RFID Contrast Identification Accessory Operation , Installation and Service Manual Rev G Oct 2017

Operation, Installation and Service Manual

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

2 Using the RFID Reader...7 2.1 Conditions for Valid RFID Reading... 7 2.2 In the Charging Base ... 8 2.3 Removed from Charging Base... 9

3 Troubleshooting the RFID Reader...11 3.1 Checking State of CWS ...11 3.2 Checking RFID Reader Connection (in Charging Base) ...11 3.3 Checking RFID Reader (in Charging Base)...11 3.4 Checking RFID Reader (out of Charging Base) ...11 3.5 Determining if RFID Reader is in Sleep mode...12 3.6 Determining if RFID Reader is Out of Range ...12 3.7 Determining if RFID Reader is Paired with the CWS ...12 3.7.1 Pairing the RFID Reader...13 3.7.2 Unpairing the RFID Reader ...15 3.8 Determining if the RFID Tag may be Defective...15

A Audio and Visual Feedback Indicators ...17 B Prerequisites for RFID Reader...19 B.1 Charging the RFID Reader ...20

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

D RFID Reader Battery...29 D.1 Replacing the Battery...29 D.1.1 Tools Required ...29 D.1.2 Replacing the Battery ...29 D.2 Proper Disposal of Battery ...32

E Cleaning the RFID Reader...33 E.1 Cleaning the RFID Reader Window ...33

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RFID Contrast Identification Accessory for MEDRAD® Stellant Injection System with Certegra™ Workstation

E.2 Cleaning the RFID Reader Housing...33

F Dimensions ...35 G Environmental Specifications ...37 G.1 Operating ...37 G.2 Non-operating (Transportation and Storage)...37 G.3 Wireless Communication ...37

H Replacement Parts List...39

Operation, Installation and Service Manual

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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.

1.1 Intended Use The RFID Reader is intended to automatically capture the information listed above from prefilled CT cartridges and transfer that information to the Certegra Workstation.

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: QReorient or relocate the receiving antenna. QIncrease the separation between the equipment and receiver. 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.

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

1.3 Contraindications None known.

1.4 Required Training This device is intended to be used by individuals with adequate training and experience in diagnostic imaging studies.

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.

Compliance Mark for Japan Radio Law.

Japan Automatic Identification System Association.

Recycle batteries following hospital protocols and local environmental regulations.

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

Dispose of batteries properly in accordance with hospital and local regulations. Do not incinerate.

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1.6 Definition of Terms WARNING

 CAUTION

Indicates that the information is a warning. Warnings advise you of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system. Indicates that the information is a caution. Cautions advise you of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.

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.

1.7 System Configuration

Figure 1 - 1: Reading and Confirming RFID Information

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

The RFID Reader is comprised of the following components:

RFID Reader Charging Base attached to CWS

Charging Pins

Pairing Barcode

Unpair Button

RFID Reader

Light Emitting Diode (LED) Indicators

Primary Button

Charging Contacts

Figure 1 - 2: RFID Reader and Charging Base attached to CWS

Operation, Installation and Service Manual

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)

Figure 1 - 4: Fluid Panel displaying RFID Tag Information

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Figure 1 - 5: Data Confirmation displaying RFID Tag Information

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Using the RFID Reader

The RFID Reader can be used both in the Control room and the Scanner room to capture and transfer CT contrast information to the CWS. The RFID Reader can stay in its Charging Base on the CWS, where it remains activated. The RFID Reader also works separately, away from the CWS. 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.

2.1 Conditions for Valid RFID Reading The RFID can read the RFID tag on the prefilled CT cartridge if the system is not engaged in arming, holding, or injecting. If the system is engaged in arming, holding, or injecting, the reading cannot be done until the activity is complete.

Figure 2 - 1: Home Screen

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

2.2 In the Charging Base To use the RFID Reader stored in the Charging Base: 1.

Make sure that the RFID Reader is active (green LED on) or charging (red and green LEDs alternating on). 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.

Figure 2 - 2: Transferring Fluid Information to CWS

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2.3 Removed from Charging Base To use the RFID Reader: 1.

Remove the RFID Reader from its Charging Base. 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).

Figure 2 - 3: Fluid Information Displayed on CWS Informatics Panel 3.

Check the Informatics panel on the CWS to confirm the correct fluid information is displayed. 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.

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

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Troubleshooting the RFID Reader

If there is trouble with the RFID Reader, one of the following may be the cause. Q

The Charging Base is not properly connected to the CWS

Q

The RFID Reader is not properly seated in the Charging Base

Q

The RFID Reader is not charged

Q

The RFID Reader is in sleep mode

Q

The RFID Reader is out of range

Q

The RFID Reader is not paired to the CWS

Q

The RFID tag may be defective

3.1 Checking State of CWS 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.

3.2 Checking RFID Reader Connection (in Charging Base) To check the RFID Reader is properly connected to the CWS: 1.

Verify the CWS is turned on (verify green light above Power button is on).

2.

Verify the RFID Reader cable is properly plugged into the CWS USB port. NOTE: The CWS may require rebooting at this point.

3.3 Checking RFID Reader (in Charging Base) 1.

Verify the RFID Reader is seated properly in its Charging Base (at least one LED is on or flashing).

3.4 Checking RFID Reader (out of Charging Base) To check that the RFID Reader is properly charged: 1.

Verify the RFID Reader is active (green LED on). NOTE: If the RFID Reader’s red LED is flashing, it indicates that the battery is low.

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

3.5 Determining if RFID Reader is in Sleep mode If the RFID Reader is not in its Charging Base, it will automatically go into Sleep mode after one minute of inactivity. This is indicated by three distinctive beeps that change pitch from high to low, along with all LEDs turning off. If the RFID Reader is not in its Charging Base and no LEDs are on or flashing, it may be in Sleep mode. To wake the RFID Reader from Sleep mode: 1.

Press and release the RFID Reader’s primary button. The red and green LEDs should flash at the same time, and the RFID Reader will emit an audible ticking noise, followed by three ascending beeps. The green LED will turn on.

Figure 3 - 1: RFID Reader Waking from Sleep Mode NOTE: The RFID reader must be active (green LED on) to read a tag.

3.6 Determining if RFID Reader is Out of Range The RFID Reader has wireless communication with its Charging Base, which provides a communication range of nine meters (30 ft.) of unobstructed free space between the RFID Reader and its Charging Base. If an RFID tag is scanned while out-of-range, the RFID Reader will emit a high-pitched beep and the green LED will flash to indicate that the fluid data was captured, followed by an audible ticking noise to indicate that the RFID Reader is out-of-range. Once the RFID Reader is in-range and active, the green LED will flash again and the RFID Reader will emit a second beep, confirming the RFID Reader has successfully transferred the fluid information to the CWS. If the RFID Reader is not returned to in-range within one minute, the RFID Reader will enter sleep mode and the fluid data will be lost.

3.7 Determining if RFID Reader is Paired with the CWS If the RFID Reader is not paired correctly, it will not be able to transfer CT contrast fluid information to the CWS. When this happens, the RFID Reader will emit a low-pitched beep and the red LED will illuminate when trying to send information to the CWS. To verify the RFID Reader is paired to the Charging Base, perform the following: 1.

Remove the RFID Reader from the Charging Base and wait for the RFID Reader to enter sleep mode (all LEDs off).

2.

Place the RFID Reader into the Charging Base.

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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.

3.7.1 Pairing the RFID Reader 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.

Figure 3 - 2: Wireless Communication Whenever the CWS is powered up, the Charging Base will automatically communicate with its RFID Reader. This is indicated by a steady ticking sound that ends with three ascending beeps to indicate that the pairing was successful. As illustrated next, to manually pair the RFID Reader device with its Charging Base (post-installation, if needed): 1.

Remove the RFID Reader from its Charging Base. Press and hold the unpair button on the Charging Base for three seconds.

Press and Hold Unpair Button on Charging Base for Three Seconds

Figure 3 - 3: Pressing and Holding Unpair Button

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

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. Press and Hold RFID Reader’s Primary Button

Figure 3 - 4: Pairing the Charging Base with the RFID Reader

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3.7.2 Unpairing the RFID Reader The RFID Reader can be unpaired from its Charging Base by pressing and holding for three seconds the unpair button located inside the Charging Base. This action ends the wireless communication between the device and the Charging Base associated with the CWS.

Figure 3 - 5: Unpairing the RFID Reader 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.

3.8 Determining if the RFID Tag may be Defective The RFID Reader will emit a low-pitched beep and the red LED will flash to indicate there is an issue with reading the RFID tag. Alternatively, the RFID Reader may give no response if the RFID tag is defective. To troubleshoot RFID tag function, read a second tag of the same product to see if the RFID Reader is able to read it properly.

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RFID Contrast Identificatoin Accessory for MEDRAD® Stellant CT Injection System with Certegra™ Workstation

Operation, Installation and Service Manual

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Audio and Visual Feedback Indicators

Refer to the table below for the various audio and visual feedback indicators used by the RFID Reader as part of its operation.

Meaning

Tone

LEDs

General Power up

-

Red/Green Flash once

Establishing wireless connection to base

Ticking repeating every 0.5 second

-

Successful connection to Charging Base

Three ascending beeps

Green Flash once

Unsuccessful connection to Charging Base

Long low beep

Red Flash once

Charging and ready to read RFID tag

-

Red/Green Flash multiple times

Active and ready to read RFID tag

-

Green

Battery low

-

Red Flash multiple times

Entering sleep mode

Three descending beeps

-

Sleep mode or no power (depleted battery or base unpowered)

-

-

RFID Reading Successful RFID read

Short high beep

Green Flash once

Successful fluid information display on CWS

Long high beep

Green Flash once

- Unsuccessful fluid information display on CWS - Unsuccessful connection to Charging Base - CWS not in “idle” state (see Section 2.1)

Long low beep

Red Flash once

Wireless Connection Establishing wireless connection to base

Ticking repeating every 0.5 second

-

Successful wireless connection

Three ascending beeps

-

Unsuccessful wireless connection

Long low beep

Red Flash once