Braun Perfusor compact plus Instructions For Use Manual

Perfusor

Instructions for use

Version 1.0 English

Valid for software 002A

®

compact

plus

Table of Contents

1 About this document .......................................... 5

1.1 Purpose ....................................................................... 5

1.2 Signs, symbols and tags ..................................... 5

1.3 Warnings ................................................................... 6

1.4 Abbreviations .......................................................... 7

2 Symbols ...................................................................... 8

2.1 Symbols on the product and
packaging

.................................................................. 8

2.2 Symbols on the device‘sdisplay .................... 9

3 Intended use ..........................................................10

4 Safety 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

5 Description 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

6 Menu 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

7 Set-up and powering on

7.1 Setting up and connectingthe device .... 22

7.1.1 Attach/remove the compact

stand clamp .............................................................

7.1.2 Operating the device on a stand........................ 22

7.1.3 Operating the device in the

7.1.4 Operating the device on awallrail ................... 22

7.1.5 Connecting the device to themains

7.1.6 Operating the device with abattery................. 22

plus

compact

electricity ..................................................................

station ................................................ 22

........................... 22

plus

22

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

8 Operation ............................................................... 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

3

8.13 Switching off the device ................................ 33

8.14 Priming the infusion line ................................ 33

9 Alarms ...................................................................... 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

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

................................................................ 48

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

4

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.

Q

Read these instructions for use before
using this device.

Q

Keep these instructions for use
available near the device.

Q

Read 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,

Note: Information for a better

Bold Name of a navigational

introduces a warning.

understanding or to
optimise work processes.

or an input element

5

About this document

1.3 Warnings

Symbol Meaning

Danger for people.

DANGER

WARNING

CAUTION
CAUTION Risk of damage or incorrect operation.

Non-compliance will lead to death or serious injuries.

Danger for people.
Non-compliance could lead to death or serious injuries.

Danger for people.
Non-compliance could lead to minor injuries.

Non-compliance could
toincorrect operation.

lead to material damage to

the device or

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

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

Symbol Meaning

Batch number

Serial number

Date of manufacture
(year-month-day)

Manufacturer

Humidity limitation

Temperature limit

Atmospheric pressure
limitation

Not MRI safe

Debrillation-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® compact
pump system
syringe pump used together with author­ised syringes and accessories. The pump
is intended for use in adults, children and
newborns for the intermittent or continu­ous 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, anaes­thetics, sedatives, analgesics, catechola­mines etc.; blood or blood components;
solutions for total parenteral or enteral
nutrition and lipids.

is a transportable infusion

plus

infusion syringe

A medical professional should decide on
specic applicability based on the guaran­teed characteristics and technical data.

The Perfusor® compact
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® compact
on the climatic conditions specied in the
technical data. The storage conditions are
detailed in the technical data.

10

plus

infusion syringe

plus

is dependent

Safety instructions

4 Safety instructions

Q

Read the safety instructions before
using the device and observe them.

4.1 Safe handling

4.1.1 General

Q

Make sure that the introductory
training on the device is given by
a B. Braun sales representative or
another authorised person.

Q

If the device is dropped or subjected to
external forces: stop using the device
and have it tested by an authorised
service workshop.

Q

Avoid external loads on the syringe
plate sensor.

Q

Protect the device against moisture.

Software

4.1. 2

Q

Consult the instructions for use fol­lowing each software update to nd
out about the most recent changes to
the device and its accessories.

Q

Ensure that the software version on
the device corresponds to the version
these instructions for use refer to.

Q

Ensure that all devices used in a sta­tion have the same software version
installed to avoid mistakes when using
dierently congured devices.

Transport and storage

4.1. 3

Q

Do not hold the device by the drive
head during transport.

Q

Devices stored at temperatures below
the dened operating conditions range
must be kept at room temperature

forat least one hour before being
powered on.

Q

Do not store the pump with the drive
head extended.

Set-up and start-up

4.1.4

Q

For mobile use (patient transport
within the clinic and outside the clinic)
ensure secure mounting or position­ing of the device. Changes of position
and strong vibrations can cause minor
changes in the delivery characteristics.

Q

Ensure that the device is properly posi­tioned and secured, and that it is level.

Q

Do not position the device above the
patient.

Q

Before 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.

Q

Pay attention to audible and visible
alarms and the lighting up of the two
status LEDS during the self-test.

Q

When xing the device to a box rail,
donot x the device near the rail
bracket.

Q

Fully charge the battery before the rst
use without an external power supply.

4.1.5 Stacking

Q

Stack a maximum of three devices on
top of one another.

Q

Do not stack in ambulances or heli­copters.

Q

When stacking, ensure that the device
is correctly and safely locked in. You
will hear an audible click sound when
the device is locked in.

11

Safety instructions

Control

4.1.6

Q

Stand 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.

Q

Only 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.

Q

Ensure that the syringe plunger plate
sits ush with the drive head syringe
plate sensor.

Q

Only use approved syringes/catheters
for their intended medical use.

Q

Position the infusion line to the
patient so that it does not have any
kinks.

Q

Ensure 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.

Q

Do not operate the device near inam­mable anaesthetics.

Q

Always check the plausibility of the
values shown on the display.

Q

Ensure that there is additional patient
supervision (e.g. monitoring) if life
sustaining drugs are administered.

Q

Do not apply any force to the drive
head during delivery as this could
trigger an alarm.

Q

When administering highly-eective
drugs, have a second device ready for
the drug.

Q

Avoid mechanical eects on the
device. Ifthe device is moved while in
operation, the set delivery rate may be
exceeded/not be reached.

Q

Monitor the administration of highly­eective drugs accordingly.

Q

Irrespective of the soft limits, ensure
that the values set for the patients are
the medically correct values.

Q

When 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.

Alarms and sta call

4.1.7

Q

The volume of the device‘s acoustic
alarms can be adjusted for the envi­ronmental conditions. This ensures
that the alarms are clearly audible.

Q

Always monitor the pump alarms.
Theuse of data communication via
an accessory cable or sta call does
not adequately replace monitoring
thealarms.

Q

Check the sta call before each use
ofthe device.

12

Safety instructions

4.1.8 Accessories and consumables

Q

Change the disposables according to
your local infection control policy.

Q

Only use pressure-tested disposable
items (min.2bar/1,500mmHg).

Q

Only use the device with accessories
and consumables that have been
approved for use with the device.

Q

Ensure·adequate·protection·against·f
ree-ow before changing disposable
items.

Q

Always use the device with the small­est possible syringe, provided the
therapy permits this.

Q

See the corresponding manufacturer
information for possible incompatibili­ties between the device and medicinal
products.

Note: The use of untested or incompatible

disposable items can aect the technical
data.

Q

Use only Luer lock feed systems and
syringes as well as compatible device,
accessory, wear part and disposable
item combinations.

Q

Connected electrical components must
comply with IEC/EN specications
(e.g., IEC/EN 60950 for data process­ing equipment). Anyone who connects
additional devices is considered a
system congurer, and is therefore
responsible for compliance with sys­tem standard IEC/DINEN60601-1-1.

Q

If more than one appliance/infusion
line is connected, mutual interference
cannot be ruled out

.

4.1.9 Enteral nutrition

The Perfusor® compact

plus

can be used for

enteral nutrition.

Q

Do not use enteral uids for the intra­venous infusion. This would lead to a
risk of severe injury or death for the
patient.

Q

Only use disposable syringes that have
been designed and designated for
enteral nutrition.

4.2 Electrical connection

Q

Do not use the device if the plug has
visible damage.

Q

Do not use an extension cable that has
not been approved for use with device.

Q

Position the power cable so that it
does not present a trip hazard.

4.3 Safety standards

Q

The device meets all safety standards
for medical electrical equipment in
compliance with IEC/DINEN 60601-1
and IEC/DINEN 60601-2-24.

Q

It complies with the EMCthreshold
limits as specied in
IEC/DINEN60601-1-2 and
IEC/DINEN60601-2-24.

13

Description of the device

1 2 4 5 63

5 Description of the device

5.1 Device overview

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

1 2 4 53

5.2 Interfaces

No. Name
1 Stand clamp
2 Accessory port (e.g. sta 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

1 2 3 4 5 6 9 107 8

5.3 Display and control elements

No. Element Function

1

On/o key:
Switches the device on and o

2

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

3

Arrow keys:

Q

Scroll through menus

Q

Change settings

Q

Answer yes/no questions

Q

Select scale values and change between digits when
inputting values

Q

Open a function while the infusion is ongoing
or suspended

4

16

OK key:

Q

Select/conrm function

Q

Conrm value/settings/input/alarms

Description of the device

No. Element Function

5

6

7

8

9

10

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

Lock/unlock symbol:
The keypad is locked and unlocked by pressing and holding
down the menu key.

Menu key:
Call up main menu and lock/unlock the device

Info key:
Call up therapy data from the current infusion

Bolus key:
Initiate bolus administration

Start/Stop key:
Start/stop the infusion

17

Description of the device

1

2

3

5.4 Display overview

No. Display / Function
1 Moving arrows:

Delivery in progress
(stopped delivery is shown by
two bars)

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.

5.5 Alarm status display

Alarms are displayed via a notication on

4

the display, asignal tone and ashing of
thered LED (operating alarm):

Yellow: pre-alarm

5

6

7

Red: operating alarm

4 Set delivery rate with drug

administration unit

5 Volume already administered

Q

Press OK to acknowledge the alarm.

Q

Continue the therapy or start new
therapy.

during the current infusion

6 Remaining volume for the

current infusion

7 Remaining time for the current

18

infusion