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Table of Contents

About this document

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

1.1

Purpose

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

1.2

Signs, symbols and tags

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

1.3

Warnings

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

1.4

Abbreviations

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

Symbols

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

2.1

Symbols on the product and packaging

.....

2.2

Symbols on the device’s display

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

Intended use

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

Safety instructions

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

4.1

Safe handling

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

4.1.1

General

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

4.1.2

Software

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

4.1.3

Transport and storage

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

4.1.4

Set-up and start-up

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

4.1.5

Stacking

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

4.1.6

Operation

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

4.1.7

Alarms and staff call

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

4.1.8

Accessories and consumables

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

4.1.9

Enteral nutrition

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

4.2

Electrical connection

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

4.3

Safety standards

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

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

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

6.1.1

Main menu > Rate, volume & time

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

6.1.2

Main menu > Drug

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

6.1.3

Main menu > Dose calculation

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

6.1.4

Main menu > Settings...

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

6.1.5

Settings > Service

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

Set-up and start-up

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

7.1

Setting up and connecting the device

.....

7.1.1

Attach/remove the compact

plus

pole clamp

....

7.1.2

Operating the device on a stand

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

7.1.3

Operating the device in the
compact

plus

station

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

7.1.4

Operating the device on a wall rail

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

7.1.5

Connecting the device to the
mains electricity

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

7.1.6

Operating the device on battery power

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

7.2

Powering on the device
for the first time

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

7.3

Configure device options

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

7.3.1

Turning night mode on/off

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

7.3.2

Setting display brightness

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

7.3.3

Setting the audio volume

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

7.3.4

Configuring the pressure alarm limit

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

7.3.5

Configuring service settings

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

7.4

Locking/unlocking the keypad

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

Operation

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

8.1

Switching on the device

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

8.2

Inserting the infusion line

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

8.3

Priming the infusion line

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

8.4

Use with Intrafix® SafeSet

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

8.5

Setting the infusion values

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

8.5.1

Entering the delivery rate

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

8.6

Starting and stopping the infusion

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

8.7

Activating standby

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

8.8

Administering a bolus

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

8.8.1

Administering a manual bolus

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

8.8.2

Administering a bolus with preselected
bolus volume/bolus duration

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

8.9

Using the drug database

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

8.9.1

Hard and soft limits

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

8.10

Calculating the dose

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

8.11

Entering a combination of delivery rate,
volume and time

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

8.12

Resetting the therapy

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

8.13

Changing the infusion line

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

8.14

Ending the infusion

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

8.15

Switching off the device

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

38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 3

15.10.2020 17:47:22

Содержание Infusomat compact plus P

Страница 1: ...rder 4900 lw 04 2020 Basis DE v3 Infusomat compactplus P Instructions for use EN Version 1 0 Valid for software 003A H M m v M m v M m v 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 1 15 10 202...

Страница 2: ...38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 2 15 10 2020 17 47 22...

Страница 3: ...Operating the device in the compactplus station 22 7 1 4 Operating the device on a wall rail 22 7 1 5 Connecting the device to the mains electricity 22 7 1 6 Operating the device on battery power 22 7...

Страница 4: ...42 16 3 Alarm times 43 16 3 1 Intrafix Primeline 43 17 Technical data 44 18 Electromagnetic compatibility 47 18 1 Electromagnetic interference emissions 48 18 2 Electromagnetic immunity 49 18 3 Recomm...

Страница 5: ...use avail able near the device Q Q Read and follow other applicable documents 1 2 Signs symbols and tags Symbol Meaning Q Q Prerequisite Q Q Handling step Follow the specified instructions Key Key Pre...

Страница 6: ...ple Non compliance could lead to minor injuries CAUTION Risk of damage or incorrect operation Non compliance could lead to material damage to the device or to incorrect operation 1 4 Abbreviations Abb...

Страница 7: ...sult instruction for use Refer to instruction manual Follow instruction for use Labeling of electric and electronic devices according to directive 2002 96 EC WEEE CE marking according to Directive 93...

Страница 8: ...f P1 to P9 pressure level set with current system pressure pointer Caution Pre alarm Caution Operating alarm Infusion is above the upper soft limit Infusion is below the lower soft limit Pre alarm tem...

Страница 9: ...mp is intended for use in adults children and neonates for the intermittent or con tinuous administration of parenteral and enteral solutions The intended medical therapies include predefined or calcu...

Страница 10: ...it and the air sensor in particular for contamination damage missing parts and functionality Q Q Pay attention to audible and visible alarms the lighting up of the two 4 Safety instructions Q Q Read t...

Страница 11: ...trosurgical devices magnetic resonance imaging units mobile telephones keep the device the recommended safe distance away from such equipment status LEDs and the display during the self test Q Q When...

Страница 12: ...e of untested or incompatible disposable items can affect the technical data PUR lines can t be used with the device 4 1 7 Alarms and staff call Q Q The volume of the device s acoustic alarms can be a...

Страница 13: ...ot been approved for use with device Position the power cable so that it does not present a trip hazard 4 3 Safety standards Q Q The Infusomat compactplus P complies with all safety standards for medi...

Страница 14: ...escription of the device 5 1 Device overview 1 2 3 4 5 No Name 1 Air sensor 2 Active safety clamp 3 Pressure sensor 4 Upstream sensor 5 Passive safety clamp 38932401_Infusomat_compactPlusP_EN_IFU_1020...

Страница 15: ...staff call ambulance 3 Mains connection socket for power cable In the event of a power cut the device switches to battery mode automatically 4 Infrared interface communication in station 5 Guide rails...

Страница 16: ...if enabled in Service Tool Red LED Technical alarm operating alarm 3 Arrow keys Q Q Scroll through menus Q Q Change settings Q Q Answer yes no questions Q Q Select scale values and change between dig...

Страница 17: ...is locked and unlocked by pressing and holding down the menu key 7 Menu key Call up main menu and lock unlock the device 8 Info key Call up therapy data from the current infusion 9 Bolus key Initiate...

Страница 18: ...lay overview 1 2 3 4 5 6 7 No Display Function 1 Moving arrows Delivery in progress stopped delivery is shown by two bars 2 Mains connection battery status 3 Pressure symbol manometer Indication of P1...

Страница 19: ...ug Concentra tions Select concentration Note All menu items except Drug are optional and are only requested if there are corresponding entries in the database 6 Menu structure device functions 6 1 Mai...

Страница 20: ...e g Q Q Language Q Q Date Q Q Time Q Q Bolus rate Q Q KVO Q Q Night schedule Q Q System info Q Q History 6 1 3 Main menu Dose calculation Menu Meaning Dose unit Select unit Q Q mg Q Q g Q Q ng Q Q IU...

Страница 21: ...time Bolus rate Enter default bolus rate KVO Switch KVO on off Night schedule Set night schedule Q Q On off Q Q Activate at Q Q Deactivate at System info Display system information Q Q Hardware versio...

Страница 22: ...d 7 Set up and start up 7 1 Setting up and connecting the device 7 1 1 Attach remove the compactplus pole clamp Note The compactplus pole clamp is fixed to the device Q Q The compactplus pole clamp sh...

Страница 23: ...the post occlusion bolus will be automatically reduced Q Q Select Pressure alarm and press OK to confirm Q Q Select alarm level and press OK to confirm Level 1 lowest level to Level 9 highest level Al...

Страница 24: ...d press OK to confirm Q Q Set the bolus rate and press OK to confirm Alarm level Pressure value 4 0 300 bar 225 mmHg 5 0 400 bar 300 mmHg 6 0 500 bar 375 mmHg 7 0 700 bar 525 mmHg 8 0 900 bar 675 mmHg...

Страница 25: ...firm Setting the night schedule Q Q Select Night schedule and press OK to confirm Q Q Select On Off and press OK to confirm Q Q Select On Off and press OK to confirm Q Q Select Activate and press OK t...

Страница 26: ...est Note Pay attention to audible and visible alarms the lighting up of the two status LEDs and the display during the self test First the green and the yellow LEDs light up and then the yellow LED ch...

Страница 27: ...osed is not monitored by the pump 8 3 Priming the infusion line Note The Prime infusion line function is started after an air alarm It enables the line to be primed by the pump without having to remov...

Страница 28: ...airtight filter membrane acts as a barrier and helps prevent air entering the line If the fluid level reaches the membrane the upstream alarm is triggered and the pump stops so that no air passes thro...

Страница 29: ...On Off key or Back key Q Q Press the Start Stop key The delivery is re started with the previously set values 8 6 Starting and stopping the infusion Q Q Values for the treatment set Q Q Press the Sta...

Страница 30: ...s calculated Q Q Press the Bolus key The bolus administration is started After the time has elapsed the bolus administration is ended and the infu sion continued 8 8 Administering a bolus There are th...

Страница 31: ...rect 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 a...

Страница 32: ...ty of the displayed values Q Q Start the infusion with the Start Stop key Soft limits Soft limits for rate dose bolus volume and bolus rate can also be stored in the database These can be exceeded wit...

Страница 33: ...s adjusted Q Q 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 Calculation using Weight Q Q Select W...

Страница 34: ...Q 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 re...

Страница 35: ...e display 9 Alarms 9 1 Device alarms If a device alarm is triggered the infusion is stopped immediately Q Q Press the On Off key to switch off the device Q Q Switch the device on again If there is ano...

Страница 36: ...placement Upstream pressure alarm The pressure on the container side is too low e g because the container is empty 9 2 2 Operating alarms In the event of an operating alarm the infusion is stopped An...

Страница 37: ...ing Pump door open Pump door was opened during delivery 9 3 Reminder alarm Reminder alarms are triggered in the follow ing cases Q Q An infusion line is inserted the pump is not delivering and no inpu...

Страница 38: ...ure Essigs ure Phenols o phenylphenol p Chlor m cresol 10 Cleaning and care Q Q Device is switched off Q Q Device is unplugged from the mains Q Q Device accessories are disconnected 10 1 Cleaning Disi...

Страница 39: ...y decreases to around half of the original nominal value Q Q When the device is in mains operation mode the battery discharges slowly and may be fully exhausted even if the device is not in operation...

Страница 40: ...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 Q Q Optimal ba...

Страница 41: ...t the prescription is in line with the start up trumpet curve and the set flow rate 15 Warranty B Braun provides 24 months warranty as from the date of delivery for every Infusomat compactplus P This...

Страница 42: ...ation window p x t min Observation window p x t min Percentage flow error Percentage flow error 16 2 Typical start up and trumpet curves 0 12 5 37 5 50 0 25 0 0 30 1 00 1 30 2 00 Fluss Q t ml h 2 5 11...

Страница 43: ...into account Q Q The delivery behaviour and the delivery accuracy are fundamentally affected by the disposable item used Q Q Variations in consumable and consum able handling e g stretching may affec...

Страница 44: ...splashes from all directions Power supply Q Q 100 240 V AC 50 60 Hz connection via power cable or compactplus station Q Q 12 V DC 12 V CP interface cable Internal battery Q Q Battery life Q Q Recharg...

Страница 45: ...ght Approx 2 0 kg Dimensions in mm W x H x D Approx 229 mm x 98 mm x 225 mm including pole clamp compactplus Safety check Every 2 years Volume preselection 0 1 ml 9 999 ml in increments of 0 01 ml Tim...

Страница 46: ...tory is retained when the device is switched off or the battery removed Note The preset bolus rate 800 ml h can be changed via the service menu or once via the combination of bolus volume and bolus ti...

Страница 47: ...NING Functional reliability is only guaranteed if accessories that have been approved and there fore recommended by B Braun Melsungen AG are used Accessories are listed in section 20 1 WARNING If the...

Страница 48: ...ssions according to IEC 61000 3 3 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 bui...

Страница 49: ...age with alarm permitted Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the rela tive humidity should be at least 30 Air discharge IEC 60601 1 2 8 kV IEC...

Страница 50: ...C 61000 4 8 3 A m 400 A m Magnetic fields at the supply frequency should correspond to those typi cally found in commercial and hospital environments Conducted RF interference according to IEC 61000 4...

Страница 51: ...z to 800 MHz d 2 3 x P 2 800 MHz to 6 GHz Field strengths from stationary RF transmit ters should be below the compliance level for all frequencies based on an on site test Interference is possible in...

Страница 52: ...ances in these frequency ranges Field strengths emitted from stationary transmitters such as base stations for cordless telephones and land mobile radio devices amateur radio stations or AM and FM rad...

Страница 53: ...The higher value applies at 80 MHz and 800 MHz Note For transmitters whose rated power is not specified in the table above the distance can be determined using the equation for the relevant column P...

Страница 54: ...lug the STAFF CALL interface lead CP into the accessory port on the side of the device or service port on the Station compactplus Q Q Connect the STAFF CALL interface lead to the staff call system Q Q...

Страница 55: ...nical data Mode Status red LED Status Changeover Contact wire color white green Status Changeover Contact wire color white brown Operating off closed opened Alarm on opened closed Accessory Parameter...

Страница 56: ...Description 8717110 Power cord EU Power cord Typ E F 8717111 Power cord GB Power cord Typ G 8717112 Power cord US Power cord NEMA 5 15p hospital grade 8717113 Power cord AU Power cord Typ I 8717114 P...

Страница 57: ...heck valve 180cm 4063005 Intrafix SafeSet with injection port 180cm Primeline 4062182 Intrafix Primeline with injection port 180cm 4062957E Intrafix Primeline 150cm 4063287 Intrafix Primeline with bac...

Страница 58: ...y 16 23 Display Notifications 37 Display screen 18 Disposal 40 Drug database 31 E Electrical connection 13 Electromagnetic compatibility 47 Electromagnetic immunity 49 Electromagnetic interference emi...

Страница 59: ...ice settings 21 Setting the infusion values 28 Set up 22 Set up and start up 10 Short stand SP 4 54 Software 10 Stacking 11 Standby 29 Starting and stopping the infusion 29 Start up 22 Start up and tr...

Страница 60: ...d cellulose Sales B Braun Melsungen AG Hospital Care division 34209 Melsungen Germany Tel 49 0 56 6171 0 Fax 49 0 56 6171 20 44 www bbraun com Manufacturer B Braun Melsungen AG 34209 Melsungen Germany...

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