Braun Perfusor compact plus User manual

Instructions for use
Version 1.0 English
Valid for software 002A
Perfusor®compactplus

3
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.......................................................... 7
2Symbols...................................................................... 8
2.1 Symbols on the product and
packaging.................................................................. 8
2.2 Symbols on the device‘sdisplay.................... 9
3Intended use..........................................................10
4Safety instructions.............................................11
4.1 Safe handling........................................................11
4.1.1 General.......................................................................11
4.1.2 Software ....................................................................11
4.1.3 Transport and storage............................................11
4.1.4 Set-up and start-up ...............................................11
4.1.5 Stacking.....................................................................11
4.1.6 Control........................................................................12
4.1.7 Alarms and staff call..............................................12
4.1.8 Accessories and consumables..............................13
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 powering on........................... 22
7.1 Setting up and connectingthe device.... 22
7.1.1 Attach/remove the compactplus
stand 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 with abattery................. 22
7.2 Powering on the device on
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 syringe ........................................ 26
8.3 Setting the infusion values........................... 26
8.3.1 Entering the delivery rate.................................... 26
8.4 Starting and stopping theinfusion............27
8.5 Activating standby.............................................27
8.6 Administering bolus.......................................... 28
8.6.1 Administering a manual bolus ........................... 28
8.6.2 Administering a bolus with preselected
bolusvolume/bolus duration.............................. 28
8.7 Using the drug database................................ 29
8.7.1 Hard and soft limits............................................... 29
8.8 Calculating the dose......................................... 30
8.9 Entering a combination ofdelivery rate,
volume and time..................................................31
8.10 Resetting the therapy...................................... 32
8.11 Changing the syringe....................................... 32
8.12 Ending the infusion........................................... 32

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8.13 Switching off the device................................ 33
8.14 Priming the infusion line................................ 33
9Alarms...................................................................... 34
9.1 Device alarms....................................................... 34
9.2 Pre-alarms and operating alarms.............. 34
9.2.1 Pre-alarms................................................................ 34
9.2.2 Operating alarms.................................................... 35
9.3 Reminder alarm................................................... 36
10 Cleaning and care...............................................37
10.1 Cleaning...................................................................37
10.2 Battery operation and maintenance.........37
10.2.1 Note for optimal battery operation...................37
10.2.2 Changing the battery............................................ 38
11 Decommissioning............................................... 38
12 Maintenance and repair................................. 38
13 Disposal................................................................... 39
14 Safety check/service......................................... 39
15 Start-up and trumpetcurves....................... 39
15.1 Significance in clinicalpractice ................. 39
15.2 Typical start-up and trumpet curves ....... 40
15.3 Alarm times...........................................................43
15.3.1 Omnifix® 50ml....................................................... 43
16 Technical data......................................................44
17 Electromagnetic compatibility.....................47
17.1 Electromagnetic interference
emissions................................................................48
17.2 Electromagnetic immunity............................ 49
17.3 Recommended safedistances ..................... 52
18 Instructions for use for accessories..........54
18.1 Interface lead 12V CP(8718020)............. 54
18.2 Staff call interface lead CP(8718030)...54
19 Ordering data....................................................... 56
19.1 Accessories............................................................ 56
19.1.1 Original Perfusor® lines........................................ 56
19.1.2 Interface lead.......................................................... 57
19.1.3 Syringes..................................................................... 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
available near the device.
QRead and follow other applicable
documents.
1.2 Signs, symbols and tags
Symbol Meaning
Key > Key Press the specied keys
one after the other.
Warning symbol,
introduces a warning.
Note: Information for a better
understanding or to
optimise work processes.
Bold Name of a navigational
or an input element

6
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.

7
About this document
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

8
Symbols
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
2012/19/EU (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
Symbol Meaning
Batch number
Serial number
Date of manufacture
(year-month-day)
Manufacturer
Humidity limitation
Temperature limit
Atmospheric pressure
limitation
Not MRI safe

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Symbols
2.2 Symbols on the device‘s display
Symbol Bedeutung
Delivery in progress
Delivery stopped
Mains electricity connection/battery status
Pressure symbol (“manometer”): Indication of P1 to P9 pressure level
set with current system pressure (pointer)
Attention: pre-alarm
Attention: operating alarm
Infusion is above the upper soft limit
Infusion is below the lower soft limit
Pre-alarm temporarily muted

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Intended use
3 Intended use
The Perfusor® compactplus infusion syringe
pump system is a transportable infusion
syringe pump used together with author-
ised syringes and accessories. The pump
is intended for use in adults, children and
newborns for the intermittent or continu-
ous administration of parenteral and enteral
solutions through standard medical access
routes. These access routes include, but are
not limited to, intravenous, intra-arterial,
subcutaneous, epidural and enteral routes.
The system can also be used to administer
drugs indicated for the infusion therapy.
These include, but are not limited to, anaes-
thetics, sedatives, analgesics, catechola-
mines etc.; blood or blood components;
solutions for total parenteral or enteral
nutrition and lipids.
A medical professional should decide on
specic applicability based on the guaran-
teed characteristics and technical data.
The Perfusor® compactplus infusion syringe
pump system is intended for use by quali-
ed medical professionals in rooms used
for medical purposes, inoutpatients and
in transport situations. The user must have
received training on the device. The use
of the Perfusor® compactplus is dependent
on the climatic conditions specied in the
technical data. The storage conditions are
detailed in the technical data.

11
Safety instructions
forat least one hour before being
powered on.
QDo not store the pump with the drive
head extended.
4.1.4 Set-up and start-up
QFor mobile use (patient transport
within the clinic and outside the clinic)
ensure secure mounting or position-
ing of the device. Changes of position
and strong vibrations can cause minor
changes in the delivery characteristics.
QEnsure that the device is properly posi-
tioned and secured, and that it is level.
QDo not position the device above the
patient.
QBefore powering on, check the device.
In particular, inspect the syringe
holder and claws for dirt, damage,
missing parts and to ensure that they
function correctly.
QPay attention to audible and visible
alarms and the lighting up of the two
status LEDS 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 or heli-
copters.
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.
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.
QIf the device is dropped or subjected to
external forces: stop using the device
and have it tested by an authorised
service workshop.
QAvoid external loads on the syringe
plate sensor.
QProtect the device against moisture.
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 sta-
tion have the same software version
installed to avoid mistakes when using
dierently congured devices.
4.1.3 Transport and storage
QDo not hold the device by the drive
head during transport.
QDevices stored at temperatures below
the dened operating conditions range
must be kept at room temperature

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Safety instructions
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.
QMonitor the administration of highly-
eective drugs accordingly.
QIrrespective of the soft limits, 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.
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 data communication via
an accessory cable or sta call does
not adequately replace monitoring
thealarms.
QCheck the sta call before each use
ofthe device.
4.1.6 Control
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.
QOnly connect the patient once the
syringe has been positioned correctly
and the syringe plunger plate is being
correctly held by the drive head claws.
Ensure adequate protection against
free-ow when changing syringes
in order to avoid an unwanted dose
administration.
QEnsure that the syringe plunger plate
sits ush with the drive head syringe
plate sensor.
QOnly use approved syringes/catheters
for their 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
sustaining drugs are administered.
QDo not apply any force to the drive
head during delivery as this could
trigger an alarm.

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Safety instructions
4.1.9 Enteral nutrition
The Perfusor® compactplus 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 disposable syringes 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.
QPosition the power cable so that it
does not present a trip hazard.
4.3 Safety standards
QThe device meets all safety standards
for medical electrical equipment in
compliance with IEC/DINEN 60601-1
and IEC/DINEN 60601-2-24.
QIt complies with the EMCthreshold
limits as specied in
IEC/DINEN60601-1-2 and
IEC/DINEN60601-2-24.
4.1.8 Accessories and consumables
QChange the disposables according to
your local infection control policy.
QOnly use pressure-tested disposable
items (min.2bar/1,500mmHg).
QOnly use the device with accessories
and consumables that have been
approved for use with the device.
QEnsure·adequate·protection·against·f
ree-ow before changing disposable
items.
QAlways use the device with the small-
est possible syringe, provided the
therapy permits this.
QSee the corresponding manufacturer
information for possible incompatibili-
ties between the device and medicinal
products.
Note: The use of untested or incompatible
disposable items can aect the technical
data.
QUse only Luer lock feed systems and
syringes as well as compatible device,
accessory, wear part and disposable
item combinations.
QConnected electrical components must
comply with IEC/EN specications
(e.g., IEC/EN 60950 for data process-
ing equipment). Anyone who connects
additional devices is considered a
system congurer, and is therefore
responsible for compliance with sys-
tem standard IEC/DINEN60601-1-1.
QIf more than one appliance/infusion
line is connected, mutual interference
cannot be ruled out .

14
Description of the device
5 Description of the device
5.1 Device overview
1 2 4 5 63
No. Name
1Syringe holder
2Syringe wings bracket
3Syringe plate sensor
4Claws
5Drive head with emergency lock key
6Release lever

15
Description of the device
5.2 Interfaces
1 2 4 53
No. Name
1Stand 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, service)
5Guide rails for connecting pumps

16
Description of the device
5.3 Display and control elements
1 2 3 4 5 6 9 107 8
No. Element Function
1On/o key:
Switches the device on and o
2Status display
Green LED: Delivery
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

17
Description of the device
No. Element Function
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

18
Description of the device
5.5 Alarm status display
Alarms are displayed via a notication on
the display, asignal tone and ashing of
thered LED (operating alarm):
Yellow: pre-alarm
Red: operating alarm
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
1Moving arrows:
Delivery in progress
(stopped delivery is shown by
two bars)
2Mains electricity 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.
4Set 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 Function
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
Concen-
trations
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 Function
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
Reset
therapy
Delete all therapy
settings
Note: the infused volume
(inf. vol.) is not deleted.
Settings... Congure the device
settings

20
Menu structure/ device functions
6.1.4 Main menu > Settings
Menu Function
Night mode Turning night mode on/o
Brightness Select the 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:
QLanguage
QDate
QTime
QBolus rate
QKVO
QNight schedule
QSystem info
QInfusion history
6.1.3 Main menu > Dose calculation
Menu Function
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