Operating Manual Infusomat Space PDF

Infusomat® Space
and Accessories
Instructions for Use
It is recommended that all pumps at

your care unit are equipped with the
same software version.
GB Valid for software 686M
CONTENTS
Infusomat® Space Overview ...................................................................................................3

Symbols on Product...................................................................................................................5
Patient Safety ........................................................................................................................6
Menu Structure / Navigation ...............................................................................................11
Chapter 1 Operation..........................................................................................................14
1.1 Start of Infusion .........................................................................................................................14
1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused)
and Time........................................................................................................................................16
1.3 Bolus Application .......................................................................................................................17
1.4 Infusion Line Change and New Therapy Start...................................................................18
1.5 End of Infusion............................................................................................................................20
1.6 Standby Mode .............................................................................................................................20
Chapter 2 Advanced Operations ....................................................................................21
2.1 Status Request of Pump when Infusion is Running ........................................................21
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data.................................................................................................................21
Chapter 3 Special Functions*..........................................................................................22
3.1 Dosing Units and Dose Rate Calculation (Overview).......................................................22
3.2 Dose Rate Calculation (Operation)........................................................................................22
3.3 Drug Library..................................................................................................................................23
3.4 Patient Controlled Analgesia (PCA) (optional) ..................................................................26
3.5 Target Controlled Infusion (TCI) (optional).........................................................................27
3.6 Barcoding......................................................................................................................................33
3.7 Piggyback Function....................................................................................................................34
3.8 Ramp and Taper Mode..............................................................................................................36
3.9 Program Mode.............................................................................................................................39
3.10 Intermittent Mode.....................................................................................................................40
3.11 Dose Over Time ...........................................................................................................................43
Chapter 4 Autoprogramming..........................................................................................45
Chapter 5 Options ..............................................................................................................49
5.1 Occlusion Pressure .....................................................................................................................49
5.2 Upstream Occlusion Pressure .................................................................................................49
5.3 Data Lock ......................................................................................................................................49
5.4 Bolus Rate.....................................................................................................................................50
5.5 KVO-Mode ....................................................................................................................................51
5.6 Contrast / Display Light / Keypad Light...............................................................................51
5.7 Alarm Volume ..............................................................................................................................51
5.8 Date / Time ...................................................................................................................................51
5.9 Macro Mode.................................................................................................................................51
5.10 Language.......................................................................................................................................52
Chapter 6 Alarms................................................................................................................53
6.1 Device Alarms..............................................................................................................................53
6.2 Pre-Alarms and Operating Alarms ........................................................................................53
6.3 Reminder Alarms ........................................................................................................................56
6.4 Alarm Hints ..................................................................................................................................56
*The availability of Chapter 7 Battery Operation and Maintenance .......................................................57
the listed features Chapter 8 Start Up Graphs and Trumpet Curves ......................................................59
is depending on
Chapter 9 Technical Data.................................................................................................60
the configuration
of the pump. Chapter 10 Warranty / Training / TSC** / Service / Disinfecting / Disposal ......67
**Technical Safety Chapter 11 Instructions for Use Accessory ...................................................................71
Check. Ordering ......................................................................................................................76
2
INFUSOMAT SPACE® OVERVIEW
I N F U S O M AT ® S PA C E O V E R V I E W
Arrow up and -down
Scroll through menus, change setting of numbers from Press to reset single values
0-9, answer Yes/No questions. to zero and switch back to Press to
Arrow left and -right the previous screen/menu open the
Select data from a scale and switch between digits when level. pump door.
numbers are entered. Open a function while pump is
running or stopped with the left arrow key.
c x
q Press to
Yellow LED: Pre-alarm, reminder alarm
initiate Press to turn
Green LED: Infusing bolus. pump on/off.
Red LED: Operating or device alarm
Blue LED: Initiating connection to wireless
battery or Space Station
n o
B
k m
Open certain functions Press to initiate f
S
and press to confirm auto-programming Press to Start/Stop
values/settings/alarms. orders when prompted. infusion.
Cover of Battery Compartment

Before changing the battery, always disconnect the pump from the patient and switch off the device.
To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover
away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange.
A crank in order to open the pump door in case of emergency is attached to the inside of the battery compartment
cover (for closer information see 1.4).
Port for drop sensor
Port P2 for power supply, SpaceStation,

Port P3 for future options
connection lead (12V), combi lead and
further accessory leads (staff call, service)
3
INFUSOMAT® SPACE OVERVIEW
Downstream Air
pressure sensor sensor
Opening lever
Pump based free flow Yellow Line guide Upstream

prevention safety clamp caution light cover pressure sensor
Pole clamp handle Fixaton of PoleClamp (Universal Clamp)

Line up bar of pump with bar of PoleClamp
Pole clamp and slide PoleClamp forward until locking
release button
mechanism clicks.
To remove, press release button on frame,
Pump slots push handle down and pull PoleClamp
backwards.
Transport
A maximum of three pumps (Infusomat®
Space or Perfusor® Space) plus one
SpaceControl may be stacked together (in
ambulance cars and helicopters only one
pump). Avoid external mechanical
influence.
Locking Devices Together
Line up the bar of the lower pump with the
bar of the pump above and slide the lower
pump backwards until the lock clicks and
the green buttons are above each other.
To disconnect, push green locking buttons
of top pump device and slide bottom pump
forward.
Caution: Avoid external mechanical
action.
Pole Fixation
Push the opening of the PoleClamp against
the vertical pole and lock the screw tightly.
Unscrew to release.
For vertical fixation of PoleClamp push
lever down and rotate either way until lever
clicks into notch. Push lever for rotation.
Caution: Do not lean on pump when
attached to pole!
Caution: A maximum of three B. Braun
Space pumps can be stacked together
when used with the PoleClamp SP.
4
SYMBOLS ON PRODUCT
SYMBOLS ON PRODUCT
Symbol Explanation
Mandatory action: see instruction for use.
See accompanying documents.
Type CF unit with defibrillation protection
Protection class II device
Symbol indicating separate collection for electrical and

electronic equipment (2002/96/EC)
CE mark compliant to Directive 93/42/EEC
Temperature Limit
Moisture Limit
Limitation of the atmospheric pressure
Non-ionizing electromagnetic radiation
General warning sign (e.g. Caution)
5
PATIENT SAFETY
PAT I E N T S A F E T Y
w Intended use
The Infusomat® Space Volumetric Infusion Pump System includes an external
transportable electronic volumetric infusion pump, dedicated administration
Read Instructions
sets, and pump accessories. The system is intended for use on adults, pediatrics,
for Use prior to use.
and neonates for the intermittent or continuous delivery of parenteral and
The infusion device
should only be enteral fluids through clinically accepted routes of administration. These routes
used by specially include, but are not limited to intravenous, irrigation/ablation, and enteral. The
trained staff. system is used for the delivery of medications indicated for infusion therapy
including but not limited to colloids and cristalloids, blood and blood
components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The
Infusomat® Space Volumetric Infusion Pump System is intended to be used by
trained healthcare professionals in healthcare facilities, home care, outpatient,
and medical transport environments.
Using TCI the scope of patients is:
Minimum Maximum
Weight [kg] 30 200
Height [cm] 130 220
Age [Yrs] 16 100
Some parameter sets are using the Lean Body Mass (LBM) to individualize the
parameterization. The LBM calculation may furthermore restrict the scope of
patients as it will not allow TCI for obese patients.
Using TCI the scope of procedures is:
• Propofol: Anaesthesia and Conscious Sedation
• Remifentanil: Anaesthesia
Qualified medical staff should decide how the device should be used based on
its features and specifications. For more details, please read the Instructions for
Use.
Operation
• The initial training of the Infusomat® Space is to be performed by B. Braun
sales personnel or other authorized persons. After each software update, the
user is required to inform himself about the changes to the device and
accessories in the instructions for use.
w Caution: Ensure the unit is properly positioned and secured. Do not position
4
pump unit above patient or in a position where a patient could
come to harm, should the pump fall.
• Prior to administration, visibly inspect the pump for damage, missing parts or
contamination and check audible and visible alarms during selftest.
• Not be used adjacent and stacked with other equipment except B. Braun
6 Space devices.
PATIENT SAFETY
• Only connect to patient once the line has been correctly inserted and
completley primed. Interrupt connection during line change to prevent
incorrect dose delivery.
• Select infusion line/catheter suitable for use with the intended medical
application.
w Caution: Position the infusion line free of kinks.
4
• Recommended change of disposable every 96 h (or as per national hygiene
regulations).
• Installation in medically used rooms must comply with the appropriate
regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national
specifications and deviations.
w Caution: Operate the pump at least 25 cm from flammable anaesthetics to
4
prevent explosion.
• Compare the displayed value with the entered value prior to starting
infusion.
• If staff call is used we recommend checking the equipment once after
connecting the pump.
• Protect the device and the power supply against moisture.
• If the pump falls down or is exposed to force, it must be checked by the
service department.
• The displayed data must always be checked by the user prior to making
further medical decisions.
• During mobile use (homecare, patient transport inside and outside the
hospital): Make sure the device is securely fixed and positioned. Positioning
changes and severe shock can lead to minor changes in the delivery
accuracy and/or unintentional bolus administration.
• A supplemental patient monitoring must be carried out if life-saving
medication is performed.
• The air detector cannot detect air diffusing in the following components:
three-way stopcocks, infusion adapters and further lines placed between
pump and patient.
• In case high potent drugs are given be sure to have a second infusion pump
for that drug at hand. The therapy documentation should be suitable to
continue the therapy at the second infusion pump.
• Independant of the soft limits the selected values have to be the medically
correct ones for the given patient.
• In case values relevant for the dose rate calculation are changing always the
flow rate will be updated and the dose rate will be fix.
• Consider startup characteristics before using low infusion rates (0.1ml/h)
with critical drugs.
7
PATIENT SAFETY
Enteral Nutrition
The Infusomat® Space may be used for enteral nutrition. Do not use enteral flu-
ids for intravenous infusion as this may harm your patient. For this reason only
use disposables dedicated and labeled for enteral nutrition.
Transfusion
The Infusomat® Space may be used for blood transfusion, too. For this therapy
only use disposables dedicated and labelled for transfusion.
Other components
• Use only pressure-proof and compatible disposable items (min. 2 bar/
1500 mm Hg) to avoid influencing performance data - which would result in
impairing patient safety.
• Where several infusion lines are connected on one single vascular access, the
possibility of the lines exerting a mutual influence over each other cannot be
excluded.
• Refer to respective manufacturer’s information for possible incompatibilities
of equipment with respect to drugs.
• Use only compatible combinations of equipment, accessories, working parts
and disposables with luer lock connectors.
• Connected electrical equipment must comply with the relevant IEC/EN-
specifications (e.g. IEC/EN 60950 for data-processing equipment). The
user/operator is responsible for the system configuration if additional
equipment is connected. The international standard IEC/EN 60601-1-1 has to
be taken into account.
Safety Standards
Infusomat® Space satisfies all safety standards for medical electrical devices in
compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24.
• The EMC-limits (electro-magnetic compatibility) according to
IEC 60601-1-2:2007 and IEC 60601-2-24: 2012 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 etc.) may be disturbed. Maintain the
protective distances recommended by the manufacturers of these devices.
• The Infusomat® Space fulfils the applicable requirements of EN 13718 to be
used in the air, on the water and in difficult terrain. During transport the
Infusomat® Space needs to be fixed on a suitable restraint system by means
of SpaceStation or Pole Clamp SP. When stored under temperature conditions
beyond the defined operating conditions the Infusomat® Space needs to
remain under room temperature at least one hour before usage.
8
PATIENT SAFETY
• As there is no dedicated norm existing for enteral feeding pumps the safety
features of Infusomat Space are also for enteral nutrition according to the
a.m. norms.
Safety instructions for using PCA

• In case the demand button is used with SpaceStation the PCA pump has to
be placed in the lowest slot of the lowest SpaceStation.
• Access to the pump settings can be prohibited by DataLock 3. The code for
DataLock level 3 should differ from the one for levels 1 and 2 in case the
pump is only allowed to be used by pain management professionals.
• When ending PCA and starting it again the therapy data are set to default
values.
• Using the demand button also the patient is a permitted user. With the
demand button only a PCA-bolus can be requested. This is limited to pre-
defined doses by drug list and pump settings.
Safety instructions for using TCI

• TCI should only be performed by experienced anaesthetists being familiar
with the principles of TCI and properly trained in using the present device.
• The use of TCI with B. Braun Space does not limit the responsibility of the
anaesthetist for administration of drugs. They need to be fully aware of the
available literature for any parameter set used in association with a drug and
need to refer to the prescribed information for rate and dosing limits.
• Pharmacokinetic and pharmacodynamic interactions among anaesthetic
drugs are known, but are not taken into account into the calculation of the
plasma and effect site concentrations. They have to be taken into account by
the user.
• In particular, the user must be aware that starting the TCI will result in the
automatic infusion of a pre-calculated bolus dose followed by an infusion to
achieve the selected target concentration.
• It is essential that the user verifies that the patient characteristics and the
selected target concentration as well as the resulting dosages conform to the
prescribing information of the relevant country.
• B. Braun has verified the accuracy of the mathematical model
implementation, the usability as well as pump delivery accuracy.
• While using TCI an appropriate patient monitoring is mandatory.
• Take care of using the right dilution/concentration of the drug and make sure
the right dilution is selected at the pump.
• Never administer Propofol or Remifentanil by a second infusion as long as
you use TCI.
9
PATIENT SAFETY
• It is possible to completely switch off the TCI mode to avoid the use of TCI
accidentally.
• By using Infusomat® Space a change of drug concentration will not be
possible within the same therapy.
Safety Instructions for using Pole Clamp
1. Line pump up with the Pole Clamp

guide rails.
2. Slide pump fully into place onto the
guide rails.
3. An audible “Click” should heard.
4. Test the pump is secure.
W
The pump ist now securely attached to
Pole Clamp.
• Do not lean on the pump when
attached to the Pole Clamp.
• Do not position the pump unit
above the patient.
Underside view
Clamp grids W
• DO NOT use any Pole Clamp that
shows signs of damage.
• DO NOT use Pole Clamp with
missing clamp grids.
10
MENU STRUCTURE / NAVIGATION

Cutline
o On/Off button C Clear button
x Door open button K OK button
f
s Start/Stop button Q Keypad with arrow up, -down,
b
n Bolus button -left, -right button
m Connection button
All display screen shots are examples and may be different when related to an
individual patient and individualized therapy.
Display Meaning
At the top of the screen the last therapy is

indicated. Yes/No question can be
answered by pressing u for yes or d
for no.
Parameters which can be changed (e.g.

rate in ml/h) are opened with l or
k. When editing parameters, switch
digits/levels using l r. White
background indicates current digit/
level. Use u or d to change current
setting. Help text on the bottom/top of
the screen indicates options how to
proceed (e.g. confirm rate with k,
start infusion with f
s or clear rate by
pressing c).
Typical display during infusion:
Mains Set pressure limit and

connection current pressure
Battery Therapy profile
status
Active VTBI- or time preselection
Scrolling arrows indicate pump is infusing
Set rate can be opened with l
Unit of drug application

Total volume infused. Alternatively the intermediate volume can be displayed.
Remaining time
Remaining VTBI
11
Display Meaning
All status information is available in the

bottom line of the display. The desired
information can be selected by using d
u and will be displayed permanently
thereafter (e. g. drug long name, current
system pressure etc.).
b
n has been pressed while the pump is
infusing. Start manual bolus at
1200 ml/h by pressing k (see top of
display) or proceed to set bolus limit
with l (see bottom of display).
This hint pops up if a user tries to edit or

change a parameter by pressing l when
that parameter is unable to be changed.
Set pressure level with l or r and con-

firm by pressing k.
Cancel to edit pressure by using c.
Pre-alarms are indicated by a message on

the display (e.g. “VTBI near end”), an
audible tone and the yellow LED is
constantly on. To confirm a pre-alarm
press k.
In case of an operating alarm (e.g. "VTBI

infused") the infusion stops, an audible
tone sounds and the red LED flashes.
Confirm alarm by using k.
Confirming does not activate an acoustic
feedback.
Press and hold o for 3 sec to turn pump

off. A white bar stretches from left to right
and counts down the 3 sec.
As long there is an infusion line inserted
the pump will not turn off but will use
standby.
12
Start Up Main Special Options Status

Menu Menu Functions Menu Menu
Line Dose Rate Occlusion Intermediate

Dose
selection Calculation Pressure volume
Intermediate
Prime ? Concentration Drug Library Data Lock
amount
Use last Change-over Bolus Intermediate

Weight
therapy ? from Rate time
continuous
mode to PCA
Use drug KVO- Total
Rate
library ? Mode volume
Use dose rate Total

VTBI Contrast
calculation ? amount
Display Total
Time
Light time
Special Keypad
Line
Functions Light
Alarm Battery
Options
Volume capacity
Status Date WLan
Time Version
Macro Drug
Mode info
In Dose Mode:
Display of flow
rate in large
scale
Language
13
OPERATION
Chapter 1
OPERATION
1.1 Start of Infusion
• Ensure that the pump is properly installed. Check the equipment for completeness
and damages. Do not attach the infusion bottle below the pump level.
• Put the spike vertically into the infusion bottle. Fill the bottom part of the drop
chamber by max. 2/3.
w Caution: Close the roller clamp before inserting the IV line and do not
4
connect to
patient until properly loaded and primed.
• If the device is connected to the mains, the display indicates the battery status, the
mains connection symbol and the last therapy.
• Press o to switch on the device. Observe the automatic self-test: The message
“Self-test active” and the software version are displayed, two audible tones sound
and all three LEDs (yellow, green/red and blue) flash once. Information about the
power supply (mains or battery operation) and the set pressure level are indicated.
In addition, the line type appears at first (provided that the line is already inserted).
Then, the accumulated air volume and the max. size of air bubbles is indicated
which is triggering the air alarm of the device.
The pump offers the possibility to load up to four languages into the pump
(depending on the number of the language specific characters), among which the
user can choose during the operation of the pump. During the first ever start-up of
the device, the user is requested to select the languages and to mark them with l.
After that, the selection has to be confirmed by choosing the last menu item at the
bottom of the list and pressing k. Then the desired language must be selected with
t and confirmed with k. Answer the following question with d in order to
activate the selected language.
• Press c to start the direct entry of therapy parameters, or press x and u to
open the pump door in order to continue with inserting the line.
w Caution: Close the roller clamp before inserting the IV line and do not
4
connect to patient until properly loaded and primed.
Caution: You may only insert the line while the device is switched on and the line
guide element is inserted. Otherwise, there is the danger of freeflow. Pay attention to
keep the roller clamp closed before inserting the infusion line especially at a tempera-
ture scale of 10 - 15 °C. Never leave the pump unattended when inserting the tube.
Caution: Inserting different lines into the pump is identical. Please see instructions and
packaging of the different lines (standard, transfusion, opaque, enterel nutrition etc.)
to receive information about preparation and usage of these lines.
• Firmly press tubing into the air sensor guide to make sure the line is properly
14
OPERATION
Chapter 1
Insert the infusion line from right to

the left. Make sure that the line is
routed straight. At first, route the line
through the upstream sensor. Then,
insert the two-hole clip.
Next attach the white clip.

Insure silicone segment is not
stretched or twisted, stars on tubing
must be in straight line and should
not be twisted.
Insert the freeflow clamp (see red

arrow) in the opened aperture, in the
direction indicated by the arrow, until
the opening lever locks in and the
safety clamp squeezes the lines
(flashing signal lamp goes out).
inserted into the sensors. Thread the tubing through the notches on the right and
left side of the pump.
• Close the pump door by firmly placing pressure with both hands on each side of the
pump door, continue to press firmly until you hear and feel the motorized door
latch pull the door shut. Do not open roller clamp until the pump directs you to do
so when self test is completed. Then select the inserted line with t and confirm it
with l. Open the roller clamp.
Caution: Do not force door closed – If door is difficult to close, please check IV set and
anti free-flow slide clamp (green) for proper installation.
Caution: Before opening door, please close roller clamp and ensure door does not fall
open. If door opens to the horizontal position, please check that the slide clamp (green)
is properly occluding the IV set and the door extension hook is not broken. If the door
hook is found damaged or broken remove the pump from service.
Caution: If a wrong line is selected the time until the pump goes into a pressure alarm
15
OPERATION
Chapter 1
may be prolonged. Also a wrong delivery rate is possible.

• Press u if the prime function is enabled to prime the infusion line with the rate
displayed. Cancel priming with k. Repeat the procedure until the line is
completely primed. Then press d to proceed.
Note: During priming, all air and drop alarms are switched off.
• Establish the patient connection.
• Answer the question whether the old therapy is to be used either with u or d
(the question can be deactivated via the service manual). If you select u, the
pump jumps to the Main Menu.
Note: At rates smaller 1 ml/h the detection of a closed roller clamp cannot always be
ensured due to physical reasons. A drop sensor may be used to avoid this risk.
Adjusting the delivey rate:
• In the Main Menu, open the rate with l and set it with q.
• Press f
s to start the infusion. VTBI is required to start the infusion. Time will
be calculated when rate is entered. When time is entered, rate/doserate will
be calculated. Running arrows on the display and the green LED indicate that
the pump is infusing.
Note: If Infusomat Space Line SafeSet is used, VTBI is not required.
Note: The running infusion can be cancelled at any time by pressing f
s. The
pump can be turned off at any time by pressing o for 3 sec (Exception: Data
lock level 2) and as long a disposable is inserted.
1.2 Entry With Different Combinations of Rate, VTBI

(= Volume To Be Infused) and Time
The Infusomat® Space offers the possibility to enter a volume- and time limit in
addition to an infusion rate. When two of these parameters are entered, the third is
calculated by the pump. If a volume and/or time is preselected, an arrow symbol is
placed in front of one of these parameters in the Main Menu. It is called the “target”.
During the infusion of the pump, this target symbol is displayed next to the moving
arrows in the run display (this symbol is not visible in case TCI is used). This indicates
that the pump has been programmed, either with a volume- or time limit. The
assignment of the target symbol, apparent in the Main Menu, shows the established
parameter for the application (VTBI or time). When the rate is changed, the so-called
target parameter is principally not adjusted to the new rate but to the parameter
which does not have the target symbol in front. After the infusion has started, the
remaining VTBI and time are displayed in the status menu and the run display
(values are counting down).
16
OPERATION
Chapter 1
1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the
bottom of the display.
Target: Volume
• Select VTBI with t and open with l.
• Enter VTBI with q and confirm with k.
• Select time with t and open with l.
• Enter time with q and confirm with k.
Check calculated rate on plausibility.
Proceed in the same way to calculate 2.) and 3.).
2.) Infusion with volume limit
Enter rate and VTBI: The infusion time will be calculated and displayed on the
Target: VTBI
3.) Infusion with time limit
Enter rate and time: The infusion volume will be calculated and displayed on the
Target: Time
Changing already entered values of VTBI and time (rate, VTBI and time already exist
at the point of change):
a) Target symbol is placed in front of VTBI:
• Change of VTBI => Adjustment of time. Old and new target: VTBI
• Change of time => Adjustment of rate. Old and new target: VTBI
b) Target symbol is placed in front of time:
• Change of time => Adjustment of VTBI. Old and new target: Time
• Change of VTBI => Adjustment of time. New target: VTBI
1.3 Bolus Application

After pressing the button b
n, the bolus unit can be selected by using d.
Note: The selected unit will not be stored. It is possible to administer a bolus
in ml.
There are three ways to administer a bolus:
1.) Manual Bolus: Press b n. Then press k and hold button. Fluid is
administered for as long as the button is held down.. The infused bolus
volume is displayed.
The max. bolus time is limited to 10 sec.
Reaching this limit is indicated by an acoustic signal.
2.) Bolus with volume preselection: Press b
n. Then press l and set bolus dose
limit by using q. Press b
n to confirm and start bolus. Depending on the
17
OPERATION
Chapter 1
service tool settings an acoustic signal will sound after finishing the bolus
volume.
3.) Bolus with rate calculation: Press b
n. Then press l and set bolus dose by
using q. Press k to confirm bolus dose. Set time with q in which a
bolus is to be delivered. Calculated bolus rate is shown on top of the display.
Press b
n to confirm and start bolus.
You can use the service program to enter a default and a maximum bolus rate.
Once a new therapy is started the device always returns to the default rate
- even if the bolus rate was manually changed beforehand.
Note: If the bolus limit is not entered after pressing b
n, the pump switches
back into the run display automatically.
Note: The infused volume during bolus with volume preselection counts up.
In order to purge the line at any time while the pump is stopped press b
n.
Answer the following question by pressing u in order to start the purge
process. Cancel by pressing k or any other key.
Caution: Take care not to overdose! Given a bolus rate of 1200 ml/h, 1 ml will
be administered in just 3 sec. To cancel bolus infusion at any time press k.
At low bolus volumes, under dosages due to the start up characteristic of the
pump and the tolerances in the infusion system cannot be excluded. Disconnect
patient while purging.
1.4 Infusion Line Change and New Therapy Start

Note: Always interrupt the patient connection before changing a line to avoid dosing
errors. Never let the pump run unattended when changing the line. Check and clean
the safety clamp regularly.
• Press f
s to stop the delivery. The green LED goes out. Close the roller clamp
and interrupt the patient connection.
• Press x and open the pump door with u. Press down the green opening lever
completely until it locks in place, remove the line and insert a new line.
Note: In the unlikely event the pump door cannot be opened remove the allen key from
the inside of the battery compartment cover. Use this key to remove the
emergency aperture cover of the pump. Place the crank in the aperture and turn it
clockwise until the pump door opens.
18
ADVANCED OPERATIONS
Chapter 2
Push cover opening with pen.
Remove crank from inside of

battery cover.
Turn crank to remove emergency

aperture cover.
Remove emergency aperture cover.
Turn crank inside aperture to open

the door.
19
OPERATION
Chapter 1
• Close the pump door, confirm the inserted line with k and open the roller clamp.
• If required, prime the pump with u. Then press d to proceed when priming is
complete.
• Establish the patient connection and check the parameters with t.
• Start the infusion by pressing f
s.
Note: A new therapy can be started at any time during a stopped infusion. If the pump
is in the Main, Status or Options Menu, press C (repeatedly) and follow the
instructions as described.
1.5 End of Infusion

• Press f
s to stop the infusion. The green LED goes out. Close the roller clamp
and interrupt the patient connection.
• Press x. Answer the question whether the pump door is to be opened with
u.
• Press down the green opening lever completely until it locks in place.
Remove the line and close the pump door.
• Press o for 3 sec to switch off the pump.
Note: The settings will be permanently saved by the switched off device.
Note: Pump cannot be powered off with IV line inserted.
1.6 Standby Mode

In the case of extended interruption, the user has the option to maintain the set values.
• Press f
s to stop the infusion. Then press o for less than 3 sec.
• Confirm that the pump is supposed to switch to standby by pressing u.
• The pump is now in Standby.
While the pump is in the standby mode, it’s display shows the drug and the remaining
time for this mode, standby may be set from 1 min to 24 hours. Change of remaining
time by pressing l. Exit standby by pressing c . The pump will alarm when the
standby time expires.
As long as a disposable is inserted in the pump will use standby also in case o is
pressed for at least or more than 3 sec.
20
ADVANCED OPERATIONS
Chapter 2
ADVANCED OPERATIONS
2.1 Status Request of Pump when Infusion is Running
Press c to switch between run display and Main Menu while the device is
infusing. Navigate through the menu using t to check parameters. In order to
check the menu parameters in the Status-/Options Menu, select "Status"
respectively "Options" in the Main Menu, open menu with l and scroll
through menu with t.
2.2 Rate, VTBI and Time Change Without Infusion

Interruption and Reset Of Status Menu Data
• Press c when the pump is in the run display in order to switch to the Main Menu.
Select rate/VTBI/time with t and press l in order to open the parameter.
• Enter new value with q and confirm with k.
Reset Status Menu Data:

The parameters intermediate volume and -time can be reset when the pump is
infusing or when the pump has stopped.
• Select “Status” in Main Menu with t and press l.
• Highlight intermediate volume (in ml) or intermediate time (in h:min) with t and
open parameter with l.
• Reset values by pressing u.
Both parameter total volume and -time, are displayed in the pump as "Total" with the
according unit and can be reset by starting a new therapy. A second way to reset the
parameters when the pump is in the Main Menu: Press c, answer the question
whether the last therapy is to be used with u and reset the values with u.
The type of the inserted line is displayed in menu item „Line“ and cannot be changed
once it has been confirmed at the beginning of the infusion. The drug info states the
drug name, the name of the drug list and its date of origin. If the change from the
secondary to the primary infusion will be performed manually or automatically will be
displayed in line “PGY change”. The current battery capacity in hours and minutes is
displayed in the menu item “Battery Cap.” and the current software version in menu
item "Version". In-line pressure can also be read in the Status menu in mmHg or Bar
depending on the service settings.
21
SPECIAL FUNCTIONS
Chapter 3
SPECIAL FUNCTIONS
3.1 Dosing Units and Dose Rate Calculation (Overview)
The following list shows the units used in the pump:
Gram family: ng, mcg, mg, g
Unit family: mIU, IU, kIU, MIU
Equivalents family: mEq
Mole family: mmol
Kilocalorie family: kcal
Millitliter family: ml, ml/kg
In addition to these dosing units the user can choose:
• Feeding: kcal, mEq, mmol
• Surface related amount units: m2
Dose
Infusion rate [ml/h] =
Concentration
x [ Patient weight (optional) ]
The pump is calculating the body surface area with the “Dubois” formula
(DuBois D, DuBois EF. A formula. Arch Intern Med 1916; 17: 863):
BSA(m2) = 0.007184 x weight(kg)0.425 x height(cm)0.725.
Check plausibility of calculated body surface area value and resulting delivery
rate before starting the infusion, also, if body surface area related dose rate is
set by Barcode. The dose rate calculation enables a calculation of the rate in
ml/h based on the entered dose parameters.
Setting parameters:
1. Concentration as the amount of the active ingredient per volume.
- Amount of the active ingredient
- Volume in ml
2. Where necessary: Patient weight or Patient height
Note:
- Patient weight can be entered in kg, lbs or grams.
- Patient hight is entered in m (is used to calculate BSA)
3. Dose prescription:
- time related as the amount of the active ingredient per min, h or 24h.
- time and patient weight related as the amount of the active
ingredient per kg per min, h or 24h or BSA.
4. Where necessary: VTBI in ml.
3.2 Dose Rate Calculation (Operation)

a Select dose rate calculation with l.
a Select the unit of the active ingredient with T and confirm it with l.
22
SPECIAL FUNCTIONS
Chapter 3
a Enter the concentration by entering the amount of the active ingredient

and the volume. In order to do so set the values with q and confirm
with k.
a If the patient's weight does not need to be entered press l.
Press t to choose “weight” or “surface” and confirm with k.
a Set the patient weight with q and confirm with k.
a Select the dose prescription with t and confirm it with l.
a Set the dose with q and confirm with k. The rate will be
automatically calculated and displayed at the bottom of the display.
a Check the calculated rate and if necessary the adapted parameters with
t on plausibility before starting the infusion with f
s.
a Check the parameters with t on plausibility before starting with f
s.
Dose can belatedly be changed in the Main Menu in the same way as the rate,
VTBI and time (compare 2.2). The effect of dose
modifications on other parameters is shown at the bottom of the display.
Additionally the total and intermediate amount of the infused drug can be
taken from the Status Menu. These can be checked and reset in the same way
as the other total and intermediate values.
A deactivation of the dose rate calculation is only possible when the pump is
stopped. Press c from Main Menu and then press d.
Caution: A change of the patient weight or height will alter the flow rate.
3.3 Drug Library

Up to 1200 drug names including therapy data, information and up to 10
concentrations per drug can be stored in 30 categories. These drugs can be
subdivided in 50 care units and 16 Patient Profiles. The loading process into the
pump can be performed via a separate PC program (Space Upload Manager &
HiBaSeD).
Note: The drug library can be started over the Start Up and Special Functions
Menu. The user has to make sure prior to the therapy start that the drug library
in the pump complies with the patient target group. The name of the care unit
and creation date (see headline) should be checked in the pump.
There are different ways assigning a drug to an infusion. This can be done while
the infusion is running or when the pump is stopped.
On the one hand, a drug name including the according therapy data can be
taken from the drug library. On the other hand, if a rate, VTBI and/or time were
already defined in the Main Menu, the drug name and the adjusted values of
the data set will be loaded. If a dose rate calculation has already been started a
belated assignment of the drug name nevertheless is possible.
23
SPECIAL FUNCTIONS
Chapter 3
Loading a drug (including the according parameters) from the Main Menu:
• Go to Special Functions Menu and press l.
• Open the drug library by pressing l.
• Navigate through the list with t and select the care unit with l. If you
have already set the care unit once on your pump this step will be skipped for
the next time.
• Change the care unit by navigating through the list until "Change Care
Area" will be displayed. Press k to change the care unit.
• Navigate through the list with t and select the patient profile with l.
If no profile is set, this step will be skipped.
• Navigate through the list with t and select in alphabetical order (all drugs)
or within a category with l.
• If different therapies are related to a drug, choose therapy type with t and
confirm with l.
• Confirm the displayed drug information with l.
• Decide if the safety limits for the drug are to be applied u or if only the
drug name should be used d.
• Check if the drug short name in the Run Menu is the same as the selected
drug. Check the parameter in the Main Menu with t and start infusion with
f
s.
Note: If a drug name has been assigned without safety limits, the following hint
is provided in the RUN screen:
Note: Care unit and Patient Profile can not be changed within a therapy (incl.
Piggyback mode).
Initial Bolus:
Initial Bolus has to be configured in the Drug List Manager.
• Use the drug library according to the instructions for use.
• Select the desired drug with t and press l.
Before the initial bolus begins, the bolus menu is displayed to allow editing
the bolus with q.
• Check the parameter and start infusion with f
s.
24
SPECIAL FUNCTIONS
Chapter 3
Hard Limits:
If the set rate/dose/bolus volume and bolus rate exceed the values stored in the
drug library (hard limits), the drug will be rejected, a hint will be displayed and
the pump will fall back into the drug selection. If this occurs while the pump is
infusing the pump will continue to administrate.
Soft Limits:
For the same parameters so called soft limits can be preset via the Drug List
Editor. These can be exceeded without any constraint. The following symbols
that describe the status with regard to the soft limits are being displayed:
The infusion is within the range of the minimum and maximum
soft limits =
The infusion is within the range of the maximum soft limit =
The infusion is within the range of the minimum soft limit =
Violation of the upper soft limit =
Violation of the lower soft limit =
No soft limit is defined =
Only a drug name is available =
(It is possible to select a drug name only from the drug library)
The limits of the drug library have to comply with the limits of the pump and
the disposable.
Note: An adequate monitoring when infusing highly potent drugs is
recommended.
Note: In case a drug from the drug library is selected and the pump is running
under dose rate calculation the initial values will be overwritten by the drug
library values if selected.
Remote Drug Library update from Upload Manager (Space Online Suite)
The file icon blinks every 2 s. An update is available.
The Drug Library Upload starts as soon as the pump is in Passive mode.
Note: You can cancel the upload by pressing c.
Please contact your local sales represantative in case you like to use Remote
Drug Library update.
25
SPECIAL FUNCTIONS
Chapter 3
3.4 Patient Controlled Analgesia (PCA)
For PCA a drug list with at least one drug activating the profile PCA is
necessary. By this the conditions for an effective and safe therapy are defined.
Switch on pump with o and wait until self-check is finished. Depending on the
settings the choice of a drug is offered direcly or the pump is in “Main Menu”.
Select “Special Functions” with t from “Main Menu” and confirm with l.
Select drug list, category and desired drug by using q.
After the selection the pump offers
additional drug related
Information which are confirmed
by l.
Select profile PCA by using and

confirm with t .The therapy
settings stored in the drug list are
displayed *.
The therapy can be started now with f
s in case all values are defined.
Depending on the pre-defined settings the therapy is started with an initial
bolus and a basal rate or not.
Before leaving the patient the pump should be put into DataLock level 3 with
q in Menu “Options”. This is necessary especially in case non-authorised access
to the settings can be anticipated.
The code is entered with q and confirmed with k.
The pump display now may look
like this.
In this state the patient is allowed to demand boli. Depending on the status of
the therapy these are either administered or denied. Changing the disposable is
also possible by using the code for level 1 or level 2. Altering the settings for
PCA or other therapies however is only possible with the code for level 3.
The status of the therapy can be checked in the menu „Status“ .
Enter the „Main Menu“ with c and select the “Status“ with q.
The A/D-ratio indicates the
percentage of administered and
demanded boli thus giving an idea
about the effectivity of the therapy.
*Bolus volume is the volume of a single bolus the patient may demand. Max. Limit is the amount of
drug or volume a patient may demand within a certain time in total. Lockout is the time in between
26 two boli.
SPECIAL FUNCTIONS
Chapter 3
An acoustic confirmation of demanded boli can be activated and modulated by

t in Data Lock 3.
Is a demand button connected, the therapy symbol looks like this:
In case there is no demand button connected the therapy symbol looks like
this: .
The demand button is connected to the interface P2 at the rear side of the
pump.
Hint: It is possible to start a therapy in continuous mode and switch over to
PCA later on (in case the drug is dedicated for use with continuous and PCA
application).
SpacePCA-Chart
If r is pressed on the RUN screen, the SpacePCA-Chart is displayed:
The bar represents a time axis, with the points above the axis representing the
number of boli administered and the points below the axis representing the
number of boli refused.
The chart has a 15 minute resolution and shows max of 5 points per 15 min-
utes. Should more then 5 boli be given or refused in this time, the last point will
be turn bold.
Changes to the PCA parameters are displayed as arrowheads at the bottom of
the chart.
3.5 Target Controlled Infusion (TCI)

Introduction
In TCI the user is defining a desired concentration of drug in the human body
(target) rather than an infusion rate. The rates necessary to reach and maintain
that said concentration are calculated by the pump using an algorithm based on
a three-compartment pharmacokinetic model.
A pharmacokinetic model (PK model) is a mathematic model to predict the
concentration of a drug in the human body (e.g. plasma level) after a bolus or a
continuous infusion of different duration. A PK model is developed by
measurement of plasma level values of a population of patients or volunteers
and the respective statistical analysis. A PK model mostly is a 2- or 3-
compartment model indicating the volumes of the compartments, indicating
rates for the exchange amongst the compartments and indicating rates for
elimination / metabolism of the drug.
27
SPECIAL FUNCTIONS
Chapter 3
A PK model can be parameterized to use it for different drugs as long as it is

suitable for that said drug. The pharmacokinetic model and its parameters are
schematically depicted by the following illustration:
B. Braun Space is offering two modes for TCI:

• TCI by targeting the plasma concentration
In this mode the user selects the desired concentration of a drug in the blood
plasma and the PK model is used to calculate the infusion rates required to
achieve that concentration as quick as possible (unless there is no restriction
defined by the user).
• TCI by targeting the effect-site concentration
In this mode the user selects the desired concentration of a drug at the site
of action and the PK model is used to calculate the infusion rates required to
achieve that concentration as quick as possible (unless there is no restriction
defined by the user). A certain overshoot of the concentration in the plasma
is resulting from this mode.
For effect-site targeting there is a link between pharmacokinetics and
pharmacodynamics necessary. As the effect-site compartment is considered to
have no volume and the rate constant k1e can be ignored the rate constant ke0
is the parameter necessary to perform effect-site TCI. A pharmacokinetic model
modified in such way is schematically depicted by the illustration on the next
page.
28
SPECIAL FUNCTIONS
Chapter 3
TCI with B. Braun Space is possible with two drugs: Propofol and Remifentanil.
For Propofol the user can choose between two parameter sets. The parameter
sets used for these drugs are (Not all parameter sets allow effect-site targeting):
Drug / Parameter Propofol Remifentanil

V1 [Litre] 0,228 * Weight 4,27 5,1 - 0,0201 * (Age - 40) +
0,072 * (LBM - 55)
k10 [min-1] 0,119 0,443 + 0,0107 * (Weight - [2,6 - 0,0162 * (Age - 40) +
77) - 0,0159 * (LBM - 59) + 0,0191 * (LBM - 55)] / [5.1 -
0,0062 * (Height - 177) 0.0201 * (Age - 40) + 0.072 *
(LBM - 55)]
k12 [min-1] 0,112 0,302 - 0,0056 * (Age - 53) [2,05 - 0,0301 * (Age - 40)] /
[5.1 - 0.0201 * (Age - 40) +
0.072 * (LBM - 55)]
k13 [min-1] 0,0419 0,196 [0,076 - 0,00113 * (Age - 40)] /
[5.1 - 0.0201 * (Age - 40) +
0.072 * (LBM - 55)]
k21 [min-1] 0,055 [1,29 - 0,024 * (Age - 53)] / [2,05 - 0,0301 * (Age - 40)] /
[18,9 - 0,391 * (Age - 53) [9,82 - 0,0811 * (Age - 40) +
0,108 * (LBM - 55)]
k31 [min-1] 0,0033 0,0035 0.01402 - 0,0002085 *
(Age -40)
ke0 [min-1] 0,26 0,456 0,595 - 0,007 * (Age - 40)
Reference Marsh et al., Br. J. Schnider et al., Anesthesio- Minto et al., Anesthesiology,
Anaesthesia, Vol. logy, Vol. 88, 1998, 1170- Vol. 86, 1997, 10-33
67, 1991, 41-48 1182 Schnider et al.,
Anesthesiology, Vol. 90,
1999, 1502-1516
Effect-site No Yes Yes
targeting
29
SPECIAL FUNCTIONS
Chapter 3
Drug List
The pre-installed drug list offers the following values:
Propofol Remifentanil
Available Concentrations 5 mg/ml 20 µg/ml
10 mg/ml 50 µg/ml
20 mg/ml
Short name TCIProp TCIRemi
Default Max. Rate 1.200 ml/h 1.200 ml/h
Hard Limit Rate Max of pump Max of pump
Plasma Limit Default 400 % 400 %
Plasma Limit Hard Low 100 % 100 %
Plasma Limit Soft Max 450 % 450 %
Default Target 0.0 µg/ml 0.0 ng/ml
Target Soft Max 8.0 µg/ml 8.0 ng/ml
Target Hard Max 15.0 µg/ml 20.0 ng/ml
Decrement Concentration 1.0 µg/ml 1.0 ng/ml
Default
Default Parameter Set Marsh Minto
Important note: Before installing an additional drug list please contact your local
B. Braun representative!
Setting up the pump

For TCI a drug list with at least one drug activating the profile TCI is necessary. The
drug list in this version is pre-defined. By this the conditions for an effective and safe
therapy are defined.
Switch on pump with o and wait until self-check is finished. Insert disposable and
use the drug lib according to Instructions for Use.
Selecting a drug
Select drug list, category (the TCI drugs need to be selected from the category “TCI”)
and desired drug by using q .
In this example: Propofol.
30
SPECIAL FUNCTIONS
Chapter 3
As a next step select the correct

dilution (concentration) of the drug
to be administered as well as the
parameter set (model) and the Mode
(Effect-Site Targeting or Plasma
Targeting)
These steps are only necessary in case there are different options for that drug.
Input of patient data

Depending on the parameter set one or more of the following data are necessary:
• Weight
• Height
• Gender
• Age
Use q for editing the patient data.

Example.
The editing window appears with the initial setting “0” to make sure editing a value ta-
kes place (exemption: initial setting for gender is “male”).
Using effect-site targeting the weight may be limited due to the constraints of the
LBM calculation.
Important notes:
• Be sure to enter the data corresponding to the respective patient.
• Once the TCI is started patient data can not be altered!
Editing a target and starting TCI

The editor window for setting the target comes up with the default value from the
drug list.
Editing this parameter is guided by
the dose error reduction system
“DoseGuard™” according to the limits
defined in the drug list.
31
SPECIAL FUNCTIONS
Chapter 3
Confirm target with k. TCI can be started now with f

s.
After TCI is started the screen looks the following:

Mode-Indicator
Drug short name
Current plasma an effect-site concentration Target and unit
In the top line there is an icon indicating the parameter set and the mode (Mode Indi-
cator) with following meaning:
• “TCI Ma P”: TCI Marsh plasma targeting
• “TCI Sc P”: TCI Schnider plasma targeting
• “TCI Sc E”: TCI Schnider effect-site targeting
• “TCI Mi P”: TCI Minto plasma targeting
• “TCI Mi E”: TCI Minto effect-site targeting
In the bottom line the status parameters like flow rate, Cp/Ce, infused volume etc. can
be displayed. The desired parameter can be selected by using t . It is recommended to
select Cp/Ce.
In case it is necessary to change the target press l to edit the value.
Useful information while pump is running
By pressing r additional
information can be requested.
Pressing r a second time is offering

a graphical overview.
The line describes the course of Cp over the time and the area describes the course of
Ce over the time. The time window is 20 min (15 min past, 5 min future).
Additional information is left with C.
32
SPECIAL FUNCTIONS
Chapter 3
Finishing TCI
There are two possibilities to finish the TCI Therapy (reversion of anaesthesia or
sedation):
• Set Target= 0
• Stop pump
It is recommended to simply stop the pump by pressing f

s.
Pressing R the pump offers additional information – in this case the
information is modified the following way:
Pressing r again shows up the
graph.
After the therapy is ended there are two possibilities:

a) The pump may be used for TCI with the same drug again but with a new patient.
In this case, cancel old therapy and use new disposables.
b) The pump may go with the patient but in continuous mode (without TCI).
In both cases the “old” TCI needs to

be ended by c and selecting “Yes”
in this screen by pressing u.
In case a) press u in the menu - in

case b) press d.
3.6 Barcoding
The barcoding functionality is included but initially not activated. Please contact your
local sales representative in case you like to use barcoding.
33
SPECIAL FUNCTIONS
Chapter 3
3.7 Piggyback Function
The piggyback-mode offers the possibility to interrupt the current (primary)

infusion temporarily in order to administer a piggyback (secondary) infusion.
Above the pump the piggyback-infusion line is connected with a Y-connector to
the administration set. The secondary infusion is supposed to be located approx.
20 cm higher than the primary infusion. All infusion lines need to be completely
primed. A back check valve has to be placed according to the drawing (see next
page).
A precondition to start the piggyback function is that the pump is stopped.
Note: Please mind to set a VTBI of the primary and secondary infusion that
corresponds to the size of the container. The piggyback infusion can be delivered
in continuous mode or dose over time mode only.
• Enter the rate manually or load into the pump via the dose rate calculation or the
drug library. It is not possible to begin with the secondary infusion if the data for
the primary infusion (rate and VTBI) is not set. To enhance comfort list of drugs can
be adjusted to secondary mode by DrugLib.
• Select „Piggyback” from the Special Functions Menu and confirm with l.
• The change from the secondary to the primary infusion ("PIGY" to "PRIM") can be
done manually or automatically. Correspondingly, if an automatic change is to be
made automatically or manually is to be answered with u or d.
• The rate and VTBI of the secondary infusion can be loaded via the dose rate
calculation, the drug library or are to be entered manually with q.
• Start secondary infusion by pressing f
s. Device delivers the piggyback
volume with the set piggyback rate.
Symbols in the headline of the run display ("PRIM" or "PIGY") will indicate if the
primary or secondary infusion is currently running.
When the piggyback volume is infused the pump automatically changes to the
primary infusion if this was selected. If the VTBI of primary infusion is infused
the pump will continue with the KVO-rate respectively after the KVO-operation
the pump stops and activates an alarm. If a manual change from secondary
infusion to primary infusion was selected, the pump will stop or continue with
KVO after the secondary infusion is completed and the user manually has to
change via the menu item “Change to PRIM“ in the Main Menu to the primary
infusion and start with fs.
Note: Infusion bag must contain residual volume for KVO after infused VTBI.
Note: Switching manually between primary and secondary infusion in the Main
Menu is possible at any time while the pump is stopped. It is recommended to
keep the roller clamp of the non-active infusion closed.
The piggyback therapy can be repeated many times by changing the piggyback
medicament or by reset of the piggyback medicament.
34
SPECIAL FUNCTIONS
Chapter 3
• Go to „Set new Piggyback” in the Special Functions Menu and confirm with l.
Note: Resetting the data of the last secondary will also reset VTBI
35
SPECIAL FUNCTIONS
Chapter 3
3.8 Ramp and Taper Mode

The Ramp and Taper Mode is designed to deliver infusions with gradual ramp up and
taper down rates. The pump automatically calculates the rate increase and decrease
required to match the total volume, time and ramp up/ramp down time parameters. It
consists of 3 phases.
• Ramp phase: the pump rate is linearly increased until it reaches a
predefined rate (plateau rate) in a predefined time (Up-Time)
• Continuous phase: the plateau rate is used as a continuous infusion
• Taper phase: the pump rate is decreased linearly after the continuous
phase until the KVO rate is reached or pump is stopped in a predefined
time (Down-Time)
Example:
Ramp and Taper should only be performed by an experienced user that is

familiar with the principles of the Ramp and Taper function and properly trained
in using the present device.
Note: The active Ramp and Taper function is always symbolised with an charac-
teristical symbol in the Display ( / / ).
Note: Bolus function is disabled for Ramp and Taper Mode.
Set Profile Parameters: The therapy can be started directly via the drug library or via
the Main Menu/Special functions.
Starting Ramp and Taper via Drug Library:
Note: Ramp and Taper settings have been configured in the Drug List Manager
before and have been uploaded into the pump.
• Switch on pump with o and wait until self-check is finished.
36
SPECIAL FUNCTIONS
Chapter 3
• Insert disposable and use the drug library according to the Instructions for
Use.
The pump now lists the possible therapy profiles.
• Select “Ramp and Taper Mode” with t and press l.
The therapy settings for “Ramp and Taper Mode” are shown on the display.
• To change the values, press l to change and k to confirm.
The pump can be started now by pressing f
s.
Starting Ramp and Taper via Special Function Menu:

• Insert disposable.
• Go to Special Functions Menu and select Ramp and Taper.
• Press l to enter parameters and k to confirm.
• After entering all desired parameters the pump can be started by pressing f
s.
The status of the therapy is shown in the upper part of the display of the pump
by the icon for “Ramp and Taper Mode”.
The screen shows the following:
Ramp phase
The pump now linearly
increases the rate in the
predefined time until it
reaches the plateau rate and
then automatically switches
to continuous phase.
Continuous phase
The pump continuously infuses
the same rate for a predefined
time and then automatically
switches to taper phase.
Taper phase
The pump linearly decreases the
rate in the predefined time
until it reaches the KVO rate
Note: After starting infusion it is only possible to change rates, time and VTBI in
the continuous phase.
37
SPECIAL FUNCTIONS
Chapter 3
By editing (increasing/decreasing) the plateau rate, the therapy is recalculated. With

the increase/decrease of the plateau rate the volumes in the ramp phase, the conti-
nuous phase and the taper phase are increased/decreased. The continuous phase is
shortened/prolonged to infuse the VTBI still completely with the end of the taper
phase.
By editing the Ramp/Taper-Time, the therapy is recalculated. The Continuous Phase is
extended/shortened to infuse the VTBI still completely until the end of the Taper
phase.
By increasing/decreasing the VTBI, the continuous phase is prolonged/shortened to
infuse the new entered VTBI completely with the end of the taper phase.
Note: The delivery of drugs can be stopped and started again in Ramp and Taper
Mode at any time by pressig fs. Ramp and Taper is stopped immediately
without Taper phase and started without a new Ramp phase.
Immediate Taper Down
By chosing the Immediate Taper Down Function the therapy can be ended with a taper
phase before the originally defined VTBI is completely infused.
• Press C during continuous phase.
• Use t to select Special Functions and press l.
• Select Immediate Taper Down Function and confirm with l.
• Edit taper time by using t and press k to confirm.
The pump automatically changes to Taper phase and linearly decreases the
rate.
3.9 Program Mode

Program Mode is for infusion requiring a non-standard delivery pattern. The user
defines a series of intervals (max. 12 intervals) by certain parameters (rate, time,
volume) for each cycle.
The pump automatically gives each programmed period, one after the other.
38
SPECIAL FUNCTIONS
Chapter 3
Example:
Program Mode should only be performed by an experienced user being familiar with
the principles of the Program Mode function and properly trained in using the present
device.
Note: The active Program Mode function always displays this icon in the Display
( ).
Note: Bolus function is disabled for Program Mode.
Starting Program Mode via Drug Library:
Note: Program Mode settings have been configured in the Drug List Manager
• Insert disposable and use the drug library according to Instructions for Use.
• Select Program Mode with l.
In the following screen the user has to confirm the number of steps for the
therapy with k.
The settings for the steps of the infusion are shown on the display. These
settings, configured in the Drug List Editor, need to be confirmed with r.
• To change the values, press l to change and k to confirm.
39
SPECIAL FUNCTIONS
Chapter 3
• Adjust VTBI with q.

s.
Starting Program Mode via Special Function Menu:

• Go to Special Functions Menu and select Program Mode.
• Adjust VTBI with q.
After entering all desired parameters the pump can be started by pressing f
s.
In the upper part of the display the icon for “Program Mode” appears.
The screen shows the following:
The pump infuses the
predefined rate in the
predefined time for the current
step.
Only the VTBI may be changed during an infusion that is running.

• Press C to check upcoming Program Mode intervals in Main Menu.
It is possible to cancel one step of the running therapy. All following steps in
the programmed sequence persist.
• Go to Main Menu by pressing C.
• Use t to navigate through the Main Menu and select Current with l.
• For checking upcoming intervals press C.
• Select "Program Parameters" with l.
• Go through all interval steps with r.
Note: The delivery of drugs can be stopped and started again in the Program
Mode at any time by pressing fs.
Number of cycles is defined by VTBI. Take care to set the VTBI in the correct
relation to the volume of one Cycle. VTBI may needs to be adjusted after
Changing the intervals.
The Main menu informs about the current interval. The configured parameters
can be checked by Program Parameter Menu in Main.
3.10 Intermittent Mode

The Intermittent Mode consists of 2 phases. This phases will be repeated.
40
SPECIAL FUNCTIONS
Chapter 3
• Bolus phase: the configured bolus is active

• Rate phase: time during the therapy in which the entered rate is active
Example:
Intermittent Mode should only be performed by an experienced user being familiar

with the principles of the Intermittent Mode and properly trained in using the present
device.
Note: The active Multi Dose Mode function always displays this icon in the Display
( ).
Note: Regular Bolus function is disabled for Intermittent Mode.
In Intemittent Bolus the bolus service settings are active. The pressure level is
automatically set to max value.
Starting Intermittent Mode via Drug Library:
Note: Intermittent Mode settings have been configured in the Drug List
Manager before and have been uploaded into the pump.
• Insert disposable and use the drug library according to Instructions for Use.
The pump now offers the possible therapy profiles.
• Select “Intermittent Mode” with t and press l. The therapy settings for
“Intermittent Mode” are shown on the display.
• For changing the parameters, press l to change and k to confirm.
41
SPECIAL FUNCTIONS
Chapter 3
Note: Bolus rate is calculated by editable parameters. These parameters have to

be checked by the user before starting the infusion.
s.
Starting Intermittent Mode via Special Function Menu:

• Switch on pump with f s and wait until self-check is finished.
• Go to Special Functions Menu and select Intermittent Mode.
After entering all desired parameters the pump can be started by pressing f
s.
In the upper part of the display the icon for “Intermittent Mode” appears.
In bolus phase the screen shows the following:

The pump now delivers the
predefined bolus.
After the bolus phase the pump switches to rate phase and the screen shows
the following:
The pump now delivers the
predefined rate.
Note: To cancel bolus infusion in the Intermittet Bolus therapy at any time it is
only possible with f
s.
Note: The delivery of drugs can be stopped and started again in the Intermittent
Mode at any time by pressing fs.
During infusion it is possible to change the bolus volume, amount, VTBI as well
as the time interval.
• Press C.
• Use t to navigate through the parameter list and select the parameter to
be changed with l.
• Enter the new value and press k.
The pump continues infusion.
Changing the bolus after start:
If the user edits the bolus the therapy progression changes.
• Press C.
42
SPECIAL FUNCTIONS
Chapter 3
• Use t to select Bolus and press l.

• Change Bolus by using t and press k to confirm.
The pump automatically recalculates all other settings of the therapy.
Changing the time interval after start:

If the user edits the time interval the therapy progression changes.
• Press C.
• Use t to select Interval and press l.
• Change Interval by using t and press k to confirm.
The pump automatically recalculates all other settings of the therapy.
3.11 Dose Over Time

Dose Over Time is used to administer a specific dose of antibiotics in a specific
time. Dose Over Time is an own therapy and cannot be used in combination
with another therapy except Piggyback. It can only be activated via the Drug
List Manager. It can be used for standard infusion and/or piggyback.
The active Dose Over time function is always symbolised with a characteristical
symbol in the Display ( ). If besides DOT the piggyback therapy is active, a
combined symbol for both therapies will be displayed ( ).
Note: Dose Over Time should only be performed by experienced users being
familiar with the principles of the Dose Over Time function and properly trained
in using the present device.
The infusion rate in Dose Over Time can not be changed. This parameter is a
result of the total dose and the infusion time setting. Directly, after the Drug
selection, the infusion time and the total dose intended to be infused have to be
set. If the drug library contains default values for these parameters, the default
values are used as preset values.
If changes are necessary during infusion, the delivery can be controlled by
changing the time. The pump calculates the new rate by using the remaining
total dose and the remaining time. In the Main Menu total dose, time and VTBI
can be changed, also during RUN-Mode. Other parameters (dose rate, basal rate,
concentration, patient weight and patient height) cannot be changed.
Note: The KVO function and Bolus function are disabled during Dose Over Time.
Note: The feature Dose Over Time always requires the usage of dosing units (i.e.,
mg or mg/kg patient weight).
Before using Dose Over Time contact your local B. Braun representative!
Starting Dose Over Time via Drug Library:
Note: Dose Over Time settings have been configured in the Drug List Manager
43
SPECIAL FUNCTIONS
Chapter 3

• Insert disposable and use the drug library according to the Instructions for
Use.
• Select a drug by using t and press l.
The pump now offers the possible therapy profiles. Select “Dose over Time” with t and
press l.
The editor for Total Dose is shown if a drug with therapy Dose over Time is sel-
ected from drug library and no default value for Total Dose was entered in libr-
ary. The editor is also shown if the Total Dose is edited in the Main menu.
Enter the total dose, if necessary,

and confirm with k.
The editor for Time is shown if a drug with therapy Dose over Time is selected
from drug library and no default value for Time was entered in library. The editor
is also shown if the Time is edited in Main Menu.
Enter the time, if necessary,
and confirm with k.
The VTBI is calculated automatically and the following screen is displayed:

Check calculated rate by using
t for plausibility
Start Dose Over Time by
pressing f
s.
Run Menu: The time is used to

control the therapy. For this
reason the remaining time is
shown big digits in menu Run.
The parameter in the lower left
corner can be scrolled. Set to
Rate when leaving the pump.
Note: It is always possible to press the key C in the Run Menu and edit or
check values in the Main Menu while the pump is delivering.
44
AUTOPROGRAMMING
Chapter 4
A U TO P R O G R A M M I N G
Note: All normal pump functions remain in place when orders are received via
autoprogramming.
The pump can accept drug orders wirelessly from the EHR system or from
SpaceStation with SpaceCom. The workflow to accept an order wirelessly will
vary depending on your EHR vendor.
• Using the hand held device or lap top, review the order and follow your hospital
protocol for scanning the bag/syringe, pump, patient and nurse (optional).
• Once order is confirmed on the hand held or laptop, prompt EHR to send order
directly to pump. The order will arrive and appear on the pump within 10 seconds.
• Ensure pump is in the Main Menu, passive mode or Standby.
• New Order message will appear with drug name and mode.
• Press k to accept or c key to cancel order and respond to prompt.

• Select Care Unit and Patient Profile as in Drug Library programming.
• Pump will search for Drug Library match.
Note: If no drug library match, which may be due to no matching name,
concentration or dosing units, pump displays reason for no match and depending on
your hospitals configuration either allows manual programming outside the drug
library or rejects order completely. An order that is confirmed outside the drug library
will have a triangle with an exclamation point on display to indicate there are no drug
library settings.
• Scroll to each value to confirm using q arrow keys.
45
AUTOPROGRAMMNG
Chapter 4
Note: Order may be cancelled prior to confirming order.
• Once all values are confirmed, the Main Menu is displayed.

Note: Soft Limit alert will be issued if value exceeds any soft limits set in drug
library, soft limit may be overridden or value re-programmed per institutional
policy. Order will be rejected if hard limit is exceeded. (except in circumstance
where pump service program is not set to perform drug library match for auto-
programming).
For PRIMary Orders (Either 'Continuous' oder 'Dose over Time'):
Note: The first order sent send as 'Continuous' is always considered as the
PRIMary infusion, subsequent orders will be considered PIGGYback.
Note: Order sent as 'Dose over Time' is always considered the PRIMary infusion,
no subsequent order can be received. Additional, no updates can be received for
'Dose over Time'.
• Press Start/Stop key f
s to start infusion.
Updates to Current Primary Infusion

Updates may be received for PRIMary infusions while pump is running or stopped and
while in PRIMary or PIGGYback.
While in PRIMary:
• Update icon will appear on display, follow on screen prompts to accept or cancel
the order. Confirmation screen will indicate both OLD and NEW value for
parameter(s) that changed.
46
AUTOPROGRAMMING
Chapter 4
While in PIGGYback:
• Message will appear on top of display indicating update is available for PRIMary.
• Press M key to view order.
• Follow prompt, pressing f
s to accept order or c key to cancel and hold order for
later.
New Primary Infusion:

• To accept a new PRIMary order, stop infusion and clear current PRIMary infusion by
pressing c key and responding “yes” to clear current infusion.
PIGGYback Orders:
Orders received after PRIMary has been set will be for PIGGYback infusions,
follow prompts on screen to stop the PRIMary to accept the PIGGYback order.
• Confirm order values as above for PRIMary orders.

• Respond to prompts to check bag height and clamps prior to startingPIGGYback.
New PIGGYback order while PIGGYback is Infusing:

• Follow display prompts to stop current infusion.
Note: A PIGGYback order may be held for later by pressing c key to cancel
order and answering yes to “hold for later”.
47
AUTOPROGRAMMNG
Chapter 4
Note: Changing values on any incoming order may only be done after confir-
ming all values. Once all values are confirmed you may scroll to any value and
open editor with l to change value. Alternately, order may be cancelled and
request made for revised order to be sent.
Note: If pump is placed in standby while order is pending new order will flash
on top of stand by display, press M key to accept order (pump will come out of
standby).
48
OPTIONS
Chapter 5
OPTIONS
The options functions may be selected and changed while the pump is infusing or
stopped. To edit a menu item, select “Options” in the Main Menu and press l.
Then select desired function with t and follow the Instructions for Use as described.
5.1 Occlusion Pressure

The higher the pressure level is set at, the higher the pressure level must rise before
triggering an occlusion pressure alarm.
Using the occlusion pressure, the alarm sounding period can be kept short in the event
of system occlusions. It generally applies that the set pressure should always be set
higher than the system pressure. If pressure alarms occur in a pressure level without a
system occlusion, the pressure level must be adjusted upward. In order to be able to
ensure short alarm times, a low pressure level should be started with and the pressure
level increased until the infusion starts up.
Depending on the different influences, such as the tube length, tube diameter, viscosi-
ty of the liquid and the filter used in the system set-up, adjustments may need to be
made to the pressure level..
• Enter pressure in Options Menu by pressing l.
• Choose between nine pressure levels (1=lowest level; 9=highest level) by
pressing l or r and confirm entry with k.
The top line is the current

infusion pressure. The buttom
dashed line shows the pressu-
re alarm setting, currently 5
out of 9 which is represented
by 5 dashed. The picture
shows a current presure of
~ 30% of the pressure level 5.
5.2 Upstream Occlusion Pressure

The device is equipped with an upstream pressure sensor that detects an
occlusion (e.g. closed roller clamp, kinked line) between the container and the
pump. The higher the pressure level is set at, the lower the pressure level must
drop before triggering an upstream occlusion pressure alarm.
• Access upstream pressure in Options Menu by pressing l.
• Choose between nine pressure levels (1=lowest level; 9=highest level) by
pressing l or r and confirm entry with k.
49
OPTIONS
Chapter 4
5.3 Data Lock

The data lock function protects the device against unauthorized access. It is
recommended to adapt the four digit code for level 1 and 2 from the default
setting (9119), using the service program. There are three security levels.
Level 1:
A modification of values as well as a bolus application are not possible but a
change of the disposable can be conducted. It is possible to navigate through all
menus and status data can be checked. Starting, interrupting and switching the
pump off is possible.
Level 2:
This level has the same performance characteristic as described under level 1
and additional will not allow the change of disposable. In order to prevent a
data lock alarm the correct code must be entered within 20 sec after the pump
was stopped. Changing the disposable and switching the pump off is only
possible after the code was entered.
Level 3:
This level will allow starting and stopping the pump as well as switching off.
The code for this level may be different for each drug and is defined in the drug
list. A change of the disposable, however, is possible by using the code defined
for the other levels. An overview about the differences between the levels 1, 2
and 3 is given by the following table.
Event Level 1 Level 2 Level 3
Change of disposable  O  with code for
level 1/2
Start of infusion  O 
Change of parameters O O O
Stop of infusion  % 
Switching off pump / Standby  O O
PCA bolus with pump-based bolus button O O 
Customisable screen O O 
Acoustic feedback of demanded boli O O 
Indicates denied PCA boli   O
= possible | O = not possible | % = followed by standby-alarm
Activation of the function:

• Open data lock in Options Menu with l.
50
OPTIONS
Chapter 4
• Select between level 1, 2 or 3 (if activated) with l and r and confirm
with k.
• Enter code with q and press k in order to activate data lock.
Changes to the protected values and the bolus function which are marked with
y are only possible after entering the code. After 20 sec in the Main Menu,
Status Menu, Special Functions Menu and Options Menu the lock will be acti-
vated again. If the wrong code is entered twice the pump will switch into the
last menu. If the wrong code is entered twice again the pump will go into an
audible alarm, a nurse call will go off and the yellow LED blinks. If a target
value was reached while data lock is active a new start of the pump is only
possible after entering the code.
In order to deactivate the function, select “Off” in the data lock, press k, enter
the code and press k again.
5.4 Bolus Rate

• Open bolus rate in Options Menu with l.
• Change bolus rate with q and confirm setting with k.
Note: Set bolus rate according to therapy requirements. Take care not to overdose!
Given a bolus rate of 1200 ml/h, e.g. 0.33 ml are reached within just one second.
5.5 KVO-Mode
The pump can continue the infusion with a preset KVO-rate after a preselected
VTBI/time has passed (see "Technical Data"). The duration of the KVO delivery is
selected in the service program.
• Open the KVO-mode in the Options Menu with l.
• Answer the Yes/No question with u to enable the KVO-mode.
5.6 Contrast / Display Light / Keypad Light

Contrast as well as display- and keypad light can be adjusted individually according to
the lighting conditions.
• Open contrast/display light/keypad light in Options Menu by pressing l.
• Choose between 9 contrast- and display light levels with l or r and confirm
with k.
51
OPTIONS
Chapter 5
5.7 Alarm Volume
Chose between 9 different alarm volume levels.
• Open alarm volume in Options Menu with l.
• Set volume with l or r and confirm entry with k.
5.8 Date / Time

• Open date/time in the Options Menu with l.
• Modify date and time with q and confirm the setting with k.
5.9 Macro Mode

The infusion rate appears larger on the display when the macro mode is activated and
the pump is infusing.
• Open macro mode in Options Menu with l.
• Answer Yes/No question by pressing u to activate the macro mode.
For quick activation of macro mode: Press and hold r while the pump is infusing
until the font size changes.
5.10 Language
This function enables a change of the pump language.
• Open language in the Options Menu with l.
• Select language with t then press l.
• Confirm Yes/No question with u.
52
ALARMS
Chapter 6
ALARMS
The Infusomat® Space is equipped with a audible and optical alarm signal.
Alarm- Audible Optical signal Staff call User confirmation
type signal Red LED Yellow LED Text
Device yes flashes off device alarm yes Press O and follow
Alarm and alarm the instruction on the
code display.
(see service
program)
Opera- yes flashes off see alarm de- yes Press k to
tingA- scription acknowledge the
larm audible alarm, alarm
text and staff call.
Press C to mute the
alarm for
2 minutes.
Pre- yes off constant see alarm de- (de-)activate Press C to mute
Alarm on scription via service alarm and turn off
program staff call. Visible
alarm remains until
end.
Remin- yes off constant see alarm de- yes Press k to mute
der on scription alarm, turn off staff
Alarm call and delete the
alarm text.
Alarm no off off see alarm de- no Hint disappears
Hint scription without
confirmation.
6.1 Device Alarms
When a device alarm occurs the infusion is immediately stopped. Press o to switch
off the device. Then switch the device on again. In case of a repeated device alarm you
must close the rollerclamp, disconnect from the patient, open the front door of the
pump and take out the disposable. The device needs to be handed to the service
department.
6.2 Pre-Alarms and Operating Alarms

Pre-alarms:
Pre-alarms occur a few minutes (dependable on service settings) prior to operating
alarms. During pre-alarms an audible tone sounds, the yellow LED is constantly on and
a staff call is activated (optional). The display message varies depending on the alarm
reason. The signal tone and the staff call are turned off with C . Display and LED stay
in pre-alarm until the operating alarm goes off. Pre-alarms don't lead to an
interruption of the infusion.
53
ALARMS
Chapter 6
Display message Pre-alarm reason

“VTBI near end“ The preselected volume is nearly infused.
“Time near end“ The preselected time is almost over.
“Battery nearly empty“ The battery is almost discharged.
“KVO mode“ VTBI/time are reached and the pump continues
the infusion at the KVO-rate.
A stopwatch on the display counts down the remaining time (depending on the
service program, between 0-30 min). After that, the pump changes to the
operating alarm.
The pre-alarms “VTBI near end“ (volume preselection) and “Time near end“ (time
preselection) can be deactivated via the service program.
Operating alarms:
Operating alarms lead to an interruption of the infusion. An audible tone
sounds, the red LED flashes and a staff call is activated.
The display states "Alarm", the reason for the operating alarm and gives the
option to either confirm the alarm by pressing k or mute the alarm by
pressing C. If the alarm is muted, the alarm message will remain on the
screen until it is confirmed by pressing k. After 2 minutes, if the alarm has
not been confirmed by pressing k, the audible tone will sound again. The
alarm tone, the alarm message, and the staff call (optional) are all cleared by
pressing k. Corrections are to be made according to the alarm reason.
Display message Alarm reason

“VTBI infused “ The preselected volume was infused.
Continue therapy or select new therapy.
“Time expired“ The preselected time has ended.
Continue therapy or select new therapy.
“Battery empty“ The battery pack is discharged.
Connect device with mains and/or exchange
battery pack. The battery alarm will be on for 3 min.
Then the pump will automatically turn off.
“Pressure high“ An occlusion occured in the system. The set pressure
level was exceeded. A bolus reduction is automatically
initiated by the pump.
Check if tubing contains kinks or is damaged as well
as IV- and filter patency.
Increase occlusion pressure if necessary.
“KVO finished“ The KVO-time has ended. Continue therapy or set new
therapy.
54
ALARMS
Chapter 6
Battery cover removed“ The battery cover is not properly engaged on the
battery compartment.
When pushing on the battery cover listen for “click”.
“Standby time expired“ The set standby time has ended.
Set new time or continue with previously set therapy.
“No battery inserted“ It is not possible to use the pump without a
battery pack.
Turn off pump and insert battery pack according
to description “Overview Infusomat® Space“.
“Drive blocked“ Stepper motor does not deliver due to excess pressure
in the system.
Interrupt patient connection and reinsert the line.
“Calibrate device“ Pump calibration data have changed (e.g. after an
update).
Recalibrate device via the service program.
“Drop sensor connection“ Contact to the drop sensor is interrupted while the
pump is delivering.
Check whether the drop sensor is correctly placed on
the drop chamber. If necessary, replace the drop
sensor or preselect VTBI/time and proceed with
therapy.
“Check upstream“ The upstream sensor triggers an alarm.
Check if roller clamp is closed or infusion line is
kinked. If a drop sensor is connected the upstream
alarm is deactivated.
“Air bubble "/"Accumulated air“ Air inside the system.
Check the line for small air bubbles and disconnect
from patient to repeat priming, if necessary.
“No drops“ The drop sensor does not detect any drops.
The infusion container is empty, the roller clamp is
closed, the drop sensor is not put on, check the line
for obstructions, condensation on drop chamber
(remove by shaking it).
"Too few drops" The number of fallen drops is lower than the preset
rate.
A negative pressure in a glass infusion container can
be eliminated by opening the vent flap on the drop
chamber. Check whether the infusion bottle is empty,
the roller clamp is completely opened and whether
there are any kinks in the line.
"Too many drops" The number of fallen drops is higher than the preset
rate.
55
ALARMS
Chapter 6
Check the line for damage and make sure that the
line is correctly inserted.
"Flow" Drop chamber is completely filled or leak in the
system.
Examine the line for damage and check the drop
chamber.
“Data were reset” Therapy and pump settings could not be restored.
Enter therapy again.
"Therapy data were reset" Therapy data could not be restored.
Enter therapy again.
“Data Lock" An attempt was made to stop or switch the pump off
without entering the code.
Enter the correct code in order to continue the
therapy respectively turning the pump off.
The red LED extinguishes with the acknowledgement of the alarm.
Caution: If a wrench ( ) is displayed and/or a yellow, red and blue LED blink
then the pump is in the service mode and is not permitted to be used on a patient. The
pump must then be checked by a service technician.
6.3 Reminder Alarms

Reminder alarms only occur in two cases:
1. A line is inserted, the pump does not deliver, no value is edited and the device is not
operated for two minutes.
An acoustic tone sounds, the yellow LED is constantly on and a staff call is
activated.
a) The display states “Reminder alarm!”
b) The display states “Config. not finished!”
Confirm alarm with K and continue to set therapy/Start Up configuration.
2. A value edition was started but not finished and confirmed. This is also possible
with a missing disposable.
An acoustic tone sounds, the display states “Value not accepted“, the yellow LED
is constantly on and a staff call is activated.
Confirm alarm with K and continue to set therapy.
6.4 Alarm Hints

If inproper entries are made the display states corresponding hints (e.g. “Bol.rate out of
range”; “Download failed”; “The parameter can not be modified”).
56
BATTERY OPERATION AND MAINTENANCE
Chapter 7

The battery has an operating lifetime of 4 hours at 100 ml/h when new. For optimal
treatment of the battery, the device is equipped with protection against overcharge
and deep depletion. The battery pack is charged by the pump during connection to
mains. When disconnected from mains or in case of power failure, the pump
automatically switches to battery power.
Note: Prior to a longer storage of the pump (> 5 months) the battery pack must be
completely charged and then removed from the pump. Before changing the battery,
always disconnect the pump from the patient and switch off the device.
The battery status indicator is a trend display (low, medium, high). For more detailed
information on the current battery capacity (operating time in hours and minutes)
please refer to menu item “Batt. Cap.” in the Status Menu of the Infusomat® Space.
Caution: The display of the battery operating time on the pump is an approximate va-
lue based on the current delivery rate. Changes in the delivery rate may affect the bat-
tery operating time.
Disposable change procedures require a high power consumption. A sudden break
down of the battery operating time can be possible with an aged battery. In this case
the battery has to be replaced by a new one.
If highly potent drugs are to be given over an extended time without mains power, it is
recommended to have a fully charged reserve pump at hand.
Note: In case of ESD, Pump may need plugged into wall outlet to re-start the battery.
Attention: If the battery module is stored for long periods of time outside the pump, it
is recommended to fully charge the battery and store it at room temperature.
Caution: Batteries may explode or leak if they are opened or incinerated. Consider dis-
posal directions!
Important information for battery self-check:

If the battery symbol is blinking during mains operation, the battery has less then 30
minutes remaining capacity.
In this case, the pump should not be disconnected from mains. If it is necessary to dis-
connect the pump from mains power for urgent reasons, the user should check to en-
sure if the battery capacity is sufficient for the proposed use. When the battery symbol
blinks permanently (>1h), the battery must be checked by a technician and replaced if
necessary.
Directions for optimal battery use:

The actual battery life may vary due to
• ambient temperature
• varying load (e.g. frequent boluses).
57
Chapter 7
The optimal life time of a battery pack will only be reached if it's completely
discharged from time to time. A maintenance mode which conducts this battery
maintenance is built in. This function should be activated once a month. Furthermore:
• If a battery, which is not completely discharged, is charged several times, its
capacity can be reduced.
• Under normal temperature conditions a battery can be charged and discharged
approx. 500 times before its lifetime decreases.
• When the pump is not connected to mains power the battery discharges itself
slowly. This can occur even when the pump is not operating.
• The battery operating time can only be realized if the pump operates
continuously with a fully charged battery at room temperature.
Battery maintenance:
To accurately balance the battery capacity a cyclical battery maintenance is necessary.
The frequency of battery maintenance may be set in the service tool. The battery main-
tenance mode detects a possible capacity loss (e.g. through ageing of the battery pack)
and then the capacity/running time will be calculated anew. After a longer
storage time or a longer operation without battery maintenance it can happen that
the battery pre-alarm time can no longer be maintained. In this case it is necessary to
perform a battery maintenance.
To initiate the discharge process the message „Battery maintenance“ and the k-key
will be displayed after switching the pump off. By pressing k and u the discharge
process will start. The process is interrupted by switching the pump on again. If the
battery maintenance is to be continued a new activation is necessary. After completely
discharging the battery it will be completely charged again. The total duration of the
battery maintenance process takes approx. twelve hours.
Caution: Please take into account that, if the battery maintenance has not been
completed there is a possibility of a reduced battery operating time.
Replacing batteries:
The Battery Pack SP can be exchanged by any user. No special qualification is required.
All rechargeable batteries exhibit a reduction in capacity as they age. This aging is de-
pendant on several factors including charging cycles, temperature and battery usage.
It is recommended to periodically check the function of the battery. A battery should
no longer be used if a change of disposable leads to a “Battery nearly empty“ or a “Bat-
tery empty“ alarm when it is fully charged.
Caution: Batteries may explode or leak if they are opened or incinerated. Consider
disposal directions!
58
START UP GRAPHS AND TRUMPET CURVES
Chapter 8
START UP GRAPHS AND TRUMPET CURVES

Start Up Graphs Trumpet Curves
The graphs show the accuracy/uniformity of flow in relation to time. They allow
for the following:
The delivery behaviour or delivery precision is essentially influenced by the type
of the disposable used. Deviations from the technical data of the pump cannot be
guaranteed as the manufacturer may change IV-set specification significant to
system accuracy without prior notification.
System accuracy is +/- 5% typical by volume as measured using the trumpet
curve test method defined in IEC 60601-2-24 at rates of 1ml/h (23°C) and when
the pump is used with recommended sets.
Trumpet Curves
Measured values for second hour in each case.
Measurement interval ∆t = 0.5 min
Observation interval p x ∆t [min]
Start Up Graphs
Measurement interval ∆t = 0.5 min
Measurement duration T = 120 min
Flow Qi (ml/h)
59
TECHNICAL DATA
Chapter 9
T E C H N I C A L D ATA
Type of unit Volumetric infusion pump

Classification (acc. to IEC/EN 60601-1) defibrillator-proof; CF equipment
Protective Class II; Protective Class I in
combination with SpaceStation
Class (acc. to Directive 93/42 EEC) IIb
Moisture protection IP 22 (fluid protected for horizontal usage)
External power supply:
• Rated voltage Via B. Braun SpaceStation or optional
mains adaptor (rated voltage 100 … 240 V
AC~, 50/60 Hz) for stand alone operation
• External low voltage 11 … 16 V DC via Connection Lead SP
12 V or via SpaceStation
Staff call Max. 24 V / 0,5 A / 24 VA (VDE 0834)
EMC IEC/EN 60601-1-2 / 60601-2-24
Time of operation 100 % (continuous operation)
Operating conditions:
• Relative humidity 30 % … 90 % (without condensation)
• Temperature +10 … +40 °C
• Atmospheric pressure 500 … 1060 mbar
Storage conditions:
• Relative humidity 20 % … 90 % (without condensation)
• Temperature -20 … +55 °C
• Atmospheric pressure 500 … 1060 mbar
Type of battery pack (rechargeable) NiMH
Operating time of rechargeable battery Approx. 4 hours at 100 ml/h
Recharging time Approx. 6 hours
Weight Approx. 1.4 kg
Dimensions (W x H x D) 214 x 68 x 124 mm
Volume preselection 0.1 - 99.99 ml in increments of 0.01 ml
100.0 – 999.0 ml in increments 0.1 ml
1000 – 9999 ml in increments 1 ml
Time preselection 00:01 – 99:59 h
Accuracy of set delivery rate ± 5 % according to IEC/EN 60601-2-24
Max. Volume in case of single fault
condition For incorrect dosages of 1,4 ml due to
malfunctions of the device the pump will
automatically shut off
Technical inspection (safety check) Every 2 years
60
TECHNICAL DATA
Chapter 9
Administration Set Change Interval Pumping accuracy is maintained for a

minimum of 96 hours.
Multiple lines connected to one Connecting multiple infusion lines with
patient port different flow rates may affect the rate
for all infusions past the point of
connection.
Rate increments 0.1 - 99.99 ml/h in increments of
0.01 ml/h
100.0 - 999.9 ml/h in increments of
0.1 ml/h
1000.0 - 1200 ml/h in increments of
1 ml/H
Accuracy of bolus infusion typ. ± 5 % as of a bolus volume > 1 ml
KVO-rate Delivery rate ≥ 10 ml/h: KVO-rate 3 ml/h
Delivery rate < 10 ml/h: KVO-rate 1 ml/h
Delivery rate < 1 ml/h: KVO-rate =
set rate (default setting 0.1 ml/h)
Computer connection USB connection in combination with
B. Braun interface lead CAN SP
(8713230) including electrical
insulation. Please pay attention to
safety notices.
Air detector Technical sensitivity:
Detection of air bubbles ≥ 0.01 ml
Alarm triggering:
Single bubble alarm: 0.02 – 0.3 ml
(default 0.3 ml)
Cumulative air alarm: 0.5 – 3.8 ml/h
(default 1.5 ml/h)
Resolution: 0.01 ml
Sensitivity upstream sensor 9 levels from -0.12 bar to -0.21 bar
(pressure reduction)
Occlusion alarm pressures 9 levels up to 1.2 bar
Occlusion pressure Time to occlusion alarm [min] at rate
[bar] [1 ml/h] [25 ml/h] [100 ml/h]
Level 1 typ. 0.3 09:07 00:33 00:07
Level 5 typ. 0.7 25:53 01:14 00:15
Level 9 typ. 1.2 46:50 02:06 00:24
Max. bolus after bolus reduction ≤ 0.2 ml
Alarm volume 9 levels from 1 (59dBA) to 9 (74dBA)
61
TECHNICAL DATA
Chapter 9
Mechanical occlusion pressure limit

under fault conditions Occlusion alarm pressure max. 2.1 bar
(210 kPa).
Maximum posts occlusion bolus volume
2ml.
History protocol > 3000 last history entries
100 events for system diagnose.
Refer to separate documents of the
History Viewer for closer information.
• Use only pressure proof and compatible disposable items (min. 2 bar/1500 mm Hg)
to avoid influencing performance data - which would result in impairing patient
safety.
• Only use combined with approved devices/accessories by the manufacturer,
otherwise this may lead to higher emission or reduced immunity.
• Use only compatible combinations of equipment, accessories, working parts
and disposables with luer lock connectors.
Essential Performance for Infusion pumps:
• Infusion of liquids without variation of infusion rate
• Pressure limitation as protection from the bursting of the infusion line
• Protection from air-infusion
• Protection against unintended bolus volumes and occlusion (added by IEC
60601-2-24)
• Alarm signal of high priority (added by IEC 60601-2-24)
Note: The technical data stated in this Instructions for Use manual were
determined with the Infusomat® Space lines as of "Type Standard" (870 0036 SP).
These technical data can change when using set configurations.
62
TECHNICAL DATA
Chapter 9
EMC (ELECTROMAGNETIC COMPATIBILITY)

Guidance and manufacturer’s declarartion on electromagnetic compatibility
Guidance and manufacturer’s declaration – electromagnetic emission

The Space System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Space System or any component should assure that it is used in such
an environment.
Emissions test Compliance Electromagnetic environment guidance

RF emissions Group 1 The Space System uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
If WLAN-Module is installed within Battery module
(8713182A) or WLAN USB Stick for SpaceCom
(8713185) is used RF energy is transmitted by the
Space System.
Refer to technical data of Battery-Pack SP with Wifi
IUF and/or SpaceStation and SpaceCom for details.
RF emissions Class B (Note 2) The Space System or any component is suitable for
CISPR 11 use in all establishments, including domestic
establishments and those directly connected to the
Harmonic applicable only for public low-voltage power supply network that
emissions SpaceStation supplies buildings used for domestic
IEC 61000-3-2 purposes.
Class A
Voltage fluctuations / Complies

flicker emissions
IEC 61000-3-3
Note 1: Maximum emissions are measured with a complete system (SpaceStation and components).
Note 2: If Class A equipment is attached to the Space System, the Space System will become Class
A too. This equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the
Space System or shielding the location.
63
TECHNICAL DATA
Chapter 9
Guidance and manufacturer’s declaration – electromagnetic immunity

The Space System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Space System or any component should assure that it is used in such
an environment.
Immunity test level Compliance level Electromagnetic
test IEC 60601-1-2 environment – guidance
IEC 60601-2-24
Electrostatic contact ±6KV no disturbances Floors should be wood,
discharge (ESD) IEC 60601-1-2: concrete or ceramic tile.
according IEC ±6KV ±8KV stop with alarm If floors are covered with
60601-4-2 IEC 60601-2-24: possible synthetic material, the relative
±8KV humidity should be at least
30 %.
air ±8KV no disturbances
IEC 60601-1-2:
±8KV ±15KV stop with alarm
IEC 60601-2-24: possible
±15KV
Electrostatic ± 2 kV for power ±2KV A/C power quality should be
transient / burst supply lines that of a typical commercial or
according IEC ±1KV hospital environment.
61000-4-4
± 1 kV for
input/output lines
Surge differential mode ±1KV A/C power quality should be
according IEC ±1KV that of a typical commercial or
61000-4-5 ±2KV hospital environment.
common mode
±2KV
Voltage dips, short < 5 % UT complies by use of A/C power quality should be
interruptions and (>95 % dip in UT ) internal battery that of a typical commercial or
voltage variations for 0,5 cycle hospital environment. If the
on power supply user of the Space System
input lines 40 % UT requires continued operation
according IEC (60 % dip in UT ) during long time A/C power
61000-4-11 for 5 cycles interruptions, it is
recommended that the Space
70 % UT System or component be
(30 % dip in UT ) powered from an
for 25 cycles uninterruptible power supply or
a battery.
< 5 % UT
(>95 % dip in UT )
for 5 sec
<5% UT
for 5 s
(>95% dip)
Power frequency 3 A/m 400 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
according IEC location in a typical
61000-4-8 commercial or hospital
environment.
Note: Different test values of IEC 60601-2-24 are marked in the table. At the test values no
dangerous disturbances occurred at the lower test values of IEC 60601-1-2.
64
TECHNICAL DATA
Chapter 9
Guidance and manufacturer’s declaration – electromagnetic immunity

The Space System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Space System or any component should assure that it is used in such
an environment.
Immunity test test level Compliance Electromagnetic

IEC 60601-1-2 level environment - guidance
IEC 60601-2-24
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Space System or it’s components,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended
separation distance
radiated IEC 60601-1-2:
electromagnetic 3 Veff normal and d = 1,2 √P
RF fields 10Veff in ISM Field strengths should be less then
according frequency band 10V/m
IEC 61000-4-6
IEC 60601-2-24: 10Veff d = 1,2 √P
10 Veff 150KHz to 80MHz 80 MHz to 800 MHz
150KHz to 80MHz
10 V/m d = 2,3 √P
radiated 10 V/m 80 MHz to 3 GHz 800 MHz to 2,5GHz
electromagnetic 80 MHz to 2,5 GHz
RF fields where p is the maximum output
according power rating of the transmitter in
IEC 61000-4-3 watts (W) according to the
transmit-ter manufacturer and d is
the rec-ommended separation
distance in meters (m).
Field strengths from fixed RF

transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
Interference may occur in the

vicinity of equipment marked with
the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 3: See next page.
65
TECHNICAL DATA
Chapter 9
NOTE 3: Different test values of IEC 60601-2-24 are marked in the table. At these test values no
dangerous disturbances are allowed while at the lower test values of IEC 60601-1-2. Field strengths
from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the location in which the
SpaceSystem is used exceeds the applicable RF compliance level above, the Space System should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Space System.
The Space System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Space System or component can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Space System as recommended below,
according to the maxi-mum output power of the communications equipment
rated power of the Separation distance according to frequency of transmitter

ratio transmitter m
W
150 kHz bis 80 MHz 80 MHz bis 800 MHz 800 MHz bis 2,5 GHz
1,2√P 1,2√P 2,3√P
0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,27
100 12 12 23
NOTE 1: For transmitters rated at a maximum power output not listed above, the recommended
separation distance (d) in meters (m) can be determined using the equation applicable to the frequen-
cy of the transmitter, where (P) is the maximum output power rating of the transmit-ter in watts (W)
according to the transmitter manufacturer.
NOTE 2: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the frequency range 0.15 MHz to 2.5 GHz to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently brought into
patient areas.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
66
WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 10
WARRANTY / TRAINING / TSC* / SERVICE /

DISINFECTING / DISPOSAL
Responsibility of the Manufacturer
The manufacturer, assembler, installer or importer is responsible for the effects
on safety, reliability and performance of the equipment only if:
• assembly operations, extensions, re-adjustments, modifications or repairs
are carried out by authorized personnel,
• the electrical installation of the relevant room complies with the
appropriate requirements (e.g. VDE 0100, 0107 and/or the IEC-publications
resp. national requirements),
• the equipment is used in accordance with the Instructions for Use and
• the Technical Safety Checks are carried out regularly.
The CE mark Warranty

confirms that this
medical product B. Braun provides 24 months warranty, as from the date of delivery, for every
complies with the Infusomat® Space (12 months for every Battery-Pack SP). This covers repair or
“Council Directive
replacement of parts damaged as a result of design/manufacturing errors or
on Medical Devices
material defects. Modifications or repairs to the unit undertaken by the
93/42/EEC” dated
14th Junde 1993.
user/operator or by third parties invalidate the warranty.
The warranty does not cover the following:
B. Braun Elimination of faults attributable to incorrect/unauthorized handling, or to
Melsungen AG normal wear and tear.
Defective rechargeable battery packs can be returned to B. Braun for further
disposal.
WARNING: Do not modify this equipment without authorization of the
manufacturer.
Separate collection for electrical and electronic equipment

(currently applicable to EU community only).
Training
B. Braun offers a training. Please ask your local representative for further
details.
67
Chapter 10
Technical Safety Check* / Service

The Technical Safety Check is recommended to be carried out every 2 years and
should be documented. Servicing work must be carried out exclusively by
trained personnel.
Check regularly
Check for cleanliness, completeness and damage. Use only according to
Instructions for Use. During an exchange interval of the disposable the pump
has to perform a self-test. Check the following items each time the pump is
switched on: self-check, audible alarm, process- and alarm control indication.
Disinfecting
Caution: Before disinfecting the pump, always disconnect the pump

from the patient, switch off the device and disconnect from power and
other devices (e.g. staff call).
Clean all exposed surfaces using a clean, soft, lint-free cloth dampened with a
mild cleaning solution of warm, soapy water. Make sure to remove any visible
residue from all surfaces prior to disinfecting. Do not spray disinfectants direct-
ly on the pump, use a soft, low lint cloth dampened but not saturated with pro-
duct. After cleaning allow device to dry for at least 20 minutes prior to use. The
line guide element can be removed using a pointed object (ballpoint pen) inser-
ted in the lower right corner. The cover can then be immersed, to be cleaned,
wipe “fingers” with a soft cloth. Wipe magnifying- and displayglas on front of
pump door only with a soft cloth.
Note: Do not use Hexaquart® or other alkylamine containing disinfectants.
Recommended: disinfectant for wiping available from B. Braun: Meliseptol®
Foam pure, Melsitt 10% and Melsept SF 10%.
Note: Keep instrument upright and do not allow any part of instrument to
become saturated with or submersed in fluid during cleaning operation.
Do not allow moisture or detergents to come into contact with the electrical
connections of the device (P2 or P3 connectors) or any device openings. To
68
Chapter 10
reduce the likelihood of moisture ingress into the electrical connectors, the P2
connector of a power supply or combi cable may be used to cover the
connections during cleaning operations. Ensure that any connectors used to
cover are not connected to a wall outlet or other electrical source. Once the
cleaning has been completed, remove the connector and inspect all connectors
for residual moisture and evidence of damage or breakdown to the plating on
the connectors. Allow any residual moisture to evaporate before plugging the
device into a wall outlet. Replace any connectors which exhibit damage or
evidence of plating breakdown prior to returning the device to service.
Utilize electrical contact cleaner that does not react with plastics to remove any
deposits of material which may be present inside the electrical connectors as
required.
Caution: Do not allow liquids to enter into or come into contact with
any openings or electrical connections on the pump or power supply.
Fluid exposure in these areas may result in the risk of short circuit,
corrosion or breakdown of sensitive electrical components, and/or
electrical shock. If fluid exposure occurs, the device should be swapped
out with another device in a manner that presents minimal interruption
to patient care. The device should remain unplugged until it can be
inspected by a trained technician for any evidence of damage and/or
residual moisture which may impair the function of the device.
Caution: Do not touch line guide element or peristalitic pumping area of

pump with sharp object.
When reinserting the line guide element, make sure that it is not damaged and
that it audibly locks in place.
Note: The use of unappoved cleaners and failure to follow the disinfection pro-
cedures and the manufacturer's recommended dilutions can result in an instru-
ment malfunction or product damage and could void the warranty.
Disposal
The pumps as well as battery packs can be returned to B. Braun for further
disposal. When taking care of disposing of disposables as well as infusion
solutions, please consider the applicable hygiene and disposal regulations.
Inspection on Delivery
Despite careful packaging, the risk of damage during transport cannot be
entirely prevented. Upon delivery, please check that all items are present. Do not
use a damaged device. Contact the service department.
Testing the proper funciton of the device should be performed before initial use.
69
Chapter 10
This is even ruled by law in several countries. A respective form can be obtained
from B. Braun.
Included in Delivery
Infusomat® Space, Battery-Pack SP, Instructions for Use-Set.
70
INSTRUCTIONS FOR USE ACCESSORY
Chapter 11

SpaceStation (8713140)
Station for up to four pumps. For further information see Instructions for Use of
SpaceStation.
SpaceCover Standard (8713147)

SpaceCover Comfort (8713145)
Cover to be placed on upper SpaceStation incl. built-in handle. The SpaceCover
Comfort additionaly includes a central alarm management and alarm LEDs.
PoleClamp SP (8713130)
A maximum of three B. Braun Space pumps and one SpaceControl can be
stacked together when used with the PoleClamp SP. For detailed instructions on
secure fixation of the PoleClamp SP please refer to "Overview Infusomat®
Space" and "Patient Safety".
Power Supply SP (8713110D - 8713123D)

The Power Supply SP is adequate to supply power for a single pump and one
SpaceControl.
1.) Connect plug of Power Supply SP with socket P2 on back of pump
(ensure that plug “clicks”).
2.) Push power plug into wall outlet.
Note: For disconnection from pump, press lever on plug down.
A maximum of three plugs can be stacked upon each other in socket P2.
Prior to use, visibly inspect the power supply and if reject if damaged.
Technical Data: 100 – 240V AC~, 50/60 Hz
Combi Lead SP 12 V (8713133)

The Combi Lead SP can connect up to three pumps. All pumps can then be
operated via the Connection Lead SP (12 V).
1.) Connect plug of the Combi Lead SP 12 V with the socket P2 on the
back of the pump.
2.) Connect plug of Connection Lead SP with Combi Lead SP.
3.) Push plug of Connection Lead SP into 12 V connector.
71
Chapter 11
Note: A maximum of three plugs can be stacked upon each other in socket P2.
Drop Sensor SP (8713175)

The drop sensor provides an additional safety function and is therefore
particularly recommended in connection with low delivery rates (1ml/h).
The connection of the Drop Sensor SP on the pump is located at the rear of the
device, in the lower left corner. At the time of delivery the port of the drop
sensor is protected by a cover. Use a screw driver to break off the cover for
further disposal.
Use holder on PoleClamp, in order to park the drop sensor.
Short Stand SP (8713135)

Use the Short Stand SP to attach an infusion container to the pump.
1.) Push the PoleClamp on the pump.
2.) Plug the short stand into the aperture on the PoleClamp; make sure
that it audibly locks in.
3.) To remove the short stand: Press the white button at the lower end of
the PoleClamp and remove the short stand.
Note: Use only one infusion bag with max. 1000ml on the short stand.
Note: Insure pump is properly secured before attaching fluid bag to short stand
and connecting to patient to assure pump cannot fall and harm patient.
Battery-Pack SP (NiMH) (8713180)

Battery-Pack SP (NiMH) incl. Pin (8713180A)
For further information on the Battery-Pack SP (NiMH) see “Battery Operation”.
Battery-Pack SP (LiIon) incl. Pin and WiFi (8713182A)

For further information see Instructions for Use of "Battery Pack SP with WiFi".
Interface Lead CAN SP (8713230)

Interface Lead CAN SP is needed in order to set up a connection between the
SpaceStation/pump and the computer outlet (for service requirements).
72
Chapter 11
1.) Push plug into socket F3 on the SpaceStation or P2 on the pump and
connect with the CAN/USB converter.
2.) Connect CAN/USB converter to computer outlet as described in the
Instructions for Use manual.
Caution: The Interface Lead CAN SP is only to be used by the service
department; never use while patient is connected.
Interface Lead RS232 SP (8713234)

Interface Lead RS232 SP is needed in order to set up a connection between the
Space pump and the computer outlet (for service requirements).
1.) Push plug into socket P2 on the pump and connect with the Interface
Lead RS232 SP.
2.) Connect Interface Lead RS232 SP to computer outlet as described in the
Instructions for Use manual.
Caution: The Interface Lead RS232 SP is only to be used by the service
department; never use while patient is connected.
Connection Lead SP (12 V) (8713231)
Install the Connection Lead SP (12 V) in the following way:

1.) Connect plug to socket P2 on back of pump or F3 on SpaceStation
respectively.
2.) Put the connection lead into the car socket.
3.) If necessary, remove red adaptor of motor vehicle connector by slightly
turning and simultanously pulling.
The green LED of the electronic box shows the operating voltage. The mains
connector can easily be replaced by another plug if required.
Caution: Do not connect the pump to a patient during external car battery
charging!
73
Chapter 11
Connection Lead for Staff Call SP (8713232)

To connect the Infusomat® Space to staff call, use the Connection Lead for Staff
Call SP. The staff call needs to comply with the requirements of VDE 0834
(consider country specific regulations).
Note: Test staff call signalling before every use.
The Infusomat® Space offers three different staff call operating modes. They are
displayed in the signalling scheme. Consider the staff call of the hospital when
choosing an operating mode. Choose the operating mode via the service
program.
turned off turned on turned off

static Operating Alarm
without
Off- Alarm
Alarm*) Operation
dynamic 1 sec
without Alarm
Off–Alarm
Operation
dynamic 1 sec 1 sec

with Alarm
Off-Alarm
Operation
*) in the mode static without Off-Alarm, the staff call can be surpressed with k
Caution: The user should always closely observe the local pump alarms as well.
Technical Data
Connecting Wire
white and green white and brown
Alarm disconnected connected
Operation connected disconnected
Polarity of connexion is arbitrary:

max. 24 V / 0.5 A / 12 VA
74
Chapter 11
PCA-ACCESSORIES
• Space PCA-Kit (REF 8713554) consisting of: :
- Demand button
- Hook and loop tape
for fixation of the demand button at
the patient s arm
- Line fixation
connection between hook and loop tape
and demand button
- Metal clip
alternatively for fixation at the bed
sheet
- Cable strap
for wrapping the cable of the demand
button
Fixation of the demand button:

at the wrist: or at the bed sheet:
Usage of the cable strap:
75
ORDERING
Art. No.
B. Braun Infusomat® Space (100 - 240 V) ...........................................871 3050
Recommended accessories for the B. Braun Infusomat® Space:

SpaceStation........................................................................................................871 3140
SpaceCover Standard............... .........................................................................871 3147
SpaceCover Comfort..........................................................................................871 3145
PoleClamp SP.......................................................................................................871 3130
Power Supply SP EU III......................................................................................871 3110D
Power Supply SP EU III 3.0m...........................................................................871 3123D
Power Supply SP GB III .....................................................................................871 3111D
Power Supply SP US III .....................................................................................871 3112D
Power Supply SP AU III .....................................................................................871 3113D
Power Supply SP-RSA plug .............................................................................871 3115D
Power Supply SP CN III ..... ..............................................................................871 3117D
Power Supply SP DK III.....................................................................................871 3118D
Power Supply SP BR III .....................................................................................871 3119D
Power Supply SP KR III .....................................................................................871 3120D
Combi Lead SP 12 V ..........................................................................................871 3133
Drop Sensor SP ..................................................................................................871 3175
Short Stand SP. ...................................................................................................871 3135
Battery-Pack SP (NiMH)...................................................................................871 3180
Battery-Pack SP (NiMH) incl. Pin .................................................................871 3180A
Battery-Pack SP (LiIon) incl. Pin and WiFi..................................................871 3182A
Interface Lead CAN SP......................................................................................871 3230
Interface Lead RS232 SP..................................................................................871 3234
Connection Lead SP (12 V)..............................................................................871 3231
Connection Lead for Staff Call SP ................................................................871 3232
Space PCA Kit......................................................................................................871 3554
Infusomat® Space Lines:

IV - Standard
Single packed………………………………………...........................................870 0036 SP
Secondary packaging (10x10).................................................................870 0435 SP
Single packed extra long (300cm) ........................................................827 0350 SP
Neutrapur......................................................................................................825 0731 SP
with Eurofix injection port por needle access...................................870 0087 SP
Neutrapur - with Safeflow needle free Y-port..................................870 0110 SP
Neutrapur - with Y-Port for needle access ........................................825 0383 SP
76
ORDERING
SafeSet IV - Standard:
Single packed .............................................................................................870 1148 SP
Single packed extra long (300cm) ........................................................827 0358 SP
Neutrapur......................................................................................................870 1149 SP
Neutrapur - with Safeflow needle free Y-port..................................870 0118 SP
UV light protected:
Amber - light protected, orange tubing..............................................870 0127 SP
SafeSet, amber - light protected, orange tubing .............................870 0128 SP
Amber - light protected, needle free Y-Port,
orange tubing ..............................................................................................825 0437 SP
SafeSet, amber - light protected, needle free Y-Port,
orange tubing ..............................................................................................825 0438 SP
Opaque - light protected, black tubing...............................................870 0125 SP
Transfusion:
with 200 µm blood filter .........................................................................827 0066 SP
with 200µm blood filter, needle free Y-port......................................827 0074 SP
Enteral Nutrition:
with 1000 ml Nutrifix bag, Y-port Luer Lock ....................................825 0839 SP
with 1000 ml Nutrifix bag, inverse Safety
Y-Port, EN Lock pat. connector ..............................................................825 0836 SP
Neutrapur - with multi bottle connector ...........................................825 0857 SP
Neutrapur - with multi bottle connector
inverse Safety Y-Port, EN Lock pat. connector..................................825 0856 SP
Neonate:
Dosifix® - 150 ml burette, Neutrapur® with
needle free Safeflow Y-Port ....................................................................825 0245 SP
Dosifix® - 150 ml burette, DEHP-Free
tubing with Y-Port for needle access...................................................825 0294 SP
77
ORDERING
Oncology
Neutrapur® - with inline 0.2 m Sterifix® Filter ............................... 870 0095 SP
SafeSet Neutrapur® - with inline 0.2 m Sterifix® Filter ............... 870 0098 SP
Piggyback
with needle free Safeflow injection port and integrated BCV ..... 825 0710 SP
SafeSet with needle free Safeflow injection
port and integrated BCV ..........................................................................825 0718 SP
secondary line with integrated BCV .....................................................406 2877
SafeSet secondary line with integrated BCV .....................................406 2878
78
Manufactured by
B. Braun Melsungen AG B. Braun Melsungen AG
34209 Melsungen Sparte Hospital Care
Germany 34209 Melsungen
Tel +49 (0) 56 61 71-0 Germany
Tel.: +49 (0) 56 61 71-0
38911794 • Drawing No. I0686700201 Fax: +49 (0) 56 61 71-20 44
Printed on pulp bleached 100 % chlorine-free
0715 www.bbraun.com

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Operating Manual Infusomat Space PDF

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Infusomat® Space

Instructions for Use

It is recommended that all pumps at

Infusomat® Space Overview ...................................................................................................3

Cover of Battery Compartment

Port for drop sensor

Port P2 for power supply, SpaceStation,

Pump based free flow Yellow Line guide Upstream

Pole clamp handle Fixaton of PoleClamp (Universal Clamp)

Mandatory action: see instruction for use.

See accompanying documents.

Type CF unit with defibrillation protection

Protection class II device

Symbol indicating separate collection for electrical and

CE mark compliant to Directive 93/42/EEC

Limitation of the atmospheric pressure

Non-ionizing electromagnetic radiation

General warning sign (e.g. Caution)

Safety instructions for using PCA

Safety instructions for using TCI

Safety Instructions for using Pole Clamp

1. Line pump up with the Pole Clamp

MENU STRUCTURE / NAVIGATION

At the top of the screen the last therapy is

Parameters which can be changed (e.g.

Typical display during infusion:

Mains Set pressure limit and

Unit of drug application

All status information is available in the

This hint pops up if a user tries to edit or

Set pressure level with l or r and con-

Pre-alarms are indicated by a message on

In case of an operating alarm (e.g. "VTBI

Press and hold o for 3 sec to turn pump

Start Up Main Special Options Status

Line Dose Rate Occlusion Intermediate

Use last Change-over Bolus Intermediate

Use dose rate Total

Status Date WLan

Insert the infusion line from right to

Next attach the white clip.

Insert the freeflow clamp (see red

may be prolonged. Also a wrong delivery rate is possible.

1.2 Entry With Different Combinations of Rate, VTBI

1.3 Bolus Application

1.4 Infusion Line Change and New Therapy Start

Push cover opening with pen.

Remove crank from inside of

Turn crank to remove emergency

Remove emergency aperture cover.

Turn crank inside aperture to open

1.5 End of Infusion

1.6 Standby Mode

2.2 Rate, VTBI and Time Change Without Infusion

Reset Status Menu Data:

3.2 Dose Rate Calculation (Operation)

a Enter the concentration by entering the amount of the active ingredient

3.3 Drug Library

3.4 Patient Controlled Analgesia (PCA)