ENGINEERING CHANGE RECORD

No: 313B059
TITLE: Changing product specifications
Included ECR No:
PRIORITY: Information only
DATE RELEASED: April 22, 2013
MODEL: XP-100, XP-300

Revision Information:
N/A

Applicable To:
This change will be applied to instruments assembled in May 2013 and thereafter.

The serial number information will be provided in ECR revision when confirmed.

Summary:
The XP Series product specifications have been changed.

Detailed Information:
To comply with FDA requirements, XP Series product specifications have been
changed. As a result, the XP Series Service Manual Chapter 1: Specifications
have been updated.
Please see below for changed information.

Revised Revised section Changed contents

page
1-2 1.5.1 (3) Control Control blood "EIGHTCHECK 3WP
blood and X-TRA" has been added for North
Calibrator American markets.
1-5 1.6.1 Intended Use The following note has been added, as
EDTA-2Na is not used in North
American markets.

"Note: EDTA-2Na is not intended for

North American markets."
1-6 1.6.2.2 Analysis Table "Reportable Range" has been
and Display Range added.

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 1-8 1.6.2.4 Accuracy To separate specifications for North
American markets from those for other
markets, tables and descriptions for
North American markets have been
added.
1-10 1.6.2.7 Stability A table and descriptions have been
(3) Day-to-Day added for North American markets.
Stability
1-11 1.6.2.7 Stability Item (5) "Sample Day-to-Day
(5) Stability" has been added for North
American markets.
1-12 1.6.2.10 Influence Item 1.6.2.10 "Influence by inhibitor"
by inhibitor (for has been added for North American
North American markets.
markets only)

Action To Be Taken :
1. Please refer to the following pages of updated SYSMEX
documentation (attached) for applicable information.
2. These updated pages will be included in the next Manual update.
XP Series Service Manual pages: 1-2, 1-5, 1-6, 1-8, 1-10 ~ 1-12

Parts Quantity Changes:

None

Reference Document :
None

Attachments :
XP Series Service Manual Chapter 1 Specifications

Person in
Chieko Takeda
Charge:
Reviewed by: Junko Horitaka, Mark Dorfner
Authorized by: Atsumasa Sone

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