perfusor_space_instructions_for_use_sw_688f__g_-_h.pdf
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Perfusor® Space
and Accessories
Instructions for Use
It is recommended that all pumps at
your ward are equipped with the
same software version.
GB Valid for Software 688F/G/H
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CONTENTS
CONTENTS
Perfusor® Space Overview.......................................................................................................3
Patient Safety
........................................................................................................................5
Menu Structure / Navigation.................................................................................................9
Chapter 1
Operation ..........................................................................................................11
1.1 Start of Infusion .........................................................................................................................11
1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused)
and Time .......................................................................................................................................12
1.3 Bolus Application.......................................................................................................................13
1.4 Syringe Change and New Therapy Start.............................................................................14
1.5 End of Infusion ...........................................................................................................................15
1.6 Standby Mode.............................................................................................................................15
Chapter 2
Advanced Operations....................................................................................16
2.1 Status Request of Pump when Infusion is Running........................................................16
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data ................................................................................................................16
Chapter 3
Special Functions* .........................................................................................17
3.1
3.2
3.3
3.4
3.5
3.6
Chapter 4
Options..............................................................................................................28
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
Chapter 5
Occlusion Pressure.....................................................................................................................28
Data Lock......................................................................................................................................28
Bolus Rate....................................................................................................................................29
KVO-Mode....................................................................................................................................29
Contrast / Display Light / Keypad Light ..............................................................................30
Alarm Volume..............................................................................................................................30
Date / Time ..................................................................................................................................30
Macro Mode ................................................................................................................................30
Language ......................................................................................................................................31
Alarms ...............................................................................................................32
5.1
5.2
5.3
5.4
*The availability of
the listed features
is depending on
the configuration
of the pump.
**Technical Safety
Check.
Dose Rate Calculation (Overview) ........................................................................................17
Dose Rate Calculation (Operation) .......................................................................................17
Drug Library.................................................................................................................................18
Patient Controlled Analgesia (PCA) ......................................................................................19
Target Controlled Infusion (TCI).............................................................................................21
Barcoding .....................................................................................................................................27
Device Alarm ...............................................................................................................................32
Pre-Alarms and Operating Alarms........................................................................................32
Reminder Alarms........................................................................................................................35
Alarm Hints..................................................................................................................................35
Chapter 6
Battery Operation and Maintenance .......................................................36
Chapter 7
Compatible Syringes .....................................................................................38
Chapter 8
Start Up Graphs and Trumpet Curves ......................................................41
Chapter 9
Technical Data ................................................................................................42
Chapter 10 Warranty / TSC** / Service / Training / Cleaning / Disposal..............44
Chapter 11 Instructions for Use Accessory ..................................................................46
Ordering
.....................................................................................................................50
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PERFUSOR SPACE® OVERVIEW
P E R F U S O R ® S PA C E O V E R V I E W
Arrow up and -down
Scroll through menus, change setting of numbers from
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.
q
Press to reset single values
to zero and switch back to
the previous screen/menu
level.
c
Press to
initiate
bolus.
Yellow LED:
Pre-alarm, reminder alarm
Green / Red LED: Infusion occuring / device alarm,
operating alarm
Blue LED:
Currently connected to SpaceControl
k
m
Open certain functions
and press to confirm
values/settings/alarms.
Press to link the pump to
SpaceControl and to assign
a barcode after scanning.
Drive head with
claws to hold the
syringe plunger
plate and
emergency
release button.
Press to turn
pump on/off.
B o
n
f
S
Press to Start/Stop
infusion.
Syringe holder locks syringe
in position. The drive will
automatically move back.
Cover of Battery Compartment
Before changing the battery, always disconnect the pump from the patient and switch off the device.
To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover
away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange.
Port P3 for future options
3
Port P2 for power supply, SpaceStation,
connection lead (12V), combi lead and
further accessory leads (staff call, service)
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PERFUSOR® SPACE OVERVIEW
Syringe Fixation
Pull and turn the syringe holder to the right
to open the green axial fixation (see red
arrow). Syringe must be fixed with wings
upright in the slot (found to the left hand
side of the axial fixation) before closing
syringe holder. Make sure that syringe is
properly inserted.
Caution: Don't touch piston brake when
moving forward.
Fixaton of PoleClamp (Universal Clamp)
Line up bar of pump with bar of PoleClamp
and slide PoleClamp forward until locking
mechanism clicks.
To remove, press release button on frame,
push handle down and pull PoleClamp
backwards.
Transport
A maximum of three pumps (Perfusor®
Space or Infusomat® Space) plus one
SpaceControl may be stacked together (in
ambulance cars or helicopters only one
pump). Avoid external mechanical influence.
Locking Devices Together
Line up the bar of the lower pump with the
bar of the pump above and slide the lower
pump backwards until the lock clicks and
the green buttons are above each other.
To disconnect, push green locking buttons
of top pump device and slide bottom pump
forward.
Pole Fixation
Push the opening of PoleClamp against the
vertical pole and lock the screw tightly.
Unscrew to release.
For vertical fixation of PoleClamp push
lever down and rotate either way until lever
clicks into notch. Push lever for rotation.
Caution: Do not lean on pump when
attached to pole!
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PATIENT SAFETY
PAT I E N T S A F E T Y
w
Intended use
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is
Read Instructions
for Use prior to use. intended for use on adults, pediatrics, and neonates for the intermittent or conThe infusion device tinuous delivery of parenteral and enteral fluids through clinically accepted
routes of administration. These routes include, but are not limited to intrashould only be
venous, intra-arterial, subcutaneous, epidural, and enteral. The system is used
used by specially
trained staff.
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:
Weight [kg]
Height [cm]
Age [Yrs]
Minimum
30
130
16
Maximum
200
220
100
Some parameter sets are using the Lean Body Mass (LBM) to individualize the
parameterization. The LBM calculation may furthermore restrict the scope of
patients as it will not allow TCI for obese patients.
Using TCI the scope of procedures is:
• Propofol:
Anaesthesia and Conscious Sedation
• Remifentanil: Anaesthesia
The medical specialist must decide on suitability for application on the basis of
the warranted properties and the technical data.
For further details please refer to the Instructions for Use.
Operation
• The initial training of the Perfusor® Space is to be performed by B. Braun
sales personnel or other authorized persons.
After each software update, the user is required to inform himself of the
changes to the device and accessories by referring to the Instructions for Use.
• Ensure the unit is properly positioned and secured. Do not position pump
unit above patient.
• Prior to administration, visibly inspect the pump and the accessories
(especially the axial fixation) for damage, missing parts or contamination and
check audible and visible alarms during selftest.
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PATIENT SAFETY
• Only connect to patient once the syringe has been inserted correctly and
there is proper fixation of the syringe pressure plate by the claws of the drive
head. Interrupt connection during syringe change to prevent incorrect dose
delivery.
• Select syringe/catheter suitable for use with the intended medical application.
• Position the infusion line free of kinks.
• Recommended change of disposable each 24 h (or as per national hygiene
regulations).
• Installation in medically used rooms must comply with the appropriate
regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national
specifications and deviations.
• Do not operate the pump in the presence of flammable anaesthetics to
prevent explosion.
• Compare the displayed value with the entered value. Start infusion only if
the values are corresponding.
• If staff call is used we recommend checking the equipment once after
connecting the pump.
• Protect the device and the power supply against moisture.
• Do not carry the pump device by it's drive mechanism during transportation.
• If the pump device falls or is exposed to force it needs to be examined by the
service department.
• The displayed data must always be checked by the user prior to making
further medical decisions.
• During mobile use (homecare, patient transport inside and outside the
hospital): Make sure the device is securely fixed and positioned. Positioning
changes and severe shock can lead to minor changes in the delivery
accuracy.
• A supplemental patient monitoring must be carried out if life-saving
medication is performed.
• Avoid applying external force on the drive mechanism during administration.
• In case high potent drugs are given be sure to have a second infusion pump
for that drug at hand.
• 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.
Other components
• Only use pressure resistant tubes (min. 2 bar/1500 mmHg).
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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/ENspecifications (e.g. IEC/EN 60950 for data-processing equipment).
The user/operator is responsible for the system configuration if additional
equipment is connected. The international standard IEC/EN 60601-1-1 has to
be taken into account.
Safety Standards
Perfusor® Space satisfies all safety standards for medical electrical devices in
compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24.
• The EMC-limits (electro-magnetic compatibility) according to
IEC/EN 60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment
is operated in the vicinity of other equipment which may cause high levels of
interference (e.g. HF surgical equipment, nuclear spin tomography units,
mobile telephones etc.) maintain the recommended protective distances from
these devices.
• The Perfusor® Space fulfils the applicable requirements of EN 13718 to be
used in the air, on the water and in difficult terrain. During transport the
Perfusor® Space needs to be fixed on a suitable restraint system by means of
SpaceStation or Pole Clamp SP. When stored under temperature conditions
beyond the defined operating conditions the Perfusor® Space needs to
remain under room temperature at least one hour before usage.
Safety Instructions for using PCA
• In case the demand button is used with SpaceStation the PCA pump has to
be placed in the lowest slot of the lowest SpaceStation.
• Access to the pump settings can be prohibited by DataLock 3. The code for
DataLock level 3 should differ from the one for levels 1 and 2 in case the
pump is only allowed to be used by pain management professionals.
• For additional safety the removal of the syringe can be prevented by the use
of the Syringe Anti Removal Cap (see accessories) and the locking of the
syringe holder. The Syringe Anti Removal Cap is usable for the following
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
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PATIENT SAFETY
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 predefined doses by drug list and pump settings.
Safety instructions for using TCI
• TCI should only be performed by experienced anaesthetists being familiar
with the principles of TCI and properly trained in using the present device.
• The use of TCI with B. Braun Space does not limit the responsibility of the
anaesthetist for administration of drugs. They need to be fully aware of the
available literature for any parameter set used in association with a drug and
need to refer to the prescribed information for rate and dosing limits.
• Pharmacokinetic and pharmacodynamic interactions among anaesthetic
drugs are known, but are not taken into account into the calculation of the
plasma and effect site concentrations. They have to be taken into account by
the user.
• In particular, the user must be aware that starting the TCI will result in the
automatic infusion of a pre-calculated bolus dose followed by an infusion to
achieve the selected target concentration.
• It is essential that the user verifies that the patient characteristics and the
selected target concentration as well as the resulting dosages conform to the
prescribing information of the relevant country.
• B. Braun has verified the accuracy of the mathematical model
implementation, the usability as well as pump delivery accuracy.
• While using TCI an appropriate patient monitoring is mandatory.
• Take care of using the right dilution/concentration of the drug and make sure
the right dilution is selected at the pump.
• Never administer Propofol or Remifentanil by a second infusion as long as
you use TCI.
• It is possible to completely switch off the TCI mode to avoid the use of TCI
accidentally.
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MENU STRUCTURE / NAVIGATION
MENU STRUCTURE / NAVIGATION
Cutline
o
f
s
b
n
C
On/Off button
Start/Stop button
K OK button
Q Keypad with arrow up, -down,
-left, -right button
Bolus button
m Connection button
Clear button
All display screen shots are examples and may be different when related to an
individual patient and individualized therapy.
Display
Meaning
At the top of the screen the last therapy is
indicated. Yes/No question can be
answered by pressing u for yes or d
for no.
Parameters which can be changed (e.g.
rate in ml/h) are opened with l or
k. When editing parameters, switch
digits/levels using l r. White
background indicates current
digit/level. Use u or d to change
current setting. Help text on the
bottom/top of the screen indicates
options how to proceed (e.g. confirm
rate with k, start infusion with s
f
or clear rate by pressing c).
Typical display during infusion:
Mains
connection
Battery
status
Set pressure limit and
current pressure
Therapy profile
Active VTBI- or time preselection
Scrolling arrows indicate pump is infusing
Set rate can be opened with l
Unit of drug application
Total volume infused. Alternatively the intermediate volume can be displayed.
Remaining time
Remaining VTBI
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MENU STRUCTURE / NAVIGATION
Display
Meaning
All status information is available in the
bottom line of the dislplay. The desired
information can be selected by using d
u and will be displayed permanently
thereafter (e. g. drug long name, time until
syringe empty etc.).
n has been pressed while the pump is
b
infusing. Start manual bolus at
1200 ml/h by pressing k (see top of
display) or proceed to set bolus limit
with l (see bottom of display).
This hint pops up if a user tries to edit or
change a parameter by pressing l when
that parameter is unable to be changed.
Set pressure level with l or r and
confirm by pressing k.
Cancel to edit pressure by using c.
Pre-alarms are indicated by the message
on the display (e.g. “Syringe nearly
empty”), an audible tone and a flashing
yellow LED. To confirm a pre-alarm
press k.
In case of an operating alarm (e.g.
"Syringe empty") the infusion stops, an
audible tone sounds and the red LED is
flashing. Confirm alarm by using k.
Confirming does not activate an acoustic
feedback
Press and hold o for 3 sec to turn pump
off. A white bar stretches from left to
right and counts down the 3 sec.
As long there is a syringe inserted the
pump will not turn off but will use standby.
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OPERATION
Chapter 1
OPERATION
1.1 Start of Infusion
• Ensure correct installation of the pump device. If the pump is connected to mains,
the display states information such as the battery status, the mains connection
symbol and the last therapy.
• Press o to switch on unit. Note the automatic selfcheck: “Selftest active” and the
software version are displayed, two audible tones sound and all three LEDs (yellow,
green/red and blue) flash once. Information on power supply (battery or mains
connection), the set pressure level and the syringe (if syringe already inserted) are
displayed. Hence the drive moves backwards.
The pump offers the possibility to load up to four languages into the pump
(depending on the number of the language specific characters), among which the
user can choose during the operation of the pump. During the first ever start-up of
the device, the user is requested to select the languages and to mark them with l.
After that, the selection has to be confirmed by choosing the last menu item at the
bottom of the list and pressing k. Then the desired language must be selected with
t and confirmed with k. Answer the following question with d in order to
activate the selected language.
• Press c to start with direct entry of therapy parameters or open pump cover and
syringe holder to start with syringe insertion.
• Insert syringe with wings of the syringe upright in the slot to the right of the
housing. Close syringe holder and pump door. Piston brake moves forward.
Caution: Never leave the pump unattended during syringe loading.
• Confirm syringe type with k. Type of syringe indicated must coincide with syringe
inserted.
• Drive will advance and grip pressure plate of syringe.
Caution: Keep hands away from advancing drive.
Note: Make sure that the piston brake moves back into the syringe holder.
• If the prime function is activated, press U to prime infusion set at 1200 ml/h
(pressing key once = 1 ml). Interrupt prime function with k. Repeat procedure
until infusion line is fully primed. Then press d to proceed.
• Connect with patient.
• Respectively answer questions in Start Up Menu with u and d, until the rate is
displayed in the Main Menu.
Enter infusion rate:
• Press l and set rate using q.
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OPERATION
Chapter 1
• Press s
f to commence infusion. Running arrows on display and green LED
above display indicate pump is infusing.
Note: Stop the infusion at any time by pressing s
f. The pump can be turned off
at any time by pressing o for 3 sec (Exception: Data lock level 2) and as long a
disposable is inserted.
1.2 Entry With Different Combinations of Rate, VTBI
(= Volume To Be Infused) and Time
The Perfusor® Space offers the possibility to enter a volume- and time limit in addition
to an infusion rate. When two of these parameters are entered, the third is calculated
by the pump. If a volume and/or time is preselected, an arrow symbol is placed in front
of one of these parameters in the Main Menu. It is called the “target”. During the
infusion of the pump, this target symbol is displayed next to the moving arrows in the
run display (this symbol is not visible in case TCI is used). This indicates that the pump
has been programmed, either with a volume- or time limit. The assignment of the 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 Main Menu and the run display (values are counting down).
1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the
bottom of the display.
Target: Volume
• Select VTBI with t and open with l.
• Enter VTBI with q and confirm with k.
• Select time with t and open with l.
• Enter time with q and confirm with k.
Check calculated rate on plausibility.
Proceed in the same way to calculate 2.) and 3.).
2.) Infusion with volume limit
Enter rate and VTBI: The infusion time will be calculated and displayed at the
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):
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OPERATION
Chapter 1
a) Target symbol is placed in front of VTBI:
• Change of VTBI => Adjustment of time. Old and new target: VTBI
• Change of time => Adjustment of rate. Old and new target: VTBI
b) Target symbol is placed in front of time:
• Change of time => Adjustment of VTBI. Old and new target: Time
• Change of VTBI => Adjustment of time. New target: VTBI
Note: Changing VTBI/time is only possible while the pump has been stopped.
1.3 Bolus Application
There are three ways to administer a bolus:
1.) Manual Bolus: Press n
b. Then press k and hold button. Fluid is
administered as long as button is held down. The infused bolus volume is
displayed.
The max. bolus volume is limited to 10 % of the syringe size or 10 sec.
Reaching this limit is indicated by an acoustic signal.
2.) Bolus with volume preselection: Press n
b. Then press l and set bolus dose
limit by using q. Press n
b to confirm and start bolus. Depending on the
service tool settings an acoustic signal will sound after finishing the bolus
volume.
3.) Bolus with rate calculation: Press n
b. Then press l and set bolus dose
by using q. Press k to confirm bolus dose. Set time with q in which a
bolus is to be delivered. Calculated bolus rate is shown on top of the display.
Press n
b to confirm and start bolus.
After pressing the button n
b the bolus unit can be selected by using d. The
selected unit will be stored and offered as default later on. By this also in dose
mode it is possible to administer a bolus in ml.
You can use the service program to enter a default and a maximum bolus rate.
Once a new therapy is started the device always returns to the default rate
- even if the bolus rate was manually changed beforehand.
Note: If the bolus limit is not entered after pressing n
b, the pump switches
back into the run display automatically.
Note: The infused volume during bolus with volume preselection counts up.
In order to purge the line at any time while the pump is stopped press n
b.
Answer the following question by pressing u in order to start the purge
process. Cancel by pressing u or any other key.
Caution: Take care not to overdose! Given a bolus rate of 1200 ml/h, 1 ml will
be administered in just 3 sec. To cancel bolus infusion at any time press k.
At low bolus volumes, under dosages due to the start up characteristic of the
pump and the tolerances in the infusion system cannot be excluded. Disconnect
patient while purging.
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OPERATION
Chapter 1
1.4 Syringe Change and New Therapy Start
Note: To avoid incorrect dosing, always disconnect the pump from the patient when
changing the syringe. Never leave the pump device unattended during syringe change.
Before inserting a new syringe check if the axial fixation is properly working.
• Press s
f to stop the infusion. The green LED will disappear.
Disconnect the pump from the patient.
• Open syringe holder. Drive mechanism moves backwards into starting position. If
the syringe holder is being opened more than 30 sec after the pump was stopped
the question if a syringe change should be performed must first be answered with
u before the drive moves backwards (regardless of the time this always applies in
case of a syringe holder alarm). If a syringe holder is pulled just shortly (less than
one second) the displayed question must first be answered by pressing u to
initiate the release of the syringe plunger.
• Open pump door, remove syringe and insert new syringe.
Note: In case the plunger head of the syringe is not released anymore by the claws
when performing a syringe change, the emergency release button needs to be pressed
to release the claws of the drive head. The emergency release button is placed on the
outside of the drive head. It can be released with a pointed pen. Then manually open
the claws and take out the syringe.
• Close the syringe holder (Note: Piston brake must move forward!) and the pump
door and confirm the inserted syringe type with k. Drive advances and grips
pressure plate of syringe.
Note: Do not block advancing drive unit with any objects. Piston brake must move
backwards into the syringe holder.
• Prime pump if necessary with u then press d to continue.
• Connect the patient to the pump and check set parameters using t.
• Press s
f to start infusion.
To start a new therapy after a syringe change:
• Press c when pump is in the Main Menu.
• Press d and continue to set new therapy parameters with q.
• Press s
f to start infusion.
Note: A new therapy can be started at any time during a stopped infusion. Press
c (repeatedly) when the pump is in the Main-, Status- or Options Menu and
proceed to follow instructions as described.
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OPERATION
Chapter 1
1.5 End of Infusion
• Press s
f to stop the infusion. The green LED disappears. Disconnect the
pump from the patient.
• Open the syringe holder. Answer the question whether a syringe change should be
performed with u. The drive moves backwards into the starting position.
• Open pump cover. Remove the syringe, move the syringe holder into an upright
position and close the front door.
• Press o for 3 sec. to switch the pump off. The drive moves into parking
position.
Note: The settings will be permanently saved by the switched off device.
As long as a disposable is inserted the pump will use standby.
1.6 Standby Mode
In the case of extended interruption, the user has the option to maintain the set values.
• Press s
f to stop the infusion. Then press o for less than 3 sec.
• Confirm that the pump is supposed to switch into standby by pressing u.
• The pump is now in Standby.
=> While the pump is in the standby mode, it’s display shows the drug and the
remaining time for this mode. Change of remaining time by pressing l.
Exit standby by pressing c .
As long as a disposable is inserted in the pump will use standby also in case o is
pressed for at least or more than 3 sec.
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ADVANCED OPERATIONS
Chapter 2
ADVANCED OPERATIONS
2.1 Status Request of Pump when Infusion is Running
Press c to switch between run display and Main Menu while the device is infusing.
Navigate through the menu using t to check parameters. In order to check the menu
parameters in the Status-/Options Menu, select "Status" respectively "Options" in the
Main Menu, open menu with l and scroll through menu with t.
2.2 Rate, VTBI and Time Change Without Infusion
Interruption and Reset of Status Menu Data
• Press c when the pump is in the run display in order to switch to the Main Menu.
Select rate/VTBI/time with t and press l in order to open the parameter.
• Enter new value with q and confirm with k.
Reset Status Menu Data:
The parameters intermediate volume and -time can be reset when the pump is
infusing or when the pump is stopped.
• Select “Status” in Main Menu with t and press l.
• Highlight intermediate volume (in ml) or intermediate time (in h:min) with t and
open parameter with l.
• Reset values by pressing u.
Both parameter total volume and -time, are displayed in the pump as "Total" with the
according unit and can be reset by starting a new therapy. A second way to reset the
parameters when the pump is in the Main Menu: Press c, answer question if the last
therapy is to be used with u and reset the values with u.
The type of the inserted syringe is displayed in menu item „Syringe“ and cannot be
changed once it has been confirmed at the beginning of the infusion. The drug info
states the drug name, the name of the drug list and its date of origin. The current
battery capacity in hours and minutes is displayed in the menu item “Battery Cap.” and
the current software version in menu item "Version".
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SPECIAL FUNCTIONS
Chapter 3
SPECIAL FUNCTIONS
3.1 Dose Rate Calculation (Overview)
The dose rate calculation enables a calculation of the rate in ml/h from the entered
dose parameters.
Infusion rate [ml/h] =
Dose
x Patient weight (optional)
Concentration
[
]
Setting parameters:
1. Concentration as the amount of the active ingredient per volume.
- Amount of the active ingredient in µg, mg, mmol, IU or mEq.
- Volume in ml.
2. Where necessary: Patient weight in kg or lbs.
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.
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 u for a time and weight related calculation, set the patient
weight with q and confirm it with k.
a Select the dose prescription with t and confirm it with l.
a Set the dose with q and confirm with k. The rate will automatically
be calculated and displayed at the bottom of the display.
a Check the calculated rate and if necessary the adapted parameters with
t on plausibility before starting the infusion with s
f.
Concentration and dose can later be changed in the Main Menu in the
same way as the rate, VTBI and time (compare 2.2). The effect of dose
modifications on other parameters is shown at the bottom of the display.
Additionally the total and intermediate amount of the infused drug can be
taken from the Status Menu. These can be checked and resetted in the same
way as the other total and intermediate values.
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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 will alter the flow rate.
Following user requests, the parameter sequence in the main menu was
changed in software version G differing from version F. In dose mode, the dose
rate is displayed before the delivery rate. The cursor is placed on the dose rate.
This must be pointed out during first start-up and/or instruction of new users.
3.3 Drug Library
Up to 1500 drug names including therapy data and information can be stored in
15 categories. The loading process into the pump can be performed via a
separate PC program („Drug List Editor Space“).
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 drug
library (see headline) will be displayed on the pump.
There are different ways of embedding the drug library into the therapy. This
can be done while the infusion is running or when the pump is stopped.
On the one hand, a drug name including the according therapy data can be
taken from the drug library. On the other hand, if a rate, VTBI and/or time were
already defined in the Main Menu, the drug name and the adjusted values of
the data set will be loaded. If a dose rate calculation has already been started a
belated assignment of the drug name nevertheless is possible.
In the following the loading of a drug including the according parameters will
be described:
•
Open the drug library by pressing l.
•
Navigate through list with t and select the drug from category in
alphabetical order (all drugs) or within a category with l.
•
Respectively confirm the displayed drug information with l.
•
Check if the drug short name in the Main Menu is the same as the selected
drug. Check the parameter in the Main Menu with t and start infusion
with s
f.
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.
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Chapter 3
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.
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.
After the selection the pump
offers additional drug related
Information which are confirmed
by l.
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Chapter 3
Select profile PCA by using and
confirm with t .The therapy settings stored in the drug list are
displayed *.
The therapy can be started now with s
f in case all values are defined.
Depending on the pre-defined settings the therapy is started with an initial
bolus and a basal rate or not.
Before leaving the patient the pump should be put into DataLock level 3 with
q in Menu “Options”. This is necessary especially in case non-authorised access
to the settings can be anticipated.
The code is entered with q and confirmed with k.
The pump display now may look
like this.
In this state the patient is allowed to demand boli. Depending on the status of
the therapy these are either administered or denied. Changing the syringe is also
possible by using the code for level 1 or level 2. Altering the settings for PCA or
other therapies however is only possible with the code for level 3.
The status of the therapy can be checked in the menu „Status“ .
Enter the „Main Menu“ with c and select the “Status“ with q.
The A/D-ratio indicates the
percentage of administered and
demanded boli thus giving an idea
about the effectivity of the
therapy.
An acoustic confirmation of demanded boli can be activated and modulated by
t in Data Lock 3.
Is a demand button connected, the therapy symbol looks like this:
In case there is no demand button connected the therapy symbol looks like
this:
.
The demand button is connected to the interface P2 at the rear side of the
pump.
*Bolus volume is the volume of a single bolus the patient may demand. Max. Limit is the amount of
drug or volume a patient may demand within a certain time in total. Lockout is the time in between
two boli.
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Chapter 3
Hint: It is possible to start a therapy in continuous mode and switch over to
PCA later on (in case the drug is dedicated for use with continuous and PCA
application).
3.5 Target Controlled Infusion (TCI)
Introduction
In TCI the user is defining a desired concentration of drug in the human body
(target) rather than an infusion rate. The rates necessary to reach and maintain
that said concentration are calculated by the pump using an algorithm based on
a three-compartment pharmacokinetic model.
A pharmacokinetic model (PK model) is a mathematic model to predict the 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:
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B. Braun Space is offering two modes for TCI:
• TCI by targeting the plasma concentration
In this mode the user selects the desired concentration of a drug in the blood
plasma and the PK model is used to calculate the infusion rates required to
achieve that concentration as quick as possible (unless there is no restriction
defined by the user).
• TCI by targeting the effect-site concentration
In this mode the user selects the desired concentration of a drug at the site
of action and the PK model is used to calculate the infusion rates required to
achieve that concentration as quick as possible (unless there is no restriction
defined by the user). A certain overshoot of the concentration in the plasma
is resulting from this mode.
For effect-site targeting there is a link between pharmacokinetics and pharmacodynamics necessary. As the effect-site compartment is considered to have no
volume and the rate constant k1e can be ignored the rate constant ke0 is the
parameter necessary to perform effect-site TCI. A pharmacokinetic model modified in such way is schematically depicted by the illustration on the next page.
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Chapter 3
TCI with B. Braun Space is possible with two drugs: Propofol and Remifentanil.
For Propofol the user can choose between two parameter sets. The parameter
sets used for these drugs are (Not all parameter sets allow effect-site targeting):
Drug / Parameter
V1 [Litre]
0,228 * Weight
Propofol
4,27
k10 [min-1]
0,119
0,443 + 0,0107 * (Weight 77) - 0,0159 * (LBM - 59) +
0,0062 * (Height - 177)
k12 [min-1]
0,112
0,302 - 0,0056 * (Age - 53)
k13 [min-1]
0,0419
0,196
k21 [min-1]
0,055
[1,29 - 0,024 * (Age - 53)] /
[18,9 - 0,391 * (Age - 53)
k31 [min-1]
0,0033
0,0035
ke0 [min-1]
Reference
0,26
Marsh et al., Br. J.
Anaesthesia, Vol.
67, 1991, 41-48
Effect-site
targeting
No
0,456
Schnider et al., Anesthesiology, Vol. 88, 1998, 11701182 Schnider et al.,
Anesthesiology, Vol. 90,
1999, 1502-1516
Yes
Yes
Remifentanil
5,1 - 0,0201 * (Age - 40) +
0,072 * (LBM - 55)
[2,6 - 0,0162 * (Age - 40) +
0,0191 * (LBM - 55)] / [5.1 0.0201 * (Age - 40) + 0.072 *
(LBM - 55)]
[2,05 - 0,0301 * (Age - 40)] /
[5.1 - 0.0201 * (Age - 40) +
0.072 * (LBM - 55)]
[0,076 - 0,00113 * (Age - 40)] /
[5.1 - 0.0201 * (Age - 40) +
0.072 * (LBM - 55)]
[2,05 - 0,0301 * (Age - 40)] /
[9,82 - 0,0811 * (Age - 40) +
0,108 * (LBM - 55)]
0.01402 - 0,0002085 *
(Age -40)
0,595 - 0,007 * (Age - 40)
Minto et al., Anesthesiology,
Vol. 86, 1997, 10-33
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Drug List
The pre-installed drug list offers the following values:
Available Concentrations
Short name
Default Max. Rate
Hard Limit Rate
Plasma Limit Default
Plasma Limit Hard Low
Plasma Limit Soft Max
Default Target
Target Soft Max
Target Hard Max
Decrement Concentration
Default
Default Parameter Set
Propofol
5 mg/ml
10 mg/ml
20 mg/ml
TCIProp
1.200 ml/h
Max of pump
400 %
100 %
450 %
0.0 µg/ml
8.0 µg/ml
15.0 µg/ml
1.0 µg/ml
Marsh
Remifentanil
20 µg/ml
50 µg/ml
TCIRemi
1.200 ml/h
Max of pump
400 %
100 %
450 %
0.0 ng/ml
8.0 ng/ml
20.0 ng/ml
1.0 ng/ml
Minto
Important note: Before installing an additional drug list please contact your local
B. Braun representative!
Setting up the pump
For TCI a drug list with at least one drug activating the profile TCI is necessary. The
drug list in this version is pre-defined. By this the conditions for an effective and safe
therapy are defined.
Switch on pump with o and wait until self-check is finished. Insert disposable and
use the drug lib according to Instructions for Use.
Selecting a drug
Select drug list, category (the TCI drugs need to be selected from the category “TCI”)
and desired drug by using q .
In this example: Propofol.
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As a next step select the correct
dilution (concentration) of the drug
to be administered as well as the
parameter set (model) and the Mode
(Effect-Site Targeting or Plasma
Targeting)
These steps are only necessary in case there are different options for that drug.
Input of patient data
Depending on the parameter set one or more of the following data are necessary:
•
•
•
•
Weight
Height
Gender
Age
Use q for editing the patient data.
Example.
The editing window appears with the initial setting “0” to make sure editing a value
takes place (exemption: initial setting for gender is “male”).
Using effect-site targeting the weight may be limited due to the constraints of the
LBM calculation.
Important notes:
•
•
Be sure to enter the data corresponding to the respective patient.
Once the TCI is started patient data can not be altered!
Editing a target and starting TCI
The editor window for setting the target comes up with the default value from the
drug list.
Editing this parameter is guided by
the dose error reduction system
“DoseGuard™” according to the limits
defined in the drug list.
25