SpaceStation
and SpaceCom
Instructions for Use
GB Valid for Software 695F
CONTENTS
Patient Safety |
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4 |
Chapter 1 |
The SpaceStation in Detail................................................................................ |
8 |
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1.1 |
Fastening a Single SpaceStation ................................................................................................. |
9 |
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1.2 |
Assembly and Disassembly of Pillars ........................................................................................ |
10 |
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1.3 |
Combining Individual SpaceStations ....................................................................................... |
10 |
Chapter 2 |
Combination of Pumps within a SpaceStation.......................................... |
13 |
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Chapter 3 |
Inserting and Removing IndividualPumps ................................................. |
14 |
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Chapter 4 |
SpaceCover Standard...................................................................................... |
15 |
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Chapter 5 |
SpaceCover Comfort........................................................................................ |
15 |
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5.1 |
Operating Elements and Status Display on the SpaceCover ............................................... |
16 |
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5.1.1 Display of Battery Condition .......................................................................................... |
16 |
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5.1.2 Switching On/Off ............................................................................................................. |
17 |
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5.1.3 Volume Control ................................................................................................................. |
17 |
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5.1.4 Brightness Sensor ............................................................................................................. |
17 |
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5.1.5 Battery Maintenance Program ...................................................................................... |
18 |
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5.1.6 Status Display ................................................................................................................... |
18 |
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5.1.7 Self check during start up ................................................................................................ |
18 |
Chapter 6 |
Interfaces for Data Communication............................................................. |
19 |
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6.1 |
Intended Use................................................................................................................................. |
19 |
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6.2 |
The connectors of SpaceCom .................................................................................................... |
20 |
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6.3 |
Status Displays ............................................................................................................................ |
20 |
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6.4 |
Inserting and removing battery for SpaceCom....................................................................... |
21 |
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6.5 |
Configuration SpaceCom Interfaces......................................................................................... |
21 |
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6.6 |
SpaceOnline, the SpaceCom Web Server Application............................................................ |
21 |
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6.6.1 Setting of a network connection.................................................................................... |
22 |
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6.6.2 Login.................................................................................................................................... |
22 |
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6.7 |
Status............................................................................................................................................. |
23 |
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6.8 |
Service............................................................................................................................................ |
24 |
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6.9 |
Configuration................................................................................................................................ |
24 |
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6.9.1 User Settings...................................................................................................................... |
24 |
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6.9.1.1 Change Password................................................................................................. |
25 |
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6.9.1.2 Change Username................................................................................................ |
25 |
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6.9.1.3 Change access authorization............................................................................. |
25 |
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6.9.2 WLAN and Ethernet Settings .......................................................................................... |
26 |
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6.9.3 BCC Protocol Settings ...................................................................................................... |
26 |
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6.9.4 Battery Settings................................................................................................................. |
27 |
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6.9.5 Database Settings............................................................................................................. |
27 |
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6.9.6 Time synchronization via SNTP....................................................................................... |
27 |
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6.10 |
Wireless LAN................................................................................................................................. |
27 |
Chapter 7 |
Proposal data.................................................................................................... |
28 |
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7.1 |
General ............................................................................................................................. |
30 |
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7.2 |
Working with proposal data....................................................................................................... |
30 |
Chapter 8 |
Datalogger ................................................................................................ |
31 |
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Chapter 9 |
Service ................................................................................................ |
32 |
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Chapter 10 |
Guarantee.......................................................................................................... |
33 |
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10.1 Maintenance ................................................................................................................................ |
33 |
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10.2 Hygienics / Disposal .................................................................................................................... |
33 |
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10.3 Rechargeable Batteries .............................................................................................................. |
34 |
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Chapter 11 |
Technical Data.................................................................................................. |
35 |
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11.1 |
B. Braun SpaceStation without B. Braun SpaceCom ............................................................ |
35 |
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11.2 |
B. Braun SpaceStation with B. Braun SpaceCom .................................................................. |
36 |
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11.3 |
B. Braun SpaceCover comfort ................................................................................................... |
37 |
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11.4 |
B. Braun SpaceCover standard .................................................................................................. |
38 |
Ordering |
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............................................................................................................. |
39 |
3
PATIE NT SAFETY
PA TIE NT SAF ETY
Important Information and Notes for Patient Safety
w Attention: Consult accompanying documents!
aRead Instructions for Use prior to use.
aThe user must check functional safety and integrityof the SpaceSystem.
aPriorto use check functions of the Space System: Validonly for Space System.*
aFunctional tests and Technical Safety Checks have to be carried out separately for all additional connected devices.
aCheck and set up connections to mains and furtherplug connections.
aCheck if mains voltage corresponds to indication on the type plate!
aWhen connected, check staff call (simulate alarm,staffcall must react).
Warnings:
aUse of the Space System only by qualified staff.
aUse SpaceSystem only when you are instructedto work with and familiar with it.
aThis Instructions for Use is part of the Space Systems necessary for proper use.
aThe Instructions for Use have to be available at the Space System.
Proper Use:
aThe modularSpace System is made for treatmentof a singlepatient. It is especially designedfor use on Intensive Care Units and OperatingTheatres. The Space System is used in hospital. Operation mainly by physicians and medically qualified nursing staff.
aCheck if the current software and hardware versionof the components of the Space System are the same as this Instructions for Use refersto.
aAt fm mobil, accessory for mobile use, it is not permittedto use short stands, as the centre of gravity of the Space System may change.
aInsert receptacle suspension of the fm mobilbeforetransport.
Check stability and secure position, especially when fastening the system to the fm mobil.
aPrevent the fm mobil from rolling away on horizontalsurfaces by using the locking device. If thereis an incline of more than 5°, additionallocking is necessary.
aWhen the pumps in the Space System are switched off the control systems are not active. Therefore, close roller clamp or selector valve at the connection pointto prevent uncontrolled backflow.
aDo not plug the power supply lead into the socket beforethe wholesystem is built up.
aThe SpaceSystem is designed for operation with a singlepower supplyconnection per pillar.
aAll configurations must comply with IEC/EN 60601-1-1.
aPossible explosion hazard if used in presence of flammableanesthetics!
aUse only compatible combinations of equipment, accessories, working parts and disposables.
aUse only original spare parts. Functional safety is only guaranteed if by the manufacturer recommended resp. compatibledisposables are used.
4 
PATIENT SAFE TY
aRead carefully Instructions for Use of the infusion pumps and infusion syringe pumpsused.
aApplicationof infusion and infusion syringepumpsonly underregularly supervision by speciallytrained staff.
aThe user must make sure the pumps and other components of the system are locked correctly.
aDo not deposit things on the pumps. Avoid leaningon the pumps!
aThe connecting leads must be laid so that people do not stumbleover them and work with the Space System is not hampered.
aDo not place disposable near the connectionsof the pumps– use hose routings.
aMake sure the pumps are inserted and removed correctly.
Transport:
aWith max. 4 pumps. Be especially careful when a patient is connected. Avoid external mechanical action!
Only for use of:
aInfusomat®Space
aInfusomat®Space P
aPerfusor® Space
aSpaceControl
aSpaceCom
aSome components have further Instructions for Use or assembly instructions, which need to be observed.
aTherapeutic or diagnostic conclusions must not be based exclusively on values displayed on infusion pumps or data available via interfaces.
aThe SpaceSystem should only be operated in areas which are well protected againstvibration, dust corrosive and explosive gases,extreme temperatures and humidity.To guarantee sufficient air circulation for cooling the system, there should be at least 5 cm of clear space around the system. Do not cover the ventilation slots. The equipment must be free of condensate during operation.
aWhen equipment with high electro-magnetic radiationis used at the same time (e.g. digital telephones, X-ray apparatus, MRI, etc.) interference may occur.This may lead to display trouble or implausible values may be indicated. If these problems are due to electro-magnetic interferences, the followingmeasures may help to avoid or
solve them:
a Avoid using devices which are not necessaryfrom the medical pointof view (e.g.
mobiletelephones).
a Extend distance between source of interferenceand the medical product. a Alter position of power supply leads, connectionleads and electrodes.
aThe EMC-limits (electro-magnetic compatibility) accordingto IEC/EN60601-1-2 and IEC/EN60601-2-24 are maintained. If the equipment is operated in the vicinity of other equipment which may cause high levels of interference (e.g. HF surgical equipment,nuclear spin tomography units, mobiletelephones) maintainthe recommended protective distances for these devices.
5
PATIE NT SAFETY
aThe SpaceSystem should not be exposed to excessivemagnetic fields (e.g.in an MRI room).If necessary,longer infusion lines can be used. When using a defibrillator,precautions must be observed whichcan be foundin the documentation for the defibrillator.
aFor the safe use of Space infusion pumps in MRI the SpaceStationMRI is recommended.
aIn any case of central alarm (e.g. from staff call)it is necessary to check which infusion pump caused the alarm. Only the specifiedalarm caused by the infusion pump is relevant for safety.
Direct contact of the connectors of the SpaceStationduringoperation can lead to malfunction due to electrostatic discharge.
Parallel infusion:
Compared to single infusions increased bolus volumesand alarm delaytimes may occur!
Therefore:
If possible, select low pressure settings.
Pay attention to bigger bolus volumes and alarmdelaytimes. When removing sealing, do not let the bolus reachthe patient.
A bolus reduction may lead to an underdosage of the drug when starting the infusion again.
Recommendation: bolus reduction by opening the outwardconducting system. The bolusreduction may lead to dosage variations.
Higher personal supervision with critical drugs. Immediate reaction in case of alarm!
When switching off a pump temporarily bolus administrationis possibledue to enrichment of concentration at reduced flow.
International safety standards:
The Space System complies with:
aIEC/EN60601-1,
aIEC/EN60601-1-1,
aIEC/EN60601-1-2 as well as
aIEC/EN60601-2-24
and is CE marked in compliance with EU-Directive93/42.
B. BraunMelsungen AG is certified according to DIN EN ISO 9001and DIN EN ISO 13485.
This certificationalso includes maintenance and service.
The visible LED’s comply to class 1 LED products according to IEC/EN60825-1.
The B. BraunSpace System is a flexible docking and communication system for the medical workplace, in particular the intensive medicalcare, which substantially contributes to the safety of its patients.
It serves the perspicuous accommodation of the infusionand infusion-syringe pumps Infusomat®Space, Infusomat® Space P and Perfusor®Space, whoseconcrete applicationis the medical professional decides on basedupon guaranteed
6 
PATIENT SAFE TY
characteristics and technical data. The pillar and mounting system synchronized system components enables the individualized workplace design.
The SpaceSystem is flexible due to fast and space saving assembly and disassembly as well as the possibility to use it as a mobile, wall or ceiling unit.
Fur furtherdescriptions as well as assembly resp. disassemblyplease see this Instructionsfor Use.
Transport damages:
Inspection on delivery.Despite careful packaging,the risk of transportdamage cannot be entirely prevented. Upon delivery,please checkthat nothingis 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.
7
TH E SPAC ES TATION IN DE TAIL
Chapter 1
TH E SPA CEST AT IO N IN DETA IL
SpaceStationserves to accommodate up to four infusion and infusion syringe pumps. The single SpaceStations can be assembled to form one or up to three pillars which are separated from each other. The individual pillars requiretheirown mainssupplyand are interconnected with each other via special extension cables. Every pillar must be closed with a cover, SpaceCover Standard or Comfort, to ensure safe and complete system functionality.
Connectorfor further
SpaceStationsor
SpaceCovercomfort;
F5
Connectorfor Space pump.Data linesand 12 V voltagesupply;
F2A to F2D
Centralloudspeaker, only containedin SpaceCovercomfort
Leverto release universalclamp
Fixtureof universal clampSP,rotatable for attachmentto wall railsand infusion poles
Mainspowerinput;
F1A
8 
Mainsvoltageoutletto the next SpaceStation;
F1B
Guiderailsfor the individualpumps
Connectionfor extensioncable for furtherSpaceStation;F4
Connectionfor staffcall,PCA button,ConnectionLead SP 12V and servicecable;F3
w Attention:Do not connect the PowerSupplySP to this connector
THE SPAC ES TATI ON IN DETA IL
Chapter 1
Rotaryknob to unlocksinglepumps. Lockinghappens automaticallywhen the pump is pushed in.
Hose routingsfor infusiontubing
CoverSpaceCover;must alwayscoverthe uppermostsegment.Servesat the same time as carryinghandlefor a SpaceStation.
Lock/unlockof upperSpaceStation or SpaceCover
w Attention: Every SpaceStation or one pillar consisting of several SpaceStations must be covered with SpaceCover standard or comfort.The SpaceCover protects the upper connections from humidity and damage and ensures perfect system functionality.The SpaceStation and the individualpump are connected to each other via the connectors F2A to F2D. The plugs are to be protected from damageand humidity.
1.1 Fastening a Single SpaceStation
Every singleSpaceStation can be attached to infusionpolesand vertical tubes, e.g. pendantssuspension, as well as to horizontal wall rail systems accordingto EN 1789 withoutneed of any further adapters or assemblyauxiliaries. The rear universal clamp can be rotated and has a quick-action mechanism.By pullingthe release ring back, the slidecan be moved freely and prepositioned. Now the SpaceStation can be definitely fixed by means of the set screw.
w Attention: Make sure that the SpaceStation is fastened correctly and safely after
9
TH E SPAC ES TATION IN DE TAIL
Chapter 1
By pullingthe releasering back,the slidecan be moved freelyfor prepositioning.
assembly. Do not use tools to tighten the screw !
To release, first loosen the clamp by turning the adjusting knob half and then pull the release ring in order to loosen the pole clamp usingthe quickgripping mechanism.
1.2 Assembly and Disassemblyof Pillars
The upper segment is pushed on the lower segment from the front and fixed with the locking in the lower segment.
To release, move the locking button in the correspondingpositionand take out the upper segment to the front.
w Attention: Every single SpaceStation must be fixed to a fastening tube by means of a fixationclamp.
1.3 Combining Individual SpaceStations
To mount one or multiple pillars the single SpaceStationscan be assembled easily and without any difficulties without requiring any special assemblytools.
The admissible combinations are listed in the following table:
10 
THE SPAC ES TATI ON IN DETA IL
Chapter 1
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1Pillar |
2 Pillars |
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3 Pillars |
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A |
A |
B |
A |
B |
C |
SpaceCover Comfort |
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1 |
1 |
(1) |
1 |
(1) |
(1) |
SpaceCover Standard |
|
(1) |
(1) |
1 |
(1) |
1 |
1 |
SpaceStation |
|
1 … 6 |
1 … 5 |
1 … 5 |
1 … 4 |
1 … 4 |
1 … 4 |
Restriction |
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A ≤ 6 |
∑ A + B ≤ 6 |
∑ A + B + C ≤ 6 |
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(x) alternativeusagepossible |
A,B,Cnumberof SpaceStationin one pillar |
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w Attention: Other configurations, such as more than three pillarsor exceedingthe number of SpaceStations within a pillar, are not permittedand result in
configuration error.
If a system consists of several pillars, these shouldbe arrangedlogically and physically from left to right.
Pillar1(A) |
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Pillar2(B) |
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Extensionlead SP 60 or 120 cm. The lead is connectedto F4 in pillar1 and then to F3 in pillar2.
w Attention: If the pillars will not be connected as described above, interchangingF4 and F3, there is a wrong topologicalrepresentation in SpaceOnlineand wrong addressing in the BCC protocol.
11
TH E SPAC ES TATION IN DE TAIL
Chapter 1
Every single pillar must be covered with a SpaceCover standard or SpaceCover comfort. If with a two or three pillars build up and only one SpaceCover comfort is used in this combination all alarms and status information are displayed at this Cover. In case every pillar is covered with a SpaceCover comfort the statusand alarminformation are shown at the corresponding cover.
Pillar1(A) |
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Pillar2(B) |
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Pillar3(C) |
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Extensionlead SP 60 or 120 cm. The lead is connectedto F4 in pillar 1 and then to F3 in pillar2. Pillar2 and 3 are interconnectedwith each othervia F3 and F4.
12 
COMB INATI ON OF PUMP S WITHI N A SP ACESTATION
Chapter 2
CO MBIN ATIO N OF PU MPS WITHIN A
SPA CEST AT IO N
The following pumps and modules can be combined within a SpaceStation.:
•4 pumps; Infusomat® or Perfusor® Space and optionalSpaceCom
•3 Space pumps and 1 SpaceControl and optionalSpaceCom
•2 Space pumps and 2 SpaceControl and optionalSpaceCom
•4 Space pumps and 1 SpaceControl, attached to the lowest pump in the system and optional SpaceCom.
w Attention: Danger of tipping !
An operation as tabletop unit is not allowed.
Operation is only allowed if mounted on a stable infusion pole.
w Attention: The operation of a fifth pump mounted under the lowest pump in the system is not allowed.
13
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