Braun Infusomat Space Instructions For Use Manual

Infusomat® Space
and Accessories
Rx only
Instructions for Use
It is recommended that all pumps at
your institution are equipped with
the same software version.
US
Valid for software 586U
CONTENTS
Infusomat® Space Overview ...................................................................................................3
Symbols on Product...................................................................................................................9
Patient Safety ......................................................................................................................11
Menu Structure / Navigation...............................................................................................13
Entering values ......................................................................................................................15
Chapter 1 Operation..........................................................................................................18
1.1 Inserting and Priming line in Pump......................................................................................18
1.2 Drug Library..................................................................................................................................20
1.3 Programming a PRIMary Infusion in the Drug Library ...................................................25
1.4 Programming a SECondary Infusion in the Drug Library ...............................................28
1.5 Programming an Intermittent Dose Over Time Infusion ................................................32
1.6 Programming a Loading Dose in the Drug Library...........................................................33
1.7 Programming a Bolus with Dose and Time in the Drug Library ..................................35
1.8 Manual Bolus...............................................................................................................................36
1.9 Changing Care Unit ...................................................................................................................37
1.10 Changing display while pump is running ...........................................................................38
1.11 Basic Infusion (programming the pump outside of the drug library) ........................38
1.12 IV Line Change and New Therapy Start...............................................................................40
1.13 End of Infusion............................................................................................................................41
1.14 Standby Mode .............................................................................................................................42
Chapter 2
Pump Menus....................................................................................................43
2.1 Infusion Totals.............................................................................................................................43
2.2 Options ..........................................................................................................................................44
2.2.1 Downstream Occlusion Pressure...............................................................................44
2.2.2 Upstream Pressure ........................................................................................................44
2.2.3 Alarm Volume .................................................................................................................44
2.2.4 Dose Rate Calculator....................................................................................................44
2.2.5 Data Lock .........................................................................................................................48
2.2.6 KVO Mode........................................................................................................................48
2.2.7 Contrast / Display Light / Keypad Light..................................................................48
2.2.8 Bolus Rate........................................................................................................................49
2.2.9 Date / Time......................................................................................................................49
2.2.10 Macro mode ....................................................................................................................49
2.3.11 Wireless Activation .......................................................................................................49
2.3 Status Menu.................................................................................................................................49
Chapter 3
Alarms................................................................................................................51
3.1
3.2
3.3
3.4
Chapter 4
Chapter 5
Chapter 6
*The availability of
the listed features
depends on the
configuration of
the pump's
biomed file.
**Technical Safety
Check.
Wireless Drug Library Upload.....................................................................55
AutoProgramming and Barcoding.............................................................58
Battery Operation and Maintenance........................................................61
6.1
6.2
6.3
6.4
Chapter 7
Chapter 8
Chapter 9
Chapter 10
Ordering
Device Alarms ..............................................................................................................................51
Pre-Alarms and Operating Alarms.........................................................................................51
Reminder Alarms ........................................................................................................................53
Alarm Prompts.............................................................................................................................54
General...........................................................................................................................................61
Safety Instructions.....................................................................................................................62
Battery with WiFi .......................................................................................................................62
Battery maintenance.................................................................................................................63
Start Up Graphs and Trumpet Curves ......................................................66
Technical Data.................................................................................................67
Warranty / Training / TSC** / Service / Disinfection / Disposal ......76
Optional Space Accessories.........................................................................80
......................................................................................................................84
2
INFUSOMAT SPACE® OVERVIEW
I N F U S O M AT ® S PA C E O V E R V I E W
Follow on screen prompts using arrow keys to navigate
menus, select parameters, change values and respond to
on screen prompts.
q
Press to clear values in
programming screens or to
go back one screen.
c
Yellow LED: Pre-alarm, reminder alarm
Press to
initiate
bolus.
Green or Red LED:
or
Green LED:
Infusing
Red LED:
Operating or Device Alarm
Blue LED:
Press to select and/or confirm
values/settings/alarms/messages.
x
B
n o
Initiating connection to wireless
battery or SpaceStation
k
Press to turn
pump on/off
and initiate
stand by
mode.
Press to
open the
pump door.
f
S
m
Press to initiate auto-programming
orders when prompted.
Press to Start/Stop
infusion.
Cover of Battery Compartment
Before changing the battery, always disconnect the pump from the patient and switch the device off.
To remove the battery cover, push the button below the battery compartment with the point of a pen and pull the
cover away from the device. Slide the green locking mechanism on the back of the battery up and take out the battery
pack for repalcement.
A crank key used to open the pump door, which is stuck closed, is attached to the inside of the battery compartment
cover (for more information see subchapter 1.12).
Port P3 for future options
3
Port P2 for power supply, SpaceStation, combi lead
and additional accessory leads (staff call, service plug)
INFUSOMAT® SPACE OVERVIEW
Anti-free flow clip
(set based free
flow protection)
Opening
lever
Downstream
pressure sensor
Pump based free flow
prevention safety clamp
Air
sensor
Line Loading
Guide
Yellow
caution light
Line guide
cover
Upstream
pressure sensor
Pole Clamp SP (model 8713130)
Rotation lever
Pole clamp
release button
4
Attaching Pole Clamp to IV Pole
Position the opening of the Pole Clamp on
pole and turn the grey locking knob clockwise until pole clamp is secured to IV pole.
Turn grey knob counter clockwise to release.
For vertical positioning of Pole Clamp push
rotation lever down and rotate pump
either way until lever clicks into notch.
Push lever for rotation.
Caution: Do not lean on pump
when attached to pole!
Caution: A maximum of three B. Braun
Space pumps can be stacked together
when used with the PoleClamp SP.
INFUSOMAT® SPACE OVERVIEW
Attaching Pump to Pole Clamp
Line up slots on top sides of pump with
grooves of Pole Clamp and slide pump into
Pole Clamp until locking mechanism clicks.
To remove, simultaneously press release
button on frame and push handle down
while pulling pump out from pole clamp.
Pole clamp
handle
Pole clamp
release button
Pump slots
Locking Devices Together
A maximum of three pumps (Infusomat®
Space or Perfusor® Space) may be
inter-locked on a single pole clamp.
Caution: Avoid external mechanical
action.
Line up the grooves of the lower pump with
the slots of the upper pump and slide the
lower pump in until the lock clicks and the
green buttons are aligned with each other.
To disconnect, push green locking button of
upper pump and slide lower pump out.
The pump is now securely attached to Pole
Clamp.
• Do not position the pump unit over the
patient.
Underside view
Clamp grids
• DO NOT use any Pole Clamp that shows
signs of damage.
• DO NOT use Pole Clamp with missing
clamp grids.
5
INFUSOMAT® SPACE OVERVIEW
Space Pole Clamp (speed clamp)
(model 8713131)
Attaching Pole Clamp to IV Pole
Position the opening of the Pole Clamp
on pole and turn black knob clockwise
until pole clamp is secured to IV pole.
Turn black knob counter clockwise to
release from IV pole.
Attaching Pump to Pole Clamp
Line up slots on top sides of pump with
grooves of Pole Clamp and slide pump
into Pole Clamp until locking mechanism clicks.
The pump is now securely attached to the
pole clamp.
• Do not position the pump unit over
the patient.
6
INFUSOMAT® SPACE OVERVIEW
Locking Devices Together
Line up the grooves of the lower pump
with the slots of the upper pump and
slide the lower pump until the lock
clicks and the green buttons are aligned
with each other. To disconnect, push
green locking button of the upper pump
and slide lower pump out.
A maximum of three pumps (Infusomat®
Space or Perfusor® Space) may be interlocked on a single pole clamp.
Caution: Avoid external mechanical action.
Removing Pump from Pole Clamp
Pull both end tabs simultaneously to
gently eject/release the pump from pole
clamp. Slide pump out by hand to
remove fully from pole clamp.
➀
➁
Vertical Positioning
Simply turn the pump either way until it
clicks into notch at 90 degree/vertical
position.
➂
7
INFUSOMAT® SPACE OVERVIEW
Caution: Do not lean on pump
when attached to pole!
Caution: A maximum of three B. Braun
Space pumps can be stacked together
when used with the Space Pole Clamp
(speed clamp).
Power supply holder
The Space Pole Clamp (speed clamp) can
hold up to 2 Space Power Supplies
(8713112D) on the rear of the pole
clamp.
DO NOT use any Pole Clamp that shows signs of damage.
8
SYMBOLS ON PRODUCT
SYMBOLS ON PRODUCT
Symbol
Explanation
Mandatory action: see instruction for use.
See accompanying documents.
Type CF unit with defibrillation protection
Protection class II device
Symbol indicating separate collection for electrical and
electronic equipment (2002/96/EC) only for valid for Europe,
not applicable for US
CE mark compliant to Directive 93/42/EEC
Temperature Limit
Moisture Limit
Limitation of the atmospheric pressure
Non-ionizing electromagnetic radiation
General warning sign (e.g. Caution)
Unsafe symbol (Do not use in MRI environment!)
LOT
Batch number
SN
Serial number
9
SYMBOLS ON PRODUCT
List of abbreviations
KVO = Keep Vein Open
LED = Light-Emitting Diode
(indicator lamps)
TPN = Total Parenteral Nutrition
10
VTBI = Volume To Be Infused
MRI = Magnetic Resonance Imaging
BSA = Body Surface Area
PATIENT SAFETY
PAT I E N T S A F E T Y
Indications for Use
Read Instructions
for Use prior to
operation. The
infusion device
should only be
used by trained
healthcare
professionals.
The Infusomat® Space Volumetric Infusion Pump System is intended for use on
adults, pediatrics, and neonates for the intermittent or continuous delivery of
parenteral fluids, medications, blood and blood products through clinically
accepted routes of administration. These routes include intravenous, intraarterial, subcutaneous, and epidural.
Infusomat® Space Volumetric Infusion Pump System is intended to be used by
trained healthcare professionals in healthcare facilities.
Dedicated Disposables
The Infusomat Space is intended to be used with only dedicated disposables
labeled for the different routes of administration.
Warnings and Cautions
• The initial training of the Infusomat® Space is to be performed by B. Braun
sales and/or clinical personnel or other authorized persons. After each software update, the user must refer to the Instructions for Use to review
changes to the device and software.
Caution: Ensure the unit is properly positioned and secured (see ch.
Infusomat® Space Overview). Do not position pump above patient or in
a position where a patient could be harmed , should the pump fall.
• Prior to administration, visibly inspect the pump for damage, missing
parts or contamination and check audible and visible alarms during
selftest.
• Only connect to patient once the line has been correctly inserted and
completely primed (chapter 1.1). Disconnect from patient during line change
to prevent unintended delivery.
Caution: Insure the infusion line is free of kinks.
Caution: Do not operate in the presence of flammable anesthetics or in
a hyperbaric oxygen chamber.
• Not be used adjacent and stacked with other equipment except B. Braun
Space devices.
Caution: The Infusomat Space System is unsafe to use in proximity to
magnetic resonance imaging (MRI) equipment.
• Compare the displayed value with the entered value prior to starting
infusion.
11
PATIENT SAFETY
• Compare physician order to programming parameters including drug name,
patient profile and dosing prior to starting infusion.
• Check default values pre-populated from drug library with physician order
prior to starting infusion.
• Consider additional monitoring which may be required when infusing high
risk medications.
• Consider plausibility of calculated flow rate for infusions programmed with
BSA to assist in determining accuracy of patient height and weight values.
• If staff call is used, it is recommended to check the equipment once after
connecting the pump to insure staff call is working.
• If the pump is dropped or is exposed to force, it must be checked by the
service department.
• The default values and limits of the Drug Library provide a safety net and are
not intended to be used to define treatment.
• Changes in position of pump height in relation to patient during infusion
may lead to minor changes in flow accuracy.
• Do not allow liquids to enter into or come into contact with any openings or
electrical connections on the pump or power supply. Fluid exposure in these
areas may result in the risk of short circuit, corrosion or breakdown of
sensitive electrical components, and/or electrical shock. If fluid exposure
occurs, the device should be swapped out with another device in a manner
that presents minimal interruption to patient care. The device should remain
unplugged until it can be inspected by a trained technician for any evidence
of damage and/or residual moisture which may impair the function of the
device.
Safety Standards
Infusomat® Space satisfies all safety standards for medical electrical devices in
compliance with IEC 60601-1:2005 and IEC 60601-2-24: 2012.
• The EMC-limits (electro-magnetic compatibility) according to IEC 60601-12:2007 and IEC 60601-2-24: 2012 are maintained. If the equipment is
operated in the vicinity of other equipment which may cause high levels of
interference (e.g. HF surgical equipment, nuclear spin tomography units,
mobile telephones etc.) may be disturbed. Maintain the protective distances
recommended by the manufacturers of these devices.
• During transport of patients within the facility the Infusomat® Space needs
to be fixed on a suitable restraint system by means of SpaceStation,
Pole Clamp SP or Space Pole Clamp (speed clamp).
• When stored under temperature conditions beyond the defined operating
conditions the Infusomat® Space needs to remain under room temperature at
least one hour before usage.
12
MENU STRUCTURE / NAVIGATION
MENU STRUCTURE / NAVIGATION
Overview of Keys and Displays
o
x
f
s
b
n
On/Off key
Door open key
Start/Stop key
Bolus key
C
K
Q
m
Clear and/or back key
OK key
Keypad with arrows
Initiation of Auto-programming
order
All display screen shots are examples and may be different depending on pump
configuration and infusion settings.
Display
Meaning
At the top of the screen the last infusion
is indicated. "Continue last infusion"
question can be answered with Yes/No
question by pressing u for yes or d
for no. Pressing yes recalls all parameters
of the last infusion prior to power off,
both the last primary and secondary
therapies are retained.
Parameters can be changed (e.g. rate in
ml/h) by opening the editor screen
with with l or k. When editing
parameters, use the l or r to
move to the digit to be programmed.
The white background indicates current
digit. Use u or d to change current
setting or C key to clear the values.
Text on the bottom or top of the
screen indicates infusion mode, soft
limit symbol.
Typical display during infusion:
Wireless Current
Set pressure limit
pressure level
Infusion
mode
Connected to Power/Battery Status
Scrolling arrows indicate pump is infusing
Set rate can be opened with l to edit
Soft limit indicator
Drug name
Unit of drug delivery
Infusion status information
13
MENU STRUCTURE / NAVIGATION
Display
Meaning
All status information is available in the
bottom line of the display. The desired
information can be selected by using d
u and will be displayed (e. g. care area,
drug long name, time/ VTBI remaining
drug concentration, total volume, infused
totals for PRIMary and SECondary) until
changed by user.
This prompt appears 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 a message on
the display (e.g. “VTBI near end”), an
audible tone and a flashing yellow LED.
To confirm a pre-alarm press k.
Operating alarms stop the infusion, an
audible tone sounds and the red LED
flashes. Confirm alarm by pressing k.
Confirming does not provide 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.
The IV line must be removed to power the
pump off. Pump will go into stand-by if
the IV line is not removed.
14
ENTERING VALUES
ENTERING VALUES
For an infusion parameter to be entered and/or edited, the pump displays the name of
the value being edited (rate, doserate, etc), format and unit of measure (dosing unit,
volume, time, etc).
In the screen below, a Doserate value is to be entered, which in this case is specified as
mcg/kg/h. The underbars indicate the places which can be entered both to the left
and right side of the decimal point.
The value to be entered must be selected by using the arrow buttons to move the
cursor so the desired numerical value to be changed is highlighted. Use the Left and
Right arrows buttons to move the cursor and the Up and Down arrows keys to increase
or decrease the number.
Entering a new value:
For example, a value of 9.5 can be entered
by pressing the Up arrow button u in the
“ones” place 9 times and then press the
Right arrow button r once to move the
cursor to the “tenths” decimal place and
pressing the Up arrow button u 5 times.
Press the OK button k to confirm the
value, as indicated in the title bar of the
display.
Titrate an existing value:
Select the value to be changed by using the right r and left arrow l keys to highlight desired number, in this case the “ones” place.
To Titrate to another value, e.g. 11.5 press
the Down arrow button d eight times to
get 1.5
Then press the Left arrow button l to
move the cursor to the “tens” place and
press the Up arrow button u once .
15
ENTERING VALUES
Arithmetic logic:
An alternative method for entering and titrating values uses arithmetic logic:
Pressing the Up arrow u one time in the
“ones” place increases the value to 10.5
Pressing the Down arrow button d from
the “ones” place decreases the value to
9.5
Pressing the Up arrow button u from the
“ones” place 2 times increases the value to
11.5
Hard Limits:
The editor function keeps the displayed values between the minimum and maximum
hard limits for the selected infusion parameter. This can be either general pump limits
or drug specific limits defined in the drug library. In case an increase of a value would
exceed a hard limit, the pump displays the highest acceptable value presuming the
user wanted a maximum value.
Example: Assume the selected drug has a hard limit set at 15 mcg/kg/h.
Trying to titrate from 9.5 to 19.5. Press the Left button l to move the cursor to the
“tens” place.
Press the Up button u in order to increment to 19.5. As 19.5 is above the limit,
the value displayed is 15, as the hard limit
is the highest acceptable value.
16
ENTERING VALUES
IMPORTANT: If a value increase or decrease is not possible due to a hard limit (as 19.5
could be expected in this case), the value of the hard limit is displayed as the highest
acceptable value.
If the down arrow d is pressed on the above screen, the pump displays the previous
value i.e. 9.5.
If the up arrow u is pressed on the
above screen, the pump displays a clear
message that the value entered exceeds
the hard limit.
After the user confirms the message by
pressing the OK button k, the pump prefills the programming editor field with the
last value programmed and confirmed
prior to the value that created the alert.
While in the editor function the arrow
buttons Q and the OK button k are
used to define and confirm a value, the C
(clear) button c can be used to reset the
value to 0.
To exit the editor function, press the C button c again. The value of the infusion parameter
reverts to the last confirmed value.
17
OPERATION
Chapter 1
OPERATION
1.1 Inserting IV Line and Priming in Pump
• Ensure that the pump is properly installed (see Infusomat Space Overview above).
Check the equipment for completeness and damages.
• Spike infusion bag and fill drip chamber to 2/3 full.
• Press o to power on. The message “Self-test active” and the software version are
displayed, two audible tones sound and all three LEDs (yellow, green/red and blue)
flash once. The power supply indicator and the set pressure level are
displayed followed by the set limit for the accumulated air volume and the max.
size of air bubbles.
• Observe B. Braun landing page and press k to enter infusion parameters followed
by IV line insertion, or press x and then press u to open the pump door and
insert the line.
Note: Observe message indicating the roller clamp should be closed during set change.
Caution: Close the roller clamp before inserting the IV line and do not
connect to patient until properly loaded and primed.
Insert the IV line from right to
the left starting with the 2 hole
clip.
18
OPERATION
Chapter 1
Next attach the white clip.
Insure silicone segment is not
stretched or twisted, stars on tubing
must be in straight line and line
loading guide should not be twisted.
Anti-Free
Flow
clip insertion
Safety
clamp
Door hook
Insert the green anti-freeflow clip in
the green slot, in the direction indicated by the arrow, until the opening
lever snaps out, yellow light goes out
and pump based free flow protection
safety clamp occludes the lines.
Air sensor
guide
• Firmly press tubing into the air sensor guide to make sure the line is properly
inserted into the sensors. Thread the tubing through the notches on the right and
left side of the pump.
• Close the pump door by firmly placing pressure with both hands on each side of the
pump door, continue to press firmly until you hear and feel the motorized door
latch pull the door shut. Do not open roller clamp until the pump directs you to do
so when self test is completed.
Caution: Pump door will not close if the anti free flow clip is not
properly inserted. Do not force door closed - if door is too difficult to
close, check IV line and anti free-flow clip (green) for proper loading.
Caution: Before opening door, close roller clamp. If the door hook
appears damaged or broken remove the pump from service.
• If priming is activated, press u to select yes to prime IV line and note prompt to
disconnect IV line from patient before priming. Press k to confirm and begin
priming. Respond to "priming stopped" message by confirming with k. Respond to
"repeat priming" prompt with u for yes if line is not fully primed or d for no if
fully primed. Please refer to the priming volume on each disposable label.
19
OPERATION
Chapter 1
Note: During priming, all air in line alarms are inactive.
• Connect IV line to the patient and observe B. Braun landing page. Press k to
program infusion.
Note: Pump automatically powers up in the drug library for all new infusions.
Note: Last infusion, if any, will be displayed with prompt "Continue last infusion?".
Press u for yes or d for no. If yes, confirm each infusion parameter by scrolling with
t and pressing k to confirm values. If no, press k on B. Braun landing page to
program new infusion.
1.2 Drug Library
The Space Infusomat powers up in the drug library, providing a safety net for clinicians
during programming.
The drug library allows for up to 1200 drug names in up to 10 concentrations per drug
to be sub-divided into 30 categories. These drugs can be assigned to 50 care units and
16 Patient Profiles. Drug categories allow the drug names to be subdivided, such as by
drug type. Patient profiles allow one drug to have different settings such as dose limits,
concentration, clinical advisories, pressure limits, and infusion type based on patient
type or condition. Care Units allow drugs to have different settings based on location
or classes of patients.
• The pump will prompt user to enter weight for weight based dosing and BSA for m2
dosing.
Note: Changing the weight during a weight based infusion or BSA during a m2
infusion will result in a change in the infusion rate to deliver the programmed dose at
the new weight.
20
OPERATION
Chapter 1
• Weight or BSA may be changed by scrolling to weight or BSA on home screen and
editing weight or BSA.
• Drugs may have a clinical advisory set up in the drug library which must be
confirmed by pressing l or k before proceeding.
Note: It is possible to view the clinical advisory at any time by accessing the Status
menu from the home screen and scrolling to Drug Info, see Chapter 2.3 for details on
the Status Menu.
The Drug Library provides the ability to set limits for continuous infusions around rate
or doserate, intermittent infusions with limits on dose and time, loading dose and programmed bolus doses with dose and rate. In addition, default values may be entered in
the drug library and will be populated in the infusion parameters on the pump, these
values may be edited.
The Drug Library allows both soft and hard limits to be set. Soft limits may be overridden or value re-programmed per your institutional policy. Hard limits may not be
over-ridden. The soft limit symbol appears to the left of the run screen, as seen in
figure below, to indicate when infusion is within, below or above limits.
Soft Limits:
The following symbols describe the display status with regard to the limits:
The infusion is within the range of the lower and upper
soft limits
=
The infusion is below the upper soft limit
=
The infusion is above the upper soft limit
=
The infusion is above the upper soft limit
=
The infusion is below the lower soft limit
=
No soft or hard limits are set
=
21
OPERATION
Chapter 1
Drugs may be marked for PRIMary only, SECondary only or both in the drug library.
When selecting drugs, in the library drug names will only appear if marked for that
mode in the drug library file. In addidtion a drug may be marked to deactivate
SECondary mode.
Hard Limits:
Two types of hard limits are possible. Hard limits may be set in the drug library
for rate/doserate, and amount or time of administration for each drug. If the set
rate/doserate (continuous, bolus or loading) or amount (dose or volume) is outside the values set in the drug library as a hard limit it is not possible to exceed
the hard limit.
In addition the pump has hard limits, the maximum rate of 1200ml/hr cannot
be exceeded. Additionally, the pump may be set in the configuration file to
have maximum limits for both continuous and bolus rates which cannot be
exceeded, these also produce hard limit alerts when attempting to program
values which exceed the set limit.
The hard limit message stays on the screen until confirmed by the user and the editor
reverts to the last value that was confirmed.
Below are 3 examples of values entered that exceed the hard limit of the drug library
or the pump:
Example 1:
Drug with a upper hard limit set at 15 mcg/kg/h
Current value is 10 mcg/kg/h
Pressing the u once with the cursor in the tens column would produce a value of 20
mcg/kg/h which is above the hard limit of 15 mcg/kg/h. The pump displays 15
mcg/kg/hr, the hard limit value.
22
OPERATION
Chapter 1
When the u is pressed again the hard limit message is displayed and remains until
confirmed by pressing k.
Upon pressing the k button, the pump editor field reverts to the last confirmed
value programmed prior to the value that created the alert.
Example 2:
Drug with a lower hard limit of 0.2 g
Current value is 0.3 g
Pressing the d once with the cursor in the tenths column displays value
of 0.2 g which is at but not below the hard limit.
When the d is pressed once again with the cursor in the tenths column the hard
limit message is displayed and remains until confirmed by pressing k.
Upon pressing k the pump editor reverts to the last confirmed value programmed
prior to the value that created the alert.
23
OPERATION
Chapter 1
Example 3:
Pump maximum rate is 1200ml/hr
Current value 1100ml/hr
Pressing the u once with the cursor in the hundreds column displays value
of 1200ml/hr which is at but not above the hard limit.
When the u is pressed once again with the cursor in the hundreds column
the hard limit message is displayed and remains until confirmed by pressing k.
Upon pressing k the pump editor field reverts to the last confirmed value
programmed prior to the value that created the alert.
Note: It is important to carefully check default values to be certain they match
physician order.
24
OPERATION
Chapter 1
1.3 Programming a PRIMary Infusion in Drug Library
When the IV line has been loaded and primed, the B Braun landing page appears.
• Press k to program an infusion.
Note: Programming of infusion parameters may be done prior to loading the IV
line by pressing k from this screen.
• Select the Care Unit using the u and d arrows to scroll through the list
and press the l arrow or k key to make selection.
Note: A basic infusion may be selected from this list. Basic infusions are
addressed in Section 1.11.
Scroll bar
Note: Scroll bar appears on all screens when additional information is available, use
arrow keys to scroll. In all menus the screen always loops back to the top when
bottom of list is reached.
• Select patient profile using Q arrow keys and confirm with l arrow or
k. If no profile is set in the drug library, this step will be skipped.
• Select the drug category using Q arrow keys and confirming with l arrow
or k. "All drugs" may be selected or search by specific category. If no
categories have been set in the drug library this step will be skipped.
• All drugs are listed alphabetically. Navigate through the list with u and d
arrows or use l and r arrows to quickly skip through the alphabet in
groups of 3 (i.e. ABC-DEF) . Press l arrow or k to select drug.
25
OPERATION
Chapter 1
Note: Care unit may be changed on any of the above navigation screens. This will require re-programming the therapy when a care unit change is done prior to beginning
the infusion. See Section 1.9 for instructions on changing the Care Unit while infusing.
• Choose drug concentration using u and d arrows, press l arrow or k
to select.
Note: Some drugs may be set up for more than one infusion type, such as Continuous
and Dose over Time, choose the mode using u and d arrows. Select with l or k
key. Refer to Section 1.5 for instructions on Dose over Time therapy.
• After drug and concentration selection, the home screen will be displayed
with rate, doserate or total dose highlighted in white depending on the
infusion type and drug library settings. To program rate or doserate press
l arrow or k to open the editor screen. The total dose editor will be displayed for Dose over Time infusions.
• When editing parameters, use the r and l arrow keys to move to the
digit to be programmed. The white background indicates current digit. The
c key may be used to clear existing values. Use u or d to program new
values. Text on the bottom of the screen indicates the parameter that
changes based on programmed value in the editor, as an example if rate is
being edited the time will appear on bottom of screen and will change based
on rate change (this requires VTBI to have been entered). The top of the
screen indicates infusion mode, confirm value with k , and soft limit
symbol.
26
OPERATION
Chapter 1
Note: Home symbol is displayed in upper left of home screen. Home screen may be accessed from run screen by pressing c key.
Note: Default values may be present when set in drug library, in this case the editor
screens do not appear, confirm values and press f
s to begin the infusion or press l
arrow to edit default values. Observe green LED and arrows moving right to left in
upper right of display indicating infusion is running.
Note: It is necessary to confirm that default values match physician order.
Note: While programming, the soft limit symbol appears above the value, indicating
where the value is in relation to the soft limits.
• Soft Limit Warning: a soft limit warning will be generated upon confirming a
value that is outside the soft limit set in the drug library. A prompt will
appear asking to override with programmed value. Press d for No to reprogram, editor will appear with previously confirmed value. Press u for
yes to over-ride soft limit.
Note: Change in soft limit symbol when over-ridden.
• Hard Limit Warning: when a hard limit value is exceeded, a message is displayed indicating the value exceeds drug or pump limits. Press k to confirm
alert, pump returns to the editor screen to re-program.
Note: The Space Infusomat may deliver rates to 1200ml/hr. It is possible in the service
program to set lower rate limits for continuous and bolus infusions. When these limits
are set in the pump configuration file a hard limit alert is generated when
programming exceeds set pump limits.
• Scroll down to enter and/or review VTBI and Time. VTBI is required to start
the infusion. Time will be calculated when VTBI is entered. When time is
entered, VTBI is calculated if rate/doserate has been programmed.
27
OPERATION
Chapter 1
• When all parameters have been entered and confirmed with k, “Start”
appears in upper right of display.
• Press f
s to begin infusion.
Note: PRIM will appear in upper left of screen to indicate PRIMary is running. When
pump is stopped, PRIM appears next to home symbol.
Titration: The doserate/rate may be titrated while the pump is running.
• Press l arrow key to open editor.
• Program desired value, press k to confirm, the new doserate/rate is not
active until confirmed.
Failure to confirm the new value results in a reminder alarm in 30 seconds. The pump
continues to infuse at the old rate until confirmed.
Note: Respond to soft and hard limit dose alerts that occur during titration as
described above.
1.4 Programming a SECondary Infusion in the Drug Library
The Space Infusomat allows SECondary (piggyback) infusions to be programmed. Spike
bag and prime SECondary tubing manually, close roller clamp and connect to primary
tubing at needleless port above the pump.
• Stop PRIMary infusion by pressing f
s key.
• Scroll to SECondary menu by pressing d arrow.
• Select SECondary by pressing l arrow or k key.
Four sub-menu items will be displayed: New SECondary, Use a Previous SEC infusion,
Back to PRIM and Basic Infusion.
28
OPERATION
Chapter 1
"Back to PRIM" allows the pump to be set to require a manual switch back to PRIMary
in which case the pump stops and alarms when the SECondary is complete, or autochange whereby the pump converts to the PRIMary setting when the SECondary
dose/VTBI has been infused.
Note: The method of switching back to PRIMary remains for all SECondary infusions
until changed.
• Select "New SECondary"
• Select the drug category and scroll to the desired drug name.
The Care Area and Patient Profile are retained from the PRIMary infusion. Select
infusion mode and concentration as done above whenprogramming a PRIMary
infusion.
Note: Medications may be set up in the drug library for SECondary only and will only
appear in the drug list when in the SECondary menu.
Note: PRIMary medications may be set in drug library to prohibit SECondary infusions.
A message will appear indicating SECondary has been disabled for the drug.
SECondary meds, which are administered intermittently, will most frequently be set up
for Dose over Time. SECondary meds set up as continuous are programmed as above
for PRIMary programming.
• Enter total dose and confirm with k.
• Enter total time and confirm with k.
Note: The pump calculates the rate and VTBI.
s key, note message reminder to check bag height and unclamp
• Press f
secondary.
• Press f
s again to confirm message and start SECondary.
29
OPERATION
Chapter 1
Note: The SECondary bag must be hung at least 8 inches above the PRIMary. The
8 inch interval is measured from the bottom of the SECondary bag to the top of fluid
level in the PRIMary.
30
OPERATION
Chapter 1
Note: When running a SECondary infusion at rates greater than 300ml/hr clamp off
the PRIMary infusion to prevent concurrent flow.
Dose over Time run screen will indicate drug name and count down remaining time.
Note: During SECondary administration, the PRIMary may be resumed at any time by
pressing the f
s key to stop the SECondary infusion, scrolling to and selecting "resume
PRIMary", selecting it with l or k switches back to the primary infusion. Pressing
f
s leads to an acknowledging prompt to clamp or remove SECondary, then pressing
f
s key to infuse PRIM. To resume SECondary, stop PRIM and scroll to and select
"resume SECondary". The menu item "resume SECondary" will not appear if the
SECondary dose/volume was completed.
• To stop and clear a current SECondary infusion prior to completion of dose/
volume, press f
s key, then press c key, then press u arrow to answer
yes to "Clear SECinfusion". SECondary drug will remain in the list of previous
SECondary infusions.
The Space Infusomat stores up to 5 of the previously administered SECondary
medications for easier programming of repetitive SECondary medications. The
previous SECondary medications are cleared when the Care Unit changes, the pump is
powered off or answering “yes” to New Patient when bar coding.
Note: When a SECondary medication with the same name but different concentration
or dose is programmed, the prior medication with that name is deleted from the list.
SECondary infusions which are cleared prior to completion will remain in the list of
previous SECondary medications.
• Stop PRIMary by pressing f
s key.
• Scroll to SECondary menu and select by pressing l arrow or k key.
• Select "Use a Previous SECondary" by pressing l arrow or k key.
31
OPERATION
Chapter 1
• Scroll to desired drug, press l arrow or k to select.
• Confirm previous values by scrolling to each parameter. When all are checked
press k to confirm and then press f
s to begin infusion.
Note: Reminder to check bag height and unclamp SEConday will appear, press f
s
again to begin SECondary infusion.
1.5 Programming an intermittent Dose Over Time
Infusion
Dose Over Time is used to administer a specific dose of a medication in a specific time.
Dose Over Time can only be used within the drug library in either the PRIMary or
SECondary mode. Limits can be set around both total dose and total time in the drug
library. The rate and VTBI are calculated based on the drug concentration, dose and
time. The rate may not be edited.
Note: Changing the VTBI will result in a change to the dose and the rate.
The
symbol appears next to the mode symbol on the pump display when a
medication is set up as Dose over Time.
To Program a Dose over Time infusion:
• Selected drug must be set for dose over time in the drug library.
• Choose drug per steps above in Section 1.3.
• Enter weight or weight and height as prompted based on dose settings in
drug library.
• Enter total dose and press k to confirm.
32
OPERATION
Chapter 1
• Enter Total time and press k to confirm.
Note: When default values have been set in the Drug Library there will not be a prompt
to enter values. Values may be edited by scrolling to the parameter and pressing the
l arrow key.
Note: The KVO and Bolus functions are disabled during Dose Over Time.
1.6 Programming a Loading Dose in Drug Library
The Infusomat® Space allows for the delivery of a loading dose for medications that
have been set up in the drug library for loading dose. Loading doses may have soft and
hard limits set in the Drug Library. The pump will prompt and allow the user to proceed with a loading dose or go right to the continuous infusion. Once "No" has been
selected to "Program Loading Dose?" it is not possible to recall it on the pump without
exiting and clearing the infusion by pressing the c key and re-programming the
drug from the beginning.
To Program a loading dose:
• Press u arrow to answer yes to loading dose prompt.
• Enter loading dose amount using q arrow keys, confirm with k.
• Enter loading dose time using q arrow keys, confirm with k.
33
OPERATION
Chapter 1
Note: Soft and Hard limit alerts will be generated based on drug library settings.
• Press l arrow key to access doserate/rate editor to set continuous infusion.
• Enter doserate or rate for continuous infusion and confirm with k.
• Enter VTBI or Time.
Note: "LD dose and Start" alternate in upper right corner of screen.
• Press f
s to begin infusion.
Note: The word LOAD is super-imposed on the run arrows.
Note: The loading dose may be stopped at any time by pressing the f
s key. Press f
s
key to deliver remaining loading dose. There will be nothing infusing until Load Dose is
resumed or cancelled and continuous infusion started.
• When pump is stopped intentionally or by an alarm state, the pump will
display the amount that has been delivered of the total amount
programmed. Press k to confirm.
• Upon pressing f
s , the pump will prompt to deliver remaining loading dose.
Press u arrow for yes, d arrow for no.
34
OPERATION
Chapter 1
Note: Once "No" is selected it is no longer possible to recall the loading dose.
1.7 Programming a Bolus with Dose and Time in the
Drug Library
The Infusomat® Space allows for delivery of a programmed bolus for drugs which have
been set up in the drug library for bolus dosing.
• Press yellow b
n key.
• Select Program bolus dose and time.
Note: Drugs which do not have manual bolus enabled will skip this step.
• Select dosing unit and confirm with k key.
Note: Pump defaults to bolus units set in the drug library. If the bolus ordered is in
different units, press the u or d arrow key to change units. The pump will perform
all necessary calculations and apply dosing limits set in the drug library.
• Enter Bolus amount and confirm with k.
• Enter Bolus time and confirm with k.
n to begin bolus.
• Review and confirm bolus parameters and press b
35
OPERATION
Chapter 1
Note: The word Bolus superimposed over the run arrows is displayed on the screen.
Note: Failure to press BOL to start bolus will result in reminder alarm.
• The pump will automatically convert back to the continuous infusion when
the bolus is complete.
Note: The bolus may be stopped at any time by pressing the c key, the
continuous will then run. Press b
n key to deliver remaining bolus.
• Press f
s to stop the infusion entirely.
• When bolus is stopped intentionally by pressing c key,or pump is stopped
by an alarm state, the pump will display the amount that has been delivered
of the total amount programmed. Press k to confirm.
• If pump was not running, as after an operating alarm, press f
s to begin the
infusionand respond to prompt to deliver remaining bolus per above.
The last bolus dose is recorded in the status menu, refer to ch. 2.3.
1.8 Manual Bolus
The Infusomat® Space allows for the delivery of a manual bolus when the drug is set
up in the drug library for a manual bolus. A manual bolus requires the user to
continually hold the bolus button to deliver the bolus.
36
Note: Drug library limits do not apply to manual boluses.
OPERATION
Chapter 1
To deliver a manual bolus:
• While an infusion is running, press b
n key.
• Select “Use Manual Bolus feature”.
• Press and hold b
n key.
• Bolus amount will count up on pump display.
Manual bolus is limited to 10 seconds.
The pump may be set to emit an audible tone every 1ml of solution delivered.
Bolus amount will be displayed when 10 seconds is complete or b
n key is released.
n key is released or
The pump converts to the continuous infusion when the b
10 seconds is completed.
1.9 Changing Care Unit
The Infusomat® Space allows the Care Unit to be changed when patients are transferred. All drug library limits for the new Care Unit are immediately applied and a limit
alert appears if soft limits are exceeded in the new Care Unit. If a hard limit is exceeded
the pump reverts back to the previous Care Unit. The pump does not allow a Care Unit
change in the following circumstances: during SECondary infusions, if the drug or
concentration are not available in the new Care Unit and if hard limit is exceeded.
To change a Care Unit:
• While infusion is running press the c key to get to home screen.
• Scroll to “Change Care Unit”, select with l arrow or k key.
• Scroll to desired Care Unit and select with left l or k key.
• Pump will display confirmation of new Care Unit.
37
OPERATION
Chapter 1
The doserate, dose or time editor will appear and required confirmation if parameter
exceeds the soft limit in the new Care Unit. The soft limit warning will be shown
requiring an over ride or new programming to proceed as in Section 1.2. Pump will
display message if Care Unit was not changed because drug or drug concentration is
not available in new Care Unit or hard limits are exceeded.
1.10
Changing display while pump is running
• While pump is running, press d arrow to choose preferred value to display
on bottom left corner of display.
Values displayed will vary with type of therapy and may include drug long name, concentration, volume totals, remaining time, care area, etc. Displayed value will remain
until changed by user.
1.11
Basic Infusion (programming the pump outside of
the drug library)
The Infusomat® Space allows programming outside the drug library, referred to as a
Basic infusion. To program a Basic infusion, select “Basic Infusion” from the Care Unit,
Patient Profile, Drug Category or Drug selection screens.
Note: Basic infusion may be selected in the SECondary menu.
• The pump provides a prompt that programming outside the drug library has
no safety limits, press k.
38
OPERATION
Chapter 1
• A second prompt requires responding yes with u to "Continue without limits".
• Respond “yes” or “no” to "Use dose rate calc?" (if configured). See Section 2.2.4.
Note: While under Basic Infusion, the pump is not using any drug library safety limits.
• The pump requires user to enter 2 out of 3 of the following parameters: rate,
VTBI or time. When 2 are entered, the pump calculates the 3rd parameter.
SECondary, programmed bolus and manual bolus are also available in Basic mode, See
Section 1.4, 1.7, 1.8. The target symbol
appears next to the programmed value,
other than rate, that was first set by the user. When a rate titration is made the value
with the
is not changed, rather the 3rd calculated value is adjusted for the new
rate. As an example if a rate of 10ml/hr and time of 20hrs is programmed the VTBI is
calculated, when rate is titrated the VTBI is changed not the time. If the rate and VTBI
are initally programmed the time would change with a change in rate. The parameter
with the target symbol does not change during titration of either of the other 2 parameters.
1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the
bottom of the display.
• 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.
Rate titration will result in adjustment of time. Alternatively:
2.) Enter rate and VTBI: The infusion time will be calculated and displayed on the
bottom of the display.
Rate titration will result in re-calculation of time.
39
OPERATION
Chapter 1
3.) Enter rate and time: The infusion volume will be calculated and displayed on the
bottom of the display.
Rate titration will result in re-calculation of VTBI.
1.12 IV Line Change and New Therapy Start
Note: Always close roller clamp and disconnect the line from the patient before
changing a line to avoid inadvertent free flow.
• Press f
s to stop the delivery. The green LED goes out. Close the roller clamp
and disconnect line from the patient.
• Press x and open the pump door with u. Once door finishes opening
automatically, pull down on door to fully open. Expect some resistance. Press down
the green opening lever completely until it locks in place, releasing the pump based
safety free flow clamp, and yellow light flashes, then remove the IV line from right
to left and insert a new IV line, note that green anti-free flow clip occludes the
IV line when removed.
Note: In the unlikely event the pump door cannot be opened remove the allen key
from the inside of the battery compartment cover. Use this key to remove the
emergency aperture cover of the pump. Place the crank in the aperture and turn it
clockwise until the pump door opens.
Push cover opening with pen.
Remove crank from inside of battery
cover.
40
OPERATION
Chapter 1
Turn crank to remove emergency
aperture cover.
Remove emergency aperture cover.
Turn crank inside aperture to open the
door.
• Insert new lV line per Chapter 1.1. Close the pump door and open the roller clamp.
• If prompted, prime the pump with u. Then press d to proceed when priming is
complete.
• Connect IV line to patient and check the parameters with t.
s.
• Start the infusion by pressing f
Note: A new infusion can be started at any time during a stopped infusion. Press c
and respond yes to prompt "Exit and clear infusion". Note prompt will indicate if
PRIM, SEC or both will be cleared depending on current pump mode and infusion
status. B. Braun landing page will be displayed.
1.13 End of Infusion
• Press f
s to stop the infusion. The green LED goes out. Close the roller clamp
and disconnect the line from the patient.
41
OPERATION
Chapter 1
• Press x and open the pump door with u and remove IV line per above in
Section 1.12.
• Close door and press o for 3 sec to power off the pump.
Note: When pump is powered up user will be prompted to continue last infusion,
answering No returns to B. Braun landing page.
Note: Pump cannot be powered off with IV line inserted.
1.14 Standby Mode
The pump may be placed in standby rather than powering off so that re-starting an
infusion is quicker.
• Press f
s to stop the infusion, leave IV line inserted in pump. Then press and
hold o for 3 sec.
• The pump is now in Standby.
While the pump is in the standby mode, the display shows infusion mode, drug name
and the remaining time for standby mode. Change remaining time by pressing l,
standby may be set from 1 min to 24 hours. Exit standby by pressing c. The pump
will alarm when the standby time expires.
• Press c to cancel standby.
42
PUMP MENUS
Chapter 2
PUMP MENUS
Menus are accessed from the Home screen using the q arrow keys. Press c key
while pump is running to access home menu. All menus may be accessed while the
pump is running except the SECondary menu. Features displayed in the menus are
determined by your facility and set in the service program. All features listed below
may not be available.
• To edit a menu item, select the desired menu item in the Home screen and
press L. Then select desired function with t and follow the directional
arrow prompts.
2.1 Infusion Totals
• Infusion totals may be cleared by scrolling to “Infusion Totals” while in Home
screen. Select with l. Primary, Secondary and Total of both are displayed.
Scroll and select desired value, respond to prompt to zero the value.
Note: Infusion totals are cleared when cleared by user, when No is selected to
“Continue Last Infusion” on power up or “Yes” is selected to New Patient during bar
coding.
43
PUMP MENUS
Chapter 2
2.2 Options
2.2.1 Downstream Occlusion Pressure
The higher the pressure level is set, the higher the pressure level must rise before triggering an occlusion pressure alarm.
• Enter "pressure" in Options Menu by pressing l to set downstream pressure limit.
• Choose between nine pressure levels (1=lowest level; 9=highest level) by pressing
l or r and confirm entry with k. Pressure levels and equivalent mmHg are
displayed when left arrow is pressed while in pressure menu.
Note: The pressure will remain at set level until changed by user unless the drug
selected had a pressure level set in the drug library. When pump is powered off
pressure level returns to default value set in service program when powered back on
unless drug selected has a different pressure level set in the drug library.
2.2.2 Upstream Occlusion Pressure
The device is equipped with an upstream pressure sensor that detects an
occlusion (e.g. closed roller clamp, kinked line) between the container and the
pump. The higher the pressure level is set, the lower the pressure level must
drop before triggering an upstream occlusion pressure alarm.
•
Access upstream pressure in Options Menu by pressing l.
•
Choose between nine pressure levels (1=lowest level; 9=highest level) by
pressing l or r and confirm entry with k.
2.2.3 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.
2.2.4 Dose Rate Calculator
The Dose Rate Calculator may be used to calculate a doserate for a medication
that is not in the drug library. While the pump will calculate the rate, it is
44
PUMP MENUS
Chapter 2
important to realize there are no dose limits.
• To access the Dose Rate Calculator go to the Home screen and scroll to
Options.
Note: Pump may be set up in service program to prompt “Use Dose Rate
Calculator?” when a basic infusion is selected.
• Press k to prompt to select concentration units.
• Scroll to and select units for concentration (units of drug in bag) using q
arrow keys, confirm with k.
• Press k to prompt for entering amount of drug in bag.
• Enter the amount of drug using q arrow keys and confirm with k.
•
Press k to prompt for entering the volume of the bag.
• Enter the volume of the bag using q arrow keys and confirm with k.
45
PUMP MENUS
Chapter 2
• Select patient parameter, if any, for dosing calculation. Choices are weight,
BSA, or none.
• Select the doserate units.
• Enter doserate using q arrow keys and confirm with k.
Confirm and start infusion.
• *Enter VTBI or Time.
• To exit Dose Rate Calculation: the pump must be stopped. Press the c Key
from Home screen and answer “yes” to “Exit and clear infusion?”
Assigning a basic or doserate calculation infusion to Drug Library:
An infusion started without using the drug library, either a basic or doserate
calculation, may be assigned to the drug library without stopping the infusion.
• Access the Home screen by pressing the c key.
• Scroll to and select Options.
• Scroll to and select “Assign to Drug Library”.
•
46
Program for the Drug Library following the same steps covered in Chapter
1.3 to program within the drug library, beginning with selecting the Care Unit.
PUMP MENUS
Chapter 2
2.2.5 Data Lock
The pump offers 2 levels of security to prevent unauthorized access which may
be set in this menu. A third level may be set in the drug library by drug. A four
digit code (default setting “9119”) must be entered within 20 seconds to prevent
a data lock alarm. The code can be changed via the service program for Level 1
and Level 2.
Level 1:
All keys except X door open and f
s are locked and require entry of data lock
code. The IV line may be changed.
Level 2:
Functions the same as level 1 and in addition does not allow the door to be
opened and requires code to start infusion.
Note: Once code has been entered changes may be made for 20 seconds until
the pump locks again and requires re-entry of the code.
Level 3:
Functions the same as level 2 but has a custom code set in the Drug Library. In
addition the pump display may have a custom message.
Event
Change IV line
Level 1
Level 2

Start infusion
Change parameters
Stop infusion
Powering off pump / Standby
Displays customized message when
running

NA


%

Level 3
 with code for
level 2/3

%
NA
= possible |  = requires code | %= followed by data lock alarm
Activation of the function:
•
Open data lock in Options Menu with l.
•
Select between level 1 or 2 with l and r and confirm with k.
•
Enter code with q and press k in order to activate data lock.
47
PUMP MENUS
Chapter 2
• Note that upon activation of data lock the y symbol appears on the run
screen to the right of the rate/dose indicating changes are only possible after
entering the code. If the wrong code is entered four times the pump will go
into an audible alarm, the yellow LED will light, and the pump display
indicates invalid code.
• To deactivate data lock, select “Off” in the data lock menu, press k.
2.2.6
KVO-Mode
The pump can continue the infusion with a preset KVO rate after an infusion time or
VTBI has ended. The rate and duration of the KVO delivery is set in the service program.
When KVO feature is activated in the service program, the pump will automatically go
into KVO unless it has been turned off in the Options menu.
• Open the KVO mode in the Options menu with l.
• Answer the Yes/No question with u to activate the KVO mode.
Note: KVO function is disabled in Dose over Time.
2.2.7 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.
48
PUMP MENUS
Chapter 2
2.2.8 Bolus Rate
The pump has a default bolus rate which is set in the service program. This rate is used
for manual bolusing. For a programmed bolus, this rate will be converted to a time in
the time editor screen if no default bolus rate has been set in the drug library and may
be changed by adjusting the time.
• Open bolus rate in Options Menu with l.
• Change bolus rate with q and confirm setting with k.
2.2.9
Date / Time
• Open date/time in the Options Menu with l.
• Modify date and time with q and confirm the setting with k.
2.2.10
Macro Mode
The infusion rate appears much larger and the drug name much smaller 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.
Note: For quick activation and deactivation of macro mode: Press and hold r while
the pump is infusing until the font size changes.
2.2.11
Wireless Activation
Allows wireless to set for active or inactive.
2.3 Status Menu
The status menu is accessed from the Home screen. In the status menu it is possible to review the following:
• Battery time remaining at current infusion rate
• Last bolus amount, date and time
• Drug info which includes Care Unit, drug file creation date, current drug selection,
patient profile and clinical advisory (if any).
• Pump software version
• Wireless status
• IV line
49
PUMP MENUS
Chapter 2
50
ALARMS
Chapter 3
ALARMS
The Infusomat® Space is equipped with an audible and optical alarm signal.
Alarmtype
Device
Alarm
Audible
signal Red LED
yes
flashes
Optical signal
Yellow LED Text
off
device alarm
and alarm
code
Staff call
User confirmation
yes
Follow the instruction on the display
to press k.
Operating
Alarm
yes
flashes
off
alarm type
yes
Press k to
acknowledge and
cancel alarm
PreAlarm
yes
off
constant
on
alarm type
(de-)activate Press k to acknowledge and cancel
via service
alarm
program
Reminder yes
Alarm
off
constant
on
alarm type
yes
Press k to acknowledge and cancel
alarm
Alarm
Hint
off
off
alarm type
no
Message disappears
without confirmation.
no
3.1 Device Alarms
When a device alarm occurs the infusion is immediately stopped and display indicates
"device alarm" with a code. The audible alarm is unique. Press o to switch off the
device. Then switch the device on again. In the case of a repeated device alarm the
pump must be sent for service.
3.2 Pre-Alarms and Operating Alarms
Pre-alarms:
Pre-alarms are set in the service program. Pre-alarms occur a few minutes (specific
time set in service settings) prior to operating alarms. During pre-alarms an audible
tone sounds, the yellow LED is constantly on and a staff call is activated (optional). The
display message varies depending on the reason for the alarm. The signal tone and the
staff call are turned off with k. Display and LED stay in pre-alarm until condition
causing the pre-alarm results in an operating alarm. Pre-alarms do not stop the infusion.
Display message
Pre-alarm reason
“VTBI near end“
The programmed volume is almost infused.
“Time near end“
The programmed time is almost over.
“Battery nearly empty“
The battery is almost discharged.
“KVO mode“
VTBI or time are complete and the pump
converted to the KVO rate.
51
ALARMS
Chapter 3
A stopwatch on the display counts down the remaining time (depending on the
service program, between 3-30 min). After that, the pump goes into an operating alarm.
Operating alarms:
Operating alarms immediately stop the infusion. An audible tone sounds, the red
LED flashes and a staff call is activated (optional). The display states “Alarm“
and the reason for the operating alarm. The alarm tone and message as well as
the staff call are turned off with K. Correcting the alarm state depends on the
cause of the alarm.
52
Display message
Alarm reason
“VTBI infused “
The programmed volume was infused.
Hang new bag and/or reset VTBI
“Time expired“
The programmed time has ended.
Hang new bag and/or reset time.
“Battery empty“
The battery is discharged.
The battery alarm will be on for 3 min.
Then the pump will automatically turn off. Plug
pump in immediately to re-charge battery.
"Downstream occlusion"
The set downstream pressure level was exceeded. Post
occlusion bolus reduction is automatically initiated by
the pump.
Check tubing for kinks , closed stopcocks, filter
patency, and IV site.
Increase occlusion pressure if necessary per your
institutional policy.
“KVO time finished“
The KVO time has ended. Program new settings.
“Battery cover removed“
The battery cover is not properly engaged on the
battery compartment.
Reposition cover, listening for click when battery
cover is locked in place.
“Standby time expired“
The set standby time has ended.
Set new standby time or initiate infusion.
“No battery inserted“
It is not possible to use the pump without a
battery.
Turn off pump and insert battery according
to directions in “Overview Infusomat® Space“.
“Drive blocked“
Excess pressure in system or motor failure. Remove
tubing and re-insert, if persists pump must be sent for
service.
“Calibrate device“
Return to service for calibration.
ALARMS
Chapter 3
Display message
“Upstream occlusion above pump"
Alarm reason
The upstream pressure between the bag and the
pump is high.
Check if roller clamp is closed, or infusion line is
kinked.
“Air bubble alarm"/
"Accumulated air exceeds limit“ Air detector limits are set in the service program. The
air bubble size can be set between 0.02 - 0.3ml in
increments of 0.01. The accumulated air value may
be set between 0.5 - 3.8ml/hr in increments of 0.1ml.
The display will indicate air bubble or accumulated
air as the cause of the alarm. When an air alarm is
cleared (disconnect line from patient and follow
display prompts to prime the air bubble out or follow
hospital protocol) the system resets to zero.
“Pump set back to default
settings”
Pump settings could not be restored.
Enter infusion parameters again.
"Infusion values were cleared” Infusion data could not be restored.
Enter infusion parameters again.
“Data lock"
Danger of FreeFlow Clamp IV line
An attempt was made to access the pump without
entering the code.
Enter the correct code.
Anti-free flow clip not properly inserted. Close roller
clamp, open door and re-insert IV line.
The red LED extinguishes with the acknowledgement of the operating alarm.
3.3
Reminder Alarms
Reminder alarms occur in 2 different scenarios.
1. A line is inserted, the pump is not infusing, programming is incomplete, and there
has been no interaction with the pump for two minutes.
An acoustic tone sounds, the yellow LED is constantly on and a staff call is
activated (optional).
a) The display states “Reminder alarm” and reason for alarm.
b) The display states “Programming not done”
Confirm alarm with K and continue to program.
53
ALARMS
Chapter 3
2. An editor screen was open for programming but no values were confirmed or values
were entered but no line is inserted in pump.
An acoustic tone sounds in 20 seconds, the display states “Value not confirmed“,
the yellow LED is constantly on and a staff call is activated (optional).
Confirm alarm with K and continue to program infusion.
Sample reminder alarms include:
Display message
Alarm reason
“Bolus NOT running“
BOL was not pressed after programming bolus dose
and time.
“Order still pending”
Autoprogramming order was sent to pump but not
confirmed.
3.4 Alarm Prompts
A prompt provides direction to assist in properly operating the pump. (e.g. “Bolus function disabled”, “Download failed”, or “The parameter can not be modified”).
54
WIRELESS DRUG LIBRARY UPLOAD
Chapter 4
WIRELESS DRUG LIBRARY UPLOAD
The pump has the ability to accept new drug library files wirelessly. A file
symbol will flash alternately with the wireless antenna symbol on the top of the
pump display when a new file is available. The wireless antenna symbol is seen
on run screen, standby screen and when pump is powered off and plugged in.
• Press Start/Stop key f
s to stop infusion when patient condition allows.
• Close roller clamp, disconnect IV line from patient, press x and remove
IV line from right to left per Section 1.12 and 1.13.
• Power pump off.
• Wait 10 seconds, progress bar appears on pump, do not power pump back
on until Drug Upload is complete as indicated by progress bar.
• Display will indicate DL update is successful when complete, on power up
display indicates new Drug Library is activated on pump.
Note: Cancelling the Drug library update will remove all drug library files from
the pump. A small drug library may load very quickly and not be able to be
cancelled.
55
WIRELESS DRUG LIBRARY UPLOAD
Chapter 4
• Press power key o to re-start pump, respond to 2 prompts that all values
are cleared and new Drug Library has been loaded.
• Confirm prompt that previous programming values have been cleared.
New drug library has been activated on pump.
56
AUTOPROGRAMMING AND BARCODING
Chapter 5
A U TO P R O G R A M M I N G
Note: All normal pump functions remain in place when orders are received via
autoprogramming.
The pump can accept drug orders wirelessly from the EHR system. The workflow
to accept an order wirelessly will vary depending on your EHR vendor.
• Using the hand held device or lap top, review the order and follow your hospital
protocol for scanning the bag, pump, patient and nurse (optional).
• Once order is confirmed on the hand held or laptop, prompt EHR to send order
directly to pump. The order will arrive and appear on the pump within 10 seconds.
• Ensure pump is on B Braun landing page (press c key to return to landing page).
• New Order message will appear with drug name and mode.
• Press k to accept or c key to cancel order and respond to prompt.
• Select Care Unit and Patient Profile as in Drug Library programming in Chapter 1.
• Pump will search for Drug Library match.
Note: If no drug library match, which may be due to no matching name, concentration or dosing units, pump displays reason for no match and depending on your
hospitals configuration either allows manual programming outside the drug library per
Chapter 1 Section 1.11 or rejects order completely. An order that is confirmed outside
the drug library will have a triangle with an exclamation point on display to indicate
there are no drug library settings.
• Scroll to each value to confirm using q arrow keys.
Note: Order may be cancelled prior to confirming order.
57
AUTOPROGRAMMING AND BARCODING
Chapter 5
• Once all values are confirmed the Home screen is displayed.
Note: Soft Limit alert will be issued if value exceeds any soft limits set in drug
library, soft limit may be overridden or value re-programmed per institutional
policy. Order will be rejected if hard limit is exceeded. (except in circumstance
where pump service program is not set to perform drug library match for autoprogramming).
For PRIMary Orders:
Note: The first order sent is always considered the PRIMary infusion, subsequent
orders will be considered SECondary.
• Press Start/Stop key f
s to start infusion.
Updates to Current Primary Infusion
Updates may be received for PRIMary infusions while pump is running or stopped and
while in PRIMary or SECondary.
While in PRIMary:
• Update icon will appear on display, follow on screen prompts to accept or cancel
the order. Confirmation screen will indicate both OLD and NEW value for
parameter(s) that changed.
While in SECondary:
• Message will appear on top of display indicating update is available for PRIMary.
• Press M key to view order.
s to accept order or c key to cancel and hold order for
• Follow prompt, pressing f
later.
58
AUTOPROGRAMMING AND BARCODING
Chapter 5
New Primary Infusion:
• To accept a new PRIMary order, stop infusion and clear current PRIMary infusion by
pressing c key and responding “yes” to clear current infusion.
SECondary Orders:
Orders received after PRIMary has been set will be for SECondary infusions,
follow prompts on screen to stop the PRIMary to accept the SECondary order.
• Confirm order values as above for PRIMary orders.
• Respond to prompts to check bag height and clamps prior to starting SECondary.
New SECondary order while SECondary is Infusing:
• Follow display prompts to stop current infusion.
Note: A SECondary order may be held for later by pressing c key to cancel
order and answering yes to “hold for later”.
Note: Changing values on any incoming order may only be done after confirming all values. Once all values are confirmed you may scroll to any value and
open editor with l to change value. Alternately, order may be cancelled and
request made for revised order to be sent.
Note: If pump is placed in standby while order is pending new order will flash
on top of stand by display, press M key to accept order (pump will come out of
standby).
59
AUTOPROGRAMMING AND BARCODING
Chapter 5
BARCODING
Please contact your local B. Braun sales representative for barcoding information.
60
BATTERY OPERATION AND MAINTENANCE
Chapter 6
INTENDED USE
The battery module of Space guaranties operation independent of AC power when
transporting patients within the facility. The wireless battery module contains a
wireless transceiver module to allow data transmission during these transports or
when connected to AC power.
6.1 General
The Infusomat® Space is equipped with the latest Li-Ion battery. The device is
equipped with protection against overcharge and deep depletion.
The battery pack is charged by the pump when connected to AC power. When
disconnected from power or in case of power failure, the pump automatically switches
to battery power.
Note: Prior to a prolonged storage of the pump (> 5 months) the battery pack must be
completely charged and then removed from the pump.
If the battery symbol on the display is blinking while connected to AC power, the
battery is either discharged or has a reduced capacity and pump must remain plugged
in while in 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 lifetime of a battery pack will only be reached if it's completely
discharged from time to time. A maintenance mode which conducts this battery
maintenance is built in. This function should be activated once a month. Furthermore:
• If 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
approximately 500 times before its lifetime decreases.
• When the pump is not connected to AC 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 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.
The wireless is only available when using a battery module with a wireless
transceiver (article code 8713182U) and the wireless function is activated via
61
BATTERY OPERATION AND MAINTENANCE
Chapter 6
the service program (HiBaSeD) or within the Options menu of the pump.
The wireless operation mode supports 802.11 a/b/g/n with static IP-address
setting or DHCP in ad-hoc mode or within an infrastructure.
Caution: Exposure considerations require that a 20 cm (8 inch)
separation distance between users and the installed antenna location
shall be maintained at all times when the module is energized. OEM
installers must consider suitable module and antenna installation
locations in order to assure this in 20 cm (8 inch) separation, and end
users be also be advised of the requirement.
6.2 Safety Instructions
Safety Instruction for B.Braun Battery-Pack SP (Li-Ion)
Battery pack is suitable only for use with B.Braun Space Infusion devices.
Please follow local ordinance and/or regulations for disposal. Fire or chemical burn
hazard if battery is mishandled. To avoid possible injury.
■ Do not open or expose to heat above 80°C (176°F).
■ Do not use damaged Battery-Packs.
■ Do not attempt to disable it.
■ Do not short circuit it.
■ Do not expose it to water or rain.
Caution: If this equipment is modified, appropriate inspection and testing
must be conducted to ensure continued safe use of the equipment.
This device/firmware contains components that are licensed under the
GNU General Public License version 2 (see chapter 9).
To receive the source code of these components as required by that license,
please get in contact with your local distributor.
Caution: The recommandations of the IEC 80001 should be observed.
6.3 Battery with WiFi
Handling the Battery Pack SP with WiFi:
The Battery Pack SP can be exchanged by any user.
No special qualification is required. Replace Battery Pack SP model 8713182U with
corresponding models only. Replace battery pack for Space with battery packs released
by B. Braun. Other batteries may cause injury, fire or explosion.
62
BATTERY OPERATION AND MAINTENANCE
Chapter 6
Caution: The pump must be switched off before opening the battery
compartment.
Open the cover of the battery compartment (see ch. 1.12), unlock the battery by
sliding the green hook and pull out the battery using the metal handle.
Replace the Battery Pack SP in the battery compartment, lock it with the green
hook and test the proper placement by pulling the metal handle. Close the
battery compartment again.
Note: In case of ESD, Pump may need to be plugged into wall outlet to re-start
the battery.
The battery is charged by the pump during connection to A/C power. When
disconnected from A/C or in case of power failure, the pump automatically
switches to battery power.
Connection to A/C power is displayed by the symbol
in the main menu of
the pump. Recharging of WiFi battery while connected to A/C power and active
WiFi is ensured as long as environmental temperature outside Infusion pump is
35 °C (95°F).
Attention: If the battery module is stored for long periods of time outside the pump, it
is recommended to fully charge the battery and store it at room temperature.
Caution: Batteries may explode or leak if they are opened or
incinerated. Consider disposal directions!
The status of the wireless connection is
displayed in the run screen. When the
wireless transmitter is switched off, no
symbol is shown in the status of the run screen.
If the wireless is activated, the status of the connection is shown.
Wireless operation mode is switched
on but no connection to the network.
Note: An “X” through the wireless antenna indicates wireless connection has been lost,
contact your bio-medical engineering or IT department to determine cause.
Wireless operation mode is switched on
on and connection to the network is
established.
Further status information regarding the
status of the wireless connection can be
viewed in the Status menu.
63
BATTERY OPERATION AND MAINTENANCE
Chapter 6
SSID: The Service Set Identifier, is a
the service tool HiBaSeD.
wireless LAN. The SSID can be up to 32
characters long and can only be set with
IP-Address shows the assigned IP address of the infusion pump.
Signal strength: The signal strength shows
the quality of the connection.
Baud rate is the maximum communication speed in mega bits per second (Mbps). The
maximum baud rate strongly depends on the wireless standard (802.11 a/b/g/n).
Status code displays the current status of the wireless connection. If there is a problem
with the wireless connection an error code is displayed. Error codes can be:
10 to 12: internal malfunction
13: wireless interface does not find any network
14: wireless interface is trying to connect to a network
15: the interface is being configured
16: the interface is waiting for authentication
17: DHCP request is sent out
19: internal failure
Available Networks opens a sub menu showing the available wireless networks (SSID)
and their signal strength. It is not possible to change to another network. The Space
pump always connects to the network with the highest signal strength.
Within the Options menu the wireless mode
can be switched on or off.
6.4 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 when the feature is enabled in the service program. The battery maintenance mode detects a possible capacity loss (e.g. through aging of the battery
pack) and then the capacity/running time will be recalculated. After a longer
64
BATTERY OPERATION AND MAINTENANCE
Chapter 6
storage time or a longer operation without battery maintenance the battery
pre-alarm time may no longer be maintained. In this case it is necessary to perform a battery maintenance.
To initiate the discharge process the message “Battery maintenance“ and the k key
will be displayed after switching the pump off. By pressing k and u the discharge
process will start. The process is interrupted by switching the pump on again. If the
battery maintenance is to be continued a new activation is necessary. After completely
discharging the battery it will be completely charged again. The total duration of the
battery maintenance process takes approximately twelve hours.
Caution: When the battery maintenance has not been completed there
is a possibility of a reduced battery operating time.
65
START UP GRAPHS AND TRUMPET CURVES
Chapter 7
START UP GRAPHS AND TRUMPET CURVES
Start Up Graphs
Trumpet Curves
The graphs show the accuracy/uniformity of flow in relation to time.
The delivery behaviour or delivery precision is influenced by the type of the
disposable used. Deviations from the technical data of the pump cannot be
excluded if lines (disposables) other than B.Braun approved sets 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
Measurement duration
Flow Qi
66
∆t = 0.5 min
T = 120 min
(ml/h)
TECHNICAL DATA
Chapter 8
T E C H N I C A L D ATA
Type of unit
Volumetric infusion pump
Classification (acc. to IEC/EN 60601-1)
defibrillator-proof; CF equipment
Protective Class II; Protective Class I in
combination with SpaceStation
Class (acc. to Directive 93/42 EEC)
IIb
Classification acc. to 21 CFR 880.5725
Class II (Product code FRN and FPA)
Moisture protection
IP 22 (drip protected for horizontal usage)
External power supply:
• Rated voltage
• External low voltage
Via B. Braun SpaceStation or optional
AC adaptor (rated voltage 100 … 240 V
AC~, 50/60 Hz) for stand alone operation
11 – 16 V DC
via Connection Lead SP
12 V or via SpaceStation
Staff call
Max. 24 V / 0,5 A / 24 VA
EMC
IEC/EN 60601-1-2 / 60601-2-24
Time of operation
100 % (continuous operation)
Operating conditions:
• Relative humidity
• Temperature
• Atmospheric pressure
30 % – 90 % (without condensation)
+60 – + 105° F
500 – 1060 mbar
Storage conditions:
• Relative humidity
• Temperature
• Atmospheric pressure
20 % – 90 % (without condensation)
-4 – +131° F
500 – 1060 mbar
Type of battery pack (rechargeable)
Operating time of rechargeable battery
Li-Ion
NiMH
Li-Ion
NiMH
wireless active Infusomat at 100ml/h
4.0 hours
wireless active Infusomat at 1200ml/h
2.5 hours
wireless inactive Infusomat at 100ml/h
12.0 hours
wireless inactive Infusomat at 1200ml/h
5.0 hours
at 100 ml/h
13 hours
at 1200 ml/h
5 hours
Recharging time
Approximately 6 hours
Weight
Approximately 1.4 kg
Dimensions (W x H x D)
214 x 68 x 124 mm = 8.4 x 2.6 x 4.8 inches
67
TECHNICAL DATA
Chapter 8
Volume increments
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 selection
00:01 – 99:59 h
Accuracy of set delivery rate
± 5 % according to IEC/EN 60601-2-24
Administration Set Change Interval
Pumping accuracy is maintained for a
minimum of 96 hours.
Max. Volume in case of single fault
condition
For incorrect dosages of 1.4 ml due to
malfunctions of the device the pump will
automatically shut off
Technical inspection (safety check)
Every 2 years
Rate increments
0.1 - 99.99 ml/h in increments of
0.01 ml/h
100.0 - 999.9 ml/h in increments of
0.1 ml/h
1000.0 - 1200 ml/h in increments of
1 ml/h
Multiple lines connected to one
patient port
Accuracy of bolus infusion
typically ± 5 % for a bolus volume > 1 ml
KVO rate
Delivery rate 10 ml/h: KVO rate 3 ml/h
Delivery rate < 10 ml/h: KVO rate 1 ml/h
Delivery rate < 1 ml/h: KVO rate =
programmed rate (default setting 0.1 ml/h)
Computer connection
for Service Program
USB connection in combination with
B. Braun interface lead CAN SP
(8713230) including electrical
insulation. Please pay attention to
safety notices.
The Infusomat® Space Volumetric
Infusion pump includes an ultrasonic air
detection sensor that is used to detect
air in the disposable set. Per the
requirements of the IEC 60601-2-24
(2nd Ed. 51.104 and 3rd Ed.
201.12.4.4.107) the software uses this
sensor to detect the accumulation of air
not to exceed 1 ml/15 minutes of any
air bubbles greater than or equal to
0.01 ml (10 uL). The air accumulating
Air detector
68
Connecting multiple infusion lines with
different flow rates may affect the rate
for all infusions past the point of
connection.
TECHNICAL DATA
Chapter 8
value may be set between 0.5 – 3.8
ml/hr in increments of 0.1 ml/hr during
configuration. In addition, the pump
also has a configurable single bubble
alarm that can be set between 0.02 –
0.3 ml in increments of 0.01 ml.
The pump display indicates if the alarm
is a Single bubble alarm or an
Accumulated Air alarm and stops the
infusion thus requiring intervention
from the user to address the alarm.
“Upstream sensor”
9 levels from -90 mmHg to -160 mmHg
(pressure reduction)
Occlusion alarm pressures
(downstream pressure)
Occlusion pressure
[mmHg]
Level 1
typ. 226
Level 5
typ. 563
Level 9
typ. 900
9 levels from 225mmHg to 900 mmHg
Time to occlusion alarm [min] at rate
[1 mL/h]
[25 mL/h]
[100 mL/h]
09:07
00:33
00:07
25:53
01:14
00:15
46:50
02:06
00:24
Alarm volume
Mechanical occlusion pressure limit
under fault conditions
Pump log
Max bolus
[mL]
0.0347
0.0987
0.1787
9 levels from 1 (59dBA) to 9 (74dBA)
Occlusion alarm pressure max. 1575 mmHg
(210 kPa).
Maximum posts occlusion bolus volume
2ml.
Logs are accessed via the service
program.
Pump logs include history log of 1000
past entires, alarm log, key stroke and
notes log. Refer to HiBaSed IFU for
more information.
Caution: If a wrench
is displayed and/or the yellow, red and blue
LEDs blink, then the pump is in the service mode and cannot be used on a
patient. The pump must then be checked by a service technician.
Note: The technical data stated in this Instructions for Use manual were
determined with the Infusomat® Space line (870 0036 SP). These technical data
can change when using different set configurations.
• Use only pressure proof and compatible disposable items (min. 2 bar/
1500 mm Hg) to avoid influencing performance data - which would result in
impairing patient safety.
69
TECHNICAL DATA
Chapter 8
• Use only compatible combinations of equipment, accessories, working parts
and disposables with luer lock connectors.
• The Infusomat Space System is unsafe to use in proximity to magnetic
resonance imaging (MRI) equipment.
• Only use combined with approved devices/accessories by the manufacturer,
otherwise this may lead to higher emission or reduced immunity.
Essential Performance for Infusion pumps
•
•
•
•
Infusion of liquids without variation of infusion rate
Pressure limitation as protection from the bursting of the infusion line
Protection from air-infusion
Protection against unintended bolus volumes and occlusion (added by IEC
60601-2-24)
• Alarm signal of high priority (added by IEC 60601-2-24)
Dosing families
Drug and rate units and the abbreviation for each as they appear on the pump
are the following:
gram
milli gram
micro gram
nano gram
unit
milli unit
kilo unit
million unit
milli equivalent
milli mole
kilo calorie
milli liter
kilo gram
meters squared
body surface area
minutes
hour
seconds
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
g
mg
mcg
ng
U
mU
kU
MU
mEq
mmol
kcal
ml
kg
m2
BSA
min
h
sec
The following table shows the drug/rate units and options available for administration
of medications using dosing/rate units in combination with patient metrics and time
units. Dosing units are derived by selecting any one unit from each column in any
combination (except where noted otherwise). The dosing units may be pre-set in the
Drub Library (refer to Chapter 1.2 ) or selected when using the Dose Rate Calculator
(refer to Chapter 2.2.4).
70
TECHNICAL DATA
Chapter 8
Drug Units Patient Units
Time Units
g
(none)
min
mg
kg
h
mEq
m2
24h
mmol
sec (bolus only)
U
milli U
kU*
MU*
kcal**
Rate Units
ml
(none)
per hour only
ml
kg
per hour only
* no m2 or per minute dosing
** no m2, per minute, or per hour dosing
The table below shows the conversion for the dosing units of the gram and units
families :
Gram family
106 ng
103 mcg
1 mg
10-3 g
Unit family
103 mU
1U
10-3 kU
10-6 MU
The following formula is used to calculate flow rate:
Infusion rate (ml/hr) = Dose/concentration x (patient weight or BSA)
71
TECHNICAL DATA
Chapter 8
Guidance and manufacturer’s declarartion on electromagnetic compatibility
Guidance and manufacturer’s declaration – electromagnetic emission
The Space System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Space System or any component should assure that it is used in such
an environment.
Emissions test
Compliance
Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
The Space System uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
If WLAN-Module is installed within Battery module
(8713182U) or WLAN USB Stick for SpaceCom
(8713185) is used RF energy is transmitted by the
Space System.
Refer to technical data of Battery-Pack SP with Wifi
IUF and/or SpaceStation and SpaceCom for details.
RF emissions
Class B (Note 2)
The Space System or any component is suitable for
use in all establishments, including domestic
establishments and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic
purposes.
CISPR 11
Harmonic
emissions
IEC 61000-3-2
applicable only for
SpaceStation
Class A
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3
Note 1: Maximum emissions are measured with a complete system (SpaceStation and components).
Note 2: If Class A equipment is attached to the Space System, the Space System will become Class
A too. This equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the
Space System or shielding the location.
72
TECHNICAL DATA
Chapter 8
Guidance and manufacturer’s declaration – electromagnetic immunity
The Space System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Space System or any component should assure that it is used in such
an environment.
Immunity
test
test level
IEC 60601-1-2
IEC 60601-2-24
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
according IEC
60601-4-2
contact
IEC 60601-1-2:
±6KV
IEC 60601-2-24:
±8KV
±6KV no disturbances
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30 %.
Electrostatic
transient / burst
according IEC
61000-4-4
air
IEC 60601-1-2:
±8KV
IEC 60601-2-24:
±15KV
± 2 kV for power
supply lines
±8KV stop with alarm
possible
±8KV no disturbances
±15KV stop with alarm
possible
±2KV
±1KV
A/C power quality should be
that of a typical commercial or
hospital environment.
± 1 kV for
input/output lines
Surge
according IEC
61000-4-5
differential mode
±1KV
±1KV
±2KV
A/C power quality should be
that of a typical commercial or
hospital environment.
common mode
±2KV
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
according IEC
61000-4-11
< 5 % UT
(>95 % dip in UT )
for 0,5 cycle
complies by use of
internal battery
A/C power quality should be
that of a typical commercial or
hospital environment. If the
user of the Space System
requires continued operation
during long time A/C power
interruptions, it is
recommended that the Space
System or component be
powered from an
uninterruptible power supply or
a battery.
400 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
40 % UT
(60 % dip in UT )
for 5 cycles
70 % UT
(30 % dip in UT )
for 25 cycles
< 5 % UT
(>95 % dip in UT )
for 5 sec
Power frequency
(50/60 Hz)
magnetic field
according IEC
61000-4-8
<5% UT
for 5 s
(>95% dip)
3 A/m
Note: Different test values of IEC 60601-2-24 are marked in the table. At the test values no
dangerous disturbances occurred at the lower test values of IEC 60601-1-2.
73
TECHNICAL DATA
Chapter 8
Guidance and manufacturer’s declaration – electromagnetic immunity
The Space System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Space System or any component should assure that it is used in such
an environment.
Immunity test
test level
IEC 60601-1-2
IEC 60601-2-24
Compliance
level
Electromagnetic
environment - guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Space System or it’s components,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended
separation distance
radiated
electromagnetic
RF fields
according
IEC 61000-4-6
IEC 60601-1-2:
3 Veff normal and
10Veff in ISM
frequency band
IEC 60601-2-24:
10 Veff
150KHz to 80MHz
radiated
electromagnetic
RF fields
according
IEC 61000-4-3
10 V/m
80 MHz to 2,5 GHz
d = 1,2 P
Field strengths should be less then
10V/m
10Veff
150KHz to 80MHz
d = 1,2 P
80 MHz to 800 MHz
10 V/m
80 MHz to 3 GHz
d = 2,3 P
800 MHz to 2,5GHz
where p is the maximum output
power rating of the transmitter in
watts (W) according to the
transmit-ter manufacturer and d is
the rec-ommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
NOTE 3: See next page.
74
TECHNICAL DATA
Chapter 8
NOTE 3: Different test values of IEC 60601-2-24 are marked in the table. At these test values no
dangerous disturbances are allowed while at the lower test values of IEC 60601-1-2. Field strengths
from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
SpaceSystem is used exceeds the applicable RF compliance level above, the Space System should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Space System.
The Space System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Space System or component can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Space System as recommended below,
according to the maxi-mum output power of the communications equipment
rated power of the
ratio transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz bis 80 MHz
1,2P
80 MHz bis 800 MHz
1,2P
800 MHz bis 2,5 GHz
2,3P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,27
12
12
23
100
NOTE 1: For transmitters rated at a maximum power output not listed above, the recommended
separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where (P) is the maximum output power rating of the transmit-ter in watts (W)
according to the transmitter manufacturer.
NOTE 2: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the frequency range 0.15 MHz to 2.5 GHz to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently brought into
patient areas.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
75
WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 9
WARRANTY / TRAINING / TSC* / SERVICE /
DISINFECTING / DISPOSAL
B. Braun is the legal 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. IEC 60364 "Electrical installations of
buildings 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
confirms that this
medical product
complies with the
“Council Directive
on Medical Devices
93/42/EEC” dated
14th Junde 1993.
B. Braun
Melsungen AG
Warranty
B. Braun provides 12 months warranty, from the date of delivery, for every
Infusomat® Space pump and for every Battery-Pack SP. This covers repair or
replacement of parts damaged as a result of design/manufacturing errors or
material defects. Modifications or repairs to the unit undertaken by the
user/operator or by third parties invalidate the warranty.
The warranty does not cover the following:
Elimination of faults attributable to incorrect/unauthorized handling, or to
normal wear and tear.
Defective rechargeable battery packs can be returned to B. Braun for disposal.
Training
B. Braun offers a training for version X86U. 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 by B. Braun trained
personnel.
76
WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 9
Cleaning and Disinfecting
Caution: Before cleaning and disinfecting the pump, always disconnect
the pump from the patient, switch off the device and disconnect pump from A/C
power outlet and other devices (e.g. staff call).
Clean all external surfaces using a clean, soft, lint-free cloth dampened with a
mild cleaning solution of soapy water. Make sure to remove any visible residue
from all surfaces prior to disinfecting. The housing of Infusomat Space , the line
guide cover and the IV line guiding areas may be disinfected with EPA registered
hospital disinfectants containing 1-propanol, isopropyl alcohol, ethanol or
didecyl dimethyl ammonium chloride. Do not spray disinfectants directly on the
pump, use a soft, low lint cloth dampened but not saturated with product. After
cleaning and disinfecting allow device to dry for at least 20 minutes prior to
use.
Note: To clean and disinfect the peristaltic fingers and membrane, the line guide
cover can be removed using a pointed object (ballpoint pen) inserted in the
lower right corner. Clean cover and peristaltic fingers and membrane using a
clean, soft, lint-free cloth dampened with a mild cleaning solution of soapy
water. The line guide cover may be cleaned under running water after it is
removed from the pump. Disinfect line guide cover, peristaltic fingers and
membrame following same procedure as stated above.
Caution: Do not touch the peristaltic fingers and membrane area of
pump with sharp object.
When reinserting the line guide cover, make sure that it is not damaged and
that it audibly locks in place.
Note: Do not use chloride disinfectant products (bleach).
line guide cover
77
WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 9
peristaltic fingers and membrane
Note: Keep instrument upright and do not allow any part of instrument to
become saturated with or submersed in fluid during cleaning operation.
Do not allow moisture or detergents to come into contact with the electrical
connections of the device (P2 or P3 connectors) or any device openings. To
reduce the likelihood of moisture ingress into the electrical connectors, the P2
connector of a power supply or combi cable may be used to cover the
connections during cleaning operations. Ensure that any connectors used to
cover are not connected to a wall outlet or other electrical source. Once the
cleaning has been completed, remove the connector and inspect all connectors
for residual moisture and evidence of damage or breakdown to the plating on
the connectors. Allow any residual moisture to evaporate before plugging the
device into a wall outlet. Replace any connectors which exhibit damage or evidence of plating breakdown prior to returning the device to
service. Utilize electrical contact cleaner that does not react with plastics to
remove any deposits of material which may be present inside the electrical
connectors as required.
Caution: Do not allow liquids to enter into or come into contact with
any openings or electrical connections on the pump or power supply.
Fluid exposure in these areas may result in the risk of short circuit,
corrosion or breakdown of sensitive electrical components, and/or
electrical shock. If fluid exposure occurs, the device should be swapped
out with another device in a manner that presents minimal interruption
to patient care. The device should remain unplugged until it can be
inspected by a trained technician for any evidence of damage and/or
residual moisture which may impair the function of the device.
Caution: Do not touch line guide cover or peristalitic pumping area of
pump with sharp object.
When reinserting the line guide cover, make sure that it is not damaged and
that it audibly locks in place.
Note: The use of unappoved cleaners and failure to follow the disinfection procedures and the manufacturer's recommended dilutions can result in an instrument malfunction or product damage and could void the warranty.
78
WARRANTY / TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 9
Disposal
The pumps as well as battery packs can be returned to B. Braun for disposal.
Separate disposal is required for electrical and electronic
equipment (2002/96/EC)
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 B. Braun customer service or your local
representative service.
The device should be tested for proper functioning before initial use.
Included in Delivery
Infusomat® Space, Battery-Pack SP (with or without Wifi) and Instructions for
Use.
79
OPTIONAL SPACE ACCESSORIES
Chapter 10
O P T I O N A L S PA C E A C C E S S O R I E S
SpaceStation (8713140U)
Station that can hold for up to four B. Braun Space pumps. Refer to
SpaceStation user manual for operating instructions. For further information
contact your B. Braun Representative or call B. Braun Customer Service at
1-800-627-7867.
SpaceStation with SpaceCom (8713142U)
SpaceStation with data communication capabilities. Refer to SpaceStation user
manual for operating instructions.
SpaceCover Comfort (8713145U)
The SpaceCover Comfort, which attaches to the top of the SpaceStation,
includes a handle, central alarm management and alarm LEDs.
PoleClamp SP (8713130)
A maximum of three B. Braun Space pumps can be stacked together when used
with the PoleClamp SP. For detailed instructions on secure fixation of the
PoleClamp SP please refer to "Overview Infusomat® Space" and "Patient Safety".
Space Pole Clamp (speed clamp) (8713131)
Incorporates "speed clamp" for faster attaching/removing from IV Pole.
A maximum of three B. Braun Space pumps can be stacked together when used
with the Space Pole Clamp. For detailed instructions please refer to the
"Overview Infusomat® Space" and "Patient Safety."
Power Supply SP (8713112D)
The Power Supply SP can supply power for a single pump.
1.) Connect P2 plug of Power Supply SP with P2 socket on back of pump
(ensure that plug “clicks”).
2.) Push power plug into wall outlet.
Note: To disconnect plug from pump, firmly grasp the connector and pull
straight out. Do not twist or bend the cord or connector.
80
OPTIONAL SPACE ACCESSORIES
Chapter 10
Caution: Do not pull on cord to remove connector.
A maximum of three plugs can be stacked upon each other in P2 socket.
Technical Data: 100 – 240V AC~, 50/60 Hz, 0,4-0,2A
Combi Lead SP 12 V (8713133)
The Combi Lead SP can connect up to three pumps. All pumps can then be
operated by one Power Supply SP.
1.) Connect P2 plug of the Combi Lead SP 12 V with the P2 socket on the
back of the pump.
2.) Connect P2 plug of Power Supply SP with Combi Lead SP.
3.) Push plug of Power Supply SP into the wall outlet.
Note: A maximum of three plugs can be stacked upon each other in P2 socket.
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.
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.
Caution: Plug into vehicle charger and connect to pump. Do not
connect pump to patient if vehicle battery/generator is powering on.
Short Stand SP (8713135)
The Short Stand SP may be used to hang an infusion container above the pump
in place of a standing IV pole.
1.) Push the PoleClamp on the pump.
2.) Plug the short stand into the aperture on the PoleClamp; make sure
that it audibly locks in.
3.) To remove the short stand press the button where stand attaches to
pole clamp.
Note: Use only one infusion bag with max. 1000ml on the short stand.
81
OPTIONAL SPACE ACCESSORIES
Chapter 10
Note: Insure pump is properly secured before attaching fluid bag to short stand
and connecting to patient to assure pump cannot fall and harm patient.
Battery-Pack SP with Wireless (Li-Ion) (8713182U)
For further information on the Battery Pack with wireless (Li-Ion), see chapter
6.3 "Battery Pack SP with WiFi".
Battery-Pack SP without Wireless (NiMH) (8713180A)
For further information on the Battery Pack without wireless (NiMH), see chapter 6.1 "Battery Maintenance".
Interface Lead CAN SP (8713230)
Interface Lead CAN SP is needed in order to set up a connection between the
SpaceStation and /or pump and the computer to use the service program
(HiBaSed).
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 USB port as described in the
HiBaSed 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.
Note: A maximum of three plugs can be stacked upon each other in socket P2.
Connection Lead for Staff Call SP (8713232)
To connect the Infusomat® Space to a staff call system, use the Connection
Lead for Staff Call SP.
Note: Test staff call signalling each time new pump connection is established.
The Infusomat® Space offers three different staff call operating modes. They are
displayed in the signalling scheme below. Consider the functioning of the staff
call in the hospital when choosing an operating mode. Choose the operating
mode via the service program.
82
OPTIONAL SPACE ACCESSORIES
Chapter 10
turned off
static
without
OffAlarm*)
Alarm
dynamic
without
Off–Alarm
Alarm
dynamic
with
Off-Alarm
Alarm
turned on
turned off
Operating Alarm
Operation
1 sec
Operation
1 sec
1 sec
Operation
*) in the static mode without Off-Alarm, the staff call can be surpressed with k
Caution: The user should respond to the local pump alarms as well.
Note: A maximum of three plugs can be stacked upon each other in P2 socket.
Technical Data
Alarm
Operation
Connecting Wire
white and green
white and brown
disconnected
connected
connected
disconnected
Polarity of connection is arbitrary:
max. 24 V / 0.5 A / 12 VA
83
ORDERING
Art. No.
B. Braun Infusomat® Space (100 - 240 V) +
Battery-Pack SP with Wifi (Li-Ion) ..........................................................8713051U
B. Braun Infusomat® Space (100 - 240 V) +
Battery-Pack SP without Wifi (NiMH) ....................................................8713052U
Recommended accessories for the B. Braun Infusomat® Space:
SpaceStation........................................................................................................8713140U
SpaceStation with SpaceCom .......................................................................8713142U
SpaceCover Comfort..........................................................................................8713145U
Pole Clamp SP......................................................................................................8713130
Space Pole Clamp (speed clamp)...................................................................8713131
Power Supply SP (US Plug) ............................................................................8713112D
Combi Lead SP 12 V..........................................................................................8713133
Short Stand SP....................................................................................................8713135
Battery-Pack SP without Wifi (NiMH).........................................................8713180A
Battery-Pack SP with Wifi (Li-Ion)..................................................... ..........8713182U
Interface Lead CAN SP .................................................................................... 8713230
Connection Lead for Staff Call SP.................................................................8713232
Connection Lead SP (12 V)..............................................................................8713231
Interface Lead RS232 SP..................................................................................8713234
Infusomat® Space Lines/Sets – Product families:
•
•
•
•
•
84
15 Drop Set
60 Drop Set
Blood Set
Epidural Set
Filtered Set
Technical Support
If the pump fails to respond to the operating or troubleshooting procedures listed in
this manual and the cause cannot be determined, discontinue use and forward it to an
authorized B. Braun Service Center.
Should it be necessary to return the pump for repair, contact Technical Support at
B. Braun Customer Service at (800) 627-PUMP. A Returned Materials Authorization
number will be provided. Carefully pack the pump (preferably in the original
packing), and ship it prepaid to the address below. B. Braun cannot assume any
responsibility for loss or damage to returned instruments while they are in transit.
Service and product performance information, operation training, service training, and
service manuals may be obtained from the manufacturer by contacting:
B. Braun Medical Inc.
1601 Wallace Drive, Suite 150
Carrollton, TX 75006
Attn: Service Manager
or call (800) 627-PUMP
Product complaints may be sent to the Quality Assurance Manager at the above
address.
With each complaint, please include:
•
•
•
•
•
•
•
•
•
•
•
the pump’s serial number and software revision,
a description of the difficulty experienced,
the pressure limit setting,
the rate/dose setting,
the initial volume(s) to be infused (VTBI),
the type of fluid(s),
the amount of time between the start of the infusion and the time the
difficulty was noticed,
the message displayed at the time the difficulty occurred,
the catalog and lot number of the set(s) in use,
the diagnostic code (if applicable), and
any other information which might aid in the investigation of the complaint.
Authorization to return products must be received from B. Braun prior to shipment.
Please contact Customer Service at the above phone number for a Returned
Materials Authorization Number.
Clinical Support
The customer may speak with a Registered Nurse for clarification of operating
instructions or clinical applications for the Space pump, etc.
A (Clinical Support Specialist) Nurse Consultant may be reached at (800) 854-6851.
85
Manufactured by
B. Braun Melsungen AG
34209 Melsungen
Germany
Tel +49 (0) 56 61 71-0
38911910 • I0045700201
0815
Distributed by
B. Braun Medical Inc.
824 12th Avenue Bethlehem,
PA 18018-3524 USA
www.bbraunusa.com
Clinical and technical support for USA:
1-800-854-6851
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