infusomat_space_instructions_for_use_sw_686m.pdf
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Infusomat® Space
and Accessories
Instructions for Use
It is recommended that all pumps at
your care unit are equipped with the
same software version.
GB
Valid for software 686M
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CONTENTS
Infusomat® 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........................................................................................................................................16
1.3 Bolus Application .......................................................................................................................17
1.4 Infusion Line Change and New Therapy Start...................................................................18
1.5 End of Infusion............................................................................................................................20
1.6 Standby Mode .............................................................................................................................20
Chapter 2
Advanced Operations ....................................................................................21
2.1 Status Request of Pump when Infusion is Running ........................................................21
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data.................................................................................................................21
Chapter 3
Special Functions*..........................................................................................22
3.1 Dosing Units and Dose Rate Calculation (Overview).......................................................22
3.2 Dose Rate Calculation (Operation)........................................................................................22
3.3 Drug Library..................................................................................................................................23
3.4 Patient Controlled Analgesia (PCA) (optional) ..................................................................26
3.5 Target Controlled Infusion (TCI) (optional).........................................................................27
3.6 Barcoding......................................................................................................................................33
3.7 Piggyback Function....................................................................................................................34
3.8 Ramp and Taper Mode..............................................................................................................36
3.9 Program Mode.............................................................................................................................39
3.10 Intermittent Mode.....................................................................................................................40
3.11 Dose Over Time ...........................................................................................................................43
Chapter 4
Chapter 5
Autoprogramming..........................................................................................45
Options ..............................................................................................................49
5.1 Occlusion Pressure .....................................................................................................................49
5.2 Upstream Occlusion Pressure .................................................................................................49
5.3 Data Lock ......................................................................................................................................49
5.4 Bolus Rate.....................................................................................................................................50
5.5 KVO-Mode ....................................................................................................................................51
5.6 Contrast / Display Light / Keypad Light...............................................................................51
5.7 Alarm Volume ..............................................................................................................................51
5.8 Date / Time ...................................................................................................................................51
5.9 Macro Mode.................................................................................................................................51
5.10 Language.......................................................................................................................................52
Chapter 6
Alarms................................................................................................................53
6.1
6.2
6.3
6.4
*The availability of
the listed features
is depending on
the configuration
of the pump.
**Technical Safety
Check.
Chapter 7
Chapter 8
Chapter 9
Chapter 10
Chapter 11
Ordering
Device Alarms..............................................................................................................................53
Pre-Alarms and Operating Alarms ........................................................................................53
Reminder Alarms ........................................................................................................................56
Alarm Hints ..................................................................................................................................56
Battery Operation and Maintenance .......................................................57
Start Up Graphs and Trumpet Curves ......................................................59
Technical Data.................................................................................................60
Warranty / Training / TSC** / Service / Disinfecting / Disposal ......67
Instructions for Use Accessory ...................................................................71
......................................................................................................................76
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INFUSOMAT SPACE® OVERVIEW
I N F U S O M AT ® 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.
Press to reset single values
to zero and switch back to
the previous screen/menu
level.
Press to
initiate
bolus.
Pre-alarm, reminder alarm
Infusing
Operating or device alarm
Initiating connection to wireless
battery or Space Station
k
Open certain functions
and press to confirm
values/settings/alarms.
m
Press to initiate
auto-programming
orders when prompted.
x
c
q
Yellow LED:
Green LED:
Red LED:
Blue LED:
Press to
open the
pump door.
Press to turn
pump on/off.
B
n o
f
S
Press to Start/Stop
infusion.
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.
A crank in order to open the pump door in case of emergency is attached to the inside of the battery compartment
cover (for closer information see 1.4).
Port for drop sensor
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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INFUSOMAT® SPACE OVERVIEW
Downstream
pressure sensor
Air
sensor
Opening lever
Pump based free flow
prevention safety clamp
Pole clamp handle
Pole clamp
release button
Pump slots
Yellow
caution light
Line guide
cover
Upstream
pressure sensor
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 (Infusomat®
Space or Perfusor® Space) plus one
SpaceControl may be stacked together (in
ambulance cars and 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.
4
Pole Fixation
Push the opening of the 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!
Caution: A maximum of three B. Braun
Space pumps can be stacked together
when used with the PoleClamp SP.
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SYMBOLS ON PRODUCT
SYMBOLS ON PRODUCT
Symbol
Explanation
Mandatory action: see instruction for use.
See accompanying documents.
Type CF unit with defibrillation protection
Protection class II device
Symbol indicating separate collection for electrical and
electronic equipment (2002/96/EC)
CE mark compliant to Directive 93/42/EEC
Temperature Limit
Moisture Limit
Limitation of the atmospheric pressure
Non-ionizing electromagnetic radiation
General warning sign (e.g. Caution)
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PATIENT SAFETY
PAT I E N T S A F E T Y
w
Intended use
The Infusomat® Space Volumetric Infusion Pump System includes an external
transportable electronic volumetric infusion pump, dedicated administration
Read Instructions
sets, and pump accessories. The system is intended for use on adults, pediatrics,
for Use prior to use.
and neonates for the intermittent or continuous delivery of parenteral and
The infusion device
enteral fluids through clinically accepted routes of administration. These routes
should only be
include,
but are not limited to intravenous, irrigation/ablation, and enteral. The
used by specially
system is used for the delivery of medications indicated for infusion therapy
trained staff.
including but not limited to colloids and cristalloids, blood and blood
components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The
Infusomat® Space Volumetric Infusion 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
Qualified medical staff should decide how the device should be used based on
its features and specifications. For more details, please read the Instructions for
Use.
Operation
• The initial training of the Infusomat® 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 about the changes to the device and
accessories in the instructions for use.
w Caution: Ensure the unit is properly positioned and secured. Do not position
4
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 for damage, missing parts or
contamination and check audible and visible alarms during selftest.
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• Not be used adjacent and stacked with other equipment except B. Braun
Space devices.
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PATIENT SAFETY
• Only connect to patient once the line has been correctly inserted and
completley primed. Interrupt connection during line change to prevent
incorrect dose delivery.
• Select infusion line/catheter suitable for use with the intended medical
application.
w Caution: Position the infusion line free of kinks.
4
• Recommended change of disposable every 96 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.
w Caution: Operate the pump at least 25 cm from flammable anaesthetics to
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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.
• If the pump falls down or is exposed to force, it must be checked 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.
• The air detector cannot detect air diffusing in the following components:
three-way stopcocks, infusion adapters and further lines placed between
pump and patient.
• 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 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.
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PATIENT SAFETY
Enteral Nutrition
The Infusomat® 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.
Transfusion
The Infusomat® Space may be used for blood transfusion, too. For this therapy
only use disposables dedicated and labelled for transfusion.
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 respective 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.
• 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
Infusomat® 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 distances recommended by the manufacturers of these devices.
• The Infusomat® Space fulfils the applicable requirements of EN 13718 to be
used in the air, on the water and in difficult terrain. During transport the
Infusomat® 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 Infusomat® Space needs to
remain under room temperature at least one hour before usage.
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PATIENT SAFETY
• As there is no dedicated norm existing for enteral feeding pumps the safety
features of Infusomat Space are also for enteral nutrition according to the
a.m. norms.
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.
• 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.
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PATIENT SAFETY
• It is possible to completely switch off the TCI mode to avoid the use of TCI
accidentally.
• By using Infusomat® Space a change of drug concentration will not be
possible within the same therapy.
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.
Underside view
Clamp grids
W
• DO NOT use any Pole Clamp that
shows signs of damage.
• DO NOT use Pole Clamp with
missing clamp grids.
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MENU STRUCTURE / NAVIGATION
MENU STRUCTURE / NAVIGATION
Cutline
o
x
f
s
b
n
On/Off button
Door open button
Start/Stop button
C Clear button
K OK button
Q Keypad with arrow up, -down,
-left, -right button
Bolus button
m Connection 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 f
s 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 display. The desired
information can be selected by using d
u and will be displayed permanently
thereafter (e. g. drug long name, current
system pressure etc.).
b
n 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).
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 a message on
the display (e.g. “VTBI near end”), 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. "VTBI
infused") the infusion stops, an audible
tone sounds and the red LED flashes.
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 an infusion line inserted
the pump will not turn off but will use
standby.
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MENU STRUCTURE / NAVIGATION
Start Up
Menu
Main
Menu
Special
Functions
Options
Menu
Status
Menu
Line
selection
Dose
Dose Rate
Calculation
Occlusion
Pressure
Intermediate
volume
Prime ?
Concentration
Drug Library
Data Lock
Intermediate
amount
Use last
therapy ?
Weight
Change-over
from
continuous
mode to PCA
Bolus
Rate
Intermediate
time
Use drug
library ?
Rate
KVOMode
Total
volume
Use dose rate
calculation ?
VTBI
Contrast
Total
amount
Time
Display
Light
Total
time
Special
Functions
Keypad
Light
Line
Options
Alarm
Volume
Battery
capacity
Status
Date
WLan
Time
Version
Macro
Mode
Drug
info
In Dose Mode:
Display of flow
rate in large
scale
Language
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OPERATION
Chapter 1
OPERATION
1.1 Start of Infusion
• Ensure that the pump is properly installed. Check the equipment for completeness
and damages. Do not attach the infusion bottle below the pump level.
• Put the spike vertically into the infusion bottle. Fill the bottom part of the drop
chamber by max. 2/3.
w Caution: Close the roller clamp before inserting the IV line and do not
4
connect to
patient until properly loaded and primed.
• If the device is connected to the mains, the display indicates the battery status, the
mains connection symbol and the last therapy.
• Press o to switch on the device. Observe the automatic self-test: The message
“Self-test active” and the software version are displayed, two audible tones sound
and all three LEDs (yellow, green/red and blue) flash once. Information about the
power supply (mains or battery operation) and the set pressure level are indicated.
In addition, the line type appears at first (provided that the line is already inserted).
Then, the accumulated air volume and the max. size of air bubbles is indicated
which is triggering the air alarm of the device.
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 the direct entry of therapy parameters, or press x and u to
open the pump door in order to continue with inserting the line.
w Caution: Close the roller clamp before inserting the IV line and do not
4
connect to patient until properly loaded and primed.
Caution: You may only insert the line while the device is switched on and the line
guide element is inserted. Otherwise, there is the danger of freeflow. Pay attention to
keep the roller clamp closed before inserting the infusion line especially at a temperature scale of 10 - 15 °C. Never leave the pump unattended when inserting the tube.
Caution: Inserting different lines into the pump is identical. Please see instructions and
packaging of the different lines (standard, transfusion, opaque, enterel nutrition etc.)
to receive information about preparation and usage of these lines.
• Firmly press tubing into the air sensor guide to make sure the line is properly
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OPERATION
Chapter 1
Insert the infusion line from right to
the left. Make sure that the line is
routed straight. At first, route the line
through the upstream sensor. Then,
insert the two-hole clip.
Next attach the white clip.
Insure silicone segment is not
stretched or twisted, stars on tubing
must be in straight line and should
not be twisted.
Insert the freeflow clamp (see red
arrow) in the opened aperture, in the
direction indicated by the arrow, until
the opening lever locks in and the
safety clamp squeezes the lines
(flashing signal lamp goes out).
inserted into the sensors. Thread the tubing through the notches on the right and
left side of the pump.
• Close the pump door by firmly placing pressure with both hands on each side of the
pump door, continue to press firmly until you hear and feel the motorized door
latch pull the door shut. Do not open roller clamp until the pump directs you to do
so when self test is completed. Then select the inserted line with t and confirm it
with l. Open the roller clamp.
Caution: Do not force door closed – If door is difficult to close, please check IV set and
anti free-flow slide clamp (green) for proper installation.
Caution: Before opening door, please close roller clamp and ensure door does not fall
open. If door opens to the horizontal position, please check that the slide clamp (green)
is properly occluding the IV set and the door extension hook is not broken. If the door
hook is found damaged or broken remove the pump from service.
Caution: If a wrong line is selected the time until the pump goes into a pressure alarm
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OPERATION
Chapter 1
may be prolonged. Also a wrong delivery rate is possible.
• Press u if the prime function is enabled to prime the infusion line with the rate
displayed. Cancel priming with k. Repeat the procedure until the line is
completely primed. Then press d to proceed.
Note: During priming, all air and drop alarms are switched off.
• Establish the patient connection.
• Answer the question whether the old therapy is to be used either with u or d
(the question can be deactivated via the service manual). If you select u, the
pump jumps to the Main Menu.
Note: At rates smaller 1 ml/h the detection of a closed roller clamp cannot always be
ensured due to physical reasons. A drop sensor may be used to avoid this risk.
Adjusting the delivey rate:
• In the Main Menu, open the rate with l and set it with q.
s to start the infusion. VTBI is required to start the infusion. Time will
• Press f
be calculated when rate is entered. When time is entered, rate/doserate will
be calculated. Running arrows on the display and the green LED indicate that
the pump is infusing.
Note: If Infusomat Space Line SafeSet is used, VTBI is not required.
Note: The running infusion can be cancelled at any time by pressing f
s. 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 Infusomat® 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).
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OPERATION
Chapter 1
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 on the
bottom of the display.
Target: VTBI
3.) Infusion with time limit
Enter rate and time: The infusion volume will be calculated and displayed on 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):
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
1.3 Bolus Application
After pressing the button b
n, 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 b
n. Then press k and hold button. Fluid is
administered for as long as the button is held down.. The infused bolus
volume is displayed.
The max. bolus time is limited to 10 sec.
Reaching this limit is indicated by an acoustic signal.
2.) Bolus with volume preselection: Press b
n. Then press l and set bolus dose
limit by using q. Press b
n to confirm and start bolus. Depending on the
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OPERATION
Chapter 1
service tool settings an acoustic signal will sound after finishing the bolus
volume.
3.) Bolus with rate calculation: Press b
n. 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 b
n 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 b
n, the pump switches
back into the run display automatically.
Note: The infused volume during bolus with volume preselection counts up.
n.
In order to purge the line at any time while the pump is stopped press b
Answer the following question by pressing u in order to start the purge
process. Cancel by pressing k 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.
1.4 Infusion Line Change and New Therapy Start
Note: Always interrupt the patient connection before changing a line to avoid dosing
errors. Never let the pump run unattended when changing the line. Check and clean
the safety clamp regularly.
• Press f
s to stop the delivery. The green LED goes out. Close the roller clamp
and interrupt the patient connection.
• Press x and open the pump door with u. Press down the green opening lever
completely until it locks in place, remove the line and insert a new line.
Note: In the unlikely event the pump door cannot be opened remove the allen key from
the inside of the battery compartment cover. Use this key to remove the
emergency aperture cover of the pump. Place the crank in the aperture and turn it
clockwise until the pump door opens.
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ADVANCED OPERATIONS
Chapter 2
Push cover opening with pen.
Remove crank from inside of
battery cover.
Turn crank to remove emergency
aperture cover.
Remove emergency aperture cover.
Turn crank inside aperture to open
the door.
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OPERATION
Chapter 1
• Close the pump door, confirm the inserted line with k and open the roller clamp.
• If required, prime the pump with u. Then press d to proceed when priming is
complete.
• Establish the patient connection and check the parameters with t.
s.
• Start the infusion by pressing f
Note: A new therapy can be started at any time during a stopped infusion. If the pump
is in the Main, Status or Options Menu, press C (repeatedly) and follow the
instructions as described.
1.5 End of Infusion
• Press f
s to stop the infusion. The green LED goes out. Close the roller clamp
and interrupt the patient connection.
• Press x. Answer the question whether the pump door is to be opened with
u.
• Press down the green opening lever completely until it locks in place.
Remove the line and close the pump door.
• Press o for 3 sec to switch off the pump.
Note: The settings will be permanently saved by the switched off device.
Note: Pump cannot be powered off with IV line inserted.
1.6 Standby Mode
In the case of extended interruption, the user has the option to maintain the set values.
s to stop the infusion. Then press o for less than 3 sec.
• Press f
• Confirm that the pump is supposed to switch to 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, standby may be set from 1 min to 24 hours. Change of remaining
time by pressing l. Exit standby by pressing c . The pump will alarm when the
standby time expires.
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 has 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 the question
whether the last therapy is to be used with u and reset the values with u.
The type of the inserted line is displayed in menu item „Line“ 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. If the change from the
secondary to the primary infusion will be performed manually or automatically will be
displayed in line “PGY change”. 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.
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SPECIAL FUNCTIONS
Chapter 3
SPECIAL FUNCTIONS
3.1 Dosing Units and Dose Rate Calculation (Overview)
The following list shows the units used in the pump:
Gram family:
Unit family:
Equivalents family:
Mole family:
Kilocalorie family:
Millitliter family:
ng, mcg, mg, g
mIU, IU, kIU, MIU
mEq
mmol
kcal
ml, ml/kg
In addition to these dosing units the user can choose:
•
•
Feeding: kcal, mEq, mmol
Surface related amount units: m2
Infusion rate [ml/h] =
Dose
x
Concentration
[ Patient weight (optional) ]
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.
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.
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SPECIAL FUNCTIONS
Chapter 3
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's weight does not need to be entered press l.
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 be
automatically 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 f
s.
s.
a Check the parameters with t on plausibility before starting with f
Dose can belatedly 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 reset 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 assigning a drug to an infusion. 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.
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SPECIAL FUNCTIONS
Chapter 3
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
Area" 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
f
s.
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 (incl.
Piggyback mode).
Initial Bolus:
Initial Bolus has to be configured in the Drug List Manager.
24
•
Use the drug library according to the instructions for use.
•
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.
•
s.
Check the parameter and start infusion with f
Page 25
SPECIAL FUNCTIONS
Chapter 3
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.
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.
25