infusomat_space_instructions_for_use_sw_686d.pdf
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Infusomat® Space
and Accessory
Instructions for Use
Valid for Software 686D
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CONTENTS
CONTENTS
Contents
........................................................................................................................2
Infusomat® Space Overview...................................................................................................3
Patient Safety
........................................................................................................................5
Menu Structure / Overview ....................................................................................................7
Menu Structure / Navigation.................................................................................................8
Chapter 1
Operation..........................................................................................................10
1.1 Start of Infusion .........................................................................................................................10
1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused)
and Time .......................................................................................................................................12
1.3 Bolus Application.......................................................................................................................13
1.4 Infusion Line Change and New Therapy Start ..................................................................13
1.5 End of Infusion ...........................................................................................................................14
1.6 Standby Mode.............................................................................................................................14
The Infusomat®
Space is according to IEC/EN
60601-1 resp.
IEC/EN 60601-224 a volumetric
infusion pump
for infusion of
small and large
volumes at
highest accuracy
and is suitable
for intravenous
applications, for
blood transfusion
and for enteral
nutrition.
The medical
specialist has to
decide on the
suitability of the
application. The
decision has to
be made on the
basis of the
warranted
properties and
technical data.
For further
details please
refer to the
Instructions for
Use.
Chapter 2
Advanced Operations....................................................................................15
2.1 Status Request of Pump when Infusion is Running........................................................15
2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset
of Status Menu Data ................................................................................................................15
Chapter 3
Special Functions...........................................................................................16
3.1 Dose Rate Calculation (Overview) ........................................................................................16
3.2 Dose Rate Calculation (Operation) .......................................................................................16
3.3 Drug Library.................................................................................................................................17
Chapter 4
Options..............................................................................................................18
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
Chapter 5
Occlusion Pressure.....................................................................................................................18
Data Lock......................................................................................................................................18
Bolus Rate....................................................................................................................................19
KVO-Mode....................................................................................................................................19
Contrast / Display Light / Keypad Light ..............................................................................19
Alarm Volume..............................................................................................................................19
Date / Time ..................................................................................................................................19
Macro Mode ................................................................................................................................20
Language ......................................................................................................................................20
Alarm .................................................................................................................21
5.1 Pre-Alarms and Operating Alarms ........................................................................................21
5.2 Reminder Alarms........................................................................................................................24
5.3 Alarm Hints..................................................................................................................................24
Chapter 6
Battery Operation and Maintenance .......................................................25
Chapter 7
Start Up Graphs and Trumpet Curves......................................................27
Chapter 8
Technical Data ................................................................................................28
Chapter 9
Warranty / TSC* / Service / Cleaning / Disposal ..................................30
Chapter 10 Instructions for Use Accessory ..................................................................32
Ordering
.....................................................................................................................36
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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.
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
Open certain functions
and press to confirm
values/settings/alarms.
m
Press to link the pump to
SpaceControl and to assign a
barcode after scanning.
Press to
open the
pump door.
x
Press to turn
pump on/off.
B o
n
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 SpaceControl
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
Pressure
sensor
Opening lever
Safety
clamp
Air
sensor
Signal lamp
Line guide
cover
Upstreamsensor
Fixaton of PoleClamp (Universal Clamp)
Line up bar of pump with bar of PoleClamp
and slide PoleClamp forward until locking
mechanism clicks.
To remove, 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.
Avoid external mechanical influence.
Locking Devices Together
Line up the bar of lower pump with bar of
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.
Pole Fixation
Push opening of PoleClamp against vertical
pole and lock screw tight. 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
Operation
should only be
used by specially
trained staff.
• Ensure the unit is properly positioned and secured. The pump must be
positioned on a level surface if used in combination with the short stand. Do
not position the pump above the patient.
• 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
Read Instructions
user is requested to inform himself about the changes of the device and
for Use prior to use.
accessories in the Instructions for Use.
The infusion device
• Prior to administration, visibly inspect the pump for damage, missing parts or
contamination and check audible and visible alarms during selftest.
• Connect to patient only after the line was correctly inserted and completely
primed. Interrupt connection during line change to prevent incorrect dose
delivery.
• Select infusion line/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.
• 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.
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PATIENT SAFETY
• 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.
Other components
• Use only pressure-proof and compatible disposable items (min. 2 bar/
1500 mm Hg) to avoid that performance data are influenced – 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/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.
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MENU STRUCTURE / OVERVIEW
MENU STRUCTURE / OVERVIEW
Cutline
o
On/Off button
x
Door open button
f
s
Start/Stop button
b
n
Bolus button
C
Clear button
K
OK button
Q
Keypad with arrow up, -down, -left, -right button
m
Connection button
Menu Structure
Start Up
Menu
Main
Menu
Special
Functions
Status
Menu
Options
Menu
Line
selection
Concentration
Dose Rate
Calculation
Total
(Total volume)
Pressure
Prime ?
Weight
Drug Library
Total
(Total amount)
Data Lock
Use last
therapy ?
Dose
Total
(Total time)
Bolus
Rate
Use dose rate
calculation ?
Rate
Intermed.
volume
KVOMode
Use drug
library ?
VTBI
Intermed.
amount
Contrast
VTBI
Time
Intermed.
time
Display
Light
Status
Line
Keypad
Light
Special
Functions
Batt. cap.
Alarm
Volume
Options
Version
Date
Time
Macro
Mode
Language
The pump can be customized by (de-)activating the menu itmes of the Start Up
(except VTBI) and Options Menu as well as the bolus function via the service program. 7
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MENU STRUCTURE / NAVIGATION
MENU STRUCTURE / NAVIGATION
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
Set pressure limit and
current pressure
Battery
status
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
Remaining time
Remaining VTBI
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.
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MENU STRUCTURE / NAVIGATION
Display
Meaning
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 a flashing yellow LED.
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.
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.
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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.
• Fill the infusion line from below to the top, then close the roller clamp.
• 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.
During the first ever start-up of the device, the user is requested to select the
language with t and confirm with l. Answer the following question with d in
order to take over 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.
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.
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.
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OPERATION
Chapter 1
In the next step, attach the white
clip without twisting the line.
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).
• Close the pump door. Then select the inserted line with t and confirm it with l.
Open the roller clamp.
Caution: If a wrong line is selected, errors may occur during VTBI delivery and the
alarm limits are shifted.
• 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. If you select d with no drop sensor connected,
you must first enter a VTBI which is smaller than the container filling and confirm
it with k.
Note: Due to safety reasons, it is recommended to use the drop sensor - particularly in
connection with delivery rates ≤ 10 ml/h.
Adjusting the delivey rate:
• In the Main Menu, open the rate with l and set it with q.
• Press s
f to start the infusion. Running arrows on the display and the green
LED indicate that the pump is infusing.
Note: The running infusion can be cancelled at any time by pressing s
f. The
pump can be switched off at any time by pressing o for 3 sec (Exception: Data
lock level 2).
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OPERATION
Chapter 1
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 will
be 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 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 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
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OPERATION
Chapter 1
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 sec.
2.) Bolus with volume preselection: Press n
b. Then press l and set bolus limit
by using q. Press n
b to confirm and start bolus.
3.) Bolus with rate calculation: Press n
b. Then press l and set bolus limit
by using q. Press k to confirm bolus limit. 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.
The unit of the bolus always depends on the selected dose. If the dose is for
example selected as mg/kg/h, then the bolus will be given in mg/kg. If a dose is
administered without a relation to the patient's weight (mg/h), then the bolus
will be given in mg.
You can use the service program to enter a default and a maximum bolus rate.
After a new therapy start, however, 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.
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.
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 s
f 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: If for an unknown reason the pump door cannot be opened anymore, you need
to take a crank from the inside of the battery compartment cover. Use this crank to
remove the emergency aperture cover of the pump. Place the crank in the aperture and
turn it clockwise until the pump door opens.
• 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.
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OPERATION
Chapter 1
• Establish the patient connection and check the parameters with t.
• Start the infusion by pressing s
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 s
f 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.
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 the pump is supposed to switch into standby by pressing u.
• The default time for standby is displayed. Accept the default time with k or
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
this mode. Exit standby by pressing k.
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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 resetted 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 being 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 line is displayed in menu item „Line“ and cannot be changed
once it has been confirmed at the beginning of the infusion. 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.
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.
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.
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.
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 be
automatically calculated and displayed on the bottom of the display.
a Enter VTBI if necessary with q and confirm it with k. The time will be
automatically calculated and displayed on the bottom of the display.
a Check the parameters with t on plausibility before starting with s
f.
Concentration and 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 weight and
dose modifications on other parameter are being shown on 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.
16
A deactivation of the dose rate calculation is only possible when the pump is
stopped. Press c from Main Menu and then press d.
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SPECIAL FUNCTIONS
Chapter 3
3.3 Drug Library
300 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 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 was already started a
belated assignment of the drug name is not possible anymore.
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.
If the rate/dose/bolus volume and bolus rate exceed the values of the stored
values in the drug library (hard limits), the drug will be rejected, a hint will be
displayed and the pump will fall back into the Main Menu. If this occurs while
the pump is infusing the pump will continue to administrate.
Note: An adequate monitoring of highly potent drug administration is required
by law.
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OPTIONS
Chapter 4
OPTIONS
The options functions may be selected and changed while the pump is infusing or
stopped. To edit a menu item, select “Options” in the Main Menu and press l.
Then select desired function with t and follow the Instructions for Use as described.
4.1 Occlusion Pressure
The higher the pressure level is set at, the higher the pressure level must rise before
triggering an occlusion pressure alarm.
• Enter pressure in Options Menu by pressing l.
• Choose between nine pressure levels (1=lowest level; 9=highest level) by pressing
l or r and 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 changed via the service
program activates this function. There are two security levels.
Level 1:
A modification of values as well as a bolus application are 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. In
order to prevent a data-lock alarm the correct code must be entered within 20
sec after the pump was stopped. Changing the disposable and switching the
pump off are only possible after the code was entered.
Activation of the function:
•
Open data lock in Options Menu with l.
•
Select between level 1/2 with l and r and confirm with k.
•
Enter code with q and press k in order to activate data lock.
Changes of the protected values as well as the bolus function that are marked
with y are 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
activated 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 audible alarm, a nurse call will go off and the yellow LED blinks. If a target
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OPTIONS
Chapter 4
value was reached while data lock is active a new start of the pump is only possible after entering the code.
In order to deactivate the function, select “Off” in the data lock, press k, enter
the code and press k again.
4.3 Bolus Rate
• Open bolus rate in Options Menu with l.
• Change bolus rate with q and confirm setting with k.
Note: Set bolus rate according to therapy requirements. Take care not to overdose!
Given a bolus rate of 1200 ml/h, e.g. 0.33 ml are reached within just one second.
4.4 KVO-Mode
The pump can continue the infusion with a preset KVO-rate after a preselected
VTBI/time has passed (see "Technical Data"). The duration of the KVO delivery is defined
in the service program.
• Open the KVO-mode in the Options Menu with l.
• Answer the Yes/No question with u to enable the KVO-mode.
4.5 Contrast / Display Light / Keypad Light
Contrast as well as display- and keypad light can be adjusted individually according to
the lighting conditions.
• Open contrast/display light/keypad light in Options Menu by pressing l.
• Choose between 9 contrast- and display light levels with l or r and confirm
with k.
4.6 Alarm Volume
Chose between 9 different alarm volume levels.
• Open alarm volume in Options Menu with l.
• Set volume with l or r and confirm entry with k.
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OPTIONS
Chapter 4
4.7 Date / Time
• Open date/time in the Options Menu with l.
• Modify date and time with q and confirm the setting with k.
4.8 Macro Mode
The infusion rate appears larger on the display when the macro mode is activated and
the pump is infusing.
• Open macro mode in Options Menu with l.
• Answer Yes/No question by pressing u to activate the macro mode.
For quick activation of macro mode: Press and hold r while the pump is infusing
until the font size changes.
4.9 Language
This function enables a change of the pump language.
20
•
Open language in the Options Menu with l.
•
Select language with t then press l.
•
Confirm Yes/No question with u.
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ALARM
Chapter 5
ALARM
The Infusomat® Space is equipped with a audible and optical alarm signal.
Alarmtype
Device
Alarm
Audible
signal Red LED
yes
flashes
OperatingAlarm
yes
flashes
PreAlarm
yes
off
flashes
see alarm
description
Reminder yes
Alarm
off
flashes
see alarm
description
Alarm
Hint
off
off
see alarm
description
yes
Optical signal
Yellow LED Text
off
device alarm
and alarm
code
(see service
program)
off
see alarm
description
Staff call
User confirmation
yes
Press and hold O
until the pump
switches off after a
few seconds.
Press k to
acknowledge the
audible alarm, alarm
text and staff call. The
red LED remains on
until the infusion is
restarted.
(de-)activate Press k to mute
alarm and turn off staff
via service
call. Visible alarm
program
remains until end.
Press k to mute
yes
alarm, turn off staff
call and delete the
alarm text.
Hint disappears
no
without confirmation.
yes
5.1 Pre-Alarms and Operating Alarms
Pre-alarms:
Pre-alarms occur a few minutes (dependable on service settings) prior to operating
alarms. During pre-alarms an audible tone sounds, the yellow LED blinks and a staff
call is activated (optional). The display message varies depending on the alarm reason.
The signal tone and the staff call are turned off with k. Display and LED stay in prealarm until the operating alarm goes off. Pre-alarms don't lead to an interruption of
the infusion.
Display message
Pre-alarm reason
“VTBI near end“
The preselected volume is nearly infused.
“Time near end“
The preselected time is almost over.
“Battery nearly empty“
The battery is almost discharged.
“KVO active“
VTBI/time are reached and the pump continues
the infusion at the KVO-rate.
"Communication error"
The pump is located in a system in which at least
one device is incompatible or defective. The use
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ALARM
Chapter 5
of this device in a system is not permitted. The
system is to be checked by a service technician.
A stopwatch on the display counts down the remaining time (depending on the
service program, between 3-30 min). After that, the pump changes to the
operating alarm.
The pre-alarms “VTBI near end“ (volume preselection) and “Time near end“ (time
preselection) can be deactivated via the service program.
Operating alarms:
Operating alarms lead to an interruption of the infusion. An audible tone
sounds, the red LED flashes and a staff call is activated. The display states
“Alarm“ and the reason for the operating alarm. The signal tone and the staff
call are turned off with K. Corrections are to be made according to the alarm
reason.
22
Display message
Alarm reason
“VTBI infused “
The preselected volume was infused.
Continue therapy or select new therapy.
“Time expired“
The preselected time has ended.
Continue therapy or select new therapy.
“Battery empty“
The battery pack is discharged.
Connect device with mains and/or exchange
battery pack. The battery alarm will be on for 3 min.
Then the pump will automatically turn off.
“Pressure high“
An occlusion occured in the system. The set pressure
level was exceeded. A bolus reduction is automatically
initiated by the pump.
Check if tubing contains kinks or is damaged as well
as IV- and filter patency.
Increase occlusion pressure if necessary.
“KVO finished“
The KVO-time has ended. Continue therapy or set new
therapy.
“Battery cover removed“
The battery cover is not properly engaged on the
battery compartment.
When pushing on the battery cover listen for “click”.
“Standby time expired“
The set standby time has ended.
Set new time or continue with previously set therapy.
“No battery inserted“
It is not possible do use the pump without a
battery pack.
Turn off pump and insert battery pack according
to describtion “Overview Infusomat® Space“.
“Drive blocked“
Stepper motor does not deliver due to excess pressure
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ALARM
Chapter 5
in the system.
Interrupt patient connection and reinsert the line.
“Calibrate device“
Pump calibration data have changed (e.g. after an
update).
Recalibrate device via the service program.
“Drop sensor connection“
Contact to the drop sensor is interrupted while the
pump is delivering.
Check whether the drop sensor is correctly placed on
the drop chamber. If necessary, replace the drop
sensor or preselect VTBI/time and proceed with
therapy.
“Check upstream“
The upstream sensor triggers an alarm.
Check if roller clamp is closed or infusion line is
kinked. If a drop sensor is connected the upstream
alarm is deactivated.
“Air bubble "/"Accumulated air“ Air inside the system.
Check the line for small air bubbles and disconnect
from patient to repeat priming, if necessary.
“No drops“
The drop sensor does not detect any drops.
The infusion container is empty, the roller clamp is
closed, the drop sensor is not put on, check the line
for obstructions, condensation on drop chamber
(remove by shaking it).
"Too few drops"
The number of fallen drops is lower than the preset
rate.
A negative pressure in a glas infusion container can
be eliminated by opening the vent flap on the drop
chamber. Check whether the infusion bottle is empty,
the roller clamp is completely opened and whether
there are any kinks in the line.
"Too many drops"
The number of fallen drops is higher than the preset
rate.
Check the line for damage and make sure that the
line is correctly inserted.
"Flow"
Drop chamber is completely filled or leak in the
system.
Examine the line for damage and check the drop
chamber.
“Data were reset”
Therapy and pump settings could not be restored.
Enter therapy and pump settings ane
new.
"Therapy data were reset"
Therapy data could not be restored.
Enter therapy anew.
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ALARM
Chapter 5
“Data Lock"
It was tried to stop or switch the pump off without
entering the code.
Enter the correct code in order to continue the
therapy respectively turning the pump off.
The red LED doesn’t extinguish until the administration is started again respectively the
pump is turned off.
Caution: If a wrench is displayed and/or a yellow, red and blue LED blink then the
pump is in the service mode and is not permitted to be used on a patient. The pump is
then to be checked by a service technician.
5.2 Reminder Alarms
Reminder alarms only occur in two cases:
1. A line is inserted, the pump does not deliver, no value is edited and the device is not
operated for two minutes.
An acoustic tone sounds, the yellow LED blinks and a staff call is activated.
a) The display states “Reminder alarm!”
b) The display states “Config. not finished!”
Confirm alarm with K and continue to set therapy/Start Up configuration.
2. A value edition was started but not finished and confirmed. This is also possible
with a missing disposable.
An acoustic tone sounds, the display states “Value not accepted“, the yellow LED
blinks and a staff call is activated.
Confirm alarm with K and continue to set therapy.
5.3 Alarm Hints
If inproper entries are made the display states corresponding hints (e.g. “Attention!
Rate is out of range”; “The parameter can not be modified”) and an audible tone
sounds. These hints disappear after a few seconds and don't need to be confirmed.
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BATTERY OPERATION AND MAINTENANCE
Chapter 6
BATTERY OPERATION AND MAINTENANCE
The Infusomat® Space is equipped with the latest NiMH-battery. It has an operating
lifetime of 4 hours at 100 ml/h when new. For optimal treatment of the battery, the
device is equipped with protection against overcharge and deep depletion. The battery
pack is charged by the pump during connection to mains. When disconnected from
mains or in case of power failure, the pump automatically switches to battery power.
Note: Prior to a longer storage of the pump (> 0,5 months) the battery pack must be
completely charged and then removed from the pump. Before changing the battery,
always disconnect the pump from the patient and switch off the device.
The battery status indicator is a trend display (low, medium, high). For more detailed
information on the current battery capacity (operating time in hours and minutes)
please refer to menu item “Batt. Cap.” in the Status Menu of the Infusomat® Space.
Important information for battery self-check:
If the battery symbol is blinking during mains operation, the battery is either
discharged or has a reduced capacity. In this case, the pump should not be
disconnected from mains. If it is necessary to disconnect the pump from mains power
for urgent reasons, the user should check to ensure if the battery capacity is sufficient
for the proposed use. When the battery symbol blinks permanently (>1h), the battery
must be checked by a technician and replaced if necessary.
Directions for optimal battery use:
The actual battery life may vary due to
• ambient temperature
• varying load (e.g. frequent boluses).
The optimal life time of a battery pack will only be reached if it's completely discharged from time to time. A maintenance mode which conducts this battery maintenance
is built in. This function should be activated once a month. Furthermore:
• If possible, only charge the battery if it has been completely discharged.
• If a battery, which is not completely discharged, is charged several times, its
capacity can be reduced. Its original capacity can be reached again if the battery
is completely discharged and then recharged.
• Under normal temperature conditions a battery can be charged and discharged
approx. 500 times before its lifetime decreases.
• When the pump is not connected to mains power the battery discharges itself
slowly. This can occur even when the pump is not operating. The original
capacity will only be reached after several cycles of charging and discharging.
• The battery operating time only can be realized if the pump operates
continuously with a fully charged battery at room temperature. The display of
the battery operating time on the pump is an approximate value based on the
current delivery rate. If the battery is aged it may differ from the actual
achievable operating time.
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