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47

Electromagnetic compatibility

18 Electromagnetic 

compatibility

   WARNING!  The   Infusomat   compact

plus

 P 

needs special precautions  regarding 

EMC. The device must be set up, 

 powered on and services in accord-

ance with the EMC information in 

this section. The safe distances and 

ambient/operation conditions specified 

must be ensured and complied with.
Portable and mobile RF communica-

tions equipment can affect medical 

electrical equipment. Portable RF 

communications equipment (radio 

communications equipment) (including 

its accessories, e.g. antenna cables) 

should not be used closer to the 

Infusomat   compact 

plus

 P than the safe 

distance specified in this section. 
Non-compliance could lead to a 

decrease in the device’s performance.
Portable and mobile RF comunications 

equipment can affect medical electri-

cal equipment.

   WARNING!  The use of accessories, 

transducers, power cords and cables 

other than those specified, with the 

exception of transducers and cables 

sold by B. Braun Melsungen AG 

as replacement parts for internal 

components, may result in increased 

emissions or decreased immunity of 

the   compact 

plus

 System.

   WARNING! 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 may be disturbed. Maintain the 

protective distances recommended by 

the manufacturers of these devices.

   WARNING! In Order to meet with 

the following compliance levels, only 

original accessories and replace-

ment parts may be used. Otherwise, 

there may be increased emissions or 

reduced device immunity.
If the device is used in a system 

involving other devices (e.g. elec-

tro surgery), this system should be 

checked to ensure correct operation 

of the system.

CAUTION!: The device is unsafe to use in 

proximity to Magnetic Resonance Imaging 

(MRI) equipment. The device must not be 

used near a Magnetic Resonance Imaging 

unit without protection.

Note: 

The following guidelines may not be 

applicable in all situations. Electro mag-
netic wave propagation is affected by the 
absorptive and reflective qualities of the 
surrounding structures, objects and people.

38932401_Infusomat_compactPlusP_EN_IFU_1020_v5.indd   47

15.10.2020   17:47:31

Summary of Contents for Infusomat compact plus P

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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