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Operating Manual

SAFE HANDLING

Software-Version 2.6

B|BRAUN

Chapter 1

Page 2 of 10

SHARING EXPERTISE

2.6_CA-EN_03

1.1 ABOUT THESE INSTRUCTIONS FOR USE

These instructions for use form an integral part of

the H.E.L.P. Plasmat® Futura machine. They describe

the appropriate and safe use of the H.E.L.P. Plasmat®

Futura machine at all stages of operation.

The H.E.L.P. Plasmat® Futura machine must always be

used in accordance with the instructions for use.

Always keep the instructions for use at the H.E.L.P.

Plasmat® Futura machine for later use.

Pass on instructions for use to any future user of the

H.E.L.P. Plasmat® Futura machine.

1.1.1 Validity

Art.no.

These instructions for use apply to H.E.L.P. Plasmat®

Futura machines with the article numbers (art. no.):

• 7062100

• 706210A (110 V/120 V)

Software version

These instructions for use apply to software version

2.6.

1.1.2 Target Group for the Instructions for Use

The target group for these instructions for use is

specialist medical staff.
The H.E.L.P. apheresis should be applied and

supervised only by physicians with sufficient

experience in the execution of extracorporeal

procedures for blood purification.
The H.E.L.P. Plasmat® Futura machine may only be

used by persons instructed for its appropriate

operation.

1.1.3 Warnings, Notices and Symbols in These

Instructions for Use

Warnings in these instructions for use point out

particular hazards for users, patients, third parties

and the H.E.L.P. Plasmat® Futura machine. They also

suggest measures that can be taken to avoid the

respective hazard.
There are three levels of warning notices:

Содержание H.E.L.P. Plasmat Futura

Страница 1: ...utura Operating Manual Software Version 2 6 Status November 2011 2 6_CA EN_03 B BRAUN SHARING EXPERTISE Manufacturer B Braun Avitum AG 34209 Melsungen Germany Tel 49 56 61 71 0 Fax 49 56 61 71 35 10 O...

Страница 2: ...2 Preparing the Solutions 3 3 Setting Up the Bags 3 4 Setting up the H E L P Futura Set 4 PRIMING AND RINSING 4 1 Automatic Priming and Rinsing 4 2 Parameter Setting 4 2 1 4 2 2 Parameter Setting in...

Страница 3: ...isposables Consumables and Accessories Replacement Parts 9 2 5 Cleaning and Disinfection 9 3 Technical Data 9 3 1 Technical Data General 9 3 2 Recommended Safe Distances 9 3 3 Technical Data Component...

Страница 4: ...uctions for Use 1 1 4 Abbreviations 1 2 INTENDED USE AND INDICATIONS 1 3 CONTRAINDICATIONS 1 4 SIDE EFFECTS 1 5 SPECIAL HAZARDS AND PRECAUTIONS 1 5 1 Special Patient Conditions 1 5 2 Electrical Hazard...

Страница 5: ...L P Plasmat Futura machines with the article numbers art no 7062100 706210A 110 V 120 V Software version These instructions for use apply to software version 2 6 1 1 2 Target Group for the Instruction...

Страница 6: ...rce of the danger are listed and possible consequences if measures are not followed This is the list of measures to prevent the hazard This is the list of important information directly or indirectly...

Страница 7: ...e Version 2 6 B BRAUN Chapter 1 Page 4 of 10 SHARING EXPERTISE 2 6_CA EN_03 PPF Precipitate filter pressure PPL Plasma pressure PRP Reinfusion pump PV Venous pressure SAD Safety air detector SAK Safet...

Страница 8: ...utely remove LDL C from the plasma of the following high risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated Group A Funct...

Страница 9: ...the suitable therapy based on medical and analytical findings and the general health and condition of the patient 1 4 SIDE EFFECTS Occasionally the occurrence of angina pectoris has been observed In...

Страница 10: ...he subsequent course of the respective serum concentration be monitored WARNING Risk to patient due to thrombosis if the heparin is completely neutralised by protamin chloride sulphate These substance...

Страница 11: ...ith the valid standards for interference suppression and EMC It cannot however be guaranteed that no electromagnetic interaction with other devices will occur Examples mobile phones computer tomograph...

Страница 12: ...AMI IEC 60601 1 2001 Additional equipment connected to the analog or digital interfaces of the H E L P Plasmat Futura machine must demonstrably meet the relevant IEC specifications e g IEC 60950 for d...

Страница 13: ...t of medical treatment rooms i e VDE 0100 part 710 and or IEC stipulations The device may only be operated if the manufacturer or an authorized person acting on behalf of the manufacturer has carried...

Страница 14: ...IPTION 2 1 PRINCIPLE 2 2 FUNCTION 2 3 MACHINE 2 3 1 Front View 2 3 2 Upper Module 2 3 3 Central Module 2 3 4 Controls on the Central Module 2 3 5 Rear of the Machine 2 3 6 Symbols on the Machine 2 4 M...

Страница 15: ...n The cellular blood components are directly reinfused to the patient along with the treated plasma The plasma is mixed with a heparinized acetate buffer at a ratio of 1 1 LDL fibrinogen and Lp a toge...

Страница 16: ...are mixed at a ratio of 1 1 The resulting precipitate is filtered in the subsequent precipitate filter The precipitate filter pressure transducer PPF monitors the inlet pressure of the precipitate fi...

Страница 17: ...reinfused to the patient via the venous line Pumps Sensors Actuators BP Blood pump PA Arterial pressure SAK Safety air clamp HP Heparin pump PBE Prefilter pressure HAK Heparin adsorber clamp PBP Plas...

Страница 18: ...n to valve for automatic level setting in the heparin adsorber air chamber HCLD 3 Manual control for level setting in the heparin adsorber air chamber HCLD 4 Reinfusion pump PRP 5 Holder for heparin a...

Страница 19: ...ressure PDF transducer 11 Upper holder for H E L P Futura kit 12 Blood leak detector BLD 13 Heparin adsorber clamp HAK 14 Venous safety air detector SAD 15 Brake pushbuttons for releasing applying the...

Страница 20: ...on with the red brake locking button the brake can be applied The brake can then be released with the green brake release button 2 3 5 Rear of the Machine 1 Monitor support 2 IV pole 3 On Off switch 4...

Страница 21: ...ne Observe Instructions for use Observe safety information Application device type B Classification acc to IEC 60601 1 Electrical ground H E L P Plasmat Futura OFF H E L P Plasmat Futura ON Alternatin...

Страница 22: ...n e g prompt for turning over the dialyzer during the priming and rinsing phase When this key is active the yellow LEDs above it light These LEDs blink during adjustment of parameters with relevance t...

Страница 23: ...rapy phase priming therapy reinfusion and current status of the phase stand by running 2 Alarm Note line This area of the monitor displays alarm texts and warning messages 3 Display area This area dis...

Страница 24: ...A EN_03 Flow Scheme The Help screen can be selected from any screen with the key The symbols and abbreviations used for the different pressures in the display areas are explained on the Help screen To...

Страница 25: ...treatment unit for the H E L P Plasmat Futura comprises the following 2 5 1 H E L P Futura Set The H E L P Futura set includes all line systems and filters required for performing H E L P treatment H...

Страница 26: ...ating Manual PRODUCT DESCRIPTION Software 2 6 B BRAUN Chapter 2 Page 13 of 15 SHARING EXPERTISE 2 6_CA EN_03 Arterial line Dialysate line 1 x 5 l empty bag for rinse solution 1 3 x 7 l drain bags 2 1...

Страница 27: ...P Futura set all solutions required for performance of a treatment 2 x 3000 ml H E L P 0 9 NaCl sodium chloride solution 1 x 3000 ml H E L P sodium acetate buffer 1 x 30 ml H E L P heparin sodium 300...

Страница 28: ...erating Manual PRODUCT DESCRIPTION Software 2 6 B BRAUN Chapter 2 Page 15 of 15 SHARING EXPERTISE 2 6_CA EN_03 1 x 1500 ml and 1 x 500 ml H E L P 0 9 NaCl sodium chloride solution non PVC for reinfusi...

Страница 29: ...EPARATION Software 2 6 B BRAUN Chapter 3 Page 1 of 9 SHARING EXPERTISE 2 6_CA EN_03 3 PREPARATION 3 1 SWITCHING ON AND SELF TEST 3 2 PREPARING THE SOLUTIONS 3 3 SETTING UP THE BAGS 3 4 SETTING UP THE...

Страница 30: ...tions are marked with PASSED All three rows of numbers are completely presented in the correct sequence 0 1 2 3 4 5 6 7 8 9 completely and in the three fonts that can be displayed by the machine After...

Страница 31: ...ll is not equipped with solutions and the pressure transducers are not screwed to the respective connections Preparations for therapy may start only when all self tests are performed successfully Afte...

Страница 32: ...olution H E L P BicEL Remove the outer packing from the bag Place the bag on a firm base and press the smaller chamber of the bag with both hands until the seal seam between the two chambers is opened...

Страница 33: ...e of the machine One 5L empty bag with the connectors upturned One prepared bag with physiological saline solution One double chamber bag with the physiological saline solution for reinfusion Physiolo...

Страница 34: ...nfusion pump marked green 2 Place the pump segments of the plasma buffer line successively into the plasma buffer pump marked brown and yellow 3 Place the plasma line coming from the plasma filter int...

Страница 35: ...bag with the saline solution Break the seal and fill the line manually until the saline solution reaches the plasma line Then close the clamp at the reinfusion line 5 Mount the heparin adsorber in it...

Страница 36: ...the blood pump 3 Connect the arterial feeder line to the inlet of the plasma filter 4 Connect the arterial line to the prepared saline bag which is hanging on the IV pole 5 Screw on the two pressure t...

Страница 37: ...the Hansen connector is firmly seated Note Connect red with red and blue with blue 3 Place the blue inflow line into the dialysate air detector DAD 4 Insert the pump segment of the dialysate line into...

Страница 38: ...19 SHARING EXPERTISE 2 6_CA EN_03 4 PRIMING 4 1 AUTOMATIC PRIMING AND RINSING 4 2 PARAMETER SETTING 4 2 1 Parameter Setting in the Main Parameter Screen 4 2 2 Parameter Setting in the Parameter Overvi...

Страница 39: ...r 1 Display of blood pump activity Blood pump stands still One still four blinking drops Blood pump runs Increasing and decreasing number of drops 2 Current time and date 3 Current phase Priming and s...

Страница 40: ...ERTISE 2 6_CA EN_03 Display area Blood flow in ml min Heparin flow in ml h Heparin bolus in ml Autostop heparin in min Plasma flow in ml min Rinsing time Actual Rest in min Rinsing volume Actual Rest...

Страница 41: ...bar the screen changes to the Parameter Overview Final System Check Ensure that all connections between the line system and the filters have been made Tighten all screw locks as well as the Hansen co...

Страница 42: ...rizing blood side is displayed in the message line Automatic Filling of Blood Side During automatic filling the arterial line the plasma filter and the venous line are rinsed and filled by default wit...

Страница 43: ...tection in the heparin adsorber air chamber and the venting of the connection line to the heparin adsorber are performed This step includes the filling of the dialyzer on the plasma side Step 8 The Wa...

Страница 44: ...nsing volume If you wish to increase the rinsing volume Select the Parameter Setting command in the menu bar Select the Rinsing volume parameter and change this parameter The rinsing volume can be set...

Страница 45: ...d Side If you wish to increase the rinsing volume in the blood circuit Start the blood pump with the key When you have sufficiently rinsed the blood side press again the key to finish rinsing When inc...

Страница 46: ...ith the key All parameters which can be changed are displayed in red The currently selected parameter has a gray background The range which can be selected is displayed in the Setting window Using the...

Страница 47: ...dition the LEDs above the key blink To quit the screen for setting the parameters press the key The cursor changes back to the menu bar of the Main Parameter screen and the menu item Start Priming If...

Страница 48: ...s the possibility of additionally removing the existing physiological saline solution or to balance the physiological saline solution required for blood reinfusion When setting a balance it must be ob...

Страница 49: ...SE 2 6_CA EN_03 Autostop Heparin Default setting 0 min Range 0 60 min Step size 5 min Autostop heparin indicates how long before the end of the therapy the heparin administration is stopped If the the...

Страница 50: ...rview Screen Using the rotary knob and the key change to the Parameter Overview screen To set the parameters select the Parameter Setting menu item with the cursor in the Parameter Overview screen and...

Страница 51: ...ry knob select the individual parameters The following parameters can be set in the priming and rinsing phase Plasma volume ml Balance g Plasma flow in Heparin flow ml h Heparin bolus ml Autostop hepa...

Страница 52: ...a parameter is relevant for safety the currently set value is shown in the Setting window above the setting range In addition the LEDs above the key blink WARNING Risk to patient due to blood loss si...

Страница 53: ...window Min Default setting 20 mmHg Range 10 40 mmHg Step size 5 mmHg PV window Max Default setting 40 mmHg Range 20 100 mmHg Step size 5 mmHg PPL min Default setting 10 mmHg Range 20 10 mmHg Step size...

Страница 54: ...Operating Manual PRIMING AND RINSING Software Version 2 6 B BRAUN Chapter 4 Page 17 of 19 SHARING EXPERTISE 2 6_CA EN_03 Ratio Dialysate Plasma Default setting 4 Range 4 12 Step size 1...

Страница 55: ...knob and the key change to the Flow Scheme screen To set the parameters select the Parameter Setting menu item with the cursor in the Flow Scheme screen and activate it with the key The screen change...

Страница 56: ...4 2 4 Additional Functions During Priming and Rinsing in the Main Parameter Parameter Overview and Flow Scheme screens the Additional Functions menu item is not active New Therapy To cancel the primi...

Страница 57: ...2 6_CA EN_03 5 THERAPY 5 1 STARTING THE THERAPY 5 2 TERMINATING THE THERAPY 5 3 PARAMETER SETTING 5 3 1 Parameter Setting in the Main Parameter Screen 5 3 2 Parameter Setting in the Parameter Overvie...

Страница 58: ...arning window W32 Activate therapy mode Confirm the message with the key The change to the therapy phase is possible only when the minimum rinsing volume of 2400 ml has been reached The screen changes...

Страница 59: ...arterial line Remove the empty bag from the IV pole Remove the clamps from the bag and the buffer line and make sure that all bag break seals are open At this point at the latest enter the parameters...

Страница 60: ...olume substitution Connect the patient s arterial line as well as the venous line to the patient s accesses for drawing blood and blood return respectively Fill the blood side line system by pressing...

Страница 61: ...rst the blood flow rate to reach the desired target value after 5 minutes Subsequently gradually increase the plasma flow rate to achieve the appropriate value after another 10 minutes CAUTION Risk to...

Страница 62: ...Confirm with the key Confirm the message W35 Activate reinfusion Press OK to proceed in the Warning window by pressing the key to change to the reinfusion phase CAUTION Risk to patient due to blood a...

Страница 63: ...n and activate it with the key All parameters which can be changed are displayed in red The currently selected parameter has a gray background The Setting window displays the allowable range Using the...

Страница 64: ...ter is relevant to patient safety the currently set value is shown in the Setting window above the setting range In addition the LEDs above the key blink To quit the screen for setting the parameters...

Страница 65: ...w displays the allowable range Using the rotary knob you can select the individual parameters The following parameters can be set in the therapy phase Plasma volume ml Balance g Plasma flow Heparin fl...

Страница 66: ...s relevant to patient safety the currently set value is shown in the Setting window above the setting range In addition the LEDs above the key blink WARNING Risk to patient due to blood loss since inc...

Страница 67: ...key change to the Flow Scheme screen To set the parameters select the Parameter Setting menu item with the cursor in the Flow Scheme screen and activate it with the key The screen changes to the Sett...

Страница 68: ...d by pressing the key If the therapy is prematurely terminated the Warning window with the following message is first displayed W35 Activate reinfusion and must be confirmed with the key The next proc...

Страница 69: ...ection The active menu items are shown in black labeling and the inactive items in gray labeling The selected active field has a green background Heparin bolus To administer a heparin bolus during the...

Страница 70: ...ministered the Stop Bolus menu item in the submenu is active The heparin bolus can be interrupted at any time by pressing the key During heparin administration the symbol of heparin bolus drop alterna...

Страница 71: ..._03 6 REINFUSION 6 1 PLASMA REINFUSION 6 2 BLOOD REINFUSION 6 3 TERMINATING THE TREATMENT 6 4 PARAMETER SETTING 6 4 1 Parameter Setting in the Main Parameter Screen 6 4 2 Parameter Setting in the Para...

Страница 72: ...Reinfusion Screen Blood flow in ml min Blood reinfusion time in min Blood reinfusion volume in ml Reinfusion flow in ml min Reinfusion time in min Reinfusion volume in ml Therapy time Actual Rest in h...

Страница 73: ...lasma filter Turn over the plasma filter the precipitate filter and the heparin adsorber After performing all steps confirm with the key Start plasma reinfusion by selecting the Start Plasma menu item...

Страница 74: ...low is maintained The default setting of the plasma reinfusion volume is 400 ml The Warning window on the display explains the next procedure choices Stop blood pump to pass to blood reinfusion OR PRE...

Страница 75: ...and connect the line to the 500 ml compartment of the saline bag on the IV pole Close the clamp of the reinfusion line Take the reinfusion line from the saline bag and screw it to the port of the veno...

Страница 76: ...s line to the venous chamber The saline solution is now pumped through the membrane of the plasma filter to the plasma side of the filter In this manner the plasma from the plasma filter is also reinf...

Страница 77: ...y pressing the key Confirm the message in the Warning window W36 Are you sure to start a new therapy Return to this therapy is not possible with the key to return to the Start screen Please note that...

Страница 78: ...displayed in red The currently selected parameter has a gray background The Setting window displays the allowable range Using the rotary knob select the individual parameters The following parameters...

Страница 79: ...rs are relevant to patient safety can be seen in the Setting window The currently set value is shown above the setting area In addition the LEDs above the key blink To quit the screen for setting the...

Страница 80: ...y selected parameter has a gray background The Setting window displays the allowable range Using the rotary knob you can select the individual parameters The following parameters can be set in the rei...

Страница 81: ...and blood reinfusion volume can be set only in the Main Parameter screen Parameters relevant to patient safety can be seen in the Setting window The currently set value is shown above the setting area...

Страница 82: ...s select the Parameter Setting menu item with the cursor in the Flow Scheme screen and activate it with the key The screen changes to the Setting screen of the Parameter Overview and you can perform h...

Страница 83: ...lood pump with the key Select the Reinfusion Type menu item and press the key The respective submenu is opened Select the Blood Reinfusion menu item in this submenu and confirm it with the key The sub...

Страница 84: ...onal Functions menu item you can select more functions The New Therapy menu item is active only during blood reinfusion It allows for complete termination of the treatment and a return to the Start sc...

Страница 85: ...Operating Manual BASIC SETTINGS Software 2 6 B BRAUN Chapter 7 Page 1 of 4 SHARING EXPERTISE 2 6_CA EN_03 7 BASIC AND DEFAULT SETTINGS...

Страница 86: ...tting window displays the allowable range Using the rotary knob select the individual parameters Press the key to activate the parameter to be changed The field is shown with a red background and whit...

Страница 87: ...ate Plasma This parameter sets the ratio of the dialysate flow in relationship to the plasma flow during the therapy and reinfusion The setting is performed in steps of 1 in the range from 4 to 12 The...

Страница 88: ...In addition the LEDs above the key blink To quit the screen for setting the parameters press the key The cursor changes back to the menu bar of the Service screen If no settings are changed for more...

Страница 89: ...Alarm Concept 8 1 2 List of Alarms 8 2 WARNINGS 8 2 1 Warning Concept 8 2 2 List of Warnings 8 3 PROBLEM CORRECTION 8 3 1 Balance Reset 8 3 2 Deaeration of the Heparin Adsorber 8 3 3 Changing the Solu...

Страница 90: ...ow scheme showing the position e g blinking number for pressure alarms affected by the alarm After correction of the alarm the display automatically changes back to the initial screen If the same alar...

Страница 91: ...lem cannot be solved with a machine restart inform technical service A 03 Deviation of arterial pressure between controller and supervisor Calibration or hardware problems Acknowledge the alarm twice...

Страница 92: ...he machine A 14 Prefilter pressure PBE not zero Consumables already or still mounted Remove all consumables from the machine A 15 Venous pressure PV not zero Consumables already or still mounted Remov...

Страница 93: ...the cause of the alarm and acknowledging the alarm the test is automatically repeated A 28 DAD test failed An error occurred during the DAD check Malfunction of DAD Ensure that The dialysate line is...

Страница 94: ...ous chamber is sufficiently filled If required fill the venous chamber manually A 35 Blood leak detector BLD calibration failed Malfunction of blood leak detector Inform technical service A 36 Blood l...

Страница 95: ...3 The plasma filter is unobstructed and functional Replace the plasma filter if it is obstructed see 8 3 4 If necessary reduce the plasma flow A 45 Maximum plasma pressure PPL Plasma pressure too hig...

Страница 96: ...ssure TMP Transmembrane pressure too high Defective pressure sensors for PV PPL or PBE Ensure that The venous pressure PV is not too high The plasma prefilter pressure PBE is not too high The plasma f...

Страница 97: ...ose the pump cover A 63 Blood pump speed error Wrong speed of blood pump Defective blood pump Ensure that The pump segment is correctly inserted in the blood pump A 64 Plasma buffer pump speed error W...

Страница 98: ...to the inner chamber wall A 74 PPF protector is not connected No pressure change on PPF Ensure that The PPF protector is connected properly Alarms marked with S A 80 A 104 are alarms which are generat...

Страница 99: ...clamped If required reduce the blood flow if the arterial pressure PA is too low If required increase the blood flow if the arterial pressure is too high A 90 S Safety air detector SAD test failed Cal...

Страница 100: ...n Acknowledge the alarm twice If it is not possible switch the machine off and on again to eliminate a possible transient failure If the problem cannot be solved close the treatment immediately and in...

Страница 101: ...s accompanied by acoustic warning tones Warnings which serve to point out a situation are displayed in the Alarm Note field Warnings requiring an action are displayed in a Warning window they must be...

Страница 102: ...ith the key T W 06 Therapy completed The end of the therapy is indicated Press the key to change to the reinfusion phase M W 08 Reinfusion stop for too long Reinfusion interrupted for more than 5 minu...

Страница 103: ...before the start of the therapy Check the positions given on the monitor and confirm with the key to continue M W 16 Press OK to return to menu selection Information for quitting the screen when adju...

Страница 104: ...s and lines The bags are hanging motionless If none of the errors listed above exists stop the therapy or perform a balance reset see 8 3 1 M CAUTION Risk to patient due to impact on the patient s flu...

Страница 105: ...ue therapy M W 41 Open plasma clamp and close venous clamp Confirmation in the middle of blood reinfusion after 150 ml Press the key after opening closing the respective clamps to continue blood reinf...

Страница 106: ...Reason for Warning Corrective Action W 45 W45 Dialysate bags nearly empty Change bags if necessary The dialysate bags are nearly empty since the ratio dialysate plasma is 1 4 and 15 l of dialysate we...

Страница 107: ...e balance error remains and exceeds a value of 300 g the alarm A69 Balance error is initiated and the warning W24 Balance error 300 g check lines and bags displayed Check the system as described above...

Страница 108: ...ient Balance Reset Starting with a balance error 200 g the Balance Reset menu item under Additional Functions can be selected by turning the knob and pressing the key Warning W29 Are you sure to reset...

Страница 109: ...ipitate filter and on the line to the PDF pressure transducer Turn over the heparin adsorber by 180o Press the key of the manual level adjustment of the heparin adsorber air chamber to draw the air ou...

Страница 110: ...e the full drain bags and replace them Attach a clamp to the feeding buffer line Remove the empty acetate buffer bag and replace it by a new prepared acetate buffer bag Open the seal of the new acetat...

Страница 111: ...necessary Remove the full drain bags and replace them Confirm the subsequent message box W 09 Check lines and bags by pressing the key b The remaining amount of dialysate is sufficient for termination...

Страница 112: ...lter and clamp the line on the plasma side Allow the rinse solution to flow by means of gravity into the blood side empty bag Hold the filter so that it is filled from the bottom to the top and thorou...

Страница 113: ...en the filtrate side line when approximately half of the rinse solution has flown into the precipitate side empty bag and clamp shut the precipitate side line Continue to rinse Clamp shut all connecti...

Страница 114: ...mpty bag Hold the adsorber so that it is filled from the bottom to the top and thoroughly vented in the process Clamp shut all connection lines when the remaining rinse solution has flown through be c...

Страница 115: ...rox 1 l rinse solution has flown through be careful that no air enters the filter Switch the machine to bypass mode by selecting Stop Priming or Stop Therapy in the menu bar and confirm with the key C...

Страница 116: ...Service and Maintenance 9 2 4 Disposables Consumables and Accessories Replacement Parts 9 2 5 Cleaning and Disinfection 9 3 TECHNICAL DATA 9 3 1 Technical Data General 9 3 2 Recommended Safe Distance...

Страница 117: ...P Plasmat Futura is tilted by 5 Have 2 or more persons at hand for transporting the machine on stairs and inclined areas Do not tilt the H E L P Plasmat Futura by more than 5 Press the green brake re...

Страница 118: ...a can be held at the base at the handles at the rear panel and at the protrusion at the front of the machine as shown in the illustration below Holding points for carrying the H E L P Plasmat Futura C...

Страница 119: ...9 3 Electrical connection The existing mains voltage must correspond with the voltage specified on the type plate The electrical installation of the room where the machine is installed must comply wit...

Страница 120: ...service personnel who has been authorized by the manufacturer Before the initial start up of the machine check whether it is complete and undamaged If damage is found which endangers the safe operatio...

Страница 121: ...y the manufacturer may be used see Service Manual 9 2 4 Disposables Consumables and Accessories Replacement Parts The machine may be used only in combination with the H E L P apheresis treatment syste...

Страница 122: ...ge current 500 A Patient leakage current 100 A The allowed leakage currents may increase when several machines are connected Operating conditions Operating temperature 15 35 o C Rel humidity 30 90 Atm...

Страница 123: ...0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters with other output power ratings the recommended safe distance d in Meter can be calculated with the above formu...

Страница 124: ...ement range 500 500 mmHg Allowed tolerance 10 mmHg Working range 60 10 mmHg During Therapy Default alarm limits 150 100 mmHg Adjustable in parameter setting Protection system Double channel pressure m...

Страница 125: ...indow can be overridden during Blood Flow change stop Therapy start or PV level regulation till the re stabilization of PV pressure 10 s Acoustic alarm interval 120 s Safety air detector SAD Ultrasoni...

Страница 126: ...PERTISE 2 6_CA EN_03 Heparin pump HP Syringe pump calibrated to Perfusor syringe 30 ml Omnifix Delivery rate 0 10 0 ml h Delivery rate variation 10 Working pressure range 0 250 mmHg Protection system...

Страница 127: ...Therapy Default alarm limits 10 200 mmHg Lower limit adjustable in parameter setting Protection system Sensor test during preparation phase Alarm override Not possible during the therapy Acoustic ala...

Страница 128: ...by a pressure sensor and digitally displayed Measurement range 500 500 mmHg Allowed tolerance 10 mmHg Working range 120 270 mmHg During Therapy Default alarm limits 50 350 mmHg Adjustable in paramete...

Страница 129: ...ble during the therapy Acoustic alarm interval 120 s Dialysate inlet pressure PDI Electronically measured by a pressure sensor and digitally displayed Measurement range 500 500 mmHg Allowed tolerance...

Страница 130: ...t during preparation phase Alarm override Not possible during the therapy Acoustic alarm interval 120 s 9 3 7 Weight System Load cell Loading capacity 30 kg Weight resolution 1 g Linearity 0 015 Worki...

Страница 131: ...ystem Double channel patient balance monitoring with sensor test during preparation phase Alarm override Alarm limit can be increased by 100 g by alarm acknowledge but reaching the alarm limit 400 g o...

Страница 132: ...ectrical installation of the room involved complies with the requirements of VDE 0100 VDE 010 IEC stipulations and the machine is used in accordance with the Operating Manual 9 4 2 Liability and Warra...

Страница 133: ...Operating Manual ANNEX 1 CONSUMABLES Software 2 6 B BRAUN Annex 1 Page 1 of 2 SHARING EXPERTISE 2 6_CA EN_03 ANNEX 1 CONSUMABLES...

Страница 134: ...P precipitate filter 7210932 H E L P ultrafilter SMC 1 8 7061007C Haemoselect L 0 5 plasma filter 7210933 H E L P heparin adsorber 4107 3000 ml H E L P 0 9 NaCl sodium chloride solution 2 bags treatm...

Страница 135: ...Operating Manual ANNEX 2 EXPLANATION OF PRESSURES Software 2 6 B BRAUN Annex 2 Page 1 of 4 SHARING EXPERTISE 2 6_CA EN_03 ANNEX 2 EXPLANATION OF PRESSURES...

Страница 136: ...hase The momentary acquired pressure PBE Ref serves as reference for the calculation of the alarm window Lower limit PBE min PBE Ref 40 mmHg Upper limit PBE max PBE Ref 80 mmHg The lower limit PBE min...

Страница 137: ...he blood flow or after the manual level regulation of the venous or PBE chamber respectively the lower and upper PV limits are automatically adjusted The momentary acquired venous pressure PV Ref serv...

Страница 138: ...f MaxW PVmin MaxW 250 250 Pressure mmHg Priming Therapy fluid side RUN Therapy fluid side STOP Reinfusion fluid side RUN Reinf fluid side STOP Def Def Min Max Def Min Max Def Min Max Def Min Max TMP m...

Страница 139: ...Operating Manual ANNEX 3 LIMIT VALUES Software 2 6 B BRAUN Annex 3 Page 1 of 2 SHARING EXPERTISE 2 6_CA EN_03 ANNEX 3 LIMITS...

Страница 140: ...Plasma 4 4 12 1 Rinsing volume 2400 2400 20000 100 ml Plasma volume 3000 100 6000 50 ml Patient Balance 0 600 0 50 g Temperature 39 34 40 0 5 C Heparin flow 2 0 0 0 10 0 0 5 ml h Heparin bolus 1 0 0...

Страница 141: ...Operating Manual ANNEX 4 SELF TESTS Software 2 6 B BRAUN Annex 4 Page 1 of 7 SHARING EXPERTISE 2 6_CA EN_03 ANNEX 4 SELF TESTS...

Страница 142: ...em in the menu bar and confirming with the key LED Test During the execution of self tests the hardware performs self tests of the LEDs by switching them on intermittently key key key The user must ma...

Страница 143: ...fication whether the controller and the supervisor have the same working state 5 s A02 Arterial pressures of controller and supervisor are identical The arterial pressures PA of the controller and the...

Страница 144: ...id is detected during test 2 s A90 SAD reference test Reference voltage of SAD is tested to be within limit 1 s A94 Running internal communication Correct periodical communication is performed with th...

Страница 145: ...em initiates the alarm situation of a mains failure for 2 s Controller alarm buzzer Continuous alarm tone The control system initiates the buzzer for 2 s Supervisor alarm buzzer Continuous alarm tone...

Страница 146: ...properly into HAK For a duration of 10 s pressure increasing of PDPA must be 60mmHg with a running Plasma pump 30 ml min and closed HAK otherwise alarm A33 will be initiated Before the test or before...

Страница 147: ...same time the absolute difference value between the venous pressure PV and the prefilter pressure PBE is determined which may not be higher than 20 mmHg otherwise alarm A31 will be initiated Step 9 F...

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B. Braun H.E.L.P. Plasmat Futura, Руководство по эксплуатации

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Содержание H.E.L.P. Plasmat Futura

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