Braun Perfusor Space User manual

Perfusor® Space
and Accessories
Instructions for Use
Valid for Software 688F
Rx only
Please make sure all pumps on your
ward are equipped with the same
software version.
951092 Rev C (03/08)

CONTENTS
CONTENTS
Contents ........................................................................................................................2
Perfusor® Space Overview.......................................................................................................3
Patient Safety ........................................................................................................................5
Menu Structure / Overview ....................................................................................................8
Menu Structure / Navigation.................................................................................................9
Chapter 1 Operation..........................................................................................................11
1.1 Start of Infusion .........................................................................................................................11
1.2 Setting ifferent Combinations of Rate, VTBI (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 Request Status of Infusion While Pump Running ...........................................................16
2.2 Rate, VTBI and Time Change Without Infusion
Interruption and Reset of Status Menu ata ..................................................................16
Chapter 3 Special Functions...........................................................................................17
3.1 ose Rate Calculation (Overview) ........................................................................................17
3.2 ose Rate Calculation (Operation) .......................................................................................17
3.3 rug Library.................................................................................................................................18
Chapter 4 Options..............................................................................................................20
4.1 Occlusion Pressure.....................................................................................................................20
4.2 ata Lock......................................................................................................................................20
4.3 Bolus Rate ....................................................................................................................................21
4.4 KVO-Mode....................................................................................................................................21
4.5 Contrast / isplay Light / Keypad Light ..............................................................................21
4.6 Alarm Volume..............................................................................................................................21
4.7 ate / Time ..................................................................................................................................22
4.8 Macro Mode ( isplay Infusion Rate in Big Numbers) ....................................................22
4.9 Language ......................................................................................................................................22
Chapter 5 Alarms ...............................................................................................................23
5.1 evice Alarms .............................................................................................................................23
5.1 Pre-Alarm and Operating Alarm............................................................................................23
5.3 Reminder Alarms........................................................................................................................26
5.4 Alarm Hints..................................................................................................................................26
Chapter 6 Battery Operation and Maintenance .......................................................27
Chapter 7 Compatible Syringes .....................................................................................29
Chapter 8 Start Up Graphs and Trumpet Curves......................................................30
Chapter 9 Technical ata ................................................................................................31
Chapter 10 TSC* / Service / Training / Cleaning / isposal .....................................33
Chapter 11 Instructions for Use Accessory ..................................................................35
Ordering .....................................................................................................................38
Technical Support....................................................................................................................41
The Perfusor® Space
Infusion Syringe
Pump System in-
cludes an external
transportable elec-
tronic infusion sy-
ringe pump and
pump accessories.
The system is in-
tended for use on
adults, pediatrics,
and neonates for the
intermittent or con-
tinuous delivery of
parenteral and en-
teral fluids through
clinically accepted
routes of adminis-
tration. These routes
include, but are not
limited to intra-
venous, intra-arteri-
al, subcutaneous,
epidural, and enter-
al. The system is used
for the delivery of
medications indicat-
ed for infusion ther-
apy including but
not limited to drugs
like anesthetics,
sedatives, analgesics,
catecholamines, an-
ticoagulants etc.;
blood and blood
components; Total
Parenteral Nutrition
(TPN); lipids, and en-
teral fluids.
The Perfusor® Space
Infusion Syringe
Pump System is
intended to be used
by trained healthcare
professionals in
healthcare facilities,
home care, outpa-
tient, and medical
transport environ-
ments (this excludes
aircrafts).
*Technical Safety Check
951092 Rev C (03/08)

PERFUSOR SPACE® OVERVIEW
PERFUSOR® SPACE OVERVIEW
3
Up and Down Arrows
Scroll through menus, change setting of numbers
from 0-9, answer Yes/No questions.
Left and right Arrows
Select data from a scale and switch between digits
when numbers are entered. Access a function while
pump is running or stopped (with the left arrow key).
Press to reset single values
to zero and switch back to
the previous screen/ menu
level.
Press to Start/Stop
infusion.
Connects the pump to a PC
for calibration with the
service program
Access certain functions
and press to confirm
values/settings/alarms.
Syringe holder locks syringe
in position. To remove
syringe: Pull and move to the
right. The drive will
automatically move back.
q
c
kmSf
Port P2 for power supply, SpaceStation,
connection-lead (12V), combi-lead and
further accessory leads (staff call, service)
Port P3 for Space Station
Cover of Battery Compartment
Before changing the battery, always disconnect from the patient and switch off the device.
To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover
away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange.
Press to
initiate
bolus.
Press to
turn pump
on/off.
o
nB
rive head with
claws to hold the
syringe plunger
plate.
Emergency
release
button on
outside of
drive head.
Yellow LE : Pre-alarm, reminder alarm
Green / Red LE : Infusion occuring / device alarm,
operating alarm
Blue LE : For maintenance only - calibration.
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PERFUSOR® SPACE OVERVIEW
4
Syringe Fixation
Pull and turn the syringe holder to the right
to open the green axial fixation mechanism
(see red arrow). Syringe must be fixed with
wings upright in the slot to the left side of
the green axial fixation mechanism before
closing syringe holder. Make sure that
syringe is properly inserted.
4wCaution: on't touch piston brake
when moving forward.
Transport
A maximum of three pump, either
Infusomat Space or Perfusor® Space
may be stacked together.
Avoid additional weight or force.
Locking Devices Together
Line up the top lateral gap of the lower
pump with bottom rail of the pump above
and slide 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.
Fixation of PoleClamp (Universal Clamp)
Line up the rail of the PoleClamp with the
top lateral gap of the pump and slide
PoleClamp forward until locking
mechanism clicks.
To remove, press release button on frame,
push handle down and pull PoleClamp bak-
kwards.
Pole Fixation
Push opening of PoleClamp against 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
4wCaution: o not lean on pump when
attached to pole!
951092 Rev C (03/08)

PATIENT SAFETY
PATIENT SAFETY
Caution:
Federal law
restricts this
device to sale by
or on the order
of a physician.
Read Instructions
for Use prior to
start.
The infusion
device should
only be used by
specially trained
staff.
5
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 about the changes of the device and
accessories by referring to the Instructions for Use.
•Ensure the unit is properly positioned and secured. o not position the pump
over the patient's head to avoid injuries in case the pump falls down.
•Prior to administration, visibly inspect the pump and especially the axial
fixation for damage, missing parts or contamination and check audible and
visible alarms during selftest.
•Only connect to patient after correct syringe insertion and proper fixation of
the syringe plunger plate by the claws of the drive head. Interrupt
connection during syringe change to prevent inadvertent dose delivery.
•Select syringe/catheter suitable for use with the intended medical
application.
•Position the infusion line free of kinks.
•Recommended change of disposable every 24 hr (or as per national standard
guidelines or regulations or facility protocol).
•Installation in medically used rooms must comply with the appropriate
regulations (e.g. V E 0100, V E 0107 or IEC-publications). Observe national
specifications and deviations.
•Ensure stability of devices when mounting to an IV pole or rail.
•o 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 nurse call is used we recommend checking the equipment once after
connecting the pump.
•Protect the device and the power supply against moisture.
•o not carry the pump device by it's drive mechanism during transportation.
•If the pump is dropped 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.
•uring mobile use (homecare, patient transport inside and outside the
hospital): Make sure the device is securely secured and positioned.
Positioning changes and severe shock can lead to minor changes in the
delivery accuracy.
w
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PATIENT SAFETY
6
•A supplemental patient monitoring must be carried out if critical 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 are changing always the
dose rate will be updated and the rate will be fix.
Other components
•The drop sensor provides an additional safety function and is therefore
particularly recommended in connection with low delivery rates.
•Only use pressure resistant tubes (min. 2 bar/1500 mmHg).
•When 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 Pharmaceutical manufacturer’s information for possible medication
incompatibilities with equipment (material).
•Use only compatible combinations of equipment, accessories, working parts
and disposables with luer lock connectors.
•The use of incompatible disposables may influence the technical
specifications of the device.
•Connected electrical equipment must comply with the relevant IEC/EN-
specifications (e.g. IEC/EN 60950 for data-processing equipment).
The user/operator is responsible for the system configuration if additional
equipment is connected. The international standard IEC/EN 60601-1-1 has to
be taken into account.
Safety Standards
•Enteral nutrition:
The Infusomat Space may be used for enteral nutrition also. Make sure
enteral nutrition solutions are not administered intravenously as this may
harm your patients. For this therapy only infusion lines labelled for enteral
nutrition are permitted to be used in connection with special enteral
nutrition probes.
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
951092 Rev C (03/08)

7
PATIENT SAFETY
(e.g. HF surgical equipment, nuclear spin tomography units, mobile
telephones etc.) maintain the recommended protective distances from these
devices.
As there is no international standard for enteral nutrition pumps the safety fea-
tures of the Infusomat Space are also for this therapy designed according to IEC
601-2-24
Symbols
Electrical Shock Protection Rating
Protective Class
IP22 Protection against fluid ingress
4wCaution (refer to accompanying documents)
Canadian and U.S. Certification Mark: Products bearing this mark have
been tested and certified in accordance with applicable U.S. and
Canadian electrical safety and performance standards (CSA C22.2
No. 601.1, UL 2601-1 and IEC 60601-2-24).
951092 Rev C (03/08)

8
Status
Menu
Total
(T otal volume)
Total
(T otal amount)
Total
(T otal time)
Intermed.
volume
Intermed.
amount
Intermed.
time
Syringe
Drug Info
Batt. cap.
Version
Prime ?
Start Up
Menu
Main
Menu
Syringe
selection
Rate
Special
Functions
DoseRate
Calculation
VTBI
Time
UseLast
Therapy ?
Usedrug
library ?
Dose
Weight
Concentration
Drug Library
Status
Special
Functions
Options
Options
Menu
Occlusion
Pressure
Bolus
Rate
KVO-
Mode
Display
Light
Keypad
Light
Alarm
Volume
Data Lock
Contrast
Date
Time
Macro
Mode
Language
Usedose rate
calculation ?
Symbols
ENU STRUCTURE / OVERVIEW
MENU STRUCTURE / OVERVIEW
oOn/Off button
sfStart/Stop button
nbBolus button
CClear button
KOK button
QKeypad with arrow up, -down, -left, -right button
mConnection button
enu Structure
The pump can be customized by (de-)activating the menu itmes of the Start Up- and
Options Menu as well as the bolus function via the service program.
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9
MENU STRUCTURE / NAVIGATION
ENU STRUCTURE / NAVIGATION
At the top of the screen the last therapy is
indicated. Yes/No question can be
answered by pressing ufor yes or d
for no.
Parameters which can be changed (e.g.
rate in ml/hr) are accessed with lor
k. When editing parameters, switch
digits/levels using l r. White
background indicates current
digit/level. Use uor dto change
current setting. Help text on the
bottom/top of the screen indicates
options how to proceed (e.g. confirm
rate with k, start infusion with sf
or clear rate by pressing c).
Display Settings Explanation
A/C
connection
Battery
status
Unit of drug application
Active VTBI- or time preselection
Scrolling arrows indicate pump is infusing
Set rate can be accessed with l
Set pressure limit and
current pressure
Therapy profile
Typical display during infusion:
nbhas been pressed while the pump is
infusing. Start manual bolus at
1200 ml/hr 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 lwhen
that parameter is unable to be changed.
Total volume infused. Alternatively the intermediate volume can be displayed.
Remaining time
Remaining VTBI
951092 Rev C (03/08)

10
MENU STRUCTURE / NAVIGATION
Set pressure level with lor rand
confirm by pressing k.
Cancel to edit pressure by using c.
Optionally the pressure values can be
displayed in mmHg.
Pre-alarms are indicated by an alarm tone
with a message on the display (e.g.
“Syringe nearly empty”), and a flashing
yellow LE . Confirm a pre-alarm by
pressing k.
In case of an operating alarm (e.g.
"Syringe empty") the infusion stops, an
audible tone sounds and the red LE is
flashing. Confirm alarm by using k.
Press and hold ofor 3 sec to turn pump
off. A white bar stretches from left to
right and counts down the 3 sec.
Display Settings Explanation
All status information is available in the
bottom line of the dislplay. The desired
information can be selected by using u
dand will be displayed permanently
thereafter (e. g. drug long name, time until
syringe empty etc.).
951092 Rev C (03/08)

11
Chapter 1
OPERATION
OPERATION
1.1 Start of Infusion
•Ensure the pump is properly secured. Check if all pump components are present
and that there are no damages. If the pump is connected to A/C, the display
states information such as the battery status, the A/C connection symbol and last
therapy.
•Press oto switch on unit. Note the automatic selfcheck: “Selftest active” and the
software version are displayed; two audible tones sound and all three LE s (yellow,
green/red and blue) flash once. Information on power supply (battery or A/C
connection), the set pressure level and the syringe (if syringe already inserted) are
displayed. The drive mechanism will move backwards.
•Press cto enter therapy parameters or open pump cover and syringe holder to
start syringe loading.
•Insert syringe with its wings upright in the right side slot and into the left of the
green axial fixation mechanism before closing syringe holder. Close syringe holder
and pump door. Piston brake moves forward.
4wCaution: Never leave the pump unattended during syringe loading.
•Confirm syringe type with k. Type/brand of syringe selected on display must
coincide with syringe inserted.
•rive mechanism will advance and grip pressure plate of syringe piston.
4wCaution: 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 Uto prime infusion line/set at 1200 ml/hr
(pressing key once = 1 ml). Interrupt prime function with k. Repeat procedure
until infusion line/set is fully primed. Then press dto proceed.
•Connect with patient.
•Answer the questions in Start Up Menu with uand d, until the rate is displayed
in the Main Menu.
Enter infusion rate:
•Press land set rate using q.
The pump offers the possibility to load up to four languages into the pump
(depending on the number of the language specific characters), among which the
user can choose during the operation of the pump. uring 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
tand confirmed with k. Answer the following question with din order to
activate the selected language.
951092 Rev C (03/08)

12
OPERATION
Chapter 1
•Press sfto start infusion. Running arrows on display and green LE above
display indicate that infusion was started.
Note: Stop the infusion at any time by pressing sf. The pump can be turned off
at any time by pressing ofor 3 sec (Exception: ata lock level 2).
1.2 Setting Different Combinations of Rate, VTBI
(= Volume To Be Infused) and Time
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 are preselected, an arrow symbol is placed in front of
that parameter in the Main Menu. It is called the “target”. uring infusion this target
symbol is displayed next to the moving arrows in the run display. This indicates that
the pump has been programmed, either with a volume or time limit. The target symbol
indicates the established parameter in the Main Menu (VTBI or time). When the rate is
changed, the so-called target parameter is maintained and only the third parameter is
recalculated. After infusion has started, the remaining VTBI and time are displayed in
the Main Menu and the values on run display will be counting down.
1.) Enter VTBI and time: The infusion rate will be calculated and shown on the bottom
of the display.
Target: Volume
•Select VTBI with tand access with l.
•Enter VTBI with qand confirm with k.
•Select time with tand access with l.
•Enter time with qand confirm with k.
Check if calculated rate value is correct.
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 indicated on the
bottom of the display.
Target: VTBI
3.) Infusion with time limit
Enter rate and time: The infusion volume will be calculated and indicated on the
bottom of the display.
Target: Time
Changing 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. Previous and new target: VTBI
951092 Rev C (03/08)

13
•Change of time => Adjustment of rate. Previous and new target: VTBI
b) Target symbol is placed in front of time:
•Change of time => Adjustment of VTBI. Previous and new: Time
•Change of VTBI => Adjustment of time. New target: VTBI
1.3 Bolus Application
There are three ways to administer a bolus:
1.)Manual Bolus: Press nb. Then press and hold kbutton. Fluid is
administered as long as button is held down. The infused bolus volume is
displayed. Maximum bolus volume is limited to 10 % of the syringe size or
10 sec.
2.)Bolus with volume preselection: Press nb. Then press land set bolus dose
limit by using q. Press nbto confirm and start bolus.
epending on the service tool settings an acoustic signal will sound after
finishing the bolus volume.
3.)Bolus with rate calculation: Press nb. Then press land set bolus dose
by using q. Press kto confirm bolus dose. Set time in which a bolus is to
be delivered, with q. Calculated bolus rate is shown on top of the display.
Press nbto confirm and start bolus.
The unit of the bolus always depends on the selected dose. For example if the
dose selected is mg/kg/hr, then the bolus will be given in mg/kg. If a dose is
administered without a relation to the patient's weight (mg/hr), then the bolus
will be given in mg.
After pressing the button nbthe bolus unit can be selected to ml by using d.
The selected unit will then be stored as the default selection.This enables
the user to administer a bolus in milliliters. Available in dose calculation mode.
You can use the service program to enter a default and a maximum bolus rate.
Once a new therapy is started, the device always returns to the default rate,
even if the bolus rate was manually changed beforehand.
Note: If the bolus limit is not entered after pressing nb, the pump switches
back into the run display automatically.
Note: The infused volume during bolus with volume preselection counts up.
In order to purge the line at any time while the pump is stopped press nb.
Answer the following question by pressing uin order to start the purge
process. Cancel by pressing kor any other key.
4wCaution: Take care not to overdose! Given a bolus rate of 1200 ml/hr, 1 ml
will be administered in just 3 sec. To cancel bolus infusion at any time press k.
Chapter 1
OPERATION
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14
OPERATION
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. isconnect
patient while purging.
1.4 Syringe Change and New Therapy Start
Note: Always disconnect patient line before syringe change to avoid inadvertent
administrations. Never leave the pump unattended during syringe change. Before
inserting a new syringe check if the green axial fixation is properly working.
•Press sfto stop the infusion. The green LE will go off. isconnect from the
patient.
•Open syringe holder. rive 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
ubefore 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 uto
initiate the release of the syringe plunger.
•Open pump door, remove syringe and insert new syringe.
Note: When performing a syringe change and in case the piston plunger of the syringe
is not released by the claws of the drive head mechanism, the emergency release
button needs to be pressed to have the claws released. The emergency release button
is placed on the outside of the drive head. It can be pressed with a pointed pen. Then
manually open the claws and take out the syringe.
•Close syringe holder (Note: Piston brake must move forward!) and pump door.
Confirm inserted syringe type/brand with k. rive mechanism advances and claws
will grip pressure plate of syringe plunger.
Note: o not block advancing drive unit with any objects. Piston brake must move
backwards into the syringe holder.
•If necessary prime line with uthen press dto continue.
•Connect patient line and check set parameters using t.
•Press sfto start infusion.
To start a new therapy after a syringe change:
•Press cwhen pump is in Main Menu.
•Press dand continue to set new therapy parameters with q.
•Press sfto start infusion.
Note: A new therapy can be started at any time during a stopped infusion. Press
c(repeatedly) when the pump is in Main, Status or Options Menu and proceed
to follow instructions as described.
Chapter 1
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15
Chapter 1
OPERATION
1.5 End of Infusion
•Press sfto stop infusion. The green LE will go off. isconnect from the
patient.
•Open the syringe holder. The drive mechanism will move backwards into the
starting position.
•Open pump door. Remove syringe, turn the syringe holder into an upright position
and close the front door.
•Press ofor 3 sec. to switch the pump off. The drive will move into parking
position.
As long as a disposable is inserted in the pump the pump will use standby.
Note: The settings will be saved in the switched off device.
1.6 Standby ode
In case of extended interruption, the user has the option to maintain the set values.
•Press sfto stop the infusion. Then press ofor less than 3 sec.
•Confirm that the pump is supposed to switch into standby by pressing u.
•The default time for standby is displayed. Accept the default time with kor
change it with q(0-24 hours) and then confirm it by pressing k.
=> While the pump is in the standby mode, it’s display shows the remaining time for
standby. Exit standby by pressing k.
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16
Chapter 2
A VANCE OPERATIONS
ADVANCED OPERATIONS
2.1 Request Status of Infusion while Pump is Running
Press cto switch between run display and Main Menu while the pump is running.
Navigate through the menu using tto check parameters. In order to check parameters
in the Status/Options Menu, select "Status" or "Options" in the Main Menu, access
selection with land scroll through menu with t.
Status information is also available as a default on the display (e.g. drug long
name, time until syringe empty, etc.). To select, as the pump runs press either
cursor button up or down. Scroll and choose desired information. Desired
information will remain as the default display setting.
2.2 Rate, VTBI and Time Change Without Infusion
Interruption and Reset of Status enu Data
•Press cwhile pump is running in order to switch to the Main Menu. Select rate/
VTBI/time with tand press lin order to access the parameter.
•Enter new value with qand confirm with k.
Reset Data in Status enu:
Parameters like intermediate volume and time can be reset while pump is running or
when the pump is stopped.
•Select “Status” in Main Menu with tand press l.
•Highlight intermediate volume (in ml) or intermediate time (in hr:min) with tand
access parameter with l.
•Reset values by pressing u.
Both parameter total volume and total time, are displayed in the pump as "Total" with
the according unit and can only 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 uand 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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17
SPECIAL FUNCTIONS
SPECIAL FUNCTIONS
3.1 Dose Rate Calculation (Overview)
The dose rate calculation enables a calculation of the rate in ml/hr from the entered
dose parameters.
Setting parameters:
1. Concentration is the amount of drug (active ingredient) per volume:
Amount of drug (active ingredient) in µg, mg, mmol, IU or mEq per
Volume in ml.
2. Where necessary: Patient weight in g, kg or lbs.
3. ose prescription:
- time related to the amount of drug (active ingredient) per min, hr or
24hr.
- time and patient weight related to the amount of drug (active
ingredient) per kg per min, hr or 24hr.
3.2 Dose Rate Calculation (Operation)
aSelect dose rate calculation with l.
aSelect the unit of the active ingredient with Tand confirm it with l.
aEnter the concentration by entering the amount of drug (active
ingredient) and the volume. In order to do so set the values with qand
confirm with k.
aIf the patient weight shall not be entered press d.
Press ufor a time and weight related calculation, set the patient
weight with qand confirm it with k.
aSelect the dose unit with tand confirm it with l.
aSet the dose value with qand confirm with k. The rate will be
automatically calculated and shown on the bottom of the display.
aCheck with tif the calculated rate and if necessary the adapted
parameters on the screen are correct before starting infusion with sf.
Concentration and dose can later be changed in the Main Menu in the same
way as the rate, VTBI and time (compare 2.2). Changes made to weight and
doses interfere with other parameters. The effects of those changes are shown
on the bottom of the display.
Additionally the total and intermediate amount of the infused drug can be
removed from the Status Menu. These can be checked and reset in the same
way as the other total and intermediate values.
Chapter 3
Infusion rate [ml/hr] =x Patient weight (optional)
ose
Concentration
[]
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18
Chapter 3
SPECIAL FUNCTIONS
To get out of dose rate calculation is only possible when the pump is stopped.
Press cfrom Main Menu and then press d.
4wCaution: A change of the patient weight will alter the flow rate.
3.3 Drug Library
Up to 720 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 ("rug List Editor Space“).
Note: The drug library can be access on Start Up and Special Functions Menu.
The user has to make sure prior to start therapy that the drug library in the
pump complies with the patient target group or area of application. The name
of the drug library (see headline) will be displayed on the pump.
There are different ways of activating the drug library. This can be done while
the infusion is running or when the pump is stopped.
A drug name including the according therapy data can be taken from the drug
library. If a rate, VTBI and/or time were already defined in the Main Menu, the
drug name and the adjusted values of the set data will be loaded. If a dose rate
calculation was already started a belated assignment of the drug name is not
possible anymore.
How to activate a drug name and related parameters:
•Open the drug library by pressing l.
•Navigate through list with tand select the category with l.
•Select the drug from the category with l.
•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 parameters in Main Menu with tand start infusion
with sf.
Hard Limits:
If the set rate/dose/bolus volume and bolus rate exceed the values stored in the
drug library (hard limits), the drug will be rejected, " oseGuard - Values have
reached upper limit" 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 the
infusion.
Soft Limits:
For the same parameters so called soft limits can be preset via the rug List
Editor. These can be exceeded without any constraint. The following symbols
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Chapter 3
OPTIONS
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 limit =
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.
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Chapter 4
OPTIONS
OPTIONS
The options functions may be selected and changed while the pump is running or
stopped. To edit a menu item, select “Options” in the Main Menu and press l.
Then select desired function with tand follow the Instructions for Use as described.
4.1 Downstream Occlusion Pressure
The higher the pressure level between the pump and the patient is set at, the higher
the pressure level must rise before triggering an occlusion pressure alarm.
•Access pressure in Options Menu by pressing l.
•Choose between nine pressure levels (1=lowest level; 9=highest level) by
pressing lor rand confirm entry with k.
4.2 Data Lock
The data lock function protects the device against unauthorized access. A four
digit code (default setting “9119”), which can be modified via the service
program activates this function. There are two security levels.
Level 1:
Modification of values as well as a bolus application is not possible but a
change of the disposable can be conducted. It is possible to navigate through all
menus and status data can be checked. Starting, interrupting and switching the
pump off is possible.
Level 2:
This level has the same performance characteristic as described under level 1
and additional will not allow the change of disposable. In order to prevent a
data-lock alarm the correct code must be entered within 20 sec after the pump
stopped. Changing the disposable and switching the pump off is only possible
after the code has been entered.
Activation of the function:
•Access data lock in Options Menu with l.
•Select between level 1/2 with land rand confirm with k.
•Enter code with qand press kin order to activate data lock.
Changes of protected values as well as the bolus function that are marked with
yare only possible after entering the code. After 20 sec in the Main Menu,
Status Menu, Special Functions Menu and Options Menu the lock will be acti-
vated again. If the wrong code is entered twice the pump will switch into the
last menu. If the wrong code is entered twice again the pump will go into an
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