®

S Y S T E M

List Number
ber 04J73-01
3-01

Abbott Laboratories 2002 Abbott Laboratories

Abbott Park, IL 60064 AxSYM is a Registered Trademark
69970-101—June 2002 of Abbott Laboratories
Patents Pending
Foreword
Your AxSYM® System represents advancements in immunoassay
testing and laboratory instrumentation.
It is extremely important to us that you operate and maintain the
system safely, efficiently, and confidently.
To this end, we offer customer support in several forms:
• This addendum is designed to be used in conjunction with the
current AxSYM System Operations Manual. Please examine it
carefully and become familiar with its contents.
• Technical assistance is available. This gives you access to our
specially trained staff of Abbott Customer Support Specialists
and Field Service Representatives.
Together
gether we can make sure this outstanding system achieves its full
potential in your laboratory.

Customer Support
Abbott Laboratories Diagnostics Division
Contact your Area Customer Support.

Intended Use
The Abbott AxSYM M System is a fully automated Immunoassay
analyzer designed to perform Microparticle Enzyme Immunoassay
(MEIA),
A), Fluorescence Polarization Immunoassay (FPIA), Radiative
Energy Attenuation (REA®) Assay Technology, and d Ion Capture
(IC) Immunoassay Technologies. The AxSYM System performs
random access, continuous access, and STATTAT processing of both
large and small molecular weight analytes.
The Abbott AxSYM
xSYM System is designed for the performance of
routine immunoassays and analytelyte determinations such as those
required by hospitals and reference laboratories.

Proprietary
ary Statement
AxSYM
SYM System software programs and system documentation are
protected by copyright.
ht. All rights are reserved.
The software and manuals were developed solely for use with
Abbott
bbott Laboratories equipment, for in vitro diagnostic applications
as specified in the operating instructions.

ii ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
 Copying
ying or otherwise reproducing these materials, including
computerization, for other than archival purposes is prohibited
without the prior written consent of Abbott Laboratories.

Pictorial Disclaimer
mer
All samples (printouts, graphics, displays, screens, etc.) are for
information and illustration purposes only and shall not be used
for clinical or maintenance evaluations. Data shown in sample
printouts and screens do not reflect actual patient names or test
results.

Abbott Instrument
strument Warranty
arranty
(U.S. customers
mers only)
Abbott Laboratories (Abbott) warrants the AxSYM® System
ystem
(System) to be free from defects in workmanship and materials for
use by the original
ginal purchaser, excluding items subject to wear and
tear which require replacement during normal use as a matter of
course. This warranty shall continue for a period of one (1) year
commencing twenty-one (21) 21) days from the date of system
shipment, referred to as the Warranty Period.
If a defect should
ld occur during the Warranty Period, the purchaser
must contact the Abbott
bbott Customer Support Center immediately
and provide details.
This warranty does not cover defects or malfunctions which are
not reported during the Warranty Period, or which result from any
of the following:
• Use of any vessel, reagent, or system disposable
posable not supplied
by Abbott
• Reuse of any system disposable
• Chemical decomposition or corrosion
• Failure to comply with any requirement or instruction in the
current System Operations Manual
• Repair or modification without prior Abbott authorization
• Negligent or intentional abuse or misuse of the System

ABBOTT AxSYM®® SYSTEM Bulk Solution Dispensers Addendum iii

69970-101—June 2002
 Liability for all matters arising from the supply, installation, use,
repair and maintenance ce of the system, whether arising under this
warranty or otherwise, shall be limited solely to the repair or, at
Abbott’s sole discretion, replacement of the System or
components. Replaced parts shall become the property of Abbott.
In no event shall Abbott be liable for injuries
juries sustained by third
parties, for incidental or consequential damages, or for lost profits.
ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND D OR NATURE WITH RESPECT TO THE
INFORMATION.
MATION. ABBOTT LABORATORIES HEREBY DISCLAIMS
ALL REPRESENTATIONS
PRESENTATIONS AND WARRANTIES, WHETHER EXPRESS
OR IMPLIED,
LIED, CREATED BY LAW, CONTRACT OR OTHERWISE,
INCLUDING,
UDING, WITHOUT LIMITATION, ANY WARRANTIES ES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
TITLE OR NON-INFRINGEMENT. IN NO EVENT
VENT SHALL ABBOTT
LABORATORIES BE LIABLE FOR ANY DAMAGES
GES OF ANY KIND OR
NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT,
INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT)
CONSEQUENTIAL
QUENTIAL OR INCIDENTAL DAMAGESS ARISING FROM
OR IN CONNECTION WITH THE EXISTENCE
XISTENCE OR USE OF THE
INFORMATION, REGARDLESS
DLESS OF WHETHER ABBOTT
LABORATORIES HAS BEEN ADVISED AS TO THE POSSIBILITY OF
SUCH DAMAGES.
GES.

Safety Agency
gency Approvals
ovals
This equipment has been tested and found to comply
y with:
• Part 15 of the FCC rules for radiated emissions
• EN
N 55011A for radiated and conducted emissions
• EN 50082-1 for power line voltage fluctuation immunity
• IEC 801-1
01-1 for general electro-magnetic compatibility
• IEC 801-22 for electrostatic discharge
• IEC 801-3 for radiated susceptibility
ptibility
• IEC 801-4 for electrical fast transients
• IEC 801-5 for power
wer line voltage surges
• IEC 801-6 for conducted radio frequency
quency immunity

Trademark
mark Statement
AxSYM is a registered trademark off Abbott Laboratories.
REA is a registered trademark of Abbott Laboratories.
Phillips is a registered trademark of Phillips Screw Company

iv ABBOTT AxSYM® SYSTEM Bulk Solution

tion Dispensers Addendum
69970-101—June 2002
Bulk Solution Dispensers
pensers Addendum

Overview
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Weekly Maintenance
Cleaning Dispenser Nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Decontamination
Tubing
g Decontamination – 5% Dilution Procedure . . . . . . . . . 7
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum Table of Contents-1

69970-101—June 2002
Table of Contents Bulk
lk Solution Dispensers
ensers Addendum

NOTES

Table of Contents-2 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Overview
iew

Section 9. Overview

This addendum includes information about

bout the Bulk Solution
Dispensers on the AxSYM System
ystem and should be used in con-
junction with the AxSYM System
m Operations Manual (List
No. 9A26).
A26).
This Bulk Solution Dispensers Addendum
m addresses the follow-
ing topics:
• Weekly Maintenance
Cleaning Dispenser Nozzles
• Decontamination
Tubing
ubing Decontamination

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 1

69970-101—June 2002
Overview Bulk Solution Dispensers Addendum

NOTES

2 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk Solution Dispensers Addendum Weekly
ly Maintenance

Section 9. Weekly Maintenance

This section includes information about the weekly

y mainte-
nance procedure, Cleaning Dispenser Nozzles, on the
he AxSYM
System.

Cleaning Dispenser
penser Nozzles
Clean the Dispenser Nozzles to eliminate any salt buildup.

CAUTION: N: Potential assay impact. For more

! details, refer to Section 8: Hazards, Subsection:
Procedural Hazards.

Materials Required
• Cotton swabs
• Wash bottle with sterile water
• No. 2 Phillips head screwdriver
crewdriver
• Nylon Stylet

Procedure
This procedure requires opening the Processing Center Cover.

NOTE: Instructions for opening the Processing

Center Cover are provided in the Abbott AxSYM
SYM
Training Program. Contact the Abbott Customer
ustomer
Support Center.

Remove and clean one Dispenser at a time to avoid reinstalling

a Dispenser in the wrong location.

1. Remove the Matrix Cell Hopper.

2. Open the Processing Center Cover.
3. Remove the Bulk
ulk Solution 1 Dispenser. Push the release
button, the green button to the right side of the lever, in
the direction of the arrow
w to unlock the lever. Lift the dis-
penser out of the slots in the unlocked lever.
4. Invert the Dispenser to inspect the Nozzles
zzles for buffer de-
posits.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 3

69970-101—June 2002
Weekly Maintenance
tenance Bulk Solution Dispensers Addendum
m
Cleaning Dispenser Nozzles

Nozzle

Collar

Dispenser

Hinge Lever
pins

Collar Release
button

Slots Base Detail, Release button

plate

Figure 1: Remove Dispenser

penser and inspect Nozzle

5. Moisten a cotton swab with sterile water, and clean the

outside of the nozzle and surrounding collar.
6. Inspect the nozzle tip for obstruction. If an obstruction is
present, remove it with a nylon
ylon stylet. Place a 50 mL con-
tainer under the nozzle, perform a flush, and observe
bserve the
stream of liquid for consistency.
WARNING: Keep hands and container away way from
pipettor to avoid injury. After selecting F2
2 - PER-
! FORM MAINT to execute the Prime/Flush
me/Flush for Bulk
Solution 1 or 3 (as required),
), the Processing Pipet-
tor moves.

For details on the flushing procedure, refer to Section 9:

Service and Maintenance, Subsection: Weekly y Mainte-
nance.
7. Reinstall the Bulk Solution 1 Dispenser. Slide the metal
hinge pins on the right end of the Dispenser fullyy down
into the slots of the unlocked lever.
8. Lower the collar on the Dispenser into the circular open-
ing
g of the base plate.

4 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk Solution Dispensers Addendum
m Weekly Maintenance
intenance
Cleaning Dispenser Nozzles

9. Ensure there are no obstructions

ctions between the lever and the
Dispenser.
10. Close the lever to lock the dispenser into position.

Lever

Release
Base button
Hinge
pin plate

Figure
gure 2: Dispenser Lever in the locked position.

11. Perform
form steps 3-10 for Bulk Solution 3 Dispenser.
12. Ensure the
he Dispensers are securely installed and properly
positioned.
CAUTION: Correct installation of the Bulk Solu-
! tions Dispensers is required
quired for the proper dis-
pensing of solutions. Assay results can be
adversely affected by improper dispensing of
Solutions 1 and 3.

• Ensure the lever is in the locked position.

• Ensure the Dispenser can not be lifted
fted up and out of
the base plate and lever.
• Ensure the shaded areas of the labels on top of the
Dispensers line up with each other.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 5

69970-101—June 2002
Weekly Maintenance Bulk
k Solution Dispensers
ensers Addendum
Cleaning Dispenser Nozzles

3
1
Figure 3: Line up shaded areas of labels

13. Close the Processing Center Cover.

14. Install the Matrix
x Cell Hopper.

6 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination

Section 9. Decontamination

This section includes information about the Monthly Mainte-

nance/Decontamination procedure, Tubing g Decontamina-
tion, on the AxSYM System.

Tubing Decontamination
contamination – 5%
% Dilution Procedure
rocedure
Perform the Tubing Decontamination procedure monthly. y. It is
recommended that Bulk Solutions 3 and 4 bottles be replaced
placed
after the Decontamination procedure.

Whenever decontamination procedures are performed, record

them in the AxSYM
SYM Maintenance Log.

WARNING: G: Potential Biohazards. For more

! information refer to Section 8: Hazards, Subsec-
tion: Procedural Hazards.

CAUTION: Potential assay impact. For more

! details, refer to Section 8: Hazards, Subsection:
Procedural Hazards.

Materials Required
• AxSYM System Tubing ng Decontamination Solution
• Approved water
Select one:
– Sterile water
– Water for irrigation
– Type 2 water (Deionized water)
• 500 mL Beakers (3)
• 2 Tubing Decontamination
tamination Bottles
• 50 mL graduated cylinder
• Cotton Swabsbs
• Squirt Bottle
• No. 2 Phillips head screwdriver
ver
WARNING: Wear eye/face protection, gloves and
! lab coat when handling the AxSYM System Tub-
ing Decontamination
amination Solution. Contact with the
eyes could result in permanent injury; avoid con-
tact with skin.
kin. In case of contact with skin or eyes,
flush with copious amounts of water. Seek imme-
diate medical attention.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 7

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing Decontamination – 5% Dilution Procedure

Procedure

Preparation and Decontamination

mination
This procedure requires opening the Processing Center Cover
and the Sampling Pipettor Cover.

NOTE: Instructions for opening the Processing

Center Cover are provided in the Abbott AxSYM
Training Program. Contact thee Abbott Customer
Support Center.

CAUTION: Wait for the Sampling Center motors

! to come to a complete stop before opening the
Sampling Pipettor Cover.

1. Transfer 20 mL of AxSYM
SYM System Tubing Decontamina-
tion Solution into a clean 500
00 mL beaker. Dilute with 380
mL of approved d water which will bring the final volume to
approximately 40000 mL. Mix by stirring.
NOTE: Use diluted AxSYM
YM Tubing Decontamina-
tion Solution immediately.

2. Empty the Liquid Waste Container and update Liquid

Waste inventory.
ventory.
For more details, refer to Section
ion 9: Service and Mainte-
nance, Subsection: Daily Maintenance.
3. Select MAINTENANCE
NTENANCE from the Main Menu screen.

8 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination
Tubing
g Decontamination – 5% Dilution Procedure

4. Select TUBING
UBING DECONTAMINATION.
Follow the
he instructions on the Tubing Decontamination
screen.

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination

Remove Bulk Solution 3 bottle from platform.

Place container with Tubing Decontamination
Solution on platform 3. Place tubing
from bulk solutions 3 and 4 into container.

Select OK to continue
OK CANCEL

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 4: Tubing Decontamination

tamination Screen

5. Select OK to continue.
NOTE: Do not flush AxSYM System Tubing
Decontamination
contamination Solution through Bulk
Solution 1 (MUP) tubing.
bing.

The system performs a ten minute Tubing Decontamina-

tion incubation.
NOTE: Discard any unused diluted Tubing Decon-
tamination Solution.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 9

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing Decontamination – 5% Dilution Procedure

Rinse and Water Flush

1. When the ten-minute Tubing Decontamination incuba-
tion is complete, follow the instructions
ructions displayed on the
Tubing Decontamination Rinse screen.
NOTE: Be sure to thoroughly rinse the outside of
Bulk Solution 3 and Bulk Solution 4 tubing.
bing.

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination/Rinse

Replace container of Tubing Decontamination Solution

on platform 3 with a clean empty 500 ml beaker.
Place Bulk Solutions 3 and 4 tubing into beaker and
rinse outside of tubing thoroughly with approved
water.
Select OK to continue
OK

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 5: Tubing Decontamination/Rinse Screen

10 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination
Tubing Decontamination – 5% Dilution Procedure

Solution 4
Line Diluent

4
1 2 3
4

Figure 6: Rinse excess AxSYM System Tubing

Decontamination
ontamination Solution from tubing

2. Select OK to continue.
3. Follow instructions displayed on the Tubing
bing Decontami-
nation/Water Flush screen.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 11

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing Decontamination – 5%
% Dilution Procedure

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination/Water Flush

Remove beaker with rinse solution from platform.

Place Bulk Solution tubing 3 and 4 into a container
of 500 ml approved water.

Select OK to continue

OK

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 7: Tubing Decontamination/Water

Water Flush Screen

4. Select OK to continue.
The system
ystem flushes the Bulk Solution Tubing with
approved
ved water.

Wash Station Rinse

1. Remove the Matrix Cell Hopper.
2. Open the Sampling Pipettor Cover and the Processing
Center Cover.
3. Follow
w the instructions on the Tubing Decontamination/
Wash Station Rinse screen.
NOTE: Be sure to thoroughly rinse the entire
wash cup and channel.

12 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination
Tubing Decontamination – 5% Dilution Procedure

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination/Wash Station Rinse

Remove Sampling and Processing Wash Stations.

Rinse each Wash Station with at least 50 ml of
approved water. Reinstall Wash Stations.

Select OK to continue

OK

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 8: Tubing Decontamination/Wash Station Rinse

Screen

For more details on removing the

he wash stations, refer to
Section 9: Service and Maintenance, Subsection:
section: Com-
ponent Replacement.
4. Select OK to continue.
5. Close the Sampling
pling Pipettor Cover.

Clean Dispenser Nozzle

1. Follow the instructions on the Tubing Decontamination/
amination/
Nozzle Cleaning screen.
NOTE: For more detail on cleaning the Dispenser
penser
Nozzle, refer to Weekly Maintenance, Cleaning
Dispenser Nozzles in this addendum (Bulk Solu-
tion Dispensers Addendum).

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 13

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing
g Decontamination – 5% Dilution Procedure

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination/Nozzle Cleaning

Remove Bulk Solution 3 Dispenser. Clean the nozzle

and surrounding collar with a cotton swab moistened
with approved water. Reinstall the dispenser and
position correctly.

Select OK to continue

OK

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 9: Tubing
ubing Decontamination/Nozzle Cleaning Screen

Nozzle

Collar

Dispenser

Hinge Lever
pins

Collar Release
button

Slots Base Detail, Release button

plate

Figure 10: Remove

ve Dispenser and Clean Nozzle and Collar

14 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination
Tubing Decontamination – 5% Dilution Procedure

Lever

Release
Base button
Hinge
pin plate

Figure 11: Reinstalled Dispenser with

h Lever correctly locked

3
1
Figure 12: Shaded areas of labels positioned correctly

When the dispensers are properly positioned, the lever is in

the locked position and the shaded areas of the labels (on top
of the Bulk Solution Dispensers) line up with each other.

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 15

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing Decontamination – 5%
% Dilution Procedure

CAUTION: Correct installation of the Bulk Solu-

! tion Dispensers
pensers is required for the proper dispens-
ing of solutions. Assay results can be adversely
affected by improper
mproper dispensing of Solutions 1
and 3.

2. Close the Processing Center Cover.

3. Replace the Matrix Cell Hopper.
4. Select OK to continue.

Bulk Solution
tion Flush
1. Follow the instructions on the Tubing Decontamination/
Bulk Solution Flush screen.
2. Replace
place with new Bulk Solutions, if desired.
CAUTION: Potential assay impact.
mpact. For informa-
! tion on loading Bulk Solutions refer to Section
on 8:
Hazards
ds, Subsection: Procedural Hazards.

For more details on loading Bulk Solutions, refer to Sec-

tion 5: Operating Instructions, Subsection: Inventory
and Loading Consumables.
Consumables

Status: MAINT 07/08/94 09:31

ADMIN
Main Menu/Maintenance

Tubing Decontamination/Bulk Solution Flush

Remove Bulk Solution tubing from approved water
container and remove container from platform. Load
Bulk Solution 3 bottle on appropriate platform.
Insert tubing in appropriate containers.

Select OK to continue

OK

Select the desired function.

EXIT
F1 F2 F3 F4 F5 F6

Figure 13: Tubing Decontamination/Bulk Solution Flush

h
Screen

16
6 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum
69970-101—June 2002
Bulk
k Solution Dispensers
ensers Addendum Decontamination
ontamination
Tubing Decontamination – 5% Dilution Procedure

3. Select OK
K to continue.
The system flushes the Bulk Solution Tubing with Bulk
Solutions.
4. Wait for Bulk Solution Tubing Decontamination Proce-
dure to complete.
5. Empty the Liquid
quid Waste Container.
6. Select OK to exit to Maintenance screen.
7. Update Bulk Solution and Liquid Waste Inventory.
For more details on unloading waste and updating inven-
tory, refer to Section 9: Service and Maintenance, Sub-
section: Daily Maintenance.
8. Return to Main Menu (optional).
Choose one:
• Press Main Menu keyy
• Touch Abbott “A” logo

ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum 17

69970-101—June 2002
Decontamination Bulk
lk Solution Dispensers
ensers Addendum
Tubing Decontamination – 5%
% Dilution Procedure

NOTES

18 ABBOTT AxSYM® SYSTEM Bulk Solution Dispensers Addendum

69970-101—June 2002