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Perfusor Space Syringepump Nextgenerationsoftwareu

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0% found this document useful (0 votes)
261 views

Perfusor Space Syringepump Nextgenerationsoftwareu

Uploaded by

E- Med
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 94

Perfusor® 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 588U

38910389U_Perfusor Space_US_230721 LLD Order 5404


CONTENTS

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


Symbols on Product ...........................................................................................................................9
Patient Safety ..................................................................................................................................11
Menu Structure / Navigation........................................................................................................16
Optimizing Performance: Start Up Time, Flow Accuracy and Time to Occlusion .........18
Entering Values .................................................................................................................................21
Chapter 1 Operation .................................................................................................................24
1.1 Inserting Syringe and Priming Line in Pump.....................................................................24
1.2 Drug Library.................................................................................................................................26
1.3 Programming a PRIMary Infusion in the Drug Library ...................................................31
1.4 Programming an Intermittent Dose Over Time Infusion................................................36
1.5 Programming a Loading Dose in the Drug Library...........................................................36
1.6 Programming a Bolus with Dose and Time in the Drug Library ..................................38
1.7 Manual Bolus ..............................................................................................................................40
1.8 Changing Care Unit...................................................................................................................40
1.9 Changing Display While Pump is Running.........................................................................41
1.10 Basic Infusion (programming the pump outside of the drug library) ........................41
1.11 Syringe Change and New Therapy Start.............................................................................43
1.12 End of Infusion ...........................................................................................................................44
1.13 Standby Mode.............................................................................................................................44
Chapter 2* Pump Menus...........................................................................................................45
2.1 Infusion Totals ............................................................................................................................45
2.2 Options..........................................................................................................................................46
2.2.1 Downstream Occlusion Pressure ..............................................................................46
2.2.2 Alarm Volume.................................................................................................................46
2.2.3 Dose Rate Calculator ...................................................................................................47
2.2.4 Data Lock.........................................................................................................................49
2.2.5 KVO Mode .......................................................................................................................50
2.2.6 Contrast / Display Light / Keypad Light .................................................................50
2.2.7 Bolus Rate .......................................................................................................................51
2.2.8 Date / Time......................................................................................................................51
2.2.9 Macro Mode ...................................................................................................................51
2.3.10 Wireless Activation.......................................................................................................51
2.3 Status Menu................................................................................................................................52
Chapter 3 Alarms.......................................................................................................................53
3.1 Device Alarms .............................................................................................................................53
3.2 Pre-Alarms and Operating Alarms........................................................................................53
3.3 Reminder Alarms........................................................................................................................55
3.4 Alarm Prompts............................................................................................................................56
Chapter 4 Wireless Drug Library Upload ............................................................................57
Chapter 5 AutoProgramming and Barcoding....................................................................59
Chapter 6 Battery Operation and Maintenance...............................................................61
6.1 General..........................................................................................................................................61
6.2 Safety Instructions ....................................................................................................................62
6.3 Battery with WiFi ......................................................................................................................64
Chapter 7 Syringes for Use with Perfusor® Space...........................................................65
7.1 Syringe Flow Rates and Infusion Volumes .........................................................................65
7.2 Time to Occlusion ......................................................................................................................67
*The availability of
7.3 Administration Sets for Use with Perfusor® Space .........................................................69
the listed features
depends on the Chapter 8 Start Up Graphs and Trumpet Curves..............................................................71
configuration of Chapter 9 Technical Data........................................................................................................72
the pump's Chapter 10 Training / TSC** / Service / Disinfecting / Disposal ....................................87
biomed file. Chapter 11 Optional Space Accessories................................................................................89
**Technical Safety Ordering ..............................................................................................................................................92
Check.
2
PERFUSOR® SPACE OVERVIEW

P E R F U S O R ® S PA C E O V E R V I E W

Follow on screen prompts using arrow keys to navigate Press to clear values in Drive head with claw
menus, select parameters, change values and respond to programming screens or to mechanism to hold the
on screen prompts. go back one screen. syringe plunger plate.

q c
Protective Cap
Press to Press to Note:
Yellow LED: Pre-alarm or reminder alarm initiate turn pump Emergency
Green or Red LED: or bolus. on/off and release button on
initiate outside of drive
B
n
Green LED: Infusing
Red LED: Operating or Device Alarm standby head is located
mode. below protective
Blue LED: Initiating connection to wireless cap. Replace
battery or SpaceStation
o protective cap
after pressing.

k m f
S
Press to select and/or Press to initiate Press to Start/Stop The syringe holder locks the
confirm values/settings/ autoprogramming the infusion. syringe in position. To remove the
alarms/messages. orders when syringe, pull and turn to the right.
prompted. The drive head automatically
retracts.

Cover of Battery Compartment

Port P3 for future options Port P2 for power supply, SpaceStation, combi lead
and additional accessory leads (staff call, service plug)
3
PERFUSOR® SPACE OVERVIEW

Pole Clamp SP (model 8713130)

Rotation lever 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 from IV pole. For vertical positioning
of Pole Clamp, push rotation lever down
and rotate pump either way until lever
clicks into notch. Push lever for rotation.
W Caution: Do not lean on pump when
Pole clamp attached to pole.
release button A maximum of three B. Braun Space
pumps can be stacked together when
used with the PoleClamp SP. Rotating
position while infusing may result in
temporary increase in flow rate or bolus.

Pole clamp handle Attaching Pump to Pole Clamp


Line up slots on top sides of pump with
Pole clamp grooves of Pole Clamp and slide pump into
release button
Pole Clamp until locking mechanism clicks.
To remove, simultaneously press release
Pump slots button on frame and push handle down
while pulling pump out from pole clamp.

Locking Devices Together


A maximum of three pumps (Infusomat®
Space or Perfusor® Space) may be
interlocked on a single pole clamp.
W Caution: Avoid external mechanical
Green locking action.
button 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.
4
PERFUSOR® SPACE OVERVIEW

The pump is now securely attached to Pole


Clamp.
W Caution: Do not position the pump
unit over the patient.

Underside view W Cautions:


Clamp grids • DO NOT use any Pole Clamp that
shows signs of damage.
• DO NOT use Pole Clamp with
missing clamp grids.

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.

5
PERFUSOR® 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.

The pump is now securely attached to the


pole clamp.
W Caution: Do not position the pump
unit over the patient.

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
Green locking clicks and the green buttons are aligned
button 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.
W 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.

6
PERFUSOR® SPACE OVERVIEW

➀ Vertical Positioning
Simply turn the pump either way until it
clicks into notch at 90 degree/vertical
position.
W Caution: Rotating position while
infusing may result in temporary
increase in flow rate bolus.

➁ ➂

W Caution: Do not lean on pump when


attached to pole!
A maximum of three B. Braun Space
pumps can be stacked together when
used with the Space Pole Clamp (speed
clamp).

7
PERFUSOR® SPACE OVERVIEW

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.

W Caution: DO NOT use any Pole Clamp


that shows signs of damage.

8
SYMBOLS ON PRODUCT

SYMBOLS ON PRODUCT
IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance
Symbol Title Reference- Explanatory text or meaning
number
Follow Instructions D.2-10 Mandatory action: See Instructions for Use.
for Use.

General warning sign D.2-2 To signify a general warning

Defibrillation-proof D.1-27 To identify a defibrillation-proof type CF applied


type CF applied part part.

Class II equipment D.1-9 To identify equipment meeting the safety


requirements specified for Class II equipment.

Direct current D.1-4 To indicate on the rating plate that the


equipment is suitable for direct current only.

ISO 15223-1, Medical Devices - Symbols to be used with medical device labels, labelling,
and information to be supplied - Part 1: General requirements
Symbol Title Reference- Explanatory text or meaning
number
Temperature limit 5.3.7 Indicates the temperature limits to which the
medical device can be safely exposed.

Humidity limitation 5.3.8 Indicates the range of humidity to which the


medical device can be safely exposed.

Atmospheric 5.3.9 Indicates the range of atmospheric pressure to


pressure limitation which the medical device can be safely exposed.

Manufacturer 5.1.1 Indicates the medical device manufacturer.

Date of manufacture 5.1.3 Indicates the date when the medical device was
manufactured.

9
SYMBOLS ON PRODUCT

ISO 15223-1, Medical Devices - Symbols to be used with medical device labels, labelling,
and information to be supplied - Part 1: General requirements
Symbol Title Reference- Explanatory text or meaning
number
Batch code 5.1.5 Indicates the manufacturer's batch code so that
LOT the batch or lot can be identified.

Catalog number 5.1.6 Indicates the manufacturer's catalog number so


REF that the medical device can be identified.

Serial number 5.1.7 Indicates the manufacturer's serial number so


SN that a specific medical device can be identified.

Consult Instructions 5.4.3 Indicates the need for the user to consult the
for Use Instructions for Use.

Caution 5.4.4 Indicates the need for the user to consult the
w Instructions for Use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself.

IEC TR 60878: Technical Report Graphical symbols for electrical equipment in medical practice
Symbol Title Reference- Explanatory text or meaning
number
Non-ionizing electro- 5140 To indicate generally elevated, potentially
magnetic radiation hazardous, levels of non-ionizing radiation, or
to indicate equipment or systems e.g. in the
medical electrical area that include RF
transmitters or that intentionally apply RF
electromagnetic energy for diagnosis or treatment.
MR Unsafe 62570- To identify an item which poses unacceptable
7.3.3 risks to the patient, medical staff or other
persons within the MR environment.
MR Conditional 62570- To identify an item which poses no unacceptable
7.3.2 risks within defined conditions to the patient,
medical staff or other persons within the MR
environment. *see Warning statement regarding MR
information in Patient Safety section for further information.

List of abbreviations
KVO = Keep Vein Open VTBI = Volume To Be Infused
LED = Light-Emitting Diode MR = Magnetic Resonance Imaging
(indicator lamps) BSA = Body Surface Area
EHR = Electronic Health Record Li-Ion = Lithium Ion
10
PATIENT SAFETY

PAT I E N T S A F E T Y
Indications for Use
The Perfusor® Space Syringe Infusion Pump System is intended for use on
Read Instructions adults, pediatrics, and neonates for the intermittent or continuous delivery of
for Use prior to parenteral fluids, enteral fluids, medications, blood and blood products through
operation. The clinically accepted routes of administration. These routes include intravenous,
infusion device intra-arterial, subcutaneous, epidural and enteral.
should only be
used by trained The Perfusor® Space Syringe Infusion Pump System is intended to be used by
healthcare trained healthcare professionals in healthcare facilities and for medical ground
professionals. and/or air transport situations.

Dedicated Syringes
The Perfusor® Space Infusion Pump is intended to be used with only dedicated
syringes labeled for the different routes of administration.

Warnings
• The initial training of the Perfusor® 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.
• Prior to administration, visibly inspect the pump for damage, missing parts or
contamination and check audible and visible alarms during self-test.
• Ensure syringe sizes and models are compatible with the Perfusor® Space
(refer to Chapter 7). Use of incompatible syringes can cause improper pump
operation resulting in inaccurate fluid delivery, insufficient occlusion
(blockage) sensing, and other potential problems.
• Use the smallest compatible syringe size necessary to deliver the fluid or
medication; this is especially important when infusing high risk or
life-sustaining medications at low infusion rates (e.g., less than 5 mL per hr,
and especially flow rates less than 0.5 mL per hr). Using a larger syringe
when infusing at low rates can lead to inadequate syringe pump performance
including delivery inaccuracies, delay of therapy and delayed generation of
occlusion alarms. This is due to the increased friction and compliance of the
syringe plunger tip with larger syringes.
• Electronically prime the syringe pump system before starting an infusion
or after replacing a syringe with a replacement syringe.
A Verify the fluid flow to the patient is OFF, and if enabled, use the prime
function on the syringe pump to remove any mechanical slack in the system.
A Using the syringe pump’s prime feature engages the mechanical
components of the pump and decreases the syringe’s friction and
compliance (i.e. stiffness) to minimize startup delays and delivery
inaccuracies, especially at low infusion rates. 11
PATIENT SAFETY

A Failure to use the prime feature on the syringe pump after every syringe
change and/or tubing change can significantly delay the infusion delivery
startup time and lead to delivery inaccuracies.
• During priming and bolusing the pressure limits are set to the maximum level.
• Only connect to patient once the syringe has been correctly inserted and the
line completely primed (See Chapter 1.1). Disconnect from patient during
syringe change to prevent unintended delivery.
• During programming and prior to starting an infusion, verify that the syringe
size and model on the syringe pump’s display screen matches the syringe size
and model loaded onto the syringe pump.
• Use syringes approved for Perfusor Space and only use luer lock fittings to
connect IV line to syringe. During administration of epidural or enteral
solutions only use syringes and tubing approved for epidural or enteral
administration (See Chapter 7).
• Ideally, the syringe pump should be level with the distal tip of the catheter
(e.g. the site of fluid delivery; if accessing a central line the syringe pump
should be at the level of the patient’s heart). If the pump height is raised
relative to the distal tip of the catheter (e.g. during patient transport), the
increase in height of the syringe pump can result in a temporary increase in
fluid delivery or bolus until the flow rate stabilizes. Alternatively, if the pump
is lowered relative to the distal tip of the catheter, the decrease in height of
the syringe pump may result in a decrease in delivery or under-infusion until
the flow rate stabilizes. Rotating the pump between the horizontal and
vertical position while infusing may also result in temporary increase in fluid
delivery or bolus.
• To minimize the amount of time it takes the pump to recognize an occlusion
(blockage) and generate an alarm while infusing at low rates (e.g., less than
5 mL per hr, and especially flow rates less than 0.5 mL per hr):
A Consider the plunger force or occlusion pressure threshold setting and
adjust it, as necessary. The lower the plunger force setting or occlusion
pressure threshold setting, the shorter the occlusion detection time.
However, when infusing viscous or thick fluids (e.g., lipids) the plunger
force or occlusion pressure threshold setting may need to be adjusted to
reduce false alarms. See Chapter 2.2.1 for further detail.
A Use the smallest compatible syringe size necessary to deliver the fluid or
medication. This minimizes the amount of friction and compliance (i.e.,
stiffness) of the syringe plunger tip. Because syringe pumps infuse fluids
by precisely controlling the plunger, smaller syringes provide more precise
fluid delivery and faster occlusion detection than larger syringes.
A Use the prime feature on the pump when inserting a new syringe and
changing a syringe and/or tubing.

12
PATIENT SAFETY

A Use accessory devices, which have the smallest internal volume or


deadspace (e.g., microbore tubing when infusing at low rates, shorter
length of tubing, etc.). See Chapter 9, page 74 for further detail.
• When addressing or clearing an occlusion:
A Ensure the fluid flow to the patient is OFF to prevent administering an
unintended bolus. An occlusion may pressurize the infusion tubing and
syringe, which can result in an unintended bolus of drug when the
occlusion is cleared. In order to prevent this additional bolus, disconnect
the tubing, or relieve the excess pressure through a stopcock, if present.
The healthcare professional should weigh the relative risks of
disconnection with the risks of unintended bolus of drug.
A Be aware that using larger size syringes on a high plunger force setting
may produce a larger post occlusion bolus due to excessive syringe
plunger tip compliance.
• Not to be used adjacent to and/or stacked with other equipment except
B. Braun Space devices.
• Compare the displayed value on the pump with the entered value prior to
starting infusion.
• Compare medication order to programming parameters including drug name,
concentration and dose prior to starting infusion.
• Check default values pre-populated from drug library with physician order
prior to starting infusion.
• The default values and limits of the drug library provide a safety net for
programming and are not intended to be used to define treatment.
• Consider additional monitoring which may be required when using high risk
medications.
• Consider plausibility of calculated flow rate for infusions programmed with
BSA to assist in determining accuracy of BSA value.
• If the pump is dropped or is exposed to force, it must be checked by the
service department.
• Do not apply force or hold the pump by the drive head while infusing or
during transport.
• 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 exchanged 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.
13
PATIENT SAFETY

• If staff call is used, check the equipment once after connecting the pump to
ensure staff call is working.

Cautions
• Use compatible components which have the smallest internal volume or
“deadspace” to minimize residual volumes between the syringe and the
patient when administering medications or fluids at low infusion rates (e.g.
less than 5 mL per hr, and especially flow rates less than 0.5 mL per hr). This
reduces the amount of time it takes for fluid to reach the patient, maintains
delivery accuracy, and reduces occlusion detection times. For example:
A Tubing internal diameter: Small bore or microbore tubing is recommended
when infusing at low rates
A Tubing length: Tubing length should be minimized, when possible
A Filters: Internal volume (deadspace) of in-line filters should be minimized
A Connection sites: The number of connection sites such as stopcocks and
Y-sites should be limited, and high risk or life-sustaining solutions should
be connected as close to the intravenous access site as possible.
• Avoid use of manifolds with ports containing high pressure valves. High
pressure valves require additional pressure (e.g. 50-200 mmHg) to open and
allow fluid flow. These high pressure valves may cause a significant delay in
therapy followed by a sudden bolus once the valve is opened, particularly at
low infusion rates (e.g. less than 5 mL per hr, and especially flow rates less
than 0.5 mL per hr)
• Manually prime the syringe and tubing to remove all air, before connecting
to the pump unless using the priming feature on the pump to remove air
from the tubing (See Chapter 1.1)
• If using multiple syringe pumps and it is not clinically feasible to have all
pumps level with the distal tip of the catheter (or the site of fluid delivery),
place the high risk or life-sustaining medications as close to level with the
distal tip of the catheter as possible. When infusing multiple high risk or life
sustaining medications, consider placing the ones infusing at the lowest
rates as close to the level with the distal tip of the catheter as possible.
• Minimize the height difference between the pump and the patient and avoid
changes in the height of the pump (e.g., during transport of critically ill
patients) to prevent unintended fluctuations in the flow rate
• Ensure the unit is properly positioned and secured (See Perfusor® Space
Overview). Do not position pump above patient or in a position where a
patient could be harmed if the pump should fall.
• Ensure the infusion line is free of kinks.
• Do not operate in the presence of flammable anesthetics or in a hyperbaric
oxygen chamber.
14
PATIENT SAFETY

• The Perfusor Space or the Space System and its accessories should not be
used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, the Perfusor Space or the Space System and its accessories
should be observed to verify normal operation in the configuration in which
it will be used.
• Sporadic device alarms may occur when the pump is exposed to strong
RF electromagnetic fields in the 860 – 960 MHz range. Pump stoppage
associated with an “alarm of high priority” is consistent with the safety
concept of the device, and is remedied in this case by the user resuming the
current operation or by restarting the pump.

Safety Standards
Perfusor® 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 60601-1-2:2007 and IEC 60601-2-24: 2012 are maintained. If the
equipment is operated in the vicinity of other equipment which may cause
high levels of interference (e.g. HF surgical equipment, nuclear spin
tomography units, mobile telephones etc.), this equipment may be disturbed.
Maintain the protective distances recommended by the manufacturers of
these devices.
• During transport of patients the Perfusor® 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
temperature limits the Perfusor® Space needs to remain under room
temperature at least one hour before usage.
The Perfusor® Space Infusion Pump is unsafe when used as a
standalone device in proximity to magnetic resonance imaging
(MRI) equipment. The pumps, when within the SpaceStation
MRI, can be used conditionally in the MR environment when complying to the
SpaceStation MRI Instructions for Use. Do not remove the pump from the
SpaceStation MRI in proximity to MRI equipment.

15
MENU STRUCTURE / NAVIGATION

MENU STRUCTURE / NAVIGATION


Overview of Keys and Displays
o On/Off key K OK key
f
s Start/Stop key Q Keypad with arrows
b
n Bolus key m Initiation of Auto-programming
C Clear and/or back key 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 by
pressing u for yes or d for no. Pressing
yes recalls all parameters of the last
infusion prior to power off. The question
appears if configured in the service tool.

Parameters can be changed (e.g. rate in


mL/h) by opening the editor screen
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 top of the screen indicates
infusion mode and soft limit symbol.

Typical display during infusion:

Wireless Current Set pressure limit


pressure level
Infusion Connected to Power/Battery Status
mode

Scrolling arrows indicate pump is infusing


Soft limit indicator Set rate can be opened with l to edit
Drug name
Unit of drug delivery
Infusion status information
16
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
or u and will be displayed (e. g. Care
Unit, drug long name, time/ VTBI
remaining, drug concentration, total
volume, infused totals) 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 syringe must be removed to power the
pump off. Pump will go into stand-by if
the syringe is not removed.

17
OPTIMIZING PERFORMANCE: START UP TIME, FLOW ACCURACY AND TIME TO OCCLUSION

OPTIMIZING PERFORMANCE: START UP TIME,


FLOW ACCURACY AND TIME TO OCCLUSION

Optimization of the Perfusor Space syringe pump performance is dependent on


following several recommendations outlined below.
First, always use syringes approved for use with the Perfusor® Space (See Chapter 7)
and select the smallest syringe size for the volume and flow rate of fluid being
administered. Syringe size impacts start up time and time to occlusion as well as flow
variability at low rates. Post occlusion bolus volume may also be increased when a
large syringe is used at a low flow rate with a high occlusion limit setting.
Each syringe size has a recommended minimal flow rate (See Chapter 7.1 for table
with flow rates).
When a programmed rate falls below the recommendation for the inserted syringe, an
alert will be generated.

The alert allows for 3 possible actions:


• check settings for possible re-programming
• change to smaller syringe size
• override and start infusion
When titrating a running infusion, a similar alert will occur when the rate is below that
recommended for the syringe size.

The alert allows for 2 possible actions,


• override the alert and initiate the new flow rate
• go back to rate/dose editor and re-program

Second, insure proper syringe insertion and confirmation. Start up times are affected
by the compliance and friction of the syringe, each syringe brand and size has unique
values. Larger syringes have higher friction and compliance and therefore longer start
up times. It is important to properly insert the syringe (See Chapter 1.1 to insert and

18
OPTIMIZING PERFORMANCE: START UP TIME, FLOW ACCURACY AND TIME TO OCCLUSION

prime the syringe) and then confirm both the correct brand and size when inserting
the syringe as the pump software adjusts for the characteristics of each syringe.
Additionally, using the prime feature on the pump may enhance start up time.
Third, use small diameter tubing for low flow rates and minimize the length as well as
the number of additional components such as stop cocks and filters.
• Use compatible components (See Chapter 7.1) which have the smallest
internal volume or “deadspace” to minimize residual volumes between the
syringe and the patient when administering medications or fluids at low
infusion rates. This reduces the amount of time it takes the fluid to reach the
patient, maintains delivery accuracy, and reduces occlusion detection times.
For example:
A Tubing internal diameter: Small bore or microbore tubing is recommended
when infusing at low rates
A Tubing length: Tubing length should be minimized, when possible
A Filters: Internal volume (deadspace) of in-line filters should be minimized
A Connection sites: the number of connection sites such as stopcocks and
Y-sites should be limited, and high risk or life-sustaining solutions should
be connected as close to the intravenous access site as possible
A Avoid use of manifolds with ports containing high pressure valves. High
pressure valves require additional pressure (e.g. 50-200 mmHg) to open
and allow fluid flow and may result in a sudden bolus.
Fourth, set the occlusion limit (See Chapter 2.2.1 to set downstream pressure limit), at
the lowest setting for the infusion taking into consideration syringe size (smaller
syringes require higher infusion pressures), patient line type, flow rate, fluid viscosity,
and tubing characteristics (diameter, filters, length, etc.). Setting to the lowest
occlusion limit that does not produce nuisance alarms shortens time to occlusion
alarm and minimizes post occlusion bolus volumes (See Chapter 7.2 for time to
occlusion and post occlusion bolus volumes per syringe size, rate and pressure setting).
Post occlusion bolus occurs, in particular with larger syringes, when fluid volume builds
up or gets “stored” in the system and is infused when the occlusion is removed. The
Perfusor Space has software that minimizes post occlusion bolus by pulling back on
the syringe plunger to minimize the amount of the bolus. This does not totally
eliminate the bolus. For the maximum post occlusion bolus volume please refer to
Chapter 7.
Consider the plunger force or occlusion pressure threshold setting and adjust it, as
necessary. The lower the occlusion pressure threshold setting, the shorter the occlusion
detection time. However, when infusing viscous or thick fluids (e.g. lipids) the occlusion
pressure threshold setting may need to be adjusted to a higher setting to reduce false
alarms.

19
OPTIMIZING PERFORMANCE: START UP TIME, FLOW ACCURACY AND TIME TO OCCLUSION

Use the smallest compatible syringe size necessary to deliver the fluid or medication.
This minimizes the amount of friction and compliance (i.e. stiffness) of the syringe
plunger tip. Because syringe pumps infuse fluids by precisely controlling the plunger,
smaller syringes provide more precise fluid delivery than larger syringes and faster
occlusion detection.
A Use the prime feature on the pump when inserting a new syringe,
changing a syringe and/or tubing
• Use accessory devices which have the smallest internal volume or deadspace
(e.g. microbore tubing when infusing at low rates, shorter length of tubing,
etc.)
• When addressing or clearing an occlusion:
A Ensure the fluid flow to the patient is OFF to prevent administering an
unintended bolus. An occlusion may pressurize the infusion tubing and
syringe, which can result in an unintended bolus of drug when the
occlusion is cleared. In order to prevent this additional bolus, disconnect
the tubing, or relieve the excess pressure through a stopcock, if present.
The healthcare professional should weigh the relative risks of
disconnection with the risks of unintended bolus of drug.
A Be aware that using larger size syringes on a high plunger force setting
may produce a larger post occlusion bolus due to excessive syringe
plunger tip compliance.
Fifth, consider height and location of syringe pump system.
If the pump height is raised relative to the distal tip of the catheter (e.g.
during patient transport), the increase in height of the syringe pump can
result in a temporary increase in fluid delivery or bolus until the flow rate
stabilizes. Alternatively, if the pump is lowered relative to the distal tip of
the catheter, the decrease in height of the syringe pump may result in a
decrease in delivery or under-infusion until the flow rate stabilizes.

20
ENTERING VALUES

ENTERING VALUES
In order to enter and/or edit an infusion parameter, 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 u and d to move the cursor so
the desired numerical value to be changed is highlighted. Use l and r 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 u in the “ones” place 9 times
and then press r once to move the
cursor to the “tenths” decimal place and
pressing u 5 times.

Press 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 r and l keys to highlight desired number,
in this case the “ones” place.

To Titrate to another value, e.g. 11.5 press


d eight times to get 1.5

Then press l to move the cursor to the


“tens” place and press u once .

21
ENTERING VALUES

Arithmetic logic:
An alternative method for entering and titrating values uses arithmetic logic:

Pressing u one time in the “ones” place


increases the value to 10.5

Pressing d from the “ones” place


decreases the value to 9.5

Pressing 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 cases where an increase in value
would exceed a hard limit, the pump will display 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 l to move the cursor to the “tens” place.

Press 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.

22
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 d is pressed on the above screen, the pump displays the previous value i.e. 9.5.

If 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 k, the pump pre-fills the
programming editor field with the last
value programmed and confirmed
prior to the value that created the alert.

While in the editor function, Q and k


are used to define and confirm a value,
the c can be used to reset the value
to 0.

To exit the editor function, press c again. The value of the infusion parameter reverts to the last
confirmed value.

23
OPERATION
Chapter 1

OPERATION
1.1 Inserting Syringe and Priming Line in Pump
• Ensure that the pump is properly installed (see Perfusor® Space Overview).
Check the equipment for completeness and damages.
• 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.
• Observe B. Braun landing page and press k to enter infusion parameters followed
by syringe insertion, or press r for steps required to load syringe. Use r to
advance through animated syringe loading steps. After step 4, open the pump door
by pulling down.

W Caution: Close patient connection during syringe change.

24
OPERATION
Chapter 1

Pull the syringe holder, which is to


the immediate right of the pump
door, straight out and turn
completely to the right.

Insert the syringe with wings/flange


in the vertical position so that the
flange fits between the pump
housing and the green syringe guide.
, Graduations on syringe should be
,

facing forward and easily visible.

Close syringe holder by turning back


to left. Note that piston brake
engages to hold plunger in place
until drive head closes.

Confirm syringe brand by using u or d to select brand and k to confirm selection.

Confirm syringe size by using u or d to select size and l or k to confirm


selection. Drive head engages and moves to secure syringe once brand and size are
confirmed. Piston brake is released once drive head has secured syringe.

25
OPERATION
Chapter 1

• W Caution: Manually prime the syringe and tubing to remove all air before
connecting to the pump unless using the priming feature on the pump to
remove air from the tubing.
If priming is activated, press u to select yes to prime syringe and note prompt to
disconnect syringe 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.

• Connect 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. The question appears if configured in the
service tool.

1.2 Drug Library


The Perfusor® Space 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 subdivided 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, loading dose and bolus settings, and
26
OPERATION
Chapter 1

infusion type based on patient type or condition. Care Units allow drugs to have diffe-
rent settings based on location or classes of patients.
The maximum number of drug names in each drug library file may be limited based on
the number of Care Units, concentrations, and Patient Profiles that are utilized when
building the drug library.
• 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 or BSA.
• 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 values 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
the figure below, to indicate when infusion is within, below or above limits.

27
OPERATION
Chapter 1

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 within the upper soft limit =
The infusion is within the lower 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 =

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 for the syringe size
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.

28
OPERATION
Chapter 1

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 an 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.

When u is pressed again, 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.

29
OPERATION
Chapter 1

Example 2:
Drug with a lower hard limit of 0.2 g
Current value is 0.3 g

Pressing 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 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.

Example 3:
Pump maximum rate depends on syringe size, see syringe rate table in Chapter 7.
For this example the inserted syringe is 5 mL with a max rate of 200 mL/hr.
Current value 199 mL/hr

Pressing u once with the cursor in the hundreds column displays value of
200 mL/hr which is at but not above the hard limit.

30
OPERATION
Chapter 1

When 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 the
physician order.

1.3 Programming a PRIMary Infusion in the Drug Library


When the syringe has been loaded and the infusion line 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 syringe
by pressing k from this screen.

Note: When a previous infusion has been programmed on the pump, prompt
"Continue last infusion?" will be displayed with previous infusion information.

• Select the Care Unit using u and d to scroll through the list and press
l or k to make selection.

31
OPERATION
Chapter 1

Note: A basic infusion may be selected from this list. Basic infusions are addressed in
Chapter 1.10.

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 and confirm with l or k. If no profile is
set in the drug library, this step will be skipped.

• Select the drug category using Q and confirm with l 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
or use l and r to quickly skip through the alphabet in groups of 3 (i.e.
ABC-DEF) . Press l or k to select drug.

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 Chapter 1.8 for instructions on changing the Care
Unit while infusing.
• Choose drug concentration using u and d, press l 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 . Select with l or k.
Refer to Chapter 1.4 for instructions on Dose over Time therapy.

32
OPERATION
Chapter 1

• 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 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 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.

Note: If flow rate is too high for inserted syringe, prompt indicates value not possible
with current syringe. Upon confirming prompt with k the display returns to
editor for re-programming.

Note: Home symbol is displayed in upper left of home screen. Home screen may be
accessed from run screen by pressing c.
Note: Default values may be present when set in drug library. In this case the
editor screens do not appear. Confirm values and press s f to begin the
infusion or press l to edit default values. Observe green LED and arrows
moving right to left in upper right of display indicating infusion is
running.
33
OPERATION
Chapter 1

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 override soft limit.
Note: Change in soft limit symbol when overridden.

• 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.

34
OPERATION
Chapter 1

Note: The Perfusor® Space delivery rates are determined by the syringe size. When a
rate is set that exceeds the possible rate for the inserted syringe, the display will
indicate programming is not compatible with the syringe. 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 not required, pump
will continue to deliver until syringe end alarm unless VTBI or time are
entered which are less than syringe volume or time to completion at current
rate. Time will be calculated when VTBI is entered. When time is entered,
VTBI is calculated if rate/doserate has been programmed.
• When all parameters have been entered and confirmed with k, “Start”
appears in upper right of display.

• Press s
f 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 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.

35
OPERATION
Chapter 1

1.4 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. 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 in Chapter 1.3.
• Enter weight or BSA, as prompted, based on dose settings in drug library.
• Enter total dose and press k to confirm.

• 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 .
Note: The KVO and Bolus functions are disabled during Dose over Time.

1.5 Programming a Loading Dose in the Drug Library


The Perfusor® 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
36
OPERATION
Chapter 1

exiting and clearing the infusion by pressing the c and re-programming the drug
from the beginning.
To Program a loading dose:
• Press u to answer yes to loading dose prompt.

• Enter loading dose amount using q , confirm with k.

• Enter loading dose time using q , confirm with k.

Note: Soft and Hard limit alerts will be generated based on drug library settings.
• Press l to access doserate/rate editor to set continuous infusion.
• Enter doserate or rate for continuous infusion and confirm with k.

• VTBI or Time may be entered but are not required.


Note: "LD dos and Start" alternate in upper right corner of screen.

• Press s
f to begin infusion.
Note: The word LOAD is super-imposed on the run arrows.

37
OPERATION
Chapter 1

Note: The loading dose may be stopped at any time by pressing the sf. Press
f
s to deliver remaining loading dose. There will be nothing infusing until
Load Dose is resumed or canceled 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 s
f , the pump will prompt to deliver remaining loading dose.
Press u for yes, d for no.

Note: Once "No" is selected, it is no longer possible to recall the loading dose.

1.6 Programming a Bolus with Dose and Time in the


Drug Library
The Perfusor® Space allows for delivery of a programmed bolus for drugs which have
been set up in the drug library for bolus dosing.
• Press n
b.
• Select Program bolus dose and time.
Note: Drugs which do not have manual bolus enabled will skip this step.
Note: Bolus rate and volume is limited by syringe size. See Chapter 7.1

• Select dosing unit and confirm with k.

Note: Pump defaults to bolus units set in the drug library. If the bolus ordered is in
different units, press u or d to change units. The pump will perform all
necessary calculations and apply dosing limits set in the drug library.
38
OPERATION
Chapter 1

• Enter Bolus amount and confirm with k.

• Enter Bolus time and confirm with k.

• Review and confirm bolus parameters and press b


n to begin bolus.

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, the continuous
infusion will then run. Press n
b to deliver remaining bolus.
• Press s
f to stop the infusion entirely.
• When bolus is stopped intentionally by pressing c, 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.

39
OPERATION
Chapter 1

• If pump was not running, as after an operating alarm, press s


f to begin the
infusion and respond to prompt to deliver remaining bolus as previously
described in this chapter.
The last bolus dose is recorded in the status menu, refer to Chapter 2.3.

1.7 Manual Bolus


The Perfusor® 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.
Note: Drug library limits do not apply to manual boluses.
To deliver a manual bolus:
• While an infusion is running, press b
n.
• Select “Use manual bolus feature”.

• Press and hold n


b.
• Bolus amount will count up on pump display.

Manual bolus is limited to 10 seconds.


The pump may be set in the configuration data to emit an audible tone every 1 mL of
solution delivered.
Bolus amount will be displayed when 10 seconds is complete or n
b is released.
The pump converts to the continuous infusion when the n
b is released or
10 seconds is completed.

1.8 Changing Care Unit


The Perfusor® 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: if the drug or concentration are not available
in the new Care Unit, if bolus settings do not match, or if hard limit is exceeded.
40
OPERATION
Chapter 1

To change a Care Unit:


• While infusion is running press the c to get to home screen.
• Scroll to “Change Care Unit”, select with l or k.

• Scroll to desired Care Unit and select with l or k.


• Pump will display confirmation of new Care Unit.

The doserate, dose or time editor will appear and require confirmation if parameter
exceeds the soft limit in the new Care Unit. The soft limit warning will be shown
requiring an override or new programming to proceed as in Chapter 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.

1.9 Changing Display While Pump is Running


• While pump is running, press d 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 Unit, etc. Displayed value will
remain until changed by user.

1.10 Basic Infusion (programming the pump outside of


the drug library)
The Perfusor® 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. 41
OPERATION
Chapter 1

• The pump provides a prompt that programming outside the drug library has
no safety limits, press k.

• A second prompt requires responding yes with u to "Continue without limits?".

• Respond “yes” or “no” to "Use dose rate calc?" (if configured). See Chapter 2.2.3
Note: While under Basic Infusion, the pump is not using any drug library safety limits.
• The pump requires user to enter rate, or VTBI and time which results in
calculation of rate. The pump will determine, but not display, the VTBI by
sensing the syringe plunger location and infuse until the syringe end alarm
or VTBI may be programmed to a value less than the syringe volume.

Programmed bolus and manual bolus are also available in Basic mode, see Chapter
1.4, 1.6, and 1.7. 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 10 mL/hr and time of 20 hrs is
programmed, the VTBI is calculated. When rate is titrated, the VTBI is changed, not
the time. If the rate and VTBI are initially 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.

42
OPERATION
Chapter 1

• 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.
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.

1.11 Syringe Change and New Therapy Start


Note: Always clamp and/or disconnect the line from the patient before changing
syringe to avoid inadvertent flow.
• Press sf to stop the delivery. The green LED goes out. Clamp and disconnect
line from the patient.
• Open the syringe holder and respond to prompt that IV-line is clamped, syringe
driver will open. Lower pump door and remove syringe.
Note: In the unlikely event the plunger plate is not released by the claws, remove
cover from the drive head and press the emergency release button to unlock the
claws on the drive head. The emergency release button is located on the exterior
of the drive head. It can be released by being pressed by a pointed object (e.g.
pen). The claws can then be opened manually and the syringe removed. The
device should then be sent to service for repair.

Remove drive head cover.

Insert pointed object (e.g. pen) into


hole on end of drive head to release
claws.

43
OPERATION
Chapter 1

• Insert new syringe per Chapter 1.1. Open the roller clamp.
• If prompted, prime the pump with u. Then press d to proceed when priming is
complete.
• Connect infusion line to patient and check the parameters with t.
• Start the infusion by pressing s
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".

1.12 End of Infusion


• Press s
f to stop the infusion. The green LED goes out. Close the roller clamp
and disconnect the line from the patient.
• Remove syringe per Chapter 1.11.
• 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 syringe inserted.

1.13 Standby Mode

The pump may be placed in standby rather than powering off so that re-starting an
infusion is quicker.
• Press s
f to stop the infusion, leave syringe 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.

44
PUMP MENUS
Chapter 2

PUMP MENUS
Menus are accessed from the Home screen using q . Press c while pump is running
to access home menu. All menus may be accessed while the pump is running. 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. Total volume is displayed. Press l to clear and
respond to prompt to zero the value.

45
PUMP MENUS
Chapter 2

Pumps with U15 software: The infusion totals are cleared when cleared by user, on
power cycle and when previous infusion is not continued if prompted on power up.
Pumps with U 11 and U12 software: The infusion totals are cleared when cleared by
user and when previous infusion is not continued if prompted on power up. Totals are
NOT cleared on power cycle when no prompt to continue last infusion is configured.
To determine SW version go the Status menu on the home screen and scroll to version

2.2 Options

2.2.1 Downstream Occlusion Pressure

The downstream occlusion pressure setting is the threshold at which the plunger force
or occlusion pressure threshold will result in an occlusion alarm. The lower the plunger
force setting or occlusion pressure threshold setting, the shorter the occlusion
detection time. The higher the pressure level is set, the higher the pressure level must
rise before triggering an occlusion pressure alarm.
W Caution: Consider the plunger force or occlusion pressure threshold setting and
adjust it, as necessary. The lower plunger force setting or occlusion
pressure threshold setting, the shorter the occlusion detection time.
However, when infusing viscous or thick fluids (e.g. lipids) the plunger
force or occlusion pressure threshold setting may need to be adjusted to
reduce false alarms.
• 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 infusion is cleared by
pressing the C key or pump is powered off, pressure level returns to default
value set in service program unless drug selected has a different pressure level
set in the drug library.

2.2.2 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.
46
PUMP MENUS
Chapter 2

Note: Alarm volume remains at set level, even during power cycle, until changed
by user.

2.2.3 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
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 syringe) using
q , confirm with k.

• Press k to prompt for entering amount of drug in syringe.

• Enter the amount of drug using q and confirm with k.

• Press k to prompt for entering the volume of the syringe.

47
PUMP MENUS
Chapter 2

• Enter the volume of the syringe using q and confirm with k.

• Select patient parameter, if any, for dosing calculation. Choices are weight,
BSA, or none.

• Select the doserate units.

• Enter doserate using q and confirm with k.


Confirm and start infusion.
• Enter VTBI or Time if desired.
• To exit Dose Rate Calculation, the pump must be stopped. Press the c from
Home screen and answer “yes” to “Exit and clear infusion?”

48
PUMP MENUS
Chapter 2

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.
• Scroll to and select “Options”.
• Scroll to and select “Assign to drug library”.

• 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.

2.2.4 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 s
f are locked and require entry of data lock code. The syringe
may be changed.
Level 2:
Functions the same as level 1 and in addition 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 Level 1 Level 2 Level 3


Syringe Change  with code for
 level 2/3
Start infusion 
Change parameters   
Stop infusion %
Powering off pump / Standby  %
Displays customized message when
running NA NA

= possible |  = requires code | %= followed by data lock alarm


49
PUMP MENUS
Chapter 2

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.

Note: 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.

2.2.5 KVO-Mode

The pump can continue the infusion with a preset KVO rate after an infusion time or
VTBI has ended and syringe is not empty. 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.

50
PUMP MENUS
Chapter 2

2.2.6 Contrast / Display Light / Keypad Light

Contrast as well as display and keypad light can be adjusted individually according to
the lighting conditions.
• Open contrast/display light/keypad light in Options Menu by pressing l.
• Choose between 9 contrast and display light levels with l or r and confirm
with k.

2.2.7 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.
Note: Bolus rates and volume may be limited by syringe size, see Chapter 7.1.
• Open bolus rate in Options Menu with l.
• Change bolus rate with q and confirm setting with k.

2.2.8 Date / Time

• Open date/time in the Options Menu with l.


• Modify date and time with q and confirm the setting with k.

2.2.9 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.

2.2.10 Wireless Activation

Allows wireless to be set for active or inactive.

51
PUMP MENUS
Chapter 2

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
• Syringe selection

52
ALARMS
Chapter 3

ALARMS
The Perfusor® Space is equipped with an audible and optical alarm signal.

Alarm- Audible Optical signal Staff call User confirmation


type signal Red LED Yellow LED Text
Device yes flashes off device alarm yes Follow the
Alarm and alarm instruction on the
code display to press k.
Operat- yes flashes off alarm type yes Press k to
ing acknowledge and
Alarm cancel alarm
Pre- yes off constant alarm type (de)activate Press k to
Alarm on via service acknowledge and
program cancel alarm

Reminder yes off constant alarm type yes Press k to


Alarm on acknowledge and
cancel alarm

Alarm no off off alarm type no Message disappears


Hint without confirmation.

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 permanent. Press o for 3 seconds to
switch off the device. Then switch the device on again by pressing o. 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.
"Syringe near end" Syringe volume is almost infused.
“Battery near end“ The battery is almost discharged.
53
ALARMS
Chapter 3

“KVO mode“ VTBI or time are complete and the pump


converted to the KVO rate.
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.

Display message Alarm reason


“Syringe end“ Replace with new syringe. Due to different syringe
tolerances some syringes may not empty completely.
See Chapter 7.1 for more information.
“VTBI infused“ The programmed volume was infused.
Insert new syringe and/or reset VTBI.
“Time expired“ The programmed time has ended.
Insert new syringe 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.
Warning: Ensure the fluid flow to the patient is
OFF to prevent administering an unintended
bolus. An occlusion may pressurize the infusion
tubing and syringe, which can result in an
unintended bolus of drug when the occlusion is
cleared. In order to prevent this additional
bolus, disconnect the tubing, or relieve the
excess pressure through a stopcock, if present.

54
ALARMS
Chapter 3

Display message Alarm reason


“KVO time finished“ The KVO time has ended. Program new settings.
"Syringe holder" Syringe holder opened during an infusion.
“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.
Send pump to biomed.
“Drive blocked“ Drive is blocked from moving due to external
interference. Check syringe drive, if alarm persists
send to service.
“Calibrate device“ Return to service for calibration.
"Claw Malfunction" Emergency release (See Chapter 1.11) was pressed.
Remove syringe and send for service.
“Pump set back to default Pump settings could not be restored.
settings” Enter infusion parameters again.
"Infusion values were cleared” Infusion data could not be restored.
Enter infusion parameters again.
“Data lock" An attempt was made to access the pump without
entering the code.
Enter the correct code.
"Syringe plunger plate not locked" The syringe's plunger plate is not in contact with the
plunger plate sensor. Check syringe placement.
The red LED extinguishes and audible alarm ceases with the acknowledgement of the
operating alarm.

3.3 Reminder Alarms


Reminder alarms occur in 2 different scenarios.
1. A syringe 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).

55
ALARMS
Chapter 3

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.
2. An editor screen was open for programming but no values were confirmed or values
were entered but no syringe 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 cannot be modified”).
Prompts do not have to be confirmed and will disappear within a few seconds.

56
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 s
f to stop infusion when patient condition allows.
• Clamp and disconnect line from patient, remove syringe per Chapter 1.11 and
1.12.
• 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 drug library update is successful when complete. On


power up, display indicates new drug library is activated on pump.

Note: Canceling 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 canceled.

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WIRELESS DRUG LIBRARY UPLOAD
Chapter 4

• Press 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.

58
AUTOPROGRAMMING
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 laptop, review the order and follow your hospital
protocol for scanning the syringe, patient, pump and nurse (optional).
• For initial order ensure pump is on B. Braun landing page (press c to return to
landing page).
• 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.
• New Order message will appear with drug name and mode.

• Press k to accept or c 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 programming outside the drug library per
Chapter 1.10 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 .

Note: Order may be canceled prior to confirming order.


59
AUTOPROGRAMMING
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 auto-programming).
• Press s
f to start infusion.

Updates to Current Primary Infusion


• 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.

New Primary Infusion:


• To accept a new PRIMary order, stop infusion and clear current PRIMary infusion by
pressing c and responding “yes” to clear current infusion.
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 canceled
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 to accept order (pump will come out
of standby).

60
BATTERY OPERATION AND MAINTENANCE
Chapter 6

BATTERY OPERATION AND MAINTENANCE


The battery module of Space guarantees operation independent of AC power when
transporting patients. 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 Perfusor® Space is equipped with a NiMH or 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.

61
BATTERY OPERATION AND MAINTENANCE
Chapter 6

The wireless is only available when using a battery module with a wireless
transceiver and the wireless function is activated via the service program
(HiBaSeD) or within the Options menu of the pump.
The wireless battery module contains a wireless transceiver module to allow
data transmission during transports or when connected to AC power.
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.

W 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 (Original
Equipment Manufacturer) installers must consider suitable module and
antenna installation locations in order to assure there is 20 cm (8 inch)
separation, and end users should 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
may occur 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.
■ Do not short circuit.
■ Do not expose it to water or rain.

W 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.

W Caution: The recommendations of IEC 80001 should be observed.


Note: In case of electrostatic discharge, pump may need to be plugged into wall
outlet to re-start the battery.
The battery is charged by the pump during connection to AC power. When
disconnected from AC or in case of power failure, the pump automatically
switches to battery power.
62
BATTERY OPERATION AND MAINTENANCE
Chapter 6

Connection to AC power is displayed by the symbol in the main menu of


the pump. Recharging of WiFi battery while connected to AC 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 to be stored for long periods of time outside the
pump, it is recommended to fully charge the battery and store it at room
temperature.
W Caution: Batteries may explode or leak if they are opened or incinerated. Consider
disposal directions!

The status of the wireless connection is


displayed on the run screen. When the
wireless transmitter is switched off, wireless
symbol will show "off".

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
and connection to the network is
established.

Additional information regarding the


status of the wireless connection can be
viewed in the Status menu.
SSID: The Service Set Identifier, or SSID, is a name that identifies a particular 802.11
wireless LAN. The SSID can be up to 32 characters long and can only be set with the
service tool HiBaSeD.

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:
63
BATTERY OPERATION AND MAINTENANCE
Chapter 6

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.

6.3 Battery Maintenance


To accurately balance the battery capacity, a cyclical battery maintenance is
necessary. The pump asks the user to perform 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 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 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.
W Caution: When the battery maintenance has not been completed, there is a
possibility of a reduced battery operating time.

64
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

SYRINGES FOR USE WITH PERFUSOR® SPACE


The syringes listed in the following tables may be used with the Perfusor® Space,
however, this may not be a complete list of those syringes qualified for use on the
Perfusor® Space Infusion Pump. Please reference the Perfusor® Space SWU Compatible
Syringes document for additional syringes which may be qualified for use with the
Perfusor® Space Pump. Contact your local Sales/Marketing representative for a copy
of the Perfusor® Space SWU Compatible Syringes document.
Syringes listed include both those manufactured by B. Braun and other suppliers.
Because B. Braun does not control the quality of syringes from other manufacturers it
is possible that quality inconsistencies can lead to changes in technical properties of
the syringe performance in the pump. B. Braun is not liable for deviations caused by
use of a syringe from manufacturers other than B. Braun approved syringes.

7.1 Syringe Flow Rates and Infusion Volumes


The table below lists all syringes validated for use with parenteral, enteral or epidural
infusions with Perfusor® Space and includes information on flow rates and infusion
volumes. Only syringes validated for epidural use may be used for epidural infusions
and are indicated in the table. Neomed syringes are only for enteral use and require
use of compatible tubing.

65
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

Minimum Max. Remaining


Manufacturer/ Minimum recommended Maximum Minimum Maximum volume at syringe Epidural
item # Size rate rate 1 rate bolus rate bolus rate end alarm admin
mL mL/h mL/h mL/h mL/h mL/h mL
B. Braun Omnifix
4610303-02 3 0.01 0.1 100 1 150 0.1 no
4617053V-02 5 0.01 0.1 200 1 300 0.1 no
4617100V-02 10 0.01 0.1 300 1 500 0.2 no
4617207V-02 20 0.01 0.2 500 1 800 0.2 no
4617304F-02 30 0.01 0.2 700 1 1200 0.4 yes
US4617509F-02 50 0.01 0.5 999.9 1 1800 0.6 yes
Becton Dickinson
309657 3 0.01 0.1 100 1 150 0.2 no
309646 5 0.01 0.1 200 1 300 0.1 no
302995 10 0.01 0.1 300 1 500 0.4 no
302830 20 0.01 0.2 500 1 800 0.2 no
302832 30 0.01 0.2 700 1 1200 0.2 yes
309653 50 0.01 0.5 999.9 1 1800 0.6 yes
Monoject
1180300777 3 0.01 0.1 100 1 150 0.1 no
1180600777 6 0.01 0.1 200 1 300 0.1 no
1181200777 12 0.01 0.1 300 1 500 0.5 no
1182000777 20 0.01 0.2 500 1 800 0.2 no
1183500777 35 0.01 0.2 700 1 1200 0.6 yes
1186000777T 60 0.01 0.5 999.9 1 1800 0.1 yes
Neomed
(Enteral only)
NM-S6NC /
PNM-S6NC 6 0.01 0.1 200 1 300 0.2 no
NM-S12NC /
PNM-S12NC 12 0.01 0.1 300 1 500 0.4 no
NM-S20NC /
PNM-S20NC 20 0.01 0.2 500 1 800 0.1 no
NM-S35NC /
PNM-S35NC 35 0.01 0.2 700 1 1200 0.5 no
NM-S60NC /
PNM-S60NC 60 0.01 0.5 999.9 1 1800 0.2 no

1 Accuracy for rates below minimum recommended rate is +/-20%

66
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

7.2 Time to Occlusion


The table below lists time to occlusion for each syringe at pressure settings
1 (75 mmHg), 5 (487 mmHg) and 9 (900 mmHg) and flow rates 0.01, 1 and 5 mL/hr
as well as post occlusion bolus volumes.

Max. Time to Max. Time Max. Time Maximum Post


Manufacturer/ Syringe Pressure occlusion at to occlusion to occlusion occlusion
item # size Level 0.01 mL/h at 1 mL/h at 5 mL/h bolus volume
hr:min:sec hr:min:sec hr:min:sec mL
B Braun Omnifix
3 mL P1 > 3h --- 00:00:45 < 0.1
4610303-02 P5 > 3h --- 00:01:30 < 0.1

P9 > 3h --- 00:02:30 < 0.1

4617053V-02 5 mL P1 > 3h --- 00:00:45 < 0.1


P5 > 3h --- 00:02:00 0.1
P9 > 3h --- 00:03:00 0.1
4617100V-02 10 mL P1 > 3h --- 00:01:30 < 0.1
P5 > 3h --- 00:02:30 0.1
P9 > 3h --- 00:03:40 0.1
4617207V-02 20 mL P1 > 3h --- 00:01:00 < 0.1
P5 > 3h --- 00:04:00 0.1
P9 > 3h --- 00:06:00 0.1
4617304F-02 30 mL P1 > 3h --- 00:01:00 < 0.1
P5 > 3h --- 00:06:00 0.1
P9 > 3h --- 00:09:00 0.2
US4617509F-02 50 mL P1 > 3h 00:12:50 00:02:30 0.2
P5 > 3h 01:02:40 00:09:30 0.2
P9 > 3h 01:30:30 00:16:00 0.2
Becton Dickinson
309657 3 mL P1 > 3h 00:04:15 00:01:00 < 0.1
P5 > 3h 00:10:45 00:02:10 0.1
P9 > 3h 00:17:00 00:03:00 0.2
309646 5 mL P1 > 3h 00:07:30 00:01:10 < 0.1
P5 > 3h 00:12:30 00:02:15 0.1
P9 > 3h 00:18:00 00:03:15 0.2
302995 10 mL P1 > 3h --- 00:01:00 0.1
P5 > 3h --- 00:03:20 0.2
P9 > 3h --- 00:04:15 0.2
302830 20 mL P1 > 3h 00:13:00 00:02:30 0.2
P5 > 3h 00:25:00 00:04:45 0.2
P9 > 3h 00:36:00 00:07:15 0.2
302832 30 mL P1 > 3h 00:17:00 00:02:45 0.2
P5 > 3h 00:41:00 00:07:45 0.25
P9 > 3h 00:56:00 00:10:00 0.25
309653 50 mL P1 > 3h 00:10:00 00:03:45 0.2
P5 > 3h 01:05:00 00:14:00 0.25
P9 > 3h 01:35:00 00:18:00 0.25

67
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

Max. Time Max. Time Max. Time Maximum Post


Manufacturer/ Syringe Pressure to occlusion at to occlusion to occlusion at occlusion
item # size Level 0.01 mL/h at 1 mL/h 5 mL/h bolus volume
hr:min:sec hr:min:sec hr:min:sec mL
Monoject
1180300777 3 mL P1 > 3h --- 00:00:40 < 0.1
P5 > 3h --- 00:01:15 0.1
P9 > 3h --- 00:02:00 0.1
1180600777 6 mL P1 > 3h --- 00:00:30 < 0.1
P5 > 3h --- 00:01:00 < 0.1
P9 > 3h --- 00:01:45 < 0.1
1181200777 12 mL P1 > 3h --- 00:00:45 < 0.1
P5 > 3h --- 00:01:30 < 0.1
P9 > 3h --- 00:02:45 < 0.1
1182000777 20 mL P1 > 3h --- 00:01:40 0.1
P5 > 3h --- 00:04:30 0.1
P9 > 3h --- 00:07:00 0.1
1183500777 35 mL P1 > 3h --- 00:01:00 < 0.1
P5 > 3h --- 00:08:00 0.1
P9 > 3h --- 00:14:00 0.2
1186000777T 60 mL P1 > 3h --- 00:01:15 0.1
P5 > 3h --- 00:08:30 0.2
P9 > 3h --- 00:14:30 0.2
Neomed
NM-S6NC / PNM-S6NC 6 mL P1 > 3h --- 00:04:00 0.3
P5 > 3h --- 00:07:30 0.4
P9 > 3h --- 00:10:40 0.6
NM-S12NC / PNM-S12NC 12 mL P1 > 3h --- 00:03:50 0.3
P5 > 3h --- 00:07:50 0.6
P9 > 3h --- 00:12:10 0.7
NM-S20NC / PNM-S20NC 20 mL P1 > 3h --- 00:06:30 0.4
P5 > 3h --- 00:10:40 0.6
P9 > 3h --- 00:15:50 0.7
NM-S35NC / PNM-S35NC 35 mL P1 > 3h --- 00:08:10 0.4
P5 > 3h --- 00:16:00 0.7
P9 > 3h --- 00:23:00 0.8
NM-S60NC / PNM-S60NC 60 mL P1 > 3h --- 00:08:30 0.4
P5 > 3h --- 00:16:30 0.4
P9 > 3h --- 00:24:00 0.6

Note: Values for "Max. time to occlusion at 1 mL/h" are given for representative syringe types only.
Note: Values for “maximum post occlusion bolus volume” are given for small bore and microbore
tubing only. For standard bore tubing the values can be up to 0.4 mL in addition, depending on the
pressure settings.
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SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

7.3 Administration Sets for Use with Perfusor® Space

B. Braun Microbore Sets


Material # Description
V6220 Microbore Extension Set with Female Luer Lock Connector, Spin-Lock® Connector,
and PE Fluid Path Tubing, 36 in., ID 0.020 in., priming volume 0.3 mL
V6203 Microbore Extension Set with Female Luer Lock Connector, Spin-Lock® Connector,
and PE Fluid Path Tubing, 36 in., ID 0.030 in., priming volume 0.6 mL
V6222 Microbore Extension Set with Female Luer Lock Connector, Spin-Lock® Connector,
and PE Fluid Path Tubing, 60 in., ID 0.020 in., priming volume 0.5 mL
V6223 Microbore Extension Set with Female Luer Lock Connector, Spin-Lock® Connector,
and PE Fluid Path Tubing, 60 in., ID 0.030 in., priming volume 0.8 mL
V6215 Microbore Extension Set with Female Luer Lock Connector, Supor® Membrane
0.2 µm Air Eliminating Filter, Spin-Lock® Connector, and PE Fluid Path Tubing, 60 in.,
ID 0.030 in., priming volume 1.3 mL
V5424 Microbore Extension Set with Female and Male Luer Lock Connectors, 19 in.,
ID 0.050 in., priming volume 0.6 mL
V5450 Microbore Extension Set with two Male Luer Lock Connectors. Proximal and distal
male luer locks., 0.04 in. ID., slide clamp. Priming volume: 0.6 mL, Length: 31 in.
(79 cm)

B. Braun Standard Bore Sets


Material # Description
V5402 Extension Set with Injection Site and Female Luer Lock and Spin-Lock® Connector,
8 in., ID 0.108 in., priming volume 1.2 mL
V5406 Extension Set with Female Luer Lock Connector and Spin-Lock® Connector, 21 in.,
ID 0.108 in., priming volume 3 mL
V5409 Extension Set with Female Luer Lock Connector, two Injection Sites, and Spin-Lock®
Connector, 34 in., ID 0.108 in., priming volume 5 mL
V5484 Extension Set with Female Luer Lock Connector and Spin-Lock® Connector, 31 in.,
ID 0.108 in., priming volume 4.3 mL
473012 Extension Set with Female Luer Lock Connector and Spin-Lock® Connector, 30 in.,
ID 0.110 in., priming volume 4.3 mL

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SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7

B. Braun Small Bore Sets


Material # Description
473105 Smallbore Extension Set with Female Luer Lock Connector and Spin-Lock®
Connector, 13 in., ID 0.050 in., priming volume 0.4 mL
471973 Smallbore Extension Set with Female Luer Lock and Spin-Lock® Connectors, 61 in.,
ID 0.050 in., priming volume 2 mL
473022 Smallbore T-Port Extension Set with Female Luer Lock Connector, Injection Site on
Male Luer Slip T-Port, and removable Slide Clamp, 38 in., ID 0.050 in., priming
volume 1.2 mL

Note: For enteral administration use enteral administration sets with ENFit
connector.
Contact your local B. Braun sales representative for the most up to date list
of B. Braun extension sets validated for use with the Perfusor®.

70
START UP GRAPHS AND TRUMPET CURVES
Chapter 8

START UP GRAPHS AND TRUMPET CURVES


Start Up Graphs Trumpet Curves

The graphs show the accuracy/uniformity of flow in relation to time.


The delivery behavior 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 Δt = 0.5 min
Observation interval p x Δt [min]

Start Up Graphs
Measurement interval Δt = 0.5 min
Measurement duration T = 120 min
Flow Qi (mL/h)

Note: The start up of fluid delivery by a syringe pump follows a startup curve as
described in this chapter. The material in the piston of syringes creates
friction forces such that fluid flow from the syringe may not be immediate
upon pressing start with a newly inserted syringe. To reduce the time to
overcome the friction force of the syringe and shorten start up times, a
mechanism to improve the start-up behavior is incorporated in the syringe
pump. This feature reduces the time for fluid to exit the syringe by
applying additional motor steps, to a maximum of 50 mcl of volume at the
start of the infusion. This feature is only engaged after insertion of a
syringe. When restarting an infusion, e.g. after an occlusion alarm, the
feature is inactive.
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TECHNICAL DATA
Chapter 9

T E C H N I C A L D ATA

Type of unit Syringe infusion pump


Classification (acc. to IEC/EN 60601-1) defibrillator-proof; CF equipment
Protective Class II; Protective Class I in
combination with SpaceStation
Moisture protection IP 22 (drip protected for horizontal usage)
External power supply:
• Rated voltage Via B. Braun SpaceStation or optional
AC adaptor (rated voltage 100 - 240 V
AC~, 50-60 Hz) for stand alone operation
• External low voltage 11 – 16 V DC 8 VA typically, 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 30 % – 90 % (without condensation)
• Temperature +41° F – +105° F (+5° C - +40° C)
• Atmospheric pressure 500 – 1060 mbar
Storage conditions:
• Relative humidity 20 % – 90 % (without condensation)
• Temperature -4° F – +131° F (-20° C - +55° C)
• Atmospheric pressure 500 – 1060 mbar
Type of battery pack (rechargeable) Li-Ion, NiMH
Operating time: Li-Ion wireless active Perfusor®
at 5 mL/hr typically 4 hours
at 25 mL/hr typically 2.5 hours
wireless inactive Perfusor®
at 5 mL/hr typically 15 hours
at 25 mL/hr typically 10 hours
NiMH at 5 mL/hr typically 19 hours
at 25 mL/hr typically 10 hours
Recharging time Approximately 6 hours
Weight Approximately 3.1 lbs (1.4 kg)
Dimensions (W x H x D) 9.8 x 2.6 x 5.9 inches (249 x 68 x 152 mm)
Volume increments 0.01 - 99.99 mL in increments of 0.01 mL
100.0 – 999.0 mL in increments 0.1 mL
1,000 – 9,999 mL in increments 1 mL
Time selection 00:01 – 99:59 h
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TECHNICAL DATA
Chapter 9

Accuracy of set delivery rate ± 2 % according to IEC/EN 60601-2-24


Administration Set Change Interval Please refer to instructions for use of
administration set
Max. Volume in case of single fault For incorrect dosages of 0.1 mL due to
condition malfunctions of the device, the pump will
alarm and automatically shut off
Technical inspection (safety check) Every 2 years
Rate increments 0.01 - 99.99 mL/h in increments of
0.01 mL/h
100.0 - 999.9 mL/h in increments of
0.1 mL/h
Multiple lines connected to one Connecting multiple infusion lines with
patient port different flow rates will temporarily
affect the rate for all infusions past the
point of connection when the flow rate
for one is changed.
Accuracy of bolus infusion typically ± 2 % for a bolus volume > 1 mL
KVO rate KVO rates are set in configuration data
for rates < 1 mL/hr, < 10mL/hr and
> 10 mL/hr. Pump will not infuse KVO
rate above current infusion flow rate.
Occlusion alarm pressures
(downstream pressure) 9 levels from 75 mmHg to 900 mmHg
Alarm volume 9 levels (>50dBa to >65dBa)
Pump log 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.

W 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 B. Braun Omnifix® 50 mL syringe and Original
Perfusor® Line (150 cm) at 22° C. This technical data can change when
using different set configurations.
• Use only infusion lines that tolerate a minimum pressure of 2 bar or
1500 mmHg to avoid influencing performance data.
• Use only compatible combinations of equipment, accessories, working parts
and disposables.

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TECHNICAL DATA
Chapter 9

• The Perfusor® Space System is unsafe to use in proximity to magnetic


resonance imaging (MR) equipment.
• Only use Perfusor® Space System 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 against unintended bolus volumes and occlusion (per IEC
60601-2-24)
• Alarm signal of high priority (per 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 = g
milli gram = mg
micro gram = mcg
nano gram = ng
unit = U
milli unit = mU
kilo unit = kU
million unit = MU
milli equivalent = mEq
milli mole = mmol
kilo calorie = kcal
milli liter = mL
kilo gram = kg
meters squared = m2
body surface area = BSA
minutes = min
hour = h
seconds = 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. The dosing units may be pre-set in the drug library (refer to Chapter 1.2)
or selected when using the Dose Rate Calculator (refer to Chapter 2.2.3).

74
TECHNICAL DATA
Chapter 9

Drug Units Patient Units Time Units


ng (none) min
mcg kg h
mg m2 24h
g sec (bolus only)
meq
mmol
mU
U
kU*
MU*
kcal**
Rate Units
mL (none) h
mL kg h
* 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/h) = Dose/concentration x (patient weight or BSA)

Perfusor® Space 2nd Generation - Default Settings


Note: The following settings are the factory default settings contained in the pump.
Most of these settings can be customized based on facility preference by using
the B. Braun HiBaSeD Service Software. Please contact your B. Braun
Representative for more information on how to customize these settings.

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TECHNICAL DATA
Chapter 9

Rates
Menu Item Default Value
Basal
Basal rate minimum 0.1 mL/h
Basal rate maximum 999.9 mL/h
Bolus
Bolus rate minimum 1 mL/h
Bolus rate maximum 1800 mL/h
Bolus Default Rates (by Syringe Size)
for 50/60 mL syringe 1800 mL/h
for 30/35 mL syringe 1200 mL/h
for 20 mL syringe 800 mL/h
for 10/12 mL syringe 500 mL/h
for 5 mL syringe 300 mL/h
for 3 mL syringe 150 mL/h
Bolus volume
Bolus volume minimum 0.1 mL
Bolus volume maximum 60 mL
Priming of the Line
Priming Menu enabled
Priming Volume 0.3 mL
Priming Rate 1800 mL/h

KVO
Menu Item Default Value
KVO Function disabled
Rate
Rate < 1 mL/h 0.1 mL/h
1 mL/h ≤ Rate < 10 mL/h 1 mL/h
(Rate ≥ 10 mL/h) 3 mL/h
KVO Time Limit 0 Min.
KVO Pre-alarm 0 Min.

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TECHNICAL DATA
Chapter 9

Other (adjustable settings at start-up of device/bolus features/pressure defaults)


Menu Item Default Value
General
Bolus Function enabled
Manual Bolus Function enabled
Start-up
Continue last infusion disabled
Use dose rate calculation disabled
(Dose rate calculator)
Default settings
Pressure sensor downstream 5

Menu: Home (Enabled menus will appear on the “Home” screen of the pump)
Menu Item Default Value
Change Care Unit enabled
Options enabled
Status enabled
Infused Totals enabled
Infused Totals Sub-Menu
Total enabled

Menu – Status
(Enabled information will be shown in the “Status” Menu of the pump)

Menu Item Default Value


Battery Capacity enabled
Wireless Status enabled
Software Version enabled
Drug Information enabled
Syringe enabled
Last bolus dose enabled
Last bolus time and date enabled

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TECHNICAL DATA
Chapter 9

Menu - Options
(Enabled functions will be shown and are adjustable in the “Options” Menu of
the pump)

Menu Item Default Value


Downstream pressure enabled
Alarm volume enabled
Assign to drug library enabled
Dose rate calculator enabled
Data lock enabled
Data Lock Pin 9119
KVO mode disabled
Display contrast enabled
Display lighting enabled
Keypad lighting enabled
Bolus rate disabled
Date / Time disabled
Macro Mode disabled
Wireless enabled

Time and Date Options


Menu Item Default Value
Default settings
Standby time 1440 minutes
(24h 00min)
Date format
dd.mm.yyyy disabled
yyyy.mm.dd disabled
Mm/dd/yyyy enabled

78
TECHNICAL DATA
Chapter 9

Alarms
Menu Item Default Value
Pre-Alarms
Syringe end (min) 3 minutes
VTBI (min 10 minutes
Time (min) 10 minutes
Repeating acoustical signal enabled
Battery Empty 30 minutes
Bolus acoustic tone
Every ... mL 1 mL
Syringe Alarms
STOP at syringe end enabled
Low Flow Rate Alert enabled
Staff call options (Off alarms)
Static enabled
Dynamic 1 second disabled
Dynamic 1 second with alarm off disabled
Acoustic Alarm in SpaceStation
(Alarm Status when pump is mounted in Space Station)
Note: only 1 is possible.
Only applicable if pump is placed in a SpaceStation

Only SpaceStation alarms enabled


SpaceStation and pump both alarm disabled
Default Settings
Alarm volume 5

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TECHNICAL DATA
Chapter 9

Display
Menu Item Default Value
Minimal lighting
Pump is turned on and using Battery Power
(not connected to A/C power)
Display Level 1
Keypad Level 0
Passive
Pump is turned off, but it is connected to A/C power.
Display Level 0
Default Settings
Display lighting 8
Display contrast 5
Keypad lighting 5
Macro mode disabled

Service
Menu Item Default Value
Battery Maintenance Mode
Days 256 Days
Active disabled

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TECHNICAL DATA
Chapter 9

Default Disposables
Disposable Brand and Size Factory
Default
Setting
B. Braun Omnifix
50 mL ON
30 mL ON
20 mL ON
10 mL ON
5 mL ON
3 mL ON
Becton Dickinson
50 mL ON
30 mL ON
20 mL ON
10 mL ON
5 mL ON
3 mL ON
Cardinal Monoject
60 mL ON
35 mL ON
20 mL ON
12 mL ON
6 mL ON
3 mL ON
Neomed (Enteral only)
60 mL ON
35 mL ON
20 mL ON
12 mL ON
6 mL ON

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TECHNICAL DATA
Chapter 9

Guidance and manufacturer’s declaration on electromagnetic compatibility

Guidance and manufacturer’s declaration – electromagnetic emission


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

Emissions test Compliance Electromagnetic environment guidance


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

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TECHNICAL DATA
Chapter 9

Guidance and manufacturer’s declaration – electromagnetic immunity


The Space System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Space System or any component should assure that it is used in such
an environment.
Immunity test level Compliance level Electromagnetic
test IEC 60601-1-2 environment – guidance
IEC 60601-2-24
Electrostatic contact ±6KV no disturbances Floors should be wood,
discharge (ESD) IEC 60601-1-2: concrete or ceramic tile.
according ±6KV ±8KV stop with alarm If floors are covered with
IEC 60601-4-2 IEC 60601-2-24: possible synthetic material, the relative
±8KV humidity should be at least
30%.
air ±8KV no disturbances
IEC 60601-1-2:
±8KV ±15KV stop with alarm
IEC 60601-2-24: possible
±15KV
Electrostatic ± 2 kV for power ±2KV AC power quality should be
transient / burst supply lines that of a typical commercial or
according ±1KV hospital environment.
IEC 61000-4-4
± 1 kV for
input/output lines
Surge differential mode ±1KV AC power quality should be
according ±1KV that of a typical commercial or
IEC 61000-4-5 ±2KV hospital environment.
common mode
±2KV
Voltage dips, short < 5 % UT complies by use of AC power quality should be
interruptions and (>95 % dip in UT ) internal battery that of a typical commercial or
voltage variations for 0,5 cycle hospital environment. If the
on power supply user of the Space System
input lines 40 % UT requires continued operation
according (60 % dip in UT ) during long time AC power
IEC 61000-4-11 for 5 cycles interruptions, it is
recommended that the Space
70 % UT System or component be
(30 % dip in UT ) powered from an
for 25 cycles uninterruptible power supply or
a battery.
< 5 % UT
(>95 % dip in UT )
for 5 sec

<5% UT
for 5 s
(>95% dip)
Power frequency 3 A/m 400 A/m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
according location in a typical
IEC 61000-4-8 commercial or hospital
environment.
Note: Different test values of IEC 60601-2-24 are marked in the table. At the test values no
dangerous disturbances occurred at the lower test values of IEC 60601-1-2.
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TECHNICAL DATA
Chapter 9

Guidance and manufacturer’s declaration – electromagnetic immunity


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

Immunity test test level Compliance Electromagnetic


IEC 60601-1-2 level environment - guidance
IEC 60601-2-24
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Space System or it’s components,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.

radiated IEC 60601-1-2:


electromagnetic 3 Veff normal and 10
RF fields Veff in ISM
according frequency band
IEC 61000-4-6 Recommended separation distance
IEC 60601-2-24:
10 Veff 10Veff d = 1.2 √P
150 KHz to 80 MHz 150 KHz to 80 MHz 150 KHz to 80 MHz

radiated 10 V/m 10 V/m d = 1.2 √P


electromagnetic 80 MHz to 2.5 GHz 80 MHz to 3 GHz 80 MHz to 800 MHz
RF fields
according d = 2.3 √P
IEC 61000-4-3 800 MHz to 2.5 GHz

where p is the maximum output


power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended 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.
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TECHNICAL DATA
Chapter 9

NOTE 3: Different test values of IEC 60601-2-24 are marked in the table. At these test values no
dangerous disturbances are allowed while at the lower test values of IEC 60601-1-2. Field
strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an 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.

Band Service max PERP IMMUNITY compliance


TEST LEVEL level E
(MHz) (W) (V/m) (V/m)
380-390 TETRA 400 1.8 27 100
430-470 GMRS460, 2 28 40
FRS 460
704-787 LTE Band 13, 17 2 9 100
800-960 GSM 800/900 2 28 50
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
1700-1990 GSM 1800, 2 28 60
CDMA 1900,
GSM 1900,
DECT,
LTE Band 1, 3, 4, 25,
UMTS
2400-2570 Bluetooth, 2 28 100
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
5100-5800 WLAN 802.11 a/n 0.2 9 100

For all noted services, a minimum separation distance of 0.3 m is recommended.


In case the separation distance is underrun or higher levels of field strength are
present, device alarms may occur.

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TECHNICAL DATA
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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 maximum output power of the communications equipment

rated power of the Separation distance according to frequency of transmitter


ratio transmitter (m)
(W)
150 kHz bis 80 MHz 80 MHz bis 800 MHz 800 MHz bis 2.5 GHz
1.2√P 1.2√P 2.3√P

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.27
100 12 12 23

NOTE 1: For transmitters rated at a maximum power output not listed above, the recommended
separation distance (d) in meters (m) can be determined using the equation applicable to the
frequency of the transmitter, where (P) is the maximum output power rating of the
transmitter 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.

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TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 10

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.

Training
B. Braun offers a training for software version 588U. 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.

Cleaning and Disinfecting


W Caution: Before cleaning and disinfecting the pump, always disconnect the pump
from the patient, switch off the device and disconnect pump from AC
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 Perfusor® Space may be
disinfected with EPA registered hospital disinfectants containing 1-propanol,
isopropyl alcohol, ethanol, didecyl dimethyl ammonium chloride,
diisobutylphenoxyethyl dimethyl benzyl ammonium chloride, or sodium
hypochlorite. 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.

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TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 10

Note: Keep instrument upright and do not allow any part of instrument to
become saturated with or submersed in fluid during cleaning operation.
Do not allow moisture or detergents to come into contact with the electrical
connections of the device (P2 or P3 connectors) or any device openings. To
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.

W 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.

Note: The use of unapproved 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.

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. The device should be tested for proper functioning before initial
use.

Included in Delivery
Perfusor® Space, Battery-Pack SP (with or without Wifi).
88
OPTIONAL SPACE ACCESSORIES
Chapter 11

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 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.

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 Perfusor® 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.
W 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

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OPTIONAL SPACE ACCESSORIES
Chapter 11

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 vehicle socket.
3.) If necessary, remove red adaptor of motor vehicle connector by slightly
turning and simultaneously pulling.
The green LED of the electronic box shows the operating voltage.

W Caution: Plug into vehicle charger and connect to pump. Do not connect
pump to patient if vehicle battery/generator is powering on.

SpaceStation MRI (8713152)

The SpaceStation MRI allows use of up to 4 Space pumps in MR Suite


positioned as close as 20mT/200 Gauss line. Refer to SpaceStation MRI
Instructions for Use.

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OPTIONAL SPACE ACCESSORIES
Chapter 11

turned off turned on turned off


static Operating Alarm
without
Off- Alarm
Alarm*) Operation

dynamic 1 sec
without Alarm
Off–Alarm
Operation

dynamic 1 sec 1 sec


with Alarm
Off-Alarm
Operation

*) in the static mode without Off-Alarm, the staff call can be suppressed with k

W Caution: The user should respond to the local pump alarms as well.

Technical Data
Connecting Wire
white and green white and brown
Alarm disconnected connected
Operation connected disconnected

Polarity of connection is arbitrary:


max. 24 V / 0.5 A / 12 VA

91
ORDERING SPACE ACCESSORIES

Recommended accessories for the B. Braun Perfusor® Space:


SpaceStation .......................................................................................................8713140U
SpaceStation with SpaceCom .......................................................................8713142U
SpaceCover Comfort .........................................................................................8713145U
Space Pole Clamp (speed clamp).... ..............................................................8713131
Power Supply SP (US Plug) ............................................................................8713112D
Combi Lead SP 12 V..........................................................................................8713133
Connection Lead SP (12 V) .............................................................................8713231

92
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,
• brand and size of syringe in use,
• 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.

93
Manufactured by Distributed by
B. Braun Melsungen AG B. Braun Medical Inc.
34209 Melsungen 824 12th Avenue Bethlehem,
Germany PA 18018-3524 USA
Tel +49 56 61 71-0 Clinical and technical support for USA:
Clinical 1-800-854-6851
38910389 • I0047700201 Technical 1-800-627-7867
0721

38910389U_Perfusor Space_US_230721 LLD Order 5404

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