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Related Manuals for B. Braun Infusomat compact plus P
Summary of Contents for B. Braun Infusomat compact plus P
- Page 1 plus Infusomat compact ® Instructions for use » EN – Version 1.0 Valid for software 003A » » 0123 LLDorder 4900 - lw 04-2020 (Basis DE v3) 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 1 15.10.2020 17:47:22...
- Page 2 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 2 15.10.2020 17:47:22...
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Page 3: Table Of Contents
Table of Contents About this document 7.1.2 Operating the device on a stand..............7.1.3 Operating the device in the Purpose ................ plus compact station ..........Signs, symbols and tags ........7.1.4 Operating the device on a wall rail ....Warnings .............. - Page 4 Alarms Ordering data ..........................Device alarms 20.1 Recommended accessories for ............plus Infusomat® compact ....... Pre-alarms and operating alarms ....20.2 Power cords 9.2.1 Pre-alarms ..........................plus 9.2.2 Operating alarms ............. 20.3 Infusomat® compact P lines ....Reminder alarm ............
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Page 5: About This Document
About this document 1 About this document Signs, symbols and tags Purpose Symbol Meaning These instructions for use are part of the Prerequisite device and describe how to use the device Handling step: Follow the safely and correctly. specified instructions. Read these instructions for use before using this device. -
Page 6: Warnings
About this document Warnings Symbol Meaning Danger for people. Non-compliance will lead to death or serious injuries. DANGER Danger for people. Non-compliance could lead to death or serious injuries. WARNING Danger for people. Non-compliance could lead to minor injuries. CAUTION CAUTION Risk of damage or incorrect operation. -
Page 7: Symbols
Symbols 2 Symbols Symbols on the product and packaging Symbol Meaning Symbol Meaning Caution! Serial number Date of manufacture Consult instruction for use (year-month-day) Manufacturer Refer to instruction manual (Follow instruction for use) Humidity limitation Labeling of electric and electronic devices according to directive 2002/96/EC Temperature limit (WEEE) -
Page 8: Symbols On The Device's Display
Symbols Symbols on the device’s display Symbol Meaning Delivery in progress Delivery 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 Active communication via Infrared... -
Page 9: Intended Use
Intended use 3 Intended use plus plus The Infusomat® compact infusion The Infusomat® compact P infusion pump system is a transportable volumetric pump system is intended for use by quali- infusion pump used in combination with fied healthcare professionals in rooms used specific infusion lines and accessories. -
Page 10: Safety Instructions
This is even a legal requirement in sev- reported to B. Braun and the compe- eral countries. A corresponding form is tent authority of the country in which available from B. -
Page 11: Stacking
Safety instructions status LEDs and the display during properly inserted and primed. Discon- the self-test. nect it from the patient when chang- When fixing the device to a box rail, ing infusion line in order to prevent do not fix the device near the rail unintended dose administration. -
Page 12: Alarms And Staff Call
Connected electrical components must other than those specified, with the comply with IEC/EN specifications exception of those sold by B. Braun (e.g., IEC/DIN EN 60950 for data pro- Melsungen AG as replacement parts cessing equipment). Anyone who con-... -
Page 13: Enteral Nutrition
Safety instructions Enteral nutrition 4.1.9 plus The Infusomat compact P can be used for enteral nutrition. Do not use enteral fluids for the intra- venous infusion. This would lead to a risk of severe injury or death for the patient. Only use ENFit feed systems that have been designed and designated for enteral nutrition. -
Page 14: Description Of The Device
Description of the device 5 Description of the device Device overview Name Air sensor Active safety clamp Pressure sensor Upstream sensor Passive safety clamp 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 14 15.10.2020 17:47:25... -
Page 15: Interfaces
Description of the device Interfaces Name Pole clamp Accessory port (e.g. staff call, ambulance) Mains connection (socket for power cable. In the event of a power cut, the device switches to battery mode automatically) Infrared interface (communication in station) Guide rails for connecting pumps 38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd 15 15.10.2020 17:47:25... -
Page 16: Display And Control Elements
Description of the device Display and control elements Element Meaning On/Off key: Switches the device on and off Status display Green LED: Delivery Two-coloured LED (alarm indicator): - Yellow LED: Pre-alarm (only if enabled in Service Tool) - Red LED: Technical alarm, operating alarm Arrow keys: Scroll through menus Change settings... - Page 17 Description of the device Element Meaning 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:...
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Page 18: Display Overview
Description of the device Display overview Alarm status display Alarms are displayed via a notification on the display, a signal tone and a LED: Yellow: Pre-alarm. The alarm indicator LED lights up per- manently in yellow. Note: Yellow LED lights up only if enabled in Service Tool Display / Function Moving arrows: Delivery in... -
Page 19: Menu Structure/Device Functions
Menu structure/device functions 6 Menu structure/ Main menu > Rate, volume & time 6.1.1 device functions The device offers the option of entering the delivery rate, a volume or a time limit. If the volume limit and infusion time are entered, Main menu the rate will be calculated automatically. -
Page 20: Main Menu > Dose Calculation
Menu structure/device functions Main menu > Dose calculation Main menu > Settings... 6.1.3 6.1.4 Menu Meaning Menu Meaning Dose unit Night mode Turn night mode on/off Select unit: Brightness Enter brightness: μg Level 1 (=lowest level) - to - Level 9 (=highest level) Audio Select the volume: mmol... -
Page 21: Settings > Service
Menu structure/device functions Settings > Service 6.1.5 After the service code has been entered, the following service settings can be changed: Menu Meaning Language Select language Date Set date in DD.MM.YYYY format Time Set time Bolus rate Enter default bolus rate Switch KVO on/off Night Set night schedule:... -
Page 22: Set-Up And Start-Up
Set-up and start-up 7 Set-up and start-up Connecting the device to the 7.1.5 mains electricity Setting up and connecting DANGER! Risk of death from electric the device shock. Connect the power cable with mains plus Attach/remove the compact 7.1.1 connection to the device. pole clamp Position the power cable so that it plus... -
Page 23: Turning Night Mode On/Off
Set-up and start-up Configuring the pressure 7.3.4 alarm limit WARNING! Danger to the patient from an incorrectly set pressure alarm limit. Ensure that the pressure alarm level limit is set so that the alarm can be triggered in good time. It may be necessary to change the pressure Turning night mode on/off alarm limit due to various influencing fac-... -
Page 24: Configuring Service Settings
Set-up and start-up Configuring service settings 7.3.5 Alarm Pressure value Select Service... and press OK to con- level firm. 0.300 bar (225 mmHg) Enter the service code and press OK 0.400 bar (300 mmHg) to confirm. The “Service Menu” screen is displayed. 0.500 bar (375 mmHg) 0.700 bar (525 mmHg) 0.900 bar (675 mmHg) -
Page 25: Locking/Unlocking The Keypad
Set-up and start-up Switching KVO on/off Note: The keypad lock is not activated for all keys. It is always possible to stop the The pump can continue to deliver with a infusion using the Start/Stop and On/Off pre-defined KVO rate (see section 16) after keys. -
Page 26: Operation
Operation 8 Operation Inserting the infusion line: Push the active safety clamp down. – Device settings configured Switching on the device Device connected to the mains elec- tricity or battery fully charged. Press the On/Off 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... -
Page 27: Priming The Infusion Line
Operation The pump will calibrate the infusion line. Entries can be made during the calibration. However, the infusion can only be started after the infusion line has been successful calibrated. “ Line calibration ml/h CAUTION! Ensure that the line guide is straight and avoid sagging/bending, otherwise the line may be damaged and could cause incorrect dosing. -
Page 28: Use With Intrafix® Safeset
Operation Use with Intrafix® SafeSet Setting the infusion values Infusion line inserted and selected Note: If Intrafix® SafeSet is used, a VTBI is not required. Note: Depending on the last therapy, the pump starts either when the delivery rate is A special airtight filter membrane acts as entered or when a drug is selected. -
Page 29: Starting And Stopping The Infusion
Operation Starting and stopping Activating standby the infusion In the event of longer interruptions, the user has the option of retaining the set values Values for the treatment set and continuing the infusion at a later time. Press the Start/Stop key to start the Activating standby mode infusion. -
Page 30: Administering A Bolus
Operation Administering a bolus Note: Manual bolus administration is limited to a maximum of 10 s. The bolus There are three different options for bolus administration is automatically stopped, administration: but it can be continued by pressing the Manual bolus Bolus key again. Bolus with preselection of the bolus Note: An acoustic signal sounds for every... -
Page 31: Using The Drug Database
Operation Using the drug database Start the infusion with the Start/Stop key. DANGER! Danger to the patient from - or - incorrectly selected drug. Confirm the delivery rate by pressing Ensure that the correct drug has been selected. The “Overview” screen is displayed. Up to 3,000 freely selectable drug names, Select Vol./Time and press OK to including corresponding therapy data and... -
Page 32: Calculating The Dose
Operation Soft limits The main menu is displayed. Select Dose calculation and press OK Soft limits for rate/dose/bolus volume to confirm. and bolus rate can also be stored in the Select active substance unit and database. These can be exceeded with press OK to confirm. -
Page 33: Entering A Combination Of Delivery Rate, Volume And Time
Operation Calculation using: Weight Check the plausibility of the displayed values. Select Weight and press OK to confirm. Start the infusion with the Start/Stop Enter weight and press OK to confirm. key. Select dose unit and press OK to Entering a combination confirm. -
Page 34: Resetting The Therapy
Operation If the rate and time have been Remove the infusion line. – entered, the remaining time is Insert the new infusion line, adjusted. see section 8.2. Time changed: Start the infusion, see section 8.4. If only the rate has been entered, –... -
Page 35: Alarms
Alarms 9 Alarms Pre-alarms 9.2.1 In the event of a pre-alarm, an acoustic Device alarms signal sounds and a staff call is activated. The display remains in pre-alarm until the If a device alarm is triggered the infusion is operating alarm goes off. Pre-alarms do not stopped immediately. -
Page 36: Operating Alarms
Alarms Operating alarms 9.2.2 Display Meaning notification In the event of an operating alarm, the infusion is stopped. An acoustic signal “Pressure There is an occlusion in sounds, the red LED flashes and a staff call too high” the system. The set level is activated. -
Page 37: Reminder Alarm
Alarms Display Notifications Display Meaning notification Display Meaning “Pump Pump door was opened notification door open” during delivery. “No battery It is not possible to use the in the pump without a battery Reminder alarm device” Ask a service techni- cian to insert a battery Reminder alarms are triggered in the follow- ing cases:... -
Page 38: Cleaning And Care
Recommendation: nect from power and other devices (e.g. Use disinfectants manufactured by B. Braun: staff call). Meliseptol® Foam pure, Meliseptol® Wipes sensitive, Melsitt®, Melsept®, Hexaquart® WARNING! Do not allow liquids or or Hexaquart®... -
Page 39: Battery Operation And Maintenance
Cleaning and care Battery operation 10.2 Group Active Substance and maintenance Peroxide Hydrogen Peroxide, Peracetic Acid, The device is equipped with a modern Mono peroxyphthalat- lithium- ion battery that, at the time of hexahydrat delivery and after being fully charged, guarantees an operating time of 6 hours Aldehydes Glutaral, at 25 ml/h. -
Page 40: Changing The Battery
Decommissioning 12 Maintenance and repair Optimal battery life will then only be achieved if the pump is in continu- WARNING! Risk of injury and/or ous operation at room temperature malfunction from incorrect repair. in charged state. The battery display The device does not contain any parts on the pump is an approximate value that the user can repair themselves. -
Page 41: Warranty
Defective rechargeable battery packs can racy in this period on the trumpet be returned to B. Braun for further disposal. curve. WARNING! Do not modify this The physiological effect of the drug can... -
Page 42: Typical Start-Up And Trumpet Curves
Start-up and trumpet curves Typical start-up and 16.2 trumpet curves Start-up curves Trumpet curves Anlaufkurven Anlaufkurven Trompetenkurven Trompetenkurven Percentage flow error Fluss Q(t) [ml/h] Flow Q(t) [ml/h] Fluss Q(t) [ml/h] Prozentualer Flussfehler Prozentualer Flussfehler Intrafix Primeline Intrafix Primeline Intrafix Primeline Intrafix Primeline Delivery rate = 1 ml/h Delivery rate = 1 ml/h... -
Page 43: Alarm Times
Start-up and trumpet curves Alarm times These graphs show the accuracy and 16.3 uniformity of flow over time. Take into The following graphics show alarm times account: depending on pressure level. The delivery behaviour and the delivery Note: length of disposable and temperature accuracy are fundamentally affected might affect the time to alarm. -
Page 44: Technical Data
Technical data 17 Technical data Note: The data given, e.g. delivery accuracy, pressure alarm and alarm reaction times, apply at room temperature and with water as the test material. Different media viscosities and temperatures may lead to deviations. Parameter Value Type of device Volumetric infusion pump Product classification... - Page 45 Technical data Parameter Value Acoustic alarm signal Nine available levels: sound pressure range 45 dB(A) to 75 dB(A) Interfaces Cold connector for mains voltage Accessory port for interface cable 12 V CP and staff call IrDA infrared for communication in the station and for service Operating conditions Temperature...
- Page 46 Technical data Parameter Value Rate: ≥ 10 ml/h: KVO rate 3 ml/h KVO rate 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. Air detector Technical sensitivity: Detection of air bubbles ≥...
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Page 47: Electromagnetic Compatibility
Electromagnetic compatibility 18 Electromagnetic there fore recommended by B. Braun Melsungen AG, are used. Accessories compatibility are listed in section 20.1. plus WARNING! The Infusomat compact WARNING! If the equipment is oper- needs special precautions regarding ated in the vicinity of other equip- EMC. -
Page 48: Electromagnetic Interference Emissions
Electromagnetic compatibility Electromagnetic interference emissions 18.1 The device is designed to be used in the electromagnetic environmental conditions described plus below. Customers or users of the compact system or its components should ensure that the system is being operated in such an environment. Interference emission Compliance Electromagnetic environment... -
Page 49: Electromagnetic Immunity
Electromagnetic compatibility Electromagnetic immunity 18.2 The device is designed to be used in the electromagnetic environmental conditions described plus below. Customers or users of the compact system or its components should ensure that the system is being operated in such an environment. Immunity tests Test level Compliance... - Page 50 Electromagnetic compatibility Immunity tests Test level Compliance Electromagnetic EN 60601-1-2 level environment guidelines EN 60601-2-24 Voltage dips, < 5% UT ¹ Complies The supply voltage quality brief supply volt- for ½ periods through should be the same as that age interruptions (>95% dip) the use of of a typical commercial or...
- Page 51 Electromagnetic compatibility Immunity tests Test level Compliance Electromagnetic EN 60601-1-2 level environment guidelines EN 60601-2-24 Radiated RF 10 V/m 10 V/m The field strength should be interference 80 MHz to 2.5 GHz 80 MHz to lower than 10 V/m according to 6 GHz d = 1.2 x √P IEC 61000-4-3 80 MHz to 800 MHz d = 2.3 x √P...
- 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 2.5 GHz frequency range are designed to minimise the likelihood of...
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Page 53: Recommended Safe Distances Between Portable And Mobile Rf Telecommunications Equipment And The Infusomat Compact Plus
Electromagnetic compatibility Recommended safe Note: The higher value applies at 80 MHz 18.3 and 800 MHz. distances between Note: For transmitters whose rated power is portable and mobile not specified in the table above, the distance RF telecommunications can be determined using the equation for equipment and the the relevant column. -
Page 54: Instructions For Use For Accessories
Instructions for use for accessories 19 Instructions for use for Connect the STAFF CALL interface lead to the staff call system. accessories Set the staff call operating mode using the service programme. Follow the Interface lead 12 V CP 19.1 staff call system procedure. - Page 55 Instructions for use for accessories The device has two different staff call operating modes: Switched off Switched on Switched off Operating alarm Alarm Static without Opera- off alarm *) tion 1 sec. Alarm Dyn. without Opera- off alarm *) tion * In “static without off alarm” mode, the staff call can be disabled by pressing the OK key. Technical data Mode: Status...
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Page 56: Ordering Data
Ordering data 20 Ordering data Art. no. Name plus 8717070 Infusomat® compact plus Recommended accessories for Infusomat® compact 20.1 Art. no. Name plus 8717141 Station compact plus 8718020 Connection lead 12 V compact plus 8718030 STAFF CALL connection lead compact 8713135 Short stand SP Power cords 20.2... -
Page 57: Infusomat® Compact Plus P Lines
Ordering data plus Infusomat® compact P lines 20.3 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... -
Page 58: Index
Index Index Abbreviations 6 Electrical connection 13 Accessories 54 Electromagnetic compatibility 47 Accessories and consumables 12 Electromagnetic immunity 49 Administering bolus 30 Electromagnetic interference emissions 48 Air alarm 27 Ending the infusion 34 Alarms 35 Enteral nutrition 13 Alarms and staff call 12 Enter time 19 Alarm status 18 Enter volume 19... - Page 59 Notes Start-up and trumpet curves 41 Station 54 Night mode 23 Switching off 34 Switching on 26 Symbols 5, 7 Operation 11, 26 Symbols on the device‘s display 8 Ordering data 56 Symbols on the product and packaging 7 Pole clamp 15, 22 Tags 5 Power cords 56 Technical data 44, 55...
- Page 60 Manufacturer: Sales: B. Braun Melsungen AG B. Braun Melsungen AG 34209 Melsungen Hospital Care division Germany 34209 Melsungen Tel +49 (0) 56 61 71-0 Germany www.bbraun.com Tel: +49 (0) 56 61 71-0 Fax: +49 (0) 56 61 71-20 44 www.bbraun.com 38932401 •...
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