REF m-101

mLabs® ImmunoMeter
User’s Manual

For Health Care Professional Use Only

 Table of Contents
1. Introduction………………………………………………………………………..…….2
1.1 How to Use This Manual
1.2 Introduction
1.3 Specifications
1.4 Warnings, Precautions and Limitations
1.5 Symbol Descriptions

2. Installation and Configuration……………………………………….....…...…......…6

2.1 Instrument Set Up
2.2 Power up and Configure mLabs® ImmunoMeter

3. Operation……………………………………………………………………..…….....…15
3.1 Install the Data Drive
3.2 Perform Calibration
3.3 Run QC Test
3.4 Run Patient Test
3.5 Retrieve Results
3.6 Export Data to an External USB Drive

4. Maintenance………………………………………..……………………….....……..…30
4.1 Clean mLabs® ImmunoMeter
4.2 Calibrate Touch Screen

5. Troubleshooting…..………………………………..……………………….....……..…32

6. Warranty…....................................................…………….......………………………36

7. Contact Us…................................................…………….......………………………38

1
1. Introduction
1.1 How to Use This Manual

This user manual contains important information regarding the proper operation and maintenance of the
mLabs® ImmunoMeter.

The mLabs® ImmunoMeter User Manual consists of seven sections:

1. Introduction: An Overview of mLabs® ImmunoMeter
2. Installation and Configuration: Guides Through First Time Setup
3. Operation: Instructs How to Run Tests, View and Delete Results
4. Maintenance
5. Troubleshooting
6. Warranty
7. Contact Addresses and Phone Numbers

1.2 Introduction

1.2.1 The mLabs® ImmunoMeter Components

R
1 mLabs® ImmunoMeter with 1 user manual

1 power cable and power adapter

1 printer paper roll

1 calibration cartridge
Calibration Cartridge

Calibration Cartridge
R

2
 1 touch pen

1 SIM reader

1 USB Disk

1 Pipette

Optional Accessory:

1 barcode scanner

Please contact your local Micropoint distributor to obtain information about replacing the power adapter
& cable, printer paper, calibration cartridge, touch pen, or barcode scanner if necessary.

1.2.2 Diagram of mLabs® ImmunoMeter

1
Front Panel:
(1) LCD Touch Screen
(2) Warning Light 2
(3) Status Light
R

3
(4) Power Light 4
(5) Cartridge Holder
(6) Cartridge Holder Eject Button
(7) Power On/Off Button 5
6
7

3
 13

Rear Panel:
(8) Power Cable Connector
(9) RS232 Serial Port 8
(10) Ethernet Port 9
(11) SD Card Slot 10
(12) USB Ports (x2) 11
(13) Thermal Printer (inside) 12

1.3 Specifications

Display Screen 5.7” True Color Screen

Keyboard Touch Screen
I/O USB Ports ×2, Ethernet Interface ×1,
RS232 Serial Port ×1, SD Card Slot ×1
Printer Built-in 58 mm Thermal Printer
Print Paper Width: 58 mm; Outside Diameter: 50mm
OS Windows CE
Language English
Patient Records 1000 Test Results
Dimensions 296 mm x 224 mm x 268 mm (L×W×H)
Weight 3.0 Kg
Power Adapter Input: 100V~240V AC, 50Hz~60Hz
ImmunoMeter Input: 12V DC, 50VA
Environment Altitude: <2,000 m
Temperature: 10°C~35°C
Related Humidity: ≤80%
Indoor Use Only
Avoid Direct Exposure to Sunlight and Strong
Magnetic Field
Warranty Period 1 Year

4
1.4 Warnings, Precautions and Limitations

CAUTION: mLabs® ImmunoMeter is for in vitro diagnosis use only.

• Read the manual carefully prior to operation.

• Test results are intended only for applications specified in the product insert.
• Use the provided AC/DC power adapter and ensure that mLabs® ImmunoMeter is operated
within the recommended voltage.
• Immediately unplug the AC/DC power adapter if smoke is observed.
• Service for mLabs® ImmunoMeters should be performed only by Micropoint Bioscience’s service
engineers.
• The warranty will be voided if mLabs® ImmunoMeter is opened or disassembled by the user.

1.5 Symbol Descriptions

Symbol Description Symbol Description

Lot Number Expiration Date

Caution. Read Carefully. Fragile

Grounded This Side Up

Name and Address of

Avoid Liquid Spills
Manufacturer

European Authorized
Manufacture Date
Representative
Stacked No More Than 5
Hot Surface
Layers
For In Vitro Diagnostic
SN Serial Number
Use Only
PN Part Number Rev. Revision

5
2. Installation and Configuration
2.1 Instrument Set Up
• Place the mLabs® ImmunoMeter and accessories on a flat workbench.
• Do not leave the mLabs® ImmunoMeter exposed to direct sunlight or place it near an area with a
heat source or strong magnetic field.
• Please contact your local Micropoint distributor if there is any damage caused during the
shipping process.

2.1.1 Connect the power adapter to the mLabs® ImmunoMeter

• Connect the power adapter and the power cable.
• Plug the power adapter into the mLabs® ImmunoMeter.
• Plug the other end of the power cable into a power outlet.

2.1.2 Install the printer paper

• Pull and open the cover of thermal printer (Fig. 2-1) and insert printer paper according to Fig. 2-1.
• Allow a small portion of the printer paper extended outside of the printer paper compartment.
Close the cover and the printer paper will feed automatically.

Fig. 2-1
CAUTION: The thermal printing compartment may be hot during operation!
It is recommended to handle the thermal printer after it has cooled down.

2.1.3 Install the barcode scanner

• Connect the barcode scanner into the USB Port of the mLabs® ImmunoMeter.
• Follow the instructions supplied with the barcode scanner.
NOTE: This step is only available for the meter with barcode scanner.

2.2 Power Up and Configure mLabs® ImmunoMeter

2.2.1 Power up the mLabs® ImmunoMeter

• Press and hold the black “Power On/Off” button on the front of the instrument until the green
power light turns on.
• A “System Check” status shows on the screen with the status light on before the “Login” menu
displays.
6
• In the “Login Menu”, the default User ID is “Admin”, the default password is blank (Fig. 2-2).

PATIEN T TEST QC TEST

PE RO RM RETRIEVE
CALIBR ATIO N RESU LTS

SETU P INST AL L
SY STEM DATA DRIVE

USER LOGOU T
MANA GEMENT

Fig. 2-2

• The “Main Menu” will show up after clicking “LOGIN“ (Fig. 2-3).

/
i

Fig. 2-3

(Each mLabs® ImmunoMeter may have different software version and S/N number than shown.)

7
2.2.2 User Setting
• Touch “USER SETTING” on the screen as shown in Fig. 2-3. The “setup” menu will display as in
Fig. 2-4.

Fig. 2-4
The users can be deleted, modified and added.
• There are three status for the user to choose: supervisor, operator, and training user.
• There is a default supervisor USER ID - “Admin”.
• The default password for “Admin” is blank. It is suggested that the user change the password
upon logging in.
• User “Admin” can edit and delete other user’s account information.
• The supervisor can edit and delete the account information of other operators and training users.
However, only the “Admin” will be able to edit and delete other supervisors’ account information.
• The operator can not only change their own password, but also the training user’s password.
• By default, training users have no privilege to edit, delete, or affect software.
• Touch “BACK” to return to previous menu.

8
2.2.2.1 Add User ID
Click “ADD” in the “USER SETTING” menu, input user information and click “OK” to add a new
user (Fig. 2-5).

E OK

Fig. 2-5

2.2.2.2 Modify User Information

Select the user, click “MODIFY” and edit the user information. Click “OK” to save the changes
(Fig. 2-6).

E OK

Fig. 2-6

9
2.2.2.3 Delete User
Select the user to be deleted, click “DELETE” and a window will show up (Fig. 2-7). Click “Yes” to
confirm. NOTE: Only the authorized user can delete other users’ information.

Fig. 2-7
2.2.3 Configure the mLabs ImmunoMeter
®

• Click “SYSTEM SETTING” on the menu as shown in Fig. 2-3. When the “Admin” and
“Supervisor” log in, the “setup” menu will display as in Fig. 2-8.

Fig. 2-8
• The user will be able to set up the parameters for mLabs® ImmunoMeter:
The Supervisor will be able to set up all parameters. The supervisor will also determine the
authority of operators and training users. The operator and training users will only able to modify
the parameters that supervisors authorized.
• After setting up the basic parameters for the mLabs® ImmunoMeter, touch “SAVE” to save the
configuration.
10
2.2.3.1 General Settings

2.2.3.1.1 Set Print Mode

• Choose print mode by touching the open circle to either “Automatic” or “Manual” as shown in
Fig. 2-8.

2.2.3.1.2 Set Wait Mode

• Choose wait mode by touching the open circle to either “Inside” or “Outside” as shown in Fig.
2-8.

2.2.3.1.3 Set Time and Date

• Use the pull-down menu and/or up-and-down arrows as shown in Fig. 2-8 to set the date and
time.
• The time format is: HH-MM-SS (24 hours).
• The date format is: DD-MM-YYYY.

2.2.3.1.4 Set Network Configurations

• User can set up the network configurations by clicking “SETTING”. Press “CONNECT” to save
the network as shown in Fig. 2-9.

Pein t mode Automati c

wait mode Insicle

Date Time 10:26:43:AM

Netwcr k NE TW OR K

Fig. 2-9

11
2.2.3.1.5 IP Configuration
• Touch “IP CONFIG” button to enter the local connection setting. The user can either obtain an IP
address via DHCP or specify an IP address.
• If the meter is connected to the computer directly, then “Default gateway” setting can be omitted
and only the “Subnet mask” setting is necessary. The IP address of the computer and the meter
should be in the same network segment.

Fig. 2-10

2.2.3.2 QC Setting

• The user can set up the QC function by clicking “QC” tab shown in Fig. 2-11.
• If “Yes” is selected, when the cartridge of one lot fails the QC test, the general tests of the same
lot will become unavailable.
• If “No” is selected, the general tests can be performed even if the QC test fails.

Fig. 2-11

12
2.2.3.3 Calibration Setting
• User can set up the calibration setting by clicking “Calibration” tab ( Fig. 2-12).

Fig. 2-12
2.2.3.3.1 Set Frequency
• The default calibration frequency is 1 month. Use the pull-down menu as shown in Fig. 2-12 to
set the optional calibration frequency as 1 Day, 1 Week or 1 Month.

2.2.3.3.2 Set Timeout Warning

•  The default timeout warning is 10%. The warning icon will be displayed when 10% of the user
defined time period remains before calibration expires for any assays. The user can input any
number between 1 to 99 to set the timeout warning.

2.2.3.3.3 Set Max Failures Before Lockout

•  The default max failures before lockout is 10. The user can input any number between 1 to 50 to
set the max failures before lockout.

2.2.3.4 Update Instructions

• Please follow the two steps below to complete the updating process.
1. Insert the U-disk with update software into the USB port of the meter.
2. Click the “Update” button in the middle of the screen and restart the meter.

13
 Fig. 2-13

2.2.3.5 User authority setting

• The user can set up the competence by clicking “User authority setting” tab ( Fig. 2-14).

Fig. 2-14

14
3. Operation
3.1 Install the Data Drive

• Prior to running any assays, the Data Drive for that assay lot must be installed into the mLabs®
ImmunoMeter. The Data Drive provides lot-specific information such as the expiration date and
is only required to be installed once for each lot. The mLabs® ImmunoMeter can store Data
Drives from different lots. The maximum storage capacity for the meter is 150 Data Drives. As
each Cardiac Panel 3 assay contains three sub-items, the meter can only store 50 Data Drives if
all of them are for Cardiac Panel 3 assays. If the maximum is exceeded, the oldest entry will be
overwritten. A single lot-specific mLabs® Data Drive is provided along with each kit of cartridges.
Either USB disk or SIM card can be used.
• For USB disk, please insert it into the USB port at the rear of the ImmunoMeter prior to
performing a test. For SIM card, please remove the SIM card from the holder and insert it into the
SIM reader while the SIM reader is connected to the meter. Wait for 5-10 seconds for mLabs®
ImmunoMeter to recognize the Date Drive before installation.
• From the main screen of the ImmunoMeter: USB disk, press “DATA DRIVES” > “UDISK”; for SIM
card, press ”DATA DRIVES > ”SIM”.
• A screen as shown in Fig. 3-1 will display.
• Select “TEST DATA DRIVE” or “QC DATA DRIVE” according to the Data Drive type to be installed.
There is no need to install calibration Data Drive unless the user lost the calibration cartridge.
• Touch “SIM” or “UDISK“ as shown in the bottom right corner of Fig. 3-1. The Data Drive will be
installed automatically.

Fig. 3-1
• The screen displays “Please wait, installation in progress” while installing the Data Drive. After the
Data Drive is successfully installed, the screen will display “Data drive for test cartridge installed!”
Touch the upper right corner “OK” to confirm. As shown in Fig. 3-2.

15
 i

Fig. 3-2
• Remove the U-disk from mLabs ImmunoMeter after installation.
®

• Lot information will be displayed on screen after the Data Drive is successfully installed. Fig. 3-3
shows a typical display after the Data Drive is successfully installed for D-Dimer cartridge with
lot number 999998. “Lot number” represents the lot number of the cartridges and “Assay” is
the type of test cartridge. The lot manufacture date and expiration date are also shown on the
screen.

Fig. 3-3
• To delete a Data Drive, select the Data Drive you want to delete, then click “DELETE”. A window
will show up and ask the operator to confirm. The deletion will be confirmed by clicking “Yes”
(Fig. 3-4).

Note: Only supervisors, authorized operators and authorized training users can delete Data Drives.

16
 ?

Fig. 3-4
• Touch “BACK” to return to the Main Menu.

3.2 Perform Calibration

• The mLabs® ImmunoMeter will prompt the user to perform calibration tests when the
calibration is due.
• To perform a calibration, touch “PERFORM CALIBRATION” in the Main Menu. The screen, in
Fig. 3-5, will display. The user will find “Time until expiration” and “Overrides remaining” in the
screen.

Fig. 3-5

17
• Click “VIEW RESULTS” to see previous calibration data (Fig. 3-6).
• Click “CALIBRATION TEST” to perform calibration (Fig. 3-7).

Fig. 3-6

Fig. 3-7
• Press the cartridge holder eject button to eject the cartridge holder.
• Place the provided calibration cartridge with the inlet well pointing out and barcode on the right.
Touch “START” to perform calibration.
• mLabs® ImmunoMeter will perform calibration automatically. After calibration is completed,
mLabs® ImmunoMeter will display either “Calibration pass” or “Calibration fail” on the screen.
• After calibration is completed, the calibration cartridge will be ejected. Remove the calibration
cartridge from the holder and put it back to the original box. DO NOT DISPOSE OF THE
CALBRATION CARTIDGE.
• Press cartridge holder eject button to bring the cartridge holder back into mLabs® ImmunoMeter.
• If calibration fails, please contact the local Micropoint distributor for further advice.
CAUTION:
Do not add sample or control or any liquid into the calibration cartridge!
18
3.3 Run QC test

3.3.1 QC Sample and Test Cartridge Preparation

• Follow the instructions provided with QC materials to prepare liquid QC samples.
• QC liquid code and expired date will be shown on the vials label of the QC materials.
• Add liquid QC samples into cartridge according to QC material instructions.
• Place the cartridge on the cartridge holder for testing.

3.3.2 Run QC Test

• Touch “QC TEST” on the main menu screen to check the QC status.
• Select the assay item first and then touch “RUN QC TEST”.

Fig. 3-8
• The interface of “QC ranges” will appear after touching “RUN QC TEST” (Fig. 3-9). Either level 1
or level 2 can be selected to perform a test. Please fill in the low limit and high limit by referring to
the information on the vial label.

Fig. 3-9
19
 • As shown in Fig. 3-10, enter a QC liquid code (control solution number) and touch “OK”.

........
..

Fig. 3-10
NOTE: If the Data Drive for the QC lot is not installed, system will prompt as shown in Fig. 3-11(1).

(1)
Fig. 3-11

If the Data Drive for the test cartridge is not installed, system will prompt as shown in Fig. 3-11(2).

(2)
Fig. 3-11

20
 If the Data Drive for the testing cartridge is not correct, Fig. 3-11(3) will show up.

(3)
Fig. 3-11
• Insert the cartridge with QC sample into the meter and click “START”.
• mLabs® ImmunoMeter will perform QC test automatically, and display results as shown in Fig.
3-12.

Fig. 3-12
(Result shown for reference only)

3.4 Run Patient Test

• Prepare cartridge according to the package insert of the test kit.

• Load the sample into the cartridge.
• From the Main Menu, touch “PATIENT TEST”.

21
3.4.1 Select Assay Type
• Select the assay type as shown in Fig. 3-13.

•
Fig. 3-13

• The screen will display the sample type after the user selected the assay type (Fig. 3-14).

Fig. 3-14

22
3.4.2 Enter Patient ID
• Enter number (up to 15 digits) for a patient ID (Fig. 3-15). Touch “OK” to advance to the next
step.

........
..

Fig. 3-15
3.4.3 Start the Test
• mLabs® ImmunoMeter will display a test menu as in Fig. 3-16.
• Press cartridge holder eject button on mLabs® ImmunoMeter to eject cartridge holder. The
cartridge holder will be ejected.

Fig. 3-16

• Put the cartridge into the cartridge holder and touch “START” as shown in Fig. 3-16 to start the
test.

23
 • When the test is completed, the cartridge holder will eject automatically. The test results will be
displayed on the screen and saved automatically (Fig. 3-17).

Fig. 3-17
(Result shown for demonstration purposes only)

• Results will automatically be printed if mLabs® ImmunoMeter is configured for “AUTOMATIC”

printing, see section 2.2.3 Configure the mLabs® ImmunoMeter. If the printer’s mode is set to
“MANUAL”, touch “PRINT” to print the result.
• Click “SEND” to upload the test results to the server. See 2.2.3.1.4 to set up a network
connection.
• Touch “BACK” to start a new patient test.

3.4.4 About ASSAY RRS

• The “ASSAY RRS” means the reference ranges of a assay, which stands for the normal range.
• Touch “SYSTEM SETTING” on the main menu (Fig. 2-3) and the user will see “ASSAY RRS”
button.
• The “ASSAY RRS” function is disabled by default. Each assay item has both a “Min Value” and a
“Max Value” value to display the normal ranges. The user can enable the “ASSAY RRS” function
by following two steps below. If the “ASSAY RRS” function is enabled, the reference ranges
(RRS) will be displayed.
1. Select the desired assay item and then touch the “Modify” button (Fig. 3-18).

24
  
Fig. 3-18

2. A screen as shown in Fig. 3-19 will display. Check the “Enable RRs” box and the “ASSAY RRS”
will be enabled.
3. There is a default reference range and the user can modify the “Max” value.

Fig. 3-19

25
3.5 Retrieve Results

• Touch “RETRIEVE RESULTS” on the main menu. The screen will display the search options as
shown in Fig. 3-20:

Fig. 3-20
• In the “Search options” menu as shown in Fig. 3-20, users can select one or more options to
filter the results saved on the immunoMeter: (1) Result type, (2) Assay (analyze), (3) Patient ID, (4)
User ID or (5) Test date (From-Till). Results will be displayed according to search selections.
• Touch “ALL” to see all test results as shown in Fig. 3-21.
• Click “Select all” to select all data.
• Touch “PRINT SEL” to print the selected results. Click “PRINT ALL” to print all the displayed
results.
• Touch “DELETE” to delete any checked data.
• Touch “BACK” to return to the previous menu.

Fig. 3-21

26
3.6 Export Data to an External USB Drive

• Touch “RETRIEVE RESULTS” on the Main Menu. The screen will display the search options as
shown in Fig. 3-20.
• Insert an external USB drive to the rear of mLabs® ImmunoMeter.
• Touch “UPLOAD” as shown in Fig. 3-20.
• The mLabs® ImmunoMeter creates a folder named “Data#SN# YYYYMMDDHHMMSS”
in the USB drive and upload all original data and test results to the newly created
“Data#SN#YYYYMMDDHHMMSS” folder (SN will include the serial number of your
ImmunoMeter). The uploading process is shown in Fig. 3-22, with the “progress bar” indicating
the status of uploading process.
•  The “progress bar” will disappear after uploading. Do not remove the USB drive until the
uploading process is completed. If the USB drive is removed during the uploading process, the
data will be permanently lost.
• As shown in Fig. 3-22, a system prompt will pop up asking to keep the patient results during
the upload process. Select “Yes” to keep the patient results in mLabs® ImmunoMeter, or “No”
to remove all the patient results from mLabs® ImmunoMeter. Also, a system prompt will pop up
asking to keep the QC and calibration results. Select “Yes” to keep the results, or “No” to remove
all the results from mLabs® ImmunoMeter as shown in Fig. 3-23 and 3-24.
• When the upload is completed the screen will indicate data transfer completion as shown in Fig
3-23. Touch “OK” to close the window before removing the USB drive. Touch “BACK” to return to
the Main Menu.

L User ID

?
4/7/201 3 Till

Fig. 3-22

27
 .

L User ID

?
4/7/201 3 Till

Fig. 3-23

User ID
pa t.I D

?
Fr om 4/7/201 3 Till

pr ep ar e

Fig. 3-24

28
 User ID

Till

Fig. 3-25

CAUTION:
After the data is saved onto an external USB drive, the data stored in mLabs® ImmunoMeter will

be permanently removed if you select “No” as shown in Fig 3-22.

29
4. Maintenance
4.1 Cleaning the mLabs® ImmunoMeter

• Unplug mLabs® ImmunoMeter prior to cleaning.

• Clean the exterior surface and the cartridge holder of mLabs® ImmunoMeter with a lint-free wipe.
• Do not immerse mLabs® ImmunoMeter in cleaning liquid.
• Avoid spilling liquids on the mLabs® ImmunoMeter and related accessory devices.

4.2 Calibrate Touch Screen

• From the Main Menu touch “SETUP SYSTEM”, then “SCREEN SYNC”. The prompt on the screen
shows whether to continue with calibration as shown in Fig. 4-1.

Wait mode Inside Outsid e

Date
i
23/10/2014 Time 10:26:43

Connectivity IP CONFIG SETTING

Fig. 4-1
• Touch “Yes” to start calibration, and a cross cursor will be displayed on the screen.
• Touch the middle of the cursor with the provided touch pen provided until the cursor moves to the
next position. Repeat until the cursor disappears from the screen and calibration is completed. The
cursor follows the broken line shown in Fig. 4-2.

Press and briefly hold stylus on the center of the target.

repeat as the target moves around the screen.

Fig. 4-2
30
• Touch the screen according to the prompt, and the system will save the calibration parameters
automatically and return to the system setup screen, as shown in Fig. 4-3.

New calibration settings have been measured.

Click any place on the screen to save.

Fig. 4-3

31
5. Troubleshooting
Commonly encountered problems are listed below, along with probable causes and recommended
corrective actions:
General
Symptom/message
Cannot power on
Power light does not illuminate
LCD screen does not appear
LCD screen cannot be operated
or inaccurate touch location
LCD screen is hard to read (very
dim), or colors are not visible.
Stored patient results exceeded
maximum number.
Power On Self Test
Symptom/message
Unable to initialize data query
Cause(s)
Power cord is not plugged in
ImmunoMeter failure
ImmunoMeter is not plugged in
ImmunoMeter failure
Power cord is not plugged in
It takes around 1 min for screen to
appear after power on
ImmunoMeter failure
LCD screen does not respond
after powering on
Screen is not calibrated
ImmunoMeter failure
Insufficient storage space
Cause(s)
Data is already exported
System Failure
32
Action
Ensure power cord is connected
to power outlet socket and
meter
Reboot mLabs® ImmunoMeter.
If problem persists contact
technical support to report the
problem
Ensure power cord is connected
to power outlet socket and
meter
Reboot mLabs® ImmunoMeter.
If problem persists contact
technical support to report the
problem
Ensure power cord is connected
to power outlet socket and
meter
Wait for 1-2 min
Reboot mLabs® ImmunoMeter.
If problem persists contact
technical support to report the
problem
Wait for 1-2 min or reboot
mLabs® ImmunoMeter
Calibrate screen (refer to 4.2)
Contact technical support to
report the problem
Update the data to USB drive
Action
Locate the already exported data
Reboot mLabs® ImmunoMeter
Test Errors
Symptom/message
Status Light is always on
Eject Button does not work
Cartridge holder cannot be eject- movement
ed
Cartridge holder cannot be closed
Excessive noises during move-
ment of cartridge holder
Test cartridge cannot be inserted insertion
onto cartridge holder
Error message:
Please install Data Drive for test Data Drive is not installed
cartridge!
Error message:
Please enter 1-15 digit number!
Error message:
Please ensure the barcode you
inputed is right and its data drive match the entered lot number
has been installed!
Error message:
Parameters are not suitable for
this lot of cartridge!
Error message:
The authority has been
expired please install new Data
Drive!
Error message:
Test failed
Error message:
Cartridge is expired!
Cause(s)
Testing or initializing
ImmunoMeter failure
Inadequate pressure
ImmunoMeter failure
Objects are obstructing its
ImmunoMeter failure
ImmunoMeter is not sitting on a
flat surface
Objects are obstructing its
movement
Test cartridge is not inserted
correctly
Objects are obstructing its
Cartridge is not inserted properly
Input unregistered or wrong user
ID User ID or no patient ID or
patient ID is more than 15 digits
The Data Drive installed does not
Data Drive do not match the test
cartridge
Allowed number of tests have
been used up
Sample running slowly
Sample size incorrect
Improper anticoagulated samples
or body fluids
The cartridge is expired
33
Action
Wait for completion of the
process
Reboot mLabs® ImmunoMeter
Press button harder
Reboot mLabs® ImmunoMeter
Clean the obstructing objects
Reboot mLabs® ImmunoMeter
Set mLabs® ImmunoMeter on a
flat surface
Clean the obstructing objects
Reinsert the test cartridge
Remove existing objects
Adjust and reinsert cartridge
Install Data Drive (refer to 3.1)
Input correct User ID and
correct Patient ID
Install the data drive from this
lot
Contact Technical Support to
report the problem
Reinstall Data Drive. If problem
persists contact technical
support to report the problem
Possibly due to cold test
cartridges or sample, high
hematocrit with sample.
Retest sample with a new test
cartridge using adequate test
samples
Retest sample with a new test
cartridge using proper test
samples
Check the system time
Check the test card is not
expired
Data Drive Errors:
Symptom/message Cause(s)
Not enough time for mLabs
ImmunoMeter to recognize the
Data Drive
Slow or no response
Data Drive is already installed
Data Drive not found!
USB port is loose/SIM card reader operation. If problem persists
failure
Incorrect Data Drive
Error message:
Installation of this Data Drive The Data Drive has been installed
cannot be repeated!
Error message:
Data Drive is no detected in the
Data Drive not found! (USB Drive
USB Drive
version)
Error message:
Data Drive is no detected in the
Data Drive not found! (SIM card
SIM card
version)
Printer Errors:
Symptom Cause(s)
Print or automatic print is not
selected
Nothing is selected for printing
Unable to print test results
Jam
Run out of thermal printer paper
or paper is not properly installed
Poor print quality Low-quality thermal printer paper
Printer error
34
Action
Wait for about 10 sec. and
repeat operation
Reinsert Data Drive and repeat
operation
Proceed with test
Reinsert Data Drive and repeat
contact technical support to
report the problem.
Please contact with local dealer
to exchange the Data Drive
Contact technical support to
report the problem.
Check if the data drive is in
USB drive. If the data drive is
in USB drive, reboot mLabs®
ImmunoMeter. If problem
persists contact technical
support to report the problem
Reboot mLabs® ImmunoMeter.
If problem persists contact
technical support to report the
problem
Action
Refer to section 3.3 and sec-
tion 3.4
Select the items for printing
Carefully remove the paper and
print again
Reinstall thermal printer paper
Replace thermal paper
Contact technical support to
report the problem
USB Device Errors:

Symptom Cause(s) Action

Unable to upload data with USB port is loose Reinsert external USB drive
external USB device and repeat operation
External USB drive has existing Remove existing data in the
data in it external USB drive
QC & Calibration Errors:

Symptom/message Cause(s) Action

Error message: Calibration expired Run the calibration cartridge
Please run calibration test first!
QC expired QC expired Run QC sample
Error message: Data Drive is not installed Install the Data Drive
QC Data Drive is not found! Please
install first!

Error Code List:

Error Code Error Message Suggested Operation

E001 No USB disk found Check USB disk
Invalid barcode Make sure cartridge barcode keeps consistent
E002
with installed data drive
E003 Communication failure Restart meter
E004 Test interrupted Press ‘START’ to retest
E005 Invalid cartridge Retest with a new cartridge
E006 Signal error Contact technical support
E007 Light strength error Perform calibration
E008 Time error Check time setting
E009 Invalid meter setting Contact technical support
E010 Motor failure Contact technical support
E011 Abnormal sample flow Retest with a new cartridge
E012 Abnormal cartridge Retest with a new cartridge

If additional assistance is needed, please contact Micropoint Bioscience Technical Support.

Micropoint Bioscience Technical Support
TEL: +1-408-588-1682
EMAIL: techsupport@micropointbio.com
IMPORTANT NOTES: Service must be conducted only by Micropoint Bioscience’s service
engineers. The warranty will be voided if mLabs® ImmunoMeter is disassembled by the user.

**Micropoint Bioscience Inc’s (MBI) express and implied warranties (including implied warranties of
merchantability and fitness) are conditioned upon observance of MBI’s published directions with respect to
the use of MBI’s products.
35
6. Warranty
Limited Warranty

1. Use of the mLabs® ImmunoMeter. The mLabs® ImmunoMeter (the “Meter”), manufactured
by Micropoint Bioscience, Inc. (“Micropoint”), is designed only for measurement of test results
obtained using mLabs® cartridges manufactured by Micropoint. Proper adherence to the
instructions in the user manual and package inserts is critical to proper operation.

WARNING: Failure to comply with the user manual could lead to inaccurate results and resultant
incorrect diagnosis which could result in injury or death.

2. Defects Covered. Subject to the terms and conditions of this Limited Warranty, Micropoint
warrants to the original purchaser of the Meter (the “Purchaser”) that the Meter will be free from
material defects and workmanship, under normal use and service, for one year from the date of
purchase.

3. Remedy. In the event the Meter does not conform to the above warranty, then as Micropoint’s
sole responsibility and the Purchaser’s sole remedy, Micropoint will repair or replace the Meter,
at Micropoint’s option, free of charge. This warranty will apply only if the Purchaser notifies
Micropoint of the defect in writing during the warranty period, and ships the Meter back to
Micropoint at the expense of the Purchaser, along with documentation sufficient to establish
the date of purchase. Before returning a defective Meter, the Purchaser must obtain a Return
Material Authorization (“RMA”) number and return instructions from Micropoint Technical Support
by calling +1 408 588 1682.

4. Exclusions. The only user serviceable parts of the Meter are printer paper and the printer paper
door. Tampering with any other portion of the Meter, abusing the Meter, or using the Meter in a
manner inconsistent with its user manual will void this warranty. This warranty does not apply
to Meters that have been damaged during shipment, by improper storage or through accident,
Meters that have been altered or modified, or Meters that have been subject to abuse. This
warranty does not guarantee the uninterrupted operation of the Meter.

5. Warranty on Repairs and Replacements. Replacement Meters, and repairs which Micropoint
makes pursuant to the above warranty, shall carry the greater of a thirty-day warranty period or
the balance of the original warranty period.

6. No Implied or Other Express Warranties; Limitation of Liability. TO THE EXTENT ALLOWED

BY LOCAL LAW, THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES,
EXPRESSED, OR IMPLIED, BY OPERATION OF LAW, OR OTHERWISE, AND ANY OTHER
OBLIGATION ON THE PART OF MICROPOINT WITH RESPECT TO DEFECTIVE METERS,
AND MICROPOINT DISCLAIMS ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF
NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Some countries, states or provinces do not allow exclusion of implied warranties, so the above
exclusions may not apply to you.

36
TO THE EXTENT ALLOWED BY LOCAL LAW, IN NO EVENT WILL MICROPOINT BE LIABLE FOR
LOST PROFITS, BUSINESS INTERRUPTION, OR ANY OTHER INDIRECT, INCIDENTAL, SPECIAL
OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR RELATING TO THE METERS, WHETHER
UNDER A CONTRACT, WARRANTY, TORT, OR ANY OTHER LEGAL THEORY, EVEN IF MICROPOINT
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. MICROPOINT’S ENTIRE LIABILITY
IN CONNECTION WITH THE METER, REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF
ANY CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE METER. THESE DISCLAIMERS AND
LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF THESE
REMEDIES. Some countries, states or provinces do not allow the exclusion or limitation of incidental or
consequential damages, so the above limitation or exclusion may not apply to you.

This warranty gives you specific legal rights, and you may also have other rights that vary from country to
country, state to state, and province to province.

THE WARRANTY TERMS CONTAINED IN THIS STATEMENT, EXCEPT TO THE EXTENT LAWFULLY
PERMITTED, DO NOT EXCLUDE, RESTRICT, OR MODIFY AND ARE IN ADDITION TO THE
MANDATORY STATUTORY RIGHTS APPLICABLE TO THE SALE OF THIS PRODUCT TO YOU.

37
7. Contact Us
Micropoint Bioscience, Inc.
3521 Leonard Court
Santa Clara, CA 95054, USA
Tel: +1-408-588-1682
Fax: +1-408-588-1620
www. micropointbio.com

OBELIS S.A.
Bd. General Wahis, 53
1030 Brussels, Belgium
Tel: +32 2 732 59 54
Fax: + 32 2 732 60 03

Trademarks:
mLabs® and its related products, which includes test cartridge, ImmunoMeter, Data Drive, calibration
cartridge, are registered trademarks for Micropoint Bioscience Inc in the USA, and member countries of the
European Economic Community.

Patent Protection:
mLabs® and its related products, which includes test cartridge, ImmunoMeter, Data Drive, and Calibration
Cartridge are protected by pending patents.

38
 mLabs ®

Micropoint Bioscience, Inc. Obelis SA

3521 Leonard Court Bd. General Wahis, 53
Santa Clara, CA 95054 1030 Brussels
www.micropointbio.com Belgium
info@micropointbio.com www.obelis.net
Tel +1 408-588-1682 Tel +32 2 732 59 54
Fax +1 408-588-1620 Fax +32 2 732 60 03

©2015 Micropoint Bioscience, Inc. All rights reserved. Specifications are subject to change with-
out notice. mLabs® and Micropoint® are registered trademarks of Micropoint Bioscience, Inc.
P/N 630-00001 Rev. A2 .