July 2011

Dear Valued ACL ELITE/ELITE PRO Customer,

Instrumentation Laboratory is pleased to release a new Test Library (version 02.01.00) to

address the test group issue for your ACL ELITE and ELITE PRO. This new library release can
be installed by the user on ACL ELITE or ELITE PRO units currently at software version 3.01.04
and test library version 02.00.00 or higher. Prior to performing the upgrade it is important to read
through this letter to understand the changes included with this release.
In addition to the updated library the upgrade kit also includes a CD containing a pdf version of
the revised ACL ELITE/ELITE PRO Operator’s manual. This version of the manual includes
updates to the maintenance section which are required with this library release.

Implementation of this release is mandatory because it includes refinements to address the

following previously notified regulatory issue:

• Discontinue Use of All PT/APTT-Based IL Locked Test Groups on

ACL ELITE, ACL ELITE PRO, ACL 8000, ACL 9000 and ACL 10000 Coagulation
Analyzers – Dated October 2010

Updates included in this release

• The following test groups have been re-optimized* to improve performance and result
quality
 RPT SYS
 RPT_SYS
 HS+ SP
 HS+_SP
*Optimization includes reorganizing the pipetting sequences for reagents and samples
as well as the introduction of additional probe rinse cycles for the samples and reagents.

The additional probe rinse cycles are also included in the single PT (RecombiPlasTin &
HS+) and APTT (SynthASil & SP) assays along with their respective extended, duplicate
and extended duplicate tests.

• The following test groups have the APTT SynthASil incubation range changed from 210
to 240 seconds**
 HS+SYS
 HS+_SYS
**This change is also included in the single APTT SynthASil test and its respective
extended, duplicate and extended duplicate tests.

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 • The following tests and associated test groups will now require two bottles of Clean A
onboard (one bottle for the sample probe and one for the reagent probe)
 APTT SP, APTT SPe, APTT SPd, APTT SPed
 PT SP (test group)
 PT_SP (test group)

• The following Test Groups have been deleted from the Library either due to reagent
product discontinuation or continued non-optimal performance post optimization.
 HS LYO
 HS_LYO
 HS+ LYO
 HS+_LYO
 HS LYOTT
 HS_LYOTT
 HS SP
 HS_SP
 RPT SP
 RPT_SP

• New material introduced in this release include the following:

Liquid ID: CleaningA2
Liquid Extended Name: Cleaning A2 HCL
Note: This is the liquid ID for the second bottle of Clean A for use with the
APTT SP test and test groups

Maintenance Schedule Optimization

Important…Internal studies have demonstrated superior instrument performance when dilute

Clean B (Hypochlorite) is utilized to clean the probes on a daily basis (or every 75 samples)
instead of Clean A (0.1 N HCL).

The dilute Clean B should be prepared prior to use by diluting 1 part of HemosIL® Cleaning
Agent (PN 0009832700) with 7 parts of distilled water. The recommended daily consumption of
dilute clean B for the cleaning procedure is 0.4 mL for each probe. At this consumption rate
your lab will require 2 additional bottles yearly of HemosIL Cleaning Agent (PN 0009832700) for
probe cleaning performed once per day. Your lab will also utilize 1 less bottle yearly of HemosIL
Cleaning solution (Clean A - PN 0009831704).

The maintenance chapter in the operator’s manual has been updated to reflect the modifications
for the item above. Please ensure you and/or any ACL ELITE/ELITE PRO operators take time
to review these important changes to the maintenance schedule. A CD containing the revised
ACL ELITE/ELITE PRO Operators manual is included in the upgrade package.

Wash-R Consumption with library 2.1

With the introduction of additional rinses for the RecombiPlasTin PT, APTT SP and APTT
SynthASil tests, run in the Single Test, Profile or Test Group mode, you will note an increase
usage of Wash-R and should plan your inventory accordingly. The table included provides
some details on the additional usage you should expect for each run for the respective number
of samples.

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 No. of
Samples 1 3 5 7 10 12 15 20 25 30 35 40
in Run
PT Extra
2.5 3.02 3.54 4.06 4.84 5.36 6.14 7.44 8.74 10.04 11.34 12.64
RecombiPlasTin* Wash-R
mL mL mL mL mL mL mL mL mL mL mL mL
usage/run
APTT SynthASil Extra
1.43 1.92 2.47 2.96 3.77 4.26 5.07 6.37 7.67 8.97 10.27 11.57
or Wash-R
mL mL mL mL mL mL mL mL mL mL mL mL
APTT SP** usage/run

Calculation of extra consumption of Wash-R for each run is based upon the following:

*PT RecombiPlasTin: 2.5 mL for first sample, plus 0.26 mL for each additional sample in the
run
**APTT SynthASil or SP: 1.4mL for first sample, plus 0.26 mL for each additional sample in the
run

Example - On a daily basis you process 51 PT and APTT tests in the following manner:
- 6 PT runs with 5 samples per run (6 runs x 3.54 mL extra Wash-R per run = 21.24 mL per
day)
- 4 PT runs with 1 sample per run (4 runs x 2.5 mL extra Wash-R per run = 10 mL per day)
- 3 APTT runs with 5 samples per run (3 runs x 2.47 mL extra Wash-R per run = 7.41 mL per
day)
- 2 APTT runs with 1 sample per run (2 runs x 1.43 mL extra Wash-R per run = 2.86 mL per
day)

Add up the additional Wash-R usage (21.24 + 10 + 7.41 + 2.86) = 41.51 mL

If this is your typical daily workload and the lab runs this 7 days per week you would need an
extra 16 bottles of Wash-R each year.
(41.51ml per day x 365 days = 15, 151mL/year. Each bottle contains 1000mL therefore divide
the 15,151 by 1000 to arrive at 16 bottles per year.)

Result integrity after upgrade

After performing this library upgrade you will not lose any patient, Quality Control, Analytical
Reference or Calibration data. The APTT SP and PT derived Fibrinogen tests (and their
derivatives..e, d, ed) will be removed from the profiles set up in your system. If you run these
tests you will need to update your profiles (Setup  Multi-Tests  Profiles) after the upgrade.
As per good lab practice it is recommended you run your routine quality control materials prior
to reporting results to ensure quality system performance after executing the upgrade.

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