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CERUS INTERCEPT INT100 User manual

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INTERCEPT
®
Blood System
Pathogen Inactivation Process
ILLUMINATOR
Operator Manual
Software Version 6
Cerus Corporation Cerus Europe B.V.
2550 Stanwell Drive Stationsstraat 79-D
Concord, CA 94520 USA 3811 MH Amersfoort
Made in USA The Netherlands
www.interceptbloodsystem.com
Cerus and INTERCEPT are trademarks of Cerus Corporation.
MAN-EN 00601, v3.0
INTERCEPT
ILLUMINATOR
INT100
Operator Manual
Software Version 6
Illuminator Serial Number_________________
MAN-EN 00601, v3.0
This page intentionally left blank.
MAN-EN 00601, v3.0
Master Table of Contents
i
Master Table of Contents
(Each Chapter has a Detailed Table of Contents)
CHAPTERS PAGE
1. What the Illuminator Does 1-1
2. How to Use this Manual 2-1
3. Illuminator Description 3-1
4. How to Use the Illuminator 4-1
5. Troubleshooting 5-1
6. Maintenance, Transportation and Storage, 6-1
Warranty and Service
7. Specifications 7-1
8. Appendix 8-1
MAN-EN 00601, v3.0
Master Table of Contents
ii
This page intentionally left blank.
MAN-EN 00601, v3.0
Chapter 1 – What the Illuminator Does
1-1
Chapter 1 What the Illuminator Does
SECTIONS PAGE
1.1 What the Illuminator Does 1-3
1.2 Intended Use of the Illuminator 1-4
1.3 Indications for Use 1-5
1.4 Contraindications for Use 1-6
1.5 Notes to Transfusionists 1-7
1.6 Warnings 1-8
1.7 Cautions 1-11
MAN-EN 00601, v3.0
Chapter 1 – What the Illuminator Does
1-2
This page intentionally left blank.
MAN-EN 00601, v3.0
Chapter 1 – What the Illuminator Does
Section 1.1 – What the Illuminator Does
1-3
Section 1.1 What the Illuminator Does
The INTERCEPT Illuminator delivers a controlled dose of Ultraviolet A (UVA)
light to blood products, as part of the process to inactivate pathogens. The
illuminator is used in conjunction with platelets and plasma in an INTERCEPT
Processing Set. The processing set allows blood products to be handled in a
closed system. The illuminator maintains records of blood products, processes
and transfers these records to a printer or computer.

NOTE:
The operator is protected from the UVA source during normal
illuminator operation per EN 61010-1.
Each blood product uses a specific processing set. It is important to use the
correct processing set and use sets approved by your local regulatory authority.
A brief overview of the pathogen inactivation process is detailed below:
•The blood product is prepared in accordance with approved specifications for
processing with INTERCEPT. Refer to the Instructions for Use provided with
the processing sets for treatment specifications.
•The blood product is then mixed with amotosalen HCl.
•The amotosalen interacts with DNA or RNA in virus, bacteria, parasites or
leukocytes if they are present in the blood product.
•When the blood product with amotosalen is exposed to UVA light, the
amotosalen “crosslinks” the DNA or RNA. Pathogens can be prevented from
replicating by this process.
•Residual amotosalen is reduced by adsorption prior to storage.
MAN-EN 00601, v3.0
Chapter 1 – What the Illuminator Does
Section 1.2 – Intended Use of the Illuminator
1-4
Section 1.2 Intended Use of the Illuminator
The ‘illuminator’ refers to the INT100 INTERCEPT Illuminator. The
INTERCEPT Illuminator is intended only for use in the pathogen inactivation
process to deliver UVA light for the photochemical treatment of blood products.
The illuminator should be used only by personnel trained to perform the
INTERCEPT Blood System process.

NOTE:
Only INTERCEPT Blood System disposable processing sets can be
used with the INT100 INTERCEPT Illuminator.
MAN-EN 00601, v3.0