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Содержание Infusomat compact plus

Страница 1: ...ce0123 Infusomat compactplus Instructions for use Version 1 0 English Valid for software 003A ...

Страница 2: ......

Страница 3: ...plus pole clamp 21 7 1 2 Operating the device on a stand 21 7 1 3 Operating the device in the compactplus station 21 7 1 4 Operating the device on a wall rail 21 7 1 5 Connecting the device to the mains electricity 21 7 1 6 Operating the device on battery power 21 7 2 Powering on the device for the first time 21 7 3 Configure device options 21 7 3 1 Turning night mode on off 22 7 3 2 Setting displ...

Страница 4: ... and trumpet curves 40 15 1 Significance in clinical practice 40 15 2 Typical start up and trumpet curves 41 15 3 Alarm times 42 15 3 1 Infusomat Plus Line 42 16 Technical data 43 17 Electromagnetic compatibility 46 17 1 Electromagnetic interference emissions 47 17 2 Electromagnetic immunity 48 17 3 Recommended safe distances 51 18 Instructions for use for accessories 53 18 1 Interface lead 12 V C...

Страница 5: ...evice Q Q Keep these instructions for 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 o...

Страница 6: ...erious injuries CAUTION Danger for people 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 ...

Страница 7: ...ing Symbol Meaning Caution Consult 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 n...

Страница 8: ...stopped Mains connection battery status Pressure symbol manometer Indication 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 ...

Страница 9: ...in combination with specific infusion lines and accessories The pump is intended for use in adults children and newborns for the intermittent or con tinuous 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 adm...

Страница 10: ...afely locked in You will hear an audible click sound when the device is locked in 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 or another authorised person Q Q If the device is dropped or subjected to external force...

Страница 11: ...ms Q Q Hydrophobic filters can further reduce the infusion of microbubbles 4 1 6 Operation Q Q Stand in front of the device to operate it This ensures that you are able to reach all control elements and that the display is clearly visible Q Q Establish a connection to the patient only after the infusion line has been properly inserted and primed Discon nect it from the patient when chang ing infus...

Страница 12: ...t or NRFit feed systems and use only compatible combinations of devices accessories wear parts and disposable items Q Q Connected electrical components must comply with IEC EN specifications e g IEC DIN EN 60950 for data pro cessing equipment Anyone who con nects additional devices is considered a system configurer and is therefore responsible for compliance with sys tem standard IEC DIN EN 60601 ...

Страница 13: ... the device 5 Description of the device 5 1 Device overview No Name 1 Air Sensor 2 Attachment for safety clamp with push button 3 Downstream pressure sensor 4 Upstream pressure sensor 5 Anti freeflow mechanism 1 2 4 5 3 ...

Страница 14: ...ame 1 Pole clamp 2 Accessory port e g staff call ambulance 3 Mains connection socket for power cable In the event of a power cut the device switches to battery mode automatically 4 Infrared interface communication in station 5 Guide rails for connecting pumps ...

Страница 15: ...lay Green LED Delivery 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 ...

Страница 16: ...level 6 Lock unlock symbol The keypad is locked and unlocked by pressing and holding down the menu key 7 Menu key Call up main menu and lock unlock the device 8 Info key Call up therapy data from the current infusion 9 Bolus key Initiate bolus administration 10 Start Stop key Start stop the infusion ...

Страница 17: ...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 Volume already adminis...

Страница 18: ... Select drug categories Drugs Select drug 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...

Страница 19: ...vice Configure additional settings 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 Infusion 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 Ente...

Страница 20: ...ate in DD MM YYYY format Time Set 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 Infusion history Displays a list of changes to the infusion settings ...

Страница 21: ...confirm The Settings screen is displayed 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 comp...

Страница 22: ... Note In the event of a pressure alarm 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 re...

Страница 23: ...the bolus rate Q Q Select Bolus rate and 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 ...

Страница 24: ...m Q Q Select On Off and press OK to confirm 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 unlocki...

Страница 25: ...up of the two status LEDs and the display during the self test Note Alternatively the device can be switched on by opening the door 8 2 Inserting the infusion line Q Q Device switched on Q Q Open the pump door by pressing the door lever To do this grip the door lever from behind and pull it forward CAUTION Free flow Q Q Make sure that the roller clamp is closed before inserting the line Q Q Never ...

Страница 26: ...creen and open the roller clamp Q Q The pump will perform a calibration of the tube Note Only when the pump is switched on the door is completely closed and the dis posable item is correctly inserted will the pump have control over the disposable item and thus protect against free flow 8 3 Priming the infusion line Manually prime and insert the line Alter natively the line can also be primed by th...

Страница 27: ...ng the infusion values Q Q Infusion line inserted and selected Note Depending on the last therapy the pump starts either when the delivery rate is entered or when a drug is selected 8 4 1 Entering the delivery rate Q Q Enter the delivery rate using the arrow keys Q Q Start the infusion with the Start Stop key or Q Q Press OK to confirm the rate The Overview screen is displayed Q Q Select Vol Time ...

Страница 28: ...d hold it down 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 Q Q Release the Bolus key The bolus administration is ended and the infusion continued 8 6 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 ...

Страница 29: ...cessary select concentration and press OK to confirm Q Q Read the information in the Drug screen and press OK to confirm Q Q Enter the delivery rate Note Manual bolus administration is limited to a maximum of 10 s The bolus administration is automatically stopped but it can be continued by pressing the Bolus key again Note An acoustic signal sounds for every 1ml of bolus volume delivered 8 7 2 Adm...

Страница 30: ...Q Q Confirm the delivery rate by pressing OK The Overview screen is displayed Q Q Select Vol Time and press OK to confirm Q Q Enter the volume or time limit and press OK to confirm Any values still missing are automati cally calculated and displayed Note In addition to the volume and time limit the infusion rate can also be adjusted in the Overview screen Q Q Start the infusion with the Start Stop...

Страница 31: ...the infusion with the Start Stop key 8 9 Calculating the dose The Dose calculation function is used to calculate the delivery rate in ml h based on the dose parameters entered Q Q Infusion line inserted and selected Q Q Press the Menu key The main menu is displayed Q Q Select Dose calculation and press OK to confirm Q Q Select active substance unit and press OK to confirm Q Q Enter active substanc...

Страница 32: ...n entered the rate or dose rate is adjusted If the rate and volume have been entered the remaining volume is adjusted Calculation using Body surface area Q Q Select Body surface area and press OK to confirm Q Q Enter weight and press OK to confirm Q Q Enter the patient s height and then press OK to confirm Q Q Select dose unit and press OK to confirm Q Q Enter dose The rate is automatically calcul...

Страница 33: ...t therapy and press OK to confirm Q Q Press the up arrow key to reset the therapy Note the infused volume inf vol is not reset 8 12 Changing the infusion line Q Q Press the Start Stop key to stop the infusion The green LED turns off Q Q Disconnect the line from the patient and close the roller clamp Q Q Open the pump door by pulling the door lever Grip the door lever from behind and pull it forwar...

Страница 34: ... 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 alarm thresholds incorrectly may endanger the patient Q Q En...

Страница 35: ...the roller clamp and perform a line replacement 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 signa...

Страница 36: ...ture Display notification Meaning 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 sta...

Страница 37: ...lowly 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 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 Clean...

Страница 38: ... display on the pump is an approximate value based on the current delivery rate If the battery is old the battery display may differ from the actual achievable operating time CAUTION Risk of injury from the battery exploding or leaking Q Q Do not open or burn the battery 10 2 2 Changing the battery Q Q The battery should only be changed by a service technician ...

Страница 39: ...Remove accessory parts and dispose of according to the instructions Q Q Switch off the device and disconnect from the mains Q Q Prepare the device for storage or dis posal Comply with the storage conditions Follow the notes on disposal 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 ...

Страница 40: ... trumpet curve makes it easier for the treating doctor to decide if the pump is sufficiently precise for the administration of the desired drug Q Q Reconcile drugs with short half lives in particular with the delivery accu racy in this period on the trumpet curve The physiological effect of the drug can be affected by the flow and the disposable article Q Q Ensure that the prescription is in line ...

Страница 41: ...te 25ml h Delivery rate 100ml h Observation window p x Δt min Observation window p x Δt min Percentage flow error Percentage flow error 15 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 Epm...

Страница 42: ...h Zeit hh mm ss logarithmisch Infusomat Plus Line PVC P1 67 mBar P9 1000 mBar Druckstufe Time h mm ss Pressure level 0 1 ml h 1 ml h 25 ml h P1 67mBar P9 1000mBar These graphs show the accuracy and uniformity of flow over time Take into account Q Q The delivery behaviour and the delivery accuracy are fundamentally affected by the disposable item used Note The system accuracy is normally 5 of the v...

Страница 43: ... penetration by solid foreign bodies with a diameter of more than 2 5 mm Q Q Protection against 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 6 h at 25 ml h Q Q Approx 3 h Power consumption 20 W Current cons...

Страница 44: ... 0 5 1 06 bar Weight Approx 1 9 kg Dimensions in mm W x H x D Approx 229 mm x 98 mm x 220 mm including 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 5 according to IEC EN 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 d...

Страница 45: ...is The history is retained when the device is switched off or the battery removed Note For more information see the separate History Viewer documentation 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 bolu...

Страница 46: ...nvolving 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 environm...

Страница 47: ...uch its HF emissions rate is very low and it is unlikely to interfere with nearby electronic equipment HF emissions as per CISPR 11 Class B 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 Harmonic emissions as per IEC 61000 3 2 Not applicable Voltage flu...

Страница 48: ...Floors should be wood con crete or ceramic tile If the floor covering is made of a synthetic material relative air humidity needs to be at least 30 Air discharge EN 60601 1 2 8 kV IEC 60601 2 24 15 kV 8 kV without interference 15 kV outage with alarm permit ted Electrical fast transient bursts according to IEC 60601 4 4 for power supply lines 2 kV 2 kV The supply voltage quality should be the same...

Страница 49: ...for 25 periods 30 decline 5 UT for 5 s 95 dip Magnetic field at supply frequency 50 60 Hz according to IEC 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 HF interference according to IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz Outside ISM bands 10 Vrms In all bands Do not use portable and mobi...

Страница 50: ...12 E1 P 80 MHz to 800 MHz d 23 E1 P 800 MHz to 6 GHz Field strengths from station ary 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 UT is the AC mains voltage prior to test level application With P as the maximum rated power of the transmitter in watts W according...

Страница 51: ...r radio stations or AM and FM radio and television broadcasts theoretically cannot be predicted exactly Consider conducting a study of the site to determine electromagnetic environmental conditions as regards stationary transmit ters If the measured field strength in the area the Infusomat compactplus is being used in exceeds compliance levels moni tor the Infusomat compactplus to ensure that it i...

Страница 52: ...levels for ISM frequency bands between 150 kHz and 80 MHz and in the 80 MHz to 6 GHz frequency range are designed to minimise the likelihood of mobile portable communications equip ment causing interference if accidentally brought into the patient area There fore the additional factor 10 3 has been included in the formula and used when calculating the recommended safe dis tances in these frequency...

Страница 53: ... 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 Interface lead staff call CP 8718030 Connect device to the staff call system The staff call system must comply with the requirements of VDE 0834 Q Q Observe country specific regulations on staff calls Q Q Plug the STAFF CALL interface lead CP into the...

Страница 54: ...larm 1 sec In static without off alarm mode the staff call can be disabled by pressing the OK key 18 3 Short infusion stand 8713135 Use the short infusion stand to attach an infusion container to the pump Q Q Caution Note that the pump con nected to the short infusion stand can only be used on a flat surface and must not be carried by the handle Q Q Only use infusion containers with max 1000 ml wi...

Страница 55: ...s Line SafeSet Standard PUR 240cm PUR PVC free DEHP free 240cm 150cm 17 8ml 8700240 Infusomatplus Line SafeSet Standard PVC 300cm needle free Y Port PVC DEHP free 300cm 200cm 22 2ml 8700250 Infusomatplus Line SafeSet Standard PUR 300cm needle free Y Port PUR PVC free DEHP free 300cm 200cm 22 9ml Basic 8700310 Infusomat plus Line Standard PVC 240cm PVC DEHP free 240cm 150cm 17 3ml 8700320 Infusomat...

Страница 56: ...18 9ml Oncology 8700300 Infusomatplus Line SafeSet type Oncology 0 2 Filter PUR 240cm PUR PVC free DEHP free 240cm 150cm 20 3ml Flushing Set 8700280 Infusomatplus Line SafeSet FlushingSet PUR 300cm PUR PVC free DEHP free 300cm 200cm 19 0ml Enteral ENFit 8700370 Infusomatplus Line type Enteral Nutrition Mulitspike ENFit PUR PVC free DEHP free 330cm 220cm 28 0ml 8700400 Infusomatplus Line type Enter...

Страница 57: ...57 Ordering data ordering codes 19 1 2 Interface lead Art no Name 8718020 Interface lead 12 V CP 8718030 Interface lead staff call CP 19 1 3 Short infusion stand Art no Name 8713135 Short infusion stand ...

Страница 58: ...te 18 27 Description 13 Device overview 13 Display 15 22 Display screen 17 Disposal 39 Drug database 29 E Electrical connection 12 Electromagnetic compatibility 46 Ending the infusion 33 Enteral nutrition 12 Enter time 18 Enter volume 18 G General 10 I Inserting the infusion line 25 Intended use 9 Interface lead 57 Interface lead 12 V CP 53 Interface lead staff call CP 53 Interfaces 14 K Keys 15 L...

Страница 59: ...7 Set up 21 Set up and start up 10 Short infusion stand 57 Software 10 Stacking 10 Standby 28 Starting and stopping the infusion 27 Start up 21 Start up and trumpet curves 40 Switching off 33 Symbols 5 7 Symbols on the device s display 8 Symbols on the product and packaging 7 T Tags 5 Technical data 43 Transfusion 12 Transport and storage 10 W Wall rail 21 Warnings 6 ...

Страница 60: ...8 Printed on 100 chlorine free bleached 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 ...

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