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 equipment: It must
be available for the operator to use at the bench as well as for the indi-
vidual responsible for instrument maintenance.
Read me
rst

FRENDTM System © 2012 NanoEnTek Inc. 3
Read me rst
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 specication-normal environmental conditions
Customer support information
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11-12
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15-18
19-26
19-26
27-37
27-33
34-37
38-56
38-43
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45-54
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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 equipment and other devices
sold by one of its authorized representatives will function as specied.

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 specied by Na-
noEnTek Inc., not regularly maintained, used with equipment not ap-
proved 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
equipment carefully for any damage before signing for the shipment
since your signature indicates receipt of undamaged equipment.

NanoEnTek Inc. will not be responsible for any indirect, incidental, spe-
cial, consequential or punitive damages or other losses, including, but
not limited to, damages to or losses of other properties or equipment.
NanoEnTek will not be responsible for personal injuries, whether to the
purchaser or others.
Introduction
Warranty

FRENDTM System © 2012 NanoEnTek Inc. 5
The principle of the FRENDTM System
The FRENDTM System is a portable, automated FRENDTM cartridge
reader.
The FRENDTM System is based on quantitative immunoassay tech-
nology capable of quantifying single or multiple analytes by measur-
ing laser-induced uorescence in a single-use disposable reagent
cartridge.
The FRENDTM cartridge utilizes micro-uidics lateral ow technology
where the analyte of interest in the sample forms immune complexes
while moving through the uidics pathway in the cartridge.
The concentration of the analyte of interest in an unknown sample is
calculated using the ratio of the uorescent intensity of the test zone
and the reference zone.
Introduction
Introduction
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The principle of the uorescence detection and calculation of the analyte con-
centration (drawing from the manual).

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The FREND™System is designed to accommodate the FREND™car-
tridge in which a quantitative in vitro measurement of specic antigens
in human serum or plasma are made to be used as an aid in the clinical
management of patients.
Introduction
Intended use

FRENDTM System © 2012 NanoEnTek Inc. 7
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 verication 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 specically ordered.
Product
components
Introduction
Main body
Q.C. Cartridge
Quick manual
Adaptor / Power cord
Q.C. Code chip
USB drive
Mobile printer
Q.C. Pouch
User manual
Pipettor
Optional Optional
System
Q.C. Pouch
[Components]
1 x Q.C. Cartridge 1 x Q.C. Code chip

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The following symbols are found on the FREND™ System and in the
manual and package inserts. Study the meanings of the symbols and
always use the equipment in a safe manner.
Introduction
Safety
symbols &
abbreviations
Definition
Warning or caution
Biohazard
Class I laser product
Manufactured by
Authorized representative in the european
community
Lot number
In vitro diagnostic medical device
Catalogue number
Symbol
CLASS 1 LASER PRODUCT

FRENDTM System © 2012 NanoEnTek Inc. 9
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.

10
Thoroughly read all instructions before attempting to operate this equip-
ment. Pay particular attention to all safety precautions. The following
guidelines must be observed during every phase of operation. Break-
ing these rules may be dangerous, illegal or affect performance of the
equipment and/or invalidate the equipment 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 volt-
age available in your location.
This machine is air-cooled so its surface becomes warm during
operation. When installing the equipment 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 equipment damage.
insert only qualied 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 equipment 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 equipment is operated in a commercial
environment. This equipment 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 commu-
nications. Operation of this equipment 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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•

FRENDTM System © 2012 NanoEnTek Inc. 11
Before using the equipment, read this manual and be certain you
thoroughly understand it’s contents.
Please follow the instructions in this manual to assure proper opera-
tion of the equipment.
When not in use, unplug the equipment from the electrical outlet.
Perform regular maintenance checks on the main body of the instru-
ment. Inspect all components.
After long term storage, take extra care to be sure the equipment
operates correctly.
Avoid handling or storing liquid on or near the equipment.
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 ames and or smoke.
When moving the equipment, unplug it and move it carefully and gently.
The instrument should be placed on a at and stable surface.
Refer to this manual for handling and/or maintenance.
Keep the equipment (including the cable and the plug) out of reach
of children.
Disposal management.
General
safety
warnings
Introduction
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Local regulations governing the disposal of materials containing bio-
hazardous 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 pro-
cedures (autoclaving, chemical treatment) prior to disposal if this is
required by the regulations under which your site operates.
The equipment itself and the electronic accessories must be dis-
posed of according to the regulations for the disposal of electronic
components. Be sure to understand what the rules at your site are.

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Do not attempt to disassemble/modify the equipment.
Do not insert foreign objects into the equipment and insert only Na-
noEnTek Inc.-provided cartridges.
Do not handle the equipment or the power cord with wet hands.
Do not move, tilt, jar or shake the equipment when it is in operation.
Do not store the equipment in direct sunlight, high/low temperatures
or high humidity.
Do not throw, drop, hit or push the equipment.
Do not touch the equipment or the plug during an active thunder and/
or lightning storm.
Do not touch the LCD panel with sharp objects.
Do not use the equipment, if it has any damaged parts (including the
power cord or the plug).
There is a risk of explosion, if the instru-
ment battery is replaced with an incorrect
type.
Class A equipment is intended for use in
an industrial environment. In the docu-
mentation 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 distur-
bances from the instrument itself.
The cartridge should be inserted into the
equipment 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
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Warning
or caution
Biohazard

FRENDTM System © 2012 NanoEnTek Inc. 13
Function
Location to insert or remove theFREND™
cartridge
Show the operating status and results
Pathway to dissipate internal heat to the
outside
Operational instructions and warning
indicators
Power on/off
Power supply
Use to connect to a USB drive.
Use to connect to a PC. (manufacturer
or supplier only)
Location for the insertion of Q.C. or
cartridge code chip
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 DSpeaker
Screen
Code chip slot
Serial port

14
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.

FRENDTM System © 2012 NanoEnTek Inc. 15
Main screen
Software
keys
Introduction
Button designation
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 of the user name.
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.

FRENDTM System © 2012 NanoEnTek Inc. 17
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 location at
a time.
Select data by moving one page at a
time.
Software
keys
Introduction

FRENDTM System © 2012 NanoEnTek Inc. 19
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

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7. Press the SETUP button on the main screen.
8. Press the Date & Time button on the setup screen.
9. Set the local date and time.
10. After setting the date and time, press the OK button to return to
the setup screen.
11. Press the USER button on the setup screen.
FRENDTM
System setup
procedure
Setup
2012
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