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USER GUIDE - Surgeons Choice

1. RAM test error CRC check error Watchdog error Local IC BUS errors EEPROM Controller IC BUS error nu Controller defective Software inconsistency Heat sink MP1 Heat sink MP2 Case temperature Int A D converter reference voltage and analog multiplexer Ground High power supply 0 V test High power supply watchdog test Power supply enable test Power down test High power supply error U test High power supply error test MPU1 self test error Power level 2 error Power level 3 error Power level 4 error Power level 5 error Power level 6 error RF enable error Current level 0 error Current level 1 error Watchdog reset Excess output power Faulty variable contents Mutual time monitoring of MPUs Power supply voltage exceeds tolerances Power supply current exceeds tolerances Oscillator frequency exceeds tolerances Pump voltage exceeds tolerances Pump current below tolerances Pump current exceeds tolerances Power down capacitor test Power failure occurred Command error 8 2 8 3 Error Code Notes 1 Check listen for proper blower operation Ensure that the recommended duty cycle 40 secs on 80 secs off is observed 2 Error code 023 MPU1 error has its own subset of error conditions See MPU1 Error section below 3 Check proper fu
2. where it enters and exits the pump head Spiking the Saline Bag 1 Hang a bag of sterile saline 0 9 NaCl solution on the Aquamantys Cart I V pole or another I V support which is in close proximity to the Aquamantys Pump Generator 2 Remove the protective cover over the spike of the drip chamber at the end of the device s saline delivery tubing Using aseptic technique spike the bag of sterile saline 0 9 NaCl solution 4 Squeeze the drip chamber once or twice to fill the drip chamber to a level of at least one third full This is shown below in Figure 4 6 Figure 4 6 Spiking the saline bag 4 6 Priming the Aquamantys Disposable Bipolar Device 1 Press the START PRIME button as shown in Figure 4 7 This initiates priming of the Aquamantys disposable bipolar device with saline The pump will operate for a preset time period to prime the Aquamantys device The pump head speed is accelerated during the priming cycle compared to normal use The Aquamantys device is primed when saline drips from both of the electrodes of the device After the priming cycle is complete the pump shuts off automatically The Priming Underway indicator will illuminate amber when priming is activated and shut off darken after the priming cycle is complete Figure 4 7 Initiating Priming of the Aquamantys Disposable Bipolar Device Precautions Always place the device into a holster or over a container to collect the
3. lx 2 4 This equipment intentionally supplies non ionizing RF energy for physiologic effect Volume control of RF power activation tone Do not operate in oxygen enriched environments High setting for saline flow rate Medium setting for saline flow rate Low setting for saline flow rate Caution Moving Parts Risk of Injury This equipment has passed water ingress testing Activates deactivates device priming sequence Section 3 Patient and Operating Room Safety Warnings Precautions Warnings It is important that the operating instructions supplied with this or any electrosurgical equipment be read understood and followed The Aquamantys Pump Generator is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment technology and techniques Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation It is recommended that physicians utilize pre clinical training review of pertinent literature and other appropriate educational tools before attempting newer surgical procedures such as endoscopic laparoscopic or thoracoscopic procedures General Use the Aquamantys System with caution in the presence of pacemakers as electrosurgical equipment may cause interference with pacemakers or o
4. High saline flow rate High 66 Medium saline flow rate Medium A A Low saline flow rate Low A The three possible saline flow rates are preset for each given power setting See Figure A 3 on page A 5 for more detailed information on the saline flow rates for each given power setting The saline flow rate setting cannot be adjusted while the Aquamantys disposable bipolar device is being activated The flow rate setting Indicator next to the selected flow rate will be illuminated amber to indicate the current flow rate setting Activating the Aquamantys System Do not activate the Aquamantys disposable bipolar device when the electrodes are not in contact with the tissue to be treated Activating off tissue may result in inadvertent tissue damage or user injury due to contact with hot saline Use the Aquamantys disposable bipolar device only until the desired tissue effect is achieved 1 Press the activation button on the hand piece of the Aquamantys disposable bipolar device to simultaneously activate RF power and saline flow from the device 2 Release the activation button on the hand piece of the Aquamantys disposable bipolar device to shut off both RF power and saline flow from the device Pressing the activation button on the Aquamantys disposable bipolar device will activate the Aquamantys Pump Generator The RF Power Activation Indicator will illuminate blue and a continuous RF activation tone will sound to indicate the pre
5. Pressing the button a third time will reset the timer and restart the priming cycle from the beginning Priming Underway Indicator This indicator will be illuminated during the priming cycle and turn off when the priming cycle is complete Flow Rate Setting Indicators These indicators correspond to a saline flow rate setting of Low Medium or High One of these three indicators will be illuminated when a saline flow rate setting is selected Flow Rate Setting Buttons These buttons control the saline flow rate Pressing one of these three buttons selects the flow rate setting of either Low Medium or High for each respective power setting The Medium flow rate setting is automatically selected as the default setting if no setting is manually selected Saline Pump This is a rotary peristaltic pump A special pump segment is attached to the saline delivery tubing of each Aquamantys disposable bipolar device which is designed to operate with the pump The pump segment is loaded into this Aquamantys Pump Generator pump head prior to operation of the device Always close the pump head prior to priming or device activation Always allow the pump head rotor to come to a complete stop prior to opening the pump head Do not attempt to load or adjust the positioning of the pump segment of the Aquamantys disposable bipolar device in the pump head while pump head rotor is turning Prevent fingers or loose clothing from being caug
6. 1 Error handling ERU iei rer iei ete tp pede p Ut ete dd tiene a dbi ids 8 1 MPUT Error G0des c 8 3 Testing and Servicing Safety eese aaa saaa aaa aa aa nennen nnne nnn nh inst ne sn itn niis inna a sets initis sn nnr inse nenne ennnen 9 1 Maintenance and Repalr 5 o n iei voye voee cocta un unike Gan ane 10 1 Responsibility of the Manufacturer ssssssssssssssssssssssseseeenn nennen enit neon innen saaa ooo se saaoooossessosoooosssssosooooooson 10 1 Routine Maintenance m aces 10 1 Returning the Aquamantys Pump Generator for Service ssesssssssseeene eene emm 10 7 Technical Specifications 5 au de k d aba ai soon kou ee en de eiit een et uae lead 00 lesen Sexe de aoa ee Ce Hees ds oco Co po ab SE Yasa adque A 1 Performance ChHaracteriStilS 23 2 2 konba kn p Lane desee kul e OK dates RP De Ende deae e te bin iine DE qoe epitet A 1 Standards and IEC Classifications i is naaar era en E an A a Ea Ena a EA Aa ren enne enn enne nennen nennen nnn enne A 3 Output Characteristics setuni d i i i a aiai de mad daea dreide ia iiia Hn A 4 ACCeSSOLIOS ioter n e HR ERR EE lay eee a DEDE E E D ier E ORG A 6 VWarranty2a Arsene x c paka n kwa Pan inkoni kon kaba a ke Zo B 1 List of Tables amp Figures Figure 2 1 Front Panel teu ee EE 2 1 Figure 2 2 Rear Panel uus dung vii td
7. 742 1515 outside the U S for further assistance 5 3 Section 6 After Surgery 6 1 Precautions Warnings Precautions Precautions This section contains information about Disposing of the Aquamantys Bipolar Device Preparing the Aquamantys Pump Generator for Reuse Transportation and Storing the Aquamantys Pump Generator Disposing of the Aquamantys Bipolar Device 1 Turn the Aquamantys Pump Generator off by pressing the bottom portion of the power switch marked 0 Firmly knot the saline delivery tubing between the drip chamber and the pump segment Open the pump head and remove the Aquamantys disposable bipolar device pump segment portion of the saline delivery tubing Remove the used saline bag from I V pole Disconnect the Aquamantys disposable bipolar device from the Pump Generator Dispose of the Aquamantys device and used saline bag according to the procedures for your institution The Aquamantys disposable bipolar device and the saline bag will contain unused saline following use of the device Take precautions to prevent the unused saline from flowing onto operating room surfaces by placing hand piece into waste receptacle prior to opening pump head and removing device pump segment Preparing the Aquamantys Pump Generator for Reuse Electric Shock Hazard Always turn off and unplug the unit before cleaning Do not clean the unit with abrasive cleaning or disinfectant compounds solvents
8. After Surgery krake se 3 3 Before SUFQOT Yea ewa kose tann ii ou kitan ap aaa 4 1 Quick Setup Instructions e nere tme RE access RAS e PU ert A A RA Sera een Le de Ere he EA 4 1 Setting Up the Aquamantys Pump Generator sse emen nennen eene nnne errem nennen nenne 4 1 Preparing Tor S rgety ai ak enn kai anti Deer nce sede HIE inei eo in Ee RR Feeds op dd a AP n RET LID anda MX a smekke 4 3 Connecting the Aquamantys Disposable Bipolar Device to the Aquamantys Pump Generator 4 3 Loading the Pump Segment Portion of the Aquamantys Device into the Pump Head c cecceceeeeeeeeeeeeeeeeees 4 3 SPIKING the Saline BAG wei E X benene 4 6 Priming the Aquamantys Disposable Bipolar Device ccecceceeeeeeeeeceeeeeeeeaee cece ata e onon tas aaa oooo sesasooosososaaoaoooooooan 4 7 Adjusting the RF Power Setting nitet nne Bo aaa vip E Hed ire dope gene ve eate eee ded ee ees idee epe bd sete 4 8 Adjusting the Saline Flow Rate eene ennemi nnne saaa ass tener ee nene entren nennen nennen nnn enne 4 9 During SUNG ORY Forel satset ee coed ma d enste rennene ea be AE nna n eeu E De s as cans ser aHa ERE de IR do de Na Re apse ke ake 5 1 Checking the Aquamantys Disposable Bipolar Device Connection sseseee eme 5 1 Chang
9. amber to indicate the current flow rate setting If a flow rate setting is not manually selected the medium setting is selected as the default setting The saline flow rate setting cannot be adjusted while the unit is being activated Figure 10 4 Adjusting the Flow Rate Setting Aquamant yj pare 10 4 10 5 Verifying Proper Pump Head Rotation Rate If it is open close the pump head by moving and locking the pump lever down toward the rear of the pump generator Remove the black rubber plug on the pump face which covers the pump shaft Mark a visual reference point near the outer circumference of the slotted end of the pump shaft using a felt tip marker or other means Set the Aquamantys Pump Generator power output to 200 watts and the flow rate to low Following the directions in the sections above manually activate the Aquamantys RF output Watching your reference marker on the slotted end of the pump shaft observe that the pump shaft rotates essentially evenly without binding or stalling Continuing to monitor your reference marker and using a stopwatch as a timer count the number of complete revolutions of the pump shaft in a period of 15 seconds Repeat for medium and high flow settings Specifications Table 10 2 Flow Rate vs Pump Shaft Revolutions Limits Flow Rate Setting Min Revs 15 sec Max Revs 15 sec Low 17 23 Medium 22 30 High 27 36 The flow rate regresses to zero mL min
10. and use new device Aquamantys disposable bipolar device pump is Ensure pump segment is aligned in the center of jammed by pump segment connector which has guide slots upside down v where it enters and inadvertently entered into pump head exits the pump head Source of normal saline is a non vented glass bottle Open vent cap on Aquamantys disposable bipolar device drip chamber Pump tubing segment not inserted correctly into Remove pump tubing segment from pump head pump head and reinsert correctly as indicated in User Guide Saline bag height below pump head Ensure saline bag is positioned at a height above the pump head Saline delivery tubing inserted into pump head Ensure black connector on the Aquamantys instead of pump tubing segment disposable bipolar device pump tubing segment is oriented to the left side of the pump head and the white connector to the right side of the pump head when pump tubing segment is inserted Air bubbles in line due to incorrect priming Press START PRIME button once to reprime technique the device in order to remove air bubbles Saline line kinked or compressed Ensure Aquamantys disposable bipolar device pump segment is properly aligned in the pump head Ensure saline line is not kinked compressed or occluded by OR equipment instruments or personnel Incorrect non Aquamantys disposable device Ensure device connected to Pump Generator is utilized an Aquamantys devi
11. appropriate manner by a certified disposal company Section 7 Troubleshooting This section contains information about General Troubleshooting Guidelines Troubleshooting Malfunctions Responding to Alarms General Troubleshooting Guidelines If the Aquamantys Pump Generator malfunctions first check for obvious conditions that may have caused the problem e Check the unit for visible signs of physical damage Make sure the fuse drawer is tightly closed Verify that all cords are connected and attached properly 7 1 Troubleshooting Malfunctions If a solution is not readily apparent use the table below to help identify and correct specific malfunctions After you troubleshoot the malfunction verify that the unit completes the self test as described in Section 4 Figure 7 1 Troubleshooting Situation Possible Cause Solution No power No saline when device activated 7 2 No power cord Wrong power cord utilized Use power cord shipped with Aquamantys Pump Generator or contact Salient Surgical Customer Service to obtain new power cord Use power cord shipped with Aquamantys Pump Generator or contact Salient Surgical Customer Service to obtain new power cord Faulty wall outlet Insert power cord into a functioning wall outlet Fuse drawer is open or fuses are blown Close the fuse drawer Replace the blown fuse s Refer to section 10 Wrong fuse Use fuse listed in secti
12. or any other muffling device over the loudspeaker Name Plate This plate specifies the model number serial number nominal line voltages frequency current and fuse rating information for the Aquamantys Pump Generator Fuse Drawer This fuse drawer contains two fuses Section 10 of this guide contains information for changing fuses Power Cord Receptacle This plug receptacle is used to connect the main power cord to the Aquamantys Pump Generator The power cord should only be connected to a source of power corresponding to that listed on the Name Plate Equipotential Grounding Lug Connector This lug connector is used to connect the Aquamantys Pump Generator to earth ground 2 3 Symbols Several symbols appear on the Aquamantys Pump Generator front panel rear panel and pump head Symbol inaicaes Symbol indicates ATTENTION Consult accompanying documents A Defibrillation Proof f Type CF Applied Part gt DANGER Explosion risk if used with flammable anesthetics To reduce the risk of electric shock do not remove the cover Refer servicing to qualified personnel A i Ap y High Equipotential grounding lug Medium Low Bipolar Device Attention A Caution IPX1 0123 CE Mark MM Pn TUV NRTL Mark START Do not discard in trash PRIME Electronic equipment should be disposed of in an appropriate manner
13. or other materials that could scratch the panels or damage the unit 1 Turn the Aquamantys Pump Generator off by pressing the bottom portion of the power switch marked 0 2 Unplug the main power cord from the wall outlet and receptacle on the Pump Generator Thoroughly wipe all surfaces of the unit and power cord with a damp cloth using a mild cleaning solution or disinfectant Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis The unit should not be sterilized Transportation and Storage of the Aquamantys Pump Generator Care should be taken when transporting the Aquamantys Pump Generator prior to and after use to prevent impact damage to the unit The unit should be transported on the Aquamantys Cart or a suitable alternative Consult the procedures for your institution and applicable regulations If the unit is stored at a temperature outside its normal operating range of 50 to 104 F 10 to 40 C allow it to stabilize at room temperature prior to use The unit can be stored indefinitely However if you store it longer than one year you must perform specific checkout procedures including functional verification before use Refer to section 10 of this guide Do not store the Aquamantys Pump Generator on its side or end This may cause damage to the unit Do not discard in trash Electronic equipment should be disposed of in an
14. saline that exits the electrodes as a result of the priming process If excess saline is not collected saline could drip on the patient patient drapes surgical instruments or operating room surfaces Lack of saline flow from both of the electrodes can result in a lack of tissue effect and may damage the electrodes during device activation Use caution to avoid the following conditions that can result in lack of adequate saline flow from the device Pump segment portion of the saline delivery tubing loaded improperly into the pump head In the wrong direction The black tubing connector should be to the left side of the pump head i e closest to the front panel of the Aquamantys Pump Generator Pinched pump segment portion Tubing not aligned in the center of the tubing guide slot Upper part of pump head not completely lowered onto the pump segment portion of the saline delivery tubing The upper part of the pump head must be completely lowered all the way down black lever rotated all the way to the right so that the pump head can properly interact with the pump segment portion of the saline delivery tubing Pump segment not loaded into the pump head at all Priming not completed START PRIME button not pressed START PRIME button pushed before the saline bag was spiked START PRIME button pressed a 2 time prior to priming cycle being completed 4 7 Warnings The START PRIME button activate
15. to conducted disturbances 10 Vrms 150 kHz 80 MHz Induced by RF fields power mains signallines DIN EN 61000 4 6 Voltage dips short interruptions Complies DIN EN 61000 4 11 Harmonic current emission Complies DIN EN 61000 3 2 class A Voltage fluctuation and flicker Complies DIN EN 61000 3 3 A 4 Output Characteristics Maximum Pump Generator Output Mode Maximum Maximum Short Maximum Crest Factor Open Circuit Current Power Circuit Arms Setting Voltage Watts Vpp V Bipolar 650 325 3 2 200 1 5 RF Output Output Power 20 to 200 watts Adjustable Power 5 watts from 20 to 100 watts Increments 10 watts from 100 to 200 watts Load Range 50 to 110 ohms Rated Load 100 ohms Output Waveform Bipolar 370 kHz sinusoid Saline Flow Rate Priming Flow Rate 36 mL min Priming Time 41 seconds Flow Rate 0 5 to 36 mL min depending on power setting and flow rate setting All specifications are valid for software version 1 11 and below All specifications are nominal and subject to change without notice Figure A 1 Output Voltage vs Power Setting Voltage Bipolar Vrms 20 40 60 80 100 120 140 160 180 200 Power Setting watts Power watts Saline Flow Rate cc min Output Power watts Figure A 2 Output Power vs Resistance 250 Bipolar Power 200 Watt Setting 200 Bipolar Power 100 Watt Se
16. using Specific instructions are not included in this manual Inspect the device and cord for breaks cracks nicks or other damage before every use Failure to observe this caution may result in injury or electrical shock to the patient or surgical team Set the RF power to the lowest setting before testing the device Connecting the Aquamantys Disposable Bipolar Device to the Aquamantys Pump Generator 1 Prepare the Aquamantys disposable bipolar device to be used for the procedure Refer to the Instructions For Use provided with the device 2 Connect the Aquamantys disposable bipolar device to the Aquamantys Pump Generator by directly inserting the plug of the device into the plug receptacle on the front panel of the Pump Generator Figure 4 1 Figure 4 1 Insert the device plug into the Aquamantys Pump Generator Loading the Pump Segment Portion of the Aquamantys Disposable Bipolar Device into the Pump Head of the Aquamantys Pump Generator Always close the pump head prior to priming or device activation Always allow the pump head rotor to come to a complete stop prior to opening the pump head Do not attempt to load or adjust the positioning of the pump segment of the Aquamantys disposable bipolar device in the pump head while the pump head rotor is turning Fingers or loose clothing could be caught in the pump rollers The saline delivery tubing of the Aquamantys disposable bipolar device includes a special p
17. 1 1726 CE 5 US Table of Contents gero EE GE EN EE een iv REI xoc V List OT FIGUES Lune EIER vi Tilt refo letto Pens 1 1 Indications for USE asiaani 1 1 Features insna e Aerie ei a one ne AE ea ee eee 1 2 Mudo IP 1 2 Simultaneous RF Power and Saline Delivery sess ennnne enne 1 2 Saline Flow Rate Setting e E 1 2 PANNO OE escrito eens event ane kan bon a RE deers 1 2 Controls Indicators and Receptacles r rvrrrrannrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenennnnennnnnnsnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnenennnnnnnunn 2 1 nj sne apestek eanet 2 4 Patient and Operating Room Safety rurnarnnnnvvnnnnnvnnnnnnvnnnnvnnnnnnvnnnnnnvennnnvnnnnnnvnnnnnnnnnnnennnnnnennnnnnennnnnnnnnnnnennnnennnnennnnnnnennnnnr 3 1 Generale 3 1 Confirm Proper Conriectioris eerte ere P ERE ERR E ERR Lr E er Re E RU eR irren En 3 1 POWEN CONAS e kenn ad UOEE 3 2 SOMVICING e it ea ELE 3 2 Before S rgery reed e Ue ede Pere etd sane pl deo excede SPE OEA deed ede ge oa d ete eed cious add eure deter sved 3 2 Du ririg SUrgely eh hrec ee ir mrt emitte dei Goda emen niteat 3 3 Do Not Use Other Non AquamantyS Devices ssessseeeenene nennen een enne enne nennen nene enn nenne 3 3
18. ALIENT SURGICAL TECHNOLOGIES INC MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED AS TO MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER IN NO EVENT SHALL SALIENT SURGICAL TECHNOLOGIES INC BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES THE ABOVE WARRANTY IS VOID ON ANY PRODUCT WHICH HAS BEEN MODIFIED OR REPAIRED OTHER THAN BY SALIENT OR AN AUTHORIZED REPRESENTATIVE IMPROPERLY INSTALLED USED MAINTAINED OR STORED OR SUBJECT TO ABUSE MISUSE NEGLECT OR ACCIDENT SALIENT IS NOT RESPONSIBLE FOR DAMAGE OR ANY OTHER LOSS DURING RETURN SHIPMENT B 1 This page intentionally left blank SALIENT SURGICAL TECHNOLOGIES Salient Surgical Technologies Inc 180 International Drive Portsmouth NH 03801 USA www salientsurgical com Customer Service Tel 866 777 9400 Fax 866 222 0900 Outside the U S 1 603 742 1515 1 603 742 1488 U K Telephone numbers Tel 0808 101 1727 Fax 0808 101 1726 Copyright 2005 2009 Salient Surgical Technologies Inc All rights reserved Printed in USA SALIENT the SALIENT LOGO AQUAMANTYS and the AQUAMANTYS LOGO are trademarks of Salient Surgical Technologies Inc Additional trademarks are the property of their respective owners 70 10 1358 RevA
19. AR Agua deba RR b us 2 1 Figure 4 1 Insert the Device Plug into the Aquamantys Pump Generator rrnrrnnnrnrrrnnrnnrnnnrrnnnnnnrrnnnnnnrrnnnnenrnn 4 3 Figure 4 2 Raising the Pump Head sasira aani aaeeea aaa eaen e aa aana aeaa na aoan raei adipa oaa iS 4 4 Figure 4 3 Placing the Pump Segment into the Pump Head rrnnrnnnrnnnnnnnrnnrnnnrnnnnnnnrnnnnnnrrnnnnnnrnnnnnnnerrnnnnnnrrnnnnennn 4 5 Figure 4 4 Lowering the Pump Head rmnrnnnnvvvnnnennnnnnnvennnonnnnennnnnnnnnnnnnnnvnnennnnnennnnennnennnnnennneennnnnnnennnneennnennnnnennneer 4 5 Figure 4 5 Proper Alignment of the Pump Segment in the Guide Slots rrrnnnrnnrrnnnrnrrrnrrnnrnnnrrnnnnnnrrnnnnnnrrnnnnenrn 4 6 Figure 4 6 Spiking the Saline Bag cccccecccceeeececeeeeeeneeeeeeaeeeeeeaaeeeesaeeeeesaeeeeesaaeeeeseaeeeeesaeeessseeeeeseneeeesseeeees 4 6 Figure 4 7 Initiating Priming of the Device sssssssssssssssssssseeseenenenerenn nnne nnemrten nnne nnne nennen nenne 4 7 Figure 4 8 Adjusting the RF Power Setting sssssssssssssssssssssseeseneee nennen enne nnne nnn n nennen 4 8 Figure 4 9 Adjusting the Saline Flow Rate ccccccceceececeeeeeceeeceeeeeeeeeeaeeeeeceaeeeeceaaeeeseeaaeeeseaeeeeseneeeeeseneeeeseneees 4 9 Table 7 1 Lro bleshootirig aus pe IL via Ced CIR Oe reed E C iet rd EU Me rec diaper re cie Eoo o rade 7 2 Table 8 1 Error Display eie e HER RU HEURE DA RE EKA LE RAP ARE RAD NIIS IRI 8 1 Table 8 2 Error C
20. CHNOLOGIES INC MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED AS TO MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER IN NO EVENT SHALL SALIENT SURGICAL TECHNOLOGIES INC BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES THE ABOVE WARRANTY IS VOID ON ANY PRODUCT WHICH HAS BEEN MODIFIED OR REPAIRED OTHER THAN BY SALIENT OR AN AUTHORIZED REPRESENTATIVE IMPROPERLY INSTALLED USED MAINTAINED OR STORED OR SUBJECT TO ABUSE MISUSE NEGLECT OR ACCIDENT SALIENT IS NOT RESPONSIBLE FOR DAMAGE OR ANY OTHER LOSS DURING RETURN SHIPMENT Refurbished Unit Warranty PLEASE NOTE For the refurbished Aquamantys Pump Generators Model numbers 40 401 1R 40 402 1R and the 40 403 1R the Limited Express Warranty described below replaces and voids the New Unit Limited Express Warranty found above LIMITED EXPRESS WARRANTY For six 6 months from the date of shipment from Salient if a refurbished Aquamantys Pump Generator is found to Salient s satisfaction to be inoperable during normal and proper use in accordance with applicable instructions Salient Surgical Technologies Inc will repair or replace the product at its sole option provided the product is returned freight prepaid in accordance with all return packaging and shipping instructions A product repaired or replaced under this warranty will be warranted for the remainder of the original warranty period S
21. It is recommended that the unit be switched off when it is not intended to be used for an extended period of time RF Power Indicator This indicator displays the power setting numerically in watts Additionally this indicator is used to display errors in which case the display will show Err and blink alternately with a special error code number s Aquamantys Disposable Bipolar Device Receptacle This plug receptacle is used to connect a 3 pin plug of an Aquamantys disposable bipolar device to the Aquamantys Pump Generator Start Prime Button This button activates and deactivates the timed priming cycle Pressing this button once automatically primes the Aquamantys disposable bipolar device with saline prior to use The pump will operate for a preset time period to prime the Aquamantys disposable bipolar device After the time period is complete the pump shuts off automatically Priming is required to avoid RF power activation without saline The Aquamantys disposable bipolar device is primed when saline drips from both electrodes of the device Failure to prime the device may result in RF power activation without saline Activation without saline may result in charring or damage to the electrodes of the device leading to a decrease in the hemostatic effectiveness of the device The START PRIME button activates and deactivates the timed priming cycle Pressing the button a second time will immediately stop the priming cycle
22. Pump Generator Aquamantys Q USER GUIDE e SALIENT Aquamantys Ke Pump Generator USER GUIDE Software Version 1 11 Foreword Precaution The Aquamantys Pump Generator is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment technology and techniques This manual is a guide for using the Aquamantys Pump Generator only Additional technical information is available in the Instructions For Use which accompanies individual Aquamantys disposable bipolar devices which are designed to be used as a part of the Aquamantys System Federal USA Law restricts this device to sale distribution and use by or on the order of a physician Equipment covered in this manual Aquamantys Pump Generator Nominal Salient Supply Voltage Model 100V 50 60Hz 40 401 1 115V 50 60Hz 40 402 1 230V 50 60Hz 40 403 1 100V 50 60Hz 40 401 1R 115V 50 60Hz 40 402 1R 230V 50 60Hz 40 403 1R For information call Salient Surgical Technologies Inc 180 International Drive Portsmouth NH 03801 USA www salientsurgical com Customer Service U S Telephone Numbers Tel 866 777 9400 Fax 866 222 0900 Outside the U S Tel 1 603 742 1515 Fax 1 603 742 1488 customerservice Qsalientsurgical com U K Telephone numbers Tel 0808 101 1727 Fax 0808 101 1726 WMDE Bergerweg 18 6085 AT Horn The Netherlands Tel 0808 101 1727 Fax 0808 10
23. ackup Pump Generator or traditional hemostatic techniques to complete the surgical procedure if repairs cannot be made prior to the scheduled surgical procedure See section 10 of this guide for maintenance schedule Pump Generator plugged into an inappropriate wall outlet e g not protected against ground fault etc Software or internal component malfunction Power setting is too low Malfunctioning Aquamantys disposable bipolar device or improper device connection Plug Pump Generator into an appropriate wall outlet prior to use Turn off and then turn on the unit If the error code reappears Record the error code number and refer to Responding to Alarms in this section Use a backup Pump Generator or traditional hemostatic techniques to complete the surgical procedure Increase the power Refer to Section 5 Changing the RF Power Setting Use the lowest possible power setting needed to obtain the desired surgical effect Turn off the unit Check the device connection If device continues to malfunction replace device and contact Salient Surgical to report device malfunction A malfunction condition exists Metal to metal sparking Electrically inconsistent ground wires in the operating room Faulty chassis to ground connections Monitor responding to radiated frequencies Metal to metal sparking Check the power display for an error code Note the code number and refer to Responding to A
24. ator power cord directly to a properly grounded receptacle which provides the appropriate electrical voltage and current Fire Hazard Do not use extension cords Always close the pump head prior to priming or device activation Always allow the pump head rotor to come to a complete stop prior to opening the pump head Do not attempt to load or adjust the positioning of the pump segment of the Aquamantys disposable bipolar devices in the pump head while the pump head rotor is turning Fingers or loose clothing could be caught in the pump rollers Do not stack equipment on top of the Aquamantys Pump Generator or place the generator on top of electrical equipment This may block access to the unit and not allow for proper ventilation Provide as much distance as possible between the Aquamantys Pump Generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Nonfunction of the Aquamantys Pump Generator may cause interruption of surgery A backup generator or alternative hemostatic techniques should always be available Warnings Precautions Warnings Precautions Warnings Warnings Precautions If required by your institution or applicable regulations connect the generator s equipotential lug connector to earth ground using a suitable cable Connect the main power cord directly to a properly grounded receptacle which provides the appropriate electrical v
25. ce Aquamantys logo on the side of the device If incorrect device is being utilized discard and utilize correct Aquamantys disposable bipolar device One or more of the saline slots in either of the Clean device electrodes with gauze Ensure electrodes of Aquamantys disposable bipolar device precautions are taken to avoid inadvertent device clogged by tissue or coagulated blood activation when cleaning device electrode If this does not correct the problem return device to Salient Surgical and use new device Aquamantys disposable bipolar device pump Insert pump tubing segment into pump head as segment is not inserted into pump head shown in User Guide 7 3 Generator doesn t work Unit is on but did not complete self test Unit is on and disposable device is activated but unit does not deliver output Interference with other device only when the unit is activated Continuous monitor interference Abnormal neuromuscular stimulation Stop surgery immediately 7 4 Pump Generator damaged Contact Biomedical Engineering Department ora Salient representative for assistance Use a backup Pump Generator or traditional hemostatic techniques to complete the surgical procedure if repairs cannot be made prior to the scheduled surgical procedure Pump Generator did not receive a scheduled safety check Contact Biomedical Engineering Department ora Salient representative for assistance Use a b
26. cedure prior to firmly knotting the saline delivery tubing between the drip chamber and the pump segment on the device Error codes appear Only activate the Aquamantys disposable bipolar device on over tissue intended to be treated Activation over another location may result in hot saline run off onto unintended tissue patient patient drapes hospital staff and operating room surfaces Ensure black connector on the Aquamantys disposable bipolar device pump segment is oriented to the left side of the pump head and the white connector to the right side of the pump head when pump tubing segment is inserted The Aquamantys disposable bipolar device and the saline bag will contain unused saline following use of the device Firmly knot the saline delivery tubing between the drip chamber and the pump segment on the device prior to opening the pump head Turn power off for a minimum of 10 seconds turn power back on If error code still displays contact Salient Surgical If problem persists after applying the appropriate solution indicated in this table use a backup pump generator or traditional hemostatic techniques to complete the surgical procedure Contact Salient Surgical Customer Service for assistance refer to section 10 of this guide Returning the Aquamantys Pump Generator for Service Section 8 Error Codes and Error Handling 8 1 The Aquamantys Pump Generator self test which is executed immediately following p
27. ct an Aquamantys disposable bipolar device to the Aquamantys Pump Generator by directly inserting the device into the plug receptacle on the front panel of the Pump Generator 5 Load the pump segment portion of the Aquamantys device saline delivery tubing into the pump head and close the pump head The black tubing connector on the pump segment should be positioned to the left side of the pump head and the white tubing connector should then be positioned to the right side of the pump head 6 Using aseptic technique remove the protective cover over the spike of the drip chamber at the end of the saline delivery tubing of the device and spike a bag of sterile saline 0 996 NaCI Select the RF power setting using the RF power setting buttons and RF power display Select the saline flow rate setting using the saline flow rate setting buttons and saline flow rate setting display 9 Press the START PRIME button The Priming Underway indicator will illuminate amber when priming is activated and thereafter shut off darken after priming The System is now ready for use Setting Up the Aquamantys Pump Generator Electrical Shock Hazard Connect the Aquamantys Pump Generator power cord to a properly grounded receptacle Do not use power plug adapters Fire Hazard Do not use extension cords Patient Safety Use the Aquamantys Pump Generator only if the self test has been completed as described in the Setting up the Aquamantys Pump Generato
28. e Table 10 1 Leakage Current and PE Conductor Limits Warnings Measured Characteristic Maximum Value PE conductor impedance 0 20 Earth leakage current normal condition 500 pA Earth leakage current single fault condition 1000 LA Housing leakage current normal condition 100 LA Housing leakage current single fault condition 500 pA Patient AC leakage current normal condition 10 pA Patient DC leakage current normal condition 10 pA Patient AC leakage current single fault condition 50 uA Patient DC leakage current single fault condition 50 uA RF leakage current The RF leakage current may be measured with the safety tester used in the previous leakage tests if that function is available If not it may be directly measured with a high frequency current sensing coil i e Pearson Electronics model 4100 a precision voltmeter and a noninductive 200 O load resistor The RF leakage is the current which flows from one side of the Aquamantys bipolar output socket through 200 O to the Aquamantys equipotential bonding terminal During this measurement the RF output must be active at the maximum power setting 200 watts Both outputs of the bipolar output Socket 4mm connector 1 and 4mm connector 2 should each be tested one at a time The RF leakage current should not exceed 100 mA In the absence of an Aquamantys bipolar disposable device the Aquamantys Pump Generator bipolar RF output may b
29. e manually activated by carefully shorting the 2mm banana style connector 1 to 4mm banana style connector 1 as shown in the following figure 10 1 High frequency high voltage signals are present on the output circuit when activated These signals can cause severe burns Extreme caution must be used when testing or troubleshooting the output of the pump generator 10 2 10 3 Warnings Precautions When 2mm connector 1 is shorted to 4mm connector 1 the Aquamantys bipolar RF output will be active from 4mm connector 1 to 4mm connector 2 Figure 10 1 Aquamantys Bipolar Output Socket RF Output Activation Short to Amm el Activate RF Output RF Output Power Accuracy Verification Load resistors used to test the output of the Aquamantys Pump Generator will become extremely hot Use extreme caution to avoid any contact All load resistors must be properly mounted and isolated from any flammable materials The RF power meter must have a current rating of at least 2 5 Arms Do not test the Aquamantys Pump Generator with a load of less than 50 ohms on the output RF currents in excess of 2 5 amps rms will occur It is preferable that these measurements be performed using an electrosurgical tester which is intended for this purpose however it is possible to perform this testing manually if required The manual method is achieved with a high frequency current sensing coil i e Pearson Electronics model 4100 a precisio
30. e stop prior to opening the pump head Prevent fingers or loose clothing from being caught in pump head rotors Verifying Proper Position of Pump Segment Guides e The Pump Segment Guides have been retrofitted with an insert to prevent inadvertent adjustment of the Pump Segment Guides This insert is intended to maintain the correct position of the Pump Segment Guides between the 2 and 5 position e Inthe event that there is no guide tab adjustment clip present another clip can be obtained from Salient Surgical Technologies Inc Please contact Salient Surgical Customer Service 866 777 9400 in the U S 0808 101 1727 in the U K 1 603 742 1515 outside U S for a replacement clip 5 Position gt mme e fitis essential that the Pump Generator be used prior to obtaining a replacement clip ensure that the Pump Segment Guides are located between the 2 and 5 position and that the pump segment tubing is loaded correctly Refer to the User Guide Generator Tray Quick Reference Guide for correct pump segment loading instructions 2 Position Figure 10 3 Guide Alignment Adjusting Flow Rate Setting The saline flow rate setting is adjusted by pressing the button next to the desired flow rate Figure 10 4 Flow rate options include e High saline flow rate High Medium saline flow rate Medium Low saline flow rate Low 4 The Flow Rate Setting Indicator next to the selected flow rate will be illuminated
31. edges or connector damage Check the power cord each time you use the unit or at intervals recommended by your institution Replace the power cord with an appropriate hospital grade replacement if any of these conditions or other evidence of damage exists Replacement power cords may be ordered from Salient Surgical Customer Service 866 777 9400 in the U S 0808 101 1727 in the U K 1 603 742 1515 outside U S Fuse check An internal component malfunction can damage the fuses You may need to replace the fuses if the unit stops functioning even though it is receiving power from a wall outlet Shock Hazard Turn off and unplug pump generator prior to accessing the fuse holder Check the rating of the fuses in the line filter on the rear of the Aquamantys Pump Generator for correct ratings To do so unplug the power cord from the generator Using a flat bladed screwdriver eject the fuse holder out of the line filter remove the microfuses and check for correct rating Table 10 3 Fuse Ratings Aquamantys type Operating voltage Fuse rating 40 401 1 100 V T5 0A 40 402 1 115 V T4 0A 40 403 1 230 V T2 0A 40 401 1R 100 V T5 0A 40 402 1R 115 V T4 0A 40 403 1R 230 V T2 0A If necessary replace the fuses with UL certified EN60127 fuses of the correct rating 10 6 10 7 Warnings Precautions Returning the Aquamantys Pump Generator for Service Before you return the unit call your Salie
32. ee possible flow rate settings Low Medium and High The three possible saline flow rates for each power setting are preset automatically in order to provide the optimal saline flow for a given power setting Priming The Aquamantys Pump Generator has a convenient one touch priming function which automatically primes the Aquamantys disposable bipolar device with saline prior to use after the device has been correctly connected to the unit This function is activated by pressing the START PRIME button on the unit The START PRIME button activates and deactivates the timed priming cycle Pressing the button a second time will immediately stop the priming cycle Pressing the button a third time will reset the timer and restart the priming cycle from the beginning Section 2 Controls Indicators and Receptacles This section contains information about the front and rear panels including all controls indicators receptacles and the fuse drawer Figure 2 1 Front Panel 10 N BIPOLAR 11 Figure 2 2 Rear Panel 2 1 Precautions Warning 2 2 Power On Off Switch The main power On Off switch is located at the bottom left corner of the front panel on the Aquamantys Pump Generator The unit is switched on by pressing the top portion of the switch marked The switch will be illuminated green when it is on The unit is switched off by pressing the bottom portion of the switch marked
33. eeeeseeaeeeeseeeeeeseneeeeseseeees A 4 Figure A 2 Output Power vs Resistance rmnrrnnrnnrrnnrrnnrrnnrnnnrnrnnnnnnnrnnnnnnrrnnnnnnrnnnnnnnrnnnnnrrnnnnnnrnnnnnnrrnnnnnnrrnnnnenenn A 5 Figure A 3 Saline Flow Rate vs Power Setting eene nnne nnne A 5 Figure A 4 Power Setting Characteristics at Rated Load rnnnnnnnnnnrnnrrnnnnnnrnnnrnnnnnnnrnnnnnnrrrrnnnnnnrnnnnnnnrnnnnenrrnnnnnnnnn A 5 vi Section 1 Introduction Indications for Use Warnings This section contains information about Indications for Use RF Power Simultaneous RF Power and Saline Delivery Saline Flow Rate Setting Priming The Aquamantys Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single use disposable bipolar devices for simultaneous delivery of radio frequency RF energy with saline for hemostatic sealing of soft tissue and bone at the operative site It is intended for but not limited to endoscopic and open abdominal orthopaedic spine and thoracic surgery The device is not intended for contraceptive tubal coagulation permanent female sterilization The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment technology and techniques The system is not intended for contraceptive tubal coagulation permanent female sterilization The system is not intended for cardiac or neurosurgical app
34. ent Surgical recommends that the unit s calibration be verified and a safety check be performed by a qualified biomedical technician on an annual basis as outlined below Recommended Functional Verification Procedure The verification and functional check should include Protective earth conductor test Earth leakage current measurement Housing leakage current measurement Patient leakage current measurement RF leakage current measurement at maximum power with no load Output power accuracy verification Peristaltic pump test function flow rate accuracy Testof visual indicators e Testof alarm tone and volume control function Power cord inspection for damage Fuse check Recommended test equipment Safety tester for medical units as per IEC 460601 RF power meter for RF surgery systems Stopwatch Leakage currents and protective earth conductor test The following connections should be established according to the safety tester s instructions Male end of Aquamantys Pump Generator s power cord into the safety tester mains socket e Aquamantys equipotential bonding terminal see section 2 item 17 for location to safety tester respective terminal Aquamantys bipolar output sockets to safety tester applied part terminals Perform leakage and PE conductor tests per the safety tester instructions The following limits must be complied with in accordance with IEC 60601 Class I Type CF devic
35. f test all front panel LEDs will illuminate momentarily and an audible test tone will sound 7 After the automatic self test is successfully completed after about 6 seconds the RF Power Indicator will display 20 watts 8 If the automatic self test is not successfully completed an alarm will sound the RF power output will be disabled and an error code will be displayed in the RF Power Indicator See the information below or refer to sections 7 and 8 of this User Guide if an error code appears 9 Ifthe display shows an alternating HP and Err following the self test the self test was executed while an Aquamantys disposable bipolar device was being activated Simultaneous activation of the device during the self test prevents the audio and visual indicators of the self test from occurring If this happens release the button on the device 10 If all LEDs do not illuminate or the audible test tone is not heard during the automatic self test turn the unit off and then turn the unit back on to cycle it through the self test If this does not resolve the problem do not attempt to use the Aquamantys Pump Generator and refer to sections 7 and 8 of this User Guide 4 2 4 3 Warnings Precautions Warning Preparing for Surgery Electric Shock Hazard Ensure that the device is correctly connected and that no metal is exposed Read the instructions warnings and precautions provided with the electrosurgical device before
36. ht in pump head rollers Precaution 10 11 12 13 Warning 14 15 16 17 Only the pump segment portion of the saline delivery tubing of the Aquamantys disposable bipolar device should be loaded into the pump head Use of any other portion of the saline delivery tubing of the device or any other tubing in this pump may damage the saline delivery tubing and or the pump Incorrect insertion of the pump segment may also result in RF power activation without saline Activation without saline may result in charring or damage to the electrodes of the device leading to a decrease in the hemostatic effectiveness of the device RF Power Setting Buttons These buttons control the RF power setting Press the A button to increase the RF power Press the V button to decrease the RF power RF Power Activation Indicator This indicator will illuminate blue when RF power is activated Aquamantys Quick Reference Guide Pullout Tray The Aquamantys Quick Reference Guide provides basic set up and operating instructions and illustrations for the Aquamantys System Loudspeaker Volume Control Knob This knob controls the volume of the tone that will sound when the RF power is activated RF power activation tone To increase the volume of the RF power activation tone turn the knob clockwise To decrease the volume of the RF power activation tone turn the knob counterclockwise The tone cannot be silenced Do not place adhesive tape
37. ice activation when cleaning device electrodes If this does not correct the problem return device to Salient and use new device Utilize appropriate suction to remove blood fluid and or saline See Aquamantys disposable bipolar device instructions for use and or device treatment guides for treatment recommendations Decrease the power Refer to Section 5 Changing the RF Power Setting Tissue over treated See Aquamantys disposable bipolar device Instructions For Use and or device treatment guides for treatment recommendations Non Aquamantys bipolar device utilized Saline flow rate setting too high Excess saline resulting from priming cycle Ensure device connected to Pump Generator is an Aquamantys device Aquamantys logo on the side of the device If incorrect device is being utilized discard and utilize correct Aquamantys disposable bipolar device Decrease saline flow rate Refer to Section 5 Changing the Saline Flow Rate Setting Place the device into a holster or over a container to collect the saline that will exit the electrodes as a result of the priming process 2nd or more activation of priming cycle Place the device into a holster or over a container to collect the saline that will exit the electrodes as a result of the priming process Off tissue device activation Saline delivery tubing inserted into pump head instead of pump tubing segment Pump head disengaged following pro
38. ile single use devices which employ RF energy and saline irrigation for hemostatic sealing and coagulation These devices are equipped with a dual electrode tip Saline and electrical lines exit the opposite end of the handpiece from the dual electrode The handpiece is equipped with an on off button that simultaneously activates both RF power and saline flow A saline fluid delivery line is provided with the device and includes a section of pump tubing and drip chamber The three pin electrical connector is designed to be plugged into the Aquamantys Pump Generator Electric Shock Hazard Ensure that the device is correctly connected Read the instructions warnings precautions and instructions provided with the Aquamantys disposable bipolar devices before using Specific instructions are not included in this manual Always set the RF power to the lowest setting to achieve the desired surgical effect Inspect each device and cord for breaks cracks nicks or other damage before every use Failure to observe this caution may result in injury or electrical shock to the patient or surgical team Aquamantys Pump Generator Patient Safety Use the Aquamantys Pump Generator only if the self test has been successfully completed as described in the section entitled Setting Up the Generator Inaccurate power outputs may result if the unit is operated prior to completion of the self test Electrical Shock Hazard Connect the Aquamantys Pump Gener
39. in a linear fashion so there is no need to verify the flow rate at lower power settings Verifying Flow Rate Accuracy of Priming Function The flow rate accuracy of the priming function should also be verified as follows Monitor the reference mark on the pump shaft as above and using a stopwatch as a timer press the prime switch Figure 10 5 to initiate the priming process Count the number of complete revolutions of the pump shaft in a period of 15 seconds There should be between 31 and 42 revolutions in 15 seconds Figure 10 5 Initiating the Priming Sequence Warnings The START PRIME button activates and deactivates the timed priming cycle Pressing the button a second time will immediately stop the priming cycle Pressing the button a third time will reset the timer and restart the priming cycle from the beginning Test of visual indicators During the power up self test of the Aquamantys Pump Generator verify that all visual indicators illuminate Test of alarm tone and volume control function Using manual procedure described in the RF Leakage Current section activate the bipolar output of the pump generator Verify that there is an audible activation tone Also verify that the volume of that tone can be adjusted but not turned down to an inaudible range with the volume control on the rear panel of the pump generator Power cord inspection Inspect the power cord for any signs of exposed wires cracks frayed
40. ing the RF Power Setting 2 ree eene tede de fa ad tenebant conde bd de dead an serere dede dae Pese a Pede e 5 1 Changing the Salirie Flow Rate Setting 2 eiie rtt etr npn nennt re Eos np aie Ree Rae ten e kk pd pa ak tann 5 2 Activating the AquamantyS System sss eene an aaa an aaa ee nene enr enne nnne nennen nene en nene entren nns 5 2 Adjusting the Volume of the Activation Tone nennen ennemi nnne enn en teneret nene enn rennes 5 3 Responding to Alarms seven iniecit e ate Etpe dec ea Les arene red Uaec e a uan eod Ete toe Pee dete o ser eee ene 5 3 After Surgery E 6 1 Disposing of the Aquamantys Bipolar Device sssseseeeeeenn emen ennemi enne nnne nns 6 1 Preparing the Aquamantys Pump Generator for Reuse sssssssseseeeenenen eene 6 1 Transportation and Storage of the Aquamantys Pump Generator ssssseeeemeeee en 6 1 LI T perire 7 1 General Troubleshooting Guidelines eiecit bnt centran spo b ait uon deeem se dn dap iden ba 7 1 Troubleshooting Ma lf nctlohs 5 pete tise edocet dienen Lee Dr tienen bet aedes esset De bandes pov ce oec pese egi od ga 7 2 Error codes and Error Handling esses eene enne nennen nnne nnne nn nnne tenth rint ne nie te nes en trien nnns sin nn nenene innen 8 1 Error display during the self test eene rer th nter eg rk tek MR ne enp SEEEN sen Aken nn na et 8
41. instructions prior to their use with the Aquamantys System In the event that a high electrosurgical power setting is required check all device connections cables and patient contacts before changing power settings If all connections cables and patient contacts are fault free then increase power settings in small increments checking carefully after each change Always close the pump head prior to priming or device activation Always allow the pump head rotor to come to a complete stop prior to opening the pump head Do not attempt to load or adjust the positioning of the pump segment of the Aquamantys disposable bipolar device in the pump head while pump head rotor is turning Prevent fingers or loose clothing from being caught in pump head rotors 1 1 Precautions Precaution Use the Aquamantys System with caution in the presence of pacemakers as electrosurgical equipment may cause interference with pacemakers or other active implants Read all warnings precautions and instructions provided with the Aquamantys Pump Generator before using Read the warnings precautions and instructions provided with Aquamantys disposable bipolar devices before using Specific instructions are not included in this manual Special care should be taken when using the Aquamantys System in the proximity of neural tissue It is recommended that physicians utilize pre clinical training review of pertinent literature and other appropriate educat
42. ional tools before attempting newer surgical procedures such as endoscopic laparoscopic or thoracoscopic procedures Position the Aquamantys Pump Generator away from life supporting and or monitoring systems to reduce avoid interference with these systems Ifthe RF Surgical unit fails an unwanted increase of the output power could be the result Features Simultaneous RF power and saline delivery Power settings from 20 200 watts Automatic settings for saline flow rate based on power setting Ability to select three different flow rate settings e Convenient priming mode RF Power The Aquamantys Pump Generator delivers bipolar RF power with power settings in 5 watt increments in the range of 20 to 100 watts and 10 watt increments in the range of 100 to 200 watts At higher tissue resistances the unit senses the high resistance and reduces the RF power output independent of the front panel setting to a level which prevents arcing or cutting Simultaneous RF Power and Saline Delivery The Aquamantys Pump Generator simultaneously delivers RF power and saline to an Aquamantys disposable bipolar device when the device is properly connected to the unit and the activation button on the device is depressed The Pump Generator is for use only with Aquamantys single use disposable bipolar devices Saline Flow Rate Setting The saline flow rate setting is determined based on the power setting and the selection of one of thr
43. larms in this section Check all connections to the unit and device Verify that all ground wires are as short as possible and go to the same grounded metal Check and correct the chassis ground connections for the monitor and for the unit Check other electrical equipment in the room for defective grounds If not resolved contact Biomedical Engineering Department to check with the monitor manufacturer Check all connections to the unit and devices Situation Ineffective hemostasis Unintended tissue effect Excessive saline Error codes Possible Cause Power setting too low Tissue under treated Tissue not treated long enough to result in a reduction in intraoperative or postoperative blood loss Wrong fluid used for device irrigation Electrode s of Aquamantys disposable bipolar device clogged by tissue or coagulated blood Excessive blood fluid or saline in surgical field where device is being utilized Power setting too high Solution Increase the power Refer to Section 5 Changing the RF Power Setting Use the lowest possible power setting needed to obtain the desired surgical effect See Aquamantys disposable bipolar device Instructions For Use and or device treatment guides for treatment recommendations Only utilize sterile bag of sodium chloride solution 0 9 NaCl with the Aquamantys System Clean device electrodes with gauze Ensure precautions are taken to avoid inadvertent dev
44. lications Do not activate the device unless saline is flowing and it is in contact with tissue to be treated If saline flow stops during the electrosurgical procedure stop using the Aquamantys disposable bipolar device and attempt to resume saline flow Ensure that the saline source is adequate and the saline delivery system is functioning properly If unable to resume saline flow discontinue use and return the device to Salient Surgical and use another Aquamantys disposable bipolar device or replace the Aquamantys Pump Generator Surgery should be performed by persons with adequate training and preparation Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation DO NOT use electrosurgery in the presence of flammable anesthetics or other flammable gases near flammable fluids or objects or in the presence of oxidizing agents as fire could result Examine the Aquamantys disposable bipolar device before connecting it to the Aquamantys Pump Generator After connecting the device ensure that device and unit are functioning as intended The cable on the Aquamantys disposable bipolar device should be positioned in a way to avoid contact with the patient or other cables Consult the operating and user manuals for light sources and other ancillary devices for warnings precautions and
45. lization connector with an equipotential cable Connect the power cord to a properly grounded receptacle having the correct voltage Otherwise product damage may result 1 Ensure the power switch for the Aquamantys Pump Generator is in the off position by pressing the bottom portion of the power switch marked O 2 Place the Aquamantys Pump Generator on an Aquamantys Cart If you do not have an Aquamantys Cart place the Aquamantys Pump Generator on a flat stable surface such as a table or other suitable platform Consult the procedures for your institution and applicable regulations 3 Provide at least six inches of space around the sides and top of the Aquamantys Pump Generator for access to the controls displays and receptacles and to provide for air cooling of the unit The top sides and rear panel of the Pump Generator may become warm when the Aquamantys Pump Generator is used in a normal manner 4 Connect the Aquamantys Pump Generator main power cord directly into the power cord receptacle on the rear panel 5 Connect the Aquamantys Pump Generator main power cord directly into a properly grounded receptacle to provide the appropriate electrical voltage and current 6 Turn the Aquamantys Pump Generator on by pressing the top portion of the power switch marked Upon Pump Generator start up the unit will perform an automatic self test Prior to the self test the software version will be displayed During the sel
46. ly one device can be connected at any one time Changing the RF Power Setting Confirm proper power setting before proceeding with surgery Use the lowest setting possible to achieve the desired tissue effect Inspect the device and cord for breaks cracks nicks or other damage before every use Failure to observe this caution may result in injury or electrical shock to the patient or surgical team Press the A button to increase the RF power Press the V button to decrease the RF power 5 1 5 2 Precautions Warnings Precautions The RF power setting changes in increments of 5 watts in the range of 20 to 100 watts and in increments of 10 watts in the range of 100 to 200 watts If either button is held down the setting will change slowly then more rapidly Release the button when the desired RF power setting is displayed An alarm tone will sound when the power reaches 200 watts and when it is lowered to 20 watts The RF power setting cannot be adjusted while the Aquamantys disposable bipolar device is being activated Changing the Saline Flow Rate Setting Using the low flow rate setting at the high power setting may result in more steam production at the electrodes than with the medium or high flow rate settings and may result in electrode charring or damage with reduced hemostatic effectiveness Set the saline flow rate setting by pressing the button next to the desired flow rate Flow rate options include A
47. n test sense line negative pulse 023 044 023 045 Handpiece detection test open test sense line positive pulse Handpiece detection test diode test line negative pulse 023 046 Handpiece detection test diode test line positive pulse 023 050 Command error Section 9 Testing and Servicing Safety Warnings Precautions Shock Hazards Contact a Salient Surgical service professional for all assembly operations readjustments modifications or repairs Routine maintenance and functional verification can be performed by a qualified biomedical technician as set forth in section 10 Routine Maintenance The Aquamantys Pump Generator power cord must be connected to a properly grounded receptacle during normal use or testing Burn Hazards High frequency high voltage signals are present on the output circuit when activated These signals can cause severe burns Extreme caution must be used when testing or troubleshooting the output of the pump generator Load resistors used to test the output of the pump generator will become extremely hot Use extreme caution to avoid any contact All load resistors must be properly mounted and isolated from any flammable materials The Aquamantys Pump Generator power cord must be connected to a properly grounded receptacle during normal use or testing Do not use extension cords or adapter plugs All warnings and precautions accompanying the Aquamanty
48. n voltmeter and 200W noninductive load resistors of appropriate resistive values The delivered power will be calculated as I R Also manual RF output activation as described above will be required The RF output should be tested at both 100 watt and 200 watt settings with the output loaded at 50 ohms 100 ohms and 150 ohms At 50 ohm and 100 ohm loads the measured RF output power should be equal to the set power 20 At the 150 ohm load the measured RF power should be less than that measured at 100 ohms The object is to compare the measured output power for any given load to the output power vs resistance curve in the Technical Specifications section of this manual applying a tolerance of 20 Adjusting the RF Power Setting Press the A button to increase the RF power and press the V button to decrease the RF power Figure 10 2 The RF power setting changes in increments of 5 watts in the range of 20 to 100 watts and in increments of 10 watts in the range of 100 to 200 watts Release the button when the desired RF power setting is displayed An alarm tone will sound when the power reaches 200 watts and when it is lowered to 20 watts The RF power setting cannot be adjusted while the unit is being activated Figure 10 2 Adjusting the RF Power Setting Warnings Peristaltic pump test function flow rate accuracy Always close the pump head prior to activating pump motor Always allow the pump head rotor to come to a complet
49. nctioning of pump motor 4 First insure pump head rotor is not jammed and then check proper functioning of pump motor MPU1 Error Codes When an error code 023 is encountered during the self tests described in the table above the display sequence is reallocated for a subset of error codes specific to MPU1 errors The power setting display will still repeatedly sequence through three displays but the first display is Err followed by 023 to indicate the primary error number followed by the unique MPU1 error code Table 8 3 MPU1 Error Display Display Description Display format Err Err Primary Error Code 023 MPU1 Error Code XXX Table 8 4 MPU1 Error Code Description Error No 023 001 Brief Description CRC check error Checked During Use 023 002 RAM test error 023 003 CRC check error 023 004 Watchdog error 023 005 Local IC BUS errors EEPROM 023 006 Controller IC BUS error 023 007 uController defective 023 008 Software inconsistency 023 009 023 010 5 V AD converter or reference voltage error 15V error 023 011 15V error 023 012 Ground AD converter error 023 013 Relay test 023 014 Mutual time monitoring of MPUs 023 020 Power watch and power compensation error 023 042 Temperature outside of tolerance 023 043 Handpiece detection test ope
50. ndicates which side of pump the indicates which side of pump the white connector on pump segment black connector on pump segment should be positioned should be positioned White connector on the right side of pump head Black connector on the left side of pump head 3 Use the black tipped lever to close the pump head Rotate the black tipped lever 180 degrees clockwise from the left side of the pump head to the right side of the pump head This action will lower the upper part of the pump head Figure 4 4 Precaution Do not peel saline delivery segment apart from the device cable before placing the pump segment in the pump head Peeling the tubing first increases the potential for loading the pump segment in the reversed position Figure 4 4 Lowering the pump head 4 At the locations where the tubing enters and exits the pump head the upper moving part of the pump head includes black slotted tubing guides Ensure that the pump segment portion of the saline delivery tubing is properly aligned in the pump head by inspecting where the tubing enters and exits the pump head The pump segment must be centered in the guide slot of both tubing guides with no pinching of the tubing This is shown in Figure 4 5 4 5 Figure 4 5 Proper alignment of the pump segment portion of the saline delivery tubing in the left and right guide slots of the tubing guides Ensure pump segment is aligned in the center of guide slots upside down v
51. nings precautions and instructions provided with the Aquamantys Pump Generator before using Read the instructions warnings and precautions provided with Aquamantys disposable bipolar devices before using Specific instructions are not included in this manual Quick Setup Instructions If you are familiar with the Aquamantys Pump Generator you may prefer to follow the quick setup instructions below This information is also available in the Aquamantys System Quick Reference Guide printed on the pull out tray located below the front panel of the Pump Generator If you are not familiar with the Aquamantys Pump Generator setup procedure detailed setup instructions follow this section 1 Ensure the power switch for the Aquamantys Pump Generator is in the off position by pressing the bottom portion of the power switch marked O Connect the unit s main power cord into the power cord receptacle on the rear panel 2 Connect the Aquamantys Pump Generator main power cord directly into a properly grounded receptacle to provide the appropriate electrical voltage and current 3 Turn the Aquamantys Pump Generator on by pressing the top portion of the power switch marked i Upon Pump Generator start up the unit will perform an automatic self test During the self test all front panel LEDs will illuminate momentarily and an audible tone test will sound Wait for the self test to be successfully completed before utilizing the unit 4 Conne
52. ns are not included in this manual Do not continuously activate the Aquamantys System for extended periods of time Extended activation could potentially overheat the Pump Generator and increase risk of device malfunction or fire hazard Do not use the Aquamantys disposable bipolar device in an immersed setting e g arthroscopic surgery Use in an immersed setting could potentially overheat the Pump Generator and increase the risk of device malfunction or fire hazard Only activate the Aquamantys disposable bipolar device on tissue intended to be treated Activation over another location may result in hot saline run off onto unintended tissue patient patient drapes hospital staff and operating room surfaces Use caution to prevent inadvertent activation of the Aquamantys disposable bipolar device during the procedure Inadvertent activation may result in injury to the patient or surgical team Checking the Aquamantys Disposable Bipolar Device Connection Do not wrap device cords around metal objects This may induce currents that could lead to shocks fires or injuries to the patient or surgical team Inspect the Aquamantys disposable bipolar device and cord for breaks cracks nicks or other damage before every use Failure to observe this caution may result in injury or electrical shock to the patient or surgical team Confirm that the Aquamantys disposable bipolar device is properly connected to the Aquamantys Pump Generator On
53. nt Surgical representative for assistance If you are instructed to send the unit to Salient Surgical first obtain a Return Goods Authorization Number and then ship the unit to Salient Surgical for service The unit should be cleaned prior to shipping and shipped in appropriate packaging which protects the unit from damage see below Step 1 Obtain a Return Goods Authorization Number Call the Salient Surgical s Customer Service at 866 777 9400 1 603 742 1515 outside the U S 0808 101 1727 in the U K to obtain a Return Goods Authorization Number Have the following information ready when you call Hospital clinic name customer number Telephone number Department street address city state or province if applicable zip postal code and country if outside the U S Model number Serial number Description of the problem e Type of repair to be done if known Step 2 Clean the Unit Electric Shock Hazard Always turn off and unplug the unit before cleaning Do not clean the unit with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the unit 1 Turn off the unit and unplug the power cord from the wall outlet 2 Thoroughly wipe all surfaces of the unit and power cord with a damp cloth using a mild cleaning solution or disinfectant Follow the procedures approved by your institution or use a validated infection control procedure Do not all
54. ntended thermal damage to tissue Do not attempt to alter device configurations or replace device components with nonstandard parts since this may result in decreased device performance device malfunction or patient injury Confirm Proper Connections Before using any electrosurgical equipment confirm the following The power cable on the Aquamantys disposable bipolar device is properly connected to the Aquamantys device receptacle on the front panel of the Aquamantys Pump Generator All electrical connections are tight clean and dry All fluid connections are secure 3 1 3 2 Warnings Warnings Precautions Warnings Precautions Warnings Precautions Power Cords Do not wrap power cords around metal objects This may induce currents that could lead to shock fire or injury to the patient or surgical team All power cords should be positioned in a way to avoid contact with the patient or other cables Servicing Electric Shock Hazard Do not remove the Pump Generator bottom cover Removal of the bottom cover voids any warranty Contact authorized personnel for service The Aquamantys Pump Generator should only be serviced by a qualified personnel according to your hospital s capital equipment servicing guidelines Salient Surgical recommends that the unit be verified and undergo a functional check by a qualified personnel on an annual basis Before Surgery Aquamantys Disposable Bipolar Devices are ster
55. ode Descriptions a e a a a arr ra a ra aaar nae rr aaa aaa a aer raa earra eaae roai sa rennes 8 2 Table 8 3 MPU1 Error Display ea a ar aT e A a r a e a a ae a E ar a a a E aa E eaea nnns nennen 8 3 Table 8 4 MPU1 Error Code Description arnrrnnrnnrrnnronnnrnnrnn nn aaa t aaa aaa asse ooo astaaoo eseaooo ssasoooosesonooesesoooresesoooosesonn 8 3 Table 10 1 Leakage Current and PE Conductor Limits errnnnnnnnnnnrnnnrnnrnnnrrnnnnnnrnnnnnnnnrnnnnnnrrnnnnnnrnnnnnerrnnnnnnnennnn 10 2 Figure 10 1 Aquamantys Bipolar Output Socket RF Output Activation cccccceeeeeceeeeeeeeeeeeeeeeeeeeseeeeseseeees 10 3 Figure 10 2 Adjusting the RF Power Setting ccccccccceeeeeceeeeeeeeeeeeeeeeceeeeceaeeeeeeaeeeeseaeesesscaeeeseseaeeeeesneeeeenaees 10 3 Figure 10 3 Guide Insert Alignment ccccccccceeeeeeeeeeeecaeeeeeeeeeeeeecaaeeeeeaeeeeeeaaeeeeecaaeeeeecaaeeesecaeeeesscaeeeeesseeeteeeaees 10 4 Figure 10 4 Adjusting the Flow Rate Setting cccccccccceeeecceeeeeeeeeeeeeeeeceeeecaeeceseaeeeeseaeeeesecaeeeeeecaeeeeeseeeteesaees 10 4 Table 10 2 Flow Rate vs Pump Shaft Revolutions Limits 10 5 Figure 10 5 Initiating the Priming Sequence ccccccccceeeeeceeeeeeeeeeeeeeeeeeeeeeaeeeeeeaaeeeeeeaaeeeeecaeeeesenaeeeessneeeeesaees 10 5 Table 10 3 Fuse Ratings Aa sa dnne LA SE ANS 10 6 Figure A 1 Output Voltage vs Power Setting ccccccccceeceeceeeeeeeeeeeeeeeeceeeecaeeceseaaeeeeeca
56. oltage and current Otherwise product damage may result Priming is required to avoid RF power activation without saline The Aquamantys disposable bipolar device is primed when saline drips from both electrodes of the device Failure to prime the device may result in RF power activation without saline Activation without saline may result in charring or damage to the electrodes of the device leading to a decrease in the hemostatic effectiveness of the device During Surgery Aquamantys Pump Generator Power Settings Confirm the Aquamantys Pump Generator is set to the lowest RF power setting to achieve desired effect Always use the lowest RF power setting to achieve the desired surgical effect Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when a device is active Aquamantys Disposable Bipolar Devices Contact between the active electrodes and any metal will greatly increase current flow and can result in unintended catastrophic burn injury Fire Hazard Do not place a device near or in contact with flammable materials Electrosurgical devices that are activated can cause a fire When not using the device place it in a holster or in a clean highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns Aquamantys disposable bipolar devices are for use only with the Aquamantys Pump Generator Use of these devices with other elect
57. on 10 of this guide Correct fuse is also listed on back panel of the unit Unit not turned on Switch unit on using the power switch located on the front panel of the unit Insufficient insertion of device plug into receptacle Insufficient insertion of power cord into unit or wall jack Ensure Aquamantys disposable bipolar device is fully inserted into device plug receptacle Ensure power cord is fully inserted into back of unit and wall jack Damaged Aquamantys Pump Generator power cord Contact Salient Surgical Customer Service to obtain a new power cord Damaged Aquamantys disposable bipolar device power cord Pump tubing segment not inserted correctly into pump head Do not use device Return the device to Salient Surgical and use new device Remove pump tubing segment from pump head and reinsert correctly as indicated in User Guide Saline bag positioned on side or upside down Pump head not closed Ensure saline bag is positioned right side up Close the pump head prior to use No saline source Ensure spike at end of device tubing set is correctly inserted into a 250 ml or larger I V bag of sodium chloride solution 0 996 NaCI Priming cycle not completed Priming button on unit pressed before the saline bag was spiked Press START PRIME button once and ensure priming cycle completes and saline drips from both electrodes of the device Press START PRIME button
58. once and ensure priming cycle completes and saline drips from both electrodes of the device Inadequate supply of saline Replace used bag of sodium chloride solution 0 9 NaCl with a new bag No saline when device activated continued Incorrect saline flow when device activated Pump tubing segment inserted in reverse Ensure black connector on the Aquamantys orientation disposable bipolar device pump tubing segment is oriented to the left side of the pump head and the white connector to the right side of the pump head when pump tubing segment is inserted Saline line kinked compressed occluded Ensure Aquamantys disposable bipolar device pump segment is properly aligned in the pump head Ensure saline line is not kinked compressed or occluded by operating room equipment instruments or personnel Non Aquamantys bipolar device connected to Pump Ensure device connected to Pump Generator is Generator an Aquamantys device Aquamantys logo on the side of the device If incorrect device is being utilized discard and utilize correct Aquamantys disposable bipolar device All saline slots in either electrodes of the Clean device electrodes with gauze Ensure Aquamantys disposable bipolar device clogged by precautions are taken to avoid inadvertent device tissue or coagulated blood activation when cleaning device electrodes If this does not correct the problem discontinue use and return device to Salient Surgical
59. ow fluids to enter the chassis The unit cannot be sterilized Step 3 Ship the Unit 1 Attach a tag to the unit that includes the Return Goods Authorization Number and the information hospital phone number etc listed in Step 1 Obtain a Return Goods Authorization Number 2 Besure the unit is completely dry before you pack it for shipment Package it in its original shipping container if available If the original shipping container is not available contact Salient Surgical Customer Service at 866 777 9400 outside U S 1 603 742 1515 in the U K 0808 101 1727 Follow the shipping instructions provided while obtaining the Return Goods Authorization number Appendix A Technical Specifications Performance Characteristics General Output Configuration Isolated output Cooling Internal fan natural convection on outside of chassis Display Three 3 digital seven segment displays 0 55 inches 1 4 cm each Dimensions and Weight Width 12 2 inches 31 0 cm Depth 15 2 inches 38 5 cm Height 5 9 inches 15 0 cm Weight 31 5 Ibs 14 3 kg Operating Parameters Ambient temperature range 50 to 104 F 10 to 40 C Relative humidity 15 85 non condensing Air pressure 524 795 mmHg 700 to 1060 hPa Transport and Storage Ambient temperature range 29 to 149 F 34 to 65 C Duty Cycle At maximum output settings 200 Watts and rated load conditions 100 Ohms the unit may be safely opera
60. ower up comprises several phases The first phase covers the internal RAM and the MPUO watchdog test The second phase tests the major computer hardware components microcontroller The third phase tests the NV RAM and the separate RFGEN modules for potential errors Portions of this self test are repeated in the background during normal use see Checked During Use column of Error Code Description Table If an error is detected the respective test is repeated at least once in order to exclude sporadic deviations If the deviation remains the self test aborts an error message is generated and the unit enters the safe state The safe state disables all functions of the pump generator until the error condition is cleared Error display during the self test While in the safe state following the detection of a self test error the power setting display will repeatedly sequence through three displays The first display is Err followed by the error number followed by the measured value Table 8 1 Error Display Display Description Display format Err Err Error Code Number XXX Measured value XXX Error handling As a first response to an error indication it is recommended to turn the power off to the unit wait for approximately 10 seconds and then turn it on again to repeat the self test Error No Table 8 2 Error Code Descriptions Brief description CRC check error Checked During Use Remarks
61. r section of this guide Using the unit prior to completion of the self test may result in inaccurate power output Always close the pump head prior to priming or device activation Always allow the pump head rotor to come to a complete stop prior to opening the pump head Do not attempt to load or adjust the positioning of the pump segment of the Aquamantys device in the pump head while the pump head rotor is turning Fingers or loose clothing could be caught in the pump rollers Precautions Do not stack equipment on top of the Aquamantys Pump Generator or place it on top of electrical equipment These configurations are unstable and or do not allow for proper ventilation Provide as much distance as possible between the Aquamantys Pump Generator and other electronic equipment such as monitors When activated the Aquamantys Pump Generator may cause interference with this equipment Failure to place the Aquamantys Pump Generator on a suitable table cart or Surface may result in instability and increased risk for damage to the Pump Generator due to impact damage Nonfunction of the Aquamantys Pump Generator may cause interruption of surgery A backup generator or alternative hemostatic techniques should always be available Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when a device is active If required by local codes connect the Aquamantys Pump Generator to the hospital equa
62. rosurgical generators could result in injury to the patient or surgical team or cause damage to the device and or the generator Use of suction too close to the electrodes while the device is activated may remove saline flow that is needed for proper device function and result in activation without sufficient saline which may char or damage the instrument Do Not Use Other Non Aquamantys Devices The Aquamantys Pump Generator is for use with Aquamantys disposable bipolar devices only Refer to the Instructions For Use IFU which accompanies the device to confirm that it indicates that the device is compatible with the Aquamantys Pump Generator A listing of Aquamantys Pump Generator compatible disposable bipolar devices is also included in Salient Surgical s Product Catalog Use of non Aquamantys devices could result in injury to the patient or surgical team or cause damage to the device and or the Pump Generator After Surgery Electrical Shock Hazard Always turn off and unplug the Aquamantys Pump Generator before cleaning Do not clean the Aquamantys Pump Generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the unit Use a mild cleaning solution or disinfectant with a damp cloth 3 3 Section 4 Before Surgery 4 1 Precautions Warnings This section contains information about preparing the Aquamantys Pump Generator for surgery Read all war
63. rsonnel DANGER Explosion risk if used with flammable anesthetics Class I Equipment Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor Type CF Equipment Defibrillator Proof This unit provides a high degree of protection against electric shock particularly regarding allowable leakage currents It is type CF isolated floating output IPX1 Drip Proof This unit enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wet are likely to affect adversely the safety of the unit Electromagnetic Compatibility The Aquamantys Pump Generator meets the electromagnetic compatibility requirements of IEC60601 1 2 2001 Immunity Test IEC 60 601 1 2 2001 Test Level Conducted emission 150 kHz 30 MHz DIN EN 55011 FCC Part 18 Class B consumer class Radiated emission 30 MHz 1 GHz DIN EN 55011 FCC Part 18 Class B non consumer class Electrostatic discharge t 6 kV Contact discharge DIN EN 61000 4 2 8 KV Air discharge Immunity to electromagnetic fields 10 V m DIN EN 61000 4 3 80 2500 MHz Immunity to conducted fast transients Burst DIN EN 61000 4 4 2 kV power mains 1 KV signallines t Immunity to conducted slow transients Surge 1 2 50us DIN EN 61000 4 5 X 2 KV unsym t 1 kV sym power mains Immunity
64. s Pump Generator should be read and understood prior to attempting any testing or servicing of the unit When performing accuracy measurements keep all leads as short as possible and keep leads away from metallic surfaces Observe stated duty cycle when testing or servicing unit The Aquamantys Pump Generator is not intended for continuous activation for extended periods of time 9 1 Section 10 Maintenance and Repair 10 1 This section contains information about Routine maintenance Returning the Aquamantys Pump Generator for service Responsibility of the Manufacturer Salient Surgical is responsible for the safety reliability and performance of the Aquamantys Pump Generator only under the following circumstances Installation and setup procedures in this manual are followed Assembly operation readjustments modifications or repairs are carried out by persons authorized by Salient Surgical Technologies Inc The Pump Generator is connected to electrical wiring which complies with local codes and regulatory requirements The equipment is used in accordance with the Aquamantys System instructions for use For warranty information refer to the Warranty at the end of this guide Routine Maintenance Recommended Periodic Functional Verification The Aquamantys Pump Generator should be periodically checked for functionality and performance according to your hospital s equipment servicing guidelines Sali
65. s and deactivates the timed priming cycle Pressing the button a second time will immediately stop the priming cycle Pressing the button a third time will reset the timer and restart the priming cycle from the beginning Pressing the START PRIME button more than once will result in additional saline being delivered to the device Always place the device into a holster or over a container to collect the saline that will exit the electrodes as a result of the priming process Keep fingers clear when lowering the pump head to avoid pinching fingers along with the pump segment Adjusting the RF Power Setting Always use the lowest setting possible to achieve the desired tissue effect 1 Set the RF power shown in Figure 4 8 Press the A button to increase the RF power Press the V button to decrease the RF power The RF power changes in increments of 5 watts in the range of 20 to 100 watts and in increments of 10 watts in the range of 100 to 200 watts If either button is held down the setting will change slowly then more rapidly Release the button when the desired RF power setting is displayed An alarm tone will sound when the power reaches 200 watts and when it is lowered to 20 watts The RF power setting cannot be adjusted while the Aquamantys disposable bipolar device is being activated Figure 4 8 Adjusting the RF Power Setting 4 8 4 9 Adjusting the Saline Flow Rate 1 Adjust the saline flow rate setting by pres
66. sence of RF power output At maximum output settings 200 Watts and rated load conditions 100 Ohms the Aquamantys Pump Generator may be safely operated for activation times of 40 seconds on 80 seconds off for 1 hour With reduced power settings the unit can be activated for greater durations without generating excess internal temperatures Precautions Adjusting the Volume of the Activation Tone Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when a device is active To change the volume of the RF power activation tone turn the volume control knob on the rear panel of the Aquamantys Pump Generator To increase the volume of the RF power activation tone turn the knob clockwise To decrease the volume of the RF power activation tone turn the knob counterclockwise The Pump Generator prevents this tone from being silenced Responding to Alarms When the Aquamantys Pump Generator senses a malfunction a series of alarm tones will sound and the RF power is disabled Additionally the RF Power Indicator will show Err and blink alternately with a special error code number s 1 Turn the Aquamantys Pump Generator off by pressing the bottom portion of the power switch marked 0 2 After 10 seconds switch the unit on by pressing the top portion of the power switch marked and verify that the self test is successfully completed During the self test all fron
67. sing the button next to the desired flow rate This is shown in Figure 4 9 Flow rate options include High saline flow rate High 6 Medium saline flow rate Medium Low saline flow rate Low Figure 4 9 Adjusting the Saline Flow Rate The three possible saline flow rates are preset for each given RF power setting See Figure A 3 on page A 5 for more detailed information on the saline flow rates for each given RF power setting The saline flow rate setting cannot be adjusted while the Aquamantys disposable bipolar device is activated If a flow rate setting is not manually selected the medium setting is selected as the default setting The Flow Rate Setting Indicator next to the selected flow rate will be illuminated amber to indicate the current flow rate setting Section 5 During Surgery Precautions Warnings Precautions Warnings Precautions This section contains information about Checking the Aquamantys Disposable Bipolar Device Connection Changing the RF Power Setting e Changing the Saline Flow Rate Setting Activating the Aquamantys Disposable Bipolar Device Adjusting the Volume of RF Power Activation Tones Responding to Alarms Read all warnings precautions and instructions provided with this Aquamantys Pump Generator before using Read the warnings precautions and instructions provided with Aquamantys disposable bipolar devices before using Specific instructio
68. t panel LEDs will illuminate momentarily and an audible tone test will sound If the automatic self test is successfully completed after about 6 seconds the RF Power Activation Indicator will illuminate and the RF Power Indicator will display 20 watts If the automatic self test is not successfully completed an alarm will sound the RF power output is disabled and an error code is displayed in the RF Power Indicator Do not attempt to use the Pump Generator and refer to section 8 of this guide If the display shows an alternating HP and Err following the self test the self test was executed while an Aquamantys disposable bipolar device was being activated Simultaneous activation of the device during the self test prevents the audio and visual indicators of the self test from occurring If this happens release the button on the device If all LEDs do not illuminate or the audible tone test is not heard during the automatic self test turn the unit off and then turn the unit back on to cycle it through the self test If this does not resolve the problem do not attempt to use the Aquamantys Pump Generator and refer to section 8 of this guide If you are unable to correct the malfunction use a backup generator or traditional hemostatic techniques to complete the surgical procedure Contact Biomedical Engineering Department or a Salient Surgical Customer Service representative 866 777 9400 in the U S 0808 101 1727 in the U K 1 603
69. ted for activation times of 40 seconds on 80 seconds off for 1 hour With reduced power settings you can activate the unit for greater durations without generating excess internal temperatures Internal Memory During power failures this unit has short time storage of the adjusted values If the power fails for less than 10 seconds the unit will restore the last adjusted working parameters Audio Volume The audio volume level and frequencies of the activation tone and alarm tones meet the requirements of IEC60601 2 2 2006 A 1 A 2 gt gt CAUTION B Activation Tone Frequency nominal 940 Hz Alarm Tone Frequency nominal 349 415 524 698 Hz Leakage Currents See IEC test record LEDs All LEDs inside the Aquamantys are CLASS 1 LED PRODUCT according to EN60825 1 Input Power The nominal mains voltage is factory selected Refer to the rear panel markings for correct mains voltage Nominal Minimum Maximum Max Current Type of fuse Vrms Vrms Vrus Arms 5x20mm 100 90 110 4 00 Glass fine fuse 5x20mm Glass fine fuse 5x20mm TES Glass fine fuse Mains line frequency nominal 50 60 Hz Maximum power consumption 420 VA Mains cable 3 conductor hospital grade 115 127 3 50 Standards and IEC Classifications ATTENTION Consult accompanying documents To reduce the risk of electric shock do not remove the cover Refer servicing to qualified service pe
70. ther active implants If the patient has an internal cardiac defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activations of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Surgery should be performed by persons with adequate training and preparation Personnel should fully understand the nature and use of RF before performing electrosurgical procedures to avoid the risks of shock and burn hazards to both the patient and the operator and damage to the instrumentation Physiological monitoring devices and their monitoring electrodes should be positioned away from the surgical site where the Aquamantys System will be utilized Needle type electrodes are not recommended for use on patients treated with the Aquamantys System Read all warnings precautions and instructions provided with the Aquamantys Pump Generator before using Read the warnings precautions and instructions provided with Aquamantys disposable bipolar devices before using Specific instructions are not included in this manual Always use the lowest RF power setting to achieve the desired surgical effect Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the power and the longer the power is applied the greater the possibility of uni
71. tting 150 100 50 0 100 200 300 400 500 600 700 800 900 1000 Load Ohms Figure A 3 Saline Flow Rate vs Power Setting 32 28 24 20 20 40 60 80 100 120 140 160 180 200 Power Setting watts Figure A 4 Power Setting Characteristics at Rated Load 250 200 150 100 50 0 0 25 50 15 100 125 150 175 200 Power Setting watts A 5 A 6 Accessories Aquamantys System Power Cords Part Region Voltage Length Connectors 30 501 1 North America IEC 60320 C13 to NEMA 5 15 30 502 1 Europe IEC 60320 C13 to Europlug CEE 7 7 30 503 1 Japan IEC 60320 C13 to JIS 8303 30 504 1 United Kingdom 230V 4 5m IEC 60320 C13 to BS 1363 Appendix B New Unit Warranty LIMITED EXPRESS WARRANTY For one 1 year from the date of shipment from Salient Surgical Technologies Inc if an Aquamantys Pump Generator or Cart is found to Salient s satisfaction to be inoperable during normal and proper use in accordance with applicable instructions Salient Surgical Technologies Inc will repair or replace the product at its sole option provided the product is returned freight prepaid in accordance with all return packaging and shipping instructions A product repaired or replaced under this warranty will be warranted for the remainder of the original warranty period SALIENT SURGICAL TE
72. ump segment portion designed to operate with the pump head of the Aquamantys Pump Generator The pump segment portion of the saline delivery tubing is located between a black tubing connector and a white tubing connector The pump head is located on the right side of the Aquamantys Pump Generator when looking at the unit from the front It is best to position yourself facing the right side of the unit to load the pump segment portion of the Aquamantys disposable bipolar device into the pump head 1 Use the black tipped lever located on the right side of the pump head to open the pump head Figure 4 2 Rotate the black tipped lever 180 degrees counterclockwise from the right side of the pump head to the left side of the pump head This action will raise the upper part of the pump head 2 After locating the pump segment portion of the saline delivery tubing on the Aquamantys disposable bipolar device place the pump segment portion of the saline delivery tubing into the pump head with the black tubing connector positioned to the left side of the pump head i e closest to the front panel of the Aquamantys Pump Generator The white tubing connector should then be positioned to the right side of the pump head Figure 4 3 Figure 4 2 Raising the pump head 4 4 Figure 4 3 Placing the pump segment portion of the saline delivery tubing into the pump head White triangle on pump head label Black triangle on pump head label i

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