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Instructions for use
Version 1.0 English
Valid for software 002A

Perfusor

®

compact

plus

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Содержание Perfusor compact plus

Страница 1: ...Instructions for use Version 1 0 English Valid for software 002A Perfusor compactplus...

Страница 2: ......

Страница 3: ...1 1 Attach remove the compactplus stand clamp 22 7 1 2 Operating the device on a stand 22 7 1 3 Operating the device in the compactplus station 22 7 1 4 Operating the device on a wall rail 22 7 1 5 Co...

Страница 4: ...posal 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...

Страница 5: ...r use before using this device Q Q Keep these instructions for use available near the device Q Q Read and follow other applicable documents 1 2 Signs symbols and tags Symbol Meaning Key Key Press the...

Страница 6: ...ath or serious injuries WARNING Danger for people Non compliance could lead to death or serious injuries CAUTION Danger for people Non compliance could lead to minor injuries CAUTION Risk of damage or...

Страница 7: ...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...

Страница 8: ...ng 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 Defibrillation proof type CF applied part...

Страница 9: ...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 Infus...

Страница 10: ...cated for the infusion therapy These include but are not limited to anaes thetics sedatives analgesics catechola mines etc blood or blood components solutions for total parenteral or enteral nutrition...

Страница 11: ...eli copters Q Q When stacking ensure that the device is correctly and safely locked in You will hear an audible click sound when the device is locked in 4 Safety instructions Q Q Read the safety instr...

Страница 12: ...vice 4 1 6 Control 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 Only connect the patient once...

Страница 13: ...r local infection control policy Q Q Only use pressure tested disposable items min 2 bar 1 500 mmHg Q Q Only use the device with accessories and consumables that have been approved for use with the de...

Страница 14: ...ion of the device 5 Description of the device 5 1 Device overview 1 2 4 5 6 3 No Name 1 Syringe holder 2 Syringe wings bracket 3 Syringe plate sensor 4 Claws 5 Drive head with emergency lock key 6 Rel...

Страница 15: ...Stand 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 comm...

Страница 16: ...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 w...

Страница 17: ...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...

Страница 18: ...o 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...

Страница 19: ...gories Select drug categories Drugs Select drug Concen trations Select concentration Note All menu items except Drug are optional and are only requested if there are corresponding entries in the datab...

Страница 20: ...Service 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 Function Dose...

Страница 21: ...ate Set date 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 Dis...

Страница 22: ...played Q Q Select Settings and press OK to confirm The Settings screen is displayed 7 Set up and powering on 7 1 Setting up and connecting the device 7 1 1 Attach remove the compactplus stand clamp No...

Страница 23: ...level and to increase if required 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...

Страница 24: ...ress OK to confirm Setting 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 1 0 100 bar 75 mmHg 2 0 237 bar 178 mm...

Страница 25: ...p can continue to deliver after a preselected volume or a preselected time with a pre defined KVO rate see section 16 has been reached The duration of the KVO delivery is established in the service pr...

Страница 26: ...ce settings configured 8 1 Switching on the device Q Q Device connected to the mains elec tricity or battery fully charged Q Q Press the On Off key on the device The device will perform a self test No...

Страница 27: ...iously set values 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 S...

Страница 28: ...uration The bolus rate 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 6 Administer...

Страница 29: ...selected drug Q Q 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 3...

Страница 30: ...Calculating without patient data The delivery rate is calculated without any patient data being entered Q Q Select No patient data and press OK to confirm Q Q Select dose unit and press OK to confirm...

Страница 31: ...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 Q Q Check the pla...

Страница 32: ...gainst free flow Q Q Press the release lever and slide the drive head to the right Q Q Pull the syringe holder and turn it to the left Hold the syringe while doing so Q Q Remove the syringe Q Q Volume...

Страница 33: ...Press the down arrow key to end the priming 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...

Страница 34: ...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 s...

Страница 35: ...sound for 3 min Then the pump will automatically turn off Pressure too high There is an occlusion in the system The set level was exceeded Q Q The pump automatically implements a bolus reduction KVO...

Страница 36: ...g cases Q Q A syringe is inserted the pump is not delivering and the device is not oper ating for two minutes Q Q A value input was started but not completed and confirmed Q Q After the standby time h...

Страница 37: ...device is not in operation In this case the battery does not reach its original capacity after one charge it takes several charging and discharg ing cycles for the battery to achieve its original cap...

Страница 38: ...ARNING Risk of injury and or mal function from device modifications Q Q Do not modify the device Note Modifications and or incorrect repair of medical devices can lead to a loss of guarantee warranty...

Страница 39: ...mpet 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 with the start up trumpet curve and the set flow rate...

Страница 40: ...h mm 10 5 0 2 5 11 19 Beobachtungsfenster p x t min Prozentualer Flussfehler 31 5 10 Epmax Epmin Epmax Epmin 0 0 30 1 00 1 30 2 00 Zeit hh mm Fluss Q t ml h Anlaufkurven Trompetenkurven 20 ml Omnifix...

Страница 41: ...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 accelera...

Страница 42: ...e 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 start up b...

Страница 43: ...n 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 Teru...

Страница 44: ...otection Moisture protection IP34 Power supply Q Q 100 240 V 50 60 Hz connection via power cable or compactplus station Q Q 12 V DC 12 V CP interface cable Q Q 10 VA typ Internal battery Q Q Battery l...

Страница 45: ...20 C 55 C 4 F 131 F Q Q 20 90 without condensation Q Q 0 5 1 06 bar Weight Approx 2 3 kg Dimensions in mm W x H x D Approx 290 mm x 98 mm x 220 mm including compactplus stand clamp Safety check Every...

Страница 46: ...uous delivery rates bolus rates according to the syringe size used Syringe size ml Continuous delivery rate ml h Bolus rate ml h Preset bolus rate ml h 50 60 0 01 to 200 Or alternatively 0 01 to 999 9...

Страница 47: ...olving 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 protecti...

Страница 48: ...ts HF emissions rate is very low and it is unlikely to inter fere with nearby electronic equipment HF emissions According to CISPR 11 Class B The device is intended for use in all establishments inclu...

Страница 49: ...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 k...

Страница 50: ...r 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...

Страница 51: ...10 V m d 12 E1 P 80 MHz to 800 MHz d 23 E1 P 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 Interfe...

Страница 52: ...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...

Страница 53: ...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 interf...

Страница 54: ...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 Staff call interface lead CP 8718030 Connect device...

Страница 55: ...fferent staff call operating modes Switched off Static without off alarm Dyn without off alarm Alarm Operation Alarm Operation Switched off Switched on operating alarm 1 sec In static without off alar...

Страница 56: ...ade of PE 50 cm 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 o...

Страница 57: ...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 filter needle 8728861F 06 Original Perf...

Страница 58: ...ms 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 E Electrical connectio...

Страница 59: ...e therapy 32 S 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 Staff call 12 44 St...

Страница 60: ...49 0 56 61 71 0 Fax 49 0 56 61 71 20 44 www bbraun com 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 I0002700...

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