Perfusor Space Syringepump Nextgenerationsoftwareu
Perfusor Space Syringepump Nextgenerationsoftwareu
and Accessories
Rx only
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.
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
5
PERFUSOR® SPACE OVERVIEW
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
7
PERFUSOR® SPACE OVERVIEW
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.
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.
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.
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
• 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
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.
Display Meaning
17
OPTIMIZING PERFORMANCE: START UP TIME, FLOW ACCURACY AND TIME TO OCCLUSION
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.
21
ENTERING VALUES
Arithmetic logic:
An alternative method for entering and titrating values uses arithmetic logic:
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.
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.
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.
24
OPERATION
Chapter 1
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.
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.
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.
• 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
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.
Note: Respond to soft and hard limit dose alerts that occur during titration as
described above.
35
OPERATION
Chapter 1
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.
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.
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.
• 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.
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
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
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.
• The pump provides a prompt that programming outside the drug library has
no safety limits, press k.
• 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
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".
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.
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.
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
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.
Note: Alarm volume remains at set level, even during power cycle, until changed
by user.
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.
• Scroll to and select units for concentration (units of drug in syringe) using
q , confirm with k.
47
PUMP MENUS
Chapter 2
• Select patient parameter, if any, for dosing calculation. Choices are weight,
BSA, or none.
48
PUMP MENUS
Chapter 2
• 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.
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.
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.
50
PUMP MENUS
Chapter 2
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.
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.
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.
51
PUMP MENUS
Chapter 2
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.
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.
54
ALARMS
Chapter 3
55
ALARMS
Chapter 3
56
WIRELESS DRUG LIBRARY UPLOAD
Chapter 4
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.
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.
57
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.
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.
60
BATTERY OPERATION AND MAINTENANCE
Chapter 6
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.
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.
Signal strength: The signal strength shows the quality of the connection.
64
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
65
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
66
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
67
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
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.
68
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
69
SYRINGES FOR USE WITH PERFUSOR® SPACE
Chapter 7
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
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.
71
TECHNICAL DATA
Chapter 9
T E C H N I C A L D ATA
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.
73
TECHNICAL DATA
Chapter 9
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
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
75
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.
76
TECHNICAL DATA
Chapter 9
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)
77
TECHNICAL DATA
Chapter 9
Menu - Options
(Enabled functions will be shown and are adjustable in the “Options” Menu of
the pump)
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
79
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
80
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
81
TECHNICAL DATA
Chapter 9
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.
82
TECHNICAL DATA
Chapter 9
<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.
83
TECHNICAL DATA
Chapter 9
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.
84
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.
85
TECHNICAL DATA
Chapter 9
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
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.
86
TRAINING / TSC* / SERVICE / DISINFECTING / DISPOSAL
Chapter 10
Training
B. Braun offers a training for software version 588U. Please ask your local
representative for further details.
87
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.
89
OPTIONAL SPACE ACCESSORIES
Chapter 11
W Caution: Plug into vehicle charger and connect to pump. Do not connect
pump to patient if vehicle battery/generator is powering on.
90
OPTIONAL SPACE ACCESSORIES
Chapter 11
dynamic 1 sec
without 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
91
ORDERING SPACE ACCESSORIES
92
Technical Support
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