Information contained in this document is subject to change without notice.
Pictorial Disclaimer
The screens and figures contained in this manual are for information and illustration purposes only. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information on the screens and figures in this manual; their information is
not to be used for clinical or maintenance evaluation.
Read this information prior to using the NAT Admin or the GENESIS Setup &
Service software features. This information should be used in conjunction with
the m1000™ Operating Manual.
This information is issued by Abbott Diagnostics Division to provide you with
advanced m1000™ information.
Intended Use of Operating Manual Addendum:
This manual supports the operator of the m1000™ with instrument calibration
and troubleshooting procedures.
This manual does not enable the operator to generate user-defined protocols.
It is strongly recommended that operators contact Abbott Laboratories for
assistance with any protocol or process step change.
NAT MBS Worktable
Initialise Instrument
Dilutor Tool
Door Lock Check
FaWa Test
Liquid Detection Test
Lower DiTi Eject Test
PosID Test
User Qualification
The laboratory personnel must be qualified and trained to operate the m1000™.
The operators must fulfill the following qualifications to perform the procedures
described in this Addendum:
They must have a thorough knowledge of the applications run on the system.
They must be familiar with the Good Laboratory Practice guidelines or
equivalent guidelines.
They must have read and understood the instructions in the m1000™
Note: Abbott offers onsite training for the primary operator. Abbott recommends
that the primary operator attend this primary operator training course.
Notices and
Symbols
Warning Notices Used in this Manual
The symbols used for safety-related notices have the following significance:
Warning Symbols
WARNINGS appear as follows:
WARNING
Generally, the triangular warning symbol indicates the possibility of personal injury
or even loss of life if the instructions are not followed.
Whenever possible, the symbol indicates the hazard a person is exposed to more
specifically. The symbols used in this Operating Manual Addendum have the
following significance:
WARNING
Potentially infectious material
Indicates an area where the operator may be exposed to infectious material.
WARNING
Automatically moving parts.
Injuries (crushing, piercing) possible, if the safety panels are not in place.
Before starting the m1000™, make sure that the safety door is closed.
Never operate the instrument without panels on and door closed.
WARNING
Laser Hazard
Identifies a Class II laser product that contains an embedded low power
visible Class II laser diode barcode scanner. Warns against direct viewing into
barcode laser beam or reflections from the beam.
WARNING
Hot Surface Hazard: Identifies an area where the operator may be exposed to hot
surfaces, such as heater zone 1 and heater zone 2.
With the general “Read This!” symbol, ATTENTION indicates the possibility of
equipment damage, malfunctions, or incorrect process results if instructions are
not followed.
The NAT Admin software allows you to configure the m1000™ with information to
meet your site’s specific requirements.
WARNING
The Abbott 1 ml Protocol v1.0 cannot be edited.
The use of the Abbott sample preparation kit and the provided Generic 1 ml
Protocol will allow an operator successful RNA separation. The Generic 1 ml
Protocol processes all specimens and controls as samples. Because the NAT
software does not check dependencies of process steps, instrument damage
and/or poor specimen yield and purity may result from any protocol or process
step change. It is strongly recommended that users contact Abbott Laboratories
for assistance with any protocol or process step change. Technical Support may
be limited for any changes to the Generic 1 ml Protocol not recommended by
Abbott Laboratories. The user has sole responsibility to verify and/or validate any
user-defined protocols.
WARNING
Automatically moving parts.
Injuries (crushing, piercing) possible, if the safety panels are not in place.
Before starting the m1000™, make sure that the safety door is closed.
Never operate the instrument without panels on and door closed.
WARNING
Potentially infectious
Instrument parts may be contaminated with potentially infectious materials.
Follow basic biohazard precautions
Wear appropriate personal protective equipment, such as gloves, lab coats
and protective eye wear
WARNING
The operator may be exposed to hazardous chemicals when handling sample
preparation reagents. The exposure to hazardous chemicals is minimized by
following instructions provided in produce-specific labels and product-specific
Material Safety Data Sheets (MSDS). Wear appropriate personal protective
equipment, such as gloves, lab coats, and protective eye wear.
NAT WorktableThe following figure shows the m1000™ worktable locations used in NAT Admin
software:
X
W
V
U
T
S
R
Q
7
N
K
1
H
G
A
J
I
B
L
2
M
3
8
O
P
C
9
E
D
F
Note: Worktable locations are fixed and cannot be changed.
Fig. 1NAT Admin Worktable
Control Loc
BInput Loc
COutput Loc
D System Fluid
EDiTi Waste
FLiquid Waste
G1 ml Subsystem Loc Heater Zone 1
H1 ml Subsystem Loc Heater Zone 2
QShelf Loc 1
RShelf Loc 2
SShelf Loc 3
TShelf Loc 4
UShelf Loc 5
VShelf Loc 6
WShelf Loc 7
Shelf Loc 8
I1 ml Subsystem Loc RT
J1 ml Subsystem Loc Mag Low
KPlate Carrier 1, Loc 1
LPlate Carrier 1, Loc 2
MPlate Carrier 1, Loc 3
NPlate Carrier 2, Loc 1
OPlate Carrier 2, Loc 2
PPlate Carrier 2, Loc 3
1Trough Loc 1
2Trough Loc 2
3Trough Loc 3
7Trough Loc 7
8Trough Loc 8
9Trough Loc 9
NAT OptionsThe Options screen allows the operator to configure printers, directories, log
durations, and barcode settings.
Accessing the Options Page:
1Select the NAT Admin icon.
2Enter User Name and Password. Select <OK>.
3The NAT Admin main screen is displayed.
4Select Options from the NAT Admin main screen.
5Select Set NAT Options.
Database
Maintenance
FieldDescription
Default PrinterSelect the default printer for report printing.
Import DirectorySelect default directory from which to import files
Export DirectorySelect default directory to export files.
Days to save log entriesDefault is 100
Barcode Settings
Code 2/5 Interleaved*
Codabar
Note: Barcode length for Code 2/5 must be an even number of characters. The
*
Configure the appropriate barcode length
Select 2 to 30
Select 1 to 31
barcode length configured should include the check digit and extra character, if
necessary, for an even number of characters.
Database Maintenance is performed daily at 01:00 a.m. in the form of a daily
backup. In the case of a database corruption, a previous database can be
restored.
The temperature check for the 1 ml subsystem should be performed according to
your laboratory procedures or as directed for troubleshooting. Refer to the
m1000™ Operating Manual, Chapter 8, Troubleshooting, for additional
assistance.
WAR NING
Potentially infectious
Instrument parts may be contaminated with potentially infectious materials.
Follow basic biohazard precautions
Wear appropriate personal protective equipment, such as gloves, lab coats
and protective eye wear
WAR NING
Hot Surface Hazard: Identifies an area where the operator may be exposed to hot
surfaces, such as Heater Zone 1 and Heater Zone 2.
Perform the following steps:
1Power on the m1000™, if necessary.
2Select the NAT Wizard icon from the desktop screen. The Main menu is
displayed.
3From the Main Menu, select Select Protocol.
4The Authorization dialog window is displayed. Enter your User Name and
password and select > to proceed to the next screen.
5Select the Abbott 1 ml Protocol v1.0 or the Generic 1 ml Protocol v1.0 to be
run.
6Place one reaction vessel in the 1 ml subsystem carrier (any location). Add
approximately 1 ml of water, or enough to cover the base of the thermometer.
Place the 1 ml subsystem carrier into heater zone 1.
7Select > to proceed.
8The operator is prompted to initiate the Pre-heat protocol to allow heater
zone 1 to reach correct temperature. Select <OK>.
9Once heater zone 1 reaches the correct operating temperature, the operator
is prompted Heater Zone 1 Achieved Operating Temperature. Select
<OK>.
10 Insert a thermometer into the reaction vessel in heater zone 1. Allow to
equilibrate to 50°C (± 2.5°C). Verify this temperature is 50°C (± 2.5°C).
Note: DO NOT place the thermometer into the reaction vessel until the Scan
Rack screen displays.
11 Move the 1 ml subsystem carrier to heater zone 2. Allow the thermometer to
equilibrate to 75°C (± 2.5°C). Verify this temperature is 75°C (± 2.5°C).
12 If the temperature for heater zone 1 and heater zone 2 are not within the
specified range, repeat this procedure. Do not run a sample preparation
protocol until the temperature for both heater zones are correct. Refer to the
m1000™ Operating Manual, Chapter 8, Troubleshooting, for additional
assistance.
13 Remove the thermometer.
14 Select < twice to return to the Main Menu.
NAT Teach
Worktable
Racks and
Locations
The liquid handling arm (LiHa) and robotic manipulator arm (RoMa) must be
calibrated with the GENESIS Setup & Service software by an Abbott Field
Service Engineer. In addition, once the GENESIS Setup & Service Worktable
calibrations are performed, the NAT software requires calibration. This can be
performed using the Teach Worktable Racks and Locations screen.
In addition, the vertical and horizontal position for the LiHa and RoMa for carriers
and racks on the m1000™ worktable must be determined by using the NAT
Admin Teach Worktable Racks and Locations procedures.
General Information
WARNING
Automatically moving parts.
Injuries (crushing, piercing) possible, if the safety panels are not in place.
Before starting the m1000™, make sure that the safety door is closed.
Never operate the instrument without panels on and door closed.
WARNING
Potentially infectious
Instrument parts may be contaminated with potentially infectious materials.
Follow basic biohazard precautions
Wear appropriate personal protective equipment, such as gloves, lab coats
and protective eye wear
WARNING
All carriers and racks must be removed from the m1000™ worktable, including the
sample and control racks, reagent trough carriers, 1 ml subsystem carrier, DiTi
racks, waste station chute, and 1.5 ml output tube carriers. Failure to remove
these instrument accessories could result in crashing and damage to the LiHa,
calibration reference tip, and/or the RoMa.
To access the Teach Worktable Racks and Locations screen:
1Select the NAT Admin icon.
2Enter User Name and Password and select <OK> to continue. The NAT
Admin screen is displayed.
3Select File from the NAT Admin main screen.
4Select Teach Worktable Locations.
5The Teach Worktable Racks and Locations screen is displayed.
During this step, the LiHa is calibrated to correctly aspirate and dispense
specimens, controls, and reagents into the reaction vessels. This calibration will
include X, Y, and Z direction.
The LiHa can move in three different
directions:
X: arm movement left and right
Y: tip movement and spacing front and rear
Z: range for tip movement up and down.
The target for the 1 ml subsystem is the small indention in the center of each
zone. The reference tip should just touch the target in the X and Y direction and
the tip of the reference tip must touch or just be level with the surface of each
zone.
1Under Calibrate LiHa, select Mount Reference Tip. The DiTi channels will
separate, allowing easy access to install the reference tip to the third DiTi
channel.
2The operator is prompted to mount the reference tip to DiTi #3.