SpaceStation MRI Instructions for Use June 2016

TABLE OF CONTENTS

TA B L E O F C O N T E N T S Patient Safety ...4 Definition of terms and description of symbols...8 Definition of Terms...8 Description of Symbols...10

Chapter 1 Chapter 2 Chapter 3 Chapter 4

SpaceStation MRI in Detail...11 Combination of Pumps within a SpaceStation MRI ...12 Inserting and Removing Individual Pumps in SpaceStation MRI ...13 Cover of SpaceStation MRI ...14 4.1 Operating Elements and Status Display on the cover...15 4.1.1 Display of Battery Condition ...15 4.1.2 Switching On/Off...16 4.1.3 Volume Control...16 4.1.4 Brightness Sensor...16 4.1.5 Battery Maintenance Program...16 4.1.6 Status Display ...17 4.1.7 Self check during Start Up...17

Chapter 5 Chapter 6 Chapter 7 Chapter 8

Positioning in the MR Room – Safety in the MR Environment...18 Magnet Indicator TeslaSpy ...21 Service ...23 Warranty...24 8.1 Maintenance...24 8.2 Cleaning and Disinfecting...24 8.3 Disposal...25 8.4 Rechargeable Batteries ...25

Chapter 9 Chapter 10 Ordering

Technical Data on the SpaceStation MRI ...26 EMC (Electromagnetic Compatibility)...29 ...33

3

PATIENT SAFETY

PATIENT SAFETY Important information concerning the safety of the patient.

w Caution: It is vital to read the accompanying documents on the SpaceStation MRI and the Space pumps. a Read Instructions for Use prior to use. a The user must check functional safety of the SpaceStation MRI. a Check the functions of the SpaceStation MRI before starting operation. a Functional inspection and technical safety checks have to be carried out separately for the Space infusion pumps. a Check the connection to the A/C mains and connect the unit. a Check the mains voltage details on the type (rating) plate.

w Caution: Use of the Space System only by qualified staff. a Use Space System only when you are instructed to work with and familiar with it. a This instruction for use and the B. Braun Perfusor® Space and Infusomat® Space in structions for use form part of the system and are necessary for the proper use of the system. a The instructions for use must be kept near the unit at all times. Proper Use a The SpaceStation MRI is designed for the operation of up to four Space infusion pumps in the MRI unit. The SpaceStation MRI is designed for the therapy of one patient only. The system is used in stationary operation. It is used primarily by doctors and medically trained personnel. a Check if the current software and hardware version of the components of the Space System are the same as this Instructions for Use refers to. a Prevent the SpaceStation MRI trolley from rolling away on horizontal surfaces by using the wheel locks. a The supervision system is inactive if the pumps in the system are switched off. Therefore close the roller clamp or the multiple-path valve at the connection point to prevent any unnoticed backflow occurring. a Only connect the mains cable once the system has been set up. a The SpaceStation MRI has been so conceived that it can be operated with a single mains cable.

w Caution: The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive or flammable environment. a Use only compatible combinations of equipment, accessories, working parts and disposables. a Do not touch simultaneously the monitor, monitor parts and a patient. 4

PATIENT SAFETY

STOP

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Do not position the equipment to make it difficult to operate the disconnection device from supply mains via unplugging the appliance coupler or mains plug. STOP

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SpaceStation MRI, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. To avoid the risk of electric shock, the SpaceStation MRI must only be connected to a supply mains with protective earth. If the integrity of the Protective Earth Conductor or the the protective earth system is in doubt the internal electrical power source is to be used. a Use only original spare parts. Functional safety is only guaranteed if by the manufacturer recommended resp. compatible disposables are used. a Carefully read the Instructions for Use of the infusion pumps and infusion syringe pumps used. a Only operate the infusion and infusion syringe pumps while they are being subjected to regular checks by staff who have been given special instruction. a The user must make sure the pumps and other components of the system are locked correctly. a The connecting leads must be laid so that people do not stumble over them and work with the Space System is not hampered. a Do not place disposable near the connections of the pumps – use hose routings. a Make sure the pumps are inserted and removed correctly. Transport a With max. 4 pumps. Be especially careful when a patient is connected. Avoid external mechanical action! Only for the use of • Infusomat® Space • Infusomat® Space P • Perfusor® Space STOP

Warning: Only use combined with approved devices/accessories by the manufacturer, otherwise this may lead to higher emission or reduced immunity. a Some components have further Instructions for Use or assembly instructions, which need to be observed. a Therapeutic or diagnostic conclusions must not be based exclusively on values displayed on infusion pumps. 5

PATIENT SAFETY

a The Space System should only be operated in areas which are well protected against vibration, dust corrosive and explosive gases, extreme temperatures and humidity. Do not cover the ventilation slots. The equipment must be free of condensate during operation. a In any case of central alarm it is necessary to check which infusion pump caused the alarm. Only the specified alarm caused by the infusion pump is relevant for safety. Direct contact of the connectors of the SpaceStation MRI during operation can lead to malfunction due to electrostatic discharge.

Parallel infusion Compared to single infusions increased bolus volumes and alarm delay times may occur! Therefore: If possible, select low pressure settings. Pay attention to bigger bolus volumes and alarm delay times. When removing sealing, do not let the bolus reach the patient. A bolus reduction may lead to an underdosage of the drug when starting the infusion again. Recommendation: bolus reduction by opening the outward conducting system. T he bolus reduction may lead to dosage variations. Higher personal supervision with critical drugs. Immediate reaction in case of alarm! When switching off a pump temporarily bolus administration is possible due to enrichment of concentration at reduced flow. International safety standards The Space System meets

• IEC/EN 60601-1, • IEC/EN 60601-1-2 and • IEC/EN 60601-2-24 and it is certified with the CE label according to EC directive 93/42/EC. The SpaceStation MRI is especially designed for use in MRI units that make a special contribution to the safety of the patients and operating staff. The device is designed for professional healthcare facility environment according to Figure 3 of IEC 60601-1-2:2014. For some test cases were selected the higher test levels of home healthcare environment. The SpaceStation MRI needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents.

6

PATIENT SAFETY

It is utilised to hold the Infusomat®, Space, Infusomat®, Space P and Perfusor® Space infusion and infusion syringe pumps. The medical professionals will decide on which of these will be used on the basis of their warranted properties and technical data. Please refer to the respective instructions for use of the products listed for details. Transport damage Inspection on delivery. Despite careful packaging, the risk of transport damage cannot be entirely prevented. Upon delivery, please check that nothing is missing. Do not use a damaged device. Contact the service department. Packaging Packages are designed in a way that: electrostatic charges are prevented and batteries on printed boards cannot be discharged.

w Caution: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.

Intended Use of SpaceStation MRI The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients. The product is intended to be used by qualified healthcare professionals. Prescription: In the USA, federal law restricts this device to sale by or on the order of a physician. Contraindication: The SpaceStation MRI is not designed to be used outdoors, in homecare, ambulances, helicopters, air craft, submarines, boats, hyperbaric chambers, explosive or flammable environments.

7

DEFINITION OF TERMS AND DESCRIPTION OF SYMBOLS

DEFINITION OF TERMS AND DESCRIPTION OF SYMBOLS Definition of Terms MR Scanner / MRI Scanner / MR Imaging System / MRI Unit / MR Equipment: Medical electrical equipment for examination of patients by Magnetic Resonance Imaging (MRI). MR Examination: Process of acquiring data by Magnetic Resonance (MR) from a patient with a MR Scanner. Magnet Room / MRI Room / MRI Scanner Room / MRI Procedure Room / MR Environment: Room shielded from high frequencies, in which the MR Scanner is situated. The MR Environment is the dimensional volume of space surrounding the MR magnet (MR Scanner) that contains both the Faraday shielded volume and the 0.50mT field contour (5 gauss (G) line). This volume is the region in which an item might pose a hazard from exposure to the electromagnetic fields produced by the MR Equipment (MR Scanner) and accessories. MR Control room: The room immediately adjacent to the magnet room, from where the user (radiographer) controls the examination. MR Safe: A device that poses no known hazards resulting from exposure to any MR Environment. MR Conditional: A device with demonstrated safety in the MR Environment within defined conditions (The SpaceStation MRI is MR Conditional) MR Unsafe: A device which poses unacceptable risks to the patient, medical staff or other persons within the MR Environment mT (MilliTesla): Unit of magnetic flux density. System / Space System: SpaceStation MRI (including trolley) and Space pumps. SpaceStation MRI: MRI system rack (incl. trolley) for maximum four Space Infusion Pumps. Space Pumps: Volumetric and syringe pumps of the B. Braun Space series 8

DEFINITION OF TERMS AND DESCRIPTION OF SYMBOLS

TeslaSpy®: Integrated, independent monitoring of the magnetic field for optimum placement of the SpaceStation MRI in the magnet room. An optical and audible alarm is triggered if the permitted flux density is exceeded.

9

DEFINITION OF TERMS AND DESCRIPTION OF SYMBOLS

Description of Symbols Symbol

Description Follow instruction for use. Consult instruction for use. Type CF unit with defibrillation protection Protection class II device Symbol indicating separate collection for electrical and electronic equipment (2002/96/EC) x

CE mark compliant to Directive 93/42/EEC Temperature limit (see Chapter 9 Technical Data on the SpaceStation MRI) Humidity limitation (see Chapter 9 Technical Data on the MR Scanner SpaceStation MRI) Z

Atmospheric pressure limitation (see Chapter 9 Technical Data on the SpaceStation MRI) examination table Caution

LOT

Batch number

SN

Serial number x

MR conditional

SpaceStation MRI is MR Conditional

10

SPACESTATION MRI IN DETAIL Chapter 1

SPACESTATION MRI IN DETAIL

Operator panel and status display for battery operation Door inlet guide holes for infusion tubings Release button for the pumps Door outlet guide holes for infusion tubings

Alarm display for the pumps

Rear side: Mains voltage input and Potential Equalization Conductor

Desktop surface for pumps and drawer for accessories.

Tubing guide for Infusomat® Lines

11

COMBINATION OF PUMPS WITHIN A SPACESTATION MRI Chapter 2

COMBINATION OF PUMPS WITHIN A SPACESTATION MRI The following pumps can be combined within a SpaceStation MRI: - Maximum 4 pumps; Infusomat® Space or Perfusor® Space - Infusomat® Space (volumetric pumps) cannot use a drip sensor in SpaceStation MRI

w Caution: The SpaceStation MRI is not designed for other pumps than Infusomat® Space or Perfusor® Space. Details to the approved pumps see Chapter: Ordering. Recommendation: When using Infusomat® Space and Perfusor® Space together, position the Infusomat® Space in the upper slots for better handling of the infusion lines into the infusion line guide above and place the Perfusor® Space in the lower slots.

12

INSERTING AND REMOVING INDIVIDUAL PUMPS IN SPACESTATION MRI Chapter 3

INSERTING AND REMOVING INDIVIDUAL PUMPS IN SPACESTATION MRI w Caution: Before inserting a pump please ensure the vertical position of the side rotary knob. The guide rails of the SpaceStation MRI must engage in the guide grooves of the pump. The pump is then pushed with light pressure into the SpaceStation MRI. The pump is automatically locked in the system. The locking is to be recognized by the horizontal position of the side rotary knob.

To release, turn the knob clockwise in the vertical position and remove the pump. After release the pump is held in the SpaceStation MRI by the guide rails, but can drop easily due to strong vibrations or during transport.

w Caution: If a SpaceStation MRI is used to transport infusion pumps make sure that the pumps are correctly seated in the system.

13

COVER OF SPACESTATION MRI Chapter 4

COVER OF SPACESTATION MRI All the necessary operating and display components are integrated in the lid of the SpaceStation MRI. The cover is equipped on its front side with a large and very easily readable status and alarm display. All the status and alarm conditions of the pumps within the system, as well as of the pumps themselves are displayed. The following conditions can be indicated: Green -> OK, at least one pump is in operation. Yellow -> Prealarm in a pump within the system. Red

-> Alarm of a pump in the system

Details of the individual prealarms and alarms are to be found in the respective operating instructions of the pumps. A rechargeable battery is used in the SpaceStation MRI. This rechargeable battery ensures complete system functionality during transport and when the voltage supply is interrupted. Besides this, a loudspeaker is integrated in the unit to sound the alarms from the pumps. The volume can be adjusted in four steps using the controls on the side.

w Caution: The environmental noise within the MRI unit is much louder during the examination than the noise made by either the Space pumps or the SpaceStation MRI. When spending time in the magnet room, ear protection must be worn during examinations.

w Caution: Users should usually remain outside in the control room during examinations because of the high noise level and due to possible electromagnetic burdens. The magnet room is soundproof, so any acoustic alarms will be inaudible! Watch out for any optical alarms from the pumps. The optical alarms at the pumps are decisive. We recommend that the SpaceStation MRI is always positioned in such a way that the alarm displays at the front can be seen at any time.

14

COVER OF SPACESTATION MRI Chapter 4

4.1

Operating Elements and Status Display on the SpaceCover

4-stage volume adjustment for SpaceStation MRI

On/Off switch for SpaceStation MRI

Status display for SpaceStation MRI

Display of battery condition

4.1.1

Three-coloured LED, green, yellow and red for battery capacity display

Display of Battery Condition

The display elements indicate the condition of the rechargeable battery in the SpaceStation MRI. The following conditions are indicated. Battery condition

LED left

LED middle

LED right

> 75% capacity > 50% capacity > 25% capacity < 25% capacity < 30 min operating time

flashing

< 3 min operating time

flashing

Maintenance required Maintenance active (capacity > 75%)

blinkt

Maintenance active (capacity > 50%)

flashing

Maintenance active (capacity > 25%)

flashing

Maintenance active (capacity < 25%)

flashing

Battery pre alarms and end alarms can be acknowledged with the "+" and "-" volume control buttons. Thereby the audible alarm is prevented, the optical alarm is still 15

COVER OF SPACESTATION MRI Chapter 4 displayed. Battery alarms are acknowledged automatically when the system is reconnected to the mains..

4.1.2

Switching On/Off

The on/off switch only functions when the system is in battery mode. In case the system is connected to the mains, it is always switched on and the pumps employed are supplied with mains voltage.

w Caution: If the system is not needed and is also not connected to the A/C mains it should be switched off. The on/off switch must be pressed for three seconds to switch off. The status diode will flash for approx. 5 seconds and will then go out.

4.1.3

Volume control

The volume of the loudspeaker installed can be controlled with the buttons "+" and "-". The setting is made in 4 steps and after every new step a signal is sounded at the new volume. When the maximum or minimum volume is reached, a deep tone is heard. The last volume setting is saved when the system is switched off.

4.1.4

Brightness Sensor

Every SpaceStation MRI is equipped with a brightness sensor that adapts the brightness of the alarm display in the cover to the environment. The brightness cannot be adjusted manually.

4.1.5

Battery Maintenance Program

To guarantee maximum battery capacity and at the same time a long service life, a so-called battery maintenance program is integrated in the system. The battery maintenance is displayed automatically dependent on the operation of the unit. The battery maintenance program can only be initiated when the system is connected to the A/C mains. The battery maintenance can be triggered separately for SpaceStation MRI and SpaceCom batteries. The status diode of the battery concerned is illuminated when maintenance is needed. The maintenance program is started by pressing the On/Off button and the "-" button with the SpaceCom (or the "+" button with the SpaceStation MRI) at the same time. The batteries will be recharged when the maintenance program has been completed.

w Caution: When battery maintenance is carried out, the unit should not be used for transport purposes because the complete battery running time will no longer be guaranteed.

16

COVER OF SPACESTATION MRI Chapter 4

4.1.6

Status display The system is operated with A/C mains voltage The system is operated by battery flashing

Wrong configuration, check the system setup Unrecoverable error, exchange cover

4.1.7

Self check during Start Up

During the start up of the SpaceStation MRI a self check is started automatically. The three LEDs at the front will be tested in the sequence: red, yellow, green and after this the status indicators of SpaceStation MRI are tested. If an alarm LED on the front is defective, the yellow alarm LED is constantly on (if it can) and the status display on the side will be illuminated (red). In this case, the SpaceStation MRI must not be used.

17

POSITIONING IN THE MR ROOM – SAFETY IN THE MR ENVIRONMENT Chapter 5

POSITIONING IN THE MR ROOM – SAFETY IN THE MR ENVIRONMENT The SpaceStation MRI may be operated at a maximum magnetic field of 20mT / 200G. Depending on the different MR Scanners this means a distance of approximately 1.5m / 5ft to the opening of the bore (based on actively shielded 3T scanner). Please consult the Technical Description from the Manufacturer of your MR Scanner for details regarding the spatial distribution of surrounding field and safe working distance. For exact positioning of the SpaceStation MRI please use the integrated Magnet Indicator TeslaSpy (see Chapter 6). x

MR Scanner

Z examination table

x

SpaceStation MRI is MR Conditional

Preparations and general instructions: a The pumps may be used only inserted the SpaceStation MRI in the Magnet Room. a Inserting and Removing Individual Pumps in SpaceStation MRI in the MR Control Room (outside the Magnet Room) (see Chapter 3) a The pumps have to be locked in the integrated rack of SpaceStation MRI (see Chapter 3) a The infusion lines (tubings) have to be inserted in the tube guides. By closing and locking the door of SpaceStation MRI do not squeeze the infusion lines. (see Chapter 3) a Store only antimagnetic components in the drawer of the trolley. 18

POSITIONING IN THE MR ROOM – SAFETY IN THE MR ENVIRONMENT Chapter 5 a There have to be enough infusion liquid in bag/bottle or syringe for the expected examination time of patient in the MR Scanner. a There have to be enough battery capacity for the expected examination time of patient in the MR Scanner in case there is no mains power supply in the Magnet Room. a The SpaceStation MRI should always be connected to mains power supply to charge the batteries (during storage, in MR Control Room, in Magnet Room). Exception: During movement of SpaceStation MRI the mains cable should be disconnected. a The mains cable must neither be subject to tension nor be lying on the floor in a position where it can be tripped over. a Please push the trolley carefully and look out for any possible obstacles on the floor. a The drawer has to be closed and the door has to be closed and locked during any movement of SpaceStation MRI. Placement in the Magnet Room: a Do not place the SpaceStation MRI any closer than 20mT / 200G (1.5m / 5ft) to the MR Scanner a Never place the SpaceStation MRI immediately next to the magnet bore of the MR Scanner. a Parts of the pumps and the SpaceStation MRI consist of ferromagnetic materials. This could lead to a magnetic attraction in a higher magnetic field than 20mT / 200G. a The pumps must not be put down on the examination table of the MR Scanner. a Carefully move the SpaceStation MRI closer to the MR Scanner and observe the Signals of Magnet Indicator TeslaSpy (details see also Chapter 6). a Fix the position of the SpaceStation MRI by locking the brakes of castors (to avoid any accidentally pushing away of the trolley). a It is recommended to mark the critical magnetic field on the floor. a Connect the mains cable in a straight line and ensure that no loops arise. Do not roll up the mains cable. a Do not catch up and squash the infusion lines by moving (or removing) the patient on the examination table into (or out of) the MR Scanner. a The shielding of SpaceStation MRI ensures MR Images without artefacts, but does not reduce the magnetic field to the inserted pumps. MR Examination / MR Scan: a The door of SpaceStation MRI has to be closed and locked during MR examination to avoid artefacts on MR Images. - The door can be opened between the scans/sequences (if MR Scanner is not scanning). - In urgent cases the door can be opened at any time (even if MR Scanner is scanning). This will lead not to malfunctions of the pumps, but this could lead to artefacts on the MR Images. Maybe the MR Scan has to be repeated in this case.

19

POSITIONING IN THE MR ROOM – SAFETY IN THE MR ENVIRONMENT Chapter 5

MR Scanne

a The environmental noise of the MR Scanner is much louder during the examination than the noise made by either the Space pumps or the SpaceStation MRI. During Z MR Examination an ear protection should be worn. Auditory Alarms cannot be examination table heard during examinations. Watch out for any visual alarm! a The visual alarms are decisive. We recommend that the SpaceStation MRI is always positioned in such a way that the alarm displays at the front can be seen at any time. Conditions for use the MR Environment / Magnet Room on SpaceStation MRI (Marking) Symbol Description x MR Scanner: 1.5T; 3.0T MR Conditional (according ASTM F 2503) SpaceStation MRI is MR Conditional Not intended for use in the Magnet Bore of MR Scanner ≤ 20 mT / 200 Gauss Distance to MR Scanner: ≥ 1,5m Magnetic Field in MR Environment: ≤ 20 mT / 200 Gauss ≥ 1.5 m

w 4

Magnet Indicator

Caution! Observe the Magnet Indicator TeslaSpy. Obligation for the user to consult the Instructions for use for important warnings and precautions. Lock the brakes of the four castors.

20

MAGNET INDICATOR TESLA SPY Chapter 6

MAGNET INDICATOR TESLA SPY a The Magnet Indicator TeslaSpy is an integrated instrument for measuring the magnetic flux density. a The display unit (LED´s) is located on the device itself, at the top left, below the label (see below). a The TeslaSpy is an aid that allows the SpaceStation MRI to be operated as close as possible to the MR Scanner (while still being safe). a The ON/OFF switch of TeslaSpy has to be pushed (activated) once before first use. Do no switch it off after use. The TeslaSpy is power supplied by a rechargeable battery. In case of an empty battery the device is automatically turning off. After connecting to the Mains Power supply the TeslaSpy will re-start again automatically (No further push of ON/OFF switch is necessary). a Signals of TeslaSpy:

1

3

4 Position ON/OFF Switch of TeslaSpy on lower surface of cover

2

5

A flashing green LED indicates that the TeslaSpy is operational.

#

Positioning / Indication

1

Normal operation; Magnetic field < 20 mT

Priority

Magnetic field 20 – 40 mT

Display

Instruction

Low

The SpaceStation MRI is Green LED flashes each located outside the critical magnetic field. 2 seconds. Safe operation is ensured

Medium

Yellow LED The critical magnetic field is reached. flashes each 1.5 seconds The SpaceStation MRI has and speaker to be removed back to sounds an green area and not to be moved closer to the MR auditory signal. Scanner!

w Caution: 2

Color

21