NanoEnTek Frend system User manual

System
User
manual

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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

FRENDTM System © 2012 NanoEntek, Inc.
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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

FRENDTM System © 2012 NanoEntek, Inc.
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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

FRENDTM System © 2012 NanoEntek, Inc.
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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

FRENDTM System © 2012 NanoEntek, Inc.
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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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