NanoEnTek Frend system Manuale utente
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: +82-2-6220-7940
Fax: +82-2-6220-7721
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 specication-normal environmental conditions
Customer support information
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5
6
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8-9
10
11-12
13
14
15-18
19-26
19-26
27-37
27-33
34-37
38-56
38-43
44
45-54
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56
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 specied.
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 specied 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 specic 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 verication 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 specically 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.
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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 qualied 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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Altri manuali per Frend system
1
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