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Appendix D

Regulatory notices

Osmo1

™

Single-Sample Micro-Osmometer Service Guide

Regulatory
approval type

Description

USFDA Listing

The Osmo1 and the calibrators and controls manufactured by Advanced 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

Содержание Osmo1

Страница 1: ...Osmo1 Single Sample Micro Osmometer Service Guide 133006EN Rev 0 ...

Страница 2: ...nstruments 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 im...

Страница 3: ...eling the entire calibration 24 4 5 Calibration errors 24 Chapter 5 Settings 25 5 1 Accessing the Settings menu 25 5 2 Logging in to a Settings function 26 5 3 Timing out of a Settings session 26 5 4 Default user accounts 26 5 5 Setting date and time 27 5 6 Setting language 27 5 7 Setting up user accounts 27 5 8 Adjusting hardware options 28 Setting audio options 28 Adjusting screen brightness 28 ...

Страница 4: ... General errors 41 8 2 Errors during calibration 41 8 3 Errors during testing 41 8 4 Electro mechanical problems 42 Appendix A Product specifications 43 Appendix B Performance characteristics 44 Appendix C Known limitations 45 Appendix D Regulatory notices 46 Appendix E Supplemental LIS LAN information 49 Appendix F Product disposal and recycling 50 Appendix G System schematic 51 Appendix H Osmo1 ...

Страница 5: ... 0811 Outside the US or Canada Phone 1 781 320 9000 Fax 1 781 320 0811 Email techsupport aicompanies com NOTE When contacting Advanced Instruments for technical support please be ready to provide the service technician with the model and the serial number of the instrument as well as a general description of the problem It may be necessary to perform diagnostic checks during the service call so pl...

Страница 6: ...ine 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...

Страница 7: ... 133059R 133059PM Sample Probe 133060R 133060PM Sample Probe Cable 133061R 133061PM Cooling Fan Assembly 133062R 133062PM Power Supply 133063R 133063PM Power Entry Module 133064R 133064PM Thermal Printer 133065R 133065PM RFID Reader 133066R 133066PM Fuses two required 133072R 133072PM Sample Handling Assembly 133300R 133300PM Cooling Assembly 133310R 133310PM Cradle Switch 133076R 133076PM IMPORTA...

Страница 8: ...e product 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...

Страница 9: ...dropped or damaged by a falling object There are noticeable signs of overheating or a burning odor The product does not operate normally when you follow the operating procedures The main supply fuse s or any internal fuse s continually fail When servicing the product use only factory specified parts To avoid injury or fire hazard do not operate this product in an explosive atmosphere Use caution a...

Страница 10: ...ersons This symbol alerts the user to the presence of internal components that could be damaged by static electricity This symbol alerts the user 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 c...

Страница 11: ...he 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 équipemen...

Страница 12: ...gate low sodium levels hyponatremia to detect the presence of toxins in the body and to monitor osmotically active drug therapies such as mannitol which is used to treat cerebral edema This test is also ordered to help monitor the effectiveness of a treatment for a condition found to be adversely affecting a person s osmolality Osmometers test virtually any biological fluid including but not limit...

Страница 13: ...he Osmo1 contains four major components Figure 3 on page 14 Sample Handling Assembly This module is the part of the osmometer where testing is performed The sample probe cooling assembly and actuator switch are monitored and controlled by the sample handling assembly Power Supply Control Assembly This component provides power to the instrument via the fused power inlet assembly The Control PCB con...

Страница 14: ...vates when an object trips the scanner s proximity sensor The sensor has built in red illumination LEDs to help read barcodes in low light conditions Thermal printer port This port communicates to a thermal printer module Seiko DPU D3 00A E via 115 Kbps 1 start bit 1 stop bit and no parity protocol RS 232 driver circuits The instrument uses three RS 232 ports Communication to display PCB Communica...

Страница 15: ...ast one thousand sample records The control PCB has non volatile memory used to store instrument set up calibration and other pertinent data Real time clock The display PCB has a real time clock and a back up battery to maintain the date time and firmware versions The instrument uses three proximity sensors to determine the presence of sample tubes objects near the barcode scanner thermoelectric m...

Страница 16: ...nstrument must be located within five feet of a properly grounded three prong electrical outlet capable of continuously supplying 0 5 amperes at 100 240 VAC 50 60 Hz If the instrument is not grounded properly its operation may be impaired and a safety hazard may exist Verify that the outlet is appropriate before operating the instrument Do not disable the grounding plug 2 2 Loading the printer pap...

Страница 17: ...ded door closed 2 3 Placing the Micro Sample Test Kit on the instrument The Micro Sample Test Kit contains a supply of consumables required for testing 500 chamber cleaners 500 sampler tips and one plunger wire A Micro Sample Test Kit must be in place on the top left of the instrument before testing can begin As shown in Figure 7 the box must be oriented so that The photo of the instrument and the...

Страница 18: ...cation on page 30 and Configuring a LAN connection on page 31 2 5 Powering up the instrument 1 Connect the power cord to the back of the instrument Figure 2 on page 13 and insert the plug into the power outlet 2 Power on the instrument using the rocker switch on the back NOTE Press the side marked with the symbol When the unit powers up the Welcome screen displays Figure 8 Figure 8 Osmo1 Welcome s...

Страница 19: ...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 3 2 Common screen elements Table 1 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...

Страница 20: ...rcode 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 Assigning restrictions on page 33 Example of a warning message Tap to display the Main menu Table 2 Items on the Home screen Enter sample ID Display Main menu Progress bar Warning message Latest test Fi...

Страница 21: ...act 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 ...

Страница 22: ...ces where calibration is recommended or required based on the regulations that govern the 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 H2O calibration standards 3 point calibration uses the 50 850 and 2000 mOsm kg H2O calibra...

Страница 23: ...libration in progress Figure 17 Two replicate failures error message Figure 18 Calibration successful message 6 Click OK to close the success or failure message When you close a success message the system returns you to the Home screen When you close a failure message the system clears all checkmarks and returns you to the Calibration screen Figure 15 From there you can restart the calibration or ...

Страница 24: ...vent 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 variation in the replicates for the calibrator group Action Confirm good technique Confirm sample handler is in good condition Check for particulates in sample Out of range Low Out of range High Cause The result for the ...

Страница 25: ...ties related to system updates system resets troubleshooting and database management Restrictions Set operator level access Set password expiration period Change number of calibration points Enable disable requirement to enter the User ID and Sample ID for testing Table 6 Functions available from the Settings menu To access the Settings menu 1 From the Home screen tap the menu icon Figure 21 Figur...

Страница 26: ...he menu NOTE Each function available from the Settings menu is described later in this chapter 5 3 Timing out 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 ...

Страница 27: ...ed date and time format 5 Tap Save to save the changes 6 Tap Exit to return to the Settings menu NOTE If the system detects unsaved changes it asks if you want to save changes before exiting 5 6 Setting language The language is set at the factory before the unit ships You might need to change the settings to suit the site To change the language 1 From the Settings menu tap Language The system prom...

Страница 28: ...tep 3 and step 4 for any other hardware options you want to view edit 6 When you have finished viewing editing hardware options tap Exit to return to the Settings menu Setting audio options Audio beeps can alert you to error conditions You can disable or set options for audio click tones and then test your selections using the Audio tab on the Hardware Options screen Figure 29 After changing setti...

Страница 29: ...e settings tap Save Figure 32 Barcode scanner options screen 5 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 change to the sample or block probe resistance you must recalibrate the Osmo1 1 From the Settings menu tap Probe Resistance The system prompts you to log in 2 Select the Admin user and ent...

Страница 30: ...reen shows a successful and ready LIS connection Gray shows a disabled LIS connection Red shows a disconnected or error condition on the LIS connection Configuring the LIS connection To set up the LIS connection 1 From the Settings menu select LIS LAN The system prompts you to log in 2 Select the Admin user and enter the appropriate password The LIS LAN screen displays with the LIS tab in front Fi...

Страница 31: ...ts assign the Osmo1 a static IP address 5 Enter the IP address subnet mask and default gateway in the designated fields NOTE Tap the keyboard icon beside each field to display a numeric keypad Use the keypad to enter the value then tap Enter to close the keypad and return to the LAN tab 6 Tap Save to save the LAN settings 7 Tap Exit to return to the Settings menu 5 13 Managing the system The Admin...

Страница 32: ...abase Use the radio buttons to select the option you want to export then insert a thumb drive into the USB port on the back of the Osmo1 and tap Export 5 If you want to clear a database Select the table Results Events Users or Controls then tap Clear CAUTION Clearing databases deletes the data and it cannot be recovered Be sure that you want to do this before tapping Clear 6 When you are finished ...

Страница 33: ...buttons To access the Diagnostics menu 1 From the Home screen tap the menu icon Figure 39 Figure 39 Menu icon The Main menu displays Figure 40 Figure 40 Osmo1 Main menu 2 From the Main menu tap Diagnostics The Diagnostics menu displays Figure 41 Figure 41 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...

Страница 34: ... are finished working on this screen tap Exit to return to the Diagnostics menu 6 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 17 From the Diag...

Страница 35: ...f the barcode scanner If successful the system beeps and the barcode information displays on screen Tap Exit to return to the Diagnostics menu Figure 45 Barcode screen 6 6 Events From the Diagnostics menu select Events to open the Events log Figure 46 An event is defined as any action that occurs with the instrument including but not limited to System errors Settings changes User added or deleted ...

Страница 36: ...ter screen 6 8 LCD From the Diagnostics menu select LCD to open the LCD diagnostics screen Figure 48 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 48 LCD screen 6 9 Solenoid From the Diagnostics menu select Solenoid to open...

Страница 37: ...odically wipe the instrument with a barely damp cloth Use either warm soapy water or isopropyl alcohol to dampen the cloth Make sure the fan on the back has not accumulated dust and debris that could impede air flow Dirty air vents can cause instrument overheating and reboots Complete other service to the Osmo1 following instructions in this section Chamber cleaning If you experience multiple Samp...

Страница 38: ...unger hole until it reaches the chamber cleaner you inserted in step 2 Move the applicator in and out to scrub the sides of the hole 6 Clean the smaller diameter plunger of the solenoid assembly with a 70 isopropanol solution on a soft cloth Do not use any abrasive for this cleaning procedure 7 Inspect the solenoid plunger for excessive wear and deposits If the plunger shows signs of fouling Figur...

Страница 39: ...h Micro Sample Test Kit Failure to replace the plunger wire may affect instrument accuracy and repeatability NOTE Refer to Figure 54 when completing the sampler plunger wire replacement procedure Calibration gauge key Shaft bushing Shaft Finger grip Body Calibration set screw access Sampler tip Key Wire Tip Figure 54 Sampler plunger To replace the sampler plunger wire 1 Unscrew the calibration gau...

Страница 40: ...all the sampler plunger wire and tighten 3 Move the sampler tip in a back and forth motion over the plunger wire and tip until the fit is acceptable 4 Remove both parts and re assemble normally Verifying the sampler calibration Perform this verification procedure after you replace the sampler plunger wire or any time you want to confirm that the sampler is calibrated correctly 1 Place a new sample...

Страница 41: ...ors during testing Table 10 lists errors that can occur during a test If an error occurs during a test a message displays on the screen and is recorded in the events database Discard the sample carefully clean the plunger and then try a new sample If the error occurs again refer to Table 10 below for a possible remedy Error Possible cause Suggested action Out of range Low Out of range High Cause T...

Страница 42: ...odule Use a small screwdriver to pry out the fuse holder Visually check the two 5 mm x 20 mm fuses for a blown fuse If there is any doubt test the fuses with a continuity checker or ohmmeter or simply replace them see Replacement Procedure 133072PM in Appendix I Also check the values marked on the fuses to make sure that they are the correct rating for the product If a fuse was blown and a replace...

Страница 43: ...ns Protection class I Over voltage category II Pollution degree 2 Moisture protection IPXO 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 Micro Samp...

Страница 44: ...acy1 AI standards and reference solutions 2 mOsm kg H2O from nominal value between 0 and 400 mOsm kg H2O 1 SD 0 5 from nominal value between 400 and less than 1500 mOsm kg H2O 1 SD 1 from nominal value from 1500 to 2000 mOsm kg H2O 1 SD Within Run Repeatability1 AI standards and reference solutions Standard deviation 2 mOsm kg H2O between 0 and 400 mOsm kg H2O 1 SD Coefficient of variation 0 5 bet...

Страница 45: ...inated 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 acet...

Страница 46: ...ting 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 Electr...

Страница 47: ...s of article 3 2 of Directive Consult the Declaration of Conformity shipped with the product if required for the latest update EU 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 shipped with the product if required for the latest update FCC Part 15 Subpart B C Class A This device complie...

Страница 48: ...ed 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 ...

Страница 49: ... 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...

Страница 50: ...ing 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 th...

Страница 51: ... 8181 SCHEMATIC SYSTEM INTERCONNECT OSMO1 D 0 N A N A S SELVAMANI 06 19 2017 THIS DOCUMENT CREATED USING OrCAD CAPTURE V17 2 REFERENCE PROJECT FILE AN3000SC OPJ AND ASSOCIATED FILES 1 1 133000SC DFT CHKD APPD SCHEMATIC NEXTASSY SHEET SCALE DWG NO SIZE REV OF GROUND SYMBOL LEGEND SIGNAL RETURN A CURRENT CARRYING SIGNAL OR POWER RETURN CONNECTION SAFETY GROUND A CONNECTION TO AN ELECTRICAL GROUND ST...

Страница 52: ...tacting Advanced Instruments on page 5 The distributor or dealer may have applied additional local national or international approvals to this product Consult the distributor or dealer for more information and documentation Osmometer model Osmo1 Single Sample Micro Osmometer Serial number Symptom or problem Repairs replacements or changes Serviced by Date ...

Страница 53: ...Appendix H Osmo1 service log 53 Osmo1 Single Sample Micro Osmometer Service Guide Symptom or problem Repairs replacements or changes Serviced by Date ...

Страница 54: ...023PM Osmo1 Cradle Switch Cable 133037PCPM Osmo1 Control PCB 133058PM Osmo1 Block Probe 133059PM Osmo1 Block Probe Cable 133060PM Osmo1 Sample Probe 133061PM Osmo1 Sample Probe Cable 133062PM Osmo1 Cooling Fan Assembly 133063PM Osmo1 Power Supply 133064PM Osmo1 Power Entry Module 133065PM Osmo1 Thermal Printer 133066PM Osmo1 RFID Reader 133072PM Osmo1 Fuses 133300PM Osmo1 Sample Handling Assembly ...

Страница 55: ...ced in any form in whole or part without the prior written consent of Advanced Instruments 2018 Advanced Instruments Osmo1 is a trademark of Advanced Instruments All other trademarks are the property of their respective companies 133006EN Rev 0 The management system governing the manufacturing of this product is ISO 9001 and ISO 13485 registered IVD Two Technology Way Norwood MA 02062 For more inf...

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