CERUS INTERCEPT INT100 User manual

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_________________
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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
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Master Table of Contents
ii
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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
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Chapter 1 – What the Illuminator Does
1-2
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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.
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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.
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Chapter 1 – What the Illuminator Does
Section 1.3 – Indications for Use
1-5
Section 1.3 Indications for Use
Platelets and plasma treated with the INTERCEPT Blood System process are
indicated for support of patients requiring transfusions, according to clinical
practice guidelines.
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Chapter 1 – What the Illuminator Does
Section 1.4 – Contraindications for Use
1-6
Section 1.4 Contraindications for Use
Use of platelets and / or plasma treated with the INTERCEPT Blood System
process is contraindicated in patients with a history of allergic response to
amotosalen or psoralens.
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Chapter 1 – What the Illuminator Does
Section 1.5 – Notes to Transfusionists
1-7
Section 1.5 Notes to Transfusionists
While laboratory studies of amotosalen processing with UVA light have shown a
reduction in levels of certain viruses and bacteria, there is no pathogen
inactivation process that has been shown to eliminate all pathogens.
INTERCEPT platelets or plasma components should not be prescribed to
neonatal patients treated with phototherapy devices that emit a peak energy
wavelength less than 425 nm, and/or have a lower bound of the emission
bandwidth <375 nm, due to the risk of erythema resulting from potential
interaction between ultraviolet light (below 400 nm) and residual amotosalen.
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Chapter 1 – What the Illuminator Does
Section 1.6 – Warnings
1-8
Section 1.6 Warnings
The warning messages below will alert you to potential hazards that may cause
personal injury. This includes conditions that would compromise pathogen
inactivation results.
Warning messages are listed according to the Section in which they appear.
Chapter 3: ILLUMINATOR DESCRIPTION

WARNING
If the blood product leaks into the tray, tilting the drawer
could cause the blood product to spill out. If the tray is above
the operator’s eye level, the operator should wear eye
protection when tilting the drawer.
Section 3.5 - Illumination Door and Drawer

WARNING
Amotosalen in contact with skin may result in
photosensitization in the presence of ultraviolet light. If skin
exposure occurs, flush exposed skin copiously with water.
Section 3.5 - Illumination Door and Drawer

WARNING
The side access panel should only be opened by a qualified
field service engineer. There are no user serviceable parts
accessible by the side access panel.
Section 3.9 - Features for Safety and Function
Chapter 4: HOW TO USE THE ILLUMINATOR

WARNING
All materials containing platelets or plasma (including
tubing) must be placed within the large compartment of the
illuminator tray for adequate treatment to occur. The
INTERCEPT Blood System is validated with unimpeded
light transmission through the tray and the illumination
container with the blood component. No labels or other
material should be on this area. Labels should be placed on
the illumination container flap only. The tray must be clean.
The illumination container should not be folded.
Section 4.3 - Load Processing Set(s)

WARNING
The tubing containing the blood product mixed with
amotosalen must be held within the left-hand side of the
chamber where illumination occurs. Platelet or plasma
product in the tubing which is not entirely within the area
receiving illumination will not be pathogen inactivated.
Section 4.3 - Load Processing Set(s)
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Chapter 1 – What the Illuminator Does
Section 1.6 – Warnings
1-9

WARNING
Make sure the barcodes and chamber position of each
container are correctly entered into the illuminator.
Section 4.4 - Scan Barcodes

WARNING
Partial illumination has not been validated for pathogen
inactivation. Do not attempt to re-treat a partially treated
unit. Do not treat a blood product more than once. No claim
of pathogen inactivation can be supported for partially
illuminated units and they should be discarded.
Section 4.7 - Illumination Interruption
Section 4.8 - Unload the Processing Set(s)
Chapter 6: MAINTENANCE, TRANSPORTATION AND STORAGE,
WARRANTY AND SERVICE

WARNING
Lifting or carrying the illuminator should be done by a
minimum of two people or by using a mechanical lifting
device.
Section 6.2 - Selecting a Place for the Illuminator
Section 6.4 - Transportation and Storage

WARNING
Do not stack illuminators more than two-high.
Section 6.2 - Selecting a Place for the Illuminator

WARNING
Turn off the illuminator and disconnect the power source
before performing any maintenance on the illuminator.
Section 6.3 - Cleaning the Illuminator

WARNING
Blood products containing amotosalen should be treated like
all other blood products, that is, as biohazardous material.
Follow the guidelines for use of protective equipment,
cleaning and disposal, as laid out in your facility.
Section 6.3 - Cleaning the Illuminator

WARNING
If the blood product leaks into the tray, tilting the drawer
could cause the blood product to spill out. If the tray is above
the operator’s eye level, the operator should wear eye
protection when tilting the drawer.
Section 6.2 - Selecting a Place for the Illuminator
Section 6.3 - Cleaning the Illuminator
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Chapter 1 – What the Illuminator Does
Section 1.6 – Warnings
1-10
Chapter 7: SPECIFICATIONS

WARNING
The use of accessories and cables other than those specified
in this manual, as replacement parts for internal
components, may result in increased emissions or decreased
immunity of the illuminators.
Section 7.2 - Illuminator Compliance with Standards

WARNING
The illuminators should not be used adjacent to or stacked
with other manufacturer’s equipment. If adjacent or stacked
use is necessary, the illuminators should be observed to
verify normal operation in the configuration in which it will
be used.
Section 7.2 - Illuminator Compliance with Standards

WARNING
The pins of connectors identified with the ESD warning
symbol should not be touched and connections should not be
made to these connectors unless ESD precautionary
procedures are used.
Precautionary procedures include:
•methods to prevent build-up of electrostatic charge
(e.g. air conditioning, humidification, conductive
floor coverings, non-synthetic clothing);
•discharging one’s body to the frame of the
EQUIPMENT or SYSTEM or to earth or a large
metal object;
•bonding oneself by means of a wrist strap to the
EQUIPMENT or SYSTEM or to earth.
Section 7.2 - Illuminator Compliance with Standards

WARNING
The illuminator must be attached to the mains and grounded
to comply with appropriate standards.
Section 7.3 - Illuminator Requirements
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Chapter 1 – What the Illuminator Does
Section 1.7 – Cautions
1-11
Section 1.7 Cautions
The cautions below alert you to any conditions that could affect the blood
product quality, damage the illuminator, or make the illuminator sound an alarm
unnecessarily.
Cautions are listed according to the Section in which they appear.
Chapter 3: ILLUMINATOR DESCRIPTION
!
CAUTION
If any part of the illuminator tray is damaged (cracked, scratched
or cloudy) contact your authorized service representative for a
replacement. Do not use the illuminator if the tray is damaged.
Section 3.5 – Illumination Door and Drawer
!
CAUTION
Do not change date or time while units are in the illuminator.
Section 3.6 – Illuminator Settings
!
CAUTION
Illumination labels are not suitable for freezing and thawing.
Section 3.6 – Illuminator Settings
!
CAUTION
Once an account has been disabled, it cannot be reactivated.
Furthermore, the username cannot be reused.
Chapter 4: HOW TO USE THE ILLUMINATOR
!
CAUTION
Use care not to block the air vents of the illuminator during
operation. Paper set near the air filter may be pulled against the
filter by the fan and block airflow.
Section 4.2 - Turn On the Illuminator and Enter Credentials
!
CAUTION
Make sure all tubings are in the tray before closing the cover and
drawer.
Section 4.5 - Repeat Set Loading for Container 2
!
CAUTION
Illumination should not be interrupted, unless it is absolutely
essential. It will result in improperly treated blood product(s) that
should be discarded.
Section 4.7 - Illumination Interruption
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Chapter 1 – What the Illuminator Does
Section 1.7 – Cautions
1-12
Chapter 6: MAINTENANCE, TRANSPORTATION AND STORAGE,
WARRANTY AND SERVICE
!
CAUTION
Do not use the illuminator if there is condensation on it.
Humidity higher than 80% may shorten the life of instrument
components.
Section 6.2 - Selecting a Place for the Illuminator
!
CAUTION
Use only approved solutions to clean and disinfect the tray;
otherwise, damage may occur.
Section 6.3 - Cleaning the Illuminator
!
CAUTION
If any part of the illuminator tray is damaged (cracked, scratched
or cloudy) contact your authorized service representative for a
replacement. Do not use the illuminator if the tray is damaged.
Section 6.3 - Cleaning the Illuminator
Chapter 7: SPECIFICATIONS
!
CAUTION
The illuminators need special precautions regarding
electromagnetic compliance (EMC) and need to be installed and
put into service according to the EMC information provided in
the above tables.
Section 7.2 - Illuminator Compliance with Standards
!
CAUTION
Portable and mobile radio frequency (RF) communications
equipment can affect the illuminators by interfering with the
electronics, causing the illumination to stop.
Section 7.2 - Illuminator Compliance with Standards
!
CAUTION
If the fuse blows after bulb replacement, the illuminator should
not be used. Contact your authorized service representative for
assistance.
Section 7.3 - Illuminator Requirements
!
CAUTION
If using Codabar (excluding Monarch 11 and UKBTS), the
illuminator will not evaluate the integrity of the scanned data.
Verify the data scanned matches the information displayed on
the illuminator screen.
Section 7.4 - Barcode Compatibility
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Chapter 2 – How to Use this Manual
2-1
Chapter 2 How to Use this Manual
SECTIONS PAGE
2.1 Getting Started 2-3
2.2 Symbols 2-5
2.3 Conventions Used in this Manual 2-9
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Chapter 2 – How to Use this Manual
Section 2.1 – Getting Started
2-2
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