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_______________________________________________________________________________ SERVICE MANUAL Software Version 1.10...
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Pump Generator Users Guide and in the Instructions for Use which accompany 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 or use by or on Precaution: the order of a physician.
_______________________________________________________________________________ Table of Contents Foreword .......................iii Table of Contents ....................iv List of Tables and Figures..................v Section 1 - Introduction ................... 1-1 General Description ....................1-1 RF Power ......................1-1 Simultaneous RF Power and Saline Delivery............. 1-1 Saline Flow Rate Setting ..................1-1 Priming .......................
_______________________________________________________________________________ List of Tables and Figures Figure 2-1. Front Panel .................... 2-1 Figure 2-2. Rear Panel ..................... 2-1 Figure 3-1. Output Voltage vs. Power Setting ............. 3-6 Figure 3-2. Output Power vs. Resistance..............3-6 Figure 3-3. Saline Flow Rate vs. Power Setting ............3-7 Figure 3-4.
_______________________________________________________________________________ Section 1 - Introduction General Description 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 concurrent delivery of radio-frequency energy with saline for hemostatic sealing of blood vessels in soft tissue and bone.
_______________________________________________________________________________ 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 Figure 2-2. Rear Panel...
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_______________________________________________________________________________ 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.
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_______________________________________________________________________________ Flow Rate Setting Buttons These buttons control the saline flow rate. Pressing one of these three buttons selects the flow rate setting of either 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.
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_______________________________________________________________________________ 14 Name Plate This plate specifies the model number, serial number, nominal line voltages, frequency, current and fuse rating information of the Aquamantys Pump Generator. 15 Fuse Drawer This fuse drawer contains two fuses. The Aquamantys Pump Generator Service Manual contains information for changing fuses.
_______________________________________________________________________________ Symbols Several symbols appear on the Aquamantys Pump Generator front panel, rear panel, and pump head. Symbol Indicates Symbol Indicates This equipment intentionally supplies ATTENTION – Consult non-ionizing RF energy for physiologic accompanying documents effect Volume control of RF power Defibrillation-Proof activation tone.
_______________________________________________________________________________ Activation Tone Frequency (nominal) 940 Hz Alarm Tone Frequency (nominal) 349, 415, 524, 698 Hz Leakage Currents See IEC test record Electromagnetic Compatibility The Aquamantys Pump Generator is intended for use in the electromagnetic environment specified below. The customer or user of the unit should assure that it is used in such an environment.
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_______________________________________________________________________________ Nominal Minimum Maximum Max Current Fuse Type of fuse Rating 5x20mm, 4.00 T5.0A Glass fine fuse 5x20mm, 3.50 T4.0A Glass fine fuse 5x20mm, 1.85 T2.0A Glass fine fuse Mains line frequency (nominal): 50/60 Hz Maximum power consumption: 420 VA Mains cable: 3-conductor hospital grade...
_______________________________________________________________________________ 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 personnel. 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.
_______________________________________________________________________________ Output Characteristics Maximum Pump Generator Outp Mode Maximum Maximum Short Maximum Crest Factor Open Circuit Circuit Current Power Voltage Setting Watts Bipolar 650 (325) 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 50 to 110 ohms...
_______________________________________________________________________________ Figure 3-1. Output Voltage vs. Power Setting Bipolar Vpk Bipolar Vrms Power Setting (Watts) Figure 3-2. Output Power vs. Resistance Bipolar Pow er @ 200 Watt Setting Bipolar Pow er @100 Watt Setting 900 1000 Load (Ohms)
_______________________________________________________________________________ Figure 3-3. Saline Flow Rate vs. Power Setting High Medium Power Setting (Watts) Figure 3-4. Power Setting Characteristics at rated load Power Setting (watts)
Max Current Fuse Type of fuse Rating 5x20mm, Glass 4.00 T5.0A fine fuse 5x20mm, Glass 3.50 T4.0A fine fuse 5x20mm, Glass 1.85 T2.0A fine fuse For a listing of additional Aquamantys System accessories please refer to the TissueLink Medical Product Catalog.
_______________________________________________________________________________ Section 4 - Circuitry Description Overview The Aquamantys Pump Generator is comprised of the following components: • Power supply unit with mains transformer, power supply PCB (Supply_TL1) with rectifiers, filter capacitors and an inrush current limitation circuit. • RF generator PCB (RFGEN_TL1). This PCB comprises the entire internal voltage processing circuit, the RF generator, the motor controller for the peristaltic pump, 2 microcontrollers for sequence control and monitoring the entire process.
_______________________________________________________________________________ Description of unit components Primary power supply Mains voltage reaches the power supply PCB via a line filter socket and an illuminated power switch. The mains transformer connects to this PCB. The mains voltage reaches the mains transformer’s split primary winding via an inrush current limitation circuit and a voltage selector (115 V/230 V).
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_______________________________________________________________________________ The power supply PCB (Supply_TL1) and the mains transformer comprise the power supply unit, which is mounted on an aluminum plate. This power supply unit is fastened in the housing with 4 screws. The mains voltage reaches the Supply_TL1 circuit input (mains socket, J1) via the line filter socket and the power switch.
_______________________________________________________________________________ • LED4: POWER-GOOD. Note: The LEDs protrude over the PCB edge and can be seen after removal of the floor panel. The output socket pin assignment is as follows (starting from fuse FU3): • PIN1 – 2: + / - 160 V, filtered, unregulated •...
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_______________________________________________________________________________ RF Generator Circuit Board (RFGEN_TL1). The RF generator PCB comprises all components of an RF device and also the voltage regulator for the pump motor. Power is fed in via the “from power supply” input on the power supply PCB (Supply_TL1). Fixed voltage regulators reduce the supplied low voltages (+/- 25V) to +5 V (for the microcontrollers and the display) and +/-15 V for the small signal components.
_______________________________________________________________________________ DOWN Aplicator U1_Voltage Output Hf1 / Hf2 RFB0 / RFB1 RF_Generator Regulator T ransform er, Power_Monitor and Filter 0 to 100V Safety_Caps S a fety_T rigge r Circ uit U1_S E T / U1_VAL Switch_Monitor (ST C) Fixed voltages + 5V , + 15V -15V I2C-Bus...
_______________________________________________________________________________ The display circuit board (TL_PM) The display (TL_PM PCB) is connected to the RF generator PCB. Power supply (+5 V) and communication (I²C bus) occur directly from the RF generator PCB. Figure 4-4. Display Board Block Diagram...
Shock Hazards: All servicing should be referred to qualified service personnel. It is recommended that you contact the TissueLink Medical Customer Service Department to have the Aquamantys Pump Generator serviced. Potentially lethal voltages are present within the unit when energized. Use extreme caution if the bottom panel is removed for maintenance or attempted repair.
_______________________________________________________________________________ Section 6 - Maintenance and Repair Responsibility of the Manufacturer TissueLink Medical 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.
_______________________________________________________________________________ Perform leakage and PE conductor tests per the safety tester instructions. The following limits must be complied with in accordance with IEC60601 (Class I, Type CF device): Table 6-1. Leakage Current and PE Conductor Limits Measured Characteristic Maximum Value PE conductor impedance 0.2 Ω...
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_______________________________________________________________________________ RF Output Power Accuracy Verification Warnings: 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.
_______________________________________________________________________________ Peristaltic pump test (function, flow rate accuracy) Warnings: Always close the pump head prior to activating pump motor. Always allow the pump head rotor to come to a complete stop prior to opening the pump head. Prevent fingers or loose clothing from being caught in pump head rotors.
_______________________________________________________________________________ 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.
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 TissueLink Medical Customer Service by calling 866.777.9400 (+1.603.742.1515 outside U.S.).
Before returning the unit to TissueLink Medical, call TissueLink Medical Customer Service for assistance. If you are instructed to send the unit to TissueLink Medical, first obtain a Return Goods Authorization Number and then ship the unit to TissueLink Medical for service.
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Pump Generator from damage. Contact TissueLink Medical for a shipping carton if you do not have comparable packaging. Ship the unit to TissueLink Medical, Inc., One Washington Center, Suite 400, Dover, NH, 03820 USA.
_______________________________________________________________________________ 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: •...
Solution No power No power cord Use power cord shipped with Aquamantys Pump Generator or contact TissueLink Medical Customer Service to obtain new power cord. Wrong power cord utilized Use power cord shipped with Aquamantys Pump Generator or contact TissueLink Medical Customer Service to obtain new power cord.
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Aquamantys disposable bipolar device pump is Guide slots on pump head housing may be out jammed by pump segment connector which of adjustment. Contact TissueLink Medical. has inadvertently entered into pump head. Use a backup unit or traditional hemostatic techniques to complete the surgical procedure.
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Generator doesn’t Pump Generator damaged Contact Biomedical Engineering Department or work a TissueLink 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.
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Wrong fluid used for device irrigation Only utilize 0.9% sodium chloride solution with the Aquamantys System Tip(s) of Aquamantys disposable bipolar Clean device tips with gauze. Ensure device clogged by tissue or coagulated blood precautions are taken to avoid inadvertent device activation when cleaning device tips.
_______________________________________________________________________________ Responding to Alarms When the Aquamantys Pump Generator senses a malfunction, a sequence 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.
_______________________________________________________________________________ Section 8 - Error Codes and Error Handling The Aquamantys Pump Generator self-test, which is executed immediately following power up, comprises several phases. The first phase covers the internal RAM and the MPU0 watchdog test. The second phase tests the major computer hardware components (microcontroller).
_______________________________________________________________________________ Section 9 - Service Access The Aquamantys Pump Generator should only be serviced by a qualified technician. Removal of the bottom cover voids any warranty. Opening the unit To open, turn the unit upside down and remove the floor panel. To do so, remove the screws with a Philips screwdriver and take off the floor panel.
_______________________________________________________________________________ Removing the power supply unit The power supply PCB and the mains transformer – the power supply unit – are mounted on an aluminum plate. After removal of 4 Philips screws the entire power supply unit can be lifted and deposited next to the unit.
_______________________________________________________________________________ Removing the RF generator PCB (RFGEN_TL1) First remove the rear panel and unplug all connectors. 7 nuts hold the RF generator PCB in the housing. Unscrew them, remove the washers and the two serrated washers and carefully lift the PCB out. Make sure during installation (replacement) of the RF generator PCB that the serrated washers are installed in the same positions (bores with copper ring in the PCB) as these serve for equipotential bonding...
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_______________________________________________________________________________ Figure 10-2. Power Supply: Voltage Regulators, Output Stages 10-2...
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_______________________________________________________________________________ Figure 10-3. Power Supply: U1 and U2 Voltage Regulators and Current Limiters 10-3...
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_______________________________________________________________________________ Figure 10-4. Power Supply: Safety Circuits and Analog Conversion 10-4...
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_______________________________________________________________________________ Figure 10-10. System Monitoring: RF Power Measuring 10-10...
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_______________________________________________________________________________ Figure 10-11. System Monitoring: Hand Switch Recog., Analog Control 10-11...
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_______________________________________________________________________________ Figure 10-12. System Monitoring: Hand Switch Test Xfmr 10-12...
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_______________________________________________________________________________ Figure 10-13. Output Control: RF Output, Power Sense Xfmrs 10-13...
Section 11 - Warranty LIMITED EXPRESS WARRANTY For one (1) year from the date of shipment from TissueLink, if an Aquamantys Pump Generator or Cart is found, to TissueLink’s satisfaction, to be inoperable during normal and proper use in accordance with applicable instructions, TissueLink Medical, Inc.