Braun Perfusor compact plus Instructions For Use Manual

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Page 1

Perfusor

Instructions for use

Version 1.0 English

Valid for software 002A

compact

plus

Page 2

Page 3

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

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 ..............................

8.7 Using the drug database ................................ 29

8.7.1 Hard and soft limits ............................................... 29

8.8 Calculating the dose ......................................... 30

8.9 Entering a combination ofdelivery rate,

volume and time..................................................31

8.10 Resetting the therapy ...................................... 32

8.11 Changing the syringe ....................................... 32

8.12 Ending the infusion ........................................... 32

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

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

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

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About this document

1 About this document

1.1 Purpose

These instructions for use are part of the device and describe how to use the device safely and correctly.

Read these instructions for use before using this device.

Keep these instructions for use available near the device.

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

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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

Page 7

About this document

1.4 Abbreviations

Abbreviation Meaning

EMC Electromagnetic compatibility

KVO Keep vein open SC Safety check LED Light emitting diode HF High frequency ESD Electrostatic discharge

Page 8

Symbols

2 Symbols

2.1 Symbols on the product

and packaging

Symbol Meaning

Caution!

Consult instruction for use

Refer to instruction manual (Follow instruction for use)

Labeling of electric and electronic devices according to directive 2012/19/EU (WEEE)

CE marking according to Directive 93/42/EEC

ECE test mark

Alternating current

Protective insulation; protection class II device

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

Page 9

Symbols

2.2 Symbols on the device‘s display

Symbol Bedeutung

Delivery in progress

Delivery stopped

Mains electricity connection/battery status

Pressure symbol (“manometer”): Indication of P1 to P9 pressure level set with current system pressure (pointer)

Attention: pre-alarm

Attention: operating alarm

Infusion is above the upper soft limit

Infusion is below the lower soft limit

Pre-alarm temporarily muted

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Intended use

3 Intended use

The Perfusor® 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.

plus

infusion syringe

plus

is dependent

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Safety instructions

4 Safety instructions

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

4.1 Safe handling

4.1.1 General

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

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

Avoid external loads on the syringe plate sensor.

Protect the device against moisture.

Software

4.1. 2

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

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

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

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

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.

Do not store the pump with the drive head extended.

Set-up and start-up

4.1.4

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.

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

Do not position the device above the patient.

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.

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

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

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

4.1.5 Stacking

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

Do not stack in ambulances or helicopters.

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.

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Safety instructions

Control

4.1.6

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.

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.

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

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

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

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.

Do not operate the device near inammable anaesthetics.

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

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

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

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

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.

Monitor the administration of highlyeective drugs accordingly.

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

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

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

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

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

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Safety instructions

4.1.8 Accessories and consumables

Change the disposables according to your local infection control policy.

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

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

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

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

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.

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

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.

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.

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

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

4.2 Electrical connection

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

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

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

4.3 Safety standards

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.

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

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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

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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

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Description of the device

1 2 3 4 5 6 9 107 8

5.3 Display and control elements

No. Element Function

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

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

Arrow keys:

Scroll through menus

Change settings

Answer yes/no questions

Select scale values and change between digits when inputting values

Open a function while the infusion is ongoing or suspended

OK key:

Select/conrm function

Conrm value/settings/input/alarms

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Description of the device

No. Element Function

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

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Description of the device

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

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

Yellow: pre-alarm

Red: operating alarm

4 Set delivery rate with drug

administration unit

5 Volume already administered

Press OK to acknowledge the alarm.

Continue the therapy or start new therapy.

during the current infusion

6 Remaining volume for the

current infusion

7 Remaining time for the current

infusion

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Menu structure / device functions

6 Menu structure /

device functions

6.1 Main menu

Menu Function

Rate, volume & time

Drug Select the drug for the

Dose calculation

Enter/change infusion rate or calculate rate by entering the volume limit and infusion duration

intended use Calculate the rate of

administration

6.1.1 Main menu >

Rate, volume & time

The device oers the option of entering the delivery rate, avolume or a time limit. Ifthe volume limit and infusion time are entered, the rate will be calculated automatically.

Main menu > Drug

6.1. 2

Menu Function Stations Select station

Patient prole

Categories Select drug categories Drugs Select drug

Concentrations

Note: All menu items except “Drug” are

optional and are only requested if there are corresponding entries in the database.

Select patient prole: Default patient prole or a previously created prole

Select concentration

Reset therapy

Settings... Congure the device

Delete all therapy settings

Note: the infused volume

(inf. vol.) is not deleted.

settings

Page 20

Menu structure / device functions

Main menu > Dose calculation

6.1. 3

Menu Function Dose unit Select unit:

μg

mEq

mmol

Active substance quantity

Volume

Calculate using:

Set the concentration by entering the quantity of active substance and volume

Weight:

Enter the patient’s weight

Body surface area:

Enter the patient‘s weight and height

No patient data

Select

e.g. mg/min or mmol/24 h

dose unit

Enter dose Enter desired dose

6.1.4 Main menu > Settings

Menu Function Night mode Turning night mode on/o Brightness Select the brightness:

Level 1 (=lowest level)

- to -

Level 9 (=highest level)

Audio Volume

Select the volume:

Level 1 (=lowest level)

- to -

Level 9 (=highest level)

Pressure Alarm

Select pressure level:

Level 1 (=lowest level)

- to -

Level 9 (=highest level)

Service … Congure additional

settings:

Language

Date

Time

Bolus rate

KVO

Night schedule

System info

Infusion history

Page 21

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:

German

English

Date Set date in DD.MM.YYYY

format

Time Set time Bolus rate Enter default bolus rate KVO Switch KVO on/o

Night schedule

System info

Infusion history

Set night schedule:

On/o

Activate at...

Deactivate at...

Display system information

Hardware version

Software version

Name of the drug le

Time of next safety check

Station name

Displays a list of changes to the infusion settings

Page 22

Set-up and powering on

7 Set-up and powering on

7.1 Setting up and

connecting the device

7.1.1 Attach/remove the compact

stand clamp

Note: The compact

to the device.

The compact only be removed and re-attached by a service technician.

Operating the device on a stand

7.1. 2

Press the lever on the compact stand clamp. Turn the compact the desired position.

Turn the compact the lever clicks into place.

Operating the device in the

7.1. 3

compact

Follow the compact tions for use.

Operating the device on

7.1. 4

a wall rail

Press the lever on the compact stand clamp. Turn the compact the desired position.

Turn the compact the lever clicks into place.

Make sure that the compact clamp is not xed at the point where the wall rail is attached to the wall.

plus

stand clamp is xed

plus

stand clamp should

plus

stand clamp to

plus

static clamp until

plus

station

plus

station instruc-

plus

stand clamp to

plus

static clamp until

plus

stand

plus

7.1. 5 Connecting the device to

the mains electricity

DANGER! Risk of death from electric

shock.

Only connect the device to a mains power supply with a protective earthing conductor.

Connect the power cable with mains connection to the device.

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

Plug the mains plug into the socket.

Operating the device with

7.1. 6

a battery

Ensure that the battery in the device is suciently charged.

7.2 Powering on the device on

for the rst time

Device switched on

Select and insert the syringe, see section 8.2.

Congure additional device settings, see section 7.3.

7.3 Congure device options

Device switched on

No patient connected

No ongoing infusion

Press the Menu key. The main menu is displayed.

Select Settings... and press OK to conrm. The “Settings” screen is displayed.

Page 23

Set-up and powering on

7.3.4 Conguring the

pressure alarm limit

WARNING! Danger to the patient

from an incorrectly set pressure alarm limit.

Ensure that an appropriate pressure level is selected in order to minimize time to alarm.

7.3.1 Turning night mode on/o

In night mode the display brightness is reduced.

Select Night mode and press OK toconrm.

Select On/O and press OK to conrm.

Setting display brightness

7.3.2

Select Brightness and press OK toconrm.

Select brightness level and press OK toconrm.

–

Level 1 (=lowest level)

- to -

–

Level 9 (=highest level)

Setting the Audio Volume

7.3.3

Select Audio Volume and press OK to conrm.

Select Audio Volume level and press OK toconrm.

–

Level 1 (=lowest level)

- to -

–

Level 9 (=highest level)

It may be necessary to change the pressure alarm limit due to various inuencing factors, e.g. syringe friction, extension line length and inner diameter, uid viscosity and the lter used in the system set-up.

Note: The set pressure level aects the time

to alarm. In order to minimize the time to alarm, it is recommended that you start with a low pressure level and to increase if required.

Note: In the event of a pressure alarm, the

post occlusion bolus will be automatically reduced.

Select Pressure alarm and press OK toconrm.

Select alarm level and press OK toconrm.

–

Level 1 (=lowest level)

- to -

–

Level 9 (=highest level)

Page 24

Set-up and powering on

Alarm level Pressure value 1 0.100 bar (75 mmHg) 2 0.237 bar (178 mmHg) 3 0.375 bar (281 mmHg) 4 0.512 bar (384 mmHg) 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)

The set pressure level is shown with aP (forpressure) and a number. Inaddition, ared area shows how quickly the set pressure alarm limit will be reached. The “manometer” display shows the current pressure in the system. The lower the set pressure alarm limit level is, the larger the red area is, the quicker this limit is reached and a pressure alarm triggered.

7.3. 5 Conguring service settings

Select Service... and press OK to conrm.

Enter the service code and press OK to conrm. The “Service Menu” screen is displayed.

Conguring the display language

Select Language and press OK to conrm.

Select the language and press OK to conrm.

Setting the date and time

Select Date and press OK to conrm.

Enter the day, month and year and press OK to conrm.

Select Time and press OK to conrm.

Enter the time and press OK to conrm.

Setting the bolus rate

Select Bolus rate and press OK to conrm.

Set the bolus rate and press OK to conrm.

Page 25

Set-up and powering on

Switching KVO on/o

The pump can continue to deliver after a preselected volume or a preselected time with a pre-dened KVO rate (see section16) has been reached. The duration of the KVO delivery is established in the service program.

Select KVO and press OK to conrm.

Select On/O and press OK to conrm.

Setting the night schedule

Select Night schedule and press OK to conrm.

Select On/O and press OK to conrm.

Select Activate and press OK to conrm.

Enter the time and press OK to conrm.

Select Deactivate and press OK to conrm.

Enter the time and press OK to conrm.

7.4 Locking/unlocking

the keypad

Locking the keypad protects the device against accidental use.

Ongoing infusion

Press the menu key and hold for a fewseconds to lock the keypad.

The process for unlocking the keypad is the same.

Note: The keypad lock is not activated for

all keys. Itis always possible to stop the infusion using the Start/Stop and On/O keys.

Page 26

Operation

8 Operation

Device settings congured

8.1 Switching on the device

Device connected to the mains electricity or battery fully charged.

Press the On/O key on the device. The device will perform a self-test:

Note: Pay attention to audible and visible

alarms, the lighting up of the two status LEDs and the display during the self-test.

8.2 Inserting the syringe

Device switched on.

Press the release lever and slide the drive head to the right.

Pull the syringe holder and turn it to the left.

Insert the syringe. Ensure that the syringe wings have been correctly inserted into the bracket.

Pull the syringe holder and turn it to its original position.

Press the release lever and slowly slide the drive head towards the syringe. When the drive head reaches the syringe plunger plate, the syringe is automatically grasped. The “Select syringe” message is displayed.

Select syringe type and press OK to conrm. Make sure that the syringe type displayed is the same as the inserted syringe.

Note: “Support for bolus-free insertion”

does not release the user from their duty of care when changing the syringe.

Note: Always use the device with the small-

est possible syringe, provided the therapy permits this. Please see the notes in section 15.2 Typicalstart-up and trumpet curves.

8.3 Setting the infusion values

Syringe inserted and selected

Note: Depending on the last therapy, the

pump can be set by using the delivery rate or by using drug library.

8.3.1

Entering the delivery rate

Enter the delivery rate using the arrow keys.

Start the infusion with the Start/Stop key.

- or -

Press OK to conrm the rate. The Overview screen is displayed.

Select Vol./Time and press OK to conrm.

Enter the volume or time limit and press OK to conrm.

Page 27

Operation

Any values still missing are automatically calculated and displayed.

Note: In addition to the volume and time

limit, the infusion rate can also be adjusted in the Overview screen.

Start the infusion with the Start/Stop

key.

8.4 Starting and stopping

the infusion

Values for the treatment set

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.

8.5 Activating standby

In the event of longer interruptions, the user has the option of retaining the set values and continuing the infusion at a later time.

Activating standby mode

Syringe inserted and selected

Press and hold the On/O key until the pump display says it is in standby mode.

Adjusting device standby time

Press the left arrow key.

Enter the desired time and press OK to conrm.

Note: The infusion rate set can be changed

during an ongoing infusion by pressing the OK key.

Interrupt or stop the infusion by pressing the Start/Stop key to start a new therapy.

Note: After stopping the therapy, “Reset

therapy” must be selected in the menu before a new therapy can be started.

Ending standby mode

Press the On/O key or Back key.

Press the Start/Stop key. The delivery is re-started with the previously set values.

Page 28

Operation

8.6 Administering bolus

There are three dierent options for bolus administration:

Manual bolus

Bolus with preselection of the bolus volume

Bolus with preselection of the bolus volume and the bolus duration

Note: If the bolus administration is not

started after the Bolus key is pressed, thedevice automatically returns to the delivery screen for the ongoing infusion.

Note: The pressure threshold is automati-

cally increased during bolus administration.

8.6.1

Administering a manual bolus

Press the Bolus key. The “Bolus” screen is displayed.

Press the Bolus key again and hold it. Fluid is delivered as long as the key is pressed or until the maximum duration/ dose have been reached. The delivered bolus volume is displayed.

Release the Bolus key. The bolus administration is ended and the infusion continued.

Note: Manual bolus administration is lim-

ited to a max. 10s or 10% of the syringe content. The bolus administration is automatically stopped, but it can be continued by pressing the Bolus key again.

8.6.2

Administering a bolus with preselected bolus volume/bolus 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.

Press the OK key to stop the bolus administration.

Press the Bolus key to access the bolus menu.

Entering the bolus volume

Press the left arrow key and enter the desired bolus volume.

Press the Bolus key to start the bolus administration.

Entering the bolus duration (optional)

Press OK to conrm the entry of the bolus volume.

Select Bolus duration and press OK to conrm.

Entering the desired bolus duration. The bolus rate is calculated.

Press the Bolus key. The bolus administration is started. After the time has elapsed, the bolus administration is ended and the infusion continued.

Page 29

Operation

8.7 Using the drug database

DANGER! Danger to the patient from

incorrectly selected drug.

Ensure that the correct drug has been selected.

Up to 3,000 freely selectable drug names, including corresponding therapy data and information and up to 10concentrations per drug in 30categories, can be stored. The data are loaded using a separate PC programme. The drug database can be used to select adrug name with saved therapy data. The procedure for selecting a drug is described below:

Pump has just been switched on or “Reset therapy” has been selected.

Press the Menu key. The main menu is displayed.

Select Drug and press OK to conrm.

If there is more than one prole available:

–

Select station and press OK to conrm.

–

Select patient prole and press OK to conrm.

Select drug category and press OK to conrm.

Select drug and press OK to conrm.

If avail able, read the information in the “Drug info” screen and press OK to conrm.

If necessary, select concentration and press OK to conrm.

Read the information in the “Drug” screen and press OK to conrm.

Enter the delivery rate.

Start the infusion with the Start/Stop key.

- or -

Conrm the delivery rate by pressing OK. The “Overview” screen is displayed.

Select Vol./Time and press OK to conrm.

Enter the volume or time limit and press OK to conrm. Any values still missing are automatically calculated and displayed.

Note: In addition to the volume and time

limit, the infusion rate can also be adjusted in the Overview screen.

Start the infusion with the Start/Stop

key.

8.7.1 Hard and soft limits

Hard limits

Hard limits are xed thresholds for the rate/ dose/bolus volume and bolus rate stored in the database. Only values within the hard limits can be entered. If an attempt is made to exceed

or go below a hard limit, the following message appears on the display

Page 30

Operation

Soft limits

Soft limits for rate/dose/bolus volume and bolus rate can also be stored in the database. These can be exceeded but the following message appears on the display.

The following symbols that describe the status of the pump with regard to the soft limits are described:

Symbol Meaning

No symbol

Infusion is within the soft limits

Infusion is above the upper soft limits

8.8 Calculating the dose

The Dose calculation function is used to calculate the delivery rate inml/h based on the dose parameters entered.

Syringe inserted and selected

Press the Menu key. The main menu is displayed.

Select Dose calculation and press OK to conrm.

Select active substance unit and press OK to conrm.

Enter active substance quantity and press OK to conrm.

Enter volume and press OK to conrm. The “Calculate Using” screen is displayed.

Infusion is below the lower soft limits

Calculating without patient data

The delivery rate is calculated without any patient data being entered.

Select No patient data and press OK to conrm.

Select dose unit and press OK to conrm.

Enter dose.

Note: Pressing the OK key brings up the

Overview screen.

Page 31

Operation

Check the plausibility of the displayed values.

Start the infusion with the Start/Stop

key.

Calculate using: Weight

Select Weight and press OK to conrm.

Enter weight and press OK to conrm.

Select dose unit and press OK to conrm.

Enter dose. The rate is automatically calculated.

Note: Pressing the OK key brings up the

Overview screen.

Check the plausibility of the displayed values.

If necessary, enter the volume or time.

Start the infusion with the Start/Stop

key.

Calculate using: Body surface area

Select Body surface and press OK to conrm.

Enter weight and press OK to conrm.

Enter the patient’s height and then press OK to conrm.

Select dose unit and press OK to conrm.

Enter dose. The rate is automatically calculated.

Note: Pressing the OK key brings up the

Overview screen.

Check the plausibility of the displayed values.

Start the infusion with the Start/Stop

key.

8.9 Entering a combination

of delivery rate, volume and time

Syringe inserted and selected

Press the Menu key. The main menu is displayed.

Select Rate, volume & time and press OK to conrm.

Enter two of the following parameters and press OK to conrm:

–

Rate

–

Volume

–

Time The third parameter is automatically calculated.

If one or more parameters are entered, changing a parameter has the following eects on the other parameters.

Rate (or dose rate) changed:

–

If only the volume has been

entered, the remaining time is

adjusted.

–

If only the time has been entered,

the remaining volume is adjusted.

–

If the volume and time have been

entered, the remaining time is

adjusted.

Page 32

Operation

Volume changed:

–

If only the rate has been entered, the remaining time is adjusted.

–

If only the time has been entered, the rate (or dose rate) is adjusted.

–

If the rate and time have been entered, the remaining time is adjusted.

Time changed:

–

If only the rate has been entered, the remaining volume is adjusted.

–

If only the volume has been entered, the rate (or dose rate) is adjusted.

–

If the rate and volume have been entered, the remaining volume is adjusted.

8.10 Resetting the therapy

The “Reset therapy” function is used to delete all currently set therapy data. Anew therapy can be started.

Note: Reset therapy can only be selected if

the therapy has been stopped.

Press the menu key and select Reset therapy and press OK

to conrm.

Press the up arrow key to reset the therapy.

8.11 Changing the syringe

Do not remove the syringe if the drive head claws are closed.

CAUTION! Damage to the syringe/

drive head claws.

Press the Start/Stop key to stop the infusion. The green LED turns o.

Ensure adequate protection against free-ow.

Press the release lever and slide the drive head to the right.

Pull the syringe holder and turn it to the left. Hold the syringe while doing so.

Remove the syringe.

Insert the new syringe, see section 8.2.

Start the infusion, see section 8.4.

8.12 Ending the infusion

Do not remove the syringe if the drive

head claws are closed.

CAUTION! Damage to the syringe/

drive head claws.

Press the Start/Stop key to end the infusion. The green LED turns o.

Ensure adequate protection against free-ow.

Press the release lever and slide the drive head to the right.

Pull the syringe holder and turn it to the left. Hold the syringe while doing so.

Remove the syringe.

Page 33

Operation

Note: When removing a syringe if the

syringe plunger plate is not released by the claws, the emergency release button should be pressed. The emergency release button is on the outside of the drive head. Itcan be pressed using a pointed object (e.g. ballpoint pen). Once it has been pressed the claws can be opened by hand and the syringe removed. Send the device to technical service.

Return the syringe holder to original position

Slide the drive head towards the pump into parking position.

8.13 Switching o the device

Infusion ended

Note: The device cannot be switched o if

a disposable item is inserted. Instead it will go into standby mode.

Ensure the drive head is in the parking position.

Press the On/O key for approx.

1.5seconds. The device switches o.

8.14 Priming the infusion line

Note: This function is not avail able in the

pump factory default. The function can be activated by a service technician on request.

Connection to the patient removed

Infusion stopped

Press the Bolus key. The “Prime infusion line” screen is displayed.

Press the up arrow key to prime the line. A message asking if the line is disconnected from the patient is displayed.

Press the up arrow key to start the 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.

Press the down arrow key to end the priming.

Page 34

Alarms

9 Alarms

9.1 Device alarms

If a device alarm is triggered the infusion is stopped immediately.

Press the On/O key to switch o the device.

Switch the device on again.

If there is another technical alarm:

Disconnect the patient.

Remove the disposable article.

Switch o the device and send it to the technical service.

9.2 Pre-alarms and operating

alarms

WARNING! Danger to the patient

from an incorrectly set alarm limits.

Ensure that the alarm limits are set so that the alarm can be triggered in good time. This applies for maximum pressure in particular.

9.2.1 Pre-alarms

In the event of a pre-alarm, anacoustic signal sounds and a sta call is activated. The display remains in pre-alarm until the operating alarm goes o. Pre-alarms do not cause delivery to be interrupted.

Display

Meaning

message

“Volumes nearly infused”

Preselected volume has almost been infused

Remaining volume is displayed

“Disposable syringe nearly empty”

“Infusion time nearly

Small infusion volume remaining in the syringe

Preselected time is almost over

reached”

“Battery nearly empty”

The battery is almost discharged

The operating alarm has a high priority. Pre-alarms and reminder alarms have a lower priority. Ifthere are two pre-alarms at the same time, the pre-alarm with the shorter remaining time is displayed.

The time lag between the triggering of the alarm and the activation of a sta 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.

A pre-alarm can be muted for 2 minutes by pressing the OK key. The following symbol is shown in the display:

Page 35

Alarms

9.2.2 Operating alarms

In the event of an operating alarm, the infusion is stopped. Anacoustic signal sounds, thered LED ashes and a sta 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

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 o

“Pressure too high”

There is an occlusion in the system. The set level was exceeded

The pump automatically implements a bolus reduction

“KVO nished” KVO time has elapsed

“Syringe holder open”

“Syringe not correctly

Syringe bracket was opened during the ongoing infusion

Close syringe bracket The wings of the syringe are not correctly inserted

Insert syringe correctly, see section 8.2

inserted” “Calibrate device” Pump calibration data has changed (e.g.after an update)

Recalibrate device using the service programme

“No battery in the device”

It is not possible to use the pump without a battery

Ask a service technician to insert a battery

Page 36

Alarms

9.3 Reminder alarm

Reminder alarms are triggered in the following cases:

A syringe is inserted, the pump is not delivering and the device is not operating for two minutes.

A value input was started but not completed and conrmed.

After the standby time has elapsed

A sta call is activated and the following screen is displayed:

Page 37

Cleaning and care

10 Cleaning and care

Device is switched o

Device is unplugged from the mains

Device accessories are disconnected

10.1 Cleaning

No pointed objects should be used for cleaning.

Do not put excess stress on the claws when cleaning.

Clean the surface of the device with mild soap solution.

Do not spray disinfectant into the openings in the housing.

Do not use disinfectant spray on electrical connections. Recommendation: Use disinfectants manufactured by B. Braun (e.g., Meliseptol, Melsitt10% and Melsept SF10%) for wipe disinfection.

Allow the device to air dry for at least 1min before operation. Donot spray into device openings (e.g., cooling vents, mains power plugs, interfaces).

Observe all hygiene regulations.

Clean accessories according to the instructions.

Note: Substances from the groups of disin-

fectants listed below are approved, for normal cleaning according to the manufacturer’s instructions:

Alcohols Peroxides

QAC Active chlorine

Aldehydes Acids

Alkylamines Phenoles

10.2 Battery operation and

maintenance

The device is equipped with a modern lithium-ion battery that, atthe time of delivery, guarantees an operating time of 8hours at 5ml/h. For optimal treatment of the battery, the device is equipped with protection against overcharge and deep depletion. The battery is charged by the device during mains operation. Inthe event of a power cut or disconnection from the mains, the pump automatically switches to battery mode. The battery status indicator in the display isa trend display (low, medium, high).

Note for optimal battery

10.2.1

operation

Battery life may vary due to

Ambient temperature

Varying loads

Therefore, please observe the following:

Under normal temperature conditions, abattery can be fully discharged and recharged around 300 times before its capacity decreases to around half of the original nominal value.

When the device is in mains operation, the battery discharges slowly and may be fully exhausted after a month even if the device is not in operation. Inthis case the battery does not reach its original capacity after one charge; ittakes several charging and discharging cycles for the battery to achieve its original capacity.

Page 38

Decommissioning

Optimal battery life will then only be achieved if the pump is in continuous operation at room temperature in charged state. The battery display on the pump is an approximate value based on the current delivery rate. Ifthe battery is old, the “battery display” may dier from the actual achievable operating time.

CAUTION! Risk of injury from the

battery exploding or leaking.

Do not open or burn the battery.

11 Decommissioning

No ongoing therapy

No patient connected

Remove accessory parts and dispose of according to the instructions.

Switch o the device and disconnect from the mains.

Prepare the device for storage or disposal.

–

Comply with the storage conditions.

–

Follow the notes on disposal.

10.2.2

Changing the battery

The battery should only be changed by a service technician.

12 Maintenance and repair

WARNING! Risk of injury and/or

malfunction from incorrect repair.

The device does not contain any parts that the user can repair themselves.

Do not repair defective devices independently.

Send defective devices to the B. Braun service.

WARNING! Risk of injury and/or mal-

function from device modications.

Do not modify the device.

Note: Modications and/or incorrect repair

of medical devices can lead to a loss of guarantee/warranty claims and any authorisations.

Replace damaged accessories with original accessories.

Page 39

Disposal

13 Disposal

The device should be returned to B. Braun for further disposal.

Observe all country-specic regulations when disposing of equipment locally.

Do not dispose of electrical devices and batteries in domestic waste.

14 Safety check/service

A safety check must be performed on the device every two years in accordance with the checklist, with results entered into the medical device log. The service may only be performed by personnel who have received training from B. Braun.

15 Start-up and

trumpet curves

15.1 Signicance in

clinical practice

Trumpet curves show the recorded maximum and minimum deviations in ow rate compared to the delivery rate per time interval. In clinical practice, the trumpet curve makes it easier for the treating doctor to decide if the pump is suciently precise for the administration of the desired drug.

Reconcile drugs with short half lives, inparticular, with the delivery accuracy in this period on the trumpet curve.

The physiological eect of the drug can be aected by the ow and the disposable article.

Ensure that the prescription is in line with the start-up/trumpet curve and the set ow rate.

Page 40

Start-up and trumpet curves

-10

-5

50 ml Omnifix

Förderrate = 1 ml/h

-15

Epmax

Epmin

0,5

1,5

2,0

2 5 11 19

Beobachtungsfenster p x ∆t [min]

Zeit [hh:mm]

Prozentualer Flussfehler

-10

-5

50 ml Omnifix

Förderrate = 5 ml/h

-15 2 5 11 19

Beobachtungsfenster p x ∆t [min]

Prozentualer Flussfehler

Epmax

Epmin

Anlaufkurven Trompetenkurven

0,5

1,5

2,0

-10

-5

2 5 11 19

Beobachtungsfenster p x ∆t [min]

Prozentualer Flussfehler

-10

-5

2 5 11 19

Beobachtungsfenster p x ∆t [min]

Prozentualer Flussfehler

Epmax

Epmin

Epmax

Epmin

Zeit [hh:mm]

Anlaufkurven Trompetenkurven

20 ml Omnifix

Förderrate = 1 ml/h

20 ml Omnifix

Förderrate = 5 ml/h

-10

-5

2 5 11 19

Beobachtungsfenster p x ∆t [min]

Prozentualer Flussfehler

Epmax

Epmin

5 ml Omnifix

Förderrate = 1 ml/h

0,5

1,5

2,0

15.2 Typical start-up and

trumpet curves

Start-up curves

Flow Q(t) [ml/h]

Fluss Q(t) [ml/h]

5 ml Omnifix

Förderrate = 1 ml/h

Delivery rate = 1 ml/h

Fluss Q(t) [ml/h]

Flow Q(t) [ml/h]

Delivery rate = 1 ml/h

Flow Q(t) [ml/h]

Fluss Q(t) [ml/h]

Flow Q(t) [ml/h]

Fluss Q(t) [ml/h]

0:30 1:00 1:30 2:00

Zeit [hh:mm]

Time [hh:mm]

20 ml Omnifix

Delivery rate = 1 ml/h

Förderrate = 1 ml/h

0:30 1:00 1:30 2:00

Zeit [hh:mm]

Time [hh:mm]

20 ml Omnifix

Förderrate = 5 ml/h

Delivery rate = 5 ml/h

0:30 1:00 1:30 2:00

Time [hh:mm]

Flow Q(t) [ml/h]

Fluss Q(t) [ml/h]

0:30 1:00 1:30 2:00

Zeit [hh:mm]

Time [hh:mm]

Delivery rate = 5 ml/h

0:30 1:00 1:30 2:00

Time [hh:mm]

Page 41

Start-up and trumpet curves

∆

Beobachtungsfenster p x ∆t [min]

Trumpet curves

Percentage flow error

Prozentualer Flussfehler

-5

-10 2 5 11 19

Percentage flow error

Prozentualer Flussfehler

-5

-10

2 5 11 19

Prozentualer Flussfehler

Percentage flow error

-5

-10 2 5 11 19

5 ml Omnifix

Delivery rate = 1 ml/h

Förderrate = 1 ml/h

Epmax

Epmin

Observation window p x Δt [min]

Beobachtungsfenster p x ∆t [min]

20 ml Omnifix

Delivery rate = 1 ml/h

Förderrate = 1 ml/h

Epmax

Epmin

Observation window p x Δt [min]

Beobachtungsfenster p x ∆t [min]

20 ml Omnifix

Förderrate = 5 ml/h

Delivery rate = 5 ml/h

Epmax

Epmin

Observation window p x Δt [min]

Prozentualer Flussfehler

Percentage flow error

-5

-10

-15 2 5 11 19

Percentage flow error

Prozentualer Flussfehler

-5

-10

-15 2 5 11 19

Note: Every syringe has certain tolerances

in start-up behaviour (depending on the syringe manufacturer, syringe plunger material, siliconisation of the cylinder etc.).

In order to keep the delay as short as possible, the syringe should be as small as possible and the plunger moved before the syringe is inserted in order to work through the rubber stopper’s breakloose force behaviour.

The device is equipped with start acceleration, which enables a quick infusion start after each syringe change.

50 ml Omnifix

Förderrate = 1 ml/h

Delivery rate = 1 ml/h

Epmax

Epmin

Observation window p x Δt [min]

Beobachtungsfenster p x ∆t [min]

50 ml Omnifix

Förderrate = 5 ml/h

Delivery rate = 5 ml/h

Epmax

Epmin

Observation window p x Δt [min]

Beobachtungsfenster p x

t [min]

Note: Always use the device with the

smallest possible syringe, provided the therapy permits this.

Page 42

Start-up and trumpet curves

This is particularly important if highly concentrated or life-sustaining drugs with short half-lives are to be infused at low infusion rates.

When infusing at low rates and with large syringes, there can be deviations from the pump‘s technical data, which can lead to delivery deviations, delayed startup behaviour and longer alarm times in the event of system occlusions (pressure alarms).

Recommendation

Syringe size [ml]

Recommended

50/60

30 20

1 1 0.5

minimum rate [ml/h]

Recommendation

Syringe size [ml] 10 5 3

Recommended

0.1

0.05

0.01

minimum rate [ml/h]

Note: The system accuracy is normally

±2% of the volume, measured using the trumpet curve test method according to IEC60601-2-24 at a rate of 1ml/h (at20°C ± 2°C) and using the recommended syringes.

Start-up curves

Measurement interval

Δt = 0.5min

Measurement duration T = 120 min

Flow Q

(ml/h)

Trumpet curves (Measured values for second hour in each case)

Measurement interval

Observation interval

Δt = 0.5min

p x Δt [min]

These graphs show the accuracy and uniformity of ow over time. Take into account:

The delivery behaviour and the delivery accuracy are fundamentally aected by the type of syringe used (disposable item).

Deviations from the pump technical data cannot be ruled out for competitors’ syringes.

Page 43

Start-up and trumpet curves

Zeit (h:mm:ss)

P5 P9P1

1:26:24

1:12:00

0:57:26

0:43:12

0:28:48

0:14:24

0:00:00

Druckstufe

15.3 Alarm times

The following graphs show the alarm times

15.3.1 Omnix® 50 ml

Time [hh:mm:ss]

Omnifix® 50 ml

of the B. Braun syringe shown according to pressure and syringe type.

Note: The alarm times for syringes from

other manufacturers may vary slightly.

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

is > 4 h.

Manufactured by Syringe type Article number

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

Pressure level = 1

0.1 bar max. alarm times

[mm:ss]

1 ml/h

5 ml/h

Pressure level

Pressure level = 9

1.2 bar max. alarm times

[mm:ss]

Page 44

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. Dierent media viscosities and temperatures may lead to deviations.

Parameter Value

Type of device Infusion syringe pump Product classication According to Directive 93/42 EEC:

IIb

According to EN 60601-1:

Protection class II

For TypeCF applied parts with debrillation protection

Moisture protection IP34

Power supply

100-240 V, 50-60 Hz, connection via power cable or compact

12 V DC 12V CP interface cable

10 VA typ.

plus

station

Internal battery

Battery life

Recharging time

Lithium-ion battery

Approx. 8h at 5ml/h with 50ml syringe

Approx. 4h

Power consumption <20 W

Current consumption/ charging current

Max. 0.6Ae (typ. <0.1Ae) at 100-240V, 50-60 Hz

Max. 1.5A (typ. <0.5 A) at 12VDC

Sta 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

sound pressure range

Nine avail able levels:

45dB(A) to 75dB(A)

Page 45

Technical data

Parameter Value

Interfaces

Operating conditions

Temperature

Relative humidity

Atmospheric pressure

Storage conditions

Temperature

Relative humidity

Atmospheric pressure

Weight Approx. 2.3kg

Cold connector for mains voltage

Accessory port for interface cable 12V CP and sta call

IrDA infrared for communication in the station and for service

+5 °C … +40°C (+41 °F … +104°F)

30% … 90% (without condensation)

0.54 … 1.06bar

-20 °C … +55°C (-4 °F … +131°F)

20% … 90% (without condensation)

0.5 … 1.06bar

Dimensions in mm (W x H x D)

Approx. 290 mm x 98 mm x 220 mm (including compact

plus

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 incorrect dose

Max. bolus volume after

In the event of an incorrect dose of max. 0.2ml due to pump malfunction, the pump will automatically switch o.

≤0.2ml

bolus reduction

Page 46

Technical data

Parameter Value

KVO rate

Rate: ≥ 10ml/h: KVO rate 3ml/h

Rate: < 10ml/h: KVO rate 1ml/h

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

1,000 history entries The oldest entries are overwritten if necessary.

100 events for system diagnosis The history is retained when the device is switched o 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]

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

[ml/h]

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.

Page 47

Electromagnetic compatibility

17 Electromagnetic

compatibility

Note: In order to meet with the following

compliance levels, only original accessories and replacement parts may be used. Otherwise, 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 following electromagnetic environment. The device users and customers should ensure that it is being operated in such an environment.

Page 48

Electromagnetic compatibility

17.1 Electromagnetic interference emissions

Interference emission measurements

HF emissions According to CISPR 11

Harmonic emissions according to IEC 61000-3-2

Voltage uctuation/icker emissions according to IEC61000-3-3

Compliance Electromagnetic environment

guidelines

Group 1 The device uses HF energy for its internal

functions only. Assuch, its HF emissions rate is very low and it is unlikely to interfere with nearby electronic equipment.

Class B

Not applicable

Conforms

The device is intended for use in all establishments (including residential areas and similar) directly connected to a public power grid that also supplies buildings used for residential purposes.

Page 49

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

EN 60601-1-2 EN 60601-2-24

Electrostatic discharge (ESD) according to IEC 60601-4-2

Electrical fast transient/ bursts according to IEC60601-4-4

Surges according to IEC 61000-4-5

Contact discharge EN 60601-1-2: ±6 kV

IEC 60601-2-24: ±8 kV

Air discharge

EN 60601-1-2: ±8 kV IEC 60601-2-24: ±15 k V

for power supply lines ±2 kV

For input and output lines ±1 kV

±1 kV outer conductor - outer conductor voltage

±2 kV voltage Outer conductor ground

Compliance level

±6 KV without interference ±8 KV outage with alarm permitted

±8KV without interference ±15KV outage with alarm permitted

±2 kV The supply voltage quality

±1 kV

±1 kV The supply voltage quality

±2 kV

Electromagnetic environment guidelines

Floors should be wood, concrete, orceramic tile. Ifthe oor covering is made of a synthetic material, relative air humidity needs to be at least 30%.

should be the same as that of a typical commercial or hospital environment.

Page 50

Electromagnetic compatibility

Immunity tests Test level

EN 60601-1-2 EN 60601-2-24

Voltage dips, brief supply voltage interruptions and uctuations according to IEC61000-4-11

< 5% UT ¹ for ½ periods (>95% dip)

40% UT ¹ for 5 periods (60% decline)

70 % UT ¹ for 25 periods (30 % decline)

<5% UT ¹ for 5 s (>95% dip)

Magnetic eld at

3 A/m 400 A/m Magnetic elds at the supply frequency (50/60 Hz) according to IEC61000-4-8

Conducted HF interference according to IEC61000-4-6

3 V

e

150 kHz to 80MHz

Outside ISM bands

10 V

e

Within ISM bands

Compliance level

Complies through the use of an internal energy source

10 V

e

In all bands

Electromagnetic environment guidelines

The supply voltage quality should be the same as that of a typical commercial or hospital environment.

supply frequency should correspond to those typically found in commercial and hospital environments.

Do not use portable and mobile radio communications equipment closer to the Perfusor® compact

plus

(including connection cables) than the recommended safe distance calculated using the appropriate equation for that frequency.

Recommended safety distance: d = 1.2 √P³

Page 51

Electromagnetic compatibility

Immunity tests Test level

EN 60601-1-2 EN 60601-2-24

Radiated HF interference according to IEC 61000-4-3

10 V/m 80MHz to

2.5 GHz

Compliance level

[E1] 10 V/m 80MHz to 6GHz und 500MHz to 3 GHz

Electromagnetic environment guidelines

The eld strength should be lower than 10V/m

d = 12/E1 √P ² 80MHz to 800MHz

d = 23/E1 √P ² 800MHz to 6 GHz

Field strengths from stationary RF transmitters 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 specications and as the recommended safe distance in metres (m).

Page 52

Electromagnetic compatibility

Note: The deviating test values derived

from IEC 60601-2-24 are labelled in the table. However, these test values allow one outage with an alarm while the test values according to DINEN 60601-1-2 do not allow any outages.

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 equipment causing interference if accidentally brought into the patient area. For this reason the additional factor 10/3 is used when calculating the recommended safe distances in these frequency ranges. Field strengths emitted from stationary transmitters (such as 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 transmitters. Ifthe measured eld strength in the area the Perfusor® compact used in exceeds compliance levels, monitor the Perfusor® compact that it is functioning properly. Ifabnormal performance is observed, additional measures may be necessary, e.g., changing the device’s location or facing it in a dierent direction.

base stations for

plus

is being

plus

to ensure

17.3 Recommended

safe distances

The device is designed for use in an electromagnetic environment in which HF disruptions are controlled. Customers or users of the device can help avoid electromagnetic interference by maintaining a minimum distance between portable or mobile HF telecommunications equipment (transmitters) and the device – depending on the communication equipment’s output power, asdescribed below.

Page 53

Electromagnetic compatibility

Transmitter rated power in W

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

maximum rated power is not specied in 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 specications.

Note: These guidelines may not be appli

cable in all cases. Electromagnetic propagation is aected by the absorptive and reective qualities of the surrounding structures, objects and people.

Safe distance according to transmitter frequency m

150 kHz to 80 MHz ¹

1.2√P

80 MHz to 800 MHz

1.2√P

the recommended safe distances in these frequency ranges.

800 MHz to 6 GHz ¹

2.3√P

Page 54

Instructions for use for accessories

18 Instructions for use for

accessories

18.1 Interface lead 12 V

CP (8718020)

Connect the device for charging the battery with vehicle socket

WARNING! Risk to the patient from

electric shock!

Do not use the device on patients ifthe emergency ambulance is connected to the vehicle charger.

Plug interface cable 12V CP into the accessory port on the side of the device.

Plug interface cable 12V CP into the vehicle socket.

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.

18.2 Sta call interface lead

CP (8718030)

Connect device to the sta call system

The sta call system must comply with the requirements of VDE 0834.

Observe country-specic regulations on sta calls.

Plug the STAFF CALL interface lead CP into the accessory port on the side of the device or service port on the compact

Connect the STAFF CALL interface lead to the sta call system.

Set the sta call operating mode using the service programme. Follow the sta call system procedure.

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

plus

station.

Page 55

Instructions for use for accessories

The device has two dierent sta call operating modes:

Switched off

Static without offalarm *)

Dyn. without oalarm *)

In “static without o alarm” mode, the sta call can be disabled by pressing the OK key.

Alarm

Operation

Alarm

Operation

operating alarm

1 sec.

Switched offSwitched on

Page 56

Ordering data

19 Ordering data

Art. no. Name

8717030 Perfusor® compact

19.1 Accessories

Recommended accessories for the Perfusor® compact

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

plus

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 lter; 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

Page 57

Ordering data

19.1. 2 Interface lead

Art. no. Name

8718020 Interface lead 12V CP 8718030 Interface lead sta 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 lter 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 lter needle 8728861F-06 Original Perfusor® syringe, 50ml, protected from light,

orange with lter needle 4617509F Omnix® 50ml 4617510F-06 Omnix® 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.

Page 58

Index

Abbreviations 7 Accessories 13, 54, 56 Administering bolus 28 Alarm levels 24 Alarms 12, 18, 34 Alarm status (display) 18 Alarm times 43

Battery operation 22, 37, 44 Battery operation and maintenance 37 Bolus rate 21, 24 Bolus Time 28 Bolus volume 28 Brightness (display) 20, 23

Changing the battery 38 Changing the syringe 32 Claws 14 Cleaning 37 Consumables 13 Control 12 Control elements 16

Date 21, 24 Decommissioning 38 Delivery accuracy 45 Delivery rate 19, 26, 31 Description of the device 14 Device alarms 34 Device options 20, 22 Device overview 14 Display brightness 20, 23 Display elements 16 Display screen 18 Disposal 39 Dose calculation 20, 30

Drive head 14 Drug database 19, 29

Electrical connection 13 Electromagnetic compatibility 47 Electromagnetic immunity 49 Electromagnetic interference emissions 48 Ending the infusion 32 Enteral nutrition 13 Enter time 19, 31 Enter volume 19, 31

First start-up 22 Fixing lever 14

Hard limits 29

Immunity (EMC) 49 Inserting the syringe 26 Intended use 10 Interface lead 12V CP 54, 57 Interface lead sta call CP 54, 57 Interfaces 15, 45 Interference emissions (EMC) 48

Keypad lock 25 Keys 16 KVO 21, 25

Language 21, 24 LED 16 Limits 29 Lock (keypad) 25 Loudness 12, 20, 23

Page 59

Main menu 19 Mains connection 22 Maintenance 37, 38 Manual bolus 28 Menu structure 19

Night mode 20, 23 Night schedule 21, 25

Operating alarms 18, 35 Operating conditions 45 Operation 26 Ordering data 56

Perfusor® lines 56 Plunger plate stop 14 Pre-alarms 18, 34 Pressure alarm limit 20, 23 Prime (infusion line) 33 Priming the infusion line 33 Protection class 44

Rate 19, 26, 31 Reminder alarm 36 Repair 38 Reset (therapy) 32 Resetting the therapy 32

Safe distance (EMC) 52 Safety check 39 Safety instructions 11 Safety standards 13 Service 39 Service settings 21, 24

Set-up 11, 22 Soft limits 30 Software 11 Stacking 11 Sta call 12, 44 Standby 27 Stand clamp 15, 22 Starting and stopping the infusion 27 Start-up 11, 22 Start-up curves 39 Station 22 Storage 11 Storage conditions 45 Switch o 33 Switch on 26 Symbols 5, 9 Symbols on the device’s display 9 Symbols on the product and packaging 8 Syringe bracket 14 Syringe fastening 14 Syringes 57

Technical data 44 Temperature 45 Time 21, 24 Training 11 Transport 11 Trumpet curves 39

Unlock (keypad) 25

Wall rail 22 Warnings 6

Page 60

Manufactured by: B. Braun Melsungen AG

34209 Melsungen Germany Tel +49(0) 56 61 71-0 www.bbraun.com www.space.bbraun.com

38932101 • Drawing no. I0002700001 2017-05-18 • Information as of: March 2017

Printed on 100% chlorine-free bleached pulp

Distributed by: B. Braun Melsungen AG

Hospital Care Division 34209 Melsungen Germany Tel +49 (0) 56 61 71-0 Fax: +49 (0) 56 61 71-20 44 www.bbraun.com

Braun Perfusor compact plus Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

1 About this document

1.1 Purpose

1.2 Signs, symbols and tags

1.3 Warnings

1.4 Abbreviations

2 Symbols

2.2 Symbols on the device‘s display

3 Intended use

4 Safety instructions

4.1 Safe handling

4.1.1 General

Software

Transport and storage

Set-up and start-up

4.1.5 Stacking

Control

4.1.8 Accessories and consumables

4.1.9 Enteral nutrition

4.2 Electrical connection

4.3 Safety standards

5 Description of the device

5.1 Device overview

5.2 Interfaces

5.3 Display and control elements

5.4 Display overview

5.5 Alarm status display

Menu structure / device functions

6.1 Main menu

Main menu > Drug

Main menu > Dose calculation

6.1.4 Main menu > Settings

6.1. 5 Settings > Service

7 Set-up and powering on

Operating the device on a stand

Setting display brightness

Setting the Audio Volume

8 Operation

8.1 Switching on the device

8.2 Inserting the syringe

8.3 Setting the infusion values

Entering the delivery rate

8.5 Activating standby

8.6 Administering bolus

Administering a manual bolus

Administering a bolus with preselected bolus volume/bolus duration

8.7 Using the drug database

8.7.1 Hard and soft limits

8.8 Calculating the dose

8.10 Resetting the therapy

8.11 Changing the syringe

8.12 Ending the infusion

8.14 Priming the infusion line

9 Alarms

9.1 Device alarms

9.2.1 Pre-alarms

9.2.2 Operating alarms

9.3 Reminder alarm

10 Cleaning and care

10.1 Cleaning

11 Decommissioning

Changing the battery

12 Maintenance and repair

13 Disposal

14 Safety check/service

15.3 Alarm times

Omnifix® 50 ml

16 Technical data

Electromagnetic compatibility

17.1 Electromagnetic interference emissions

17.2 Electromagnetic immunity

Instructions for use for accessories

19 Ordering data

19.1 Accessories

19.1.1 Original Perfusor® lines

19.1. 2 Interface lead