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59

WARRANTY / TRAINING / TSC* / SERVICE / CLEANING / DISPOSAL

Chapter 9

WARRANTY / TRAINING / TSC* / SERVICE /
CLEANING / DISPOSAL

Responsibility of the Manufacturer

The manufacturer, assembler, installer or importer is responsible for the effects
on safety, reliability and performance of the equipment only if:

•

assembly operations, extensions, re-adjustments, modifications or repairs
are carried out by authorized personnel,

•

the electrical installation of the relevant room complies with the
appropriate requirements (e.g. VDE 0100, 0107 and/or the IEC-publications
resp. national requirements),

•

the equipment is used in accordance with the Instructions for Use and

•

the Technical Safety Checks are carried out regularly.

Warranty

B. Braun provides 24 months warranty, as from the date of delivery, for every
Infusomat® Space (12 months for every Battery-Pack SP). This covers repair or
replacement of parts damaged as a result of design/manufacturing errors or
material defects. Modifications or repairs to the unit undertaken by the
user/operator or by third parties invalidate the warranty.

The warranty does not cover the following:
Elimination of faults attributable to incorrect/unauthorized handling, or to
normal wear and tear.

Defective rechargeable battery packs can be returned to B. Braun for further
disposal.

Separate collection for electrical and electronic equipment
(currently applicable to EU community only).

Training

B. Braun offers a training for version J. Please ask your local representative for
further details.

Technical Safety Check* / Service

The Technical Safety Check is recommended to be carried out every 2 years and
should be documented. Servicing work must be carried out exclusively by
B. Braun trained personnel.

The CE mark
confirms that this
medical product
complies with the
“Council Directive
on Medical Devices
93/42/EEC” dated
14th Junde 1993.

B. Braun
Melsungen AG

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Содержание Infusomat Space

Страница 1: ...Infusomat Space and Accessories Instructions for Use Valid for software 686J GB It is recommended that all pumps at your ward are equipped with the same software version ...

Страница 2: ...gesia PCA 23 3 5 Target Controlled Infusion TCI 25 3 6 Barcoding 31 3 7 Piggyback Function 32 3 8 Ramp and Taper Mode 34 3 9 Program Mode 37 3 10 Intermittent Mode 39 3 11 Dose Over Time 41 Chapter 4 Options 44 4 1 Occlusion Pressure 44 4 2 Data Lock 44 4 3 Bolus Rate 45 4 4 KVO Mode 45 4 5 Contrast Display Light Keypad Light 46 4 6 Alarm Volume 46 4 7 Date Time 46 4 8 Macro Mode 46 4 9 Language 4...

Страница 3: ...er of Battery Compartment Before changing the battery always disconnect the pump from the patient and switch off the device To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover away from device Slide green locking mechanism on back of battery up and take out battery pack for exchange A crank in order to open the pump door in case of emerge...

Страница 4: ...p pump device and slide bottom pump forward Fixaton of PoleClamp Universal Clamp Line up bar of pump with bar of PoleClamp and slide PoleClamp forward until locking mechanism clicks To remove press release button on frame push handle down and pull PoleClamp backwards Pole Fixation Push the opening of the PoleClamp against the vertical pole and lock the screw tightly Unscrew to release For vertical...

Страница 5: ... see documentation supplied with the product Symbol Explanation Type CF unit with defibrillation protection Protection class II device Labeling of electric and electronic devices according to directive 2002 96 EC WEEE CE mark compliant to Directive 93 42 EEC W ...

Страница 6: ...l transport environments Using TCI the scope of patients is Some parameter sets are using the Lean Body Mass LBM to individualize the parameterization The LBM calculation may furthermore restrict the scope of patients as it will not allow TCI for obese patients Using TCI the scope of procedures is Propofol Anaesthesia and Conscious Sedation Remifentanil Anaesthesia Qualified medical staff should d...

Страница 7: ...re If the pump falls down or is exposed to force it must be checked by the service department The displayed data must always be checked by the user prior to making further medical decisions During mobile use homecare patient transport inside and outside the hospital Make sure the device is securely fixed and positioned Positioning changes and severe shock can lead to minor changes in the delivery ...

Страница 8: ...t comply with the relevant IEC EN specifications e g IEC EN 60950 for data processing equipment The user operator is responsible for the system configuration if additional equipment is connected The international standard IEC EN 60601 1 1 has to be taken into account Safety Standards Infusomat Space satisfies all safety standards for medical electrical devices in compliance with IEC EN 60601 1 and...

Страница 9: ... anaesthetist for administration of drugs They need to be fully aware of the available literature for any parameter set used in association with a drug and need to refer to the prescribed information for rate and dosing limits Pharmacokinetic and pharmacodynamic interactions among anaesthetic drugs are known but are not taken into account into the calculation of the plasma and effect site concentr...

Страница 10: ...PATIENT SAFETY It is possible to completely switch off the TCI mode to avoid the use of TCI accidentally By using Infusomat Space a change of drug concentration will not be possible within the same therapy ...

Страница 11: ...ins connection Battery status Unit of drug application Active VTBI or time preselection Scrolling arrows indicate pump is infusing Set rate can be opened with l Set pressure limit and current pressure Therapy profile Typical display during infusion Total volume infused Alternatively the intermediate volume can be displayed Remaining time Remaining VTBI Cutline MENU STRUCTURE NAVIGATION MENU STRUCT...

Страница 12: ...it pressure by using c Pre alarms are indicated by a message on the display e g VTBI near end an audible tone and a flashing yellow LED To confirm a pre alarm press k In case of an operating alarm e g VTBI infused the infusion stops an audible tone sounds and the red LED flashes Confirm alarm by using k Confirming does not activate an acoustic feedback This hint pops up if a user tries to edit or ...

Страница 13: ...y of therapy parameters or press x and u to open the pump door in order to continue with inserting the line Caution You may only insert the line while the device is switched on and the line guide element is inserted Otherwise there is the danger of freeflow Pay attention to keep the roller clamp closed before inserting the infusion line especially at a tempera ture scale of 10 15 C Never leave the...

Страница 14: ...ed Note During priming all air and drop alarms are switched off Establish the patient connection Answer the question whether the old therapy is to be used either with u or d the question can be deactivated via the service manual If you select u the In the next step attach the white clip without twisting the line Properly insert the line into the air sensor Insert the freeflow clamp see red arrow i...

Страница 15: ...d is calculated by the pump If a volume and or time is preselected an arrow symbol is placed in front of one of these parameters in the Main Menu It is called the target During the infusion of the pump this target symbol is displayed next to the moving arrows in the run display this symbol is not visible in case TCI is used This indicates that the pump has been programmed either with a volume or t...

Страница 16: ...layed The max bolus time is limited to 10 sec Reaching this limit is indicated by an acoustic signal 2 Bolus with volume preselection Press n b Then press l and set bolus dose limit by using q Press n b to confirm and start bolus Depending on the service tool settings an acoustic signal will sound after finishing the bolus volume 3 Bolus with rate calculation Press n b Then press l and set bolus d...

Страница 17: ...ress x and open the pump door with u Press down the green opening lever completely until it locks in place remove the line and insert a new line Note If for an unknown reason the pump door cannot be opened anymore you need to take a crank from the inside of the battery compartment cover Use this crank to remove the emergency aperture cover of the pump Place the crank in the aperture and turn it cl...

Страница 18: ... s f to stop the infusion Then press o for less than 3 sec Confirm that the pump is supposed to switch to standby by pressing u The pump is now in Standby While the pump is in the standby mode it s display shows the drug and the remaining time for this mode Change of remaining time by pressing l Exit standby by pressing c As long as a disposable is inserted in the pump will use standby also in cas...

Страница 19: ...opped Select Status in Main Menu with t and press l Highlight intermediate volume in ml or intermediate time in h min with t and open parameter with l Reset values by pressing u Both parameter total volume and time are displayed in the pump as Total with the according unit and can be reset by starting a new therapy A second way to reset the parameters when the pump is in the Main Menu Press c answ...

Страница 20: ...rameters Setting parameters 1 Concentration as the amount of the active ingredient per volume Amount of the active ingredient Volume in ml 2 Where necessary Patient weight in kg or lbs or m2 or grams 3 Dose prescription time related as the amount of the active ingredient per min h or 24h time and patient weight related as the amount of the active ingredient per kg per min h or 24h or BSA 4 Where n...

Страница 21: ...t will alter the flow rate 3 3 Drug Library Up to 1200 drug names including therapy data information and up to 10 concentrations per drug can be stored in 30 categories These drugs can be subdivided in 50 Care Areas and 16 Patient Profiles The loading process into the pump can be performed via a separate PC program Space Upload Manager HiBaSeD Note The drug library can be started over the Start Up...

Страница 22: ... the Main Menu with t and start infusion with s f Note Care Area and Patient Profile can not be changed within a therapy incl Piggyback mode Initial Bolus Initial Bolus has to be configured in the Drug List Manager Use the drug library according to the instructions for use Select the desired drug with t and press l Before the initial bolus begins the bolus menu is displayed to allow editing the bo...

Страница 23: ...rwritten by the drug library values if selected Remote Drug Library update from Upload Manager Space Online Suite The file icon blinks every 2 s An update is available The Drug Library Upload starts as soon as the pump is in Passive mode Note You can cancel the upload by pressing c Please contact your local sales represantative in case you like to use Remote Drug Library update 3 4 Patient Control...

Страница 24: ...py can be checked in the menu Status Enter the Main Menu with c and select the Status with q An acoustic confirmation of demanded boli can be activated and modulated by t in Data Lock 3 Is a demand button connected the therapy symbol looks like this In case there is no demand button connected the therapy symbol looks like this The demand button is connected to the interface P2 at the rear side of ...

Страница 25: ...ic model PK model is a mathematic model to predict the concentration of a drug in the human body e g plasma level after a bolus or a continuous infusion of different duration A PK model is developed by measurement of plasma level values of a population of patients or volunteers and the respective statistical analysis A PK model mostly is a 2 or 3 compartment model indicating the volumes of the com...

Страница 26: ... action and the PK model is used to calculate the infusion rates required to achieve that concentration as quick as possible unless there is no restriction defined by the user A certain overshoot of the concentration in the plasma is resulting from this mode For effect site targeting there is a link between pharmacokinetics and pharmacodynamics necessary As the effect site compartment is considere...

Страница 27: ...1991 41 48 Effect site targeting No k10 min 1 0 228 Weight 0 302 0 0056 Age 53 0 443 0 0107 Weight 77 0 0159 LBM 59 0 0062 Height 177 0 196 1 29 0 024 Age 53 18 9 0 391 Age 53 0 0035 0 456 Schnider et al Anesthesio logy Vol 88 1998 1170 1182 Schnider et al Anesthesiology Vol 90 1999 1502 1516 Yes 4 27 2 05 0 0301 Age 40 5 1 0 0201 Age 40 0 072 LBM 55 2 6 0 0162 Age 40 0 0191 LBM 55 5 1 0 0201 Age ...

Страница 28: ...ccording to Instructions for Use Selecting a drug Select drug list category the TCI drugs need to be selected from the category TCI and desired drug by using q In this example Propofol Chapter 3 SPECIAL FUNCTIONS Available Concentrations Propofol Remifentanil Default Max Rate 1 200 ml h TCIProp Hard Limit Rate Max of pump Plasma Limit Default 400 Plasma Limit Hard Low 100 Plasma Limit Soft Max 450...

Страница 29: ...ation Important notes Be sure to enter the data corresponding to the respective patient Once the TCI is started patient data can not be altered Editing a target and starting TCI The editor window for setting the target comes up with the default value from the drug list Chapter 3 SPECIAL FUNCTIONS As a next step select the correct dilution concentration of the drug to be administered as well as the...

Страница 30: ...ow rate Cp Ce infused volume etc can be displayed The desired parameter can be selected by using t It is recommended to select Cp Ce In case it is necessary to change the target press l to edit the value Useful information while pump is running The line describes the course of Cp over the time and the area describes the course of Ce over the time The time window is 20 min 15 min past 5 min future ...

Страница 31: ...ere are two possibilities a The pump may be used for TCI with the same drug again but with a new patient use new disposables b The pump may go with the patient but in continuous mode without TCI 3 6 Barcoding Software version J has the barcoding functionality included but initially not activated Please contact your local sales representative in case you like to use barcoding Pressing r again shows...

Страница 32: ...manually or automatically Correspondingly if an automatic change is to be made automatically or manually is to be answered with u or d The rate and VTBI of the secondary infusion can be loaded via the dose rate calculation the drug library or are to be entered manually with q Start secondary infusion by pressing s f Device delivers the piggyback volume with the set piggyback rate Symbols in the he...

Страница 33: ...33 Chapter 3 SPECIAL FUNCTIONS Go to Set new Piggyback in the Special Functions Menu and confirm with l Note Resetting the data of the last secondary will also reset VTBI ...

Страница 34: ...teau rate is used as a continuous infusion Taper phase the pump rate is decreased linearly after the continuous phase until the KVO rate is reached or pump ist stopped in a predefined time Down Time Example Ramp and Taper should only be performed by an experienced user that is familiar with the principles of the Ramp and Taper function and properly trained in using the present device Note The acti...

Страница 35: ... now by pressing s f Starting Ramp and Taper via Special Function Menu Switch on pump with o and wait until self check is finished Insert disposable Go to Special Functions Menu and select Ramp and Taper Press l to enter parameters and k to confirm After entering all desired parameters the pump can be started by pressing s f The status of the therapy is shown in the upper part of the display of th...

Страница 36: ...g decreasing the VTBI the continuous phase is prolonged shortened to infuse the new entered VTBI completely with the end of the taper phase Note The delivery of drugs can be stopped and started again in Ramp and Taper Mode at any time by pressig s f Ramp and Taper is stopped immediately without Taper phase and started without a new Ramp phase Immediate Taper Down By chosing the Immediate Taper Dow...

Страница 37: ...nt device Note The active Program Mode function always displays this icon in the Display Note Bolus function is disabled for Program Mode Set Profile Parameters The therapy can be started directly via the drug library or via the Main Menu Special functions Starting Program Mode via Drug Library Note Program Mode settings have been configured in the Drug List Manager before and have been uploaded i...

Страница 38: ...VTBI with q After entering all desired parameters the pump can be started by pressing s f In the upper part of the display the icon for Program Mode appears The screen shows the following Only the VTBI may be changed during an infusion that is running Press C to check upcoming Program Mode intervals in Main Menu It is possible to cancel one step of the running therapy All following steps in the pr...

Страница 39: ... time during the therapy in which the entered rate is active Example Intermittent Mode should only be performed by an experienced user being familiar with the principles of the Intermittent Mode and properly trained in using the present device Note The active Multi Dose Mode function always displays this icon in the Display Note Regular Bolus function is disabled for Intermittent Mode In Intemitte...

Страница 40: ...user before starting the infusion The pump can be started now by pressing s f Starting Intermittent Mode via Special Function Menu Switch on pump with s f and wait until self check is finished Insert disposable Go to Special Functions Menu and select Intermittent Mode Press l to enter parameters and k to confirm After entering all desired parameters the pump can be started by pressing s f In the u...

Страница 41: ... is an own therapy and cannot be used in combination with another therapy except Piggyback It can only be activated via the Drug List Manager It can be used for standard infusion and or piggyback The active Dose Over time function is always symbolised with a characteristical symbol in the Display If besides DOT the piggyback therapy is active a combined symbol for both therapies will be displayed ...

Страница 42: ...e drug library according to the Instructions for Use Select a drug by using t and press l The pump now offers the possible therapy profiles Select Dose over Time with t and press l The editor for Total Dose is shown if a drug with therapy Dose over Time is sel ected from drug library and no default value for Total Dose was entered in libr ary The editor is also shown if the Total Dose is edited in...

Страница 43: ...values in the Main Menu while the pump is delivering Run Menu The time is used to control the therapy For this reason the remaining time is shown big digits in menu Run The parameter in the lower left corner can be scrolled Set to Rate when leaving the pump SPECIAL FUNCTIONS Chapter 3 ...

Страница 44: ...three security levels Level 1 A modification of values as well as a bolus application are not possible but a change of the disposable can be conducted It is possible to navigate through all menus and status data can be checked Starting interrupting and switching the pump off is possible Level 2 This level has the same performance characteristic as described under level 1 and additional will not al...

Страница 45: ...ing the code In order to deactivate the function select Off in the data lock press k enter the code and press k again 4 3 Bolus Rate Open bolus rate in Options Menu with l Change bolus rate with q and confirm setting with k Note Set bolus rate according to therapy requirements Take care not to overdose Given a bolus rate of 1200 ml h e g 0 33 ml are reached within just one second 4 4 KVO Mode The ...

Страница 46: ... confirm with k 4 6 Alarm Volume Chose between 9 different alarm volume levels Open alarm volume in Options Menu with l Set volume with l or r and confirm entry with k 4 7 Date Time Open date time in the Options Menu with l Modify date and time with q and confirm the setting with k 4 8 Macro Mode The infusion rate appears larger on the display when the macro mode is activated and the pump is infus...

Страница 47: ... upstream pressure sensor that detects an occlusion e g closed roller clamp kinked line between the container and the pump The higher the pressure level is set at the lower the pressure level must drop before triggering an upstream occlusion pressure alarm Access upstream pressure in Options Menu by pressing l Choose between nine pressure levels 1 lowest level 9 highest level by pressing l or r an...

Страница 48: ...al Press k to acknowledge the audible alarm alarm text and staff call The red LED remains on until the infusion is restarted 5 1 Device Alarms When a device alarm occurs the infusion is immediately stopped Press o to switch off the device Then switch the device on again In case of a repeated device alarm you must close the rollerclamp disconnect from the patient open the front door of the pump and...

Страница 49: ...ad to an interruption of the infusion An audible tone sounds the red LED flashes and a staff call is activated The display states Alarm and the reason for the operating alarm The signal tone and the staff call are turned off with K Corrections are to be made according to the alarm reason Display message Alarm reason VTBI infused The preselected volume was infused Continue therapy or select new the...

Страница 50: ...r If necessary replace the drop sensor or preselect VTBI time and proceed with therapy Check upstream The upstream sensor triggers an alarm Check if roller clamp is closed or infusion line is kinked If a drop sensor is connected the upstream alarm is deactivated Air bubble Accumulated air Air inside the system Check the line for small air bubbles and disconnect from patient to repeat priming if ne...

Страница 51: ...isplayed and or a yellow red and blue LED blink then the pump is in the service mode and is not permitted to be used on a patient The pump must then be checked by a service technician 5 3 Reminder Alarms Reminder alarms only occur in two cases 1 A line is inserted the pump does not deliver no value is edited and the device is not operated for two minutes An acoustic tone sounds the yellow LED blin...

Страница 52: ...If inproper entries are made the display states corresponding hints e g Attention Rate is out of range The parameter can not be modified and an audible tone so unds These hints disappear after a few seconds and don t need to be confirmed ...

Страница 53: ...f the battery capacity is sufficient for the proposed use When the battery symbol blinks permanently 1h the battery must be checked by a technician and replaced if necessary Directions for optimal battery use The actual battery life may vary due to ambient temperature varying load e g frequent boluses The optimal life time of a battery pack will only be reached if it s completely discharged from t...

Страница 54: ...m time can no longer be maintained In this case it is necessary to perform a battery maintenance To initiate the discharge process the message Battery maintenance and the k key will be displayed after switching the pump off By pressing k and u the discharge process will start The process is interrupted by switching the pump on again IIf the battery maintenance is to be continued a new activation i...

Страница 55: ...e disposable used Deviations from the technical data of the pump cannot be excluded if lines disposables other than those stated in the order data are used START UP GRAPHS AND TRUMPET CURVES Trumpet Curves Measured values for second hour in each case Measurement interval t 0 5 min Observation interval p x t min Start Up Graphs Measurement interval t 0 5 min Measurement duration T 120 min Flow Qi m...

Страница 56: ...nditions Relative humidity 30 90 without condensation Temperature 10 40 C Atmospheric pressure 500 1060 mbar Storage conditions Relative humidity 30 90 without condensation Temperature 20 55 C Atmospheric pressure 500 1060 mbar Type of battery pack rechargeable NiMH Operating time of rechargeable battery Approx 4 hours at 100 ml h Recharging time Approx 6 hours Weight Approx 1 4 kg Dimensions W x ...

Страница 57: ...ctively 1 5 ml h cumulated value over 1 h from air bubbles size 0 01ml Sensitivity upstream sensor 9 levels from 0 12 bar to 0 21 bar pressure reduction Occlusion alarm pressures 9 levels up to 1 2 bar Mechanical occlusion pressure limit under fault conditions Occlusion alarm pressure max 2 1 bar 210 kPa Max bolus volume 2 ml History protocol 1000 last history entries 100 events for system diagnos...

Страница 58: ...NICAL DATA Note The technical data stated in this Instructions for Use manual were determined with the Infusomat Space lines as of Type Standard 870 0036 SP These technical data can change when using set configurations ...

Страница 59: ...SP This covers repair or replacement of parts damaged as a result of design manufacturing errors or material defects Modifications or repairs to the unit undertaken by the user operator or by third parties invalidate the warranty The warranty does not cover the following Elimination of faults attributable to incorrect unauthorized handling or to normal wear and tear Defective rechargeable battery ...

Страница 60: ...nning water Spray disinfectant on the peristalsis and wipe it with a soft cloth Caution Do not touch peristalsis with sharp object When reinserting the line guide element make sure that it is not damaged and that it audibly locks in Prime the next infusion line in order to ensure the proper position of each finger Do not use Hexaquart or an other alkylamine containing disinfectants Disposal The pu...

Страница 61: ...ace and Patient Safety Power Supply SP 8713110A 8713114A The Power Supply SP is adequate to supply power for a single pump and one SpaceControl 1 Connect plug of Power Supply SP with socket P2 on back of pump ensure that plug clicks 2 Push power plug into wall outlet Note For disconnection from pump press lever on plug down A maximum of three plugs can be stacked upon each other in socket P2 Techn...

Страница 62: ...amp on the pump 2 Plug the short stand into the aperture on the PoleClamp make sure that it audibly locks in 3 To remove the short stand Press the white button at the lower end of the PoleClamp and remove the short stand Battery Pack SP NiMH 8713180 Battery Pack SP NiMH incl Pin 8713180A For further information on the Battery Pack SP NiMH see Battery Operation Interface Lead CAN SP 8713230 Interfa...

Страница 63: ... pump to a patient during external car battery charging Note A maximum of three plugs can be stacked upon each other in socket P2 Connection Lead for Staff Call SP 8713232 To connect the Infusomat Space to staff call use the Connection Lead for Staff Call SP The staff call needs to comply with the requirements of VDE 0834 consider country specific regulations Note Test staff call signalling before...

Страница 64: ... on 1 sec 1 sec 1 sec turned off static without Off Alarm dynamic without Off Alarm dynamic with Off Alarm Operating Alarm in the mode static without Off Alarm the staff call can be surpressed with k Technical Data Polarity of connexion is arbitrary max 24 V 0 5 A 12 VA Chapter10 INSTRUCTIONS FOR USE ACCESSORY Alarm Operation white and green Connecting Wire white and brown disconnected connected c...

Страница 65: ... tape for fixation of the demand button at the patient s arm Line fixation connection between hook and loop tape and demand button Metal clip alternatively for fixation at the bed sheet Cable strap for wrapping the cable of the demand button Fixation of the demand button at the wrist or at the bed sheet Usage of the cable strap ...

Страница 66: ...0 Battery Pack SP NiMH incl Pin 871 3180A Interface Lead CAN SP 871 3230 Connection Lead SP 12 V 871 3231 Connection Lead for Staff Call SP 871 3232 Space PCA Kit 871 2554 Infusomat Space Lines IV Standard Single packed 870 0036 SP Single packed Extra long 3M 827 0350 SP Neutrapur 825 0731 SP with Eurofix injection port for needle access 870 0087 SP Neutrapur with Safeflow needle free Y port 870 0...

Страница 67: ...ort and integrated BCV 825 0710 SP secondary line with integrated BCV 406 2877 CytoSets Secondary Lines Preparation Cyto Set Mix Neutrapur with 1 Safesite valve and integrated BCV A 2902 N Cyto Set Mix Neutrapur with 1 Safesite valve and 0 2 Sterifix particle filter A 92023 N Cyto Set Line Neutrapur with integrated BCV A 25811 NF Cyto Set Line Neutrapur A 25812 NF Application Infusomat Space Lines...

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Страница 70: ...ched 100 chlorine free Date of last revision November 2010 B Braun Melsungen AG Sparte Hospital Care 34209 Melsungen Germany Tel 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 ...

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