Braun Perfusor Space Instructions For Use Manual
It is recommended that all pumps at
your care unit are equipped with the
same software version.
Perfusor® Space
and Accessories
Instructions for Use
GB
Valid for software 688M
CONTENTS
Perfusor® Space Overview...........................................................................................................................3
Symbols on Product ......................................................................................................................................5
Patient Safety ........................................................................................................................................6
Menu Structure / Navigation...................................................................................................................11
Chapter 1 Operation..........................................................................................................................14
1.1 Start of Infusion .........................................................................................................................14
1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused)
and Time........................................................................................................................................15
1.3 Bolus Application .......................................................................................................................16
1.4 Syringe Change and New Therapy Start .............................................................................17
1.5 End of Infusion............................................................................................................................18
1.6 Standby Mode .............................................................................................................................18
Chapter 2 Advanced Operations ....................................................................................................19
2.1 Status Request of Pump when Infusion is Running ........................................................19
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data.................................................................................................................19
Chapter 3 Special Functions*..........................................................................................................20
3.1 Dosing Units and Dose Rate Calculation (Overview).......................................................20
3.2 Dose Rate Calculation (Operation)........................................................................................21
3.3 Drug Library..................................................................................................................................21
3.4 Patient Controlled Analgesia (PCA) (optional) ..................................................................24
3.5 Target Controlled Infusion (TCI) (optional) .........................................................................26
3.6 Barcoding......................................................................................................................................32
3.7 Ramp and Taper Mode..............................................................................................................32
3.8 Program Mode.............................................................................................................................34
3.9 Intermittent Mode .....................................................................................................................36
3.10Dose Over Time ...........................................................................................................................39
3.11 Take Over Mode (TOM) (optional)..........................................................................................41
Chapter 4 Autoprogramming ..........................................................................................................46
Chapter 5 Options ..............................................................................................................................50
5.1 Occlusion Pressure .....................................................................................................................50
5.2 OccluGuard & Pressure Leap/Drop detection (optional).................................................50
5.3 Data Lock ......................................................................................................................................53
5.4 Bolus Rate.....................................................................................................................................54
5.5 KVO-Mode ....................................................................................................................................54
5.6 Contrast / Display Light / Keypad Light...............................................................................54
5.7 Alarm Volume..............................................................................................................................55
5.8 Date / Time ...................................................................................................................................55
5.9 Macro Mode.................................................................................................................................55
5.10Language.......................................................................................................................................55
Chapter6 Alarms................................................................................................................................56
6.1 Device Alarm................................................................................................................................56
6.2 Pre-Alarms and Operating Alarms ........................................................................................56
6.3 Reminder Alarms ........................................................................................................................60
6.4 Alarm Hints ..................................................................................................................................60
Chapter 7 Battery Operation and Maintenance........................................................................61
Chapter 8 Compatible Syringes......................................................................................................63
Chapter 9 Start Up Graphs and Trumpet Curves ......................................................................68
Chapter10 Technical Data.................................................................................................................69
Chapter 11 Warranty / TSC** / Service / Training / Cleaning / Disposal ..............................76
Chapter 12 Instructions for Use Accessory ...................................................................................79
Ordering .....................................................................................................................................84
*The availability of
the listed features
is depending on
the configuration
of the pump.
**Technical Safety
Check.
2
PERFUSOR SPACE® OVERVIEW
PER F U S OR® SPA C E O V E R VIEW
3
Arrow up and -down
Scroll through menus, change setting of numbers from 0-9,
answer Yes/No questions.
Arrow left and -right
Select data from a scale and switch between digits when
numbers are entered. Open a function while pump is running
or stopped with the left arrow key.
Press to reset single values
to zero and switch back to
the previous screen/menu
level.
Press to Start/Stop
infusion.
Press to initiate
auto-programming orders
when prompted.
Open certain functions
and press to confirm
values/settings/alarms.
Syringe holder locks syringe
in position. The drive will
automatically move back.
Yellow LED: Pre-alarm, reminder alarm
Green LED: Infusing
Red LED: Operating or device alarm
Blue LED: Initiating connection to wireless battery
or Space Station
q
c
k m
Port P2 for power supply, SpaceStation,
connection lead (12V), combi lead and
further accessory leads (staff call, service)
Port P3 for future options
Cover of Battery Compartment
Before changing the battery, always disconnect the pump from the patient and switch off the device.
To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover
away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange.
Press to
initiate
bolus.
Press to turn
pump on/off.
Drive head with
claws to hold the
syringe plunger
plate and
emergency
release button.
o
nB
Sf
PERFUSOR® SPACE OVERVIEW
4
Syringe Fixation
Pull and turn the syringe holder to the right
to open the green axial fixation (see red
arrow). Syringe must be fixed with wings
upright in the slot (found to the left hand
side of the axial fixation) before closing
syringe holder. Make sure that syringe is
properly inserted.
Caution: Don't touch piston brake when
moving forward.
Transport
A maximum of three pumps (Perfusor®
Space or Infusomat® Space) plus one
SpaceControl may be stacked together (in
ambulance cars or helicopters only one
pump). Avoid external mechanical influence.
Locking Devices Together
Line up the bar of the lower pump with the
bar of the pump above and slide the lower
pump backwards until the lock clicks and
the green buttons are above each other.
To disconnect, push green locking buttons
of top pump device and slide bottom pump
forward.
Caution: Avoid external mechanical action.
Fixaton of PoleClamp (Universal Clamp)
Line up bar of pump with bar of PoleClamp
and slide PoleClamp forward until locking
mechanism clicks.
To remove, press release button on frame,
push handle down and pull PoleClamp
backwards.
Pole Fixation
Push the opening of PoleClamp against the
vertical pole and lock the screw tightly.
Unscrew to release.
For vertical fixation of PoleClamp push
lever down and rotate either way until lever
clicks into notch. Push lever for rotation.
Caution: A maximum of three B. Braun
Space pumps can be stacked together
when used with the PoleClamp SP.
Pole clamp handle
Pole clamp
release button
Pump slots
5
SYMBOLS ON PRODUCT
SYM B O L S O N P R O D UCT
Symbol Explanation
See accompanying documents.
Type CF unit with defibrillation protection
Protection class II device
Symbol indicating separate collection for electrical and
electronic equipment (2002/96/EC)
CE mark compliant to Directive 93/42/EEC
Temperature Limit
Moisture Limit
Limitation of the atmospheric pressure
Mandatory action: see instruction for use.
Non-ionizing electromagnetic radiation
General warning sign (e.g. Caution)
6
PATIEN T SAF E T Y
PATIENT S AFETY
Read Instructions
for Use prior to use.
The infusion device
should only be
used by specially
trained staff.
Intended use
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is
intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted
routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, and enteral. The system is used
for the delivery of medications indicated for infusion therapy including but not
limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc.; blood and blood components; Total Parenteral Nutrition (TPN);
lipids, and enteral fluids. The Perfusor® Space Infusion Syringe Pump System is
intended to be used by trained healthcare professionals in healthcare facilities,
home care, outpatient, and medical transport environments.
Using TCI the scope of patients is:
Some parameter sets are using the Lean Body Mass (LBM) to individualize the
parameterization. The LBM calculation may furthermore restrict the scope of
patients as it will not allow TCI for obese patients.
Using TCI the scope of procedures is:
•
Propofol: Anaesthesia and Conscious Sedation
•
Remifentanil: Anaesthesia
The medical specialist must decide on suitability for application on the basis of
the warranted properties and the technical data.
Operation
• The initial training of the Perfusor® Space is to be performed by B. Braun
sales personnel or other authorized persons.
After each software update, the user is required to inform himself of the
changes to the device and accessories by referring to the Instructions for Use.
4w Caution: Ensure the unit is properly positioned and secured. Do not position
pump unit above patient or in a position where a patient could
come to harm, should the pump fall.
•
Prior to administration, visibly inspect the pump and the accessories
(especially the axial fixation) for damage, missing parts or contamination and
check audible and visible alarms during selftest.
•
Not be used adjacent and stacked with other equipment except B. Braun
Space devices.
w
Height [cm]
Weight [kg]
Age [Yrs]
30
Minimum Maximum
200
130 220
16 100
7
PATIENT S AFETY
• Only connect to patient once the syringe has been inserted correctly and
there is proper fixation of the syringe pressure plate by the claws of the drive
head. Interrupt connection during syringe change to prevent incorrect dose
delivery.
•
Select syringe/catheter suitable for use with the intended medical application.
4w Caution: Position the infusion line free of kinks.
•
Recommended change of disposable each 24 h (or as per national hygiene
regulations).
•
Installation in medically used rooms must comply with the appropriate
regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national
specifications and deviations.
4w Caution: Operate the pump at least 25 cm from flammable anaesthetics
to prevent explosion
•
Compare the displayed value with the entered value prior to starting
infusion.
•
If staff call is used we recommend checking the equipment once after
connecting the pump.
•
Protect the device and the power supply against moisture.
•
Do not carry the pump device by it's drive mechanism during transportation.
•
If the pump device falls or is exposed to force it needs to be examined by the
service department.
•
The displayed data must always be checked by the user prior to making
further medical decisions.
•
During mobile use (homecare, patient transport inside and outside the
hospital): Make sure the device is securely fixed and positioned. Positioning
changes and severe shock can lead to minor changes in the delivery accuracy
and/or unintentional bolus administration.
•
A supplemental patient monitoring must be carried out if life-saving
medication is performed.
•
Avoid applying external force on the drive mechanism during administration.
•
In case high potent drugs are given be sure to have a second infusion pump
for that drug at hand. The therapy documentation should be suitable to
continue the therapy at the second infusion pump.
•
Independant of the soft limits the selected values have to be the medically
correct ones for the given patient.
•
In case values relevant for the dose rate calculation (e.g. body weight) are
changing always the flow rate will be updated and the dose rate will be fix.
•
Consider startup characteristics before using low infusion rates (0.1ml/h)
with critical drugs.
Enteral Nutrition
The Perfusor® Space may be used for enteral nutrition. Do not use enteral fluids
for intravenous infusion as this may harm your patient. For this reason only use
disposables dedicated and labeled for enteral nutrition.
Other components
•
Use only pressure proof and compatible disposable items (min. 2 bar/
1500 mm Hg) to avoid influencing performance data - which would result in
impairing patient safety.
•
Where several infusion lines are connected on one single vascular access, the
possibility of the lines exerting a mutual influence over each other cannot be
excluded.
•
Refer to the according manufacturer’s information for possible
incompatibilities of equipment with respect to drugs.
•
Use only compatible combinations of equipment, accessories, working parts
and disposables with luer lock connectors.
•
The use of incompatible disposables may influence the technical
specifications of the device.
•
Connected electrical equipment must comply with the relevant IEC/EN-
specifications (e.g. IEC/EN 60950 for data-processing equipment).
The user/operator is responsible for the system configuration if additional
equipment is connected. The international standard IEC/EN 60601-1-1 has to
be taken into account.
Safety Standards
Perfusor® Space satisfies all safety standards for medical electrical devices in
compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24.
•
The EMC-limits (electro-magnetic compatibility) according to
IEC 60601-1-2:2007 and IEC 60601-2-24: 2012 are maintained. If the
equipment is operated in the vicinity of other equipment which may cause
high levels of interference (e.g. HF surgical equipment, nuclear spin
tomography units, mobile telephones etc.) may be disturbed. Maintain the
protective distancesrecommended by the manufacturers of these devices.
•
The Perfusor® Space fulfils the applicable requirements of EN 13718 to be
used in the air, on the water and in difficult terrain. During transport the
Perfusor® Space needs to be fixed on a suitable restraint system by means of
SpaceStation or Pole Clamp SP. When stored under temperature conditions
beyond the defined operating conditions the Perfusor® Space needs to
remain under room temperature at least one hour before usage.
Safety Instructions for using PCA
•
In case the demand button is used with SpaceStation the PCA pump has to
be placed in the lowest slot of the lowest SpaceStation.
PATIENT S AFETY
8
9
PATIENT S AFETY
• Access to the pump settings can be prohibited by DataLock 3. The code for
DataLock level 3 should differ from the one for levels 1 and 2 in case the
pump is only allowed to be used by pain management professionals.
•
For additional safety the removal of the syringe can be prevented by the use
of the Syringe Anti Removal Cap (see accessories) and the locking of the
syringe holder. The Syringe Anti Removal Cap is usable for the following
syringes: B. Braun Original Perfusor Syringe 50 ml, B. Braun Omnifix 50 ml,
BD Plastipak 50/60 ml and Tyco Monoject 50 ml. The locking of the syringe
holder is under the pump and is locked by a clockwise turn of 90°. Make sure
the syringe holder is safely locked. Opening of the syringe holder may not be
possible after locking.
•
In case opioids are administered and the Syringe Anti Removal Cap is not in
use and the syringe holder is not locked the therapy only should be
performed under surveillance of medical staff. This especially is necessary in
case non-authorised access to the drug can be anticipated.
•
When ending PCA and starting it again the therapy data are set to default
values.
•
Using the demand button also the patient is a permitted user. With the
demand button only a PCA-bolus can be requested. This is limited to pre defined doses by drug list and pump settings.
•
Consider startup characteristics before using low infusion rates (0.1ml/h)
with critical drugs.
Safety instructions for using TCI
•
TCI should only be performed by experienced anaesthetists being familiar
with the principles of TCI and properly trained in using the present device.
•
The use of TCI with B. Braun Space does not limit the responsibility of the
anaesthetist for administration of drugs. They need to be fully aware of the
available literature for any parameter set used in association with a drug and
need to refer to the prescribed information for rate and dosing limits.
•
Pharmacokinetic and pharmacodynamic interactions among anaesthetic
drugs are known, but are not taken into account into the calculation of the
plasma and effect site concentrations. They have to be taken into account by
the user.
•
In particular, the user must be aware that starting the TCI will result in the
automatic infusion of a pre-calculated bolus dose followed by an infusion to
achieve the selected target concentration.
•
It is essential that the user verifies that the patient characteristics and the
selected target concentration as well as the resulting dosages conform to the
prescribing information of the relevant country.
•
B. Braun has verified the accuracy of the mathematical model
implementation, the usability as well as pump delivery accuracy.
10
PATIENT S AFETY
• While using TCI an appropriate patient monitoring is mandatory.
•
Take care of using the right dilution/concentration of the drug and make sure
the right dilution is selected at the pump.
•
Never administer Propofol or Remifentanil by a second infusion as long as
you use TCI.
•
It is possible to completely switch off the TCI mode to avoid the use of TCI
accidentally.
Safety Instructions for using Pole Clamp
1. Line pump up with the Pole Clamp
guide rails.
2. Slide pump fully into place onto the
guide rails.
3. An audible “Click” should heard.
4. Test the pump is secure.
W
The pump ist now securely attached to
Pole Clamp.
• Do not lean on the pump when
attached to the Pole Clamp.
• Do not position the pump unit
above the patient.
W
• DO NOT use any Pole Clamp that
shows signs of damage.
• DO NOT use Pole Clamp with
missing clamp grids.
Underside view
Clamp grids
11
MENU STRUCTURE / NAVIGATION
MENU STRUCTURE / NAVIGATION
At the top of the screen the last therapy is
indicated. Yes/No question can be
answered by pressing ufor yes or d
for no.
Parameters which can be changed (e.g.
rate in ml/h) are opened with l or
k. When editing parameters, switch
digits/levels using l r. White
background indicates current
digit/level. Use u or d to change
current setting. Help text on the
bottom/top of the screen indicates
options how to proceed (e.g. confirm
rate with k, start infusion with sf
or clear rate by pressing c).
Display Meaning
Mains
connection
Battery
status
Unit of drug application
Active VTBI- or time preselection
Scrolling arrows indicate pump is infusing
Set rate can be opened with l
Set pressure limit and current pressure*
*See also OccluGuard
Therapy profile
Typical display during infusion:
Total volume infused. Alternatively the intermediate volume can be displayed.
Remaining time
Remaining VTBI
Cutline
o On/Off button
sf Start/Stop button
nb Bolus button
c Clear button
k OK button
q Keypad with arrow up, -down,
-left, -right button
m Connection button
All display screen shots are examples and may be different when related to an
individual patient and individualized therapy.
12
MENU STRUCTURE / NAVIGATION
Set pressure level with l or r and con-
firm by pressing k.
Cancel to edit pressure by using c.
Pre-alarms are indicated by the message
on the display (e.g. “Syringe nearly
empty”), an audible tone and the yellow
LED is constantly on. To confirm a
pre-alarm press k.
In case of an operating alarm (e.g.
"Syringe empty") the infusion stops, an
audible tone sounds and the red LED is
flashing. Confirm alarm by using
k.
Confirming does not activate an acoustic
feedback
Press and hold o for 3 sec to turn pump
off. A white bar stretches from left to right
and counts down the 3 sec.
As long there is a syringe inserted the
pump will not turn off but will use standby.
Display Meaning
This hint pops up if a user tries to edit or
change a parameter by pressing l when
that parameter is unable to be changed.
nb has been pressed while the pump is
infusing. Start manual bolus at
1200 ml/h by pressing k (see top of
display) or proceed to set bolus limit
with l (see bottom of display).
All status information is available in the
bottom line of the dislplay. The desired
information can be selected by using
d
u and will be displayed permanently
thereafter (e. g. drug long name, time until
syringe empty, current system pressure
etc.).
Prime ?
S
tart Up
Menu
M
ain
Menu
S
tatus
Menu
Syringe
s
election
R
ate
S
pecial
Functions
Dose Rate
C
alculation
VTBI
Time
U
se last
therapy ?
Use dose rate
calculation ?
Use drug
library ?
Weight
Concentration
D
ose
Drug Library
Change-over
from
c
ontinuous
mode to PCA
Intermediate
v
olume
I
ntermediate
amount
I
ntermediate
time
Total
volume
Special
Functions
Options
Status
O
ptions
Menu
Occlusion
P
ressure
Total
amount
Total
time
Pressure
OccluGuard
Status
Syringe
Battery
capacity
WLan
Version
Drug
info
Bolus
Rate
KVO-
Mode
Display
Light
Keypad
Light
Alarm
Volume
OccluGuard
P
ressure
Leap/Drop
Contrast
Date
Time
Macro
Mode
In Dose Mode:
Display of flow
rate in large
scale
D
ata
Lock
Language
13
MENU STRUCTURE / NAVIGATION
14
Chapter 1
OPERATION
OPE RATION
1.1 Start of Infusion
• Ensure correct installation of the pump device. If the pump is connected to mains,
the display states information such as the battery status, the mains connection
symbol and the last therapy.
•
Press o to switch on unit. Note the automatic selfcheck: “Selftest active” and the
software version are displayed, two audible tones sound and all three LEDs (yellow,
green/red and blue) flash once. Information on power supply (battery or mains
connection), the set pressure level and the syringe (if syringe already inserted) are
displayed. Hence the drive moves backwards.
•
Press c to start with direct entry of therapy parameters or open pump cover and
syringe holder to start with syringe insertion.
•
Insert syringe with wings of the syringe upright in the slot to the right of the
housing. Close syringe holder and pump door. Piston brake moves forward.
Caution: Never leave the pump unattended during syringe loading.
•
Confirm syringe type with k. Type of syringe indicated must coincide with syringe
inserted.
•
Drive will advance and grip pressure plate of syringe.
Caution: Keep your hands away from advancing device.
Note: Make sure that the piston brake moves back into the syringe holder.
•
If the prime function is activated, press U to prime infusion set at 1200 ml/h
(pressing key once = 1 ml). Interrupt prime function with
k. Repeat procedure
until infusion line is fully primed. Then press
d to proceed.
•
Connect with patient.
•
Respectively answer questions in Start Up Menu with uand d, until the rate is
displayed in the Main Menu.
Enter infusion rate:
•
Press l and set rate using q.
The pump offers the possibility to load up to four languages into the pump
(depending on the number of the language specific characters), among which the
user can choose during the operation of the pump. During the first ever start-up of
the device, the user is requested to select the languages and to mark them with
l.
After that, the selection has to be confirmed by choosing the last menu item at the
bottom of the list and pressing
k. Then the desired language must be selected with
t and confirmed with k. Answer the following question with d in order to
activate the selected language.
15
OPERATION
Chapter 1
• Press sf to commence infusion. Running arrows on display and green LED
above display indicate pump is infusing.
Note: Stop the infusion at any time by pressing sf. The pump can be turned off
at any time by pressing
o for 3 sec (Exception: Data lock level 2) and as long a
disposable is inserted.
1.2 Entry With Different Combinations of Rate, VTBI
(= Volume To Be Infused) and Time
The Perfusor® Space offers the possibility to enter a volume- and time limit in addition
to an infusion rate. When two of these parameters are entered, the third is calculated
by the pump. If a volume and/or time is preselected, an arrow symbol is placed in front
of one of these parameters in the Main Menu. It is called the “target”. During the
infusion of the pump, this target symbol is displayed next to the moving arrows in the
run display (this symbol is not visible in case TCI is used). This indicates that the pump
has been programmed, either with a volume- or time limit. The assignment of the target symbol, apparent in the Main Menu, shows the established parameter for the application (VTBI or time). When the rate is changed, the so-called target parameter is
principally not adjusted to the new rate but to the parameter which does not have the
target symbol in front. After the infusion has started, the remaining VTBI and time are
displayed in the status menu and the run display (values are counting down).
1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the
bottom of the display.
Target: Volume
• Select VTBI with t and open with l.
• Enter VTBI with qand confirm with k.
• Select time with t and open with l.
• Enter time with qand confirm with k.
Check calculated rate on plausibility.
Proceed in the same way to calculate 2.) and 3.).
2.)Infusion with volume limit
Enter rate and VTBI: The infusion time will be calculated and displayed at the
bottom of the display.
Target: VTBI
3.)Infusion with time limit
Enter rate and time: The infusion volume will be calculated and displayed at the
bottom of the display.
Target: Time
Changing already entered values of VTBI and time (rate, VTBI and time already exist
at the point of change):
16
a) Target symbol is placed in front of VTBI:
• Change of VTBI => Adjustment of time. Old and new target: VTBI
• Change of time => Adjustment of rate. Old and new target: VTBI
b) Target symbol is placed in front of time:
• Change of time => Adjustment of VTBI. Old and new target: Time
• Change of VTBI => Adjustment of time. New target: VTBI
Note: Changing VTBI/time is only possible while the pump has been stopped.
1.3 Bolus Application
After pressing the button nb the bolus unit can be selected by using d.
Note: The selected unit will not be stored. It is possible to administer a bolus in ml.
There are three ways to administer a bolus:
1.)Manual Bolus: Press
nb. Then press k and hold button. Fluid is
administered as long as button is held down. The infused bolus volume is
displayed.
The max. bolus volume is limited to 10 sec. Reaching this limit is indicated
by an acoustic signal.
2.)Bolus with volume preselection: Press
nb. Then press l and set bolus dose
limit by using
q. Press nb. to confirm and start bolus. Depending on the
service tool settings an acoustic signal will sound after finishing the bolus
volume.
3.)Bolus with rate calculation: Press
nb. Then press l and set bolus dose
by using
q. Press k to confirm bolus dose. Set time with q in which a
bolus is to be delivered. Calculated bolus rate is shown on top of the display.
Press
nb. to confirm and start bolus.
You can use the service program to enter a default and a maximum bolus rate.
Once a new therapy is started the device always returns to the default rate
- even if the bolus rate was manually changed beforehand.
Note: If the bolus limit is not entered after pressing nb, the pump switches
back into the run display automatically.
Note: The infused volume during bolus with volume preselection counts up.
In order to purge the line at any time while the pump is stopped press
nb.
Answer the following question by pressing
u in order to start the purge
process. Cancel by pressing
u or any other key.
Caution: Take care not to overdose! Given a bolus rate of 1200 ml/h, 1 ml will
be administered in just 3 sec. To cancel bolus infusion at any time press
k.
At low bolus volumes, under dosages due to the start up characteristic of the
pump and the tolerances in the infusion system cannot be excluded. Disconnect
patient while purging.
Chapter 1
OPERATION
17
OPERATION
1.4 Syringe Change and New Therapy Start
Note: To avoid incorrect dosing, always disconnect the pump from the patient when
changing the syringe. Never leave the pump device unattended during syringe change.
Before inserting a new syringe check if the axial fixation is properly working.
•
Press sf to stop the infusion. The green LED will disappear.
Disconnect the pump from the patient.
•
Either the drive mechanism moves backwards into starting position when opening
syringe holder or the question "Perfom change?" must be first answered before the
drive moves backwards.
•
Open pump door, remove syringe and insert new syringe.
Note: In case the plunger head of the syringe is not released anymore by the claws
when performing a syringe change, the emergency release button needs to be pressed
to release the claws of the drive head. The emergency release button is placed on the
outside of the drive head. It can be released with a pointed pen. Then manually open
the claws and take out the syringe.
•
Close the syringe holder (Note: Piston brake must move forward!) and the pump
door and confirm the inserted syringe type with
k. Drive advances and grips
pressure plate of syringe.
Note: Do not block advancing drive unit with any objects. Piston brake must move
backwards into the syringe holder.
•
Prime pump if necessary with uthen press dto continue.
•
Connect the patient to the pump and check set parameters using t.
•
Press sf to start infusion.
To start a new therapy after a syringe change:
•
Press c when pump is in the Main Menu.
•
Press d and continue to set new therapy parameters with q.
• Press sf to start infusion.
Note: A new therapy can be started at any time during a stopped infusion. Press
c (repeatedly) when the pump is in the Main-, Status- or Options Menu and
proceed to follow instructions as described.
1.5 End of Infusion
• Press sf to stop the infusion. The green LED disappears. Disconnect the
pump from the patient.
•
Open the syringe holder. Answer the question whether a syringe change should be
performed with
u. The drive moves backwards into the starting position.
Chapter 1
18
Chapter 1
OPERATION
• Open pump cover. Remove the syringe, move the syringe holder into an upright
position and close the front door.
•
Press o for 3 sec. to switch the pump off. The drive moves into parking
position.
Note: The settings will be permanently saved by the switched off device.
Note: Pump cannot be powered off with syringe inserted.
1.6 Standby Mode
In the case of extended interruption, the user has the option to maintain the set values.
•
Press sf to stop the infusion. Then press o for less than 3 sec.
•
Confirm that the pump is supposed to switch into standby by pressing u.
•
The pump is now in Standby.
While the pump is in the standby mode, it’s display shows the drug and the
remaining time for this mode. Change of remaining time by pressing
l. Exit
standby by pressing
c .
As long as a disposable is inserted in the pump will use standby also in case
o is
pressed for at least or more than 3 sec.
ADVANCED OPERATIONS
2.1 Status Request of Pump when Infusion is Running
Press c to switch between run display and Main Menu while the device is infusing.
Navigate through the menu using
t to check parameters. In order to check the menu
parameters in the Status-/Options Menu, select "Status" respectively "Options" in the
Main Menu, open menu with
l and scroll through menu with t.
2.2 Rate, VTBI and Time Change Without Infusion
Interruption and Reset of Status Menu Data
• Press cwhen the pump is in the run display in order to switch to the Main Menu.
Select rate/VTBI/time with
t and press l in order to open the parameter.
•
Enter new value with q and confirm with k.
Reset Status Menu Data:
The parameters intermediate volume and -time can be reset when the pump is
infusing or when the pump is stopped.
•
Select “Status” in Main Menu with t and press l.
•
Highlight intermediate volume (in ml) or intermediate time (in h:min) with t and
open parameter with
l.
• Reset values by pressing u.
Both parameter total volume and -time, are displayed in the pump as "Total" with the
according unit and can be reset by starting a new therapy. A second way to reset the
parameters when the pump is in the Main Menu: Press
c, answer question if the last
therapy is to be used with
u and reset the values with u.
The type of the inserted syringe is displayed in menu item „Syringe“ and cannot be
changed once it has been confirmed at the beginning of the infusion. The drug info
states the drug name, the name of the drug list and its date of origin. The current
battery capacity in hours and minutes is displayed in the menu item “Battery Cap.” and
the current software version in menu item "Version". In-line pressure can also be read
in the Status menu in mmHg or Bar depending on the service settings.
19
Chapter 1
OPERATION
20
Chapter 2
ADVANCED OPERATIONS
SPE CIAL FUNCTIONS
3.1 Dosing Units and Dose Rate Calculation (Overview)
The following list shows the units used in the pump:
Gram family: ng, mcg, mg, g
Unit family: mIU, IU, kIU, MIU
Equivalents family: mEq
Mole family: mmol
Kilocalorie family: kcal
Millitliter family: ml, ml/kg
In addition to these dosing units the user can choose:
• Feeding: kcal, mEq, mmol
• Surface related amount units: m
2
The pump is calculating the body surface area with the “Dubois” formula
(DuBois D, DuBois EF. A formula. Arch Intern Med 1916; 17: 863):
BSA(m2) = 0.007184 x weight(kg)0.425 x height(cm)0.725.
Check plausibility of calculated body surface area value and resulting delivery
rate before starting the infusion, also, if body surface area related dose rate is
set by Barcode. The dose rate calculation enables a calculation of the rate in
ml/h based on the entered dose parameters.
Setting parameters:
1. Concentration as the amount of the active ingredient per volume.
- Amount of the active ingredient
- Volume in ml
2. Where necessary: Patient weight or Patient height
Note: - Patient weight can be entered in kg, lbs or grams.
- Patient hight is entered in m (is used to calculate BSA)
3. Dose prescription:
- time related as the amount of the active ingredient per min, h or 24h.
- time and patient weight related as the amount of the active
ingredient per kg per min, h or 24h or BSA.
4. Where necessary: VTBI in ml.
Infusion rate [ml/h] =
x
Patient weight (optional)
Dose
Concentration
[]
21
SPECIAL FUNCTIONS
3.2 Dose Rate Calculation (Operation)
a Select dose rate calculation with l.
a Select the unit of the active ingredient with
T and confirm it with l.
a Enter the concentration by entering the amount of the active ingredient
and the volume. In order to do so set the values with
q and confirm
with
k.
a If the patient weight shall not be entered press
d.
Press
t to choose “weight” or “surface” and confirm with k.
a Set the patient weight with
q and confirm with k.
a Select the dose prescription with
t and confirm it with l.
a Set the dose with
q and confirm with k. The rate will automatically
be calculated and displayed at the bottom of the display.
a Check the calculated rate and if necessary the adapted parameters with
t on plausibility before starting the infusion with sf.
Dose can later be changed in the Main Menu in the same way as the rate, VTBI
and time (compare 2.2). During TCI mode after a syringe change, the concentration can only be changed in Main Menu. The effect of dose modifications on
other parameters is shown at the bottom of the display. Additionally the total
and intermediate amount of the infused drug can be taken from the Status
Menu. These can be checked and resetted in the same way as the other total
and intermediate values.
A deactivation of the dose rate calculation is only possible when the pump is
stopped. Press
c from Main Menu and then press d.
Caution: A change of the patient weight or height will alter the flow rate.
3.3 Drug Library
Up to 1200 drug names including therapy data, information and up to 10
concentrations per drug can be stored in 30 categories. These drugs can be
subdivided in 50 care units and 16 Patient Profiles. The loading process into the
pump can be performed via a separate PC program (Space Upload Manager &
HiBaSeD).
Note: The drug library can be started over the Start Up and Special Functions
Menu. The user has to make sure prior to the therapy start that the drug library
in the pump complies with the patient target group. The name of the care unit
and creation date (see headline) should be checked in the pump.
There are different ways of assigning a drug to an infusion. This can be done
while the infusion is running or when the pump is stopped.
Chapter 3
22
Chapter 3
SPECIAL FUNCTIONS
On the one hand, a drug name including the according therapy data can be
taken from the drug library. On the other hand, if a rate, VTBI and/or time were
already defined in the Main Menu, the drug name and the adjusted values of
the data set will be loaded. If a dose rate calculation has already been started a
belated assignment of the drug name nevertheless is possible.
Loading a drug (including the according parameters) from the Main Menu:
• Go to Special Functions Menu and press
l.
• Open the drug library by pressing
l.
• Navigate through the list with
t and select the care unit with l. If you
have already set the care unit once on your pump this step will be skipped for
the next time.
• Change the care unit by navigating through the list until "Change care unit"
will be displayed. Press
k to change the care unit.
• Navigate through the list with
t and select the patient profile with l.
If no profile is set, this step will be skipped.
• Navigate through the list with
t and select in alphabetical order (all drugs)
or within a category with
l.
• If different therapies are related to a drug, choose therapy type with
t and
confirm with
l.
• Confirm the displayed drug information with
l.
• Decide if the safety limits for the drug are to be applied u or if only the
drug name should be used
d.
• Check if the drug short name in the Run Menu is the same as the selected
drug. Check the parameter in the Main Menu with
t and start infusion with
sf.
Note: If a drug name has been assigned without safety limits, the following hint
is provided in the RUN screen:
Note: Care unit and Patient Profile can not be changed within a therapy.
Initial Bolus:
Initial Bolus has to be configured in the Drug List Manager.
• Use the drug library according to the instructions for use.
23
Chapter 3
SPECIAL FUNCTIONS
• Select the desired drug with t and press l.
Before the initial bolus begins, the bolus menu is displayed to allow editing
the bolus with
q.
• Check the parameter and start infusion with
sf.
Hard Limits:
If the set rate/dose/bolus volume and bolus rate exceed the values stored in the
drug library (hard limits), the drug will be rejected, a hint will be displayed and
the pump will fall back into the drug selection. If this occurs while the pump is
infusing the pump will continue to administrate.
Soft Limits:
For the same parameters so called soft limits can be preset via the Drug List
Editor. These can be exceeded without any constraint. The following symbols
that describe the status with regard to the soft limits are being displayed:
The infusion is within the range of the minimum and maximum
soft limits =
The infusion is within the range of the maximum soft limit =
The infusion is within the range of the minimum soft limit =
Violation of the upper soft limit =
Violation of the lower soft limit =
No soft limit is defined =
Only a drug name is available =
(It is possible to select a drug name only from the drug library)
The limits of the drug library have to comply with the limits of the pump and
the disposable.
Note: An adequate monitoring when infusing highly potent drugs is
recommended.
Note: In case a drug from the drug library is selected and the pump is running
under dose rate calculation the initial values will be overwritten by the drug
library values if selected.
Remote Drug Library update from Upload Manager (Space Online Suite)
The file icon blinks every 2 s. An update is available.
24
*Bolus volume is the volume of a single bolus the patient may demand. Max. Limit is the amount of
drug or volume a patient may demand within a certain time in total. Lockout is the time in between
two boli.
The Drug Library Upload starts as soon as the pump is in Passive mode.
Note: You can cancel the upload by pressing c.
Please contact your local sales represantative in case you like to use Remote
Drug Library update.
3.4 Patient Controlled Analgesia (PCA)
For PCA a drug list with at least one drug activating the profile PCA is necessary. By this the conditions for an effective and safe therapy are defined.
Switch on pump with
o and wait until self-check is finished. Depending on
the settings the choice of a drug is offered direcly or the pump is in “Main
Menu”.
Select “Special Functions” with
t from “Main Menu” and confirm with l.
Select drug list, category and desired drug by using
q.
The therapy can be started now with
sf in case all values are defined.
Depending on the pre-defined settings the therapy is started with an initial
bolus and a basal rate or not.
Before leaving the patient the pump should be put into DataLock level 3 with
q in Menu “Options”. This is necessary especially in case non-authorised access
to the settings can be anticipated.
The code is entered with
q and confirmed with k.
After the selection the pump
offers additional drug related
information which are confirmed
by
l.
Select profile PCA by using and
confirm with
t .The therapy set-
tings stored in the drug list are
displayed *.
The pump display now may look
like this.
Chapter 3
SPECIAL FUNCTIONS
25
In this state the patient is allowed to demand boli. Depending on the status of
the therapy these are either administered or denied. Changing the syringe is also
possible by using the code for level 1 or level 2. Altering the settings for PCA or
other therapies however is only possible with the code for level 3.
The status of the therapy can be checked in the menu „Status“ .
Enter the „Main Menu“ with c and select the “Status“ with q.
An acoustic confirmation of demanded boli can be activated and modulated by
t in Data Lock 3.
Is a demand button connected, the therapy symbol looks like this:
In case there is no demand button connected the therapy symbol looks like
this: .
The demand button is connected to the interface P2 at the rear side of the
pump.
Hint: It is possible to start a therapy in continuous mode and switch over to
PCA later on (in case the drug is dedicated for use with continuous and PCA
application).
SpacePCA-Chart
If
r is pressed on the RUN screen, the SpacePCA-Chart is displayed:
The bar represents a time axis, with the points above the axis representing the
number of boli administered and the points below the axis representing the
number of boli refused.
The chart has a 15 minute resolution and shows max of 5 points per 15 minutes. Should more then 5 boli be given or refused in this time, the last point will
be turn bold.
Changes to the PCA parameters are displayed as arrowheads at the bottom of
the chart.
The A/D-ratio indicates the
percentage of administered and
demanded boli thus giving an idea
about the effectivity of the therapy.
Chapter 3
SPECIAL FUNCTIONS
26
3.5 Target Controlled Infusion (TCI)
Introduction
In TCI the user is defining a desired concentration of drug in the human body
(target) rather than an infusion rate. The rates necessary to reach and maintain
that said concentration are calculated by the pump using an algorithm based on
a three-compartment pharmacokinetic model.
A pharmacokinetic model (PK model) is a mathematic model to predict the concentration of a drug in the human body (e.g. plasma level) after a bolus or a
continuous infusion of different duration. A PK model is developed by measurement of plasma level values of a population of patients or volunteers and the
respective statistical analysis. A PK model mostly is a 2- or 3- compartment
model indicating the volumes of the compartments, indicating rates for the
exchange amongst the compartments and indicating rates for elimination /
metabolism of the drug.
A PK model can be parameterized to use it for different drugs as long as it is
suitable for that said drug. The pharmacokinetic model and its parameters are
schematically depicted by the following illustration:
B. Braun Space is offering two modes for TCI:
•
TCI by targeting the plasma concentration
In this mode the user selects the desired concentration of a drug in the
blood plasma and the PK model is used to calculate the infusion rates
required to achieve that concentration as quick as possible (unless there is
no restriction defined by the user).
Chapter 3
SPECIAL FUNCTIONS
27
• TCI by targeting the effect-site concentration
In this mode the user selects the desired concentration of a drug at the site
of action and the PK model is used to calculate the infusion rates required to
achieve that concentration as quick as possible (unless there is no restriction
defined by the user). A certain overshoot of the concentration in the plasma
is resulting from this mode.
For effect-site targeting there is a link between pharmacokinetics and pharmacodynamics necessary. As the effect-site compartment is considered to have no
volume and the rate constant k
1e
can be ignored the rate constant ke0is the
parameter necessary to perform effect-site TCI. A pharmacokinetic model modified in such way is schematically depicted by the illustration on the next page.
TCI with B. Braun Space is possible with two drugs: Propofol and Remifentanil.
For Propofol the user can choose between two parameter sets. The parameter
sets used for these drugs are (Not all parameter sets allow effect-site targeting):
Chapter 3
SPECIAL FUNCTIONS
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