Miris HMA User manual

Miris HMA™
Human Milk Analyzer
USER MANUAL
English

Miris HMA™ User Manual | 3
READ THE MANUAL BEFORE USING THE INSTRUMENT
PREFACE
Thank you for choosing the Miris HMA™ - Human Milk Analyzer.
Please read this manual carefully before starting to use the
instrument.
Miris is not liable for technical failures or inaccuracies resulting
from misuse 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.
The Miris HMATM quantitatively measures the concentration of
fat, carbohydrate and protein in human milk. The Miris HMATM
also provides calculated values for total solids and energy. It is a
compact, robust instrument without moving parts. The analytical
technique used in Miris HMATM is a combination of established
mid-infrared (mid-IR) transmission spectroscopy principles and a
patented innovation.
name
ID
revision
issue date
article number
name
article number
software version
standard
address
web
e-mail
telephone
Miris HMA™ User Manual
DOC-511
2
2022-01-25
36-03-134
Miris HMA™
08-02-107
3
European Commission Directive
98/79/EC on in vitro diagnostic
medical devices
MIRIS AB
Danmarksgatan 26
753 23 Uppsala
Sweden
www.MirisSolutions.com
[email protected]
[phone]
Document information
Product information
Manufacturer contact information
© 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.

4 | Miris HMA™ User Manual Miris HMA™ User Manual | 5
TABLE OF CONTENTS
PREFACE.......................................................................................................................................... 3
TABLE OF CONTENT....................................................................................................................... 4
IMPORTANT USER INFORMATION ............................................................................................... 5
INTENDED USE OF THE MIRIS HUMAN MILK ANALYZER..................................................... 5
WARRANTIES AND DUTIES ..................................................................................................... 5
PRECAUTIONS AND LIMITATIONS.......................................................................................... 6
SAFETY INFORMATION ........................................................................................................... 6
MIRIS HMA™ USER GUIDE ............................................................................................................. 7
Chapter 1 INSTALLATION AND OPERATION .......................................................................... 7
Chapter 2 DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS .......................... 13
Chapter 3 CLEANING ROUTINES............................................................................................. 19
Chapter 4 ZERO-SETTING AND CONTROL PROCEDURES..................................................... 23
Chapter 5 MILK COLLECTION AND HANDLING ..................................................................... 27
Chapter 6 RESULT REVIEW ...................................................................................................... 33
Chapter 7 SETTINGS ................................................................................................................ 37
Chapter 8 CONSUMABLES AND SPARE PARTS ..................................................................... 41
Chapter 9 STORAGE AND TRANSPORTATION ....................................................................... 45
Chapter 10 TROUBLESHOOTING AND PROBLEM SOLVING.................................................. 47
Chapter 11 HUMAN MILK COMPOSITION.............................................................................. 53
ABOUT MIRIS HMA™...................................................................................................................... 56
TECHNICAL SPECIFICATIONS................................................................................................. 57
PERFORMANCE CHARACTERISTICS...................................................................................... 58
SUMMARY OF BENCH TESTING ............................................................................................ 59
WORKING PRINCIPLES OF THE INSTRUMENT ...................................................................... 68
MANUFACTURER’S DECLARATION......................................................................................... 72
IMPORTANT USER INFORMATION
To operate the instrument, the user must be trained by MIRIS or a MIRIS authorised distributor.
WARRANTIES AND DUTIES
By operating this Miris HMA™ the USER and MIRIS agree to the following responsibilities,
which constitute contractual warranties and conditions between MIRIS and USER for the
maximum benet and usefulness of the Miris HMA™.
MIRIS AB WARRANTS THAT IT:
• Knows of no defects in the construction of the Miris HMA™ or its materials used
• Will replace or repair the Miris HMA™ according to the guarantee in the product
warranty
USER WARRANTS THAT:
• The Miris HMA™ will be used according to the instructions given in the user manual
• The Miris HMA™ will not be altered without written approval of MIRIS AB. Miris will not
be held responsible for the analytical results from an altered machine, nor will the user
be allowed to mention Miris in combination with any results obtained from an altered
machine
• MIRIS should be notied immediately if any injury occurs in any association with the
Miris HMA™, and will be allowed prompt and thorough examination of the Miris HMA™
in question
• MIRIS will not be held responsible in cases of injury arising from use of the Miris HMA™:
a. When the Miris HMA™ is not used according to the instructions in
this manual
b. When Miris is not notied within 5 days of said injury
INTENDED USE OF THE MIRIS HUMAN MILK ANALYZER
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
other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants.
This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.

6 | Miris HMA™ User Manual Miris HMA™ User Manual INSTALLATION AND OPERATION | 7
SAFETY INFORMATION
To avoid damaging the Miris HMA™ and the optical unit (cuvette),
please read this information before installing or using the instru-
ment.
Let the Miris HMA™ completely adjust to room temperature (20-
30°C, 68-86°F) before switching the power on
After switching the power on, allow the system to warm up by
waiting 30 minutes before proceeding
When the instrument is switched on, never inject any liquids
outside the temperature range 35-40°C (95-104°F)
Never force liquid into the system
Never inject other liquids than milk, Miris consumables or deion-
ised or distilled water into the system
Never leave milk idle in the system for more than ve minutes
Storage or transport of the Miris HMA™ at temperatures below
0°C (32°F) must always be done with the cuvette completely
empty of any liquid
Never open the instrument, breaking of the void seal will invalidate
the product warranty
Always leave the instrument lled with deionised or distilled water
when not in use and make sure the system is closed. At long-time
storage, inject fresh distilled/deionised water minimum every
second week
Ensure that the in- and outlet are protected by protection caps or
tubing when the instrument is not in use to avoid dirt entering the
cuvette
User must ensure that accessories used with the Miris HMA™ will
not contaminate the sample or inuence the measurement results
Always leave the protective cap covering the computer connection
(RS232) when not in use
Do not use any other power supply than the one supplied by Miris,
included in the instrument starting kit
Consider using UPS (uninterruptible power supply) protection to
shield the instrument from power failures and power spikes
Please ensure to read the full User Manual in order to
secure proper handling
Please refer to the Installation Qualication/Operational
Qualication documentation (www.MirisSolutions.com) to
secure proper installation and functional control
The performance of the instrument is only guaranteed if
the instructions provided are followed carefully
MIRIS HMA™ USER GUIDE
Chapter 1 INSTALLATION AND OPERATION
THE INSTRUMENT
IN- AND OUTLETS
ELECTRICAL REQUIREMENTS
OPERATING THE INSTRUMENT
BASIC PRINCIPLES
Citalopram Results in a negative bias on fat measurements
Sertraline Results in a negative bias on fat measurements
Ampicillin Results in a negative bias on fat measurements
Vancomycin Results in a positive bias on fat measurements
Clindamycin Results in a negative bias on fat measurements
Cephalexin Results in a negative bias on fat measurements
Pseudoephedrine Results in a negative bias on fat measurements
PRECAUTIONS AND LIMITATIONS
For in vitro diagnostic use only.
Do not dilute milk samples. The only acceptable preservative that
can be used is Bronopol (additive).
Do not use the Miris HMA™ with fortied human milk or infant
formula.
The Miris HMA™ is not the sole basis for nutritional management
of the newborn, use of the Miris HMA™ device is intended as
part of an overall treatment plan and nutritional measures for
newborns. The Miris HMA™ is an aid to the healthcare providers’
standard of care assessment of nutritional management of new-
borns through monitoring of weight gain and growth.
Clinicians should follow clinical practice guidelines and standard
of care when supplementing or fortifying human milk.
Do not analyze milk that may contain any of the drugs listed
below, i.e. milk from mothers taking the drug:
Human milk may be contaminated with hemoglobin, from whole
blood. This will result in a positive bias on protein measurements.
If the milk is visibly pink, presumed from blood contamination,
macronutrient analysis by Miris HMA™ is not recommended.
For further information on the interference testing, see section
Summary of Bench Testing.
INTERFERENCE STATEMENT

8 | INSTALLATION AND OPERATION Miris HMA™ User Manual Miris HMA™ User Manual INSTALLATION AND OPERATION | 9
In order to secure proper installation of the instrument and to
ensure correct function, please refer to the Installation Qualication/
Operational Qualication documentation (www.MirisSolutions.com).
Figure 1. Miris HMA™ front.
Figure 2. Miris HMA™ back.
1. Display
2. Outlet
3. Inlet
4. Buttons
5. On/off button
6. Power connector
7. Reset button
8. Computer connection (OPTIONAL, RS232)
9. Computer connection (USB A)
10. INACTIVE
11. INACTIVE
THE INSTRUMENT
MIRIS HMA™ USER GUIDE
Chapter 1 INSTALLATION AND OPERATION
12
3
4
5 6 7 8 9 10 11
IN- AND OUTLETS
Inlet and outlet CPG
Figure 3.
Restrictor House
Figure 4.
Filter House Restrictor, O-ring, Inlet Filter
Figure 5.
Stop Cover House Restrictor, O-ring
Cuvette Pressure Guard (CPG)
The Cuvette Pressure Guard, CPG, protects the cuvette from being exposed to harm-
ful pressures at injection both via the blue inlet and the outlet. Fluid injected through
the CPG at pressures exceeding 3 bar, will be diverted via the valve at the side of the
CPG and will not pass through the cuvette. The CPG parts are given in Figures 3 to 5.
Miris recommends new users of the CPG to perform a few test injections with
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.

10 | INSTALLATION AND OPERATION Miris HMA™ User Manual Miris HMA™ User Manual INSTALLATION AND OPERATION | 11
Figure 7.
Figure 9.
Figure 8.
Figure 10.
Figure 6. Adapter and power cable.
ELECTRICAL REQUIREMENTS
The Miris HMA™ requires 12-20 V , 100VA.
Do not use any other power supply than the one supplied by Miris,
included in the instrument starting kit (Figure 6). Consider using
UPS (uninterruptible power supply) protection to protect the instru-
ment from power failures and power spikes.
1. Pull back the plastic cover.
2. Keep the cover pulled back while you
insert the plug. Attach the instru-
ment to a power source and turn on
the instrument by pressing the on/
off button. The licensed application
software will automatically start when
the instrument is turned on.
INSTRUMENT PLACEMENT
The Miris HMA™ should be placed in an area free from dust, dirt, explosives, corrosive fumes, and extremes of tempera-
ture and humidity (see Technical specications). Place the instrument on a stable work bench or similar. Avoid draft and
vibrations that can inuence the accuracy of results and prolong the analysis time. Never place the instrument in direct
sunlight, which may disturb the function of the instrument. Keep the area around and beneath the instrument clean and
free from dust. Always position the power supply so that it can easily be disconnected from the power grid.
Description of how to correctly insert the power plug
OPERATING THE INSTRUMENT
The start-up procedure
Follow this instruction for the rst start-up after transportation or
long time storage. The start-up procedure will take approximately
5 hours.
1. Before start-up, make sure the Miris HMA™ is completely
adjusted to room temperature (20-30°C, 68-86oF) before
switching the power on.
2. Switch the power on. The Miris HMA™ licenced application
software will start automatically and after an initial warming
period the display will read “Ready - Press a button”, see Figure
11.
3. Allow the system to warm up completely by waiting 30 min-
utes before proceeding.
4. Place the plastic tubes supplied with the instrument on the
outlet port and on the valves.
5. Inject 3 x 5 ml Miris Cleaner™ followed by 2 x 5 ml distilled or
deionized water. Make sure the temperature of the liquids is
within 35-40°C (95-104°F).
6. The instrument is now ready to use. See instructions in
Chapter 2 for instructions on milk analysis with Miris HMA™.
7. The instrument will start up in Operator user mode, see log-in
information in Chapter 7
The stand-by procedure
To leave the Miris HMA™ in stand-by mode, clean according to the instructions and nish by lling the instrument with deionised or
distilled water (see Chapter 3, Cleaning at the end of the day). At continuous daily use, leave the Miris HMA™ constantly turned on to
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
tube to the inlet, see storage in Chapter 9.
Figure 11.
Main menu.
The Miris HMA™ must only be used by personnel who has received training in using the instrument.
Analysis – HMA HOMOGENIZED MILK (1)
Settings – HMA HOMOGENIZED MILK (1)
Result – HMA HOMOGENIZED MILK (1)
Id
Filter 1 Filter 2 Filter 3 Filter 4
Change% +0.0 -0.1 +0.2 +0.2
Result [g/100ml] Fat -0.01
Crude Protein -0.03
Carbohydrates -0.01
No adjustment necessary
Start Check Adjust Calib Back
Main menu – HMA HOMOGENIZED MILK (1)
Analysis
Ready - Press a button
Load current calibration and adjustment values
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
0001 40.00°C
Index 0002 39.99°C
DateTime
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
SlopeBias Index=1 Login Back
User has operator rights 0000 39.95°C
Viewer
Calibration: HMA HOMOGENIZED MILK
Saving new adjustment parameters
New adjustment parameters saved
Transfer Tr.mini TansAll Back
You are not allowed to do this operation 0001 39.94°C
Result Settings Help About

12 | INSTALLATION AND OPERATION Miris HMA™ User Manual Miris HMA™ User Manual DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS | 13
BASIC PRINCIPLES
Instrument identication
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 specied
here, printed on line 6 ‘Application software’.
The Miris HMA™ 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 accessories at the same
time. Miris recommends using a mouse for most convenient operation of the instrument. The instrument can also, however, be operat-
ed by using the buttons to navigate the cursor. By clicking with the mouse or pressing the instrument’s buttons, operation is straightfor-
ward following the instructions on the screen. The active menu will always be presented at the top of the screen.
See Figure 12 for a schematic drawing of the instrument’s menu system.
Figure 12. Menu system of the instrument, software
version 3. *Admin log-in required.
Main menu
Analysis Result Settings Help About
ID Viewer Date/time Manual Machine
Start Transfer Slope/bias* Contact
Check Tr.mini Index=1
Adjust Trans all*
Calib
login
MIRIS HMA™ USER GUIDE
Chapter 2 DAILY START-UP PROCEDURES AND
HUMAN MILK ANALYSIS
STANDARD OPERATING PROCEDURE (SOP)

14 | DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS Miris HMA™ User Manual Miris HMA™ User Manual DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS | 15
This chapter describes routines for human milk sample analysis with the Miris HMA™.
For the rst start-up of a new instrument, refer to the start-up procedure in Chapter 1.
Follow the cleaning instructions in Chapter 3, zero-setting check procedure in Chapter 4
and the instructions for milk sample preparation in Chapter 5 accordingly.
When performing a measurement or zero-setting check it is very important to leave the
syringe on the inlet for the entire procedure, see Figure 13. Leave some of the uid in the
syringe to avoid introduction of air into the cuvette, as this may lead to inaccurate results.
For detailed instructions, go to the specic chapters referenced
in this SOP.
For further details on use and handling of Miris Ultrasonic Proces-
sor, refer to instructions in the Miris Ultrasonic Processor manual.
Notes on sample handling (further information in Chapter 5)
Control the integrity of each sample before use by checking that
specied storage temperature has been maintained and that there
are no signs of leakage or breakage of the sample container.
Defrost frozen samples at room temperature or in a refrigerator, or
in a cold water bath.
Control the sample for quality issues: e.g. the milk is churned, if a
distinct smell from free fatty acids is noticeable, if during, or after,
preparation of the sample, white particles are visible on the walls
of the sample container, fat droplets oat on the surface of the
sample. If any of these issues are noted the analysis might not be
accurate and the sample should be discarded.
STANDARD OPERATING PROCEDURE (SOP)
Figure 13.
Leave the syringe on the inlet during
the measurement.
Equipment Consumables
Miris HMA™
Ultrasonic processing device, Miris Ultrasonic Processor
Heating bath at 40°C (104°F)
Thermometer (not provided by the manufacturer)
Note! All solutions must be 35-40°C (95-104°F) when injected
into the instrument.
Miris Check™
Miris Cleaner™
Distilled/deionised water (not provided by the manufacturer)
Syringes, 2 ml and 5 ml
Waste container (not provided by the manufacturer)
Emery cloth for the ultrasonic processing device
Miris Calibration Control Kit™
Always keep sample containers securely sealed in order to avoid
evaporation, only remove the lid briey to take out samples.
Mix the milk thoroughly by gentle inversion or swirling of the
sample container. No shaking in order to avoid foaming.
If foam is formed in the sample, this needs to disintegrate com-
pletely before sample withdrawal for analysis.
A sample withdrawn by syringe must be immediately injected into
the instrument and immediately analysed.
A new sample withdrawal and injection needs to be made for each
analysis.
Avoid multiple sample container transfers.
Injection technique:
make sure liquids are injected with correct pressure. Too high
pressure (>3 bar) will divert the liquid via the valve at the side of
the CPG (see Chapter 1, in- and outlets).
Table 1. Standard Operating Procedure A
A1. Set-up Defrost frozen samples at room temperature or in a refrigerator or a cold water bath
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
Place bottles of distilled water, and working solutions of Miris Check™ and Miris Cleaner™ in the heating bath
Turn on the Miris Ultrasonic Processor and the Miris HMA™
Place a waste container by the Miris HMA™ outlet
Wait at least 30 minutes before proceeding to A2
A2. Instrument preparation Select ‘Analysis’ in the main menu
Set the Miris Ultrasonic Processor on the correct processing time (1.5 s/ml)
Control that the Miris Ultrasonic Processor probe is clean and that the tip is evenly polished
A3. Zero-setting check
Further information in Chapter 4
Watch the ‘Zero-setting check
procedure’-video at
MirisSolutions.com for details
Select ‘Analysis’ in the main menu
STEP I: Inject 3 ml Miris Check™
Press ’Check’ and wait for the result, approximately one minute
Display message “No adjustment necessary”: continue to A4
Display message “Adjustment necessary”: go to STEP II
STEP II: Inject 2 ml Miris Check™
Press ‘Check’ and wait for the result, approximately one minute
Display message “No adjustment necessary”: continue to A4
Display message “Adjustment necessary”: go to STEP III
STEP III: Press ‘Adjust’, wait for the display message “New adjustment done”
Inject 1 ml Miris Check™ Press ‘Check’ and wait for the result, approximately one minute
Display message “No adjustment necessary”: continue to A4
Display message “Adjustment necessary”: repeat STEP III
MIRIS HMA™ USER GUIDE
Chapter 2 DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS
Check
zero-level
Start up / After 10 analyses and cleaning
Start quality control procedures / continue analysis
Check
zero-level
Adjust
zero-level
Check
zero-level
TROUBLESHOOTING GUIDE
STEP I STEP II STEP III
Not ok Not ok
Not ok
Ok Ok Ok
Clean the
cuvette
Prepare new
Check solution
Clean the
inlet lter
Repeat from
STEP I
Contact Miris
Support
After rst Adjust
After second Adjust
Overview of the Miris HMATM zero-setting check procedure with troubleshooting guide. ‘Check zero-level’ includes injection of Miris CheckTM solution and starting the
Check analysis. After completing the zero-setting check procedure, run control samples before any sample analysis.

16 | DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS Miris HMA™ User Manual Miris HMA™ User Manual DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS | 17
A4. Run control samples,
calibration control
Miris recommend following federal,
state and local guidelines for testing
of quality control materials
Sample Preparation, Miris Calibration Control Kit™
1. Place one vial each of Miris Calibration Control™1 and Miris Calibration Control™2 in a heating bath
40° C (104° F) for 10-15 minutes
2. Mix the Miris Calibration Control™1 vial by 10 times gentle inversion
3. Open the vial and use a thermometer to check the temperature, 40°C (104° F)
4. Homogenize the sample for 12 seconds (1.5 s/ml) with the Miris Ultrasonic Processor
Analyse
5. Inject 3 ml sample and analyse by pressing ‘Start’
- ensure there are no air bubbles or foam in the sample
- ensure correct injection (sample not diverted via the safety valve)
6. Compare the results for fat, crude protein, true protein and carbohydrate with the reference values, see
label on Miris HMA
If the results are within the accepted range for Miris Calibration Control™1, repeat step 2-6 with Miris
Calibration Control™2
If the results are within the accepted range for Miris Calibration Control™2, continue to step 7
If quality control results do not meet the dened acceptance criteria, patient values may be suspect.
Follow the established quality control procedures.
A satisfactory level of performance is achieved when the analyte values obtained are within the
expected control intervals on label on Miris HMA™.
Follow your laboratory’s quality control procedures if the results obtained do not fall within the
acceptable limits.
If an out of range warning message appears while running Miris Calibration Control™2 this can be
ignored
If unacceptable deviation remains, contact Miris at [email protected]
7. The internal calibration is validated, the Miris HMA™can be used for analysing milk samples.
Continue to step A5 Sample preparation.
Table 1. Standard Operating Procedure A, continued.
A5. Sample preparation
See Chapter 5 for correct collection
and handling of milk samples
Place the milk sample in the heating bath and use a thermometer to check sample temperature. Keep the
sample in the heating bath for another 5-10 minutes after reaching 40°C (104°F)
Homogenise the sample with the Miris Ultrasonic Processor (1.5 s/ml)
Analyse immediately or keep the sample in the water bath until analysis, maximum another 20 minutes
A6. Analysis Select ‘Analysis’ in the main menu
If required, press ‘ID’ and enter a sample name using the internal keyboard or barcode reader, conrm by pressing
‘OK’ (see Chapter 7)
Mix the sample thoroughly, by 10 times gentle inversion
Withdraw a 3 ml sample by syringe
- ensure there are no air bubbles or foam in the sample
Immediately inject into the Miris HMA™, leaving about 0.5 ml in the
syringe and the syringe on the inlet
- ensure correct injection (sample not diverted via the safety valve)
Initiate the analysis by pressing ‘Start’
Results for fat, crude protein, true protein, carbohydrate, total solids and
energy are presented on the display after approximately one minute
Repeat the A6 steps above to do a replicate analysis (recommended)
Repeat the A6 steps above for subsequent samples
After 10 analyses, clean the Miris HMA™ (A8) followed by a zero-setting check (A3) before continuing analysing
A7. Results
Further information in Chapter 6
The most recent result will stay on the display until the next result is presented for the following analysis
To view or export results, select ‘Result’ in the main menu
Press ‘Viewer’ to view the results on the instrument display
Press ‘Transfer’ to export the results le to a USB ash drive (FAT-32 formatted) attached to the instrument
A8. Cleaning
Full instructions in Chapter 3
Clean the Miris HMA™ every 10th analysis, or if the instrument has been idle for 5 minutes with milk in the
cuvette.
If continuing analysing samples, Miris HMA™ cleaning must always be followed by a zero-setting check (A3)
Disassemble the inlet and outlet to clean the parts every 100th analysis, or once a week
After each use of the Miris Ultrasonic Processor, wipe the probe clean with a dampened cloth and polish the
probe tip with the emery cloth
A9. Stand-by mode
See Chapter 3, Chapter 1, and
Chapter 9
After cleaning at the end of the day the Miris HMA™ must be injected with distilled water
Close the system by leaving the syringe on the inlet, or by attaching the end of the outlet waste tube to the inlet
Discard any left-overs of the prepared daily requirements of Miris Check™, Miris Cleaner™, Miris Calibration
Control Kit™ and distilled water
At continuous daily use, leave the Miris HMA™ constantly turned on
At long-time storage, inject fresh distilled or deionised water minimum every second week, make sure the
system is closed
NOTE!
A warning message will appear if the measurement result is out-of-range, higher or lower than the instrument measur-
ing range, for a particular parameter (see section Performance Characteristics).
If out-of-range, the measurement result cannot be regarded as with normal accuracy
Press OK
Reject the result
Out-of-range measurement results are available in the results le, marked with an asterisk (*)
(see further information in Chapter 6)

18 | DAILY START-UP PROCEDURES AND HUMAN MILK ANALYSIS Miris HMA™ User Manual Miris HMA™ User Manual CLEANING ROUTINES | 19
MIRIS HMA™ USER GUIDE
Chapter 3 CLEANING ROUTINES
CLEANING OF THE INSTRUMENT SURFACE
CLEANING OF THE INSTRUMENT IN- AND OUTLET

20 | CLEANING ROUTINES Miris HMA™ User Manual Miris HMA™ User Manual CLEANING ROUTINES | 21
MIRIS HMA™ USER GUIDE
Chapter 3 CLEANING ROUTINES
NOTE!
All liquids must be 35-40°C (95-104°F) when injected into the instrument. Sudden temperature changes may cause
irreparable damage to the cuvette not covered by the product warranty.
The cuvette in the Miris HMA™ must be cleaned minimum every 10th analysis, or when
the instrument has been idle for 5 minutes with milk in the cuvette.
The inlet should be disassembled and cleaned once a week or every 100th analysis,
whichever comes rst. Use Miris Cleaner™ and a small brush.
After the nal analysis of the day is performed, leave the instrument lled with distilled/
deionised water.
Please note that Miris Cleaner™, Miris Check™ and distilled/deionised water must be
warmed to 35-40°C (95-104°F) before use. The cuvette is sensitive to sudden tempera-
ture changes, which may cause irreparable damage, and the cleaning efciency of Miris
Cleaner™ is improved by warm temperature.
All volumes specied in this chapter are minimum volumes, if necessary the volumes can
be increased. Figure 14 shows a cross section of a cuvette which explains the impor-
tance of a correct cleaning routine. For hygienic reasons, it is recommended to keep the
daily required volume of consumables in separate bottles, and to discard any left-overs at
the end of the day.
Figure 14. Schematic drawing of a cuvette and in-
and outlets in cross section. The cuvette compris-
es of two windows separated by a spacer (50 µm)
which needs several injections of Miris Cleaner™ to
completely rinse any milk residues.
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.
An instruction video of how to perform cleaning of the in- and outlet is available at www.MirisSolutions.com
CLEANING OF THE INSTRUMENT SURFACE
Cleaning during analysing – Minimum every 10th analysis
1. Inject 5 ml Miris Cleaner™ in the blue inlet with pressure so the uid is diverted via
the front valve on the CPG.
2. Inject 5 ml Miris Cleaner™ in the blue inlet, through the cuvette and outlet.
3. Move the waste tube from the outlet to the inlet.
4. Inject 5 ml Miris Cleaner™ in the outlet, reverse uid direction, with pressure so the
uid is diverted via the rear valve on the CPG.
5. Put the waste tube back on the outlet.
6. If further analyses are planned, perform a Check. If it is the nal analysis for the
day, follow the instructions below.
Figure 15.
Figure 16.
Cleaning at the end of the day
1. Clean the cuvette as instructed above.
2. Move the waste tube from the outlet to the inlet.
3. Inject 5 ml distilled/deionised water in the outlet, reverse uid direction, with pressure so the uid
is diverted via the rear valve on the CPG.
4. Put the waste tube back on the outlet.
5. Inject 5 ml distilled/deionised water in the blue inlet with pressure so the uid is diverted via the
front valve on the CPG.
6. Inject 5 ml distilled/deionised water, leave about 0.5 ml in the syringe.
7. Leave the instrument with the syringe on the inlet.
If needed, the instrument can now be turned off. At continuous daily use leave the instrument constantly
turned on. For longer storage periods, follow the storage instructions in Chapter 9.
CLEANING OF THE INSTRUMENT IN- AND OUTLET

22 | CLEANING ROUTINES Miris HMA™ User Manual Miris HMA™ User Manual ZERO-SETTING AND CONTROL PROCEDURES | 23
Cleaning of the CPG – Every 100th analysis or once a week
It is important to make sure that the instrument in- and outlets are clean. Clean the entire in- and
outlets minimum once a week, or every 100 milk samples, whichever comes rst.
1. Remove the Filter House Restrictor and Stop Cover House
Restrictor. Clean the parts using Miris Cleaner™ and rinse with
distilled/deionised water. Carefully remove the gasket and
lter. The lter is the most important part to clean. Use Miris
Cleaner™ and a small brush.
2. Clean the CPG from any milk residues using a cloth and Miris
Cleaner™.
3. Reassemble the Filter House Restrictor and Stop Cover House
Restrictor and attach to the instrument.
4. Put back the waste tubes and inject distilled/deionised water
as described in Cleaning at the end of the day.
Watch the ‘Cleaning procedure CPG and lters’- video on
MirisSolutions.com for further details.
Figure 19.
Figure 17.
Figure 20.
Figure 18.
Figure 21.
Figure 22.
MIRIS HMA™ USER GUIDE
Chapter 4 ZERO-SETTING AND CONTROL
PROCEDURES
GENERAL INFORMATION
ZERO-SETTING CHECK PROCEDURE WITH ZERO-LEVEL ADJUSTMENT
REPEATABILITY TEST

24 | ZERO-SETTING AND CONTROL PROCEDURES Miris HMA™ User Manual Miris HMA™ User Manual ZERO-SETTING AND CONTROL PROCEDURES | 25
MIRIS HMA™ USER GUIDE
Chapter 4 ZERO-SETTING AND CONTROL PROCEDURES
The zero-setting check procedure with zero-level adjust-
ment and the calibration control procedure are required
controls for use of the Miris HMA™. Both procedures are
described step-by-step in the Standard Operating Proce-
dure (SOP) in Chapter 2 and are implemented in the Miris
HMA™ workow as described in gure 23.
The zero-setting check with zero-level adjustment (Figure
24b) is a validation of the zero-level of the internal calibra-
tion and must be performed at start-up and after cleaning
the instrument if continuing analysing samples. This
chapter provides further explanation of this function.
The calibration control, with analysis of control samples, is a validation of the instrument’s internal calibration and must be performed
at daily start-up before performing any sample analysis.
Miris recommend following federal, state and local guidelines for testing of quality control materials.
Repeatability testing as described in this chapter is recommended to be routinely implemented by the user to ensure instrument
stability.
ZERO-SETTING CHECK PROCEDURE WITH ZERO-LEVEL ADJUSTMENT
GENERAL INFORMATION
Figure 24c. Zero-setting check procedure results table.
Check
zero-level
Start up / After 10 analyses and cleaning
Start quality control procedures / continue analysis
Check
zero-level
Adjust
zero-level
Check
zero-level
Is the Cuvette
properly cleaned?
Clean the
cuvette
Is the check
solution within the
expiry date/free
from contaminants
or precipitations/
clear light blue
colour
Prepare new
solution
Has the inlet lter
been cleaned?
Clean the
lter
Repeat from
STEP I
TROUBLESHOOTING GUIDE
STEP I STEP II STEP III
Figure 24a. Overview of the Miris HMA™ zero-setting check procedure with troubleshooting guide. ‘Check zero-level’ includes injection of Miris Check™solution and starting
the check analysis. After completing the zero-setting check procedure, run control samples before any sample analysis.
Analysis – HMA HOMOGENIZED MILK (1)
Settings – HMA HOMOGENIZED MILK (1)
Result – HMA HOMOGENIZED MILK (1)
Id
Filter 1 Filter 2 Filter 3 Filter 4
Change% +0.0 -0.1 +0.2 +0.2
Result [g/100ml] Fat -0.01
Crude Protein -0.03
Carbohydrates -0.01
No adjustment necessary
Start Check Adjust Calib Back
Main menu – HMA HOMOGENIZED MILK (1)
Analysis
Ready - Press a button
Load current calibration and adjustment values
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
0001 40.00°C
Index 0002 39.99°C
DateTime
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
SlopeBias Index=1 Login Back
User has operator rights 0000 39.95°C
Viewer
Calibration: HMA HOMOGENIZED MILK
Saving new adjustment parameters
New adjustment parameters saved
Transfer Tr.mini TansAll Back
You are not allowed to do this operation 0001 39.94°C
Result Settings Help About
Not ok Not ok
No
No
Yes
Yes
Yes
No
Not ok
Ok Ok Ok
NOTE!
Be observant of the “Change%”-line. This percentage shows, for each instrument lter 1-4, how much the instrument transmission
has altered since the factory calibration at Miris. The instrument will alert the user by displaying a warning message at the event
of a transmission change of 10% or more for any one lter. If this happens, click ‘OK’ on the message, clean the instrument and try
the check procedure again. If the problem persists, stop using the instrument and contact Miris ([email protected]) or
your local distributor for an instrument check-up.
Inject 3 ml
MirisCheck
press ‘Check’ ‘No adjustment
necessary’
‘No adjustment
necessary’
‘No adjustment
necessary’
Ready to
analyse
Ready to
analyse
Ready to
analyse
‘Adjustment
necessary’
‘Adjustment
necessary’
‘Adjustment
necessary’
Inject 2 ml
MirisCheck
‘press ‘Adjust’
press ‘Check’
Inject 1 ml
MirisCheck
Clean the
cuvette
Prepare new
Check solution
Clean the
inlet lter
Repeat from
STEP I
Contact Miris
Support
Contact Miris
Support
press ‘Check’
STEP I
TROUBLESHOOTING
STEP II
STEP III
Figure 24b. Miris HMA™ check procedure with zero level adjustment. To be per-
formed at start-up, and after cleaning the Miris HMA™ if continuing analysing
(i.e. every 10th analysis). Select ‘Analysis’ in the main menu, begin with Step 1
and continue until message ‘No adjustment necessary’ is shown on the instru-
ment display. Watch the ‘Zero-setting check procedure’-video at MirisSolutions.
com for a visual overview.
After rst Adjust
After rst Adjust
After second Adjust
After second Adjust
Start-up
- Zero-setting check
- Calibration control
Analysis End of day
- Cleaning
- Injecting distilled water
Analyzing
≤10 analyses
Zero-setting
check
Cleaning
At start-up and after cleaning the instrument if continuing analys-
ing, i.e. every 10th analysis, always perform a zero-setting check.
This function initiates a validation of the internal calibration and
zero setting. The check procedure is described step-by-step in
Figure 24b, an overview is given in Figure 24a.
If the test fails, the text “Adjustment needed! (Repeat check twice
before adjust)” is shown. This may be an indication of a contam-
inated sample cuvette. It is then important to carefully clean the
system again. Ensure also that the Miris Check™ solution is not
contaminated and that the inlet lter is clean.
The zero-setting check procedure takes approximately one min-
ute and when the process is completed, a pass or fail message
will appear. If the check passes (“Result g/100ml” is within
±0.05), the text “No adjustment necessary” is shown and the
instrument is ready for analysis (see Figure 24c).
Zero-level adjustment
When the ‘Adjust’ key is pressed, the instrument adjusts the zero
level of the internal calibration. This function must always be
preceded by the zero-setting check procedure. Inject new Miris
Check solution and press ’Check’ again after the message “New
adjustment done” appears. The zero-setting check procedure is
completed when the message “No adjustment necessary” appears
on the screen, as in Figure 24c.
Figure 23. Miris HMA™ workow

26 | ZERO-SETTING AND CONTROL PROCEDURES Miris HMA™ User Manual Miris HMA™ User Manual MILK COLLECTION AND HANDLING | 27
REPEATABILITY TEST
Recommended as a monthly control of instrument stability.
At least 10 replicates of standard solution or a representative uniform human milk sample
are analysed.
Instructions on how to calculate standard deviation using Microsoft Excel are given in Chapter 6 Result review.
Repeatability SD should meet ≤ 0.05 g/100 ml for fat and protein, and ≤ 0.08 g/100 ml for CHO.
At deviation from the specication, it must rst be determined whether this was caused by sample factors or other external
factors. Repeat the test with a new sample, and control the environment, the instrument, and sample and instrument handling
routines. If problems persist, contact your local distributor (or Miris directly at [email protected]).
Procedure
Go through the check procedure to obtain the “No adjustment necessary” message.
• If required, enter sample ID in the menu ‘Analysis’ – ‘ID’
• Warm about 35 ml of the sample in a 40°C (104°F) water bath (20 min)
• Mix carefully and homogenize the milk with Miris Ultrasonic Processor (1.5 s/ml)
• Analyse 10 replicates of the sample on the Miris HMA™, injecting 3 ml for each analysis
• Clean the Miris HMA™
Procedure
Calculate the repeatability standard deviation (SD) on the results for fat, protein, and
carbohydrates (CHO), respectively: SD =
MIRIS HMA™ USER GUIDE
Chapter 5 MILK COLLECTION AND HANDLING
COLLECTION AND SAMPLING
STORAGE
DEFROSTING/THAWING
WARMING
ULTRASONIC HOMOGENISATION (SONICATION)
SAMPLE QUALITY
SAMPLE PRETREATMENT FOR MIRIS HMA™ ANALYSIS
SAFETY ASPECTS ON HUMAN MILK

28 | MILK COLLECTION AND HANDLING Miris HMA™ User Manual Miris HMA™ User Manual MILK COLLECTION AND HANDLING | 29
Before starting to analyse human milk samples it is important to
ensure that proper procedures are followed regarding milk collec-
tion, handling, sampling for analysis, and sample pre-treatment.
This chapter contains Miris’ recommendations for milk collection
intended for Miris HMA™ analysis, as well as references to more
information.
Milk collection for analysis should be performed under stand-
ardised conditions and the method should be chosen according
to the purpose of the analysis or study, e.g. 24h-collection, full
breast expression, fore and hind sampling, mid-feed sampling [1].
Efforts should be made to obtain a representative sample that
will reect this purpose, taking into consideration possible diurnal
variation in milk composition, longitudinal changes associated
with postpartum duration, possible seasonal effects, time since
last feed, volume of milk consumed at the prior feed, and maternal
physiological let down [1]. If local or national guidelines exist, they
should be followed (e.g. [2] [3]). For a representative sample for
nutritional analysis, 24h-collection sampling is recommended [3]
[4]. If the intention is to use the Miris HMA™ in a clinical research
setting, a clinical study protocol dening the milk collection
procedure is required.
Milk collected for analytical purposes is preferably immediately
preserved by adding Bronopol solution (20% mass/mass in
distilled water, 1 ml solution per litre of milk).
If the milk is not analysed within 2 hours of collection or thawing,
the sample should be stored in a refrigerator for a maximum of
48 h (Bronopol preserved milk 72 h). Fresh milk should be imme-
diately frozen at max -20°C (-4°F) to preserve the overall quality of
the sample, if it is to be kept beyond 3 days for preserved milk or
beyond 2 days for unpreserved milk. The freezing process should
Frozen milk should be defrosted slowly overnight in a refrigerator
(4°C, 39°F). Smaller sample volumes (<200 ml) may also be de-
frosted at room temperature (20-30°C, 68-86°F), or in a water bath
with cold water fresh from the tap. This should take about 2-3
hours for 100-200 ml.
COLLECTION AND SAMPLING
STORAGE
DEFROSTING/THAWING
If the collected milk is to be separated into smaller sample
aliquots, which is recommended as refreezing or other repeated
temperature changes of the milk should be avoided, the milk
should be warmed and mixed thoroughly prior to aliquoting in
order to ensure homogeneity. A good aliquot size purposed for
Miris HMA™ analysis is 10 ml, enough for a triplicate measure-
ment. The container with the human milk should be gently swirled
or inverted, never shaken, and inspected that no fat is stuck to
the walls before transfer to the smaller test tube or container.
Any extra manipulation should be avoided, e.g. multiple sample
container transfers.
Choice of sample container is also to be considered as fat and
protein may adhere more to some materials.
be rapid (keep milk volumes <200 ml) and the thawing process
slow. Milk that has been frozen and then thawed must not be
frozen again, as it will cause deterioration of the physicochemical
quality. Storage recommendations are summarised in Table 3.
Thawing in a microwave oven is strongly advised against because
of the uneven temperature distribution, which may cause hot-
spots and protein denaturation.
Thawed milk can be kept at room temperature (20-30°C, 68-86°F)
for a maximum of 2 hours, or refrigerated for max 48 h (unpre-
served)/max 72 h (preserved), respectively.
MIRIS HMA™ USER GUIDE
Chapter 5 MILK COLLECTION AND HANDLING
Samples should be warmed in a 40°C (104°F) water bath prior to analysis. The
entire sample should be 40°C (104°F) and the Miris HMA™ will also operate at
40°C (104°F). Never warm the milk using a microwave oven because of the uneven
temperature distribution, which may cause hot-spots and protein denaturation.
Milk is an oil-in-water emulsion and fat separation (creaming, oiling-off) and protein
aggregation are processes common in stored, particularly frozen, milk. This can be
due to a slow freezing process or long storage time (age gelation) of the milk. For
the reduction of such effects, rapid freezing is recommended and repeated freeze/
thaw cycles of milk samples should be avoided. Aggregates can cause blockage
or bring air into the measuring unit of the Miris HMA™ and fat separation will make
representative sampling difcult.
The Miris HMA™ Calibration 1 is adapted to homogenisation by Miris Ultrasonic
Processor, a high-intensity ultrasonic liquid processor, where ultrasonic waves
will generate the homogenising effect by cavitation. This method is suitable for
homogenising small sample volumes as required for the Miris HMA™. The Miris
Ultrasonic Processor has a 3 mm probe and settings optimised for human milk
(amplitude 75% full scale, no pulsation). The energy output is approximately 20 J/
sec per ml of human milk. Prior to analysis on calibration 1 on Miris HMA™, frozen
human milk should be thawed at room temperature (20-30°C, 68-86°F) or overnight at
4°C (39°F). In order to obtain high homogenisation efciency, the milk should be pre-
warmed to 40°C (104°F) and homogenised 1.5 s/ml using Miris Ultrasonic Processor.
Table 3. Milk storage recommendations [2] [3].
Sample type Location Temperature Max recommended storage duration Comment
Preserved/unpreserved
fresh/thawed milk
Room temperature max 30°C
(86°F)
2 hours
Unpreserved
fresh/thawed milk
Refrigerator max 4°C
(39°F)
48 hours Warm milk is not to be mixed with re-
frigerator-cold or frozen milk, but must
rst be chilled in a separate container
Preserved
fresh/thawed milk
Refrigerator max 4°C
(39°F)
72 hours Warm milk is not to be mixed with re-
frigerator-cold or frozen milk, but must
rst be chilled in a separate container
Unpreserved fresh milk Freezer max -20°C
(-4°F)
6 months If the milk is to be frozen, this should
be done within 24 hours of collection.
Freeze rapidly, thaw slowly. Once
thawed do not refreeze.
Preserved fresh milk Freezer max -20°C
(-4°F)
6-12 months If the milk is to be frozen, this should
be done within 24 hours of collection.
Freeze rapidly, thaw slowly. Once
thawed do not refreeze.
Any milk sample Water bath 40°C (104°F) 20 minutes after reaching 40°C (104°F)
WARMING
40°C
(104°F)
ULTRASONIC HOMOGENISATION (SONICATION)

30 | MILK COLLECTION AND HANDLING Miris HMA™ User Manual Miris HMA™ User Manual MILK COLLECTION AND HANDLING | 31
Good physical quality of the milk is essential for an accurate Miris HMA™ analysis
and the integrity of the milk sample should always be carefully controlled.
If part of the milk fat appears as oil droplets on the sample surface (oiling off), the
test sample injected into the instrument will not be representative of the fat content
of the sample. Oiled-off samples should therefore be avoided. Care should be taken
to re-incorporate cream layers sticking to the walls of containers and caps. Check
the sample for other quality issues such as e.g. the milk is churned, a distinct smell
from free fatty acids is perceptible, if during or after preparation of the test sample
white particles are visible on the walls of the sample bottle. If any of these items
are noted the Miris HMA™ analysis might not be accurate and the sample should be
discarded.
Care should be taken when handling material of human origin. All material should be handled as
potentially infectious. No test method can offer complete assurance that Hepatitis B, HCV, HIV 1 and
2 or other infectious agents are absent. Handling of samples, their use, storage and disposal should
be in accordance with local regulation and institutional biohazard safety guidelines. This also includes
handling and disposal of consumables such as syringes and tubes and re-usable parts such as waste
containers.
SAMPLE QUALITY
SAMPLE PRETREATMENT FOR MIRIS HMA™ ANALYSIS
SAFETY ASPECTS ON HUMAN MILK
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. If foam is formed in the sample, this needs to disintegrate completely before a sample is drawn for
analysis. Draw a milk sample by syringe, inject immediately into the Miris HMA™ and analyse. Always keep sample containers securely
sealed in order to avoid evaporation, only remove the lid briey to take out samples.
[1] E. Miller, M. Aiello, M. Fujita, K. Hinde, L. Milligan and E. Quinn. ”Field and laboratory methods in human milk research,” American
Journal of Human Biology, vol. 25, pp. 1–11, 2013.
[2] The Academy of Breastfeeding Medicine Protocol Committee. “Human milk storage information for home use for full-term infants”.
Breastfeeding Medicine, vol. 5, pp.127-130, 2010.
[3] Milknet. “Guidelines for use of human milk and milk handling in Sweden“, available at:
https://neo.barnlakarforeningen.se/wp-content/uploads/sites/14/2014/03/Guidelines-2017-English.pdf
[4] M. Picciano. “What constitutes a representative human milk sample?” Journal of Pediatric Gastroenterology and Nutrition, vol. 3, pp.
280-283, 1984.
REFERENCES
Oiling
off
White
particles

32 | MILK COLLECTION AND HANDLING Miris HMA™ User Manual Miris HMA™ User Manual RESULT REVIEW | 33
VIEW LAST RESULTS
TRANSFER THE RESULTS
DATA INTERPRETATION
MIRIS HMA™ USER GUIDE
Chapter 6 RESULT REVIEW

34 | RESULT REVIEW Miris HMA™ User Manual Miris HMA™ User Manual RESULT REVIEW | 35
MIRIS HMA™ USER GUIDE
Chapter 6 RESULT REVIEW
This chapter describes how results can be shown on the instru-
ment display, saved on a FAT-32 formatted USB ash drive and
exported from the instrument to a PC. The memory of the instru-
ment can save approximately 4000 measurements. When more
than 4000 analyses have been done, the system will automatically
discard the oldest data.
To take a screenshot of the result, press button 1 and 6 simulta-
neously. The buttons 2-5 will turn off momentarily to acknowledge
this. The screenshot is saved as a png-le to the USB ash drive.
Note that if no USB ash drive is connected, an error message
appears.
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’.
The rst screen shows a summary of the last actions performed
by the instrument. Number of measurements, checks, adjust-
ments and resets appear on the screen.
To view the result, choose what to be shown by marking ID, Index,
Date and Time and the Number of Samples.
To see results from measurements, press ‘M’ (marked blue in
Figure 25). The results will be presented in a table, scroll to see all
information.
Press to see performed measurements
Press to see performed zero-setting checks
Press to see performed zero-level adjustments
Not available
Press to see when the instrument has been reset
VIEW LAST RESULTS
Figure 25. Results viewer screen.
C
M
Z
SB
R
NOTE!
The result presented on the instrument display is the origin
measurement value.
Out-of-range measurement results, higher or lower than
the instrument measuring range for a particular analyte
(see section Performance Characteristics), are not
presented in the Result Viewer.
Out-of-range measurement results are presented on the
instrument display at analysis and can also be obtained after
transfer of the results, where such results are marked
with an asterisk (*).
Login
Left
Password
Rights
Keyboard:
Admin
Guest
Operator
Right Up Down Click
On Off OK
Cancel
Result Viewer
Left
ID
M C Z SB R
Right Up Down Click OK
Index Date
Id Index Date Time Calib Fat
Time
0002 11/4/2015 9:12:26 1 0.0
0003 11/4/2015 9:39:30 1 0.0
0004 11/4/2015 11:02:30 1 0.0
0005 11/4/2015 12:30:55 1 0.0
0006 11/4/2015 1:50:24 1 0.0
Number of Samples
100
TRANSFER THE RESULTS
Open the menu ‘Results’ and press ’Transfer’. Two results les will automatically be saved on the ash drive as
text les (.txt): result_datetime.txt and result_meas_datetime.txt. The latter le only contains measurements (M)
and has column headings.
Other transfer options are available: ‘Tr.mini’ and ‘TransAll’. They transfer a minilogg.txt le and the content in the
bin respectively, and are used in support matters.
For information on how to convert the text le into an Excel le, see below.
If ‘Transfer’ is pressed without a USB ash drive connected, the message “No USB memory detected” will be
shown. Connect a USB ash drive and press ‘Transfer’ again.
Results in the results les marked with an asterisk (*) indicate that at least one analyte was measured higher or
lower than the instrument measuring range (see section Performance Characteristics). Out-of-range measure-
ment results cannot be regarded as with normal accuracy and should be rejected.
Transfer the results to a USB ash drive
Connect a USB ash drive (FAT-32 formatted).
Miris recommends the use of Microsoft Excel to process data for
i.e. repeatability test or replicate samples control. Since the result
le is saved in txt-format a conversion is needed, see below.
Converting a text le to Excel format
1. Open Microsoft Excel
2. Click on the Data tab
3. In the Get External Data group, click From Text.
4. Select the text le that you want to import in the Import Text
File dialogue box.
5. Click Import
6. Select Delimited and click Next
7. Uncheck Tab and select Comma
8. Click Finished. The data is presented as in Figure 56.
Interpret results from a repeatability test
Open the result data in Excel. Enter the formula =STDEV in an
empty cell and mark the column with the parameter you wish to
interpret.
Interpret the results from a replicate samples control
Open the result data in Excel. Enter the formula =AVERAGE in an
empty cell and mark the column with the parameter you wish to
interpret.
DATA INTERPRETATION
Figure 26. The
result_meas le opened
in Excel.

36 | RESULT REVIEW Miris HMA™ User Manual Miris HMA™ User Manual SETTINGS | 37
Chapter 7 SETTINGS
CHANGE DATE AND TIME
RESET THE INDEX NUMBER
IDENTITY OF SAMPLE
LOG-IN
CHANGE USER LEVEL
MIRIS HMA™ USER GUIDE

38 | SETTINGS Miris HMA™ User Manual Miris HMA™ User Manual SETTINGS | 39
MIRIS HMA™ USER GUIDE
Chapter 7 SETTINGS
This chapter describes how to change date and time, how to reset
the index number and how to assign samples with an ID of your
choice, and how to change user log-in-levels. Changing instru-
ments settings is easier using a USB-connected mouse.
Press ‘Settings’ and ‘DateTime’. Set the correct date and time by clicking
on the month, day and clock. Use a mouse or direct the pointer using the
buttons. Press ‘Finished’ when done.
The index number is reset to 0 in the menu ‘Settings’ by pressing ‘Index=1’.
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 number after the unique ID. If an ID
is not given, samples will get an index number only.
It is recommended not to use commas (,) in ID’s, since this
complicates the data interpretation in Microsoft Excel.
Under ‘Analysis’, press ‘ID’.
CHANGE DATE AND TIME
RESET THE INDEX NUMBER
IDENTITY OF SAMPLE
LOG-IN
There are three different ways to type the ID:
• Using a mouse or direct via the instrument keys, turn on the
keyboard and enter the ID. Turn off the keyboard and press
‘OK’.
• Using an external keyboard, connect it to the instrument’s USB
port and type in the ID. Press ‘OK’.
• Using a barcode reader, connect the device to the instrument
via USB and read the barcode. Press ‘OK’.
The software has a log-in function with user ID and password.
There are three user levels giving different access to the instru-
ment’s functions. Default user is Operator. It is not possible to
change passwords. The Admin password can only be acquired
from the manufacturer.
User ID Main menu access Available functions Password (case sensitive)
GUEST Analysis
About
‘ID’ – change sample ID
‘Start’ – perform an analysis
‘Machine’ – instrument information
‘Contact’ – MIRIS or distributor contact information
Guest
OPERATOR All Access to all functions except ‘Slope/Bias’, ‘TransAll’; these
functions are NOT available
Operator
ADMIN All Access to all functions Contact Miris
[email protected]
CHANGE USER LEVEL
At initial startup, the instrument will be in Operator user mode.
1. Under ‘Settings’ press ‘Login’ to open the login screen, see
gure 27.
2. Click the desired rights-box
3. Turn the on-screen keyboard on
4. Type in the password and turn the keyboard off. The pass-
word is case sensitive.
5. Press “OK”
6. The logged-in user level is conrmed by a message at the
top of the screen, see gure 28.
Figure 27. The Log-in screen.
To check the current user level at any time, press ‘Settings’ and ‘Login’ and see which rights box is ticked.
If an action is selected that is not allowed at the current user level, a message will appear at the top of the screen (Figure 29-30)
Figure 28. The Log-in as operator successful.
Figure 29. Unauthorized action selected. Figure 30. Unauthorized action selected.
Login
Left
Password
Rights
Keyboard:
Admin
Guest
Operator
Right Up Down Click
On Off
OK
Cancel
Result Viewer
Left
ID
M C Z SB R
Right Up Down Click OK
Index Date
Id Index Date Time Calib Fat
Time
0002 11/4/2015 9:12:26 1 0.0
0003 11/4/2015 9:39:30 1 0.0
0004 11/4/2015 11:02:30 1 0.0
0005 11/4/2015 12:30:55 1 0.0
0006 11/4/2015 1:50:24 1 0.0
Number of Samples
100
Analysis – HMA HOMOGENIZED MILK (1)
Settings – HMA HOMOGENIZED MILK (1)
Result – HMA HOMOGENIZED MILK (1)
Id
Filter 1 Filter 2 Filter 3 Filter 4
Change% +0.0 -0.1 +0.2 +0.2
Result [g/100ml] Fat -0.01
Crude Protein -0.03
Carbohydrates -0.01
No adjustment necessary
Start Check Adjust Calib Back
Main menu – HMA HOMOGENIZED MILK (1)
Analysis
Ready - Press a button
Load current calibration and adjustment values
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
0001 40.00°C
Index 0002 39.99°C
DateTime
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
SlopeBias Index=1 Login Back
User has operator rights 0000 39.95°C
Viewer
Calibration: HMA HOMOGENIZED MILK
Saving new adjustment parameters
New adjustment parameters saved
Transfer Tr.mini TansAll Back
You are not allowed to do this operation 0001 39.94°C
Result Settings Help About
Analysis – HMA HOMOGENIZED MILK (1)
Settings – HMA HOMOGENIZED MILK (1)
Result – HMA HOMOGENIZED MILK (1)
Id
Filter 1 Filter 2 Filter 3 Filter 4
Change% +0.0 -0.1 +0.2 +0.2
Result [g/100ml] Fat -0.01
Crude Protein -0.03
Carbohydrates -0.01
No adjustment necessary
Start Check Adjust Calib Back
Main menu – HMA HOMOGENIZED MILK (1)
Analysis
Ready - Press a button
Load current calibration and adjustment values
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
0001 40.00°C
Index 0002 39.99°C
DateTime
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
SlopeBias Index=1 Login Back
User has operator rights 0000 39.95°C
Viewer
Calibration: HMA HOMOGENIZED MILK
Saving new adjustment parameters
New adjustment parameters saved
Transfer Tr.mini TansAll Back
You are not allowed to do this operation 0001 39.94°C
Result Settings Help About
Settings – HMA HOMOGENIZED MILK (1)
DateTime
Load current calibration and adjustment values
Load adjustment parameters from cuvette
Read adjustment parameters
Got adjustment parameters
Load calibration 1 parameters from file
Sytem loaded
SlopeBias Index=1 Login Back
Require administrative rights 0000 39.95°C