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Ordering data

20.3

Infusomat® compact

plus

P lines

Art. no.

Name

Length

SafeSet
4063000

Intrafix SafeSet

180 cm

4063001

Intrafix SafeSet with back check valve

180 cm

4063005

Intrafix SafeSet with injection port

180 cm

Primeline
4062182

Intrafix Primeline with injection port

180 cm

4062957E Intrafix Primeline

150 cm

4063287

Intrafix Primeline with back check valve

180 cm

4062981L

Intrafix Primeline

180 cm

Hinweis DTP 06-20

Kapitel 20.3:

Artikelnummer für

Intrafix SafeSet
geändert nach 4063000

War m.E. nicht korrekt

als 063000.
(Korrektur stammte aus
ILE vom 06.02.2020.)

--> bitte bestägigen.

So auch in DE geändert.

38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 57

15.10.2020 17:47:33

Содержание 8717050

Страница 1: ...order 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 2020 17 47 22 ...

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 2 Powering on the device 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 Configur...

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 Recommended safe distances between portable and mobile RF telecommunications equipment and the Infusomat compactplus 53 19 Instructions for use for accessories 54 19 1 Interface lead 12 V CP 8718020 54 19 ...

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 Press the specified keys one after the other Warning symbol introduces a warning Note Information to clarify or optimise work processes Bold Name of a navigational or an input element 38932401_Infusomat...

Страница 6: ...ople 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 Abbreviation Meaning EMC Electromagnetic compatibility KVO Keep vein open SC Safety check LED Light emitting diode HF High frequency ESD Electrostatic discharge 38932401_Infusomat_compactPlusP_EN_IFU_10...

Страница 7: ...nsult 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 42 EEC ECE test mark Alternating current Protective insulation protection class II device Defibrillation proof type CF applied part see section 19 1 Accessories Catalog number Batch number 38932401_I...

Страница 8: ...of 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 temporarily muted Active communication via Infrared New Software or Drug Library update available 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 8 15 10 2020 17 47 24 ...

Страница 9: ...ump 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 calculated infusion profiles These are used for the delivery of medi cations and fluids indicated for infusion via intravenous intra arterial irrigation subcutaneous epidural enteral route of administrati...

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 the safety instructions before using the device and observe them 4 1 Safe handling 4 1 1 General Q Q Make sure that the introductory training on the device is given by a B Braun sales representative o...

Страница 11: ...ctrosurgical 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 fixing the device to a box rail do not fix the device near the rail bracket Q Q Fully charge the battery before the first use without an external power supply 4 1 5 Stacking Q Q Stack a maximum of th...

Страница 12: ...se 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 adjusted for the envi ronmental conditions This ensures that the alarms are clearly audible Q Q Always monitor the pump alarms The use of the accessory cable or staff call does not adequately replace ...

Страница 13: ...not 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 medical electrical devices in accordance with IEC 60601 1 2005 IEC 60601 1 2005 AMD1 2012 IEC 60601 1 6 2010 IEC 60601 1 6 2010 AMD1 2013 IEC 60601 1 8 2006 IEC 60601 1 8 2006 AMD1 2012 IEC 60601 1 12 20...

Страница 14: ...Description 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_v5 indd 14 15 10 2020 17 47 25 ...

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 for connecting pumps 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 15 15 10 2020 17 47 25 ...

Страница 16: ...y 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 digits when inputting values Q Q Open a function while the infusion is ongoing or suspended 4 OK key Q Q Select confirm function Q Q Confirm value settings input alarms 38932401_Infusomat_compactPlusP_E...

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 bolus administration 10 Start Stop key Start stop the infusion 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 17 15 10 2020 17 47 26 ...

Страница 18: ...play 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 to P9 pressure level set with current system pressure pointer Note Pressure detector is also active when the device is stopped or in standby mode 4 Set delivery rate with drug administration unit 5 ...

Страница 19: ...rug 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 Main menu Menu Meaning Rate volume time Enter change infusion rate or calculate rate by entering the volume limit and infusion duration Drug Select the drug for the intended use Dose calculation Calcula...

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 μg Q Q ng Q Q IU Q Q mEq Q Q mmol Active substance quantity Set the concentration by entering the quantity of active substance and volume Volume Calculate using Weight Q Q Enter the patient s weight Body surface area...

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 version Q Q Software version Q Q Name of the drug file Q Q Time of next safety check Q Q Station name History Displays a list of changes to the infusion settings 38932401_Infusomat_compactPlusP_EN_IFU_1020...

Страница 22: ...ed 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 should only be removed or re attached by a service technician 7 1 2 Operating the device on a stand Q Q Press the lever on the compactplus pole clamp Turn the compactplus pole clamp to the desired posi...

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 Alarm level Pressure value 1 0 067 bar 50 mmHg 2 0 133 bar 100 mmHg 3 0 200 bar 150 mmHg 7 3 1 Turning night mode on off In night mode the display brightness is reduced Q Q Select Night mode and press ...

Страница 24: ...nd 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 9 1 000 bar 750 mmHg Note Occlusion must be resolved before the infusion is re started Otherwise it will affect the measurement accuracy The set pressure level is shown with a P for pressure and a n...

Страница 25: ...nfirm 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 to confirm Q Q Enter the time and press OK to confirm Q Q Select Deactivate and press OK to confirm Q Q Enter the time and press OK to confirm 7 4 Locking unlocking the keypad Locking the keypad prote...

Страница 26: ...test 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 changes colour to red Note The yellow LED only lights up if the function has been enabled in the Service Tool Note Alternatively the device can be switched on by opening the door 8 2 Inserting the infu...

Страница 27: ...losed 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 remove the line The line must be discon nected from the patient for this purpose CAUTION Ensure that the line guide is straight and avoid sagging bending otherwise the line may be damaged and could cause ...

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 through the AirStop filter For this reason no addi tional priming is required when quickly changing to the next container In the case of an upstream alarm the upstream sensor detects a low pressure in th...

Страница 29: ...e 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 Start Stop key to start the infusion The moving arrows in the display and the green LEDs show that the delivery is taking place Note The infusion rate set can be changed during an ongoing infusion by pr...

Страница 30: ...is 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 three different options for bolus administration Q Q Manual bolus Q Q Bolus with preselection of the bolus volume Q Q Bolus with preselection of the bolus volume and the bolus duration Note If the bolu...

Страница 31: ...rrect 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 Q Q Pump has just been switch...

Страница 32: ...ity 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 with no restriction 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 Infu...

Страница 33: ...is 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 Weight and press OK to confirm Q Q Enter weight and press OK to confirm Q Q Select dose unit and press OK to confirm Q Q Enter dose The rate is automatically calculated Note Pressing the OK key brings...

Страница 34: ...Q 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 remaining volume is adjusted 8 12 Resetting the therapy The Reset therapy function is used to delete all currently set therapy data A new therapy can be started Additionally the volume already infused ...

Страница 35: ...he 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 another technical alarm Q Q Disconnect the patient Q Q Remove the disposable article Q Q Switch off the device and send it to the technical service 9 2 Pre alarms and operating alarms WARNING Setting al...

Страница 36: ...eplacement 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 acoustic signal sounds the red LED flashes and a staff call is activated Note If an operating alarm is not acknowl edged within two minutes another acoustic signal sounds Display notification Meaning...

Страница 37: ...ning 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 input has been made on the device for two minutes Q Q A value input was started but not completed and confirmed within 20 seconds Q Q After the standby time has elapsed A staff call is activated and the ...

Страница 38: ...äure Essigsäure 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 Disinfection Cleaning and disinfection can be carried out by qualified medical professionals or by qualified and trained cleaning personnel CAUTION Before disinfecting the pump always disconnect the pump...

Страница 39: ...ty 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 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 Group Active Substance...

Страница 40: ...e 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 battery life will then only be achieved if the pump is in continu ous operation at room temperature in charged state The battery display on the pump is an approximate value based on the current deliver...

Страница 41: ...at 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 covers repair or replacement of parts damaged as a result of design manufacturing errors or material defects Modifications or repairs to the unit under taken by the user operator or by third par ties...

Страница 42: ...vation window p x Δt min Observation window p x Δt 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 19 Beobachtungsfenster p x t min Prozentualer Flussfehler 31 Zeit hh mm 15 7 5 7 5 0 2 5 11 19 Beobachtungsfenster p x t min Prozentualer Flussfehler 31 15 Epmax Epmin 0 30 1 00 1 30 2 00 Zeit hh ...

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 affect accuracy Q Q A container placed below the pump may result in delivery deviations Note The system accuracy is normally 5 of the volume measured using the trumpet curve test method according to IEC 60...

Страница 44: ...t 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 Recharging time Lithium ion battery Q Q Approx 8 h at 25 ml h 2 5 h at 1000 ml h Q Q Approx 3 h Power consumption 10 VA typ 40 VA max Under normal conditions charged battery room temperature 25 ml h 3 5 W C...

Страница 45: ...ight 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 Time preselection 00 01 h 99 59 h Delivery accuracy typ 5 according to IEC 60601 2 24 Note valid for 50 cm water column Occlusion alarm pressure 9 levels up to 1 bar Alarm in the case of incorrect dose ...

Страница 46: ...story 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 time Delivery accuracy during bolus administration is typically 5 The accuracy can deviate when administering small bolus volumes Essential performance characteristics for infusion pumps Q Q Infusion o...

Страница 47: ...RNING 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 equipment is oper ated in the vicinity of other equip ment which may cause high levels of interference e g HF surgical equip ment nuclear spin tomography units mobile telephones etc this equip ment m...

Страница 48: ...issions 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 build ings used for residential purposes Harmonic emissions according to IEC 61000 3 2 Not applicable Note 1 The limits for interference emissions are measured with individual components as well as with...

Страница 49: ...tage 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 60601 2 24 15 kV 8KV without interference 15KV outage with alarm permitted Electrical fast transient bursts according to IEC 61000 4 4 for power supply lines 2 kV 2 kV Mains power quality should be t...

Страница 50: ...EC 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 6 IEC 60601 1 2 150 kHz to 80 MHz 3 VRMS outside and 10 VRMS in ISM frequency bands IEC 60601 2 24 150 kHz to 80 MHz 10 VRMS 10 VRMS 150 kHz to 80 Mhz in all frequency bands Do not use portable radi...

Страница 51: ...Hz 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 the vicinity of equipment that has the following symbol 2 With P as the maximum rated power of the transmitter in watts W according to the trans mitter manufacturer specifications and d as the recom...

Страница 52: ...tances in these frequency ranges Field strengths emitted from stationary transmitters such as base stations for cordless telephones and land mobile radio devices amateur radio stations or AM and FM radio and television broadcasts theoretically cannot be predicted exactly Consider conducting a study of the site to determine electromagnetic environmental conditions as regards stationary transmit ter...

Страница 53: ...e 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 is the transmitter s rated power in W according the manufac turer s specifications Note A factor of 10 3 is used to calculate the recommended safe distance of trans mitters in the frequency range bet...

Страница 54: ...Plug 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 Set the staff call operating mode using the service programme Follow the staff call system procedure Q Q Check the staff call before each use of the device 19 3 Station compactplus 8717141 Station f...

Страница 55: ...hnical 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 Value Interface lead 12 V CP 8718020 Dimensions in mm W x H x D Cable length in mm Approx 75 mm x 43 mm x 15 mm Approx 2568 mm Interface lead staff call CP 8718030 Dimensions in mm W x H x D Cable le...

Страница 56: ...e 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 Power cord CH Power cord Typ J 8717115 Power cord ZA IN Power cord Typ M 8717117 Power cord CN Power cord Typ I Var 3 8717118 Power cord DK Power cord Typ K 8717121 Power cord AR Power cord Typ I Var ...

Страница 57: ...check 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 back check valve 180cm 4062981L Intrafix Primeline 180cm H K A I g W a I S 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 57 15 10 2020 17 47 33 ...

Страница 58: ...ay 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 emissions 48 Ending the infusion 34 Enteral nutrition 13 Enter time 19 Enter volume 19 G General 10 I Immunity EMC 49 Inserting the infusion line 26 Intended use 9 Interface lead 12 V CP 54 56 Interface...

Страница 59: ...vice 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 trumpet curves 41 Station 54 Switching off 34 Switching on 26 Symbols 5 7 Symbols on the device s display 8 Symbols on the product and packaging 7 T Tags 5 Technical data 44 55 Transport and storage 10...

Страница 60: ...ed 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 Tel 49 0 56 6171 0 www bbraun com 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5 indd 60 15 10 2020 17 47 33 ...

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