Perfusore Space Manual

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

your ward are equipped with the
same software version.
GB Valid for software 688J
CONTENTS
Perfusor® Space Overview.......................................................................................................3

Symbols on Product ..................................................................................................................5
Patient Safety ........................................................................................................................6
Menu Structure / Navigation...............................................................................................10
Chapter 1 Operation .........................................................................................................12
1.1 Start of Infusion.........................................................................................................................12
1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused)
and Time .......................................................................................................................................13
1.3 Bolus Application.......................................................................................................................14
1.4 Syringe Change and New Therapy Start.............................................................................15
1.5 End of Infusion ...........................................................................................................................16
1.6 Standby Mode.............................................................................................................................16
Chapter 2 Advanced Operations....................................................................................17
2.1 Status Request of Pump when Infusion is Running........................................................17
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data ................................................................................................................17
Chapter 3 Special Functions* .........................................................................................18
3.1 Dosing Units and Dose Rate Calculation (Overview) ......................................................18
3.2 Dose Rate Calculation (Operation) .......................................................................................18
3.3 Drug Library.................................................................................................................................19
3.4 Patient Controlled Analgesia (PCA) ......................................................................................21
3.5 Target Controlled Infusion (TCI) ............................................................................................23
3.6 Barcoding .....................................................................................................................................29
3.7 Ramp and Taper Mode .............................................................................................................30
3.8 Program Mode ............................................................................................................................33
3.9 Intermittent Mode.....................................................................................................................35
3.10 Dose Over Time...........................................................................................................................37
Chapter 4 Options..............................................................................................................39
4.1 Occlusion Pressure.....................................................................................................................39
4.2 Data Lock......................................................................................................................................39
4.3 Bolus Rate....................................................................................................................................40
4.4 KVO-Mode....................................................................................................................................40
4.5 Contrast / Display Light / Keypad Light ..............................................................................41
4.6 Alarm Volume..............................................................................................................................41
4.7 Date / Time...................................................................................................................................41
4.8 Macro Mode ................................................................................................................................41
4.9 Language ......................................................................................................................................42
Chapter 5 Alarms ...............................................................................................................43
5.1 Device Alarm ...............................................................................................................................43
5.2 Pre-Alarms and Operating Alarms........................................................................................43
5.3 Reminder Alarms........................................................................................................................46
5.4 Alarm Hints..................................................................................................................................46
Chapter 6 Battery Operation and Maintenance .......................................................47
Chapter 7 Compatible Syringes .....................................................................................49
*The availability of Chapter 8 Start Up Graphs and Trumpet Curves......................................................52
the listed features
is depending on
Chapter 9 Technical Data ................................................................................................53
the configuration Chapter 10 Warranty / TSC** / Service / Training / Cleaning / Disposal..............55
of the pump.
**Technical Safety
Chapter 11 Instructions for Use Accessory ..................................................................57
Check. Ordering ......................................................................................................................61
2
PERFUSOR SPACE® OVERVIEW
P E R F U S O R ® 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 Drive head with
0-9, answer Yes/No questions. to zero and switch back to claws to hold the
Arrow left and -right the previous screen/menu syringe plunger
Select data from a scale and switch between digits when level. plate and
emergency re-
c
numbers are entered. Open a function while pump is
running or stopped with the left arrow key. lease button.
q Press to
initiate Press to turn
Yellow LED: Pre-alarm, reminder alarm
bolus. pump on/off.
Green / Red LED: Infusion occuring / device alarm,
B o
n
operating alarm
Blue LED: Currently connected to SpaceControl
k m
Open certain functions Press to link the pump to
f
S Syringe holder locks syringe
and press to confirm SpaceControl and to assign Press to Start/Stop in position. The drive will
values/settings/alarms. a barcode after scanning. infusion. automatically move back.
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.
Port P2 for power supply, SpaceStation,

Port P3 for future options
connection lead (12V), combi lead and
further accessory leads (staff call, service)
3
PERFUSOR® SPACE OVERVIEW
Syringe Fixation
Pull and turn the syringe holder to the right
to open the green axial fixation (see red
arrow). Syringe must be fixed with wings
upright in the slot (found to the left hand
side of the axial fixation) before closing
syringe holder. Make sure that syringe is
properly inserted.
Caution: Don't touch piston brake when
moving forward.
Fixaton of PoleClamp (Universal Clamp)

Line up bar of pump with bar of PoleClamp
and slide PoleClamp forward until locking
mechanism clicks.
To remove, press release button on frame,
push handle down and pull PoleClamp
backwards.
Transport
A maximum of three pumps (Perfusor®
Space or Infusomat® Space) plus one
SpaceControl may be stacked together (in
ambulance cars or 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.
Pole Fixation
Push the opening of 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!
4
SYMBOLS ON PRODUCT
SYMBOLS ON PRODUCT
Symbol Explanation
Caution, general warning symbol
W Caution, see documentation supplied
with the product
Type CF unit with defibrillation
protection
Protection class II device
Labeling of electric and electronic devices

according to directive 2002/96/EC (WEEE)
CE mark compliant to Directive 93/42/EEC
5
PATIENT SAFETY
PAT I E N T S A F E T Y
w
Intended use
The Perfusor® Space Infusion Syringe Pump System includes an external trans-
portable electronic infusion syringe pump and pump accessories. The system is
Read Instructions
intended for use on adults, pediatrics, and neonates for the intermittent or con-
for Use prior to use.
tinuous delivery of parenteral and enteral fluids through clinically accepted
The infusion device
should only be routes of administration. These routes include, but are not limited to intra-
used by specially venous, intra-arterial, subcutaneous, epidural, and enteral. The system is used
trained staff. for the delivery of medications indicated for infusion therapy including but not
limited to drugs like anesthetics, sedatives, analgesics, catecholamines, antico-
agulants etc.; blood and blood components; Total Parenteral Nutrition (TPN);
lipids, and enteral fluids. The Perfusor® Space Infusion Syringe 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
The medical specialist must decide on suitability for application on the basis of
the warranted properties and the technical data.
For further details please refer to the Instructions for Use.
Operation
• The initial training of the Perfusor® 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 of the
changes to the device and accessories by referring to the Instructions for Use.
• Ensure the unit is properly positioned and secured. Do not position pump
unit above patient.
• Prior to administration, visibly inspect the pump and the accessories
(especially the axial fixation) for damage, missing parts or contamination and
check audible and visible alarms during selftest.
6 6
PATIENT SAFETY
• Only connect to patient once the syringe has been inserted correctly and
there is proper fixation of the syringe pressure plate by the claws of the drive
head. Interrupt connection during syringe change to prevent incorrect dose
delivery.
• Select syringe/catheter suitable for use with the intended medical application.
• Position the infusion line free of kinks.
• Recommended change of disposable each 24 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.
• Do not operate the pump in the presence of flammable anaesthetics to
prevent explosion.
• Compare the displayed value with the entered value. Start infusion only if
the values are corresponding.
• If staff call is used we recommend checking the equipment once after
connecting the pump.
• Protect the device and the power supply against moisture.
• Do not carry the pump device by it's drive mechanism during transportation.
• If the pump device falls or is exposed to force it needs to be examined 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.
• A supplemental patient monitoring must be carried out if life-saving
medication is performed.
• Avoid applying external force on the drive mechanism during administration.
• 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 (e.g. body weight) are
changing always the flow rate will be updated and the dose rate will be fix.
7
PATIENT SAFETY
Other components
• Only use pressure resistant tubes (min. 2 bar/1500 mmHg).
• 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 the according 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.
• The use of incompatible disposables may influence the technical
specifications of the device.
• 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
Perfusor® 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/EN 60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment
is operated in the vicinity of other equipment which may cause high levels of
interference (e.g. HF surgical equipment, nuclear spin tomography units,
mobile telephones etc.) maintain the recommended protective distances from
these devices.
• The Perfusor® Space fulfils the applicable requirements of EN 13718 to be
used in the air, on the water and in difficult terrain. During transport the
Perfusor® 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 Perfusor® Space needs to
remain under room temperature at least one hour before usage.
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.
• For additional safety the removal of the syringe can be prevented by the use
of the Syringe Anti Removal Cap (see accessories) and the locking of the
syringe holder. The Syringe Anti Removal Cap is usable for the following
8
PATIENT SAFETY
syringes: B. Braun Original Perfusor Syringe 50 ml, B. Braun Omnifix 50 ml,

BD Plastipak 50/60 ml and Tyco Monoject 50 ml. The locking of the syringe
holder is under the pump and is locked by a clockwise turn of 90°. Make sure
the syringe holder is safely locked. Opening of the syringe holder may not be
possible after locking.
• In case opioids are administered and the Syringe Anti Removal Cap is not in
use and the syringe holder is not locked the therapy only should be
performed under surveillance of medical staff. This especially is necessary in
case non-authorised access to the drug can be anticipated.
• 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.
• It is possible to completely switch off the TCI mode to avoid the use of TCI
accidentally.
9
MENU STRUCTURE / NAVIGATION

Cutline
o On/Off button k OK button
f
s Start/Stop button q Keypad with arrow up, -down,
b
n Bolus button -left, -right button
c Clear 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 sf
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
10
Display Meaning
All status information is available in the

bottom line of the dislplay. The desired
information can be selected by using d
u and will be displayed permanently
thereafter (e. g. drug long name, time until
syringe empty etc.).
n has been pressed while the pump is

b
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

confirm by pressing k.
Cancel to edit pressure by using c.
Pre-alarms are indicated by the message

on the display (e.g. “Syringe nearly
empty”), an audible tone and a flashing
yellow LED. To confirm a pre-alarm
press k.
In case of an operating alarm (e.g.

"Syringe empty") the infusion stops, an
audible tone sounds and the red LED is
flashing. 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 a syringe inserted the
pump will not turn off but will use stand-
by.
11
OPERATION
Chapter 1
OPERATION
1.1 Start of Infusion
• Ensure correct installation of the pump device. If the pump is connected to mains,
the display states information such as the battery status, the mains connection
symbol and the last therapy.
• Press o to switch on unit. Note the automatic selfcheck: “Selftest active” and the
software version are displayed, two audible tones sound and all three LEDs (yellow,
green/red and blue) flash once. Information on power supply (battery or mains
connection), the set pressure level and the syringe (if syringe already inserted) are
displayed. Hence the drive moves backwards.
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 with direct entry of therapy parameters or open pump cover and
syringe holder to start with syringe insertion.
• Insert syringe with wings of the syringe upright in the slot to the right of the
housing. Close syringe holder and pump door. Piston brake moves forward.
Caution: Never leave the pump unattended during syringe loading.
• Confirm syringe type with k. Type of syringe indicated must coincide with syringe
inserted.
• Drive will advance and grip pressure plate of syringe.
Caution: Keep your hands away from advancing device.
Note: Make sure that the piston brake moves back into the syringe holder.
• If the prime function is activated, press U to prime infusion set at 1200 ml/h
(pressing key once = 1 ml). Interrupt prime function with k. Repeat procedure
until infusion line is fully primed. Then press d to proceed.
• Connect with patient.
• Respectively answer questions in Start Up Menu with u and d, until the rate is
displayed in the Main Menu.
Enter infusion rate:
• Press l and set rate using q.
12
OPERATION
Chapter 1
• Press s
f to commence infusion. Running arrows on display and green LED
above display indicate pump is infusing.
Note: Stop the infusion at any time by pressing s
f. 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 Perfusor® 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 tar-
get symbol, apparent in the Main Menu, shows the established parameter for the ap-
plication (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 Main Menu and the run display (values are counting down).
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 at the
Target: VTBI
3.) Infusion with time limit
Enter rate and time: The infusion volume will be calculated and displayed at the
Target: Time
Changing already entered values of VTBI and time (rate, VTBI and time already exist
at the point of change):
13
OPERATION
Chapter 1
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
Note: Changing VTBI/time is only possible while the pump has been stopped.
1.3 Bolus Application

There are three ways to administer a bolus:
1.) Manual Bolus: Press n b. Then press k and hold button. Fluid is
administered as long as button is held down. The infused bolus volume is
displayed.
The max. bolus volume is limited to 10 % of the syringe size or 10 sec.
Reaching this limit is indicated by an acoustic signal.
2.) Bolus with volume preselection: Press n b. Then press l and set bolus dose
limit by using q. Press n b. to confirm and start bolus. Depending on the
service tool settings an acoustic signal will sound after finishing the bolus
volume.
3.) Bolus with rate calculation: Press n
b. 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 n
b. to confirm and start bolus.
After pressing the button nb the bolus unit can be selected by using d. The
selected unit will be stored and offered as default later on. By this also in dose
mode it is possible to administer a bolus in ml.
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 n
b, 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 n
b.
Answer the following question by pressing u in order to start the purge
process. Cancel by pressing u 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.
14
OPERATION
Chapter 1
1.4 Syringe Change and New Therapy Start

Note: To avoid incorrect dosing, always disconnect the pump from the patient when
changing the syringe. Never leave the pump device unattended during syringe change.
Before inserting a new syringe check if the axial fixation is properly working.
• Press s
f to stop the infusion. The green LED will disappear.
Disconnect the pump from the patient.
• Open syringe holder. Drive mechanism moves backwards into starting position. If
the syringe holder is being opened more than 30 sec after the pump was stopped
the question if a syringe change should be performed must first be answered with
u before the drive moves backwards (regardless of the time this always applies in
case of a syringe holder alarm). If a syringe holder is pulled just shortly (less than
one second) the displayed question must first be answered by pressing u to
initiate the release of the syringe plunger.
• Open pump door, remove syringe and insert new syringe.
Note: In case the plunger head of the syringe is not released anymore by the claws
when performing a syringe change, the emergency release button needs to be pressed
to release the claws of the drive head. The emergency release button is placed on the
outside of the drive head. It can be released with a pointed pen. Then manually open
the claws and take out the syringe.
• Close the syringe holder (Note: Piston brake must move forward!) and the pump
door and confirm the inserted syringe type with k. Drive advances and grips
pressure plate of syringe.
Note: Do not block advancing drive unit with any objects. Piston brake must move
backwards into the syringe holder.
• Prime pump if necessary with u then press d to continue.
• Connect the patient to the pump and check set parameters using t.
• Press s
f to start infusion.
To start a new therapy after a syringe change:
• Press c when pump is in the Main Menu.
• Press d and continue to set new therapy parameters with q.
• Press s
f to start infusion.
Note: A new therapy can be started at any time during a stopped infusion. Press
c (repeatedly) when the pump is in the Main-, Status- or Options Menu and
proceed to follow instructions as described.
15
OPERATION
Chapter 1
1.5 End of Infusion

• Press s
f to stop the infusion. The green LED disappears. Disconnect the
pump from the patient.
• Open the syringe holder. Answer the question whether a syringe change should be
performed with u. The drive moves backwards into the starting position.
• Open pump cover. Remove the syringe, move the syringe holder into an upright
position and close the front door.
• Press o for 3 sec. to switch the pump off. The drive moves into parking
position.
Note: The settings will be permanently saved by the switched off device.
As long as a disposable is inserted the pump will use standby.
1.6 Standby Mode

In the case of extended interruption, the user has the option to maintain the set values.
• Press s
f to stop the infusion. Then press o for less than 3 sec.
• Confirm that the pump is supposed to switch into 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. Change of remaining time by pressing l.
Exit standby by pressing c .
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.
16
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 is 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 question if the last
therapy is to be used with u and reset the values with u.
The type of the inserted syringe is displayed in menu item „Syringe“ 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. 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".
17
SPECIAL FUNCTIONS
Chapter 3
SPECIAL FUNCTIONS
3.1 Dosing Units and Dose Rate Calculation (Overview)

The following table shows the dosing units of the gram and unit family and
their conversion used in the pump:
Gram family 106 ng 103 µg 1 mg 10-3 g

Unit family 103 mIU 1 IU 10-3 kIU 10-6 MIU
In addition to these dosing units the user can choose:
• Feeding: kcal, mEq, mmol
• kg
• Surface related amount units: m2
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.
Dose
Infusion rate [ml/h] =
Concentration [
x Patient weight (optional) ]
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 in kg or lbs or m2 or grams.
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.
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 weight shall not be entered press d.
Press t to choose “weight” or “surface” and confirm with k.
18
SPECIAL FUNCTIONS
Chapter 3
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 automatically
be 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 s
f.
Concentration and dose can later 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 resetted 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 Areas 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 Area
and creation date (see headline) should be checked in the pump.
Note: Barcode search is possible in Drug libraries with one Care Area and one
patient only.
There are different ways of embedding the drug library into the therapy. 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.
19
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 Area with l. If you
have already set the Care Area once on your pump this step will be skipped for
the next time.
• Change the Care Area by navigating through the list until "Change Care
Area" will be displayed. Press k to change the Care Area.
• 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.
• Check if the drug short name in the Main Menu is the same as the selected
drug. Check the parameter in the Main Menu with t and start infusion
with s
f.
Note: Care Area and Patient Profile can not be changed within a therapy.
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 s
f.
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 =
20
SPECIAL FUNCTIONS
Chapter 3
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.
3.4 Patient Controlled Analgesia (PCA)

For PCA a drug list with at least one drug activating the profile PCA is neces-
sary. 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.
21
OPTIONS
Chapter 3
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 set-
tings stored in the drug list are
displayed *.
The therapy can be started now with s
f 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 syringe 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.
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.
*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
two boli.
22
SPECIAL FUNCTIONS
Chapter 3
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).
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 con-
centration 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 measure-
ment 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.
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:
23
SPECIAL FUNCTIONS
Chapter 3
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 pharma-
codynamics 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 modi-
fied in such way is schematically depicted by the illustration on the next page.
24
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
25
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.
26
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
takes 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.
27
SPECIAL FUNCTIONS
Chapter 3
Confirm target with k. TCI can be started now with s

f.
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
Indicator) 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.
28
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 s

f.
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
- 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
Software version J has the barcoding functionality included but initially not activated.
Please contact your local sales representative in case you like to use
barcoding.
29
SPECIAL FUNCTIONS
Chapter 3
3.7 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 ist 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
characteristical 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.
30
SPECIAL FUNCTIONS
Chapter 3
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.
• Insert disposable and use the drug library according to the Instructions for
Use.
The pump now lits 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 s
f.
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 s
f.
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.
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SPECIAL FUNCTIONS
Chapter 3
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.
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 in-
fuse 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 pressing s f. Ramp and Taper is stopped immediately
without Taper phase and started without a new Ramp phase. This will not have
any effect on the settings of the therapy.
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.
32
SPECIAL FUNCTIONS
Chapter 3
3.8 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
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.
33
SPECIAL FUNCTIONS
Chapter 3
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.
• Adjust VTBI with q.
f.
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 s
f.
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 sf. This will not have any effect on the settings
of the therapy.
34
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 configerd paramters can
be checked by Program Parameter Menu in Main.
3.9 Intermittent Mode

The Intermittent Mode consists of 2 phases. This phases will be repeated.
• 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 auto-
matically 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.
35
SPECIAL FUNCTIONS
Chapter 3

• 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.
Note: Bolus rate is calculated by editable parameters. These parameters have to
be checked by the user before starting the infusion.
f.
Starting Intermittent Mode via Special Function Menu:

• Switch on pump with s f 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 s
f
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 s
f.
Note: The delivery of drugs can be stopped and started again in the Intermittent
Mode at any time by pressing sf. During infusion it is possible to change the
bolus volume, amount, VTBI as well as the time interval.
• Press C.
36
SPECIAL FUNCTIONS
Chapter 3
• 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.
• 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.
3.10 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. It can only be activated via the Drug List Manager. It can
be used for standard infusion.
The active Dose Over time function is always symbolised with a characteristical
symbol in the Display ( ).
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.
37
SPECIAL FUNCTIONS
Chapter 3
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
• 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 s
f.
38
SPECIAL FUNCTIONS
Chapter 3
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.
39
OPTIONS
Chapter 4
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.
4.1 Occlusion Pressure

The higher the pressure level is set at, the higher the pressure level must rise before
triggering an occlusion pressure alarm.
• 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.
4.2 Data Lock

The data lock function protects the device against unauthorized access. A four
digit code (default setting “9119”), which can be changed via the service
program activates this function in level 1 or level 2. 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 syringe, 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.
40
OPTIONS
Chapter 4
Event Level 1 Level 2 Level 3

Change of disposable ü û ü with code for
level 1/2
Start of infusion ü û ü
Change of parameters û û û
Stop of infusion ü ü % ü
Switching off pump / Standby ü û û %
PCA bolus with pump-based bolus button û û ü
Customisable screen û û ü
Acoustic feedback of demanded boli û û ü
Indicates denied PCA boli ü ü û
ü= possible | û = not possible | %= followed by standby-alarm
Activation of the function:
• Open data lock in Options Menu with l.
• 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
withy 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
activated 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.
4.3 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 1800 ml/h, e.g. 0,5 ml are reached within just one second.
4.4 KVO-Mode
After reaching a preselected VTBI/time, the pump can continue the infusion with a
predefined KVO-rate (see "Technical Data"). The duration of the KVO-infusion is set via
the service program.
41
OPTIONS
Chapter 4
• Open KVO-Mode in Options Menu with l.

• Answer Yes/No question with u, to activate KVO.
4.5 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. For use with light sensitive drugs the keypad- respectively syringe light
can be completely turned off.
4.6 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.
4.7 Date / Time

• Open date/time in Options Menu with l.
• Change date/time with q and confirm with k.
4.8 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.
42
OPTIONS
Chapter 4
4.9 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 with u.
43
ALARMS
Chapter 5
ALARMS
The Perfusor® 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 flashes 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.
The red LED goes off.
Pre- yes off flashes see alarm de- (de-)activate Press k to mute
Alarm scription via service alarm and turn off staff
program call. Visible alarm
remains until end.
Reminder yes off flashes see alarm de- yes Press k to mute
Alarm scription alarm, turn off staff
call and delete the
alarm text.
Alarm no off off see alarm de- no Hint disappears
Hint scription without confirmation.
5.1 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 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.
5.2 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 blinks 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 k. Display and LED stay in pre-
alarm until the operating alarm goes off. Pre-alarms don't lead to an interruption of
the infusion.
44
ALARMS
Chapter 5
Display message Pre-alarm reason

“Syringe nearly empty“ Very little fluid is left in syringe.
“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 active“ Volume/time are reached and the pump continues
the infusion at the KVO-rate.
“Communication error" The pump is located in a system in which at least
one device is incompatible or defective. The use
of this device in a system is not permitted. The
system is to be checked by a service technician.
A stopwatch on the display counts down the remaining time (depending on the
service program, between 3-30 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“ and the reason for the operating alarm. The signal tone and the staff
call are turned off with K. Corrections should be made in accordance with the
alarm reason.
Display message Alarm reason
“Syringe empty“ There is no fluid left in the syringe.
Due to varying syringe tolerances of syringes
from other manufacturers, some fluid may be
left inside the syringe.
Restarting the infusion leads to a complete depletion
of the syringe and shut-off via the pressure sensor.
Perform syringe change as described in 1.4.
“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.
“KVO finished” KVO is reached. Continue with old or set new therapy.
45
ALARMS
Chapter 5
“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 syringe is empty, kinks are in tubing and
tubing isn't damaged, IV patency and filter patency.
Increase occlusion pressure if necessary.
Due to varying syringe tolerances of syringes from
other manufacturers, a pressure alarm may occur
because of high syringe friction forces.
“Syringe not correctly inserted” The wings of the syringe are not properly inserted.
Insert syringe according to describtion in “Overview
Perfusor® Space“ as well as 1.1.
“Syringe holder“ The syringe holder was opened during a running
infusion. Close syringe holder.
“Battery cover removed“ The battery cover is not properly engaged on the
battery compartment.
When pushing on the battery cover listen for “click”.
“Drive blocked“ An external interference kept the drive unit from
advancing.
Basically prevent all external interferences.
Consider “Patient Safety“.
“Calibrate device“ Pump calibration data have changed (e.g. after an
update).
Recalibrate device via the service program.
“Claw malfunction“ The emergency release button was pressed and the
claws manually opened.
Take out syringe and contact technical service department.
“Plunger plate not prop. fixed“ The syringe plunger plate does not attach to the
plunger plate sensor on the pump.
Check system for negative pressure and eliminate
cause. Consider “Patient Safety“.
“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 describtion “Overview Perfusor® Space“.
“Data were reset” Therapy and pump settings could not be restored.
Enter therapy and pump settings anew.
"Therapy data were reset" Therapy data could not be restored.
Enter therapy anew.
46
ALARMS
Chapter 5
“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 or in order to turn the pump off.
The red LED doesn’t extinguish until the administration is started again respectively the
pump is turned off.
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 is
then to be checked by a service technician.
5.3 Reminder Alarms

Reminder alarms only occur in two cases:
1. A syringe is inserted, the pump doesn’t administrate, no value is being edited and
the device is not operated for two minutes.
An acoustic tone sounds, the yellow LED blinks 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
blinks and a staff call is activated.
Confirm alarm with K and continue to set therapy.
5.4 Alarm Hints

If inproper entries are made the display states corresponding hints (e.g. “Attention!
Rate is out of range”; “The parameter can not be modified”) and an audible tone so-
unds. These hints disappear after a few seconds and don't need to be confirmed.
47
BATTERY OPERATION AND MAINTENANCE
Chapter 6

The Perfusor® Space is equipped with the latest NiMH-battery. It has an operating
lifetime of 8 hours at 25 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 (> 0,5 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 Perfusor® Space.
Important information for battery self-check:

If the battery symbol is blinking during mains operation, the battery is either
discharged or has a reduced capacity. In this case, the pump should not be
disconnected from mains. If it is necessary to disconnect the pump from mains power
for urgent reasons, the user should check to ensure 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).
The optimal life time of a battery pack will only be reached if it's completely dischar-
ged 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 possible, only charge the battery if it has been completely discharged.
• If a battery, which is not completely discharged, is charged several times, its
capacity can be reduced. Its original capacity can be reached again if the battery
is completely discharged and then recharged.
• 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 original
capacity will only be reached after several cycles of charging and discharging.
• The battery operating time can only be realized if the pump operates
continuously with a fully charged battery at room temperature. The display of
the battery operating time on the pump is an approximate value based on the
current delivery rate. If the battery is aged it may differ from the actual
achievable operating time.
48
Chapter 6
Caution: Batteries may explode or leak if they are opened or incinerated. Consider
disposal directions!
Battery maintenance:
To accurately balance the battery capacity a cyclical battery maintenance is necessary.
The pump asks the user to perform a battery maintenance every 30 days. The battery
maintenance 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 stora-
ge 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 per-
form 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.
49
COMPATIBLE SYRINGES
Chapter 7
COMPATIBLE SYRINGES
The syringe types listed in the following tables can be used with the Perfusor® Space.
Please refer to the listed material number (Mat. No.1)) to ensure specific syringe brand
compatibility.
The Time to Occlusion2) alarm has been measured at 5 ml/h. The measured data are
typical values which may vary because of possible syringe tolerances.
B. Braun has no influence on the quality of disposables from other suppliers. Changes
in quality may have an impact on the technical data of the pumps. B. Braun is not
liable for such changes. In these cases please contact the respective supplier.
Manufacturer:
B. Braun
Syringe Type Omnifix Omnifix Omnifix Omnifix Omnifix
B. Braun 2 ml 5 ml 20 ml 30 ml 50 ml
Mat. No.1) 461 7029V 461 7053V 461 7207V 461 7304F 461 7509F
Time to Occl.2) typ. typ. typ. typ. typ.
P1 [mm:ss] 0:39 0:58 1:04 1:13 1:16
P9 [mm:ss] 1:05 1:32 3:26 6:07 13:46
Manufacturer: Manufacturer:
B. Braun B. Braun
Syringe Type OPS OPS Syringe Type Omnifix Omnifix
B. Braun 20 ml 50 ml B. Braun 3ml3) 10ml LL
Mat. No.1) 872 8615 872 8810F Mat. No.1) 4617022V 4617100V
Time to Occl.2) typ. typ. A/P 4617022V-03 A/P 4617100V-03
P1 [mm:ss] 1:08 1:34 US 4610303V-02 US 4617100V-02
P9 [mm:ss] 4:35 15:27 Time to Occl.2) typ. typ.
P1 [mm:ss] 0:25 0:53
P9 [mm:ss] 1:43 3:50
Manufacturer:
TYCO EU
Syringe Type Monoject Monoject Monoject Monoject Monoject Monoject
TYCO EU 3 ml 6 ml 12 ml 20 ml 35 ml 50/60 ml
Mat. No.1) 1100- 1100- 1100- 1100- 1100- 1100-
603495 606159 612173 620036 635430 650090
Time to Occl.2) typ. typ. typ. typ. typ. typ.
P1 [mm:ss] 0:51 0:56 1:04 1:19 1:32 2:23
P9 [mm:ss] 1:16 1:41 3:27 5:27 12:05 15:58
50
COMPATIBLE SYRINGES
Chapter 7
Manufacturer:
TYCO USA
Syringe Type Monoject Monoject Monoject Monoject Monoject Monoject
TYCO USA 3 ml 6 ml 12 ml 20 ml 35 ml 50/60 ml
Mat. No.1) 8881- 8881- 8881- 8881- 8881- 8881-
513934 516937 512878 520657 535762 560125
8881- 8881- 8881- 8881-
713005 716008 712023 760089
P1 [mm:ss] 0:41 0:50 1:07 1:13 1:27 1:35
P9 [mm:ss] 1:17 2:07 3:45 4:49 11:50 15:46
Manufacturer:
Becton
Dickinson
Syringe Type Plastipak Plastipak Plastipak Plastipak Plastipak Plastipak
B-D EU/USA 3 ml 5 ml 10 ml 20 ml 30 ml 50/60 ml
Mat. No.1) 309585 309603 309604 309661 309662 309663
300910 300911 300912 300913 300863 300865
300134 300869
300629
P1 [mm:ss] 0:53 0:55 1:15 2:05 2:14 2:53
P9 [mm:ss] 1:15 1:34 3:27 6:30 6:36 15:34
Manufacturer:
Becton
Dickinson
Syringe Type Plastipak BD BD BD BD BD
B-D EU/USA BD 30 ml Luer Lock Luer Lock Luer Lock Luer Lock Luer Lock
3 ml A/P3) 5 ml A/P3) 10 ml A/P3) 20 ml A/P3) 50 ml A/P3)
Mat. No.1) 301229 302113 302135 300149 300141 300144
Time to Occl.2)
P1 [mm:ss] 1:25 0:24 0:28 0:50 1:11 3:17
P9 [mm:ss] 8:50 1:04 1:22 2:36 5:03 16:36
51
COMPATIBLE SYRINGES
Chapter 7
Manufacturer:
TERUMO
Syringe Type 3 ml 5 ml 10 ml 20 ml 30 ml 50 ml 60 ml
TERUMO
EU/USA/JAP
Mat. No.1) 3SS*03L 3SS*05L 3SS*10L 3SS*20L 1SS*30LZ1 2BS-50LG 3SS*60L
1SS*05LZ1 1SS*10LZ1 SS*20ES
Time to Occl.2) typ. typ. typ. typ. typ. typ. typ.
P1 [mm:ss] 0:43 0:35 0:55 2:12 2:25 3:01 3:34
P9 [mm:ss] 1:17 1:16 4:48 7:53 8:18 16:55 17:03
Manufacturer:
Codan
Syringe Type Codan Codan Codan Codan Codan Codan
Codan 2 ml3) 5 ml3) 10 ml3) 20 ml3) 30/35 ml3) 50/60 ml3)
Mat. No.1) 62.2637 62.4717 62.6706 62.7704 62.9555 62.8426

Time to Occl.2)
P1 [mm:ss] 0:07 0:09 0:19 0:36 0:45 1:48
P9 [mm:ss] 0:58 1:18 2:23 4:14 4:22 11:41
Manufacturer:
Fresenius
Syringe Type Injectomat
Fresenius 50 ml
Mat. No.1) 9000701
Time to Occl.2) typ.
P1 [mm:ss] 4:37
P9 [mm:ss] 21:09
52
START UP GRAPHS AND TRUMPET CURVES
Chapter 8
START UP GRAPHS AND TRUMPET CURVES

Start Up Curves 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 (disposable syringe) used. Deviations from the technical data of the pump
cannot be excluded if syringes (disposables) other than those stated in the order
data are used.
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)
53
TECHNICAL DATA
Chapter 9
T E C H N I C A L D ATA
Type of unit Infusion Syringe 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 (drip 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 +5 … +40 °C
• Atmospheric pressure 500 … 1060 mbar
Storage conditions:
• Relative humidity 30 % … 90 % (without condensation)
• Temperature -20 … +55 °C
• Atmospheric pressure 500 … 1060 mbar
Type of battery pack (rechargeable) NiMH
Operating time of rechargeable battery Approx. 8 hours at 25 ml/h
Recharging time Approx. 6 hours
Weight Approx. 1.4 kg
Dimensions (W x H x D) 249 x 68 x 152 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 ± 2 % according to IEC/EN 60601-2-24
Occlusion alarm pressure 9 levels up to 1.2 bar
Alarm in the case of incorrect dose For incorrect dosages of 0.1 ml due to
malfunctions of the device the pump will
automatically shut off.
Technical inspection (safety check) Every 2 years
54
TECHNICAL DATA
Chapter 9
Selectable delivery rates Continuous infusion rate range / bolus

rates in dependence on syringe sizes:
Syringe sizes Cont. rates* Bolus rates

[ml] [ml/h] [ml/h]
50/60 0.01 - 200 1 - 1800
optional
0.01 - 999.9
30/35 0.01 -100 1 - 1200
20 0.01 -100 1 - 800
10/12 0.01 -50 1- 500
5/6 0.01 -50 1 - 300
2/3 0.01 -25 1 - 150
Rate increments 0.01* - 99.99 ml/h in increments of

0.01 ml/h
100.0 - 999.9 ml/h in increments of
0.1 ml/h
Accuracy of bolus infusion typ. ± 2 %
Max. bolus after bolus reduction £ 0.2 ml
KVO-rate rate ³ 10 ml/h: KVO-rate 3 ml/h
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.
History protocol 1000 last history entries.
100 events for system diagnose.
Refer to separate documents of the
History Viewer for closer information.
*as default, infusion rates starting from 0.1 ml/h

can be set
55
WARRANTY / TSC* / SERVICE / TRAINING / CLEANING / DISPOSAL
Chapter 10
WARRANTY / TSC* / SERVICE / TRAINING /

CLEANING / 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 Perfusor® 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 material defects. Modifications or repairs to the unit undertaken by the
Devices user/operator or by third parties invalidate the warranty.
93/42/EEC” dated
14th June 1993.
The warranty does not cover the following:
Elimination of faults attributable to incorrect/unauthorized handling, or to
B. Braun normal wear and tear.
Melsungen AG Defective rechargeable battery packs can be returned to B. Braun for further
disposal.
Separate collection for electrical and electronic equipment

(currently applicable to EU community only).
Training
B. Braun offers a training for version J. Please ask your local representative for
further details.
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
B. Braun trained personnel.
56
WARRANTY / TSC* / SERVICE / TRAINING / CLEANING / DISPOSAL
Chapter 10
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.
Cleaning
Clean external surface of pump using mild soap suds. Do not use spray
disinfectants at the mains power connection. Recommended: disinfectant for
wiping available from B. Braun: Meliseptol® Foam pure, Melsitt 10% and
Melsept SF 10%. After cleaning, allow the device to vent for at least 1 min prior
to use. Do not spray into openings in the device. Be sure to observe the instruc-
tions provided concerning waste
disposal and hygiene for batteries and disposables. Wipe magnifying- and dis-
playglas on front of pump door only with a soft cloth. Do not use Hexaquart® or
other alkylamine containing disinfectants.
Disposal
The pumps as well as battery packs can be returned to B. Braun for further dis-
posal. 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.
This is even ruled by law in several countries. A respective form can be obtained
from B. Braun.
Included in Delivery
Perfusor® Space, Battery-Pack SP, Instructions for Use-Set.
57
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 Perfusor® Space"
and "Patient Safety".
Power Supply SP (8713110A - 8713114A)

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.
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.
58
Chapter 11
Note: A maximum of three plugs can be stacked upon each other in socket P2.
Battery-Pack SP (NiMH) (8713180)

Battery-Pack SP (NiMH) incl. Pin (8713180A)
For further information on the Battery-Pack SP (NiMH) see “Battery Operation”.
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).
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.
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!
59
Chapter 11
Connection Lead for Staff Call SP (8713232)

To connect the Perfusor® 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 Perfusor® 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
60
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
- PCA-Key
for locking the syringe holder or the Syringe Anti Removal Cap
• Syringe Anti Removal Cap PSP (REF 8713556)
Fixation of the demand button:

at the wrist: or at the bed sheet:
Usage of the cable strap:
Usage of the Syringe Anti Removal

Cap PSP:
The Syringe Anti Removal Cap PSP is
slided over the drive head from the
front and is fixed with the PCA-key
(270° clockwise rotation). Mind the
markings – make sure it is securely locked. Dismantling: counter clockwise
rotation of 270°. Push to the left and disengage.
Caution: When Syringe Anti Removal Cap is used always change the syringe as
soon the „syringe empty“ alarm appears.
61
ORDERING
Art. No.
B. Braun Perfusor® Space (100 – 240 V) ...................................................871 3030
Recommended accessories for the B. Braun Perfusor® Space:

SpaceStation ..........................................................................................................871 3140
SpaceCover Standard ..........................................................................................871 3147
SpaceCover Comfort ............................................................................................871 3145
PoleClamp SP ..........................................................................................................871 3130
Power Supply SP (Euro Plug)..............................................................................871 3110A
Power Supply SP (UK Plug) .................................................................................871 3111A
Power Supply SP (US Plug) .................................................................................871 3112A
Power Supply SP (Australian Plug) ...................................................................871 3113A
Power Supply SP (RSA Plug)...............................................................................871 3115A
Combi Lead SP 12 V..............................................................................................871 3133
Battery-Pack SP (NiMH).......................................................................................871 3180
Battery-Pack SP (NiMH) incl. Pin .................. ..................................................871 3180A
Interface Lead CAN SP .........................................................................................871 3230
Connection Lead SP (12 V) .................................................................................871 3231
Connection Lead for Staff Call SP ....................................................................871 3232
Space PCA Kit .........................................................................................................871 2554
Syringe Anti Removal Cap PSP..........................................................................871 3556
Original Perfusor® Syringes:

Original Perfusor® Syringe 50 ml without needle .......................................872 8844F
Original Perfusor® Syringe 50 ml with aspiration needle .........................872 8810F
Original Perfusor® Syringe 50 ml with aspiration needle
and particle filter .................................................................................................872 8852F
Original Perfusor® Syringe 50 ml black with aspiration needle
and particle filter...................................................................................................872 8828F
Original Perfusor® Syringe 20 ml without needle .......................................872 8615
Original Perfusor® Syringe 20 ml with aspiration needle .........................872 8623
Omnifix® 50/60 ml Luer Lock ...........................................................................461 7509F
Omnifix® 30 ml Luer Lock...................................................................................461 7304F
Omnifix® 20 ml Luer Lock...................................................................................461 7207V
Omnifix® 10 ml Luer Lock ...................................................................................461 7100V
Omnifix® 5 ml Luer Lock .....................................................................................461 7053V
62
ORDERING
Original Perfusor® Lines:

Original Perfusor® Line, made of PVC; 50 cm...............................................825 5172
Original Perfusor® Line, made of PVC; 150 cm ............................................872 2960
Original Perfusor® Line, made of PE; 50 cm..................................................825 5059
Original Perfusor® Line, made of PE; 100 cm ...............................................825 5067
Original Perfusor® Line, type Safesite, made of PVC,
with Safesite safety connector; 150 cm.........................................................872 2820
Original Perfusor® Line, type Filter, made of PVC,
with injection filter 0.22 µm; 200 cm.............................................................872 3001
Original Perfusor® Line, type PCA, made of PVC
with back check valve; 168 cm.........................................................................872 6019
Original Perfusor® Line, type MR, made of PVC,
with swivel nut; 75 cm........................................................................................872 2870
Original Perfusor® Line, type MR, made of PVC,
with swivel nut; 150 cm .....................................................................................825 5504
Original Perfusor® Line, made of PE, black; 150 cm...................................872 3010
63
Manufactured by: B. Braun Melsungen AG
B. Braun Melsungen AG Sparte Hospital Care
34209 Melsungen 34209 Melsungen
Germany Germany
Tel +49 (0) 56 61 71-0 Tel.: +49 (0) 56 61 71-0
38916517 • Drawing No. M688 70 02 01 F04 Fax: +49 (0) 56 61 71-20 44
Printed on pulp bleached 100 % chlorine-free
1210 • Date of last revision: November 2010 www.bbraun.com

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Perfusor® Space

Instructions for Use

It is recommended that all pumps at

Perfusor® Space Overview.......................................................................................................3

Cover of Battery Compartment

Port P2 for power supply, SpaceStation,

Fixaton of PoleClamp (Universal Clamp)

Protection class II device

Labeling of electric and electronic devices

CE mark compliant to Directive 93/42/EEC

Safety Instructions for using PCA

syringes: B. Braun Original Perfusor Syringe 50 ml, B. Braun Omnifix 50 ml,

Safety instructions for using TCI

MENU STRUCTURE / NAVIGATION

c Clear button m Connection button

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

All status information is available in the

n has been pressed while the pump is

This hint pops up if a user tries to edit or

Set pressure level with l or r and

Pre-alarms are indicated by the message

In case of an operating alarm (e.g.

Press and hold o for 3 sec to turn pump

1.2 Entry With Different Combinations of Rate, VTBI

a) Target symbol is placed in front of VTBI:

1.3 Bolus Application

1.4 Syringe Change and New Therapy Start

1.5 End of Infusion

1.6 Standby Mode

2.2 Rate, VTBI and Time Change Without Infusion

Reset Status Menu Data:

3.1 Dosing Units and Dose Rate Calculation (Overview)

Gram family 106 ng 103 µg 1 mg 10-3 g

3.2 Dose Rate Calculation (Operation)

a Set the patient weight with q and confirm with k.

3.3 Drug Library

The infusion is within the range of the maximum soft limit =

3.4 Patient Controlled Analgesia (PCA)

The A/D-ratio indicates the

An acoustic confirmation of demanded boli can be activated and modulated by

Hint: It is possible to start a therapy in continuous mode and switch over to

3.5 Target Controlled Infusion (TCI)

B. Braun Space is offering two modes for TCI:

Drug / Parameter Propofol Remifentanil

Setting up the pump

In this example: Propofol.

As a next step select the correct

Input of patient data

Use q for editing the patient data.

Editing a target and starting TCI

Editing this parameter is guided by

Confirm target with k. TCI can be started now with s

After TCI is started the screen looks the following:

Current plasma an effect-site concentration Target and unit

Useful information while pump is running

Pressing r a second time is offering

It is recommended to simply stop the pump by pressing s