Irrigation Pump User Manual - STOCKERT medical solutions
Contents
1. or There is a communication problem with the SMARTABLATE RF Generator There is a problem with the connection cable from the generator to the pump There is a problem with the foot pedal The internal battery has low voltage 6 Troubleshooting Page 19 What To Do Release the Stop button If the warning does not disappear contact Customer Support Release the pressed button s If the warning does not disappear contact Customer Support If two pumps are connected both pumps will go into low standby flow Disconnect one pump from the generator If only one pump is connected disconnect the pump connection cable from the generator reconnect it and wait 5 seconds If the warning occurs again replace the connection cable with a new cable If the problem persists operate the pump using the pump user interface and contact Customer Support Disconnect the cable and reconnect it or turn the pump off and on If the problem persists operate the pump using the pump user interface or the foot pedal and contact Customer Support Disconnect the foot pedal and reconnect it or turn the pump off and on If the problem persists operate the pump using the pump user interface or the generator interface and contact Customer Support Contact Customer Support Irrigation Pump User Manual 6 2 Errors Each error situation generates an alarm see Section 7 9 Alarm Specifications Al2. EMISSIONS or decreased IMMUNITY of the SmarTABLATE Irrigation Pump Warning The SMARTABLATE Irrigation Pump may be operated in the immediate vicinity of the SmarTABLATE RF Generator However do not operate the pump in the immediate vicinity of devices that are not approved for electromagnetic compatibility EMC with the pump If such operation is unavoidable regularly monitor the pump to ensure proper functioning Warning The SMARTABLATE Irrigation Pump may be interfered with by other equipment even if that other equipment complies with CISPR EMISSION requirements 7 Technical Data Page 29 Irrigation Pump User Manual SMART The following instructions must be followed to avoid disturbance of the measurement quality e The SmarTABLATE Irrigation Pump may be operated only with cables specified by the manufacturer e The SmartAsLaTe Irrigation Pump must be connected with the grounding cable to a separate grounding point e All devices in the patient area that are connected to the SmarRTABLATE Irrigation Pump must be on the same mains e All devices in the patient area that are connected to the SmarTABLATE Irrigation Pump must be connected to separate ground points with their own grounding cables 7 9 Alarm Specifications After an alarm event occurs there may be a delay of not more than 500 ms before the related sound light and or message are produced Al Alarm Indicator see Item 7 in Sec
3. Alarm Indicator see Item 7 in Section 3 1 Controls on the Front of the Pump BI Bubble Indicator see Item 16 in Section 3 1 Controls on the Front of the Pump Image Al BI Message Reason Blinks Blinks Big A big bubble was red red bubble detected during high ablation or low standby flow Blinks Blinks Many Many small bubbles red red small were detected during bubbles high ablation or low standby flow What To Do Patient danger Immediately turn the 4 way stopcock on the SMARTABLATE Irrigation Tubing Set so that the fluid is not routed to the catheter Then press the Stop button on the pump Be sure to clear the bubble before starting the flow even if the error message disappears See Section 5 3 Flushing to Eliminate Air in the Tubing and Catheter Note Opening the door can move the tubing slightly causing the bubbles to move out of the bubble sensor area Inspect the tubing carefully I Patient danger Immediately turn the 4 way stopcock on the SMARTABLATE Irrigation Tubing Set so that the fluid is not routed to the catheter Then press the Stop button on the pump Be sure to clear the bubbles before Starting the flow even if the error message disappears See Section 5 3 Flushing to Eliminate Air in the Tubing and Catheter Note Opening the door can move the tubing slightly causing the bubbles to move out of the bubble sensor area Inspect the tubing carefully 6 Tr
4. Class 3 FDA Weight 5 5 kg Dimensions 195 mm wide x 180 mm high x 235 mm long IP rating IP54 7 Technical Data Page 23 Irrigation Pump User Manual 7 2 Storage and Shipping Conditions Ambient temperature 30 to 65 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060 mbar 7 3 Operating Conditions Ambient temperature 10 to 40 C Relative humidity 10 to 90 non condensing Atmospheric pressure 700 to 1060 mbar 7 4 Safety Inspections N Important Notice To ensure the safety of the SMARTABLATE Irrigation Pump repairs and safety inspections may be performed only by the manufacturer a service engineer certified by the manufacturer or a service center certified by the manufacturer The safety inspections must be performed at least once a year and after every repair according to IEC EN 60601 1 and its sub standards and IEC EN 62353 7 5 Maintenance Inspect the pump before each use Perform the following verifications e The High Ablation Flow and Low Standby Flow knobs are not loose and the values on the screen change as expected when the knob is turned e None of the receptacles is damaged or loose e The potential equalization port is not damaged and is not loose e The mains cable is not damaged e The foot pedal is not damaged Once a year perform the verifications listed above as well as those listed below e The device label is present and readable e The foot
5. The SmarTABLaTe Irrigation Pump was calibrated by the manufacturer Changing pump settings other than those described in Chapter 5 Pump Operation will result in improper functioning and will void the warranty If fluid penetrates into the pump stop using the pump and contact Customer Support Use the SmarTABLATE Irrigation Pump only in combination with the SmarTABLATE Irrigation Tubing Set If unsuitable tubing is used the pump will not function properly and improper irrigation will result The sterile SMaRTABLATE Irrigation Tubing Set is intended for one time patient use To avoid biological contamination and ensure proper functioning do not reuse or resterilize the tubing set The SMARTABLATE Irrigation Pump monitors the flow of irrigation solution If there is a problem with the solution flow the pump stops the flow and issues an alarm Correct alarm situations and restart the flow as quickly as possible The hospital staff is responsible for ensuring that the pump is functioning properly and that the solutions and irrigated catheters that are used in the overall irrigation process are compatible with each other The SMARTABLATE Irrigation Pump and the SMARTABLATE Irrigation Tubing Set are intended for use with a standard irrigation solution such as a normal isotonic saline solution The precision of the flow rate stated in the technical data may not be maintained if incompatible fluids and or incompatible irrigated c
6. peristaltic pump designed to work in conjunction with the SMARTABLATE RF Generator to deliver irrigation solution at specified flow rates to irrigated catheters such as the Biosense Webster CELsius THERMOCOOL Catheters and NaviStar THERMOCOOL Catheters for cooling purposes The pump is used with the SmarTABLATE Irrigation Tubing Set that conducts the irrigation solution from an external source to the compatible irrigated catheters The SmarTABLATE Irrigation Pump was designed to allow simple intuitive and user friendly operation When connected to the SmarTABLate RF Generator by the supplied interface cable the pump can be controlled directly from the user interface of the generator Simultaneously the pump transfers status information regarding solution flow rates back to the SMARTABLATE RF Generator to allow safe operation If an error occurs in either of these devices the necessary notification and recovery steps are initiated simultaneously in both devices The pump can be operated directly from the pump user interface when it is not connected to the SMARTABLATE RF Generator Use of the SmarTABLaTE Irrigation Pump requires familiarity with the device and its operation The user should read this manual which describes how to operate the SMARTABLATE Irrigation Pump and should attend a presentation on the operation and configuration of the pump provided by Biosense Webster The user should also become familiar
7. ti ti ti ti ti ti ti ti Tone frequency 910 Hz 20 Tone pause 10 s Pulse pattern ti ti ti ti ti ti ti ti ti ti Tone frequency 910 Hz 20 Tone pause 10 s Pulse pattern ti ti ti ti ti ti ti ti ti ti Tone frequency 910 Hz 20 Tone pause 10 s Pulse pattern ti ti ti ti ti ti ti ti ti ti Tone frequency 910 Hz 20 Tone pause 10 s Pulse pattern ti ti ti ti ti ti ti ti ti ti Tone frequency 910 Hz 20 Tone pause 10 s Note All alarms are technical alarms Al On red Blinks red 2Hz 40 on 20 Blinks red 2HZz 40 on 20 Blinks red 2Hz 40 on 20 Blinks red 2Hz 40 on 20 Blinks red 2Hz 40 on 20 7 Technical Data Page 31 BI Off Blinks red 2Hz 40 on 20 Blinks red 2Hz 40 on 20 Off Off Off Reset Action Close door Press Stop button Press Stop button none none none Comments Information alarm High priority alarm High priority alarm High priority alarm High priority alarm High priority alarm Irrigation Pump User Manual 8 Symbols Symbol Oe A i 0 O 5 amaran atE Sonat Aaen Distributed by Manufactured by Description SMARTABLATE Irrigation Pump The device is distributed by The device is manufactured by Quantity Follow o
8. ATE Irrigation Pump Radio interference and electromagnetic fields can trigger false alarms and malfunctions in electrical units such as the SmarTABLATE Irrigation Pump Furthermore use of electrical units such as this pump can occasionally result in wrong values on ECG monitors that are not operated under optimal conditions Although the pump is designed to avoid such interference when the pump is used with electromagnetic navigation systems and ECG monitors verify correct operation of the connected devices before use on a patient If interference occurs move the pump to another location If error messages repeatedly appear stop using the pump and contact Customer Support To avoid damage to the pump and its accessories use only appropriate cleaning agents see Section 3 12 Cleaning and Disinfecting the Pump There are no parts in the SMARTABLATE Irrigation Pump that may be serviced by the user Exception The fuses may be replaced per Section 3 6 Fuses 2 Warnings Page 2 Irrigation Pump User Manual 12 13 14 15 16 17 18 19 20 21 22 23 24 The pump enclosure may be opened only by persons authorized by the manufacturer When the pump enclosure is open parts that have high voltage or are very hot are accessible and can cause injury If the pump enclosure is opened by an unauthorized person any claims on the warranty are void No modification of the pump is permitted
9. IONS Sound volume Button brightness English Service Battery Serial number Serial number Version Software version a Manufacturing date Turn off the pump and close the pump door Press and hold the Low Standby Flow button while you briefly press the Stand by button Release the Low Standby Flow button when the Options screen appears displaying the serial number and software version Press the Stand by button to remove the information from the screen The pump will turn off 6 Troubleshooting Page 22 Irrigation Pump User Manual 7 Technical Data 7 1 Specifications Mains Voltage 100 120 V 10 220 230 V 10 Frequency 50 60 Hz Power consumption 30 VA Mode of Operation Continuous operation Flow Accuracy up to 75 psi 1 mL min 20 to 20 2 5 mL min 10 to 20 6 39 mL min 5 to 15 40 60 mL min 10 to 20 Flush 100 mL min 10 to 20 Bubble Detection Designed to detect bubbles gt 2 uL Adjustment of the Flow Rates in 1 mL min steps Low Standby Flow 1 mL min 5 mL min High Ablation Flow 6 mL min 30 mL min versions US and JP 6 mL min 60 mL min version WW Maximum Infusion Pressure 115 psi Sound Pressure Level for Error Messages 45 to 65 dB A measured 1 m from pump Fuses T500 mAH 250V Other Classifications Class and defibrillation proof type CF as defined in IEC EN 60601 1 Class lla as defined in MDD 93 42 EEC
10. ShA aii Irrigation Pump User Manual SAP_UM_04 00_EN Manufactured by Distributed by Stockert GmbH K Biosense Webster a fofmonafolmon company Irrigation Pump User Manual Table of Contents PREFACE II 1 INDICATIONS 1 2 WARNINGS 2 3 PUMP SETUP 5 3 1 Controls on the Front of the PUMP cs coc ccsceccsecesccescsssewsecaesceszcesescetsnacencsvassesesdesciaserastetechascieesdaeceamenes 5 3 2 Controls on the Back of the PUMP sessesssessessesseessessesseessesseessesseoseesenseoseeseesseoseoseeseeeseesseoseoseeeesseesees 6 3 3 Diagram of the Pump with the SmartABLAaTE RF Generator and ACCESSOTLICS ecsccceseees 7 34 MUTI OC AE Oia cass secaspesccassececcozesastucsesnevedeensat oce sess asenenesuectouasasas vonsoatecassscateotaspecesnesstscsueai toniavtenstavenesaiotel 8 39 Mains INCOM rece sccecacancysoceatcae eonceaecotacesnesencahtcsaccaveoptucss vssvsutechtusscsersuatusas esesuctuesseacoaceccebeedntectearsneetas 8 Bi FG SS E E EE E A EE 8 SF Girc lar Plug COnnectioN Sson aa EEE Eas 8 3 8 Potential Equalization eessessessesseseessessessessessessessessessessesseseeseeuseeseoseosessessevsesseveeseeeeseeseeseesseseseeseeseeseese 9 3 9 Foot Pedal Connection s ssesseessessesssesseeseessesseeseesesseoseeseesseoseosseoseeseesseoseoseeseesseoseoseessesseosseoseoseessesseosees 9 3 10 Connection to the RF Generator esecesstescitscertesssstcoeva sxc tsvosss osnncewtacssescunsscessttsatenteeeriewnesueseneasthtstdseiss 9 3 11 Adj
11. an SMARTABLATE Irrigation Pump Firmware 1 XX Biosense Webster Inc 2012 2013 January 2013 SAP_UM_04 00_EN
12. atheters are used The SmarTABLATE Irrigation Pump may be operated in the immediate vicinity of the SMARTABLATE RF Generator However do not operate the pump in the immediate vicinity of devices that are not approved for electromagnetic compatibility EMC with the pump If such operation is unavoidable regularly monitor the pump to ensure proper functioning Do not connect the SmarTABLATE Irrigation Pump to other infusion systems including gravity intravenous IV infusion systems To prevent explosions do not use the pump near explosive anesthetics To prevent electric shock and fires do not expose the pump to excessive humidity To avoid the risk of electric shock connect the pump to a 3 prong mains outlet that meets the specifications in Section 7 1 Specifications Parts such as the intravenous IV pole clamp the rotating pump head and the door that covers the pump head are designed for safe operation but must be used with caution 2 Warnings Page 3 Irrigation Pump User Manual 25 26 2 28 29 30 31 32 33 The SmaRTABLATE Irrigation Pump is intended for use with irrigated catheters Monitor the irrigation flow rate to avoid hazards caused by insufficient irrigation flow Monitoring the flow rate on the pump display alone is not sufficient because the flow rate is calculated from the pump motor speed If the pump fails to rotate at the speed set by the user the pump issues an a
13. ctrical and electronic equipment WEEE Directive 2006 66 EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91 157 EEC Analysis techniques for system reliability Procedure for failure mode and effects analysis FMEA Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral Standard Programmable electrical medical systems Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral Standard Requirements for environmentally conscious d
14. e from SMARTABLATE RF Generator to SMARTABLATE Irrigation Pump Redel 10 gt Redel 10 blue length 1 m M490027 length 3 m M490016 length 5 m M490028 length 10 m M490030 I 4 Accessories Page 12 Irrigation Pump User Manual Mains Cable length 3 m Australia M4900601 Brazil M4900609 China M4900410 EU M4900108 r India South Africa M4900604 Israel M4900606 4 fe Japan M4900210 Russia M4900603 Switzerland M4900605 1 AE Taiwan M4900607 UK Singapore Hong Kong M4900602 USA M490024 Grounding Cable length 3 m Worldwide except Japan M490014 Pe Japan M490015 LGD 4 3 Other Accessories or tA i mA SMARTABLATE Irrigation Tubing Set SATOO1 SMARTABLATE Irrigation Pump Intravenous M490037 IV Pole Clamp 4 Accessories Page 13 Irrigation Pump User Manual 5 Pump Operation Read this entire user manual before operating the SMARTABLATE Irrigation Pump The instructions in this chapter describe how to operate the SMARTABLATE Irrigation Pump using the pump s user interface However the pump can also be operated including setting flow rates using the SMARTABLATE RF Generator user interface see Section 5 8 Communication with the SMARTABLATE RF Generator and see the instructions in the user manual for the generator 5 1 Turning the Pump On and Off To turn the pump on press the Stand by button The SmartTABLATE System logo appears on the sc
15. esign 7 Technical Data Page 25 Irrigation Pump User Manual Standard Title IEC EN 62304 Medical device software Software life cycle processes IEC EN 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment IEC EN 62366 Medical devices Application of usability engineering to medical devices MDD 93 42 EEC Medical Device Directive MDD Council Directive 93 42 EEC of 14 June 1993 MPG Medical concerning medical devices Products Law UL 60601 1 Medical electrical equipment Part 1 General requirements for safety 7 8 EMC Information and Technical Description The use of accessories transducers and cables other than those specified with the exception of transducers and cables approved by the manufacturer of the SmarTABLATE Irrigation Pump as replacement parts for internal components may result in increased emissions or decreased immunity of the SMaRTABLATE Irrigation Pump Electromagnetic Emissions The SMARTABLATE Irrigation Pump is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Irrigation Pump should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The SmarTABLATE Irrigation Pump uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any inte
16. force until a click indicates that the connector is locked in the receptacle If the plug does not fit in the receptacle verify that the color coding matches and that the number of pins in the plug is appropriate for the receptacle To remove a circular plug gently pull back the sleeve on the plug and pull the plug out of the receptacle 3 Pump Setup Page 8 Irrigation Pump User Manual 3 8 3 9 3 10 Potential Equalization To avoid differences in potential between the pump and other devices with power operation the SmarRTABLATE Irrigation Pump must be connected to a grounding line as specified in IEC EN 60601 1 Connect one end of the green and yellow potential equalization cable provided with the pump to the grounding connection on the back of the pump see Item 24 in Section 3 2 Controls on the Back of the Pump Connect the other end to the room s central grounding line To avoid radiation interference noise in the ECG signal always use the same grounding line for connection of all devices involved electrocardiograph Carto System generator Foot Pedal Connection See Section 3 7 Circular Plug Connections Connection to the RF Generator Turn on the RF generator and the SMARTABLATE Irrigation Pump see Section 5 1 Turning the Pump On and Off Plug the connection cable from the RF generator into the COMM 1 receptacle on the back of the pump as described in Section 3 7 Circular Plug Connections F
17. h individually and together as specified in IEC EN 60601 1 and its sub standards and IEC EN 60601 1 2 Do not put any labels or stickers on the front of the pump that will obscure the buttons or indicator lights The pump should be used only when the use of irrigation solution is appropriate relative to the medical condition of the patient If it is not known what influence irrigation solution might have on a patient consult with appropriate medical professionals before using this device When the pump is used alone for an ablation procedure without being controlled by an RF generator high flow of the irrigation solution should be started before the RF energy is turned on to allow the desired flow rate to be reached at the tip of the catheter High flow should be continued for a few seconds after the RF energy is turned off in order to avoid thrombus formation on the ablation electrode 2 Warnings Page 4 Irrigation Pump User Manual 3 Pump Setup 3 1 Controls on the Front of the Pump 10 11 12 mL min gt LOW N 4 SMARTABLATE sverTam Manufactured by Stockert GmbH Distributed by 4 Biosense Webster a foharen folen company Item Description 1 Pump head pressure plate 2 Pump head 3 Flush button 4 Stand by button 5 Stand by indicator 6 Stop button 7 Alarm indicator 8 Active flow rate 9 Selected high ablation flow rate 10 Selected low standby flow rate 11 High Ablati
18. halates The device is latex free The device may be damaged by electrostatic discharge ESD if a person without ESD protection touches a COMM receptacle Do not touch without appropriate ESD protection The device is protected against dust and is protected against splashing water Hardware revision number 8 Symbols Page 33 Irrigation Pump User Manual 9 Warranty 9 1 Transit Damage The SMARTABLATE Irrigation Pump and accessories must be examined for transit damage immediately after receipt If the pump and accessories are damaged notify Customer Support Damage claims can be validated only if the seller or the shipping agent is informed immediately For your convenience an Error Report form is shipped with the pump you can use this form to record any damage 9 2 Warranty The warranty for the SmarTABLaATE Irrigation Pump warrants that the pump will conform to its product specifications for a period of one year from the date of shipment or for the period of time defined in the purchase contract Exceptions to the warranty are accessories connection cables and disposable parts Repairs or any changes may be performed only by the manufacturer a service engineer authorized by the manufacturer or a service center authorized by the manufacturer The warranty is voided if improper modifications or repairs are performed The warranty is not extended or renewed by services performed under warranty 9 3 Product Liabilit
19. he Pump Image Al BI Blinks Off red Message varies Reason There is a system error What To Do If you see this image with any message that is not listed in Section 6 2 Errors turn the pump off and on If the error persists contact Customer Support 6 Troubleshooting Page 21 Irrigation Pump User Manual 6 4 Other Troubleshooting Problem What To Do The pump will not turn on Verify that the power supply meets the specifications in Section 7 1 Specifications and then check to see whether a fuse is broken If a fuse is broken replace it see Section 3 6 Fuses If the fuse is not broken or if a new fuse breaks call Customer Support On startup the SMARTABLATE Press and hold the Stand by button for approximately 3 seconds to System logo does not appear turn off the pump Then press the Stand by button again to turn the the alarm and air bubble pump back on If the problem persists contact Customer Support indicators do not light or there is no audible tone The pump turns on when you The pump turns on automatically if it is connected to the don t want it on SMARTABLATE RF Generator and the generator is turned on Press the Stand by button on the pump to put the pump into sleep mode see Section 5 1 Turning the Pump On and Off 6 5 Determining the Pump s Serial Number and Software Version Customer Support may ask for the pump s serial number and software version Options Screen OPT
20. he pump s screen If damp cleaning is necessary moisten a soft cotton or linen cloth with commercial grade glass cleaner that does not contain alcohol and wipe the screen Do not spray the cleaner directly onto the screen Use a soft damp lint free cloth to clean and disinfect the housing of the pump Use only non flammable and non explosive substances Water or soapy water is recommended for cleaning Make sure that no liquid penetrates the inside of the pump The following disinfectants can be used for disinfecting the pump and its cables e Lysoformin spezial e Kodan e Meliseptol e Commercial disinfectants that do not contain ethyl alcohol Caution The following substances must not be used acetone benzene acids of any kind including acetic acid and citric acid scouring agents nitro dilutions and other organic solvents Do not use any agent containing ethyl alcohol to clean the pump lodine or disinfectants containing dyes cause discoloration of the housing and should not be used Perform disinfection by wiping not spraying Avoid condensation If cleaning or disinfecting the pump with flammable or explosive substances cannot be avoided make sure these substances have completely evaporated before the pump is turned on 3 13 Protecting against Damage In addition to being operated and maintained per the instructions in this user manual the SMARTABLATE Irrigation Pump must also be protected against damage This include
21. larm However because it is possible for a situation to arise during which the motor head is rotating but there is no flow it is important to repeatedly monitor the approximate flow rate by observing the drip speed in the drip chamber The drip chamber should be half to three quarters filled to ensure no bubbles enter the tubing and provide visibility of the drip speed The hospital staff is responsible for determining and monitoring the flow rate to avoid insufficient flow of the irrigation solution The hospital staff is responsible for monitoring the total amount of solution delivered to the patient to avoid an excessive loading of the irrigation solution in the patient For recommended flow rates refer to the catheter s instructions for use The person who connects the devices and accessories to each other or who uses the devices and accessories is responsible and liable for installation and operation that complies with IEC EN 60601 1 1 All system components must comply with all applicable requirements and standards and must be labeled pursuant to these standards If there are any concerns regarding the use of a component contact the distributor of the component to obtain further information The pump the generator and all accessories connected to the pump or generator when located within the patient area must comply with IEC EN 60601 1 and its sub standards If several devices are connected to each other they should be as safe bot
22. le To completely cut off power to the pump disconnect the mains cable from the pump To allow easy disconnection in the event of severe power failure make sure that the pump is located where there is easy access to the mains cable After turning on the pump always wait until the automatic self test has been successfully completed before starting the first steps of the procedure on the patient for example before anesthesia or before creating percutaneous access Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient s health Use only accessories that have been provided by or recommended by the pump s manufacturer see Chapter 4 Accessories The use of other accessories can have a negative effect on the technical specifications Do not modify accessories Visually inspect all accessories on a regular basis Make sure that the connected cables are not damaged When using sterile accessories be sure to maintain the sterility of those accessories Inspect the pump for damage before each use see Section 7 5 Maintenance Special safety measures with regard to electromagnetic compatibility EMC must be taken with electrical medical devices Portable and mobile communication devices may cause harmful interference to the functioning of the pump Do not use portable or mobile communication devices in the vicinity of the SMARTABL
23. mation only Opening the door during motor rotation stops the pump I Patient danger Immediately turn the 4 way stopcock on the SMARTABLATE Irrigation Tubing Set so that the fluid is not routed to the catheter Be sure to clear the bubble before starting the flow even if the warning message disappears see Section 5 3 Flushing to Eliminate Air in the Tubing and Catheter Note Opening the door can move the tubing slightly causing the bubbles to move out of the bubble sensor area Inspect the tubing carefully Release the gt low standby flow button If the warning does not disappear contact Customer Support Release the gt gt high ablation flow button If the warning does not disappear contact Customer Support Release the gt gt gt flush flow button If the warning does not disappear contact Customer Support 6 Troubleshooting Page 18 Irrigation Pump User Manual Image Al none Off none Off Off Off Off Off BI Message Off Button STOP stuck Off Button stuck Off Generator commun ication Off none Off none Off none Reason The Stop button was pressed for more than 25 seconds or the Stop button is stuck The gt low standby flow gt gt high ablation flow gt gt gt flush flow or Stop button was pressed for more than 25 seconds or one of these buttons is stuck Two pumps are connected to the SMARTABLATE RF Generator
24. ny of the following locations e Onaclean flat stable surface e Ona CARTO 3 System cart e Onan intravenous IV pole see the instructions for use provided with the pole clamp 3 5 Mains Connection The SmarTABLATE Irrigation Pump automatically adjusts for the necessary mains 20 voltage and frequency To avoid the risk of electric shock connect the pump to a 3 prong mains outlet that meets the specifications in Section 7 1 Specifications Use only the mains cable supplied by the manufacturer or distributor for the country where the pump is being used 3 6 Fuses Ny Externally accessible fuses for the SMarTABLATE Irrigation Pump are located under the fuse cover see Item 25 in Section 3 2 Controls on the Back of the Pump Use only fuses approved by the manufacturer 3 7 Circular Plug Connections WAN The circular plugs on the SMARTABLATE System cables and the Q SMARTABLATE System foot pedal cable are color coded to ensure simple and accurate connection to the receptacles of the same color Ce on the back of the SMARTABLATE Irrigation Pump see Items 21 and 22 in Section 3 2 Controls on the Back of the Pump The indicator for the foot pedal receptacle and the indicator for the COMM 1 receptacle are orange to indicate that the receptacles are functional and are ready for connection To connect a circular plug to the pump align the arrow on the plug with the mark on the receptacle and push in without unnecessary
25. ode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 3 A m Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SMARTABLATE Irrigation Pump requires continued operation during power mains interruptions it is recommended that the SMARTABLATE Irrigation Pump be powered from an uninterruptible power supply Note that a 5 second removal of power as tested results in the device shutting down and requires user intervention to restart There was no interruption of operation for other tests Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level The SMARTABLATE Irrigation Pump was tested at 100 and 230 VAC 7 Technical Data Page 27 Irrigation Pump User Manual Electromagnetic Immunity The SMARTABLATE Irrigati
26. on Flow knob 12 High Ablation Flow button 13 Low Standby Flow knob 14 Low Standby Flow button 3 Pump Setup Page 5 Irrigation Pump User Manual Item Description 15 Pump door 16 Air bubble indicator F Air bubble sensor The transparent pump door allows viewing of the tubing and the pump head rotation 3 2 Controls on the Back of the Pump DEVICE LABEL FOOT ee 23 22 21 Item Description 18 Device label 19 Mains rating label 20 Sensor receptacles and indicators O not functional 21 Communication receptacles for RF generator and indicators O 22 Receptacle for foot pedal and indicator O 23 Mains socket 24 Potential equalization port 25 Fuse cover 3 Pump Setup Page 6 Irrigation Pump User Manual SMART 3 3 Diagram of the Pump with the SmartAsiate RF Generator and Accessories Patient Area Item 1 SMARTABLATE Irrigation Pump Mains cable Grounding cable Foot pedal Catheter SMARTABLATE RF Generator SMARTABLATE Irrigation Pump connection cable Catheter connection cable Oo OI NI ni mm BR Wl nu SMARTABLATE Irrigation Tubing Set Fluid bag See Chapter 4 Accessories M 3 Pump Setup Page 7 Irrigation Pump User Manual 3 4 Pump Location The SmarTABLATE Irrigation Pump can be located in a
27. on Pump is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Irrigation Pump should ensure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Conducted RF 3 Vrms 3V Portable and mobile RF communications IEC 61000 4 6 150 kHz to equipment should be used no closer to any part 80 MHz of the SMARTABLATE Irrigation Pump including Badiated BE 3V m 3V m cables than the recommended separation IEC 61000 4 3 80 MHz to distance calculated from the equation applicable 25 GHz to the frequency of the transmitter Recommended separation distance d 1 17VP 150 kHz to 80 MHz d 1 17VP 80 MHz to 800 MHz d 2 33 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol co Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strength
28. or additional instructions see Section 5 8 Communication with the SMARTABLATE RF Generator Adjusting the Volume Brightness and Language Options Screen OPTIONS Sound volume oe Sound volume Button brightness zte pa English iangoage SS service Battery Serial number Version Manufacturing date Turn off the pump and close the pump door Press and hold the Low Standby Flow button while you briefly press the Stand by button Release the Low Standby Flow button when the Options screen appears gt gt HIGH cs Turn the High Ablation Flow knob until gt appears to the left of the setting that you want to change 3 Pump Setup Page 9 Irrigation Pump User Manual SMART t gt iow O Then turn the Low Standby Flow knob to change the sound volume button brightness or language setting Press the Stand by button to remove the information from the screen The pump will turn off Note The Service selection on the Options screen is for use by a service engineer certified by the manufacturer 3 12 Cleaning and Disinfecting the Pump A wanns e The SmarTABLATE Irrigation Pump must be turned off and the mains cable must be disconnected from the pump before cleaning and disinfecting the pump e The SmarTABLATE Irrigation Pump the mains cable and the connection cable to the SMARTABLATE RF Generator must not be sterilized Use a dry microfiber cloth to clean t
29. or message and images appear on the pump s screen the Alarm indicator light turns on and the air bubble indicator light changes from green to red see Section 3 1 Controls on the Front of the Pump Immediately turn the 4 way stopcock on the SmarTABLATE Irrigation Tubing Set so that the fluid is not routed to the catheter Then press the Stop button to stop the alarm sound Flush the bubble s from the tubing per Section 5 3 Flushing to Eliminate Air in the Tubing and Catheter After flushing turn the 4 way stopcock to allow fluid to be routed to the catheter again Note After an air bubble has been detected the tubing must be flushed It is not possible to start fluid delivery using the Low Standby Flow or High Ablation Flow buttons if flushing has not been performed Communication with the SmartAs_Late RF Generator E m EE nen the pump is properly connected to the SMARTABLATE RF Generator this image appears at the bottom of the pumps screen You can control the pump from the generator when this image is displayed on the pump s screen a Gd grayed out image appears at the bottom of the pump s screen when the pump is connected to the generator and you use the pump s user interface to adjust a pump setting After the generator recognizes the change the white image shown above reappears Foot Pedal If a SMARTABLATE System foot pedal is connected to the pump the foot pedal can be pressed to
30. oubleshooting Page 20 Irrigation Pump User Manual Image Al BI Blinks Off red Blinks Off red Blinks Off red 6 3 System Errors Message Flow rate too low Button Foot pedal Reason The flow rate is lower than the set rate Either there is an interruption in the pump head rotation or there is a hardware failure A button was pressed while the pump was powering on The foot pedal was pressed too gently or not in the center or the foot pedal was pressed while the pump was powering on What To Do Check for an interruption in the pump head rotation such as a blocked fluid path in the tubing pinched tubing or damage to the tubing in the pump head area If an interruption is found clear the interruption If the tubing is damaged replace the tubing Then turn the pump off and on If the error persists contact Customer Support Turn the pump off and on If the error persists contact Customer Support Turn the pump off and on then press the foot pedal again If the error occurs again disconnect the foot pedal and connect a different foot pedal or try operating the pump without the foot pedal If the error persists contact Customer Support Each error situation generates an alarm see Section 7 9 Alarm Specifications Al Alarm Indicator see Item 7 in Section 3 1 Controls on the Front of the Pump BI Bubble Indicator see Item 16 in Section 3 1 Controls on the Front of t
31. pedal functions correctly when tested with the SMaRTABLATE Irrigation Pump e The flow rate is accurate Follow the instructions for use provided with the SMARTABLATE Irrigation Pump Test Kit If desired a service contract can be arranged Contact Customer Support 7 Technical Data Page 24 Irrigation Pump User Manual 7 6 Repairs There are no parts in the SMARTABLATE Irrigation Pump that may be serviced by the user Exception The fuses may be replaced per Section 3 6 Fuses Repairs or any changes to the pump and the accessories must be performed only by the manufacturer a service engineer authorized by the manufacturer or service centers certified by the manufacturer 77 Conformance to Standards The SMARTABLATE Irrigation Pump meets the requirements of the following standards Standard CAN CSA C22 2 No 601 1 B 90 CMDR DIN EN 980 DIN EN 1041 DIN EN ISO 14971 EU Dir 2002 96 EC EU Dir 2006 66 EC IEC 60812 IEC EN 60601 1 IEC EN 60601 1 1 IEC EN 60601 1 2 IEC EN 60601 1 4 IEC EN 60601 1 6 IEC EN 60601 1 8 IEC EN 60601 1 9 Title Medical electrical equipment Part 1 General requirements for safety Canadian Medical Devices Regulations Symbols for use in the labeling of medical devices Information supplied by the manufacturer of medical devices Medical devices Application of risk management to medical devices EU Directive 2002 96 EC of 27 January 2003 on waste ele
32. perating instructions Upper and lower temperature limits storage and shipping conditions Upper and lower humidity limitation storage and shipping conditions Upper and lower atmospheric pressure limitation storage and shipping conditions Keep dry All patient connections of the device are defibrillation proof type CF applied parts Lot number Catalog number Alarm Rotational adjustment Clockwise rotation increases value Flow direction Potential equalization port Foot pedal receptacle Communication connector to generator for example Sensor receptacle Fuses Alternating current 8 Symbols Page 32 Irrigation Pump User Manual Symbol Made in Germany C E0366 B el cal pat IP54 Description Manufacturer Manufacturing date Serial number Japanese version of the SmarTABLATE Irrigation Pump United States version of the SMARTABLATE Irrigation Pump Worldwide version of the SMARTABLATE Irrigation Pump except the United States Japan and China Medical General medical equipment as to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 NO 601 1 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 NO 60601 1 2008 40GF Caution Follow operating instructions Certificate of origin in Germany CE marking with the number of the notified body Separate collection for electrical and electronic equipment The device does not contain pht
33. quipment Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 VP d 1 17 VP d 2 33 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people EMC Information and Technical Description MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this user manual Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT A Warning The use of ACCESSORIES transducers and cables other than those specified with the exception of transducers and cables approved by the manufacturer of the SMARTABLATE Irrigation Pump as replacement parts for internal components may result in increased
34. reen the Alarm indicator and the air bubble indicator lights turn on red see Items 7 and 16 in Section 3 1 Controls on the Front of the Pump and an audible tone is emitted briefly If the logo does not disappear after 3 seconds or if the indicators do not light or if the tone cannot be heard there could be a problem see Section 6 4 Other Troubleshooting Note If the generator is on when the pump is connected to the generator the pump automatically turns on If the generator is off when the pump is connected to the generator the pump automatically turns on when the generator is turned on To turn the pump off press the Stand by button for at least 3 seconds Note If the pump is connected to the generator and the generator is on pressing the d pump s Stand by button puts the pump into sleep mode and the image at the right appears in the middle of the pump s screen When the generator is turned off the pump automatically turns off Note If the voltage of the internal battery is low the image at the right appears at the Zo bottom of the pump s screen You can continue to use the pump when this image is displayed but service will be required soon Contact Customer Support 5 2 Installing the SmartAs ate Irrigation Tubing Set in the Pump Fee e The tubing set is sterile and is intended for one time patient use e The tubing set can be damaged if inserted incorrectly e Always use a new sterile tubing set obtained f
35. reminder that high ablation flow is selected and that it is possible to overload the patient with fluid Verify that the pump head is rotating The pump head is located behind the transparent pump door See Items 2 and 15 in Section 3 1 Controls on the Front of the Pump 5 5 Setting the Low Standby and High Ablation Flow Rates same Refer to the instructions for use for the catheter to determine appropriate flow rates for the catheter The flow rates can be changed at any time including when low standby flow or high ablation flow is active gt Low O ez Turn the Low Standby Flow knob to set the low standby flow rate milliliters per minute gt Y HIGH O aD Turn the High Ablation Flow knob to set the high ablation flow rate milliliters per minute Note When the pump is connected to a SMARTABLATE RF Generator the generator will impose restrictions on the flow rate that can be set 5 Pump Operation Page 16 Irrigation Pump User Manual 5 6 5 7 5 8 5 9 Stopping the Irrigation Flow STOP Press the Stop button to stop the irrigation flow or Press the Stand by button briefly less than 3 seconds to stop the irrigation flow N Remove the tubing after use Air Bubble Error m H an air bubble is detected in the SMaRTABLATE Irrigation Tubing Set in the area of the pump s bubble sensor during high ablation or low standby flow the pump sounds an alarm an err
36. rference in nearby electronic equipment RF emissions Class A CISPR 11 The SmarTABLATE Irrigation Pump is suitable l e for use in all establishments other than Harmonic emissions Class A l domestic and those directly connected to the IEC 61000 3 2 i public low voltage power supply network Voltage fluctuations flicker Complies that supplies buildings used for domestic emissions purposes IEC 61000 3 3 7 Technical Data Page 26 Irrigation Pump User Manual Electromagnetic Immunity The SMARTABLATE Irrigation Pump is intended for use in the electromagnetic environment specified below The customer or user of the SMARTABLATE Irrigation Pump should ensure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 3 A m Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV differential m
37. rigation Tubing Set either the catheter must be outside the patient or the 4 way stopcock on the tubing set must be turned so that the fluid is not routed to the catheter After the tubing has been installed perform the following steps 0 Press and hold the Flush button to remove all air bubbles from the tubing and the catheter The pump head continues to rotate during flushing The following images appear on the screen during flushing to indicate whether bubbles are detected in the bubble sensor area Bubbles Detected During Flushing 5 Pump Operation Page 15 Irrigation Pump User Manual No Bubbles Detected During Flushing Note Flush for at least 5 additional seconds after the No Bubbles Detected During Flushing image appears and after there are no visible bubbles in the tubing This ensures that all bubbles have been flushed from the catheter 5 4 Starting the Irrigation Flow eee Low standby flow of the irrigation solution must be started before the catheter is inserted into the patient If the catheter is introduced into the patient before irrigation is started the holes in the catheter s tip electrode could become occluded due to thrombus formation LOW Press the Low Standby Flow button to start the pump at the low standby flow rate IGH Press the High Ablation Flow button to start the pump at the high ablation flow rate During high ablation flow the High Ablation Flow button blinks as a
38. rom its original packaging with each new procedure 5 Pump Operation Page 14 Irrigation Pump User Manual 5 3 Install the SmarRTABLATE Irrigation Tubing Set as described below Also see the instructions for use provided with the tubing Open the pump door see Item 15 in Section 3 1 Controls on the Front of the Pump Put the tubing between the pressure plate and the pump head see Items 1 and 2 in Section 3 1 Make sure that the arrows on the tubing point in the same direction as the arrows on the pressure plate Make sure that the tubing is in the grooves in the plates on each side of the pump head see the arrows in the drawing at the left Gently stretch the tubing that extends from the right side of the pump head and insert it in the air bubble sensor see Item 17 in Section 3 1 Close the pump door The pressure plate compresses the tubing to prevent fluid from flowing freely through the tubing set Take care not to pinch fingers when shutting the pump door After installing the tubing flush the tubing as described in Section 5 3 Flushing to Eliminate Air in the Tubing and Catheter The pump will not start fluid delivery if the tubing has not been flushed Flushing to Eliminate Air in the Tubing and Catheter Penis e Irrigated catheters must be flushed before they are inserted in the patient e When flushing a catheter the catheter must not be inside the patient When flushing the SMARTABLATE Ir
39. s from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SMARTABLATE Irrigation Pump is used exceeds the applicable RF compliance level above the SMARTABLATE Irrigation Pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SMARTABLATE Irrigation Pump b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m SS 7 Technical Data Page 28 Irrigation Pump User Manual Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SmarTABLaTE Irrigation Pump The SMARTABLATE Irrigation Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the SMARTABLATE Irrigation Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SMARTABLATE Irrigation Pump as recommended below according to the maximum output power of the communications e
40. s installing the pump in a safe location and protecting the pump against moisture contamination and contact with flammable or explosive substances Make sure that all cables to devices and accessories are arranged in a way that prevents tripping 3 Pump Setup Page 10 Irrigation Pump User Manual To transport the pump over long distances or to send the pump for service use the original packaging If the original packaging is not available contact the manufacturer or distributor for a replacement 3 14 Disposal Inadequately treated electronic waste poses environmental and health risks Follow local regulations for disposal of the SMARTABLATE Irrigation Pump and its electrical or electronic accessories To ensure proper disposal there is the option of contacting your Biosense Webster representative regarding return of the pump and its accessories 3 Pump Setup Page 11 Irrigation Pump User Manual 4 Accessories Pi ener Use only the original accessories provided by or recommended by STOCKERT GmbH or Biosense Webster for the SmarRTABLATE Irrigation Pump If you use accessories not authorized by the manufacturer the safety of the device and system is not guaranteed 4 1 Foot Pedal Foot Pedal length of connection cable 3 m Worldwide except China M490005 China M4900405 eee Foot Pedal Extension Cable length 7 m M490026 Redel 6 gt Redel 6 black 4 2 SmarTABLATE Cables Connection Cabl
41. sessessessesseseeseesee 17 I9 FOOT CM agsraaeaasa resect E OAA E A TE E A nee are ae nee 17 6 TROUBLESHOOTING 18 oT WAIN E a a E OE TE E E E O 18 O TO a A O E E E A A AE A 20 O VE ETO a E eerie ae eer eater ere ere mere ener eee ene 21 Irrigation Pump User Manual oh dee g al oubleshootihig erent mente ernennen teem reiasa ENEE Dss reen ak teraren teeter Pirni Teisti 6 5 Determining the Pump s Serial Number and Software Version csesesscsesessesesssesseseseseseess 7 TECHNICAL DATA 7AM SPE O ae ee re NN ee eer ee ee ee 7 2 Storage and Shipping Conditions vcsssscccareseccrsssvseceavenseconsantarieeacacotsssncendosasdiensceneavonssesucsaubeaseseoenssestvis A3 Operating Conditions eese renere A E NEE AEE EENES E EEN ETEEN ES EREE EEEREN OSEO rE E E Ea EE E N N E T A E A E Lo MainteNanN E gc sos cisco occcatpocecesceoecensoneccecicas sosecnsceroeceasonescessssoceeataosienecoasseesdesssoscvatgnsatsausspesusisaanosceatanonss LO TROP ANG oier EE E EA A EESE E E EEEE E E EEE TA Conformance to Standards nsec cac sacs tas ectesetsestteant cxecacntratiatsiseitner nesters aiiai i a easair 7 8 EMC Information and Technical Description sssscssisissccsicctsssicteddscsscstvsdscstivatasarseibsccsbscdvabaresbateccverts A9 PVA SCI CANO ING smena raia T AEEA eee ncnsaneteesets 8 SYMBOLS 9 WARRANTY FM VSI AS ain O WM a EE 93 Prod ct LiaDility ee ee eee ee ones er Irrigation Pump User Manual Preface The SMARTABLATE Irrigation Pump is a
42. start the pump in high ablation flow mode This is the same as pressing the High Ablation Flow button When the foot pedal is released the flow continues at the low standby flow rate a_i the foot pedal is properly connected to the pump this image appears at the bottom of the pump s screen 5 Pump Operation Page 17 Irrigation Pump User Manual 6 Troubleshooting 6 1 Warnings Al Alarm Indicator see Item 7 in Section 3 1 Controls on the Front of the Pump BI Bubble Indicator see Item 16 in Section 3 1 Controls on the Front of the Pump Image Al Off On red Off none Off none Off none Off BI Off Off Blinks red Off Off Off Message none Door open none Button gt stuck Button gt gt stuck Button gt gt gt stuck Reason The door is open during no flow The door is open during high ablation low standby or flush flow A bubble was detected during no flow either because there is air in the tubing or because the tubing is not in the bubble sensor The gt low standby flow button was pressed for more than 25 seconds or the gt button is stuck The gt gt high ablation flow button was pressed for more than 25 seconds or the gt gt button is stuck The gt gt gt flush flow button was pressed for more than 25 seconds or the gt gt gt button is stuck What To Do N A information only N A infor
43. tion 3 1 Controls on the Front of the Pump BI Bubble Indicator see Item 16 in Section 3 1 Controls on the Front of the Pump Reset No Event Tone Al BI Action Comments 1 The gt low Pulse pattern none Off Off none Information standby tone flow gt gt high Tone be Hain ablation flow 2 KHz 20 gt gt gt flush flow or Jone on 25 ms Stop button was pressed 2 The foot pedal Pulse pattern none Off Off none Information was pressed tone Tone frequency 2 kHz 20 Tone on 25 ms 3 The foot pedal Pulse pattern none Off Off none Information was released tone Tone frequency 2 kHz 20 Tone on 25 ms 4 High ablation Pulse pattern none Off Off none Information flow was started tone from generator Tone i ei does not apply 2 kHz 20 to SMARTABLATE Tone on 25 ms RF Generator 5 High ablation Pulse pattern none Off Off none Information flow was stopped tone Tone frequency from generator 2 kHz 20 does not apply to SMARTABLATE RF Generator Tone on 25 ms 7 Technical Data Page 30 Irrigation Pump User Manual No Event Door open message Big bubble message Many small bubbles message Motor direction message Flow not zero message Other errors examples Flow rate too low Foot pedal Motor power supply messages Tone Pulse pattern none Tone frequency 2 kHz 20 Tone on 25 ms Pulse pattern ti ti
44. usting the Volume Brightness and Language ssesssessesseessessessesseessessesseessceseessesseoseessesseosees 9 3 12 Cleaning and Disinfecting the PUMP se ssessseessesssesseesseesseesseesseesseoseeoseesseesecoseeoseesseeoseesseeseoseesseesse 10 3 13 Protecting against Damage sseseseeseosssessoressosesesronessosesersesroneseoresesronesroresesrenesrosesessessonrsroresesronesees 10 eM DIPO a E A A EN E AN 11 4 ACCESSORIES 12 ai FOOF OG Eon N A EN EE NE E AET A OEE E 12 A2 SMARTABLATE CaDICS shrccrrarcatcrnteniqentntansensna wena EEN ANEROS EATEN EEA KeS EROE REENEN RO 12 do ARINC C5 SS oaa E E E EE 13 5 PUMP OPERATION 14 51 Tumingthe PumMPONaNd O Tasesa inn ae ESEN NENAS NEE EEA SEa 14 5 2 Installing the SmarTABLAaTE Irrigation Tubing Set in the PUMP ssesssesssesseesssesseessesssesseesseesse 14 5 3 Flushing to Eliminate Air in the Tubing and Catheter uc esssscsssssessssssssssscssssssssssssssesesees 15 5 4 Starting the Irrigation FIOW sisssuissscasoscssepsiaeusnsovicosossscassavavenstonenceseaebeneniussenaseoetnpaseoveevastantansnnasoeeteuaaaenins 16 5 5 Setting the Low Standby and High Ablation Flow RateS ssesssesseesseessesssesssesssesssesseesse 16 5 6 Stopping the Irrigation FLOW ssssesecscscsessscscssssssssssesesescscssssssssesesesesesesesesesssseeesesesesescssseesesesees 17 TY AN BUDDIG EOL oaee E RE R aN 17 5 8 Communication with the SmMarRTABLATE RF Generator ssessessessessesseseeseeseeseesses
45. with the SMARTABLATE RF Generator and all accessories and read their instructions for use before using the generator or accessories For more information on training options please contact Biosense Webster We will gladly answer any questions that you may have Yours truly STOCKERT GmbH Irrigation Pump User Manual 1 Indications The SMARTABLATE Irrigation Pump is a peristaltic pump designed to work in conjunction with the SMARTABLATE RF Generator to deliver irrigation solution at specified flow rates to irrigated catheters such as the Biosense Webster CELsius THERMOCOOL Catheters and NaviSTar THERMOCOOL Catheters for cooling purposes The pump is used with the SMARTABLATE Irrigation Tubing Set that conducts the irrigation solution from an external source to the compatible irrigated catheters 1 Indications Page 1 Irrigation Pump User Manual 2 Warnings 1 10 11 Before setting up the SMARTABLATE Irrigation Pump for the first time carefully read this user manual Pay special attention to the instructions in Chapter 3 Pump Setup Also read the user manuals for the SMARTABLATE RF Generator and the accessories and familiarize yourself with their use Always verify that the pump s visual and acoustic alarms are working before using the pump see Section 5 1 Turning the Pump On and Off When the pump has been turned off power continues to be supplied to the pump through the mains cab
46. y Product liability is assumed by STOCKERT GmbH under the following conditions e The pump has been operated only with original STOCKERT GmbH accessories see Chapter 4 Accessories e Repairs to the pump and to the accessories have been performed only by the manufacturer a service engineer authorized by the manufacturer or a service center authorized by the manufacturer 9 Warranty Page 34 Irrigation Pump User Manual Manufactured By peal STOCKERT GmbH Botzinger Stra e 72 79111 Freiburg Germany Fax 49 761 20716 20 Email info stockert de http www stockert de Customer Support In USA Biosense Webster Inc Tel 1 866 4SERVCE 1 866 473 7823 toll free in USA Email complaint bwius jnj com Customer Support Outside USA Biosense Webster Tel 32 2 7463 463 Email techsupport its jnj com Distributed By Outside USA In USA Biosense Webster Biosense Webster Inc A Division of Johnson amp Johnson Medical NV SA 3333 Diamond Canyon Road Leonardo da Vincilaan 15 Diamond Bar California 91765 USA 1831 Diegem Belgium Tel 1 866 473 7823 Tel 32 2 7463 401 Fax 1 909 468 2786 Fax 32 2 7463 403 http www biosensewebster com Carto Cetsius NAvISTAR SMARTABLATE and THERMOCOOL are trademarks of Biosense Webster Inc The third party trademarks listed herein are trademarks of their respective owners Caution Federal USA law restricts this device to sale by or on the order of a physici
Download Pdf Manuals
Related Search