tecan M1000 Operating Manual Addendum

m1000™ Operating Manual Addendum
for the Advanced Operator
m1000™ Operating Manual Addendum, 392813, en, V1.1
Manufacturer Address
Tecan Schweiz AG Seestrasse 103 CH-8708 Männedorf Switzerland
Distributor Address
Abbott Laboratories Abbott Park, IL 60064 USA
Document Status Sheet
Title: m1000™ Operating Manual Addendum for the Advanced Operator
ID: 392813
Version Revision Issue Major changes
1 0 may 2003 First issue
1 1 LiHa/RoMa Calibration Procedure updates
New Procedure: Move Plate Test.
© 2003, Tecan Schweiz AG, Switzerland, all rights reserved
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.
Table of Contents
m1000™ Operating Manual Addendum ....................................................... 1
Notices and Symbols .....................................................................................2
NAT Admin Software ...................................................................................... 4
Start NAT Admin ............................................................................................. 5
NAT Worktable ................................................................................................ 6
NAT Options ...................................................................................................7
Table of Contents
Database Maintenance ................................................................................... 7
Restore Database ........................................................................................... 8
Temperature Check ........................................................................................ 9
NAT Teach Worktable Racks and Locations ............................................. 10
Calibrate the LiHa .........................................................................................11
Calibrating the DiTi rack carriers for the LiHa ...........................................15
Removing the DiTi Reference Tip ...............................................................17
Calibrate the RoMa .......................................................................................18
Calibrating the DiTi rack carriers for the RoMa ......................................... 20
Calibrating the DiTi rack shelves for the RoMa .........................................22
Fine-tuning the DiTi rack carriers for the LiHa .......................................... 23
Move Plate Test ............................................................................................25
Disconnect from the Instrument .................................................................25
GENESIS Setup & Service Procedures ...................................................... 26
NAT MBS Worktable ..................................................................................... 27
m1000™ Operating Manual Addendum, 392813, en, V1.1 iii
Table of Contents
Initialise Instrument ......................................................................................29
Dilutor Tool ....................................................................................................30
Door Lock Check ..........................................................................................32
FaWa Test ......................................................................................................36
Liquid Detection Test ...................................................................................40
Lower DiTi Eject Test ...................................................................................43
PosID Test .....................................................................................................46
iv m1000™ Operating Manual Addendum, 392813, en, V1.1
m1000™ Operating Manual Addendum
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.
Categories include: NAT Admin
NAT Worktable NAT Options Database Maintenance Temperature Check NAT Teach Worktable
GENESIS Setup & Service procedures
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™
Operating Manual and this Addendum.
m1000™ Operating Manual Addendum, 392813, en, V1.1 1
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.
2 m1000™ Operating Manual Addendum, 392813, en, V1.1
ATTENTION Symbols
ATTENTIONS appear as follows:
ATTENTIO N
With the general “Read This!” symbol, ATTENTION indicates the possibility of equipment damage, malfunctions, or incorrect process results if instructions are not followed.
m1000™ Operating Manual Addendum, 392813, en, V1.1 3
NAT Admin Software
NAT Admin
Software
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.
4 m1000™ Operating Manual Addendum, 392813, en, V1.1
Start NAT
Admin
The NAT Wizard must be closed to start the NAT Admin. Select the NAT Admin icon. The NAT Admin Login screen is displayed.
Enter User Name and Password (case sensitive) and select <OK>. The NAT Admin main screen is displayed.
m1000™ Operating Manual Addendum, 392813, en, V1.1 5
A
X
NAT Worktable The 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. 1 NAT Admin Worktable
Control Loc
B Input Loc C Output Loc D System Fluid E DiTi Waste F Liquid Waste G 1 ml Subsystem Loc Heater Zone 1 H 1 ml Subsystem Loc Heater Zone 2
Q Shelf Loc 1 R Shelf Loc 2 S Shelf Loc 3 T Shelf Loc 4 U Shelf Loc 5 V Shelf Loc 6 W Shelf Loc 7
Shelf Loc 8
I 1 ml Subsystem Loc RT J 1 ml Subsystem Loc Mag Low K Plate Carrier 1, Loc 1 L Plate Carrier 1, Loc 2 M Plate Carrier 1, Loc 3 N Plate Carrier 2, Loc 1 O Plate Carrier 2, Loc 2 P Plate Carrier 2, Loc 3
1 Trough Loc 1 2 Trough Loc 2 3 Trough Loc 3 7 Trough Loc 7 8 Trough Loc 8 9 Trough Loc 9
6 m1000™ Operating Manual Addendum, 392813, en, V1.1
NAT Options The Options screen allows the operator to configure printers, directories, log
durations, and barcode settings.
Accessing the Options Page:
1 Select the NAT Admin icon.
2 Enter User Name and Password. Select <OK>.
3 The NAT Admin main screen is displayed.
4 Select Options from the NAT Admin main screen.
5 Select Set NAT Options.
Database
Maintenance
Field Description
Default Printer Select the default printer for report printing.
Import Directory Select default directory from which to import files
Export Directory Select default directory to export files.
Days to save log entries Default 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.
m1000™ Operating Manual Addendum, 392813, en, V1.1 7
The backup files will be assigned a name based on the date of backup. For example, NATMBS_db_200304010100.BAK
NATMBS will always precede the name 20030401 is the backup date: Year/Month/Date 0100 is the backup time BAK is the file extension
Restore
Database
1 Select the NAT Admin icon.
2 Enter User Name and Password (case sensitive) and select <OK>.
3 The NAT Admin main screen is displayed.
4 Select Tools from the NAT Admin main menu.
5 Select Database Maintenance.
6 Select the file to restore.
7 Select Restore Now.
8 Select Close to exit to the NAT Admin main menu.
8 m1000™ Operating Manual Addendum, 392813, en, V1.1
Temperature
Check
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:
1 Power on the m1000™, if necessary.
2 Select the NAT Wizard icon from the desktop screen. The Main menu is
displayed.
3 From the Main Menu, select Select Protocol.
4 The Authorization dialog window is displayed. Enter your User Name and
password and select > to proceed to the next screen.
5 Select the Abbott 1 ml Protocol v1.0 or the Generic 1 ml Protocol v1.0 to be
run.
6 Place 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.
7 Select > to proceed.
8 The operator is prompted to initiate the Pre-heat protocol to allow heater
zone 1 to reach correct temperature. Select <OK>.
9 Once 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).
m1000™ Operating Manual Addendum, 392813, en, V1.1 9
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:
1 Select the NAT Admin icon.
2 Enter User Name and Password and select <OK> to continue. The NAT
Admin screen is displayed.
3 Select File from the NAT Admin main screen.
4 Select Teach Worktable Locations.
5 The Teach Worktable Racks and Locations screen is displayed.
10 m1000™ Operating Manual Addendum, 392813, en, V1.1
Fig. 2 Teach worktable locations
6 Select Connect to the Instrument.
Connect to the Instrument
7 The operator is prompted to remove the sample and control racks, reagent
trough carriers, 1 ml subsystem carrier, DiTi racks, waste station chute, and
1.5 ml output tube carriers. Select <OK>.
8 Once the instrument is connected, the Connect to the Instrument button will
display Disconnect from the instrument.
9 Close the Safety door.
10 Select Initialise all Devices. The LiHa, RoMa, and PosID will move to the
Home position and the Instrument status button will change to Instrument Status In Init during initialisation.
11 Once Initialization is complete, the Instrument status button will change to
Instrument Status Connected.
Calibrate the
LiHa
m1000™ Operating Manual Addendum, 392813, en, V1.1 11
Calibrating the 1 ml subsystem for the LiHa
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.
1 Under Calibrate LiHa, select Mount Reference Tip. The DiTi channels will
separate, allowing easy access to install the reference tip to the third DiTi channel.
2 The operator is prompted to mount the reference tip to DiTi #3.
Fig. 3 Mounting the Reference Tip
12 m1000™ Operating Manual Addendum, 392813, en, V1.1
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