MRI Guard Agilia Range Infusion Pumps Instructions for Use Nov 2012

Release Notes Date

Software version

Description

November 2012

1.x

Creation

Local contacts for servicing Complete this box with your contacts:

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6640-1_IFU_MRI_Guard_Agilia_Int

Table of contents 1

INTRODUCTION 5 1.1 INSTRUCTIONS FOR USE: DESCRIPTION OF SYMBOLS ... 5 1.2 INTENDED USE ... 6

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MRI GUARD AGILIA DESCRIPTION 8 2.1 MRI GUARD AGILIA SYSTEM DEFINITION ... 8 2.2 FRONT VIEW (DOOR CLOSED)... 9 2.3 FRONT VIEW (DOOR OPENED) ... 9 2.4 CAP USER INTERFACE ... 10 2.5 SIDE VIEW (RIGHT SIDE) ... 11 2.6 SIDE VIEW (LEFT SIDE) ... 12 2.7 BACK VIEW ... 13

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DEVICE LABELLING 14 3.1 DEVICE IDENTIFICATION LABEL... 14 3.2 LABELS ON THE SYSTEM ... 15 3.3 LABEL ON MAGNET INDICATOR’S BATTERY PACK ... 15

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MRI GUARD AGILIA AND INFUSION PUMPS: INSTALLATION AND REMOVAL 16 4.1 PACKAGING CONTENT ... 16 4.2 MRI GUARD AGILIA INSTALLATION AND REMOVAL ... 17 4.3 AGILIA IV INFUSION PUMPS INSTALLATION AND REMOVAL ... 19

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MRI GUARD AGILIA IN MR ROOM 26 5.1 GET STARTED IN THE MR ROOM ... 26 5.2 MAGNET INDICATOR ... 33

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SIGNALING 36 6.1 ALARM AND PRE-ALARM CENTRALIZATION FOR THE IV AGILIA INFUSION PUMPS ... 36 6.2 POWER SUPPLY, CAP USER INTERFACE’S BATTERY AND SYSTEM DISPLAYS AND STATUS ... 38 6.3 MAGNET INDICATOR ... 40

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BATTERIES AND MAINS CONNECTION 41 7.1 CAP USER INTERFACE’S RECHARGEABLE BATTERY PRECAUTIONS OF USE ... 42 7.2 SWITCHING ON AND OFF... 42 7.3 CAP USER INTERFACE’S BATTERY OPERATING MODE ... 43 7.4 MAGNET INDICATOR’S BATTERY PACK ... 44

6640-1_IFU_MRI_Guard_Agilia_Int

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RECOMMENDATIONS FOR CLEANING 45 8.1 PROHIBITED CLEANING AGENTS ... 45 8.2 PRECAUTIONS FOR CLEANING... 45 8.3 RECOMMENDED CLEANING AGENTS ... 45 8.4 CLEANING GUIDELINES AND PROTOCOL ... 46

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MRI GUARD AGILIA STORAGE 47 9.1 PRECAUTIONS FOR STORAGE ... 47 9.2 STORAGE AND TRANSPORT CONDITIONS ... 47 9.3 PREPARING THE DEVICE FOR STORAGE... 48 9.4 INSTALLING THE DEVICE AFTER STORAGE ... 48

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MRI GUARD AGILIA: QUICK CHECK PROTOCOL

11 TROUBLESHOOTING AND MESSAGES

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12 SERVICING 54 12.1 SERVICE POLICY AND RULES ... 54 12.2 MAINTENANCE REQUIREMENTS ... 54 12.3 QUALITY CONTROL ... 55 13 ORDERING INFORMATION 56 13.1 MRI GUARD AGILIA PACKAGING ... 56 13.2 SPARE PARTS ... 56 14 TECHNICAL SPECIFICATIONS 57 14.1 TECHNICAL DATA ... 57 14.2 ELECTROMAGNETIC COMPATIBILITY ... 60 15 WARRANTY 69 15.1 GENERAL CONDITIONS OF WARRANTY ... 69 15.2 LIMITED WARRANTY ... 69 15.3 WARRANTY CONDITIONS FOR BATTERIES AND ACCESSORIES ... 69 16 RECYCLING AND DISPOSAL

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17 SOFTWARE LICENSES

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18 INDEX OF KEYWORDS

89

19 GLOSSARY OF TERMS

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Valid for software version 1.x (x meaning any value). To identify the software version of the MRI Guard Agilia, please refer to the identification label on the device.

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6640-1_IFU_MRI_Guard_Agilia_Int

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Introduction

The MRI Guard Agilia is intended to accommodate and power up to four infusion pumps of the Agilia range (Injectomat Agilia, Injectomat MC Agilia, Injectomat TIVA Agilia, Volumat Agilia, and Volumat MC Agilia). With the MRI Guard Agilia, these infusion pumps can be operated in a Magnetic Resonance Imaging unit. The intended position in the MRI unit is as near as possible to the patient in the MRI unit with a limitation of 20 mT/200 Gauss as the maximum magnetic field density. Due to its construction principle, the MRI Guard Agilia reduces the interferences between the IV infusion pumps inside the device and the MRI Scanner as long as a trouble-free operation of all equipment is ensured. The operator is supposed to have a suitable qualification. The use of MRI Guard Agilia does not change the standalone pump behaviour.

1.1 Instructions for use: description of symbols Warning:  These Instructions for use are applicable to the MRI Guard Agilia.  The user must adhere to the instructions specified in these IFU. Failure to adhere to these instructions may result in damages to the equipment, injuries to patients or injuries to users. Specific texts are highlighted using the symbols described below. Symbol DANGER

Description Danger: alert to an imminent hazard which could result in serious personal injury and/or product damage if the written instructions are not followed. Warning symbol: alert to a potential hazard which could result in serious personal injury and/or product damage if the written instructions are not followed. Caution symbol: an alert to a potential hazard which could result in minor personal injury and/or product damage if the written instructions are not followed. Information symbol: Recommendations to be followed.

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1.2 Intended use Warning:  Before using the MRI Guard Agilia system, read all accompanying documents provided with MRI Guard Agilia, Agilia IV Infusion pumps and accessories.  Make sure to have fully understood how to use the device in order to assure your safety and the safety of the patient. Give a particular attention to the texts which are highlighted by a symbol.

1.2.1

Intended positioning

The MRI Guard Agilia is used to ensure a trouble-free operation of Agilia IV Infusion pumps in a Magnetic Resonance Imaging unit. The MRI Guard Agilia can be loaded with Agilia IV infusion pumps which can be operated in the same way as under normal conditions, in order to limit –as often as possible- the use of extra lines. Therefore the user workflow is optimized. The integrated Magnet Indicator supports the operator to find the optimum place in the safe area close to the patient and far enough from the MRI Scanner. The intended position is as near as possible to the patient in the MRI unit, but with the limitation of a maximum magnetic field density of 20 mT/200 Gauss which is equivalent to a distance of approximately 1.5 m by an active shielded 3 Tesla MRI Scanner.

1.2.2 Intended patient population Warning:  Make sure that all Agilia IV infusion pumps installed in one MRI Guard Agilia are only connected to a single patient.  Never have several patients connected at the same time to the same MRI Guard Agilia. MRI Guard Agilia in combination with Agilia IV Infusion pumps is intended to be used on the same patient population as the Agilia IV infusion pumps.

1.2.3 Intended user population Warning:  MRI Guard Agilia must only be used by qualified and trained medical staff.  In order to be trained, please contact your Fresenius Kabi representative or a certified trainer. 6

1.2.4 Intended conditions of use 1.2.4.1 DANGER

Contraindications

Danger!  MRI Guard Agilia is not designed to be used in an explosive or flammable environment due to risk of ignition. Warning:  MRI Guard Agilia is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive or flammable environment or ultrasonic and ionizing radiation (eg: X-Ray) environments.  Do not use drop sensor neither outside of the MRI Guard Agilia, nor inside of the MRI Guard Agilia.  Please refer to the 'Use environment' and the 'Technical specifications' sections in this document for additional information and requirements about the use environment. 1.2.4.2 Use environment MRI Guard Agilia is intended to be used in the MR Environment. Information:  Temperature operating range: 5°C (41°F) to 40°C (104°F)  Storage temperature: -10°C (14°F) to +60°C (140°F)  Pressure operating range: 700 hPa (525 mmHg / 10.15 PSI) to 1060 hPa (795 mmHg / 15.37 PSI)  Storage pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg / 15.37 PSI)  Humidity operating range: 20% to 90%, no condensation  Storage humidity: 10% to 90%, no condensation  Altitude: max 3000 m (9842.52 ft)

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MRI Guard Agilia description

2.1 MRI Guard Agilia system definition The MRI Guard Agilia system is composed of the following elements:  1 MRI Guard Agilia rack able to stack 4 Agilia IV infusion pumps with a power cord (Position 1).  Trolley with automatic castor brake (Position 2) and IV Pole (Position 3).  Up to 4 Agilia IV Infusion pumps with their respective accessories, disposables and documents.

Legend: 1 MRI Guard Agilia (housing with

door; integrated rack for Agilia IV infusion pumps; Magnet Indicator)

2 Trolley with automatic castor

brake and footbrake

3 IV pole 5 Door lever 6 Lever for automatic castor

brake

7 Two castors with footbrake

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2.2 Front view (Door closed)

Legend: 5 Door lever 8 Cap user interface 9 Magnet Indicator (display)

2.3 Front view (Door opened) Legend: 10 Pump lock / release mechanism

lever

11 Pump shelf 12 Pump power inlet 13 Infrared communication window 14 Four outlets for IV infusion lines

of Volumat and Injectomat pumps (1 for each pump)

15 Plastic bumper 16 Inlet for up to 4 Volumat Lines 17 Holder for Volumat Lines 18 Hook to hang bag for Volumat

pump in lowest shelf 19 Magnet Indicator’s Battery pack 20 Power status indicator

Symbol

Location

Symbol description

On pump lock / release mechanism lever

Pushing area to lock and unlock pumps from MRI Guard 9

2.4 Cap user interface

Legend: 21 Alarm centralization LED 22 Power status LED 23 Cap user interface’s battery LED 24 System status LED

Symbol

Location

Symbol description Power status

Cap user interface

Charge status of the Cap user interface’s battery System status

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2.5 Side view (right side)

Legend: 7 Castor with footbrake 25 Hand ball 26 Handle of automatic castor brake

A: STOP position of automatic castor brake B: MOVE position of automatic castor brake 27 Castor of automatic castor brake

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2.6 Side view (left side)

Legend: 7 Castor with footbrake 14 Four outlets for IV-lines 16 Inlet for up to 4 Volumat Lines 25 Hand ball 26 Handle of automatic castor brake

A: STOP position of automatic castor brake B: MOVE position of automatic castor brake 27 Castor of automatic castor brake

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2.7 Back view

Legend: 28 Device identification label 29 Power/Mains connection

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Device labelling

3.1 Device identification label Position: On back side of housing, next to Power/Mains connection. Symbol

Description Product reference / part number Product serial number Input terminal - connector Output terminal - connector Electrical fuses Alternating Current (AC) Protection against leakage current; type B applied part

IP21

Index of protection against splashing liquids Not to be used in residential area Obligation for the user to refer to the Instructions for use Part included in a recovery / recycling process CE Marking Name and address of the manufacturer / Date of manufacture

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3.2 Labels on the system Symbol

< 4 kg

Position

Description

On the door lever

General warning sign

Near device identification label and inside the housing

MR conditional: (The device does not cause any hazard in a specified MR Environment) MRI Scanner: 1.5 Tesla and 3.0 Tesla Magnetic Field: max. 20 mT

IV Pole

Maximum Load < 4 kg

Push the pump firmly so that the Inside the housing locking mechanism secures the pump

3.3 Label on Magnet Indicator’s battery pack Position: On Magnet Indicator’s battery pack (Pos. 19). Symbol

Description Battery pack Product reference / part number

LOT

Product batch number Obligation for the user to refer to the Instructions for use Part included in a recovery / recycling process

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MRI Guard Agilia and infusion pumps: installation and removal

4.1 Packaging content Warning:  Use ONLY recommended accessories.  Please refer to the 'Ordering information' section for additional information. The MRI Guard Agilia package contains the following elements:  1 MRI Guard Agilia for up to 4 IV infusion pumps: – 1 'Instructions for use' manual. – 1 power cord.  IV Pole for bags and bottles (Pole with cross)  Magnet Indicator’s Battery Pack with two screws (M3-crossed slot) to fasten Battery Pack in housing of MRI Guard Agilia. Information:  If the content of the packaging is not complete, please contact your Fresenius Kabi sales organization.  If some parts are damaged in the packaging, please contact your Fresenius Kabi sales organization.

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4.2 MRI Guard Agilia installation and removal Warning:  All installations and removals have to be performed outside the MR Environment  When used with volumetric pumps and IV bags, respect the recommended distance between IV bags and MRI Guard Agilia with pumps. For more details, please consult the pumps instructions for use.  It is recommended that the ’MRI Guard Agilia: Quick check protocol’ be applied after installation and before use of the device on a new patient. Please refer to the related chapter in this document.

4.2.1 IV Pole Put the IV Pole in the holes between the column of the trolley and housing.

Legend: 3 IV pole

Caution:  Do not install or remove IV pole with infusion bags. 17

4.2.2 Switching on the MRI Guard Agilia Caution:  Use ONLY the power cord supplied by the manufacturer.  This device is intended to be powered ONLY by mains from 100VAC to 240VAC / 50-60Hz.  The MRI Guard Agilia rack is an electrical class I device so must be earthed when connected to an AC power supply with power cord to ensure electrical safety requirements.  When connected to mains power supply, a three-wire power cord (Live, Neutral, Earth) supply must be used with appropriate approvals and requirements by country.  It is imperative that the user checks the quality of the earth (Building electric requirements) and the integrity of power cord.  Do not replace fuses of type other than that specified by Fresenius Kabi.  Disconnect power cord from mains before changing the fuses.  Be sure that the power supply network is insulated, protected and sized to support this medical device equipment.  For additional information related to power requirements, refer to the 'Technical specifications' section in this document. 1. Plug power cord to MRI Guard Agilia’s power connection. 2. Plug power cord into the wall power socket. 3. Check power status indicator is lit in green. Information:  The system status LED located on the upper side switches from yellow to green when the system is ready.

4.2.3 Charging time of the Cap user interface’s battery before first use Caution:  Before starting to use MRI Guard Agilia, connect the power cord to the mains power supply for approximately 15 hours without using the device.

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4.3 Agilia IV infusion pumps installation and removal 4.3.1 Compatible Agilia IV infusion pumps Caution:  Do not try to connect IV pumps other than those recommended.  The MRI Guard Agilia rack has 4 outlets to power Agilia IV infusion pumps devices. These outlets are connected to a functional earth.  An internal switch cuts power on empty positions. This system does not guarantee protection against electric strokes in all cases, so usual caution must be applied. MRI Guard Agilia is ONLY compatible with the following IV infusion pumps from Fresenius Kabi:  Injectomat Agilia  Injectomat MC Agilia  Injectomat TIVA Agilia  Volumat Agilia  Volumat MC Agilia

4.3.2 Installing an Agilia IV infusion pump Warning:  When used with volumetric pumps and infusion bags, respect the installation instructions as detailed in the pump instructions for use (prefer the lowest positions for volumetric pumps).  Do not force during pump installation. If you have to force excessively, do not use the devices and contact your After-Sales Service.  During installation, be sure that IV sets are not squeezed, bent or cut when pump is mounted and door is closed.  To avoid confusion between pumps and the associated infusion lines, we recommend that the infusion set is installed before another pump is mounted on the rack.  Be sure that the pump is correctly mains powered after installation.

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1. Press the door lever to release the door, then pull the lever to fully open the door of the housing.

2. Ensure the pole clamp of the pump is folded up against the pump. Position the Agilia IV infusion pump in front of the rack and slide it carefully on the pump shelf slot.

Legend: 11 Pump shelf

3. Push the pump firmly so that the locking mechanism secures the pump (be sure to hear the 'click').

CLICK

Legend: 10 Pump lock / release

mechanism lever

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