NanoEnTek Frend system User manual

System
User
manual

2
Thank you for purchasing the FRENDTM System.
Please take a few minutes to read this user manual.
If you have any questions at any time, please contact NanoEntek, Inc.
customer support.
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
This manual is considered a necessary part of the device: It must be
available for the operator to use at the bench as well as for the individual
responsible for instrument maintenance.
Read me
first

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Read me first ...........................................................................
Introduction .............................................................................
Warranty ....................................................................................
Introduction ...............................................................................
Intended use .............................................................................
Product components ................................................................
Symbols and abbreviations ......................................................
Safety precautions ....................................................................
General safety warnings ...........................................................
FRENDTM System description ...................................................
The function of the code chip and associated cartridge ..........
Software keys ...........................................................................
Setup .......................................................................................
FRENDTM System setup procedure ..........................................
Operation ................................................................................
FRENDTM System operating procedure ....................................
FRENDTM System data management .......................................
Maintenance ...........................................................................
FRENDTM System maintenance ................................................
Cleaning and storage ...............................................................
Troubleshooting ........................................................................
General specification-normal environmental conditions ..........
Customer support information .................................................
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Table of contents

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NanoEntek Inc. warranties the original purchaser for one (1) year from
the date of its initial purchase that this device and other devices sold
by one of its authorized representatives will function as specified.

NanoEntek Inc. and its representatives shall be relieved of any liability
under this warranty if the product is not used in accordance with the
manufacturer’s instructions, altered in any way not specified by
NanoEntek Inc., not regularly maintained, used with device not approved
by NanoEntek, Inc. or used for purposes for which it was not designed.
This warranty does not apply to damages incurred during the initial
shipment of the instrument and associated auxiliary materials. Any
damages incurred on initial shipment are to be reported immediately
to the freight carrier for the settlement of the claim. Please examine the
device carefully for any damage before signing for the shipment since
your signature indicates receipt of undamaged device.

NanoEntek Inc. will not be responsible for any indirect, incidental, special,
consequential or punitive damages or other losses, including, but not
limited to, damages to or losses of other properties or device.
NanoEntek will not be responsible for personal injuries, whether to the
purchaser or others.
Introduction
Warranty

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The principle of the FRENDTM System
The FRENDTM System is a portable, automated FRENDTM cartridge
reader.
The FRENDTM System is based on quantitative and qualitative
immunoassay technology capable of quantifying single or multiple
analytes by measuring laser-induced fluorescence in a single-use
disposable reagent cartridge.
The FRENDTM cartridge utilizes micro-fluidics lateral flow technology
where the analyte of interest in the sample forms immune complexes
while moving through the fluidics pathway in the cartridge.
The concentration of the analyte of interest in an unknown sample
is calculated using the ratio of the fluorescent intensity of the test
zone and the reference zone.
Introduction
Introduction
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The principle of the fluorescence detection and calculation of the analyte
concentration (drawing from the manual).

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The FREND
TM
System is designed to accommodate the FREND
TM
cartridge, which helps in clinical management of patients by quantitatively
or qualitatively measuring or diagnosing specific antigen or antibodies
in vitro in human specimens.
Introduction
Intended use

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When the FREND™System is received, open the shipping box and
carefully check the package contents. Note that the Q.C. designation
is used in terms of hardware verification of performance not quality
control of the actual testing process for any analytes. Note also that
the mobile printer is included only if it was specifically ordered.
Product
components
Introduction
Main device
Q.C. Cartridge
Quick manual
Adaptor / Power cord
Q.C. Code chip
USB drive
Mobile printer
User manual
Pipettor
Optional Optional

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The following symbols are found on the FRENDTM System user manual
and FRENDTM cartridge package inserts. Please note the meanings of
the symbols and always use the device in a safe manner.
Introduction
Safety
symbols &
abbreviations
Definition
Warning or caution
Biohazard
Class I laser product
Manufacturer
Authorized representative in the European
community
Lot number / Batch number
In vitro diagnostic medical device
Catalogue number / Reference number
Symbol
CLASS 1 LASER PRODUCT

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Safety
symbols &
abbreviations
Introduction
Symbol Definition
When this crossed-out wheeled bin symbol is
attached to a product it means the product is
covered by the European Directive 2012/19/EU.
All electrical and electronic products should
be disposed of separately from the municipal
waste stream via designated collection facilities
appointed by the government or the local
authorities.
The correct disposal of your old appliance will
help prevent potential negative consequences
for the environment and human health.
For more detailed information about disposal
of your old appliance, please contact local
distributor, waste disposal service or call the
number listed in the manual.
Disposal of your old appliance
1.
2.
3.
4.

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Thoroughly read all instructions before attempting to operate this device.
Pay particular attention to all safety precautions. The following guidelines
must be observed during every phase of operation. Breaking these
rules may be dangerous, illegal or affect performance of the device
and/or invalidate the device approval and/or warranty. In order to
avoid instrument damage or personal harm, read this manual carefully
and follow the instructions given.
Always ensure that the power supply input voltage matches the
voltage available in your location.
This machine is air-cooled so its surface becomes warm during operation.
When installing the device on the countertop always leave a space
of more than 10 cm (4 inches) around the instrument in all directions.
Leave adequate distance between the back of the instrument and
the wall to allow the operation of the ‘on’ and ‘off’ power switch.
This location must also be accessible to load the Q.C. Code chip
and the test code chips.
Do not insert metallic objects into the FREND™System as this could
result in an electrical shock, personal injury and device damage.
insert only qualified and authorized devices supplied by NanoEntek Inc.
Do not insert any foreign materials into the air vent or the speaker.
Always set the main switch to the ‘off’ position before connecting
the power cord to the wall outlet.
When unplugging the power cord, be certain to turn the main switch
off, then unplug the power cord.
NOTE : This device has been tested and found to comply with the
limits for a Class A digital device, pursuant to part 15 of the FCC rules.
These limits are designed to provide reasonable protection against
harmful interference when the device is operated in a commercial
environment. This device generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications.
Operation of this device in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference
at his own expense.
Introduction
Safety
precautions
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Lisez attentivement toutes les instructions avant d'utiliser cet équipement.
Faites particulièrement attention à toutes les précautions de sécurité.
Les directives suivantes doivent être respectées au cours de chaque
opération. Ne pas respecter ces règles peut être dangereux, illégal
ou affecter les performances de l'équipement et / ou invalider
l'approbation et / ou la garantie de l'équipement. Afin de vous éviter
des dommages et d’éviter d’en causer aux instruments, lisez attentivement
ce manuel et suivez les instructions données.
Veillez toujours à ce que la tension d'entrée de l'alimentation
corresponde à la tension disponible dans sur votre site de travail.
Cette machine est refroidie par air, sa surface devient chaude pendant
le fonctionnement. Lors de l'installation de l'équipement sur le
comptoir, laissez toujours un espace de plus de 10 cm (4 pouces)
autour de l'instrument dans toutes les directions.
Laissez une distance suffisante entre l'arrière de l'instrument et
le mur pour permettre d’actionner l'interrupteur 'ON' (Marche) et
'OFF'(Arrêt). Cet espace permet également de charger la puce
électronique Q.C. (la puce électronique de test).
N'insérez pas d'objets métalliques dans FREND™ System car cela
pourrait provoquer un choc électrique, des blessures corporelles et
des dommages matériels. Insérez uniquement des appareils quali-
fiés et autorisés fournis par NanoEntek Inc.
N'insérez aucun matériau étranger dans l'évent ou dans le haut-parleur.
Veillez à toujours régler l'interrupteur principal sur la position «OFF»
avant de connecter le cordon d'alimentation à la prise murale.
Lorsque vous débranchez la machine, assurez-vous d’abord
d'éteindre l'interrupteur principal, puis débranchez le cordon
d'alimentation.
REMARQUE : Cet équipement a été testé et s'est avéré conforme aux
limites d'un appareil numérique de classe A, conformément à la partie
15 des règles de la FCC.
Ces limites sont conçues pour fournir une protection raisonnable contre
les interférences nuisibles lorsque l'équipement est utilisé dans un
environnement commercial. Cet équipement génère, utilise et peut
émettre de l'énergie radiofréquence et, s'il n'est pas installé et utilisé
conformément au mode d'emploi, peut causer des interférences nuisi-
bles aux communications radio.
Le fonctionnement de cet équipement dans une zone résidentielle
est susceptible de causer des interférences nuisibles, auquel cas
l'utilisateur sera tenu de corriger l'interférence à ses frais.
Introduction
Précautions
de sécurité
•
•
•
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•

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Before using the device, read this manual and be certain you thoroughly
understand it’s contents.
Please follow the instructions in this manual to assure proper operation
of the device.
When not in use, unplug the device from the electrical outlet.
Perform regular maintenance checks on the main body of the instrument.
Inspect all components.
After long term storage, take extra care to be sure the device operates
correctly.
Avoid handling or storing liquid on or near the device.
Do not open the machine at any time while it is operating or when it
is plugged in to the wall outlet.
Keep the instrument away from open flames and or smoke.
When moving the device, unplug it and move it carefully and gently.
The instrument should be placed on a flat and stable surface.
Refer to this manual for handling and/or maintenance.
Keep the device (including the cable and the plug) out of reach of
children.
Disposal management.
General
safety
warnings
Introduction
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•
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•
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Local regulations governing the disposal of materials containing
biohazardous materials must be observed. It is in the responsibility
of the user to arrange for the proper disposal of these items.
All instrument parts which may be contaminated with potentially
infectious materials must be disinfected by suitable validated procedures
(autoclaving, chemical treatment) prior to disposal if this is required
by the regulations under which your site operates.
The device itself and the electronic accessories must be disposed
of according to the regulations for the disposal of electronic components.
Be sure to understand what the rules at your site are.

FRENDTM System © 2012 NanoEntek, Inc.
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Do not attempt to disassemble/modify the device.
Do not insert foreign objects into the device and insert only NanoEntek
Inc. provided cartridges.
Do not handle the device or the power cord with wet hands.
Do not move, tilt, jar or shake the device when it is in operation.
Do not store the device in direct sunlight, high/low temperatures or
high humidity.
Do not throw, drop, hit or push the device.
Do not touch the device or the plug during an active thunder and/
or lightning storm.
Do not touch the LCD panel with sharp objects.
Do not use the device, if it has any damaged parts (including the
power cord or the plug).
There is a risk of explosion, if the instrument
battery is replaced with an incorrect type.
Class A device is intended for use in an
industrial environment. In the documentation
for the user, a statement shall be included
drawing attention to the fact that there
may be potential difficulties in ensuring
electromagnetic compatibility in other
environments, due to conducted as well
as radiated electromagnetic disturbances
from the instrument itself.
The cartridge should be inserted into the
device within the stipulated time.
The instrument should be used in a clean
environment.
Ensure the sample is not contaminated
by any foreign material or contain fibrin
clots.
Human samples and controls should be
considered potentially infectious.
Introduction
General
safety
warnings
•
•
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Warning
or caution
Biohazard

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Function
Slot for FRENDTM cartridge insertion and
ejection
Show the operating status and results
Pathway to dissipate internal heat to the
outside
Screen touch, results and error tones
Power on/off
Power supply
Use to connect to a USB drive.
Use to connect to a PC. (manufacturer
or supplier only)
Slot for QC or cartridge Code chip
insertion and ejection
Connection for an optional mobile
printer
FRENDTM
System
description
Introduction
Name
Cartridge slot
Screen
Ventilation
Speaker
Power switch
Power supply port
USB H
USB D
Code chip slot
Serial port
Cartridge slot
Ventilation
Power switch
Power supply port
USB H
USB D
SpeakerScreen
Code chip slot
Serial port

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Introduction
The function
of the code
chip and
associated
cartridge
Product
Q.C. Code chip
Q.C. Cartridge
Product
Analyte code
chip
Analyte cartridge
Definition
The chip containing information for the
proper functioning of the Q.C. Cartridge.
The cartridge used to check the
mechanics and optics of the FREND™
System.
Definition
The cartridge code chip is specific for a
given analyte and lot of reagent.
It contains information on calibration
and calculation of results using readings
from the FRENDTM reagent cartridge.
The cartridge contains reagents and
microstructures to support a lateral flow
assay, where analytes of interest form
immune complexes while the specimen
is moving and being separated. Ratio
between test zone and reference zone is
calculated.

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Main screen
Software
keys
Introduction
Button
TEST
DATA
SETUP
Purpose
Check and search results. Back up the
data and transfer the data to a USB
drive.
Set up the FREND™ System
parameters specific for the site and
operator.
Initiates a test sequence for an analyte
using that analyte-specific cartridge.

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Setup screen
Software
keys
Introduction
Button
Purpose
Allows the user to check the serial
number, software or firmware version, and
the production date of the instrument.
Allows for software updates.
Allows entry requirements and Lab ID.
Move to the main screen. (HOME)
Allows user to check the information on
the Q.C. or the cartridge code chip.
Allows the user to check the cartridge
ID and its associated lot number.
Location to adjust the time and date for
the FRENDTM system.

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Data screen
Button
Purpose
Enter the file name to later identify the data.
Search files or data.
Home button. Move to the main screen.
View the information of the selected file or
data.
Print the detailed data, using the
optional printer if it is connected to the
system.
Software
keys
Introduction
Backup a selected set of data to the
connected USB drive.

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Data screen
Button
Purpose
Delete one selected piece of data.
Display the selected data.
Backup all the saved data to the
connected USB drive.
Delete all the saved data. (confirmation
required)
Select data by moving one file at a time.
Select data by moving one page at a
time.
Software
keys
Introduction

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1. Carefully examine the box for damage. Remove all components of
the FRENDTM System from the box.
2. Plug the power cord into the adaptor.
3. Carefully examine the adaptor
and make certain it is compatible
with the power at the plug location.
If it is the appropriate adaptor,
plug the adaptor into the FRENDTM System
and the AC power cord into the wall socket.
Warning:
If you use an incorrect adaptor, the FRENDTM System may explode or
start to burn. If this happens, it will no longer work properly anymore.
4. Turn the power switch to the ON position.
5. While the system is booting up, this image will appear.
6. Check the main screen.
FRENDTM
System setup
procedure
Power switch
Setup