B Braun SpaceStation, SpaceCom Service manual
SpaceStation
and SpaceCom
Instructions for Use
GB
Valid for Software 695F
CONTENTS
Patient Safety ..............................................................................................................................4
Chapter 1 The SpaceStation in Detail................................................................................8
Chapter 2 Combination of Pumps within a SpaceStation ..........................................13
Chapter 3 Inserting and Removing Individual Pumps .................................................14
Chapter 4 SpaceCover Standard......................................................................................15
Chapter 5 SpaceCover Comfort........................................................................................15
Chapter 6 Interfaces for Data Communication.............................................................19
Chapter 7 Proposal data....................................................................................................28
Chapter 8 Datalogger ................................................................................................31
Chapter 9 Service ................................................................................................32
Chapter 10 Guarantee..........................................................................................................33
Chapter 11 Technical Data..................................................................................................35
Ordering .............................................................................................................39
.1 Fastening a SingleSpaceStation .................................................................................................9
1
1.2 Assembly and Disassembly of Pillars ........................................................................................10
1.3 Combining Individual SpaceStations .......................................................................................10
5.1 Operating Elements and Status Displayon the SpaceCover ...............................................16
5.1.1 Display of Battery Condition.......................................................................................... 16
5.1.2 Switching On/Off .............................................................................................................17
5.1.3 VolumeControl .................................................................................................................17
5.1.4 Brightness Sensor .............................................................................................................17
5.1.5 Battery Maintenance Program ......................................................................................18
5.1.6 Status Display ...................................................................................................................18
5.1.7 Self check during start up ................................................................................................18
6.1 Intended Use.................................................................................................................................19
6.2 The connectors of SpaceCom ....................................................................................................20
6.3 Status Displays ............................................................................................................................20
6.4 Inserting and removingbattery for SpaceCom.......................................................................21
6.5 Configuration SpaceCom Interfaces.........................................................................................21
6.6 SpaceOnline, theSpaceCom Web ServerApplication............................................................21
6.6.1 Setting of a network connection....................................................................................22
6.6.2 Login....................................................................................................................................22
6.7 Status.............................................................................................................................................23
6.8 Service............................................................................................................................................24
6.9 Configuration................................................................................................................................24
6.9.1 User Settings......................................................................................................................24
6.9.1.1 ChangePassword.................................................................................................25
6.9.1.2 ChangeUsername................................................................................................25
6.9.1.3 Changeaccess authorization.............................................................................25
6.9.2 WLAN and Ethernet Settings..........................................................................................26
6.9.3 BCCProtocol Settings......................................................................................................26
6.9.4 Battery Settings.................................................................................................................27
6.9.5 Database Settings.............................................................................................................27
6.9.6 Time synchronization via SNTP.......................................................................................27
6.10 Wireless LAN.................................................................................................................................27
7.1 General .............................................................................................................................30
7.2 Working with proposaldata.......................................................................................................30
10.1 Maintenance ................................................................................................................................33
10.2 Hygienics/ Disposal ....................................................................................................................33
10.3 Rechargeable Batteries ..............................................................................................................34
11.1 B. Braun SpaceStation withoutB. Braun SpaceCom ............................................................35
11.2 B. Braun SpaceStation with B. Braun SpaceCom ..................................................................36
11.3 B. Braun SpaceCovercomfort ...................................................................................................37
11.4 B. Braun SpaceCoverstandard ..................................................................................................38
3
PATIENT SAFETY
PATIEN T SAFE TY
Important Information and Notes for Patient Safety
w Attention: Consult accompanying documents!
a Read Instructions for Use prior to use.
a The user must check functional safety and integrity of the Space System.
a Prior to use check functions of the Space System: Valid only for Space System.*
a Functional tests and Technical Safety Checks have to be carried out separately for
all additional connected devices.
a Check and set up connections to mains and further plug connections.
a Check if mains voltage corresponds to indication on the type plate!
a When connected, check staff call (simulate alarm, staff call must react).
Warnings:
a 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 Instructions for Use is part of the Space Systems necessary for proper use.
a The Instructions for Use have to be available at the Space System.
Proper Use:
a The modular Space System is made for treatment of a single patient. It is especially
designed for use on Intensive Care Units and Operating Theatres. The Space System
is used in hospital. Operation mainly by physicians and medically qualified nursing
staff.
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 At fm mobil, accessory for mobile use, it is not permitted to use short stands, as the
centre of gravity of the Space System may change.
a Insert receptacle suspension of the fm mobil before transport.
Check stability and secure position, especially when fastening the system to the fm
mobil.
a Prevent the fm mobil from rolling away on horizontal surfaces by using the locking
device. If there is an incline of more than 5°, additional locking is necessary.
a When 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 point to
prevent uncontrolled backflow.
a Do not plug the power supply lead into the socket before the whole system is built
up.
a The Space System is designed for operation with a single power supply connection
per pillar.
a All configurations must comply with IEC/EN 60601-1-1.
a Possible explosion hazard if used in presence of flammable anesthetics!
a Use only compatible combinations of equipment, accessories, working parts and
disposables.
a Use only original spare parts. Functional safety is only guaranteed if by the
manufacturer recommended resp. compatible disposables are used.
4
PATIENT SAFETY
a Read carefully Instructions for Use of the infusion pumps and infusion syringe
pumps used.
a Application of infusion and infusion syringe pumps only under regularly supervision
by specially trained staff.
a The user must make sure the pumps and other components of the system are locked
correctly.
a Do not deposit things on the pumps. Avoid leaning on the pumps!
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 use of:
a Infusomat® Space
a Infusomat® Space P
a Perfusor® Space
a SpaceControl
a SpaceCom
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 or data available via interfaces.
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. 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.
a When equipment with high electro-magnetic radiation is 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 following measures may help to avoid or
solve them:
a Avoid using devices which are not necessary from the medical point of view (e.g.
mobile telephones).
a Extend distance between source of interference and the medical product.
a Alter position of power supply leads, connection leads and electrodes.
a The EMC-limits (electro-magnetic compatibility) according to IEC/EN 60601-1-2
and IEC/EN 60601-2-24 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, mobile telephones) maintain the
recommended protective distances for thesedevices.
5
PATIENT SAFETY
a The Space System should not be exposed to excessive magnetic fields (e.g. in an
MRI room). If necessary, longer infusionlines can be used. Whenusing a
defibrillator, precautions must be observed which can be found in the
documentation for the defibrillator.
a For the safe use of Space infusion pumps in MRI the SpaceStation MRI is
recommended.
a In any case of central alarm (e.g. from staff call) 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 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 startingthe
infusion again.
Recommendation: bolus reduction by opening the outward conducting system.
The 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 complies with:
a IEC/EN 60601-1,
a IEC/EN 60601-1-1,
a IEC/EN 60601-1-2 as well as
a IEC/EN 60601-2-24
and is CE marked in compliance with EU-Directive 93/42.
B. Braun Melsungen AG is certified accordingto DIN EN ISO 9001 and
DIN EN ISO 13485.
This certification also includes maintenance and service.
The visible LED’s comply to class 1 LED products according to IEC/EN 60825-1.
The B. Braun Space System is a flexible docking and communication system for the
medical workplace, in particular the intensive medical care, which substantially
contributes to the safety of its patients.
It serves the perspicuous accommodation of the infusion and infusion-syringe pumps
Infusomat® Space, Infusomat® Space P and Perfusor® Space, whose concrete
application is the medical professional decides on based upon guaranteed
6
PATIENT SAFETY
characteristics and technical data. The pillar and mounting system synchronized
system components enables the individualized workplace design.
The Space System 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 further descriptions as well as assembly resp. disassembly please see this
Instructions for Use.
Transport damages:
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.
7
Chapter1
THE SPA C E S TATION IN DETAIL
THE SPA CESTAT ION IN D ETAIL
SpaceStation serves 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 require their own mains supply and
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.
Connector for further
SpaceStations or
SpaceCover comfort;
F5
Connector for Space
pump. Data lines and
12 V voltagesupply;
F2A to F2D
Guide rails forthe individual pumps
Central loudspeaker,
onlycontainedin
SpaceCover comfort
Lever to release
universal clamp
Fixture of universal
clamp SP, rotatable
for attachmentto
wallrailsand infusion
poles
Mains power input;
F1A
Mains voltage outlet to
the next SpaceStation;
F1B
Connection for extension cable
for further SpaceStation; F4
Connection for staff call, PCA
button, ConnectionLead SP 12V
and service cable; F3
w Attention: Do not connect
the Power Supply SP to this
connector
8
Chapter1
Rotary knob to
unlock single pumps.
Locking happens
automatically when
the pump is pushed
in.
Hoseroutings for
infusiontubing
THE SPA C E S TATION IN DETAIL
Cover SpaceCover; must always cover the
uppermost segment. Serves at the same
timeas carrying handle for a SpaceStation.
Lock/unlock of
upper SpaceStation
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 areconnected to each other
via the connectors F2A to F2D. The plugs are to be protected from damage and
humidity.
1.1 Fastening a Single SpaceStation
Every single SpaceStation can be attached to infusion poles and vertical tubes, e.g.
pendants suspension, as well as to horizontal wall rail systems according to EN 1789
without need of any further adapters or assembly auxiliaries. The rear universal clamp
can be rotated and has a quick-action mechanism. By pulling the release ring back, the
slide can be moved freely and prepositioned. Now the SpaceStation can be definitely
fixed by means of theset screw.
w Attention: Make sure that the SpaceStation is fastened correctly and safely after
9
Chapter1
THE SPA C E S TATION IN DETAIL
By pullingthe releasering back, the slide can be moved
freely for prepositioning.
assembly. Do not use tools to tighten the screw !
To release, first loosen the clamp by turning the adjustingknob half and then pull the
release ring in order to loosen the pole clamp using the quick gripping mechanism.
10
1.2 Assembly and Disassembly of 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 corresponding position and take out the
upper segment to the front.
w Attention: Every single SpaceStation must be fixed to a fastening tube by means
of a fixation clamp.
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 assembly tools.
The admissible combinations are listed in the following table:
Chapter1
THE SPA C E S TATION IN DETAIL
1Pillar 2 Pillars 3 Pillars
A A B A B C
SpaceCover Comfort 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 A ≤ 6 ∑ A + B ≤ 6 ∑ A + B + C ≤ 6
(x) alternative usage possible A,B,C number of SpaceStation in one pillar
w Attention: Other configurations,such as more thanthree pillars or exceeding the
number of SpaceStations within a pillar, are not permittedand result in
configuration error.
If a system consists of several pillars, these should be arranged logically and
physically from left to right.
Pillar 1(A) Pillar 2(B)
Extension lead SP 60 or 120 cm. The lead is connected to F4
in pillar 1 and then to F3 in pillar 2.
w Attention: If the pillars will not be connected as described above,inter-
changing F4 and F3, there is a wrongtopological representation in SpaceOnline and
wrong addressing in the BCC protocol.
11
Chapter1
THE SPA C E S TATION IN DETAIL
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 status and alarm information are
shown at the corresponding cover.
Pillar 1(A) Pillar 2(B)
Extension lead SP 60 or 120 cm. The lead is connected to F4 in pillar
1 and then to F3 in pillar 2. Pillar 2 and 3 are interconnected with each
other via F3 and F4.
Pillar 3(C)
12
Chapter2
COMBINAT I O N OF PUMPS WITHIN A SPA C E S TATION
COMB INATI ON OF PUMPS WITHIN A
SPACE STATIO N
The following pumps and modules can be combined within a SpaceStation.:
• 4 pumps; Infusomat® or Perfusor® Space and optional SpaceCom
• 3 Space pumps and 1 SpaceControl and optional SpaceCom
• 2 Space pumps and 2 SpaceControl and optional SpaceCom
• 4 Space pumps and 1 SpaceControl, attached to thelowest 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
Loading...