B. Braun Infusomat compact plus P User manual

c e 0123
LLDorder 4900 - lw04-2020 (Basis DE v3)
Infusomat®compactplus P
Instructions for use
EN – Version 1.0
Valid for software 003A
Hinweis AK-Protokollierung
Markierung grün
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»changeReport #4«
vom25.05.2020
Markierung braun
markiert den
»changeReport #5+6«
vom05.06.2020 
Markierung »grau«
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»changeReport #7«
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Table of Contents
1About this document...........................................5
1.1 Purpose........................................................................5
1.2 Signs, symbols and tags......................................5
1.3 Warnings....................................................................6
1.4 Abbreviations...........................................................6
2Symbols.......................................................................7
2.1 Symbols on the product and packaging.....7
2.2 Symbols on the device’s display.....................8
3Intended use.............................................................9
4Safety instructions.............................................10
4.1 Safe handling........................................................10
4.1.1 General.......................................................................10
4.1.2 Software ....................................................................10
4.1.3 Transport and storage............................................10
4.1.4 Set-up and start-up ...............................................10
4.1.5 Stacking.....................................................................11
4.1.6 Operation...................................................................11
4.1.7 Alarms and staff call..............................................12
4.1.8 Accessories and consumables..............................12
4.1.9 Enteral nutrition......................................................13
4.2 Electrical connection.........................................13
4.3 Safety standards..................................................13
5Description of the device................................14
5.1 Device overview...................................................14
5.2 Interfaces................................................................15
5.3 Display and control elements.......................16
5.4 Display overview..................................................18
5.5 Alarm status display..........................................18
6Menu structure/devicefunctions................19
6.1 Main menu.............................................................19
6.1.1 Main menu > Rate,volume&time ...................19
6.1.2 Main menu > Drug .................................................19
6.1.3 Main menu > Dose calculation...........................20
6.1.4 Main menu > Settings...........................................20
6.1.5 Settings > Service...................................................21
7Set-up and start-up...........................................22
7.1 Setting up and connecting the device.....22
7.1.1 Attach/remove the compactplus pole clamp....22
7.1.2 Operating the device on a stand.........................22
7.1.3 Operating the device in the
compactplus station.................................................22
7.1.4 Operating the device on a wall rail....................22
7.1.5 Connecting the device to the
mains electricity......................................................22
7.1.6 Operating the device on batterypower............22
7.2 Powering on the device
forthe first time..................................................22
7.3 Configure device options................................22
7.3.1 Turning night mode on/off...................................23
7.3.2 Setting display brightness ....................................23
7.3.3 Setting the audio volume .....................................23
7.3.4 Configuring the pressure alarmlimit................23
7.3.5 Configuring service settings ................................24
7.4 Locking/unlocking thekeypad......................25
8Operation ................................................................26
8.1 Switching on the device..................................26
8.2 Inserting the infusion line..............................26
8.3 Priming the infusion line.................................27
8.4 Use with Intrafix®SafeSet.............................28
8.5 Setting the infusion values............................28
8.5.1 Entering the delivery rate.....................................28
8.6 Starting and stopping theinfusion............29
8.7 Activating standby.............................................29
8.8 Administering a bolus.......................................30
8.8.1 Administering a manual bolus ............................30
8.8.2 Administering a bolus with preselected
bolusvolume/bolus duration...............................30
8.9 Using the drug database.................................31
8.9.1 Hard and soft limits................................................31
8.10 Calculating the dose..........................................32
8.11 Entering a combination ofdelivery rate ,
volume and time..................................................33
8.12 Resetting the therapy.......................................34
8.13 Changing the infusion line.............................34
8.14 Ending the infusion............................................34
8.15 Switching off the device.................................34
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9Alarms.......................................................................35
9.1 Device alarms........................................................35
9.2 Pre-alarms and operatingalarms...............35
9.2.1 Pre-alarms.................................................................35
9.2.2 Operating alarms.....................................................36
9.3 Reminder alarm....................................................37
9.4 Display Notifications.........................................37
10 Cleaning and care...............................................38
10.1 Cleaning & Disinfection...................................38
10.2 Battery operation andmaintenance.........39
10.2.1 Notes for optimal batteryoperation .................39
10.2.2 Changing the battery ............................................40
11 Decommissioning................................................40
12 Maintenance and repair..................................40
13 Disposal....................................................................40
14 Safety check / service.......................................40
15 Warranty..................................................................41
16 Start-up and trumpetcurves........................41
16.1 Significance in clinicalpractice ..................41
16.2 Typical start-up and trumpet curves ........42
16.3 Alarm times............................................................43
16.3.1 Intrafix® Primeline..................................................43
17 Technical data.......................................................44
18 Electromagnetic compatibility.....................47
18.1 Electromagnetic interference emissions ...48
18.2 Electromagnetic immunity.............................49
18.3 Recommended safe distances
between portableand mobile RF
telecommunications equipment
andtheInfusomat compactplus ...................53
19 Instructions for use for accessories...........54
19.1 Interface lead 12V CP (8718020)..............54
19.2 Interface lead staff call CP(8718030).....54
19.3 Stationcompactplus (8717141)....................54
19.4 Data module compactplus (8717160)........54
19.5 Short stand SP (8713135)..............................54
20 Ordering data........................................................56
20.1 Recommended accessories for
Infusomat® compact
plus P...............................56
20.2 Power cords............................................................56
20.3 Infusomat® compact
plus P lines ...................57
Index ......................................................................................58
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About this document
1 About this document
1.1 Purpose
These instructions for use are part of the
device and describe how to use the device
safely and correctly.
QRead these instructions for use before
using this device.
QKeep these instructions for use avail-
able near the device.
QRead and follow other applicable
documents.
1.2 Signs, symbols and tags
Symbol Meaning
QPrerequisite
QHandling step: Follow the
specied instructions.
Key > Key Press the specied keys
one after the other.
Warning symbol,
introduces a warning.
Note: Information to clarify or
optimise work processes
Bold Name of a navigational
or an input element
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About this document
1.3 Warnings
Symbol Meaning
DANGER
Danger for people.
Non-compliance will lead to death or serious injuries.
WARNING
Danger for people.
Non-compliance could lead to death or serious injuries.
CAUTION
Danger for people.
Non-compliance could lead to minor injuries.
CAUTION Risk of damage or incorrect operation.
Non-compliance could lead to material damage to the device
or to incorrect operation.
1.4 Abbreviations
Abbreviation Meaning
EMC Electromagnetic compatibility
KVO Keep vein open
SC Safety check
LED Light emitting diode
HF High frequency
ESD Electrostatic discharge
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Symbols
Symbol Meaning
Serial number
Date of manufacture
(year-month-day)
Manufacturer
Humidity limitation
Temperature limit
Atmospheric pressure
limitation
Not MRI safe
Medical Device
2 Symbols
2.1 Symbols on the product
and packaging
Symbol Meaning
Caution!
Consult instruction for use
Refer to instruction manual
(Follow instruction for use)
Labeling of electric and
electronic devices according
to directive 2002/96/EC
(WEEE)
CE marking according to
Directive 93/42/EEC
ECE test mark
Alternating current
Protective insulation;
protection class II device
Debrillation-proof type
CF applied part, see section
19.1 Accessories
Catalog number
Batch number
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Symbols
2.2 Symbols on the device’s display
Symbol Meaning
Delivery in progress
Delivery stopped
Mains connection/battery status
Pressure symbol (“manometer”):
Indication of P1 to P9
pressure level set with current system pressure (pointer)
Caution: Pre-alarm
Caution: Operating alarm
Infusion is above the upper soft limit
Infusion is below the lower soft limit
Pre-alarm temporarily muted
Active communication via Infrared
New Software or Drug Library update available
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Intended use
The Infusomat® compactplus P infusion
pump system is intended for use by quali-
ed healthcare professionals in rooms used
for medical purposes, inoutpatients and
in emergency and transport situations.
Theuser must have received training on the
device.
The use of the Infusomat® compactplus P
isdependent on the climatic conditions
specied in the technical data. The storage
conditions are detailed in the technical data.
3 Intended use
The Infusomat® compactplus infusion
pump system is a transportable volumetric
infusion pump used in combination with
specic infusion lines and accessories. The
pump is intended for use in adults, children
and neonates for the intermittent or con-
tinuous administration of parenteral and
enteral solutions.
The intended medical therapies include
predened or calculated infusion proles.
These are used for the delivery of medi-
cations and uids indicated for infusion
via intravenous, intra-arterial, irrigation,
subcutaneous, epidural, enteral route of
administration considered suitable by quali-
ed healthcare professionals with respect
to the technical data of the pump and
the prescribing information of the applied
medicinal product.
Contraindications are determined by the
administered medicinal products’ contra-
indications. There is no implied contra-
indication for the use of Infusomat®
compactplus.
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Safety instructions
4.1.3 Transport and storage
QDevices stored at temperatures above
and below the dened operating
conditions range must be kept at room
temperature for at least one hour
before being powered on.
QThe risk of transport damage cannot
be completely eliminated despite care-
ful packaging. Please check on delivery
that all items are present. Do not use
a damaged device. Contact the Service
department. Check that the device is
working correctly before its rst use.
This is even a legal requirement in sev-
eral countries. A corresponding form is
available from B.Braun.
4.1.4 Set-up and start-up
QFor mobile use (patient transport within
the clinic and outside the clinic), ensure
secure mounting or positioning of the
device. Changes of position and strong
vibrations can cause minor changes
in the delivery characteristics and/or
unintentional bolus administration.
QChanging the height during a running
infusion may lead to ow rate varia-
tions.
QEnsure that the device is properly posi-
tioned and secured, and that it is level.
QDo not position the device above the
patient.
QBefore switching on the device check
it, and the air sensor in particular, for
contamination, damage, missing parts
and functionality.
QPay attention to audible and visible
alarms, the lighting up of the two
4 Safety instructions
QRead the safety instructions before
using the device and observe them.
4.1 Safe handling
4.1.1 General
QMake sure that the introductory
training on the device is given by
a B.Braun sales representative or
another authorised person.
QAny serious incident that has occurred
in relation to this product should be
reported to B. Braun and the compe-
tent authority of the country in which
the product is operated.
QIf the device is dropped or subjected to
external forces: stop using the device
and have it tested by an authorised
service workshop.
QProtect the device against moisture.
QKeep the device clean.
QClose patient access in standby mode.
4.1.2 Software
QConsult the instructions for use fol-
lowing each software update to nd
out about the most recent changes to
the device and its accessories.
QEnsure that the software version on
the device corresponds to the version
these instructions for use refer to.
QEnsure that all devices used in a station
have the same software version
installed to avoid mistakes when using
dierently congured devices.
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Safety instructions
properly inserted and primed. Discon-
nect it from the patient when chang-
ing infusion line in order to prevent
unintended dose administration.
QOnly use approved infusion lines/
catheters for the intended medical use.
QPosition the infusion line to the patient
so that it does not have any kinks.
QEnsure that installation in rooms
used for medical purposes is done in
accordance with the regulations (e.g.,
VDE 0100, VDE 0107 and/or IEC speci-
cations). Observe all country-specic
regulations and national deviations.
QDo not operate the device near inam-
mable anaesthetics.
QAlways check the plausibility of the
values shown on the display.
QEnsure that there is additional patient
supervision (e.g. monitoring) if life sus-
taining drugs are administered.
QWhen administering highly-eective
drugs, have a second device ready for
the drug.
QAvoid mechanical eects on the
device. Ifthe device is moved while in
operation, the set delivery rate may be
exceeded/not be reached.
QIrrespective of the soft limit, ensure
that the values set for the patients are
the medically correct values.
QWhen using the device near equipment
that can cause higher interference
emissions (e.g. electrosurgical devices,
magnetic resonance imaging units,
mobile telephones) keep the device
the recommended safe distance away
from such equipment.
status LEDs and the display during
theself-test.
QWhen xing the device to a box rail,
donot x the device near the rail
bracket.
QFully charge the battery before the rst
use without an external power supply.
4.1.5 Stacking
QStack a maximum of three devices on
top of one another.
QDo not stack in ambulances.
QWhen stacking, ensure that the device
is correctly and safely locked in. You
will hear an audible click sound when
the device is locked in.
WARNING! The use of this device adja-
cent to or stacked with other equip-
ment has to be avoided. Nevertheless,
if adjacent or stacked use is necessary,
the Infusomat compact
plus P and the
other devices have to be observed to
verify normal operation in the con-
guration in which it will be used.
Note: A list of equipment with which the
Infusomat compact
plus P has been tested
in a stacked or adjacent conguration and
with which stacked or adjacent use is per-
mitted can be found in section20.1.
4.1.6 Operation
QStand in front of the device to operate
it. This ensures that you are able to
reach all control elements and that the
display is clearly visible.
QEstablish a connection to the patient
only after the infusion line has been
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Safety instructions
–Sta call cable compact
plus (8718030)
–Connection lead 12V (8718020)
–Short infusion stand (8713135)
–Accessories according to section 20.1
Note: Special informations with regard to
EMC are included in the separate instruc-
tion manuals for use for each relevant
accessory. Ensure adequate protection
against free-ow before changing dispos-
able items.
QHydrophobic lters can further reduce
the infusion of microbubbles.
QSee the corresponding manufacturer
information for possible incompatibili-
ties between the device and medicinal
products.
QUse only Luer lock, ENFit or NRFit
feed systems, and use only compatible
combinations of devices, accessories,
wear parts and disposable items.
QConnected electrical components must
comply with IEC/EN specications
(e.g.,IEC/DINEN 60950 for data pro-
cessing equipment). Anyone who con-
nects additional devices is considered
a system congurer, and is therefore
responsible for compliance with sys-
tem standard IEC/DINEN60601-1-1.
QWhere several infusion lines are con-
nected on one single vascular access,
the possibility of the lines exerting a
mutual inuence over each other
cannot be excluded.
Note: The use of untested or incompatible
disposable items can aect the technical
data. PUR lines can’t be used with the
device.
4.1.7 Alarms and sta call
QThe volume of the device’s acoustic
alarms can be adjusted for the envi-
ronmental conditions. This ensures
that the alarms are clearly audible.
QAlways monitor the pump alarms.
Theuse of the accessory cable or sta
call does not adequately replace moni-
toring the alarms.
4.1.8 Accessories and consumables
QIt is recommended that disposable
items are changed after 24hours
(seehygiene rules).
QOnly use pressure-tested disposable
items (min.2bar/1500 mmHg).
QOnly use the device with accessories
and articles that have been approved
for use with the device.
WARNING! The use of accessories,
transducers, power cords and cables
other than those specied, with the
exception of those sold by B.Braun
Melsungen AG as replacement parts
for internal components, may result
in increased emissions or decreased
immunity of the Infusomat
compactplus P.
Recommended equipment, accessories,
transducers and cables for which B.Braun
MelsungenAG claims compliance with
therequirements of the standards in
section 4.3:
–Perfusor® compact
plus (8717030)
–Infusomat compact plus (8717050)
–Station compact
plus (8717141)
–Cover compact
plus (8717145)
–Data module compact
plus (8717160)
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Safety instructions
4.1.9 Enteral nutrition
The Infusomat compactplus P can be used
for enteral nutrition.
QDo not use enteral uids for the intra-
venous infusion. This would lead to a
risk of severe injury or death for the
patient.
QOnly use ENFit feed systems that have
been designed and designated for
enteral nutrition.
4.2 Electrical connection
QDo not use the device if the plug has
visible damage.
QDo not use an extension cable that
has not been approved for use with
device. Position the power cable so
that it does not present a trip hazard.
4.3 Safety standards
QThe Infusomat compactplus P complies
with all safety standards for medical
electrical devices in accordance with
–IEC60601-1:2005
–IEC60601-1:2005/AMD1:2012
–IEC60601-1-6:2010
–IEC60601-1-6:2010/AMD1:2013
–IEC60601-1-8:2006
–IEC60601-1-8:2006/AMD1:2012
–IEC 60601-1-12:2014
–IEC60601-2-24:2012
QThe EMC limits (electromagnetic
compatibility) according to
–IEC60601-1-2:2007
–IEC60601-2-24:2012
are complied with.
Hinweis DTP 05-20
Ende Kapitel 4.1.8:
Achtung!
Die letzten Worte aus
der Anweisung der PDF
(in Klammern, BBM...)
wurden von mir nicht
eingesetzt. Wie ich denke
ist dies nur ein interner
Hinweis.
--> Bitte bestätigen.
Vollständiger Text der
Anweisung aus dem PDF:
Where several infusion
lines are connected
on one single vascular
access, the possibility
of the lines exerting a
mutual inuence over
each other cannot be
excluded (BBM Applica-
tion notes on parallel
infusion 38910004).
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Description of the device
5 Description of the device
5.1 Device overview
1 2 3 4 5
No. Name
1Air sensor
2Active safety clamp
3Pressure sensor
4Upstream sensor
5Passive safety clamp
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Description of the device
5.2 Interfaces
1 2 4 53
No. Name
1Pole clamp
2Accessory port (e.g. sta call, ambulance)
3Mains connection (socket for power cable. Inthe event of a power cut,
thedevice switches to battery mode automatically)
4Infrared interface (communication in station)
5Guide rails for connecting pumps
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Description of the device
5.3 Display and control elements
1 2 3 4 5 6 9 107 8
No. Element Meaning
1On/O key:
Switches the device on and o
2 Status display
Green LED: Delivery
Two-coloured LED (alarm indicator):
- Yellow LED: Pre-alarm (only if enabled in Service Tool)
- Red LED: Technical alarm, operating alarm
3Arrow keys:
QScroll through menus
QChange settings
QAnswer yes/no questions
QSelect scale values and change between digits when inputting
values
QOpen a function while the infusion is ongoing or suspended
4OK key:
QSelect/conrm function
QConrm value/settings/input/alarms
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Description of the device
No. Element Meaning
5Back key:
Return to the last display or last menu level
6Lock/unlock symbol:
The keypad is locked and unlocked by pressing and holding
down the menu key.
7Menu key:
Call up main menu and lock/unlock the device
8Info key:
Call up therapy data from the current infusion
9Bolus key:
Initiate bolus administration
10 Start/Stop key:
Start/stop the infusion
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Description of the device
5.5 Alarm status display
Alarms are displayed via a notication on
the display, asignal tone and a LED:
Yellow: Pre-alarm.
The alarm indicator LED lights up per-
manently in yellow.
Note: Yellow LED lights up only if
enabled in Service Tool
Red: Operating alarm.
The alarm indicator LED ashes in red.
QPress OK to acknowledge the alarm.
QContinue the therapy or start new
therapy.
5.4 Display overview
1
2
3
4
5
6
7
No. Display / Function
1 Moving arrows: Delivery in
progress (stopped delivery is
shown by two bars)
2Mains connection/battery
status
3Pressure symbol (“manometer”):
Indication of P1 to P9 pressure
level set with current system
pressure (pointer)
Note: Pressure detector is
also active when the device is
stopped or in standby mode.
4 Set delivery rate with drug
administration unit
5Volume already administered
during the current infusion
6Remaining volume for the
current infusion
7Remaining time for the current
infusion
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Menu structure/device functions
6.1.1 Main menu > Rate, volume & time
The device oers the option of entering the
delivery rate, avolume or a time limit. Ifthe
volume limit and infusion time are entered,
the rate will be calculated automatically.
6.1.2 Main menu > Drug
Menu Meaning
Stations Select station
Patient
prole
Select patient prole:
Default patient prole
or a previously created
prole
Categories Select drug categories
Drugs Select drug
Concentra-
tions
Select concentration
Note: All menu items except “Drug” are
optional and are only requested if there are
corresponding entries in the database.
6 Menu structure/
device functions
6.1 Main menu
Menu Meaning
Rate,
volume &
time
Enter/change infusion
rate or calculate rate by
entering the volume limit
and infusion duration
Drug Select the drug for the
intended use
Dose
calculation
Calculate the rate of
administration
Resetting
the therapy
Delete all therapy
settings
Note: the infused volume
(inf. vol.) is not deleted.
Device
options...
Congure the device
settings
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Menu structure/device functions
6.1.4 Main menu > Settings...
Menu Meaning
Night mode Turn night mode on/o
Brightness Enter brightness:
QLevel 1 (=lowest level)
- to -
QLevel 9 (=highest level)
Audio
Volume
Select the volume:
QLevel 1 (=lowest level)
- to -
QLevel 9 (=highest level)
Pressure
alarm
Select pressure level:
QLevel 1 (=lowest level)
- to -
QLevel 9 (=highest level)
Service … Congure additional
settings e.g.:
QLanguage
QDate
QTime
QBolus rate
QKVO
QNight schedule
QSystem info
QHistory
6.1.3 Main menu > Dose calculation
Menu Meaning
Dose unit Select unit:
Qmg
Qμg
Qng
QIU
QmEq
Qmmol
Active
substance
quantity
Set the concentration
by entering the quantity
of active substance and
volume
Volume
Calculate
using:
Weight:
QEnter the patient’s
weight
Body surface area:
QEnter the patient’s
weight and height
No patient data
Select
dose unit
e.g. mg/min or mmol/24 h
Enter dose Enter desired dose
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