intended use of the human milk analyzer
Contents
1. instrument if the instructions are followed carefully eThe HMA is intended for non diluted breast milk without any chemical additives except for the preservative Bronopol If the purpose is to analyze diluted milk a special calibration is required elt is not intended to measure the nutritional content of any other liquid for example fortified human milk or infant formula This is due to that fortifiers and instant formulas use hydrolyzed proteins and thus this will lead to wrong results TECHNICAL SPECIFICATIONS Dimensions HxWxL Weight Power supply Adapter Power supply Instrument Battery PC connections Display Measurement temperature Internal Storage capacity Backup of measurement data Operative system Measurement performance Components tested Shown value Time for analysis Analytical method Standards ENVIRONMENTAL Temperature Humidity Pressure ENVIRONMENTAL Temperature Humidity Pressure 9x26 x 31 cm 3 kg Input voltage 100 240 V 50 60 Hz 2 3A Output voltage 18 V 100VA Li ion battery to keep date and time lifetime gt 10 years USB B for transfer of results and software update via ActiveSync or Windows Mobile Device Center USB A for memory stick and devices e g keyboard mouse scanner etc RS232 and Ethernet TTFT QVGA 320 240 40 C 104 F 4000 measurements Internal persistent flash memory Windows Compacts 7 Repeatability lt 0 05 units Accuracy SD lt 0 12. Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 8 RESULT REVUE This chapter describes how results can be shown on the instrument display saved on a USB memory stick and exported from the instrument to a PC The memory of the instrument can save approximately 4000 measurements VIEW LAST RESULTS In the menu View it is possible to see the results from previous measurements Open the menu Result and then View To exit the menu press Finished PICTURE 51 Results viewer screen The first screen shows a summary of the last actions performed by the instrument Number of Measurements Checks Adjustments Slope Bias Resets Choose what to be shown by marking ID Index Date and Time PICTURE 52 Detailed picture of how to choose information visible in the results table Choose how many results to be shown 32 Document name Document number df NIE User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA PICTURE 53 Detailed picture illustrating how to change number of samples in the results table MEASUREMENTS To see results from measurements press M PICTURE 54 Measurements The results will be presented in a table scroll to see all results Calib O means unprocessed milk and calib 1 means homogenized milk PICTURE 55 Results presented in a table scroll
3. 0 ABS Kalki Wt 11 6 25 50 3153 i D AES Kalas Indes002 ASE rm net AYISI ATIF AM Check values Ts fe Gallatin HRA urun Za 00506 Af 463207 i515 6 5 72 5 654 1005236 Ase 4635 07 IOE 75 71 MDE 15 23 43 am 0 HALE npn mik 1E wires Reset Tih META Pet o HATA unpre mik YVE SFE hiria 10 IU A i Hai unpre ik VE Soe Ao SS AR HAS Winns milk V 3201 Mindet 4 25 2011 19 35005 Ard IAT ieee ER IL 15 25 08 Ar 0 Hea unproccsscd milk WE H TANN G rle AAT 1A Are i 0 Calibration name JAM Mirai KIL let A SDS Miia ASOT 1439 AR Hlk unprocessad milk Vi I MeL LL 10 42 50 AM E HS uri mik WE 107 Girish AAL 10 49 30 AM Calibration HMA homopentred mik 1 NAM aA A T NAM 1 n n 47 1 n AKILO O T515 K U HB BA alar s releri Afili 12906015 Fr i 4 5 1 4 Bi HA homoperuded elk WL 3200 Aline li 1507 45 Pre i 3 4 il 117 65 HLA homogenized milk WC 1211 Mine 2425 2011 1308 53 Pie 1 3a LI 12 7 E HAA homogenized milk WE 1212 res MILE 425 120029 FRA i J LI 12 59 Lia Has homogenized milk VI ATO Miata aay VTS FRA 1 14 1 1 TAK BA HAM hromupersseil silk VE Fii ire dizi 121153 Fr i J 11 12 6 E5 Ha hormioperuasd malk wE SS kid li LA Pte 1 3 4 il ILLE 65 HeLa homoponized milk WE JALE Minden HALL 1533 FA I Ja 1 12 7 ira HMA homogenized milk WE IIET kee An TT Pied PM T an 11 11 FM LWP Pr rr r naritali malk Wr ga indsxon19 4 3 CE Ay iJe Cindes odO ay at Protein Carbohydrate TS Energy Id 1 7 12 5 68 3 7 1 1 71
4. units Fat g 100ml Protein g 100ml Carbohydrates g 100ml Total solids TS g 100ml Energy kcal 100 ml 1 decimal 60 seconds measurement Mid infrared transmission spectroscopy CE class B LVD FCC Medical device OPERATIONAL 15 C 59 F to 35 C 95 F 10 80 not condensed 3 657 60 m max NOT OPERATIONAL freight empty cuvette 0 C 32 F to 50 C 122 F 20 80 not condensed 12 192 m max 1 Samples from 20 C can be used For optimum results preheating the samples to 40 C 104 F is recommended 12 Document name Document number MIRES User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 1 INSTALLATION Screen Outlet Inlet Buttons PICTURE 1 HMA front Power connector Reset Computer connection OPTIONAL RS232 Computer connection USB A 9 Computer connection USB B 10 Ethernet 11 On off button o0000000000099 m lsfl e 7 ele PICTURE 2 HMA back 5 Ethernet 10 Z USB 8 and 9 ee Power connector DC 5 13 Document name Document number M NINE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA SE at pa In and outlet parts amp Y 1 f Inlet parts Filter gasket o ring red or black Filter washer stainless PICTURE 3 Inlet 11 e Outlet p
5. number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Reference sample adjustment The instrument is calibrated according to ISO 9622 standard reference methods Miris guarantees the specification only using ISO 9622 standard reference methods that are used upon delivery of the instrument If you want the instrument calibrated against any local reference methods you have to run analysis on your reference samples and calculate a slope value according to instructions in the user manual chapter 10 Slope amp Bias Please also see information in chapter 10 on how to make the settings on your instrument Note that it is very important that you perform the analysis according to the instructions in order to avoid wrong settings due to poor sample preparation Your chosen reference samples should not be frozen and nor used repeatability for future measurements Adjust the instrument to local reference samples See Slope Bias setting See page 45 The average of at least three reference samples should be used 25 Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA IDENTITY OF SAMPLE Each sample or sample batch can be given a unique ID max 20 characters which will stay the same until changed Every sample will also get a four digit index nu
6. start PICTURE 31 Preparation of the system PICTURE 32 Analyzing the sample PICTURE 33 Result presented on the screen ready when the text in the boxes appears To analyze a new sample change ID according to instructions if necessary inject the next sample and press start Clean the instrument every ten samples when intending to leave it for more than five minutes or when finished for the day See separate chapter with cleaning instructions It is possible to analyze a maximum of ten milk samples after each other without cleaning in between It is very important to NEVER LEAVE MILK IN THE INSTRUMENT MORE THAN FIVE MINUTES 27 Document name Document number dl MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA Chapter 7 HMA CLEANING ROUTINE eClean the instrument every ten samples or when intending to leave the instrument for more than five minutes Do not use any other cleaning detergent than correctly diluted Miris Clean solution warmed to 40 C The reason for pre warming is to make the cleaning more efficient Place the waste tube on the inlet elnject at least 10 ml of Miris Clean in the outlet port reversed fluid direction BILD ePut the waste tube back on the outlet and inject at least 5 ml Miris Clean in normal fluid direction eAlways perform a check as described under CHECK on page 8 elf you are done f
7. thawed milk which was prior frozen see Frozen Milk below ePerform a zero setting check see CHECK below eGive the sample a unique identity if needed eWarm the sample in a water bath to 40 C and mix carefully do not shake vigorously or vortex to avoid introduction of air bubbles elnject ca 2 ml for single measurement into the instrument leaving some milk in the syringe and the syringe on the inlet during the analysis i e Press START eThe result is presented on the screen after approximately one minute eContinue analyzing the next sample or clean the instrument Cleaning has to be done after every 10th sample or when the instrument is not in use for more than five minutes Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Frozen Milk Frozen human milk is thawed overnight in a refrigerator or in a water bath at 40 C The thawed human milk has to be homogenized see Frozen Milk on page 6 This is done with the aid of an ultrasonic homogenizer For each ml of human milk sonication exposure is 1 5 sec with amplitude of 70 full scale using a micro tip This calculates to an energy input of approximately 20 J sec per ml of human milk CHECK Perform a check in order to ensure that the instrument is zero set This function initiates a validation of the linearity or instrument calibration and zero setting Inject at least 5 ml MI
8. the instrument the first time TO LOG IN 1 Mark the correct rights box The ID will automatically change PICTURE 14 Admin PICTURE 15 Operator PICTURE 16 Guest 2 Choose a user from the list The user name is only a signature It will give the opportunity to see who has done the measurements See Appendix 2 for information on how to create a user list PICTURE 17 Default user list 17 Document name Document number Saf NI EN User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA 3 Turn the keyboard on PICTURE 18 Detailed description of where to turn the keyboard on and off 4 Type in the password and turn off the keyboard PICTURE 19 and 20 Type in the password and turn off the keyboard The default passwords are Admin Admin Operator Operator Guest Guest NOTE The passwords are shift sensitive See Chapter 9 SETTINGS for information on how to change the passwords See Appendix 3 for information on how to remove the log in function 5 Press OK The instrument will now start up 18 Document name Document number W ANAE User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 3 MIRIS CLEAN AND MIRIS ZERO CHECK MIRIS CLEAN Dilute 1 tube 10 ml with 490 ml distilled or deionized water Storage room temperature D
9. the outlet and inject at least 5 ml Miris Clean in normal fluid direction eAlways perform a check as described under CHECK on page 8 elf you are done for the day perform filter cleaning see User Manual inject distilled or deionized water and leave the system closed A gt 4 l Y gt A j LS N NOTE If it is hard to inject the cleaning fluid in reversed direction it is most likely due to the outlet stop gasket see User Manual Document name Document number MILES User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA WARRANTIES AND DUTIES By accepting and operating this Human Milk Analyzer the USER and MIRIS agree to the following responsibilities which constitute contractual warranties and condition between MIRIS and USER for the maximum benefit and usefulness of the Human Milk Analyzer MIRIS AB WARRANTS THAT IT e Knows of no defects in the construction of the HMA or its materials used e New revisions of this manual will be published at www miris se e Will replace or repair the Human Milk Analyzer according to the guarantee in the warranty USER WARRANTS THAT e Validation and adjustment of the calibration will be done against references valid in each country e The Human Milk Analyzer will be used according to the instructions given in the user guide e The Human Milk Analyzer will not be al
10. to see all information 33 Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstrom 2012 12 10 CHECKS To view performed checks press C PICTURE 56 Checks The checks will be presented in a table scroll to see all information PICTURE 57 Results from performed checks scroll to see all information 1 0 02 001 3 5 HMA 34 Document name Document number df NIE User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA ADJUSTMENTS TO ZEERO LEVEL Press Z to see adjustments that have been done PICTURE 58 Date and time of performed adjustments Scroll to see all information in the table PICTURE 59 The entire adjustment table 35 Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA SLOPE BIAS Press SB to view slope and bias settings that have been done PICTURE 60 Slope and bias presentation The slope and bias settings that have been done will be shown in the table scroll to see all information for each parameter Slope is the first number in this example 1 0000 and bias is the second number in this example 0 0000 see picture 61 PICTURE 61 Detailed slope and bias information 36
11. using the spanner PICTURE 38 Remove the inlet o PICTURE 40 Gasket removal F PICTURE 39 In and outlet underside Daily cleaning of filter Follow step 1 3 in inlet cleaning routines page 30 The stainless filter can be soaked in MIRIS CLEAN for at least 12 hours and rinsed before use 29 df NIE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA INLET CLEANING ROUTINES PICTURE 41 45 PICTURE 42 2 Open the inlet 3 Carefully remove the gasket and the filter MOST IMPORTANT PART TO CLEAN HINT Use a small screwdriver or toothpick if it is difficult to remove the gasket PICTURE 44 4 Separate the parts clean rinse with water and remount all the parts reverse order 30 Document name Document number MIRIS User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA OUTLET CLEANING ROUTINES PICTURE 46 50 1 Remove the outlet from the instrument use the spanner if needed PICTURE 47 2 Open the outlet PICTURE 48 3 Carefully remove the stop gasket Ceo PICTURE 49 PICTURE 50 4 Separate the parts clean rinse with water and remount all the parts reverse order 31 Document name Document number df NIE User Manual HMA Prepared by Approved by Date
12. 0 C 32 F must always be done with the cuvette empty e Never open the instrument Breaking of the void seal will invalidate the warranty e Always leave the instrument filled with de ionized or distilled water when not in use and make sure the system is closed e Secure that the in and outlet ports are in place in order to avoid dirt entering the cuvette e Always leave the protective cap covering the RS232 connection when not in use e Never use any other power supply than ADAPTER ELPAC POWER SYSTEMS MODEL MWA10018A 12 Input voltage 100 240 V 50 60 Hz 2 3A Output voltage 18 V 100VA MIRIS AB can only guarantee the function and performance of the HMA when it is properly used and maintained as indicated If the recommendations above are not followed the accuracy and function of the instrument will be jeopardized MIRIS AB has the right to amend develop and or change the program without further notice should the need arise Functions described in this manual may be altered removed or rebuilt in later versions of the software 11 Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA INTENDED USE OF THE HUMAN MILK ANALYZER eThe Human Milk Analyzer HMA is an analytical instrument for the direct determination of the nutritional content fat protein and carbohydrates of human milk MIRIS AB can only guarantee the performance of the
13. 12 9 67 36 1 fel 12 9 or 3 7 1 1 AL 13 1 68 3 6 1 1 Fr 13 1 68 3 8 1 1 7 2 13 2 69 38 LI Aal 13 2 69 3 7 1 1 AL 13 68 Figure 4 Excel explanation 52 Document name Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Appendix 2 Creating a user name list Connect the instrument to a PC using a USB cable same procedure as when transferring results Open BIN Copy the file userlist txt to the computer Add or change user id Save the file and paste it back in BIN Restart the instrument NOTE There are three log in levels with different instrument access rights administrator operator and guest The user name however is only a signature giving the opportunity to see who has done the measurements 53 Jf NIE User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Appendix 3 Removing the log in function The log in function can be turned off either by going into the menu About User when logged in as an administrator or on the initial screen 1 Mark the box Admin PICTURE 96 Log in screen 2 Turn the keyboard on PICTURE 97 Keyboard on 3 Type in the password and turn off the keyboard PICTURE 98 and 99 Type in the password 54 4 5 Document name Document number df NIE User Manual HMA Prepared by App
14. A Safety Aspects on Human Milk Human milk has to be considered as potentially infectious even though donor mothers might have been serologically screened negative for e g HIV and Hepatitis B and C The local legislation and procedures for handling human milk have to be respected and the personnel instructed for compliance Where no such framework or guidelines exist we recommend following strict safety measures Lab coats safety glasses and gloves should be worn at all times when handling human milk Single use plastic ware and waste analyzed human milk should be autoclaved before disposal Bottles and glassware should be rinsed with a disinfectant capable of inactivating infectious agents before washing in for example a laboratory dishwasher Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Milk Collection and Handling Before starting to analyze it is important to ensure good routines regarding milk collection handling sampling for analysis and in the case of milk which was frozen prior to the analysis homogenization Milk collection for analysis should be performed under standardized conditions e g 24h collection one complete breast sample or fore hind milk sample If local guidelines exist they should be followed If the intention is to use the HMA in a clinical research setting a clinical study protocol defining the milk collection pro
15. Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA RESET Press R to see when the instrument has been reset PICTURE 62 Information about instrument resets Scroll to see all information PICTURE 63 Date and time when reset has been done 37 Document name Document number TE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA TRANSFER THE RESULTS Open the menu Results To save the results on a USB memory stick 1 Connectthe USB memory stick 2 Press Transfer 3 The results file will automatically be saved on the memory stick as a text file txt with the name result_datetime txt In the example in picture 64 date is June 3 2009 and time 10 59 24 For information on how to convert the text file into an Excel file please see appendix 1 SETTE 12588 er Lie EPER EEE PICTURE 64 Result menu If transfer is pressed without a USB memory stick connected the following message will be shown PICTURE 65 Result transfer failure 38 Document name Document number Saf NIE TS User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA TRANSFER RESULTS DIRECT TO COMPUTER Depending on the operative system Windows VI
16. O NOT FREEZE Best before 1 year unopened tube use dilution within 3 months MIRIS ZERO CHECK Dilute 1 tube 10 ml with 90 ml distilled or deionized water Storage refrigerator 4 8 C Best before 1 year unopened tube use dilution within 3 months 19 Document name Document number M NINE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 4 OPERATING THE INSTRUMENT When turning on the instrument the program starts up with the licensed application software and the following main menu see picture 21 The instrument is ready to operate after an initial warming period taking a few minutes the display will read Ready Press a button PICTURE 21 Main menu Basic principles This instrument can be used as a standalone unit or with USB accessories such as mouse external keyboard barcode reader and printer There is only one USB A connection but it is possible to connect a USB hub allowing use of several units at the same time MIRIS recommends using a mouse for most convenient operation of the instrument especially settings such as date time and slope bias adjustments The instrument can however be operated by only using the buttons to navigate the cursor see picture 1 By clicking with the mouse or pressing the instrument s buttons operation is straightforward following the instructions on the screen The menu open
17. RIS Check warmed to 40 C into a cleaned instrument Leave the syringe on the inlet and leave some of the solution in the syringe Press check The check procedure takes approximately one minute and when the process is completed a pass or fail message will appear If the check passes Result is within 0 05 the text No adjustment necessary is shown and the instrument is ready for analysis If the test fails the text Adjustment needed is shown Large deviation may be an indication of a contaminated sample cuvette It is then important to carefully clean the system again Ensure also that the check solution is not contaminated Perform at least two more checks If the check still fails it may be necessary to perform an adjustment of the instrument this is done by pressing the key marked Adjust Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA HMA Cleaning Routine eClean the instrument every ten samples or when intending to leave the instrument for more than five minutes eDo not use any other cleaning detergent than correctly diluted Miris Clean solution warmed to 40 C The reason for pre warming is to make the cleaning more efficient Place the waste tube on the inlet elnject at least 10 ml of Miris Clean in the outlet port reversed fluid direction ePut the waste tube back on
18. STA or XP there are two different procedures Make sure the correct program is installed before starting VISTA requires Mobile Center 6 1 and XP or older requires ActiveSync Instruction VISTA SYNCRONIZE For Windows Vista install Mobile Center 6 1 the software can be downloaded for free at http www microsoft com downloads details aspx Familyld 46F72DF1 E46A 4A5F A791 09F07AAA1914 amp displaylang en Connect the instrument and the computer with the USB cable using the USB B connection In the computer Windows Mobile Device Center starts automatically this may take a while be patient A amp pi Mobile Device Settings PICTURE 67 Press File Management and then Browse the contents of your device 39 1 NIE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Bi mmeti E ite B ver Ais eri Bus Faber Copa boret Det 0 gli DAT Orker I B Rua i lg bby Degree begun Nha Torp Mindcen am FEN File Gwe ar ka ereded dl fer poche Erim a My Berg ider S Mrk re ri Feri T uer d et reps wae 1 Fra EHE KR TAT Sauce ter 20 KE ra a Toin cc 13 FE PICTURE 68 Open ae Cope e Fl e LE Fp rer E Poveda Liki Fires Tam cu delet acd Erari Eser Alp Deer Faye Vin Traa E Firm E ar hk redrisglkbki e met Mirre
19. Wris Human Milk Analyzer USER MANUAL and Quick guide Document name Document number W ANAE User Manual HMA CONTENT ETEN arna E a MM E ie 2 PREFACE EEE E AN MM 3 CICK GUIDE e ae a ee E EEE 4 WARRANTESANDDUT LES eee 10 IMPORTANT SAFELY INFORMATION eria ares ie as rm o ny 11 INTENDED USE OF THE HUMAN MILKANALYZER ll 12 TECHN CAL SPECIFICATIONS arvede 12 Chapter 1 INSTALLATION sacvcsniscecsdecacessreiceonntwsadesisicassacsdesadanebndiincadueateseuadasanadeandedesalstbeadasatedvasdabeesdeoeteslans 13 Chapter 2 LOG IN NNN 17 Chapter 3 MIRIS CLEANANDMIRISZEROCHECK rl 19 Chapter 4 OPERATING THE INSTRUMENT sssusa E 20 Chapter 5 MILK COLLECTMONANDHANDLING er 21 Chapter 6 HUMANMILKANALYSISWITHTHEHMA 22 Chapter HMACLEANINGROUT NE een 28 chomer o RT EY MP Ny 32 Chapter TSE TEN smear lele Selmani EAA 42 Chapter 10 SLOPE AND B A Sakin samdan esna ma 45 Chapter 11 TROUBLESHOOTING AND PROBLEM SOLV NG 49 Chapter 12 WORKING PRINCIPLEOFTHE NSTRUMENT 51 ANLA 52 NNN NNN 53 PIN e A NN E Ve 54 PENN 56 Document name Document number NILENS User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA PREFACE Thank yo
20. ansferred to an external computer and processed for example in a spreadsheet program or printed out This enables the user to take immediate and appropriate decisions based on the results The possibility to perform near patient analysis of breast milk permits individualized nutrition by providing the infant milk of known composition removing the guesswork when using expressed milk READ THE MANUAL BEFORE USING THE INSTRUMENT CONTACT MIRIS AB Kungsgatan 115 753 18 Uppsala Sweden www miris se info dmiris se Tel 46 18 14 69 07 O Copyright 2012 MIRIS AB All rights reserved This manual is protected by copyright Distribution and copying in any form of the content is prohibited without the explicit and written consent of MIRIS AB The trademarks mentioned in this manual are the property of the respective owners Pictures 1 110 Sofia Olsson picture on front page Martina Sjaunja Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA QUICK GUIDE Important safety information Human Milk Analyzer HMA is an analytical instrument intended for direct determination of the nutritional content of breast milk Miris AB can only guarantee the performance of the instruments if the instructions for use are followed carefully Please ensure to read the full User Manual in order to secure proper handling Intended Use of the Human Milk Analyzer eTh
21. arts 7 Valve case stainless 8 Nipple seal EPDM black Filter cover stainless Nipple seal EPDM black 9 Stop washer stainless Filter stainless Valve case stainless der 10 Stop gasket EPDM black 11 Stop cover stainless PICTURE 4 Outlet PICTURE 5 Underside PICTURE 6 Gaskets 14 Document name Document number MIRIS User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Electrical requirements The Human Milk Analyzer requires 12 20 V 100VA Do not use any other adapter than MWA10018A 12 see picture 7 PICTURE 7 Adapter MWA10018A 12 Instrument placement The HMA should be placed in an area free from dust dirt explosives corrosive fumes and extremes of temperature and humidity Place the instrument on a stable work bench or similar Avoid draft and vibrations that can influence the accuracy of results and prolong the analysis time Never place the instrument in direct sunlight which may disturb the function of the instrument If the HMA is permanently connected to a computer or if you use devices please read the device manual for information about placement guidance and electrical security 1 Attach the instrument to a power source according to the instructions below and turn on the instrument by pressing the on off button The licensed application software will automatically start when the inst
22. at the instrument is zero set This function initiates a validation of the linearity or instrument calibration and zero setting Inject at least 5 ml MIRIS Check into a cleaned instrument Leave the syringe on the inlet and leave some of the solution in the syringe see picture 27 on page 19 Press check The check procedure takes approximately one minute and when the process is completed a pass or fail message will appear If the check passes Result is within 0 05 the text No adjustment necessary is shown and the instrument is ready for analysis If the test fails the text Adjustment needed is shown This may be an indication of a contaminated sample cuvette It is then important to carefully clean the system again Ensure also that the check solution is not contaminated Zero level adjustment When pressed this key adjusts the internal calibration level of the instrument This function must always be preceded by the Check function The calibration setting is completed when the message New adjustment is done appears on the screen Perform a new check Perform at least two more checks If the check still fails it may be necessary to perform adjust of the instrument this is done by pressing the key marked Adjust N I NNN T iN il Hl il NA VIN I VI T Hill HA All OVE LE LL Jli 1 L I il I M H je La KU KOF EM PICTURE 23 Check 24 Document
23. ccurate results For the reduction of such effects rapid freezing is recommended and repeated freeze thaw cycles of milk samples should be avoided Note that the instrument has two different calibrations unprocessed milk fresh milk and homogenized milk frozen milk which has been thawed and homogenized for analysis which should be used accordingly Human Milk Analysis with the HMA When performing a measurement or check it is very important to leave the syringe on the inlet for the entire procedure Leave some of the fluid in the syringe to avoid introduction of air into the cuvette as this may lead to false results Document name Document number ld M TE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Reguired Consumables eMIRIS CLEAN solution Dilute 1 tube 10 ml with 490 ml distilled or deionized water Storage room temperature DO NOT FREEZE Best before 1 year unopened tube use dilution within 3 months eMIRIS ZERO CHECK solution Dilute 1 tube 10 ml with 90 ml distilled or deionized water Storage refrigerator 4 8 C Best before 1 year unopened tube use dilution within 3 months Startup Procedure e Always make sure to start with a cleaned instrument Press the ANALYSIS button eChoose the correct calibration for either fresh unprocessed or thawed homogenized human milk For the preparation of
24. cedure is required For the HMA analysis the milk should be collected instantly in for instance 10 ml test tubes as it is still warm to ensure homogeneity For a duplicate measurement at least 5 ml are required The container with the human milk should be gently swirled and inspected that no fat is stuck to the walls before the transfer Any extra manipulation should be avoided e g multiple tube to tube transfers When the milk is not analyzed within the next 30 min it should be stored in a refrigerator for max 24 h or immediately frozen at a minimum of 20 C ideally 80 C to preserve the overall quality Heat the milk in a water bath to approximately 40 C before analysis and gently swirl the container or tube This step is important to achieve a homogeneous milk sample The HMA will also operate at 40 C Frozen Milk MIRIS recommends an ultrasound homogenizer MIRIS Sonicator for milk that has been stored frozen and is thawed for analysis in order to obtain optimal results Casein micelle aggregation and or fat separation oiling off can occur upon thawing This can be due to a slow freezing process or long storage time age gelation of the milk As this renders representative sampling difficult such milk should be homogenized for improved repeatability and accuracy Actually this is a general problem and independent of the analytical method used Casein micelle aggregates can cause blockage or air in the measuring unit yielding ina
25. cument number shal NETS User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA What do do if the instrument hangs no response when pressing the buttons or using the mouse Turn of the instrument and restart it again If have closed the application software how do start it again Restart the instrument by pressing the on off button Or open the software this action requires a mouse Follow the instructions below see picture 93 95 1 Open My Device PICTURE 93 Start screen open My Device 2 Open BIN PICTURE 94 Open BIN 3 Scroll down and open Miris2005 Note that you have to open the icon shown in picture 93 PICTURE 95 Miris2005 the application software 50 Document name Document number M ES User Manual HMA Prepared by Approved by Date Program Produt Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 12 WORKING PRINCIPLE OF THE INSTRUMENT PRINCIPLE OF OPERATION This instrument is based on mid infrared spectroscopy It is developed for the analysis of liquids Although the instrument has a built in temperature regulator always pre warm the samples to 40 C 104 F in order to get optimum sample quality Sample is injected into the instrument Thermal re i Sample temperature is adjusted automatically egulation Sample is analyzed with infrared spectrosc
26. e Human Milk Analyzer HMA is an analytical instrument for the direct determination of the nutritional content fat protein and carbohydrates of human milk MIRIS AB can only guarantee the performance of the instrument if the instructions are followed carefully eThe HMA is intended for non diluted breast milk without any chemical additives except for the preservative Bronopol If the purpose is to analyze diluted milk a special calibration is required elt is not intended to measure the nutritional content of any other liquid for example fortified human milk or infant formula This is due to that fortifiers and instant formulas use hydrolyzed proteins and this will lead to wrong results HMA Instrument The HMA is based on mid infrared transmission spectroscopy which consists of an emitter cuvette and detector The transmission values are converted to concentrations by different calibration models The calibration models are predicted from pure breast milk samples with known concentrations The HMA is calibrated against standard reference methods already established and used in the dairy industries These reference methods are ISO certified and IDF recommended R se Gottlieb for fat Kjeldahl for total protein or true protein True protein measurement equals crude protein minus non protein nitrogen NPN The reference method for carbohydrate lactose and oligosaccharides content is calculated from the difference between total solids minus
27. eyboe 4 Jon LEH i pe eens i 90400040 m etter She eteced i 7 peeeeeee ses i i PICTURE 84 Working on update 47 BIAS 3 Document name Document number MENS User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA When slope bias is unmarked the instrument is set to change the bias settings see picture 86 This will also read in the left upper corner of the screen see picture 87 ll t L hi PICTURE 86 Bias is set PICTURE 87 Bias is set Change the value for each parameter by using the keyboard on the screen press on or by using an external keyboard It is possible to move the keyboard on the screen by using the mouse When done turn off the keyboard PICTURE 88 Use the on screen keyboard or an external keyboard to change the values Press update The update button will turn red and the process is done when it is grey again see pictures 89 and 90 PICTURE 89 Working on update PICTURE 90 Bias update is finished 48 Document name Document number ld M TE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 11 TROUBLESHOOTING AND PROBLEM SOLVING If any problem should occur that you are unable to solve by referring to this manual please contact your distributor or MIRIS AB When doing so p
28. fat protein and ash Total solids are measured by drying oven The HMA measures the absorbance of the fats proteins and carbohydrates and is then calibrated versus these reference methods Document name Document number NILENS User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA To avoid damaging the HMA and the optical unit eNever inject liquids outside the temperature range 15 45 C 59 113 F e Never force liquid into the system since this may break the cuvette e Never inject other liquids than milk MIRIS check MIRIS clean or de ionized distilled water into the system e Never leave a milk sample in the system for more than five minutes Storage or transport of the HMA at temperatures below 0 C 32 F must always be done with the cuvette completely empty and dry e Never open the instrument as breaking of the seal invalidates the warranty This should only be done by an authorized service engineer e Always leave the instrument filled with de ionized or distilled water when not in use and make sure the system is closed eSecure that the in and outlet ports are in place in order to avoid dirt entering the cuvette eAlways keep the protective cap on the RS232 connection when not in use eNever use any other power supply than ADAPTER ELPAC POWER SYSTEMS MODEL MWA10018A 12 Input voltage 100 240 V 50 60 Hz 2 3A Output voltage 18 V DC 100V
29. is required to be able to move the keyboard on the screen Press settings and slope bias The following screen will be shown see picture 80 NA i MK PICTURE 80 Slope bias menu 1 Choose calibration unprocessed milk 0 homogenized milk 1 SLOPE 2 When Slope Bias is marked the instrument is set to change the slope see picture 81 This will also read in the left upper corner of the screen see picture 82 PICTURE 81 Slope is set PICTURE 82 Slope is set 46 Document name Document number NIE User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Change the value for each parameter by using the keyboard on the screen press on or by using an external keyboard It is possible to move the keyboard on the screen by using the mouse When done turn off the keyboard as setting N edalzlal4151617181910 7 1e17 yiecalwleltTtly uli lolo IELI LEDER Ap e KNELTE oe O Ns NOON GUE AN Ga OD a SH ES eee SOFC TF e FSIS AAA 04 lt i ee ake ee I NN ANN NNN dr 1219 am 5 pe LL PICTURE 83 Use the on screen keyboard or an external keyboard to change the values 4 Press update The update button will turn red and the process is done when it is grey again see pictures 84 and 85 pm hA i 4440141301 452555 45 lt 28 4 vi Slope Bias K
30. lease include the serial number and program version of your instrument The serial number is printed on the label placed at the back of the HMA Program version can be found in the menu About Machine and is also recorded in the header of each page in the User Manual MESSAGES Air in the system If this message appears the sample has not been properly injected The cause may be a worn out syringe or a foamy sample gt Repeat the measurement with a new sample and or a new syringe No energy in the system If this message appears the measurement cell is blocked The cause may be an improper sample or a hardware error gt Clean the system and repeat the measurement Error In case of any error message restart the instrument with the start butten PROBLEM SOLVING Blocked fluids system If the sample injection needs higher mechanical force than normal this may be an indication of a dirty fluids system typically a dirty filter Do not force liquid through the system Clean the filter then reverse the fluid direction and rinse with MIRIS clean If the blockage still persists remove filter housing and outlet valve using the spanner provided Problems with injecting clean in the red outlet opposite fluid direction may be caused by the black stop gasket in the outlet Open the outlet and make a slit in the stop gasket by using a pair of scissors PICTURE 91 AND 92 49 Document name Do
31. loading the program for free at http www microsoft com windowsmobile en us downloads eulas eula activesync45 1033 mspx ProductID 76 Connect the HMA and computer with the USB cable In the PC The following pictures illustrate how the connection procedure will appear on the PC screen Microsoft ActiveSync I Ol x File View Tools Help Sync Stop Details Explore Options Connecting Connecting Initial screen during the connection process Information Type Status PICTURE 108 Connecting procedure xi u e 0 Set Up a Partnership Pa rt ne rs h I p mobie device ets poden partnership between them tt e tt mr ees Choose Guest partnership or NO C Yes Sally yk bpm partnership depending on the ActiveSync ke rir ere en version intormahon between my device and the computer cot ee PICTURE 109 Partnership Guest or NO Microsoft ActiveSync d JO xi a m File view Tools Help Connected Gif e B This screen indicates that the connection is Synt Stop Details Explore Options Guest established Connected Information Type Status PICTURE 110 Established connection When the instrument is connected to the computer do the following in order to obtain the logg and minilogg files In ActiveSync select File Explore Pocket PC bin depending on Active Sync version Windows might need to be o
32. mber after the unique ID If an ID is not given samples will get an index number only Open the menu Identification PICTURE 24 Identity menu There are a few different choices of how to input the ID If using a mouse or directing by the instrument keys turn on the keyboard and enter the ID Turn off the keyboard and or press OK when finished PICTURE 25 ID input by using the keyboard on the screen PICTURE 26 Name the sample An external keyboard can also be used connect it to the USB and type in the ID Press OK Using a barcode reader connect the device via USB and read the barcode Press OK PICTURE 27 Scanning with barcode reader PICTURE 28 ID input from a barcode 26 Document name Document number df NIE User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA START Pre heat the sample to 40 C mix it well do not shake homogenize if necessary and inject the sample into the instrument Inject a minimum of 1 ml human milk or up to 3 ml Leave some milk in the syringe and leave the syringe on the inlet during the analysis PICTURE 29 Leave the syringe on the inlet during measurement and check Press start The instrument will now go through a preparing step and a working step The analysis is done within one minute and the result will be presented on the screen PICTURE 30 Press
33. n LL ayin Pig h LATILE OR ari Fedden ven a r 3 pr ri Brom d hekke ar LTER TG berguii bone Deki R Da Creve ile am ar b hy Drakt a Frp a Teva Em ai E an PR F r Hore E em di emia il imi pec br Dara melet LG ER PR PICTURE 69 The results file will be found here Save the file on the computer 40 MI User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Instruction WINDOWS XP Install Active Sync by downloading the program for free at http www microsoft com windowsmobile en us downloads eulas eula activesync45 1033 mspx ProductID 76 Connect the HMA and computer with the USB cable In the PC The following pictures illustrate how the connection procedure will appear on the PC screen Microsoft ActiveSync 1 lol x File View Tools Help Q Sync Stop Details Explore Options Connecting Information Type Status PICTURE 70 Connecting procedure Set Up a Partnership Belore you can synchronize r ommaton between yout moble device and this computer pou must sat up partnership between them Would you like to sat up partnership C Yes Set up parinershp so thal can syrchvoreze 3 on between my dence end ones computer device t guest co thal can copy or move information between my device and
34. nd inspected that no fat is stuck to the walls before the transfer Any extra manipulation should be avoided e g multiple tube to tube transfers When the milk is not analyzed within the next 30 min it should be stored in a refrigerator for max 24 h or immediately frozen at a minimum of 20 C ideally 80 C to preserve the overall quality Heat the milk in a water bath to approximately 40 C before analysis and gently swirl the container or tube This step is important to achieve a homogeneous milk sample The HMA will also operate at 40 C 21 Document name Document number S TTE User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 6 HUMAN MILK ANALYSIS WITH THE HMA Draw a representative sample using a 2 ml syringe taking care to avoid air When performing a measurement or check it is very important to leave the syringe on the inlet for the entire procedure Leave some of the fluid in the syringe to avoid introduction of air into the cuvette as this may lead to false results Required Consumables e MIRIS CLEAN solution Dilute 1 tube 10 ml with 490 ml distilled or deionized water Storage room temperature DO NOT FREEZE Best before 1 year unopened tube use dilution within 3 months e MIRIS ZERO CHECK solution Dilute 1 tube 10 ml with 90 ml distilled or deionized water Storage refrigerator 4 8 C Best before 1 year unope
35. ned tube use dilution within 3 months Startup Procedure e Always make sure to start with a cleaned instrument Press the ANALYSIS button eChoose the correct calibration for either fresh unprocessed or thawed homogenized human milk For the preparation of thawed milk which was prior frozen see Frozen Milk below ePerform a zero setting check see CHECK below Give the sample a unique identifier if needed e Warm the sample in a water bath to 40 C and mix carefully do not shake vigorously or vortex to avoid introduction of air bubbles elnject ca 2 ml for single measurement into the instrument leaving some milk in the syringe and the syringe on the inlet during the analysis 22 Document name Document number df VIPERS User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA ePress START eThe result is presented on the screen after approximately one minute eContinue analyzing the next sample or clean the instrument Cleaning has to be done after every 10th sample or when the instrument is not in use for more than five minutes PICTURE 22 Choose calibration 23 Document name Document number Saf NILENS User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA CHECK After cleaning the instrument always perform a check in order to ensure th
36. new passwords 6 Press OK RESETTING THE INDEX NUMBER The index number is reset to start back on one in the menu Settings by pressing Index 1 44 Document name Document number NILENS User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 10 SLOPE AND BIAS The instrument is pre calibrated against chemical reference methods at the factory but it is possible to adjust the calibration level against official and approved calibration samples used in your own country or region Under the instrument menu Settings Slope Bias there is an external calibration program giving the opportunity to adjust the calibration with slope or bias factors HMA has two calibrations unprocessed and homogenized milk When using this function note that slope and bias need to be set for each calibration separately This requires reliable reference samples with known contents and an adjusted instrument Slope is a multiplication factor adjusting the HMA readings against the official calibration samples Default value is 1 000 Bias is an additional factor adjusting the HMA readings against the official calibration samples Default value is 0 000 Method selection There are several methods to adjust the calibration of the instrument To determine the magnitude of the slope and bias error at least two reference samples with different concen
37. open Hard Disk USB memory Paste the two files 56 Document name Document number MITES User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA TRANSFER DIRECT TO COMPUTER Depending on the operative system Windows VISTA or XP there are two different procedures Make sure the correct program is installed before starting VISTA requires Mobile Center 6 1 and XP or older requires ActiveSync Instruction VISTA SYNCRONIZE For Windows Vista install Mobile Center 6 1 the software can be downloaded for free at http www microsoft com downloads details aspx Familyld 46F72DF1 E46A 4A5F A791 09F07AAA1914 amp displaylang en Connect the instrument and the computer with the USB cable using the USB B connection In the computer Windows Mobile Device Center starts automatically this may take a while be patient PICTURE 106 Initial connection screen Press Connect without setting up your device PICTURE 107 Press File Management and then Browse the contents of your device Open Bin The logg and miniloggfiles are found here Save the files on the computer 57 Document name Document number Manis User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Instruction WINDOWS XP Install Active Sync by down
38. opy Constituents are evaluated Results are presented Figure 2 Measurement process of the HMA The flowchart above figure 2 illustrates the measurement process The actual test time depends on the ambient and sample temperatures IR source Sample Waveband Detector Computer selector Figure 3 Working principle of the HMA The picture above figure 3 illustrates the working principle of the instrument The radiation from an IR source penetrates a transparent cuvette containing the liquid sample After passing through the chamber the spectral contents of the IR signal are evaluated The constituents are calculated based on the spectral contents and then presented to the user 51 Document name Document number df MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA Appendix 1 Transfer text file to Excel spread sheet Open Excel Choose open all files and open the results file Choose delimited Mark tab and comma Press finished a SNE The results will now be presented in columns in the Excel sheet The columns might need to be made wider to see all information The columns from left to right will show the following information ID och indexnummer M measurement analyse Q calibkation change Time Calibration number G H I I K l HA H Ck E ve i Fae i a LI AE Kelle GM di i 35 55 31 57
39. or the day perform filter cleaning see User Manual inject distilled or deionized water and leave the system closed A gt VF KG i i j A Ww i La NOTE If it is hard to inject the cleaning fluid in reversed direction it is most likely due to the outlet stop gasket 28 Document name Document number TT User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA INSTRUMENT SURFACE Clean the surface of the instrument using a cloth dampened with Miris Clean CLEANING THE IN AND OUTLET It is very important to make sure that the instrument s in and outlets are clean MIRIS AB recommends frequent cleaning depending on the number of analyses per day and how often the instrument is used For normal use the guideline is to clean at least the filter number 5 and the entire in and outlets once a week Use MIRIS CLEAN and a small brush e g a tooth brush Procedure 1 Usethe small spanner provided to unscrew the inlet from the instrument 2 Open the inlet and outlet and separate all parts 3 Clean with MIRIS clean and rinse with water The filter is the most important part to clean 4 Mount the parts again and re screw the in or outlet NOTE Never use the spanner to re screw the in and outlet do it by hand Otherwise the instrument might get damaged PICTURE 37 Loosen the inlet by
40. pened Copy the files and save them on the computer 58
41. roved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Press change PICTURE 100 After change has been pressed the following screen will appear Type in the old password and type in No shift sensitive as new password PICTURE 101 Old and new passwords typed in Press OK The initial screen will appear Follow steps 1 3 and log in with the password No Restart the instrument with the on off button When the instrument starts up no log in is necessary and the instrument will be in administrator mode It is still possible to change to guest or operator but in such case password is needed to change between the users in the menu user Remember that when changing back to Administrator in this menu the password No is needed 55 Document name Document number df NIE User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Appendix 4 Retrieving the minilogg and logg files easiest using an USB hub in order to obtain the files without connecting the instrument to a computer USB HUB 1 Connect a USB hub with a mouse and a USB memory stick to the instrument 2 Press exit PICTURE 102 3 Open My Device PICTURE 103 4 Open Bin PICTURE 104 5 Copy the files named logg and minilogg PICTURE 105 6 Close bin and
42. rument is turned on Do not use any other adapter than the one received with the instrument It has a plug designed for HMA PICTURE 8 Plug 2 Pull back the black plastic cover 15 Document name Document number df NIE User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA 3 Keep the cover pulled back while inserting the plug with the flat side down PI CTURE 11 and 12 Keep the cover pulled back and insert the plug 4 Done PICTURE 13 Correctly attached power plug Place a tube on the outlet red Before first time use the fluids system must be rinsed with at least 15 ml MIRIS Clean see instructions page 9 16 Document name Document number Mg THES User Manual HMA Prepared by Approved by Date Program Product 4 Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 2 LOG IN optional The software is designed to have the opportunity to log in with a username and password There are three levels of operating the instrument GUEST access to change ID perform an analysis by pressing start look at machine and contact OPERATOR access to all functions available as guest plus switching between the calibrations transferring results viewing the results and performing check and adjust ADMIN all functions of the instrument available This screen will be shown when starting
43. ssing left right up down Click by pressing click Press finished when done with the settings 42 Document name Document number M MIEIS User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA HOW TO CHANGE PASSWORDS optional To change the password open the menu About and press User 1 Mark the box Admin Operator or Guest depending on which password to change Admin WAT TT vaat kalp KN i PICTURE 75 Admin 2 Turn the keyboard on 4 17 ty ie be wul a if bl ziy GENER di l ithr i t satdan t iat t pungen A f N 5 Ctl aul i eN g l i HN rea Hitt ted 3 Type in the password and turn off the keyboard TAN TAMAMEN 11213 H i HELLE e SN f l Tigi HERE Y d AO ee EN 2 vu JIA i f af Low F he j i h me vw te TE PICTURE 77 and 78 Describing the screen when typing in the password 43 Document name Document number M KATE User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA 4 Press change FE 5 2 3 i 3 LI EMMA wrt et PICTURE 79 Initial screen after change has been pressed 5 Type in the old password and a new password retype the new password PICTURE 80 Old and
44. tered without written approval of MIRIS AB Miris will not be held responsible for the analysis result of an altered machine nor will the user be allowed to mentioned Miris in combination with any results obtained from an altered machine e MIRIS should be notified within 48 hours if any injury occurs in any association with the Human Milk Analyzer and will be allowed prompt and thorough examination of the Human Milk Analyzer in question e MIRIS will not be held responsible in cases of injury arising a Beyond working life normally 7 years of the Human Milk Analyzer b When Miris is not used according to the instructions in this manual c When MIRIS is not notified within 5 days of said injury d From interpretation of results or from any treatment based on the results 10 Document name Document number NILENS User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA IMPORTANT SAFETY INFORMATION Please read this information before installing or using the instrument e To avoid damaging the optical unit never inject liquids outside the temperature range 15 45 C 59 113 F e Never force liquid into the system e Never inject other liquids than fresh milk MIRIS check MIRIS clean or de ionized distilled water into the system e Never leave milk in the system for more than five minutes e Storage or transport of the HMA at temperatures below
45. ths computer met PICTURE 71 Partnership Guest or NO Microsoft ActiveSync E JC x File View Tools Help GJERE B Stop Details Explore Options Guest Connected Information Type Status PICTURE 72 Established connection Connecting Initial screen during the connection process Partnership Choose Guest partnership or NO partnership depending on ActiveSync version Connected This screen indicates that the connection is established When the instrument is connected to the PC do the following in order to obtain the results file logg txt In ActiveSync select File Explore Pocket PC depending on Active Sync version Windows might need to be opened Copy the file named logg and save it on the computer 41 Document name Document number Av MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 9 SETTINGS This chapter describes how to change date and time passwords and how to reset the index number Changing instruments settings is easier using a USB connected mouse PICTURE 73 Settings menu HOW TO CHANGE DATE AND TIME Press Settings and DateTime PICTURE 74 Date time menu Set the correct date and time by clicking on the month day and clock Use a mouse or direct the pointer by pre
46. together with calibration name will always be present at the top of the screen See figure 1 for a schematic drawing of the instrument s menu system NOTE If you press Exit the licensed application software will close MIRIS AB is not responsible for actions done outside the application software To restart turn the instrument off and on ae Ea e EE ME EE PE EG B EK tin Ims Figure 1 Menu system of the instrument schematic Document number Wis User Manual HMA Prepared by Approved by Date Program Sofia Olsson Tony Malmstr m 2012 12 10 10 02 001 3 5 HMA Chapter 5 MILK COLLECTION AND HANDLING Before starting an analysis it is important to ensure good routines regarding milk collection handling sampling for analysis and in the case of milk which was frozen prior to the analysis homogenization Milk collection for analysis should be performed under standardized conditions e g 24h collection one complete breast sample or fore hind milk sample If local guidelines exist they should be followed If the intention is to use the HMA in a clinical research setting a clinical study protocol defining the milk collection procedure is required For the HMA analysis the milk should be aliquoted instantly in for instance 10 ml test tubes as it is still warm to ensure homogeneity For a duplicate measurement at least 5 ml are required The container where the human milk is in is gently swirled a
47. trations of each component are needed Slope and bias error measurement and calculation Analyze each reference samples with the HMA at least twice Use the average result for HMA Fatyma Proteinuma etc and for reference methods Fat r Protein etc The calibration adjustment in HMA can be done with three different methods Bias Slope or Bias and slope We recommend using the slope method SLOPE method The new slope is calculated according to New Slopez Reference HMA biasgefault TSIOPE default Example 1 New Slope 4 0 4 2 0 0000 1 000 0 9524 0 000 1 000 0 9524 Example 2 New Slope 4 0 4 2 0 1000 1 050 0 9524 0 100 1 050 0 9524 1 000 BIAS method The new bias is calculated according to New bias Biasgefaut HMA Reference Example 1 New bias 0 000 4 2 4 0 0 2 Example 2 New bias 0 100 4 2 4 0 0 1 With skills in statistics and regression analysis it is possible to make a slope and bias adjustment 45 Document name Document number M MITES User Manual HMA Prepared by Approved by Date Program Product Sofia Olsson Tony Malmstrom 2012 12 10 10 02 001 3 5 HMA HOW TO CHANGE SLOPE AND OR BIAS IN THE INSTRUMENT Before changing slope and bias please read all information to make sure what method to use and how to calculate This section will only describe how to make the settings in the instrument When doing these settings a mouse
48. u for selecting the MIRIS HMA Human Milk Analyzer Please read this manual carefully before starting to use the instrument Miris believes that breast milk is the best food a baby could receive That is why Miris promotes the use of the MIRIS Human Milk Analyzer by health professionals to help them together with moms to offer preterm born babies the nutrition they need Miris is not liable for technical failures or inaccuracies of the results resulting from misusage of MIRIS devices The use of MIRIS devices and the decisions on the measures to be taken based upon the results obtained with these must be determined by a healthcare professional Miris is not liable for the measures taken by the healthcare professional nor the results of these measures A mid infrared instrument for rapid accurate and affordable human milk analysis With the MIRIS HMA it is possible to analyze the composition of human breast milk A compact robust instrument without moving parts it is easy to handle with a broad application area The analytical technique used in MIRIS HMA is a combination of the established mid infrared transmission spectroscopy principles and a unique patent pending innovation The analytical accuracy of the instrument is compatible with other Mid IR technologies and several milk components are analyzed simultaneously in one single run requiring a small sample volume The result is provided within one minute on the display and can easily be tr
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