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Operation, Installation and Service Manual
Operation, Installation and Service Manual
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Operation, Installation and r
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Service Manual t
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RFID Contrast Identification Accessory for t
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MEDRAD® Stellant CT Injection System s
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with Certegra™ Workstation p
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Operation, Installation and Service Manual i
1 Introduction ......................................................................................1
1.1 Intended Use.................................................................................................................................................... 1
1.2 Certifications.................................................................................................................................................... 1
1.3 Contraindications ........................................................................................................................................... 2
1.4 Required Training ........................................................................................................................................... 2
1.5 Symbols............................................................................................................................................................. 2
1.6 Definition of Terms ........................................................................................................................................ 3
1.7 System Configuration.................................................................................................................................... 3
C Installation......................................................................................23
C.1 Tools Required...............................................................................................................................................23
C.2 Installation.....................................................................................................................................................23
C.3 Configuring CWS for the RFID Reader ....................................................................................................26
C.4 System Setup .................................................................................................................................................27
F Dimensions ......................................................................................35
G Environmental Specifications ........................................................37
G.1 Operating .......................................................................................................................................................37
G.2 Non-operating (Transportation and Storage).......................................................................................37
G.3 Wireless Communication ...........................................................................................................................37
1 Introduction
This document provides instructions on how to use the radio frequency identification (RFID) Contrast Identification
Accessory (RFID Reader) for the MEDRAD® Stellant with Certegra™ Workstation (CWS). The RFID Reader is only to be
used with the MEDRAD Stellant with CWS.
Use the RFID Reader to read the RFID tags on prefilled cartridges (CT - PFC) containing CT contrast media. The
associated data (product name, concentration, volume, expiration date, lot/batch number) will be automatically
transferred and displayed on the CWS Informatics panel.
CAUTION
Manually enter the proper Pressure Limit in order to avoid component damage and potential operator/
patient injury. The RFID Reader does not read or transfer pressure limit from the RFID tag to the CWS.
NOTE: Bayer has certified RFID reading of prefilled CT cartridges for Iopamiron (Bayer), Omnipaque
(Daiichi-Sankyo), and Iomeron (Eisai). Other contrast brands that may contain RFID tags are not
certified to work with the current solution.
1.2 Certifications
The RFID Reader complies with IEC 60950-1 and Japan Radio Law. The RFID Reader is an approved accessory to the
MEDRAD Stellant with CWS, which complies with IEC 60601-1.
The RFID Reader complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause undesired
operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
QConnect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
QConsult the dealer or an experienced radio/TV technician for help.
1-2 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation
1.3 Contraindications
None known.
1.5 Symbols
Laser Light
Do not stare into beam
Class 2 Laser Product
MR-Unsafe: These are products which must not be used in an MRI environment.
Indicates separate collection for Electrical and Electronic Equipment per Directive
2002/96/EC. Refer to the following website for additional information:
www.weee.bayer.com
NOTE: Indicates that the information that follows is additional important information or a tip that will
help the user to recover from an error or point to related information within the manual.
Charging Pins
Pairing Barcode
Unpair Button
Primary Button
Charging Contacts
When reading qualified RFID tags, the RFID Reader will capture the following contrast information:
Q Product Name
Q Concentration
Q Volume
Q Expiration Date
Q Lot/Batch Number
CAUTION
Manually enter the proper Pressure Limit in order to avoid component damage and potential operator/
patient injury. The RFID Reader does not read or transfer pressure limit from the RFID tag to the CWS.
Figure 1 - 3: Press “Fluids” to Review RFID Tag Information (see Figure 1-4)
NOTE: It is recommended that whenever the RFID Reader is not being used, it is placed in its Charging
Base to maintain its battery charge.
NOTE: If the RFID Reader is not active, refer to subsections 3.2 and 3.3.
2. Hold the RFID tag for the disposable prefilled CT cartridge in front of the RFID Reader.
The device will emit an audible high-pitched beep and the green LED will flash. When the green LED
flashes again and a second beep occurs, the RFID Reader has successfully transferred the fluid information
to the CWS.
3. Check the Informatics panel on the CWS to confirm that the correct fluid information is displayed.
NOTE: If the RFID Reader remains inactive for more than one minute, it will enter Sleep mode (green LED
off). If this happens, press and release the primary button on the RFID Reader to activate it (wait
to see that green LED is on). The RFID Reader will emit an audible ticking sound as it attempts to
reconnect to the Charging Base, followed by three ascending beeps to indicate the connection is
complete.
2. Hold the device next to the RFID tag of the disposable prefilled CT cartridge.
Important! Do not press the primary button on the RFID Reader while reading an RFID tag if the
green LED is on. This action turns off the RFID reader and activates the laser.
The RFID Reader will emit a high-pitched beep and the green LED will flash. If this does not occur, hold the
front of the RFID Reader against the RFID tag until it reads the data from the prefilled CT cartridge.
When the green LED flashes again and a second beep occurs, the RFID Reader has successfully transferred
the fluid information to the CWS.
NOTE: If the RFID Reader is out of range of the Charging Base, it cannot transfer the fluid data to the
CWS. The RFID Reader will emit an audible ticking sound, which will continue until the RFID
Reader is within range (ticking sound is limited to one minute).
NOTE: If the RFID does not read the RFID tag on the prefilled CT cartridge, check to see if the system is
engaged in arming, holding, or injecting. If it is, the reading cannot be done until the activity is
complete.
NOTE: When the RFID Reader is out of the Charging Base, it can hold a charge for four hours.
2 - 10 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation
Operation, Installation and Service Manual 3 - 11
NOTE: If the RFID Reader’s red LED is flashing, it indicates that the battery is low.
3 - 12 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation
NOTE: The RFID reader must be active (green LED on) to read a tag.
Q If the RFID Reader responds with ticking following by the three ascending beeps, the RFID Reader is paired
with that base.
Q If the RFID Reader responds with repeated ticking followed by a low beep and a red LED flash, the RFID
Reader is not paired with the base.
NOTE: The RFID Reader uses wireless communication technology to communicate with its Charging
Base. The RFID Reader will be paired with its Charging Base as part of the CWS installation and
configuration.
2. Press and hold the RFID Reader’s primary button to turn on the barcode laser and scan the pairing barcode
located inside the Charging Base. The barcode laser will turn off when the pairing barcode is read. The
device will emit a ticking sound. This indicates that the pairing process has started.
3. When the pairing process is complete, three ascending beeps occur. The RFID Reader can now be used with
the paired Charging Base for the associated CWS.
NOTE: It is not recommended to unpair an RFID Reader device from its Charging Base, as this will disable
the functionality of the RFID Reader.
General
Red/Green
Power up -
Flash once
Green
Successful connection to Charging Base Three ascending beeps
Flash once
Red
Unsuccessful connection to Charging Base Long low beep
Flash once
Red/Green
Charging and ready to read RFID tag -
Flash multiple times
Red
Battery low -
Flash multiple times
RFID Reading
Green
Successful RFID read Short high beep
Flash once
Green
Successful fluid information display on CWS Long high beep
Flash once
Wireless Connection
Establishing wireless connection to base Ticking repeating every 0.5 second -
Red
Unsuccessful wireless connection Long low beep
Flash once
A - 18 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation
Base Pairing
Establishing wireless connection to base Ticking repeating every 0.5 second -
Red
Unsuccessful Charging Base Pairing Long low beep
Flash Once
Operation, Installation and Service Manual B - 19
NOTE: Be sure to only charge the RFID Reader with the provided RFID Charging Base. In addition, do not
use the provided RFID Charging Base to charge any other device.
NOTE: A flashing red LED on the RFID Reader indicates a low battery. Place the RFID Reader in the USB-
connected Charging Base to re-charge. While charging and ready to scan, the RFID Reader’s red
and green LEDs flash alternately. When charging is complete, the RFID Reader’s green LED stays
lit.
Installation and Service of RFID Reader
Operation, Installation and Service Manual C - 23
C Installation
C.1 Tools Required
Q #2 Phillips head screwdriver
C.2 Installation
1. The following instructions describe mounting the RFID Reader bracket on the right-hand side of the
workstation. If it is desired to mount the assembly on the left-hand side of the workstation, disassemble
the bracket by removing the two screws. This will separate the L-bracket component from the V-bracket
component. Turn the L-bracket component over to mount on the right-hand side of the V-bracket
component. Insert the two screws and tighten. This will permit mounting the bracket on the left-hand side
of the workstation.
2. Loosen the two Charging Base mounting pin screws from the rear of the bracket.
Charging Base
Mounting Pins
4. Push the Charging Base down toward the front of the bracket until it snaps into place. The front edge of
the Charging Base should be even with the edge of the bracket.
Slot
7. Align the mounting pins vertically so that they will slide into the slot. Position the bracket and Charging
Base at a desired height on the side of the display.
Screws
12. When the base is connected, place the RFID Reader into the base to charge the battery.
NOTE: If the RFID Reader responds with continued ticking and ending with a low beep tone and red LED
flash, the RFID Reader may not be properly paired with the base. See Section 3.7.1 for pairing
instructions.
3. With the battery fully charged the green LED should be illuminated. Up to four hours may be required to
fully charge the battery.
4. Place an RFID tag in front of the RFID Reader. (This may be performed while the unit is charging.)
5. There will be a high-pitched beep and the green LED will flash. When the green LED flashes again and a
second beep occurs, the RFID Reader has successfully transferred the fluid information to the CWS.
6. Check the Informatics panel FLUIDS section on the CWS to ensure the correct fluid information is displayed.
C - 28 RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation
Operation, Installation and Service Manual D - 29
CAUTIONS
Q Battery replacement should only be performed by qualified personnel such as Bayer Service Personnel or
system owner biomedical engineers/technicians. Improper replacement may result in property damage
or personal injury.
Q Do not disassemble the battery. There are no user-serviceable parts in the battery.
Q Do not short-circuit a battery or throw it into a fire. It can explode and cause severe personal injury.
Screws
Connector
4. Disconnect the battery from the printed circuit board by prying the connector from its socket using a small
screwdriver, as shown in the next photo.
Figure D - 4: Battery with and without Poron pads (pads shown in center photo)
Operation, Installation and Service Manual D - 31
7. Insert the battery installation fixture into the unit so it is sitting on the top side of the board where the
internal Poron pads are located.
NOTE: When properly connected, the red wire will face to the right, as shown in Figure D-6.
12. Attach a piece of anti-static Kapton tape (provided) over the wires and Poron pads on the battery
installation fixture. If no tape is provided, reuse that tape previously removed.
F Dimensions
5.53 in
14.04 cm
2.00 in 1.28 in
5.07 cm 3.26 cm
5.81 in
14.75 cm
2.37 in 2.19 in
6.03 cm 5.55 cm
5.81 in
14.75 cm
2.37 in 2.19 in
6.03 cm 5.55 cm
G Environmental Specifications
G.1 Operating
Temperature: 10 to 40 degrees C (inclusive)
Humidity: 20 to 90 percent (inclusive), non-condensing
Air Pressure: 69 to 105 kPa (inclusive)
Bayer reserves the right to modify the specifications and features described herein or to discontinue any product or service
identified in this publication at any time without prior notice or obligation. Please contact your authorized representative from
Bayer for the most current information.
All patient data that appear in this document are fictitious. No actual patient information is shown.
Bayer, the Bayer Cross, MEDRAD, Stellant, MEDRAD Stellant and Certegra are trademarks owned by and/or registered to Bayer in
the U.S. and/or other countries. Other trademarks and company names mentioned herein are properties of their respective owners
and are used herein solely for informational purposes. No relationship or endorsement should be inferred or implied.
© 2015-2017 Bayer. This material may not be reproduced, displayed, modified or distributed without the express prior written
consent of Bayer.