Conformity certificate shipped with the product if required for the latest update EC Declaration of Conformity IVD This product meets the intent of Directive 98 79 EC for In Vitro Diagnostic Medical Devices Consult the Declaration of Conformity certificate shipped with the product if required for the latest update FCC Part 15 Subpart B C Class A This device co...

Page 66: ... Instruments are listed with the U S Department of Health and Human Services Food and Drug Administration as Osmometer Class 1 Calibrators Class 1 Controls Class 1 Health Canada The Osmo1 and the calibrators and controls manufactured by Advanced Instruments are licensed with Health Canada Therapeutic Products Directorate Medical Devices Bureau as Osmo1 Class 2 Calibrators Class 2 Controls Class 2 ...

Page 67: ...the host computer to transmit patient work orders to the Osmo1 and accept test results transmitted from the Osmo1 The host work orders provide sample information to the Osmo1 including which test to perform The Osmo1 can be configured to automatically transfer available results to the host or manually transfer results to permit the operator time to review the data In bi directional mode the Osmo1 ...

Page 68: ...ying 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 cases t...

Page 69: ...e the responsibility of the user MODEL NUMBER _____________ SERIAL NUMBER _____________ INSTALLATION DATE _____________ 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 IN ANY MATTER FOR ANY REMOTE OR CONSEQUENTIAL DAMAGES RESULTING FRO...

Page 70: ...onnel if advised immediately by the user of the occurrence of any accident The user warrants 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 th...

Page 71: ...upplied 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 re...

Page 72: ... rights reserved Under copyright laws this guide may not be reproduced in any form in whole or part without the prior written consent of Advanced Instruments 2021 Advanced Instruments Osmo1 is a trademark of Advanced Instruments All other trademarks are the property of their respective companies The management system governing the manufacturing of this product is ISO 9001 and ISO 13485 registered ...

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