B. Braun Aquaboss CCS, Instructions For Use Manual

Page 1: ...Instructions for use CCS Concentrate supply Rev 2 8 Date 2019 02 04 Software version 1 00 Art no LA53591_EN_BAV ...

Page 2: ...Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Instructions Notes on operating instructions ...

Page 3: ...e the system is put into operation In addition they must always be available for reference on site The system operator is obliged to heed the working maintenance and technical safety check processes described in these operating instructions and their respective intervals If these operating instructions are not followed B Braun cannot guarantee safe system operation B Braun reserves the right to al...

Page 4: ...to incorporate your suggestions in subsequent editions Yes I would like to make a suggestion My address is Name Address Tel Fax The item and revision numbers of the operating instructions to hand are as follows Item no Rev My suggestion for improvement concerns the page s My suggestion Please include further pages if necessary You can also include pages you have copied from the operating instructi...

Page 5: ...st aid The operator is to be instructed on the permissible operating data e g setting data for safety and monitoring systems functional tests The operator is to be instructed on system servicing routine check and elimination or irregularities in operation The operator is to be instructed on safe procedures handling the products This includes theoretical principles proper handling and conditions fo...

Page 6: ...ler work step This symbol indicates a cross reference to a chapter within these operating instructions Protective earth connection Ground connection Observe the operating instructions OFF power supply disconnect from mains supply ON power supply connect with mains supply Dangerous voltage Note residual risks Refer to the requirement to obtain safety related information in the user manual The medic...

Page 7: ... conduct the maintenance and safety technical inspections Stoppage of the concentrate supply and therefore no supply and distribution of haemodialysis concentrates possible Non adherence to the manufacturer s maintenance instructions could lead to a functional impact on the system An annual safety inspection STK is prescribed by B Braun authorized experts WARNING Danger of poisoning by released co...

Page 8: ...d technical staff ATTENTION During venting the pressure in the supply line can move above the normal operating pressure To protect any pressure devices connected from possible damage they have to be disconnected before venting ATTENTION Care must be taken that the hydraulic part of the system can be installed under the minimum tank level ATTENTION The CCS is an electrical medical device Special EM...

Page 9: ...ts NOTE The system may only be commissioned by trained and skilled personnel or by a trained representative authorized by B Braun When handling liquid haemodialysis concentrates it is mandatory to refer to the manufacturer s safety provisions NOTE Only original spare parts accessories and consumables from B Braun are to be used Section 2 page 8 1 and Section 1 page 3 1 B Braun does not accept liab...

Page 10: ...Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Instructions Notes on operating instructions ...

Page 11: ...ation with other equipment 5 Return and disposal 6 Function and Modes of Operation 7 Operation 8 System data parameters 9 Faults Causes Correction Section 2 Supplementary Operating Instructions Here you will find the essential instructions for commissioning the system routine check and technical safety system checks 1 Handover declaration for the operating instructions 2 Transport and setup 3 Work...

Page 12: ...Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Instructions Notes on operating instructions ...

Page 13: ...Notes on operating instructions Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Instructions ...

Page 14: ...l safety 1 2 1 4 Residual risks 1 2 1 5 Cleaning 1 2 2 Area of application and intended use 2 1 2 1 Operational features 2 1 2 2 Important performance features 2 1 2 3 Application regulations 2 1 2 4 Contraindications and side effects 2 2 2 4 1 Contraindications 2 2 2 4 2 Side effects 2 2 3 Accessories List 3 1 4 Use in combination with other equipment 4 1 5 Return and disposal 5 1 6 Function and ...

Page 15: ...8 1 Menu structure 8 1 8 2 Langauge menu item 0 8 2 8 3 Entering the date time menu item 1 8 2 8 4 Input of automatic on off menu item 2 8 2 8 5 Container reset menu item 3 8 3 8 6 Pressure alarm reset menu item 4 8 3 8 7 Service interval menu item 5 8 3 8 8 System data menu item 6 8 4 8 8 1 Display of system data menu 6A display 8 4 8 8 2 System data menu 6B Program 8 6 8 9 Maintenance program me...

Page 16: ...onal safety If the product to be processed is damaging to the health contact should be avoided If contact does occur first aid must be carried out on the premises Do not modify remove bypass or bridge safety devices Do not allow the pumps to run dry 1 2 2 Functional safety When the housing is opened Maintenance and repair work may only be carried out by authorized specialists WARNING Hemodialysis ...

Page 17: ...s are potential hazards which are not apparent e g Hazard that could arise from the product or medium such as allergies or skin irritations Hazard arising from faults in the control Hazard arising from misconduct of the operator 1 Electric shock The concentrate supply system CCS is operated with an electric voltage of 100 240 V Improper opening of the control cabinet or damage to the electrical su...

Page 18: ...e ISO 13958 may be pumped Intended use also includes observance of the commissioning operating and maintenance instructions provided by the manufacturer which are an integral part of these instructions The system may only be transported installed used and repaired by skilled workers Commissioning operation and routine check is only to be carried out by authorized trained and instructed skilled wor...

Page 19: ... Instructions 2 4 Contraindications and side effects 2 4 1 Contraindications The CCS may not be used at expired expiry date of the connected concentrate container in case of unclear chemical or microbiological quality of the concentrate if the concentrates to be pumped do not comply with ISO 13958 2 4 2 Side effects Not known ...

Page 20: ...te control 2000300 2 Control CCS Remote control 2000200 3 Process visualisation Basic licence Hardware extension Individual licence CCS 2000100 1050170 2001060 4 Bumper guard 9500206 5 Suction and float lance for barrel operation 93579 ATTENTION The use of other accessories cables or transformers with the CCS device lead to an increase in jamming and a reduction in noise immunity ...

Page 21: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 3 2 CCS Chapter 3 Accessories List Section 1 Operating Instructions ...

Page 22: ...st comply with standard IEC 60601 2 16 equivalent to EN 60601 2 16 Particular requirements for the basic safety and essential performance of haemodialysis haemodiafiltration and haemofiltration equip ment or the first issue of this standard IEC 60601 2 16 ATTENTION The user must ensure that the devices function and are in the proper condition before using the combination of devices ATTENTION It mu...

Page 23: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 4 2 CCS Chapter 4 Use in combination with other equipment Section 1 Operating Instructions ...

Page 24: ...and have to be disposed of in an environ mentally friendly manner The medical product contains a battery Used batteries should be recycled The battery is located on the CPU PCB with display in the front panel and can be lifted off the PCB using a screwdriver Carry out the following steps 1 Set main switch to 0 remove the plug from the mains 2 Change dispose of the battery Battery 1 pc item no 4041...

Page 25: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 5 2 CCS Chapter 5 Return and disposal Section 1 Operating Instructions ...

Page 26: ...value is adapted to the pre set reference value through interaction between a pressure pick up and the capacity of the geared pump in such a way that the pressure deviations in the loop system do not exceed 0 05 bar even when the quantities tapped vary The concentrate supply system CCS has a modular design and can be extended from the basic version 1 concentrate 1 for one floor CCS 1 1 to the maxi...

Page 27: ...concentrate container of the same type At the same time a container replacement request is issued If both supply containers are empty an error message appears on the display The acid concentrate is pumped to the magnet coupled geared pump M1 1 M1 2 M3 2 via a solenoid Y1 1 Y1 2 Y3 2 And from there it is pumped via the actual pressure sensor unit PIS1 1 PIS1 2 PIS3 2 and a non return valve RSV1 1 R...

Page 28: ... is not addressed in good time operation is interrupted immediately and a system fault is signaled max reset time 2 seconds 6 2 Modes of operation 6 2 1 System OFF All outputs are switched off The operation LED is on 6 2 2 Manual mode The system is switched on The automatic program and the remote control input are overridden The operation LED flashes 6 2 3 Automatic mode The system is controlled b...

Page 29: ...om 0 to 100 absolute 6 5 3 Pressure regulator Pressure regulation is carried out for each individual line by means of an adjustable PI regulator see menu 6 12 6 6 Container replacement 1 container is always emptied When a container is empty the system automatically changes to the next container If both containers are empty the system indicates a fault and the respective supply unit is switched off...

Page 30: ...8 Date 2019 02 04 Software version 1 00 CCS Chapter 7 Page 7 1 7 Operation 7 1 Display and keyboard Figure 7 1 Keyboard with 4 line display 1 Display 2 LED red Error Alarm 3 LED green RUN 4 Enter key F4 5 Setting keys F2 F3 6 Menu key F1 5 3 5 1 2 4 6 ...

Page 31: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 7 2 CCS Chapter 7 Operation Section 1 Operating Instructions ...

Page 32: ...perating phase Function keys F1 F2 F3 F4 System off Menu Hand Auto Hand Menu Off Auto Automatic On Off Menu Hand CCS PX X hh mm Lauer Test CCS PX X hh mm Operation mode display Routine check Menu CCS PX X hh mm Operation mode display Battery empty Menu The program branches into the parameter setting level by requesting the program item Menu from the basic control unit state and during opera tion S...

Page 33: ...ng the automatic start of concentrate supply A maximum of 2 automatic start and stop times can be entered for each weekday If the system is to remain in use through 24 00 00 00 h change of day no stop time is given for the first day of operation the stop time is programmed for the 2nd day After automatic mode has finished the control unit automatically switches to the initial operating mode system...

Page 34: ...aller than 0 1 bar for longer than 1 0 second no automatic restart Pressure low active after switch on monitoring malfunction when the actual value is smaller than reference value 0 3 bar for longer than 2 0 minutes no automatic restart Pressure high active after switch on monitoring malfunction when the actual value is greater than reference value 0 2 bar for longer than 1 2 seconds automatic res...

Page 35: ... or entering these by pressing B Program 6 System data 6 A Display 6 B Program Esc Enter Menu items 6 1 6 12 The sub items 6 1 6 2 show the user the current operating values and set control parameters Menu 6 1A to 6 6A The reference and actual pressures and current pump speed are displayed as a percentage value of the permissible maximum speed System type software version Menu item 6 7 verifies th...

Page 36: ...ype SW Date XX XX XXXX Esc 6 8 Routine check XX months Esc 6 9 Hours system XXXXXX hours Esc NOTE The operating hours remain saved even when the EPROM is replaced Economy mode Wherever a solenoid is in economy mode a 1 is indicated Remote on off The switching mode of an assembly to be controlled e g a connected remote control accessories is shown here The remote control input can be pulse or slope...

Page 37: ...an go into economy mode to save energy during the holding phase and to prevent local valve warming Economy mode solenoids on off input range 0 1 Remote control remote on off Input possibilities Pulse trigger slope trigger Positive slope means system on negative slope system off Control parameters To adjust the control parameters of every concentrate line 1 1 3 2 Enter next number Kp Proportional a...

Page 38: ...rmal operating mode is interrupted and all outputs are set to 0 When menu 7 1 is quit a switch on reset is carried out The pumps are operated at 10 of the maximum speed 0 1 Delete set output 7 1 Outputs Enter code XXXX Esc Enter SV Y1 1 0 1 Pump M1 1 0 1 SV Y1 2 0 1 Pump M1 2 0 1 SV Y2 1 0 1 Pump M2 1 0 1 SV Y2 2 0 1 Pump M2 2 0 1 SV Y3 1 0 1 Pump M3 1 0 1 SV Y3 2 0 1 Pump M3 2 0 1 Rel K1 operatio...

Page 39: ...inutes Esc Return to the menu Enter Next venting step 7 3 Venting Enter code XXXX Esc Enter 7 3 Venting Line X X Esc Enter 7 3 Venting X X Pressure X X bar Esc Enter 7 3 Venting X X Time XX min Esc Enter 7 3 Venting X X All systems switched off Esc Enter ATTENTION During venting the pressure in the supply line can move above the normal operating pressure To protect any pressure devices connected f...

Page 40: ...s Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Chapter 8 Page 8 9 8 10 Fault history menu item 8 The last 6 faults to have occurred are displayed including date and time of occurrence 8 Fault history X X Y dd mm jj hh mm X X Y dd mm jj hh mm Esc Enter ...

Page 41: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 8 10 CCS Chapter 8 System data parameters Section 1 Operating Instructions ...

Page 42: ...ates change 2 ERROR A fault has been established The effects could lead to system damage The system is switched off automatically Indicated by System is switched off Fault message display Collective alarm relay Reset by switching the system off and on or via menu depending on the fault 3 MALFUNCTION Malfunction of an individual line The supply line affected is switched off The other lines continue...

Page 43: ...essure fell short of the minimum pressure of 0 1 bar for longer than 1 second Supply line off Reset via menu 4 Alarm reset No Malfunction x x 2 Pressure low Pressure low x x The line pressure is smaller than reference value 0 3 bar for longer than 2 minutes Supply line off Reset via menu 4 Alarm reset No Malfunction x x 3 Pressure high Pressure high x x The line pressure is greater than reference ...

Page 44: ...nd servicing personnel 1 2 1 6 The system was handed over to the customer by 1 2 2 Transport and setup 2 1 2 1 Transport 2 1 2 2 Setup 2 2 2 3 Usage instructions 2 2 3 Work prior to commissioning 3 1 3 1 Requirements at the place of installation 3 1 3 2 On site connections to media supply 3 1 3 2 1 Electrical connection 3 1 3 2 2 Hydraulic connection 3 1 3 3 Setup and alignment of the system 3 1 3...

Page 45: ... Operating Instructions 6 Technical data 6 1 6 1 Specifications 6 1 6 2 Serial interface 6 2 6 2 1 Data format 6 2 6 2 2 Connection diagram 6 2 6 2 3 EMC guidelines 6 3 7 Medical product log Aquaboss CCS 7 1 Maintenance plan and technical safety check CCS 7 3 8 Spare parts list CCS 8 1 ...

Page 46: ...ntrate Supply CCS CCS system Serial number Year month of manufacture 1 2 Customer s address Company Street Postal code city 1 3 Confirmation of handover of operating instructions We have purchased the system specified under section 1 1 Together with the system we were also given the operating instructions for System number in the languages Quantity Quantity Company stamp Customer name block letter...

Page 47: ...r and have been instructed and trained on the system by B Braun and made aware of the following points protective equipment dangerous areas inadmissible operation set up operation routine check and repair Name customer staff Signature Name customer staff Signature Name customer staff Signature B Braun commissioning log Customer specific commissioning log Company stamp Customer s signature 1 6 The ...

Page 48: ... The system must be protected from humidity soiling and extreme temperatures during transport and storage The system must not be exposed to rain The system must not be operated in a damp or wet environment In addition operation of the device in the presence of explosive gases and combustible liquids gases is prohibited The CCS must be stored in its original packaging in warm dry and dust free room...

Page 49: ...net is mounted on the wall The design of the control cabinet display makes it easy to read off when it is mounted at about eye level 2 3 Usage instructions The dialysis concentrates available must meet the requirements for the purpose of application Please heed the product specifications Any other use or use beyond the purpose named is not considered use in line with the device s purpose The manuf...

Page 50: ...ly via the system plug Heed on site fuse protection according to requirements VDE Socket protected by FI 30mA 3 2 2 Hydraulic connection Before commissioning the following work must be carried out by the customer a service technician Set up and alignment of the system Installation of the electrical connection Installation of hydraulic connection Initial commissioning incl language selection in the...

Page 51: ...ed LEDs 3 5 Hydraulic connection The hydraulic connection on the concentrate tank or two tanks depending on concentrate locations is via a CPC coupling hose ø 19 mm on the sides of the hydraulic part A flexible hose of the nominal size 8 mm is used to connect the concentrate loop to the top of the device In addition the tank level displays must be connected via CPC couplings NOTE Initial system sw...

Page 52: ... the system must be switched on using the main switch 1 and the language selected accordingly under the sub menu 0 Language The menu is quit again by pressing the Esc key 4 2 System parameters Then the set system parameters must be adapted to local conditions and logged Figure 4 1 Switch cabinet drilling pattern NOTE The system may only be commissioned by trained and skilled personnel or by a trai...

Page 53: ...ssioning Section 2 Operating Instructions Figure 4 2 Switch cabinet drilling pattern 4 3 Logging commissioning After initial start up of the system has been carried out the log must be completed and signed by those involved see the form depicted on the folloiwng pages View from below ...

Page 54: ...__________ ________________________ Fluid Unit 1 serial number ________________________ ________________________ Fluid Unit 2 serial number ________________________ ________________________ Fluid Unit 3 serial number ________________________ ________________________ Switch cabinet yes no Remark Assembled acc to layout plan ________________________ Free of scratches and damage _____________________...

Page 55: ...to concentrate containers inserted and leak free Fluid Unit 1 Fluid Unit 2 Fluid Unit 3 Venting pipe inserted and closed with sterile filter Level in sight glass with fluid at rest corresponds to container filling level Fluid Unit 1 Fluid Unit 2 Fluid Unit 3 NOTE The loop connected has been checked for leaks and undergone a pressure test Log ext The loop connected has been checked for continuity f...

Page 56: ...ntrol parameters Carried out OK Reference value Actual value Values data remarks Proportional amplification Kp ________ _______ Integration time constant Ki ________ _______ Speed range of pumps min max M2 1 2 _________ ________ Recording control parameters Carried out OK Reference value Actual value Values data remarks Proportional amplification Kp ________ _______ Integration time constant Ki __...

Page 57: ...max M5 3 1 _________ ________ Recording control parameters Carried out OK Reference value Actual value Values data remarks Proportional amplification Kp ________ _______ Integration time constant Ki ________ _______ Speed range of pumps min max M6 3 2 _________ ________ Pressures in the individual lines Carried out OK Values data remarks Dialysis operation line 1 1 Dialysis operation line 1 2 Dial...

Page 58: ...OK not OK Line 3 2 OK not OK OK not OK Protective conductor resistor electr safety DIN EN 61010 1 test equipment number Carried out OK Values data remarks NR R V Measured value Limit value Measurement betw connection cable and housing RSL 0 1 X Measurement betw connection cable and mounting plate RSL 0 1 X Measurement betw connection cable and doors front panel RSL 0 1 X Measurement between connec...

Page 59: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 4 8 CCS Chapter 4 Initial commissioning Section 2 Operating Instructions ...

Page 60: ... reserved ISO 13485 certified CE mark CE 0123 Made in Germany EU Type plate The type plate is on the left hand side of the switch cabinet Figure 5 1 Example of a type plate When ordering spare parts please provide the following information System type Serial number SN Designation and item number Required quantity NOTE Only original spare parts accessories and consumables from B Braun are to be use...

Page 61: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 5 2 CCS Chapter 5 System key data Section 2 Operating Instructions ...

Page 62: ...id valves 1 2 2 4 3 6 Power consumption valves 24V R 19 19 38 38 57 57 Control for max 3 FU prim 1 100 240V 50 60Hz Sec 24V DC R 46 Overall consumption CCS KVA max 0 97 Fuse protection for power protection switch A 10 Collective output Two way contact pot free External control NO contact pot free Connection inlet DN 19 Connection concentrate feed flow DN 8 Connection concentrate return flow DN 8 C...

Page 63: ...at Baud rate 1200bit s Parity none Bit character 8 No of start bits 1 No of stop bits 1 6 2 2 Connection diagram 1 2 3 4 5 6 7 8 9 DCD RxD TxD DTR GND DSR RTS CTS DSR CPU RO ECORO 1 2 3 4 5 6 7 8 9 DCD RxD TxD DTR GND DSR RTS CTS DSR PC DSUB 9pol DSUB 9pol 10 DCD RxD TxD DTR GND DSR RTS CTS DSR VCC 1 2 3 4 5 6 7 8 9 FB 10pol Interface converter IF232LP ...

Page 64: ...charge 8 kV Contact discharge 2kV 4kV 8kV 15kV Air discharge Floors should be made of wood or concrete or have ceramic tiles If the floor covering is made of synthetic material the relative humidity must be at least 30 Fast transient electrical emissions bursts according to IEC 610004 4 2 kV for mains cables 1 kV for input and output cables Burst 100 kHz 2 kV for mains cables 1 kV for input and ou...

Page 65: ...990 MHz 50 PM 217 Hz 28 V m 1700 1990 MHz 50 PM 217 Hz GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS max 2 W 28 V m 2400 2570 MHz 50 PM 217 Hz 28 V m 2400 2570 MHz 50 PM 217 Hz Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 max 2 W 9 V m 5100 5800 50 PM 217 Hz 9 V m 5100 5800 50 PM 217 Hz WLAN 802 11 a n max 0 2 W For all frequencies the field strength of stationary radio transmitters ...

Page 66: ... 2 6 3 100 20 10 20 In the case of transmitters whose maximum nominal power is not listed in the table above the recommended electrical clearance of d in meters m can be determined using the equation that belongs in the respective column whereby P is the maximum electrical clearance in Watts W according to the information provided by the transmitter manufacturer ܧ ൌ ξܲ NOTE 1 The higher frequency ...

Page 67: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 6 6 CCS Chapter 6 Technical data Section 2 Operating Instructions ...

Page 68: ...ave been instructed and trained on the system by B Braun and made aware of the following points protective equipment dangerous areas inadmissible operation setup operation servicing and plant maintenance Servicing work is usually carried out every six months The technical safety checks STK must be carried out once a year by B Braun or skilled workers author ized by B Braun MPBetreibV Name customer...

Page 69: ...alysis concentrates possible Non adherence to the manufacturer s maintenance instructions could lead to a functional impact on the system An annual safety inspection STK is prescribed by B Braun authorized experts WARNING Danger of poisoning by released construction materials and hazard to patients due to system failure After maintenance repair exchange of components or other changes the operator ...

Page 70: ...lues date remarks degree of soiling R V 1 1 System connections to the hydraulic parts X X 1 2 Venting and filling level equipment X X 1 3 Sterile filters on venting and filling level equipment X X 1 4 Supply tanks for hydraulic parts X X 1 5 Pumps X X 1 6 Solenoid valves X X 1 7 Visible damage housing mains cable display X X 1 8 Accessories wearing parts identification evaluation available X X 1 9...

Page 71: ...ation line 3 1 3 2 X X 5 Check measuring transducers at maximum rpm and manometer Carried out OK Display bar Actual bar Values data remarks R V 5 1 PIS 1 1 1 2 X 5 2 PIS 2 1 2 2 X 5 3 PIS 3 1 3 2 X 6 Check ring for continuity Carried out OK Left Right Values data remarks R V 6 1 Line 1 1 1 2 OK n OK OK n OK X 6 2 Line 2 1 2 2 OK n OK OK n OK X 6 3 Line 3 1 3 2 OK n OK OK n OK X 7 Fault history Che...

Page 72: ... accordance with DIN EN 62353 IEC 62353 Values data remarks W V Test equipment number Test executed in accordance with DIN EN 62353 IEC 62353 13 1 Visual inspection Mains connection cable complete system OK n OK 13 2 Protective conductor resistance Measured value Limit value 13 3 Measurement between mains connection cable and housing RSL 0 300 X 13 4 Measurement between mains connection cable and ...

Page 73: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 7 6 CCS Chapter 7 Medical product log Aquaboss CCS Section 2 Operating Instructions ...

Page 74: ...t CCS Section 2 Operating Instructions Rev 2 8 Date 2019 02 04 Software version 1 00 CCS Chapter 8 Page 8 1 8 Spare parts list CCS A detailed spare parts list is included in the scope of delivery for the system TM 44 ...

Page 75: ...Rev 2 8 Date 2019 02 04 Software version 1 00 Page 8 2 CCS Chapter 8 Spare parts list CCS Section 2 Operating Instructions ...