COOLFLOW™ IRRIGATION PUMP USER MANUAL
Contents
1. 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 NOTE Uris the a c mains voltage prior to application of the test level The CooLFLow Irrigation Pump was tested at 100 and 230 VAC 1 16 V CooLFLow Irrigation Pump User Manual English 7 Table 4 Electromagnetic immunity Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the COOLFLOW Irrigation Pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 JP d 1 17 JP d 233 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 150 kHz to 80 MHz 80 MHz to 800 MHz Interference may occur in the vicinity of equipment marked with the following symbol Co CooLFLow Irrigation Pump ELECTROMAGNETIC IMMUNITY The2. EN60601 2 24 1998 applicable parts 100 240V 50 60Hz 45VA grounded 3 wire hospital grade outlet Use 2A 250V fuses operating 10 C to 40 C 20 to 90 non condensing 1 to 5 ml min 1 ml min increments 5 to 30 ml min 1 ml min increments 60 ml min 35 PSI 2 4 atm 30 ml min lt 100 PSI 6 8 atm 5 10 6 30ml min 10 20 1 5 ml min 2 micro liters 30 cm 21 cm without pole clamp attached 24 cm 7kg 3m AC power requirements Environmental conditions Temperature Relative Humidity Flow rate range low range Flow rate range high range Flush flow rate Maximum operating back pressure Maximum pressure generated Flow rate accuracy Minimum detectable bubble size Dimensions Height Width Depth Weight Power cord CooLFLow Irrigation Pump User Manual English 5 EMC Information The COOLFLOW Irrigation Pump complies to the requirements for electromagnetic compatibility EMC for medical devices as defined in IEC 60601 1 2 2001 To help the user ensure optimum operation the following tables indicate the acceptable electromagnetic environment for operating the COOLFLOW Irrigation Pump Use of accessories other than those specified may result in increased emissions or decreased immunity of the equipment Use only Biosense Webster accessories approved for use with the COOLFLOW Irrigation Pump Table 2 Electromagnetic emissions ELECTROMAGNETIC EMISSIONS The CooLF
3. 5 Close up of the CooLFLOW pump mi7min control panel 08 JE ve LR go Bo CX Use of the controls is detailed below Stop button Press to Stop rotation of the pump head The pump will CO beep once to indicate that flow has stopped Press the Low Flow or High Flow button to restart the flow Flush button Press to flush the tubing set A flow of 60 ml min is D initiated and continues until the button is released Detection of air in the tubing is disabled during this process Low Flow button Press to initiate flow at the preset low flow rate The pump beeps once when the low flow rate begins The default low flow rate is 2 ml min M CooLFLow Irrigation Pump 1 10 User Manual English High Flow button Press to initiate flow at the preset high flow rate The pump beeps twice when the high flow rate begins The default high flow rate is 30 ml min Increase Decrease buttons There are two sets of Increase Decrease buttons one set under the Low Flow button the other under the High Flow button Press the or button to increase or decrease the respective flow rate by 1 ml min When adjusting the high or low flow rate the LED display temporarily indicates the new setting for the associated flow rate regardless of the current flow rate of the pump The new setting remains in effect until it is changed or the pump is turned off Alarm Silence button When an
4. CooLFLow Irrigation Pump is intended for use in the electromagnetic environment specified below The customer or the user of the COOLFLOw Irrigation Pump should assure that it is used in such an environment Compliance level 3V 3 V m IEC 60601 test level 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Immunity test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 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 1 18 User Manual English Field strengths 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 CooLFLow Irrigation Pump is used exceeds the applicable RF compliance level above the COoLFLow 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 CooLFLow Irrigation Pump Over the frequency range 150 kHz to 8
5. error is detected by the pump the error code appears on the LED display and an audible alarm is heard Press this button to silence the audible alarm for 2 minutes The error code remains displayed until the Clear Error button is pressed see below Clear Error button Once an error has been corrected press and hold the CLR button for 1 second to clear the error from the display The pump returns to normal operating mode LED Display The two digit seven segment LED display indicates the flow rate of the pump in ml min The actual flow rate is dependent on the tubing set integrity and fluid back pressure When the pump is stopped 0 ml min is indicated When an error is detected the error code is displayed until that error has been cleared Once the error is corrected see Section 6 Alarms and Error Codes use the Clear Error button see above to return to normal operation When adjusting the flow rate the new setting for the associated flow rate is briefly displayed regardless of the current flow rate of the pump For example 11 the pump is currently running at a low flow rate of 2 ml min and the high flow rate setting is changed the new high flow rate setting is momentarily displayed 0 6 CLR CooLFLow Irrigation Pump User Manual English 1 5 USING THE FOOT PEDAL OPTIONAL The foot pedal may be used to momentarily initiate a high flow rate To connect the foot pedal to the pump 1 Place the Redel conn
6. located on the back panel near the power cord inlet Once turned on the pump performs a self test and you will hear a short beeping tone Once the self test has passed you will hear the tone again and the display will indicate a flow rate of 0 ml min Figure 3 Rear view of the CooLFLow Pump 6 AC power inlet 7 Power switch 8 Foot pedal connector 9 Alternate foot pedal connector 10 Ground Stud Loading the Tubing Set in the Pump NoTE Use only the Biosense Webster COOLFLOW Tubing Set To load the COOLFLOW Tubing Set in the pump refer to Figure 4 1 Connect the COOLFLOW Tubing Set to the IV solution container using standard safe hospital practices e A new tubing set must be used for every procedure Do not reuse the tubing set 2 Connect a stopcock to the patient end of the tubing set CooLFLow Irrigation Pump 1 8 User Manual English 3 Open the stopcock and fill the tubing set with irrigation fluid Remove any trapped air and then close the stopcock 11 17 16 Figure 4 Loading the tubing set in the pump See text for details 4 Hang the IV solution container near the pump and fill the drip chamber about 2 3 full 5 Open the door of the pump and release the spring arm 11 from the pressure plate 12 6 Install the Large Tubing Stop 13 of the tubing set into the Lower Tubing Retainer
7. the pump to steam autoclave or ethylene oxide EO sterilization e Do not expose the pump to excessive moisture especially when AC power is connected Cleaning Preventive Maintenance It is recommended that periodic inspections be performed annually Verification of the flow rate accuracy should be performed every six months Detailed instructions for performing the inspection and testing can be found in the COOLFLOW Irrigation Pump Service Manual available from Biosense Webster Inspections should be performed by qualified personnel only Calibration Adjustments There are no user serviceable components in the pump The pump is calibrated by the manufacturer Improper operation or damage to the pump can occur if altered by unauthorized personnel Disconnect AC power prior to long term storage Check that the pump door is closed when the pump is not in use Store the pump within the environmental conditions recommended for operation CooLFLow Irrigation Pump Storage User Manual English SPECIFICATIONS The COOLFLOW Irrigation Pump is classified as Class I type CF ordinary equipment for continuous use as defined by International Standard EN60601 1 The Foot Switch is classified as IPX8 equipment for continuous immersion as defined by International Standard IEC529 The COOLFLOW Irrigation Pump complies with the following standards EN60601 1 1988 EN60601 1 2 2001 1 CAN CSA 22 2 0
8. 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 COOLFLOw Irrigation Pump requires continued operation during power mains interruptions it is recommended that the COOLFLOw 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 Compliance level 6 kV contact 8 kV air 2 kV for power supply lines kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in U7 for 0 5 cycle 40 Ur 60 dip in U for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in U7 for 5 sec 3 A m IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in U7 for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in U7 for 5 sec 3 A m Immunity test Electrostatic discharge ESD IEC 61000 4 2
9. 0 MHz field strengths should be less than 3 V m Table 5 Recommended separation distances between portable and mobile RF communications equipment and the CooLFLow Irrigation Pump RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE CooLFLow IRRIGATION PUMP The CooLFLow Irrigation Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the COOLFLOW Irrigation Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CooLFLow Irrigation Pump as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W 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
10. 14 Note the pump rotates in a clockwise direction 7 Lay the tubing over the rollers on the left side of the pump head 15 8 Gently stretch the tubing and place the Small Tubing Stop 16 of the tubing set into the Upper Tubing Retainer 17 Do not twist the tubing 9 Place the smaller diameter tubing sections 18 fully into each Air In Line Detector 19 e To ensure proper operation of the Air In Line Detectors the outer surface of the tubing must be dry 10 Close the pressure plate and latch the spring arm e Closing the pressure plate prevents free flow of fluids though the tubing set 11 Close the transparent door of the pump CooLFLow Irrigation Pump User Manual English 1 9 Preparing for Irrigation To prepare for irrigation 1 Open the stopcock on the end of the tubing set 2 Press and hold the Flush button 2 to verify tubing integrity e If you see any air in the tubing hold down on the Flush button until the air is expelled through the open end of the tubing 3 Securely connect the tubing to the ThermoCool Catheter The COOLFLOW Irrigation Pump is now ready for use WORKING WITH THE CONTROL PANEL The control panel located on the front of the pump is used to set and display the flow rate and to control pump operation A close up of the control panel is shown in Figure 5 ra Coot tow Figure
11. A a company COOLFLOW IRRIGATION PUMP USER MANUAL Manual P N M 5276 323A M 5276 323A CE 0086 2001 Biosense Webster Inc All rights reserved Biosense Webster Inc 3333 Diamond Canyon Road Diamond Bar CA 91765 USA Tel 1 909 839 8500 Tel 1 800 729 9010 Fax 1 909 468 2905 www biosensewebster com Biosense Webster Johnson amp Johnson Medical NV SA Dreve Richelle 161 Building H B 1410 Waterloo Belgium Tel 32 2 352 1411 Fax 32 2 352 1592 COOLFLOW is a trademark of Biosense Webster Inc Caution Federal U S A law restricts this device to sale by or on the order of a physician Manual P N User Manual English 1 CooL_FLow Irrigation Pump User Manual English TABLE OF CONTENTS 1 Device Description 1 3 Unpacking the 1 3 Electrical CONNECTIONS eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeees 1 4 2 Safety Information 1 4 Intended Use 1 4 AM ANUS 1 4 1 5 3 Setting Up the COOLFLOW Pump 1 6 IV Pole MOUNE 1 6 Turning the Pump Reepeeenrrerrrrrrreeeer Terre rreeter irre mtrer errr retrrrrrr er Tyr 1 7 Loading the Tubing Set in the 1 7 Preparing for wes Realdagonisaceusnaniendntd 1 9 4 Working with the Control Panel 1 9 5 Using the Foot Pedal optional 1 11 6 Alarms and Error
12. Codes 1 11 7 Preventive Maintenance Service 1 13 Cleaning osc tak san dees hai ai a a A E TEA E a E 1 13 1 13 Calibration Adjustments tee tineesiaen 1 13 Storage cas ee eee ne ee ene ee renee ee eee eee ES 1 13 8 Specifications 1 14 EMC Information 1 15 9 Accessories 1 19 10 Limited Warranty amp Limitation of Liability 1 20 CooLFLow Irrigation Pump 1 2 User Manual English LIST OF FIGURES amp TABLES Figure 1 The COOLFLOW Irrigation PUMP 1 3 Figure 2 Front view of the COOLFLOW PUMP sssanssssssssunnnnnnnnnnnnennnnnnnnnne 1 6 Figure 3 Rear view of the COOLFLOW PUMP 1 7 Figure 4 Loading the tubing set in the PUMP csseeeeeeeeeeeeeeeeeeeeeee 1 8 Figure 5 Close up of the COOLFLOW pump control panel 1 9 Figure 6 The optional Foot Pedal used with the COOLFLOW PUM 1 11 Table 1 Alarms and Error Codes and the appropriate action 1 12 Table 2 Electromagnetic emissions cccceeseeeeeeeeeeeeeeeeeeeeeereeeeees 1 15 Table 3 Electromagnetic immunity 1 16 Table 4 Electromagnetic immunity 27 1 17 Table 5 Recommended separation distances between portable and mobile RF communications equipment and the 1 18 CooLFLow Irrigation Pump User Manual English 3 1 DEVICE DESCRIPTION The COOLFLOW Irrigation Pump is a peristaltic pump designed for the delivery of irrigatio
13. Low Irrigation Pump is intended for use in the electromagnetic environment specified below The customer or the user of the COOLFLOw Irrigation Pump should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The CooLFLow Irrigation Pump uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The CooLFLow Irrigation Pump is suitable for a use in all establishments other than domestic Harmonic emissions Class A and those directly connected to the public low IEC 61000 3 2 voltage power supply network that supplies Voltage fluctuations flicker Complies buildings used for domestic purposes emissions IEC 61000 3 3 CooLFLow Irrigation Pump User Manual English Table 3 Electromagnetic immunity ELECTROMAGNETIC IMMUNITY The CooLFLow Irrigation Pump is intended for use in the electromagnetic environment specified below The customer or the user of the COOLFLOw Irrigation Pump should assure that it is used in such an environment 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
14. Y ON THIS PRODUCT FOR REPAIR OF THE PUMP IN THE EVENT THAT A REPAIR IS NECESSARY AS A RESULT OF A DEFECT IN MATERIALS OR WORKMANSHIP REPAIRS MUST ONLY BE PERFORMED BY THE MANUFACTURER OR AN AUTHORIZED REPRESENTATIVE OF THE MANUFACTURER THIS LIMITED ONE YEAR WARRANTY PERIOD BEGINS ON THE DATE OF DELIVERY THERE ARE NO WARRANTIES WHICH EXTEND BEYOND THE DESCRIPTION ON THE FACE HEREOF EXCEPT FOR THE LIMITED ONE YEAR WARRANTY DESCRIBED ABOVE THERE IS NO EXPRESS OR IMPLIED WARRANTY INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ON THE PRODUCT S DESCRIBED HEREIN UNDER NO CIRCUMSTANCES SHALL BIOSENSE WEBSTER INC OR ITS AFFILIATED COMPANIES BE LIABLE FOR ANY SPECIAL DIRECT INCIDENTAL CONSEQUENTIAL OR OTHER DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW WITHOUT LIMITING THE FOREGOING BIOSENSE WEBSTER INC OR ITS AFFILIATED COMPANIES SHALL NOT BE LIABLE FOR ANY SPECIAL DIRECT INCIDENTAL CONSEQUENTIAL OR OTHER DAMAGES ARISING OUT OF THE REUSE OF ANY PRODUCT S LABELED FOR SINGLE USE OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW Descriptions and specifications appearing in Biosense Webster printed matter including this publication are informational only and meant solely to generally describe the product at the time of manufacture and are not made or given as a warranty of the prescribed product in any way CooLFLow Irrigation Pump
15. ector of the COOLFLOW Pedal Figure 6 in the socket at the back of the pump 8 in Figure 3 e The foot pedal is ready for use immediately upon connection 2 An additional foot pedal connector 9 D shaped 9 pin is also provided on the back panel For further details about this feature contact your Biosense Webster representative or refer to the COOLFLOW Irrigation Pump Service Manual available from Biosense Webster To initiate the high flow rate with the pedal set Check that the pump is stopped or running at a low flow rate 2 Press and hold on the foot pedal e You will hear two beeps indicating initiation of the high flow rate e High flow is maintained while the pedal is held down 3 To stop the high flow rate release the foot pedal e You will hear one beep indicating a return to the low flow rate Figure 6 ee The optional Foot a Pedal used with the CooLFLow Pump j 27 6 ALARMS AND ERROR CODES When an error occurs or an alarm is activated an audible warning is heard The associated error alarm code is shown in the LED display and the pump is stopped exception see Air Bubble Detected below The audible alarm can be temporarily silenced by pressing the Alarm Silence button The code remains displayed and the audible alarm returns after 2 minutes To clear an alarm or error press and hold the CLR button for 1 second The pump will remain stopped and return to the n
16. en used with incompatible fluids or delivery devices e The COOLFLOW Irrigation Pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary observe the COOLFLOW Irrigation Pump to verify normal operation in the configuration in which it will be used CooLFLow Irrigation Pump User Manual English 1 5 Precautions e To avoid the possibility of biological contamination and to ensure proper performance do not reuse or resterilize the COOLFLOW Tubing Set The tubing set is intended for single use only e Positive displacement irrigation pumps such as the COOLFLOW Pump should not be ported together with other infusion systems including gravity fed IV infusion systems e To avoid the risk of explosion do not use the pump in the presence of flammable anesthetics e To avoid the risk of electrical shock and fire do not expose the pump to excessive moisture e External high energy radio frequency interference RFI and electromagnetic radiation EMR can cause false alarms or compromised performance in electrical equipment such as the COOLFLOW Pump In addition electrical equipment such as the pump can occasionally induce artifacts on ECG monitor ing systems that are not operating under optimal conditions Although the pump has been designed to prevent such interference safe operation should be verified prior to patient use when used in conjunction with RF electro surgical equip
17. ment electromagnetic navigation systems and ECG monitoring equipment If interference occurs reposition the pump e The pump has no user serviceable components e The pump is calibrated by the manufacturer Alteration of pump settings will cause improper operation and result in cancellation of the warranty e Moving parts such as the transparent door pole clamp and rotating pump head while designed for safe operation should be operated with care CooLFLow Irrigation Pump 1 6 User Manual English 3 SETTING UP THE COOLFLOW PUMP Figures 2 and 3 provide front and rear view details of the COOLFLOW Pump respectively IV Pole Mount The pump can be mounted on a standard IV pole or a horizontal mounting rail using the removable pole clamp 1 in Figure 2 To install the pole mount 1 Securely clamp the pole clamp onto the IV pole or mounting rail near the patient 2 Slide the mounting post into the pole clamp Make sure that the pole is stable prior to use e tis recommended that a 5 legged hospital grade IV pole be used e To ensure stability the pump should not be mounted higher than 135 cm above the base of the pole Figure 2 Front view of the CooLFLow Pump 1 Pole clamp 2 Door latch 3 Pump Head 4 Control Panel 5 LED display CooLFLow Irrigation Pump User Manual English 5 7 Turning the Pump On The power switch 7 in Figure 3 is
18. n solutions when used in conjunction with the COOLFLOW Tubing Set and a ThermoCool Catheter The pump has a dual rate feature for one touch irrigation rate change between a low flow rate 1 5 ml min and a high flow rate 5 30 ml min A large LED display indicates the flow rate selected An optional foot pedal can be used to initiate high flow irrigation Figure 1 The CooLFLow Irrigation Pump A transparent door protects the rotating head while allowing visibility of the entire tubing set during pump operation Dual air in line detectors are employed for added safety in preventing air infusion Audible alarms warn of air in the tubing an open door or operational errors A removable side mounted pole clamp is included for mounting the pump to an IV pole or a horizontal mounting rail Unpacking the Pump Remove the pump and power cord from the shipping container Inspect the pump If the pump has been damaged during shipping please contact your nearest Biosense Webster Sales or Customer Service representative CooLFLow Irrigation Pump 1 4 User Manual English Electrical Connections The pump operates using line power of 100 to 240V 50 to 60Hz Connect only to a properly grounded 3 wire hospital grade power receptacle The pump is not battery powered and cannot be used as portable equipment 2 SAFETY INFORMATION Intended Use Indications The COOLFLOW Irrigation Pump and Tubing Set is a peristaltic i
19. ormal operating mode A list of alarm and error codes with the appropriate course of action is provided in Table 1 CooLFLow Irrigation Pump 1 12 User Manual English Table 1 Alarms and Error Codes and the appropriate action Codes are listed in alphabetical order Code Alarm Error Type Action bF Bubble Detector Self Test Failure gt Turn power off and on again Periodic self test of the air in line gt Ifthe failure occurs repeatedly sensors has failed contact your local Biosense Webster Sales or Customer Service representative Blinking High Flow Rate Time Reminder gt Press the Silence Alarm button to stop Flow Rate The pump has been operating at a the audible alarm for 2 minutes in LED high flow rate for more than 6 Or splay gt Switch to the low flow rate bu Air Bubble Detected Air was gt Examine the tubing for trapped air detected in the tubing by one of the gt Remove the patient line from the air in line sensors The pump will patient and use the Flush button to continue to rotate for 3 seconds purge air from the system before stopping to briefly ensure gt Check that the tubing is properly continued irrigation while any associated equipment is turned off or seated in the Air in Line detectors removed from the patient gt Check for wet or dirty tubing in the Air in Line detectors gt Check for damaged or blocked tubing Ch Self Test A hardware self tes
20. rrigation pump designed for the delivery of saline solution when used in conjunction with the Stockert 70 RF Generator and the ThermoCool Irrigation Catheter Warnings e The COOLFLOW Pump is designed for use with only the Biosense Webster COOLFLOW Tubing Set only Use of inappropriate tubing may cause improper operation of the pump and can result in improper irrigation e The COOLFLOW Pump is designed to stop the flow of irrigation solution when an alarm is activated All alarms must be attended to immediately to ensure continued irrigation e The COOLFLOW Pump is designed for use with the ThermoCool catheter and the Stockert 70 Generator which can detect hazard conditions caused by insufficient irrigation flow to the catheter tip Flow can be verified visually by noting the drip rate in the drip chamber Hospital personnel are responsible for verifying and monitoring the flow rate delivered to prevent under infusion of irrigation fluid e Hospital personnel are responsible for monitoring the total saline load delivered to the patient to prevent over infusion of irrigation fluid e Hospital personnel are responsible for verifying the proper performance of the pump and the compatibility of the solutions and irrigation devices used as part of the overall irrigation management The COOLFLOW Pump and Tubing Set are de signed for use with standard irrigation solutions such as normal saline Specified flow rate accuracy may not be maintained wh
21. t is in gt If Ch remains displayed for more than progress one minute the system failed one or more self tests on power up gt Ifthe test fails repeatedly contact your local Biosense Webster Sales or Customer Service representative do Door Open The door is open during gt Close the door and verify that the door pump operation latch is securely fastened Fo Foot Pedal Communication with the gt Check that the Foot Pedal plug is Foot Pedal has been lost during high securely connected to the pump flow operation Pr Internal Processor Error An gt Contact your local Biosense Webster internal error has been detected in Sales or Customer Service the micro controller or one of its representative supporting components rl Rotation Velocity Error The pump gt Check for improper installation of the head rotation speed was not as tubing set expected r2 Reverse Rotation Error Reverse gt Check for improper installation of the pump head rotation was briefly tubing set detected CooLFLow Irrigation Pump User Manual English 3 7 PREVENTIVE MAINTENANCE SERVICE The pump can be wiped clean with a damp cloth using standard hospital practices Prior to cleaning the pump be sure to disconnect it from the AC power supply In addition e The pump head and pressure plate should be wiped clean after each use e Do not immerse the pump in any liquid or expose
22. 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 CooLFLow Irrigation Pump User Manual English 9 Please note the following when installing and operating the COOLFLOw Irrigation Pump e There are special precautions regarding EMC when installing and servicing medical equipment Be sure the COOLFLOW Irrigation Pump is installed and put into service according to the EMC information provided e Portable and mobile RF communication equipment can adversely affect medical devices Be sure to keep RF communication devices away from the COOLFLOW Irrigation Pump at least as recommended in table 5 Warning The COOLFLOwW Irrigation Pump should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary observe the COOLFLOW Irrigation Pump to verify normal operation in the configuration in which it will be used 9 ACCESSORIES Foot Pedal optional Biosense Webster Catalog No 57005 U S Catalog No 39D03X Europe Administration Set Biosense Webster Catalog No CFT001 COOLFLOW Tubing Set U S amp Europe CooLFLow Irrigation Pump 1 20 User Manual English 10 LIMITED WARRANTY amp LIMITATION OF LIABILITY BIOSENSE WEBSTER INC PROVIDES A LIMITED ONE YEAR WARRANT
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