LifeAssays Magnia Reader User manual

LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
Table of contents
1 Introduction
The purpose of this manual is to provide instructions on how to safely
and correctly use and service Magnia Reader (also “Reader” in this
document).
Here are the symbols that are used throughout this documentation:
WARNING Information presented in this box warns about
serious danger or damage to people and/or
to equipment that may also lead to unreliable
results. The instructions oer a safe way of
proceeding
CAUTION Information presented in this box warns about
possible damage to equipment and may also
lead to unreliable results. The instructions oer a
safe way of proceeding.
NOTE Information presented in this box needs to be
especially carefully considered.
2 Magnetic Immunoassay Reader
The Reader is used for analyzing the magnetic particle content in various
types of immunodiagnostic lateral ow tests. It oers superior detection
limit for particles and a wide dynamic range and sensitiveness for
measuring analytes under investigation.
The Reader supports analyzing several dierent types of test cartridges.
New types of tests can be introduced without the need for alterations in
the Reader.
NOTE The Reader may only be used for the purpose
dened in this chapter, following the user and
safety instructions specied in this manual.
Lifeassays AB does not accept liability for any
damage to people or equipment due to the
misuse of the Reader.
2.1 Contact information and spare parts
LifeAssays AB
Sölvegatan 43A
22370 Lund
SWEDEN
Phone:[phone]
Email: [email protected]
Web: www.lifeassays.com
3 Contents of delivery
The following items are included in the delivery:
• 1 User Manual E-25-0025
• 1 Magnia Reader art no. 50101-10
• 1 USB cable art no. 50201-13
• 1 carrier art no. 50201-14
• 1 battery recharger art no. 50201-16
• 1 “Check calibration” card for manual calibration check
art no. 50201-16
• 2 calibration cartridges for manual calibration check
In case some of these listed items are missing or damaged during
transportation, please contact Lifeassays AB.
WARNING Do not use damaged equipment. It may cause
serious damage or danger to people and/or
equipment.
Magnetic Immunoassay
Reader – Operator Manual
Page 1 of 8
E-25-0025-01
1 Introduction ...................................................................... 1
2 Magnetic Immunoassay Reader ....................................1
2.1 Contact information and spare parts ...................... 1
3 Contents of delivery......................................................... 1
4 Technical information...................................................... 2
4.1 The display ............................................................... 3
4.2 Carrier....................................................................... 4
5. Setting up Reader...............................................................4
5.1 Connecting battery ..................................................4
5.2 Recharging battery .................................................. 4
5.3 Activating Reader..................................................... 5
5.4 Replacing carrier......................................................5
6 Operating Reader ............................................................... 5
6.1 Measuring................................................................. 5
7 Maintenance........................................................................ 6
7.1 Checking calibration ................................................ 6
7.1.1 Manual calibration check................................. 6
7.1.2 Cleaning sensor head ......................................6
7.2 Cleaning Reader....................................................... 7
7.3 Updating software....................................................7
7.4 Replacing battery..................................................... 7
7.5 Storing or transporting Reader................................ 8
8 Troubleshooting ............................................................... 8
8.1 Warning and error messages................................... 8
9 Disposing of Reader ........................................................ 8

4 Technical information
Technical data
Battery recharger supply voltage 100 … 240 V
50 … 60 Hz
Battery 6 V
1650 mAh
NiMH
Product code 2350018
Weight of the Reader 910 g
Dimensions
(width x length x height)
119 x 205 x 74 mm
(without carrier)
No. Part Function
1. Power button is used for switching the
Reader power on and o.
This button is also used for exiting error
message states.
Measure button is used for initiating
the measurement sequence after the
test cartridge has been inserted on the
carrier.
Transfer button is used for transferring
the result from the Reader to a
computer or a printer.
2 Recharging indication
light
This light indicates the status of the
battery recharging.
When the battery is being recharged,
the light blinks. When the light stays on,
the battery is fully recharged.
No function. Reserved for future
updates.
No function. Reserved for future
updates.
No function. Reserved for future
updates.
No function. Reserved for future
updates.
No function. Reserved for future
updates.
3 Test cartridge A test cartridge contains the test that is
being measured.
4 Carrier The carrier positions the test cartridge
correctly for measurement.
Inside the Reader there is a swing bed,
which must be released so that it is
down before the carrier is pushed in.
5. Kensington lock
location
A standard Kensington lock can be
applied to lock the
Reader in place.
Page 2 of 8
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 3 of 8
No. Part Function
1. Memory card slot Dierent kinds of data cards for
dierent purposes – for example a
calibration key or a software update
memory card – are inserted here.
2. USB port The port where the USB cable is
attached for connection with a
computer.
3. RS port The port for connecting external
peripherals, for example a printer.
4. Recharger connection The socket where the recharger is
connected.
No. Part Function
1. Type plate Information about the Reader.
2. Battery hatch screw The screw that needs to be removed
when replacing the battery.
4.1 The display
This is the main view of the display.
The last row gives instructions on what to do to proceed with the
selected task, for example “Insert Test”.
Warning messages are shown on the second last row, if there are any
and the row is not otherwise used. Normally, the second last
row indicates the battery status.
The warning messages are prioritized and the most critical is always
shown.
During the testing sequence, the display shows the
• name of the test
• lot of the test
• expiration date of the test
And gives instructions on how to proceed.
After the measurement is carried out, the
display shows the
• name of the test
• identication number of the measurement
• result of the measurement
And gives instructions on how to proceed.
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 4 of 8
(4.1 The display. Cont.)
Error messages are shown on the display when such a failure occurs
that requires actions to solve the situation. You can return to the display
main view by pressing POWER button.
For more information, see chapter Warning and error messages.
4.2 Carrier
The Reader has a replaceable carrier. Test cartridges of various shapes
and sizes can be read with the same Reader by using a carrier that is
suitable for that particular test cartridge.
New replaceable carriers can be ordered from Lifeassays AB.
5. Setting up Reader
Lifeassays AB follows the quality system according to ISO 13485. The
Reader is designed according to Directive 98/79/EC on in vitro diagnostic
medical devices.
To make sure the Reader operates correctly, the following conditions for
the operational environment must be met.
Operating conditions
Positioning • Do not use or store the Reader in direct
sunlight.
• Do not use the Reader any closer than one
(1) meter from computers, mobile phones or
other electronic appliances.
• Do not use the Reader in strong air current
or draft.
• Place the Reader on stable, horizontal
setting (such as table)
Operating
temperature
+15ºC – +35 ºC
This temperature must be reached before the
Reader can be reliably used
Relative humidity 30 – 90 % (non-condensing)
Ambient air pressure 60 – 120 kPa
CAUTION Quick temperature variations and other external
factors may aect the measurement results.
NOTE Depending on the temperature dierence it may
take hours for the equipment’s temperature to
stabilize to the allowed operating temperature.
5.1 Connecting battery
Before the Reader can be taken into use after storage or transportation,
its battery must be connected and recharged (for recharging see chapter
5.3). When taking rst time the reader into use, the battery is already
located inside the Reader but the battery connection plug is detached for
shipping.
To connect the battery,
1. Turn the Reader upside
down. The battery hatch is in
the bottom of the Reader.
2. Remove the screw of the
battery hatch.
3. Turn the Reader over to
make the battery come loose.
4. Connect the battery
connector.
5. Lower the battery in its
place.
6. Close the battery hatch
with the screw.
5.2 Recharging battery
Before the Reader can be taken into use, its battery must be recharged.
The battery is already installed in the Reader.
It takes approximately 14 hours to recharge an empty battery to full
capacity.
CAUTION Do not use any other type of recharger than the
one especially intended for the Reader.
CAUTION Make sure that battery in connected as
instructed in chapter 5.2..
To recharge the battery,
1. Attach the battery recharger to the Reader.
2. Connect the battery recharger in a wall outlet.
The white light on the Reader’s panel begins to blink, indicating that the
battery is being recharged.
NOTE You may operate the Reader during recharging,
provided that the voltage level is sucient.
If the battery was completely empty, please
allow the battery to be recharged at least for 10
minutes before using the Reader.
3. Disconnect the recharger when the light stops blinking and stays on.
The battery is now fully recharged.
You may leave the Reader connected to the recharger even when the
battery is already full.
NOTE To save battery life time keep the recharger
connected all times expect storage and
transportation, see chapter 7.5.
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 5 of 8
5.3 Activating Reader
To start up the Reader,
1. Push the Power button on the Reader panel.
The Reader starts up.
2. Check the display for warning of low battery.
If the battery is low, recharge the battery as instructed in chapter
Recharging battery.
3. Make sure the swing bed is released to downward position so that the
carrier will not damage the sensor head.
4. Make sure you are holding the carrier the right way.
The thicker head of the carrier goes in the Reader rst.
5. Push the carrier gently into the Reader until it locks in place.
Push the carrier in a slanted position so that the head that goes in rst is
slightly higher than the other end of the carrier.
CAUTION Do not lift the carrier up when pushing it into the
Reader. That might damage the sensor head
inside the Reader.
5.4 Replacing carrier
If some other types of test cartridges are taken into use, the carrier may
have to be replaced by a carrier that matches the used test cartridge
type.
To replace the carrier,
1. Start the Reader.
If the Reader is turned on but the carrier remains in upward position
inside the Reader, restart the Reader to release the swing bed to
downward position.
2. Pull the carrier levelly out from the Reader.
3. Insert the new carrier as instructed in chapter Installing carrier.
6 Operating Reader
6.1 Measuring
NOTE If you want to record the measurement results,
make sure to connect the Reader to a computer
or a printer before you start the measurement
sequence.
To carry out a measurement, follow the instructions 1-14. As an example
of the measuring procedure, the eSAA test is described below.
1. Start the Reader by pressing the Power button. ”Follow testkit
instructions” and then “insert test” are displayed.
2. If you want to record the results to a computer, place the computer
cursor in the desired test result input eld of the software that is used for
recording information.
3. Open the aluminum test pouch having one LifeAssays®test device
and one disposable pipette inside. Insert the LifeAssays®test device into
the Reader so that the small arrow on the end of the test device is visible
and pointing towards you. The sample well marked with “S” will remain
outside the Reader. The Reader prompts: “Use Calibration Key” and then
“ Insert Card”.
4. Insert the Calibration key card into the reader.
CAUTION Make sure the Calibration key and the
test cartridge (lot) match. Otherwise, the
measurement result is not correct.
5. Collect the drop of serum or plasma into the provided glass capillary.
Hold the capillary horizontally and ll completely.
Note: Use the capillary holder (sold as an accessory) for capillary
handling. Avoid the introduction of air bubbles into the glass capillary. Be
sure to ll the entire length of the capillary with serum or plasma. Avoid
excess sample on the outside of the capillary by “wiping o” excess with
a clean tissue.
6. Place the capillary into a sample dilution buer vial and mix by inverting
the tube until the serum or plasma has been completely eluted from the
capillary and mixed with the buer. Note that complete mixing requires
inverting the tube at least 30 times. Tip: For easier and quicker mixing use
the LifeAssays Vortex.
6a. Optionally, instead of using the capillary, add 3 μL of serum or
plasma into the buer vial with a micropipette. Please ensure that no
additional serum or plasma is transferred into the buer vial e.g. via the
pipette tip.
7. Before opening the buer vial, allow the liquid to settle to the
bottom of the tube. If necessary, shake / tap to remove the liquid from the
cap.
8. Aspirate the diluted sample with the pipette provided and add 3
drops to the sample well (round opening in the Cartridge) marked
with “S” and immediately press “MEASURE”.
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 6 of 8
9. Press the Measure button.
CAUTION After you have pressed the Measure button,
do not touch the carrier or the test until the
measurement result is displayed. Prohibiting
the movement of the carrier results to an error
message and / or to a faulty measurement result.
Keep your hands away from the Reader while the
measurement sequence is running.
10. Wait 5 mins for the results of the measurement.
11. Read the test result from the display.
CAUTION Turning o the Reader power or carrying out
another measurement deletes the result from the
Reader permanently. Do not do either of these
actions until you have recorded the measurement
results.
Depending on the instructions given for the
particular test, it may be possible to carry out the
measurement sequence again, in case the results
are lost. Check the development time from the
test specic User Manual.
12. In case the the Reader is connected to computer, you can transfer the
results to the computer
by pressing the Transfer button.
13. Remove the test cartridge from the carrier.
NOTE If you are using the same Calibration key for
more testing, you can continue testing without
removing and re-inserting the card.
14. Turn o the Reader.
NOTE If you do not turn the Reader o, it will turn itself
o automatically if it has not been used for 20
minutes.
7 Maintenance
7.1 Checking calibration
The factory calibration of the Reader can be checked. Calibration check
is recommended to be done as per Quality System of the user. Lifeassays
AB recommends monthly calibration check. Calibration check is
recommended to be conducted always when contamination of the device
is suspected or Reader does not meet user dened system suitability
test.
7.1.1 Manual calibration check
To check calibration manually,
1. Turn on the Reader.
2. Insert the ”Check Calibration” card in the Reader.
3. Insert the calibration cartridge.
4. Press the Measure button.
5. After the results are ready, record them.
6. Compare the results with the allowed values printed on the Calibration
cartridge.
7. Repeat the steps from 3-6 using second Calibration sample.
If the results do not match with the allowed values, clean the sensor
head as instructed in chapter Cleaning sensor head and carry out the
calibration check again from the beginning.
CAUTION Do not inject any liquids into the standard
sample.
If the sensor heads is dirty, it may have
contaminated the standard samples for
calibration as well. Do not try to clean the
samples in any way.
NOTE Store the standard samples in dry place in the
original package.
If there is any doubt of the functionality of the
standard samples, contact Lifeassays AB to order
more samples.
7.1.2 Cleaning sensor head
If the calibration check is unsuccessful, the Reader sensor head must be
cleaned. To clean the sensor head,
1. Turn o the Reader.
2. Remove the carrier as instructed in chapter Replacing carrier.
3. Turn the Reader upside down for the swing bed to open and look inside.
The sensor head is located on the top of the triangular shape inside the
Reader.
4. Clean the sensor head carefully using a cotton tip stick dipped lightly in
a mixture of 70% ethanol and 30% distilled water.
Cleaning mixture can be ordered from Lifeassays AB.
5. Repeat the Calibration check. In case Calibration check does not meet
requirements after repeated cleaning, contact Lifeassays AB.
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 7 of 8
CAUTION Make sure the cotton tip is only lightly saturated
and does not drip mixture inside the Reader.
Do not touch anywhere else than sensor head
with the cotton stick to avoid damaging the
Reader
7.2 Cleaning Reader
Clean the Reader from the outside using a soft cloth moistened with
water or alcohol.
CAUTION Make sure no excess liquid can enter the
openings of the Reader.
7.3 Updating software
If necessary, the software can be easily updated with a dedicated
memory card. Updates may take place for example when new features to
the Reader are introduced.
Lifeassays AB informs you whenever updates for the Reader are
necessary.
NOTE Before updating software, remove the test
cartridge and memory card from the Reader, if
there are any.
To update the Reader software,
1. Start the Reader.
2. Insert the Software update memory card into the Reader.
The Reader loads the update from the memory card automatically. This
process lasts approximately 20 seconds and is indicated by a beeping
signal. When the update is nished, the Reader displays the serial
number and new software version on the display for a few seconds and
then returns to the main display.
3. Remove the Software update memory card from the Reader.
The Reader is now ready to use.
NOTE Software version of the Reader is shown on the
display always when the Reader is turned on.
7.4 Replacing battery
If the Reader gives a warning ”Replace battery”, it means the battery is
closing the end of its lifespan and needs to be replaced with a new one.
CAUTION Do not use any other type of batteries than the
ones especially intended for the Reader.
New batteries can be ordered from Lifeassays AB.
To replace the battery,
1. Turn o the Reader.
2. Turn the Reader upside down.
The battery hatch is in the bottom of the Reader.
3. Remove the screw of the battery hatch.
4. Turn the Reader over to make the battery come loose.
5. Disconnect the battery connector.
CAUTION Be very careful when disconnecting the battery.
Do not pull hard on the wires! The use of tweezers
or other such instrument is recommended.
NOTE For information on how to discard the used
battery, see chapter Disposing of Reader.
6. Connect the new battery.
7. Lower the battery in its place.
8. Close the battery hatch.
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01

Page 8 of 8
7.5 Storing or transporting Reader
To make sure the Reader operates correctly, the following conditions for
the storing and transportation must be met:
• Store the Reader and the batteries in dry conditions in the temperature
between -20ºC – +50 ºC.
• Store the batteries fully recharged, detached from the Reader.
• Remove the carrier when transporting and / or storing the Reader to
avoid damage to the Reader.
• Reattach the piece of cardboard back into the swing bed to protect it
during transportation and / storing.
8 Troubleshooting
8.1 Warning and error messages
The Reader display shows warning and error messages.
Warning messages inform about a problem or a failure, but it is possible
to continue working with the Reader after receiving one.
Warning messages Explanation
USE RECHARGER The Reader battery is running out of
power.
You should recharge the battery as soon
as possible. You can continue working
while the battery is recharging.
NOT CALIBRATED Please contact Lifeassays AB.
TEMPERATURE HIGH High temperature of the Reader may aect
the measurement results.
This warning will disappear when suitable
operating temperature has been reached.
TEMPERATURE LOW Low temperature of the Reader may aect
the measurement results.
This warning will disappear when suitable
operating temperature has been reached.
NOISE LEVEL HIGH Please contact Lifeassays AB.
REPLACE BATTERY The Reader battery is reaching the end of
its lifespan.
The battery needs to be replaced. New
batteries can be ordered from Lifeassays AB.
Error messages inform about a problem or failure and require actions
before you can continue working with the Reader, for example pressing
the POWER button.
NOTE if pressing POWER button does not solve the
situation, contact Lifeassays AB.
Warning messages Explanation
BATTERY
VOLTAGE LOW
The Reader battery is running out of
power.
Connect the Reader to the recharger to
be able to carry out the measurement
sequence. You can continue working while
the battery is recharging.
RECEIVER FAILURE Electronics failure in the receiver.
Press POWER button to return to the main
display view.
TRANSMITTER FAILURE Electronics failure in the transmitter.
Press POWER button to return to the main
display view.
POSITIONING FAILED The position of the carrier is incorrect.
Press POWER button to return to the main
display view.
MOTOR
CURRENT HIGH
The carrier could not be lifted.
Press POWER button to return to the main
display view.
9 Disposing of Reader
When the Reader has reached the end of its lifespan, it must be disposed
of with other electronic waste. The battery must be removed and
disposed of according to the national and / or regional legislations.
Magnia is a registered trademark of Magnasense Technologies Oy.
Latest update of the User Manual 27.09.2017
Manufactured for LifeAssays AB by
Magnasense Technologies Oy
Rajatorpantie 41C
FI-01640 Vantaa
FINLAND
LifeAssays AB, IDEON Science Park, SE-223 70 Lund, Sweden
Phone: [phone], Email: [email protected], Web: www.lifeassays.com
E-25-0025-01