Miris HMA User Manual
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Miris HMA User Manual

Human milk analyzer
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Miris HMA™
Human Milk Analyzer
USER MANUAL

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  • Page 1 English Miris HMA™ Human Milk Analyzer USER MANUAL...

  • Page 2: Preface

    98/79/EC on in vitro diagnostic medical devices © Copyright 2022 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.

  • Page 3: Table Of Contents

    The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein and carbohydrate in human milk. The Miris HMA ™ also provides calculated values for total solids and energy. These measurements in conjunction with PRECAUTIONS AND LIMITATIONS ..................6 other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants.

  • Page 4: Precautions And Limitations

    Bronopol (additive). Let the Miris HMA™ completely adjust to room temperature (20- Do not use the Miris HMA™ with fortified human milk or infant 30°C, 68-86°F) before switching the power on formula. After switching the power on, allow the system to warm up by The Miris HMA™...
  • Page 5 In order to secure proper installation of the instrument and to ensure correct function, please refer to the Installation Qualification/ Miris recommends new users of the CPG to perform a few test injections with Operational Qualification documentation (www.MirisSolutions.com). distilled water to become acquainted with the amount of pressure needed to inject liquid through the cuvette, while avoiding any diversion via the CPG valve.
  • Page 6 Calib Back distilled water (see Chapter 3, Cleaning at the end of the day). At continuous daily use, leave the Miris HMA™ constantly turned on to ment to a power source and turn on keep the system stable. Always make sure the system is closed, by leaving the syringe on the inlet or by attaching the end of the outlet the instrument by pressing the on/ tube to the inlet, see storage in Chapter 9.

  • Page 7: Chapter 2 Daily Start-Up Procedures And Human Milk Analysis

    Instrument identification The serial numbers and product numbers of the Miris HMA™ can be found on the instrument label. This information is also available in the menu ‘About’ in the application software, by pressing ‘Machine’. The installed version of the application software is also specified here, printed on line 6 ‘Application software’.
  • Page 8 Turn on the heating bath to warm up to 40°C (104°F) Prepare working solutions of Miris Check™ and Miris Cleaner™ Pour the daily requirement of working solutions of Miris Check™ and Miris Cleaner™, and of distilled water, into separate bottles to use for the day’s work This chapter describes routines for human milk sample analysis with the Miris HMA™.
  • Page 9 Open the vial and use a thermometer to check the temperature, 40°C (104° F) A8. Cleaning Clean the Miris HMA™ every 10th analysis, or if the instrument has been idle for 5 minutes with milk in the cuvette. Homogenize the sample for 12 seconds (1.5 s/ml) with the Miris Ultrasonic Processor If continuing analysing samples, Miris HMA™...

  • Page 10: Chapter 3 Cleaning Routines

    MIRIS HMA™ USER GUIDE Chapter 3 CLEANING ROUTINES CLEANING OF THE INSTRUMENT SURFACE CLEANING OF THE INSTRUMENT IN- AND OUTLET 18 | DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS Miris HMA™ User Manual Miris HMA™ User Manual CLEANING ROUTINES | 19...
  • Page 11 6. Inject 5 ml distilled/deionised water, leave about 0.5 ml in the syringe. Clean the surface of the instrument using a cloth dampened with Miris Cleaner™. Use a mild disinfectant if necessary. Keep the area around and beneath the instrument free from dust.

  • Page 12: Chapter 4 Zero-Setting And Control Procedures

    Figure 17. Figure 18. Figure 19. Figure 20. 2. Clean the CPG from any milk residues using a cloth and Miris Cleaner™. Figure 21. 3. Reassemble the Filter House Restrictor and Stop Cover House Restrictor and attach to the instrument.
  • Page 13 Ensure also that the Miris Check™ solution is not preceded by the zero-setting check procedure. Inject new Miris has altered since the factory calibration at Miris. The instrument will alert the user by displaying a warning message at the event contaminated and that the inlet filter is clean.

  • Page 14: Chapter 5 Milk Collection And Handling

    • Mix carefully and homogenize the milk with Miris Ultrasonic Processor (1.5 s/ml) COLLECTION AND SAMPLING • Analyse 10 replicates of the sample on the Miris HMA ™ , injecting 3 ml for each analysis • Clean the Miris HMA™...
  • Page 15 -20°C (-4°F) to preserve the overall quality of quality. Storage recommendations are summarised in Table 3. or bring air into the measuring unit of the Miris HMA™ and fat separation will make the sample, if it is to be kept beyond 3 days for preserved milk or representative sampling difficult.
  • Page 16 Calibration 1: Homogenized milk Defrost the milk sample if necessary. Heat the milk in a 40°C (104°F) water bath. Homogenize the sample 1.5 s/ml using Miris Ultrasonic Processor. Gently swirl the container or tube to ensure homogeneity and check no fat is stuck to the container walls. No shaking in order to avoid foaming.

  • Page 17: Chapter 6 Result Review

    MIRIS HMA™ USER GUIDE Chapter 6 RESULT REVIEW VIEW LAST RESULTS TRANSFER THE RESULTS DATA INTERPRETATION 32 | MILK COLLECTION AND HANDLING Miris HMA™ User Manual Miris HMA™ User Manual RESULT REVIEW | 33...
  • Page 18 Cancel DATA INTERPRETATION VIEW LAST RESULTS Miris recommends the use of Microsoft Excel to process data for In the menu ‘View’ it is possible to see the results from previous i.e. repeatability test or replicate samples control. Since the result Result Viewer measurements.

  • Page 19: Chapter 7 Settings

    MIRIS HMA™ USER GUIDE Chapter 7 SETTINGS CHANGE DATE AND TIME RESET THE INDEX NUMBER IDENTITY OF SAMPLE LOG-IN CHANGE USER LEVEL 36 | RESULT REVIEW Miris HMA™ User Manual Miris HMA™ User Manual SETTINGS | 37...
  • Page 20 About Got adjustment parameters Login Under ‘Settings’ press ‘Login’ to open the login screen, see Load calibration 1 parameters from file figure 27. Analysis – HMA HOMOGENIZED MILK (1) Sytem loaded Click the desired rights-box Index 0002 39.99°C Turn the on-screen keyboard on...

  • Page 21: Chapter 8 Consumables And Spare Parts

    MIRIS HMA™ USER GUIDE Chapter 8 CONSUMABLES AND SPARE PARTS MIRIS CLEANER™ MIRIS CHECK™ MIRIS CALIBRATION CONTROL KIT™ DISTILLED OR DEIONISED WATER SYRINGES SAMPLE TUBES SPARE PARTS 40 | SETTINGS Miris HMA™ User Manual Miris HMA™ User Manual CONSUMABLES AND SPARE PARTS | 41...
  • Page 22 Control material for Miris HMA ™ . Includes standardised solutions in two concentrations, Miris Calibration Control ™ 1 and Miris Calibration Control ™ 2. Application: Only for quality control of the preset internal calibration of Miris HMA ™ . The device is intended for use in Materials provided: Materials required but not provided: laboratories by laboratory personnel.

  • Page 23: Chapter 9 Storage And Transportation

    DISTILLED OR DEIONISED WATER (NOT PROVIDED BY THE MANUFACTURER) MIRIS HMA™ USER GUIDE Distilled or deionised water is required to dilute concentrates of Miris Check™ and Miris Cleaner™ to working solutions, and for stand-by and storage of the Miris HMA™.

  • Page 24: Chapter 10 Troubleshooting And Problem Solving

    At long-time storage, inject 2 x 5 ml of fresh distilled/deionised water minimum every second week. Pay attention to the temperature of the distilled/deionised water injected depending on if the Miris HMA™ is switched on or off: • If the instrument is turned on the temperature of injected liquids must be 35-40°C (95-104°F) •...
  • Page 25 Blocked fluids If the sample injection Do not force liquid through the system! Remove filter housing at the back of the Miris HMA™. Software version can be found in Problem system needs higher mechanical Clean the filter, then reverse the fluid and outlet valve using the menu ‘About’, ‘Machine’.
  • Page 26 Q. What routines should my milk bank use? Q. How do I know if my results are reasonable? A. Miris can only be of help setting up routines for proper use of the A. Apply Miris quality control procedures to ensure that the ™...

  • Page 27: Chapter 11 Human Milk Composition

    MIRIS HMA™ USER GUIDE Chapter 11 HUMAN MILK COMPOSITION 52 | TROUBLESHOOTING AND PROBLEM SOLVING Miris HMA™ User Manual Miris HMA™ User Manual HUMAN MILK COMPOSITION | 53...
  • Page 28 See the original article for full inclusion Miris uses the factor 6.38 to convert N content to protein content criteria. and the factor 0.8 to estimate true protein from crude protein.

  • Page 29: 56 | About Miris Hma

    20-80% not condensed Altitude Max operational altitude 2000 m Ambient air pressure 600 - 1100 mbar Pollution degree of intended Pollution degree 2 environment 56 | ABOUT MIRIS HMA™ Miris HMA™ User Manual Miris HMA™ User Manual ABOUT MIRIS HMA™ | 57...

  • Page 30: Performance Characteristics

    Table 11. Performance characteristics of the Miris HMA™. Contact Miris for more information. This section contains summaries of performance studies on Miris HMA™, by standard methods of the CLSI (Clinical and Laboratory Standards Institute) and ISO (International Organization for Standardization).
  • Page 31 Summary of results in the Miris HMA™ precision study. Repeatability and reproducibility estimated per site (A, B, C) as coefficient of variation (CV) and standard deviation (SD). Objective Compare the Miris HMA™ analysis to analysis by chemical standard methods, by estimating the bias Within-run variation, Repeatability Total variation, Reproducibility...
  • Page 32 0.0 (-0.3 - 0.3) g/100 mL at 1.5 g/100 mL; 0.1 (-0.3 - 0.6) g/100 mL at 2.5 g/100 mL • A dilution series in 8 samples was used for evaluation of the HMA fat variable (0.3, 0.4, 0.6, 0.9, 1.4, 2.5, 3.7, 4.8 g/100 mL); True protein: -0.1 (-0.3 - 0.1) g/100 mL at 0.8 g/100 mL;...
  • Page 33 (LoD) and limit of quantitation (LoQ), for analyzing fat, crude protein, true protein, and carbohydrate carbohydrate content in a normal human milk sample using the Miris HMA™, following the CLSI EP07-A2 standard [14]. The calculated in a human milk sample, according to the CLSI EP17-A2 standard [13]. The calculated parameters parameters total solids and energy were also evaluated.
  • Page 34 Test level expected Test level high Unit Interference detected Study design Acetaminophen mg/L By running samples of milk and water, or milk and Miris Cleaner™, through the Miris HMA™, the carry-over effect Ibruprofen 1200 µg/L was assessed. Analgesics Oxycodone µg/L...

  • Page 35: Working Principles Of The Instrument

    Figure 33. Working principle of the Miris HMA™. Figure 33 illustrates the working principle of the instrument. samples are analysed both by the Miris HMA™ and by a standard The radiation from an IR-source penetrates the transparent method. The Miris HMA™ results and the standard method cuvette containing the liquid sample.
  • Page 36 Table 12. Description of components in human milk analysed by Miris HMA™. REFERENCES Component Reportable unit Definition Mid-IR absorbance Standard method [1] ISO, “1211:2010 Milk - Determination of fat content - Gravimetric method (reference method),” International Organization for Stand- Chemical bond λ...

  • Page 37: Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic immunity The Miris HMA™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Miris HMA™ should assure that it is used in such an environment. Immunity test...
  • Page 38 Recommended separation distances between portable and mobile RF communications equipment and the Miris HMA™ The Miris HMA™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Miris HMA™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Miris HMA™...
  • Page 39 www.MirisSolutions.com...

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