Perfusor ® ­compactplus

Instructions for use

Version 1.0 English
Valid for software 002A
Table of Contents

1 About this document........................................... 5 7 Set-up and powering on............................ 22

1.1 Purpose........................................................................ 5 7.1 Setting up and connecting the device..... 22
7.1.1 Attach/remove the c­ ompactplus
1.2 Signs, symbols and tags...................................... 5
stand clamp.............................................................. 22
1.3 Warnings.................................................................... 6 7.1.2 Operating the device on a stand........................ 22
1.4 Abbreviations........................................................... 7 7.1.3 Operating the device in the
2 Symbols....................................................................... 8 ­compactplus station................................................. 22
7.1.4 Operating the device on a wall rail.................... 22
2.1 Symbols on the product and
7.1.5 Connecting the device to the mains
packaging................................................................... 8 electricity................................................................... 22
2.2 Symbols on the device‘s display..................... 9 7.1.6 Operating the device with a battery................. 22
3 Intended use...........................................................10 7.2 Powering on the device on
for the first time.................................................. 22
4 Safety instructions.............................................. 11
7.3 Configure device options................................ 22
4.1 Safe handling......................................................... 11 7.3.1 Turning night mode on/off................................... 23
4.1.1 General........................................................................ 11 7.3.2 Setting display brightness.................................... 23
4.1.2 Software..................................................................... 11 7.3.3 Setting the Audio Volume.................................... 23
4.1.3 Transport and storage............................................. 11 7.3.4 Configuring the pressure alarm limit................ 23
4.1.4 Set-up and start-up................................................ 11 7.3.5 Configuring service settings.................................24
4.1.5 Stacking...................................................................... 11 7.4 Locking/unlocking the keypad...................... 25
4.1.6 Control........................................................................ 12
4.1.7 Alarms and staff call............................................... 12
8 Operation................................................................ 26
4.1.8 Accessories and consumables...............................13 8.1 Switching on the device.................................. 26
4.1.9 Enteral nutrition.......................................................13 8.2 Inserting the syringe......................................... 26
4.2 Electrical connection.........................................13 8.3 Setting the infusion values............................ 26
4.3 Safety standards...................................................13 8.3.1 Entering the delivery rate..................................... 26

5 Description of the device.................................14 8.4 Starting and stopping the infusion.............27

8.5 Activating standby..............................................27
5.1 Device overview....................................................14
8.6 Administering bolus........................................... 28
5.2 Interfaces.................................................................15
8.6.1 Administering a manual bolus............................ 28
5.3 Display and control elements........................16 8.6.2 Administering a bolus with preselected
5.4 Display overview...................................................18 bolus volume/bolus duration............................... 28
5.5 Alarm status display...........................................18 8.7 Using the drug database................................. 29
8.7.1 Hard and soft limits................................................ 29
6 Menu structure / device functions...............19
8.8 Calculating the dose.......................................... 30
6.1 Main menu..............................................................19
8.9 Entering a combination of delivery rate,
6.1.1 Main menu > Rate, volume & time....................19
volume and time..................................................31
6.1.2 Main menu > Drug..................................................19
6.1.3 Main menu > Dose calculation........................... 20 8.10 Resetting the therapy....................................... 32
6.1.4 Main menu > Settings........................................... 20 8.11 Changing the syringe........................................ 32
6.1.5 Settings > Service....................................................21 8.12 Ending the infusion............................................ 32

3


8.13 Switching off the device................................. 33 19 Ordering data........................................................ 56

8.14 Priming the infusion line................................. 33 19.1 Accessories............................................................. 56
19.1.1 Original Perfusor® lines......................................... 56
9 Alarms....................................................................... 34
19.1.2 Interface lead........................................................... 57
9.1 Device alarms........................................................ 34 19.1.3 Syringes...................................................................... 57
9.2 Pre-alarms and operating alarms............... 34
Index .................................................................................. 58
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 N ote 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 S ignificance 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

4
About this document

1 About this document 1.2 Signs, symbols and tags

1.1 Purpose Symbol Meaning

These instructions for use are part of the Key > Key Press the specified keys
device and describe how to use the device one after the other.
safely and correctly.
QQ Read these instructions for use before Warning symbol,
using this device. introduces a warning.
QQ Keep these instructions for use
Note: Information for a better
available near the device.
understanding or to
QQ Read and follow other applicable
optimise work processes.
documents.
Bold Name of a navigational
or an input element

5
About this document

1.3 Warnings

Symbol Meaning
Danger for people.
Non-compliance will lead to death or serious injuries.
DANGER
Danger for people.
Non-compliance could lead to death or serious injuries.
WARNING
Danger for people.
Non-compliance could lead to minor injuries.
CAUTION
CAUTION Risk of damage or incorrect operation.
Non-compliance could lead to material damage to the device or
to incorrect operation.

6
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

7
Symbols

2 Symbols
2.1 Symbols on the product
and packaging
Symbol Meaning Symbol Meaning
Caution! Batch number

Consult instruction for use Serial number

Refer to instruction manual Date of manufacture

(Follow instruction for use) (year-month-day)
Labeling of electric Manufacturer
and electronic devices
according to directive
2012/19/EU (WEEE) Humidity limitation
CE marking according to
Directive 93/42/EEC Temperature limit
ECE test mark
Atmospheric pressure
limitation
Alternating current

Protective insulation; Not MRI safe

protection class II device

Defibrillation-proof type CF
applied part, see section
19.1 Accessories
Catalog number

8
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

9
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

specific applicability based on the guaran-
teed characteristics and technical data.

The Perfusor® ­compactplus infusion syringe

pump system is intended for use by quali-
fied 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 specified in the
technical data. The storage conditions are
detailed in the technical data.

10
Safety instructions

4 Safety instructions for at least one hour before being

powered on.
QQ Read the safety instructions before QQ Do not store the pump with the drive
using the device and observe them. head extended.
4.1 Safe handling 4.1.4 Set-up and start-up

4.1.1 General
QQ For mobile use (patient transport
within the clinic and outside the clinic)
QQ Make sure that the introductory ensure secure mounting or position-
training on the device is given by ing of the device. Changes of position
a B. Braun sales representative or and strong vibrations can cause minor
another authorised person. changes in the delivery characteristics.
QQ If the device is dropped or subjected to QQ Ensure that the device is properly posi-
external forces: stop using the device tioned and secured, and that it is level.
and have it tested by an authorised QQ Do not position the device above the
service workshop. patient.
QQ Avoid external loads on the syringe QQ Before powering on, check the device.
plate sensor. In particular, inspect the syringe
QQ Protect the device against moisture. holder and claws for dirt, damage,
4.1.2 Software missing parts and to ensure that they
function correctly.
QQ Consult the instructions for use fol- QQ Pay attention to audible and visible
lowing each software update to find alarms and the lighting up of the two
out about the most recent changes to status LEDS during the self-test.
the device and its accessories. QQ When fixing the device to a box rail,
QQ Ensure that the software version on do not fix the device near the rail
the device corresponds to the version bracket.
these instructions for use refer to. QQ Fully charge the battery before the first
QQ Ensure that all devices used in a sta- use without an external power supply.
tion have the same software version
installed to avoid mistakes when using 4.1.5 Stacking
differently configured devices. QQ Stack a maximum of three devices on
4.1.3 Transport and storage top of one another.
QQ Do not stack in ambulances or heli-
QQ Do not hold the device by the drive copters.
head during transport. QQ When stacking, ensure that the device
QQ Devices stored at temperatures below is correctly and safely locked in. You
the defined operating conditions range will hear an audible click sound when
must be kept at room temperature the device is locked in.

11
Safety instructions

4.1.6 Control QQ When administering highly-effective

QQ Stand in front of the device to operate drugs, have a second device ready for
it. This ensures that you are able to the drug.
reach all control elements and that the
QQ Avoid mechanical effects on the
display is clearly visible. device. If the device is moved while in
QQ Only connect the patient once the operation, the set delivery rate may be
syringe has been positioned correctly exceeded/not be reached.
and the syringe plunger plate is being
QQ Monitor the administration of highly-
correctly held by the drive head claws. effective drugs accordingly.
Ensure adequate protection against
QQ Irrespective of the soft limits, ensure
free-flow when changing syringes that the values set for the patients are
in order to avoid an unwanted dose the medically correct values.
administration.
QQ When using the device near equipment
QQ Ensure that the syringe plunger plate that can cause higher interference
sits flush with the drive head syringe emissions (e.g. electrosurgical devices,
plate sensor. magnetic resonance imaging units,
QQ Only use approved syringes/catheters mobile telephones) keep the device
for their intended medical use. the recommended safe distance away
QQ Position the infusion line to the from such equipment.
patient so that it does not have any 4.1.7 Alarms and staff call
kinks. QQ The volume of the device‘s acoustic
QQ Ensure that installation in rooms
alarms can be adjusted for the envi-
used for medical purposes is done in
ronmental conditions. This ensures
accordance with the regulations (e.g.,
that the alarms are clearly audible.
VDE 0100, VDE 0107 and/or IEC speci- QQ Always monitor the pump alarms.
fications). Observe all country-specific
The use of data communication via
regulations and national deviations.
an accessory cable or staff call does
QQ Do not operate the device near inflam-
not adequately replace monitoring
mable anaesthetics.
the alarms.
QQ Always check the plausibility of the QQ Check the staff call before each use
values shown on the display.
of the device.
QQ Ensure that there is additional patient
supervision (e.g. monitoring) if life
­sustaining drugs are administered.
QQ Do not apply any force to the drive
head during delivery as this could
­trigger an alarm.

12
Safety instructions

4.1.8 Accessories and consumables 4.1.9 Enteral nutrition

QQ Change the disposables according to The Perfusor® ­compactplus can be used for
your local infection control policy. enteral nutrition.
QQ Only use pressure-tested disposable QQ Do not use enteral fluids for the intra-
items (min. 2 bar/1,500 mmHg). venous infusion. This would lead to a
QQ Only use the device with accessories risk of severe injury or death for the
and consumables that have been patient.
approved for use with the device. QQ Only use disposable syringes that have
QQ Ensure·adequate·protection·against·f been designed and designated for
ree-flow before changing disposable enteral nutrition.
items.
QQ Always use the device with the small- 4.2 Electrical connection
est possible syringe, provided the
therapy permits this. QQ Do not use the device if the plug has
QQ See the corresponding manufacturer visible damage.
information for possible incompatibili- QQ Do not use an extension cable that has
ties between the device and medicinal not been approved for use with device.
products. QQ Position the power cable so that it
does not present a trip hazard.
Note: The use of untested or incompatible
disposable items can affect the technical
data. 4.3 Safety standards
QQ Use only Luer lock feed systems and QQ The device meets all safety standards
syringes as well as compatible device, for medical electrical equipment in
accessory, wear part and disposable compliance with IEC/DIN EN 60601-1
item combinations. and IEC/DIN EN 60601-2-24.
QQ Connected electrical components must QQ It complies with the EMC threshold
comply with IEC/EN specifications limits as specified in
(e.g., IEC/EN 60950 for data process- IEC/DIN EN 60601‑1-2 and
ing equipment). Anyone who connects IEC/DIN EN 60601-2-24.
additional devices is considered a
system configurer, and is therefore
responsible for compliance with sys-
tem standard IEC/DIN EN 60601-1-1.
QQ If more than one appliance/infusion
line is connected, mutual interference
cannot be ruled out.

13
Description of the device

5 Description of the device

5.1 Device overview

1 2 3 4 5 6

No. Name
1 Syringe holder
2 Syringe wings bracket
3 Syringe plate sensor
4 Claws
5 Drive head with emergency lock key
6 Release lever

14
Description of the device

5.2 Interfaces

1 2 3 4 5

No. Name
1 Stand clamp
2 Accessory port (e.g. staff call, ambulance)
3 Mains connection (socket for power cable. In the event of a power cut, the
device switches to battery mode automatically)
4 Infrared interface (communication in station, service)
5 Guide rails for connecting pumps

15
Description of the device

5.3 Display and control elements

1 2 3 4 5 6 7 8 9 10

No. Element Function

1
On/off key:
Switches the device on and off

2 Status display
Green LED: Delivery
Red LED: Technical alarm, operating alarm

3
Arrow keys:
QQ Scroll through menus
QQ Change settings
QQ Answer yes/no questions
QQ Select scale values and change between digits when
inputting values
QQ Open a function while the infusion is ongoing
or suspended

4 OK key:
QQ Select/confirm function
QQ Confirm value/settings/input/alarms

16
Description of the device

No. Element Function

5
Back key:
Return to the last display or last menu level

6 Lock/unlock symbol:
The keypad is locked and unlocked by pressing and holding
down the menu key.
7
Menu key:
Call up main menu and lock/unlock the device

8
Info key:
Call up therapy data from the current infusion

9
Bolus key:
Initiate bolus administration

10
Start/Stop key:
Start/stop the infusion

17
Description of the device

5.4 Display overview 5.5 Alarm status display

1 Alarms are displayed via a notification on
4 the display, a signal tone and flashing of
2
the red LED (operating alarm):
Yellow: pre-alarm
3
5
6
7

No. Display / Function

1 Moving arrows:
Delivery in progress
(stopped delivery is shown by
two bars)
Red: operating alarm
2 Mains electricity connection/
battery status
3 Pressure 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
QQ Press OK to acknowledge the alarm.
QQ Continue the therapy or start new
5 Volume already administered ­therapy.
during the current infusion
6 Remaining volume for the
current infusion
7 Remaining time for the current
infusion

18
Menu structure / device functions

6 Menu structure / 6.1.1 Main menu >

Rate, volume & time
device functions
The device offers the option of entering the
6.1 Main menu 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 Select patient profile:
profile Default patient profile
or a previously created
profile
Menu Function
Categories Select drug categories
Rate, Enter/change infusion
volume & rate or calculate rate by Drugs Select drug
time entering the volume limit Concen- Select concentration
and infusion duration trations
Drug Select the drug for the
intended use Note: All menu items except “Drug” are
Dose Calculate the rate of optional and are only requested if there are
calculation administration corresponding entries in the database.

Reset Delete all therapy

therapy settings
Note: the infused volume
(inf. vol.) is not deleted.
Settings... Configure the device
settings

19
Menu structure / device functions

6.1.3 Main menu > Dose calculation 6.1.4 Main menu > Settings

Menu Function Menu Function

Dose unit Select unit: Night mode Turning night mode on/off
QQ mg
QQ μg Brightness Select the brightness:
QQ ng
QQ Level 1 (=lowest level)
QQ IU - to -
QQ mEq
QQ Level 9 (=highest level)
QQ mmol Audio Select the volume:
Active Set the concentration Volume QQ Level 1 (=lowest level)
substance by entering the quantity - to -
quantity of active substance and
QQ Level 9 (=highest level)
volume Pressure Select pressure level:
Volume
Alarm QQ Level 1 (=lowest level)
Calculate Weight: - to -
using: QQ Enter the patient’s QQ Level 9 (=highest level)
weight
Body surface area: Service … Configure additional
QQ Enter the patient‘s settings:
weight and height QQ Language
No patient data QQ Date
QQ Time
Select e.g. mg/min or mmol/24 h QQ Bolus rate
dose unit QQ KVO
Enter dose Enter desired dose
QQ Night schedule
QQ System info
QQ Infusion history

20
Menu structure / device functions

6.1.5 Settings > Service

After the service code has been entered, the
following service settings can be changed:

Menu Function
Language Select language:
QQ German
QQ English
Date Set date in DD.MM.YYYY
format
Time Set time
Bolus rate Enter default bolus rate
KVO Switch KVO on/off
Night Set night schedule:
schedule QQ On/off
QQ Activate at...
QQ Deactivate at...
System Display system information
info QQ Hardware version
QQ Software version
QQ Name of the drug file
QQ Time of next safety
check
QQ Station name
Infusion Displays a list of changes
history to the infusion settings

21
Set-up and powering on

7 Set-up and powering on 7.1.5 Connecting the device to

the mains electricity
7.1 Setting up and  ANGER! Risk of death from electric
D
connecting the device shock.

7.1.1 Attach/remove the ­compactplus

QQ Only connect the device to a mains
stand clamp power supply with a protective earth-
ing conductor.
Note: The c­ ompactplus stand clamp is fixed QQ Connect the power cable with mains
to the device. connection to the device.
QQ The ­compactplus stand clamp should QQ Position the power cable so that it
only be removed and re-attached by a does not present a trip hazard.
service technician. QQ Plug the mains plug into the socket.

7.1.2 Operating the device on a stand 7.1.6 Operating the device with
a battery
QQ Press the lever on the ­compactplus
stand clamp. QQ Ensure that the battery in the device is
Turn the c­ ompactplus stand clamp to sufficiently charged.
the desired position.
QQ Turn the c­ ompactplus static clamp until 7.2 Powering on the device on
the lever clicks into place.
for the first time
7.1.3 Operating the device in the QQ Device switched on
­compactplus station
QQ Select and insert the syringe,
QQ Follow the c­ ompactplus station instruc-
see section 8.2.
tions for use. QQ Configure additional device settings,
7.1.4 Operating the device on see section 7.3.
a wall rail
7.3 Configure device options
QQ Press the lever on the ­compactplus
stand clamp.
QQ Device switched on
Turn the c­ ompactplus stand clamp to
QQ No patient connected
the desired position.
QQ No ongoing infusion
QQ Turn the c­ ompactplus static clamp until QQ Press the Menu key.
the lever clicks into place. The main menu is displayed.
QQ Make sure that the c­ ompactplus stand QQ Select Settings... and press OK
clamp is not fixed at the point where to ­confirm.
the wall rail is attached to the wall. The “Settings” screen is displayed.

22
Set-up and powering on

7.3.4 Configuring the

pressure alarm limit
WARNING! Danger to the patient
from an incorrectly set pressure
alarm limit.
QQ Ensure that an appropriate pressure
level is selected in order to mini-
mize time to alarm.

It may be necessary to change the ­pressure

7.3.1 Turning night mode on/off
alarm limit due to various influencing fac-
In night mode the display brightness is tors, e.g. syringe friction, extension line
reduced. length and inner diameter, fluid viscosity
QQ Select Night mode and press OK and the filter used in the system set-up.
to confirm. Note: The set pressure level affects the time
QQ Select On/Off and press OK to alarm. In order to minimize the time to
to ­confirm. alarm, it is recommended that you start
7.3.2 Setting display brightness with a low pressure level and to increase if
required.
QQ Select Brightness and press OK
to confirm. Note: In the event of a pressure alarm, the
QQ Select brightness level and press OK post occlusion bolus will be automatically
to confirm. reduced.
–– Level 1 (=lowest level) QQ Select Pressure alarm and press OK
- to - to confirm.
–– Level 9 (=highest level) QQ Select alarm level and press OK
to confirm.
7.3.3 Setting the Audio Volume
–– Level 1 (=lowest level)
QQ Select Audio Volume and press OK - to -
to ­confirm. –– Level 9 (=highest level)
QQ Select Audio Volume level and press
OK to confirm.
–– Level 1 (=lowest level)
- to -
–– Level 9 (=highest level)

23
Set-up and powering on

Alarm level Pressure value 7.3.5 Configuring service settings

QQ Select Service... and press OK
1 0.100 bar (75 mmHg)
to ­confirm.
2 0.237 bar (178 mmHg) QQ Enter the service code and press OK
3 0.375 bar (281 mmHg) to ­confirm.
The “Service Menu” screen is dis-
4 0.512 bar (384 mmHg) played.
5 0.649 bar (487 mmHg)
6 0.787 bar (590 mmHg)
7 0.925 bar (694 mmHg)
8 1.063 bar (797 mmHg)
9 1.200 bar (900 mmHg)

Configuring the display language

QQ Select Language and press OK
to ­confirm.
QQ Select the language and press OK
to ­confirm.
Setting the date and time
QQ Select Date and press OK to ­confirm.
The set pressure level is shown with a P QQ Enter the day, month and year and
(for pressure) and a number. In addition, press OK to c­ onfirm.
a red area shows how quickly the set QQ Select Time and press OK to ­confirm.
pressure alarm limit will be reached. The QQ Enter the time and press OK
“manometer” display shows the current to ­confirm.
pressure in the system. The lower the set Setting the bolus rate
pressure alarm limit level is, the larger the
red area is, the quicker this limit is reached QQ Select Bolus rate and press OK
and a pressure alarm triggered. to ­confirm.
QQ Set the bolus rate and press OK
to ­confirm.

24
Set-up and powering on

Switching KVO on/off 7.4 Locking/unlocking

The pump can continue to deliver after a the keypad
preselected volume or a preselected time
Locking the keypad protects the device
with a pre-defined KVO rate (see s­ ection 16)
against accidental use.
has been reached. The duration of the KVO
delivery is established in the service program. QQ Ongoing infusion
QQ Select KVO and press OK to ­confirm.
QQ Select On/Off and press OK
QQ Press the menu key and hold for a
to ­confirm. few seconds to lock the keypad.
QQ The process for unlocking the keypad
Setting the night schedule is the same.
QQ Select Night schedule and press OK Note: The keypad lock is not activated for
to ­confirm. all keys. It is always possible to stop the
QQ Select On/Off and press OK infusion using the Start/Stop and On/Off
to ­confirm. keys.
QQ Select On/Off and press OK
to ­confirm.
QQ Select Activate and press OK
to ­confirm.
QQ Enter the time and press OK
to ­confirm.
QQ Select Deactivate and press OK
to ­confirm.
QQ Enter the time and press OK
to ­confirm.

25
Operation

8 Operation Note: “Support for bolus-free insertion”

does not release the user from their duty of
QQ Device settings configured care when changing the syringe.
8.1 Switching on the device Note: Always use the device with the small-
QQ Device connected to the mains elec- est possible syringe, provided the therapy
tricity or battery fully charged. permits this.
QQ Press the On/Off key on the device. Please see the notes in section 15.2
The device will perform a self-test: ­Typical start-up and trumpet curves.
Note: Pay attention to audible and visible
alarms, the lighting up of the two status
8.3 Setting the infusion values
LEDs and the display during the self-test. QQ Syringe inserted and selected
Note: Depending on the last therapy, the
8.2 Inserting the syringe pump can be set by using the delivery rate
QQ Device switched on. or by using drug library.

QQ Press the release lever and slide the 8.3.1 Entering the delivery rate
drive head to the right.
QQ Pull the syringe holder and turn it to
the left.
QQ Insert the syringe. Ensure that the
syringe wings have been correctly
inserted into the bracket.
QQ Pull the syringe holder and turn it to
its original position.
QQ Press the release lever and slowly slide
the drive head towards the syringe.
When the drive head reaches the QQ Enter the delivery rate using the arrow
syringe plunger plate, the syringe is keys.
automatically grasped. QQ Start the infusion with the Start/Stop
The “Select syringe” message is dis- key.
played. - or -
QQ Select syringe type and press OK QQ Press OK to ­confirm the rate.
to c­ onfirm. Make sure that the syringe The Overview screen is displayed.
type displayed is the same as the QQ Select Vol./Time and press OK
inserted syringe. to ­confirm.
QQ Enter the volume or time limit and
press OK to ­confirm.

26
Operation

Any values still missing are automati- 8.5 Activating standby

cally calculated and displayed.
In the event of longer interruptions, the
Note: In addition to the volume and time user has the option of retaining the set val-
limit, the infusion rate can also be adjusted ues and continuing the infusion at a later
in the Overview screen. time.
QQ Start the infusion with the Start/Stop
key. Activating standby mode
QQ Syringe inserted and selected
8.4 Starting and stopping
Press and hold the On/Off key until
the infusion
QQ

the pump display says it is in standby

QQ Values for the treatment set mode.
QQ Press the Start/Stop key to start the
infusion.
The moving arrows in the display and
the green LEDs show that the delivery
is taking place.

Adjusting device standby time

QQ Press the left arrow key.
QQ Enter the desired time and press OK
to ­confirm.

Note: The infusion rate set can be changed Ending standby mode
during an ongoing infusion by pressing the QQ Press the On/Off key or Back key.
OK key. QQ Press the Start/Stop key.
QQ Interrupt or stop the infusion by press- The delivery is re-started with the
ing the Start/Stop key to start a new ­previously set values.
therapy.
Note: After stopping the therapy, “Reset
therapy” must be selected in the menu
before a new therapy can be started.

27
Operation

8.6 Administering bolus Note: Manual bolus administration is lim-

ited to a max. 10 s or 10% of the syringe
There are three different options for bolus content. The bolus administration is auto-
administration: matically stopped, but it can be continued
QQ Manual bolus by pressing the Bolus key again.
QQ Bolus with preselection of the bolus
volume 8.6.2 Administering a bolus with
QQ Bolus with preselection of the bolus preselected bolus volume/bolus
volume and the bolus duration
duration
WARNING! Danger to the patient
from an overdose. At a bolus rate of
1,200 ml/h, 1 ml is reached after 3 s.
QQ Press the OK key to stop the bolus
administration.
QQ Press the Bolus key to access the bolus
menu.
Entering the bolus volume
Note: If the bolus administration is not QQ Press the left arrow key and enter the
started after the Bolus key is pressed, desired bolus volume.
the device automatically returns to the QQ Press the Bolus key to start the bolus
delivery screen for the ongoing infusion. administration.
Note: The pressure threshold is automati- Entering the bolus duration (optional)
cally increased during bolus administration.
QQ Press OK to ­confirm the entry of the
8.6.1 Administering a manual bolus bolus volume.
QQ Press the Bolus key.
QQ Select Bolus duration and press OK
The “Bolus” screen is displayed. to ­confirm.
QQ Press the Bolus key again and hold it.
QQ Entering the desired bolus duration.
Fluid is delivered as long as the key is The bolus rate is calculated.
pressed or until the maximum duration/
QQ Press the Bolus key.
dose have been reached. The delivered The bolus administration is started.
bolus volume is displayed. After the time has elapsed, the bolus
QQ Release the Bolus key. administration is ended and the infu-
The bolus administration is ended and sion continued.
the infusion continued.

28
Operation

8.7 Using the drug database QQ Start the infusion with the Start/Stop
key.
DANGER! Danger to the patient from - or -
incorrectly selected drug. QQ Confirm the delivery rate by pressing
QQ Ensure that the correct drug has OK.
been selected. The “Overview” screen is displayed.
QQ Select Vol./Time and press OK
Up to 3,000 freely selectable drug names,
to ­confirm.
including corresponding therapy data and
QQ Enter the volume or time limit and
information and up to 10 concentrations
press OK to ­confirm.
per drug in 30 categories, can be stored.
Any values still missing are automati-
The data are loaded using a separate PC
cally calculated and displayed.
programme.
The drug database can be used to select Note: In addition to the volume and time
a drug name with saved therapy data. limit, the infusion rate can also be adjusted
The procedure for selecting a drug is in the Overview screen.
described below: QQ Start the infusion with the Start/Stop
QQ Pump has just been switched on or key.
“Reset therapy” has been selected.
QQ Press the Menu key. 8.7.1 Hard and soft limits
The main menu is displayed.
QQ Select Drug and press OK to ­confirm. Hard limits
QQ If there is more than one profile avail­
Hard limits are fixed thresholds for the rate/
able:
–– Select station and press OK
dose/bolus volume and bolus rate stored in
the database. Only values within the hard
to ­confirm.
–– Select patient profile and press OK
limits can be entered.
If an attempt is made to exceed or go below
to ­confirm.
a hard limit, the following message appears
QQ Select drug category and press OK
on the display:
to ­confirm.
QQ Select drug and press OK to ­confirm.
QQ If avail­able, read the information in
the “Drug info” screen and press OK
to ­confirm.
QQ If necessary, select concentration and
press OK to ­confirm.
QQ Read the information in the “Drug”
screen and press OK to ­confirm.
QQ Enter the delivery rate.

29
Operation

Soft limits 8.8 Calculating the dose

Soft limits for rate/dose/bolus volume and The Dose calculation function is used to
bolus rate can also be stored in the data- calculate the delivery rate in ml/h based on
base. These can be exceeded but the fol- the dose parameters entered.
lowing message appears on the display.
QQ Syringe inserted and selected
QQ Press the Menu key.
The main menu is displayed.
QQ Select Dose calculation and press OK
to ­confirm.
QQ Select active substance unit and press
OK to ­confirm.
QQ Enter active substance quantity and
press OK to ­confirm.
QQ Enter volume and press OK to ­confirm.
The following symbols that describe the The “Calculate Using” screen is dis-
status of the pump with regard to the soft played.
limits are described:
Symbol Meaning
No Infusion is within the soft
symbol limits
Infusion is above the upper
soft limits

Infusion is below the lower

soft limits
Calculating without patient data
The delivery rate is calculated without any
patient data being entered.
QQ Select No patient data and press OK
to ­confirm.
QQ Select dose unit and press OK
to ­confirm.
QQ Enter dose.
Note: Pressing the OK key brings up the
Overview screen.

30
Operation

QQ Check the plausibility of the displayed QQ Enter dose.

values. The rate is automatically calculated.
QQ Start the infusion with the Start/Stop Note: Pressing the OK key brings up the
key. Overview screen.
Calculate using: Weight QQ Check the plausibility of the displayed
values.
QQ Select Weight and press OK to ­confirm. QQ Start the infusion with the Start/Stop
QQ Enter weight and press OK to ­confirm.
key.
QQ Select dose unit and press OK
to ­confirm.
QQ Enter dose. 8.9 Entering a combination
The rate is automatically calculated. of delivery rate, volume
Note: Pressing the OK key brings up the and time
Overview screen.
QQ Syringe inserted and selected
QQ Press the Menu key.
The main menu is displayed.
QQ Select Rate, volume & time and press
OK to ­confirm.
QQ Enter two of the following parameters
and press OK to ­confirm:
–– Rate
–– Volume
–– Time
QQ Check the plausibility of the displayed The third parameter is automatically
values. calculated.
QQ If necessary, enter the volume or time.
QQ Start the infusion with the Start/Stop If one or more parameters are entered,
key. changing a parameter has the following
effects on the other parameters.
Calculate using: Body surface area QQ Rate (or dose rate) changed:
–– If only the volume has been
QQ Select Body surface and press OK
to ­confirm. entered, the remaining time is
QQ Enter weight and press OK to ­confirm. adjusted.
–– If only the time has been entered,
QQ Enter the patient’s height and then
press OK to ­confirm. the remaining volume is adjusted.
–– If the volume and time have been
QQ Select dose unit and press OK
to ­confirm. entered, the remaining time is
adjusted.

31
Operation

QQ Volume changed: 8.11 Changing the syringe

–– If only the rate has been entered,
the remaining time is adjusted. Do not remove the syringe if the drive
–– If only the time has been entered, head claws are closed.
the rate (or dose rate) is adjusted. CAUTION! Damage to the syringe/
–– If the rate and time have been drive head claws.
entered, the remaining time is QQ Press the Start/Stop key to stop the
adjusted. infusion.
QQ Time changed: The green LED turns off.
–– If only the rate has been entered, QQ Ensure adequate protection against
the remaining volume is adjusted. free-flow.
–– If only the volume has been QQ Press the release lever and slide the
entered, the rate (or dose rate) is drive head to the right.
adjusted. QQ Pull the syringe holder and turn it to
–– If the rate and volume have been
the left. Hold the syringe while doing
entered, the remaining volume is so.
adjusted. QQ Remove the syringe.
QQ Insert the new syringe, see section 8.2.
8.10 Resetting the therapy QQ Start the infusion, see section 8.4.
The “Reset therapy” function is used to
delete all currently set therapy data. A new
8.12 Ending the infusion
therapy can be started.
Note: Reset therapy can only be selected if Do not remove the syringe if the drive
the therapy has been stopped. head claws are closed.
CAUTION! Damage to the syringe/
QQ Press the menu key and select drive head claws.
Reset therapy and press OK
to ­confirm. QQ Press the Start/Stop key to end the
QQ Press the up arrow key to reset the infusion.
therapy. The green LED turns off.
QQ Ensure adequate protection against
free-flow.
QQ Press the release lever and slide the
drive head to the right.
QQ Pull the syringe holder and turn it to
the left. Hold the syringe while doing
so.
QQ Remove the syringe.

32
Operation

Note: When removing a syringe if the 8.14 Priming the infusion line
syringe plunger plate is not released by the
claws, the emergency release button should Note: This function is not avail­able in the
be pressed. The emergency release button pump factory default. The function can
is on the outside of the drive head. It can be activated by a service technician on
be pressed using a pointed object (e.g. request.
ballpoint pen). Once it has been pressed QQ Connection to the patient removed
the claws can be opened by hand and the QQ Infusion stopped
syringe removed. Send the device to techni-
cal service. QQ Press the Bolus key.
The “Prime infusion line” screen is
QQ Return the syringe holder to original
displayed.
position
QQ Slide the drive head towards the pump
into parking position.

8.13 Switching off the device

QQ Infusion ended

Note: The device cannot be switched off if

a disposable item is inserted. Instead it will
go into standby mode. QQ Press the up arrow key to prime the
Ensure the drive head is in the parking posi- line.
tion. A message asking if the line is discon-
QQ Press the On/Off key for approx. nected from the patient is displayed.
1.5 seconds. QQ Press the up arrow key to start the
The device switches off. priming.
The disposable item is primed with the
maximum delivery rate.
Note: After successful priming, the line can
be primed again using the up arrow key.
QQ Press the down arrow key to end the
priming.

33
Alarms

9 Alarms 9.2.1 Pre-alarms

In the event of a pre-alarm, an acoustic
9.1 Device alarms signal sounds and a staff call is activated.
If a device alarm is triggered the infusion is The display remains in pre-alarm until the
stopped immediately. operating alarm goes off. Pre-alarms do not
QQ Press the On/Off key to switch off the cause delivery to be interrupted.
device. Display Meaning
QQ Switch the device on again. message
If there is another technical alarm:
QQ Disconnect the patient. “Volumes QQ Preselected volume
QQ Remove the disposable article. nearly infused” has almost been
QQ Switch off the device and send it to infused
the technical service. QQ Remaining volume
is displayed
9.2 Pre-alarms and operating “Disposable Small infusion volume
alarms syringe nearly remaining in the
empty” syringe
WARNING! Danger to the patient
from an incorrectly set alarm limits. “Infusion Preselected time is
QQ Ensure that the alarm limits are set time nearly almost over
so that the alarm can be triggered reached”
in good time. This applies for maxi-
“Battery The battery is almost
mum pressure in particular.
nearly empty” discharged
The operating alarm has a high priority.
Pre-alarms and reminder alarms have a A pre-alarm can be muted for 2 minutes by
lower priority. If there are two pre-alarms pressing the OK key. The following symbol is
at the same time, the pre-alarm with the shown in the display:
shorter remaining time is displayed.

The time lag between the triggering of the

alarm and the activation of a staff call is less
than a second and is therefore negligible.

If the power supply to the device is cut for

less than 30 seconds, the alarm information
is still retrievable because it is stored by
capacitors in the device.

34
Alarms

9.2.2 Operating alarms

In the event of an operating alarm, the infusion is stopped. An acoustic signal sounds,
the red LED flashes and a staff call is activated.

Display message Meaning

“Target volume Preselected volume has been infused
reached”
“Disposable No infusion solution is left in the syringe.
syringe is empty”
“Time reached” Preselected time has elapsed
“Battery empty” The battery is discharged
QQ Connect device to mains and/or have battery replaced by a
service technician
The battery alarm will sound for 3 min. Then the pump will
automatically turn off
“Pressure There is an occlusion in the system. The set level was exceeded
too high” QQ The pump automatically implements a bolus reduction
“KVO finished” KVO time has elapsed
“Syringe holder Syringe bracket was opened during the ongoing infusion
open” QQ Close syringe b­ racket
“Syringe not The wings of the syringe are not correctly inserted
correctly QQ Insert syringe correctly, see section 8.2
inserted”
“Calibrate device” Pump calibration data has changed (e.g. after an update)
QQ Recalibrate device using the service programme
“No battery It is not possible to use the pump without a battery
in the device” QQ Ask a service technician to insert a battery

35
Alarms

9.3 Reminder alarm

Reminder alarms are triggered in the follow-
ing cases:
QQ A syringe is inserted, the pump is not
delivering and the device is not oper-
ating for two minutes.
QQ A value input was started but not
completed and confirmed.
QQ After the standby time has elapsed
A staff call is activated and the following
screen is displayed:

36
Cleaning and care

10 Cleaning and care 10.2 Battery operation and

maintenance
QQ Device is switched off
QQ Device is unplugged from the mains The device is equipped with a modern lith-
QQ Device accessories are disconnected ium-ion battery that, at the time of delivery,
guarantees an operating time of 8 hours at
10.1 Cleaning 5 ml/h. For optimal treatment of the bat-
tery, the device is equipped with protection
QQ No pointed objects should be used for against overcharge and deep depletion.
cleaning. The battery is charged by the device during
QQ Do not put excess stress on the claws mains operation. In the event of a power
when cleaning. cut or disconnection from the mains, the
QQ Clean the surface of the device with pump automatically switches to battery
mild soap solution. mode.
QQ Do not spray disinfectant into the The battery status indicator in the display
­openings in the housing. is a trend display (low, medium, high).
QQ Do not use disinfectant spray on elec-
trical connections. Recommendation:
10.2.1 Note for optimal battery
Use disinfectants manufactured by
B. Braun (e.g., Meliseptol, Melsitt 10% operation
and Melsept SF 10%) for wipe disin- Battery life may vary due to
fection. QQ Ambient temperature
QQ Allow the device to air dry for at least QQ Varying loads
1 min before operation. Do not spray
into device openings (e.g., cooling Therefore, please observe the following:
vents, mains power plugs, interfaces). QQ Under normal temperature conditions,
QQ Observe all hygiene regulations. a battery can be fully discharged and
QQ Clean accessories according to the recharged around 300 times before its
instructions. capacity decreases to around half of
Note: Substances from the groups of disin- the original nominal value.
fectants listed below are approved, for normal
QQ When the device is in mains opera-
cleaning according to the manufacturer’s tion, the battery discharges slowly and
instructions: may be fully exhausted after a month
even if the device is not in operation.
Alcohols Peroxides In this case the battery does not reach
QAC Active chlorine its original capacity after one charge;
it takes several charging and discharg-
Aldehydes Acids
ing cycles for the battery to achieve
Alkylamines Phenoles its original capacity.

37
Decommissioning

QQ Optimal battery life will then only be 11 Decommissioning

achieved if the pump is in continu-
ous operation at room temperature QQ No ongoing therapy
in charged state. The battery display QQ No patient connected
on the pump is an approximate value
based on the current delivery rate. QQ Remove accessory parts and dispose
If the battery is old, the “battery of according to the instructions.
display” may differ from the actual QQ Switch off the device and disconnect
achievable operating time. from the mains.
QQ Prepare the device for storage or dis-
posal.
CAUTION! Risk of injury from the
–– Comply with the storage conditions.
battery exploding or leaking.
–– Follow the notes on disposal.
QQ Do not open or burn the battery.
10.2.2 Changing the battery 12 Maintenance and repair
QQ The battery should only be changed by
a service technician. WARNING! Risk of injury and/or
­malfunction from incorrect repair.
The device does not contain any parts
that the user can repair themselves.
QQ Do not repair defective devices
independently.
QQ Send defective devices to the
B. Braun service.

WARNING! Risk of injury and/or mal-

function from device modifications.
QQ Do not modify the device.

Note: Modifications and/or incorrect repair

of medical devices can lead to a loss of
guarantee/warranty claims and any author-
isations.

QQ Replace damaged accessories with

­original accessories.

38
Disposal

13 Disposal 15 Start-up and

The device should be returned to B. Braun
trumpet curves
for further disposal.
QQ Observe all country-specific regula- 15.1 Significance in
tions when disposing of equipment clinical practice
locally. Trumpet curves show the recorded maxi-
QQ Do not dispose of electrical devices mum and minimum deviations in flow rate
and batteries in domestic waste. compared to the delivery rate per time
interval.
14 Safety check/service In clinical practice, the trumpet curve
makes it easier for the treating doctor to
A safety check must be performed on the decide if the pump is sufficiently precise for
device every two years in accordance with the administration of the desired drug.
the checklist, with results entered into the QQ Reconcile drugs with short half lives,
medical device log. The service may only be
in particular, with the delivery accu-
performed by personnel who have received
racy in this period on the trumpet
training from B. Braun.
curve.
The physiological effect of the drug can
be affected by the flow and the disposable
article.
QQ Ensure that the prescription is in line
with the start-up/trumpet curve and
the set flow rate.

39
Start-up and trumpet curves

15.2 Typical start-up and

trumpet curves
Start-up curves
Anlaufkurven Trompetenkurven
Anlaufkurven Tromp
Flow Q(t) [ml/h]
Fluss [ml/h] Prozentualer
Fluss Flussfehler
Q(t) [ml/h]
Flow Q(t) [ml/h] Prozen
2,0 102,0 15
5 ml Omnifix 5 ml Omnifix
Delivery rate == 11 ml/h
Förderrate ml/h Förderraterate
Delivery = 1=ml/h
1 ml/h 10
1,5 51,5
Epmax 5

1 01 0
Epmin
-5
0,5 -5
0,5
-10

0 -10 0 -15
0:30 1:00 1:30 2:00 2 50:30 111:00 191:30 31 2:00 2
Zeit
Time[hh:mm]
[hh:mm] Zeit
Time[hh:mm]p x ∆t [min]
[hh:mm]
Beobachtungsfenster

Flow Q(t)
Fluss Q(t) [ml/h]
[ml/h] Prozentualer Flussfehler
Flow Q(t) [ml/h]
Fluss [ml/h] Prozen
2,0 10 15
20 ml Omnifix 20 ml Omnifix
Delivery rate == 11 ml/h
Förderrate ml/h Förderraterate
Delivery = 1 =ml/h
5 ml/h 10
1,5 5
Epmax 5

1 0 0
Epmin
-5
0,5 -5
-10
0 -10 0 -15
0:30 1:00 1:30 2:00 2 50:30 111:00 191:30 31 2:00 2
Zeit [hh:mm]
Time [hh:mm] Beobachtungsfenster p x ∆t [min]
Time[hh:mm]
Zeit [hh:mm]

Flow Q(t) [ml/h]

Fluss [ml/h] Prozentualer Flussfehler
10
20 ml Omnifix 20 ml Omnifix
Delivery rate == 55ml/h
Förderrate ml/h Förderrate = 5 ml/h
5
Epmax
0
Epmin

-5

0 -10
0:30 1:00 1:30 2:00 2 5 11 19 31
Time[hh:mm]
Zeit [hh:mm] Beobachtungsfenster p x ∆t [min]

40
 Start-up and trumpet curves

Trompetenkurven
Anlaufkurven
Trumpet curves Trompetenkurven
Percentage
Fluss Q(t)flow
Prozentualer error
Flussfehler
[ml/h] Prozentualer
Percentage Flussfehler
flow error
102,0 15 50 ml Omnifix
5 ml Omnifix
Delivery rate==11ml/h
Förderrate ml/h Förderrate
Delivery rate == 11 ml/h
ml/h
10
51,5
5
Epmax
Epmax
01 0
Epmin Epmin
-5
-5
0,5
-10

-10 0 -15
2:00 2 50:30 111:00 191:30 31 2:00 2 5 11 19 31
Zeitwindow
Observation [hh:mm]
Beobachtungsfenster pp xx ∆t
Δt [min] ∆t [min]
Observation window p x Δt
Beobachtungsfenster [min]

Percentage
Fluss Q(t) flow
Prozentualer error
Flussfehler
[ml/h] Percentage flow
Prozentualer error
Flussfehler
10 15
20 ml Omnifix 50 ml Omnifix
Delivery rate
Förderrate = 1=ml/h
1 ml/h Delivery rate == 55ml/h
Förderrate ml/h
10
5
Epmax 5
Epmax
0 0
Epmin Epmin
-5
-5
-10

-10 0 -15
2:00 2 50:30 111:00 191:30 31 2:00 2 5 11 19 31
ObservationZeit
window
Beobachtungsfenster pp xx ∆t
[hh:mm] Δt [min] ∆t [min]
Observation window p x Δt
Beobachtungsfenster [min]

Percentage flow
Prozentualer error
Flussfehler
10
20 ml Omnifix
Delivery rate
Förderrate = 5=ml/h
5 ml/h
Note: Every syringe has certain t­ olerances
5 in start-up behaviour (depending on the
Epmax syringe manufacturer, syringe plunger
0
Epmin
material, siliconisation of the cylinder etc.).
-5 In order to keep the delay as short as
­possible, the syringe should be as small
2:00
-10
2 5 11 19 31 as possible and the plunger moved before
Observation window pp xx ∆t
Beobachtungsfenster Δt [min] the syringe is inserted in order to work
through the rubber stopper’s breakloose
force behaviour.
The device is equipped with start accelera-
tion, which enables a quick infusion start
after each syringe change.
Note: Always use the device with the
smallest possible syringe, provided the
therapy permits this.

41
Start-up and trumpet curves

This is particularly important if highly Note: The system accuracy is normally

concentrated or life-sustaining drugs with ±2% of the volume, measured using the
short half-lives are to be infused at low trumpet curve test method according
infusion rates. to IEC 60601‑2-24 at a rate of 1 ml/h
(at 20 °C ± 2 °C) and using the recom-
When infusing at low rates and with large
mended syringes.
syringes, there can be deviations from
the pump‘s technical data, which can
lead to delivery deviations, delayed start- Start-up curves
up behaviour and longer alarm times in
Measurement interval Δt = 0.5 min
the event of system occlusions (pressure
alarms). Measurement duration T = 120 min

Recommendation Flow Qi (ml/h)

Syringe size [ml] 50/60 30 20

Trumpet curves
Recommended 1 1 0.5 (Measured values for second hour
minimum rate [ml/h] in each case)
Measurement interval Δt = 0.5 min
Recommendation
Observation interval p x Δt [min]
Syringe size [ml] 10 5 3

Recommended 0.1 0.05 0.01

minimum rate [ml/h]

These graphs show the accuracy and

uniformity of flow over time. Take into
account:
QQ The delivery behaviour and the
delivery accuracy are fundamentally
affected by the type of syringe used
(disposable item).
QQ Deviations from the pump technical
data cannot be ruled out for competi-
tors’ syringes.

42
Start-up and trumpet curves

15.3 Alarm times 15.3.1 Omnifix® 50 ml

Time(h:mm:ss)
Zeit [hh:mm:ss]
The following graphs show the alarm times 1:26:24
Omnifix® 50 ml
of the B. Braun syringe shown according to 1:12:00
1 ml/h
pressure and syringe type. 0:57:26

Note: The alarm times for syringes from 0:43:12

other manufacturers may vary slightly. 0:28:48

0:14:24
5 ml/h
0:00:00
P1 P5 Druckstufe
P9 Pressure level

Note: At a rate of 0.01 ml/h the alarm time

is > 4 h.

Manufactured by Syringe type Article number Pressure level = 1 Pressure level = 9

0.1 bar 1.2 bar
max. alarm times max. alarm times
[mm:ss] [mm:ss]
B. Braun OPS 50ml KK 8728810F-06 01:07 15:20
B. Braun OMNIFIX 50 KK 4617509F 01:31 14:24
B. Braun OMNIFIX 30 4617304F 00:52 09:28
B. Braun OPS 20ml 8728615 01:16 06:12
B. Braun OMNIFIX 20 4617207V 00:40 06:28
B. Braun OMNIFIX 10 4617100V 01:02 05:04
B. Braun OMNIFIX 5ml 4617053V 00:26 02:35
B. Braun OMNIFIX 3ml 4617022V 00:11 01:57
B. Braun OMNIFIX 2ml 4617029V 00:31 02:13
Terumo Terumo 50ml SS+50L1 03:07 22:43
Terumo Terumo 30ml SS*30LE1 02:24 13:58
Terumo Terumo 10ml SS*10LE1 01:20 05:30
Terumo Terumo 5ml SS*05LE1 01:08 03:45
Becton Dickinson Plastipak 50ml 300865/300869 04:48 19:20
Becton Dickinson Plastipak 30ml 301229 03:06 10:17
Becton Dickinson Plastipak 20ml 300629 02:44 10:34
Becton Dickinson Plastipak 10ml 305959 01:49 05:10
Becton Dickinson Plastipak 5ml 309649 00:16 02:22
Becton Dickinson Plastipak 3ml 309658 00:44 02:35
Fresenius Kabi AG Injectomat 50ml 9000701 06:21 23:42
Stanislaw Margol Margomed 50ml 007111, 007121 01:44 22:56
Becton Dickinson Precise 50ml A/P 300144 04:13 18:58
Becton Dickinson Precise 20ml A/P 300141 01:36 06:12
Becton Dickinson LuerLok 10ml A/P 302149 01:28 04:54
Becton Dickinson LuerLok 5ml A/P 302135 01:02 04:05
Becton Dickinson LuerLok 3ml A/P 302113 00:23 02:27

43
Technical data

16 Technical data
Note: The delivery accuracy, pressure alarm and alarm reaction times apply at room tem-
perature and with water as the test material. Different media viscosities and temperatures
may lead to deviations.

Parameter Value
Type of device Infusion syringe pump
Product classification According to Directive 93/42 EEC:
QQ IIb
According to EN 60601-1:
QQ Protection class II
QQ For Type CF applied parts with defibrillation protection
Moisture protection IP34
Power supply QQ 100-240 V, 50-60 Hz, connection via power cable or
­compactplus station
QQ 12 V DC 12 V CP interface cable
QQ 10 VA typ.
Internal battery Lithium-ion battery
QQ Battery life QQ Approx. 8 h at 5 ml/h with 50 ml syringe
QQ Recharging time QQ Approx. 4 h
Power consumption <20 W
Current consumption/ QQ Max. 0.6 Aeff (typ. <0.1 Aeff ) at
charging current 100-240 V, 50-60 Hz
QQ Max. 1.5 A (typ. <0.5 A) at 12 V DC
Staff call Max. 24 V / 0.5 A / 24 VA
(VDE 0834)
EMC IEC/EN 60601-1-2 / 60601-2-24
Time of operation 100% (continuous operation)
Acoustic alarm signal Nine avail­able levels:
sound pressure range 45 dB(A) to 75 dB(A)

44
Technical data

Parameter Value
Interfaces QQ Cold connector for mains voltage
QQ Accessory port for interface cable 12 V CP and staff call
QQ IrDA infrared for communication in the station and for
service
Operating conditions
QQ Temperature QQ +5 °C … +40 °C (+41 °F … +104 °F)
QQ Relative humidity QQ 30% … 90% (without condensation)
QQ Atmospheric pressure QQ 0.54 … 1.06 bar

Storage conditions
QQ Temperature QQ -20 °C … +55 °C (-4 °F … +131 °F)
QQ Relative humidity QQ 20 % … 90% (without condensation)
QQ Atmospheric pressure QQ 0.5 … 1.06 bar

Weight Approx. 2.3 kg

Dimensions in mm Approx. 290 mm x 98 mm x 220 mm
(W x H x D) (including ­compactplus stand clamp)
Safety check Every 2 years
Volume preselection 0.1 ml - 9,999 ml in increments of 0.01 ml
Time preselection 00:01 h - 99:59 h
Delivery accuracy ±2% according to IEC/EN 60601-2-24
Occlusion alarm pressure 9 levels from 1.2 bar ± 0.2 bar.
Post occlusion bolus will be automatically reduced.
Alarm in the case of In the event of an incorrect dose of max. 0.2 ml due to pump
incorrect dose malfunction, the pump will automatically switch off.
Max. bolus volume after ≤0.2 ml
bolus reduction

45
Technical data

Parameter Value
KVO rate QQ Rate: ≥ 10 ml/h: KVO rate 3 ml/h
QQ Rate: < 10 ml/h: KVO rate 1 ml/h
QQ Rate: < 1 ml/h: KVO rate = rate set using the service
program (factory default rate 0.1 ml/h) or current rate if
this is lower.
History protocol QQ 1,000 history entries
The oldest entries are overwritten if necessary.
QQ 100 events for system diagnosis
The history is retained when the device is switched off or
the battery removed.

Delivery rates
Continuous delivery rates/bolus rates according to the syringe size used:
Syringe size [ml] Continuous Bolus rate [ml/h] Preset bolus rate
delivery rate [ml/h] [ml/h]
50/60 0.01 to 200 1 to 1 800 800
Or alternatively:
0.01 to 999.9
30/35 0.01 to 100 1 to 1 200 600
20 0.01 to 100 1 to 800 400
10/12 0.01 to 50 1 to 500 200
5/6 0.01 to 50 1 to 300 150
2/3 0.01 to 25 1 to 150 80

Note: The delivery rate can be set in steps of 0.01 ml.

Note: The preset bolus rate can be changed via the service menu or once via the combination
of bolus volume and bolus time.
Delivery rate accuracy in bolus administration is generally ± 2%. The accuracy can vary
when administering low bolus volumes.

46
Electromagnetic compatibility

17 Electromagnetic
compatibility
Note: In order to meet with the following
compliance levels, only original accessories
and replacement parts may be used. Oth-
erwise, there may be elevated emissions or
reduced device immunity.
Note: If the device is used in a system
involving other devices (e.g. electrosurgery),
this system should be checked to ensure
correct operation of the system.
Note: The device must not be used near a
magnetic resonance imaging unit without
protection.
Note: The device must not be stacked,
placed or used immediately next to or with
other devices, except for B. Braun devices.
The device is designed to be used in the fol-
lowing electromagnetic environment. The
device users and customers should ensure
that it is being operated in such an environ-
ment.

47
Electromagnetic compatibility

17.1 Electromagnetic interference emissions

Interference emission Compliance Electromagnetic environment
measurements guidelines
HF emissions Group 1 The device uses HF energy for its internal
According to CISPR 11 functions only. As such, its HF emissions
rate is very low and it is unlikely to inter-
fere with nearby electronic equipment.
HF emissions Class B The device is intended for use in all
According to CISPR 11 establishments (including residential
Harmonic emissions Not areas and similar) directly connected to a
according to applicable public power grid that also supplies build-
IEC 61000-3-2 ings used for residential purposes.

Voltage fluctuation/flicker Conforms

emissions according to
IEC 61000-3-3

48
Electromagnetic compatibility

17.2 Electromagnetic immunity

The device is designed to be used in the electromagnetic environment described below. The
device users and customers should ensure that it is being operated in such an environment.
Immunity tests Test level Compliance Electromagnetic
EN 60601-1-2 level environment guidelines
EN 60601-2-24
Electrostatic Contact discharge Floors should be wood, con-
discharge (ESD) EN 60601-1-2: ±6 KV crete, or ceramic tile. If the
according to ±6 kV without floor covering is made of a
IEC 60601-4-2 interference synthetic material, relative
IEC 60601-2-24: ±8 KV outage air humidity needs to be at
±8 kV with alarm least 30%.
permitted
Air discharge
EN 60601-1-2: ±8KV without
±8 kV interference
IEC 60601-2-24: ±15KV outage
±15 kV with alarm
permitted
Electrical fast for power supply ±2 kV The supply voltage quality
transient/ bursts lines ±2 kV should be the same as that
according to of a typical commercial or
For input and output ±1 kV
IEC 60601-4-4 hospital environment.
lines ±1 kV
Surges according ±1 kV outer conduc- ±1 kV The supply voltage quality
to IEC 61000-4-5 tor - outer conduc- should be the same as that
tor voltage of a typical commercial or
hospital environment.
±2 kV voltage ±2 kV
Outer conductor -
ground

49
Electromagnetic compatibility

Immunity tests Test level Compliance Electromagnetic

EN 60601-1-2 level environment guidelines
EN 60601-2-24
Voltage dips, < 5% UT ¹ Complies The supply voltage quality
brief supply volt- for ½ periods through should be the same as that
age interruptions (>95% dip) the use of of a typical commercial or
and fluctuations an internal hospital environment.
40% UT ¹
according to energy source
for 5 periods
IEC 61000-4-11
(60% decline)
70 % UT ¹
for 25 periods
(30 % decline)
<5% UT ¹
for 5 s
(>95% dip)
Magnetic field at 3 A/m 400 A/m Magnetic fields at the
supply frequency supply frequency should
(50/60 Hz) correspond to those typi-
according to cally found in commercial
IEC 61000-4-8 and hospital environments.
Conducted HF 3 Veff 10 Veff Do not use portable and
interference 150 kHz to 80 MHz In all bands mobile radio communica-
according to Outside ISM bands tions equipment closer to
IEC 61000-4-6 the Perfusor® ­compactplus
10 Veff
(including connection
Within ISM bands
cables) than the recom-
mended safe distance
calculated using the appro-
priate equation for that
frequency.
Recommended safety
­distance: d = 1.2 √P³

50
Electromagnetic compatibility

Immunity tests Test level Compliance Electromagnetic

EN 60601-1-2 level environment guidelines
EN 60601-2-24
Radiated HF 10 V/m [E1] 10 V/m The field strength should be
interference 80 MHz to 80 MHz to lower than 10 V/m
according to IEC 2.5 GHz 6 GHz und
61000-4-3 500 MHz to 3 d = 12/E1 √P ²
GHz 80 MHz to 800 MHz
d = 23/E1 √P ²
800 MHz to 6 GHz
Field strengths from
stationary RF transmit-
ters should be below the
compliance level for all
frequencies, based on an
on-site test.
Interference is possible in
the vicinity of equipment
that has the following
symbol.

¹ UT is the AC mains voltage prior to test level application

² With P as the maximum rated power of the transmitter in watts (W) according to the trans-
mitter manufacturer specifications and as the recommended safe distance in metres (m).

51
Electromagnetic compatibility

Note: The deviating test values derived 17.3 Recommended

from IEC 60601-2-24 are labelled in the
table. However, these test values allow one
safe distances
outage with an alarm while the test values The device is designed for use in an electro-
according to DIN EN 60601-1-2 do not magnetic environment in which HF disrup-
allow any outages. tions are controlled. Customers or users of
the device can help avoid electromagnetic
The compliance levels for ISM frequency interference by maintaining a minimum
bands between 150 kHz and 80 MHz and distance between portable or mobile HF
in the 80 MHz to 6 GHz frequency range telecommunications equipment (transmit-
are designed to minimise the likelihood of ters) and the device – depending on the
mobile/portable communications equipment communication equipment’s output power,
causing interference if accidentally brought as described below.
into the patient area. For this reason the
additional factor 10/3 is used when calcu-
lating the recommended safe distances in
these frequency ranges.
Field strengths emitted from stationary
transmitters (such as base stations for
cordless telephones and land mobile radio
devices, amateur radio stations, or AM
and FM radio and television broadcasts)
theoretically cannot be predicted exactly.
Consider conducting a study of the site to
determine electromagnetic environmental
conditions as regards stationary transmit-
ters. If the measured field strength in the
area the Perfusor® ­compactplus is being
used in exceeds compliance levels, moni-
tor the Perfusor® ­compactplus to ensure
that it is functioning properly. If abnormal
performance is observed, additional meas-
ures may be necessary, e.g., changing the
device’s location or facing it in a different
direction.

52
Electromagnetic compatibility

Transmitter Safe distance according to transmitter frequency m

rated power
in W 150 kHz to 80 MHz ¹ 80 MHz to 800 MHz 800 MHz to 6 GHz ¹
1.2√P 1.2√P 2.3√P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.27

100 12 12 23
¹ The higher frequency range applies with 80 MHz and 800 MHz.

Note: Distances for transmitters whose the recommended safe distances in these
maximum rated power is not specified in frequency ranges.
the table above can be determined using
the equation for the relevant column, with
P being the transmitter’s maximum rated
power in watts (W) according to manufac-
turer specifications.

Note: These guidelines may not be appli-

cable in all cases. Electromagnetic propa-
gation is affected by the absorptive and
reflective qualities of the surrounding
structures, objects and people.

The compliance levels for ISM frequency

bands between 150 kHz and 80 MHz and
in the 80 MHz to 6 GHz frequency range
are designed to minimise the likelihood of
mobile/portable communications equip-
ment causing interference if accidentally
brought into the patient area. T­ herefore,
the additional factor 10/3 has been included
in the formula and used when calculating

53
Instructions for use for accessories

18 Instructions for use for 18.2 Staff call interface lead

accessories CP (8718030)
18.1 Interface lead 12 V Connect device to the staff call system

CP (8718020) The staff call system must comply with the

requirements of VDE 0834.
Connect the device for charging the QQ Observe country-specific regulations
battery with vehicle socket on staff calls.
QQ Plug the STAFF CALL interface lead
WARNING! Risk to the patient from CP into the accessory port on the side
electric shock! of the device or service port on the
QQ Do not use the device on patients ­compactplus station.
if the emergency ambulance is con- QQ Connect the STAFF CALL interface lead
nected to the vehicle charger. to the staff call system.
QQ Plug interface cable 12 V CP into the
QQ Set the staff call operating mode using
accessory port on the side of the the service programme. Follow the
device. staff call system procedure.
QQ Plug interface cable 12 V CP into the
QQ Check the staff call before each use of
vehicle socket. the device.
QQ If necessary, remove the red adapter
on the vehicle socket by gently turning
it and pulling on it at the same time.
The green LED on the electronics box
shows the operating voltage.

54
Instructions for use for accessories

The device has two different staff call operating modes:

Switched off Switched on Switched off

operating alarm
Static Alarm
without
off alarm *)
Operation

1 sec.
Dyn. Alarm
without
off alarm *)
Operation

* In “static without off alarm” mode, the staff call can be disabled by pressing the OK key.

55
Ordering data

19 Ordering data
Art. no. Name
8717030 Perfusor® ­compactplus

19.1 Accessories
Recommended accessories for the Perfusor® ­compactplus
19.1.1 Original Perfusor® lines
Art. no. Name
8255172 Original Perfusor® line, made of PVC; 50 cm
8722960 Original Perfusor® line, made of PVC; 150 cm
8722862 Original Perfusor® line, made of PVC; 200 cm
8255490 Original Perfusor® line, made of PVC; 250 cm
8255253 Original Perfusor® line, made of PVC; 300 cm
8255059 Original Perfusor® line, made of PE; 50 cm
8255067 Original Perfusor® line, made of PE; 100 cm
8722935 Original Perfusor® line, made of PE; 150 cm
8723060 Original Perfusor® line, made of PE; 200 cm
8272565 Original Perfusor® line, made of PE; 250 cm
8722820 Original Perfusor® line, type SafeSite, made of PVC,
with SafeSite safety connector; 150 cm
8723001 Original Perfusor® line, type Filter, made of PVC,
with 0.22 µm injection filter; 200 cm
8726019 Original Perfusor® line, type PCA, made of PVC,
with rotary nut lock; 168 cm
8722870 Original Perfusor® line, type MR, made of PVC, with rotary nut; 75 cm
8255504 Original Perfusor® line, type MR, made of PVC, with 150 cm
8723010 Original Perfusor® line, made of PE, black; 150 cm

56
Ordering data

19.1.2 Interface lead

Art. no. Name
8718020 Interface lead 12 V CP
8718030 Interface lead staff call CP

19.1.3 Syringes
Art. no. Name
8728615 Original Perfusor® syringe, 20 ml
8728623 Original Perfusor® syringe, 20 ml with needle
8728801F-06 Original Perfusor® syringe, 50 ml, protected against light,
yellow with filter needle
8728810F-06 Original Perfusor® syringe, 50 ml with needle
8728844F-06 Original Perfusor® syringe, 50 ml
8728852F-06 Original Perfusor® syringe, 50 ml with filter needle
8728861F-06 Original Perfusor® syringe, 50 ml, protected from light,
orange with filter needle
4617509F Omnifix® 50 ml
4617510F-06 Omnifix® 50 ml, protected from light, orange

Note: All syringes have a Luer lock attachment

for safety reasons.
Note: Depending on the syringe type and size,
there will be slight variations in the residual
volume in the syringe.

57
Index

A Drive head 14
Abbreviations 7 Drug database 19, 29
Accessories 13, 54, 56 E
Administering bolus 28
Alarm levels 24 Electrical connection 13
Alarms 12, 18, 34 Electromagnetic compatibility 47
Alarm status (display) 18 Electromagnetic immunity 49
Alarm times 43 Electromagnetic interference emissions 48
Ending the infusion 32
B Enteral nutrition 13
Battery operation 22, 37, 44 Enter time 19, 31
Battery operation and maintenance 37 Enter volume 19, 31
Bolus rate 21, 24
Bolus Time 28 F
Bolus volume 28 First start-up 22
Brightness (display) 20, 23 Fixing lever 14
C H
Changing the battery 38 Hard limits 29
Changing the syringe 32
I
Claws 14
Cleaning 37 Immunity (EMC) 49
Consumables 13 Inserting the syringe 26
Control 12 Intended use 10
Control elements 16 Interface lead 12 V CP 54, 57
Interface lead staff call CP 54, 57
D
Interfaces 15, 45
Date 21, 24 Interference emissions (EMC) 48
Decommissioning 38
Delivery accuracy 45 K
Delivery rate 19, 26, 31 Keypad lock 25
Description of the device 14 Keys 16
Device alarms 34 KVO 21, 25
Device options 20, 22
Device overview 14 L
Display brightness 20, 23 Language 21, 24
Display elements 16 LED 16
Display screen 18 Limits 29
Disposal 39 Lock (keypad) 25
Dose calculation 20, 30 Loudness 12, 20, 23

58
M Set-up 11, 22
Main menu 19 Soft limits 30
Mains connection 22 Software 11
Maintenance 37, 38 Stacking 11
Manual bolus 28 Staff call 12, 44
Menu structure 19 Standby 27
N Stand clamp 15, 22
Night mode 20, 23 Starting and stopping the infusion 27
Night schedule 21, 25 Start-up 11, 22
Start-up curves 39
O Station 22
Operating alarms 18, 35 Storage 11
Operating conditions 45 Storage conditions 45
Operation 26 Switch off 33
Ordering data 56
Switch on 26
P Symbols 5, 9
Perfusor® lines 56 Symbols on the device’s display 9
Plunger plate stop 14 Symbols on the product and packaging 8
Pre-alarms 18, 34 Syringe bracket 14
Pressure alarm limit 20, 23 Syringe fastening 14
Prime (infusion line) 33 Syringes 57
Priming the infusion line 33
Protection class 44 T
R Technical data 44
Temperature 45
Rate 19, 26, 31
Reminder alarm 36 Time 21, 24
Repair 38 Training 11
Reset (therapy) 32 Transport 11
Resetting the therapy 32 Trumpet curves 39
S U
Safe distance (EMC) 52 Unlock (keypad) 25
Safety check 39
W
Safety instructions 11
Safety standards 13 Wall rail 22
Service 39 Warnings 6
Service settings 21, 24

59
Manufactured by: Distributed by:
B. Braun Melsungen AG B. Braun Melsungen AG
34209 Melsungen Hospital Care Division
Germany 34209 Melsungen
Tel +49(0) 56 61 71-0 Germany
www.bbraun.com Tel +49 (0) 56 61 71-0
www.space.bbraun.com Fax: +49 (0) 56 61 71-20 44
www.bbraun.com

38932101 • Drawing no. I0002700001

2017-05-18 • Information as of: March 2017

Printed on 100% chlorine-free bleached pulp