BD ALARIS MRI Capsule Directions for Use Issue 3 Oct 2021

BD Alaris™ MRI Capsule 

Contents

Page

Introduction... 3 Intended Use... 3 Compatible Alaris™ Infusion Pumps for MRI Capsule... 3 Intended Positioning of the MRI Capsule... 5 Intended user population... 5 Intended patient population... 5 Contraindications... 5 About This Manual... 6 Conventions Used in this Manual... 6 Controls and Indicators... 7 Controls... 7 Indicators... 7 Magnetic Indicator... 8 Symbol Definitions... 9 Labelling Symbols... 9 Features of the MRI Capsule... 10 Trolley... 11 Configurations... 12 Compatible Infusion Sets... 13 Height Adjustable Poles... 15 Power Input... 16 Battery Supply... 16 AC Power Output to Infusion Pumps... 16 System Notifications... 17 System Fault Indication... 18 Pump Alarm Location Beacon... 19 Operating Precautions... 20 Operating Environment... 20 Electromagnetic Compatibility and Interference... 20 Hazards... 21 Operation of the MRI Capsule... 23 Switching On... 23 Switching Off... 23 Resetting the MRI Capsule... 23 The MRI Capsule in the MRI Environment... 24 Control Room... 24 Getting Started in the MRI Room... 26 Product Specifications... 28 Electrical... 28 Battery... 28 Environmental... 28 Mode of Operation... 28 Regulatory Compliance... 29 Potential Equalisation Conductor... 29 Physical... 29 Maintenance... 30 Routine Maintenance Procedures... 30 Battery... 30 Replacing the AC Power Fuses... 30 Recommended Cleaning... 31 Disposal... 32 Spare Parts... 33 BDDF00697 Issue 3

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BD Alaris™ MRI Capsule 

Spare Parts... 33 Contact Us... 34 Electromagnetic Emissions... 35 Electromagnetic Immunity... 36 Recommended Separation Distances... 38 Document History... 40

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BD Alaris™ MRI Capsule Introduction

Introduction MRI Scanners use strong magnetic fields that can cause partial or permanent damage to Infusion Pumps. The BD Alaris™ MRI Capsule (hereinafter referred to as MRI Capsule) has been designed to allow the hospital staff to use the Alaris™ Infusion Pumps in the MRI environment. There is no need for complicated and expensive non-magnetic Infusion Pumps specially designed for the MRI use. The MRI Capsule will be used to provide mounting, power and Pump Alarm Location Beacon display of Infusion Pumps within the operating environment range specified in this Directions For Use (DFU).

Intended Use The MRI Capsule is designed for use in a Professional Healthcare Facility Environment and to be used in Magnetic Resonances Systems environment with controlled access. The MRI Capsule is intended to be used to protect the MRI images from RF wave interference and also prevent the MRI Scanner from attracting infusion pumps to the magnet. The MRI Capsule is designed to not directly impact or prevent the infusion delivery process. Only BD authorized pumps can be used with the MRI Capsule. The MRI Capsule is designed to accommodate the following Pumps which will communicate with the Pump Alarm Location Beacon for High, Medium and Low priority alarms where applicable. For further alarm information, refer to Pump DFU. Note: The User should confirm that Wi-Fi is disabled on Pumps prior to use in the MRI Capsule.

Compatible Alaris™ Infusion Pumps for MRI Capsule Pump Model

Model Code

Minimum Supported Firmware Version

Alaris™ CC Syringe Pump (All variants)

80033UN01 80033UN01-G 8003MED01 8003MED01-G 8003TIG01 8003TIG01-G 8003TIG03 8003TIG03-G

All

Alaris™ GH Syringe Pump (All variants)

80023UN01 80023UN01-G 8002MED01 8002MED01-G 8002TIG01 8002TIG01-G 8002TIG03 8002TIG03-G

All

Alaris™ PK Syringe Pump (All variants)

80053UN01 8005PK201 8005TIG03

All

Alaris™ VP Plus Guardrails™ Volumetric Pump (All variants)

9003MED01-G 9003TIG01-G 9003TIG03-G

v1.4.9

BD Alaris™ neXus CC Syringe Pump

CCneXus1 CCneXus1-S

All

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BD Alaris™ MRI Capsule Introduction

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If a compatible Pump is visibly damaged, there is the possibility that RF interference could cause artefact to the scan image, and a replacement Pump may be required. Prior to commencing the scan it is advised that the image be checked for any interference. Prior to using an Alaris™ VP Plus Guardrails Volumetric Pump with the MRI Capsule, check the firmware version of the Pump. If it is below v1.4.9, do not use with the MRI Capsule, as it would require the use of a Model 180 flow sensor. The Model 180 flow sensor is not compatible with the MRI Capsule. Arrange with your local BD representative for the Pump firmware to be upgraded to v1.4.9 or greater.

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The AeroScout tags, all models, are compatible with the BD Alaris™ MRI Capsule.

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BD Alaris™ MRI Capsule Introduction

Intended Positioning of the MRI Capsule The MRI Capsule incorporates a Magnetic Indicator that is used to safely position the MRI Capsule in relation to the MRI Scanner. The MRI Capsule should be positioned as near to the patient as possible, ensuring the Magnetic Indicator is illuminated Green which indicates a magnetic field density equal to or less than 20mT (millitesla).

Intended user population The MRI Capsule and its compatible Pumps can only be used by trained and qualified medical staff within the MRI environment.

Intended patient population The MRI Capsule can only be used on one patient at a time, and it serves the same population of patients as the compatible Alaris™ Infusion Pumps.

Contraindications The MRI Capsule is not designed to be used in Home Care environments. Please refer to the 'Product Specifications' section for more information.

Incompatible Alaris™ Infusion Pumps and Accessories for MRI Capsule Pump Model

Model Code

Alaris™ GW Volumetric Pump

All variants

Alaris™ GW 800 Volumetric Pump

All variants

Alaris™ GP Volumetric Pump (all variants)

All variants

Flow Sensor

180 180A

BD Alaris™ neXus GP Volumetric Pump

GPneXus1

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BD Alaris™ MRI Capsule About This Manual

About This Manual The user must be thoroughly familiar with the BD Alaris™ MRI Capsule described in this manual prior to use. Please refer to the relevant Directions For Use (DFU) for correct operation of the Pumps. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the MRI Capsule. These settings and values are for illustrative use only. The complete range of settings and values are shown in the Specifications section. The illustrations in this DFU show example configurations and equipment that might not be available to all markets and regions. Please contact the local BD office or distributor for further information.

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Keep this Manual for future reference during the MRI Capsule's operational life. It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided when the order is placed.

Conventions Used in this Manual Bold

Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, ON/OFF button.

‘Single quotes’

Used to indicate cross-references made to another section of this manual. For example, see ‘Battery Supply’.

Italics

Used to refer to other documents or manuals. For example, "refer to Pump DFU." Also used to define special terms e.g. MRI Capsule.

Note

Notes contain supplementary information or emphasize a point or procedure. Warning symbol. A warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the MRI Capsule.

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Caution symbol. A caution is a statement that alerts the user to the possibility of a problem with the MRI Capsule associated with its use or misuse. Such problems may include MRI Capsule or Pump malfunction, failure or damage, or damage to other property. The caution statement includes the precaution(s) that should be taken to avoid the hazard.

User

Person interacting with the MRI capsule and infusion devices connected to the patient while delivering treatment and monitors their use.

Qualified Service Personnel

Service and repair the product.

Control Room

This room is immediately adjacent to MRI room. It contains all the equipment required to control the MRI Scanner.

MRI Room

Magnetic Resonance Imaging rooms have strong magnetic fields. Equipment should be kept as near as possible to the patient with a limitation of 20 mT from the strongest magnetic point to avoid harm.

Tesla

Tesla is a unit of magnetic flux density.

Magnetic Field

Magnetic field is a region around magnetic material or changing electric field within which magnetic field is observable.

MRI

Magnetic Resonance Imaging is a diagnostic technique that produces detailed images of organs and tissues within the body using strong magnetic fields.

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BD Alaris™ MRI Capsule Controls and Indicators

Controls and Indicators

Controls Symbol

Description ON/OFF Button - Press once to switch the MRI Capsule on. Press and hold for two seconds to switch the MRI Capsule off. In the event that the system needs to be reset, press and hold for at least four seconds, then press again to switch the MRI Capsule on.

Indicators Symbol

Description Battery Indicator - When illuminated the MRI Capsule is operating from internal battery; when flashing the battery power is low and auto power down is imminent. AC Power Indicator - When illuminated the MRI Capsule is connected to the AC Power supply and the battery is being charged. A Status Indicator - Provides a visual indication of the internal software activity. B Status Indicator - Provides a visual indication of communication activity of the network within the MRI Capsule.

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ON Status Indicator - When illuminated the MRI Capsule is powered on. System Fault Indicator - The MRI Capsule will illuminate this indicator when an internal fault is present and detected or will momentarily illuminate when the MRI Capsule is operating from internal battery.

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BD Alaris™ MRI Capsule Controls and Indicators

Magnetic Indicator

The Magnetic Indicator is an integrated system to continuously measure the magnetic field strength in the MRI environment. The Magnetic Indicator is equipped with both visual and audio alarms. If the MRI Capsule is placed too close to the magnet bore, the Magnetic Indicator will alarm and data will be logged. The Magnetic Indicator is used to advise the user if the MRI Capsule is in a safe distance from the magnet bore. Indicator

Positioning

Risk

Magnetic Indicator Audio LED Colour Signal

Action

Magnetic field density <20mT

Low

Green LED flashes

No

The MRI Capsule is in position for safe operation.

Magnetic field density 20 - 40mT

Medium

Yellow LED flashes

Yes

Move the MRI Capsule until the Magnetic Indicator green LED flashes.

Magnetic field density >40mT

High

Red LED flashes

Yes

Move the MRI Capsule until the Magnetic Indicator green LED flashes.

Note: If the MRI Capsule is moved into an area where the Magnetic Indicator is flashing red and the Pump(s) do not alarm, they should be checked by Qualified Service Personnel at the earliest opportunity. If the magnetic indicator flashes red or yellow, and a simultaneous alarm is generated on the Pump(s), the Pump(s) must be replaced, and checked by a qualified service person before being used again. Indicator

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Description

Audio Signal

Battery Indicator - When flashing the battery power is low and auto power down is imminent. Contact Qualified Service Personnel to replace the battery.

Yes, single sound only

Error Indicator - The Magnetic Indicator will illuminate when an internal fault is present and detected.

Yes

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BD Alaris™ MRI Capsule Symbol Definitions

Symbol Definitions Labelling Symbols Symbol

Description

g

AC Power Inlet

W

Fuse Rating

Consult accompanying documents

x

Potential Equalisation (PE) Connector

r

Alternating Current MRI Capsule complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC.

IPX2

Protected against water droplets deflected up to 15° from vertical. Date of Manufacture Manufacturer

U

Dispose according to local environmental regulations about disposal of electronic waste.

M

Mass including its safe working load in kg

C V

Warning electrical shock hazard do not tamper. Electrostatic discharge (ESD) precautions MR conditional - The device does not cause any hazard in a specified MR Environment Product serial number Product reference / part number

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Features of the MRI Capsule

Height adjustable Pole with bag hanger hooks

Pump Alarm Location Beacon Keypad with Indicators Grooves for Infusion Sets to Volumetric Pumps

Door handle with a lock

Shielded window

Grooves for Infusion Sets from Infusion Pumps

Automatic Brakes

Manual Brakes

Magnetic Indicator

Handle used to position MRI Capsule with lever for automatic brakes

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BD Alaris™ MRI Capsule Features of the MRI Capsule

AC Power cable storage hooks

AC Power Inlet

Trolley When the MRI Capsule is not being transported or is positioned in place, the manual brakes should be engaged.

Automatic Brakes The automatic brake lever is located with the MRI Capsule handle. Squeeze and hold the brake lever to release the brakes and locate the MRI Capsule in the desired position. To engage the automatic brakes, release the brake lever.

Manual Brakes To operate the manual Trolley brakes: 1. Locate brake mechanism at the end of the wheels.

2. Press down to engage the brakes.

3. Pull up to disengage the brakes.

All wheels should be set to the same engaged or disengaged state. Prior to moving the MRI Capsule all brakes should be disengaged.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Configurations 3 Volumetric and 3 Syringe Pumps

4 Volumetric Pumps

4 Syringe Pumps

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Compatible Infusion Sets The following list of Compatible infusion and extension sets are recommended for use in the MRI Capsule with the Alaris™ Infusion pumps: MRI Capsule Product Compatible product Reference

Description

Alaris™ CC Syringe Pump

G30402M

Alaris™ CC Extension Set. 200cm. Pressure sensor disc. PVC.

G30453V

Alaris™ CC Extension Set. Low Sorbing. Light Resistant (Amber). 200cm. Pressure sensor disc. PE lined PVC.

G30302M

Alaris™ CC Extension Set. Low Sorbing. 206cm. 1 Pinch clamp. Pressure sensor disc. PE lined PVC.

MFX2213

Alaris™ CC Extension Set. 200cm. Low Sorbing. Pressure sensor disc. PVC.

MFX2211

Alaris™ CC TPN Extension Set. Light Resistant (Amber). 200cm. 1.2 µm filter. Pinch clamp. 1 Pinch clamp. Pressure sensor disc.

MFX2299E

Alaris™ CC Extension Set. Low Sorbing. SmartSite NeedleFree connector. 205cm. Pinch clamp. Pressure sensor disc. PE lined PVC.

G30653V

Alaris™ CC Extenstion Set. Light Resistant (Amber). 200cm. Pressure sensor disc. PVC.

MFX2294

Alaris™ CC Extension Set. Light Resistant (Amber). 205cm. Pinch clamp. Pressure sensor disc. PE lined PVC.

MFX2210

Alaris™ CC Extension Set. 200cm. Pressure sensor disc. 0.2 µm filter. Polyurethane.

MFX2206E

Alaris™ CC TPN System. Light Resistant (Amber). SmartSite Needle Free Valve. Auxilary set 205cm. 1 spiked drip chamber. Hydrophobic air inlet filter. 20 drops per ml. 2 pinch clamps. Pressure sensor disc. 15 µm Drip Chamber Filter.

Alaris™ GH Syringe Pump

G40720

Extension Set. Low Sorbing. 206cm. Pinch clamp.

G40015

Extension Set. 150cm. PVC.

Alaris™ PK Syringe Pump

G40020B

Extension Set. 200cm. PVC.

G40615K

Extension Set. 150cm. Polyethylene. Low sorbing.

G40620K

Extension Set. 200cm. Polyethylene. Low Sorbing.

30852

Y Extension Set. 183cm. 2 way Y Connector. 2 pinch clamps. 1 back-check valve. 1 female luer anti-siphon valve. PVC.

30832

Y Extension Set. 178 cm. 2 Way Y Connector. 1 Female Luer Y Site. 2 Pinch Clamps. 1 Back-Check Valve. Rotating Male Luer. PVC

MFX1952

Spiral tubing extension set. 200cm. Low sorbing. Polyethylene. 1 Slide clamp.

MFX1953

Spiral tubing extension set. 300cm. Low sorbing. Polyethylene. 1 Slide clamp.

MFX1954

Spiral tubing extension set. 400cm. Low sorbing. Polyethylene. 1 Slide clamp.

G40015

Extension Set. 150cm. PVC.

04100010162

Extension Set. 105cm.

70593

Alaris™ VP Infusion set. 300cm. 15 µm filter. Pressure sensor disc. 1 Roller Clamp. PVC. 1 Roller Clamp. 1 Pinch Clamp. PVC.

70693E

Alaris™ VP infusion set. 265cm. 15 µm filter. Pressure sensor disc. 1 SmartSite valve Y port.

70643

Alaris™ VP infusion set. 300cm. 15 µm filter. Pressure sensor disc. Light Resistant (Amber). 1 Roller Clamp. 1 Pinch Clamp. PVC.

70895

Alaris™ VP Transfusion Set. 300cm. 200 µm filter. Pressure sensor disc. 1 Roller Clamp. 1 Pinch Clamp. PVC.

Alaris™ VP Plus Guardrails™ Volumetric Pump

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Precautions while managing Infusion and Extension Sets from Alaris™ Infusion Pumps: • Ensure the sets are securely located in the grooves, when closing the MRI Capsule door and when installing the pumps. • After installing a pump, ensure its related set is correctly placed within the grooves of its associated outlet. All these sets and accessories have been tested for compatibility in a MRI environment. It is recommended that sets are changed according to the Directions for Use. Carefully read the Directions for Use supplied with the set prior to use.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Height Adjustable Poles The height adjustable poles have been designed as a convenient means of securing the fluid bags onto the MRI Capsule. The height adjustable poles support a maximum load of 4 kg (i.e. 2 kg per height adjustable pole). The height adjustable poles are held securely by a clamp and a slip catch. This gives additional flexibility when selecting the required height of the fluid bags.

Recommended Height For The Fluids For The Alaris™ VP Plus Guardrails™ Volumetric Pump Hang the fluid container at a minimum height of 45 cm from the bottom of the Pump to the bottom of the fluid container. Raise the fluid container higher than the minimum height where possible, to minimise loops and kinks in the infusion set tubing.

45cm minimum

To operate the clamp: 1. Grip the handle at the lower end of the pole and carefully loosen the hand wheel. 2. Apply an upward pressure to the pole handle, this will release the locking lever and allow the pole to move freely. 3. Changing the bag hanger height:

3b

a) To increase the bag hanger height: Continue pushing the pole upward to the required height. Once set, release the pressure on the pole, reengaging the locking lever.

2

b) To reduce the bag hanger height: Hold the locking lever in the released position and adjust the pole downward to the required height. Release the locking lever and release the pressure on the pole, re-engaging the locking lever. 4. Tighten the hand wheel to securely lock the pole into position.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Power Input The MRI Capsule is powered from the AC Power Supply through a standard IEC AC Power connector (i.e. C13, C14). When connected to the AC Power Supply the AC Power indicator is illuminated. Both the Live and Neutral lines of the main supply are protected using fuses carried in a double fuse holder located on the AC Power Supply inlet connector. When connected to the AC Power Supply, a three wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, then the MRI Capsule must not be used.

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To isolate the MRI Capsule from the AC Power Supply remove the AC Power cord from the source socket. The MRI Capsule should be positioned to allow access for disconnecting the AC Power cord.

Battery Supply There are two batteries in the MRI Capsule:

MRI Capsule Internal Battery The MRI Capsule should normally be operated from the AC Power supply. However, in the event of temporary loss of AC Power, an internal power supply will provide approximately 60 minutes of backup power. AC Power to the Pumps will be discontinued. AC Power should be re-applied as soon as possible as there will be no AC Power supplied to the Pumps while the MRI Capsule is running on the battery. Note: When the AC Power is disconnected, the Pumps on the MRI Capsule Medical Device Interface (MDI) tiles (herein after referred to as tiles) that generate an alarm will be replicated on the Pump Alarm Location Beacon. The Battery indicator illuminates whenever the MRI Capsule is running from the internal battery. When illuminated the MRI Capsule is operating from internal battery; when flashing the battery power is low and auto power down is imminent. The battery is automatically charged whenever the MRI Capsule is connected to the AC Power Supply. As the MRI Capsule is designed to operate from the AC Power supply it will only power up when connected to the AC Power Supply. If transfer of the MRI Capsule is required, then prior to disconnecting from AC Power supply the User must ensure there is sufficient battery power on each of the Pumps.

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In the event of a power loss, the MRI Capsule will provide a visual indicator and emit an audible tone every 30 seconds for the first 14 minutes to alert operators. This audible tone and visual indicator will escalate to every 15 seconds after 14 minutes until the battery is fully depleted. These tones and indications should not be confused with the continuous alarm and LED notification that is initiated if the MRI Capsule exhibits a fault condition.

Magnetic Indicator Battery The Magnetic Indicator has an independent Primary Alkaline Battery. It is a non-rechargeable battery to provide power to the Magnetic Indicator. The function of the battery is to operate the Magnetic Indicator independently from the AC Power supply or the MRI Capsule internal battery. The battery indicator of the Magnetic Indicator will be flashing when the battery power is low and BD recommends replacing the battery every two years. Please contact Qualified Service Personnel to replace the battery. Note: The Magnetic Indicator will always be on.

AC Power Output to Infusion Pumps The MRI Capsule has its own power distribution circuit to supply AC Power to the attached Pumps. Each MRI Capsule tile IEC connector will have AC Power present on the connector, without the Pump attached to the MRI Capsule, and the tile green LED will be illuminated. When a Pump is fully attached to the MRI Capsule tile the AC Power indicator on the Pump will illuminate to indicate the Pump is powered and charging. The MRI Capsule tile AC Power outlet connection is intended only for connection to the aforementioned Pumps. Please refer to the compatibility matrix in the ‘Intended Use’ section of this guide. Never attach any other equipment to the outlet connector.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

System Notifications The MRI Capsule is equipped with both audio and visual notifications to promote user awareness. System Notifications have been segregated into three different categories: Status Notifications, System Fault Indications and Pump Alarms, based on their required response and method of user awareness. All System Notifications generated by the MRI Capsule are considered Information Signals. They are not used to indicate an Alarm State but maybe used to replicate an Alarm Signal present on the attached Pumps. The Primary and Secondary Speakers are used to generate the auditory notifications. The purpose of the Primary speaker is to relay the MRI Capsule status. Whereas the Secondary speaker indicates a failure within the system. The table below summarizes the behaviour of the auditory speakers. Audio Generator

Approximate Sound Pressure Level at 1 metre

Notification Type

Primary Speaker

≤ 45 dB(A)

Informational

Secondary Speaker

≥ 45 dB(A)

Informational

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In some user environments the Sound Pressure Level of the Primary and Secondary Speakers could be less than the ambient noise.

A high level summary of the System notifications can be found in the table below. Status Notifications are represented by small LEDs and are the only System Notifications that use the primary speaker. System Fault Indications are represented by the System Fault Indicator and use the secondary speaker. The Pump Alarm Location Beacon is used to replicate the Pump Alarm Condition. Trigger

Visual Indicator

Audio Indicator

Category

Description

MRI Capsule AC Power Disconnect

Battery Indicator and System Fault Indicator flash momentarily

Momentary audible tone on Secondary Speaker

Status

See ‘Battery Supply’

Pump Alarm

Pump Alarm Location Beacon

N/A

Pump Alarm

See ‘Pump Alarm Location Beacon’

Power on

On Status Indicator

Both Speakers

Status

See ‘Operation of MRI Capsule’

SFI

System Fault Indicator

Secondary Speaker

Fault

See ‘System Fault Indication’

MRI Capsule in area for safe operation

Magnetic Indicator green LED flashing

N/A

Status

See 'Magnetic Indicator'

MRI Capsule in area unsafe for operation

Magnetic Indicator yellow Magnetic Status LED flashing Indicator Speaker

See 'Magnetic Indicator'

MRI Capsule in area unsafe for operation too close to the magnet bore

Magnetic Indicator red LED flashing

See 'Magnetic Indicator'

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Magnetic Status Indicator Speaker

It is recommended that all Pumps in a single care area be configured with the same alarm tones, where applicable, to avoid User confusion. The Hospital/Facility is responsible for selecting and configuring the desired alarm scheme. Refer to each individual Pump’s Directions for Use for further details on the alarm schemes. The User should always refer to the alarm on the Pump for the correct priority.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

System Fault Indication Continuous monitoring of the power distribution and communications system integrity is performed by the MRI Capsule. In the event that a system fault occurs whilst in use, the System Fault Indicator will be illuminated accompanied by an audible tone. To avoid any possible interruption to the infusion, AC Power to the Pumps will be maintained on the MRI Capsule tile should a system fault be detected. In addition to scenarios described above the MRI Capsule also briefly illuminates the System Fault Indicator and activates the audible tone each time the MRI Capsule is switched on. Trigger

Visual Indicator

Audio Indicator

Description

Communication Failure

System Fault Indicator

Secondary Speaker

Communication failure of the internal components of the MRI Capsule.

POST failure

System Fault Indicator

Secondary Speaker

Failure of any of the step defined in the ‘Operation of MRI Capsule’ Section

If the System Fault Indicator fails to illuminate when the MRI Capsule is switched on, remove the MRI Capsule from service and contact Qualified Service Personnel. Should a System Fault occur during use, remove the MRI Capsule from service as soon as possible and contact Qualified Service Personnel.

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The MRI Capsule auditory SFI signal is a continuous tone.

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BD Alaris™ MRI Capsule Features of the MRI Capsule

Pump Alarm Location Beacon The Pump Alarm Location Beacon is mounted at the top of the MRI Capsule to assist with identifying the presence of any alarms generated by the Pumps. When lit, the Pump Alarm Location Beacon colour matches that of the visual status indicator on the Pumps. Alarms of high priority, such as when an infusion is terminated are reflected as flashing Red. Alarms of medium priority, such as Battery Low, are reflected as flashing or solid Yellow. Alarms of low priority, such as AC Power Disconnection, are reflected as solid Yellow. The Pump Alarm Location Beacon will indicate the highest priority of alarm if there are multiple Pumps in an alarm state. The Pump Alarm Location Beacon flashes automatically whenever any Pump located on an MRI Capsule Tile enters the alarm condition, and stops when the condition is cleared on the Pump. The Pump Alarm Location Beacon automatically illuminates Red then Yellow each time the MRI Capsule is switched on. The Pump Alarm Location Beacon alerts the user to a Pump being in an alarm condition whilst it is connected to the MRI Capsule, it does not replace the alarm on the Pump which remains the principle indicator that the attention of a clinician is required. A summary of the Pump Alarm Priority Level Indicators can be found below. Pump Alarm Priority

Colour

Frequency

HIGH Priority

Red

Flashing faster than Medium Priority

MEDIUM Priority

Yellow

Flashing or solid

LOW Priority

Yellow

Solid

Note: In the occurrence of a Pump alarm being transmitted to the alarm location beacon, the clinician must decide on the urgency of alarm by referring to the Pump’s DFU to determine whether it needs to be rectified. If the clinician decides they need to rectify the alarm condition, they must follow the local hospital policy for entering the scan room. To clear the Pump Alarm Location Beacon state on the MRI Capsule, the clinician has to clear the alarm state on the Pump first. If the Pump Alarm Location Beacon fails to illuminate when the MRI Capsule is switched on, suspect a fault. Remove the MRI Capsule from service and contact Qualified Service Personnel.

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There may be a delay, of approximately six seconds, between the Pump going into alarm and the Pump Alarm Location Beacon activating via the MRI Capsule. In the event of a communication fault between the MRI Capsule and the Pump, the MRI Capsule Pump Alarm Location Beacon and Pump Alarm Beacon may not be synchronised. In this case, refer to the Pump’s Alarm status. Communication faults could result from hardware failures or incorrect configuration of the Pump communication parameters

Note: See the ‘Introduction’ section for lists of the Pump Alarm Location Beacon compatibility between the Pumps and MRI Capsule. Note: Refer to the individual Pump DFU for alarm priority information.

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